{ "apiVersion": "v1", "contentRevision": "2026-09-13.1000", "reviewedAt": "2026-09-09", "records": [ { "id": "buspar-buspirone", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-09-09", "status": "published_traceable_archive" }, "names": { "brand": "BuSpar", "generic": "盐酸丁螺环酮", "aliases": [ "BUSPAR", "BuSpar", "buspirone", "buspirone hydrochloride", "丁螺环酮", "盐酸丁螺环酮片", "盐酸丁螺环酮" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "精神健康", "sourceArchiveMarket": "美国：BuSpar 历史品牌 NDA 018731；当前仿制品标签单独列示，其他市场待核验。", "dosageFormClass": "口服固体制剂", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "1986-09-29", "archiveSponsorText": "BRISTOL MYERS SQUIBB (historical FDA application)" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [ "BuSpar", "buspirone", "buspirone hydrochloride", "丁螺环酮", "盐酸丁螺环酮" ], "excludedProductCues": [ "bupropion", "安非他酮", "alprazolam", "阿普唑仑" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-buspar-5mg-100-tablet-historical-ndc-0087081841", "marketCode": "US", "labelVersion": { "zh": "FDA 2010-11 历史品牌标签，第 19 页", "en": "Historical FDA brand label, Nov 2010, page 19" }, "dosageForm": { "zh": "盐酸丁螺环酮口服片（历史品牌）", "en": "Buspirone hydrochloride oral tablets (historical brand)" }, "route": { "zh": "口服（历史产品身份字段）", "en": "Oral (historical product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 0087-0818-41", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片盐酸丁螺环酮 5 mg；100 片/瓶（2010 历史记录）", "en": "5 mg buspirone hydrochloride per tablet; 100 tablets/bottle (2010 historical record)" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "盐酸丁螺环酮", "en": "buspirone hydrochloride" }, "value": 5, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标示量，不是个人片数", "en": "Labelled amount per tablet, not an individual tablet count" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-09", "currentLabelDisplayed": false, "ndcDirectoryListed": false, "marketAvailability": "historical_discontinued_rld", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_f1f07aafa8105153", "label": "FDA: BuSpar historical brand label, November 2010, Reference ID 2867200; direct access may be restricted", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018731s051lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_with_site_controls", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-09", "reviewedAt": "2026-09-09" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-buspar-10mg-100-tablet-historical-ndc-0087081941", "marketCode": "US", "labelVersion": { "zh": "FDA 2010-11 历史品牌标签，第 19 页", "en": "Historical FDA brand label, Nov 2010, page 19" }, "dosageForm": { "zh": "盐酸丁螺环酮口服片（历史品牌）", "en": "Buspirone hydrochloride oral tablets (historical brand)" }, "route": { "zh": "口服（历史产品身份字段）", "en": "Oral (historical product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 0087-0819-41", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片盐酸丁螺环酮 10 mg；100 片/瓶（2010 历史记录）", "en": "10 mg buspirone hydrochloride per tablet; 100 tablets/bottle (2010 historical record)" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "盐酸丁螺环酮", "en": "buspirone hydrochloride" }, "value": 10, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标示量，不是个人片数", "en": "Labelled amount per tablet, not an individual tablet count" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-09", "currentLabelDisplayed": false, "ndcDirectoryListed": false, "marketAvailability": "historical_discontinued_rld", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_f1f07aafa8105153", "label": "FDA: BuSpar historical brand label, November 2010, Reference ID 2867200; direct access may be restricted", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018731s051lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_with_site_controls", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-09", "reviewedAt": "2026-09-09" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-buspar-15mg-60-tablet-historical-ndc-0087082232", "marketCode": "US", "labelVersion": { "zh": "FDA 2010-11 历史品牌标签，第 19 页", "en": "Historical FDA brand label, Nov 2010, page 19" }, "dosageForm": { "zh": "盐酸丁螺环酮口服片（历史品牌）", "en": "Buspirone hydrochloride oral tablets (historical brand)" }, "route": { "zh": "口服（历史产品身份字段）", "en": "Oral (historical product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 0087-0822-32", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片盐酸丁螺环酮 15 mg；60 片/瓶（2010 历史记录）", "en": "15 mg buspirone hydrochloride per tablet; 60 tablets/bottle (2010 historical record)" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "盐酸丁螺环酮", "en": "buspirone hydrochloride" }, "value": 15, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标示量，不是个人片数", "en": "Labelled amount per tablet, not an individual tablet count" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-09", "currentLabelDisplayed": false, "ndcDirectoryListed": false, "marketAvailability": "historical_discontinued_rld", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 60, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_f1f07aafa8105153", "label": "FDA: BuSpar historical brand label, November 2010, Reference ID 2867200; direct access may be restricted", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018731s051lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_with_site_controls", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-09", "reviewedAt": "2026-09-09" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-buspar-15mg-180-tablet-historical-ndc-0087082233", "marketCode": "US", "labelVersion": { "zh": "FDA 2010-11 历史品牌标签，第 19 页", "en": "Historical FDA brand label, Nov 2010, page 19" }, "dosageForm": { "zh": "盐酸丁螺环酮口服片（历史品牌）", "en": "Buspirone hydrochloride oral tablets (historical brand)" }, "route": { "zh": "口服（历史产品身份字段）", "en": "Oral (historical product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 0087-0822-33", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片盐酸丁螺环酮 15 mg；180 片/瓶（2010 历史记录）", "en": "15 mg buspirone hydrochloride per tablet; 180 tablets/bottle (2010 historical record)" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "盐酸丁螺环酮", "en": "buspirone hydrochloride" }, "value": 15, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标示量，不是个人片数", "en": "Labelled amount per tablet, not an individual tablet count" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-09", "currentLabelDisplayed": false, "ndcDirectoryListed": false, "marketAvailability": "historical_discontinued_rld", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 180, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_f1f07aafa8105153", "label": "FDA: BuSpar historical brand label, November 2010, Reference ID 2867200; direct access may be restricted", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018731s051lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_with_site_controls", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-09", "reviewedAt": "2026-09-09" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-buspar-30mg-60-tablet-historical-ndc-0087082481", "marketCode": "US", "labelVersion": { "zh": "FDA 2010-11 历史品牌标签，第 19 页", "en": "Historical FDA brand label, Nov 2010, page 19" }, "dosageForm": { "zh": "盐酸丁螺环酮口服片（历史品牌）", "en": "Buspirone hydrochloride oral tablets (historical brand)" }, "route": { "zh": "口服（历史产品身份字段）", "en": "Oral (historical product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 0087-0824-81", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片盐酸丁螺环酮 30 mg；60 片/瓶（2010 历史记录）", "en": "30 mg buspirone hydrochloride per tablet; 60 tablets/bottle (2010 historical record)" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "盐酸丁螺环酮", "en": "buspirone hydrochloride" }, "value": 30, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标示量，不是个人片数", "en": "Labelled amount per tablet, not an individual tablet count" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-09", "currentLabelDisplayed": false, "ndcDirectoryListed": false, "marketAvailability": "historical_discontinued_rld", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 60, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_f1f07aafa8105153", "label": "FDA: BuSpar historical brand label, November 2010, Reference ID 2867200; direct access may be restricted", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018731s051lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_with_site_controls", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-09", "reviewedAt": "2026-09-09" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "status": "withheld_repackaged_or_non_exact_visual", "title": { "zh": "目前仅列历史标签文字，未展示原品牌包装图", "en": "Historical label text only; no verified originator pack image" }, "summary": { "zh": "未完成原品牌包装及分片图示的目视核验。DailyMed 另有 Rising Pharma 通用药包装，不能用来冒充 BuSpar；颜色、刻印相似也不能证明真伪。", "en": "Originator packaging and splitting diagrams have not completed visual review. Rising Pharma generic panels must not stand in for BuSpar; similar appearance cannot authenticate a product." }, "source": { "id": "src_f1f07aafa8105153", "label": "FDA: BuSpar historical brand label, November 2010, Reference ID 2867200; direct access may be restricted", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018731s051lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_with_site_controls", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-09", "reviewedAt": "2026-09-09" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "丁螺环酮说明书大字阅读：先核对完整药单", "en": "Buspirone label reading: start with the whole medicine list" }, "summary": { "zh": "以下安全阅读依据 Rising Pharma 通用药标签，不把它写成 BuSpar 原品牌新说明书。历史品牌 PDF 另列于来源中。阅读时先看准确厂牌、规格和标签日期，再与药师讨论个人用药。", "en": "These safety notes use the distinct Rising Pharma generic label, not an updated BuSpar brand label. The historical brand PDF is listed separately. Check the actual manufacturer, strength and label date with a pharmacist." }, "checks": [ { "zh": "把抗抑郁药、曲普坦类和利奈唑胺等完整列入药单。标签列出 MAOI 联用禁忌及血清素综合征警示，停换及间隔由医疗团队安排。", "en": "Include antidepressants, triptans and linezolid in the medicine list. MAOI contraindications and serotonin-syndrome warnings require clinician-managed treatment changes." }, { "zh": "明显意识改变、高热、肌肉僵硬或抽搐，应及时求助当地急救；网页不能判断是否为血清素综合征。", "en": "Severe confusion, high fever, rigidity or seizures require urgent medical help; a webpage cannot diagnose serotonin syndrome." }, { "zh": "老人中部分人可能更敏感；头晕、站立不稳或嗜睡时注意跌倒和驾驶风险，并联系医疗团队。严重肝肾损害须专业核对。", "en": "Some older adults may be more sensitive. Dizziness, unsteadiness or drowsiness warrants fall/driving precautions and clinical review; severe liver or kidney impairment needs professional assessment." }, { "zh": "药盒的 mg 是每片含量，60 Tablets 是整瓶 60 片。若有不同数字或刻痕，先看手中产品说明书，不从网页自行计算吃几片或掰几份。", "en": "Mg describes strength per tablet; 60 Tablets is the bottle count. Check the actual label before interpreting scores or different figures; do not calculate a personal regimen here." } ], "source": { "id": "src_e536090c802955f0", "label": "DailyMed: Rising Pharma buspirone hydrochloride generic tablets; page updated 2026-03-02, printed issue 02/2025; not BuSpar packaging", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=b9aa144c-cb36-4069-9eaa-7c150298cdd7", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-09", "reviewedAt": "2026-09-09" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "它与常见镇静药有什么不同？", "en": "How does it differ from common sedatives?" }, "summary": { "zh": "2010 年品牌标签指出：确切作用机制尚不明确，体外研究显示对 5-HT1A 受体有较高亲和力；不能把受体名称当成个人疗效预测。", "en": "The historical label says the exact mechanism is unknown and describes high in-vitro affinity for 5-HT1A receptors. Receptor findings do not predict an individual response." }, "checks": [ { "zh": "作用不同：历史标签不把丁螺环酮列为苯二氮䓬类，也不把它作为抗惊厥或肌肉松弛药。用途相近不等于同一种药。", "en": "Different action: the historical label distinguishes buspirone from benzodiazepines and does not attribute anticonvulsant or muscle-relaxant effects to it. A similar use does not mean the same medicine." }, { "zh": "换药前要核对：丁螺环酮不能阻止苯二氮䓬类停药后的戒断反应；不要以它为理由骤停原有镇静或助眠药。", "en": "Before a switch: buspirone does not prevent benzodiazepine withdrawal; do not abruptly stop an existing sedative or sleeping medicine because of it." }, { "zh": "吃饭前后要一致：食物会影响吸收。历史标签要求固定随餐或固定不随餐服用；拿实际产品的当前说明书请药师核对，不要随意交替。", "en": "Keep the food pattern consistent: food affects absorption. The historical label calls for consistent use with food or without food; check the current label for the actual product with a pharmacist rather than alternating." } ], "source": { "id": "src_f1f07aafa8105153", "label": "FDA: BuSpar historical brand label, November 2010, Reference ID 2867200; direct access may be restricted", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018731s051lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_with_site_controls", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-09", "reviewedAt": "2026-09-09" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "BuSpar", "generic": "盐酸丁螺环酮", "dosageFormClass": "口服固体制剂" }, "labelSource": { "id": "src_e536090c802955f0", "label": "DailyMed: Rising Pharma buspirone hydrochloride generic tablets; page updated 2026-03-02, printed issue 02/2025; not BuSpar packaging", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=b9aa144c-cb36-4069-9eaa-7c150298cdd7", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-09", "reviewedAt": "2026-09-09" }, "productRoutes": [ { "source": { "id": "src_e536090c802955f0", "label": "DailyMed: Rising Pharma buspirone hydrochloride generic tablets; page updated 2026-03-02, printed issue 02/2025; not BuSpar packaging", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=b9aa144c-cb36-4069-9eaa-7c150298cdd7", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-09", "reviewedAt": "2026-09-09" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-09-09", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_12fc3bee448dbaba", "label": "FDA Drugs@FDA: BuSpar / buspirone hydrochloride, NDA 018731, historical discontinued RLD tablets", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=018731", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-09", "reviewedAt": "2026-09-09" }, "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-09-09", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_f1f07aafa8105153", "label": "FDA: BuSpar historical brand label, November 2010, Reference ID 2867200; direct access may be restricted", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018731s051lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_with_site_controls", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-09", "reviewedAt": "2026-09-09" }, "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-09-09", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-09-09", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "先认成分：丁螺环酮是处方抗焦虑药，BuSpar 是历史品牌。再认数字：mg 是每片含量，瓶装片数是整瓶数量。最后带完整药单请药师核对，尤其是抗抑郁药、助眠药及利奈唑胺；不要自行停换原有药物。", "history": "FDA 记录 BuSpar 于 1986-09-29 按新分子实体批准。当前 NDA 018731 所列 5、10、15、30 mg 口服片均为停止销售的 RLD，且注明并非因安全性或有效性原因停止销售。2010 年品牌标签仍可作为历史阅读资料；Rising Pharma 的较新通用药标签须作为另一产品单独阅读。", "sourceDocuments": [ { "id": "src_12fc3bee448dbaba", "label": "FDA Drugs@FDA: BuSpar / buspirone hydrochloride, NDA 018731, historical discontinued RLD tablets", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=018731", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-09", "reviewedAt": "2026-09-09" }, { "id": "src_f1f07aafa8105153", "label": "FDA: BuSpar historical brand label, November 2010, Reference ID 2867200; direct access may be restricted", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018731s051lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_with_site_controls", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-09", "reviewedAt": "2026-09-09" }, { "id": "src_e536090c802955f0", "label": "DailyMed: Rising Pharma buspirone hydrochloride generic tablets; page updated 2026-03-02, printed issue 02/2025; not BuSpar packaging", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=b9aa144c-cb36-4069-9eaa-7c150298cdd7", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-09", "reviewedAt": "2026-09-09" } ], "applicationNumber": "NDA 018731", "approvalTimeline": [ { "date": "1986-09-29", "title": { "zh": "美国初始批准", "en": "Initial U.S. approval" }, "detail": { "zh": "FDA 原始申请按新分子实体批准。", "en": "FDA approved the original application as a new molecular entity." }, "source": { "id": "src_12fc3bee448dbaba", "label": "FDA Drugs@FDA: BuSpar / buspirone hydrochloride, NDA 018731, historical discontinued RLD tablets", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=018731", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-09", "reviewedAt": "2026-09-09" } }, { "date": "2010-11-22", "title": { "zh": "历史品牌标签补充批准", "en": "Historical brand labeling supplement" }, "detail": { "zh": "S-051 标签列有五个瓶装及特定 DIVIDOSE 片的患者说明。", "en": "The S-051 label lists five bottle presentations and patient instructions for the specific DIVIDOSE tablets." }, "source": { "id": "src_f1f07aafa8105153", "label": "FDA: BuSpar historical brand label, November 2010, Reference ID 2867200; direct access may be restricted", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018731s051lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_with_site_controls", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-09", "reviewedAt": "2026-09-09" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "历史品牌所列四个强度均停止销售", "en": "Four listed historical brand strengths discontinued" }, "detail": { "zh": "FDA 所列 5、10、15、30 mg 均为 RLD、非 RS；停止销售并不等同于因安全性原因撤回。", "en": "FDA lists 5, 10, 15 and 30 mg as discontinued RLDs, not RS, with a determination that withdrawal was not for safety or effectiveness." } }, { "market": { "zh": "中国大陆", "en": "Mainland China" }, "status": { "zh": "现行市场记录待核验", "en": "Current market record not established" }, "detail": { "zh": "未从美国档案推定中国品牌、批准、规格、供应或可替代性。", "en": "No Chinese brand, approval, strength, supply or interchangeability is inferred from U.S. records." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "药片有刻痕就能自己掰吗？", "en": "Does a score mean I can split it myself?" }, "answer": { "zh": "需看具体产品及处方。2010 年 BuSpar 标签允许特定 5／10 mg 片对半分、特定 15／30 mg DIVIDOSE 片对半或三等分；不能外推到任何厂牌，也不提供个人片数。", "en": "Check the exact product and prescription. The 2010 label describes halves for specific 5/10 mg tablets and halves or thirds for specific 15/30 mg DIVIDOSE tablets, not every manufacturer or an individual regimen." } }, { "question": { "zh": "为什么标签上还有 7.5 mg？", "en": "Why might another label list 7.5 mg?" }, "answer": { "zh": "当前通用药可以有不同规格。这里 NDA 018731 的品牌产品表只有 5、10、15、30 mg；不要把通用药的 7.5 mg 自动补进历史品牌表。", "en": "A generic product may have different strengths. The NDA 018731 brand table here lists 5, 10, 15 and 30 mg; a generic 7.5 mg product must not be inserted into it." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "dose-unit-literacy", "same-class-is-not-same-medicine" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/buspar-buspirone/", "en": "https://origindrug.com/en/drugs/buspar-buspirone/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "motilium-domperidone", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-09-09", "status": "published_traceable_archive" }, "names": { "brand": "Motilium", "generic": "多潘立酮", "aliases": [ "吗丁啉", "吗丁啉®", "多潘立酮片", "domperidone", "Motilium", "多潘立酮" ], "marketBrandNames": [ { "name": "吗丁啉®", "market": { "zh": "中国大陆", "en": "Mainland China" }, "evidenceStatus": "dated_public_record", "note": { "zh": "多潘立酮片，企业公开说明书列国药准字 H10910003。", "en": "Domperidone tablets; the first-party leaflet lists Chinese approval identifier H10910003." }, "source": { "id": "src_02cf937215e6cfe6", "label": "Xi’an Janssen: 吗丁啉 / domperidone tablets OTC leaflet, revised 2026-05-13; H10910003", "url": "https://www.xian-janssen.com.cn/sites/default/files/PDF/%E5%A4%9A%E6%BD%98%E7%AB%8B%E9%85%AE%E7%89%87OTC%E8%AF%B4%E6%98%8E%E4%B9%A6_1.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "first_party_leaflet", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-09", "reviewedAt": "2026-09-09" } }, { "name": "Motilium", "market": { "zh": "爱尔兰", "en": "Ireland" }, "evidenceStatus": "current_regulatory_record", "note": { "zh": "HPRA 许可 PA23490/022/002；不能据此推定其他市场可售。", "en": "HPRA authorisation PA23490/022/002 does not establish sale eligibility elsewhere." }, "source": { "id": "src_2668ced6c37f003a", "label": "HPRA: Motilium 10mg Film-Coated Tablets, Irish authorisation and pharmacy-supply conditions", "url": "https://www.hpra.ie/find-a-medicine/for-human-use/authorised-medicines/details/22237", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "IE", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-09", "reviewedAt": "2026-09-09" } } ], "mainlandChinaTradeNameCue": { "value": "吗丁啉®", "status": "discovery_cue_requires_target_market_verification", "source": { "id": "src_02cf937215e6cfe6", "label": "Xi’an Janssen: 吗丁啉 / domperidone tablets OTC leaflet, revised 2026-05-13; H10910003", "url": "https://www.xian-janssen.com.cn/sites/default/files/PDF/%E5%A4%9A%E6%BD%98%E7%AB%8B%E9%85%AE%E7%89%87OTC%E8%AF%B4%E6%98%8E%E4%B9%A6_1.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "first_party_leaflet", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-09", "reviewedAt": "2026-09-09" } } }, "identity": { "therapeuticArea": "消化系统", "sourceArchiveMarket": "中国大陆：吗丁啉 10 mg 片企业公开说明书；爱尔兰：Motilium 10 mg 薄膜衣片 HPRA 记录。美国未批准人用。", "dosageFormClass": "口服固体制剂", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "美国未批准", "archiveSponsorText": "Xi’an Janssen / JNTL Consumer Health I (Ireland) Limited" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [ "吗丁啉", "多潘立酮", "domperidone", "Motilium" ], "excludedProductCues": [ "metoclopramide", "甲氧氯普胺", "ondansetron", "昂丹司琼" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "cn-motilium-10mg-30-tablets", "marketCode": "CN", "labelVersion": { "zh": "中国企业公开说明书，2026-05-13 修订", "en": "Chinese first-party leaflet, revised 13 May 2026" }, "dosageForm": { "zh": "多潘立酮片", "en": "Domperidone tablets" }, "route": { "zh": "口服（产品身份字段）", "en": "Oral (product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "H10910003", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片多潘立酮 10 mg；30 片/盒", "en": "10 mg domperidone per tablet; 30 tablets/carton" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "多潘立酮", "en": "domperidone" }, "value": 10, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片含量，不是一次应吃的片数", "en": "Strength per tablet, not an individual tablet count" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-09", "currentLabelDisplayed": false, "ndcDirectoryListed": false, "marketAvailability": "label_listed_not_live_supply", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 30, "unit": { "zh": "片/盒", "en": "tablets per carton" } }, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_02cf937215e6cfe6", "label": "Xi’an Janssen: 吗丁啉 / domperidone tablets OTC leaflet, revised 2026-05-13; H10910003", "url": "https://www.xian-janssen.com.cn/sites/default/files/PDF/%E5%A4%9A%E6%BD%98%E7%AB%8B%E9%85%AE%E7%89%87OTC%E8%AF%B4%E6%98%8E%E4%B9%A6_1.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "first_party_leaflet", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-09", "reviewedAt": "2026-09-09" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "cn-motilium-10mg-42-tablets", "marketCode": "CN", "labelVersion": { "zh": "中国企业公开说明书，2026-05-13 修订", "en": "Chinese first-party leaflet, revised 13 May 2026" }, "dosageForm": { "zh": "多潘立酮片", "en": "Domperidone tablets" }, "route": { "zh": "口服（产品身份字段）", "en": "Oral (product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "H10910003", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片多潘立酮 10 mg；42 片/盒", "en": "10 mg domperidone per tablet; 42 tablets/carton" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "多潘立酮", "en": "domperidone" }, "value": 10, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片含量，不是一次应吃的片数", "en": "Strength per tablet, not an individual tablet count" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-09", "currentLabelDisplayed": false, "ndcDirectoryListed": false, "marketAvailability": "label_listed_not_live_supply", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 42, "unit": { "zh": "片/盒", "en": "tablets per carton" } }, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_02cf937215e6cfe6", "label": "Xi’an Janssen: 吗丁啉 / domperidone tablets OTC leaflet, revised 2026-05-13; H10910003", "url": "https://www.xian-janssen.com.cn/sites/default/files/PDF/%E5%A4%9A%E6%BD%98%E7%AB%8B%E9%85%AE%E7%89%87OTC%E8%AF%B4%E6%98%8E%E4%B9%A6_1.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "first_party_leaflet", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-09", "reviewedAt": "2026-09-09" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "ie-motilium-10mg-10-tablets", "marketCode": "IE", "labelVersion": { "zh": "爱尔兰 HPRA，2026-01-26", "en": "Ireland HPRA, 26 Jan 2026" }, "dosageForm": { "zh": "多潘立酮薄膜衣片", "en": "Domperidone film-coated tablets" }, "route": { "zh": "口服（产品身份字段）", "en": "Oral (product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "PA23490/022/002", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片多潘立酮 10 mg；10 片/盒", "en": "10 mg domperidone per tablet; 10 tablets/carton" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "多潘立酮", "en": "domperidone" }, "value": 10, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片含量，不是一次应吃的片数", "en": "Strength per tablet, not an individual tablet count" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-09", "currentLabelDisplayed": false, "ndcDirectoryListed": false, "marketAvailability": "label_listed_not_live_supply", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 10, "unit": { "zh": "片/盒", "en": "tablets per carton" } }, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_0853ccda0505d456", "label": "HPRA: Motilium 10mg Film-Coated Tablets, PA23490/022/002; SmPC 26 January 2026", "url": "https://assets.hpra.ie/products/Human/22237/Licence_PA23490-022-002_26012026113955.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "IE", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-09", "reviewedAt": "2026-09-09" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "ie-motilium-10mg-20-tablets", "marketCode": "IE", "labelVersion": { "zh": "爱尔兰 HPRA，2026-01-26", "en": "Ireland HPRA, 26 Jan 2026" }, "dosageForm": { "zh": "多潘立酮薄膜衣片", "en": "Domperidone film-coated tablets" }, "route": { "zh": "口服（产品身份字段）", "en": "Oral (product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "PA23490/022/002", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片多潘立酮 10 mg；20 片/盒", "en": "10 mg domperidone per tablet; 20 tablets/carton" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "多潘立酮", "en": "domperidone" }, "value": 10, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片含量，不是一次应吃的片数", "en": "Strength per tablet, not an individual tablet count" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-09", "currentLabelDisplayed": false, "ndcDirectoryListed": false, "marketAvailability": "label_listed_not_live_supply", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 20, "unit": { "zh": "片/盒", "en": "tablets per carton" } }, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_0853ccda0505d456", "label": "HPRA: Motilium 10mg Film-Coated Tablets, PA23490/022/002; SmPC 26 January 2026", "url": "https://assets.hpra.ie/products/Human/22237/Licence_PA23490-022-002_26012026113955.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "IE", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-09", "reviewedAt": "2026-09-09" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "status": "withheld_repackaged_or_non_exact_visual", "title": { "zh": "包装数量已核对，外盒照片尚未展示", "en": "Pack counts verified; exact carton photographs not shown" }, "summary": { "zh": "中国说明书列 30 片及 2×21 片；爱尔兰列 10 或 20 片且并非所有包装都在售。未用电商或其他国家包装图代替；外观本身也不能证明真伪。", "en": "China lists 30 and 2×21 tablets; Ireland lists 10 or 20, not necessarily all marketed. Retail or other-country images are not substitutes, and appearance cannot authenticate a pack." }, "source": { "id": "src_02cf937215e6cfe6", "label": "Xi’an Janssen: 吗丁啉 / domperidone tablets OTC leaflet, revised 2026-05-13; H10910003", "url": "https://www.xian-janssen.com.cn/sites/default/files/PDF/%E5%A4%9A%E6%BD%98%E7%AB%8B%E9%85%AE%E7%89%87OTC%E8%AF%B4%E6%98%8E%E4%B9%A6_1.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "first_party_leaflet", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-09", "reviewedAt": "2026-09-09" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "说明书大字阅读：先看年龄、心脏和药单", "en": "Large-print leaflet reading: age, heart history and the medicine list" }, "summary": { "zh": "中国吗丁啉公开说明书（2026-05-13）是这里的首选原件。先核对手中药盒，再看禁忌和注意事项；“非处方药”不等于适合所有人。", "en": "The Chinese Motilium leaflet (13 May 2026) is the primary original here. Match the pack, then read contraindications and precautions; OTC does not mean suitable for everyone." }, "checks": [ { "zh": "60 岁以上、心脏病、肝肾问题或多药合用，请先找医生或药师逐项核对。", "en": "If over 60, with heart, liver or kidney problems, or taking several medicines, ask a clinician or pharmacist to review the whole list." }, { "zh": "中国说明书提示：使用 3 天未缓解应咨询，通常不超过 1 周；这不是让所有人按网页自行开始一个疗程。", "en": "The Chinese leaflet advises consultation if symptoms persist after 3 days and usually limits use to one week; this is not an instruction to start a course." }, { "zh": "出现可能与心律异常有关的症状，说明书要求停用并迅速咨询。晕厥、严重胸部不适或呼吸困难应立即求助当地急救。", "en": "The leaflet calls for stopping and prompt consultation if symptoms may indicate arrhythmia. Fainting, severe chest discomfort or breathing difficulty needs emergency help." }, { "zh": "每片 10 mg 与整盒片数不同。是否能掰片、如何服用，按手中具体说明书和专业意见核对，不能从薄膜衣或外观猜测。", "en": "10 mg per tablet is different from the carton count. Check splitting and administration against the exact leaflet and professional advice, not appearance or coating alone." } ], "source": { "id": "src_02cf937215e6cfe6", "label": "Xi’an Janssen: 吗丁啉 / domperidone tablets OTC leaflet, revised 2026-05-13; H10910003", "url": "https://www.xian-janssen.com.cn/sites/default/files/PDF/%E5%A4%9A%E6%BD%98%E7%AB%8B%E9%85%AE%E7%89%87OTC%E8%AF%B4%E6%98%8E%E4%B9%A6_1.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "first_party_leaflet", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-09", "reviewedAt": "2026-09-09" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "它帮助胃肠运动，不是所有“胃药”都一样", "en": "It helps gut movement; not all stomach medicines do the same thing" }, "summary": { "zh": "爱尔兰说明书解释：多潘立酮阻断多巴胺受体，促进胃排空并有止吐作用；这与减少胃酸分泌不是一回事。", "en": "The Irish SmPC describes dopamine-receptor blockade, faster gastric emptying and anti-emetic effects, rather than reduced acid secretion." }, "checks": [ { "zh": "作用在胃肠道，也可能影响心脏电活动。QT 是心电图上的时间指标，不能靠有没有胃痛判断风险。", "en": "Gut effects do not rule out cardiac electrical effects. QT is an ECG interval; stomach symptoms do not measure that risk." }, { "zh": "身体主要通过 CYP3A4 相关途径处理该药。某些药会干扰这一过程，使血中药量升高；错开一两个小时不能保证解决。", "en": "CYP3A4 contributes to its metabolism. Inhibiting it can raise drug exposure; separating doses by an hour or two is not a reliable solution." }, { "zh": "抗酸或抑酸药不应与其同时服用。让药师按具体药单安排，不从“都是胃药”推断可叠加。", "en": "Antacids and acid-suppressing medicines should not be taken simultaneously with it. A pharmacist should check the actual schedule rather than assume all stomach medicines can be combined." } ], "source": { "id": "src_0853ccda0505d456", "label": "HPRA: Motilium 10mg Film-Coated Tablets, PA23490/022/002; SmPC 26 January 2026", "url": "https://assets.hpra.ie/products/Human/22237/Licence_PA23490-022-002_26012026113955.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "IE", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-09", "reviewedAt": "2026-09-09" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "Motilium", "generic": "多潘立酮", "dosageFormClass": "口服固体制剂" }, "labelSource": { "id": "src_02cf937215e6cfe6", "label": "Xi’an Janssen: 吗丁啉 / domperidone tablets OTC leaflet, revised 2026-05-13; H10910003", "url": "https://www.xian-janssen.com.cn/sites/default/files/PDF/%E5%A4%9A%E6%BD%98%E7%AB%8B%E9%85%AE%E7%89%87OTC%E8%AF%B4%E6%98%8E%E4%B9%A6_1.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "first_party_leaflet", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-09", "reviewedAt": "2026-09-09" }, "productRoutes": [ { "source": { "id": "src_02cf937215e6cfe6", "label": "Xi’an Janssen: 吗丁啉 / domperidone tablets OTC leaflet, revised 2026-05-13; H10910003", "url": "https://www.xian-janssen.com.cn/sites/default/files/PDF/%E5%A4%9A%E6%BD%98%E7%AB%8B%E9%85%AE%E7%89%87OTC%E8%AF%B4%E6%98%8E%E4%B9%A6_1.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "first_party_leaflet", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-09", "reviewedAt": "2026-09-09" }, "status": "manufacturer_public_label_verified", "authority": { "zh": "西安杨森", "en": "Xi’an Janssen" }, "market": { "zh": "中国大陆", "en": "Mainland China" }, "recordType": { "zh": "企业公开说明书", "en": "Manufacturer public leaflet" }, "reviewedAt": "2026-09-09", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_0853ccda0505d456", "label": "HPRA: Motilium 10mg Film-Coated Tablets, PA23490/022/002; SmPC 26 January 2026", "url": "https://assets.hpra.ie/products/Human/22237/Licence_PA23490-022-002_26012026113955.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "IE", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-09", "reviewedAt": "2026-09-09" }, "status": "product_level_public_record_verified", "authority": { "zh": "爱尔兰药监 HPRA", "en": "HPRA" }, "market": { "zh": "爱尔兰", "en": "Ireland" }, "recordType": { "zh": "监管产品记录或公开说明书", "en": "Regulatory product record or public product information" }, "reviewedAt": "2026-09-09", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_2668ced6c37f003a", "label": "HPRA: Motilium 10mg Film-Coated Tablets, Irish authorisation and pharmacy-supply conditions", "url": "https://www.hpra.ie/find-a-medicine/for-human-use/authorised-medicines/details/22237", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "IE", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-09", "reviewedAt": "2026-09-09" }, "status": "product_level_public_record_verified", "authority": { "zh": "爱尔兰药监 HPRA", "en": "HPRA" }, "market": { "zh": "爱尔兰", "en": "Ireland" }, "recordType": { "zh": "监管产品记录或公开说明书", "en": "Regulatory product record or public product information" }, "reviewedAt": "2026-09-09", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "manufacturer_public_label_verified", "authority": { "zh": "西安杨森", "en": "Xi’an Janssen" }, "market": { "zh": "中国大陆", "en": "Mainland China" }, "recordType": { "zh": "企业公开说明书", "en": "Manufacturer public leaflet" }, "reviewedAt": "2026-09-09", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "吗丁啉的成分是多潘立酮，属于胃肠促动力药。10 mg 是每片含量，30 片或 42 片是整盒数量。60 岁以上或正在吃其他药，先把药盒和完整药单交给医生或药师核对。", "history": "EMA 记录该成分在欧洲各国的使用历史，并在 2014 年因心脏风险限制适应症与使用期限。本页分别保留中国 2026-05-13 说明书和爱尔兰 2026-01 HPRA 说明书，不把各国用途、规格或供药条件合成一份全球说明书。", "sourceDocuments": [ { "id": "src_02cf937215e6cfe6", "label": "Xi’an Janssen: 吗丁啉 / domperidone tablets OTC leaflet, revised 2026-05-13; H10910003", "url": "https://www.xian-janssen.com.cn/sites/default/files/PDF/%E5%A4%9A%E6%BD%98%E7%AB%8B%E9%85%AE%E7%89%87OTC%E8%AF%B4%E6%98%8E%E4%B9%A6_1.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "first_party_leaflet", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-09", "reviewedAt": "2026-09-09" }, { "id": "src_0853ccda0505d456", "label": "HPRA: Motilium 10mg Film-Coated Tablets, PA23490/022/002; SmPC 26 January 2026", "url": "https://assets.hpra.ie/products/Human/22237/Licence_PA23490-022-002_26012026113955.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "IE", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-09", "reviewedAt": "2026-09-09" }, { "id": "src_2668ced6c37f003a", "label": "HPRA: Motilium 10mg Film-Coated Tablets, Irish authorisation and pharmacy-supply conditions", "url": "https://www.hpra.ie/find-a-medicine/for-human-use/authorised-medicines/details/22237", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "IE", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-09", "reviewedAt": "2026-09-09" }, { "id": "src_171e9167eada395b", "label": "EMA: domperidone referral and 2014 restrictions on nausea/vomiting use and cardiac risk", "url": "https://www.ema.europa.eu/en/medicines/human/referrals/domperidone-containing-medicines", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "regulatory_guidance", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-09", "reviewedAt": "2026-09-09" }, { "id": "src_4fbd8611c0fd0f3d", "label": "FDA: Information about domperidone; not FDA-approved for human use", "url": "https://www.fda.gov/drugs/information-drug-class/information-about-domperidone", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_guidance", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-09", "reviewedAt": "2026-09-09" } ], "applicationNumber": "CN H10910003 / IE PA23490/022/002", "approvalTimeline": [ { "date": "2007-10-05", "title": { "zh": "爱尔兰本许可首次批准", "en": "First authorisation of this Irish licence" }, "detail": { "zh": "仅为 PA23490/022/002 的日期，不是美国或全球首发日期。", "en": "This date belongs to PA23490/022/002, not U.S. approval or a global first launch." }, "source": { "id": "src_2668ced6c37f003a", "label": "HPRA: Motilium 10mg Film-Coated Tablets, Irish authorisation and pharmacy-supply conditions", "url": "https://www.hpra.ie/find-a-medicine/for-human-use/authorised-medicines/details/22237", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "IE", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-09", "reviewedAt": "2026-09-09" } }, { "date": "2014-04-23", "title": { "zh": "欧洲限制使用建议", "en": "European restrictions endorsed" }, "detail": { "zh": "监管复核支持在限制条件下用于恶心和呕吐，重点关注心脏风险。", "en": "Regulatory review supported restricted nausea/vomiting use with cardiac-risk precautions." }, "source": { "id": "src_171e9167eada395b", "label": "EMA: domperidone referral and 2014 restrictions on nausea/vomiting use and cardiac risk", "url": "https://www.ema.europa.eu/en/medicines/human/referrals/domperidone-containing-medicines", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "regulatory_guidance", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-09", "reviewedAt": "2026-09-09" } }, { "date": "2026-05-13", "title": { "zh": "中国公开说明书修订", "en": "Chinese public leaflet revised" }, "detail": { "zh": "官网当前下载文件列明这一修订日期。", "en": "The current first-party download prints this revision date." }, "source": { "id": "src_02cf937215e6cfe6", "label": "Xi’an Janssen: 吗丁啉 / domperidone tablets OTC leaflet, revised 2026-05-13; H10910003", "url": "https://www.xian-janssen.com.cn/sites/default/files/PDF/%E5%A4%9A%E6%BD%98%E7%AB%8B%E9%85%AE%E7%89%87OTC%E8%AF%B4%E6%98%8E%E4%B9%A6_1.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "first_party_leaflet", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-09", "reviewedAt": "2026-09-09" } } ], "marketStatus": [ { "market": { "zh": "中国大陆", "en": "Mainland China" }, "status": { "zh": "企业公开非处方药说明书", "en": "Public first-party OTC leaflet" }, "detail": { "zh": "吗丁啉／多潘立酮片，10 mg；本次未独立完成 NMPA 当前数据库记录核验，不作库存结论。", "en": "Motilium / domperidone tablets, 10 mg. A separate current NMPA database check is not completed; no stock claim is made." } }, { "market": { "zh": "爱尔兰", "en": "Ireland" }, "status": { "zh": "HPRA 已授权记录；供药条件按包装区分", "en": "HPRA-authorised record; supply conditions vary by pack" }, "detail": { "zh": "本许可小包装可经药房非处方供应；超过 10 片的包装需处方。说明书列包装不等于实时有货。", "en": "The licence permits non-prescription pharmacy supply for the small pack; packs above 10 tablets require a prescription. Listed packs are not live inventory." } }, { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "FDA 未批准人用", "en": "Not FDA-approved for human use" }, "detail": { "zh": "FDA 公开页面明确未批准；不得把其他国家说明书当作美国上市或可购买依据。", "en": "FDA states it is unapproved. Other countries’ leaflets do not establish U.S. marketing or purchasing eligibility." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "中国说明书与爱尔兰用途为什么不同？", "en": "Why do the Chinese and Irish indications differ?" }, "answer": { "zh": "各市场批准范围不同。中国企业产品页列消化不良等症状；爱尔兰当前说明书只列恶心和呕吐。按所在地、具体产品的现行说明书核对，不取更宽的一份自行使用。", "en": "Authorised scope differs by market. The Chinese first-party product page includes dyspepsia symptoms; the current Irish label lists nausea and vomiting. Follow the actual local product, not whichever wording is broader." } }, { "question": { "zh": "能用来催乳吗？", "en": "Can it be used to increase milk supply?" }, "answer": { "zh": "不要自行用于催乳。FDA 提示该用途疗效未确立并有严重心脏风险，停减药也有神经精神不良事件报告；若已在用，请让医疗团队评估。", "en": "Do not self-use it to increase milk supply. FDA describes unestablished benefit, serious cardiac risks and reports of neuropsychiatric events during withdrawal; if already using it, seek clinical review." } }, { "question": { "zh": "掰半就一定变成安全的小剂量吗？", "en": "Does half a tablet guarantee a safer dose?" }, "answer": { "zh": "不是。是否适用、能否分片及该吃多少是不同问题；有禁忌时掰半不能把药变安全。", "en": "No. Suitability, splittability and the prescribed amount are separate questions. Halving does not remove a contraindication." } } ], "relatedMedicineChecks": [ { "target": { "id": "levaquin", "brand": "Levaquin", "generic": "左氧氟沙星", "canonicalUrls": { "zh": "https://origindrug.com/drugs/levaquin/", "en": "https://origindrug.com/en/drugs/levaquin/" } }, "title": { "zh": "药单里还有可乐必妥／左氧氟沙星？", "en": "Also taking levofloxacin / Cravit / Levaquin?" }, "summary": { "zh": "爱尔兰 Motilium 说明书将左氧氟沙星列入不能合用的延长 QT 药物示例。把两盒药交给医生或药师立即核对，不靠错开时间自行处理。", "en": "The Irish Motilium SmPC lists levofloxacin among QT-prolonging medicines contraindicated with domperidone. Have both packs reviewed promptly; do not solve it by self-spacing doses." }, "source": { "id": "src_0853ccda0505d456", "label": "HPRA: Motilium 10mg Film-Coated Tablets, PA23490/022/002; SmPC 26 January 2026", "url": "https://assets.hpra.ie/products/Human/22237/Licence_PA23490-022-002_26012026113955.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "IE", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-09", "reviewedAt": "2026-09-09" } }, { "target": { "id": "biaxin", "brand": "BIAXIN", "generic": "克拉霉素", "canonicalUrls": { "zh": "https://origindrug.com/drugs/biaxin/", "en": "https://origindrug.com/en/drugs/biaxin/" } }, "title": { "zh": "还有克拉霉素等抗感染药？", "en": "Also taking clarithromycin or another anti-infective?" }, "summary": { "zh": "爱尔兰说明书将克拉霉素等强 CYP3A4 抑制剂列为合用禁忌。该清单不是全部相互作用；带完整药单核对。", "en": "The Irish SmPC contraindicates potent CYP3A4 inhibitors such as clarithromycin. This is not an exhaustive interaction list; bring every medicine for review." }, "source": { "id": "src_0853ccda0505d456", "label": "HPRA: Motilium 10mg Film-Coated Tablets, PA23490/022/002; SmPC 26 January 2026", "url": "https://assets.hpra.ie/products/Human/22237/Licence_PA23490-022-002_26012026113955.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "IE", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-09", "reviewedAt": "2026-09-09" } } ], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "dose-unit-literacy", "interactions-are-not-a-home-scheduling-problem" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/motilium-domperidone/", "en": "https://origindrug.com/en/drugs/motilium-domperidone/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "ganaton-itopride", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-09-09", "status": "published_traceable_archive" }, "names": { "brand": "Ganaton / Elthon", "generic": "盐酸伊托必利", "aliases": [ "为力苏", "为力苏®", "盐酸伊托必利片", "伊托必利", "itopride", "itopride hydrochloride", "Elthon", "Ganaton", "ガナトン", "イトプリド", "盐酸伊托必利" ], "marketBrandNames": [ { "name": "为力苏® / Elthon®", "market": { "zh": "中国大陆", "en": "Mainland China" }, "evidenceStatus": "dated_public_record", "note": { "zh": "雅培中国产品页及说明书确认名称与 50 mg 规格。", "en": "Abbott China’s page and leaflet identify the brand and 50 mg strength." }, "source": { "id": "src_04ecbbb9a38a4675", "label": "Abbott China: 为力苏 / Elthon itopride hydrochloride leaflet, front; revised 2025-09-25", "url": "https://www.abbott.com.cn/content/dam/corp/abbott/cn-cn/2026_update/2608/%E4%B8%BA%E5%8A%9B%E8%8B%8F%E8%AF%B4%E6%98%8E%E4%B9%A610-014R7-%E6%AD%A3%E9%9D%A2.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "first_party_leaflet", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-09", "reviewedAt": "2026-09-09" } }, { "name": "ガナトン / Ganaton", "market": { "zh": "日本", "en": "Japan" }, "evidenceStatus": "dated_public_record", "note": { "zh": "PMDA 电子添文列 Ganaton 50 mg，批准编号 20700AMZ00550。", "en": "The PMDA label lists Ganaton 50 mg and authorisation 20700AMZ00550." }, "source": { "id": "src_fcd9749574e45721", "label": "PMDA: Ganaton Tablets 50mg, 20700AMZ00550; electronic label revised July 2024", "url": "https://www.pmda.go.jp/PmdaSearch/bookSearch/01/04987901112499", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-09", "reviewedAt": "2026-09-09" } } ], "mainlandChinaTradeNameCue": { "value": "为力苏®", "status": "discovery_cue_requires_target_market_verification", "source": { "id": "src_04ecbbb9a38a4675", "label": "Abbott China: 为力苏 / Elthon itopride hydrochloride leaflet, front; revised 2025-09-25", "url": "https://www.abbott.com.cn/content/dam/corp/abbott/cn-cn/2026_update/2608/%E4%B8%BA%E5%8A%9B%E8%8B%8F%E8%AF%B4%E6%98%8E%E4%B9%A610-014R7-%E6%AD%A3%E9%9D%A2.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "first_party_leaflet", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-09", "reviewedAt": "2026-09-09" } } }, "identity": { "therapeuticArea": "消化系统", "sourceArchiveMarket": "中国为力苏 50 mg 企业公开说明书；日本 Ganaton 50 mg PMDA 电子添文。品牌、持有人、辅料与批准编号按市场分列。", "dosageFormClass": "口服固体制剂", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "1995（日本销售开始）", "archiveSponsorText": "Abbott Laboratories (M) Sdn. Bhd. / Viatris Japan" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [ "为力苏", "盐酸伊托必利", "伊托必利", "itopride", "Elthon", "Ganaton", "ガナトン" ], "excludedProductCues": [ "domperidone", "多潘立酮", "mosapride", "莫沙必利", "metoclopramide", "甲氧氯普胺" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "jp-ganaton-50mg-100-tablets", "marketCode": "JP", "labelVersion": { "zh": "PMDA 公开电子添文，2024 年 7 月第 4 版", "en": "Public PMDA label, July 2024, fourth revision" }, "dosageForm": { "zh": "盐酸伊托必利薄膜衣片", "en": "Itopride hydrochloride film-coated tablets" }, "route": { "zh": "口服（产品身份字段）", "en": "Oral (product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "20700AMZ00550", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片盐酸伊托必利 50 mg；100 片包装", "en": "50 mg itopride hydrochloride per tablet; 100-tablet pack" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "盐酸伊托必利", "en": "itopride hydrochloride" }, "value": 50, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片含量，不是个人一次用量", "en": "Strength per tablet, not an individual dose" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-09", "currentLabelDisplayed": false, "ndcDirectoryListed": false, "marketAvailability": "label_listed_not_live_supply", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "片/包装", "en": "tablets per pack" } }, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_fcd9749574e45721", "label": "PMDA: Ganaton Tablets 50mg, 20700AMZ00550; electronic label revised July 2024", "url": "https://www.pmda.go.jp/PmdaSearch/bookSearch/01/04987901112499", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-09", "reviewedAt": "2026-09-09" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "jp-ganaton-50mg-1000-tablets", "marketCode": "JP", "labelVersion": { "zh": "PMDA 公开电子添文，2024 年 7 月第 4 版", "en": "Public PMDA label, July 2024, fourth revision" }, "dosageForm": { "zh": "盐酸伊托必利薄膜衣片", "en": "Itopride hydrochloride film-coated tablets" }, "route": { "zh": "口服（产品身份字段）", "en": "Oral (product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "20700AMZ00550", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片盐酸伊托必利 50 mg；1000 片包装", "en": "50 mg itopride hydrochloride per tablet; 1000-tablet pack" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "盐酸伊托必利", "en": "itopride hydrochloride" }, "value": 50, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片含量，不是个人一次用量", "en": "Strength per tablet, not an individual dose" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-09", "currentLabelDisplayed": false, "ndcDirectoryListed": false, "marketAvailability": "label_listed_not_live_supply", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 1000, "unit": { "zh": "片/包装", "en": "tablets per pack" } }, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_fcd9749574e45721", "label": "PMDA: Ganaton Tablets 50mg, 20700AMZ00550; electronic label revised July 2024", "url": "https://www.pmda.go.jp/PmdaSearch/bookSearch/01/04987901112499", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-09", "reviewedAt": "2026-09-09" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "status": "withheld_repackaged_or_non_exact_visual", "title": { "zh": "可核对片剂特征；暂不展示外盒照片", "en": "Tablet features can be checked; exact carton photo not shown" }, "summary": { "zh": "中国原件写白色薄膜衣片；日本写白色、有刻痕、HC803。日本 100／1000 片包装不是中国规格。没有用电商图或其他市场照片代替，外观也不能单独证明真伪。", "en": "China describes a white film-coated tablet; Japan specifies a white scored tablet marked HC803. Japanese 100/1000-tablet packs are not Chinese packs. No retail or other-market photograph is substituted, and appearance alone cannot authenticate a medicine." }, "source": { "id": "src_fcd9749574e45721", "label": "PMDA: Ganaton Tablets 50mg, 20700AMZ00550; electronic label revised July 2024", "url": "https://www.pmda.go.jp/PmdaSearch/bookSearch/01/04987901112499", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-09", "reviewedAt": "2026-09-09" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "说明书大字阅读：先看规格、老人和分片", "en": "Large-print leaflet reading: strength, older adults and splitting" }, "summary": { "zh": "这里先读中国为力苏原件（2025-09-25 修订）。正面列用途、分片和禁忌；反面有老人、相互作用及批准编号，两面需要一起看。", "en": "Start with the Chinese Elthon original, revised 25 September 2025. Its front covers uses, splitting and contraindications; the reverse covers older adults, interactions and approval identifiers. Read both sides." }, "checks": [ { "zh": "每片 50 mg，说明书列 10 片／盒和 20 片／盒；片数是包装数量。一次多少、一天几次仍以你的处方和药师核对为准。", "en": "Each tablet contains 50 mg; the Chinese leaflet lists 10- and 20-tablet cartons. Pack count is not the dose. Confirm your individual amount and schedule against the prescription." }, { "zh": "中国这款说明书允许根据年龄和症状调整时分片服用。先确认医生是否要求分片；不要把这个许可套到所有胃药或缓释、肠溶药。", "en": "This Chinese product’s leaflet permits tablet division when adjusting for age and symptoms. Confirm whether your prescriber intends splitting; this does not apply to every stomach medicine or modified-release product." }, { "zh": "老人更容易出现不良反应，说明书要求留意变化。若头晕、激动或影响反应能力，先避免驾驶等危险活动并联系医生或药师。", "en": "Older adults may be more susceptible to adverse effects. If dizziness, agitation or impaired reactions occur, avoid hazardous activities such as driving and contact your clinician or pharmacist." }, { "zh": "胃肠出血、机械性梗阻或穿孔，以及对本药成分过敏者，不能使用中国这款产品。不要把持续腹痛或反复呕吐都当成“胃动力差”。", "en": "The Chinese product is contraindicated with gastrointestinal bleeding, mechanical obstruction, perforation or allergy to its ingredients. Persistent pain or vomiting should not simply be treated as poor gut motility." }, { "zh": "严重过敏可出现呼吸困难、喉头肿胀或晕厥，应立即求助急救；出现黄疸等异常应尽快就医。", "en": "Breathing difficulty, throat swelling or fainting with a severe allergic reaction requires emergency help; jaundice or other concerning changes require prompt assessment." } ], "source": { "id": "src_04ecbbb9a38a4675", "label": "Abbott China: 为力苏 / Elthon itopride hydrochloride leaflet, front; revised 2025-09-25", "url": "https://www.abbott.com.cn/content/dam/corp/abbott/cn-cn/2026_update/2608/%E4%B8%BA%E5%8A%9B%E8%8B%8F%E8%AF%B4%E6%98%8E%E4%B9%A610-014R7-%E6%AD%A3%E9%9D%A2.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "first_party_leaflet", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-09", "reviewedAt": "2026-09-09" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "帮助胃肠推动内容物，不等于抑酸药", "en": "Helps gut movement; it is not an acid suppressant" }, "summary": { "zh": "伊托必利让乙酰胆碱这一“运动信号”更容易发挥作用：一方面阻断多巴胺 D2 受体，另一方面减少乙酰胆碱被分解，从而促进胃肠运动。", "en": "Itopride supports the acetylcholine signals that drive gut movement by blocking dopamine D2 receptors and reducing acetylcholine breakdown." }, "checks": [ { "zh": "它与多潘立酮、莫沙必利不是同一个成分。“都促进胃动力”不代表可以自行叠加、轮换或按 mg 替换。", "en": "It is not domperidone or mosapride. A shared prokinetic purpose does not justify combining, alternating or converting doses yourself." }, { "zh": "抗胆碱药可能抵消部分作用；促进胃肠运动还可能影响其他口服药的吸收，尤其要核对治疗窗窄、缓释或肠溶产品。", "en": "Anticholinergics may reduce its effect. Changed gut movement can also affect absorption of other oral medicines, especially narrow-therapeutic-index, prolonged-release or enteric-coated products." }, { "zh": "主要通过 FMO 相关途径代谢，不等于“没有相互作用”。中国说明书还提醒 QT 间期延长、肝功能异常等风险。", "en": "Predominant FMO-related metabolism does not mean no interactions. The Chinese leaflet also warns about QT prolongation and abnormal liver function." } ], "source": { "id": "src_e025b7d9b81710cd", "label": "Abbott China: 为力苏 / Elthon leaflet, reverse; older adults, interactions and approval identifiers", "url": "https://www.abbott.com.cn/content/dam/corp/abbott/cn-cn/2026_update/2608/%E4%B8%BA%E5%8A%9B%E8%8B%8F%E8%AF%B4%E6%98%8E%E4%B9%A610-014R7-%E5%8F%8D%E9%9D%A2.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "first_party_leaflet", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-09", "reviewedAt": "2026-09-09" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "Ganaton / Elthon", "generic": "盐酸伊托必利", "dosageFormClass": "口服固体制剂" }, "labelSource": { "id": "src_04ecbbb9a38a4675", "label": "Abbott China: 为力苏 / Elthon itopride hydrochloride leaflet, front; revised 2025-09-25", "url": "https://www.abbott.com.cn/content/dam/corp/abbott/cn-cn/2026_update/2608/%E4%B8%BA%E5%8A%9B%E8%8B%8F%E8%AF%B4%E6%98%8E%E4%B9%A610-014R7-%E6%AD%A3%E9%9D%A2.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "first_party_leaflet", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-09", "reviewedAt": "2026-09-09" }, "productRoutes": [ { "source": { "id": "src_04ecbbb9a38a4675", "label": "Abbott China: 为力苏 / Elthon itopride hydrochloride leaflet, front; revised 2025-09-25", "url": "https://www.abbott.com.cn/content/dam/corp/abbott/cn-cn/2026_update/2608/%E4%B8%BA%E5%8A%9B%E8%8B%8F%E8%AF%B4%E6%98%8E%E4%B9%A610-014R7-%E6%AD%A3%E9%9D%A2.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "first_party_leaflet", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-09", "reviewedAt": "2026-09-09" }, "status": "manufacturer_public_label_verified", "authority": { "zh": "雅培中国", "en": "Abbott China" }, "market": { "zh": "中国大陆", "en": "Mainland China" }, "recordType": { "zh": "企业公开说明书", "en": "Manufacturer public leaflet" }, "reviewedAt": "2026-09-09", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_e025b7d9b81710cd", "label": "Abbott China: 为力苏 / Elthon leaflet, reverse; older adults, interactions and approval identifiers", "url": "https://www.abbott.com.cn/content/dam/corp/abbott/cn-cn/2026_update/2608/%E4%B8%BA%E5%8A%9B%E8%8B%8F%E8%AF%B4%E6%98%8E%E4%B9%A610-014R7-%E5%8F%8D%E9%9D%A2.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "first_party_leaflet", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-09", "reviewedAt": "2026-09-09" }, "status": "manufacturer_public_label_verified", "authority": { "zh": "雅培中国", "en": "Abbott China" }, "market": { "zh": "中国大陆", "en": "Mainland China" }, "recordType": { "zh": "企业公开说明书", "en": "Manufacturer public leaflet" }, "reviewedAt": "2026-09-09", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_fcd9749574e45721", "label": "PMDA: Ganaton Tablets 50mg, 20700AMZ00550; electronic label revised July 2024", "url": "https://www.pmda.go.jp/PmdaSearch/bookSearch/01/04987901112499", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-09", "reviewedAt": "2026-09-09" }, "status": "product_level_public_record_verified", "authority": { "zh": "PMDA", "en": "PMDA" }, "market": { "zh": "日本", "en": "Japan" }, "recordType": { "zh": "监管产品记录", "en": "Regulatory product record" }, "reviewedAt": "2026-09-09", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "manufacturer_public_label_verified", "authority": { "zh": "雅培中国", "en": "Abbott China" }, "market": { "zh": "中国大陆", "en": "Mainland China" }, "recordType": { "zh": "企业公开说明书", "en": "Manufacturer public leaflet" }, "reviewedAt": "2026-09-09", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "为力苏的成分是盐酸伊托必利，是帮助胃肠运动的药。50 mg 是每片的成分含量，不是整盒重量，也不是所有人一次该吃的量。老人或同时服多种药，先核对完整药单和医生给的用法。", "history": "日本 PMDA 标签记载 Ganaton 于 1995 年 9 月开始销售；中国雅培当前公开为力苏说明书的最新印载修订日期为 2025-09-25。这里保留两个市场各自的原件，不把国外批准范围或包装移植到中国。", "sourceDocuments": [ { "id": "src_04ecbbb9a38a4675", "label": "Abbott China: 为力苏 / Elthon itopride hydrochloride leaflet, front; revised 2025-09-25", "url": "https://www.abbott.com.cn/content/dam/corp/abbott/cn-cn/2026_update/2608/%E4%B8%BA%E5%8A%9B%E8%8B%8F%E8%AF%B4%E6%98%8E%E4%B9%A610-014R7-%E6%AD%A3%E9%9D%A2.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "first_party_leaflet", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-09", "reviewedAt": "2026-09-09" }, { "id": "src_e025b7d9b81710cd", "label": "Abbott China: 为力苏 / Elthon leaflet, reverse; older adults, interactions and approval identifiers", "url": "https://www.abbott.com.cn/content/dam/corp/abbott/cn-cn/2026_update/2608/%E4%B8%BA%E5%8A%9B%E8%8B%8F%E8%AF%B4%E6%98%8E%E4%B9%A610-014R7-%E5%8F%8D%E9%9D%A2.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "first_party_leaflet", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-09", "reviewedAt": "2026-09-09" }, { "id": "src_fcd9749574e45721", "label": "PMDA: Ganaton Tablets 50mg, 20700AMZ00550; electronic label revised July 2024", "url": "https://www.pmda.go.jp/PmdaSearch/bookSearch/01/04987901112499", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-09", "reviewedAt": "2026-09-09" }, { "id": "src_15a9694f3270822b", "label": "Abbott China: digestive products and current Elthon leaflet downloads", "url": "https://www.abbott.com.cn/for-professionals/pharmaceuticals/Digestion.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "manufacturer_product_record", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-09", "reviewedAt": "2026-09-09" } ], "applicationNumber": "JP 20700AMZ00550; CN leaflet lists HJ20160414 / HJ20160415", "approvalTimeline": [ { "date": "1995-09", "title": { "zh": "日本 Ganaton 开始销售", "en": "Ganaton sales began in Japan" }, "detail": { "zh": "日本标签记载的本市场销售日期，不是全球首发结论。", "en": "A market-specific sales date printed in the Japanese label, not a global-first claim." }, "source": { "id": "src_fcd9749574e45721", "label": "PMDA: Ganaton Tablets 50mg, 20700AMZ00550; electronic label revised July 2024", "url": "https://www.pmda.go.jp/PmdaSearch/bookSearch/01/04987901112499", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-09", "reviewedAt": "2026-09-09" } }, { "date": "2025-09-25", "title": { "zh": "中国为力苏说明书修订", "en": "Chinese Elthon leaflet revised" }, "detail": { "zh": "本次从雅培现行产品页打开的正反面文件，编号 10-014R7。", "en": "The front and reverse reached from Abbott’s current product page carry artwork code 10-014R7." }, "source": { "id": "src_04ecbbb9a38a4675", "label": "Abbott China: 为力苏 / Elthon itopride hydrochloride leaflet, front; revised 2025-09-25", "url": "https://www.abbott.com.cn/content/dam/corp/abbott/cn-cn/2026_update/2608/%E4%B8%BA%E5%8A%9B%E8%8B%8F%E8%AF%B4%E6%98%8E%E4%B9%A610-014R7-%E6%AD%A3%E9%9D%A2.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "first_party_leaflet", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-09", "reviewedAt": "2026-09-09" } } ], "marketStatus": [ { "market": { "zh": "中国大陆", "en": "Mainland China" }, "status": { "zh": "企业公开说明书已核对", "en": "First-party public leaflet checked" }, "detail": { "zh": "说明书列两项批准编号 HJ20160414／HJ20160415，以及 10／20 片包装，但未逐一映射编号与包装；本页不自行配对，也未完成独立的 NMPA 当前记录核验。", "en": "The leaflet lists HJ20160414/HJ20160415 and 10/20-tablet cartons without mapping each identifier to a pack. No pairing is invented, and a separate current NMPA database check is not completed." } }, { "market": { "zh": "日本", "en": "Japan" }, "status": { "zh": "PMDA 公开电子添文已核对", "en": "Public PMDA electronic label checked" }, "detail": { "zh": "原件修订日期为 2024 年 7 月，列 50 mg、100／1000 片包装；核查访问日期不改写为说明书修订日期，也不代表实时库存。", "en": "The original is revised July 2024 and lists 50 mg in 100/1000-tablet packs. Access verification is not a new label revision or live inventory check." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "50 mg 是药片总重量吗？", "en": "Is 50 mg the total tablet weight?" }, "answer": { "zh": "不是，是每片盐酸伊托必利的标示含量。日本标签另外列整片重量 130 mg，其中还包含辅料；130 mg 不是更大剂量的伊托必利。", "en": "No. It is the labelled itopride hydrochloride content per tablet. The Japanese label separately gives a 130 mg tablet weight including excipients; that does not mean a 130 mg itopride dose." } }, { "question": { "zh": "有刻痕，就能自己减半吃吗？", "en": "Does a score mean I should halve my dose?" }, "answer": { "zh": "能否分片与该吃多少是两件事。中国为力苏说明书允许在调整剂量时分片，但是否调整由医生结合情况决定。其他厂牌须另核说明书。", "en": "Whether a tablet can be divided and what dose you need are separate questions. The Chinese Elthon leaflet permits division for dose adjustment, but the clinical decision is individual. Check other brands separately." } }, { "question": { "zh": "“胃药”是不是可以长期自行吃？", "en": "Can I keep taking it indefinitely as a stomach medicine?" }, "answer": { "zh": "不能这样理解。中国说明书提示尚无长期用药数据，用药两周后症状改善不明显时宜停药；请联系开方团队复评，不自行加量或叠加别的促动力药。", "en": "No. The Chinese leaflet notes the lack of long-term use data and advises discontinuation if improvement is unclear after two weeks. Contact the prescribing team for reassessment rather than increasing or adding another prokinetic yourself." } } ], "relatedMedicineChecks": [ { "target": { "id": "motilium-domperidone", "brand": "Motilium", "generic": "多潘立酮", "canonicalUrls": { "zh": "https://origindrug.com/drugs/motilium-domperidone/", "en": "https://origindrug.com/en/drugs/motilium-domperidone/" } }, "title": { "zh": "还有吗丁啉／多潘立酮？", "en": "Also using Motilium / domperidone?" }, "summary": { "zh": "两者成分不同。用途相近不能推出适合叠加或轮换；把实际药盒、服药时间和症状交给医生或药师核对，不由网页判断个人联合用药。", "en": "These contain different ingredients. Similar uses do not establish suitability for combination or alternation; have the actual packs, schedule and symptoms reviewed professionally." }, "source": { "id": "src_e025b7d9b81710cd", "label": "Abbott China: 为力苏 / Elthon leaflet, reverse; older adults, interactions and approval identifiers", "url": "https://www.abbott.com.cn/content/dam/corp/abbott/cn-cn/2026_update/2608/%E4%B8%BA%E5%8A%9B%E8%8B%8F%E8%AF%B4%E6%98%8E%E4%B9%A610-014R7-%E5%8F%8D%E9%9D%A2.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "first_party_leaflet", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-09", "reviewedAt": "2026-09-09" } } ], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "dose-unit-literacy", "interactions-are-not-a-home-scheduling-problem" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/ganaton-itopride/", "en": "https://origindrug.com/en/drugs/ganaton-itopride/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "methycobal-mecobalamin", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-09-09", "status": "published_traceable_archive" }, "names": { "brand": "Methycobal", "generic": "甲钴胺", "aliases": [ "弥可保", "弥可保®", "甲钴胺片", "mecobalamin", "methylcobalamin", "Methycobal", "メチコバール", "メコバラミン", "甲钴胺" ], "marketBrandNames": [ { "name": "メチコバール / Methycobal", "market": { "zh": "日本", "en": "Japan" }, "evidenceStatus": "dated_public_record", "note": { "zh": "日本原件按 250 μg、500 μg 片及细粒分栏。", "en": "The Japanese original separates 250/500 microgram tablets from fine granules." }, "source": { "id": "src_7c9713671b8dcd2b", "label": "PMDA: Methycobal tablets 250 / 500 micrograms and fine granules; April 2023 label", "url": "https://www.pmda.go.jp/PmdaSearch/iyakuDetail/ResultDataSetPDF/170033_3136004C1038_1_05", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-09", "reviewedAt": "2026-09-09" } }, { "name": "METHYCOBAL", "market": { "zh": "新加坡", "en": "Singapore" }, "evidenceStatus": "dated_public_record", "note": { "zh": "政府记录为 500 MCG 糖衣片，注册号 SIN06291P；持有人为 EISAI (SINGAPORE)。", "en": "The government record identifies a 500 MCG sugar-coated tablet, SIN06291P, held by EISAI (SINGAPORE)." }, "source": { "id": "src_a992c72834568e24", "label": "Singapore National Drug Formulary: METHYCOBAL TABLET 500 MCG, SIN06291P; updated 28 July 2026", "url": "https://www.ndf.gov.sg/about-drugs/product-information/sin06291p/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "regulatory_product_record", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-09", "reviewedAt": "2026-09-09" } }, { "name": "弥可保®", "market": { "zh": "中国大陆", "en": "Mainland China" }, "evidenceStatus": "historical_public_record", "note": { "zh": "2018 年企业公告中的品牌线索，不能替代中国现行说明书。", "en": "A brand clue from a 2018 company announcement, not a current Chinese leaflet." }, "source": { "id": "src_d7b4630f312c3983", "label": "Eisai China: Suzhou oral solid-dose factory announcement, 11 January 2018; historical Methycobal brand evidence", "url": "https://www.eisai.com.cn/2018/01/11/%E5%8D%AB%E6%9D%90%E4%BD%8D%E4%BA%8E%E4%B8%AD%E5%9B%BD%E8%8B%8F%E5%B7%9E%E6%96%B0%E5%B7%A5%E5%8E%82%E7%9A%84%E5%8F%A3%E6%9C%8D%E5%9B%BA%E4%BD%93%E5%88%B6%E5%89%82%E5%8E%82%E6%88%BF%E7%AB%A3%E5%B7%A5/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "manufacturer_product_record", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-09", "reviewedAt": "2026-09-09" } } ], "mainlandChinaTradeNameCue": { "value": "弥可保®", "status": "discovery_cue_requires_target_market_verification", "source": { "id": "src_d7b4630f312c3983", "label": "Eisai China: Suzhou oral solid-dose factory announcement, 11 January 2018; historical Methycobal brand evidence", "url": "https://www.eisai.com.cn/2018/01/11/%E5%8D%AB%E6%9D%90%E4%BD%8D%E4%BA%8E%E4%B8%AD%E5%9B%BD%E8%8B%8F%E5%B7%9E%E6%96%B0%E5%B7%A5%E5%8E%82%E7%9A%84%E5%8F%A3%E6%9C%8D%E5%9B%BA%E4%BD%93%E5%88%B6%E5%89%82%E5%8E%82%E6%88%BF%E7%AB%A3%E5%B7%A5/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "manufacturer_product_record", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-09", "reviewedAt": "2026-09-09" } } }, "identity": { "therapeuticArea": "神经与认知", "sourceArchiveMarket": "本页阅读日本口服片说明书，另列新加坡 500 μg 产品记录。中国弥可保仅有企业历史品牌资料，不代表已核实中国现行说明书、规格或批准状态。", "dosageFormClass": "口服固体制剂", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "1981（日本 500 μg 片销售开始）", "archiveSponsorText": "Eisai" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [ "甲钴胺", "弥可保", "Methycobal", "mecobalamin", "methylcobalamin", "メチコバール" ], "excludedProductCues": [ "cyanocobalamin", "氰钴胺", "hydroxocobalamin", "羟钴胺", "cobamamide", "腺苷钴胺", "Rozebalamin", "ロゼバラミン" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "jp-methycobal-250mcg-100-tablets", "marketCode": "JP", "labelVersion": { "zh": "PMDA 电子添文，2023 年 4 月第 1 版", "en": "PMDA electronic label, April 2023, first revision" }, "dosageForm": { "zh": "甲钴胺糖衣片", "en": "Mecobalamin sugar-coated tablets" }, "route": { "zh": "口服（产品身份字段）", "en": "Oral (product identity)" }, "routeCodes": [ "oral" ], "productCode": "15400AMZ01326000", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片甲钴胺 250 μg；100 片包装", "en": "250 micrograms mecobalamin per tablet; 100-tablet pack" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "甲钴胺", "en": "mecobalamin" }, "value": 250, "unit": "μg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片含量，不是个人一次用量", "en": "Strength per tablet, not an individual dose" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-09", "currentLabelDisplayed": false, "ndcDirectoryListed": false, "marketAvailability": "label_listed_not_live_supply", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "片/包装", "en": "tablets per pack" } }, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_7c9713671b8dcd2b", "label": "PMDA: Methycobal tablets 250 / 500 micrograms and fine granules; April 2023 label", "url": "https://www.pmda.go.jp/PmdaSearch/iyakuDetail/ResultDataSetPDF/170033_3136004C1038_1_05", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-09", "reviewedAt": "2026-09-09" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "jp-methycobal-500mcg-100-tablets", "marketCode": "JP", "labelVersion": { "zh": "PMDA 电子添文，2023 年 4 月第 1 版", "en": "PMDA electronic label, April 2023, first revision" }, "dosageForm": { "zh": "甲钴胺糖衣片", "en": "Mecobalamin sugar-coated tablets" }, "route": { "zh": "口服（产品身份字段）", "en": "Oral (product identity)" }, "routeCodes": [ "oral" ], "productCode": "15400AMZ01327000", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片甲钴胺 500 μg；100 片包装", "en": "500 micrograms mecobalamin per tablet; 100-tablet pack" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "甲钴胺", "en": "mecobalamin" }, "value": 500, "unit": "μg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片含量，不是个人一次用量", "en": "Strength per tablet, not an individual dose" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-09", "currentLabelDisplayed": false, "ndcDirectoryListed": false, "marketAvailability": "label_listed_not_live_supply", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "片/包装", "en": "tablets per pack" } }, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_7c9713671b8dcd2b", "label": "PMDA: Methycobal tablets 250 / 500 micrograms and fine granules; April 2023 label", "url": "https://www.pmda.go.jp/PmdaSearch/iyakuDetail/ResultDataSetPDF/170033_3136004C1038_1_05", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-09", "reviewedAt": "2026-09-09" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "status": "withheld_repackaged_or_non_exact_visual", "title": { "zh": "原件有日本片剂图；本页不冒用外盒照片", "en": "Japanese tablet images are in the original; no substitute carton photo" }, "summary": { "zh": "可从日本患者指南核对片剂外观。这里未取得与具体包装对应的外盒照片，不用电商图、注射剂或别国包装代替；外观不能单独证明真伪。", "en": "Use the Japanese patient guide to inspect tablet appearance. No exact carton photograph has been verified here. Retail, injection or other-market images are not substituted; appearance alone cannot authenticate medicine." }, "source": { "id": "src_839ae851935d166d", "label": "PMDA: Methycobal patient guide, May 2026", "url": "https://www.info.pmda.go.jp/downfiles/ph/GUI/170033_3136004C1038_1_00GW/170033_3136004C1038_1_00GW.htm", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "patient_medication_guide", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-09", "reviewedAt": "2026-09-09" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "说明书大字阅读：先认单位，再核对用法", "en": "Large-print leaflet reading: units before tablet counts" }, "summary": { "zh": "日本电子说明书是 2023 年 4 月版，患者指南是 2026 年 5 月版；两者用途不同。中国药盒请另核中国原件，本页不把访问日期写成说明书修订日期。", "en": "The Japanese label is dated April 2023 and its patient guide May 2026. They serve different purposes. Check the Chinese original for a Chinese pack; access dates are not revision dates." }, "checks": [ { "zh": "μg（也写 mcg）是微克；mg 是毫克。500 μg = 0.5 mg，250 μg = 0.25 mg。单位换算只解释含量，不自动生成片数。", "en": "μg (also mcg) means micrograms; mg means milligrams. 500 μg = 0.5 mg and 250 μg = 0.25 mg. Unit conversion explains strength, not your tablet count." }, { "zh": "先把处方上的“每次用量、每天次数”和实际规格一起交给药师核对。不要只见“半毫克”就掰片，也不要把注射液或细粒按片数替换。", "en": "Have the prescribed amount, frequency and actual strength checked together. “Half a milligram” is not an instruction to halve a tablet or substitute injections or granules." }, { "zh": "日本说明书提醒：看不到效果时不应漫无目的地用上一个多月。请安排复评，而不是自行加量或把所有麻木都当作缺维生素。", "en": "The Japanese label cautions against continuing for over a month without benefit. Arrange reassessment rather than increasing the dose or assuming all numbness is vitamin deficiency." }, { "zh": "日本患者指南列出食欲下降、恶心、呕吐、腹泻等可能反应；不舒服或出现和平时不同的症状时，联系医生或药师。", "en": "The Japanese patient guide lists appetite loss, nausea, vomiting and diarrhoea among possible effects. Contact a clinician or pharmacist about new or unusual symptoms." }, { "zh": "药片要从泡罩中取出再服用，不能连同剪下的小格包装吞下。日本指南要求避光、防潮保存；实际药盒的保管说明仍要核对。", "en": "Remove the tablet from its blister before swallowing; never swallow a cut-out blister cell. The Japanese guide advises protection from light and moisture; check your actual pack’s storage directions." } ], "source": { "id": "src_7c9713671b8dcd2b", "label": "PMDA: Methycobal tablets 250 / 500 micrograms and fine granules; April 2023 label", "url": "https://www.pmda.go.jp/PmdaSearch/iyakuDetail/ResultDataSetPDF/170033_3136004C1038_1_05", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-09", "reviewedAt": "2026-09-09" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "参与神经细胞代谢，不是“多吃就能补好神经”", "en": "Supports cellular metabolism; more does not mean better nerves" }, "summary": { "zh": "甲钴胺是维生素 B12 的一种形式，用于周围神经病。它像细胞代谢的“助手”，帮助身体完成神经细胞需要的化学反应；不等于一吃就能立即止痛。", "en": "Mecobalamin is a form of vitamin B12 used for peripheral neuropathies. It helps chemical processes needed by nerve cells; it is not a promise of immediate pain relief." }, "checks": [ { "zh": "进一步看机制：它作为酶的“助手”，参与把同型半胱氨酸转为蛋氨酸的反应。这不是根据某一项化验自行选药的依据。", "en": "In more detail, it acts as an enzyme helper in converting homocysteine to methionine. This is not a basis for selecting treatment from a single laboratory result." }, { "zh": "药理机制不能证明你的麻木原因，也不能据此决定疗程；是否适用需要结合诊断。", "en": "A mechanism does not identify the cause of your numbness or determine treatment duration; suitability depends on diagnosis." }, { "zh": "“都叫 B12”不等于产品相同。把复合维生素、其他 B12 制剂及全部药盒一起核对，避免漏报或重复使用。", "en": "A B12 label does not make products identical. Review multivitamins, other B12 preparations and all medicine packs together to avoid omissions or duplication." }, { "zh": "患者指南要求到其他医院就诊或另买药时告知正在使用本药。网页不根据“维生素”三个字判断联合用药安全。", "en": "The patient guide asks users to disclose this medicine at other clinics or when buying other medicines. This site does not infer combination safety from the word vitamin." } ], "source": { "id": "src_7c9713671b8dcd2b", "label": "PMDA: Methycobal tablets 250 / 500 micrograms and fine granules; April 2023 label", "url": "https://www.pmda.go.jp/PmdaSearch/iyakuDetail/ResultDataSetPDF/170033_3136004C1038_1_05", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-09", "reviewedAt": "2026-09-09" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "Methycobal", "generic": "甲钴胺", "dosageFormClass": "口服固体制剂" }, "labelSource": { "id": "src_7c9713671b8dcd2b", "label": "PMDA: Methycobal tablets 250 / 500 micrograms and fine granules; April 2023 label", "url": "https://www.pmda.go.jp/PmdaSearch/iyakuDetail/ResultDataSetPDF/170033_3136004C1038_1_05", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-09", "reviewedAt": "2026-09-09" }, "productRoutes": [ { "source": { "id": "src_7c9713671b8dcd2b", "label": "PMDA: Methycobal tablets 250 / 500 micrograms and fine granules; April 2023 label", "url": "https://www.pmda.go.jp/PmdaSearch/iyakuDetail/ResultDataSetPDF/170033_3136004C1038_1_05", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-09", "reviewedAt": "2026-09-09" }, "status": "product_level_public_record_verified", "authority": { "zh": "PMDA", "en": "PMDA" }, "market": { "zh": "日本", "en": "Japan" }, "recordType": { "zh": "监管产品记录", "en": "Regulatory product record" }, "reviewedAt": "2026-09-09", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_a992c72834568e24", "label": "Singapore National Drug Formulary: METHYCOBAL TABLET 500 MCG, SIN06291P; updated 28 July 2026", "url": "https://www.ndf.gov.sg/about-drugs/product-information/sin06291p/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "regulatory_product_record", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-09", "reviewedAt": "2026-09-09" }, "status": "product_level_public_record_verified", "authority": { "zh": "新加坡国家药物目录 NDF", "en": "Singapore National Drug Formulary (NDF)" }, "market": { "zh": "新加坡", "en": "Singapore" }, "recordType": { "zh": "政府药物目录产品资料与说明书节选", "en": "Government drug formulary product information and leaflet excerpts" }, "reviewedAt": "2026-09-09", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "PMDA", "en": "PMDA" }, "market": { "zh": "日本", "en": "Japan" }, "recordType": { "zh": "监管产品记录", "en": "Regulatory product record" }, "reviewedAt": "2026-09-09", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "甲钴胺是维生素 B12 的一种形式，口服产品用于周围神经病。先认清单位：500 μg 等于 0.5 mg，不是 500 mg。药盒上的每片含量，不等于医生为你安排的一次用量。", "history": "日本标签记载 500 μg 片于 1981 年 9 月开始销售。卫材 2018 年的苏州工厂公告将弥可保列为中国口服固体制剂产品，并另行介绍注射剂生产。这是剂型与生产历史线索，不是今日库存或全球首次上市证明。", "sourceDocuments": [ { "id": "src_7c9713671b8dcd2b", "label": "PMDA: Methycobal tablets 250 / 500 micrograms and fine granules; April 2023 label", "url": "https://www.pmda.go.jp/PmdaSearch/iyakuDetail/ResultDataSetPDF/170033_3136004C1038_1_05", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-09", "reviewedAt": "2026-09-09" }, { "id": "src_839ae851935d166d", "label": "PMDA: Methycobal patient guide, May 2026", "url": "https://www.info.pmda.go.jp/downfiles/ph/GUI/170033_3136004C1038_1_00GW/170033_3136004C1038_1_00GW.htm", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "patient_medication_guide", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-09", "reviewedAt": "2026-09-09" }, { "id": "src_a992c72834568e24", "label": "Singapore National Drug Formulary: METHYCOBAL TABLET 500 MCG, SIN06291P; updated 28 July 2026", "url": "https://www.ndf.gov.sg/about-drugs/product-information/sin06291p/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "regulatory_product_record", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-09", "reviewedAt": "2026-09-09" }, { "id": "src_d7b4630f312c3983", "label": "Eisai China: Suzhou oral solid-dose factory announcement, 11 January 2018; historical Methycobal brand evidence", "url": "https://www.eisai.com.cn/2018/01/11/%E5%8D%AB%E6%9D%90%E4%BD%8D%E4%BA%8E%E4%B8%AD%E5%9B%BD%E8%8B%8F%E5%B7%9E%E6%96%B0%E5%B7%A5%E5%8E%82%E7%9A%84%E5%8F%A3%E6%9C%8D%E5%9B%BA%E4%BD%93%E5%88%B6%E5%89%82%E5%8E%82%E6%88%BF%E7%AB%A3%E5%B7%A5/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "manufacturer_product_record", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-09", "reviewedAt": "2026-09-09" } ], "applicationNumber": "JP 15400AMZ01326000 / 15400AMZ01327000; SG SIN06291P", "approvalTimeline": [ { "date": "1981-09", "title": { "zh": "日本 500 μg 片开始销售", "en": "Japanese 500 microgram tablet sales began" }, "detail": { "zh": "日本标签记录的本规格销售日期，不是全球首发结论。", "en": "A product-specific Japanese sales date, not a global-first claim." }, "source": { "id": "src_7c9713671b8dcd2b", "label": "PMDA: Methycobal tablets 250 / 500 micrograms and fine granules; April 2023 label", "url": "https://www.pmda.go.jp/PmdaSearch/iyakuDetail/ResultDataSetPDF/170033_3136004C1038_1_05", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-09", "reviewedAt": "2026-09-09" } }, { "date": "2018-01-11", "title": { "zh": "中国口服固体制剂生产历史", "en": "Oral solid-dose manufacturing history in China" }, "detail": { "zh": "卫材公告介绍苏州新厂规划，并将弥可保口服产品与注射剂生产分开介绍；历史计划不改写为今天的实际产量。", "en": "Eisai’s announcement described Suzhou factory plans and separated oral products from injection manufacturing. Historical plans are not presented as today’s output." }, "source": { "id": "src_d7b4630f312c3983", "label": "Eisai China: Suzhou oral solid-dose factory announcement, 11 January 2018; historical Methycobal brand evidence", "url": "https://www.eisai.com.cn/2018/01/11/%E5%8D%AB%E6%9D%90%E4%BD%8D%E4%BA%8E%E4%B8%AD%E5%9B%BD%E8%8B%8F%E5%B7%9E%E6%96%B0%E5%B7%A5%E5%8E%82%E7%9A%84%E5%8F%A3%E6%9C%8D%E5%9B%BA%E4%BD%93%E5%88%B6%E5%89%82%E5%8E%82%E6%88%BF%E7%AB%A3%E5%B7%A5/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "manufacturer_product_record", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-09", "reviewedAt": "2026-09-09" } } ], "marketStatus": [ { "market": { "zh": "中国大陆", "en": "Mainland China" }, "status": { "zh": "历史品牌线索；现行说明书未核实", "en": "Historical brand clue; current leaflet not verified" }, "detail": { "zh": "尚未取得中国现行官方说明书和独立 NMPA 记录，不填入未经核实的批准编号、包装、价格或库存。", "en": "A current Chinese official leaflet and independent NMPA record have not been verified. Approval IDs, packs, prices and inventory are not invented." } }, { "market": { "zh": "日本", "en": "Japan" }, "status": { "zh": "PMDA 公开原件已核对", "en": "Public PMDA originals checked" }, "detail": { "zh": "本页两项 100 片包装仅作日本产品身份示例，不表示列齐所有包装或实时供应。", "en": "The two 100-tablet presentations are Japanese identity examples, not all pack sizes or live supply." } }, { "market": { "zh": "新加坡", "en": "Singapore" }, "status": { "zh": "政府产品记录已核对", "en": "Government product record checked" }, "detail": { "zh": "SIN06291P 对应 500 MCG 糖衣片；登记分类不移植到其他国家，也不等于本站提供销售。", "en": "SIN06291P identifies a 500 MCG sugar-coated tablet. Its local classification does not transfer to other countries or mean this site sells it." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "500 μg 比 0.5 mg 多吗？", "en": "Is 500 μg more than 0.5 mg?" }, "answer": { "zh": "不多，两者是同一个含量的不同写法。500 mg 则是 0.5 mg 的一千倍；核对时把数字和单位一起读给药师听。", "en": "No: these express the same amount. 500 mg is a thousand times 0.5 mg; read the number and unit together when checking with your pharmacist." } }, { "question": { "zh": "维生素类药就能随便加吗？", "en": "Can I freely add a vitamin medicine?" }, "answer": { "zh": "不要仅凭这个名称自行加量或叠加。先核对所有药品及营养补充剂的成分，并说清楚症状和已使用多久。", "en": "Do not add or increase treatment merely because it is a vitamin. Review all medicine and supplement ingredients, symptoms and duration of use." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "dose-unit-literacy", "interactions-are-not-a-home-scheduling-problem" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/methycobal-mecobalamin/", "en": "https://origindrug.com/en/drugs/methycobal-mecobalamin/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "duphalac-lactulose", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-09-09", "status": "published_traceable_archive" }, "names": { "brand": "Duphalac", "generic": "乳果糖", "aliases": [ "杜密克", "杜密克®", "乳果糖口服溶液", "lactulose", "Duphalac", "乳果糖" ], "marketBrandNames": [ { "name": "杜密克® / Duphalac®", "market": { "zh": "中国大陆", "en": "Mainland China" }, "evidenceStatus": "dated_public_record", "note": { "zh": "袋装 OTC 原件；不是所有乳果糖产品的通用说明书。", "en": "Sachet OTC original, not a universal lactulose leaflet." }, "source": { "id": "src_ef32e8bef5ca9032", "label": "Abbott China: Duphalac sachet OTC leaflet, revised 2025-05-21", "url": "https://www.abbott.com.cn/content/dam/corp/abbott/cn-cn/2026_update/%E4%B9%B3%E6%9E%9C%E7%B3%96%E5%8F%A3%E6%9C%8D%E6%BA%B6%E6%B6%B2%EF%BC%88%E8%A2%8B%E8%A3%85%EF%BC%89OTC%20%E8%AF%B4%E6%98%8E%E4%B9%A6_20250521.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "first_party_leaflet", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-09", "reviewedAt": "2026-09-09" } }, { "name": "Duphalac", "market": { "zh": "新加坡", "en": "Singapore" }, "evidenceStatus": "dated_public_record", "note": { "zh": "NDF 记录为 67 g/100 mL；保留当地标示口径。", "en": "NDF records 67 g/100 mL; local notation is preserved." }, "source": { "id": "src_c61a51c19f35ff25", "label": "Singapore NDF: DUPHALAC SYRUP, SIN02818P; updated 2026-07-28", "url": "https://www.ndf.gov.sg/about-drugs/product-information/sin02818p/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "regulatory_product_record", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-09", "reviewedAt": "2026-09-09" } } ], "mainlandChinaTradeNameCue": { "value": "杜密克®", "status": "discovery_cue_requires_target_market_verification", "source": { "id": "src_ef32e8bef5ca9032", "label": "Abbott China: Duphalac sachet OTC leaflet, revised 2025-05-21", "url": "https://www.abbott.com.cn/content/dam/corp/abbott/cn-cn/2026_update/%E4%B9%B3%E6%9E%9C%E7%B3%96%E5%8F%A3%E6%9C%8D%E6%BA%B6%E6%B6%B2%EF%BC%88%E8%A2%8B%E8%A3%85%EF%BC%89OTC%20%E8%AF%B4%E6%98%8E%E4%B9%A6_20250521.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "first_party_leaflet", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-09", "reviewedAt": "2026-09-09" } } }, "identity": { "therapeuticArea": "消化系统", "sourceArchiveMarket": "中国杜密克袋装处方与非处方原件；英国、新加坡记录分列，不互套用法。", "dosageFormClass": "口服液体制剂", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "1988（英国批准记录）", "archiveSponsorText": "Abbott B.V. / Mylan Products Ltd. (market-specific)" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [ "杜密克", "乳果糖", "lactulose", "Duphalac" ], "excludedProductCues": [ "diosmectite", "蒙脱石", "polyethylene glycol", "聚乙二醇" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "cn-duphalac-otc-15ml-6-sachets", "marketCode": "CN", "labelVersion": { "zh": "袋装 OTC 原件，2025-05-21 修订", "en": "Sachet OTC original, revised 21 May 2025" }, "dosageForm": { "zh": "乳果糖口服溶液", "en": "Lactulose oral solution" }, "route": { "zh": "口服", "en": "Oral" }, "routeCodes": [ "oral" ], "productCode": "HJ20171057", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_mL", "primaryDisplay": { "zh": "667 mg/mL；15 mL/袋；6 袋/盒", "en": "667 mg/mL; 15 mL/sachet; 6 sachets/carton" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "乳果糖", "en": "lactulose" }, "value": 667, "unit": "mg", "basisCode": "per_mL", "basisLabel": { "zh": "每毫升含量，不是一次用量", "en": "Per mL, not a personal dose" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-09", "currentLabelDisplayed": false, "ndcDirectoryListed": false, "marketAvailability": "label_listed_not_live_supply", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 6, "unit": { "zh": "袋/盒", "en": "sachets/carton" } }, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_ef32e8bef5ca9032", "label": "Abbott China: Duphalac sachet OTC leaflet, revised 2025-05-21", "url": "https://www.abbott.com.cn/content/dam/corp/abbott/cn-cn/2026_update/%E4%B9%B3%E6%9E%9C%E7%B3%96%E5%8F%A3%E6%9C%8D%E6%BA%B6%E6%B6%B2%EF%BC%88%E8%A2%8B%E8%A3%85%EF%BC%89OTC%20%E8%AF%B4%E6%98%8E%E4%B9%A6_20250521.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "first_party_leaflet", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-09", "reviewedAt": "2026-09-09" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "cn-duphalac-otc-15ml-10-sachets", "marketCode": "CN", "labelVersion": { "zh": "袋装 OTC 原件，2025-05-21 修订", "en": "Sachet OTC original, revised 21 May 2025" }, "dosageForm": { "zh": "乳果糖口服溶液", "en": "Lactulose oral solution" }, "route": { "zh": "口服", "en": "Oral" }, "routeCodes": [ "oral" ], "productCode": "HJ20171057", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_mL", "primaryDisplay": { "zh": "667 mg/mL；15 mL/袋；10 袋/盒", "en": "667 mg/mL; 15 mL/sachet; 10 sachets/carton" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "乳果糖", "en": "lactulose" }, "value": 667, "unit": "mg", "basisCode": "per_mL", "basisLabel": { "zh": "每毫升含量，不是一次用量", "en": "Per mL, not a personal dose" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-09", "currentLabelDisplayed": false, "ndcDirectoryListed": false, "marketAvailability": "label_listed_not_live_supply", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 10, "unit": { "zh": "袋/盒", "en": "sachets/carton" } }, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_ef32e8bef5ca9032", "label": "Abbott China: Duphalac sachet OTC leaflet, revised 2025-05-21", "url": "https://www.abbott.com.cn/content/dam/corp/abbott/cn-cn/2026_update/%E4%B9%B3%E6%9E%9C%E7%B3%96%E5%8F%A3%E6%9C%8D%E6%BA%B6%E6%B6%B2%EF%BC%88%E8%A2%8B%E8%A3%85%EF%BC%89OTC%20%E8%AF%B4%E6%98%8E%E4%B9%A6_20250521.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "first_party_leaflet", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-09", "reviewedAt": "2026-09-09" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "cn-duphalac-otc-15ml-20-sachets", "marketCode": "CN", "labelVersion": { "zh": "袋装 OTC 原件，2025-05-21 修订", "en": "Sachet OTC original, revised 21 May 2025" }, "dosageForm": { "zh": "乳果糖口服溶液", "en": "Lactulose oral solution" }, "route": { "zh": "口服", "en": "Oral" }, "routeCodes": [ "oral" ], "productCode": "HJ20171057", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_mL", "primaryDisplay": { "zh": "667 mg/mL；15 mL/袋；20 袋/盒", "en": "667 mg/mL; 15 mL/sachet; 20 sachets/carton" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "乳果糖", "en": "lactulose" }, "value": 667, "unit": "mg", "basisCode": "per_mL", "basisLabel": { "zh": "每毫升含量，不是一次用量", "en": "Per mL, not a personal dose" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-09", "currentLabelDisplayed": false, "ndcDirectoryListed": false, "marketAvailability": "label_listed_not_live_supply", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 20, "unit": { "zh": "袋/盒", "en": "sachets/carton" } }, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_ef32e8bef5ca9032", "label": "Abbott China: Duphalac sachet OTC leaflet, revised 2025-05-21", "url": "https://www.abbott.com.cn/content/dam/corp/abbott/cn-cn/2026_update/%E4%B9%B3%E6%9E%9C%E7%B3%96%E5%8F%A3%E6%9C%8D%E6%BA%B6%E6%B6%B2%EF%BC%88%E8%A2%8B%E8%A3%85%EF%BC%89OTC%20%E8%AF%B4%E6%98%8E%E4%B9%A6_20250521.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "first_party_leaflet", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-09", "reviewedAt": "2026-09-09" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "status": "withheld_repackaged_or_non_exact_visual", "title": { "zh": "先核文字身份，暂不展示外盒照片", "en": "Check text identity; exact carton photo not shown" }, "summary": { "zh": "尚未取得与这三个中国 OTC 包装逐一对应的官方外盒图。包装卡不证明真伪或现货。", "en": "No official carton images matched individually to these three Chinese OTC packs were obtained. Cards establish neither authenticity nor stock." }, "source": { "id": "src_ef32e8bef5ca9032", "label": "Abbott China: Duphalac sachet OTC leaflet, revised 2025-05-21", "url": "https://www.abbott.com.cn/content/dam/corp/abbott/cn-cn/2026_update/%E4%B9%B3%E6%9E%9C%E7%B3%96%E5%8F%A3%E6%9C%8D%E6%BA%B6%E6%B6%B2%EF%BC%88%E8%A2%8B%E8%A3%85%EF%BC%89OTC%20%E8%AF%B4%E6%98%8E%E4%B9%A6_20250521.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "first_party_leaflet", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-09", "reviewedAt": "2026-09-09" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "大字读说明书：先分清 OTC 与处方版", "en": "Large-print reading: distinguish OTC and prescription versions" }, "summary": { "zh": "本段阅读中国袋装 OTC 原件：用于慢性功能性便秘。袋数不是用量；老人及有其他疾病者应由医生指导使用。", "en": "This reads the Chinese sachet OTC original for chronic functional constipation. Pack count is not a dose; older adults and people with other conditions need medical guidance." }, "checks": [ { "zh": "667 mg/mL 是浓度；15 mL 是一袋体积。原件另写“15 mL：10 g”，保留标签的取整口径，不拿袋数决定一次喝多少。", "en": "667 mg/mL is concentration; 15 mL is sachet volume. The leaflet also states 15 mL:10 g using its rounded notation." }, { "zh": "不明原因腹痛、肠梗阻或急性炎症性肠病等属于原件禁忌；先就医查原因。", "en": "Unexplained abdominal pain, obstruction and acute inflammatory bowel disease are among the contraindications; seek assessment first." }, { "zh": "腹泻会造成水分和电解质丢失。老人长期使用需核对监测；同时有利尿药、强心苷等，应带完整药单问药师。", "en": "Diarrhoea can disturb fluid and electrolytes. Older long-term users need monitoring review; bring a complete list, including diuretics or cardiac glycosides." }, { "zh": "若治疗二三天后便秘没有改善或反复出现，咨询医生；儿童、妊娠及哺乳期须另核原件限制。", "en": "Consult a clinician if constipation persists or recurs after two or three days; separately check paediatric, pregnancy and breastfeeding restrictions." } ], "source": { "id": "src_ef32e8bef5ca9032", "label": "Abbott China: Duphalac sachet OTC leaflet, revised 2025-05-21", "url": "https://www.abbott.com.cn/content/dam/corp/abbott/cn-cn/2026_update/%E4%B9%B3%E6%9E%9C%E7%B3%96%E5%8F%A3%E6%9C%8D%E6%BA%B6%E6%B6%B2%EF%BC%88%E8%A2%8B%E8%A3%85%EF%BC%89OTC%20%E8%AF%B4%E6%98%8E%E4%B9%A6_20250521.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "first_party_leaflet", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-09", "reviewedAt": "2026-09-09" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "帮助肠道保留水分，让大便变软", "en": "Helps retain water in the bowel and soften stool" }, "summary": { "zh": "肠道细菌把乳果糖分解成有机酸，改变肠内环境，并通过渗透作用增加水分、促进排便。", "en": "Bowel bacteria break lactulose into organic acids; the resulting osmotic effect increases water in the bowel and supports bowel movement." }, "checks": [ { "zh": "它不是即刻见效的“清肠水”；英国说明书提示可能需二三天起效，各市场原件应分开读。", "en": "It is not an instant bowel cleanse. The UK label notes that an effect may take two or three days; keep local instructions separate." }, { "zh": "肝性脑病也是处方原件中的用途，但与便秘的治疗目标不同，不能抄用另一用途的剂量。", "en": "Hepatic encephalopathy is a prescription indication with different treatment goals; do not copy its dose for constipation." }, { "zh": "吸收很少不等于没有副作用；腹胀、腹痛、腹泻及电解质问题仍需留意。", "en": "Low absorption does not mean no adverse effects: bloating, pain, diarrhoea and electrolyte problems still matter." } ], "source": { "id": "src_7598b6ea3f635a2e", "label": "UK emc: Duphalac SmPC, PL 46302/0032; text revised April 2022", "url": "https://www.medicines.org.uk/emc/product/5525/smpc", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-09", "reviewedAt": "2026-09-09" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "Duphalac", "generic": "乳果糖", "dosageFormClass": "口服液体制剂" }, "labelSource": { "id": "src_ef32e8bef5ca9032", "label": "Abbott China: Duphalac sachet OTC leaflet, revised 2025-05-21", "url": "https://www.abbott.com.cn/content/dam/corp/abbott/cn-cn/2026_update/%E4%B9%B3%E6%9E%9C%E7%B3%96%E5%8F%A3%E6%9C%8D%E6%BA%B6%E6%B6%B2%EF%BC%88%E8%A2%8B%E8%A3%85%EF%BC%89OTC%20%E8%AF%B4%E6%98%8E%E4%B9%A6_20250521.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "first_party_leaflet", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-09", "reviewedAt": "2026-09-09" }, "productRoutes": [ { "source": { "id": "src_ef32e8bef5ca9032", "label": "Abbott China: Duphalac sachet OTC leaflet, revised 2025-05-21", "url": "https://www.abbott.com.cn/content/dam/corp/abbott/cn-cn/2026_update/%E4%B9%B3%E6%9E%9C%E7%B3%96%E5%8F%A3%E6%9C%8D%E6%BA%B6%E6%B6%B2%EF%BC%88%E8%A2%8B%E8%A3%85%EF%BC%89OTC%20%E8%AF%B4%E6%98%8E%E4%B9%A6_20250521.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "first_party_leaflet", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-09", "reviewedAt": "2026-09-09" }, "status": "manufacturer_public_label_verified", "authority": { "zh": "雅培中国", "en": "Abbott China" }, "market": { "zh": "中国大陆", "en": "Mainland China" }, "recordType": { "zh": "企业公开说明书", "en": "Manufacturer public leaflet" }, "reviewedAt": "2026-09-09", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_d09b4df491f3fd70", "label": "Abbott China: Duphalac sachet prescription leaflet, revised 2025-05-21", "url": "https://www.abbott.com.cn/content/dam/corp/abbott/cn-cn/2026_update/%E4%B9%B3%E6%9E%9C%E7%B3%96%E5%8F%A3%E6%9C%8D%E6%BA%B6%E6%B6%B2%EF%BC%88%E8%A2%8B%E8%A3%85%EF%BC%89Rx%20%E8%AF%B4%E6%98%8E%E4%B9%A6_20250521.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "first_party_leaflet", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-09", "reviewedAt": "2026-09-09" }, "status": "manufacturer_public_label_verified", "authority": { "zh": "雅培中国", "en": "Abbott China" }, "market": { "zh": "中国大陆", "en": "Mainland China" }, "recordType": { "zh": "企业公开说明书", "en": "Manufacturer public leaflet" }, "reviewedAt": "2026-09-09", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_7598b6ea3f635a2e", "label": "UK emc: Duphalac SmPC, PL 46302/0032; text revised April 2022", "url": "https://www.medicines.org.uk/emc/product/5525/smpc", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-09", "reviewedAt": "2026-09-09" }, "status": "product_level_public_record_verified", "authority": { "zh": "英国电子药品目录 eMC", "en": "UK electronic medicines compendium (emc)" }, "market": { "zh": "英国", "en": "United Kingdom" }, "recordType": { "zh": "公开药品说明书或患者说明书", "en": "Public product information or patient leaflet" }, "reviewedAt": "2026-09-09", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_c61a51c19f35ff25", "label": "Singapore NDF: DUPHALAC SYRUP, SIN02818P; updated 2026-07-28", "url": "https://www.ndf.gov.sg/about-drugs/product-information/sin02818p/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "regulatory_product_record", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-09", "reviewedAt": "2026-09-09" }, "status": "product_level_public_record_verified", "authority": { "zh": "新加坡国家药物目录 NDF", "en": "Singapore National Drug Formulary (NDF)" }, "market": { "zh": "新加坡", "en": "Singapore" }, "recordType": { "zh": "政府药物目录产品资料与说明书节选", "en": "Government drug formulary product information and leaflet excerpts" }, "reviewedAt": "2026-09-09", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "manufacturer_public_label_verified", "authority": { "zh": "雅培中国", "en": "Abbott China" }, "market": { "zh": "中国大陆", "en": "Mainland China" }, "recordType": { "zh": "企业公开说明书", "en": "Manufacturer public leaflet" }, "reviewedAt": "2026-09-09", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "杜密克的成分是乳果糖，用于帮助缓解便秘。667 mg/mL 表示每毫升的成分含量，15 mL 是一袋液体的体积。先确认手里是哪个市场、处方版还是非处方版，再核对医生或药师给你的用法。", "history": "英国所列首次批准日期为 1988-03-14，不是全球首发结论。中国雅培袋装处方与非处方文件均标注 2025-05-21 修订；新加坡另以 SIN02818P 登记。", "sourceDocuments": [ { "id": "src_ef32e8bef5ca9032", "label": "Abbott China: Duphalac sachet OTC leaflet, revised 2025-05-21", "url": "https://www.abbott.com.cn/content/dam/corp/abbott/cn-cn/2026_update/%E4%B9%B3%E6%9E%9C%E7%B3%96%E5%8F%A3%E6%9C%8D%E6%BA%B6%E6%B6%B2%EF%BC%88%E8%A2%8B%E8%A3%85%EF%BC%89OTC%20%E8%AF%B4%E6%98%8E%E4%B9%A6_20250521.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "first_party_leaflet", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-09", "reviewedAt": "2026-09-09" }, { "id": "src_d09b4df491f3fd70", "label": "Abbott China: Duphalac sachet prescription leaflet, revised 2025-05-21", "url": "https://www.abbott.com.cn/content/dam/corp/abbott/cn-cn/2026_update/%E4%B9%B3%E6%9E%9C%E7%B3%96%E5%8F%A3%E6%9C%8D%E6%BA%B6%E6%B6%B2%EF%BC%88%E8%A2%8B%E8%A3%85%EF%BC%89Rx%20%E8%AF%B4%E6%98%8E%E4%B9%A6_20250521.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "first_party_leaflet", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-09", "reviewedAt": "2026-09-09" }, { "id": "src_7598b6ea3f635a2e", "label": "UK emc: Duphalac SmPC, PL 46302/0032; text revised April 2022", "url": "https://www.medicines.org.uk/emc/product/5525/smpc", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-09", "reviewedAt": "2026-09-09" }, { "id": "src_c61a51c19f35ff25", "label": "Singapore NDF: DUPHALAC SYRUP, SIN02818P; updated 2026-07-28", "url": "https://www.ndf.gov.sg/about-drugs/product-information/sin02818p/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "regulatory_product_record", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-09", "reviewedAt": "2026-09-09" } ], "applicationNumber": "CN HJ20171057; UK PL 46302/0032; SG SIN02818P", "approvalTimeline": [ { "date": "1988-03-14", "title": { "zh": "英国所列首次批准", "en": "First authorisation listed in the UK" }, "detail": { "zh": "仅对应英国原件的本市场日期。", "en": "Market-specific date in the UK original." }, "source": { "id": "src_7598b6ea3f635a2e", "label": "UK emc: Duphalac SmPC, PL 46302/0032; text revised April 2022", "url": "https://www.medicines.org.uk/emc/product/5525/smpc", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-09", "reviewedAt": "2026-09-09" } }, { "date": "2025-05-21", "title": { "zh": "中国说明书修订", "en": "Chinese leaflets revised" }, "detail": { "zh": "袋装 OTC 与处方文件分别保留。", "en": "Sachet OTC and prescription documents remain separate." }, "source": { "id": "src_d09b4df491f3fd70", "label": "Abbott China: Duphalac sachet prescription leaflet, revised 2025-05-21", "url": "https://www.abbott.com.cn/content/dam/corp/abbott/cn-cn/2026_update/%E4%B9%B3%E6%9E%9C%E7%B3%96%E5%8F%A3%E6%9C%8D%E6%BA%B6%E6%B6%B2%EF%BC%88%E8%A2%8B%E8%A3%85%EF%BC%89Rx%20%E8%AF%B4%E6%98%8E%E4%B9%A6_20250521.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "first_party_leaflet", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-09", "reviewedAt": "2026-09-09" } } ], "marketStatus": [ { "market": { "zh": "中国大陆", "en": "Mainland China" }, "status": { "zh": "企业公开原件已核对", "en": "First-party originals checked" }, "detail": { "zh": "处方文件列便秘及肝性脑病用途，袋装包装列 6 袋；OTC 另列 6/10/20 袋。本页包装卡只引用 OTC；未独立核验 NMPA 当前记录。", "en": "The prescription document covers constipation and hepatic encephalopathy and lists a six-sachet carton. OTC lists 6/10/20. Pack cards cite OTC only; a separate current NMPA check is not completed." } }, { "market": { "zh": "新加坡", "en": "Singapore" }, "status": { "zh": "政府 NDF 产品记录已核对", "en": "Government NDF product record checked" }, "detail": { "zh": "SIN02818P，持有人 Abbott Laboratories (Singapore) Private Limited，制造商 Abbott Biologicals B.V.；不等于中国包装或实时库存。", "en": "SIN02818P: holder Abbott Laboratories (Singapore) Private Limited; manufacturer Abbott Biologicals B.V. This is not Chinese packaging or live stock." } }, { "market": { "zh": "英国", "en": "United Kingdom" }, "status": { "zh": "eMC 原件已核对", "en": "emc original checked" }, "detail": { "zh": "原件正文修订日期是 2022 年 4 月；本次访问日期不是新修订日期。", "en": "The text revision is April 2022; this access check is not a new label revision." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "不含辅料，就是无糖吗？", "en": "Does no excipients mean sugar-free?" }, "answer": { "zh": "不是。处方原件同时写有生产过程带入的半乳糖、乳糖及亚硫酸盐相关提示；糖不耐受、糖尿病或过敏应按具体原件咨询。", "en": "No. The prescription original also discusses galactose, lactose and sulphite associated with manufacturing. Review sugar intolerance, diabetes or allergy against the exact original." } }, { "question": { "zh": "两种说明书能挑方便的那份用吗？", "en": "Can I choose whichever leaflet is more convenient?" }, "answer": { "zh": "不能。用准确药盒和处方核对用途、版本、计量工具及个人用法；不要混合处方版、OTC 或国外方案。", "en": "No. Match your pack and prescription to the indication, version, measuring device and individual instructions rather than mixing versions or countries." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "dose-unit-literacy", "medicine-label-for-everyday-questions", "interactions-are-not-a-home-scheduling-problem" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/duphalac-lactulose/", "en": "https://origindrug.com/en/drugs/duphalac-lactulose/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "smecta-diosmectite", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-09-09", "status": "published_traceable_archive" }, "names": { "brand": "Smecta", "generic": "蒙脱石", "aliases": [ "蒙脱石散", "diosmectite", "dioctahedral smectite", "Smecta", "蒙脱石" ], "marketBrandNames": [ { "name": "SMECTA ORANGE-VANILLE", "market": { "zh": "法国", "en": "France" }, "evidenceStatus": "dated_public_record", "note": { "zh": "本页包装卡仅对应橙香草味粉末。", "en": "Pack card covers orange-vanilla powder only." }, "source": { "id": "src_43e3f8c84a63767c", "label": "France public medicines database / ANSM: SMECTA 3 g ORANGE-VANILLE, CIS 69584073; label page updated 2025-04-22", "url": "https://base-donnees-publique.medicaments.gouv.fr/medicament/69584073/extrait", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "FR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-09", "reviewedAt": "2026-09-09" } }, { "name": "SMECTA SACHET", "market": { "zh": "新加坡", "en": "Singapore" }, "evidenceStatus": "dated_public_record", "note": { "zh": "SIN06338P，3 g/袋。", "en": "SIN06338P, 3 g/sachet." }, "source": { "id": "src_8acbc7d2835c293e", "label": "Singapore NDF: SMECTA SACHET 3 G/SACHET, SIN06338P; updated 2026-07-28", "url": "https://www.ndf.gov.sg/about-drugs/product-information/sin06338p/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "regulatory_product_record", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-09", "reviewedAt": "2026-09-09" } } ], "mainlandChinaTradeNameCue": { "value": "思密达®", "status": "discovery_cue_requires_target_market_verification", "source": { "id": "src_01bfc95f19ef84c3", "label": "济宁市人民政府：2024 年基层医疗机构药品信息中的思密达／蒙脱石散 3 g 记录", "url": "https://www.jining.gov.cn/art/2024/5/21/art_93211_2803357.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "government_medicine_listing", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-12", "reviewedAt": "2026-09-12" } } }, "identity": { "therapeuticArea": "消化系统", "sourceArchiveMarket": "法国 Smecta 橙香草味粉末与新加坡记录；中国商品名、批准及包装尚待独立核验。", "dosageFormClass": "口服固体制剂", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "1988（法国批准记录）", "archiveSponsorText": "Mayoly Pharma France" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [ "蒙脱石", "蒙脱石散", "Smecta", "diosmectite" ], "excludedProductCues": [ "lactulose", "乳果糖", "loperamide", "洛哌丁胺" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "fr-smecta-orange-vanilla-3g-30-sachets", "marketCode": "FR", "labelVersion": { "zh": "ANSM 页面标注更新 2025-04-22", "en": "ANSM page marked updated 22 April 2025" }, "dosageForm": { "zh": "冲配为口服混悬液的粉末", "en": "Powder for oral suspension" }, "route": { "zh": "口服", "en": "Oral" }, "routeCodes": [ "oral" ], "productCode": "3400931923077", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_packet", "primaryDisplay": { "zh": "每袋蒙脱石 3 g；整袋粉末 3.760 g；30 袋/盒", "en": "3 g diosmectite per sachet; 3.760 g total powder; 30 sachets/carton" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "蒙脱石", "en": "diosmectite" }, "value": 3, "unit": "g", "basisCode": "per_packet", "basisLabel": { "zh": "每袋成分含量", "en": "Active amount per sachet" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-09", "currentLabelDisplayed": false, "ndcDirectoryListed": false, "marketAvailability": "label_listed_not_live_supply", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 30, "unit": { "zh": "袋/盒", "en": "sachets/carton" } }, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_43e3f8c84a63767c", "label": "France public medicines database / ANSM: SMECTA 3 g ORANGE-VANILLE, CIS 69584073; label page updated 2025-04-22", "url": "https://base-donnees-publique.medicaments.gouv.fr/medicament/69584073/extrait", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "FR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-09", "reviewedAt": "2026-09-09" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "status": "withheld_repackaged_or_non_exact_visual", "title": { "zh": "暂缺这一准确包装的官方照片", "en": "Exact official pack photograph not available" }, "summary": { "zh": "不以其他国家、口味或电商外盒代替；文字卡也不能鉴定真伪。", "en": "No other country, flavour or retail carton is substituted; text identity cannot authenticate a pack." }, "source": { "id": "src_43e3f8c84a63767c", "label": "France public medicines database / ANSM: SMECTA 3 g ORANGE-VANILLE, CIS 69584073; label page updated 2025-04-22", "url": "https://base-donnees-publique.medicaments.gouv.fr/medicament/69584073/extrait", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "FR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-09", "reviewedAt": "2026-09-09" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "大字读法国说明书：先看补液与同服药", "en": "Large-print French leaflet: rehydration and other medicines" }, "summary": { "zh": "阅读对象是法国橙香草味粉末，不是中国通用用法。", "en": "This reads French orange-vanilla powder, not Chinese instructions." }, "checks": [ { "zh": "3 g 为成分，3.760 g 包含辅料；30 袋是包装数量。", "en": "3 g is active ingredient; 3.760 g includes excipients; 30 is pack count." }, { "zh": "法国原件不用于 2 岁以下儿童，妊娠和哺乳期不推荐；严重便秘史先咨询。", "en": "The French leaflet excludes under-twos, discourages pregnancy/breastfeeding use and calls for caution with severe constipation history." }, { "zh": "可能影响其他口服药吸收；法国原件建议尽可能间隔超过 2 小时。完整药单仍需药师核对，不是“错开就都安全”。", "en": "It may affect other oral medicines; France advises over two hours apart where possible. A pharmacist must still review the whole list." }, { "zh": "腹泻三天无改善或恶化、腹痛伴发热或呕吐，应就医；呼吸困难或喉面肿胀立即急救。", "en": "Seek care for diarrhoea not improving after three days or pain with fever/vomiting; breathing difficulty or face/throat swelling needs emergency help." } ], "source": { "id": "src_43e3f8c84a63767c", "label": "France public medicines database / ANSM: SMECTA 3 g ORANGE-VANILLE, CIS 69584073; label page updated 2025-04-22", "url": "https://base-donnees-publique.medicaments.gouv.fr/medicament/69584073/extrait", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "FR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-09", "reviewedAt": "2026-09-09" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "在肠内覆盖、吸附；补液仍是另一件事", "en": "Acts within the bowel; rehydration is separate" }, "summary": { "zh": "蒙脱石在肠腔中发挥覆盖和吸附作用；减少腹泻症状不等于补回丢失的水分和电解质。", "en": "Diosmectite covers and adsorbs within the bowel; symptom relief does not replace lost water and electrolytes." }, "checks": [ { "zh": "法国原件明确：使用 Smecta 并不能省略必要的补液。", "en": "The French original states that Smecta does not remove the need for appropriate rehydration." }, { "zh": "补液方式需结合腹泻严重程度、年龄和个人状况决定；不要只看“止泻了没有”。", "en": "Rehydration depends on severity, age and clinical context, not only whether diarrhoea slows." }, { "zh": "这款粉末需要临用前冲配成混悬液；先核对具体剂型和你手里的本地说明书。", "en": "This powder must be mixed into a suspension just before use; check the exact form and your local leaflet." } ], "source": { "id": "src_43e3f8c84a63767c", "label": "France public medicines database / ANSM: SMECTA 3 g ORANGE-VANILLE, CIS 69584073; label page updated 2025-04-22", "url": "https://base-donnees-publique.medicaments.gouv.fr/medicament/69584073/extrait", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "FR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-09", "reviewedAt": "2026-09-09" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "Smecta", "generic": "蒙脱石", "dosageFormClass": "口服固体制剂" }, "labelSource": { "id": "src_43e3f8c84a63767c", "label": "France public medicines database / ANSM: SMECTA 3 g ORANGE-VANILLE, CIS 69584073; label page updated 2025-04-22", "url": "https://base-donnees-publique.medicaments.gouv.fr/medicament/69584073/extrait", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "FR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-09", "reviewedAt": "2026-09-09" }, "productRoutes": [ { "source": { "id": "src_43e3f8c84a63767c", "label": "France public medicines database / ANSM: SMECTA 3 g ORANGE-VANILLE, CIS 69584073; label page updated 2025-04-22", "url": "https://base-donnees-publique.medicaments.gouv.fr/medicament/69584073/extrait", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "FR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-09", "reviewedAt": "2026-09-09" }, "status": "product_level_public_record_verified", "authority": { "zh": "法国药监 ANSM", "en": "ANSM" }, "market": { "zh": "法国", "en": "France" }, "recordType": { "zh": "政府药品数据库与公开说明书", "en": "Government medicines database and public leaflet" }, "reviewedAt": "2026-09-09", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_8acbc7d2835c293e", "label": "Singapore NDF: SMECTA SACHET 3 G/SACHET, SIN06338P; updated 2026-07-28", "url": "https://www.ndf.gov.sg/about-drugs/product-information/sin06338p/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "regulatory_product_record", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-09", "reviewedAt": "2026-09-09" }, "status": "product_level_public_record_verified", "authority": { "zh": "新加坡国家药物目录 NDF", "en": "Singapore National Drug Formulary (NDF)" }, "market": { "zh": "新加坡", "en": "Singapore" }, "recordType": { "zh": "政府药物目录产品资料与说明书节选", "en": "Government drug formulary product information and leaflet excerpts" }, "reviewedAt": "2026-09-09", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "法国药监 ANSM", "en": "ANSM" }, "market": { "zh": "法国", "en": "France" }, "recordType": { "zh": "政府药品数据库与公开说明书", "en": "Government medicines database and public leaflet" }, "reviewedAt": "2026-09-09", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "Smecta 的成分是蒙脱石，属于用于腹泻等症状的肠道吸附剂。它不能代替补液。药盒上的 3 g 是成分含量，不代表每个人一次都该吃一袋；老人同时服多种药时尤其要核对相互影响。", "history": "法国页面列本产品批准日期 1988-11-25。Mayoly 企业历史记载，2022 年收购益普生家庭健康业务，Smecta 是相关产品组合之一；这段企业沿革不证明全球首发日期。", "sourceDocuments": [ { "id": "src_43e3f8c84a63767c", "label": "France public medicines database / ANSM: SMECTA 3 g ORANGE-VANILLE, CIS 69584073; label page updated 2025-04-22", "url": "https://base-donnees-publique.medicaments.gouv.fr/medicament/69584073/extrait", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "FR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-09", "reviewedAt": "2026-09-09" }, { "id": "src_8acbc7d2835c293e", "label": "Singapore NDF: SMECTA SACHET 3 G/SACHET, SIN06338P; updated 2026-07-28", "url": "https://www.ndf.gov.sg/about-drugs/product-information/sin06338p/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "regulatory_product_record", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-09", "reviewedAt": "2026-09-09" }, { "id": "src_7960e5e5dc18f1a9", "label": "Mayoly: company history and 2022 acquisition of Ipsen family healthcare including Smecta", "url": "https://mayoly.com/en/about-us/who-we-are/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "manufacturer_history", "market": "FR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-09", "reviewedAt": "2026-09-09" } ], "applicationNumber": "FR CIS 69584073; CIP 3400931923077; SG SIN06338P", "approvalTimeline": [ { "date": "1988-11-25", "title": { "zh": "法国批准记录", "en": "French authorisation record" }, "detail": { "zh": "本产品的市场记录日期。", "en": "Market-specific product record date." }, "source": { "id": "src_43e3f8c84a63767c", "label": "France public medicines database / ANSM: SMECTA 3 g ORANGE-VANILLE, CIS 69584073; label page updated 2025-04-22", "url": "https://base-donnees-publique.medicaments.gouv.fr/medicament/69584073/extrait", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "FR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-09", "reviewedAt": "2026-09-09" } }, { "date": "2022", "title": { "zh": "Mayoly 收购相关业务", "en": "Mayoly acquired the relevant business" }, "detail": { "zh": "企业历史记载收购益普生家庭健康业务，组合包含 Smecta。", "en": "Company history records the Ipsen family-healthcare acquisition, with Smecta in the portfolio." }, "source": { "id": "src_7960e5e5dc18f1a9", "label": "Mayoly: company history and 2022 acquisition of Ipsen family healthcare including Smecta", "url": "https://mayoly.com/en/about-us/who-we-are/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "manufacturer_history", "market": "FR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-09", "reviewedAt": "2026-09-09" } } ], "marketStatus": [ { "market": { "zh": "法国", "en": "France" }, "status": { "zh": "政府产品原件已核对", "en": "Government product original checked" }, "detail": { "zh": "本页仅列 30 袋包装，不代表实时库存。", "en": "Only the 30-sachet pack is represented, not live stock." } }, { "market": { "zh": "新加坡", "en": "Singapore" }, "status": { "zh": "政府 NDF 产品记录已核对", "en": "Government NDF record checked" }, "detail": { "zh": "制造商 Mayoly Industrie（法国）；持有人 DKSH Singapore Pte. Ltd.，当地分类为 GSL。", "en": "Manufacturer Mayoly Industrie (France); holder DKSH Singapore Pte. Ltd.; local GSL classification." } }, { "market": { "zh": "中国大陆", "en": "Mainland China" }, "status": { "zh": "现行产品原件待核验", "en": "Current product original not verified" }, "detail": { "zh": "未把海外条目写成中国批准号、在售证明或包装。", "en": "Overseas records are not represented as Chinese authorisation, availability or packaging." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "国外有同名药，能直接照着吃吗？", "en": "Can I follow a same-brand foreign leaflet?" }, "answer": { "zh": "先核市场、完整品名、剂型和版本。新加坡记录只能说明该市场条目，不能替代你所在地区的说明书。", "en": "Check market, full name, form and version. Singapore’s entry identifies its local product and does not replace your local leaflet." } }, { "question": { "zh": "同样止泻，是同一种药吗？", "en": "Does a shared use mean the same medicine?" }, "answer": { "zh": "不是。先比对通用名，不要只按用途叠加或轮换；把实际药盒交给药师核对。", "en": "No. Compare generic names and have the actual packs checked rather than combining or alternating medicines by shared purpose." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "dose-unit-literacy", "medicine-label-for-everyday-questions", "interactions-are-not-a-home-scheduling-problem" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/smecta-diosmectite/", "en": "https://origindrug.com/en/drugs/smecta-diosmectite/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "forlax-macrogol-4000", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-09-09", "status": "published_traceable_archive" }, "names": { "brand": "Forlax", "generic": "聚乙二醇4000", "aliases": [ "福松", "聚乙二醇4000散", "macrogol 4000", "polyethylene glycol 4000", "Forlax", "聚乙二醇4000" ], "marketBrandNames": [ { "name": "FORLAX 10 g", "market": { "zh": "法国", "en": "France" }, "evidenceStatus": "dated_public_record", "note": { "zh": "法国参比组 736 指定的品牌产品。", "en": "Named reference product in French group 736." }, "source": { "id": "src_d1233b10aa106eac", "label": "France public medicines database: macrogol 4000 10 g reference group 736; updated 2026-08-31", "url": "https://m.base-donnees-publique.medicaments.gouv.fr/groupe-generique-736", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "regulatory_product_record", "market": "FR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-09", "reviewedAt": "2026-09-09" } }, { "name": "FORLAX", "market": { "zh": "新加坡", "en": "Singapore" }, "evidenceStatus": "dated_public_record", "note": { "zh": "SIN12419P；10 g/袋。", "en": "SIN12419P; 10 g/sachet." }, "source": { "id": "src_cf622b3da4f1b989", "label": "Singapore NDF: FORLAX 10 G/SACHET, SIN12419P; updated 2026-07-28", "url": "https://www.ndf.gov.sg/about-drugs/product-information/sin12419p/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "regulatory_product_record", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-09", "reviewedAt": "2026-09-09" } }, { "name": "福松®", "market": { "zh": "中国大陆：历史名称线索", "en": "Mainland China: historical name cue" }, "evidenceStatus": "dated_public_record", "note": { "zh": "2020 年益普生公告；不是现行批准、医保或在售证明。", "en": "Ipsen release from 2020; not current authorisation, reimbursement or stock evidence." }, "source": { "id": "src_cc8fa229818452fd", "label": "Ipsen company release via PR Newswire, 2020-08-18: Forlax (macrogol 4000 powder) Chinese brand and partnership history", "url": "https://www.prnasia.com/story/288529-1.shtml", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "manufacturer_history", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-09", "reviewedAt": "2026-09-09" } } ], "mainlandChinaTradeNameCue": { "value": "福松®", "status": "discovery_cue_requires_target_market_verification", "source": { "id": "src_cc8fa229818452fd", "label": "Ipsen company release via PR Newswire, 2020-08-18: Forlax (macrogol 4000 powder) Chinese brand and partnership history", "url": "https://www.prnasia.com/story/288529-1.shtml", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "manufacturer_history", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-09", "reviewedAt": "2026-09-09" } } }, "identity": { "therapeuticArea": "消化系统", "sourceArchiveMarket": "法国 10 g 粉末说明书、新加坡记录及中国品牌历史；中国现行批准原件待核验。", "dosageFormClass": "口服固体制剂", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "1995（法国批准记录）", "archiveSponsorText": "Mayoly Pharma France" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [ "福松", "聚乙二醇4000", "聚乙二醇4000散", "Forlax", "macrogol 4000" ], "excludedProductCues": [ "macrogol 3350", "polyethylene glycol 3350", "聚乙二醇3350", "乳果糖", "lactulose" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "fr-forlax-macrogol4000-10g-20-sachets", "marketCode": "FR", "labelVersion": { "zh": "法国说明书 2026-02-20", "en": "French leaflet 20 February 2026" }, "dosageForm": { "zh": "冲配为口服溶液的粉末", "en": "Powder for oral solution" }, "route": { "zh": "口服", "en": "Oral" }, "routeCodes": [ "oral" ], "productCode": "3400933899783", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_packet", "primaryDisplay": { "zh": "每袋聚乙二醇4000 10 g；整袋粉末 10.167 g；20 袋/盒", "en": "10 g macrogol 4000 per sachet; 10.167 g total powder; 20 sachets/carton" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "聚乙二醇4000", "en": "macrogol 4000" }, "value": 10, "unit": "g", "basisCode": "per_packet", "basisLabel": { "zh": "每袋成分含量", "en": "Active amount per sachet" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-09", "currentLabelDisplayed": false, "ndcDirectoryListed": false, "marketAvailability": "label_listed_not_live_supply", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 20, "unit": { "zh": "袋/盒", "en": "sachets/carton" } }, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_8a2fa1551a6f17a1", "label": "France public medicines database / ANSM: FORLAX 10 g, CIS 69298346; leaflet updated 2026-02-20", "url": "https://base-donnees-publique.medicaments.gouv.fr/medicament/69298346/extrait", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "FR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-09", "reviewedAt": "2026-09-09" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "status": "withheld_repackaged_or_non_exact_visual", "title": { "zh": "准确包装的官方照片仍待补齐", "en": "Exact official pack photograph still needed" }, "summary": { "zh": "不以海外其他规格或电商图片代替中国药盒；这张法国文字卡不能鉴定真伪。", "en": "Other strengths or retail pictures do not stand in for a Chinese pack; this French text card cannot authenticate a medicine." }, "source": { "id": "src_8a2fa1551a6f17a1", "label": "France public medicines database / ANSM: FORLAX 10 g, CIS 69298346; leaflet updated 2026-02-20", "url": "https://base-donnees-publique.medicaments.gouv.fr/medicament/69298346/extrait", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "FR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-09", "reviewedAt": "2026-09-09" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "大字读法国说明书：含量与老人用药核对", "en": "Large-print French leaflet: strength and older-person checks" }, "summary": { "zh": "先分清成分、粉末总重与盒内袋数。以下是法国原件阅读要点。", "en": "Separate active amount, total powder mass and pack count. These points refer to the French original." }, "checks": [ { "zh": "10 g 是每袋成分含量；10.167 g 包含辅料；20 是盒内袋数。实际用几袋要核对本人处方与本地说明书。", "en": "10 g is active amount per sachet; 10.167 g includes excipients; 20 is pack count. Check your prescription and local leaflet for your dose." }, { "zh": "老人、肾肝功能问题或使用利尿药者若发生腹泻，要注意水分与电解质丢失，并联系医护人员。", "en": "Diarrhoea needs attention to fluid and electrolyte loss, particularly in older people or those with kidney/liver problems or diuretic use." }, { "zh": "可能暂时影响其他口服药吸收；把完整药单交给药师核对，不能仅凭错开时间判定安全。", "en": "Other oral medicines may be absorbed less well temporarily. Ask a pharmacist to review the full list; spacing alone does not establish safety." }, { "zh": "怀疑肠梗阻、肠穿孔或不明原因腹痛时不要自行用药；呼吸困难或面喉肿胀应立即急救。", "en": "Do not self-treat suspected obstruction, perforation or unexplained abdominal pain; breathing difficulty or face/throat swelling needs emergency help." } ], "source": { "id": "src_8a2fa1551a6f17a1", "label": "France public medicines database / ANSM: FORLAX 10 g, CIS 69298346; leaflet updated 2026-02-20", "url": "https://base-donnees-publique.medicaments.gouv.fr/medicament/69298346/extrait", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "FR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-09", "reviewedAt": "2026-09-09" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "帮助粪便保留水分，不是立刻催便", "en": "Helps stools retain water; not an instant effect" }, "summary": { "zh": "这是一种渗透性泻剂：让粪便中的水分增加，帮助改善便秘。", "en": "This osmotic laxative increases water in stools to help constipation." }, "checks": [ { "zh": "新加坡原件写明：粉末用水溶解后口服，一般需 24–48 小时起效。不要因尚未起效自行加量。", "en": "The Singapore original describes powder dissolved in water, usually working in 24–48 hours. Do not increase your dose just because it has not worked yet." }, { "zh": "该市场适应证为成人及 8 岁起儿童的便秘；更小儿童不能套用这款 10 g 产品。", "en": "Its local indication covers constipation in adults and children from eight; this 10 g product must not be extrapolated to younger children." }, { "zh": "新加坡原件限制自行用药不超过两周；持续或加重应咨询医护人员，严重腹泻、呕吐需尽快就医。", "en": "Singapore limits self-medication to two weeks. Persistent or worsening symptoms need review; severe diarrhoea or vomiting needs prompt care." } ], "source": { "id": "src_cf622b3da4f1b989", "label": "Singapore NDF: FORLAX 10 G/SACHET, SIN12419P; updated 2026-07-28", "url": "https://www.ndf.gov.sg/about-drugs/product-information/sin12419p/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "regulatory_product_record", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-09", "reviewedAt": "2026-09-09" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "Forlax", "generic": "聚乙二醇4000", "dosageFormClass": "口服固体制剂" }, "labelSource": { "id": "src_8a2fa1551a6f17a1", "label": "France public medicines database / ANSM: FORLAX 10 g, CIS 69298346; leaflet updated 2026-02-20", "url": "https://base-donnees-publique.medicaments.gouv.fr/medicament/69298346/extrait", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "FR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-09", "reviewedAt": "2026-09-09" }, "productRoutes": [ { "source": { "id": "src_8a2fa1551a6f17a1", "label": "France public medicines database / ANSM: FORLAX 10 g, CIS 69298346; leaflet updated 2026-02-20", "url": "https://base-donnees-publique.medicaments.gouv.fr/medicament/69298346/extrait", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "FR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-09", "reviewedAt": "2026-09-09" }, "status": "product_level_public_record_verified", "authority": { "zh": "法国药监 ANSM", "en": "ANSM" }, "market": { "zh": "法国", "en": "France" }, "recordType": { "zh": "政府药品数据库与公开说明书", "en": "Government medicines database and public leaflet" }, "reviewedAt": "2026-09-09", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_d1233b10aa106eac", "label": "France public medicines database: macrogol 4000 10 g reference group 736; updated 2026-08-31", "url": "https://m.base-donnees-publique.medicaments.gouv.fr/groupe-generique-736", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "regulatory_product_record", "market": "FR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-09", "reviewedAt": "2026-09-09" }, "status": "public_product_record_verified", "authority": { "zh": "公开产品记录来源", "en": "Public product-record source" }, "market": { "zh": "以原始文件为准", "en": "See original document" }, "recordType": { "zh": "公开产品记录", "en": "Public product record" }, "reviewedAt": "2026-09-09", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_cf622b3da4f1b989", "label": "Singapore NDF: FORLAX 10 G/SACHET, SIN12419P; updated 2026-07-28", "url": "https://www.ndf.gov.sg/about-drugs/product-information/sin12419p/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "regulatory_product_record", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-09", "reviewedAt": "2026-09-09" }, "status": "product_level_public_record_verified", "authority": { "zh": "新加坡国家药物目录 NDF", "en": "Singapore National Drug Formulary (NDF)" }, "market": { "zh": "新加坡", "en": "Singapore" }, "recordType": { "zh": "政府药物目录产品资料与说明书节选", "en": "Government drug formulary product information and leaflet excerpts" }, "reviewedAt": "2026-09-09", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "法国药监 ANSM", "en": "ANSM" }, "market": { "zh": "法国", "en": "France" }, "recordType": { "zh": "政府药品数据库与公开说明书", "en": "Government medicines database and public leaflet" }, "reviewedAt": "2026-09-09", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "福松的通用名是聚乙二醇4000散。它用于便秘，帮助粪便保留水分。先核对所在市场、每袋含量和说明书；“10 g”不是每个人都适用的服药指令。", "history": "法国本产品批准日期为 1995-05-05。益普生 2020-08-18 企业公告记载福松（聚乙二醇4000散）在中国的合作历史；企业公告仅作为中文品牌线索，不代替现行药监批准原件。", "sourceDocuments": [ { "id": "src_8a2fa1551a6f17a1", "label": "France public medicines database / ANSM: FORLAX 10 g, CIS 69298346; leaflet updated 2026-02-20", "url": "https://base-donnees-publique.medicaments.gouv.fr/medicament/69298346/extrait", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "FR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-09", "reviewedAt": "2026-09-09" }, { "id": "src_d1233b10aa106eac", "label": "France public medicines database: macrogol 4000 10 g reference group 736; updated 2026-08-31", "url": "https://m.base-donnees-publique.medicaments.gouv.fr/groupe-generique-736", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "regulatory_product_record", "market": "FR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-09", "reviewedAt": "2026-09-09" }, { "id": "src_cf622b3da4f1b989", "label": "Singapore NDF: FORLAX 10 G/SACHET, SIN12419P; updated 2026-07-28", "url": "https://www.ndf.gov.sg/about-drugs/product-information/sin12419p/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "regulatory_product_record", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-09", "reviewedAt": "2026-09-09" }, { "id": "src_7e3d3c3985cb3695", "label": "MHRA Drug Safety Update, 2021-04-27: PEG laxatives and starch-based thickeners, aspiration risk", "url": "https://www.gov.uk/drug-safety-update/polyethylene-glycol-peg-laxatives-and-starch-based-thickeners-potential-interactive-effect-when-mixed-leading-to-an-increased-risk-of-aspiration", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-09", "reviewedAt": "2026-09-09" }, { "id": "src_cc8fa229818452fd", "label": "Ipsen company release via PR Newswire, 2020-08-18: Forlax (macrogol 4000 powder) Chinese brand and partnership history", "url": "https://www.prnasia.com/story/288529-1.shtml", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "manufacturer_history", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-09", "reviewedAt": "2026-09-09" } ], "applicationNumber": "FR CIS 69298346; CIP 3400933899783; SG SIN12419P", "approvalTimeline": [ { "date": "1995-05-05", "title": { "zh": "法国批准记录", "en": "French authorisation record" }, "detail": { "zh": "这是该产品在法国的日期，不代表全球所有剂型的首发。", "en": "Product-specific French date, not a global first-launch claim for all forms." }, "source": { "id": "src_8a2fa1551a6f17a1", "label": "France public medicines database / ANSM: FORLAX 10 g, CIS 69298346; leaflet updated 2026-02-20", "url": "https://base-donnees-publique.medicaments.gouv.fr/medicament/69298346/extrait", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "FR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-09", "reviewedAt": "2026-09-09" } }, { "date": "2020-08-18", "title": { "zh": "中国中文品牌历史线索", "en": "Chinese brand-history evidence" }, "detail": { "zh": "益普生发布福松与上药控股合作公告。", "en": "Ipsen announced a Forlax partnership with Shanghai Pharma." }, "source": { "id": "src_cc8fa229818452fd", "label": "Ipsen company release via PR Newswire, 2020-08-18: Forlax (macrogol 4000 powder) Chinese brand and partnership history", "url": "https://www.prnasia.com/story/288529-1.shtml", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "manufacturer_history", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-09", "reviewedAt": "2026-09-09" } }, { "date": "2021-04-27", "title": { "zh": "药物警戒：淀粉增稠剂与误吸风险", "en": "Safety: starch thickeners and aspiration risk" }, "detail": { "zh": "英国 MHRA 提示：PEG 泻剂不要直接混入淀粉增稠的液体，可能使其变稀、增加吞咽困难者误吸风险。这是类药物安全提示，不是本品召回。", "en": "MHRA warns against directly mixing PEG laxatives with starch-thickened liquids: thinning may increase aspiration risk in dysphagia. This is a class warning, not a Forlax recall." }, "source": { "id": "src_7e3d3c3985cb3695", "label": "MHRA Drug Safety Update, 2021-04-27: PEG laxatives and starch-based thickeners, aspiration risk", "url": "https://www.gov.uk/drug-safety-update/polyethylene-glycol-peg-laxatives-and-starch-based-thickeners-potential-interactive-effect-when-mixed-leading-to-an-increased-risk-of-aspiration", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-09", "reviewedAt": "2026-09-09" } } ], "marketStatus": [ { "market": { "zh": "法国", "en": "France" }, "status": { "zh": "参比组与说明书已核对", "en": "Reference group and leaflet checked" }, "detail": { "zh": "本页展示 20 袋包装文字记录，不代表实时库存。", "en": "The 20-sachet text record is not live inventory." } }, { "market": { "zh": "新加坡", "en": "Singapore" }, "status": { "zh": "政府产品记录已核对", "en": "Government product record checked" }, "detail": { "zh": "持有人 DKSH Singapore；当地 GSL 分类不可直接套用中国。", "en": "Holder DKSH Singapore; local GSL classification does not establish Chinese supply status." } }, { "market": { "zh": "中国大陆", "en": "Mainland China" }, "status": { "zh": "现行批准与说明书待核验", "en": "Current authorisation and leaflet unverified" }, "detail": { "zh": "福松为历史品牌线索；本页未编造中国批准号或中国包装卡。", "en": "福松 is a historical brand cue; no Chinese authorisation number or pack is inferred." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "老人吃饭要用增稠剂，可以一起混吗？", "en": "Can a person using swallowing thickeners mix it in?" }, "answer": { "zh": "先让药师与吞咽照护人员核对增稠剂成分。淀粉增稠液遇 PEG 泻剂可能变稀，增加误吸风险；不要自行混配或据此调整液体稠度。见上方 2021 年 MHRA 原文。", "en": "Ask the pharmacist and swallowing-care team to check the thickener. PEG can thin starch-thickened liquids and increase aspiration risk. Do not improvise mixtures or thickness; see the dated MHRA source above." } }, { "question": { "zh": "聚乙二醇3350和4000是同一个包装吗？", "en": "Are PEG 3350 and 4000 the same presentation?" }, "answer": { "zh": "不能只凭“聚乙二醇”认定相同。请核完整成分、是否含电解质、剂型和本地说明书，再由药师判断具体产品关系。", "en": "Do not identify products by PEG alone. Check the full ingredient, electrolytes, form and local leaflet with a pharmacist." } }, { "question": { "zh": "参比药是否说明其他品牌都不能用？", "en": "Does reference status mean other brands cannot be used?" }, "answer": { "zh": "不是。法国参比组同时列有仿制产品，且部分辅料不同；身份与辅料信息不能单独替你决定换药。", "en": "No. The French group also lists generics, with some excipient differences. Identity and excipients alone do not decide a switch for you." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "dose-unit-literacy", "medicine-label-for-everyday-questions", "interactions-are-not-a-home-scheduling-problem" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/forlax-macrogol-4000/", "en": "https://origindrug.com/en/drugs/forlax-macrogol-4000/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "mucosolvan-ambroxol", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-09-09", "status": "published_traceable_archive" }, "names": { "brand": "Mucosolvan", "generic": "盐酸氨溴索", "aliases": [ "沐舒坦", "氨溴索", "盐酸氨溴索", "Mucosolvan", "ambroxol", "ambroxol hydrochloride" ], "marketBrandNames": [ { "name": "沐舒坦® / Mucosolvan", "market": { "zh": "中国大陆：品牌名称线索", "en": "Mainland China: brand-name cue" }, "evidenceStatus": "dated_public_record", "note": { "zh": "来源为 Opella 企业品牌页，不是现行批准、医保或库存证明。", "en": "Opella corporate brand page, not proof of current authorisation, reimbursement or stock." }, "source": { "id": "src_63d4f08ebd7a762a", "label": "Opella China: Mucosolvan Chinese brand-name information", "url": "https://www.opella.com/our-countries/zh-cn", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "manufacturer_history", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-09", "reviewedAt": "2026-09-09" } }, { "name": "MUCOSOLVAN", "market": { "zh": "新加坡", "en": "Singapore" }, "evidenceStatus": "dated_public_record", "note": { "zh": "30 mg 片剂与 75 mg 长效胶囊有不同登记号。", "en": "30 mg tablets and 75 mg prolonged-release capsules have separate registrations." }, "source": { "id": "src_a421b96dae9b2a41", "label": "Singapore NDF: MUCOSOLVAN TABLET 30 MG, SIN02696P; updated 2026-07-28", "url": "https://www.ndf.gov.sg/about-drugs/product-information/sin02696p/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "regulatory_product_record", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-09", "reviewedAt": "2026-09-09" } }, { "name": "MUCOSOLVAN LIQUID", "market": { "zh": "马来西亚", "en": "Malaysia" }, "evidenceStatus": "dated_public_record", "note": { "zh": "30 mg/5 mL；本次登记页列 100 mL 包装。", "en": "30 mg/5 mL; the checked register lists a 100 mL pack." }, "source": { "id": "src_96a9eb5120b3164d", "label": "Malaysia NPRA QUEST3+: MUCOSOLVAN LIQUID 30MG/5ML, MAL19987339XC, 100 mL", "url": "https://quest3plus.bpfk.gov.my/pmo2/detail.php?id=MAL19987339X&type=product", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "regulatory_product_record", "market": "MY", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-09", "reviewedAt": "2026-09-09" } } ], "mainlandChinaTradeNameCue": { "value": "沐舒坦®", "status": "discovery_cue_requires_target_market_verification", "source": { "id": "src_63d4f08ebd7a762a", "label": "Opella China: Mucosolvan Chinese brand-name information", "url": "https://www.opella.com/our-countries/zh-cn", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "manufacturer_history", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-09", "reviewedAt": "2026-09-09" } } }, "identity": { "therapeuticArea": "呼吸系统", "sourceArchiveMarket": "新加坡片剂与长效胶囊记录、马来西亚口服液原件；中国品牌名称线索另列。", "dosageFormClass": "口服制剂", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "首发年份待核验", "archiveSponsorText": "Opella Healthcare Singapore / DKSH Malaysia (market-specific)" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [ "沐舒坦", "氨溴索", "盐酸氨溴索", "Mucosolvan", "ambroxol" ], "excludedProductCues": [ "bromhexine", "溴己新", "Spasmo-Mucosolvan", "clenbuterol", "克仑特罗" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "my-mucosolvan-30mg-5ml-100ml", "marketCode": "MY", "labelVersion": { "zh": "马来西亚说明书 2022-08-09", "en": "Malaysian leaflet 9 August 2022" }, "dosageForm": { "zh": "口服液", "en": "Oral liquid" }, "route": { "zh": "口服", "en": "Oral" }, "routeCodes": [ "oral" ], "productCode": "MAL19987339XC", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_5_mL", "primaryDisplay": { "zh": "每 5 mL 含盐酸氨溴索 30 mg；100 mL/瓶", "en": "30 mg ambroxol hydrochloride per 5 mL; 100 mL bottle" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "盐酸氨溴索", "en": "ambroxol hydrochloride" }, "value": 30, "unit": "mg", "basisCode": "per_5_mL", "basisLabel": { "zh": "每 5 毫升的成分含量", "en": "Active amount per 5 mL" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-09", "currentLabelDisplayed": false, "ndcDirectoryListed": false, "marketAvailability": "label_listed_not_live_supply", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "mL/瓶", "en": "mL/bottle" } }, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_96a9eb5120b3164d", "label": "Malaysia NPRA QUEST3+: MUCOSOLVAN LIQUID 30MG/5ML, MAL19987339XC, 100 mL", "url": "https://quest3plus.bpfk.gov.my/pmo2/detail.php?id=MAL19987339X&type=product", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "regulatory_product_record", "market": "MY", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-09", "reviewedAt": "2026-09-09" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "status": "withheld_repackaged_or_non_exact_visual", "title": { "zh": "包装照片暂不展示", "en": "Exact pack photograph not yet available" }, "summary": { "zh": "本页有马来西亚包装文字记录，未取得与该规格对应的准确官方照片；不以其他市场图片代替，也不凭外观判断真伪。", "en": "The Malaysian pack has a text record but no verified exact official photograph. Other-market images are not substituted; appearance cannot authenticate it." }, "source": { "id": "src_96a9eb5120b3164d", "label": "Malaysia NPRA QUEST3+: MUCOSOLVAN LIQUID 30MG/5ML, MAL19987339XC, 100 mL", "url": "https://quest3plus.bpfk.gov.my/pmo2/detail.php?id=MAL19987339X&type=product", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "regulatory_product_record", "market": "MY", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-09", "reviewedAt": "2026-09-09" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "大字读口服液说明书：先看浓度，再看量具", "en": "Large-print liquid leaflet: concentration and measuring device" }, "summary": { "zh": "对应马来西亚 30 mg/5 mL 原件，不是中国说明书或个人用量表。", "en": "For the Malaysian 30 mg/5 mL original, not a Chinese leaflet or personal dose chart." }, "checks": [ { "zh": "30 mg/5 mL 表示每 5 毫升含 30 毫克；等于 6 mg/mL 只是浓度换算，不表示一次喝多少。", "en": "30 mg/5 mL equals 6 mg/mL as concentration only, not the amount to take." }, { "zh": "使用原包装随附量杯；家用勺子不能代替。肝肾问题、孕期或哺乳期先咨询医生或药师。", "en": "Use the supplied measuring cup, not a household spoon. Discuss liver/kidney problems, pregnancy or breastfeeding first." }, { "zh": "大量痰的呼吸疾病患者同时用抑制咳嗽的药，可能积痰；请把完整药单交给药师核对。", "en": "Cough suppressants can cause secretion accumulation in mucus-heavy respiratory disease; have the whole medicine list reviewed." }, { "zh": "出现新的皮肤或黏膜损伤应停用并立即就医；呼吸困难、面喉肿胀等严重过敏表现应立即急救。", "en": "Stop and seek immediate medical review for new skin/mucosal lesions; breathing difficulty or facial/throat swelling needs emergency care." } ], "source": { "id": "src_434042b9b1bb97b5", "label": "Malaysia NPRA: MUCOSOLVAN LIQUID 30MG/5ML English patient leaflet; revised 2022-08-09", "url": "https://quest3plus.bpfk.gov.my/front-end/attachment/66/pharma/233086/V_67789_20220908_115445_D4.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "MY", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-09", "reviewedAt": "2026-09-09" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "帮助黏痰变稀，不是所有咳嗽都用同一种药", "en": "Helps thin thick mucus; cough medicines differ" }, "summary": { "zh": "新加坡片剂记录的用途是帮助清除气道中的黏稠分泌物。", "en": "The Singapore tablet record describes clearing thick airway secretions." }, "checks": [ { "zh": "氨溴索有助于稀释黏液；“祛痰”和“抑制咳嗽反射”不是同一件事。", "en": "Ambroxol helps thin mucus; clearing mucus and suppressing the cough reflex are not the same task." }, { "zh": "该记录要求片剂整片吞服；30 mg 是每片含量，不是每个人都通用的服药指令。", "en": "The record instructs swallowing tablets whole; 30 mg is per-tablet strength, not universal dosing advice." }, { "zh": "症状加重或 4–5 天仍不改善应咨询医生；不足 2 岁儿童不要自行套用成人产品。", "en": "Consult a doctor if symptoms worsen or fail to improve after 4–5 days. Do not extrapolate adult products to children under two." } ], "source": { "id": "src_a421b96dae9b2a41", "label": "Singapore NDF: MUCOSOLVAN TABLET 30 MG, SIN02696P; updated 2026-07-28", "url": "https://www.ndf.gov.sg/about-drugs/product-information/sin02696p/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "regulatory_product_record", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-09", "reviewedAt": "2026-09-09" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "Mucosolvan", "generic": "盐酸氨溴索", "dosageFormClass": "口服制剂" }, "labelSource": { "id": "src_434042b9b1bb97b5", "label": "Malaysia NPRA: MUCOSOLVAN LIQUID 30MG/5ML English patient leaflet; revised 2022-08-09", "url": "https://quest3plus.bpfk.gov.my/front-end/attachment/66/pharma/233086/V_67789_20220908_115445_D4.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "MY", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-09", "reviewedAt": "2026-09-09" }, "productRoutes": [ { "source": { "id": "src_434042b9b1bb97b5", "label": "Malaysia NPRA: MUCOSOLVAN LIQUID 30MG/5ML English patient leaflet; revised 2022-08-09", "url": "https://quest3plus.bpfk.gov.my/front-end/attachment/66/pharma/233086/V_67789_20220908_115445_D4.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "MY", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-09", "reviewedAt": "2026-09-09" }, "status": "product_level_public_record_verified", "authority": { "zh": "马来西亚药监 NPRA QUEST3+", "en": "Malaysia NPRA QUEST3+" }, "market": { "zh": "马来西亚", "en": "Malaysia" }, "recordType": { "zh": "监管产品登记或公开患者说明书", "en": "Regulatory product register or public patient leaflet" }, "reviewedAt": "2026-09-09", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_a421b96dae9b2a41", "label": "Singapore NDF: MUCOSOLVAN TABLET 30 MG, SIN02696P; updated 2026-07-28", "url": "https://www.ndf.gov.sg/about-drugs/product-information/sin02696p/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "regulatory_product_record", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-09", "reviewedAt": "2026-09-09" }, "status": "product_level_public_record_verified", "authority": { "zh": "新加坡国家药物目录 NDF", "en": "Singapore National Drug Formulary (NDF)" }, "market": { "zh": "新加坡", "en": "Singapore" }, "recordType": { "zh": "政府药物目录产品资料与说明书节选", "en": "Government drug formulary product information and leaflet excerpts" }, "reviewedAt": "2026-09-09", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_3cd64e4993990595", "label": "Singapore NDF: MUCOSOLVAN 24 HOURS CAPSULE 75MG, SIN13373P; updated 2026-07-28", "url": "https://www.ndf.gov.sg/about-drugs/product-information/sin13373p/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "regulatory_product_record", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-09", "reviewedAt": "2026-09-09" }, "status": "product_level_public_record_verified", "authority": { "zh": "新加坡国家药物目录 NDF", "en": "Singapore National Drug Formulary (NDF)" }, "market": { "zh": "新加坡", "en": "Singapore" }, "recordType": { "zh": "政府药物目录产品资料与说明书节选", "en": "Government drug formulary product information and leaflet excerpts" }, "reviewedAt": "2026-09-09", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_96a9eb5120b3164d", "label": "Malaysia NPRA QUEST3+: MUCOSOLVAN LIQUID 30MG/5ML, MAL19987339XC, 100 mL", "url": "https://quest3plus.bpfk.gov.my/pmo2/detail.php?id=MAL19987339X&type=product", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "regulatory_product_record", "market": "MY", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-09", "reviewedAt": "2026-09-09" }, "status": "product_level_public_record_verified", "authority": { "zh": "马来西亚药监 NPRA QUEST3+", "en": "Malaysia NPRA QUEST3+" }, "market": { "zh": "马来西亚", "en": "Malaysia" }, "recordType": { "zh": "监管产品登记或公开患者说明书", "en": "Regulatory product register or public patient leaflet" }, "reviewedAt": "2026-09-09", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "马来西亚药监 NPRA QUEST3+", "en": "Malaysia NPRA QUEST3+" }, "market": { "zh": "马来西亚", "en": "Malaysia" }, "recordType": { "zh": "监管产品登记或公开患者说明书", "en": "Regulatory product register or public patient leaflet" }, "reviewedAt": "2026-09-09", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "沐舒坦的成分是氨溴索，用于帮助稀释黏痰。先看清是片剂、口服液还是长效胶囊，再核对每片或每毫升的含量。不同剂型不能只按数字自行换算服用。", "history": "本档案保留 2015 年有日期安全通报、2022 年马来西亚说明书与 2026 年新加坡产品记录。这些是文件日期，不是全球上市年份；中国现行批准号仍待独立核验。", "sourceDocuments": [ { "id": "src_a421b96dae9b2a41", "label": "Singapore NDF: MUCOSOLVAN TABLET 30 MG, SIN02696P; updated 2026-07-28", "url": "https://www.ndf.gov.sg/about-drugs/product-information/sin02696p/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "regulatory_product_record", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-09", "reviewedAt": "2026-09-09" }, { "id": "src_3cd64e4993990595", "label": "Singapore NDF: MUCOSOLVAN 24 HOURS CAPSULE 75MG, SIN13373P; updated 2026-07-28", "url": "https://www.ndf.gov.sg/about-drugs/product-information/sin13373p/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "regulatory_product_record", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-09", "reviewedAt": "2026-09-09" }, { "id": "src_96a9eb5120b3164d", "label": "Malaysia NPRA QUEST3+: MUCOSOLVAN LIQUID 30MG/5ML, MAL19987339XC, 100 mL", "url": "https://quest3plus.bpfk.gov.my/pmo2/detail.php?id=MAL19987339X&type=product", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "regulatory_product_record", "market": "MY", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-09", "reviewedAt": "2026-09-09" }, { "id": "src_434042b9b1bb97b5", "label": "Malaysia NPRA: MUCOSOLVAN LIQUID 30MG/5ML English patient leaflet; revised 2022-08-09", "url": "https://quest3plus.bpfk.gov.my/front-end/attachment/66/pharma/233086/V_67789_20220908_115445_D4.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "MY", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-09", "reviewedAt": "2026-09-09" }, { "id": "src_63d4f08ebd7a762a", "label": "Opella China: Mucosolvan Chinese brand-name information", "url": "https://www.opella.com/our-countries/zh-cn", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "manufacturer_history", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-09", "reviewedAt": "2026-09-09" }, { "id": "src_08899bde40ddf372", "label": "Hong Kong Drug Office, 2015-01-13: EMA PRAC review of ambroxol/bromhexine allergy and severe skin reactions", "url": "https://www.drugoffice.gov.hk/eps/news/showNews/European%2BUnion%3A%2BPRAC%2Bconsiders%2Brisk%2Bof%2Bsevere%2Ballergic%2Breactions%2Bwith%2Bambroxol-%2Band%2Bbromhexine-containing%2Bmedicines%2Bto%2Bbe%2Bsmall/consumer/2015-01-13/en/24251.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "safety_communication", "market": "HK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-09", "reviewedAt": "2026-09-09" } ], "applicationNumber": "SG SIN02696P; SG SIN13373P; MY MAL19987339XC", "approvalTimeline": [ { "date": "2015-01-13", "title": { "zh": "药物警戒：严重过敏与皮肤反应", "en": "Safety: severe allergy and skin reactions" }, "detail": { "zh": "香港药物办公室转述 EMA PRAC 的类别安全审查，建议更新说明书。此为历史安全通报，不是当前沐舒坦召回或停产通知。", "en": "Hong Kong Drug Office relayed the EMA PRAC class review recommending label updates. This dated warning is not a current Mucosolvan recall or discontinuation." }, "source": { "id": "src_08899bde40ddf372", "label": "Hong Kong Drug Office, 2015-01-13: EMA PRAC review of ambroxol/bromhexine allergy and severe skin reactions", "url": "https://www.drugoffice.gov.hk/eps/news/showNews/European%2BUnion%3A%2BPRAC%2Bconsiders%2Brisk%2Bof%2Bsevere%2Ballergic%2Breactions%2Bwith%2Bambroxol-%2Band%2Bbromhexine-containing%2Bmedicines%2Bto%2Bbe%2Bsmall/consumer/2015-01-13/en/24251.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "safety_communication", "market": "HK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-09", "reviewedAt": "2026-09-09" } }, { "date": "2022-08-09", "title": { "zh": "马来西亚口服液说明书修订", "en": "Malaysian liquid leaflet revision" }, "detail": { "zh": "三页英文原件，登记号 MAL19987339XC。", "en": "Three-page English original, MAL19987339XC." }, "source": { "id": "src_434042b9b1bb97b5", "label": "Malaysia NPRA: MUCOSOLVAN LIQUID 30MG/5ML English patient leaflet; revised 2022-08-09", "url": "https://quest3plus.bpfk.gov.my/front-end/attachment/66/pharma/233086/V_67789_20220908_115445_D4.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "MY", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-09", "reviewedAt": "2026-09-09" } }, { "date": "2026-07-28", "title": { "zh": "新加坡产品记录更新", "en": "Singapore product record update" }, "detail": { "zh": "NDF 提供产品与说明书节选，不冒充完整患者说明书。", "en": "NDF provides product information and leaflet excerpts, not a complete patient leaflet." }, "source": { "id": "src_a421b96dae9b2a41", "label": "Singapore NDF: MUCOSOLVAN TABLET 30 MG, SIN02696P; updated 2026-07-28", "url": "https://www.ndf.gov.sg/about-drugs/product-information/sin02696p/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "regulatory_product_record", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-09", "reviewedAt": "2026-09-09" } } ], "marketStatus": [ { "market": { "zh": "新加坡", "en": "Singapore" }, "status": { "zh": "两种口服剂型记录已核对", "en": "Two oral-form records checked" }, "detail": { "zh": "片剂 SIN02696P；75 mg 长效胶囊 SIN13373P。当地持有人为 Opella Healthcare Singapore；不套用其他市场销售分类。", "en": "Tablet SIN02696P; 75 mg prolonged-release capsule SIN13373P. Local holder: Opella Healthcare Singapore; supply classifications are market-specific." } }, { "market": { "zh": "马来西亚", "en": "Malaysia" }, "status": { "zh": "口服液登记与原件已核对", "en": "Liquid register and original checked" }, "detail": { "zh": "登记页列 DKSH Malaysia 持有、Delpharm Reims 制造及 100 mL 包装；登记不等于实时库存。", "en": "Register: DKSH Malaysia holder, Delpharm Reims manufacturer and 100 mL pack; registration is not live stock." } }, { "market": { "zh": "中国大陆", "en": "Mainland China" }, "status": { "zh": "品牌名称已核；现行批准原件待补", "en": "Brand name checked; current approval original pending" }, "detail": { "zh": "不编造中国批准号、原研首发年份或中国药盒图片。", "en": "No Chinese authorisation number, first-launch year or pack image is invented." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "75 mg 长效胶囊能按总毫克换成片剂吗？", "en": "Can I convert the 75 mg long-acting capsule into tablets by milligrams?" }, "answer": { "zh": "不能自行换算。新加坡 SIN13373P 正文写 prolonged-release，剂型字段为 delayed release，且要求整粒吞服。它不是 SIN02696P 30 mg 片剂的简单倍数；由药师核对具体产品。", "en": "Do not self-convert. SIN13373P describes prolonged-release capsules, has a delayed-release form field, and instructs swallowing whole. It is not simply a multiple of the SIN02696P 30 mg tablet; check the exact products with a pharmacist." } }, { "question": { "zh": "瓶上 100 mL 是一次喝的量吗？", "en": "Does 100 mL on the bottle mean one dose?" }, "answer": { "zh": "不是。这是登记包装的总液体体积；一次用量需要同时核对浓度、量具和本人用法。", "en": "No. It is total pack volume. A dose also requires the concentration, measuring device and your own instructions." } }, { "question": { "zh": "溴己新和氨溴索是同一种药名吗？", "en": "Are bromhexine and ambroxol the same medicine name?" }, "answer": { "zh": "不是。虽然溴己新在体内主要转为氨溴索，两者仍是不同成分名称，不能据此自行等量替换或叠加。", "en": "No. Bromhexine is largely converted to ambroxol in the body, but these remain different ingredient identities, not permission for equal-dose substitution or combination." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "dose-unit-literacy", "medicine-label-for-everyday-questions", "interactions-are-not-a-home-scheduling-problem" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/mucosolvan-ambroxol/", "en": "https://origindrug.com/en/drugs/mucosolvan-ambroxol/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "cytomel-liothyronine", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-09-06", "status": "published_traceable_archive" }, "names": { "brand": "CYTOMEL", "generic": "碘塞罗宁钠", "aliases": [ "Cytomel", "liothyronine", "liothyronine sodium", "T3", "L-triiodothyronine", "碘塞罗宁", "碘塞罗宁钠", "碘塞罗宁钠片", "三碘甲状腺原氨酸" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "代谢", "sourceArchiveMarket": "美国：CYTOMEL 碘塞罗宁钠片 NDA 010379、5/25/50 mcg 三种当前品牌包装、现行电子说明书与 Orange Book RLD/RS 身份。该美国证据不外推中国大陆、欧盟、日本或其他市场的批准、商品名、包装、供应、原研/仿制关系或可替代性。", "dosageFormClass": "口服普通片 5、25、50 mcg；mcg 是微克，1 mg 等于 1000 mcg。网页不把微克与毫克、碘塞罗宁与左甲状腺素，或不同甲状腺制剂做个人换算。", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "1956（美国初始批准）", "archiveSponsorText": "Pfizer Laboratories Div Pfizer Inc（当前美国品牌标签所列）" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [ "CYTOMEL", "liothyronine", "liothyronine sodium", "碘塞罗宁", "碘塞罗宁钠" ], "excludedProductCues": [ "levothyroxine", "SYNTHROID", "EUTHYROX", "thyroid desiccated", "Armour Thyroid", "methimazole", "TAPAZOLE" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-cytomel-liothyronine-5mcg-100-tablet-bottle-ndc-6079311501", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国品牌标签（SPL v15；2026-05-18 生效；处方信息 2025-04 修订）", "en": "Current U.S. DailyMed brand label (SPL v15; effective 18 May 2026; prescribing information revised Apr 2025)" }, "dosageForm": { "zh": "CYTOMEL 碘塞罗宁钠口服片", "en": "CYTOMEL liothyronine sodium oral tablet" }, "route": { "zh": "口服（准确产品身份字段）", "en": "oral (exact product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 60793-115-01", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片相当于碘塞罗宁 5 mcg（微克）；100 片瓶装", "en": "Equivalent to liothyronine 5 mcg per tablet; 100-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=cytomel-03.jpg&setid=51452b31-ff68-4e0c-b982-c15502ebf1d3", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "碘塞罗宁（以碘塞罗宁钠提供）", "en": "liothyronine (supplied as liothyronine sodium)" }, "value": 5, "unit": "mcg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、频率、换算或补服指令", "en": "labelled amount per tablet; not an individual tablet count, frequency, conversion or missed-use instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-06", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "白色至类白色", "en": "white to off-white" }, "shape": { "zh": "圆形、约 6 mm、无刻痕", "en": "round, approximately 6 mm, unscored" }, "imprint": "KPI;115", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_0667aacc8b5d56f0", "label": "DailyMed（NLM）：CYTOMEL 碘塞罗宁钠片当前美国品牌标签（SPL v15；2026-05-18 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=51452b31-ff68-4e0c-b982-c15502ebf1d3", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-06", "reviewedAt": "2026-09-06" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-cytomel-liothyronine-25mcg-100-tablet-bottle-ndc-6079311601", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国品牌标签（SPL v15；2026-05-18 生效；处方信息 2025-04 修订）", "en": "Current U.S. DailyMed brand label (SPL v15; effective 18 May 2026; prescribing information revised Apr 2025)" }, "dosageForm": { "zh": "CYTOMEL 碘塞罗宁钠口服片", "en": "CYTOMEL liothyronine sodium oral tablet" }, "route": { "zh": "口服（准确产品身份字段）", "en": "oral (exact product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 60793-116-01", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片相当于碘塞罗宁 25 mcg（微克）；100 片瓶装", "en": "Equivalent to liothyronine 25 mcg per tablet; 100-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=cytomel-04.jpg&setid=51452b31-ff68-4e0c-b982-c15502ebf1d3", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "碘塞罗宁（以碘塞罗宁钠提供）", "en": "liothyronine (supplied as liothyronine sodium)" }, "value": 25, "unit": "mcg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、频率、换算或补服指令", "en": "labelled amount per tablet; not an individual tablet count, frequency, conversion or missed-use instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-06", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "白色至类白色", "en": "white to off-white" }, "shape": { "zh": "圆形、约 7 mm、有刻痕", "en": "round, approximately 7 mm, scored" }, "imprint": "KPI;116", "scoreStatus": "scored_status_not_a_split_instruction", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_0667aacc8b5d56f0", "label": "DailyMed（NLM）：CYTOMEL 碘塞罗宁钠片当前美国品牌标签（SPL v15；2026-05-18 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=51452b31-ff68-4e0c-b982-c15502ebf1d3", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-06", "reviewedAt": "2026-09-06" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-cytomel-liothyronine-50mcg-100-tablet-bottle-ndc-6079311701", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国品牌标签（SPL v15；2026-05-18 生效；处方信息 2025-04 修订）", "en": "Current U.S. DailyMed brand label (SPL v15; effective 18 May 2026; prescribing information revised Apr 2025)" }, "dosageForm": { "zh": "CYTOMEL 碘塞罗宁钠口服片", "en": "CYTOMEL liothyronine sodium oral tablet" }, "route": { "zh": "口服（准确产品身份字段）", "en": "oral (exact product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 60793-117-01", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片相当于碘塞罗宁 50 mcg（微克）；100 片瓶装", "en": "Equivalent to liothyronine 50 mcg per tablet; 100-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=cytomel-05.jpg&setid=51452b31-ff68-4e0c-b982-c15502ebf1d3", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "碘塞罗宁（以碘塞罗宁钠提供）", "en": "liothyronine (supplied as liothyronine sodium)" }, "value": 50, "unit": "mcg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、频率、换算或补服指令", "en": "labelled amount per tablet; not an individual tablet count, frequency, conversion or missed-use instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-06", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "白色至类白色", "en": "white to off-white" }, "shape": { "zh": "圆形、约 8 mm、有刻痕", "en": "round, approximately 8 mm, scored" }, "imprint": "KPI;117", "scoreStatus": "scored_status_not_a_split_instruction", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_0667aacc8b5d56f0", "label": "DailyMed（NLM）：CYTOMEL 碘塞罗宁钠片当前美国品牌标签（SPL v15；2026-05-18 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=51452b31-ff68-4e0c-b982-c15502ebf1d3", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-06", "reviewedAt": "2026-09-06" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-cytomel-liothyronine-25mcg-100-tablet-bottle-ndc-6079311601", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=cytomel-04.jpg&setid=51452b31-ff68-4e0c-b982-c15502ebf1d3", "alt": "CYTOMEL 碘塞罗宁钠 25 mcg、NDC 60793-116-01、100 片当前美国瓶装标签面板", "archiveMarket": "美国", "labelVersion": "DailyMed 当前美国品牌标签 SPL v15（2026-05-18 生效）", "presentation": "CYTOMEL 每片相当于碘塞罗宁 25 mcg，白色至类白色圆片，KPI/116 刻字，有刻痕，100 片瓶装。", "notice": "此图只对应一个准确美国品牌包装，用于核对品牌、通用名、每片微克含量、NDC 与瓶装数量；不用于鉴定真伪，不证明实时库存、另一规格、其他市场、购买资格、个人片数或可替代性。", "source": { "id": "src_0667aacc8b5d56f0", "label": "DailyMed（NLM）：CYTOMEL 碘塞罗宁钠片当前美国品牌标签（SPL v15；2026-05-18 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=51452b31-ff68-4e0c-b982-c15502ebf1d3", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-06", "reviewedAt": "2026-09-06" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "CYTOMEL 说明书放大阅读：先看 mcg，再看心脏、骨骼、血糖与药物相互作用", "en": "CYTOMEL enlarged label: start with mcg, then review cardiac, bone, glucose and interaction risks" }, "summary": { "zh": "当前标签把微克规格、老年心血管风险、过量导致的甲亢表现、骨密度、糖尿病控制、抗凝药和多类相互作用列为重点。网页帮助把药盒和问题带给专业人员，不计算个人剂量、片数、分片、换药或监测方案。", "en": "The current label prioritises microgram strengths, cardiovascular risk in older adults, hyperthyroid effects of overtreatment, bone density, diabetes control, anticoagulants and multiple interactions. The page helps bring the pack and questions to a professional; it does not calculate an individual dose, tablet count, split, switch or monitoring plan." }, "checks": [ { "zh": "5、25、50 mcg 是每片碘塞罗宁当量。mcg 是微克，mg 是毫克，1 mg 等于 1000 mcg；包装数字不能脱离单位相加，也不能把 25 mcg 错读成 25 mg 或据此推算片数。", "en": "The 5, 25 and 50 mcg figures are liothyronine equivalents per tablet. Mcg means micrograms, mg means milligrams, and 1 mg equals 1,000 mcg. Never detach a pack number from its unit, read 25 mcg as 25 mg or use it to calculate a tablet count." }, { "zh": "25 mcg 与 50 mcg 片有刻痕，5 mcg 片无刻痕；本站不把刻痕当作自行掰片许可。能否分片、如何取得准确小剂量、分片后的均一性和储存须针对实际产品与处方让药师确认。", "en": "The 25 and 50 mcg tablets are scored; the 5 mcg tablet is unscored. This site does not treat a score as permission to self-split. Ask a pharmacist about the exact product, prescription, dose accuracy, uniformity and storage before splitting." }, { "zh": "甲状腺激素过量可能增加心率并诱发心绞痛或心律失常；老人和有心血管疾病者风险更高，标签特别提到心房颤动。出现胸痛、明显心悸、晕厥、呼吸困难或急性意识异常应及时寻求当地医疗帮助，严重情况使用急救；不要自行停换或补服。", "en": "Thyroid-hormone overtreatment may increase heart rate and precipitate angina or arrhythmias. Risk is higher in older adults and people with cardiovascular disease, and the label specifically notes atrial fibrillation. Chest pain, marked palpitations, fainting, breathing difficulty or acute confusion requires prompt local care and emergency help when severe; do not self-stop, switch or catch up." }, { "zh": "CYTOMEL 有黑框警示：不能用于肥胖治疗或减肥。超出生理需要的剂量可能造成严重甚至危及生命的毒性；不要与减肥药、兴奋剂或其他甲状腺激素自行组合。", "en": "CYTOMEL carries a boxed warning: it is not for treatment of obesity or for weight loss. Doses beyond physiologic requirements can cause serious or life-threatening toxicity; do not self-combine it with weight-loss drugs, stimulants or other thyroid hormones." }, { "zh": "标签提示口服抗凝药（包括华法林类监测场景）、地高辛类、糖尿病药、三环类抗抑郁药、胆汁酸结合剂／离子交换树脂、利福平、苯巴比妥、胺碘酮等相互作用。药单同时出现时要让药师逐项核对并结合化验监测，不能根据网页自行错开、加减或停药。", "en": "The label describes interactions involving oral anticoagulants, including warfarin-type monitoring situations, digitalis glycosides, diabetes therapy, tricyclic antidepressants, bile-acid sequestrants/ion-exchange resins, rifampin, phenobarbital, amiodarone and others. Ask a pharmacist to review the complete list and relevant monitoring; do not self-separate, increase, reduce or stop medicines from the page." } ], "source": { "id": "src_0667aacc8b5d56f0", "label": "DailyMed（NLM）：CYTOMEL 碘塞罗宁钠片当前美国品牌标签（SPL v15；2026-05-18 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=51452b31-ff68-4e0c-b982-c15502ebf1d3", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-06", "reviewedAt": "2026-09-06" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "碘塞罗宁怎样起作用：T3 进入细胞核并调控基因转录与蛋白合成", "en": "How liothyronine works: T3 enters the cell nucleus and regulates gene transcription and protein synthesis" }, "summary": { "zh": "标签说明，T3 与 T4 进入细胞核，结合与 DNA 相连的甲状腺激素受体蛋白，形成的核受体复合物调控基因转录、信使 RNA 与细胞质蛋白合成。甲状腺激素的生理作用主要由 T3 产生，但机制不能替代诊断、化验解释或个人用药决定。", "en": "The label says T3 and T4 enter the cell nucleus and bind thyroid-receptor proteins attached to DNA. The nuclear-receptor complex regulates gene transcription, messenger RNA and cytoplasmic protein synthesis. Physiologic thyroid-hormone actions are produced predominantly by T3, but mechanism cannot replace diagnosis, laboratory interpretation or an individual treatment decision." }, "checks": [ { "zh": "碘塞罗宁是 T3，左甲状腺素是 T4；共同属于甲状腺激素不表示它们是同一种药，也不能按 5、25、50、75 或 100 这些数字自行换算、叠加、轮换或替代。", "en": "Liothyronine is T3 and levothyroxine is T4. Belonging to the thyroid-hormone family does not make them one medicine or allow self-conversion, combination, alternation or substitution using figures such as 5, 25, 50, 75 or 100." }, { "zh": "药效起始较快、另一种甲状腺制剂的残余效应可持续，并不构成自行切换的时间表。SYNTHROID、EUTHYROX、CYTOMEL、甲状腺片或其他产品同时出现在药单时，应先核对准确成分、单位、处方和化验计划。", "en": "A relatively rapid onset and residual effects of another thyroid preparation do not create a self-switch timetable. If SYNTHROID, EUTHYROX, CYTOMEL, desiccated thyroid or another product appears on the list, first review the exact ingredient, unit, prescription and laboratory plan." }, { "zh": "当前标签没有把全基因组筛查写成所有人使用 CYTOMEL 前的常规要求。心血管情况、年龄、妊娠、糖尿病、肾上腺功能、药物相互作用、症状和实验室结果需要结合具体问题解释，不能用基因检测替代。", "en": "The current label does not make whole-genome screening a routine prerequisite for everyone before CYTOMEL. Cardiovascular status, age, pregnancy, diabetes, adrenal function, interactions, symptoms and laboratory results require interpretation for the actual question and cannot be replaced by genomic testing." } ], "source": { "id": "src_0667aacc8b5d56f0", "label": "DailyMed（NLM）：CYTOMEL 碘塞罗宁钠片当前美国品牌标签（SPL v15；2026-05-18 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=51452b31-ff68-4e0c-b982-c15502ebf1d3", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-06", "reviewedAt": "2026-09-06" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "CYTOMEL", "generic": "碘塞罗宁钠", "dosageFormClass": "口服普通片 5、25、50 mcg；mcg 是微克，1 mg 等于 1000 mcg。网页不把微克与毫克、碘塞罗宁与左甲状腺素，或不同甲状腺制剂做个人换算。" }, "labelSource": { "id": "src_0667aacc8b5d56f0", "label": "DailyMed（NLM）：CYTOMEL 碘塞罗宁钠片当前美国品牌标签（SPL v15；2026-05-18 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=51452b31-ff68-4e0c-b982-c15502ebf1d3", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-06", "reviewedAt": "2026-09-06" }, "productRoutes": [ { "source": { "id": "src_0667aacc8b5d56f0", "label": "DailyMed（NLM）：CYTOMEL 碘塞罗宁钠片当前美国品牌标签（SPL v15；2026-05-18 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=51452b31-ff68-4e0c-b982-c15502ebf1d3", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-06", "reviewedAt": "2026-09-06" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-09-06", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_3d17358ce65b1cf8", "label": "FDA Orange Book 第 46 版（2026）：CYTOMEL NDA 010379、5/25/50 mcg 与 RLD/RS 身份", "url": "https://www.fda.gov/media/71474/download", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-09-02", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-09-06", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "CYTOMEL 是碘塞罗宁钠（T3）口服片。瓶身的 5、25、50 mcg 表示每片微克含量，不是毫克，也不是每天片数；5 mcg 不是 5 mg。老人和有心血管疾病的人需要特别留意心率、心绞痛和心律失常风险。它不能与 SYNTHROID／EUTHYROX 等左甲状腺素产品或其他甲状腺制剂按数字自行换算、叠加、轮换或停换。", "history": "CYTOMEL 在美国的初始批准可追溯至 1956 年。FDA 2019 年批准函记录 NDA 010379/S-057 对供应信息等标签内容的修订；DailyMed 当前记录为 SPL v15，生效日 2026-05-18，处方信息修订于 2025-04。本页把初始批准、当前标签、准确包装和实时供应严格分开。", "sourceDocuments": [ { "id": "src_0667aacc8b5d56f0", "label": "DailyMed（NLM）：CYTOMEL 碘塞罗宁钠片当前美国品牌标签（SPL v15；2026-05-18 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=51452b31-ff68-4e0c-b982-c15502ebf1d3", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-06", "reviewedAt": "2026-09-06" }, { "id": "src_9bafbf295435e70d", "label": "FDA：CYTOMEL NDA 010379/S-057 补充申请批准函（2019）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/010379Orig1s057ltr.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_regulatory_document", "documentKind": "regulatory_approval_letter", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-06", "reviewedAt": "2026-09-06" }, { "id": "src_3d17358ce65b1cf8", "label": "FDA Orange Book 第 46 版（2026）：CYTOMEL NDA 010379、5/25/50 mcg 与 RLD/RS 身份", "url": "https://www.fda.gov/media/71474/download", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" } ], "applicationNumber": "NDA 010379", "approvalTimeline": [ { "date": "1956-05-08", "title": { "zh": "CYTOMEL 在美国初始批准", "en": "Initial U.S. approval of CYTOMEL" }, "detail": { "zh": "DailyMed 三种当前产品表均列出 NDA 010379 与 1956-05-08 的营销起始日期；Orange Book 将 CYTOMEL 连接到同一 NDA。", "en": "All three current DailyMed product tables list NDA 010379 and a marketing start date of 8 May 1956; the Orange Book connects CYTOMEL to the same NDA." }, "source": { "id": "src_0667aacc8b5d56f0", "label": "DailyMed（NLM）：CYTOMEL 碘塞罗宁钠片当前美国品牌标签（SPL v15；2026-05-18 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=51452b31-ff68-4e0c-b982-c15502ebf1d3", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-06", "reviewedAt": "2026-09-06" } }, { "date": "2019-08-08", "title": { "zh": "FDA 批准 S-057 标签补充申请", "en": "FDA approved the S-057 labelling supplement" }, "detail": { "zh": "批准函说明修订供应信息以解决处方信息与 DailyMed 的差异，并作其他编辑调整。", "en": "The approval letter describes revisions to How Supplied to resolve discrepancies between prescribing information and DailyMed, plus other editorial changes." }, "source": { "id": "src_9bafbf295435e70d", "label": "FDA：CYTOMEL NDA 010379/S-057 补充申请批准函（2019）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/010379Orig1s057ltr.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_regulatory_document", "documentKind": "regulatory_approval_letter", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-06", "reviewedAt": "2026-09-06" } }, { "date": "2026-05-18", "title": { "zh": "DailyMed 当前 SPL v15 生效", "en": "Current DailyMed SPL v15 became effective" }, "detail": { "zh": "当前记录保留 5、25、50 mcg 三个品牌瓶装及 2025-04 修订的处方信息。", "en": "The current record retains three brand bottles at 5, 25 and 50 mcg and prescribing information revised Apr 2025." }, "source": { "id": "src_0667aacc8b5d56f0", "label": "DailyMed（NLM）：CYTOMEL 碘塞罗宁钠片当前美国品牌标签（SPL v15；2026-05-18 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=51452b31-ff68-4e0c-b982-c15502ebf1d3", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-06", "reviewedAt": "2026-09-06" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "当前品牌标签存在；NDA/RLD 身份已核验", "en": "Current brand label present; NDA/RLD identity verified" }, "detail": { "zh": "三种 NDC 和包装图来自同一当前 DailyMed 标签；市场可获得性与库存仍须向持证渠道实时核实。", "en": "All three NDCs and package panels come from one current DailyMed label. Market availability and stock still require real-time confirmation from an authorised channel." } }, { "market": { "zh": "中国大陆及其他市场", "en": "Mainland China and other markets" }, "status": { "zh": "准确市场产品记录待逐项建立", "en": "Exact market-product records not yet established" }, "detail": { "zh": "不从美国 CYTOMEL 名称、NDA、NDC 或外观推定当地批准、商品名、包装、供应、原研/仿制关系或可替代性。", "en": "No local approval, trade name, pack, supply, originator/generic relationship or interchangeability is inferred from the U.S. CYTOMEL name, NDA, NDC or appearance." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "25 mcg 是不是 25 mg？", "en": "Is 25 mcg the same as 25 mg?" }, "answer": { "zh": "不是。25 mcg 是 25 微克，等于 0.025 mg；单位相差 1000 倍。看到药盒数字时必须把数字与 mcg／μg／mg 一起读，不要据此自己算片数。", "en": "No. 25 mcg is 25 micrograms, equal to 0.025 mg; the units differ by a factor of 1,000. Read the number together with mcg/μg/mg and do not calculate your own tablet count." } }, { "question": { "zh": "有刻痕的 25 或 50 mcg 片能自己掰半吗？", "en": "Can a scored 25 or 50 mcg tablet be self-split?" }, "answer": { "zh": "刻痕先是产品外观和结构信息，不是网页给出的分片许可。是否可以分、如何保证所需剂量与储存，应让药师根据准确产品、处方和实际情况确认。", "en": "A score is first a product appearance and structure feature, not online permission to split. Ask a pharmacist whether the exact product can be divided and how dose accuracy and storage would be managed." } }, { "question": { "zh": "CYTOMEL 和 SYNTHROID／EUTHYROX 能自己换算或一起吃吗？", "en": "Can CYTOMEL be self-converted or combined with SYNTHROID/EUTHYROX?" }, "answer": { "zh": "不能。CYTOMEL 是 T3，SYNTHROID／EUTHYROX 是 T4 产品；剂型、药代、单位、相互作用和监测都不同。换药或合用只能由了解病史、完整药单和化验结果的专业人员决定。", "en": "No. CYTOMEL is T3, while SYNTHROID/EUTHYROX are T4 products. Formulation, pharmacokinetics, units, interactions and monitoring differ. A professional with the history, complete list and laboratory results must decide any switch or combination." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "dosage-forms-are-part-of-medicine-identity", "how-to-read-a-drug-label", "medicine-list-review-for-older-adults" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/cytomel-liothyronine/", "en": "https://origindrug.com/en/drugs/cytomel-liothyronine/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "mirapex-pramipexole", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-09-06", "status": "published_traceable_archive" }, "names": { "brand": "MIRAPEX / MIRAPEX ER", "generic": "盐酸普拉克索", "aliases": [ "Mirapex", "Mirapex ER", "pramipexole", "pramipexole dihydrochloride", "普拉克索", "盐酸普拉克索", "盐酸普拉克索片", "盐酸普拉克索缓释片", "MIRAPEX", "MIRAPEX ER", "森福罗" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": { "value": "森福罗®", "status": "discovery_cue_requires_target_market_verification", "source": { "id": "src_a92ef31704391cdb", "label": "烟台市人民政府：2024 年市直机关医院药品记录中的森福罗／盐酸普拉克索片 0.25 mg×30 片记录", "url": "https://www.yantai.gov.cn/art/2023/12/29/art_67240_3168957.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "government_medicine_listing", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-13", "reviewedAt": "2026-09-13" } } }, "identity": { "therapeuticArea": "神经与认知", "sourceArchiveMarket": "美国：MIRAPEX 普通片 NDA 020667 与 MIRAPEX ER 缓释片 NDA 022421 的历史品牌、规格、批准与停止销售记录；当前通用名标签作为安全阅读语境。页面不把历史 RLD、仍可访问的说明书或纸盒样稿写成当前库存，也不外推中国大陆、欧盟、日本或其他市场的商品名、批准、包装、供应及可替代性。", "dosageFormClass": "MIRAPEX 口服普通片历史规格为 0.125、0.25、0.5、0.75、1、1.25、1.5 mg；MIRAPEX ER 口服缓释片为 0.375、0.75、1.5、2.25、3、3.75、4.5 mg。普通片与缓释片的释放、标签用途和使用路径不同，不能只按总 mg 自行换算、拼接、掰分、轮换或替换。", "dosageFormClassCode": "oral_modified_release", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "1997（MIRAPEX 普通片美国首次批准）；2010（MIRAPEX ER 美国批准）", "archiveSponsorText": "Boehringer Ingelheim（美国历史原品牌申请主体）" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [ "MIRAPEX", "MIRAPEX ER", "pramipexole", "pramipexole dihydrochloride", "普拉克索", "盐酸普拉克索" ], "excludedProductCues": [ "ropinirole", "REQUIP", "rotigotine", "NEUPRO", "levodopa", "SINEMET", "STALEVO", "RYTARY", "CREXONT" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-mirapex-ir-2021-0-125mg", "marketCode": "US", "labelVersion": { "zh": "美国 FDA 2021-07 历史说明书，第 3 节；规格核对于 2026-09-10", "en": "U.S. FDA July 2021 historical label, section 3; strengths checked 2026-09-10" }, "dosageForm": { "zh": "盐酸普拉克索普通片", "en": "Pramipexole immediate-release tablet" }, "route": { "zh": "口服", "en": "Oral" }, "routeCodes": [ "oral" ], "productCode": null, "pouchCode": null, "applicationNumber": "NDA 020667", "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "0.125 mg／片（盐酸普拉克索一水合物；历史标签含量，不是服药片数）", "en": "0.125 mg per tablet (pramipexole dihydrochloride monohydrate; historical label strength, not a tablet-count instruction)" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "盐酸普拉克索一水合物", "en": "Pramipexole dihydrochloride monohydrate" }, "value": 0.125, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片", "en": "Per tablet" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-10", "currentLabelDisplayed": false, "ndcDirectoryListed": false, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": null, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_3204a292a1e803fe", "label": "FDA：MIRAPEX 盐酸普拉克索普通片处方信息（NDA 020667；2021-07 版本）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020667s044lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_regulatory_document", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-06", "reviewedAt": "2026-09-06" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-mirapex-ir-2021-0-25mg", "marketCode": "US", "labelVersion": { "zh": "美国 FDA 2021-07 历史说明书，第 3 节；规格核对于 2026-09-10", "en": "U.S. FDA July 2021 historical label, section 3; strengths checked 2026-09-10" }, "dosageForm": { "zh": "盐酸普拉克索普通片", "en": "Pramipexole immediate-release tablet" }, "route": { "zh": "口服", "en": "Oral" }, "routeCodes": [ "oral" ], "productCode": null, "pouchCode": null, "applicationNumber": "NDA 020667", "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "0.25 mg／片（盐酸普拉克索一水合物；历史标签含量，不是服药片数）", "en": "0.25 mg per tablet (pramipexole dihydrochloride monohydrate; historical label strength, not a tablet-count instruction)" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "盐酸普拉克索一水合物", "en": "Pramipexole dihydrochloride monohydrate" }, "value": 0.25, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片", "en": "Per tablet" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-10", "currentLabelDisplayed": false, "ndcDirectoryListed": false, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": null, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_3204a292a1e803fe", "label": "FDA：MIRAPEX 盐酸普拉克索普通片处方信息（NDA 020667；2021-07 版本）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020667s044lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_regulatory_document", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-06", "reviewedAt": "2026-09-06" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-mirapex-ir-2021-0-5mg", "marketCode": "US", "labelVersion": { "zh": "美国 FDA 2021-07 历史说明书，第 3 节；规格核对于 2026-09-10", "en": "U.S. FDA July 2021 historical label, section 3; strengths checked 2026-09-10" }, "dosageForm": { "zh": "盐酸普拉克索普通片", "en": "Pramipexole immediate-release tablet" }, "route": { "zh": "口服", "en": "Oral" }, "routeCodes": [ "oral" ], "productCode": null, "pouchCode": null, "applicationNumber": "NDA 020667", "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "0.5 mg／片（盐酸普拉克索一水合物；历史标签含量，不是服药片数）", "en": "0.5 mg per tablet (pramipexole dihydrochloride monohydrate; historical label strength, not a tablet-count instruction)" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "盐酸普拉克索一水合物", "en": "Pramipexole dihydrochloride monohydrate" }, "value": 0.5, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片", "en": "Per tablet" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-10", "currentLabelDisplayed": false, "ndcDirectoryListed": false, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": null, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_3204a292a1e803fe", "label": "FDA：MIRAPEX 盐酸普拉克索普通片处方信息（NDA 020667；2021-07 版本）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020667s044lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_regulatory_document", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-06", "reviewedAt": "2026-09-06" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-mirapex-ir-2021-0-75mg", "marketCode": "US", "labelVersion": { "zh": "美国 FDA 2021-07 历史说明书，第 3 节；规格核对于 2026-09-10", "en": "U.S. FDA July 2021 historical label, section 3; strengths checked 2026-09-10" }, "dosageForm": { "zh": "盐酸普拉克索普通片", "en": "Pramipexole immediate-release tablet" }, "route": { "zh": "口服", "en": "Oral" }, "routeCodes": [ "oral" ], "productCode": null, "pouchCode": null, "applicationNumber": "NDA 020667", "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "0.75 mg／片（盐酸普拉克索一水合物；历史标签含量，不是服药片数）", "en": "0.75 mg per tablet (pramipexole dihydrochloride monohydrate; historical label strength, not a tablet-count instruction)" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "盐酸普拉克索一水合物", "en": "Pramipexole dihydrochloride monohydrate" }, "value": 0.75, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片", "en": "Per tablet" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-10", "currentLabelDisplayed": false, "ndcDirectoryListed": false, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": null, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_3204a292a1e803fe", "label": "FDA：MIRAPEX 盐酸普拉克索普通片处方信息（NDA 020667；2021-07 版本）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020667s044lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_regulatory_document", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-06", "reviewedAt": "2026-09-06" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-mirapex-ir-2021-1mg", "marketCode": "US", "labelVersion": { "zh": "美国 FDA 2021-07 历史说明书，第 3 节；规格核对于 2026-09-10", "en": "U.S. FDA July 2021 historical label, section 3; strengths checked 2026-09-10" }, "dosageForm": { "zh": "盐酸普拉克索普通片", "en": "Pramipexole immediate-release tablet" }, "route": { "zh": "口服", "en": "Oral" }, "routeCodes": [ "oral" ], "productCode": null, "pouchCode": null, "applicationNumber": "NDA 020667", "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "1 mg／片（盐酸普拉克索一水合物；历史标签含量，不是服药片数）", "en": "1 mg per tablet (pramipexole dihydrochloride monohydrate; historical label strength, not a tablet-count instruction)" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "盐酸普拉克索一水合物", "en": "Pramipexole dihydrochloride monohydrate" }, "value": 1, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片", "en": "Per tablet" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-10", "currentLabelDisplayed": false, "ndcDirectoryListed": false, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": null, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_3204a292a1e803fe", "label": "FDA：MIRAPEX 盐酸普拉克索普通片处方信息（NDA 020667；2021-07 版本）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020667s044lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_regulatory_document", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-06", "reviewedAt": "2026-09-06" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-mirapex-ir-2021-1-5mg", "marketCode": "US", "labelVersion": { "zh": "美国 FDA 2021-07 历史说明书，第 3 节；规格核对于 2026-09-10", "en": "U.S. FDA July 2021 historical label, section 3; strengths checked 2026-09-10" }, "dosageForm": { "zh": "盐酸普拉克索普通片", "en": "Pramipexole immediate-release tablet" }, "route": { "zh": "口服", "en": "Oral" }, "routeCodes": [ "oral" ], "productCode": null, "pouchCode": null, "applicationNumber": "NDA 020667", "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "1.5 mg／片（盐酸普拉克索一水合物；历史标签含量，不是服药片数）", "en": "1.5 mg per tablet (pramipexole dihydrochloride monohydrate; historical label strength, not a tablet-count instruction)" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "盐酸普拉克索一水合物", "en": "Pramipexole dihydrochloride monohydrate" }, "value": 1.5, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片", "en": "Per tablet" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-10", "currentLabelDisplayed": false, "ndcDirectoryListed": false, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": null, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_3204a292a1e803fe", "label": "FDA：MIRAPEX 盐酸普拉克索普通片处方信息（NDA 020667；2021-07 版本）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020667s044lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_regulatory_document", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-06", "reviewedAt": "2026-09-06" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-mirapex-er-2021-0-375mg", "marketCode": "US", "labelVersion": { "zh": "美国 FDA 2021-07 历史说明书，第 3 节；规格核对于 2026-09-10", "en": "U.S. FDA July 2021 historical label, section 3; strengths checked 2026-09-10" }, "dosageForm": { "zh": "盐酸普拉克索缓释片", "en": "Pramipexole extended-release tablet" }, "route": { "zh": "口服", "en": "Oral" }, "routeCodes": [ "oral" ], "productCode": null, "pouchCode": null, "applicationNumber": "NDA 022421", "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "0.375 mg／片（盐酸普拉克索一水合物；历史标签含量，不是服药片数）", "en": "0.375 mg per tablet (pramipexole dihydrochloride monohydrate; historical label strength, not a tablet-count instruction)" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "盐酸普拉克索一水合物", "en": "Pramipexole dihydrochloride monohydrate" }, "value": 0.375, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片", "en": "Per tablet" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-10", "currentLabelDisplayed": false, "ndcDirectoryListed": false, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": null, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_023f34bc5fd4ce38", "label": "FDA：MIRAPEX ER 盐酸普拉克索缓释片处方信息（NDA 022421；2021-07 版本）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022421s022lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_regulatory_document", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-06", "reviewedAt": "2026-09-06" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-mirapex-er-2021-0-75mg", "marketCode": "US", "labelVersion": { "zh": "美国 FDA 2021-07 历史说明书，第 3 节；规格核对于 2026-09-10", "en": "U.S. FDA July 2021 historical label, section 3; strengths checked 2026-09-10" }, "dosageForm": { "zh": "盐酸普拉克索缓释片", "en": "Pramipexole extended-release tablet" }, "route": { "zh": "口服", "en": "Oral" }, "routeCodes": [ "oral" ], "productCode": null, "pouchCode": null, "applicationNumber": "NDA 022421", "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "0.75 mg／片（盐酸普拉克索一水合物；历史标签含量，不是服药片数）", "en": "0.75 mg per tablet (pramipexole dihydrochloride monohydrate; historical label strength, not a tablet-count instruction)" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "盐酸普拉克索一水合物", "en": "Pramipexole dihydrochloride monohydrate" }, "value": 0.75, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片", "en": "Per tablet" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-10", "currentLabelDisplayed": false, "ndcDirectoryListed": false, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": null, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_023f34bc5fd4ce38", "label": "FDA：MIRAPEX ER 盐酸普拉克索缓释片处方信息（NDA 022421；2021-07 版本）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022421s022lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_regulatory_document", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-06", "reviewedAt": "2026-09-06" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-mirapex-er-2021-1-5mg", "marketCode": "US", "labelVersion": { "zh": "美国 FDA 2021-07 历史说明书，第 3 节；规格核对于 2026-09-10", "en": "U.S. FDA July 2021 historical label, section 3; strengths checked 2026-09-10" }, "dosageForm": { "zh": "盐酸普拉克索缓释片", "en": "Pramipexole extended-release tablet" }, "route": { "zh": "口服", "en": "Oral" }, "routeCodes": [ "oral" ], "productCode": null, "pouchCode": null, "applicationNumber": "NDA 022421", "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "1.5 mg／片（盐酸普拉克索一水合物；历史标签含量，不是服药片数）", "en": "1.5 mg per tablet (pramipexole dihydrochloride monohydrate; historical label strength, not a tablet-count instruction)" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "盐酸普拉克索一水合物", "en": "Pramipexole dihydrochloride monohydrate" }, "value": 1.5, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片", "en": "Per tablet" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-10", "currentLabelDisplayed": false, "ndcDirectoryListed": false, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": null, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_023f34bc5fd4ce38", "label": "FDA：MIRAPEX ER 盐酸普拉克索缓释片处方信息（NDA 022421；2021-07 版本）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022421s022lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_regulatory_document", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-06", "reviewedAt": "2026-09-06" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-mirapex-er-2021-2-25mg", "marketCode": "US", "labelVersion": { "zh": "美国 FDA 2021-07 历史说明书，第 3 节；规格核对于 2026-09-10", "en": "U.S. FDA July 2021 historical label, section 3; strengths checked 2026-09-10" }, "dosageForm": { "zh": "盐酸普拉克索缓释片", "en": "Pramipexole extended-release tablet" }, "route": { "zh": "口服", "en": "Oral" }, "routeCodes": [ "oral" ], "productCode": null, "pouchCode": null, "applicationNumber": "NDA 022421", "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "2.25 mg／片（盐酸普拉克索一水合物；历史标签含量，不是服药片数）", "en": "2.25 mg per tablet (pramipexole dihydrochloride monohydrate; historical label strength, not a tablet-count instruction)" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "盐酸普拉克索一水合物", "en": "Pramipexole dihydrochloride monohydrate" }, "value": 2.25, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片", "en": "Per tablet" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-10", "currentLabelDisplayed": false, "ndcDirectoryListed": false, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": null, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_023f34bc5fd4ce38", "label": "FDA：MIRAPEX ER 盐酸普拉克索缓释片处方信息（NDA 022421；2021-07 版本）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022421s022lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_regulatory_document", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-06", "reviewedAt": "2026-09-06" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-mirapex-er-2021-3mg", "marketCode": "US", "labelVersion": { "zh": "美国 FDA 2021-07 历史说明书，第 3 节；规格核对于 2026-09-10", "en": "U.S. FDA July 2021 historical label, section 3; strengths checked 2026-09-10" }, "dosageForm": { "zh": "盐酸普拉克索缓释片", "en": "Pramipexole extended-release tablet" }, "route": { "zh": "口服", "en": "Oral" }, "routeCodes": [ "oral" ], "productCode": null, "pouchCode": null, "applicationNumber": "NDA 022421", "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "3 mg／片（盐酸普拉克索一水合物；历史标签含量，不是服药片数）", "en": "3 mg per tablet (pramipexole dihydrochloride monohydrate; historical label strength, not a tablet-count instruction)" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "盐酸普拉克索一水合物", "en": "Pramipexole dihydrochloride monohydrate" }, "value": 3, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片", "en": "Per tablet" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-10", "currentLabelDisplayed": false, "ndcDirectoryListed": false, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": null, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_023f34bc5fd4ce38", "label": "FDA：MIRAPEX ER 盐酸普拉克索缓释片处方信息（NDA 022421；2021-07 版本）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022421s022lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_regulatory_document", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-06", "reviewedAt": "2026-09-06" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-mirapex-er-2021-3-75mg", "marketCode": "US", "labelVersion": { "zh": "美国 FDA 2021-07 历史说明书，第 3 节；规格核对于 2026-09-10", "en": "U.S. FDA July 2021 historical label, section 3; strengths checked 2026-09-10" }, "dosageForm": { "zh": "盐酸普拉克索缓释片", "en": "Pramipexole extended-release tablet" }, "route": { "zh": "口服", "en": "Oral" }, "routeCodes": [ "oral" ], "productCode": null, "pouchCode": null, "applicationNumber": "NDA 022421", "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "3.75 mg／片（盐酸普拉克索一水合物；历史标签含量，不是服药片数）", "en": "3.75 mg per tablet (pramipexole dihydrochloride monohydrate; historical label strength, not a tablet-count instruction)" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "盐酸普拉克索一水合物", "en": "Pramipexole dihydrochloride monohydrate" }, "value": 3.75, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片", "en": "Per tablet" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-10", "currentLabelDisplayed": false, "ndcDirectoryListed": false, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": null, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_023f34bc5fd4ce38", "label": "FDA：MIRAPEX ER 盐酸普拉克索缓释片处方信息（NDA 022421；2021-07 版本）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022421s022lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_regulatory_document", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-06", "reviewedAt": "2026-09-06" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-mirapex-er-2021-4-5mg", "marketCode": "US", "labelVersion": { "zh": "美国 FDA 2021-07 历史说明书，第 3 节；规格核对于 2026-09-10", "en": "U.S. FDA July 2021 historical label, section 3; strengths checked 2026-09-10" }, "dosageForm": { "zh": "盐酸普拉克索缓释片", "en": "Pramipexole extended-release tablet" }, "route": { "zh": "口服", "en": "Oral" }, "routeCodes": [ "oral" ], "productCode": null, "pouchCode": null, "applicationNumber": "NDA 022421", "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "4.5 mg／片（盐酸普拉克索一水合物；历史标签含量，不是服药片数）", "en": "4.5 mg per tablet (pramipexole dihydrochloride monohydrate; historical label strength, not a tablet-count instruction)" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "盐酸普拉克索一水合物", "en": "Pramipexole dihydrochloride monohydrate" }, "value": 4.5, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片", "en": "Per tablet" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-10", "currentLabelDisplayed": false, "ndcDirectoryListed": false, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": null, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_023f34bc5fd4ce38", "label": "FDA：MIRAPEX ER 盐酸普拉克索缓释片处方信息（NDA 022421；2021-07 版本）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022421s022lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_regulatory_document", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-06", "reviewedAt": "2026-09-06" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "status": "withheld_repackaged_or_non_exact_visual", "title": { "zh": "暂不展示 MIRAPEX 包装图：有历史纸盒文件，但尚未保留可与全部准确规格一一对应的公开图片集", "en": "MIRAPEX pack images withheld: a historical carton document exists, but a complete exact presentation-matched public image set has not been retained" }, "summary": { "zh": "FDA 2020 文件包含 MIRAPEX 0.25 mg、NDC 0597-0184-61、100 片纸盒版面，但该单一历史纸盒不能代表七种普通片、七种 ER 缓释片、当前通用药或其他市场。为避免把纸盒样稿、再包装图片或另一规格误作准确当前包装，页面先不展示包装图，也不冒充原品牌当前外观；只保留官方文件入口。", "en": "An FDA 2020 document contains the historical MIRAPEX 0.25 mg, NDC 0597-0184-61, 100-tablet carton layout. That single historical carton cannot represent seven immediate-release strengths, seven ER strengths, current generics or another market. To avoid treating a dieline, repackaged image or another strength as an exact current pack, the page withholds pack imagery and does not present a supposed current originator appearance; it retains the official-document route instead." }, "source": { "id": "src_822acc19cb7aac1d", "label": "FDA：MIRAPEX 普通片 0.25 mg、NDC 0597-0184-61、100 片历史纸盒标签（2020 批准文件）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020667Orig1s039lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_regulatory_record", "documentKind": "carton_and_container_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-06", "reviewedAt": "2026-09-06" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "MIRAPEX／普拉克索说明书放大阅读：先分普通片与 ER，再看突然入睡、血压、行为和肾功能", "en": "MIRAPEX / pramipexole enlarged label: separate IR from ER, then review sudden sleep, blood pressure, behaviour and kidney function" }, "summary": { "zh": "说明书把突然入睡、嗜睡、体位性低血压、冲动控制、幻觉／精神病样行为、运动障碍、姿势异常、肾功能和停药反应列为重点。老人发生幻觉的风险更高，肾清除又可能随年龄下降；网页只提供核对路线，不计算个人剂量、频次、减量或换剂型。", "en": "The labels prioritise sudden sleep, somnolence, orthostatic hypotension, impulse-control problems, hallucinations/psychotic-like behaviour, dyskinesia, postural deformity, renal function and withdrawal symptoms. Hallucination risk is higher in older people and renal clearance may decline with age. The page provides a review route, not an individual dose, frequency, taper or formulation switch." }, "checks": [ { "zh": "可能在没有明显预警的情况下于日常活动中突然入睡。出现开车、吃饭、谈话或其他活动中睡着、异常嗜睡、意识异常或事故风险时，应停止危险活动并尽快联系临床团队；严重急性情况使用当地急救。", "en": "Sudden sleep can occur during daily activities without clear warning. Falling asleep while driving, eating, talking or another activity, unusual somnolence, altered awareness or accident risk requires stopping hazardous activity and prompt clinical contact; severe acute situations require local emergency help." }, { "zh": "开始或增加时可能出现体位性低血压、头晕或晕厥。老人、脱水、降压药或其他会导致嗜睡／低血压的药同处药单时，要优先核对跌倒风险；不要自行补服、停药或改时间。", "en": "Orthostatic hypotension, dizziness or fainting can occur during initiation or escalation. Older age, dehydration, antihypertensives or other sedating/hypotensive medicines requires priority fall-risk review; do not self-catch up, stop or reschedule." }, { "zh": "照护者也应留意赌博、购物、进食、性行为或其他难以控制的冲动，以及幻觉、妄想、混乱或明显行为变化。老人发生幻觉风险更高；这不是羞耻或意志问题，应尽快把变化与完整药单告诉开方团队。", "en": "Caregivers should also watch for gambling, shopping, eating, sexual or other difficult-to-control urges, and for hallucinations, delusions, confusion or marked behavioural change. Hallucination risk is higher in older adults; this is not a moral failing and should be reported promptly with the complete medicine list." }, { "zh": "普拉克索主要经肾脏排泄，肾功能会影响清除。老人或肾功能变化者不能照搬别人的 mg、片数或频次；网页不从年龄、肌酐或估算肾小球滤过率自动生成方案。", "en": "Pramipexole is eliminated mainly by the kidneys, so renal function affects clearance. Older people or those with changing kidney function cannot copy another person's milligrams, tablet count or frequency; the site does not generate a plan from age, creatinine or eGFR." }, { "zh": "与左旋多巴合用时可能加重运动障碍；普通片、ER 缓释片、罗匹尼罗、罗替戈汀贴剂及其他多巴胺相关药不能按共同机制或 mg 自行叠加、轮换或替换。多巴胺拮抗药也可能影响作用，应让药师核对完整药单。", "en": "Levodopa co-use can worsen dyskinesia. Immediate-release and ER pramipexole, ropinirole, rotigotine patches and other dopaminergic medicines cannot be self-combined, rotated or substituted by shared mechanism or milligrams. Dopamine antagonists may also affect response, so a pharmacist should review the full list." }, { "zh": "说明书列出停药相关症状并要求专业渐减；突然停药或快速减量可能出现发热、意识改变、肌强直、焦虑、抑郁、疲劳、疼痛、失眠等。不要按网页自行停药或照搬减量表。", "en": "The labels describe withdrawal symptoms and clinician-directed gradual discontinuation. Abrupt stopping or rapid reduction can be associated with fever, altered consciousness, rigidity, anxiety, depression, fatigue, pain, insomnia and other symptoms. Do not self-stop or copy a taper from the page." } ], "source": { "id": "src_762310eefa903362", "label": "DailyMed（NLM）：盐酸普拉克索普通片当前美国通用名标签（2026-03-31 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=60167d7c-469f-455a-a113-561841af5e59&version=22", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-06", "reviewedAt": "2026-09-06" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "普拉克索怎样起作用：作用于多巴胺 D2 受体家族，对 D3 亲和力较高", "en": "How pramipexole works: a dopamine D2-family agonist with higher affinity for D3" }, "summary": { "zh": "FDA 标签将普拉克索描述为非麦角类多巴胺受体激动剂，对 D2 受体家族具有较高选择性，并对 D3 的亲和力高于 D2 或 D4。帕金森病中的精确作用机制仍未完全确定；机制不能替代诊断、疗效评估或个人用药决定。", "en": "The FDA label describes pramipexole as a non-ergot dopamine-receptor agonist selective for the D2 family, with higher affinity for D3 than D2 or D4. Its precise mechanism in Parkinson's disease remains incompletely defined. Mechanism cannot replace diagnosis, benefit assessment or an individual treatment decision." }, "checks": [ { "zh": "多巴胺作用相近不等于药物相同。普拉克索不能与左旋多巴／卡比多巴、罗匹尼罗、罗替戈汀、阿扑吗啡或其他帕金森病药按 mg 自行换算、叠加或轮换。", "en": "Related dopamine action does not make medicines identical. Pramipexole cannot be self-converted, combined or rotated by milligrams with levodopa/carbidopa, ropinirole, rotigotine, apomorphine or another Parkinson's medicine." }, { "zh": "普通片和 ER 缓释片含共同成分，但释放结构不同。即使历史标签含专业转换说明，也不构成按总 mg 自行换剂型、掰片或改变频次的许可；ER 片应整片吞服。", "en": "Immediate-release and ER tablets share an ingredient but differ in release structure. Even when a historical label includes clinician-directed conversion information, it does not permit self-switching by total milligrams, splitting or changing frequency; ER tablets are swallowed whole." }, { "zh": "无须把“作用于 D3”理解为需要做全基因组筛查。当前标签并未把全基因筛查作为所有人使用前的常规要求；肾功能、症状、耐受性和完整药单更需要针对实际问题核对。", "en": "D3 activity does not imply a need for whole-genome screening. The current label does not make whole-genome screening a routine prerequisite for everyone; kidney function, symptoms, tolerability and the complete medicine list require review for the actual question." } ], "source": { "id": "src_3204a292a1e803fe", "label": "FDA：MIRAPEX 盐酸普拉克索普通片处方信息（NDA 020667；2021-07 版本）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020667s044lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_regulatory_document", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-06", "reviewedAt": "2026-09-06" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "MIRAPEX / MIRAPEX ER", "generic": "盐酸普拉克索", "dosageFormClass": "MIRAPEX 口服普通片历史规格为 0.125、0.25、0.5、0.75、1、1.25、1.5 mg；MIRAPEX ER 口服缓释片为 0.375、0.75、1.5、2.25、3、3.75、4.5 mg。普通片与缓释片的释放、标签用途和使用路径不同，不能只按总 mg 自行换算、拼接、掰分、轮换或替换。" }, "labelSource": { "id": "src_762310eefa903362", "label": "DailyMed（NLM）：盐酸普拉克索普通片当前美国通用名标签（2026-03-31 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=60167d7c-469f-455a-a113-561841af5e59&version=22", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-06", "reviewedAt": "2026-09-06" }, "productRoutes": [ { "source": { "id": "src_762310eefa903362", "label": "DailyMed（NLM）：盐酸普拉克索普通片当前美国通用名标签（2026-03-31 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=60167d7c-469f-455a-a113-561841af5e59&version=22", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-06", "reviewedAt": "2026-09-06" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-09-06", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_3204a292a1e803fe", "label": "FDA：MIRAPEX 盐酸普拉克索普通片处方信息（NDA 020667；2021-07 版本）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020667s044lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_regulatory_document", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-06", "reviewedAt": "2026-09-06" }, "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-09-06", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_023f34bc5fd4ce38", "label": "FDA：MIRAPEX ER 盐酸普拉克索缓释片处方信息（NDA 022421；2021-07 版本）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022421s022lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_regulatory_document", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-06", "reviewedAt": "2026-09-06" }, "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-09-06", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_3d17358ce65b1cf8", "label": "FDA Orange Book 第 46 版（2026）：MIRAPEX NDA 020667 与 MIRAPEX ER NDA 022421 的规格、RLD 与停止销售状态", "url": "https://www.fda.gov/media/71474/download", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-09-02", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-09-06", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "MIRAPEX／MIRAPEX ER 是盐酸普拉克索的历史美国品牌。药盒上的 mg 表示每片标签含量，不是每天片数；普通片与 ER 缓释片不能仅凭共同成分和总毫克数自行互换。老人尤其要先看突然入睡、体位性低血压、幻觉、冲动控制、跌倒与肾功能；与左旋多巴或其他多巴胺相关药同处药单时，不能根据网页自行叠加、减量、停药或错开。", "history": "FDA Orange Book 记录 MIRAPEX 普通片 NDA 020667 于 1997-07-01 获批，0.5 mg 于 1998 年、0.75 mg 于 2007 年形成后续规格；MIRAPEX ER NDA 022421 的首批缓释规格于 2010-02-19 获批，2.25 mg 与 3.75 mg 于 2011-06-17 获批。品牌记录目前均列为停止销售，因此本页把历史品牌身份、当前通用名标签和实时供应严格分开。", "sourceDocuments": [ { "id": "src_762310eefa903362", "label": "DailyMed（NLM）：盐酸普拉克索普通片当前美国通用名标签（2026-03-31 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=60167d7c-469f-455a-a113-561841af5e59&version=22", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-06", "reviewedAt": "2026-09-06" }, { "id": "src_3204a292a1e803fe", "label": "FDA：MIRAPEX 盐酸普拉克索普通片处方信息（NDA 020667；2021-07 版本）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020667s044lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_regulatory_document", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-06", "reviewedAt": "2026-09-06" }, { "id": "src_023f34bc5fd4ce38", "label": "FDA：MIRAPEX ER 盐酸普拉克索缓释片处方信息（NDA 022421；2021-07 版本）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022421s022lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_regulatory_document", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-06", "reviewedAt": "2026-09-06" }, { "id": "src_822acc19cb7aac1d", "label": "FDA：MIRAPEX 普通片 0.25 mg、NDC 0597-0184-61、100 片历史纸盒标签（2020 批准文件）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020667Orig1s039lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_regulatory_record", "documentKind": "carton_and_container_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-06", "reviewedAt": "2026-09-06" }, { "id": "src_3d17358ce65b1cf8", "label": "FDA Orange Book 第 46 版（2026）：MIRAPEX NDA 020667 与 MIRAPEX ER NDA 022421 的规格、RLD 与停止销售状态", "url": "https://www.fda.gov/media/71474/download", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" } ], "applicationNumber": "MIRAPEX NDA 020667；MIRAPEX ER NDA 022421", "approvalTimeline": [ { "date": "1997-07-01", "title": { "zh": "MIRAPEX 普通片在美国首次批准", "en": "Initial U.S. approval of MIRAPEX immediate-release tablets" }, "detail": { "zh": "Orange Book 将 0.125、0.25、1、1.25 与 1.5 mg 的最初批准日期列为 1997-07-01，并将多个规格保留为历史 RLD。", "en": "The Orange Book lists 1 July 1997 for the initial 0.125, 0.25, 1, 1.25 and 1.5 mg approvals and retains several strengths as historical RLD products." }, "source": { "id": "src_3d17358ce65b1cf8", "label": "FDA Orange Book 第 46 版（2026）：MIRAPEX NDA 020667 与 MIRAPEX ER NDA 022421 的规格、RLD 与停止销售状态", "url": "https://www.fda.gov/media/71474/download", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" } }, { "date": "2010-02-19", "title": { "zh": "MIRAPEX ER 缓释片在美国批准", "en": "U.S. approval of MIRAPEX ER" }, "detail": { "zh": "NDA 022421 的 0.375、0.75、1.5、3 与 4.5 mg 缓释片于该日批准；2.25 与 3.75 mg 后于 2011 年批准。", "en": "The 0.375, 0.75, 1.5, 3 and 4.5 mg ER tablets under NDA 022421 were approved on this date; 2.25 and 3.75 mg followed in 2011." }, "source": { "id": "src_3d17358ce65b1cf8", "label": "FDA Orange Book 第 46 版（2026）：MIRAPEX NDA 020667 与 MIRAPEX ER NDA 022421 的规格、RLD 与停止销售状态", "url": "https://www.fda.gov/media/71474/download", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" } }, { "date": "2021-07", "title": { "zh": "FDA 更新普通片与 ER 的行为、幻觉和停药警示", "en": "FDA updated behavioural, hallucination and withdrawal warnings for IR and ER" }, "detail": { "zh": "两份标签均保留突然入睡、体位性低血压、冲动控制与幻觉，并新增或强化停药相关警示。", "en": "Both labels retain sudden-sleep, orthostatic-hypotension, impulse-control and hallucination warnings and add or strengthen withdrawal information." }, "source": { "id": "src_3204a292a1e803fe", "label": "FDA：MIRAPEX 盐酸普拉克索普通片处方信息（NDA 020667；2021-07 版本）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020667s044lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_regulatory_document", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-06", "reviewedAt": "2026-09-06" } }, { "date": "2026-03-31", "title": { "zh": "当前美国通用名标签更新", "en": "Current U.S. generic label updated" }, "detail": { "zh": "当前 DailyMed 普通片标签用于补充现行安全阅读，不替代历史 MIRAPEX 品牌身份。", "en": "The current DailyMed immediate-release generic label supplies current safety reading without replacing historical MIRAPEX brand identity." }, "source": { "id": "src_762310eefa903362", "label": "DailyMed（NLM）：盐酸普拉克索普通片当前美国通用名标签（2026-03-31 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=60167d7c-469f-455a-a113-561841af5e59&version=22", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-06", "reviewedAt": "2026-09-06" } } ], "marketStatus": [ { "market": { "zh": "美国 MIRAPEX 普通片", "en": "United States — MIRAPEX immediate-release" }, "status": { "zh": "历史原研/RLD，当前品牌行停止销售", "en": "Historical originator/RLD; brand rows currently discontinued" }, "detail": { "zh": "七个规格均为历史品牌记录；仍可访问的标签和纸盒文件不证明当前品牌库存。", "en": "All seven strengths are historical brand records. Accessible labels and carton documents do not establish current brand stock." } }, { "market": { "zh": "美国 MIRAPEX ER", "en": "United States — MIRAPEX ER" }, "status": { "zh": "历史缓释片 RLD，当前品牌行停止销售", "en": "Historical ER RLD; brand rows currently discontinued" }, "detail": { "zh": "七个缓释规格属于独立 NDA 022421；不能与普通片按名称或总 mg 自动合并。", "en": "Seven ER strengths belong to separate NDA 022421 and cannot be automatically merged with immediate-release tablets by name or total milligrams." } }, { "market": { "zh": "中国大陆、欧盟、日本及其他市场", "en": "Mainland China, EU, Japan and other markets" }, "status": { "zh": "准确市场产品记录待逐项建立", "en": "Exact market-product records not yet established" }, "detail": { "zh": "不从美国 NDA、历史商品名、规格或共同通用名推定当地批准、包装、供应、原研/仿制关系或可替代性。", "en": "No local approval, pack, supply, originator/generic relationship or interchangeability is inferred from U.S. NDAs, historical trade names, strengths or a shared generic name." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "0.25 mg 是一天吃两片 0.125 mg 吗？", "en": "Does 0.25 mg mean two 0.125 mg tablets per day?" }, "answer": { "zh": "网页不能这样换算。mg 是每片标签含量；个人片数、频次、普通片或 ER 剂型必须依据准确处方、适应证、肾功能、症状和完整药单由专业人员确认。", "en": "The page cannot make that conversion. Milligrams are the labelled amount per tablet; individual tablet count, frequency and IR/ER form require professional confirmation from the exact prescription, indication, kidney function, symptoms and full medicine list." } }, { "question": { "zh": "普通片可以换成同总 mg 的 MIRAPEX ER 吗？", "en": "Can immediate-release tablets be switched to the same total milligrams of MIRAPEX ER?" }, "answer": { "zh": "不能由网页授权。两者释放结构、标签用途和使用路径不同；历史说明书里的专业转换内容也不是患者自行换剂型的许可。", "en": "A webpage cannot authorise this. Release structure, labelled use and administration pathway differ. Clinician-directed conversion content in a historical label is not permission to self-switch formulations." } }, { "question": { "zh": "出现幻觉、突然入睡或异常冲动怎么办？", "en": "What if hallucinations, sudden sleep or unusual urges occur?" }, "answer": { "zh": "停止驾驶和其他危险活动，尽快联系开方团队，并让照护者一同说明变化和完整药单。严重意识异常、事故、跌倒受伤或其他急性危险应使用当地急救；不要自行突然停药。", "en": "Stop driving and other hazardous activities, contact the prescribing team promptly, and have a caregiver describe changes and the full medicine list. Severe altered awareness, an accident, fall injury or another acute danger requires local emergency help; do not abruptly stop the medicine yourself." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "dosage-forms-are-part-of-medicine-identity", "how-to-read-a-drug-label", "medicine-list-review-for-older-adults" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/mirapex-pramipexole/", "en": "https://origindrug.com/en/drugs/mirapex-pramipexole/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "duoplavin-clopidogrel-aspirin", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-09-06", "status": "published_traceable_archive" }, "names": { "brand": "DuoPlavin", "generic": "氯吡格雷／乙酰水杨酸（阿司匹林）", "aliases": [ "DUOPLAVIN", "Duo Plavin", "clopidogrel acetylsalicylic acid", "clopidogrel aspirin", "clopidogrel/aspirin", "氯吡格雷阿司匹林", "氯吡格雷/阿司匹林", "氯吡格雷乙酰水杨酸", "氯吡格雷阿司匹林片" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "抗凝与血液", "sourceArchiveMarket": "欧盟：DuoPlavin EMEA/H/C/001143 当前集中授权档案、2026-06-11 更新的产品资料、两种强度及 15 个授权包装号。EMA 明确并非所有包装规格都一定上市，因此这些记录不代表实时库存、价格、购买资格或任一成员国当前供应。中国大陆、美国、日本及其他市场须另查当地现行记录。", "dosageFormClass": "DuoPlavin 薄膜衣片把氯吡格雷 75 mg 与阿司匹林 75 mg 或 100 mg 放在同一片内。两个数字分属两种有效成分，不是 150 mg 或 175 mg 的单一药；本页不从椭圆外形推导可掰片。", "dosageFormClassCode": "oral_solid", "route": "口服（固定两成分产品身份字段）", "routeCode": "oral", "historicalApprovalEntry": "2010（欧盟集中授权）", "archiveSponsorText": "Sanofi Winthrop Industrie（EMA 当前上市许可持有人）" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [ "DuoPlavin 75 mg/75 mg", "DuoPlavin 75 mg/100 mg", "clopidogrel/acetylsalicylic acid film-coated tablets", "氯吡格雷阿司匹林片" ], "excludedProductCues": [ "PLAVIX", "clopidogrel alone", "单方氯吡格雷", "aspirin alone", "单方阿司匹林", "Bayer Aspirin", "AGGRENOX", "dipyridamole", "DuoCover", "EMEA/H/C/000874" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "eu-duoplavin-clopidogrel-75mg-aspirin-75mg-14-tablet-eu-1-10-619-001", "marketCode": "EU", "labelVersion": { "zh": "EMA 当前欧盟产品资料（2026-06-11 更新）", "en": "Current EMA EU product information (updated 11 Jun 2026)" }, "dosageForm": { "zh": "DuoPlavin 氯吡格雷 75 mg／阿司匹林 75 mg 薄膜衣片", "en": "DuoPlavin clopidogrel 75 mg/aspirin 75 mg film-coated tablet" }, "route": { "zh": "口服（固定两成分产品身份字段）", "en": "oral (fixed two-ingredient product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "EU/1/10/619/001", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片氯吡格雷 75 mg＋阿司匹林 75 mg；14 片泡罩纸盒；不是一种 150 mg 药物", "en": "Clopidogrel 75 mg plus aspirin 75 mg per tablet; 14-tablet blister carton; not one 150 mg medicine" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "氯吡格雷（以硫酸氢盐计）", "en": "clopidogrel (as hydrogen sulphate)" }, "value": 75, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "同一片中的氯吡格雷标示量；不是个人片数或频率", "en": "labelled clopidogrel amount in the same tablet; not an individual's tablet count or frequency" } }, { "ingredient": { "zh": "乙酰水杨酸（阿司匹林，ASA）", "en": "acetylsalicylic acid (aspirin, ASA)" }, "value": 75, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "同一片中的阿司匹林标示量；不是另一片药或个人用法", "en": "labelled aspirin amount in the same tablet; not a second tablet or an individual's regimen" } } ], "concentration": null, "container": { "typeCode": "blister_carton", "typeLabel": { "zh": "全铝泡罩纸盒", "en": "all-aluminium blister carton" }, "fill": null, "countPerPackage": 14, "countUnit": { "zh": "片/包装", "en": "tablets per pack" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-06", "currentLabelDisplayed": true, "ndcDirectoryListed": false, "marketAvailability": "current_eu_authorisation_pack_record_not_live_inventory", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 14, "unit": { "zh": "片/包装", "en": "tablets per pack" } }, "physicalClues": { "color": { "zh": "黄色", "en": "yellow" }, "shape": { "zh": "椭圆形、轻微双凸薄膜衣片；外观线索不等于真伪鉴定", "en": "oval, slightly biconvex film-coated tablet; appearance is not authentication" }, "imprint": "C75 / A75", "scoreStatus": "no_source_backed_split_permission", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_e2d29127841a1da3", "label": "EMA：DuoPlavin 当前欧盟产品资料与电子说明书（75 mg/75 mg、75 mg/100 mg；2026-06-11 更新）", "url": "https://www.ema.europa.eu/en/documents/product-information/duoplavin-epar-product-information_en.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-06", "reviewedAt": "2026-09-06" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "eu-duoplavin-clopidogrel-75mg-aspirin-75mg-28-tablet-eu-1-10-619-002", "marketCode": "EU", "labelVersion": { "zh": "EMA 当前欧盟产品资料（2026-06-11 更新）", "en": "Current EMA EU product information (updated 11 Jun 2026)" }, "dosageForm": { "zh": "DuoPlavin 氯吡格雷 75 mg／阿司匹林 75 mg 薄膜衣片", "en": "DuoPlavin clopidogrel 75 mg/aspirin 75 mg film-coated tablet" }, "route": { "zh": "口服（固定两成分产品身份字段）", "en": "oral (fixed two-ingredient product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "EU/1/10/619/002", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片氯吡格雷 75 mg＋阿司匹林 75 mg；28 片泡罩纸盒；不是一种 150 mg 药物", "en": "Clopidogrel 75 mg plus aspirin 75 mg per tablet; 28-tablet blister carton; not one 150 mg medicine" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "氯吡格雷（以硫酸氢盐计）", "en": "clopidogrel (as hydrogen sulphate)" }, "value": 75, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "同一片中的氯吡格雷标示量；不是个人片数或频率", "en": "labelled clopidogrel amount in the same tablet; not an individual's tablet count or frequency" } }, { "ingredient": { "zh": "乙酰水杨酸（阿司匹林，ASA）", "en": "acetylsalicylic acid (aspirin, ASA)" }, "value": 75, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "同一片中的阿司匹林标示量；不是另一片药或个人用法", "en": "labelled aspirin amount in the same tablet; not a second tablet or an individual's regimen" } } ], "concentration": null, "container": { "typeCode": "blister_carton", "typeLabel": { "zh": "全铝泡罩纸盒", "en": "all-aluminium blister carton" }, "fill": null, "countPerPackage": 28, "countUnit": { "zh": "片/包装", "en": "tablets per pack" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-06", "currentLabelDisplayed": true, "ndcDirectoryListed": false, "marketAvailability": "current_eu_authorisation_pack_record_not_live_inventory", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 28, "unit": { "zh": "片/包装", "en": "tablets per pack" } }, "physicalClues": { "color": { "zh": "黄色", "en": "yellow" }, "shape": { "zh": "椭圆形、轻微双凸薄膜衣片；外观线索不等于真伪鉴定", "en": "oval, slightly biconvex film-coated tablet; appearance is not authentication" }, "imprint": "C75 / A75", "scoreStatus": "no_source_backed_split_permission", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_e2d29127841a1da3", "label": "EMA：DuoPlavin 当前欧盟产品资料与电子说明书（75 mg/75 mg、75 mg/100 mg；2026-06-11 更新）", "url": "https://www.ema.europa.eu/en/documents/product-information/duoplavin-epar-product-information_en.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-06", "reviewedAt": "2026-09-06" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "eu-duoplavin-clopidogrel-75mg-aspirin-75mg-30x1-tablet-eu-1-10-619-003", "marketCode": "EU", "labelVersion": { "zh": "EMA 当前欧盟产品资料（2026-06-11 更新）", "en": "Current EMA EU product information (updated 11 Jun 2026)" }, "dosageForm": { "zh": "DuoPlavin 氯吡格雷 75 mg／阿司匹林 75 mg 薄膜衣片", "en": "DuoPlavin clopidogrel 75 mg/aspirin 75 mg film-coated tablet" }, "route": { "zh": "口服（固定两成分产品身份字段）", "en": "oral (fixed two-ingredient product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "EU/1/10/619/003", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片氯吡格雷 75 mg＋阿司匹林 75 mg；30 × 1 片单位剂量泡罩纸盒；不是一种 150 mg 药物", "en": "Clopidogrel 75 mg plus aspirin 75 mg per tablet; 30 × 1-tablet unit-dose blister carton; not one 150 mg medicine" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "氯吡格雷（以硫酸氢盐计）", "en": "clopidogrel (as hydrogen sulphate)" }, "value": 75, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "同一片中的氯吡格雷标示量；不是个人片数或频率", "en": "labelled clopidogrel amount in the same tablet; not an individual's tablet count or frequency" } }, { "ingredient": { "zh": "乙酰水杨酸（阿司匹林，ASA）", "en": "acetylsalicylic acid (aspirin, ASA)" }, "value": 75, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "同一片中的阿司匹林标示量；不是另一片药或个人用法", "en": "labelled aspirin amount in the same tablet; not a second tablet or an individual's regimen" } } ], "concentration": null, "container": { "typeCode": "unit_dose_blister_carton", "typeLabel": { "zh": "全铝单位剂量泡罩纸盒", "en": "all-aluminium unit-dose blister carton" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "片/包装", "en": "tablets per pack" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-06", "currentLabelDisplayed": true, "ndcDirectoryListed": false, "marketAvailability": "current_eu_authorisation_pack_record_not_live_inventory", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 30, "unit": { "zh": "片/包装", "en": "tablets per pack" } }, "physicalClues": { "color": { "zh": "黄色", "en": "yellow" }, "shape": { "zh": "椭圆形、轻微双凸薄膜衣片；外观线索不等于真伪鉴定", "en": "oval, slightly biconvex film-coated tablet; appearance is not authentication" }, "imprint": "C75 / A75", "scoreStatus": "no_source_backed_split_permission", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_e2d29127841a1da3", "label": "EMA：DuoPlavin 当前欧盟产品资料与电子说明书（75 mg/75 mg、75 mg/100 mg；2026-06-11 更新）", "url": "https://www.ema.europa.eu/en/documents/product-information/duoplavin-epar-product-information_en.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-06", "reviewedAt": "2026-09-06" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "eu-duoplavin-clopidogrel-75mg-aspirin-75mg-50x1-tablet-eu-1-10-619-004", "marketCode": "EU", "labelVersion": { "zh": "EMA 当前欧盟产品资料（2026-06-11 更新）", "en": "Current EMA EU product information (updated 11 Jun 2026)" }, "dosageForm": { "zh": "DuoPlavin 氯吡格雷 75 mg／阿司匹林 75 mg 薄膜衣片", "en": "DuoPlavin clopidogrel 75 mg/aspirin 75 mg film-coated tablet" }, "route": { "zh": "口服（固定两成分产品身份字段）", "en": "oral (fixed two-ingredient product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "EU/1/10/619/004", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片氯吡格雷 75 mg＋阿司匹林 75 mg；50 × 1 片单位剂量泡罩纸盒；不是一种 150 mg 药物", "en": "Clopidogrel 75 mg plus aspirin 75 mg per tablet; 50 × 1-tablet unit-dose blister carton; not one 150 mg medicine" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "氯吡格雷（以硫酸氢盐计）", "en": "clopidogrel (as hydrogen sulphate)" }, "value": 75, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "同一片中的氯吡格雷标示量；不是个人片数或频率", "en": "labelled clopidogrel amount in the same tablet; not an individual's tablet count or frequency" } }, { "ingredient": { "zh": "乙酰水杨酸（阿司匹林，ASA）", "en": "acetylsalicylic acid (aspirin, ASA)" }, "value": 75, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "同一片中的阿司匹林标示量；不是另一片药或个人用法", "en": "labelled aspirin amount in the same tablet; not a second tablet or an individual's regimen" } } ], "concentration": null, "container": { "typeCode": "unit_dose_blister_carton", "typeLabel": { "zh": "全铝单位剂量泡罩纸盒", "en": "all-aluminium unit-dose blister carton" }, "fill": null, "countPerPackage": 50, "countUnit": { "zh": "片/包装", "en": "tablets per pack" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-06", "currentLabelDisplayed": true, "ndcDirectoryListed": false, "marketAvailability": "current_eu_authorisation_pack_record_not_live_inventory", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 50, "unit": { "zh": "片/包装", "en": "tablets per pack" } }, "physicalClues": { "color": { "zh": "黄色", "en": "yellow" }, "shape": { "zh": "椭圆形、轻微双凸薄膜衣片；外观线索不等于真伪鉴定", "en": "oval, slightly biconvex film-coated tablet; appearance is not authentication" }, "imprint": "C75 / A75", "scoreStatus": "no_source_backed_split_permission", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_e2d29127841a1da3", "label": "EMA：DuoPlavin 当前欧盟产品资料与电子说明书（75 mg/75 mg、75 mg/100 mg；2026-06-11 更新）", "url": "https://www.ema.europa.eu/en/documents/product-information/duoplavin-epar-product-information_en.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-06", "reviewedAt": "2026-09-06" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "eu-duoplavin-clopidogrel-75mg-aspirin-75mg-84-tablet-eu-1-10-619-005", "marketCode": "EU", "labelVersion": { "zh": "EMA 当前欧盟产品资料（2026-06-11 更新）", "en": "Current EMA EU product information (updated 11 Jun 2026)" }, "dosageForm": { "zh": "DuoPlavin 氯吡格雷 75 mg／阿司匹林 75 mg 薄膜衣片", "en": "DuoPlavin clopidogrel 75 mg/aspirin 75 mg film-coated tablet" }, "route": { "zh": "口服（固定两成分产品身份字段）", "en": "oral (fixed two-ingredient product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "EU/1/10/619/005", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片氯吡格雷 75 mg＋阿司匹林 75 mg；84 片泡罩纸盒；不是一种 150 mg 药物", "en": "Clopidogrel 75 mg plus aspirin 75 mg per tablet; 84-tablet blister carton; not one 150 mg medicine" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "氯吡格雷（以硫酸氢盐计）", "en": "clopidogrel (as hydrogen sulphate)" }, "value": 75, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "同一片中的氯吡格雷标示量；不是个人片数或频率", "en": "labelled clopidogrel amount in the same tablet; not an individual's tablet count or frequency" } }, { "ingredient": { "zh": "乙酰水杨酸（阿司匹林，ASA）", "en": "acetylsalicylic acid (aspirin, ASA)" }, "value": 75, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "同一片中的阿司匹林标示量；不是另一片药或个人用法", "en": "labelled aspirin amount in the same tablet; not a second tablet or an individual's regimen" } } ], "concentration": null, "container": { "typeCode": "blister_carton", "typeLabel": { "zh": "全铝泡罩纸盒", "en": "all-aluminium blister carton" }, "fill": null, "countPerPackage": 84, "countUnit": { "zh": "片/包装", "en": "tablets per pack" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-06", "currentLabelDisplayed": true, "ndcDirectoryListed": false, "marketAvailability": "current_eu_authorisation_pack_record_not_live_inventory", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 84, "unit": { "zh": "片/包装", "en": "tablets per pack" } }, "physicalClues": { "color": { "zh": "黄色", "en": "yellow" }, "shape": { "zh": "椭圆形、轻微双凸薄膜衣片；外观线索不等于真伪鉴定", "en": "oval, slightly biconvex film-coated tablet; appearance is not authentication" }, "imprint": "C75 / A75", "scoreStatus": "no_source_backed_split_permission", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_e2d29127841a1da3", "label": "EMA：DuoPlavin 当前欧盟产品资料与电子说明书（75 mg/75 mg、75 mg/100 mg；2026-06-11 更新）", "url": "https://www.ema.europa.eu/en/documents/product-information/duoplavin-epar-product-information_en.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-06", "reviewedAt": "2026-09-06" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "eu-duoplavin-clopidogrel-75mg-aspirin-75mg-90x1-tablet-eu-1-10-619-006", "marketCode": "EU", "labelVersion": { "zh": "EMA 当前欧盟产品资料（2026-06-11 更新）", "en": "Current EMA EU product information (updated 11 Jun 2026)" }, "dosageForm": { "zh": "DuoPlavin 氯吡格雷 75 mg／阿司匹林 75 mg 薄膜衣片", "en": "DuoPlavin clopidogrel 75 mg/aspirin 75 mg film-coated tablet" }, "route": { "zh": "口服（固定两成分产品身份字段）", "en": "oral (fixed two-ingredient product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "EU/1/10/619/006", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片氯吡格雷 75 mg＋阿司匹林 75 mg；90 × 1 片单位剂量泡罩纸盒；不是一种 150 mg 药物", "en": "Clopidogrel 75 mg plus aspirin 75 mg per tablet; 90 × 1-tablet unit-dose blister carton; not one 150 mg medicine" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "氯吡格雷（以硫酸氢盐计）", "en": "clopidogrel (as hydrogen sulphate)" }, "value": 75, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "同一片中的氯吡格雷标示量；不是个人片数或频率", "en": "labelled clopidogrel amount in the same tablet; not an individual's tablet count or frequency" } }, { "ingredient": { "zh": "乙酰水杨酸（阿司匹林，ASA）", "en": "acetylsalicylic acid (aspirin, ASA)" }, "value": 75, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "同一片中的阿司匹林标示量；不是另一片药或个人用法", "en": "labelled aspirin amount in the same tablet; not a second tablet or an individual's regimen" } } ], "concentration": null, "container": { "typeCode": "unit_dose_blister_carton", "typeLabel": { "zh": "全铝单位剂量泡罩纸盒", "en": "all-aluminium unit-dose blister carton" }, "fill": null, "countPerPackage": 90, "countUnit": { "zh": "片/包装", "en": "tablets per pack" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-06", "currentLabelDisplayed": true, "ndcDirectoryListed": false, "marketAvailability": "current_eu_authorisation_pack_record_not_live_inventory", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 90, "unit": { "zh": "片/包装", "en": "tablets per pack" } }, "physicalClues": { "color": { "zh": "黄色", "en": "yellow" }, "shape": { "zh": "椭圆形、轻微双凸薄膜衣片；外观线索不等于真伪鉴定", "en": "oval, slightly biconvex film-coated tablet; appearance is not authentication" }, "imprint": "C75 / A75", "scoreStatus": "no_source_backed_split_permission", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_e2d29127841a1da3", "label": "EMA：DuoPlavin 当前欧盟产品资料与电子说明书（75 mg/75 mg、75 mg/100 mg；2026-06-11 更新）", "url": "https://www.ema.europa.eu/en/documents/product-information/duoplavin-epar-product-information_en.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-06", "reviewedAt": "2026-09-06" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "eu-duoplavin-clopidogrel-75mg-aspirin-75mg-100x1-tablet-eu-1-10-619-007", "marketCode": "EU", "labelVersion": { "zh": "EMA 当前欧盟产品资料（2026-06-11 更新）", "en": "Current EMA EU product information (updated 11 Jun 2026)" }, "dosageForm": { "zh": "DuoPlavin 氯吡格雷 75 mg／阿司匹林 75 mg 薄膜衣片", "en": "DuoPlavin clopidogrel 75 mg/aspirin 75 mg film-coated tablet" }, "route": { "zh": "口服（固定两成分产品身份字段）", "en": "oral (fixed two-ingredient product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "EU/1/10/619/007", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片氯吡格雷 75 mg＋阿司匹林 75 mg；100 × 1 片单位剂量泡罩纸盒；不是一种 150 mg 药物", "en": "Clopidogrel 75 mg plus aspirin 75 mg per tablet; 100 × 1-tablet unit-dose blister carton; not one 150 mg medicine" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "氯吡格雷（以硫酸氢盐计）", "en": "clopidogrel (as hydrogen sulphate)" }, "value": 75, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "同一片中的氯吡格雷标示量；不是个人片数或频率", "en": "labelled clopidogrel amount in the same tablet; not an individual's tablet count or frequency" } }, { "ingredient": { "zh": "乙酰水杨酸（阿司匹林，ASA）", "en": "acetylsalicylic acid (aspirin, ASA)" }, "value": 75, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "同一片中的阿司匹林标示量；不是另一片药或个人用法", "en": "labelled aspirin amount in the same tablet; not a second tablet or an individual's regimen" } } ], "concentration": null, "container": { "typeCode": "unit_dose_blister_carton", "typeLabel": { "zh": "全铝单位剂量泡罩纸盒", "en": "all-aluminium unit-dose blister carton" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "片/包装", "en": "tablets per pack" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-06", "currentLabelDisplayed": true, "ndcDirectoryListed": false, "marketAvailability": "current_eu_authorisation_pack_record_not_live_inventory", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "片/包装", "en": "tablets per pack" } }, "physicalClues": { "color": { "zh": "黄色", "en": "yellow" }, "shape": { "zh": "椭圆形、轻微双凸薄膜衣片；外观线索不等于真伪鉴定", "en": "oval, slightly biconvex film-coated tablet; appearance is not authentication" }, "imprint": "C75 / A75", "scoreStatus": "no_source_backed_split_permission", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_e2d29127841a1da3", "label": "EMA：DuoPlavin 当前欧盟产品资料与电子说明书（75 mg/75 mg、75 mg/100 mg；2026-06-11 更新）", "url": "https://www.ema.europa.eu/en/documents/product-information/duoplavin-epar-product-information_en.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-06", "reviewedAt": "2026-09-06" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "eu-duoplavin-clopidogrel-75mg-aspirin-75mg-30-tablet-eu-1-10-619-015", "marketCode": "EU", "labelVersion": { "zh": "EMA 当前欧盟产品资料（2026-06-11 更新）", "en": "Current EMA EU product information (updated 11 Jun 2026)" }, "dosageForm": { "zh": "DuoPlavin 氯吡格雷 75 mg／阿司匹林 75 mg 薄膜衣片", "en": "DuoPlavin clopidogrel 75 mg/aspirin 75 mg film-coated tablet" }, "route": { "zh": "口服（固定两成分产品身份字段）", "en": "oral (fixed two-ingredient product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "EU/1/10/619/015", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片氯吡格雷 75 mg＋阿司匹林 75 mg；30 片泡罩纸盒；不是一种 150 mg 药物", "en": "Clopidogrel 75 mg plus aspirin 75 mg per tablet; 30-tablet blister carton; not one 150 mg medicine" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "氯吡格雷（以硫酸氢盐计）", "en": "clopidogrel (as hydrogen sulphate)" }, "value": 75, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "同一片中的氯吡格雷标示量；不是个人片数或频率", "en": "labelled clopidogrel amount in the same tablet; not an individual's tablet count or frequency" } }, { "ingredient": { "zh": "乙酰水杨酸（阿司匹林，ASA）", "en": "acetylsalicylic acid (aspirin, ASA)" }, "value": 75, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "同一片中的阿司匹林标示量；不是另一片药或个人用法", "en": "labelled aspirin amount in the same tablet; not a second tablet or an individual's regimen" } } ], "concentration": null, "container": { "typeCode": "blister_carton", "typeLabel": { "zh": "全铝泡罩纸盒", "en": "all-aluminium blister carton" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "片/包装", "en": "tablets per pack" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-06", "currentLabelDisplayed": true, "ndcDirectoryListed": false, "marketAvailability": "current_eu_authorisation_pack_record_not_live_inventory", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 30, "unit": { "zh": "片/包装", "en": "tablets per pack" } }, "physicalClues": { "color": { "zh": "黄色", "en": "yellow" }, "shape": { "zh": "椭圆形、轻微双凸薄膜衣片；外观线索不等于真伪鉴定", "en": "oval, slightly biconvex film-coated tablet; appearance is not authentication" }, "imprint": "C75 / A75", "scoreStatus": "no_source_backed_split_permission", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_e2d29127841a1da3", "label": "EMA：DuoPlavin 当前欧盟产品资料与电子说明书（75 mg/75 mg、75 mg/100 mg；2026-06-11 更新）", "url": "https://www.ema.europa.eu/en/documents/product-information/duoplavin-epar-product-information_en.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-06", "reviewedAt": "2026-09-06" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "eu-duoplavin-clopidogrel-75mg-aspirin-100mg-14-tablet-eu-1-10-619-008", "marketCode": "EU", "labelVersion": { "zh": "EMA 当前欧盟产品资料（2026-06-11 更新）", "en": "Current EMA EU product information (updated 11 Jun 2026)" }, "dosageForm": { "zh": "DuoPlavin 氯吡格雷 75 mg／阿司匹林 100 mg 薄膜衣片", "en": "DuoPlavin clopidogrel 75 mg/aspirin 100 mg film-coated tablet" }, "route": { "zh": "口服（固定两成分产品身份字段）", "en": "oral (fixed two-ingredient product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "EU/1/10/619/008", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片氯吡格雷 75 mg＋阿司匹林 100 mg；14 片泡罩纸盒；不是一种 175 mg 药物", "en": "Clopidogrel 75 mg plus aspirin 100 mg per tablet; 14-tablet blister carton; not one 175 mg medicine" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "氯吡格雷（以硫酸氢盐计）", "en": "clopidogrel (as hydrogen sulphate)" }, "value": 75, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "同一片中的氯吡格雷标示量；不是个人片数或频率", "en": "labelled clopidogrel amount in the same tablet; not an individual's tablet count or frequency" } }, { "ingredient": { "zh": "乙酰水杨酸（阿司匹林，ASA）", "en": "acetylsalicylic acid (aspirin, ASA)" }, "value": 100, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "同一片中的阿司匹林标示量；不是另一片药或个人用法", "en": "labelled aspirin amount in the same tablet; not a second tablet or an individual's regimen" } } ], "concentration": null, "container": { "typeCode": "blister_carton", "typeLabel": { "zh": "全铝泡罩纸盒", "en": "all-aluminium blister carton" }, "fill": null, "countPerPackage": 14, "countUnit": { "zh": "片/包装", "en": "tablets per pack" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-06", "currentLabelDisplayed": true, "ndcDirectoryListed": false, "marketAvailability": "current_eu_authorisation_pack_record_not_live_inventory", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 14, "unit": { "zh": "片/包装", "en": "tablets per pack" } }, "physicalClues": { "color": { "zh": "浅粉色", "en": "light pink" }, "shape": { "zh": "椭圆形、轻微双凸薄膜衣片；外观线索不等于真伪鉴定", "en": "oval, slightly biconvex film-coated tablet; appearance is not authentication" }, "imprint": "C75 / A100", "scoreStatus": "no_source_backed_split_permission", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_e2d29127841a1da3", "label": "EMA：DuoPlavin 当前欧盟产品资料与电子说明书（75 mg/75 mg、75 mg/100 mg；2026-06-11 更新）", "url": "https://www.ema.europa.eu/en/documents/product-information/duoplavin-epar-product-information_en.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-06", "reviewedAt": "2026-09-06" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "eu-duoplavin-clopidogrel-75mg-aspirin-100mg-28-tablet-eu-1-10-619-009", "marketCode": "EU", "labelVersion": { "zh": "EMA 当前欧盟产品资料（2026-06-11 更新）", "en": "Current EMA EU product information (updated 11 Jun 2026)" }, "dosageForm": { "zh": "DuoPlavin 氯吡格雷 75 mg／阿司匹林 100 mg 薄膜衣片", "en": "DuoPlavin clopidogrel 75 mg/aspirin 100 mg film-coated tablet" }, "route": { "zh": "口服（固定两成分产品身份字段）", "en": "oral (fixed two-ingredient product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "EU/1/10/619/009", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片氯吡格雷 75 mg＋阿司匹林 100 mg；28 片泡罩纸盒；不是一种 175 mg 药物", "en": "Clopidogrel 75 mg plus aspirin 100 mg per tablet; 28-tablet blister carton; not one 175 mg medicine" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "氯吡格雷（以硫酸氢盐计）", "en": "clopidogrel (as hydrogen sulphate)" }, "value": 75, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "同一片中的氯吡格雷标示量；不是个人片数或频率", "en": "labelled clopidogrel amount in the same tablet; not an individual's tablet count or frequency" } }, { "ingredient": { "zh": "乙酰水杨酸（阿司匹林，ASA）", "en": "acetylsalicylic acid (aspirin, ASA)" }, "value": 100, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "同一片中的阿司匹林标示量；不是另一片药或个人用法", "en": "labelled aspirin amount in the same tablet; not a second tablet or an individual's regimen" } } ], "concentration": null, "container": { "typeCode": "blister_carton", "typeLabel": { "zh": "全铝泡罩纸盒", "en": "all-aluminium blister carton" }, "fill": null, "countPerPackage": 28, "countUnit": { "zh": "片/包装", "en": "tablets per pack" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-06", "currentLabelDisplayed": true, "ndcDirectoryListed": false, "marketAvailability": "current_eu_authorisation_pack_record_not_live_inventory", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 28, "unit": { "zh": "片/包装", "en": "tablets per pack" } }, "physicalClues": { "color": { "zh": "浅粉色", "en": "light pink" }, "shape": { "zh": "椭圆形、轻微双凸薄膜衣片；外观线索不等于真伪鉴定", "en": "oval, slightly biconvex film-coated tablet; appearance is not authentication" }, "imprint": "C75 / A100", "scoreStatus": "no_source_backed_split_permission", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_e2d29127841a1da3", "label": "EMA：DuoPlavin 当前欧盟产品资料与电子说明书（75 mg/75 mg、75 mg/100 mg；2026-06-11 更新）", "url": "https://www.ema.europa.eu/en/documents/product-information/duoplavin-epar-product-information_en.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-06", "reviewedAt": "2026-09-06" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "eu-duoplavin-clopidogrel-75mg-aspirin-100mg-30x1-tablet-eu-1-10-619-010", "marketCode": "EU", "labelVersion": { "zh": "EMA 当前欧盟产品资料（2026-06-11 更新）", "en": "Current EMA EU product information (updated 11 Jun 2026)" }, "dosageForm": { "zh": "DuoPlavin 氯吡格雷 75 mg／阿司匹林 100 mg 薄膜衣片", "en": "DuoPlavin clopidogrel 75 mg/aspirin 100 mg film-coated tablet" }, "route": { "zh": "口服（固定两成分产品身份字段）", "en": "oral (fixed two-ingredient product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "EU/1/10/619/010", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片氯吡格雷 75 mg＋阿司匹林 100 mg；30 × 1 片单位剂量泡罩纸盒；不是一种 175 mg 药物", "en": "Clopidogrel 75 mg plus aspirin 100 mg per tablet; 30 × 1-tablet unit-dose blister carton; not one 175 mg medicine" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "氯吡格雷（以硫酸氢盐计）", "en": "clopidogrel (as hydrogen sulphate)" }, "value": 75, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "同一片中的氯吡格雷标示量；不是个人片数或频率", "en": "labelled clopidogrel amount in the same tablet; not an individual's tablet count or frequency" } }, { "ingredient": { "zh": "乙酰水杨酸（阿司匹林，ASA）", "en": "acetylsalicylic acid (aspirin, ASA)" }, "value": 100, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "同一片中的阿司匹林标示量；不是另一片药或个人用法", "en": "labelled aspirin amount in the same tablet; not a second tablet or an individual's regimen" } } ], "concentration": null, "container": { "typeCode": "unit_dose_blister_carton", "typeLabel": { "zh": "全铝单位剂量泡罩纸盒", "en": "all-aluminium unit-dose blister carton" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "片/包装", "en": "tablets per pack" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-06", "currentLabelDisplayed": true, "ndcDirectoryListed": false, "marketAvailability": "current_eu_authorisation_pack_record_not_live_inventory", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 30, "unit": { "zh": "片/包装", "en": "tablets per pack" } }, "physicalClues": { "color": { "zh": "浅粉色", "en": "light pink" }, "shape": { "zh": "椭圆形、轻微双凸薄膜衣片；外观线索不等于真伪鉴定", "en": "oval, slightly biconvex film-coated tablet; appearance is not authentication" }, "imprint": "C75 / A100", "scoreStatus": "no_source_backed_split_permission", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_e2d29127841a1da3", "label": "EMA：DuoPlavin 当前欧盟产品资料与电子说明书（75 mg/75 mg、75 mg/100 mg；2026-06-11 更新）", "url": "https://www.ema.europa.eu/en/documents/product-information/duoplavin-epar-product-information_en.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-06", "reviewedAt": "2026-09-06" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "eu-duoplavin-clopidogrel-75mg-aspirin-100mg-50x1-tablet-eu-1-10-619-011", "marketCode": "EU", "labelVersion": { "zh": "EMA 当前欧盟产品资料（2026-06-11 更新）", "en": "Current EMA EU product information (updated 11 Jun 2026)" }, "dosageForm": { "zh": "DuoPlavin 氯吡格雷 75 mg／阿司匹林 100 mg 薄膜衣片", "en": "DuoPlavin clopidogrel 75 mg/aspirin 100 mg film-coated tablet" }, "route": { "zh": "口服（固定两成分产品身份字段）", "en": "oral (fixed two-ingredient product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "EU/1/10/619/011", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片氯吡格雷 75 mg＋阿司匹林 100 mg；50 × 1 片单位剂量泡罩纸盒；不是一种 175 mg 药物", "en": "Clopidogrel 75 mg plus aspirin 100 mg per tablet; 50 × 1-tablet unit-dose blister carton; not one 175 mg medicine" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "氯吡格雷（以硫酸氢盐计）", "en": "clopidogrel (as hydrogen sulphate)" }, "value": 75, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "同一片中的氯吡格雷标示量；不是个人片数或频率", "en": "labelled clopidogrel amount in the same tablet; not an individual's tablet count or frequency" } }, { "ingredient": { "zh": "乙酰水杨酸（阿司匹林，ASA）", "en": "acetylsalicylic acid (aspirin, ASA)" }, "value": 100, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "同一片中的阿司匹林标示量；不是另一片药或个人用法", "en": "labelled aspirin amount in the same tablet; not a second tablet or an individual's regimen" } } ], "concentration": null, "container": { "typeCode": "unit_dose_blister_carton", "typeLabel": { "zh": "全铝单位剂量泡罩纸盒", "en": "all-aluminium unit-dose blister carton" }, "fill": null, "countPerPackage": 50, "countUnit": { "zh": "片/包装", "en": "tablets per pack" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-06", "currentLabelDisplayed": true, "ndcDirectoryListed": false, "marketAvailability": "current_eu_authorisation_pack_record_not_live_inventory", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 50, "unit": { "zh": "片/包装", "en": "tablets per pack" } }, "physicalClues": { "color": { "zh": "浅粉色", "en": "light pink" }, "shape": { "zh": "椭圆形、轻微双凸薄膜衣片；外观线索不等于真伪鉴定", "en": "oval, slightly biconvex film-coated tablet; appearance is not authentication" }, "imprint": "C75 / A100", "scoreStatus": "no_source_backed_split_permission", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_e2d29127841a1da3", "label": "EMA：DuoPlavin 当前欧盟产品资料与电子说明书（75 mg/75 mg、75 mg/100 mg；2026-06-11 更新）", "url": "https://www.ema.europa.eu/en/documents/product-information/duoplavin-epar-product-information_en.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-06", "reviewedAt": "2026-09-06" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "eu-duoplavin-clopidogrel-75mg-aspirin-100mg-84-tablet-eu-1-10-619-012", "marketCode": "EU", "labelVersion": { "zh": "EMA 当前欧盟产品资料（2026-06-11 更新）", "en": "Current EMA EU product information (updated 11 Jun 2026)" }, "dosageForm": { "zh": "DuoPlavin 氯吡格雷 75 mg／阿司匹林 100 mg 薄膜衣片", "en": "DuoPlavin clopidogrel 75 mg/aspirin 100 mg film-coated tablet" }, "route": { "zh": "口服（固定两成分产品身份字段）", "en": "oral (fixed two-ingredient product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "EU/1/10/619/012", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片氯吡格雷 75 mg＋阿司匹林 100 mg；84 片泡罩纸盒；不是一种 175 mg 药物", "en": "Clopidogrel 75 mg plus aspirin 100 mg per tablet; 84-tablet blister carton; not one 175 mg medicine" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "氯吡格雷（以硫酸氢盐计）", "en": "clopidogrel (as hydrogen sulphate)" }, "value": 75, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "同一片中的氯吡格雷标示量；不是个人片数或频率", "en": "labelled clopidogrel amount in the same tablet; not an individual's tablet count or frequency" } }, { "ingredient": { "zh": "乙酰水杨酸（阿司匹林，ASA）", "en": "acetylsalicylic acid (aspirin, ASA)" }, "value": 100, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "同一片中的阿司匹林标示量；不是另一片药或个人用法", "en": "labelled aspirin amount in the same tablet; not a second tablet or an individual's regimen" } } ], "concentration": null, "container": { "typeCode": "blister_carton", "typeLabel": { "zh": "全铝泡罩纸盒", "en": "all-aluminium blister carton" }, "fill": null, "countPerPackage": 84, "countUnit": { "zh": "片/包装", "en": "tablets per pack" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-06", "currentLabelDisplayed": true, "ndcDirectoryListed": false, "marketAvailability": "current_eu_authorisation_pack_record_not_live_inventory", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 84, "unit": { "zh": "片/包装", "en": "tablets per pack" } }, "physicalClues": { "color": { "zh": "浅粉色", "en": "light pink" }, "shape": { "zh": "椭圆形、轻微双凸薄膜衣片；外观线索不等于真伪鉴定", "en": "oval, slightly biconvex film-coated tablet; appearance is not authentication" }, "imprint": "C75 / A100", "scoreStatus": "no_source_backed_split_permission", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_e2d29127841a1da3", "label": "EMA：DuoPlavin 当前欧盟产品资料与电子说明书（75 mg/75 mg、75 mg/100 mg；2026-06-11 更新）", "url": "https://www.ema.europa.eu/en/documents/product-information/duoplavin-epar-product-information_en.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-06", "reviewedAt": "2026-09-06" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "eu-duoplavin-clopidogrel-75mg-aspirin-100mg-90x1-tablet-eu-1-10-619-013", "marketCode": "EU", "labelVersion": { "zh": "EMA 当前欧盟产品资料（2026-06-11 更新）", "en": "Current EMA EU product information (updated 11 Jun 2026)" }, "dosageForm": { "zh": "DuoPlavin 氯吡格雷 75 mg／阿司匹林 100 mg 薄膜衣片", "en": "DuoPlavin clopidogrel 75 mg/aspirin 100 mg film-coated tablet" }, "route": { "zh": "口服（固定两成分产品身份字段）", "en": "oral (fixed two-ingredient product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "EU/1/10/619/013", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片氯吡格雷 75 mg＋阿司匹林 100 mg；90 × 1 片单位剂量泡罩纸盒；不是一种 175 mg 药物", "en": "Clopidogrel 75 mg plus aspirin 100 mg per tablet; 90 × 1-tablet unit-dose blister carton; not one 175 mg medicine" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "氯吡格雷（以硫酸氢盐计）", "en": "clopidogrel (as hydrogen sulphate)" }, "value": 75, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "同一片中的氯吡格雷标示量；不是个人片数或频率", "en": "labelled clopidogrel amount in the same tablet; not an individual's tablet count or frequency" } }, { "ingredient": { "zh": "乙酰水杨酸（阿司匹林，ASA）", "en": "acetylsalicylic acid (aspirin, ASA)" }, "value": 100, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "同一片中的阿司匹林标示量；不是另一片药或个人用法", "en": "labelled aspirin amount in the same tablet; not a second tablet or an individual's regimen" } } ], "concentration": null, "container": { "typeCode": "unit_dose_blister_carton", "typeLabel": { "zh": "全铝单位剂量泡罩纸盒", "en": "all-aluminium unit-dose blister carton" }, "fill": null, "countPerPackage": 90, "countUnit": { "zh": "片/包装", "en": "tablets per pack" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-06", "currentLabelDisplayed": true, "ndcDirectoryListed": false, "marketAvailability": "current_eu_authorisation_pack_record_not_live_inventory", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 90, "unit": { "zh": "片/包装", "en": "tablets per pack" } }, "physicalClues": { "color": { "zh": "浅粉色", "en": "light pink" }, "shape": { "zh": "椭圆形、轻微双凸薄膜衣片；外观线索不等于真伪鉴定", "en": "oval, slightly biconvex film-coated tablet; appearance is not authentication" }, "imprint": "C75 / A100", "scoreStatus": "no_source_backed_split_permission", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_e2d29127841a1da3", "label": "EMA：DuoPlavin 当前欧盟产品资料与电子说明书（75 mg/75 mg、75 mg/100 mg；2026-06-11 更新）", "url": "https://www.ema.europa.eu/en/documents/product-information/duoplavin-epar-product-information_en.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-06", "reviewedAt": "2026-09-06" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "eu-duoplavin-clopidogrel-75mg-aspirin-100mg-100x1-tablet-eu-1-10-619-014", "marketCode": "EU", "labelVersion": { "zh": "EMA 当前欧盟产品资料（2026-06-11 更新）", "en": "Current EMA EU product information (updated 11 Jun 2026)" }, "dosageForm": { "zh": "DuoPlavin 氯吡格雷 75 mg／阿司匹林 100 mg 薄膜衣片", "en": "DuoPlavin clopidogrel 75 mg/aspirin 100 mg film-coated tablet" }, "route": { "zh": "口服（固定两成分产品身份字段）", "en": "oral (fixed two-ingredient product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "EU/1/10/619/014", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片氯吡格雷 75 mg＋阿司匹林 100 mg；100 × 1 片单位剂量泡罩纸盒；不是一种 175 mg 药物", "en": "Clopidogrel 75 mg plus aspirin 100 mg per tablet; 100 × 1-tablet unit-dose blister carton; not one 175 mg medicine" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "氯吡格雷（以硫酸氢盐计）", "en": "clopidogrel (as hydrogen sulphate)" }, "value": 75, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "同一片中的氯吡格雷标示量；不是个人片数或频率", "en": "labelled clopidogrel amount in the same tablet; not an individual's tablet count or frequency" } }, { "ingredient": { "zh": "乙酰水杨酸（阿司匹林，ASA）", "en": "acetylsalicylic acid (aspirin, ASA)" }, "value": 100, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "同一片中的阿司匹林标示量；不是另一片药或个人用法", "en": "labelled aspirin amount in the same tablet; not a second tablet or an individual's regimen" } } ], "concentration": null, "container": { "typeCode": "unit_dose_blister_carton", "typeLabel": { "zh": "全铝单位剂量泡罩纸盒", "en": "all-aluminium unit-dose blister carton" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "片/包装", "en": "tablets per pack" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-06", "currentLabelDisplayed": true, "ndcDirectoryListed": false, "marketAvailability": "current_eu_authorisation_pack_record_not_live_inventory", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "片/包装", "en": "tablets per pack" } }, "physicalClues": { "color": { "zh": "浅粉色", "en": "light pink" }, "shape": { "zh": "椭圆形、轻微双凸薄膜衣片；外观线索不等于真伪鉴定", "en": "oval, slightly biconvex film-coated tablet; appearance is not authentication" }, "imprint": "C75 / A100", "scoreStatus": "no_source_backed_split_permission", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_e2d29127841a1da3", "label": "EMA：DuoPlavin 当前欧盟产品资料与电子说明书（75 mg/75 mg、75 mg/100 mg；2026-06-11 更新）", "url": "https://www.ema.europa.eu/en/documents/product-information/duoplavin-epar-product-information_en.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-06", "reviewedAt": "2026-09-06" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "status": "withheld_repackaged_or_non_exact_visual", "title": { "zh": "官方文字可核对片色与刻印；没有准确包装图就明确留白", "en": "Official text supports colour and imprint checks; no exact pack image means an explicit blank" }, "summary": { "zh": "75/75 mg 为黄色、刻 C75／A75；75/100 mg 为浅粉色、刻 C75／A100。颜色、形状、刻印、泡罩或网页截图只能作为线索，不能单独证明真伪；本页没有准确官方包装图，不用相似药盒代替。", "en": "The 75/75 mg tablet is yellow and marked C75/A75; the 75/100 mg tablet is light pink and marked C75/A100. Colour, shape, imprint, blister or a web screenshot is only a clue and cannot establish authenticity; no similar pack substitutes for an unavailable exact official pack image." }, "source": { "id": "src_e2d29127841a1da3", "label": "EMA：DuoPlavin 当前欧盟产品资料与电子说明书（75 mg/75 mg、75 mg/100 mg；2026-06-11 更新）", "url": "https://www.ema.europa.eu/en/documents/product-information/duoplavin-epar-product-information_en.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-06", "reviewedAt": "2026-09-06" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "DuoPlavin 说明书放大阅读：一片两种成分，先查重复与出血", "en": "DuoPlavin enlarged label: two ingredients in one tablet—check duplication and bleeding first" }, "summary": { "zh": "75/75 与 75/100 的第一个 75 mg 都是氯吡格雷，第二个数字才是同一片中的阿司匹林。网页解释有效成分、包装、警戒信号和就医边界，不生成个人片数、停换药、漏服或手术停药方案。", "en": "In 75/75 and 75/100, the first 75 mg is clopidogrel and the second figure is aspirin in that same tablet. The page explains ingredients, packs, warning signals and care boundaries; it does not generate individual tablet counts, stopping/switching, missed-use or perioperative plans." }, "checks": [ { "zh": "这片药已经含阿司匹林与氯吡格雷。请把处方药、非处方止痛/感冒药、保健品及实际药盒一起核对；另一份阿司匹林、PLAVIX/氯吡格雷、其他抗血小板药、口服抗凝药、肝素、溶栓药或 NSAID 可能增加出血风险，不能靠错开时间自行消除。", "en": "This tablet already contains aspirin and clopidogrel. Review prescriptions, OTC pain/cold products, supplements and actual packs together. Another aspirin, PLAVIX/clopidogrel, antiplatelet, oral anticoagulant, heparin, thrombolytic or NSAID may increase bleeding risk; self-separating times does not remove that risk." }, { "zh": "呕血或咖啡渣样呕吐、黑便或血便、持续或无法控制的出血、突然严重头痛伴意识/言语/肢体变化、昏厥、呼吸困难或严重过敏表现，应及时使用当地医疗服务；严重急性表现使用急救。", "en": "Vomiting blood or coffee-ground material, black or bloody stool, persistent or uncontrolled bleeding, sudden severe headache with awareness/speech/limb change, fainting, breathing difficulty or severe allergy requires prompt local medical care; severe acute features require emergency help." }, { "zh": "手术、拔牙或任何侵入性操作前，应主动告知医生和牙医正在使用 DuoPlavin。不要根据网页自行停药：停用和操作时间必须由负责团队结合血栓与出血风险决定。", "en": "Tell physicians and dentists about DuoPlavin before surgery, dental work or another invasive procedure. Do not stop it from a web page; the responsible team must decide timing from both thrombotic and bleeding risks." }, { "zh": "严重肾功能或肝功能问题、活动性出血或消化性溃疡、对阿司匹林/NSAID 过敏或相关哮喘、孕期、既往跌倒出血，以及 SSRI、奥美拉唑/埃索美拉唑、利福平等同处药单时，应优先请专业人员核对当前说明书。", "en": "Severe kidney or liver problems, active bleeding or peptic ulcer, aspirin/NSAID allergy or related asthma, pregnancy, prior falls/bleeding, or co-listing of an SSRI, omeprazole/esomeprazole, rifampicin or similar medicines requires priority professional review of the current label." }, { "zh": "每片含乳糖 7 mg（75/75）或 8 mg（75/100），并含氢化蓖麻油 3.3 mg；后者可能引起胃部不适或腹泻。辅料差异适合用于准确产品过敏/耐受核对，不是“原研一定更好”的证据。", "en": "Each tablet contains lactose 7 mg (75/75) or 8 mg (75/100) and hydrogenated castor oil 3.3 mg; the latter may cause stomach upset or diarrhoea. Excipient differences support exact-product allergy/tolerance review and do not prove that an originator is always better." }, { "zh": "官方产品资料没有给本页可用于公众自行掰片的许可。即使片剂呈椭圆形，也不要把外观当成刻痕或等分依据；吞咽困难应让药师核对准确产品与可行方案。", "en": "The official product information provides no public self-splitting permission used by this page. An oval shape is not a score or equal-division instruction; swallowing difficulty needs pharmacist review of the exact product and an appropriate option." } ], "source": { "id": "src_e2d29127841a1da3", "label": "EMA：DuoPlavin 当前欧盟产品资料与电子说明书（75 mg/75 mg、75 mg/100 mg；2026-06-11 更新）", "url": "https://www.ema.europa.eu/en/documents/product-information/duoplavin-epar-product-information_en.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-06", "reviewedAt": "2026-09-06" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "为什么一片里有两条抗血小板路径：作用相加，也会让出血核对更重要", "en": "Why one tablet uses two antiplatelet pathways: additive action also raises the priority of bleeding review" }, "summary": { "zh": "氯吡格雷的活性代谢物不可逆抑制血小板 ADP 的 P2Y12 通路；阿司匹林不可逆抑制血小板环氧化酶并降低血栓烷 A2。两条路径解释固定复方设计，也解释为什么不能把另一种“防血栓药”随意叠加。", "en": "Clopidogrel's active metabolite irreversibly inhibits the platelet ADP P2Y12 pathway; aspirin irreversibly inhibits platelet cyclooxygenase and lowers thromboxane A2. The two pathways explain the fixed combination and why another antithrombotic medicine must not be added casually." }, "checks": [ { "zh": "CYP2C19 参与氯吡格雷活化，说明书说明低代谢者活性代谢物和血小板作用较低，也列出可识别基因型的检测；这不等于每个人都必须先做全基因筛查，更不允许网页据基因自行调片数。", "en": "CYP2C19 contributes to clopidogrel activation. The label notes lower active-metabolite exposure and platelet effect in poor metabolisers and the availability of genotype tests. This does not mean everyone needs whole-genome screening or permit a website to adjust tablet counts from genes." }, { "zh": "奥美拉唑、埃索美拉唑等 CYP2C19 抑制剂可能降低氯吡格雷活性代谢物；强诱导剂又可能增加活性代谢物与出血风险。相互作用必须按准确药名、剂量、适应证和完整药单由专业人员评估，不能生成通用错开时间表。", "en": "CYP2C19 inhibitors such as omeprazole and esomeprazole may reduce clopidogrel active metabolite, while strong inducers may increase active metabolite and bleeding risk. Review must use the exact medicine, amount, indication and complete list; the site does not generate a universal separation schedule." }, { "zh": "DuoPlavin、单方 PLAVIX、单方阿司匹林、AGGRENOX、BRILINTA、EFFIENT、PLETAL 与各种抗凝药不是按共同“防血栓”用途或总 mg 互换的同一种药。", "en": "DuoPlavin, single-ingredient PLAVIX, aspirin alone, AGGRENOX, BRILINTA, EFFIENT, PLETAL and anticoagulants are not one medicine that can be interchanged by a shared antithrombotic purpose or total milligrams." } ], "source": { "id": "src_e2d29127841a1da3", "label": "EMA：DuoPlavin 当前欧盟产品资料与电子说明书（75 mg/75 mg、75 mg/100 mg；2026-06-11 更新）", "url": "https://www.ema.europa.eu/en/documents/product-information/duoplavin-epar-product-information_en.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-06", "reviewedAt": "2026-09-06" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "DuoPlavin", "generic": "氯吡格雷／乙酰水杨酸（阿司匹林）", "dosageFormClass": "DuoPlavin 薄膜衣片把氯吡格雷 75 mg 与阿司匹林 75 mg 或 100 mg 放在同一片内。两个数字分属两种有效成分，不是 150 mg 或 175 mg 的单一药；本页不从椭圆外形推导可掰片。" }, "labelSource": { "id": "src_e2d29127841a1da3", "label": "EMA：DuoPlavin 当前欧盟产品资料与电子说明书（75 mg/75 mg、75 mg/100 mg；2026-06-11 更新）", "url": "https://www.ema.europa.eu/en/documents/product-information/duoplavin-epar-product-information_en.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-06", "reviewedAt": "2026-09-06" }, "productRoutes": [ { "source": { "id": "src_e2d29127841a1da3", "label": "EMA：DuoPlavin 当前欧盟产品资料与电子说明书（75 mg/75 mg、75 mg/100 mg；2026-06-11 更新）", "url": "https://www.ema.europa.eu/en/documents/product-information/duoplavin-epar-product-information_en.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-06", "reviewedAt": "2026-09-06" }, "status": "product_level_public_record_verified", "authority": { "zh": "EMA", "en": "EMA" }, "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "recordType": { "zh": "监管产品记录或欧盟产品资料", "en": "Regulatory product record or EU product information" }, "reviewedAt": "2026-09-06", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_c244551409ab29d8", "label": "EMA：DuoPlavin 欧盟当前 EPAR（EMEA/H/C/001143；产品资料 2026-06-11 更新）", "url": "https://www.ema.europa.eu/en/medicines/human/EPAR/duoplavin", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-06", "reviewedAt": "2026-09-06" }, "status": "product_level_public_record_verified", "authority": { "zh": "EMA", "en": "EMA" }, "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "recordType": { "zh": "监管产品记录或欧盟产品资料", "en": "Regulatory product record or EU product information" }, "reviewedAt": "2026-09-06", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "EMA", "en": "EMA" }, "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "recordType": { "zh": "监管产品记录或欧盟产品资料", "en": "Regulatory product record or EU product information" }, "reviewedAt": "2026-09-06", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "DuoPlavin 一片已经同时含氯吡格雷和阿司匹林。老人整理药盒时应先按成分核对是否又出现 PLAVIX/氯吡格雷、阿司匹林或含阿司匹林的止痛/感冒药，以及抗凝药、其他抗血小板药、肝素、溶栓药或 NSAID；疑似重复可能有临床意图，也可能是误服风险，不要自行叠加、错开、停用或替换。", "history": "EMA 记录 DuoPlavin 于 2010-03-14 获欧盟集中授权，当前产品资料于 2026-06-11 更新。两种规格都是固定复方，用于已分别使用氯吡格雷与阿司匹林的成人继续治疗；这一监管定位不能转换成个人是否该换为复方、每天几片或用多久的网页建议。", "sourceDocuments": [ { "id": "src_c244551409ab29d8", "label": "EMA：DuoPlavin 欧盟当前 EPAR（EMEA/H/C/001143；产品资料 2026-06-11 更新）", "url": "https://www.ema.europa.eu/en/medicines/human/EPAR/duoplavin", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-06", "reviewedAt": "2026-09-06" }, { "id": "src_e2d29127841a1da3", "label": "EMA：DuoPlavin 当前欧盟产品资料与电子说明书（75 mg/75 mg、75 mg/100 mg；2026-06-11 更新）", "url": "https://www.ema.europa.eu/en/documents/product-information/duoplavin-epar-product-information_en.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-06", "reviewedAt": "2026-09-06" }, { "id": "src_b9f3a330c9c24b24", "label": "EMA：DuoPlavin 面向公众的药品概览", "url": "https://www.ema.europa.eu/en/documents/overview/duoplavin-epar-medicine-overview_en.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "medicine_overview", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-06", "reviewedAt": "2026-09-06" } ], "applicationNumber": "EMA EMEA/H/C/001143（DuoPlavin clopidogrel/acetylsalicylic acid）", "approvalTimeline": [ { "date": "2010-03-14", "title": { "zh": "欧盟集中授权", "en": "EU central authorisation" }, "detail": { "zh": "EMA 当前 EPAR 将 DuoPlavin EMEA/H/C/001143 的授权日列为 2010-03-14。", "en": "The current EMA EPAR lists 14 Mar 2010 as the authorisation date for DuoPlavin EMEA/H/C/001143." }, "source": { "id": "src_c244551409ab29d8", "label": "EMA：DuoPlavin 欧盟当前 EPAR（EMEA/H/C/001143；产品资料 2026-06-11 更新）", "url": "https://www.ema.europa.eu/en/medicines/human/EPAR/duoplavin", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-06", "reviewedAt": "2026-09-06" } }, { "date": "2026-06-11", "title": { "zh": "EMA 产品资料更新", "en": "EMA product information updated" }, "detail": { "zh": "当前产品资料把两种强度、警告、相互作用、辅料、外观和包装号集中在同一官方文件中。", "en": "The current product information consolidates both strengths, warnings, interactions, excipients, appearance and pack authorisation numbers in one official document." }, "source": { "id": "src_e2d29127841a1da3", "label": "EMA：DuoPlavin 当前欧盟产品资料与电子说明书（75 mg/75 mg、75 mg/100 mg；2026-06-11 更新）", "url": "https://www.ema.europa.eu/en/documents/product-information/duoplavin-epar-product-information_en.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-06", "reviewedAt": "2026-09-06" } }, { "date": "2026-09-06", "title": { "zh": "公开资料复核", "en": "Public-source review" }, "detail": { "zh": "逐项核对 EPAR、产品资料与公众概览；未把另一撤回申请 EMEA/H/C/000874 当成当前产品。", "en": "EPAR, product information and public overview were checked item by item; the separate withdrawn application EMEA/H/C/000874 was not treated as the current product." }, "source": { "id": "src_c244551409ab29d8", "label": "EMA：DuoPlavin 欧盟当前 EPAR（EMEA/H/C/001143；产品资料 2026-06-11 更新）", "url": "https://www.ema.europa.eu/en/medicines/human/EPAR/duoplavin", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-06", "reviewedAt": "2026-09-06" } } ], "marketStatus": [ { "market": { "zh": "欧盟", "en": "European Union" }, "status": { "zh": "当前集中授权记录", "en": "Current centrally authorised record" }, "detail": { "zh": "15 个包装授权号来自当前产品资料；并非所有包装一定上市，网页不把授权号写成库存。", "en": "Fifteen pack authorisation numbers come from current product information; not all pack sizes may be marketed, so authorisation numbers are not live inventory." } }, { "market": { "zh": "中国大陆、美国、日本及其他市场", "en": "Mainland China, United States, Japan and other markets" }, "status": { "zh": "待逐项建立当地现行记录", "en": "Current local record not established" }, "detail": { "zh": "不从欧盟名称、包装或共同成分推定当地批准、品牌、参比身份、供应、医保、价格或可替代性。", "en": "EU names, packs or shared ingredients do not establish local approval, brand, reference status, supply, reimbursement, price or interchangeability." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "75/100 mg 是不是一片 175 mg 的药？", "en": "Is 75/100 mg one 175 mg medicine?" }, "answer": { "zh": "不是。75 mg 是同一片中的氯吡格雷，100 mg 是阿司匹林；两个有效成分必须分开理解，不能相加后与任何 175 mg 产品比较。", "en": "No. Seventy-five mg is clopidogrel and 100 mg is aspirin in that same tablet. The two active ingredients must remain separate and must not be summed for comparison with any 175 mg product." } }, { "question": { "zh": "已经吃 DuoPlavin，还能再吃阿司匹林或 PLAVIX 吗？", "en": "Can aspirin or PLAVIX be added when taking DuoPlavin?" }, "answer": { "zh": "不要自行添加。DuoPlavin 已含两种成分；把所有处方药、非处方药和药盒交给药师或临床医生核对。发现疑似重复也不要自行停药。", "en": "Do not add one yourself. DuoPlavin already contains both ingredients. Have a pharmacist or clinician review every prescription, OTC product and pack, and do not self-stop when possible duplication is found." } }, { "question": { "zh": "为了手术或拔牙，我可以先停几天吗？", "en": "Can I stop it for a few days before surgery or dental work?" }, "answer": { "zh": "网页不能给停药天数。提前告诉负责医生和牙医，由他们结合操作类型、出血风险和血栓风险制定方案。", "en": "A website cannot set the number of stopping days. Tell the responsible clinician and dentist in advance so they can balance the procedure, bleeding risk and thrombotic risk." } }, { "question": { "zh": "我需要做 CYP2C19 或全基因筛查吗？", "en": "Do I need CYP2C19 or whole-genome testing?" }, "answer": { "zh": "说明书确认 CYP2C19 与氯吡格雷活化有关并有基因检测，但没有支持网页要求所有人做全基因筛查。是否检测应由负责团队结合适应证、既往事件、相互作用和当地指南决定。", "en": "The label confirms a CYP2C19 role in clopidogrel activation and available genotype tests, but it does not support a website requiring whole-genome screening for everyone. The treating team should decide from the indication, prior events, interactions and local guidance." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "dosage-forms-are-part-of-medicine-identity", "how-to-read-a-drug-label", "how-to-review-a-family-medicine-list", "medicine-safety-and-pharmacovigilance" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/duoplavin-clopidogrel-aspirin/", "en": "https://origindrug.com/en/drugs/duoplavin-clopidogrel-aspirin/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "aggrenox-aspirin-dipyridamole", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-09-06", "status": "published_traceable_archive" }, "names": { "brand": "AGGRENOX", "generic": "阿司匹林／缓释双嘧达莫", "aliases": [ "Aggrenox", "aspirin and extended-release dipyridamole", "aspirin/dipyridamole", "aspirin dipyridamole", "阿司匹林双嘧达莫", "阿司匹林/缓释双嘧达莫", "阿司匹林双嘧达莫缓释胶囊", "双嘧达莫阿司匹林" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "抗凝与血液", "sourceArchiveMarket": "美国：AGGRENOX NDA 020884 的历史原品牌身份、RLD 与 DISCN 状态；一个准确历史分装商标签图；当前通用药标签用于安全阅读与包装比较。原品牌当前无准确公开包装主图，不用通用药或分装商图片冒充原厂当前包装。中国大陆、欧盟、日本及其他市场待逐项建立现行记录。", "dosageFormClass": "每粒复方胶囊同时装有阿司匹林 25 mg 普通释放小片和双嘧达莫 200 mg 缓释微丸。25 与 200 分属两种成分，不是 225 mg 的单一药物；整粒吞服，不得咀嚼或压碎。", "dosageFormClassCode": "oral_modified_release", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "1999（美国初始批准）", "archiveSponsorText": "Boehringer Ingelheim Pharmaceuticals, Inc.（美国历史 NDA 持有人）" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [ "AGGRENOX", "AGGRENOX 25 mg/200 mg", "aspirin and extended-release dipyridamole capsules", "阿司匹林双嘧达莫缓释胶囊" ], "excludedProductCues": [ "aspirin alone", "单方阿司匹林", "dipyridamole immediate-release tablets", "普通双嘧达莫片", "PERSANTINE", "clopidogrel", "PLAVIX", "warfarin", "COUMADIN" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-historical-aggrenox-aspirin-25mg-dipyridamole-er-200mg-60-capsule-ndc-0597000160", "marketCode": "US", "labelVersion": { "zh": "DailyMed 美国历史原品牌标签（2016-08-06 生效）", "en": "Historical U.S. DailyMed originator-brand label (effective 6 Aug 2016)" }, "dosageForm": { "zh": "AGGRENOX 阿司匹林／缓释双嘧达莫复方胶囊", "en": "AGGRENOX aspirin/extended-release dipyridamole combination capsule" }, "route": { "zh": "口服；历史原品牌产品身份字段", "en": "oral; historical originator-brand product-identity field" }, "routeCodes": [ "oral" ], "productCode": "NDC 0597-0001-60 / NDA 020884", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_capsule", "primaryDisplay": { "zh": "每粒含阿司匹林 25 mg（普通释放）＋双嘧达莫 200 mg（缓释）；60 粒瓶装；不是 225 mg 的单一成分", "en": "Each capsule contains aspirin 25 mg (immediate release) plus dipyridamole 200 mg (extended release); 60-count bottle; not one 225 mg ingredient" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "阿司匹林（普通释放糖衣片）", "en": "aspirin (immediate-release sugar-coated tablet)" }, "value": 25, "unit": "mg", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒复方胶囊中的阿司匹林标示量；不是个人粒数或频率", "en": "labelled aspirin amount in each combination capsule; not an individual's capsule count or frequency" } }, { "ingredient": { "zh": "双嘧达莫（缓释微丸）", "en": "dipyridamole (extended-release pellets)" }, "value": 200, "unit": "mg", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒复方胶囊中的缓释双嘧达莫标示量；不是另一粒药或个人用法", "en": "labelled extended-release dipyridamole amount in each combination capsule; not a second medicine unit or an individual's regimen" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "单位使用瓶装", "en": "unit-of-use bottle" }, "fill": null, "countPerPackage": 60, "countUnit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-06", "currentLabelDisplayed": false, "ndcDirectoryListed": false, "marketAvailability": "historical_discontinued_rld", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 60, "unit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "physicalClues": { "color": { "zh": "红色帽、象牙色体；内含黄色缓释微丸和一枚白色普通释放阿司匹林圆片", "en": "red cap and ivory body; contains yellow extended-release pellets and one round white immediate-release aspirin tablet" }, "shape": { "zh": "硬明胶胶囊；必须整粒吞服，不得咀嚼或压碎", "en": "hard-gelatin capsule; swallow whole and do not chew or crush" }, "imprint": "Boehringer Ingelheim logo;01A", "scoreStatus": "capsule_not_a_split_tablet", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_bb227df91a373b15", "label": "DailyMed（NLM）：AGGRENOX 阿司匹林 25 mg／缓释双嘧达莫 200 mg 美国历史原品牌标签（2016-08-06 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=f07c8535-f9fb-4697-9b63-1ab22210efc9", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_historical_record", "documentKind": "historical_product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-06", "reviewedAt": "2026-09-06" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-historical-repackaged-aggrenox-25mg-200mg-60-capsule-ndc-5486851430", "marketCode": "US", "labelVersion": { "zh": "DailyMed 2012 历史分装商标签；源产品 NDC 0597-0001", "en": "Historical 2012 DailyMed repackager label; source product NDC 0597-0001" }, "dosageForm": { "zh": "AGGRENOX 阿司匹林／缓释双嘧达莫复方胶囊", "en": "AGGRENOX aspirin/extended-release dipyridamole combination capsule" }, "route": { "zh": "口服；历史分装商包装身份字段", "en": "oral; historical repackager pack-identity field" }, "routeCodes": [ "oral" ], "productCode": "NDC 54868-5143-0 (source NDC 0597-0001)", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_capsule", "primaryDisplay": { "zh": "每粒阿司匹林 25 mg＋缓释双嘧达莫 200 mg；60 粒历史分装包装；图片是分装商标签，不是原厂纸盒或当前库存", "en": "Aspirin 25 mg plus extended-release dipyridamole 200 mg per capsule; historical 60-count repackaged pack; image is a repackager label, not the originator carton or current stock" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=5143.jpg&setid=e729d829-4bd0-4074-85ea-e0f9f5d7cdb5&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "阿司匹林（普通释放糖衣片）", "en": "aspirin (immediate-release sugar-coated tablet)" }, "value": 25, "unit": "mg", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒复方胶囊中的阿司匹林标示量；不是个人粒数或频率", "en": "labelled aspirin amount in each combination capsule; not an individual's capsule count or frequency" } }, { "ingredient": { "zh": "双嘧达莫（缓释微丸）", "en": "dipyridamole (extended-release pellets)" }, "value": 200, "unit": "mg", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒复方胶囊中的缓释双嘧达莫标示量；不是另一粒药或个人用法", "en": "labelled extended-release dipyridamole amount in each combination capsule; not a second medicine unit or an individual's regimen" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "单位使用瓶装", "en": "unit-of-use bottle" }, "fill": null, "countPerPackage": 60, "countUnit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-06", "currentLabelDisplayed": false, "ndcDirectoryListed": false, "marketAvailability": "historical_repackaged_brand_source_product", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 60, "unit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "physicalClues": { "color": { "zh": "红色帽、象牙色体；内含黄色缓释微丸和一枚白色普通释放阿司匹林圆片", "en": "red cap and ivory body; contains yellow extended-release pellets and one round white immediate-release aspirin tablet" }, "shape": { "zh": "硬明胶胶囊；必须整粒吞服，不得咀嚼或压碎", "en": "hard-gelatin capsule; swallow whole and do not chew or crush" }, "imprint": "Boehringer Ingelheim logo;01A", "scoreStatus": "capsule_not_a_split_tablet", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_687733cfe5f4baeb", "label": "DailyMed（NLM）：AGGRENOX 25 mg／200 mg、60 粒历史分装商包装标签（Physicians Total Care；源 NDC 0597-0001）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=e729d829-4bd0-4074-85ea-e0f9f5d7cdb5", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_historical_record", "documentKind": "historical_repackaged_product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-06", "reviewedAt": "2026-09-06" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-current-generic-aspirin-25mg-dipyridamole-er-200mg-30-capsule-ndc-6846240530", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国通用药标签（2025-09 修订）", "en": "Current U.S. DailyMed generic label (revised Sep 2025)" }, "dosageForm": { "zh": "阿司匹林 25 mg／缓释双嘧达莫 200 mg 复方胶囊", "en": "aspirin 25 mg/extended-release dipyridamole 200 mg combination capsule" }, "route": { "zh": "口服；当前通用药比较项", "en": "oral; current generic comparator" }, "routeCodes": [ "oral" ], "productCode": "NDC 68462-405-30", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_capsule", "primaryDisplay": { "zh": "每粒阿司匹林 25 mg＋缓释双嘧达莫 200 mg；30 粒瓶装；这是当前通用药比较项，不是 AGGRENOX 原品牌包装", "en": "Aspirin 25 mg plus extended-release dipyridamole 200 mg per capsule; 30-count bottle; this is a current generic comparator, not an AGGRENOX originator-brand pack" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "阿司匹林（普通释放糖衣片）", "en": "aspirin (immediate-release sugar-coated tablet)" }, "value": 25, "unit": "mg", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒复方胶囊中的阿司匹林标示量；不是个人粒数或频率", "en": "labelled aspirin amount in each combination capsule; not an individual's capsule count or frequency" } }, { "ingredient": { "zh": "双嘧达莫（缓释微丸）", "en": "dipyridamole (extended-release pellets)" }, "value": 200, "unit": "mg", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒复方胶囊中的缓释双嘧达莫标示量；不是另一粒药或个人用法", "en": "labelled extended-release dipyridamole amount in each combination capsule; not a second medicine unit or an individual's regimen" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-06", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "current_generic_label_record", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 30, "unit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "physicalClues": { "color": { "zh": "红棕色不透明帽、乳白色不透明体", "en": "reddish-brown opaque cap and cream opaque body" }, "shape": { "zh": "0el 号硬明胶胶囊；内含淡黄至黄色缓释微丸和白至类白色普通释放小片", "en": "size 0el hard-gelatin capsule; contains light-yellow to yellow extended-release pellets and a white to off-white immediate-release tablet" }, "imprint": "G;405", "scoreStatus": "capsule_not_a_split_tablet", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_50f4b5ef025b301b", "label": "DailyMed（NLM）：阿司匹林 25 mg／缓释双嘧达莫 200 mg 胶囊当前美国通用药标签（2025-09 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=467d6ce3-bc05-4aa1-87cc-3214fd628d39", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-06", "reviewedAt": "2026-09-06" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-current-generic-aspirin-25mg-dipyridamole-er-200mg-60-capsule-ndc-6846240560", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国通用药标签（2025-09 修订）", "en": "Current U.S. DailyMed generic label (revised Sep 2025)" }, "dosageForm": { "zh": "阿司匹林 25 mg／缓释双嘧达莫 200 mg 复方胶囊", "en": "aspirin 25 mg/extended-release dipyridamole 200 mg combination capsule" }, "route": { "zh": "口服；当前通用药比较项", "en": "oral; current generic comparator" }, "routeCodes": [ "oral" ], "productCode": "NDC 68462-405-60", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_capsule", "primaryDisplay": { "zh": "每粒阿司匹林 25 mg＋缓释双嘧达莫 200 mg；60 粒瓶装；这是当前通用药比较项，不是 AGGRENOX 原品牌包装", "en": "Aspirin 25 mg plus extended-release dipyridamole 200 mg per capsule; 60-count bottle; this is a current generic comparator, not an AGGRENOX originator-brand pack" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=LBL25mg-200mg60s.jpg&setid=467d6ce3-bc05-4aa1-87cc-3214fd628d39&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "阿司匹林（普通释放糖衣片）", "en": "aspirin (immediate-release sugar-coated tablet)" }, "value": 25, "unit": "mg", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒复方胶囊中的阿司匹林标示量；不是个人粒数或频率", "en": "labelled aspirin amount in each combination capsule; not an individual's capsule count or frequency" } }, { "ingredient": { "zh": "双嘧达莫（缓释微丸）", "en": "dipyridamole (extended-release pellets)" }, "value": 200, "unit": "mg", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒复方胶囊中的缓释双嘧达莫标示量；不是另一粒药或个人用法", "en": "labelled extended-release dipyridamole amount in each combination capsule; not a second medicine unit or an individual's regimen" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 60, "countUnit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-06", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "current_generic_label_record", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 60, "unit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "physicalClues": { "color": { "zh": "红棕色不透明帽、乳白色不透明体", "en": "reddish-brown opaque cap and cream opaque body" }, "shape": { "zh": "0el 号硬明胶胶囊；内含淡黄至黄色缓释微丸和白至类白色普通释放小片", "en": "size 0el hard-gelatin capsule; contains light-yellow to yellow extended-release pellets and a white to off-white immediate-release tablet" }, "imprint": "G;405", "scoreStatus": "capsule_not_a_split_tablet", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_50f4b5ef025b301b", "label": "DailyMed（NLM）：阿司匹林 25 mg／缓释双嘧达莫 200 mg 胶囊当前美国通用药标签（2025-09 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=467d6ce3-bc05-4aa1-87cc-3214fd628d39", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-06", "reviewedAt": "2026-09-06" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "status": "withheld_repackaged_or_non_exact_visual", "title": { "zh": "没有原厂当前包装图时，明确留白，不用相似胶囊代替", "en": "When no current originator-pack image is available, leave it explicit rather than substitute a similar capsule" }, "summary": { "zh": "历史原品牌标签描述红帽、象牙色体、BI 标志与 01A；当前通用药则是 G／405。两者只能按各自准确身份阅读。历史分装商图只保留在对应分装记录里，不进入原品牌主图位；颜色、形状、微丸或一张分装标签都不能单独证明真伪，也不用于鉴定真伪。", "en": "The historical originator label describes a red cap, ivory body, BI logo and 01A; the current generic is G/405. Each belongs only to its exact identity. The historical repackager image remains only in its matching repackager record and is not used as the originator hero visual; colour, shape, pellets or one label cannot establish authenticity." }, "source": { "id": "src_bb227df91a373b15", "label": "DailyMed（NLM）：AGGRENOX 阿司匹林 25 mg／缓释双嘧达莫 200 mg 美国历史原品牌标签（2016-08-06 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=f07c8535-f9fb-4697-9b63-1ab22210efc9", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_historical_record", "documentKind": "historical_product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-06", "reviewedAt": "2026-09-06" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "AGGRENOX 说明书放大阅读：一粒两种成分，先查重复，再看出血警报", "en": "AGGRENOX enlarged label: two ingredients in one capsule—check duplication before bleeding alarms" }, "summary": { "zh": "25 mg 是每粒中的阿司匹林，200 mg 是同一粒中的缓释双嘧达莫；不是两粒，也不是可拆开的配方。网页帮助识别成分、包装数字、完整吞服与警戒信号，不生成个人粒数、停换药或漏服方案。", "en": "25 mg is the aspirin in each capsule and 200 mg is extended-release dipyridamole in that same capsule. They are not two capsules or a formulation to dismantle. The page supports ingredient, pack-number, whole-capsule and warning-signal literacy, not individual capsule counts, stopping/switching or missed-use plans." }, "checks": [ { "zh": "胶囊必须整粒吞服，不得咀嚼或压碎。它不能用单方阿司匹林片和普通双嘧达莫片按毫克自行拼成，也不能把胶囊打开后分微丸、丢掉白色小片或只吃其中一部分。吞咽困难应请药师核对准确替代产品。", "en": "Swallow the capsule whole; do not chew or crush it. Do not self-assemble it from aspirin tablets and immediate-release dipyridamole, open it to divide pellets, discard the white tablet or take only part. Dysphagia requires pharmacist review of an exact alternative product." }, { "zh": "这粒复方已经含阿司匹林。处方药、非处方止痛药、感冒药和保健品都应按有效成分核对；另见阿司匹林、抗凝药、其他抗血小板药、肝素、溶栓药、阿那格雷或长期 NSAID 时，不要自行叠加或靠错开时间消除风险。", "en": "This combination already contains aspirin. Check active ingredients across prescriptions, OTC pain/cold products and supplements. If another aspirin, anticoagulant, antiplatelet, heparin, fibrinolytic, anagrelide or chronically used NSAID appears, do not self-combine it or assume timing separation removes risk." }, { "zh": "呕血或咖啡渣样呕吐、黑便或血便、持续或无法控制的出血、严重头痛伴嗜睡/意识或记忆改变、昏厥，以及新的或加重的胸痛，应及时使用当地医疗服务；严重急性表现使用急救。", "en": "Vomiting blood or coffee-ground material, black or bloody stool, persistent or uncontrolled bleeding, severe headache with drowsiness, awareness or memory change, loss of consciousness, or new/worsening chest pain requires prompt local medical care; severe acute features require emergency help." }, { "zh": "开始后头痛并不少见，但网页不能把说明书里的专业替代方案变成自行改服法。严重或难以耐受的头痛、计划药物负荷试验、手术/拔牙、活动性消化性溃疡、肾肝问题、低血压、重症肌无力、怀孕或大量饮酒均应主动告知负责团队。", "en": "Headache is not uncommon after initiation, but the site must not turn the label's clinician-directed alternative into self-adjustment. Severe or intolerable headache, planned pharmacologic stress testing, surgery/dental work, active peptic ulcer, kidney/liver problems, low blood pressure, myasthenia gravis, pregnancy or heavy alcohol use should be disclosed to the responsible team." } ], "source": { "id": "src_50f4b5ef025b301b", "label": "DailyMed（NLM）：阿司匹林 25 mg／缓释双嘧达莫 200 mg 胶囊当前美国通用药标签（2025-09 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=467d6ce3-bc05-4aa1-87cc-3214fd628d39", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-06", "reviewedAt": "2026-09-06" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "为什么是两种抗血小板路径：作用相加，不代表可以随意加更多“血液药”", "en": "Why two antiplatelet pathways: additive action does not permit adding more ‘blood thinners’" }, "summary": { "zh": "标签把抗血栓作用解释为双嘧达莫与阿司匹林抗血小板效应的相加。阿司匹林不可逆抑制血小板环氧化酶、降低血栓烷 A2；双嘧达莫增加腺苷相关信号并抑制 cGMP 磷酸二酯酶。机制解释产品设计，但不能替个人判断是否适合。", "en": "The label attributes antithrombotic action to additive antiplatelet effects of dipyridamole and aspirin. Aspirin irreversibly inhibits platelet cyclooxygenase and lowers thromboxane A2; dipyridamole augments adenosine-related signalling and inhibits cGMP phosphodiesterase. Mechanism explains the product design but cannot decide individual suitability." }, "checks": [ { "zh": "AGGRENOX、单方阿司匹林、PLAVIX/氯吡格雷、BRILINTA/替格瑞洛、EFFIENT/普拉格雷、PLETAL/西洛他唑和口服抗凝药机制、剂型和证据边界不同，不能按“防血栓”用途或 mg 自行换算、轮换或叠加。", "en": "AGGRENOX, aspirin alone, PLAVIX/clopidogrel, BRILINTA/ticagrelor, EFFIENT/prasugrel, PLETAL/cilostazol and oral anticoagulants differ in mechanism, product form and evidence boundaries. A shared antithrombotic purpose or milligram figure does not permit self-conversion, rotation or combination." }, { "zh": "双嘧达莫有血管扩张作用，可能出现头痛、头晕、低血压或胸痛变化。老人出现跌倒、晕厥、明显虚弱或胸痛变化时，要把实际药盒、血压记录与完整药单一起交给医疗团队核对。", "en": "Dipyridamole has vasodilatory effects, so headache, dizziness, low blood pressure or altered chest pain may occur. An older adult with a fall, fainting, marked weakness or changed chest pain should have the actual pack, blood-pressure record and complete medicine list reviewed together." }, { "zh": "低剂量阿司匹林在这粒复方里的存在，不表示它足以覆盖另一个心脏适应证，也不表示应自行再加阿司匹林。药物选择需由负责团队按具体适应证、出血与血栓风险核对。", "en": "The low-dose aspirin inside this combination does not mean it covers another cardiac indication, nor that extra aspirin should be added. The responsible team must review the exact indication and both bleeding and thrombotic risks." } ], "source": { "id": "src_bb227df91a373b15", "label": "DailyMed（NLM）：AGGRENOX 阿司匹林 25 mg／缓释双嘧达莫 200 mg 美国历史原品牌标签（2016-08-06 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=f07c8535-f9fb-4697-9b63-1ab22210efc9", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_historical_record", "documentKind": "historical_product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-06", "reviewedAt": "2026-09-06" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "AGGRENOX", "generic": "阿司匹林／缓释双嘧达莫", "dosageFormClass": "每粒复方胶囊同时装有阿司匹林 25 mg 普通释放小片和双嘧达莫 200 mg 缓释微丸。25 与 200 分属两种成分，不是 225 mg 的单一药物；整粒吞服，不得咀嚼或压碎。" }, "labelSource": { "id": "src_50f4b5ef025b301b", "label": "DailyMed（NLM）：阿司匹林 25 mg／缓释双嘧达莫 200 mg 胶囊当前美国通用药标签（2025-09 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=467d6ce3-bc05-4aa1-87cc-3214fd628d39", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-06", "reviewedAt": "2026-09-06" }, "productRoutes": [ { "source": { "id": "src_50f4b5ef025b301b", "label": "DailyMed（NLM）：阿司匹林 25 mg／缓释双嘧达莫 200 mg 胶囊当前美国通用药标签（2025-09 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=467d6ce3-bc05-4aa1-87cc-3214fd628d39", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-06", "reviewedAt": "2026-09-06" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-09-06", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_10e511bf83430e3b", "label": "FDA Orange Book：AGGRENOX NDA 020884 美国历史 RLD／DISCN 记录", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-08-29", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-09-06", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "AGGRENOX 是把低剂量阿司匹林和缓释双嘧达莫装在同一粒胶囊内的历史美国原品牌。老人整理药盒时最容易漏看的是“这粒药已经含阿司匹林”：若药单另有阿司匹林、氯吡格雷、替格瑞洛、华法林、阿哌沙班、利伐沙班、肝素或布洛芬/萘普生等 NSAID，应先让药师或临床医生核对出血风险，不要自行叠加、错开、停用或替换。", "history": "FDA 于 1999-11-22 批准 NDA 020884。原始医学审评记录了 Asasantine／AGGRENOX 国际开发和 ESPS2 证据。DailyMed 保留原品牌历史标签与多个历史分装商标签；当前 Orange Book 行为 DISCN，而当前通用药标签仍在更新，因此本页把历史原品牌、分装包装与当前通用药严格分开。", "sourceDocuments": [ { "id": "src_bb227df91a373b15", "label": "DailyMed（NLM）：AGGRENOX 阿司匹林 25 mg／缓释双嘧达莫 200 mg 美国历史原品牌标签（2016-08-06 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=f07c8535-f9fb-4697-9b63-1ab22210efc9", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_historical_record", "documentKind": "historical_product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-06", "reviewedAt": "2026-09-06" }, { "id": "src_687733cfe5f4baeb", "label": "DailyMed（NLM）：AGGRENOX 25 mg／200 mg、60 粒历史分装商包装标签（Physicians Total Care；源 NDC 0597-0001）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=e729d829-4bd0-4074-85ea-e0f9f5d7cdb5", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_historical_record", "documentKind": "historical_repackaged_product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-06", "reviewedAt": "2026-09-06" }, { "id": "src_50f4b5ef025b301b", "label": "DailyMed（NLM）：阿司匹林 25 mg／缓释双嘧达莫 200 mg 胶囊当前美国通用药标签（2025-09 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=467d6ce3-bc05-4aa1-87cc-3214fd628d39", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-06", "reviewedAt": "2026-09-06" }, { "id": "src_183570ab7b9ff3af", "label": "FDA：AGGRENOX NDA 020884 最初批准标签（1999）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20884_aggrenox_prntlbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_historical_record", "documentKind": "historical_product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-06", "reviewedAt": "2026-09-06" }, { "id": "src_31e6352e78acfb22", "label": "FDA：AGGRENOX NDA 020884 原始医学审评（ESPS2 与国际开发史）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20884_AGGRENOX_medr_P2.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_historical_record", "documentKind": "regulatory_review", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-06", "reviewedAt": "2026-09-06" }, { "id": "src_10e511bf83430e3b", "label": "FDA Orange Book：AGGRENOX NDA 020884 美国历史 RLD／DISCN 记录", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } ], "applicationNumber": "FDA NDA 020884（AGGRENOX aspirin 25 mg / extended-release dipyridamole 200 mg capsules）", "approvalTimeline": [ { "date": "1999-11-22", "title": { "zh": "FDA 初始批准 AGGRENOX", "en": "FDA initially approved AGGRENOX" }, "detail": { "zh": "Orange Book 将 NDA 020884 产品 001 的批准日列为 1999-11-22；最初标签列 Initial U.S. Approval: 1999。", "en": "The Orange Book lists 22 Nov 1999 for Product 001 under NDA 020884, and the original label states Initial U.S. Approval: 1999." }, "source": { "id": "src_10e511bf83430e3b", "label": "FDA Orange Book：AGGRENOX NDA 020884 美国历史 RLD／DISCN 记录", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } }, { "date": "1999", "title": { "zh": "原始医学审评记录固定复方与 ESPS2", "en": "Original medical review records the fixed combination and ESPS2" }, "detail": { "zh": "FDA 医学审评把双嘧达莫缓释与普通释放阿司匹林固定复方、国际 Asasantine 开发和 ESPS2 试验背景相连；历史证据不能直接代表今日个体获益。", "en": "FDA's medical review links the fixed extended-release dipyridamole/immediate-release aspirin combination to international Asasantine development and ESPS2. Historical evidence cannot itself establish an individual's present benefit." }, "source": { "id": "src_31e6352e78acfb22", "label": "FDA：AGGRENOX NDA 020884 原始医学审评（ESPS2 与国际开发史）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20884_AGGRENOX_medr_P2.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_historical_record", "documentKind": "regulatory_review", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-06", "reviewedAt": "2026-09-06" } }, { "date": "2026-09-06", "title": { "zh": "当前橙皮书核对为历史 RLD／DISCN", "en": "Current Orange Book review: historical RLD/DISCN" }, "detail": { "zh": "产品 001 为 RLD、非 RS、状态 DISCN，并带有并非因安全性或有效性撤市的联邦公报判定。", "en": "Product 001 is an RLD, not the RS, and is DISCN, with a Federal Register determination that it was not discontinued or withdrawn for safety or effectiveness reasons." }, "source": { "id": "src_10e511bf83430e3b", "label": "FDA Orange Book：AGGRENOX NDA 020884 美国历史 RLD／DISCN 记录", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "原品牌历史 RLD 已停止销售；当前通用药标签存在", "en": "Historical originator RLD discontinued; current generic labels exist" }, "detail": { "zh": "本页展示原品牌历史身份、一个历史分装商标签图和当前通用药比较项；它们不表示 AGGRENOX 原品牌当前有货。", "en": "The page shows historical originator identity, one historical repackager label and current generic comparators. None establishes current AGGRENOX originator stock." } }, { "market": { "zh": "中国大陆、欧盟、日本及其他市场", "en": "Mainland China, EU, Japan and other markets" }, "status": { "zh": "待逐项建立现行市场记录", "en": "Current market record not established" }, "detail": { "zh": "不从美国 NDA、Asasantine 名称或共同成分推定当地批准、商品名、供应、医保、原研/仿制关系或可替代性。", "en": "No local approval, brand, supply, reimbursement, originator/generic relationship or interchangeability is inferred from the U.S. NDA, Asasantine name or shared ingredients." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "这粒药已经含阿司匹林，我还能再吃阿司匹林或止痛药吗？", "en": "This capsule already contains aspirin. Can I add aspirin or a pain medicine?" }, "answer": { "zh": "不要自行添加。先把处方药、非处方止痛/感冒药和保健品的全部有效成分交给药师或临床医生核对；另一份阿司匹林、NSAID、抗血小板药或抗凝药可能改变出血风险。", "en": "Do not add one yourself. Have a pharmacist or clinician review every active ingredient across prescriptions, OTC pain/cold products and supplements; another aspirin, NSAID, antiplatelet or anticoagulant can change bleeding risk." } }, { "question": { "zh": "25 mg 加 200 mg，是不是一粒 225 mg 的药？", "en": "Does 25 mg plus 200 mg make one 225 mg medicine?" }, "answer": { "zh": "不是。25 mg 属于阿司匹林普通释放小片，200 mg 属于双嘧达莫缓释微丸；两种成分、两种释放设计必须分别理解，不能相加后与任何 225 mg 产品比较或换算。", "en": "No. The 25 mg belongs to the immediate-release aspirin tablet and the 200 mg to extended-release dipyridamole pellets. They are separate ingredients and release designs and must not be summed for comparison or conversion to any 225 mg product." } }, { "question": { "zh": "胶囊可以打开，把里面分一半吗？", "en": "Can the capsule be opened and half the contents used?" }, "answer": { "zh": "不可以。标签要求整粒吞服，不得咀嚼或压碎；胶囊内还有两种不同形态的成分，目测分一半不能保证成分比例或释放特征。吞咽困难应让药师核对准确替代产品。", "en": "No. The label requires swallowing whole and not chewing or crushing. The capsule also contains two ingredients in different physical forms, so visual halving cannot preserve ingredient ratio or release. Ask a pharmacist to review an exact alternative for swallowing difficulty." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "dosage-forms-are-part-of-medicine-identity", "how-to-read-a-drug-label", "how-to-review-a-family-medicine-list", "medicine-safety-and-pharmacovigilance" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/aggrenox-aspirin-dipyridamole/", "en": "https://origindrug.com/en/drugs/aggrenox-aspirin-dipyridamole/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "razadyne-galantamine", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-09-06", "status": "published_traceable_archive" }, "names": { "brand": "RAZADYNE / RAZADYNE ER", "generic": "氢溴酸加兰他敏", "aliases": [ "Razadyne", "Razadyne ER", "Reminyl", "galantamine", "galantamine hydrobromide", "加兰他敏", "氢溴酸加兰他敏", "加兰他敏缓释胶囊", "加兰他敏片" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "神经与认知", "sourceArchiveMarket": "美国：RAZADYNE 普通片 NDA 021169、口服液 NDA 021224 与 RAZADYNE ER 缓释胶囊 NDA 021615 的历史品牌身份；六张准确历史包装面板；当前通用名安全标签作为补充语境。FDA 2025 审评资料说明三个品牌剂型均已不再销售，不能把仍可访问的旧标签写成当前供应。", "dosageFormClass": "历史品牌普通片 4/8/12 mg、缓释胶囊 8/16/24 mg；另有历史口服液申请，但本页尚未展示准确口服液包装面板", "dosageFormClassCode": "oral_modified_release", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "2001（美国普通片最初营销记录；RAZADYNE ER 于 2004-12-24 开始营销）", "archiveSponsorText": "Janssen Pharmaceuticals, Inc.（历史美国品牌标签所列）" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [ "RAZADYNE", "RAZADYNE ER", "Reminyl", "加兰他敏", "氢溴酸加兰他敏" ], "excludedProductCues": [ "donepezil", "Aricept", "rivastigmine", "Exelon", "memantine", "Namenda", "Namzaric" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-razadyne-galantamine-er-capsule-8mg-30-count-ndc-5045838730", "marketCode": "US", "labelVersion": { "zh": "DailyMed 美国历史品牌标签（SPL v25；2022-10-11 生效）；FDA 2025 审评资料确认品牌申请已停止销售", "en": "Historical U.S. DailyMed brand label (SPL v25; effective 11 Oct 2022); FDA's 2025 review confirms the brand applications are discontinued" }, "dosageForm": { "zh": "RAZADYNE ER 氢溴酸加兰他敏缓释胶囊", "en": "RAZADYNE ER galantamine hydrobromide extended-release capsule" }, "route": { "zh": "口服；历史品牌产品身份字段", "en": "oral; historical brand product-identity field" }, "routeCodes": [ "oral" ], "productCode": "NDC 50458-387-30", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_capsule", "primaryDisplay": { "zh": "每粒相当于加兰他敏 8 mg（以氢溴酸加兰他敏 10.25 mg 提供）；30 粒瓶装；历史品牌条目已停止销售", "en": "Equivalent to galantamine 8 mg per capsule (supplied as galantamine hydrobromide 10.25 mg); 30-count bottle; historical brand listing discontinued" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=razadyne-14.jpg&archiveid=673830", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "加兰他敏（以氢溴酸加兰他敏提供）", "en": "galantamine (supplied as galantamine hydrobromide)" }, "value": 8, "unit": "mg", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒标签标示量；不是个人粒数、频率、换算或重新开始指令", "en": "labelled amount per capsule; not an individual's count, frequency, conversion or restart instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-06", "currentLabelDisplayed": false, "ndcDirectoryListed": false, "marketAvailability": "historical_discontinued_brand", "marketingStartDate": null, "marketingEndDate": "2023-05-31", "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 30, "unit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "physicalClues": { "color": { "zh": "白色不透明", "en": "white opaque" }, "shape": { "zh": "硬明胶胶囊，约 14 mm，无刻痕", "en": "hard-gelatin capsule, approximately 14 mm, unscored" }, "imprint": "GAL;8", "scoreStatus": "capsule_not_a_split_tablet", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_494a865c97459a50", "label": "DailyMed（NLM）：RAZADYNE／RAZADYNE ER 美国历史品牌标签（Janssen；SPL v25；生效日 2022-10-11）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ec9b5a9c-8caf-4f9b-8c1b-209b2de556dc", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-06", "reviewedAt": "2026-09-06" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-razadyne-galantamine-er-capsule-16mg-30-count-ndc-5045838830", "marketCode": "US", "labelVersion": { "zh": "DailyMed 美国历史品牌标签（SPL v25；2022-10-11 生效）；FDA 2025 审评资料确认品牌申请已停止销售", "en": "Historical U.S. DailyMed brand label (SPL v25; effective 11 Oct 2022); FDA's 2025 review confirms the brand applications are discontinued" }, "dosageForm": { "zh": "RAZADYNE ER 氢溴酸加兰他敏缓释胶囊", "en": "RAZADYNE ER galantamine hydrobromide extended-release capsule" }, "route": { "zh": "口服；历史品牌产品身份字段", "en": "oral; historical brand product-identity field" }, "routeCodes": [ "oral" ], "productCode": "NDC 50458-388-30", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_capsule", "primaryDisplay": { "zh": "每粒相当于加兰他敏 16 mg（以氢溴酸加兰他敏 20.51 mg 提供）；30 粒瓶装；历史品牌条目已停止销售", "en": "Equivalent to galantamine 16 mg per capsule (supplied as galantamine hydrobromide 20.51 mg); 30-count bottle; historical brand listing discontinued" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=razadyne-15.jpg&archiveid=673830", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "加兰他敏（以氢溴酸加兰他敏提供）", "en": "galantamine (supplied as galantamine hydrobromide)" }, "value": 16, "unit": "mg", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒标签标示量；不是个人粒数、频率、换算或重新开始指令", "en": "labelled amount per capsule; not an individual's count, frequency, conversion or restart instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-06", "currentLabelDisplayed": false, "ndcDirectoryListed": false, "marketAvailability": "historical_discontinued_brand", "marketingStartDate": null, "marketingEndDate": "2023-04-30", "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 30, "unit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "physicalClues": { "color": { "zh": "粉红色不透明", "en": "pink opaque" }, "shape": { "zh": "硬明胶胶囊，约 18 mm，无刻痕", "en": "hard-gelatin capsule, approximately 18 mm, unscored" }, "imprint": "GAL;16", "scoreStatus": "capsule_not_a_split_tablet", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_494a865c97459a50", "label": "DailyMed（NLM）：RAZADYNE／RAZADYNE ER 美国历史品牌标签（Janssen；SPL v25；生效日 2022-10-11）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ec9b5a9c-8caf-4f9b-8c1b-209b2de556dc", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-06", "reviewedAt": "2026-09-06" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-razadyne-galantamine-er-capsule-24mg-30-count-ndc-5045838930", "marketCode": "US", "labelVersion": { "zh": "DailyMed 美国历史品牌标签（SPL v25；2022-10-11 生效）；FDA 2025 审评资料确认品牌申请已停止销售", "en": "Historical U.S. DailyMed brand label (SPL v25; effective 11 Oct 2022); FDA's 2025 review confirms the brand applications are discontinued" }, "dosageForm": { "zh": "RAZADYNE ER 氢溴酸加兰他敏缓释胶囊", "en": "RAZADYNE ER galantamine hydrobromide extended-release capsule" }, "route": { "zh": "口服；历史品牌产品身份字段", "en": "oral; historical brand product-identity field" }, "routeCodes": [ "oral" ], "productCode": "NDC 50458-389-30", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_capsule", "primaryDisplay": { "zh": "每粒相当于加兰他敏 24 mg（以氢溴酸加兰他敏 30.76 mg 提供）；30 粒瓶装；历史品牌条目已停止销售", "en": "Equivalent to galantamine 24 mg per capsule (supplied as galantamine hydrobromide 30.76 mg); 30-count bottle; historical brand listing discontinued" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=razadyne-16.jpg&archiveid=673830", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "加兰他敏（以氢溴酸加兰他敏提供）", "en": "galantamine (supplied as galantamine hydrobromide)" }, "value": 24, "unit": "mg", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒标签标示量；不是个人粒数、频率、换算或重新开始指令", "en": "labelled amount per capsule; not an individual's count, frequency, conversion or restart instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-06", "currentLabelDisplayed": false, "ndcDirectoryListed": false, "marketAvailability": "historical_discontinued_brand", "marketingStartDate": null, "marketingEndDate": "2023-05-31", "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 30, "unit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "physicalClues": { "color": { "zh": "焦糖棕色不透明", "en": "caramel brown opaque" }, "shape": { "zh": "硬明胶胶囊，约 19 mm，无刻痕", "en": "hard-gelatin capsule, approximately 19 mm, unscored" }, "imprint": "GAL;24", "scoreStatus": "capsule_not_a_split_tablet", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_494a865c97459a50", "label": "DailyMed（NLM）：RAZADYNE／RAZADYNE ER 美国历史品牌标签（Janssen；SPL v25；生效日 2022-10-11）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ec9b5a9c-8caf-4f9b-8c1b-209b2de556dc", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-06", "reviewedAt": "2026-09-06" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-razadyne-galantamine-tablet-4mg-60-count-ndc-5045839660", "marketCode": "US", "labelVersion": { "zh": "DailyMed 美国历史品牌标签（SPL v25；2022-10-11 生效）；FDA 2025 审评资料确认品牌申请已停止销售", "en": "Historical U.S. DailyMed brand label (SPL v25; effective 11 Oct 2022); FDA's 2025 review confirms the brand applications are discontinued" }, "dosageForm": { "zh": "RAZADYNE 氢溴酸加兰他敏薄膜衣普通片", "en": "RAZADYNE galantamine hydrobromide immediate-release film-coated tablet" }, "route": { "zh": "口服；历史品牌产品身份字段", "en": "oral; historical brand product-identity field" }, "routeCodes": [ "oral" ], "productCode": "NDC 50458-396-60", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片相当于加兰他敏 4 mg；60 片瓶装；历史品牌条目已停止销售", "en": "Equivalent to galantamine 4 mg per tablet; 60-count bottle; historical brand listing discontinued" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=razadyne-17.jpg&archiveid=673830", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "加兰他敏（以氢溴酸加兰他敏提供）", "en": "galantamine (supplied as galantamine hydrobromide)" }, "value": 4, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、频率、换算或重新开始指令", "en": "labelled amount per tablet; not an individual's count, frequency, conversion or restart instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 60, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-06", "currentLabelDisplayed": false, "ndcDirectoryListed": false, "marketAvailability": "historical_discontinued_brand", "marketingStartDate": null, "marketingEndDate": "2020-09-30", "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 60, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "类白色", "en": "off-white" }, "shape": { "zh": "圆形双凸薄膜衣片，约 5 mm，无刻痕", "en": "round biconvex film-coated tablet, approximately 5 mm, unscored" }, "imprint": "JANSSEN;G;4", "scoreStatus": "unscored_do_not_split", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_494a865c97459a50", "label": "DailyMed（NLM）：RAZADYNE／RAZADYNE ER 美国历史品牌标签（Janssen；SPL v25；生效日 2022-10-11）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ec9b5a9c-8caf-4f9b-8c1b-209b2de556dc", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-06", "reviewedAt": "2026-09-06" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-razadyne-galantamine-tablet-8mg-60-count-ndc-5045839760", "marketCode": "US", "labelVersion": { "zh": "DailyMed 美国历史品牌标签（SPL v25；2022-10-11 生效）；FDA 2025 审评资料确认品牌申请已停止销售", "en": "Historical U.S. DailyMed brand label (SPL v25; effective 11 Oct 2022); FDA's 2025 review confirms the brand applications are discontinued" }, "dosageForm": { "zh": "RAZADYNE 氢溴酸加兰他敏薄膜衣普通片", "en": "RAZADYNE galantamine hydrobromide immediate-release film-coated tablet" }, "route": { "zh": "口服；历史品牌产品身份字段", "en": "oral; historical brand product-identity field" }, "routeCodes": [ "oral" ], "productCode": "NDC 50458-397-60", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片相当于加兰他敏 8 mg；60 片瓶装；历史品牌条目已停止销售", "en": "Equivalent to galantamine 8 mg per tablet; 60-count bottle; historical brand listing discontinued" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=razadyne-18.jpg&archiveid=673830", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "加兰他敏（以氢溴酸加兰他敏提供）", "en": "galantamine (supplied as galantamine hydrobromide)" }, "value": 8, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、频率、换算或重新开始指令", "en": "labelled amount per tablet; not an individual's count, frequency, conversion or restart instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 60, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-06", "currentLabelDisplayed": false, "ndcDirectoryListed": false, "marketAvailability": "historical_discontinued_brand", "marketingStartDate": null, "marketingEndDate": "2020-03-31", "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 60, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "粉红色", "en": "pink" }, "shape": { "zh": "圆形双凸薄膜衣片，约 7 mm，无刻痕", "en": "round biconvex film-coated tablet, approximately 7 mm, unscored" }, "imprint": "JANSSEN;G;8", "scoreStatus": "unscored_do_not_split", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_494a865c97459a50", "label": "DailyMed（NLM）：RAZADYNE／RAZADYNE ER 美国历史品牌标签（Janssen；SPL v25；生效日 2022-10-11）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ec9b5a9c-8caf-4f9b-8c1b-209b2de556dc", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-06", "reviewedAt": "2026-09-06" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-razadyne-galantamine-tablet-12mg-60-count-ndc-5045839860", "marketCode": "US", "labelVersion": { "zh": "DailyMed 美国历史品牌标签（SPL v25；2022-10-11 生效）；FDA 2025 审评资料确认品牌申请已停止销售", "en": "Historical U.S. DailyMed brand label (SPL v25; effective 11 Oct 2022); FDA's 2025 review confirms the brand applications are discontinued" }, "dosageForm": { "zh": "RAZADYNE 氢溴酸加兰他敏薄膜衣普通片", "en": "RAZADYNE galantamine hydrobromide immediate-release film-coated tablet" }, "route": { "zh": "口服；历史品牌产品身份字段", "en": "oral; historical brand product-identity field" }, "routeCodes": [ "oral" ], "productCode": "NDC 50458-398-60", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片相当于加兰他敏 12 mg；60 片瓶装；历史品牌条目已停止销售", "en": "Equivalent to galantamine 12 mg per tablet; 60-count bottle; historical brand listing discontinued" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=razadyne-19.jpg&archiveid=673830", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "加兰他敏（以氢溴酸加兰他敏提供）", "en": "galantamine (supplied as galantamine hydrobromide)" }, "value": 12, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、频率、换算或重新开始指令", "en": "labelled amount per tablet; not an individual's count, frequency, conversion or restart instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 60, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-06", "currentLabelDisplayed": false, "ndcDirectoryListed": false, "marketAvailability": "historical_discontinued_brand", "marketingStartDate": null, "marketingEndDate": "2020-03-31", "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 60, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "橙棕色", "en": "orange-brown" }, "shape": { "zh": "圆形双凸薄膜衣片，约 8 mm，无刻痕", "en": "round biconvex film-coated tablet, approximately 8 mm, unscored" }, "imprint": "JANSSEN;G;12", "scoreStatus": "unscored_do_not_split", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_494a865c97459a50", "label": "DailyMed（NLM）：RAZADYNE／RAZADYNE ER 美国历史品牌标签（Janssen；SPL v25；生效日 2022-10-11）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ec9b5a9c-8caf-4f9b-8c1b-209b2de556dc", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-06", "reviewedAt": "2026-09-06" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-razadyne-galantamine-er-capsule-16mg-30-count-ndc-5045838830", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=razadyne-15.jpg&archiveid=673830", "alt": "RAZADYNE ER 加兰他敏 16 mg、NDC 50458-388-30、30 粒历史瓶装在 DailyMed 标签中的准确展示面", "archiveMarket": "美国", "labelVersion": "DailyMed 历史品牌标签 SPL v25（2022-10-11 生效）；该 16 mg 包装营销结束日为 2023-04-30", "presentation": "RAZADYNE ER 每粒相当于加兰他敏 16 mg（氢溴酸盐 20.51 mg），粉红色 GAL 16 胶囊，30 粒瓶装。", "notice": "此图只对应一个已停止销售的美国历史品牌包装，用于核对品牌、剂型、每粒标示量、盐量、NDC 与瓶装数量；不用于鉴定真伪，不证明另一规格、普通片、口服液、当前库存、购买资格或可替代性。", "source": { "id": "src_494a865c97459a50", "label": "DailyMed（NLM）：RAZADYNE／RAZADYNE ER 美国历史品牌标签（Janssen；SPL v25；生效日 2022-10-11）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ec9b5a9c-8caf-4f9b-8c1b-209b2de556dc", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-06", "reviewedAt": "2026-09-06" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "RAZADYNE 说明书放大阅读：先分清普通片、口服液与 ER 缓释胶囊", "en": "RAZADYNE label reading: first separate immediate-release tablets, oral solution and ER capsules" }, "summary": { "zh": "历史品牌有三种口服剂型，当前美国通用名标签继续提供安全信息。这里把产品身份、包装数字、停用后重新开始、心率／晕厥、体重与胃肠反应放在一起阅读，但不生成个人剂量或换剂型方案。", "en": "The historical brand had three oral forms, while a current U.S. generic label continues to provide safety information. This section reads product identity, pack numbers, restarting after interruption, heart-rate/fainting, weight and gastrointestinal effects together, but generates no individual dose or formulation-switch plan." }, "checks": [ { "zh": "4、8、12 mg 普通片和 8、16、24 mg ER 缓释胶囊均按每片或每粒标示加兰他敏当量；瓶装 30 或 60 是包装数量，不是每天数量。标签中的氢溴酸盐质量与加兰他敏当量也不是两份药量。", "en": "The 4, 8 and 12 mg immediate-release tablets and 8, 16 and 24 mg ER capsules state galantamine equivalent per tablet or capsule. Bottle counts of 30 or 60 are pack quantities, not daily counts. Galantamine-hydrobromide mass and galantamine equivalent are not two medicine amounts." }, { "zh": "即使官方标签提供专业人员使用的普通片与 ER 转换信息，也不能据网页自己换剂型、拼接小规格或改变频次。ER 胶囊、普通片和口服液的释放方式、使用说明及包装身份不同。", "en": "Even though official labels contain clinician-directed conversion information between tablets and ER capsules, a webpage cannot authorise self-switching forms, assembling smaller strengths or changing frequency. ER capsules, immediate-release tablets and oral solution differ in release, instructions and product identity." }, { "zh": "当前通用名标签说明，中断超过三天后需要从最低剂量重新开始并再次逐步调整。这不是让患者自行重启的时间表：漏用多日、刚出院、呕吐脱水或照护交接后，应先联系开方团队或药师，不要直接恢复原来的服法。", "en": "The current generic label says interruption for more than three days requires restarting at the lowest dosage and re-titration. This is not a self-restart timetable: after several missed days, hospital discharge, vomiting/dehydration or a care transition, contact the prescriber or pharmacist before resuming the old routine." }, { "zh": "标签提示心动过缓与传导阻滞、晕厥、恶心呕吐腹泻、食欲下降和体重下降、胃肠出血、排尿梗阻、严重皮肤反应及哮喘／慢阻肺等风险。老人出现晕倒、跌倒、脉搏异常、持续呕吐腹泻、黑便／呕血、广泛皮疹起疱、呼吸困难或明显脱水，应及时寻求当地医疗帮助；严重急性表现使用急救。", "en": "The label describes bradycardia and heart block, syncope, nausea/vomiting/diarrhoea, reduced appetite and weight, gastrointestinal bleeding, urinary obstruction, serious skin reactions and concerns in asthma/COPD. In an older adult, fainting, falls, an abnormal pulse, persistent vomiting/diarrhoea, black stool/vomiting blood, widespread blistering rash, breathing difficulty or marked dehydration needs prompt local medical care; severe acute features require emergency help." } ], "source": { "id": "src_6ba86d4ee4280bda", "label": "DailyMed（NLM）：加兰他敏缓释胶囊当前美国通用名标签（2023-12 修订；2024-08-12 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=3059d10f-fb3d-4cbd-b936-104608889b67", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-06", "reviewedAt": "2026-09-06" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "加兰他敏怎样起作用：可逆抑制乙酰胆碱酯酶，不会改变痴呆病程", "en": "How galantamine works: reversible acetylcholinesterase inhibition does not alter the course of dementia" }, "summary": { "zh": "标签将加兰他敏描述为竞争性、可逆性乙酰胆碱酯酶抑制剂，通过增加胆碱能功能解释其药理作用，同时明确没有证据证明它改变基础痴呆过程。机制不能替代诊断、获益评估或照护计划。", "en": "The label describes galantamine as a competitive, reversible acetylcholinesterase inhibitor that enhances cholinergic function, while stating there is no evidence that it alters the underlying dementing process. Mechanism cannot replace diagnosis, benefit assessment or a care plan." }, "checks": [ { "zh": "多奈哌齐、利斯的明和加兰他敏同属胆碱酯酶抑制相关治疗，但不是可以按 mg 自行换算、交替或叠加的同一种药；美金刚机制又不同。发现重复或准备更换时，应先核对完整药单和准确产品。", "en": "Donepezil, rivastigmine and galantamine are related cholinesterase-inhibitor treatments but are not one medicine that can be self-converted by milligrams, alternated or combined; memantine has another mechanism. Review the full medicine list and exact products before addressing duplication or a switch." }, { "zh": "抗胆碱药可能对抗加兰他敏作用；其他胆碱酯酶抑制剂、胆碱能激动剂及麻醉中的某些神经肌肉阻滞药也需优先核对。就医或手术前应主动展示完整药单，不要根据网页自己错开或停药。", "en": "Anticholinergic medicines may oppose galantamine, while other cholinesterase inhibitors, cholinergic agonists and some neuromuscular blockers used in anaesthesia require priority review. Show the complete medicine list before care or surgery; do not self-separate or stop medicines from the page." }, { "zh": "CYP2D6 遗传差异可影响暴露，但标签并未把全基因组筛查写成所有人的前置要求，也未要求仅凭慢代谢者身份自动改量。遗传信息、肾肝功能、耐受性和相互作用须由负责团队结合实际问题解释。", "en": "CYP2D6 genetic variation can affect exposure, but the label does not require whole-genome screening for everyone or automatic dose changes from poor-metaboliser status alone. Genetic information, kidney/liver function, tolerability and interactions require interpretation by the responsible team for the actual question." } ], "source": { "id": "src_6ba86d4ee4280bda", "label": "DailyMed（NLM）：加兰他敏缓释胶囊当前美国通用名标签（2023-12 修订；2024-08-12 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=3059d10f-fb3d-4cbd-b936-104608889b67", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-06", "reviewedAt": "2026-09-06" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "RAZADYNE / RAZADYNE ER", "generic": "氢溴酸加兰他敏", "dosageFormClass": "历史品牌普通片 4/8/12 mg、缓释胶囊 8/16/24 mg；另有历史口服液申请，但本页尚未展示准确口服液包装面板" }, "labelSource": { "id": "src_6ba86d4ee4280bda", "label": "DailyMed（NLM）：加兰他敏缓释胶囊当前美国通用名标签（2023-12 修订；2024-08-12 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=3059d10f-fb3d-4cbd-b936-104608889b67", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-06", "reviewedAt": "2026-09-06" }, "productRoutes": [ { "source": { "id": "src_6ba86d4ee4280bda", "label": "DailyMed（NLM）：加兰他敏缓释胶囊当前美国通用名标签（2023-12 修订；2024-08-12 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=3059d10f-fb3d-4cbd-b936-104608889b67", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-06", "reviewedAt": "2026-09-06" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-09-06", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_494a865c97459a50", "label": "DailyMed（NLM）：RAZADYNE／RAZADYNE ER 美国历史品牌标签（Janssen；SPL v25；生效日 2022-10-11）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ec9b5a9c-8caf-4f9b-8c1b-209b2de556dc", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-06", "reviewedAt": "2026-09-06" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-09-06", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_91dc773613047682", "label": "FDA：RAZADYNE ER NDA 021615 2015 美国处方信息", "url": "https://www.accessdata.fda.gov/Drugsatfda_docs/Label/2015/021615s021lbl.Pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-06", "reviewedAt": "2026-09-06" }, "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-09-06", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-09-06", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "RAZADYNE 是加兰他敏历史品牌，最初也曾使用 REMINYL 名称。普通片、口服液和 ER 缓释胶囊不是只看总毫克数就能自行换算的同一种包装。网页展示六个历史品牌瓶装，帮助核对每片／每粒 mg、盐与活性成分的关系、颜色、刻字和 NDC；当前安全阅读则参考仍在更新的通用名标签。品牌档案已停止销售，不代表当前库存或购买入口。", "history": "美国普通片历史记录从 2001 年开始，RAZADYNE ER 于 2004 年进入营销记录。DailyMed 历史标签保留了三种普通片和三种缓释胶囊包装。FDA 2025 年审评资料把片剂、口服液和缓释胶囊三个品牌申请均描述为不再销售，并指出当前仍有仿制产品；因此本页把历史品牌身份、当前通用名安全信息和实时供应严格分开。", "sourceDocuments": [ { "id": "src_494a865c97459a50", "label": "DailyMed（NLM）：RAZADYNE／RAZADYNE ER 美国历史品牌标签（Janssen；SPL v25；生效日 2022-10-11）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ec9b5a9c-8caf-4f9b-8c1b-209b2de556dc", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-06", "reviewedAt": "2026-09-06" }, { "id": "src_6ba86d4ee4280bda", "label": "DailyMed（NLM）：加兰他敏缓释胶囊当前美国通用名标签（2023-12 修订；2024-08-12 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=3059d10f-fb3d-4cbd-b936-104608889b67", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-06", "reviewedAt": "2026-09-06" }, { "id": "src_3099cb020f71fe2e", "label": "FDA：加兰他敏片 NDA 021169 与 RAZADYNE ER NDA 021615 的 RLD／RS 及停止销售状态（2025 Chemistry Review）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2025/218549Orig1s000ChemR.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_review", "documentKind": "regulatory_review", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-06", "reviewedAt": "2026-09-06" }, { "id": "src_4b96b8d5a4ed0441", "label": "FDA：RAZADYNE 品牌片剂、口服液和缓释胶囊的申请史与停止销售说明（2025 Medical Review）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2025/218549Orig1s000MedR.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_review", "documentKind": "regulatory_review", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-06", "reviewedAt": "2026-09-06" }, { "id": "src_91dc773613047682", "label": "FDA：RAZADYNE ER NDA 021615 2015 美国处方信息", "url": "https://www.accessdata.fda.gov/Drugsatfda_docs/Label/2015/021615s021lbl.Pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-06", "reviewedAt": "2026-09-06" } ], "applicationNumber": "NDA 021169（普通片）／NDA 021224（口服液）／NDA 021615（ER 缓释胶囊）；历史品牌申请均已停止销售", "approvalTimeline": [ { "date": "2001-03-01", "title": { "zh": "RAZADYNE 普通片美国历史营销起始记录", "en": "Historical U.S. marketing-start record for RAZADYNE tablets" }, "detail": { "zh": "DailyMed 的 4、8、12 mg 普通片产品表均记录 NDA 021169 与 2001-03-01；FDA 2025 审评资料说明品牌片剂现已不再销售。", "en": "DailyMed product tables for 4, 8 and 12 mg tablets list NDA 021169 and 1 Mar 2001; FDA's 2025 review says the brand tablets are no longer marketed." }, "source": { "id": "src_494a865c97459a50", "label": "DailyMed（NLM）：RAZADYNE／RAZADYNE ER 美国历史品牌标签（Janssen；SPL v25；生效日 2022-10-11）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ec9b5a9c-8caf-4f9b-8c1b-209b2de556dc", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-06", "reviewedAt": "2026-09-06" } }, { "date": "2004-12-24", "title": { "zh": "RAZADYNE ER 美国历史营销起始记录", "en": "Historical U.S. marketing-start record for RAZADYNE ER" }, "detail": { "zh": "三种 ER 胶囊产品表均记录 NDA 021615 与 2004-12-24；品牌包装的营销结束日期分布在 2023-04 至 2023-05。", "en": "All three ER capsule product tables list NDA 021615 and 24 Dec 2004; brand-pack marketing end dates fall in Apr-May 2023." }, "source": { "id": "src_494a865c97459a50", "label": "DailyMed（NLM）：RAZADYNE／RAZADYNE ER 美国历史品牌标签（Janssen；SPL v25；生效日 2022-10-11）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ec9b5a9c-8caf-4f9b-8c1b-209b2de556dc", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-06", "reviewedAt": "2026-09-06" } }, { "date": "2025", "title": { "zh": "FDA 审评资料确认品牌剂型停止销售与 RLD／RS 身份", "en": "FDA review confirms discontinued brand forms and RLD/RS identities" }, "detail": { "zh": "Chemistry Review 将 4/8/12 mg 片剂与 8/16/24 mg ER 胶囊列为 RLD／RS 并注明停止销售；Medical Review 还说明口服液品牌申请也不再销售。", "en": "The Chemistry Review lists the 4/8/12 mg tablets and 8/16/24 mg ER capsules as RLD/RS and discontinued; the Medical Review also says the brand oral-solution application is no longer marketed." }, "source": { "id": "src_3099cb020f71fe2e", "label": "FDA：加兰他敏片 NDA 021169 与 RAZADYNE ER NDA 021615 的 RLD／RS 及停止销售状态（2025 Chemistry Review）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2025/218549Orig1s000ChemR.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_review", "documentKind": "regulatory_review", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-06", "reviewedAt": "2026-09-06" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "历史品牌剂型已停止销售；当前存在通用名标签记录", "en": "Historical brand forms discontinued; current generic label records exist" }, "detail": { "zh": "本页展示六张历史品牌准确包装图，同时链接当前通用名安全标签；二者不能混写为当前品牌库存、购买资格或自动替代关系。", "en": "The page shows six exact historical brand pack images and separately links a current generic safety label. They do not establish current brand stock, purchase eligibility or automatic substitution." } }, { "market": { "zh": "中国大陆、欧盟、日本及其他市场", "en": "Mainland China, EU, Japan and other markets" }, "status": { "zh": "待逐项建立准确市场产品记录", "en": "Exact market-product records not established" }, "detail": { "zh": "不从美国 RAZADYNE／REMINYL 名称、NDA、颜色、刻字或共同通用名推定当地商品名、批准、包装、供应、原研/仿制关系或可替代性。", "en": "No local trade name, approval, pack, supply, originator/generic relationship or interchangeability is inferred from the U.S. RAZADYNE/REMINYL names, NDA, colour, imprint or shared generic name." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "RAZADYNE ER 16 mg 可以用两粒 8 mg 自行替代吗？", "en": "Can two RAZADYNE ER 8 mg capsules self-replace one 16 mg capsule?" }, "answer": { "zh": "不能由网页授权。数字相加不等于处方、包装、可获得性和个体安全性相同；漏用多日或要变更规格时，先让药师或开方团队核对准确产品和计划。", "en": "A webpage cannot authorise this. Arithmetic does not establish an equivalent prescription, pack, availability or individual safety. After missed days or before a strength change, ask the pharmacist or prescriber to review the exact product and plan." } }, { "question": { "zh": "为什么包装写 16 mg，又写氢溴酸盐 20.51 mg？", "en": "Why does the pack say 16 mg and also 20.51 mg hydrobromide?" }, "answer": { "zh": "16 mg 是每粒所含加兰他敏活性成分当量；20.51 mg 是提供该当量所需的氢溴酸加兰他敏盐质量。它们是同一粒药的两种成分表示，不是相加成 36.51 mg，也不是两份药。", "en": "16 mg is the galantamine active-moiety equivalent per capsule; 20.51 mg is the mass of galantamine hydrobromide salt supplying it. They are two expressions for the same capsule, not 36.51 mg in total and not two doses." } }, { "question": { "zh": "加兰他敏和多奈哌齐、美金刚可以自己一起用或互换吗？", "en": "Can galantamine be self-combined or switched with donepezil or memantine?" }, "answer": { "zh": "不能。药物机制、剂型、相互作用和个体情况不同；网页只提示药单核对，不提供合用、停用、换药或时间安排。请由熟悉病史和完整药单的专业人员判断。", "en": "No. Mechanisms, dosage forms, interactions and individual circumstances differ. The site only prompts medicine-list review and provides no combination, stopping, switching or timing plan. A professional familiar with the history and complete list should decide." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "dosage-forms-are-part-of-medicine-identity", "how-to-read-a-drug-label", "generic-drugs-and-bioequivalence" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/razadyne-galantamine/", "en": "https://origindrug.com/en/drugs/razadyne-galantamine/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "lopressor", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-09-04", "status": "published_traceable_archive" }, "names": { "brand": "LOPRESSOR", "generic": "酒石酸美托洛尔", "aliases": [ "LOPRESSOR", "Lopressor", "倍他乐克", "倍他乐克平片", "美托洛尔普通片", "酒石酸美托洛尔", "metoprolol tartrate", "immediate-release metoprolol", "NDA 218698", "30698-460-03", "30698-460-01", "30698-460-10", "arrowhead E", "metoprolol immediate release" ], "marketBrandNames": [ { "name": "倍他乐克®平片", "market": { "zh": "中国大陆（企业公开产品列表）", "en": "Mainland China (company public product list)" }, "evidenceStatus": "publication_status_unresolved", "note": { "zh": "阿斯利康中国列表对应酒石酸美托洛尔片 25、50、100 mg；这只是名称与规格检索线索，不能与美国 LOPRESSOR 酒石酸美托洛尔 12.5 mg 按片数或 mg 自行换算。", "en": "AstraZeneca China's list maps the name to metoprolol tartrate tablets 25, 50 and 100 mg. This is a name-and-strength lookup cue only and cannot be self-converted by tablet count or milligrams with U.S. LOPRESSOR metoprolol tartrate 12.5 mg." }, "source": { "id": "src_74aa269ebb2ff692", "label": "阿斯利康中国：倍他乐克®平片（酒石酸美托洛尔片）产品列表", "url": "https://www.astrazeneca.com.cn/zh/our-focus-areas/cvm.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "first_party_product_page", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" } } ], "mainlandChinaTradeNameCue": { "value": "倍他乐克®平片", "status": "discovery_cue_requires_target_market_verification", "source": { "id": "src_74aa269ebb2ff692", "label": "阿斯利康中国：倍他乐克®平片（酒石酸美托洛尔片）产品列表", "url": "https://www.astrazeneca.com.cn/zh/our-focus-areas/cvm.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "first_party_product_page", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" } } }, "identity": { "therapeuticArea": "心血管", "sourceArchiveMarket": "美国当前 12.5 mg 片：NDA 218698、三个 NDC 瓶装与 2026-01-26 更新的 DailyMed 标签；美国历史 50 mg／100 mg 片：NDA 017963 的 2023 标签档案；中国大陆倍他乐克®平片：阿斯利康中国公开产品列表只提供 25、50、100 mg 名称与规格线索。三条资料按市场、NDA、规格和日期分开，不推定实时供应、价格、真伪或可替代性。", "dosageFormClass": "当前美国 NDA 218698 为酒石酸美托洛尔 12.5 mg 无刻痕薄膜衣普通片，分别为 30、60、1000 片瓶装；不得与历史 50/100 mg 片、LOPRESSOR 口服液、LOPRESSOR HCT、注射剂或 TOPROL-XL 缓释片合并换算。", "dosageFormClassCode": "oral_modified_release", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "2025-08-28（当前 12.5 mg 片 NDA 218698 批准函）；历史 LOPRESSOR 片另见 NDA 017963", "archiveSponsorText": "XTM Consulting LLC（NDA 218698 批准函申请方）；Validus Pharmaceuticals LLC（当前 DailyMed 标签分销方）" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [ "LOPRESSOR metoprolol tartrate tablets", "酒石酸美托洛尔片", "倍他乐克", "倍他乐克平片" ], "excludedProductCues": [ "TOPROL-XL", "metoprolol succinate", "extended-release metoprolol", "琥珀酸美托洛尔缓释片", "倍他乐克缓释片", "LOPRESSOR oral solution", "metoprolol injection", "LOPRESSOR HCT" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-lopressor-metoprolol-tartrate-tablet-12-5mg-30bottle-ndc-30698-460-03", "marketCode": "US", "labelVersion": { "zh": "DailyMed 美国标签（SPL v3；2026-01-26 更新）", "en": "U.S. DailyMed label (SPL v3; updated 26 Jan 2026)" }, "dosageForm": { "zh": "LOPRESSOR 酒石酸美托洛尔 12.5 mg 薄膜衣口服片", "en": "LOPRESSOR metoprolol tartrate 12.5 mg film-coated oral tablet" }, "route": { "zh": "口服（产品身份字段）", "en": "oral (product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 30698-460-03", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片酒石酸美托洛尔 12.5 mg；30 片瓶装", "en": "Metoprolol tartrate 12.5 mg per tablet; 30-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=metoprolol-tartrate-30-tablets.jpg&setid=b5f4fed2-369c-4808-a682-8a5b8cfdbb4f&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "酒石酸美托洛尔", "en": "metoprolol tartrate" }, "value": 12.5, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、频率或普通片／缓释片换算指令", "en": "labelled amount per tablet; not an individual tablet count, frequency or standard/extended-release conversion instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-04", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "current_label_listing_not_live_stock", "marketingStartDate": "2025-08-11", "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 30, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "粉红色", "en": "pink" }, "shape": { "zh": "5 mm 圆形、双凸、薄膜衣片", "en": "5 mm round, biconvex, film-coated tablet" }, "imprint": { "zh": "一面为箭头形标记与 E，另一面无文字", "en": "arrowhead mark and E on one side; plain on the other" }, "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_3340fc2eb1197d8a", "label": "DailyMed（NLM）：LOPRESSOR 酒石酸美托洛尔 12.5 mg 美国标签（SPL v3；2026-01-26 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b5f4fed2-369c-4808-a682-8a5b8cfdbb4f", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-lopressor-metoprolol-tartrate-tablet-12-5mg-60bottle-ndc-30698-460-01", "marketCode": "US", "labelVersion": { "zh": "DailyMed 美国标签（SPL v3；2026-01-26 更新）", "en": "U.S. DailyMed label (SPL v3; updated 26 Jan 2026)" }, "dosageForm": { "zh": "LOPRESSOR 酒石酸美托洛尔 12.5 mg 薄膜衣口服片", "en": "LOPRESSOR metoprolol tartrate 12.5 mg film-coated oral tablet" }, "route": { "zh": "口服（产品身份字段）", "en": "oral (product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 30698-460-01", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片酒石酸美托洛尔 12.5 mg；60 片瓶装", "en": "Metoprolol tartrate 12.5 mg per tablet; 60-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=metoprolol-tartrate-60-tablets.jpg&setid=b5f4fed2-369c-4808-a682-8a5b8cfdbb4f&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "酒石酸美托洛尔", "en": "metoprolol tartrate" }, "value": 12.5, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、频率或普通片／缓释片换算指令", "en": "labelled amount per tablet; not an individual tablet count, frequency or standard/extended-release conversion instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 60, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-04", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "current_label_listing_not_live_stock", "marketingStartDate": "2026-01-25", "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 60, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "粉红色", "en": "pink" }, "shape": { "zh": "5 mm 圆形、双凸、薄膜衣片", "en": "5 mm round, biconvex, film-coated tablet" }, "imprint": { "zh": "一面为箭头形标记与 E，另一面无文字", "en": "arrowhead mark and E on one side; plain on the other" }, "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_3340fc2eb1197d8a", "label": "DailyMed（NLM）：LOPRESSOR 酒石酸美托洛尔 12.5 mg 美国标签（SPL v3；2026-01-26 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b5f4fed2-369c-4808-a682-8a5b8cfdbb4f", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-lopressor-metoprolol-tartrate-tablet-12-5mg-1000bottle-ndc-30698-460-10", "marketCode": "US", "labelVersion": { "zh": "DailyMed 美国标签（SPL v3；2026-01-26 更新）", "en": "U.S. DailyMed label (SPL v3; updated 26 Jan 2026)" }, "dosageForm": { "zh": "LOPRESSOR 酒石酸美托洛尔 12.5 mg 薄膜衣口服片", "en": "LOPRESSOR metoprolol tartrate 12.5 mg film-coated oral tablet" }, "route": { "zh": "口服（产品身份字段）", "en": "oral (product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 30698-460-10", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片酒石酸美托洛尔 12.5 mg；1000 片瓶装", "en": "Metoprolol tartrate 12.5 mg per tablet; 1000-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=metoprolol-tartrate-1000-tablets.jpg&setid=b5f4fed2-369c-4808-a682-8a5b8cfdbb4f&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "酒石酸美托洛尔", "en": "metoprolol tartrate" }, "value": 12.5, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、频率或普通片／缓释片换算指令", "en": "labelled amount per tablet; not an individual tablet count, frequency or standard/extended-release conversion instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 1000, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-04", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "current_label_listing_not_live_stock", "marketingStartDate": "2025-08-11", "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 1000, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "粉红色", "en": "pink" }, "shape": { "zh": "5 mm 圆形、双凸、薄膜衣片", "en": "5 mm round, biconvex, film-coated tablet" }, "imprint": { "zh": "一面为箭头形标记与 E，另一面无文字", "en": "arrowhead mark and E on one side; plain on the other" }, "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_3340fc2eb1197d8a", "label": "DailyMed（NLM）：LOPRESSOR 酒石酸美托洛尔 12.5 mg 美国标签（SPL v3；2026-01-26 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b5f4fed2-369c-4808-a682-8a5b8cfdbb4f", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-lopressor-metoprolol-tartrate-tablet-12-5mg-30bottle-ndc-30698-460-03", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=metoprolol-tartrate-30-tablets.jpg&setid=b5f4fed2-369c-4808-a682-8a5b8cfdbb4f&type=img", "alt": "LOPRESSOR 酒石酸美托洛尔 12.5 mg、NDC 30698-460-03、30 片瓶装的 DailyMed 官方标签面板", "archiveMarket": "美国", "labelVersion": "DailyMed SPL v3（2026-01-26 更新）", "presentation": "LOPRESSOR 酒石酸美托洛尔 12.5 mg；NDC 30698-460-03；30 片瓶装。", "notice": "此图只对应当前美国标签中的一个准确瓶装面板。另有 60 片和 1000 片瓶装，均须按各自 NDC 核对；它不用于鉴定真伪，也不能证明实时库存、购买资格、历史 50/100 mg 产品或其他市场产品身份。", "source": { "id": "src_3340fc2eb1197d8a", "label": "DailyMed（NLM）：LOPRESSOR 酒石酸美托洛尔 12.5 mg 美国标签（SPL v3；2026-01-26 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b5f4fed2-369c-4808-a682-8a5b8cfdbb4f", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "LOPRESSOR 说明书放大阅读：先分清当前 12.5 mg 普通片、历史片剂和缓释片", "en": "Enlarged LOPRESSOR label: separate the current 12.5 mg standard tablet, historical tablets and extended release" }, "summary": { "zh": "这一阅读模块围绕当前 NDA 218698 的 12.5 mg 无刻痕普通片，不把旧 50/100 mg 标签、口服液、复方、注射剂或缓释片的文字搬到当前产品。", "en": "This reading module is limited to the current NDA 218698 12.5 mg unscored standard tablet. It does not transfer wording from historical 50/100 mg tablets, oral solution, combination, injection or extended-release products." }, "checks": [ { "zh": "12.5 mg 是每片标签标示量，30、60 或 1000 是每瓶片数；这些数字都不是某个人一天吃几片、是否掰开或怎样换成另一种美托洛尔的答案。", "en": "The 12.5 mg figure is the labelled amount per tablet, while 30, 60 or 1,000 is the bottle count. None answers an individual's daily tablet count, splitting question or conversion to another metoprolol product." }, { "zh": "标签将该片描述为无刻痕。无刻痕不等于网页可以直接给出“绝对不能掰”或“可以对半”的结论；应依据准确药盒、处方与药师/开方团队确认。", "en": "The label describes this tablet as unscored. That alone does not let a webpage declare that splitting is always prohibited or acceptable; use the exact pack, prescription and pharmacist/prescriber review." }, { "zh": "突然停用可能加重心肌缺血。不要因为心率、血压、头晕或一次漏用而自行停药、补服、减量、隔天用或与缓释片交替。", "en": "Abrupt cessation may worsen myocardial ischaemia. Do not self-stop, make up, reduce, alternate days or rotate with an extended-release tablet because of a pulse, blood-pressure value, dizziness or one missed use." }, { "zh": "心率过慢、低血压、晕厥、跌倒、呼吸困难、心衰加重或胸痛需要及时联系当地医疗团队；急重症状使用当地急救渠道。", "en": "Bradycardia, hypotension, syncope, a fall, breathing difficulty, worsening heart failure or chest pain needs timely local clinical review; use local emergency pathways for severe symptoms." }, { "zh": "糖尿病患者、禁食或呕吐者要注意：标签提示 β 阻滞剂可能掩盖心动过速等低血糖警示。不要只依赖心率判断是否低血糖。", "en": "For diabetes, fasting or vomiting, the label warns that beta blockers may mask signs of hypoglycaemia such as tachycardia. Do not rely on pulse alone to judge hypoglycaemia." }, { "zh": "手术或牙科操作前，应告知团队正在使用 LOPRESSOR；不要据网页自行提前停用。", "en": "Tell the surgical or dental team about LOPRESSOR. Do not stop it in advance based on a webpage." } ], "source": { "id": "src_3340fc2eb1197d8a", "label": "DailyMed（NLM）：LOPRESSOR 酒石酸美托洛尔 12.5 mg 美国标签（SPL v3；2026-01-26 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b5f4fed2-369c-4808-a682-8a5b8cfdbb4f", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "酒石酸美托洛尔怎样起作用：以 β1 受体阻断为主，但选择性不是绝对", "en": "How metoprolol tartrate works: mainly beta-1 blockade, but selectivity is not absolute" }, "summary": { "zh": "标签把美托洛尔描述为以 β1 肾上腺素能受体为主的阻断剂，可减慢窦性心率并影响房室结传导；较高暴露下也可能影响 β2 受体。这解释了心率、血压、呼吸和联用核对的重要性，但不能产生个人处方。", "en": "The label describes metoprolol as a predominantly beta-1 adrenergic blocker that slows sinus rate and affects AV-nodal conduction; at higher exposure it may also affect beta-2 receptors. This explains why pulse, blood pressure, breathing and co-medications matter, but it cannot generate an individual prescription." }, "checks": [ { "zh": "普通片与缓释片的释放方式不同；相同活性成分词根或相近 mg 不建立自行换算、叠加或轮换关系。", "en": "Standard and extended-release tablets have different release designs. A shared active-ingredient root or similar milligrams creates no self-conversion, combination or rotation rule." }, { "zh": "不同 NDA、剂型、规格、辅料与市场标签都属于产品身份；作用机理相似不能证明原研关系、真伪、可售资格或个人适用性。", "en": "Different NDAs, dosage forms, strengths, excipients and market labels are product-identity fields. Similar mechanisms cannot prove originator status, authenticity, sale eligibility or individual suitability." }, { "zh": "心率、血压、糖代谢、呼吸系统情况和其他减慢心率药物都会改变专业人员需要核对的风险；机理说明不能决定个人是否开始、继续、减量或停用。", "en": "Pulse, blood pressure, glucose regulation, respiratory status and other heart-rate-slowing medicines all affect the risks a professional needs to review; a mechanism explanation cannot decide whether an individual should start, continue, reduce or stop treatment." } ], "source": { "id": "src_3340fc2eb1197d8a", "label": "DailyMed（NLM）：LOPRESSOR 酒石酸美托洛尔 12.5 mg 美国标签（SPL v3；2026-01-26 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b5f4fed2-369c-4808-a682-8a5b8cfdbb4f", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "LOPRESSOR", "generic": "酒石酸美托洛尔", "dosageFormClass": "当前美国 NDA 218698 为酒石酸美托洛尔 12.5 mg 无刻痕薄膜衣普通片，分别为 30、60、1000 片瓶装；不得与历史 50/100 mg 片、LOPRESSOR 口服液、LOPRESSOR HCT、注射剂或 TOPROL-XL 缓释片合并换算。" }, "labelSource": { "id": "src_3340fc2eb1197d8a", "label": "DailyMed（NLM）：LOPRESSOR 酒石酸美托洛尔 12.5 mg 美国标签（SPL v3；2026-01-26 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b5f4fed2-369c-4808-a682-8a5b8cfdbb4f", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" }, "productRoutes": [ { "source": { "id": "src_3340fc2eb1197d8a", "label": "DailyMed（NLM）：LOPRESSOR 酒石酸美托洛尔 12.5 mg 美国标签（SPL v3；2026-01-26 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b5f4fed2-369c-4808-a682-8a5b8cfdbb4f", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-09-04", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_2f9e041472de1f78", "label": "DailyMed（NLM）：LOPRESSOR 酒石酸美托洛尔 12.5 mg 美国电子说明书 PDF", "url": "https://dailymed.nlm.nih.gov/dailymed/downloadpdffile.cfm?setId=b5f4fed2-369c-4808-a682-8a5b8cfdbb4f", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-09-04", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_1003d2645bc095e8", "label": "FDA：LOPRESSOR 酒石酸美托洛尔 50 mg／100 mg 片 NDA 017963 标签档案（2023；历史产品）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/017693s076lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" }, "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-09-04", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-09-04", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "当前美国 LOPRESSOR 12.5 mg 片属于 NDA 218698，与历史 50/100 mg LOPRESSOR 片、口服液、复方 LOPRESSOR HCT，以及 TOPROL-XL 缓释片不是同一个产品身份。老人或同时使用多种心率、血压药物者，应重点核对心率过慢、低血压、头晕跌倒、呼吸困难、低血糖症状被掩盖和突然停药风险；网页不提供个人片数、频率、减量、停用或普通片／缓释片转换方案。", "history": "FDA 于 2025-08-28 批准 NDA 218698 的 LOPRESSOR 酒石酸美托洛尔 12.5 mg 片，用于血流动力学稳定的成人心肌梗死患者相关标签用途。DailyMed 当前记录列出 NDC 30698-460-03、-01、-10 和三个瓶装，并在标签抬头保留“Initial U.S. Approval: 1992”；另有 FDA 资料显示历史 LOPRESSOR 50/100 mg 片归于 NDA 017963。本站同时展示这些字段，但不把标签抬头年份误写成当前 NDA 218698 的批准日期。", "sourceDocuments": [ { "id": "src_3340fc2eb1197d8a", "label": "DailyMed（NLM）：LOPRESSOR 酒石酸美托洛尔 12.5 mg 美国标签（SPL v3；2026-01-26 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b5f4fed2-369c-4808-a682-8a5b8cfdbb4f", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" }, { "id": "src_2f9e041472de1f78", "label": "DailyMed（NLM）：LOPRESSOR 酒石酸美托洛尔 12.5 mg 美国电子说明书 PDF", "url": "https://dailymed.nlm.nih.gov/dailymed/downloadpdffile.cfm?setId=b5f4fed2-369c-4808-a682-8a5b8cfdbb4f", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" }, { "id": "src_cbf19b6cb915e288", "label": "FDA：LOPRESSOR 酒石酸美托洛尔 12.5 mg 片 NDA 218698 批准函（2025-08-28）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/218698Orig1s000ltr.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "approval_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" }, { "id": "src_1003d2645bc095e8", "label": "FDA：LOPRESSOR 酒石酸美托洛尔 50 mg／100 mg 片 NDA 017963 标签档案（2023；历史产品）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/017693s076lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" }, { "id": "src_74aa269ebb2ff692", "label": "阿斯利康中国：倍他乐克®平片（酒石酸美托洛尔片）产品列表", "url": "https://www.astrazeneca.com.cn/zh/our-focus-areas/cvm.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "first_party_product_page", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" } ], "applicationNumber": "NDA 218698（当前 12.5 mg 片）；NDA 017963（历史 50/100 mg 片档案）", "approvalTimeline": [ { "date": "1978-08-07", "title": { "zh": "历史 LOPRESSOR 片 NDA 017963 获批", "en": "Legacy LOPRESSOR tablet NDA 017963 approved" }, "detail": { "zh": "FDA 公开审评资料将历史 LOPRESSOR 片与该日期和 NDA 017963 相连；本页以 2023 标签档案保留 50/100 mg 历史，不把它当成当前 12.5 mg 包装。", "en": "FDA public review material links legacy LOPRESSOR tablets to this date and NDA 017963. This page preserves the 50/100 mg history through the 2023 label archive without treating it as the current 12.5 mg pack." }, "source": { "id": "src_1003d2645bc095e8", "label": "FDA：LOPRESSOR 酒石酸美托洛尔 50 mg／100 mg 片 NDA 017963 标签档案（2023；历史产品）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/017693s076lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" } }, { "date": "2025-08-28", "title": { "zh": "当前 12.5 mg LOPRESSOR 片 NDA 218698 获批", "en": "Current 12.5 mg LOPRESSOR tablet NDA 218698 approved" }, "detail": { "zh": "FDA 批准函确认这是 505(b)(2) 申请，批准用途限于函件和标签所述的血流动力学稳定成人心肌梗死情形。", "en": "The FDA approval letter confirms a 505(b)(2) application, with the approved use limited to the haemodynamically stable adult myocardial-infarction setting described in the letter and label." }, "source": { "id": "src_cbf19b6cb915e288", "label": "FDA：LOPRESSOR 酒石酸美托洛尔 12.5 mg 片 NDA 218698 批准函（2025-08-28）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/218698Orig1s000ltr.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "approval_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" } }, { "date": "2026-01-26", "title": { "zh": "DailyMed 当前标签更新", "en": "Current DailyMed label updated" }, "detail": { "zh": "当前标签列出 12.5 mg、三个 NDC 瓶装、外观、辅料和安全章节。", "en": "The current label lists 12.5 mg, three NDC bottle presentations, appearance, excipients and safety sections." }, "source": { "id": "src_3340fc2eb1197d8a", "label": "DailyMed（NLM）：LOPRESSOR 酒石酸美托洛尔 12.5 mg 美国标签（SPL v3；2026-01-26 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b5f4fed2-369c-4808-a682-8a5b8cfdbb4f", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" } } ], "marketStatus": [ { "market": { "zh": "美国当前 12.5 mg 片", "en": "Current U.S. 12.5 mg tablet" }, "status": { "zh": "NDA 218698；三个公开标签瓶装", "en": "NDA 218698; three public-label bottle presentations" }, "detail": { "zh": "NDC 30698-460-03（30 片）、-01（60 片）、-10（1000 片）；目录字段不等于实时库存。", "en": "NDC 30698-460-03 (30), -01 (60) and -10 (1,000 tablets); directory fields are not live stock." } }, { "market": { "zh": "美国历史 50/100 mg 片", "en": "Legacy U.S. 50/100 mg tablets" }, "status": { "zh": "NDA 017963 历史标签另存", "en": "NDA 017963 retained as a separate historical label" }, "detail": { "zh": "不得将旧适应症、刻痕、外观、剂量文字或包装迁移到当前 12.5 mg 产品。", "en": "Do not transfer legacy indications, scoring, appearance, dosage wording or packs to the current 12.5 mg product." } }, { "market": { "zh": "中国大陆倍他乐克®平片", "en": "Mainland China Betaloc standard tablets" }, "status": { "zh": "企业产品列表名称与规格线索", "en": "Company product-list name and strength cues" }, "detail": { "zh": "25、50、100 mg；当前批准文号、完整说明书与包装仍须按中国监管来源逐项核验。", "en": "25, 50 and 100 mg; current approval numbers, full labels and packs still require item-by-item Chinese regulatory verification." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "标签为什么写 1992，FDA 批准函却是 2025？", "en": "Why does the label say 1992 while the FDA approval letter is dated 2025?" }, "answer": { "zh": "两者不是同一个字段。当前标签抬头保留 Initial U.S. Approval: 1992，但当前 12.5 mg 片的申请号是 NDA 218698，批准函日期为 2025-08-28；更早的 LOPRESSOR 片还有 NDA 017963 历史。核对产品应优先使用准确 NDA、剂型、强度、NDC 和标签版本，不能只看一个年份。", "en": "They are not the same field. The current label heading retains Initial U.S. Approval: 1992, while the current 12.5 mg tablet is NDA 218698 with an approval letter dated 28 Aug 2025; earlier LOPRESSOR tablets also have an NDA 017963 history. Product identity requires the exact NDA, dosage form, strength, NDC and label version, not one year alone." } }, { "question": { "zh": "12.5 mg 无刻痕片能不能掰半？", "en": "Can the 12.5 mg unscored tablet be split?" }, "answer": { "zh": "网页不能从“无刻痕”单独推导出个人操作结论。请带实际药盒和处方询问药师或开方团队；不要用旧 50/100 mg 片、缓释片或另一厂家产品的做法替代。", "en": "A webpage cannot derive an individual handling instruction from the word unscored alone. Ask a pharmacist or prescriber with the actual pack and prescription; do not substitute instructions from legacy 50/100 mg tablets, extended-release tablets or another manufacturer." } }, { "question": { "zh": "LOPRESSOR 与 TOPROL-XL 都是美托洛尔，可以自行换吗？", "en": "LOPRESSOR and TOPROL-XL are both metoprolol. Can they be self-switched?" }, "answer": { "zh": "不能。盐型、普通/缓释设计、每单位含量、适应症、包装、标签和处方都要分别核对；相近 mg 不形成自行换算、叠加或轮换关系。", "en": "No. Salt, standard/extended-release design, amount per unit, indication, pack, label and prescription all require separate checking; similar milligrams create no self-conversion, combination or rotation rule." } } ], "relatedMedicineChecks": [ { "target": { "id": "toprol-xl", "brand": "Toprol-XL", "generic": "琥珀酸美托洛尔", "canonicalUrls": { "zh": "https://origindrug.com/drugs/toprol-xl/", "en": "https://origindrug.com/en/drugs/toprol-xl/" } }, "title": { "zh": "与 TOPROL-XL／琥珀酸美托洛尔缓释片同在药单上时", "en": "When TOPROL-XL / metoprolol succinate extended release is on the same list" }, "summary": { "zh": "LOPRESSOR 是酒石酸美托洛尔普通片，TOPROL-XL 是琥珀酸美托洛尔缓释片；共同出现“美托洛尔”只触发完整药单核对。本卡片不判断能否同用，也不建议自行停用、错开时间、替换或调整任何一种药。", "en": "LOPRESSOR is a standard metoprolol tartrate tablet, while TOPROL-XL is an extended-release metoprolol succinate tablet; they must be reviewed as distinct standard and extended-release tablets. A shared metoprolol name triggers a complete medicine-list review; this card does not decide co-use or advise self-stopping, time-separation, replacement or adjustment of either medicine." }, "source": { "id": "src_3340fc2eb1197d8a", "label": "DailyMed（NLM）：LOPRESSOR 酒石酸美托洛尔 12.5 mg 美国标签（SPL v3；2026-01-26 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b5f4fed2-369c-4808-a682-8a5b8cfdbb4f", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" }, "scope": "review_complete_medicine_list_no_self_directed_change" } ], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "dosage-forms-are-part-of-medicine-identity", "same-class-is-not-same-medicine", "interactions-are-not-a-home-scheduling-problem" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/lopressor/", "en": "https://origindrug.com/en/drugs/lopressor/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "flomax", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-09-04", "status": "published_traceable_archive" }, "names": { "brand": "FLOMAX", "generic": "坦索罗辛", "aliases": [ "Flomax", "tamsulosin", "tamsulosin hydrochloride", "tamsulosin hydrochloride capsules", "坦索罗辛", "盐酸坦索罗辛", "盐酸坦索罗辛胶囊", "NDA 020579", "0024-5837-01", "NDC 0024-5837-01", "BI 58", "Flomax 0 4 mg BI 58" ], "marketBrandNames": [ { "name": "FLOMAX", "market": { "zh": "美国历史品牌档案", "en": "U.S. historical brand archive" }, "evidenceStatus": "dated_brand_pack_marketing_ended", "note": { "zh": "NDA 020579；0.4 mg、NDC 0024-5837-01、100 粒瓶装；公开营销记录于 2025-10-31 结束。", "en": "NDA 020579; 0.4 mg, NDC 0024-5837-01, 100-capsule bottle; the public marketing record ended 31 Oct 2025." }, "source": { "id": "src_098d83b525ce2151", "label": "DailyMed（NLM）：FLOMAX 坦索罗辛盐酸盐 0.4 mg 美国品牌标签（SPL v10；2025-01-02 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=6771ad8e-ac92-4aec-b484-5d8350a353f8", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" } } ], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "泌尿健康", "sourceArchiveMarket": "美国官方资料将 FLOMAX 与 NDA 020579、坦索罗辛盐酸盐 0.4 mg 胶囊、NDC 0024-5837-01 和 100 粒瓶装相连。该品牌 NDC 的公开营销终止日期为 2025-10-31，因此本页保存的是有日期的品牌身份档案，不代表当前库存、可购买性、真伪或其他市场状态。", "dosageFormClass": "坦索罗辛盐酸盐普通口服硬胶囊 0.4 mg；0.4 mg 是每粒标签标示量，100 是所示品牌瓶内粒数。胶囊不得压碎、咀嚼或打开；这些字段不能变成个人服用、恢复、加量、停用或替换方案。", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "1997-04-15（美国 NDA 020579 原始批准日期）", "archiveSponsorText": "Boehringer Ingelheim Pharmaceuticals（美国 NDA 020579 品牌标签）" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [ "FLOMAX", "FLOMAX tamsulosin hydrochloride", "tamsulosin hydrochloride capsules", "盐酸坦索罗辛胶囊" ], "excludedProductCues": [ "UROXATRAL", "alfuzosin", "RAPAFLO", "silodosin", "HYTRIN", "terazosin", "CARDURA", "doxazosin", "MINIPRESS", "prazosin", "CIALIS", "tadalafil" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-flomax-tamsulosin-hydrochloride-0-4mg-100-capsule-bottle-ndc-0024583701", "marketCode": "US", "labelVersion": { "zh": "DailyMed 美国品牌标签（SPL v10；2025-01-02 生效）", "en": "U.S. DailyMed brand label (SPL v10; effective 2 Jan 2025)" }, "dosageForm": { "zh": "FLOMAX 坦索罗辛盐酸盐 0.4 mg 口服硬胶囊", "en": "FLOMAX tamsulosin hydrochloride 0.4 mg oral hard capsule" }, "route": { "zh": "口服（产品身份字段）", "en": "oral (product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 0024-5837-01", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_capsule", "primaryDisplay": { "zh": "每粒坦索罗辛盐酸盐 0.4 mg；100 粒瓶装", "en": "Tamsulosin hydrochloride 0.4 mg per capsule; 100-capsule bottle" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "坦索罗辛盐酸盐", "en": "tamsulosin hydrochloride" }, "value": 0.4, "unit": "mg", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒标签标示量；不是个人服用、恢复或加量指令", "en": "labelled amount per capsule; not an individual dosing, restart or escalation instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-04", "currentLabelDisplayed": false, "ndcDirectoryListed": true, "marketAvailability": "dated_brand_record_marketing_ended_not_live_stock", "marketingStartDate": null, "marketingEndDate": "2025-10-31", "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "physicalClues": { "color": { "zh": "橄榄绿色不透明胶囊帽、橙色不透明胶囊体", "en": "olive-green opaque cap and orange opaque body" }, "shape": { "zh": "19 mm 硬胶囊；无刻痕；胶囊不得压碎、咀嚼或打开", "en": "19 mm hard capsule; unscored; capsule must not be crushed, chewed or opened" }, "imprint": "Flomax; 0; 4; mg; BI; 58", "scoreStatus": "unscored_do_not_crush_chew_or_open", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_098d83b525ce2151", "label": "DailyMed（NLM）：FLOMAX 坦索罗辛盐酸盐 0.4 mg 美国品牌标签（SPL v10；2025-01-02 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=6771ad8e-ac92-4aec-b484-5d8350a353f8", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "status": "withheld_repackaged_or_non_exact_visual", "title": { "zh": "品牌文字身份完整，官方包装图片直链不可用", "en": "Brand text identity is complete; the official package-image endpoint was unusable" }, "summary": { "zh": "DailyMed 品牌标签列出 FLOMAX、NDA 020579、NDC 0024-5837-01、每粒 0.4 mg、100 粒瓶装、胶囊颜色、19 mm 尺寸及 BI 58 印记；但复核时官方包装图片直链未返回可用图像内容。本站因此仅展示文字身份，不以占位图、搜索图或再包装图代替，也不用于真伪、供应或购买判断。", "en": "The DailyMed brand label lists FLOMAX, NDA 020579, NDC 0024-5837-01, 0.4 mg per capsule, a 100-capsule bottle, capsule colours, 19 mm size and the BI 58 imprint; however, its official package-image endpoint returned no usable image content during review. The site therefore shows text identity only and does not substitute a placeholder, search image or repackaged image, or use it for authenticity, supply or purchase decisions." }, "source": { "id": "src_098d83b525ce2151", "label": "DailyMed（NLM）：FLOMAX 坦索罗辛盐酸盐 0.4 mg 美国品牌标签（SPL v10；2025-01-02 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=6771ad8e-ac92-4aec-b484-5d8350a353f8", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "FLOMAX 说明书放大阅读：0.4 mg、完整吞服、头晕跌倒与手术告知", "en": "Enlarged FLOMAX label: 0.4 mg, intact swallowing, dizziness/falls and surgical disclosure" }, "summary": { "zh": "本模块帮助识别每粒含量、胶囊完整性、体位性低血压、相互作用与眼科手术告知。标签中的用法与中断后恢复段落不转写为个人方案。", "en": "This module identifies per-capsule strength, capsule integrity, orthostatic hypotension, interactions and eye-surgery disclosure. Label dosing and restart paragraphs are not converted into an individual plan." }, "checks": [ { "zh": "标签将 FLOMAX 用于良性前列腺增生相关症状，并明确它不用于治疗高血压。排尿症状、头晕或“α 阻滞剂”字样都不能支持自行换药或叠加。", "en": "The label uses FLOMAX for signs and symptoms of benign prostatic hyperplasia and states that it is not indicated for hypertension. Urinary symptoms, dizziness or the words alpha blocker do not support self-switching or combining medicines." }, { "zh": "胶囊应保持完整，不得压碎、咀嚼或打开。0.4 mg 是每粒标签量，不是根据网页自行决定的起始、恢复、加量、漏服补服或停药规则。", "en": "The capsule should remain intact and must not be crushed, chewed or opened. The 0.4 mg figure is a labelled amount per capsule, not a website-derived rule for starting, restarting, increasing, replacing missed doses or stopping." }, { "zh": "起立时头晕、低血压或晕厥可能导致跌倒。老人、夜间起身者和同时使用其他影响血压药物者，应把准确药盒、症状和完整药单交给医生或药师核对。", "en": "Dizziness on standing, hypotension or syncope may lead to falls. Older adults, people rising at night and those using other blood-pressure-affecting medicines should have the exact pack, symptoms and complete medicine list reviewed by a clinician or pharmacist." }, { "zh": "白内障或青光眼手术前，应告知眼科团队现在或过去使用过坦索罗辛；标签同时说明，术前停用的获益尚未确立，不能据网页自行停药。", "en": "Before cataract or glaucoma surgery, tell the eye-care team about current or past tamsulosin use. The label also says the benefit of stopping before surgery has not been established, so do not stop it from a web page." }, { "zh": "晕厥、跌倒受伤或严重虚弱需要及时医疗评估；持续数小时的疼痛性勃起是急症信号，应立即使用当地急救渠道。", "en": "Syncope, an injurious fall or severe weakness needs timely medical assessment. A painful erection lasting hours is an emergency signal requiring immediate local emergency care." } ], "source": { "id": "src_098d83b525ce2151", "label": "DailyMed（NLM）：FLOMAX 坦索罗辛盐酸盐 0.4 mg 美国品牌标签（SPL v10；2025-01-02 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=6771ad8e-ac92-4aec-b484-5d8350a353f8", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "坦索罗辛怎样起作用：松弛前列腺与膀胱颈平滑肌，不等于缩小前列腺或治疗高血压", "en": "How tamsulosin works: relaxing prostate and bladder-neck smooth muscle does not shrink the prostate or treat hypertension" }, "summary": { "zh": "标签将坦索罗辛描述为 α1 肾上腺素能受体阻断剂，其作用可松弛前列腺和膀胱颈平滑肌、改善尿流。机理也解释体位性低血压边界，但不能选择个人剂量、联用或替代药。", "en": "The label describes tamsulosin as an alpha-1 adrenergic receptor blocker that can relax smooth muscle in the prostate and bladder neck and improve urine flow. The mechanism also helps explain orthostatic-hypotension boundaries but cannot select an individual dose, combination or substitute." }, "checks": [ { "zh": "FLOMAX、UROXATRAL、RAPAFLO、HYTRIN、CARDURA 和 MINIPRESS 是不同成分或产品。作用类别相关不建立 mg 换算、轮换、同服或替换规则。", "en": "FLOMAX, UROXATRAL, RAPAFLO, HYTRIN, CARDURA and MINIPRESS are different ingredients or products. Related pharmacology creates no milligram conversion, alternation, combination or substitution rule." }, { "zh": "它不缩小前列腺，也不用于高血压。作用机理不能代替症状评估、血压、跌倒史、手术计划和完整药单。", "en": "It does not shrink the prostate and is not indicated for hypertension. Mechanism cannot replace assessment of symptoms, blood pressure, falls, surgical plans and the complete medicine list." }, { "zh": "相同通用名也可能有不同厂家、辅料、包装、市场与标签日期；作用机理相同不能证明实物真伪、当前供应或可自行替代。", "en": "The same generic name can still have different manufacturers, excipients, packs, markets and label dates. A shared mechanism cannot prove authenticity, current supply or self-substitutability." } ], "source": { "id": "src_098d83b525ce2151", "label": "DailyMed（NLM）：FLOMAX 坦索罗辛盐酸盐 0.4 mg 美国品牌标签（SPL v10；2025-01-02 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=6771ad8e-ac92-4aec-b484-5d8350a353f8", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "FLOMAX", "generic": "坦索罗辛", "dosageFormClass": "坦索罗辛盐酸盐普通口服硬胶囊 0.4 mg；0.4 mg 是每粒标签标示量，100 是所示品牌瓶内粒数。胶囊不得压碎、咀嚼或打开；这些字段不能变成个人服用、恢复、加量、停用或替换方案。" }, "labelSource": { "id": "src_098d83b525ce2151", "label": "DailyMed（NLM）：FLOMAX 坦索罗辛盐酸盐 0.4 mg 美国品牌标签（SPL v10；2025-01-02 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=6771ad8e-ac92-4aec-b484-5d8350a353f8", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" }, "productRoutes": [ { "source": { "id": "src_098d83b525ce2151", "label": "DailyMed（NLM）：FLOMAX 坦索罗辛盐酸盐 0.4 mg 美国品牌标签（SPL v10；2025-01-02 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=6771ad8e-ac92-4aec-b484-5d8350a353f8", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-09-04", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_8c888fa3209fadb7", "label": "DailyMed（NLM）：FLOMAX 坦索罗辛盐酸盐品牌电子说明书 PDF", "url": "https://dailymed.nlm.nih.gov/dailymed/downloadpdffile.cfm?setId=6771ad8e-ac92-4aec-b484-5d8350a353f8", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-09-04", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-09-04", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "FLOMAX 是坦索罗辛盐酸盐的美国品牌历史档案，用于良性前列腺增生相关症状的标签阅读，不是降压药。老人、夜间起身者、有头晕、晕厥或跌倒史者，应特别核对体位性低血压、其他 α 阻滞剂、PDE5 抑制剂和强 CYP3A4 抑制剂；网页不提供个人起始、恢复、停药、加量或换药方案。", "history": "FDA 原始批准资料记录 FLOMAX NDA 020579 于 1997-04-15 获批。2014-09-29 的补充批准函记录 S-029 标签更新。DailyMed SPL v10 于 2025-01-02 生效，保留 0.4 mg、100 粒品牌瓶装及 BI 58 胶囊线索；该 NDC 的营销记录于 2025-10-31 结束。", "sourceDocuments": [ { "id": "src_098d83b525ce2151", "label": "DailyMed（NLM）：FLOMAX 坦索罗辛盐酸盐 0.4 mg 美国品牌标签（SPL v10；2025-01-02 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=6771ad8e-ac92-4aec-b484-5d8350a353f8", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" }, { "id": "src_8c888fa3209fadb7", "label": "DailyMed（NLM）：FLOMAX 坦索罗辛盐酸盐品牌电子说明书 PDF", "url": "https://dailymed.nlm.nih.gov/dailymed/downloadpdffile.cfm?setId=6771ad8e-ac92-4aec-b484-5d8350a353f8", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" }, { "id": "src_fcbe041e382b3a8a", "label": "FDA：FLOMAX（NDA 020579）1997 年原始批准资料包", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020579ap.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "approval_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" }, { "id": "src_ea3f4b403da307a4", "label": "FDA：FLOMAX NDA 020579/S-029 补充批准函（2014-09-29）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020579Orig1s029ltr.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "approval_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" } ], "applicationNumber": "NDA 020579", "approvalTimeline": [ { "date": "1997-04-15", "title": { "zh": "FDA 批准 FLOMAX NDA", "en": "FDA approval of the FLOMAX NDA" }, "detail": { "zh": "FDA 原始批准资料包记录 NDA 020579 的批准。", "en": "The FDA original approval package records approval of NDA 020579." }, "source": { "id": "src_fcbe041e382b3a8a", "label": "FDA：FLOMAX（NDA 020579）1997 年原始批准资料包", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020579ap.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "approval_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" } }, { "date": "2014-09-29", "title": { "zh": "FDA 批准 S-029 标签补充", "en": "FDA approval of the S-029 labelling supplement" }, "detail": { "zh": "补充批准函记录相应标签更新。", "en": "The supplement approval letter records the corresponding label update." }, "source": { "id": "src_ea3f4b403da307a4", "label": "FDA：FLOMAX NDA 020579/S-029 补充批准函（2014-09-29）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020579Orig1s029ltr.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "approval_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" } }, { "date": "2025-01-02", "title": { "zh": "DailyMed SPL v10 生效", "en": "DailyMed SPL v10 became effective" }, "detail": { "zh": "该版本保留 0.4 mg 品牌胶囊、100 粒瓶装和外观文字线索。", "en": "This version preserves the 0.4 mg brand capsule, 100-capsule bottle and textual appearance clues." }, "source": { "id": "src_098d83b525ce2151", "label": "DailyMed（NLM）：FLOMAX 坦索罗辛盐酸盐 0.4 mg 美国品牌标签（SPL v10；2025-01-02 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=6771ad8e-ac92-4aec-b484-5d8350a353f8", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" } }, { "date": "2025-10-31", "title": { "zh": "所示品牌 NDC 营销记录结束", "en": "Marketing record ended for the displayed brand NDC" }, "detail": { "zh": "这是监管目录字段，不等于全球停售，也不证明任何渠道库存。", "en": "This is a regulatory-listing field, not proof of global discontinuation or any channel's stock." }, "source": { "id": "src_098d83b525ce2151", "label": "DailyMed（NLM）：FLOMAX 坦索罗辛盐酸盐 0.4 mg 美国品牌标签（SPL v10；2025-01-02 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=6771ad8e-ac92-4aec-b484-5d8350a353f8", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" } } ], "marketStatus": [ { "market": { "zh": "美国 FLOMAX 品牌包装", "en": "U.S. FLOMAX brand pack" }, "status": { "zh": "所示 NDC 营销记录已结束", "en": "Marketing record ended for the displayed NDC" }, "detail": { "zh": "0.4 mg、NDC 0024-5837-01、100 粒瓶装；结束日期 2025-10-31。", "en": "0.4 mg, NDC 0024-5837-01, 100-capsule bottle; end date 31 Oct 2025." } }, { "market": { "zh": "其他厂家与市场", "en": "Other manufacturers and markets" }, "status": { "zh": "本档案未逐项建立", "en": "Not individually established in this dossier" }, "detail": { "zh": "不得由该美国品牌记录推定中国大陆、欧盟、日本或其他市场的批准、供应、价格、真伪或可替代性。", "en": "This U.S. brand record cannot establish approval, supply, price, authenticity or substitutability in Mainland China, the EU, Japan or another market." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "FLOMAX 是降压药吗？", "en": "Is FLOMAX a blood-pressure medicine?" }, "answer": { "zh": "不是。美国品牌标签明确它不用于治疗高血压。它仍可能引起体位性低血压、头晕或晕厥，所以完整药单和跌倒风险需要专业核对。", "en": "No. The U.S. brand label explicitly states it is not indicated for hypertension. It can still cause orthostatic hypotension, dizziness or syncope, so the full medicine list and fall risk need professional review." } }, { "question": { "zh": "0.4 mg 胶囊可以打开或压碎吗？", "en": "Can the 0.4 mg capsule be opened or crushed?" }, "answer": { "zh": "标签明确胶囊不得压碎、咀嚼或打开。吞咽困难或剂型疑问应联系开方医生或药师，不自行处理胶囊。", "en": "The label explicitly says the capsule must not be crushed, chewed or opened. Ask the prescriber or pharmacist about swallowing or dosage-form concerns rather than altering the capsule." } }, { "question": { "zh": "停了几天能按原来方式恢复吗？", "en": "Can it be restarted the same way after several missed days?" }, "answer": { "zh": "网页不提供恢复方案。标签有专门的中断后恢复段落，而低血压、晕厥、合并用药和个人情况会影响判断；应联系开方团队。", "en": "This page does not provide a restart plan. The label has a specific restart paragraph, and hypotension, syncope, co-medications and individual factors affect the decision; contact the prescribing team." } }, { "question": { "zh": "品牌营销记录结束是否等于坦索罗辛买不到？", "en": "Does the ended brand marketing record mean tamsulosin is unavailable?" }, "answer": { "zh": "不能这样推断。该日期只约束所示美国品牌 NDC；它既不证明全球停售，也不代表其他厂家、市场或渠道的实时库存。", "en": "No. The date applies only to the displayed U.S. brand NDC; it proves neither global discontinuation nor live stock for other manufacturers, markets or channels." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "dose-unit-literacy", "same-class-is-not-same-medicine", "interactions-are-not-a-home-scheduling-problem" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/flomax/", "en": "https://origindrug.com/en/drugs/flomax/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "minipress-prazosin", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-09-04", "status": "published_traceable_archive" }, "names": { "brand": "MINIPRESS", "generic": "盐酸哌唑嗪胶囊", "aliases": [ "Minipress", "prazosin", "prazosin hydrochloride", "prazosin capsules", "哌唑嗪", "盐酸哌唑嗪", "盐酸哌唑嗪胶囊", "MINIPRESS", "NDA 017442", "66993-431-85", "66993-432-85", "66993-433-85", "Pfizer 431 Minipress", "Pfizer 437 Minipress", "Pfizer 438 Minipress" ], "marketBrandNames": [ { "name": "MINIPRESS", "market": { "zh": "美国历史品牌档案", "en": "U.S. historical brand archive" }, "evidenceStatus": "historical_brand_pack_marketing_ended", "note": { "zh": "NDA 017442；品牌标签列 1、2、5 mg，各 250 粒瓶装；所示 NDC 在 2024 年结束营销。", "en": "NDA 017442; the brand label lists 1, 2 and 5 mg in 250-capsule bottles; the displayed NDC marketing records ended in 2024." }, "source": { "id": "src_294971ca52388f2e", "label": "DailyMed（NLM）：Pfizer MINIPRESS 1／2／5 mg 胶囊品牌标签档案（所列瓶装 NDC 已于 2024 年结束营销）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=36c4da56-502e-4da1-acf7-8e81ee453dcc", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_historical_document", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" } } ], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "心血管", "sourceArchiveMarket": "美国 DailyMed 的 Pfizer MINIPRESS 品牌标签列出 1、2、5 mg、各 250 粒瓶装，但三个所示品牌 NDC 的营销记录均已在 2024 年结束。Prasco 当前授权仿制药标签另列同一 NDA 017442 下 1、2、5 mg、各 90 粒瓶装，三项均无营销终止日期。品牌历史身份、授权仿制药、包装面板、胶囊印记、实时库存与个人适用性必须分开理解。", "dosageFormClass": "哌唑嗪盐酸盐普通口服胶囊；1、2、5 mg 是每粒以哌唑嗪计的含量，90 或 250 是对应瓶内粒数。当前授权仿制药胶囊仍带 Pfizer／Minipress 印记，但 Prasco 瓶标不是当前 MINIPRESS 品牌瓶装；印记、品牌和包装不能只看一个字段下结论。", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "1976-06-23（美国 NDA 017442 批准日期）", "archiveSponsorText": "Pfizer（MINIPRESS NDA 与历史品牌）；Prasco Laboratories（当前美国授权仿制药标签）" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [ "MINIPRESS", "MINIPRESS prazosin", "prazosin hydrochloride capsules", "盐酸哌唑嗪胶囊" ], "excludedProductCues": [ "HYTRIN", "terazosin", "RAPAFLO", "silodosin", "UROXATRAL", "alfuzosin", "CARDURA", "doxazosin", "FLOMAX", "tamsulosin", "CATAPRES", "clonidine" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-prasco-authorized-generic-prazosin-1mg-90-capsule-bottle-ndc-6699343185", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国授权仿制药标签（2026-03-06 更新；2026-03-09 发布）", "en": "Current U.S. authorised-generic DailyMed label (updated 6 Mar 2026; published 9 Mar 2026)" }, "dosageForm": { "zh": "Prasco 哌唑嗪盐酸盐普通口服硬胶囊（NDA 授权仿制药）", "en": "Prasco prazosin hydrochloride immediate-release oral hard capsule (NDA authorised generic)" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 66993-431-85", "pouchCode": null, "applicationNumber": "NDA 017442", "presentationRole": null, "primaryStrengthBasisCode": "per_capsule", "primaryDisplay": { "zh": "每粒以哌唑嗪计 1 mg；90 粒瓶装；当前授权仿制药", "en": "Prazosin 1 mg per capsule; 90-capsule bottle; current authorised generic" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=prazosin-02.jpg&setid=cbe89216-7dea-43d7-b12e-44ccfb69af3d&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "哌唑嗪（以盐酸盐形式）", "en": "prazosin (as hydrochloride)" }, "value": 1, "unit": "mg", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒标签标示量；不是个人粒数、使用频率、起始量或同类药换算值", "en": "labelled amount per capsule; not an individual's capsule count, frequency, starting amount or alpha-blocker conversion" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 90, "countUnit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-04", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "current_authorized_generic_regulatory_listing_not_live_stock", "marketingStartDate": "2021-08-25", "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 90, "unit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "physicalClues": { "color": { "zh": "白色", "en": "white" }, "shape": { "zh": "无刻痕硬胶囊，18 mm", "en": "unscored hard capsule, 18 mm" }, "imprint": { "zh": "Pfizer; 431; Minipress", "en": "Pfizer; 431; Minipress" }, "scoreStatus": "not_scored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_2a16eecb9b0e937f", "label": "DailyMed（NLM）：Prasco 哌唑嗪盐酸盐 1／2／5 mg 胶囊当前美国授权仿制药标签（SPL v6，2026-03-09 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=cbe89216-7dea-43d7-b12e-44ccfb69af3d", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-prasco-authorized-generic-prazosin-2mg-90-capsule-bottle-ndc-6699343285", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国授权仿制药标签（2026-03-06 更新；2026-03-09 发布）", "en": "Current U.S. authorised-generic DailyMed label (updated 6 Mar 2026; published 9 Mar 2026)" }, "dosageForm": { "zh": "Prasco 哌唑嗪盐酸盐普通口服硬胶囊（NDA 授权仿制药）", "en": "Prasco prazosin hydrochloride immediate-release oral hard capsule (NDA authorised generic)" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 66993-432-85", "pouchCode": null, "applicationNumber": "NDA 017442", "presentationRole": null, "primaryStrengthBasisCode": "per_capsule", "primaryDisplay": { "zh": "每粒以哌唑嗪计 2 mg；90 粒瓶装；当前授权仿制药", "en": "Prazosin 2 mg per capsule; 90-capsule bottle; current authorised generic" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=prazosin-03.jpg&setid=cbe89216-7dea-43d7-b12e-44ccfb69af3d&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "哌唑嗪（以盐酸盐形式）", "en": "prazosin (as hydrochloride)" }, "value": 2, "unit": "mg", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒标签标示量；不是个人粒数、使用频率、起始量或同类药换算值", "en": "labelled amount per capsule; not an individual's capsule count, frequency, starting amount or alpha-blocker conversion" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 90, "countUnit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-04", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "current_authorized_generic_regulatory_listing_not_live_stock", "marketingStartDate": "2022-03-11", "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 90, "unit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "physicalClues": { "color": { "zh": "粉红色与白色", "en": "pink and white" }, "shape": { "zh": "无刻痕硬胶囊，18 mm", "en": "unscored hard capsule, 18 mm" }, "imprint": { "zh": "Pfizer; 437; Minipress", "en": "Pfizer; 437; Minipress" }, "scoreStatus": "not_scored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_2a16eecb9b0e937f", "label": "DailyMed（NLM）：Prasco 哌唑嗪盐酸盐 1／2／5 mg 胶囊当前美国授权仿制药标签（SPL v6，2026-03-09 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=cbe89216-7dea-43d7-b12e-44ccfb69af3d", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-prasco-authorized-generic-prazosin-5mg-90-capsule-bottle-ndc-6699343385", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国授权仿制药标签（2026-03-06 更新；2026-03-09 发布）", "en": "Current U.S. authorised-generic DailyMed label (updated 6 Mar 2026; published 9 Mar 2026)" }, "dosageForm": { "zh": "Prasco 哌唑嗪盐酸盐普通口服硬胶囊（NDA 授权仿制药）", "en": "Prasco prazosin hydrochloride immediate-release oral hard capsule (NDA authorised generic)" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 66993-433-85", "pouchCode": null, "applicationNumber": "NDA 017442", "presentationRole": null, "primaryStrengthBasisCode": "per_capsule", "primaryDisplay": { "zh": "每粒以哌唑嗪计 5 mg；90 粒瓶装；当前授权仿制药", "en": "Prazosin 5 mg per capsule; 90-capsule bottle; current authorised generic" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=prazosin-04.jpg&setid=cbe89216-7dea-43d7-b12e-44ccfb69af3d&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "哌唑嗪（以盐酸盐形式）", "en": "prazosin (as hydrochloride)" }, "value": 5, "unit": "mg", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒标签标示量；不是个人粒数、使用频率、起始量或同类药换算值", "en": "labelled amount per capsule; not an individual's capsule count, frequency, starting amount or alpha-blocker conversion" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 90, "countUnit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-04", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "current_authorized_generic_regulatory_listing_not_live_stock", "marketingStartDate": "2022-03-11", "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 90, "unit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "physicalClues": { "color": { "zh": "蓝色与白色", "en": "blue and white" }, "shape": { "zh": "无刻痕硬胶囊，22 mm", "en": "unscored hard capsule, 22 mm" }, "imprint": { "zh": "Pfizer; 438; Minipress", "en": "Pfizer; 438; Minipress" }, "scoreStatus": "not_scored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_2a16eecb9b0e937f", "label": "DailyMed（NLM）：Prasco 哌唑嗪盐酸盐 1／2／5 mg 胶囊当前美国授权仿制药标签（SPL v6，2026-03-09 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=cbe89216-7dea-43d7-b12e-44ccfb69af3d", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-prasco-authorized-generic-prazosin-1mg-90-capsule-bottle-ndc-6699343185", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=prazosin-02.jpg&setid=cbe89216-7dea-43d7-b12e-44ccfb69af3d&type=img", "alt": "Prasco 哌唑嗪盐酸盐 1 mg、NDC 66993-431-85、90 粒瓶装当前美国授权仿制药 DailyMed 官方标签面板", "archiveMarket": "美国", "labelVersion": "DailyMed 当前美国授权仿制药标签（2026-03-06 更新；2026-03-09 发布）", "presentation": "当前授权仿制药准确包装：1 mg 白色胶囊，印有 Pfizer／431／Minipress；NDC 66993-431-85，90 粒瓶装。2 mg 与 5 mg 有各自颜色、印记和 NDC。", "notice": "图片只对应 Prasco 当前授权仿制药瓶标。胶囊上的 Pfizer／Minipress 印记不能把它变成当前品牌瓶装；图像不用于鉴定真伪，也不能证明实时库存或其他市场供应。", "source": { "id": "src_2a16eecb9b0e937f", "label": "DailyMed（NLM）：Prasco 哌唑嗪盐酸盐 1／2／5 mg 胶囊当前美国授权仿制药标签（SPL v6，2026-03-09 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=cbe89216-7dea-43d7-b12e-44ccfb69af3d", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "哌唑嗪说明书放大阅读：每粒 mg、瓶内粒数、首次使用、晕厥与同类重复", "en": "Enlarged prazosin label: per-capsule mg, bottle count, starting risk, syncope and duplicate alpha blockers" }, "summary": { "zh": "1、2、5 mg 是每粒哌唑嗪量，90 是当前授权仿制药瓶内粒数，250 是历史品牌瓶装数量。标签重点警示首次使用、快速增加或加入其他降压药时的体位性低血压和晕厥；网页不把剂量段落转成个人方案。", "en": "The 1, 2 and 5 mg figures are amounts of prazosin per capsule; 90 is the current authorised-generic bottle count and 250 is the historical brand bottle count. The label prominently warns about postural hypotension and syncope when starting, increasing rapidly or adding another antihypertensive; the site does not turn dosing text into an individual plan." }, "checks": [ { "zh": "老人、独居者、有跌倒史、夜间起身或同时使用其他降压药者，应把准确药盒、血压、头晕或晕厥情况和完整药单交给医生或药师核对，不能根据网页自己从 1 mg 换到 2 mg 或 5 mg。", "en": "Older adults, people living alone, those with falls or night-time rising, and people using another antihypertensive should have the exact pack, blood pressure, dizziness or syncope and full medicine list reviewed; do not use the page to move from 1 mg to 2 mg or 5 mg." }, { "zh": "标签说明同时加入利尿剂、β 阻滞剂或其他降压药可能增加低血压影响。错开服用时间不等于风险消失，网页也不能代替开方团队调整。", "en": "The label explains that adding a diuretic, beta blocker or another antihypertensive may increase hypotensive effects. Self-spacing does not prove that risk has disappeared and cannot replace prescriber review." }, { "zh": "同类 α 阻滞剂以及 PDE-5 抑制剂可能共同影响血压。MINIPRESS、HYTRIN、CARDURA、FLOMAX、RAPAFLO、UROXATRAL、CIALIS 或 VIAGRA 出现在同一药单时，要核对而不是自行轮换或叠加。", "en": "Related alpha blockers and PDE-5 inhibitors may have combined blood-pressure effects. If MINIPRESS, HYTRIN, CARDURA, FLOMAX, RAPAFLO, UROXATRAL, CIALIS or VIAGRA appear on one list, seek review rather than self-alternating or combining them." }, { "zh": "晕厥、跌倒受伤或严重虚弱需要及时医疗评估；持续超过 4 小时的勃起是 FDA 标签明确的急症信号，应立即使用当地急救渠道。", "en": "Syncope, an injurious fall or severe weakness needs timely medical assessment. An erection lasting more than four hours is an FDA-labelled emergency signal requiring immediate local emergency care." } ], "source": { "id": "src_2a16eecb9b0e937f", "label": "DailyMed（NLM）：Prasco 哌唑嗪盐酸盐 1／2／5 mg 胶囊当前美国授权仿制药标签（SPL v6，2026-03-09 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=cbe89216-7dea-43d7-b12e-44ccfb69af3d", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "哌唑嗪怎样起作用：阻断 α1 受体可降低血管阻力，也带来起立性低血压边界", "en": "How prazosin works: alpha-1 blockade can lower vascular resistance and creates an orthostatic-hypotension boundary" }, "summary": { "zh": "官方标签将哌唑嗪描述为 α1 肾上腺素能受体阻断剂，其血压作用与降低外周血管阻力有关。机理能解释为什么同用其他降压药时需谨慎，但不能决定某个人该用哪一粒、何时开始或能否改成另一种 α 阻滞剂。", "en": "The official label describes prazosin as an alpha-1 adrenergic blocker whose blood-pressure effect is associated with reduced peripheral vascular resistance. Mechanism helps explain caution with other blood-pressure medicines but cannot select an individual's capsule, starting time or switch to another alpha blocker." }, "checks": [ { "zh": "MINIPRESS、HYTRIN、CARDURA、FLOMAX、RAPAFLO 和 UROXATRAL 是不同成分或产品。共同的 α 阻滞机制不建立 mg 换算、同服、轮换或替换规则。", "en": "MINIPRESS, HYTRIN, CARDURA, FLOMAX, RAPAFLO and UROXATRAL are different ingredients or products. Related alpha blockade creates no milligram conversion, combination, alternation or substitution rule." }, { "zh": "当前 Prasco 授权仿制药与历史 Pfizer 品牌瓶装同属 NDA 017442，但瓶标、包装数量和市场时间不同；相同申请号不表示包装完全相同或实时有货。", "en": "The current Prasco authorised generic and historical Pfizer brand bottles share NDA 017442, but their labels, counts and market dates differ. A shared application number does not make the packs identical or establish live stock." }, { "zh": "作用机理不能替代血压、跌倒史、肝肾情况、完整药单和专业评估，也不能依据一次头晕或夜尿自行判断继续、停用或换药。", "en": "Mechanism does not replace blood pressure, fall history, liver/kidney status, the full medicine list and professional assessment, or decide continuation, stopping or switching from one episode of dizziness or nocturia." } ], "source": { "id": "src_2a16eecb9b0e937f", "label": "DailyMed（NLM）：Prasco 哌唑嗪盐酸盐 1／2／5 mg 胶囊当前美国授权仿制药标签（SPL v6，2026-03-09 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=cbe89216-7dea-43d7-b12e-44ccfb69af3d", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "MINIPRESS", "generic": "盐酸哌唑嗪胶囊", "dosageFormClass": "哌唑嗪盐酸盐普通口服胶囊；1、2、5 mg 是每粒以哌唑嗪计的含量，90 或 250 是对应瓶内粒数。当前授权仿制药胶囊仍带 Pfizer／Minipress 印记，但 Prasco 瓶标不是当前 MINIPRESS 品牌瓶装；印记、品牌和包装不能只看一个字段下结论。" }, "labelSource": { "id": "src_2a16eecb9b0e937f", "label": "DailyMed（NLM）：Prasco 哌唑嗪盐酸盐 1／2／5 mg 胶囊当前美国授权仿制药标签（SPL v6，2026-03-09 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=cbe89216-7dea-43d7-b12e-44ccfb69af3d", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" }, "productRoutes": [ { "source": { "id": "src_2a16eecb9b0e937f", "label": "DailyMed（NLM）：Prasco 哌唑嗪盐酸盐 1／2／5 mg 胶囊当前美国授权仿制药标签（SPL v6，2026-03-09 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=cbe89216-7dea-43d7-b12e-44ccfb69af3d", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-09-04", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_725211c55a3e8271", "label": "DailyMed（NLM）：Prasco 哌唑嗪盐酸盐当前美国授权仿制药电子说明书 PDF", "url": "https://dailymed.nlm.nih.gov/dailymed/downloadpdffile.cfm?setId=cbe89216-7dea-43d7-b12e-44ccfb69af3d", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-09-04", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_294971ca52388f2e", "label": "DailyMed（NLM）：Pfizer MINIPRESS 1／2／5 mg 胶囊品牌标签档案（所列瓶装 NDC 已于 2024 年结束营销）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=36c4da56-502e-4da1-acf7-8e81ee453dcc", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_historical_document", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-09-04", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-09-04", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "MINIPRESS 是哌唑嗪的美国品牌历史档案。普通人最容易误读的是：1、2、5 mg 是每粒含量，90 或 250 是一瓶的粒数；当前 Prasco 授权仿制药胶囊虽保留 Pfizer／Minipress 印记，瓶标却是通用名产品。老人、多药使用者和有头晕、起立不稳或跌倒史的人，应重点核对突然降压、晕厥、其他降压药与 PDE-5 抑制剂；网页不提供个人起始、恢复、加量、停药或换药方案。", "history": "FDA 资料显示 MINIPRESS 胶囊 NDA 017442 于 1976-06-23 批准。2015 年补充批准加入持续勃起相关紧急警示。DailyMed 保留 Pfizer 品牌标签，但三个 250 粒品牌瓶装记录在 2024 年结束营销；当前 Prasco 授权仿制药则分别建立三个 90 粒瓶装身份。", "sourceDocuments": [ { "id": "src_2a16eecb9b0e937f", "label": "DailyMed（NLM）：Prasco 哌唑嗪盐酸盐 1／2／5 mg 胶囊当前美国授权仿制药标签（SPL v6，2026-03-09 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=cbe89216-7dea-43d7-b12e-44ccfb69af3d", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" }, { "id": "src_725211c55a3e8271", "label": "DailyMed（NLM）：Prasco 哌唑嗪盐酸盐当前美国授权仿制药电子说明书 PDF", "url": "https://dailymed.nlm.nih.gov/dailymed/downloadpdffile.cfm?setId=cbe89216-7dea-43d7-b12e-44ccfb69af3d", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" }, { "id": "src_294971ca52388f2e", "label": "DailyMed（NLM）：Pfizer MINIPRESS 1／2／5 mg 胶囊品牌标签档案（所列瓶装 NDC 已于 2024 年结束营销）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=36c4da56-502e-4da1-acf7-8e81ee453dcc", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_historical_document", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" }, { "id": "src_af227bae6b44bd12", "label": "FDA：MINIPRESS 哌唑嗪盐酸盐 1／2／5 mg 胶囊补充批准函（2015-02-27）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/017442Orig1s043ltr.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_regulatory_document", "documentKind": "regulatory_approval_letter", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" } ], "applicationNumber": "NDA 017442", "approvalTimeline": [ { "date": "1976-06-23", "title": { "zh": "MINIPRESS 胶囊 NDA 获 FDA 批准", "en": "FDA approval of the MINIPRESS capsule NDA" }, "detail": { "zh": "NDA 017442；1、2、5 mg 产品历史均早于 1982 年。", "en": "NDA 017442; the 1, 2 and 5 mg product histories all predate 1982." }, "source": { "id": "src_af227bae6b44bd12", "label": "FDA：MINIPRESS 哌唑嗪盐酸盐 1／2／5 mg 胶囊补充批准函（2015-02-27）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/017442Orig1s043ltr.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_regulatory_document", "documentKind": "regulatory_approval_letter", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" } }, { "date": "2015-02-27", "title": { "zh": "FDA 批准持续勃起警示更新", "en": "FDA approved the priapism warning update" }, "detail": { "zh": "补充批准函覆盖 1、2、5 mg 胶囊并加入超过 4 小时需立即求助的急症文字。", "en": "The supplement covered the 1, 2 and 5 mg capsules and added emergency wording for an erection lasting over four hours." }, "source": { "id": "src_af227bae6b44bd12", "label": "FDA：MINIPRESS 哌唑嗪盐酸盐 1／2／5 mg 胶囊补充批准函（2015-02-27）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/017442Orig1s043ltr.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_regulatory_document", "documentKind": "regulatory_approval_letter", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" } }, { "date": "2026-03-09", "title": { "zh": "当前 Prasco 授权仿制药 SPL v6 发布", "en": "Current Prasco authorised-generic SPL v6 published" }, "detail": { "zh": "三个 90 粒瓶装均在册且无营销终止日期。", "en": "All three 90-capsule bottles are listed without a marketing-end date." }, "source": { "id": "src_2a16eecb9b0e937f", "label": "DailyMed（NLM）：Prasco 哌唑嗪盐酸盐 1／2／5 mg 胶囊当前美国授权仿制药标签（SPL v6，2026-03-09 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=cbe89216-7dea-43d7-b12e-44ccfb69af3d", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" } } ], "marketStatus": [ { "market": { "zh": "美国 MINIPRESS 品牌包装", "en": "U.S. MINIPRESS brand packs" }, "status": { "zh": "三个所示品牌瓶装 NDC 已结束营销", "en": "The three displayed brand-bottle NDC marketing records have ended" }, "detail": { "zh": "1、2、5 mg，各 250 粒；结束日期分别为 2024-04-30、2024-05-31、2024-05-31。", "en": "1, 2 and 5 mg, each in 250-capsule bottles; end dates were 30 Apr 2024, 31 May 2024 and 31 May 2024." } }, { "market": { "zh": "美国 Prasco 授权仿制药", "en": "U.S. Prasco authorised generic" }, "status": { "zh": "当前公开标签在册", "en": "Current public-label listing" }, "detail": { "zh": "1、2、5 mg，各 90 粒瓶装；不等于实时库存或当前品牌瓶装。", "en": "1, 2 and 5 mg in 90-capsule bottles; this does not establish live stock or a current brand bottle." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "为什么通用名瓶子里的胶囊还写着 Minipress？", "en": "Why does a generic-name bottle contain capsules marked Minipress?" }, "answer": { "zh": "当前官方记录把 Prasco 产品标为 NDA 授权仿制药，并列出胶囊上的 Pfizer／431、437 或 438／Minipress 印记。应同时读瓶标主体、NDC、强度、粒数和标签日期，不能只凭胶囊一个词判断品牌或真伪。", "en": "The current official record classifies the Prasco products as NDA authorised generics and lists Pfizer/431, 437 or 438/Minipress capsule imprints. Read the bottle entity, NDC, strength, count and label date together; one word on a capsule cannot determine brand status or authenticity." } }, { "question": { "zh": "1 mg、2 mg、5 mg 能按倍数自行换吗？", "en": "Can 1 mg, 2 mg and 5 mg be swapped by arithmetic?" }, "answer": { "zh": "不能。数字表示每粒含量，不是自行拼粒、减量、起始、恢复或轮换方案。哌唑嗪有明显的首次使用与体位性低血压风险，必须让开方团队结合血压、症状和完整药单判断。", "en": "No. The figures are amounts per capsule, not a self-designed capsule combination, reduction, start, restart or rotation plan. Prazosin has important starting and postural-hypotension risks requiring prescriber review with blood pressure, symptoms and the full medicine list." } }, { "question": { "zh": "能和 HYTRIN、FLOMAX 或降压药一起吃吗？", "en": "Can it be taken with HYTRIN, FLOMAX or another blood-pressure medicine?" }, "answer": { "zh": "网页不能作出这个决定。相同或相关作用可能增加降压、头晕、晕厥和跌倒风险；把每个实际包装、使用时间和完整药单交给医生或药师核对，不要自行错开、叠加或换用。", "en": "A website cannot make that decision. Related effects may increase hypotension, dizziness, syncope and falls; give the exact packs, timing and full medicine list to a clinician or pharmacist rather than self-spacing, combining or switching." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "dose-unit-literacy", "same-class-is-not-same-medicine", "interactions-are-not-a-home-scheduling-problem" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/minipress-prazosin/", "en": "https://origindrug.com/en/drugs/minipress-prazosin/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "clarinex-desloratadine", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-09-03", "status": "published_traceable_archive" }, "names": { "brand": "CLARINEX", "generic": "地氯雷他定片", "aliases": [ "Clarinex", "desloratadine", "desloratadine tablets", "地氯雷他定", "地氯雷他定片", "CLARINEX", "NDA 021165", "78206-119-01", "78206-188-01", "C5", "SP" ], "marketBrandNames": [ { "name": "CLARINEX", "market": { "zh": "美国处方品牌", "en": "U.S. prescription brand" }, "evidenceStatus": "current_regulatory_record", "note": { "zh": "NDA 021165；当前公开包装为 5 mg 普通片、100 片瓶装。", "en": "NDA 021165; current public packs are 5 mg immediate-release tablets in 100-tablet bottles." }, "source": { "id": "src_b01f54336fd75a97", "label": "DailyMed（NLM）：CLARINEX 地氯雷他定 5 mg 薄膜衣片当前美国处方标签（SPL v6，2025-05-28 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c671342e-69a2-4ca5-abc2-8166ed4240d4", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-03", "reviewedAt": "2026-09-03" } } ], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "呼吸系统", "sourceArchiveMarket": "当前 DailyMed 标签显示美国 CLARINEX 5 mg 普通薄膜衣片，两个 NDC 均为 100 片瓶装；同一标签明确说明 CLARINEX 品牌口服液和 RediTabs 口崩片已不再销售。其他厂家地氯雷他定、CLARINEX-D 复方缓释片以及其他国家的批准、供应和法律分类必须另查当地记录。", "dosageFormClass": "普通薄膜衣口服片。5 mg 表示每片含有的地氯雷他定量，100 表示每瓶片数；两个数字不能相乘或直接变成个人每天吃几片。口服液浓度、口崩片和含伪麻黄碱的 CLARINEX-D 是不同产品身份，不能混算。", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "2001（美国 NDA 021165 首次批准）", "archiveSponsorText": "Schering-Plough/Merck（研发与批准历史）；Organon LLC（当前美国公开标签）" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [ "CLARINEX desloratadine", "CLARINEX 地氯雷他定片" ], "excludedProductCues": [ "CLARINEX-D", "CLARINEX-D 12 HOUR", "desloratadine pseudoephedrine", "CLARITIN", "loratadine", "氯雷他定", "XYZAL", "levocetirizine", "ZYRTEC", "cetirizine" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-clarinex-desloratadine-tablet-5mg-100-bottle-ndc-78206-119-01", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国处方品牌标签（SPL v6，2025-05-28 发布）", "en": "Current U.S. prescription brand label (SPL v6, published 28 May 2025)" }, "dosageForm": { "zh": "CLARINEX 地氯雷他定普通薄膜衣片", "en": "CLARINEX desloratadine immediate-release film-coated tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 78206-119-01", "pouchCode": null, "applicationNumber": "NDA 021165", "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片地氯雷他定 5 mg；100 片高密度聚乙烯瓶装", "en": "Desloratadine 5 mg per tablet; 100-tablet high-density polyethylene bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=clarinex-02.jpg&setid=c671342e-69a2-4ca5-abc2-8166ed4240d4&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "地氯雷他定", "en": "desloratadine" }, "value": 5, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是任何人的片数、频率或疗程", "en": "labelled amount per tablet; not an individual's tablet count, frequency or course" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "高密度聚乙烯瓶", "en": "high-density polyethylene bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-03", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "current_regulatory_listing_not_live_stock", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "浅蓝色", "en": "light blue" }, "shape": { "zh": "圆形薄膜衣片，无刻痕", "en": "round film-coated tablet, not scored" }, "imprint": { "zh": "C5", "en": "C5" }, "scoreStatus": "not_scored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_b01f54336fd75a97", "label": "DailyMed（NLM）：CLARINEX 地氯雷他定 5 mg 薄膜衣片当前美国处方标签（SPL v6，2025-05-28 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c671342e-69a2-4ca5-abc2-8166ed4240d4", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-03", "reviewedAt": "2026-09-03" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-clarinex-desloratadine-tablet-5mg-100-bottle-ndc-78206-188-01", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国处方品牌标签（SPL v6，2025-05-28 发布）", "en": "Current U.S. prescription brand label (SPL v6, published 28 May 2025)" }, "dosageForm": { "zh": "CLARINEX 地氯雷他定普通薄膜衣片", "en": "CLARINEX desloratadine immediate-release film-coated tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 78206-188-01", "pouchCode": null, "applicationNumber": "NDA 021165", "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片地氯雷他定 5 mg；100 片高密度聚乙烯瓶装", "en": "Desloratadine 5 mg per tablet; 100-tablet high-density polyethylene bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=clarinex-03.jpg&setid=c671342e-69a2-4ca5-abc2-8166ed4240d4&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "地氯雷他定", "en": "desloratadine" }, "value": 5, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是任何人的片数、频率或疗程", "en": "labelled amount per tablet; not an individual's tablet count, frequency or course" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "高密度聚乙烯瓶", "en": "high-density polyethylene bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-03", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "current_regulatory_listing_not_live_stock", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "浅蓝色", "en": "light blue" }, "shape": { "zh": "圆形薄膜衣片，无刻痕", "en": "round film-coated tablet, not scored" }, "imprint": { "zh": "SP", "en": "SP" }, "scoreStatus": "not_scored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_b01f54336fd75a97", "label": "DailyMed（NLM）：CLARINEX 地氯雷他定 5 mg 薄膜衣片当前美国处方标签（SPL v6，2025-05-28 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c671342e-69a2-4ca5-abc2-8166ed4240d4", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-03", "reviewedAt": "2026-09-03" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-clarinex-desloratadine-tablet-5mg-100-bottle-ndc-78206-119-01", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=clarinex-02.jpg&setid=c671342e-69a2-4ca5-abc2-8166ed4240d4&type=img", "alt": "美国 CLARINEX 地氯雷他定 5 mg、NDC 78206-119-01、100 片瓶装 DailyMed 官方标签面板", "archiveMarket": "美国", "labelVersion": "DailyMed 当前美国处方品牌标签（SPL v6，2025-05-28 发布）", "presentation": "CLARINEX 5 mg：每片 5 mg，浅蓝色圆形无刻痕片，印有 C5；NDC 78206-119-01，100 片瓶装。", "notice": "此图只对应这一美国品牌包装。另一个当前 NDC 的片面印记为 SP；图像不用于鉴定真伪，也不能证明实时库存、其他厂家或市场，更不能生成个人用药方案。", "source": { "id": "src_b01f54336fd75a97", "label": "DailyMed（NLM）：CLARINEX 地氯雷他定 5 mg 薄膜衣片当前美国处方标签（SPL v6，2025-05-28 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c671342e-69a2-4ca5-abc2-8166ed4240d4", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-03", "reviewedAt": "2026-09-03" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "CLARINEX 说明书放大阅读：5 mg、100 片、嗜睡、肝肾功能与重复抗组胺药", "en": "CLARINEX enlarged label: 5 mg, 100 tablets, sleepiness, liver/kidney function and duplicate antihistamines" }, "summary": { "zh": "5 mg 是一片中的药量，100 片是瓶内数量，不是个人每天片数。当前美国品牌标签只展示普通片；品牌口服液和口崩片虽保留在临床文字中，但已不再销售。网页帮助读懂准确产品和风险问题，不计算个人频率、疗程、减量或换药。", "en": "Five mg is the amount in one tablet and 100 is the number of tablets in the bottle, not an individual's daily count. The current U.S. brand label displays only immediate-release tablets; the brand oral solution and orally disintegrating tablets remain in clinical text but are no longer marketed. The site explains exact-product and safety questions without calculating individual frequency, course, taper or switching." }, "checks": [ { "zh": "两个当前瓶装产品都是每片 5 mg、每瓶 100 片，但 NDC 与药片印记不同：78206-119-01 对应 C5，78206-188-01 对应 SP。名称或颜色相近不能代替 NDC、剂型、强度、包装和标签日期的完整核对。", "en": "Both current bottles contain 5 mg per tablet and 100 tablets, but their NDCs and imprints differ: 78206-119-01 is C5 and 78206-188-01 is SP. A similar name or colour cannot replace a complete check of NDC, dosage form, strength, pack and label date." }, { "zh": "标签写明肝功能或肾功能受损成人需要不同的起始安排。网页不把该文字转换为个人隔日、减半或停药指令；老人或有肝肾问题者应让医生或药师结合实际产品、检验和完整药单判断。", "en": "The label states that adults with hepatic or renal impairment need a different starting arrangement. This page does not convert that text into an individual alternate-day, half-tablet or stopping instruction; older adults and people with liver or kidney problems need the exact product, clinical information and complete medicine list reviewed by a clinician or pharmacist." }, { "zh": "标签列有疲劳、嗜睡、眩晕等信息，也要求告知医生所有处方药、非处方药、维生素和草药。老人和多药使用者应特别核对跌倒、驾驶和重复抗组胺药风险，不要靠自行错开时间假定叠加风险消失。", "en": "The label includes fatigue, sleepiness and dizziness and asks patients to disclose prescription medicines, nonprescription medicines, vitamins and herbs. Older adults and people using multiple medicines should review falls, driving and duplicate-antihistamine risks rather than assume self-spacing removes combined effects." }, { "zh": "皮疹、荨麻疹、面唇舌喉肿胀、呼吸困难可能是严重过敏反应线索。呼吸困难或面舌喉肿胀应立即使用当地急救渠道；网页搜索不能代替急救。", "en": "Rash, hives, swelling of the face, lips, tongue or throat, and breathing difficulty can signal a serious hypersensitivity reaction. Breathing difficulty or facial, tongue or throat swelling requires local emergency help; website search cannot replace emergency care." } ], "source": { "id": "src_b01f54336fd75a97", "label": "DailyMed（NLM）：CLARINEX 地氯雷他定 5 mg 薄膜衣片当前美国处方标签（SPL v6，2025-05-28 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c671342e-69a2-4ca5-abc2-8166ed4240d4", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-03", "reviewedAt": "2026-09-03" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "地氯雷他定怎样起作用：外周 H1 受体拮抗不等于所有抗组胺药可互换", "en": "How desloratadine works: peripheral H1 antagonism does not make antihistamines interchangeable" }, "summary": { "zh": "标签将地氯雷他定描述为长效 H1 受体拮抗剂，并说明它是氯雷他定的主要活性代谢物。该机制帮助理解过敏症状通路，但不证明症状一定由过敏引起，也不建立与氯雷他定、西替利嗪、左西替利嗪、非索非那定或苯海拉明的 mg 换算、同服或轮换规则。", "en": "The label describes desloratadine as a long-acting H1-receptor antagonist and the major active metabolite of loratadine. This helps explain an allergy pathway but does not prove symptoms are allergic or create milligram conversion, combination or rotation rules with loratadine, cetirizine, levocetirizine, fexofenadine or diphenhydramine." }, "checks": [ { "zh": "CLARINEX 与 CLARITIN 名称和成分关系密切，但不是同一个准确产品；不能因为“是代谢物”就在家自行按 mg 换算、叠加或隔天轮换。", "en": "CLARINEX and CLARITIN are closely related in name and chemistry but are not the same exact product; being a metabolite does not support home milligram conversion, combination or alternate-day rotation." }, { "zh": "CLARINEX-D 12 HOUR 还含伪麻黄碱，并且是缓释复方片；它不是本页的单成分普通片。鼻塞患者尤其要核对完整成分，避免把复方产品当成普通 CLARINEX。", "en": "CLARINEX-D 12 HOUR also contains pseudoephedrine and is an extended-release combination tablet; it is not the single-ingredient immediate-release tablet in this dossier. People checking congestion products should compare the full ingredient list rather than treat the combination as ordinary CLARINEX." }, { "zh": "同属抗组胺药不代表疗效、副作用、肝肾处理或剂型相同。出现持续或不明原因症状，应由专业人员核对诊断和完整药单，而不是在同类药之间自行试换。", "en": "Belonging to the antihistamine class does not make efficacy, adverse effects, liver/kidney handling or dosage forms identical. Persistent or unexplained symptoms need professional review of the diagnosis and complete medicine list rather than self-switching within the class." } ], "source": { "id": "src_b01f54336fd75a97", "label": "DailyMed（NLM）：CLARINEX 地氯雷他定 5 mg 薄膜衣片当前美国处方标签（SPL v6，2025-05-28 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c671342e-69a2-4ca5-abc2-8166ed4240d4", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-03", "reviewedAt": "2026-09-03" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "CLARINEX", "generic": "地氯雷他定片", "dosageFormClass": "普通薄膜衣口服片。5 mg 表示每片含有的地氯雷他定量，100 表示每瓶片数；两个数字不能相乘或直接变成个人每天吃几片。口服液浓度、口崩片和含伪麻黄碱的 CLARINEX-D 是不同产品身份，不能混算。" }, "labelSource": { "id": "src_b01f54336fd75a97", "label": "DailyMed（NLM）：CLARINEX 地氯雷他定 5 mg 薄膜衣片当前美国处方标签（SPL v6，2025-05-28 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c671342e-69a2-4ca5-abc2-8166ed4240d4", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-03", "reviewedAt": "2026-09-03" }, "productRoutes": [ { "source": { "id": "src_b01f54336fd75a97", "label": "DailyMed（NLM）：CLARINEX 地氯雷他定 5 mg 薄膜衣片当前美国处方标签（SPL v6，2025-05-28 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c671342e-69a2-4ca5-abc2-8166ed4240d4", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-03", "reviewedAt": "2026-09-03" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-09-03", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-09-03", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "CLARINEX 是地氯雷他定品牌档案。普通人应先认清：5 mg 是每片含量，100 是一瓶的总片数；当前美国品牌公开记录只有普通片，品牌口服液与口崩片已不再销售。老人、多药使用者以及有肝肾问题、嗜睡、眩晕或跌倒风险的人，应带完整药单核对重复抗组胺药和镇静影响，不能依据网页自行增加频率、换药或与 Claritin/氯雷他定、XYZAL、ZYRTEC 等叠加。", "history": "FDA 资料显示 CLARINEX 地氯雷他定 5 mg 普通片于 2001 年获批；口崩片和口服液随后以各自 NDA 获批。2014 年 FDA 批准函记录多剂型标签更新；当前 DailyMed 标签保留多剂型临床信息，但明确品牌口服液和 RediTabs 已不再销售，并展示现行 5 mg 普通片包装。", "sourceDocuments": [ { "id": "src_b01f54336fd75a97", "label": "DailyMed（NLM）：CLARINEX 地氯雷他定 5 mg 薄膜衣片当前美国处方标签（SPL v6，2025-05-28 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c671342e-69a2-4ca5-abc2-8166ed4240d4", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-03", "reviewedAt": "2026-09-03" }, { "id": "src_041a6e68c6b7812c", "label": "FDA：CLARINEX 地氯雷他定片、口服液与 RediTabs 补充批准函（2014-05-06）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021165Orig1s017,021300Orig1s014,021312Orig1s015,021563Orig1s003ltr.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_regulatory_document", "documentKind": "regulatory_approval_letter", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-03", "reviewedAt": "2026-09-03" } ], "applicationNumber": "NDA 021165", "approvalTimeline": [ { "date": "2001-12-21", "title": { "zh": "CLARINEX 5 mg 普通片在美国获批", "en": "U.S. approval of CLARINEX 5 mg tablets" }, "detail": { "zh": "FDA 资料将 NDA 021165 与 5 mg 地氯雷他定普通片首次批准相连。", "en": "FDA materials link NDA 021165 to the initial approval of 5 mg desloratadine tablets." }, "source": { "id": "src_041a6e68c6b7812c", "label": "FDA：CLARINEX 地氯雷他定片、口服液与 RediTabs 补充批准函（2014-05-06）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021165Orig1s017,021300Orig1s014,021312Orig1s015,021563Orig1s003ltr.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_regulatory_document", "documentKind": "regulatory_approval_letter", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-03", "reviewedAt": "2026-09-03" } }, { "date": "2014-05-06", "title": { "zh": "FDA 批准多剂型标签更新", "en": "FDA approved multi-formulation labelling updates" }, "detail": { "zh": "补充批准函覆盖普通片、口服液与 RediTabs，并加入上市后运动障碍相关措辞。", "en": "The supplement approval covers tablets, oral solution and RediTabs and adds postmarketing movement-disorder wording." }, "source": { "id": "src_041a6e68c6b7812c", "label": "FDA：CLARINEX 地氯雷他定片、口服液与 RediTabs 补充批准函（2014-05-06）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021165Orig1s017,021300Orig1s014,021312Orig1s015,021563Orig1s003ltr.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_regulatory_document", "documentKind": "regulatory_approval_letter", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-03", "reviewedAt": "2026-09-03" } }, { "date": "2025-05-28", "title": { "zh": "当前 DailyMed SPL v6 发布", "en": "Current DailyMed SPL v6 published" }, "detail": { "zh": "当前记录展示两种 5 mg、100 片瓶装包装，并说明品牌口服液和口崩片已不再销售。", "en": "The current record displays two 5 mg, 100-tablet bottles and says the brand oral solution and orally disintegrating tablets are no longer marketed." }, "source": { "id": "src_b01f54336fd75a97", "label": "DailyMed（NLM）：CLARINEX 地氯雷他定 5 mg 薄膜衣片当前美国处方标签（SPL v6，2025-05-28 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c671342e-69a2-4ca5-abc2-8166ed4240d4", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-03", "reviewedAt": "2026-09-03" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "当前品牌处方片公开标签", "en": "Current public brand prescription-tablet label" }, "detail": { "zh": "NDA 021165；5 mg 普通片，两个 100 片瓶装 NDC。", "en": "NDA 021165; 5 mg immediate-release tablets in two 100-tablet bottle NDCs." } }, { "market": { "zh": "美国品牌其他剂型", "en": "Other U.S. brand dosage forms" }, "status": { "zh": "口服液与 RediTabs 已不再销售", "en": "Oral solution and RediTabs no longer marketed" }, "detail": { "zh": "临床文字仍可见，但不能据此声称当前品牌有货。", "en": "Clinical text remains visible but does not establish current brand availability." } }, { "market": { "zh": "美国以外", "en": "Outside the United States" }, "status": { "zh": "本档案未确认当地产品", "en": "Local products not established in this dossier" }, "detail": { "zh": "需回到当地监管记录和手中药盒。", "en": "Check the local regulator and the pack in hand." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "5 mg 和 100 片分别是什么意思？", "en": "What do 5 mg and 100 tablets mean?" }, "answer": { "zh": "5 mg 是每片地氯雷他定含量，100 片是这瓶中的片数。它们是产品身份字段，不等于任何人的每日片数、使用频率或疗程。", "en": "Five mg is the amount of desloratadine in each tablet; 100 tablets is the count in the bottle. These are product-identity fields, not an individual's daily count, frequency or course." } }, { "question": { "zh": "能和 Claritin、XYZAL、ZYRTEC 或感冒药一起吃吗？", "en": "Can it be taken with Claritin, XYZAL, ZYRTEC or a cold medicine?" }, "answer": { "zh": "网页不能作出这个决定。很多处方和 OTC 感冒／过敏产品会重复抗组胺成分或增加嗜睡；应把每个实际包装的完整成分表和药单交给药师或医生核对。", "en": "A website cannot make that decision. Many prescription and OTC cold/allergy products duplicate antihistamines or add sedation; give a pharmacist or clinician the full ingredient lists from every actual pack and the complete medicine list." } }, { "question": { "zh": "没有 C5 印记就是假药吗？", "en": "Does an imprint other than C5 mean counterfeit?" }, "answer": { "zh": "不能这样判断。当前官方标签本身就列出 C5 和 SP 两种印记、两个 NDC；其他厂家和市场还可能不同。网页图像与 OCR 不能鉴定真伪，应通过药师、授权供应链和当地监管渠道核验。", "en": "No. The current official label itself lists both C5 and SP imprints with different NDCs, and other manufacturers or markets may differ. Website images and OCR cannot authenticate a medicine; use a pharmacist, authorised supply chain and local regulator." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "dose-unit-literacy", "same-class-is-not-same-medicine", "interactions-are-not-a-home-scheduling-problem" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/clarinex-desloratadine/", "en": "https://origindrug.com/en/drugs/clarinex-desloratadine/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "xyzal-levocetirizine", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-09-03", "status": "published_traceable_archive" }, "names": { "brand": "XYZAL", "generic": "盐酸左西替利嗪片与口服溶液", "aliases": [ "Xyzal", "Xyzal Allergy 24HR", "levocetirizine", "levocetirizine dihydrochloride", "左西替利嗪", "盐酸左西替利嗪", "盐酸左西替利嗪片", "左旋西替利嗪", "XYZAL", "NDA 022064", "NDA 022157", "NDA 209089", "0024-5803-90", "0024-5804-05", "41167-3510-0", "41167-3510-1", "41167-3511-2" ], "marketBrandNames": [ { "name": "XYZAL", "market": { "zh": "美国处方产品", "en": "U.S. prescription product" }, "evidenceStatus": "current_regulatory_record", "note": { "zh": "NDA 022064/022157；5 mg 片与 0.5 mg/mL 口服液。", "en": "NDA 022064/022157; 5 mg tablets and 0.5 mg/mL oral solution." }, "source": { "id": "src_a25547ae6383083a", "label": "DailyMed（NLM）：XYZAL 左西替利嗪当前美国处方标签（2025-07 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=1673f7ff-0c7c-4403-86cf-c05eb1475222", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-03", "reviewedAt": "2026-09-03" } }, { "name": "XYZAL ALLERGY 24HR", "market": { "zh": "美国非处方产品", "en": "U.S. nonprescription product" }, "evidenceStatus": "current_regulatory_record", "note": { "zh": "NDA 209089；5 mg 普通口服片，多种独立包装。", "en": "NDA 209089; 5 mg immediate-release oral tablets in distinct packs." }, "source": { "id": "src_24d87dd00ec75624", "label": "DailyMed（NLM）：XYZAL ALLERGY 24HR 左西替利嗪当前美国 OTC Drug Facts 与包装面板（SPL v14，2026-03）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8be45c2a-1eca-4a00-81b9-f7babdbdcd41", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-03", "reviewedAt": "2026-09-03" } } ], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "呼吸系统", "sourceArchiveMarket": "美国当前公开记录包括处方 XYZAL 5 mg 片与 0.5 mg/mL 口服液，以及 OTC XYZAL ALLERGY 24HR 5 mg 片。处方与 OTC 的适用人群、用法文字、NDC 和包装不同；页面不把美国记录外推为中国或其他市场的批准、法律分类、库存或个人适用性。", "dosageFormClass": "普通口服片与口服溶液。5 mg 是每片含量；2.5 mg/5 mL 与 0.5 mg/mL 是同一口服液浓度的两种写法。片剂数字、液体浓度、瓶装/泡罩片数不能相加，也不能自行换成个人片数或毫升数。", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "2007（XYZAL 片 NDA 022064 获批；2017 年 OTC 转换获批）", "archiveSponsorText": "UCB（商标/产品历史）；Sanofi/Chattem（当前美国公开标签）" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [ "XYZAL levocetirizine", "XYZAL ALLERGY 24HR", "盐酸左西替利嗪片" ], "excludedProductCues": [ "ZYRTEC", "cetirizine", "西替利嗪", "BENADRYL", "diphenhydramine", "氯雷他定", "loratadine", "ALLEGRA", "fexofenadine" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-rx-xyzal-levocetirizine-tablet-5mg-90-bottle-ndc-0024-5803-90", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国处方品牌标签（2025-07 修订）", "en": "Current U.S. prescription brand label (revised Jul 2025)" }, "dosageForm": { "zh": "XYZAL 左西替利嗪处方用普通薄膜衣片", "en": "XYZAL prescription immediate-release film-coated tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 0024-5803-90", "pouchCode": null, "applicationNumber": "NDA 022064", "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片盐酸左西替利嗪 5 mg；90 片瓶装", "en": "Levocetirizine dihydrochloride 5 mg per tablet; 90-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=xyzal-03.jpg&setid=1673f7ff-0c7c-4403-86cf-c05eb1475222&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "盐酸左西替利嗪", "en": "levocetirizine dihydrochloride" }, "value": 5, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是所有人的片数、频率、停用或恢复方案", "en": "labelled amount per tablet; not a universal tablet count, frequency, stopping or restart plan" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 90, "countUnit": { "zh": "片/包装", "en": "tablets per pack" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-03", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "current_regulatory_listing_not_live_stock", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 90, "unit": { "zh": "片/包装", "en": "tablets per pack" } }, "physicalClues": { "color": { "zh": "白色", "en": "white" }, "shape": { "zh": "椭圆形、有刻痕片；刻痕是准确产品线索，不是所有人自行掰片的通用许可", "en": "oval scored tablet; the score is an exact-product clue, not universal permission to self-split" }, "imprint": { "zh": "Y / Y（红色）", "en": "Y / Y (red)" }, "scoreStatus": "scored_exact_label_not_universal_self_split_permission", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_a25547ae6383083a", "label": "DailyMed（NLM）：XYZAL 左西替利嗪当前美国处方标签（2025-07 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=1673f7ff-0c7c-4403-86cf-c05eb1475222", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-03", "reviewedAt": "2026-09-03" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-rx-xyzal-levocetirizine-oral-solution-0-5mg-per-ml-5floz-ndc-0024-5804-05", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国处方品牌标签（2025-07 修订）", "en": "Current U.S. prescription brand label (revised Jul 2025)" }, "dosageForm": { "zh": "XYZAL 左西替利嗪处方用口服溶液", "en": "XYZAL prescription oral solution" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 0024-5804-05", "pouchCode": null, "applicationNumber": "NDA 022157", "presentationRole": null, "primaryStrengthBasisCode": "per_5_mL", "primaryDisplay": { "zh": "每 5 mL 含盐酸左西替利嗪 2.5 mg（0.5 mg/mL）；5 液量盎司瓶装", "en": "Levocetirizine dihydrochloride 2.5 mg per 5 mL (0.5 mg/mL); 5 fl oz bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=xyzal-02.jpg&setid=1673f7ff-0c7c-4403-86cf-c05eb1475222&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "盐酸左西替利嗪", "en": "levocetirizine dihydrochloride" }, "value": 2.5, "unit": "mg", "basisCode": "per_5_mL", "basisLabel": { "zh": "每 5 mL 标签标示量；0.5 mg/mL 是浓度，不是个人量取方案", "en": "labelled amount per 5 mL; 0.5 mg/mL is a concentration, not an individual measuring plan" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "聚丙烯瓶", "en": "polypropylene bottle" }, "fill": null, "countPerPackage": 5, "countUnit": { "zh": "液量盎司/瓶", "en": "fl oz per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-03", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "current_regulatory_listing_not_live_stock", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 5, "unit": { "zh": "液量盎司/瓶", "en": "fl oz per bottle" } }, "physicalClues": { "color": { "zh": "无色溶液", "en": "colourless solution" }, "shape": { "zh": "口服液体；必须使用适合的量取工具", "en": "oral liquid; an appropriate measuring device is required" }, "imprint": { "zh": "不适用", "en": "not applicable" }, "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_a25547ae6383083a", "label": "DailyMed（NLM）：XYZAL 左西替利嗪当前美国处方标签（2025-07 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=1673f7ff-0c7c-4403-86cf-c05eb1475222", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-03", "reviewedAt": "2026-09-03" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-otc-xyzal-allergy-24hr-5mg-10-blister-ndc-41167-3510-0", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国 OTC Drug Facts（2026-03）", "en": "Current U.S. OTC Drug Facts (Mar 2026)" }, "dosageForm": { "zh": "XYZAL ALLERGY 24HR 左西替利嗪非处方普通片", "en": "XYZAL ALLERGY 24HR nonprescription immediate-release tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 41167-3510-0", "pouchCode": null, "applicationNumber": "NDA 209089", "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片盐酸左西替利嗪 5 mg；10 片泡罩装", "en": "Levocetirizine dihydrochloride 5 mg per tablet; 10-tablet blister pack" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=xyzal-allergy-24hr-01.jpg&setid=8be45c2a-1eca-4a00-81b9-f7babdbdcd41&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "盐酸左西替利嗪", "en": "levocetirizine dihydrochloride" }, "value": 5, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是所有人的片数、频率、停用或恢复方案", "en": "labelled amount per tablet; not a universal tablet count, frequency, stopping or restart plan" } } ], "concentration": null, "container": { "typeCode": "blister", "typeLabel": { "zh": "泡罩装", "en": "blister pack" }, "fill": null, "countPerPackage": 10, "countUnit": { "zh": "片/包装", "en": "tablets per pack" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-03", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "current_regulatory_listing_not_live_stock", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 10, "unit": { "zh": "片/包装", "en": "tablets per pack" } }, "physicalClues": { "color": { "zh": "白色", "en": "white" }, "shape": { "zh": "椭圆形、有刻痕片；刻痕是准确产品线索，不是所有人自行掰片的通用许可", "en": "oval scored tablet; the score is an exact-product clue, not universal permission to self-split" }, "imprint": { "zh": "X / X", "en": "X / X" }, "scoreStatus": "scored_exact_label_not_universal_self_split_permission", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_24d87dd00ec75624", "label": "DailyMed（NLM）：XYZAL ALLERGY 24HR 左西替利嗪当前美国 OTC Drug Facts 与包装面板（SPL v14，2026-03）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8be45c2a-1eca-4a00-81b9-f7babdbdcd41", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-03", "reviewedAt": "2026-09-03" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-otc-xyzal-allergy-24hr-5mg-35-bottle-ndc-41167-3510-1", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国 OTC Drug Facts（2026-03）", "en": "Current U.S. OTC Drug Facts (Mar 2026)" }, "dosageForm": { "zh": "XYZAL ALLERGY 24HR 左西替利嗪非处方普通片", "en": "XYZAL ALLERGY 24HR nonprescription immediate-release tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 41167-3510-1", "pouchCode": null, "applicationNumber": "NDA 209089", "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片盐酸左西替利嗪 5 mg；35 片瓶装", "en": "Levocetirizine dihydrochloride 5 mg per tablet; 35-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=xyzal-allergy-24hr-02.jpg&setid=8be45c2a-1eca-4a00-81b9-f7babdbdcd41&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "盐酸左西替利嗪", "en": "levocetirizine dihydrochloride" }, "value": 5, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是所有人的片数、频率、停用或恢复方案", "en": "labelled amount per tablet; not a universal tablet count, frequency, stopping or restart plan" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 35, "countUnit": { "zh": "片/包装", "en": "tablets per pack" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-03", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "current_regulatory_listing_not_live_stock", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 35, "unit": { "zh": "片/包装", "en": "tablets per pack" } }, "physicalClues": { "color": { "zh": "白色", "en": "white" }, "shape": { "zh": "椭圆形、有刻痕片；刻痕是准确产品线索，不是所有人自行掰片的通用许可", "en": "oval scored tablet; the score is an exact-product clue, not universal permission to self-split" }, "imprint": { "zh": "X / X", "en": "X / X" }, "scoreStatus": "scored_exact_label_not_universal_self_split_permission", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_24d87dd00ec75624", "label": "DailyMed（NLM）：XYZAL ALLERGY 24HR 左西替利嗪当前美国 OTC Drug Facts 与包装面板（SPL v14，2026-03）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8be45c2a-1eca-4a00-81b9-f7babdbdcd41", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-03", "reviewedAt": "2026-09-03" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-otc-xyzal-allergy-24hr-5mg-20-blister-ndc-41167-3511-2", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国 OTC Drug Facts（2026-03）", "en": "Current U.S. OTC Drug Facts (Mar 2026)" }, "dosageForm": { "zh": "XYZAL ALLERGY 24HR 左西替利嗪非处方普通片", "en": "XYZAL ALLERGY 24HR nonprescription immediate-release tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 41167-3511-2", "pouchCode": null, "applicationNumber": "NDA 209089", "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片盐酸左西替利嗪 5 mg；20 片泡罩装", "en": "Levocetirizine dihydrochloride 5 mg per tablet; 20-tablet blister pack" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=xyzal-allergy-24hr-03.jpg&setid=8be45c2a-1eca-4a00-81b9-f7babdbdcd41&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "盐酸左西替利嗪", "en": "levocetirizine dihydrochloride" }, "value": 5, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是所有人的片数、频率、停用或恢复方案", "en": "labelled amount per tablet; not a universal tablet count, frequency, stopping or restart plan" } } ], "concentration": null, "container": { "typeCode": "blister", "typeLabel": { "zh": "泡罩装", "en": "blister pack" }, "fill": null, "countPerPackage": 20, "countUnit": { "zh": "片/包装", "en": "tablets per pack" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-03", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "current_regulatory_listing_not_live_stock", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 20, "unit": { "zh": "片/包装", "en": "tablets per pack" } }, "physicalClues": { "color": { "zh": "白色", "en": "white" }, "shape": { "zh": "椭圆形、有刻痕片；刻痕是准确产品线索，不是所有人自行掰片的通用许可", "en": "oval scored tablet; the score is an exact-product clue, not universal permission to self-split" }, "imprint": { "zh": "X / X", "en": "X / X" }, "scoreStatus": "scored_exact_label_not_universal_self_split_permission", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_24d87dd00ec75624", "label": "DailyMed（NLM）：XYZAL ALLERGY 24HR 左西替利嗪当前美国 OTC Drug Facts 与包装面板（SPL v14，2026-03）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8be45c2a-1eca-4a00-81b9-f7babdbdcd41", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-03", "reviewedAt": "2026-09-03" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-rx-xyzal-levocetirizine-tablet-5mg-90-bottle-ndc-0024-5803-90", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=xyzal-03.jpg&setid=1673f7ff-0c7c-4403-86cf-c05eb1475222&type=img", "alt": "美国处方 XYZAL 盐酸左西替利嗪 5 mg、NDC 0024-5803-90、90 片瓶装的 DailyMed 官方标签面板", "archiveMarket": "美国", "labelVersion": "DailyMed 当前美国处方品牌标签（2025-07 修订）", "presentation": "处方 XYZAL 5 mg：每片 5 mg，白色椭圆形刻痕片，两侧红色 Y；NDC 0024-5803-90，90 片瓶装。", "notice": "此图只对应这一美国处方产品。它不代表 OTC 包装、口服液、ZYRTEC/西替利嗪、其他市场或实时库存，不用于鉴定真伪，也不生成个人片数或掰片方案。", "source": { "id": "src_a25547ae6383083a", "label": "DailyMed（NLM）：XYZAL 左西替利嗪当前美国处方标签（2025-07 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=1673f7ff-0c7c-4403-86cf-c05eb1475222", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-03", "reviewedAt": "2026-09-03" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "XYZAL 说明书放大阅读：每片 mg、液体浓度、嗜睡、肾功能与停用后瘙痒", "en": "XYZAL enlarged label: mg per tablet, liquid concentration, drowsiness, kidney function and itching after stopping" }, "summary": { "zh": "处方与 OTC XYZAL 不是一张可混用的说明。5 mg 是每片量；2.5 mg/5 mL 等于 0.5 mg/mL，是口服液浓度。网页帮助把产品和风险问题说准确，不计算个人片数、毫升数、掰片、停用或恢复方案。", "en": "Prescription and OTC XYZAL do not share one interchangeable instruction set. Five mg is the amount per tablet; 2.5 mg/5 mL equals 0.5 mg/mL and describes the oral-solution concentration. The site clarifies product and safety questions but does not calculate an individual's tablets, millilitres, splitting, stopping or restart plan." }, "checks": [ { "zh": "美国 OTC Drug Facts 把 65 岁及以上、肾病、既往排尿困难或膀胱排空困难分别列为先咨询或不使用边界；处方标签也强调肾排泄和排尿潴留风险。老人不能只因“是非处方药”就把它当成人人都能自行使用。", "en": "U.S. OTC Drug Facts separately flags age 65 or older, kidney disease, and prior trouble urinating or emptying the bladder for professional review or non-use; the prescription label also emphasizes renal excretion and urinary-retention risk. An OTC status does not make the product suitable for every older adult." }, { "zh": "嗜睡、疲劳和反应下降可能影响驾驶、操作设备和跌倒风险；酒精、安眠药、镇静药及其他中枢抑制物可能进一步降低警觉。不要靠自行错开时间来假定风险消失，应把所有处方药、OTC 感冒/过敏药和酒精一起列给药师或医生。", "en": "Drowsiness, fatigue and reduced alertness can affect driving, machinery and falls; alcohol, sleep medicines, sedatives and other CNS depressants may further reduce alertness. Do not assume self-spacing removes the risk; list every prescription, OTC cold/allergy product and alcohol use for a pharmacist or clinician." }, { "zh": "FDA 2025 通讯说明，长期每日使用后几天内停用可能出现罕见但可能严重的全身瘙痒。该信息不是自行突然停用、恢复或递减的操作指南；计划长期使用或停用后出现严重瘙痒时，应联系当地专业人员。", "en": "FDA's 2025 communication says rare but potentially severe widespread itching may begin within days after stopping long-term daily use. This is not a self-directed abrupt-stop, restart or taper guide. Discuss planned long-term use, and contact a local professional if severe itching appears after stopping." }, { "zh": "处方片有刻痕、OTC 标签对特定年龄段写有半片文字，但这只属于对应美国准确产品和标签人群。不能把刻痕推广成任何左西替利嗪、任何市场或任何人都可自行掰半；更不能把口服液浓度直接换成片数。", "en": "The prescription tablet is scored and the OTC label contains half-tablet wording for defined U.S. label populations, but this belongs only to those exact products and populations. A score does not give universal permission to split any levocetirizine product in any market, and oral-solution concentration must not be converted directly into a tablet count." } ], "source": { "id": "src_a25547ae6383083a", "label": "DailyMed（NLM）：XYZAL 左西替利嗪当前美国处方标签（2025-07 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=1673f7ff-0c7c-4403-86cf-c05eb1475222", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-03", "reviewedAt": "2026-09-03" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "左西替利嗪怎样起作用：阻断外周 H1 受体，不等于所有抗组胺药可以换算", "en": "How levocetirizine works: peripheral H1-receptor blockade does not make antihistamines interchangeable" }, "summary": { "zh": "标签将左西替利嗪描述为口服 H1 受体拮抗剂，是西替利嗪的 R-对映体。该机制解释过敏症状通路，不判断症状一定由过敏引起，也不建立与西替利嗪、氯雷他定、非索非那定或苯海拉明的 mg 换算、叠加或轮换规则。", "en": "The label describes levocetirizine as an oral H1-receptor antagonist and the R-enantiomer of cetirizine. This explains an allergy pathway; it neither proves symptoms are allergic nor creates milligram conversion, combination or rotation rules with cetirizine, loratadine, fexofenadine or diphenhydramine." }, "checks": [ { "zh": "“第二代”或“不那么嗜睡”不是没有嗜睡。个体反应、年龄、肾功能、酒精和其他镇静药都需要一起核对。", "en": "‘Second generation’ or ‘less sedating’ does not mean no drowsiness. Individual response, age, kidney function, alcohol and other sedatives need review together." }, { "zh": "XYZAL 与 ZYRTEC 成分相关但不是同一个准确产品；共同机制不表示可以同服、隔天轮换、按 mg 对换或互相补服。", "en": "XYZAL and ZYRTEC are related in chemistry but are not the same exact product. A shared mechanism does not permit co-use, alternate-day rotation, milligram exchange or make-up use with one another." }, { "zh": "鼻塞、皮疹、瘙痒或流涕也可能有其他原因；呼吸困难、面唇舌喉肿胀、意识改变或其他严重症状应立即使用当地急救渠道，而不是继续在网页比较抗过敏药。", "en": "Congestion, rash, itching or a runny nose can have other causes. Trouble breathing, swelling of the face/lips/tongue/throat, altered awareness or another severe symptom requires local emergency help rather than continued website comparison of allergy medicines." } ], "source": { "id": "src_a25547ae6383083a", "label": "DailyMed（NLM）：XYZAL 左西替利嗪当前美国处方标签（2025-07 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=1673f7ff-0c7c-4403-86cf-c05eb1475222", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-03", "reviewedAt": "2026-09-03" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "XYZAL", "generic": "盐酸左西替利嗪片与口服溶液", "dosageFormClass": "普通口服片与口服溶液。5 mg 是每片含量；2.5 mg/5 mL 与 0.5 mg/mL 是同一口服液浓度的两种写法。片剂数字、液体浓度、瓶装/泡罩片数不能相加，也不能自行换成个人片数或毫升数。" }, "labelSource": { "id": "src_a25547ae6383083a", "label": "DailyMed（NLM）：XYZAL 左西替利嗪当前美国处方标签（2025-07 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=1673f7ff-0c7c-4403-86cf-c05eb1475222", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-03", "reviewedAt": "2026-09-03" }, "productRoutes": [ { "source": { "id": "src_a25547ae6383083a", "label": "DailyMed（NLM）：XYZAL 左西替利嗪当前美国处方标签（2025-07 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=1673f7ff-0c7c-4403-86cf-c05eb1475222", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-03", "reviewedAt": "2026-09-03" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-09-03", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_24d87dd00ec75624", "label": "DailyMed（NLM）：XYZAL ALLERGY 24HR 左西替利嗪当前美国 OTC Drug Facts 与包装面板（SPL v14，2026-03）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8be45c2a-1eca-4a00-81b9-f7babdbdcd41", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-03", "reviewedAt": "2026-09-03" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-09-03", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-09-03", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [ { "id": "fda-2025-levocetirizine-xyzal-pruritus-after-stopping-safety-communication", "issuedAt": "2025-05-16", "status": "fda_drug_safety_communication", "title": { "zh": "FDA 药物安全通讯：停止长期使用口服左西替利嗪／XYZAL 后罕见但可能严重的瘙痒", "en": "FDA Drug Safety Communication: rare but severe itching after stopping long-term oral levocetirizine/XYZAL" }, "summary": { "zh": "FDA 于 2025-05-16 说明，长期规律使用口服左西替利嗪或西替利嗪后停用，可能出现罕见但可能严重的瘙痒；通讯覆盖美国处方与非处方产品并要求标签更新。该监管记录不能判断任何个人是否会发生问题，也不提供自行停用、恢复、递减、换药或与另一种抗组胺药叠加的方案。计划长期使用或停用后出现严重瘙痒时，请带实际包装和完整药单联系当地药师、开方团队或医疗服务。", "en": "On 16 May 2025, FDA said rare but potentially severe itching can occur after stopping long-term regular use of oral levocetirizine or cetirizine; the communication covers U.S. prescription and nonprescription products and requires label updates. This regulator record cannot predict an individual event or provide a self-directed stop, restart, taper, switch or antihistamine-combination plan. Discuss planned long-term use, and contact a local pharmacist, prescriber or medical service with the actual pack and complete medicine list if severe itching appears after stopping." }, "source": { "id": "src_72aeda1f7f249ce3", "label": "FDA：2025-05-16 停止长期使用口服左西替利嗪／XYZAL 后瘙痒的药物安全通讯", "url": "https://www.fda.gov/drugs/drug-safety-communications/fda-requires-warning-about-rare-severe-itching-after-stopping-long-term-use-oral-allergy-medicines", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-03", "reviewedAt": "2026-09-03" } } ], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "XYZAL 是左西替利嗪品牌档案。老人、多药使用者和有肾功能或排尿问题者，应优先核对嗜睡、酒精/镇静药叠加、驾驶跌倒、排尿困难和停用长期规律用药后新发严重瘙痒。网页解释“每片 mg、每 5 mL、mg/mL、包装片数”的区别，不替个人决定吃几片、量几毫升、是否掰片、停用、恢复或换成另一种抗过敏药。", "history": "FDA 资料显示，XYZAL 处方片于 2007 年获批，口服液于 2008 年获批，2017 年完成 OTC 转换。FDA 于 2025-05-16 发布安全通讯，要求处方与 OTC 口服西替利嗪/左西替利嗪标签加入长期使用后停用可能出现罕见但严重瘙痒的警示。", "sourceDocuments": [ { "id": "src_a25547ae6383083a", "label": "DailyMed（NLM）：XYZAL 左西替利嗪当前美国处方标签（2025-07 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=1673f7ff-0c7c-4403-86cf-c05eb1475222", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-03", "reviewedAt": "2026-09-03" }, { "id": "src_24d87dd00ec75624", "label": "DailyMed（NLM）：XYZAL ALLERGY 24HR 左西替利嗪当前美国 OTC Drug Facts 与包装面板（SPL v14，2026-03）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8be45c2a-1eca-4a00-81b9-f7babdbdcd41", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-03", "reviewedAt": "2026-09-03" }, { "id": "src_72aeda1f7f249ce3", "label": "FDA：2025-05-16 停止长期使用口服西替利嗪或左西替利嗪后罕见但可能严重瘙痒的药物安全通讯", "url": "https://www.fda.gov/drugs/drug-safety-communications/fda-requires-warning-about-rare-severe-itching-after-stopping-long-term-use-oral-allergy-medicines", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-03", "reviewedAt": "2026-09-03" }, { "id": "src_77cac6b160e47365", "label": "FDA：XYZAL ALLERGY 24HR NDA 209089/209090 OTC 转换审评资料（2017）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/209089Orig1s000_209090Orig1s000OtherR.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_regulatory_document", "documentKind": "regulatory_review", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-03", "reviewedAt": "2026-09-03" } ], "applicationNumber": "NDA 022064 / NDA 022157 / NDA 209089", "approvalTimeline": [ { "date": "2007", "title": { "zh": "XYZAL 处方片在美国获批", "en": "U.S. approval of prescription XYZAL tablets" }, "detail": { "zh": "FDA 儿科审评资料将 NDA 022064 与 2007 年左西替利嗪片批准相连。", "en": "FDA pediatric review links NDA 022064 to the 2007 approval of levocetirizine tablets." }, "source": { "id": "src_77cac6b160e47365", "label": "FDA：XYZAL ALLERGY 24HR NDA 209089/209090 OTC 转换审评资料（2017）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/209089Orig1s000_209090Orig1s000OtherR.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_regulatory_document", "documentKind": "regulatory_review", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-03", "reviewedAt": "2026-09-03" } }, { "date": "2017-01-31", "title": { "zh": "XYZAL ALLERGY 24HR 完成美国 OTC 转换", "en": "U.S. OTC switch for XYZAL ALLERGY 24HR" }, "detail": { "zh": "NDA 209089 的 OTC 审评资料覆盖 5 mg 抗组胺片。", "en": "The NDA 209089 OTC review covers the 5 mg antihistamine tablet." }, "source": { "id": "src_77cac6b160e47365", "label": "FDA：XYZAL ALLERGY 24HR NDA 209089/209090 OTC 转换审评资料（2017）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/209089Orig1s000_209090Orig1s000OtherR.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_regulatory_document", "documentKind": "regulatory_review", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-03", "reviewedAt": "2026-09-03" } }, { "date": "2025-05-16", "title": { "zh": "FDA 发布停用后严重瘙痒安全通讯", "en": "FDA issued its severe-itching-after-stopping communication" }, "detail": { "zh": "通讯涵盖处方和 OTC 口服西替利嗪/左西替利嗪，并要求标签更新。", "en": "The communication covers prescription and OTC oral cetirizine/levocetirizine and requires label updates." }, "source": { "id": "src_72aeda1f7f249ce3", "label": "FDA：2025-05-16 停止长期使用口服西替利嗪或左西替利嗪后罕见但可能严重瘙痒的药物安全通讯", "url": "https://www.fda.gov/drugs/drug-safety-communications/fda-requires-warning-about-rare-severe-itching-after-stopping-long-term-use-oral-allergy-medicines", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-03", "reviewedAt": "2026-09-03" } } ], "marketStatus": [ { "market": { "zh": "美国处方", "en": "U.S. prescription" }, "status": { "zh": "当前公开标签", "en": "Current public label" }, "detail": { "zh": "5 mg 片与 0.5 mg/mL 口服液；NDA 022064/022157。", "en": "5 mg tablets and 0.5 mg/mL oral solution; NDA 022064/022157." } }, { "market": { "zh": "美国 OTC", "en": "U.S. OTC" }, "status": { "zh": "当前 Drug Facts 与包装记录", "en": "Current Drug Facts and package records" }, "detail": { "zh": "XYZAL ALLERGY 24HR 5 mg 片；NDA 209089。", "en": "XYZAL ALLERGY 24HR 5 mg tablets; NDA 209089." } }, { "market": { "zh": "美国以外", "en": "Outside the United States" }, "status": { "zh": "本档案未确认当地产品", "en": "Local products not established in this dossier" }, "detail": { "zh": "必须回到当地监管记录和手中药盒，不沿用美国 OTC/处方边界。", "en": "Check the local regulator and pack in hand; do not carry U.S. OTC/prescription boundaries across markets." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "5 mg 是一天一定吃一片吗？", "en": "Does 5 mg always mean one tablet a day?" }, "answer": { "zh": "不是。5 mg 是这款片剂每片的标签量；个人是否使用、片数、频率及是否可掰片取决于准确产品、所在市场、年龄、肾功能和专业判断，网页不把规格变成处方。", "en": "No. Five mg is the labelled amount in one tablet. Whether to use it, tablet count, frequency and splitting depend on the exact product, market, age, kidney function and professional review; the site does not turn strength into a prescription." } }, { "question": { "zh": "能和 ZYRTEC、西替利嗪或其他抗过敏药一起吃吗？", "en": "Can it be taken with ZYRTEC, cetirizine or another allergy medicine?" }, "answer": { "zh": "不能由网页这样决定。名称、类别或机制相关不等于可以叠加、轮换或换算；把所有处方和 OTC 感冒/过敏药的完整成分表交给药师或医生核对，避免同成分或同作用重复。", "en": "A website cannot make that decision. Related names, class or mechanism do not permit combination, rotation or conversion. Give a pharmacist or clinician the full ingredient lists for every prescription and OTC cold/allergy product to check for duplication." } }, { "question": { "zh": "长期每天吃后可以突然停吗？", "en": "Can long-term daily use be stopped suddenly?" }, "answer": { "zh": "FDA 已提醒长期规律使用后停用可能出现罕见但严重瘙痒，但该通讯不是网页递减或恢复方案。计划长期使用或停用前请咨询专业人员；停用后出现严重瘙痒应尽快联系医疗支持。", "en": "FDA warns that rare but severe itching can occur after stopping long-term regular use, but the communication is not a website taper or restart plan. Discuss planned long-term use or stopping with a professional, and seek prompt help for severe itching after stopping." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "dose-unit-literacy", "same-class-is-not-same-medicine", "interactions-are-not-a-home-scheduling-problem" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/xyzal-levocetirizine/", "en": "https://origindrug.com/en/drugs/xyzal-levocetirizine/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "hytrin-terazosin", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-09-02", "status": "published_traceable_archive" }, "names": { "brand": "HYTRIN", "generic": "盐酸特拉唑嗪胶囊", "aliases": [ "Hytrin", "terazosin", "terazosin hydrochloride", "特拉唑嗪", "盐酸特拉唑嗪", "高特灵", "HYTRIN", "terazosin capsules", "盐酸特拉唑嗪胶囊", "NDA 019057", "NDA 020347", "ANDA 074823", "24689-001-01", "24689-002-01", "24689-003-01", "24689-004-01" ], "marketBrandNames": [ { "name": "HYTRIN", "market": { "zh": "美国", "en": "United States" }, "evidenceStatus": "historical_originator_rld_discontinued", "note": { "zh": "NDA 019057（片）与 NDA 020347（胶囊）；历史 1、2、5、10 mg，现均停市。", "en": "NDA 019057 (tablets) and NDA 020347 (capsules); historical 1, 2, 5 and 10 mg products, now discontinued." }, "source": { "id": "src_7d2d3c7c5f8a9778", "label": "FDA：TEZRULY 临床审评中的 HYTRIN 特定批准史（NDA 019057／020347；2025）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2025/218139Orig1s000MedR.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_regulatory_document", "documentKind": "regulatory_review", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" } } ], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "泌尿健康", "sourceArchiveMarket": "FDA 2025 审评确认 HYTRIN 片 NDA 019057 于 1987-08-07 首次批准，HYTRIN 胶囊 NDA 020347 于 1994-12-14 批准；历史 1、2、5、10 mg 产品均已停市，监管记录说明并非因安全性或有效性撤回。页面四张准确图片来自 ANDA 074823 当前通用药，绝不能当作 HYTRIN 原品牌外观、实时库存或真伪证明。", "dosageFormClass": "历史 HYTRIN 包括普通口服片与胶囊；当前页面的准确包装比较项是盐酸特拉唑嗪通用药胶囊。TEZRULY 是 1 mg/mL 口服液，剂型、浓度、申请号和量取方式不同，不能按共同成分自行换算或替换。", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "1987（美国首次批准 HYTRIN 片；1994 批准胶囊）", "archiveSponsorText": "Abbott（HYTRIN 历史 NDA 申请人）" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [ "HYTRIN", "Hytrin terazosin", "盐酸特拉唑嗪胶囊", "特拉唑嗪胶囊", "高特灵" ], "excludedProductCues": [ "TEZRULY", "terazosin oral solution", "特拉唑嗪口服液", "FLOMAX", "tamsulosin", "RAPAFLO", "silodosin", "UROXATRAL", "alfuzosin", "CARDURA", "doxazosin", "MINIPRESS", "prazosin" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-generic-terazosin-1mg-100-capsule-bottle-ndc-2468900101", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国通用药标签（2026-08-08 更新）", "en": "Current U.S. generic DailyMed label (updated 8 Aug 2026)" }, "dosageForm": { "zh": "盐酸特拉唑嗪通用药口服胶囊（不是 HYTRIN 原品牌包装）", "en": "Generic terazosin hydrochloride oral capsule (not an original-brand HYTRIN pack)" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 24689-001-01", "pouchCode": null, "applicationNumber": "ANDA 074823", "presentationRole": null, "primaryStrengthBasisCode": "per_capsule", "primaryDisplay": { "zh": "每粒特拉唑嗪 1 mg；100 粒瓶装；当前通用药比较项", "en": "Terazosin 1 mg per capsule; 100-capsule bottle; current generic comparator" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=3c52c76c-d0ca-46e7-bd3c-6192b20c995d-01.jpg&setid=619dd5cb-46fb-4ad9-a05f-f064261a636b&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "特拉唑嗪（以盐酸盐形式）", "en": "terazosin (as hydrochloride)" }, "value": 1, "unit": "mg", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒标签标示量；不是个人粒数、起始量、恢复方案或同类药换算值", "en": "labelled amount per capsule; not an individual's capsule count, starting amount, restart plan or alpha-blocker conversion" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-02", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "current_generic_regulatory_listing_not_live_stock", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_6b85228472475598", "label": "DailyMed（NLM）：Apnar 盐酸特拉唑嗪当前通用药四个准确包装面板（ANDA 074823）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=619dd5cb-46fb-4ad9-a05f-f064261a636b", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-generic-terazosin-2mg-100-capsule-bottle-ndc-2468900201", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国通用药标签（2026-08-08 更新）", "en": "Current U.S. generic DailyMed label (updated 8 Aug 2026)" }, "dosageForm": { "zh": "盐酸特拉唑嗪通用药口服胶囊（不是 HYTRIN 原品牌包装）", "en": "Generic terazosin hydrochloride oral capsule (not an original-brand HYTRIN pack)" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 24689-002-01", "pouchCode": null, "applicationNumber": "ANDA 074823", "presentationRole": null, "primaryStrengthBasisCode": "per_capsule", "primaryDisplay": { "zh": "每粒特拉唑嗪 2 mg；100 粒瓶装；当前通用药比较项", "en": "Terazosin 2 mg per capsule; 100-capsule bottle; current generic comparator" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=3c52c76c-d0ca-46e7-bd3c-6192b20c995d-02.jpg&setid=619dd5cb-46fb-4ad9-a05f-f064261a636b&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "特拉唑嗪（以盐酸盐形式）", "en": "terazosin (as hydrochloride)" }, "value": 2, "unit": "mg", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒标签标示量；不是个人粒数、起始量、恢复方案或同类药换算值", "en": "labelled amount per capsule; not an individual's capsule count, starting amount, restart plan or alpha-blocker conversion" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-02", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "current_generic_regulatory_listing_not_live_stock", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_6b85228472475598", "label": "DailyMed（NLM）：Apnar 盐酸特拉唑嗪当前通用药四个准确包装面板（ANDA 074823）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=619dd5cb-46fb-4ad9-a05f-f064261a636b", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-generic-terazosin-5mg-100-capsule-bottle-ndc-2468900301", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国通用药标签（2026-08-08 更新）", "en": "Current U.S. generic DailyMed label (updated 8 Aug 2026)" }, "dosageForm": { "zh": "盐酸特拉唑嗪通用药口服胶囊（不是 HYTRIN 原品牌包装）", "en": "Generic terazosin hydrochloride oral capsule (not an original-brand HYTRIN pack)" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 24689-003-01", "pouchCode": null, "applicationNumber": "ANDA 074823", "presentationRole": null, "primaryStrengthBasisCode": "per_capsule", "primaryDisplay": { "zh": "每粒特拉唑嗪 5 mg；100 粒瓶装；当前通用药比较项", "en": "Terazosin 5 mg per capsule; 100-capsule bottle; current generic comparator" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=3c52c76c-d0ca-46e7-bd3c-6192b20c995d-03.jpg&setid=619dd5cb-46fb-4ad9-a05f-f064261a636b&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "特拉唑嗪（以盐酸盐形式）", "en": "terazosin (as hydrochloride)" }, "value": 5, "unit": "mg", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒标签标示量；不是个人粒数、起始量、恢复方案或同类药换算值", "en": "labelled amount per capsule; not an individual's capsule count, starting amount, restart plan or alpha-blocker conversion" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-02", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "current_generic_regulatory_listing_not_live_stock", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_6b85228472475598", "label": "DailyMed（NLM）：Apnar 盐酸特拉唑嗪当前通用药四个准确包装面板（ANDA 074823）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=619dd5cb-46fb-4ad9-a05f-f064261a636b", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-generic-terazosin-10mg-100-capsule-bottle-ndc-2468900401", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国通用药标签（2026-08-08 更新）", "en": "Current U.S. generic DailyMed label (updated 8 Aug 2026)" }, "dosageForm": { "zh": "盐酸特拉唑嗪通用药口服胶囊（不是 HYTRIN 原品牌包装）", "en": "Generic terazosin hydrochloride oral capsule (not an original-brand HYTRIN pack)" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 24689-004-01", "pouchCode": null, "applicationNumber": "ANDA 074823", "presentationRole": null, "primaryStrengthBasisCode": "per_capsule", "primaryDisplay": { "zh": "每粒特拉唑嗪 10 mg；100 粒瓶装；当前通用药比较项", "en": "Terazosin 10 mg per capsule; 100-capsule bottle; current generic comparator" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=3c52c76c-d0ca-46e7-bd3c-6192b20c995d-04.jpg&setid=619dd5cb-46fb-4ad9-a05f-f064261a636b&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "特拉唑嗪（以盐酸盐形式）", "en": "terazosin (as hydrochloride)" }, "value": 10, "unit": "mg", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒标签标示量；不是个人粒数、起始量、恢复方案或同类药换算值", "en": "labelled amount per capsule; not an individual's capsule count, starting amount, restart plan or alpha-blocker conversion" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-02", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "current_generic_regulatory_listing_not_live_stock", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_6b85228472475598", "label": "DailyMed（NLM）：Apnar 盐酸特拉唑嗪当前通用药四个准确包装面板（ANDA 074823）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=619dd5cb-46fb-4ad9-a05f-f064261a636b", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-generic-terazosin-1mg-100-capsule-bottle-ndc-2468900101", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=3c52c76c-d0ca-46e7-bd3c-6192b20c995d-01.jpg&setid=619dd5cb-46fb-4ad9-a05f-f064261a636b&type=img", "alt": "盐酸特拉唑嗪 1 mg、NDC 24689-001-01、100 粒瓶装的当前通用药 DailyMed 标签面板；不是 HYTRIN 原品牌包装", "archiveMarket": "美国", "labelVersion": "DailyMed 当前通用药标签（2026-08-08 更新）", "presentation": "当前通用药准确包装比较：1、2、5、10 mg，均为 100 粒瓶装；四个 NDC 必须分开核对。", "notice": "图像仅对应 ANDA 074823 当前通用药，不能用于想象 HYTRIN 历史原品牌外观、确认实时有货，也不用于鉴定真伪。", "source": { "id": "src_6b85228472475598", "label": "DailyMed（NLM）：Apnar 盐酸特拉唑嗪当前通用药四个准确包装面板（ANDA 074823）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=619dd5cb-46fb-4ad9-a05f-f064261a636b", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "特拉唑嗪说明书放大阅读：先分清每粒 mg、整瓶粒数与首次/恢复使用风险", "en": "Enlarged terazosin label: separate per-capsule mg, bottle count and first/restart risk" }, "summary": { "zh": "1、2、5、10 mg 是每粒特拉唑嗪标示量；100 Capsules 是整瓶粒数。说明书对首次使用、增加强度以及中断数日后恢复时的明显降压、体位性低血压与晕厥作出重点警示；网页不把标签中的剂量段落转写成个人方案。", "en": "The 1, 2, 5 and 10 mg figures are labelled terazosin per capsule; 100 Capsules is the bottle count. The label prominently warns about marked blood-pressure lowering, orthostatic hypotension and syncope when starting, increasing a strength or restarting after several days; the site does not turn dosing text into an individual plan." }, "checks": [ { "zh": "老人、有跌倒史、夜间起身或同时使用其他降压药者，应把完整药单、近期是否中断和症状交给医生或药师核对。不要自行恢复、加量、错开或停掉一盒。", "en": "Older adults, people with falls, those rising at night or using another blood-pressure medicine should have the full list, recent interruption and symptoms reviewed. Do not self-restart, increase, separate or stop a pack." }, { "zh": "说明书记录特拉唑嗪与 PDE-5 抑制剂同用时出现低血压。CIALIS、VIAGRA 等出现在同一药单时，不要自己安排时间差或减量。", "en": "The label reports hypotension with PDE-5 inhibitors. If CIALIS, VIAGRA or a similar medicine is on the same list, do not self-design spacing or dose reductions." }, { "zh": "白内障手术前要主动告诉眼科团队现在或过去使用过特拉唑嗪/其他 α1 阻滞剂；标签指出自行停药未显示获益。", "en": "Before cataract surgery, tell the eye team about current or previous terazosin/other alpha-1 blocker use; the label says self-stopping has not shown benefit." }, { "zh": "晕厥或跌倒受伤需要及时医疗评估；持续数小时的疼痛勃起属于罕见但紧急的标签警示，应立即联系急诊服务。", "en": "Syncope or a fall with injury needs timely medical assessment. A painful erection lasting for hours is a rare but urgent labelled warning requiring immediate emergency care." } ], "source": { "id": "src_372f257d0ae163f9", "label": "DailyMed（NLM）：盐酸特拉唑嗪胶囊当前美国通用药标签、患者信息与用药警戒", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?audience=consumer&setid=68877160-c88e-4b4e-a61d-abd4dff96742", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "特拉唑嗪怎样起作用：阻断 α1 肾上腺素能受体，影响下尿路平滑肌与血管阻力", "en": "How terazosin works: alpha-1 adrenergic blockade affects lower-urinary-tract smooth muscle and vascular resistance" }, "summary": { "zh": "说明书解释，特拉唑嗪可放松前列腺与膀胱开口处平滑肌，帮助改善相关尿路症状；其血管作用也可降低血压。它不会缩小前列腺，也不治疗前列腺癌；相似症状仍需专业评估。", "en": "The label explains that terazosin relaxes smooth muscle in the prostate and bladder outlet, helping related urinary symptoms; its vascular effect can also lower blood pressure. It does not shrink the prostate or treat prostate cancer, and similar symptoms still need professional evaluation." }, "checks": [ { "zh": "HYTRIN、FLOMAX、RAPAFLO、UROXATRAL、CARDURA 与 MINIPRESS 不是同一种药。共同的 α 阻滞机制不建立 mg 换算、轮换、叠加或替换规则。", "en": "HYTRIN, FLOMAX, RAPAFLO, UROXATRAL, CARDURA and MINIPRESS are not one medicine. Related alpha blockade creates no milligram conversion, alternation, combination or substitution rule." }, { "zh": "HYTRIN 历史片剂、历史胶囊、当前通用药胶囊与 TEZRULY 口服液是不同准确产品；剂型和数字必须与手中药盒、处方和目标市场现行说明书一起核对。", "en": "Historical HYTRIN tablets, historical HYTRIN capsules, current generic capsules and TEZRULY oral solution are different exact products. Form and figures must be checked with the pack, prescription and current target-market label." }, { "zh": "作用机理不能替代血压、完整药单、跌倒史和个体评估，也不能根据夜尿或排尿困难自行判断该用哪一种药。", "en": "Mechanism does not replace blood pressure, the complete medicine list, fall history and individual assessment, or identify a medicine from nocturia or urinary difficulty alone." } ], "source": { "id": "src_372f257d0ae163f9", "label": "DailyMed（NLM）：盐酸特拉唑嗪胶囊当前美国通用药标签、患者信息与用药警戒", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?audience=consumer&setid=68877160-c88e-4b4e-a61d-abd4dff96742", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "HYTRIN", "generic": "盐酸特拉唑嗪胶囊", "dosageFormClass": "历史 HYTRIN 包括普通口服片与胶囊；当前页面的准确包装比较项是盐酸特拉唑嗪通用药胶囊。TEZRULY 是 1 mg/mL 口服液，剂型、浓度、申请号和量取方式不同，不能按共同成分自行换算或替换。" }, "labelSource": { "id": "src_372f257d0ae163f9", "label": "DailyMed（NLM）：盐酸特拉唑嗪胶囊当前美国通用药标签、患者信息与用药警戒", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?audience=consumer&setid=68877160-c88e-4b4e-a61d-abd4dff96742", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, "productRoutes": [ { "source": { "id": "src_372f257d0ae163f9", "label": "DailyMed（NLM）：盐酸特拉唑嗪胶囊当前美国通用药标签、患者信息与用药警戒", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?audience=consumer&setid=68877160-c88e-4b4e-a61d-abd4dff96742", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-09-02", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_272c697ae8339dce", "label": "DailyMed（NLM）：盐酸特拉唑嗪胶囊电子说明书 PDF（可放大阅读）", "url": "https://dailymed.nlm.nih.gov/dailymed/downloadpdffile.cfm?setId=68877160-c88e-4b4e-a61d-abd4dff96742", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-09-02", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_6b85228472475598", "label": "DailyMed（NLM）：Apnar 盐酸特拉唑嗪当前通用药四个准确包装面板（ANDA 074823）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=619dd5cb-46fb-4ad9-a05f-f064261a636b", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-09-02", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-09-02", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "HYTRIN 是特拉唑嗪的美国历史品牌档案。1、2、5、10 mg 是每粒含量，100 Capsules 是整瓶粒数，不是个人粒数或恢复用药方案。老人和多药使用者尤其要核对首次使用或中断后恢复时的突然降压、头晕、晕厥和跌倒，以及其他降压药、PDE-5 抑制剂和白内障手术信息；网页不替个人决定规格、时间、加量或换药。", "history": "FDA 资料显示，HYTRIN 片 NDA 019057 于 1987-08-07 获批，1993-09-29 增加良性前列腺增生相关批准，HYTRIN 胶囊 NDA 020347 于 1994-12-14 获批。片剂与胶囊后续均停市；FDA 审评引用的联邦公报结论为并非因安全性或有效性原因撤回。历史身份与当前可见通用药包装必须分开。", "sourceDocuments": [ { "id": "src_7d2d3c7c5f8a9778", "label": "FDA：TEZRULY 临床审评中的 HYTRIN 特定批准史（NDA 019057／020347；2025）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2025/218139Orig1s000MedR.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_regulatory_document", "documentKind": "regulatory_review", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, { "id": "src_372f257d0ae163f9", "label": "DailyMed（NLM）：盐酸特拉唑嗪胶囊当前美国通用药标签、患者信息与用药警戒", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?audience=consumer&setid=68877160-c88e-4b4e-a61d-abd4dff96742", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, { "id": "src_272c697ae8339dce", "label": "DailyMed（NLM）：盐酸特拉唑嗪胶囊电子说明书 PDF（可放大阅读）", "url": "https://dailymed.nlm.nih.gov/dailymed/downloadpdffile.cfm?setId=68877160-c88e-4b4e-a61d-abd4dff96742", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, { "id": "src_6b85228472475598", "label": "DailyMed（NLM）：Apnar 盐酸特拉唑嗪当前通用药四个准确包装面板（ANDA 074823）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=619dd5cb-46fb-4ad9-a05f-f064261a636b", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" } ], "applicationNumber": "NDA 019057 / NDA 020347", "approvalTimeline": [ { "date": "1987-08-07", "title": { "zh": "HYTRIN 片首次获 FDA 批准", "en": "FDA first approved HYTRIN tablets" }, "detail": { "zh": "NDA 019057；历史 1、2、5、10 mg 片。", "en": "NDA 019057; historical 1, 2, 5 and 10 mg tablets." }, "source": { "id": "src_7d2d3c7c5f8a9778", "label": "FDA：TEZRULY 临床审评中的 HYTRIN 特定批准史（NDA 019057／020347；2025）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2025/218139Orig1s000MedR.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_regulatory_document", "documentKind": "regulatory_review", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" } }, { "date": "1993-09-29", "title": { "zh": "增加 BPH 相关批准", "en": "BPH-related approval added" }, "detail": { "zh": "FDA 2025 审评记录的历史里程碑。", "en": "Historical milestone recorded in the 2025 FDA review." }, "source": { "id": "src_7d2d3c7c5f8a9778", "label": "FDA：TEZRULY 临床审评中的 HYTRIN 特定批准史（NDA 019057／020347；2025）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2025/218139Orig1s000MedR.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_regulatory_document", "documentKind": "regulatory_review", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" } }, { "date": "1994-12-14", "title": { "zh": "HYTRIN 胶囊获 FDA 批准", "en": "FDA approved HYTRIN capsules" }, "detail": { "zh": "NDA 020347；历史 1、2、5、10 mg 胶囊。", "en": "NDA 020347; historical 1, 2, 5 and 10 mg capsules." }, "source": { "id": "src_7d2d3c7c5f8a9778", "label": "FDA：TEZRULY 临床审评中的 HYTRIN 特定批准史（NDA 019057／020347；2025）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2025/218139Orig1s000MedR.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_regulatory_document", "documentKind": "regulatory_review", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" } } ], "marketStatus": [ { "market": { "zh": "美国 HYTRIN", "en": "U.S. HYTRIN" }, "status": { "zh": "历史原研/RLD 已停市", "en": "Historical originator/RLD, discontinued" }, "detail": { "zh": "FDA 审评说明停市并非安全性或有效性原因；不表示现在有货。", "en": "FDA review states discontinuation was not for safety or effectiveness; this does not indicate current stock." } }, { "market": { "zh": "美国通用药比较项", "en": "U.S. generic comparator" }, "status": { "zh": "当前公开标签与包装面板", "en": "Current public label and package panels" }, "detail": { "zh": "ANDA 074823；1、2、5、10 mg，100 粒瓶装；不是 HYTRIN 原品牌。", "en": "ANDA 074823; 1, 2, 5 and 10 mg in 100-capsule bottles; not original-brand HYTRIN." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "图片里的瓶子是 HYTRIN 原研药吗？", "en": "Are the pictured bottles original-brand HYTRIN?" }, "answer": { "zh": "不是。页面将它们明确标为当前通用药比较项，来自 ANDA 074823。HYTRIN 历史身份由 FDA 审评文件证明，但本页没有把当前通用药图片冒充历史原品牌外观。", "en": "No. They are explicitly marked as current generic comparators under ANDA 074823. FDA review supports HYTRIN's historical identity, but the site does not pass current generic images off as historical originator appearance." } }, { "question": { "zh": "停了几天，能按以前的规格直接恢复吗？", "en": "Can I restart the old strength after missing several days?" }, "answer": { "zh": "网页不能给出个人恢复方案。标签特别提示中断数日后恢复可能再次出现明显降压与晕厥风险；请带准确药盒、停药天数、血压、跌倒/头晕情况和完整药单联系开方团队或药师。", "en": "The site cannot provide an individual restart plan. The label specifically warns that restarting after several days can again cause marked blood-pressure lowering and syncope; contact the prescriber or pharmacist with the exact pack, interruption duration, blood pressure, falls/dizziness and full medicine list." } }, { "question": { "zh": "能换成 FLOMAX、RAPAFLO 或 CARDURA 吗？", "en": "Can it be switched to FLOMAX, RAPAFLO or CARDURA?" }, "answer": { "zh": "不能从相似用途或共同 α 阻滞机制作出这种结论。成分、剂型、强度、申请号和说明书不同，不能按 mg 自行一比一换算、轮换或叠加。", "en": "That conclusion cannot be made from a similar use or alpha-blocking mechanism. Ingredients, forms, strengths, applications and labels differ, so do not self-convert, alternate or combine them milligram for milligram." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "dose-unit-literacy", "same-class-is-not-same-medicine", "dosage-forms-are-part-of-medicine-identity" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/hytrin-terazosin/", "en": "https://origindrug.com/en/drugs/hytrin-terazosin/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "rapaflo-silodosin", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-09-02", "status": "published_traceable_archive" }, "names": { "brand": "RAPAFLO", "generic": "西洛多辛胶囊", "aliases": [ "Rapaflo", "silodosin", "西洛多辛", "西洛多辛胶囊", "优利福", "WATSON 151", "WATSON 152", "RAPAFLO", "silodosin capsules", "NDA 022206", "0023-6142-30", "0023-6142-90", "0023-6147-30" ], "marketBrandNames": [ { "name": "RAPAFLO", "market": { "zh": "美国（历史）", "en": "United States (historical)" }, "evidenceStatus": "historical_public_record", "note": { "zh": "NDA 022206；4 mg／8 mg 历史 RLD 当前均列 DISCN，不代表当前品牌供应。", "en": "NDA 022206; the historical 4 mg and 8 mg RLD rows are currently DISCN and do not establish current brand supply." }, "source": { "id": "src_10e511bf83430e3b", "label": "FDA Orange Book 当前数据入口：RAPAFLO／silodosin NDA 022206 两个历史 RLD 规格均列 DISCN", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } } ], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "泌尿健康", "sourceArchiveMarket": "FDA Orange Book 当前把 RAPAFLO 西洛多辛 4 mg 与 8 mg 胶囊、NDA 022206 列为历史 RLD，两个规格均为 DISCN。DailyMed 历史原品牌标签保留 8 mg 的 30／90 粒瓶装与 4 mg 的 30 粒瓶装；最后两个在册品牌 NDC 的营销记录已于 2026-03-31 结束。历史标签、历史包装图、当前通用药、实时库存和其他市场供应不得混写。", "dosageFormClass": "西洛多辛 4 mg／8 mg 口服硬明胶胶囊（历史 RAPAFLO 原品牌）。RAPAFLO、FLOMAX、UROXATRAL、CARDURA／CARDURA XL、HYTRIN、MINIPRESS 及含度他雄胺复方是不同准确产品；共同用途或 α 阻滞机制不建立 mg 换算、开胶囊、叠加、轮换或替换规则。", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "2008-10-08（FDA NDA 022206 批准日期）", "archiveSponsorText": "AbbVie Inc.（FDA 当前 NDA 申请持有人）；历史标签列 Allergan／Kissei" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [ "RAPAFLO", "Rapaflo silodosin", "silodosin capsules", "西洛多辛胶囊" ], "excludedProductCues": [ "RAPAMUNE", "sirolimus", "西罗莫司", "FLOMAX", "tamsulosin", "坦索罗辛", "UROXATRAL", "alfuzosin", "CARDURA", "doxazosin", "HYTRIN", "terazosin" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-rapaflo-silodosin-8mg-30-capsule-bottle-ndc-0023614230", "marketCode": "US", "labelVersion": { "zh": "DailyMed 美国历史原品牌标签（2020-12 修订；该 NDC 营销结束 2026-03-31）", "en": "Historical U.S. originator-brand DailyMed label (revised Dec 2020; marketing for this NDC ended 2026-03-31)" }, "dosageForm": { "zh": "RAPAFLO 西洛多辛口服硬明胶胶囊（历史原品牌）", "en": "RAPAFLO silodosin oral hard-gelatin capsule (historical originator brand)" }, "route": { "zh": "口服（历史品牌产品身份字段）", "en": "oral (historical brand product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 0023-6142-30", "pouchCode": null, "applicationNumber": "NDA 022206", "presentationRole": null, "primaryStrengthBasisCode": "per_capsule", "primaryDisplay": { "zh": "每粒西洛多辛 8 mg；30 粒防儿童开启瓶装；历史 RLD、当前 DISCN", "en": "8 mg silodosin per capsule; 30-capsule child-resistant bottle; historical RLD, currently DISCN" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=rapaflo-07.jpg&archiveid=889761", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "西洛多辛", "en": "silodosin" }, "value": 8, "unit": "mg", "basisCode": "per_capsule", "basisLabel": { "zh": "历史品牌每粒标示量；不是个人粒数、频率或与另一种 α 阻滞剂的换算值", "en": "historical brand amount per capsule; not an individual's capsule count, frequency or conversion to another alpha blocker" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "防儿童开启瓶装", "en": "child-resistant bottle" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-02", "currentLabelDisplayed": false, "ndcDirectoryListed": false, "marketAvailability": "historical_discontinued_rld", "marketingStartDate": null, "marketingEndDate": "2026-03-31", "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 30, "unit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "physicalClues": { "color": { "zh": "白色不透明", "en": "white opaque" }, "shape": { "zh": "硬明胶胶囊；约 19 mm", "en": "hard-gelatin capsule; approximately 19 mm" }, "imprint": "WATSON 152 / 8 mg", "scoreStatus": "not_applicable_capsule_do_not_infer_opening_permission", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_ebc5a497bd5f8b5b", "label": "DailyMed（NLM）：RAPAFLO 西洛多辛 4／8 mg 美国历史原品牌标签、患者安全信息与两个准确包装面板（2020-12 修订；品牌 NDC 营销已结束）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=da0314f6-b1d6-44ee-8b1e-f763dbb8613f", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-rapaflo-silodosin-8mg-90-capsule-bottle-ndc-0023614290", "marketCode": "US", "labelVersion": { "zh": "DailyMed 美国历史原品牌标签（2020-12 修订；该 NDC 营销结束 2022-12-31）", "en": "Historical U.S. originator-brand DailyMed label (revised Dec 2020; marketing for this NDC ended 2022-12-31)" }, "dosageForm": { "zh": "RAPAFLO 西洛多辛口服硬明胶胶囊（历史原品牌）", "en": "RAPAFLO silodosin oral hard-gelatin capsule (historical originator brand)" }, "route": { "zh": "口服（历史品牌产品身份字段）", "en": "oral (historical brand product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 0023-6142-90", "pouchCode": null, "applicationNumber": "NDA 022206", "presentationRole": null, "primaryStrengthBasisCode": "per_capsule", "primaryDisplay": { "zh": "每粒西洛多辛 8 mg；90 粒防儿童开启瓶装；历史 RLD、当前 DISCN", "en": "8 mg silodosin per capsule; 90-capsule child-resistant bottle; historical RLD, currently DISCN" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "西洛多辛", "en": "silodosin" }, "value": 8, "unit": "mg", "basisCode": "per_capsule", "basisLabel": { "zh": "历史品牌每粒标示量；不是个人粒数、频率或与另一种 α 阻滞剂的换算值", "en": "historical brand amount per capsule; not an individual's capsule count, frequency or conversion to another alpha blocker" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "防儿童开启瓶装", "en": "child-resistant bottle" }, "fill": null, "countPerPackage": 90, "countUnit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-02", "currentLabelDisplayed": false, "ndcDirectoryListed": false, "marketAvailability": "historical_discontinued_rld", "marketingStartDate": null, "marketingEndDate": "2022-12-31", "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 90, "unit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "physicalClues": { "color": { "zh": "白色不透明", "en": "white opaque" }, "shape": { "zh": "硬明胶胶囊；约 19 mm", "en": "hard-gelatin capsule; approximately 19 mm" }, "imprint": "WATSON 152 / 8 mg", "scoreStatus": "not_applicable_capsule_do_not_infer_opening_permission", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_ebc5a497bd5f8b5b", "label": "DailyMed（NLM）：RAPAFLO 西洛多辛 4／8 mg 美国历史原品牌标签、患者安全信息与两个准确包装面板（2020-12 修订；品牌 NDC 营销已结束）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=da0314f6-b1d6-44ee-8b1e-f763dbb8613f", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-rapaflo-silodosin-4mg-30-capsule-bottle-ndc-0023614730", "marketCode": "US", "labelVersion": { "zh": "DailyMed 美国历史原品牌标签（2020-12 修订；该 NDC 营销结束 2026-03-31）", "en": "Historical U.S. originator-brand DailyMed label (revised Dec 2020; marketing for this NDC ended 2026-03-31)" }, "dosageForm": { "zh": "RAPAFLO 西洛多辛口服硬明胶胶囊（历史原品牌）", "en": "RAPAFLO silodosin oral hard-gelatin capsule (historical originator brand)" }, "route": { "zh": "口服（历史品牌产品身份字段）", "en": "oral (historical brand product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 0023-6147-30", "pouchCode": null, "applicationNumber": "NDA 022206", "presentationRole": null, "primaryStrengthBasisCode": "per_capsule", "primaryDisplay": { "zh": "每粒西洛多辛 4 mg；30 粒防儿童开启瓶装；历史 RLD、当前 DISCN", "en": "4 mg silodosin per capsule; 30-capsule child-resistant bottle; historical RLD, currently DISCN" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=rapaflo-08.jpg&archiveid=889761", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "西洛多辛", "en": "silodosin" }, "value": 4, "unit": "mg", "basisCode": "per_capsule", "basisLabel": { "zh": "历史品牌每粒标示量；不是个人粒数、频率或与另一种 α 阻滞剂的换算值", "en": "historical brand amount per capsule; not an individual's capsule count, frequency or conversion to another alpha blocker" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "防儿童开启瓶装", "en": "child-resistant bottle" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-02", "currentLabelDisplayed": false, "ndcDirectoryListed": false, "marketAvailability": "historical_discontinued_rld", "marketingStartDate": null, "marketingEndDate": "2026-03-31", "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 30, "unit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "physicalClues": { "color": { "zh": "白色不透明", "en": "white opaque" }, "shape": { "zh": "硬明胶胶囊；约 16 mm", "en": "hard-gelatin capsule; approximately 16 mm" }, "imprint": "WATSON 151 / 4 mg", "scoreStatus": "not_applicable_capsule_do_not_infer_opening_permission", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_ebc5a497bd5f8b5b", "label": "DailyMed（NLM）：RAPAFLO 西洛多辛 4／8 mg 美国历史原品牌标签、患者安全信息与两个准确包装面板（2020-12 修订；品牌 NDC 营销已结束）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=da0314f6-b1d6-44ee-8b1e-f763dbb8613f", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-rapaflo-silodosin-8mg-30-capsule-bottle-ndc-0023614230", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=rapaflo-07.jpg&archiveid=889761", "alt": "RAPAFLO 西洛多辛 8 mg、NDC 0023-6142-30、30 粒瓶装的 DailyMed 历史原品牌标签面板", "archiveMarket": "美国", "labelVersion": "DailyMed 美国历史原品牌标签（2020-12 修订；该 NDC 营销结束 2026-03-31）", "presentation": "8 mg：白色不透明硬明胶胶囊，约 19 mm，绿色刻印 WATSON 152 / 8 mg；NDC 0023-6142-30，30 粒防儿童开启瓶装。另有 4 mg、30 粒的历史准确包装面板。", "notice": "此图只对应美国历史 NDC 0023-6142-30；该 NDC 营销记录已于 2026-03-31 结束。它不代表当前品牌库存、通用药或其他市场包装，也不用于鉴定真伪。", "source": { "id": "src_ebc5a497bd5f8b5b", "label": "DailyMed（NLM）：RAPAFLO 西洛多辛 4／8 mg 美国历史原品牌标签、患者安全信息与两个准确包装面板（2020-12 修订；品牌 NDC 营销已结束）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=da0314f6-b1d6-44ee-8b1e-f763dbb8613f", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "RAPAFLO 说明书放大阅读：分清每粒 4／8 mg、整瓶粒数与历史品牌状态", "en": "RAPAFLO enlarged label: separate 4/8 mg per capsule, bottle count and historical-brand status" }, "summary": { "zh": "4 mg 或 8 mg 是每粒西洛多辛含量；30／90 Capsules 是历史品牌整瓶粒数。FDA 当前把两个品牌规格列为 DISCN；标签内容可用于安全阅读，但不能证明当前品牌有货，也不能据此计算个人粒数。", "en": "Four or eight milligrams is the silodosin amount per capsule; 30/90 Capsules is the historical-brand bottle count. FDA currently lists both brand strengths as DISCN. The label remains useful for safety reading but does not establish current brand stock or calculate an individual's capsule count." }, "checks": [ { "zh": "标签提示开始使用时可能出现站立性低血压、头晕或晕厥。老人、低血压、有跌倒史或同时使用降压药者，应优先把血压情况、完整药单与准确药盒交给医生或药师核对；不要自行错开或停掉一盒。", "en": "The label warns that postural hypotension, dizziness or syncope can occur when starting treatment. Older adults, people with low blood pressure or falls, and those using antihypertensives should prioritise review of blood pressure, the complete medicine list and exact packs with a clinician or pharmacist; do not self-separate or stop a pack." }, { "zh": "肾功能会影响暴露；历史标签把严重肾功能损害列为禁忌，并为中度肾功能损害列出不同规格路径。网页不根据化验值替个人选择 4 mg、8 mg、粒数或时间，必须由负责团队结合当前产品与处方判断。", "en": "Kidney function affects exposure. The historical label contraindicates severe renal impairment and specifies a different strength pathway for moderate impairment. The site does not select 4 mg, 8 mg, capsule count or timing from a laboratory value; the responsible team must assess the current product and prescription." }, { "zh": "强 CYP3A4 抑制剂（标签举例包括酮康唑、伊曲康唑、克拉霉素、利托那韦）属于禁忌联用；强 P-gp 抑制剂如环孢素不建议同用。维拉帕米、红霉素等中度 CYP3A4 抑制剂也需要谨慎核对。不要自行错开时间、减半或临时停药。", "en": "Strong CYP3A4 inhibitors (including ketoconazole, itraconazole, clarithromycin and ritonavir in the label) are contraindicated, and strong P-gp inhibitors such as ciclosporin are not recommended. Moderate CYP3A4 inhibitors such as verapamil or erythromycin also require careful review. Do not self-space, halve or temporarily stop medicines." }, { "zh": "标签说明不应与其他 α 阻滞剂联用，并提示 PDE-5 抑制剂及其他降压药可能增加站立性反应。相似用途或共同机制不等于可以按 mg 自行换算、叠加、轮换或替换。", "en": "The label says not to combine with other alpha blockers and notes that PDE-5 inhibitors and antihypertensives may increase orthostatic effects. Similar use or mechanism does not permit self-conversion, combination, alternation or substitution by milligrams." }, { "zh": "白内障或其他眼科手术前，即使已经停用，也应主动告诉眼科团队曾使用 RAPAFLO／其他 α1 阻滞剂。标签并不支持患者为手术自行停药。", "en": "Before cataract or another eye procedure, tell the eye team about current or previous RAPAFLO/other alpha-1 blocker use, even after stopping. The label does not support self-stopping for surgery." }, { "zh": "出现晕厥、跌倒受伤、持续疼痛勃起或其他急性严重不适时，应优先联系当地紧急医疗服务；不要等待网页判断或用另一种药自行抵消。", "en": "For fainting, a fall with injury, a persistent painful erection or another acute severe problem, prioritise local emergency medical services; do not wait for a webpage decision or self-counteract with another medicine." } ], "source": { "id": "src_ebc5a497bd5f8b5b", "label": "DailyMed（NLM）：RAPAFLO 西洛多辛 4／8 mg 美国历史原品牌标签、患者安全信息与两个准确包装面板（2020-12 修订；品牌 NDC 营销已结束）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=da0314f6-b1d6-44ee-8b1e-f763dbb8613f", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "西洛多辛怎样起作用：选择性阻断下尿路突触后 α1 肾上腺素能受体", "en": "How silodosin works: selective blockade of post-synaptic alpha-1 adrenoceptors in the lower urinary tract" }, "summary": { "zh": "历史标签说明，西洛多辛阻断前列腺、膀胱底/膀胱颈、前列腺包膜与前列腺尿道的突触后 α1 受体，使这些组织的平滑肌松弛，从而改善尿流并减轻良性前列腺增生相关症状；体外研究显示其对 α1A 亚型具有高亲和力。机制不能诊断病因、排除前列腺癌或决定个人用药。", "en": "The historical label explains that silodosin blocks post-synaptic alpha-1 receptors in the prostate, bladder base/neck, prostatic capsule and prostatic urethra, relaxing smooth muscle in these tissues to improve urine flow and reduce BPH-related symptoms. In-vitro work showed high affinity for the alpha-1A subtype. Mechanism cannot diagnose the cause, exclude prostate cancer or determine individual treatment." }, "checks": [ { "zh": "RAPAFLO、RAPAMUNE 与名称相似却是完全不同的药：RAPAFLO 是西洛多辛，RAPAMUNE 是西罗莫司。拍照或文字只出现 RAP 开头时必须继续核对完整商品名、通用名、规格和包装代码，不能自动命中。", "en": "RAPAFLO and RAPAMUNE have similar names but are entirely different medicines: RAPAFLO is silodosin and RAPAMUNE is sirolimus. A photo or text showing only a RAP prefix requires the full brand, generic, strength and package code; it must not auto-match." }, { "zh": "RAPAFLO、FLOMAX、UROXATRAL、CARDURA／CARDURA XL、HYTRIN 与 MINIPRESS 不是同一种药；共同 α 阻滞机制不建立 mg 换算、交替、叠加或替换规则。", "en": "RAPAFLO, FLOMAX, UROXATRAL, CARDURA/CARDURA XL, HYTRIN and MINIPRESS are not one medicine. A related alpha-blocking mechanism creates no milligram conversion, alternation, combination or substitution rule." }, { "zh": "“改善尿流”不是自行诊断良性前列腺增生的依据。排尿困难、尿潴留、血尿、发热、疼痛或症状变化需要及时专业评估；不要只按年龄或他人经验开始或更换药物。", "en": "“Improves urine flow” does not support self-diagnosis of benign prostatic hyperplasia. Difficulty urinating, retention, blood in urine, fever, pain or changing symptoms require timely professional assessment; do not start or switch from age or another person's experience." } ], "source": { "id": "src_ebc5a497bd5f8b5b", "label": "DailyMed（NLM）：RAPAFLO 西洛多辛 4／8 mg 美国历史原品牌标签、患者安全信息与两个准确包装面板（2020-12 修订；品牌 NDC 营销已结束）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=da0314f6-b1d6-44ee-8b1e-f763dbb8613f", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "RAPAFLO", "generic": "西洛多辛胶囊", "dosageFormClass": "西洛多辛 4 mg／8 mg 口服硬明胶胶囊（历史 RAPAFLO 原品牌）。RAPAFLO、FLOMAX、UROXATRAL、CARDURA／CARDURA XL、HYTRIN、MINIPRESS 及含度他雄胺复方是不同准确产品；共同用途或 α 阻滞机制不建立 mg 换算、开胶囊、叠加、轮换或替换规则。" }, "labelSource": { "id": "src_ebc5a497bd5f8b5b", "label": "DailyMed（NLM）：RAPAFLO 西洛多辛 4／8 mg 美国历史原品牌标签、患者安全信息与两个准确包装面板（2020-12 修订；品牌 NDC 营销已结束）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=da0314f6-b1d6-44ee-8b1e-f763dbb8613f", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, "productRoutes": [ { "source": { "id": "src_ebc5a497bd5f8b5b", "label": "DailyMed（NLM）：RAPAFLO 西洛多辛 4／8 mg 美国历史原品牌标签、患者安全信息与两个准确包装面板（2020-12 修订；品牌 NDC 营销已结束）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=da0314f6-b1d6-44ee-8b1e-f763dbb8613f", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-09-02", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_5271f325803f94d1", "label": "DailyMed（NLM）：RAPAFLO 美国历史电子说明书 PDF（可放大阅读；不代表当前品牌供应）", "url": "https://dailymed.nlm.nih.gov/dailymed/downloadpdffile.cfm?setId=da0314f6-b1d6-44ee-8b1e-f763dbb8613f", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-09-02", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_10e511bf83430e3b", "label": "FDA Orange Book 当前数据入口：RAPAFLO／silodosin NDA 022206 两个历史 RLD 规格均列 DISCN", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-08-29", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-09-02", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "RAPAFLO 是西洛多辛 4 mg／8 mg 胶囊的美国历史原品牌档案，当前 FDA 条目均为 DISCN。4 mg 或 8 mg 是每粒含量，30／90 Capsules 是整瓶粒数，不是个人每天粒数。老人或同时使用多种药物者尤其要核对肾功能、站立性低血压/晕厥/跌倒、其他 α 阻滞剂、降压药、PDE-5 抑制剂、强 CYP3A4/P-gp 抑制剂及白内障手术信息；网页不替个人决定规格、粒数、时间或换药。", "history": "FDA 于 2008-10-08 批准 RAPAFLO NDA 022206 的 4 mg 与 8 mg 胶囊。历史标签列产品由 Allergan 分销、Kissei 授权，并保留三个品牌瓶装身份；90 粒 8 mg 包装营销记录于 2022-12-31 结束，30 粒 4 mg 与 8 mg 包装于 2026-03-31 结束。FDA 当前 Orange Book 将两个规格均列为 DISCN，因此所有包装图只能作为历史核对资料。", "sourceDocuments": [ { "id": "src_ebc5a497bd5f8b5b", "label": "DailyMed（NLM）：RAPAFLO 西洛多辛 4／8 mg 美国历史原品牌标签、患者安全信息与两个准确包装面板（2020-12 修订；品牌 NDC 营销已结束）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=da0314f6-b1d6-44ee-8b1e-f763dbb8613f", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, { "id": "src_5271f325803f94d1", "label": "DailyMed（NLM）：RAPAFLO 美国历史电子说明书 PDF（可放大阅读；不代表当前品牌供应）", "url": "https://dailymed.nlm.nih.gov/dailymed/downloadpdffile.cfm?setId=da0314f6-b1d6-44ee-8b1e-f763dbb8613f", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, { "id": "src_f80d2de2f47f6b1e", "label": "FDA：RAPAFLO（silodosin）胶囊 NDA 022206 原始批准函（4 mg／8 mg；2008-10-08）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022206s000_Approv.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_regulatory_document", "documentKind": "regulatory_approval_letter", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, { "id": "src_10e511bf83430e3b", "label": "FDA Orange Book 当前数据入口：RAPAFLO／silodosin NDA 022206 两个历史 RLD 规格均列 DISCN", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } ], "applicationNumber": "NDA 022206", "approvalTimeline": [ { "date": "2008-10-08", "title": { "zh": "FDA 批准 RAPAFLO", "en": "FDA approved RAPAFLO" }, "detail": { "zh": "原始批准函确认 4 mg 与 8 mg 西洛多辛胶囊及良性前列腺增生相关标签用途。", "en": "The original approval letter confirms 4 mg and 8 mg silodosin capsules and the BPH-related labelled use." }, "source": { "id": "src_f80d2de2f47f6b1e", "label": "FDA：RAPAFLO（silodosin）胶囊 NDA 022206 原始批准函（4 mg／8 mg；2008-10-08）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022206s000_Approv.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_regulatory_document", "documentKind": "regulatory_approval_letter", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" } }, { "date": "2022-12-31", "title": { "zh": "8 mg、90 粒历史包装营销记录结束", "en": "Marketing record ended for the historical 8 mg, 90-capsule pack" }, "detail": { "zh": "NDC 0023-6142-90 此后仅作历史产品身份核对。", "en": "NDC 0023-6142-90 is used only as a historical product identity after this date." }, "source": { "id": "src_ebc5a497bd5f8b5b", "label": "DailyMed（NLM）：RAPAFLO 西洛多辛 4／8 mg 美国历史原品牌标签、患者安全信息与两个准确包装面板（2020-12 修订；品牌 NDC 营销已结束）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=da0314f6-b1d6-44ee-8b1e-f763dbb8613f", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" } }, { "date": "2026-03-31", "title": { "zh": "最后两个在册原品牌 NDC 营销记录结束", "en": "Marketing records ended for the last two listed originator-brand NDCs" }, "detail": { "zh": "NDC 0023-6142-30 与 0023-6147-30 的包装图此后只作历史核对；当前 Orange Book 两规格均为 DISCN。", "en": "Package panels for NDC 0023-6142-30 and 0023-6147-30 are historical references after this date; both strengths are currently DISCN in the Orange Book." }, "source": { "id": "src_10e511bf83430e3b", "label": "FDA Orange Book 当前数据入口：RAPAFLO／silodosin NDA 022206 两个历史 RLD 规格均列 DISCN", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "历史 RLD，4 mg／8 mg 当前均为 DISCN", "en": "Historical RLD; both 4 mg and 8 mg currently DISCN" }, "detail": { "zh": "原品牌包装图与电子说明书保留为历史资料，不证明当前品牌有货。", "en": "Originator-brand package panels and the electronic label are retained as historical material and do not establish current brand stock." } }, { "market": { "zh": "中国大陆及其他市场", "en": "Mainland China and other markets" }, "status": { "zh": "现行监管记录待逐市场建立", "en": "Current regulatory records require market-by-market review" }, "detail": { "zh": "“优利福”等名称必须与当地药监记录、现行说明书和手中药盒逐项核对；不从美国历史品牌推定当地批准或供应。", "en": "Names such as 优利福 require item-by-item checking against the local regulator, current leaflet and pack in hand; U.S. historical-brand status does not establish local approval or supply." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "4 mg 和 8 mg 是每天吃几粒吗？", "en": "Do 4 mg and 8 mg tell me how many capsules to take each day?" }, "answer": { "zh": "不是。它们是每粒西洛多辛的历史品牌标示量；30／90 是整瓶粒数。个人规格、粒数、时间与适用性必须结合当前实际产品、处方、肾功能和完整药单由负责团队判断，网页不代算。", "en": "No. They are historical-brand amounts of silodosin per capsule; 30/90 is the bottle count. The responsible team must assess the current exact product, prescription, kidney function and full medicine list to determine strength, capsule count, timing and suitability; the site does not calculate them." } }, { "question": { "zh": "胶囊能打开、倒一半或和食物混合吗？", "en": "Can the capsule be opened, half emptied or mixed with food?" }, "answer": { "zh": "不要从“胶囊”外形自行推断。历史标签包含特定吞咽困难说明，但不能跨厂家、跨市场或脱离处方套用，更不允许目测倒一半来减量。请让药师按手中准确产品的现行说明书核对。", "en": "Do not infer this from the capsule shape. The historical label contains a specific swallowing-difficulty route, but it cannot be transferred across manufacturers or markets or used outside the prescription, and it never permits visually emptying half for dose reduction. Ask a pharmacist to check the current label for the exact product in hand." } }, { "question": { "zh": "能换成 FLOMAX、UROXATRAL 或 CARDURA 吗？", "en": "Can it be switched to FLOMAX, UROXATRAL or CARDURA?" }, "answer": { "zh": "不能从相似用途或共同 α 阻滞机制这样判断。它们的成分、剂型、规格、NDA 与说明书不同，不能按 mg 自行一比一换算、叠加或轮换。", "en": "That conclusion cannot be drawn from a similar use or related alpha-blocking mechanism. Their ingredients, dosage forms, strengths, NDAs and labels differ; do not self-convert, combine or alternate them milligram for milligram." } }, { "question": { "zh": "包装图还能用于判断现在买到的是原品牌吗？", "en": "Can the package panel identify an originator-brand pack available now?" }, "answer": { "zh": "不能。本页两张图来自历史 DailyMed 原品牌标签，相关 NDC 营销记录已结束，FDA 当前把 4 mg／8 mg RAPAFLO 均列为 DISCN。当前药盒必须按完整文字、厂家、NDC/批准信息和目标市场官方记录另行核对。", "en": "No. The two panels come from a historical DailyMed originator-brand label, the related NDC marketing records have ended, and FDA currently lists both RAPAFLO strengths as DISCN. A current pack requires separate review of all text, manufacturer, NDC or approval information and the target market's official record." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "dose-unit-literacy", "same-class-is-not-same-medicine", "dosage-forms-are-part-of-medicine-identity" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/rapaflo-silodosin/", "en": "https://origindrug.com/en/drugs/rapaflo-silodosin/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "uroxatral-alfuzosin", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-09-02", "status": "published_traceable_archive" }, "names": { "brand": "UROXATRAL", "generic": "盐酸阿夫唑嗪缓释片", "aliases": [ "Uroxatral", "alfuzosin", "alfuzosin hydrochloride", "阿夫唑嗪", "盐酸阿夫唑嗪", "盐酸阿夫唑嗪缓释片", "X10", "UROXATRAL", "alfuzosin hydrochloride extended-release tablets", "NDA 021287", "59212-200-30", "59212-200-10" ], "marketBrandNames": [ { "name": "UROXATRAL", "market": { "zh": "美国", "en": "United States" }, "evidenceStatus": "current_regulatory_record", "note": { "zh": "NDA 021287；当前品牌标签列 10 mg 缓释片的 30 片与 100 片瓶装。监管标签不等于实时供应。", "en": "NDA 021287; the current brand label lists 10 mg extended-release tablets in 30- and 100-tablet bottles. A regulatory label is not live supply." }, "source": { "id": "src_1b716f891d349535", "label": "DailyMed（NLM）：UROXATRAL 盐酸阿夫唑嗪 10 mg 缓释片当前美国品牌标签、患者信息与两个包装面板（SPL v9；2024-12-05 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=9fc7f119-f36b-44cf-945d-940160f3afe3", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" } } ], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "泌尿健康", "sourceArchiveMarket": "美国 DailyMed 当前品牌标签列 UROXATRAL 盐酸阿夫唑嗪 10 mg 缓释片的 30 片与 100 片防儿童开启瓶装，均归入 NDA 021287。网页核对的是当前标签与包装身份，不证明当地实时库存、购买资格、个人适用性或其他国家包装。", "dosageFormClass": "盐酸阿夫唑嗪 10 mg 口服缓释片：圆形三层片，一层白色夹在两层黄色之间，刻印 X10。当前标签明确整片吞服，不得压碎、掰开或咀嚼。", "dosageFormClassCode": "oral_modified_release", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "2003（美国初始批准年份）", "archiveSponsorText": "Advanz Pharma (US) Corp.（当前美国品牌标签包装方）" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [ "UROXATRAL", "Uroxatral alfuzosin", "alfuzosin hydrochloride extended-release tablets", "盐酸阿夫唑嗪缓释片" ], "excludedProductCues": [ "FLOMAX", "tamsulosin", "坦索罗辛", "CARDURA", "doxazosin", "多沙唑嗪", "CARDURA XL", "HYTRIN", "terazosin", "MINIPRESS", "prazosin" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-uroxatral-alfuzosin-10mg-30-tablet-bottle-ndc-5921220030", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国品牌标签（SPL v9；2024-12-05 生效）", "en": "Current U.S. DailyMed brand label (SPL v9; effective 5 Dec 2024)" }, "dosageForm": { "zh": "UROXATRAL 盐酸阿夫唑嗪口服缓释片", "en": "UROXATRAL alfuzosin hydrochloride extended-release oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 59212-200-30", "pouchCode": null, "applicationNumber": "NDA 021287", "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片盐酸阿夫唑嗪 10 mg；30 片防儿童开启瓶装", "en": "Alfuzosin hydrochloride 10 mg per tablet; 30-tablet child-resistant bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=uroxatral---30-counts.jpg&setid=9fc7f119-f36b-44cf-945d-940160f3afe3&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "盐酸阿夫唑嗪", "en": "alfuzosin hydrochloride" }, "value": 10, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、频率或与另一种 α 阻滞剂的换算值", "en": "labelled amount per tablet; not an individual's tablet count, frequency or conversion to another alpha blocker" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "防儿童开启瓶装", "en": "child-resistant bottle" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-02", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "current_regulatory_listing_not_live_stock", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 30, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "黄色/白色/黄色三层", "en": "yellow/white/yellow three-layer" }, "shape": { "zh": "圆形三层缓释片；一层白色夹在两层黄色之间", "en": "round three-layer extended-release tablet; one white layer between two yellow layers" }, "imprint": "X10", "scoreStatus": "unscored_do_not_split_crush_or_chew", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_1b716f891d349535", "label": "DailyMed（NLM）：UROXATRAL 盐酸阿夫唑嗪 10 mg 缓释片当前美国品牌标签、患者信息与两个包装面板（SPL v9；2024-12-05 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=9fc7f119-f36b-44cf-945d-940160f3afe3", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-uroxatral-alfuzosin-10mg-100-tablet-bottle-ndc-5921220010", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国品牌标签（SPL v9；2024-12-05 生效）", "en": "Current U.S. DailyMed brand label (SPL v9; effective 5 Dec 2024)" }, "dosageForm": { "zh": "UROXATRAL 盐酸阿夫唑嗪口服缓释片", "en": "UROXATRAL alfuzosin hydrochloride extended-release oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 59212-200-10", "pouchCode": null, "applicationNumber": "NDA 021287", "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片盐酸阿夫唑嗪 10 mg；100 片防儿童开启瓶装", "en": "Alfuzosin hydrochloride 10 mg per tablet; 100-tablet child-resistant bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=uroxatral---100-count-.jpg&setid=9fc7f119-f36b-44cf-945d-940160f3afe3&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "盐酸阿夫唑嗪", "en": "alfuzosin hydrochloride" }, "value": 10, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、频率或与另一种 α 阻滞剂的换算值", "en": "labelled amount per tablet; not an individual's tablet count, frequency or conversion to another alpha blocker" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "防儿童开启瓶装", "en": "child-resistant bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-02", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "current_regulatory_listing_not_live_stock", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "黄色/白色/黄色三层", "en": "yellow/white/yellow three-layer" }, "shape": { "zh": "圆形三层缓释片；一层白色夹在两层黄色之间", "en": "round three-layer extended-release tablet; one white layer between two yellow layers" }, "imprint": "X10", "scoreStatus": "unscored_do_not_split_crush_or_chew", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_1b716f891d349535", "label": "DailyMed（NLM）：UROXATRAL 盐酸阿夫唑嗪 10 mg 缓释片当前美国品牌标签、患者信息与两个包装面板（SPL v9；2024-12-05 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=9fc7f119-f36b-44cf-945d-940160f3afe3", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-uroxatral-alfuzosin-10mg-30-tablet-bottle-ndc-5921220030", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=uroxatral---30-counts.jpg&setid=9fc7f119-f36b-44cf-945d-940160f3afe3&type=img", "alt": "UROXATRAL 盐酸阿夫唑嗪 10 mg、NDC 59212-200-30、30 片瓶装的 DailyMed 官方标签面板", "archiveMarket": "美国", "labelVersion": "DailyMed 当前美国品牌标签（SPL v9；2024-12-05 生效）", "presentation": "10 mg：圆形黄色/白色/黄色三层缓释片，刻印 X10；NDC 59212-200-30，30 片防儿童开启瓶装。另有 NDC 59212-200-10 的 100 片准确包装。", "notice": "此图只对应美国 NDC 59212-200-30 的 10 mg、30 片瓶装，不代表 100 片包装、其他厂家、其他国家包装或实时库存，也不用于鉴定真伪。", "source": { "id": "src_1b716f891d349535", "label": "DailyMed（NLM）：UROXATRAL 盐酸阿夫唑嗪 10 mg 缓释片当前美国品牌标签、患者信息与两个包装面板（SPL v9；2024-12-05 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=9fc7f119-f36b-44cf-945d-940160f3afe3", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "UROXATRAL 说明书放大阅读：10 mg、缓释三层片与整瓶数量要分开看", "en": "UROXATRAL enlarged label: separate 10 mg per tablet, the three-layer extended-release form and bottle count" }, "summary": { "zh": "10 mg 是每片盐酸阿夫唑嗪的标示量；30 或 100 Tablets 是整瓶数量。当前标签明确整片吞服，不得压碎、掰开或咀嚼；网页不根据毫克数计算个人片数。", "en": "10 mg is the labelled alfuzosin hydrochloride amount per tablet; 30 or 100 Tablets is the bottle count. The current label says to swallow the tablet whole and not crush, split or chew it; the site does not calculate an individual's tablet count from milligrams." }, "checks": [ { "zh": "这是一种缓释三层片。不要因吞咽困难、想减量或外观有分层就自行掰开、研碎或咀嚼；请让药师按实际药盒与现行标签核对可行处理或替代剂型。", "en": "This is a three-layer extended-release tablet. Do not split, crush or chew it because of swallowing difficulty, a desired reduction or its layered appearance; have a pharmacist review the actual pack and current label for handling or another suitable form." }, { "zh": "标签提示站立性低血压、头晕与晕厥，并指出与降压药或硝酸酯同用时风险可能增加。老人、有跌倒史或使用多种心血管药者，应优先把完整药单、血压情况与实际包装交给医生或药师核对；不要自行错开或停掉一盒。", "en": "The label warns about postural hypotension, dizziness and syncope and notes potentially increased risk with antihypertensive medicines or nitrates. Older adults, people with falls or several cardiovascular medicines should prioritise full-list, blood-pressure and exact-pack review with a clinician or pharmacist; do not self-separate or stop a pack." }, { "zh": "标签将酮康唑、伊曲康唑、利托那韦等强 CYP3A4 抑制剂列为禁忌联用，并提示西地那非、他达拉非等 PDE5 抑制剂可增加症状性低血压风险。网页不提供自行错开时间、减半或临时停用方案。", "en": "The label contraindicates potent CYP3A4 inhibitors such as ketoconazole, itraconazole and ritonavir and warns that PDE5 inhibitors such as sildenafil or tadalafil can increase symptomatic-hypotension risk. The site provides no self-directed spacing, halving or temporary-stop plan." }, { "zh": "准备白内障手术或其他眼科操作时，应主动告诉眼科团队现在或过去使用过 UROXATRAL/其他 α 阻滞剂。标签并不支持患者为此自行停药。", "en": "Before cataract surgery or another eye procedure, tell the eye team about current or previous UROXATRAL/other alpha-blocker use. The label does not support self-stopping for this reason." }, { "zh": "出现晕厥、跌倒受伤、持续疼痛勃起或其他急性严重不适时，应优先联系当地紧急医疗服务；不要等待网页判断或自行用另一种药抵消。", "en": "For fainting, a fall with injury, a persistent painful erection or another acute severe problem, prioritise local emergency medical services; do not wait for a webpage decision or self-counteract with another medicine." } ], "source": { "id": "src_1b716f891d349535", "label": "DailyMed（NLM）：UROXATRAL 盐酸阿夫唑嗪 10 mg 缓释片当前美国品牌标签、患者信息与两个包装面板（SPL v9；2024-12-05 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=9fc7f119-f36b-44cf-945d-940160f3afe3", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "阿夫唑嗪怎样起作用：阻断下尿路的突触后 α1 肾上腺素能受体", "en": "How alfuzosin works: blocking post-synaptic alpha-1 adrenoceptors in the lower urinary tract" }, "summary": { "zh": "当前标签说明，阿夫唑嗪对前列腺、膀胱底/膀胱颈、前列腺包膜与前列腺尿道的突触后 α1 受体产生拮抗作用，可使膀胱颈和前列腺平滑肌松弛，从而改善尿流和相关症状。它不缩小前列腺，也不因为会影响血压就成为降压药；机制不能决定个人是否适用。", "en": "The current label explains that alfuzosin antagonises post-synaptic alpha-1 receptors in the prostate, bladder base/neck, prostatic capsule and prostatic urethra, allowing bladder-neck and prostate smooth muscle to relax and improving urine flow and related symptoms. It does not shrink the prostate, nor does blood-pressure effect make it an antihypertensive; mechanism cannot determine individual suitability." }, "checks": [ { "zh": "UROXATRAL、FLOMAX、CARDURA、CARDURA XL、HYTRIN 与 MINIPRESS 不是同一种药。共同的 α 阻滞相关机制不建立 mg 换算、交替或叠加规则；当前 UROXATRAL 标签明确不应与其他 α 肾上腺素能拮抗剂合用。", "en": "UROXATRAL, FLOMAX, CARDURA, CARDURA XL, HYTRIN and MINIPRESS are not one medicine. A related alpha-blocking mechanism does not create milligram conversion, alternation or combination rules; the current UROXATRAL label says it should not be used with another alpha-adrenergic antagonist." }, { "zh": "“改善尿流”不是诊断前列腺良性增生或排除前列腺癌的依据。相似症状需要专业检查；不要只按症状、年龄或他人经验自行开始或替换。", "en": "“Improves urine flow” does not diagnose benign prostatic hyperplasia or rule out prostate cancer. Similar symptoms need professional evaluation; do not self-start or substitute from symptoms, age or someone else's experience." }, { "zh": "作用机理不能替代完整药单与个体评估。老人出现站立不稳、晕厥或跌倒，或同用降压药、硝酸酯、PDE5 抑制剂、抗真菌药或抗病毒药时，应及时核对而不是自行停换。", "en": "Mechanism does not replace complete-list and individual review. Unsteadiness on standing, syncope or a fall in an older adult, or co-use with antihypertensives, nitrates, PDE5 inhibitors, antifungals or antivirals requires timely review rather than self-stopping or switching." } ], "source": { "id": "src_1b716f891d349535", "label": "DailyMed（NLM）：UROXATRAL 盐酸阿夫唑嗪 10 mg 缓释片当前美国品牌标签、患者信息与两个包装面板（SPL v9；2024-12-05 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=9fc7f119-f36b-44cf-945d-940160f3afe3", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "UROXATRAL", "generic": "盐酸阿夫唑嗪缓释片", "dosageFormClass": "盐酸阿夫唑嗪 10 mg 口服缓释片：圆形三层片，一层白色夹在两层黄色之间，刻印 X10。当前标签明确整片吞服，不得压碎、掰开或咀嚼。" }, "labelSource": { "id": "src_1b716f891d349535", "label": "DailyMed（NLM）：UROXATRAL 盐酸阿夫唑嗪 10 mg 缓释片当前美国品牌标签、患者信息与两个包装面板（SPL v9；2024-12-05 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=9fc7f119-f36b-44cf-945d-940160f3afe3", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, "productRoutes": [ { "source": { "id": "src_1b716f891d349535", "label": "DailyMed（NLM）：UROXATRAL 盐酸阿夫唑嗪 10 mg 缓释片当前美国品牌标签、患者信息与两个包装面板（SPL v9；2024-12-05 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=9fc7f119-f36b-44cf-945d-940160f3afe3", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-09-02", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_249177a776aa72bb", "label": "DailyMed（NLM）：UROXATRAL 当前美国电子说明书 PDF（可放大阅读）", "url": "https://dailymed.nlm.nih.gov/dailymed/downloadpdffile.cfm?setId=9fc7f119-f36b-44cf-945d-940160f3afe3", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-09-02", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_e7f55520529db924", "label": "FDA：UROXATRAL NDA 021287 美国历史标签档案（2014；仅作批准史补充）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021287s018lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-09-02", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-09-02", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "UROXATRAL 是盐酸阿夫唑嗪 10 mg 缓释片的美国品牌档案，用于帮助读者核对良性前列腺增生相关症状场景中的准确产品。10 mg 是每片含量，30/100 Tablets 是整瓶片数，不是个人每天片数。老人或同时使用多种药物者尤其要核对站立性低血压、晕厥和跌倒、降压药/硝酸酯、PDE5 抑制剂、强 CYP3A4 抑制剂及白内障手术信息；网页不替个人决定时间、片数、联用或换药。", "history": "当前 DailyMed 标签列美国初始批准年份为 2003，SPL v9 于 2024-12-05 生效，展示 Advanz Pharma (US) Corp. 的 30 片与 100 片包装。FDA 2014 标签仅作为历史批准档案补充；现行安全阅读以当前 DailyMed 标签为主。FLOMAX、CARDURA/CARDURA XL 等虽可能涉及相似症状或 α 受体，却是不同成分、剂型、NDA 与说明书，不能按 mg 自行换算、轮换或叠加。", "sourceDocuments": [ { "id": "src_1b716f891d349535", "label": "DailyMed（NLM）：UROXATRAL 盐酸阿夫唑嗪 10 mg 缓释片当前美国品牌标签、患者信息与两个包装面板（SPL v9；2024-12-05 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=9fc7f119-f36b-44cf-945d-940160f3afe3", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, { "id": "src_249177a776aa72bb", "label": "DailyMed（NLM）：UROXATRAL 当前美国电子说明书 PDF（可放大阅读）", "url": "https://dailymed.nlm.nih.gov/dailymed/downloadpdffile.cfm?setId=9fc7f119-f36b-44cf-945d-940160f3afe3", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, { "id": "src_e7f55520529db924", "label": "FDA：UROXATRAL NDA 021287 美国历史标签档案（2014；仅作批准史补充）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021287s018lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" } ], "applicationNumber": "NDA 021287", "approvalTimeline": [ { "date": "2003", "title": { "zh": "UROXATRAL 美国初始批准", "en": "Initial U.S. approval of UROXATRAL" }, "detail": { "zh": "当前 DailyMed 标签列示的初始批准年份。", "en": "Initial approval year stated by the current DailyMed label." }, "source": { "id": "src_1b716f891d349535", "label": "DailyMed（NLM）：UROXATRAL 盐酸阿夫唑嗪 10 mg 缓释片当前美国品牌标签、患者信息与两个包装面板（SPL v9；2024-12-05 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=9fc7f119-f36b-44cf-945d-940160f3afe3", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" } }, { "date": "2014", "title": { "zh": "FDA 历史标签档案", "en": "FDA historical label archive" }, "detail": { "zh": "保留 NDA 021287 的历史标签供批准史追溯，不替代当前标签。", "en": "A historical NDA 021287 label is retained for approval-history traceability and does not replace the current label." }, "source": { "id": "src_e7f55520529db924", "label": "FDA：UROXATRAL NDA 021287 美国历史标签档案（2014；仅作批准史补充）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021287s018lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" } }, { "date": "2024-12-05", "title": { "zh": "当前 DailyMed SPL 生效", "en": "Current DailyMed SPL effective" }, "detail": { "zh": "当前两个 Advanz Pharma 品牌瓶装、患者信息、警示与相互作用可公开阅读。", "en": "The two current Advanz Pharma brand bottles, patient information, warnings and interactions are publicly readable." }, "source": { "id": "src_1b716f891d349535", "label": "DailyMed（NLM）：UROXATRAL 盐酸阿夫唑嗪 10 mg 缓释片当前美国品牌标签、患者信息与两个包装面板（SPL v9；2024-12-05 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=9fc7f119-f36b-44cf-945d-940160f3afe3", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "当前公开品牌标签", "en": "Current public brand label" }, "detail": { "zh": "NDA 021287；10 mg 缓释片，30 片与 100 片瓶装。", "en": "NDA 021287; 10 mg extended-release tablets in 30- and 100-tablet bottles." } }, { "market": { "zh": "美国以外市场", "en": "Markets outside the United States" }, "status": { "zh": "本档案未确认当地商品名、包装或供应", "en": "Local brand, pack and supply are not established by this dossier" }, "detail": { "zh": "当地阿夫唑嗪产品须与本地药监记录、现行说明书和手中药盒逐项核对。", "en": "Local alfuzosin products require item-by-item checking against the local regulator, current leaflet and pack in hand." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "10 mg 是一天吃几片吗？", "en": "Does 10 mg tell me how many tablets to take in a day?" }, "answer": { "zh": "不是。10 mg 是当前准确缓释片中每片的标示量，30/100 是整瓶数量。个人片数、时间与适用性必须以实际处方、当前标签和负责团队为准，网页不会按毫克数代算。", "en": "No. 10 mg is the labelled amount in each exact extended-release tablet, while 30/100 is the bottle count. Individual tablet count, timing and suitability require the actual prescription, current label and responsible team; the site does not calculate them from milligrams." } }, { "question": { "zh": "吞咽困难，可以掰半或研碎吗？", "en": "Can it be halved or crushed if swallowing is difficult?" }, "answer": { "zh": "当前 UROXATRAL 标签明确整片吞服，不得压碎、掰开或咀嚼。请让药师按手中准确产品核对处理选择，不要自行破坏缓释结构。", "en": "The current UROXATRAL label explicitly says to swallow the tablet whole and not crush, split or chew it. Ask a pharmacist to review options for the exact product in hand; do not disrupt the extended-release structure yourself." } }, { "question": { "zh": "与西地那非/他达拉非或降压药一起出现怎么办？", "en": "What if sildenafil/tadalafil or a blood-pressure medicine is on the same list?" }, "answer": { "zh": "不要自行错开、减半或停掉任何一盒。标签提示可能叠加降低血压并引起症状性低血压；请让药师或医生用准确药名、规格、用途、血压和完整药单逐项判断。", "en": "Do not self-separate, halve or stop any pack. The label warns of additive blood-pressure lowering and possible symptomatic hypotension; have a pharmacist or clinician review exact names, strengths, purposes, blood pressure and the full medicine list." } }, { "question": { "zh": "能换成 FLOMAX 或 CARDURA 吗？", "en": "Can it be switched to FLOMAX or CARDURA?" }, "answer": { "zh": "不能从相似用途或共同的 α 阻滞机制作这种结论。它们的成分、剂型、强度、NDA 与说明书不同，不能按 mg 自行一比一转换、叠加或轮换。", "en": "That conclusion cannot be made from a similar use or related alpha-blocking mechanism. Their ingredients, dosage forms, strengths, NDAs and labels differ; do not self-convert, combine or alternate them milligram for milligram." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "dose-unit-literacy", "same-class-is-not-same-medicine", "dosage-forms-are-part-of-medicine-identity" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/uroxatral-alfuzosin/", "en": "https://origindrug.com/en/drugs/uroxatral-alfuzosin/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "mevacor-lovastatin", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-30", "status": "published_traceable_archive" }, "names": { "brand": "MEVACOR", "generic": "洛伐他汀", "aliases": [ "Mevacor", "lovastatin", "洛伐他汀", "美降脂", "洛之达" ], "marketBrandNames": [ { "name": "MEVACOR", "market": { "zh": "美国（历史）", "en": "United States (historical)" }, "evidenceStatus": "historical_public_record", "note": { "zh": "历史原品牌 NDA 019643；10／20／40 mg 当前均列 DISCN，不代表在售。", "en": "Historical originator brand under NDA 019643; all 10/20/40 mg rows are currently DISCN and do not establish supply." }, "source": { "id": "src_ebe929abf66c6eff", "label": "FDA Orange Book：MEVACOR NDA 019643 的 10／20／40 mg 历史品牌条目", "url": "https://www.accessdata.fda.gov/scripts/cder/ob/index.cfm", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" } } ], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "心血管", "sourceArchiveMarket": "美国历史 MEVACOR NDA 019643 的 10／20／40 mg 普通片在 FDA Orange Book 均列为 DISCN，且公开记录注明并非因安全性或有效性原因停产；2025 年 DailyMed 当前 PD-Rx 仿制品标签另列洛伐他汀 40 mg、NDC 43063-548-95、1000 片瓶装和 ANDA 075991。本页严格分开 historical originator brand 与 current generic comparator，不据此证明实时库存、中国大陆或其他市场批准、原研/仿制可替代性或个人适用性。", "dosageFormClass": "MEVACOR 历史产品与当前仿制品比较项均为洛伐他汀普通口服片；ALTOPREV 是另一个 NDA 下的洛伐他汀缓释片，ADVICOR 还含烟酸。普通片、缓释片与复方不能按商品名或总毫克数混同、拼接或替换。", "dosageFormClassCode": "oral_modified_release", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "1987（Merck 历史页记录首个获 FDA 批准的商业化他汀）", "archiveSponsorText": "Merck Research Laboratories（历史 MEVACOR NDA 019643）；PD-Rx Pharmaceuticals（当前仿制品比较项）" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [ "MEVACOR", "Mevacor", "美降脂", "洛伐他汀片" ], "excludedProductCues": [ "ALTOPREV", "lovastatin extended release", "洛伐他汀缓释片", "NDC 021316", "ADVICOR", "lovastatin and niacin" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-mevacor-lovastatin-10mg-historical-nda-019643-002", "marketCode": "US", "labelVersion": { "zh": "FDA Orange Book 历史品牌条目；2012 年品牌标签仅作历史阅读", "en": "Historical FDA Orange Book brand row; the 2012 brand label is retained only for historical reading" }, "dosageForm": { "zh": "MEVACOR 洛伐他汀 10 mg 普通口服片（历史原品牌）", "en": "MEVACOR lovastatin 10 mg conventional oral tablet (historical originator brand)" }, "route": { "zh": "口服（历史品牌产品身份字段）", "en": "oral (historical brand product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDA 019643 / product 002", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片洛伐他汀 10 mg；FDA 当前列为 DISCN", "en": "Lovastatin 10 mg per tablet; currently listed by FDA as DISCN" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "洛伐他汀", "en": "lovastatin" }, "value": 10, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "历史品牌每片标示量；不是个人片数、频率、换药或强度换算", "en": "historical brand amount per tablet; not an individual's tablet count, frequency, switch or intensity conversion" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-30", "currentLabelDisplayed": false, "ndcDirectoryListed": false, "marketAvailability": "historical_discontinued", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": null, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_ebe929abf66c6eff", "label": "FDA Orange Book：MEVACOR NDA 019643 的 10／20／40 mg 历史品牌条目", "url": "https://www.accessdata.fda.gov/scripts/cder/ob/index.cfm", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-mevacor-lovastatin-20mg-historical-nda-019643-003", "marketCode": "US", "labelVersion": { "zh": "FDA Orange Book 历史品牌条目；2012 年品牌标签仅作历史阅读", "en": "Historical FDA Orange Book brand row; the 2012 brand label is retained only for historical reading" }, "dosageForm": { "zh": "MEVACOR 洛伐他汀 20 mg 普通口服片（历史原品牌）", "en": "MEVACOR lovastatin 20 mg conventional oral tablet (historical originator brand)" }, "route": { "zh": "口服（历史品牌产品身份字段）", "en": "oral (historical brand product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDA 019643 / product 003", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片洛伐他汀 20 mg；FDA 当前列为 DISCN", "en": "Lovastatin 20 mg per tablet; currently listed by FDA as DISCN" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "洛伐他汀", "en": "lovastatin" }, "value": 20, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "历史品牌每片标示量；不是个人片数、频率、换药或强度换算", "en": "historical brand amount per tablet; not an individual's tablet count, frequency, switch or intensity conversion" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-30", "currentLabelDisplayed": false, "ndcDirectoryListed": false, "marketAvailability": "historical_discontinued", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": null, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_ebe929abf66c6eff", "label": "FDA Orange Book：MEVACOR NDA 019643 的 10／20／40 mg 历史品牌条目", "url": "https://www.accessdata.fda.gov/scripts/cder/ob/index.cfm", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-mevacor-lovastatin-40mg-historical-nda-019643-004", "marketCode": "US", "labelVersion": { "zh": "FDA Orange Book 历史品牌条目；2012 年品牌标签仅作历史阅读", "en": "Historical FDA Orange Book brand row; the 2012 brand label is retained only for historical reading" }, "dosageForm": { "zh": "MEVACOR 洛伐他汀 40 mg 普通口服片（历史原品牌）", "en": "MEVACOR lovastatin 40 mg conventional oral tablet (historical originator brand)" }, "route": { "zh": "口服（历史品牌产品身份字段）", "en": "oral (historical brand product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDA 019643 / product 004", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片洛伐他汀 40 mg；FDA 当前列为 DISCN", "en": "Lovastatin 40 mg per tablet; currently listed by FDA as DISCN" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "洛伐他汀", "en": "lovastatin" }, "value": 40, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "历史品牌每片标示量；不是个人片数、频率、换药或强度换算", "en": "historical brand amount per tablet; not an individual's tablet count, frequency, switch or intensity conversion" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-30", "currentLabelDisplayed": false, "ndcDirectoryListed": false, "marketAvailability": "historical_discontinued", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": null, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_ebe929abf66c6eff", "label": "FDA Orange Book：MEVACOR NDA 019643 的 10／20／40 mg 历史品牌条目", "url": "https://www.accessdata.fda.gov/scripts/cder/ob/index.cfm", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-pdrx-lovastatin-40mg-1000-tablet-bottle-ndc-43063-548-95-current-anda", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国仿制品标签（2025-02-28 更新；2025-03-05 发布）", "en": "Current U.S. DailyMed generic label (updated 28 Feb 2025; published 5 Mar 2025)" }, "dosageForm": { "zh": "PD-Rx 洛伐他汀 40 mg 普通口服片（当前仿制品比较项）", "en": "PD-Rx lovastatin 40 mg conventional oral tablet (current generic comparator)" }, "route": { "zh": "口服（当前仿制品产品身份字段）", "en": "oral (current generic product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 43063-548-95", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片洛伐他汀 40 mg；1000 片瓶装；ANDA 075991 仿制品比较项", "en": "Lovastatin 40 mg per tablet; 1,000-tablet bottle; ANDA 075991 generic comparator" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=43063548.jpg&setid=eea93a4b-f804-4b9c-aabf-e906f03c1e80", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "洛伐他汀", "en": "lovastatin" }, "value": 40, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "当前标签每片标示量；不是个人片数、频率、疗程或与其他他汀的换算", "en": "current labelled amount per tablet; not an individual's tablet count, frequency, course or conversion to another statin" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 1000, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-30", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 1000, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "白色至类白色", "en": "white to off-white" }, "shape": { "zh": "圆形、无刻痕", "en": "round, unscored" }, "imprint": "CTI 143", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_31be988ae325b56e", "label": "DailyMed（NLM）：PD-Rx 洛伐他汀 40 mg 当前美国仿制品标签（SPL v26，2025-03-05 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=eea93a4b-f804-4b9c-aabf-e906f03c1e80&version=26", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-pdrx-lovastatin-40mg-1000-tablet-bottle-ndc-43063-548-95-current-anda", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=43063548.jpg&setid=eea93a4b-f804-4b9c-aabf-e906f03c1e80", "alt": "PD-Rx 洛伐他汀 40 mg、NDC 43063-548-95、1000 片瓶装当前美国仿制品标签面板", "archiveMarket": "美国", "labelVersion": "DailyMed 当前仿制品 SPL v26（2025-03-05 发布）", "presentation": "PD-Rx 洛伐他汀 40 mg；NDC 43063-548-95；1000 片瓶装；ANDA 075991 比较项", "notice": "此图是当前美国仿制品准确标签面板，不是历史 MEVACOR 原品牌包装。只对应所列 NDC、强度和瓶装，不用于鉴定真伪，也不证明库存、购买资格、个人适用或可与历史 MEVACOR、ALTOPREV、ADVICOR 或其他他汀自行替换。", "source": { "id": "src_31be988ae325b56e", "label": "DailyMed（NLM）：PD-Rx 洛伐他汀 40 mg 当前美国仿制品标签（SPL v26，2025-03-05 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=eea93a4b-f804-4b9c-aabf-e906f03c1e80&version=26", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "MEVACOR／洛伐他汀说明书放大阅读：先核对相互作用、肌肉症状和准确剂型", "en": "MEVACOR / lovastatin label reading: first check interactions, muscle symptoms and exact dosage form" }, "summary": { "zh": "本模块用历史 MEVACOR 标签、Orange Book 与当前仿制品标签帮助识别洛伐他汀普通片及风险线索；不生成个人片数、服用时间、频率、换药、停药或强度换算。", "en": "This module uses the historical MEVACOR label, Orange Book and a current generic label to identify conventional lovastatin tablets and risk cues. It does not generate personal tablet counts, timing, frequency, switching, stopping or intensity conversion." }, "checks": [ { "zh": "克拉霉素、伊曲康唑、酮康唑等强 CYP3A 抑制剂与洛伐他汀存在重要相互作用边界；实际药单还可能包含其他需要核对的药物。不要凭网页自行错开时间、减量、停药或继续，先让开方团队或药师核对全部处方药、非处方药和保健品。", "en": "Clarithromycin, itraconazole, ketoconazole and other strong CYP3A inhibitors create important interaction boundaries with lovastatin. Other medicines may also require review. Do not self-separate times, reduce, stop or continue from this page; have the prescribing team or pharmacist check all prescription, OTC and supplement products." }, { "zh": "无法解释的肌肉痛、压痛、抽筋或无力，尤其伴明显乏力、发热或深色尿，可能需要尽快医疗评估；严重或迅速恶化时使用当地急救服务，不等待网页判定是否为横纹肌溶解。", "en": "Unexplained muscle pain, tenderness, cramps or weakness, especially with marked fatigue, fever or dark urine, may need prompt assessment. Use local emergency services for severe or rapidly worsening signs rather than waiting for a webpage to decide whether rhabdomyolysis is present." }, { "zh": "孕期、可能怀孕、备孕或哺乳期需要及时核对当前标签和临床计划。不要根据历史标签或网页自行继续、停用、隔日服用或换成另一种他汀。", "en": "Pregnancy, possible pregnancy, pregnancy planning or breastfeeding requires prompt review of the current label and clinical plan. Do not self-continue, stop, use alternate days or switch statins from a historical label or webpage." }, { "zh": "MEVACOR 历史 10／20／40 mg 与当前仿制 40 mg 都是普通片产品身份；ALTOPREV 是缓释片，ADVICOR 是含烟酸的复方。剂型、成分、强度、NDA／ANDA、NDC 和目标市场必须一起核对。", "en": "Historical MEVACOR 10/20/40 mg and the current 40 mg generic comparator are conventional-tablet identities. ALTOPREV is extended-release and ADVICOR also contains niacin. Form, ingredients, strength, NDA/ANDA, NDC and target market must be checked together." }, { "zh": "老年人、肝肾功能异常、甲状腺问题、既往肌肉不良反应、同时使用其他降脂药或大量饮酒等情况可能改变专业判断。网页不会从年龄、一次化验或一个药名决定个人选药。", "en": "Older age, liver or kidney dysfunction, thyroid disease, previous muscle reactions, other lipid-lowering medicines or heavy alcohol use may change professional judgement. The site does not select an individual medicine from age, one laboratory result or one name." } ], "source": { "id": "src_31be988ae325b56e", "label": "DailyMed（NLM）：PD-Rx 洛伐他汀 40 mg 当前美国仿制品标签（SPL v26，2025-03-05 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=eea93a4b-f804-4b9c-aabf-e906f03c1e80&version=26", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "洛伐他汀怎样起作用：HMG-CoA 还原酶抑制不是他汀等量表", "en": "How lovastatin works: HMG-CoA reductase inhibition is not a statin equivalence table" }, "summary": { "zh": "洛伐他汀经体内转化后的活性形式抑制 HMG-CoA 还原酶，影响胆固醇合成通路。这个机制解释药物类别，但不能把洛伐他汀、阿托伐他汀、瑞舒伐他汀、普伐他汀、氟伐他汀或辛伐他汀按 mg 直接换算。", "en": "Lovastatin is converted in the body to an active form that inhibits HMG-CoA reductase in the cholesterol-synthesis pathway. This explains the class but does not make lovastatin, atorvastatin, rosuvastatin, pravastatin, fluvastatin or simvastatin directly milligram-convertible." }, "checks": [ { "zh": "同属他汀不表示剂量等量，也不允许一天一种、隔日轮换、叠加或用旧药顶替新处方。需要结合准确产品、完整药单、适应症、化验、肝肾功能和治疗目标。", "en": "A shared statin class does not mean dose equivalence or permit day-by-day use, alternate-day rotation, combination or substitution with leftover medicine. Exact product, full medicine list, indication, laboratory results, liver/kidney function and treatment goal all matter." }, { "zh": "共同机制不能证明原研一定更适合个人，也不能仅凭品牌、价格或外观判断仿制品是否可替代；监管批准、剂型、质量标准与开方计划要分开核对。", "en": "A shared mechanism does not prove that an originator is always more suitable for an individual, nor can brand, price or appearance alone decide generic substitution. Regulatory approval, dosage form, quality standards and prescribing plan require separate checks." }, { "zh": "药物基因信息可能在特定临床问题中有价值，但洛伐他汀或‘他汀’三个字不等于人人需要全基因组筛查。检测与解释应由合格专业人员结合具体药物与病史决定。", "en": "Pharmacogenetic information may matter for a specific clinical question, but lovastatin or the word statin does not mean everyone needs whole-genome screening. Testing and interpretation require a qualified professional using the exact medicine and history." } ], "source": { "id": "src_b86cc783b48ebd3f", "label": "FDA：MEVACOR（lovastatin）NDA 019643 历史标签（2012；明确提示不是最新标签）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019643s085lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "MEVACOR", "generic": "洛伐他汀", "dosageFormClass": "MEVACOR 历史产品与当前仿制品比较项均为洛伐他汀普通口服片；ALTOPREV 是另一个 NDA 下的洛伐他汀缓释片，ADVICOR 还含烟酸。普通片、缓释片与复方不能按商品名或总毫克数混同、拼接或替换。" }, "labelSource": { "id": "src_31be988ae325b56e", "label": "DailyMed（NLM）：PD-Rx 洛伐他汀 40 mg 当前美国仿制品标签（SPL v26，2025-03-05 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=eea93a4b-f804-4b9c-aabf-e906f03c1e80&version=26", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "productRoutes": [ { "source": { "id": "src_31be988ae325b56e", "label": "DailyMed（NLM）：PD-Rx 洛伐他汀 40 mg 当前美国仿制品标签（SPL v26，2025-03-05 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=eea93a4b-f804-4b9c-aabf-e906f03c1e80&version=26", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-30", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_b86cc783b48ebd3f", "label": "FDA：MEVACOR（lovastatin）NDA 019643 历史标签（2012；明确提示不是最新标签）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019643s085lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-08-30", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_ebe929abf66c6eff", "label": "FDA Orange Book：MEVACOR NDA 019643 的 10／20／40 mg 历史品牌条目", "url": "https://www.accessdata.fda.gov/scripts/cder/ob/index.cfm", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-08-30", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-30", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "MEVACOR 是洛伐他汀的美国历史原品牌，20 mg 于 1987 年获批；FDA 当前把 10／20／40 mg 历史品牌条目均列为停产。页面同时展示一个当前美国仿制洛伐他汀 40 mg 的准确包装比较项，但不会把它冒充原品牌。不同他汀、普通片与缓释片不能只按 mg 自行换算；克拉霉素、部分唑类抗真菌药、其他强 CYP3A 抑制剂，以及多种完整药单因素都需要专业核对。", "history": "洛伐他汀从真菌来源化合物研究发展为药物。Merck 记录 1987 年推出洛伐他汀；Orange Book 记载 MEVACOR 20 mg 于 1987-08-31 获批、40 mg 于 1988-12-14 获批、10 mg 于 1991-03-28 获批。三项历史品牌记录目前均为 DISCN，不能当作实时品牌供应证据。", "sourceDocuments": [ { "id": "src_f6fe27de971841ca", "label": "Merck：1987 年推出洛伐他汀——首个获 FDA 批准的商业化他汀历史记录", "url": "https://www.merck.com/company-overview/history/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "first_party_product_history", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, { "id": "src_b86cc783b48ebd3f", "label": "FDA：MEVACOR（lovastatin）NDA 019643 历史标签（2012；明确提示不是最新标签）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019643s085lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, { "id": "src_ebe929abf66c6eff", "label": "FDA Orange Book：MEVACOR NDA 019643 的 10／20／40 mg 历史品牌条目", "url": "https://www.accessdata.fda.gov/scripts/cder/ob/index.cfm", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, { "id": "src_31be988ae325b56e", "label": "DailyMed（NLM）：PD-Rx 洛伐他汀 40 mg 当前美国仿制品标签（SPL v26，2025-03-05 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=eea93a4b-f804-4b9c-aabf-e906f03c1e80&version=26", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" } ], "applicationNumber": "FDA NDA 019643（历史 MEVACOR）／ANDA 075991（当前仿制品比较项）", "approvalTimeline": [ { "date": "1987-08-31", "title": { "zh": "MEVACOR 20 mg 美国获批", "en": "U.S. approval of MEVACOR 20 mg" }, "detail": { "zh": "Orange Book 记录 NDA 019643 product 003；Merck 将 1987 年洛伐他汀写入其首个商业化他汀历史。", "en": "Orange Book records NDA 019643 product 003; Merck places lovastatin in its 1987 first-commercial-statin history." }, "source": { "id": "src_ebe929abf66c6eff", "label": "FDA Orange Book：MEVACOR NDA 019643 的 10／20／40 mg 历史品牌条目", "url": "https://www.accessdata.fda.gov/scripts/cder/ob/index.cfm", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" } }, { "date": "1988-12-14／1991-03-28", "title": { "zh": "40 mg 与 10 mg 历史规格获批", "en": "Historical 40 mg and 10 mg strength approvals" }, "detail": { "zh": "这些日期定位历史品牌规格，不表示今天可购买、适合个人或可以互换。", "en": "These dates identify historical brand strengths and do not establish current purchase availability, individual suitability or interchangeability." }, "source": { "id": "src_ebe929abf66c6eff", "label": "FDA Orange Book：MEVACOR NDA 019643 的 10／20／40 mg 历史品牌条目", "url": "https://www.accessdata.fda.gov/scripts/cder/ob/index.cfm", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" } }, { "date": "2026-08-30", "title": { "zh": "历史品牌与当前仿制品状态复核", "en": "Historical-brand and current-generic status review" }, "detail": { "zh": "MEVACOR 三个规格均为 DISCN；当前 DailyMed 仿制品 40 mg 比较项另行展示，不冒充品牌。", "en": "All three MEVACOR strengths are DISCN; a current DailyMed 40 mg generic comparator is displayed separately and is not presented as the brand." }, "source": { "id": "src_31be988ae325b56e", "label": "DailyMed（NLM）：PD-Rx 洛伐他汀 40 mg 当前美国仿制品标签（SPL v26，2025-03-05 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=eea93a4b-f804-4b9c-aabf-e906f03c1e80&version=26", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "历史原品牌已停产；当前仿制品标签比较项已建立", "en": "Historical originator brand discontinued; current generic label comparator established" }, "detail": { "zh": "DISCN、标签存在和 NDC 记录都不等于实时有货。", "en": "DISCN status, label availability and an NDC record do not establish real-time stock." } }, { "market": { "zh": "中国大陆及其他市场", "en": "Mainland China and other markets" }, "status": { "zh": "现行监管记录待逐市场建立", "en": "Current regulatory records require market-by-market review" }, "detail": { "zh": "不从美国历史品牌或仿制包装推定当地批准、品牌名、供应、原研／仿制关系或合法购药渠道。", "en": "No local approval, brand name, supply, originator/generic relationship or lawful purchasing route is inferred from a U.S. historical brand or generic pack." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "MEVACOR 现在还能买到原品牌吗？", "en": "Is originator-brand MEVACOR currently available?" }, "answer": { "zh": "本页不能这样证明。FDA Orange Book 当前把 10／20／40 mg MEVACOR 条目列为 DISCN；网页展示的是历史原品牌档案和一个当前仿制品标签比较项，不提供库存或购买承诺。", "en": "This page cannot establish that. FDA currently lists the 10/20/40 mg MEVACOR rows as DISCN. The page shows a historical originator archive and one current generic-label comparator, not stock or a purchase promise." } }, { "question": { "zh": "洛伐他汀 40 mg 能直接换成另一种他汀 40 mg 吗？", "en": "Can lovastatin 40 mg be directly switched to 40 mg of another statin?" }, "answer": { "zh": "不能只按数字这样换算。不同他汀的强度、相互作用、剂型、适应症和处方目标不同；不要自行替换、轮换或叠加，应让开方团队或药师核对。", "en": "Not from the number alone. Statin intensity, interactions, dosage form, indication and prescribing goal differ. Do not self-substitute, rotate or combine; ask the prescribing team or pharmacist to review." } }, { "question": { "zh": "正在吃克拉霉素，还能继续洛伐他汀吗？", "en": "Can lovastatin be continued while taking clarithromycin?" }, "answer": { "zh": "这是需要尽快由专业人员核对的重要相互作用场景。网页不会替个人决定继续、暂停、减量或错开时间；请联系开具任一药物的团队或药师，带上全部药盒和药单。出现严重肌肉症状或深色尿时及时就医。", "en": "This is an important interaction scenario requiring prompt professional review. The site will not decide whether an individual should continue, pause, reduce or separate timing. Contact the team prescribing either medicine or a pharmacist with all packs and the complete list. Seek prompt care for severe muscle symptoms or dark urine." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "dosage-forms-are-part-of-medicine-identity", "polypharmacy-safety-guide", "statin-gene-testing-what-labels-can-and-cannot-say" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/mevacor-lovastatin/", "en": "https://origindrug.com/en/drugs/mevacor-lovastatin/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "lescol-xl-fluvastatin", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-30", "status": "published_traceable_archive" }, "names": { "brand": "LESCOL XL", "generic": "氟伐他汀钠", "aliases": [ "Lescol XL", "fluvastatin", "fluvastatin sodium", "氟伐他汀", "氟伐他汀钠", "益脂可" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "心血管", "sourceArchiveMarket": "美国 DailyMed 当前 LESCOL XL 氟伐他汀钠 80 mg 缓释片公开标签（2023-11 修订；NDA 021192）；30 片瓶装与已记录 2021-02-28 营销终止日期的 100 片瓶装须分开阅读", "dosageFormClass": "氟伐他汀钠 80 mg 口服缓释片：每片相当于氟伐他汀 80 mg；本档案不并入 LESCOL 20 mg／40 mg 普通胶囊", "dosageFormClassCode": "oral_modified_release", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "1993（当前美国公开标签所列 Initial U.S. Approval）", "archiveSponsorText": "Novartis Pharmaceuticals Corporation／Sandoz Inc.（当前美国公开标签所列标签与生产资料主体）" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [ "LESCOL XL", "LESCOL XL 80 mg", "LESCOL XL extended-release tablet" ], "excludedProductCues": [ "LESCOL capsule 20 mg", "LESCOL capsule 40 mg", "fluvastatin 20 mg capsule", "fluvastatin 40 mg capsule", "氟伐他汀 20 mg 胶囊", "氟伐他汀 40 mg 胶囊" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-lescol-xl-fluvastatin-er-tablet-80mg-30-bottle-ndc-0078035415-current-label", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（2023-11 修订）", "en": "Current U.S. DailyMed public label (revised Nov 2023)" }, "dosageForm": { "zh": "LESCOL XL 氟伐他汀钠 80 mg 口服缓释片", "en": "LESCOL XL fluvastatin sodium 80 mg extended-release oral tablet" }, "route": { "zh": "口服（准确产品身份字段）", "en": "oral (exact product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 0078-0354-15", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片相当于氟伐他汀 80 mg；30 片瓶装", "en": "Equivalent to fluvastatin 80 mg per tablet; 30-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=lescol-01.jpg&archiveid=898359", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "氟伐他汀（由氟伐他汀钠提供）", "en": "fluvastatin (provided as fluvastatin sodium)" }, "value": 80, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、频率、换药或他汀换算指令", "en": "labelled amount per tablet; not an individual's tablet count, frequency, switching or statin-conversion instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-30", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 30, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "黄色", "en": "yellow" }, "shape": { "zh": "圆形、轻微双凸、斜边薄膜衣片", "en": "round, slightly biconvex, bevelled film-coated tablet" }, "imprint": "LESCOL XL / 80", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_cbe7ec1a9ebc15ae", "label": "DailyMed（NLM）：LESCOL XL 氟伐他汀钠 80 mg 缓释片当前美国公开标签（2023-11 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8a1823e7-26fb-4858-bac7-9e152e5ea16a", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-lescol-xl-fluvastatin-er-tablet-80mg-100-bottle-ndc-0078035405-marketing-ended-2021", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（2023-11 修订）", "en": "Current U.S. DailyMed public label (revised Nov 2023)" }, "dosageForm": { "zh": "LESCOL XL 氟伐他汀钠 80 mg 口服缓释片", "en": "LESCOL XL fluvastatin sodium 80 mg extended-release oral tablet" }, "route": { "zh": "口服（准确产品身份字段）", "en": "oral (exact product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 0078-0354-05", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片相当于氟伐他汀 80 mg；100 片瓶装", "en": "Equivalent to fluvastatin 80 mg per tablet; 100-tablet bottle" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "氟伐他汀（由氟伐他汀钠提供）", "en": "fluvastatin (provided as fluvastatin sodium)" }, "value": 80, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、频率、换药或他汀换算指令", "en": "labelled amount per tablet; not an individual's tablet count, frequency, switching or statin-conversion instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-30", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "historical_marketing_ended", "marketingStartDate": null, "marketingEndDate": "2021-02-28", "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "黄色", "en": "yellow" }, "shape": { "zh": "圆形、轻微双凸、斜边薄膜衣片", "en": "round, slightly biconvex, bevelled film-coated tablet" }, "imprint": "LESCOL XL / 80", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_cbe7ec1a9ebc15ae", "label": "DailyMed（NLM）：LESCOL XL 氟伐他汀钠 80 mg 缓释片当前美国公开标签（2023-11 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8a1823e7-26fb-4858-bac7-9e152e5ea16a", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-lescol-xl-fluvastatin-er-tablet-80mg-30-bottle-ndc-0078035415-current-label", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=lescol-01.jpg&archiveid=898359", "alt": "LESCOL XL 氟伐他汀钠 80 mg、NDC 0078-0354-15、30 片瓶装在美国 DailyMed 当前公开标签中的官方包装面板", "archiveMarket": "美国", "labelVersion": "DailyMed 当前美国公开标签（2023-11 修订）", "presentation": "LESCOL XL 氟伐他汀钠缓释片：每片相当于氟伐他汀 80 mg，NDC 0078-0354-15，30 片瓶装。", "notice": "此图只对应当前美国公开标签中的 LESCOL XL 80 mg、NDC 0078-0354-15 与 30 片瓶装。它帮助核对商品名、通用名、缓释剂型、每片标示量、NDC 和包装；不用于鉴定真伪，也不代表 100 片瓶装、普通 LESCOL 胶囊、其他氟伐他汀、其他他汀、其他市场、当前有货、原研身份、可替代性或任何人的片数和换药方案。", "source": { "id": "src_cbe7ec1a9ebc15ae", "label": "DailyMed（NLM）：LESCOL XL 氟伐他汀钠 80 mg 缓释片当前美国公开标签（2023-11 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8a1823e7-26fb-4858-bac7-9e152e5ea16a", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "LESCOL XL 说明书放大阅读：80 mg 缓释片不是 20／40 mg 普通胶囊的网页换算项", "en": "LESCOL XL label reading: the 80 mg extended-release tablet is not a web conversion for 20/40 mg conventional capsules" }, "summary": { "zh": "当前美国标签只把 LESCOL XL 建立为每片相当于氟伐他汀 80 mg 的缓释片，并要求整片吞服，不得掰开、压碎或咀嚼。本页不把缓释片与 LESCOL 20 mg／40 mg 普通胶囊、其他规格或其他他汀按数字换算。", "en": "The current U.S. label establishes LESCOL XL as an extended-release tablet equivalent to fluvastatin 80 mg per tablet and says to swallow it whole without breaking, crushing or chewing. This page does not numerically convert it to LESCOL 20 mg/40 mg conventional capsules, another strength or another statin." }, "checks": [ { "zh": "先同时核对 LESCOL XL、氟伐他汀钠、缓释片、每片 80 mg、实际 NDC 和瓶装数量。mg 是准确缓释片每片的标示量，不是个人应吃几片，也不是把两粒 40 mg 普通胶囊自动当作一片 80 mg 缓释片的许可。", "en": "Check LESCOL XL, fluvastatin sodium, extended-release tablet, 80 mg per tablet, the actual NDC and bottle count together. The mg figure is the labelled amount in the exact extended-release tablet, not an individual's tablet count or permission to treat two 40 mg conventional capsules as one 80 mg extended-release tablet." }, { "zh": "LESCOL XL 缓释片须整片吞服，不得掰开、压碎或咀嚼。片剂无刻痕；外观和官方包装面板只用于辅助核对，不能证明真伪或允许自行改变缓释结构。", "en": "Swallow LESCOL XL extended-release tablets whole; do not break, crush or chew them. The tablet is unscored. Appearance and the official package panel support identity checking only and cannot authenticate a pack or permit self-alteration of the release design." }, { "zh": "LESCOL 普通胶囊 20 mg／40 mg 与 LESCOL XL 80 mg 缓释片不是只看总毫克数就相同的产品。剂型、释放结构、目标市场现行标签和处方必须一起核对，网页不安排互换、轮换或补服。", "en": "LESCOL conventional 20 mg/40 mg capsules and the LESCOL XL 80 mg extended-release tablet are not the same product merely because totals can be added. Form, release design, current target-market label and prescription must be reviewed together; the site does not arrange substitution, rotation or make-up use." }, { "zh": "无法解释的肌肉痛、压痛或无力，尤其伴不适、发热或深色尿，可能需要尽快医疗评估；当前标签列有肌病和横纹肌溶解警示。肝功能问题、甲状腺功能减退、肾功能问题及环孢素、吉非贝齐等完整药单也应交给药师或开方团队核对。", "en": "Unexplained muscle pain, tenderness or weakness, especially with malaise, fever or dark urine, may need prompt medical assessment; the current label includes myopathy and rhabdomyolysis warnings. Liver concerns, hypothyroidism, kidney concerns and a complete medicine list including ciclosporin or gemfibrozil also need pharmacist or prescriber review." }, { "zh": "怀孕、可能怀孕或哺乳时，不要凭网页自行继续、停用、隔天吃或换成另一种他汀；尽快联系开方团队或药师，按准确市场和现行说明书处理。", "en": "When pregnant, possibly pregnant or breastfeeding, do not use this page to self-continue, stop, alternate days or switch to another statin; contact the prescribing team or pharmacist promptly using the exact market and current label." } ], "source": { "id": "src_cbe7ec1a9ebc15ae", "label": "DailyMed（NLM）：LESCOL XL 氟伐他汀钠 80 mg 缓释片当前美国公开标签（2023-11 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8a1823e7-26fb-4858-bac7-9e152e5ea16a", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "氟伐他汀怎样起作用：HMG-CoA 还原酶抑制机制不是他汀等量换算表", "en": "How fluvastatin works: HMG-CoA reductase inhibition is not a statin equivalence table" }, "summary": { "zh": "当前标签将氟伐他汀描述为 HMG-CoA 还原酶抑制剂，通过抑制胆固醇合成相关路径发挥作用。共同机制只能帮助理解药物类别，不能决定个人适合哪一种他汀、能否隔天轮换、是否同服、需要多少强度或是否需要全基因筛查。", "en": "The current label describes fluvastatin as an HMG-CoA reductase inhibitor acting on a cholesterol-synthesis pathway. A shared mechanism helps explain the drug class but cannot decide which statin fits an individual, whether alternate-day rotation or co-use is suitable, what intensity is needed or whether whole-genome screening is required." }, "checks": [ { "zh": "LESCOL XL、MEVALOTIN、LIPITOR、CRESTOR、ZOCOR 和 LIVALO 都不能只凭他汀类别或毫克数自行等量换算、隔天轮换或叠加。", "en": "LESCOL XL, MEVALOTIN, LIPITOR, CRESTOR, ZOCOR and LIVALO cannot be self-converted, alternated by day or combined from statin class or milligram numbers alone." }, { "zh": "年龄、肌肉症状、肝肾功能、甲状腺状况、相互作用、适应症和治疗目标都会影响专业判断。网页不会从单次化验、症状或药名替个人挑选他汀。", "en": "Age, muscle symptoms, liver/kidney function, thyroid status, interactions, indication and treatment goals may affect professional judgement. The site does not select a statin for an individual from one laboratory result, symptom or medicine name." }, { "zh": "基因检测可能在特定问题中参与解释，但‘他汀’或某个副作用不等于人人需要全基因组筛查；是否检测及怎样解释须由合格专业人员结合实际产品和临床背景决定。", "en": "Genetic testing can inform selected questions, but a statin or one adverse effect does not mean everyone needs whole-genome screening. A qualified professional must decide whether to test and how to interpret results using the actual product and clinical context." } ], "source": { "id": "src_cbe7ec1a9ebc15ae", "label": "DailyMed（NLM）：LESCOL XL 氟伐他汀钠 80 mg 缓释片当前美国公开标签（2023-11 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8a1823e7-26fb-4858-bac7-9e152e5ea16a", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "LESCOL XL", "generic": "氟伐他汀钠", "dosageFormClass": "氟伐他汀钠 80 mg 口服缓释片：每片相当于氟伐他汀 80 mg；本档案不并入 LESCOL 20 mg／40 mg 普通胶囊" }, "labelSource": { "id": "src_cbe7ec1a9ebc15ae", "label": "DailyMed（NLM）：LESCOL XL 氟伐他汀钠 80 mg 缓释片当前美国公开标签（2023-11 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8a1823e7-26fb-4858-bac7-9e152e5ea16a", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "productRoutes": [ { "source": { "id": "src_cbe7ec1a9ebc15ae", "label": "DailyMed（NLM）：LESCOL XL 氟伐他汀钠 80 mg 缓释片当前美国公开标签（2023-11 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8a1823e7-26fb-4858-bac7-9e152e5ea16a", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-30", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-30", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "LESCOL XL 是氟伐他汀钠 80 mg 口服缓释片的美国品牌档案。当前 DailyMed 标签展示 30 片瓶装的准确 NDC 和官方包装面板，并保留 100 片瓶装的历史营销终止日期。本页帮助普通读者分清每片 80 mg、缓释结构、准确包装和普通 LESCOL 胶囊的产品边界；不按毫克数计算个人片数，也不把氟伐他汀与普伐他汀、阿托伐他汀、瑞舒伐他汀等自行换算、隔天轮换或叠加。", "history": "当前标签列示氟伐他汀 Initial U.S. Approval 为 1993；FDA 2020 年 NDA 021192／S-031 补充批准函记录了 LESCOL XL 标签更新。DailyMed 当前页面列出 80 mg 缓释片的 30 片瓶装和 100 片瓶装，其中 100 片 NDC 的营销终止日期为 2021-02-28。文件日期和状态用于产品身份核对，不代表实时库存。", "sourceDocuments": [ { "id": "src_cbe7ec1a9ebc15ae", "label": "DailyMed（NLM）：LESCOL XL 氟伐他汀钠 80 mg 缓释片当前美国公开标签（2023-11 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8a1823e7-26fb-4858-bac7-9e152e5ea16a", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, { "id": "src_fcba6e98b5ba90b4", "label": "FDA：LESCOL XL NDA 021192／S-031 标签补充批准函（2020）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/021192Orig1s031ltr.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "regulatory_approval_document", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, { "id": "src_c6710913079ea037", "label": "Novartis：LESCOL／氟伐他汀钠公开产品资料页", "url": "https://www.novartis.com/node/35261", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "first_party_product_page", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" } ], "applicationNumber": "NDA 021192", "approvalTimeline": [ { "date": "1993", "title": { "zh": "氟伐他汀美国初始批准年份", "en": "Initial U.S. approval year for fluvastatin" }, "detail": { "zh": "当前 LESCOL XL 美国公开标签列示 Initial U.S. Approval: 1993。该年份定位美国品牌历史，不建立其他市场状态。", "en": "The current U.S. LESCOL XL label states Initial U.S. Approval: 1993. This date locates U.S. brand history and does not establish another market's status." }, "source": { "id": "src_cbe7ec1a9ebc15ae", "label": "DailyMed（NLM）：LESCOL XL 氟伐他汀钠 80 mg 缓释片当前美国公开标签（2023-11 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8a1823e7-26fb-4858-bac7-9e152e5ea16a", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" } }, { "date": "2020", "title": { "zh": "NDA 021192／S-031 标签补充批准", "en": "NDA 021192/S-031 supplemental labelling approval" }, "detail": { "zh": "FDA 补充批准函记录 LESCOL XL 标签更新，包含他汀类新的免疫介导坏死性肌病安全信息。", "en": "The FDA supplemental approval letter records a LESCOL XL label update including new statin-class safety information on immune-mediated necrotising myopathy." }, "source": { "id": "src_fcba6e98b5ba90b4", "label": "FDA：LESCOL XL NDA 021192／S-031 标签补充批准函（2020）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/021192Orig1s031ltr.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "regulatory_approval_document", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" } }, { "date": "2023-11", "title": { "zh": "当前公开标签修订", "en": "Current public-label revision" }, "detail": { "zh": "DailyMed 当前页面列示 2023-11 修订标签及 30 片瓶装官方面板；100 片瓶装另有 2021-02-28 营销终止日期。", "en": "The current DailyMed page lists the label revised Nov 2023 and an official 30-tablet bottle panel; the 100-tablet bottle separately carries a 28 Feb 2021 marketing-end date." }, "source": { "id": "src_cbe7ec1a9ebc15ae", "label": "DailyMed（NLM）：LESCOL XL 氟伐他汀钠 80 mg 缓释片当前美国公开标签（2023-11 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8a1823e7-26fb-4858-bac7-9e152e5ea16a", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" } }, { "date": "2026-08-30", "title": { "zh": "公开来源访问复核", "en": "Public-source access review" }, "detail": { "zh": "本轮确认 DailyMed、FDA 与 Novartis 资料入口可访问。入口存在不等于实时供应或个人适用。", "en": "This review confirmed access to the DailyMed, FDA and Novartis source entries. Source availability does not establish real-time supply or individual suitability." }, "source": { "id": "src_c6710913079ea037", "label": "Novartis：LESCOL／氟伐他汀钠公开产品资料页", "url": "https://www.novartis.com/node/35261", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "first_party_product_page", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "当前公开标签已链接；实时供应未建立", "en": "Current public label linked; real-time supply not established" }, "detail": { "zh": "30 片瓶装有当前标签面板；100 片瓶装保留有日期营销终止记录。两者不能合并成实时库存结论。", "en": "The 30-tablet bottle has a current-label panel, while the 100-tablet bottle retains a dated marketing-end record. They cannot be merged into a real-time inventory conclusion." } }, { "market": { "zh": "中国大陆、欧盟、日本及其他市场", "en": "Mainland China, EU, Japan and other markets" }, "status": { "zh": "现行产品记录待逐市场建立", "en": "Current product records require market-by-market review" }, "detail": { "zh": "不从美国 LESCOL XL 标签外推其他市场的商品名、批准、规格、包装、持有人、供应或可替代性。", "en": "The U.S. LESCOL XL label is not extrapolated to another market's brand, approval, strength, package, holder, supply or interchangeability." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "两粒 40 mg 氟伐他汀胶囊是否等于一片 LESCOL XL 80 mg？", "en": "Do two 40 mg fluvastatin capsules equal one LESCOL XL 80 mg tablet?" }, "answer": { "zh": "不能由网页只按总毫克数判定。普通胶囊与缓释片的剂型和释放结构不同，准确产品、标签、处方和目标市场必须一起核对；不要自行拼接或替换。", "en": "A webpage cannot decide this from the total milligrams alone. Conventional capsules and extended-release tablets have different forms and release designs. Check the exact product, label, prescription and target market together; do not self-assemble or substitute." } }, { "question": { "zh": "可以一天吃 LESCOL XL、一天吃另一种他汀吗？", "en": "Can LESCOL XL be taken one day and another statin the next?" }, "answer": { "zh": "网页不能为个人确认这种轮换。不同他汀不是按毫克数直接等量，强度、相互作用、肝肾功能和处方目标可能不同。不要自行轮换、叠加或停用，应把实际药盒、处方、化验和完整药单交给开方团队或药师核对。", "en": "A webpage cannot confirm such rotation for an individual. Statins are not directly milligram-equivalent, and intensity, interactions, liver/kidney function and prescribing goals may differ. Do not self-rotate, combine or stop them; take the actual packs, prescription, laboratory data and complete medicine list to the prescribing team or pharmacist." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "dosage-forms-are-part-of-medicine-identity", "statin-gene-testing-what-labels-can-and-cannot-say" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/lescol-xl-fluvastatin/", "en": "https://origindrug.com/en/drugs/lescol-xl-fluvastatin/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "mevalotin-pravastatin", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-30", "status": "published_traceable_archive" }, "names": { "brand": "MEVALOTIN", "generic": "普伐他汀钠", "aliases": [ "Mevalotin", "メバロチン", "pravastatin", "pravastatin sodium", "普伐他汀", "普伐他汀钠" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "心血管", "sourceArchiveMarket": "日本 PMDA 当前 MEVALOTIN 5 mg／10 mg 片及 0.5%／1% 细粒产品页、电子说明书与患者用药指南", "dosageFormClass": "日本 PMDA：普伐他汀钠 5 mg、10 mg 口服片；0.5%、1% 口服细粒（四个产品身份须分别核对）", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "1989（第一三共历史页记载 MEVALOTIN 全球上市）", "archiveSponsorText": "第一三共株式会社（PMDA 当前日本产品页所列制造销售方）" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [ "MEVALOTIN", "メバロチン錠5", "メバロチン錠10", "メバロチン細粒0.5%", "メバロチン細粒1%" ], "excludedProductCues": [ "PRAVACHOL", "PRAVACHOL 40 mg", "pravastatin 20 mg", "pravastatin 40 mg", "pravastatin 80 mg", "普伐他汀 20 mg", "普伐他汀 40 mg", "普伐他汀 80 mg" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "jp-mevalotin-pravastatin-tablet-5mg-current", "marketCode": "JP", "labelVersion": { "zh": "PMDA 当前日本电子说明书（2023-07 修订）", "en": "Current Japanese PMDA electronic label (revised Jul 2023)" }, "dosageForm": { "zh": "MEVALOTIN（メバロチン）普伐他汀钠 5 mg 口服片", "en": "MEVALOTIN pravastatin sodium 5 mg oral tablet" }, "route": { "zh": "口服（准确产品身份字段）", "en": "oral (exact product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "PMDA approval no. 21300AMZ00549", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片含普伐他汀钠 5 mg", "en": "Pravastatin sodium 5 mg per tablet" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "普伐他汀钠", "en": "pravastatin sodium" }, "value": 5, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、频率、换药或掰片指令", "en": "labelled amount per tablet; not an individual's tablet count, frequency, switching or splitting instruction" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-30", "currentLabelDisplayed": true, "ndcDirectoryListed": false, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": null, "physicalClues": { "color": { "zh": "白色", "en": "white" }, "shape": { "zh": "圆形素片、无刻痕", "en": "round uncoated unscored tablet" }, "imprint": "SANKYO 231", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_2d10a23407238f30", "label": "PMDA：メバロチン（普伐他汀钠）当前日本电子说明书（2023-07 修订）", "url": "https://www.pmda.go.jp/PmdaSearch/iyakuDetail/ResultDataSetPDF/430574_2189010C1032_2_15", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "jp-mevalotin-pravastatin-tablet-10mg-current", "marketCode": "JP", "labelVersion": { "zh": "PMDA 当前日本电子说明书（2023-07 修订）", "en": "Current Japanese PMDA electronic label (revised Jul 2023)" }, "dosageForm": { "zh": "MEVALOTIN（メバロチン）普伐他汀钠 10 mg 口服片", "en": "MEVALOTIN pravastatin sodium 10 mg oral tablet" }, "route": { "zh": "口服（准确产品身份字段）", "en": "oral (exact product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "PMDA approval no. 20300AMZ00671", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片含普伐他汀钠 10 mg", "en": "Pravastatin sodium 10 mg per tablet" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "普伐他汀钠", "en": "pravastatin sodium" }, "value": 10, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、频率、换药或掰片指令", "en": "labelled amount per tablet; not an individual's tablet count, frequency, switching or splitting instruction" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-30", "currentLabelDisplayed": true, "ndcDirectoryListed": false, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": null, "physicalClues": { "color": { "zh": "微红色", "en": "pale red" }, "shape": { "zh": "圆形素片、有刻痕；刻痕不是自行掰片许可", "en": "round uncoated scored tablet; the score is not permission to self-split" }, "imprint": "SANKYO 232", "scoreStatus": "scored_status_not_a_split_instruction", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_2d10a23407238f30", "label": "PMDA：メバロチン（普伐他汀钠）当前日本电子说明书（2023-07 修订）", "url": "https://www.pmda.go.jp/PmdaSearch/iyakuDetail/ResultDataSetPDF/430574_2189010C1032_2_15", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "jp-mevalotin-pravastatin-fine-granules-0-5pct-current", "marketCode": "JP", "labelVersion": { "zh": "PMDA 当前日本电子说明书（2023-07 修订）", "en": "Current Japanese PMDA electronic label (revised Jul 2023)" }, "dosageForm": { "zh": "MEVALOTIN（メバロチン）普伐他汀钠细粒 0.5%", "en": "MEVALOTIN pravastatin sodium 0.5% fine granules" }, "route": { "zh": "口服（准确产品身份字段）", "en": "oral (exact product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "PMDA approval no. 21300AMZ00548", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_g", "primaryDisplay": { "zh": "每 1 g 细粒含普伐他汀钠 5 mg（0.5%）", "en": "Pravastatin sodium 5 mg per 1 g of fine granules (0.5%)" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "普伐他汀钠", "en": "pravastatin sodium" }, "value": 5, "unit": "mg", "basisCode": "per_g", "basisLabel": { "zh": "每 1 g 细粒的标签标示量；不是个人克数、频率或片剂换算", "en": "labelled amount per 1 g of fine granules; not an individual's gram amount, frequency or tablet conversion" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-30", "currentLabelDisplayed": true, "ndcDirectoryListed": false, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": null, "physicalClues": { "color": { "zh": "白色", "en": "white" }, "shape": { "zh": "细粒剂；不能用片剂外观核对", "en": "fine granules; not identifiable by tablet appearance" }, "imprint": null, "scoreStatus": "not_applicable", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_2d10a23407238f30", "label": "PMDA：メバロチン（普伐他汀钠）当前日本电子说明书（2023-07 修订）", "url": "https://www.pmda.go.jp/PmdaSearch/iyakuDetail/ResultDataSetPDF/430574_2189010C1032_2_15", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "jp-mevalotin-pravastatin-fine-granules-1pct-current", "marketCode": "JP", "labelVersion": { "zh": "PMDA 当前日本电子说明书（2023-07 修订）", "en": "Current Japanese PMDA electronic label (revised Jul 2023)" }, "dosageForm": { "zh": "MEVALOTIN（メバロチン）普伐他汀钠细粒 1%", "en": "MEVALOTIN pravastatin sodium 1% fine granules" }, "route": { "zh": "口服（准确产品身份字段）", "en": "oral (exact product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "PMDA approval no. 20300AMZ00672", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_g", "primaryDisplay": { "zh": "每 1 g 细粒含普伐他汀钠 10 mg（1%）", "en": "Pravastatin sodium 10 mg per 1 g of fine granules (1%)" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "普伐他汀钠", "en": "pravastatin sodium" }, "value": 10, "unit": "mg", "basisCode": "per_g", "basisLabel": { "zh": "每 1 g 细粒的标签标示量；不是个人克数、频率或片剂换算", "en": "labelled amount per 1 g of fine granules; not an individual's gram amount, frequency or tablet conversion" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-30", "currentLabelDisplayed": true, "ndcDirectoryListed": false, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": null, "physicalClues": { "color": { "zh": "微红色", "en": "pale red" }, "shape": { "zh": "细粒剂；不能用片剂外观核对", "en": "fine granules; not identifiable by tablet appearance" }, "imprint": null, "scoreStatus": "not_applicable", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_2d10a23407238f30", "label": "PMDA：メバロチン（普伐他汀钠）当前日本电子说明书（2023-07 修订）", "url": "https://www.pmda.go.jp/PmdaSearch/iyakuDetail/ResultDataSetPDF/430574_2189010C1032_2_15", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [ { "id": "jp-mevalotin-tablet-5mg-pmda-guide-2023", "marketCode": "JP", "visualKind": "official_patient_guide_dosage_form_appearance", "title": { "zh": "MEVALOTIN（普伐他汀钠）5 mg 片剂泡罩局部", "en": "MEVALOTIN (pravastatin sodium) 5 mg tablet blister detail" }, "imageUrl": "/evidence/medicine/mevalotin-pravastatin/mevalotin-tablet-5mg-pmda-guide-2023.jpeg", "alt": { "zh": "日本 PMDA 指南中的 MEVALOTIN 5 mg 片剂泡罩局部原图", "en": "Original Japan PMDA guide image of MEVALOTIN 5 mg tablet blister detail" }, "description": { "zh": "2023 年 7 月版日本 PMDA 患者指南第 4 页：5 mg 片剂泡罩局部。图片按原样提取，2026 年 9 月 8 日核对。", "en": "Page 4 of the July 2023 Japan PMDA patient guide: 5 mg tablet blister detail. Extracted without image alteration; checked 8 September 2026." }, "exclusions": { "zh": "不是整盒包装图，不是中国市场包装，不是真伪证明，也不是个人用量或自行掰片的依据。", "en": "Not an exact outer-package image, not a China-market pack, not authentication, and not an individual amount or self-splitting instruction." }, "source": { "id": "src_50147f1d11000ec1", "label": "PMDA：メバロチン患者用药指南（2023-07 更新）", "url": "https://www.info.pmda.go.jp/downfiles/guide/ph/430574_2189010C1032_2_00G.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "patient_medication_guide", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-08", "reviewedAt": "2026-09-08" }, "scope": "official_dosage_form_appearance_only_not_outer_package_authentication_or_personal_use" }, { "id": "jp-mevalotin-tablet-10mg-pmda-guide-2023", "marketCode": "JP", "visualKind": "official_patient_guide_dosage_form_appearance", "title": { "zh": "MEVALOTIN（普伐他汀钠）10 mg 片剂泡罩局部", "en": "MEVALOTIN (pravastatin sodium) 10 mg tablet blister detail" }, "imageUrl": "/evidence/medicine/mevalotin-pravastatin/mevalotin-tablet-10mg-pmda-guide-2023.jpeg", "alt": { "zh": "日本 PMDA 指南中的 MEVALOTIN 10 mg 片剂泡罩局部原图", "en": "Original Japan PMDA guide image of MEVALOTIN 10 mg tablet blister detail" }, "description": { "zh": "2023 年 7 月版日本 PMDA 患者指南第 4 页：10 mg 片剂泡罩局部。图片按原样提取，2026 年 9 月 8 日核对。", "en": "Page 4 of the July 2023 Japan PMDA patient guide: 10 mg tablet blister detail. Extracted without image alteration; checked 8 September 2026." }, "exclusions": { "zh": "不是整盒包装图，不是中国市场包装，不是真伪证明，也不是个人用量或自行掰片的依据。", "en": "Not an exact outer-package image, not a China-market pack, not authentication, and not an individual amount or self-splitting instruction." }, "source": { "id": "src_50147f1d11000ec1", "label": "PMDA：メバロチン患者用药指南（2023-07 更新）", "url": "https://www.info.pmda.go.jp/downfiles/guide/ph/430574_2189010C1032_2_00G.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "patient_medication_guide", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-08", "reviewedAt": "2026-09-08" }, "scope": "official_dosage_form_appearance_only_not_outer_package_authentication_or_personal_use" }, { "id": "jp-mevalotin-fine-granules-0-5pct-pmda-guide-2023", "marketCode": "JP", "visualKind": "official_patient_guide_dosage_form_appearance", "title": { "zh": "MEVALOTIN（普伐他汀钠）0.5% 细粒", "en": "MEVALOTIN (pravastatin sodium) 0.5% fine granules" }, "imageUrl": "/evidence/medicine/mevalotin-pravastatin/mevalotin-fine-granules-0-5pct-pmda-guide-2023.jpeg", "alt": { "zh": "日本 PMDA 指南中的 MEVALOTIN 0.5% 细粒原图", "en": "Original Japan PMDA guide image of MEVALOTIN 0.5% fine granules" }, "description": { "zh": "2023 年 7 月版日本 PMDA 患者指南第 4 页：0.5% 细粒。图片按原样提取，2026 年 9 月 8 日核对。", "en": "Page 4 of the July 2023 Japan PMDA patient guide: 0.5% fine granules. Extracted without image alteration; checked 8 September 2026." }, "exclusions": { "zh": "不是整盒包装图，不是中国市场包装，不是真伪证明，也不是个人用量或自行掰片的依据。", "en": "Not an exact outer-package image, not a China-market pack, not authentication, and not an individual amount or self-splitting instruction." }, "source": { "id": "src_50147f1d11000ec1", "label": "PMDA：メバロチン患者用药指南（2023-07 更新）", "url": "https://www.info.pmda.go.jp/downfiles/guide/ph/430574_2189010C1032_2_00G.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "patient_medication_guide", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-08", "reviewedAt": "2026-09-08" }, "scope": "official_dosage_form_appearance_only_not_outer_package_authentication_or_personal_use" }, { "id": "jp-mevalotin-fine-granules-1pct-pmda-guide-2023", "marketCode": "JP", "visualKind": "official_patient_guide_dosage_form_appearance", "title": { "zh": "MEVALOTIN（普伐他汀钠）1% 细粒", "en": "MEVALOTIN (pravastatin sodium) 1% fine granules" }, "imageUrl": "/evidence/medicine/mevalotin-pravastatin/mevalotin-fine-granules-1pct-pmda-guide-2023.jpeg", "alt": { "zh": "日本 PMDA 指南中的 MEVALOTIN 1% 细粒原图", "en": "Original Japan PMDA guide image of MEVALOTIN 1% fine granules" }, "description": { "zh": "2023 年 7 月版日本 PMDA 患者指南第 4 页：1% 细粒。图片按原样提取，2026 年 9 月 8 日核对。", "en": "Page 4 of the July 2023 Japan PMDA patient guide: 1% fine granules. Extracted without image alteration; checked 8 September 2026." }, "exclusions": { "zh": "不是整盒包装图，不是中国市场包装，不是真伪证明，也不是个人用量或自行掰片的依据。", "en": "Not an exact outer-package image, not a China-market pack, not authentication, and not an individual amount or self-splitting instruction." }, "source": { "id": "src_50147f1d11000ec1", "label": "PMDA：メバロチン患者用药指南（2023-07 更新）", "url": "https://www.info.pmda.go.jp/downfiles/guide/ph/430574_2189010C1032_2_00G.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "patient_medication_guide", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-08", "reviewedAt": "2026-09-08" }, "scope": "official_dosage_form_appearance_only_not_outer_package_authentication_or_personal_use" } ], "visualReference": { "status": "withheld_repackaged_or_non_exact_visual", "title": { "zh": "已有官方指南外观参考；仍不展示无法逐包装对应的整盒图", "en": "Official guide appearance references are available; exact outer-package images remain withheld" }, "summary": { "zh": "本页另列 2023 年 7 月版日本 PMDA 患者指南中的 5 mg、10 mg 泡罩局部及 0.5%、1% 细粒原图，可点击放大。仍未核验逐包装对应的整盒主展示面，因此不展示整盒包装图。指南外观不能证明中国或其他市场药盒的身份、真伪、供应或个人适用性。", "en": "This page separately shows unaltered 5 mg and 10 mg blister details and 0.5% and 1% fine-granule images from the July 2023 Japan PMDA patient guide, with enlargement. An exact outer-carton principal display panel has not been verified, so outer-package images remain withheld. Guide appearances do not establish identity, authenticity, availability or individual suitability for China or another market." }, "source": { "id": "src_2d10a23407238f30", "label": "PMDA：メバロチン（普伐他汀钠）当前日本电子说明书（2023-07 修订）", "url": "https://www.pmda.go.jp/PmdaSearch/iyakuDetail/ResultDataSetPDF/430574_2189010C1032_2_15", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "MEVALOTIN 说明书放大阅读：5 mg、10 mg、0.5% 与 1% 不是同一种计量基准", "en": "MEVALOTIN label reading: 5 mg, 10 mg, 0.5% and 1% do not share one measurement basis" }, "summary": { "zh": "PMDA 当前档案把 MEVALOTIN 分为每片 5 mg、每片 10 mg，以及每 1 g 细粒含 5 mg（0.5%）或 10 mg（1%）。本模块帮助核对准确剂型、每单位标示量、妊娠/哺乳边界、肝功能与严重肌肉损伤警示；不提供个人片数、克数、频率、换药或停药方案。", "en": "The current PMDA record separates MEVALOTIN into 5 mg per tablet, 10 mg per tablet, 5 mg per 1 g of fine granules (0.5%), and 10 mg per 1 g (1%). This module helps check the exact form, amount per labelled unit, pregnancy/breastfeeding boundary, liver function and serious muscle-injury warning. It provides no individual tablet or gram count, frequency, switching or stopping plan." }, "checks": [ { "zh": "5 mg／10 mg 片说的是每片标示量；0.5%／1% 细粒说的是每 1 g 细粒所含 5 mg／10 mg。百分比、每克和每片不能在网页上凭数字直接互换，更不能据此推算个人吃多少。", "en": "The 5 mg and 10 mg tablets state an amount per tablet; the 0.5% and 1% granules state 5 mg or 10 mg per 1 g of granules. Percent, per-gram and per-tablet units cannot be directly converted from numbers on a webpage or used to calculate an individual's amount." }, { "zh": "PMDA 说明书把妊妇、可能妊娠者及哺乳期列入禁忌/重要边界。正在备孕、可能怀孕、怀孕或哺乳时，不要凭网页自行继续、停用、隔天吃或换成另一种他汀，应尽快联系开方团队或药师。", "en": "The PMDA label places pregnancy, possible pregnancy and breastfeeding within contraindication/important-use boundaries. When planning pregnancy, possibly pregnant, pregnant or breastfeeding, do not self-continue, stop, alternate days or switch statins from this page; contact the prescribing team or pharmacist promptly." }, { "zh": "无法解释的肌肉痛、压痛、无力、抽筋，尤其伴明显乏力、发热或深色尿，可能需要尽快医疗评估；说明书列有横纹肌溶解等严重肌肉损伤警示。不要等待网页判断是否由药物引起。", "en": "Unexplained muscle pain, tenderness, weakness or cramps, especially with marked fatigue, fever or dark urine, may need prompt medical assessment. The label includes serious muscle-injury warnings such as rhabdomyolysis. Do not wait for a webpage to decide whether a medicine caused the symptoms." }, { "zh": "肝功能问题、肾功能问题、甲状腺问题、既往肌肉不良反应以及贝特类、免疫抑制剂或其他降脂药等完整药单都可能影响专业判断。网页不会根据一个药名或一次化验自动决定是否适合、是否需要基因筛查或怎样换他汀。", "en": "Liver or kidney problems, thyroid conditions, previous muscle reactions and a complete medicine list including fibrates, immunosuppressants or other lipid-lowering medicines may affect professional judgement. The site does not decide suitability, need for genetic testing or how to switch statins from one medicine name or laboratory result." }, { "zh": "10 mg 片有刻痕仅是 PMDA 外观字段，不等于任何人都能自行掰半；5 mg 片无刻痕，细粒又是另一剂型。改变剂型、掰片、研磨、混合食物或用另一规格拼接前，应核对实际包装和现行处方。", "en": "The score on the 10 mg tablet is a PMDA appearance field, not permission for everyone to self-split; the 5 mg tablet is unscored and the fine granules are another dosage form. Before changing form, splitting, crushing, mixing with food or combining strengths, check the actual pack and current prescription." } ], "source": { "id": "src_50147f1d11000ec1", "label": "PMDA：メバロチン患者用药指南（2023-07 更新）", "url": "https://www.info.pmda.go.jp/downfiles/guide/ph/430574_2189010C1032_2_00G.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "patient_medication_guide", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-08", "reviewedAt": "2026-09-08" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "普伐他汀怎样起作用：抑制 HMG-CoA 还原酶，不等于所有他汀可以轮换", "en": "How pravastatin works: inhibiting HMG-CoA reductase does not make all statins interchangeable" }, "summary": { "zh": "PMDA 资料将普伐他汀归为 HMG-CoA 还原酶抑制剂，并说明其通过抑制肝脏和小肠中的胆固醇合成发挥作用。这个机制帮助理解药物类别，但不能决定某个人应使用哪一种他汀、多少强度、是否隔天轮换或是否需要全基因筛查。", "en": "PMDA material classifies pravastatin as an HMG-CoA reductase inhibitor and describes inhibition of cholesterol synthesis in the liver and small intestine. This mechanism helps explain the class but cannot decide which statin, strength, alternate-day switch or whole-genome testing an individual needs." }, "checks": [ { "zh": "同属他汀不表示 MEVALOTIN、阿托伐他汀、瑞舒伐他汀、辛伐他汀可按毫克数自行等量替换、每天轮换或叠加。强度、相互作用、肝肾功能、适应症和处方目标都要分别核对。", "en": "A shared statin class does not make MEVALOTIN, atorvastatin, rosuvastatin or simvastatin milligram-equivalent, self-switchable day by day or combinable. Strength, interactions, liver/kidney function, indication and prescribing goal need separate review." }, { "zh": "药物作用机制不能从症状、年龄或一项胆固醇结果直接推导个人用药。完整病史、化验、药单和目标市场现行说明书才是与开方团队讨论的基础。", "en": "Mechanism cannot turn symptoms, age or one cholesterol result into an individual medicine decision. Complete history, laboratory data, medicine list and the current target-market label are the basis for discussion with the prescribing team." }, { "zh": "基因信息有时可参与特定药物风险解释，但“他汀”三个字不等于人人需要全基因组筛查。是否检测、检测哪一项及怎样解释必须由合格专业人员结合实际药物和临床背景决定。", "en": "Genetic information can sometimes inform interpretation of specific medicine risks, but the word “statin” does not mean everyone needs whole-genome screening. Whether to test, what to test and how to interpret it require a qualified professional using the actual medicine and clinical context." } ], "source": { "id": "src_2d10a23407238f30", "label": "PMDA：メバロチン（普伐他汀钠）当前日本电子说明书（2023-07 修订）", "url": "https://www.pmda.go.jp/PmdaSearch/iyakuDetail/ResultDataSetPDF/430574_2189010C1032_2_15", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "MEVALOTIN", "generic": "普伐他汀钠", "dosageFormClass": "日本 PMDA：普伐他汀钠 5 mg、10 mg 口服片；0.5%、1% 口服细粒（四个产品身份须分别核对）" }, "labelSource": { "id": "src_232ce8a63d78c6f2", "label": "PMDA：メバロチン錠 5／10、细粒 0.5%／1% 当前日本产品页", "url": "https://www.pmda.go.jp/PmdaSearch/rdDetail/iyaku/2189010C1032_2", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "productRoutes": [ { "source": { "id": "src_232ce8a63d78c6f2", "label": "PMDA：メバロチン錠 5／10、细粒 0.5%／1% 当前日本产品页", "url": "https://www.pmda.go.jp/PmdaSearch/rdDetail/iyaku/2189010C1032_2", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "status": "product_level_public_record_verified", "authority": { "zh": "PMDA", "en": "PMDA" }, "market": { "zh": "日本", "en": "Japan" }, "recordType": { "zh": "监管产品记录", "en": "Regulatory product record" }, "reviewedAt": "2026-08-30", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_2d10a23407238f30", "label": "PMDA：メバロチン（普伐他汀钠）当前日本电子说明书（2023-07 修订）", "url": "https://www.pmda.go.jp/PmdaSearch/iyakuDetail/ResultDataSetPDF/430574_2189010C1032_2_15", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "status": "product_level_public_record_verified", "authority": { "zh": "PMDA", "en": "PMDA" }, "market": { "zh": "日本", "en": "Japan" }, "recordType": { "zh": "监管产品记录", "en": "Regulatory product record" }, "reviewedAt": "2026-08-30", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "PMDA", "en": "PMDA" }, "market": { "zh": "日本", "en": "Japan" }, "recordType": { "zh": "监管产品记录", "en": "Regulatory product record" }, "reviewedAt": "2026-08-30", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "MEVALOTIN（メバロチン）是日本 PMDA 当前列示的普伐他汀钠品牌档案，覆盖 5 mg、10 mg 口服片和 0.5%、1% 细粒。页面把“每片 mg”和“每 1 g 细粒所含 mg”分开，帮助普通读者核对品牌、通用名、剂型、强度、外观文字与说明书；不从包装数字计算个人片数、克数、频率，也不把它与阿托伐他汀、瑞舒伐他汀或另一市场的普伐他汀自行换算。", "history": "第一三共历史资料记录其三共前身在他汀研发中的历史，并将 MEVALOTIN 的全球上市列为重要节点；PMDA 当前产品页列示四个日本产品及第一三共为制造销售方。历史和当前日本记录用于来源定位，不能外推其他市场。", "sourceDocuments": [ { "id": "src_232ce8a63d78c6f2", "label": "PMDA：メバロチン錠 5／10、细粒 0.5%／1% 当前日本产品页", "url": "https://www.pmda.go.jp/PmdaSearch/rdDetail/iyaku/2189010C1032_2", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, { "id": "src_2d10a23407238f30", "label": "PMDA：メバロチン（普伐他汀钠）当前日本电子说明书（2023-07 修订）", "url": "https://www.pmda.go.jp/PmdaSearch/iyakuDetail/ResultDataSetPDF/430574_2189010C1032_2_15", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, { "id": "src_50147f1d11000ec1", "label": "PMDA：メバロチン患者用药指南（2023-07 更新）", "url": "https://www.info.pmda.go.jp/downfiles/guide/ph/430574_2189010C1032_2_00G.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "patient_medication_guide", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-08", "reviewedAt": "2026-09-08" }, { "id": "src_6cc8d719b40c0755", "label": "第一三共：三共研发历史与 MEVALOTIN 全球上市记录", "url": "https://www.daiichisankyo.com/about_us/mission-strength/history/sankyo/index.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "first_party_product_history", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" } ], "applicationNumber": "日本承认番号 21300AMZ00549／20300AMZ00671／21300AMZ00548／20300AMZ00672", "approvalTimeline": [ { "date": "1989", "title": { "zh": "MEVALOTIN 全球上市历史节点", "en": "MEVALOTIN global-launch history milestone" }, "detail": { "zh": "第一三共历史页把 MEVALOTIN 列为三共研发的突破性 HMG-CoA 还原酶抑制剂，并记录其全球上市。该历史节点不替代当前市场批准记录。", "en": "Daiichi Sankyo's history page lists MEVALOTIN as a groundbreaking HMG-CoA reductase inhibitor developed by Sankyo and records its global launch. This history milestone does not replace current market approval records." }, "source": { "id": "src_6cc8d719b40c0755", "label": "第一三共：三共研发历史与 MEVALOTIN 全球上市记录", "url": "https://www.daiichisankyo.com/about_us/mission-strength/history/sankyo/index.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "first_party_product_history", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" } }, { "date": "2023-07", "title": { "zh": "PMDA 当前链接电子说明书修订", "en": "Revision date of the electronic label currently linked by PMDA" }, "detail": { "zh": "PMDA 当前产品页链接 2023-07 修订的电子说明书和患者用药指南，覆盖 5 mg、10 mg 片与 0.5%、1% 细粒。日期定位文件版本，不表示其他市场状态或任何人的开始用药日期。", "en": "The current PMDA product page links a label and patient guide revised in Jul 2023, covering 5 mg and 10 mg tablets and 0.5% and 1% fine granules. The date identifies the document version; it does not establish another market's status or anyone's start date." }, "source": { "id": "src_2d10a23407238f30", "label": "PMDA：メバロチン（普伐他汀钠）当前日本电子说明书（2023-07 修订）", "url": "https://www.pmda.go.jp/PmdaSearch/iyakuDetail/ResultDataSetPDF/430574_2189010C1032_2_15", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" } }, { "date": "2026-08-30", "title": { "zh": "PMDA 当前产品页访问复核", "en": "Current PMDA product-page access review" }, "detail": { "zh": "本次复核确认 PMDA 产品页仍列示四个 MEVALOTIN 产品并指向第一三共。页面存在不等于任何地点有库存、可购买或适合个人。", "en": "This review confirmed that the PMDA product page still lists four MEVALOTIN products and Daiichi Sankyo. Page availability does not establish stock, purchase availability or individual suitability." }, "source": { "id": "src_232ce8a63d78c6f2", "label": "PMDA：メバロチン錠 5／10、细粒 0.5%／1% 当前日本产品页", "url": "https://www.pmda.go.jp/PmdaSearch/rdDetail/iyaku/2189010C1032_2", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" } } ], "marketStatus": [ { "market": { "zh": "日本", "en": "Japan" }, "status": { "zh": "已链接 PMDA 当前产品页、电子说明书和患者指南", "en": "Current PMDA product page, electronic label and patient guide linked" }, "detail": { "zh": "四个日本产品身份分别记录；没有从说明书存在推定库存、价格、处方资格或个人适用性。", "en": "The four Japanese product identities are recorded separately; label availability does not establish stock, price, prescription eligibility or individual suitability." } }, { "market": { "zh": "中国大陆、美国、欧盟及其他市场", "en": "Mainland China, United States, EU and other markets" }, "status": { "zh": "现行产品记录待逐市场建立", "en": "Current product records require market-by-market review" }, "detail": { "zh": "不从日本 MEVALOTIN、第一三共研发历史或普伐他汀通用名推定 PRAVACHOL 或其他市场的当前批准、规格、包装、供应、原研/仿制关系和可替代性。", "en": "Japan MEVALOTIN, Daiichi Sankyo development history and the pravastatin generic name do not establish current approval, strength, packaging, supply, originator/generic status or interchangeability for PRAVACHOL or another market." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "5 mg 片和 0.5% 细粒是不是一个意思？", "en": "Do a 5 mg tablet and 0.5% fine granules mean the same thing?" }, "answer": { "zh": "不是同一种标示基准。5 mg 片是每片含 5 mg；0.5% 细粒在该说明书中是每 1 g 细粒含 5 mg。剂型、计量单位和实际处方必须一起核对，不能只看数字相同就互换。", "en": "They do not use the same labelled basis. A 5 mg tablet contains 5 mg per tablet; the 0.5% granules in this label contain 5 mg per 1 g of granules. Form, unit and actual prescription must be checked together; matching numbers do not make them interchangeable." } }, { "question": { "zh": "可以一天吃普伐他汀、一天吃阿托伐他汀或瑞舒伐他汀吗？", "en": "Can pravastatin be taken one day and atorvastatin or rosuvastatin the next?" }, "answer": { "zh": "网页不能为个人确认这种轮换。不同他汀不是按毫克数直接等量，适应症、强度、相互作用、肝肾功能和处方目标都可能不同。不要自行轮换、叠加或停用，应把实际药盒、处方、化验和完整药单交给开方团队或药师核对。", "en": "A webpage cannot confirm such alternating use for an individual. Statins are not directly milligram-equivalent, and indication, intensity, interactions, liver/kidney function and prescribing goals may differ. Do not self-alternate, combine or stop them; take the actual packs, prescription, laboratory data and complete medicine list to the prescribing team or pharmacist." } }, { "question": { "zh": "10 mg 片有刻痕，是不是可以自己掰成 5 mg？", "en": "Does the score on the 10 mg tablet mean it can be self-split into 5 mg?" }, "answer": { "zh": "不能只凭刻痕作决定。刻痕是说明书外观字段，是否可以分割、分割后的剂量准确性、稳定性和是否符合个人处方，需要核对实际产品说明书并由药师或开方团队确认。", "en": "A score alone does not decide this. It is a label appearance field. Whether the actual product may be divided, the accuracy and stability after splitting, and whether that matches the individual prescription require the exact label and pharmacist or prescriber review." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "dosage-forms-are-part-of-medicine-identity", "statin-gene-testing-what-labels-can-and-cannot-say" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/mevalotin-pravastatin/", "en": "https://origindrug.com/en/drugs/mevalotin-pravastatin/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "celexa", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-30", "status": "published_traceable_archive" }, "names": { "brand": "CELEXA", "generic": "西酞普兰", "aliases": [ "Celexa", "citalopram", "citalopram hydrobromide", "西酞普兰", "氢溴酸西酞普兰", "西酞普兰片", "NDA 020822", "0456-4010-01", "0456-4020-01", "0456-4020-63", "0456-4040-01", "0456-4040-63", "FP 10 mg", "F P 20 mg", "F P 40 mg" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "精神健康", "sourceArchiveMarket": "美国 DailyMed 当前 CELEXA 西酞普兰口服片标签（SPL v40；2023-10-09 生效；NDA 020822）", "dosageFormClass": "西酞普兰口服薄膜衣片：每片 10 mg、20 mg 或 40 mg；分别记录三种 100 片瓶装和两种 100 片单位剂量纸盒身份", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "1998", "archiveSponsorText": "Allergan, Inc.（DailyMed 标签 packager；包装面板列 AbbVie）" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [ "LEXAPRO", "escitalopram", "艾司西酞普兰", "citalopram oral solution", "西酞普兰口服液", "generic citalopram" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-celexa-citalopram-10mg-100-bottle-ndc-0456401001", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（SPL v40；2023-10-09 生效）", "en": "Current U.S. DailyMed public label (SPL v40; effective 9 Oct 2023)" }, "dosageForm": { "zh": "CELEXA 西酞普兰口服薄膜衣片", "en": "CELEXA citalopram oral film-coated tablet" }, "route": { "zh": "口服（准确片剂产品身份字段）", "en": "oral (exact tablet-product identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 0456-4010-01", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片相当于西酞普兰 10 mg；100 片瓶装", "en": "Equivalent to citalopram 10 mg per tablet; 100-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=celexa-02.jpg&setid=4259d9b1-de34-43a4-85a8-41dd214e9177&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "西酞普兰（以氢溴酸西酞普兰提供）", "en": "citalopram (supplied as citalopram hydrobromide)" }, "value": 10, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、频率、掰片或停换药指令", "en": "labelled amount per tablet; not an individual's tablet count, frequency, splitting or stopping/switching instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-30", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "米黄色", "en": "beige" }, "shape": { "zh": "椭圆形薄膜衣片；无刻痕", "en": "oval film-coated tablet; unscored" }, "imprint": "FP / 10 mg", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_90be49e2ccf8797e", "label": "DailyMed（NLM）：CELEXA 10 mg、NDC 0456-4010-01、100 片瓶装当前美国标签身份", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=4259d9b1-de34-43a4-85a8-41dd214e9177", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-celexa-citalopram-20mg-100-bottle-ndc-0456402001", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（SPL v40；2023-10-09 生效）", "en": "Current U.S. DailyMed public label (SPL v40; effective 9 Oct 2023)" }, "dosageForm": { "zh": "CELEXA 西酞普兰口服薄膜衣片", "en": "CELEXA citalopram oral film-coated tablet" }, "route": { "zh": "口服（准确片剂产品身份字段）", "en": "oral (exact tablet-product identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 0456-4020-01", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片相当于西酞普兰 20 mg；100 片瓶装", "en": "Equivalent to citalopram 20 mg per tablet; 100-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=celexa-03.jpg&setid=4259d9b1-de34-43a4-85a8-41dd214e9177&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "西酞普兰（以氢溴酸西酞普兰提供）", "en": "citalopram (supplied as citalopram hydrobromide)" }, "value": 20, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、频率、掰片或停换药指令", "en": "labelled amount per tablet; not an individual's tablet count, frequency, splitting or stopping/switching instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-30", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "粉红色", "en": "pink" }, "shape": { "zh": "椭圆形薄膜衣片；有刻痕，但刻痕只作外观核对，不是自行掰片许可", "en": "oval film-coated tablet; scored, but the score is an appearance clue and not permission to self-split" }, "imprint": "F | P / 20 mg", "scoreStatus": "scored_status_not_a_split_instruction", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_90be49e2ccf8797e", "label": "DailyMed（NLM）：CELEXA 20 mg、NDC 0456-4020-01、100 片瓶装当前美国标签身份", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=4259d9b1-de34-43a4-85a8-41dd214e9177", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-celexa-citalopram-20mg-100-unit-dose-carton-ndc-0456402063", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（SPL v40；2023-10-09 生效）", "en": "Current U.S. DailyMed public label (SPL v40; effective 9 Oct 2023)" }, "dosageForm": { "zh": "CELEXA 西酞普兰口服薄膜衣片", "en": "CELEXA citalopram oral film-coated tablet" }, "route": { "zh": "口服（准确片剂产品身份字段）", "en": "oral (exact tablet-product identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 0456-4020-63; inner blister NDC 0456-4020-11", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片相当于西酞普兰 20 mg；100 片单位剂量纸盒（10 包×10 片）", "en": "Equivalent to citalopram 20 mg per tablet; 100-tablet unit-dose carton (10 packs × 10 tablets)" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "西酞普兰（以氢溴酸西酞普兰提供）", "en": "citalopram (supplied as citalopram hydrobromide)" }, "value": 20, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、频率、掰片或停换药指令", "en": "labelled amount per tablet; not an individual's tablet count, frequency, splitting or stopping/switching instruction" } } ], "concentration": null, "container": { "typeCode": "unit_dose_carton", "typeLabel": { "zh": "单位剂量纸盒", "en": "unit-dose carton" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "片/盒", "en": "tablets per carton" }, "unitsPerContainer": { "count": 10, "unit": { "zh": "片/内层泡罩", "en": "tablets per inner blister" } } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-30", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "片/单位剂量纸盒", "en": "tablets per unit-dose carton" } }, "physicalClues": { "color": { "zh": "粉红色", "en": "pink" }, "shape": { "zh": "椭圆形薄膜衣片；有刻痕，但刻痕只作外观核对，不是自行掰片许可", "en": "oval film-coated tablet; scored, but the score is an appearance clue and not permission to self-split" }, "imprint": "F | P / 20 mg", "scoreStatus": "scored_status_not_a_split_instruction", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_90be49e2ccf8797e", "label": "DailyMed（NLM）：CELEXA 20 mg、NDC 0456-4020-63、100 片单位剂量纸盒（10 包×10 片）当前美国标签身份", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=4259d9b1-de34-43a4-85a8-41dd214e9177", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-celexa-citalopram-40mg-100-bottle-ndc-0456404001", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（SPL v40；2023-10-09 生效）", "en": "Current U.S. DailyMed public label (SPL v40; effective 9 Oct 2023)" }, "dosageForm": { "zh": "CELEXA 西酞普兰口服薄膜衣片", "en": "CELEXA citalopram oral film-coated tablet" }, "route": { "zh": "口服（准确片剂产品身份字段）", "en": "oral (exact tablet-product identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 0456-4040-01", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片相当于西酞普兰 40 mg；100 片瓶装", "en": "Equivalent to citalopram 40 mg per tablet; 100-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=celexa-04.jpg&setid=4259d9b1-de34-43a4-85a8-41dd214e9177&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "西酞普兰（以氢溴酸西酞普兰提供）", "en": "citalopram (supplied as citalopram hydrobromide)" }, "value": 40, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、频率、掰片或停换药指令", "en": "labelled amount per tablet; not an individual's tablet count, frequency, splitting or stopping/switching instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-30", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "白色", "en": "white" }, "shape": { "zh": "椭圆形薄膜衣片；有刻痕，但刻痕只作外观核对，不是自行掰片许可", "en": "oval film-coated tablet; scored, but the score is an appearance clue and not permission to self-split" }, "imprint": "F | P / 40 mg", "scoreStatus": "scored_status_not_a_split_instruction", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_90be49e2ccf8797e", "label": "DailyMed（NLM）：CELEXA 40 mg、NDC 0456-4040-01、100 片瓶装当前美国标签身份", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=4259d9b1-de34-43a4-85a8-41dd214e9177", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-celexa-citalopram-40mg-100-unit-dose-carton-ndc-0456404063", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（SPL v40；2023-10-09 生效）", "en": "Current U.S. DailyMed public label (SPL v40; effective 9 Oct 2023)" }, "dosageForm": { "zh": "CELEXA 西酞普兰口服薄膜衣片", "en": "CELEXA citalopram oral film-coated tablet" }, "route": { "zh": "口服（准确片剂产品身份字段）", "en": "oral (exact tablet-product identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 0456-4040-63; inner blister NDC 0456-4040-11", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片相当于西酞普兰 40 mg；100 片单位剂量纸盒（10 包×10 片）", "en": "Equivalent to citalopram 40 mg per tablet; 100-tablet unit-dose carton (10 packs × 10 tablets)" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "西酞普兰（以氢溴酸西酞普兰提供）", "en": "citalopram (supplied as citalopram hydrobromide)" }, "value": 40, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、频率、掰片或停换药指令", "en": "labelled amount per tablet; not an individual's tablet count, frequency, splitting or stopping/switching instruction" } } ], "concentration": null, "container": { "typeCode": "unit_dose_carton", "typeLabel": { "zh": "单位剂量纸盒", "en": "unit-dose carton" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "片/盒", "en": "tablets per carton" }, "unitsPerContainer": { "count": 10, "unit": { "zh": "片/内层泡罩", "en": "tablets per inner blister" } } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-30", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "片/单位剂量纸盒", "en": "tablets per unit-dose carton" } }, "physicalClues": { "color": { "zh": "白色", "en": "white" }, "shape": { "zh": "椭圆形薄膜衣片；有刻痕，但刻痕只作外观核对，不是自行掰片许可", "en": "oval film-coated tablet; scored, but the score is an appearance clue and not permission to self-split" }, "imprint": "F | P / 40 mg", "scoreStatus": "scored_status_not_a_split_instruction", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_90be49e2ccf8797e", "label": "DailyMed（NLM）：CELEXA 40 mg、NDC 0456-4040-63、100 片单位剂量纸盒（10 包×10 片）当前美国标签身份", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=4259d9b1-de34-43a4-85a8-41dd214e9177", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-celexa-citalopram-20mg-100-bottle-ndc-0456402001", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=celexa-03.jpg&setid=4259d9b1-de34-43a4-85a8-41dd214e9177&type=img", "alt": "CELEXA 西酞普兰 20 mg、NDC 0456-4020-01、100 片瓶装在美国 DailyMed 当前标签中的主展示面", "archiveMarket": "美国", "labelVersion": "DailyMed SPL v40（2023-10-09 生效）", "presentation": "CELEXA 20 mg、NDC 0456-4020-01、100 片瓶装主展示面", "notice": "此图只对应当前美国标签中的 20 mg、100 片瓶装面板，用于核对品牌、通用名、每片标示量、NDC 与包装数量；不用于鉴定真伪，也不证明另一规格、剂型、市场、库存、购买资格或可替代性。", "source": { "id": "src_90be49e2ccf8797e", "label": "DailyMed（NLM）：CELEXA 西酞普兰口服片当前美国公开标签与 Medication Guide（SPL v40；2023-10-09 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=4259d9b1-de34-43a4-85a8-41dd214e9177", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "CELEXA 说明书放大阅读：先分清每片 mg、刻痕、老年与 CYP2C19 边界", "en": "CELEXA label reading: separate mg per tablet, score marks, older-age and CYP2C19 boundaries" }, "summary": { "zh": "当前美国标签分别列出 10、20、40 mg 片，并包含 Medication Guide、黑框警示、QT 延长、血清素综合征、出血、低钠和停药反应等内容。本模块帮助普通读者把准确产品与需要专业复核的问题带回药师或开方团队；不提供个人片数、加减量、掰片、停药或换药方案。", "en": "The current U.S. label separately lists 10, 20 and 40 mg tablets and includes a Medication Guide, boxed warning, QT prolongation, serotonin syndrome, bleeding, hyponatraemia and discontinuation information. This module helps ordinary readers take the exact product and review questions to a pharmacist or prescriber; it gives no personal tablet count, dose change, splitting, stopping or switching plan." }, "checks": [ { "zh": "10、20、40 mg 是每片所含西酞普兰的标签标示量，不是一次吃几片或一天吃几次。20 mg 与 40 mg 片有刻痕、10 mg 片无刻痕；刻痕是产品外观线索，不等于任何人都可以自行掰半，也不能据此用多片小规格替代大规格。", "en": "10, 20 and 40 mg are the labelled citalopram amounts per tablet, not tablets per dose or doses per day. The 20 and 40 mg tablets are scored and the 10 mg tablet is unscored. A score is a product-appearance clue, not permission for anyone to self-split or replace a larger strength with several smaller tablets." }, { "zh": "标签单独提示 60 岁以上、肝功能受损、CYP2C19 慢代谢者或使用西咪替丁/其他 CYP2C19 抑制剂的人需要更严格的专业剂量边界。标签提到 CYP2C19 不等于所有人都需要做全基因筛查；网页也不根据基因结果、年龄或药名替个人选剂量。", "en": "The label sets a stricter professional dosing boundary for people over 60, hepatic impairment, CYP2C19 poor metabolisers or use of cimetidine/another CYP2C19 inhibitor. Mention of CYP2C19 does not mean everyone needs whole-genome screening, and the site does not select an individual's dose from genes, age or a medicine name." }, { "zh": "心律问题、低钾或低镁、利尿药、晕厥/心悸，或药单里还有延长 QT 的药时，应优先让专业人员核对。老年人、使用利尿药或容量不足者还更容易出现低钠；新出现明显乏力、头痛、混乱、步态不稳、跌倒、抽搐或意识变化需要及时医疗评估。", "en": "A heart-rhythm condition, low potassium or magnesium, a diuretic, fainting/palpitations or another QT-prolonging medicine on the list requires priority professional review. Older adults, people taking diuretics or those who are volume depleted also have greater hyponatraemia risk. New marked weakness, headache, confusion, unsteady gait, falls, seizures or altered awareness needs timely medical assessment." }, { "zh": "MAOI、匹莫齐特、其他影响血清素的药、阿司匹林/NSAID、抗血小板药、华法林或其他抗凝药都属于完整药单核对重点。发热伴激越、震颤、肌肉僵硬、腹泻或意识变化，严重出血，呼吸困难，昏厥，或自伤/自杀想法需要立即使用当地急救或危机支持。", "en": "MAOIs, pimozide, other serotonergic medicines, aspirin/NSAIDs, antiplatelets, warfarin and other anticoagulants are priority full-list checks. Fever with agitation, tremor, muscle rigidity, diarrhoea or altered awareness, severe bleeding, breathing difficulty, fainting, or thoughts of self-harm/suicide requires immediate local emergency or crisis support." }, { "zh": "不要因感觉好转、不舒服、漏服或担心副作用就自行骤停、轮换 CELEXA 与 LEXAPRO、ZOLOFT、PROZAC、PAXIL 等同类药，或把两种药叠加。标签要求停药过程由专业人员逐步安排；网页不会生成个人减量表。", "en": "Do not abruptly self-stop, rotate CELEXA with LEXAPRO, ZOLOFT, PROZAC, PAXIL or another related medicine, or combine them because you feel better, unwell, missed a dose or fear a side effect. The label places discontinuation under gradual professional management; the site does not generate an individual taper." } ], "source": { "id": "src_90be49e2ccf8797e", "label": "DailyMed（NLM）：CELEXA 西酞普兰口服片当前美国公开标签与 Medication Guide（SPL v40；2023-10-09 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=4259d9b1-de34-43a4-85a8-41dd214e9177", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "西酞普兰怎样起作用：抑制血清素再摄取，不等于可以和其他 SSRI 自行替换", "en": "How citalopram works: serotonin-reuptake inhibition does not make SSRIs self-interchangeable" }, "summary": { "zh": "当前标签把西酞普兰描述为选择性血清素再摄取抑制剂（SSRI），通过增强中枢血清素活动来理解其药理作用。西酞普兰是外消旋混合物，其中 S-对映体与主要再摄取抑制作用相关；这只能解释药理关系，不能据此把 CELEXA 与只含艾司西酞普兰的 LEXAPRO 按毫克换算、同服或替换。", "en": "The current label describes citalopram as a selective serotonin reuptake inhibitor (SSRI), with its pharmacology understood through enhanced central serotonergic activity. Citalopram is a racemic mixture and the S-enantiomer is associated with most reuptake inhibition. This explains a pharmacologic relationship only; it does not permit milligram conversion, co-use or substitution between CELEXA and LEXAPRO, which contains escitalopram." }, "checks": [ { "zh": "作用机制不是个人疗效预测器。症状、既往反应、其他疾病、心电图、电解质、肝功能、年龄和完整药单都会影响专业判断；网页不会根据一个机制词替个人选药。", "en": "A mechanism is not an individual outcome predictor. Symptoms, previous response, other conditions, ECG, electrolytes, liver function, age and the complete medicine list can affect professional judgement. The site does not select a medicine from a mechanism term." }, { "zh": "同属 SSRI 或商品名相近，不表示可以轮换、叠加、共用剩药或按 mg 一比一换算。药盒上的品牌、通用名、每片强度、剂型、目标市场与处方必须一起核对。", "en": "A shared SSRI class or similar brand wording does not permit rotation, combination, sharing leftovers or one-for-one milligram conversion. Check the brand, generic name, strength per tablet, dosage form, target market and prescription together." }, { "zh": "全基因筛查不是本页给出的普遍前置要求。若开方团队认为 CYP2C19、心电图、电解质或其他检测会改变个人决策，应由其结合准确药品和临床情况解释检测范围与结果。", "en": "Whole-genome screening is not a universal prerequisite stated by this page. If the treating team believes CYP2C19, ECG, electrolytes or another test may change an individual decision, that team should explain the scope and result in the context of the exact medicine and clinical situation." } ], "source": { "id": "src_90be49e2ccf8797e", "label": "DailyMed（NLM）：CELEXA 西酞普兰口服片当前美国公开标签与 Medication Guide（SPL v40；2023-10-09 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=4259d9b1-de34-43a4-85a8-41dd214e9177", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "CELEXA", "generic": "西酞普兰", "dosageFormClass": "西酞普兰口服薄膜衣片：每片 10 mg、20 mg 或 40 mg；分别记录三种 100 片瓶装和两种 100 片单位剂量纸盒身份" }, "labelSource": { "id": "src_90be49e2ccf8797e", "label": "DailyMed（NLM）：CELEXA 西酞普兰口服片当前美国公开标签与 Medication Guide（SPL v40；2023-10-09 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=4259d9b1-de34-43a4-85a8-41dd214e9177", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "productRoutes": [ { "source": { "id": "src_90be49e2ccf8797e", "label": "DailyMed（NLM）：CELEXA 西酞普兰口服片当前美国公开标签与 Medication Guide（SPL v40；2023-10-09 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=4259d9b1-de34-43a4-85a8-41dd214e9177", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-30", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-30", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "CELEXA 是西酞普兰口服薄膜衣片的美国品牌档案。当前标签列出 10、20、40 mg 三种每片强度、五种外层包装身份和完整 Medication Guide。本页优先解释每片 mg、刻痕、老年与 CYP2C19 边界、QT/低钠、同类药与多药联用；不会把标签数字变成个人片数，也不会指导自行掰片、换药或停药。", "history": "DailyMed 当前标签列出 CELEXA 的美国初始批准年份为 1998，SPL v40 于 2023-10-09 生效。本档案只记录当前美国口服片；口服液、通用药、LEXAPRO／艾司西酞普兰及其他市场产品必须分别核对。", "sourceDocuments": [ { "id": "src_90be49e2ccf8797e", "label": "DailyMed（NLM）：CELEXA 西酞普兰口服片当前美国公开标签与 Medication Guide（SPL v40；2023-10-09 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=4259d9b1-de34-43a4-85a8-41dd214e9177", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, { "id": "src_7a71411a51d03fce", "label": "FDA Drugs@FDA：CELEXA（citalopram）NDA 020822 申请与标签记录", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=020822", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_database_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" } ], "applicationNumber": "FDA NDA 020822（CELEXA / citalopram oral tablets）", "approvalTimeline": [ { "date": "1998-01-01", "title": { "zh": "美国初始批准年份", "en": "Initial U.S. approval year" }, "detail": { "zh": "DailyMed 当前标签列出 Initial U.S. Approval: 1998。这里只记录年份，不推定首批包装、其他市场状态或当前供应。", "en": "The current DailyMed label states Initial U.S. Approval: 1998. This records the year only and does not infer the first pack, another market's status or current supply." }, "source": { "id": "src_90be49e2ccf8797e", "label": "DailyMed（NLM）：CELEXA 西酞普兰口服片当前美国公开标签与 Medication Guide（SPL v40；2023-10-09 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=4259d9b1-de34-43a4-85a8-41dd214e9177", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" } }, { "date": "2023-10-09", "title": { "zh": "当前 DailyMed SPL v40 生效", "en": "Current DailyMed SPL v40 became effective" }, "detail": { "zh": "当前标签有效日期为 2023-10-09，并附 FDA 批准的 Medication Guide。日期定位文件版本，不是任何人的开始、停药或换药日期。", "en": "The current label has an effective date of 9 Oct 2023 and includes the FDA-approved Medication Guide. The date identifies the file version, not anyone's start, stopping or switching date." }, "source": { "id": "src_90be49e2ccf8797e", "label": "DailyMed（NLM）：CELEXA 西酞普兰口服片当前美国公开标签与 Medication Guide（SPL v40；2023-10-09 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=4259d9b1-de34-43a4-85a8-41dd214e9177", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "已链接当前品牌片剂标签、Medication Guide、五个外层包装身份和三个官方瓶装面板", "en": "Current brand-tablet label, Medication Guide, five outer-pack identities and three official bottle panels linked" }, "detail": { "zh": "本页记录 10、20、40 mg 的每片标示量、NDC、颜色、刻字、刻痕和包装数量。标签存在不等于任何地点有库存、可购买、适合个人或可以自行换规格。", "en": "The dossier records the per-tablet amount, NDC, colour, imprint, score and pack count for 10, 20 and 40 mg. A label does not establish local stock, purchase availability, individual suitability or self-switching between strengths." } }, { "market": { "zh": "中国大陆、欧盟、日本及其他市场", "en": "Mainland China, EU, Japan and other markets" }, "status": { "zh": "待逐项建立现行市场记录", "en": "Current market record not established" }, "detail": { "zh": "不从美国品牌、NDA、通用名、包装面板或共同药理类别推定当地商品名、批准、包装、供应、可售资格、原研/仿制关系或可替代性。", "en": "No local trade name, approval, packaging, supply, sale eligibility, originator/generic relationship or interchangeability is inferred from the U.S. brand, NDA, generic name, package panel or shared pharmacologic class." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "CELEXA 20 mg 有刻痕，可以自己掰半当 10 mg 吗？", "en": "CELEXA 20 mg is scored. Can I split it myself to make 10 mg?" }, "answer": { "zh": "不要仅凭刻痕自行决定。刻痕是准确片剂的外观身份之一，不会自动证明掰后剂量、稳定性、个人处方和停换药过程都合适；请让药师或开方团队核对准确药盒、处方与目的。", "en": "Do not decide from the score alone. It is an appearance feature of the exact tablet and does not automatically establish post-split amount, stability, prescription suitability or a stopping/switching process. Ask a pharmacist or prescriber to check the exact pack, prescription and purpose." } }, { "question": { "zh": "CELEXA 与 LEXAPRO 名字和机制接近，可以按毫克换吗？", "en": "CELEXA and LEXAPRO have related names and mechanisms. Can their milligrams be converted?" }, "answer": { "zh": "不能从名字、机制或毫克数自行换算。CELEXA 是西酞普兰，LEXAPRO 是艾司西酞普兰；产品、标签、强度体系和个人边界不同，停换药必须由负责治疗的专业人员安排。", "en": "Not from names, mechanism or milligram figures. CELEXA is citalopram and LEXAPRO is escitalopram. Their products, labels, strength systems and individual boundaries differ, and the treating professional must arrange any stopping or switching." } }, { "question": { "zh": "说明书写 CYP2C19，是不是每个人都要做全基因筛查？", "en": "The label mentions CYP2C19. Does everyone need whole-genome screening?" }, "answer": { "zh": "当前标签没有把全基因筛查写成所有人的普遍前置要求。它指出 CYP2C19 慢代谢状态及某些抑制剂会影响专业剂量边界；是否需要何种检测，应由开方团队结合准确药品、年龄、肝功能、同服药和其他临床资料解释。", "en": "The current label does not state whole-genome screening as a universal prerequisite. It identifies CYP2C19 poor-metaboliser status and certain inhibitors as professional dosing boundaries. The prescribing team should explain whether any testing is needed using the exact medicine, age, liver function, co-medications and other clinical information." } }, { "question": { "zh": "老人服用后出现混乱、走路不稳或跌倒怎么办？", "en": "What if an older adult develops confusion, unsteady walking or a fall?" }, "answer": { "zh": "应及时联系当地医疗服务并携带全部药盒和完整药单。标签提示老年人、利尿药使用者或容量不足者低钠风险更高；网页不能判断具体原因，也不要自行骤停或补服。若伴抽搐、昏厥、严重心悸、意识变化或自伤想法，应立即使用当地急救或危机支持。", "en": "Contact local medical services promptly and take every pack and the complete medicine list. The label notes greater hyponatraemia risk in older adults, diuretic users or volume depletion. The site cannot diagnose the cause, and the medicine should not be abruptly self-stopped or made up. Seizure, fainting, severe palpitations, altered awareness or self-harm thoughts requires immediate local emergency or crisis support." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "family-medicine-list-for-pharmacist", "how-to-read-a-drug-label", "dosage-forms-are-part-of-medicine-identity" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/celexa/", "en": "https://origindrug.com/en/drugs/celexa/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "seroquel-xr", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-30", "status": "published_traceable_archive" }, "names": { "brand": "SEROQUEL XR", "generic": "富马酸喹硫平缓释片", "aliases": [ "Seroquel XR", "quetiapine extended release", "quetiapine XR", "quetiapine fumarate extended-release tablets", "富马酸喹硫平缓释片", "喹硫平缓释片", "思瑞康缓释片", "NDA 022047", "61269-270-60", "61269-271-60", "61269-272-60", "61269-273-60", "61269-274-60", "XR 50", "XR 150", "XR 200", "XR 300", "XR 400" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "精神健康", "sourceArchiveMarket": "美国 SEROQUEL XR 当前公开品牌标签（DailyMed SPL v50；2026-04-10 更新；五种 60 片瓶装；NDA 022047）", "dosageFormClass": "口服薄膜衣缓释片：50 mg、150 mg、200 mg、300 mg、400 mg；五种强度均为独立 60 片瓶装身份；不与 SEROQUEL 普通片或通用喹硫平缓释片合并", "dosageFormClassCode": "oral_modified_release", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "2007（FDA NDA 022047 产品批准历程）", "archiveSponsorText": "AstraZeneca（NDA 022047 原申请方）；CHEPLAPHARM / H2-Pharma（当前美国公开标签许可与分销信息）" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [ "SEROQUEL immediate-release tablets", "SEROQUEL 普通片", "quetiapine immediate release", "喹硫平普通片", "generic quetiapine extended-release tablets", "quetiapine oral solution" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-seroquel-xr-quetiapine-extended-release-50mg-60-bottle-ndc-6126927060", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（SPL v50；2026-04-10 更新；2026-04-13 发布）", "en": "Current U.S. DailyMed public label (SPL v50; updated 10 Apr and published 13 Apr 2026)" }, "dosageForm": { "zh": "SEROQUEL XR 喹硫平口服缓释薄膜衣片", "en": "SEROQUEL XR quetiapine oral film-coated extended-release tablet" }, "route": { "zh": "口服；缓释片按当前标签应整片吞服，不得掰开、咀嚼或压碎", "en": "oral; current label says swallow the extended-release tablet whole and do not split, chew or crush" }, "routeCodes": [ "oral" ], "productCode": "NDC 61269-270-60", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片喹硫平 50 mg；60 片瓶装", "en": "Quetiapine 50 mg per tablet; 60-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=NDC61269-270-60.jpg&setid=ab959a35-d0ba-4f18-8f2e-6619d88b16e3", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "喹硫平（以富马酸喹硫平提供）", "en": "quetiapine (supplied as quetiapine fumarate)" }, "value": 50, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片以喹硫平计的标签标示量；不是个人片数、服用时间、分割、转换或停药指令", "en": "labelled quetiapine amount per tablet; not an individual's tablet count, timing, splitting, conversion or stopping instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 60, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-30", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 60, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "桃色", "en": "peach" }, "shape": { "zh": "胶囊形、双凸、薄膜衣缓释片；无刻痕", "en": "capsule-shaped, biconvex, film-coated extended-release tablet; unscored" }, "imprint": "XR 50", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_9062d58ec795b63a", "label": "DailyMed（NLM）：SEROQUEL XR 50 mg、NDC 61269-270-60、60 片瓶装当前美国标签面板", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ab959a35-d0ba-4f18-8f2e-6619d88b16e3", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-seroquel-xr-quetiapine-extended-release-150mg-60-bottle-ndc-6126927160", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（SPL v50；2026-04-10 更新；2026-04-13 发布）", "en": "Current U.S. DailyMed public label (SPL v50; updated 10 Apr and published 13 Apr 2026)" }, "dosageForm": { "zh": "SEROQUEL XR 喹硫平口服缓释薄膜衣片", "en": "SEROQUEL XR quetiapine oral film-coated extended-release tablet" }, "route": { "zh": "口服；缓释片按当前标签应整片吞服，不得掰开、咀嚼或压碎", "en": "oral; current label says swallow the extended-release tablet whole and do not split, chew or crush" }, "routeCodes": [ "oral" ], "productCode": "NDC 61269-271-60", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片喹硫平 150 mg；60 片瓶装", "en": "Quetiapine 150 mg per tablet; 60-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=NDC61269-271-60.jpg&setid=ab959a35-d0ba-4f18-8f2e-6619d88b16e3", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "喹硫平（以富马酸喹硫平提供）", "en": "quetiapine (supplied as quetiapine fumarate)" }, "value": 150, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片以喹硫平计的标签标示量；不是个人片数、服用时间、分割、转换或停药指令", "en": "labelled quetiapine amount per tablet; not an individual's tablet count, timing, splitting, conversion or stopping instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 60, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-30", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 60, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "白色", "en": "white" }, "shape": { "zh": "胶囊形、双凸、薄膜衣缓释片；无刻痕", "en": "capsule-shaped, biconvex, film-coated extended-release tablet; unscored" }, "imprint": "XR 150", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_9062d58ec795b63a", "label": "DailyMed（NLM）：SEROQUEL XR 150 mg、NDC 61269-271-60、60 片瓶装当前美国标签面板", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ab959a35-d0ba-4f18-8f2e-6619d88b16e3", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-seroquel-xr-quetiapine-extended-release-200mg-60-bottle-ndc-6126927260", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（SPL v50；2026-04-10 更新；2026-04-13 发布）", "en": "Current U.S. DailyMed public label (SPL v50; updated 10 Apr and published 13 Apr 2026)" }, "dosageForm": { "zh": "SEROQUEL XR 喹硫平口服缓释薄膜衣片", "en": "SEROQUEL XR quetiapine oral film-coated extended-release tablet" }, "route": { "zh": "口服；缓释片按当前标签应整片吞服，不得掰开、咀嚼或压碎", "en": "oral; current label says swallow the extended-release tablet whole and do not split, chew or crush" }, "routeCodes": [ "oral" ], "productCode": "NDC 61269-272-60", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片喹硫平 200 mg；60 片瓶装", "en": "Quetiapine 200 mg per tablet; 60-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=NDC61269-272-60.jpg&setid=ab959a35-d0ba-4f18-8f2e-6619d88b16e3", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "喹硫平（以富马酸喹硫平提供）", "en": "quetiapine (supplied as quetiapine fumarate)" }, "value": 200, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片以喹硫平计的标签标示量；不是个人片数、服用时间、分割、转换或停药指令", "en": "labelled quetiapine amount per tablet; not an individual's tablet count, timing, splitting, conversion or stopping instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 60, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-30", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 60, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "黄色", "en": "yellow" }, "shape": { "zh": "胶囊形、双凸、薄膜衣缓释片；无刻痕", "en": "capsule-shaped, biconvex, film-coated extended-release tablet; unscored" }, "imprint": "XR 200", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_9062d58ec795b63a", "label": "DailyMed（NLM）：SEROQUEL XR 200 mg、NDC 61269-272-60、60 片瓶装当前美国标签面板", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ab959a35-d0ba-4f18-8f2e-6619d88b16e3", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-seroquel-xr-quetiapine-extended-release-300mg-60-bottle-ndc-6126927360", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（SPL v50；2026-04-10 更新；2026-04-13 发布）", "en": "Current U.S. DailyMed public label (SPL v50; updated 10 Apr and published 13 Apr 2026)" }, "dosageForm": { "zh": "SEROQUEL XR 喹硫平口服缓释薄膜衣片", "en": "SEROQUEL XR quetiapine oral film-coated extended-release tablet" }, "route": { "zh": "口服；缓释片按当前标签应整片吞服，不得掰开、咀嚼或压碎", "en": "oral; current label says swallow the extended-release tablet whole and do not split, chew or crush" }, "routeCodes": [ "oral" ], "productCode": "NDC 61269-273-60", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片喹硫平 300 mg；60 片瓶装", "en": "Quetiapine 300 mg per tablet; 60-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=NDC61269-273-60.jpg&setid=ab959a35-d0ba-4f18-8f2e-6619d88b16e3", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "喹硫平（以富马酸喹硫平提供）", "en": "quetiapine (supplied as quetiapine fumarate)" }, "value": 300, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片以喹硫平计的标签标示量；不是个人片数、服用时间、分割、转换或停药指令", "en": "labelled quetiapine amount per tablet; not an individual's tablet count, timing, splitting, conversion or stopping instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 60, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-30", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 60, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "浅黄色", "en": "pale yellow" }, "shape": { "zh": "胶囊形、双凸、薄膜衣缓释片；无刻痕", "en": "capsule-shaped, biconvex, film-coated extended-release tablet; unscored" }, "imprint": "XR 300", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_9062d58ec795b63a", "label": "DailyMed（NLM）：SEROQUEL XR 300 mg、NDC 61269-273-60、60 片瓶装当前美国标签面板", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ab959a35-d0ba-4f18-8f2e-6619d88b16e3", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-seroquel-xr-quetiapine-extended-release-400mg-60-bottle-ndc-6126927460", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（SPL v50；2026-04-10 更新；2026-04-13 发布）", "en": "Current U.S. DailyMed public label (SPL v50; updated 10 Apr and published 13 Apr 2026)" }, "dosageForm": { "zh": "SEROQUEL XR 喹硫平口服缓释薄膜衣片", "en": "SEROQUEL XR quetiapine oral film-coated extended-release tablet" }, "route": { "zh": "口服；缓释片按当前标签应整片吞服，不得掰开、咀嚼或压碎", "en": "oral; current label says swallow the extended-release tablet whole and do not split, chew or crush" }, "routeCodes": [ "oral" ], "productCode": "NDC 61269-274-60", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片喹硫平 400 mg；60 片瓶装", "en": "Quetiapine 400 mg per tablet; 60-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=NDC61269-274-60.jpg&setid=ab959a35-d0ba-4f18-8f2e-6619d88b16e3", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "喹硫平（以富马酸喹硫平提供）", "en": "quetiapine (supplied as quetiapine fumarate)" }, "value": 400, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片以喹硫平计的标签标示量；不是个人片数、服用时间、分割、转换或停药指令", "en": "labelled quetiapine amount per tablet; not an individual's tablet count, timing, splitting, conversion or stopping instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 60, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-30", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 60, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "白色", "en": "white" }, "shape": { "zh": "胶囊形、双凸、薄膜衣缓释片；无刻痕", "en": "capsule-shaped, biconvex, film-coated extended-release tablet; unscored" }, "imprint": "XR 400", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_9062d58ec795b63a", "label": "DailyMed（NLM）：SEROQUEL XR 400 mg、NDC 61269-274-60、60 片瓶装当前美国标签面板", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ab959a35-d0ba-4f18-8f2e-6619d88b16e3", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-seroquel-xr-quetiapine-extended-release-200mg-60-bottle-ndc-6126927260", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=NDC61269-272-60.jpg&setid=ab959a35-d0ba-4f18-8f2e-6619d88b16e3", "alt": "SEROQUEL XR 喹硫平缓释片 200 mg、NDC 61269-272-60、60 片瓶装在美国 DailyMed 当前标签中的展示面", "archiveMarket": "美国", "labelVersion": "DailyMed SPL v50（2026-04-10 更新；2026-04-13 发布）", "presentation": "SEROQUEL XR 200 mg、NDC 61269-272-60、60 片瓶装标签展示面", "notice": "此图只对应当前美国标签中的 SEROQUEL XR 200 mg、NDC 61269-272-60、60 片瓶装。另四个强度各有独立包装卡；图片不代表 SEROQUEL 普通片、通用喹硫平缓释片、其他市场、库存或可购买资格，不用于鉴定真伪，也不生成个人片数、分片或转换方案。", "source": { "id": "src_9062d58ec795b63a", "label": "DailyMed（NLM）：SEROQUEL XR 喹硫平缓释片当前美国公开标签、Medication Guide 与五个包装面板（SPL v50；2026-04-10 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ab959a35-d0ba-4f18-8f2e-6619d88b16e3", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "SEROQUEL XR 说明书放大阅读：XR、每片 mg 与整片吞服必须一起看", "en": "SEROQUEL XR label reading: read XR, mg per tablet and the swallow-whole rule together" }, "summary": { "zh": "“XR”表示缓释剂型身份，不只是商品名后缀。当前标签要求整片吞服，不得掰开、咀嚼或压碎，以免破坏缓释结构；这条规则不能反过来替任何人选择强度、片数、服用时间、与普通片的换算或停换药步骤。", "en": "“XR” identifies an extended-release dosage form, not merely a brand suffix. The current label says swallow the tablet whole and do not split, chew or crush it, so the extended-release structure is not damaged. That rule cannot select anyone's strength, tablet count, timing, conversion from immediate-release tablets or stopping/switching steps." }, "checks": [ { "zh": "50、150、200、300、400 mg 是每片以喹硫平计的标签标示量，不是今天应服几片或一天几次。五个 NDC 都是 60 片瓶装，但强度、颜色和刻字不同；先核对完整商品名、XR、每片 mg、NDC 和实际药盒。", "en": "50, 150, 200, 300 and 400 mg are labelled quetiapine amounts per tablet, not today's tablet count or frequency. All five NDCs are 60-tablet bottles, but strength, colour and imprint differ. Check the full brand, XR, mg per tablet, NDC and actual pack together." }, { "zh": "SEROQUEL 普通片与 SEROQUEL XR 共享喹硫平成分和品牌家族，却具有不同释放方式。不要自行用普通片替代 XR、把 XR 改成普通片、按毫克一比一换算、隔天轮换、叠加，或因片太大而掰开、压碎、咀嚼。", "en": "SEROQUEL immediate-release tablets and SEROQUEL XR share quetiapine and a brand family but have different release characteristics. Do not self-replace XR with immediate tablets, change immediate to XR, convert milligram-for-milligram, alternate days, combine, split, crush or chew a tablet because it is large." }, { "zh": "当前美国标签带有痴呆相关精神病老年患者死亡风险黑框警示，并明确该产品未获批用于这一人群。高龄、认知变化、嗜睡、头晕、体位性低血压、晕厥、跌倒、吞咽困难或多药并用时，应尽快让当地开方团队或药师核对准确药盒和完整药单。", "en": "The current U.S. label carries a boxed warning about increased mortality in elderly patients with dementia-related psychosis and states that the product is not approved for that population. Older age, cognitive change, drowsiness, dizziness, orthostatic hypotension, fainting, falls, swallowing difficulty or polypharmacy warrants prompt review of the exact pack and complete medicine list by the local prescriber or pharmacist." }, { "zh": "标签把强 CYP3A4 抑制剂或诱导剂、其他中枢作用药、酒精，以及可能加重低血压、嗜睡或跌倒风险的产品列为专业核对重点。网页不能据药名判断能否同用或怎样错开；处方药、非处方药、草药、补充剂都应一起列出。", "en": "The label makes strong CYP3A4 inhibitors or inducers, other centrally acting medicines, alcohol and products that may add to hypotension, drowsiness or fall risk priority professional checks. A website cannot decide co-use or spacing from names; list prescription medicines, non-prescription medicines, herbs and supplements together." }, { "zh": "明显意识或行为改变、自伤/自杀想法、昏厥、跌倒伴受伤、严重过敏样反应、持续高热伴肌强直、抽搐、心悸/胸部不适或其他急性严重问题，需要立即使用当地急救或危机支持，不要等待网页判断是否暂停、补服或换药。", "en": "Marked mental or behavioural change, thoughts of self-harm/suicide, fainting, a fall with injury, a severe allergy-like reaction, persistent fever with muscle rigidity, seizure, palpitations/chest discomfort or another acute serious concern requires immediate local emergency or crisis support. Do not wait for a webpage to decide interruption, make-up use or switching." } ], "source": { "id": "src_9062d58ec795b63a", "label": "DailyMed（NLM）：SEROQUEL XR 喹硫平缓释片当前美国公开标签、Medication Guide 与五个包装面板（SPL v50；2026-04-10 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ab959a35-d0ba-4f18-8f2e-6619d88b16e3", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "喹硫平缓释片怎样起作用：标签描述受体作用，但完整治疗机制仍未确定", "en": "How quetiapine extended release works: the label describes receptor activity while the full therapeutic mechanism remains unknown" }, "summary": { "zh": "当前标签说明，SEROQUEL XR 在所列适应症中的完整作用机制尚未确定；其药理作用可能涉及多巴胺 D2 与血清素 5HT2A 受体拮抗。缓释设计改变药物释放过程，但受体描述和 XR 结构都不能预测某个人是否适合、效果如何、该选多少 mg，或能否与另一种精神科药同用。", "en": "The current label says the full mechanism of SEROQUEL XR in its listed indications is unknown; pharmacologic activity may involve dopamine D2 and serotonin 5HT2A receptor antagonism. The extended-release design changes the release process, but neither the receptor description nor XR structure predicts individual suitability, response, strength or co-use with another psychiatric medicine." }, "checks": [ { "zh": "“作用于多巴胺和血清素受体”是理解药理类别的线索，不是从失眠、情绪、幻觉、焦虑或行为变化自行诊断、选药或加减量的工具。", "en": "“Acts at dopamine and serotonin receptors” is a pharmacology clue, not a tool for self-diagnosing, choosing or adjusting medicine from insomnia, mood, hallucinations, anxiety or behavioural change." }, { "zh": "缓释片与普通片含相同活性成分，不表示释放曲线、辅料、服用条件、暴露过程或标签边界相同。当前标签列出的缓释片辅料包括乳糖、微晶纤维素、枸橼酸钠、羟丙甲纤维素和硬脂酸镁等；辅料差异也不能单独证明疗效更好或更差。", "en": "An extended-release and immediate-release tablet may share the active ingredient without sharing a release profile, excipients, administration conditions, exposure pattern or label boundary. The current label lists lactose, microcrystalline cellulose, sodium citrate, hypromellose and magnesium stearate among the extended-release tablet excipients. An excipient difference alone does not establish better or worse effectiveness." }, { "zh": "同类抗精神病药、相近受体作用或共同导致困倦，都不支持自行叠加、轮换、替换或按 mg 换算。基因筛查也不是网页给所有人的默认答案；需要何种检查应由负责团队结合诊断、肝肾功能、既往反应和完整药单判断。", "en": "A shared antipsychotic class, related receptor activity or common potential for drowsiness does not support self-combination, alternation, substitution or milligram conversion. Genetic testing is not the site's default answer for everyone; the treating team should decide whether any test is relevant using diagnosis, liver/kidney function, prior response and the complete medicine list." } ], "source": { "id": "src_9062d58ec795b63a", "label": "DailyMed（NLM）：SEROQUEL XR 喹硫平缓释片当前美国公开标签、Medication Guide 与五个包装面板（SPL v50；2026-04-10 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ab959a35-d0ba-4f18-8f2e-6619d88b16e3", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "SEROQUEL XR", "generic": "富马酸喹硫平缓释片", "dosageFormClass": "口服薄膜衣缓释片：50 mg、150 mg、200 mg、300 mg、400 mg；五种强度均为独立 60 片瓶装身份；不与 SEROQUEL 普通片或通用喹硫平缓释片合并" }, "labelSource": { "id": "src_9062d58ec795b63a", "label": "DailyMed（NLM）：SEROQUEL XR 喹硫平缓释片当前美国公开标签、Medication Guide 与五个包装面板（SPL v50；2026-04-10 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ab959a35-d0ba-4f18-8f2e-6619d88b16e3", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "productRoutes": [ { "source": { "id": "src_9062d58ec795b63a", "label": "DailyMed（NLM）：SEROQUEL XR 喹硫平缓释片当前美国公开标签、Medication Guide 与五个包装面板（SPL v50；2026-04-10 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ab959a35-d0ba-4f18-8f2e-6619d88b16e3", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-30", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-30", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "SEROQUEL XR 是喹硫平缓释片的美国品牌档案。当前标签列出 50、150、200、300、400 mg 五种每片强度和五个 60 片瓶装，并要求整片吞服，不得掰开、咀嚼或压碎。页面帮助核对 XR、每片 mg、准确包装、缓释结构、老人跌倒/低血压/嗜睡和多药联用线索；不提供个人片数、服用时间、漏用补救、普通片与缓释片换算或停换药方案。", "history": "FDA 的 NDA 022047 审评记录可追溯 SEROQUEL XR 在 2007 年的产品批准历程，原申请方为 AstraZeneca。当前 DailyMed SPL v50 于 2026-04-10 更新、2026-04-13 发布，并列 CHEPLAPHARM 为许可方、H2-Pharma 为美国分销方。品牌历史、当前标签主体、准确 NDC 与目标市场应分别核对。", "sourceDocuments": [ { "id": "src_9062d58ec795b63a", "label": "DailyMed（NLM）：SEROQUEL XR 喹硫平缓释片当前美国公开标签、Medication Guide 与五个包装面板（SPL v50；2026-04-10 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ab959a35-d0ba-4f18-8f2e-6619d88b16e3", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, { "id": "src_b09c6b3d42429631", "label": "FDA Drugs@FDA：SEROQUEL XR（quetiapine fumarate）NDA 022047 申请记录", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=022047", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_database_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, { "id": "src_53802263a3b7cdf7", "label": "FDA：SEROQUEL XR NDA 022047 临床审评资料（记录 2007 年产品批准历程）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022047Orig1s006s007s008MedR.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "regulatory_review", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" } ], "applicationNumber": "FDA NDA 022047（SEROQUEL XR / quetiapine fumarate extended-release tablets）", "approvalTimeline": [ { "date": "2007-05-17", "title": { "zh": "SEROQUEL XR 美国产品批准历程", "en": "U.S. SEROQUEL XR product approval history" }, "detail": { "zh": "FDA 审评资料记录 SEROQUEL XR 缓释片在 2007 年的产品批准历程；这里记录的是监管历史，不是任何人的开始用药日期。", "en": "FDA review material records the 2007 product-approval history of SEROQUEL XR extended-release tablets. This is regulatory history, not anyone's treatment start date." }, "source": { "id": "src_53802263a3b7cdf7", "label": "FDA：SEROQUEL XR NDA 022047 临床审评资料（记录 2007 年产品批准历程）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022047Orig1s006s007s008MedR.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "regulatory_review", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" } }, { "date": "2026-04-10", "title": { "zh": "当前 DailyMed SPL v50 更新", "en": "Current DailyMed SPL v50 updated" }, "detail": { "zh": "当前公开标签于 2026-04-10 更新、2026-04-13 发布，并保留五个 60 片瓶装面板。标签日期不能推定本地库存或可购买性。", "en": "The current public label was updated 10 Apr and published 13 Apr 2026, retaining five 60-tablet bottle panels. A label date does not establish local stock or purchase availability." }, "source": { "id": "src_9062d58ec795b63a", "label": "DailyMed（NLM）：SEROQUEL XR 喹硫平缓释片当前美国公开标签、Medication Guide 与五个包装面板（SPL v50；2026-04-10 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ab959a35-d0ba-4f18-8f2e-6619d88b16e3", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "已链接当前品牌标签、Medication Guide、NDA 记录和五种准确瓶装", "en": "Current brand label, Medication Guide, NDA record and five exact bottles linked" }, "detail": { "zh": "每个包装卡只代表自身强度、NDC、颜色、刻字和 60 片瓶装；不代表供应、个人适用性、真伪或与其他喹硫平产品可互换。", "en": "Each pack card represents only its strength, NDC, colour, imprint and 60-tablet bottle; it does not establish supply, individual suitability, authenticity or interchangeability with another quetiapine product." } }, { "market": { "zh": "中国大陆、欧盟、日本及其他市场", "en": "Mainland China, EU, Japan and other markets" }, "status": { "zh": "待逐项建立现行市场记录", "en": "Current market records not yet established" }, "detail": { "zh": "不从美国品牌、NDA、共同成分或包装推定当地商品名、批准、规格、持有人、供应、原研/仿制关系或可替代性。", "en": "No local trade name, approval, strength, holder, supply, originator/generic relationship or interchangeability is inferred from the U.S. brand, NDA, shared ingredient or packaging." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "SEROQUEL XR 药片太大，可以掰半、压碎或嚼碎吗？", "en": "Can a large SEROQUEL XR tablet be split, crushed or chewed?" }, "answer": { "zh": "当前标签明确要求整片吞服，不得掰开、咀嚼或压碎。吞咽困难时应带准确药盒联系开方团队或药师讨论合适的产品路径，不要自行破坏缓释结构。", "en": "The current label explicitly says swallow whole and do not split, chew or crush. With swallowing difficulty, take the exact pack to the prescriber or pharmacist to discuss an appropriate product pathway rather than damaging the extended-release structure." } }, { "question": { "zh": "SEROQUEL 普通片与 SEROQUEL XR 的毫克数相同，可以直接互换吗？", "en": "Can SEROQUEL immediate tablets and SEROQUEL XR be directly exchanged when the milligrams match?" }, "answer": { "zh": "不能从共同成分或毫克数自行互换。普通片和 XR 的释放方式、标签与产品身份不同；转换、时间、片数和停药过程必须由负责治疗的专业人员结合准确处方安排。", "en": "Not from a shared ingredient or milligram figure. Immediate and XR tablets have different release characteristics, labels and product identities. The treating professional must arrange any conversion, timing, tablet count or stopping process using the exact prescription." } }, { "question": { "zh": "老人服后嗜睡、站起头晕或跌倒怎么办？", "en": "What if an older adult becomes drowsy, dizzy on standing or falls?" }, "answer": { "zh": "应及时联系当地医疗服务，并带上全部实际药盒和完整药单。昏厥、跌倒伴受伤、明显意识变化、胸部不适或其他严重情况需要立即使用急救支持；不要自行补服、减半或换成普通片。", "en": "Contact local medical services promptly and take every actual pack and the complete medicine list. Fainting, a fall with injury, marked altered awareness, chest discomfort or another serious concern requires immediate emergency support; do not self-make up, halve or change to immediate-release tablets." } }, { "question": { "zh": "同成分仿制缓释片与 SEROQUEL XR 的辅料或释放方式会完全一样吗？", "en": "Will a generic extended-release tablet have exactly the same excipients or release design as SEROQUEL XR?" }, "answer": { "zh": "不能仅凭共同活性成分作此结论。应分别查看目标市场现行标签、辅料、剂型、规格和监管等效性资料；网页不会从商品名或外观推定可替代性，也不会判断哪一盒对个人更好。", "en": "A shared active ingredient alone cannot establish that. Review the current target-market label, excipients, dosage form, strength and regulatory equivalence record separately. The site does not infer interchangeability from a name or appearance or decide which pack is better for an individual." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "dosage-forms-are-part-of-medicine-identity", "family-medicine-list-for-pharmacist", "generic-drugs-and-bioequivalence" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/seroquel-xr/", "en": "https://origindrug.com/en/drugs/seroquel-xr/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "trintellix-vortioxetine", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-30", "status": "published_traceable_archive" }, "names": { "brand": "TRINTELLIX", "generic": "沃替西汀", "aliases": [ "Trintellix", "BRINTELLIX", "Brintellix", "vortioxetine", "vortioxetine hydrobromide", "沃替西汀", "氢溴酸沃替西汀", "沃替西汀片", "心达悦", "TRINTELLIX", "NDA 204447", "64764-720-30", "64764-730-30", "64764-750-30" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "精神健康", "sourceArchiveMarket": "美国 TRINTELLIX 当前品牌片剂标签（5/10/20 mg；三个 30 片瓶装面板；NDA 204447）及欧盟 BRINTELLIX 现行产品资料（5/10/15/20 mg 片剂与 20 mg/mL 口服滴剂）", "dosageFormClass": "美国口服薄膜衣片：5 mg、10 mg、20 mg；欧盟 BRINTELLIX 另列 15 mg 薄膜衣片和 20 mg/mL 口服滴剂。市场、品牌、剂型、每片/每 mL 单位必须分开，不据共同成分换算", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "2013（FDA NDA 204447；欧盟 EMEA/H/C/002717）", "archiveSponsorText": "Takeda（美国 NDA 204447 申请与当前标签销售方）；H. Lundbeck A/S（商标及欧盟持有人）" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [ "BRILINTA", "Brilinta", "ticagrelor", "替格瑞洛", "generic vortioxetine", "vortioxetine oral drops", "沃替西汀口服滴剂" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-trintellix-vortioxetine-5mg-30-bottle-ndc-6476472030", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（SPL v18；2025-03-05 更新；2025-03-11 发布）", "en": "Current U.S. DailyMed public label (SPL v18; updated 5 Mar and published 11 Mar 2025)" }, "dosageForm": { "zh": "TRINTELLIX 沃替西汀口服薄膜衣片", "en": "TRINTELLIX vortioxetine oral film-coated tablet" }, "route": { "zh": "口服；准确片剂身份字段，不从药片外观推定个人用法或能否掰片", "en": "oral; exact tablet-identity field, with no personal-use or splitting inference from appearance" }, "routeCodes": [ "oral" ], "productCode": "NDC 64764-720-30", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片沃替西汀 5 mg；30 片瓶装", "en": "Vortioxetine 5 mg per tablet; 30-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=trintellix-11.jpg&setid=1a5b68e2-14d0-419d-9ec6-1ca97145e838", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "沃替西汀（以氢溴酸沃替西汀提供）", "en": "vortioxetine (supplied as vortioxetine hydrobromide)" }, "value": 5, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片以沃替西汀计的标签标示量；不是个人片数、频率、掰片、停药或换药指令", "en": "labelled vortioxetine amount per tablet; not an individual's tablet count, frequency, splitting, stopping or switching instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-30", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 30, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "粉红色", "en": "pink" }, "shape": { "zh": "杏仁形、双凸、薄膜衣片；无刻痕", "en": "almond-shaped, biconvex, film-coated tablet; unscored" }, "imprint": "5 / TL", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_98bfd4c4a0e4afd8", "label": "DailyMed（NLM）：TRINTELLIX 5 mg、NDC 64764-720-30、30 片瓶装当前美国标签面板", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=1a5b68e2-14d0-419d-9ec6-1ca97145e838", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-trintellix-vortioxetine-10mg-30-bottle-ndc-6476473030", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（SPL v18；2025-03-05 更新；2025-03-11 发布）", "en": "Current U.S. DailyMed public label (SPL v18; updated 5 Mar and published 11 Mar 2025)" }, "dosageForm": { "zh": "TRINTELLIX 沃替西汀口服薄膜衣片", "en": "TRINTELLIX vortioxetine oral film-coated tablet" }, "route": { "zh": "口服；准确片剂身份字段，不从药片外观推定个人用法或能否掰片", "en": "oral; exact tablet-identity field, with no personal-use or splitting inference from appearance" }, "routeCodes": [ "oral" ], "productCode": "NDC 64764-730-30", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片沃替西汀 10 mg；30 片瓶装", "en": "Vortioxetine 10 mg per tablet; 30-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=trintellix-12.jpg&setid=1a5b68e2-14d0-419d-9ec6-1ca97145e838", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "沃替西汀（以氢溴酸沃替西汀提供）", "en": "vortioxetine (supplied as vortioxetine hydrobromide)" }, "value": 10, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片以沃替西汀计的标签标示量；不是个人片数、频率、掰片、停药或换药指令", "en": "labelled vortioxetine amount per tablet; not an individual's tablet count, frequency, splitting, stopping or switching instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-30", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 30, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "黄色", "en": "yellow" }, "shape": { "zh": "杏仁形、双凸、薄膜衣片；无刻痕", "en": "almond-shaped, biconvex, film-coated tablet; unscored" }, "imprint": "10 / TL", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_98bfd4c4a0e4afd8", "label": "DailyMed（NLM）：TRINTELLIX 10 mg、NDC 64764-730-30、30 片瓶装当前美国标签面板", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=1a5b68e2-14d0-419d-9ec6-1ca97145e838", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-trintellix-vortioxetine-20mg-30-bottle-ndc-6476475030", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（SPL v18；2025-03-05 更新；2025-03-11 发布）", "en": "Current U.S. DailyMed public label (SPL v18; updated 5 Mar and published 11 Mar 2025)" }, "dosageForm": { "zh": "TRINTELLIX 沃替西汀口服薄膜衣片", "en": "TRINTELLIX vortioxetine oral film-coated tablet" }, "route": { "zh": "口服；准确片剂身份字段，不从药片外观推定个人用法或能否掰片", "en": "oral; exact tablet-identity field, with no personal-use or splitting inference from appearance" }, "routeCodes": [ "oral" ], "productCode": "NDC 64764-750-30", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片沃替西汀 20 mg；30 片瓶装", "en": "Vortioxetine 20 mg per tablet; 30-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=trintellix-13.jpg&setid=1a5b68e2-14d0-419d-9ec6-1ca97145e838", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "沃替西汀（以氢溴酸沃替西汀提供）", "en": "vortioxetine (supplied as vortioxetine hydrobromide)" }, "value": 20, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片以沃替西汀计的标签标示量；不是个人片数、频率、掰片、停药或换药指令", "en": "labelled vortioxetine amount per tablet; not an individual's tablet count, frequency, splitting, stopping or switching instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-30", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 30, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "红色", "en": "red" }, "shape": { "zh": "杏仁形、双凸、薄膜衣片；无刻痕", "en": "almond-shaped, biconvex, film-coated tablet; unscored" }, "imprint": "20 / TL", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_98bfd4c4a0e4afd8", "label": "DailyMed（NLM）：TRINTELLIX 20 mg、NDC 64764-750-30、30 片瓶装当前美国标签面板", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=1a5b68e2-14d0-419d-9ec6-1ca97145e838", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-trintellix-vortioxetine-10mg-30-bottle-ndc-6476473030", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=trintellix-12.jpg&setid=1a5b68e2-14d0-419d-9ec6-1ca97145e838", "alt": "TRINTELLIX 沃替西汀 10 mg、NDC 64764-730-30、30 片瓶装在美国 DailyMed 当前标签中的展示面", "archiveMarket": "美国", "labelVersion": "DailyMed SPL v18（2025-03-05 更新；2025-03-11 发布）", "presentation": "TRINTELLIX 10 mg、NDC 64764-730-30、30 片瓶装标签展示面", "notice": "此图只对应当前美国标签中的 TRINTELLIX 10 mg、NDC 64764-730-30、30 片瓶装。另两个强度各有独立包装卡；它不代表欧盟 BRINTELLIX 15 mg、口服滴剂、BRILINTA、通用药、其他市场、库存或可购买资格，不用于鉴定真伪，也不生成个人片数或停换药方案。", "source": { "id": "src_98bfd4c4a0e4afd8", "label": "DailyMed（NLM）：TRINTELLIX 沃替西汀口服片当前美国公开标签与 Medication Guide（SPL v18；2025-03-05 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=1a5b68e2-14d0-419d-9ec6-1ca97145e838", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "TRINTELLIX 说明书放大阅读：先分清沃替西汀、BRINTELLIX 与 BRILINTA", "en": "TRINTELLIX label reading: separate vortioxetine, BRINTELLIX and BRILINTA first" }, "summary": { "zh": "美国 TRINTELLIX 与欧盟 BRINTELLIX 都可指向沃替西汀产品，但目标市场、规格和剂型不同；BRILINTA 则是替格瑞洛抗血小板药。名称、每片 mg、剂型、市场与实际药盒必须一起核对，不能只看前几个字母。", "en": "U.S. TRINTELLIX and EU BRINTELLIX can identify vortioxetine products, but their markets, strengths and dosage forms differ. BRILINTA is the antiplatelet medicine ticagrelor. Check the full name, mg per tablet, dosage form, market and actual pack together rather than the first few letters." }, "checks": [ { "zh": "美国 5、10、20 mg 是每片以沃替西汀计的标签标示量，不是一次几片或一天几次。欧盟还列 15 mg 片和 20 mg/mL 口服滴剂；“每片 mg”与“每 mL mg”不是同一单位，不能自行换算或按颜色替代。", "en": "U.S. 5, 10 and 20 mg are labelled vortioxetine amounts per tablet, not tablets per dose or doses per day. The EU also lists a 15 mg tablet and 20 mg/mL oral drops. Mg per tablet and mg per mL are different units and must not be self-converted or substituted by colour." }, { "zh": "不要把 TRINTELLIX／BRINTELLIX 与 BRILINTA 混同。BRILINTA 含替格瑞洛，是抗血小板药；若药单、处方或药盒名称不清，先暂停凭名字自行判断，带实际包装让药师或开方团队核对。", "en": "Do not confuse TRINTELLIX/BRINTELLIX with BRILINTA. BRILINTA contains ticagrelor and is an antiplatelet medicine. If a list, prescription or pack name is unclear, stop guessing from the name and have a pharmacist or prescriber check the actual packaging." }, { "zh": "MAOI、利奈唑胺、静脉亚甲蓝，以及其他影响血清素的抗抑郁药、曲马多、锂剂、丁螺环酮、安非他明、色氨酸或圣约翰草都属于血清素综合征优先核对项。发热伴激越、震颤、肌强直、腹泻、意识变化或抽搐需要立即使用当地急救支持。", "en": "MAOIs, linezolid, intravenous methylene blue and other serotonergic antidepressants, tramadol, lithium, buspirone, amphetamines, tryptophan or St John's wort are priority serotonin-syndrome checks. Fever with agitation, tremor, muscle rigidity, diarrhoea, altered awareness or seizures requires immediate local emergency support." }, { "zh": "阿司匹林、NSAID 止痛药、华法林、抗血小板药或其他抗凝药可能增加出血风险；老年人、使用利尿药或容量不足者还要优先留意低钠。新出现严重出血、明显乏力、头痛、混乱、步态不稳、跌倒、抽搐或意识变化需要及时医疗评估。", "en": "Aspirin, NSAID pain medicines, warfarin, antiplatelets or other anticoagulants may add bleeding risk. Older adults, people taking diuretics or those who are volume depleted also need priority review for hyponatraemia. New severe bleeding, marked weakness, headache, confusion, unsteady gait, falls, seizures or altered awareness needs timely medical assessment." }, { "zh": "强 CYP2D6 抑制剂（如安非他酮、氟西汀、帕罗西汀、奎尼丁）和强酶诱导剂（如利福平、卡马西平、苯妥英）可能影响专业用药安排。标签提到 CYP2D6 不等于每个人都要做全基因筛查；网页不会根据基因、年龄或药名生成个人加减量或停换药表。", "en": "Strong CYP2D6 inhibitors such as bupropion, fluoxetine, paroxetine or quinidine and strong enzyme inducers such as rifampin, carbamazepine or phenytoin may affect professional management. A CYP2D6 label statement does not mean everyone needs whole-genome screening, and the site does not generate an individual dose-change or stopping/switching plan from genes, age or a medicine name." }, { "zh": "症状好转、不舒服、恶心、漏服、担心副作用或出现性功能问题，都不是自行骤停、隔天轮换、叠加另一种抗抑郁药或用剩药替换的依据。自伤/自杀想法、明显行为改变、严重过敏样反应或其他急性严重问题需要立即使用当地急救或危机支持。", "en": "Feeling better, unwell, nauseated, missing a dose, fearing an adverse effect or noticing sexual problems is not a reason to abruptly self-stop, alternate days, add another antidepressant or substitute leftovers. Thoughts of self-harm/suicide, marked behavioural change, a severe allergy-like reaction or another acute serious concern requires immediate local emergency or crisis support." } ], "source": { "id": "src_98bfd4c4a0e4afd8", "label": "DailyMed（NLM）：TRINTELLIX 沃替西汀口服片当前美国公开标签与 Medication Guide（SPL v18；2025-03-05 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=1a5b68e2-14d0-419d-9ec6-1ca97145e838", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "沃替西汀怎样起作用：影响血清素转运体和多种受体，但完整治疗机制仍未确定", "en": "How vortioxetine works: serotonin-transporter and receptor activity without a fully established therapeutic mechanism" }, "summary": { "zh": "当前标签说明，沃替西汀抗抑郁作用的完整机制尚未完全理解；其作用被认为与抑制血清素转运体（5-HT reuptake）并调节多种 5-HT 受体有关。这个“多模式”药理描述不能预测某个人是否适合、是否优于另一种抗抑郁药、该选多少 mg，或能否与其他血清素药叠加。", "en": "The current label says the complete antidepressant mechanism of vortioxetine is not fully understood. Its activity is thought to involve inhibition of the serotonin transporter (5-HT reuptake) and modulation of several 5-HT receptors. This multimodal pharmacology does not predict individual suitability, superiority to another antidepressant, strength choice or safe combination with another serotonergic medicine." }, "checks": [ { "zh": "作用机制是理解药理和相互作用的线索，不是凭症状自行诊断抑郁、选药、加量或停药的工具。既往反应、其他疾病、完整药单、年龄、肝肾情况和专业评估都可能影响个人决策。", "en": "Mechanism is a clue for pharmacology and interaction review, not a tool to self-diagnose depression, choose a medicine, increase a dose or stop treatment from symptoms. Prior response, other conditions, the full medicine list, age, liver/kidney status and professional assessment may all affect an individual decision." }, { "zh": "同属抗抑郁药、都影响血清素或商品名相近，不表示 TRINTELLIX 可以和 CELEXA、LEXAPRO、ZOLOFT、PROZAC、PAXIL、CYMBALTA、EFFEXOR 等按 mg 换算、轮换或叠加。", "en": "Shared antidepressant use, serotonergic activity or similar names do not permit milligram conversion, rotation or combination of TRINTELLIX with CELEXA, LEXAPRO, ZOLOFT, PROZAC, PAXIL, CYMBALTA, EFFEXOR or another product." }, { "zh": "原研与仿制产品可以共享活性成分和监管等效性依据，但辅料、外观与具体包装未必相同。是否可替代必须查目标市场现行批准与处方；不能从颜色、刻字、共同成分或机制自行判断哪一盒更好。", "en": "Originator and generic products can share an active ingredient and regulatory equivalence basis while excipients, appearance and exact packaging may differ. Any substitution must use the current target-market approval and prescription, not colour, imprint, a shared ingredient or mechanism to decide which pack is better." } ], "source": { "id": "src_98bfd4c4a0e4afd8", "label": "DailyMed（NLM）：TRINTELLIX 沃替西汀口服片当前美国公开标签与 Medication Guide（SPL v18；2025-03-05 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=1a5b68e2-14d0-419d-9ec6-1ca97145e838", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "TRINTELLIX", "generic": "沃替西汀", "dosageFormClass": "美国口服薄膜衣片：5 mg、10 mg、20 mg；欧盟 BRINTELLIX 另列 15 mg 薄膜衣片和 20 mg/mL 口服滴剂。市场、品牌、剂型、每片/每 mL 单位必须分开，不据共同成分换算" }, "labelSource": { "id": "src_98bfd4c4a0e4afd8", "label": "DailyMed（NLM）：TRINTELLIX 沃替西汀口服片当前美国公开标签与 Medication Guide（SPL v18；2025-03-05 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=1a5b68e2-14d0-419d-9ec6-1ca97145e838", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "productRoutes": [ { "source": { "id": "src_98bfd4c4a0e4afd8", "label": "DailyMed（NLM）：TRINTELLIX 沃替西汀口服片当前美国公开标签与 Medication Guide（SPL v18；2025-03-05 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=1a5b68e2-14d0-419d-9ec6-1ca97145e838", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-30", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_3a8053007dd9b12c", "label": "EMA：BRINTELLIX 5/10/15/20 mg 片剂与 20 mg/mL 口服滴剂现行产品资料（2026-01-19 更新）", "url": "https://www.ema.europa.eu/en/documents/product-information/brintellix-epar-product-information_en.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "status": "product_level_public_record_verified", "authority": { "zh": "EMA", "en": "EMA" }, "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "recordType": { "zh": "监管产品记录或欧盟产品资料", "en": "Regulatory product record or EU product information" }, "reviewedAt": "2026-08-30", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-30", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "TRINTELLIX 是沃替西汀口服片的美国品牌档案，欧盟同一活性成分品牌名为 BRINTELLIX；它不是名称相近的抗血小板药 BRILINTA。当前美国标签展示 5、10、20 mg 三个 30 片瓶装。本页优先解释每片 mg、跨市场名字、血清素综合征、低钠、出血、停药和 CYP2D6／多药联用边界；不提供个人片数、加减量、停药、换药或基因检测方案。", "history": "FDA 于 2013-09-30 批准 NDA 204447，当时美国品牌名为 BRINTELLIX。FDA 的药物警戒记录指出该名称曾与抗血小板药 BRILINTA 混淆，并于 2016 年批准把美国沃替西汀品牌改名为 TRINTELLIX；欧盟仍使用 BRINTELLIX。名称历史本身不是停换药、叠加或跨市场购买建议。", "sourceDocuments": [ { "id": "src_98bfd4c4a0e4afd8", "label": "DailyMed（NLM）：TRINTELLIX 沃替西汀口服片当前美国公开标签与 Medication Guide（SPL v18；2025-03-05 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=1a5b68e2-14d0-419d-9ec6-1ca97145e838", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, { "id": "src_3823311748fdf53b", "label": "FDA Drugs@FDA：TRINTELLIX / BRINTELLIX（vortioxetine）NDA 204447 申请与标签记录", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=204447", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_database_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, { "id": "src_1c3af9dee460528a", "label": "FDA：BRINTELLIX（vortioxetine）NDA 204447 初始批准函（2013-09-30）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/204447Orig1s000ltr.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "regulatory_decision", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, { "id": "src_591e92aac633ab2e", "label": "FDA：沃替西汀 NDA 204447 临床审评资料（Takeda；5/10/15/20 mg 研发与初始申请记录）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204447orig1s000medr.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "regulatory_review", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, { "id": "src_2ebecd1e029b04ba", "label": "FDA AEMS：BRINTELLIX 与 BRILINTA 名称混淆信号及 2016 年改名 TRINTELLIX 的安全记录", "url": "https://www.fda.gov/drugs/fda-adverse-event-monitoring-system-aems/april-june-2015-potential-signals-serious-risksnew-safety-information-identified-fda-adverse-event", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, { "id": "src_9cbef3a94c720a1d", "label": "EMA：BRINTELLIX（vortioxetine）EPAR 与欧盟现行产品资料入口", "url": "https://www.ema.europa.eu/en/medicines/human/EPAR/brintellix", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_database_record", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, { "id": "src_3a8053007dd9b12c", "label": "EMA：BRINTELLIX 5/10/15/20 mg 片剂与 20 mg/mL 口服滴剂现行产品资料（2026-01-19 更新）", "url": "https://www.ema.europa.eu/en/documents/product-information/brintellix-epar-product-information_en.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" } ], "applicationNumber": "FDA NDA 204447（TRINTELLIX / former U.S. name BRINTELLIX / vortioxetine tablets）；EMA EMEA/H/C/002717（BRINTELLIX）", "approvalTimeline": [ { "date": "2013-09-30", "title": { "zh": "美国 NDA 204447 初始批准", "en": "Initial U.S. NDA 204447 approval" }, "detail": { "zh": "FDA 批准函记录 BRINTELLIX（vortioxetine）5、10、15、20 mg 片用于成人重性抑郁障碍；这里记录初始申请史，不把历史 15 mg 自动写成当前美国展示包装。", "en": "The FDA approval letter records BRINTELLIX (vortioxetine) 5, 10, 15 and 20 mg tablets for adult major depressive disorder. This is initial application history and does not turn historical 15 mg into a current displayed U.S. pack." }, "source": { "id": "src_1c3af9dee460528a", "label": "FDA：BRINTELLIX（vortioxetine）NDA 204447 初始批准函（2013-09-30）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/204447Orig1s000ltr.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "regulatory_decision", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" } }, { "date": "2013-12-18", "title": { "zh": "欧盟 BRINTELLIX 获得上市许可", "en": "EU BRINTELLIX marketing authorisation" }, "detail": { "zh": "EMA EPAR 记录欧盟许可及 H. Lundbeck A/S 持有人；现行产品资料列 5、10、15、20 mg 片和 20 mg/mL 口服滴剂。", "en": "The EMA EPAR records the EU authorisation and H. Lundbeck A/S as holder. Current product information lists 5, 10, 15 and 20 mg tablets and 20 mg/mL oral drops." }, "source": { "id": "src_9cbef3a94c720a1d", "label": "EMA：BRINTELLIX（vortioxetine）EPAR 与欧盟现行产品资料入口", "url": "https://www.ema.europa.eu/en/medicines/human/EPAR/brintellix", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_database_record", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" } }, { "date": "2016-05-01", "title": { "zh": "美国品牌由 BRINTELLIX 改名为 TRINTELLIX", "en": "U.S. brand changed from BRINTELLIX to TRINTELLIX" }, "detail": { "zh": "FDA 药物警戒记录说明改名用于降低与替格瑞洛抗血小板药 BRILINTA 的处方和调配混淆。日期仅定位监管安全行动，不表示个人应换药或更换市场包装。", "en": "The FDA safety record says the change was intended to reduce prescribing and dispensing confusion with the antiplatelet medicine BRILINTA (ticagrelor). The date identifies a regulatory safety action and does not mean an individual should change medicine or market pack." }, "source": { "id": "src_2ebecd1e029b04ba", "label": "FDA AEMS：BRINTELLIX 与 BRILINTA 名称混淆信号及 2016 年改名 TRINTELLIX 的安全记录", "url": "https://www.fda.gov/drugs/fda-adverse-event-monitoring-system-aems/april-june-2015-potential-signals-serious-risksnew-safety-information-identified-fda-adverse-event", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" } }, { "date": "2025-03-05", "title": { "zh": "当前美国 DailyMed SPL v18 更新", "en": "Current U.S. DailyMed SPL v18 updated" }, "detail": { "zh": "当前品牌标签展示 5、10、20 mg 三个 30 片瓶装面板和 Medication Guide。标签存在不能证明本地库存、可购买性或个人适用性。", "en": "The current brand label displays 5, 10 and 20 mg 30-tablet bottle panels and a Medication Guide. A label does not establish local stock, purchase availability or individual suitability." }, "source": { "id": "src_98bfd4c4a0e4afd8", "label": "DailyMed（NLM）：TRINTELLIX 沃替西汀口服片当前美国公开标签与 Medication Guide（SPL v18；2025-03-05 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=1a5b68e2-14d0-419d-9ec6-1ca97145e838", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "已链接 TRINTELLIX 当前品牌标签、Medication Guide、NDA 记录和三个准确 30 片瓶装", "en": "Current TRINTELLIX brand label, Medication Guide, NDA record and three exact 30-tablet bottles linked" }, "detail": { "zh": "本档案只把官方展示面写入产品呈现；其余 7、90、500 片标签 NDC 仍可在原始标签核对，但不在没有独立展示面时虚构包装图。", "en": "Only official display panels are entered as product presentations. Other 7-, 90- and 500-tablet label NDCs remain available in the source label, but no package image is invented without a separate display panel." } }, { "market": { "zh": "欧盟", "en": "European Union" }, "status": { "zh": "已链接 BRINTELLIX EPAR 和现行 5/10/15/20 mg 片剂、20 mg/mL 口服滴剂资料", "en": "BRINTELLIX EPAR and current 5/10/15/20 mg tablets plus 20 mg/mL oral-drops information linked" }, "detail": { "zh": "欧盟产品资料提供多个包装数量；本页先建立市场与剂型边界，不把任何欧盟包装推定为中国大陆或美国包装，也不把滴剂单位换成片数。", "en": "EU product information lists several pack quantities. This page first establishes market and dosage-form boundaries and does not infer that an EU pack is a Mainland-China or U.S. pack or convert drops into tablet counts." } }, { "market": { "zh": "中国大陆、日本及其他市场", "en": "Mainland China, Japan and other markets" }, "status": { "zh": "待逐项建立现行市场记录", "en": "Current market records not yet established" }, "detail": { "zh": "别名“心达悦”只保留为检索线索，不在缺少本轮现行一手记录时推定当地批准、包装、持有人、供应、原研/仿制关系或可替代性。", "en": "The alias “心达悦” is retained only as a search clue. Without a current first-party record in this review, no local approval, pack, holder, supply, originator/generic relationship or interchangeability is inferred." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "BRINTELLIX、TRINTELLIX 和 BRILINTA 是一回事吗？", "en": "Are BRINTELLIX, TRINTELLIX and BRILINTA the same medicine?" }, "answer": { "zh": "不是。TRINTELLIX 是美国现用沃替西汀品牌名，欧盟仍使用 BRINTELLIX；BRILINTA 是替格瑞洛抗血小板药。必须核对完整名称、通用名、市场和实际药盒，不能只看相似拼写。", "en": "No. TRINTELLIX is the current U.S. vortioxetine brand name, while the EU still uses BRINTELLIX. BRILINTA is the antiplatelet medicine ticagrelor. Check the full name, generic, market and actual pack rather than similar spelling." } }, { "question": { "zh": "美国没有展示 15 mg，能用 5 mg 和 10 mg 自己拼成吗？", "en": "The current U.S. panels do not show 15 mg. Can I assemble it from 5 mg and 10 mg myself?" }, "answer": { "zh": "不能从算术或欧盟 15 mg 产品自行安排。当前美国展示面、欧盟产品资料和个人处方是不同层次；任何片数组合、换规格或跨市场替代都必须由负责治疗的专业人员核对。", "en": "Do not arrange that from arithmetic or the EU 15 mg product. Current U.S. display panels, EU product information and an individual prescription are different layers. The treating professional must review any tablet combination, strength change or cross-market substitution." } }, { "question": { "zh": "标签提到 CYP2D6，是不是要先做全基因筛查？", "en": "The label mentions CYP2D6. Does everyone need whole-genome screening first?" }, "answer": { "zh": "标签并没有把全基因筛查设为所有人的统一前提。更常见的第一步是把准确药盒、处方药、非处方药、补充剂、既往反应和相关病史交给开方团队核对；是否需要特定基因检测由专业人员解释。", "en": "The label does not make whole-genome screening a universal prerequisite. A usual first step is to give the prescriber the exact pack, prescription and non-prescription medicines, supplements, prior response and relevant history. A professional should explain whether a specific genetic test is relevant." } }, { "question": { "zh": "能把 TRINTELLIX 与另一种抗抑郁药隔天换着吃吗？", "en": "Can TRINTELLIX be alternated by day with another antidepressant?" }, "answer": { "zh": "不要自行轮换、叠加或骤停。共同影响血清素不表示可交替，且停药反应、血清素综合征和相互作用都需要结合完整药单由开方团队安排。", "en": "Do not self-alternate, combine or abruptly stop. Shared serotonergic activity does not permit rotation, and discontinuation effects, serotonin syndrome and interactions require prescriber management using the full medicine list." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "family-medicine-list-for-pharmacist", "generic-drugs-and-bioequivalence", "dosage-forms-are-part-of-medicine-identity" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/trintellix-vortioxetine/", "en": "https://origindrug.com/en/drugs/trintellix-vortioxetine/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "desyrel-trazodone", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-30", "status": "published_traceable_archive" }, "names": { "brand": "DESYREL / trazodone", "generic": "盐酸曲唑酮", "aliases": [ "DESYREL", "Desyrel", "trazodone", "trazodone hydrochloride", "曲唑酮", "盐酸曲唑酮", "盐酸曲唑酮片", "NDA 018207", "70771-1128-1", "70771-1129-1", "70771-1130-1", "70771-1131-1" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "精神健康", "sourceArchiveMarket": "美国 DESYREL NDA 018207 历史品牌标签与当前盐酸曲唑酮通用药标签；当前展示 50/100/150/300 mg 四种 100 片瓶装。品牌历史、当前通用药、包装与供应状态必须分开。", "dosageFormClass": "口服片：当前展示每片 50 mg、100 mg、150 mg、300 mg 盐酸曲唑酮；不把普通片与任何缓释产品或其他市场产品合并", "dosageFormClassCode": "oral_modified_release", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "1981（美国初始批准）", "archiveSponsorText": "FDA DESYREL NDA 018207 历史品牌记录；Novel Laboratories, Inc. 当前通用药标签" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [ "DESYREL", "trazodone", "trazodone hydrochloride", "盐酸曲唑酮", "盐酸曲唑酮片", "trazodone 50 mg", "trazodone 100 mg", "trazodone 150 mg", "trazodone 300 mg" ], "excludedProductCues": [ "Oleptro", "trazodone extended release", "曲唑酮缓释片", "nefazodone", "奈法唑酮" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-trazodone-hydrochloride-50mg-100-bottle-ndc-7077111281", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国通用药公开标签（2026-01-23 更新）", "en": "Current U.S. generic DailyMed label (updated 23 Jan 2026)" }, "dosageForm": { "zh": "盐酸曲唑酮口服片", "en": "trazodone hydrochloride oral tablet" }, "route": { "zh": "口服（准确产品身份字段）", "en": "oral (exact-product identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 70771-1128-1", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片盐酸曲唑酮 50 mg；100 片瓶装", "en": "50 mg trazodone hydrochloride per tablet; 100-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=0b9d3b91-26ed-477b-a88e-2d6a76fedabf-01.jpg&setid=43d4be17-5fae-4326-a5c4-9e25e2db6a43&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "盐酸曲唑酮", "en": "trazodone hydrochloride" }, "value": 50, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、睡眠用途、掰片、加减量、停药或换药指令", "en": "labelled amount per tablet; not an individual's tablet count, sleep use, splitting, dose change, stopping or switching instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-30", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": null, "shape": { "zh": "片剂外观与刻痕须回到所引当前标签和实际药盒核对；不从包装正面推定能否掰片", "en": "Check tablet appearance and score against the cited current label and actual pack; do not infer splitting from the front panel" }, "imprint": null, "scoreStatus": "verify_exact_current_label_before_splitting", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_c27a916390cb224f", "label": "DailyMed（NLM）：盐酸曲唑酮片当前美国通用药公开标签、Medication Guide 与准确包装面板（2026-01-23 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=43d4be17-5fae-4326-a5c4-9e25e2db6a43&version=8", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-trazodone-hydrochloride-100mg-100-bottle-ndc-7077111291", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国通用药公开标签（2026-01-23 更新）", "en": "Current U.S. generic DailyMed label (updated 23 Jan 2026)" }, "dosageForm": { "zh": "盐酸曲唑酮口服片", "en": "trazodone hydrochloride oral tablet" }, "route": { "zh": "口服（准确产品身份字段）", "en": "oral (exact-product identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 70771-1129-1", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片盐酸曲唑酮 100 mg；100 片瓶装", "en": "100 mg trazodone hydrochloride per tablet; 100-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=0b9d3b91-26ed-477b-a88e-2d6a76fedabf-02.jpg&setid=43d4be17-5fae-4326-a5c4-9e25e2db6a43&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "盐酸曲唑酮", "en": "trazodone hydrochloride" }, "value": 100, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、睡眠用途、掰片、加减量、停药或换药指令", "en": "labelled amount per tablet; not an individual's tablet count, sleep use, splitting, dose change, stopping or switching instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-30", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": null, "shape": { "zh": "片剂外观与刻痕须回到所引当前标签和实际药盒核对；不从包装正面推定能否掰片", "en": "Check tablet appearance and score against the cited current label and actual pack; do not infer splitting from the front panel" }, "imprint": null, "scoreStatus": "verify_exact_current_label_before_splitting", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_c27a916390cb224f", "label": "DailyMed（NLM）：盐酸曲唑酮片当前美国通用药公开标签、Medication Guide 与准确包装面板（2026-01-23 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=43d4be17-5fae-4326-a5c4-9e25e2db6a43&version=8", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-trazodone-hydrochloride-150mg-100-bottle-ndc-7077111301", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国通用药公开标签（2026-01-23 更新）", "en": "Current U.S. generic DailyMed label (updated 23 Jan 2026)" }, "dosageForm": { "zh": "盐酸曲唑酮口服片", "en": "trazodone hydrochloride oral tablet" }, "route": { "zh": "口服（准确产品身份字段）", "en": "oral (exact-product identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 70771-1130-1", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片盐酸曲唑酮 150 mg；100 片瓶装", "en": "150 mg trazodone hydrochloride per tablet; 100-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=0b9d3b91-26ed-477b-a88e-2d6a76fedabf-03.jpg&setid=43d4be17-5fae-4326-a5c4-9e25e2db6a43&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "盐酸曲唑酮", "en": "trazodone hydrochloride" }, "value": 150, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、睡眠用途、掰片、加减量、停药或换药指令", "en": "labelled amount per tablet; not an individual's tablet count, sleep use, splitting, dose change, stopping or switching instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-30", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": null, "shape": { "zh": "片剂外观与刻痕须回到所引当前标签和实际药盒核对；不从包装正面推定能否掰片", "en": "Check tablet appearance and score against the cited current label and actual pack; do not infer splitting from the front panel" }, "imprint": null, "scoreStatus": "verify_exact_current_label_before_splitting", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_c27a916390cb224f", "label": "DailyMed（NLM）：盐酸曲唑酮片当前美国通用药公开标签、Medication Guide 与准确包装面板（2026-01-23 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=43d4be17-5fae-4326-a5c4-9e25e2db6a43&version=8", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-trazodone-hydrochloride-300mg-100-bottle-ndc-7077111311", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国通用药公开标签（2026-01-23 更新）", "en": "Current U.S. generic DailyMed label (updated 23 Jan 2026)" }, "dosageForm": { "zh": "盐酸曲唑酮口服片", "en": "trazodone hydrochloride oral tablet" }, "route": { "zh": "口服（准确产品身份字段）", "en": "oral (exact-product identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 70771-1131-1", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片盐酸曲唑酮 300 mg；100 片瓶装", "en": "300 mg trazodone hydrochloride per tablet; 100-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=0b9d3b91-26ed-477b-a88e-2d6a76fedabf-04.jpg&setid=43d4be17-5fae-4326-a5c4-9e25e2db6a43&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "盐酸曲唑酮", "en": "trazodone hydrochloride" }, "value": 300, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、睡眠用途、掰片、加减量、停药或换药指令", "en": "labelled amount per tablet; not an individual's tablet count, sleep use, splitting, dose change, stopping or switching instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-30", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": null, "shape": { "zh": "片剂外观与刻痕须回到所引当前标签和实际药盒核对；不从包装正面推定能否掰片", "en": "Check tablet appearance and score against the cited current label and actual pack; do not infer splitting from the front panel" }, "imprint": null, "scoreStatus": "verify_exact_current_label_before_splitting", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_c27a916390cb224f", "label": "DailyMed（NLM）：盐酸曲唑酮片当前美国通用药公开标签、Medication Guide 与准确包装面板（2026-01-23 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=43d4be17-5fae-4326-a5c4-9e25e2db6a43&version=8", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-trazodone-hydrochloride-50mg-100-bottle-ndc-7077111281", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=0b9d3b91-26ed-477b-a88e-2d6a76fedabf-01.jpg&setid=43d4be17-5fae-4326-a5c4-9e25e2db6a43&type=img", "alt": "盐酸曲唑酮 50 mg、NDC 70771-1128-1、100 片瓶装在美国 DailyMed 当前通用药标签中的展示面", "archiveMarket": "美国", "labelVersion": "DailyMed 当前通用药标签；2026-01-23 更新", "presentation": "盐酸曲唑酮片：每片 50 mg，NDC 70771-1128-1，100 片瓶装。", "notice": "此图只对应所引当前美国通用药标签中的 50 mg、NDC 70771-1128-1、100 片瓶装。它不是 DESYREL 历史品牌包装，不代表其他强度、厂家、市场、库存或原研身份，不用于鉴定真伪，也不生成个人睡眠/抑郁用药方案。", "source": { "id": "src_c27a916390cb224f", "label": "DailyMed（NLM）：盐酸曲唑酮片当前美国通用药公开标签、Medication Guide 与准确包装面板（2026-01-23 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=43d4be17-5fae-4326-a5c4-9e25e2db6a43&version=8", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "DESYREL／曲唑酮说明书放大阅读：先分历史品牌、当前通用药与睡眠用途误解", "en": "DESYREL / trazodone label reading: separate brand history, current generics and sleep-use assumptions" }, "summary": { "zh": "当前通用药标签把盐酸曲唑酮列为成人重性抑郁障碍用药；网页不会因为它常被讨论为助眠药，就推导任何人的睡眠用途、片数、时间、加减量或停药方案。先核对准确产品、每片 mg、实际处方、完整药单与目标市场标签。", "en": "The current generic label identifies trazodone hydrochloride for major depressive disorder in adults. Common discussion of sleep use does not let this site derive an individual's sleep use, tablet count, timing, dose change or stopping plan. Check the exact product, mg per tablet, actual prescription, full medicine list and target-market label." }, "checks": [ { "zh": "50、100、150、300 mg 是四种当前通用药片剂的每片标示量，不是把数字相加、用多片拼规格或根据睡眠时长自行选片数的计算器。刻痕也必须按准确厂家标签和处方核对，不能看到线就自行掰片。", "en": "50, 100, 150 and 300 mg are labelled amounts per tablet for four current generic products. They are not a calculator for adding numbers, assembling a strength or choosing tablets from sleep duration. A score must be checked against the exact manufacturer label and prescription rather than treated as automatic permission to split." }, { "zh": "嗜睡、头晕、认知或运动反应受影响时不要驾驶或操作危险设备。老人、使用降压药、利尿药、安眠镇静药、酒精或其他中枢抑制物者，应优先核对体位性低血压、晕厥、跌倒、脱水和完整药单。", "en": "Do not drive or operate hazardous machinery when somnolence, dizziness or impaired cognitive/motor performance occurs. Older adults and people using blood-pressure medicines, diuretics, sedatives, alcohol or other CNS depressants need priority review for orthostatic hypotension, syncope, falls, dehydration and the complete medicine list." }, { "zh": "老年人、使用利尿药或容量不足者还需留意低钠。明显乏力、头痛、混乱、步态不稳、跌倒、抽搐或意识变化需要及时医疗评估，不能只归因于年龄或睡不好。", "en": "Older adults, people using diuretics or those who are volume depleted also need review for hyponatraemia. Marked weakness, headache, confusion, unsteady gait, falls, seizures or altered awareness needs timely medical assessment rather than attribution to age or poor sleep alone." }, { "zh": "另一种影响血清素的抗抑郁药、曲马多、锂剂、丁螺环酮、安非他明、色氨酸、圣约翰草、MAOI、利奈唑胺或静脉亚甲蓝同在药单时，应优先核对血清素综合征与禁忌边界；不要自行叠加、错开或轮换。", "en": "Another serotonergic antidepressant, tramadol, lithium, buspirone, amphetamine, tryptophan, St John's wort, an MAOI, linezolid or intravenous methylene blue on the list requires priority review for serotonin syndrome and contraindication boundaries. Do not self-combine, time-separate or alternate them." }, { "zh": "QT 延长或心律问题、低钾/低镁、相关药物，及阿司匹林、NSAID、抗血小板药或抗凝药同在药单时，应优先核对心律与出血风险。晕厥、胸痛、明显心悸、严重出血或其他急性重症应立即使用当地急救渠道。", "en": "QT prolongation or another rhythm condition, low potassium/magnesium, related medicines, or aspirin, NSAIDs, antiplatelets or anticoagulants on the list requires priority review of rhythm and bleeding risk. Fainting, chest pain, marked palpitations, severe bleeding or another acute serious concern requires immediate local emergency care." }, { "zh": "自伤/自杀想法、明显行为改变、严重过敏样反应、持续勃起伴疼痛或其他急性严重问题需要立即使用当地急救或危机支持；不要等待网页，也不要用另一盒药自行抵消。", "en": "Thoughts of self-harm/suicide, marked behavioural change, a severe allergy-like reaction, a persistent painful erection or another acute serious concern requires immediate local emergency or crisis support. Do not wait for a webpage or try to counteract it with another pack." } ], "source": { "id": "src_c27a916390cb224f", "label": "DailyMed（NLM）：盐酸曲唑酮片当前美国通用药公开标签、Medication Guide 与准确包装面板（2026-01-23 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=43d4be17-5fae-4326-a5c4-9e25e2db6a43&version=8", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "曲唑酮怎样起作用：血清素相关作用不能推导个人助眠或抗抑郁方案", "en": "How trazodone works: serotonergic activity cannot determine an individual's sleep or antidepressant plan" }, "summary": { "zh": "标签把曲唑酮的抗抑郁作用与血清素再摄取及受体作用联系起来，但完整治疗机制并不能替个人判断适用性、睡眠用途、优劣、片数或与其他精神神经药联用。", "en": "The label relates trazodone's antidepressant activity to serotonin reuptake and receptor effects, but the therapeutic mechanism cannot determine individual suitability, sleep use, superiority, tablet count or combination with other neuropsychiatric medicines." }, "checks": [ { "zh": "“会嗜睡”不是“就是安眠药”，也不是自行开始、与 DAYVIGO、BELSOMRA、AMBIEN、苯二氮卓类、抗组胺药或酒精叠加的依据。", "en": "‘May cause drowsiness’ does not mean ‘is automatically a sleeping pill’ and does not justify self-starting or combining with DAYVIGO, BELSOMRA, AMBIEN, benzodiazepines, antihistamines or alcohol." }, { "zh": "共同影响血清素不表示曲唑酮能与 CELEXA、LEXAPRO、ZOLOFT、PROZAC、PAXIL、CYMBALTA、EFFEXOR、TRINTELLIX 等按 mg 换算、轮换或叠加。", "en": "Shared serotonergic activity does not permit milligram conversion, rotation or combination of trazodone with CELEXA, LEXAPRO, ZOLOFT, PROZAC, PAXIL, CYMBALTA, EFFEXOR, TRINTELLIX or another product." }, { "zh": "历史品牌、当前通用药与相同活性成分可以帮助建立监管和包装核对路径，但不能从机制、商品名或药盒图片判断哪一盒更适合某个人、是否能替代或是否应停换。", "en": "Brand history, current generics and a shared active ingredient can establish regulatory and pack-checking routes, but mechanism, trade name or a pack image cannot determine which product suits an individual, whether it is substitutable or whether it should be stopped or switched." } ], "source": { "id": "src_c27a916390cb224f", "label": "DailyMed（NLM）：盐酸曲唑酮片当前美国通用药公开标签、Medication Guide 与准确包装面板（2026-01-23 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=43d4be17-5fae-4326-a5c4-9e25e2db6a43&version=8", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "DESYREL / trazodone", "generic": "盐酸曲唑酮", "dosageFormClass": "口服片：当前展示每片 50 mg、100 mg、150 mg、300 mg 盐酸曲唑酮；不把普通片与任何缓释产品或其他市场产品合并" }, "labelSource": { "id": "src_c27a916390cb224f", "label": "DailyMed（NLM）：盐酸曲唑酮片当前美国通用药公开标签、Medication Guide 与准确包装面板（2026-01-23 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=43d4be17-5fae-4326-a5c4-9e25e2db6a43&version=8", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "productRoutes": [ { "source": { "id": "src_c27a916390cb224f", "label": "DailyMed（NLM）：盐酸曲唑酮片当前美国通用药公开标签、Medication Guide 与准确包装面板（2026-01-23 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=43d4be17-5fae-4326-a5c4-9e25e2db6a43&version=8", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-30", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_d6fd87b9f180c6f5", "label": "FDA：DESYREL（trazodone hydrochloride）NDA 018207 品牌标签档案（2018）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/018207s033lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-08-30", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-30", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "DESYREL 是盐酸曲唑酮 1981 年美国初始批准品牌的历史档案；本页当前可核对的四个准确包装来自 2026 年更新的美国通用药标签。曲唑酮标签适应症是成人重性抑郁障碍，不应因为常被谈及睡眠就把网页变成个人助眠建议。页面优先解释每片 mg、品牌历史与当前通用药、嗜睡/驾驶、体位性低血压与跌倒、低钠、QT、出血、血清素综合征及完整药单核对边界。", "history": "FDA 记录显示 DESYREL NDA 018207 的美国初始批准年份为 1981。2018 年品牌标签仍可作为历史监管文档阅读；2026 年 DailyMed 当前通用药标签提供四个 100 片瓶装展示面。两类资料共同用于讲清产品历史和当前准确包装，但不证明 DESYREL 品牌当前有货或可购买。", "sourceDocuments": [ { "id": "src_c27a916390cb224f", "label": "DailyMed（NLM）：盐酸曲唑酮片当前美国通用药公开标签、Medication Guide 与准确包装面板（2026-01-23 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=43d4be17-5fae-4326-a5c4-9e25e2db6a43&version=8", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, { "id": "src_d6fd87b9f180c6f5", "label": "FDA：DESYREL（trazodone hydrochloride）NDA 018207 品牌标签档案（2018）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/018207s033lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, { "id": "src_bf3886fc5e7376a8", "label": "FDA Drugs@FDA：DESYREL／trazodone hydrochloride NDA 018207 申请记录", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=018207", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_database_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" } ], "applicationNumber": "FDA NDA 018207（DESYREL／trazodone hydrochloride）", "approvalTimeline": [ { "date": "1981", "title": { "zh": "DESYREL 美国初始批准", "en": "Initial U.S. DESYREL approval" }, "detail": { "zh": "FDA 标签记录将 DESYREL 的美国初始批准年份列为 1981。该历史节点不证明当前品牌包装、持有人、供应或可购买性。", "en": "FDA labelling lists 1981 as the initial U.S. approval year for DESYREL. This historical point does not establish a current brand pack, holder, supply or purchase availability." }, "source": { "id": "src_d6fd87b9f180c6f5", "label": "FDA：DESYREL（trazodone hydrochloride）NDA 018207 品牌标签档案（2018）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/018207s033lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" } }, { "date": "2018", "title": { "zh": "DESYREL 品牌标签档案", "en": "DESYREL brand-label archive" }, "detail": { "zh": "FDA 公开 2018 年 NDA 018207 品牌标签，保留适应症、黑框警示及安全阅读路径；页面将其明确标为历史品牌资料。", "en": "FDA publishes a 2018 NDA 018207 brand label preserving indication, boxed-warning and safety-reading paths. The page explicitly treats it as historical brand material." }, "source": { "id": "src_d6fd87b9f180c6f5", "label": "FDA：DESYREL（trazodone hydrochloride）NDA 018207 品牌标签档案（2018）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/018207s033lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" } }, { "date": "2026-01-23", "title": { "zh": "当前通用药标签更新", "en": "Current generic label updated" }, "detail": { "zh": "DailyMed 当前标签展示 50、100、150、300 mg 四个 100 片瓶装面板。标签存在不证明当地库存、可购买性或个人适用性。", "en": "The current DailyMed label displays 50, 100, 150 and 300 mg 100-tablet bottle panels. A label does not establish local stock, purchase availability or individual suitability." }, "source": { "id": "src_c27a916390cb224f", "label": "DailyMed（NLM）：盐酸曲唑酮片当前美国通用药公开标签、Medication Guide 与准确包装面板（2026-01-23 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=43d4be17-5fae-4326-a5c4-9e25e2db6a43&version=8", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "已链接 DESYREL 历史品牌标签、NDA 记录与当前通用药准确包装", "en": "Historical DESYREL brand label, NDA record and current exact generic packs linked" }, "detail": { "zh": "历史品牌与当前通用药分开呈现，不把通用药包装冒充 DESYREL，也不把历史标签写成实时供应。", "en": "Brand history and current generic products remain separate; generic packs are not passed off as DESYREL and a historical label is not described as live supply." } }, { "market": { "zh": "中国大陆、日本、欧盟及其他市场", "en": "Mainland China, Japan, EU and other markets" }, "status": { "zh": "待逐项建立现行监管产品记录", "en": "Current regulatory product records not yet established" }, "detail": { "zh": "不从美国品牌史、通用名或 mg 数字推定其他市场批准、包装、供应、原研/仿制关系或可替代性。", "en": "No approval, pack, supply, originator/generic relationship or interchangeability in another market is inferred from U.S. brand history, generic name or milligram figures." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "曲唑酮是不是安眠药？", "en": "Is trazodone a sleeping pill?" }, "answer": { "zh": "本页所引美国标签适应症是成人重性抑郁障碍。嗜睡是需要阅读和防跌倒的安全线索，不等于网页为任何人确认睡眠用途、时间或片数。实际处方目的和用法必须由负责治疗的团队解释。", "en": "The cited U.S. label indicates major depressive disorder in adults. Somnolence is a safety and fall-prevention cue, not webpage confirmation of a sleep use, time or tablet count for anyone. The treating team must explain the actual prescription purpose and directions." } }, { "question": { "zh": "有刻痕就可以自己掰吗？", "en": "Does a score mean I can split it myself?" }, "answer": { "zh": "不能只看刻痕。不同厂家、强度、片形和标签可能不同；必须按准确 NDC、厂家标签和个人处方核对。网页不把包装或药片外观变成个人掰片方案。", "en": "Do not rely on a score alone. Manufacturer, strength, tablet design and label can differ; check the exact NDC, manufacturer label and prescription. The site does not turn pack or tablet appearance into an individual splitting plan." } }, { "question": { "zh": "DESYREL 包装和这里的通用药包装为什么不同？", "en": "Why does a DESYREL pack differ from the generic packs shown here?" }, "answer": { "zh": "DESYREL 是历史品牌身份；当前四张包装图来自另一份美国通用药标签。共同成分不表示同一厂家、同一包装或当前品牌供应。", "en": "DESYREL is a historical brand identity. The four current pack images come from a separate U.S. generic label. A shared ingredient does not mean the same manufacturer, pack or current brand supply." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "family-medicine-list-for-pharmacist", "dosage-forms-are-part-of-medicine-identity", "generic-drugs-and-bioequivalence" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/desyrel-trazodone/", "en": "https://origindrug.com/en/drugs/desyrel-trazodone/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "belsomra-suvorexant", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-30", "status": "published_traceable_archive" }, "names": { "brand": "BELSOMRA", "generic": "苏沃雷生", "aliases": [ "Belsomra", "ベルソムラ", "BelSOMRA", "suvorexant", "苏沃雷生", "スボレキサント", "苏沃雷生片", "BELSOMRA", "NDA 204569", "0006-0005-30", "0006-0033-30", "0006-0325-30", "0006-0335-30", "22800AMX00671000", "22600AMX01302000", "22600AMX01303000" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "精神健康", "sourceArchiveMarket": "美国 BELSOMRA 当前品牌标签 5/10/15/20 mg 四个 30 片泡罩纸盒；日本 PMDA 当前 ベルソムラ 10/15/20 mg 三个产品身份、电子说明书和患者指南", "dosageFormClass": "口服薄膜衣片；美国 5、10、15、20 mg，30 片单位使用泡罩纸盒，C-IV 管制药物；日本 10、15、20 mg 产品。市场说明、包装与监管分类必须分别阅读", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "2014（FDA NDA 204569；日本 2014/2016 批准产品）", "archiveSponsorText": "Merck Sharp & Dohme LLC（美国当前标签）；MSD 株式会社（日本 PMDA）" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [ "BELSOMRA", "ベルソムラ錠10mg", "ベルソムラ錠15mg", "ベルソムラ錠20mg" ], "excludedProductCues": [ "DAYVIGO", "lemborexant", "QUVIVIQ", "daridorexant", "AMBIEN", "zolpidem", "generic suvorexant", "other suvorexant product" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-belsomra-suvorexant-5mg-30-blister-carton-ndc-0006000530", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（SPL v21；2025-03-10 更新）", "en": "Current U.S. DailyMed public label (SPL v21; updated 10 Mar 2025)" }, "dosageForm": { "zh": "BELSOMRA 苏沃雷生口服薄膜衣片", "en": "BELSOMRA suvorexant oral film-coated tablet" }, "route": { "zh": "口服；准确产品身份字段，不据此生成个人片数、服用时间或补服方案", "en": "oral; exact product-identity field, not an individual tablet count, timing or make-up plan" }, "routeCodes": [ "oral" ], "productCode": "NDC 0006-0005-30", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片苏沃雷生 5 mg；30 片单位使用泡罩纸盒（3 板×10 片）", "en": "Suvorexant 5 mg per tablet; 30-tablet unit-of-use blister carton (3 cards × 10 tablets)" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=belsomra-04.jpg&setid=e5b72731-1acb-45b7-9c13-290ad12d3951", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "苏沃雷生", "en": "suvorexant" }, "value": 5, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、频率、服用时间、补服、停药或换药指令", "en": "labelled amount per tablet; not an individual's tablet count, frequency, timing, make-up, stopping or switching instruction" } } ], "concentration": null, "container": { "typeCode": "blister_carton", "typeLabel": { "zh": "单位使用泡罩纸盒", "en": "unit-of-use blister carton" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "片/盒", "en": "tablets per carton" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-30", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 30, "unit": { "zh": "片/盒（3 板×10 片）", "en": "tablets per carton (3 cards × 10 tablets)" } }, "physicalClues": { "color": { "zh": "黄色", "en": "yellow" }, "shape": { "zh": "圆形、薄膜衣片；无刻痕", "en": "round, film-coated tablet; unscored" }, "imprint": "5", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_58d585214668a64d", "label": "DailyMed（NLM）：BELSOMRA 5 mg、NDC 0006-0005-30、30 片泡罩纸盒当前美国标签面板", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=e5b72731-1acb-45b7-9c13-290ad12d3951", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-belsomra-suvorexant-10mg-30-blister-carton-ndc-0006003330", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（SPL v21；2025-03-10 更新）", "en": "Current U.S. DailyMed public label (SPL v21; updated 10 Mar 2025)" }, "dosageForm": { "zh": "BELSOMRA 苏沃雷生口服薄膜衣片", "en": "BELSOMRA suvorexant oral film-coated tablet" }, "route": { "zh": "口服；准确产品身份字段，不据此生成个人片数、服用时间或补服方案", "en": "oral; exact product-identity field, not an individual tablet count, timing or make-up plan" }, "routeCodes": [ "oral" ], "productCode": "NDC 0006-0033-30", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片苏沃雷生 10 mg；30 片单位使用泡罩纸盒（3 板×10 片）", "en": "Suvorexant 10 mg per tablet; 30-tablet unit-of-use blister carton (3 cards × 10 tablets)" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=belsomra-05.jpg&setid=e5b72731-1acb-45b7-9c13-290ad12d3951", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "苏沃雷生", "en": "suvorexant" }, "value": 10, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、频率、服用时间、补服、停药或换药指令", "en": "labelled amount per tablet; not an individual's tablet count, frequency, timing, make-up, stopping or switching instruction" } } ], "concentration": null, "container": { "typeCode": "blister_carton", "typeLabel": { "zh": "单位使用泡罩纸盒", "en": "unit-of-use blister carton" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "片/盒", "en": "tablets per carton" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-30", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 30, "unit": { "zh": "片/盒（3 板×10 片）", "en": "tablets per carton (3 cards × 10 tablets)" } }, "physicalClues": { "color": { "zh": "绿色", "en": "green" }, "shape": { "zh": "圆形、薄膜衣片；无刻痕", "en": "round, film-coated tablet; unscored" }, "imprint": "33", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_58d585214668a64d", "label": "DailyMed（NLM）：BELSOMRA 10 mg、NDC 0006-0033-30、30 片泡罩纸盒当前美国标签面板", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=e5b72731-1acb-45b7-9c13-290ad12d3951", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-belsomra-suvorexant-15mg-30-blister-carton-ndc-0006032530", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（SPL v21；2025-03-10 更新）", "en": "Current U.S. DailyMed public label (SPL v21; updated 10 Mar 2025)" }, "dosageForm": { "zh": "BELSOMRA 苏沃雷生口服薄膜衣片", "en": "BELSOMRA suvorexant oral film-coated tablet" }, "route": { "zh": "口服；准确产品身份字段，不据此生成个人片数、服用时间或补服方案", "en": "oral; exact product-identity field, not an individual tablet count, timing or make-up plan" }, "routeCodes": [ "oral" ], "productCode": "NDC 0006-0325-30", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片苏沃雷生 15 mg；30 片单位使用泡罩纸盒（3 板×10 片）", "en": "Suvorexant 15 mg per tablet; 30-tablet unit-of-use blister carton (3 cards × 10 tablets)" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=belsomra-06.jpg&setid=e5b72731-1acb-45b7-9c13-290ad12d3951", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "苏沃雷生", "en": "suvorexant" }, "value": 15, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、频率、服用时间、补服、停药或换药指令", "en": "labelled amount per tablet; not an individual's tablet count, frequency, timing, make-up, stopping or switching instruction" } } ], "concentration": null, "container": { "typeCode": "blister_carton", "typeLabel": { "zh": "单位使用泡罩纸盒", "en": "unit-of-use blister carton" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "片/盒", "en": "tablets per carton" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-30", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 30, "unit": { "zh": "片/盒（3 板×10 片）", "en": "tablets per carton (3 cards × 10 tablets)" } }, "physicalClues": { "color": { "zh": "白色", "en": "white" }, "shape": { "zh": "椭圆形、薄膜衣片；无刻痕", "en": "oval, film-coated tablet; unscored" }, "imprint": "325", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_58d585214668a64d", "label": "DailyMed（NLM）：BELSOMRA 15 mg、NDC 0006-0325-30、30 片泡罩纸盒当前美国标签面板", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=e5b72731-1acb-45b7-9c13-290ad12d3951", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-belsomra-suvorexant-20mg-30-blister-carton-ndc-0006033530", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（SPL v21；2025-03-10 更新）", "en": "Current U.S. DailyMed public label (SPL v21; updated 10 Mar 2025)" }, "dosageForm": { "zh": "BELSOMRA 苏沃雷生口服薄膜衣片", "en": "BELSOMRA suvorexant oral film-coated tablet" }, "route": { "zh": "口服；准确产品身份字段，不据此生成个人片数、服用时间或补服方案", "en": "oral; exact product-identity field, not an individual tablet count, timing or make-up plan" }, "routeCodes": [ "oral" ], "productCode": "NDC 0006-0335-30", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片苏沃雷生 20 mg；30 片单位使用泡罩纸盒（3 板×10 片）", "en": "Suvorexant 20 mg per tablet; 30-tablet unit-of-use blister carton (3 cards × 10 tablets)" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=belsomra-07.jpg&setid=e5b72731-1acb-45b7-9c13-290ad12d3951", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "苏沃雷生", "en": "suvorexant" }, "value": 20, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、频率、服用时间、补服、停药或换药指令", "en": "labelled amount per tablet; not an individual's tablet count, frequency, timing, make-up, stopping or switching instruction" } } ], "concentration": null, "container": { "typeCode": "blister_carton", "typeLabel": { "zh": "单位使用泡罩纸盒", "en": "unit-of-use blister carton" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "片/盒", "en": "tablets per carton" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-30", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 30, "unit": { "zh": "片/盒（3 板×10 片）", "en": "tablets per carton (3 cards × 10 tablets)" } }, "physicalClues": { "color": { "zh": "白色", "en": "white" }, "shape": { "zh": "圆形、薄膜衣片；无刻痕", "en": "round, film-coated tablet; unscored" }, "imprint": "335", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_58d585214668a64d", "label": "DailyMed（NLM）：BELSOMRA 20 mg、NDC 0006-0335-30、30 片泡罩纸盒当前美国标签面板", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=e5b72731-1acb-45b7-9c13-290ad12d3951", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "jp-belsomra-suvorexant-10mg-tablet-22800amx00671000", "marketCode": "JP", "labelVersion": { "zh": "PMDA 当前日本电子说明书（2026-03 修订；2026-08-30 核验）", "en": "Current Japanese PMDA electronic label (revised Mar 2026; verified 30 Aug 2026)" }, "dosageForm": { "zh": "ベルソムラ 苏沃雷生口服薄膜衣片", "en": "BELSOMRA suvorexant oral film-coated tablet (Japan)" }, "route": { "zh": "口服（日本准确产品身份字段）", "en": "oral (exact Japanese product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "PMDA 22800AMX00671000", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片苏沃雷生 10 mg；日本 PMDA 产品身份", "en": "Suvorexant 10 mg per tablet; Japanese PMDA product identity" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "苏沃雷生（スボレキサント）", "en": "suvorexant" }, "value": 10, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片日本标签标示量；不是个人片数、频率、年龄对应用法或跨市场换算", "en": "Japanese labelled amount per tablet; not an individual's tablet count, frequency, age-based regimen or cross-market conversion" } } ], "concentration": null, "container": { "typeCode": "not_established", "typeLabel": { "zh": "包装数量未在本身份卡中建立", "en": "pack count not established in this identity card" }, "fill": null, "countPerPackage": null, "countUnit": null }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-30", "currentLabelDisplayed": true, "ndcDirectoryListed": false, "marketAvailability": "active_regulatory_record", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": null, "physicalClues": { "color": { "zh": "极浅绿色", "en": "very pale green" }, "shape": { "zh": "圆形薄膜衣片", "en": "round film-coated tablet" }, "imprint": "33", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_6b52137ca193d9e0", "label": "日本 PMDA：ベルソムラ（苏沃雷生）10/15/20 mg 当前专业产品记录、电子说明书、患者指南与安全资料入口", "url": "https://www.pmda.go.jp/PmdaSearch/rdDetail/iyaku/1190023F1024_1?user=1", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_database_record", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "jp-belsomra-suvorexant-15mg-tablet-22600amx01302000", "marketCode": "JP", "labelVersion": { "zh": "PMDA 当前日本电子说明书（2026-03 修订；2026-08-30 核验）", "en": "Current Japanese PMDA electronic label (revised Mar 2026; verified 30 Aug 2026)" }, "dosageForm": { "zh": "ベルソムラ 苏沃雷生口服薄膜衣片", "en": "BELSOMRA suvorexant oral film-coated tablet (Japan)" }, "route": { "zh": "口服（日本准确产品身份字段）", "en": "oral (exact Japanese product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "PMDA 22600AMX01302000", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片苏沃雷生 15 mg；日本 PMDA 产品身份", "en": "Suvorexant 15 mg per tablet; Japanese PMDA product identity" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "苏沃雷生（スボレキサント）", "en": "suvorexant" }, "value": 15, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片日本标签标示量；不是个人片数、频率、年龄对应用法或跨市场换算", "en": "Japanese labelled amount per tablet; not an individual's tablet count, frequency, age-based regimen or cross-market conversion" } } ], "concentration": null, "container": { "typeCode": "not_established", "typeLabel": { "zh": "包装数量未在本身份卡中建立", "en": "pack count not established in this identity card" }, "fill": null, "countPerPackage": null, "countUnit": null }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-30", "currentLabelDisplayed": true, "ndcDirectoryListed": false, "marketAvailability": "active_regulatory_record", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": null, "physicalClues": { "color": { "zh": "白色", "en": "white" }, "shape": { "zh": "椭圆形薄膜衣片", "en": "oval film-coated tablet" }, "imprint": "325", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_6b52137ca193d9e0", "label": "日本 PMDA：ベルソムラ（苏沃雷生）10/15/20 mg 当前专业产品记录、电子说明书、患者指南与安全资料入口", "url": "https://www.pmda.go.jp/PmdaSearch/rdDetail/iyaku/1190023F1024_1?user=1", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_database_record", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "jp-belsomra-suvorexant-20mg-tablet-22600amx01303000", "marketCode": "JP", "labelVersion": { "zh": "PMDA 当前日本电子说明书（2026-03 修订；2026-08-30 核验）", "en": "Current Japanese PMDA electronic label (revised Mar 2026; verified 30 Aug 2026)" }, "dosageForm": { "zh": "ベルソムラ 苏沃雷生口服薄膜衣片", "en": "BELSOMRA suvorexant oral film-coated tablet (Japan)" }, "route": { "zh": "口服（日本准确产品身份字段）", "en": "oral (exact Japanese product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "PMDA 22600AMX01303000", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片苏沃雷生 20 mg；日本 PMDA 产品身份", "en": "Suvorexant 20 mg per tablet; Japanese PMDA product identity" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "苏沃雷生（スボレキサント）", "en": "suvorexant" }, "value": 20, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片日本标签标示量；不是个人片数、频率、年龄对应用法或跨市场换算", "en": "Japanese labelled amount per tablet; not an individual's tablet count, frequency, age-based regimen or cross-market conversion" } } ], "concentration": null, "container": { "typeCode": "not_established", "typeLabel": { "zh": "包装数量未在本身份卡中建立", "en": "pack count not established in this identity card" }, "fill": null, "countPerPackage": null, "countUnit": null }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-30", "currentLabelDisplayed": true, "ndcDirectoryListed": false, "marketAvailability": "active_regulatory_record", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": null, "physicalClues": { "color": { "zh": "白色", "en": "white" }, "shape": { "zh": "圆形薄膜衣片", "en": "round film-coated tablet" }, "imprint": "335", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_6b52137ca193d9e0", "label": "日本 PMDA：ベルソムラ（苏沃雷生）10/15/20 mg 当前专业产品记录、电子说明书、患者指南与安全资料入口", "url": "https://www.pmda.go.jp/PmdaSearch/rdDetail/iyaku/1190023F1024_1?user=1", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_database_record", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-belsomra-suvorexant-10mg-30-blister-carton-ndc-0006003330", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=belsomra-05.jpg&setid=e5b72731-1acb-45b7-9c13-290ad12d3951", "alt": "BELSOMRA 苏沃雷生 10 mg、NDC 0006-0033-30、30 片泡罩纸盒在美国 DailyMed 当前标签中的展示面", "archiveMarket": "美国", "labelVersion": "DailyMed SPL v21（2025-03-10 更新）", "presentation": "BELSOMRA 10 mg、NDC 0006-0033-30、30 片泡罩纸盒标签展示面", "notice": "此图只对应美国当前标签中的 BELSOMRA 10 mg、NDC 0006-0033-30、30 片泡罩纸盒。其他强度各有独立包装卡；它不代表日本包装、DAYVIGO、QUVIVIQ、AMBIEN、通用药、库存或可购买资格，不用于鉴定真伪或生成个人服用安排。", "source": { "id": "src_58d585214668a64d", "label": "DailyMed（NLM）：BELSOMRA 苏沃雷生口服片当前美国公开标签、Medication Guide 与四个 30 片泡罩纸盒面板（SPL v21；2025-03-10 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=e5b72731-1acb-45b7-9c13-290ad12d3951", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "BELSOMRA 说明书放大阅读：先核对每片 mg，再看次日清醒、跌倒与合并用药", "en": "BELSOMRA label reading: check mg per tablet, next-day alertness, falls and co-medication" }, "summary": { "zh": "5、10、15、20 mg 是每片苏沃雷生的标签标示量，不是网页给出的个人服用方案。老人或同时使用安眠药、镇静药、阿片类、酒精及 CYP3A 相关药物者，更需要把完整药单和实际药盒交给专业人员核对。", "en": "The 5, 10, 15 and 20 mg figures are labelled suvorexant amounts per tablet, not a personal regimen supplied by this site. Older adults and people also using sleep medicines, sedatives, opioids, alcohol or CYP3A-related medicines particularly need professional review of the full medicine list and actual pack." }, "checks": [ { "zh": "不要把包装上的 mg 当成‘应该吃几颗’。美国和日本产品强度及标签用法文字不同；年龄、药物相互作用和所在市场都不能由网页换算成个人片数、时间或补服方案。", "en": "Do not read the pack mg as a tablet count. U.S. and Japanese strengths and label instructions differ; age, interactions and market cannot be converted by this site into an individual tablet count, timing or make-up plan." }, { "zh": "苏沃雷生可能影响次日清醒、注意力和运动协调。早晨仍困倦、反应变慢、步态不稳或老人跌倒时，不要自行驾车、操作危险设备、追加另一种安眠药或用酒精‘帮助睡眠’，应及时联系专业人员核对。", "en": "Suvorexant can affect next-day alertness, attention and motor coordination. If morning drowsiness, slowed reactions, unsteady gait or a fall occurs, do not drive, operate hazardous equipment, add another sleep medicine or use alcohol to ‘help sleep’; seek timely professional review." }, { "zh": "梦游、睡眠驾驶、在未完全清醒时进食、打电话或进行其他活动属于复杂睡眠行为警讯。若发生，应确保安全并立即联系开方团队；受伤、意识异常或其他急性危险应使用当地急救支持。", "en": "Sleep-walking, sleep-driving, eating, making calls or other activities while not fully awake are complex-sleep-behaviour warning signs. If this occurs, secure immediate safety and contact the prescriber; injury, altered awareness or another acute danger requires local emergency support." }, { "zh": "酒精、阿片类、苯二氮䓬类、其他安眠镇静药、部分抗过敏药和其他中枢抑制药可能叠加嗜睡、反应变慢、呼吸或跌倒风险。不要按‘都是晚上吃’自行叠加、轮换或共享。", "en": "Alcohol, opioids, benzodiazepines, other sleep/sedative medicines, some allergy medicines and other CNS depressants can add drowsiness, slowed reactions, breathing or fall risk. Do not combine, rotate or share them merely because they are all used at night." }, { "zh": "强或中度 CYP3A 抑制剂及诱导剂会影响专业用药安排；日本现行说明书还列出若干不能合并使用的药物。带上抗感染药、心血管药、抗真菌药、抗病毒药、保健品和完整药单核对，不能只凭一个药名决定同服。", "en": "Strong or moderate CYP3A inhibitors and inducers can affect professional management, and the current Japanese label lists several medicines that must not be combined. Bring anti-infectives, cardiovascular medicines, antifungals, antivirals, supplements and the full list for review rather than deciding from one name." }, { "zh": "发作性睡病是美国标签禁忌；呼吸功能受损、抑郁或自伤想法变化、睡眠瘫痪、幻觉样体验和猝倒样症状也需要专业评估。网页不会用睡眠时长、年龄或症状自行诊断或选药。", "en": "Narcolepsy is a U.S. label contraindication. Compromised respiratory function, worsening depression or self-harm thoughts, sleep paralysis, hallucination-like experiences and cataplexy-like symptoms also need professional assessment. The site does not diagnose or select treatment from sleep duration, age or symptoms." } ], "source": { "id": "src_58d585214668a64d", "label": "DailyMed（NLM）：BELSOMRA 苏沃雷生口服片当前美国公开标签、Medication Guide 与四个 30 片泡罩纸盒面板（SPL v21；2025-03-10 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=e5b72731-1acb-45b7-9c13-290ad12d3951", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "苏沃雷生怎样作用：阻断 OX1R 与 OX2R 食欲素受体，减弱促清醒信号", "en": "How suvorexant works: blocking OX1R and OX2R orexin receptors to reduce wake signalling" }, "summary": { "zh": "苏沃雷生是双食欲素受体拮抗剂，可结合 OX1R 和 OX2R，抑制食欲素系统的促清醒作用。通俗地说，它不是把所有神经活动‘关掉’，而是减弱一种维持清醒的信号；这个机制不能预测某个人是否适合、该选多少 mg，或能否与其他安眠镇静药叠加。", "en": "Suvorexant is a dual orexin-receptor antagonist that binds OX1R and OX2R and suppresses wake-promoting orexin signalling. In plain language, it does not ‘switch off’ all brain activity; it reduces one wake-maintaining signal. This mechanism cannot predict individual suitability, strength choice or safe combination with another sleep or sedative medicine." }, "checks": [ { "zh": "与唑吡坦、苯二氮䓬类或其他睡眠药作用机制不同，不表示它更适合每个人，也不表示可以按 mg 对换、隔天轮换或叠加。", "en": "A different mechanism from zolpidem, benzodiazepines or other sleep medicines does not make it better for everyone or permit milligram substitution, alternate-day rotation or combination." }, { "zh": "原研与仿制产品可以共享活性成分和监管等效性依据，但外观、辅料与包装未必相同；替代必须查目标市场现行批准和个人处方，不能从颜色、共同机制或商品名自行决定。", "en": "Originator and generic products can share an active ingredient and regulatory equivalence basis while appearance, excipients and packaging may differ. Substitution requires the current target-market approval and individual prescription, not colour, a shared mechanism or brand name." }, { "zh": "食欲素系统参与维持清醒，但‘阻断促清醒信号’不等于可以从失眠表现推断病因，也不能据此忽略次日困倦、跌倒、呼吸、情绪或复杂睡眠行为等完整标签警示。", "en": "Orexin signalling helps maintain wakefulness, but ‘blocking a wake signal’ cannot establish the cause of insomnia or displace the full label warnings about next-day impairment, falls, breathing, mood or complex sleep behaviours." } ], "source": { "id": "src_58d585214668a64d", "label": "DailyMed（NLM）：BELSOMRA 苏沃雷生口服片当前美国公开标签、Medication Guide 与四个 30 片泡罩纸盒面板（SPL v21；2025-03-10 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=e5b72731-1acb-45b7-9c13-290ad12d3951", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "BELSOMRA", "generic": "苏沃雷生", "dosageFormClass": "口服薄膜衣片；美国 5、10、15、20 mg，30 片单位使用泡罩纸盒，C-IV 管制药物；日本 10、15、20 mg 产品。市场说明、包装与监管分类必须分别阅读" }, "labelSource": { "id": "src_58d585214668a64d", "label": "DailyMed（NLM）：BELSOMRA 苏沃雷生口服片当前美国公开标签、Medication Guide 与四个 30 片泡罩纸盒面板（SPL v21；2025-03-10 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=e5b72731-1acb-45b7-9c13-290ad12d3951", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "productRoutes": [ { "source": { "id": "src_58d585214668a64d", "label": "DailyMed（NLM）：BELSOMRA 苏沃雷生口服片当前美国公开标签、Medication Guide 与四个 30 片泡罩纸盒面板（SPL v21；2025-03-10 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=e5b72731-1acb-45b7-9c13-290ad12d3951", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-30", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_b0e3acba0771e25e", "label": "日本 PMDA：ベルソムラ 10/15/20 mg 当前电子说明书（2026-03 修订）", "url": "https://www.pmda.go.jp/PmdaSearch/iyakuDetail/ResultDataSetPDF/170050_1190023F1024_1_19", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "status": "product_level_public_record_verified", "authority": { "zh": "PMDA", "en": "PMDA" }, "market": { "zh": "日本", "en": "Japan" }, "recordType": { "zh": "监管产品记录", "en": "Regulatory product record" }, "reviewedAt": "2026-08-30", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-30", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "BELSOMRA 是苏沃雷生口服片的美国品牌，日本使用ベルソムラ。美国当前标签展示 5、10、15、20 mg 四个 30 片泡罩纸盒。本页优先帮助老人和家属核对每片 mg、次日清醒与驾驶、嗜睡跌倒、复杂睡眠行为、酒精及其他中枢抑制药、CYP3A 相互作用和呼吸风险；不生成个人片数、服用时间、补服、停药或换药方案。", "history": "FDA 于 2014-08-13 批准 NDA 204569。美国当前标签将 BELSOMRA 列为 C-IV 管制药物；日本 PMDA 当前记录列 10、15、20 mg 产品并提供专业说明书和患者指南。批准史、强度差异及各市场用法文字只用于来源核对，不能拿来跨市场自行选择强度或换算片数。", "sourceDocuments": [ { "id": "src_58d585214668a64d", "label": "DailyMed（NLM）：BELSOMRA 苏沃雷生口服片当前美国公开标签、Medication Guide 与四个 30 片泡罩纸盒面板（SPL v21；2025-03-10 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=e5b72731-1acb-45b7-9c13-290ad12d3951", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, { "id": "src_96ab5a582f5e5224", "label": "FDA Drugs@FDA：BELSOMRA（suvorexant）NDA 204569 申请与标签记录", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=204569", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_database_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, { "id": "src_9fd7fa645d512018", "label": "FDA：BELSOMRA（suvorexant）NDA 204569 初始批准函（2014-08-13）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204569Orig1s000rltr.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "regulatory_decision", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, { "id": "src_d306e20472ccaba8", "label": "FDA：BELSOMRA 苏沃雷生 NDA 204569 跨学科审评资料（5/10/15/20 mg）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/204569Orig1s000CrossR.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "regulatory_review", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, { "id": "src_f9a83bed7d1cd309", "label": "FDA：BELSOMRA NDA 204569/S-010 补充批准函与哺乳期标签更新（2025）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/204569Orig1s010ltr.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "regulatory_decision", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, { "id": "src_6b52137ca193d9e0", "label": "日本 PMDA：ベルソムラ（苏沃雷生）10/15/20 mg 当前专业产品记录、电子说明书、患者指南与安全资料入口", "url": "https://www.pmda.go.jp/PmdaSearch/rdDetail/iyaku/1190023F1024_1?user=1", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_database_record", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, { "id": "src_6e521835a493de99", "label": "日本 PMDA：ベルソムラ 10/15/20 mg 公众用药品信息入口", "url": "https://www.pmda.go.jp/PmdaSearch/rdDetail/iyaku/1190023F1024_1?user=2", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "consumer_medicine_information", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, { "id": "src_b0e3acba0771e25e", "label": "日本 PMDA：ベルソムラ 10/15/20 mg 当前电子说明书（2026-03 修订）", "url": "https://www.pmda.go.jp/PmdaSearch/iyakuDetail/ResultDataSetPDF/170050_1190023F1024_1_19", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, { "id": "src_a6b9b23fa67ca053", "label": "日本 PMDA：ベルソムラ 10/15/20 mg 患者向医药品指南", "url": "https://www.info.pmda.go.jp/downfiles/guide/ph/170050_1190023F1024_1_00G.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "consumer_medicine_information", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" } ], "applicationNumber": "FDA NDA 204569（BELSOMRA / suvorexant tablets）；日本 PMDA 1190023F1024", "approvalTimeline": [ { "date": "2014-08-13", "title": { "zh": "美国 NDA 204569 初始批准", "en": "Initial U.S. NDA 204569 approval" }, "detail": { "zh": "FDA 批准 BELSOMRA 苏沃雷生 5、10、15、20 mg 口服片；批准史不等于任何地点当前库存或个人适用性。", "en": "FDA approved BELSOMRA suvorexant 5, 10, 15 and 20 mg oral tablets. Approval history does not establish current local stock or individual suitability." }, "source": { "id": "src_9fd7fa645d512018", "label": "FDA：BELSOMRA（suvorexant）NDA 204569 初始批准函（2014-08-13）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204569Orig1s000rltr.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "regulatory_decision", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" } }, { "date": "2014-11-01", "title": { "zh": "日本 15 mg 与 20 mg 产品开始销售", "en": "Japanese 15 mg and 20 mg products launched" }, "detail": { "zh": "PMDA 当前说明书记录日本 15 mg、20 mg 产品的批准及销售节点；本页不由此生成任何年龄对应片数。", "en": "The current PMDA label records approval and launch milestones for the Japanese 15 mg and 20 mg products; this page does not turn them into an age-based tablet count." }, "source": { "id": "src_6b52137ca193d9e0", "label": "日本 PMDA：ベルソムラ（苏沃雷生）10/15/20 mg 当前专业产品记录、电子说明书、患者指南与安全资料入口", "url": "https://www.pmda.go.jp/PmdaSearch/rdDetail/iyaku/1190023F1024_1?user=1", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_database_record", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" } }, { "date": "2016-12-01", "title": { "zh": "日本 10 mg 产品开始销售", "en": "Japanese 10 mg product launched" }, "detail": { "zh": "PMDA 当前说明书记录 10 mg 产品后续加入；市场强度差异不是跨市场自行换算依据。", "en": "The current PMDA label records the later 10 mg product; market strength differences are not a basis for self-conversion." }, "source": { "id": "src_6b52137ca193d9e0", "label": "日本 PMDA：ベルソムラ（苏沃雷生）10/15/20 mg 当前专业产品记录、电子说明书、患者指南与安全资料入口", "url": "https://www.pmda.go.jp/PmdaSearch/rdDetail/iyaku/1190023F1024_1?user=1", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_database_record", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" } }, { "date": "2025-03-10", "title": { "zh": "当前美国 DailyMed 标签更新", "en": "Current U.S. DailyMed label updated" }, "detail": { "zh": "SPL v21 展示四个 30 片泡罩纸盒和 Medication Guide，并保留 C-IV、次日影响与复杂睡眠行为等安全边界。", "en": "SPL v21 displays four 30-tablet blister cartons and a Medication Guide, retaining C-IV, next-day impairment and complex-sleep-behaviour boundaries." }, "source": { "id": "src_58d585214668a64d", "label": "DailyMed（NLM）：BELSOMRA 苏沃雷生口服片当前美国公开标签、Medication Guide 与四个 30 片泡罩纸盒面板（SPL v21；2025-03-10 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=e5b72731-1acb-45b7-9c13-290ad12d3951", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "当前 BELSOMRA 品牌标签、Medication Guide、NDA 和四个准确泡罩纸盒已链接", "en": "Current BELSOMRA brand label, Medication Guide, NDA and four exact blister cartons linked" }, "detail": { "zh": "页面展示四个 30 片纸盒的官方标签面板；标签存在不证明本地库存、保险覆盖、可购买资格或个人适用性。", "en": "The page displays official label panels for four 30-tablet cartons. Label presence does not establish local stock, insurance coverage, purchase eligibility or individual suitability." } }, { "market": { "zh": "日本", "en": "Japan" }, "status": { "zh": "当前 ベルソムラ 10/15/20 mg 产品记录、电子说明书和患者指南已链接", "en": "Current BELSOMRA 10/15/20 mg product records, electronic label and patient guide linked" }, "detail": { "zh": "本轮保留 PMDA 产品身份和片剂外观文字，但未取得可与单一日本包装逐一对应的官方主展示面，因此不以美国药盒或零售图代替。", "en": "This review retains PMDA product identities and tablet-appearance text but did not obtain an official principal display panel matched one-to-one to a Japanese pack, so no U.S. carton or retail image is substituted." } }, { "market": { "zh": "中国大陆、欧盟及其他市场", "en": "Mainland China, European Union and other markets" }, "status": { "zh": "待逐项建立现行监管记录", "en": "Current regulatory records not yet established" }, "detail": { "zh": "不从美国或日本记录推定当地批准、供应、包装、处方资格或原研/仿制关系。", "en": "No local approval, supply, pack, prescription eligibility or originator/generic relationship is inferred from U.S. or Japanese records." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "BELSOMRA 是不是普通安眠药？", "en": "Is BELSOMRA just another ordinary sleeping pill?" }, "answer": { "zh": "它是双食欲素受体拮抗剂，作用机制和部分其他睡眠药不同，但仍可能造成次日困倦、复杂睡眠行为、跌倒和药物相互作用。不同机制不表示更安全或适合每个人。", "en": "It is a dual orexin-receptor antagonist with a different mechanism from some other sleep medicines, but it can still cause next-day drowsiness, complex sleep behaviours, falls and interactions. A different mechanism does not mean safer or suitable for everyone." } }, { "question": { "zh": "老人看到 10、15、20 mg，应该自己选哪一盒？", "en": "Which 10, 15 or 20 mg pack should an older adult choose?" }, "answer": { "zh": "不能从年龄或包装数字自行选择。不同市场标签、完整药单、肝功能、呼吸情况、跌倒风险和其他药物都可能影响专业决策；请把实际药盒与全部用药交给开方团队核对。", "en": "Do not choose from age or pack numbers. Market label, full medicine list, liver function, breathing status, fall risk and other medicines can affect professional decisions; have the prescriber review the actual pack and all medicines." } }, { "question": { "zh": "睡不着时能再加半片或和另一种安眠药一起吃吗？", "en": "Can I add half a tablet or another sleep medicine when I cannot sleep?" }, "answer": { "zh": "不要自行加片、掰片、补服或叠加。刻痕和包装 mg 不是加减量许可；额外中枢抑制可能增加次日影响、跌倒、复杂睡眠行为或呼吸风险。", "en": "Do not self-add, split, make up or combine tablets. A score or pack mg is not permission to change use; added CNS depression may increase next-day impairment, falls, complex sleep behaviours or breathing risk." } }, { "question": { "zh": "可以用酒精帮助药效吗？", "en": "Can alcohol help the medicine work?" }, "answer": { "zh": "不应把酒精当作助眠组合。酒精可能叠加嗜睡、协调受损、记忆问题和跌倒风险；带上真实饮酒情况让专业人员核对。", "en": "Alcohol should not be used as a sleep combination. It can add drowsiness, impaired coordination, memory problems and falls; disclose actual alcohol use for professional review." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "family-medicine-list-for-pharmacist", "dosage-forms-are-part-of-medicine-identity", "generic-drugs-and-bioequivalence" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/belsomra-suvorexant/", "en": "https://origindrug.com/en/drugs/belsomra-suvorexant/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "dayvigo-lemborexant", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-30", "status": "published_traceable_archive" }, "names": { "brand": "DAYVIGO", "generic": "莱博雷生", "aliases": [ "Dayvigo", "デエビゴ", "lemborexant", "莱博雷生", "レンボレキサント", "莱博雷生片", "DAYVIGO", "NDA 212028", "62856-405-30", "62856-405-90", "62856-410-30", "62856-410-90", "30200AMX00017000", "30200AMX00018000", "30200AMX00019000" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "精神健康", "sourceArchiveMarket": "美国 DAYVIGO 当前品牌标签 5/10 mg 的 30 片与 90 片瓶装；日本 PMDA 当前 デエビゴ 2.5/5/10 mg 三个产品身份、电子说明书和患者指南", "dosageFormClass": "口服薄膜衣片；美国 5 mg、10 mg，30 或 90 片瓶装，C-IV 管制药物；日本 2.5 mg、5 mg、10 mg。市场、强度、包装与标签必须分别阅读", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "2019（FDA NDA 212028）；日本 2020 批准产品", "archiveSponsorText": "Eisai Inc.（美国当前标签）；エーザイ株式会社（日本 PMDA）" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [ "DAYVIGO", "デエビゴ錠2.5mg", "デエビゴ錠5mg", "デエビゴ錠10mg" ], "excludedProductCues": [ "BELSOMRA", "suvorexant", "QUVIVIQ", "daridorexant", "AMBIEN", "zolpidem", "generic lemborexant", "other lemborexant product" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-dayvigo-lemborexant-5mg-30-tablet-bottle-ndc-6285640530", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（SPL v39；2025-02 更新）", "en": "Current U.S. DailyMed public label (SPL v39; updated Feb 2025)" }, "dosageForm": { "zh": "DAYVIGO 莱博雷生口服薄膜衣片", "en": "DAYVIGO lemborexant oral film-coated tablet" }, "route": { "zh": "口服；准确产品身份字段，不据此生成个人片数或服用时间", "en": "oral; exact product-identity field, not an individual tablet count or timing" }, "routeCodes": [ "oral" ], "productCode": "NDC 62856-405-30", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片莱博雷生 5 mg；30 片瓶装", "en": "Lemborexant 5 mg per tablet; 30-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=dayvigo-05.jpg&setid=7074cb65-77b3-45d2-8e8d-da8dc0f70bfd", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "莱博雷生", "en": "lemborexant" }, "value": 5, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、频次、补服、停药或换药指令", "en": "labelled amount per tablet; not an individual's tablet count, frequency, make-up, stopping or switching instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-30", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 30, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "淡黄色", "en": "pale yellow" }, "shape": { "zh": "圆形薄膜衣片；无刻痕", "en": "round film-coated tablet; unscored" }, "imprint": "5;LEM", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_02bc131fe45183ab", "label": "DailyMed（NLM）：DAYVIGO 5 mg、NDC 62856-405-30、30 片瓶装当前美国标签面板", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=7074cb65-77b3-45d2-8e8d-da8dc0f70bfd", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-dayvigo-lemborexant-5mg-90-tablet-bottle-ndc-6285640590", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（SPL v39；2025-02 更新）", "en": "Current U.S. DailyMed public label (SPL v39; updated Feb 2025)" }, "dosageForm": { "zh": "DAYVIGO 莱博雷生口服薄膜衣片", "en": "DAYVIGO lemborexant oral film-coated tablet" }, "route": { "zh": "口服；准确产品身份字段，不据此生成个人片数或服用时间", "en": "oral; exact product-identity field, not an individual tablet count or timing" }, "routeCodes": [ "oral" ], "productCode": "NDC 62856-405-90", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片莱博雷生 5 mg；90 片瓶装", "en": "Lemborexant 5 mg per tablet; 90-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=dayvigo-06.jpg&setid=7074cb65-77b3-45d2-8e8d-da8dc0f70bfd", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "莱博雷生", "en": "lemborexant" }, "value": 5, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、频次、补服、停药或换药指令", "en": "labelled amount per tablet; not an individual's tablet count, frequency, make-up, stopping or switching instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 90, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-30", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 90, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "淡黄色", "en": "pale yellow" }, "shape": { "zh": "圆形薄膜衣片；无刻痕", "en": "round film-coated tablet; unscored" }, "imprint": "5;LEM", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_02bc131fe45183ab", "label": "DailyMed（NLM）：DAYVIGO 5 mg、NDC 62856-405-90、90 片瓶装当前美国标签面板", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=7074cb65-77b3-45d2-8e8d-da8dc0f70bfd", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-dayvigo-lemborexant-10mg-30-tablet-bottle-ndc-6285641030", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（SPL v39；2025-02 更新）", "en": "Current U.S. DailyMed public label (SPL v39; updated Feb 2025)" }, "dosageForm": { "zh": "DAYVIGO 莱博雷生口服薄膜衣片", "en": "DAYVIGO lemborexant oral film-coated tablet" }, "route": { "zh": "口服；准确产品身份字段，不据此生成个人片数或服用时间", "en": "oral; exact product-identity field, not an individual tablet count or timing" }, "routeCodes": [ "oral" ], "productCode": "NDC 62856-410-30", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片莱博雷生 10 mg；30 片瓶装", "en": "Lemborexant 10 mg per tablet; 30-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=dayvigo-07.jpg&setid=7074cb65-77b3-45d2-8e8d-da8dc0f70bfd", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "莱博雷生", "en": "lemborexant" }, "value": 10, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、频次、补服、停药或换药指令", "en": "labelled amount per tablet; not an individual's tablet count, frequency, make-up, stopping or switching instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-30", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 30, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "橙色", "en": "orange" }, "shape": { "zh": "圆形薄膜衣片；无刻痕", "en": "round film-coated tablet; unscored" }, "imprint": "10;LEM", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_02bc131fe45183ab", "label": "DailyMed（NLM）：DAYVIGO 10 mg、NDC 62856-410-30、30 片瓶装当前美国标签面板", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=7074cb65-77b3-45d2-8e8d-da8dc0f70bfd", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-dayvigo-lemborexant-10mg-90-tablet-bottle-ndc-6285641090", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（SPL v39；2025-02 更新）", "en": "Current U.S. DailyMed public label (SPL v39; updated Feb 2025)" }, "dosageForm": { "zh": "DAYVIGO 莱博雷生口服薄膜衣片", "en": "DAYVIGO lemborexant oral film-coated tablet" }, "route": { "zh": "口服；准确产品身份字段，不据此生成个人片数或服用时间", "en": "oral; exact product-identity field, not an individual tablet count or timing" }, "routeCodes": [ "oral" ], "productCode": "NDC 62856-410-90", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片莱博雷生 10 mg；90 片瓶装", "en": "Lemborexant 10 mg per tablet; 90-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=dayvigo-08.jpg&setid=7074cb65-77b3-45d2-8e8d-da8dc0f70bfd", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "莱博雷生", "en": "lemborexant" }, "value": 10, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、频次、补服、停药或换药指令", "en": "labelled amount per tablet; not an individual's tablet count, frequency, make-up, stopping or switching instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 90, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-30", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 90, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "橙色", "en": "orange" }, "shape": { "zh": "圆形薄膜衣片；无刻痕", "en": "round film-coated tablet; unscored" }, "imprint": "10;LEM", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_02bc131fe45183ab", "label": "DailyMed（NLM）：DAYVIGO 10 mg、NDC 62856-410-90、90 片瓶装当前美国标签面板", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=7074cb65-77b3-45d2-8e8d-da8dc0f70bfd", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "jp-dayvigo-lemborexant-2-5mg-tablet-30200amx00017000", "marketCode": "JP", "labelVersion": { "zh": "PMDA 当前日本电子说明书（2025-12-10 修订；2026-08-30 核验）", "en": "Current Japanese PMDA electronic label (revised 10 Dec 2025; verified 30 Aug 2026)" }, "dosageForm": { "zh": "デエビゴ 莱博雷生口服薄膜衣片", "en": "DAYVIGO lemborexant oral film-coated tablet (Japan)" }, "route": { "zh": "口服（日本准确产品身份字段）", "en": "oral (exact Japanese product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "PMDA 30200AMX00017000", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片莱博雷生 2.5 mg；日本 PMDA 产品身份", "en": "Lemborexant 2.5 mg per tablet; Japanese PMDA product identity" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "莱博雷生（レンボレキサント）", "en": "lemborexant" }, "value": 2.5, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片日本标签标示量；不是个人片数、年龄对应方案或跨市场换算", "en": "Japanese labelled amount per tablet; not an individual's tablet count, age-based regimen or cross-market conversion" } } ], "concentration": null, "container": { "typeCode": "not_established", "typeLabel": { "zh": "准确包装数量未在本身份卡中建立", "en": "exact pack count not established in this identity card" }, "fill": null, "countPerPackage": null, "countUnit": null }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-30", "currentLabelDisplayed": true, "ndcDirectoryListed": false, "marketAvailability": "active_regulatory_record", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": null, "physicalClues": { "color": { "zh": "淡红色", "en": "pale red" }, "shape": { "zh": "圆形薄膜衣片；直径约 7.1 mm、厚约 3.3 mm；无刻痕", "en": "round film-coated tablet; about 7.1 mm diameter and 3.3 mm thick; unscored" }, "imprint": "LЄM 2.5", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_d6917cceba82f5d2", "label": "日本 PMDA：デエビゴ（莱博雷生）2.5/5/10 mg 当前专业产品记录、电子说明书与患者资料入口", "url": "https://www.pmda.go.jp/PmdaSearch/rdDetail/iyaku/1190027F1022_1?user=1", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_database_record", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "jp-dayvigo-lemborexant-5mg-tablet-30200amx00018000", "marketCode": "JP", "labelVersion": { "zh": "PMDA 当前日本电子说明书（2025-12-10 修订；2026-08-30 核验）", "en": "Current Japanese PMDA electronic label (revised 10 Dec 2025; verified 30 Aug 2026)" }, "dosageForm": { "zh": "デエビゴ 莱博雷生口服薄膜衣片", "en": "DAYVIGO lemborexant oral film-coated tablet (Japan)" }, "route": { "zh": "口服（日本准确产品身份字段）", "en": "oral (exact Japanese product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "PMDA 30200AMX00018000", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片莱博雷生 5 mg；日本 PMDA 产品身份", "en": "Lemborexant 5 mg per tablet; Japanese PMDA product identity" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "莱博雷生（レンボレキサント）", "en": "lemborexant" }, "value": 5, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片日本标签标示量；不是个人片数、年龄对应方案或跨市场换算", "en": "Japanese labelled amount per tablet; not an individual's tablet count, age-based regimen or cross-market conversion" } } ], "concentration": null, "container": { "typeCode": "not_established", "typeLabel": { "zh": "准确包装数量未在本身份卡中建立", "en": "exact pack count not established in this identity card" }, "fill": null, "countPerPackage": null, "countUnit": null }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-30", "currentLabelDisplayed": true, "ndcDirectoryListed": false, "marketAvailability": "active_regulatory_record", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": null, "physicalClues": { "color": { "zh": "微黄色", "en": "slightly yellow" }, "shape": { "zh": "圆形薄膜衣片；直径约 7.1 mm、厚约 3.3 mm；无刻痕", "en": "round film-coated tablet; about 7.1 mm diameter and 3.3 mm thick; unscored" }, "imprint": "LЄM 5", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_d6917cceba82f5d2", "label": "日本 PMDA：デエビゴ（莱博雷生）2.5/5/10 mg 当前专业产品记录、电子说明书与患者资料入口", "url": "https://www.pmda.go.jp/PmdaSearch/rdDetail/iyaku/1190027F1022_1?user=1", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_database_record", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "jp-dayvigo-lemborexant-10mg-tablet-30200amx00019000", "marketCode": "JP", "labelVersion": { "zh": "PMDA 当前日本电子说明书（2025-12-10 修订；2026-08-30 核验）", "en": "Current Japanese PMDA electronic label (revised 10 Dec 2025; verified 30 Aug 2026)" }, "dosageForm": { "zh": "デエビゴ 莱博雷生口服薄膜衣片", "en": "DAYVIGO lemborexant oral film-coated tablet (Japan)" }, "route": { "zh": "口服（日本准确产品身份字段）", "en": "oral (exact Japanese product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "PMDA 30200AMX00019000", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片莱博雷生 10 mg；日本 PMDA 产品身份", "en": "Lemborexant 10 mg per tablet; Japanese PMDA product identity" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "莱博雷生（レンボレキサント）", "en": "lemborexant" }, "value": 10, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片日本标签标示量；不是个人片数、年龄对应方案或跨市场换算", "en": "Japanese labelled amount per tablet; not an individual's tablet count, age-based regimen or cross-market conversion" } } ], "concentration": null, "container": { "typeCode": "not_established", "typeLabel": { "zh": "准确包装数量未在本身份卡中建立", "en": "exact pack count not established in this identity card" }, "fill": null, "countPerPackage": null, "countUnit": null }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-30", "currentLabelDisplayed": true, "ndcDirectoryListed": false, "marketAvailability": "active_regulatory_record", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": null, "physicalClues": { "color": { "zh": "橙色", "en": "orange" }, "shape": { "zh": "圆形薄膜衣片；直径约 7.1 mm、厚约 3.3 mm；无刻痕", "en": "round film-coated tablet; about 7.1 mm diameter and 3.3 mm thick; unscored" }, "imprint": "LЄM 10", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_d6917cceba82f5d2", "label": "日本 PMDA：デエビゴ（莱博雷生）2.5/5/10 mg 当前专业产品记录、电子说明书与患者资料入口", "url": "https://www.pmda.go.jp/PmdaSearch/rdDetail/iyaku/1190027F1022_1?user=1", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_database_record", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-dayvigo-lemborexant-5mg-30-tablet-bottle-ndc-6285640530", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=dayvigo-05.jpg&setid=7074cb65-77b3-45d2-8e8d-da8dc0f70bfd", "alt": "DAYVIGO 莱博雷生 5 mg、NDC 62856-405-30、30 片瓶装在美国 DailyMed 当前标签中的展示面", "archiveMarket": "美国", "labelVersion": "DailyMed SPL v39（2025-02 更新）", "presentation": "DAYVIGO 5 mg、NDC 62856-405-30、30 片瓶装标签展示面", "notice": "此图只对应美国当前标签中的 DAYVIGO 5 mg、NDC 62856-405-30、30 片瓶装。它不代表日本包装、BELSOMRA、QUVIVIQ、AMBIEN、通用药、库存或可购买资格，不用于鉴定真伪或生成个人服用安排。日本三种产品本页只保留 PMDA 文字身份，不借用美国包装图。", "source": { "id": "src_02bc131fe45183ab", "label": "DailyMed（NLM）：DAYVIGO 莱博雷生口服片当前美国公开标签、Medication Guide 与四个瓶装包装面板（SPL v39；2025-02 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=7074cb65-77b3-45d2-8e8d-da8dc0f70bfd", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "DAYVIGO 说明书放大阅读：先核对每片 mg，再看次日清醒、跌倒与完整药单", "en": "DAYVIGO label reading: check mg per tablet, next-day alertness, falls and the full medicine list" }, "summary": { "zh": "美国 5、10 mg 与日本 2.5、5、10 mg 是每片莱博雷生的标签标示量，不是网页给出的个人服用方案。酒精、阿片类、其他安眠镇静药和其他中枢抑制药可能叠加嗜睡、反应变慢、呼吸或跌倒风险。", "en": "U.S. 5 and 10 mg and Japanese 2.5, 5 and 10 mg figures are labelled lemborexant amounts per tablet, not a personal regimen supplied by this site. Alcohol, opioids, other sleep or sedative medicines and other CNS depressants can add drowsiness, slowed reactions, breathing or fall risk." }, "checks": [ { "zh": "包装上的 mg 只帮助识别强度，不等于应该吃几片。美国和日本的产品强度与标签文字不同；网页不会从年龄、失眠时长或市场自动生成个人片数、服用时间或漏服补服方案。", "en": "The pack mg identifies strength and is not a tablet count. U.S. and Japanese strengths and label wording differ; this site does not generate an individual tablet count, timing or missed-use action from age, insomnia duration or market." }, { "zh": "莱博雷生可能影响次日清醒、注意力、驾驶和运动协调。老人早晨仍明显困倦、站立不稳或发生跌倒时，不要驾车、操作危险设备、追加另一种安眠药或饮酒，应及时联系专业人员核对。", "en": "Lemborexant can affect next-day alertness, attention, driving and motor coordination. If an older adult remains markedly drowsy, unsteady on standing or has a fall, do not drive, operate hazardous equipment, add another sleep medicine or use alcohol; seek timely professional review." }, { "zh": "梦游、睡眠驾驶、在未完全清醒时进食、打电话或做其他事情属于复杂睡眠行为警讯。若发生，应先确保安全并立即联系开方团队；受伤、意识异常、呼吸困难或其他急性危险应使用当地急救支持。", "en": "Sleep-walking, sleep-driving, eating, making calls or other activities while not fully awake are complex-sleep-behaviour warnings. Secure safety and contact the prescriber immediately; injury, altered awareness, breathing difficulty or another acute danger requires local emergency support." }, { "zh": "睡眠瘫痪、入睡或醒来时出现幻觉样体验，或短暂腿部无力都应记录发生时间和同服药物并联系专业人员。网页不能用这些表现替个人诊断，也不能据此自行加量、减量或停药。", "en": "Sleep paralysis, hallucination-like experiences around sleep or waking, or temporary leg weakness should be recorded with timing and co-medications and reviewed professionally. The site cannot diagnose from these events or direct an individual increase, decrease or stop." }, { "zh": "酒精、阿片类、苯二氮䓬类、抗过敏药及其他中枢抑制药可能叠加风险；强或中度 CYP3A 抑制剂及诱导剂也会影响专业安排。请带上处方药、非处方药、保健品和完整药单逐项核对。", "en": "Alcohol, opioids, benzodiazepines, allergy medicines and other CNS depressants can add risk. Strong or moderate CYP3A inhibitors and inducers can also affect professional management. Bring prescription medicines, OTC products, supplements and the full list for item-by-item review." }, { "zh": "DAYVIGO、BELSOMRA 与 AMBIEN 是不同药物。即使都用于睡眠，或 DAYVIGO 与 BELSOMRA 同属双食欲素受体拮抗剂，也不能按 mg 换算、自行隔天轮换、叠加或用剩药替换。", "en": "DAYVIGO, BELSOMRA and AMBIEN are different medicines. Even though they may be used for sleep, and DAYVIGO and BELSOMRA are both dual orexin-receptor antagonists, they cannot be converted by mg, self-rotated on alternate days, combined or substituted with leftovers." } ], "source": { "id": "src_02bc131fe45183ab", "label": "DailyMed（NLM）：DAYVIGO 莱博雷生口服片当前美国公开标签、Medication Guide 与四个瓶装包装面板（SPL v39；2025-02 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=7074cb65-77b3-45d2-8e8d-da8dc0f70bfd", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "莱博雷生怎样作用：阻断 OX1R 与 OX2R 食欲素受体，减弱促清醒信号", "en": "How lemborexant works: blocking OX1R and OX2R orexin receptors to reduce wake signalling" }, "summary": { "zh": "莱博雷生是双食欲素受体拮抗剂，可结合 OX1R 与 OX2R，抑制食欲素系统的促清醒信号。通俗地说，它减弱一条维持清醒的信号，而不是把所有神经活动‘关掉’；这个机制不能预测个人是否适合、应选多少 mg 或能否与其他安眠镇静药叠加。", "en": "Lemborexant is a dual orexin-receptor antagonist that binds OX1R and OX2R and suppresses wake-promoting orexin signalling. In plain language, it reduces one wake-maintaining signal rather than ‘switching off’ all brain activity. This mechanism cannot predict individual suitability, strength choice or safe combination with another sleep or sedative medicine." }, "checks": [ { "zh": "同属双食欲素受体拮抗剂不表示 DAYVIGO、BELSOMRA 与 QUVIVIQ 是同一种药，也不允许按毫克数一比一替换、叠加或轮换。", "en": "Membership in the dual orexin-receptor-antagonist class does not make DAYVIGO, BELSOMRA and QUVIVIQ one medicine or permit one-for-one milligram substitution, combination or rotation." }, { "zh": "与 AMBIEN 等其他作用机制的睡眠药不同，也不表示哪一种对所有人更好。完整药单、次日活动需求、跌倒与呼吸风险及专业评估都会影响个人安排。", "en": "A different mechanism from AMBIEN and other sleep medicines does not make one better for everyone. The full medicine list, next-day activity needs, fall and breathing risks and professional assessment can all affect individual management." }, { "zh": "机制用于理解药理和相互作用边界，不用于从睡眠时长或症状自行诊断病因、选药、决定片数或忽略次日困倦与复杂睡眠行为等完整标签警示。", "en": "Mechanism helps explain pharmacology and interaction boundaries; it does not diagnose the cause from sleep duration or symptoms, select treatment, set a tablet count or displace full label warnings such as next-day drowsiness and complex sleep behaviours." } ], "source": { "id": "src_02bc131fe45183ab", "label": "DailyMed（NLM）：DAYVIGO 莱博雷生口服片当前美国公开标签、Medication Guide 与四个瓶装包装面板（SPL v39；2025-02 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=7074cb65-77b3-45d2-8e8d-da8dc0f70bfd", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "DAYVIGO", "generic": "莱博雷生", "dosageFormClass": "口服薄膜衣片；美国 5 mg、10 mg，30 或 90 片瓶装，C-IV 管制药物；日本 2.5 mg、5 mg、10 mg。市场、强度、包装与标签必须分别阅读" }, "labelSource": { "id": "src_02bc131fe45183ab", "label": "DailyMed（NLM）：DAYVIGO 莱博雷生口服片当前美国公开标签、Medication Guide 与四个瓶装包装面板（SPL v39；2025-02 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=7074cb65-77b3-45d2-8e8d-da8dc0f70bfd", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "productRoutes": [ { "source": { "id": "src_02bc131fe45183ab", "label": "DailyMed（NLM）：DAYVIGO 莱博雷生口服片当前美国公开标签、Medication Guide 与四个瓶装包装面板（SPL v39；2025-02 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=7074cb65-77b3-45d2-8e8d-da8dc0f70bfd", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-30", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_28bcb721fcadb9cd", "label": "日本 PMDA：デエビゴ 2.5/5/10 mg 当前电子说明书（2025-12-10 修订）", "url": "https://www.pmda.go.jp/PmdaSearch/iyakuDetail/ResultDataSetPDF/170033_1190027F1022_1_08", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "status": "product_level_public_record_verified", "authority": { "zh": "PMDA", "en": "PMDA" }, "market": { "zh": "日本", "en": "Japan" }, "recordType": { "zh": "监管产品记录", "en": "Regulatory product record" }, "reviewedAt": "2026-08-30", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-30", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "DAYVIGO 是莱博雷生口服片的美国品牌，日本使用デエビゴ。美国当前标签展示 5、10 mg 的 30 片与 90 片瓶装。本页优先帮助老人和家属核对每片 mg、次日清醒与驾驶、嗜睡跌倒、复杂睡眠行为、酒精及其他中枢抑制药、CYP3A 相互作用；不生成个人片数、服用时间、补服、停药或换药方案。", "history": "FDA 于 2019 年批准 NDA 212028；美国当前标签将 DAYVIGO 列为 C-IV 管制药物。日本 PMDA 当前记录列 2.5、5、10 mg 产品并提供专业说明书和患者指南。批准史和各市场强度差异不能作为跨市场自行选规格或换算片数的依据。", "sourceDocuments": [ { "id": "src_02bc131fe45183ab", "label": "DailyMed（NLM）：DAYVIGO 莱博雷生口服片当前美国公开标签、Medication Guide 与四个瓶装包装面板（SPL v39；2025-02 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=7074cb65-77b3-45d2-8e8d-da8dc0f70bfd", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, { "id": "src_b349d6bcc5f44eb8", "label": "FDA：DAYVIGO（lemborexant）NDA 212028 初始批准函（2019）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/212028Orig1s000Approv.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "regulatory_decision", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, { "id": "src_694bcc8d39732179", "label": "FDA：DAYVIGO 莱博雷生 NDA 212028 多学科审评资料", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/212028Orig1s000MultidisciplineR.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "regulatory_review", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, { "id": "src_13c9750dcadf9a09", "label": "FDA：DAYVIGO NDA 212028/S-008 补充批准函（2023）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/212028Orig1s008ltr.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "regulatory_decision", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, { "id": "src_d6917cceba82f5d2", "label": "日本 PMDA：デエビゴ（莱博雷生）2.5/5/10 mg 当前专业产品记录、电子说明书与患者资料入口", "url": "https://www.pmda.go.jp/PmdaSearch/rdDetail/iyaku/1190027F1022_1?user=1", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_database_record", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, { "id": "src_28bcb721fcadb9cd", "label": "日本 PMDA：デエビゴ 2.5/5/10 mg 当前电子说明书（2025-12-10 修订）", "url": "https://www.pmda.go.jp/PmdaSearch/iyakuDetail/ResultDataSetPDF/170033_1190027F1022_1_08", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, { "id": "src_ded1021170e392dd", "label": "日本 PMDA：デエビゴ 2.5/5/10 mg 患者向医药品指南", "url": "https://www.info.pmda.go.jp/downfiles/ph/GUI/170033_1190027F1022_1_00G.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "consumer_medicine_information", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, { "id": "src_ac995c69dc1381b5", "label": "日本 PMDA：デエビゴ（lemborexant）新药审评报告", "url": "https://www.pmda.go.jp/drugs/2020/P20200203001/170033000_30200AMX00017_A100_1.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "regulatory_review", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" } ], "applicationNumber": "FDA NDA 212028（DAYVIGO / lemborexant tablets）；日本 PMDA 1190027F1022", "approvalTimeline": [ { "date": "2019-12", "title": { "zh": "美国 NDA 212028 初始批准", "en": "Initial U.S. NDA 212028 approval" }, "detail": { "zh": "FDA 批准记录把 DAYVIGO、莱博雷生和 Eisai 相连；批准不等于任何地点的实时库存或个人适用性。", "en": "The FDA approval record links DAYVIGO, lemborexant and Eisai. Approval does not establish real-time local stock or individual suitability." }, "source": { "id": "src_b349d6bcc5f44eb8", "label": "FDA：DAYVIGO（lemborexant）NDA 212028 初始批准函（2019）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/212028Orig1s000Approv.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "regulatory_decision", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" } }, { "date": "2020", "title": { "zh": "日本 デエビゴ 产品批准", "en": "Japanese DAYVIGO product approvals" }, "detail": { "zh": "PMDA 当前记录列 2.5、5、10 mg 三个产品；日本强度和文字不能自动套用到美国或其他市场。", "en": "Current PMDA records list 2.5, 5 and 10 mg products. Japanese strengths and wording do not automatically transfer to the United States or another market." }, "source": { "id": "src_d6917cceba82f5d2", "label": "日本 PMDA：デエビゴ（莱博雷生）2.5/5/10 mg 当前专业产品记录、电子说明书与患者资料入口", "url": "https://www.pmda.go.jp/PmdaSearch/rdDetail/iyaku/1190027F1022_1?user=1", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_database_record", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" } }, { "date": "2025-02", "title": { "zh": "美国 DailyMed SPL v39 更新", "en": "U.S. DailyMed SPL v39 update" }, "detail": { "zh": "当前公开标签展示四个准确瓶装面板、Medication Guide 与安全文字。", "en": "The current public label displays four exact bottle panels, a Medication Guide and safety wording." }, "source": { "id": "src_02bc131fe45183ab", "label": "DailyMed（NLM）：DAYVIGO 莱博雷生口服片当前美国公开标签、Medication Guide 与四个瓶装包装面板（SPL v39；2025-02 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=7074cb65-77b3-45d2-8e8d-da8dc0f70bfd", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "当前品牌标签与四个准确瓶装已链接", "en": "Current brand label and four exact bottles linked" }, "detail": { "zh": "本页列 5/10 mg 的 30/90 片瓶装；不证明药店库存、购买资格或个人适用性。", "en": "The page lists 5/10 mg in 30/90-tablet bottles; it does not establish pharmacy stock, purchase eligibility or individual suitability." } }, { "market": { "zh": "日本", "en": "Japan" }, "status": { "zh": "当前 2.5/5/10 mg 产品、电子说明书与患者指南已链接；暂无准确包装图", "en": "Current 2.5/5/10 mg products, electronic label and patient guide linked; no exact package image established" }, "detail": { "zh": "三张日本身份卡只用 PMDA 文字，不借用美国包装图。", "en": "The three Japanese identity cards use PMDA text only and do not borrow U.S. pack images." } }, { "market": { "zh": "中国大陆及其他市场", "en": "Mainland China and other markets" }, "status": { "zh": "待逐项建立现行市场记录", "en": "Current market record not established" }, "detail": { "zh": "不从美国或日本品牌、颜色、刻字或毫克数推定当地批准、供应、原研/仿制关系或可替代性。", "en": "No local approval, supply, originator/generic relationship or interchangeability is inferred from a U.S. or Japanese brand, colour, imprint or milligram number." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "DAYVIGO 与 BELSOMRA 是同一种药吗？", "en": "Are DAYVIGO and BELSOMRA the same medicine?" }, "answer": { "zh": "不是。DAYVIGO 含莱博雷生，BELSOMRA 含苏沃雷生。共同作用于食欲素受体不表示可以按 mg 自行替换、叠加或轮换。", "en": "No. DAYVIGO contains lemborexant and BELSOMRA contains suvorexant. Shared orexin-receptor activity does not permit self-substitution, combination or rotation by milligrams." } }, { "question": { "zh": "老人早晨很困或跌倒，还能自己减半吗？", "en": "Can an older adult halve the tablet after morning drowsiness or a fall?" }, "answer": { "zh": "不要凭网页自行掰片、减量或停药。先避免驾驶和危险活动，记录实际药盒、发生时间、酒精及所有同服药，及时联系开方团队或药师；意识异常、严重受伤或呼吸困难应使用当地急救。", "en": "Do not self-split, reduce or stop from this page. Avoid driving and hazardous activity, record the actual pack, timing, alcohol and every co-medication, and contact the prescriber or pharmacist promptly. Altered awareness, serious injury or breathing difficulty requires local emergency help." } }, { "question": { "zh": "美国和日本都有 5 mg、10 mg，可以直接互换吗？", "en": "Can U.S. and Japanese 5 mg or 10 mg products be directly interchanged?" }, "answer": { "zh": "不能只凭共同毫克数判断。市场批准、处方、包装、辅料、供药体系和现行说明书都要分别核对；本页日本身份卡没有包装图，不能拿美国图片做真伪判断。", "en": "Not from a shared milligram figure. Market approval, prescription, pack, excipients, supply system and current label all require separate review. The Japanese identity cards have no package image here, so a U.S. image cannot authenticate them." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "family-medicine-list-for-pharmacist", "dosage-forms-are-part-of-medicine-identity", "how-to-read-a-drug-label" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/dayvigo-lemborexant/", "en": "https://origindrug.com/en/drugs/dayvigo-lemborexant/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "cleocin-hcl", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-28", "status": "published_traceable_archive" }, "names": { "brand": "CLEOCIN HCl", "generic": "盐酸克林霉素", "aliases": [ "Cleocin Hydrochloride", "盐酸克林霉素胶囊", "克林霉素胶囊", "clindamycin", "clindamycin hydrochloride", "盐酸克林霉素", "克林霉素", "0009-0331-02", "0009-0225-02", "0009-0395-14", "Cleocin 75 mg", "Cleocin 150 mg", "Cleocin 300 mg" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "感染", "sourceArchiveMarket": "美国 DailyMed 当前 CLEOCIN HCl 口服胶囊标签（2026-04-08 更新；2026-04-09 发布，SPL v40；NDA 050162）", "dosageFormClass": "盐酸克林霉素口服胶囊：每粒相当于克林霉素 75 mg、150 mg 或 300 mg；分别展示三个 100 粒瓶装面板", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "1970", "archiveSponsorText": "Pharmacia & Upjohn Company LLC（DailyMed 当前标签所列）" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [ "CLEOCIN PHOSPHATE", "CLEOCIN T", "CLEOCIN vaginal cream", "clindamycin phosphate injection" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-cleocin-hcl-clindamycin-75mg-100-capsule-bottle-ndc-0009-0331-02", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（2026-04-08 更新；2026-04-09 发布，SPL v40）", "en": "Current U.S. DailyMed public label (updated 8 Apr 2026; published 9 Apr 2026, SPL v40)" }, "dosageForm": { "zh": "CLEOCIN HCl 盐酸克林霉素口服胶囊", "en": "CLEOCIN HCl clindamycin hydrochloride oral capsule" }, "route": { "zh": "口服（准确胶囊产品身份字段）", "en": "oral (exact capsule-product identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 0009-0331-02", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_capsule", "primaryDisplay": { "zh": "每粒相当于克林霉素 75 mg；100 粒瓶装", "en": "Equivalent to clindamycin 75 mg per capsule; 100-capsule bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=cleocin-03.jpg&setid=df9a2a41-b132-4f43-8940-b2d773b1369a&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "克林霉素（以盐酸克林霉素提供）", "en": "clindamycin (supplied as clindamycin hydrochloride)" }, "value": 75, "unit": "mg", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒标签标示量；不是个人粒数、频率、疗程或补服指令", "en": "labelled amount per capsule; not an individual's capsule count, frequency, course or missed-use instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-28", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "physicalClues": { "color": { "zh": "绿色", "en": "green" }, "shape": { "zh": "胶囊，约 16 mm，无刻痕", "en": "capsule, approximately 16 mm, unscored" }, "imprint": "Cleocin / 75 / mg", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_7dabd1a29cb7aa16", "label": "DailyMed（NLM）：CLEOCIN HCl 75 mg、NDC 0009-0331-02、100 粒瓶装美国标签面板", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=df9a2a41-b132-4f43-8940-b2d773b1369a", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-cleocin-hcl-clindamycin-150mg-100-capsule-bottle-ndc-0009-0225-02", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（2026-04-08 更新；2026-04-09 发布，SPL v40）", "en": "Current U.S. DailyMed public label (updated 8 Apr 2026; published 9 Apr 2026, SPL v40)" }, "dosageForm": { "zh": "CLEOCIN HCl 盐酸克林霉素口服胶囊", "en": "CLEOCIN HCl clindamycin hydrochloride oral capsule" }, "route": { "zh": "口服（准确胶囊产品身份字段）", "en": "oral (exact capsule-product identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 0009-0225-02", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_capsule", "primaryDisplay": { "zh": "每粒相当于克林霉素 150 mg；100 粒瓶装", "en": "Equivalent to clindamycin 150 mg per capsule; 100-capsule bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=cleocin-04.jpg&setid=df9a2a41-b132-4f43-8940-b2d773b1369a&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "克林霉素（以盐酸克林霉素提供）", "en": "clindamycin (supplied as clindamycin hydrochloride)" }, "value": 150, "unit": "mg", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒标签标示量；不是个人粒数、频率、疗程或补服指令", "en": "labelled amount per capsule; not an individual's capsule count, frequency, course or missed-use instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-28", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "physicalClues": { "color": { "zh": "浅蓝色与绿色", "en": "light blue and green" }, "shape": { "zh": "胶囊，约 19 mm，无刻痕", "en": "capsule, approximately 19 mm, unscored" }, "imprint": "Cleocin / 150 / mg", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_7dabd1a29cb7aa16", "label": "DailyMed（NLM）：CLEOCIN HCl 150 mg、NDC 0009-0225-02、100 粒瓶装美国标签面板", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=df9a2a41-b132-4f43-8940-b2d773b1369a", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-cleocin-hcl-clindamycin-300mg-100-capsule-bottle-ndc-0009-0395-14", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（2026-04-08 更新；2026-04-09 发布，SPL v40）", "en": "Current U.S. DailyMed public label (updated 8 Apr 2026; published 9 Apr 2026, SPL v40)" }, "dosageForm": { "zh": "CLEOCIN HCl 盐酸克林霉素口服胶囊", "en": "CLEOCIN HCl clindamycin hydrochloride oral capsule" }, "route": { "zh": "口服（准确胶囊产品身份字段）", "en": "oral (exact capsule-product identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 0009-0395-14", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_capsule", "primaryDisplay": { "zh": "每粒相当于克林霉素 300 mg；100 粒瓶装", "en": "Equivalent to clindamycin 300 mg per capsule; 100-capsule bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=cleocin-05.jpg&setid=df9a2a41-b132-4f43-8940-b2d773b1369a&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "克林霉素（以盐酸克林霉素提供）", "en": "clindamycin (supplied as clindamycin hydrochloride)" }, "value": 300, "unit": "mg", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒标签标示量；不是个人粒数、频率、疗程或补服指令", "en": "labelled amount per capsule; not an individual's capsule count, frequency, course or missed-use instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-28", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "physicalClues": { "color": { "zh": "浅蓝色", "en": "light blue" }, "shape": { "zh": "胶囊，约 22 mm，无刻痕", "en": "capsule, approximately 22 mm, unscored" }, "imprint": "Cleocin / 300 / mg", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_7dabd1a29cb7aa16", "label": "DailyMed（NLM）：CLEOCIN HCl 300 mg、NDC 0009-0395-14、100 粒瓶装美国标签面板", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=df9a2a41-b132-4f43-8940-b2d773b1369a", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-cleocin-hcl-clindamycin-150mg-100-capsule-bottle-ndc-0009-0225-02", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=cleocin-04.jpg&setid=df9a2a41-b132-4f43-8940-b2d773b1369a&type=img", "alt": "CLEOCIN HCl 盐酸克林霉素 150 mg、100 粒瓶装在美国 DailyMed 当前标签中的主展示面", "archiveMarket": "美国", "labelVersion": "DailyMed SPL v40（2026-04-09 发布）", "presentation": "CLEOCIN HCl 150 mg、NDC 0009-0225-02、100 粒瓶装主展示面", "notice": "此图只对应当前美国标签中的一个准确 150 mg、100 粒瓶装面板，用于核对品牌、通用名、每粒标示量、NDC 与包装数量；不用于鉴定真伪，也不证明另一规格、剂型、包装、市场、库存、购买资格或可替代性。", "source": { "id": "src_7dabd1a29cb7aa16", "label": "DailyMed（NLM）：CLEOCIN HCl 盐酸克林霉素口服胶囊当前美国公开标签（Pharmacia & Upjohn；SPL v40）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=df9a2a41-b132-4f43-8940-b2d773b1369a", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "CLEOCIN HCl 说明书放大阅读：先分清每粒 mg、胶囊和严重腹泻警示", "en": "CLEOCIN HCl label reading: separate mg per capsule, the capsule form and the serious-diarrhoea warning" }, "summary": { "zh": "当前美国标签设有黑框警示，并分别列出 75、150、300 mg 口服胶囊。本模块帮助普通读者识别准确产品、找到需要立即求助的症状，并把个人问题带回处方和专业复核；不提供个人粒数、间隔或疗程。", "en": "The current U.S. label has a boxed warning and separately lists 75, 150 and 300 mg oral capsules. This module helps ordinary readers identify the exact product, recognise symptoms requiring prompt help and return individual questions to the prescription and professional review; it gives no personal capsule count, interval or course." }, "checks": [ { "zh": "75、150、300 mg 是每粒胶囊中相当于克林霉素的标签标示量，不是一天几粒，也不能只看总毫克数自行拿多粒小规格替代大规格、掰开胶囊或拼接疗程。", "en": "75, 150 and 300 mg are the labelled clindamycin-equivalent amounts per capsule. They do not state capsules per day and do not permit self-substituting several smaller capsules for a larger one, opening a capsule or assembling a course from a total milligram number." }, { "zh": "当前标签要求胶囊用一整杯水送服，并在躺下前至少留出 30 分钟，以降低食管刺激风险。网页只转述这一产品级标签阅读点；若吞咽困难、使用方法不清楚或实际产品不同，应先联系药师或开方团队。", "en": "The current label says to take the capsules with a full glass of water and at least 30 minutes before lying down to reduce oesophageal irritation. The site only relays this product-level label point; swallowing difficulty, uncertainty or a different product requires pharmacist or prescriber review first." }, { "zh": "标签的黑框警示说明艰难梭菌相关腹泻可发生并可能严重，症状也可能在抗菌药使用结束后出现。严重、持续或带血腹泻，明显腹痛、发热、脱水、虚弱或其他急性严重不适需要尽快使用当地医疗支持；不要自行用止泻药掩盖。", "en": "The boxed warning explains that C. difficile-associated diarrhoea can occur, may be severe and can appear after antibacterial treatment has ended. Severe, persistent or bloody diarrhoea, marked abdominal pain, fever, dehydration, weakness or another acute serious concern needs prompt local medical care; do not self-use an antidiarrhoeal medicine to mask it." }, { "zh": "CLEOCIN HCl 口服胶囊、CLEOCIN PHOSPHATE 注射剂、CLEOCIN T 外用产品和阴道用产品的成分表示、剂型、途径与标签不同；名称相近不能证明可以互换、叠加或改用。", "en": "CLEOCIN HCl oral capsules, CLEOCIN PHOSPHATE injections, CLEOCIN T topical products and vaginal products have different ingredient wording, forms, routes and labels. Similar names do not establish interchangeability, co-use or switching." } ], "source": { "id": "src_7dabd1a29cb7aa16", "label": "DailyMed（NLM）：CLEOCIN HCl 盐酸克林霉素口服胶囊当前美国公开标签（Pharmacia & Upjohn；SPL v40）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=df9a2a41-b132-4f43-8940-b2d773b1369a", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "克林霉素怎样起作用：抑制细菌蛋白质合成，不等于对所有感染都有效", "en": "How clindamycin works: inhibiting bacterial protein synthesis does not mean it treats every infection" }, "summary": { "zh": "当前美国标签的微生物学部分说明，克林霉素与细菌核糖体 50S 亚基结合并抑制蛋白质合成。机制用于解释药物类别，不能仅凭症状判断感染原因、是否敏感、该不该使用或需要多长疗程。", "en": "The microbiology section of the current U.S. label states that clindamycin binds to the bacterial 50S ribosomal subunit and inhibits protein synthesis. This explains the drug class; symptoms alone cannot identify the cause, susceptibility, whether it should be used or for how long." }, "checks": [ { "zh": "抗菌药不治疗普通病毒性感冒。相似的发热、咳嗽、咽痛、牙痛或皮肤不适可能有不同原因，不应拿剩药、与家人共用、交替吃或自行拼疗程。", "en": "Antibacterials do not treat an ordinary viral cold. Similar fever, cough, sore throat, dental pain or skin symptoms can have different causes, so do not use leftovers, share, alternate products or assemble a course yourself." }, { "zh": "标签提示克林霉素与某些药物存在代谢或药效相互作用。网页不从药名列表自动决定能否同服；应把处方药、非处方药、止泻药、补充剂、过敏史和既往严重腹泻一起交给药师或开方团队核对。", "en": "The label notes metabolic or pharmacologic interactions with some medicines. The site does not decide co-use from a name list; give the pharmacist or prescriber all prescriptions, OTC products, antidiarrhoeals, supplements, allergies and any history of severe diarrhoea for review." }, { "zh": "机制相同或同属抗菌药不表示 CLEOCIN HCl 可以与阿莫西林、阿奇霉素、左氧氟沙星或其他抗菌药自行替换、叠加或轮换；准确病原、敏感性、感染部位、器官功能和完整药单都可能改变专业判断。", "en": "A shared mechanism or antibacterial category does not make CLEOCIN HCl self-switchable, combinable or alternatable with amoxicillin, azithromycin, levofloxacin or another antibacterial. The organism, susceptibility, infection site, organ function and complete medicine list can all change professional decisions." } ], "source": { "id": "src_7dabd1a29cb7aa16", "label": "DailyMed（NLM）：CLEOCIN HCl 盐酸克林霉素口服胶囊当前美国公开标签（Pharmacia & Upjohn；SPL v40）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=df9a2a41-b132-4f43-8940-b2d773b1369a", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "CLEOCIN HCl", "generic": "盐酸克林霉素", "dosageFormClass": "盐酸克林霉素口服胶囊：每粒相当于克林霉素 75 mg、150 mg 或 300 mg；分别展示三个 100 粒瓶装面板" }, "labelSource": { "id": "src_7dabd1a29cb7aa16", "label": "DailyMed（NLM）：CLEOCIN HCl 盐酸克林霉素口服胶囊当前美国公开标签（Pharmacia & Upjohn；SPL v40）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=df9a2a41-b132-4f43-8940-b2d773b1369a", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" }, "productRoutes": [ { "source": { "id": "src_7dabd1a29cb7aa16", "label": "DailyMed（NLM）：CLEOCIN HCl 盐酸克林霉素口服胶囊当前美国公开标签（Pharmacia & Upjohn；SPL v40）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=df9a2a41-b132-4f43-8940-b2d773b1369a", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-28", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-28", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "CLEOCIN HCl 当前美国公开标签列有 75 mg、150 mg、300 mg 三种口服胶囊。本档案把每粒标示量、NDC、颜色、刻字、包装面板、黑框警示和吞服注意放在一起放大阅读；不把包装上的 mg 变成任何人的粒数、频率或疗程。", "history": "DailyMed 当前标签把 CLEOCIN HCl 与 NDA 050162 及 1970-05-22 的美国营销起始记录相连。这里的年份只定位美国监管档案；CLEOCIN PHOSPHATE 注射剂、CLEOCIN T 外用产品及阴道用产品是不同剂型和途径，不并入本口服胶囊档案。", "sourceDocuments": [ { "id": "src_7dabd1a29cb7aa16", "label": "DailyMed（NLM）：CLEOCIN HCl 盐酸克林霉素口服胶囊当前美国公开标签（Pharmacia & Upjohn；SPL v40）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=df9a2a41-b132-4f43-8940-b2d773b1369a", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" } ], "applicationNumber": "NDA 050162（CLEOCIN HCl / clindamycin hydrochloride oral capsules）", "approvalTimeline": [ { "date": "1970-05-22", "title": { "zh": "当前 DailyMed 产品记录所列美国 NDA 营销起始节点", "en": "U.S. NDA marketing-start node listed in the current DailyMed product record" }, "detail": { "zh": "当前标签的三个胶囊产品表均列出 NDA 050162 与 1970-05-22 营销起始日期。该节点只定位这一美国口服胶囊档案，不建立其他市场的批准、供应、原研/仿制关系或个人适用性。", "en": "All three capsule product tables in the current label list NDA 050162 and a marketing start date of 22 May 1970. This node locates this U.S. oral-capsule record only; it does not establish approval, supply, originator/generic relationship or individual suitability in another market." }, "source": { "id": "src_7dabd1a29cb7aa16", "label": "DailyMed（NLM）：CLEOCIN HCl 盐酸克林霉素口服胶囊当前美国公开标签（Pharmacia & Upjohn；SPL v40）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=df9a2a41-b132-4f43-8940-b2d773b1369a", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" } }, { "date": "2026-04-09", "title": { "zh": "DailyMed 当前 SPL v40 发布", "en": "Current DailyMed SPL v40 published" }, "detail": { "zh": "DailyMed 将当前标签的更新日期列为 2026-04-08，SPL v40 发布日期列为 2026-04-09。该日期定位文件版本；它不是任何人的开始用药日、频次、疗程或库存结论。", "en": "DailyMed lists the current label as updated 8 Apr 2026 and SPL v40 as published 9 Apr 2026. The date identifies the document version; it is not anyone's start date, frequency, course or a stock finding." }, "source": { "id": "src_7dabd1a29cb7aa16", "label": "DailyMed（NLM）：CLEOCIN HCl 盐酸克林霉素口服胶囊当前美国公开标签（Pharmacia & Upjohn；SPL v40）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=df9a2a41-b132-4f43-8940-b2d773b1369a", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "已链接当前口服胶囊标签和三个准确瓶装面板", "en": "Current oral-capsule label and three exact bottle panels linked" }, "detail": { "zh": "本页分别记录 75、150、300 mg 胶囊的 NDC、颜色、刻字与 100 粒瓶装面板。标签页面存在不等于任何地点有库存、可购买、适合个人或可以自行换规格。", "en": "The dossier separately records the NDC, colour, imprint and 100-capsule bottle panel for 75, 150 and 300 mg capsules. A label page does not establish local stock, purchase availability, individual suitability or self-switching between strengths." } }, { "market": { "zh": "中国大陆、欧盟、日本及其他市场", "en": "Mainland China, EU, Japan and other markets" }, "status": { "zh": "待逐项建立现行市场记录", "en": "Current market record not established" }, "detail": { "zh": "不从美国标签、品牌名、NDA、包装面板或共同通用名推定当地商品名、批准、包装、供应、可售资格、原研/仿制关系或可替代性。", "en": "No local trade name, approval, packaging, supply, sale eligibility, originator/generic relationship or interchangeability is inferred from the U.S. label, brand, NDA, package panel or shared generic name." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "包装写 150 mg，是否就表示一次吃一粒？", "en": "Does 150 mg on the pack mean one capsule per dose?" }, "answer": { "zh": "不是。150 mg 只是这粒准确胶囊中相当于克林霉素的标签标示量；个人粒数、频率、疗程与是否适用必须来自准确处方，并结合感染、过敏史、器官功能和完整药单由专业人员确认。", "en": "No. 150 mg is only the labelled clindamycin-equivalent amount in this exact capsule. Individual capsule count, frequency, course and suitability must come from the exact prescription and professional review of the infection, allergy history, organ function and complete medicine list." } }, { "question": { "zh": "胶囊太大，可以打开、倒出一半或混进食物吗？", "en": "If the capsule is too large, can it be opened, halved or mixed into food?" }, "answer": { "zh": "不要自行这样做。当前标签把 CLEOCIN HCl 定义为整粒口服胶囊，并强调足量水和躺下前间隔；页面没有证据把打开胶囊、目测分一半或混食物写成安全替代方法。请在改变前让药师或开方团队核对是否有适合的准确剂型和方案。", "en": "Do not do this yourself. The current label defines CLEOCIN HCl as an oral capsule and emphasises a full glass of water and time before lying down. The page has no evidence to present opening, visually halving or mixing the capsule as a safe alternative. Ask a pharmacist or prescriber to check an exact suitable form and plan before changing it." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "dosage-forms-are-part-of-medicine-identity", "how-to-read-a-drug-label" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/cleocin-hcl/", "en": "https://origindrug.com/en/drugs/cleocin-hcl/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "vibramycin", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-28", "status": "published_traceable_archive" }, "names": { "brand": "VIBRAMYCIN", "generic": "多西环素", "aliases": [ "Vibramycin Hyclate", "Vibramycin Monohydrate", "Vibramycin Calcium", "多西环素", "盐酸多西环素", "doxycycline", "doxycycline hyclate", "doxycycline monohydrate", "doxycycline calcium", "0069-0950-50", "0069-0970-65", "0069-0971-74", "VIBRA", "PFIZER 095" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "感染", "sourceArchiveMarket": "美国 DailyMed 当前 VIBRAMYCIN 公开标签（2026-05-13 生效，SPL v47）；标签明确说明全部所列剂型和强度目前均未上市销售", "dosageFormClass": "口服胶囊、复溶后口服混悬液用粉末及口服混悬液；三个产品的盐型、浓度基准和包装不同", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "1967", "archiveSponsorText": "Pfizer Laboratories Div Pfizer Inc（DailyMed 当前标签所列）" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [ "doxycycline injection", "intravenous doxycycline", "外用多西环素" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-vibramycin-hyclate-doxycycline-100mg-50-capsule-bottle-ndc-0069-0950-50", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（2026-05-13 生效，SPL v47）", "en": "Current U.S. DailyMed public label (effective 13 May 2026, SPL v47)" }, "dosageForm": { "zh": "VIBRAMYCIN Hyclate 盐酸多西环素胶囊", "en": "VIBRAMYCIN Hyclate doxycycline hyclate capsule" }, "route": { "zh": "口服（准确产品身份字段）", "en": "oral (exact-product identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 0069-0950-50", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_capsule", "primaryDisplay": { "zh": "每粒相当于多西环素 100 mg；50 粒瓶装", "en": "Equivalent to doxycycline 100 mg per capsule; 50-capsule bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=vibramycin-07.jpg&archiveid=964117", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "多西环素", "en": "doxycycline" }, "value": 100, "unit": "mg", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒标签标示量；不是个人粒数、频率或疗程", "en": "labelled amount per capsule; not an individual's capsule count, frequency or course" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": null, "countUnit": null }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-28", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "historical_discontinued_brand", "marketingStartDate": null, "marketingEndDate": "2024-11-30", "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": null, "physicalClues": { "color": { "zh": "浅蓝色", "en": "aqua blue" }, "shape": { "zh": "胶囊", "en": "capsule" }, "imprint": "VIBRA / PFIZER 095", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_9411e03133585355", "label": "DailyMed（NLM）：VIBRAMYCIN 每粒相当于多西环素 100 mg；50 粒瓶装、NDC 0069-0950-50 的美国标签身份字段；标签明确标为停止销售", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d6f98d3c-5a20-4cbf-9a9c-abef10b9e465", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-vibramycin-monohydrate-doxycycline-25mg-per-5ml-60ml-suspension-ndc-0069-0970-65", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（2026-05-13 生效，SPL v47）", "en": "Current U.S. DailyMed public label (effective 13 May 2026, SPL v47)" }, "dosageForm": { "zh": "VIBRAMYCIN Monohydrate 复溶后口服混悬液用粉末", "en": "VIBRAMYCIN Monohydrate powder for oral suspension" }, "route": { "zh": "口服（准确产品身份字段）", "en": "oral (exact-product identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 0069-0970-65", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_5_mL", "primaryDisplay": { "zh": "复溶后每 5 mL 含多西环素 25 mg；总量 60 mL", "en": "Doxycycline 25 mg per 5 mL after reconstitution; total volume 60 mL" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=vibramycin-03.jpg&archiveid=964117", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "多西环素", "en": "doxycycline" }, "value": 25, "unit": "mg", "basisCode": "per_5_mL", "basisLabel": { "zh": "每 5 mL 标签标示浓度；不是个人毫升数、频率或疗程", "en": "labelled concentration per 5 mL; not an individual's millilitres, frequency or course" } } ], "concentration": null, "container": { "typeCode": "bottle_after_reconstitution", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": null, "countUnit": null }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-28", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "historical_discontinued_brand", "marketingStartDate": null, "marketingEndDate": "2017-06-24", "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": null, "physicalClues": { "color": { "zh": "黄色粉末，复溶后为覆盆子味口服混悬液", "en": "yellow powder; raspberry-flavoured oral suspension after reconstitution" }, "shape": { "zh": "复溶用瓶装粉末", "en": "powder for reconstitution in bottle" }, "imprint": null, "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_9411e03133585355", "label": "DailyMed（NLM）：VIBRAMYCIN 复溶后每 5 mL 含多西环素 25 mg；总量 60 mL、NDC 0069-0970-65 的美国标签身份字段；标签明确标为停止销售", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d6f98d3c-5a20-4cbf-9a9c-abef10b9e465", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-vibramycin-calcium-doxycycline-50mg-per-5ml-473ml-suspension-ndc-0069-0971-74", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（2026-05-13 生效，SPL v47）", "en": "Current U.S. DailyMed public label (effective 13 May 2026, SPL v47)" }, "dosageForm": { "zh": "VIBRAMYCIN Calcium 多西环素钙口服混悬液（标签亦称 syrup）", "en": "VIBRAMYCIN Calcium doxycycline calcium oral suspension (also described as syrup in the label)" }, "route": { "zh": "口服（准确产品身份字段）", "en": "oral (exact-product identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 0069-0971-74", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_5_mL", "primaryDisplay": { "zh": "每 5 mL 含多西环素 50 mg；总量 473 mL", "en": "Doxycycline 50 mg per 5 mL; total volume 473 mL" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=vibramycin-06a.jpg&archiveid=964117", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "多西环素", "en": "doxycycline" }, "value": 50, "unit": "mg", "basisCode": "per_5_mL", "basisLabel": { "zh": "每 5 mL 标签标示浓度；不是个人毫升数、频率或疗程", "en": "labelled concentration per 5 mL; not an individual's millilitres, frequency or course" } } ], "concentration": null, "container": { "typeCode": "bottle_after_reconstitution", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": null, "countUnit": null }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-28", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "historical_discontinued_brand", "marketingStartDate": null, "marketingEndDate": "2023-08-31", "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": null, "physicalClues": { "color": { "zh": "覆盆子/苹果味口服混悬液", "en": "raspberry/apple-flavoured oral suspension" }, "shape": { "zh": "473 mL 瓶装液体", "en": "473 mL bottled liquid" }, "imprint": null, "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_9411e03133585355", "label": "DailyMed（NLM）：VIBRAMYCIN 每 5 mL 含多西环素 50 mg；总量 473 mL、NDC 0069-0971-74 的美国标签身份字段；标签明确标为停止销售", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d6f98d3c-5a20-4cbf-9a9c-abef10b9e465", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-vibramycin-hyclate-doxycycline-100mg-50-capsule-bottle-ndc-0069-0950-50", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=vibramycin-07.jpg&archiveid=964117", "alt": "VIBRAMYCIN Hyclate 100 mg、NDC 0069-0950-50、50 粒瓶装在 DailyMed 当前公开标签中的包装面板", "archiveMarket": "美国", "labelVersion": "DailyMed SPL v47（2026-05-13 生效）", "presentation": "VIBRAMYCIN Hyclate 100 mg 胶囊、NDC 0069-0950-50、50 粒瓶装历史产品面板", "notice": "此图只对应标签中的准确 100 mg 胶囊历史产品。标签明确标注 PRODUCT DISCONTINUED；图片不用于鉴定真伪，也不证明当前库存、可购买性、另一规格或另一市场状态。", "source": { "id": "src_9411e03133585355", "label": "DailyMed（NLM）：VIBRAMYCIN 多西环素当前美国公开标签（Pfizer；2026-05 修订，SPL v47）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d6f98d3c-5a20-4cbf-9a9c-abef10b9e465", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "VIBRAMYCIN 说明书放大阅读：先分清胶囊、液体浓度与停止销售状态", "en": "VIBRAMYCIN label reading: separate the capsule, liquid concentration and discontinued status" }, "summary": { "zh": "当前美国标签列有三个不同口服产品，但同时明确说明它们均已停止销售。页面帮助读者识别每粒与每 5 mL 的不同基准、需要尽快求助的严重症状及完整药单核对入口，不提供个人粒数、毫升数、间隔或疗程。", "en": "The current U.S. label lists three different oral products while explicitly stating that all are discontinued. This page helps distinguish per-capsule from per-5-mL quantities, identify serious symptoms requiring prompt help and prepare a complete medicine list for review; it gives no personal capsule count, millilitres, interval or course." }, "checks": [ { "zh": "100 mg 是每粒胶囊的标签标示量；25 mg/5 mL 和 50 mg/5 mL 是两种不同液体产品的浓度。三者不能只按数字自行换算、混用、替换或拼接疗程。", "en": "100 mg is the labelled amount per capsule; 25 mg/5 mL and 50 mg/5 mL are concentrations of two different liquid products. Do not self-convert, combine, substitute or assemble a course from these numbers." }, { "zh": "标签提示多西环素可能引起光敏反应、食管刺激或溃疡、严重皮肤反应、颅内高压及艰难梭菌相关腹泻。严重或迅速加重的症状、呼吸困难、面唇舌喉肿胀、广泛皮疹/水疱、视力变化、剧烈头痛、持续或带血腹泻等需要尽快使用当地急救或医疗支持。", "en": "The label warns about photosensitivity, oesophageal irritation or ulceration, severe skin reactions, intracranial hypertension and C. difficile-associated diarrhoea. Severe or rapidly worsening symptoms, breathing difficulty, swelling of the face/lips/tongue/throat, widespread rash or blisters, vision change, severe headache, or persistent/bloody diarrhoea require prompt local emergency or medical support." }, { "zh": "胶囊/片剂标签要求配足量液体吞服，以降低食管刺激和溃疡风险。若吞咽困难、实际产品不同或使用方式不清楚，应先让药师或开方团队核对准确说明书，不要自行打开胶囊或改用历史液体产品。", "en": "The capsule/tablet label calls for adequate fluid to reduce oesophageal irritation and ulceration. If swallowing is difficult, the actual product differs or instructions are unclear, ask a pharmacist or prescriber to check the exact label first; do not open a capsule or switch to a historical liquid product yourself." }, { "zh": "抗酸药、含铁/钙/镁/铝制品、其他处方药和补充剂都应列入完整药单交给药师核对。网页不根据药名列表生成同服间隔，也不替代处方。", "en": "Antacids, iron/calcium/magnesium/aluminium products, other prescriptions and supplements belong on the complete medicine list for pharmacist review. The site does not generate co-use spacing from a name list and does not replace the prescription." } ], "source": { "id": "src_9411e03133585355", "label": "DailyMed（NLM）：VIBRAMYCIN 多西环素当前美国公开标签（Pfizer；2026-05 修订，SPL v47）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d6f98d3c-5a20-4cbf-9a9c-abef10b9e465", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "多西环素怎样起作用：结合细菌 30S 核糖体亚基，抑制蛋白质合成", "en": "How doxycycline works: binding the bacterial 30S ribosomal subunit and inhibiting protein synthesis" }, "summary": { "zh": "当前标签的微生物学部分说明，多西环素通过结合细菌 30S 核糖体亚基抑制蛋白质合成，并具有抑菌活性。机制不能仅凭发热、咳嗽、咽痛或皮疹判断病因、敏感性、是否需要抗菌药或疗程。", "en": "The microbiology section of the current label states that doxycycline inhibits bacterial protein synthesis by binding the 30S ribosomal subunit and has bacteriostatic activity. The mechanism cannot determine the cause, susceptibility, need for an antibacterial or course from fever, cough, sore throat or rash alone." }, "checks": [ { "zh": "抗菌药不治疗普通病毒性感冒。不要使用剩药、与家人共用、因症状相似自行启动或提前停止。", "en": "Antibacterials do not treat an ordinary viral cold. Do not use leftovers, share with family, start because symptoms look similar or stop early on your own." }, { "zh": "同属四环素类、同为多西环素或毫克数相同，也不证明不同盐型、剂型、包装和市场产品可以自行替换。", "en": "A shared tetracycline class, doxycycline ingredient or milligram number does not prove that different salts, forms, packs and markets are self-interchangeable." }, { "zh": "机制段落不能替代培养、药敏、感染部位、年龄、妊娠哺乳状态、器官功能和完整药单的专业判断，也不能从网页自动生成个人疗程。", "en": "A mechanism paragraph cannot replace professional review of cultures, susceptibility, infection site, age, pregnancy or breastfeeding, organ function and the complete medicine list, and it cannot generate an individual course from this page." } ], "source": { "id": "src_9411e03133585355", "label": "DailyMed（NLM）：VIBRAMYCIN 多西环素当前美国公开标签（Pfizer；2026-05 修订，SPL v47）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d6f98d3c-5a20-4cbf-9a9c-abef10b9e465", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "VIBRAMYCIN", "generic": "多西环素", "dosageFormClass": "口服胶囊、复溶后口服混悬液用粉末及口服混悬液；三个产品的盐型、浓度基准和包装不同" }, "labelSource": { "id": "src_9411e03133585355", "label": "DailyMed（NLM）：VIBRAMYCIN 多西环素当前美国公开标签（Pfizer；2026-05 修订，SPL v47）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d6f98d3c-5a20-4cbf-9a9c-abef10b9e465", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" }, "productRoutes": [ { "source": { "id": "src_9411e03133585355", "label": "DailyMed（NLM）：VIBRAMYCIN 多西环素当前美国公开标签（Pfizer；2026-05 修订，SPL v47）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d6f98d3c-5a20-4cbf-9a9c-abef10b9e465", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-28", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_fe3a40ffffd88fab", "label": "DailyMed（NLM）：VIBRAMYCIN 当前美国公开标签 PDF", "url": "https://dailymed.nlm.nih.gov/dailymed/downloadpdffile.cfm?setId=d6f98d3c-5a20-4cbf-9a9c-abef10b9e465", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-28", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-28", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "VIBRAMYCIN 当前美国公开标签包含 100 mg 胶囊、25 mg/5 mL 复溶后混悬液和 50 mg/5 mL 口服混悬液三个准确产品记录，并明确标注全部产品已经停止销售。本页保留品牌、盐型、浓度基准、NDC、包装图和安全阅读点；不把历史标签误写成当前库存，也不把 mg 或 mg/5 mL 变成个人服用量。", "history": "DailyMed 当前标签把 VIBRAMYCIN 三个口服产品分别连接到 1967 或 1974 年开始的美国 NDA 营销记录，并给出各自的营销结束日期。标签在 2026 年仍作为监管公开记录更新，不表示这些停止销售的品牌产品重新上市。其他多西环素产品必须按申请号、盐型、剂型、强度和市场另行核验。", "sourceDocuments": [ { "id": "src_9411e03133585355", "label": "DailyMed（NLM）：VIBRAMYCIN 多西环素当前美国公开标签（Pfizer；2026-05 修订，SPL v47）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d6f98d3c-5a20-4cbf-9a9c-abef10b9e465", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" }, { "id": "src_fe3a40ffffd88fab", "label": "DailyMed（NLM）：VIBRAMYCIN 当前美国公开标签 PDF", "url": "https://dailymed.nlm.nih.gov/dailymed/downloadpdffile.cfm?setId=d6f98d3c-5a20-4cbf-9a9c-abef10b9e465", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" } ], "applicationNumber": "NDA 050007 / 050006 / 050480（VIBRAMYCIN 三个停止销售的美国口服产品记录）", "approvalTimeline": [ { "date": "1967-12-05", "title": { "zh": "VIBRAMYCIN Hyclate 胶囊美国营销起始记录", "en": "U.S. marketing-start record for VIBRAMYCIN Hyclate capsules" }, "detail": { "zh": "当前标签产品表把 100 mg 胶囊与 NDA 050007 及该日期相连；营销结束日期列为 2024-11-30。", "en": "The current label product table links the 100 mg capsule to NDA 050007 and this date; it lists a marketing end date of 30 Nov 2024." }, "source": { "id": "src_9411e03133585355", "label": "DailyMed（NLM）：VIBRAMYCIN 多西环素当前美国公开标签（Pfizer；2026-05 修订，SPL v47）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d6f98d3c-5a20-4cbf-9a9c-abef10b9e465", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" } }, { "date": "2026-05-13", "title": { "zh": "DailyMed 当前 SPL v47 生效", "en": "Current DailyMed SPL v47 effective" }, "detail": { "zh": "该日期定位当前公开文件版本。标签同时明确所有剂型与强度目前均未上市销售，因此文件更新不能被解释为产品重新供应。", "en": "This date identifies the current public document version. The label also explicitly states that all forms and strengths are not currently marketed, so the document update must not be read as renewed supply." }, "source": { "id": "src_9411e03133585355", "label": "DailyMed（NLM）：VIBRAMYCIN 多西环素当前美国公开标签（Pfizer；2026-05 修订，SPL v47）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d6f98d3c-5a20-4cbf-9a9c-abef10b9e465", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "当前公开标签存在；标签所列三个产品均已停止销售", "en": "Current public label exists; all three listed products are discontinued" }, "detail": { "zh": "标签保留三个 NDA、NDC、产品图和营销结束日期。它是可追溯的监管记录，不是库存、购买资格或重新上市结论。", "en": "The label retains three NDAs, NDCs, product images and marketing end dates. It is a traceable regulatory record, not a stock, purchase-eligibility or relaunch finding." } }, { "market": { "zh": "中国大陆、欧盟、日本及其他市场", "en": "Mainland China, EU, Japan and other markets" }, "status": { "zh": "待逐项建立现行市场记录", "en": "Current market record not established" }, "detail": { "zh": "不从美国历史品牌记录推定当地商品名、批准、包装、供应、原研/仿制关系或可替代性。", "en": "No local trade name, approval, packaging, supply, originator/generic relationship or interchangeability is inferred from the U.S. historical brand record." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "标签还在更新，是否表示 VIBRAMYCIN 现在还能买到？", "en": "If the label is still updated, does that mean VIBRAMYCIN is currently available?" }, "answer": { "zh": "不是。当前标签明确写明所有所列剂型和强度目前均未上市销售，并在产品表中列出营销结束日期。标签存在是监管档案事实，不是库存或购买结论。", "en": "No. The current label explicitly says that all listed forms and strengths are not currently marketed and gives marketing end dates in the product tables. The label's existence is a regulatory-record fact, not a stock or purchasing conclusion." } }, { "question": { "zh": "25 mg/5 mL 是否等于一次应该喝 5 mL？", "en": "Does 25 mg/5 mL mean a person should take 5 mL at one time?" }, "answer": { "zh": "不是。25 mg/5 mL 只表示复溶后液体的标签浓度；个人毫升数、频率和疗程必须来自准确处方并由专业人员核对。", "en": "No. 25 mg/5 mL only states the labelled concentration after reconstitution. Individual millilitres, frequency and course must come from the exact prescription and professional review." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "dosage-forms-are-part-of-medicine-identity", "how-to-read-a-drug-label" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/vibramycin/", "en": "https://origindrug.com/en/drugs/vibramycin/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "keflex", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-28", "status": "published_traceable_archive" }, "names": { "brand": "KEFLEX", "generic": "头孢氨苄", "aliases": [ "Keflex", "cephalexin", "cefalexin", "头孢氨苄胶囊", "头孢氨苄", "NDA 050405" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "感染", "sourceArchiveMarket": "美国 FDA 当前 KEFLEX 口服胶囊处方信息（NDA 050405；SUPPL-111；2026-08 修订）", "dosageFormClass": "头孢氨苄口服胶囊：每粒 250 mg、500 mg 或 750 mg；本档案分别记录四个当前美国瓶装身份", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "1971", "archiveSponsorText": "Pragma Pharmaceuticals, LLC（FDA 2026 当前标签所列）" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [ "cephalexin oral suspension", "头孢氨苄干混悬剂", "cephalexin tablet", "头孢氨苄片" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-keflex-cephalexin-250mg-100-capsule-bottle-ndc-5846301101", "marketCode": "US", "labelVersion": { "zh": "FDA 当前美国处方信息（2026-08 修订；SUPPL-111）", "en": "Current U.S. FDA prescribing information (revised Aug 2026; SUPPL-111)" }, "dosageForm": { "zh": "KEFLEX 头孢氨苄口服胶囊", "en": "KEFLEX cephalexin oral capsule" }, "route": { "zh": "口服（准确胶囊产品身份字段）", "en": "oral (exact capsule-product identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 58463-011-01", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_capsule", "primaryDisplay": { "zh": "每粒相当于头孢氨苄 250 mg；100 粒瓶装", "en": "Equivalent to cephalexin 250 mg per capsule; 100-capsule bottle" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "头孢氨苄（以头孢氨苄一水合物提供）", "en": "cephalexin (supplied as cephalexin monohydrate)" }, "value": 250, "unit": "mg", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒标签标示量；不是个人粒数、频率、疗程或补服指令", "en": "labelled amount per capsule; not an individual's capsule count, frequency, course or missed-use instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-28", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "physicalClues": { "color": { "zh": "白色与深绿色", "en": "white and dark green" }, "shape": { "zh": "胶囊；无刻痕", "en": "capsule; unscored" }, "imprint": "KEFLEX / 250 mg", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_0e5cb45564a6cc69", "label": "FDA：KEFLEX（头孢氨苄）口服胶囊当前美国处方信息（NDA 050405；2026-08 修订）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/050405s111lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_pdf", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-keflex-cephalexin-500mg-100-capsule-bottle-ndc-5846301201", "marketCode": "US", "labelVersion": { "zh": "FDA 当前美国处方信息（2026-08 修订；SUPPL-111）", "en": "Current U.S. FDA prescribing information (revised Aug 2026; SUPPL-111)" }, "dosageForm": { "zh": "KEFLEX 头孢氨苄口服胶囊", "en": "KEFLEX cephalexin oral capsule" }, "route": { "zh": "口服（准确胶囊产品身份字段）", "en": "oral (exact capsule-product identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 58463-012-01", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_capsule", "primaryDisplay": { "zh": "每粒相当于头孢氨苄 500 mg；100 粒瓶装", "en": "Equivalent to cephalexin 500 mg per capsule; 100-capsule bottle" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "头孢氨苄（以头孢氨苄一水合物提供）", "en": "cephalexin (supplied as cephalexin monohydrate)" }, "value": 500, "unit": "mg", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒标签标示量；不是个人粒数、频率、疗程或补服指令", "en": "labelled amount per capsule; not an individual's capsule count, frequency, course or missed-use instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-28", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "physicalClues": { "color": { "zh": "浅绿色与深绿色", "en": "light green and dark green" }, "shape": { "zh": "胶囊；无刻痕", "en": "capsule; unscored" }, "imprint": "KEFLEX / 500 mg", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_0e5cb45564a6cc69", "label": "FDA：KEFLEX（头孢氨苄）口服胶囊当前美国处方信息（NDA 050405；2026-08 修订）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/050405s111lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_pdf", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-keflex-cephalexin-750mg-50-capsule-bottle-ndc-5846301350", "marketCode": "US", "labelVersion": { "zh": "FDA 当前美国处方信息（2026-08 修订；SUPPL-111）", "en": "Current U.S. FDA prescribing information (revised Aug 2026; SUPPL-111)" }, "dosageForm": { "zh": "KEFLEX 头孢氨苄口服胶囊", "en": "KEFLEX cephalexin oral capsule" }, "route": { "zh": "口服（准确胶囊产品身份字段）", "en": "oral (exact capsule-product identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 58463-013-50", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_capsule", "primaryDisplay": { "zh": "每粒相当于头孢氨苄 750 mg；50 粒瓶装", "en": "Equivalent to cephalexin 750 mg per capsule; 50-capsule bottle" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "头孢氨苄（以头孢氨苄一水合物提供）", "en": "cephalexin (supplied as cephalexin monohydrate)" }, "value": 750, "unit": "mg", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒标签标示量；不是个人粒数、频率、疗程或补服指令", "en": "labelled amount per capsule; not an individual's capsule count, frequency, course or missed-use instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 50, "countUnit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-28", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 50, "unit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "physicalClues": { "color": { "zh": "深绿色", "en": "dark green" }, "shape": { "zh": "胶囊；无刻痕", "en": "capsule; unscored" }, "imprint": "KEFLEX / 750 mg", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_0e5cb45564a6cc69", "label": "FDA：KEFLEX（头孢氨苄）口服胶囊当前美国处方信息（NDA 050405；2026-08 修订）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/050405s111lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_pdf", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-keflex-cephalexin-750mg-20-capsule-bottle-ndc-5846301320", "marketCode": "US", "labelVersion": { "zh": "FDA 当前美国处方信息（2026-08 修订；SUPPL-111）", "en": "Current U.S. FDA prescribing information (revised Aug 2026; SUPPL-111)" }, "dosageForm": { "zh": "KEFLEX 头孢氨苄口服胶囊", "en": "KEFLEX cephalexin oral capsule" }, "route": { "zh": "口服（准确胶囊产品身份字段）", "en": "oral (exact capsule-product identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 58463-013-20", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_capsule", "primaryDisplay": { "zh": "每粒相当于头孢氨苄 750 mg；20 粒瓶装", "en": "Equivalent to cephalexin 750 mg per capsule; 20-capsule bottle" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "头孢氨苄（以头孢氨苄一水合物提供）", "en": "cephalexin (supplied as cephalexin monohydrate)" }, "value": 750, "unit": "mg", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒标签标示量；不是个人粒数、频率、疗程或补服指令", "en": "labelled amount per capsule; not an individual's capsule count, frequency, course or missed-use instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 20, "countUnit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-28", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 20, "unit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "physicalClues": { "color": { "zh": "深绿色", "en": "dark green" }, "shape": { "zh": "胶囊；无刻痕", "en": "capsule; unscored" }, "imprint": "KEFLEX / 750 mg", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_0e5cb45564a6cc69", "label": "FDA：KEFLEX（头孢氨苄）口服胶囊当前美国处方信息（NDA 050405；2026-08 修订）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/050405s111lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_pdf", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "status": "withheld_repackaged_or_non_exact_visual", "title": { "zh": "已核验当前标签中的颜色、刻字、强度、NDC 与包装数量，但没有把文字规格冒充为官方包装图片", "en": "Current label text verifies colour, imprint, strength, NDC and pack count, but text-only identity is not presented as an official package image" }, "summary": { "zh": "FDA 2026 当前标签提供 250 mg、500 mg、750 mg 胶囊的外观文字和四个瓶装 NDC，但本次没有取得与每个当前包装一一对应、可安全公开展示的官方主展示面。因此页面展示来源可追溯的文字身份和可放大说明书，不使用零售图、再包装图或历史图片代替当前 KEFLEX 包装。", "en": "The 2026 FDA label provides appearance text for 250, 500 and 750 mg capsules and four bottle NDCs, but this review did not obtain an official principal display panel safely matched one-to-one to each current pack. The page therefore shows source-traceable text identity and an enlarged label, without substituting retail, repackaged or historical imagery for a current KEFLEX pack." }, "source": { "id": "src_0e5cb45564a6cc69", "label": "FDA：KEFLEX（头孢氨苄）口服胶囊当前美国处方信息（NDA 050405；2026-08 修订）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/050405s111lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_pdf", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "KEFLEX 说明书放大阅读：先分清每粒 mg、胶囊与处方频次", "en": "KEFLEX label reading: separate mg per capsule, the capsule form and the prescribed schedule" }, "summary": { "zh": "FDA 2026 当前说明书分别列出 250、500、750 mg 口服胶囊。本模块帮助普通读者核对准确产品、过敏与严重腹泻警示、肾功能和相互作用问题；它不会给出个人粒数、间隔或疗程。", "en": "The current 2026 FDA label separately lists 250, 500 and 750 mg oral capsules. This module helps ordinary readers check the exact product, allergy and serious-diarrhoea warnings, kidney function and interaction questions; it gives no individual capsule count, interval or course." }, "checks": [ { "zh": "250、500、750 mg 是每粒胶囊所含头孢氨苄的标签标示量，不是一次吃几粒或一天吃几次。不能只看总毫克数自行用多粒小规格替代大规格、打开胶囊分一半、补服或拼接疗程。", "en": "250, 500 and 750 mg are the labelled cephalexin amounts per capsule, not capsules per dose or doses per day. Do not self-substitute several smaller capsules for a larger one, open and halve a capsule, make up a dose or assemble a course from a total milligram number." }, { "zh": "使用前需要把头孢菌素、青霉素或其他药物的既往过敏反应告诉开方团队。呼吸困难、面部或咽喉肿胀、广泛皮疹、晕厥或其他严重过敏表现需要立即使用当地急救服务。", "en": "Tell the prescriber about previous reactions to cephalosporins, penicillins or other medicines. Breathing difficulty, facial or throat swelling, widespread rash, fainting or another severe allergic feature requires immediate local emergency care." }, { "zh": "严重、持续或带血腹泻，明显腹痛、发热、脱水或虚弱可能需要尽快医疗评估；标签说明相关问题可能在抗菌药结束后出现。不要自行用止泻药掩盖严重症状。", "en": "Severe, persistent or bloody diarrhoea, marked abdominal pain, fever, dehydration or weakness may require prompt medical assessment; the label explains that this problem can appear after antibacterial treatment has ended. Do not self-use an antidiarrhoeal medicine to mask severe symptoms." }, { "zh": "老年人或肾功能受损者尤其需要让专业人员核对肾功能与处方；标签还列出与二甲双胍、丙磺舒以及部分尿糖检测有关的注意事项。网页不根据年龄、化验值或药名自动改变个人用法。", "en": "Older adults or people with impaired kidney function especially need professional review of kidney function and the prescription. The label also notes metformin, probenecid and some urine-glucose testing. The site does not change individual use from age, a laboratory value or a medicine name." } ], "source": { "id": "src_0e5cb45564a6cc69", "label": "FDA：KEFLEX（头孢氨苄）口服胶囊当前美国处方信息（NDA 050405；2026-08 修订）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/050405s111lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_pdf", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "头孢氨苄怎样起作用：抑制细菌细胞壁合成，不等于对所有感染都有效", "en": "How cephalexin works: inhibiting bacterial cell-wall synthesis does not mean it treats every infection" }, "summary": { "zh": "FDA 当前说明书说明头孢氨苄通过抑制细菌细胞壁合成发挥杀菌作用。机制只能帮助理解药物类别；不能仅凭发热、咳嗽、咽痛、尿路或皮肤症状决定是不是细菌感染、是否敏感、该不该使用或需要多长疗程。", "en": "The current FDA label explains that cephalexin is bactericidal through inhibition of bacterial cell-wall synthesis. The mechanism only helps explain the class; fever, cough, sore throat, urinary or skin symptoms alone cannot establish a bacterial cause, susceptibility, whether it should be used or for how long." }, "checks": [ { "zh": "抗菌药不治疗普通病毒性感冒。不要拿剩药、与家人共用、因症状相似就自行开始，或在感觉好转后自行缩短处方疗程。", "en": "Antibacterials do not treat an ordinary viral cold. Do not use leftovers, share, self-start because symptoms seem similar or shorten a prescribed course because you feel better." }, { "zh": "同属头孢菌素或都用于感染，不表示 KEFLEX 可以与阿莫西林、阿莫西林/克拉维酸、阿奇霉素、克林霉素或左氧氟沙星自行替换、轮换或叠加。", "en": "A cephalosporin class or infection-related use does not make KEFLEX self-switchable, alternatable or combinable with amoxicillin, amoxicillin/clavulanate, azithromycin, clindamycin or levofloxacin." }, { "zh": "准确病原、培养或药敏结果、感染部位、过敏史、肾功能、年龄和完整药单都可能影响专业判断；网页只帮助读懂说明书，不替个人选抗菌药。", "en": "The organism, culture or susceptibility result, infection site, allergy history, kidney function, age and complete medicine list can all affect professional judgement. The site helps read the label and does not select an antibacterial for an individual." } ], "source": { "id": "src_0e5cb45564a6cc69", "label": "FDA：KEFLEX（头孢氨苄）口服胶囊当前美国处方信息（NDA 050405；2026-08 修订）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/050405s111lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_pdf", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "KEFLEX", "generic": "头孢氨苄", "dosageFormClass": "头孢氨苄口服胶囊：每粒 250 mg、500 mg 或 750 mg；本档案分别记录四个当前美国瓶装身份" }, "labelSource": { "id": "src_0e5cb45564a6cc69", "label": "FDA：KEFLEX（头孢氨苄）口服胶囊当前美国处方信息（NDA 050405；2026-08 修订）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/050405s111lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_pdf", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" }, "productRoutes": [ { "source": { "id": "src_0e5cb45564a6cc69", "label": "FDA：KEFLEX（头孢氨苄）口服胶囊当前美国处方信息（NDA 050405；2026-08 修订）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/050405s111lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_pdf", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" }, "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-08-28", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-08-28", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "KEFLEX 是头孢氨苄口服胶囊品牌档案。FDA 2026 当前标签列有 250 mg、500 mg、750 mg 三种每粒强度和四个瓶装身份。本页把商品名、通用名、每粒 mg、NDC、外观文字、说明书和重要安全问题分开说明；不会从包装数字推算任何人的粒数、频率或疗程。", "history": "FDA 当前处方信息将 KEFLEX 的美国初始批准年份列为 1971，Drugs@FDA 当前申请页记录 NDA 050405 及 2026-08-03 的 SUPPL-111 标签。口服混悬剂、其他头孢氨苄剂型、其他厂牌或市场产品不并入这四个胶囊包装身份。", "sourceDocuments": [ { "id": "src_0e5cb45564a6cc69", "label": "FDA：KEFLEX（头孢氨苄）口服胶囊当前美国处方信息（NDA 050405；2026-08 修订）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/050405s111lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_pdf", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" }, { "id": "src_1755c454827a8b20", "label": "FDA Drugs@FDA：KEFLEX（cephalexin）NDA 050405 当前申请与标签记录", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=050405", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_database_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" } ], "applicationNumber": "FDA NDA 050405（KEFLEX / cephalexin oral capsules）", "approvalTimeline": [ { "date": "1971-01-01", "title": { "zh": "美国初始批准年份", "en": "Initial U.S. approval year" }, "detail": { "zh": "FDA 当前标签列出 Initial U.S. Approval: 1971。这里只记录年份，不推定具体首批包装、其他市场状态或当前供应。", "en": "The current FDA label states Initial U.S. Approval: 1971. This records the year only and does not infer the first pack, another market's status or current supply." }, "source": { "id": "src_0e5cb45564a6cc69", "label": "FDA：KEFLEX（头孢氨苄）口服胶囊当前美国处方信息（NDA 050405；2026-08 修订）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/050405s111lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_pdf", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" } }, { "date": "2015-10-30", "title": { "zh": "FDA 批准 SUPPL-106 标签更新", "en": "FDA approved the SUPPL-106 label update" }, "detail": { "zh": "FDA 批准信将 KEFLEX 250、500、750 mg 胶囊与 NDA 050405 相连。该节点用于核对申请历史，不替代当前标签。", "en": "The FDA approval letter links KEFLEX 250, 500 and 750 mg capsules to NDA 050405. This node checks application history and does not replace the current label." }, "source": { "id": "src_5554ee784d5f74ac", "label": "FDA：KEFLEX NDA 050405/S-106 补充批准信（2015）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050405Orig1s106ltr.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "regulatory_decision_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_pdf", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" } }, { "date": "2026-08-03", "title": { "zh": "FDA 发布 SUPPL-111 当前标签", "en": "FDA posted the current SUPPL-111 label" }, "detail": { "zh": "Drugs@FDA 当前申请页列出 2026-08-03 的 SUPPL-111 标签，处方信息修订日期为 2026-08。日期定位文件版本，不是任何人的开始用药日、疗程或库存结论。", "en": "The current Drugs@FDA application page lists the SUPPL-111 label on 3 Aug 2026, with prescribing information revised Aug 2026. The date identifies the file version, not anyone's start date, course or a stock conclusion." }, "source": { "id": "src_1755c454827a8b20", "label": "FDA Drugs@FDA：KEFLEX（cephalexin）NDA 050405 当前申请与标签记录", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=050405", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_database_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "已链接 FDA 当前申请记录、当前口服胶囊说明书和四个准确文字包装身份", "en": "Current FDA application record, oral-capsule label and four exact text package identities linked" }, "detail": { "zh": "本页记录 250、500、750 mg 胶囊的 NDC、瓶装数量、颜色与刻字。标签存在不等于任何地点有库存、可购买、适合个人或可以自行换规格。", "en": "The dossier records NDC, bottle count, colour and imprint for 250, 500 and 750 mg capsules. A label does not establish local stock, purchase availability, individual suitability or self-switching between strengths." } }, { "market": { "zh": "中国大陆、欧盟、日本及其他市场", "en": "Mainland China, EU, Japan and other markets" }, "status": { "zh": "待逐项建立现行市场记录", "en": "Current market record not established" }, "detail": { "zh": "不从美国品牌、NDA、通用名或胶囊外观推定当地商品名、批准、包装、供应、可售资格、原研/仿制关系或可替代性。", "en": "No local trade name, approval, packaging, supply, sale eligibility, originator/generic relationship or interchangeability is inferred from the U.S. brand, NDA, generic name or capsule appearance." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "包装写 500 mg，是否就表示一次吃一粒？", "en": "Does 500 mg on the pack mean one capsule per dose?" }, "answer": { "zh": "不是。500 mg 是每粒准确胶囊中的标签标示量；个人粒数、频率、疗程与是否适用必须来自准确处方，并结合感染类型、过敏史、肾功能、年龄和完整药单由专业人员确认。", "en": "No. 500 mg is the labelled amount in each exact capsule. Individual capsule count, frequency, course and suitability must come from the exact prescription and professional review of infection type, allergy history, kidney function, age and the complete medicine list." } }, { "question": { "zh": "胶囊太大，可以打开后倒一半或混进食物吗？", "en": "If the capsule is too large, can it be opened, halved or mixed into food?" }, "answer": { "zh": "不要自行这样做。当前页面核验的是完整口服胶囊，没有证据把目测分半或混食物写成等量、稳定和适合个人的替代方法。改变前请让药师或开方团队核对准确产品、可用剂型和处方。", "en": "Do not do this yourself. This page verifies an intact oral capsule and has no evidence that visual halving or mixing with food is an equal, stable and individually suitable alternative. Before changing it, ask a pharmacist or prescriber to check the exact product, available form and prescription." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "dosage-forms-are-part-of-medicine-identity", "how-to-read-a-drug-label" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/keflex/", "en": "https://origindrug.com/en/drugs/keflex/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "tessalon-benzonatate", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-31", "status": "published_traceable_archive" }, "names": { "brand": "TESSALON", "generic": "苯佐那酯", "aliases": [ "Tessalon", "benzonatate", "苯佐那酯", "苯佐那酯胶囊", "benzonatate capsules", "TESSALON", "NDA 011210", "64380-712-06", "64380-712-07", "64380-713-06", "64380-713-07" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "呼吸系统", "sourceArchiveMarket": "美国 FDA Orange Book 将 TESSALON 与 NDA 011210 相连：100 mg 产品 001 为 RLD 的 RX 行，200 mg 产品 003 为历史 RLD、当前 DISCN。当前用药安全内容采用 2026-06 DailyMed 通用药标签；历史品牌标签只用于解释 TESSALON 名称、机制与安全标签沿革，不能冒充当前品牌包装或实时供应。", "dosageFormClass": "苯佐那酯口服液体填充胶囊：100 mg 或 200 mg 均为每粒含量。胶囊必须整粒吞服，不得掰开、咀嚼、溶解、切开或压碎；网页不把 mg、瓶装粒数或历史品牌规格换算成个人用法。", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "1958（美国品牌初始批准年份）", "archiveSponsorText": "Pfizer（美国历史品牌 NDA 记录）；当前公开包装来自通用药标签" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [ "TESSALON benzonatate", "benzonatate capsules", "苯佐那酯", "苯佐那酯胶囊" ], "excludedProductCues": [ "dextromethorphan", "右美沙芬", "codeine cough syrup", "可待因止咳糖浆", "benzonatate compounded liquid", "苯佐那酯口服液" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-generic-benzonatate-100mg-6438071206", "marketCode": "US", "labelVersion": { "zh": "2026-06 当前美国通用药标签", "en": "Current U.S. generic label revised June 2026" }, "dosageForm": { "zh": "苯佐那酯 100 mg 口服液体填充胶囊", "en": "Benzonatate 100 mg oral liquid-filled capsule" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 64380-712-06", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_capsule", "primaryDisplay": { "zh": "每粒含苯佐那酯 100 mg；100 粒瓶装；mg 是每粒强度，不是个人粒数或频率", "en": "100 mg benzonatate per capsule; 100-capsule bottle; mg is strength per capsule, not an individual's capsule count or frequency" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "苯佐那酯", "en": "benzonatate" }, "value": 100, "unit": "mg", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒标签标示量；不得从该数字生成个人用法", "en": "labelled amount per capsule; must not generate individual use from this figure" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-31", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "current_generic_label_record", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_8862dd9659d90442", "label": "DailyMed（NLM）：苯佐那酯 100 mg、200 mg 口服胶囊当前美国通用药标签（2026-06 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=89f5d18e-5ef4-42a3-bc6f-abf4f308462b", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-31", "reviewedAt": "2026-08-31" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-generic-benzonatate-100mg-6438071207", "marketCode": "US", "labelVersion": { "zh": "2026-06 当前美国通用药标签", "en": "Current U.S. generic label revised June 2026" }, "dosageForm": { "zh": "苯佐那酯 100 mg 口服液体填充胶囊", "en": "Benzonatate 100 mg oral liquid-filled capsule" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 64380-712-07", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_capsule", "primaryDisplay": { "zh": "每粒含苯佐那酯 100 mg；500 粒瓶装；mg 是每粒强度，不是个人粒数或频率", "en": "100 mg benzonatate per capsule; 500-capsule bottle; mg is strength per capsule, not an individual's capsule count or frequency" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "苯佐那酯", "en": "benzonatate" }, "value": 100, "unit": "mg", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒标签标示量；不得从该数字生成个人用法", "en": "labelled amount per capsule; must not generate individual use from this figure" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 500, "countUnit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-31", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "current_generic_label_record", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 500, "unit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_8862dd9659d90442", "label": "DailyMed（NLM）：苯佐那酯 100 mg、200 mg 口服胶囊当前美国通用药标签（2026-06 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=89f5d18e-5ef4-42a3-bc6f-abf4f308462b", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-31", "reviewedAt": "2026-08-31" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-generic-benzonatate-200mg-6438071306", "marketCode": "US", "labelVersion": { "zh": "2026-06 当前美国通用药标签", "en": "Current U.S. generic label revised June 2026" }, "dosageForm": { "zh": "苯佐那酯 200 mg 口服液体填充胶囊", "en": "Benzonatate 200 mg oral liquid-filled capsule" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 64380-713-06", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_capsule", "primaryDisplay": { "zh": "每粒含苯佐那酯 200 mg；100 粒瓶装；mg 是每粒强度，不是个人粒数或频率", "en": "200 mg benzonatate per capsule; 100-capsule bottle; mg is strength per capsule, not an individual's capsule count or frequency" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "苯佐那酯", "en": "benzonatate" }, "value": 200, "unit": "mg", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒标签标示量；不得从该数字生成个人用法", "en": "labelled amount per capsule; must not generate individual use from this figure" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-31", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "current_generic_label_record", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_8862dd9659d90442", "label": "DailyMed（NLM）：苯佐那酯 100 mg、200 mg 口服胶囊当前美国通用药标签（2026-06 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=89f5d18e-5ef4-42a3-bc6f-abf4f308462b", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-31", "reviewedAt": "2026-08-31" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-generic-benzonatate-200mg-6438071307", "marketCode": "US", "labelVersion": { "zh": "2026-06 当前美国通用药标签", "en": "Current U.S. generic label revised June 2026" }, "dosageForm": { "zh": "苯佐那酯 200 mg 口服液体填充胶囊", "en": "Benzonatate 200 mg oral liquid-filled capsule" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 64380-713-07", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_capsule", "primaryDisplay": { "zh": "每粒含苯佐那酯 200 mg；500 粒瓶装；mg 是每粒强度，不是个人粒数或频率", "en": "200 mg benzonatate per capsule; 500-capsule bottle; mg is strength per capsule, not an individual's capsule count or frequency" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "苯佐那酯", "en": "benzonatate" }, "value": 200, "unit": "mg", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒标签标示量；不得从该数字生成个人用法", "en": "labelled amount per capsule; must not generate individual use from this figure" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 500, "countUnit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-31", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "current_generic_label_record", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 500, "unit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_8862dd9659d90442", "label": "DailyMed（NLM）：苯佐那酯 100 mg、200 mg 口服胶囊当前美国通用药标签（2026-06 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=89f5d18e-5ef4-42a3-bc6f-abf4f308462b", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-31", "reviewedAt": "2026-08-31" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-historic-tessalon-100mg-product-001", "marketCode": "US", "labelVersion": { "zh": "FDA Orange Book 当前数据集中的历史品牌记录", "en": "Historical brand record in the current FDA Orange Book dataset" }, "dosageForm": { "zh": "TESSALON 苯佐那酯 100 mg 口服胶囊", "en": "TESSALON benzonatate 100 mg oral capsule" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDA 011210 / Product 001", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_capsule", "primaryDisplay": { "zh": "历史品牌每粒 100 mg；Orange Book 当前为 RX 行", "en": "Historical brand 100 mg per capsule; currently an RX row in the Orange Book" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "苯佐那酯", "en": "benzonatate" }, "value": 100, "unit": "mg", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒历史品牌标示量；不证明当前品牌库存", "en": "amount per historical brand capsule; does not establish current brand stock" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-31", "currentLabelDisplayed": false, "ndcDirectoryListed": false, "marketAvailability": "orange_book_rx_historical_brand_record", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": null, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_10e511bf83430e3b", "label": "FDA Orange Book：TESSALON／benzonatate NDA 011210 品牌参比记录", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-historic-tessalon-200mg-product-003", "marketCode": "US", "labelVersion": { "zh": "FDA Orange Book 当前数据集中的历史品牌记录", "en": "Historical brand record in the current FDA Orange Book dataset" }, "dosageForm": { "zh": "TESSALON 苯佐那酯 200 mg 口服胶囊", "en": "TESSALON benzonatate 200 mg oral capsule" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDA 011210 / Product 003", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_capsule", "primaryDisplay": { "zh": "历史品牌每粒 200 mg；当前 DISCN", "en": "Historical brand 200 mg per capsule; currently DISCN" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "苯佐那酯", "en": "benzonatate" }, "value": 200, "unit": "mg", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒历史品牌标示量；不证明当前品牌库存", "en": "amount per historical brand capsule; does not establish current brand stock" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-31", "currentLabelDisplayed": false, "ndcDirectoryListed": false, "marketAvailability": "historical_discontinued_rld", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": null, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_10e511bf83430e3b", "label": "FDA Orange Book：TESSALON／benzonatate NDA 011210 品牌参比记录", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "status": "withheld_repackaged_or_non_exact_visual", "title": { "zh": "当前通用药标签有胶囊外观文字，但未把通用药外观冒充为 TESSALON 品牌包装", "en": "The current generic label has capsule appearance text, but generic appearance is not presented as a TESSALON brand pack" }, "summary": { "zh": "当前标签描述 100 mg 和 200 mg 为黄色椭圆软胶囊，但不同厂商、批次或市场外观可能不同。本站暂不展示未能与六个身份逐一对应的包装主图；颜色、形状或透明液体都不能单独确认真伪。", "en": "The current label describes yellow oval soft-gelatin capsules for 100 mg and 200 mg, but appearance can differ by manufacturer, batch or market. The site does not show a pack image that cannot be matched one-to-one to all six identities; colour, shape or visible liquid alone cannot establish authenticity." }, "source": { "id": "src_8862dd9659d90442", "label": "DailyMed（NLM）：苯佐那酯 100 mg、200 mg 口服胶囊当前美国通用药标签（2026-06 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=89f5d18e-5ef4-42a3-bc6f-abf4f308462b", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-31", "reviewedAt": "2026-08-31" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "苯佐那酯说明书放大阅读：整粒吞服、口咽麻木、儿童误服与过量急救", "en": "Benzonatate enlarged label: swallow whole, oral numbness, child ingestion and overdose emergency" }, "summary": { "zh": "100 mg、200 mg 是每粒强度，不是一次粒数。当前标签要求整粒吞服；任何儿童误服、疑似多服，或出现抽搐、昏迷、呼吸/心脏异常，都需要立即使用当地急救或毒物咨询渠道，并带上药盒。", "en": "100 mg and 200 mg are strengths per capsule, not a capsule count per dose. The current label requires swallowing the capsule whole. Any child ingestion, suspected extra ingestion, seizure, coma, breathing problem or cardiac problem requires immediate local emergency or poison-centre help with the pack." }, "checks": [ { "zh": "胶囊不得掰开、咀嚼、溶解、切开或压碎。内容物在口腔释放可造成暂时性口腔/咽喉麻木并引发呛噎；吞咽困难时不要自行改成液体、挤出或混食物，应让药师核对可用替代方案。", "en": "Do not break, chew, dissolve, cut or crush the capsule. Release in the mouth can cause temporary oral or throat anaesthesia and choking. For swallowing difficulty, do not self-convert it to a liquid, squeeze it out or mix it with food; ask a pharmacist to review an available alternative." }, { "zh": "若舌、口、咽喉或面部麻木/刺痛，不要继续进食或饮水直到麻木消退，以降低呛噎风险；症状加重、持续或伴呼吸困难，应立即就医。", "en": "If the tongue, mouth, throat or face becomes numb or tingles, avoid food and liquids until the numbness resolves to reduce choking risk. Worsening, persistent symptoms or breathing difficulty requires immediate medical care." }, { "zh": "儿童误服曾导致死亡，过量症状可在 15–20 分钟内出现，死亡可在一小时内发生。任何儿童误服或疑似过量都不要观察等待，应立即联系当地急救或毒物咨询。", "en": "Accidental child ingestion has caused death. Overdose features can begin within 15–20 minutes and death has been reported within one hour. Do not watch and wait after any child ingestion or suspected overdose; immediately contact local emergency or poison services." }, { "zh": "老年人、吞咽困难者、多药并用者，或既往对普鲁卡因、丁卡因等对氨基苯甲酸类局麻药有反应者，应带完整药单和准确药盒核对。网页不根据年龄、咳嗽或 mg 自动生成个人方案。", "en": "Older adults, people with dysphagia or several medicines, and those with prior reactions to para-aminobenzoic-acid local anaesthetics such as procaine or tetracaine should review the exact pack and full medicine list. The site does not generate an individual plan from age, cough or milligrams." } ], "source": { "id": "src_8862dd9659d90442", "label": "DailyMed（NLM）：苯佐那酯 100 mg、200 mg 口服胶囊当前美国通用药标签（2026-06 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=89f5d18e-5ef4-42a3-bc6f-abf4f308462b", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-31", "reviewedAt": "2026-08-31" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "苯佐那酯怎样减轻咳嗽：外周麻醉牵张感受器，不等于治疗咳嗽病因", "en": "How benzonatate reduces cough: peripheral anaesthesia of stretch receptors does not treat the cause" }, "summary": { "zh": "FDA 历史品牌标签描述其在呼吸道、肺和胸膜的牵张感受器处发挥外周麻醉作用，从而减弱咳嗽反射。机制只解释止咳路径，不能判断咳嗽是否由感染、哮喘、心脏问题、药物或其他原因引起。", "en": "The historical FDA brand label describes peripheral anaesthesia of stretch receptors in the respiratory passages, lungs and pleura, dampening the cough reflex. This mechanism explains the antitussive pathway only; it cannot determine whether a cough is due to infection, asthma, a cardiac problem, a medicine or another cause." }, "checks": [ { "zh": "这是处方止咳药档案，不是抗菌药，也不治疗所有咳嗽病因。呼吸困难、胸痛、咯血、发绀、意识改变或快速恶化应立即求助当地急救。", "en": "This is a prescription antitussive dossier, not an antibacterial, and it does not treat every cause of cough. Breathing difficulty, chest pain, coughing blood, cyanosis, altered awareness or rapid deterioration requires immediate local emergency help." }, { "zh": "与右美沙芬、可待因、抗组胺药或其他止咳感冒药用途相近，不表示可以按 mg 自行换算、叠加或轮换；先核对全部有效成分和完整药单。", "en": "A similar purpose to dextromethorphan, codeine, an antihistamine or another cough/cold product does not permit self-conversion, combination or rotation by milligrams. Check every active ingredient and the complete medicine list first." }, { "zh": "历史品牌标签描述的起效与持续时间是群体标签信息，不是网页用来判断某个人何时补服、加量或追加另一种止咳药的时钟。若咳嗽未缓解或反复，应核对病因和准确处方。", "en": "The onset and duration described in the historical brand label are population-level label information, not a clock for this site to decide when an individual should make up, increase or add another cough medicine. Persistent or recurrent cough requires review of the cause and exact prescription." } ], "source": { "id": "src_650d96939b67ceef", "label": "FDA：TESSALON NDA 011210/S-053 历史品牌标签（2011；不是当前标签）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/011210s053lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_historical_record", "documentKind": "historical_product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-31", "reviewedAt": "2026-08-31" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "TESSALON", "generic": "苯佐那酯", "dosageFormClass": "苯佐那酯口服液体填充胶囊：100 mg 或 200 mg 均为每粒含量。胶囊必须整粒吞服，不得掰开、咀嚼、溶解、切开或压碎；网页不把 mg、瓶装粒数或历史品牌规格换算成个人用法。" }, "labelSource": { "id": "src_8862dd9659d90442", "label": "DailyMed（NLM）：苯佐那酯 100 mg、200 mg 口服胶囊当前美国通用药标签（2026-06 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=89f5d18e-5ef4-42a3-bc6f-abf4f308462b", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-31", "reviewedAt": "2026-08-31" }, "productRoutes": [ { "source": { "id": "src_8862dd9659d90442", "label": "DailyMed（NLM）：苯佐那酯 100 mg、200 mg 口服胶囊当前美国通用药标签（2026-06 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=89f5d18e-5ef4-42a3-bc6f-abf4f308462b", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-31", "reviewedAt": "2026-08-31" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-31", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_10e511bf83430e3b", "label": "FDA Orange Book：TESSALON／benzonatate NDA 011210 品牌参比记录", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-08-29", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-31", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "TESSALON 是苯佐那酯的美国历史品牌档案。最重要的安全识别不是颜色，而是准确成分和完整胶囊：咀嚼或释放胶囊内容物可造成口咽麻木与呛噎；儿童误服或任何疑似过量都可能迅速危及生命，应立即联系当地急救或毒物咨询，不等待症状出现。", "history": "FDA 历史标签将 TESSALON 的美国初始批准年份列为 1958。200 mg 品牌规格于 1999-06-25 获批；2011 年 FDA 批准因儿童误服和过量风险而更新的安全标签。当前页面把历史品牌证据和 2026 年通用药标签明确分开。", "sourceDocuments": [ { "id": "src_8862dd9659d90442", "label": "DailyMed（NLM）：苯佐那酯 100 mg、200 mg 口服胶囊当前美国通用药标签（2026-06 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=89f5d18e-5ef4-42a3-bc6f-abf4f308462b", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-31", "reviewedAt": "2026-08-31" }, { "id": "src_650d96939b67ceef", "label": "FDA：TESSALON NDA 011210/S-053 历史品牌标签（2011；不是当前标签）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/011210s053lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_historical_record", "documentKind": "historical_product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-31", "reviewedAt": "2026-08-31" }, { "id": "src_758274046c04b250", "label": "FDA：TESSALON NDA 011210/S-053 儿童误服与过量安全标签补充批准信（2011）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/011210s053ltr.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_historical_record", "documentKind": "regulatory_decision_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-31", "reviewedAt": "2026-08-31" }, { "id": "src_10e511bf83430e3b", "label": "FDA Orange Book：TESSALON／benzonatate NDA 011210 品牌参比记录", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } ], "applicationNumber": "FDA NDA 011210（TESSALON / benzonatate oral capsules）", "approvalTimeline": [ { "date": "1958-01-01", "title": { "zh": "美国初始批准年份", "en": "Initial U.S. approval year" }, "detail": { "zh": "FDA 历史标签列 Initial U.S. Approval: 1958；这里只记录年份，不推定具体日期、包装或当前库存。", "en": "The historical FDA label states Initial U.S. Approval: 1958. This records the year only and does not infer an exact date, pack or current stock." }, "source": { "id": "src_650d96939b67ceef", "label": "FDA：TESSALON NDA 011210/S-053 历史品牌标签（2011；不是当前标签）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/011210s053lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_historical_record", "documentKind": "historical_product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-31", "reviewedAt": "2026-08-31" } }, { "date": "1999-06-25", "title": { "zh": "TESSALON 200 mg 品牌规格获批", "en": "TESSALON 200 mg brand strength approved" }, "detail": { "zh": "Orange Book 将产品 003、200 mg 与 NDA 011210 相连；当前为 DISCN，且公开数据说明并非因安全性或有效性撤回。", "en": "The Orange Book links Product 003, 200 mg, to NDA 011210. It is currently DISCN, with public data indicating no withdrawal for safety or effectiveness." }, "source": { "id": "src_10e511bf83430e3b", "label": "FDA Orange Book：TESSALON／benzonatate NDA 011210 品牌参比记录", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } }, { "date": "2011-02-10", "title": { "zh": "FDA 批准儿童误服与过量安全标签更新", "en": "FDA approved child-ingestion and overdose safety labelling" }, "detail": { "zh": "NDA 011210/S-053 补充批准信记录与儿童误服、过量和中毒风险有关的标签修订。", "en": "The NDA 011210/S-053 approval letter records labelling revisions addressing accidental child ingestion, overdose and poisoning risk." }, "source": { "id": "src_758274046c04b250", "label": "FDA：TESSALON NDA 011210/S-053 儿童误服与过量安全标签补充批准信（2011）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/011210s053ltr.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_historical_record", "documentKind": "regulatory_decision_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-31", "reviewedAt": "2026-08-31" } }, { "date": "2026-06-01", "title": { "zh": "当前通用药标签修订", "en": "Current generic label revision" }, "detail": { "zh": "DailyMed 当前页面列出 2026-06 修订的苯佐那酯胶囊标签；该文件用于当前安全阅读，不证明历史品牌当前有货。", "en": "The current DailyMed page lists a benzonatate capsule label revised June 2026. It supports current safety reading and does not establish current stock of the historical brand." }, "source": { "id": "src_8862dd9659d90442", "label": "DailyMed（NLM）：苯佐那酯 100 mg、200 mg 口服胶囊当前美国通用药标签（2026-06 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=89f5d18e-5ef4-42a3-bc6f-abf4f308462b", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-31", "reviewedAt": "2026-08-31" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "历史品牌参比记录与当前通用药标签并列", "en": "Historical brand reference record and current generic label shown separately" }, "detail": { "zh": "TESSALON 100 mg 的 Orange Book 行仍为 RX，200 mg 行为 DISCN；当前展示的四个 NDC 是通用药包装，不冒充品牌。", "en": "The TESSALON 100 mg Orange Book row remains RX, while the 200 mg row is DISCN. The four current NDCs shown are generic packs and are not presented as brand packs." } }, { "market": { "zh": "中国大陆、欧盟、日本及其他市场", "en": "Mainland China, EU, Japan and other markets" }, "status": { "zh": "待逐项建立现行市场记录", "en": "Current market record not established" }, "detail": { "zh": "不从美国 NDA、商品名或通用名推定当地批准、商品名、供应、处方资格、原研/仿制关系或可替代性。", "en": "No local approval, trade name, supply, prescription status, originator/generic relationship or interchangeability is inferred from the U.S. NDA, brand or generic name." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "100 mg 胶囊可以咬开或挤一半，变成 50 mg 吗？", "en": "Can a 100 mg capsule be bitten or half squeezed out to make 50 mg?" }, "answer": { "zh": "不可以。标签明确要求完整吞服，禁止掰开、咀嚼、溶解、切开或压碎；释放内容物可造成口咽麻木和呛噎。需要不同方案时应让药师或开方者核对准确替代产品。", "en": "No. The label requires swallowing whole and says not to break, chew, dissolve, cut or crush it. Released contents can cause oral/throat anaesthesia and choking. Ask a pharmacist or prescriber to review an exact alternative product if a different plan is needed." } }, { "question": { "zh": "孩子可能误吞了一粒，但现在没有症状，可以先观察吗？", "en": "A child may have swallowed one capsule but has no symptoms. Can we watch first?" }, "answer": { "zh": "不要等待症状。儿童误服可能迅速危及生命，应立即联系当地急救或毒物咨询，并带上准确药盒；网页不能远程排除风险。", "en": "Do not wait for symptoms. Accidental child ingestion can become life-threatening rapidly. Immediately contact local emergency or poison services and take the exact pack; a webpage cannot rule out risk remotely." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "dosage-forms-are-part-of-medicine-identity", "how-to-read-a-drug-label", "dose-unit-literacy" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/tessalon-benzonatate/", "en": "https://origindrug.com/en/drugs/tessalon-benzonatate/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "suprax", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-31", "status": "published_traceable_archive" }, "names": { "brand": "SUPRAX", "generic": "头孢克肟", "aliases": [ "Suprax", "cefixime", "cefixime trihydrate", "头孢克肟", "头孢克肟胶囊", "头孢克肟混悬液", "NDA 202091", "NDA 203195" ], "marketBrandNames": [ { "name": "SUPRAX", "market": { "zh": "美国", "en": "United States" }, "evidenceStatus": "current_regulatory_record", "note": { "zh": "FDA Orange Book 当前列出 NDA 203195 的 400 mg 胶囊及 NDA 202091 的 500 mg/5 mL 混悬液；DailyMed 标签同时含其他 ANDA 剂型，页面只把准确 NDA 产品作为本档案核心。", "en": "The current FDA Orange Book lists the 400 mg capsule under NDA 203195 and 500 mg/5 mL suspension under NDA 202091. The DailyMed label also contains other ANDA forms; this dossier keeps the exact NDA products at its core." }, "source": { "id": "src_10e511bf83430e3b", "label": "FDA：Orange Book 当前数据文件与产品状态说明", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } }, { "name": "SUPRAX", "market": { "zh": "加拿大", "en": "Canada" }, "evidenceStatus": "current_regulatory_record", "note": { "zh": "Health Canada DPD 分别列出 Marketed 的 100 mg/5 mL、DIN 00868965 与 400 mg、DIN 00868981；加拿大产品不得用美国 NDC、浓度或包装替代。", "en": "Health Canada's DPD separately lists marketed 100 mg/5 mL DIN 00868965 and 400 mg DIN 00868981 products. U.S. NDCs, concentrations and packs must not substitute for the Canadian identities." }, "source": { "id": "src_f569b57eee87a182", "label": "Health Canada：药品产品数据库（DPD）当前访问页；在库内核对 SUPRAX 100 mg/5 mL／DIN 00868965", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_lookup_entry", "documentKind": "regulatory_lookup", "market": "CA", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-09-13", "reviewedAt": "2026-09-13" } } ], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "感染", "sourceArchiveMarket": "美国 FDA 当前 Orange Book：SUPRAX 400 mg 口服胶囊 NDA 203195 与 500 mg/5 mL 口服混悬液 NDA 202091 为 RX、RLD 与 RS；加拿大 DPD 另有 Marketed 的 100 mg/5 mL（DIN 00868965）和 400 mg（DIN 00868981）SUPRAX。市场与剂型不得合并。", "dosageFormClass": "美国当前两个 NDA 产品：400 mg/粒口服胶囊；按标签复溶后 500 mg/5 mL 口服混悬液。DailyMed 同一标签还列出其他 ANDA 片剂、咀嚼片和混悬液浓度，它们不并入这四个 NDA 包装身份。", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "1989", "archiveSponsorText": "Lupin Limited（FDA Orange Book 当前 NDA 202091 / 203195 申请方）；加拿大记录另列 ODAN Laboratories Ltd." }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [ "SUPRAX", "Suprax cefixime", "头孢克肟", "头孢克肟胶囊", "头孢克肟 500 mg/5 mL" ], "excludedProductCues": [ "cefixime 100 mg/5 mL", "cefixime 200 mg/5 mL", "cefixime 400 mg tablet", "cefixime chewable tablet", "头孢克肟片", "头孢克肟咀嚼片" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-suprax-cefixime-400mg-50-capsule-bottle-ndc-2743720808", "marketCode": "US", "labelVersion": { "zh": "DailyMed 美国公开处方标签（页面 2026-08-31 复核）", "en": "U.S. DailyMed public prescribing label (page reviewed 31 Aug 2026)" }, "dosageForm": { "zh": "SUPRAX 头孢克肟 400 mg 口服胶囊", "en": "SUPRAX cefixime 400 mg oral capsule" }, "route": { "zh": "口服（准确胶囊产品身份字段）", "en": "oral (exact capsule-product identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 27437-208-08", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_capsule", "primaryDisplay": { "zh": "每粒含头孢克肟 400 mg；50 粒瓶装", "en": "Cefixime 400 mg per capsule; 50-capsule bottle" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "头孢克肟（以三水合物提供）", "en": "cefixime (supplied as the trihydrate)" }, "value": 400, "unit": "mg", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒标签标示量；不是个人粒数、频率、疗程或补服指令", "en": "labelled amount per capsule; not an individual's capsule count, frequency, course or missed-use instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 50, "countUnit": { "zh": "粒/包装", "en": "capsules per pack" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-31", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 50, "unit": { "zh": "粒/包装", "en": "capsules per pack" } }, "physicalClues": { "color": { "zh": "粉红色不透明帽与粉红色不透明体", "en": "pink opaque cap and pink opaque body" }, "shape": { "zh": "00EL 号胶囊；无刻痕", "en": "size 00EL capsule; unscored" }, "imprint": "LU / U43", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_3562d316eeff699a", "label": "DailyMed（NLM）：SUPRAX／cefixime 美国公开处方标签", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=655a59ba-08e9-51d4-e053-2991aa0aef34", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-31", "reviewedAt": "2026-08-31" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-suprax-cefixime-400mg-10-unit-dose-capsule-blister-ndc-2743720811", "marketCode": "US", "labelVersion": { "zh": "DailyMed 美国公开处方标签（页面 2026-08-31 复核）", "en": "U.S. DailyMed public prescribing label (page reviewed 31 Aug 2026)" }, "dosageForm": { "zh": "SUPRAX 头孢克肟 400 mg 口服胶囊", "en": "SUPRAX cefixime 400 mg oral capsule" }, "route": { "zh": "口服（准确胶囊产品身份字段）", "en": "oral (exact capsule-product identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 27437-208-11", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_capsule", "primaryDisplay": { "zh": "每粒含头孢克肟 400 mg；10 粒单位剂量泡罩包装", "en": "Cefixime 400 mg per capsule; 10-capsule unit-dose blister pack" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "头孢克肟（以三水合物提供）", "en": "cefixime (supplied as the trihydrate)" }, "value": 400, "unit": "mg", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒标签标示量；不是个人粒数、频率、疗程或补服指令", "en": "labelled amount per capsule; not an individual's capsule count, frequency, course or missed-use instruction" } } ], "concentration": null, "container": { "typeCode": "unit_dose_blister", "typeLabel": { "zh": "单位剂量泡罩包装", "en": "unit-dose blister pack" }, "fill": null, "countPerPackage": 10, "countUnit": { "zh": "粒/包装", "en": "capsules per pack" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-31", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 10, "unit": { "zh": "粒/包装", "en": "capsules per pack" } }, "physicalClues": { "color": { "zh": "粉红色不透明帽与粉红色不透明体", "en": "pink opaque cap and pink opaque body" }, "shape": { "zh": "00EL 号胶囊；无刻痕", "en": "size 00EL capsule; unscored" }, "imprint": "LU / U43", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_3562d316eeff699a", "label": "DailyMed（NLM）：SUPRAX／cefixime 美国公开处方标签", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=655a59ba-08e9-51d4-e053-2991aa0aef34", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-31", "reviewedAt": "2026-08-31" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-suprax-cefixime-500mg-per-5ml-10ml-bottle-ndc-2743720702", "marketCode": "US", "labelVersion": { "zh": "DailyMed 美国公开处方标签（页面 2026-08-31 复核）", "en": "U.S. DailyMed public prescribing label (page reviewed 31 Aug 2026)" }, "dosageForm": { "zh": "SUPRAX 头孢克肟 500 mg/5 mL 口服混悬液用粉末", "en": "SUPRAX cefixime 500 mg/5 mL powder for oral suspension" }, "route": { "zh": "口服；复溶后混悬液（准确浓度产品身份字段）", "en": "oral; suspension after reconstitution (exact concentration identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 27437-207-02", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_5_mL_after_reconstitution", "primaryDisplay": { "zh": "按标签复溶后每 5 mL 含头孢克肟 500 mg；10 mL 瓶装", "en": "Cefixime 500 mg per 5 mL after reconstitution as labelled; 10 mL bottle" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "头孢克肟（以三水合物提供）", "en": "cefixime (supplied as the trihydrate)" }, "value": 500, "unit": "mg", "basisCode": "per_5_mL_after_reconstitution", "basisLabel": { "zh": "按标签复溶后每 5 mL 的浓度；不是个人毫升数、频率、疗程或调配指令", "en": "concentration per 5 mL after labelled reconstitution; not an individual's millilitres, frequency, course or mixing instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "待复溶粉末瓶", "en": "powder-for-reconstitution bottle" }, "fill": null, "countPerPackage": null, "countUnit": null }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-31", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "unit": { "zh": "mL/瓶（复溶后标示包装体积）", "en": "mL per bottle (labelled reconstituted pack volume)" } }, "physicalClues": { "color": { "zh": "类白色至乳白色粉末；复溶后为类白色至淡黄色混悬液", "en": "off-white to cream powder; off-white to pale-yellow suspension after reconstitution" }, "shape": { "zh": "草莓味口服混悬液用粉末", "en": "strawberry-flavoured powder for oral suspension" }, "imprint": null, "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_3562d316eeff699a", "label": "DailyMed（NLM）：SUPRAX／cefixime 美国公开处方标签", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=655a59ba-08e9-51d4-e053-2991aa0aef34", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-31", "reviewedAt": "2026-08-31" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-suprax-cefixime-500mg-per-5ml-20ml-bottle-ndc-2743720703", "marketCode": "US", "labelVersion": { "zh": "DailyMed 美国公开处方标签（页面 2026-08-31 复核）", "en": "U.S. DailyMed public prescribing label (page reviewed 31 Aug 2026)" }, "dosageForm": { "zh": "SUPRAX 头孢克肟 500 mg/5 mL 口服混悬液用粉末", "en": "SUPRAX cefixime 500 mg/5 mL powder for oral suspension" }, "route": { "zh": "口服；复溶后混悬液（准确浓度产品身份字段）", "en": "oral; suspension after reconstitution (exact concentration identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 27437-207-03", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_5_mL_after_reconstitution", "primaryDisplay": { "zh": "按标签复溶后每 5 mL 含头孢克肟 500 mg；20 mL 瓶装", "en": "Cefixime 500 mg per 5 mL after reconstitution as labelled; 20 mL bottle" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "头孢克肟（以三水合物提供）", "en": "cefixime (supplied as the trihydrate)" }, "value": 500, "unit": "mg", "basisCode": "per_5_mL_after_reconstitution", "basisLabel": { "zh": "按标签复溶后每 5 mL 的浓度；不是个人毫升数、频率、疗程或调配指令", "en": "concentration per 5 mL after labelled reconstitution; not an individual's millilitres, frequency, course or mixing instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "待复溶粉末瓶", "en": "powder-for-reconstitution bottle" }, "fill": null, "countPerPackage": null, "countUnit": null }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-31", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "unit": { "zh": "mL/瓶（复溶后标示包装体积）", "en": "mL per bottle (labelled reconstituted pack volume)" } }, "physicalClues": { "color": { "zh": "类白色至乳白色粉末；复溶后为类白色至淡黄色混悬液", "en": "off-white to cream powder; off-white to pale-yellow suspension after reconstitution" }, "shape": { "zh": "草莓味口服混悬液用粉末", "en": "strawberry-flavoured powder for oral suspension" }, "imprint": null, "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_3562d316eeff699a", "label": "DailyMed（NLM）：SUPRAX／cefixime 美国公开处方标签", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=655a59ba-08e9-51d4-e053-2991aa0aef34", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-31", "reviewedAt": "2026-08-31" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": null, "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=70934-079-01+-+Rev+B+09-19.jpg&setid=655a59ba-08e9-51d4-e053-2991aa0aef34&type=img", "alt": "SUPRAX cefixime 400 mg capsule official DailyMed unit-dose label, NDC 70934-079-01", "archiveMarket": "美国", "labelVersion": "Rev. B 09/19", "presentation": "SUPRAX／cefixime 400 mg 胶囊单位剂量标签；再包装 NDC 70934-079-01，标注原生产 NDC 27437-208-08", "notice": "这是 DailyMed 公开标签中的单位剂量再包装标签图，可核对 SUPRAX、cefixime、400 mg、每粒、NDC 70934-079-01 与原生产 NDC 27437-208-08。它不是 50 粒原瓶正面图，不用于鉴定真伪，也不证明当前库存、其他包装、其他市场身份或个人适用性。", "source": { "id": "src_3562d316eeff699a", "label": "DailyMed（NLM）：SUPRAX／cefixime 美国公开处方标签", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=655a59ba-08e9-51d4-e053-2991aa0aef34", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-31", "reviewedAt": "2026-08-31" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "SUPRAX 说明书放大阅读：先区分“每粒 400 mg”和“每 5 mL 500 mg”", "en": "SUPRAX label reading: first separate 400 mg per capsule from 500 mg per 5 mL" }, "summary": { "zh": "胶囊标示的是每粒含量，混悬液标示的是按标签复溶后的浓度。它们都属于产品身份，不是个人一次用量。先核对准确剂型、浓度、NDC、处方和量具，再由医生或药师确认个人方案。", "en": "The capsule states an amount per capsule; the suspension states a concentration after labelled reconstitution. Both are product-identity fields, not an individual's amount per use. Check the exact form, concentration, NDC, prescription and measuring device before a clinician or pharmacist confirms an individual plan." }, "checks": [ { "zh": "400 mg 是每粒胶囊中的标签标示量；500 mg/5 mL 是混悬液复溶后的浓度。不要把“总 mg 看起来一样”理解为胶囊和液体能自行换算、互换、拆分或补服。", "en": "400 mg is the labelled amount in each capsule; 500 mg/5 mL is the concentration after suspension reconstitution. A similar total milligram number does not make capsule and liquid self-convertible, interchangeable, divisible or suitable for making up a missed use." }, { "zh": "同一 DailyMed 标签还列出 100 mg/5 mL、200 mg/5 mL、500 mg/5 mL 三种混悬液浓度。任何以 mL 表示的医嘱都必须同时写清准确浓度；网页不会只凭“几毫升”或年龄体重补出个人处方。", "en": "The same DailyMed label lists 100 mg/5 mL, 200 mg/5 mL and 500 mg/5 mL suspension concentrations. Any order expressed in mL must also identify the exact concentration; the site will not derive a personal prescription from millilitres, age or weight." }, { "zh": "对头孢克肟、其他头孢菌素或青霉素有过敏史，应在使用前告诉开方团队。呼吸困难、面部或咽喉肿胀、晕厥、广泛皮疹或其他严重过敏表现需要立即使用当地急救服务。", "en": "Tell the prescriber about previous reactions to cefixime, other cephalosporins or penicillins. Breathing difficulty, facial or throat swelling, fainting, widespread rash or another severe allergic feature requires immediate local emergency care." }, { "zh": "严重、持续或带血腹泻，明显腹痛、发热、脱水或虚弱需要尽快医疗评估；标签说明相关问题可能在抗菌药结束后出现。不要自行用止泻药掩盖严重症状。", "en": "Severe, persistent or bloody diarrhoea, marked abdominal pain, fever, dehydration or weakness needs prompt medical assessment. The label explains that the problem can appear after antibacterial treatment has ended. Do not self-use an antidiarrhoeal medicine to mask severe symptoms." }, { "zh": "老年人或肾功能受损者需要由专业人员核对肾功能和处方。服用卡马西平、华法林或其他抗凝药的人，应把完整药单交给医生或药师复核；不要从网页自行减量、隔天用或换浓度。", "en": "Older adults or people with impaired kidney function need professional review of kidney function and the prescription. People taking carbamazepine, warfarin or another anticoagulant should give the complete medicine list to a clinician or pharmacist; do not self-reduce, alternate days or change concentration from the website." }, { "zh": "混悬液必须按准确瓶装说明复溶，并使用适合的量具；家用汤匙、目测液面或把剩余药液倒进另一瓶都不能保证准确。配制、保存、摇匀和丢弃时间请以手中产品现行说明书及药师指示为准。", "en": "The suspension must be reconstituted according to the exact bottle instructions and measured with a suitable device. A household spoon, visual liquid level or transfer into another bottle cannot ensure accuracy. Follow the current label for the product in hand and pharmacist instructions for mixing, storage, shaking and discard timing." } ], "source": { "id": "src_3562d316eeff699a", "label": "DailyMed（NLM）：SUPRAX／cefixime 美国公开处方标签", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=655a59ba-08e9-51d4-e053-2991aa0aef34", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-31", "reviewedAt": "2026-08-31" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "头孢克肟怎样起作用：抑制细菌细胞壁合成，不等于对所有感染都有效", "en": "How cefixime works: inhibiting bacterial cell-wall synthesis does not mean it treats every infection" }, "summary": { "zh": "FDA 审评资料将头孢克肟描述为口服头孢菌素抗菌药，通过抑制细菌细胞壁合成发挥抗菌作用。机制帮助理解药物类别，但不能仅凭发热、咳嗽、咽痛、尿路或其他症状判断是否为细菌感染、是否敏感或该用多久。", "en": "FDA review material describes cefixime as an oral cephalosporin antibacterial that acts by inhibiting bacterial cell-wall synthesis. The mechanism helps explain the class but cannot establish from fever, cough, sore throat, urinary or other symptoms whether an infection is bacterial, susceptible or how long treatment should last." }, "checks": [ { "zh": "抗菌药不治疗普通病毒性感冒。不要使用剩药、借用他人药品、因症状相似自行开始，或在感觉好转后自行缩短处方疗程。", "en": "Antibacterials do not treat an ordinary viral cold. Do not use leftovers, borrow another person's medicine, self-start because symptoms seem similar or shorten a prescribed course because you feel better." }, { "zh": "SUPRAX、KEFLEX、CEFTIN、阿莫西林、阿莫西林/克拉维酸、阿奇霉素和左氧氟沙星都可能出现在感染相关处方中，但不表示可以自行叠加、轮换或替代。", "en": "SUPRAX, KEFLEX, CEFTIN, amoxicillin, amoxicillin/clavulanate, azithromycin and levofloxacin may all appear in infection-related prescribing, but that does not make them self-combinable, alternatable or substitutable." }, { "zh": "感染部位、培养或药敏结果、过敏史、肾功能、年龄和完整药单都会影响专业判断；网页只帮助读懂准确说明书和提出问题，不替个人选择抗菌药。", "en": "Infection site, culture or susceptibility results, allergy history, kidney function, age and the complete medicine list can affect professional judgement. The site helps read the exact label and frame questions; it does not choose an antibacterial for an individual." } ], "source": { "id": "src_032efcd9844a80ad", "label": "FDA：SUPRAX／cefixime 500 mg/5 mL NDA 202091 临床审评（机制与监管背景）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/202091Orig1s000MedR.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "regulatory_review_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_pdf", "accessVerifiedAt": "2026-08-31", "reviewedAt": "2026-08-31" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "SUPRAX", "generic": "头孢克肟", "dosageFormClass": "美国当前两个 NDA 产品：400 mg/粒口服胶囊；按标签复溶后 500 mg/5 mL 口服混悬液。DailyMed 同一标签还列出其他 ANDA 片剂、咀嚼片和混悬液浓度，它们不并入这四个 NDA 包装身份。" }, "labelSource": { "id": "src_3562d316eeff699a", "label": "DailyMed（NLM）：SUPRAX／cefixime 美国公开处方标签", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=655a59ba-08e9-51d4-e053-2991aa0aef34", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-31", "reviewedAt": "2026-08-31" }, "productRoutes": [ { "source": { "id": "src_3562d316eeff699a", "label": "DailyMed（NLM）：SUPRAX／cefixime 美国公开处方标签", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=655a59ba-08e9-51d4-e053-2991aa0aef34", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-31", "reviewedAt": "2026-08-31" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-31", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_10e511bf83430e3b", "label": "FDA：Orange Book 当前数据文件与产品状态说明", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-08-29", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-31", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "SUPRAX 是头孢克肟品牌档案。美国当前 NDA 产品包括 400 mg 口服胶囊和复溶后 500 mg/5 mL 口服混悬液；两者的“每粒 mg”和“每 5 mL 浓度”不是同一种单位。本页分开呈现准确包装、说明书、作用机理、过敏和严重腹泻警示、肾功能与联用药核对，不把包装数字换算成个人该吃几粒或几毫升。", "history": "美国旧 SUPRAX 200/400 mg 片剂 NDA 050621 和 100 mg/5 mL 混悬液 NDA 050622 于 1989-04-28 获批，当前 Orange Book 标为 DISCN，并注明 FDA 判定并非因安全性或有效性撤回。当前 RX 产品为 2012 年获批的 400 mg 胶囊 NDA 203195 和 2013 年获批的 500 mg/5 mL 混悬液 NDA 202091。加拿大的同名产品由当地 DPD 单独记录。", "sourceDocuments": [ { "id": "src_3562d316eeff699a", "label": "DailyMed（NLM）：SUPRAX／cefixime 美国公开处方标签", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=655a59ba-08e9-51d4-e053-2991aa0aef34", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-31", "reviewedAt": "2026-08-31" }, { "id": "src_10e511bf83430e3b", "label": "FDA：Orange Book 当前数据文件与产品状态说明", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, { "id": "src_f569b57eee87a182", "label": "Health Canada：药品产品数据库（DPD）当前访问页；在库内核对 SUPRAX 100 mg/5 mL／DIN 00868965", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_lookup_entry", "documentKind": "regulatory_lookup", "market": "CA", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-09-13", "reviewedAt": "2026-09-13" }, { "id": "src_f569b57eee87a182", "label": "Health Canada：药品产品数据库（DPD）当前访问页；在库内核对 SUPRAX 400 mg／DIN 00868981", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_lookup_entry", "documentKind": "regulatory_lookup", "market": "CA", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-09-13", "reviewedAt": "2026-09-13" } ], "applicationNumber": "FDA NDA 202091（500 mg/5 mL suspension）／NDA 203195（400 mg capsule）", "approvalTimeline": [ { "date": "1989-04-28", "title": { "zh": "旧 SUPRAX 片剂与混悬液获 FDA 批准", "en": "Earlier SUPRAX tablet and suspension NDAs approved" }, "detail": { "zh": "NDA 050621 的 200/400 mg 片剂和 NDA 050622 的 100 mg/5 mL 混悬液后来停止上市；Orange Book 注明 FDA 判定并非因安全性或有效性撤回。历史状态不代表当前供应。", "en": "The 200/400 mg tablets under NDA 050621 and 100 mg/5 mL suspension under NDA 050622 were later discontinued. Orange Book notes FDA determined they were not withdrawn for safety or effectiveness. Historical status does not establish current supply." }, "source": { "id": "src_10e511bf83430e3b", "label": "FDA：Orange Book 当前数据文件与产品状态说明", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } }, { "date": "2012-06-01", "title": { "zh": "SUPRAX 400 mg 胶囊 NDA 203195 获批", "en": "SUPRAX 400 mg capsule NDA 203195 approved" }, "detail": { "zh": "FDA 批准信把 SUPRAX 400 mg 胶囊与 NDA 203195 相连。当前 Orange Book 将其列为 RX、参比制剂和参比标准。", "en": "The FDA approval letter links SUPRAX 400 mg capsules to NDA 203195. The current Orange Book lists it as prescription, reference listed drug and reference standard." }, "source": { "id": "src_473f66126918d09e", "label": "FDA：SUPRAX 400 mg 胶囊 NDA 203195 批准信", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/203195s000ltr.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "regulatory_decision_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_pdf", "accessVerifiedAt": "2026-08-31", "reviewedAt": "2026-08-31" } }, { "date": "2013-02-20", "title": { "zh": "SUPRAX 500 mg/5 mL 混悬液 NDA 202091 获批", "en": "SUPRAX 500 mg/5 mL suspension NDA 202091 approved" }, "detail": { "zh": "FDA 审评资料将 500 mg/5 mL 口服混悬液与 NDA 202091 相连；当前 Orange Book 将其列为 RX、参比制剂和参比标准。", "en": "FDA review material links the 500 mg/5 mL oral suspension to NDA 202091. The current Orange Book lists it as prescription, reference listed drug and reference standard." }, "source": { "id": "src_032efcd9844a80ad", "label": "FDA：SUPRAX 500 mg/5 mL 混悬液 NDA 202091 临床审评", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/202091Orig1s000MedR.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "regulatory_review_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_pdf", "accessVerifiedAt": "2026-08-31", "reviewedAt": "2026-08-31" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "两个当前 RX NDA 产品已核验", "en": "Two current prescription NDA products verified" }, "detail": { "zh": "当前 Orange Book 列出 400 mg 胶囊 NDA 203195 与 500 mg/5 mL 混悬液 NDA 202091。本页只记录准确监管与包装身份，不证明任何地点库存、可购买或个人适用。", "en": "The current Orange Book lists the 400 mg capsule under NDA 203195 and 500 mg/5 mL suspension under NDA 202091. The dossier records exact regulatory and package identity and does not establish local stock, purchase availability or individual suitability." } }, { "market": { "zh": "加拿大", "en": "Canada" }, "status": { "zh": "两个 Marketed SUPRAX 产品记录已核验", "en": "Two marketed SUPRAX product records verified" }, "detail": { "zh": "Health Canada DPD 分别列出 DIN 00868965 的 100 mg/5 mL 和 DIN 00868981 的 400 mg SUPRAX；不从加拿大记录推定美国 NDC、剂型细节或其他市场身份。", "en": "Health Canada's DPD separately lists 100 mg/5 mL DIN 00868965 and 400 mg DIN 00868981 SUPRAX. Canadian records do not establish U.S. NDCs, form details or another market's identity." } }, { "market": { "zh": "中国大陆、欧盟、日本及其他市场", "en": "Mainland China, EU, Japan and other markets" }, "status": { "zh": "待逐项建立现行市场记录", "en": "Current market record not established" }, "detail": { "zh": "不从 SUPRAX 商品名、cefixime 通用名或包装颜色推定当地批准、商品名、剂型、供应、可售资格、原研/仿制关系或可替代性。", "en": "No local approval, trade name, form, supply, sale eligibility, originator/generic relationship or interchangeability is inferred from the SUPRAX name, cefixime generic name or package colour." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "400 mg 胶囊与 500 mg/5 mL 混悬液是不是可以直接换算？", "en": "Can the 400 mg capsule and 500 mg/5 mL suspension be directly converted?" }, "answer": { "zh": "不能自行换算或替换。一个是每粒含量，一个是复溶后浓度；剂型、吸收、准确处方、量具、肾功能和感染情况都需要专业人员核对。网页不会把浓度算成个人毫升数。", "en": "Do not self-convert or substitute them. One is an amount per capsule and the other a concentration after reconstitution. Form, absorption, the exact prescription, measuring device, kidney function and infection all need professional review. The site will not turn concentration into an individual's millilitres." } }, { "question": { "zh": "胶囊可以打开倒一半，或者混悬液少摇几下吗？", "en": "Can the capsule be opened and halved, or the suspension shaken less?" }, "answer": { "zh": "不要自行这样做。页面核验的是完整胶囊和按准确标签复溶、摇匀、量取的混悬液。目测分半或未充分混匀都不能保证得到准确产品单位；改变前请让药师核对手中包装和处方。", "en": "Do not do this yourself. The dossier verifies an intact capsule and suspension reconstituted, shaken and measured according to the exact label. Visual halving or inadequate mixing cannot ensure an accurate product unit; ask a pharmacist to check the pack and prescription before changing anything." } }, { "question": { "zh": "以前感染剩下的 SUPRAX 能留到下次吃吗？", "en": "Can leftover SUPRAX from an earlier infection be saved for next time?" }, "answer": { "zh": "不要自行留用或复用。相似症状不等于同一病原、感染部位或敏感性；剩余药品的保存、复溶后期限、浓度和完整疗程也可能不适用。请让医生或药师重新评估。", "en": "Do not self-save or reuse it. Similar symptoms do not establish the same organism, infection site or susceptibility, and storage, post-reconstitution life, concentration and a complete course may no longer fit. Ask a clinician or pharmacist to reassess." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "dosage-forms-are-part-of-medicine-identity", "how-to-read-a-drug-label" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/suprax/", "en": "https://origindrug.com/en/drugs/suprax/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "tapazole", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-31", "status": "published_traceable_archive" }, "names": { "brand": "TAPAZOLE", "generic": "甲巯咪唑（甲硫咪唑）", "aliases": [ "Tapazole", "methimazole", "thiamazole", "甲巯咪唑", "甲硫咪唑", "他巴唑", "甲巯咪唑片", "NDA 007517", "DIN 00015741", "DIN 02296039" ], "marketBrandNames": [ { "name": "TAPAZOLE", "market": { "zh": "美国", "en": "United States" }, "evidenceStatus": "historical_public_record", "note": { "zh": "NDA 007517 的 5 mg 与 10 mg 历史 RLD 当前列为 DISCN；不是当前品牌供应记录。", "en": "Historical 5 mg and 10 mg RLD products under NDA 007517 are currently listed as discontinued; this is not a current brand-supply record." }, "source": { "id": "src_10e511bf83430e3b", "label": "FDA Orange Book：TAPAZOLE／methimazole NDA 007517 的 5 mg 与 10 mg 历史 RLD 记录", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } }, { "name": "TAPAZOLE", "market": { "zh": "加拿大", "en": "Canada" }, "evidenceStatus": "historical_public_record", "note": { "zh": "5 mg 与 10 mg 产品均于 2026-07-16 列为 Cancelled Post Market；2025-12-19 产品专论仍作为有日期说明书档案阅读。", "en": "The 5 mg and 10 mg products were both listed Cancelled Post Market on 16 Jul 2026; the 19 Dec 2025 product monograph remains a dated label archive." }, "source": { "id": "src_f569b57eee87a182", "label": "Health Canada：药品产品数据库（DPD）当前访问页；在库内核对 TAPAZOLE 5 mg／DIN 00015741", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_lookup_entry", "documentKind": "regulatory_lookup", "market": "CA", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-09-13", "reviewedAt": "2026-09-13" } } ], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "代谢", "sourceArchiveMarket": "美国 FDA Orange Book：TAPAZOLE 5 mg 与 10 mg 口服片 NDA 007517 为历史 RLD、当前 DISCN，且 FDA 判定并非因安全性或有效性撤回；加拿大 DPD：TAPAZOLE 5 mg（DIN 00015741）与 10 mg（DIN 02296039）均于 2026-07-16 列为 Cancelled Post Market。加拿大同成分通用药另有 Marketed 记录，但不等于品牌供应或自动可替代。", "dosageFormClass": "历史品牌口服片：每片甲巯咪唑 5 mg 或 10 mg；5 mg 与 10 mg 是每片含量，不是网页给出的个人片数；美国、加拿大及当前通用药记录必须分开核对。", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "1951（加拿大最早市场日期）；美国 NDA 007517 批准早于 1982", "archiveSponsorText": "美国历史 NDA：King Pharmaceuticals Inc.；加拿大历史品牌：Knight Therapeutics Inc." }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [ "TAPAZOLE", "Tapazole methimazole", "甲巯咪唑", "甲硫咪唑", "他巴唑" ], "excludedProductCues": [ "propylthiouracil", "PTU", "丙硫氧嘧啶", "carbimazole", "卡比马唑", "radioactive iodine", "左甲状腺素" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-tapazole-methimazole-5mg-tablet-nda-007517-product-002-historical", "marketCode": "US", "labelVersion": { "zh": "FDA Orange Book 当前数据中的历史产品身份（2026-08-29 核验）", "en": "Historical product identity in the current FDA Orange Book dataset (checked 29 Aug 2026)" }, "dosageForm": { "zh": "TAPAZOLE 甲巯咪唑 5 mg 口服片（美国历史 RLD）", "en": "TAPAZOLE methimazole 5 mg oral tablet (historical U.S. RLD)" }, "route": { "zh": "口服（历史监管产品身份字段）", "en": "oral (historical regulatory product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDA 007517 / Product 002", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片甲巯咪唑 5 mg；美国历史 RLD，当前列为停止销售", "en": "Methimazole 5 mg per tablet; historical U.S. RLD currently listed as discontinued" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "甲巯咪唑（methimazole）", "en": "methimazole" }, "value": 5, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片历史监管标示量；不是个人片数、频率或调药指令", "en": "historical regulatory amount per tablet; not an individual's tablet count, frequency or adjustment instruction" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-31", "currentLabelDisplayed": false, "ndcDirectoryListed": false, "marketAvailability": "historical_discontinued_rld", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": null, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_10e511bf83430e3b", "label": "FDA Orange Book：TAPAZOLE／methimazole NDA 007517 的 5 mg 与 10 mg 历史 RLD 记录", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-tapazole-methimazole-10mg-tablet-nda-007517-product-004-historical", "marketCode": "US", "labelVersion": { "zh": "FDA Orange Book 当前数据中的历史产品身份（2026-08-29 核验）", "en": "Historical product identity in the current FDA Orange Book dataset (checked 29 Aug 2026)" }, "dosageForm": { "zh": "TAPAZOLE 甲巯咪唑 10 mg 口服片（美国历史 RLD）", "en": "TAPAZOLE methimazole 10 mg oral tablet (historical U.S. RLD)" }, "route": { "zh": "口服（历史监管产品身份字段）", "en": "oral (historical regulatory product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDA 007517 / Product 004", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片甲巯咪唑 10 mg；美国历史 RLD，当前列为停止销售", "en": "Methimazole 10 mg per tablet; historical U.S. RLD currently listed as discontinued" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "甲巯咪唑（methimazole）", "en": "methimazole" }, "value": 10, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片历史监管标示量；不是个人片数、频率或调药指令", "en": "historical regulatory amount per tablet; not an individual's tablet count, frequency or adjustment instruction" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-31", "currentLabelDisplayed": false, "ndcDirectoryListed": false, "marketAvailability": "historical_discontinued_rld", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": null, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_10e511bf83430e3b", "label": "FDA Orange Book：TAPAZOLE／methimazole NDA 007517 的 5 mg 与 10 mg 历史 RLD 记录", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "ca-tapazole-methimazole-5mg-tablet-din-00015741-historical", "marketCode": "CA", "labelVersion": { "zh": "Health Canada 产品专论 2025-12-19；DPD 状态 2026-07-16", "en": "Health Canada product monograph dated 19 Dec 2025; DPD status dated 16 Jul 2026" }, "dosageForm": { "zh": "TAPAZOLE 甲巯咪唑 5 mg 口服片（加拿大历史品牌记录）", "en": "TAPAZOLE methimazole 5 mg oral tablet (historical Canadian brand record)" }, "route": { "zh": "口服（加拿大历史监管产品身份字段）", "en": "oral (historical Canadian regulatory product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "DIN 00015741", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片甲巯咪唑 5 mg；DPD 于 2026-07-16 列为 Cancelled Post Market", "en": "Methimazole 5 mg per tablet; DPD listed Cancelled Post Market on 16 Jul 2026" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "甲巯咪唑（methimazole）", "en": "methimazole" }, "value": 5, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片产品专论标示量；不是个人片数、频率或调药指令", "en": "product-monograph amount per tablet; not an individual's tablet count, frequency or adjustment instruction" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-31", "currentLabelDisplayed": false, "ndcDirectoryListed": false, "marketAvailability": "cancelled_post_market", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": null, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_f569b57eee87a182", "label": "Health Canada：药品产品数据库（DPD）当前访问页；在库内核对 TAPAZOLE 5 mg／DIN 00015741", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_lookup_entry", "documentKind": "regulatory_lookup", "market": "CA", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-09-13", "reviewedAt": "2026-09-13" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "ca-tapazole-methimazole-10mg-tablet-din-02296039-historical", "marketCode": "CA", "labelVersion": { "zh": "Health Canada 产品专论 2025-12-19；DPD 状态 2026-07-16", "en": "Health Canada product monograph dated 19 Dec 2025; DPD status dated 16 Jul 2026" }, "dosageForm": { "zh": "TAPAZOLE 甲巯咪唑 10 mg 口服片（加拿大历史品牌记录）", "en": "TAPAZOLE methimazole 10 mg oral tablet (historical Canadian brand record)" }, "route": { "zh": "口服（加拿大历史监管产品身份字段）", "en": "oral (historical Canadian regulatory product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "DIN 02296039", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片甲巯咪唑 10 mg；DPD 于 2026-07-16 列为 Cancelled Post Market", "en": "Methimazole 10 mg per tablet; DPD listed Cancelled Post Market on 16 Jul 2026" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "甲巯咪唑（methimazole）", "en": "methimazole" }, "value": 10, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片产品专论标示量；不是个人片数、频率或调药指令", "en": "product-monograph amount per tablet; not an individual's tablet count, frequency or adjustment instruction" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-31", "currentLabelDisplayed": false, "ndcDirectoryListed": false, "marketAvailability": "cancelled_post_market", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": null, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_f569b57eee87a182", "label": "Health Canada：药品产品数据库（DPD）当前访问页；在库内核对 TAPAZOLE 10 mg／DIN 02296039", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_lookup_entry", "documentKind": "regulatory_lookup", "market": "CA", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-09-13", "reviewedAt": "2026-09-13" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "status": "withheld_repackaged_or_non_exact_visual", "title": { "zh": "没有取得与四个历史产品身份一一对应的官方包装主图", "en": "No official principal pack image was obtained one-to-one for the four historical product identities" }, "summary": { "zh": "本页只按 FDA Orange Book、Health Canada DPD 与产品专论列出美国和加拿大的 5 mg／10 mg 历史产品身份。没有用当前通用药、零售图片、旧广告或相似白色圆片替代品牌包装；药片颜色、刻印、包装数量和真伪必须以手中实际产品及对应现行说明书核对。", "en": "The page lists the historical U.S. and Canadian 5 mg / 10 mg product identities only from the FDA Orange Book, Health Canada DPD and product monograph. Current generics, retail images, old advertising and look-alike white round tablets are not substituted for brand packaging. Colour, imprint, pack count and authenticity require the actual product and its matching current label." }, "source": { "id": "src_683772cbdb239ed7", "label": "Health Canada：TAPAZOLE 5 mg／10 mg 产品专论与患者用药信息（2025-12-19）", "url": "https://pdf.hres.ca/dpd_pm/00082874.PDF", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-31", "reviewedAt": "2026-08-31" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "TAPAZOLE 说明书放大阅读：发热、寒战或咽痛不能只当普通感冒", "en": "TAPAZOLE label reading: fever, chills or sore throat must not be dismissed as an ordinary cold" }, "summary": { "zh": "产品专论把粒细胞缺乏和肝毒性列入严重警示。出现发热、寒战、咽痛、反复感染，或黄疸、深色尿、右上腹痛、异常乏力时，应按当地急诊与医疗体系及时评估；不要只靠网页自行停药、换药、补服或等待。", "en": "The product monograph places agranulocytosis and liver toxicity in the serious warnings. Fever, chills, sore throat, repeated infection, jaundice, dark urine, right-upper abdominal pain or unusual fatigue requires timely assessment through local urgent and clinical services. Do not use the website alone to stop, switch, make up or wait." }, "checks": [ { "zh": "5 mg 与 10 mg 是每片所含甲巯咪唑的量，不是一次该吃几片。个人方案与甲状腺功能、病因、年龄、孕期、其他药物及监测结果有关；网页不把化验值换算为片数。", "en": "5 mg and 10 mg are amounts of methimazole per tablet, not the number of tablets to take. An individual plan depends on thyroid function, cause, age, pregnancy, other medicines and monitoring results; the site does not convert laboratory values into tablet counts." }, { "zh": "发热、寒战、咽痛、口腔溃疡或频繁感染可能与严重白细胞减少有关。不要因症状像感冒就自行继续、停药或吃抗菌药掩盖；按说明书尽快联系开方团队或当地急诊服务。", "en": "Fever, chills, sore throat, mouth ulcers or frequent infection may relate to severe white-cell reduction. Do not self-continue, stop or mask it with an antibacterial because it resembles a cold; contact the prescriber or local urgent service promptly as directed by the label." }, { "zh": "皮肤或眼白发黄、深色尿、右上腹痛、持续恶心呕吐、食欲明显下降或异常乏力可能提示肝脏问题，需要及时专业评估。", "en": "Yellow skin or eyes, dark urine, right-upper abdominal pain, persistent nausea or vomiting, marked appetite loss or unusual fatigue may signal liver injury and needs prompt professional assessment." }, { "zh": "怀孕、准备怀孕或可能怀孕时应尽快告诉开方团队；说明书特别提示妊娠早期风险。网页不会替个人选择甲巯咪唑、丙硫氧嘧啶或其他方案。", "en": "Tell the prescribing team promptly about pregnancy, plans for pregnancy or possible pregnancy; the label highlights first-trimester risk. The site does not choose methimazole, propylthiouracil or another option for an individual." }, { "zh": "华法林或其他抗凝药、茶碱，以及可能影响白细胞、肝脏或甲状腺状态的药物都应放在同一张完整药单里核对。甲状腺状态变化本身也可能改变联用药的监测需求。", "en": "Warfarin or another anticoagulant, theophylline and medicines that may affect white cells, liver or thyroid status belong on one complete list for review. Changes in thyroid status itself may alter monitoring needs for co-medications." }, { "zh": "历史 TAPAZOLE 品牌记录与当前同成分通用药不是同一个可视包装。不能只凭“白色圆片”“有刻痕”或相同 mg 判断真伪、厂牌或可替代性。", "en": "The historical TAPAZOLE brand records and current same-ingredient generics are not one visual package. A white round tablet, a score or the same mg figure cannot establish authenticity, manufacturer or interchangeability." } ], "source": { "id": "src_683772cbdb239ed7", "label": "Health Canada：TAPAZOLE 5 mg／10 mg 产品专论与患者用药信息（2025-12-19）", "url": "https://pdf.hres.ca/dpd_pm/00082874.PDF", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-31", "reviewedAt": "2026-08-31" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "甲巯咪唑怎样起作用：减少新甲状腺激素的合成，不会立刻清除已经存在的激素", "en": "How methimazole works: it reduces new thyroid-hormone synthesis but does not immediately remove hormone already present" }, "summary": { "zh": "产品专论说明甲巯咪唑抑制甲状腺激素合成，但不会使甲状腺或血液中已经储存、循环的甲状腺激素失活。因此症状改善可能需要时间；作用机理不能用来自行加量、停药或判断已经恢复正常。", "en": "The product monograph explains that methimazole inhibits thyroid-hormone synthesis but does not inactivate hormone already stored in the thyroid or circulating in blood. Improvement may therefore take time; the mechanism cannot be used to self-increase, stop or decide that thyroid status has normalised." }, "checks": [ { "zh": "心悸、手抖、怕热、体重或睡眠变化可能来自甲亢、甲减、其他疾病或药物；症状相似不等于应该把抗甲状腺药与左甲状腺素自行叠加、轮换或抵消。", "en": "Palpitations, tremor, heat intolerance, weight or sleep change may arise from hyperthyroidism, hypothyroidism, another illness or medicines. Similar symptoms do not justify self-combining, alternating or offsetting an antithyroid medicine with levothyroxine." }, { "zh": "甲巯咪唑、丙硫氧嘧啶和卡比马唑不是按毫克一比一互换的同一种产品；品牌、活性成分、强度、市场和说明书必须一起核对。", "en": "Methimazole, propylthiouracil and carbimazole are not one product interchangeable milligram for milligram. Brand, active ingredient, strength, market and label must be checked together." }, { "zh": "网页解释“为什么要监测”，但不解释个人化验单，也不提供停药、减量、补服、交替或疗程结论。", "en": "The page explains why monitoring matters but does not interpret an individual's laboratory results or provide stopping, reduction, make-up, alternating or course decisions." } ], "source": { "id": "src_683772cbdb239ed7", "label": "Health Canada：TAPAZOLE 5 mg／10 mg 产品专论与患者用药信息（2025-12-19）", "url": "https://pdf.hres.ca/dpd_pm/00082874.PDF", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-31", "reviewedAt": "2026-08-31" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "TAPAZOLE", "generic": "甲巯咪唑（甲硫咪唑）", "dosageFormClass": "历史品牌口服片：每片甲巯咪唑 5 mg 或 10 mg；5 mg 与 10 mg 是每片含量，不是网页给出的个人片数；美国、加拿大及当前通用药记录必须分开核对。" }, "labelSource": { "id": "src_683772cbdb239ed7", "label": "Health Canada：TAPAZOLE 5 mg／10 mg 产品专论与患者用药信息（2025-12-19）", "url": "https://pdf.hres.ca/dpd_pm/00082874.PDF", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-31", "reviewedAt": "2026-08-31" }, "productRoutes": [ { "source": { "id": "src_683772cbdb239ed7", "label": "Health Canada：TAPAZOLE 5 mg／10 mg 产品专论与患者用药信息（2025-12-19）", "url": "https://pdf.hres.ca/dpd_pm/00082874.PDF", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-31", "reviewedAt": "2026-08-31" }, "status": "product_level_public_record_verified", "authority": { "zh": "Health Canada", "en": "Health Canada" }, "market": { "zh": "加拿大", "en": "Canada" }, "recordType": { "zh": "监管产品记录或当前产品专论", "en": "Regulatory product record or current product monograph" }, "reviewedAt": "2026-08-31", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_10e511bf83430e3b", "label": "FDA Orange Book：TAPAZOLE／methimazole NDA 007517 的 5 mg 与 10 mg 历史 RLD 记录", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-08-29", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "Health Canada", "en": "Health Canada" }, "market": { "zh": "加拿大", "en": "Canada" }, "recordType": { "zh": "监管产品记录或当前产品专论", "en": "Regulatory product record or current product monograph" }, "reviewedAt": "2026-08-31", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "TAPAZOLE 是甲巯咪唑历史品牌档案，用于帮助读懂抗甲状腺药说明书。最重要的不是从 5 mg 或 10 mg 自行算片数，而是知道发热、寒战、咽痛或反复感染可能提示严重白细胞问题；黄疸、深色尿、右上腹痛或异常乏力可能提示肝脏问题，需要按现行标签尽快联系医疗团队。", "history": "Health Canada 记录 TAPAZOLE 5 mg 最早市场日期为 1951-12-31，10 mg 为 2008-01-07；两项 DIN 均在 2026-07-16 转为 Cancelled Post Market。美国 NDA 007517 的 5 mg 与 10 mg 产品批准早于 1982，当前 Orange Book 列为 DISCN，并注明 FDA 判定并非因安全性或有效性撤回。历史品牌状态不等于当前库存；当前通用药须按实际厂牌、DIN/NDC、说明书和药片外观另行核对。", "sourceDocuments": [ { "id": "src_10e511bf83430e3b", "label": "FDA Orange Book：TAPAZOLE／methimazole NDA 007517 的 5 mg 与 10 mg 历史 RLD 记录", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, { "id": "src_f569b57eee87a182", "label": "Health Canada：药品产品数据库（DPD）当前访问页；在库内核对 TAPAZOLE 5 mg／DIN 00015741", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_lookup_entry", "documentKind": "regulatory_lookup", "market": "CA", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-09-13", "reviewedAt": "2026-09-13" }, { "id": "src_f569b57eee87a182", "label": "Health Canada：药品产品数据库（DPD）当前访问页；在库内核对 TAPAZOLE 10 mg／DIN 02296039", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_lookup_entry", "documentKind": "regulatory_lookup", "market": "CA", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-09-13", "reviewedAt": "2026-09-13" }, { "id": "src_683772cbdb239ed7", "label": "Health Canada：TAPAZOLE 5 mg／10 mg 产品专论与患者用药信息（2025-12-19）", "url": "https://pdf.hres.ca/dpd_pm/00082874.PDF", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-31", "reviewedAt": "2026-08-31" }, { "id": "src_f569b57eee87a182", "label": "Health Canada：药品产品数据库（DPD）当前访问页；在库内按甲巯咪唑 5 mg 核对", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_lookup_entry", "documentKind": "regulatory_lookup", "market": "CA", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-09-13", "reviewedAt": "2026-09-13" }, { "id": "src_f569b57eee87a182", "label": "Health Canada：药品产品数据库（DPD）当前访问页；在库内按甲巯咪唑 10 mg 核对", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_lookup_entry", "documentKind": "regulatory_lookup", "market": "CA", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-09-13", "reviewedAt": "2026-09-13" } ], "applicationNumber": "美国历史 NDA 007517；加拿大 DIN 00015741 / 02296039", "approvalTimeline": [ { "date": "1951-12-31", "title": { "zh": "加拿大 TAPAZOLE 5 mg 最早市场日期", "en": "Earliest Canadian market date for TAPAZOLE 5 mg" }, "detail": { "zh": "Health Canada DPD 记录 DIN 00015741 的最早市场日期为 1951-12-31；这是历史品牌时间线，不证明当前供应。", "en": "Health Canada DPD records 31 Dec 1951 as the earliest market date for DIN 00015741. This is historical brand chronology, not current supply." }, "source": { "id": "src_f569b57eee87a182", "label": "Health Canada：药品产品数据库（DPD）当前访问页；在库内核对 TAPAZOLE 5 mg／DIN 00015741", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_lookup_entry", "documentKind": "regulatory_lookup", "market": "CA", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-09-13", "reviewedAt": "2026-09-13" } }, { "date": "Approved prior to 1982", "title": { "zh": "美国 TAPAZOLE NDA 007517 历史批准", "en": "Historical U.S. approval of TAPAZOLE NDA 007517" }, "detail": { "zh": "Orange Book 将 5 mg 与 10 mg 历史产品列为 RLD、DISCN，并注明并非因安全性或有效性撤回。", "en": "Orange Book lists the historical 5 mg and 10 mg products as RLD and discontinued, with a determination that they were not withdrawn for safety or effectiveness reasons." }, "source": { "id": "src_10e511bf83430e3b", "label": "FDA Orange Book：TAPAZOLE／methimazole NDA 007517 的 5 mg 与 10 mg 历史 RLD 记录", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } }, { "date": "2025-12-19", "title": { "zh": "加拿大产品专论修订", "en": "Canadian product monograph revised" }, "detail": { "zh": "有日期产品专论覆盖 5 mg 与 10 mg 片、严重警示、患者用药信息和药物机理；可读文件不等于当前品牌供应。", "en": "The dated monograph covers 5 mg and 10 mg tablets, serious warnings, patient information and mechanism. An accessible document does not establish current brand supply." }, "source": { "id": "src_683772cbdb239ed7", "label": "Health Canada：TAPAZOLE 5 mg／10 mg 产品专论与患者用药信息（2025-12-19）", "url": "https://pdf.hres.ca/dpd_pm/00082874.PDF", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-31", "reviewedAt": "2026-08-31" } }, { "date": "2026-07-16", "title": { "zh": "加拿大 5 mg 与 10 mg 品牌 DIN 转为上市后取消", "en": "Canadian 5 mg and 10 mg brand DINs moved to Cancelled Post Market" }, "detail": { "zh": "DPD 对 DIN 00015741 与 02296039 均显示 Cancelled Post Market。本页以实时 DPD 覆盖 2026-08-26 导入索引中的旧 Marketed 状态。", "en": "DPD displays Cancelled Post Market for DIN 00015741 and 02296039. This live status supersedes the stale Marketed value in the imported 26 Aug 2026 index." }, "source": { "id": "src_f569b57eee87a182", "label": "Health Canada：药品产品数据库（DPD）当前访问页；在库内核对 TAPAZOLE 10 mg／DIN 02296039", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_lookup_entry", "documentKind": "regulatory_lookup", "market": "CA", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-09-13", "reviewedAt": "2026-09-13" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "历史 RLD，当前停止销售", "en": "Historical RLD; currently discontinued" }, "detail": { "zh": "5 mg 与 10 mg 产品均为 NDA 007517 历史 RLD、DISCN；不是当前品牌库存或购买入口。", "en": "The 5 mg and 10 mg products are historical RLDs under NDA 007517 and are listed discontinued; this is not current brand stock or a purchase route." } }, { "market": { "zh": "加拿大", "en": "Canada" }, "status": { "zh": "品牌 5 mg 与 10 mg 均为 Cancelled Post Market", "en": "Brand 5 mg and 10 mg both Cancelled Post Market" }, "detail": { "zh": "DPD 状态日期均为 2026-07-16。相同成分的当前 Marketed 通用药需按各自 DIN 和说明书核对，不能继承 TAPAZOLE 包装身份。", "en": "Both DPD status dates are 16 Jul 2026. Current marketed same-ingredient generics require their own DIN and label review and do not inherit TAPAZOLE package identity." } }, { "market": { "zh": "中国大陆、欧盟、日本及其他市场", "en": "Mainland China, EU, Japan and other markets" }, "status": { "zh": "待逐项建立现行市场记录", "en": "Current market record not established" }, "detail": { "zh": "不从 methimazole、thiamazole、甲巯咪唑或甲硫咪唑名称推定当地品牌、批准、供应、包装、真伪或可替代性。", "en": "No local brand, approval, supply, packaging, authenticity or interchangeability is inferred from the names methimazole, thiamazole, 甲巯咪唑 or 甲硫咪唑." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "发热和咽痛只是感冒吗？", "en": "Are fever and sore throat just a cold?" }, "answer": { "zh": "服用甲巯咪唑时不能只按普通感冒处理，因为说明书将发热、寒战、咽痛和频繁感染列为粒细胞缺乏的警示表现。请按标签尽快联系开方团队或当地急诊服务；网页不能替代血液检查。", "en": "While taking methimazole, these cannot be treated as an ordinary cold alone because the label lists fever, chills, sore throat and frequent infection as warning features of agranulocytosis. Contact the prescriber or local urgent service promptly as directed by the label; the site cannot replace a blood test." } }, { "question": { "zh": "5 mg 片掰成两半就等于 2.5 mg，可以自己这样做吗？", "en": "Does halving a 5 mg tablet equal 2.5 mg, and can I do that myself?" }, "answer": { "zh": "不能从网页自行决定。旧品牌、当前通用药、刻痕、含量均可能不同；能否分片以及个人处方必须由药师根据手中准确产品说明书和开方指示核对。", "en": "Do not decide this from the website. Historical brand and current generic products, scores and labelled amounts may differ. A pharmacist must check the exact product label and prescription before any splitting decision." } }, { "question": { "zh": "甲状腺指标正常后可以马上停药吗？", "en": "Can the medicine be stopped immediately once thyroid tests are normal?" }, "answer": { "zh": "不要自行停药。甲巯咪唑影响新激素合成，已有激素、病因、复发风险和监测计划仍需专业判断；网页不解释个人化验结果或制定停药方案。", "en": "Do not self-stop. Methimazole affects new hormone synthesis, while existing hormone, disease cause, relapse risk and the monitoring plan still require professional judgement. The site does not interpret personal results or create a stopping plan." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "dose-unit-literacy", "same-class-is-not-same-medicine" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/tapazole/", "en": "https://origindrug.com/en/drugs/tapazole/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "carafate-sucralfate", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-31", "status": "published_traceable_archive" }, "names": { "brand": "CARAFATE", "generic": "硫糖铝", "aliases": [ "Carafate", "sucralfate", "硫糖铝", "硫糖铝片", "硫糖铝口服混悬液", "NDA 018333", "NDA 019183" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "消化系统", "sourceArchiveMarket": "美国：CARAFATE 1 g 片剂 NDA 018333 在 Orange Book 列为处方 RLD/RS，DailyMed 有当前公开标签；1 g/10 mL 口服混悬液属于 NDA 019183，Orange Book 当前列为 DISCN，虽仍有 2023 年公开标签档案，也不能写成实时库存。", "dosageFormClass": "片剂按每片 1 g 标示；混悬液按每 10 mL 含 1 g 标示。1 g 等于 1000 mg 只是单位换算，不是个人片数、毫升数、频次或疗程。", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "1981（美国片剂标签营销起始日期）", "archiveSponsorText": "AbbVie, Inc. / Allergan, Inc.（DailyMed 当前美国标签所列）" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [ "CARAFATE", "Carafate sucralfate", "硫糖铝" ], "excludedProductCues": [ "aluminum hydroxide", "氢氧化铝", "omeprazole", "famotidine", "bismuth", "铋剂" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-carafate-1g-tablet-58914-171-10", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前 SPL；处方信息修订 2024-05", "en": "Current DailyMed SPL; prescribing information revised May 2024" }, "dosageForm": { "zh": "CARAFATE 硫糖铝 1 g 口服片", "en": "CARAFATE sucralfate 1 g oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDA 018333 / NDC 58914-171-10", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片硫糖铝 1 g；100 片瓶装", "en": "Sucralfate 1 g per tablet; 100-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=carafate-tablets-02.jpg&setid=c87c6b50-6977-4fa7-ae98-40c0753f7aee", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "硫糖铝", "en": "sucralfate" }, "value": 1, "unit": "g", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数或频次", "en": "labelled amount per tablet; not an individual's tablet count or frequency" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-31", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "current_public_label_record", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": null, "physicalClues": { "color": { "zh": "浅粉色", "en": "light pink" }, "shape": { "zh": "长椭圆形、有刻痕；刻痕不是自行掰片许可", "en": "oblong and scored; the score is not permission to self-split" }, "imprint": "CARAFATE / 1712", "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_76220245f3288cb9", "label": "DailyMed（NLM）：CARAFATE 1 g 片剂当前美国公开标签", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c87c6b50-6977-4fa7-ae98-40c0753f7aee", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-31", "reviewedAt": "2026-08-31" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-carafate-1g-per-10ml-suspension-nda-019183", "marketCode": "US", "labelVersion": { "zh": "DailyMed 2023-06-08 有日期标签；Orange Book 当前 DISCN", "en": "Dated DailyMed label of 8 Jun 2023; currently DISCN in Orange Book" }, "dosageForm": { "zh": "CARAFATE 硫糖铝 1 g/10 mL 口服混悬液（历史身份）", "en": "CARAFATE sucralfate 1 g/10 mL oral suspension (historical identity)" }, "route": { "zh": "仅口服", "en": "oral only" }, "routeCodes": [ "oral" ], "productCode": "NDA 019183 / NDC 58914-170", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_10_ml", "primaryDisplay": { "zh": "每 10 mL 含硫糖铝 1 g；不是个人毫升数", "en": "Sucralfate 1 g per 10 mL; not an individual's millilitres" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=carafate-oral-suspension-02.jpg&setid=0fb67b1c-b4c0-46f2-8a81-df1510e006aa", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "硫糖铝", "en": "sucralfate" }, "value": 1, "unit": "g", "basisCode": "per_10_ml", "basisLabel": { "zh": "每 10 mL 标签浓度；不是个人用量", "en": "labelled concentration per 10 mL; not an individual's amount" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-31", "currentLabelDisplayed": false, "ndcDirectoryListed": false, "marketAvailability": "historical_discontinued_orange_book_record", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": null, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_1187e6edc0397419", "label": "DailyMed（NLM）：CARAFATE 1 g/10 mL 口服混悬液美国公开标签档案", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=0fb67b1c-b4c0-46f2-8a81-df1510e006aa", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-31", "reviewedAt": "2026-08-31" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-carafate-1g-tablet-58914-171-10", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=carafate-tablets-02.jpg&setid=c87c6b50-6977-4fa7-ae98-40c0753f7aee", "alt": "美国当前 CARAFATE 硫糖铝片每片 1 g、NDC 58914-171-10、100 片瓶装的 DailyMed 官方标签展示面", "archiveMarket": "美国", "labelVersion": "DailyMed 当前 SPL；处方信息修订 2024-05", "presentation": "CARAFATE 硫糖铝片：每片 1 g，NDC 58914-171-10，100 片瓶装。", "notice": "此图只对应所引 DailyMed 当前标签中的美国 1 g 片剂、NDC 58914-171-10、100 片瓶装；不代表口服混悬液、中国大陆或其他市场包装、实时库存及个人适用性，不用于鉴定真伪，也不生成个人片数、频次或与其他药物的间隔方案。", "source": { "id": "src_76220245f3288cb9", "label": "DailyMed（NLM）：CARAFATE 1 g 片剂当前美国公开标签", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c87c6b50-6977-4fa7-ae98-40c0753f7aee", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-31", "reviewedAt": "2026-08-31" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "CARAFATE 说明书放大阅读：先核对吞咽、肾功能与完整药单", "en": "CARAFATE enlarged label: first check swallowing, kidney function and the complete medicine list" }, "summary": { "zh": "硫糖铝虽主要在胃肠道局部作用，但会结合某些合并用药并降低其吸收；肾功能不全或透析人群还需关注铝蓄积。网页不自动生成错开时间表。", "en": "Although sucralfate acts mainly in the gut, it can bind some co-medications and reduce absorption; aluminum accumulation also matters in renal impairment or dialysis. The site does not generate a personal separation schedule." }, "checks": [ { "zh": "1 g 片剂与 1 g/10 mL 混悬液的计量基础不同；标签明确指出两种剂型的等效性未被证明，不能自行用 10 mL 换一片。", "en": "The 1 g tablet and 1 g/10 mL suspension use different quantity bases; the label says equivalence has not been demonstrated, so 10 mL must not be self-exchanged for one tablet." }, { "zh": "吞咽困难、气管切开、既往误吸、近期或长期插管，或咳嗽/咽反射受影响的人，片剂存在误吸与呼吸并发症风险，应先由专业人员核对剂型。", "en": "With dysphagia, tracheostomy, prior aspiration, intubation, or impaired cough/gag reflex, tablet aspiration and respiratory complications require professional dosage-form review." }, { "zh": "慢性肾功能不全或透析会降低所吸收铝的排出；同时使用含铝制酸剂可能增加总铝负担。", "en": "Chronic renal failure or dialysis reduces excretion of absorbed aluminum, and aluminum-containing antacids may increase total burden." }, { "zh": "标签列出的相互作用对象包括地高辛、氟喹诺酮类、左甲状腺素、苯妥英、四环素、茶碱和华法林等。不要只凭网页自行安排间隔；请让药师核对完整药单。", "en": "The label lists interaction concerns including digoxin, fluoroquinolones, levothyroxine, phenytoin, tetracycline, theophylline and warfarin. Do not create a separation schedule from the site alone; have a pharmacist review the complete list." } ], "source": { "id": "src_76220245f3288cb9", "label": "DailyMed（NLM）：CARAFATE 1 g 片剂当前美国公开标签", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c87c6b50-6977-4fa7-ae98-40c0753f7aee", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-31", "reviewedAt": "2026-08-31" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "硫糖铝怎样起作用：主要形成覆盖溃疡部位的局部屏障", "en": "How sucralfate works: mainly by forming a local barrier over the ulcer site" }, "summary": { "zh": "标签说明其全身吸收很少，并可在溃疡处形成黏附复合物，帮助抵御酸、胃蛋白酶和胆盐。它不是简单的“强力中和胃酸”，也不能据此自行与抑酸药叠加或替换。", "en": "The label says systemic absorption is minimal and describes an ulcer-adherent complex that helps protect against acid, pepsin and bile salts. This does not justify self-adding or replacing acid-suppressing medicines." }, "checks": [ { "zh": "黑便、呕血、吞咽困难、持续呕吐或明显乏力需要及时医疗评估，不能只靠“形成保护膜”的解释自行处理。", "en": "Black stools, vomiting blood, dysphagia, persistent vomiting or marked fatigue requires timely clinical assessment, not self-treatment from a barrier explanation." }, { "zh": "局部作用不等于没有相互作用；硫糖铝可在胃肠道结合其他药物，因此必须核对完整药单。", "en": "Local action does not mean no interactions; sucralfate can bind other medicines in the gastrointestinal tract, so the complete medicine list must be reviewed." }, { "zh": "同样用于胃部不适的质子泵抑制剂、H2 受体阻滞剂、制酸剂和铋剂具有不同成分与作用路径，不能按症状或品牌自行叠加、轮换或替代。", "en": "Proton-pump inhibitors, H2 blockers, antacids and bismuth products used for stomach concerns have different ingredients and pathways and must not be self-combined, alternated or substituted from symptoms or brands." } ], "source": { "id": "src_76220245f3288cb9", "label": "DailyMed（NLM）：CARAFATE 1 g 片剂当前美国公开标签", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c87c6b50-6977-4fa7-ae98-40c0753f7aee", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-31", "reviewedAt": "2026-08-31" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "CARAFATE", "generic": "硫糖铝", "dosageFormClass": "片剂按每片 1 g 标示；混悬液按每 10 mL 含 1 g 标示。1 g 等于 1000 mg 只是单位换算，不是个人片数、毫升数、频次或疗程。" }, "labelSource": { "id": "src_76220245f3288cb9", "label": "DailyMed（NLM）：CARAFATE 1 g 片剂当前美国公开标签", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c87c6b50-6977-4fa7-ae98-40c0753f7aee", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-31", "reviewedAt": "2026-08-31" }, "productRoutes": [ { "source": { "id": "src_76220245f3288cb9", "label": "DailyMed（NLM）：CARAFATE 1 g 片剂当前美国公开标签", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c87c6b50-6977-4fa7-ae98-40c0753f7aee", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-31", "reviewedAt": "2026-08-31" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-31", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_1187e6edc0397419", "label": "DailyMed（NLM）：CARAFATE 1 g/10 mL 口服混悬液美国公开标签档案", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=0fb67b1c-b4c0-46f2-8a81-df1510e006aa", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-31", "reviewedAt": "2026-08-31" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-31", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_10e511bf83430e3b", "label": "FDA Orange Book：CARAFATE／sucralfate NDA 018333 片剂与 NDA 019183 混悬液产品身份", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-08-29", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-31", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "CARAFATE 是硫糖铝品牌档案。它主要在胃肠道局部形成保护性屏障，但仍可能影响其他药物吸收；吞咽困难、肾功能不全、透析或同时服用多种药的人，应把完整药单和实际药盒交给药师逐项核对。", "history": "美国片剂标签记录营销起始日期为 1981-10-30。口服混悬液 1993-12-16 起有标签记录，但当前 Orange Book 为 DISCN。本页把当前片剂与历史混悬液拆开，不把公开旧标签等同于当前供应。", "sourceDocuments": [ { "id": "src_76220245f3288cb9", "label": "DailyMed（NLM）：CARAFATE 1 g 片剂当前美国公开标签", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c87c6b50-6977-4fa7-ae98-40c0753f7aee", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-31", "reviewedAt": "2026-08-31" }, { "id": "src_1187e6edc0397419", "label": "DailyMed（NLM）：CARAFATE 1 g/10 mL 口服混悬液美国公开标签档案", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=0fb67b1c-b4c0-46f2-8a81-df1510e006aa", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-31", "reviewedAt": "2026-08-31" }, { "id": "src_10e511bf83430e3b", "label": "FDA Orange Book：CARAFATE／sucralfate NDA 018333 片剂与 NDA 019183 混悬液产品身份", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } ], "applicationNumber": "NDA 018333（片剂）/ NDA 019183（混悬液）", "approvalTimeline": [ { "date": "1981-10-30", "title": { "zh": "美国 CARAFATE 片剂标签营销起始记录", "en": "U.S. CARAFATE tablet label marketing-start record" }, "detail": { "zh": "DailyMed 当前结构化标签把 NDA 018333、NDC 58914-171-10 与该日期关联；这是监管与标签身份，不是全球供应证明。", "en": "The current structured DailyMed label links NDA 018333 and NDC 58914-171-10 to this date; this is regulatory and label identity, not proof of global supply." }, "source": { "id": "src_76220245f3288cb9", "label": "DailyMed（NLM）：CARAFATE 1 g 片剂当前美国公开标签", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c87c6b50-6977-4fa7-ae98-40c0753f7aee", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-31", "reviewedAt": "2026-08-31" } }, { "date": "1993-12-16", "title": { "zh": "美国 CARAFATE 口服混悬液标签营销起始记录", "en": "U.S. CARAFATE oral-suspension label marketing-start record" }, "detail": { "zh": "DailyMed 标签档案记录 NDA 019183 的 1 g/10 mL 产品；Orange Book 当前 DISCN 状态优先用于解释现行监管目录。", "en": "The DailyMed label archive records the 1 g/10 mL product under NDA 019183; the current Orange Book DISCN status governs interpretation of the current approval catalogue." }, "source": { "id": "src_1187e6edc0397419", "label": "DailyMed（NLM）：CARAFATE 1 g/10 mL 口服混悬液美国公开标签档案", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=0fb67b1c-b4c0-46f2-8a81-df1510e006aa", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-31", "reviewedAt": "2026-08-31" } }, { "date": "2024-05", "title": { "zh": "片剂处方信息修订", "en": "Tablet prescribing information revised" }, "detail": { "zh": "现行片剂标签覆盖产品外观、吞咽误吸、肾功能与合并用药吸收等重点。", "en": "The current tablet label covers product appearance, aspiration with swallowing impairment, renal considerations and co-medication absorption." }, "source": { "id": "src_76220245f3288cb9", "label": "DailyMed（NLM）：CARAFATE 1 g 片剂当前美国公开标签", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c87c6b50-6977-4fa7-ae98-40c0753f7aee", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-31", "reviewedAt": "2026-08-31" } } ], "marketStatus": [ { "market": { "zh": "美国片剂", "en": "U.S. tablet" }, "status": { "zh": "当前公开标签；Orange Book RLD/RS", "en": "Current public label; Orange Book RLD/RS" }, "detail": { "zh": "1 g 每片，NDC 58914-171-10。", "en": "1 g per tablet, NDC 58914-171-10." } }, { "market": { "zh": "美国混悬液", "en": "U.S. suspension" }, "status": { "zh": "有日期标签档案；Orange Book DISCN", "en": "Dated label archive; Orange Book DISCN" }, "detail": { "zh": "1 g/10 mL 是浓度，不代表当前库存。", "en": "1 g/10 mL is a concentration and does not establish current stock." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "1 g 是不是就是一次吃一片？", "en": "Does 1 g mean one tablet each time?" }, "answer": { "zh": "不是。1 g 是每片标签含量；混悬液的 1 g/10 mL 是浓度。个人片数、毫升数和频次必须以准确处方与现行标签核对。", "en": "No. One gram is the labelled amount per tablet, while 1 g/10 mL is a concentration. Individual tablet count, millilitres and frequency require the exact prescription and current label." } }, { "question": { "zh": "药太多，网页能自动告诉我怎么错开吗？", "en": "Can the site automatically tell me how to separate many medicines?" }, "answer": { "zh": "不能。请带完整药单、药盒和处方让药师制定可执行的时间表。", "en": "No. Take the complete list, packs and prescription to a pharmacist for an actionable schedule." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "dose-unit-literacy", "same-class-is-not-same-medicine" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/carafate-sucralfate/", "en": "https://origindrug.com/en/drugs/carafate-sucralfate/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "onglyza-saxagliptin", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-31", "status": "published_traceable_archive" }, "names": { "brand": "ONGLYZA", "generic": "沙格列汀", "aliases": [ "Onglyza", "saxagliptin", "saxagliptin hydrochloride", "沙格列汀", "安立泽", "NDA 022350", "DIN 02375842", "DIN 02333554" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "代谢", "sourceArchiveMarket": "美国 FDA Orange Book：ONGLYZA 2.5 mg 与 5 mg 片均为 NDA 022350 历史 RLD、当前 DISCN，且并非因安全性或有效性撤回；加拿大 Health Canada DPD：5 mg（DIN 02333554）与 2.5 mg（DIN 02375842）均为 Marketed。公开美国标签用于说明书阅读，不等于美国当前库存。", "dosageFormClass": "薄膜衣口服片：每片相当于沙格列汀 2.5 mg 或 5 mg。标签明确不得掰开或切开；两个规格不是网页替个人选择或换算的方案。", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "2009（美国初始批准）", "archiveSponsorText": "AstraZeneca（美国历史 NDA／加拿大当前 DPD 品牌记录）" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [ "ONGLYZA", "Onglyza saxagliptin", "沙格列汀", "安立泽" ], "excludedProductCues": [ "KOMBIGLYZE XR", "saxagliptin metformin", "QTERN", "dapagliflozin saxagliptin", "QTERNMET XR", "JANUVIA", "TRADJENTA" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-onglyza-saxagliptin-2-5mg-ndc-0310-6100-30-nda-022350", "marketCode": "US", "labelVersion": { "zh": "美国公开标签档案；Orange Book 当前 DISCN", "en": "U.S. public-label archive; currently DISCN in Orange Book" }, "dosageForm": { "zh": "ONGLYZA 沙格列汀 2.5 mg 薄膜衣口服片", "en": "ONGLYZA saxagliptin 2.5 mg film-coated oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 0310-6100-30 / NDA 022350", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片相当于沙格列汀 2.5 mg；不是个人片数", "en": "Equivalent to saxagliptin 2.5 mg per tablet; not an individual's tablet count" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=image-02.jpg&archiveid=933594", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "沙格列汀（以盐酸盐计）", "en": "saxagliptin (as hydrochloride)" }, "value": 2.5, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人频次或调整方案", "en": "labelled amount per tablet; not an individual's frequency or adjustment plan" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-31", "currentLabelDisplayed": false, "ndcDirectoryListed": false, "marketAvailability": "historical_discontinued_rld", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": null, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_f4553a4ff5a41d73", "label": "DailyMed（NLM）：ONGLYZA 2.5 mg／5 mg 美国有日期包装面板（AstraZeneca；2025-12 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=c5116390-e0fe-4969-94cb-e9de5165fbab&type=display", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-31", "reviewedAt": "2026-08-31" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-onglyza-saxagliptin-5mg-ndc-0310-6105-30-nda-022350", "marketCode": "US", "labelVersion": { "zh": "美国公开标签档案；Orange Book 当前 DISCN", "en": "U.S. public-label archive; currently DISCN in Orange Book" }, "dosageForm": { "zh": "ONGLYZA 沙格列汀 5 mg 薄膜衣口服片", "en": "ONGLYZA saxagliptin 5 mg film-coated oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 0310-6105-30 / NDA 022350", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片相当于沙格列汀 5 mg；不是个人片数", "en": "Equivalent to saxagliptin 5 mg per tablet; not an individual's tablet count" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=image-01.jpg&archiveid=933594", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "沙格列汀（以盐酸盐计）", "en": "saxagliptin (as hydrochloride)" }, "value": 5, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人频次或调整方案", "en": "labelled amount per tablet; not an individual's frequency or adjustment plan" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-31", "currentLabelDisplayed": false, "ndcDirectoryListed": false, "marketAvailability": "historical_discontinued_rld", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": null, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_f4553a4ff5a41d73", "label": "DailyMed（NLM）：ONGLYZA 2.5 mg／5 mg 美国有日期包装面板（AstraZeneca；2025-12 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=c5116390-e0fe-4969-94cb-e9de5165fbab&type=display", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-31", "reviewedAt": "2026-08-31" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "ca-onglyza-saxagliptin-2-5mg-din-02375842", "marketCode": "CA", "labelVersion": { "zh": "Health Canada DPD 当前 Marketed 记录（2026-07-29 数据更新）", "en": "Current Health Canada DPD Marketed record (data updated 29 Jul 2026)" }, "dosageForm": { "zh": "ONGLYZA 沙格列汀 2.5 mg 薄膜衣口服片", "en": "ONGLYZA saxagliptin 2.5 mg film-coated oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "DIN 02375842", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片相当于沙格列汀 2.5 mg；不是个人片数", "en": "Equivalent to saxagliptin 2.5 mg per tablet; not an individual's tablet count" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "沙格列汀（以盐酸盐计）", "en": "saxagliptin (as hydrochloride)" }, "value": 2.5, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人频次或调整方案", "en": "labelled amount per tablet; not an individual's frequency or adjustment plan" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-31", "currentLabelDisplayed": true, "ndcDirectoryListed": false, "marketAvailability": "current_marketed", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": null, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_f569b57eee87a182", "label": "Health Canada：药品产品数据库（DPD）当前访问页；在库内核对 ONGLYZA 2.5 mg／5 mg", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_lookup_entry", "documentKind": "regulatory_lookup", "market": "CA", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-09-13", "reviewedAt": "2026-09-13" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "ca-onglyza-saxagliptin-5mg-din-02333554", "marketCode": "CA", "labelVersion": { "zh": "Health Canada DPD 当前 Marketed 记录（2026-07-29 数据更新）", "en": "Current Health Canada DPD Marketed record (data updated 29 Jul 2026)" }, "dosageForm": { "zh": "ONGLYZA 沙格列汀 5 mg 薄膜衣口服片", "en": "ONGLYZA saxagliptin 5 mg film-coated oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "DIN 02333554", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片相当于沙格列汀 5 mg；不是个人片数", "en": "Equivalent to saxagliptin 5 mg per tablet; not an individual's tablet count" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "沙格列汀（以盐酸盐计）", "en": "saxagliptin (as hydrochloride)" }, "value": 5, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人频次或调整方案", "en": "labelled amount per tablet; not an individual's frequency or adjustment plan" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-31", "currentLabelDisplayed": true, "ndcDirectoryListed": false, "marketAvailability": "current_marketed", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": null, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_f569b57eee87a182", "label": "Health Canada：药品产品数据库（DPD）当前访问页；在库内核对 ONGLYZA 2.5 mg／5 mg", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_lookup_entry", "documentKind": "regulatory_lookup", "market": "CA", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-09-13", "reviewedAt": "2026-09-13" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "status": "withheld_repackaged_or_non_exact_visual", "title": { "zh": "未取得与四个市场产品身份逐一对应的当前官方包装主图", "en": "No current official principal pack image was obtained one-to-one for all four market identities" }, "summary": { "zh": "页面下方单列两张美国有日期历史包装面板：5 mg 对应 NDC 0310-6105-30，标签列示营销终止日为 2026-03-31；2.5 mg 对应 NDC 0310-6100-30，标签列示营销终止日为 2025-08-31。加拿大当前包装可能不同，因此这些美国历史面板不替代加拿大现行药盒，也不证明库存、可购买性或个人适用。", "en": "Two dated U.S. historical package panels are separately displayed below: 5 mg corresponds to NDC 0310-6105-30, whose label lists a marketing end date of 31 Mar 2026; 2.5 mg corresponds to NDC 0310-6100-30, whose label lists 31 Aug 2025. Current Canadian packs may differ, so these U.S. historical panels do not substitute for current Canadian packaging or establish stock, purchasing availability or individual suitability." }, "source": { "id": "src_f4553a4ff5a41d73", "label": "DailyMed（NLM）：ONGLYZA 2.5 mg／5 mg 美国有日期包装面板（AstraZeneca；2025-12 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=c5116390-e0fe-4969-94cb-e9de5165fbab&type=display", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-31", "reviewedAt": "2026-08-31" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "ONGLYZA 说明书放大阅读：胰腺、心衰、肾功能和重复降糖成分", "en": "ONGLYZA enlarged label: pancreas, heart failure, kidney function and duplicate glucose-lowering ingredients" }, "summary": { "zh": "严重且持续的腹痛、气短或平卧呼吸困难、脚踝水肿、体重快速增加、严重过敏或起水疱脱皮都需要及时联系医疗团队。网页不根据血糖、肾功能或症状替个人改变规格。", "en": "Severe persistent abdominal pain, shortness of breath or orthopnoea, ankle swelling, rapid weight gain, serious allergy, blistering or skin erosion requires timely clinical contact. The site does not change an individual's strength from glucose, kidney function or symptoms." }, "checks": [ { "zh": "2.5 mg 和 5 mg 是每片含量，不是每次片数。肾功能和强 CYP3A4/5 抑制剂可能影响专业用药决策，但网页不把检查值或药名自动换成规格。", "en": "2.5 mg and 5 mg are amounts per tablet, not tablet counts. Kidney function and strong CYP3A4/5 inhibitors may affect professional decisions, but the site does not convert test results or medicine names into a strength." }, { "zh": "严重、持续、可能向背部放射的腹痛，伴或不伴呕吐，可能提示胰腺炎，应按标签及时联系医疗团队。", "en": "Severe persistent abdominal pain that may radiate to the back, with or without vomiting, may signal pancreatitis and needs timely clinical contact as directed by the label." }, { "zh": "气短、平卧呼吸困难、脚踝或小腿水肿、体重异常快速增加或异常乏力可能提示心力衰竭，尤其既往心衰或肾脏问题者应优先核对。", "en": "Shortness of breath, orthopnoea, ankle or leg swelling, unusually rapid weight gain or unusual fatigue may signal heart failure, especially with prior heart failure or kidney problems." }, { "zh": "ONGLYZA、KOMBIGLYZE XR、QTERN 与 QTERNMET XR 可能共享沙格列汀；不要只按商品名叠加。与胰岛素或磺脲类同用时低血糖风险可能增加。", "en": "ONGLYZA, KOMBIGLYZE XR, QTERN and QTERNMET XR may share saxagliptin; do not combine from brand names. Hypoglycaemia risk may rise with insulin or a sulfonylurea." }, { "zh": "标签明确不得掰开或切开 ONGLYZA 片。刻印用于核对外观，不是自行减半许可。", "en": "The label says not to split or cut ONGLYZA tablets. Markings identify appearance and are not permission to halve a tablet." } ], "source": { "id": "src_0b60e28c45aabbe8", "label": "DailyMed（NLM）：ONGLYZA FDA 批准患者用药指南（2024-10 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/medguide.cfm?setid=e4f2a84f-5117-4738-b769-aba8debbddb0", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "patient_medication_guide", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-31", "reviewedAt": "2026-08-31" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "沙格列汀怎样起作用：抑制 DPP-4，延长餐后肠促胰素信号", "en": "How saxagliptin works: DPP-4 inhibition prolongs post-meal incretin signalling" }, "summary": { "zh": "标签说明 DPP-4 会快速灭活 GLP-1 与 GIP；抑制 DPP-4 可提高活性肠促胰素水平，在血糖依赖条件下促进胰岛素并降低胰高血糖素。这个机制不能替个人解释血糖波动或决定联合方案。", "en": "The label explains that DPP-4 rapidly inactivates GLP-1 and GIP. DPP-4 inhibition increases active incretin levels, supporting glucose-dependent insulin release and lower glucagon. This does not interpret an individual's glucose variation or choose a combination." }, "checks": [ { "zh": "“血糖依赖”不等于绝不会低血糖；与胰岛素或磺脲类同时使用时仍需按标签核对风险。", "en": "Glucose-dependent does not mean hypoglycaemia is impossible; co-use with insulin or a sulfonylurea still requires labelled risk review." }, { "zh": "沙格列汀不是西格列汀或利格列汀，DPP-4 同类关系不能建立按毫克换算、轮换或叠加。", "en": "Saxagliptin is not sitagliptin or linagliptin; a shared DPP-4 class does not permit milligram conversion, rotation or combination." }, { "zh": "ONGLYZA 不是胰岛素，也不治疗 1 型糖尿病或糖尿病酮症酸中毒；网页不会依据一次血糖读数推荐药物。", "en": "ONGLYZA is not insulin and does not treat type 1 diabetes or diabetic ketoacidosis; the site does not recommend a medicine from one glucose reading." } ], "source": { "id": "src_27a0faac544cec60", "label": "DailyMed（NLM）：ONGLYZA 沙格列汀 2.5 mg／5 mg 美国公开处方标签档案", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=e4f2a84f-5117-4738-b769-aba8debbddb0", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-31", "reviewedAt": "2026-08-31" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "ONGLYZA", "generic": "沙格列汀", "dosageFormClass": "薄膜衣口服片：每片相当于沙格列汀 2.5 mg 或 5 mg。标签明确不得掰开或切开；两个规格不是网页替个人选择或换算的方案。" }, "labelSource": { "id": "src_27a0faac544cec60", "label": "DailyMed（NLM）：ONGLYZA 沙格列汀 2.5 mg／5 mg 美国公开处方标签档案", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=e4f2a84f-5117-4738-b769-aba8debbddb0", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-31", "reviewedAt": "2026-08-31" }, "productRoutes": [ { "source": { "id": "src_27a0faac544cec60", "label": "DailyMed（NLM）：ONGLYZA 沙格列汀 2.5 mg／5 mg 美国公开处方标签档案", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=e4f2a84f-5117-4738-b769-aba8debbddb0", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-31", "reviewedAt": "2026-08-31" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-31", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_f4553a4ff5a41d73", "label": "DailyMed（NLM）：ONGLYZA 2.5 mg／5 mg 美国有日期包装面板（AstraZeneca；2025-12 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=c5116390-e0fe-4969-94cb-e9de5165fbab&type=display", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-31", "reviewedAt": "2026-08-31" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-31", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_10e511bf83430e3b", "label": "FDA Orange Book：ONGLYZA／saxagliptin NDA 022350 的 2.5 mg 与 5 mg 历史 RLD 记录", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-08-29", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-31", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "ONGLYZA 是沙格列汀品牌档案。普通人优先看三件事：持续剧烈上腹痛可能涉及胰腺炎；气短、平卧呼吸困难、脚踝水肿或体重快速增加可能涉及心力衰竭；与胰岛素或磺脲类同用时低血糖风险可能增加。", "history": "美国 NDA 022350 于 2009-07-31 批准 2.5 mg 与 5 mg 片，当前 Orange Book 品牌行均为 DISCN。加拿大 DPD 当前将 DIN 02333554（5 mg）与 DIN 02375842（2.5 mg）列为 Marketed。", "sourceDocuments": [ { "id": "src_0b60e28c45aabbe8", "label": "DailyMed（NLM）：ONGLYZA FDA 批准患者用药指南（2024-10 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/medguide.cfm?setid=e4f2a84f-5117-4738-b769-aba8debbddb0", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "patient_medication_guide", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-31", "reviewedAt": "2026-08-31" }, { "id": "src_27a0faac544cec60", "label": "DailyMed（NLM）：ONGLYZA 沙格列汀 2.5 mg／5 mg 美国公开处方标签档案", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=e4f2a84f-5117-4738-b769-aba8debbddb0", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-31", "reviewedAt": "2026-08-31" }, { "id": "src_f4553a4ff5a41d73", "label": "DailyMed（NLM）：ONGLYZA 2.5 mg／5 mg 美国有日期包装面板（AstraZeneca；2025-12 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=c5116390-e0fe-4969-94cb-e9de5165fbab&type=display", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-31", "reviewedAt": "2026-08-31" }, { "id": "src_f569b57eee87a182", "label": "Health Canada：药品产品数据库（DPD）当前访问页；在库内核对 ONGLYZA 2.5 mg／5 mg", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_lookup_entry", "documentKind": "regulatory_lookup", "market": "CA", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-09-13", "reviewedAt": "2026-09-13" }, { "id": "src_10e511bf83430e3b", "label": "FDA Orange Book：ONGLYZA／saxagliptin NDA 022350 的 2.5 mg 与 5 mg 历史 RLD 记录", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } ], "applicationNumber": "美国历史 NDA 022350；加拿大 DIN 02375842 / 02333554", "approvalTimeline": [ { "date": "2009-07-31", "title": { "zh": "美国 ONGLYZA 2.5 mg 与 5 mg 初始批准", "en": "Initial U.S. approval of ONGLYZA 2.5 mg and 5 mg" }, "detail": { "zh": "Orange Book 记录 NDA 022350 两个历史 RLD 产品，当前均为 DISCN。", "en": "Orange Book records two historical RLD products under NDA 022350, both currently DISCN." }, "source": { "id": "src_10e511bf83430e3b", "label": "FDA Orange Book：ONGLYZA／saxagliptin NDA 022350 的 2.5 mg 与 5 mg 历史 RLD 记录", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } }, { "date": "2024-10-08", "title": { "zh": "美国患者用药指南修订", "en": "U.S. Medication Guide revised" }, "detail": { "zh": "指南强化胰腺炎、心力衰竭、低血糖、严重关节痛和大疱性类天疱疮等普通人可识别信号。", "en": "The guide highlights patient-recognisable signals involving pancreatitis, heart failure, hypoglycaemia, severe joint pain and bullous pemphigoid." }, "source": { "id": "src_0b60e28c45aabbe8", "label": "DailyMed（NLM）：ONGLYZA FDA 批准患者用药指南（2024-10 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/medguide.cfm?setid=e4f2a84f-5117-4738-b769-aba8debbddb0", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "patient_medication_guide", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-31", "reviewedAt": "2026-08-31" } }, { "date": "2026-07-29", "title": { "zh": "加拿大当前 Marketed 数据更新", "en": "Current Canadian Marketed data updated" }, "detail": { "zh": "DPD 保留 ONGLYZA 2.5 mg 与 5 mg 两个 Marketed DIN。", "en": "DPD retains Marketed DIN records for ONGLYZA 2.5 mg and 5 mg." }, "source": { "id": "src_f569b57eee87a182", "label": "Health Canada：药品产品数据库（DPD）当前访问页；在库内核对 ONGLYZA 2.5 mg／5 mg", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_lookup_entry", "documentKind": "regulatory_lookup", "market": "CA", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-09-13", "reviewedAt": "2026-09-13" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "历史 RLD，当前 DISCN", "en": "Historical RLD; currently DISCN" }, "detail": { "zh": "公开标签可阅读，但不证明当前品牌库存。", "en": "The public label remains readable but does not establish current brand stock." } }, { "market": { "zh": "加拿大", "en": "Canada" }, "status": { "zh": "2.5 mg 与 5 mg 均为 Marketed", "en": "2.5 mg and 5 mg both Marketed" }, "detail": { "zh": "分别对应 DIN 02375842 与 02333554；实际供应仍需当地核对。", "en": "DIN 02375842 and 02333554 respectively; actual supply still requires local checking." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "5 mg 可以掰半当 2.5 mg 吗？", "en": "Can a 5 mg tablet be halved to make 2.5 mg?" }, "answer": { "zh": "不能自行这样做。患者指南明确写明不得掰开或切开；2.5 mg 是独立规格，个人选择必须由开方团队按准确产品与肾功能等信息决定。", "en": "Do not decide this yourself. The Medication Guide says not to split or cut the tablet. The 2.5 mg product is a separate strength, and individual selection requires the prescriber to review the exact product and factors such as kidney function." } }, { "question": { "zh": "复方药里已经有沙格列汀，还能加 ONGLYZA 吗？", "en": "Can ONGLYZA be added if a combination product already contains saxagliptin?" }, "answer": { "zh": "不要自行叠加。先核对 KOMBIGLYZE XR、QTERN 或 QTERNMET XR 的全部有效成分，并让药师检查是否重复。", "en": "Do not self-add it. Check every active ingredient in KOMBIGLYZE XR, QTERN or QTERNMET XR and have a pharmacist assess duplication." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "dose-unit-literacy", "same-class-is-not-same-medicine" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/onglyza-saxagliptin/", "en": "https://origindrug.com/en/drugs/onglyza-saxagliptin/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "prandin-novonorm-repaglinide", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-31", "status": "published_traceable_archive" }, "names": { "brand": "NovoNorm / PRANDIN", "generic": "瑞格列奈", "aliases": [ "NovoNorm", "PRANDIN", "Prandin", "repaglinide", "瑞格列奈", "瑞格列奈片", "诺和龙", "repaglinide tablets", "NDA 020741", "EMEA/H/C/000187", "EMEA/H/C/000362" ], "marketBrandNames": [ { "name": "NovoNorm", "market": { "zh": "EU", "en": "EU" }, "note": null, "source": { "id": "src_05bf258a552c35fe", "label": "EMA：NovoNorm 瑞格列奈 EPAR 授权记录", "url": "https://www.ema.europa.eu/en/medicines/human/EPAR/novonorm", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-31", "reviewedAt": "2026-08-31" } }, { "name": "Prandin", "market": { "zh": "EU", "en": "EU" }, "note": null, "source": { "id": "src_ee2a949c77b2dc48", "label": "EMA：Prandin 瑞格列奈 EPAR 授权记录", "url": "https://www.ema.europa.eu/en/medicines/human/EPAR/prandin", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-31", "reviewedAt": "2026-08-31" } }, { "name": "PRANDIN", "market": { "zh": "US", "en": "US" }, "note": null, "source": { "id": "src_10e511bf83430e3b", "label": "FDA Orange Book：PRANDIN／repaglinide NDA 020741 历史 RLD 记录", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } }, { "name": "NovoNorm", "market": { "zh": "CN", "en": "CN" }, "note": null, "source": { "id": "src_6886ccd150c2c1fd", "label": "济宁市人民政府：2026 年公开药品价格页中的诺和龙／瑞格列奈片名称与规格线索", "url": "https://dlrk.jining.gov.cn/art/2026/4/28/art_91842_2879444.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "government_price_record", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-31", "reviewedAt": "2026-08-31" } } ], "mainlandChinaTradeNameCue": { "value": "诺和龙®", "status": "discovery_cue_requires_target_market_verification", "source": { "id": "src_281bcdb5add33c39", "label": "泾县人民政府：医保高值药品参考清单中的诺和龙／瑞格列奈片记录", "url": "https://www.ahxx.gov.cn/group1/M00/47/45/Cpc8VmZo5wiAK4pvAAM6bEblTyM892.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "government_medicine_listing", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-12", "reviewedAt": "2026-09-12" } } }, "identity": { "therapeuticArea": "代谢", "sourceArchiveMarket": "欧盟 EMA 当前将 NovoNorm（EMEA/H/C/000187）与 Prandin（EMEA/H/C/000362）列为授权产品；美国 FDA Orange Book 的 PRANDIN 0.5、1、2 mg 为 NDA 020741 历史 RLD、当前均为 DISCN，且公开记录显示并非因安全性或有效性撤回；中国政府 2026 年公开页面仅用于证明“诺和龙／瑞格列奈片”的有日期名称与规格线索，不替代 NMPA 当前批准、实时库存或真伪核验。", "dosageFormClass": "口服片：0.5 mg、1 mg、2 mg 均为每片瑞格列奈含量；这些数字不是每次片数。EMA 说明书列出 30、90、120 或 270 片铝/铝泡罩包装，并注明并非所有包装规格都会上市；网页不把包装数量变成个人用法。", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "1997（美国初始批准）／1998（欧盟 NovoNorm 首次授权）", "archiveSponsorText": "Novo Nordisk（欧盟授权记录与美国历史原研参比记录）" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [ "NovoNorm repaglinide", "PRANDIN repaglinide", "瑞格列奈", "瑞格列奈片", "诺和龙" ], "excludedProductCues": [ "PRANDIMET", "repaglinide and metformin", "瑞格列奈二甲双胍", "STARLIX", "nateglinide", "那格列奈" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "eu-novonorm-repaglinide-0-5mg-tablet", "marketCode": "EU", "labelVersion": { "zh": "EMA 当前公开产品说明书", "en": "Current public EMA product information" }, "dosageForm": { "zh": "NovoNorm 瑞格列奈 0.5 mg 口服片", "en": "NovoNorm repaglinide 0.5 mg oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "EMEA/H/C/000187", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片含瑞格列奈 0.5 mg；白色圆形凸面片，刻 Novo Nordisk 标志；不是个人每次片数", "en": "0.5 mg repaglinide per tablet; white round convex tablet engraved with the Novo Nordisk logo; not an individual's tablet count" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "瑞格列奈", "en": "repaglinide" }, "value": 0.5, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人频次或餐时方案", "en": "labelled amount per tablet; not an individual's frequency or meal schedule" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-31", "currentLabelDisplayed": true, "ndcDirectoryListed": false, "marketAvailability": "current_authorised_regulatory_record", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": null, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_26f15f0758888053", "label": "EMA：NovoNorm（瑞格列奈）欧盟产品说明书", "url": "https://www.ema.europa.eu/en/documents/product-information/novonorm-epar-product-information_en.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-31", "reviewedAt": "2026-08-31" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "eu-novonorm-repaglinide-1mg-tablet", "marketCode": "EU", "labelVersion": { "zh": "EMA 当前公开产品说明书", "en": "Current public EMA product information" }, "dosageForm": { "zh": "NovoNorm 瑞格列奈 1 mg 口服片", "en": "NovoNorm repaglinide 1 mg oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "EMEA/H/C/000187", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片含瑞格列奈 1 mg；黄色圆形凸面片，刻 Novo Nordisk 标志；不是个人每次片数", "en": "1 mg repaglinide per tablet; yellow round convex tablet engraved with the Novo Nordisk logo; not an individual's tablet count" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "瑞格列奈", "en": "repaglinide" }, "value": 1, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人频次或餐时方案", "en": "labelled amount per tablet; not an individual's frequency or meal schedule" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-31", "currentLabelDisplayed": true, "ndcDirectoryListed": false, "marketAvailability": "current_authorised_regulatory_record", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": null, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_26f15f0758888053", "label": "EMA：NovoNorm（瑞格列奈）欧盟产品说明书", "url": "https://www.ema.europa.eu/en/documents/product-information/novonorm-epar-product-information_en.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-31", "reviewedAt": "2026-08-31" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "eu-novonorm-repaglinide-2mg-tablet", "marketCode": "EU", "labelVersion": { "zh": "EMA 当前公开产品说明书", "en": "Current public EMA product information" }, "dosageForm": { "zh": "NovoNorm 瑞格列奈 2 mg 口服片", "en": "NovoNorm repaglinide 2 mg oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "EMEA/H/C/000187", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片含瑞格列奈 2 mg；桃色圆形凸面片，刻 Novo Nordisk 标志；不是个人每次片数", "en": "2 mg repaglinide per tablet; peach-coloured round convex tablet engraved with the Novo Nordisk logo; not an individual's tablet count" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "瑞格列奈", "en": "repaglinide" }, "value": 2, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人频次或餐时方案", "en": "labelled amount per tablet; not an individual's frequency or meal schedule" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-31", "currentLabelDisplayed": true, "ndcDirectoryListed": false, "marketAvailability": "current_authorised_regulatory_record", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": null, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_26f15f0758888053", "label": "EMA：NovoNorm（瑞格列奈）欧盟产品说明书", "url": "https://www.ema.europa.eu/en/documents/product-information/novonorm-epar-product-information_en.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-31", "reviewedAt": "2026-08-31" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-prandin-repaglinide-0-5mg-product-001", "marketCode": "US", "labelVersion": { "zh": "FDA Orange Book 当前数据集中的历史品牌记录", "en": "Historical brand record in the current FDA Orange Book dataset" }, "dosageForm": { "zh": "PRANDIN 瑞格列奈 0.5 mg 口服片", "en": "PRANDIN repaglinide 0.5 mg oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDA 020741 / Product 001", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片瑞格列奈 0.5 mg；历史 RLD，当前 DISCN", "en": "0.5 mg repaglinide per tablet; historical RLD, currently DISCN" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "瑞格列奈", "en": "repaglinide" }, "value": 0.5, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片历史产品标示量；不证明当前品牌库存", "en": "amount per historical product tablet; does not establish current brand stock" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-31", "currentLabelDisplayed": false, "ndcDirectoryListed": false, "marketAvailability": "historical_discontinued_rld", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": null, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_10e511bf83430e3b", "label": "FDA Orange Book：PRANDIN／repaglinide NDA 020741 历史 RLD 记录", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-prandin-repaglinide-1mg-product-002", "marketCode": "US", "labelVersion": { "zh": "FDA Orange Book 当前数据集中的历史品牌记录", "en": "Historical brand record in the current FDA Orange Book dataset" }, "dosageForm": { "zh": "PRANDIN 瑞格列奈 1 mg 口服片", "en": "PRANDIN repaglinide 1 mg oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDA 020741 / Product 002", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片瑞格列奈 1 mg；历史 RLD，当前 DISCN", "en": "1 mg repaglinide per tablet; historical RLD, currently DISCN" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "瑞格列奈", "en": "repaglinide" }, "value": 1, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片历史产品标示量；不证明当前品牌库存", "en": "amount per historical product tablet; does not establish current brand stock" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-31", "currentLabelDisplayed": false, "ndcDirectoryListed": false, "marketAvailability": "historical_discontinued_rld", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": null, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_10e511bf83430e3b", "label": "FDA Orange Book：PRANDIN／repaglinide NDA 020741 历史 RLD 记录", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-prandin-repaglinide-2mg-product-003", "marketCode": "US", "labelVersion": { "zh": "FDA Orange Book 当前数据集中的历史品牌记录", "en": "Historical brand record in the current FDA Orange Book dataset" }, "dosageForm": { "zh": "PRANDIN 瑞格列奈 2 mg 口服片", "en": "PRANDIN repaglinide 2 mg oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDA 020741 / Product 003", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片瑞格列奈 2 mg；历史 RLD，当前 DISCN", "en": "2 mg repaglinide per tablet; historical RLD, currently DISCN" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "瑞格列奈", "en": "repaglinide" }, "value": 2, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片历史产品标示量；不证明当前品牌库存", "en": "amount per historical product tablet; does not establish current brand stock" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-31", "currentLabelDisplayed": false, "ndcDirectoryListed": false, "marketAvailability": "historical_discontinued_rld", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": null, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_10e511bf83430e3b", "label": "FDA Orange Book：PRANDIN／repaglinide NDA 020741 历史 RLD 记录", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "status": "withheld_repackaged_or_non_exact_visual", "title": { "zh": "有官方片剂外观文字，但未取得六个身份逐一对应的当前官方包装主图", "en": "Official tablet appearance text is available, but no current official principal pack image was obtained one-to-one for all six identities" }, "summary": { "zh": "EMA 说明书描述 0.5 mg 为白色、1 mg 为黄色、2 mg 为桃色的圆形凸面片，并刻 Novo Nordisk 标志。颜色和标志只能作为欧盟准确产品的辅助线索；美国历史 PRANDIN、中国诺和龙以及不同批次包装可能不同，不能据此单独判断真伪。", "en": "The EMA label describes round convex tablets engraved with the Novo Nordisk logo: white for 0.5 mg, yellow for 1 mg and peach-coloured for 2 mg. Colour and logo are supporting clues only for the exact EU product. Historical U.S. PRANDIN, China-market NovoNorm and packs from other periods may differ, so appearance alone cannot establish authenticity." }, "source": { "id": "src_26f15f0758888053", "label": "EMA：NovoNorm（瑞格列奈）欧盟产品说明书", "url": "https://www.ema.europa.eu/en/documents/product-information/novonorm-epar-product-information_en.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-31", "reviewedAt": "2026-08-31" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "NovoNorm 说明书放大阅读：每片含量、餐时语言、低血糖与相互作用", "en": "NovoNorm enlarged label: per-tablet strength, meal-related wording, hypoglycaemia and interactions" }, "summary": { "zh": "说明书把瑞格列奈与正餐相联系，但本站不生成个人几点服、漏餐怎么办或补不补服的时间表。请按自己药盒、处方和当前说明书向开方者或药师核对；若出现意识混乱、抽搐、昏迷或严重低血糖疑虑，应立即寻求当地急救。", "en": "The label links repaglinide to main meals, but this site does not generate an individual clock time, missed-meal rule or make-up instruction. Check the exact pack, prescription and current label with the prescriber or pharmacist. Confusion, seizure, unconsciousness or concern about severe hypoglycaemia requires immediate local emergency help." }, "checks": [ { "zh": "0.5 mg、1 mg、2 mg 是每片含量，不是每餐片数；不同规格、不同市场和不同包装不能只按数字自行拼片或互换。", "en": "0.5 mg, 1 mg and 2 mg are amounts per tablet, not tablets per meal. Different strengths, markets and packs must not be assembled or interchanged from numbers alone." }, { "zh": "说明书有餐前和漏餐相关文字，但个人餐次、血糖、处方和合并药不同。网页只提示核对，不自动生成餐时或漏服方案。", "en": "The label contains pre-meal and missed-meal wording, but meal patterns, glucose, prescriptions and co-medications differ. The site prompts verification and does not generate a meal-time or missed-dose plan." }, { "zh": "瑞格列奈可导致低血糖；出汗、发抖、头晕、头痛或行为意识改变应及时按个人既有专业应急计划处理并联系医疗团队。抽搐、意识丧失或昏迷立即求助当地急救。", "en": "Repaglinide can cause hypoglycaemia. Sweating, tremor, dizziness, headache or behavioural or awareness change requires prompt action under the individual's established professional emergency plan and clinical contact. Seizure, loss of consciousness or coma requires immediate local emergency help." }, { "zh": "吉非贝齐与瑞格列奈合用属于说明书禁忌。氯吡格雷可能显著增加瑞格列奈暴露；二甲双胍或其他降糖药可增加低血糖风险；β 受体阻滞剂可能掩盖低血糖信号。请带完整药单核对，不要自行停换或错开。", "en": "Gemfibrozil co-use is contraindicated by the label. Clopidogrel may substantially increase repaglinide exposure; metformin or another glucose-lowering medicine can increase hypoglycaemia risk; beta blockers may mask hypoglycaemia signals. Review the full medicine list and do not self-stop, switch or separate medicines." }, { "zh": "严重肝功能障碍属于禁忌；体弱、营养不足、肝肾问题以及 75 岁以上人群需要专业核对。说明书指出 75 岁以上未开展临床研究，网页不会把年龄自动换成规格。", "en": "Severe hepatic dysfunction is contraindicated. Frailty, malnutrition, liver or kidney problems and age over 75 require professional review. The label says no clinical studies were conducted above age 75; the site does not convert age into a strength." }, { "zh": "PRANDIMET 同时含瑞格列奈和二甲双胍，是不同复方产品；不能把它与单方 NovoNorm／PRANDIN 按商品名叠加。", "en": "PRANDIMET contains both repaglinide and metformin and is a different combination product. It must not be combined with single-ingredient NovoNorm or PRANDIN by brand name." } ], "source": { "id": "src_26f15f0758888053", "label": "EMA：NovoNorm（瑞格列奈）欧盟产品说明书", "url": "https://www.ema.europa.eu/en/documents/product-information/novonorm-epar-product-information_en.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-31", "reviewedAt": "2026-08-31" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "瑞格列奈怎样起作用：短效促胰岛素分泌，不等于胰岛素本身", "en": "How repaglinide works: a short-acting insulin secretagogue, not insulin itself" }, "summary": { "zh": "EMA 说明书称瑞格列奈通过关闭胰岛 β 细胞膜上的 ATP 依赖性钾通道，使细胞去极化、钙通道开放并促进胰岛素释放；这一作用依赖仍有功能的 β 细胞。机制不能替个人解释一次血糖或决定联用、换药和规格。", "en": "The EMA label says repaglinide closes ATP-dependent potassium channels in pancreatic beta-cell membranes, depolarising the cells, opening calcium channels and stimulating insulin release. This depends on functioning beta cells. The mechanism cannot interpret one glucose result or choose a combination, switch or strength for an individual." }, "checks": [ { "zh": "瑞格列奈不是胰岛素，也不用于 1 型糖尿病或糖尿病酮症酸中毒。", "en": "Repaglinide is not insulin and is not for type 1 diabetes or diabetic ketoacidosis." }, { "zh": "瑞格列奈、磺脲类和那格列奈都可能促进胰岛素分泌，但作用位点、产品和证据不同；同类或相近机制不允许按 mg 自行换算、叠加或轮换。", "en": "Repaglinide, sulfonylureas and nateglinide may all promote insulin release, but their targets, products and evidence differ. A related class or mechanism does not permit self-conversion, combination or rotation by milligrams." }, { "zh": "说明书描述 CYP2C8、CYP3A4 与 OATP1B1 相关相互作用，不表示普通人需要全基因组检测，也不能由网页从基因或药名自动计算方案。", "en": "The label describes interactions involving CYP2C8, CYP3A4 and OATP1B1. This does not mean everyone needs whole-genome testing, and the site does not calculate a plan from genes or medicine names." } ], "source": { "id": "src_26f15f0758888053", "label": "EMA：NovoNorm（瑞格列奈）欧盟产品说明书", "url": "https://www.ema.europa.eu/en/documents/product-information/novonorm-epar-product-information_en.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-31", "reviewedAt": "2026-08-31" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "NovoNorm / PRANDIN", "generic": "瑞格列奈", "dosageFormClass": "口服片：0.5 mg、1 mg、2 mg 均为每片瑞格列奈含量；这些数字不是每次片数。EMA 说明书列出 30、90、120 或 270 片铝/铝泡罩包装，并注明并非所有包装规格都会上市；网页不把包装数量变成个人用法。" }, "labelSource": { "id": "src_26f15f0758888053", "label": "EMA：NovoNorm（瑞格列奈）欧盟产品说明书", "url": "https://www.ema.europa.eu/en/documents/product-information/novonorm-epar-product-information_en.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-31", "reviewedAt": "2026-08-31" }, "productRoutes": [ { "source": { "id": "src_26f15f0758888053", "label": "EMA：NovoNorm（瑞格列奈）欧盟产品说明书", "url": "https://www.ema.europa.eu/en/documents/product-information/novonorm-epar-product-information_en.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-31", "reviewedAt": "2026-08-31" }, "status": "product_level_public_record_verified", "authority": { "zh": "EMA", "en": "EMA" }, "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "recordType": { "zh": "监管产品记录或欧盟产品资料", "en": "Regulatory product record or EU product information" }, "reviewedAt": "2026-08-31", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_05bf258a552c35fe", "label": "EMA：NovoNorm 瑞格列奈 EPAR 授权记录", "url": "https://www.ema.europa.eu/en/medicines/human/EPAR/novonorm", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-31", "reviewedAt": "2026-08-31" }, "status": "product_level_public_record_verified", "authority": { "zh": "EMA", "en": "EMA" }, "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "recordType": { "zh": "监管产品记录或欧盟产品资料", "en": "Regulatory product record or EU product information" }, "reviewedAt": "2026-08-31", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_ee2a949c77b2dc48", "label": "EMA：Prandin 瑞格列奈 EPAR 授权记录", "url": "https://www.ema.europa.eu/en/medicines/human/EPAR/prandin", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-31", "reviewedAt": "2026-08-31" }, "status": "product_level_public_record_verified", "authority": { "zh": "EMA", "en": "EMA" }, "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "recordType": { "zh": "监管产品记录或欧盟产品资料", "en": "Regulatory product record or EU product information" }, "reviewedAt": "2026-08-31", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_10e511bf83430e3b", "label": "FDA Orange Book：PRANDIN／repaglinide NDA 020741 历史 RLD 记录", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-08-29", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "EMA", "en": "EMA" }, "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "recordType": { "zh": "监管产品记录或欧盟产品资料", "en": "Regulatory product record or EU product information" }, "reviewedAt": "2026-08-31", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "NovoNorm／PRANDIN 是瑞格列奈品牌档案。0.5、1、2 mg 是每片含量，不是个人餐次或片数；说明书把使用与进餐相联系，但网页不会据此生成个人餐时表。低血糖、吉非贝齐禁忌，以及氯吡格雷、其他降糖药和可能掩盖低血糖信号的 β 受体阻滞剂，是优先核对事项。", "history": "FDA 于 1997-12-22 批准 PRANDIN NDA 020741；EMA 产品说明书记录 NovoNorm 于 1998-08-17 首次授权，EMA 数据另记录 Prandin 于 2001-01-29 获得授权。三个美国品牌规格当前均为 DISCN；欧盟两项授权记录与美国历史记录必须分开阅读。", "sourceDocuments": [ { "id": "src_26f15f0758888053", "label": "EMA：NovoNorm（瑞格列奈）欧盟产品说明书", "url": "https://www.ema.europa.eu/en/documents/product-information/novonorm-epar-product-information_en.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-31", "reviewedAt": "2026-08-31" }, { "id": "src_05bf258a552c35fe", "label": "EMA：NovoNorm 瑞格列奈 EPAR 授权记录", "url": "https://www.ema.europa.eu/en/medicines/human/EPAR/novonorm", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-31", "reviewedAt": "2026-08-31" }, { "id": "src_ee2a949c77b2dc48", "label": "EMA：Prandin 瑞格列奈 EPAR 授权记录", "url": "https://www.ema.europa.eu/en/medicines/human/EPAR/prandin", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-31", "reviewedAt": "2026-08-31" }, { "id": "src_10e511bf83430e3b", "label": "FDA Orange Book：PRANDIN／repaglinide NDA 020741 历史 RLD 记录", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, { "id": "src_6886ccd150c2c1fd", "label": "济宁市人民政府：2026 年公开药品价格页中的诺和龙／瑞格列奈片名称与规格线索", "url": "https://dlrk.jining.gov.cn/art/2026/4/28/art_91842_2879444.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "government_price_record", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-31", "reviewedAt": "2026-08-31" } ], "applicationNumber": "欧盟 EMEA/H/C/000187（NovoNorm）、EMEA/H/C/000362（Prandin）；美国 NDA 020741（历史 PRANDIN）", "approvalTimeline": [ { "date": "1997-12-22", "title": { "zh": "美国 PRANDIN 初始批准", "en": "Initial U.S. approval of PRANDIN" }, "detail": { "zh": "FDA Orange Book 收录 NDA 020741 的 0.5、1、2 mg 历史 RLD 产品；当前均为 DISCN。", "en": "The FDA Orange Book records historical 0.5, 1 and 2 mg RLD products under NDA 020741; all are currently DISCN." }, "source": { "id": "src_10e511bf83430e3b", "label": "FDA Orange Book：PRANDIN／repaglinide NDA 020741 历史 RLD 记录", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } }, { "date": "1998-08-17", "title": { "zh": "欧盟 NovoNorm 首次授权", "en": "Initial EU authorisation of NovoNorm" }, "detail": { "zh": "EMA 产品说明书记录首次授权日期为 1998-08-17。", "en": "EMA product information records the initial authorisation date as 17 August 1998." }, "source": { "id": "src_26f15f0758888053", "label": "EMA：NovoNorm（瑞格列奈）欧盟产品说明书", "url": "https://www.ema.europa.eu/en/documents/product-information/novonorm-epar-product-information_en.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-31", "reviewedAt": "2026-08-31" } }, { "date": "2001-01-29", "title": { "zh": "欧盟 Prandin 获得授权", "en": "EU authorisation of Prandin" }, "detail": { "zh": "EMA 保留独立 Prandin EPAR 授权记录。", "en": "EMA retains a separate authorised Prandin EPAR record." }, "source": { "id": "src_ee2a949c77b2dc48", "label": "EMA：Prandin 瑞格列奈 EPAR 授权记录", "url": "https://www.ema.europa.eu/en/medicines/human/EPAR/prandin", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-31", "reviewedAt": "2026-08-31" } }, { "date": "2026-04-28", "title": { "zh": "中国政府公开页出现诺和龙名称与规格线索", "en": "China government page shows a dated NovoNorm name and strength cue" }, "detail": { "zh": "该页面列有诺和龙／瑞格列奈片 1 mg×30 与 2 mg×30；仅作为有日期名称线索，不证明 NMPA 当前状态或库存。", "en": "The page lists NovoNorm/repaglinide tablets at 1 mg × 30 and 2 mg × 30. It is only a dated name cue and does not establish current NMPA status or stock." }, "source": { "id": "src_6886ccd150c2c1fd", "label": "济宁市人民政府：2026 年公开药品价格页中的诺和龙／瑞格列奈片名称与规格线索", "url": "https://dlrk.jining.gov.cn/art/2026/4/28/art_91842_2879444.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "government_price_record", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-31", "reviewedAt": "2026-08-31" } } ], "marketStatus": [ { "market": { "zh": "欧盟", "en": "European Union" }, "status": { "zh": "NovoNorm 与 Prandin 当前授权记录", "en": "Current authorised NovoNorm and Prandin records" }, "detail": { "zh": "EMA 当前公开两个非仿制 EPAR 产品记录；实际供应仍须按国家核对。", "en": "EMA publicly retains two non-generic EPAR product records; actual supply still requires country-specific checking." } }, { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "历史 RLD，当前 DISCN", "en": "Historical RLD; currently DISCN" }, "detail": { "zh": "0.5、1、2 mg 品牌行均已停止销售，公开记录称并非因安全性或有效性撤回；不证明当前品牌有货。", "en": "The 0.5, 1 and 2 mg brand rows are discontinued, with public records indicating no safety-or-effectiveness withdrawal; this does not establish current brand stock." } }, { "market": { "zh": "中国", "en": "China" }, "status": { "zh": "有日期政府公开名称线索", "en": "Dated government public-name cue" }, "detail": { "zh": "“诺和龙”名称可用于搜索和药盒核对起点；NMPA 批准文号、当前说明书、库存和真伪仍需官方渠道逐项核验。", "en": "The NovoNorm name can start search and pack checking. NMPA approval number, current label, stock and authenticity still require item-by-item official verification." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "两片 0.5 mg 能自行换成一片 1 mg 吗？", "en": "Can two 0.5 mg tablets be self-replaced by one 1 mg tablet?" }, "answer": { "zh": "不能只做算术替换。虽然总标示量相同，准确产品、处方、包装、市场和个人计划仍需由药师或开方者核对。", "en": "Do not make an arithmetic substitution. Even when the labelled total matches, the exact product, prescription, pack, market and individual plan still require pharmacist or prescriber review." } }, { "question": { "zh": "没吃饭时网页能告诉我怎么处理吗？", "en": "Can the website tell me what to do if I do not eat?" }, "answer": { "zh": "不能生成个人指令。说明书把瑞格列奈与正餐相联系，但请按自己处方和当前药盒说明书联系药师或开方者；若已经服用后出现低血糖疑虑，及时按既有专业应急计划处理，严重症状立即求助当地急救。", "en": "The site cannot generate an individual instruction. The label links repaglinide to main meals, but use the exact prescription and current pack label and contact a pharmacist or prescriber. If it was already taken and hypoglycaemia is a concern, follow the established professional emergency plan promptly; severe symptoms require immediate local emergency help." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "dose-unit-literacy", "same-class-is-not-same-medicine", "how-to-read-a-drug-label" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/prandin-novonorm-repaglinide/", "en": "https://origindrug.com/en/drugs/prandin-novonorm-repaglinide/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "imdur-isosorbide-mononitrate", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-31", "status": "published_traceable_archive" }, "names": { "brand": "IMDUR", "generic": "单硝酸异山梨酯", "aliases": [ "Imdur", "isosorbide mononitrate", "isosorbide mononitrate extended release", "单硝酸异山梨酯", "单硝酸异山梨酯缓释片", "依姆多", "NDA 020225", "PL 46500/0002" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "心血管", "sourceArchiveMarket": "美国 FDA Orange Book：IMDUR 30 mg、60 mg、120 mg 均为 NDA 020225 历史 RLD、当前 DISCN，且并非因安全性或有效性撤回；英国 eMC：Imdur 60 mg 缓释片保留当前产品资料。英国产品说明不能自动替代美国历史标签或其他市场包装。", "dosageFormClass": "缓释口服片。英国准确 60 mg Durules 产品资料说明不得咀嚼或压碎、整片吞服，并另列该准确片可分割；这不能泛化为美国历史 30/60/120 mg 或其他厂牌均可掰片。", "dosageFormClassCode": "oral_modified_release", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "1987（英国首次授权）；1993（美国 30/60 mg）", "archiveSponsorText": "美国历史 NDA：Schering-Plough；英国当前产品资料：TopRidge Pharma" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [ "IMDUR", "Imdur isosorbide mononitrate", "单硝酸异山梨酯缓释片", "依姆多" ], "excludedProductCues": [ "MONOKET", "isosorbide mononitrate immediate release", "nitroglycerin", "glyceryl trinitrate", "硝酸甘油", "isosorbide dinitrate", "二硝酸异山梨酯" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-imdur-isosorbide-mononitrate-30mg-er-nda-020225-product-001", "marketCode": "US", "labelVersion": { "zh": "FDA Orange Book 当前数据中的历史产品身份（1993-08-12）", "en": "Historical product identity in the current FDA Orange Book dataset (1993-08-12)" }, "dosageForm": { "zh": "IMDUR 单硝酸异山梨酯 30 mg 口服缓释片（美国历史 RLD）", "en": "IMDUR isosorbide mononitrate 30 mg oral extended-release tablet (historical U.S. RLD)" }, "route": { "zh": "口服（历史监管产品身份字段）", "en": "oral (historical regulatory product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDA 020225 / Product 001", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片单硝酸异山梨酯 30 mg；历史 RLD 当前 DISCN", "en": "Isosorbide mononitrate 30 mg per tablet; historical RLD currently DISCN" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "单硝酸异山梨酯", "en": "isosorbide mononitrate" }, "value": 30, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片历史监管标示量；不是个人片数、频率或分片许可", "en": "historical regulatory amount per tablet; not an individual's tablet count, frequency or splitting permission" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-31", "currentLabelDisplayed": false, "ndcDirectoryListed": false, "marketAvailability": "historical_discontinued_rld", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": null, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_10e511bf83430e3b", "label": "FDA Orange Book：IMDUR／isosorbide mononitrate NDA 020225 的 30/60/120 mg 历史缓释片 RLD 记录", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-imdur-isosorbide-mononitrate-60mg-er-nda-020225-product-002", "marketCode": "US", "labelVersion": { "zh": "FDA Orange Book 当前数据中的历史产品身份（1993-08-12）", "en": "Historical product identity in the current FDA Orange Book dataset (1993-08-12)" }, "dosageForm": { "zh": "IMDUR 单硝酸异山梨酯 60 mg 口服缓释片（美国历史 RLD）", "en": "IMDUR isosorbide mononitrate 60 mg oral extended-release tablet (historical U.S. RLD)" }, "route": { "zh": "口服（历史监管产品身份字段）", "en": "oral (historical regulatory product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDA 020225 / Product 002", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片单硝酸异山梨酯 60 mg；历史 RLD 当前 DISCN", "en": "Isosorbide mononitrate 60 mg per tablet; historical RLD currently DISCN" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "单硝酸异山梨酯", "en": "isosorbide mononitrate" }, "value": 60, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片历史监管标示量；不是个人片数、频率或分片许可", "en": "historical regulatory amount per tablet; not an individual's tablet count, frequency or splitting permission" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-31", "currentLabelDisplayed": false, "ndcDirectoryListed": false, "marketAvailability": "historical_discontinued_rld", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": null, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_10e511bf83430e3b", "label": "FDA Orange Book：IMDUR／isosorbide mononitrate NDA 020225 的 30/60/120 mg 历史缓释片 RLD 记录", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-imdur-isosorbide-mononitrate-120mg-er-nda-020225-product-003", "marketCode": "US", "labelVersion": { "zh": "FDA Orange Book 当前数据中的历史产品身份（1995-03-30）", "en": "Historical product identity in the current FDA Orange Book dataset (1995-03-30)" }, "dosageForm": { "zh": "IMDUR 单硝酸异山梨酯 120 mg 口服缓释片（美国历史 RLD）", "en": "IMDUR isosorbide mononitrate 120 mg oral extended-release tablet (historical U.S. RLD)" }, "route": { "zh": "口服（历史监管产品身份字段）", "en": "oral (historical regulatory product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDA 020225 / Product 003", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片单硝酸异山梨酯 120 mg；历史 RLD 当前 DISCN", "en": "Isosorbide mononitrate 120 mg per tablet; historical RLD currently DISCN" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "单硝酸异山梨酯", "en": "isosorbide mononitrate" }, "value": 120, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片历史监管标示量；不是个人片数、频率或分片许可", "en": "historical regulatory amount per tablet; not an individual's tablet count, frequency or splitting permission" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-31", "currentLabelDisplayed": false, "ndcDirectoryListed": false, "marketAvailability": "historical_discontinued_rld", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": null, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_10e511bf83430e3b", "label": "FDA Orange Book：IMDUR／isosorbide mononitrate NDA 020225 的 30/60/120 mg 历史缓释片 RLD 记录", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "gb-imdur-isosorbide-mononitrate-60mg-durules-pl-46500-0002", "marketCode": "GB", "labelVersion": { "zh": "英国当前 eMC SmPC（2026-08-31 核验）", "en": "Current UK eMC SmPC (checked 31 Aug 2026)" }, "dosageForm": { "zh": "Imdur 单硝酸异山梨酯 60 mg 缓释薄膜衣片（Durules）", "en": "Imdur isosorbide mononitrate 60 mg extended-release film-coated tablet (Durules)" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "PL 46500/0002", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片单硝酸异山梨酯 60 mg；英国准确产品可分割但不得咀嚼或压碎", "en": "Isosorbide mononitrate 60 mg per tablet; this exact UK product is divisible but must not be chewed or crushed" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "单硝酸异山梨酯", "en": "isosorbide mononitrate" }, "value": 60, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片英国产品标示量；可分割声明只限该准确产品，不是个人方案", "en": "amount per UK product tablet; divisibility applies only to this exact product and is not an individual plan" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-31", "currentLabelDisplayed": true, "ndcDirectoryListed": false, "marketAvailability": "current_public_product_record", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": null, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_621dea5516084559", "label": "英国 eMC：Imdur 60 mg 缓释片当前 SmPC 产品资料", "url": "https://www.medicines.org.uk/emc/product/875/smpc", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_public_product_record", "documentKind": "product_label", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-31", "reviewedAt": "2026-08-31" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "status": "withheld_repackaged_or_non_exact_visual", "title": { "zh": "没有取得与四个产品身份一一对应的官方包装主图", "en": "No official principal pack image was obtained one-to-one for all four product identities" }, "summary": { "zh": "本页只展示官方文字身份，不以零售图、当前通用药、MONOKET 普通片、硝酸甘油或其他市场相似药片替代 IMDUR 包装。颜色、刻印、刻痕和能否分片必须按手中准确产品说明书核对。", "en": "Only official text identities are shown. Retail images, current generics, MONOKET immediate-release tablets, nitroglycerin and look-alike tablets from another market are not substituted for IMDUR packs. Colour, imprint, score and divisibility require the exact product label." }, "source": { "id": "src_621dea5516084559", "label": "英国 eMC：Imdur 60 mg 缓释片当前 SmPC 产品资料", "url": "https://www.medicines.org.uk/emc/product/875/smpc", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_public_product_record", "documentKind": "product_label", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-31", "reviewedAt": "2026-08-31" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "IMDUR 说明书放大阅读：缓释预防药不是急性胸痛急救药", "en": "IMDUR enlarged label: a preventive extended-release medicine is not acute chest-pain rescue" }, "summary": { "zh": "IMDUR 用于预防心绞痛，英国资料明确不用于缓解急性发作。急性胸痛应按既有急救计划和当地紧急医疗流程处理；网页不生成急救步骤或个人剂量。", "en": "IMDUR is used to prevent angina, and the UK information states it is not for relief of an acute attack. Acute chest pain requires the existing emergency plan and local urgent-care pathway; the site does not generate rescue steps or an individual dose." }, "checks": [ { "zh": "不要把 IMDUR 缓释片、MONOKET 普通片和舌下/颊用硝酸甘油按成分家族或毫克数自行换算、交替或替代。", "en": "Do not self-convert, alternate or substitute IMDUR extended-release tablets, MONOKET immediate-release tablets and sublingual/buccal nitroglycerin from a nitrate family or milligram figures." }, { "zh": "西地那非、他达拉非、伐地那非等 PDE-5 抑制剂与有机硝酸酯可能造成危险性低血压；不要自行错开时间来规避禁忌，应立即向开方团队核对完整药单。", "en": "PDE-5 inhibitors such as sildenafil, tadalafil or vardenafil with an organic nitrate may cause dangerous hypotension. Do not invent a separation interval to bypass the contraindication; promptly review the complete list with the prescriber." }, { "zh": "头晕、低血压或晕厥风险与降压药、利尿剂、其他血管扩张药和酒精同在药单时更需核对。老年人起身不稳或跌倒应及时评估。", "en": "Dizziness, hypotension or syncope requires priority review with antihypertensives, diuretics, other vasodilators or alcohol. Unsteadiness on standing or a fall in an older person needs timely assessment." }, { "zh": "英国准确 60 mg 产品说明可分割，但仍明确不得咀嚼或压碎；这不是所有 IMDUR、通用缓释片或其他市场产品的通用许可。", "en": "The exact UK 60 mg product is described as divisible but must not be chewed or crushed. This is not universal permission for every IMDUR, generic extended-release or other-market product." } ], "source": { "id": "src_621dea5516084559", "label": "英国 eMC：Imdur 60 mg 缓释片当前 SmPC 产品资料", "url": "https://www.medicines.org.uk/emc/product/875/smpc", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_public_product_record", "documentKind": "product_label", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-31", "reviewedAt": "2026-08-31" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "单硝酸异山梨酯怎样起作用：有机硝酸酯使血管平滑肌松弛", "en": "How isosorbide mononitrate works: an organic nitrate relaxes vascular smooth muscle" }, "summary": { "zh": "血管扩张可降低心脏负荷并帮助预防心绞痛，但也解释了头痛、头晕和低血压风险。缓释结构延长释放，不会把它变成急性发作时立即起效的急救药。", "en": "Vasodilation can reduce cardiac workload and help prevent angina, while also explaining headache, dizziness and hypotension. Extended release prolongs delivery and does not turn it into immediate rescue for an acute attack." }, "checks": [ { "zh": "缓释不是“药效更强”，而是释放过程不同；不能用普通片数量拼成缓释效果。", "en": "Extended release does not mean stronger; it means a different release process. Immediate-release tablet counts cannot be assembled to recreate it." }, { "zh": "同为硝酸酯不等于同一产品；给药途径、释放方式和临床情境必须一起核对。", "en": "Sharing a nitrate class does not make products identical; route, release design and clinical context must be checked together." }, { "zh": "头痛或头晕不能作为自行加量、减量、停药或换药依据。", "en": "Headache or dizziness is not a basis for self-increasing, reducing, stopping or switching treatment." } ], "source": { "id": "src_621dea5516084559", "label": "英国 eMC：Imdur 60 mg 缓释片当前 SmPC 产品资料", "url": "https://www.medicines.org.uk/emc/product/875/smpc", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_public_product_record", "documentKind": "product_label", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-31", "reviewedAt": "2026-08-31" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "IMDUR", "generic": "单硝酸异山梨酯", "dosageFormClass": "缓释口服片。英国准确 60 mg Durules 产品资料说明不得咀嚼或压碎、整片吞服，并另列该准确片可分割；这不能泛化为美国历史 30/60/120 mg 或其他厂牌均可掰片。" }, "labelSource": { "id": "src_621dea5516084559", "label": "英国 eMC：Imdur 60 mg 缓释片当前 SmPC 产品资料", "url": "https://www.medicines.org.uk/emc/product/875/smpc", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_public_product_record", "documentKind": "product_label", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-31", "reviewedAt": "2026-08-31" }, "productRoutes": [ { "source": { "id": "src_621dea5516084559", "label": "英国 eMC：Imdur 60 mg 缓释片当前 SmPC 产品资料", "url": "https://www.medicines.org.uk/emc/product/875/smpc", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_public_product_record", "documentKind": "product_label", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-31", "reviewedAt": "2026-08-31" }, "status": "product_level_public_record_verified", "authority": { "zh": "英国电子药品目录 eMC", "en": "UK electronic medicines compendium (emc)" }, "market": { "zh": "英国", "en": "United Kingdom" }, "recordType": { "zh": "公开药品说明书或患者说明书", "en": "Public product information or patient leaflet" }, "reviewedAt": "2026-08-31", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_10e511bf83430e3b", "label": "FDA Orange Book：IMDUR／isosorbide mononitrate NDA 020225 的 30/60/120 mg 历史缓释片 RLD 记录", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-08-29", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "英国电子药品目录 eMC", "en": "UK electronic medicines compendium (emc)" }, "market": { "zh": "英国", "en": "United Kingdom" }, "recordType": { "zh": "公开药品说明书或患者说明书", "en": "Public product information or patient leaflet" }, "reviewedAt": "2026-08-31", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "IMDUR 是单硝酸异山梨酯缓释品牌档案，用于预防心绞痛，不是急性胸痛时的急救药。胸痛突然发作、加重或伴呼吸困难、出汗、晕厥时，应使用当地紧急医疗流程；不要等待缓释片起效，也不要自行加量。", "history": "英国产品资料记录 1987-07-21 首次授权。美国 NDA 020225 的 30 mg 与 60 mg 于 1993-08-12 批准，120 mg 于 1995-03-30 批准；三个品牌行当前均为 DISCN。", "sourceDocuments": [ { "id": "src_621dea5516084559", "label": "英国 eMC：Imdur 60 mg 缓释片当前 SmPC 产品资料", "url": "https://www.medicines.org.uk/emc/product/875/smpc", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_public_product_record", "documentKind": "product_label", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-31", "reviewedAt": "2026-08-31" }, { "id": "src_10e511bf83430e3b", "label": "FDA Orange Book：IMDUR／isosorbide mononitrate NDA 020225 的 30/60/120 mg 历史缓释片 RLD 记录", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } ], "applicationNumber": "美国历史 NDA 020225；英国 PL 46500/0002", "approvalTimeline": [ { "date": "1987-07-21", "title": { "zh": "英国 Imdur 60 mg 首次授权", "en": "First UK authorisation of Imdur 60 mg" }, "detail": { "zh": "当前 SmPC 保留品牌、60 mg 缓释片与授权编号。", "en": "The current SmPC retains the brand, 60 mg extended-release tablet and authorisation number." }, "source": { "id": "src_621dea5516084559", "label": "英国 eMC：Imdur 60 mg 缓释片当前 SmPC 产品资料", "url": "https://www.medicines.org.uk/emc/product/875/smpc", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_public_product_record", "documentKind": "product_label", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-31", "reviewedAt": "2026-08-31" } }, { "date": "1993-08-12", "title": { "zh": "美国 30 mg 与 60 mg 历史 RLD 批准", "en": "Historical U.S. approval of 30 mg and 60 mg RLD products" }, "detail": { "zh": "两项均属 NDA 020225，当前 DISCN。", "en": "Both are under NDA 020225 and currently DISCN." }, "source": { "id": "src_10e511bf83430e3b", "label": "FDA Orange Book：IMDUR／isosorbide mononitrate NDA 020225 的 30/60/120 mg 历史缓释片 RLD 记录", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } }, { "date": "1995-03-30", "title": { "zh": "美国 120 mg 历史 RLD 批准", "en": "Historical U.S. approval of the 120 mg RLD product" }, "detail": { "zh": "当前同样列为 DISCN。", "en": "It is likewise currently listed DISCN." }, "source": { "id": "src_10e511bf83430e3b", "label": "FDA Orange Book：IMDUR／isosorbide mononitrate NDA 020225 的 30/60/120 mg 历史缓释片 RLD 记录", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "三个历史 RLD 均为 DISCN", "en": "All three historical RLD products are DISCN" }, "detail": { "zh": "并非因安全性或有效性撤回；不代表当前品牌供应。", "en": "Not withdrawn for safety or effectiveness reasons; does not establish current brand supply." } }, { "market": { "zh": "英国", "en": "United Kingdom" }, "status": { "zh": "60 mg 当前产品资料可读", "en": "Current 60 mg product information readable" }, "detail": { "zh": "PL 46500/0002；实际供应仍须当地核对。", "en": "PL 46500/0002; actual supply still requires local checking." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "胸痛时可以多吃一片 IMDUR 吗？", "en": "Can I take an extra IMDUR tablet during chest pain?" }, "answer": { "zh": "不要根据网页这样做。IMDUR 是预防用缓释药，不是急性发作急救药；突然或加重胸痛应按既有急救计划和当地紧急医疗流程处理。", "en": "Do not do this from a website. IMDUR is a preventive extended-release medicine, not acute rescue; sudden or worsening chest pain requires the existing emergency plan and local urgent-care pathway." } }, { "question": { "zh": "60 mg 有刻痕就都能掰半吗？", "en": "Does a score mean every 60 mg tablet can be halved?" }, "answer": { "zh": "不能泛化。英国准确 Imdur 60 mg 资料允许分割但不得咀嚼或压碎；其他厂牌和市场必须查手中准确说明书。", "en": "Do not generalise. The exact UK Imdur 60 mg information permits division but not chewing or crushing; every other manufacturer and market requires its exact label." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "dose-unit-literacy", "same-class-is-not-same-medicine" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/imdur-isosorbide-mononitrate/", "en": "https://origindrug.com/en/drugs/imdur-isosorbide-mononitrate/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "isordil-isosorbide-dinitrate", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-31", "status": "published_traceable_archive" }, "names": { "brand": "ISORDIL", "generic": "硝酸异山梨酯", "aliases": [ "Isordil", "Isordil Titradose", "isosorbide dinitrate", "硝酸异山梨酯", "硝酸异山梨酯片", "消心痛", "isosorbide dinitrate tablets", "NDA 012093", "NDC 0187-0152-01", "NDC 0187-0192-01" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "心血管", "sourceArchiveMarket": "美国 FDA Orange Book 当前将 ISORDIL NDA 012093 的 5 mg 与 40 mg 普通口服片列为处方 RLD，其中 40 mg 同时为 RS；10 mg、20 mg、30 mg 列为 DISCN，且并非因安全性或有效性撤回。DailyMed SPL v14 仍公开 5 mg 与 40 mg 的准确 100 片瓶装面板，但两个 NDC 的营销结束日期均已列出。监管 RLD/RX 身份、公开标签和历史包装均不证明实时库存或当前可获得性。", "dosageFormClass": "普通口服片，5/10/20/30/40 mg。ISORDIL 历史另有舌下片与缓释片 NDA，本档案不把那些途径或释放方式并入口服普通片，也不与 IMDUR、MONOKET、NITROSTAT 或 BiDil 换算。", "dosageFormClassCode": "oral_modified_release", "route": "口服普通片", "routeCode": "oral", "historicalApprovalEntry": "1988-07-29（FDA Orange Book 当前数据所列批准日期）", "archiveSponsorText": "Bausch Health US LLC（FDA 当前 NDA 012093 申请主体与 DailyMed 标签主体）" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [ "ISORDIL", "ISORDIL TITRADOSE", "Isordil isosorbide dinitrate", "硝酸异山梨酯片", "消心痛" ], "excludedProductCues": [ "IMDUR", "isosorbide mononitrate", "单硝酸异山梨酯", "MONOKET", "NITROSTAT", "nitroglycerin", "硝酸甘油", "BiDil", "hydralazine and isosorbide dinitrate", "ISORDIL sublingual", "ISORDIL extended release", "ISORDIL TEMBIDS" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-isordil-isosorbide-dinitrate-5mg-oral-tablet-nda-012093-product-007-ndc-0187015201", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v14（2026-02-06 生效）；包装营销结束 2025-08-31；Orange Book 当前产品类型 RX", "en": "DailyMed SPL v14 (effective 6 Feb 2026); package marketing ended 2025-08-31; current Orange Book product type RX" }, "dosageForm": { "zh": "ISORDIL 硝酸异山梨酯 5 mg 普通口服片", "en": "ISORDIL isosorbide dinitrate 5 mg immediate-release oral tablet" }, "route": { "zh": "口服普通片（不是舌下片或缓释片）", "en": "oral immediate-release tablet (not sublingual or extended release)" }, "routeCodes": [ "oral" ], "productCode": "NDA 012093 / Product 007 / NDC 0187-0152-01", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片硝酸异山梨酯 5 mg；Orange Book 当前处方 RLD", "en": "Isosorbide dinitrate 5 mg per tablet; current Orange Book prescription RLD" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=5-mg-label.jpg&archiveid=949353", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "硝酸异山梨酯", "en": "isosorbide dinitrate" }, "value": 5, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片监管或标签标示量；不是个人片数、频率、分片或与其他硝酸酯换算依据", "en": "regulatory or labelled amount per tablet; not an individual's tablet count, frequency, splitting instruction or conversion to another nitrate" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-31", "currentLabelDisplayed": true, "ndcDirectoryListed": false, "marketAvailability": "current_regulatory_rx_rld_package_marketing_ended", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "粉红色", "en": "pink" }, "shape": { "zh": "圆形、有深刻痕；刻痕只作外观核对，不是自行分片许可", "en": "round and deeply scored; the score is an appearance clue, not permission to self-split" }, "imprint": "BPI 152", "scoreStatus": "scored_status_not_a_split_instruction", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_9457a99656cefcba", "label": "DailyMed（NLM）：ISORDIL TITRADOSE 硝酸异山梨酯 5/40 mg 美国公开标签与两个准确包装面板（SPL v14；2026-02-06 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8ddd2577-311a-4967-bb67-ad72e2b76f83", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-31", "reviewedAt": "2026-08-31" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-isordil-isosorbide-dinitrate-10mg-oral-tablet-nda-012093-product-002-source-text", "marketCode": "US", "labelVersion": { "zh": "FDA Orange Book 当前监管产品身份；产品类型 DISCN", "en": "Current FDA Orange Book regulatory product identity; product type DISCN" }, "dosageForm": { "zh": "ISORDIL 硝酸异山梨酯 10 mg 普通口服片", "en": "ISORDIL isosorbide dinitrate 10 mg immediate-release oral tablet" }, "route": { "zh": "口服普通片（不是舌下片或缓释片）", "en": "oral immediate-release tablet (not sublingual or extended release)" }, "routeCodes": [ "oral" ], "productCode": "NDA 012093 / Product 002", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片硝酸异山梨酯 10 mg；历史 RLD 当前 DISCN", "en": "Isosorbide dinitrate 10 mg per tablet; historical RLD currently DISCN" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "硝酸异山梨酯", "en": "isosorbide dinitrate" }, "value": 10, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片监管或标签标示量；不是个人片数、频率、分片或与其他硝酸酯换算依据", "en": "regulatory or labelled amount per tablet; not an individual's tablet count, frequency, splitting instruction or conversion to another nitrate" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-31", "currentLabelDisplayed": false, "ndcDirectoryListed": false, "marketAvailability": "historical_discontinued_rld", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": null, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_10e511bf83430e3b", "label": "FDA Orange Book：ISORDIL 硝酸异山梨酯 NDA 012093 五个普通口服片 RLD 产品状态", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-isordil-isosorbide-dinitrate-20mg-oral-tablet-nda-012093-product-006-source-text", "marketCode": "US", "labelVersion": { "zh": "FDA Orange Book 当前监管产品身份；产品类型 DISCN", "en": "Current FDA Orange Book regulatory product identity; product type DISCN" }, "dosageForm": { "zh": "ISORDIL 硝酸异山梨酯 20 mg 普通口服片", "en": "ISORDIL isosorbide dinitrate 20 mg immediate-release oral tablet" }, "route": { "zh": "口服普通片（不是舌下片或缓释片）", "en": "oral immediate-release tablet (not sublingual or extended release)" }, "routeCodes": [ "oral" ], "productCode": "NDA 012093 / Product 006", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片硝酸异山梨酯 20 mg；历史 RLD 当前 DISCN", "en": "Isosorbide dinitrate 20 mg per tablet; historical RLD currently DISCN" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "硝酸异山梨酯", "en": "isosorbide dinitrate" }, "value": 20, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片监管或标签标示量；不是个人片数、频率、分片或与其他硝酸酯换算依据", "en": "regulatory or labelled amount per tablet; not an individual's tablet count, frequency, splitting instruction or conversion to another nitrate" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-31", "currentLabelDisplayed": false, "ndcDirectoryListed": false, "marketAvailability": "historical_discontinued_rld", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": null, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_10e511bf83430e3b", "label": "FDA Orange Book：ISORDIL 硝酸异山梨酯 NDA 012093 五个普通口服片 RLD 产品状态", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-isordil-isosorbide-dinitrate-30mg-oral-tablet-nda-012093-product-005-source-text", "marketCode": "US", "labelVersion": { "zh": "FDA Orange Book 当前监管产品身份；产品类型 DISCN", "en": "Current FDA Orange Book regulatory product identity; product type DISCN" }, "dosageForm": { "zh": "ISORDIL 硝酸异山梨酯 30 mg 普通口服片", "en": "ISORDIL isosorbide dinitrate 30 mg immediate-release oral tablet" }, "route": { "zh": "口服普通片（不是舌下片或缓释片）", "en": "oral immediate-release tablet (not sublingual or extended release)" }, "routeCodes": [ "oral" ], "productCode": "NDA 012093 / Product 005", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片硝酸异山梨酯 30 mg；历史 RLD 当前 DISCN", "en": "Isosorbide dinitrate 30 mg per tablet; historical RLD currently DISCN" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "硝酸异山梨酯", "en": "isosorbide dinitrate" }, "value": 30, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片监管或标签标示量；不是个人片数、频率、分片或与其他硝酸酯换算依据", "en": "regulatory or labelled amount per tablet; not an individual's tablet count, frequency, splitting instruction or conversion to another nitrate" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-31", "currentLabelDisplayed": false, "ndcDirectoryListed": false, "marketAvailability": "historical_discontinued_rld", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": null, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_10e511bf83430e3b", "label": "FDA Orange Book：ISORDIL 硝酸异山梨酯 NDA 012093 五个普通口服片 RLD 产品状态", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-isordil-isosorbide-dinitrate-40mg-oral-tablet-nda-012093-product-001-ndc-0187019201", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v14（2026-02-06 生效）；包装营销结束 2025-08-31；Orange Book 当前产品类型 RX", "en": "DailyMed SPL v14 (effective 6 Feb 2026); package marketing ended 2025-08-31; current Orange Book product type RX" }, "dosageForm": { "zh": "ISORDIL 硝酸异山梨酯 40 mg 普通口服片", "en": "ISORDIL isosorbide dinitrate 40 mg immediate-release oral tablet" }, "route": { "zh": "口服普通片（不是舌下片或缓释片）", "en": "oral immediate-release tablet (not sublingual or extended release)" }, "routeCodes": [ "oral" ], "productCode": "NDA 012093 / Product 001 / NDC 0187-0192-01", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片硝酸异山梨酯 40 mg；Orange Book 当前处方 RLD、同时为 RS", "en": "Isosorbide dinitrate 40 mg per tablet; current Orange Book prescription RLD and also RS" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=label%2040-mg.jpg&archiveid=949353", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "硝酸异山梨酯", "en": "isosorbide dinitrate" }, "value": 40, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片监管或标签标示量；不是个人片数、频率、分片或与其他硝酸酯换算依据", "en": "regulatory or labelled amount per tablet; not an individual's tablet count, frequency, splitting instruction or conversion to another nitrate" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-31", "currentLabelDisplayed": true, "ndcDirectoryListed": false, "marketAvailability": "current_regulatory_rx_rld_package_marketing_ended", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "浅绿色", "en": "light green" }, "shape": { "zh": "圆形、有深刻痕；刻痕只作外观核对，不是自行分片许可", "en": "round and deeply scored; the score is an appearance clue, not permission to self-split" }, "imprint": "BPI 192", "scoreStatus": "scored_status_not_a_split_instruction", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_9457a99656cefcba", "label": "DailyMed（NLM）：ISORDIL TITRADOSE 硝酸异山梨酯 5/40 mg 美国公开标签与两个准确包装面板（SPL v14；2026-02-06 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8ddd2577-311a-4967-bb67-ad72e2b76f83", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-31", "reviewedAt": "2026-08-31" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-isordil-isosorbide-dinitrate-5mg-oral-tablet-nda-012093-product-007-ndc-0187015201", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=5-mg-label.jpg&archiveid=949353", "alt": "ISORDIL TITRADOSE 硝酸异山梨酯 5 mg、100 片、NDC 0187-0152-01 的美国 DailyMed 标签面板", "archiveMarket": "美国", "labelVersion": "DailyMed SPL v14；2026-02-06 生效；NDC 营销结束日期 2025-08-31", "presentation": "ISORDIL TITRADOSE 普通口服片，每片 5 mg，100 片瓶装，NDC 0187-0152-01。", "notice": "此图只对应美国 DailyMed 记录中的 5 mg、100 片瓶装；其 NDC 营销结束日期已经列出。它不代表当前供应，不代表 40 mg 包装、10/20/30 mg 历史产品、舌下片、缓释片或其他市场产品，且不用于鉴定真伪。", "source": { "id": "src_9457a99656cefcba", "label": "DailyMed（NLM）：ISORDIL TITRADOSE 硝酸异山梨酯 5/40 mg 美国公开标签与两个准确包装面板（SPL v14；2026-02-06 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8ddd2577-311a-4967-bb67-ad72e2b76f83", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-31", "reviewedAt": "2026-08-31" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "ISORDIL 说明书放大阅读：普通口服预防片不是急性胸痛急救药", "en": "ISORDIL enlarged label: an immediate-release oral preventive tablet is not acute chest-pain rescue" }, "summary": { "zh": "ISORDIL TITRADOSE 是硝酸异山梨酯普通口服片。美国标签明确，它的起效不够快，不能用于终止急性心绞痛。网页不根据标签生成个人服用时间表或所谓“无硝酸酯间隔”。", "en": "ISORDIL TITRADOSE is an immediate-release oral isosorbide dinitrate tablet. The U.S. label states that onset is not rapid enough to abort an acute angina episode. The site does not generate an individual schedule or nitrate-free interval from the label." }, "checks": [ { "zh": "先核对途径和释放方式：本页是口服普通片，不是舌下片，也不是缓释片；不要与 IMDUR、MONOKET、NITROSTAT 或历史 ISORDIL 舌下/缓释产品按 mg 换算、轮换或替代。", "en": "Check route and release design first: this page covers immediate-release oral tablets, not sublingual or extended-release products. Do not convert, alternate or substitute by milligrams with IMDUR, MONOKET, NITROSTAT or historical ISORDIL sublingual/extended-release products." }, { "zh": "西地那非、他达拉非、伐地那非等 PDE-5 抑制剂，以及可溶性鸟苷酸环化酶刺激剂利奥西呱，与 ISORDIL 属于禁忌核对场景；不要自行错开几小时来规避。", "en": "PDE-5 inhibitors such as sildenafil, tadalafil or vardenafil, and the soluble guanylate cyclase stimulator riociguat, are contraindication-review scenarios with ISORDIL. Do not invent a few-hour separation to bypass them." }, { "zh": "头晕、直立性低血压和晕厥可能发生；与降压药、其他血管扩张药、利尿剂或酒精同在药单时要优先核对。老人起身不稳、跌倒或晕厥应及时评估。", "en": "Dizziness, postural hypotension and syncope may occur. Co-listing antihypertensives, other vasodilators, diuretics or alcohol requires priority review. Unsteadiness on standing, a fall or fainting in an older person needs timely assessment." }, { "zh": "5 mg 与 40 mg 标签片都有深刻痕，但刻痕只是外观身份字段；网页不据此允许自行掰片。请按手中准确产品说明书和开方团队指示核对。", "en": "The labelled 5 mg and 40 mg tablets are deeply scored, but the score is an appearance-identity field and does not permit self-splitting from a website. Check the exact product label and prescriber instructions." }, { "zh": "头痛可能与硝酸酯作用有关，但不能据此自行加量、减量、停药、换药或改变服用时刻。胸痛或头痛突然严重、不同寻常或伴神经系统症状时，应立即使用当地医疗支持。", "en": "Headache may accompany nitrate action, but it is not a basis for self-increasing, reducing, stopping, switching or changing timing. Sudden severe or unusual chest pain or headache, especially with neurological symptoms, needs immediate local medical support." } ], "source": { "id": "src_9457a99656cefcba", "label": "DailyMed（NLM）：ISORDIL TITRADOSE 硝酸异山梨酯 5/40 mg 美国公开标签与两个准确包装面板（SPL v14；2026-02-06 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8ddd2577-311a-4967-bb67-ad72e2b76f83", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-31", "reviewedAt": "2026-08-31" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "硝酸异山梨酯怎样起作用：扩张静脉和动脉，降低心脏负荷", "en": "How isosorbide dinitrate works: venous and arterial dilation reduces cardiac workload" }, "summary": { "zh": "有机硝酸酯使血管平滑肌松弛，尤其扩张静脉，从而减少回心血量和心肌耗氧。这既解释了预防心绞痛的作用，也解释了头痛、头晕和低血压风险；机制不能变成个人片数或换药公式。", "en": "Organic nitrates relax vascular smooth muscle, especially veins, reducing venous return and myocardial oxygen demand. This helps explain angina prevention as well as headache, dizziness and hypotension; the mechanism is not an individual tablet-count or switching formula." }, "checks": [ { "zh": "普通口服片仍不是急救药；“立即释放”只描述剂型，不保证足够快地终止急性发作。", "en": "An immediate-release oral tablet is still not a rescue medicine; immediate release describes the dosage form and does not guarantee onset rapid enough to abort an acute attack." }, { "zh": "长期连续暴露可能产生耐受，但标签中的专业时间安排不能被网页复制成个人用药时刻表；不要自行漏服、延后或停药来制造间隔。", "en": "Continuous exposure can produce tolerance, but professional scheduling language in the label must not become a web-generated individual timetable. Do not self-skip, delay or stop doses to create an interval." }, { "zh": "二硝酸酯可代谢为单硝酸酯衍生物，并不表示 ISORDIL 与 IMDUR 是同一产品；成分、剂型、途径、释放方式和说明书都要分别核对。", "en": "Isosorbide dinitrate forms mononitrate metabolites, but that does not make ISORDIL and IMDUR the same product. Ingredient, dosage form, route, release design and label must remain separate." } ], "source": { "id": "src_9457a99656cefcba", "label": "DailyMed（NLM）：ISORDIL TITRADOSE 硝酸异山梨酯 5/40 mg 美国公开标签与两个准确包装面板（SPL v14；2026-02-06 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8ddd2577-311a-4967-bb67-ad72e2b76f83", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-31", "reviewedAt": "2026-08-31" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "ISORDIL", "generic": "硝酸异山梨酯", "dosageFormClass": "普通口服片，5/10/20/30/40 mg。ISORDIL 历史另有舌下片与缓释片 NDA，本档案不把那些途径或释放方式并入口服普通片，也不与 IMDUR、MONOKET、NITROSTAT 或 BiDil 换算。" }, "labelSource": { "id": "src_9457a99656cefcba", "label": "DailyMed（NLM）：ISORDIL TITRADOSE 硝酸异山梨酯 5/40 mg 美国公开标签与两个准确包装面板（SPL v14；2026-02-06 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8ddd2577-311a-4967-bb67-ad72e2b76f83", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-31", "reviewedAt": "2026-08-31" }, "productRoutes": [ { "source": { "id": "src_9457a99656cefcba", "label": "DailyMed（NLM）：ISORDIL TITRADOSE 硝酸异山梨酯 5/40 mg 美国公开标签与两个准确包装面板（SPL v14；2026-02-06 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8ddd2577-311a-4967-bb67-ad72e2b76f83", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-31", "reviewedAt": "2026-08-31" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-31", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_10e511bf83430e3b", "label": "FDA Orange Book：ISORDIL 硝酸异山梨酯 NDA 012093 五个普通口服片 RLD 产品状态", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-08-29", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-31", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "ISORDIL 是硝酸异山梨酯普通口服片品牌档案，用于预防心绞痛；美国标签明确其起效不够快，不能用于终止一次急性心绞痛发作。新发、异常、剧烈或持续胸痛，或伴呼吸困难、出汗、晕厥时，应立即使用当地紧急医疗流程，不要等待口服片起效或自行追加。", "history": "FDA Orange Book 当前数据把 NDA 012093 的五种普通口服片均列出，并将批准日期记录为 1988-07-29。DailyMed SPL v14 于 2026-02-06 生效，保留 5 mg 与 40 mg 的 100 片瓶装面板及其营销结束日期；因此准确包装只作为有日期标签证据，而不是当前供应证明。", "sourceDocuments": [ { "id": "src_9457a99656cefcba", "label": "DailyMed（NLM）：ISORDIL TITRADOSE 硝酸异山梨酯 5/40 mg 美国公开标签与两个准确包装面板（SPL v14；2026-02-06 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8ddd2577-311a-4967-bb67-ad72e2b76f83", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-31", "reviewedAt": "2026-08-31" }, { "id": "src_10e511bf83430e3b", "label": "FDA Orange Book：ISORDIL 硝酸异山梨酯 NDA 012093 五个普通口服片 RLD 产品状态", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } ], "applicationNumber": "美国 NDA 012093（本档案仅普通口服片）", "approvalTimeline": [ { "date": "1988-07-29", "title": { "zh": "FDA Orange Book 当前数据记录五种普通口服片批准日期", "en": "Current FDA Orange Book data record the approval date for five immediate-release oral tablets" }, "detail": { "zh": "5/10/20/30/40 mg 均在 NDA 012093 下，当前产品状态不同。", "en": "The 5/10/20/30/40 mg products are under NDA 012093 and have different current product statuses." }, "source": { "id": "src_10e511bf83430e3b", "label": "FDA Orange Book：ISORDIL 硝酸异山梨酯 NDA 012093 五个普通口服片 RLD 产品状态", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } }, { "date": "2026-02-06", "title": { "zh": "DailyMed SPL v14 生效", "en": "DailyMed SPL version 14 became effective" }, "detail": { "zh": "公开标签保留 5 mg 与 40 mg 的准确产品面板，并列出营销结束日期。", "en": "The public label retains exact 5 mg and 40 mg panels and lists marketing-end dates." }, "source": { "id": "src_9457a99656cefcba", "label": "DailyMed（NLM）：ISORDIL TITRADOSE 硝酸异山梨酯 5/40 mg 美国公开标签与两个准确包装面板（SPL v14；2026-02-06 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8ddd2577-311a-4967-bb67-ad72e2b76f83", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-31", "reviewedAt": "2026-08-31" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "5/40 mg 当前 RX RLD；10/20/30 mg DISCN", "en": "5/40 mg current RX RLD; 10/20/30 mg DISCN" }, "detail": { "zh": "40 mg 同时为 RS；DailyMed 精确包装营销结束日期单独显示，不推定实时供应。", "en": "40 mg is also the RS; exact DailyMed package marketing-end dates are shown separately and do not establish live supply." } }, { "market": { "zh": "其他市场", "en": "Other markets" }, "status": { "zh": "本页未建立 ISORDIL 准确品牌产品状态", "en": "No exact ISORDIL brand-product status established on this page" }, "detail": { "zh": "不得用美国 NDA、标签或包装推定中国大陆、英国、欧盟、日本或其他市场的批准、供应或可替代性。", "en": "The U.S. NDA, label or pack must not be used to infer approval, supply or interchangeability in Mainland China, the UK, EU, Japan or another market." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "胸痛发作时能不能多吃一片 ISORDIL？", "en": "Can I take an extra ISORDIL tablet during chest pain?" }, "answer": { "zh": "不要根据网页这样做。口服 ISORDIL 起效不够快，不能终止急性发作；突然或加重胸痛应按既有急救计划和当地紧急医疗流程处理。", "en": "Do not do this from a website. Oral ISORDIL does not act rapidly enough to abort an acute attack; sudden or worsening chest pain requires the existing emergency plan and local urgent-care pathway." } }, { "question": { "zh": "有刻痕就可以掰半吗？", "en": "Does a score mean the tablet can be halved?" }, "answer": { "zh": "不能只凭刻痕决定。刻痕在本页用于识别准确标签产品；是否分片必须核对手中产品的现行说明书、处方和专业指示。", "en": "A score alone does not decide this. It identifies the exact labelled product on this page; splitting requires the current label, prescription and professional instruction for the product in hand." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "dose-unit-literacy", "same-class-is-not-same-medicine" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/isordil-isosorbide-dinitrate/", "en": "https://origindrug.com/en/drugs/isordil-isosorbide-dinitrate/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "ceftin", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-29", "status": "published_traceable_archive" }, "names": { "brand": "CEFTIN", "generic": "头孢呋辛酯", "aliases": [ "Ceftin", "cefuroxime axetil", "cefuroxime", "头孢呋辛酯", "头孢呋辛酯片", "头孢呋辛酯混悬剂", "头孢呋辛", "NDA 050605", "NDA 050672", "DIN 02212307", "125 mg/5 mL" ], "marketBrandNames": [ { "name": "CEFTIN", "market": { "zh": "美国", "en": "United States" }, "evidenceStatus": "historical_regulatory_record", "note": { "zh": "FDA Orange Book 历史 RLD；片剂与混悬剂当前均列为 Discontinued。", "en": "Historical FDA Orange Book RLD; tablets and suspension are currently listed as discontinued." }, "source": { "id": "src_10e511bf83430e3b", "label": "FDA Orange Book：CEFTIN（cefuroxime axetil）NDA 050605 片剂与 NDA 050672 混悬剂历史 RLD 记录", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } }, { "name": "CEFTIN", "market": { "zh": "加拿大", "en": "Canada" }, "evidenceStatus": "current_regulatory_record", "note": { "zh": "Health Canada 当前 DIN 02212307：125 mg/5 mL 混悬剂颗粒，Sandoz Canada。", "en": "Current Health Canada DIN 02212307: 125 mg/5 mL granules for suspension, Sandoz Canada." }, "source": { "id": "src_f569b57eee87a182", "label": "Health Canada：药品产品数据库（DPD）当前访问页；在库内核对 CEFTIN 125 mg/5 mL／DIN 02212307", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_lookup_entry", "documentKind": "regulatory_lookup", "market": "CA", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-09-13", "reviewedAt": "2026-09-13" } } ], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "感染", "sourceArchiveMarket": "美国 FDA Orange Book：NDA 050605 三个片剂强度与 NDA 050672 两个混悬剂浓度均为历史 RLD、当前列为 Discontinued；加拿大 Health Canada：DIN 02212307 的 125 mg/5 mL 混悬剂颗粒当前列为 Marketed", "dosageFormClass": "头孢呋辛酯口服片与复溶后口服混悬剂；每片 mg 与每 5 mL 的 mg/5 mL 是不同计量基础，不能按数字直接互换", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "1987（美国片剂）；1994（美国混悬剂）；加拿大当前记录另行列示", "archiveSponsorText": "美国历史 NDA：GlaxoSmithKline；加拿大当前 DIN：Sandoz Canada Inc." }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [ "cefuroxime sodium injection", "头孢呋辛钠注射剂", "generic cefuroxime axetil tablet", "其他厂牌头孢呋辛酯" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-ceftin-cefuroxime-axetil-tablet-125-nda-050605-product-001-historical", "marketCode": "US", "labelVersion": { "zh": "FDA Orange Book 当前数据中的历史产品身份（2026-08-29 核验）", "en": "Historical product identity in the current FDA Orange Book dataset (checked 29 Aug 2026)" }, "dosageForm": { "zh": "CEFTIN 头孢呋辛酯口服片（美国历史 RLD）", "en": "CEFTIN cefuroxime axetil oral tablet (historical U.S. RLD)" }, "route": { "zh": "口服（历史监管产品身份字段）", "en": "oral (historical regulatory product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDA 050605 / Product 001", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片相当于头孢呋辛 125；美国历史 RLD，当前列为停止销售", "en": "Equivalent to cefuroxime 125 per tablet; historical U.S. RLD currently listed as discontinued" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "头孢呋辛（以头孢呋辛酯提供）", "en": "cefuroxime (supplied as cefuroxime axetil)" }, "value": 125, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片历史监管标示量；不是个人片数、频率或疗程", "en": "historical regulatory amount per tablet; not an individual's tablet count, frequency or course" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-29", "currentLabelDisplayed": false, "ndcDirectoryListed": false, "marketAvailability": "historical_discontinued_rld", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": null, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_10e511bf83430e3b", "label": "FDA Orange Book：CEFTIN（cefuroxime axetil）NDA 050605 片剂与 NDA 050672 混悬剂历史 RLD 记录", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-ceftin-cefuroxime-axetil-tablet-250-nda-050605-product-002-historical", "marketCode": "US", "labelVersion": { "zh": "FDA Orange Book 当前数据中的历史产品身份（2026-08-29 核验）", "en": "Historical product identity in the current FDA Orange Book dataset (checked 29 Aug 2026)" }, "dosageForm": { "zh": "CEFTIN 头孢呋辛酯口服片（美国历史 RLD）", "en": "CEFTIN cefuroxime axetil oral tablet (historical U.S. RLD)" }, "route": { "zh": "口服（历史监管产品身份字段）", "en": "oral (historical regulatory product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDA 050605 / Product 002", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片相当于头孢呋辛 250；美国历史 RLD，当前列为停止销售", "en": "Equivalent to cefuroxime 250 per tablet; historical U.S. RLD currently listed as discontinued" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "头孢呋辛（以头孢呋辛酯提供）", "en": "cefuroxime (supplied as cefuroxime axetil)" }, "value": 250, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片历史监管标示量；不是个人片数、频率或疗程", "en": "historical regulatory amount per tablet; not an individual's tablet count, frequency or course" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-29", "currentLabelDisplayed": false, "ndcDirectoryListed": false, "marketAvailability": "historical_discontinued_rld", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": null, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_10e511bf83430e3b", "label": "FDA Orange Book：CEFTIN（cefuroxime axetil）NDA 050605 片剂与 NDA 050672 混悬剂历史 RLD 记录", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-ceftin-cefuroxime-axetil-tablet-500-nda-050605-product-003-historical", "marketCode": "US", "labelVersion": { "zh": "FDA Orange Book 当前数据中的历史产品身份（2026-08-29 核验）", "en": "Historical product identity in the current FDA Orange Book dataset (checked 29 Aug 2026)" }, "dosageForm": { "zh": "CEFTIN 头孢呋辛酯口服片（美国历史 RLD）", "en": "CEFTIN cefuroxime axetil oral tablet (historical U.S. RLD)" }, "route": { "zh": "口服（历史监管产品身份字段）", "en": "oral (historical regulatory product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDA 050605 / Product 003", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片相当于头孢呋辛 500；美国历史 RLD，当前列为停止销售", "en": "Equivalent to cefuroxime 500 per tablet; historical U.S. RLD currently listed as discontinued" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "头孢呋辛（以头孢呋辛酯提供）", "en": "cefuroxime (supplied as cefuroxime axetil)" }, "value": 500, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片历史监管标示量；不是个人片数、频率或疗程", "en": "historical regulatory amount per tablet; not an individual's tablet count, frequency or course" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-29", "currentLabelDisplayed": false, "ndcDirectoryListed": false, "marketAvailability": "historical_discontinued_rld", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": null, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_10e511bf83430e3b", "label": "FDA Orange Book：CEFTIN（cefuroxime axetil）NDA 050605 片剂与 NDA 050672 混悬剂历史 RLD 记录", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-ceftin-cefuroxime-axetil-suspension-125-nda-050672-product-001-historical", "marketCode": "US", "labelVersion": { "zh": "FDA Orange Book 当前数据中的历史产品身份（2026-08-29 核验）", "en": "Historical product identity in the current FDA Orange Book dataset (checked 29 Aug 2026)" }, "dosageForm": { "zh": "CEFTIN 头孢呋辛酯口服混悬剂用粉末（美国历史 RLD）", "en": "CEFTIN cefuroxime axetil powder for oral suspension (historical U.S. RLD)" }, "route": { "zh": "口服（历史监管产品身份字段）", "en": "oral (historical regulatory product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDA 050672 / Product 001", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_5_mL_after_reconstitution", "primaryDisplay": { "zh": "复溶后每 5 mL 相当于头孢呋辛 125；美国历史 RLD，当前列为停止销售", "en": "Equivalent to cefuroxime 125 per 5 mL after reconstitution; historical U.S. RLD currently listed as discontinued" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "头孢呋辛（以头孢呋辛酯提供）", "en": "cefuroxime (supplied as cefuroxime axetil)" }, "value": 125, "unit": "mg", "basisCode": "per_5_mL_after_reconstitution", "basisLabel": { "zh": "复溶后每 5 mL 的历史监管浓度；不是个人毫升数、频率或疗程", "en": "historical regulatory concentration per 5 mL after reconstitution; not an individual's millilitres, frequency or course" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-29", "currentLabelDisplayed": false, "ndcDirectoryListed": false, "marketAvailability": "historical_discontinued_rld", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": null, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_10e511bf83430e3b", "label": "FDA Orange Book：CEFTIN（cefuroxime axetil）NDA 050605 片剂与 NDA 050672 混悬剂历史 RLD 记录", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-ceftin-cefuroxime-axetil-suspension-250-nda-050672-product-002-historical", "marketCode": "US", "labelVersion": { "zh": "FDA Orange Book 当前数据中的历史产品身份（2026-08-29 核验）", "en": "Historical product identity in the current FDA Orange Book dataset (checked 29 Aug 2026)" }, "dosageForm": { "zh": "CEFTIN 头孢呋辛酯口服混悬剂用粉末（美国历史 RLD）", "en": "CEFTIN cefuroxime axetil powder for oral suspension (historical U.S. RLD)" }, "route": { "zh": "口服（历史监管产品身份字段）", "en": "oral (historical regulatory product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDA 050672 / Product 002", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_5_mL_after_reconstitution", "primaryDisplay": { "zh": "复溶后每 5 mL 相当于头孢呋辛 250；美国历史 RLD，当前列为停止销售", "en": "Equivalent to cefuroxime 250 per 5 mL after reconstitution; historical U.S. RLD currently listed as discontinued" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "头孢呋辛（以头孢呋辛酯提供）", "en": "cefuroxime (supplied as cefuroxime axetil)" }, "value": 250, "unit": "mg", "basisCode": "per_5_mL_after_reconstitution", "basisLabel": { "zh": "复溶后每 5 mL 的历史监管浓度；不是个人毫升数、频率或疗程", "en": "historical regulatory concentration per 5 mL after reconstitution; not an individual's millilitres, frequency or course" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-29", "currentLabelDisplayed": false, "ndcDirectoryListed": false, "marketAvailability": "historical_discontinued_rld", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": null, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_10e511bf83430e3b", "label": "FDA Orange Book：CEFTIN（cefuroxime axetil）NDA 050605 片剂与 NDA 050672 混悬剂历史 RLD 记录", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "ca-ceftin-cefuroxime-axetil-granules-for-suspension-125mg-5ml-din-02212307", "marketCode": "CA", "labelVersion": { "zh": "Health Canada 当前产品专论（2025-10-03）", "en": "Current Health Canada product monograph (3 Oct 2025)" }, "dosageForm": { "zh": "CEFTIN 头孢呋辛酯口服混悬剂用颗粒", "en": "CEFTIN cefuroxime axetil granules for oral suspension" }, "route": { "zh": "口服（加拿大当前市场记录）", "en": "oral (current Canadian market record)" }, "routeCodes": [ "oral" ], "productCode": "DIN 02212307", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_5_mL_after_reconstitution", "primaryDisplay": { "zh": "复溶后每 5 mL 相当于头孢呋辛 125 mg；当前公开记录未据此建立个人毫升数", "en": "Equivalent to cefuroxime 125 mg per 5 mL after reconstitution; the public record does not establish an individual's millilitres" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "头孢呋辛（以头孢呋辛酯提供）", "en": "cefuroxime (supplied as cefuroxime axetil)" }, "value": 125, "unit": "mg", "basisCode": "per_5_mL_after_reconstitution", "basisLabel": { "zh": "复溶后每 5 mL 的标签浓度；不是个人毫升数、频率或疗程", "en": "labelled concentration per 5 mL after reconstitution; not an individual's millilitres, frequency or course" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-29", "currentLabelDisplayed": true, "ndcDirectoryListed": false, "marketAvailability": "marketed_regulatory_record", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": null, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_f569b57eee87a182", "label": "Health Canada：药品产品数据库（DPD）当前访问页；在库内核对 CEFTIN 125 mg/5 mL／DIN 02212307", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_lookup_entry", "documentKind": "regulatory_lookup", "market": "CA", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-09-13", "reviewedAt": "2026-09-13" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "status": "withheld_repackaged_or_non_exact_visual", "title": { "zh": "已建立六个官方文字产品身份；没有用仿制药、零售图或历史图冒充原品牌包装", "en": "Six official text product identities are established; no generic, retail or historical image is presented as an originator-brand pack" }, "summary": { "zh": "FDA 数据可核实美国五个历史产品的剂型、强度、NDA、产品号、RLD 与停止销售状态；Health Canada 可核实当前加拿大 DIN、剂型与浓度。现有官方来源没有提供与这六个身份一一对应、可安全公开展示的原品牌包装主展示面，因此页面显示来源可追溯文字卡与可放大说明书，并明确暂无准确包装图。", "en": "FDA data verify dosage form, strength, NDA, product number, RLD and discontinued status for five historical U.S. products; Health Canada verifies the current Canadian DIN, form and concentration. The reviewed official sources do not provide an originator-brand principal display panel safely matched one-to-one to all six identities, so the page shows traceable text cards and an enlarged label while explicitly disclosing the image gap." }, "source": { "id": "src_f569b57eee87a182", "label": "Health Canada：药品产品数据库（DPD）当前访问页；在库内核对 CEFTIN 125 mg/5 mL／DIN 02212307", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_lookup_entry", "documentKind": "regulatory_lookup", "market": "CA", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-09-13", "reviewedAt": "2026-09-13" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "CEFTIN 说明书放大阅读：先分清每片 mg、复溶后 mg/5 mL 和个人毫升数", "en": "CEFTIN label reading: separate mg per tablet, mg/5 mL after reconstitution and an individual's millilitres" }, "summary": { "zh": "加拿大当前产品专论把 CEFTIN 写为复溶后 125 mg/5 mL 的口服混悬剂。125 mg/5 mL 是浓度，不是每次 5 mL，也不是任何人的剂量；实际毫升数、频率和疗程必须回到准确处方、年龄/体重、感染情况、肾功能和给药器。", "en": "The current Canadian monograph identifies CEFTIN as an oral suspension containing 125 mg/5 mL after reconstitution. 125 mg/5 mL is a concentration, not an instruction to take 5 mL and not anyone's dose. Actual millilitres, frequency and course must return to the exact prescription, age/weight, infection context, kidney function and dosing device." }, "checks": [ { "zh": "片剂的 125、250、500 mg 是每片标签量；混悬剂的 125 或 250 mg/5 mL 是复溶后每 5 mL 的浓度。不能只让数字相同就把片剂与混悬剂按毫克对毫升自行替代；FDA 标签资料还指出两种剂型并非生物等效，不能按毫克对毫克直接替换。", "en": "Tablet 125, 250 and 500 mg values are per tablet; suspension 125 or 250 mg/5 mL values are concentrations per 5 mL after reconstitution. Matching numbers do not permit self-substitution between tablets and suspension, and FDA label material states that the forms are not bioequivalent and are not directly substitutable milligram for milligram." }, { "zh": "加拿大当前混悬剂应按药房配制后的标签与口服给药器量取；普通厨房勺不是准确给药器。产品专论要求冷藏 2–8°C，并在 10 天后丢弃剩余复溶液。网页不会把浓度转换为个人毫升数。", "en": "Use the pharmacy label and an oral dosing device for the reconstituted Canadian suspension; an ordinary kitchen spoon is not an accurate dosing device. The monograph requires refrigeration at 2–8°C and disposal of the remaining reconstituted suspension after 10 days. The site does not convert the concentration into individual millilitres." }, { "zh": "加拿大专论建议与食物同用以获得最佳吸收；但页面不决定个人时刻，也不把该说明外推到美国历史片剂、其他厂牌或不同市场产品。先核对手中准确药盒和当地现行说明书。", "en": "The Canadian monograph recommends use with food for optimal absorption, but this page does not decide personal timing or extend that statement to historical U.S. tablets, another brand or another market. Check the exact pack and current local label first." }, { "zh": "使用前应告知头孢菌素、青霉素或其他药物过敏史，以及肾功能问题和完整药单。呼吸困难、面唇舌喉肿胀、晕厥、严重皮肤反应或胸部不适伴过敏表现需要立即使用当地急救服务；严重、持续或带血腹泻需要尽快医疗评估。", "en": "Before use, disclose cephalosporin, penicillin or other drug allergies, kidney problems and the complete medicine list. Breathing difficulty, swelling of the face/lips/tongue/throat, fainting, a severe skin reaction or chest discomfort with allergic features requires immediate local emergency care. Severe, persistent or bloody diarrhoea needs prompt medical assessment." }, { "zh": "减酸药、氨基糖苷类、利尿药以及其他处方药、非处方药和补充剂都应放入完整药单交给药师或开方团队核对。网页不会仅凭两个药名自动判定可以同服、需要错开或怎样调整。", "en": "Acid-reducing medicines, aminoglycosides, diuretics and all other prescription, OTC and supplement products belong on the complete medicine list for pharmacist or prescriber review. The site does not decide co-use, separation or adjustment from two medicine names alone." } ], "source": { "id": "src_93c13b714db1437d", "label": "Health Canada：CEFTIN 头孢呋辛酯混悬剂当前产品专论与患者用药信息（2025-10-03）", "url": "https://pdf.hres.ca/dpd_pm/00081954.PDF", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_pdf", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "头孢呋辛怎样起作用：抑制细菌细胞壁合成，不表示对所有发热或咳嗽都有效", "en": "How cefuroxime works: inhibiting bacterial cell-wall synthesis does not mean it treats every fever or cough" }, "summary": { "zh": "头孢呋辛酯口服后转化为头孢呋辛，通过与细菌青霉素结合蛋白相互作用、抑制细胞壁合成发挥抗菌作用。机制只帮助理解药物类别，不能仅凭症状判断病原、敏感性、是否需要抗菌药或疗程。", "en": "After oral administration, cefuroxime axetil is converted to cefuroxime, which acts through bacterial penicillin-binding proteins and inhibition of cell-wall synthesis. The mechanism explains the class but cannot establish the organism, susceptibility, need for an antibacterial or course from symptoms alone." }, "checks": [ { "zh": "抗菌药不治疗普通病毒性感冒。不要拿剩药、与家人共用、因症状相似自行开始，或在感觉好转后自行缩短处方疗程。", "en": "Antibacterials do not treat an ordinary viral cold. Do not use leftovers, share, self-start because symptoms seem similar or shorten a prescribed course because you feel better." }, { "zh": "CEFTIN、KEFLEX、阿莫西林、AUGMENTIN、ZITHROMAX、LEVAQUIN 等不是按毫克数字自行替换、轮换或叠加的一种药。药物类别、病原与药敏、感染部位、过敏史、肾功能和完整药单都会影响专业判断。", "en": "CEFTIN, KEFLEX, amoxicillin, AUGMENTIN, ZITHROMAX and LEVAQUIN are not one medicine that can be self-switched, alternated or combined from milligram numbers. Class, organism and susceptibility, infection site, allergy history, kidney function and the complete medicine list all affect professional judgement." }, { "zh": "网页只解释准确产品与官方说明书，不替个人选择抗菌药、计算片数或毫升数，也不判断是否需要培养、药敏或复诊。", "en": "The site explains the exact product and official label. It does not select an antibacterial, calculate tablets or millilitres, or decide whether culture, susceptibility testing or follow-up is needed for an individual." } ], "source": { "id": "src_93c13b714db1437d", "label": "Health Canada：CEFTIN 头孢呋辛酯混悬剂当前产品专论与患者用药信息（2025-10-03）", "url": "https://pdf.hres.ca/dpd_pm/00081954.PDF", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_pdf", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "CEFTIN", "generic": "头孢呋辛酯", "dosageFormClass": "头孢呋辛酯口服片与复溶后口服混悬剂；每片 mg 与每 5 mL 的 mg/5 mL 是不同计量基础，不能按数字直接互换" }, "labelSource": { "id": "src_93c13b714db1437d", "label": "Health Canada：CEFTIN 头孢呋辛酯混悬剂当前产品专论与患者用药信息（2025-10-03）", "url": "https://pdf.hres.ca/dpd_pm/00081954.PDF", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_pdf", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "productRoutes": [ { "source": { "id": "src_93c13b714db1437d", "label": "Health Canada：CEFTIN 头孢呋辛酯混悬剂当前产品专论与患者用药信息（2025-10-03）", "url": "https://pdf.hres.ca/dpd_pm/00081954.PDF", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_pdf", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "status": "product_level_public_record_verified", "authority": { "zh": "Health Canada", "en": "Health Canada" }, "market": { "zh": "加拿大", "en": "Canada" }, "recordType": { "zh": "监管产品记录或当前产品专论", "en": "Regulatory product record or current product monograph" }, "reviewedAt": "2026-08-29", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_10e511bf83430e3b", "label": "FDA Orange Book：CEFTIN（cefuroxime axetil）NDA 050605 片剂与 NDA 050672 混悬剂历史 RLD 记录", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-08-29", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "Health Canada", "en": "Health Canada" }, "market": { "zh": "加拿大", "en": "Canada" }, "recordType": { "zh": "监管产品记录或当前产品专论", "en": "Regulatory product record or current product monograph" }, "reviewedAt": "2026-08-29", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "CEFTIN 是头孢呋辛酯品牌档案。美国历史记录包含 125、250、500 mg 片剂和 125、250 mg/5 mL 混悬剂，当前均列为停止销售；加拿大当前记录是 125 mg/5 mL 混悬剂颗粒。最重要的是先看剂型和计量单位：片剂写的是每片 mg，混悬剂写的是复溶后每 5 mL 含多少 mg，两个数字不能直接当成个人片数或毫升数。", "history": "FDA Orange Book 记录 CEFTIN 片剂于 1987-12-28 获批，125 mg/5 mL 与 250 mg/5 mL 混悬剂分别于 1994-06-30 与 1997-04-29 获批；当前均为停止销售的历史 RLD 记录。Health Canada 当前产品数据库另列 DIN 02212307、125 mg/5 mL 混悬剂颗粒为 Marketed，产品专论日期为 2025-10-03。", "sourceDocuments": [ { "id": "src_10e511bf83430e3b", "label": "FDA Orange Book：CEFTIN（cefuroxime axetil）NDA 050605 片剂与 NDA 050672 混悬剂历史 RLD 记录", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, { "id": "src_3fe7f0d27d7c8b9e", "label": "FDA：CEFTIN NDA 050605/S-051 与 NDA 050672/S-037 补充批准信（2019-04-25）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/50605Orig1s051;%2050672Orig1s037ltr.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "approval_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_pdf", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, { "id": "src_f569b57eee87a182", "label": "Health Canada：药品产品数据库（DPD）当前访问页；在库内核对 CEFTIN 125 mg/5 mL／DIN 02212307", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_lookup_entry", "documentKind": "regulatory_lookup", "market": "CA", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-09-13", "reviewedAt": "2026-09-13" }, { "id": "src_93c13b714db1437d", "label": "Health Canada：CEFTIN 头孢呋辛酯混悬剂当前产品专论与患者用药信息（2025-10-03）", "url": "https://pdf.hres.ca/dpd_pm/00081954.PDF", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_pdf", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } ], "applicationNumber": "FDA NDA 050605（CEFTIN 片剂）／NDA 050672（CEFTIN 混悬剂）；Health Canada DIN 02212307（当前 125 mg/5 mL 混悬剂）", "approvalTimeline": [ { "date": "1987-12-28", "title": { "zh": "FDA 批准 CEFTIN 口服片", "en": "FDA approved CEFTIN oral tablets" }, "detail": { "zh": "Orange Book 当前数据将 125、250、500 mg 片剂与 NDA 050605、RLD 身份和现行 Discontinued 状态相连。", "en": "The current Orange Book dataset links 125, 250 and 500 mg tablets to NDA 050605, RLD identity and current discontinued status." }, "source": { "id": "src_10e511bf83430e3b", "label": "FDA Orange Book：CEFTIN（cefuroxime axetil）NDA 050605 片剂与 NDA 050672 混悬剂历史 RLD 记录", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } }, { "date": "1994-06-30", "title": { "zh": "FDA 批准 125 mg/5 mL 混悬剂", "en": "FDA approved the 125 mg/5 mL suspension" }, "detail": { "zh": "该产品属于 NDA 050672；250 mg/5 mL 产品后来于 1997-04-29 获批。两者当前均列为 Discontinued。", "en": "This product belongs to NDA 050672; the 250 mg/5 mL product was later approved on 29 Apr 1997. Both are currently listed as discontinued." }, "source": { "id": "src_10e511bf83430e3b", "label": "FDA Orange Book：CEFTIN（cefuroxime axetil）NDA 050605 片剂与 NDA 050672 混悬剂历史 RLD 记录", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } }, { "date": "2019-04-25", "title": { "zh": "FDA 批准 CEFTIN 标签补充申请", "en": "FDA approved CEFTIN labelling supplements" }, "detail": { "zh": "批准信同时连接 NDA 050605 片剂与 NDA 050672 混悬剂，是有日期的历史监管节点；它不是当前库存或重新上市结论。", "en": "The approval letter links the tablet and suspension NDAs as a dated regulatory node; it is not a finding of current stock or relaunch." }, "source": { "id": "src_3fe7f0d27d7c8b9e", "label": "FDA：CEFTIN NDA 050605/S-051 与 NDA 050672/S-037 补充批准信（2019-04-25）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/50605Orig1s051;%2050672Orig1s037ltr.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "approval_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_pdf", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } }, { "date": "2025-10-03", "title": { "zh": "Health Canada 当前产品专论日期", "en": "Current Health Canada monograph date" }, "detail": { "zh": "DIN 02212307 当前列为 Marketed，剂型为混悬剂颗粒、浓度 125 mg/5 mL，持有人为 Sandoz Canada Inc.。", "en": "DIN 02212307 is currently listed as marketed: granules for suspension, 125 mg/5 mL, held by Sandoz Canada Inc." }, "source": { "id": "src_f569b57eee87a182", "label": "Health Canada：药品产品数据库（DPD）当前访问页；在库内核对 CEFTIN 125 mg/5 mL／DIN 02212307", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_lookup_entry", "documentKind": "regulatory_lookup", "market": "CA", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-09-13", "reviewedAt": "2026-09-13" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "五个历史 RLD 产品当前均列为 Discontinued", "en": "Five historical RLD products are currently listed as discontinued" }, "detail": { "zh": "保留 FDA 监管身份用于历史追溯，不表示有库存、可购买、适合个人或可与当前仿制药直接互换。", "en": "The FDA identities are retained for historical traceability and do not establish stock, purchasing availability, individual suitability or direct interchangeability with a current generic." } }, { "market": { "zh": "加拿大", "en": "Canada" }, "status": { "zh": "DIN 02212307 的 125 mg/5 mL 混悬剂颗粒当前列为 Marketed", "en": "DIN 02212307 125 mg/5 mL granules for suspension are currently listed as marketed" }, "detail": { "zh": "“Marketed”是监管数据库状态，不表示任何具体药店有库存，也不是个人购买或使用建议。", "en": "‘Marketed’ is a regulatory-database status, not proof of stock at a particular pharmacy or an individual purchasing or use recommendation." } }, { "market": { "zh": "中国大陆、欧盟、日本及其他市场", "en": "Mainland China, EU, Japan and other markets" }, "status": { "zh": "待逐项建立现行市场记录", "en": "Current market record not established" }, "detail": { "zh": "不从美国或加拿大品牌记录推定当地商品名、批准、持有人、包装、供应、原研/仿制关系或可替代性。", "en": "No local trade name, approval, holder, pack, supply, originator/generic relationship or interchangeability is inferred from U.S. or Canadian brand records." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "瓶上写 125 mg/5 mL，是不是每次都喝 5 mL？", "en": "Does 125 mg/5 mL mean taking 5 mL every time?" }, "answer": { "zh": "不是。它表示复溶后每 5 mL 中含 125 mg，是浓度。个人毫升数、频率和疗程必须来自准确处方与药房标签，并用合适的口服给药器量取。", "en": "No. It is the concentration: 125 mg in each 5 mL after reconstitution. Individual millilitres, frequency and course must come from the exact prescription and pharmacy label and be measured with an appropriate oral dosing device." } }, { "question": { "zh": "同样写 250 mg，片剂和 250 mg/5 mL 混悬剂可以直接换吗？", "en": "Can a 250 mg tablet and 250 mg/5 mL suspension be directly exchanged?" }, "answer": { "zh": "不能仅按数字自行换。前者是每片量，后者是复溶后浓度；剂型、吸收和配制方式不同，FDA 资料还明确两种剂型并非生物等效、不能按毫克对毫克直接替换。请让药师或开方团队核对准确产品和处方。", "en": "Do not self-exchange them from the number alone. One is an amount per tablet and the other is a concentration after reconstitution. Their forms, absorption and preparation differ, and FDA material states that the forms are not bioequivalent or directly substitutable milligram for milligram. Ask the pharmacist or prescriber to check the exact product and prescription." } }, { "question": { "zh": "美国 CEFTIN 停止销售，是否表示因为不安全？", "en": "Does discontinued U.S. CEFTIN mean it was unsafe?" }, "answer": { "zh": "不能这样推断。FDA Orange Book 对 NDA 050605 片剂记录了“并非因安全性或有效性原因撤市”的联邦公报判定；网页仍不据此判断具体停产原因、当前库存或其他市场状态。", "en": "That inference is not justified. The FDA Orange Book records a Federal Register determination that the NDA 050605 tablets were not discontinued or withdrawn for safety or effectiveness reasons. The site still does not infer a particular commercial reason, current stock or another market's status." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "dosage-forms-are-part-of-medicine-identity", "how-to-read-a-drug-label" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/ceftin/", "en": "https://origindrug.com/en/drugs/ceftin/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "rayos", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-29", "status": "published_traceable_archive" }, "names": { "brand": "RAYOS", "generic": "泼尼松（延迟释放）", "aliases": [ "Rayos", "prednisone delayed-release", "delayed-release prednisone", "泼尼松延迟释放片", "泼尼松缓释片", "prednisone", "泼尼松", "NDA 202020", "75987-020-01", "75987-020-02", "75987-021-01", "75987-021-02", "75987-022-01", "75987-022-02", "NP 1", "NP 2", "NP 5" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "免疫", "sourceArchiveMarket": "美国 FDA NDA 202020 历史与当前申请状态：RAYOS 1 mg、2 mg、5 mg 延迟释放片均列为 Discontinued；RLD 为 Yes；本页使用 2024-06 标签作为最近核验的有日期说明书", "dosageFormClass": "泼尼松延迟释放片：每片 1 mg、2 mg 或 5 mg；六个历史瓶装身份；不是普通即释泼尼松片，也不是持续整天匀速释放的同义词", "dosageFormClassCode": "oral_modified_release", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "2012", "archiveSponsorText": "Horizon Pharma USA, Inc.（FDA 2024 有日期标签所列）" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [ "immediate-release prednisone", "prednisone regular tablet", "泼尼松普通片", "prednisolone", "泼尼松龙", "methylprednisolone", "甲泼尼龙" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-rayos-prednisone-delayed-release-1mg-30-tablet-bottle-ndc-7598702001", "marketCode": "US", "labelVersion": { "zh": "FDA 有日期美国处方信息（2024-06 修订；SUPPL-013）", "en": "Dated U.S. FDA prescribing information (revised Jun 2024; SUPPL-013)" }, "dosageForm": { "zh": "RAYOS 泼尼松延迟释放口服片", "en": "RAYOS prednisone delayed-release oral tablet" }, "route": { "zh": "口服（完整延迟释放片身份字段）", "en": "oral (intact delayed-release tablet identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 75987-020-01", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片泼尼松 1 mg；30 片瓶装；美国品牌产品已停止销售", "en": "Prednisone 1 mg per tablet; 30-tablet bottle; U.S. brand product discontinued" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "泼尼松", "en": "prednisone" }, "value": 1, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、服用时间、递减或停药指令", "en": "labelled amount per tablet; not an individual's tablet count, timing, taper or stopping instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-29", "currentLabelDisplayed": false, "ndcDirectoryListed": false, "marketAvailability": "historical_discontinued_brand", "marketingStartDate": null, "marketingEndDate": "not_stated_in_reviewed_label", "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 30, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "淡黄白色", "en": "pale yellowish-white" }, "shape": { "zh": "淡黄白色、圆形、无刻痕；一面压印 NP，另一面压印 1；延迟释放包衣必须保持完整", "en": "pale yellowish-white, round and unscored; debossed NP on one side and 1 on the other; the delayed-release coating must remain intact" }, "imprint": "NP / 1", "scoreStatus": "unscored_do_not_split", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_00c0b3c6df760392", "label": "FDA：RAYOS（prednisone）延迟释放片美国处方信息（NDA 202020；2024-06 修订）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/202020s013lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-rayos-prednisone-delayed-release-1mg-100-tablet-bottle-ndc-7598702002", "marketCode": "US", "labelVersion": { "zh": "FDA 有日期美国处方信息（2024-06 修订；SUPPL-013）", "en": "Dated U.S. FDA prescribing information (revised Jun 2024; SUPPL-013)" }, "dosageForm": { "zh": "RAYOS 泼尼松延迟释放口服片", "en": "RAYOS prednisone delayed-release oral tablet" }, "route": { "zh": "口服（完整延迟释放片身份字段）", "en": "oral (intact delayed-release tablet identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 75987-020-02", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片泼尼松 1 mg；100 片瓶装；美国品牌产品已停止销售", "en": "Prednisone 1 mg per tablet; 100-tablet bottle; U.S. brand product discontinued" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "泼尼松", "en": "prednisone" }, "value": 1, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、服用时间、递减或停药指令", "en": "labelled amount per tablet; not an individual's tablet count, timing, taper or stopping instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-29", "currentLabelDisplayed": false, "ndcDirectoryListed": false, "marketAvailability": "historical_discontinued_brand", "marketingStartDate": null, "marketingEndDate": "not_stated_in_reviewed_label", "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "淡黄白色", "en": "pale yellowish-white" }, "shape": { "zh": "淡黄白色、圆形、无刻痕；一面压印 NP，另一面压印 1；延迟释放包衣必须保持完整", "en": "pale yellowish-white, round and unscored; debossed NP on one side and 1 on the other; the delayed-release coating must remain intact" }, "imprint": "NP / 1", "scoreStatus": "unscored_do_not_split", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_00c0b3c6df760392", "label": "FDA：RAYOS（prednisone）延迟释放片美国处方信息（NDA 202020；2024-06 修订）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/202020s013lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-rayos-prednisone-delayed-release-2mg-30-tablet-bottle-ndc-7598702101", "marketCode": "US", "labelVersion": { "zh": "FDA 有日期美国处方信息（2024-06 修订；SUPPL-013）", "en": "Dated U.S. FDA prescribing information (revised Jun 2024; SUPPL-013)" }, "dosageForm": { "zh": "RAYOS 泼尼松延迟释放口服片", "en": "RAYOS prednisone delayed-release oral tablet" }, "route": { "zh": "口服（完整延迟释放片身份字段）", "en": "oral (intact delayed-release tablet identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 75987-021-01", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片泼尼松 2 mg；30 片瓶装；美国品牌产品已停止销售", "en": "Prednisone 2 mg per tablet; 30-tablet bottle; U.S. brand product discontinued" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "泼尼松", "en": "prednisone" }, "value": 2, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、服用时间、递减或停药指令", "en": "labelled amount per tablet; not an individual's tablet count, timing, taper or stopping instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-29", "currentLabelDisplayed": false, "ndcDirectoryListed": false, "marketAvailability": "historical_discontinued_brand", "marketingStartDate": null, "marketingEndDate": "not_stated_in_reviewed_label", "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 30, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "黄白色", "en": "yellowish-white" }, "shape": { "zh": "黄白色、圆形、无刻痕；一面压印 NP，另一面压印 2；延迟释放包衣必须保持完整", "en": "yellowish-white, round and unscored; debossed NP on one side and 2 on the other; the delayed-release coating must remain intact" }, "imprint": "NP / 2", "scoreStatus": "unscored_do_not_split", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_00c0b3c6df760392", "label": "FDA：RAYOS（prednisone）延迟释放片美国处方信息（NDA 202020；2024-06 修订）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/202020s013lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-rayos-prednisone-delayed-release-2mg-100-tablet-bottle-ndc-7598702102", "marketCode": "US", "labelVersion": { "zh": "FDA 有日期美国处方信息（2024-06 修订；SUPPL-013）", "en": "Dated U.S. FDA prescribing information (revised Jun 2024; SUPPL-013)" }, "dosageForm": { "zh": "RAYOS 泼尼松延迟释放口服片", "en": "RAYOS prednisone delayed-release oral tablet" }, "route": { "zh": "口服（完整延迟释放片身份字段）", "en": "oral (intact delayed-release tablet identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 75987-021-02", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片泼尼松 2 mg；100 片瓶装；美国品牌产品已停止销售", "en": "Prednisone 2 mg per tablet; 100-tablet bottle; U.S. brand product discontinued" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "泼尼松", "en": "prednisone" }, "value": 2, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、服用时间、递减或停药指令", "en": "labelled amount per tablet; not an individual's tablet count, timing, taper or stopping instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-29", "currentLabelDisplayed": false, "ndcDirectoryListed": false, "marketAvailability": "historical_discontinued_brand", "marketingStartDate": null, "marketingEndDate": "not_stated_in_reviewed_label", "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "黄白色", "en": "yellowish-white" }, "shape": { "zh": "黄白色、圆形、无刻痕；一面压印 NP，另一面压印 2；延迟释放包衣必须保持完整", "en": "yellowish-white, round and unscored; debossed NP on one side and 2 on the other; the delayed-release coating must remain intact" }, "imprint": "NP / 2", "scoreStatus": "unscored_do_not_split", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_00c0b3c6df760392", "label": "FDA：RAYOS（prednisone）延迟释放片美国处方信息（NDA 202020；2024-06 修订）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/202020s013lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-rayos-prednisone-delayed-release-5mg-30-tablet-bottle-ndc-7598702201", "marketCode": "US", "labelVersion": { "zh": "FDA 有日期美国处方信息（2024-06 修订；SUPPL-013）", "en": "Dated U.S. FDA prescribing information (revised Jun 2024; SUPPL-013)" }, "dosageForm": { "zh": "RAYOS 泼尼松延迟释放口服片", "en": "RAYOS prednisone delayed-release oral tablet" }, "route": { "zh": "口服（完整延迟释放片身份字段）", "en": "oral (intact delayed-release tablet identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 75987-022-01", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片泼尼松 5 mg；30 片瓶装；美国品牌产品已停止销售", "en": "Prednisone 5 mg per tablet; 30-tablet bottle; U.S. brand product discontinued" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "泼尼松", "en": "prednisone" }, "value": 5, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、服用时间、递减或停药指令", "en": "labelled amount per tablet; not an individual's tablet count, timing, taper or stopping instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-29", "currentLabelDisplayed": false, "ndcDirectoryListed": false, "marketAvailability": "historical_discontinued_brand", "marketingStartDate": null, "marketingEndDate": "not_stated_in_reviewed_label", "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 30, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "浅黄色", "en": "light yellow" }, "shape": { "zh": "浅黄色、圆形、无刻痕；一面压印 NP，另一面压印 5；延迟释放包衣必须保持完整", "en": "light yellow, round and unscored; debossed NP on one side and 5 on the other; the delayed-release coating must remain intact" }, "imprint": "NP / 5", "scoreStatus": "unscored_do_not_split", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_00c0b3c6df760392", "label": "FDA：RAYOS（prednisone）延迟释放片美国处方信息（NDA 202020；2024-06 修订）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/202020s013lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-rayos-prednisone-delayed-release-5mg-100-tablet-bottle-ndc-7598702202", "marketCode": "US", "labelVersion": { "zh": "FDA 有日期美国处方信息（2024-06 修订；SUPPL-013）", "en": "Dated U.S. FDA prescribing information (revised Jun 2024; SUPPL-013)" }, "dosageForm": { "zh": "RAYOS 泼尼松延迟释放口服片", "en": "RAYOS prednisone delayed-release oral tablet" }, "route": { "zh": "口服（完整延迟释放片身份字段）", "en": "oral (intact delayed-release tablet identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 75987-022-02", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片泼尼松 5 mg；100 片瓶装；美国品牌产品已停止销售", "en": "Prednisone 5 mg per tablet; 100-tablet bottle; U.S. brand product discontinued" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "泼尼松", "en": "prednisone" }, "value": 5, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、服用时间、递减或停药指令", "en": "labelled amount per tablet; not an individual's tablet count, timing, taper or stopping instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-29", "currentLabelDisplayed": false, "ndcDirectoryListed": false, "marketAvailability": "historical_discontinued_brand", "marketingStartDate": null, "marketingEndDate": "not_stated_in_reviewed_label", "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "浅黄色", "en": "light yellow" }, "shape": { "zh": "浅黄色、圆形、无刻痕；一面压印 NP，另一面压印 5；延迟释放包衣必须保持完整", "en": "light yellow, round and unscored; debossed NP on one side and 5 on the other; the delayed-release coating must remain intact" }, "imprint": "NP / 5", "scoreStatus": "unscored_do_not_split", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_00c0b3c6df760392", "label": "FDA：RAYOS（prednisone）延迟释放片美国处方信息（NDA 202020；2024-06 修订）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/202020s013lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "status": "withheld_repackaged_or_non_exact_visual", "title": { "zh": "已核验历史标签中的颜色、刻字、强度、NDC 与瓶装数量；没有把文字外观冒充为当前包装图片", "en": "Historical label text verifies colour, imprint, strength, NDC and bottle count; text-only appearance is not presented as a current package image" }, "summary": { "zh": "FDA 2024 标签列出三种无刻痕圆片和六个历史瓶装 NDC，但本次没有取得与每个包装一一对应、可安全公开展示的官方主展示面。由于 Drugs@FDA 当前状态为 Discontinued，页面只展示可追溯文字身份和可放大说明书，不使用零售图、二手交易图或其他泼尼松产品图片代替。", "en": "The 2024 FDA label lists three round unscored tablets and six historical bottle NDCs, but this review did not obtain an official principal display panel safely matched one-to-one to every pack. Because Drugs@FDA now lists the products as discontinued, the page shows traceable text identity and an enlarged label without substituting retail, resale or another prednisone product image." }, "source": { "id": "src_00c0b3c6df760392", "label": "FDA：RAYOS（prednisone）延迟释放片美国处方信息（NDA 202020；2024-06 修订）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/202020s013lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "RAYOS 说明书放大阅读：延迟释放不是普通片，包衣必须保持完整", "en": "RAYOS label reading: delayed release is not a regular tablet, and the coating must remain intact" }, "summary": { "zh": "FDA 有日期说明书要求随食物整片吞服，并明确不得掰开、分割或咀嚼。标签体外试验显示包衣使药物约延迟 4 小时才开始释放；这解释剂型差异，不是任何人的服药时刻、补服或换药指令。", "en": "The dated FDA label requires the tablet to be swallowed whole with food and says not to break, divide or chew it. Label in-vitro testing describes an approximately four-hour delay before release begins; this explains dosage-form identity and is not anyone's timing, make-up-dose or switching instruction." }, "checks": [ { "zh": "1、2、5 mg 是每片延迟释放片的标签标示量，不是一次吃几片。两个 1 mg 片在算术上虽合计 2 mg，也不能据此自行替代一片 2 mg、拼接处方或改变递减安排。", "en": "1, 2 and 5 mg are labelled amounts per delayed-release tablet, not tablets per dose. Although two 1 mg numbers add arithmetically to 2 mg, that does not permit self-substitution for one 2 mg tablet, prescription assembly or a change to a taper." }, { "zh": "不要自行掰、切、压碎或咀嚼 RAYOS。它没有刻痕，且标签说明延迟释放依赖完整包衣；若吞咽困难或处方需要更小强度，应让药师或开方团队核对准确产品和可行方案。", "en": "Do not self-break, cut, crush or chew RAYOS. It is unscored and the label explains that delayed release depends on an intact coating. If swallowing is difficult or the prescription needs a lower strength, ask the pharmacist or prescriber to review the exact product and feasible options." }, { "zh": "不要突然停用、照抄他人的递减表，或与 MEDROL、地塞米松、普通泼尼松等按毫克数自行换算。激素种类、释放方式、使用时间和个体情况不同；停用或转换需要负责治疗的专业人员决定。", "en": "Do not abruptly stop, copy another person's taper, or self-convert milligrams with MEDROL, dexamethasone or regular prednisone. Corticosteroid, release pattern, duration and individual circumstances differ; stopping or conversion requires the treating professional." }, { "zh": "感染暴露或发热、视力变化、明显情绪或行为改变、黑便/呕血、严重腹痛、显著水肿或气促等需要及时联系医疗人员；呼吸困难、面唇舌喉肿胀、晕厥或其他危重表现应立即使用当地急救服务。", "en": "Infection exposure or fever, vision change, marked mood or behaviour change, black stools or vomiting blood, severe abdominal pain, marked swelling or breathlessness need prompt medical contact. Breathing difficulty, swelling of the face/lips/tongue/throat, fainting or another critical feature requires immediate local emergency care." }, { "zh": "老年人、糖尿病、高血压、骨质疏松、胃肠道问题、肾肝功能异常或感染风险较高者，应把这些情况与完整药单交给专业人员核对。华法林、阿司匹林/NSAIDs、利尿药、地高辛、抗糖尿病药、利福平、苯妥英、酮康唑、环孢素、雌激素以及补充剂/草药都应列入药单。", "en": "Older adults and people with diabetes, hypertension, osteoporosis, gastrointestinal disease, kidney or liver impairment or higher infection risk should have these factors and the complete medicine list reviewed. Warfarin, aspirin/NSAIDs, diuretics, digoxin, diabetes medicines, rifampin, phenytoin, ketoconazole, cyclosporine, oestrogens, supplements and herbal products all belong on that list." } ], "source": { "id": "src_00c0b3c6df760392", "label": "FDA：RAYOS（prednisone）延迟释放片美国处方信息（NDA 202020；2024-06 修订）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/202020s013lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "RAYOS 怎样起作用：泼尼松经体内转化后产生糖皮质激素作用，延迟释放改变的是释放时点", "en": "How RAYOS works: prednisone is converted in the body for glucocorticoid effects, while delayed release changes the release timing" }, "summary": { "zh": "泼尼松在体内转化为具有活性的泼尼松龙，通过糖皮质激素相关通路产生广泛的抗炎和免疫作用。RAYOS 的核心产品差异是完整包衣造成的延迟释放；这不表示它整天匀速释放，也不证明比即释泼尼松更强、更安全或适合某个个人。", "en": "Prednisone is converted in the body to active prednisolone and produces broad anti-inflammatory and immune effects through glucocorticoid-related pathways. RAYOS's key product difference is delayed release from the intact coating. That does not mean constant all-day release or prove that it is stronger, safer or suitable for an individual compared with immediate-release prednisone." }, "checks": [ { "zh": "“延迟释放”表示释放开始时间被推后，不等于“持续释放”“缓慢整天释放”或所有写有 ER/XR/SR/MR 的产品。必须按准确商品名、剂型和说明书核对。", "en": "Delayed release means that release onset is postponed; it does not mean sustained release, constant all-day release or every product labelled ER/XR/SR/MR. Check the exact brand, dosage form and label." }, { "zh": "FDA 原始审评记录了 RAYOS 与即释泼尼松的药代和食物影响差异，但不能把这种剂型差异改写成疗效优越、可自行换算或可绕过处方的结论。", "en": "The FDA original review records pharmacokinetic and food-effect differences from immediate-release prednisone, but that dosage-form difference must not be rewritten as superior efficacy, self-convertibility or a way around a prescription." }, { "zh": "网页只解释产品身份和官方说明书。具体适应症、服用时间、剂量、疗程、递减和停药必须回到准确处方，并结合疾病、使用时长、既往反应和全部用药由专业人员核对。", "en": "The site explains product identity and the official label only. Indication, timing, amount, duration, taper and stopping must return to the exact prescription and professional review of the condition, duration of use, prior reactions and all medicines." } ], "source": { "id": "src_00c0b3c6df760392", "label": "FDA：RAYOS（prednisone）延迟释放片美国处方信息（NDA 202020；2024-06 修订）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/202020s013lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "RAYOS", "generic": "泼尼松（延迟释放）", "dosageFormClass": "泼尼松延迟释放片：每片 1 mg、2 mg 或 5 mg；六个历史瓶装身份；不是普通即释泼尼松片，也不是持续整天匀速释放的同义词" }, "labelSource": { "id": "src_00c0b3c6df760392", "label": "FDA：RAYOS（prednisone）延迟释放片美国处方信息（NDA 202020；2024-06 修订）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/202020s013lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "productRoutes": [ { "source": { "id": "src_00c0b3c6df760392", "label": "FDA：RAYOS（prednisone）延迟释放片美国处方信息（NDA 202020；2024-06 修订）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/202020s013lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-08-29", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_025e5f7a177cb85e", "label": "FDA Drugs@FDA：RAYOS（prednisone）NDA 202020 当前申请记录；1 mg、2 mg、5 mg 均列为 Discontinued，RLD 为 Yes", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=202020", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-08-29", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-08-29", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "RAYOS 是一种已经在美国停止销售的泼尼松延迟释放品牌档案。它的完整包衣使药物不是吞下后立即释放；FDA 标签要求随食物整片吞服，不能掰开、分割或咀嚼。本页帮助辨认 1、2、5 mg 的每片强度、六个历史 NDC、外观文字和重要安全问题；不会把历史档案写成当前库存，也不会生成个人片数、服用时间、递减或停药方案。", "history": "FDA 于 2012 年通过 505(b)(2) 路径批准 RAYOS。原始审评把它与即释泼尼松分开评价，记录延迟释放和食物影响；这不构成疗效优于普通泼尼松的结论。FDA 2024 标签和 SUPPL-013 批准信保留了最新有日期的说明书节点，而当前 Drugs@FDA 申请页已将三个强度全部列为 Discontinued。", "sourceDocuments": [ { "id": "src_00c0b3c6df760392", "label": "FDA：RAYOS（prednisone）延迟释放片美国处方信息（NDA 202020；2024-06 修订）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/202020s013lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, { "id": "src_025e5f7a177cb85e", "label": "FDA Drugs@FDA：RAYOS（prednisone）NDA 202020 当前申请记录；1 mg、2 mg、5 mg 均列为 Discontinued，RLD 为 Yes", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=202020", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, { "id": "src_5f240b25f31e1431", "label": "FDA：RAYOS NDA 202020 原始审评总结（2012；505(b)(2) 延迟释放泼尼松）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202020Orig1s000SumR.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_regulatory_record", "documentKind": "approval_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, { "id": "src_d4bb0a4137680005", "label": "FDA：RAYOS NDA 202020/S-013 补充批准信（2024-06-05）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/202020Orig1s013ltr.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "approval_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } ], "applicationNumber": "FDA NDA 202020（RAYOS / prednisone delayed-release tablets；美国 RLD，当前三种强度均为 Discontinued）", "approvalTimeline": [ { "date": "2012-07-26", "title": { "zh": "FDA 批准 RAYOS 延迟释放片", "en": "FDA approved RAYOS delayed-release tablets" }, "detail": { "zh": "FDA 原始审评将该 505(b)(2) NDA 与即释泼尼松参考药分开评价，记录延迟释放与食物影响。此节点用于追溯产品设计与批准，不是当前供应或相对疗效结论。", "en": "The FDA original review evaluated this 505(b)(2) NDA against an immediate-release prednisone reference and recorded delayed-release and food effects. This node traces product design and approval; it is not a current-supply or comparative-efficacy conclusion." }, "source": { "id": "src_5f240b25f31e1431", "label": "FDA：RAYOS NDA 202020 原始审评总结（2012；505(b)(2) 延迟释放泼尼松）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202020Orig1s000SumR.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_regulatory_record", "documentKind": "approval_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } }, { "date": "2024-06-05", "title": { "zh": "FDA 批准 SUPPL-013 标签更新", "en": "FDA approved the SUPPL-013 label update" }, "detail": { "zh": "FDA 批准信和 2024-06 处方信息构成本页最近核验的有日期说明书节点。文件日期不是产品仍有库存或已重新上市的证据。", "en": "The FDA approval letter and Jun 2024 prescribing information are the most recent dated label node reviewed here. A document date is not evidence of stock or relaunch." }, "source": { "id": "src_d4bb0a4137680005", "label": "FDA：RAYOS NDA 202020/S-013 补充批准信（2024-06-05）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/202020Orig1s013ltr.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "approval_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } }, { "date": "2026-08-29", "title": { "zh": "复核 Drugs@FDA 当前申请状态", "en": "Current Drugs@FDA application status reviewed" }, "detail": { "zh": "NDA 202020 当前申请页将 1、2、5 mg 三种延迟释放片均列为 Discontinued，并将 RLD 列为 Yes。该日期是本站核验日，不是监管决定日期。", "en": "The current NDA 202020 application page lists all 1, 2 and 5 mg delayed-release tablets as Discontinued and RLD as Yes. This is the site's review date, not a regulatory-decision date." }, "source": { "id": "src_025e5f7a177cb85e", "label": "FDA Drugs@FDA：RAYOS（prednisone）NDA 202020 当前申请记录；1 mg、2 mg、5 mg 均列为 Discontinued，RLD 为 Yes", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=202020", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "RLD 历史档案；1 mg、2 mg、5 mg 当前均列为 Discontinued", "en": "Historical RLD archive; 1 mg, 2 mg and 5 mg are currently listed as Discontinued" }, "detail": { "zh": "页面保留最近有日期的 FDA 标签、六个历史瓶装身份和当前申请状态。它不是库存、购买渠道、重新上市或个人适用性结论。", "en": "The page retains the most recent dated FDA label, six historical bottle identities and current application status. It is not a finding of stock, purchasing route, relaunch or individual suitability." } }, { "market": { "zh": "中国大陆、欧盟、日本及其他市场", "en": "Mainland China, EU, Japan and other markets" }, "status": { "zh": "待逐项建立现行市场记录", "en": "Current market record not established" }, "detail": { "zh": "不从美国 RAYOS 品牌、NDA、RLD 身份、通用名或外观推定当地商品名、批准、包装、供应、原研/仿制关系或可替代性。", "en": "No local trade name, approval, packaging, supply, originator/generic relationship or interchangeability is inferred from the U.S. RAYOS brand, NDA, RLD identity, generic name or appearance." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "RAYOS 是缓释片吗？是不是整天慢慢释放？", "en": "Is RAYOS an extended-release tablet that releases all day?" }, "answer": { "zh": "准确说它是延迟释放片：完整包衣让释放开始时间推后。它不等于所有“缓释/控释/长效”制剂，也不能据此推断整天匀速释放。核对时应使用完整商品名、剂型和官方说明书。", "en": "Its exact form is delayed release: the intact coating postpones the start of release. It is not equivalent to every sustained-, controlled- or extended-release product, and constant all-day release cannot be inferred. Use the full brand, dosage form and official label when checking it." } }, { "question": { "zh": "1 mg 片可以掰一半当 0.5 mg 吗？", "en": "Can a 1 mg tablet be split in half to make 0.5 mg?" }, "answer": { "zh": "不能自行这样做。RAYOS 标签把片剂列为无刻痕，并明确要求整片吞服、不得掰开、分割或咀嚼，因为延迟释放依赖完整包衣。需要更小强度或调整方案时，应让药师或开方团队核对准确处方和可用产品。", "en": "Do not do this yourself. The RAYOS label describes an unscored tablet and requires swallowing whole without breaking, dividing or chewing because delayed release depends on the intact coating. If a lower strength or change is needed, ask the pharmacist or prescriber to review the exact prescription and available product." } }, { "question": { "zh": "FDA 还有说明书，是否表示现在还能买到？", "en": "If FDA still has a label, is RAYOS still available?" }, "answer": { "zh": "不是。当前 Drugs@FDA 申请页将三个强度都列为 Discontinued。保留说明书和 NDA 是监管档案事实，不是库存、购买资格或重新上市结论。", "en": "No. The current Drugs@FDA application page lists all three strengths as Discontinued. A retained label and NDA are regulatory-record facts, not stock, purchasing eligibility or relaunch conclusions." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "dosage-forms-are-part-of-medicine-identity", "medicine-label-for-everyday-questions", "how-to-read-a-drug-label" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/rayos/", "en": "https://origindrug.com/en/drugs/rayos/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "glucotrol-xl", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-29", "status": "published_traceable_archive" }, "names": { "brand": "GLUCOTROL XL", "generic": "格列吡嗪缓释片", "aliases": [ "Glucotrol XL", "glipizide extended release", "glipizide ER", "glipizide XL", "格列吡嗪缓释片", "格列吡嗪控释片", "glipizide", "格列吡嗪", "瑞易宁", "NDA 020329", "0049-0170-01", "0049-0174-02", "0049-0174-03", "0049-0178-07", "0049-0178-08" ], "marketBrandNames": [ { "name": "GLUCOTROL XL", "market": { "zh": "美国", "en": "United States" }, "evidenceStatus": "current_regulatory_record", "note": { "zh": "NDA 020329；现行 DailyMed 品牌标签；5 mg、10 mg 当前 Orange Book 为处方 RLD，2.5 mg 为已停止销售 RLD。", "en": "NDA 020329; current DailyMed brand label; 5 mg and 10 mg are current prescription RLD entries, while 2.5 mg is a discontinued RLD entry in the Orange Book." }, "source": { "id": "src_10e511bf83430e3b", "label": "FDA Orange Book 当前数据：GLUCOTROL XL，NDA 020329；5 mg、10 mg 为处方 RLD，2.5 mg 为已停止销售 RLD", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } } ], "mainlandChinaTradeNameCue": { "value": "瑞易宁®", "status": "discovery_cue_requires_target_market_verification", "source": { "id": "src_281bcdb5add33c39", "label": "泾县人民政府：医保高值药品参考清单中的瑞易宁／格列吡嗪控释片记录", "url": "https://www.ahxx.gov.cn/group1/M00/47/45/Cpc8VmZo5wiAK4pvAAM6bEblTyM892.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "government_medicine_listing", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-12", "reviewedAt": "2026-09-12" } } }, "identity": { "therapeuticArea": "代谢", "sourceArchiveMarket": "美国 GLUCOTROL XL / glipizide extended-release tablets；NDA 020329；现行 DailyMed 标签列出 2.5、5、10 mg，Orange Book 当前数据将 5、10 mg 列为处方 RLD、2.5 mg 列为已停止销售 RLD", "dosageFormClass": "24 小时渗透泵缓释口服片：每片 2.5、5 或 10 mg；不是普通格列吡嗪片，也不是格列齐特缓释片", "dosageFormClassCode": "oral_modified_release", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "1994", "archiveSponsorText": "Roerig／Pfizer（DailyMed 当前标签所列）" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [ "immediate-release glipizide", "glipizide regular tablet", "格列吡嗪普通片", "gliclazide", "格列齐特", "DIAMICRON MR", "glimepiride", "格列美脲", "AMARYL" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-glucotrol-xl-glipizide-er-2-5mg-30-bottle-ndc-0049017001", "marketCode": "US", "labelVersion": { "zh": "DailyMed 美国现行公开标签（SPL v28，2026-07-21 生效）", "en": "Current U.S. DailyMed public label (SPL v28, effective 21 Jul 2026)" }, "dosageForm": { "zh": "GLUCOTROL XL 格列吡嗪缓释口服片", "en": "GLUCOTROL XL glipizide extended-release oral tablet" }, "route": { "zh": "口服（必须保持渗透泵缓释片完整）", "en": "oral (the osmotic extended-release tablet must remain intact)" }, "routeCodes": [ "oral" ], "productCode": "NDC 0049-0170-01", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片格列吡嗪 2.5 mg；30 片瓶装", "en": "Glipizide 2.5 mg per tablet; 30-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=glucotrol-xl-04.jpg&setid=eed99b60-d043-4249-9b2a-f05e46fb588d&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "格列吡嗪", "en": "glipizide" }, "value": 2.5, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、加减量或换药指令", "en": "labelled amount per tablet; not an individual's tablet count, adjustment or switching instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-29", "currentLabelDisplayed": false, "ndcDirectoryListed": true, "marketAvailability": "label_package_marketing_end_2023", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 30, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "蓝色", "en": "blue" }, "shape": { "zh": "圆形、双凸、无刻痕缓释片", "en": "round, biconvex, unscored extended-release tablet" }, "imprint": "GXL 2.5", "scoreStatus": "unscored_do_not_split", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_14f94310e9cfc4ec", "label": "DailyMed（NLM）：GLUCOTROL XL（glipizide）美国现行公开标签；SPL v28，2026-07-21 生效", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=eed99b60-d043-4249-9b2a-f05e46fb588d", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-glucotrol-xl-glipizide-er-5mg-100-bottle-ndc-0049017402", "marketCode": "US", "labelVersion": { "zh": "DailyMed 美国现行公开标签（SPL v28，2026-07-21 生效）", "en": "Current U.S. DailyMed public label (SPL v28, effective 21 Jul 2026)" }, "dosageForm": { "zh": "GLUCOTROL XL 格列吡嗪缓释口服片", "en": "GLUCOTROL XL glipizide extended-release oral tablet" }, "route": { "zh": "口服（必须保持渗透泵缓释片完整）", "en": "oral (the osmotic extended-release tablet must remain intact)" }, "routeCodes": [ "oral" ], "productCode": "NDC 0049-0174-02", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片格列吡嗪 5 mg；100 片瓶装", "en": "Glipizide 5 mg per tablet; 100-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=glucotrol-xl-05.jpg&setid=eed99b60-d043-4249-9b2a-f05e46fb588d&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "格列吡嗪", "en": "glipizide" }, "value": 5, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、加减量或换药指令", "en": "labelled amount per tablet; not an individual's tablet count, adjustment or switching instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-29", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "current_label_listed", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "白色", "en": "white" }, "shape": { "zh": "圆形、双凸、无刻痕缓释片", "en": "round, biconvex, unscored extended-release tablet" }, "imprint": "GXL 5", "scoreStatus": "unscored_do_not_split", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_14f94310e9cfc4ec", "label": "DailyMed（NLM）：GLUCOTROL XL（glipizide）美国现行公开标签；SPL v28，2026-07-21 生效", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=eed99b60-d043-4249-9b2a-f05e46fb588d", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-glucotrol-xl-glipizide-er-5mg-500-bottle-ndc-0049017403", "marketCode": "US", "labelVersion": { "zh": "DailyMed 美国现行公开标签（SPL v28，2026-07-21 生效）", "en": "Current U.S. DailyMed public label (SPL v28, effective 21 Jul 2026)" }, "dosageForm": { "zh": "GLUCOTROL XL 格列吡嗪缓释口服片", "en": "GLUCOTROL XL glipizide extended-release oral tablet" }, "route": { "zh": "口服（必须保持渗透泵缓释片完整）", "en": "oral (the osmotic extended-release tablet must remain intact)" }, "routeCodes": [ "oral" ], "productCode": "NDC 0049-0174-03", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片格列吡嗪 5 mg；500 片瓶装", "en": "Glipizide 5 mg per tablet; 500-tablet bottle" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "格列吡嗪", "en": "glipizide" }, "value": 5, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、加减量或换药指令", "en": "labelled amount per tablet; not an individual's tablet count, adjustment or switching instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 500, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-29", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "current_label_listed", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 500, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "白色", "en": "white" }, "shape": { "zh": "圆形、双凸、无刻痕缓释片", "en": "round, biconvex, unscored extended-release tablet" }, "imprint": "GXL 5", "scoreStatus": "unscored_do_not_split", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_14f94310e9cfc4ec", "label": "DailyMed（NLM）：GLUCOTROL XL（glipizide）美国现行公开标签；SPL v28，2026-07-21 生效", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=eed99b60-d043-4249-9b2a-f05e46fb588d", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-glucotrol-xl-glipizide-er-10mg-100-bottle-ndc-0049017807", "marketCode": "US", "labelVersion": { "zh": "DailyMed 美国现行公开标签（SPL v28，2026-07-21 生效）", "en": "Current U.S. DailyMed public label (SPL v28, effective 21 Jul 2026)" }, "dosageForm": { "zh": "GLUCOTROL XL 格列吡嗪缓释口服片", "en": "GLUCOTROL XL glipizide extended-release oral tablet" }, "route": { "zh": "口服（必须保持渗透泵缓释片完整）", "en": "oral (the osmotic extended-release tablet must remain intact)" }, "routeCodes": [ "oral" ], "productCode": "NDC 0049-0178-07", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片格列吡嗪 10 mg；100 片瓶装", "en": "Glipizide 10 mg per tablet; 100-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=glucotrol-xl-06.jpg&setid=eed99b60-d043-4249-9b2a-f05e46fb588d&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "格列吡嗪", "en": "glipizide" }, "value": 10, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、加减量或换药指令", "en": "labelled amount per tablet; not an individual's tablet count, adjustment or switching instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-29", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "current_label_listed", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "白色", "en": "white" }, "shape": { "zh": "圆形、双凸、无刻痕缓释片", "en": "round, biconvex, unscored extended-release tablet" }, "imprint": "GXL 10", "scoreStatus": "unscored_do_not_split", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_14f94310e9cfc4ec", "label": "DailyMed（NLM）：GLUCOTROL XL（glipizide）美国现行公开标签；SPL v28，2026-07-21 生效", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=eed99b60-d043-4249-9b2a-f05e46fb588d", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-glucotrol-xl-glipizide-er-10mg-500-bottle-ndc-0049017808", "marketCode": "US", "labelVersion": { "zh": "DailyMed 美国现行公开标签（SPL v28，2026-07-21 生效）", "en": "Current U.S. DailyMed public label (SPL v28, effective 21 Jul 2026)" }, "dosageForm": { "zh": "GLUCOTROL XL 格列吡嗪缓释口服片", "en": "GLUCOTROL XL glipizide extended-release oral tablet" }, "route": { "zh": "口服（必须保持渗透泵缓释片完整）", "en": "oral (the osmotic extended-release tablet must remain intact)" }, "routeCodes": [ "oral" ], "productCode": "NDC 0049-0178-08", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片格列吡嗪 10 mg；500 片瓶装", "en": "Glipizide 10 mg per tablet; 500-tablet bottle" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "格列吡嗪", "en": "glipizide" }, "value": 10, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、加减量或换药指令", "en": "labelled amount per tablet; not an individual's tablet count, adjustment or switching instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 500, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-29", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "current_label_listed", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 500, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "白色", "en": "white" }, "shape": { "zh": "圆形、双凸、无刻痕缓释片", "en": "round, biconvex, unscored extended-release tablet" }, "imprint": "GXL 10", "scoreStatus": "unscored_do_not_split", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_14f94310e9cfc4ec", "label": "DailyMed（NLM）：GLUCOTROL XL（glipizide）美国现行公开标签；SPL v28，2026-07-21 生效", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=eed99b60-d043-4249-9b2a-f05e46fb588d", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-glucotrol-xl-glipizide-er-5mg-100-bottle-ndc-0049017402", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=glucotrol-xl-05.jpg&setid=eed99b60-d043-4249-9b2a-f05e46fb588d&type=img", "alt": { "zh": "DailyMed 官方 GLUCOTROL XL 5 mg、100 片瓶装标签面板", "en": "Official DailyMed GLUCOTROL XL 5 mg 100-tablet bottle label panel" }, "archiveMarket": "美国", "labelVersion": "DailyMed 美国现行公开标签（SPL v28，2026-07-21 生效）", "presentation": "GLUCOTROL XL 格列吡嗪缓释片：每片 5 mg，NDC 0049-0174-02，100 片瓶装标签面板。", "notice": "此图只对应美国 DailyMed 当前标签中的 GLUCOTROL XL、格列吡嗪缓释片 5 mg、NDC 0049-0174-02 与 100 片瓶装。它只帮助核对品牌、通用名、每片标示量、缓释剂型、包装数量与来源；不用于鉴定真伪，也不证明 2.5 mg、10 mg、500 片瓶装、普通格列吡嗪片、其他市场、当前库存、可替代性或任何个人的片数、加减量、联用、停用或换药方案。", "source": { "id": "src_14f94310e9cfc4ec", "label": "DailyMed（NLM）：GLUCOTROL XL（glipizide）美国现行公开标签；SPL v28，2026-07-21 生效", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=eed99b60-d043-4249-9b2a-f05e46fb588d", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "GLUCOTROL XL 说明书放大阅读：不能掰碎，看到空壳通常不是漏吸收", "en": "GLUCOTROL XL label reading: do not split or crush; an empty shell usually does not mean failed absorption" }, "summary": { "zh": "GLUCOTROL XL 的药物装在不可溶解的外壳内，通过小孔缓慢释放。官方患者说明明确要求整片吞服，不得掰开、压碎、溶解、咀嚼或切半；释药后的空壳可能随大便排出。", "en": "GLUCOTROL XL contains medicine in a non-dissolvable shell that releases it slowly through a small opening. The official patient information says to swallow it whole and not break, crush, dissolve, chew or cut it in half; the empty shell may pass in stool after release." }, "checks": [ { "zh": "2.5、5、10 mg 是每片标签量，不是一次吃几片。即使标签中的研究记录某些多片组合具有生物等效性，也不能据此自行拼片、加减量、换成普通格列吡嗪或把别人的方案照搬。", "en": "2.5, 5 and 10 mg are labelled amounts per tablet, not tablets per dose. Even though the label records bioequivalence for certain multiple-tablet combinations in studies, that does not permit self-assembling tablets, changing amounts, switching to immediate-release glipizide or copying another person's regimen." }, { "zh": "整片吞服，不要掰、切、压碎、溶解或咀嚼。破坏渗透泵结构可能让过多药物一次释放；有吞咽困难时应带准确药盒询问药师或开方团队，不要自行改剂型。", "en": "Swallow whole; do not break, cut, crush, dissolve or chew. Damaging the osmotic system can release too much medicine at once. If swallowing is difficult, take the exact pack to a pharmacist or prescriber rather than changing the dosage form yourself." }, { "zh": "排便中看到像完整药片的东西，可能是已经释药的不可溶外壳。不要因为看到外壳就补吃一片或重复服用；若血糖异常、外壳频繁出现且有疑问或同时存在持续腹泻/肠道狭窄史，应联系专业人员。", "en": "Something resembling a whole tablet in stool may be the non-dissolvable shell after drug release. Do not take an extra tablet or repeat a dose because you see it. Contact a professional for abnormal glucose, persistent concern, continuing diarrhoea or a history of intestinal narrowing." }, { "zh": "低血糖可很严重；老人、肾肝功能异常、营养不足、进食减少、剧烈或长时间运动、饮酒，以及与其他降糖药同用时风险可能更高。意识不清、抽搐或无法安全吞咽属于急症，应立即使用当地急救服务，不要强行喂食。", "en": "Hypoglycaemia can be severe. Risk may be higher in older adults, kidney or liver impairment, malnutrition, reduced food intake, severe or prolonged exercise, alcohol use and with other glucose-lowering medicines. Confusion, seizure or inability to swallow safely is an emergency: use local emergency services and do not force food or drink." }, { "zh": "咪康唑、氟康唑、考来维仑、β 受体阻滞剂、其他降糖药及所有处方药、非处方药、草药和补充剂都应放入完整药单核对。网页不从两个药名自动决定能否同服、需要间隔多久或怎样调整。", "en": "Miconazole, fluconazole, colesevelam, beta-blockers, other diabetes medicines and every prescription, OTC, herbal and supplement product belong on the complete list for review. The site does not decide co-use, spacing or adjustment from two medicine names." } ], "source": { "id": "src_14f94310e9cfc4ec", "label": "DailyMed（NLM）：GLUCOTROL XL（glipizide）美国现行公开标签；SPL v28，2026-07-21 生效", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=eed99b60-d043-4249-9b2a-f05e46fb588d", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "格列吡嗪怎样起作用：促进仍有功能的胰岛 β 细胞释放胰岛素", "en": "How glipizide works: stimulating insulin release from functioning pancreatic beta cells" }, "summary": { "zh": "格列吡嗪属于磺脲类，主要通过促进仍有功能的胰岛 β 细胞释放胰岛素来降低血糖。GLUCOTROL XL 的渗透泵结构改变释放过程，不表示可以跳过进食、血糖监测或个体化评估，也不证明比其他降糖药更适合某个人。", "en": "Glipizide is a sulfonylurea that lowers glucose mainly by stimulating insulin release from functioning pancreatic beta cells. GLUCOTROL XL's osmotic system changes drug release; it does not remove the need for food, glucose monitoring or individual assessment and does not prove superiority for a person over another diabetes medicine." }, "checks": [ { "zh": "它不是胰岛素，也不用于 1 型糖尿病或糖尿病酮症酸中毒。疾病名称、一次血糖或家人的经验不能决定个人是否适合。", "en": "It is not insulin and is not for type 1 diabetes or diabetic ketoacidosis. A diagnosis label, one glucose reading or another person's experience cannot determine individual suitability." }, { "zh": "缓释结构和普通格列吡嗪的释放方式不同；不要按相同毫克数自行互换，也不要与格列齐特、格列美脲或其他磺脲类轮换或叠加。", "en": "Extended-release and immediate-release glipizide have different release patterns. Do not self-exchange them by matching milligrams, or rotate or combine them with gliclazide, glimepiride or another sulfonylurea." }, { "zh": "网页解释机制和标签，不替个人设定血糖目标、片数、服用时刻、漏服补服、停药或联合方案。请结合准确处方、进食情况、肾肝功能、低血糖史与完整药单由专业人员判断。", "en": "The site explains mechanism and label identity. It does not set an individual's glucose target, tablet count, timing, missed-use action, stopping or combination plan. Professional review requires the exact prescription, food intake, kidney and liver function, hypoglycaemia history and complete medicine list." } ], "source": { "id": "src_14f94310e9cfc4ec", "label": "DailyMed（NLM）：GLUCOTROL XL（glipizide）美国现行公开标签；SPL v28，2026-07-21 生效", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=eed99b60-d043-4249-9b2a-f05e46fb588d", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "GLUCOTROL XL", "generic": "格列吡嗪缓释片", "dosageFormClass": "24 小时渗透泵缓释口服片：每片 2.5、5 或 10 mg；不是普通格列吡嗪片，也不是格列齐特缓释片" }, "labelSource": { "id": "src_14f94310e9cfc4ec", "label": "DailyMed（NLM）：GLUCOTROL XL（glipizide）美国现行公开标签；SPL v28，2026-07-21 生效", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=eed99b60-d043-4249-9b2a-f05e46fb588d", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "productRoutes": [ { "source": { "id": "src_14f94310e9cfc4ec", "label": "DailyMed（NLM）：GLUCOTROL XL（glipizide）美国现行公开标签；SPL v28，2026-07-21 生效", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=eed99b60-d043-4249-9b2a-f05e46fb588d", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-29", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_10e511bf83430e3b", "label": "FDA Orange Book 当前数据：GLUCOTROL XL，NDA 020329；5 mg、10 mg 为处方 RLD，2.5 mg 为已停止销售 RLD", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-08-29", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-29", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "GLUCOTROL XL 是格列吡嗪缓释片，用于成年 2 型糖尿病患者配合饮食与运动改善血糖控制。药物装在不可溶解的渗透泵外壳中缓慢释放：必须整片吞服，不能掰、切、压碎、溶解或咀嚼；排便时偶尔看到像药片的空壳，通常不表示药没有吸收。网页只帮助辨认产品、读懂说明书和低血糖风险，不给个人剂量或换药方案。", "history": "FDA 于 1994 年批准 5 mg、10 mg GLUCOTROL XL，并于 1999 年批准 2.5 mg。当前官方数据仍把三个强度与 NDA 020329、RLD 身份相连；DailyMed 现行标签为 SPL v28、2026-07-21 生效。产品身份、标签日期与市场供应状态必须分别阅读。", "sourceDocuments": [ { "id": "src_14f94310e9cfc4ec", "label": "DailyMed（NLM）：GLUCOTROL XL（glipizide）美国现行公开标签；SPL v28，2026-07-21 生效", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=eed99b60-d043-4249-9b2a-f05e46fb588d", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, { "id": "src_10e511bf83430e3b", "label": "FDA Orange Book 当前数据：GLUCOTROL XL，NDA 020329；5 mg、10 mg 为处方 RLD，2.5 mg 为已停止销售 RLD", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, { "id": "src_ba0d4d24a4153f88", "label": "FDA：GLUCOTROL XL NDA 020329/S-035 补充批准信（2021-05-21）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/020329Orig1s035ltr.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "approval_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } ], "applicationNumber": "FDA NDA 020329（GLUCOTROL XL / glipizide extended-release tablets）", "approvalTimeline": [ { "date": "1994-04-26", "title": { "zh": "FDA 批准 5 mg 与 10 mg", "en": "FDA approved 5 mg and 10 mg" }, "detail": { "zh": "Orange Book 当前数据把两个强度与 NDA 020329 及 RLD 身份相连。", "en": "Current Orange Book data link both strengths to NDA 020329 and RLD identity." }, "source": { "id": "src_10e511bf83430e3b", "label": "FDA Orange Book 当前数据：GLUCOTROL XL，NDA 020329；5 mg、10 mg 为处方 RLD，2.5 mg 为已停止销售 RLD", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } }, { "date": "1999-08-10", "title": { "zh": "FDA 批准 2.5 mg", "en": "FDA approved 2.5 mg" }, "detail": { "zh": "当前 Orange Book 将该强度列为已停止销售的 RLD；DailyMed 标签仍保留其历史包装记录。", "en": "The current Orange Book lists this strength as a discontinued RLD; DailyMed retains its historical package record." }, "source": { "id": "src_10e511bf83430e3b", "label": "FDA Orange Book 当前数据：GLUCOTROL XL，NDA 020329；5 mg、10 mg 为处方 RLD，2.5 mg 为已停止销售 RLD", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } }, { "date": "2021-05-21", "title": { "zh": "FDA 批准 S-035 标签补充申请", "en": "FDA approved S-035 labelling supplement" }, "detail": { "zh": "批准信是有日期的监管节点；本页现行用药信息以更新后的 DailyMed 标签为准。", "en": "The approval letter is a dated regulatory node; current use information on this page follows the later DailyMed label." }, "source": { "id": "src_ba0d4d24a4153f88", "label": "FDA：GLUCOTROL XL NDA 020329/S-035 补充批准信（2021-05-21）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/020329Orig1s035ltr.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "approval_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } }, { "date": "2026-07-21", "title": { "zh": "DailyMed 当前标签生效日期", "en": "Current DailyMed label effective date" }, "detail": { "zh": "SPL v28 是本页核验的现行公开标签节点；标签日期不等于任何具体药店库存。", "en": "SPL v28 is the current public-label node reviewed here; a label date is not proof of stock at a particular pharmacy." }, "source": { "id": "src_14f94310e9cfc4ec", "label": "DailyMed（NLM）：GLUCOTROL XL（glipizide）美国现行公开标签；SPL v28，2026-07-21 生效", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=eed99b60-d043-4249-9b2a-f05e46fb588d", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "5 mg、10 mg 有现行公开品牌标签；2.5 mg 的 NDC 记录显示 2023 年营销结束", "en": "5 mg and 10 mg have a current public brand label; the 2.5 mg NDC record shows marketing ended in 2023" }, "detail": { "zh": "现行标签与 Orange Book 身份用于核实产品，不表示任何具体渠道有库存，也不是个人购买或用药建议。", "en": "The current label and Orange Book identity verify the product; they do not establish stock at a particular channel or provide individual purchasing or use advice." } }, { "market": { "zh": "中国大陆、欧盟、日本及其他市场", "en": "Mainland China, EU, Japan and other markets" }, "status": { "zh": "待逐项建立现行市场记录", "en": "Current market record not established" }, "detail": { "zh": "不从美国品牌、通用名或毫克数推定当地商品名、批准、包装、供应、原研/仿制关系或可替代性。", "en": "No local trade name, approval, pack, supply, originator/generic relationship or interchangeability is inferred from the U.S. brand, generic name or milligram amount." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "为什么大便里会看到像药片的东西？", "en": "Why might something resembling a tablet appear in stool?" }, "answer": { "zh": "GLUCOTROL XL 使用不可溶解的渗透泵外壳缓慢释放药物。药物释放后，空壳可能随大便排出，这是官方患者说明列出的现象。不要因此补吃；如血糖异常、持续担忧或伴肠道症状，请联系专业人员。", "en": "GLUCOTROL XL uses a non-dissolvable osmotic shell to release medicine slowly. The empty shell may pass in stool after release, as described in the official patient information. Do not take an extra tablet because of it; contact a professional for abnormal glucose, persistent concern or accompanying bowel symptoms." } }, { "question": { "zh": "5 mg 可以掰一半当 2.5 mg 吗？", "en": "Can a 5 mg tablet be split to make 2.5 mg?" }, "answer": { "zh": "不能自行这样做。片剂无刻痕，官方说明要求整片吞服，不得掰开、压碎、溶解、咀嚼或切半，因为这会破坏缓释结构。需要调整时应核对准确处方和可用产品。", "en": "Do not do this yourself. The tablet is unscored, and official information says to swallow it whole without breaking, crushing, dissolving, chewing or cutting it in half because this damages extended release. Any adjustment requires review of the exact prescription and available product." } }, { "question": { "zh": "和格列齐特缓释片、格列美脲是一种药吗？", "en": "Is it the same medicine as modified-release gliclazide or glimepiride?" }, "answer": { "zh": "不是。它们可能都属于磺脲类，但有效成分、产品身份、释放方式、强度与说明书不同，不能按毫克数自行替换、轮换或叠加。", "en": "No. They may all be sulfonylureas, but active ingredient, product identity, release pattern, strength and label differ. Do not self-substitute, rotate or combine them by milligram numbers." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "dosage-forms-are-part-of-medicine-identity", "how-to-read-a-drug-label" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/glucotrol-xl/", "en": "https://origindrug.com/en/drugs/glucotrol-xl/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "microzide", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-29", "status": "published_traceable_archive" }, "names": { "brand": "MICROZIDE", "generic": "氢氯噻嗪胶囊", "aliases": [ "Microzide", "hydrochlorothiazide", "HCTZ", "氢氯噻嗪", "氢氯噻嗪胶囊", "MICROZIDE 12.5 mg", "NDA 020504", "52544-622-01" ], "marketBrandNames": [ { "name": "MICROZIDE", "market": { "zh": "美国", "en": "United States" }, "evidenceStatus": "current_regulatory_record", "note": { "zh": "FDA Orange Book 当前数据：NDA 020504，氢氯噻嗪 12.5 mg 口服胶囊，处方药 RLD/RS；当前准确 NDC 与包装未在本次审阅中建立。", "en": "Current FDA Orange Book data: NDA 020504, hydrochlorothiazide 12.5 mg oral capsule, prescription RLD/RS; an exact current NDC and pack were not established in this review." }, "source": { "id": "src_10e511bf83430e3b", "label": "FDA Orange Book 当前数据：MICROZIDE（hydrochlorothiazide）NDA 020504，12.5 mg 口服胶囊；处方药 RLD 与 RS", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } } ], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "心血管", "sourceArchiveMarket": "美国：FDA Orange Book 当前数据列示 MICROZIDE、hydrochlorothiazide 12.5 mg、口服胶囊、NDA 020504、处方药 RLD/RS；页面另引用 2020 年 FDA 标签和已结束营销的 2011 年 DailyMed 准确包装，不把旧 NDC 或旧包装写成当前包装", "dosageFormClass": "氢氯噻嗪 12.5 mg 口服胶囊；不是氢氯噻嗪片，也不是已经含氢氯噻嗪的复方片", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "1996", "archiveSponsorText": "Teva Branded Pharmaceutical Products R&D LLC（FDA Orange Book 当前数据所列申请人）" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [ "hydrochlorothiazide tablet", "氢氯噻嗪片", "AVALIDE", "irbesartan hydrochlorothiazide", "EXFORGE HCT", "amlodipine valsartan hydrochlorothiazide", "HYZAAR", "losartan hydrochlorothiazide" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-microzide-hydrochlorothiazide-12-5mg-100-capsule-bottle-ndc-5254462201-historical", "marketCode": "US", "labelVersion": { "zh": "DailyMed 美国历史标签（2011-10 修订；该 NDC 营销结束 2020-08-31）", "en": "Historical U.S. DailyMed label (revised Oct 2011; marketing for this NDC ended 31 Aug 2020)" }, "dosageForm": { "zh": "MICROZIDE 氢氯噻嗪硬明胶口服胶囊", "en": "MICROZIDE hydrochlorothiazide hard-gelatin oral capsule" }, "route": { "zh": "口服（历史产品身份字段）", "en": "oral (historical product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 52544-622-01", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_capsule", "primaryDisplay": { "zh": "每粒氢氯噻嗪 12.5 mg；100 粒瓶装（历史包装）", "en": "Hydrochlorothiazide 12.5 mg per capsule; 100-capsule bottle (historical pack)" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=microzide-capsule-2.jpg&archiveid=377471", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "氢氯噻嗪", "en": "hydrochlorothiazide" }, "value": 12.5, "unit": "mg", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒历史标签标示量；不是个人粒数、频次或补服指令", "en": "historical labelled amount per capsule; not an individual's capsule count, frequency or missed-use instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装（历史）", "en": "bottle (historical)" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-29", "currentLabelDisplayed": false, "ndcDirectoryListed": false, "marketAvailability": "historical_label_marketing_end_2020", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "physicalClues": { "color": { "zh": "蓝绿色不透明", "en": "teal opaque" }, "shape": { "zh": "两节式 4 号硬明胶胶囊；无刻痕", "en": "two-piece size 4 hard-gelatin capsule; unscored" }, "imprint": "MICROZIDE / 12.5 mg", "scoreStatus": "capsule_not_a_split_tablet", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_46382e935f7dacef", "label": "DailyMed（NLM）：MICROZIDE 12.5 mg、NDC 52544-622-01、100 粒瓶装历史标签（2011-10 修订；营销结束 2020-08-31）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=afbefaff-97c4-4f84-b989-1595f882a885", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_archive", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-microzide-hydrochlorothiazide-12-5mg-100-capsule-bottle-ndc-5254462201-historical", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=microzide-capsule-2.jpg&archiveid=377471", "alt": { "zh": "DailyMed 历史 MICROZIDE 12.5 mg、NDC 52544-622-01、100 粒瓶装标签面板", "en": "Historical DailyMed MICROZIDE 12.5 mg, NDC 52544-622-01, 100-capsule bottle label panel" }, "archiveMarket": "美国", "labelVersion": "DailyMed 美国历史标签（2011-10 修订；营销结束 2020-08-31）", "presentation": "MICROZIDE 氢氯噻嗪胶囊：每粒 12.5 mg，NDC 52544-622-01，100 粒瓶装历史标签面板。", "notice": "此图只对应 DailyMed 2011 年历史标签中的 MICROZIDE、氢氯噻嗪 12.5 mg、NDC 52544-622-01 与 100 粒瓶装；该 NDC 的营销记录已于 2020-08-31 结束。图片不用于鉴定真伪，也不证明当前 NDC、当前包装、库存、其他市场、氢氯噻嗪片、任何复方药、可替代性或个人使用方案。", "source": { "id": "src_46382e935f7dacef", "label": "DailyMed（NLM）：MICROZIDE 12.5 mg、NDC 52544-622-01、100 粒瓶装历史标签（2011-10 修订；营销结束 2020-08-31）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=afbefaff-97c4-4f84-b989-1595f882a885", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_archive", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "MICROZIDE 说明书放大阅读：先查是否与复方药重复，再看水分与电解质信号", "en": "MICROZIDE label reading: check combination-product duplication first, then fluid and electrolyte signals" }, "summary": { "zh": "MICROZIDE 是每粒 12.5 mg 的氢氯噻嗪胶囊。12.5 mg 是每粒标签量，不是网页建议一次吃几粒；同一成分也可能藏在复方降压药里。", "en": "MICROZIDE is a hydrochlorothiazide capsule labelled 12.5 mg per capsule. The 12.5 mg is a product-identity amount, not this site's recommended capsule count, and the same ingredient may also be present inside a combination blood-pressure medicine." }, "checks": [ { "zh": "逐盒看“有效成分”。AVALIDE 已含厄贝沙坦/氢氯噻嗪，EXFORGE HCT 已含氨氯地平/缬沙坦/氢氯噻嗪；若完整药单还有 MICROZIDE 或另一盒 HCTZ，应交给药师或开方团队核对是否重复，不要自行停掉其中一盒。", "en": "Read the active ingredients on every pack. AVALIDE already contains irbesartan/hydrochlorothiazide, while EXFORGE HCT contains amlodipine/valsartan/hydrochlorothiazide. If MICROZIDE or another HCTZ product is also on the full list, ask a pharmacist or prescriber to check for duplication; do not stop one yourself." }, { "zh": "口干、明显口渴、乏力、嗜睡、烦躁、肌肉疼痛或抽筋、心跳加快、头晕、尿量明显减少、持续恶心或呕吐，可能与水分或电解质变化有关。严重、突然或伴晕厥、意识异常时应立即寻求当地急救。", "en": "Dry mouth, marked thirst, weakness, drowsiness, restlessness, muscle pain or cramps, fast heartbeat, dizziness, clearly reduced urine, persistent nausea or vomiting may accompany fluid or electrolyte changes. Seek local emergency help for severe or sudden symptoms, fainting or altered consciousness." }, { "zh": "老人、肾功能或肝功能异常、痛风或高尿酸、糖尿病，以及同时使用其他降压药、地高辛、激素、锂盐、止痛抗炎药或酒精时，都需要把准确药盒和完整药单一起核对。网页不从年龄、化验或血压数字自动给出加减量。", "en": "Older adults, kidney or liver impairment, gout or high urate, diabetes, and co-use of other blood-pressure medicines, digoxin, corticosteroids, lithium, pain or anti-inflammatory medicines, or alcohol all require review of the exact packs and complete medicine list. The site does not generate an adjustment from age, laboratory or blood-pressure numbers." }, { "zh": "突然眼痛、视力快速下降或明显视物模糊需要及时就医；出现面唇舌喉肿胀、呼吸困难或严重皮肤反应应使用当地急救服务。不要等待网页判断是否与药物有关。", "en": "Sudden eye pain, rapid loss of vision or marked blurred vision needs prompt medical assessment. Swelling of the face, lips, tongue or throat, breathing difficulty or a severe skin reaction requires local emergency services. Do not wait for the website to decide whether the medicine caused it." }, { "zh": "有日期的 FDA 标签提醒长期用药者做好防晒并按临床建议进行皮肤检查。该信息不是说服药者一定会发生皮肤癌，也不是自行停药理由；发现新生、变化、出血或不愈合的皮损应联系专业人员。", "en": "The dated FDA label advises sun protection and regular skin checks as clinically directed during long-term use. This does not mean a user will develop skin cancer and is not a reason to stop treatment independently; seek professional assessment for a new, changing, bleeding or non-healing skin lesion." } ], "source": { "id": "src_112ef053c229398f", "label": "FDA：MICROZIDE（hydrochlorothiazide）12.5 mg 胶囊美国处方信息（2020-08 修订；标签注明可能不是最新版本）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020504s026lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "氢氯噻嗪怎样起作用：减少钠和氯的重吸收，让更多水随尿排出", "en": "How hydrochlorothiazide works: reducing sodium and chloride reabsorption so more water leaves in urine" }, "summary": { "zh": "FDA 标签说明氢氯噻嗪阻断一部分钠和氯离子的重吸收，从而增加随尿排出的钠和水；同时可能增加钾、氢和氯的丢失，并影响钙和尿酸的排泄。这解释了为什么不能只盯着血压，还要结合症状、肾功能和电解质监测。", "en": "The FDA label explains that hydrochlorothiazide blocks part of sodium and chloride reabsorption, increasing sodium and water excretion. It may also increase loss of potassium, hydrogen and chloride and affect calcium and uric-acid excretion. This is why blood pressure alone is not enough: symptoms, kidney function and electrolyte monitoring also matter." }, "checks": [ { "zh": "它不是“普通排水胶囊”，也不是看到水肿、体重或血压变化就能自行多吃或补吃的工具。过度利尿可造成脱水、低血压和电解质紊乱。", "en": "It is not an ordinary water-removal capsule or a tool to increase or repeat yourself because swelling, weight or blood pressure changes. Excessive diuresis can cause dehydration, low blood pressure and electrolyte disturbance." }, { "zh": "氢氯噻嗪片、MICROZIDE 胶囊以及含氢氯噻嗪的复方片是不同产品；共同成分不表示可以按毫克数自行叠加、轮换、拆分或替代。", "en": "Hydrochlorothiazide tablets, MICROZIDE capsules and combination tablets containing hydrochlorothiazide are different products. A shared ingredient does not permit self-combination, rotation, splitting or substitution by milligram numbers." }, { "zh": "网页解释药理路径与说明书风险，不替个人决定目标血压、服用时刻、粒数、漏服补服、饮水或盐摄入、化验频率、停药或换药。", "en": "The site explains the pharmacologic pathway and label risks. It does not decide an individual's target blood pressure, timing, capsule count, missed-use action, fluid or salt intake, laboratory frequency, stopping or switching." } ], "source": { "id": "src_112ef053c229398f", "label": "FDA：MICROZIDE（hydrochlorothiazide）12.5 mg 胶囊美国处方信息（2020-08 修订；标签注明可能不是最新版本）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020504s026lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "MICROZIDE", "generic": "氢氯噻嗪胶囊", "dosageFormClass": "氢氯噻嗪 12.5 mg 口服胶囊；不是氢氯噻嗪片，也不是已经含氢氯噻嗪的复方片" }, "labelSource": { "id": "src_112ef053c229398f", "label": "FDA：MICROZIDE（hydrochlorothiazide）12.5 mg 胶囊美国处方信息（2020-08 修订；标签注明可能不是最新版本）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020504s026lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "productRoutes": [ { "source": { "id": "src_112ef053c229398f", "label": "FDA：MICROZIDE（hydrochlorothiazide）12.5 mg 胶囊美国处方信息（2020-08 修订；标签注明可能不是最新版本）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020504s026lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-08-29", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_10e511bf83430e3b", "label": "FDA Orange Book 当前数据：MICROZIDE（hydrochlorothiazide）NDA 020504，12.5 mg 口服胶囊；处方药 RLD 与 RS", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-08-29", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_46382e935f7dacef", "label": "DailyMed（NLM）：MICROZIDE 12.5 mg、NDC 52544-622-01、100 粒瓶装历史标签（2011-10 修订；营销结束 2020-08-31）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=afbefaff-97c4-4f84-b989-1595f882a885", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_archive", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-29", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-08-29", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "MICROZIDE 是氢氯噻嗪 12.5 mg 口服胶囊。它帮助肾脏排出更多钠和水，也可能影响钾、钠、镁、尿酸、血糖与血压。很多复方降压药已经含有氢氯噻嗪；只看品牌名再加一盒单方药可能重复成分。网页先帮助核对完整成分和准确药盒，不提供个人粒数、补服、加减量或换药方案。", "history": "FDA Orange Book 当前数据将 MICROZIDE NDA 020504 的 12.5 mg 口服胶囊列为处方 RLD 与 RS，原始批准日期为 1996-12-27。FDA 2020 年标签是本页的有日期说明书阅读来源，并明确提示它可能不是最新版本；DailyMed 2011 年标签中的 NDC 52544-622-01 已记录营销于 2020-08-31 结束，因此其图片只作历史包装核对。", "sourceDocuments": [ { "id": "src_10e511bf83430e3b", "label": "FDA Orange Book 当前数据：MICROZIDE（hydrochlorothiazide）NDA 020504，12.5 mg 口服胶囊；处方药 RLD 与 RS", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, { "id": "src_112ef053c229398f", "label": "FDA：MICROZIDE（hydrochlorothiazide）12.5 mg 胶囊美国处方信息（2020-08 修订；标签注明可能不是最新版本）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020504s026lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, { "id": "src_46382e935f7dacef", "label": "DailyMed（NLM）：MICROZIDE 12.5 mg、NDC 52544-622-01、100 粒瓶装历史标签（2011-10 修订；营销结束 2020-08-31）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=afbefaff-97c4-4f84-b989-1595f882a885", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_archive", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } ], "applicationNumber": "FDA NDA 020504（MICROZIDE / hydrochlorothiazide 12.5 mg oral capsule）", "approvalTimeline": [ { "date": "1996-12-27", "title": { "zh": "FDA 原始批准", "en": "FDA original approval" }, "detail": { "zh": "Orange Book 当前数据将 MICROZIDE 12.5 mg 口服胶囊与 NDA 020504、RLD/RS 身份相连。", "en": "Current Orange Book data link the MICROZIDE 12.5 mg oral capsule to NDA 020504 and RLD/RS identity." }, "source": { "id": "src_10e511bf83430e3b", "label": "FDA Orange Book 当前数据：MICROZIDE（hydrochlorothiazide）NDA 020504，12.5 mg 口服胶囊；处方药 RLD 与 RS", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } }, { "date": "2020-08", "title": { "zh": "FDA 有日期处方信息修订", "en": "Dated FDA prescribing-information revision" }, "detail": { "zh": "该文件用于本页说明书放大阅读；文件本身提示可能不是最新批准标签，因此不得单独当作当前包装或全部现行信息。", "en": "This document supports enlarged label reading here; it says it may not be the latest approved label and therefore does not alone establish a current pack or every current statement." }, "source": { "id": "src_112ef053c229398f", "label": "FDA：MICROZIDE（hydrochlorothiazide）12.5 mg 胶囊美国处方信息（2020-08 修订；标签注明可能不是最新版本）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020504s026lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } }, { "date": "2020-08-31", "title": { "zh": "历史 DailyMed NDC 营销结束", "en": "Historical DailyMed NDC marketing end" }, "detail": { "zh": "NDC 52544-622-01 的 100 粒瓶装图片自此只作历史包装核对。", "en": "The NDC 52544-622-01 100-capsule bottle image is used only as a historical pack reference after this date." }, "source": { "id": "src_46382e935f7dacef", "label": "DailyMed（NLM）：MICROZIDE 12.5 mg、NDC 52544-622-01、100 粒瓶装历史标签（2011-10 修订；营销结束 2020-08-31）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=afbefaff-97c4-4f84-b989-1595f882a885", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_archive", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "Orange Book 当前列示处方 RLD/RS；当前准确 NDC/包装未建立", "en": "Currently listed by the Orange Book as prescription RLD/RS; exact current NDC/pack not established" }, "detail": { "zh": "页面保留产品身份，同时把 2020 标签和旧包装标成有日期资料；不证明任何药店库存或购买资格。", "en": "The page retains product identity while marking the 2020 label and old pack as dated material; it does not establish pharmacy stock or purchasing eligibility." } }, { "market": { "zh": "中国大陆及其他市场", "en": "Mainland China and other markets" }, "status": { "zh": "待逐项建立现行市场记录", "en": "Current market record not established" }, "detail": { "zh": "不从美国名称、通用名或 12.5 mg 数字推定当地批准、商品名、包装、原研/仿制关系、供应或可替代性。", "en": "No local approval, trade name, pack, originator/generic relationship, supply or interchangeability is inferred from the U.S. name, generic or 12.5 mg number." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "为什么要特别检查复方药？", "en": "Why should combination medicines be checked carefully?" }, "answer": { "zh": "因为氢氯噻嗪可能已经作为第二或第三种成分写在复方药盒上。再加 MICROZIDE 可能重复同一成分，但是否重复、是否有意安排只能由准确处方和完整药单判断，网页不能替你停掉任何一盒。", "en": "Hydrochlorothiazide may already be listed as the second or third ingredient on a combination pack. Adding MICROZIDE may duplicate that ingredient, but only the exact prescriptions and full medicine list can show whether this is duplication or intentional; the website cannot tell you to stop a pack." } }, { "question": { "zh": "12.5 mg 是一次必须吃一粒吗？", "en": "Does 12.5 mg mean one capsule must be taken each time?" }, "answer": { "zh": "不是。12.5 mg 是每粒标签量，用于识别产品。个人粒数、频次、漏服处理和调整必须按自己的处方、病情、肾功能、电解质和其他药物由专业人员判断。", "en": "No. The 12.5 mg is the labelled amount per capsule for product identification. An individual's capsule count, frequency, missed-use action and adjustment require professional review of the prescription, condition, kidney function, electrolytes and other medicines." } }, { "question": { "zh": "网上的蓝绿色胶囊图就是现在买到的外观吗？", "en": "Is the teal capsule image the appearance of a pack available now?" }, "answer": { "zh": "不能这样理解。本站图片对应 2011 年 DailyMed 历史标签中的 NDC 52544-622-01，营销已于 2020 年结束。当前实际药盒应按其完整文字、NDC/批准信息和目标市场官方记录另行核对。", "en": "No. The image corresponds to NDC 52544-622-01 in a 2011 DailyMed historical label whose marketing ended in 2020. A current pack must be checked separately using all visible text, NDC or approval information and the target market's official record." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "how-to-read-a-drug-label", "dosage-forms-are-part-of-medicine-identity" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/microzide/", "en": "https://origindrug.com/en/drugs/microzide/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "hyzaar", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-29", "status": "published_traceable_archive" }, "names": { "brand": "HYZAAR", "generic": "氯沙坦钾/氢氯噻嗪片", "aliases": [ "Hyzaar", "losartan hydrochlorothiazide", "losartan/HCTZ", "氯沙坦氢氯噻嗪", "氯沙坦钾氢氯噻嗪片", "losartan potassium and hydrochlorothiazide", "氯沙坦钾/氢氯噻嗪", "氯沙坦氢氯噻嗪片", "NDA 020387", "78206-139-01", "78206-140-01", "78206-141-01" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "心血管", "sourceArchiveMarket": "美国：DailyMed 当前 HYZAAR 标签列示氯沙坦钾/氢氯噻嗪薄膜衣口服片、三个规格及 30 片和 90 片瓶装；本档案精确展示三个 30 片瓶装面板。FDA Orange Book 当前数据将 NDA 020387 的三个规格列为处方 RLD。页面不由此推定其他市场的名称、包装、供应、可售资格或可替代性。", "dosageFormClass": "氯沙坦钾/氢氯噻嗪固定两成分薄膜衣口服片：50/12.5 mg、100/12.5 mg、100/25 mg；每组两个数字属于同一片内两种成分", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "1995", "archiveSponsorText": "Organon LLC（当前 DailyMed 标签与 FDA Orange Book 数据所列主体）" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [ "COZAAR", "losartan potassium tablet", "MICROZIDE", "hydrochlorothiazide capsule", "AVALIDE", "EXFORGE HCT" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-hyzaar-losartan-hctz-tablet-50-12-5mg-30-bottle-ndc-7820613901", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（处方信息 2025-06 修订；2026-08-29 核验）", "en": "Current U.S. DailyMed public label (prescribing information revised Jun 2025; verified 29 Aug 2026)" }, "dosageForm": { "zh": "HYZAAR 氯沙坦钾/氢氯噻嗪薄膜衣口服片", "en": "HYZAAR losartan potassium/hydrochlorothiazide film-coated oral tablet" }, "route": { "zh": "口服（固定两成分产品身份字段）", "en": "oral (fixed two-ingredient product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 78206-139-01", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片氯沙坦钾 50 mg＋氢氯噻嗪 12.5 mg；30 片瓶装", "en": "Losartan potassium 50 mg plus hydrochlorothiazide 12.5 mg per tablet; 30-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=hyzaar-03.jpg&setid=4116ccde-2e23-45f4-b12f-6337df877744&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "氯沙坦钾", "en": "losartan potassium" }, "value": 50, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片第一成分标签量；不是个人片数或换算指令", "en": "labelled amount of the first ingredient per tablet; not an individual tablet count or conversion instruction" } }, { "ingredient": { "zh": "氢氯噻嗪", "en": "hydrochlorothiazide" }, "value": 12.5, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片第二成分标签量；不是加用利尿药或换算指令", "en": "labelled amount of the second ingredient per tablet; not an instruction to add a diuretic or convert products" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-29", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 30, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "黄色", "en": "yellow" }, "shape": { "zh": "椭圆形薄膜衣片，约 11 mm；无刻痕", "en": "oval film-coated tablet, about 11 mm; unscored" }, "imprint": "717", "scoreStatus": "unscored_do_not_split", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_aa6592fa9928e26e", "label": "DailyMed（NLM）：HYZAAR 50/12.5 mg、NDC 78206-139-01、30 片瓶装当前美国标签面板", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=4116ccde-2e23-45f4-b12f-6337df877744", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-hyzaar-losartan-hctz-tablet-100-12-5mg-30-bottle-ndc-7820614001", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（处方信息 2025-06 修订；2026-08-29 核验）", "en": "Current U.S. DailyMed public label (prescribing information revised Jun 2025; verified 29 Aug 2026)" }, "dosageForm": { "zh": "HYZAAR 氯沙坦钾/氢氯噻嗪薄膜衣口服片", "en": "HYZAAR losartan potassium/hydrochlorothiazide film-coated oral tablet" }, "route": { "zh": "口服（固定两成分产品身份字段）", "en": "oral (fixed two-ingredient product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 78206-140-01", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片氯沙坦钾 100 mg＋氢氯噻嗪 12.5 mg；30 片瓶装", "en": "Losartan potassium 100 mg plus hydrochlorothiazide 12.5 mg per tablet; 30-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=hyzaar-04.jpg&setid=4116ccde-2e23-45f4-b12f-6337df877744&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "氯沙坦钾", "en": "losartan potassium" }, "value": 100, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片第一成分标签量；不是个人片数或换算指令", "en": "labelled amount of the first ingredient per tablet; not an individual tablet count or conversion instruction" } }, { "ingredient": { "zh": "氢氯噻嗪", "en": "hydrochlorothiazide" }, "value": 12.5, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片第二成分标签量；不是加用利尿药或换算指令", "en": "labelled amount of the second ingredient per tablet; not an instruction to add a diuretic or convert products" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-29", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 30, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "白色", "en": "white" }, "shape": { "zh": "椭圆形薄膜衣片，约 13 mm；无刻痕", "en": "oval film-coated tablet, about 13 mm; unscored" }, "imprint": "745", "scoreStatus": "unscored_do_not_split", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_aa6592fa9928e26e", "label": "DailyMed（NLM）：HYZAAR 100/12.5 mg、NDC 78206-140-01、30 片瓶装当前美国标签面板", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=4116ccde-2e23-45f4-b12f-6337df877744", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-hyzaar-losartan-hctz-tablet-100-25mg-30-bottle-ndc-7820614101", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（处方信息 2025-06 修订；2026-08-29 核验）", "en": "Current U.S. DailyMed public label (prescribing information revised Jun 2025; verified 29 Aug 2026)" }, "dosageForm": { "zh": "HYZAAR 氯沙坦钾/氢氯噻嗪薄膜衣口服片", "en": "HYZAAR losartan potassium/hydrochlorothiazide film-coated oral tablet" }, "route": { "zh": "口服（固定两成分产品身份字段）", "en": "oral (fixed two-ingredient product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 78206-141-01", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片氯沙坦钾 100 mg＋氢氯噻嗪 25 mg；30 片瓶装", "en": "Losartan potassium 100 mg plus hydrochlorothiazide 25 mg per tablet; 30-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=hyzaar-05.jpg&setid=4116ccde-2e23-45f4-b12f-6337df877744&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "氯沙坦钾", "en": "losartan potassium" }, "value": 100, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片第一成分标签量；不是个人片数或换算指令", "en": "labelled amount of the first ingredient per tablet; not an individual tablet count or conversion instruction" } }, { "ingredient": { "zh": "氢氯噻嗪", "en": "hydrochlorothiazide" }, "value": 25, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片第二成分标签量；不是加用利尿药或换算指令", "en": "labelled amount of the second ingredient per tablet; not an instruction to add a diuretic or convert products" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-29", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 30, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "浅黄色", "en": "light yellow" }, "shape": { "zh": "椭圆形薄膜衣片，约 16 mm；无刻痕", "en": "oval film-coated tablet, about 16 mm; unscored" }, "imprint": "747", "scoreStatus": "unscored_do_not_split", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_aa6592fa9928e26e", "label": "DailyMed（NLM）：HYZAAR 100/25 mg、NDC 78206-141-01、30 片瓶装当前美国标签面板", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=4116ccde-2e23-45f4-b12f-6337df877744", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-hyzaar-losartan-hctz-tablet-50-12-5mg-30-bottle-ndc-7820613901", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=hyzaar-03.jpg&setid=4116ccde-2e23-45f4-b12f-6337df877744&type=img", "alt": { "zh": "DailyMed 当前 HYZAAR 50/12.5 mg、NDC 78206-139-01、30 片瓶装标签面板", "en": "Current DailyMed HYZAAR 50/12.5 mg, NDC 78206-139-01, 30-tablet bottle label panel" }, "archiveMarket": "美国", "labelVersion": "DailyMed 当前美国公开标签（处方信息 2025-06 修订）", "presentation": "HYZAAR 氯沙坦钾 50 mg/氢氯噻嗪 12.5 mg 每片，NDC 78206-139-01，30 片瓶装。", "notice": "此图只对应当前 DailyMed 标签中的 HYZAAR 50/12.5 mg、NDC 78206-139-01、30 片瓶装面板；不能代表 100/12.5 mg、100/25 mg、90 片瓶装、其他市场、仿制药或复方同类产品，也不用于鉴定真伪或决定个人片数。", "source": { "id": "src_aa6592fa9928e26e", "label": "DailyMed（NLM）：HYZAAR 50/12.5 mg、NDC 78206-139-01、30 片瓶装当前美国标签面板", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=4116ccde-2e23-45f4-b12f-6337df877744", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "HYZAAR 说明书放大阅读：斜线两边是两种成分，不是分片或加量公式", "en": "HYZAAR label reading: the two numbers are two ingredients, not a splitting or dose formula" }, "summary": { "zh": "HYZAAR 每片固定含氯沙坦钾和氢氯噻嗪。比如 50/12.5 mg 表示同一片内分别含 50 mg 与 12.5 mg；不能把它理解成半片、两片、总量 62.5 mg 后与另一种药直接换算。", "en": "Each HYZAAR tablet contains fixed amounts of losartan potassium and hydrochlorothiazide. For example, 50/12.5 mg means 50 mg and 12.5 mg of the two ingredients in one tablet; it is not a half-tablet cue, a two-tablet cue or a 62.5 mg total that can be directly converted to another product." }, "checks": [ { "zh": "逐盒核对有效成分。COZAAR 是单方氯沙坦，MICROZIDE 是单方氢氯噻嗪；AVALIDE 与 EXFORGE HCT 也含氢氯噻嗪。若它们与 HYZAAR 同时出现在药单，不要自行删掉或加上任何一盒，应让药师或开方团队依据完整处方判断是否有意联用或重复。", "en": "Check the active ingredients on every pack. COZAAR is losartan alone, MICROZIDE is hydrochlorothiazide alone, and AVALIDE and EXFORGE HCT also contain hydrochlorothiazide. If any appear together with HYZAAR, do not remove or add a pack yourself; a pharmacist or prescriber must use the complete prescriptions to determine whether use is intentional or duplicative." }, { "zh": "头晕、晕厥、明显乏力、口渴、尿量显著减少、持续呕吐或腹泻、肌肉无力或抽筋、心跳异常，可能与血压、水分、肾功能或电解质变化有关。严重、突然或伴意识异常时应使用当地急救服务。", "en": "Dizziness, fainting, marked weakness, thirst, clearly reduced urine, persistent vomiting or diarrhoea, muscle weakness or cramps, or an abnormal heartbeat may accompany changes in blood pressure, fluid balance, kidney function or electrolytes. Use local emergency services for severe or sudden symptoms or altered consciousness." }, { "zh": "不要自行使用含钾补充剂或含钾代盐。锂盐、非甾体抗炎止痛药、其他影响肾素-血管紧张素系统的药物，以及其他利尿或降压药，都需要结合完整药单核对。", "en": "Do not use potassium supplements or potassium-containing salt substitutes without professional review. Lithium, NSAID pain medicines, other medicines affecting the renin-angiotensin system and other diuretic or blood-pressure medicines all require review against the complete medicine list." }, { "zh": "突然眼痛、视力快速下降或明显视物模糊需要及时就医；面唇舌喉肿胀、呼吸困难或晕厥应使用当地急救服务。", "en": "Sudden eye pain, rapidly reduced vision or marked blurred vision requires prompt medical assessment. Swelling of the face, lips, tongue or throat, breathing difficulty or fainting requires local emergency services." }, { "zh": "标签有胎儿毒性黑框警示。已经怀孕、可能怀孕或计划怀孕者应立即联系开方团队核对，不要等待网页判断，也不要用网页自行安排停换药。", "en": "The label carries a boxed warning for fetal toxicity. Anyone who is pregnant, may be pregnant or plans pregnancy should contact the prescribing team promptly; do not wait for a website decision or use the site to arrange stopping or switching." }, { "zh": "标签提醒使用氢氯噻嗪者做好防晒并按临床建议进行皮肤检查；这不是说一定会发生皮肤癌，也不是自行停药理由。", "en": "The label advises sun protection and skin screening as clinically directed for hydrochlorothiazide users. This does not mean skin cancer will occur and is not a reason to stop treatment independently." } ], "source": { "id": "src_aa6592fa9928e26e", "label": "DailyMed（NLM）：HYZAAR 氯沙坦钾/氢氯噻嗪当前美国公开标签（Organon；处方信息 2025-06 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=4116ccde-2e23-45f4-b12f-6337df877744", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "两种成分怎样协同：一项阻断血管紧张素 II 信号，一项帮助排出钠和水", "en": "How the two ingredients work together: one blocks angiotensin II signalling and one increases sodium and water excretion" }, "summary": { "zh": "当前标签说明：氯沙坦及其活性代谢物阻断血管紧张素 II 与 AT1 受体结合，从而减少血管收缩和醛固酮相关作用；氢氯噻嗪减少一部分钠和氯的重吸收，使更多钠和水随尿排出。两条路径放在同一片中，不代表网页能按血压数字拆分或重组个人方案。", "en": "The current label explains that losartan and its active metabolite block angiotensin II binding at the AT1 receptor, reducing vasoconstrictor and aldosterone-related effects, while hydrochlorothiazide reduces sodium and chloride reabsorption so more sodium and water leave in urine. Combining both paths in one tablet does not let the site split or rebuild an individual's regimen from a blood-pressure number." }, "checks": [ { "zh": "氯沙坦成分可能影响钾和肾功能，氢氯噻嗪成分可能造成低钾、低钠、低镁，也会影响尿酸、血糖、血脂和钙。不能只看“降压”两个字忽略化验、症状和完整药单。", "en": "The losartan component can affect potassium and kidney function; the hydrochlorothiazide component can cause low potassium, sodium or magnesium and affect urate, glucose, lipids and calcium. The word 'blood pressure' alone must not replace symptoms, laboratory review and the complete medicine list." }, { "zh": "50/12.5、100/12.5 和 100/25 是三种完整产品身份。不同 mg 组合、颜色、印字和 NDC 不能由网页转换成个人加量、减量、掰片、补服或交替使用。", "en": "50/12.5, 100/12.5 and 100/25 are three complete product identities. Different milligram pairs, colours, imprints and NDCs cannot be converted by the site into an individual increase, decrease, split, make-up use or alternation plan." }, { "zh": "老人或存在肾功能、肝功能、糖尿病、痛风、水分不足等情况时，更需要专业人员结合实际药盒和监测结果复核；网页不根据年龄或化验自动生成方案。", "en": "Older adults and people with kidney or liver impairment, diabetes, gout or volume depletion particularly need professional review using the actual packs and monitoring results; the site does not generate a regimen from age or laboratory values." } ], "source": { "id": "src_aa6592fa9928e26e", "label": "DailyMed（NLM）：HYZAAR 氯沙坦钾/氢氯噻嗪当前美国公开标签（Organon；处方信息 2025-06 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=4116ccde-2e23-45f4-b12f-6337df877744", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "HYZAAR", "generic": "氯沙坦钾/氢氯噻嗪片", "dosageFormClass": "氯沙坦钾/氢氯噻嗪固定两成分薄膜衣口服片：50/12.5 mg、100/12.5 mg、100/25 mg；每组两个数字属于同一片内两种成分" }, "labelSource": { "id": "src_aa6592fa9928e26e", "label": "DailyMed（NLM）：HYZAAR 氯沙坦钾/氢氯噻嗪当前美国公开标签（Organon；处方信息 2025-06 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=4116ccde-2e23-45f4-b12f-6337df877744", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "productRoutes": [ { "source": { "id": "src_aa6592fa9928e26e", "label": "DailyMed（NLM）：HYZAAR 氯沙坦钾/氢氯噻嗪当前美国公开标签（Organon；处方信息 2025-06 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=4116ccde-2e23-45f4-b12f-6337df877744", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-29", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_10e511bf83430e3b", "label": "FDA Orange Book 当前数据：HYZAAR，NDA 020387，三个口服片规格均为处方 RLD", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-08-29", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-29", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "HYZAAR 一片同时含氯沙坦钾和氢氯噻嗪。药盒上的 50/12.5、100/12.5 或 100/25 不是“吃半片”的算式，而是每片两种成分各有多少毫克。若药单还有 COZAAR、MICROZIDE，或 AVALIDE、EXFORGE HCT 等其他含氢氯噻嗪产品，要先让药师或开方团队核对是否重复；不要自行加药、停药或轮换。", "history": "FDA Orange Book 当前数据记录 HYZAAR NDA 020387：50/12.5 mg 于 1995-04-28 获批，100/25 mg 于 1998-11-10 获批，100/12.5 mg 于 2005-10-20 获批；三个规格均列为处方 RLD。当前 DailyMed 标签的三个 30 片瓶装面板分别对应 NDC 78206-139-01、78206-140-01 和 78206-141-01。", "sourceDocuments": [ { "id": "src_aa6592fa9928e26e", "label": "DailyMed（NLM）：HYZAAR 氯沙坦钾/氢氯噻嗪当前美国公开标签（Organon；处方信息 2025-06 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=4116ccde-2e23-45f4-b12f-6337df877744", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, { "id": "src_10e511bf83430e3b", "label": "FDA Orange Book 当前数据：HYZAAR，NDA 020387，三个口服片规格均为处方 RLD", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } ], "applicationNumber": "FDA NDA 020387（HYZAAR / losartan potassium and hydrochlorothiazide oral tablets）", "approvalTimeline": [ { "date": "1995-04-28", "title": { "zh": "50/12.5 mg 原始批准", "en": "Original approval of 50/12.5 mg" }, "detail": { "zh": "Orange Book 当前数据将该规格列为 NDA 020387 产品 001、处方 RLD。", "en": "Current Orange Book data list this strength as NDA 020387 product 001 and a prescription RLD." }, "source": { "id": "src_10e511bf83430e3b", "label": "FDA Orange Book 当前数据：HYZAAR，NDA 020387，三个口服片规格均为处方 RLD", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } }, { "date": "1998-11-10", "title": { "zh": "100/25 mg 获批", "en": "Approval of 100/25 mg" }, "detail": { "zh": "Orange Book 当前数据将该规格列为产品 002、处方 RLD。", "en": "Current Orange Book data list this strength as product 002 and a prescription RLD." }, "source": { "id": "src_10e511bf83430e3b", "label": "FDA Orange Book 当前数据：HYZAAR，NDA 020387，三个口服片规格均为处方 RLD", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } }, { "date": "2005-10-20", "title": { "zh": "100/12.5 mg 获批", "en": "Approval of 100/12.5 mg" }, "detail": { "zh": "Orange Book 当前数据将该规格列为产品 003、处方 RLD。", "en": "Current Orange Book data list this strength as product 003 and a prescription RLD." }, "source": { "id": "src_10e511bf83430e3b", "label": "FDA Orange Book 当前数据：HYZAAR，NDA 020387，三个口服片规格均为处方 RLD", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } }, { "date": "2025-06", "title": { "zh": "当前公开处方信息修订", "en": "Current public prescribing-information revision" }, "detail": { "zh": "DailyMed 当前页面保留三个规格、外观、包装、黑框警示及药物相互作用等说明书入口。", "en": "The current DailyMed page retains the three strengths, appearances, packs, boxed warning, interactions and other label-reading routes." }, "source": { "id": "src_aa6592fa9928e26e", "label": "DailyMed（NLM）：HYZAAR 氯沙坦钾/氢氯噻嗪当前美国公开标签（Organon；处方信息 2025-06 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=4116ccde-2e23-45f4-b12f-6337df877744", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "当前 DailyMed 品牌标签；Orange Book 三个规格均列为处方 RLD", "en": "Current DailyMed brand label; all three strengths are listed as prescription RLD products in the Orange Book" }, "detail": { "zh": "本页展示三个 30 片瓶装面板；不由标签推断特定药店库存或购买资格。", "en": "This page displays three 30-tablet bottle panels; the label does not establish stock at a particular pharmacy or purchasing eligibility." } }, { "market": { "zh": "中国大陆及其他市场", "en": "Mainland China and other markets" }, "status": { "zh": "待逐项建立现行市场记录", "en": "Current market record not established" }, "detail": { "zh": "不从美国品牌、共同成分或 mg 数字推定当地批准、商品名、包装、供应或可替代性。", "en": "No local approval, trade name, pack, supply or interchangeability is inferred from the U.S. brand, shared ingredients or milligram numbers." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "50/12.5 mg 是不是把药片掰一半？", "en": "Does 50/12.5 mg mean splitting the tablet in half?" }, "answer": { "zh": "不是。它表示同一片内有氯沙坦钾 50 mg 和氢氯噻嗪 12.5 mg。标签列示这些片剂无刻痕；网页也不会把 mg 组合转换为掰片或个人片数。", "en": "No. It means one tablet contains losartan potassium 50 mg and hydrochlorothiazide 12.5 mg. The label lists these tablets as unscored, and the site does not convert the milligram pair into splitting or an individual tablet count." } }, { "question": { "zh": "已经吃 HYZAAR，还能再吃 COZAAR 或 MICROZIDE 吗？", "en": "Can COZAAR or MICROZIDE be taken in addition to HYZAAR?" }, "answer": { "zh": "网页不能替个人决定。HYZAAR 已含氯沙坦和氢氯噻嗪，再出现单方同成分可能是重复，也可能是专业人员有意安排；只有准确处方、实际药盒和完整药单才能判断。不要自行加上或停掉任何一盒。", "en": "The website cannot decide for an individual. HYZAAR already contains losartan and hydrochlorothiazide, so an additional single-ingredient product may be duplicative or may be intentionally prescribed; only the exact prescriptions, packs and complete medicine list can establish that. Do not add or stop a pack yourself." } }, { "question": { "zh": "三种 HYZAAR 颜色不同，能按颜色互相替换吗？", "en": "Can the three HYZAAR products be substituted by colour?" }, "answer": { "zh": "不能。黄色 717、白色 745、浅黄色 747 分别对应不同的两成分强度与 NDC；颜色只作辅助外观线索，不能证明真伪、适用性或可替代性。", "en": "No. Yellow 717, white 745 and light-yellow 747 correspond to different two-ingredient strengths and NDCs. Colour is only an appearance clue and does not establish authenticity, suitability or interchangeability." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "how-to-read-a-drug-label", "dosage-forms-are-part-of-medicine-identity" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/hyzaar/", "en": "https://origindrug.com/en/drugs/hyzaar/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "diovan-hct", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-29", "status": "published_traceable_archive" }, "names": { "brand": "DIOVAN HCT", "generic": "缬沙坦/氢氯噻嗪片", "aliases": [ "Diovan HCT", "valsartan hydrochlorothiazide", "valsartan/HCTZ", "缬沙坦氢氯噻嗪", "缬沙坦氢氯噻嗪片", "valsartan and hydrochlorothiazide", "NDA 020818", "0078-0314-34", "0078-0315-34", "0078-0383-34", "0078-0471-34", "0078-0472-34" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "心血管", "sourceArchiveMarket": "美国：DailyMed 当前 DIOVAN HCT 标签列示缬沙坦/氢氯噻嗪薄膜衣口服片、五个规格与五个 90 片瓶装面板；FDA Orange Book 当前数据将 NDA 020818 的五个规格列为处方 RLD，其中 320/25 mg 还列为 RS。页面不由此推定其他市场的名称、包装、供应、可售资格或可替代性。", "dosageFormClass": "缬沙坦/氢氯噻嗪固定两成分薄膜衣口服片：80/12.5 mg、160/12.5 mg、160/25 mg、320/12.5 mg、320/25 mg；每组两个数字属于同一片内两种成分", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "1998", "archiveSponsorText": "Novartis Pharmaceuticals Corporation（当前 DailyMed 标签与 FDA Orange Book 数据所列主体）" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [ "valsartan tablet", "MICROZIDE", "hydrochlorothiazide capsule", "EXFORGE", "EXFORGE HCT", "ENTRESTO", "HYZAAR", "AVALIDE" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-diovan-hct-valsartan-hctz-tablet-80-12-5mg-90-bottle-ndc-0078031434", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（SPL v34，2026-02-13 生效；2026-08-29 核验）", "en": "Current U.S. DailyMed public label (SPL v34, effective 13 Feb 2026; verified 29 Aug 2026)" }, "dosageForm": { "zh": "DIOVAN HCT 缬沙坦/氢氯噻嗪薄膜衣口服片", "en": "DIOVAN HCT valsartan/hydrochlorothiazide film-coated oral tablet" }, "route": { "zh": "口服（固定两成分产品身份字段）", "en": "oral (fixed two-ingredient product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 0078-0314-34", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片缬沙坦 80 mg＋氢氯噻嗪 12.5 mg；90 片瓶装", "en": "Valsartan 80 mg plus hydrochlorothiazide 12.5 mg per tablet; 90-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=diovan-hct-07.jpg&setid=d76a0419-05ee-437e-884c-65807aea9569", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "缬沙坦", "en": "valsartan" }, "value": 80, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片第一成分标签量；不是个人片数或换算指令", "en": "labelled amount of the first ingredient per tablet; not an individual tablet count or conversion instruction" } }, { "ingredient": { "zh": "氢氯噻嗪", "en": "hydrochlorothiazide" }, "value": 12.5, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片第二成分标签量；不是加用利尿药或换算指令", "en": "labelled amount of the second ingredient per tablet; not an instruction to add a diuretic or convert products" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 90, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-29", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 90, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "浅橙色", "en": "light orange" }, "shape": { "zh": "椭圆形薄膜衣片，约 10 mm；无刻痕", "en": "ovaloid film-coated tablet, about 10 mm; unscored" }, "imprint": "CG / HGH", "scoreStatus": "unscored_do_not_split", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_ee6d762c05b73cb0", "label": "DailyMed（NLM）：DIOVAN HCT 80/12.5 mg、NDC 0078-0314-34、90 片瓶装当前美国标签面板", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d76a0419-05ee-437e-884c-65807aea9569", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-diovan-hct-valsartan-hctz-tablet-160-12-5mg-90-bottle-ndc-0078031534", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（SPL v34，2026-02-13 生效；2026-08-29 核验）", "en": "Current U.S. DailyMed public label (SPL v34, effective 13 Feb 2026; verified 29 Aug 2026)" }, "dosageForm": { "zh": "DIOVAN HCT 缬沙坦/氢氯噻嗪薄膜衣口服片", "en": "DIOVAN HCT valsartan/hydrochlorothiazide film-coated oral tablet" }, "route": { "zh": "口服（固定两成分产品身份字段）", "en": "oral (fixed two-ingredient product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 0078-0315-34", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片缬沙坦 160 mg＋氢氯噻嗪 12.5 mg；90 片瓶装", "en": "Valsartan 160 mg plus hydrochlorothiazide 12.5 mg per tablet; 90-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=diovan-hct-08.jpg&setid=d76a0419-05ee-437e-884c-65807aea9569", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "缬沙坦", "en": "valsartan" }, "value": 160, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片第一成分标签量；不是个人片数或换算指令", "en": "labelled amount of the first ingredient per tablet; not an individual tablet count or conversion instruction" } }, { "ingredient": { "zh": "氢氯噻嗪", "en": "hydrochlorothiazide" }, "value": 12.5, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片第二成分标签量；不是加用利尿药或换算指令", "en": "labelled amount of the second ingredient per tablet; not an instruction to add a diuretic or convert products" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 90, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-29", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 90, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "深红色", "en": "dark red" }, "shape": { "zh": "椭圆形薄膜衣片，约 15 mm；无刻痕", "en": "ovaloid film-coated tablet, about 15 mm; unscored" }, "imprint": "CG / HHH", "scoreStatus": "unscored_do_not_split", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_ee6d762c05b73cb0", "label": "DailyMed（NLM）：DIOVAN HCT 160/12.5 mg、NDC 0078-0315-34、90 片瓶装当前美国标签面板", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d76a0419-05ee-437e-884c-65807aea9569", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-diovan-hct-valsartan-hctz-tablet-160-25mg-90-bottle-ndc-0078038334", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（SPL v34，2026-02-13 生效；2026-08-29 核验）", "en": "Current U.S. DailyMed public label (SPL v34, effective 13 Feb 2026; verified 29 Aug 2026)" }, "dosageForm": { "zh": "DIOVAN HCT 缬沙坦/氢氯噻嗪薄膜衣口服片", "en": "DIOVAN HCT valsartan/hydrochlorothiazide film-coated oral tablet" }, "route": { "zh": "口服（固定两成分产品身份字段）", "en": "oral (fixed two-ingredient product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 0078-0383-34", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片缬沙坦 160 mg＋氢氯噻嗪 25 mg；90 片瓶装", "en": "Valsartan 160 mg plus hydrochlorothiazide 25 mg per tablet; 90-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=diovan-hct-09.jpg&setid=d76a0419-05ee-437e-884c-65807aea9569", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "缬沙坦", "en": "valsartan" }, "value": 160, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片第一成分标签量；不是个人片数或换算指令", "en": "labelled amount of the first ingredient per tablet; not an individual tablet count or conversion instruction" } }, { "ingredient": { "zh": "氢氯噻嗪", "en": "hydrochlorothiazide" }, "value": 25, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片第二成分标签量；不是加用利尿药或换算指令", "en": "labelled amount of the second ingredient per tablet; not an instruction to add a diuretic or convert products" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 90, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-29", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 90, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "棕橙色", "en": "brown orange" }, "shape": { "zh": "椭圆形薄膜衣片，约 14 mm；无刻痕", "en": "ovaloid film-coated tablet, about 14 mm; unscored" }, "imprint": "NVR / HXH", "scoreStatus": "unscored_do_not_split", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_ee6d762c05b73cb0", "label": "DailyMed（NLM）：DIOVAN HCT 160/25 mg、NDC 0078-0383-34、90 片瓶装当前美国标签面板", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d76a0419-05ee-437e-884c-65807aea9569", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-diovan-hct-valsartan-hctz-tablet-320-12-5mg-90-bottle-ndc-0078047134", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（SPL v34，2026-02-13 生效；2026-08-29 核验）", "en": "Current U.S. DailyMed public label (SPL v34, effective 13 Feb 2026; verified 29 Aug 2026)" }, "dosageForm": { "zh": "DIOVAN HCT 缬沙坦/氢氯噻嗪薄膜衣口服片", "en": "DIOVAN HCT valsartan/hydrochlorothiazide film-coated oral tablet" }, "route": { "zh": "口服（固定两成分产品身份字段）", "en": "oral (fixed two-ingredient product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 0078-0471-34", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片缬沙坦 320 mg＋氢氯噻嗪 12.5 mg；90 片瓶装", "en": "Valsartan 320 mg plus hydrochlorothiazide 12.5 mg per tablet; 90-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=diovan-hct-10.jpg&setid=d76a0419-05ee-437e-884c-65807aea9569", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "缬沙坦", "en": "valsartan" }, "value": 320, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片第一成分标签量；不是个人片数或换算指令", "en": "labelled amount of the first ingredient per tablet; not an individual tablet count or conversion instruction" } }, { "ingredient": { "zh": "氢氯噻嗪", "en": "hydrochlorothiazide" }, "value": 12.5, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片第二成分标签量；不是加用利尿药或换算指令", "en": "labelled amount of the second ingredient per tablet; not an instruction to add a diuretic or convert products" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 90, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-29", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 90, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "粉红色", "en": "pink" }, "shape": { "zh": "椭圆形薄膜衣片，约 18 mm；无刻痕", "en": "ovaloid film-coated tablet, about 18 mm; unscored" }, "imprint": "NVR / HIL", "scoreStatus": "unscored_do_not_split", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_ee6d762c05b73cb0", "label": "DailyMed（NLM）：DIOVAN HCT 320/12.5 mg、NDC 0078-0471-34、90 片瓶装当前美国标签面板", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d76a0419-05ee-437e-884c-65807aea9569", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-diovan-hct-valsartan-hctz-tablet-320-25mg-90-bottle-ndc-0078047234", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（SPL v34，2026-02-13 生效；2026-08-29 核验）", "en": "Current U.S. DailyMed public label (SPL v34, effective 13 Feb 2026; verified 29 Aug 2026)" }, "dosageForm": { "zh": "DIOVAN HCT 缬沙坦/氢氯噻嗪薄膜衣口服片", "en": "DIOVAN HCT valsartan/hydrochlorothiazide film-coated oral tablet" }, "route": { "zh": "口服（固定两成分产品身份字段）", "en": "oral (fixed two-ingredient product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 0078-0472-34", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片缬沙坦 320 mg＋氢氯噻嗪 25 mg；90 片瓶装", "en": "Valsartan 320 mg plus hydrochlorothiazide 25 mg per tablet; 90-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=diovan-hct-11.jpg&setid=d76a0419-05ee-437e-884c-65807aea9569", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "缬沙坦", "en": "valsartan" }, "value": 320, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片第一成分标签量；不是个人片数或换算指令", "en": "labelled amount of the first ingredient per tablet; not an individual tablet count or conversion instruction" } }, { "ingredient": { "zh": "氢氯噻嗪", "en": "hydrochlorothiazide" }, "value": 25, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片第二成分标签量；不是加用利尿药或换算指令", "en": "labelled amount of the second ingredient per tablet; not an instruction to add a diuretic or convert products" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 90, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-29", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 90, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "黄色", "en": "yellow" }, "shape": { "zh": "椭圆形薄膜衣片，约 18 mm；无刻痕", "en": "ovaloid film-coated tablet, about 18 mm; unscored" }, "imprint": "NVR / CTI", "scoreStatus": "unscored_do_not_split", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_ee6d762c05b73cb0", "label": "DailyMed（NLM）：DIOVAN HCT 320/25 mg、NDC 0078-0472-34、90 片瓶装当前美国标签面板", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d76a0419-05ee-437e-884c-65807aea9569", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-diovan-hct-valsartan-hctz-tablet-80-12-5mg-90-bottle-ndc-0078031434", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=diovan-hct-07.jpg&setid=d76a0419-05ee-437e-884c-65807aea9569", "alt": { "zh": "DailyMed 当前 DIOVAN HCT 80/12.5 mg、NDC 0078-0314-34、90 片瓶装标签面板", "en": "Current DailyMed DIOVAN HCT 80/12.5 mg, NDC 0078-0314-34, 90-tablet bottle label panel" }, "archiveMarket": "美国", "labelVersion": "DailyMed 当前美国公开标签（SPL v34，2026-02-13 生效）", "presentation": "DIOVAN HCT 缬沙坦 80 mg/氢氯噻嗪 12.5 mg 每片，NDC 0078-0314-34，90 片瓶装。", "notice": "此图只对应当前 DailyMed 标签中的 DIOVAN HCT 80/12.5 mg、NDC 0078-0314-34、90 片瓶装面板；不能代表其他四个规格、其他市场、仿制药或同类复方产品，也不用于鉴定真伪或决定个人片数。", "source": { "id": "src_ee6d762c05b73cb0", "label": "DailyMed（NLM）：DIOVAN HCT 80/12.5 mg、NDC 0078-0314-34、90 片瓶装当前美国标签面板", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d76a0419-05ee-437e-884c-65807aea9569", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "DIOVAN HCT 说明书放大阅读：斜线两边是两种成分，先排查缬沙坦与利尿药重复", "en": "DIOVAN HCT label reading: the two numbers are two ingredients; check duplicate valsartan and diuretics first" }, "summary": { "zh": "DIOVAN HCT 每片固定含缬沙坦和氢氯噻嗪。例如 160/12.5 mg 表示同一片内分别含 160 mg 与 12.5 mg；不能把它理解成半片、两片或可与其他产品直接相加换算。", "en": "Each DIOVAN HCT tablet contains fixed amounts of valsartan and hydrochlorothiazide. For example, 160/12.5 mg means 160 mg and 12.5 mg of the two ingredients in one tablet; it is not a half-tablet cue, a two-tablet cue or a sum that can be directly converted across products." }, "checks": [ { "zh": "逐盒核对有效成分。DIOVAN 是单方缬沙坦，MICROZIDE 是单方氢氯噻嗪；EXFORGE、EXFORGE HCT、ENTRESTO、HYZAAR 和 AVALIDE 也可能与本品共享一种成分。若同时出现在药单，不要自行删掉或加上任何一盒，应让药师或开方团队依据完整处方判断。", "en": "Check the active ingredients on every pack. DIOVAN is valsartan alone and MICROZIDE is hydrochlorothiazide alone; EXFORGE, EXFORGE HCT, ENTRESTO, HYZAAR and AVALIDE may also share an ingredient with this product. If they appear together, do not remove or add a pack yourself; a pharmacist or prescriber must review the complete prescriptions." }, { "zh": "头晕、晕厥、明显乏力、口渴、尿量显著减少、持续呕吐或腹泻、肌肉无力或抽筋、心跳异常，可能与血压、水分、肾功能或电解质变化有关。严重、突然或伴意识异常时应使用当地急救服务。", "en": "Dizziness, fainting, marked weakness, thirst, clearly reduced urine, persistent vomiting or diarrhoea, muscle weakness or cramps, or an abnormal heartbeat may accompany changes in blood pressure, fluid balance, kidney function or electrolytes. Use local emergency services for severe or sudden symptoms or altered consciousness." }, { "zh": "不要自行使用含钾补充剂或含钾代盐。锂盐、布洛芬或萘普生等 NSAID、其他影响肾素-血管紧张素系统的药，以及其他利尿或降压药，都需要结合完整药单核对；老人、水分不足或肾功能异常者尤其需要复核。", "en": "Do not use potassium supplements or potassium-containing salt substitutes without professional review. Lithium, NSAIDs such as ibuprofen or naproxen, other medicines affecting the renin-angiotensin system and other diuretic or blood-pressure medicines require review against the full medicine list, especially in older adults, volume depletion or kidney impairment." }, { "zh": "突然眼痛、视力快速下降或明显视物模糊需要及时就医；面唇舌喉肿胀、呼吸困难或晕厥应使用当地急救服务。", "en": "Sudden eye pain, rapidly reduced vision or marked blurred vision requires prompt medical assessment. Swelling of the face, lips, tongue or throat, breathing difficulty or fainting requires local emergency services." }, { "zh": "标签有胎儿毒性黑框警示。已经怀孕、可能怀孕或计划怀孕者应立即联系开方团队核对，不要等待网页判断，也不要用网页自行安排停换药。", "en": "The label carries a boxed warning for fetal toxicity. Anyone who is pregnant, may be pregnant or plans pregnancy should contact the prescribing team promptly; do not wait for a website decision or use the site to arrange stopping or switching." }, { "zh": "标签提醒使用氢氯噻嗪者做好防晒并按临床建议进行皮肤检查；这不表示一定会发生皮肤癌，也不是自行停药理由。", "en": "The label advises sun protection and skin screening as clinically directed for hydrochlorothiazide users. This does not mean skin cancer will occur and is not a reason to stop treatment independently." } ], "source": { "id": "src_ee6d762c05b73cb0", "label": "DailyMed（NLM）：DIOVAN HCT 缬沙坦/氢氯噻嗪当前美国公开标签（Novartis；SPL v34，2026-02-13 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d76a0419-05ee-437e-884c-65807aea9569", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "两种成分怎样协同：一项阻断血管紧张素 II 信号，一项帮助排出钠和水", "en": "How the two ingredients work together: one blocks angiotensin II signalling and one increases sodium and water excretion" }, "summary": { "zh": "当前标签说明：缬沙坦选择性阻断血管紧张素 II 的 AT1 受体作用；氢氯噻嗪减少一部分钠和氯的重吸收，使更多钠和水随尿排出。两条路径放在同一片中，不表示网页能按血压数字拆分或重组个人方案。", "en": "The current label explains that valsartan selectively blocks angiotensin II effects at the AT1 receptor, while hydrochlorothiazide reduces sodium and chloride reabsorption so more sodium and water leave in urine. Combining both paths in one tablet does not let the site split or rebuild an individual's regimen from a blood-pressure number." }, "checks": [ { "zh": "缬沙坦成分可能影响钾和肾功能，氢氯噻嗪成分可能造成低钾、低钠、低镁，也会影响尿酸、血糖、血脂和钙；不能只看“降压”两个字忽略化验、症状和完整药单。", "en": "Valsartan can affect potassium and kidney function; hydrochlorothiazide can cause low potassium, sodium or magnesium and affect urate, glucose, lipids and calcium. The words 'blood pressure' must not replace symptoms, laboratory review and the complete medicine list." }, { "zh": "五组双数字是五种完整产品身份。不同 mg 组合、颜色、印字和 NDC 不能由网页转换成个人加量、减量、掰片、补服或交替使用。", "en": "The five paired strengths are five complete product identities. Different milligram pairs, colours, imprints and NDCs cannot be converted by the site into an individual increase, decrease, split, make-up use or alternation plan." }, { "zh": "老人或存在肾功能、肝功能、糖尿病、痛风、水分不足等情况时，更需要专业人员结合实际药盒和监测结果复核；网页不根据年龄或化验自动生成方案。", "en": "Older adults and people with kidney or liver impairment, diabetes, gout or volume depletion particularly need professional review using the actual packs and monitoring results; the site does not generate a regimen from age or laboratory values." } ], "source": { "id": "src_ee6d762c05b73cb0", "label": "DailyMed（NLM）：DIOVAN HCT 缬沙坦/氢氯噻嗪当前美国公开标签（Novartis；SPL v34，2026-02-13 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d76a0419-05ee-437e-884c-65807aea9569", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "DIOVAN HCT", "generic": "缬沙坦/氢氯噻嗪片", "dosageFormClass": "缬沙坦/氢氯噻嗪固定两成分薄膜衣口服片：80/12.5 mg、160/12.5 mg、160/25 mg、320/12.5 mg、320/25 mg；每组两个数字属于同一片内两种成分" }, "labelSource": { "id": "src_ee6d762c05b73cb0", "label": "DailyMed（NLM）：DIOVAN HCT 缬沙坦/氢氯噻嗪当前美国公开标签（Novartis；SPL v34，2026-02-13 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d76a0419-05ee-437e-884c-65807aea9569", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "productRoutes": [ { "source": { "id": "src_ee6d762c05b73cb0", "label": "DailyMed（NLM）：DIOVAN HCT 缬沙坦/氢氯噻嗪当前美国公开标签（Novartis；SPL v34，2026-02-13 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d76a0419-05ee-437e-884c-65807aea9569", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-29", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_10e511bf83430e3b", "label": "FDA Orange Book 当前数据：DIOVAN HCT，NDA 020818，五个口服片规格均列为处方 RLD", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-08-29", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-29", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "DIOVAN HCT 一片同时含缬沙坦和氢氯噻嗪。药盒上的 80/12.5、160/12.5、160/25、320/12.5 或 320/25 不是分片算式，而是每片两种成分各有多少毫克。若药单还有单方 DIOVAN、MICROZIDE，或 EXFORGE HCT、HYZAAR、AVALIDE 等其他含相同成分产品，要先让药师或开方团队核对是否重复；不要自行加药、停药或轮换。", "history": "FDA Orange Book 当前数据记录 DIOVAN HCT NDA 020818：80/12.5 mg 与 160/12.5 mg 于 1998-03-06 获批，160/25 mg 于 2002-01-17 获批，320/12.5 mg 与 320/25 mg 于 2006-04-28 获批；五个规格均列为处方 RLD。当前 DailyMed SPL v34 于 2026-02-13 生效并保留五个准确 90 片瓶装面板。", "sourceDocuments": [ { "id": "src_ee6d762c05b73cb0", "label": "DailyMed（NLM）：DIOVAN HCT 缬沙坦/氢氯噻嗪当前美国公开标签（Novartis；SPL v34，2026-02-13 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d76a0419-05ee-437e-884c-65807aea9569", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, { "id": "src_10e511bf83430e3b", "label": "FDA Orange Book 当前数据：DIOVAN HCT，NDA 020818，五个口服片规格均列为处方 RLD", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } ], "applicationNumber": "FDA NDA 020818（DIOVAN HCT / valsartan and hydrochlorothiazide oral tablets）", "approvalTimeline": [ { "date": "1998-03-06", "title": { "zh": "80/12.5 mg 与 160/12.5 mg 原始批准", "en": "Original approval of 80/12.5 mg and 160/12.5 mg" }, "detail": { "zh": "Orange Book 当前数据将两规格列为 NDA 020818 产品 001、002 和处方 RLD。", "en": "Current Orange Book data list both strengths as NDA 020818 products 001 and 002 and prescription RLD products." }, "source": { "id": "src_10e511bf83430e3b", "label": "FDA Orange Book 当前数据：DIOVAN HCT，NDA 020818，五个口服片规格均列为处方 RLD", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } }, { "date": "2002-01-17", "title": { "zh": "160/25 mg 获批", "en": "Approval of 160/25 mg" }, "detail": { "zh": "Orange Book 当前数据将该规格列为产品 003、处方 RLD。", "en": "Current Orange Book data list this strength as product 003 and a prescription RLD." }, "source": { "id": "src_10e511bf83430e3b", "label": "FDA Orange Book 当前数据：DIOVAN HCT，NDA 020818，五个口服片规格均列为处方 RLD", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } }, { "date": "2006-04-28", "title": { "zh": "320/12.5 mg 与 320/25 mg 获批", "en": "Approval of 320/12.5 mg and 320/25 mg" }, "detail": { "zh": "Orange Book 当前数据将两规格列为产品 004、005 和处方 RLD；320/25 mg 同时为 RS。", "en": "Current Orange Book data list both strengths as products 004 and 005 and prescription RLD products; 320/25 mg is also the RS." }, "source": { "id": "src_10e511bf83430e3b", "label": "FDA Orange Book 当前数据：DIOVAN HCT，NDA 020818，五个口服片规格均列为处方 RLD", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } }, { "date": "2026-02-13", "title": { "zh": "当前 SPL v34 生效", "en": "Current SPL v34 became effective" }, "detail": { "zh": "DailyMed 当前页面保留五个规格、包装、外观、黑框警示及相互作用等说明书入口。", "en": "The current DailyMed page retains five strengths, packs, appearances, the boxed warning, interactions and other label-reading routes." }, "source": { "id": "src_ee6d762c05b73cb0", "label": "DailyMed（NLM）：DIOVAN HCT 缬沙坦/氢氯噻嗪当前美国公开标签（Novartis；SPL v34，2026-02-13 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d76a0419-05ee-437e-884c-65807aea9569", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "当前 DailyMed 品牌标签；Orange Book 五规格均列为处方 RLD", "en": "Current DailyMed brand label; all five strengths are listed as prescription RLD products in the Orange Book" }, "detail": { "zh": "本页展示五个 90 片瓶装面板；不由标签推断特定药店库存或购买资格。", "en": "This page displays five 90-tablet bottle panels; the label does not establish stock at a particular pharmacy or purchasing eligibility." } }, { "market": { "zh": "中国大陆及其他市场", "en": "Mainland China and other markets" }, "status": { "zh": "待逐项建立现行市场记录", "en": "Current market record not established" }, "detail": { "zh": "不从美国品牌、共同成分或 mg 数字推定当地批准、商品名、包装、供应或可替代性。", "en": "No local approval, trade name, pack, supply or interchangeability is inferred from the U.S. brand, shared ingredients or milligram numbers." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "160/12.5 mg 是不是把药片掰一半？", "en": "Does 160/12.5 mg mean splitting the tablet in half?" }, "answer": { "zh": "不是。它表示同一片内有缬沙坦 160 mg 和氢氯噻嗪 12.5 mg。标签列示片剂无刻痕；网页不会把双数字转换为掰片或个人片数。", "en": "No. It means one tablet contains valsartan 160 mg and hydrochlorothiazide 12.5 mg. The label lists the tablets as unscored, and the site does not convert the paired numbers into splitting or an individual tablet count." } }, { "question": { "zh": "已经吃 DIOVAN HCT，还能再吃 DIOVAN 或 MICROZIDE 吗？", "en": "Can DIOVAN or MICROZIDE be taken in addition to DIOVAN HCT?" }, "answer": { "zh": "网页不能替个人决定。DIOVAN HCT 已含缬沙坦和氢氯噻嗪，再出现单方同成分可能是重复，也可能是专业人员有意安排；只有准确处方、实际药盒和完整药单才能判断。不要自行加上或停掉任何一盒。", "en": "The website cannot decide for an individual. DIOVAN HCT already contains valsartan and hydrochlorothiazide, so an additional single-ingredient product may be duplicative or intentionally prescribed; only exact prescriptions, packs and the complete medicine list can establish that. Do not add or stop a pack yourself." } }, { "question": { "zh": "五种颜色不同，能按颜色互相替换吗？", "en": "Can the five products be substituted by colour?" }, "answer": { "zh": "不能。颜色和印字分别对应不同双成分强度与 NDC；颜色只作辅助外观线索，不能证明真伪、适用性或可替代性。", "en": "No. Colours and imprints correspond to different two-ingredient strengths and NDCs. Colour is only an appearance clue and does not establish authenticity, suitability or interchangeability." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "how-to-read-a-drug-label", "dosage-forms-are-part-of-medicine-identity" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/diovan-hct/", "en": "https://origindrug.com/en/drugs/diovan-hct/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "zestoretic", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-29", "status": "published_traceable_archive" }, "names": { "brand": "ZESTORETIC", "generic": "赖诺普利/氢氯噻嗪片", "aliases": [ "Zestoretic", "lisinopril hydrochlorothiazide", "lisinopril and hydrochlorothiazide", "lisinopril/HCTZ", "赖诺普利氢氯噻嗪", "赖诺普利氢氯噻嗪片", "NDA 019888", "52427-435-90", "52427-436-90", "52427-437-90", "DIN 02045729", "DIN 02045737", "DIN 02103729" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "心血管", "sourceArchiveMarket": "美国：DailyMed 当前 ZESTORETIC 标签列示赖诺普利/氢氯噻嗪无包衣口服片、三个规格与三个 90 片瓶装面板；FDA Orange Book 当前数据将 NDA 019888 三个规格列为处方 RLD。加拿大：Health Canada DPD 当前索引列出三个在售 DIN，现行产品说明书列示 10/12.5、20/12.5 与 20/25 mg。两个市场记录分别阅读，不把美国 NDC、加拿大 DIN、包装、供应或可替代性互相推定。", "dosageFormClass": "赖诺普利/氢氯噻嗪固定两成分无包衣口服片：10/12.5 mg、20/12.5 mg、20/25 mg；每组两个数字属于同一片内两种成分", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "1989", "archiveSponsorText": "Almatica Pharma LLC（美国当前 DailyMed 标签与 FDA Orange Book 数据）；Searchlight Pharma Inc.（加拿大当前 DPD 与产品说明书）" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [ "ZESTRIL", "lisinopril tablet", "MICROZIDE", "hydrochlorothiazide capsule", "ENTRESTO", "HYZAAR", "DIOVAN HCT", "AVALIDE", "EXFORGE HCT" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-zestoretic-lisinopril-hctz-tablet-10-12-5mg-90-bottle-ndc-5242743590", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（2025-03 修订；2026-08-29 核验）", "en": "Current U.S. DailyMed public label (revised Mar 2025; verified 29 Aug 2026)" }, "dosageForm": { "zh": "ZESTORETIC 赖诺普利/氢氯噻嗪无包衣口服片", "en": "ZESTORETIC lisinopril/hydrochlorothiazide uncoated oral tablet" }, "route": { "zh": "口服（固定两成分产品身份字段）", "en": "oral (fixed two-ingredient product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 52427-435-90", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片赖诺普利 10 mg＋氢氯噻嗪 12.5 mg；90 片瓶装", "en": "Lisinopril 10 mg plus hydrochlorothiazide 12.5 mg per tablet; 90-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=lbl-10mg-12pt5mg.jpg&setid=0d3a966f-f937-05a8-a90f-5aa52ebbd613", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "赖诺普利", "en": "lisinopril" }, "value": 10, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片第一成分标签量；不是个人片数或换算指令", "en": "labelled amount of the first ingredient per tablet; not an individual tablet count or conversion instruction" } }, { "ingredient": { "zh": "氢氯噻嗪", "en": "hydrochlorothiazide" }, "value": 12.5, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片第二成分标签量；不是加用利尿药或换算指令", "en": "labelled amount of the second ingredient per tablet; not an instruction to add a diuretic or convert products" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 90, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-29", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 90, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "桃色至粉红色", "en": "peach to pink" }, "shape": { "zh": "圆形、双凸、无包衣片，约 6 mm；无刻痕", "en": "round, biconvex, uncoated tablet, about 6 mm; unscored" }, "imprint": "ZESTORETIC / 141", "scoreStatus": "unscored_do_not_split", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_d809d00465b8e2d8", "label": "DailyMed（NLM）：ZESTORETIC 10/12.5 mg、NDC 52427-435-90、90 片瓶装当前美国标签面板", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=0d3a966f-f937-05a8-a90f-5aa52ebbd613", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-zestoretic-lisinopril-hctz-tablet-20-12-5mg-90-bottle-ndc-5242743690", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（2025-03 修订；2026-08-29 核验）", "en": "Current U.S. DailyMed public label (revised Mar 2025; verified 29 Aug 2026)" }, "dosageForm": { "zh": "ZESTORETIC 赖诺普利/氢氯噻嗪无包衣口服片", "en": "ZESTORETIC lisinopril/hydrochlorothiazide uncoated oral tablet" }, "route": { "zh": "口服（固定两成分产品身份字段）", "en": "oral (fixed two-ingredient product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 52427-436-90", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片赖诺普利 20 mg＋氢氯噻嗪 12.5 mg；90 片瓶装", "en": "Lisinopril 20 mg plus hydrochlorothiazide 12.5 mg per tablet; 90-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=lbl-20mg-12pt5mg.jpg&setid=0d3a966f-f937-05a8-a90f-5aa52ebbd613", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "赖诺普利", "en": "lisinopril" }, "value": 20, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片第一成分标签量；不是个人片数或换算指令", "en": "labelled amount of the first ingredient per tablet; not an individual tablet count or conversion instruction" } }, { "ingredient": { "zh": "氢氯噻嗪", "en": "hydrochlorothiazide" }, "value": 12.5, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片第二成分标签量；不是加用利尿药或换算指令", "en": "labelled amount of the second ingredient per tablet; not an instruction to add a diuretic or convert products" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 90, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-29", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 90, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "白色", "en": "white" }, "shape": { "zh": "圆形、双凸、无包衣片，约 8 mm；无刻痕", "en": "round, biconvex, uncoated tablet, about 8 mm; unscored" }, "imprint": "ZESTORETIC / 142", "scoreStatus": "unscored_do_not_split", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_d809d00465b8e2d8", "label": "DailyMed（NLM）：ZESTORETIC 20/12.5 mg、NDC 52427-436-90、90 片瓶装当前美国标签面板", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=0d3a966f-f937-05a8-a90f-5aa52ebbd613", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-zestoretic-lisinopril-hctz-tablet-20-25mg-90-bottle-ndc-5242743790", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（2025-03 修订；2026-08-29 核验）", "en": "Current U.S. DailyMed public label (revised Mar 2025; verified 29 Aug 2026)" }, "dosageForm": { "zh": "ZESTORETIC 赖诺普利/氢氯噻嗪无包衣口服片", "en": "ZESTORETIC lisinopril/hydrochlorothiazide uncoated oral tablet" }, "route": { "zh": "口服（固定两成分产品身份字段）", "en": "oral (fixed two-ingredient product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 52427-437-90", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片赖诺普利 20 mg＋氢氯噻嗪 25 mg；90 片瓶装", "en": "Lisinopril 20 mg plus hydrochlorothiazide 25 mg per tablet; 90-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=lbl-20mg-25mg.jpg&setid=0d3a966f-f937-05a8-a90f-5aa52ebbd613", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "赖诺普利", "en": "lisinopril" }, "value": 20, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片第一成分标签量；不是个人片数或换算指令", "en": "labelled amount of the first ingredient per tablet; not an individual tablet count or conversion instruction" } }, { "ingredient": { "zh": "氢氯噻嗪", "en": "hydrochlorothiazide" }, "value": 25, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片第二成分标签量；不是加用利尿药或换算指令", "en": "labelled amount of the second ingredient per tablet; not an instruction to add a diuretic or convert products" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 90, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-29", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 90, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "桃色至粉红色", "en": "peach to pink" }, "shape": { "zh": "圆形、双凸、无包衣片，约 8 mm；无刻痕", "en": "round, biconvex, uncoated tablet, about 8 mm; unscored" }, "imprint": "ZESTORETIC / 145", "scoreStatus": "unscored_do_not_split", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_d809d00465b8e2d8", "label": "DailyMed（NLM）：ZESTORETIC 20/25 mg、NDC 52427-437-90、90 片瓶装当前美国标签面板", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=0d3a966f-f937-05a8-a90f-5aa52ebbd613", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-zestoretic-lisinopril-hctz-tablet-10-12-5mg-90-bottle-ndc-5242743590", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=lbl-10mg-12pt5mg.jpg&setid=0d3a966f-f937-05a8-a90f-5aa52ebbd613", "alt": { "zh": "DailyMed 当前 ZESTORETIC 10/12.5 mg、NDC 52427-435-90、90 片瓶装标签面板", "en": "Current DailyMed ZESTORETIC 10/12.5 mg, NDC 52427-435-90, 90-tablet bottle label panel" }, "archiveMarket": "美国", "labelVersion": "DailyMed 当前美国公开标签（2025-03 修订）", "presentation": "ZESTORETIC 赖诺普利 10 mg/氢氯噻嗪 12.5 mg 每片，NDC 52427-435-90，90 片瓶装。", "notice": "此图只对应当前 DailyMed 标签中的 ZESTORETIC 10/12.5 mg、NDC 52427-435-90、90 片瓶装面板；不能代表另两个规格、加拿大 DIN/包装、其他市场、仿制药或同类复方产品，也不用于鉴定真伪或决定个人片数。", "source": { "id": "src_d809d00465b8e2d8", "label": "DailyMed（NLM）：ZESTORETIC 10/12.5 mg、NDC 52427-435-90、90 片瓶装当前美国标签面板", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=0d3a966f-f937-05a8-a90f-5aa52ebbd613", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "ZESTORETIC 说明书放大阅读：一片已有两种成分，先排查赖诺普利与利尿药重复", "en": "ZESTORETIC label reading: one tablet already has two ingredients; check duplicate lisinopril and diuretics first" }, "summary": { "zh": "ZESTORETIC 每片固定含赖诺普利和氢氯噻嗪。例如 20/12.5 mg 表示同一片内分别含 20 mg 与 12.5 mg；不能把它理解成半片、两片或可与其他产品直接相加换算。", "en": "Each ZESTORETIC tablet contains fixed amounts of lisinopril and hydrochlorothiazide. For example, 20/12.5 mg means 20 mg and 12.5 mg of the two ingredients in one tablet; it is not a half-tablet cue, a two-tablet cue or a sum that can be directly converted across products." }, "checks": [ { "zh": "逐盒核对有效成分。ZESTRIL 是单方赖诺普利，MICROZIDE 是单方氢氯噻嗪；HYZAAR、DIOVAN HCT、AVALIDE 和 EXFORGE HCT 也含氢氯噻嗪。若同时出现在药单，不要自行删掉或加上任何一盒，应让药师或开方团队依据完整处方判断。", "en": "Check the active ingredients on every pack. ZESTRIL is lisinopril alone and MICROZIDE is hydrochlorothiazide alone; HYZAAR, DIOVAN HCT, AVALIDE and EXFORGE HCT also contain hydrochlorothiazide. If they appear together, do not remove or add a pack yourself; a pharmacist or prescriber must review the complete prescriptions." }, { "zh": "ENTRESTO 含沙库巴曲/缬沙坦。当前 ZESTORETIC 标签把含奈普利酶抑制剂的产品列为特殊禁忌边界，并明确 ACE 抑制剂切换前后 36 小时限制；网页不据此给个人安排停药或换药，应立即联系开方团队或药师核对。", "en": "ENTRESTO contains sacubitril/valsartan. The current ZESTORETIC label identifies products containing a neprilysin inhibitor as a special contraindication boundary and states a 36-hour restriction around switching an ACE inhibitor. The site does not use that statement to arrange an individual's stopping or switching; contact the prescriber or pharmacist promptly for review." }, { "zh": "面、唇、舌或咽喉肿胀，吞咽或呼吸困难，可能是血管性水肿；应立即使用当地急救服务。不要等待网页判断。", "en": "Swelling of the face, lips, tongue or throat, or difficulty swallowing or breathing, may be angioedema and requires local emergency services immediately. Do not wait for a website assessment." }, { "zh": "头晕、晕厥、明显乏力、口渴、尿量显著减少、持续呕吐或腹泻、肌肉无力或抽筋、心跳异常，可能与血压、水分、肾功能或电解质变化有关。严重、突然或伴意识异常时应使用当地急救服务。", "en": "Dizziness, fainting, marked weakness, thirst, clearly reduced urine, persistent vomiting or diarrhoea, muscle weakness or cramps, or an abnormal heartbeat may accompany changes in blood pressure, fluid balance, kidney function or electrolytes. Use local emergency services for severe or sudden symptoms or altered consciousness." }, { "zh": "不要自行使用含钾补充剂或含钾代盐。锂盐、布洛芬或萘普生等 NSAID、其他影响肾素-血管紧张素系统的药，以及其他利尿或降压药，都需要结合完整药单核对；老人、水分不足或肾功能异常者尤其需要复核。", "en": "Do not use potassium supplements or potassium-containing salt substitutes without professional review. Lithium, NSAIDs such as ibuprofen or naproxen, other medicines affecting the renin-angiotensin system and other diuretic or blood-pressure medicines require review against the full medicine list, especially in older adults, volume depletion or kidney impairment." }, { "zh": "突然眼痛、视力快速下降或明显视物模糊需要及时就医。标签还提醒使用氢氯噻嗪者做好防晒并按临床建议进行皮肤检查；这不是自行停药理由。", "en": "Sudden eye pain, rapidly reduced vision or marked blurred vision requires prompt medical assessment. The label also advises sun protection and skin screening as clinically directed for hydrochlorothiazide users; this is not a reason to stop treatment independently." }, { "zh": "标签有胎儿毒性黑框警示。已经怀孕、可能怀孕或计划怀孕者应立即联系开方团队核对，不要等待网页判断，也不要用网页自行安排停换药。", "en": "The label carries a boxed warning for fetal toxicity. Anyone who is pregnant, may be pregnant or plans pregnancy should contact the prescribing team promptly; do not wait for a website decision or use the site to arrange stopping or switching." } ], "source": { "id": "src_d809d00465b8e2d8", "label": "DailyMed（NLM）：ZESTORETIC 赖诺普利/氢氯噻嗪当前美国公开标签（Almatica；2025-03 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=0d3a966f-f937-05a8-a90f-5aa52ebbd613", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "两种成分怎样协同：一项减少血管紧张素 II 形成，一项帮助排出钠和水", "en": "How the two ingredients work together: one reduces angiotensin II formation and one increases sodium and water excretion" }, "summary": { "zh": "当前标签说明：赖诺普利抑制血管紧张素转换酶，使血管紧张素 II 形成减少并降低醛固酮分泌；氢氯噻嗪减少一部分钠和氯的重吸收，使更多钠和水随尿排出。两条路径放在同一片中，不表示网页能按血压数字拆分或重组个人方案。", "en": "The current label explains that lisinopril inhibits angiotensin-converting enzyme, reducing angiotensin II formation and aldosterone secretion, while hydrochlorothiazide reduces sodium and chloride reabsorption so more sodium and water leave in urine. Combining both paths in one tablet does not let the site split or rebuild an individual's regimen from a blood-pressure number." }, "checks": [ { "zh": "赖诺普利成分可能影响钾和肾功能，氢氯噻嗪成分可能造成低钾、低钠、低镁，也会影响尿酸、血糖、血脂和钙；不能只看“降压”两个字忽略化验、症状和完整药单。", "en": "Lisinopril can affect potassium and kidney function; hydrochlorothiazide can cause low potassium, sodium or magnesium and affect urate, glucose, lipids and calcium. The words 'blood pressure' must not replace symptoms, laboratory review and the complete medicine list." }, { "zh": "三组双数字是三种完整产品身份。不同 mg 组合、颜色、印字、NDC 与加拿大 DIN 不能由网页转换成个人加量、减量、掰片、补服或交替使用。", "en": "The three paired strengths are three complete product identities. Different milligram pairs, colours, imprints, NDCs and Canadian DINs cannot be converted by the site into an individual increase, decrease, split, make-up use or alternation plan." }, { "zh": "老人或存在肾功能、肝功能、糖尿病、痛风、水分不足等情况时，更需要专业人员结合实际药盒和监测结果复核；网页不根据年龄或化验自动生成方案。", "en": "Older adults and people with kidney or liver impairment, diabetes, gout or volume depletion particularly need professional review using the actual packs and monitoring results; the site does not generate a regimen from age or laboratory values." } ], "source": { "id": "src_d809d00465b8e2d8", "label": "DailyMed（NLM）：ZESTORETIC 赖诺普利/氢氯噻嗪当前美国公开标签（Almatica；2025-03 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=0d3a966f-f937-05a8-a90f-5aa52ebbd613", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "ZESTORETIC", "generic": "赖诺普利/氢氯噻嗪片", "dosageFormClass": "赖诺普利/氢氯噻嗪固定两成分无包衣口服片：10/12.5 mg、20/12.5 mg、20/25 mg；每组两个数字属于同一片内两种成分" }, "labelSource": { "id": "src_d809d00465b8e2d8", "label": "DailyMed（NLM）：ZESTORETIC 赖诺普利/氢氯噻嗪当前美国公开标签（Almatica；2025-03 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=0d3a966f-f937-05a8-a90f-5aa52ebbd613", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "productRoutes": [ { "source": { "id": "src_d809d00465b8e2d8", "label": "DailyMed（NLM）：ZESTORETIC 赖诺普利/氢氯噻嗪当前美国公开标签（Almatica；2025-03 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=0d3a966f-f937-05a8-a90f-5aa52ebbd613", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-29", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_10e511bf83430e3b", "label": "FDA Orange Book 当前数据：ZESTORETIC，NDA 019888，三个口服片规格均列为处方 RLD", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-08-29", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-29", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "ZESTORETIC 一片同时含赖诺普利和氢氯噻嗪。药盒上的 10/12.5、20/12.5 或 20/25 不是分片算式，而是每片两种成分各有多少毫克。若药单还有单方 ZESTRIL、MICROZIDE，或 HYZAAR、DIOVAN HCT、AVALIDE、EXFORGE HCT 等其他含氢氯噻嗪产品，应先让药师或开方团队核对是否重复；若出现 ENTRESTO，还要按官方说明书核对 ACE 抑制剂的特殊间隔边界。不要自行加药、停药或轮换。", "history": "FDA Orange Book 当前数据记录 ZESTORETIC NDA 019888：20/25 mg 于 1989-07-20 获批，20/12.5 mg 于 1990-09-20 获批，10/12.5 mg 于 1993-11-18 获批；三个规格均列为处方 RLD。当前美国 DailyMed 标签于 2025-03 修订。加拿大产品说明书记录初次授权日为 1992-10-07、修订日为 2023-11-10；DPD 当前索引于 2025-03-22 更新，列出三个在售 DIN。", "sourceDocuments": [ { "id": "src_d809d00465b8e2d8", "label": "DailyMed（NLM）：ZESTORETIC 赖诺普利/氢氯噻嗪当前美国公开标签（Almatica；2025-03 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=0d3a966f-f937-05a8-a90f-5aa52ebbd613", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, { "id": "src_10e511bf83430e3b", "label": "FDA Orange Book 当前数据：ZESTORETIC，NDA 019888，三个口服片规格均列为处方 RLD", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, { "id": "src_f569b57eee87a182", "label": "Health Canada：药品产品数据库（DPD）当前访问页；在库内核对 ZESTORETIC／DIN 的官方入口", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_lookup_entry", "documentKind": "regulatory_lookup", "market": "CA", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-09-13", "reviewedAt": "2026-09-13" }, { "id": "src_1400461f2de8298b", "label": "Health Canada：ZESTORETIC 加拿大产品说明书（10/12.5、20/12.5、20/25 mg；2023-11-10 修订）", "url": "https://pdf.hres.ca/dpd_pm/00073386.PDF", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_monograph", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_pdf", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } ], "applicationNumber": "FDA NDA 019888（ZESTORETIC / lisinopril and hydrochlorothiazide oral tablets）", "approvalTimeline": [ { "date": "1989-07-20", "title": { "zh": "20/25 mg 原始批准", "en": "Original approval of 20/25 mg" }, "detail": { "zh": "Orange Book 当前数据将该规格列为 NDA 019888 产品 002 和处方 RLD。", "en": "Current Orange Book data list this strength as NDA 019888 product 002 and a prescription RLD." }, "source": { "id": "src_10e511bf83430e3b", "label": "FDA Orange Book 当前数据：ZESTORETIC，NDA 019888，三个口服片规格均列为处方 RLD", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } }, { "date": "1990-09-20", "title": { "zh": "20/12.5 mg 获批", "en": "Approval of 20/12.5 mg" }, "detail": { "zh": "Orange Book 当前数据将该规格列为产品 001、处方 RLD。", "en": "Current Orange Book data list this strength as product 001 and a prescription RLD." }, "source": { "id": "src_10e511bf83430e3b", "label": "FDA Orange Book 当前数据：ZESTORETIC，NDA 019888，三个口服片规格均列为处方 RLD", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } }, { "date": "1992-10-07", "title": { "zh": "加拿大初次授权节点", "en": "Canadian initial authorisation milestone" }, "detail": { "zh": "加拿大现行产品说明书记录该初次授权日期；加拿大监管记录与美国 NDA 分开阅读。", "en": "The current Canadian product monograph records this initial authorisation date; the Canadian regulatory record is read separately from the U.S. NDA." }, "source": { "id": "src_1400461f2de8298b", "label": "Health Canada：ZESTORETIC 加拿大产品说明书（10/12.5、20/12.5、20/25 mg；2023-11-10 修订）", "url": "https://pdf.hres.ca/dpd_pm/00073386.PDF", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_monograph", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_pdf", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } }, { "date": "1993-11-18", "title": { "zh": "10/12.5 mg 获批", "en": "Approval of 10/12.5 mg" }, "detail": { "zh": "Orange Book 当前数据将该规格列为产品 003、处方 RLD。", "en": "Current Orange Book data list this strength as product 003 and a prescription RLD." }, "source": { "id": "src_10e511bf83430e3b", "label": "FDA Orange Book 当前数据：ZESTORETIC，NDA 019888，三个口服片规格均列为处方 RLD", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } }, { "date": "2023-11-10", "title": { "zh": "加拿大现行产品说明书修订", "en": "Current Canadian product monograph revised" }, "detail": { "zh": "现行说明书列示三个双成分规格及加拿大产品安全信息；不用于推定美国包装。", "en": "The current monograph lists the three two-ingredient strengths and Canadian product safety information; it does not establish a U.S. pack." }, "source": { "id": "src_1400461f2de8298b", "label": "Health Canada：ZESTORETIC 加拿大产品说明书（10/12.5、20/12.5、20/25 mg；2023-11-10 修订）", "url": "https://pdf.hres.ca/dpd_pm/00073386.PDF", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_monograph", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_pdf", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } }, { "date": "2025-03-31", "title": { "zh": "当前美国 DailyMed 页面更新", "en": "Current U.S. DailyMed page updated" }, "detail": { "zh": "DailyMed 当前页面保留三个准确包装面板、黑框警示、禁忌、相互作用和其他说明书入口。", "en": "The current DailyMed page retains three exact pack panels, the boxed warning, contraindications, interactions and other label-reading routes." }, "source": { "id": "src_d809d00465b8e2d8", "label": "DailyMed（NLM）：ZESTORETIC 赖诺普利/氢氯噻嗪当前美国公开标签（Almatica；2025-03 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=0d3a966f-f937-05a8-a90f-5aa52ebbd613", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "当前 DailyMed 品牌标签；Orange Book 三规格均列为处方 RLD", "en": "Current DailyMed brand label; all three strengths are listed as prescription RLD products in the Orange Book" }, "detail": { "zh": "本页展示三个 90 片瓶装面板；不由标签推断特定药店库存或购买资格。", "en": "This page displays three 90-tablet bottle panels; the label does not establish stock at a particular pharmacy or purchasing eligibility." } }, { "market": { "zh": "加拿大", "en": "Canada" }, "status": { "zh": "DPD 三个 DIN 当前列为在售；现行产品说明书已链接", "en": "Three DINs are currently listed as marketed in the DPD; current product monograph linked" }, "detail": { "zh": "DIN 02045729、02045737、02103729 属加拿大市场记录；不与美国 NDC 或包装混写，也不证明特定药房实时库存。", "en": "DIN 02045729, 02045737 and 02103729 are Canadian market records; they are not merged with U.S. NDCs or packs and do not establish live stock at a particular pharmacy." } }, { "market": { "zh": "中国大陆及其他市场", "en": "Mainland China and other markets" }, "status": { "zh": "待逐项建立现行市场记录", "en": "Current market record not established" }, "detail": { "zh": "不从美国或加拿大品牌、共同成分或 mg 数字推定当地批准、商品名、包装、供应或可替代性。", "en": "No local approval, trade name, pack, supply or interchangeability is inferred from the U.S. or Canadian brand, shared ingredients or milligram numbers." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "20/12.5 mg 是不是把药片掰一半？", "en": "Does 20/12.5 mg mean splitting the tablet in half?" }, "answer": { "zh": "不是。它表示同一片内有赖诺普利 20 mg 和氢氯噻嗪 12.5 mg。美国标签列示片剂无刻痕；网页不会把双数字转换为掰片或个人片数。", "en": "No. It means one tablet contains lisinopril 20 mg and hydrochlorothiazide 12.5 mg. The U.S. label lists the tablets as unscored, and the site does not convert the paired numbers into splitting or an individual tablet count." } }, { "question": { "zh": "已经吃 ZESTORETIC，还能再吃 ZESTRIL 或 MICROZIDE 吗？", "en": "Can ZESTRIL or MICROZIDE be taken in addition to ZESTORETIC?" }, "answer": { "zh": "网页不能替个人决定。ZESTORETIC 已含赖诺普利和氢氯噻嗪，再出现单方同成分可能是重复，也可能是专业人员有意安排；只有准确处方、实际药盒和完整药单才能判断。不要自行加上或停掉任何一盒。", "en": "The website cannot decide for an individual. ZESTORETIC already contains lisinopril and hydrochlorothiazide, so an additional single-ingredient product may be duplicative or intentionally prescribed; only exact prescriptions, packs and the complete medicine list can establish that. Do not add or stop a pack yourself." } }, { "question": { "zh": "美国 NDC 和加拿大 DIN 能直接对照换药吗？", "en": "Can a U.S. NDC and a Canadian DIN be used to switch products directly?" }, "answer": { "zh": "不能。它们是不同监管市场的产品标识。即使双成分和 mg 数字相近，也必须分别核对当地说明书、剂型、包装、处方和专业人员判断。", "en": "No. They are product identifiers from different regulatory markets. Even when the two ingredients and milligram numbers look similar, the local monograph, dosage form, pack, prescription and professional review must be checked separately." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "how-to-read-a-drug-label", "dosage-forms-are-part-of-medicine-identity" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/zestoretic/", "en": "https://origindrug.com/en/drugs/zestoretic/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "lotrel", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-29", "status": "published_traceable_archive" }, "names": { "brand": "LOTREL", "generic": "氨氯地平/盐酸贝那普利胶囊", "aliases": [ "Lotrel", "amlodipine benazepril", "amlodipine and benazepril hydrochloride", "amlodipine/benazepril", "氨氯地平贝那普利", "氨氯地平贝那普利胶囊", "氨氯地平/贝那普利", "NDA 020364", "0078-0405-05", "0078-0406-05", "0078-0364-05", "0078-0379-05", "Lotrel 2260", "Lotrel 2265", "Lotrel 0364", "Lotrel 0379" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "心血管", "sourceArchiveMarket": "美国：DailyMed 当前公开 LOTREL 标签（2023-08 修订）列示氨氯地平/盐酸贝那普利口服胶囊、四个规格及四个 100 粒瓶装面板；FDA Orange Book 与 Drugs@FDA 2026-08-28 数据将 NDA 020364 的六个历史规格均列为 RLD、RS 为 No、Marketing Status 为 Discontinued。公开标签用于阅读，不证明当前供应、库存、购买资格或可替代性。", "dosageFormClass": "氨氯地平/盐酸贝那普利固定两成分口服胶囊：当前公开标签列示 5/10、5/20、10/20、10/40 mg；每组两个数字属于同一粒胶囊内两种成分", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "1995", "archiveSponsorText": "Sandoz Inc.（FDA 当前申请记录）；DailyMed（NLM）当前公开品牌标签" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [ "NORVASC", "amlodipine tablet", "LOTENSIN", "benazepril tablet", "ZESTRIL", "VASOTEC", "ALTACE", "CAPOTEN", "ENTRESTO", "EXFORGE", "CADUET" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-lotrel-amlodipine-benazepril-capsule-5-10mg-100-bottle-ndc-0078040505", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（2023-08 修订；2026-08-29 核验）", "en": "Current U.S. DailyMed public label (revised Aug 2023; verified 29 Aug 2026)" }, "dosageForm": { "zh": "LOTREL 氨氯地平/盐酸贝那普利口服胶囊", "en": "LOTREL amlodipine/benazepril hydrochloride oral capsule" }, "route": { "zh": "口服（固定两成分产品身份字段）", "en": "oral (fixed two-ingredient product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 0078-0405-05", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_capsule", "primaryDisplay": { "zh": "每粒氨氯地平 5 mg＋贝那普利 10 mg；100 粒瓶装", "en": "Amlodipine 5 mg plus benazepril 10 mg per capsule; 100-capsule bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=lotrel-03.jpg&setid=94ae6054-b7ae-4212-a567-4f803af8f2c7", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "氨氯地平", "en": "amlodipine" }, "value": 5, "unit": "mg", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒第一成分标签量；不是个人粒数或换算指令", "en": "labelled amount of the first ingredient per capsule; not an individual capsule count or conversion instruction" } }, { "ingredient": { "zh": "贝那普利", "en": "benazepril" }, "value": 10, "unit": "mg", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒第二成分标签量；不是加用 ACE 抑制剂或换算指令", "en": "labelled amount of the second ingredient per capsule; not an instruction to add an ACE inhibitor or convert products" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-29", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "historical_discontinued_rld", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "physicalClues": { "color": { "zh": "浅棕色胶囊，两条白色环带", "en": "light-brown capsule with two white bands" }, "shape": { "zh": "胶囊，两条白色环带；胶囊外形不代表可自行打开、分装或减半", "en": "capsule with two white bands; capsule form does not establish permission to open, divide or halve it" }, "imprint": "Lotrel; code 2260", "scoreStatus": "capsule_no_split_cue", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_fcdd13243b00d1a0", "label": "DailyMed（NLM）：LOTREL 5/10 mg、NDC 0078-0405-05、100 粒瓶装美国公开标签面板", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=94ae6054-b7ae-4212-a567-4f803af8f2c7", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-lotrel-amlodipine-benazepril-capsule-5-20mg-100-bottle-ndc-0078040605", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（2023-08 修订；2026-08-29 核验）", "en": "Current U.S. DailyMed public label (revised Aug 2023; verified 29 Aug 2026)" }, "dosageForm": { "zh": "LOTREL 氨氯地平/盐酸贝那普利口服胶囊", "en": "LOTREL amlodipine/benazepril hydrochloride oral capsule" }, "route": { "zh": "口服（固定两成分产品身份字段）", "en": "oral (fixed two-ingredient product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 0078-0406-05", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_capsule", "primaryDisplay": { "zh": "每粒氨氯地平 5 mg＋贝那普利 20 mg；100 粒瓶装", "en": "Amlodipine 5 mg plus benazepril 20 mg per capsule; 100-capsule bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=lotrel-04.jpg&setid=94ae6054-b7ae-4212-a567-4f803af8f2c7", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "氨氯地平", "en": "amlodipine" }, "value": 5, "unit": "mg", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒第一成分标签量；不是个人粒数或换算指令", "en": "labelled amount of the first ingredient per capsule; not an individual capsule count or conversion instruction" } }, { "ingredient": { "zh": "贝那普利", "en": "benazepril" }, "value": 20, "unit": "mg", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒第二成分标签量；不是加用 ACE 抑制剂或换算指令", "en": "labelled amount of the second ingredient per capsule; not an instruction to add an ACE inhibitor or convert products" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-29", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "historical_discontinued_rld", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "physicalClues": { "color": { "zh": "粉红色胶囊，两条白色环带", "en": "pink capsule with two white bands" }, "shape": { "zh": "胶囊，两条白色环带；胶囊外形不代表可自行打开、分装或减半", "en": "capsule with two white bands; capsule form does not establish permission to open, divide or halve it" }, "imprint": "Lotrel; code 2265", "scoreStatus": "capsule_no_split_cue", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_fcdd13243b00d1a0", "label": "DailyMed（NLM）：LOTREL 5/20 mg、NDC 0078-0406-05、100 粒瓶装美国公开标签面板", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=94ae6054-b7ae-4212-a567-4f803af8f2c7", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-lotrel-amlodipine-benazepril-capsule-10-20mg-100-bottle-ndc-0078036405", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（2023-08 修订；2026-08-29 核验）", "en": "Current U.S. DailyMed public label (revised Aug 2023; verified 29 Aug 2026)" }, "dosageForm": { "zh": "LOTREL 氨氯地平/盐酸贝那普利口服胶囊", "en": "LOTREL amlodipine/benazepril hydrochloride oral capsule" }, "route": { "zh": "口服（固定两成分产品身份字段）", "en": "oral (fixed two-ingredient product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 0078-0364-05", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_capsule", "primaryDisplay": { "zh": "每粒氨氯地平 10 mg＋贝那普利 20 mg；100 粒瓶装", "en": "Amlodipine 10 mg plus benazepril 20 mg per capsule; 100-capsule bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=lotrel-05.jpg&setid=94ae6054-b7ae-4212-a567-4f803af8f2c7", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "氨氯地平", "en": "amlodipine" }, "value": 10, "unit": "mg", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒第一成分标签量；不是个人粒数或换算指令", "en": "labelled amount of the first ingredient per capsule; not an individual capsule count or conversion instruction" } }, { "ingredient": { "zh": "贝那普利", "en": "benazepril" }, "value": 20, "unit": "mg", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒第二成分标签量；不是加用 ACE 抑制剂或换算指令", "en": "labelled amount of the second ingredient per capsule; not an instruction to add an ACE inhibitor or convert products" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-29", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "historical_discontinued_rld", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "physicalClues": { "color": { "zh": "紫色至紫晶色胶囊，两条白色环带", "en": "purple to amethyst capsule with two white bands" }, "shape": { "zh": "胶囊，两条白色环带；胶囊外形不代表可自行打开、分装或减半", "en": "capsule with two white bands; capsule form does not establish permission to open, divide or halve it" }, "imprint": "Lotrel; code 0364", "scoreStatus": "capsule_no_split_cue", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_fcdd13243b00d1a0", "label": "DailyMed（NLM）：LOTREL 10/20 mg、NDC 0078-0364-05、100 粒瓶装美国公开标签面板", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=94ae6054-b7ae-4212-a567-4f803af8f2c7", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-lotrel-amlodipine-benazepril-capsule-10-40mg-100-bottle-ndc-0078037905", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（2023-08 修订；2026-08-29 核验）", "en": "Current U.S. DailyMed public label (revised Aug 2023; verified 29 Aug 2026)" }, "dosageForm": { "zh": "LOTREL 氨氯地平/盐酸贝那普利口服胶囊", "en": "LOTREL amlodipine/benazepril hydrochloride oral capsule" }, "route": { "zh": "口服（固定两成分产品身份字段）", "en": "oral (fixed two-ingredient product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 0078-0379-05", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_capsule", "primaryDisplay": { "zh": "每粒氨氯地平 10 mg＋贝那普利 40 mg；100 粒瓶装", "en": "Amlodipine 10 mg plus benazepril 40 mg per capsule; 100-capsule bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=lotrel-06.jpg&setid=94ae6054-b7ae-4212-a567-4f803af8f2c7", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "氨氯地平", "en": "amlodipine" }, "value": 10, "unit": "mg", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒第一成分标签量；不是个人粒数或换算指令", "en": "labelled amount of the first ingredient per capsule; not an individual capsule count or conversion instruction" } }, { "ingredient": { "zh": "贝那普利", "en": "benazepril" }, "value": 40, "unit": "mg", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒第二成分标签量；不是加用 ACE 抑制剂或换算指令", "en": "labelled amount of the second ingredient per capsule; not an instruction to add an ACE inhibitor or convert products" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-29", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "historical_discontinued_rld", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "physicalClues": { "color": { "zh": "深蓝色胶囊，两条白色环带", "en": "dark-blue capsule with two white bands" }, "shape": { "zh": "胶囊，两条白色环带；胶囊外形不代表可自行打开、分装或减半", "en": "capsule with two white bands; capsule form does not establish permission to open, divide or halve it" }, "imprint": "Lotrel; code 0379", "scoreStatus": "capsule_no_split_cue", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_fcdd13243b00d1a0", "label": "DailyMed（NLM）：LOTREL 10/40 mg、NDC 0078-0379-05、100 粒瓶装美国公开标签面板", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=94ae6054-b7ae-4212-a567-4f803af8f2c7", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-lotrel-amlodipine-benazepril-capsule-5-10mg-100-bottle-ndc-0078040505", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=lotrel-03.jpg&setid=94ae6054-b7ae-4212-a567-4f803af8f2c7", "alt": { "zh": "DailyMed LOTREL 5/10 mg、NDC 0078-0405-05、100 粒瓶装公开标签面板", "en": "DailyMed LOTREL 5/10 mg, NDC 0078-0405-05, 100-capsule bottle public-label panel" }, "archiveMarket": "美国", "labelVersion": "DailyMed 美国公开品牌标签（2023-08 修订）", "presentation": "LOTREL 氨氯地平 5 mg/贝那普利 10 mg 每粒，NDC 0078-0405-05，100 粒瓶装。", "notice": "此图只对应公开标签中的 LOTREL 5/10 mg、NDC 0078-0405-05、100 粒瓶装面板；不能代表另三个面板、已停止销售的其他历史规格、其他市场或仿制药，不用于鉴定真伪，也不证明当前库存、个人粒数或可替代性。", "source": { "id": "src_fcdd13243b00d1a0", "label": "DailyMed（NLM）：LOTREL 5/10 mg、NDC 0078-0405-05、100 粒瓶装美国公开标签面板", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=94ae6054-b7ae-4212-a567-4f803af8f2c7", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "LOTREL 说明书放大阅读：一粒已有两种降压成分，先排查氨氯地平与 ACE 抑制剂重复", "en": "LOTREL label reading: one capsule already contains two blood-pressure ingredients; check duplicate amlodipine and ACE inhibitors first" }, "summary": { "zh": "LOTREL 每粒固定含氨氯地平和贝那普利。例如 10/20 mg 表示同一粒内分别含 10 mg 与 20 mg；不能把它理解为半粒、两粒、可打开分装或能与其他产品直接相加换算。", "en": "Each LOTREL capsule contains fixed amounts of amlodipine and benazepril. For example, 10/20 mg means 10 mg and 20 mg of the two ingredients in one capsule; it is not a half-capsule cue, a two-capsule cue, permission to open and divide it, or a sum that can be directly converted across products." }, "checks": [ { "zh": "逐盒核对有效成分。NORVASC 是单方氨氯地平；LOTENSIN 是单方贝那普利；ZESTRIL、VASOTEC、ALTACE、CAPOTEN 也是 ACE 抑制剂。若与 LOTREL 同时出现在药单，不要自行加上、删掉或轮换任何一盒，应让药师或开方团队结合完整处方判断。", "en": "Check the active ingredients on every pack. NORVASC is amlodipine alone, LOTENSIN is benazepril alone, and ZESTRIL, VASOTEC, ALTACE and CAPOTEN are also ACE inhibitors. If they appear with LOTREL, do not add, remove or alternate any pack yourself; a pharmacist or prescriber must review the complete prescriptions." }, { "zh": "ENTRESTO 含沙库巴曲/缬沙坦。当前 LOTREL 标签把与奈普利酶抑制剂合用列为禁忌，并规定 ACE 抑制剂切换前后 36 小时边界；网页不据此安排个人停药或换药，应立即联系开方团队或药师核对。", "en": "ENTRESTO contains sacubitril/valsartan. The current LOTREL label contraindicates coadministration with a neprilysin inhibitor and states a 36-hour boundary around switching an ACE inhibitor. The site does not use this to arrange an individual's stopping or switching; contact the prescriber or pharmacist promptly for review." }, { "zh": "面部、眼睑、嘴唇、舌头或咽喉肿胀，吞咽或呼吸困难，可能是血管性水肿；应立即使用当地急救服务，不要等待网页判断。", "en": "Swelling of the face, eyelids, lips, tongue or throat, or difficulty swallowing or breathing, may be angioedema and requires local emergency services immediately. Do not wait for a website assessment." }, { "zh": "老人或体弱者若出现明显头晕、晕厥、跌倒、尿量减少、持续呕吐或腹泻，应及时联系医疗团队；严重、突然或伴意识异常时使用当地急救服务。应结合血压、肾功能、肝功能、钾和完整药单复核，网页不按年龄自动给方案。", "en": "Older or frail adults with marked dizziness, fainting, a fall, reduced urine or persistent vomiting or diarrhoea should contact the care team promptly; use local emergency services for severe or sudden symptoms or altered consciousness. Review blood pressure, kidney and liver function, potassium and the full medicine list; the site does not generate a regimen from age." }, { "zh": "不要自行使用含钾补充剂或含钾代盐。布洛芬或萘普生等 NSAID、锂盐、其他肾素-血管紧张素系统药物、阿利吉仑，以及其他降压药都需要按完整药单复核；糖尿病患者合用阿利吉仑属于标签禁忌边界。", "en": "Do not use potassium supplements or potassium-containing salt substitutes without professional review. NSAIDs such as ibuprofen or naproxen, lithium, other renin-angiotensin-system medicines, aliskiren and other blood-pressure medicines require full-list review; aliskiren coadministration in diabetes is a labelled contraindication boundary." }, { "zh": "当前标签把与氨氯地平合用时辛伐他汀每日上限写为 20 mg。网页不据此改变个人剂量；若药单有辛伐他汀，应让药师或开方团队核对准确产品与处方。", "en": "The current label limits simvastatin to 20 mg daily when used with amlodipine. The site does not change an individual's dose from this statement; if simvastatin is on the medicine list, have the exact product and prescription reviewed by a pharmacist or prescriber." }, { "zh": "标签有胎儿毒性黑框警示。已经怀孕、可能怀孕或计划怀孕者应立即联系开方团队核对，不要等待网页判断，也不要自行安排停换药。", "en": "The label carries a boxed warning for fetal toxicity. Anyone who is pregnant, may be pregnant or plans pregnancy should contact the prescribing team promptly; do not wait for a website decision or arrange stopping or switching independently." } ], "source": { "id": "src_fcdd13243b00d1a0", "label": "DailyMed（NLM）：LOTREL 氨氯地平/盐酸贝那普利当前美国公开标签（2023-08 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=94ae6054-b7ae-4212-a567-4f803af8f2c7", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "两种成分怎样协同：氨氯地平帮助血管舒张，贝那普利减少血管紧张素 II 形成", "en": "How the two ingredients work together: amlodipine supports arterial relaxation and benazepril reduces angiotensin II formation" }, "summary": { "zh": "当前标签说明：氨氯地平是二氢吡啶类钙通道阻滞剂，抑制钙离子跨膜进入血管平滑肌并产生外周动脉舒张；贝那普利转化为贝那普利拉，抑制血管紧张素转换酶，减少血管紧张素 II 和醛固酮相关作用。两条路径放在同一粒胶囊中，不表示网页能按血压数字拆分或重组个人方案。", "en": "The current label explains that amlodipine is a dihydropyridine calcium-channel blocker that inhibits transmembrane calcium influx into vascular smooth muscle and produces peripheral arterial vasodilation. Benazepril is converted to benazeprilat, which inhibits angiotensin-converting enzyme and reduces angiotensin II- and aldosterone-related effects. Combining both paths in one capsule does not let the site split or rebuild an individual's regimen from a blood-pressure number." }, "checks": [ { "zh": "氨氯地平成分可能与水肿、头晕或低血压有关；贝那普利成分可能影响钾和肾功能。不能只看“降压”两个字而忽略症状、化验和完整药单。", "en": "Amlodipine may be associated with oedema, dizziness or hypotension, while benazepril may affect potassium and kidney function. The words 'blood pressure' must not replace symptoms, laboratory review and the complete medicine list." }, { "zh": "四组双数字是四种完整标签产品身份。不同 mg 组合、颜色、印字和 NDC 不能由网页转换成个人加量、减量、打开胶囊、补服或交替使用。", "en": "The four paired strengths are four complete labelled product identities. Different milligram pairs, colours, imprints and NDCs cannot be converted by the site into an individual increase, decrease, capsule opening, make-up use or alternation plan." }, { "zh": "老人、体弱者或存在肾功能、肝功能、水分不足等情况时，更需要专业人员结合实际药盒与监测结果复核；公开标签仍可阅读不等于该品牌当前可得。", "en": "Older or frail adults and people with kidney or liver impairment or volume depletion particularly need professional review using the actual packs and monitoring results. A publicly readable label does not mean that the brand is currently available." } ], "source": { "id": "src_fcdd13243b00d1a0", "label": "DailyMed（NLM）：LOTREL 氨氯地平/盐酸贝那普利当前美国公开标签（2023-08 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=94ae6054-b7ae-4212-a567-4f803af8f2c7", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "LOTREL", "generic": "氨氯地平/盐酸贝那普利胶囊", "dosageFormClass": "氨氯地平/盐酸贝那普利固定两成分口服胶囊：当前公开标签列示 5/10、5/20、10/20、10/40 mg；每组两个数字属于同一粒胶囊内两种成分" }, "labelSource": { "id": "src_fcdd13243b00d1a0", "label": "DailyMed（NLM）：LOTREL 氨氯地平/盐酸贝那普利当前美国公开标签（2023-08 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=94ae6054-b7ae-4212-a567-4f803af8f2c7", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "productRoutes": [ { "source": { "id": "src_fcdd13243b00d1a0", "label": "DailyMed（NLM）：LOTREL 氨氯地平/盐酸贝那普利当前美国公开标签（2023-08 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=94ae6054-b7ae-4212-a567-4f803af8f2c7", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-29", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_10e511bf83430e3b", "label": "FDA/openFDA Orange Book 当前数据：LOTREL，NDA 020364，六个历史 RLD 规格均列为 Discontinued", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-08-29", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_64c97139855a59cd", "label": "FDA/openFDA Drugs@FDA 当前数据：LOTREL NDA 020364 原始批准、申请持有人与六个已停止销售产品记录", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=020364", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-08-29", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-29", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "LOTREL 一粒同时含氨氯地平和贝那普利。药盒上的 5/10、5/20、10/20 或 10/40 不是分粒、半粒或两粒的算式，而是同一粒胶囊内两种成分各有多少毫克。若药单还有 NORVASC 或其他氨氯地平，以及 ZESTRIL、VASOTEC、ALTACE、CAPOTEN 等 ACE 抑制剂，或出现 ENTRESTO，应带所有药盒让药师或开方团队核对成分重复与特殊切换边界，不要自行加药、停药、打开胶囊或轮换。FDA 当前记录将 LOTREL 六个历史 RLD 规格均列为已停止销售。", "history": "FDA Drugs@FDA 当前数据记录 LOTREL NDA 020364 于 1995-03-03 获原始批准，属于新复方；2020-02-10 有 S-066 补充批准信。DailyMed 当前公开品牌标签为 2023-08 修订。FDA Orange Book 与 Drugs@FDA 2026-08-28 数据将 2.5/10、5/10、5/20、10/20、10/40、5/40 mg 六个历史规格均列为 RLD、RS 为 No、Marketing Status 为 Discontinued；当前公开标签只列示其中四个规格与四个 100 粒瓶装面板。", "sourceDocuments": [ { "id": "src_fcdd13243b00d1a0", "label": "DailyMed（NLM）：LOTREL 氨氯地平/盐酸贝那普利当前美国公开标签（2023-08 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=94ae6054-b7ae-4212-a567-4f803af8f2c7", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, { "id": "src_10e511bf83430e3b", "label": "FDA/openFDA Orange Book 当前数据：LOTREL，NDA 020364，六个历史 RLD 规格均列为 Discontinued", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, { "id": "src_64c97139855a59cd", "label": "FDA/openFDA Drugs@FDA 当前数据：LOTREL NDA 020364 原始批准、申请持有人与六个已停止销售产品记录", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=020364", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, { "id": "src_ff49e4565bc0f1d2", "label": "FDA：LOTREL NDA 020364/S-066 补充批准信（2020-02-10）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/020364Orig1s066ltr.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_regulatory_record", "documentKind": "approval_letter", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_pdf", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } ], "applicationNumber": "FDA NDA 020364（LOTREL / amlodipine and benazepril hydrochloride oral capsules）", "approvalTimeline": [ { "date": "1995-03-03", "title": { "zh": "LOTREL 原始批准", "en": "Original LOTREL approval" }, "detail": { "zh": "Drugs@FDA 当前数据记录 NDA 020364 原始批准，审评分类为新复方。", "en": "Current Drugs@FDA data record the original approval of NDA 020364 as a new combination." }, "source": { "id": "src_64c97139855a59cd", "label": "FDA/openFDA Drugs@FDA 当前数据：LOTREL NDA 020364 原始批准、申请持有人与六个已停止销售产品记录", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=020364", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } }, { "date": "2020-02-10", "title": { "zh": "S-066 补充批准", "en": "S-066 supplemental approval" }, "detail": { "zh": "FDA 公开补充批准信记录标签更新节点；它不证明当前市场供应。", "en": "The FDA public supplemental approval letter records a labelling milestone; it does not establish current market supply." }, "source": { "id": "src_ff49e4565bc0f1d2", "label": "FDA：LOTREL NDA 020364/S-066 补充批准信（2020-02-10）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/020364Orig1s066ltr.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_regulatory_record", "documentKind": "approval_letter", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_pdf", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } }, { "date": "2023-08-01", "title": { "zh": "当前公开品牌标签修订", "en": "Current public brand label revised" }, "detail": { "zh": "DailyMed 当前页面列示四个规格、四个准确 100 粒瓶装面板及放大安全信息。", "en": "The current DailyMed page lists four strengths, four exact 100-capsule bottle panels and enlarged safety information." }, "source": { "id": "src_fcdd13243b00d1a0", "label": "DailyMed（NLM）：LOTREL 氨氯地平/盐酸贝那普利当前美国公开标签（2023-08 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=94ae6054-b7ae-4212-a567-4f803af8f2c7", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } }, { "date": "2026-08-28", "title": { "zh": "当前 FDA 数据状态核验", "en": "Current FDA data status reviewed" }, "detail": { "zh": "Orange Book 与 Drugs@FDA 数据将 NDA 020364 六个历史规格均列为 RLD、RS 为 No、Discontinued。", "en": "Orange Book and Drugs@FDA data list all six historical NDA 020364 strengths as RLD products, RS No and Discontinued." }, "source": { "id": "src_10e511bf83430e3b", "label": "FDA/openFDA Orange Book 当前数据：LOTREL，NDA 020364，六个历史 RLD 规格均列为 Discontinued", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "六个历史 RLD 规格当前均列为 Discontinued；四个有日期品牌标签面板可公开阅读", "en": "All six historical RLD strengths are currently listed as Discontinued; four dated brand-label panels remain publicly readable" }, "detail": { "zh": "公开标签用于核对成分、规格、包装、外观和安全信息，不证明药房库存、购买资格或可替代性。", "en": "The public label supports review of ingredients, strengths, packs, appearance and safety information; it does not establish pharmacy stock, purchasing eligibility or interchangeability." } }, { "market": { "zh": "中国大陆及其他市场", "en": "Mainland China and other markets" }, "status": { "zh": "待逐项建立现行市场记录", "en": "Current market record not established" }, "detail": { "zh": "不从美国历史品牌、共同成分或 mg 数字推定当地批准、商品名、包装、供应或可替代性。", "en": "No local approval, trade name, pack, supply or interchangeability is inferred from the historical U.S. brand, shared ingredients or milligram numbers." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "10/20 mg 是不是把胶囊减半或吃两粒？", "en": "Does 10/20 mg mean half a capsule or two capsules?" }, "answer": { "zh": "都不是。它表示同一粒胶囊内有氨氯地平 10 mg 和贝那普利 20 mg。网页不会把双数字转换为打开胶囊、分装、减半或个人粒数。", "en": "Neither. It means one capsule contains amlodipine 10 mg and benazepril 20 mg. The site does not convert the paired numbers into opening, dividing, halving or an individual capsule count." } }, { "question": { "zh": "胶囊可以打开，倒出一半就等于减量吗？", "en": "Can the capsule be opened and half the contents used to reduce the amount?" }, "answer": { "zh": "不能从胶囊外形或毫克数字得出这个结论。当前公开标签建立的是完整胶囊产品身份，并没有让网页据此提供打开、分装或减半方案；应按准确药瓶、处方和药师或开方团队意见核对。", "en": "That conclusion cannot be drawn from capsule form or milligram numbers. The current public label establishes an intact capsule product identity and does not allow the site to provide an opening, dividing or halving plan. Check the exact bottle, prescription and pharmacist or prescriber advice." } }, { "question": { "zh": "已经吃 LOTREL，还能再吃 NORVASC 或其他 ACE 抑制剂吗？", "en": "Can NORVASC or another ACE inhibitor be taken in addition to LOTREL?" }, "answer": { "zh": "网页不能替个人决定。LOTREL 已含氨氯地平和 ACE 抑制剂贝那普利，另一个同成分或同类产品可能是重复，也可能是专业人员有意安排；只有准确处方、实际药盒和完整药单才能判断。不要自行加上或停掉任何一盒。", "en": "The site cannot decide for an individual. LOTREL already contains amlodipine and the ACE inhibitor benazepril; another same-ingredient or same-class product may be duplicative or intentionally prescribed. Only exact prescriptions, packs and the complete medicine list can establish that. Do not add or stop a pack yourself." } }, { "question": { "zh": "为什么标签还能打开，FDA 却写着 Discontinued？", "en": "Why is the label still readable when FDA data say Discontinued?" }, "answer": { "zh": "公开标签是监管与安全信息档案，不等于实时供应清单。当前 FDA 数据对六个历史 RLD 产品的市场状态为 Discontinued，因此页面不会把可阅读标签写成当前有货。", "en": "A public label is a regulatory and safety-information record, not a live supply list. Current FDA data list all six historical RLD products as Discontinued, so this page does not present a readable label as current availability." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "how-to-read-a-drug-label", "dosage-forms-are-part-of-medicine-identity" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/lotrel/", "en": "https://origindrug.com/en/drugs/lotrel/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "azor", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-29", "status": "published_traceable_archive" }, "names": { "brand": "AZOR", "generic": "氨氯地平/奥美沙坦酯片", "aliases": [ "Azor", "amlodipine olmesartan", "amlodipine and olmesartan medoxomil", "amlodipine/olmesartan", "氨氯地平奥美沙坦", "氨氯地平奥美沙坦酯片", "氨氯地平/奥美沙坦酯", "NDA 022100", "0713-0870-30", "0713-0871-30", "0713-0872-30", "0713-0873-30", "AZOR C73", "AZOR C74", "AZOR C75", "AZOR C77" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "心血管", "sourceArchiveMarket": "美国：DailyMed 当前 AZOR 标签（2023-07-12 更新）列示氨氯地平/奥美沙坦酯薄膜衣口服片、四个规格及四个准确 30 片瓶装面板；FDA Orange Book 2026-08-28 数据将 NDA 022100 四个规格均列为处方 RLD，10/40 mg 同时列为 RS。页面不由此推定实时库存、购买资格、其他市场包装或可替代性。", "dosageFormClass": "氨氯地平/奥美沙坦酯固定两成分薄膜衣口服片：5/20、10/20、5/40、10/40 mg；每组两个数字属于同一片内两种成分", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "2007", "archiveSponsorText": "Cosette Pharmaceuticals, Inc.（FDA 当前申请与 DailyMed 标签记录）" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [ "NORVASC", "amlodipine tablet", "BENICAR", "olmesartan medoxomil tablet", "BENICAR HCT", "TRIBENZOR", "LOTREL", "EXFORGE", "CADUET" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-azor-amlodipine-olmesartan-tablet-5-20mg-30-bottle-ndc-0713087030", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（2023-07-12 更新；2026-08-29 核验）", "en": "Current U.S. DailyMed public label (updated 12 Jul 2023; verified 29 Aug 2026)" }, "dosageForm": { "zh": "AZOR 氨氯地平/奥美沙坦酯薄膜衣口服片", "en": "AZOR amlodipine/olmesartan medoxomil film-coated oral tablet" }, "route": { "zh": "口服（固定两成分产品身份字段）", "en": "oral (fixed two-ingredient product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 0713-0870-30", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片氨氯地平 5 mg＋奥美沙坦酯 20 mg；30 片瓶装", "en": "Amlodipine 5 mg plus olmesartan medoxomil 20 mg per tablet; 30-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=azor-07.jpg&setid=c5535406-b63b-49aa-88b9-169aaf0ed08e", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "氨氯地平", "en": "amlodipine" }, "value": 5, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片第一成分标签量；不是个人片数或换算指令", "en": "labelled amount of the first ingredient per tablet; not an individual tablet count or conversion instruction" } }, { "ingredient": { "zh": "奥美沙坦酯", "en": "olmesartan medoxomil" }, "value": 20, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片第二成分标签量；不是加用另一种降压药或换算指令", "en": "labelled amount of the second ingredient per tablet; not an instruction to add another blood-pressure medicine or convert products" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "塑料瓶", "en": "plastic bottle" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-29", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "current_regulatory_listing_not_inventory", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 30, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "白色", "en": "white" }, "shape": { "zh": "圆形、无刻痕薄膜衣片，约 6 mm；无刻痕不表示可自行掰开或磨碎", "en": "round, unscored film-coated tablet, approximately 6 mm; an unscored tablet does not establish permission to split or crush it" }, "imprint": "C73", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_2b3b81afaa97f32b", "label": "DailyMed（NLM）：AZOR 5/20 mg、NDC 0713-0870-30、30 片瓶装美国公开标签面板", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=c5535406-b63b-49aa-88b9-169aaf0ed08e", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-azor-amlodipine-olmesartan-tablet-10-20mg-30-bottle-ndc-0713087130", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（2023-07-12 更新；2026-08-29 核验）", "en": "Current U.S. DailyMed public label (updated 12 Jul 2023; verified 29 Aug 2026)" }, "dosageForm": { "zh": "AZOR 氨氯地平/奥美沙坦酯薄膜衣口服片", "en": "AZOR amlodipine/olmesartan medoxomil film-coated oral tablet" }, "route": { "zh": "口服（固定两成分产品身份字段）", "en": "oral (fixed two-ingredient product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 0713-0871-30", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片氨氯地平 10 mg＋奥美沙坦酯 20 mg；30 片瓶装", "en": "Amlodipine 10 mg plus olmesartan medoxomil 20 mg per tablet; 30-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=azor-08.jpg&setid=c5535406-b63b-49aa-88b9-169aaf0ed08e", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "氨氯地平", "en": "amlodipine" }, "value": 10, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片第一成分标签量；不是个人片数或换算指令", "en": "labelled amount of the first ingredient per tablet; not an individual tablet count or conversion instruction" } }, { "ingredient": { "zh": "奥美沙坦酯", "en": "olmesartan medoxomil" }, "value": 20, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片第二成分标签量；不是加用另一种降压药或换算指令", "en": "labelled amount of the second ingredient per tablet; not an instruction to add another blood-pressure medicine or convert products" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "塑料瓶", "en": "plastic bottle" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-29", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "current_regulatory_listing_not_inventory", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 30, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "灰橙色", "en": "grayish orange" }, "shape": { "zh": "圆形、无刻痕薄膜衣片，约 8 mm；无刻痕不表示可自行掰开或磨碎", "en": "round, unscored film-coated tablet, approximately 8 mm; an unscored tablet does not establish permission to split or crush it" }, "imprint": "C74", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_2b3b81afaa97f32b", "label": "DailyMed（NLM）：AZOR 10/20 mg、NDC 0713-0871-30、30 片瓶装美国公开标签面板", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=c5535406-b63b-49aa-88b9-169aaf0ed08e", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-azor-amlodipine-olmesartan-tablet-5-40mg-30-bottle-ndc-0713087230", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（2023-07-12 更新；2026-08-29 核验）", "en": "Current U.S. DailyMed public label (updated 12 Jul 2023; verified 29 Aug 2026)" }, "dosageForm": { "zh": "AZOR 氨氯地平/奥美沙坦酯薄膜衣口服片", "en": "AZOR amlodipine/olmesartan medoxomil film-coated oral tablet" }, "route": { "zh": "口服（固定两成分产品身份字段）", "en": "oral (fixed two-ingredient product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 0713-0872-30", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片氨氯地平 5 mg＋奥美沙坦酯 40 mg；30 片瓶装", "en": "Amlodipine 5 mg plus olmesartan medoxomil 40 mg per tablet; 30-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=azor-09.jpg&setid=c5535406-b63b-49aa-88b9-169aaf0ed08e", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "氨氯地平", "en": "amlodipine" }, "value": 5, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片第一成分标签量；不是个人片数或换算指令", "en": "labelled amount of the first ingredient per tablet; not an individual tablet count or conversion instruction" } }, { "ingredient": { "zh": "奥美沙坦酯", "en": "olmesartan medoxomil" }, "value": 40, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片第二成分标签量；不是加用另一种降压药或换算指令", "en": "labelled amount of the second ingredient per tablet; not an instruction to add another blood-pressure medicine or convert products" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "塑料瓶", "en": "plastic bottle" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-29", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "current_regulatory_listing_not_inventory", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 30, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "乳白色", "en": "cream" }, "shape": { "zh": "圆形、无刻痕薄膜衣片，约 8 mm；无刻痕不表示可自行掰开或磨碎", "en": "round, unscored film-coated tablet, approximately 8 mm; an unscored tablet does not establish permission to split or crush it" }, "imprint": "C75", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_2b3b81afaa97f32b", "label": "DailyMed（NLM）：AZOR 5/40 mg、NDC 0713-0872-30、30 片瓶装美国公开标签面板", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=c5535406-b63b-49aa-88b9-169aaf0ed08e", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-azor-amlodipine-olmesartan-tablet-10-40mg-30-bottle-ndc-0713087330", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（2023-07-12 更新；2026-08-29 核验）", "en": "Current U.S. DailyMed public label (updated 12 Jul 2023; verified 29 Aug 2026)" }, "dosageForm": { "zh": "AZOR 氨氯地平/奥美沙坦酯薄膜衣口服片", "en": "AZOR amlodipine/olmesartan medoxomil film-coated oral tablet" }, "route": { "zh": "口服（固定两成分产品身份字段）", "en": "oral (fixed two-ingredient product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 0713-0873-30", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片氨氯地平 10 mg＋奥美沙坦酯 40 mg；30 片瓶装", "en": "Amlodipine 10 mg plus olmesartan medoxomil 40 mg per tablet; 30-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=azor-0a.jpg&setid=c5535406-b63b-49aa-88b9-169aaf0ed08e", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "氨氯地平", "en": "amlodipine" }, "value": 10, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片第一成分标签量；不是个人片数或换算指令", "en": "labelled amount of the first ingredient per tablet; not an individual tablet count or conversion instruction" } }, { "ingredient": { "zh": "奥美沙坦酯", "en": "olmesartan medoxomil" }, "value": 40, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片第二成分标签量；不是加用另一种降压药或换算指令", "en": "labelled amount of the second ingredient per tablet; not an instruction to add another blood-pressure medicine or convert products" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "塑料瓶", "en": "plastic bottle" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-29", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "current_regulatory_listing_not_inventory", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 30, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "棕红色", "en": "brownish red" }, "shape": { "zh": "圆形、无刻痕薄膜衣片，约 8 mm；无刻痕不表示可自行掰开或磨碎", "en": "round, unscored film-coated tablet, approximately 8 mm; an unscored tablet does not establish permission to split or crush it" }, "imprint": "C77", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_2b3b81afaa97f32b", "label": "DailyMed（NLM）：AZOR 10/40 mg、NDC 0713-0873-30、30 片瓶装美国公开标签面板", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=c5535406-b63b-49aa-88b9-169aaf0ed08e", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-azor-amlodipine-olmesartan-tablet-5-20mg-30-bottle-ndc-0713087030", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=azor-07.jpg&setid=c5535406-b63b-49aa-88b9-169aaf0ed08e", "alt": { "zh": "DailyMed 当前 AZOR 5/20 mg、NDC 0713-0870-30、30 片瓶装标签面板", "en": "Current DailyMed AZOR 5/20 mg, NDC 0713-0870-30, 30-tablet bottle label panel" }, "archiveMarket": "美国", "labelVersion": "DailyMed 美国当前公开标签（2023-07-12 更新）", "presentation": "AZOR 氨氯地平 5 mg/奥美沙坦酯 20 mg 每片，NDC 0713-0870-30，30 片瓶装。", "notice": "此图只对应当前标签中的 AZOR 5/20 mg、NDC 0713-0870-30、30 片瓶装面板；不能代表另三个规格、其他市场或仿制药，不用于鉴定真伪，也不证明实时库存、个人片数或可替代性。", "source": { "id": "src_2b3b81afaa97f32b", "label": "DailyMed（NLM）：AZOR 5/20 mg、NDC 0713-0870-30、30 片瓶装美国公开标签面板", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=c5535406-b63b-49aa-88b9-169aaf0ed08e", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "AZOR 说明书放大阅读：一片已有两种降压成分，先核对氨氯地平和奥美沙坦是否重复", "en": "AZOR label reading: one tablet already contains two blood-pressure ingredients; first check duplicate amlodipine and olmesartan" }, "summary": { "zh": "AZOR 每片固定含氨氯地平和奥美沙坦酯。例如 10/40 mg 表示同一片内分别含 10 mg 与 40 mg；不能理解成两片、半片或可与单方产品直接相加换算。", "en": "Each AZOR tablet contains fixed amounts of amlodipine and olmesartan medoxomil. For example, 10/40 mg means 10 mg and 40 mg of the two ingredients in one tablet; it is not a two-tablet cue, a half-tablet cue or a sum that can be directly converted with single-ingredient products." }, "checks": [ { "zh": "逐盒看有效成分。NORVASC 是单方氨氯地平，BENICAR 是单方奥美沙坦酯；LOTREL、EXFORGE、CADUET、BENICAR HCT 和 TRIBENZOR 可能与 AZOR 共享一种成分。若同时出现在药单，不要自行删掉或加上任何一盒，应由药师或开方团队结合完整处方判断。", "en": "Read the active ingredients on every pack. NORVASC is amlodipine alone and BENICAR is olmesartan medoxomil alone; LOTREL, EXFORGE, CADUET, BENICAR HCT and TRIBENZOR may share an ingredient with AZOR. If they appear together, do not add or remove a pack yourself; a pharmacist or prescriber must review the complete prescriptions." }, { "zh": "标签有胎儿毒性黑框警示。已经怀孕、可能怀孕或计划怀孕者应立即联系开方团队核对；不要等待网页判断，也不要自行安排停换药。", "en": "The label carries a boxed warning for fetal toxicity. Anyone who is pregnant, may be pregnant or plans pregnancy should contact the prescribing team promptly; do not wait for a website decision or arrange stopping or switching independently." }, { "zh": "严重、持续的慢性腹泻并伴明显体重下降，可能与标签所述类乳糜泻性肠病有关，即使已使用数月或数年也应尽快联系医疗团队；若出现脱水、晕厥、意识异常或无法进水，使用当地急救服务。", "en": "Severe, persistent chronic diarrhoea with substantial weight loss may relate to the labelled sprue-like enteropathy, even after months or years of use, and warrants prompt contact with the care team. Use local emergency services for dehydration, fainting, altered consciousness or inability to take fluids." }, { "zh": "老人或体弱者若明显头晕、晕厥、跌倒、尿量减少或持续呕吐腹泻，应及时联系医疗团队；严重或突然时使用当地急救服务。应结合血压、肾功能、肝功能、电解质与完整药单复核，网页不按年龄生成方案。", "en": "Older or frail adults with marked dizziness, fainting, a fall, reduced urine or persistent vomiting or diarrhoea should contact the care team promptly; use local emergency services for severe or sudden symptoms. Review blood pressure, kidney and liver function, electrolytes and the full medicine list; the site does not generate a regimen from age." }, { "zh": "标签注明：糖尿病患者合用阿利吉仑属于禁忌边界。其他肾素-血管紧张素系统药物、NSAID（如布洛芬或萘普生）、锂盐、含钾补充剂或代盐，以及胆汁酸螯合剂考来维仑都需要按准确产品和完整药单核对；网页不安排个人间隔或停换药。", "en": "The label contraindicates aliskiren coadministration in patients with diabetes. Other renin-angiotensin-system medicines, NSAIDs such as ibuprofen or naproxen, lithium, potassium supplements or salt substitutes, and the bile-acid sequestrant colesevelam require exact-product and full-list review. The site does not arrange an individual's interval, stopping or switching." }, { "zh": "当前标签把与氨氯地平合用时辛伐他汀每日上限写为 20 mg。网页不据此改变个人剂量；若药单有辛伐他汀，应让药师或开方团队核对准确产品与处方。", "en": "The current label limits simvastatin to 20 mg daily when used with amlodipine. The site does not change an individual's dose from this statement; if simvastatin is on the medicine list, have the exact product and prescription reviewed by a pharmacist or prescriber." }, { "zh": "四种片剂均为薄膜衣、圆形、无刻痕。无刻痕不等于可自行掰开、磨碎或按颜色换药；应按准确处方和药师或开方团队意见核对。", "en": "All four tablets are round, film-coated and unscored. An unscored tablet does not permit self-splitting, crushing or colour-based switching; check the exact prescription with a pharmacist or prescriber." } ], "source": { "id": "src_2b3b81afaa97f32b", "label": "DailyMed（NLM）：AZOR 氨氯地平/奥美沙坦酯当前美国公开标签（2023-07-12 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=c5535406-b63b-49aa-88b9-169aaf0ed08e", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "两种成分怎样协同：氨氯地平帮助血管舒张，奥美沙坦阻断血管紧张素 II 的 AT1 受体作用", "en": "How the two ingredients work together: amlodipine supports arterial relaxation and olmesartan blocks angiotensin II activity at the AT1 receptor" }, "summary": { "zh": "当前标签说明：氨氯地平是二氢吡啶类钙通道阻滞剂，减少钙离子进入血管平滑肌并产生外周动脉舒张；奥美沙坦酯转化为奥美沙坦，选择性阻断血管紧张素 II 与 AT1 受体结合。两条路径放在同一片中，不表示网页能按血压数字拆分或重组个人方案。", "en": "The current label explains that amlodipine is a dihydropyridine calcium-channel blocker that reduces calcium influx into vascular smooth muscle and produces peripheral arterial vasodilation. Olmesartan medoxomil is converted to olmesartan, which selectively blocks angiotensin II binding to the AT1 receptor. Combining both pathways in one tablet does not let the site split or rebuild an individual's regimen from a blood-pressure number." }, "checks": [ { "zh": "氨氯地平成分可能与水肿、头晕或低血压有关；奥美沙坦成分可能影响肾功能和电解质。不能只看“降压”两个字而忽略症状、化验和完整药单。", "en": "Amlodipine may be associated with oedema, dizziness or hypotension, while olmesartan may affect kidney function and electrolytes. The words 'blood pressure' must not replace symptoms, laboratory review and the complete medicine list." }, { "zh": "四组双数字是四种完整标签产品身份。不同 mg 组合、颜色、印字和 NDC 不能由网页转换成个人加量、减量、分片、补服或交替使用。", "en": "The four paired strengths are four complete labelled product identities. Different milligram pairs, colours, imprints and NDCs cannot be converted by the site into an individual increase, decrease, splitting, make-up use or alternation plan." }, { "zh": "当前标签指出，≥75 岁人群的氨氯地平初始量考虑与 AZOR 最低规格之间存在边界；这不是网页给老人停用或改量的指令，而是提醒带准确药盒、监测结果和完整药单让开方团队复核。", "en": "The current label identifies a boundary between amlodipine initiation considerations in people aged 75 years or older and AZOR's lowest strength. This is not a website instruction to stop or change an amount; it prompts review of the exact pack, monitoring results and complete medicine list by the prescribing team." } ], "source": { "id": "src_2b3b81afaa97f32b", "label": "DailyMed（NLM）：AZOR 氨氯地平/奥美沙坦酯当前美国公开标签（2023-07-12 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=c5535406-b63b-49aa-88b9-169aaf0ed08e", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "AZOR", "generic": "氨氯地平/奥美沙坦酯片", "dosageFormClass": "氨氯地平/奥美沙坦酯固定两成分薄膜衣口服片：5/20、10/20、5/40、10/40 mg；每组两个数字属于同一片内两种成分" }, "labelSource": { "id": "src_2b3b81afaa97f32b", "label": "DailyMed（NLM）：AZOR 氨氯地平/奥美沙坦酯当前美国公开标签（2023-07-12 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=c5535406-b63b-49aa-88b9-169aaf0ed08e", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "productRoutes": [ { "source": { "id": "src_2b3b81afaa97f32b", "label": "DailyMed（NLM）：AZOR 氨氯地平/奥美沙坦酯当前美国公开标签（2023-07-12 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=c5535406-b63b-49aa-88b9-169aaf0ed08e", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-29", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_10e511bf83430e3b", "label": "FDA Orange Book 当前数据：AZOR，NDA 022100，四个口服片规格均列为处方 RLD；10/40 mg 同时列为 RS", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-08-29", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_9ddcb06f7196a1e3", "label": "FDA Drugs@FDA 官方检索入口：AZOR NDA 022100 原始批准与申请记录", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-08-29", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-29", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "AZOR 一片同时含氨氯地平和奥美沙坦酯。药盒上的 5/20、10/20、5/40 或 10/40 不是半片、两片或加减法，而是同一片内两种成分各有多少毫克。若药单还有 NORVASC、BENICAR，或 LOTREL、EXFORGE、CADUET、BENICAR HCT、TRIBENZOR 等可能共享成分的产品，应带所有药盒和处方让药师或开方团队逐项核对，不要自行叠加、停药、轮换或按毫克换算。", "history": "FDA 公开审评资料与 Orange Book 记录 AZOR NDA 022100 于 2007-09-26 获批，四个规格均为处方 RLD；当前数据将 10/40 mg 同时列为 RS。DailyMed 当前标签页面于 2023-07-12 更新，四个 NDC 的 30 片瓶装营销起始日期列为 2022-09-01，未列营销结束日期；这仍不是实时库存证明。", "sourceDocuments": [ { "id": "src_2b3b81afaa97f32b", "label": "DailyMed（NLM）：AZOR 氨氯地平/奥美沙坦酯当前美国公开标签（2023-07-12 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=c5535406-b63b-49aa-88b9-169aaf0ed08e", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, { "id": "src_10e511bf83430e3b", "label": "FDA Orange Book 当前数据：AZOR，NDA 022100，四个口服片规格均列为处方 RLD；10/40 mg 同时列为 RS", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, { "id": "src_9ddcb06f7196a1e3", "label": "FDA Drugs@FDA 官方检索入口：AZOR NDA 022100 原始批准与申请记录", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, { "id": "src_e6e3de41afca3ccd", "label": "FDA：AZOR NDA 022100 原始申请行政审评资料（2007）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/022100s000_AdminCorres_P1.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_regulatory_record", "documentKind": "regulatory_review", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_pdf", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } ], "applicationNumber": "FDA NDA 022100（AZOR / amlodipine and olmesartan medoxomil oral tablets）", "approvalTimeline": [ { "date": "2007-09-26", "title": { "zh": "AZOR 原始批准", "en": "Original AZOR approval" }, "detail": { "zh": "FDA 公开审评资料与 Orange Book 当前记录 NDA 022100 的四个固定复方规格获批。", "en": "FDA public review material and current Orange Book data record approval of the four fixed-combination strengths under NDA 022100." }, "source": { "id": "src_e6e3de41afca3ccd", "label": "FDA：AZOR NDA 022100 原始申请行政审评资料（2007）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/022100s000_AdminCorres_P1.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_regulatory_record", "documentKind": "regulatory_review", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_pdf", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } }, { "date": "2022-09-01", "title": { "zh": "当前四个 NDC 标签营销起始日期", "en": "Current label marketing-start date for four NDCs" }, "detail": { "zh": "DailyMed 当前页面对四个 30 片瓶装 NDC 均列 2022-09-01 为营销起始日期且未列结束日期；这不是实时库存证明。", "en": "The current DailyMed page lists 1 Sep 2022 as the marketing-start date for all four 30-tablet bottle NDCs and no end date; this is not real-time stock evidence." }, "source": { "id": "src_2b3b81afaa97f32b", "label": "DailyMed（NLM）：AZOR 氨氯地平/奥美沙坦酯当前美国公开标签（2023-07-12 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=c5535406-b63b-49aa-88b9-169aaf0ed08e", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } }, { "date": "2023-07-12", "title": { "zh": "当前公开标签页面更新", "en": "Current public label page updated" }, "detail": { "zh": "DailyMed 当前页面列示四个规格、四个准确 30 片瓶装面板、外观和放大安全信息。", "en": "The current DailyMed page lists four strengths, four exact 30-tablet bottle panels, appearance and enlarged safety information." }, "source": { "id": "src_2b3b81afaa97f32b", "label": "DailyMed（NLM）：AZOR 氨氯地平/奥美沙坦酯当前美国公开标签（2023-07-12 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=c5535406-b63b-49aa-88b9-169aaf0ed08e", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } }, { "date": "2026-08-28", "title": { "zh": "当前 Orange Book 身份核验", "en": "Current Orange Book identity reviewed" }, "detail": { "zh": "当前数据将四个规格均列为处方 RLD，并将 10/40 mg 列为 RS。", "en": "Current data list all four strengths as prescription RLD products and 10/40 mg as the RS." }, "source": { "id": "src_10e511bf83430e3b", "label": "FDA Orange Book 当前数据：AZOR，NDA 022100，四个口服片规格均列为处方 RLD；10/40 mg 同时列为 RS", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "四个处方 RLD 规格；10/40 mg 同时为 RS；四个当前标签 NDC 无营销结束日期", "en": "Four prescription RLD strengths; 10/40 mg also RS; four current-label NDCs have no marketing end date" }, "detail": { "zh": "这些官方记录支持核对产品身份，不证明药房实时库存、购买资格或可替代性。", "en": "These official records support product-identity review; they do not establish real-time pharmacy stock, purchasing eligibility or interchangeability." } }, { "market": { "zh": "中国大陆及其他市场", "en": "Mainland China and other markets" }, "status": { "zh": "待逐项建立现行市场记录", "en": "Current market record not established" }, "detail": { "zh": "不从美国品牌、共同成分或 mg 数字推定当地批准、商品名、包装、供应或可替代性。", "en": "No local approval, trade name, pack, supply or interchangeability is inferred from the U.S. brand, shared ingredients or milligram numbers." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "10/40 mg 是不是要吃两片，或把一片掰半？", "en": "Does 10/40 mg mean two tablets or half a tablet?" }, "answer": { "zh": "都不是。它表示同一片内有氨氯地平 10 mg 和奥美沙坦酯 40 mg。网页不会把双数字转换为分片、磨碎或个人片数。", "en": "Neither. It means one tablet contains amlodipine 10 mg and olmesartan medoxomil 40 mg. The site does not convert the paired numbers into splitting, crushing or an individual tablet count." } }, { "question": { "zh": "已经吃 AZOR，还能再吃 NORVASC 或 BENICAR 吗？", "en": "Can NORVASC or BENICAR be taken in addition to AZOR?" }, "answer": { "zh": "网页不能替个人决定。AZOR 已含氨氯地平和奥美沙坦酯，另一个同成分产品可能是重复，也可能是专业人员有意安排；只有准确处方、实际药盒和完整药单才能判断。不要自行加上或停掉任何一盒。", "en": "The site cannot decide for an individual. AZOR already contains amlodipine and olmesartan medoxomil, so another same-ingredient product may be duplicative or intentionally prescribed. Only exact prescriptions, packs and the complete medicine list can establish that. Do not add or stop a pack yourself." } }, { "question": { "zh": "长期腹泻只是胃肠不适，可以先等等吗？", "en": "Is persistent diarrhoea just a stomach problem that can wait?" }, "answer": { "zh": "标签记录奥美沙坦相关类乳糜泻性肠病可能在开始使用数月到数年后出现，并可伴严重慢性腹泻和明显体重下降。应尽快联系医疗团队核对；出现脱水、晕厥、意识异常或无法进水时使用当地急救服务。网页不作个人诊断。", "en": "The label records that olmesartan-associated sprue-like enteropathy may occur months to years after initiation and may involve severe chronic diarrhoea and substantial weight loss. Contact the care team promptly; use local emergency services for dehydration, fainting, altered consciousness or inability to take fluids. The site does not diagnose an individual." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "how-to-read-a-drug-label", "dosage-forms-are-part-of-medicine-identity" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/azor/", "en": "https://origindrug.com/en/drugs/azor/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "tribenzor", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-29", "status": "published_traceable_archive" }, "names": { "brand": "TRIBENZOR", "generic": "奥美沙坦酯/氨氯地平/氢氯噻嗪片", "aliases": [ "Tribenzor", "olmesartan amlodipine hydrochlorothiazide", "olmesartan/amlodipine/hydrochlorothiazide", "olmesartan medoxomil amlodipine hydrochlorothiazide", "奥美沙坦氨氯地平氢氯噻嗪", "奥美沙坦酯氨氯地平氢氯噻嗪片", "olmesartan medoxomil amlodipine and hydrochlorothiazide", "奥美沙坦酯/氨氯地平/氢氯噻嗪", "奥美沙坦氨氯地平氢氯噻嗪片", "NDA 200175", "0713-0874-30", "0713-0875-30", "0713-0876-30", "0713-0877-30", "0713-0878-30", "TRIBENZOR C51", "TRIBENZOR C53", "TRIBENZOR C54", "TRIBENZOR C55", "TRIBENZOR C57" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "心血管", "sourceArchiveMarket": "美国：DailyMed 当前 TRIBENZOR 标签（2023-07-12 更新）列示奥美沙坦酯/氨氯地平/氢氯噻嗪薄膜衣口服片、五个规格及五个准确 30 片瓶装面板；FDA Orange Book 2026-08-28 数据将 NDA 200175 五个规格均列为处方 RLD，40/10/25 mg 同时列为 RS。页面不由此推定实时库存、购买资格、其他市场包装或可替代性。", "dosageFormClass": "奥美沙坦酯/氨氯地平/氢氯噻嗪固定三成分薄膜衣口服片：20/5/12.5、40/5/12.5、40/5/25、40/10/12.5、40/10/25 mg；三数字按药盒成分顺序属于同一片", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "2010", "archiveSponsorText": "Cosette Pharmaceuticals, Inc.（FDA 当前申请与 DailyMed 标签记录）" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [ "AZOR", "BENICAR", "NORVASC", "MICROZIDE", "BENICAR HCT", "EXFORGE", "EXFORGE HCT", "HYZAAR", "DIOVAN HCT", "ZESTORETIC", "AVALIDE" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-tribenzor-olmesartan-20mg-amlodipine-5mg-hydrochlorothiazide-12-5mg-30-bottle-ndc-0713087430", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（2023-07-12 更新；2026-08-29 核验）", "en": "Current U.S. DailyMed public label (updated 12 Jul 2023; verified 29 Aug 2026)" }, "dosageForm": { "zh": "TRIBENZOR 奥美沙坦酯/氨氯地平/氢氯噻嗪薄膜衣口服片", "en": "TRIBENZOR olmesartan medoxomil/amlodipine/hydrochlorothiazide film-coated oral tablet" }, "route": { "zh": "口服（固定三成分产品身份字段）", "en": "oral (fixed three-ingredient product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 0713-0874-30", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片奥美沙坦酯 20 mg＋氨氯地平 5 mg＋氢氯噻嗪 12.5 mg；30 片瓶装", "en": "Olmesartan medoxomil 20 mg plus amlodipine 5 mg plus hydrochlorothiazide 12.5 mg per tablet; 30-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=tribenzor-06.jpg&setid=2f56d0bc-236b-41a0-9fc0-21cdfea8d890", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "奥美沙坦酯", "en": "olmesartan medoxomil" }, "value": 20, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片药盒顺序第一成分；不是个人片数或换算指令", "en": "first ingredient in the pack-order strength per tablet; not an individual tablet count or conversion instruction" } }, { "ingredient": { "zh": "氨氯地平", "en": "amlodipine" }, "value": 5, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片药盒顺序第二成分；不是加用另一种降压药的指令", "en": "second ingredient in the pack-order strength per tablet; not an instruction to add another blood-pressure medicine" } }, { "ingredient": { "zh": "氢氯噻嗪", "en": "hydrochlorothiazide" }, "value": 12.5, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片药盒顺序第三成分；不是个人利尿剂加减量指令", "en": "third ingredient in the pack-order strength per tablet; not an individual diuretic-adjustment instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "塑料瓶", "en": "plastic bottle" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-29", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "current_regulatory_listing_not_inventory", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 30, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "橙白色", "en": "orange white" }, "shape": { "zh": "圆形、无刻痕薄膜衣片，约 8 mm；无刻痕不表示可自行掰开或磨碎", "en": "round, unscored film-coated tablet, approximately 8 mm; an unscored tablet does not establish permission to split or crush it" }, "imprint": "C51", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_993bceff99f61273", "label": "DailyMed（NLM）：TRIBENZOR 20/5/12.5 mg、NDC 0713-0874-30、30 片瓶装美国公开标签面板", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=2f56d0bc-236b-41a0-9fc0-21cdfea8d890", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-tribenzor-olmesartan-40mg-amlodipine-5mg-hydrochlorothiazide-12-5mg-30-bottle-ndc-0713087530", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（2023-07-12 更新；2026-08-29 核验）", "en": "Current U.S. DailyMed public label (updated 12 Jul 2023; verified 29 Aug 2026)" }, "dosageForm": { "zh": "TRIBENZOR 奥美沙坦酯/氨氯地平/氢氯噻嗪薄膜衣口服片", "en": "TRIBENZOR olmesartan medoxomil/amlodipine/hydrochlorothiazide film-coated oral tablet" }, "route": { "zh": "口服（固定三成分产品身份字段）", "en": "oral (fixed three-ingredient product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 0713-0875-30", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片奥美沙坦酯 40 mg＋氨氯地平 5 mg＋氢氯噻嗪 12.5 mg；30 片瓶装", "en": "Olmesartan medoxomil 40 mg plus amlodipine 5 mg plus hydrochlorothiazide 12.5 mg per tablet; 30-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=tribenzor-07.jpg&setid=2f56d0bc-236b-41a0-9fc0-21cdfea8d890", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "奥美沙坦酯", "en": "olmesartan medoxomil" }, "value": 40, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片药盒顺序第一成分；不是个人片数或换算指令", "en": "first ingredient in the pack-order strength per tablet; not an individual tablet count or conversion instruction" } }, { "ingredient": { "zh": "氨氯地平", "en": "amlodipine" }, "value": 5, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片药盒顺序第二成分；不是加用另一种降压药的指令", "en": "second ingredient in the pack-order strength per tablet; not an instruction to add another blood-pressure medicine" } }, { "ingredient": { "zh": "氢氯噻嗪", "en": "hydrochlorothiazide" }, "value": 12.5, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片药盒顺序第三成分；不是个人利尿剂加减量指令", "en": "third ingredient in the pack-order strength per tablet; not an individual diuretic-adjustment instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "塑料瓶", "en": "plastic bottle" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-29", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "current_regulatory_listing_not_inventory", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 30, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "浅黄色", "en": "light yellow" }, "shape": { "zh": "圆形、无刻痕薄膜衣片，约 10 mm；无刻痕不表示可自行掰开或磨碎", "en": "round, unscored film-coated tablet, approximately 10 mm; an unscored tablet does not establish permission to split or crush it" }, "imprint": "C53", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_993bceff99f61273", "label": "DailyMed（NLM）：TRIBENZOR 40/5/12.5 mg、NDC 0713-0875-30、30 片瓶装美国公开标签面板", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=2f56d0bc-236b-41a0-9fc0-21cdfea8d890", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-tribenzor-olmesartan-40mg-amlodipine-5mg-hydrochlorothiazide-25mg-30-bottle-ndc-0713087630", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（2023-07-12 更新；2026-08-29 核验）", "en": "Current U.S. DailyMed public label (updated 12 Jul 2023; verified 29 Aug 2026)" }, "dosageForm": { "zh": "TRIBENZOR 奥美沙坦酯/氨氯地平/氢氯噻嗪薄膜衣口服片", "en": "TRIBENZOR olmesartan medoxomil/amlodipine/hydrochlorothiazide film-coated oral tablet" }, "route": { "zh": "口服（固定三成分产品身份字段）", "en": "oral (fixed three-ingredient product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 0713-0876-30", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片奥美沙坦酯 40 mg＋氨氯地平 5 mg＋氢氯噻嗪 25 mg；30 片瓶装", "en": "Olmesartan medoxomil 40 mg plus amlodipine 5 mg plus hydrochlorothiazide 25 mg per tablet; 30-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=tribenzor-08.jpg&setid=2f56d0bc-236b-41a0-9fc0-21cdfea8d890", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "奥美沙坦酯", "en": "olmesartan medoxomil" }, "value": 40, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片药盒顺序第一成分；不是个人片数或换算指令", "en": "first ingredient in the pack-order strength per tablet; not an individual tablet count or conversion instruction" } }, { "ingredient": { "zh": "氨氯地平", "en": "amlodipine" }, "value": 5, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片药盒顺序第二成分；不是加用另一种降压药的指令", "en": "second ingredient in the pack-order strength per tablet; not an instruction to add another blood-pressure medicine" } }, { "ingredient": { "zh": "氢氯噻嗪", "en": "hydrochlorothiazide" }, "value": 25, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片药盒顺序第三成分；不是个人利尿剂加减量指令", "en": "third ingredient in the pack-order strength per tablet; not an individual diuretic-adjustment instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "塑料瓶", "en": "plastic bottle" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-29", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "current_regulatory_listing_not_inventory", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 30, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "浅黄色", "en": "light yellow" }, "shape": { "zh": "椭圆形、无刻痕薄膜衣片，约 15 mm；无刻痕不表示可自行掰开或磨碎", "en": "oval, unscored film-coated tablet, approximately 15 mm; an unscored tablet does not establish permission to split or crush it" }, "imprint": "C54", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_993bceff99f61273", "label": "DailyMed（NLM）：TRIBENZOR 40/5/25 mg、NDC 0713-0876-30、30 片瓶装美国公开标签面板", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=2f56d0bc-236b-41a0-9fc0-21cdfea8d890", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-tribenzor-olmesartan-40mg-amlodipine-10mg-hydrochlorothiazide-12-5mg-30-bottle-ndc-0713087730", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（2023-07-12 更新；2026-08-29 核验）", "en": "Current U.S. DailyMed public label (updated 12 Jul 2023; verified 29 Aug 2026)" }, "dosageForm": { "zh": "TRIBENZOR 奥美沙坦酯/氨氯地平/氢氯噻嗪薄膜衣口服片", "en": "TRIBENZOR olmesartan medoxomil/amlodipine/hydrochlorothiazide film-coated oral tablet" }, "route": { "zh": "口服（固定三成分产品身份字段）", "en": "oral (fixed three-ingredient product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 0713-0877-30", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片奥美沙坦酯 40 mg＋氨氯地平 10 mg＋氢氯噻嗪 12.5 mg；30 片瓶装", "en": "Olmesartan medoxomil 40 mg plus amlodipine 10 mg plus hydrochlorothiazide 12.5 mg per tablet; 30-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=tribenzor-09.jpg&setid=2f56d0bc-236b-41a0-9fc0-21cdfea8d890", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "奥美沙坦酯", "en": "olmesartan medoxomil" }, "value": 40, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片药盒顺序第一成分；不是个人片数或换算指令", "en": "first ingredient in the pack-order strength per tablet; not an individual tablet count or conversion instruction" } }, { "ingredient": { "zh": "氨氯地平", "en": "amlodipine" }, "value": 10, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片药盒顺序第二成分；不是加用另一种降压药的指令", "en": "second ingredient in the pack-order strength per tablet; not an instruction to add another blood-pressure medicine" } }, { "ingredient": { "zh": "氢氯噻嗪", "en": "hydrochlorothiazide" }, "value": 12.5, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片药盒顺序第三成分；不是个人利尿剂加减量指令", "en": "third ingredient in the pack-order strength per tablet; not an individual diuretic-adjustment instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "塑料瓶", "en": "plastic bottle" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-29", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "current_regulatory_listing_not_inventory", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 30, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "灰红色", "en": "grayish red" }, "shape": { "zh": "圆形、无刻痕薄膜衣片，约 10 mm；无刻痕不表示可自行掰开或磨碎", "en": "round, unscored film-coated tablet, approximately 10 mm; an unscored tablet does not establish permission to split or crush it" }, "imprint": "C55", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_993bceff99f61273", "label": "DailyMed（NLM）：TRIBENZOR 40/10/12.5 mg、NDC 0713-0877-30、30 片瓶装美国公开标签面板", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=2f56d0bc-236b-41a0-9fc0-21cdfea8d890", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-tribenzor-olmesartan-40mg-amlodipine-10mg-hydrochlorothiazide-25mg-30-bottle-ndc-0713087830", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（2023-07-12 更新；2026-08-29 核验）", "en": "Current U.S. DailyMed public label (updated 12 Jul 2023; verified 29 Aug 2026)" }, "dosageForm": { "zh": "TRIBENZOR 奥美沙坦酯/氨氯地平/氢氯噻嗪薄膜衣口服片", "en": "TRIBENZOR olmesartan medoxomil/amlodipine/hydrochlorothiazide film-coated oral tablet" }, "route": { "zh": "口服（固定三成分产品身份字段）", "en": "oral (fixed three-ingredient product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 0713-0878-30", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片奥美沙坦酯 40 mg＋氨氯地平 10 mg＋氢氯噻嗪 25 mg；30 片瓶装", "en": "Olmesartan medoxomil 40 mg plus amlodipine 10 mg plus hydrochlorothiazide 25 mg per tablet; 30-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=tribenzor-0a.jpg&setid=2f56d0bc-236b-41a0-9fc0-21cdfea8d890", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "奥美沙坦酯", "en": "olmesartan medoxomil" }, "value": 40, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片药盒顺序第一成分；不是个人片数或换算指令", "en": "first ingredient in the pack-order strength per tablet; not an individual tablet count or conversion instruction" } }, { "ingredient": { "zh": "氨氯地平", "en": "amlodipine" }, "value": 10, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片药盒顺序第二成分；不是加用另一种降压药的指令", "en": "second ingredient in the pack-order strength per tablet; not an instruction to add another blood-pressure medicine" } }, { "ingredient": { "zh": "氢氯噻嗪", "en": "hydrochlorothiazide" }, "value": 25, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片药盒顺序第三成分；不是个人利尿剂加减量指令", "en": "third ingredient in the pack-order strength per tablet; not an individual diuretic-adjustment instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "塑料瓶", "en": "plastic bottle" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-29", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "current_regulatory_listing_not_inventory", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 30, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "灰红色", "en": "grayish red" }, "shape": { "zh": "椭圆形、无刻痕薄膜衣片，约 15 mm；无刻痕不表示可自行掰开或磨碎", "en": "oval, unscored film-coated tablet, approximately 15 mm; an unscored tablet does not establish permission to split or crush it" }, "imprint": "C57", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_993bceff99f61273", "label": "DailyMed（NLM）：TRIBENZOR 40/10/25 mg、NDC 0713-0878-30、30 片瓶装美国公开标签面板", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=2f56d0bc-236b-41a0-9fc0-21cdfea8d890", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-tribenzor-olmesartan-20mg-amlodipine-5mg-hydrochlorothiazide-12-5mg-30-bottle-ndc-0713087430", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=tribenzor-06.jpg&setid=2f56d0bc-236b-41a0-9fc0-21cdfea8d890", "alt": { "zh": "DailyMed 当前 TRIBENZOR 20/5/12.5 mg、NDC 0713-0874-30、30 片瓶装标签面板", "en": "Current DailyMed TRIBENZOR 20/5/12.5 mg, NDC 0713-0874-30, 30-tablet bottle label panel" }, "archiveMarket": "美国", "labelVersion": "DailyMed 美国当前公开标签（2023-07-12 更新）", "presentation": "TRIBENZOR 每片奥美沙坦酯 20 mg/氨氯地平 5 mg/氢氯噻嗪 12.5 mg，NDC 0713-0874-30，30 片瓶装。", "notice": "此图只对应当前标签中的 TRIBENZOR 20/5/12.5 mg、NDC 0713-0874-30、30 片瓶装面板；不能代表另四个规格、其他市场或仿制药，不用于鉴定真伪，也不证明实时库存、个人片数或可替代性。", "source": { "id": "src_993bceff99f61273", "label": "DailyMed（NLM）：TRIBENZOR 20/5/12.5 mg、NDC 0713-0874-30、30 片瓶装美国公开标签面板", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=2f56d0bc-236b-41a0-9fc0-21cdfea8d890", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "TRIBENZOR 说明书放大阅读：一片已有三种降压成分，先核对奥美沙坦、氨氯地平和氢氯噻嗪是否重复", "en": "TRIBENZOR label reading: one tablet already contains three blood-pressure ingredients; first check duplicate olmesartan, amlodipine and hydrochlorothiazide" }, "summary": { "zh": "TRIBENZOR 每片固定含奥美沙坦酯、氨氯地平和氢氯噻嗪。例如 40/10/25 mg 表示同一片内三种成分各自的标签量；不能理解成三片、分片或可与单方/双联产品直接相加换算。当前标签还明确本固定复方不用于高血压初始治疗，这不是网页替个人决定开始、停用或换药。", "en": "Each TRIBENZOR tablet contains fixed amounts of olmesartan medoxomil, amlodipine and hydrochlorothiazide. For example, 40/10/25 mg states the labelled amount of each ingredient in one tablet; it is not three tablets, a splitting cue or a sum that can be directly converted with single- or dual-ingredient products. The current label also states that this fixed combination is not indicated for initial hypertension therapy; that is not a website decision to start, stop or switch an individual's medicine." }, "checks": [ { "zh": "逐盒看有效成分。AZOR 已含奥美沙坦和氨氯地平，BENICAR、NORVASC、MICROZIDE 分别是可能重复的单方成分；BENICAR HCT、EXFORGE HCT、HYZAAR、DIOVAN HCT、ZESTORETIC、AVALIDE 也可能共享一种或多种成分。若同时出现在药单，不要自行删掉或加上任何一盒，应由药师或开方团队结合完整处方判断。", "en": "Read the active ingredients on every pack. AZOR already contains olmesartan and amlodipine; BENICAR, NORVASC and MICROZIDE are single-ingredient products that may duplicate one component. BENICAR HCT, EXFORGE HCT, HYZAAR, DIOVAN HCT, ZESTORETIC and AVALIDE may also share one or more ingredients. If they appear together, do not add or remove a pack yourself; a pharmacist or prescriber must review the complete prescriptions." }, { "zh": "标签有胎儿毒性黑框警示。已经怀孕、可能怀孕或计划怀孕者应立即联系开方团队核对；不要等待网页判断，也不要自行安排停换药。", "en": "The label carries a boxed warning for fetal toxicity. Anyone who is pregnant, may be pregnant or plans pregnancy should contact the prescribing team promptly; do not wait for a website decision or arrange stopping or switching independently." }, { "zh": "老人或体弱者若明显头晕、晕厥、跌倒、尿量减少，或持续呕吐腹泻并有脱水迹象，应及时联系医疗团队；严重或突然时使用当地急救服务。三成分共同涉及血压、肾功能、电解质和体液状态，网页不按年龄或单次数字生成方案。", "en": "Older or frail adults with marked dizziness, fainting, a fall, reduced urine, or persistent vomiting or diarrhoea with dehydration signs should contact the care team promptly; use local emergency services for severe or sudden symptoms. The three ingredients jointly make blood pressure, kidney function, electrolytes and fluid status relevant; the site does not generate a regimen from age or one reading." }, { "zh": "严重、持续的慢性腹泻并伴明显体重下降，可能与标签所述类乳糜泻性肠病有关，即使已使用数月或数年也应尽快联系医疗团队；出现脱水、晕厥、意识异常或无法进水时使用当地急救服务。", "en": "Severe, persistent chronic diarrhoea with substantial weight loss may relate to the labelled sprue-like enteropathy, even after months or years of use, and warrants prompt contact with the care team. Use local emergency services for dehydration, fainting, altered consciousness or inability to take fluids." }, { "zh": "突然眼痛或视力下降属于氢氯噻嗪标签中的急性近视/继发性闭角型青光眼警示，应立即寻求医疗帮助；网页不等待照片识别，也不提供自行停换药方案。", "en": "Sudden eye pain or reduced vision falls within the hydrochlorothiazide label warning for acute myopia/secondary angle-closure glaucoma and needs immediate medical attention. Do not wait for photo identification or use the site for a self-directed stopping or switching plan." }, { "zh": "标签提示氢氯噻嗪与非黑色素瘤皮肤癌风险增加有关，并建议防晒和定期皮肤检查。这不表示网页可以从皮肤照片诊断；发现新生、变化或不愈合皮损时应联系专业人员。", "en": "The label associates hydrochlorothiazide with increased non-melanoma skin-cancer risk and advises sun protection and regular skin screening. This does not let the site diagnose a skin photograph; contact a professional for a new, changing or non-healing lesion." }, { "zh": "糖尿病患者合用阿利吉仑属于标签禁忌边界。其他 RAS 药物、NSAID、锂盐、含钾补充剂或代盐、考来维仑，以及氨氯地平与辛伐他汀（标签写明 20 mg/日上限）均须按准确产品和完整药单核对；网页不改变个人剂量或安排间隔。", "en": "The label contraindicates aliskiren coadministration in patients with diabetes. Other RAS medicines, NSAIDs, lithium, potassium supplements or salt substitutes, colesevelam, and amlodipine with simvastatin (the label states a 20 mg/day limit) require exact-product and full-list review. The site does not change an individual's dose or arrange an interval." }, { "zh": "五种片剂均为薄膜衣、无刻痕；圆形与椭圆形、颜色、印字和 NDC 只用于包装身份核对。无刻痕不等于可自行掰开、磨碎或按颜色换药。", "en": "All five tablets are film-coated and unscored; round or oval shape, colour, imprint and NDC are product-identity clues only. An unscored tablet does not permit self-splitting, crushing or colour-based switching." } ], "source": { "id": "src_993bceff99f61273", "label": "DailyMed（NLM）：TRIBENZOR 奥美沙坦酯/氨氯地平/氢氯噻嗪当前美国公开标签（2023-07-12 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=2f56d0bc-236b-41a0-9fc0-21cdfea8d890", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "三种成分怎样协同：ARB、钙通道阻滞剂与噻嗪类利尿剂三条路径", "en": "How three ingredients work together: ARB, calcium-channel blocker and thiazide-diuretic pathways" }, "summary": { "zh": "当前标签说明：奥美沙坦阻断血管紧张素 II 的 AT1 受体作用；氨氯地平帮助外周动脉舒张；氢氯噻嗪影响肾小管对电解质的重吸收并增加钠、氯排泄。三条路径放在同一片中，不表示网页能按血压、尿量或化验数字拆分或重组个人方案。", "en": "The current label explains that olmesartan blocks angiotensin II activity at the AT1 receptor, amlodipine supports peripheral arterial vasodilation, and hydrochlorothiazide affects renal-tubular electrolyte reabsorption and increases sodium and chloride excretion. Combining three pathways in one tablet does not let the site split or rebuild an individual's regimen from blood pressure, urine output or a laboratory result." }, "checks": [ { "zh": "共同的降压目的不表示单方、双联与三联产品可自行叠加或换算。三种成分分别使完整药单、血压、肾功能、电解质、体液状态与相互作用核对更重要。", "en": "A shared blood-pressure purpose does not make single-, dual- and triple-ingredient products self-combinable or convertible. The three ingredients make review of the complete medicine list, blood pressure, kidney function, electrolytes, fluid status and interactions especially important." }, { "zh": "药盒三数字按奥美沙坦酯/氨氯地平/氢氯噻嗪排列；Orange Book 数据的成分和强度按其数据字段顺序呈现。必须连同成分名称读取，不能把第一个数字机械对到另一个列表的第一个成分。", "en": "The pack orders its three numbers as olmesartan medoxomil/amlodipine/hydrochlorothiazide, while Orange Book ingredient and strength fields follow that dataset's order. Read the ingredient names with the numbers; do not mechanically map the first number to the first ingredient in another list." }, { "zh": "机制页面不能处理突发胸痛、晕厥、严重呼吸困难、眼痛/视力下降、严重脱水、过敏或其他急性严重不适。出现这些担忧时使用当地医疗支持，不从机制文字自行调整。", "en": "A mechanism page cannot manage sudden chest pain, fainting, severe breathing difficulty, eye pain/reduced vision, severe dehydration, allergy or another acute severe problem. Use local medical support rather than self-adjusting from mechanism text." } ], "source": { "id": "src_993bceff99f61273", "label": "DailyMed（NLM）：TRIBENZOR 奥美沙坦酯/氨氯地平/氢氯噻嗪当前美国公开标签（2023-07-12 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=2f56d0bc-236b-41a0-9fc0-21cdfea8d890", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "TRIBENZOR", "generic": "奥美沙坦酯/氨氯地平/氢氯噻嗪片", "dosageFormClass": "奥美沙坦酯/氨氯地平/氢氯噻嗪固定三成分薄膜衣口服片：20/5/12.5、40/5/12.5、40/5/25、40/10/12.5、40/10/25 mg；三数字按药盒成分顺序属于同一片" }, "labelSource": { "id": "src_993bceff99f61273", "label": "DailyMed（NLM）：TRIBENZOR 奥美沙坦酯/氨氯地平/氢氯噻嗪当前美国公开标签（2023-07-12 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=2f56d0bc-236b-41a0-9fc0-21cdfea8d890", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "productRoutes": [ { "source": { "id": "src_993bceff99f61273", "label": "DailyMed（NLM）：TRIBENZOR 奥美沙坦酯/氨氯地平/氢氯噻嗪当前美国公开标签（2023-07-12 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=2f56d0bc-236b-41a0-9fc0-21cdfea8d890", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-29", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_10e511bf83430e3b", "label": "FDA Orange Book 当前数据：TRIBENZOR，NDA 200175，五个口服片规格均列为处方 RLD；40/10/25 mg 同时列为 RS", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-08-29", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_9ddcb06f7196a1e3", "label": "FDA Drugs@FDA 官方检索入口：TRIBENZOR NDA 200175 原始批准与申请记录", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-08-29", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-29", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "TRIBENZOR 一片同时含奥美沙坦酯、氨氯地平和氢氯噻嗪。药盒上的三组数字表示同一片内三种成分各有多少毫克，不是三片、分片或加减公式。若药单还有 AZOR、BENICAR、NORVASC、MICROZIDE，或 BENICAR HCT、EXFORGE HCT、HYZAAR、DIOVAN HCT、ZESTORETIC、AVALIDE 等可能共享成分的产品，应带所有药盒和处方让药师或开方团队逐项核对，不要自行叠加、停药、轮换或按毫克换算。", "history": "FDA 原始批准函与 Orange Book 记录 TRIBENZOR NDA 200175 于 2010-07-23 获批，五个规格均为处方 RLD；当前数据将 40/10/25 mg 同时列为 RS。DailyMed 当前标签页面于 2023-07-12 更新，五个 NDC 的 30 片瓶装营销起始日期列为 2022-09-01，未列营销结束日期；这仍不是实时库存证明。", "sourceDocuments": [ { "id": "src_993bceff99f61273", "label": "DailyMed（NLM）：TRIBENZOR 奥美沙坦酯/氨氯地平/氢氯噻嗪当前美国公开标签（2023-07-12 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=2f56d0bc-236b-41a0-9fc0-21cdfea8d890", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, { "id": "src_10e511bf83430e3b", "label": "FDA Orange Book 当前数据：TRIBENZOR，NDA 200175，五个口服片规格均列为处方 RLD；40/10/25 mg 同时列为 RS", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, { "id": "src_9ddcb06f7196a1e3", "label": "FDA Drugs@FDA 官方检索入口：TRIBENZOR NDA 200175 原始批准与申请记录", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, { "id": "src_3774a6b7c7a72aab", "label": "FDA：TRIBENZOR NDA 200175 原始批准函（2010-07-23）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/200175s000ltr.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_regulatory_record", "documentKind": "regulatory_review", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_pdf", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, { "id": "src_4b54955586218a69", "label": "FDA：TRIBENZOR NDA 200175 原始审评资料（505(b)(2)，2010）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/200175Orig1s000OtherR.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_regulatory_record", "documentKind": "regulatory_review", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_pdf", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } ], "applicationNumber": "FDA NDA 200175（TRIBENZOR / olmesartan medoxomil, amlodipine and hydrochlorothiazide oral tablets）", "approvalTimeline": [ { "date": "2010-07-23", "title": { "zh": "TRIBENZOR 原始批准", "en": "Original TRIBENZOR approval" }, "detail": { "zh": "FDA 批准函和当前 Orange Book 数据记录 NDA 200175 的五个固定三成分规格。", "en": "The FDA approval letter and current Orange Book data record five fixed three-ingredient strengths under NDA 200175." }, "source": { "id": "src_3774a6b7c7a72aab", "label": "FDA：TRIBENZOR NDA 200175 原始批准函（2010-07-23）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/200175s000ltr.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_regulatory_record", "documentKind": "regulatory_review", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_pdf", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } }, { "date": "2022-09-01", "title": { "zh": "当前五个 NDC 标签营销起始日期", "en": "Current label marketing-start date for five NDCs" }, "detail": { "zh": "DailyMed 当前页面对五个 30 片瓶装 NDC 均列 2022-09-01 为营销起始日期且未列结束日期；这不是实时库存证明。", "en": "The current DailyMed page lists 1 Sep 2022 as the marketing-start date for all five 30-tablet bottle NDCs and no end date; this is not real-time stock evidence." }, "source": { "id": "src_993bceff99f61273", "label": "DailyMed（NLM）：TRIBENZOR 奥美沙坦酯/氨氯地平/氢氯噻嗪当前美国公开标签（2023-07-12 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=2f56d0bc-236b-41a0-9fc0-21cdfea8d890", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } }, { "date": "2023-07-12", "title": { "zh": "当前公开标签页面更新", "en": "Current public label page updated" }, "detail": { "zh": "DailyMed 当前页面列示五个规格、五个准确 30 片瓶装面板、外观和放大安全信息。", "en": "The current DailyMed page lists five strengths, five exact 30-tablet bottle panels, appearance and enlarged safety information." }, "source": { "id": "src_993bceff99f61273", "label": "DailyMed（NLM）：TRIBENZOR 奥美沙坦酯/氨氯地平/氢氯噻嗪当前美国公开标签（2023-07-12 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=2f56d0bc-236b-41a0-9fc0-21cdfea8d890", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } }, { "date": "2026-08-28", "title": { "zh": "当前 Orange Book 身份核验", "en": "Current Orange Book identity reviewed" }, "detail": { "zh": "当前数据将五个规格均列为处方 RLD，并将 40/10/25 mg 列为 RS。", "en": "Current data list all five strengths as prescription RLD products and 40/10/25 mg as the RS." }, "source": { "id": "src_10e511bf83430e3b", "label": "FDA Orange Book 当前数据：TRIBENZOR，NDA 200175，五个口服片规格均列为处方 RLD；40/10/25 mg 同时列为 RS", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "五个处方 RLD 规格；40/10/25 mg 同时为 RS；五个当前标签 NDC 无营销结束日期", "en": "Five prescription RLD strengths; 40/10/25 mg also RS; five current-label NDCs have no marketing end date" }, "detail": { "zh": "这些官方记录支持核对产品身份，不证明药房实时库存、购买资格或可替代性。", "en": "These official records support product-identity review; they do not establish real-time pharmacy stock, purchasing eligibility or interchangeability." } }, { "market": { "zh": "中国大陆及其他市场", "en": "Mainland China and other markets" }, "status": { "zh": "待逐项建立现行市场记录", "en": "Current market record not established" }, "detail": { "zh": "不从美国品牌、共同成分或 mg 数字推定当地批准、商品名、包装、供应或可替代性。", "en": "No local approval, trade name, pack, supply or interchangeability is inferred from the U.S. brand, shared ingredients or milligram numbers." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "40/10/25 mg 是不是三片药？", "en": "Does 40/10/25 mg mean three tablets?" }, "answer": { "zh": "不是。它表示同一片内有奥美沙坦酯 40 mg、氨氯地平 10 mg 和氢氯噻嗪 25 mg。网页不会把三数字转换为分片、磨碎或个人片数。", "en": "No. It means one tablet contains olmesartan medoxomil 40 mg, amlodipine 10 mg and hydrochlorothiazide 25 mg. The site does not convert the three numbers into splitting, crushing or an individual tablet count." } }, { "question": { "zh": "已经吃 TRIBENZOR，还能再吃 AZOR、NORVASC 或利尿药吗？", "en": "Can AZOR, NORVASC or a diuretic be taken in addition to TRIBENZOR?" }, "answer": { "zh": "网页不能替个人决定。TRIBENZOR 已含奥美沙坦、氨氯地平和氢氯噻嗪，另一个共享成分产品可能重复，也可能是专业人员有意安排；只有准确处方、实际药盒和完整药单才能判断。不要自行加上或停掉任何一盒。", "en": "The site cannot decide for an individual. TRIBENZOR already contains olmesartan, amlodipine and hydrochlorothiazide, so another shared-ingredient product may be duplicative or intentionally prescribed. Only exact prescriptions, packs and the complete medicine list can establish that. Do not add or stop a pack yourself." } }, { "question": { "zh": "Orange Book 为什么把数字顺序写得不一样？", "en": "Why can Orange Book show the numbers in a different order?" }, "answer": { "zh": "药盒按奥美沙坦酯/氨氯地平/氢氯噻嗪排列；Orange Book 当前数据把成分列为氨氯地平/氢氯噻嗪/奥美沙坦酯，并按同一顺序列强度。两边都必须连同成分名称读取，不能只看数字位置。", "en": "The pack orders olmesartan medoxomil/amlodipine/hydrochlorothiazide, while current Orange Book data list amlodipine/hydrochlorothiazide/olmesartan medoxomil and order strengths accordingly. Read ingredient names with both lists rather than comparing number positions alone." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "how-to-read-a-drug-label", "dosage-forms-are-part-of-medicine-identity" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/tribenzor/", "en": "https://origindrug.com/en/drugs/tribenzor/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "caduet", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-29", "status": "published_traceable_archive" }, "names": { "brand": "CADUET", "generic": "氨氯地平/阿托伐他汀片", "aliases": [ "Caduet", "amlodipine atorvastatin", "amlodipine and atorvastatin", "amlodipine/atorvastatin", "氨氯地平阿托伐他汀", "氨氯地平阿托伐他汀片", "氨氯地平/阿托伐他汀", "NDA 021540", "58151-064-93", "58151-065-93", "58151-066-93", "58151-067-93", "58151-060-93", "58151-061-93", "58151-062-93", "58151-063-93", "CADUET CDT 051", "CADUET CDT 052", "CADUET CDT 054", "CADUET CDT 058", "CADUET CDT 101", "CADUET CDT 102", "CADUET CDT 104", "CADUET CDT 108" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "心血管", "sourceArchiveMarket": "美国：DailyMed 当前 CADUET 标签（2026-06-25 更新）列示氨氯地平 5 或 10 mg 与阿托伐他汀 10、20、40 或 80 mg 组成的八个规格、八个准确 30 片瓶装面板和各自 NDC；其中 10/10 与 10/20 mg 的当前标签记录同时列出 2026-03-03 营销起止日期。FDA Orange Book 2026-08-28 数据在 NDA 021540 下另列三个 2.5 mg 氨氯地平组合，共 11 个处方 RLD 规格，10/80 mg 同时为 RS。页面不把 Orange Book 规格、标签日期或 NDC 记录解释成实时库存、购买资格或可替代性。", "dosageFormClass": "氨氯地平/阿托伐他汀固定两成分薄膜衣口服片：当前标签八个 5 或 10 mg／10、20、40 或 80 mg 组合；每组两个数字属于同一片内两种成分", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "2004", "archiveSponsorText": "Viatris Specialty LLC（DailyMed 当前标签）；Pharmacia and Upjohn Co LLC（FDA Orange Book 当前申请记录）" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [ "NORVASC", "amlodipine tablet", "LIPITOR", "atorvastatin tablet", "LOTREL", "AZOR", "EXFORGE", "EXFORGE HCT", "TRIBENZOR" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-caduet-amlodipine-5mg-atorvastatin-10mg-30-bottle-ndc-5815106493", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（2026-06-25 更新；2026-08-29 核验）", "en": "Current U.S. DailyMed public label (updated 25 Jun 2026; verified 29 Aug 2026)" }, "dosageForm": { "zh": "CADUET 氨氯地平/阿托伐他汀薄膜衣口服片", "en": "CADUET amlodipine/atorvastatin film-coated oral tablet" }, "route": { "zh": "口服（固定两成分产品身份字段）", "en": "oral (fixed two-ingredient product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 58151-064-93", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片氨氯地平 5 mg＋阿托伐他汀 10 mg；30 片瓶装", "en": "Amlodipine 5 mg plus atorvastatin 10 mg per tablet; 30-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=caduet-10.jpg&setid=164394b3-d7ba-4bbf-b64b-e2dd15735ea8", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "氨氯地平", "en": "amlodipine" }, "value": 5, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片第一成分标签量；不是个人片数、加量或换算指令", "en": "labelled amount of the first ingredient per tablet; not an individual tablet count, increase or conversion instruction" } }, { "ingredient": { "zh": "阿托伐他汀", "en": "atorvastatin" }, "value": 10, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片第二成分标签量；不是另加一盒他汀或换算指令", "en": "labelled amount of the second ingredient per tablet; not an instruction to add another statin or convert products" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "塑料瓶", "en": "plastic bottle" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-29", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "current_regulatory_listing_not_inventory", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 30, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "白色", "en": "white" }, "shape": { "zh": "椭圆形、无刻痕薄膜衣片，约 9 mm；无刻痕不表示可自行掰开或磨碎", "en": "oval, unscored film-coated tablet, approximately 9 mm; an unscored tablet does not establish permission to split or crush it" }, "imprint": "CDT;051", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_22af65532a65996f", "label": "DailyMed（NLM）：CADUET 5/10 mg、NDC 58151-064-93、30 片瓶装美国公开标签面板", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=164394b3-d7ba-4bbf-b64b-e2dd15735ea8", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-caduet-amlodipine-5mg-atorvastatin-20mg-30-bottle-ndc-5815106593", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（2026-06-25 更新；2026-08-29 核验）", "en": "Current U.S. DailyMed public label (updated 25 Jun 2026; verified 29 Aug 2026)" }, "dosageForm": { "zh": "CADUET 氨氯地平/阿托伐他汀薄膜衣口服片", "en": "CADUET amlodipine/atorvastatin film-coated oral tablet" }, "route": { "zh": "口服（固定两成分产品身份字段）", "en": "oral (fixed two-ingredient product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 58151-065-93", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片氨氯地平 5 mg＋阿托伐他汀 20 mg；30 片瓶装", "en": "Amlodipine 5 mg plus atorvastatin 20 mg per tablet; 30-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=caduet-11.jpg&setid=164394b3-d7ba-4bbf-b64b-e2dd15735ea8", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "氨氯地平", "en": "amlodipine" }, "value": 5, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片第一成分标签量；不是个人片数、加量或换算指令", "en": "labelled amount of the first ingredient per tablet; not an individual tablet count, increase or conversion instruction" } }, { "ingredient": { "zh": "阿托伐他汀", "en": "atorvastatin" }, "value": 20, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片第二成分标签量；不是另加一盒他汀或换算指令", "en": "labelled amount of the second ingredient per tablet; not an instruction to add another statin or convert products" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "塑料瓶", "en": "plastic bottle" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-29", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "current_regulatory_listing_not_inventory", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 30, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "白色", "en": "white" }, "shape": { "zh": "椭圆形、无刻痕薄膜衣片，约 11 mm；无刻痕不表示可自行掰开或磨碎", "en": "oval, unscored film-coated tablet, approximately 11 mm; an unscored tablet does not establish permission to split or crush it" }, "imprint": "CDT;052", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_22af65532a65996f", "label": "DailyMed（NLM）：CADUET 5/20 mg、NDC 58151-065-93、30 片瓶装美国公开标签面板", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=164394b3-d7ba-4bbf-b64b-e2dd15735ea8", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-caduet-amlodipine-5mg-atorvastatin-40mg-30-bottle-ndc-5815106693", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（2026-06-25 更新；2026-08-29 核验）", "en": "Current U.S. DailyMed public label (updated 25 Jun 2026; verified 29 Aug 2026)" }, "dosageForm": { "zh": "CADUET 氨氯地平/阿托伐他汀薄膜衣口服片", "en": "CADUET amlodipine/atorvastatin film-coated oral tablet" }, "route": { "zh": "口服（固定两成分产品身份字段）", "en": "oral (fixed two-ingredient product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 58151-066-93", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片氨氯地平 5 mg＋阿托伐他汀 40 mg；30 片瓶装", "en": "Amlodipine 5 mg plus atorvastatin 40 mg per tablet; 30-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=caduet-12.jpg&setid=164394b3-d7ba-4bbf-b64b-e2dd15735ea8", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "氨氯地平", "en": "amlodipine" }, "value": 5, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片第一成分标签量；不是个人片数、加量或换算指令", "en": "labelled amount of the first ingredient per tablet; not an individual tablet count, increase or conversion instruction" } }, { "ingredient": { "zh": "阿托伐他汀", "en": "atorvastatin" }, "value": 40, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片第二成分标签量；不是另加一盒他汀或换算指令", "en": "labelled amount of the second ingredient per tablet; not an instruction to add another statin or convert products" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "塑料瓶", "en": "plastic bottle" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-29", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "current_regulatory_listing_not_inventory", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 30, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "白色", "en": "white" }, "shape": { "zh": "椭圆形、无刻痕薄膜衣片，约 14 mm；无刻痕不表示可自行掰开或磨碎", "en": "oval, unscored film-coated tablet, approximately 14 mm; an unscored tablet does not establish permission to split or crush it" }, "imprint": "CDT;054", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_22af65532a65996f", "label": "DailyMed（NLM）：CADUET 5/40 mg、NDC 58151-066-93、30 片瓶装美国公开标签面板", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=164394b3-d7ba-4bbf-b64b-e2dd15735ea8", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-caduet-amlodipine-5mg-atorvastatin-80mg-30-bottle-ndc-5815106793", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（2026-06-25 更新；2026-08-29 核验）", "en": "Current U.S. DailyMed public label (updated 25 Jun 2026; verified 29 Aug 2026)" }, "dosageForm": { "zh": "CADUET 氨氯地平/阿托伐他汀薄膜衣口服片", "en": "CADUET amlodipine/atorvastatin film-coated oral tablet" }, "route": { "zh": "口服（固定两成分产品身份字段）", "en": "oral (fixed two-ingredient product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 58151-067-93", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片氨氯地平 5 mg＋阿托伐他汀 80 mg；30 片瓶装", "en": "Amlodipine 5 mg plus atorvastatin 80 mg per tablet; 30-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=caduet-13.jpg&setid=164394b3-d7ba-4bbf-b64b-e2dd15735ea8", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "氨氯地平", "en": "amlodipine" }, "value": 5, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片第一成分标签量；不是个人片数、加量或换算指令", "en": "labelled amount of the first ingredient per tablet; not an individual tablet count, increase or conversion instruction" } }, { "ingredient": { "zh": "阿托伐他汀", "en": "atorvastatin" }, "value": 80, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片第二成分标签量；不是另加一盒他汀或换算指令", "en": "labelled amount of the second ingredient per tablet; not an instruction to add another statin or convert products" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "塑料瓶", "en": "plastic bottle" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-29", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "current_regulatory_listing_not_inventory", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 30, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "白色", "en": "white" }, "shape": { "zh": "椭圆形、无刻痕薄膜衣片，约 17 mm；无刻痕不表示可自行掰开或磨碎", "en": "oval, unscored film-coated tablet, approximately 17 mm; an unscored tablet does not establish permission to split or crush it" }, "imprint": "CDT;058", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_22af65532a65996f", "label": "DailyMed（NLM）：CADUET 5/80 mg、NDC 58151-067-93、30 片瓶装美国公开标签面板", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=164394b3-d7ba-4bbf-b64b-e2dd15735ea8", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-caduet-amlodipine-10mg-atorvastatin-10mg-30-bottle-ndc-5815106093", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（2026-06-25 更新；2026-08-29 核验）", "en": "Current U.S. DailyMed public label (updated 25 Jun 2026; verified 29 Aug 2026)" }, "dosageForm": { "zh": "CADUET 氨氯地平/阿托伐他汀薄膜衣口服片", "en": "CADUET amlodipine/atorvastatin film-coated oral tablet" }, "route": { "zh": "口服（固定两成分产品身份字段）", "en": "oral (fixed two-ingredient product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 58151-060-93", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片氨氯地平 10 mg＋阿托伐他汀 10 mg；30 片瓶装", "en": "Amlodipine 10 mg plus atorvastatin 10 mg per tablet; 30-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=caduet-14.jpg&setid=164394b3-d7ba-4bbf-b64b-e2dd15735ea8", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "氨氯地平", "en": "amlodipine" }, "value": 10, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片第一成分标签量；不是个人片数、加量或换算指令", "en": "labelled amount of the first ingredient per tablet; not an individual tablet count, increase or conversion instruction" } }, { "ingredient": { "zh": "阿托伐他汀", "en": "atorvastatin" }, "value": 10, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片第二成分标签量；不是另加一盒他汀或换算指令", "en": "labelled amount of the second ingredient per tablet; not an instruction to add another statin or convert products" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "塑料瓶", "en": "plastic bottle" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-29", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "current_label_lists_marketing_end_date", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 30, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "蓝色", "en": "blue" }, "shape": { "zh": "椭圆形、无刻痕薄膜衣片，约 9 mm；无刻痕不表示可自行掰开或磨碎", "en": "oval, unscored film-coated tablet, approximately 9 mm; an unscored tablet does not establish permission to split or crush it" }, "imprint": "CDT;101", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_22af65532a65996f", "label": "DailyMed（NLM）：CADUET 10/10 mg、NDC 58151-060-93、30 片瓶装美国公开标签面板", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=164394b3-d7ba-4bbf-b64b-e2dd15735ea8", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-caduet-amlodipine-10mg-atorvastatin-20mg-30-bottle-ndc-5815106193", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（2026-06-25 更新；2026-08-29 核验）", "en": "Current U.S. DailyMed public label (updated 25 Jun 2026; verified 29 Aug 2026)" }, "dosageForm": { "zh": "CADUET 氨氯地平/阿托伐他汀薄膜衣口服片", "en": "CADUET amlodipine/atorvastatin film-coated oral tablet" }, "route": { "zh": "口服（固定两成分产品身份字段）", "en": "oral (fixed two-ingredient product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 58151-061-93", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片氨氯地平 10 mg＋阿托伐他汀 20 mg；30 片瓶装", "en": "Amlodipine 10 mg plus atorvastatin 20 mg per tablet; 30-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=caduet-15.jpg&setid=164394b3-d7ba-4bbf-b64b-e2dd15735ea8", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "氨氯地平", "en": "amlodipine" }, "value": 10, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片第一成分标签量；不是个人片数、加量或换算指令", "en": "labelled amount of the first ingredient per tablet; not an individual tablet count, increase or conversion instruction" } }, { "ingredient": { "zh": "阿托伐他汀", "en": "atorvastatin" }, "value": 20, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片第二成分标签量；不是另加一盒他汀或换算指令", "en": "labelled amount of the second ingredient per tablet; not an instruction to add another statin or convert products" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "塑料瓶", "en": "plastic bottle" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-29", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "current_label_lists_marketing_end_date", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 30, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "蓝色", "en": "blue" }, "shape": { "zh": "椭圆形、无刻痕薄膜衣片，约 11 mm；无刻痕不表示可自行掰开或磨碎", "en": "oval, unscored film-coated tablet, approximately 11 mm; an unscored tablet does not establish permission to split or crush it" }, "imprint": "CDT;102", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_22af65532a65996f", "label": "DailyMed（NLM）：CADUET 10/20 mg、NDC 58151-061-93、30 片瓶装美国公开标签面板", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=164394b3-d7ba-4bbf-b64b-e2dd15735ea8", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-caduet-amlodipine-10mg-atorvastatin-40mg-30-bottle-ndc-5815106293", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（2026-06-25 更新；2026-08-29 核验）", "en": "Current U.S. DailyMed public label (updated 25 Jun 2026; verified 29 Aug 2026)" }, "dosageForm": { "zh": "CADUET 氨氯地平/阿托伐他汀薄膜衣口服片", "en": "CADUET amlodipine/atorvastatin film-coated oral tablet" }, "route": { "zh": "口服（固定两成分产品身份字段）", "en": "oral (fixed two-ingredient product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 58151-062-93", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片氨氯地平 10 mg＋阿托伐他汀 40 mg；30 片瓶装", "en": "Amlodipine 10 mg plus atorvastatin 40 mg per tablet; 30-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=caduet-16.jpg&setid=164394b3-d7ba-4bbf-b64b-e2dd15735ea8", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "氨氯地平", "en": "amlodipine" }, "value": 10, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片第一成分标签量；不是个人片数、加量或换算指令", "en": "labelled amount of the first ingredient per tablet; not an individual tablet count, increase or conversion instruction" } }, { "ingredient": { "zh": "阿托伐他汀", "en": "atorvastatin" }, "value": 40, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片第二成分标签量；不是另加一盒他汀或换算指令", "en": "labelled amount of the second ingredient per tablet; not an instruction to add another statin or convert products" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "塑料瓶", "en": "plastic bottle" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-29", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "current_regulatory_listing_not_inventory", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 30, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "蓝色", "en": "blue" }, "shape": { "zh": "椭圆形、无刻痕薄膜衣片，约 14 mm；无刻痕不表示可自行掰开或磨碎", "en": "oval, unscored film-coated tablet, approximately 14 mm; an unscored tablet does not establish permission to split or crush it" }, "imprint": "CDT;104", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_22af65532a65996f", "label": "DailyMed（NLM）：CADUET 10/40 mg、NDC 58151-062-93、30 片瓶装美国公开标签面板", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=164394b3-d7ba-4bbf-b64b-e2dd15735ea8", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-caduet-amlodipine-10mg-atorvastatin-80mg-30-bottle-ndc-5815106393", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（2026-06-25 更新；2026-08-29 核验）", "en": "Current U.S. DailyMed public label (updated 25 Jun 2026; verified 29 Aug 2026)" }, "dosageForm": { "zh": "CADUET 氨氯地平/阿托伐他汀薄膜衣口服片", "en": "CADUET amlodipine/atorvastatin film-coated oral tablet" }, "route": { "zh": "口服（固定两成分产品身份字段）", "en": "oral (fixed two-ingredient product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 58151-063-93", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片氨氯地平 10 mg＋阿托伐他汀 80 mg；30 片瓶装", "en": "Amlodipine 10 mg plus atorvastatin 80 mg per tablet; 30-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=caduet-17.jpg&setid=164394b3-d7ba-4bbf-b64b-e2dd15735ea8", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "氨氯地平", "en": "amlodipine" }, "value": 10, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片第一成分标签量；不是个人片数、加量或换算指令", "en": "labelled amount of the first ingredient per tablet; not an individual tablet count, increase or conversion instruction" } }, { "ingredient": { "zh": "阿托伐他汀", "en": "atorvastatin" }, "value": 80, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片第二成分标签量；不是另加一盒他汀或换算指令", "en": "labelled amount of the second ingredient per tablet; not an instruction to add another statin or convert products" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "塑料瓶", "en": "plastic bottle" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-29", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "current_regulatory_listing_not_inventory", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 30, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "蓝色", "en": "blue" }, "shape": { "zh": "椭圆形、无刻痕薄膜衣片，约 17 mm；无刻痕不表示可自行掰开或磨碎", "en": "oval, unscored film-coated tablet, approximately 17 mm; an unscored tablet does not establish permission to split or crush it" }, "imprint": "CDT;108", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_22af65532a65996f", "label": "DailyMed（NLM）：CADUET 10/80 mg、NDC 58151-063-93、30 片瓶装美国公开标签面板", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=164394b3-d7ba-4bbf-b64b-e2dd15735ea8", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-caduet-amlodipine-5mg-atorvastatin-10mg-30-bottle-ndc-5815106493", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=caduet-10.jpg&setid=164394b3-d7ba-4bbf-b64b-e2dd15735ea8", "alt": { "zh": "DailyMed 当前 CADUET 5/10 mg、NDC 58151-064-93、30 片瓶装标签面板", "en": "Current DailyMed CADUET 5/10 mg, NDC 58151-064-93, 30-tablet bottle label panel" }, "archiveMarket": "美国", "labelVersion": "DailyMed 美国当前公开标签（2026-06-25 更新）", "presentation": "CADUET 氨氯地平 5 mg/阿托伐他汀 10 mg 每片，NDC 58151-064-93，30 片瓶装。", "notice": "此图只对应 CADUET 5/10 mg、NDC 58151-064-93、30 片瓶装面板；不能代表另七个标签包装、三个仅在 Orange Book/历史批准记录中列出的 2.5 mg 组合、其他市场或仿制药，不用于鉴定真伪，也不证明实时库存或可替代性。", "source": { "id": "src_22af65532a65996f", "label": "DailyMed（NLM）：CADUET 5/10 mg、NDC 58151-064-93、30 片瓶装美国公开标签面板", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=164394b3-d7ba-4bbf-b64b-e2dd15735ea8", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "CADUET 说明书放大阅读：一片已有降压药和他汀，先查两条成分是否重复", "en": "CADUET label reading: one tablet already contains a blood-pressure medicine and a statin; check both ingredients for duplication" }, "summary": { "zh": "CADUET 的双数字表示同一片内两种成分。例如 5/40 mg 是氨氯地平 5 mg 加阿托伐他汀 40 mg，不是两片、半片或可以与单方药直接相加的换算式。标签要求两种成分分别评估；网页不会据血压或血脂替个人选择组合。", "en": "The paired numbers identify two ingredients in one CADUET tablet. For example, 5/40 mg means amlodipine 5 mg plus atorvastatin 40 mg; it is not two tablets, half a tablet or a conversion formula for adding single-ingredient products. The label requires each component to be assessed independently; the site does not choose a combination from an individual's blood pressure or lipid result." }, "checks": [ { "zh": "先逐盒核对成分。NORVASC 是单方氨氯地平，LIPITOR 是单方阿托伐他汀；LOTREL、AZOR、EXFORGE、EXFORGE HCT 与 TRIBENZOR 也可能共享氨氯地平。疑似重复可能是误用，也可能是专业人员有意安排，网页无法只凭名称判断；不要自行加上或停掉任何一盒。", "en": "Check active ingredients on every pack. NORVASC is amlodipine alone and LIPITOR is atorvastatin alone; LOTREL, AZOR, EXFORGE, EXFORGE HCT and TRIBENZOR may also share amlodipine. Suspected duplication may be accidental or intentionally prescribed, and the site cannot decide from names alone. Do not add or stop a pack yourself." }, { "zh": "年龄 ≥65 岁、甲状腺功能未控制、肾功能受损、使用某些相互作用药物或较高规格，会增加标签所述肌病和横纹肌溶解风险。出现无法解释的肌痛、压痛或无力，尤其伴发热、全身不适或深色尿，应尽快联系医疗团队；症状严重、迅速加重、意识异常或尿量显著减少时使用当地急救服务。", "en": "Age 65 years or older, uncontrolled hypothyroidism, renal impairment, certain interacting medicines and higher strengths increase the labelled risk of myopathy and rhabdomyolysis. Promptly contact the care team for unexplained muscle pain, tenderness or weakness, especially with fever, malaise or dark urine; use local emergency services for severe or rapidly worsening symptoms, altered consciousness or markedly reduced urine." }, { "zh": "标签列出葡萄柚汁、部分抗病毒药、克拉霉素、伊曲康唑、利福平和地高辛等相互作用边界。不要依据网页自行安排停药、错开时间或改变规格；让药师按准确产品、食物/饮品、补充剂和完整药单核对。", "en": "The label identifies interaction boundaries involving grapefruit juice, some antivirals, clarithromycin, itraconazole, rifampin and digoxin. Do not use the site to stop a medicine, schedule separation or change a strength; have a pharmacist review the exact products, foods or drinks, supplements and complete medicine list." }, { "zh": "严重肝损伤症状、黄疸或明显深色尿需要及时医疗评估。急性肝衰竭或失代偿性肝硬化属于标签禁忌边界；网页不读取化验值来决定继续、暂停或改量。", "en": "Symptoms of serious liver injury, jaundice or markedly dark urine need timely medical assessment. Acute liver failure or decompensated cirrhosis is a labelled contraindication boundary; the site does not read laboratory values to decide continuation, interruption or adjustment." }, { "zh": "开始使用或增加氨氯地平成分时，胸痛可能加重或发生心肌梗死。持续或加重的胸痛、呼吸困难、冷汗、晕厥或突发神经症状应使用当地急救服务，而不是等待网页判断。", "en": "Chest pain may worsen or myocardial infarction may occur when the amlodipine component is started or increased. Use local emergency services for persistent or worsening chest pain, breathing difficulty, cold sweats, fainting or sudden neurological symptoms rather than waiting for a website decision." }, { "zh": "怀孕可能造成胎儿伤害，使用期间不建议哺乳。已经怀孕、可能怀孕、计划怀孕或正在哺乳者应及时联系开方团队核对，不自行停换药。", "en": "Pregnancy may cause fetal harm and breastfeeding is not recommended during treatment. Anyone who is pregnant, may be pregnant, plans pregnancy or is breastfeeding should contact the prescribing team promptly and should not arrange stopping or switching independently." }, { "zh": "八种当前标签片剂均为椭圆形、无刻痕；白色对应氨氯地平 5 mg，蓝色对应 10 mg，但颜色只能作为同一现行标签内的辅助线索。不要仅凭颜色、印字或双数字鉴定真伪、掰片或换药。", "en": "All eight current-label tablets are oval and unscored. White corresponds to amlodipine 5 mg and blue to 10 mg, but colour is only an auxiliary clue within this exact current label. Do not authenticate, split or switch a medicine from colour, imprint or paired numbers alone." } ], "source": { "id": "src_22af65532a65996f", "label": "DailyMed（NLM）：CADUET 氨氯地平/阿托伐他汀当前美国公开标签（2026-06-25 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=164394b3-d7ba-4bbf-b64b-e2dd15735ea8", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "两种成分怎样分工：氨氯地平帮助血管舒张，阿托伐他汀抑制 HMG-CoA 还原酶", "en": "How the two ingredients differ: amlodipine supports arterial relaxation while atorvastatin inhibits HMG-CoA reductase" }, "summary": { "zh": "当前标签把氨氯地平描述为二氢吡啶类钙通道阻滞剂，把阿托伐他汀描述为 HMG-CoA 还原酶选择性、竞争性抑制剂。一片覆盖两条不同路径，不代表网页能用一个血压数或 LDL-C 数字替个人拆分、重组或转换方案。", "en": "The current label describes amlodipine as a dihydropyridine calcium-channel blocker and atorvastatin as a selective, competitive HMG-CoA reductase inhibitor. Two pathways in one tablet do not let the site split, rebuild or convert an individual's regimen from one blood-pressure or LDL-C value." }, "checks": [ { "zh": "氨氯地平成分常见剂量相关水肿，也可能与头晕或低血压有关；阿托伐他汀成分需要关注肌肉、肝脏、相互作用和血糖相关警示。只看到“心血管药”或商品名不足以完成安全核对。", "en": "Amlodipine commonly causes dose-related oedema and may relate to dizziness or hypotension. Atorvastatin requires attention to muscle, liver, interaction and glucose warnings. The words 'cardiovascular medicine' or the brand name alone are not a complete safety review." }, { "zh": "当前 DailyMed 标签列八种 5 或 10 mg 氨氯地平组合；Orange Book 另列三个 2.5 mg 组合。网页保留这一区别，不把监管规格表变成当前包装、个人起始规格或采购清单。", "en": "The current DailyMed label lists eight combinations with amlodipine 5 or 10 mg, while the Orange Book additionally lists three 2.5 mg combinations. The site preserves this distinction and does not turn a regulatory strengths table into current packs, an individual starting strength or a purchasing list." }, { "zh": "同一片里的两条作用路径不能分开停用、分开补服或按单方毫克数拼接。任何改动都要回到准确处方、实际药盒、症状、化验和完整药单，由开方团队或药师判断。", "en": "The two pathways in one tablet cannot be stopped separately, made up separately or reconstructed from single-ingredient milligram numbers. Any change must return to the exact prescription, actual pack, symptoms, laboratory results and complete medicine list for review by the prescribing team or pharmacist." } ], "source": { "id": "src_22af65532a65996f", "label": "DailyMed（NLM）：CADUET 氨氯地平/阿托伐他汀当前美国公开标签（2026-06-25 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=164394b3-d7ba-4bbf-b64b-e2dd15735ea8", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "CADUET", "generic": "氨氯地平/阿托伐他汀片", "dosageFormClass": "氨氯地平/阿托伐他汀固定两成分薄膜衣口服片：当前标签八个 5 或 10 mg／10、20、40 或 80 mg 组合；每组两个数字属于同一片内两种成分" }, "labelSource": { "id": "src_22af65532a65996f", "label": "DailyMed（NLM）：CADUET 氨氯地平/阿托伐他汀当前美国公开标签（2026-06-25 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=164394b3-d7ba-4bbf-b64b-e2dd15735ea8", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "productRoutes": [ { "source": { "id": "src_22af65532a65996f", "label": "DailyMed（NLM）：CADUET 氨氯地平/阿托伐他汀当前美国公开标签（2026-06-25 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=164394b3-d7ba-4bbf-b64b-e2dd15735ea8", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-29", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_10e511bf83430e3b", "label": "FDA Orange Book 当前数据：CADUET，NDA 021540，11 个口服片规格列为处方 RLD；10/80 mg 同时列为 RS", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-08-29", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_9ddcb06f7196a1e3", "label": "FDA Drugs@FDA 官方检索入口：CADUET NDA 021540 申请与标签记录", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-08-29", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-29", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "CADUET 一片同时含氨氯地平和阿托伐他汀：前一个数字是氨氯地平，后一个数字是阿托伐他汀。它既不是单方 NORVASC，也不是单方 LIPITOR。若药单还出现这些单方药，或 LOTREL、AZOR、EXFORGE、EXFORGE HCT、TRIBENZOR 等共享氨氯地平的复方，应带所有药盒、处方和完整药单让药师或开方团队逐项核对，不要自行叠加、停药、轮换、掰片或按毫克换算。", "history": "FDA 于 2004-01-30 批准 CADUET NDA 021540 的八个 5/10 至 10/80 mg 组合，同年 2004-07-29 的 S-003 批准函增列 2.5/10、2.5/20 和 2.5/40 mg。当前 Orange Book 数据仍列 11 个处方 RLD 规格并把 10/80 mg 列为 RS；当前 DailyMed 标签页面则列八个 5 或 10 mg 氨氯地平组合包装。两类官方记录用途不同，不能据此推断每个规格实时供应。", "sourceDocuments": [ { "id": "src_22af65532a65996f", "label": "DailyMed（NLM）：CADUET 氨氯地平/阿托伐他汀当前美国公开标签（2026-06-25 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=164394b3-d7ba-4bbf-b64b-e2dd15735ea8", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, { "id": "src_10e511bf83430e3b", "label": "FDA Orange Book 当前数据：CADUET，NDA 021540，11 个口服片规格列为处方 RLD；10/80 mg 同时列为 RS", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, { "id": "src_9ddcb06f7196a1e3", "label": "FDA Drugs@FDA 官方检索入口：CADUET NDA 021540 申请与标签记录", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, { "id": "src_f3bb45ec1fe785d0", "label": "FDA：CADUET NDA 021540 原始批准函（2004-01-30）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21540ltr.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_regulatory_record", "documentKind": "regulatory_review", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_pdf", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, { "id": "src_34a1d55a2d52039e", "label": "FDA：CADUET NDA 021540/S-003 增列 2.5 mg 氨氯地平组合规格批准函（2004-07-29）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21540s003ltr.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_regulatory_record", "documentKind": "regulatory_review", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_pdf", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } ], "applicationNumber": "FDA NDA 021540（CADUET / amlodipine and atorvastatin oral tablets）", "approvalTimeline": [ { "date": "2004-01-30", "title": { "zh": "CADUET 原始批准", "en": "Original CADUET approval" }, "detail": { "zh": "FDA 原始批准函列出八个 5/10 至 10/80 mg 固定复方规格。", "en": "The FDA original approval letter lists eight fixed-combination strengths from 5/10 through 10/80 mg." }, "source": { "id": "src_f3bb45ec1fe785d0", "label": "FDA：CADUET NDA 021540 原始批准函（2004-01-30）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21540ltr.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_regulatory_record", "documentKind": "regulatory_review", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_pdf", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } }, { "date": "2004-07-29", "title": { "zh": "增列三种 2.5 mg 氨氯地平组合", "en": "Three 2.5 mg amlodipine combinations added" }, "detail": { "zh": "FDA S-003 批准函增列 2.5/10、2.5/20 和 2.5/40 mg；当前 DailyMed 标签未展示这三个包装。", "en": "The FDA S-003 approval letter added 2.5/10, 2.5/20 and 2.5/40 mg; the current DailyMed label does not display these three packs." }, "source": { "id": "src_34a1d55a2d52039e", "label": "FDA：CADUET NDA 021540/S-003 增列 2.5 mg 氨氯地平组合规格批准函（2004-07-29）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21540s003ltr.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_regulatory_record", "documentKind": "regulatory_review", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_pdf", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } }, { "date": "2026-06-25", "title": { "zh": "当前 DailyMed 页面更新", "en": "Current DailyMed page updated" }, "detail": { "zh": "页面列八个规格、八个准确 30 片瓶装面板、NDC、外观和放大安全信息。", "en": "The page lists eight strengths, eight exact 30-tablet bottle panels, NDCs, appearances and enlarged safety information." }, "source": { "id": "src_22af65532a65996f", "label": "DailyMed（NLM）：CADUET 氨氯地平/阿托伐他汀当前美国公开标签（2026-06-25 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=164394b3-d7ba-4bbf-b64b-e2dd15735ea8", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } }, { "date": "2026-08-28", "title": { "zh": "Orange Book 身份核验", "en": "Orange Book identity reviewed" }, "detail": { "zh": "当前数据列 11 个处方 RLD 规格，并将 10/80 mg 列为 RS。", "en": "Current data list 11 prescription RLD strengths and identify 10/80 mg as the RS." }, "source": { "id": "src_10e511bf83430e3b", "label": "FDA Orange Book 当前数据：CADUET，NDA 021540，11 个口服片规格列为处方 RLD；10/80 mg 同时列为 RS", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "Orange Book 列 11 个处方 RLD 规格；10/80 mg 同时为 RS；当前 DailyMed 标签展示八个包装", "en": "Orange Book lists 11 prescription RLD strengths; 10/80 mg is also RS; current DailyMed label displays eight packs" }, "detail": { "zh": "10/10 与 10/20 mg 标签 NDC 条目列有同日营销起止日期；任何条目都不等于药房实时库存、购买资格或可替代性。", "en": "The 10/10 and 10/20 mg label NDC entries list same-day marketing start and end dates. No entry establishes real-time pharmacy stock, purchasing eligibility or interchangeability." } }, { "market": { "zh": "中国大陆及其他市场", "en": "Mainland China and other markets" }, "status": { "zh": "待逐项建立现行市场记录", "en": "Current market record not established" }, "detail": { "zh": "不从美国品牌、共同成分或双数字推定当地批准、商品名、包装、供应或可替代性。", "en": "No local approval, trade name, pack, supply or interchangeability is inferred from the U.S. brand, shared ingredients or paired numbers." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "CADUET 是 NORVASC 加 LIPITOR 吗？", "en": "Is CADUET the same as NORVASC plus LIPITOR?" }, "answer": { "zh": "CADUET 一片确实含与这两个单方品牌相对应的氨氯地平和阿托伐他汀，但准确规格、标签、处方和个体安排必须逐项核对。不要自行把两盒单方替换成 CADUET，或在 CADUET 上再叠加单方。", "en": "One CADUET tablet contains amlodipine and atorvastatin, corresponding to the ingredients in those two single-ingredient brands, but exact strengths, labels, prescriptions and individual plans must be reviewed. Do not replace two single-ingredient packs with CADUET or add them to CADUET yourself." } }, { "question": { "zh": "为什么 Orange Book 有 11 个规格，而当前说明书只有八个包装？", "en": "Why does the Orange Book have 11 strengths while the current label has only eight packs?" }, "answer": { "zh": "Orange Book 还列出 2004 年增列的三个 2.5 mg 氨氯地平组合；当前 DailyMed 页面只展示 5 mg 与 10 mg 氨氯地平组合。监管身份记录、当前标签包装和实时供应是三件不同的事。", "en": "The Orange Book also lists three 2.5 mg amlodipine combinations added in 2004, while the current DailyMed page displays combinations with amlodipine 5 or 10 mg. Regulatory identity, current label packs and real-time supply are different things." } }, { "question": { "zh": "腿肿或肌肉痛时能自己停其中一个成分吗？", "en": "Can one component be stopped independently for leg swelling or muscle pain?" }, "answer": { "zh": "不能把固定复方片拆成两个可独立停用的成分。腿或踝水肿、无法解释的肌痛、压痛或无力都应带准确药盒和完整药单联系医疗团队；严重胸痛、呼吸困难、晕厥、意识异常或尿量显著减少时使用当地急救服务。", "en": "A fixed-combination tablet cannot be separated into components that can be stopped independently. Leg or ankle oedema, unexplained muscle pain, tenderness or weakness warrant contact with the care team with the exact pack and full medicine list. Use local emergency services for severe chest pain, breathing difficulty, fainting, altered consciousness or markedly reduced urine." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "how-to-read-a-drug-label", "dosage-forms-are-part-of-medicine-identity" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/caduet/", "en": "https://origindrug.com/en/drugs/caduet/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "vytorin", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-29", "status": "published_traceable_archive" }, "names": { "brand": "VYTORIN", "generic": "依折麦布/辛伐他汀片", "aliases": [ "Vytorin", "ezetimibe simvastatin", "ezetimibe and simvastatin", "ezetimibe/simvastatin", "依折麦布辛伐他汀", "依折麦布辛伐他汀片", "依折麦布/辛伐他汀", "NDA 021687", "78206-174-01", "78206-174-02", "78206-175-01", "78206-175-02", "78206-176-01", "78206-176-02", "78206-177-01", "78206-177-02", "VYTORIN 311", "VYTORIN 312", "VYTORIN 313", "VYTORIN 315" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "心血管", "sourceArchiveMarket": "美国：DailyMed 当前 VYTORIN 标签（2026-01-21 更新；标签正文 2024-03 修订）列示依折麦布 10 mg 与辛伐他汀 10、20、40 或 80 mg 的四个固定复方规格、八个 30 或 90 片瓶装 NDC；页面只为四个 30 片瓶装提供官方展示图，90 片瓶装保留标签文字身份卡。FDA Orange Book 2026-08-28 数据将 NDA 021687 四个规格均列为处方 RLD，并将 10/80 mg 列为 RS。监管记录、标签包装、图片和实时供应是不同证据层级。", "dosageFormClass": "依折麦布/辛伐他汀固定两成分口服片：10/10、10/20、10/40、10/80 mg；每组两个数字属于同一片内两种成分；当前标签分别列 30 与 90 片瓶装", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "2004", "archiveSponsorText": "Organon LLC（DailyMed 当前标签及 FDA Orange Book 当前申请记录）" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [ "ZETIA", "ezetimibe tablet", "ZOCOR", "simvastatin tablet", "LIPITOR", "CRESTOR", "LIVALO", "CADUET" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-vytorin-ezetimibe-10mg-simvastatin-10mg-30-bottle-ndc-7820617401", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（2026-01-21 更新；标签正文 2024-03 修订；2026-08-29 核验）", "en": "Current U.S. DailyMed public label (updated 21 Jan 2026; label revised Mar 2024; verified 29 Aug 2026)" }, "dosageForm": { "zh": "VYTORIN 依折麦布/辛伐他汀口服片", "en": "VYTORIN ezetimibe/simvastatin oral tablet" }, "route": { "zh": "口服（固定两成分产品身份字段）", "en": "oral (fixed two-ingredient product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 78206-174-01", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片依折麦布 10 mg＋辛伐他汀 10 mg；30 片瓶装", "en": "Ezetimibe 10 mg plus simvastatin 10 mg per tablet; 30-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=vytorin-04.jpg&setid=89b860d2-de83-468e-b7e8-76aeec2edca2", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "依折麦布", "en": "ezetimibe" }, "value": 10, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片第一成分标签量；不是另加 ZETIA、换药或个人片数指令", "en": "labelled amount of the first ingredient per tablet; not an instruction to add ZETIA, switch products or choose a tablet count" } }, { "ingredient": { "zh": "辛伐他汀", "en": "simvastatin" }, "value": 10, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片第二成分标签量；不是另加 ZOCOR、其他他汀或按毫克换算指令", "en": "labelled amount of the second ingredient per tablet; not an instruction to add ZOCOR, another statin or convert by milligrams" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-29", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "current_regulatory_listing_not_inventory", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 30, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "白色至类白色", "en": "white to off-white" }, "shape": { "zh": "胶囊形、无刻痕片，约 8 mm；无刻痕不表示可自行掰开或磨碎", "en": "capsule-shaped, unscored tablet, approximately 8 mm; an unscored tablet does not establish permission to split or crush it" }, "imprint": "311", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_9ab0b8fb69230ecf", "label": "DailyMed（NLM）：VYTORIN 10/10 mg、NDC 78206-174-01、30 片瓶装美国公开标签面板", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=89b860d2-de83-468e-b7e8-76aeec2edca2", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-vytorin-ezetimibe-10mg-simvastatin-10mg-90-bottle-ndc-7820617402", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（2026-01-21 更新；标签正文 2024-03 修订；2026-08-29 核验）", "en": "Current U.S. DailyMed public label (updated 21 Jan 2026; label revised Mar 2024; verified 29 Aug 2026)" }, "dosageForm": { "zh": "VYTORIN 依折麦布/辛伐他汀口服片", "en": "VYTORIN ezetimibe/simvastatin oral tablet" }, "route": { "zh": "口服（固定两成分产品身份字段）", "en": "oral (fixed two-ingredient product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 78206-174-02", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片依折麦布 10 mg＋辛伐他汀 10 mg；90 片瓶装", "en": "Ezetimibe 10 mg plus simvastatin 10 mg per tablet; 90-tablet bottle" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "依折麦布", "en": "ezetimibe" }, "value": 10, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片第一成分标签量；不是另加 ZETIA、换药或个人片数指令", "en": "labelled amount of the first ingredient per tablet; not an instruction to add ZETIA, switch products or choose a tablet count" } }, { "ingredient": { "zh": "辛伐他汀", "en": "simvastatin" }, "value": 10, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片第二成分标签量；不是另加 ZOCOR、其他他汀或按毫克换算指令", "en": "labelled amount of the second ingredient per tablet; not an instruction to add ZOCOR, another statin or convert by milligrams" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 90, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-29", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "current_regulatory_listing_not_inventory", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 90, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "白色至类白色", "en": "white to off-white" }, "shape": { "zh": "胶囊形、无刻痕片，约 8 mm；无刻痕不表示可自行掰开或磨碎", "en": "capsule-shaped, unscored tablet, approximately 8 mm; an unscored tablet does not establish permission to split or crush it" }, "imprint": "311", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_9ab0b8fb69230ecf", "label": "DailyMed（NLM）：VYTORIN 10/10 mg、NDC 78206-174-02、90 片瓶装美国公开标签文字身份记录", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=89b860d2-de83-468e-b7e8-76aeec2edca2", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-vytorin-ezetimibe-10mg-simvastatin-20mg-30-bottle-ndc-7820617501", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（2026-01-21 更新；标签正文 2024-03 修订；2026-08-29 核验）", "en": "Current U.S. DailyMed public label (updated 21 Jan 2026; label revised Mar 2024; verified 29 Aug 2026)" }, "dosageForm": { "zh": "VYTORIN 依折麦布/辛伐他汀口服片", "en": "VYTORIN ezetimibe/simvastatin oral tablet" }, "route": { "zh": "口服（固定两成分产品身份字段）", "en": "oral (fixed two-ingredient product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 78206-175-01", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片依折麦布 10 mg＋辛伐他汀 20 mg；30 片瓶装", "en": "Ezetimibe 10 mg plus simvastatin 20 mg per tablet; 30-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=vytorin-05.jpg&setid=89b860d2-de83-468e-b7e8-76aeec2edca2", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "依折麦布", "en": "ezetimibe" }, "value": 10, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片第一成分标签量；不是另加 ZETIA、换药或个人片数指令", "en": "labelled amount of the first ingredient per tablet; not an instruction to add ZETIA, switch products or choose a tablet count" } }, { "ingredient": { "zh": "辛伐他汀", "en": "simvastatin" }, "value": 20, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片第二成分标签量；不是另加 ZOCOR、其他他汀或按毫克换算指令", "en": "labelled amount of the second ingredient per tablet; not an instruction to add ZOCOR, another statin or convert by milligrams" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-29", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "current_regulatory_listing_not_inventory", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 30, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "白色至类白色", "en": "white to off-white" }, "shape": { "zh": "胶囊形、无刻痕片，约 11 mm；无刻痕不表示可自行掰开或磨碎", "en": "capsule-shaped, unscored tablet, approximately 11 mm; an unscored tablet does not establish permission to split or crush it" }, "imprint": "312", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_9ab0b8fb69230ecf", "label": "DailyMed（NLM）：VYTORIN 10/20 mg、NDC 78206-175-01、30 片瓶装美国公开标签面板", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=89b860d2-de83-468e-b7e8-76aeec2edca2", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-vytorin-ezetimibe-10mg-simvastatin-20mg-90-bottle-ndc-7820617502", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（2026-01-21 更新；标签正文 2024-03 修订；2026-08-29 核验）", "en": "Current U.S. DailyMed public label (updated 21 Jan 2026; label revised Mar 2024; verified 29 Aug 2026)" }, "dosageForm": { "zh": "VYTORIN 依折麦布/辛伐他汀口服片", "en": "VYTORIN ezetimibe/simvastatin oral tablet" }, "route": { "zh": "口服（固定两成分产品身份字段）", "en": "oral (fixed two-ingredient product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 78206-175-02", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片依折麦布 10 mg＋辛伐他汀 20 mg；90 片瓶装", "en": "Ezetimibe 10 mg plus simvastatin 20 mg per tablet; 90-tablet bottle" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "依折麦布", "en": "ezetimibe" }, "value": 10, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片第一成分标签量；不是另加 ZETIA、换药或个人片数指令", "en": "labelled amount of the first ingredient per tablet; not an instruction to add ZETIA, switch products or choose a tablet count" } }, { "ingredient": { "zh": "辛伐他汀", "en": "simvastatin" }, "value": 20, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片第二成分标签量；不是另加 ZOCOR、其他他汀或按毫克换算指令", "en": "labelled amount of the second ingredient per tablet; not an instruction to add ZOCOR, another statin or convert by milligrams" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 90, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-29", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "current_regulatory_listing_not_inventory", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 90, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "白色至类白色", "en": "white to off-white" }, "shape": { "zh": "胶囊形、无刻痕片，约 11 mm；无刻痕不表示可自行掰开或磨碎", "en": "capsule-shaped, unscored tablet, approximately 11 mm; an unscored tablet does not establish permission to split or crush it" }, "imprint": "312", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_9ab0b8fb69230ecf", "label": "DailyMed（NLM）：VYTORIN 10/20 mg、NDC 78206-175-02、90 片瓶装美国公开标签文字身份记录", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=89b860d2-de83-468e-b7e8-76aeec2edca2", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-vytorin-ezetimibe-10mg-simvastatin-40mg-30-bottle-ndc-7820617601", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（2026-01-21 更新；标签正文 2024-03 修订；2026-08-29 核验）", "en": "Current U.S. DailyMed public label (updated 21 Jan 2026; label revised Mar 2024; verified 29 Aug 2026)" }, "dosageForm": { "zh": "VYTORIN 依折麦布/辛伐他汀口服片", "en": "VYTORIN ezetimibe/simvastatin oral tablet" }, "route": { "zh": "口服（固定两成分产品身份字段）", "en": "oral (fixed two-ingredient product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 78206-176-01", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片依折麦布 10 mg＋辛伐他汀 40 mg；30 片瓶装", "en": "Ezetimibe 10 mg plus simvastatin 40 mg per tablet; 30-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=vytorin-06.jpg&setid=89b860d2-de83-468e-b7e8-76aeec2edca2", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "依折麦布", "en": "ezetimibe" }, "value": 10, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片第一成分标签量；不是另加 ZETIA、换药或个人片数指令", "en": "labelled amount of the first ingredient per tablet; not an instruction to add ZETIA, switch products or choose a tablet count" } }, { "ingredient": { "zh": "辛伐他汀", "en": "simvastatin" }, "value": 40, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片第二成分标签量；不是另加 ZOCOR、其他他汀或按毫克换算指令", "en": "labelled amount of the second ingredient per tablet; not an instruction to add ZOCOR, another statin or convert by milligrams" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-29", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "current_regulatory_listing_not_inventory", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 30, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "白色至类白色", "en": "white to off-white" }, "shape": { "zh": "胶囊形、无刻痕片，约 14 mm；无刻痕不表示可自行掰开或磨碎", "en": "capsule-shaped, unscored tablet, approximately 14 mm; an unscored tablet does not establish permission to split or crush it" }, "imprint": "313", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_9ab0b8fb69230ecf", "label": "DailyMed（NLM）：VYTORIN 10/40 mg、NDC 78206-176-01、30 片瓶装美国公开标签面板", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=89b860d2-de83-468e-b7e8-76aeec2edca2", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-vytorin-ezetimibe-10mg-simvastatin-40mg-90-bottle-ndc-7820617602", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（2026-01-21 更新；标签正文 2024-03 修订；2026-08-29 核验）", "en": "Current U.S. DailyMed public label (updated 21 Jan 2026; label revised Mar 2024; verified 29 Aug 2026)" }, "dosageForm": { "zh": "VYTORIN 依折麦布/辛伐他汀口服片", "en": "VYTORIN ezetimibe/simvastatin oral tablet" }, "route": { "zh": "口服（固定两成分产品身份字段）", "en": "oral (fixed two-ingredient product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 78206-176-02", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片依折麦布 10 mg＋辛伐他汀 40 mg；90 片瓶装", "en": "Ezetimibe 10 mg plus simvastatin 40 mg per tablet; 90-tablet bottle" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "依折麦布", "en": "ezetimibe" }, "value": 10, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片第一成分标签量；不是另加 ZETIA、换药或个人片数指令", "en": "labelled amount of the first ingredient per tablet; not an instruction to add ZETIA, switch products or choose a tablet count" } }, { "ingredient": { "zh": "辛伐他汀", "en": "simvastatin" }, "value": 40, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片第二成分标签量；不是另加 ZOCOR、其他他汀或按毫克换算指令", "en": "labelled amount of the second ingredient per tablet; not an instruction to add ZOCOR, another statin or convert by milligrams" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 90, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-29", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "current_regulatory_listing_not_inventory", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 90, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "白色至类白色", "en": "white to off-white" }, "shape": { "zh": "胶囊形、无刻痕片，约 14 mm；无刻痕不表示可自行掰开或磨碎", "en": "capsule-shaped, unscored tablet, approximately 14 mm; an unscored tablet does not establish permission to split or crush it" }, "imprint": "313", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_9ab0b8fb69230ecf", "label": "DailyMed（NLM）：VYTORIN 10/40 mg、NDC 78206-176-02、90 片瓶装美国公开标签文字身份记录", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=89b860d2-de83-468e-b7e8-76aeec2edca2", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-vytorin-ezetimibe-10mg-simvastatin-80mg-30-bottle-ndc-7820617701", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（2026-01-21 更新；标签正文 2024-03 修订；2026-08-29 核验）", "en": "Current U.S. DailyMed public label (updated 21 Jan 2026; label revised Mar 2024; verified 29 Aug 2026)" }, "dosageForm": { "zh": "VYTORIN 依折麦布/辛伐他汀口服片", "en": "VYTORIN ezetimibe/simvastatin oral tablet" }, "route": { "zh": "口服（固定两成分产品身份字段）", "en": "oral (fixed two-ingredient product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 78206-177-01", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片依折麦布 10 mg＋辛伐他汀 80 mg；30 片瓶装", "en": "Ezetimibe 10 mg plus simvastatin 80 mg per tablet; 30-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=vytorin-07.jpg&setid=89b860d2-de83-468e-b7e8-76aeec2edca2", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "依折麦布", "en": "ezetimibe" }, "value": 10, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片第一成分标签量；不是另加 ZETIA、换药或个人片数指令", "en": "labelled amount of the first ingredient per tablet; not an instruction to add ZETIA, switch products or choose a tablet count" } }, { "ingredient": { "zh": "辛伐他汀", "en": "simvastatin" }, "value": 80, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片第二成分标签量；不是另加 ZOCOR、其他他汀或按毫克换算指令", "en": "labelled amount of the second ingredient per tablet; not an instruction to add ZOCOR, another statin or convert by milligrams" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-29", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "current_regulatory_listing_not_inventory", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 30, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "白色至类白色", "en": "white to off-white" }, "shape": { "zh": "胶囊形、无刻痕片，约 17 mm；无刻痕不表示可自行掰开或磨碎", "en": "capsule-shaped, unscored tablet, approximately 17 mm; an unscored tablet does not establish permission to split or crush it" }, "imprint": "315", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_9ab0b8fb69230ecf", "label": "DailyMed（NLM）：VYTORIN 10/80 mg、NDC 78206-177-01、30 片瓶装美国公开标签面板", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=89b860d2-de83-468e-b7e8-76aeec2edca2", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-vytorin-ezetimibe-10mg-simvastatin-80mg-90-bottle-ndc-7820617702", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（2026-01-21 更新；标签正文 2024-03 修订；2026-08-29 核验）", "en": "Current U.S. DailyMed public label (updated 21 Jan 2026; label revised Mar 2024; verified 29 Aug 2026)" }, "dosageForm": { "zh": "VYTORIN 依折麦布/辛伐他汀口服片", "en": "VYTORIN ezetimibe/simvastatin oral tablet" }, "route": { "zh": "口服（固定两成分产品身份字段）", "en": "oral (fixed two-ingredient product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 78206-177-02", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片依折麦布 10 mg＋辛伐他汀 80 mg；90 片瓶装", "en": "Ezetimibe 10 mg plus simvastatin 80 mg per tablet; 90-tablet bottle" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "依折麦布", "en": "ezetimibe" }, "value": 10, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片第一成分标签量；不是另加 ZETIA、换药或个人片数指令", "en": "labelled amount of the first ingredient per tablet; not an instruction to add ZETIA, switch products or choose a tablet count" } }, { "ingredient": { "zh": "辛伐他汀", "en": "simvastatin" }, "value": 80, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片第二成分标签量；不是另加 ZOCOR、其他他汀或按毫克换算指令", "en": "labelled amount of the second ingredient per tablet; not an instruction to add ZOCOR, another statin or convert by milligrams" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 90, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-29", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "current_regulatory_listing_not_inventory", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 90, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "白色至类白色", "en": "white to off-white" }, "shape": { "zh": "胶囊形、无刻痕片，约 17 mm；无刻痕不表示可自行掰开或磨碎", "en": "capsule-shaped, unscored tablet, approximately 17 mm; an unscored tablet does not establish permission to split or crush it" }, "imprint": "315", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_9ab0b8fb69230ecf", "label": "DailyMed（NLM）：VYTORIN 10/80 mg、NDC 78206-177-02、90 片瓶装美国公开标签文字身份记录", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=89b860d2-de83-468e-b7e8-76aeec2edca2", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-vytorin-ezetimibe-10mg-simvastatin-10mg-30-bottle-ndc-7820617401", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=vytorin-04.jpg&setid=89b860d2-de83-468e-b7e8-76aeec2edca2", "alt": { "zh": "DailyMed 当前 VYTORIN 10/10 mg、NDC 78206-174-01、30 片瓶装标签面板", "en": "Current DailyMed VYTORIN 10/10 mg, NDC 78206-174-01, 30-tablet bottle label panel" }, "archiveMarket": "美国", "labelVersion": "DailyMed 美国当前公开标签（2026-01-21 更新；标签正文 2024-03 修订）", "presentation": "VYTORIN 依折麦布 10 mg/辛伐他汀 10 mg 每片，NDC 78206-174-01，30 片瓶装。", "notice": "此图只对应 VYTORIN 10/10 mg、NDC 78206-174-01、30 片瓶装；不能代表另三个 30 片包装、四个没有独立官方展示图的 90 片包装、其他市场或仿制药，不用于鉴定真伪，也不证明实时库存或可替代性。", "source": { "id": "src_9ab0b8fb69230ecf", "label": "DailyMed（NLM）：VYTORIN 10/10 mg、NDC 78206-174-01、30 片瓶装美国公开标签面板", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=89b860d2-de83-468e-b7e8-76aeec2edca2", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } }, "visualCoverageNote": { "status": "partial_exact_visual_coverage", "title": { "zh": "部分包装只有文字身份记录", "en": "Some pack presentations have text-only identity records" }, "summary": { "zh": "当前标签只为四个 30 片瓶装提供准确官方展示图；四个 90 片瓶装虽然有独立 NDC 和标签文字，但没有对应独立展示图，因此网页明确显示为文字身份卡。", "en": "The current label provides exact official display images only for the four 30-tablet bottles. The four 90-tablet bottles have distinct NDCs and label text but no matching display images, so the site explicitly presents them as text-only identity cards." }, "source": { "id": "src_9ab0b8fb69230ecf", "label": "DailyMed（NLM）：VYTORIN 依折麦布/辛伐他汀当前美国公开标签（2026-01-21 更新；标签正文 2024-03 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=89b860d2-de83-468e-b7e8-76aeec2edca2", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } }, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "VYTORIN 说明书放大阅读：一片已有依折麦布和辛伐他汀，先查是否重复降脂成分", "en": "VYTORIN label reading: one tablet already contains ezetimibe and simvastatin; first check for duplicate lipid-lowering ingredients" }, "summary": { "zh": "VYTORIN 的双数字表示同一片内两种成分。例如 10/40 mg 是依折麦布 10 mg 加辛伐他汀 40 mg，不是两片、半片或与单方药直接相加的换算式。标签要求结合完整药单、年龄、肾肝功能、甲状腺情况和相互作用逐项评估；网页不会替个人选择规格。", "en": "The paired numbers identify two ingredients in one VYTORIN tablet. For example, 10/40 mg means ezetimibe 10 mg plus simvastatin 40 mg; it is not two tablets, half a tablet or a conversion formula for adding single-ingredient products. The label requires review of the full medicine list, age, kidney and liver function, thyroid status and interactions; the site does not choose an individual strength." }, "checks": [ { "zh": "先逐盒核对成分。ZETIA 是单方依折麦布，ZOCOR 是单方辛伐他汀；LIPITOR、CRESTOR、LIVALO 与 CADUET 还含其他他汀。疑似重复可能是误用，也可能是专业人员有意安排；不要自行叠加、隔天轮换或停掉任何一盒。", "en": "Check active ingredients on every pack. ZETIA is ezetimibe alone and ZOCOR is simvastatin alone; LIPITOR, CRESTOR, LIVALO and CADUET contain other statins. Suspected duplication may be accidental or intentionally prescribed. Do not combine, alternate by day or stop a pack yourself." }, { "zh": "年龄 ≥65 岁、甲状腺功能未控制、肾功能受损、使用某些相互作用药物或较高规格，会增加标签所述肌病和横纹肌溶解风险；当前标签还提示中国患者风险可能更高。出现无法解释的肌痛、压痛或无力，尤其伴发热、全身不适或深色尿，应尽快联系医疗团队；症状严重、迅速加重、意识异常或尿量显著减少时使用当地急救服务。", "en": "Age 65 years or older, uncontrolled hypothyroidism, renal impairment, certain interacting medicines and higher strengths increase the labelled risk of myopathy and rhabdomyolysis; the current label also says Chinese patients may be at higher risk. Promptly contact the care team for unexplained muscle pain, tenderness or weakness, especially with fever, malaise or dark urine; use local emergency services for severe or rapidly worsening symptoms, altered consciousness or markedly reduced urine." }, { "zh": "10/80 mg 在当前标签和 Orange Book 中仍有记录，但标签把它限制在特定长期耐受情形，并明确较高规格有更高肌病风险。网页不会把 RS 身份或包装存在解释为适合开始、升级或继续该规格。", "en": "The current label and Orange Book still record 10/80 mg, but the label restricts it to defined chronic-tolerance circumstances and states that higher strengths carry greater myopathy risk. The site does not interpret RS status or pack existence as permission to start, increase to or continue this strength." }, { "zh": "当前标签列出强 CYP3A4 抑制剂、环孢素、达那唑、吉非贝齐、胺碘酮、地尔硫卓、氨氯地平、秋水仙碱和葡萄柚汁等重要相互作用边界。不要依据网页自行停药、错开时间或改变规格；让药师按准确产品、食物/饮品、补充剂和完整药单核对。", "en": "The current label identifies important interaction boundaries involving strong CYP3A4 inhibitors, cyclosporine, danazol, gemfibrozil, amiodarone, diltiazem, amlodipine, colchicine and grapefruit juice. Do not use the site to stop a medicine, schedule separation or change a strength; have a pharmacist review the exact products, foods or drinks, supplements and complete medicine list." }, { "zh": "急性肝衰竭或失代偿性肝硬化属于标签禁忌边界。明显乏力、食欲下降、右上腹不适、深色尿或黄疸需要及时医疗评估；网页不读取化验值来决定继续、暂停或改量。", "en": "Acute liver failure or decompensated cirrhosis is a labelled contraindication boundary. Marked fatigue, loss of appetite, right-upper-abdominal discomfort, dark urine or jaundice needs timely medical assessment; the site does not read laboratory values to decide continuation, interruption or adjustment." }, { "zh": "怀孕可能造成胎儿伤害，使用期间不建议哺乳。已经怀孕、可能怀孕、计划怀孕或正在哺乳者应及时联系开方团队核对，不自行停换药。", "en": "Pregnancy may cause fetal harm and breastfeeding is not recommended during treatment. Anyone who is pregnant, may be pregnant, plans pregnancy or is breastfeeding should contact the prescribing team promptly and should not arrange stopping or switching independently." }, { "zh": "四种片剂均为白色至类白色、胶囊形且无刻痕，印字分别为 311、312、313、315。印字只帮助区分标签内规格，不能单独鉴定真伪；无刻痕也不表示可以自行掰开或磨碎。", "en": "All four tablets are white to off-white, capsule-shaped and unscored, with imprints 311, 312, 313 and 315. Imprints only help distinguish strengths within this label and cannot authenticate a product alone; unscored tablets do not establish permission to split or crush them." } ], "source": { "id": "src_9ab0b8fb69230ecf", "label": "DailyMed（NLM）：VYTORIN 依折麦布/辛伐他汀当前美国公开标签（2026-01-21 更新；标签正文 2024-03 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=89b860d2-de83-468e-b7e8-76aeec2edca2", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "两种成分怎样分工：依折麦布减少小肠胆固醇吸收，辛伐他汀影响肝脏胆固醇合成路径", "en": "How the two ingredients differ: ezetimibe reduces intestinal cholesterol absorption while simvastatin acts on the hepatic cholesterol-synthesis pathway" }, "summary": { "zh": "当前标签把依折麦布描述为在小肠刷状缘抑制 NPC1L1 介导的胆固醇吸收，把辛伐他汀描述为经活化后抑制 HMG-CoA 还原酶。两条互补路径在一片中组合，不表示所有人都需要复方，也不允许把其他他汀或单方依折麦布自行拼接成同一方案。", "en": "The current label describes ezetimibe as inhibiting NPC1L1-mediated cholesterol absorption at the intestinal brush border and simvastatin as inhibiting HMG-CoA reductase after activation. Two complementary pathways in one tablet do not mean everyone needs the combination or permit self-assembly from another statin and single-ingredient ezetimibe." }, "checks": [ { "zh": "依折麦布作用于胆固醇吸收路径，辛伐他汀作用于胆固醇合成路径；作用点不同不等于副作用互相抵消，也不等于可以在其他他汀上自行加药。", "en": "Ezetimibe acts on cholesterol absorption and simvastatin on cholesterol synthesis. Different targets do not cancel adverse effects or permit self-adding the medicine to another statin." }, { "zh": "四个强度的依折麦布成分均为每片 10 mg，变化的是辛伐他汀成分。不能只看前一个或后一个数字判断等效，更不能按总毫克数与 CADUET、LIPITOR、CRESTOR 或 ZOCOR 换算。", "en": "The ezetimibe component is 10 mg per tablet in all four strengths; the simvastatin component changes. Neither number nor their total establishes equivalence, and they cannot be converted by milligrams to CADUET, LIPITOR, CRESTOR or ZOCOR." }, { "zh": "基因结果可能在特定临床场景帮助专业人员理解他汀暴露或肌病风险，但网页不会据商品名推荐全基因筛查，也不会用单一基因结果替代完整药单、症状、肾肝功能和临床评估。", "en": "Genetic results may help professionals interpret statin exposure or myopathy risk in defined clinical settings, but the site does not recommend broad genetic screening from a brand name or replace the full medicine list, symptoms, kidney and liver function and clinical assessment with one genetic result." } ], "source": { "id": "src_9ab0b8fb69230ecf", "label": "DailyMed（NLM）：VYTORIN 依折麦布/辛伐他汀当前美国公开标签（2026-01-21 更新；标签正文 2024-03 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=89b860d2-de83-468e-b7e8-76aeec2edca2", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "VYTORIN", "generic": "依折麦布/辛伐他汀片", "dosageFormClass": "依折麦布/辛伐他汀固定两成分口服片：10/10、10/20、10/40、10/80 mg；每组两个数字属于同一片内两种成分；当前标签分别列 30 与 90 片瓶装" }, "labelSource": { "id": "src_9ab0b8fb69230ecf", "label": "DailyMed（NLM）：VYTORIN 依折麦布/辛伐他汀当前美国公开标签（2026-01-21 更新；标签正文 2024-03 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=89b860d2-de83-468e-b7e8-76aeec2edca2", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "productRoutes": [ { "source": { "id": "src_9ab0b8fb69230ecf", "label": "DailyMed（NLM）：VYTORIN 依折麦布/辛伐他汀当前美国公开标签（2026-01-21 更新；标签正文 2024-03 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=89b860d2-de83-468e-b7e8-76aeec2edca2", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-29", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_10e511bf83430e3b", "label": "FDA Orange Book 当前数据：VYTORIN，NDA 021687，四个口服片规格列为处方 RLD；10/80 mg 同时列为 RS", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-08-29", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_9ddcb06f7196a1e3", "label": "FDA Drugs@FDA 官方检索入口：VYTORIN NDA 021687 申请与标签记录", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-08-29", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-29", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "VYTORIN 一片同时含依折麦布和辛伐他汀：前一个数字固定表示依折麦布 10 mg，后一个数字表示辛伐他汀强度。它既不是单方 ZETIA，也不是单方 ZOCOR。若药单还出现这些单方药、其他他汀（如 LIPITOR、CRESTOR、LIVALO、CADUET）或相互作用药物，应带所有药盒、处方和完整药单让药师或开方团队核对，不要自行叠加、轮换、停药、掰片或按毫克换算。", "history": "FDA Orange Book 将 VYTORIN NDA 021687 的四个规格批准日期列为 2004-07-23。FDA 原始医学审评文件说明该固定复方含依折麦布 10 mg 与辛伐他汀 10、20、40 或 80 mg，并以单方资料与复方研究支持审评。当前 DailyMed 标签页面更新于 2026-01-21，标签正文修订日期为 2024-03；历史批准、现行标签和实时供应不能混写。", "sourceDocuments": [ { "id": "src_9ab0b8fb69230ecf", "label": "DailyMed（NLM）：VYTORIN 依折麦布/辛伐他汀当前美国公开标签（2026-01-21 更新；标签正文 2024-03 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=89b860d2-de83-468e-b7e8-76aeec2edca2", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, { "id": "src_10e511bf83430e3b", "label": "FDA Orange Book 当前数据：VYTORIN，NDA 021687，四个口服片规格列为处方 RLD；10/80 mg 同时列为 RS", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, { "id": "src_9ddcb06f7196a1e3", "label": "FDA Drugs@FDA 官方检索入口：VYTORIN NDA 021687 申请与标签记录", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, { "id": "src_dfce1bf241b32c66", "label": "FDA：VYTORIN NDA 021687 原始医学审评文件（2004）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/21-687_Vytorin_Medr.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_regulatory_record", "documentKind": "regulatory_review", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_pdf", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } ], "applicationNumber": "FDA NDA 021687（VYTORIN / ezetimibe and simvastatin oral tablets）", "approvalTimeline": [ { "date": "2004-07-23", "title": { "zh": "VYTORIN 四个固定复方规格获批", "en": "Four fixed VYTORIN strengths approved" }, "detail": { "zh": "FDA Orange Book 当前数据把 10/10、10/20、10/40 和 10/80 mg 的批准日期均列为 2004-07-23；原始医学审评文件说明四种固定复方的开发与审评依据。", "en": "Current FDA Orange Book data list 23 Jul 2004 as the approval date for 10/10, 10/20, 10/40 and 10/80 mg; the original medical review describes the development and review basis for the four fixed combinations." }, "source": { "id": "src_dfce1bf241b32c66", "label": "FDA：VYTORIN NDA 021687 原始医学审评文件（2004）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/21-687_Vytorin_Medr.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_regulatory_record", "documentKind": "regulatory_review", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_pdf", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } }, { "date": "2026-01-21", "title": { "zh": "当前 DailyMed 页面更新", "en": "Current DailyMed page updated" }, "detail": { "zh": "页面列四个强度、八个瓶装 NDC、四个 30 片官方展示面板、片剂外观和放大安全信息；标签正文修订日期仍为 2024-03。", "en": "The page lists four strengths, eight bottle NDCs, four official 30-tablet display panels, tablet appearances and enlarged safety information; the label revision date remains Mar 2024." }, "source": { "id": "src_9ab0b8fb69230ecf", "label": "DailyMed（NLM）：VYTORIN 依折麦布/辛伐他汀当前美国公开标签（2026-01-21 更新；标签正文 2024-03 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=89b860d2-de83-468e-b7e8-76aeec2edca2", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } }, { "date": "2026-08-28", "title": { "zh": "Orange Book 身份核验", "en": "Orange Book identity reviewed" }, "detail": { "zh": "当前数据列四个处方 RLD 规格，并将 10/80 mg 列为 RS。", "en": "Current data list four prescription RLD strengths and identify 10/80 mg as the RS." }, "source": { "id": "src_10e511bf83430e3b", "label": "FDA Orange Book 当前数据：VYTORIN，NDA 021687，四个口服片规格列为处方 RLD；10/80 mg 同时列为 RS", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "Orange Book 四个规格均为处方 RLD；10/80 mg 同时为 RS；当前 DailyMed 标签列八个瓶装 NDC", "en": "All four Orange Book strengths are prescription RLD products; 10/80 mg is also RS; current DailyMed label lists eight bottle NDCs" }, "detail": { "zh": "四个 30 片瓶装有官方展示图；四个 90 片瓶装只有标签文字身份。任何记录都不等于药房实时库存、购买资格、适合个人使用或可替代性。", "en": "Four 30-tablet bottles have official display images; four 90-tablet bottles have label-text identity only. No record establishes real-time pharmacy stock, purchasing eligibility, individual suitability or interchangeability." } }, { "market": { "zh": "中国大陆及其他市场", "en": "Mainland China and other markets" }, "status": { "zh": "待逐项建立现行市场记录", "en": "Current market record not established" }, "detail": { "zh": "不从美国品牌、共同成分或双数字推定当地批准、商品名、包装、供应或可替代性。", "en": "No local approval, trade name, pack, supply or interchangeability is inferred from the U.S. brand, shared ingredients or paired numbers." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "VYTORIN 是 ZETIA 加 ZOCOR 吗？", "en": "Is VYTORIN the same as ZETIA plus ZOCOR?" }, "answer": { "zh": "VYTORIN 一片含与这两个单方品牌相对应的依折麦布和辛伐他汀，但准确规格、标签、处方和个体安排必须逐项核对。不要自行把两盒单方替换成 VYTORIN，或在 VYTORIN 上再叠加单方。", "en": "One VYTORIN tablet contains ezetimibe and simvastatin, corresponding to the ingredients in those two single-ingredient brands, but exact strengths, labels, prescriptions and individual plans must be reviewed. Do not replace two single-ingredient packs with VYTORIN or add them to VYTORIN yourself." } }, { "question": { "zh": "为什么同一规格有 30 片和 90 片两个 NDC，却只显示一张图？", "en": "Why does one strength have 30- and 90-tablet NDCs but only one image?" }, "answer": { "zh": "当前标签为两种包装分别列出 NDC，但官方展示面板只对应 30 片瓶装。网页因此为 90 片瓶装保留文字身份卡，而不重复使用会造成误认的 30 片图片。", "en": "The current label lists separate NDCs for both packs, but the official display panel corresponds only to the 30-tablet bottle. The site therefore keeps the 90-tablet bottle as a text-only identity card rather than reusing a misleading 30-tablet image." } }, { "question": { "zh": "正在吃其他他汀，还能再吃 VYTORIN 吗？", "en": "Can VYTORIN be taken with another statin?" }, "answer": { "zh": "网页不能只凭药名回答个人联用问题。VYTORIN 本身已经含辛伐他汀；其他他汀、单方依折麦布及多种相互作用药都需要按准确药盒、处方、剂型、强度、症状和完整药单由药师或开方团队核对，不要自行叠加、轮换或停换药。", "en": "The site cannot answer an individual's combination question from medicine names alone. VYTORIN already contains simvastatin; another statin, single-ingredient ezetimibe and many interacting medicines require review of the exact packs, prescriptions, forms, strengths, symptoms and full medicine list by a pharmacist or prescribing team. Do not combine, rotate, stop or switch them yourself." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "how-to-read-a-drug-label", "dosage-forms-are-part-of-medicine-identity" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/vytorin/", "en": "https://origindrug.com/en/drugs/vytorin/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "rytary", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-29", "status": "published_traceable_archive" }, "names": { "brand": "RYTARY", "generic": "卡比多巴/左旋多巴缓释胶囊", "aliases": [ "Rytary", "carbidopa levodopa extended release", "carbidopa and levodopa extended-release capsules", "卡比多巴左旋多巴缓释胶囊", "卡比多巴/左旋多巴缓释胶囊", "carbidopa/levodopa extended release", "NDA 203312", "IPX066", "RYTARY 95", "RYTARY 145", "RYTARY 195", "RYTARY 245", "64896-661-01", "64896-661-09", "64896-661-43", "64896-661-99", "64896-662-01", "64896-662-09", "64896-662-43", "64896-662-99", "64896-663-01", "64896-663-09", "64896-663-43", "64896-663-99", "64896-664-01", "64896-664-43" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "神经与认知", "sourceArchiveMarket": "美国：DailyMed 当前 RYTARY 标签（SPL v26，2026-03-26 更新）列四个卡比多巴/左旋多巴缓释胶囊规格、十四个活跃结构化包装 NDC，并在 How Supplied 段落列四种 100 粒与四种 240 粒瓶装。官方展示面板只对应四种 100 粒、NDC -01 瓶装。FDA Orange Book 2026-08-29 数据将 NDA 203312 四个规格均列为处方 RLD，并将 61.25/245 mg 列为 RS。标签、NDC、包装图、How Supplied 与实时库存必须分层阅读。", "dosageFormClass": "卡比多巴/左旋多巴固定两成分缓释口服胶囊：23.75/95、36.25/145、48.75/195、61.25/245 mg；每组两个数字属于同一粒胶囊内两种成分；不是 SINEMET 即释片或其他缓释产品的毫克换算表", "dosageFormClassCode": "oral_modified_release", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "2015", "archiveSponsorText": "Amneal Pharmaceuticals LLC（DailyMed 当前标签）；FDA Orange Book 历史申请主体另列 Impax Laboratories LLC" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [ "SINEMET", "Sinemet CR", "STALEVO", "CREXONT", "DHIVY", "DUOPA", "VYALEV", "immediate-release carbidopa/levodopa tablet", "卡比多巴左旋多巴即释片" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-rytary-carbidopa-23-75mg-levodopa-95mg-100-capsule-bottle-ndc-6489666101", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（SPL v26，2026-03-26 更新；2026-08-29 核验）", "en": "Current U.S. DailyMed public label (SPL v26, updated 26 Mar 2026; verified 29 Aug 2026)" }, "dosageForm": { "zh": "RYTARY 卡比多巴/左旋多巴缓释口服胶囊", "en": "RYTARY carbidopa/levodopa extended-release oral capsule" }, "route": { "zh": "口服（固定两成分缓释产品身份字段）", "en": "oral (fixed two-ingredient extended-release product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 64896-661-01", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_capsule", "primaryDisplay": { "zh": "每粒卡比多巴 23.75 mg＋左旋多巴 95 mg；100 粒瓶装", "en": "Carbidopa 23.75 mg plus levodopa 95 mg per capsule; 100-capsule bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=rytary-extended-release-capsules-3.jpg&setid=6c1f7cd4-de56-45c1-a734-5e77b4aeb6f7", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "卡比多巴", "en": "carbidopa" }, "value": 23.75, "unit": "mg", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒第一成分标签量；不是个人剂量、胶囊数或与 SINEMET 的换算式", "en": "labelled amount of the first ingredient per capsule; not an individual dose, capsule count or conversion from SINEMET" } }, { "ingredient": { "zh": "左旋多巴", "en": "levodopa" }, "value": 95, "unit": "mg", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒第二成分标签量；不是个人剂量、胶囊数或与其他卡比多巴/左旋多巴制剂的换算式", "en": "labelled amount of the second ingredient per capsule; not an individual dose, capsule count or conversion from another carbidopa/levodopa product" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-29", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "current_regulatory_listing_not_inventory", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "physicalClues": { "color": { "zh": "蓝色胶囊帽、白色胶囊体", "en": "blue cap and white body" }, "shape": { "zh": "两节缓释胶囊；胶囊外形不等于可以咀嚼、分半、压碎或把一部分内容物留到以后", "en": "two-piece extended-release capsule; capsule form does not permit chewing, halving, crushing or saving part of the contents" }, "imprint": "IPX066 / 95", "scoreStatus": "capsule_not_a_split_tablet", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_062a59c4c8bbf170", "label": "DailyMed（NLM）：RYTARY 23.75/95 mg、NDC 64896-661-01、100 粒瓶装美国公开标签面板", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=6c1f7cd4-de56-45c1-a734-5e77b4aeb6f7", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-rytary-carbidopa-23-75mg-levodopa-95mg-25-capsule-bottle-ndc-6489666109", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（SPL v26，2026-03-26 更新；2026-08-29 核验）", "en": "Current U.S. DailyMed public label (SPL v26, updated 26 Mar 2026; verified 29 Aug 2026)" }, "dosageForm": { "zh": "RYTARY 卡比多巴/左旋多巴缓释口服胶囊", "en": "RYTARY carbidopa/levodopa extended-release oral capsule" }, "route": { "zh": "口服（固定两成分缓释产品身份字段）", "en": "oral (fixed two-ingredient extended-release product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 64896-661-09", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_capsule", "primaryDisplay": { "zh": "每粒卡比多巴 23.75 mg＋左旋多巴 95 mg；25 粒瓶装", "en": "Carbidopa 23.75 mg plus levodopa 95 mg per capsule; 25-capsule bottle" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "卡比多巴", "en": "carbidopa" }, "value": 23.75, "unit": "mg", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒第一成分标签量；不是个人剂量、胶囊数或与 SINEMET 的换算式", "en": "labelled amount of the first ingredient per capsule; not an individual dose, capsule count or conversion from SINEMET" } }, { "ingredient": { "zh": "左旋多巴", "en": "levodopa" }, "value": 95, "unit": "mg", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒第二成分标签量；不是个人剂量、胶囊数或与其他卡比多巴/左旋多巴制剂的换算式", "en": "labelled amount of the second ingredient per capsule; not an individual dose, capsule count or conversion from another carbidopa/levodopa product" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 25, "countUnit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-29", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "current_regulatory_listing_not_inventory", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 25, "unit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "physicalClues": { "color": { "zh": "蓝色胶囊帽、白色胶囊体", "en": "blue cap and white body" }, "shape": { "zh": "两节缓释胶囊；胶囊外形不等于可以咀嚼、分半、压碎或把一部分内容物留到以后", "en": "two-piece extended-release capsule; capsule form does not permit chewing, halving, crushing or saving part of the contents" }, "imprint": "IPX066 / 95", "scoreStatus": "capsule_not_a_split_tablet", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_062a59c4c8bbf170", "label": "DailyMed（NLM）：RYTARY 23.75/95 mg、NDC 64896-661-09、25 粒瓶装美国公开标签结构化包装文字身份", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=6c1f7cd4-de56-45c1-a734-5e77b4aeb6f7", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-rytary-carbidopa-23-75mg-levodopa-95mg-240-capsule-bottle-ndc-6489666143", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（SPL v26，2026-03-26 更新；2026-08-29 核验）", "en": "Current U.S. DailyMed public label (SPL v26, updated 26 Mar 2026; verified 29 Aug 2026)" }, "dosageForm": { "zh": "RYTARY 卡比多巴/左旋多巴缓释口服胶囊", "en": "RYTARY carbidopa/levodopa extended-release oral capsule" }, "route": { "zh": "口服（固定两成分缓释产品身份字段）", "en": "oral (fixed two-ingredient extended-release product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 64896-661-43", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_capsule", "primaryDisplay": { "zh": "每粒卡比多巴 23.75 mg＋左旋多巴 95 mg；240 粒瓶装", "en": "Carbidopa 23.75 mg plus levodopa 95 mg per capsule; 240-capsule bottle" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "卡比多巴", "en": "carbidopa" }, "value": 23.75, "unit": "mg", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒第一成分标签量；不是个人剂量、胶囊数或与 SINEMET 的换算式", "en": "labelled amount of the first ingredient per capsule; not an individual dose, capsule count or conversion from SINEMET" } }, { "ingredient": { "zh": "左旋多巴", "en": "levodopa" }, "value": 95, "unit": "mg", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒第二成分标签量；不是个人剂量、胶囊数或与其他卡比多巴/左旋多巴制剂的换算式", "en": "labelled amount of the second ingredient per capsule; not an individual dose, capsule count or conversion from another carbidopa/levodopa product" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 240, "countUnit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-29", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "current_regulatory_listing_not_inventory", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 240, "unit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "physicalClues": { "color": { "zh": "蓝色胶囊帽、白色胶囊体", "en": "blue cap and white body" }, "shape": { "zh": "两节缓释胶囊；胶囊外形不等于可以咀嚼、分半、压碎或把一部分内容物留到以后", "en": "two-piece extended-release capsule; capsule form does not permit chewing, halving, crushing or saving part of the contents" }, "imprint": "IPX066 / 95", "scoreStatus": "capsule_not_a_split_tablet", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_062a59c4c8bbf170", "label": "DailyMed（NLM）：RYTARY 23.75/95 mg、NDC 64896-661-43、240 粒瓶装美国公开标签结构化包装文字身份", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=6c1f7cd4-de56-45c1-a734-5e77b4aeb6f7", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-rytary-carbidopa-23-75mg-levodopa-95mg-100-capsule-bottle-ndc-6489666199", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（SPL v26，2026-03-26 更新；2026-08-29 核验）", "en": "Current U.S. DailyMed public label (SPL v26, updated 26 Mar 2026; verified 29 Aug 2026)" }, "dosageForm": { "zh": "RYTARY 卡比多巴/左旋多巴缓释口服胶囊", "en": "RYTARY carbidopa/levodopa extended-release oral capsule" }, "route": { "zh": "口服（固定两成分缓释产品身份字段）", "en": "oral (fixed two-ingredient extended-release product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 64896-661-99", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_capsule", "primaryDisplay": { "zh": "每粒卡比多巴 23.75 mg＋左旋多巴 95 mg；100 粒瓶装", "en": "Carbidopa 23.75 mg plus levodopa 95 mg per capsule; 100-capsule bottle" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "卡比多巴", "en": "carbidopa" }, "value": 23.75, "unit": "mg", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒第一成分标签量；不是个人剂量、胶囊数或与 SINEMET 的换算式", "en": "labelled amount of the first ingredient per capsule; not an individual dose, capsule count or conversion from SINEMET" } }, { "ingredient": { "zh": "左旋多巴", "en": "levodopa" }, "value": 95, "unit": "mg", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒第二成分标签量；不是个人剂量、胶囊数或与其他卡比多巴/左旋多巴制剂的换算式", "en": "labelled amount of the second ingredient per capsule; not an individual dose, capsule count or conversion from another carbidopa/levodopa product" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-29", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "current_regulatory_listing_not_inventory", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "physicalClues": { "color": { "zh": "蓝色胶囊帽、白色胶囊体", "en": "blue cap and white body" }, "shape": { "zh": "两节缓释胶囊；胶囊外形不等于可以咀嚼、分半、压碎或把一部分内容物留到以后", "en": "two-piece extended-release capsule; capsule form does not permit chewing, halving, crushing or saving part of the contents" }, "imprint": "IPX066 / 95", "scoreStatus": "capsule_not_a_split_tablet", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_062a59c4c8bbf170", "label": "DailyMed（NLM）：RYTARY 23.75/95 mg、NDC 64896-661-99、100 粒瓶装美国公开标签结构化包装文字身份", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=6c1f7cd4-de56-45c1-a734-5e77b4aeb6f7", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-rytary-carbidopa-36-25mg-levodopa-145mg-100-capsule-bottle-ndc-6489666201", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（SPL v26，2026-03-26 更新；2026-08-29 核验）", "en": "Current U.S. DailyMed public label (SPL v26, updated 26 Mar 2026; verified 29 Aug 2026)" }, "dosageForm": { "zh": "RYTARY 卡比多巴/左旋多巴缓释口服胶囊", "en": "RYTARY carbidopa/levodopa extended-release oral capsule" }, "route": { "zh": "口服（固定两成分缓释产品身份字段）", "en": "oral (fixed two-ingredient extended-release product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 64896-662-01", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_capsule", "primaryDisplay": { "zh": "每粒卡比多巴 36.25 mg＋左旋多巴 145 mg；100 粒瓶装", "en": "Carbidopa 36.25 mg plus levodopa 145 mg per capsule; 100-capsule bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=rytary-extended-release-capsules-4.jpg&setid=6c1f7cd4-de56-45c1-a734-5e77b4aeb6f7", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "卡比多巴", "en": "carbidopa" }, "value": 36.25, "unit": "mg", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒第一成分标签量；不是个人剂量、胶囊数或与 SINEMET 的换算式", "en": "labelled amount of the first ingredient per capsule; not an individual dose, capsule count or conversion from SINEMET" } }, { "ingredient": { "zh": "左旋多巴", "en": "levodopa" }, "value": 145, "unit": "mg", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒第二成分标签量；不是个人剂量、胶囊数或与其他卡比多巴/左旋多巴制剂的换算式", "en": "labelled amount of the second ingredient per capsule; not an individual dose, capsule count or conversion from another carbidopa/levodopa product" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-29", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "current_regulatory_listing_not_inventory", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "physicalClues": { "color": { "zh": "蓝色胶囊帽、浅蓝色胶囊体", "en": "blue cap and light-blue body" }, "shape": { "zh": "两节缓释胶囊；胶囊外形不等于可以咀嚼、分半、压碎或把一部分内容物留到以后", "en": "two-piece extended-release capsule; capsule form does not permit chewing, halving, crushing or saving part of the contents" }, "imprint": "IPX066 / 145", "scoreStatus": "capsule_not_a_split_tablet", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_062a59c4c8bbf170", "label": "DailyMed（NLM）：RYTARY 36.25/145 mg、NDC 64896-662-01、100 粒瓶装美国公开标签面板", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=6c1f7cd4-de56-45c1-a734-5e77b4aeb6f7", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-rytary-carbidopa-36-25mg-levodopa-145mg-25-capsule-bottle-ndc-6489666209", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（SPL v26，2026-03-26 更新；2026-08-29 核验）", "en": "Current U.S. DailyMed public label (SPL v26, updated 26 Mar 2026; verified 29 Aug 2026)" }, "dosageForm": { "zh": "RYTARY 卡比多巴/左旋多巴缓释口服胶囊", "en": "RYTARY carbidopa/levodopa extended-release oral capsule" }, "route": { "zh": "口服（固定两成分缓释产品身份字段）", "en": "oral (fixed two-ingredient extended-release product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 64896-662-09", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_capsule", "primaryDisplay": { "zh": "每粒卡比多巴 36.25 mg＋左旋多巴 145 mg；25 粒瓶装", "en": "Carbidopa 36.25 mg plus levodopa 145 mg per capsule; 25-capsule bottle" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "卡比多巴", "en": "carbidopa" }, "value": 36.25, "unit": "mg", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒第一成分标签量；不是个人剂量、胶囊数或与 SINEMET 的换算式", "en": "labelled amount of the first ingredient per capsule; not an individual dose, capsule count or conversion from SINEMET" } }, { "ingredient": { "zh": "左旋多巴", "en": "levodopa" }, "value": 145, "unit": "mg", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒第二成分标签量；不是个人剂量、胶囊数或与其他卡比多巴/左旋多巴制剂的换算式", "en": "labelled amount of the second ingredient per capsule; not an individual dose, capsule count or conversion from another carbidopa/levodopa product" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 25, "countUnit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-29", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "current_regulatory_listing_not_inventory", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 25, "unit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "physicalClues": { "color": { "zh": "蓝色胶囊帽、浅蓝色胶囊体", "en": "blue cap and light-blue body" }, "shape": { "zh": "两节缓释胶囊；胶囊外形不等于可以咀嚼、分半、压碎或把一部分内容物留到以后", "en": "two-piece extended-release capsule; capsule form does not permit chewing, halving, crushing or saving part of the contents" }, "imprint": "IPX066 / 145", "scoreStatus": "capsule_not_a_split_tablet", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_062a59c4c8bbf170", "label": "DailyMed（NLM）：RYTARY 36.25/145 mg、NDC 64896-662-09、25 粒瓶装美国公开标签结构化包装文字身份", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=6c1f7cd4-de56-45c1-a734-5e77b4aeb6f7", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-rytary-carbidopa-36-25mg-levodopa-145mg-240-capsule-bottle-ndc-6489666243", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（SPL v26，2026-03-26 更新；2026-08-29 核验）", "en": "Current U.S. DailyMed public label (SPL v26, updated 26 Mar 2026; verified 29 Aug 2026)" }, "dosageForm": { "zh": "RYTARY 卡比多巴/左旋多巴缓释口服胶囊", "en": "RYTARY carbidopa/levodopa extended-release oral capsule" }, "route": { "zh": "口服（固定两成分缓释产品身份字段）", "en": "oral (fixed two-ingredient extended-release product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 64896-662-43", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_capsule", "primaryDisplay": { "zh": "每粒卡比多巴 36.25 mg＋左旋多巴 145 mg；240 粒瓶装", "en": "Carbidopa 36.25 mg plus levodopa 145 mg per capsule; 240-capsule bottle" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "卡比多巴", "en": "carbidopa" }, "value": 36.25, "unit": "mg", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒第一成分标签量；不是个人剂量、胶囊数或与 SINEMET 的换算式", "en": "labelled amount of the first ingredient per capsule; not an individual dose, capsule count or conversion from SINEMET" } }, { "ingredient": { "zh": "左旋多巴", "en": "levodopa" }, "value": 145, "unit": "mg", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒第二成分标签量；不是个人剂量、胶囊数或与其他卡比多巴/左旋多巴制剂的换算式", "en": "labelled amount of the second ingredient per capsule; not an individual dose, capsule count or conversion from another carbidopa/levodopa product" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 240, "countUnit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-29", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "current_regulatory_listing_not_inventory", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 240, "unit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "physicalClues": { "color": { "zh": "蓝色胶囊帽、浅蓝色胶囊体", "en": "blue cap and light-blue body" }, "shape": { "zh": "两节缓释胶囊；胶囊外形不等于可以咀嚼、分半、压碎或把一部分内容物留到以后", "en": "two-piece extended-release capsule; capsule form does not permit chewing, halving, crushing or saving part of the contents" }, "imprint": "IPX066 / 145", "scoreStatus": "capsule_not_a_split_tablet", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_062a59c4c8bbf170", "label": "DailyMed（NLM）：RYTARY 36.25/145 mg、NDC 64896-662-43、240 粒瓶装美国公开标签结构化包装文字身份", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=6c1f7cd4-de56-45c1-a734-5e77b4aeb6f7", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-rytary-carbidopa-36-25mg-levodopa-145mg-100-capsule-bottle-ndc-6489666299", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（SPL v26，2026-03-26 更新；2026-08-29 核验）", "en": "Current U.S. DailyMed public label (SPL v26, updated 26 Mar 2026; verified 29 Aug 2026)" }, "dosageForm": { "zh": "RYTARY 卡比多巴/左旋多巴缓释口服胶囊", "en": "RYTARY carbidopa/levodopa extended-release oral capsule" }, "route": { "zh": "口服（固定两成分缓释产品身份字段）", "en": "oral (fixed two-ingredient extended-release product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 64896-662-99", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_capsule", "primaryDisplay": { "zh": "每粒卡比多巴 36.25 mg＋左旋多巴 145 mg；100 粒瓶装", "en": "Carbidopa 36.25 mg plus levodopa 145 mg per capsule; 100-capsule bottle" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "卡比多巴", "en": "carbidopa" }, "value": 36.25, "unit": "mg", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒第一成分标签量；不是个人剂量、胶囊数或与 SINEMET 的换算式", "en": "labelled amount of the first ingredient per capsule; not an individual dose, capsule count or conversion from SINEMET" } }, { "ingredient": { "zh": "左旋多巴", "en": "levodopa" }, "value": 145, "unit": "mg", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒第二成分标签量；不是个人剂量、胶囊数或与其他卡比多巴/左旋多巴制剂的换算式", "en": "labelled amount of the second ingredient per capsule; not an individual dose, capsule count or conversion from another carbidopa/levodopa product" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-29", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "current_regulatory_listing_not_inventory", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "physicalClues": { "color": { "zh": "蓝色胶囊帽、浅蓝色胶囊体", "en": "blue cap and light-blue body" }, "shape": { "zh": "两节缓释胶囊；胶囊外形不等于可以咀嚼、分半、压碎或把一部分内容物留到以后", "en": "two-piece extended-release capsule; capsule form does not permit chewing, halving, crushing or saving part of the contents" }, "imprint": "IPX066 / 145", "scoreStatus": "capsule_not_a_split_tablet", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_062a59c4c8bbf170", "label": "DailyMed（NLM）：RYTARY 36.25/145 mg、NDC 64896-662-99、100 粒瓶装美国公开标签结构化包装文字身份", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=6c1f7cd4-de56-45c1-a734-5e77b4aeb6f7", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-rytary-carbidopa-48-75mg-levodopa-195mg-100-capsule-bottle-ndc-6489666301", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（SPL v26，2026-03-26 更新；2026-08-29 核验）", "en": "Current U.S. DailyMed public label (SPL v26, updated 26 Mar 2026; verified 29 Aug 2026)" }, "dosageForm": { "zh": "RYTARY 卡比多巴/左旋多巴缓释口服胶囊", "en": "RYTARY carbidopa/levodopa extended-release oral capsule" }, "route": { "zh": "口服（固定两成分缓释产品身份字段）", "en": "oral (fixed two-ingredient extended-release product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 64896-663-01", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_capsule", "primaryDisplay": { "zh": "每粒卡比多巴 48.75 mg＋左旋多巴 195 mg；100 粒瓶装", "en": "Carbidopa 48.75 mg plus levodopa 195 mg per capsule; 100-capsule bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=rytary-extended-release-capsules-5.jpg&setid=6c1f7cd4-de56-45c1-a734-5e77b4aeb6f7", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "卡比多巴", "en": "carbidopa" }, "value": 48.75, "unit": "mg", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒第一成分标签量；不是个人剂量、胶囊数或与 SINEMET 的换算式", "en": "labelled amount of the first ingredient per capsule; not an individual dose, capsule count or conversion from SINEMET" } }, { "ingredient": { "zh": "左旋多巴", "en": "levodopa" }, "value": 195, "unit": "mg", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒第二成分标签量；不是个人剂量、胶囊数或与其他卡比多巴/左旋多巴制剂的换算式", "en": "labelled amount of the second ingredient per capsule; not an individual dose, capsule count or conversion from another carbidopa/levodopa product" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-29", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "current_regulatory_listing_not_inventory", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "physicalClues": { "color": { "zh": "蓝色胶囊帽、黄色胶囊体", "en": "blue cap and yellow body" }, "shape": { "zh": "两节缓释胶囊；胶囊外形不等于可以咀嚼、分半、压碎或把一部分内容物留到以后", "en": "two-piece extended-release capsule; capsule form does not permit chewing, halving, crushing or saving part of the contents" }, "imprint": "IPX066 / 195", "scoreStatus": "capsule_not_a_split_tablet", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_062a59c4c8bbf170", "label": "DailyMed（NLM）：RYTARY 48.75/195 mg、NDC 64896-663-01、100 粒瓶装美国公开标签面板", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=6c1f7cd4-de56-45c1-a734-5e77b4aeb6f7", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-rytary-carbidopa-48-75mg-levodopa-195mg-25-capsule-bottle-ndc-6489666309", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（SPL v26，2026-03-26 更新；2026-08-29 核验）", "en": "Current U.S. DailyMed public label (SPL v26, updated 26 Mar 2026; verified 29 Aug 2026)" }, "dosageForm": { "zh": "RYTARY 卡比多巴/左旋多巴缓释口服胶囊", "en": "RYTARY carbidopa/levodopa extended-release oral capsule" }, "route": { "zh": "口服（固定两成分缓释产品身份字段）", "en": "oral (fixed two-ingredient extended-release product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 64896-663-09", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_capsule", "primaryDisplay": { "zh": "每粒卡比多巴 48.75 mg＋左旋多巴 195 mg；25 粒瓶装", "en": "Carbidopa 48.75 mg plus levodopa 195 mg per capsule; 25-capsule bottle" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "卡比多巴", "en": "carbidopa" }, "value": 48.75, "unit": "mg", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒第一成分标签量；不是个人剂量、胶囊数或与 SINEMET 的换算式", "en": "labelled amount of the first ingredient per capsule; not an individual dose, capsule count or conversion from SINEMET" } }, { "ingredient": { "zh": "左旋多巴", "en": "levodopa" }, "value": 195, "unit": "mg", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒第二成分标签量；不是个人剂量、胶囊数或与其他卡比多巴/左旋多巴制剂的换算式", "en": "labelled amount of the second ingredient per capsule; not an individual dose, capsule count or conversion from another carbidopa/levodopa product" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 25, "countUnit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-29", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "current_regulatory_listing_not_inventory", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 25, "unit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "physicalClues": { "color": { "zh": "蓝色胶囊帽、黄色胶囊体", "en": "blue cap and yellow body" }, "shape": { "zh": "两节缓释胶囊；胶囊外形不等于可以咀嚼、分半、压碎或把一部分内容物留到以后", "en": "two-piece extended-release capsule; capsule form does not permit chewing, halving, crushing or saving part of the contents" }, "imprint": "IPX066 / 195", "scoreStatus": "capsule_not_a_split_tablet", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_062a59c4c8bbf170", "label": "DailyMed（NLM）：RYTARY 48.75/195 mg、NDC 64896-663-09、25 粒瓶装美国公开标签结构化包装文字身份", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=6c1f7cd4-de56-45c1-a734-5e77b4aeb6f7", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-rytary-carbidopa-48-75mg-levodopa-195mg-240-capsule-bottle-ndc-6489666343", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（SPL v26，2026-03-26 更新；2026-08-29 核验）", "en": "Current U.S. DailyMed public label (SPL v26, updated 26 Mar 2026; verified 29 Aug 2026)" }, "dosageForm": { "zh": "RYTARY 卡比多巴/左旋多巴缓释口服胶囊", "en": "RYTARY carbidopa/levodopa extended-release oral capsule" }, "route": { "zh": "口服（固定两成分缓释产品身份字段）", "en": "oral (fixed two-ingredient extended-release product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 64896-663-43", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_capsule", "primaryDisplay": { "zh": "每粒卡比多巴 48.75 mg＋左旋多巴 195 mg；240 粒瓶装", "en": "Carbidopa 48.75 mg plus levodopa 195 mg per capsule; 240-capsule bottle" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "卡比多巴", "en": "carbidopa" }, "value": 48.75, "unit": "mg", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒第一成分标签量；不是个人剂量、胶囊数或与 SINEMET 的换算式", "en": "labelled amount of the first ingredient per capsule; not an individual dose, capsule count or conversion from SINEMET" } }, { "ingredient": { "zh": "左旋多巴", "en": "levodopa" }, "value": 195, "unit": "mg", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒第二成分标签量；不是个人剂量、胶囊数或与其他卡比多巴/左旋多巴制剂的换算式", "en": "labelled amount of the second ingredient per capsule; not an individual dose, capsule count or conversion from another carbidopa/levodopa product" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 240, "countUnit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-29", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "current_regulatory_listing_not_inventory", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 240, "unit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "physicalClues": { "color": { "zh": "蓝色胶囊帽、黄色胶囊体", "en": "blue cap and yellow body" }, "shape": { "zh": "两节缓释胶囊；胶囊外形不等于可以咀嚼、分半、压碎或把一部分内容物留到以后", "en": "two-piece extended-release capsule; capsule form does not permit chewing, halving, crushing or saving part of the contents" }, "imprint": "IPX066 / 195", "scoreStatus": "capsule_not_a_split_tablet", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_062a59c4c8bbf170", "label": "DailyMed（NLM）：RYTARY 48.75/195 mg、NDC 64896-663-43、240 粒瓶装美国公开标签结构化包装文字身份", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=6c1f7cd4-de56-45c1-a734-5e77b4aeb6f7", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-rytary-carbidopa-48-75mg-levodopa-195mg-100-capsule-bottle-ndc-6489666399", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（SPL v26，2026-03-26 更新；2026-08-29 核验）", "en": "Current U.S. DailyMed public label (SPL v26, updated 26 Mar 2026; verified 29 Aug 2026)" }, "dosageForm": { "zh": "RYTARY 卡比多巴/左旋多巴缓释口服胶囊", "en": "RYTARY carbidopa/levodopa extended-release oral capsule" }, "route": { "zh": "口服（固定两成分缓释产品身份字段）", "en": "oral (fixed two-ingredient extended-release product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 64896-663-99", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_capsule", "primaryDisplay": { "zh": "每粒卡比多巴 48.75 mg＋左旋多巴 195 mg；100 粒瓶装", "en": "Carbidopa 48.75 mg plus levodopa 195 mg per capsule; 100-capsule bottle" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "卡比多巴", "en": "carbidopa" }, "value": 48.75, "unit": "mg", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒第一成分标签量；不是个人剂量、胶囊数或与 SINEMET 的换算式", "en": "labelled amount of the first ingredient per capsule; not an individual dose, capsule count or conversion from SINEMET" } }, { "ingredient": { "zh": "左旋多巴", "en": "levodopa" }, "value": 195, "unit": "mg", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒第二成分标签量；不是个人剂量、胶囊数或与其他卡比多巴/左旋多巴制剂的换算式", "en": "labelled amount of the second ingredient per capsule; not an individual dose, capsule count or conversion from another carbidopa/levodopa product" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-29", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "current_regulatory_listing_not_inventory", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "physicalClues": { "color": { "zh": "蓝色胶囊帽、黄色胶囊体", "en": "blue cap and yellow body" }, "shape": { "zh": "两节缓释胶囊；胶囊外形不等于可以咀嚼、分半、压碎或把一部分内容物留到以后", "en": "two-piece extended-release capsule; capsule form does not permit chewing, halving, crushing or saving part of the contents" }, "imprint": "IPX066 / 195", "scoreStatus": "capsule_not_a_split_tablet", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_062a59c4c8bbf170", "label": "DailyMed（NLM）：RYTARY 48.75/195 mg、NDC 64896-663-99、100 粒瓶装美国公开标签结构化包装文字身份", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=6c1f7cd4-de56-45c1-a734-5e77b4aeb6f7", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-rytary-carbidopa-61-25mg-levodopa-245mg-100-capsule-bottle-ndc-6489666401", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（SPL v26，2026-03-26 更新；2026-08-29 核验）", "en": "Current U.S. DailyMed public label (SPL v26, updated 26 Mar 2026; verified 29 Aug 2026)" }, "dosageForm": { "zh": "RYTARY 卡比多巴/左旋多巴缓释口服胶囊", "en": "RYTARY carbidopa/levodopa extended-release oral capsule" }, "route": { "zh": "口服（固定两成分缓释产品身份字段）", "en": "oral (fixed two-ingredient extended-release product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 64896-664-01", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_capsule", "primaryDisplay": { "zh": "每粒卡比多巴 61.25 mg＋左旋多巴 245 mg；100 粒瓶装", "en": "Carbidopa 61.25 mg plus levodopa 245 mg per capsule; 100-capsule bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=rytary-extended-release-capsules-6.jpg&setid=6c1f7cd4-de56-45c1-a734-5e77b4aeb6f7", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "卡比多巴", "en": "carbidopa" }, "value": 61.25, "unit": "mg", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒第一成分标签量；不是个人剂量、胶囊数或与 SINEMET 的换算式", "en": "labelled amount of the first ingredient per capsule; not an individual dose, capsule count or conversion from SINEMET" } }, { "ingredient": { "zh": "左旋多巴", "en": "levodopa" }, "value": 245, "unit": "mg", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒第二成分标签量；不是个人剂量、胶囊数或与其他卡比多巴/左旋多巴制剂的换算式", "en": "labelled amount of the second ingredient per capsule; not an individual dose, capsule count or conversion from another carbidopa/levodopa product" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-29", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "current_regulatory_listing_not_inventory", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "physicalClues": { "color": { "zh": "蓝色胶囊帽、蓝色胶囊体", "en": "blue cap and blue body" }, "shape": { "zh": "两节缓释胶囊；胶囊外形不等于可以咀嚼、分半、压碎或把一部分内容物留到以后", "en": "two-piece extended-release capsule; capsule form does not permit chewing, halving, crushing or saving part of the contents" }, "imprint": "IPX066 / 245", "scoreStatus": "capsule_not_a_split_tablet", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_062a59c4c8bbf170", "label": "DailyMed（NLM）：RYTARY 61.25/245 mg、NDC 64896-664-01、100 粒瓶装美国公开标签面板", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=6c1f7cd4-de56-45c1-a734-5e77b4aeb6f7", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-rytary-carbidopa-61-25mg-levodopa-245mg-240-capsule-bottle-ndc-6489666443", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（SPL v26，2026-03-26 更新；2026-08-29 核验）", "en": "Current U.S. DailyMed public label (SPL v26, updated 26 Mar 2026; verified 29 Aug 2026)" }, "dosageForm": { "zh": "RYTARY 卡比多巴/左旋多巴缓释口服胶囊", "en": "RYTARY carbidopa/levodopa extended-release oral capsule" }, "route": { "zh": "口服（固定两成分缓释产品身份字段）", "en": "oral (fixed two-ingredient extended-release product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 64896-664-43", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_capsule", "primaryDisplay": { "zh": "每粒卡比多巴 61.25 mg＋左旋多巴 245 mg；240 粒瓶装", "en": "Carbidopa 61.25 mg plus levodopa 245 mg per capsule; 240-capsule bottle" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "卡比多巴", "en": "carbidopa" }, "value": 61.25, "unit": "mg", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒第一成分标签量；不是个人剂量、胶囊数或与 SINEMET 的换算式", "en": "labelled amount of the first ingredient per capsule; not an individual dose, capsule count or conversion from SINEMET" } }, { "ingredient": { "zh": "左旋多巴", "en": "levodopa" }, "value": 245, "unit": "mg", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒第二成分标签量；不是个人剂量、胶囊数或与其他卡比多巴/左旋多巴制剂的换算式", "en": "labelled amount of the second ingredient per capsule; not an individual dose, capsule count or conversion from another carbidopa/levodopa product" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 240, "countUnit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-29", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "current_regulatory_listing_not_inventory", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 240, "unit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "physicalClues": { "color": { "zh": "蓝色胶囊帽、蓝色胶囊体", "en": "blue cap and blue body" }, "shape": { "zh": "两节缓释胶囊；胶囊外形不等于可以咀嚼、分半、压碎或把一部分内容物留到以后", "en": "two-piece extended-release capsule; capsule form does not permit chewing, halving, crushing or saving part of the contents" }, "imprint": "IPX066 / 245", "scoreStatus": "capsule_not_a_split_tablet", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_062a59c4c8bbf170", "label": "DailyMed（NLM）：RYTARY 61.25/245 mg、NDC 64896-664-43、240 粒瓶装美国公开标签结构化包装文字身份", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=6c1f7cd4-de56-45c1-a734-5e77b4aeb6f7", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-rytary-carbidopa-23-75mg-levodopa-95mg-100-capsule-bottle-ndc-6489666101", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=rytary-extended-release-capsules-3.jpg&setid=6c1f7cd4-de56-45c1-a734-5e77b4aeb6f7", "alt": "DailyMed 当前 RYTARY 23.75/95 mg、NDC 64896-661-01、100 粒瓶装标签面板", "archiveMarket": "美国", "labelVersion": "DailyMed 美国当前公开标签（SPL v26，2026-03-26 更新）", "presentation": "RYTARY 每粒卡比多巴 23.75 mg / 左旋多巴 95 mg，NDC 64896-661-01，100 粒瓶装。", "notice": "此图只对应 RYTARY 23.75/95 mg、NDC 64896-661-01、100 粒瓶装；不能代表另三个 100 粒包装、240 粒或 25 粒包装、另一个 100 粒 NDC、其他卡比多巴/左旋多巴制剂、其他市场或仿制药，不用于鉴定真伪，也不证明实时库存或可替代性。", "source": { "id": "src_062a59c4c8bbf170", "label": "DailyMed（NLM）：RYTARY 23.75/95 mg、NDC 64896-661-01、100 粒瓶装美国公开标签面板", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=6c1f7cd4-de56-45c1-a734-5e77b4aeb6f7", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } }, "visualCoverageNote": { "status": "partial_exact_visual_coverage", "title": { "zh": "十四个包装身份中只有四个有精确官方展示面板", "en": "Only four of fourteen package identities have exact official display panels" }, "summary": { "zh": "当前 SPL 为四种 100 粒、NDC -01 瓶装提供准确展示面板；其余十个活跃结构化包装 NDC 只有来源文字身份。网页为这些包装保留文字卡，不借用相同规格或相同片数的图片。", "en": "The current SPL provides exact display panels for the four 100-capsule NDC -01 bottles. The other ten active structured package NDCs have source-text identity only. The site keeps text cards for them and does not borrow an image from the same strength or pack count." }, "source": { "id": "src_062a59c4c8bbf170", "label": "DailyMed（NLM）：RYTARY 卡比多巴/左旋多巴缓释胶囊当前美国公开标签（SPL v26，2026-03-26 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=6c1f7cd4-de56-45c1-a734-5e77b4aeb6f7", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } }, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "RYTARY 说明书放大阅读：缓释胶囊不能分半；吞咽困难时必须使用全部内容物", "en": "RYTARY label reading: the extended-release capsule cannot be halved; swallowing difficulty requires the entire contents" }, "summary": { "zh": "四组双数字都是每粒胶囊内卡比多巴和左旋多巴的标示量。打开胶囊撒在苹果酱上，是现行标签针对吞咽困难给出的整粒内容物给药方式，不是减半、按颗粒估算剂量或改变缓释结构的通用许可。RYTARY 与 SINEMET、STALEVO、CREXONT 等产品不能按共同成分或毫克数自行换算。", "en": "Each paired strength states carbidopa and levodopa in one capsule. Opening the capsule onto applesauce is a current-label administration option for swallowing difficulty using the entire contents; it is not permission to halve a dose, estimate pellets or alter extended release generally. RYTARY cannot be self-converted with SINEMET, STALEVO, CREXONT or another product from shared ingredients or milligrams." }, "checks": [ { "zh": "标签要求整粒吞服；不要咀嚼、分开当两次、压碎或把颗粒研碎。吞咽困难时，可按标签小心旋开胶囊两半，把两半的全部内容物撒在 1–2 汤匙苹果酱上立即全部吃完；不能保存，也不能只取一半。若实际产品、食物要求或吞咽能力不同，应让药师或开方团队核对。", "en": "The label says to swallow the capsule whole and not chew, divide or crush it or grind the pellets. For swallowing difficulty, the label allows carefully opening both halves, sprinkling the entire contents on 1–2 tablespoons of applesauce and consuming it immediately. Do not store it or take only part. Have a pharmacist or prescriber review a different actual product, food requirement or swallowing limitation." }, { "zh": "RYTARY 与其他卡比多巴/左旋多巴产品不可互换。SINEMET 是即释片；STALEVO 还含恩他卡朋；CREXONT、DHIVY、DUOPA、VYALEV 等还有不同剂型或给药系统。不要根据总左旋多巴毫克、双数字、外观或旧处方自行叠加、隔天轮换、换算或替换。", "en": "RYTARY is not interchangeable with other carbidopa/levodopa products. SINEMET is an immediate-release tablet; STALEVO also contains entacapone; CREXONT, DHIVY, DUOPA and VYALEV have different forms or delivery systems. Do not self-combine, alternate by day, convert or substitute from total levodopa milligrams, paired numbers, appearance or an old prescription." }, { "zh": "不要突然停用或快速减量。标签描述快速减量、停药或改变多巴胺能治疗后可能出现高热、肌肉僵硬、意识改变和自主神经不稳定。若出现高热、明显僵硬、意识异常、呼吸或循环不稳等急性严重表现，立即使用当地急救服务，并携带药盒与完整药单。", "en": "Do not suddenly stop or rapidly reduce RYTARY. The label describes hyperpyrexia, muscular rigidity, altered consciousness and autonomic instability after rapid reduction, withdrawal or changes in dopaminergic therapy. Use local emergency services immediately for high fever, marked rigidity, altered consciousness, breathing or circulatory instability, and take the pack and complete medicine list." }, { "zh": "日常活动中突然入睡、明显嗜睡或头晕可能影响驾驶和操作机器；幻觉、精神症状、异常冲动（赌博、消费、性冲动、暴食等）或新的不自主动作也需要尽快联系治疗团队。家属和照护者常比本人更早注意到这些变化。网页不据此替个人调药。", "en": "Sudden sleep during daily activities, marked somnolence or dizziness may impair driving or machinery use. Hallucinations, psychotic symptoms, intense urges involving gambling, spending, sex or eating, and new involuntary movements also require prompt contact with the care team. Family or carers may notice these changes first. The site does not adjust treatment from these symptoms." }, { "zh": "2026 年标签加入维生素 B6 缺乏与相关癫痫发作警告。抑郁、意识混乱、口角炎、舌炎、皮炎、贫血、神经病变或癫痫发作需要医疗评估；癫痫发作、意识丧失或持续抽搐时立即使用当地急救服务。不要依据网页自行检测、补充大剂量 B6 或停换药。", "en": "The 2026 label added a warning about vitamin B6 deficiency and associated seizures. Depression, confusion, cheilosis, glossitis, dermatitis, anaemia, neuropathy or seizures needs clinical assessment; use local emergency services for a seizure, loss of consciousness or ongoing convulsions. Do not use the site to arrange testing, high-dose B6 supplementation, stopping or switching." }, { "zh": "非选择性 MAO 抑制剂（如苯乙肼、反苯环丙胺）及停药不足两周属于标签禁忌边界。铁盐或含铁复合维生素可能降低生物利用度；高脂高热量餐可能延迟吸收，高蛋白餐也可能影响左旋多巴吸收。不要自行停药、改餐、错开时间或删掉补充剂，让药师按完整药单和日常饮食核对。", "en": "Nonselective MAO inhibitors such as phenelzine or tranylcypromine, including use within the past two weeks, form a labelled contraindication boundary. Iron salts or iron-containing multivitamins may reduce bioavailability; high-fat, high-calorie meals may delay absorption, and high-protein meals may also affect levodopa absorption. Do not self-stop medicines, change meals, schedule separation or remove supplements; have a pharmacist review the full list and usual diet." }, { "zh": "标签还提醒心血管缺血事件、既往消化性溃疡出血风险和青光眼眼压监测。胸痛、严重气促、昏厥、呕血或黑便、急性视力变化等严重表现应使用当地紧急医疗渠道；网页不根据症状替个人继续、暂停或改变规格。", "en": "The label also addresses cardiovascular ischaemic events, upper gastrointestinal bleeding risk with prior peptic ulcer and intraocular-pressure monitoring in glaucoma. Use local urgent or emergency care for chest pain, severe breathlessness, fainting, vomiting blood or black stools, acute visual change or another serious presentation; the site does not continue, pause or change a strength for an individual." } ], "source": { "id": "src_062a59c4c8bbf170", "label": "DailyMed（NLM）：RYTARY 卡比多巴/左旋多巴缓释胶囊当前美国公开标签（SPL v26，2026-03-26 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=6c1f7cd4-de56-45c1-a734-5e77b4aeb6f7", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "两种成分怎样配合：左旋多巴进入脑内形成多巴胺，卡比多巴主要减少外周分解", "en": "How the two ingredients work together: levodopa reaches the brain to form dopamine while carbidopa mainly reduces peripheral breakdown" }, "summary": { "zh": "当前标签说明，左旋多巴可通过血脑屏障并在脑内转化为多巴胺；卡比多巴不易通过血脑屏障，主要抑制外周左旋多巴脱羧，使更多左旋多巴可供进入脑内。RYTARY 还通过即释与缓释成分组合形成特定释放曲线。机制能解释为什么同一粒有两种成分和缓释设计，但不能产生个人转换表、适合性或胶囊数。", "en": "The current label explains that levodopa crosses the blood-brain barrier and is converted to dopamine in the brain, while carbidopa does not readily cross and mainly inhibits peripheral levodopa decarboxylation, leaving more levodopa available to reach the brain. RYTARY also combines immediate- and extended-release components for a specific release profile. This explains two ingredients and the extended-release design but cannot produce an individual conversion table, suitability decision or capsule count." }, "checks": [ { "zh": "同一通用成分不等于相同释放曲线。RYTARY、SINEMET、Sinemet CR 与 CREXONT 的剂型结构不同，不能把每粒或每片 mg 直接相加后认定等效。", "en": "Shared generic ingredients do not create the same release profile. RYTARY, SINEMET, Sinemet CR and CREXONT have different dosage-form designs; per-capsule or per-tablet milligrams cannot simply be added and treated as equivalent." }, { "zh": "打开胶囊把全部颗粒撒在苹果酱上，不等于破坏缓释颗粒；咀嚼、压碎、研磨、只取部分或存放混合物会越过标签边界。", "en": "Opening the capsule and sprinkling all pellets on applesauce does not mean destroying the extended-release pellets. Chewing, crushing, grinding, taking only part or storing the mixture crosses the label boundary." }, { "zh": "作用机理不会判断某个人何时出现“开”“关”、是否需要换制剂、如何处理漏服或是否适合基因筛查。帕金森病治疗和多药联用应由熟悉病情的团队结合实际产品、症状日记和完整药单评估。", "en": "Mechanism cannot determine an individual's on/off timing, need for a formulation change, missed-use response or suitability for genetic screening. Parkinson treatment and polypharmacy require the treating team to review the actual product, symptom record and complete medicine list." } ], "source": { "id": "src_062a59c4c8bbf170", "label": "DailyMed（NLM）：RYTARY 卡比多巴/左旋多巴缓释胶囊当前美国公开标签（SPL v26，2026-03-26 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=6c1f7cd4-de56-45c1-a734-5e77b4aeb6f7", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "RYTARY", "generic": "卡比多巴/左旋多巴缓释胶囊", "dosageFormClass": "卡比多巴/左旋多巴固定两成分缓释口服胶囊：23.75/95、36.25/145、48.75/195、61.25/245 mg；每组两个数字属于同一粒胶囊内两种成分；不是 SINEMET 即释片或其他缓释产品的毫克换算表" }, "labelSource": { "id": "src_062a59c4c8bbf170", "label": "DailyMed（NLM）：RYTARY 卡比多巴/左旋多巴缓释胶囊当前美国公开标签（SPL v26，2026-03-26 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=6c1f7cd4-de56-45c1-a734-5e77b4aeb6f7", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "productRoutes": [ { "source": { "id": "src_062a59c4c8bbf170", "label": "DailyMed（NLM）：RYTARY 卡比多巴/左旋多巴缓释胶囊当前美国公开标签（SPL v26，2026-03-26 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=6c1f7cd4-de56-45c1-a734-5e77b4aeb6f7", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-29", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_10e511bf83430e3b", "label": "FDA Orange Book 当前数据：RYTARY，NDA 203312，四个缓释胶囊规格均列为处方 RLD；61.25/245 mg 同时为 RS", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-08-29", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_9ddcb06f7196a1e3", "label": "FDA Drugs@FDA 官方检索入口：RYTARY NDA 203312 申请、标签与补充申请记录", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-08-29", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-29", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [ { "id": "fda-2026-rytary-carbidopa-levodopa-vitamin-b6-seizure-safety-communication", "issuedAt": "2026-03-20", "status": "fda_drug_safety_communication", "title": { "zh": "FDA 药物安全通讯：RYTARY 等含卡比多巴/左旋多巴产品的维生素 B6 缺乏与癫痫发作警告", "en": "FDA Drug Safety Communication: vitamin B6 deficiency and seizures warning for RYTARY and other carbidopa/levodopa products" }, "summary": { "zh": "FDA 于 2026-03-20 发布安全通讯，要求所有含卡比多巴/左旋多巴产品加入维生素 B6 缺乏及相关癫痫发作警告；RYTARY 当前标签已经纳入这项警示。该通讯不能判断个人是否缺乏维生素 B6、是否需要检测或补充，也不能支持自行停药、换成 SINEMET／STALEVO、改变胶囊数或调整给药时间。出现癫痫发作、意识丧失或持续抽搐时使用当地急救服务；其他疑似表现请让开方团队结合准确产品和完整药单评估。", "en": "On 20 Mar 2026, FDA issued a Drug Safety Communication requiring every carbidopa/levodopa product to add a warning about vitamin B6 deficiency and associated seizures; the current RYTARY label includes this warning. The communication cannot determine an individual's vitamin B6 status, need for testing or supplementation, and does not support self-stopping, switching to SINEMET or STALEVO, changing capsule counts or altering timing. Use local emergency services for a seizure, loss of consciousness or ongoing convulsions; have the prescribing team assess other suspected symptoms using the exact product and complete medicine list." }, "source": { "id": "src_8e24316f2d733113", "label": "FDA：2026-03-20 含卡比多巴/左旋多巴产品维生素 B6 缺乏与癫痫发作药物安全通讯", "url": "https://www.fda.gov/drugs/drug-safety-communications/fda-requiring-warning-about-vitamin-b6-deficiency-and-associated-seizures-drug-products-containing", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "RYTARY 是卡比多巴/左旋多巴缓释胶囊，不是 SINEMET 即释片的另一种包装。标签明确说 RYTARY 与其他卡比多巴/左旋多巴产品的剂量不可互换。整粒能吞咽时应整粒吞服；吞咽困难者，标签允许把胶囊两半全部内容物撒在少量苹果酱上立即吃完，但不能咀嚼、分成半粒、压碎、只吃一部分或留到以后。网页只解释产品和说明书，不计算个人胶囊数、转换表、间隔、漏服或停药方案。", "history": "FDA 于 2015-01-07 批准 RYTARY NDA 203312 的四个缓释胶囊规格；当前 Orange Book 仍将四个规格列为处方 RLD。2026 年补充申请及 FDA 安全通讯把维生素 B6 缺乏与相关癫痫发作信息纳入含卡比多巴/左旋多巴产品的标签更新。DailyMed 当前页面于 2026-03-26 更新。标签所写 Initial U.S. Approval: 1975 指卡比多巴/左旋多巴组合的历史，不是 RYTARY 品牌在 1975 年获批。", "sourceDocuments": [ { "id": "src_062a59c4c8bbf170", "label": "DailyMed（NLM）：RYTARY 卡比多巴/左旋多巴缓释胶囊当前美国公开标签（SPL v26，2026-03-26 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=6c1f7cd4-de56-45c1-a734-5e77b4aeb6f7", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, { "id": "src_10e511bf83430e3b", "label": "FDA Orange Book 当前数据：RYTARY，NDA 203312，四个缓释胶囊规格均列为处方 RLD；61.25/245 mg 同时为 RS", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, { "id": "src_9ddcb06f7196a1e3", "label": "FDA Drugs@FDA 官方检索入口：RYTARY NDA 203312 申请、标签与补充申请记录", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, { "id": "src_cbd3cd0c28d32a40", "label": "FDA：RYTARY NDA 203312 原始批准函（2015-01-07）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203312Orig1s000ltr.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_regulatory_record", "documentKind": "regulatory_review", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_pdf", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, { "id": "src_fa67960e7b1a5aba", "label": "FDA：RYTARY NDA 203312/S-026 维生素 B6 缺乏与癫痫发作标签补充批准函（2026）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/203312Orig1s026ltr.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_regulatory_record", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_pdf", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, { "id": "src_8e24316f2d733113", "label": "FDA：2026-03-20 含卡比多巴/左旋多巴产品维生素 B6 缺乏与癫痫发作药物安全通讯", "url": "https://www.fda.gov/drugs/drug-safety-communications/fda-requiring-warning-about-vitamin-b6-deficiency-and-associated-seizures-drug-products-containing", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } ], "applicationNumber": "FDA NDA 203312（RYTARY / carbidopa and levodopa extended-release capsules）", "approvalTimeline": [ { "date": "2015-01-07", "title": { "zh": "RYTARY 四个缓释胶囊规格获批", "en": "Four RYTARY extended-release capsule strengths approved" }, "detail": { "zh": "FDA 原始批准函确认 NDA 203312 的 23.75/95、36.25/145、48.75/195 与 61.25/245 mg 四个规格获批；Orange Book 当前数据仍列四个处方 RLD。", "en": "The FDA original approval letter confirms approval of NDA 203312 strengths 23.75/95, 36.25/145, 48.75/195 and 61.25/245 mg; current Orange Book data still list four prescription RLD products." }, "source": { "id": "src_cbd3cd0c28d32a40", "label": "FDA：RYTARY NDA 203312 原始批准函（2015-01-07）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203312Orig1s000ltr.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_regulatory_record", "documentKind": "regulatory_review", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_pdf", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } }, { "date": "2026-03-20", "title": { "zh": "FDA 发布维生素 B6 缺乏与癫痫发作安全通讯", "en": "FDA issued vitamin B6 deficiency and seizure safety communication" }, "detail": { "zh": "该通讯覆盖含卡比多巴/左旋多巴产品，并要求相应标签更新；它不判断任何个人是否缺乏、是否需要补充或是否应停药。", "en": "The communication covers carbidopa/levodopa products and requires corresponding label updates; it does not determine an individual's deficiency, supplementation need or whether treatment should be stopped." }, "source": { "id": "src_8e24316f2d733113", "label": "FDA：2026-03-20 含卡比多巴/左旋多巴产品维生素 B6 缺乏与癫痫发作药物安全通讯", "url": "https://www.fda.gov/drugs/drug-safety-communications/fda-requiring-warning-about-vitamin-b6-deficiency-and-associated-seizures-drug-products-containing", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "date": "2026-03-26", "title": { "zh": "当前 DailyMed 页面更新", "en": "Current DailyMed page updated" }, "detail": { "zh": "SPL v26 列四个规格、十四个活跃结构化包装 NDC、四个精确 100 粒瓶装面板、胶囊打开/苹果酱规则和扩展安全信息。", "en": "SPL v26 lists four strengths, fourteen active structured package NDCs, four exact 100-capsule bottle panels, capsule-opening/applesauce instructions and expanded safety information." }, "source": { "id": "src_062a59c4c8bbf170", "label": "DailyMed（NLM）：RYTARY 卡比多巴/左旋多巴缓释胶囊当前美国公开标签（SPL v26，2026-03-26 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=6c1f7cd4-de56-45c1-a734-5e77b4aeb6f7", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } }, { "date": "2026-08-29", "title": { "zh": "Orange Book 身份核验", "en": "Orange Book identity reviewed" }, "detail": { "zh": "当前数据列四个处方 RLD 规格，并将 61.25/245 mg 列为 RS。", "en": "Current data list four prescription RLD strengths and identify 61.25/245 mg as the RS." }, "source": { "id": "src_10e511bf83430e3b", "label": "FDA Orange Book 当前数据：RYTARY，NDA 203312，四个缓释胶囊规格均列为处方 RLD；61.25/245 mg 同时为 RS", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "四个处方 RLD；61.25/245 mg 同时为 RS；当前 SPL 列十四个活跃包装 NDC", "en": "Four prescription RLD products; 61.25/245 mg is also RS; current SPL lists fourteen active package NDCs" }, "detail": { "zh": "四种 100 粒、NDC -01 瓶装有精确展示面板；其余包装保持文字身份。任何记录都不等于药房实时库存、购买资格、个人适用性或与其他卡比多巴/左旋多巴产品可互换。", "en": "Four 100-capsule NDC -01 bottles have exact display panels; the remaining packs retain text identity. No record establishes real-time stock, purchasing eligibility, individual suitability or interchangeability with another carbidopa/levodopa product." } }, { "market": { "zh": "中国大陆及其他市场", "en": "Mainland China and other markets" }, "status": { "zh": "待逐项建立现行市场记录", "en": "Current market record not established" }, "detail": { "zh": "不从美国品牌、共同成分、颜色或双数字推定当地批准、商品名、包装、供应或可替代性。", "en": "No local approval, trade name, pack, supply or interchangeability is inferred from the U.S. brand, shared ingredients, colours or paired numbers." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "RYTARY 胶囊可以打开吃一半吗？", "en": "Can a RYTARY capsule be opened and half taken?" }, "answer": { "zh": "不能。现行标签针对吞咽困难允许打开胶囊，但必须把两半的全部内容物撒在少量苹果酱上立即全部吃完；不能分半、估算颗粒、压碎、咀嚼或留到以后。任何个人调整必须由开方团队决定。", "en": "No. The current label allows opening for swallowing difficulty only when the entire contents of both halves are sprinkled on a small amount of applesauce and consumed immediately. Do not halve, estimate pellets, crush, chew or save them. Any individual adjustment belongs with the prescribing team." } }, { "question": { "zh": "RYTARY 和 SINEMET 的毫克数能直接换算吗？", "en": "Can RYTARY and SINEMET milligrams be converted directly?" }, "answer": { "zh": "不能。标签明确说明 RYTARY 与其他卡比多巴/左旋多巴产品不可互换；两者的释放结构和处方转换规则不同。网页不提供个人转换表，应把两盒药、处方时间表和症状记录交给治疗团队核对。", "en": "No. The label states that RYTARY is not interchangeable with other carbidopa/levodopa products; release design and prescribed conversion rules differ. The site provides no individual conversion table. Take both packs, prescribed schedule and symptom record to the treating team." } }, { "question": { "zh": "为什么同一规格会出现多个瓶装 NDC，却只有一张图？", "en": "Why can one strength have several bottle NDCs but only one image?" }, "answer": { "zh": "当前 SPL 的结构化包装数据列多个活跃 NDC，但官方展示面板只对应四个 100 粒、NDC -01 瓶装。网页因此为其他 NDC 保留文字身份卡，不重复使用可能造成误认的图片。", "en": "The current SPL structured package data list several active NDCs per strength, while official display panels correspond only to four 100-capsule NDC -01 bottles. The site therefore keeps text-only identity cards for the other NDCs rather than reusing a potentially misleading image." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "how-to-read-a-drug-label", "dosage-forms-are-part-of-medicine-identity", "family-medicine-list-for-pharmacist" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/rytary/", "en": "https://origindrug.com/en/drugs/rytary/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "crexont", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-29", "status": "published_traceable_archive" }, "names": { "brand": "CREXONT", "generic": "卡比多巴/左旋多巴缓释胶囊", "aliases": [ "Crexont", "IPX203", "carbidopa and levodopa extended-release capsules", "carbidopa levodopa extended release", "卡比多巴左旋多巴缓释胶囊", "CREXONT 140", "CREXONT 210", "CREXONT 280", "CREXONT 350", "64896-967-16", "64896-967-23", "64896-968-16", "64896-968-23", "64896-969-16", "64896-969-23", "64896-970-16", "64896-970-23", "NDA 217186", "carbidopa/levodopa extended release", "卡比多巴/左旋多巴缓释胶囊" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "神经与认知", "sourceArchiveMarket": "美国：DailyMed 当前 CREXONT 标签（SPL v19，2026-05-29 更新）列四个规格和八个 120 粒结构化包装 NDC；How Supplied 段落列四个 -16 NDC，且仅这四个有准确官方纸盒面板。FDA Orange Book 当前数据将 NDA 217186 四规格均列为处方 RLD，并将 87.5/350 mg 列为 RS。公开监管记录不等于药房库存、购买资格、个人适用性或与其他卡比多巴/左旋多巴产品可互换。", "dosageFormClass": "卡比多巴/左旋多巴固定两成分缓释口服胶囊：35/140、52.5/210、70/280、87.5/350 mg；每组数字属于同一粒胶囊内两种成分；CREXONT 与 RYTARY、SINEMET、STALEVO 等是不同产品，不能把标签数字当成个人换算表", "dosageFormClassCode": "oral_modified_release", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "2024", "archiveSponsorText": "Amneal Pharmaceuticals LLC（DailyMed 当前标签）；FDA Orange Book 申请主体列 Impax Laboratories LLC" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [ "RYTARY", "SINEMET", "Sinemet CR", "STALEVO", "DHIVY", "DUOPA", "VYALEV", "immediate-release carbidopa/levodopa tablet", "卡比多巴左旋多巴即释片" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-crexont-carbidopa-35mg-levodopa-140mg-120-capsule-carton-ndc-6489696716", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（SPL v19，2026-05-29 更新；2026-08-29 核验）", "en": "Current U.S. DailyMed public label (SPL v19, updated 29 May 2026; verified 29 Aug 2026)" }, "dosageForm": { "zh": "CREXONT 卡比多巴/左旋多巴缓释口服胶囊", "en": "CREXONT carbidopa/levodopa extended-release oral capsule" }, "route": { "zh": "口服（固定两成分缓释产品身份字段）", "en": "oral (fixed two-ingredient extended-release product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 64896-967-16", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_capsule", "primaryDisplay": { "zh": "每粒卡比多巴 35 mg＋左旋多巴 140 mg；120 粒瓶装纸盒", "en": "Carbidopa 35 mg plus levodopa 140 mg per capsule; carton containing a 120-capsule bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=crexont-carbidopa-and-levodopa-extended-release-ca-3.jpg&setid=095a08b6-b0b8-4f88-b759-67e8b87287a0", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "卡比多巴", "en": "carbidopa" }, "value": 35, "unit": "mg", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒第一成分标签量；不是个人剂量或换算式", "en": "labelled amount of the first ingredient per capsule; not an individual dose or conversion" } }, { "ingredient": { "zh": "左旋多巴", "en": "levodopa" }, "value": 140, "unit": "mg", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒第二成分标签量；不是个人剂量或与其他制剂的换算式", "en": "labelled amount of the second ingredient per capsule; not an individual dose or conversion from another formulation" } } ], "concentration": null, "container": { "typeCode": "bottle_in_carton", "typeLabel": { "zh": "纸盒内瓶装", "en": "bottle in carton" }, "fill": null, "countPerPackage": 120, "countUnit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-29", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "current_regulatory_listing_not_inventory", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 120, "unit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "physicalClues": { "color": { "zh": "白色胶囊体、黄色胶囊帽", "en": "white body and yellow cap" }, "shape": { "zh": "两节缓释胶囊；不能由外形推定可分半、咀嚼或压碎", "en": "two-piece extended-release capsule; form does not imply permission to halve, chew or crush" }, "imprint": "IPX203 / 140", "scoreStatus": "capsule_not_a_split_tablet", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_aa0ce11a0deb03ae", "label": "DailyMed（NLM）：CREXONT 35/140 mg、NDC 64896-967-16、120 粒包装美国公开标签面板", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=095a08b6-b0b8-4f88-b759-67e8b87287a0", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-crexont-carbidopa-35mg-levodopa-140mg-120-capsule-carton-ndc-6489696723", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（SPL v19，2026-05-29 更新；2026-08-29 核验）", "en": "Current U.S. DailyMed public label (SPL v19, updated 29 May 2026; verified 29 Aug 2026)" }, "dosageForm": { "zh": "CREXONT 卡比多巴/左旋多巴缓释口服胶囊", "en": "CREXONT carbidopa/levodopa extended-release oral capsule" }, "route": { "zh": "口服（固定两成分缓释产品身份字段）", "en": "oral (fixed two-ingredient extended-release product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 64896-967-23", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_capsule", "primaryDisplay": { "zh": "每粒卡比多巴 35 mg＋左旋多巴 140 mg；120 粒瓶装纸盒", "en": "Carbidopa 35 mg plus levodopa 140 mg per capsule; carton containing a 120-capsule bottle" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "卡比多巴", "en": "carbidopa" }, "value": 35, "unit": "mg", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒第一成分标签量；不是个人剂量或换算式", "en": "labelled amount of the first ingredient per capsule; not an individual dose or conversion" } }, { "ingredient": { "zh": "左旋多巴", "en": "levodopa" }, "value": 140, "unit": "mg", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒第二成分标签量；不是个人剂量或与其他制剂的换算式", "en": "labelled amount of the second ingredient per capsule; not an individual dose or conversion from another formulation" } } ], "concentration": null, "container": { "typeCode": "bottle_in_carton", "typeLabel": { "zh": "纸盒内瓶装", "en": "bottle in carton" }, "fill": null, "countPerPackage": 120, "countUnit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-29", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "current_regulatory_listing_not_inventory", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 120, "unit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "physicalClues": { "color": { "zh": "白色胶囊体、黄色胶囊帽", "en": "white body and yellow cap" }, "shape": { "zh": "两节缓释胶囊；不能由外形推定可分半、咀嚼或压碎", "en": "two-piece extended-release capsule; form does not imply permission to halve, chew or crush" }, "imprint": "IPX203 / 140", "scoreStatus": "capsule_not_a_split_tablet", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_aa0ce11a0deb03ae", "label": "DailyMed（NLM）：CREXONT 35/140 mg、NDC 64896-967-23、120 粒包装美国公开标签结构化文字身份", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=095a08b6-b0b8-4f88-b759-67e8b87287a0", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-crexont-carbidopa-52-5mg-levodopa-210mg-120-capsule-carton-ndc-6489696816", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（SPL v19，2026-05-29 更新；2026-08-29 核验）", "en": "Current U.S. DailyMed public label (SPL v19, updated 29 May 2026; verified 29 Aug 2026)" }, "dosageForm": { "zh": "CREXONT 卡比多巴/左旋多巴缓释口服胶囊", "en": "CREXONT carbidopa/levodopa extended-release oral capsule" }, "route": { "zh": "口服（固定两成分缓释产品身份字段）", "en": "oral (fixed two-ingredient extended-release product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 64896-968-16", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_capsule", "primaryDisplay": { "zh": "每粒卡比多巴 52.5 mg＋左旋多巴 210 mg；120 粒瓶装纸盒", "en": "Carbidopa 52.5 mg plus levodopa 210 mg per capsule; carton containing a 120-capsule bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=crexont-carbidopa-and-levodopa-extended-release-ca-4.jpg&setid=095a08b6-b0b8-4f88-b759-67e8b87287a0", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "卡比多巴", "en": "carbidopa" }, "value": 52.5, "unit": "mg", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒第一成分标签量；不是个人剂量或换算式", "en": "labelled amount of the first ingredient per capsule; not an individual dose or conversion" } }, { "ingredient": { "zh": "左旋多巴", "en": "levodopa" }, "value": 210, "unit": "mg", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒第二成分标签量；不是个人剂量或与其他制剂的换算式", "en": "labelled amount of the second ingredient per capsule; not an individual dose or conversion from another formulation" } } ], "concentration": null, "container": { "typeCode": "bottle_in_carton", "typeLabel": { "zh": "纸盒内瓶装", "en": "bottle in carton" }, "fill": null, "countPerPackage": 120, "countUnit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-29", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "current_regulatory_listing_not_inventory", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 120, "unit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "physicalClues": { "color": { "zh": "白色胶囊体、绿色胶囊帽", "en": "white body and green cap" }, "shape": { "zh": "两节缓释胶囊；不能由外形推定可分半、咀嚼或压碎", "en": "two-piece extended-release capsule; form does not imply permission to halve, chew or crush" }, "imprint": "IPX203 / 210", "scoreStatus": "capsule_not_a_split_tablet", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_aa0ce11a0deb03ae", "label": "DailyMed（NLM）：CREXONT 52.5/210 mg、NDC 64896-968-16、120 粒包装美国公开标签面板", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=095a08b6-b0b8-4f88-b759-67e8b87287a0", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-crexont-carbidopa-52-5mg-levodopa-210mg-120-capsule-carton-ndc-6489696823", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（SPL v19，2026-05-29 更新；2026-08-29 核验）", "en": "Current U.S. DailyMed public label (SPL v19, updated 29 May 2026; verified 29 Aug 2026)" }, "dosageForm": { "zh": "CREXONT 卡比多巴/左旋多巴缓释口服胶囊", "en": "CREXONT carbidopa/levodopa extended-release oral capsule" }, "route": { "zh": "口服（固定两成分缓释产品身份字段）", "en": "oral (fixed two-ingredient extended-release product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 64896-968-23", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_capsule", "primaryDisplay": { "zh": "每粒卡比多巴 52.5 mg＋左旋多巴 210 mg；120 粒瓶装纸盒", "en": "Carbidopa 52.5 mg plus levodopa 210 mg per capsule; carton containing a 120-capsule bottle" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "卡比多巴", "en": "carbidopa" }, "value": 52.5, "unit": "mg", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒第一成分标签量；不是个人剂量或换算式", "en": "labelled amount of the first ingredient per capsule; not an individual dose or conversion" } }, { "ingredient": { "zh": "左旋多巴", "en": "levodopa" }, "value": 210, "unit": "mg", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒第二成分标签量；不是个人剂量或与其他制剂的换算式", "en": "labelled amount of the second ingredient per capsule; not an individual dose or conversion from another formulation" } } ], "concentration": null, "container": { "typeCode": "bottle_in_carton", "typeLabel": { "zh": "纸盒内瓶装", "en": "bottle in carton" }, "fill": null, "countPerPackage": 120, "countUnit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-29", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "current_regulatory_listing_not_inventory", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 120, "unit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "physicalClues": { "color": { "zh": "白色胶囊体、绿色胶囊帽", "en": "white body and green cap" }, "shape": { "zh": "两节缓释胶囊；不能由外形推定可分半、咀嚼或压碎", "en": "two-piece extended-release capsule; form does not imply permission to halve, chew or crush" }, "imprint": "IPX203 / 210", "scoreStatus": "capsule_not_a_split_tablet", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_aa0ce11a0deb03ae", "label": "DailyMed（NLM）：CREXONT 52.5/210 mg、NDC 64896-968-23、120 粒包装美国公开标签结构化文字身份", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=095a08b6-b0b8-4f88-b759-67e8b87287a0", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-crexont-carbidopa-70mg-levodopa-280mg-120-capsule-carton-ndc-6489696916", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（SPL v19，2026-05-29 更新；2026-08-29 核验）", "en": "Current U.S. DailyMed public label (SPL v19, updated 29 May 2026; verified 29 Aug 2026)" }, "dosageForm": { "zh": "CREXONT 卡比多巴/左旋多巴缓释口服胶囊", "en": "CREXONT carbidopa/levodopa extended-release oral capsule" }, "route": { "zh": "口服（固定两成分缓释产品身份字段）", "en": "oral (fixed two-ingredient extended-release product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 64896-969-16", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_capsule", "primaryDisplay": { "zh": "每粒卡比多巴 70 mg＋左旋多巴 280 mg；120 粒瓶装纸盒", "en": "Carbidopa 70 mg plus levodopa 280 mg per capsule; carton containing a 120-capsule bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=crexont-carbidopa-and-levodopa-extended-release-ca-5.jpg&setid=095a08b6-b0b8-4f88-b759-67e8b87287a0", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "卡比多巴", "en": "carbidopa" }, "value": 70, "unit": "mg", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒第一成分标签量；不是个人剂量或换算式", "en": "labelled amount of the first ingredient per capsule; not an individual dose or conversion" } }, { "ingredient": { "zh": "左旋多巴", "en": "levodopa" }, "value": 280, "unit": "mg", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒第二成分标签量；不是个人剂量或与其他制剂的换算式", "en": "labelled amount of the second ingredient per capsule; not an individual dose or conversion from another formulation" } } ], "concentration": null, "container": { "typeCode": "bottle_in_carton", "typeLabel": { "zh": "纸盒内瓶装", "en": "bottle in carton" }, "fill": null, "countPerPackage": 120, "countUnit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-29", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "current_regulatory_listing_not_inventory", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 120, "unit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "physicalClues": { "color": { "zh": "白色胶囊体、紫色胶囊帽", "en": "white body and purple cap" }, "shape": { "zh": "两节缓释胶囊；不能由外形推定可分半、咀嚼或压碎", "en": "two-piece extended-release capsule; form does not imply permission to halve, chew or crush" }, "imprint": "IPX203 / 280", "scoreStatus": "capsule_not_a_split_tablet", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_aa0ce11a0deb03ae", "label": "DailyMed（NLM）：CREXONT 70/280 mg、NDC 64896-969-16、120 粒包装美国公开标签面板", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=095a08b6-b0b8-4f88-b759-67e8b87287a0", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-crexont-carbidopa-70mg-levodopa-280mg-120-capsule-carton-ndc-6489696923", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（SPL v19，2026-05-29 更新；2026-08-29 核验）", "en": "Current U.S. DailyMed public label (SPL v19, updated 29 May 2026; verified 29 Aug 2026)" }, "dosageForm": { "zh": "CREXONT 卡比多巴/左旋多巴缓释口服胶囊", "en": "CREXONT carbidopa/levodopa extended-release oral capsule" }, "route": { "zh": "口服（固定两成分缓释产品身份字段）", "en": "oral (fixed two-ingredient extended-release product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 64896-969-23", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_capsule", "primaryDisplay": { "zh": "每粒卡比多巴 70 mg＋左旋多巴 280 mg；120 粒瓶装纸盒", "en": "Carbidopa 70 mg plus levodopa 280 mg per capsule; carton containing a 120-capsule bottle" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "卡比多巴", "en": "carbidopa" }, "value": 70, "unit": "mg", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒第一成分标签量；不是个人剂量或换算式", "en": "labelled amount of the first ingredient per capsule; not an individual dose or conversion" } }, { "ingredient": { "zh": "左旋多巴", "en": "levodopa" }, "value": 280, "unit": "mg", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒第二成分标签量；不是个人剂量或与其他制剂的换算式", "en": "labelled amount of the second ingredient per capsule; not an individual dose or conversion from another formulation" } } ], "concentration": null, "container": { "typeCode": "bottle_in_carton", "typeLabel": { "zh": "纸盒内瓶装", "en": "bottle in carton" }, "fill": null, "countPerPackage": 120, "countUnit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-29", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "current_regulatory_listing_not_inventory", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 120, "unit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "physicalClues": { "color": { "zh": "白色胶囊体、紫色胶囊帽", "en": "white body and purple cap" }, "shape": { "zh": "两节缓释胶囊；不能由外形推定可分半、咀嚼或压碎", "en": "two-piece extended-release capsule; form does not imply permission to halve, chew or crush" }, "imprint": "IPX203 / 280", "scoreStatus": "capsule_not_a_split_tablet", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_aa0ce11a0deb03ae", "label": "DailyMed（NLM）：CREXONT 70/280 mg、NDC 64896-969-23、120 粒包装美国公开标签结构化文字身份", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=095a08b6-b0b8-4f88-b759-67e8b87287a0", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-crexont-carbidopa-87-5mg-levodopa-350mg-120-capsule-carton-ndc-6489697016", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（SPL v19，2026-05-29 更新；2026-08-29 核验）", "en": "Current U.S. DailyMed public label (SPL v19, updated 29 May 2026; verified 29 Aug 2026)" }, "dosageForm": { "zh": "CREXONT 卡比多巴/左旋多巴缓释口服胶囊", "en": "CREXONT carbidopa/levodopa extended-release oral capsule" }, "route": { "zh": "口服（固定两成分缓释产品身份字段）", "en": "oral (fixed two-ingredient extended-release product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 64896-970-16", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_capsule", "primaryDisplay": { "zh": "每粒卡比多巴 87.5 mg＋左旋多巴 350 mg；120 粒瓶装纸盒", "en": "Carbidopa 87.5 mg plus levodopa 350 mg per capsule; carton containing a 120-capsule bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=crexont-carbidopa-and-levodopa-extended-release-ca-6.jpg&setid=095a08b6-b0b8-4f88-b759-67e8b87287a0", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "卡比多巴", "en": "carbidopa" }, "value": 87.5, "unit": "mg", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒第一成分标签量；不是个人剂量或换算式", "en": "labelled amount of the first ingredient per capsule; not an individual dose or conversion" } }, { "ingredient": { "zh": "左旋多巴", "en": "levodopa" }, "value": 350, "unit": "mg", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒第二成分标签量；不是个人剂量或与其他制剂的换算式", "en": "labelled amount of the second ingredient per capsule; not an individual dose or conversion from another formulation" } } ], "concentration": null, "container": { "typeCode": "bottle_in_carton", "typeLabel": { "zh": "纸盒内瓶装", "en": "bottle in carton" }, "fill": null, "countPerPackage": 120, "countUnit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-29", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "current_regulatory_listing_not_inventory", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 120, "unit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "physicalClues": { "color": { "zh": "白色胶囊体、中橙色胶囊帽", "en": "white body and medium-orange cap" }, "shape": { "zh": "两节缓释胶囊；不能由外形推定可分半、咀嚼或压碎", "en": "two-piece extended-release capsule; form does not imply permission to halve, chew or crush" }, "imprint": "IPX203 / 350", "scoreStatus": "capsule_not_a_split_tablet", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_aa0ce11a0deb03ae", "label": "DailyMed（NLM）：CREXONT 87.5/350 mg、NDC 64896-970-16、120 粒包装美国公开标签面板", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=095a08b6-b0b8-4f88-b759-67e8b87287a0", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-crexont-carbidopa-87-5mg-levodopa-350mg-120-capsule-carton-ndc-6489697023", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（SPL v19，2026-05-29 更新；2026-08-29 核验）", "en": "Current U.S. DailyMed public label (SPL v19, updated 29 May 2026; verified 29 Aug 2026)" }, "dosageForm": { "zh": "CREXONT 卡比多巴/左旋多巴缓释口服胶囊", "en": "CREXONT carbidopa/levodopa extended-release oral capsule" }, "route": { "zh": "口服（固定两成分缓释产品身份字段）", "en": "oral (fixed two-ingredient extended-release product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 64896-970-23", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_capsule", "primaryDisplay": { "zh": "每粒卡比多巴 87.5 mg＋左旋多巴 350 mg；120 粒瓶装纸盒", "en": "Carbidopa 87.5 mg plus levodopa 350 mg per capsule; carton containing a 120-capsule bottle" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "卡比多巴", "en": "carbidopa" }, "value": 87.5, "unit": "mg", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒第一成分标签量；不是个人剂量或换算式", "en": "labelled amount of the first ingredient per capsule; not an individual dose or conversion" } }, { "ingredient": { "zh": "左旋多巴", "en": "levodopa" }, "value": 350, "unit": "mg", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒第二成分标签量；不是个人剂量或与其他制剂的换算式", "en": "labelled amount of the second ingredient per capsule; not an individual dose or conversion from another formulation" } } ], "concentration": null, "container": { "typeCode": "bottle_in_carton", "typeLabel": { "zh": "纸盒内瓶装", "en": "bottle in carton" }, "fill": null, "countPerPackage": 120, "countUnit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-29", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "current_regulatory_listing_not_inventory", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 120, "unit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "physicalClues": { "color": { "zh": "白色胶囊体、中橙色胶囊帽", "en": "white body and medium-orange cap" }, "shape": { "zh": "两节缓释胶囊；不能由外形推定可分半、咀嚼或压碎", "en": "two-piece extended-release capsule; form does not imply permission to halve, chew or crush" }, "imprint": "IPX203 / 350", "scoreStatus": "capsule_not_a_split_tablet", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_aa0ce11a0deb03ae", "label": "DailyMed（NLM）：CREXONT 87.5/350 mg、NDC 64896-970-23、120 粒包装美国公开标签结构化文字身份", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=095a08b6-b0b8-4f88-b759-67e8b87287a0", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-crexont-carbidopa-35mg-levodopa-140mg-120-capsule-carton-ndc-6489696716", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=crexont-carbidopa-and-levodopa-extended-release-ca-3.jpg&setid=095a08b6-b0b8-4f88-b759-67e8b87287a0", "alt": "DailyMed 当前 CREXONT 35/140 mg、NDC 64896-967-16、120 粒纸盒标签面板", "archiveMarket": "美国", "labelVersion": "DailyMed 美国当前公开标签（SPL v19，2026-05-29 更新）", "presentation": "CREXONT 每粒卡比多巴 35 mg / 左旋多巴 140 mg，NDC 64896-967-16，120 粒瓶装纸盒。", "notice": "此图只对应 CREXONT 35/140 mg、NDC 64896-967-16、120 粒纸盒；不能代表其他规格、-23 NDC、RYTARY、SINEMET、STALEVO、其他市场或仿制药，不用于鉴定真伪，也不证明实时库存或可替代性。", "source": { "id": "src_aa0ce11a0deb03ae", "label": "DailyMed（NLM）：CREXONT 35/140 mg、NDC 64896-967-16、120 粒包装美国公开标签面板", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=095a08b6-b0b8-4f88-b759-67e8b87287a0", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } }, "visualCoverageNote": { "status": "partial_exact_visual_coverage", "title": { "zh": "八个包装身份中只有四个有精确官方展示面板", "en": "Only four of eight package identities have exact official display panels" }, "summary": { "zh": "当前 SPL 为四个 -16 NDC 提供一一对应的 120 粒纸盒面板；四个 -23 NDC 只有结构化文字身份。网页不把相同规格的 -16 图片借给 -23 包装。", "en": "The current SPL provides exact 120-capsule carton panels for the four -16 NDCs. The four -23 NDCs have structured text identity only. The site does not lend an image from a same-strength -16 pack to a -23 pack." }, "source": { "id": "src_aa0ce11a0deb03ae", "label": "DailyMed（NLM）：CREXONT 卡比多巴/左旋多巴缓释胶囊当前美国公开标签（SPL v19，2026-05-29 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=095a08b6-b0b8-4f88-b759-67e8b87287a0", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } }, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "CREXONT 说明书放大阅读：缓释胶囊、苹果酱给药与换算边界", "en": "CREXONT label reading: extended release, applesauce administration and conversion boundaries" }, "summary": { "zh": "每组双数字是同一粒胶囊内卡比多巴与左旋多巴的标签量，不是两粒药。打开胶囊撒在苹果酱上只适用于标签所写的吞咽困难场景，而且必须使用全部内容物；任何从 SINEMET、RYTARY 或其他产品的转换都由开方团队管理。", "en": "Each paired strength states carbidopa and levodopa in one capsule, not two medicines. Opening onto applesauce is limited to the labelled swallowing-difficulty method and requires the entire contents. Any transition from SINEMET, RYTARY or another product is prescriber-managed." }, "checks": [ { "zh": "整粒吞咽；不要咀嚼、分开、压碎。吞咽困难时，标签允许打开一整粒，把全部内容物撒在 1–2 汤匙苹果酱上立即吞下且不咀嚼；不能保存或只取一部分。不要与酒精同服。", "en": "Swallow whole; do not chew, divide or crush. For swallowing difficulty, the label allows opening one complete capsule, sprinkling all contents on 1–2 tablespoons of applesauce and swallowing immediately without chewing. Do not store or take only part. Do not take with alcohol." }, { "zh": "即释卡比多巴/左旋多巴不能按 1:1 自行替换。标签含专业转换表，也提到从 RYTARY 转换时按左旋多巴成分约 1:1 的临床起始信息，但这不是消费者换算规则。不要抄表、自算胶囊数、混用旧药或隔天轮换。", "en": "Immediate-release carbidopa/levodopa is not self-substitutable 1:1. The label contains professional conversion tables and clinician-facing information describing an approximately 1:1 levodopa-component transition from RYTARY, but this is not a consumer conversion rule. Do not copy tables, calculate capsules, combine old supplies or alternate products by day." }, { "zh": "与其他左旋多巴产品联用未被研究；停用 COMT 抑制剂也可能改变治疗需要。不要自行增减、叠加、停换药或快速停用。快速减量或停药后出现高热、明显僵硬、意识改变或自主神经不稳时，立即使用当地急救服务。", "en": "Use with other levodopa products has not been studied, and stopping a COMT inhibitor may alter treatment needs. Do not self-add, reduce, combine, switch or rapidly stop. Use local emergency services for high fever, marked rigidity, altered consciousness or autonomic instability after a rapid reduction or withdrawal." }, { "zh": "突然入睡、明显嗜睡、头晕、幻觉、精神症状、异常冲动或新的不自主动作需尽快联系治疗团队；驾驶或操作机器前尤其要按专业意见评估。家属或照护者可能更早观察到变化。", "en": "Sudden sleep, marked somnolence, dizziness, hallucinations, psychotic symptoms, intense urges or new involuntary movements require prompt contact with the treating team. Professional assessment is especially important before driving or operating machinery. Family or carers may notice changes earlier." }, { "zh": "2026 年标签加入维生素 B6 缺乏与相关癫痫发作警示。抑郁、意识混乱、口角炎、舌炎、皮炎、贫血、神经病变或癫痫发作需要医疗评估；抽搐、意识丧失或持续发作时立即急救。不要依据网页自行验血、补充大剂量 B6 或停换药。", "en": "The 2026 label added vitamin B6 deficiency and associated seizure warnings. Depression, confusion, cheilosis, glossitis, dermatitis, anaemia, neuropathy or seizures needs clinical assessment; use emergency care for convulsions, loss of consciousness or ongoing seizures. Do not arrange tests, take high-dose B6 or stop/switch treatment from the site." }, { "zh": "非选择性 MAO 抑制剂及停药不足两周属于禁忌边界；铁盐或含铁复合维生素可能降低生物利用度，多巴胺 D2 拮抗剂（包括甲氧氯普胺）可能降低疗效。请把处方药、非处方药、补充剂和酒精放在同一张清单交给药师核对。", "en": "Nonselective MAO inhibitors, including use within the previous two weeks, form a contraindication boundary. Iron salts or iron-containing multivitamins may reduce bioavailability, and dopamine D2 antagonists including metoclopramide may reduce effectiveness. Put prescriptions, non-prescription medicines, supplements and alcohol on one list for pharmacist review." }, { "zh": "高脂高热量餐可能使左旋多巴峰值延迟约两小时，高蛋白餐可能降低吸收。不要自行通过跳餐、极端改变蛋白质、错开时间或改胶囊数来补偿，让治疗团队结合日常饮食与症状记录评估。", "en": "A high-fat, high-calorie meal may delay the levodopa peak by about two hours, and a high-protein meal may reduce absorption. Do not compensate by skipping meals, radically changing protein, rescheduling or changing capsule count; have the treating team review the usual diet and symptom record." }, { "zh": "标签还涉及心血管事件、既往消化性溃疡出血、青光眼眼压与妊娠动物数据。胸痛、严重气促、昏厥、呕血或黑便、急性视力变化等严重表现应使用当地紧急医疗渠道。", "en": "The label also addresses cardiovascular events, upper gastrointestinal bleeding with prior peptic ulcer, intraocular pressure in glaucoma and pregnancy animal data. Use local urgent or emergency care for chest pain, severe breathlessness, fainting, vomiting blood or black stools, acute visual change or another serious presentation." } ], "source": { "id": "src_aa0ce11a0deb03ae", "label": "DailyMed（NLM）：CREXONT 卡比多巴/左旋多巴缓释胶囊当前美国公开标签（SPL v19，2026-05-29 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=095a08b6-b0b8-4f88-b759-67e8b87287a0", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "两种成分与特定缓释设计：共同成分不等于同一产品", "en": "Two ingredients and a specific extended-release design: shared ingredients do not make the same product" }, "summary": { "zh": "左旋多巴进入脑内并转化为多巴胺；卡比多巴主要减少外周左旋多巴分解。CREXONT 采用自己的即释/缓释颗粒设计以形成特定释放曲线。这个机制解释双成分与缓释身份，但不能证明与 RYTARY 或其他制剂等效，也不能生成个人转换或胶囊数。", "en": "Levodopa reaches the brain and is converted to dopamine; carbidopa mainly reduces peripheral levodopa breakdown. CREXONT uses its own immediate- and extended-release components to create a specific release profile. This explains its two ingredients and extended-release identity but cannot establish equivalence with RYTARY or another formulation or generate an individual conversion or capsule count." }, "checks": [ { "zh": "CREXONT、RYTARY、SINEMET、Sinemet CR 和 STALEVO 的释放结构或成分组合不同，共享卡比多巴/左旋多巴不能使每粒/片 mg 自动等效。", "en": "CREXONT, RYTARY, SINEMET, Sinemet CR and STALEVO differ in release design or ingredient combination. Shared carbidopa/levodopa does not make per-capsule or per-tablet milligrams automatically equivalent." }, { "zh": "苹果酱方式保留的是整粒内容物，不是把颗粒碾碎；咀嚼、压碎、只取部分或保存混合物越过标签边界。", "en": "The applesauce method preserves the entire capsule contents; it does not permit grinding pellets. Chewing, crushing, taking part or storing the mixture crosses the label boundary." }, { "zh": "机理不能判断个人何时换制剂、如何处理漏服、需要什么监测或是否适合某一规格；这些必须结合准确药盒、症状记录与完整药单由治疗团队评估。", "en": "Mechanism cannot decide when an individual should change formulation, respond to missed use, receive monitoring or use a strength. The treating team must review the exact pack, symptom record and complete medicine list." } ], "source": { "id": "src_aa0ce11a0deb03ae", "label": "DailyMed（NLM）：CREXONT 卡比多巴/左旋多巴缓释胶囊当前美国公开标签（SPL v19，2026-05-29 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=095a08b6-b0b8-4f88-b759-67e8b87287a0", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "CREXONT", "generic": "卡比多巴/左旋多巴缓释胶囊", "dosageFormClass": "卡比多巴/左旋多巴固定两成分缓释口服胶囊：35/140、52.5/210、70/280、87.5/350 mg；每组数字属于同一粒胶囊内两种成分；CREXONT 与 RYTARY、SINEMET、STALEVO 等是不同产品，不能把标签数字当成个人换算表" }, "labelSource": { "id": "src_aa0ce11a0deb03ae", "label": "DailyMed（NLM）：CREXONT 卡比多巴/左旋多巴缓释胶囊当前美国公开标签（SPL v19，2026-05-29 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=095a08b6-b0b8-4f88-b759-67e8b87287a0", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "productRoutes": [ { "source": { "id": "src_aa0ce11a0deb03ae", "label": "DailyMed（NLM）：CREXONT 卡比多巴/左旋多巴缓释胶囊当前美国公开标签（SPL v19，2026-05-29 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=095a08b6-b0b8-4f88-b759-67e8b87287a0", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-29", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_10e511bf83430e3b", "label": "FDA Orange Book 当前数据：CREXONT，NDA 217186，四个规格均为处方 RLD；87.5/350 mg 同时为 RS", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-08-29", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_9ddcb06f7196a1e3", "label": "FDA Drugs@FDA 官方检索入口：CREXONT NDA 217186 申请、标签与补充申请记录", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-08-29", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-29", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [ { "id": "fda-2026-crexont-carbidopa-levodopa-vitamin-b6-seizure-safety-communication", "issuedAt": "2026-03-20", "status": "fda_drug_safety_communication", "title": { "zh": "FDA 药物安全通讯：CREXONT 等含卡比多巴/左旋多巴产品的维生素 B6 缺乏与癫痫发作警告", "en": "FDA Drug Safety Communication: vitamin B6 deficiency and seizures warning for CREXONT and other carbidopa/levodopa products" }, "summary": { "zh": "FDA 于 2026-03-20 发布安全通讯，要求所有含卡比多巴/左旋多巴产品加入维生素 B6 缺乏及相关癫痫发作警告；CREXONT 当前标签已纳入这项警示。该通讯不能判断个人是否缺乏、是否需要检测或补充，也不支持自行停药、换成 RYTARY／SINEMET／STALEVO、改变胶囊数或调整时间。癫痫发作、意识丧失或持续抽搐时立即使用当地急救服务；其他疑似表现请让开方团队结合准确产品和完整药单评估。", "en": "On 20 Mar 2026, FDA issued a Drug Safety Communication requiring every carbidopa/levodopa product to add a warning about vitamin B6 deficiency and associated seizures; the current CREXONT label includes this warning. It cannot determine an individual's deficiency, testing or supplementation need and does not support self-stopping, switching to RYTARY, SINEMET or STALEVO, changing capsule count or altering timing. Use local emergency services for a seizure, loss of consciousness or ongoing convulsions; have the prescribing team assess other suspected symptoms using the exact product and complete medicine list." }, "source": { "id": "src_8e24316f2d733113", "label": "FDA：2026-03-20 含卡比多巴/左旋多巴产品维生素 B6 缺乏与癫痫发作药物安全通讯", "url": "https://www.fda.gov/drugs/drug-safety-communications/fda-requiring-warning-about-vitamin-b6-deficiency-and-associated-seizures-drug-products-containing", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "CREXONT 是卡比多巴/左旋多巴缓释胶囊，但不是 RYTARY、SINEMET 或 STALEVO 的另一种包装。现行标签明确：即释卡比多巴/左旋多巴不能按 1:1 自行替换为 CREXONT；与其他左旋多巴产品的联用也未被研究。吞咽困难时可把一整粒的全部内容物撒在 1–2 汤匙苹果酱上立即吞下且不咀嚼；不能只取一部分、保存、压碎或饮酒同服。网页不提供个人转换表、胶囊数、间隔、漏服或停药方案。", "history": "FDA 于 2024-08-07 批准 CREXONT（IPX203）NDA 217186 的四个缓释胶囊规格。2026 年 S-008 补充申请更新吞咽困难者的苹果酱给药文字，S-011 及 FDA 类别安全通讯加入维生素 B6 缺乏与相关癫痫发作警示。当前 DailyMed SPL v19 于 2026-05-29 更新。标签所列 Initial U.S. Approval: 1975 指卡比多巴/左旋多巴组合历史，不是 CREXONT 品牌在 1975 年获批。", "sourceDocuments": [ { "id": "src_aa0ce11a0deb03ae", "label": "DailyMed（NLM）：CREXONT 卡比多巴/左旋多巴缓释胶囊当前美国公开标签（SPL v19，2026-05-29 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=095a08b6-b0b8-4f88-b759-67e8b87287a0", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, { "id": "src_10e511bf83430e3b", "label": "FDA Orange Book 当前数据：CREXONT，NDA 217186，四个规格均为处方 RLD；87.5/350 mg 同时为 RS", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, { "id": "src_9ddcb06f7196a1e3", "label": "FDA Drugs@FDA 官方检索入口：CREXONT NDA 217186 申请、标签与补充申请记录", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, { "id": "src_86201a2d9211e9a1", "label": "FDA：CREXONT NDA 217186 原始批准记录（四个规格；2024-08-07）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2025/217186Orig1s000Approv.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_regulatory_record", "documentKind": "regulatory_review", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_pdf", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, { "id": "src_584d8b322b235466", "label": "FDA：CREXONT NDA 217186/S-008 吞咽困难者苹果酱给药标签补充批准函（2026）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/217186Orig1s008ltr.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_regulatory_record", "documentKind": "regulatory_review", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_pdf", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, { "id": "src_2cf7a7a8ce9a5b6c", "label": "FDA：CREXONT NDA 217186/S-011 维生素 B6 缺乏与相关癫痫发作标签补充批准函（2026）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/217186Orig1s011ltr.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_regulatory_record", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_pdf", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, { "id": "src_8e24316f2d733113", "label": "FDA：2026-03-20 含卡比多巴/左旋多巴产品维生素 B6 缺乏与癫痫发作药物安全通讯", "url": "https://www.fda.gov/drugs/drug-safety-communications/fda-requiring-warning-about-vitamin-b6-deficiency-and-associated-seizures-drug-products-containing", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } ], "applicationNumber": "FDA NDA 217186（CREXONT / carbidopa and levodopa extended-release capsules）", "approvalTimeline": [ { "date": "2024-08-07", "title": { "zh": "CREXONT 四个缓释胶囊规格获批", "en": "Four CREXONT extended-release capsule strengths approved" }, "detail": { "zh": "FDA 原始批准记录确认 NDA 217186 的 35/140、52.5/210、70/280 与 87.5/350 mg 四规格；当前 Orange Book 均列处方 RLD。", "en": "The FDA original approval record confirms NDA 217186 strengths 35/140, 52.5/210, 70/280 and 87.5/350 mg; current Orange Book data list all four as prescription RLD products." }, "source": { "id": "src_86201a2d9211e9a1", "label": "FDA：CREXONT NDA 217186 原始批准记录（四个规格；2024-08-07）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2025/217186Orig1s000Approv.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_regulatory_record", "documentKind": "regulatory_review", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_pdf", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } }, { "date": "2026-03-20", "title": { "zh": "FDA 发布维生素 B6 缺乏与癫痫发作安全通讯", "en": "FDA issued vitamin B6 deficiency and seizure safety communication" }, "detail": { "zh": "通讯覆盖含卡比多巴/左旋多巴产品，不判断个人是否缺乏、是否需补充或是否应停药。", "en": "The communication covers carbidopa/levodopa products and does not determine individual deficiency, supplementation or stopping." }, "source": { "id": "src_8e24316f2d733113", "label": "FDA：2026-03-20 含卡比多巴/左旋多巴产品维生素 B6 缺乏与癫痫发作药物安全通讯", "url": "https://www.fda.gov/drugs/drug-safety-communications/fda-requiring-warning-about-vitamin-b6-deficiency-and-associated-seizures-drug-products-containing", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "date": "2026-05-29", "title": { "zh": "当前 DailyMed 页面更新", "en": "Current DailyMed page updated" }, "detail": { "zh": "SPL v19 列四规格、八个结构化包装 NDC、四个精确纸盒面板、苹果酱规则及 B6 安全信息。", "en": "SPL v19 lists four strengths, eight structured package NDCs, four exact carton panels, the applesauce method and B6 safety information." }, "source": { "id": "src_aa0ce11a0deb03ae", "label": "DailyMed（NLM）：CREXONT 卡比多巴/左旋多巴缓释胶囊当前美国公开标签（SPL v19，2026-05-29 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=095a08b6-b0b8-4f88-b759-67e8b87287a0", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } }, { "date": "2026-08-29", "title": { "zh": "Orange Book 身份核验", "en": "Orange Book identity reviewed" }, "detail": { "zh": "四规格均为处方 RLD，87.5/350 mg 同时为 RS。", "en": "All four strengths are prescription RLD products; 87.5/350 mg is also the RS." }, "source": { "id": "src_10e511bf83430e3b", "label": "FDA Orange Book 当前数据：CREXONT，NDA 217186，四个规格均为处方 RLD；87.5/350 mg 同时为 RS", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "四个处方 RLD；87.5/350 mg 同时为 RS；当前 SPL 列八个包装 NDC", "en": "Four prescription RLD products; 87.5/350 mg is also RS; current SPL lists eight package NDCs" }, "detail": { "zh": "四个 -16 NDC 有精确纸盒面板；四个 -23 NDC 保持文字身份。监管记录不等于库存、购买资格或个人可替换性。", "en": "Four -16 NDCs have exact carton panels; four -23 NDCs retain text identity. Regulatory records do not establish stock, purchasing eligibility or individual interchangeability." } }, { "market": { "zh": "中国大陆及其他市场", "en": "Mainland China and other markets" }, "status": { "zh": "待逐项建立现行市场记录", "en": "Current market record not established" }, "detail": { "zh": "不从美国品牌、共同成分、颜色或双数字推定当地批准、商品名、包装、供应或可替代性。", "en": "No local approval, trade name, pack, supply or interchangeability is inferred from the U.S. brand, shared ingredients, colours or paired numbers." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "CREXONT 胶囊能打开只吃一半吗？", "en": "Can a CREXONT capsule be opened and half taken?" }, "answer": { "zh": "不能。吞咽困难时可打开，但必须把一整粒的全部内容物撒在 1–2 汤匙苹果酱上立即吞下且不咀嚼；不能分半、估算颗粒、压碎或保存。", "en": "No. For swallowing difficulty it may be opened only when all contents of one complete capsule are sprinkled on 1–2 tablespoons of applesauce and swallowed immediately without chewing. Do not halve, estimate pellets, crush or store." } }, { "question": { "zh": "CREXONT、RYTARY 和 SINEMET 能按左旋多巴毫克直接换吗？", "en": "Can CREXONT, RYTARY and SINEMET be switched directly by levodopa milligrams?" }, "answer": { "zh": "不能自行换算。标签中的转换信息是专业人员管理治疗的起点，不是消费者计算器；请携带所有药盒、实际处方和症状记录由开方团队核对。", "en": "Do not self-convert. Label transition information is a clinician-managed starting point, not a consumer calculator. Take every pack, the actual prescription and symptom record to the prescribing team." } }, { "question": { "zh": "为什么八个 NDC 只有四张图？", "en": "Why do eight NDCs have only four images?" }, "answer": { "zh": "当前 SPL 只为四个 -16 NDC 提供精确纸盒面板；四个 -23 NDC 只有结构化文字身份。网页不重复借用可能造成误认的图片。", "en": "The current SPL provides exact carton panels only for the four -16 NDCs. The four -23 NDCs have structured text identity only, so the site does not reuse potentially misleading images." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "how-to-read-a-drug-label", "dosage-forms-are-part-of-medicine-identity", "family-medicine-list-for-pharmacist" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/crexont/", "en": "https://origindrug.com/en/drugs/crexont/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "biaxin", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-29", "status": "published_traceable_archive" }, "names": { "brand": "BIAXIN", "generic": "克拉霉素", "aliases": [ "Biaxin Filmtab", "BIAXIN XL", "Biaxin Granules", "clarithromycin", "clarithromycin tablets", "clarithromycin extended-release tablets", "clarithromycin for oral suspension", "克拉霉素", "克拉霉素片", "克拉霉素缓释片", "克拉霉素口服混悬剂", "clarithromycin extended release", "NDA 050662", "NDA 050698", "NDA 050775", "54868-3820-0", "54868-2338-2", "54868-4191-0", "54868-4919-0", "54868-3384-0", "KT", "KL", "KJ" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "感染", "sourceArchiveMarket": "美国：FDA Orange Book 2026-08-26 数据将 BIAXIN 250/500 mg 普通片、BIAXIN 125/250 mg/5 mL 混悬剂与 BIAXIN XL 500 mg 缓释片五个历史产品行列为 RLD，Product Type 均为 Discontinued、RS 均为 No。本页的 2012 DailyMed 页面明确是再包装历史标签；2026 年克拉霉素普通片标签只用于现行成分级安全对照，不证明 BIAXIN 品牌当前供应。", "dosageFormClass": "克拉霉素口服产品历史档案：BIAXIN 250/500 mg 普通片、BIAXIN XL 500 mg 缓释片、BIAXIN 复溶后 125/250 mg/5 mL 混悬剂；相同成分不表示普通片、缓释片和液体可按 mg 自行互换", "dosageFormClassCode": "oral_modified_release", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "1991", "archiveSponsorText": "AbbVie Inc.（FDA Orange Book 当前申请主体）；历史 DailyMed 标签由 Physicians Total Care, Inc. 再包装发布" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [ "azithromycin", "ZITHROMAX", "erythromycin", "KLACID", "clarithromycin injection", "克拉霉素注射剂" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-historical-repackaged-biaxin-clarithromycin-250mg-20-tablet-bottle-ndc-54868-3820-0", "marketCode": "US", "labelVersion": { "zh": "DailyMed 历史再包装公开标签（2012-02-22 更新）；FDA Orange Book 当前状态另行核对", "en": "Historical DailyMed repackaged public label (updated 22 Feb 2012); current FDA Orange Book status checked separately" }, "dosageForm": { "zh": "BIAXIN 克拉霉素普通薄膜衣片", "en": "BIAXIN clarithromycin immediate-release film-coated tablet" }, "route": { "zh": "口服（历史准确产品身份字段）", "en": "oral (historical exact-product identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 54868-3820-0", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片克拉霉素 250 mg；20 片瓶装", "en": "Clarithromycin 250 mg per tablet; 20 tablets in a bottle" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "克拉霉素", "en": "clarithromycin" }, "value": 250, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、频率、疗程或与另一剂型的换算式", "en": "labelled amount per tablet; not an individual's tablet count, frequency, course or conversion from another form" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "a bottle" }, "fill": null, "countPerPackage": 20, "countUnit": { "zh": "片/包装", "en": "tablets per pack" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-29", "currentLabelDisplayed": false, "ndcDirectoryListed": false, "marketAvailability": "historical_repackaged_label_not_current_supply", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 20, "unit": { "zh": "片/包装", "en": "tablets per pack" } }, "physicalClues": { "color": { "zh": "黄色", "en": "yellow" }, "shape": { "zh": "椭圆形、约 15 mm、无刻痕", "en": "oval, approximately 15 mm, unscored" }, "imprint": "KT", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_2c5c8ff462870e88", "label": "DailyMed（NLM）：BIAXIN 克拉霉素 250 mg、NDC 54868-3820-0、20 片瓶装历史再包装标签文字身份", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=2e899f4a-a2e9-445c-a0ed-6ad811e997e6", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-historical-repackaged-biaxin-clarithromycin-500mg-14-tablet-bottle-ndc-54868-2338-2", "marketCode": "US", "labelVersion": { "zh": "DailyMed 历史再包装公开标签（2012-02-22 更新）；FDA Orange Book 当前状态另行核对", "en": "Historical DailyMed repackaged public label (updated 22 Feb 2012); current FDA Orange Book status checked separately" }, "dosageForm": { "zh": "BIAXIN 克拉霉素普通薄膜衣片", "en": "BIAXIN clarithromycin immediate-release film-coated tablet" }, "route": { "zh": "口服（历史准确产品身份字段）", "en": "oral (historical exact-product identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 54868-2338-2", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片克拉霉素 500 mg；14 片瓶装", "en": "Clarithromycin 500 mg per tablet; 14 tablets in a bottle" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "克拉霉素", "en": "clarithromycin" }, "value": 500, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、频率、疗程或与另一剂型的换算式", "en": "labelled amount per tablet; not an individual's tablet count, frequency, course or conversion from another form" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "a bottle" }, "fill": null, "countPerPackage": 14, "countUnit": { "zh": "片/包装", "en": "tablets per pack" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-29", "currentLabelDisplayed": false, "ndcDirectoryListed": false, "marketAvailability": "historical_repackaged_label_not_current_supply", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 14, "unit": { "zh": "片/包装", "en": "tablets per pack" } }, "physicalClues": { "color": { "zh": "黄色", "en": "yellow" }, "shape": { "zh": "椭圆形、约 18 mm、无刻痕", "en": "oval, approximately 18 mm, unscored" }, "imprint": "KL", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_2c5c8ff462870e88", "label": "DailyMed（NLM）：BIAXIN 克拉霉素 500 mg、NDC 54868-2338-2、14 片瓶装历史再包装标签文字身份", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=2e899f4a-a2e9-445c-a0ed-6ad811e997e6", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-historical-repackaged-biaxin-xl-clarithromycin-500mg-20-tablet-bottle-ndc-54868-4191-0", "marketCode": "US", "labelVersion": { "zh": "DailyMed 历史再包装公开标签（2012-02-22 更新）；FDA Orange Book 当前状态另行核对", "en": "Historical DailyMed repackaged public label (updated 22 Feb 2012); current FDA Orange Book status checked separately" }, "dosageForm": { "zh": "BIAXIN XL 克拉霉素缓释薄膜衣片", "en": "BIAXIN XL clarithromycin extended-release film-coated tablet" }, "route": { "zh": "口服（历史准确产品身份字段）", "en": "oral (historical exact-product identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 54868-4191-0", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片克拉霉素 500 mg；20 片瓶装", "en": "Clarithromycin 500 mg per tablet; 20 tablets in a bottle" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "克拉霉素", "en": "clarithromycin" }, "value": 500, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、频率、疗程或与另一剂型的换算式", "en": "labelled amount per tablet; not an individual's tablet count, frequency, course or conversion from another form" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "a bottle" }, "fill": null, "countPerPackage": 20, "countUnit": { "zh": "片/包装", "en": "tablets per pack" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-29", "currentLabelDisplayed": false, "ndcDirectoryListed": false, "marketAvailability": "historical_repackaged_label_not_current_supply", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 20, "unit": { "zh": "片/包装", "en": "tablets per pack" } }, "physicalClues": { "color": { "zh": "黄色", "en": "yellow" }, "shape": { "zh": "椭圆形、约 19 mm、无刻痕", "en": "oval, approximately 19 mm, unscored" }, "imprint": "KJ", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_2c5c8ff462870e88", "label": "DailyMed（NLM）：BIAXIN XL 克拉霉素 500 mg、NDC 54868-4191-0、20 片瓶装历史再包装标签文字身份", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=2e899f4a-a2e9-445c-a0ed-6ad811e997e6", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-historical-repackaged-biaxin-clarithromycin-125mg-per-5ml-100ml-bottle-ndc-54868-4919-0", "marketCode": "US", "labelVersion": { "zh": "DailyMed 历史再包装公开标签（2012-02-22 更新）；FDA Orange Book 当前状态另行核对", "en": "Historical DailyMed repackaged public label (updated 22 Feb 2012); current FDA Orange Book status checked separately" }, "dosageForm": { "zh": "BIAXIN 克拉霉素口服混悬剂颗粒（复溶后）", "en": "BIAXIN clarithromycin granules for oral suspension (after constitution)" }, "route": { "zh": "口服（历史准确产品身份字段）", "en": "oral (historical exact-product identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 54868-4919-0", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_5_mL_after_reconstitution", "primaryDisplay": { "zh": "复溶后每 5 mL 含克拉霉素 125 mg；总量 100 mL 瓶装", "en": "Clarithromycin 125 mg per 5 mL after constitution; 100 mL bottle" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "克拉霉素", "en": "clarithromycin" }, "value": 125, "unit": "mg", "basisCode": "per_5_mL_after_reconstitution", "basisLabel": { "zh": "复溶后每 5 mL 标签标示量；不是整瓶总量、个人毫升数或家庭量具换算", "en": "labelled amount per 5 mL after constitution; not the bottle total, an individual's millilitres or a household-measure conversion" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "100 mL 瓶装", "en": "100 mL bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "mL/瓶（复溶后总量）", "en": "mL per bottle after constitution" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-29", "currentLabelDisplayed": false, "ndcDirectoryListed": false, "marketAvailability": "historical_repackaged_label_not_current_supply", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "mL/瓶（复溶后总量）", "en": "mL per bottle after constitution" } }, "physicalClues": { "color": null, "shape": null, "imprint": null, "scoreStatus": "not_applicable", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_2c5c8ff462870e88", "label": "DailyMed（NLM）：BIAXIN 克拉霉素 125 mg/5 mL、NDC 54868-4919-0、复溶后 100 mL 历史再包装标签文字身份", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=2e899f4a-a2e9-445c-a0ed-6ad811e997e6", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-historical-repackaged-biaxin-clarithromycin-250mg-per-5ml-100ml-bottle-ndc-54868-3384-0", "marketCode": "US", "labelVersion": { "zh": "DailyMed 历史再包装公开标签（2012-02-22 更新）；FDA Orange Book 当前状态另行核对", "en": "Historical DailyMed repackaged public label (updated 22 Feb 2012); current FDA Orange Book status checked separately" }, "dosageForm": { "zh": "BIAXIN 克拉霉素口服混悬剂颗粒（复溶后）", "en": "BIAXIN clarithromycin granules for oral suspension (after constitution)" }, "route": { "zh": "口服（历史准确产品身份字段）", "en": "oral (historical exact-product identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 54868-3384-0", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_5_mL_after_reconstitution", "primaryDisplay": { "zh": "复溶后每 5 mL 含克拉霉素 250 mg；总量 100 mL 瓶装", "en": "Clarithromycin 250 mg per 5 mL after constitution; 100 mL bottle" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "克拉霉素", "en": "clarithromycin" }, "value": 250, "unit": "mg", "basisCode": "per_5_mL_after_reconstitution", "basisLabel": { "zh": "复溶后每 5 mL 标签标示量；不是整瓶总量、个人毫升数或家庭量具换算", "en": "labelled amount per 5 mL after constitution; not the bottle total, an individual's millilitres or a household-measure conversion" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "100 mL 瓶装", "en": "100 mL bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "mL/瓶（复溶后总量）", "en": "mL per bottle after constitution" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-29", "currentLabelDisplayed": false, "ndcDirectoryListed": false, "marketAvailability": "historical_repackaged_label_not_current_supply", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "mL/瓶（复溶后总量）", "en": "mL per bottle after constitution" } }, "physicalClues": { "color": null, "shape": null, "imprint": null, "scoreStatus": "not_applicable", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_2c5c8ff462870e88", "label": "DailyMed（NLM）：BIAXIN 克拉霉素 250 mg/5 mL、NDC 54868-3384-0、复溶后 100 mL 历史再包装标签文字身份", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=2e899f4a-a2e9-445c-a0ed-6ad811e997e6", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "status": "withheld_repackaged_or_non_exact_visual", "title": { "zh": "未找到可与原品牌单一规格和包装一一对应的当前官方图片", "en": "No current official image was found that maps one-to-one to a single original-brand strength and pack" }, "summary": { "zh": "DailyMed 可检索页面明确标为 Physicians Total Care 再包装历史标签；为避免把再包装图、通用药图或另一个剂型图片当成 BIAXIN 原品牌外观，本页只展示五个经核对的文字身份卡，不展示包装图片。", "en": "The searchable DailyMed page is explicitly a historical Physicians Total Care repackaged label. To avoid presenting a repackaged, generic or different-form image as original-brand BIAXIN appearance, the dossier shows five reviewed text identity cards and no package image." }, "source": { "id": "src_2c5c8ff462870e88", "label": "DailyMed（NLM）：BIAXIN／BIAXIN XL 克拉霉素普通片、缓释片与混悬剂历史再包装公开标签（2012-02-22 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=2e899f4a-a2e9-445c-a0ed-6ad811e997e6", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "BIAXIN 说明书放大阅读：先分清普通片、缓释片和每 5 mL 混悬剂", "en": "BIAXIN label reading: first separate immediate-release tablets, extended-release tablets and suspension per 5 mL" }, "summary": { "zh": "同一个“克拉霉素”名称下曾有普通片、BIAXIN XL 缓释片和复溶后混悬剂三种不同口服呈现。普通片 500 mg 与缓释片 500 mg 不能只按数字自行替换；本页把每片 mg、复溶后 mg/5 mL、缓释结构、历史状态和高风险相互作用分开读，也不计算任何人的片数、毫升数、频率或疗程。", "en": "The same clarithromycin name historically covered immediate-release tablets, BIAXIN XL extended-release tablets and suspension after constitution. A 500 mg immediate-release tablet and a 500 mg extended-release tablet are not self-interchangeable from the number alone. This page separates mg per tablet, mg per 5 mL after constitution, extended-release design, historical status and higher-risk interactions; it calculates no individual's tablet count, millilitres, frequency or course." }, "checks": [ { "zh": "BIAXIN 500 mg 普通片和 BIAXIN XL 500 mg 缓释片虽然每片数字相同，却不是同一种释放产品。历史标签要求 BIAXIN XL 随餐并整片吞服，不得咀嚼、掰开或压碎；不能因都是 500 mg 就自行互换、叠加或轮换。", "en": "BIAXIN 500 mg immediate-release tablets and BIAXIN XL 500 mg extended-release tablets have the same number per tablet but are not the same release product. The historical label says BIAXIN XL is taken with food and swallowed whole, not chewed, broken or crushed. A shared 500 mg number does not permit self-switching, combining or alternating." }, { "zh": "混悬剂的 125 mg/5 mL 或 250 mg/5 mL 是复溶后每 5 mL 的浓度，不是整瓶总量，也不是用家用汤匙估算的个人用量。历史标签还要求每次使用前充分摇匀、不要冷藏，并在复溶后 14 天内使用；实际产品和当地现行说明必须另行核对。", "en": "Suspension 125 mg/5 mL or 250 mg/5 mL is the concentration per 5 mL after constitution, not the bottle total or an individual amount to estimate with a household spoon. The historical label also says to shake well before each use, not refrigerate and use within 14 days after mixing; the actual product and current local instructions still require separate review." }, { "zh": "当前美国克拉霉素普通片标签与历史 BIAXIN 标签都显示重要相互作用边界，包括辛伐他汀或洛伐他汀、秋水仙碱、华法林、部分心律药、钙通道阻滞剂、卡马西平及多种 CYP3A 相关药物。网页不凭药名自动判断能否同服；请把所有处方药、非处方药、保健品和实际药盒交给药师核对。", "en": "The current U.S. generic clarithromycin tablet label and historical BIAXIN label both describe important interaction boundaries involving medicines such as simvastatin or lovastatin, colchicine, warfarin, certain rhythm medicines, calcium-channel blockers, carbamazepine and other CYP3A-related products. The site does not decide co-use from names alone; give a pharmacist every prescription, OTC product, supplement and actual pack." }, { "zh": "FDA 2018 年药物安全通讯提醒：对心脏病患者开具克拉霉素时需谨慎权衡长期风险。该通讯不表示每个人都会发生问题，也不能据此自行停抗菌药或心脏药；胸痛、明显呼吸困难、单侧无力或言语不清等急症表现应立即使用当地急救服务。", "en": "FDA's 2018 Drug Safety Communication advises caution and benefit-risk review before prescribing clarithromycin to patients with heart disease. It does not mean every person will have a problem and does not support self-stopping an antibacterial or heart medicine. Chest pain, marked breathing difficulty, one-sided weakness or slurred speech requires immediate local emergency care." }, { "zh": "克拉霉素属于抗菌药，不治疗普通病毒性感冒。不要拿剩药、与家人共用、因症状相似自行改成阿奇霉素、阿莫西林或其他抗菌药，也不要自行拼接疗程。", "en": "Clarithromycin is an antibacterial and does not treat an ordinary viral cold. Do not use leftovers, share with family, switch to azithromycin, amoxicillin or another antibacterial because symptoms look similar, or assemble a course yourself." }, { "zh": "严重或带血腹泻、明显腹痛伴发热或脱水、黄疸或深色尿、心悸或晕厥、严重皮疹或呼吸困难需要及时医疗评估；呼吸困难、晕厥、严重过敏或其他危急表现应立即使用当地急救服务。", "en": "Severe or bloody diarrhoea, marked abdominal pain with fever or dehydration, jaundice or dark urine, palpitations or fainting, severe rash or breathing difficulty needs prompt medical assessment. Trouble breathing, fainting, severe allergy or another emergency requires immediate local emergency care." } ], "source": { "id": "src_2c5c8ff462870e88", "label": "DailyMed（NLM）：BIAXIN／BIAXIN XL 克拉霉素普通片、缓释片与混悬剂历史再包装公开标签（2012-02-22 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=2e899f4a-a2e9-445c-a0ed-6ad811e997e6", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "克拉霉素怎样起作用：抑制细菌蛋白质合成，但机制不能代替病原与相互作用核对", "en": "How clarithromycin works: inhibiting bacterial protein synthesis does not replace organism or interaction review" }, "summary": { "zh": "克拉霉素是大环内酯类抗菌药，通过与细菌核糖体 50S 亚基结合抑制蛋白质合成。它还涉及 CYP3A 和转运体相互作用，因此“同类抗菌药”或“同样 500 mg”都不能用作自行替换依据。", "en": "Clarithromycin is a macrolide antibacterial that binds to the bacterial 50S ribosomal subunit and inhibits protein synthesis. It also involves CYP3A and transporter interactions, so a shared antibacterial class or the same 500 mg number cannot justify self-substitution." }, "checks": [ { "zh": "药物作用于细菌蛋白质合成，不等于仅凭咳嗽、发热、咽痛或痰色就能判断病因、敏感性或是否需要抗菌药。", "en": "Acting on bacterial protein synthesis does not allow cough, fever, sore throat or sputum colour alone to identify the cause, susceptibility or need for an antibacterial." }, { "zh": "普通片和缓释片的释放速度不同；mg 数字只描述每片标示量，不描述吸收曲线、个人频次或可互换性。", "en": "Immediate- and extended-release tablets have different release profiles. The mg number describes labelled amount per tablet, not the absorption curve, individual frequency or interchangeability." }, { "zh": "CYP3A／P-gp 相互作用会使某些合用药的暴露量改变；年龄、肾肝功能、心律风险和完整药单都可能改变专业判断，网页不会生成一张人人适用的“可同服”清单。", "en": "CYP3A/P-gp interactions can change exposure to some co-medications. Age, kidney and liver function, rhythm risk and the complete medicine list can change professional judgement, so the site does not generate a universal co-use list." } ], "source": { "id": "src_62627375eee202d9", "label": "DailyMed（NLM）：克拉霉素 500 mg 普通薄膜衣片当前美国公开标签（2026-03-05 发布；非 BIAXIN 品牌身份）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=fa69ea92-0b41-43fb-918f-ed80e0dedf04", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "BIAXIN", "generic": "克拉霉素", "dosageFormClass": "克拉霉素口服产品历史档案：BIAXIN 250/500 mg 普通片、BIAXIN XL 500 mg 缓释片、BIAXIN 复溶后 125/250 mg/5 mL 混悬剂；相同成分不表示普通片、缓释片和液体可按 mg 自行互换" }, "labelSource": { "id": "src_2c5c8ff462870e88", "label": "DailyMed（NLM）：BIAXIN／BIAXIN XL 克拉霉素普通片、缓释片与混悬剂历史再包装公开标签（2012-02-22 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=2e899f4a-a2e9-445c-a0ed-6ad811e997e6", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "productRoutes": [ { "source": { "id": "src_2c5c8ff462870e88", "label": "DailyMed（NLM）：BIAXIN／BIAXIN XL 克拉霉素普通片、缓释片与混悬剂历史再包装公开标签（2012-02-22 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=2e899f4a-a2e9-445c-a0ed-6ad811e997e6", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-29", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_62627375eee202d9", "label": "DailyMed（NLM）：当前美国克拉霉素标签中的冠心病患者长期全因死亡风险警示（用于承接 FDA 2018-02-22 安全通讯的现行标签证据）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=fa69ea92-0b41-43fb-918f-ed80e0dedf04", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-09-02", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_10e511bf83430e3b", "label": "FDA Orange Book 当前数据：BIAXIN／BIAXIN XL 的五个历史 RLD 产品行均列为 Discontinued", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-08-29", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-29", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [ { "id": "fda-2018-clarithromycin-biaxin-heart-disease-long-term-risk-communication", "issuedAt": "2018-02-22", "status": "fda_drug_safety_communication", "title": { "zh": "FDA 药物安全通讯：心脏病患者使用克拉霉素（BIAXIN）的潜在长期风险", "en": "FDA Drug Safety Communication: potential long-term risk with clarithromycin (BIAXIN) in patients with heart disease" }, "summary": { "zh": "FDA 于 2018-02-22 发布安全通讯，建议在心脏病患者中开具克拉霉素（BIAXIN）前谨慎权衡获益和风险，原因是长期随访资料提示治疗结束多年后可能增加心脏问题或死亡风险。该公告是美国、特定日期、特定人群背景的监管沟通；它不表示每位使用者都会发生问题，也不能据此自行停用抗菌药、心脏药或改用另一种抗菌药。胸痛、明显呼吸困难、单侧无力或言语不清等急症表现需要立即使用当地急救服务；非急症的联用与替代问题应连同实际药盒和完整药单由开方团队或药师核对。", "en": "On 22 Feb 2018, FDA issued a Drug Safety Communication advising careful benefit-risk review before prescribing clarithromycin (BIAXIN) to patients with heart disease because long-term follow-up data suggested a potential increase in heart problems or death years after treatment. This is a dated U.S. regulatory communication for a named population context. It does not mean every user will have a problem and does not support self-stopping an antibacterial or heart medicine or switching to another antibacterial. Chest pain, marked breathing difficulty, one-sided weakness or slurred speech requires immediate local emergency care; non-emergency co-use or substitution questions require the actual pack and complete medicine list to be reviewed by the prescribing team or pharmacist." }, "source": { "id": "src_62627375eee202d9", "label": "DailyMed（NLM）：当前美国克拉霉素标签中的冠心病患者长期全因死亡风险警示（用于承接 FDA 2018-02-22 安全通讯的现行标签证据）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=fa69ea92-0b41-43fb-918f-ed80e0dedf04", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" } } ], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "BIAXIN 是克拉霉素的美国历史品牌档案，曾包含普通片、缓释片和复溶后混悬剂。包装上的 500 mg 可能指普通片每片，也可能指 BIAXIN XL 每片；125 或 250 mg/5 mL 则是复溶后每 5 mL 的浓度。三类产品不能只按数字自行替换。克拉霉素与多种药物存在重要相互作用；老年人、多药联用者及心脏病、肾肝问题人群尤其应把全部药盒交给药师或开方团队逐项核对。", "history": "FDA Orange Book 记录 BIAXIN 普通片于 1991-10-31 获批，口服混悬剂于 1993-12-23 获批，BIAXIN XL 缓释片于 2000-03-03 获批。当前 Orange Book 将本页五个 RLD 产品行列为 Discontinued；2012 DailyMed 页面为再包装历史标签。FDA 2018 年另发布心脏病患者长期风险药物安全通讯。", "sourceDocuments": [ { "id": "src_2c5c8ff462870e88", "label": "DailyMed（NLM）：BIAXIN／BIAXIN XL 克拉霉素普通片、缓释片与混悬剂历史再包装公开标签（2012-02-22 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=2e899f4a-a2e9-445c-a0ed-6ad811e997e6", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, { "id": "src_62627375eee202d9", "label": "DailyMed（NLM）：克拉霉素 500 mg 普通薄膜衣片当前美国公开标签（2026-03-05 发布；非 BIAXIN 品牌身份）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=fa69ea92-0b41-43fb-918f-ed80e0dedf04", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, { "id": "src_10e511bf83430e3b", "label": "FDA Orange Book 当前数据：BIAXIN／BIAXIN XL 的五个历史 RLD 产品行均列为 Discontinued", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, { "id": "src_5ed30b676fbb9773", "label": "FDA Drugs@FDA 官方检索入口：BIAXIN NDA 050662／050698 与 BIAXIN XL NDA 050775", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_lookup_entry", "documentKind": "regulatory_lookup", "market": "US", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_62627375eee202d9", "label": "DailyMed（NLM）：当前美国克拉霉素标签中的冠心病患者长期全因死亡风险警示（用于承接 FDA 2018-02-22 安全通讯的现行标签证据）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=fa69ea92-0b41-43fb-918f-ed80e0dedf04", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, { "id": "src_99b7228016fe2074", "label": "FDA：BIAXIN／BIAXIN XL／BIAXIN Granules 2013 年相互作用、警告与上市后不良反应标签补充批准函", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050662Orig1s052%2Cs053%2C050698Orig1s031%2Cs032%2C050775Orig1s020%2Cs021ltr.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "approval_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } ], "applicationNumber": "FDA NDA 050662（BIAXIN 普通片）／050698（混悬剂）／050775（BIAXIN XL 缓释片）", "approvalTimeline": [ { "date": "1991-10-31", "title": { "zh": "BIAXIN 250/500 mg 普通片获批", "en": "BIAXIN 250/500 mg immediate-release tablets approved" }, "detail": { "zh": "FDA Orange Book 将 NDA 050662 的 250 mg 与 500 mg 产品行列为历史 RLD；当前 Product Type 为 Discontinued、RS 为 No。", "en": "FDA Orange Book lists the NDA 050662 250 mg and 500 mg product rows as historical RLD products; current Product Type is Discontinued and RS is No." }, "source": { "id": "src_10e511bf83430e3b", "label": "FDA Orange Book 当前数据：BIAXIN／BIAXIN XL 的五个历史 RLD 产品行均列为 Discontinued", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } }, { "date": "1993-12-23", "title": { "zh": "BIAXIN 125/250 mg/5 mL 混悬剂产品获批", "en": "BIAXIN 125/250 mg per 5 mL suspension products approved" }, "detail": { "zh": "FDA Orange Book 将 NDA 050698 的 125 mg/5 mL 与 250 mg/5 mL 产品行列为历史 RLD；本档案不纳入非 RLD 的 187 mg/5 mL 历史行。", "en": "FDA Orange Book lists the NDA 050698 125 mg/5 mL and 250 mg/5 mL rows as historical RLD products. This dossier does not include the non-RLD historical 187 mg/5 mL row." }, "source": { "id": "src_10e511bf83430e3b", "label": "FDA Orange Book 当前数据：BIAXIN／BIAXIN XL 的五个历史 RLD 产品行均列为 Discontinued", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } }, { "date": "2000-03-03", "title": { "zh": "BIAXIN XL 500 mg 缓释片获批", "en": "BIAXIN XL 500 mg extended-release tablet approved" }, "detail": { "zh": "FDA Orange Book 将 NDA 050775 的 500 mg 缓释片列为历史 RLD；当前 Product Type 为 Discontinued、RS 为 No。", "en": "FDA Orange Book lists the NDA 050775 500 mg extended-release tablet as a historical RLD; current Product Type is Discontinued and RS is No." }, "source": { "id": "src_10e511bf83430e3b", "label": "FDA Orange Book 当前数据：BIAXIN／BIAXIN XL 的五个历史 RLD 产品行均列为 Discontinued", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } }, { "date": "2018-02-22", "title": { "zh": "FDA 发布心脏病患者长期风险安全通讯", "en": "FDA issued long-term-risk safety communication for patients with heart disease" }, "detail": { "zh": "FDA 建议在心脏病患者中开具克拉霉素前谨慎权衡获益与风险；公告不支持个人自行停药或换药。", "en": "FDA advised careful benefit-risk review before prescribing clarithromycin to patients with heart disease; the communication does not support self-stopping or switching." }, "source": { "id": "src_62627375eee202d9", "label": "DailyMed（NLM）：当前美国克拉霉素标签中的冠心病患者长期全因死亡风险警示（用于承接 FDA 2018-02-22 安全通讯的现行标签证据）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=fa69ea92-0b41-43fb-918f-ed80e0dedf04", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" } }, { "date": "2026-03-05", "title": { "zh": "当前美国通用名克拉霉素普通片标签发布", "en": "Current U.S. generic clarithromycin immediate-release tablet label published" }, "detail": { "zh": "该标签用于核对当前成分级警示与相互作用，不把通用名产品包装或在售状态推回历史 BIAXIN 品牌。", "en": "This label supports current ingredient-level warning and interaction review; it does not transfer a generic product pack or availability status to historical BIAXIN." }, "source": { "id": "src_62627375eee202d9", "label": "DailyMed（NLM）：克拉霉素 500 mg 普通薄膜衣片当前美国公开标签（2026-03-05 发布；非 BIAXIN 品牌身份）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=fa69ea92-0b41-43fb-918f-ed80e0dedf04", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "五个历史 RLD 产品行当前均列为 Discontinued；RS 均为 No", "en": "All five historical RLD product rows are currently Discontinued; RS is No for each" }, "detail": { "zh": "历史标签可用于阅读普通片、缓释片和混悬剂边界，但不证明当前 BIAXIN 品牌库存、可购买性或可自行换成通用名产品。", "en": "The historical label supports reading boundaries among immediate-release tablets, extended-release tablets and suspension, but does not establish current BIAXIN stock, purchasing availability or self-substitution with a generic product." } }, { "market": { "zh": "中国大陆、欧盟、日本及其他市场", "en": "Mainland China, EU, Japan and other markets" }, "status": { "zh": "待逐项建立现行品牌与产品记录", "en": "Current brand and product records not yet established" }, "detail": { "zh": "不从美国 BIAXIN 品牌、NDA、共同通用名或历史再包装标签推定当地商品名、批准、规格、包装、供应、原研/仿制关系或可替代性。", "en": "No local trade name, approval, strength, pack, supply, originator/generic relationship or interchangeability is inferred from the U.S. BIAXIN brand, NDA, shared generic name or historical repackaged label." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "BIAXIN 500 mg 和 BIAXIN XL 500 mg 是一回事吗？", "en": "Are BIAXIN 500 mg and BIAXIN XL 500 mg the same?" }, "answer": { "zh": "不是。一个是普通片，一个是缓释片；相同的每片 500 mg 不代表释放方式、用法或可互换性相同。历史标签还要求 XL 整片吞服、不得掰开或压碎。", "en": "No. One is immediate release and one is extended release. The same 500 mg per tablet does not make release, administration or interchangeability the same. The historical label also says XL is swallowed whole and not broken or crushed." } }, { "question": { "zh": "125 mg/5 mL 是否表示每次喝 5 mL？", "en": "Does 125 mg/5 mL mean 5 mL each time?" }, "answer": { "zh": "不是。它只是复溶后每 5 mL 的浓度表示，不是任何人的单次毫升数。个人用量必须来自准确处方，并结合年龄、体重、感染、肾肝功能、剂型和完整药单由专业人员确认。", "en": "No. It only states concentration per 5 mL after constitution, not an individual's millilitres per use. An exact prescription and professional review of age, weight, infection, kidney and liver function, dosage form and full medicine list are required." } }, { "question": { "zh": "正在吃他汀或秋水仙碱，可以自己加克拉霉素吗？", "en": "Can clarithromycin be self-added while taking a statin or colchicine?" }, "answer": { "zh": "不要。克拉霉素与部分他汀、秋水仙碱及多种其他药有重要相互作用和禁忌边界；把准确药盒、全部药名、剂型、规格和器官功能相关信息交给药师或开方团队核对。", "en": "No. Clarithromycin has important interaction and contraindication boundaries with some statins, colchicine and many other medicines. Give the exact packs, all medicine names, forms, strengths and organ-function information to a pharmacist or prescribing team." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "dosage-forms-are-part-of-medicine-identity", "family-medicine-list-for-pharmacist", "how-to-read-a-drug-label" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/biaxin/", "en": "https://origindrug.com/en/drugs/biaxin/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "coversyl", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-29", "status": "published_traceable_archive" }, "names": { "brand": "COVERSYL", "generic": "培哚普利", "aliases": [ "Coversyl", "雅施达", "perindopril", "perindopril arginine", "perindopril erbumine", "培哚普利", "培哚普利精氨酸盐", "培哚普利叔丁胺盐", "COVERSYL", "ARTG 101564", "ARTG 101568", "ARTG 101569", "DIN 02123282" ], "marketBrandNames": [ { "name": "COVERSYL", "market": { "zh": "澳大利亚", "en": "Australia" }, "evidenceStatus": "current_regulatory_record", "note": { "zh": "TGA 当前 ARTG：精氨酸盐 2.5、5、10 mg 片瓶装。", "en": "Current TGA ARTG records: perindopril arginine 2.5, 5 and 10 mg tablet bottles." }, "source": { "id": "src_55e9c1ef40b3e7fb", "label": "澳大利亚 TGA：COVERSYL 培哚普利精氨酸盐 10 mg 片瓶装（ARTG 101569）", "url": "https://www.tga.gov.au/resources/artg/101569", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } }, { "name": "COVERSYL", "market": { "zh": "加拿大", "en": "Canada" }, "evidenceStatus": "current_regulatory_record", "note": { "zh": "Health Canada 当前 DIN 02123282：叔丁胺盐 4 mg 片，Servier Canada。", "en": "Current Health Canada DIN 02123282: perindopril erbumine 4 mg tablet, Servier Canada." }, "source": { "id": "src_f569b57eee87a182", "label": "Health Canada：药品产品数据库（DPD）当前访问页；在库内核对 COVERSYL 4 mg／DIN 02123282", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_lookup_entry", "documentKind": "regulatory_lookup", "market": "CA", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-09-13", "reviewedAt": "2026-09-13" } }, { "name": "雅施达®", "market": { "zh": "中国大陆（企业产品页名称线索）", "en": "Mainland China (company product-page name cue)" }, "evidenceStatus": "company_product_page_name_and_strength_cue", "note": { "zh": "施维雅中国高血压产品页列示雅施达®／培哚普利叔丁胺片 8 mg。该页面只建立中文商品名、通用名与规格线索，不替代 NMPA 批准记录、现行说明书、准确包装、供应或可售资格核验。", "en": "Servier China's hypertension product page lists 雅施达®, perindopril tert-butylamine tablets, 8 mg. It establishes only a Chinese trade-name, generic-name and strength cue; it does not replace an NMPA approval record, current leaflet, exact pack, supply or sale-eligibility check." }, "source": { "id": "src_724bcbaddf3b0641", "label": "施维雅中国：高血压产品页列示雅施达®／培哚普利叔丁胺片 8 mg（2026-08-31 复核）", "url": "https://www.servier.com.cn/hypertension/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "first_party_product_page", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } } ], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "心血管", "sourceArchiveMarket": "澳大利亚 TGA 当前 ARTG 分别列示 COVERSYL 培哚普利精氨酸盐 2.5、5、10 mg 片瓶装，Licence status 均为 A；加拿大 Health Canada 当前数据库列示 COVERSYL 培哚普利叔丁胺盐 4 mg 片（DIN 02123282）为 Marketed，产品专论另列 2、4、8 mg 片剂与包装说明。两国盐型、强度数字和包装记录必须分开核对。", "dosageFormClass": "培哚普利口服片；澳大利亚为精氨酸盐 2.5/5/10 mg，加拿大专论为叔丁胺盐 2/4/8 mg；页面不提供盐型或毫克数换算", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "1994（加拿大当前记录的上市起始节点）；2005（澳大利亚三项 ARTG 登记节点）", "archiveSponsorText": "Servier Laboratories (Aust) Pty Ltd（澳大利亚 ARTG）；Servier Canada Inc.（加拿大 DIN）" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [ "COVERSYL PLUS", "COVERAM", "perindopril and indapamide", "perindopril and amlodipine", "培哚普利吲达帕胺", "培哚普利氨氯地平", "other perindopril product", "其他培哚普利产品" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "au-coversyl-perindopril-arginine-2-5mg-tablet-bottle-artg-101564", "marketCode": "AU", "labelVersion": { "zh": "TGA ARTG 101564（2026-08-29 核验）", "en": "TGA ARTG 101564 (verified 29 Aug 2026)" }, "dosageForm": { "zh": "COVERSYL 培哚普利精氨酸盐口服片", "en": "COVERSYL perindopril arginine oral tablet" }, "route": { "zh": "口服（产品身份字段）", "en": "oral (product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "ARTG 101564", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片培哚普利精氨酸盐 2.5 mg；瓶装（澳大利亚 TGA）", "en": "Perindopril arginine 2.5 mg per tablet; bottle (Australian TGA)" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "培哚普利精氨酸盐", "en": "perindopril arginine" }, "value": 2.5, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片澳大利亚产品标签标示量；不是与另一盐型、市场或强度的换算式", "en": "Australian labelled amount per tablet; not a conversion to another salt, market or strength" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装（TGA 产品名未列包装片数）", "en": "bottle (pack count not stated in the TGA product name)" }, "fill": null, "countPerPackage": null, "countUnit": null }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-29", "currentLabelDisplayed": true, "ndcDirectoryListed": false, "marketAvailability": "active_regulatory_record", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": null, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_58e9c6a83bb3e01c", "label": "澳大利亚 TGA：COVERSYL 培哚普利精氨酸盐 2.5 mg 片瓶装（ARTG 101564）", "url": "https://www.tga.gov.au/resources/artg/101564", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "au-coversyl-perindopril-arginine-5mg-tablet-bottle-artg-101568", "marketCode": "AU", "labelVersion": { "zh": "TGA ARTG 101568（2026-08-29 核验）", "en": "TGA ARTG 101568 (verified 29 Aug 2026)" }, "dosageForm": { "zh": "COVERSYL 培哚普利精氨酸盐口服片", "en": "COVERSYL perindopril arginine oral tablet" }, "route": { "zh": "口服（产品身份字段）", "en": "oral (product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "ARTG 101568", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片培哚普利精氨酸盐 5 mg；瓶装（澳大利亚 TGA）", "en": "Perindopril arginine 5 mg per tablet; bottle (Australian TGA)" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "培哚普利精氨酸盐", "en": "perindopril arginine" }, "value": 5, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片澳大利亚产品标签标示量；不是与另一盐型、市场或强度的换算式", "en": "Australian labelled amount per tablet; not a conversion to another salt, market or strength" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装（TGA 产品名未列包装片数）", "en": "bottle (pack count not stated in the TGA product name)" }, "fill": null, "countPerPackage": null, "countUnit": null }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-29", "currentLabelDisplayed": true, "ndcDirectoryListed": false, "marketAvailability": "active_regulatory_record", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": null, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_54e9c05c3fb3e668", "label": "澳大利亚 TGA：COVERSYL 培哚普利精氨酸盐 5 mg 片瓶装（ARTG 101568）", "url": "https://www.tga.gov.au/resources/artg/101568", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "au-coversyl-perindopril-arginine-10mg-tablet-bottle-artg-101569", "marketCode": "AU", "labelVersion": { "zh": "TGA ARTG 101569（2026-08-29 核验）", "en": "TGA ARTG 101569 (verified 29 Aug 2026)" }, "dosageForm": { "zh": "COVERSYL 培哚普利精氨酸盐口服片", "en": "COVERSYL perindopril arginine oral tablet" }, "route": { "zh": "口服（产品身份字段）", "en": "oral (product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "ARTG 101569", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片培哚普利精氨酸盐 10 mg；瓶装（澳大利亚 TGA）", "en": "Perindopril arginine 10 mg per tablet; bottle (Australian TGA)" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "培哚普利精氨酸盐", "en": "perindopril arginine" }, "value": 10, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片澳大利亚产品标签标示量；不是与另一盐型、市场或强度的换算式", "en": "Australian labelled amount per tablet; not a conversion to another salt, market or strength" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装（TGA 产品名未列包装片数）", "en": "bottle (pack count not stated in the TGA product name)" }, "fill": null, "countPerPackage": null, "countUnit": null }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-29", "currentLabelDisplayed": true, "ndcDirectoryListed": false, "marketAvailability": "active_regulatory_record", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": null, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_55e9c1ef40b3e7fb", "label": "澳大利亚 TGA：COVERSYL 培哚普利精氨酸盐 10 mg 片瓶装（ARTG 101569）", "url": "https://www.tga.gov.au/resources/artg/101569", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "status": "withheld_repackaged_or_non_exact_visual", "title": { "zh": "已建立三个澳大利亚官方文字产品身份；未用零售图或其他市场包装冒充准确药盒", "en": "Three official Australian text identities are established; no retail or other-market pack is presented as the exact pack" }, "summary": { "zh": "TGA 产品页可核对商品名、盐型、每片强度、ARTG、剂型和瓶装，但未提供可与三个产品一一对应的公开包装主展示图。加拿大专论提供片剂颜色、形状与包装文字线索，但不能反向冒充澳大利亚产品外观。因此页面透明显示图片缺口，只展示来源可追溯身份卡。", "en": "TGA product pages verify brand, salt, strength per tablet, ARTG, form and bottle presentation but do not provide a public principal-display image mapped one-to-one to all three products. The Canadian monograph supplies tablet colour, shape and packaging text clues, but these cannot stand in for Australian appearance. The page therefore discloses the image gap and shows traceable identity cards only." }, "source": { "id": "src_55e9c1ef40b3e7fb", "label": "澳大利亚 TGA：COVERSYL 培哚普利精氨酸盐 10 mg 片瓶装（ARTG 101569）", "url": "https://www.tga.gov.au/resources/artg/101569", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "COVERSYL 说明书放大阅读：先分清精氨酸盐 2.5/5/10 mg 与叔丁胺盐 2/4/8 mg", "en": "COVERSYL label reading: separate arginine 2.5/5/10 mg from erbumine 2/4/8 mg first" }, "summary": { "zh": "澳大利亚和加拿大都使用 COVERSYL 品牌，但官方记录中的盐型与毫克数字不同。共同品牌或共同活性母体不表示可以按数字自行换算；网页只帮助核对准确药盒、目标市场和现行说明书，不计算个人片数、频率、开始、停用、加药或换药。", "en": "Australia and Canada both use the COVERSYL brand, but their official records use different salts and milligram numbers. A shared brand or active moiety does not permit self-conversion from the numbers. This page only helps check the exact pack, market and current label; it calculates no individual's tablet count, frequency, start, stop, addition or switch." }, "checks": [ { "zh": "澳大利亚 5 mg 精氨酸盐与加拿大 4 mg 叔丁胺盐不是网页提供的互换公式。不要用两片 2.5 mg 自行拼成处方、把 4 mg 改成 5 mg，或按网上换算表换药；请让药师或开方团队按准确盐型、市场标签、处方和实际药盒核对。", "en": "Australian 5 mg arginine and Canadian 4 mg erbumine are not an interchange formula supplied by this site. Do not assemble a prescription from two 2.5 mg tablets, change 4 mg to 5 mg, or switch from an online conversion table. Have a pharmacist or prescriber check the exact salt, market label, prescription and pack." }, { "zh": "COVERSYL PLUS 含培哚普利与吲达帕胺，COVERAM 含培哚普利与氨氯地平；它们不是本页单方 COVERSYL。若药单同时出现复方、单方培哚普利、其他 ACE 抑制剂、利尿药或降压药，应先核对重复成分，不要自行加药或停药。", "en": "COVERSYL PLUS contains perindopril and indapamide, while COVERAM contains perindopril and amlodipine; neither is the single-ingredient COVERSYL dossier here. If a combination, single-ingredient perindopril, another ACE inhibitor, diuretic or blood-pressure medicine appears together, check duplication first and do not self-add or stop a medicine." }, { "zh": "加拿大专论列示 4 mg 浅绿色棒状有刻痕片和 8 mg 绿色圆片等外观线索。刻痕只是身份核对线索，不是所有人都能掰片或把片剂换算成另一规格的许可；实际能否分割必须回到手中产品和专业指示。", "en": "The Canadian monograph lists appearance clues including a light-green rod-shaped scored 4 mg tablet and a green round 8 mg tablet. A score is an identity clue, not universal permission to split a tablet or convert it into another strength; any splitting decision must return to the exact product and professional instruction." }, { "zh": "面、唇、舌或喉部突然肿胀，呼吸或吞咽困难，晕厥或其他严重过敏表现可能是急症，应立即使用当地急救服务。不要等待网页核实，也不要自行再次服用来“观察”。", "en": "Sudden swelling of the face, lips, tongue or throat, trouble breathing or swallowing, fainting or another severe allergic feature may be an emergency. Use local emergency services immediately; do not wait for web verification or take another tablet to ‘see what happens’." }, { "zh": "老年人、脱水、肾功能问题或同时使用 NSAID 止痛药、利尿药、保钾产品、补钾剂、锂或其他影响血压/肾功能的药物时，需要完整药单和监测计划核对。网页不凭两个药名判断能否同服、是否错开或怎样调整。", "en": "Older age, dehydration, kidney problems, or co-use of NSAID pain medicines, diuretics, potassium-sparing products, potassium supplements, lithium or other medicines affecting blood pressure or kidney function calls for full-list and monitoring review. The site does not decide co-use, separation or adjustment from two names alone." }, { "zh": "加拿大专论列有与沙库巴曲/缬沙坦相关的明确时间边界，但这不是网页可执行的自行停换药倒计时。涉及 ENTRESTO 或其他肾素-血管紧张素系统药物时，应由开方团队安排转换与监测。", "en": "The Canadian monograph contains a specific time boundary involving sacubitril/valsartan, but this is not a self-directed stop-and-switch countdown. When ENTRESTO or another renin-angiotensin-system medicine is involved, the prescribing team must coordinate the transition and monitoring." } ], "source": { "id": "src_13efa0864075ceda", "label": "Health Canada：COVERSYL 培哚普利叔丁胺盐当前产品专论与患者用药信息（2022-10-21）", "url": "https://pdf.hres.ca/dpd_pm/00067894.PDF", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_pdf", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "培哚普利怎样起作用：ACE 抑制路径不能变成个人换药或剂量规则", "en": "How perindopril works: the ACE-inhibition pathway is not a personal switching or dose rule" }, "summary": { "zh": "培哚普利在体内转化为活性代谢物培哚普利拉，抑制血管紧张素转换酶，减少血管紧张素 II 与醛固酮相关作用。该机制可帮助理解为何需要核对血压、肾功能、钾和完整药单，但不能从机制或血压数字替个人选择盐型、规格、片数、停药或联用。", "en": "Perindopril is converted to the active metabolite perindoprilat and inhibits angiotensin-converting enzyme, reducing angiotensin II- and aldosterone-related effects. This helps explain why blood pressure, kidney function, potassium and the complete medicine list matter, but neither the mechanism nor a blood-pressure number selects a salt, strength, tablet count, stop or combination for an individual." }, "checks": [ { "zh": "ACE 抑制剂是药理类别，不表示 COVERSYL、ZESTRIL、VASOTEC、ALTACE、CAPOTEN 或含共同路径的复方可以自行叠加、轮换或按 mg 换算。", "en": "ACE inhibitor is a pharmacologic class; it does not permit self-combining, alternating or milligram-converting COVERSYL, ZESTRIL, VASOTEC, ALTACE, CAPOTEN or shared-pathway combinations." }, { "zh": "血压下降机制不表示头晕就一定是药物过量，也不表示血压暂时升高就能补服。出现新症状或读数异常时，应按个人治疗计划联系医疗团队；严重胸痛、呼吸困难、晕厥或神经系统急症表现应立即使用当地急救服务。", "en": "A blood-pressure-lowering mechanism does not prove that dizziness means overdose or that a temporary higher reading permits an extra tablet. Follow the individual's care plan and contact the care team for new symptoms or unusual readings; severe chest pain, breathing difficulty, fainting or neurologic emergency features require immediate local emergency care." }, { "zh": "机制解释不能替代妊娠、肾功能、钾、脱水、药物相互作用或血管性水肿风险评估。涉及这些情况时，应尽快由医生或药师核对准确药盒和完整药单。", "en": "A mechanism explanation does not replace assessment of pregnancy, kidney function, potassium, dehydration, drug interactions or angioedema risk. When these apply, have a clinician or pharmacist promptly review the exact pack and complete medicine list." } ], "source": { "id": "src_13efa0864075ceda", "label": "Health Canada：COVERSYL 培哚普利叔丁胺盐当前产品专论与患者用药信息（2022-10-21）", "url": "https://pdf.hres.ca/dpd_pm/00067894.PDF", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_pdf", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "COVERSYL", "generic": "培哚普利", "dosageFormClass": "培哚普利口服片；澳大利亚为精氨酸盐 2.5/5/10 mg，加拿大专论为叔丁胺盐 2/4/8 mg；页面不提供盐型或毫克数换算" }, "labelSource": { "id": "src_13efa0864075ceda", "label": "Health Canada：COVERSYL 培哚普利叔丁胺盐当前产品专论与患者用药信息（2022-10-21）", "url": "https://pdf.hres.ca/dpd_pm/00067894.PDF", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_pdf", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "productRoutes": [ { "source": { "id": "src_13efa0864075ceda", "label": "Health Canada：COVERSYL 培哚普利叔丁胺盐当前产品专论与患者用药信息（2022-10-21）", "url": "https://pdf.hres.ca/dpd_pm/00067894.PDF", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_pdf", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "status": "product_level_public_record_verified", "authority": { "zh": "Health Canada", "en": "Health Canada" }, "market": { "zh": "加拿大", "en": "Canada" }, "recordType": { "zh": "监管产品记录或当前产品专论", "en": "Regulatory product record or current product monograph" }, "reviewedAt": "2026-08-29", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_54e9c05c3fb3e668", "label": "澳大利亚 TGA：COVERSYL 培哚普利精氨酸盐 5 mg 片瓶装（ARTG 101568）", "url": "https://www.tga.gov.au/resources/artg/101568", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "status": "product_level_public_record_verified", "authority": { "zh": "TGA", "en": "TGA" }, "market": { "zh": "澳大利亚", "en": "Australia" }, "recordType": { "zh": "监管产品记录或公开说明书", "en": "Regulatory product record or public product information" }, "reviewedAt": "2026-08-29", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_55e9c1ef40b3e7fb", "label": "澳大利亚 TGA：COVERSYL 培哚普利精氨酸盐 10 mg 片瓶装（ARTG 101569）", "url": "https://www.tga.gov.au/resources/artg/101569", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "status": "product_level_public_record_verified", "authority": { "zh": "TGA", "en": "TGA" }, "market": { "zh": "澳大利亚", "en": "Australia" }, "recordType": { "zh": "监管产品记录或公开说明书", "en": "Regulatory product record or public product information" }, "reviewedAt": "2026-08-29", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_58e9c6a83bb3e01c", "label": "澳大利亚 TGA：COVERSYL 培哚普利精氨酸盐 2.5 mg 片瓶装（ARTG 101564）", "url": "https://www.tga.gov.au/resources/artg/101564", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "status": "product_level_public_record_verified", "authority": { "zh": "TGA", "en": "TGA" }, "market": { "zh": "澳大利亚", "en": "Australia" }, "recordType": { "zh": "监管产品记录或公开说明书", "en": "Regulatory product record or public product information" }, "reviewedAt": "2026-08-29", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_fb5f8125a304c9a9", "label": "澳大利亚 TGA eBS：COVERSYL Product Information 官方入口", "url": "https://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent=&id=CP-2010-PI-01940-3", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "AU", "accessStatus": "public_access_requires_interaction", "accessMode": "public_document_with_terms", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "status": "product_level_public_record_verified", "authority": { "zh": "TGA", "en": "TGA" }, "market": { "zh": "澳大利亚", "en": "Australia" }, "recordType": { "zh": "监管产品记录或公开说明书", "en": "Regulatory product record or public product information" }, "reviewedAt": "2026-08-29", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "Health Canada", "en": "Health Canada" }, "market": { "zh": "加拿大", "en": "Canada" }, "recordType": { "zh": "监管产品记录或当前产品专论", "en": "Regulatory product record or current product monograph" }, "reviewedAt": "2026-08-29", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "COVERSYL 是培哚普利的跨市场品牌档案。先看盐型再看数字：澳大利亚药盒可写精氨酸盐 2.5、5、10 mg；加拿大专论写叔丁胺盐 2、4、8 mg。相近或不同的毫克数字不是自行换算表，也不能据此多片拼规格、换药或与 COVERSYL PLUS、COVERAM 等复方叠加。老年人、肾功能问题、脱水或同时使用止痛药、利尿药、降压药者，尤其应让药师或开方团队核对完整药单和实际药盒。", "history": "Health Canada 当前产品数据库将 DIN 02123282 的 COVERSYL 4 mg 片列为 Marketed，市场起始日期为 1994-12-31，持有人为 Servier Canada Inc.；当前产品专论日期为 2022-10-21。澳大利亚 TGA 将 ARTG 101564、101568、101569 的 2.5、5、10 mg 培哚普利精氨酸盐片登记日期列为 2005-06-08，当前 sponsor 为 Servier Laboratories (Aust) Pty Ltd。", "sourceDocuments": [ { "id": "src_54e9c05c3fb3e668", "label": "澳大利亚 TGA：COVERSYL 培哚普利精氨酸盐 5 mg 片瓶装（ARTG 101568）", "url": "https://www.tga.gov.au/resources/artg/101568", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, { "id": "src_55e9c1ef40b3e7fb", "label": "澳大利亚 TGA：COVERSYL 培哚普利精氨酸盐 10 mg 片瓶装（ARTG 101569）", "url": "https://www.tga.gov.au/resources/artg/101569", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, { "id": "src_58e9c6a83bb3e01c", "label": "澳大利亚 TGA：COVERSYL 培哚普利精氨酸盐 2.5 mg 片瓶装（ARTG 101564）", "url": "https://www.tga.gov.au/resources/artg/101564", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, { "id": "src_fb5f8125a304c9a9", "label": "澳大利亚 TGA eBS：COVERSYL Product Information 官方入口", "url": "https://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent=&id=CP-2010-PI-01940-3", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "AU", "accessStatus": "public_access_requires_interaction", "accessMode": "public_document_with_terms", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, { "id": "src_1ed2f8478a4fb3e3", "label": "澳大利亚 TGA eBS：COVERSYL Consumer Medicine Information 官方入口", "url": "https://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent=&id=CP-2010-CMI-02831-3", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "consumer_medicine_information", "market": "AU", "accessStatus": "public_access_requires_interaction", "accessMode": "public_document_with_terms", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, { "id": "src_f569b57eee87a182", "label": "Health Canada：药品产品数据库（DPD）当前访问页；在库内核对 COVERSYL 4 mg／DIN 02123282", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_lookup_entry", "documentKind": "regulatory_lookup", "market": "CA", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-09-13", "reviewedAt": "2026-09-13" }, { "id": "src_13efa0864075ceda", "label": "Health Canada：COVERSYL 培哚普利叔丁胺盐当前产品专论与患者用药信息（2022-10-21）", "url": "https://pdf.hres.ca/dpd_pm/00067894.PDF", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_pdf", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, { "id": "src_724bcbaddf3b0641", "label": "施维雅中国：高血压产品页列示雅施达®／培哚普利叔丁胺片 8 mg（2026-08-31 复核）", "url": "https://www.servier.com.cn/hypertension/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "first_party_product_page", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } ], "applicationNumber": "澳大利亚 ARTG 101564／101568／101569；加拿大 DIN 02123282", "approvalTimeline": [ { "date": "1994-12-31", "title": { "zh": "加拿大当前数据库所列市场起始节点", "en": "Market-start node listed in the current Canadian database" }, "detail": { "zh": "Health Canada 当前页面将 DIN 02123282 的 COVERSYL 培哚普利叔丁胺盐 4 mg 片列为 Marketed。该状态不证明具体药房库存。", "en": "The current Health Canada page lists COVERSYL perindopril erbumine 4 mg tablets, DIN 02123282, as marketed. This does not establish stock at a particular pharmacy." }, "source": { "id": "src_f569b57eee87a182", "label": "Health Canada：药品产品数据库（DPD）当前访问页；在库内核对 COVERSYL 4 mg／DIN 02123282", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_lookup_entry", "documentKind": "regulatory_lookup", "market": "CA", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-09-13", "reviewedAt": "2026-09-13" } }, { "date": "2005-06-08", "title": { "zh": "澳大利亚三个精氨酸盐强度的 ARTG 登记节点", "en": "ARTG date for three Australian arginine strengths" }, "detail": { "zh": "TGA 分别以 ARTG 101564、101568、101569 列示 2.5、5、10 mg 片瓶装，Licence status 为 A。", "en": "TGA separately lists 2.5, 5 and 10 mg tablet bottles under ARTG 101564, 101568 and 101569 with licence status A." }, "source": { "id": "src_55e9c1ef40b3e7fb", "label": "澳大利亚 TGA：COVERSYL 培哚普利精氨酸盐 10 mg 片瓶装（ARTG 101569）", "url": "https://www.tga.gov.au/resources/artg/101569", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } }, { "date": "2022-10-21", "title": { "zh": "加拿大当前产品专论日期", "en": "Current Canadian product-monograph date" }, "detail": { "zh": "专论列示叔丁胺盐 2、4、8 mg 片的外观、包装、警告、相互作用和患者信息；它不把这些数字转换为澳大利亚精氨酸盐规格。", "en": "The monograph lists appearance, packaging, warnings, interactions and patient information for erbumine 2, 4 and 8 mg tablets; it does not convert those numbers into Australian arginine strengths." }, "source": { "id": "src_13efa0864075ceda", "label": "Health Canada：COVERSYL 培哚普利叔丁胺盐当前产品专论与患者用药信息（2022-10-21）", "url": "https://pdf.hres.ca/dpd_pm/00067894.PDF", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_pdf", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } } ], "marketStatus": [ { "market": { "zh": "澳大利亚", "en": "Australia" }, "status": { "zh": "2.5、5、10 mg 精氨酸盐片 ARTG 当前 Licence status 为 A", "en": "ARTG licence status A for 2.5, 5 and 10 mg arginine tablets" }, "detail": { "zh": "监管记录不等于具体药房库存、购买资格、个人适用性或可自行换药。", "en": "A regulatory record does not establish pharmacy stock, purchasing eligibility, individual suitability or self-switching." } }, { "market": { "zh": "加拿大", "en": "Canada" }, "status": { "zh": "DIN 02123282 的 4 mg 叔丁胺盐片当前列为 Marketed", "en": "DIN 02123282 4 mg erbumine tablet is currently listed as marketed" }, "detail": { "zh": "当前专论覆盖 2、4、8 mg 片剂；具体供应和包装仍需按实际产品核对。", "en": "The current monograph covers 2, 4 and 8 mg tablets; actual supply and pack still require exact-product review." } }, { "market": { "zh": "中国大陆、美国、欧盟、日本及其他市场", "en": "Mainland China, United States, EU, Japan and other markets" }, "status": { "zh": "待逐项建立现行市场记录", "en": "Current market record not established" }, "detail": { "zh": "不从澳大利亚或加拿大记录推定当地商品名、批准、盐型、包装、供应、原研/仿制关系或可替代性。", "en": "No local trade name, approval, salt, pack, supply, originator/generic relationship or interchangeability is inferred from Australian or Canadian records." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "澳大利亚 COVERSYL 5 mg 和加拿大 COVERSYL 4 mg 是同一规格吗？", "en": "Are Australian COVERSYL 5 mg and Canadian COVERSYL 4 mg the same strength?" }, "answer": { "zh": "不能只看品牌或数字认定。澳大利亚记录是精氨酸盐 5 mg，加拿大专论是叔丁胺盐 4 mg；网页不提供自行换算或替代规则。请按准确盐型、药盒、处方和目标市场说明书让药师或开方团队核对。", "en": "Do not decide from brand or number alone. The Australian record is 5 mg arginine, while the Canadian monograph is 4 mg erbumine. This site provides no self-conversion or substitution rule; have the exact salt, pack, prescription and target-market label reviewed." } }, { "question": { "zh": "药片有刻痕，能不能掰开？", "en": "Can a scored tablet be split?" }, "answer": { "zh": "刻痕首先是外观身份线索，不是通用分片许可。不同盐型、强度、市场和厂家可能不同；请以手中准确产品的现行说明书、药师或开方团队指示为准。", "en": "A score is first an appearance-identification clue, not universal splitting permission. Salt, strength, market and manufacturer may differ; follow the current label for the exact product and professional instruction." } }, { "question": { "zh": "COVERSYL PLUS 或 COVERAM 能当作单方 COVERSYL 吗？", "en": "Can COVERSYL PLUS or COVERAM be treated as single-ingredient COVERSYL?" }, "answer": { "zh": "不能。前者另含吲达帕胺，后者另含氨氯地平。请逐项核对完整成分，避免与单方培哚普利、利尿药、氨氯地平或其他降压药重复；不要自行拆分、叠加或替换。", "en": "No. The former also contains indapamide and the latter amlodipine. Check every ingredient to avoid duplication with single-ingredient perindopril, diuretics, amlodipine or other blood-pressure medicines; do not self-disassemble, combine or substitute." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "dosage-forms-are-part-of-medicine-identity", "how-to-read-a-drug-label" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/coversyl/", "en": "https://origindrug.com/en/drugs/coversyl/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "pletal", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-29", "status": "published_traceable_archive" }, "names": { "brand": "PLETAL / Pletaal", "generic": "西洛他唑", "aliases": [ "PLETAL", "Pletaal", "プレタール", "プレタールOD", "cilostazol", "西洛他唑", "西洛他唑片", "NDA 020863", "22100AMX02276", "22100AMX02275", "59148-003-16", "59148-002-16", "OG18" ], "marketBrandNames": [ { "name": "Pletaal OD / プレタール OD", "market": { "zh": "日本", "en": "Japan" }, "evidenceStatus": "current_regulatory_record", "note": { "zh": "PMDA 当前记录：50 mg 与 100 mg 口崩片，大塚制药。", "en": "Current PMDA record: 50 mg and 100 mg orally disintegrating tablets, Otsuka." }, "source": { "id": "src_507aafb6e9d8b752", "label": "日本 PMDA：プレタール OD 錠 50 mg / 100 mg 当前专业用产品记录", "url": "https://www.pmda.go.jp/PmdaSearch/rdDetail/iyaku/3399002F3020_1?user=1", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } }, { "name": "PLETAL", "market": { "zh": "美国", "en": "United States" }, "evidenceStatus": "historical_public_record", "note": { "zh": "FDA 1999 原始批准及 2015/2017 历史标签；不是当前供应声明。", "en": "FDA original 1999 approval and 2015/2017 historical labels; not a current-supply claim." }, "source": { "id": "src_a771c1ffa05d2e9b", "label": "美国 FDA：PLETAL 西洛他唑 NDA 020863 原始批准信（1999-01-15）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/cilostazol_letter.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_pdf", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } } ], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "抗凝与血液", "sourceArchiveMarket": "日本 PMDA 当前记录覆盖 Pletaal OD 50 mg 与 100 mg 口崩片；美国 FDA 资料仅作为 PLETAL 50 mg 与 100 mg 普通片的 1999 原始批准及 2015/2017 历史标签档案。美国历史标签不是当前标签、当前供应或任何其他市场状态的证明。", "dosageFormClass": "日本当前为 Pletaal OD 口崩片；美国档案为历史普通口服片。相同成分和毫克数不合并产品形态、包装或市场状态。", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "1999（美国 FDA 原始批准）；2010（日本 PMDA 当前 OD 片销售起始节点）", "archiveSponsorText": "Otsuka Pharmaceutical Co., Ltd.（日本 PMDA）；Otsuka America Pharmaceutical, Inc.（美国历史 FDA 记录）" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [ "generic cilostazol", "other cilostazol product", "其他西洛他唑产品", "プレタール散20%", "cilostazol combination", "西洛他唑复方" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "jp-pletaal-od-cilostazol-50mg-tablet-22100amx02276", "marketCode": "JP", "labelVersion": { "zh": "PMDA 当前电子添付文书（2023-02 修订；2026-08-29 核验）", "en": "Current PMDA electronic label (revised Feb 2023; verified 29 Aug 2026)" }, "dosageForm": { "zh": "プレタール OD 西洛他唑口崩片", "en": "Pletaal OD cilostazol orally disintegrating tablet" }, "route": { "zh": "口服（产品身份字段）", "en": "oral (product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "22100AMX02276", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片西洛他唑 50 mg；日本口崩片", "en": "Cilostazol 50 mg per tablet; Japanese orally disintegrating tablet" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "西洛他唑", "en": "cilostazol" }, "value": 50, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片日本标签标示量；不是个人片数、频率、掰片或换算指令", "en": "Japanese labelled amount per tablet; not an individual's tablet count, frequency, splitting or conversion instruction" } } ], "concentration": null, "container": { "typeCode": "not_established", "typeLabel": { "zh": "包装数量未在本身份卡中建立", "en": "pack count not established in this identity card" }, "fill": null, "countPerPackage": null, "countUnit": null }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-29", "currentLabelDisplayed": true, "ndcDirectoryListed": false, "marketAvailability": "active_regulatory_record", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": null, "physicalClues": { "color": { "zh": "白色", "en": "white" }, "shape": { "zh": "圆形片", "en": "round tablet" }, "imprint": null, "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_0f79cd93faca2cc7", "label": "日本 PMDA：プレタール OD 錠 50 mg / 100 mg 当前电子添付文书（2023-02 修订）", "url": "https://www.pmda.go.jp/PmdaSearch/iyakuDetail/ResultDataSetPDF/180078_3399002F3020_1_11", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_pdf", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "jp-pletaal-od-cilostazol-100mg-tablet-22100amx02275", "marketCode": "JP", "labelVersion": { "zh": "PMDA 当前电子添付文书（2023-02 修订；2026-08-29 核验）", "en": "Current PMDA electronic label (revised Feb 2023; verified 29 Aug 2026)" }, "dosageForm": { "zh": "プレタール OD 西洛他唑口崩片", "en": "Pletaal OD cilostazol orally disintegrating tablet" }, "route": { "zh": "口服（产品身份字段）", "en": "oral (product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "22100AMX02275", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片西洛他唑 100 mg；日本口崩片", "en": "Cilostazol 100 mg per tablet; Japanese orally disintegrating tablet" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "西洛他唑", "en": "cilostazol" }, "value": 100, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片日本标签标示量；不是个人片数、频率、掰片或换算指令", "en": "Japanese labelled amount per tablet; not an individual's tablet count, frequency, splitting or conversion instruction" } } ], "concentration": null, "container": { "typeCode": "not_established", "typeLabel": { "zh": "包装数量未在本身份卡中建立", "en": "pack count not established in this identity card" }, "fill": null, "countPerPackage": null, "countUnit": null }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-29", "currentLabelDisplayed": true, "ndcDirectoryListed": false, "marketAvailability": "active_regulatory_record", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": null, "physicalClues": { "color": { "zh": "白色", "en": "white" }, "shape": { "zh": "圆形片", "en": "round tablet" }, "imprint": "OG18", "scoreStatus": "scored_status_not_a_split_instruction", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_0f79cd93faca2cc7", "label": "日本 PMDA：プレタール OD 錠 50 mg / 100 mg 当前电子添付文书（2023-02 修订）", "url": "https://www.pmda.go.jp/PmdaSearch/iyakuDetail/ResultDataSetPDF/180078_3399002F3020_1_11", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_pdf", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-historical-pletal-cilostazol-50mg-60-tablet-bottle-ndc-59148-003-16", "marketCode": "US", "labelVersion": { "zh": "美国 FDA 2015 历史标签（不是当前标签或供应证明）", "en": "Historical 2015 U.S. FDA label (not a current label or supply claim)" }, "dosageForm": { "zh": "PLETAL 西洛他唑普通口服片（历史美国记录）", "en": "PLETAL cilostazol conventional oral tablet (historical U.S. record)" }, "route": { "zh": "口服（历史产品身份字段）", "en": "oral (historical product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 59148-003-16", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片西洛他唑 50 mg；60 片瓶装（美国历史标签）", "en": "Cilostazol 50 mg per tablet; 60-tablet bottle (historical U.S. label)" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "西洛他唑", "en": "cilostazol" }, "value": 50, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片历史美国标签标示量；不是当前供应、个人剂量或跨市场换算", "en": "Historical U.S. labelled amount per tablet; not current supply, an individual dose or cross-market conversion" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装（历史）", "en": "bottle (historical)" }, "fill": null, "countPerPackage": 60, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-29", "currentLabelDisplayed": false, "ndcDirectoryListed": false, "marketAvailability": "historical_record_only", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 60, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "白色", "en": "white" }, "shape": { "zh": "三角形片", "en": "triangular tablet" }, "imprint": "PLETAL 50", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_0aa10e476910ee8b", "label": "美国 FDA：PLETAL 西洛他唑 50 mg / 100 mg 历史标签与包装信息（2015；不是当前标签）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020863s022lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_pdf", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-historical-pletal-cilostazol-100mg-60-tablet-bottle-ndc-59148-002-16", "marketCode": "US", "labelVersion": { "zh": "美国 FDA 2015 历史标签（不是当前标签或供应证明）", "en": "Historical 2015 U.S. FDA label (not a current label or supply claim)" }, "dosageForm": { "zh": "PLETAL 西洛他唑普通口服片（历史美国记录）", "en": "PLETAL cilostazol conventional oral tablet (historical U.S. record)" }, "route": { "zh": "口服（历史产品身份字段）", "en": "oral (historical product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 59148-002-16", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片西洛他唑 100 mg；60 片瓶装（美国历史标签）", "en": "Cilostazol 100 mg per tablet; 60-tablet bottle (historical U.S. label)" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "西洛他唑", "en": "cilostazol" }, "value": 100, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片历史美国标签标示量；不是当前供应、个人剂量或跨市场换算", "en": "Historical U.S. labelled amount per tablet; not current supply, an individual dose or cross-market conversion" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装（历史）", "en": "bottle (historical)" }, "fill": null, "countPerPackage": 60, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-29", "currentLabelDisplayed": false, "ndcDirectoryListed": false, "marketAvailability": "historical_record_only", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 60, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "白色", "en": "white" }, "shape": { "zh": "圆形片", "en": "round tablet" }, "imprint": "PLETAL 100", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_0aa10e476910ee8b", "label": "美国 FDA：PLETAL 西洛他唑 50 mg / 100 mg 历史标签与包装信息（2015；不是当前标签）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020863s022lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_pdf", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "status": "withheld_repackaged_or_non_exact_visual", "title": { "zh": "四个来源可追溯文字身份已建立；没有用零售图或跨市场包装冒充准确产品", "en": "Four traceable text identities are established; no retail or cross-market pack is presented as the exact product" }, "summary": { "zh": "PMDA 当前文书可核对日本两种口崩片的形状、尺寸与 100 mg 片印字，FDA 历史标签可核对美国两种普通片及历史瓶装信息，但目前没有与四个身份逐一对应并可安全复用的准确公开包装主图。页面因此保留图片缺口，不用通用西洛他唑、零售图或另一市场包装代替。", "en": "The current PMDA document verifies shape, size and the 100 mg imprint for the two Japanese OD tablets, while historical FDA labels verify two U.S. conventional tablets and bottle information. No exact reusable public principal-display image is mapped one-to-one to all four identities, so the page discloses the image gap and does not substitute a generic cilostazol, retail or other-market pack." }, "source": { "id": "src_0f79cd93faca2cc7", "label": "日本 PMDA：プレタール OD 錠 50 mg / 100 mg 当前电子添付文书（2023-02 修订）", "url": "https://www.pmda.go.jp/PmdaSearch/iyakuDetail/ResultDataSetPDF/180078_3399002F3020_1_11", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_pdf", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "PLETAL / Pletaal 说明书放大阅读：先核对心衰、出血、联用药和准确剂型", "en": "PLETAL / Pletaal label reading: check heart failure, bleeding, co-medications and exact dosage form first" }, "summary": { "zh": "本模块帮助辨认日本当前 Pletaal OD 口崩片与美国历史 PLETAL 普通片，并把高风险核对点提前。它不判断个人是否适用，也不生成片数、频率、开始、停用、补服、换药、术前停药或联用方案。", "en": "This module distinguishes current Japanese Pletaal OD tablets from historical U.S. PLETAL conventional tablets and brings higher-risk review cues forward. It does not decide individual suitability or generate tablet count, frequency, initiation, stopping, missed-use, switching, peri-procedure stopping or co-use plans." }, "checks": [ { "zh": "日本 OD 是口崩片产品身份，不表示可以把药片任意压碎、溶成任意体积、分给他人或按美国历史普通片换算。应按手中准确产品的现行说明书和专业指示核对。", "en": "Japanese OD identifies an orally disintegrating product; it does not permit arbitrary crushing, dissolving into an arbitrary volume, sharing or conversion from historical U.S. conventional tablets. Check the current label for the exact product and professional instruction." }, { "zh": "日本 100 mg 片有刻痕和 OG18 印字，刻痕首先是外观核对线索，不是所有人都能掰片或用半片拼规格的通用许可。50 mg、100 mg 和其他厂家产品必须分别核对。", "en": "The Japanese 100 mg tablet has a score and OG18 imprint. A score is first an appearance clue, not universal permission for everyone to split a tablet or assemble a strength from halves. Check 50 mg, 100 mg and other manufacturers' products separately." }, { "zh": "PMDA 当前文书和 FDA 历史标签都把充血性/任何程度心力衰竭列为重要禁忌边界。已有心衰、原因不明的气促、水肿、胸痛、明显心悸或晕厥者，不要靠网页自行开始、继续、加量或停药，应尽快联系负责团队；严重胸痛、呼吸困难或晕厥应使用当地急救服务。", "en": "The current PMDA document and historical FDA label identify congestive/any-severity heart failure as a major contraindication boundary. With known heart failure, unexplained breathlessness, swelling, chest pain, marked palpitations or fainting, do not use a webpage to start, continue, increase or stop the medicine; contact the responsible team promptly. Severe chest pain, breathing difficulty or fainting requires local emergency care." }, { "zh": "阿司匹林、氯吡格雷、普拉格雷、替格瑞洛、华法林、阿哌沙班、利伐沙班、达比加群、依度沙班及 NSAID 止痛药等同在药单时，是需要优先完整核对的出血线索。不要自行叠加、轮换、错开时间或停掉其中一种。", "en": "Aspirin, clopidogrel, prasugrel, ticagrelor, warfarin, apixaban, rivaroxaban, dabigatran, edoxaban or NSAID pain medicines on the same list are priority bleeding-review cues. Do not self-combine, alternate, time-separate or stop one of them." }, { "zh": "黑便、呕血、无法止住的出血、突然偏瘫/言语不清、严重头痛、意识变化或严重过敏表现可能是急症，应立即使用当地急救服务；不要等待网页或自行补服、停换药来观察。", "en": "Black stool, vomiting blood, uncontrolled bleeding, sudden weakness or speech trouble, severe headache, altered consciousness or severe allergy may be emergencies. Use local emergency services immediately; do not wait for a webpage or self-take, stop or switch medicine to observe." }, { "zh": "历史 FDA 标签提示多种 CYP3A4 或 CYP2C19 抑制药可能影响西洛他唑暴露，例子包括部分抗真菌药、抗菌药、维拉帕米/地尔硫卓、奥美拉唑及葡萄柚相关产品。这个来源线索不能改写成网页剂量表；请把所有处方药、非处方药、补充剂和饮食相关产品交给药师核对。", "en": "The historical FDA label indicates that several CYP3A4 or CYP2C19 inhibitors may affect cilostazol exposure, including some antifungals, antibacterials, verapamil/diltiazem, omeprazole and grapefruit-related products. This source cue must not become a web dose table; have a pharmacist review every prescription medicine, OTC product, supplement and relevant dietary product." } ], "source": { "id": "src_0f79cd93faca2cc7", "label": "日本 PMDA：プレタール OD 錠 50 mg / 100 mg 当前电子添付文书（2023-02 修订）", "url": "https://www.pmda.go.jp/PmdaSearch/iyakuDetail/ResultDataSetPDF/180078_3399002F3020_1_11", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_pdf", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "西洛他唑怎样起作用：PDE3 抑制和血小板线索不能变成换药规则", "en": "How cilostazol works: PDE3 inhibition and platelet effects are not switching rules" }, "summary": { "zh": "官方标签描述西洛他唑抑制磷酸二酯酶 III、增加细胞内 cAMP，并影响血小板聚集及血管反应。这帮助理解为什么要优先核对出血、心率、心衰和完整药单，但“抗血小板”不是与阿司匹林、氯吡格雷或抗凝药可自行互换、叠加或停换的同义词。", "en": "Official labels describe cilostazol as inhibiting phosphodiesterase III, increasing intracellular cAMP and affecting platelet aggregation and vascular responses. This helps explain why bleeding, heart rate, heart failure and the complete medicine list need priority review. ‘Antiplatelet’ does not make it interchangeable or self-combinable with aspirin, clopidogrel or an anticoagulant." }, "checks": [ { "zh": "作用机制不能判断某个人是否该用西洛他唑，也不能根据步行距离、腿痛、血压或心率数字生成片数、频率或疗程。", "en": "Mechanism cannot decide whether an individual should use cilostazol or generate tablet count, frequency or duration from walking distance, leg pain, blood pressure or heart rate." }, { "zh": "同为抗血小板或影响凝血的药，不表示作用路径、获批用途、出血风险和停换边界相同。请由负责团队按诊断、准确药盒、完整药单和计划中的操作/手术逐项核对。", "en": "Medicines that are antiplatelet or affect clotting do not share the same pathway, approved use, bleeding risk or stopping/switching boundary. The responsible team must review the diagnosis, exact packs, full medicine list and any planned procedure or surgery." }, { "zh": "心悸或心率变化不能靠机制解释后自行补服或停药；严重胸痛、呼吸困难、晕厥、卒中或大出血表现应立即使用当地急救服务。", "en": "Do not use a mechanism explanation to self-take an extra tablet or stop after palpitations or heart-rate changes. Severe chest pain, breathing difficulty, fainting, stroke features or major bleeding require immediate local emergency care." } ], "source": { "id": "src_9cf5753b3132af87", "label": "美国 FDA：PLETAL 西洛他唑 50 mg / 100 mg 历史标签（2017；不是当前标签）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020863s024lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_pdf", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "PLETAL / Pletaal", "generic": "西洛他唑", "dosageFormClass": "日本当前为 Pletaal OD 口崩片；美国档案为历史普通口服片。相同成分和毫克数不合并产品形态、包装或市场状态。" }, "labelSource": { "id": "src_0f79cd93faca2cc7", "label": "日本 PMDA：プレタール OD 錠 50 mg / 100 mg 当前电子添付文书（2023-02 修订）", "url": "https://www.pmda.go.jp/PmdaSearch/iyakuDetail/ResultDataSetPDF/180078_3399002F3020_1_11", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_pdf", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "productRoutes": [ { "source": { "id": "src_0f79cd93faca2cc7", "label": "日本 PMDA：プレタール OD 錠 50 mg / 100 mg 当前电子添付文书（2023-02 修订）", "url": "https://www.pmda.go.jp/PmdaSearch/iyakuDetail/ResultDataSetPDF/180078_3399002F3020_1_11", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_pdf", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "status": "product_level_public_record_verified", "authority": { "zh": "PMDA", "en": "PMDA" }, "market": { "zh": "日本", "en": "Japan" }, "recordType": { "zh": "监管产品记录", "en": "Regulatory product record" }, "reviewedAt": "2026-08-29", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_507aafb6e9d8b752", "label": "日本 PMDA：プレタール OD 錠 50 mg / 100 mg 当前专业用产品记录", "url": "https://www.pmda.go.jp/PmdaSearch/rdDetail/iyaku/3399002F3020_1?user=1", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "status": "product_level_public_record_verified", "authority": { "zh": "PMDA", "en": "PMDA" }, "market": { "zh": "日本", "en": "Japan" }, "recordType": { "zh": "监管产品记录", "en": "Regulatory product record" }, "reviewedAt": "2026-08-29", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_a771c1ffa05d2e9b", "label": "美国 FDA：PLETAL 西洛他唑 NDA 020863 原始批准信（1999-01-15）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/cilostazol_letter.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_pdf", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-08-29", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_9cf5753b3132af87", "label": "美国 FDA：PLETAL 西洛他唑 50 mg / 100 mg 历史标签（2017；不是当前标签）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020863s024lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_pdf", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-08-29", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_0aa10e476910ee8b", "label": "美国 FDA：PLETAL 西洛他唑 50 mg / 100 mg 历史标签与包装信息（2015；不是当前标签）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020863s022lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_pdf", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-08-29", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "PMDA", "en": "PMDA" }, "market": { "zh": "日本", "en": "Japan" }, "recordType": { "zh": "监管产品记录", "en": "Regulatory product record" }, "reviewedAt": "2026-08-29", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "PLETAL / Pletaal 是西洛他唑品牌档案。普通人首先要分清手中是日本 Pletaal OD 口崩片、美国历史 PLETAL 普通片，还是其他厂家西洛他唑；相同成分和 50/100 mg 不表示同一包装或可自行替换。西洛他唑会影响血小板聚集和血管反应；心力衰竭、胸痛/心悸、出血风险，以及与抗血小板药、抗凝药、止痛药和其他相互作用药同在药单时，都应优先让医生或药师核对完整药单与准确药盒。", "history": "美国 FDA 于 1999-01-15 批准 NDA 020863 的 Pletal 50 mg 与 100 mg 片。日本 PMDA 当前产品记录列示 Pletaal OD 50 mg（22100AMX02276）与 100 mg（22100AMX02275），电子添付文书修订于 2023-02；这两个日本口崩片产品不能用美国历史普通片包装替代展示。", "sourceDocuments": [ { "id": "src_507aafb6e9d8b752", "label": "日本 PMDA：プレタール OD 錠 50 mg / 100 mg 当前专业用产品记录", "url": "https://www.pmda.go.jp/PmdaSearch/rdDetail/iyaku/3399002F3020_1?user=1", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, { "id": "src_4f7aae23e8d8b5bf", "label": "日本 PMDA：プレタール OD 錠 50 mg / 100 mg 当前公众用产品记录", "url": "https://www.pmda.go.jp/PmdaSearch/rdDetail/iyaku/3399002F3020_1?user=2", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "consumer_medicine_information", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, { "id": "src_0f79cd93faca2cc7", "label": "日本 PMDA：プレタール OD 錠 50 mg / 100 mg 当前电子添付文书（2023-02 修订）", "url": "https://www.pmda.go.jp/PmdaSearch/iyakuDetail/ResultDataSetPDF/180078_3399002F3020_1_11", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_pdf", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, { "id": "src_af01f4636e5e5e87", "label": "日本 PMDA：プレタール OD 錠 50 mg / 100 mg 患者向医药品指南（2022-10 更新）", "url": "https://www.info.pmda.go.jp/downfiles/ph/GUI/180078_3399002F3020_1_02G.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "consumer_medicine_information", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_pdf", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, { "id": "src_a771c1ffa05d2e9b", "label": "美国 FDA：PLETAL 西洛他唑 NDA 020863 原始批准信（1999-01-15）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/cilostazol_letter.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_pdf", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, { "id": "src_9cf5753b3132af87", "label": "美国 FDA：PLETAL 西洛他唑 50 mg / 100 mg 历史标签（2017；不是当前标签）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020863s024lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_pdf", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, { "id": "src_0aa10e476910ee8b", "label": "美国 FDA：PLETAL 西洛他唑 50 mg / 100 mg 历史标签与包装信息（2015；不是当前标签）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020863s022lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_pdf", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } ], "applicationNumber": "美国 NDA 020863；日本 22100AMX02276 / 22100AMX02275", "approvalTimeline": [ { "date": "1999-01-15", "title": { "zh": "美国 FDA 原始批准", "en": "Original U.S. FDA approval" }, "detail": { "zh": "FDA 批准信将 Pletal 50 mg 与 100 mg 片、NDA 020863 和 Otsuka 对应。该历史节点不证明 2026 年美国当前标签或供应。", "en": "The FDA letter connects Pletal 50 mg and 100 mg tablets, NDA 020863 and Otsuka. This historical node does not establish a current 2026 U.S. label or supply." }, "source": { "id": "src_a771c1ffa05d2e9b", "label": "美国 FDA：PLETAL 西洛他唑 NDA 020863 原始批准信（1999-01-15）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/cilostazol_letter.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_pdf", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } }, { "date": "2010-04", "title": { "zh": "日本 Pletaal OD 片销售起始节点", "en": "Japanese Pletaal OD sales-start node" }, "detail": { "zh": "PMDA 当前电子添付文书列示 50 mg 与 100 mg OD 片的销售起始月份为 2010-04；不据此推定药房库存。", "en": "The current PMDA electronic label lists Apr 2010 as the sales-start month for 50 mg and 100 mg OD tablets; this does not establish pharmacy stock." }, "source": { "id": "src_0f79cd93faca2cc7", "label": "日本 PMDA：プレタール OD 錠 50 mg / 100 mg 当前电子添付文书（2023-02 修订）", "url": "https://www.pmda.go.jp/PmdaSearch/iyakuDetail/ResultDataSetPDF/180078_3399002F3020_1_11", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_pdf", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } }, { "date": "2023-02", "title": { "zh": "日本当前电子添付文书修订节点", "en": "Current Japanese electronic-label revision" }, "detail": { "zh": "页面以此当前 PMDA 文书为日本标签入口，并另提供 2022-10 患者指南。", "en": "The page uses this current PMDA document as the Japanese label entry point and separately links the Oct 2022 patient guide." }, "source": { "id": "src_0f79cd93faca2cc7", "label": "日本 PMDA：プレタール OD 錠 50 mg / 100 mg 当前电子添付文书（2023-02 修订）", "url": "https://www.pmda.go.jp/PmdaSearch/iyakuDetail/ResultDataSetPDF/180078_3399002F3020_1_11", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_pdf", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } } ], "marketStatus": [ { "market": { "zh": "日本", "en": "Japan" }, "status": { "zh": "Pletaal OD 50 mg / 100 mg 当前 PMDA 记录已链接", "en": "Current PMDA records linked for Pletaal OD 50 mg / 100 mg" }, "detail": { "zh": "监管记录不等于具体库存、购买资格、个人适用性或可自行换药。", "en": "A regulatory record does not establish stock, purchasing eligibility, individual suitability or self-switching." } }, { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "1999 批准及 2015/2017 历史档案已链接；当前状态未建立", "en": "1999 approval and 2015/2017 historical archives linked; current status not established" }, "detail": { "zh": "历史标签中的 60 片瓶装 NDC 仅用于档案身份，不声称当前销售或供应。", "en": "The 60-tablet bottle NDCs in historical labels are archival identities only and do not claim current marketing or supply." } }, { "market": { "zh": "中国大陆、欧盟及其他市场", "en": "Mainland China, EU and other markets" }, "status": { "zh": "待逐项建立现行市场记录", "en": "Current market record not established" }, "detail": { "zh": "不从日本或美国资料外推当地品牌、批准、包装、供应、原研/仿制关系或可替代性。", "en": "No local brand, approval, pack, supply, originator/generic relationship or interchangeability is inferred from Japanese or U.S. documents." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "Pletaal OD 和 PLETAL 普通片是同一包装吗？", "en": "Are Pletaal OD and conventional PLETAL the same pack?" }, "answer": { "zh": "不是。本页日本当前记录是口崩片，美国资料是历史普通片；名称和毫克数接近也不能合并剂型、包装、市场状态或自行换药。", "en": "No. The current Japanese record is an orally disintegrating tablet, while the U.S. sources describe historical conventional tablets. Similar names and milligram numbers do not merge dosage form, pack, market status or permit self-switching." } }, { "question": { "zh": "100 mg 片有刻痕，能自己掰成 50 mg 吗？", "en": "Can a scored 100 mg tablet be self-split into 50 mg?" }, "answer": { "zh": "网页不能这样判断。刻痕是产品外观线索，不是通用分片或换算许可；应按手中准确产品的现行说明书、处方和药师/开方团队指示核对。", "en": "A webpage cannot make that decision. A score is a product-appearance clue, not universal splitting or conversion permission; check the current label, prescription and professional instruction for the exact product." } }, { "question": { "zh": "正在用阿司匹林或抗凝药，可以加西洛他唑吗？", "en": "Can cilostazol be added to aspirin or an anticoagulant?" }, "answer": { "zh": "不能由网页决定，也不要自行添加、停用或错开。请把所有处方药、非处方止痛药、补充剂和实际药盒交给负责团队核对出血风险、用途与监测计划。", "en": "A webpage cannot decide this. Do not self-add, stop or time-separate. Have the responsible team review every prescription medicine, OTC pain product, supplement and actual pack for bleeding risk, purpose and monitoring." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "dosage-forms-are-part-of-medicine-identity", "how-to-read-a-drug-label" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/pletal/", "en": "https://origindrug.com/en/drugs/pletal/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "zofran", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-29", "status": "published_traceable_archive" }, "names": { "brand": "ZOFRAN / ZOFRAN ODT", "generic": "昂丹司琼", "aliases": [ "Zofran", "ZOFRAN ODT", "ondansetron", "ondansetron hydrochloride", "昂丹司琼", "盐酸昂丹司琼", "昂丹司琼片", "昂丹司琼口崩片", "昂丹司琼口服液", "NDA 020103", "NDA 020605", "NDA 020781", "4 mg/5 mL" ], "marketBrandNames": [ { "name": "ZOFRAN / ZOFRAN ODT", "market": { "zh": "美国", "en": "United States" }, "evidenceStatus": "current_approved_label_with_discontinued_product_records", "note": { "zh": "2025 当前批准标签可读；六个 Orange Book 口服 RLD 产品当前列为 Discontinued，不能据此推定库存。", "en": "The current 2025 approved label is readable; six oral Orange Book RLD products are currently listed as Discontinued, which does not establish stock." }, "source": { "id": "src_51c6c158a6917fbc", "label": "美国 FDA：ZOFRAN 昂丹司琼片、口崩片与口服液当前批准标签（2025-02 修订）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/020103s039%2C020605s023%2C020781s023lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_pdf", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } } ], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "消化系统", "sourceArchiveMarket": "美国：FDA 2025-02 当前批准标签覆盖 ZOFRAN 4/8 mg 普通片、4/8 mg 口崩片及 4 mg/5 mL 口服液；FDA Orange Book 当前数据另记录 NDA 020103、020781 与 020605 的六个口服 RLD 产品均为 Discontinued、RS 为 No，并保留‘并非因安全性或有效性原因停止销售或撤市’的联邦公报判定。当前标签可阅读不等于这些历史产品目前有货、可购买或可替代。", "dosageFormClass": "普通口服片、口崩片与 4 mg/5 mL 口服液必须分开识别；24 mg 普通片是 Orange Book 历史产品身份，未列入 2025 当前标签的供应剂型与强度清单", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "1991（美国首次批准）；1992–1999（本页六个口服产品身份）", "archiveSponsorText": "Sandoz Inc.（FDA 当前标签与 Orange Book 申请主体）；GlaxoSmithKline 为历史开发／标签主体" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [ "ondansetron injection", "ondansetron premixed injection", "昂丹司琼注射液", "generic ondansetron", "其他厂牌昂丹司琼", "apomorphine", "granisetron", "palonosetron" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-zofran-ondansetron-conventional-tablet-4mg-nda-020103-product-001-discontinued-rld", "marketCode": "US", "labelVersion": { "zh": "FDA Orange Book 当前产品身份数据（2026-08-29 核验）；并与 2025-02 当前批准标签分开阅读", "en": "Current FDA Orange Book product-identity data (checked 29 Aug 2026), read separately from the current approved label revised Feb 2025" }, "dosageForm": { "zh": "ZOFRAN 昂丹司琼普通口服片（历史 RLD）", "en": "ZOFRAN ondansetron conventional oral tablet (historical RLD)" }, "route": { "zh": "口服（历史监管产品身份字段）", "en": "oral (historical regulatory product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDA 020103 / Product 001", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片昂丹司琼 4 mg；历史 RLD，Orange Book 当前列为 Discontinued", "en": "Ondansetron 4 mg per tablet; historical RLD currently listed as Discontinued in the Orange Book" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "昂丹司琼（以盐酸昂丹司琼二水合物提供）", "en": "ondansetron (as ondansetron hydrochloride dihydrate)" }, "value": 4, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片监管标示量；不是个人片数、频率或换算指令", "en": "regulatory amount per tablet; not an individual's tablet count, frequency or conversion instruction" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-29", "currentLabelDisplayed": true, "ndcDirectoryListed": false, "marketAvailability": "orange_book_discontinued_product", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": null, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_10e511bf83430e3b", "label": "美国 FDA Orange Book 当前数据：ZOFRAN 六个口服 RLD 产品与停止销售状态", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-zofran-ondansetron-conventional-tablet-8mg-nda-020103-product-002-discontinued-rld", "marketCode": "US", "labelVersion": { "zh": "FDA Orange Book 当前产品身份数据（2026-08-29 核验）；并与 2025-02 当前批准标签分开阅读", "en": "Current FDA Orange Book product-identity data (checked 29 Aug 2026), read separately from the current approved label revised Feb 2025" }, "dosageForm": { "zh": "ZOFRAN 昂丹司琼普通口服片（历史 RLD）", "en": "ZOFRAN ondansetron conventional oral tablet (historical RLD)" }, "route": { "zh": "口服（历史监管产品身份字段）", "en": "oral (historical regulatory product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDA 020103 / Product 002", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片昂丹司琼 8 mg；历史 RLD，Orange Book 当前列为 Discontinued", "en": "Ondansetron 8 mg per tablet; historical RLD currently listed as Discontinued in the Orange Book" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "昂丹司琼（以盐酸昂丹司琼二水合物提供）", "en": "ondansetron (as ondansetron hydrochloride dihydrate)" }, "value": 8, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片监管标示量；不是个人片数、频率或换算指令", "en": "regulatory amount per tablet; not an individual's tablet count, frequency or conversion instruction" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-29", "currentLabelDisplayed": true, "ndcDirectoryListed": false, "marketAvailability": "orange_book_discontinued_product", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": null, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_10e511bf83430e3b", "label": "美国 FDA Orange Book 当前数据：ZOFRAN 六个口服 RLD 产品与停止销售状态", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-zofran-ondansetron-conventional-tablet-24mg-nda-020103-product-003-discontinued-rld", "marketCode": "US", "labelVersion": { "zh": "FDA Orange Book 当前产品身份数据（2026-08-29 核验）；并与 2025-02 当前批准标签分开阅读", "en": "Current FDA Orange Book product-identity data (checked 29 Aug 2026), read separately from the current approved label revised Feb 2025" }, "dosageForm": { "zh": "ZOFRAN 昂丹司琼普通口服片（历史 RLD）", "en": "ZOFRAN ondansetron conventional oral tablet (historical RLD)" }, "route": { "zh": "口服（历史监管产品身份字段）", "en": "oral (historical regulatory product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDA 020103 / Product 003", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片昂丹司琼 24 mg；历史 RLD，Orange Book 当前列为 Discontinued", "en": "Ondansetron 24 mg per tablet; historical RLD currently listed as Discontinued in the Orange Book" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "昂丹司琼（以盐酸昂丹司琼二水合物提供）", "en": "ondansetron (as ondansetron hydrochloride dihydrate)" }, "value": 24, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片监管标示量；不是个人片数、频率或换算指令", "en": "regulatory amount per tablet; not an individual's tablet count, frequency or conversion instruction" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-29", "currentLabelDisplayed": false, "ndcDirectoryListed": false, "marketAvailability": "orange_book_discontinued_product", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": null, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_10e511bf83430e3b", "label": "美国 FDA Orange Book 当前数据：ZOFRAN 六个口服 RLD 产品与停止销售状态", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-zofran-odt-ondansetron-orally-disintegrating-tablet-4mg-nda-020781-product-001-discontinued-rld", "marketCode": "US", "labelVersion": { "zh": "FDA Orange Book 当前产品身份数据（2026-08-29 核验）；2025-02 当前批准标签仍列示该剂型和强度", "en": "Current FDA Orange Book product-identity data (checked 29 Aug 2026); the current approved label revised Feb 2025 still lists this form and strength" }, "dosageForm": { "zh": "ZOFRAN ODT 昂丹司琼口崩片（历史 RLD）", "en": "ZOFRAN ODT ondansetron orally disintegrating tablet (historical RLD)" }, "route": { "zh": "口服／舌上崩解（历史监管产品身份字段）", "en": "oral / disintegrates on the tongue (historical regulatory product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDA 020781 / Product 001", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片昂丹司琼 4 mg；口崩片历史 RLD，Orange Book 当前列为 Discontinued", "en": "Ondansetron 4 mg per orally disintegrating tablet; historical RLD currently listed as Discontinued in the Orange Book" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "昂丹司琼（以盐酸昂丹司琼二水合物提供）", "en": "ondansetron (as ondansetron hydrochloride dihydrate)" }, "value": 4, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片监管标示量；不是个人片数、频率、吞服方式或换算指令", "en": "regulatory amount per tablet; not an individual's tablet count, frequency, administration or conversion instruction" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-29", "currentLabelDisplayed": true, "ndcDirectoryListed": false, "marketAvailability": "orange_book_discontinued_product", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": null, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_10e511bf83430e3b", "label": "美国 FDA Orange Book 当前数据：ZOFRAN 六个口服 RLD 产品与停止销售状态", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-zofran-odt-ondansetron-orally-disintegrating-tablet-8mg-nda-020781-product-002-discontinued-rld", "marketCode": "US", "labelVersion": { "zh": "FDA Orange Book 当前产品身份数据（2026-08-29 核验）；2025-02 当前批准标签仍列示该剂型和强度", "en": "Current FDA Orange Book product-identity data (checked 29 Aug 2026); the current approved label revised Feb 2025 still lists this form and strength" }, "dosageForm": { "zh": "ZOFRAN ODT 昂丹司琼口崩片（历史 RLD）", "en": "ZOFRAN ODT ondansetron orally disintegrating tablet (historical RLD)" }, "route": { "zh": "口服／舌上崩解（历史监管产品身份字段）", "en": "oral / disintegrates on the tongue (historical regulatory product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDA 020781 / Product 002", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片昂丹司琼 8 mg；口崩片历史 RLD，Orange Book 当前列为 Discontinued", "en": "Ondansetron 8 mg per orally disintegrating tablet; historical RLD currently listed as Discontinued in the Orange Book" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "昂丹司琼（以盐酸昂丹司琼二水合物提供）", "en": "ondansetron (as ondansetron hydrochloride dihydrate)" }, "value": 8, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片监管标示量；不是个人片数、频率、吞服方式或换算指令", "en": "regulatory amount per tablet; not an individual's tablet count, frequency, administration or conversion instruction" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-29", "currentLabelDisplayed": true, "ndcDirectoryListed": false, "marketAvailability": "orange_book_discontinued_product", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": null, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_10e511bf83430e3b", "label": "美国 FDA Orange Book 当前数据：ZOFRAN 六个口服 RLD 产品与停止销售状态", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-zofran-ondansetron-oral-solution-4mg-per-5ml-nda-020605-product-001-discontinued-rld", "marketCode": "US", "labelVersion": { "zh": "FDA Orange Book 当前产品身份数据（2026-08-29 核验）；2025-02 当前批准标签仍列示 4 mg/5 mL", "en": "Current FDA Orange Book product-identity data (checked 29 Aug 2026); the current approved label revised Feb 2025 still lists 4 mg/5 mL" }, "dosageForm": { "zh": "ZOFRAN 昂丹司琼口服液（历史 RLD）", "en": "ZOFRAN ondansetron oral solution (historical RLD)" }, "route": { "zh": "口服（历史监管产品身份字段）", "en": "oral (historical regulatory product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDA 020605 / Product 001", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_5_mL", "primaryDisplay": { "zh": "每 5 mL 含昂丹司琼 4 mg；这是浓度，不是个人毫升数", "en": "Ondansetron 4 mg per 5 mL; this is a concentration, not an individual's millilitres" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "昂丹司琼（以盐酸昂丹司琼二水合物提供）", "en": "ondansetron (as ondansetron hydrochloride dihydrate)" }, "value": 4, "unit": "mg", "basisCode": "per_5_mL", "basisLabel": { "zh": "每 5 mL 监管标示浓度；不是个人毫升数、频率或疗程", "en": "regulatory concentration per 5 mL; not an individual's millilitres, frequency or course" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-29", "currentLabelDisplayed": true, "ndcDirectoryListed": false, "marketAvailability": "orange_book_discontinued_product", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": null, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_10e511bf83430e3b", "label": "美国 FDA Orange Book 当前数据：ZOFRAN 六个口服 RLD 产品与停止销售状态", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "status": "withheld_repackaged_or_non_exact_visual", "title": { "zh": "六个官方文字产品身份已建立；暂无逐一匹配的准确公开包装主图", "en": "Six official text product identities are established; exact public principal-display images are not yet mapped one-to-one" }, "summary": { "zh": "Orange Book 可核对三个 NDA、六个产品号、剂型、强度、RLD 与停止销售状态，但本轮官方来源未提供可安全复用并与六个身份逐一对应的准确原品牌包装主图。页面因此保留图片缺口，不用仿制药、零售图、注射剂或另一剂型包装代替。", "en": "The Orange Book verifies three NDAs, six product numbers, forms, strengths, RLD identity and discontinued status, but the reviewed official sources do not supply safely reusable exact originator-brand principal-display images mapped one-to-one to all six identities. The page discloses the image gap and does not substitute a generic, retail image, injection or another dosage form." }, "source": { "id": "src_10e511bf83430e3b", "label": "美国 FDA Orange Book 当前数据：ZOFRAN 六个口服 RLD 产品与停止销售状态", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "ZOFRAN 说明书放大阅读：先分清普通片、口崩片、口服液与完整药单风险", "en": "ZOFRAN label reading: distinguish conventional tablets, ODTs, oral solution and full-list risks first" }, "summary": { "zh": "2025 FDA 标签覆盖普通片、口崩片与 4 mg/5 mL 口服液。页面只把产品身份、取片方法和需优先核对的风险放大，不决定个人是否使用，也不生成片数、毫升数、频率、补服、开始、停用或疗程。", "en": "The 2025 FDA label covers conventional tablets, orally disintegrating tablets and 4 mg/5 mL oral solution. This page enlarges product identity, handling and priority review cues; it does not decide individual use or generate tablet count, millilitres, frequency, missed-use action, initiation, stopping or course." }, "checks": [ { "zh": "普通片和口崩片都可能写 4 mg 或 8 mg，但剂型与取用方式不同。ZOFRAN ODT 应留在泡罩内直至使用，以干手撕开背膜、轻取药片，不要把脆片从箔面硬推出来；随后立即放在舌上崩解。这个说明不是个人频率或是否可换剂型的依据。", "en": "Conventional tablets and ODTs may both say 4 mg or 8 mg, but their dosage form and handling differ. Keep ZOFRAN ODT in its blister until use, peel back the foil with dry hands, gently remove it rather than push the fragile tablet through the foil, and place it on the tongue immediately to dissolve. This is not an individual frequency or dosage-form switching rule." }, { "zh": "ZOFRAN ODT 含阿斯巴甜并提供少量苯丙氨酸。苯丙酮尿症患者或照护者应核对准确剂型和现行标签；普通片或口服液信息不能替代口崩片的这一成分提示。", "en": "ZOFRAN ODT contains aspartame and supplies a small amount of phenylalanine. A person with phenylketonuria or a caregiver should verify the exact form and current label; conventional-tablet or solution information does not replace this ODT ingredient warning." }, { "zh": "标签提示 QT 间期延长风险。先天性长 QT 综合征者应避免使用；低钾或低镁、充血性心力衰竭、缓慢性心律失常，或同用其他延长 QT 的药时需要专业核对，标签可能要求心电图监测。不要凭网页自行加减、错开或停掉任何药。", "en": "The label warns about QT prolongation. Avoid use in congenital long-QT syndrome; low potassium or magnesium, congestive heart failure, bradyarrhythmia or another QT-prolonging medicine requires professional review and the label may call for ECG monitoring. Do not add, reduce, separate or stop any medicine from this page." }, { "zh": "与影响血清素的药同用可能出现血清素综合征，相关药物可包括部分 SSRI、SNRI、其他抗抑郁药、曲普坦、曲马多、锂盐、芬太尼、圣约翰草等。躁动、意识变化、心跳快、血压波动、发热、多汗、震颤、肌肉僵硬或腹泻等组合表现需要立即医疗评估；严重时使用当地急救服务。", "en": "Serotonin syndrome may occur with serotonergic medicines, including some SSRIs, SNRIs, other antidepressants, triptans, tramadol, lithium, fentanyl and St John's wort. A combination of agitation, mental-status change, rapid heartbeat, blood-pressure change, fever, sweating, tremor, muscle rigidity or diarrhoea needs immediate medical assessment; use local emergency services if severe." }, { "zh": "阿扑吗啡与昂丹司琼合用属于标签禁忌，曾报告严重低血压和意识丧失。若两者都在药单，不要自行尝试、错开或停换药，应立即联系开方团队或药师核对。", "en": "Apomorphine with ondansetron is contraindicated in the label because profound hypotension and loss of consciousness have been reported. If both appear on the medicine list, do not self-try, separate or stop/switch them; contact the prescriber or pharmacist promptly." }, { "zh": "严重胸痛、呼吸困难、晕厥或心律异常可能需要急救；持续便秘、腹胀、呕吐或疑似肠梗阻也需要尽快评估，因为昂丹司琼可能掩盖进行性肠梗阻或胃扩张。网页不判断症状原因，也不安排个人用药。", "en": "Severe chest pain, breathing difficulty, fainting or an abnormal rhythm may require emergency care. Persistent constipation, abdominal distension, vomiting or suspected obstruction also needs prompt assessment because ondansetron may mask progressive ileus or gastric distension. The site does not diagnose the cause or arrange individual use." }, { "zh": "口服液 4 mg/5 mL 是浓度，不表示每个人都使用 5 mL。个人毫升数、量具、频率与疗程必须来自准确处方和药房标签；普通厨房勺不是可靠量具。", "en": "Oral solution 4 mg/5 mL is a concentration and does not mean everyone uses 5 mL. Individual millilitres, measuring device, frequency and course must come from the exact prescription and pharmacy label; an ordinary kitchen spoon is not a reliable measure." } ], "source": { "id": "src_51c6c158a6917fbc", "label": "美国 FDA：ZOFRAN 昂丹司琼片、口崩片与口服液当前批准标签（2025-02 修订）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/020103s039%2C020605s023%2C020781s023lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_pdf", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "昂丹司琼怎样起作用：5-HT3 受体拮抗不能变成个人选药或换药规则", "en": "How ondansetron works: 5-HT3 receptor antagonism is not an individual selection or switching rule" }, "summary": { "zh": "官方标签将昂丹司琼描述为选择性 5-HT3 受体拮抗剂，用于解释其止吐相关药理路径。机制不判断恶心或呕吐的原因，也不能推导个人是否适用、服几片或多少毫升、如何与其他止吐药合用。", "en": "The official label describes ondansetron as a selective 5-HT3 receptor antagonist, explaining an antiemetic pharmacologic pathway. Mechanism does not diagnose the cause of nausea or vomiting or derive individual suitability, tablet count, millilitres or combination with another antiemetic." }, "checks": [ { "zh": "止吐药类别不能替代对脱水、感染、肠梗阻、药物不良反应、心脏问题或其他原因的评估；持续或严重症状应使用当地医疗支持。", "en": "An antiemetic class cannot replace assessment for dehydration, infection, obstruction, adverse drug effects, cardiac problems or another cause; persistent or severe symptoms need local medical support." }, { "zh": "同为止吐药或同样影响血清素，不表示可以与甲氧氯普胺、其他 5-HT3 拮抗剂或精神科药物自行叠加、替换或按毫克换算。", "en": "Being an antiemetic or affecting serotonin does not make it self-combinable, substitutable or milligram-convertible with metoclopramide, another 5-HT3 antagonist or a psychiatric medicine." }, { "zh": "作用机制不能消除 QT、血清素综合征、阿扑吗啡禁忌或肠梗阻掩盖等标签风险；完整药单、准确产品和实际症状必须一并核对。", "en": "Mechanism does not remove the labelled risks of QT prolongation, serotonin syndrome, the apomorphine contraindication or masking obstruction; the complete medicine list, exact product and actual symptoms must be reviewed together." } ], "source": { "id": "src_51c6c158a6917fbc", "label": "美国 FDA：ZOFRAN 昂丹司琼片、口崩片与口服液当前批准标签（2025-02 修订）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/020103s039%2C020605s023%2C020781s023lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_pdf", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "ZOFRAN / ZOFRAN ODT", "generic": "昂丹司琼", "dosageFormClass": "普通口服片、口崩片与 4 mg/5 mL 口服液必须分开识别；24 mg 普通片是 Orange Book 历史产品身份，未列入 2025 当前标签的供应剂型与强度清单" }, "labelSource": { "id": "src_51c6c158a6917fbc", "label": "美国 FDA：ZOFRAN 昂丹司琼片、口崩片与口服液当前批准标签（2025-02 修订）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/020103s039%2C020605s023%2C020781s023lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_pdf", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "productRoutes": [ { "source": { "id": "src_51c6c158a6917fbc", "label": "美国 FDA：ZOFRAN 昂丹司琼片、口崩片与口服液当前批准标签（2025-02 修订）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/020103s039%2C020605s023%2C020781s023lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_pdf", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-08-29", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_10e511bf83430e3b", "label": "美国 FDA Orange Book 当前数据：ZOFRAN 六个口服 RLD 产品与停止销售状态", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-08-29", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_0aefe4de9e004d2a", "label": "美国 FDA：ZOFRAN 片、口崩片与口服液历史批准标签（2016）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020103s035_020605s019_020781s019lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_pdf", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-08-29", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-08-29", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "ZOFRAN / ZOFRAN ODT 是昂丹司琼品牌档案。普通片、口崩片和 4 mg/5 mL 口服液虽然成分相同，却不是凭数字就能自行互换的同一产品；口崩片还涉及泡罩取片和苯丙酮尿症所需的苯丙氨酸核对。若药单有影响 QT 间期、血清素或电解质的药，或使用阿扑吗啡，应先让医生或药师核对完整药单。网页不提供个人片数、毫升数、频率或疗程。", "history": "FDA 当前标签列示 ZOFRAN 于 1991 年首次在美国批准。Orange Book 记录普通片 4/8 mg 于 1992-12-31、口服液 4 mg/5 mL 于 1997-01-24、口崩片 4/8 mg 于 1999-01-27、普通片 24 mg 于 1999-08-27 获批。2025-02 的当前批准标签仍可阅读；2026-08-29 核验的 Orange Book 将六个具体口服 RLD 产品均列为 Discontinued，并保留并非因安全性或有效性原因撤市的判定。", "sourceDocuments": [ { "id": "src_51c6c158a6917fbc", "label": "美国 FDA：ZOFRAN 昂丹司琼片、口崩片与口服液当前批准标签（2025-02 修订）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/020103s039%2C020605s023%2C020781s023lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_pdf", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, { "id": "src_10e511bf83430e3b", "label": "美国 FDA Orange Book 当前数据：ZOFRAN 六个口服 RLD 产品与停止销售状态", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, { "id": "src_0aefe4de9e004d2a", "label": "美国 FDA：ZOFRAN 片、口崩片与口服液历史批准标签（2016）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020103s035_020605s019_020781s019lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_pdf", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } ], "applicationNumber": "FDA NDA 020103（普通片）／NDA 020605（口服液）／NDA 020781（口崩片）", "approvalTimeline": [ { "date": "1991", "title": { "zh": "ZOFRAN 美国首次批准节点", "en": "Initial U.S. ZOFRAN approval milestone" }, "detail": { "zh": "FDA 2025 当前标签把 1991 年列为 ZOFRAN 美国首次批准年份；本档案的产品卡仅覆盖后续六个口服身份。", "en": "The current 2025 FDA label lists 1991 as the initial U.S. approval year; this dossier's product cards cover only the six later oral identities." }, "source": { "id": "src_51c6c158a6917fbc", "label": "美国 FDA：ZOFRAN 昂丹司琼片、口崩片与口服液当前批准标签（2025-02 修订）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/020103s039%2C020605s023%2C020781s023lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_pdf", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } }, { "date": "1992-12-31", "title": { "zh": "ZOFRAN 4 mg 与 8 mg 普通片", "en": "ZOFRAN 4 mg and 8 mg conventional tablets" }, "detail": { "zh": "Orange Book 将 NDA 020103 产品 001 与 002 列为 RLD；当前产品状态为 Discontinued。", "en": "The Orange Book lists NDA 020103 products 001 and 002 as RLDs; their current product status is Discontinued." }, "source": { "id": "src_10e511bf83430e3b", "label": "美国 FDA Orange Book 当前数据：ZOFRAN 六个口服 RLD 产品与停止销售状态", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } }, { "date": "1997-01-24", "title": { "zh": "ZOFRAN 4 mg/5 mL 口服液", "en": "ZOFRAN 4 mg/5 mL oral solution" }, "detail": { "zh": "Orange Book 将 NDA 020605 产品 001 列为 RLD；当前产品状态为 Discontinued。", "en": "The Orange Book lists NDA 020605 product 001 as an RLD; its current product status is Discontinued." }, "source": { "id": "src_10e511bf83430e3b", "label": "美国 FDA Orange Book 当前数据：ZOFRAN 六个口服 RLD 产品与停止销售状态", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } }, { "date": "1999", "title": { "zh": "ZOFRAN ODT 与 24 mg 历史普通片", "en": "ZOFRAN ODT and the historical 24 mg conventional tablet" }, "detail": { "zh": "4/8 mg 口崩片于 1999-01-27 获批，24 mg 普通片于 1999-08-27 获批。三者当前均列为 Discontinued；24 mg 未列入 2025 当前标签的供应剂型与强度清单。", "en": "The 4/8 mg ODTs were approved on 27 Jan 1999 and the 24 mg conventional tablet on 27 Aug 1999. All three are currently listed as Discontinued; 24 mg is not in the current 2025 label's available dosage-form and strength list." }, "source": { "id": "src_10e511bf83430e3b", "label": "美国 FDA Orange Book 当前数据：ZOFRAN 六个口服 RLD 产品与停止销售状态", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } }, { "date": "2025-02", "title": { "zh": "当前批准口服标签修订", "en": "Current approved oral label revised" }, "detail": { "zh": "当前 FDA 标签可阅读普通片 4/8 mg、口崩片 4/8 mg 与口服液 4 mg/5 mL 的产品信息和安全边界。标签可读不表示六个历史 RLD 产品当前供应。", "en": "The current FDA label provides product information and safety boundaries for 4/8 mg conventional tablets, 4/8 mg ODTs and 4 mg/5 mL oral solution. A readable label does not establish current supply of the six historical RLD products." }, "source": { "id": "src_51c6c158a6917fbc", "label": "美国 FDA：ZOFRAN 昂丹司琼片、口崩片与口服液当前批准标签（2025-02 修订）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/020103s039%2C020605s023%2C020781s023lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_pdf", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } }, { "date": "2026-08-29", "title": { "zh": "Orange Book 状态核验", "en": "Orange Book status reviewed" }, "detail": { "zh": "六个口服产品均为 RLD、RS 为 No、当前列为 Discontinued；数据保留并非因安全性或有效性原因停止销售或撤市的判定。", "en": "All six oral products are RLDs, RS No and currently listed as Discontinued; the data retain the determination that they were not discontinued or withdrawn for safety or effectiveness reasons." }, "source": { "id": "src_10e511bf83430e3b", "label": "美国 FDA Orange Book 当前数据：ZOFRAN 六个口服 RLD 产品与停止销售状态", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "2025 当前批准标签可读；六个具体口服 RLD 产品当前列为 Discontinued", "en": "Current 2025 approved label readable; six specific oral RLD products currently listed as Discontinued" }, "detail": { "zh": "这两个状态必须分开理解；不据此推定库存、购买渠道、个人适用性或可替代性。", "en": "These states must be read separately and do not establish stock, a purchasing channel, individual suitability or interchangeability." } }, { "market": { "zh": "中国大陆及其他市场", "en": "Mainland China and other markets" }, "status": { "zh": "待逐项建立现行市场记录", "en": "Current market record not established" }, "detail": { "zh": "不从美国品牌、共同成分或毫克数推定当地批准、商品名、包装、供应、原研／仿制关系或可替代性。", "en": "No local approval, trade name, pack, supply, originator/generic relationship or interchangeability is inferred from the U.S. brand, shared ingredient or milligram numbers." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "ZOFRAN ODT 和普通片都是 4 mg，可以直接互换吗？", "en": "Can a 4 mg ZOFRAN ODT and a 4 mg conventional tablet be directly interchanged?" }, "answer": { "zh": "不能仅凭相同成分和毫克数自行换。它们是不同剂型，取用方式和辅料提示不同；应核对准确处方、手中产品及当地现行标签，并让药师或开方团队确认。", "en": "Do not self-switch from the shared ingredient and milligram number. They are different dosage forms with different handling and excipient cues; verify the exact prescription, product in hand and current local label with a pharmacist or prescriber." } }, { "question": { "zh": "口服液写 4 mg/5 mL，是否每次都喝 5 mL？", "en": "Does oral solution 4 mg/5 mL mean taking 5 mL every time?" }, "answer": { "zh": "不是。4 mg/5 mL 是浓度，不是个人剂量。个人毫升数、频率和疗程必须来自准确处方和药房标签，并用合适的口服量具。", "en": "No. 4 mg/5 mL is a concentration, not an individual dose. Individual millilitres, frequency and course must come from the exact prescription and pharmacy label and be measured with a suitable oral device." } }, { "question": { "zh": "我同时使用抗抑郁药或影响心律的药，网页能判断是否能一起用吗？", "en": "Can the site decide whether ZOFRAN can be used with my antidepressant or rhythm-affecting medicine?" }, "answer": { "zh": "不能。昂丹司琼标签涉及血清素综合征和 QT 间期风险，判断需要准确药名、剂型、处方原因、疾病、电解质和完整药单。请让医生或药师逐项核对；严重症状使用当地急救服务。", "en": "No. The ondansetron label includes serotonin-syndrome and QT-prolongation risks. Review requires exact names/forms, reasons, conditions, electrolytes and the full list. Ask a clinician or pharmacist to review each item; use local emergency services for severe symptoms." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "dosage-forms-are-part-of-medicine-identity", "polypharmacy-safety-guide" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/zofran/", "en": "https://origindrug.com/en/drugs/zofran/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "miralax", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-29", "status": "published_traceable_archive" }, "names": { "brand": "MiraLAX", "generic": "聚乙二醇 3350", "aliases": [ "MIRALAX", "Miralax", "polyethylene glycol 3350", "PEG 3350", "PEG3350", "聚乙二醇 3350", "聚乙二醇3350散", "聚乙二醇 3350 粉末", "NDA 022015", "11523-7268-3", "11523-7268-9", "11523-7234-4", "11523-4357-3" ], "marketBrandNames": [ { "name": "MiraLAX", "market": { "zh": "美国", "en": "United States" }, "evidenceStatus": "current_regulatory_record", "note": { "zh": "FDA 当前列示 17 g/标线量盖与 17 g/袋两个 RLD/RS OTC 产品；准确包装仍须按 NDC 和当前标签核对。", "en": "FDA currently lists 17 g per marked-cap fill and 17 g per packet as RLD/RS OTC products; exact packs still require NDC and current-label checking." }, "source": { "id": "src_22a857a6b43afae2", "label": "FDA Drugs@FDA：MiraLAX NDA 022015 当前产品、RLD 与批准历史", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=022015", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_database_record", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } } ], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "消化系统", "sourceArchiveMarket": "美国：FDA Drugs@FDA 将 MiraLAX、NDA 022015、聚乙二醇 3350 17 g/标线量盖和 17 g/袋相连，当前列为 OTC、RLD Yes、RS Yes；DailyMed SPL v24 于 2026-05-04 生效并列出 Bayer 当前标签、NDC 与包装面板。标签或 RLD 状态不证明任何地点有库存、可购买、适合个人或与其他产品可自动互换。", "dosageFormClass": "不含辅料的聚乙二醇 3350 口服溶液用白色粉末；瓶装用原瓶标线量盖核对 17 g，独立袋每袋 17 g。克（g）、毫克（mg）、瓶内总克数、包装所写次数和个人用法必须分开理解", "dosageFormClassCode": "oral_solid", "route": "先完全溶解后口服", "routeCode": "oral", "historicalApprovalEntry": "1999（美国处方产品）；2006-10-06（美国 OTC 转换批准）", "archiveSponsorText": "Bayer HealthCare LLC（FDA 当前 NDA 与 DailyMed 标签主体）；Braintree Laboratories, Inc. 为历史开发／申请主体" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [ "MiraLAX Orange", "MiraFAST", "MiraSOFT", "MiraFIBER", "MiraGUT", "polyethylene glycol electrolyte solution", "PEG electrolyte bowel preparation", "含电解质聚乙二醇肠道清洁剂", "generic polyethylene glycol 3350", "其他厂牌聚乙二醇 3350" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-miralax-polyethylene-glycol-3350-17g-10-packet-carton-ndc-1152372683", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国 OTC 标签（SPL v24；2026-05-04 生效）", "en": "Current U.S. DailyMed OTC label (SPL v24; effective 4 May 2026)" }, "dosageForm": { "zh": "MiraLAX 聚乙二醇 3350 口服溶液用粉末独立袋", "en": "MiraLAX polyethylene glycol 3350 powder-for-oral-solution packet" }, "route": { "zh": "先完全溶解后口服（准确包装身份字段）", "en": "oral after complete dissolution (exact package-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 11523-7268-3", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_packet", "primaryDisplay": { "zh": "每袋聚乙二醇 3350 17 g；10 袋纸盒", "en": "Polyethylene glycol 3350 17 g per packet; 10-packet carton" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=C00011253_MIRALAX_RESTORALAX_MiralaxPowder_10ct_Carton_r1_clean.jpg&setid=d69ce3d4-7ca4-4fe3-b49e-6655e48d6963", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "聚乙二醇 3350", "en": "polyethylene glycol 3350" }, "value": 17, "unit": "g", "basisCode": "per_packet", "basisLabel": { "zh": "每袋标签标示量；17 g 等于 17,000 mg，但这不是个人频率、疗程或加量指令", "en": "labelled amount per packet; 17 g equals 17,000 mg, but this is not an individual's frequency, course or increase instruction" } } ], "concentration": null, "container": { "typeCode": "carton_packets", "typeLabel": { "zh": "独立袋纸盒", "en": "packet carton" }, "fill": null, "countPerPackage": 10, "countUnit": { "zh": "袋/盒", "en": "packets per carton" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-29", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 10, "unit": { "zh": "袋/盒", "en": "packets per carton" } }, "physicalClues": { "color": { "zh": "白色粉末；溶解后无色", "en": "white powder; colourless after dissolution" }, "shape": { "zh": "每袋净含量 17 g 的粉末，不是片剂或胶囊", "en": "17 g powder packet, not a tablet or capsule" }, "imprint": "MiraLAX Mix-In Pax 10", "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_f77fb16bcc208dcf", "label": "DailyMed（NLM）：MiraLAX 聚乙二醇 3350 当前美国 OTC 标签（SPL v24；2026-05-04 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d69ce3d4-7ca4-4fe3-b49e-6655e48d6963", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-miralax-polyethylene-glycol-3350-17g-20-packet-carton-ndc-1152372689", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国 OTC 标签（SPL v24；2026-05-04 生效）", "en": "Current U.S. DailyMed OTC label (SPL v24; effective 4 May 2026)" }, "dosageForm": { "zh": "MiraLAX 聚乙二醇 3350 口服溶液用粉末独立袋", "en": "MiraLAX polyethylene glycol 3350 powder-for-oral-solution packet" }, "route": { "zh": "先完全溶解后口服（准确包装身份字段）", "en": "oral after complete dissolution (exact package-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 11523-7268-9", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_packet", "primaryDisplay": { "zh": "每袋聚乙二醇 3350 17 g；20 袋纸盒", "en": "Polyethylene glycol 3350 17 g per packet; 20-packet carton" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=C00011256_MIRALAX_RESTORALAX_MiralaxPowder_20ct_Carton_r1_clean.jpg&setid=d69ce3d4-7ca4-4fe3-b49e-6655e48d6963", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "聚乙二醇 3350", "en": "polyethylene glycol 3350" }, "value": 17, "unit": "g", "basisCode": "per_packet", "basisLabel": { "zh": "每袋标签标示量；17 g 等于 17,000 mg，但这不是个人频率、疗程或加量指令", "en": "labelled amount per packet; 17 g equals 17,000 mg, but this is not an individual's frequency, course or increase instruction" } } ], "concentration": null, "container": { "typeCode": "carton_packets", "typeLabel": { "zh": "独立袋纸盒", "en": "packet carton" }, "fill": null, "countPerPackage": 20, "countUnit": { "zh": "袋/盒", "en": "packets per carton" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-29", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 20, "unit": { "zh": "袋/盒", "en": "packets per carton" } }, "physicalClues": { "color": { "zh": "白色粉末；溶解后无色", "en": "white powder; colourless after dissolution" }, "shape": { "zh": "每袋净含量 17 g 的粉末，不是片剂或胶囊", "en": "17 g powder packet, not a tablet or capsule" }, "imprint": "MiraLAX Mix-In Pax 20", "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_f77fb16bcc208dcf", "label": "DailyMed（NLM）：MiraLAX 聚乙二醇 3350 当前美国 OTC 标签（SPL v24；2026-05-04 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d69ce3d4-7ca4-4fe3-b49e-6655e48d6963", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-miralax-polyethylene-glycol-3350-510g-30-marked-cap-fills-1-bottle-pack-ndc-1152372344", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国 OTC 标签（SPL v24；2026-05-04 生效）", "en": "Current U.S. DailyMed OTC label (SPL v24; effective 4 May 2026)" }, "dosageForm": { "zh": "MiraLAX 聚乙二醇 3350 口服溶液用粉末瓶装", "en": "MiraLAX polyethylene glycol 3350 powder-for-oral-solution bottle" }, "route": { "zh": "用原瓶标线量盖量取、完全溶解后口服（准确包装身份字段）", "en": "oral after measuring with the marked original cap and complete dissolution (exact package-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 11523-7234-4", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_marked_cap_fill", "primaryDisplay": { "zh": "每次量到原瓶量盖标线为聚乙二醇 3350 17 g；510 g 瓶装；标签称约 30 个标线量", "en": "Polyethylene glycol 3350 17 g per fill to the original cap line; 510 g bottle; label describes about 30 marked-cap fills" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=C00011297_MIRALAX_510+Gram_30Dose_FrontLabel.jpg&setid=d69ce3d4-7ca4-4fe3-b49e-6655e48d6963", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "聚乙二醇 3350", "en": "polyethylene glycol 3350" }, "value": 17, "unit": "g", "basisCode": "per_marked_cap_fill", "basisLabel": { "zh": "装至原瓶量盖标线的标签标示量；瓶内总克数、包装所写次数和个人用法不是同一字段", "en": "labelled amount when filled to the original cap line; total bottle grams, pack dose count and individual use are different fields" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "带标线量盖的瓶", "en": "bottle with marked measuring cap" }, "fill": { "value": 510, "unit": "g" }, "countPerPackage": null, "countUnit": null }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-29", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 1, "unit": { "zh": "瓶；总量 510 g", "en": "bottle; 510 g total" } }, "physicalClues": { "color": { "zh": "白色粉末；溶解后无色", "en": "white powder; colourless after dissolution" }, "shape": { "zh": "瓶装粉末和带标线量盖，不是片剂、胶囊或普通勺", "en": "bottled powder with a marked cap, not a tablet, capsule or kitchen spoon" }, "imprint": "MiraLAX 30 doses", "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_f77fb16bcc208dcf", "label": "DailyMed（NLM）：MiraLAX 聚乙二醇 3350 当前美国 OTC 标签（SPL v24；2026-05-04 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d69ce3d4-7ca4-4fe3-b49e-6655e48d6963", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-miralax-polyethylene-glycol-3350-578g-34-marked-cap-fills-2-bottle-pack-ndc-1152343573", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国 OTC 标签（SPL v24；2026-05-04 生效）", "en": "Current U.S. DailyMed OTC label (SPL v24; effective 4 May 2026)" }, "dosageForm": { "zh": "MiraLAX 聚乙二醇 3350 口服溶液用粉末瓶装", "en": "MiraLAX polyethylene glycol 3350 powder-for-oral-solution bottle" }, "route": { "zh": "用原瓶标线量盖量取、完全溶解后口服（准确包装身份字段）", "en": "oral after measuring with the marked original cap and complete dissolution (exact package-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 11523-4357-3", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_marked_cap_fill", "primaryDisplay": { "zh": "每次量到原瓶量盖标线为聚乙二醇 3350 17 g；双瓶装，每瓶 578 g；标签称约 34 个标线量", "en": "Polyethylene glycol 3350 17 g per fill to the original cap line; two bottles, 578 g each; label describes about 34 marked-cap fills" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=C00011325_MIRALAX_RESTORALAX_34Dose_FrontLabel_r1_clean.jpg&setid=d69ce3d4-7ca4-4fe3-b49e-6655e48d6963", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "聚乙二醇 3350", "en": "polyethylene glycol 3350" }, "value": 17, "unit": "g", "basisCode": "per_marked_cap_fill", "basisLabel": { "zh": "装至原瓶量盖标线的标签标示量；瓶内总克数、包装所写次数和个人用法不是同一字段", "en": "labelled amount when filled to the original cap line; total bottle grams, pack dose count and individual use are different fields" } } ], "concentration": null, "container": { "typeCode": "twin_bottle_pack", "typeLabel": { "zh": "双瓶组合装", "en": "twin-bottle pack" }, "fill": { "value": 578, "unit": "g" }, "countPerPackage": null, "countUnit": null }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-29", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 2, "unit": { "zh": "瓶/组合装；每瓶 578 g", "en": "bottles per pack; 578 g each" } }, "physicalClues": { "color": { "zh": "白色粉末；溶解后无色", "en": "white powder; colourless after dissolution" }, "shape": { "zh": "瓶装粉末和带标线量盖，不是片剂、胶囊或普通勺", "en": "bottled powder with a marked cap, not a tablet, capsule or kitchen spoon" }, "imprint": "MiraLAX 34 doses", "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_f77fb16bcc208dcf", "label": "DailyMed（NLM）：MiraLAX 聚乙二醇 3350 当前美国 OTC 标签（SPL v24；2026-05-04 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d69ce3d4-7ca4-4fe3-b49e-6655e48d6963", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-miralax-polyethylene-glycol-3350-17g-20-packet-carton-ndc-1152372689", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=C00011256_MIRALAX_RESTORALAX_MiralaxPowder_20ct_Carton_r1_clean.jpg&setid=d69ce3d4-7ca4-4fe3-b49e-6655e48d6963", "alt": "MiraLAX 聚乙二醇 3350、每袋 17 g、20 袋纸盒的美国 DailyMed 官方标签展示面", "archiveMarket": "美国", "labelVersion": "DailyMed SPL v24；2026-05-04 生效", "presentation": "MiraLAX Mix-In Pax 聚乙二醇 3350，每袋 17 g，20 袋纸盒，NDC 11523-7268-9。", "notice": "此图只对应所引 DailyMed 当前标签中的 20 袋纸盒，不代表 10 袋纸盒、瓶装、双瓶装、橙味、其他 Mira 品牌家族、其他厂牌聚乙二醇 3350、其他市场包装或实时供应；不用于鉴定真伪，也不生成个人频率或疗程。", "source": { "id": "src_f77fb16bcc208dcf", "label": "DailyMed（NLM）：MiraLAX 聚乙二醇 3350 当前美国 OTC 标签（SPL v24；2026-05-04 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d69ce3d4-7ca4-4fe3-b49e-6655e48d6963", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "MiraLAX 说明书放大阅读：先分清 17 g、17,000 mg、每袋、量盖标线和瓶内总量", "en": "MiraLAX label reading: separate 17 g, 17,000 mg, per packet, the cap line and total bottle contents" }, "summary": { "zh": "当前美国 OTC 标签把每袋 17 g 和原瓶量盖装至标线 17 g 分开写明。网页放大单位、包装、完全溶解和警示信息；它不替任何人决定是否使用、使用频率、持续时间或儿童用法。", "en": "The current U.S. OTC label separately states 17 g per packet and 17 g when the original bottle cap is filled to its line. The site enlarges units, package identity, complete dissolution and warnings; it does not decide individual use, frequency, duration or paediatric use." }, "checks": [ { "zh": "1 g 等于 1,000 mg，所以 17 g 等于 17,000 mg。这只是单位换算，不表示把其他粉末、勺子或药物按 17,000 mg 自行替代，也不表示每个人的频率和疗程。", "en": "One gram equals 1,000 milligrams, so 17 g equals 17,000 mg. This is only a unit conversion; it does not make another powder, spoon or medicine self-substitutable at 17,000 mg, or determine anyone's frequency or duration." }, { "zh": "独立袋是每袋 17 g；瓶装须使用随原瓶提供、带白色标线的量盖。普通厨房勺、其他药瓶量盖、肉眼分粉或电子秤未经产品标签确认，不能当作相同的准确产品量具。", "en": "Each packet contains 17 g; the bottle uses its supplied cap with the marked white line. A kitchen spoon, another medicine's cap, visual powder splitting or an unvalidated scale is not the same labelled product measure." }, { "zh": "标签要求粉末在饮料中完全搅拌溶解，不要在仍有结块时饮用；并明确不要与用于吞咽困难的淀粉类增稠剂混合。吞咽困难者应让药师或临床团队核对安全的具体方案。", "en": "The label says to stir until fully dissolved and not drink while clumps remain; it also says not to combine with starch-based thickeners used for swallowing difficulty. A person with dysphagia needs a pharmacist or clinical team to review the specific safe plan." }, { "zh": "肾病、恶心、呕吐、腹痛、持续两周以上的排便习惯突然变化或肠易激综合征，及同时使用处方药，都属于标签要求先咨询医生或药师的情形。网页不能从年龄或症状判断个人适用性。", "en": "Kidney disease, nausea, vomiting, abdominal pain, a sudden bowel-habit change lasting over two weeks, irritable bowel syndrome, or taking a prescription medicine are label reasons to ask a doctor or pharmacist first. The site cannot decide individual suitability from age or symptoms." }, { "zh": "直肠出血，腹痛、腹胀或痉挛加重，出现腹泻，或需要使用泻药超过一周，应停止自行延长并尽快寻求专业评估。严重腹痛、持续呕吐、明显腹胀、不能排气排便、晕厥或严重脱水可能需要急救。", "en": "Rectal bleeding, worsening abdominal pain, bloating or cramping, diarrhoea, or needing a laxative beyond one week are reasons not to self-extend use and to seek professional assessment. Severe pain, persistent vomiting, marked distension, inability to pass gas or stool, fainting or severe dehydration may require emergency care." }, { "zh": "聚乙二醇电解质肠道清洁液、橙味产品、MiraFAST、MiraSOFT、其他 Mira 品牌家族和其他厂牌 PEG 3350 不是本档案四个准确包装。不要只凭‘聚乙二醇’或紫色包装就自行替换。", "en": "PEG-electrolyte bowel preparations, orange-flavour products, MiraFAST, MiraSOFT, other Mira-family products and other PEG 3350 brands are not the four exact packs in this dossier. Do not self-substitute from ‘polyethylene glycol’ or purple packaging alone." } ], "source": { "id": "src_f77fb16bcc208dcf", "label": "DailyMed（NLM）：MiraLAX 聚乙二醇 3350 当前美国 OTC 标签（SPL v24；2026-05-04 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d69ce3d4-7ca4-4fe3-b49e-6655e48d6963", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "聚乙二醇 3350 怎样起作用：渗透性保留水分，不等于所有便秘都适合自行处理", "en": "How polyethylene glycol 3350 works: osmotic water retention does not make every constipation problem suitable for self-care" }, "summary": { "zh": "FDA 历史审评资料将 PEG 3350 描述为不易吸收、具有渗透活性的物质，通过在肠道内容物中保留水分帮助增加粪便含水量。机制可以解释‘渗透性泻药’，但不能诊断便秘原因、排除梗阻或决定个人频率和持续时间。", "en": "The FDA historical review describes PEG 3350 as a poorly absorbed, osmotically active substance that retains water in intestinal contents and increases stool water. This explains an osmotic laxative, but cannot diagnose the cause of constipation, exclude obstruction or determine individual frequency and duration." }, "checks": [ { "zh": "长期卧床、脱水、饮食变化、活动减少、疾病和多种药物都可能与便秘有关。老人同时使用阿片类止痛药、抗胆碱药、铁剂、钙剂或其他药时，应把完整药单交给药师或医生核对，而不是只叠加泻药。", "en": "Bed rest, dehydration, diet change, reduced activity, illness and many medicines can contribute to constipation. An older person using opioids, anticholinergics, iron, calcium or other medicines should have the complete list reviewed rather than simply adding laxatives." }, { "zh": "‘渗透性’不表示可以与比沙可啶、番泻叶、乳果糖、镁盐或其他便秘产品自行叠加、轮换或按克数换算。成分、起效方式、警示和肾功能边界不同。", "en": "‘Osmotic’ does not permit self-combination, alternation or gram conversion with bisacodyl, senna, lactulose, magnesium salts or another constipation product. Ingredients, onset, warnings and renal boundaries differ." }, { "zh": "若怀疑粪便嵌塞、肠梗阻、严重脱水或药物不良反应，作用机制不能替代检查。持续或严重症状应使用当地医疗服务，严重时立即急救。", "en": "If impaction, obstruction, severe dehydration or an adverse drug effect is suspected, a mechanism cannot replace examination. Persistent or severe symptoms need local medical care and emergency help when serious." } ], "source": { "id": "src_6c8c24b9ba0dee95", "label": "FDA：MiraLAX NDA 022015 Rx-to-OTC 审评资料（2006；历史药理与产品背景）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/022015s000_MedR_Part3.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "regulatory_review", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_pdf", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "MiraLAX", "generic": "聚乙二醇 3350", "dosageFormClass": "不含辅料的聚乙二醇 3350 口服溶液用白色粉末；瓶装用原瓶标线量盖核对 17 g，独立袋每袋 17 g。克（g）、毫克（mg）、瓶内总克数、包装所写次数和个人用法必须分开理解" }, "labelSource": { "id": "src_f77fb16bcc208dcf", "label": "DailyMed（NLM）：MiraLAX 聚乙二醇 3350 当前美国 OTC 标签（SPL v24；2026-05-04 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d69ce3d4-7ca4-4fe3-b49e-6655e48d6963", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "productRoutes": [ { "source": { "id": "src_f77fb16bcc208dcf", "label": "DailyMed（NLM）：MiraLAX 聚乙二醇 3350 当前美国 OTC 标签（SPL v24；2026-05-04 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d69ce3d4-7ca4-4fe3-b49e-6655e48d6963", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-29", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_22a857a6b43afae2", "label": "FDA Drugs@FDA：MiraLAX NDA 022015 当前产品、RLD 与批准历史", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=022015", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_database_record", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-08-29", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-29", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "MiraLAX 是聚乙二醇 3350 口服溶液用粉末品牌档案。最容易看错的不是商品名，而是单位与量具：每袋是 17 g；瓶装标签把原瓶量盖加到标线作为 17 g。17 g 等于 17,000 mg，但瓶内总克数、包装所写‘多少次’与某个人应该如何使用不是一回事。页面帮助核对准确包装、完全溶解、肾病/腹痛/出血/腹泻和完整药单，不生成个人次数或疗程。", "history": "FDA 审评资料记录处方 MiraLAX（NDA 020698）于 1999-02-18 批准；Drugs@FDA 记录 NDA 022015 于 2006-10-06完成部分 Rx-to-OTC 转换批准。当前 Drugs@FDA 将 17 g/标线量盖与 17 g/袋列为 OTC、RLD 与 RS；DailyMed 当前 SPL v24 于 2026-05-04 生效。历史与当前文件不能被改写成实时库存或个人用药结论。", "sourceDocuments": [ { "id": "src_f77fb16bcc208dcf", "label": "DailyMed（NLM）：MiraLAX 聚乙二醇 3350 当前美国 OTC 标签（SPL v24；2026-05-04 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d69ce3d4-7ca4-4fe3-b49e-6655e48d6963", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, { "id": "src_22a857a6b43afae2", "label": "FDA Drugs@FDA：MiraLAX NDA 022015 当前产品、RLD 与批准历史", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=022015", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_database_record", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, { "id": "src_6c8c24b9ba0dee95", "label": "FDA：MiraLAX NDA 022015 Rx-to-OTC 审评资料（2006；历史药理与产品背景）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/022015s000_MedR_Part3.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "regulatory_review", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_pdf", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } ], "applicationNumber": "FDA NDA 022015（MiraLAX polyethylene glycol 3350 powder for oral solution）", "approvalTimeline": [ { "date": "1999-02-18", "title": { "zh": "处方 MiraLAX 美国批准历史", "en": "Prescription MiraLAX U.S. approval history" }, "detail": { "zh": "FDA 2006 审评资料记录处方 MiraLAX NDA 020698 于 1999-02-18 批准。该历史节点不代表当前处方状态或包装。", "en": "The FDA 2006 review records approval of prescription MiraLAX NDA 020698 on 18 Feb 1999. This historical point does not establish current prescription status or packaging." }, "source": { "id": "src_6c8c24b9ba0dee95", "label": "FDA：MiraLAX NDA 022015 Rx-to-OTC 审评资料（2006；历史药理与产品背景）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/022015s000_MedR_Part3.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "regulatory_review", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_pdf", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } }, { "date": "2006-10-06", "title": { "zh": "NDA 022015 Rx-to-OTC 转换批准", "en": "NDA 022015 Rx-to-OTC switch approved" }, "detail": { "zh": "Drugs@FDA 将该日列为 Type 8 部分 Rx-to-OTC 转换批准，并将 17 g/标线量盖与 17 g/袋列为 MiraLAX 产品。", "en": "Drugs@FDA lists a Type 8 partial Rx-to-OTC switch approval on this date and records MiraLAX 17 g per marked-cap fill and 17 g per packet products." }, "source": { "id": "src_22a857a6b43afae2", "label": "FDA Drugs@FDA：MiraLAX NDA 022015 当前产品、RLD 与批准历史", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=022015", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_database_record", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } }, { "date": "2026-05-04", "title": { "zh": "DailyMed 当前 SPL v24 生效", "en": "Current DailyMed SPL v24 effective" }, "detail": { "zh": "当前 Bayer 标签列出 Drug Facts、量盖和独立袋说明、包装 NDC、警示及官方展示面。文件日期定位标签版本，不是个人开始使用日期。", "en": "The current Bayer label lists Drug Facts, cap and packet directions, package NDCs, warnings and official panels. The date identifies the label version, not an individual's start date." }, "source": { "id": "src_f77fb16bcc208dcf", "label": "DailyMed（NLM）：MiraLAX 聚乙二醇 3350 当前美国 OTC 标签（SPL v24；2026-05-04 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d69ce3d4-7ca4-4fe3-b49e-6655e48d6963", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "当前 OTC、RLD/RS；四个准确包装展示身份已建立", "en": "Current OTC RLD/RS; four exact displayed package identities established" }, "detail": { "zh": "页面记录每袋 17 g、标线量盖 17 g、包装数量、瓶内总克数和 NDC；这些字段不证明当地库存、个人适用性或其他 PEG 产品可自动替代。", "en": "The page records 17 g per packet, 17 g per marked cap, pack count, total bottle grams and NDC. These fields do not establish local stock, individual suitability or automatic substitution with another PEG product." } }, { "market": { "zh": "中国大陆及其他市场", "en": "Mainland China and other markets" }, "status": { "zh": "待逐项建立现行市场记录", "en": "Current market record not established" }, "detail": { "zh": "不从美国 MiraLAX 名称、PEG 3350 成分或包装颜色推定当地批准、商品名、包装、供应、原研/仿制关系或可替代性。", "en": "No local approval, trade name, pack, supply, originator/generic relationship or interchangeability is inferred from the U.S. MiraLAX name, PEG 3350 ingredient or pack colour." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "17 g 是不是 17 mg？瓶上 510 g 又是什么意思？", "en": "Is 17 g the same as 17 mg, and what does 510 g on a bottle mean?" }, "answer": { "zh": "不是。17 g 等于 17,000 mg，是每袋或原瓶量盖加到标线时的标签标示量；510 g 是该瓶粉末的总净含量。单位换算和包装总量都不能替个人决定频率或疗程。", "en": "No. 17 g equals 17,000 mg and is the labelled amount per packet or per fill to the original cap line; 510 g is the bottle's total net powder content. Neither unit conversion nor total pack content determines individual frequency or duration." } }, { "question": { "zh": "家里没有原量盖，可以用普通勺子或把粉分一半吗？", "en": "Can a kitchen spoon or visual half be used if the original cap is missing?" }, "answer": { "zh": "不要自行假定等量。当前标签只核验原瓶带标线量盖和独立 17 g 袋。请带产品和包装让药师帮助确认合适的替代量具或产品；网页不从勺子外观计算克数。", "en": "Do not assume equivalence. The current label verifies only the marked original cap and individual 17 g packets. Take the product and pack to a pharmacist to confirm an appropriate measure or product; the site does not calculate grams from spoon appearance." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "dose-units-and-concentrations", "polypharmacy-safety-guide" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/miralax/", "en": "https://origindrug.com/en/drugs/miralax/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "ditropan-xl", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-29", "status": "published_traceable_archive" }, "names": { "brand": "DITROPAN XL", "generic": "盐酸奥昔布宁缓释片", "aliases": [ "Ditropan XL", "oxybutynin chloride extended release", "oxybutynin ER", "oxybutynin XL", "盐酸奥昔布宁缓释片", "奥昔布宁缓释片", "oxybutynin", "oxybutynin chloride", "oxybutynin extended release", "盐酸奥昔布宁", "NDA 020897", "5 XL", "10 XL", "15 XL" ], "marketBrandNames": [ { "name": "DITROPAN XL", "market": { "zh": "美国", "en": "United States" }, "evidenceStatus": "historical_regulatory_record", "note": { "zh": "NDA 020897 历史 RLD；5、10、15 mg 当前均列为 Discontinued。", "en": "Historical RLD under NDA 020897; 5, 10 and 15 mg are currently listed as Discontinued." }, "source": { "id": "src_f78c495e56c37bba", "label": "FDA Drugs@FDA：DITROPAN XL NDA 020897 申请、RLD 与停止销售状态", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=020897", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_database_record", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } } ], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "泌尿健康", "sourceArchiveMarket": "美国 FDA NDA 020897：DITROPAN XL 5 mg、10 mg 与 15 mg 缓释片均为历史 RLD，当前 Orange Book/Drugs@FDA 状态为 Discontinued；2021 标签覆盖 5 mg、10 mg，15 mg 外观来自 2015 有日期标签。可阅读的说明书和 NDA 档案不等于当前有货、可购买、可自行换药或适合个人。", "dosageFormClass": "盐酸奥昔布宁渗透泵缓释口服片：每片 5、10 或 15 mg；必须整片吞服，不能咀嚼、分开或压碎；不是普通即释片、糖浆或贴剂", "dosageFormClassCode": "oral_modified_release", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "1998（5 mg、10 mg）；1999（15 mg）", "archiveSponsorText": "ALZA Corporation／Janssen Pharmaceuticals, Inc.（FDA 历史品牌资料所列）" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [ "DITROPAN immediate release", "oxybutynin immediate-release tablet", "oxybutynin syrup", "oxybutynin transdermal system", "奥昔布宁普通片", "奥昔布宁口服液", "奥昔布宁贴剂", "other oxybutynin brands", "其他厂牌奥昔布宁" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-ditropan-xl-oxybutynin-chloride-5mg-tablet-nda-020897-product-001", "marketCode": "US", "labelVersion": { "zh": "FDA 2021 有日期美国标签", "en": "Dated 2021 U.S. FDA label" }, "dosageForm": { "zh": "DITROPAN XL 盐酸奥昔布宁缓释口服片", "en": "DITROPAN XL oxybutynin chloride extended-release oral tablet" }, "route": { "zh": "口服（完整渗透泵缓释片身份字段）", "en": "oral (intact osmotic extended-release tablet identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDA 020897 / Product 001", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片盐酸奥昔布宁 5 mg；美国原品牌 RLD 已停止销售", "en": "Oxybutynin chloride 5 mg per tablet; U.S. originator RLD discontinued" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "盐酸奥昔布宁", "en": "oxybutynin chloride" }, "value": 5, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、服用时刻、加减量或换药指令", "en": "labelled amount per tablet; not an individual's tablet count, timing, adjustment or switching instruction" } } ], "concentration": null, "container": { "typeCode": "historical_product_record", "typeLabel": { "zh": "历史产品记录；准确零售包装数量未由本页推定", "en": "historical product record; exact retail pack count not inferred here" }, "fill": null, "countPerPackage": null, "countUnit": null }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-29", "currentLabelDisplayed": false, "ndcDirectoryListed": false, "marketAvailability": "historical_discontinued_rld", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 1, "unit": { "zh": "个 FDA 历史产品身份（不是一片装）", "en": "FDA historical product identity (not a one-tablet pack)" } }, "physicalClues": { "color": { "zh": "淡黄色", "en": "pale yellow" }, "shape": { "zh": "圆形、双凸、无刻痕缓释片；不得咀嚼、分开或压碎", "en": "round, biconvex, unscored extended-release tablet; do not chew, divide or crush" }, "imprint": "5 XL", "scoreStatus": "unscored_do_not_split", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_d8267d0057ad16bc", "label": "FDA：DITROPAN XL 盐酸奥昔布宁缓释片美国处方信息（NDA 020897；2021 有日期标签）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020897s038lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_pdf", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-ditropan-xl-oxybutynin-chloride-10mg-tablet-nda-020897-product-002", "marketCode": "US", "labelVersion": { "zh": "FDA 2021 有日期美国标签", "en": "Dated 2021 U.S. FDA label" }, "dosageForm": { "zh": "DITROPAN XL 盐酸奥昔布宁缓释口服片", "en": "DITROPAN XL oxybutynin chloride extended-release oral tablet" }, "route": { "zh": "口服（完整渗透泵缓释片身份字段）", "en": "oral (intact osmotic extended-release tablet identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDA 020897 / Product 002", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片盐酸奥昔布宁 10 mg；美国原品牌 RLD 已停止销售", "en": "Oxybutynin chloride 10 mg per tablet; U.S. originator RLD discontinued" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "盐酸奥昔布宁", "en": "oxybutynin chloride" }, "value": 10, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、服用时刻、加减量或换药指令", "en": "labelled amount per tablet; not an individual's tablet count, timing, adjustment or switching instruction" } } ], "concentration": null, "container": { "typeCode": "historical_product_record", "typeLabel": { "zh": "历史产品记录；准确零售包装数量未由本页推定", "en": "historical product record; exact retail pack count not inferred here" }, "fill": null, "countPerPackage": null, "countUnit": null }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-29", "currentLabelDisplayed": false, "ndcDirectoryListed": false, "marketAvailability": "historical_discontinued_rld", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 1, "unit": { "zh": "个 FDA 历史产品身份（不是一片装）", "en": "FDA historical product identity (not a one-tablet pack)" } }, "physicalClues": { "color": { "zh": "粉红色", "en": "pink" }, "shape": { "zh": "圆形、双凸、无刻痕缓释片；不得咀嚼、分开或压碎", "en": "round, biconvex, unscored extended-release tablet; do not chew, divide or crush" }, "imprint": "10 XL", "scoreStatus": "unscored_do_not_split", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_d8267d0057ad16bc", "label": "FDA：DITROPAN XL 盐酸奥昔布宁缓释片美国处方信息（NDA 020897；2021 有日期标签）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020897s038lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_pdf", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-ditropan-xl-oxybutynin-chloride-15mg-tablet-nda-020897-product-003", "marketCode": "US", "labelVersion": { "zh": "FDA 2015 有日期美国标签", "en": "Dated 2015 U.S. FDA label" }, "dosageForm": { "zh": "DITROPAN XL 盐酸奥昔布宁缓释口服片", "en": "DITROPAN XL oxybutynin chloride extended-release oral tablet" }, "route": { "zh": "口服（完整渗透泵缓释片身份字段）", "en": "oral (intact osmotic extended-release tablet identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDA 020897 / Product 003", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片盐酸奥昔布宁 15 mg；美国原品牌 RLD 已停止销售", "en": "Oxybutynin chloride 15 mg per tablet; U.S. originator RLD discontinued" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "盐酸奥昔布宁", "en": "oxybutynin chloride" }, "value": 15, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、服用时刻、加减量或换药指令", "en": "labelled amount per tablet; not an individual's tablet count, timing, adjustment or switching instruction" } } ], "concentration": null, "container": { "typeCode": "historical_product_record", "typeLabel": { "zh": "历史产品记录；准确零售包装数量未由本页推定", "en": "historical product record; exact retail pack count not inferred here" }, "fill": null, "countPerPackage": null, "countUnit": null }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-29", "currentLabelDisplayed": false, "ndcDirectoryListed": false, "marketAvailability": "historical_discontinued_rld", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 1, "unit": { "zh": "个 FDA 历史产品身份（不是一片装）", "en": "FDA historical product identity (not a one-tablet pack)" } }, "physicalClues": { "color": { "zh": "灰色", "en": "grey" }, "shape": { "zh": "圆形、双凸、无刻痕缓释片；不得咀嚼、分开或压碎", "en": "round, biconvex, unscored extended-release tablet; do not chew, divide or crush" }, "imprint": "15 XL", "scoreStatus": "unscored_do_not_split", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_d9e6084cbc856cc0", "label": "FDA：DITROPAN XL 盐酸奥昔布宁缓释片历史处方信息（2015；含 15 mg 外观记录）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020897s033lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_pdf", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "status": "withheld_repackaged_or_non_exact_visual", "title": { "zh": "已核验三个强度的颜色、形状、刻印和历史 RLD 身份；未把非原品牌或再包装图片冒充为原包装", "en": "Colour, shape, imprint and historical RLD identity are verified for three strengths; no generic or repackaged image is presented as the originator pack" }, "summary": { "zh": "2021 FDA 标签列出 5 mg 淡黄色“5 XL”和 10 mg 粉红色“10 XL”；2015 标签另列 15 mg 灰色“15 XL”。本次未取得与三个历史原品牌零售包装一一对应的官方展示面，因此只提供文字身份卡和可放大说明书，不使用零售图、药片网站图或仿制品图片替代。", "en": "The 2021 FDA label lists pale-yellow 5 mg ‘5 XL’ and pink 10 mg ‘10 XL’ tablets; the 2015 label also lists grey 15 mg ‘15 XL’. No official display panels matched one-to-one to all three historical originator retail packs were obtained, so the page provides text identity cards and enlarged labels without substituting retail, pill-database or generic-product images." }, "source": { "id": "src_d8267d0057ad16bc", "label": "FDA：DITROPAN XL 盐酸奥昔布宁缓释片美国处方信息（NDA 020897；2021 有日期标签）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020897s038lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_pdf", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "DITROPAN XL 说明书放大阅读：不能掰碎，空壳可能随大便排出", "en": "DITROPAN XL label reading: do not split or crush; the shell may pass in stool" }, "summary": { "zh": "FDA 标签要求用液体整片吞服，不得咀嚼、分开或压碎。药物装在不可吸收的渗透泵外壳中，释药后外壳可能随大便排出；看到像药片的空壳不能据此补吃。", "en": "The FDA label says to swallow the tablet whole with liquids and not chew, divide or crush it. Medicine is held in a nonabsorbable osmotic shell that may pass in stool after release; seeing something tablet-like does not justify taking an extra tablet." }, "checks": [ { "zh": "5、10、15 mg 是每片标签量，不是个人一次片数。两个 5 mg 在算术上等于 10 mg，也不能据此自行拼片、加减量、替换 10 mg 产品或照搬他人的处方。", "en": "5, 10 and 15 mg are labelled amounts per tablet, not an individual's tablet count. Although two 5 mg numbers add to 10 mg, that does not permit self-assembling tablets, changing an amount, replacing a 10 mg product or copying another person's prescription." }, { "zh": "片剂必须保持完整，不要掰、切、嚼、溶解或压碎。吞咽困难时应带准确药盒和处方询问药师或开方团队，而不是自行破坏缓释结构或换成糖浆、普通片、贴剂。", "en": "Keep the tablet intact; do not split, cut, chew, dissolve or crush it. For swallowing difficulty, take the exact pack and prescription to a pharmacist or prescriber instead of disrupting extended release or self-switching to syrup, immediate-release tablets or a patch." }, { "zh": "口干、便秘、尿不出、嗜睡、头晕、视物模糊、意识混乱或幻觉可能与抗胆碱作用有关。老人、认知功能下降者及同时使用安眠药、抗过敏药、止吐药、膀胱药或其他抗胆碱药者，应优先核对完整药单。", "en": "Dry mouth, constipation, inability to urinate, drowsiness, dizziness, blurred vision, confusion or hallucinations may relate to anticholinergic effects. Older adults, people with cognitive impairment and those using sleeping, allergy, nausea, bladder or other anticholinergic medicines need priority review of the complete medicine list." }, { "zh": "面唇舌喉肿胀或呼吸困难需要立即急救；高温环境下少汗、体温升高、意识变化也可能是严重情况。严重便秘、腹胀、不能排便排气或尿潴留需要尽快医疗评估。", "en": "Swelling of the face, lips, tongue or throat or difficulty breathing needs emergency help. Reduced sweating, high temperature or mental-status change in heat can also be serious. Severe constipation, distension, inability to pass stool or gas, or urinary retention needs prompt medical assessment." }, { "zh": "尿潴留、胃潴留或严重胃肠动力下降、未控制的闭角型青光眼属于标签禁忌；重症肌无力、自主神经病变、反流性食管炎、肝肾功能问题及痴呆治疗用药也应主动告知专业人员。", "en": "Urinary retention, gastric retention or severe reduced gastrointestinal motility and uncontrolled narrow-angle glaucoma are labelled contraindications. Myasthenia gravis, autonomic neuropathy, reflux disease, liver or kidney problems and dementia medicines also need to be disclosed to the professional." } ], "source": { "id": "src_d8267d0057ad16bc", "label": "FDA：DITROPAN XL 盐酸奥昔布宁缓释片美国处方信息（NDA 020897；2021 有日期标签）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020897s038lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_pdf", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "DITROPAN XL 怎样起作用：阻断毒蕈碱受体与渗透泵缓释是两层不同概念", "en": "How DITROPAN XL works: muscarinic blockade and osmotic extended release are two different layers" }, "summary": { "zh": "奥昔布宁及其活性代谢物通过抗毒蕈碱作用降低膀胱平滑肌相关活动；OROS 外壳则利用渗透压控制药物释放。作用机制解释产品设计，不证明某个老人一定适合，也不能从症状、年龄或毫克数生成个人方案。", "en": "Oxybutynin and its active metabolite act through antimuscarinic effects related to bladder smooth muscle, while the OROS shell uses osmotic pressure to control release. Mechanism explains product design; it does not prove suitability for an older person or generate an individual plan from symptoms, age or milligrams." }, "checks": [ { "zh": "减少膀胱急迫感的机制同时可能影响口腔、肠道、眼睛、排尿、出汗和中枢神经系统，所以不能只看“膀胱药”而忽略全身不适和完整药单。", "en": "The same mechanism used for bladder urgency can also affect the mouth, bowel, eyes, urination, sweating and central nervous system, so a ‘bladder medicine’ label must not hide whole-body symptoms or the complete medicine list." }, { "zh": "缓释片、普通奥昔布宁片、糖浆和贴剂的释放与吸收路径不同；不要按相同毫克数自行叠加、轮换或互换，也不要与 VESIcare、MYRBETRIQ 等其他膀胱药自行同服。", "en": "Extended-release tablets, immediate-release oxybutynin, syrup and patches have different release and absorption paths. Do not self-combine, alternate or exchange them by matching milligrams, or add another bladder medicine such as VESIcare or MYRBETRIQ without review." }, { "zh": "全基因筛查不是网页为这类选择设定的通用前提。实际核对更需要准确诊断、症状目标、认知与跌倒风险、排尿与肠道情况、青光眼史、肝肾功能及全部用药。", "en": "Whole-genome screening is not a universal prerequisite set by this site for this choice. Review more directly requires the exact diagnosis and goals, cognition and fall risk, urinary and bowel status, glaucoma history, liver and kidney function, and all medicines." } ], "source": { "id": "src_d8267d0057ad16bc", "label": "FDA：DITROPAN XL 盐酸奥昔布宁缓释片美国处方信息（NDA 020897；2021 有日期标签）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020897s038lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_pdf", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "DITROPAN XL", "generic": "盐酸奥昔布宁缓释片", "dosageFormClass": "盐酸奥昔布宁渗透泵缓释口服片：每片 5、10 或 15 mg；必须整片吞服，不能咀嚼、分开或压碎；不是普通即释片、糖浆或贴剂" }, "labelSource": { "id": "src_d8267d0057ad16bc", "label": "FDA：DITROPAN XL 盐酸奥昔布宁缓释片美国处方信息（NDA 020897；2021 有日期标签）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020897s038lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_pdf", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "productRoutes": [ { "source": { "id": "src_d8267d0057ad16bc", "label": "FDA：DITROPAN XL 盐酸奥昔布宁缓释片美国处方信息（NDA 020897；2021 有日期标签）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020897s038lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_pdf", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-08-29", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_d9e6084cbc856cc0", "label": "FDA：DITROPAN XL 盐酸奥昔布宁缓释片历史处方信息（2015；含 15 mg 外观记录）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020897s033lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_pdf", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-08-29", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_f78c495e56c37bba", "label": "FDA Drugs@FDA：DITROPAN XL NDA 020897 申请、RLD 与停止销售状态", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=020897", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_database_record", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-08-29", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-08-29", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "DITROPAN XL 是盐酸奥昔布宁渗透泵缓释片的美国历史原品牌档案。最需要看懂的三点是：5、10、15 mg 都是每片强度，不是一次吃几片；片剂必须整片吞服，不能掰、切、嚼或压碎；空壳可能随大便排出，不应因此补吃。老人出现口干、便秘、尿潴留、嗜睡、视物模糊、过热或意识变化时，还要核对完整药单和抗胆碱负担。本页不提供个人剂量、停药或换药方案。", "history": "FDA 原始资料记录 NDA 020897 于 1998-12-16 批准 5 mg 与 10 mg，并于 1999-06-22 批准 15 mg。产品采用 OROS 渗透泵系统，水分进入片芯后推动药物通过激光微孔缓慢释放。当前美国原品牌三个规格均列为停止销售；页面保留有日期标签和监管历史，不将其写成当前供应。", "sourceDocuments": [ { "id": "src_d8267d0057ad16bc", "label": "FDA：DITROPAN XL 盐酸奥昔布宁缓释片美国处方信息（NDA 020897；2021 有日期标签）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020897s038lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_pdf", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, { "id": "src_d9e6084cbc856cc0", "label": "FDA：DITROPAN XL 盐酸奥昔布宁缓释片历史处方信息（2015；含 15 mg 外观记录）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020897s033lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_pdf", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, { "id": "src_f78c495e56c37bba", "label": "FDA Drugs@FDA：DITROPAN XL NDA 020897 申请、RLD 与停止销售状态", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=020897", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_database_record", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, { "id": "src_90bd13ae76e8ae0a", "label": "FDA：DITROPAN XL NDA 020897 原始批准与医学审评资料（1998）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20897_appltr_medr.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_regulatory_record", "documentKind": "regulatory_review", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_pdf", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } ], "applicationNumber": "FDA NDA 020897（DITROPAN XL / oxybutynin chloride extended-release tablets；三个历史 RLD 均已停止销售）", "approvalTimeline": [ { "date": "1998-12-16", "title": { "zh": "FDA 批准 5 mg 与 10 mg DITROPAN XL", "en": "FDA approved DITROPAN XL 5 mg and 10 mg" }, "detail": { "zh": "FDA 原始批准资料把两个渗透泵缓释规格与 NDA 020897、ALZA 和膀胱过度活动症状适应症相连。", "en": "The FDA original approval material links the two osmotic extended-release strengths to NDA 020897, ALZA and overactive-bladder symptoms." }, "source": { "id": "src_90bd13ae76e8ae0a", "label": "FDA：DITROPAN XL NDA 020897 原始批准与医学审评资料（1998）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20897_appltr_medr.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_regulatory_record", "documentKind": "regulatory_review", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_pdf", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } }, { "date": "1999-06-22", "title": { "zh": "FDA 批准 15 mg 产品", "en": "FDA approved the 15 mg product" }, "detail": { "zh": "当前 Orange Book 档案保留 Product 003、15 mg、RLD 与该批准日期；现状态为 Discontinued。", "en": "The current Orange Book archive retains Product 003, 15 mg, RLD identity and this approval date; status is now Discontinued." }, "source": { "id": "src_f78c495e56c37bba", "label": "FDA Drugs@FDA：DITROPAN XL NDA 020897 申请、RLD 与停止销售状态", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=020897", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_database_record", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } }, { "date": "2021", "title": { "zh": "FDA 最近核验的有日期标签节点", "en": "Most recent dated FDA label node reviewed" }, "detail": { "zh": "2021 S-038 标签列 5 mg 与 10 mg，并强化整片吞服、抗胆碱中枢作用、血管性水肿和热衰竭等阅读边界；它不证明产品仍在销售。", "en": "The 2021 S-038 label lists 5 mg and 10 mg and supports whole-tablet, anticholinergic CNS, angioedema and heat-prostration reading boundaries; it does not prove continued marketing." }, "source": { "id": "src_d8267d0057ad16bc", "label": "FDA：DITROPAN XL 盐酸奥昔布宁缓释片美国处方信息（NDA 020897；2021 有日期标签）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020897s038lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_pdf", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } }, { "date": "2026-08-29", "title": { "zh": "复核美国当前产品状态", "en": "Current U.S. product status reviewed" }, "detail": { "zh": "NDA 020897 的 5、10、15 mg 三个 RLD 产品均列为 Discontinued。该日是本站复核日，不是停止销售决定日期。", "en": "All three 5, 10 and 15 mg RLD products under NDA 020897 are listed as Discontinued. This is the site's review date, not the discontinuation decision date." }, "source": { "id": "src_f78c495e56c37bba", "label": "FDA Drugs@FDA：DITROPAN XL NDA 020897 申请、RLD 与停止销售状态", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=020897", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_database_record", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "历史 RLD 档案；5、10、15 mg 均已停止销售", "en": "Historical RLD archive; 5, 10 and 15 mg are discontinued" }, "detail": { "zh": "页面提供三种文字身份卡、有日期说明书和历史审评入口，不提供库存、购买、真伪、可替代性或个人适用性结论。", "en": "The page provides three text identity cards, dated labels and historical review routes; it does not establish stock, purchase, authenticity, interchangeability or individual suitability." } }, { "market": { "zh": "中国大陆、欧盟、日本及其他市场", "en": "Mainland China, EU, Japan and other markets" }, "status": { "zh": "待逐项建立现行市场记录", "en": "Current market records not established" }, "detail": { "zh": "不从美国历史品牌、NDA、RLD、通用名、毫克数或外观推定当地商品名、批准、包装、供应或可替代性。", "en": "No local brand, approval, pack, supply or interchangeability is inferred from the historical U.S. brand, NDA, RLD identity, generic name, milligrams or appearance." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "大便里看到像药片的东西，是不是药没吸收？", "en": "Does something tablet-like in stool mean the medicine was not absorbed?" }, "answer": { "zh": "不一定。FDA 标签说明不可吸收的释药外壳可能随大便排出。不要因此补吃一片；若症状控制异常、持续担忧或伴有严重胃肠症状，请联系专业人员。", "en": "Not necessarily. The FDA label says the nonabsorbable release shell may pass in stool. Do not take an extra tablet because of this; contact a professional for unusual symptom control, persistent concern or serious gastrointestinal symptoms." } }, { "question": { "zh": "10 mg 可以掰一半当 5 mg 吗？", "en": "Can a 10 mg tablet be split to make 5 mg?" }, "answer": { "zh": "不能自行这样做。DITROPAN XL 是无刻痕渗透泵缓释片，FDA 标签要求整片吞服、不得咀嚼、分开或压碎。需要调整时应核对准确处方和可用产品。", "en": "Do not do this yourself. DITROPAN XL is an unscored osmotic extended-release tablet, and the FDA label requires swallowing whole without chewing, dividing or crushing. Any adjustment requires review of the exact prescription and available product." } }, { "question": { "zh": "和 VESIcare、MYRBETRIQ 或奥昔布宁普通片能一起吃吗？", "en": "Can it be taken with VESIcare, MYRBETRIQ or immediate-release oxybutynin?" }, "answer": { "zh": "网页不能仅凭药名决定。它们成分、作用和不良反应边界不同；重复抗胆碱作用、尿潴留、便秘、嗜睡、认知和跌倒风险都需要结合完整药单、诊断和个体情况由专业人员核对。", "en": "The site cannot decide from names alone. Ingredients, actions and adverse-effect boundaries differ; duplicate anticholinergic effects, urinary retention, constipation, drowsiness, cognition and fall risk require professional review of the complete medicine list, diagnosis and individual context." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "dosage-forms-are-part-of-medicine-identity", "medicine-label-for-everyday-questions", "how-to-read-a-drug-label" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/ditropan-xl/", "en": "https://origindrug.com/en/drugs/ditropan-xl/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "detrol-la", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-29", "status": "published_traceable_archive" }, "names": { "brand": "DETROL LA", "generic": "酒石酸托特罗定缓释胶囊", "aliases": [ "Detrol LA", "tolterodine tartrate extended release", "tolterodine ER", "tolterodine LA", "酒石酸托特罗定缓释胶囊", "托特罗定缓释胶囊", "tolterodine", "tolterodine tartrate", "tolterodine extended release", "酒石酸托特罗定", "NDA 021228", "58151-103-93", "58151-104-93" ], "marketBrandNames": [ { "name": "DETROL LA", "market": { "zh": "美国", "en": "United States" }, "evidenceStatus": "current_regulatory_record_with_dated_package_panels", "note": { "zh": "NDA 021228；2 mg 与 4 mg 为当前 Orange Book 处方 RLD，4 mg 同时为 RS；所示 30 粒瓶装 NDC 的营销终止日均为 2026-07-31。", "en": "NDA 021228; 2 mg and 4 mg are current Orange Book prescription RLD products, with 4 mg also the RS; both displayed 30-capsule NDCs have a marketing end date of 31 Jul 2026." }, "source": { "id": "src_d0d3bf3f5a6655e3", "label": "FDA Drugs@FDA：DETROL LA NDA 021228 当前申请、RLD 与 RS 记录", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=021228", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_database_record", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } } ], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "泌尿健康", "sourceArchiveMarket": "美国：FDA Orange Book 当前数据将 DETROL LA 2 mg 与 4 mg 缓释胶囊列为处方 RLD，并将 4 mg 列为 RS。DailyMed SPL v4 提供两个 30 粒瓶装准确面板，但所示 NDC 58151-103-93 与 58151-104-93 的营销终止日均为 2026-07-31；因此页面只把图片作为有日期包装档案，不解释为当前库存、可购买或仍在营销。", "dosageFormClass": "酒石酸托特罗定缓释口服胶囊：每粒 2 mg 或 4 mg；标签要求用液体整粒吞服；不是托特罗定普通片、非索罗定缓释片或其他膀胱药", "dosageFormClassCode": "oral_modified_release", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "2000-12-22（美国 FDA 初始批准）", "archiveSponsorText": "Upjohn US 2 LLC（FDA Orange Book 当前申请主体）；Viatris Specialty LLC（所引 DailyMed 标签主体）" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [ "DETROL immediate release", "tolterodine immediate-release tablet", "托特罗定普通片", "fesoterodine", "TOVIAZ", "other tolterodine brands", "其他厂牌托特罗定" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-detrol-la-tolterodine-tartrate-2mg-30-capsule-bottle-ndc-5815110393", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v4（2025-06-09 发布；处方信息 2023-03 修订；该 NDC 营销终止日 2026-07-31）", "en": "DailyMed SPL v4 (published 9 Jun 2025; prescribing information revised Mar 2023; this NDC marketing end date 31 Jul 2026)" }, "dosageForm": { "zh": "DETROL LA 酒石酸托特罗定缓释口服胶囊", "en": "DETROL LA tolterodine tartrate extended-release oral capsule" }, "route": { "zh": "口服（完整缓释胶囊身份字段）", "en": "oral (intact extended-release capsule identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 58151-103-93", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_capsule", "primaryDisplay": { "zh": "每粒酒石酸托特罗定 2 mg；30 粒瓶装；该包装记录营销终止日为 2026-07-31", "en": "Tolterodine tartrate 2 mg per capsule; 30-capsule bottle; this package record has a marketing end date of 31 Jul 2026" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=image-01.jpg&archiveid=894296", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "酒石酸托特罗定", "en": "tolterodine tartrate" }, "value": 2, "unit": "mg", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒标签标示量；不是个人一次粒数、使用频率、加减量或换药指令", "en": "labelled amount per capsule; not an individual's capsule count, frequency, adjustment or switching instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "30 粒处方药瓶装标签展示面", "en": "30-capsule prescription bottle label panel" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-29", "currentLabelDisplayed": false, "ndcDirectoryListed": true, "marketAvailability": "dated_package_record_marketing_ended_2026_07_31", "marketingStartDate": null, "marketingEndDate": "2026-07-31", "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 30, "unit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "physicalClues": { "color": { "zh": "蓝绿色，白色数字 2", "en": "blue-green with a white numeral 2" }, "shape": { "zh": "胶囊，约 14 mm；无刻痕；标签要求整粒吞服", "en": "capsule, approximately 14 mm; unscored; label says to swallow whole" }, "imprint": "2", "scoreStatus": "unscored_swallow_whole", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_8714749625c99e4a", "label": "DailyMed（NLM）：DETROL LA 酒石酸托特罗定缓释胶囊美国品牌标签（SPL v4；2025-06-09 发布；处方信息 2023-03 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=d7274947-4f88-47ee-a39f-bd5ac46fcf8d&version=4", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-detrol-la-tolterodine-tartrate-4mg-30-capsule-bottle-ndc-5815110493", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v4（2025-06-09 发布；处方信息 2023-03 修订；该 NDC 营销终止日 2026-07-31）", "en": "DailyMed SPL v4 (published 9 Jun 2025; prescribing information revised Mar 2023; this NDC marketing end date 31 Jul 2026)" }, "dosageForm": { "zh": "DETROL LA 酒石酸托特罗定缓释口服胶囊", "en": "DETROL LA tolterodine tartrate extended-release oral capsule" }, "route": { "zh": "口服（完整缓释胶囊身份字段）", "en": "oral (intact extended-release capsule identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 58151-104-93", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_capsule", "primaryDisplay": { "zh": "每粒酒石酸托特罗定 4 mg；30 粒瓶装；该包装记录营销终止日为 2026-07-31", "en": "Tolterodine tartrate 4 mg per capsule; 30-capsule bottle; this package record has a marketing end date of 31 Jul 2026" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=image-02.jpg&archiveid=894296", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "酒石酸托特罗定", "en": "tolterodine tartrate" }, "value": 4, "unit": "mg", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒标签标示量；不是个人一次粒数、使用频率、加减量或换药指令", "en": "labelled amount per capsule; not an individual's capsule count, frequency, adjustment or switching instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "30 粒处方药瓶装标签展示面", "en": "30-capsule prescription bottle label panel" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-29", "currentLabelDisplayed": false, "ndcDirectoryListed": true, "marketAvailability": "dated_package_record_marketing_ended_2026_07_31", "marketingStartDate": null, "marketingEndDate": "2026-07-31", "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 30, "unit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "physicalClues": { "color": { "zh": "蓝色，白色数字 4", "en": "blue with a white numeral 4" }, "shape": { "zh": "胶囊，约 16 mm；无刻痕；标签要求整粒吞服", "en": "capsule, approximately 16 mm; unscored; label says to swallow whole" }, "imprint": "4", "scoreStatus": "unscored_swallow_whole", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_8714749625c99e4a", "label": "DailyMed（NLM）：DETROL LA 酒石酸托特罗定缓释胶囊美国品牌标签（SPL v4；2025-06-09 发布；处方信息 2023-03 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=d7274947-4f88-47ee-a39f-bd5ac46fcf8d&version=4", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-detrol-la-tolterodine-tartrate-4mg-30-capsule-bottle-ndc-5815110493", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=image-02.jpg&archiveid=894296", "alt": "DETROL LA 酒石酸托特罗定缓释胶囊 4 mg、30 粒、NDC 58151-104-93 的美国 DailyMed 有日期包装标签展示面", "archiveMarket": "美国", "labelVersion": "DailyMed SPL v4；2025-06-09 发布；该 NDC 营销终止日 2026-07-31", "presentation": "DETROL LA 酒石酸托特罗定缓释胶囊 4 mg，30 粒瓶装，NDC 58151-104-93。", "notice": "此图只对应所引 DailyMed 有日期标签中的 4 mg、30 粒瓶装；该 NDC 的营销终止日为 2026-07-31。它不用于鉴定真伪，也不证明当前库存、可购买、其他包装、2 mg、普通片、其他厂牌、其他市场或个人适用性。", "source": { "id": "src_8714749625c99e4a", "label": "DailyMed（NLM）：DETROL LA 酒石酸托特罗定缓释胶囊美国品牌标签（SPL v4；2025-06-09 发布；处方信息 2023-03 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=d7274947-4f88-47ee-a39f-bd5ac46fcf8d&version=4", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "DETROL LA 说明书放大阅读：整粒吞服，先核对抗胆碱负担和完整药单", "en": "DETROL LA label reading: swallow the capsule whole and review anticholinergic burden with the complete medicine list" }, "summary": { "zh": "标签要求用液体整粒吞服；如果不能吞下胶囊，应告知医生。网页不把 2 mg、4 mg 变成个人选择题，也不把‘缓释胶囊’解释成可以自行打开、分粒、压碎或换成普通片。", "en": "The label says to swallow the capsule whole with liquid and tell the doctor if the capsule cannot be swallowed. The site does not turn 2 mg and 4 mg into an individual choice or interpret ‘extended-release capsule’ as permission to open, divide, crush or replace it with an immediate-release tablet." }, "checks": [ { "zh": "2 mg 与 4 mg 是每粒标签量，30 粒是瓶内数量。两个 2 mg 在算术上等于 4 mg，也不能据此自行拼粒、加减量、替换 4 mg 产品、补服或照搬他人的处方。", "en": "2 mg and 4 mg are labelled amounts per capsule, while 30 is the bottle count. Although two 2 mg numbers add to 4 mg, that does not permit self-assembling capsules, changing an amount, replacing a 4 mg product, making up a dose or copying another person's prescription." }, { "zh": "用液体整粒吞服。标签没有把胶囊外观、无刻痕或‘缓释’写成可自行打开、嚼碎、压碎、分装或拌食的许可；吞咽困难时应带准确药盒和处方让药师或开方团队核对可行方案。", "en": "Swallow the capsule whole with liquid. The label does not turn capsule appearance, lack of a score or ‘extended release’ into permission to open, chew, crush, divide or sprinkle it. For swallowing difficulty, take the exact pack and prescription to a pharmacist or prescriber for an appropriate plan." }, { "zh": "口干、便秘、腹痛、视物模糊、头晕或嗜睡是标签提示的重要不良反应线索。老人、认知功能下降者或有跌倒风险者，以及同时使用安眠药、抗过敏药、止吐药、膀胱药或其他抗胆碱药者，应优先核对完整药单。", "en": "Dry mouth, constipation, abdominal pain, blurred vision, dizziness or drowsiness are important label adverse-effect cues. Older adults, people with cognitive impairment or fall risk, and those using sleeping, allergy, nausea, bladder or other anticholinergic medicines need priority review of the complete medicine list." }, { "zh": "尿潴留、胃潴留和未控制的闭角型青光眼属于标签禁忌；胃肠梗阻或动力下降、重症肌无力、肝肾功能问题和 QT 间期延长史也需要主动说明。", "en": "Urinary retention, gastric retention and uncontrolled narrow-angle glaucoma are labelled contraindications. Gastrointestinal obstruction or reduced motility, myasthenia gravis, liver or kidney impairment and a history of QT prolongation also need to be disclosed." }, { "zh": "面部、嘴唇、舌或咽喉肿胀、呼吸困难、上气道阻塞或血压下降需要立即急救。严重腹胀、不能排便排气、不能排尿、晕厥或明显意识变化也应尽快获得医疗评估。", "en": "Swelling of the face, lips, tongue or throat, breathing difficulty, upper-airway obstruction or a fall in blood pressure needs emergency help. Severe distension, inability to pass stool or gas, inability to urinate, fainting or marked mental-status change also needs prompt medical assessment." }, { "zh": "强 CYP3A4 抑制剂、其他抗胆碱药及某些影响 QT 的药可能改变风险。标签示例包括克拉霉素、利托那韦、酮康唑和部分抗心律失常药；网页不据此生成个人减量或错开时间表。", "en": "Potent CYP3A4 inhibitors, other anticholinergics and some QT-related medicines may change risk. Label examples include clarithromycin, ritonavir, ketoconazole and certain antiarrhythmics; the site does not generate an individual reduction or time-separation schedule from this information." } ], "source": { "id": "src_8714749625c99e4a", "label": "DailyMed（NLM）：DETROL LA 酒石酸托特罗定缓释胶囊美国品牌标签（SPL v4；2025-06-09 发布；处方信息 2023-03 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=d7274947-4f88-47ee-a39f-bd5ac46fcf8d&version=4", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "DETROL LA 怎样起作用：抗毒蕈碱作用与缓释胶囊是两层不同概念", "en": "How DETROL LA works: antimuscarinic action and an extended-release capsule are two different concepts" }, "summary": { "zh": "托特罗定及其活性代谢物作用于毒蕈碱受体相关通路，帮助降低膀胱不自主收缩；缓释胶囊则描述药物释放方式。机制解释产品设计，不证明某个老人一定适合，也不能从尿频、年龄或毫克数生成个人方案。", "en": "Tolterodine and its active metabolite act through muscarinic-receptor pathways related to bladder contraction, while the extended-release capsule describes how medicine is released. Mechanism explains product design; it does not prove suitability for an older person or generate an individual plan from urinary frequency, age or milligrams." }, "checks": [ { "zh": "同一作用路径也可能影响唾液、肠道、眼睛、排尿和中枢神经系统，因此不能只把它看成‘膀胱药’，忽略便秘、视物模糊、嗜睡、意识变化和完整药单。", "en": "The same pathway can also affect saliva, bowel, eyes, urination and the central nervous system, so a ‘bladder medicine’ label must not hide constipation, blurred vision, drowsiness, mental-status change or the complete medicine list." }, { "zh": "DETROL LA、DITROPAN XL、VESIcare、TOVIAZ 与 MYRBETRIQ 是不同产品；相同用途不表示成分、受体作用、缓释结构、相互作用或不良反应相同，不能按毫克数自行叠加、轮换或替换。", "en": "DETROL LA, DITROPAN XL, VESIcare, TOVIAZ and MYRBETRIQ are different products. A shared use does not make their ingredients, receptor actions, release designs, interactions or adverse effects the same, and does not permit self-combination, alternation or substitution by milligrams." }, { "zh": "全基因筛查不是本站为这种选择设定的通用前提。实际核对更需要准确诊断和目标、认知与跌倒风险、排尿和肠道情况、青光眼与心律史、肝肾功能及全部用药。", "en": "Whole-genome screening is not a universal prerequisite set by this site for this choice. Review more directly requires the exact diagnosis and goals, cognition and fall risk, urinary and bowel status, glaucoma and rhythm history, liver and kidney function, and all medicines." } ], "source": { "id": "src_d8de723fa4211d33", "label": "FDA：DETROL LA 酒石酸托特罗定缓释胶囊有日期处方信息（2018）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021228s023lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_pdf", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "DETROL LA", "generic": "酒石酸托特罗定缓释胶囊", "dosageFormClass": "酒石酸托特罗定缓释口服胶囊：每粒 2 mg 或 4 mg；标签要求用液体整粒吞服；不是托特罗定普通片、非索罗定缓释片或其他膀胱药" }, "labelSource": { "id": "src_8714749625c99e4a", "label": "DailyMed（NLM）：DETROL LA 酒石酸托特罗定缓释胶囊美国品牌标签（SPL v4；2025-06-09 发布；处方信息 2023-03 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=d7274947-4f88-47ee-a39f-bd5ac46fcf8d&version=4", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "productRoutes": [ { "source": { "id": "src_8714749625c99e4a", "label": "DailyMed（NLM）：DETROL LA 酒石酸托特罗定缓释胶囊美国品牌标签（SPL v4；2025-06-09 发布；处方信息 2023-03 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=d7274947-4f88-47ee-a39f-bd5ac46fcf8d&version=4", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-29", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_d0d3bf3f5a6655e3", "label": "FDA Drugs@FDA：DETROL LA NDA 021228 当前申请、RLD 与 RS 记录", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=021228", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_database_record", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-08-29", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_d8de723fa4211d33", "label": "FDA：DETROL LA 酒石酸托特罗定缓释胶囊有日期处方信息（2018）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021228s023lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_pdf", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-08-29", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-29", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "DETROL LA 是酒石酸托特罗定缓释胶囊的美国品牌档案。普通人最需要先看懂三件事：2 mg、4 mg 是每粒强度，不是一次吃几粒；标签要求整粒吞服，吞咽困难不能自行打开、咬碎或改换普通片；它具有抗毒蕈碱作用，老人出现口干、便秘、尿不出、视物模糊、头晕、嗜睡或意识变化时，应把完整药单交给药师或开方团队核对。本页不提供个人剂量、停药、换药或联用方案。", "history": "FDA 原始资料将 DETROL LA 2 mg 与 4 mg 缓释胶囊的初始美国批准日期列为 2000-12-22。当前 Orange Book 保留两个处方 RLD 产品，并将 4 mg 列为 RS。DailyMed SPL v4 于 2025-06-09 发布、处方信息修订于 2023-03；所示两个 30 粒瓶装 NDC 的营销终止日为 2026-07-31。页面保留其来源和版本，不把历史或有日期包装写成实时供应。", "sourceDocuments": [ { "id": "src_8714749625c99e4a", "label": "DailyMed（NLM）：DETROL LA 酒石酸托特罗定缓释胶囊美国品牌标签（SPL v4；2025-06-09 发布；处方信息 2023-03 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=d7274947-4f88-47ee-a39f-bd5ac46fcf8d&version=4", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, { "id": "src_d0d3bf3f5a6655e3", "label": "FDA Drugs@FDA：DETROL LA NDA 021228 当前申请、RLD 与 RS 记录", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=021228", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_database_record", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, { "id": "src_d8de723fa4211d33", "label": "FDA：DETROL LA 酒石酸托特罗定缓释胶囊有日期处方信息（2018）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021228s023lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_pdf", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, { "id": "src_807fb7308d2969bc", "label": "FDA：DETROL LA NDA 021228 原始批准标签（2000）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21228lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_regulatory_record", "documentKind": "regulatory_review", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_pdf", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } ], "applicationNumber": "FDA NDA 021228（DETROL LA / tolterodine tartrate extended-release capsules）", "approvalTimeline": [ { "date": "2000-12-22", "title": { "zh": "FDA 初始批准 DETROL LA 2 mg 与 4 mg", "en": "FDA initially approved DETROL LA 2 mg and 4 mg" }, "detail": { "zh": "FDA 原始标签与当前 Orange Book 将两个缓释胶囊规格与 NDA 021228 相连。", "en": "The FDA original label and current Orange Book link both extended-release capsule strengths to NDA 021228." }, "source": { "id": "src_807fb7308d2969bc", "label": "FDA：DETROL LA NDA 021228 原始批准标签（2000）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21228lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_regulatory_record", "documentKind": "regulatory_review", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_pdf", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } }, { "date": "2023-03", "title": { "zh": "所引 DailyMed 处方信息修订节点", "en": "Cited DailyMed prescribing-information revision" }, "detail": { "zh": "标签提供整粒吞服、抗胆碱中枢作用、尿潴留、胃肠道、青光眼、QT 与相互作用等阅读边界。", "en": "The label supports whole-capsule, anticholinergic CNS, urinary-retention, gastrointestinal, glaucoma, QT and interaction reading boundaries." }, "source": { "id": "src_8714749625c99e4a", "label": "DailyMed（NLM）：DETROL LA 酒石酸托特罗定缓释胶囊美国品牌标签（SPL v4；2025-06-09 发布；处方信息 2023-03 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=d7274947-4f88-47ee-a39f-bd5ac46fcf8d&version=4", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } }, { "date": "2025-06-09", "title": { "zh": "DailyMed SPL v4 发布", "en": "DailyMed SPL v4 published" }, "detail": { "zh": "该版本提供 2 mg 与 4 mg、30 粒瓶装准确面板及 NDC；页面同时保留其包装营销终止日期。", "en": "This version provides exact 2 mg and 4 mg 30-capsule bottle panels and NDCs, while retaining their package marketing end dates." }, "source": { "id": "src_8714749625c99e4a", "label": "DailyMed（NLM）：DETROL LA 酒石酸托特罗定缓释胶囊美国品牌标签（SPL v4；2025-06-09 发布；处方信息 2023-03 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=d7274947-4f88-47ee-a39f-bd5ac46fcf8d&version=4", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } }, { "date": "2026-08-29", "title": { "zh": "复核美国当前 Orange Book 身份", "en": "Current U.S. Orange Book identity reviewed" }, "detail": { "zh": "2 mg 与 4 mg 均列为处方 RLD，4 mg 同时为 RS。该复核不证明任何药房当前有货。", "en": "Both 2 mg and 4 mg are listed as prescription RLD products, with 4 mg also the RS. This review does not establish current pharmacy stock." }, "source": { "id": "src_d0d3bf3f5a6655e3", "label": "FDA Drugs@FDA：DETROL LA NDA 021228 当前申请、RLD 与 RS 记录", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=021228", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_database_record", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "当前 Orange Book RLD 身份；所示两个包装 NDC 已过营销终止日", "en": "Current Orange Book RLD identity; both displayed package NDCs are past their marketing end date" }, "detail": { "zh": "准确图像仍用于核对有日期的品牌、通用名、每粒强度、NDC 和包装数量；不证明当前供应、购买资格、真伪或个人适用性。", "en": "Exact images remain useful for checking the dated brand, generic name, per-capsule strength, NDC and pack count; they do not establish current supply, purchase eligibility, authenticity or individual suitability." } }, { "market": { "zh": "中国大陆、欧盟、日本及其他市场", "en": "Mainland China, EU, Japan and other markets" }, "status": { "zh": "待逐项建立现行市场记录", "en": "Current market records not established" }, "detail": { "zh": "不从美国品牌、NDA、RLD、通用名、毫克数或包装颜色推定当地商品名、批准、包装、供应或可替代性。", "en": "No local brand, approval, pack, supply or interchangeability is inferred from the U.S. brand, NDA, RLD identity, generic name, milligrams or package colour." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "4 mg 胶囊可以打开倒一半，变成 2 mg 吗？", "en": "Can a 4 mg capsule be opened and half used as 2 mg?" }, "answer": { "zh": "不能自行这样做。标签要求用液体整粒吞服；胶囊内的缓释结构和粉粒外观不能作为目测分半工具。需要调整时应核对准确处方、现有产品和吞咽问题。", "en": "Do not do this yourself. The label says to swallow the capsule whole with liquid; the extended-release contents and their appearance are not a visual half-measure. Any adjustment requires review of the exact prescription, available product and swallowing concern." } }, { "question": { "zh": "和 DITROPAN XL、VESIcare 或 MYRBETRIQ 能一起吃吗？", "en": "Can it be taken with DITROPAN XL, VESIcare or MYRBETRIQ?" }, "answer": { "zh": "网页不能只凭商品名决定。它们成分、作用和风险边界不同；重复抗胆碱作用、尿潴留、便秘、头晕、嗜睡、认知和跌倒风险需要结合完整药单、诊断和个人情况由专业人员核对。", "en": "The site cannot decide from brand names alone. Ingredients, actions and risk boundaries differ; duplicate anticholinergic effects, urinary retention, constipation, dizziness, drowsiness, cognition and fall risk require professional review of the complete medicine list, diagnosis and individual context." } }, { "question": { "zh": "页面有包装图，是否表示美国现在还能买到？", "en": "Does a package image mean it is currently available in the United States?" }, "answer": { "zh": "不表示。图片对应两个有日期的 30 粒瓶装 NDC，DailyMed 记录的营销终止日为 2026-07-31；Orange Book 的 RLD/RS 身份、标签档案、实时库存和购买资格是不同证据层级。", "en": "No. The images correspond to two dated 30-capsule NDCs whose DailyMed marketing end date is 31 Jul 2026. Orange Book RLD/RS identity, a label archive, real-time stock and purchasing eligibility are different evidence layers." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "dosage-forms-are-part-of-medicine-identity", "medicine-label-for-everyday-questions", "polypharmacy-safety-guide" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/detrol-la/", "en": "https://origindrug.com/en/drugs/detrol-la/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "linzess", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-29", "status": "published_traceable_archive" }, "names": { "brand": "LINZESS", "generic": "利那洛肽", "aliases": [ "Linzess", "linaclotide", "利那洛肽", "利那洛肽胶囊", "リンゼス", "リンゼス錠", "利那洛肽片", "リンゼス錠0.25mg", "NDA 202811", "0456-1203-30", "0456-1201-30", "0456-1202-30", "FL 72", "FL 145", "FL 290", "PMDA 2399017F1020" ], "marketBrandNames": [ { "name": "LINZESS", "market": { "zh": "美国", "en": "United States" }, "evidenceStatus": "current_regulatory_record", "note": { "zh": "NDA 202811；72、145、290 mcg 胶囊均为处方 RLD，72 与 145 mcg 同时为 RS；当前 SPL 提供三个 30 粒瓶装面板。", "en": "NDA 202811; 72, 145 and 290 mcg capsules are prescription RLD products, with 72 and 145 mcg also listed as RS; the current SPL provides three 30-capsule bottle panels." }, "source": { "id": "src_847563e687116eda", "label": "FDA Drugs@FDA：LINZESS NDA 202811 当前申请、RLD 与 RS 记录", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=202811", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_database_record", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } }, { "name": "Linzess Tablets 0.25 mg", "market": { "zh": "日本（官方日文名：リンゼス錠 0.25 mg）", "en": "Japan" }, "evidenceStatus": "current_regulatory_record", "note": { "zh": "PMDA 当前记录为利那洛肽 0.25 mg 薄膜衣片；不是美国胶囊产品身份。", "en": "The current PMDA record is a linaclotide 0.25 mg film-coated tablet; it is not a U.S. capsule identity." }, "source": { "id": "src_3f1cef5949e0584d", "label": "日本 PMDA：リンゼス錠 0.25 mg 当前产品、电子说明书与患者资料入口（2026-08-27）", "url": "https://www.pmda.go.jp/PmdaSearch/rdDetail/iyaku/2399017F1020_1?user=1", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } } ], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "消化系统", "sourceArchiveMarket": "美国：DailyMed 当前 SPL v39 列出 LINZESS 72、145、290 mcg 口服胶囊及三个准确 30 粒瓶装面板；FDA Orange Book 将三个规格均列为处方 RLD，并将 72 与 145 mcg 列为 RS。日本：PMDA 当前记录为リンゼス錠 0.25 mg 薄膜衣片。胶囊、片剂、mcg、mg、适应症和当地文件必须分市场核对，不能只凭利那洛肽成分自行换算或替换。", "dosageFormClass": "美国为利那洛肽 72、145、290 mcg 口服胶囊；日本为利那洛肽 0.25 mg 薄膜衣口服片。美国标签允许在吞咽困难时按指定方法打开胶囊并使用一整粒的全部内容物，但不得咀嚼、压碎、目测分半或保存混合物", "dosageFormClassCode": "oral_solid", "route": "口服（跨市场准确产品身份字段）", "routeCode": "oral", "historicalApprovalEntry": "2012-08-30（美国 FDA 初始批准）；2016-12-19（日本首次批准节点）", "archiveSponsorText": "AbbVie Inc.（FDA Orange Book 当前申请主体）；Allergan, Inc.（DailyMed 标签包装方）；アステラス製薬株式会社（日本 PMDA）" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [ "generic linaclotide capsule", "其他厂牌利那洛肽胶囊", "plecanatide", "TRULANCE", "lubiprostone", "AMITIZA", "polyethylene glycol 3350", "MiraLAX", "lactulose", "senna", "bisacodyl" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-linzess-linaclotide-72mcg-30-capsule-bottle-ndc-0456120330", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国品牌标签（SPL v39；2026-05-21 生效）", "en": "Current U.S. DailyMed brand label (SPL v39; effective 21 May 2026)" }, "dosageForm": { "zh": "LINZESS 利那洛肽口服胶囊", "en": "LINZESS linaclotide oral capsule" }, "route": { "zh": "口服（完整胶囊或标签明确的整粒内容物给药路径）", "en": "oral (whole capsule or the label-specified complete-contents route)" }, "routeCodes": [ "oral" ], "productCode": "NDC 0456-1203-30", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_capsule", "primaryDisplay": { "zh": "每粒利那洛肽 72 mcg；30 粒瓶装", "en": "Linaclotide 72 mcg per capsule; 30-capsule bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=linzess-02.jpg&id=954190", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "利那洛肽", "en": "linaclotide" }, "value": 72, "unit": "mcg", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒标签标示量；不是个人一次粒数、频率、疗程或加减量指令", "en": "labelled amount per capsule; not an individual's capsule count, frequency, duration or adjustment instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "30 粒处方药瓶装标签展示面", "en": "30-capsule prescription bottle label panel" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-29", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 30, "unit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "physicalClues": { "color": { "zh": "白色至类白色不透明", "en": "white to off-white opaque" }, "shape": { "zh": "硬明胶胶囊；无刻痕；不得咀嚼或压碎", "en": "hard gelatin capsule; unscored; do not chew or crush" }, "imprint": "FL 72", "scoreStatus": "unscored_complete_contents_only", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_cce59ece5909d96a", "label": "DailyMed（NLM）：LINZESS 利那洛肽胶囊当前美国品牌标签（SPL v39；2026-05-21 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=09beda19-56d6-4a56-afdc-9a77b70b2ef3", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-linzess-linaclotide-145mcg-30-capsule-bottle-ndc-0456120130", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国品牌标签（SPL v39；2026-05-21 生效）", "en": "Current U.S. DailyMed brand label (SPL v39; effective 21 May 2026)" }, "dosageForm": { "zh": "LINZESS 利那洛肽口服胶囊", "en": "LINZESS linaclotide oral capsule" }, "route": { "zh": "口服（完整胶囊或标签明确的整粒内容物给药路径）", "en": "oral (whole capsule or the label-specified complete-contents route)" }, "routeCodes": [ "oral" ], "productCode": "NDC 0456-1201-30", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_capsule", "primaryDisplay": { "zh": "每粒利那洛肽 145 mcg；30 粒瓶装", "en": "Linaclotide 145 mcg per capsule; 30-capsule bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=linzess-03.jpg&id=954190", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "利那洛肽", "en": "linaclotide" }, "value": 145, "unit": "mcg", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒标签标示量；不是个人一次粒数、频率、疗程或加减量指令", "en": "labelled amount per capsule; not an individual's capsule count, frequency, duration or adjustment instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "30 粒处方药瓶装标签展示面", "en": "30-capsule prescription bottle label panel" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-29", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 30, "unit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "physicalClues": { "color": { "zh": "白色至类白色不透明", "en": "white to off-white opaque" }, "shape": { "zh": "硬明胶胶囊；无刻痕；不得咀嚼或压碎", "en": "hard gelatin capsule; unscored; do not chew or crush" }, "imprint": "FL 145", "scoreStatus": "unscored_complete_contents_only", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_cce59ece5909d96a", "label": "DailyMed（NLM）：LINZESS 利那洛肽胶囊当前美国品牌标签（SPL v39；2026-05-21 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=09beda19-56d6-4a56-afdc-9a77b70b2ef3", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-linzess-linaclotide-290mcg-30-capsule-bottle-ndc-0456120230", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国品牌标签（SPL v39；2026-05-21 生效）", "en": "Current U.S. DailyMed brand label (SPL v39; effective 21 May 2026)" }, "dosageForm": { "zh": "LINZESS 利那洛肽口服胶囊", "en": "LINZESS linaclotide oral capsule" }, "route": { "zh": "口服（完整胶囊或标签明确的整粒内容物给药路径）", "en": "oral (whole capsule or the label-specified complete-contents route)" }, "routeCodes": [ "oral" ], "productCode": "NDC 0456-1202-30", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_capsule", "primaryDisplay": { "zh": "每粒利那洛肽 290 mcg；30 粒瓶装", "en": "Linaclotide 290 mcg per capsule; 30-capsule bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=linzess-04.jpg&id=954190", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "利那洛肽", "en": "linaclotide" }, "value": 290, "unit": "mcg", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒标签标示量；不是个人一次粒数、频率、疗程或加减量指令", "en": "labelled amount per capsule; not an individual's capsule count, frequency, duration or adjustment instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "30 粒处方药瓶装标签展示面", "en": "30-capsule prescription bottle label panel" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-29", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 30, "unit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "physicalClues": { "color": { "zh": "白色至类白色不透明", "en": "white to off-white opaque" }, "shape": { "zh": "硬明胶胶囊；无刻痕；不得咀嚼或压碎", "en": "hard gelatin capsule; unscored; do not chew or crush" }, "imprint": "FL 290", "scoreStatus": "unscored_complete_contents_only", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_cce59ece5909d96a", "label": "DailyMed（NLM）：LINZESS 利那洛肽胶囊当前美国品牌标签（SPL v39；2026-05-21 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=09beda19-56d6-4a56-afdc-9a77b70b2ef3", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "jp-linzess-linaclotide-0-25mg-film-coated-tablet-pmda-2399017f1020", "marketCode": "JP", "labelVersion": { "zh": "日本 PMDA 当前产品页（2026-08-27 电子说明书入口）", "en": "Current Japan PMDA product page (electronic-label route dated 27 Aug 2026)" }, "dosageForm": { "zh": "リンゼス錠 0.25 mg 利那洛肽薄膜衣口服片", "en": "Linzess linaclotide 0.25 mg film-coated oral tablet" }, "route": { "zh": "口服（日本片剂产品身份字段）", "en": "oral (Japanese tablet product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "PMDA 2399017F1020", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片利那洛肽 0.25 mg；日本薄膜衣片", "en": "Linaclotide 0.25 mg per tablet; Japanese film-coated tablet" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "利那洛肽", "en": "linaclotide" }, "value": 0.25, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；0.25 mg 等于 250 mcg 只是单位换算，不是与美国胶囊互换的依据", "en": "labelled amount per tablet; 0.25 mg equals 250 mcg as unit conversion only, not as a basis for interchange with a U.S. capsule" } } ], "concentration": null, "container": { "typeCode": "package_not_established", "typeLabel": { "zh": "本轮未建立准确公开包装图", "en": "exact public package image not established in this review" }, "fill": null, "countPerPackage": null, "countUnit": null }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-29", "currentLabelDisplayed": true, "ndcDirectoryListed": false, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "unit": { "zh": "包装数量须回到当前日本文件核对", "en": "pack count requires checking against the current Japanese document" } }, "physicalClues": { "color": { "zh": "须回到当前日本电子说明书核对", "en": "check the current Japanese electronic label" }, "shape": { "zh": "薄膜衣片，不是美国胶囊", "en": "film-coated tablet, not a U.S. capsule" }, "imprint": "not asserted", "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_3f1cef5949e0584d", "label": "日本 PMDA：リンゼス錠 0.25 mg 当前产品、电子说明书与患者资料入口（2026-08-27）", "url": "https://www.pmda.go.jp/PmdaSearch/rdDetail/iyaku/2399017F1020_1?user=1", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-linzess-linaclotide-145mcg-30-capsule-bottle-ndc-0456120130", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=linzess-03.jpg&id=954190", "alt": "LINZESS 利那洛肽 145 mcg 每粒、30 粒、NDC 0456-1201-30 的美国 DailyMed 当前包装标签展示面", "archiveMarket": "美国", "labelVersion": "DailyMed 当前 SPL v39；2026-05-21 生效", "presentation": "LINZESS 利那洛肽胶囊，每粒 145 mcg，30 粒瓶装，NDC 0456-1201-30。", "notice": "此图只对应所引美国当前标签中的 145 mcg、30 粒瓶装；不代表 72 或 290 mcg、其他包装、日本 0.25 mg 片剂、其他厂牌、其他市场或实时库存。它不用于鉴定真伪，也不生成个人粒数、频率或疗程。", "source": { "id": "src_cce59ece5909d96a", "label": "DailyMed（NLM）：LINZESS 利那洛肽胶囊当前美国品牌标签（SPL v39；2026-05-21 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=09beda19-56d6-4a56-afdc-9a77b70b2ef3", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "LINZESS 说明书放大阅读：mcg 不是粒数；可打开不等于可分半", "en": "LINZESS label reading: mcg is not a capsule count, and opening does not mean dividing" }, "summary": { "zh": "美国标签首先建议整粒吞服。吞咽困难时可以按标签指定方法打开胶囊，把一整粒的全部内容物用于苹果酱或水的路径；不得咀嚼、压碎、目测分半或把混合物留到以后。网页只解释标签边界，不替个人选择规格、频率或疗程。", "en": "The U.S. label first states to swallow the capsule whole. For swallowing difficulty, it describes opening the capsule and using the complete contents of one capsule through specified applesauce or water routes. Do not chew, crush, visually divide or store a mixture for later. The site explains label boundaries but does not choose an individual strength, frequency or duration." }, "checks": [ { "zh": "72、145、290 mcg 是每粒胶囊的标签标示量；30 是瓶内粒数。mcg（微克）不是 mg（毫克），1 mg 等于 1,000 mcg。单位换算不能替个人决定吃几粒、是否换规格或补服。", "en": "72, 145 and 290 mcg are labelled amounts per capsule, while 30 is the bottle count. A microgram (mcg) is not a milligram (mg): 1 mg equals 1,000 mcg. Unit conversion cannot decide an individual's capsule count, strength change or make-up use." }, { "zh": "标签允许的不是‘倒一半’：若按吞咽困难路径打开胶囊，必须使用一整粒的全部内容物，并按标签规定立即使用；不能咀嚼或压碎药珠，也不能凭眼睛把药珠分成两份。", "en": "The label does not permit ‘pouring out half’. If the capsule is opened through the swallowing-difficulty route, the complete contents of one capsule are used and administered immediately as specified. Do not chew or crush the beads or split them visually into portions." }, { "zh": "严重腹泻可导致脱水。明显口渴、少尿、头晕、乏力、晕厥或意识变化，尤其在老人、儿童或同时使用利尿药等情况下，需要尽快联系专业人员；严重时使用当地急救服务。", "en": "Severe diarrhoea can cause dehydration. Marked thirst, reduced urination, dizziness, weakness, fainting or mental-status change needs prompt professional help, particularly in an older person, child or someone also using a diuretic; use local emergency services when severe." }, { "zh": "已知或疑似机械性胃肠道梗阻是美国标签禁忌。持续严重腹痛、明显腹胀、反复呕吐或不能排气排便不能只当作普通便秘继续自行加药。", "en": "Known or suspected mechanical gastrointestinal obstruction is a U.S. label contraindication. Persistent severe pain, marked distension, repeated vomiting or inability to pass gas or stool must not be treated as ordinary constipation by simply adding more medicine." }, { "zh": "美国标签对 2 岁以下儿童有严重脱水黑框警告并列为禁忌。网页不会由年龄、体重或症状生成儿童用法；涉及儿童必须核对当前当地标签与负责治疗的专业人员。", "en": "The U.S. label has a boxed warning for serious dehydration and a contraindication in children under 2 years. The site does not generate paediatric use from age, weight or symptoms; current local labelling and the treating professional are required." }, { "zh": "MiraLAX、乳果糖、比沙可啶、番泻叶、镁盐、其他处方便秘药和所谓清肠产品不是同一种产品。不要因都用于排便问题就自行叠加、轮换、错开或停止；老人应把处方药、非处方药、补充剂和实际排便变化放进同一张药单核对。", "en": "MiraLAX, lactulose, bisacodyl, senna, magnesium salts, other prescription constipation medicines and bowel-cleansing products are not one product. A shared bowel-related use does not permit self-combination, alternation, time-separation or stopping. Older adults should review prescriptions, OTC products, supplements and actual bowel changes together." } ], "source": { "id": "src_cce59ece5909d96a", "label": "DailyMed（NLM）：LINZESS 利那洛肽胶囊当前美国品牌标签（SPL v39；2026-05-21 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=09beda19-56d6-4a56-afdc-9a77b70b2ef3", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "利那洛肽怎样起作用：在肠腔表面激活 GC-C，不等于所有便秘都相同", "en": "How linaclotide works: luminal GC-C activation does not make all constipation the same" }, "summary": { "zh": "美国标签把利那洛肽描述为鸟苷酸环化酶 C（GC-C）激动剂，在肠上皮腔面局部作用，增加 cGMP，并促进氯离子、碳酸氢根和肠腔液体分泌、加快转运。机制解释产品作用环节，但不能诊断便秘原因、排除梗阻或决定某位老人应选哪个规格。", "en": "The U.S. label describes linaclotide as a guanylate cyclase-C (GC-C) agonist acting locally on the luminal surface of intestinal epithelium, increasing cGMP and promoting chloride, bicarbonate and intestinal-fluid secretion with faster transit. This explains an action pathway but cannot diagnose constipation, exclude obstruction or choose a strength for an older person." }, "checks": [ { "zh": "利那洛肽与聚乙二醇 3350、乳果糖、刺激性泻药或软便剂的作用方式不同。‘都是通便药’不表示可以按微克、毫克、克或起效快慢自行换算。", "en": "Linaclotide works differently from polyethylene glycol 3350, lactulose, stimulant laxatives or stool softeners. ‘All constipation medicines’ does not permit self-conversion by micrograms, milligrams, grams or perceived speed." }, { "zh": "美国 72/145/290 mcg 胶囊和日本 0.25 mg 片剂虽含同一成分，但剂型、规格、标签适应症和给药说明不同。0.25 mg 等于 250 mcg 的算术事实不能建立可替代性。", "en": "U.S. 72/145/290 mcg capsules and the Japanese 0.25 mg tablet share an ingredient but differ in dosage form, strength, labelled indications and administration instructions. The arithmetic fact that 0.25 mg equals 250 mcg does not establish interchangeability." }, { "zh": "全基因筛查不是本站为便秘药选择设定的通用前提。实际核对更需要准确症状与诊断、梗阻警示、年龄、脱水和跌倒风险、肾脏与心血管情况、全部药物及既往反应。", "en": "Whole-genome screening is not a universal prerequisite set by this site for constipation-medicine choice. Review more directly needs the exact symptoms and diagnosis, obstruction warnings, age, dehydration and fall risk, kidney and cardiovascular context, all medicines and prior responses." } ], "source": { "id": "src_cce59ece5909d96a", "label": "DailyMed（NLM）：LINZESS 利那洛肽胶囊当前美国品牌标签（SPL v39；2026-05-21 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=09beda19-56d6-4a56-afdc-9a77b70b2ef3", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "LINZESS", "generic": "利那洛肽", "dosageFormClass": "美国为利那洛肽 72、145、290 mcg 口服胶囊；日本为利那洛肽 0.25 mg 薄膜衣口服片。美国标签允许在吞咽困难时按指定方法打开胶囊并使用一整粒的全部内容物，但不得咀嚼、压碎、目测分半或保存混合物" }, "labelSource": { "id": "src_cce59ece5909d96a", "label": "DailyMed（NLM）：LINZESS 利那洛肽胶囊当前美国品牌标签（SPL v39；2026-05-21 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=09beda19-56d6-4a56-afdc-9a77b70b2ef3", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "productRoutes": [ { "source": { "id": "src_cce59ece5909d96a", "label": "DailyMed（NLM）：LINZESS 利那洛肽胶囊当前美国品牌标签（SPL v39；2026-05-21 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=09beda19-56d6-4a56-afdc-9a77b70b2ef3", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-29", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_847563e687116eda", "label": "FDA Drugs@FDA：LINZESS NDA 202811 当前申请、RLD 与 RS 记录", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=202811", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_database_record", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-08-29", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_3f1cef5949e0584d", "label": "日本 PMDA：リンゼス錠 0.25 mg 当前产品、电子说明书与患者资料入口（2026-08-27）", "url": "https://www.pmda.go.jp/PmdaSearch/rdDetail/iyaku/2399017F1020_1?user=1", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "status": "product_level_public_record_verified", "authority": { "zh": "PMDA", "en": "PMDA" }, "market": { "zh": "日本", "en": "Japan" }, "recordType": { "zh": "监管产品记录", "en": "Regulatory product record" }, "reviewedAt": "2026-08-29", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-29", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "LINZESS 是利那洛肽的跨市场品牌档案。普通人先看三件事：美国 72、145、290 mcg 是每粒胶囊的标示量，不是一次吃几粒；吞咽困难时，美国标签允许打开胶囊，但必须按标签路径使用一整粒的全部内容物，不能倒一半；日本リンゼス是 0.25 mg 片剂，0.25 mg 等于 250 mcg 只是单位换算，不代表能替换美国胶囊。严重腹泻、脱水迹象、疑似肠梗阻或多种通便药同用需要优先核对。", "history": "FDA 资料将 LINZESS NDA 202811 的初始批准日期列为 2012-08-30；72 mcg 产品于 2017-01-25 批准。DailyMed 当前 SPL v39 于 2026-05-21 生效，并保留三种 30 粒瓶装面板。PMDA 当前产品页列示リンゼス錠 0.25 mg、电子说明书和患者资料入口。页面把文件版本、产品身份和市场分开，不把批准史写成实时供应。", "sourceDocuments": [ { "id": "src_cce59ece5909d96a", "label": "DailyMed（NLM）：LINZESS 利那洛肽胶囊当前美国品牌标签（SPL v39；2026-05-21 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=09beda19-56d6-4a56-afdc-9a77b70b2ef3", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, { "id": "src_847563e687116eda", "label": "FDA Drugs@FDA：LINZESS NDA 202811 当前申请、RLD 与 RS 记录", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=202811", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_database_record", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, { "id": "src_cc83a70818622b1c", "label": "FDA：LINZESS NDA 202811/S-022 补充批准信（2026）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/202811Orig1s022ltr.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_review", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_pdf", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, { "id": "src_a621e5729cd27f86", "label": "FDA：LINZESS NDA 202811 原始申请公开审评资料（2012）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202811Orig1s000OtherR.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_regulatory_record", "documentKind": "regulatory_review", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_pdf", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, { "id": "src_3f1cef5949e0584d", "label": "日本 PMDA：リンゼス錠 0.25 mg 当前产品、电子说明书与患者资料入口（2026-08-27）", "url": "https://www.pmda.go.jp/PmdaSearch/rdDetail/iyaku/2399017F1020_1?user=1", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } ], "applicationNumber": "FDA NDA 202811（LINZESS / linaclotide capsules）", "approvalTimeline": [ { "date": "2012-08-30", "title": { "zh": "FDA 初始批准 LINZESS", "en": "FDA initially approved LINZESS" }, "detail": { "zh": "FDA 公开资料把 145 与 290 mcg 胶囊和 NDA 202811 相连。该日期不表示当前个人应使用任何规格。", "en": "FDA public records link 145 and 290 mcg capsules to NDA 202811. The date does not indicate that any current individual should use a strength." }, "source": { "id": "src_a621e5729cd27f86", "label": "FDA：LINZESS NDA 202811 原始申请公开审评资料（2012）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202811Orig1s000OtherR.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_regulatory_record", "documentKind": "regulatory_review", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_pdf", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } }, { "date": "2017-01-25", "title": { "zh": "美国 72 mcg 产品批准节点", "en": "U.S. 72 mcg product approval node" }, "detail": { "zh": "当前 Orange Book 将 72 mcg 列为产品 003、RLD 与 RS。", "en": "The current Orange Book lists 72 mcg as product 003, RLD and RS." }, "source": { "id": "src_847563e687116eda", "label": "FDA Drugs@FDA：LINZESS NDA 202811 当前申请、RLD 与 RS 记录", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=202811", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_database_record", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } }, { "date": "2026-05-21", "title": { "zh": "DailyMed 当前 SPL v39 生效", "en": "Current DailyMed SPL v39 effective" }, "detail": { "zh": "当前标签提供三种胶囊、三个 30 粒瓶装面板、吞咽困难路径、黑框警告、腹泻和机制信息。", "en": "The current label provides three capsules, three 30-capsule bottle panels, swallowing-difficulty routes, boxed warning, diarrhoea and mechanism information." }, "source": { "id": "src_cce59ece5909d96a", "label": "DailyMed（NLM）：LINZESS 利那洛肽胶囊当前美国品牌标签（SPL v39；2026-05-21 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=09beda19-56d6-4a56-afdc-9a77b70b2ef3", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } }, { "date": "2026-08-27", "title": { "zh": "PMDA 日本产品资料更新入口", "en": "Japan PMDA product-information update route" }, "detail": { "zh": "PMDA 当前页列示リンゼス錠 0.25 mg、电子说明书和患者资料；日本片剂与美国胶囊分开呈现。", "en": "The current PMDA page lists Linzess 0.25 mg tablets, electronic labelling and patient information; the Japanese tablet is kept separate from U.S. capsules." }, "source": { "id": "src_3f1cef5949e0584d", "label": "日本 PMDA：リンゼス錠 0.25 mg 当前产品、电子说明书与患者资料入口（2026-08-27）", "url": "https://www.pmda.go.jp/PmdaSearch/rdDetail/iyaku/2399017F1020_1?user=1", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "当前处方 RLD 胶囊；72 与 145 mcg 为 RS", "en": "Current prescription RLD capsules; 72 and 145 mcg are RS" }, "detail": { "zh": "三个 30 粒瓶装面板已逐项建立。监管和包装记录不证明实时库存、购买资格、个人适用性或与其他产品可替代。", "en": "Three 30-capsule bottle panels are recorded individually. Regulatory and package records do not establish real-time stock, purchasing eligibility, individual suitability or interchangeability." } }, { "market": { "zh": "日本", "en": "Japan" }, "status": { "zh": "PMDA 当前 0.25 mg 薄膜衣片记录", "en": "Current PMDA 0.25 mg film-coated tablet record" }, "detail": { "zh": "本轮建立来源文字身份和官方电子说明书入口，未展示未经核对的包装图；不得用美国胶囊替代推断日本片剂。", "en": "This review establishes a source-text identity and official electronic-label route without showing an unverified package image; the U.S. capsule must not be used to infer the Japanese tablet." } }, { "market": { "zh": "中国大陆、欧盟及其他市场", "en": "Mainland China, EU and other markets" }, "status": { "zh": "待逐项建立现行市场记录", "en": "Current market records not established" }, "detail": { "zh": "不从美国或日本名称、同一成分或单位换算推定当地批准、剂型、包装、供应、原研/仿制关系或可替代性。", "en": "No local approval, dosage form, pack, supply, originator/generic relationship or interchangeability is inferred from U.S. or Japanese names, a shared ingredient or unit conversion." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "145 mcg 胶囊能打开倒一半，当成较小规格吗？", "en": "Can a 145 mcg capsule be opened and half used as a smaller strength?" }, "answer": { "zh": "不能自行这样做。美国标签允许打开仅是吞咽困难给药路径，并要求使用一整粒的全部内容物、不得咀嚼或压碎，也没有把目测分药珠写成减量方法。需要调整时应核对准确处方和现有产品。", "en": "Do not do this yourself. The U.S. label permits opening only as a swallowing-difficulty administration route and uses the complete contents of one capsule without chewing or crushing. It does not describe visually dividing beads as dose reduction. Any adjustment requires review of the exact prescription and available product." } }, { "question": { "zh": "日本 0.25 mg 等于 250 mcg，能换成美国 145 或 290 mcg 胶囊吗？", "en": "Does Japanese 0.25 mg equal 250 mcg and permit switching to a U.S. 145 or 290 mcg capsule?" }, "answer": { "zh": "0.25 mg 等于 250 mcg 只是单位换算。日本产品是片剂，美国产品是胶囊，规格、说明书适应症、给药说明和监管身份不同；不能据此自行换药、拼粒或跨境替代。", "en": "0.25 mg equals 250 mcg as unit conversion only. The Japanese product is a tablet and the U.S. products are capsules, with different strengths, labelled indications, administration instructions and regulatory identities. This does not permit self-switching, capsule assembly or cross-border substitution." } }, { "question": { "zh": "已经用了其他通便药，可以再加 LINZESS 吗？", "en": "Can LINZESS be added to another constipation medicine?" }, "answer": { "zh": "网页不能仅凭用途决定。多种通便药可能叠加腹泻、脱水、电解质或跌倒风险；老人还可能同时使用利尿药、降压药或影响肠动力的药。请把所有处方药、非处方药和实际症状交给药师或开方团队核对。", "en": "The site cannot decide from purpose alone. Multiple bowel medicines may compound diarrhoea, dehydration, electrolyte or fall risk, and an older person may also use diuretics, blood-pressure medicines or medicines affecting gut motility. Have all prescriptions, OTC products and actual symptoms reviewed." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "dose-units-and-concentrations", "polypharmacy-safety-guide" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/linzess/", "en": "https://origindrug.com/en/drugs/linzess/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "klor-con", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-29", "status": "published_traceable_archive" }, "names": { "brand": "KLOR-CON", "generic": "氯化钾", "aliases": [ "Klor-Con", "氯化钾缓释片", "氯化钾缓释片剂", "potassium chloride extended-release tablets", "Klor-Con 8", "Klor-Con 10", "potassium chloride", "potassium chloride extended release", "氯化钾", "KLOR-CON 8", "KLOR-CON 10", "NDA 019123", "0245-5315-11", "0245-5316-11", "KC 8", "KC 10", "8 mEq 600 mg", "10 mEq 750 mg" ], "marketBrandNames": [ { "name": "KLOR-CON", "market": { "zh": "美国", "en": "United States" }, "evidenceStatus": "current_regulatory_record", "note": { "zh": "NDA 019123；8 mEq 与 10 mEq 均为处方 RLD，10 mEq 同时为 RS；当前标签有两个准确 100 片瓶装面板。", "en": "NDA 019123; both 8 mEq and 10 mEq are prescription RLD products, with 10 mEq also listed as RS; the current label has two exact 100-tablet bottle panels." }, "source": { "id": "src_b862263240da2496", "label": "FDA Drugs@FDA：KLOR-CON NDA 019123 当前申请、RLD 与 RS 记录", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=019123", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_database_record", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } } ], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "心血管", "sourceArchiveMarket": "美国：DailyMed 当前 NDA 品牌标签列 KLOR-CON 8 mEq（600 mg 氯化钾）与 10 mEq（750 mg 氯化钾）薄膜衣缓释片及两个准确 100 片瓶装面板。FDA Orange Book 当前将两规格列为处方 RLD，并将 10 mEq 列为 RS。公开标签和 RLD 状态不证明实时库存、购买资格、个人需要补钾或可与 KLOR-CON M、溶液、粉剂、注射剂互换。", "dosageFormClass": "氯化钾蜡基质薄膜衣缓释口服片：每片 8 mEq（600 mg 氯化钾）或 10 mEq（750 mg 氯化钾）；必须整片吞服，不得压碎、咀嚼或含吮；不是 KLOR-CON M 微囊化缓释片", "dosageFormClassCode": "oral_modified_release", "route": "口服（高风险电解质准确产品身份字段）", "routeCode": "oral", "historicalApprovalEntry": "1948（当前标签所列美国初始批准）；1986-04-17（NDA 019123 准确产品批准）", "archiveSponsorText": "Upsher-Smith Laboratories, LLC（DailyMed 当前标签与 FDA Orange Book 当前申请主体）" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [ "KLOR-CON M", "Klor-Con M10", "Klor-Con M15", "Klor-Con M20", "potassium chloride oral solution", "potassium chloride powder", "potassium chloride injection" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-klor-con-potassium-chloride-8meq-600mg-100-tablet-bottle-ndc-0245531511", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国 NDA 品牌标签（SPL v6；2025-07-16 发布；处方信息 2018-10 修订）", "en": "Current U.S. DailyMed NDA brand label (SPL v6; published 16 Jul 2025; prescribing information revised Oct 2018)" }, "dosageForm": { "zh": "KLOR-CON 氯化钾薄膜衣缓释口服片", "en": "KLOR-CON potassium chloride film-coated extended-release oral tablet" }, "route": { "zh": "口服（完整缓释片产品身份字段）", "en": "oral (intact extended-release tablet product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 0245-5315-11", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片氯化钾 600 mg，相当于钾 8 mEq；100 片瓶装", "en": "Potassium chloride 600 mg, equivalent to potassium 8 mEq per tablet; 100-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=klor-con-01.jpg&setid=1ff53330-065c-4213-9c0c-ac498621d09d&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "氯化钾", "en": "potassium chloride" }, "value": 600, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片氯化钾质量；不是个人片数、频率、疗程或补服指令", "en": "potassium chloride mass per tablet; not an individual's tablet count, frequency, course or make-up instruction" } }, { "ingredient": { "zh": "钾（氯化钾所提供的电解质当量）", "en": "potassium (electrolyte equivalent supplied by potassium chloride)" }, "value": 8, "unit": "mEq", "basisCode": "per_tablet", "basisLabel": { "zh": "每片钾的毫当量；mEq 与 mg 不是可以脱离成分直接换算的同一单位", "en": "milliequivalents of potassium per tablet; mEq and mg are not one unit that can be converted without the named substance" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "100 片处方药瓶装标签展示面", "en": "100-tablet prescription bottle label panel" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-29", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "浅蓝色", "en": "light blue" }, "shape": { "zh": "圆形、无刻痕薄膜衣缓释片，约 11 mm", "en": "round, unscored film-coated extended-release tablet, approximately 11 mm" }, "imprint": "KC / 8", "scoreStatus": "unscored_swallow_whole", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_2df4fae2af71ebbe", "label": "DailyMed（NLM）：KLOR-CON 氯化钾缓释片当前美国 NDA 品牌标签（SPL v6；2025-07-16 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=1ff53330-065c-4213-9c0c-ac498621d09d", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-klor-con-potassium-chloride-10meq-750mg-100-tablet-bottle-ndc-0245531611", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国 NDA 品牌标签（SPL v6；2025-07-16 发布；处方信息 2018-10 修订）", "en": "Current U.S. DailyMed NDA brand label (SPL v6; published 16 Jul 2025; prescribing information revised Oct 2018)" }, "dosageForm": { "zh": "KLOR-CON 氯化钾薄膜衣缓释口服片", "en": "KLOR-CON potassium chloride film-coated extended-release oral tablet" }, "route": { "zh": "口服（完整缓释片产品身份字段）", "en": "oral (intact extended-release tablet product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 0245-5316-11", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片氯化钾 750 mg，相当于钾 10 mEq；100 片瓶装", "en": "Potassium chloride 750 mg, equivalent to potassium 10 mEq per tablet; 100-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=klor-con-02.jpg&setid=1ff53330-065c-4213-9c0c-ac498621d09d&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "氯化钾", "en": "potassium chloride" }, "value": 750, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片氯化钾质量；不是个人片数、频率、疗程或补服指令", "en": "potassium chloride mass per tablet; not an individual's tablet count, frequency, course or make-up instruction" } }, { "ingredient": { "zh": "钾（氯化钾所提供的电解质当量）", "en": "potassium (electrolyte equivalent supplied by potassium chloride)" }, "value": 10, "unit": "mEq", "basisCode": "per_tablet", "basisLabel": { "zh": "每片钾的毫当量；mEq 与 mg 不是可以脱离成分直接换算的同一单位", "en": "milliequivalents of potassium per tablet; mEq and mg are not one unit that can be converted without the named substance" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "100 片处方药瓶装标签展示面", "en": "100-tablet prescription bottle label panel" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-29", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "黄色", "en": "yellow" }, "shape": { "zh": "圆形、无刻痕薄膜衣缓释片，约 13 mm", "en": "round, unscored film-coated extended-release tablet, approximately 13 mm" }, "imprint": "KC / 10", "scoreStatus": "unscored_swallow_whole", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_2df4fae2af71ebbe", "label": "DailyMed（NLM）：KLOR-CON 氯化钾缓释片当前美国 NDA 品牌标签（SPL v6；2025-07-16 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=1ff53330-065c-4213-9c0c-ac498621d09d", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-klor-con-potassium-chloride-8meq-600mg-100-tablet-bottle-ndc-0245531511", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=klor-con-01.jpg&setid=1ff53330-065c-4213-9c0c-ac498621d09d&type=img", "alt": "KLOR-CON 8 mEq、每片氯化钾 600 mg、100 片、NDC 0245-5315-11 的美国 DailyMed 当前包装标签展示面", "archiveMarket": "美国", "labelVersion": "DailyMed 当前 SPL v6；2025-07-16 发布", "presentation": "KLOR-CON 氯化钾缓释片，每片 8 mEq（600 mg 氯化钾），100 片瓶装，NDC 0245-5315-11。", "notice": "此图只对应所引美国当前标签中的 8 mEq（600 mg）、100 片瓶装；不代表 10 mEq、500 片或单位剂量包装、KLOR-CON M、液体、粉剂、注射剂、其他厂牌、其他市场或实时库存。它不用于鉴定真伪，也不生成个人片数、频率或补钾方案。", "source": { "id": "src_2df4fae2af71ebbe", "label": "DailyMed（NLM）：KLOR-CON 氯化钾缓释片当前美国 NDA 品牌标签（SPL v6；2025-07-16 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=1ff53330-065c-4213-9c0c-ac498621d09d", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "KLOR-CON 说明书放大阅读：mEq 不是 mg，空壳不是补服依据", "en": "KLOR-CON label reading: mEq is not mg, and an empty matrix is not a reason to repeat" }, "summary": { "zh": "8 mEq（600 mg）和 10 mEq（750 mg）分别把钾的电解质当量与氯化钾质量写在同一药盒上。当前 KLOR-CON 标签要求整片吞服，不得压碎、咀嚼或含吮。蜡基质可能在粪便中看起来像空壳，这不表示药物没吸收，也不能自行补一片。", "en": "The 8 mEq (600 mg) and 10 mEq (750 mg) labels place the potassium electrolyte equivalent and potassium chloride mass on the same pack. The current KLOR-CON label says to swallow the tablet whole without crushing, chewing or sucking. Its wax matrix may be visible in stool; that does not prove failed absorption and is not a reason to repeat a tablet." }, "checks": [ { "zh": "mEq（毫当量）描述特定离子的电解质当量；mg 描述特定物质的质量。8 mEq 对应本产品每片 600 mg 氯化钾，10 mEq 对应 750 mg 氯化钾，但不能把这个关系拿去换算其他成分、液体浓度、注射剂或个人片数。", "en": "mEq describes the electrolyte equivalent of a named ion, while mg describes the mass of a named substance. In this product, 8 mEq corresponds to 600 mg potassium chloride per tablet and 10 mEq to 750 mg, but that relationship must not be transferred to another ingredient, liquid concentration, injection or personal tablet count." }, { "zh": "本档案的 KLOR-CON 是蜡基质、无刻痕缓释片，标签要求整片吞服。不得因想减半就压碎、咀嚼、含吮或自行掰分。名称相近的 KLOR-CON M 是不同微囊化制剂，其标签中的掰分或水分散路径不能套用于本产品。", "en": "This dossier covers an unscored wax-matrix KLOR-CON extended-release tablet whose label says to swallow whole. Do not crush, chew, suck or divide it to make a smaller amount. Similarly named KLOR-CON M is a different microencapsulated formulation, and its splitting or water-dispersion route must not be transferred to this product." }, { "zh": "氨苯蝶啶或阿米洛利同用在当前标签中属于禁忌。ACE 抑制剂、ARB、螺内酯、依普利酮、阿利吉仑及 NSAID 也可能增加高钾风险；不要因都在一张药单上就自行停某一种，应尽快让药师或临床医生核对血钾、肾功能和完整药单。", "en": "Current labelling contraindicates co-use with triamterene or amiloride. ACE inhibitors, ARBs, spironolactone, eplerenone, aliskiren and NSAIDs may also increase hyperkalaemia risk. Do not stop a medicine yourself because both appear on a list; obtain prompt review of potassium, kidney function and the complete medicine list." }, { "zh": "老年人更常见肾、心脏功能下降和多种药同用；高钾有时早期没有明显症状。网页不能从药盒或感觉判断血钾，也不能用香蕉、补充剂或含钾盐替代化验和专业评估。", "en": "Older adults more often have reduced kidney or cardiac function and multiple medicines, while hyperkalaemia may initially have no obvious symptoms. A pack or symptom cannot tell this site the potassium level, and bananas, supplements or potassium-containing salt substitutes do not replace laboratory and professional assessment." }, { "zh": "严重呕吐、持续或剧烈腹痛、明显腹胀、黑便或消化道出血需要及时医疗评估；严重胸部不适、晕厥、显著肌无力或心律异常感应使用当地急救服务。网页不等待这些症状自行消退，也不从症状推断个人补钾量。", "en": "Severe vomiting, persistent or severe abdominal pain, marked distension, black stools or gastrointestinal bleeding need timely medical assessment. Severe chest symptoms, fainting, marked muscle weakness or a sense of abnormal rhythm warrants local emergency care. The site does not wait for these symptoms to resolve or infer a personal potassium amount from them." }, { "zh": "粪便中可能看到未吸收的蜡基质空壳；这与 GLUCOTROL XL 等其他缓释系统同样强调‘外壳可见不等于漏吸收’，但不同产品不能因此合并、替换或重复服用。", "en": "The unabsorbed wax matrix may be visible in stool. Like the empty-shell literacy of some other extended-release systems such as GLUCOTROL XL, a visible shell does not mean failed absorption, but the products must not be merged, substituted or repeated on that basis." } ], "source": { "id": "src_2df4fae2af71ebbe", "label": "DailyMed（NLM）：KLOR-CON 氯化钾缓释片当前美国 NDA 品牌标签（SPL v6；2025-07-16 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=1ff53330-065c-4213-9c0c-ac498621d09d", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "氯化钾怎样起作用：补充钾离子，不等于看到利尿药就自动补钾", "en": "How potassium chloride works: replenishing potassium does not mean automatically adding it to a diuretic" }, "summary": { "zh": "钾是细胞内主要阳离子，参与神经冲动传导、心肌和骨骼肌收缩以及肾功能。KLOR-CON 的蜡基质延缓局部释放，钾在小肠离开前被吸收，基质本身不吸收。机制说明为什么需要血钾、肾功能和药物联用信息，却不能替个人决定是否补钾或吃几片。", "en": "Potassium is a principal intracellular cation involved in nerve transmission, cardiac and skeletal-muscle contraction and renal function. KLOR-CON uses a wax matrix to slow local release; potassium is absorbed before leaving the small intestine while the matrix itself is not absorbed. This mechanism explains why potassium, kidney function and co-medications matter, but cannot decide whether an individual needs supplementation or how many tablets to take." }, "checks": [ { "zh": "袢利尿药或噻嗪类药可能影响钾，但保钾利尿药、ACEI、ARB、ARNI、螺内酯、NSAID、肾功能变化和饮食补充剂又可能把风险推向另一方向。不能仅凭‘用了利尿药’就自动加 KLOR-CON。", "en": "Loop or thiazide diuretics may affect potassium, while potassium-sparing diuretics, ACE inhibitors, ARBs, ARNIs, spironolactone, NSAIDs, kidney-function changes and supplements may shift risk in another direction. ‘Taking a diuretic’ alone does not permit automatically adding KLOR-CON." }, { "zh": "8 mEq/600 mg 与 10 mEq/750 mg 是两个准确产品强度；mEq 不等同于片数。网页不把化验值、体重、利尿药剂量或每日摄入换成个人片数，也不提供漏服补服算法。", "en": "8 mEq/600 mg and 10 mEq/750 mg are two exact product strengths; mEq is not a tablet count. The site does not convert a laboratory value, body weight, diuretic amount or daily intake into a personal tablet count and provides no missed-use algorithm." }, { "zh": "全基因筛查不是本站为常规补钾设定的通用前提。更直接的核对信息通常包括准确产品、血钾趋势、肾功能、心电图与临床状态、酸碱和其他电解质，以及完整药单。", "en": "Whole-genome screening is not a universal prerequisite set by this site for routine potassium supplementation. More directly relevant review usually includes the exact product, potassium trend, kidney function, ECG and clinical status, acid-base and other electrolytes, and the complete medicine list." } ], "source": { "id": "src_2df4fae2af71ebbe", "label": "DailyMed（NLM）：KLOR-CON 氯化钾缓释片当前美国 NDA 品牌标签（SPL v6；2025-07-16 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=1ff53330-065c-4213-9c0c-ac498621d09d", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "KLOR-CON", "generic": "氯化钾", "dosageFormClass": "氯化钾蜡基质薄膜衣缓释口服片：每片 8 mEq（600 mg 氯化钾）或 10 mEq（750 mg 氯化钾）；必须整片吞服，不得压碎、咀嚼或含吮；不是 KLOR-CON M 微囊化缓释片" }, "labelSource": { "id": "src_2df4fae2af71ebbe", "label": "DailyMed（NLM）：KLOR-CON 氯化钾缓释片当前美国 NDA 品牌标签（SPL v6；2025-07-16 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=1ff53330-065c-4213-9c0c-ac498621d09d", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "productRoutes": [ { "source": { "id": "src_2df4fae2af71ebbe", "label": "DailyMed（NLM）：KLOR-CON 氯化钾缓释片当前美国 NDA 品牌标签（SPL v6；2025-07-16 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=1ff53330-065c-4213-9c0c-ac498621d09d", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-29", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_b862263240da2496", "label": "FDA Drugs@FDA：KLOR-CON NDA 019123 当前申请、RLD 与 RS 记录", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=019123", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_database_record", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-08-29", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_902e9a72d4fa6ba6", "label": "DailyMed（NLM）：KLOR-CON M 微囊化氯化钾缓释片当前美国标签（用于严格区分制剂）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b89910f6-4ff5-4a62-8269-696f7c10e4f6", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-29", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-29", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "KLOR-CON 是氯化钾蜡基质缓释片。药盒上的 8 mEq（600 mg）或 10 mEq（750 mg）不是两个可以任选的剂量写法：mEq 表示钾的电解质当量，mg 表示氯化钾质量，两者必须连同成分一起读。该缓释片要整片吞服，不能把 KLOR-CON M 的掰分或水分散说明套过来。老人若同时使用 ACEI、ARB、螺内酯、氨苯蝶啶、阿米洛利或 NSAID，更需要把肾功能、血钾和完整药单一起核对。", "history": "当前 FDA 标签把 KLOR-CON 的美国初始批准年份列为 1948；准确 NDA 019123 的 8 mEq 与 10 mEq Klor-Con 产品于 1986-04-17 获批。DailyMed 当前 SPL v6 于 2025-07-16 发布，并展示 8 mEq/600 mg 与 10 mEq/750 mg 两个 100 片瓶装面板。页面把历史、当前标签、包装和 Orange Book 身份分开呈现。", "sourceDocuments": [ { "id": "src_2df4fae2af71ebbe", "label": "DailyMed（NLM）：KLOR-CON 氯化钾缓释片当前美国 NDA 品牌标签（SPL v6；2025-07-16 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=1ff53330-065c-4213-9c0c-ac498621d09d", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, { "id": "src_b862263240da2496", "label": "FDA Drugs@FDA：KLOR-CON NDA 019123 当前申请、RLD 与 RS 记录", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=019123", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_database_record", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, { "id": "src_018f1dfad470f546", "label": "FDA：KLOR-CON NDA 019123 原始审评资料（1986）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/NDA/pre96/019123_s000.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_regulatory_record", "documentKind": "regulatory_review", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_pdf", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, { "id": "src_902e9a72d4fa6ba6", "label": "DailyMed（NLM）：KLOR-CON M 微囊化氯化钾缓释片当前美国标签（用于严格区分制剂）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b89910f6-4ff5-4a62-8269-696f7c10e4f6", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } ], "applicationNumber": "FDA NDA 019123（KLOR-CON potassium chloride extended-release tablets）", "approvalTimeline": [ { "date": "1948", "title": { "zh": "当前标签所列美国初始批准年份", "en": "U.S. initial-approval year stated in the current label" }, "detail": { "zh": "这是当前标签的历史起点字段，不单独证明 NDA 019123 两个准确产品的批准日、当前供应或个人适用性。", "en": "This is a historical initial-approval field in the current label; alone it does not establish the approval date of the two exact NDA 019123 products, current supply or individual suitability." }, "source": { "id": "src_2df4fae2af71ebbe", "label": "DailyMed（NLM）：KLOR-CON 氯化钾缓释片当前美国 NDA 品牌标签（SPL v6；2025-07-16 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=1ff53330-065c-4213-9c0c-ac498621d09d", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } }, { "date": "1986-04-17", "title": { "zh": "FDA 批准 NDA 019123 的 KLOR-CON 8/10 mEq", "en": "FDA approved KLOR-CON 8/10 mEq under NDA 019123" }, "detail": { "zh": "FDA 原始审评资料与当前 Orange Book 将蜡基质缓释片、8/10 mEq 产品和该 NDA 相连。", "en": "FDA original-review material and the current Orange Book connect the wax-matrix extended-release 8/10 mEq products with this NDA." }, "source": { "id": "src_018f1dfad470f546", "label": "FDA：KLOR-CON NDA 019123 原始审评资料（1986）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/NDA/pre96/019123_s000.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_regulatory_record", "documentKind": "regulatory_review", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_pdf", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } }, { "date": "2025-07-16", "title": { "zh": "DailyMed 当前 SPL v6 发布", "en": "Current DailyMed SPL v6 published" }, "detail": { "zh": "当前记录展示两个准确 100 片瓶装面板、mEq/mg、整片吞服、空壳、肾功能、胃肠道和联用边界。", "en": "The current record displays two exact 100-tablet bottle panels and the mEq/mg, intact-tablet, empty-matrix, kidney, gastrointestinal and co-medication boundaries." }, "source": { "id": "src_2df4fae2af71ebbe", "label": "DailyMed（NLM）：KLOR-CON 氯化钾缓释片当前美国 NDA 品牌标签（SPL v6；2025-07-16 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=1ff53330-065c-4213-9c0c-ac498621d09d", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "当前处方 RLD 缓释片；10 mEq 为 RS", "en": "Current prescription RLD extended-release tablets; 10 mEq is RS" }, "detail": { "zh": "两个 100 片瓶装面板已逐项建立。监管与包装记录不证明实时库存、购买资格、个人适用性或与其他氯化钾制剂可替代。", "en": "Two 100-tablet bottle panels are recorded individually. Regulatory and package records do not establish real-time stock, purchasing eligibility, individual suitability or interchangeability with another potassium chloride formulation." } }, { "market": { "zh": "中国大陆、欧盟、日本及其他市场", "en": "Mainland China, EU, Japan and other markets" }, "status": { "zh": "待逐项建立现行市场记录", "en": "Current market records not established" }, "detail": { "zh": "不从美国品牌名、相同成分、mEq/mg 数字或包装颜色推定当地批准、剂型、供应、原研/仿制关系或可替代性。", "en": "No local approval, dosage form, supply, originator/generic relationship or interchangeability is inferred from a U.S. brand name, shared ingredient, mEq/mg figures or pack colour." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "8 mEq（600 mg）是不是表示一片里有 608 mg？", "en": "Does 8 mEq (600 mg) mean the tablet contains 608 mg?" }, "answer": { "zh": "不是相加关系。600 mg 是每片氯化钾质量，8 mEq 是该氯化钾所提供钾离子的电解质当量；它们是同一产品强度的两种计量描述，不应相加，也不能脱离成分换算其他药。", "en": "No. The 600 mg is the potassium chloride mass per tablet, while 8 mEq is the electrolyte equivalent of potassium supplied by it. They are two measurements describing one product strength, not numbers to add or transfer to another medicine." } }, { "question": { "zh": "缓释片太大，能掰一半或泡水吗？", "en": "The extended-release tablet is large. Can it be halved or dispersed in water?" }, "answer": { "zh": "本档案对应的 KLOR-CON 蜡基质片无刻痕，当前标签要求整片吞服并明确不得压碎、咀嚼或含吮。不要把 KLOR-CON M 的不同说明套用过来；有吞咽困难应联系药师或开方团队核对合适的准确制剂。", "en": "This dossier covers an unscored wax-matrix KLOR-CON tablet whose current label says to swallow whole and not crush, chew or suck. Do not transfer different KLOR-CON M instructions. A swallowing difficulty requires review of the exact suitable formulation with a pharmacist or prescriber." } }, { "question": { "zh": "已经吃螺内酯或沙坦类药，还能一起吃吗？", "en": "Can it be taken with spironolactone or an ARB?" }, "answer": { "zh": "网页不能仅凭药名决定。当前标签提示 RAAS 抑制剂会增加钾潴留风险，需要密切监测；氨苯蝶啶和阿米洛利同用更属于标签禁忌。请不要自行停药或加药，应让专业人员结合血钾、肾功能和完整药单处理。", "en": "The site cannot decide from names alone. Current labelling says RAAS inhibitors increase potassium-retention risk and require close monitoring; co-use with triamterene or amiloride is contraindicated. Do not stop or add a medicine yourself; professional review needs potassium, kidney function and the complete medicine list." } } ], "relatedMedicineChecks": [ { "target": { "id": "aldactone", "brand": "Aldactone", "generic": "螺内酯", "canonicalUrls": { "zh": "https://origindrug.com/drugs/aldactone/", "en": "https://origindrug.com/en/drugs/aldactone/" } }, "title": { "zh": "与 ALDACTONE／螺内酯同在药单上时：先核对血钾、肾功能与完整药单", "en": "When ALDACTONE / spironolactone is on the same list: review potassium, kidney function and the complete medicine list first" }, "summary": { "zh": "当前 KLOR-CON 标签把螺内酯列为可能增加高钾血症风险的药物。请把两盒药、全部处方药与非处方药、补充剂、含钾盐替代品及近期血钾和肾功能结果一起交给药师或开方团队核对。本卡片不判断能否同用，也不建议自行停用、错开时间、替换或调整任何一种药。", "en": "The current KLOR-CON label identifies spironolactone as a medicine that may increase hyperkalaemia risk. Bring both packs, all prescription and nonprescription medicines, supplements, potassium-containing salt substitutes and recent potassium and kidney-function results to a pharmacist or prescribing team. This card does not decide co-use or advise self-stopping, time-separation, replacement or adjustment of either medicine." }, "source": { "id": "src_2df4fae2af71ebbe", "label": "DailyMed（NLM）：KLOR-CON 氯化钾缓释片当前美国 NDA 品牌标签（SPL v6；2025-07-16 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=1ff53330-065c-4213-9c0c-ac498621d09d", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "review_complete_medicine_list_no_self_directed_change" } ], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "dose-units-and-concentrations", "polypharmacy-safety-guide" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/klor-con/", "en": "https://origindrug.com/en/drugs/klor-con/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "depakote", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-29", "status": "published_traceable_archive" }, "names": { "brand": "DEPAKOTE", "generic": "双丙戊酸钠延迟释放片", "aliases": [ "Depakote", "双丙戊酸钠延迟释放片", "双丙戊酸钠肠溶片", "divalproex sodium delayed-release tablets", "divalproex sodium", "divalproex sodium delayed release", "双丙戊酸钠", "NDA 018723", "0074-7325-13", "0074-7326-13", "0074-7327-13" ], "marketBrandNames": [ { "name": "DEPAKOTE", "market": { "zh": "美国", "en": "United States" }, "evidenceStatus": "current_regulatory_record", "note": { "zh": "NDA 018723；125/250/500 mg 均为处方 RLD，500 mg 同时为 RS；当前标签展示三个准确 100 片瓶装面板。", "en": "NDA 018723; 125/250/500 mg are prescription RLD products and 500 mg is also the RS; the current label displays three exact 100-tablet bottle panels." }, "source": { "id": "src_10f9fa31428b78fd", "label": "FDA Drugs@FDA：DEPAKOTE NDA 018723 当前申请、RLD 与 RS 记录", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=018723", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_database_record", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } } ], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "神经与认知", "sourceArchiveMarket": "美国：DailyMed 当前 NDA 品牌标签列 DEPAKOTE 125、250、500 mg 延迟释放片及三个准确 100 片瓶装面板。FDA Orange Book 将三个规格列为处方 RLD，并将 500 mg 列为 RS。公开标签和 RLD 状态不证明实时库存、个人适用性、个人剂量，亦不证明与 DEPAKOTE ER、Sprinkle 胶囊、丙戊酸胶囊或其他丙戊酸盐可直接互换。", "dosageFormClass": "双丙戊酸钠延迟释放片：每片以丙戊酸活性计 125、250 或 500 mg；必须整片吞服，不得压碎或咀嚼；不是 DEPAKOTE ER 缓释片，也不是 DEPAKOTE Sprinkle 延迟释放胶囊", "dosageFormClassCode": "oral_modified_release", "route": "口服（高风险延迟释放片准确产品身份字段）", "routeCode": "oral", "historicalApprovalEntry": "1983-03-10（250/500 mg）；1984-10-26（125 mg）", "archiveSponsorText": "AbbVie Inc.（DailyMed 当前标签与 FDA Orange Book 当前申请主体）" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [ "DEPAKOTE ER", "DEPAKOTE Sprinkle", "divalproex sodium extended-release tablets", "divalproex sodium delayed-release capsules", "valproic acid capsules", "sodium valproate injection" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-depakote-divalproex-sodium-delayed-release-125mg-100-tablet-bottle-ndc-0074732513", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国 NDA 品牌标签（2026-03-31 更新）", "en": "Current U.S. DailyMed NDA brand label (updated 31 Mar 2026)" }, "dosageForm": { "zh": "DEPAKOTE 双丙戊酸钠延迟释放口服片", "en": "DEPAKOTE divalproex sodium delayed-release oral tablet" }, "route": { "zh": "口服（完整延迟释放片产品身份字段）", "en": "oral (intact delayed-release tablet product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 0074-7325-13", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片相当于丙戊酸 125 mg；100 片瓶装", "en": "Equivalent to valproic acid 125 mg per tablet; 100-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=depakote-tablets-spl-07.jpg&setid=08a65cf4-7749-4ceb-6895-8f4805e2b01f", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "双丙戊酸钠（以丙戊酸活性计）", "en": "divalproex sodium (as valproic acid activity)" }, "value": 125, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签强度；不是个人片数、频次、疗程、换药或血药浓度换算", "en": "label strength per tablet; not an individual's tablet count, frequency, course, switch or plasma-level conversion" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "100 片处方药瓶装标签展示面", "en": "100-tablet prescription bottle label panel" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-29", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "鲑粉色", "en": "salmon pink" }, "shape": { "zh": "椭圆形、无刻痕延迟释放片", "en": "oval, unscored delayed-release tablet" }, "imprint": "NT", "scoreStatus": "unscored_swallow_whole", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_2b4dba40298b6fdc", "label": "DailyMed（NLM）：DEPAKOTE 双丙戊酸钠延迟释放片当前美国 NDA 品牌标签（2026-03-31 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=08a65cf4-7749-4ceb-6895-8f4805e2b01f", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-depakote-divalproex-sodium-delayed-release-250mg-100-tablet-bottle-ndc-0074732613", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国 NDA 品牌标签（2026-03-31 更新）", "en": "Current U.S. DailyMed NDA brand label (updated 31 Mar 2026)" }, "dosageForm": { "zh": "DEPAKOTE 双丙戊酸钠延迟释放口服片", "en": "DEPAKOTE divalproex sodium delayed-release oral tablet" }, "route": { "zh": "口服（完整延迟释放片产品身份字段）", "en": "oral (intact delayed-release tablet product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 0074-7326-13", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片相当于丙戊酸 250 mg；100 片瓶装", "en": "Equivalent to valproic acid 250 mg per tablet; 100-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=depakote-tablets-spl-0c.jpg&setid=08a65cf4-7749-4ceb-6895-8f4805e2b01f", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "双丙戊酸钠（以丙戊酸活性计）", "en": "divalproex sodium (as valproic acid activity)" }, "value": 250, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签强度；不是个人片数、频次、疗程、换药或血药浓度换算", "en": "label strength per tablet; not an individual's tablet count, frequency, course, switch or plasma-level conversion" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "100 片处方药瓶装标签展示面", "en": "100-tablet prescription bottle label panel" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-29", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "桃色", "en": "peach" }, "shape": { "zh": "椭圆形、无刻痕延迟释放片", "en": "oval, unscored delayed-release tablet" }, "imprint": "NR", "scoreStatus": "unscored_swallow_whole", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_2b4dba40298b6fdc", "label": "DailyMed（NLM）：DEPAKOTE 双丙戊酸钠延迟释放片当前美国 NDA 品牌标签（2026-03-31 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=08a65cf4-7749-4ceb-6895-8f4805e2b01f", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-depakote-divalproex-sodium-delayed-release-500mg-100-tablet-bottle-ndc-0074732713", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国 NDA 品牌标签（2026-03-31 更新）", "en": "Current U.S. DailyMed NDA brand label (updated 31 Mar 2026)" }, "dosageForm": { "zh": "DEPAKOTE 双丙戊酸钠延迟释放口服片", "en": "DEPAKOTE divalproex sodium delayed-release oral tablet" }, "route": { "zh": "口服（完整延迟释放片产品身份字段）", "en": "oral (intact delayed-release tablet product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 0074-7327-13", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片相当于丙戊酸 500 mg；100 片瓶装", "en": "Equivalent to valproic acid 500 mg per tablet; 100-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=depakote-tablets-spl-0b.jpg&setid=08a65cf4-7749-4ceb-6895-8f4805e2b01f", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "双丙戊酸钠（以丙戊酸活性计）", "en": "divalproex sodium (as valproic acid activity)" }, "value": 500, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签强度；不是个人片数、频次、疗程、换药或血药浓度换算", "en": "label strength per tablet; not an individual's tablet count, frequency, course, switch or plasma-level conversion" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "100 片处方药瓶装标签展示面", "en": "100-tablet prescription bottle label panel" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-29", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "淡紫色", "en": "lavender" }, "shape": { "zh": "椭圆形、无刻痕延迟释放片", "en": "oval, unscored delayed-release tablet" }, "imprint": "NS", "scoreStatus": "unscored_swallow_whole", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_2b4dba40298b6fdc", "label": "DailyMed（NLM）：DEPAKOTE 双丙戊酸钠延迟释放片当前美国 NDA 品牌标签（2026-03-31 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=08a65cf4-7749-4ceb-6895-8f4805e2b01f", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-depakote-divalproex-sodium-delayed-release-125mg-100-tablet-bottle-ndc-0074732513", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=depakote-tablets-spl-07.jpg&setid=08a65cf4-7749-4ceb-6895-8f4805e2b01f", "alt": "DEPAKOTE 125 mg、100 片、NDC 0074-7325-13 的美国 DailyMed 当前包装标签展示面", "archiveMarket": "美国", "labelVersion": "DailyMed 当前标签；2026-03-31 更新", "presentation": "DEPAKOTE 双丙戊酸钠延迟释放片，每片相当于丙戊酸 125 mg，100 片瓶装，NDC 0074-7325-13。", "notice": "此图只对应所引美国当前标签中的 125 mg、100 片瓶装；不代表 250/500 mg、DEPAKOTE ER、Sprinkle 胶囊、其他丙戊酸产品、其他市场或实时库存。它不用于鉴定真伪，也不生成个人片数、频率、换药或漏服方案。", "source": { "id": "src_2b4dba40298b6fdc", "label": "DailyMed（NLM）：DEPAKOTE 双丙戊酸钠延迟释放片当前美国 NDA 品牌标签（2026-03-31 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=08a65cf4-7749-4ceb-6895-8f4805e2b01f", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "DEPAKOTE 说明书放大阅读：相同 mg 不等于相同剂型", "en": "DEPAKOTE label reading: the same mg does not mean the same dosage form" }, "summary": { "zh": "本页只对应延迟释放片。125、250 和 500 mg 都是每片以丙戊酸活性计的标签强度；三种片剂均需整片吞服，不得压碎或咀嚼。DEPAKOTE ER 是另一种缓释片，Sprinkle 是可撒服的延迟释放胶囊，不能把它们的说明套到本页产品。", "en": "This page covers delayed-release tablets only. The 125, 250 and 500 mg figures are label strengths per tablet expressed as valproic acid activity; all three tablets must be swallowed whole and not crushed or chewed. DEPAKOTE ER is a different extended-release tablet and Sprinkle is a delayed-release capsule that may be sprinkled, so their instructions must not be transferred to this product." }, "checks": [ { "zh": "mg 是每片强度，不是一天总量、血药浓度或片数。药盒同样写 500 mg，也不能据此把 DEPAKOTE 延迟释放片与 DEPAKOTE ER 缓释片一比一自行替换；任何剂型或联用变化都应结合临床状态与丙戊酸血药浓度监测。", "en": "The mg figure is strength per tablet, not a daily total, plasma concentration or tablet count. A shared 500 mg label does not permit one-for-one self-substitution between DEPAKOTE delayed-release and DEPAKOTE ER extended-release tablets; any formulation or co-medication change requires clinical and valproate-level review." }, { "zh": "DEPAKOTE 延迟释放片无刻痕，标签要求整片吞服，不能为‘吃一半’而压碎、咀嚼或自行掰分。吞咽困难应先核对准确处方和剂型；不能擅自改用 Sprinkle、ER 或液体。", "en": "DEPAKOTE delayed-release tablets are unscored and the label says to swallow whole. Do not crush, chew or divide one to make ‘half’. A swallowing difficulty requires review of the exact prescription and dosage form, not an unreviewed switch to Sprinkle, ER or a liquid." }, { "zh": "黑框警告包括可能致命的肝毒性、胎儿风险和胰腺炎。持续或剧烈腹痛伴恶心呕吐、明显黄疸或异常乏力、意识改变等需要及时医疗评估；网页不等待症状自行消失。", "en": "The boxed warning includes potentially fatal hepatotoxicity, fetal risk and pancreatitis. Persistent or severe abdominal pain with nausea or vomiting, marked jaundice or unusual fatigue, or altered awareness needs timely medical assessment; the site does not wait for symptoms to resolve." }, { "zh": "老人对嗜睡可能更敏感，且游离药物比例可能更高。出现过度嗜睡、进食或饮水减少、脱水、跌倒、步态或意识变化时，应尽快联系专业人员并带上完整药单，不要自行停药或骤减。", "en": "Older adults may be more sensitive to somnolence and may have a higher unbound drug fraction. Excessive sleepiness, reduced food or fluid intake, dehydration, falls, gait or awareness changes require prompt professional review with the complete medicine list; do not stop or sharply reduce treatment yourself." }, { "zh": "碳青霉烯类抗菌药可能显著降低丙戊酸浓度；托吡酯同用与高氨血症/脑病相关；拉莫三嗪、阿司匹林及抗凝或抗血小板药也需要逐项核对。网页不建议靠错开时间自行解决。", "en": "Carbapenem antibiotics may markedly reduce valproate concentrations; concomitant topiramate is associated with hyperammonaemia/encephalopathy; lamotrigine, aspirin, anticoagulants and antiplatelets also require item-by-item review. The site does not advise solving these interactions by self-separating times." }, { "zh": "妊娠或可能妊娠涉及重大胎儿风险，但用于癫痫时突然停用也可能引发持续状态。应立即通过开方团队或当地医疗服务获得个体化评估；网页不替代避孕、孕前或孕期专科咨询，也不指示突然停药。", "en": "Pregnancy or possible pregnancy carries major fetal risk, while abrupt withdrawal in epilepsy may precipitate status epilepticus. Obtain individual review promptly through the prescribing team or local medical service; the site does not replace contraception, preconception or pregnancy specialist counselling and does not direct abrupt withdrawal." } ], "source": { "id": "src_2b4dba40298b6fdc", "label": "DailyMed（NLM）：DEPAKOTE 双丙戊酸钠延迟释放片当前美国 NDA 品牌标签（2026-03-31 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=08a65cf4-7749-4ceb-6895-8f4805e2b01f", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "双丙戊酸钠怎样起作用：影响神经兴奋性，不是用症状直接换算片数", "en": "How divalproex works: changing neuronal excitability does not convert symptoms into tablets" }, "summary": { "zh": "双丙戊酸钠在胃肠道中解离为丙戊酸离子。其抗癫痫作用机制尚未完全确定，通常认为与提高脑内抑制性神经递质 GABA 水平有关。蛋白结合、年龄、肝肾状态及其他药物会影响总浓度与游离药物，因此同一个化验数字也不能由网页直接换成个人片数。", "en": "Divalproex sodium dissociates to valproate ion in the gastrointestinal tract. Its antiepileptic mechanism is not fully established and is commonly thought to relate to increased brain concentrations of the inhibitory neurotransmitter GABA. Protein binding, age, liver or kidney status and other medicines affect total and unbound drug, so a laboratory number cannot be converted by this site into an individual's tablet count." }, "checks": [ { "zh": "延迟释放、缓释和胶囊撒服描述释放结构与使用方式，不等同于‘更强’或‘更弱’。不能仅按总毫克数自行轮换、叠加或替换。", "en": "Delayed release, extended release and sprinkle capsules describe release structure and use, not ‘stronger’ or ‘weaker’. Total milligrams alone do not permit self-alternation, combination or substitution." }, { "zh": "血药浓度通常需要与临床状态、采血时间、白蛋白、肝肾功能、血细胞和完整药单一起解释；老人或低白蛋白状态下总浓度可能低估游离药物。", "en": "A plasma concentration is interpreted with clinical status, sampling time, albumin, liver and kidney function, blood counts and the complete medicine list; in older adults or low-albumin states, total concentration may understate unbound drug." }, { "zh": "并非每个人都需要全基因筛查；但现行标签明确把已知 POLG 相关线粒体病列为重要禁忌，并提示特定病史时评估尿素循环障碍。是否检测由专业团队根据年龄、病史、症状和用途决定。", "en": "Not everyone needs whole-genome screening. Current labelling identifies known POLG-related mitochondrial disease as an important contraindication and advises assessment for urea-cycle disorders in selected histories. Testing decisions belong to the clinical team based on age, history, symptoms and indication." } ], "source": { "id": "src_2b4dba40298b6fdc", "label": "DailyMed（NLM）：DEPAKOTE 双丙戊酸钠延迟释放片当前美国 NDA 品牌标签（2026-03-31 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=08a65cf4-7749-4ceb-6895-8f4805e2b01f", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "DEPAKOTE", "generic": "双丙戊酸钠延迟释放片", "dosageFormClass": "双丙戊酸钠延迟释放片：每片以丙戊酸活性计 125、250 或 500 mg；必须整片吞服，不得压碎或咀嚼；不是 DEPAKOTE ER 缓释片，也不是 DEPAKOTE Sprinkle 延迟释放胶囊" }, "labelSource": { "id": "src_2b4dba40298b6fdc", "label": "DailyMed（NLM）：DEPAKOTE 双丙戊酸钠延迟释放片当前美国 NDA 品牌标签（2026-03-31 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=08a65cf4-7749-4ceb-6895-8f4805e2b01f", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "productRoutes": [ { "source": { "id": "src_2b4dba40298b6fdc", "label": "DailyMed（NLM）：DEPAKOTE 双丙戊酸钠延迟释放片当前美国 NDA 品牌标签（2026-03-31 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=08a65cf4-7749-4ceb-6895-8f4805e2b01f", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-29", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_10f9fa31428b78fd", "label": "FDA Drugs@FDA：DEPAKOTE NDA 018723 当前申请、RLD 与 RS 记录", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=018723", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_database_record", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-08-29", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_190da96627768ce2", "label": "DailyMed（NLM）：DEPAKOTE ER 双丙戊酸钠缓释片当前美国标签（用于严格区分剂型）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=3a7ec88a-3379-4376-b49a-f60ae8b09fd0", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-29", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_fe82ece6945b8032", "label": "DailyMed（NLM）：DEPAKOTE Sprinkle 双丙戊酸钠延迟释放胶囊当前美国标签（用于严格区分剂型）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=4619aff4-0f80-444f-858d-42e4137aa809", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-29", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-29", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "DEPAKOTE 是双丙戊酸钠延迟释放片，药盒上的 125、250 或 500 mg 指每片以丙戊酸活性计的强度，不是一天总量，也不能用相同 mg 自行替换 DEPAKOTE ER 或 Sprinkle 胶囊。三种片剂都要整片吞服，不得压碎或咀嚼。老人出现明显嗜睡、进食饮水减少、步态或意识变化时，需要结合完整药单、肝功能、血细胞、血氨和血药浓度等由专业人员评估，不能自行停药或减半。", "history": "FDA Orange Book 记录 DEPAKOTE 250/500 mg 延迟释放片于 1983-03-10 获批，125 mg 于 1984-10-26 获批。DailyMed 当前标签于 2026-03-31 更新，展示三个准确 100 片瓶装面板，并保留肝毒性、胎儿风险和胰腺炎黑框警告。页面把准确产品、剂型、包装、历史和安全边界分开。", "sourceDocuments": [ { "id": "src_2b4dba40298b6fdc", "label": "DailyMed（NLM）：DEPAKOTE 双丙戊酸钠延迟释放片当前美国 NDA 品牌标签（2026-03-31 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=08a65cf4-7749-4ceb-6895-8f4805e2b01f", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, { "id": "src_10f9fa31428b78fd", "label": "FDA Drugs@FDA：DEPAKOTE NDA 018723 当前申请、RLD 与 RS 记录", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=018723", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_database_record", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, { "id": "src_190da96627768ce2", "label": "DailyMed（NLM）：DEPAKOTE ER 双丙戊酸钠缓释片当前美国标签（用于严格区分剂型）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=3a7ec88a-3379-4376-b49a-f60ae8b09fd0", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, { "id": "src_fe82ece6945b8032", "label": "DailyMed（NLM）：DEPAKOTE Sprinkle 双丙戊酸钠延迟释放胶囊当前美国标签（用于严格区分剂型）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=4619aff4-0f80-444f-858d-42e4137aa809", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } ], "applicationNumber": "FDA NDA 018723（DEPAKOTE divalproex sodium delayed-release tablets）", "approvalTimeline": [ { "date": "1983-03-10", "title": { "zh": "FDA 批准 DEPAKOTE 250/500 mg", "en": "FDA approved DEPAKOTE 250/500 mg" }, "detail": { "zh": "当前 Orange Book 将两个规格列为 RLD，并将 500 mg 列为 RS。", "en": "The current Orange Book lists both strengths as RLD products and 500 mg as the RS." }, "source": { "id": "src_10f9fa31428b78fd", "label": "FDA Drugs@FDA：DEPAKOTE NDA 018723 当前申请、RLD 与 RS 记录", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=018723", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_database_record", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } }, { "date": "1984-10-26", "title": { "zh": "FDA 批准 DEPAKOTE 125 mg", "en": "FDA approved DEPAKOTE 125 mg" }, "detail": { "zh": "当前 Orange Book 将 125 mg 延迟释放片列为 RLD。", "en": "The current Orange Book lists the 125 mg delayed-release tablet as an RLD." }, "source": { "id": "src_10f9fa31428b78fd", "label": "FDA Drugs@FDA：DEPAKOTE NDA 018723 当前申请、RLD 与 RS 记录", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=018723", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_database_record", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } }, { "date": "2026-03-31", "title": { "zh": "DailyMed 当前标签更新", "en": "Current DailyMed label updated" }, "detail": { "zh": "当前记录展示三个准确瓶装面板、Medication Guide、黑框警告、整片吞服与老年嗜睡等边界。", "en": "The current record displays three exact bottle panels, the Medication Guide, boxed warnings, whole-tablet handling and older-adult somnolence boundaries." }, "source": { "id": "src_2b4dba40298b6fdc", "label": "DailyMed（NLM）：DEPAKOTE 双丙戊酸钠延迟释放片当前美国 NDA 品牌标签（2026-03-31 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=08a65cf4-7749-4ceb-6895-8f4805e2b01f", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "当前处方 RLD 延迟释放片；500 mg 为 RS", "en": "Current prescription RLD delayed-release tablets; 500 mg is RS" }, "detail": { "zh": "三个 100 片瓶装面板已逐项建立。监管与包装记录不证明实时库存、购买资格、个人适用性或与其他丙戊酸制剂可替代。", "en": "Three 100-tablet bottle panels are recorded individually. Regulatory and package records do not establish real-time stock, purchasing eligibility, individual suitability or interchangeability with another valproate formulation." } }, { "market": { "zh": "中国大陆、欧盟、日本及其他市场", "en": "Mainland China, EU, Japan and other markets" }, "status": { "zh": "待逐项建立现行市场记录", "en": "Current market records not established" }, "detail": { "zh": "不从美国品牌名、相同成分或 mg 数字推定当地批准、剂型、供应、原研/仿制关系或可替代性。", "en": "No local approval, dosage form, supply, originator/generic relationship or interchangeability is inferred from a U.S. brand name, shared ingredient or mg figure." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "500 mg 的 DEPAKOTE 和 500 mg 的 DEPAKOTE ER 是一回事吗？", "en": "Are DEPAKOTE 500 mg and DEPAKOTE ER 500 mg the same?" }, "answer": { "zh": "不是同一剂型。本页是延迟释放片，ER 是另一种缓释片；相同 mg 只说明标签强度相同，不能证明释放曲线、使用频次或替换方式相同。不要自行一比一换药。", "en": "They are not the same dosage form. This page covers delayed-release tablets; ER is a different extended-release tablet. A shared mg strength does not establish the same release profile, frequency or switching method. Do not make a one-for-one switch yourself." } }, { "question": { "zh": "药片太大，可以掰一半或碾碎吗？", "en": "The tablet is large. Can it be halved or crushed?" }, "answer": { "zh": "本页三个 DEPAKOTE 延迟释放片均无刻痕，当前标签要求整片吞服，不得压碎或咀嚼。吞咽困难应让药师或开方团队核对准确处方与其他合适剂型，不能自行改成 Sprinkle 或 ER。", "en": "All three DEPAKOTE delayed-release tablets on this page are unscored, and the current label says to swallow whole and not crush or chew. A swallowing difficulty requires review of the exact prescription and a suitable formulation by a pharmacist or prescriber, not a self-switch to Sprinkle or ER." } }, { "question": { "zh": "为什么不是人人都做全基因筛查？", "en": "Why is whole-genome screening not routine for everyone?" }, "answer": { "zh": "标签关注的是特定高风险线索，例如已知 POLG 相关线粒体病和提示尿素循环障碍的病史；这不等于所有使用者都需要全基因筛查。检测范围应由专业团队依据年龄、病史、用途和症状决定。", "en": "The label focuses on specific high-risk clues such as known POLG-related mitochondrial disease and histories suggestive of a urea-cycle disorder. That does not mean every user needs whole-genome screening. The clinical team determines testing from age, history, indication and symptoms." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "dose-units-and-concentrations", "polypharmacy-safety-guide" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/depakote/", "en": "https://origindrug.com/en/drugs/depakote/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "nitrostat", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-29", "status": "published_traceable_archive" }, "names": { "brand": "NITROSTAT", "generic": "硝酸甘油舌下片", "aliases": [ "Nitrostat", "nitroglycerin sublingual tablets", "硝酸甘油舌下片", "硝酸甘油片", "nitroglycerin", "nitroglycerin sublingual", "glyceryl trinitrate", "硝酸甘油", "NDA 021134", "58151-309-01", "58151-310-01", "58151-311-01", "NITROSTAT 0.3 mg", "NITROSTAT 0.4 mg", "NITROSTAT 0.6 mg" ], "marketBrandNames": [ { "name": "NITROSTAT", "market": { "zh": "美国", "en": "United States" }, "evidenceStatus": "current_regulatory_record", "note": { "zh": "NDA 021134；0.3/0.4/0.6 mg 均为处方 RLD，0.6 mg 同时为 RS；三个现行 100 片包装面板已分开记录。", "en": "NDA 021134; 0.3/0.4/0.6 mg are prescription RLD products and 0.6 mg is also the RS; three current 100-tablet package panels are recorded separately." }, "source": { "id": "src_7f100d738fb4648f", "label": "FDA Drugs@FDA：NITROSTAT NDA 021134 当前申请、RLD 与 RS 记录", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=021134", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_database_record", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } } ], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "心血管", "sourceArchiveMarket": "美国：DailyMed 的 Viatris NDA 品牌标签列出 NITROSTAT 0.3、0.4、0.6 mg 舌下片及三个准确 100 片原装玻璃瓶/纸盒面板。FDA Orange Book 将三个规格列为处方 RLD，并将 0.6 mg 列为 RS。标签与 RLD 记录不证明实时库存、个人适用性、个人使用次数，也不证明与贴片、喷雾、软膏、静脉制剂或其他硝酸酯可互换。", "dosageFormClass": "硝酸甘油舌下片：每片 0.3、0.4 或 0.6 mg；放在舌下或颊囊让其溶解，不可像常规片剂那样直接咽下；应保留在原装玻璃瓶并每次用后立即拧紧", "dosageFormClassCode": "other", "route": "舌下或颊囊含化（高风险急症产品身份字段；不是胃肠道给药）", "routeCode": "other", "historicalApprovalEntry": "1981（当前标签所列美国初始批准）／2000-05-01（NDA 021134 重新配方批准）", "archiveSponsorText": "Viatris Specialty LLC（FDA Orange Book 当前申请主体；DailyMed 品牌标签分销方）" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [ "nitroglycerin extended-release capsules", "nitroglycerin transdermal patch", "nitroglycerin ointment", "nitroglycerin lingual spray", "nitroglycerin intravenous injection", "isosorbide mononitrate", "isosorbide dinitrate" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-nitrostat-nitroglycerin-sublingual-0-3mg-100-tablet-bottle-ndc-5815130901", "marketCode": "US", "labelVersion": { "zh": "DailyMed 美国 Viatris NDA 品牌标签（2023-02-15 更新；包装面板 2024 发布）", "en": "U.S. DailyMed Viatris NDA brand label (updated 15 Feb 2023; package panel published in 2024)" }, "dosageForm": { "zh": "NITROSTAT 硝酸甘油舌下片", "en": "NITROSTAT nitroglycerin sublingual tablet" }, "route": { "zh": "舌下或颊囊含化（不是普通吞服片）", "en": "sublingual or buccal dissolution (not a conventional swallowed tablet)" }, "routeCodes": [ "sublingual", "buccal" ], "productCode": "NDC 58151-309-01", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片硝酸甘油 0.3 mg；100 片原装玻璃瓶/纸盒", "en": "Nitroglycerin 0.3 mg per tablet; original 100-tablet glass bottle/carton" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=image-01.jpg&setid=9a52da75-d0af-4237-96c0-0b12adfa8636", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "硝酸甘油", "en": "nitroglycerin" }, "value": 0.3, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签强度；不是个人片数、频率、急救次数或疗程", "en": "label strength per tablet; not an individual's tablet count, frequency, emergency-use count or course" } } ], "concentration": null, "container": { "typeCode": "original_glass_bottle_carton", "typeLabel": { "zh": "100 片原装玻璃瓶及外盒", "en": "original 100-tablet glass bottle and carton" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-29", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "白色；纸盒紫色强度条", "en": "white; purple strength band on carton" }, "shape": { "zh": "白色、圆形、平面舌下片", "en": "white, round, flat-faced sublingual tablet" }, "imprint": "N / 3", "scoreStatus": "not_a_splitting_instruction", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_d77bd88670b086ba", "label": "DailyMed（NLM）：NITROSTAT 硝酸甘油舌下片美国 Viatris NDA 品牌标签（2023-02-15 更新；包装记录 2024 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=9a52da75-d0af-4237-96c0-0b12adfa8636", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-nitrostat-nitroglycerin-sublingual-0-4mg-100-tablet-bottle-ndc-5815131001", "marketCode": "US", "labelVersion": { "zh": "DailyMed 美国 Viatris NDA 品牌标签（2023-02-15 更新；包装面板 2024 发布）", "en": "U.S. DailyMed Viatris NDA brand label (updated 15 Feb 2023; package panel published in 2024)" }, "dosageForm": { "zh": "NITROSTAT 硝酸甘油舌下片", "en": "NITROSTAT nitroglycerin sublingual tablet" }, "route": { "zh": "舌下或颊囊含化（不是普通吞服片）", "en": "sublingual or buccal dissolution (not a conventional swallowed tablet)" }, "routeCodes": [ "sublingual", "buccal" ], "productCode": "NDC 58151-310-01", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片硝酸甘油 0.4 mg；100 片原装玻璃瓶/纸盒", "en": "Nitroglycerin 0.4 mg per tablet; original 100-tablet glass bottle/carton" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=image-02.jpg&setid=9a52da75-d0af-4237-96c0-0b12adfa8636", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "硝酸甘油", "en": "nitroglycerin" }, "value": 0.4, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签强度；不是个人片数、频率、急救次数或疗程", "en": "label strength per tablet; not an individual's tablet count, frequency, emergency-use count or course" } } ], "concentration": null, "container": { "typeCode": "original_glass_bottle_carton", "typeLabel": { "zh": "100 片原装玻璃瓶及外盒", "en": "original 100-tablet glass bottle and carton" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-29", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "白色；纸盒青绿色强度条", "en": "white; teal strength band on carton" }, "shape": { "zh": "白色、圆形、平面舌下片", "en": "white, round, flat-faced sublingual tablet" }, "imprint": "N / 4", "scoreStatus": "not_a_splitting_instruction", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_d77bd88670b086ba", "label": "DailyMed（NLM）：NITROSTAT 硝酸甘油舌下片美国 Viatris NDA 品牌标签（2023-02-15 更新；包装记录 2024 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=9a52da75-d0af-4237-96c0-0b12adfa8636", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-nitrostat-nitroglycerin-sublingual-0-6mg-100-tablet-bottle-ndc-5815131101", "marketCode": "US", "labelVersion": { "zh": "DailyMed 美国 Viatris NDA 品牌标签（2023-02-15 更新；包装面板 2024 发布）", "en": "U.S. DailyMed Viatris NDA brand label (updated 15 Feb 2023; package panel published in 2024)" }, "dosageForm": { "zh": "NITROSTAT 硝酸甘油舌下片", "en": "NITROSTAT nitroglycerin sublingual tablet" }, "route": { "zh": "舌下或颊囊含化（不是普通吞服片）", "en": "sublingual or buccal dissolution (not a conventional swallowed tablet)" }, "routeCodes": [ "sublingual", "buccal" ], "productCode": "NDC 58151-311-01", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片硝酸甘油 0.6 mg；100 片原装玻璃瓶/纸盒", "en": "Nitroglycerin 0.6 mg per tablet; original 100-tablet glass bottle/carton" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=image-03.jpg&setid=9a52da75-d0af-4237-96c0-0b12adfa8636", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "硝酸甘油", "en": "nitroglycerin" }, "value": 0.6, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签强度；不是个人片数、频率、急救次数或疗程", "en": "label strength per tablet; not an individual's tablet count, frequency, emergency-use count or course" } } ], "concentration": null, "container": { "typeCode": "original_glass_bottle_carton", "typeLabel": { "zh": "100 片原装玻璃瓶及外盒", "en": "original 100-tablet glass bottle and carton" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-29", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "白色；纸盒红色强度条", "en": "white; red strength band on carton" }, "shape": { "zh": "白色、圆形、平面舌下片", "en": "white, round, flat-faced sublingual tablet" }, "imprint": "N / 6", "scoreStatus": "not_a_splitting_instruction", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_d77bd88670b086ba", "label": "DailyMed（NLM）：NITROSTAT 硝酸甘油舌下片美国 Viatris NDA 品牌标签（2023-02-15 更新；包装记录 2024 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=9a52da75-d0af-4237-96c0-0b12adfa8636", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-nitrostat-nitroglycerin-sublingual-0-4mg-100-tablet-bottle-ndc-5815131001", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=image-02.jpg&setid=9a52da75-d0af-4237-96c0-0b12adfa8636", "alt": "NITROSTAT 0.4 mg、100 片、NDC 58151-310-01 的美国 DailyMed 当前包装标签展示面", "archiveMarket": "美国", "labelVersion": "DailyMed Viatris 品牌标签；2023-02 更新，包装面板 2024 发布", "presentation": "NITROSTAT 硝酸甘油舌下片，每片 0.4 mg，100 片原装玻璃瓶/纸盒，NDC 58151-310-01。", "notice": "此图只对应所引美国标签中的 0.4 mg、100 片原装玻璃瓶/纸盒；不代表 0.3/0.6 mg、25 片瓶、贴片、喷雾、软膏、静脉制剂、其他市场或实时库存。它不用于鉴定真伪，也不生成个人片数或急救方案。", "source": { "id": "src_d77bd88670b086ba", "label": "DailyMed（NLM）：NITROSTAT 硝酸甘油舌下片美国 Viatris NDA 品牌标签（2023-02-15 更新；包装记录 2024 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=9a52da75-d0af-4237-96c0-0b12adfa8636", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "NITROSTAT 说明书放大阅读：这是一款舌下片，不是普通吞服片", "en": "NITROSTAT label reading: this is a sublingual tablet, not a conventional swallowed tablet" }, "summary": { "zh": "0.3、0.4 和 0.6 mg 都是每片强度。标签要求将片剂置于舌下或颊囊让其溶解，不得压碎、咀嚼或吞下；三种规格还必须保留在原装玻璃瓶内并每次使用后立即拧紧，避免效价降低。网页只帮助读懂准确产品，不替任何人制定胸痛应急次数。", "en": "The 0.3, 0.4 and 0.6 mg figures are strengths per tablet. The label says to place a tablet under the tongue or in the buccal pouch and allow it to dissolve; do not crush, chew or swallow it. All three strengths must remain in the original glass container and be tightly capped immediately after each use to prevent loss of potency. This page identifies the product and does not create anyone's chest-pain action count." }, "checks": [ { "zh": "先看给药途径：NITROSTAT 是舌下/颊囊含化片。吞下、压碎或咀嚼会偏离标签；也不能因为药片很小就把 0.3、0.4、0.6 mg 相加或自行决定片数。", "en": "Check the route first: NITROSTAT dissolves under the tongue or in the buccal pouch. Swallowing, crushing or chewing departs from the label. A small tablet does not permit adding 0.3, 0.4 and 0.6 mg figures or choosing a tablet count yourself." }, { "zh": "新发、与平时不同、剧烈或持续胸痛可能是急症。应立即按个人既定应急计划和当地急救系统求助；不要等待网页、网上咨询或自行更换规格来判断。", "en": "New, different, severe or persistent chest pain may be an emergency. Follow the established emergency plan and contact local emergency services immediately; do not wait for a website, online advice or a self-chosen strength change." }, { "zh": "标签将 PDE-5 抑制剂（如西地那非、他达拉非、伐地那非、阿伐那非）和可溶性鸟苷酸环化酶刺激剂列为禁忌联用，因为可能造成严重低血压。即使药物不是同一天服用，也应让医生或药师按具体产品与时间核对，不能靠网页自行估算间隔。", "en": "The label contraindicates PDE-5 inhibitors such as sildenafil, tadalafil, vardenafil and avanafil, and soluble guanylate cyclase stimulators, because severe hypotension may occur. Even when products were not taken on the same day, a clinician or pharmacist must review the exact product and timing; this site does not calculate a safe interval." }, { "zh": "老人、低血压、脱水或正在使用降压药、利尿药、酒精及其他血管扩张药的人，头晕、乏力、晕厥和跌倒风险尤其需要核对。出现晕厥、意识改变或严重虚弱应及时求助。", "en": "Older adults and people with low blood pressure, dehydration, antihypertensives, diuretics, alcohol or other vasodilators need particular review for dizziness, weakness, syncope and falls. Fainting, altered awareness or severe weakness requires prompt help." }, { "zh": "口腔没有灼热或刺麻感并不能证明药物没有释放；有头痛也不能证明产品真假或自行追加。判断应依据准确包装、效期、原瓶储存、处方和专业评估。", "en": "No burning or tingling in the mouth does not prove failure of release, and a headache does not prove authenticity or justify self-adding a tablet. Use the exact pack, expiry, original-container storage, prescription and professional assessment." }, { "zh": "每次使用后立即拧紧原装玻璃瓶；不要转入药盒、塑料袋或与其他药混装。外出携带、过期或瓶盖未紧时，向药师核对更换与储存，不要凭外观或刺麻感判断效价。", "en": "Tightly recap the original glass bottle immediately after each use. Do not transfer tablets to a pill organiser, plastic bag or a mixed container. Ask a pharmacist about travel storage, expiry or a bottle left open; appearance or tingling cannot establish potency." } ], "source": { "id": "src_d77bd88670b086ba", "label": "DailyMed（NLM）：NITROSTAT 硝酸甘油舌下片美国 Viatris NDA 品牌标签（2023-02-15 更新；包装记录 2024 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=9a52da75-d0af-4237-96c0-0b12adfa8636", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "硝酸甘油怎样起作用：释放一氧化氮相关信号，使血管平滑肌松弛", "en": "How nitroglycerin works: nitric-oxide-related signalling relaxes vascular smooth muscle" }, "summary": { "zh": "硝酸甘油在体内形成一氧化氮相关信号，激活鸟苷酸环化酶并增加环磷酸鸟苷，使血管平滑肌松弛。静脉扩张可减少回心血量和心脏负荷，动脉扩张也可降低阻力。这个机理解释了为什么会出现头痛、头晕和低血压，也解释了为何不能与增强同一通路的 PDE-5 抑制剂或 sGC 刺激剂同用；它不能用来推算个人片数。", "en": "Nitroglycerin generates nitric-oxide-related signalling, activates guanylate cyclase and increases cyclic GMP, relaxing vascular smooth muscle. Venodilation can reduce venous return and cardiac workload, while arterial dilation can reduce resistance. This explains headache, dizziness and hypotension and why PDE-5 inhibitors or sGC stimulators that amplify the pathway are contraindicated. It cannot be used to calculate an individual's tablet count." }, "checks": [ { "zh": "‘舌下’说明给药途径和起效设计，不表示药量更大；口服吞下、贴片、喷雾、软膏和静脉制剂具有不同产品边界，不能按共同成分或 mg 数自行替换。", "en": "‘Sublingual’ describes the route and onset design, not a larger amount. Swallowed, patch, spray, ointment and intravenous products have different product boundaries and cannot be self-substituted from a shared ingredient or milligrams." }, { "zh": "血压下降、脱水、酒精或其他扩血管/降压药可能叠加影响；网页不根据某个血压数字判断是否继续、追加或停用。", "en": "Blood-pressure reduction, dehydration, alcohol and other vasodilating or antihypertensive medicines may have additive effects. This site does not use one blood-pressure reading to decide continuation, addition or stopping." }, { "zh": "此类作用不需要常规全基因筛查来决定每个人是否使用；是否需要检查由临床情况、药物清单、血压和相关疾病决定。", "en": "This mechanism does not create a routine whole-genome-screening requirement for everyone. Testing decisions depend on the clinical situation, medicine list, blood pressure and relevant conditions." } ], "source": { "id": "src_d77bd88670b086ba", "label": "DailyMed（NLM）：NITROSTAT 硝酸甘油舌下片美国 Viatris NDA 品牌标签（2023-02-15 更新；包装记录 2024 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=9a52da75-d0af-4237-96c0-0b12adfa8636", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "NITROSTAT", "generic": "硝酸甘油舌下片", "dosageFormClass": "硝酸甘油舌下片：每片 0.3、0.4 或 0.6 mg；放在舌下或颊囊让其溶解，不可像常规片剂那样直接咽下；应保留在原装玻璃瓶并每次用后立即拧紧" }, "labelSource": { "id": "src_d77bd88670b086ba", "label": "DailyMed（NLM）：NITROSTAT 硝酸甘油舌下片美国 Viatris NDA 品牌标签（2023-02-15 更新；包装记录 2024 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=9a52da75-d0af-4237-96c0-0b12adfa8636", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "productRoutes": [ { "source": { "id": "src_d77bd88670b086ba", "label": "DailyMed（NLM）：NITROSTAT 硝酸甘油舌下片美国 Viatris NDA 品牌标签（2023-02-15 更新；包装记录 2024 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=9a52da75-d0af-4237-96c0-0b12adfa8636", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-29", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_7f100d738fb4648f", "label": "FDA Drugs@FDA：NITROSTAT NDA 021134 当前申请、RLD 与 RS 记录", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=021134", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_database_record", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-08-29", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-29", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "NITROSTAT 是硝酸甘油舌下片，不是像普通药片一样吞下。药盒上的 0.3、0.4 或 0.6 mg 指每片强度，不是一次该用几片。它必须和胸痛应急计划、完整药单以及西地那非、他达拉非、伐地那非、阿伐那非或可溶性鸟苷酸环化酶刺激剂等禁忌联用信息一起核对。新发、异常、剧烈或持续胸痛应立即按当地急救路径求助，不要依赖网页判断或等待。", "history": "硝酸甘油舌下制剂在美国有长期使用历史。当前标签标示美国初始批准为 1981；FDA 于 2000-05-01 批准 NDA 021134 的 0.3、0.4、0.6 mg 压制舌下片重新配方，审评资料说明该调整旨在改善重量控制、含量均匀度和物理稳定性。当前 DailyMed 品牌标签于 2023-02 更新，并在 2024 年发布现行三个 100 片包装面板。", "sourceDocuments": [ { "id": "src_d77bd88670b086ba", "label": "DailyMed（NLM）：NITROSTAT 硝酸甘油舌下片美国 Viatris NDA 品牌标签（2023-02-15 更新；包装记录 2024 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=9a52da75-d0af-4237-96c0-0b12adfa8636", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, { "id": "src_7f100d738fb4648f", "label": "FDA Drugs@FDA：NITROSTAT NDA 021134 当前申请、RLD 与 RS 记录", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=021134", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_database_record", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, { "id": "src_1c7f2919c4ac2cdd", "label": "FDA：NITROSTAT NDA 021134 重新配方舌下片批准信（2000-05-01）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21134_Nitrostat_Approv.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "regulatory_approval_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_pdf", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } ], "applicationNumber": "FDA NDA 021134（NITROSTAT nitroglycerin sublingual tablets）", "approvalTimeline": [ { "date": "1981", "title": { "zh": "当前标签所列美国初始批准", "en": "Initial U.S. approval stated in the current label" }, "detail": { "zh": "这是当前标签的历史字段；不等同于 NDA 021134 重新配方批准日期。", "en": "This is the historical field in the current label; it is not the NDA 021134 reformulation approval date." }, "source": { "id": "src_d77bd88670b086ba", "label": "DailyMed（NLM）：NITROSTAT 硝酸甘油舌下片美国 Viatris NDA 品牌标签（2023-02-15 更新；包装记录 2024 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=9a52da75-d0af-4237-96c0-0b12adfa8636", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } }, { "date": "2000-05-01", "title": { "zh": "FDA 批准 NDA 021134 重新配方", "en": "FDA approved the NDA 021134 reformulation" }, "detail": { "zh": "批准信涵盖 0.3、0.4、0.6 mg 舌下片；审评资料记录改进重量控制、含量均匀度与物理稳定性的目的。", "en": "The approval covers 0.3, 0.4 and 0.6 mg sublingual tablets; review records describe improvements in weight control, content uniformity and physical stability." }, "source": { "id": "src_1c7f2919c4ac2cdd", "label": "FDA：NITROSTAT NDA 021134 重新配方舌下片批准信（2000-05-01）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21134_Nitrostat_Approv.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "regulatory_approval_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_pdf", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } }, { "date": "2023-02 / 2024", "title": { "zh": "当前标签修订与包装发布", "en": "Current label revision and package publication" }, "detail": { "zh": "DailyMed 标签修订于 2023-02，三个 Viatris 100 片包装记录于 2024 发布。", "en": "The DailyMed label was revised in Feb 2023, and three Viatris 100-tablet package records were published in 2024." }, "source": { "id": "src_d77bd88670b086ba", "label": "DailyMed（NLM）：NITROSTAT 硝酸甘油舌下片美国 Viatris NDA 品牌标签（2023-02-15 更新；包装记录 2024 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=9a52da75-d0af-4237-96c0-0b12adfa8636", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "当前处方 RLD 舌下片；0.6 mg 为 RS", "en": "Current prescription RLD sublingual tablets; 0.6 mg is RS" }, "detail": { "zh": "三个 100 片原装玻璃瓶/纸盒面板已逐项建立。监管与包装记录不证明实时库存、购买资格或个人应急安排。", "en": "Three original 100-tablet glass-bottle/carton panels are recorded individually. Regulatory and package records do not establish real-time stock, purchasing eligibility or an individual's emergency plan." } }, { "market": { "zh": "中国大陆、欧盟、日本及其他市场", "en": "Mainland China, EU, Japan and other markets" }, "status": { "zh": "待逐项建立现行市场记录", "en": "Current market records not established" }, "detail": { "zh": "不从美国品牌名、共同成分或 mg 数推定当地批准、包装、供应或可替代性。", "en": "No local approval, package, supply or interchangeability is inferred from a U.S. brand, shared ingredient or mg figure." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "硝酸甘油片是吞下去还是含在舌下？", "en": "Is a NITROSTAT tablet swallowed or placed under the tongue?" }, "answer": { "zh": "本档案的 NITROSTAT 是舌下片：标签要求放在舌下或颊囊让其溶解，不得压碎、咀嚼或吞下。其他硝酸甘油剂型不能套用这条说明。", "en": "This NITROSTAT dossier covers a sublingual tablet. The label says to place it under the tongue or in the buccal pouch and let it dissolve; do not crush, chew or swallow it. Do not transfer this instruction to another nitroglycerin form." } }, { "question": { "zh": "药片可以分装到一周药盒吗？", "en": "Can the tablets be moved into a weekly pill organiser?" }, "answer": { "zh": "标签要求保留在原装玻璃瓶并每次使用后立即拧紧，以防效价降低。不要与日常药混装；携带和更换问题请让药师按实际瓶子核对。", "en": "The label says to keep the tablets in the original glass container and tightly cap it immediately after use to prevent loss of potency. Do not mix them with routine medicines; ask a pharmacist about carrying and replacement using the actual bottle." } }, { "question": { "zh": "用了西地那非或他达拉非，还能含硝酸甘油吗？", "en": "Can NITROSTAT be used after sildenafil or tadalafil?" }, "answer": { "zh": "现行标签把 PDE-5 抑制剂与 NITROSTAT 列为禁忌联用，因为可能出现严重低血压。不要自行估算安全间隔；胸痛时立即联系急救并告知所用产品、剂量和时间。", "en": "Current labelling contraindicates PDE-5 inhibitors with NITROSTAT because severe hypotension may occur. Do not calculate a safe interval yourself. During chest pain, contact emergency services and report the exact product, amount and time taken." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "dose-units-and-concentrations", "polypharmacy-safety-guide" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/nitrostat/", "en": "https://origindrug.com/en/drugs/nitrostat/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "ranexa", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-30", "status": "published_traceable_archive" }, "names": { "brand": "RANEXA", "generic": "雷诺嗪缓释片", "aliases": [ "Ranexa", "ranolazine", "ranolazine prolonged-release tablets", "ranolazine extended-release tablets", "雷诺嗪", "雷诺嗪缓释片", "Latixa", "RANEXA", "NDA 021526", "EMEA/H/C/000805", "61958-1001-1", "61958-1002-1", "RANEXA 375 mg", "RANEXA 500 mg", "RANEXA 750 mg", "RANEXA 1000 mg" ], "marketBrandNames": [ { "name": "RANEXA", "market": { "zh": "欧盟", "en": "European Union" }, "evidenceStatus": "current_regulatory_record", "note": { "zh": "EMEA/H/C/000805 当前集中许可；375、500、750 mg 缓释片。", "en": "Current central authorisation EMEA/H/C/000805; 375, 500 and 750 mg prolonged-release tablets." }, "source": { "id": "src_dda7652ff2b4daab", "label": "EMA：RANEXA（ranolazine）欧盟集中许可 EPAR、公众概要与药物警戒入口", "url": "https://www.ema.europa.eu/en/medicines/human/EPAR/ranexa", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" } }, { "name": "RANEXA", "market": { "zh": "美国", "en": "United States" }, "evidenceStatus": "historical_regulatory_record", "note": { "zh": "NDA 021526 的 500 与 1000 mg 历史 RLD 当前均列为 Discontinued；旧包装图只用于识别历史标签。", "en": "Historical RLD products under NDA 021526 at 500 and 1000 mg are currently listed as Discontinued; old pack images identify only the dated label." }, "source": { "id": "src_da847698c2fd996c", "label": "FDA Drugs@FDA：RANEXA NDA 021526 申请、历史 RLD 与停止销售状态", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=021526", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_database_record", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" } } ], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "心血管", "sourceArchiveMarket": "欧盟：EMA 当前集中许可 RANEXA 375、500、750 mg 缓释片，持有人为 Menarini International Operations Luxembourg S.A.。美国：FDA NDA 021526 的 500 与 1000 mg 历史 RLD 当前均列为 Discontinued；2010 DailyMed 品牌标签的两个 60 片瓶装面板只作为有日期历史包装。欧盟和美国的强度、标签、外观及状态不能合并成换算表，监管记录不证明实时库存或个人适用性。", "dosageFormClass": "雷诺嗪缓释片：欧盟当前 375/500/750 mg；美国历史 500/1000 mg。片剂应整片吞服，不得压碎、掰开或咀嚼；不同市场毫克数不是自行换算或多片拼规格依据", "dosageFormClassCode": "oral_modified_release", "route": "口服（缓释片准确产品身份字段；整片吞服）", "routeCode": "oral", "historicalApprovalEntry": "2006-01-27（美国初始批准）；2008-07-09（欧盟集中许可）", "archiveSponsorText": "Menarini International Operations Luxembourg S.A.（EMA 当前持有人）；CV Therapeutics／Gilead Sciences（美国历史申请与标签主体）" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [ "NITROSTAT", "nitroglycerin", "硝酸甘油", "MONOKET", "isosorbide mononitrate", "IMDUR", "isosorbide dinitrate", "RANEXA oral suspension", "ranolazine immediate-release" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "eu-ranexa-ranolazine-prolonged-release-375mg-tablet-emea-h-c-000805", "marketCode": "EU", "labelVersion": { "zh": "EMA 当前欧盟产品资料（2026-08-30 核验）", "en": "Current EU EMA product information (verified 30 Aug 2026)" }, "dosageForm": { "zh": "RANEXA 雷诺嗪缓释片", "en": "RANEXA ranolazine prolonged-release tablet" }, "route": { "zh": "口服；整片吞服（产品身份字段）", "en": "oral; swallowed whole (product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "EMA EMEA/H/C/000805 · 375 mg", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片雷诺嗪 375 mg；欧盟缓释片", "en": "Ranolazine 375 mg per tablet; EU prolonged-release tablet" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "雷诺嗪", "en": "ranolazine" }, "value": 375, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片欧盟标签强度；不是个人片数、频率、增量或换药指令", "en": "EU labelled strength per tablet; not an individual's tablet count, frequency, titration or switching instruction" } } ], "concentration": null, "container": { "typeCode": "eu_pack_not_fixed_in_dossier", "typeLabel": { "zh": "欧盟产品资料列示多种包装；本卡不推定手中包装片数", "en": "EU product information lists multiple packs; this card does not infer the pack in hand" }, "fill": null, "countPerPackage": null, "countUnit": null }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-30", "currentLabelDisplayed": true, "ndcDirectoryListed": false, "marketAvailability": "active_central_authorisation", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": null, "physicalClues": { "color": { "zh": "浅蓝色", "en": "pale blue" }, "shape": { "zh": "椭圆形缓释片", "en": "oval prolonged-release tablet" }, "imprint": "375", "scoreStatus": "unscored_swallow_whole", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_44834e9ac9035e8e", "label": "EMA：RANEXA 雷诺嗪 375/500/750 mg 缓释片当前欧盟产品资料与患者说明书", "url": "https://www.ema.europa.eu/en/documents/product-information/ranexa-epar-product-information_en.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "EU", "accessStatus": "public_access_requires_interaction", "accessMode": "public_pdf", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "eu-ranexa-ranolazine-prolonged-release-500mg-tablet-emea-h-c-000805", "marketCode": "EU", "labelVersion": { "zh": "EMA 当前欧盟产品资料（2026-08-30 核验）", "en": "Current EU EMA product information (verified 30 Aug 2026)" }, "dosageForm": { "zh": "RANEXA 雷诺嗪缓释片", "en": "RANEXA ranolazine prolonged-release tablet" }, "route": { "zh": "口服；整片吞服（产品身份字段）", "en": "oral; swallowed whole (product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "EMA EMEA/H/C/000805 · 500 mg", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片雷诺嗪 500 mg；欧盟缓释片", "en": "Ranolazine 500 mg per tablet; EU prolonged-release tablet" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "雷诺嗪", "en": "ranolazine" }, "value": 500, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片欧盟标签强度；不是个人片数、频率、增量或换药指令", "en": "EU labelled strength per tablet; not an individual's tablet count, frequency, titration or switching instruction" } } ], "concentration": null, "container": { "typeCode": "eu_pack_not_fixed_in_dossier", "typeLabel": { "zh": "欧盟产品资料列示多种包装；本卡不推定手中包装片数", "en": "EU product information lists multiple packs; this card does not infer the pack in hand" }, "fill": null, "countPerPackage": null, "countUnit": null }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-30", "currentLabelDisplayed": true, "ndcDirectoryListed": false, "marketAvailability": "active_central_authorisation", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": null, "physicalClues": { "color": { "zh": "浅橙色", "en": "light orange" }, "shape": { "zh": "椭圆形缓释片", "en": "oval prolonged-release tablet" }, "imprint": "500", "scoreStatus": "unscored_swallow_whole", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_44834e9ac9035e8e", "label": "EMA：RANEXA 雷诺嗪 375/500/750 mg 缓释片当前欧盟产品资料与患者说明书", "url": "https://www.ema.europa.eu/en/documents/product-information/ranexa-epar-product-information_en.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "EU", "accessStatus": "public_access_requires_interaction", "accessMode": "public_pdf", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "eu-ranexa-ranolazine-prolonged-release-750mg-tablet-emea-h-c-000805", "marketCode": "EU", "labelVersion": { "zh": "EMA 当前欧盟产品资料（2026-08-30 核验）", "en": "Current EU EMA product information (verified 30 Aug 2026)" }, "dosageForm": { "zh": "RANEXA 雷诺嗪缓释片", "en": "RANEXA ranolazine prolonged-release tablet" }, "route": { "zh": "口服；整片吞服（产品身份字段）", "en": "oral; swallowed whole (product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "EMA EMEA/H/C/000805 · 750 mg", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片雷诺嗪 750 mg；欧盟缓释片", "en": "Ranolazine 750 mg per tablet; EU prolonged-release tablet" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "雷诺嗪", "en": "ranolazine" }, "value": 750, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片欧盟标签强度；不是个人片数、频率、增量或换药指令", "en": "EU labelled strength per tablet; not an individual's tablet count, frequency, titration or switching instruction" } } ], "concentration": null, "container": { "typeCode": "eu_pack_not_fixed_in_dossier", "typeLabel": { "zh": "欧盟产品资料列示多种包装；本卡不推定手中包装片数", "en": "EU product information lists multiple packs; this card does not infer the pack in hand" }, "fill": null, "countPerPackage": null, "countUnit": null }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-30", "currentLabelDisplayed": true, "ndcDirectoryListed": false, "marketAvailability": "active_central_authorisation", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": null, "physicalClues": { "color": { "zh": "浅绿色", "en": "pale green" }, "shape": { "zh": "椭圆形缓释片", "en": "oval prolonged-release tablet" }, "imprint": "750", "scoreStatus": "unscored_swallow_whole", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_44834e9ac9035e8e", "label": "EMA：RANEXA 雷诺嗪 375/500/750 mg 缓释片当前欧盟产品资料与患者说明书", "url": "https://www.ema.europa.eu/en/documents/product-information/ranexa-epar-product-information_en.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "EU", "accessStatus": "public_access_requires_interaction", "accessMode": "public_pdf", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-ranexa-ranolazine-extended-release-500mg-60-tablet-bottle-ndc-6195810011-historical", "marketCode": "US", "labelVersion": { "zh": "DailyMed 美国 Gilead 历史品牌标签（2010-04-26 更新；当前 Orange Book 列为 Discontinued）", "en": "U.S. DailyMed Gilead historical brand label (updated 26 Apr 2010; currently listed as Discontinued in the Orange Book)" }, "dosageForm": { "zh": "RANEXA 雷诺嗪薄膜衣缓释片", "en": "RANEXA ranolazine film-coated extended-release tablet" }, "route": { "zh": "口服；整片吞服（美国历史产品身份字段）", "en": "oral; swallowed whole (historical U.S. product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 61958-1001-1", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片雷诺嗪 500 mg；60 片瓶装（美国历史品牌标签）", "en": "Ranolazine 500 mg per tablet; 60-tablet bottle (historical U.S. brand label)" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=ranexa-02.jpg&setid=8d442b8c-97a8-40a9-8603-f9cd0542cedc&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "雷诺嗪", "en": "ranolazine" }, "value": 500, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片历史标签强度；不是个人片数、频率、增量或与欧盟规格的换算", "en": "historical labelled strength per tablet; not an individual's tablet count, frequency, titration or conversion to an EU strength" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 60, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-30", "currentLabelDisplayed": false, "ndcDirectoryListed": false, "marketAvailability": "historical_brand_record_discontinued", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 60, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "浅橙色", "en": "light orange" }, "shape": { "zh": "长椭圆形、无刻痕缓释片", "en": "oblong, unscored extended-release tablet" }, "imprint": "CVT500", "scoreStatus": "unscored_swallow_whole", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_dc736b24157dc510", "label": "DailyMed（NLM）：RANEXA 雷诺嗪 500/1000 mg 缓释片美国 Gilead 历史品牌标签（2010-04-26 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8d442b8c-97a8-40a9-8603-f9cd0542cedc", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-ranexa-ranolazine-extended-release-1000mg-60-tablet-bottle-ndc-6195810021-historical", "marketCode": "US", "labelVersion": { "zh": "DailyMed 美国 Gilead 历史品牌标签（2010-04-26 更新；当前 Orange Book 列为 Discontinued）", "en": "U.S. DailyMed Gilead historical brand label (updated 26 Apr 2010; currently listed as Discontinued in the Orange Book)" }, "dosageForm": { "zh": "RANEXA 雷诺嗪薄膜衣缓释片", "en": "RANEXA ranolazine film-coated extended-release tablet" }, "route": { "zh": "口服；整片吞服（美国历史产品身份字段）", "en": "oral; swallowed whole (historical U.S. product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 61958-1002-1", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片雷诺嗪 1000 mg；60 片瓶装（美国历史品牌标签）", "en": "Ranolazine 1000 mg per tablet; 60-tablet bottle (historical U.S. brand label)" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=ranexa-03.jpg&setid=8d442b8c-97a8-40a9-8603-f9cd0542cedc&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "雷诺嗪", "en": "ranolazine" }, "value": 1000, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片历史标签强度；不是个人片数、频率、增量或与欧盟规格的换算", "en": "historical labelled strength per tablet; not an individual's tablet count, frequency, titration or conversion to an EU strength" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 60, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-30", "currentLabelDisplayed": false, "ndcDirectoryListed": false, "marketAvailability": "historical_brand_record_discontinued", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 60, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "浅黄色", "en": "pale yellow" }, "shape": { "zh": "长椭圆形、无刻痕缓释片", "en": "oblong, unscored extended-release tablet" }, "imprint": "CVT1000", "scoreStatus": "unscored_swallow_whole", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_dc736b24157dc510", "label": "DailyMed（NLM）：RANEXA 雷诺嗪 500/1000 mg 缓释片美国 Gilead 历史品牌标签（2010-04-26 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8d442b8c-97a8-40a9-8603-f9cd0542cedc", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-ranexa-ranolazine-extended-release-500mg-60-tablet-bottle-ndc-6195810011-historical", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=ranexa-02.jpg&setid=8d442b8c-97a8-40a9-8603-f9cd0542cedc&type=img", "alt": "RANEXA 雷诺嗪缓释片 500 mg、60 片、NDC 61958-1001-1 的美国 2010 DailyMed 历史标签展示面", "archiveMarket": "美国", "labelVersion": "DailyMed Gilead 历史品牌标签；2010-04-26 更新；当前产品行已停止销售", "presentation": "RANEXA 雷诺嗪缓释片，每片 500 mg，60 片瓶装，NDC 61958-1001-1（美国历史包装）。", "notice": "此图仅对应美国 2010 历史标签中的 500 mg、60 片瓶装；不代表美国当前供应，也不代表欧盟 375/500/750 mg 包装、1000 mg 历史瓶或其他市场产品。包装图只用于辅助核对，不用于鉴定真伪。", "source": { "id": "src_dc736b24157dc510", "label": "DailyMed（NLM）：RANEXA 雷诺嗪 500/1000 mg 缓释片美国 Gilead 历史品牌标签（2010-04-26 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8d442b8c-97a8-40a9-8603-f9cd0542cedc", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "RANEXA 说明书放大阅读：缓释片要整片吞服，也不是胸痛急救药", "en": "RANEXA label reading: swallow the prolonged-release tablet whole, and do not treat it as an acute-rescue medicine" }, "summary": { "zh": "欧盟当前资料与美国历史品牌标签均要求整片吞服，不得压碎、掰开或咀嚼。欧盟当前强度是 375、500、750 mg，美国历史强度是 500、1000 mg；这些数字不能跨市场换算。RANEXA 不会终止一次急性心绞痛发作，新发、异常、剧烈或持续胸痛应立即按既定急救计划和当地急救系统处理。", "en": "Current EU information and the historical U.S. brand label both say to swallow the tablet whole and not crush, break or chew it. Current EU strengths are 375, 500 and 750 mg, while historical U.S. strengths are 500 and 1000 mg; these figures are not a cross-market conversion table. RANEXA will not abate an acute angina episode. New, different, severe or persistent chest pain requires the established emergency plan and local emergency services." }, "checks": [ { "zh": "先看‘缓释’：不得压碎、掰开或咀嚼。片上没有刻痕不等于可以凭感觉掰半；即使某个市场出现相同 mg 数，也不能把多个小规格自行拼成另一个市场的大规格。", "en": "Start with ‘prolonged/extended release’: do not crush, break or chew. An unscored tablet is not permission to split by feel, and a shared mg figure across markets does not permit assembling one market's larger strength from another's smaller tablets." }, { "zh": "RANEXA 是长期稳定型心绞痛用药档案，不是 NITROSTAT 等舌下硝酸甘油的急救替代品。胸痛新发、与平时不同、剧烈、持续，或伴呼吸困难、出汗、晕厥等表现时，应立即使用当地急救服务，不要等待网页或自行追加。", "en": "RANEXA is a chronic stable-angina dossier, not a rescue substitute for sublingual nitroglycerin such as NITROSTAT. New, different, severe or persistent chest pain, or pain with breathing difficulty, sweating or fainting, requires immediate local emergency care; do not wait for a website or self-add a tablet." }, { "zh": "强 CYP3A 抑制剂（如克拉霉素、酮康唑、伊曲康唑、伏立康唑及部分 HIV 蛋白酶抑制剂）和诱导剂（如利福平、卡马西平、苯妥英、苯巴比妥、圣约翰草）是优先核对项；不要靠错开几小时自行解决。", "en": "Strong CYP3A inhibitors such as clarithromycin, ketoconazole, itraconazole, voriconazole and some HIV protease inhibitors, and inducers such as rifampin, carbamazepine, phenytoin, phenobarbital and St John's wort, are priority review items. Do not try to solve them by self-separating doses by a few hours." }, { "zh": "地尔硫䓬、维拉帕米、氟康唑、红霉素、环孢素和葡萄柚等可影响雷诺嗪暴露；地高辛、辛伐他汀、二甲双胍及其他药物也可能需要一起核对。网页不根据两个药名给出能否同服或怎样减量。", "en": "Diltiazem, verapamil, fluconazole, erythromycin, ciclosporin and grapefruit can affect ranolazine exposure; digoxin, simvastatin, metformin and other medicines may also need joint review. This site does not decide co-use or dose reduction from two names." }, { "zh": "雷诺嗪可延长 QT。本人或家族有长 QT、正在服用胺碘酮、索他洛尔、某些抗精神病药或其他延长 QT 药物，或出现晕厥、心悸、严重头晕时，应尽快让医疗团队核对；严重或持续症状需立即求助。", "en": "Ranolazine can prolong QT. A personal or family long-QT history, amiodarone, sotalol, certain antipsychotics or other QT-prolonging medicines, or fainting, palpitations or severe dizziness needs prompt clinical review; severe or persistent symptoms require immediate help." }, { "zh": "老人、体重不超过 60 kg、肾功能下降、肝功能问题或中重度心衰会增加暴露或不良反应核对的重要性。头晕、乏力、便秘、恶心和跌倒风险要结合完整药单与监测计划处理，不能自行停药或换药。", "en": "Older age, weight at or below 60 kg, reduced kidney function, liver problems or moderate-to-severe heart failure increases the importance of exposure and adverse-event review. Dizziness, weakness, constipation, nausea and fall risk must be handled with the full medicine list and monitoring plan, not self-stopping or switching." } ], "source": { "id": "src_44834e9ac9035e8e", "label": "EMA：RANEXA 雷诺嗪 375/500/750 mg 缓释片当前欧盟产品资料与患者说明书", "url": "https://www.ema.europa.eu/en/documents/product-information/ranexa-epar-product-information_en.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "EU", "accessStatus": "public_access_requires_interaction", "accessMode": "public_pdf", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "雷诺嗪怎样起作用：可能减少心肌细胞内钠、钙负荷，但机制不能变成个人选药规则", "en": "How ranolazine works: it may reduce myocardial sodium/calcium loading, but the mechanism is not a personal selection rule" }, "summary": { "zh": "美国标签说明雷诺嗪的抗心绞痛确切机制尚未完全确定，并记录其在治疗浓度可抑制心肌晚期钠电流；EMA 公众概要以减少进入心肌细胞的钙离子流来解释可能的舒张作用。这个机制只帮助理解稳定型心绞痛、QT、相互作用和监测，不能推算个人片数、急救方案或与硝酸甘油、β 受体阻滞剂、钙通道阻滞剂的替换。", "en": "The U.S. label says the precise antianginal mechanism is not fully determined and records inhibition of the cardiac late sodium current at therapeutic concentrations; the EMA public overview explains a possible relaxation effect through reduced calcium-ion entry into heart-muscle cells. This only supports understanding stable angina, QT, interactions and monitoring. It cannot calculate a tablet count, emergency plan or substitution with nitroglycerin, a beta blocker or a calcium-channel blocker." }, "checks": [ { "zh": "雷诺嗪对晚期钠电流和 QT 的作用不是‘越多越好’的证据；暴露受肝肾功能、体重和相互作用药物影响，不能从胸痛频率或心电图数字自行加量。", "en": "Effects on late sodium current and QT are not evidence that more is better. Exposure varies with liver/kidney function, body weight and interacting medicines, so chest-pain frequency or one ECG number cannot direct self-increase." }, { "zh": "EMA 资料提到已知 CYP2D6 代谢状态可在多重风险因素下帮助专业评估，但这不等于所有人都应做全基因筛查。网页不从基因结果替个人选择、加减或停用 RANEXA。", "en": "EMA information notes that known CYP2D6 metaboliser status may inform professional caution when several risk factors coexist, but this is not a recommendation for whole-genome screening in everyone. The site does not use a genetic result to select, increase, reduce or stop RANEXA for an individual." }, { "zh": "稳定型心绞痛的长期作用与急性胸痛处置是两件事；不要因为机理听起来‘改善供血’就把缓释片当急救药，或停掉既定的急救与长期方案。", "en": "Long-term stable-angina action and acute chest-pain response are different. A mechanism that sounds like ‘improving blood flow’ does not turn an extended-release tablet into a rescue medicine or justify stopping an established emergency or long-term plan." } ], "source": { "id": "src_dc736b24157dc510", "label": "DailyMed（NLM）：RANEXA 雷诺嗪 500/1000 mg 缓释片美国 Gilead 历史品牌标签（2010-04-26 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8d442b8c-97a8-40a9-8603-f9cd0542cedc", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "RANEXA", "generic": "雷诺嗪缓释片", "dosageFormClass": "雷诺嗪缓释片：欧盟当前 375/500/750 mg；美国历史 500/1000 mg。片剂应整片吞服，不得压碎、掰开或咀嚼；不同市场毫克数不是自行换算或多片拼规格依据" }, "labelSource": { "id": "src_44834e9ac9035e8e", "label": "EMA：RANEXA 雷诺嗪 375/500/750 mg 缓释片当前欧盟产品资料与患者说明书", "url": "https://www.ema.europa.eu/en/documents/product-information/ranexa-epar-product-information_en.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "EU", "accessStatus": "public_access_requires_interaction", "accessMode": "public_pdf", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "productRoutes": [ { "source": { "id": "src_44834e9ac9035e8e", "label": "EMA：RANEXA 雷诺嗪 375/500/750 mg 缓释片当前欧盟产品资料与患者说明书", "url": "https://www.ema.europa.eu/en/documents/product-information/ranexa-epar-product-information_en.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "EU", "accessStatus": "public_access_requires_interaction", "accessMode": "public_pdf", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "status": "product_level_public_record_verified", "authority": { "zh": "EMA", "en": "EMA" }, "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "recordType": { "zh": "监管产品记录或欧盟产品资料", "en": "Regulatory product record or EU product information" }, "reviewedAt": "2026-08-30", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_dda7652ff2b4daab", "label": "EMA：RANEXA（ranolazine）欧盟集中许可 EPAR、公众概要与药物警戒入口", "url": "https://www.ema.europa.eu/en/medicines/human/EPAR/ranexa", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "status": "product_level_public_record_verified", "authority": { "zh": "EMA", "en": "EMA" }, "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "recordType": { "zh": "监管产品记录或欧盟产品资料", "en": "Regulatory product record or EU product information" }, "reviewedAt": "2026-08-30", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_dc736b24157dc510", "label": "DailyMed（NLM）：RANEXA 雷诺嗪 500/1000 mg 缓释片美国 Gilead 历史品牌标签（2010-04-26 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8d442b8c-97a8-40a9-8603-f9cd0542cedc", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-30", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_da847698c2fd996c", "label": "FDA Drugs@FDA：RANEXA NDA 021526 申请、历史 RLD 与停止销售状态", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=021526", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_database_record", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-08-30", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "EMA", "en": "EMA" }, "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "recordType": { "zh": "监管产品记录或欧盟产品资料", "en": "Regulatory product record or EU product information" }, "reviewedAt": "2026-08-30", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "RANEXA 是雷诺嗪缓释片，用于稳定型心绞痛长期治疗场景，不是胸痛发作时替代硝酸甘油的急救药。‘缓释’表示药物随时间释放，因此必须整片吞服，不得压碎、掰开或咀嚼。老人、肾功能或肝功能问题、低体重、头晕跌倒风险，以及与克拉霉素、唑类抗真菌药、地尔硫䓬、维拉帕米、卡马西平、利福平、圣约翰草、葡萄柚、地高辛、辛伐他汀和其他延长 QT 药物同用时，都应带完整药单让医生或药师逐项核对。", "history": "FDA 于 2006-01-27 批准 NDA 021526 的 RANEXA 500 mg 缓释片，2007-02-12 批准 1000 mg；FDA 原始批准信保留了用于证明缓释特性的多时间点溶出要求。欧盟于 2008-07-09 授予 RANEXA 集中许可，当前产品资料列 375、500、750 mg 缓释片。美国两个历史 RLD 现均列为 Discontinued，因此美国旧包装图不能写成当前供应。", "sourceDocuments": [ { "id": "src_dda7652ff2b4daab", "label": "EMA：RANEXA（ranolazine）欧盟集中许可 EPAR、公众概要与药物警戒入口", "url": "https://www.ema.europa.eu/en/medicines/human/EPAR/ranexa", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, { "id": "src_44834e9ac9035e8e", "label": "EMA：RANEXA 雷诺嗪 375/500/750 mg 缓释片当前欧盟产品资料与患者说明书", "url": "https://www.ema.europa.eu/en/documents/product-information/ranexa-epar-product-information_en.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "EU", "accessStatus": "public_access_requires_interaction", "accessMode": "public_pdf", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, { "id": "src_dc736b24157dc510", "label": "DailyMed（NLM）：RANEXA 雷诺嗪 500/1000 mg 缓释片美国 Gilead 历史品牌标签（2010-04-26 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8d442b8c-97a8-40a9-8603-f9cd0542cedc", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, { "id": "src_da847698c2fd996c", "label": "FDA Drugs@FDA：RANEXA NDA 021526 申请、历史 RLD 与停止销售状态", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=021526", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_database_record", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, { "id": "src_bb114a794784e085", "label": "FDA：RANEXA NDA 021526 原始批准信（2006-01-27；缓释产品溶出要求）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021526_s000_Ranexa_Approv.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "regulatory_approval_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_pdf", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" } ], "applicationNumber": "EMA EMEA/H/C/000805；FDA NDA 021526", "approvalTimeline": [ { "date": "2006-01-27", "title": { "zh": "FDA 批准 RANEXA 500 mg 缓释片", "en": "FDA approved RANEXA 500 mg extended-release tablets" }, "detail": { "zh": "NDA 021526 原始批准信同时保留多个时间点的溶出规格，用于确认缓释产品性能；这不是个人分片或服药时间表。", "en": "The NDA 021526 original approval letter retained multiple dissolution time points to establish extended-release product performance; this is not an individual splitting or dosing schedule." }, "source": { "id": "src_bb114a794784e085", "label": "FDA：RANEXA NDA 021526 原始批准信（2006-01-27；缓释产品溶出要求）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021526_s000_Ranexa_Approv.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "regulatory_approval_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_pdf", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" } }, { "date": "2007-02-12", "title": { "zh": "FDA 批准 1000 mg 历史规格", "en": "FDA approved the historical 1000 mg strength" }, "detail": { "zh": "当前 Orange Book 将 500 与 1000 mg 产品行均列为 Discontinued，且不是 RS。", "en": "Current Orange Book data list both 500 and 1000 mg product rows as Discontinued and not RS." }, "source": { "id": "src_da847698c2fd996c", "label": "FDA Drugs@FDA：RANEXA NDA 021526 申请、历史 RLD 与停止销售状态", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=021526", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_database_record", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" } }, { "date": "2008-07-09", "title": { "zh": "欧盟集中上市许可", "en": "EU central marketing authorisation" }, "detail": { "zh": "EMA 当前 EPAR 列示 RANEXA（原名 Latixa）、雷诺嗪和 EMEA/H/C/000805，当前持有人为 Menarini International Operations Luxembourg S.A.。", "en": "The current EMA EPAR lists RANEXA (previously Latixa), ranolazine and EMEA/H/C/000805, with Menarini International Operations Luxembourg S.A. as the current holder." }, "source": { "id": "src_dda7652ff2b4daab", "label": "EMA：RANEXA（ranolazine）欧盟集中许可 EPAR、公众概要与药物警戒入口", "url": "https://www.ema.europa.eu/en/medicines/human/EPAR/ranexa", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" } } ], "marketStatus": [ { "market": { "zh": "欧盟", "en": "European Union" }, "status": { "zh": "当前集中许可；375、500、750 mg 缓释片", "en": "Current central authorisation; 375, 500 and 750 mg prolonged-release tablets" }, "detail": { "zh": "EMA 的许可与产品资料不证明具体国家药房库存、购买资格、个人适用性或与美国历史强度可换算。", "en": "EMA authorisation and product information do not establish national pharmacy stock, purchasing eligibility, individual suitability or conversion to historical U.S. strengths." } }, { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "500 与 1000 mg 历史 RLD 当前列为 Discontinued", "en": "Historical 500 and 1000 mg RLD products currently listed as Discontinued" }, "detail": { "zh": "2010 DailyMed 两个 60 片瓶装面板只作历史身份与外观核对，不代表当前营销或供应。", "en": "Two 60-tablet bottle panels in the 2010 DailyMed label are retained only for historical identity and appearance review, not ongoing marketing or supply." } }, { "market": { "zh": "中国大陆、日本及其他市场", "en": "Mainland China, Japan and other markets" }, "status": { "zh": "待逐项建立现行市场记录", "en": "Current market records not established" }, "detail": { "zh": "不从欧盟或美国资料推定当地商品名、批准、规格、包装、供应、原研/仿制关系或可替代性。", "en": "No local brand, approval, strength, pack, supply, originator/generic relationship or interchangeability is inferred from EU or U.S. material." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "RANEXA 缓释片能不能掰半或压碎？", "en": "Can a RANEXA prolonged-release tablet be split or crushed?" }, "answer": { "zh": "所引欧盟当前资料和美国历史品牌标签都要求整片吞服，不得压碎、掰开或咀嚼。不要用半片或多片自行拼规格；如吞咽困难，应拿实际药盒让医生或药师重新评估，而不是改变片剂结构。", "en": "The cited current EU information and historical U.S. brand label both say to swallow the tablet whole and not crush, break or chew it. Do not assemble strengths from tablet portions or multiple tablets. For swallowing difficulty, have the actual pack reviewed rather than changing the tablet structure." } }, { "question": { "zh": "胸痛时能不能临时多吃一片 RANEXA？", "en": "Can an extra RANEXA tablet be taken during chest pain?" }, "answer": { "zh": "不能由网页这样决定。美国标签明确提示 RANEXA 不会终止一次急性心绞痛发作；新发、异常、剧烈或持续胸痛应立即按既定急救计划和当地急救系统处理，并说明完整药单。", "en": "A website cannot make that decision. The U.S. label explicitly says RANEXA will not abate an acute angina episode. New, different, severe or persistent chest pain requires the established emergency plan, local emergency services and disclosure of the full medicine list." } }, { "question": { "zh": "服用 RANEXA 前是不是人人都要做全基因筛查？", "en": "Does everyone need whole-genome screening before RANEXA?" }, "answer": { "zh": "所引 EMA 资料没有提出人人进行全基因筛查。它只说明：当 CYP2D6 状态已经通过基因分型获知时，可在存在多项暴露风险因素的患者中帮助专业判断。是否需要任何检测应由医疗团队结合药单、肝肾功能、体重、心电图和病史决定。", "en": "The cited EMA information does not recommend whole-genome screening for everyone. It only notes that already-known CYP2D6 status may help professional caution when several exposure risk factors coexist. Any testing decision belongs with the clinical team after reviewing medicines, liver/kidney function, weight, ECG and history." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "dosage-forms-are-part-of-medicine-identity", "medicine-label-for-everyday-questions", "polypharmacy-safety-guide" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/ranexa/", "en": "https://origindrug.com/en/drugs/ranexa/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "oxycontin", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-30", "status": "published_traceable_archive" }, "names": { "brand": "OXYCONTIN", "generic": "盐酸羟考酮控释片", "aliases": [ "OxyContin", "oxycodone hydrochloride extended-release tablets", "oxycodone ER", "盐酸羟考酮控释片", "羟考酮控释片", "奥施康定", "oxycodone hydrochloride extended-release", "NDA 022272", "NDC 59011-410-10", "NDC 59011-415-10", "NDC 59011-420-10", "NDC 59011-430-10", "NDC 59011-440-10", "NDC 59011-460-10", "NDC 59011-480-10", "OP 10", "OP 15", "OP 20", "OP 30", "OP 40", "OP 60", "OP 80" ], "marketBrandNames": [ { "name": "OXYCONTIN", "market": { "zh": "美国", "en": "United States" }, "evidenceStatus": "current_regulatory_record", "note": { "zh": "当前 DailyMed 标签列示 NDA 022272、CII、七个强度和准确包装；不据此推定实际库存或其他市场状态。", "en": "The current DailyMed label lists NDA 022272, CII, seven strengths and exact packages; it does not establish actual stock or another market's status." }, "source": { "id": "src_2b7fe1b4e3f71fd0", "label": "DailyMed（NLM）：OXYCONTIN 盐酸羟考酮控释片当前美国公开标签（Knoa Pharma；SPL v44，2026-06-24 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=bfdfe235-d717-4855-a3c8-a13d26dadede", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" } } ], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "疼痛与炎症", "sourceArchiveMarket": "美国 DailyMed 当前 OXYCONTIN 标签（SPL v44，2026-06-24 生效）列示 NDA 022272、10/15/20/30/40/60/80 mg 控释片、对应 100 片瓶装和单位剂量包装；本页只展示七个逐一匹配的 100 片瓶装面板。美国 CII 标签、NDA、NDC 或包装图不证明中国大陆或其他市场批准、供应、购买资格、真伪或可替代性。", "dosageFormClass": "盐酸羟考酮薄膜衣控释片；必须整片吞服。不得切开、掰开、咀嚼、碾碎或溶解；普通羟考酮、羟考酮/对乙酰氨基酚复方、另一种羟考酮控释胶囊和历史原配方均不并入本档案。", "dosageFormClassCode": "oral_solid", "route": "口服；必须整片吞服（高风险控释产品身份字段）", "routeCode": "oral", "historicalApprovalEntry": "2010（美国当前重配方 NDA 022272 批准节点；标签所列 1950 是羟考酮的美国初始批准年份，不等同于 OXYCONTIN 品牌年份）", "archiveSponsorText": "Knoa Pharma LLC（当前 DailyMed 标签包装方）；FDA NDA 022272" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [ "OXYCONTIN", "OxyContin", "盐酸羟考酮控释片", "羟考酮控释片", "奥施康定" ], "excludedProductCues": [ "immediate-release oxycodone", "oxycodone immediate-release", "盐酸羟考酮普通片", "PERCOCET", "oxycodone and acetaminophen", "XTAMPZA ER", "oxycodone extended-release capsules", "original OXYCONTIN formulation NDA 020553" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-oxycontin-oxycodone-hydrochloride-er-tablet-10mg-100-bottle-ndc-59011-410-10", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（SPL v44，2026-06-24 生效）", "en": "Current U.S. DailyMed public label (SPL v44, effective 24 Jun 2026)" }, "dosageForm": { "zh": "OXYCONTIN 盐酸羟考酮控释口服片", "en": "OXYCONTIN oxycodone hydrochloride extended-release oral tablet" }, "route": { "zh": "口服；必须整片吞服", "en": "oral; must be swallowed whole" }, "routeCodes": [ "oral" ], "productCode": "NDC 59011-410-10", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片盐酸羟考酮 10 mg；100 片儿童防开启瓶装", "en": "Oxycodone hydrochloride 10 mg per tablet; 100-tablet child-resistant bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=oxycontin-03.jpg&setid=bfdfe235-d717-4855-a3c8-a13d26dadede&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "盐酸羟考酮（每片）", "en": "oxycodone hydrochloride (per tablet)" }, "value": 10, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、频率、转换或补服指令", "en": "labelled amount per tablet; not an individual's tablet count, frequency, conversion or missed-use instruction" } } ], "concentration": null, "container": { "typeCode": "child_resistant_bottle", "typeLabel": { "zh": "儿童防开启瓶", "en": "child-resistant bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-30", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "白色", "en": "white" }, "shape": { "zh": "圆形、双凸、薄膜衣控释片", "en": "round, biconvex, film-coated extended-release tablet" }, "imprint": "OP / 10", "scoreStatus": "not_stated_in_label_whole_tablet_required", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_2b7fe1b4e3f71fd0", "label": "DailyMed（NLM）：OXYCONTIN 盐酸羟考酮控释片当前美国公开标签（Knoa Pharma；SPL v44，2026-06-24 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=bfdfe235-d717-4855-a3c8-a13d26dadede", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-oxycontin-oxycodone-hydrochloride-er-tablet-15mg-100-bottle-ndc-59011-415-10", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（SPL v44，2026-06-24 生效）", "en": "Current U.S. DailyMed public label (SPL v44, effective 24 Jun 2026)" }, "dosageForm": { "zh": "OXYCONTIN 盐酸羟考酮控释口服片", "en": "OXYCONTIN oxycodone hydrochloride extended-release oral tablet" }, "route": { "zh": "口服；必须整片吞服", "en": "oral; must be swallowed whole" }, "routeCodes": [ "oral" ], "productCode": "NDC 59011-415-10", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片盐酸羟考酮 15 mg；100 片儿童防开启瓶装", "en": "Oxycodone hydrochloride 15 mg per tablet; 100-tablet child-resistant bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=oxycontin-04.jpg&setid=bfdfe235-d717-4855-a3c8-a13d26dadede&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "盐酸羟考酮（每片）", "en": "oxycodone hydrochloride (per tablet)" }, "value": 15, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、频率、转换或补服指令", "en": "labelled amount per tablet; not an individual's tablet count, frequency, conversion or missed-use instruction" } } ], "concentration": null, "container": { "typeCode": "child_resistant_bottle", "typeLabel": { "zh": "儿童防开启瓶", "en": "child-resistant bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-30", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "灰色", "en": "gray" }, "shape": { "zh": "圆形、双凸、薄膜衣控释片", "en": "round, biconvex, film-coated extended-release tablet" }, "imprint": "OP / 15", "scoreStatus": "not_stated_in_label_whole_tablet_required", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_2b7fe1b4e3f71fd0", "label": "DailyMed（NLM）：OXYCONTIN 盐酸羟考酮控释片当前美国公开标签（Knoa Pharma；SPL v44，2026-06-24 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=bfdfe235-d717-4855-a3c8-a13d26dadede", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-oxycontin-oxycodone-hydrochloride-er-tablet-20mg-100-bottle-ndc-59011-420-10", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（SPL v44，2026-06-24 生效）", "en": "Current U.S. DailyMed public label (SPL v44, effective 24 Jun 2026)" }, "dosageForm": { "zh": "OXYCONTIN 盐酸羟考酮控释口服片", "en": "OXYCONTIN oxycodone hydrochloride extended-release oral tablet" }, "route": { "zh": "口服；必须整片吞服", "en": "oral; must be swallowed whole" }, "routeCodes": [ "oral" ], "productCode": "NDC 59011-420-10", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片盐酸羟考酮 20 mg；100 片儿童防开启瓶装", "en": "Oxycodone hydrochloride 20 mg per tablet; 100-tablet child-resistant bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=oxycontin-05.jpg&setid=bfdfe235-d717-4855-a3c8-a13d26dadede&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "盐酸羟考酮（每片）", "en": "oxycodone hydrochloride (per tablet)" }, "value": 20, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、频率、转换或补服指令", "en": "labelled amount per tablet; not an individual's tablet count, frequency, conversion or missed-use instruction" } } ], "concentration": null, "container": { "typeCode": "child_resistant_bottle", "typeLabel": { "zh": "儿童防开启瓶", "en": "child-resistant bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-30", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "粉红色", "en": "pink" }, "shape": { "zh": "圆形、双凸、薄膜衣控释片", "en": "round, biconvex, film-coated extended-release tablet" }, "imprint": "OP / 20", "scoreStatus": "not_stated_in_label_whole_tablet_required", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_2b7fe1b4e3f71fd0", "label": "DailyMed（NLM）：OXYCONTIN 盐酸羟考酮控释片当前美国公开标签（Knoa Pharma；SPL v44，2026-06-24 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=bfdfe235-d717-4855-a3c8-a13d26dadede", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-oxycontin-oxycodone-hydrochloride-er-tablet-30mg-100-bottle-ndc-59011-430-10", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（SPL v44，2026-06-24 生效）", "en": "Current U.S. DailyMed public label (SPL v44, effective 24 Jun 2026)" }, "dosageForm": { "zh": "OXYCONTIN 盐酸羟考酮控释口服片", "en": "OXYCONTIN oxycodone hydrochloride extended-release oral tablet" }, "route": { "zh": "口服；必须整片吞服", "en": "oral; must be swallowed whole" }, "routeCodes": [ "oral" ], "productCode": "NDC 59011-430-10", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片盐酸羟考酮 30 mg；100 片儿童防开启瓶装", "en": "Oxycodone hydrochloride 30 mg per tablet; 100-tablet child-resistant bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=oxycontin-06.jpg&setid=bfdfe235-d717-4855-a3c8-a13d26dadede&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "盐酸羟考酮（每片）", "en": "oxycodone hydrochloride (per tablet)" }, "value": 30, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、频率、转换或补服指令", "en": "labelled amount per tablet; not an individual's tablet count, frequency, conversion or missed-use instruction" } } ], "concentration": null, "container": { "typeCode": "child_resistant_bottle", "typeLabel": { "zh": "儿童防开启瓶", "en": "child-resistant bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-30", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "棕色", "en": "brown" }, "shape": { "zh": "圆形、双凸、薄膜衣控释片", "en": "round, biconvex, film-coated extended-release tablet" }, "imprint": "OP / 30", "scoreStatus": "not_stated_in_label_whole_tablet_required", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_2b7fe1b4e3f71fd0", "label": "DailyMed（NLM）：OXYCONTIN 盐酸羟考酮控释片当前美国公开标签（Knoa Pharma；SPL v44，2026-06-24 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=bfdfe235-d717-4855-a3c8-a13d26dadede", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-oxycontin-oxycodone-hydrochloride-er-tablet-40mg-100-bottle-ndc-59011-440-10", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（SPL v44，2026-06-24 生效）", "en": "Current U.S. DailyMed public label (SPL v44, effective 24 Jun 2026)" }, "dosageForm": { "zh": "OXYCONTIN 盐酸羟考酮控释口服片", "en": "OXYCONTIN oxycodone hydrochloride extended-release oral tablet" }, "route": { "zh": "口服；必须整片吞服", "en": "oral; must be swallowed whole" }, "routeCodes": [ "oral" ], "productCode": "NDC 59011-440-10", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片盐酸羟考酮 40 mg；100 片儿童防开启瓶装", "en": "Oxycodone hydrochloride 40 mg per tablet; 100-tablet child-resistant bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=oxycontin-07.jpg&setid=bfdfe235-d717-4855-a3c8-a13d26dadede&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "盐酸羟考酮（每片）", "en": "oxycodone hydrochloride (per tablet)" }, "value": 40, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、频率、转换或补服指令", "en": "labelled amount per tablet; not an individual's tablet count, frequency, conversion or missed-use instruction" } } ], "concentration": null, "container": { "typeCode": "child_resistant_bottle", "typeLabel": { "zh": "儿童防开启瓶", "en": "child-resistant bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-30", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "黄色", "en": "yellow" }, "shape": { "zh": "圆形、双凸、薄膜衣控释片", "en": "round, biconvex, film-coated extended-release tablet" }, "imprint": "OP / 40", "scoreStatus": "not_stated_in_label_whole_tablet_required", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_2b7fe1b4e3f71fd0", "label": "DailyMed（NLM）：OXYCONTIN 盐酸羟考酮控释片当前美国公开标签（Knoa Pharma；SPL v44，2026-06-24 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=bfdfe235-d717-4855-a3c8-a13d26dadede", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-oxycontin-oxycodone-hydrochloride-er-tablet-60mg-100-bottle-ndc-59011-460-10", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（SPL v44，2026-06-24 生效）", "en": "Current U.S. DailyMed public label (SPL v44, effective 24 Jun 2026)" }, "dosageForm": { "zh": "OXYCONTIN 盐酸羟考酮控释口服片", "en": "OXYCONTIN oxycodone hydrochloride extended-release oral tablet" }, "route": { "zh": "口服；必须整片吞服", "en": "oral; must be swallowed whole" }, "routeCodes": [ "oral" ], "productCode": "NDC 59011-460-10", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片盐酸羟考酮 60 mg；100 片儿童防开启瓶装；标签注明仅供已建立阿片耐受者", "en": "Oxycodone hydrochloride 60 mg per tablet; 100-tablet child-resistant bottle; label states for opioid-tolerant patients only" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=oxycontin-08.jpg&setid=bfdfe235-d717-4855-a3c8-a13d26dadede&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "盐酸羟考酮（每片）", "en": "oxycodone hydrochloride (per tablet)" }, "value": 60, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、频率、转换或补服指令", "en": "labelled amount per tablet; not an individual's tablet count, frequency, conversion or missed-use instruction" } } ], "concentration": null, "container": { "typeCode": "child_resistant_bottle", "typeLabel": { "zh": "儿童防开启瓶", "en": "child-resistant bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-30", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "红色", "en": "red" }, "shape": { "zh": "圆形、双凸、薄膜衣控释片", "en": "round, biconvex, film-coated extended-release tablet" }, "imprint": "OP / 60", "scoreStatus": "not_stated_in_label_whole_tablet_required", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_2b7fe1b4e3f71fd0", "label": "DailyMed（NLM）：OXYCONTIN 盐酸羟考酮控释片当前美国公开标签（Knoa Pharma；SPL v44，2026-06-24 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=bfdfe235-d717-4855-a3c8-a13d26dadede", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-oxycontin-oxycodone-hydrochloride-er-tablet-80mg-100-bottle-ndc-59011-480-10", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（SPL v44，2026-06-24 生效）", "en": "Current U.S. DailyMed public label (SPL v44, effective 24 Jun 2026)" }, "dosageForm": { "zh": "OXYCONTIN 盐酸羟考酮控释口服片", "en": "OXYCONTIN oxycodone hydrochloride extended-release oral tablet" }, "route": { "zh": "口服；必须整片吞服", "en": "oral; must be swallowed whole" }, "routeCodes": [ "oral" ], "productCode": "NDC 59011-480-10", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片盐酸羟考酮 80 mg；100 片儿童防开启瓶装；标签注明仅供已建立阿片耐受者", "en": "Oxycodone hydrochloride 80 mg per tablet; 100-tablet child-resistant bottle; label states for opioid-tolerant patients only" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=oxycontin-09.jpg&setid=bfdfe235-d717-4855-a3c8-a13d26dadede&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "盐酸羟考酮（每片）", "en": "oxycodone hydrochloride (per tablet)" }, "value": 80, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、频率、转换或补服指令", "en": "labelled amount per tablet; not an individual's tablet count, frequency, conversion or missed-use instruction" } } ], "concentration": null, "container": { "typeCode": "child_resistant_bottle", "typeLabel": { "zh": "儿童防开启瓶", "en": "child-resistant bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-30", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "绿色", "en": "green" }, "shape": { "zh": "圆形、双凸、薄膜衣控释片", "en": "round, biconvex, film-coated extended-release tablet" }, "imprint": "OP / 80", "scoreStatus": "not_stated_in_label_whole_tablet_required", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_2b7fe1b4e3f71fd0", "label": "DailyMed（NLM）：OXYCONTIN 盐酸羟考酮控释片当前美国公开标签（Knoa Pharma；SPL v44，2026-06-24 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=bfdfe235-d717-4855-a3c8-a13d26dadede", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-oxycontin-oxycodone-hydrochloride-er-tablet-10mg-100-bottle-ndc-59011-410-10", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=oxycontin-03.jpg&setid=bfdfe235-d717-4855-a3c8-a13d26dadede&type=img", "alt": "OXYCONTIN 盐酸羟考酮控释片 10 mg、NDC 59011-410-10、100 片瓶装在美国 DailyMed 当前标签中的准确包装图", "archiveMarket": "美国", "labelVersion": "DailyMed SPL v44（2026-06-24 生效）", "presentation": "OXYCONTIN 10 mg 控释片；NDC 59011-410-10；100 片儿童防开启瓶装", "notice": "此图只对应所引当前美国标签中的 OXYCONTIN 10 mg、NDC 59011-410-10 和 100 片瓶装。它不用于鉴定真伪，不代表个人适用、片数、频率、换算、减量、停药、购买资格或其他强度/市场包装。", "source": { "id": "src_2b7fe1b4e3f71fd0", "label": "DailyMed（NLM）：OXYCONTIN 盐酸羟考酮控释片当前美国公开标签（Knoa Pharma；SPL v44，2026-06-24 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=bfdfe235-d717-4855-a3c8-a13d26dadede", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "OXYCONTIN 说明书放大阅读：控释片必须整片吞服，先防呼吸抑制与重复镇静", "en": "OXYCONTIN label reading: swallow the extended-release tablet whole and prioritise respiratory-depression and duplicate-sedation risks" }, "summary": { "zh": "本模块放大阅读当前美国标签中的准确控释片、包装、整片边界和高风险药单线索；不决定个人是否使用，也不生成片数、频率、转换、开始、补服、减量或停药方案。", "en": "This module enlarges the exact extended-release tablet, package, whole-tablet boundary and high-risk medicine-list cues in the current U.S. label. It does not decide individual use or generate tablet count, frequency, conversion, initiation, missed-use, tapering or stopping." }, "checks": [ { "zh": "OXYCONTIN 是控释片，必须整片吞服。切开、掰开、咀嚼、碾碎或溶解会破坏控释，可能造成羟考酮快速释放并暴露于潜在致命剂量；片上没有被标签描述为可自行分片的刻痕。吞咽困难时不要自行改造药片，应联系开方团队或药师。", "en": "OXYCONTIN is an extended-release tablet and must be swallowed whole. Cutting, breaking, chewing, crushing or dissolving can defeat the controlled release and expose a person to a potentially fatal oxycodone dose; the label does not describe a self-splitting score. If swallowing is difficult, do not alter the tablet—contact the prescriber or pharmacist." }, { "zh": "严重、危及生命或致命的呼吸抑制可发生，开始使用或调整后尤其需要专业监测。老年、虚弱、慢性肺病、呼吸储备下降者，以及出现异常嗜睡、叫不醒、呼吸慢浅、嘴唇发青或意识改变者风险更值得优先处理；严重表现应立即使用当地急救服务。", "en": "Serious, life-threatening or fatal respiratory depression can occur and requires particular professional monitoring after initiation or change. Older, frail people, those with chronic lung disease or reduced respiratory reserve, and anyone with unusual sleepiness, difficulty waking, slow or shallow breathing, blue lips or altered consciousness need priority attention; severe signs require local emergency services immediately." }, { "zh": "苯二氮卓类安眠/抗焦虑药、其他镇静催眠药、其他阿片、麻醉药、部分抗精神病药、加巴喷丁类药物和酒精等中枢抑制物与 OXYCONTIN 同在药单时，可能增加深度镇静、呼吸抑制、昏迷和死亡风险。不要因服用时间错开就认定安全；请把所有处方药、非处方药、酒精和补充剂放在同一张清单交给医生或药师核对。", "en": "Benzodiazepine sleeping/anxiety medicines, other sedative-hypnotics, other opioids, anaesthetics, some antipsychotics, gabapentinoids and alcohol can increase profound sedation, respiratory depression, coma and death when present with OXYCONTIN. Separating clock times does not establish safety; place every prescription, OTC medicine, alcohol exposure and supplement on one list for a clinician or pharmacist." }, { "zh": "标签把 60 mg、80 mg 以及某些更高暴露情境限定给已建立相应阿片耐受者。‘以前吃过止痛药’、体重、疼痛评分或手中还有旧药，都不能由网页判断为已经耐受；不要自行升级强度、换算另一种阿片或使用他人的药。", "en": "The label restricts 60 mg, 80 mg and certain higher-exposure situations to people with established opioid tolerance. Prior pain-medicine use, body weight, a pain score or leftover tablets cannot let a webpage establish tolerance; do not self-escalate strength, convert another opioid or use another person's medicine." }, { "zh": "儿童或未被开具者意外摄入一片也可能致命。药品应上锁、远离儿童和访客，按当地药品回收或官方处置要求处理；不得分享、转赠或保留在无人管理的位置。若怀疑意外摄入，不要等待症状或网页判断，立即联系当地急救/毒物咨询渠道。", "en": "Accidental ingestion of even one tablet by a child or person for whom it was not prescribed can be fatal. Store it locked away from children and visitors, use local take-back or official disposal routes, and never share, give away or leave it unsecured. If accidental ingestion is suspected, do not wait for symptoms or a webpage—contact local emergency/poison services immediately." }, { "zh": "强 CYP3A4 抑制剂或诱导剂的开始、停用或变化可能改变羟考酮暴露；影响血清素的药可能带来血清素综合征风险；MAO 抑制剂及其近期使用也需要严格核对。不要根据药名类别自行错开、停换或调整任何一种药。", "en": "Starting, stopping or changing a strong CYP3A4 inhibitor or inducer may alter oxycodone exposure; serotonergic medicines may contribute to serotonin syndrome; MAO inhibitors and recent MAO-inhibitor use also require strict review. Do not self-separate, stop, switch or adjust any medicine from a class name." }, { "zh": "便秘、腹胀、呕吐或疑似肠梗阻需要及时评估；已知或疑似胃肠道梗阻是标签禁忌。网页不能区分普通便秘、阿片相关问题或急腹症，也不能代替临床检查。", "en": "Constipation, distension, vomiting or suspected obstruction needs prompt assessment; known or suspected gastrointestinal obstruction is a labelled contraindication. A webpage cannot distinguish ordinary constipation, an opioid-related problem or an acute abdomen and cannot replace examination." }, { "zh": "纳洛酮可用于阿片过量紧急处置，但是否需要配备、如何获得和怎样使用应由当地医疗或药学团队结合具体情况讲解。出现叫不醒、呼吸异常或疑似过量时，应立即呼叫当地急救服务，不要只依赖网页或家属观察。", "en": "Naloxone can be used in an opioid-overdose emergency, but whether to have it, how to obtain it and how to use it requires local clinical or pharmacy instruction. If a person cannot be awakened, has abnormal breathing or an overdose is suspected, call local emergency services immediately rather than relying only on a webpage or household observation." } ], "source": { "id": "src_2b7fe1b4e3f71fd0", "label": "DailyMed（NLM）：OXYCONTIN 盐酸羟考酮控释片当前美国公开标签（Knoa Pharma；SPL v44，2026-06-24 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=bfdfe235-d717-4855-a3c8-a13d26dadede", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "羟考酮怎样起作用：阿片受体激动与控释技术不能变成个人换算规则", "en": "How oxycodone works: opioid-receptor agonism and extended release are not personal conversion rules" }, "summary": { "zh": "当前标签把羟考酮描述为阿片受体激动剂，并把 OXYCONTIN 设计为控释片。药理和释放方式可以解释镇痛、嗜睡、呼吸抑制、便秘与依赖风险，却不能推导个人应服几片、与另一种阿片如何换算、能否掰片或何时减停。", "en": "The current label describes oxycodone as an opioid agonist and OXYCONTIN as an extended-release tablet. Pharmacology and release design help explain analgesia, sedation, respiratory depression, constipation and dependence risk, but cannot derive an individual's tablet count, conversion from another opioid, splitting or taper/stopping timing." }, "checks": [ { "zh": "“控释”表示药片释放设计是产品身份的一部分，不等于药效更温和或风险更低；破坏药片可把释放特性变成危险暴露。", "en": "Extended release means the release design is part of product identity; it does not mean milder effects or lower risk. Altering the tablet can turn its release characteristics into dangerous exposure." }, { "zh": "共同成分或同属阿片类不表示 OXYCONTIN 与普通羟考酮、复方羟考酮、芬太尼贴剂、吗啡或另一控释产品可按毫克自行替换、叠加或轮换。", "en": "A shared ingredient or opioid class does not make OXYCONTIN self-convertible, combinable or alternatable by milligrams with immediate-release oxycodone, an oxycodone combination, fentanyl patch, morphine or another extended-release product." }, { "zh": "出现疼痛加重、异常嗜睡、呼吸变化、跌倒、意识变化或戒断样不适时，机制页不能判断原因。不要同时改变多种药，应联系开方团队；急性严重表现使用当地急救服务。", "en": "A mechanism page cannot determine the cause of worsening pain, unusual sleepiness, breathing change, a fall, altered consciousness or withdrawal-like symptoms. Do not change several medicines at once; contact the prescribing team and use local emergency services for acute severe signs." } ], "source": { "id": "src_2b7fe1b4e3f71fd0", "label": "DailyMed（NLM）：OXYCONTIN 盐酸羟考酮控释片当前美国公开标签（Knoa Pharma；SPL v44，2026-06-24 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=bfdfe235-d717-4855-a3c8-a13d26dadede", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "OXYCONTIN", "generic": "盐酸羟考酮控释片", "dosageFormClass": "盐酸羟考酮薄膜衣控释片；必须整片吞服。不得切开、掰开、咀嚼、碾碎或溶解；普通羟考酮、羟考酮/对乙酰氨基酚复方、另一种羟考酮控释胶囊和历史原配方均不并入本档案。" }, "labelSource": { "id": "src_2b7fe1b4e3f71fd0", "label": "DailyMed（NLM）：OXYCONTIN 盐酸羟考酮控释片当前美国公开标签（Knoa Pharma；SPL v44，2026-06-24 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=bfdfe235-d717-4855-a3c8-a13d26dadede", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "productRoutes": [ { "source": { "id": "src_2b7fe1b4e3f71fd0", "label": "DailyMed（NLM）：OXYCONTIN 盐酸羟考酮控释片当前美国公开标签（Knoa Pharma；SPL v44，2026-06-24 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=bfdfe235-d717-4855-a3c8-a13d26dadede", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-30", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-30", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "OXYCONTIN 是盐酸羟考酮控释片，是美国 CII 管制的长效阿片类处方药。最重要的三件事是：它不是普通速释羟考酮，也不是临时按需止痛药；必须整片吞服，破坏控释片可能一次释放潜在致命剂量；与酒精、安眠镇静药或其他抑制中枢的药同在一张药单时，嗜睡和呼吸抑制风险必须由专业人员核对。网页只帮助识别包装、说明书和风险，不提供个人片数、频率、换算、减量或停药方案。", "history": "FDA 2010 年 NDA 022272 医学审评资料记录了抗滥用重配方 OXYCONTIN 的监管背景，并与历史原配方 NDA 020553 分开。当前 DailyMed SPL v44 于 2026-06-24 生效，列示 10、15、20、30、40、60、80 mg 七种控释片；标签所列 Initial U.S. Approval: 1950 指羟考酮成分的美国初始批准节点，不能写成 OXYCONTIN 品牌于 1950 年获批。", "sourceDocuments": [ { "id": "src_2b7fe1b4e3f71fd0", "label": "DailyMed（NLM）：OXYCONTIN 盐酸羟考酮控释片当前美国公开标签（Knoa Pharma；SPL v44，2026-06-24 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=bfdfe235-d717-4855-a3c8-a13d26dadede", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, { "id": "src_240f6a672cb5e35b", "label": "FDA：OXYCONTIN 现行重配方 NDA 022272 医学审评资料（2010）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022272s000MedR.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "regulatory_review", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_pdf", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" } ], "applicationNumber": "FDA NDA 022272（当前重配方 OXYCONTIN）", "approvalTimeline": [ { "date": "1950", "title": { "zh": "羟考酮的美国初始批准年份", "en": "Initial U.S. approval year for oxycodone" }, "detail": { "zh": "当前标签列出 Initial U.S. Approval: 1950；该年份属于活性成分历史，不写成 OXYCONTIN 品牌或当前重配方的批准年份。", "en": "The current label states Initial U.S. Approval: 1950; this is active-ingredient history and is not presented as the approval year for the OXYCONTIN brand or current reformulation." }, "source": { "id": "src_2b7fe1b4e3f71fd0", "label": "DailyMed（NLM）：OXYCONTIN 盐酸羟考酮控释片当前美国公开标签（Knoa Pharma；SPL v44，2026-06-24 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=bfdfe235-d717-4855-a3c8-a13d26dadede", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" } }, { "date": "2010", "title": { "zh": "当前重配方 NDA 022272 审评节点", "en": "Current reformulation NDA 022272 review milestone" }, "detail": { "zh": "FDA 医学审评资料将 NDA 022272 的重配方与历史原配方 NDA 020553 分开，并说明其提高抗物理/化学篡改能力的监管背景。", "en": "FDA medical-review material distinguishes the NDA 022272 reformulation from historical original formulation NDA 020553 and describes its greater resistance to physical and chemical manipulation." }, "source": { "id": "src_240f6a672cb5e35b", "label": "FDA：OXYCONTIN 现行重配方 NDA 022272 医学审评资料（2010）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022272s000MedR.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "regulatory_review", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_pdf", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" } }, { "date": "2026-06-24", "title": { "zh": "当前公开标签生效", "en": "Current public label effective" }, "detail": { "zh": "DailyMed SPL v44 列示七种强度、十四个 NDC（瓶装与单位剂量包装）及现行安全信息；本页只逐一展示七个 100 片瓶装。", "en": "DailyMed SPL v44 lists seven strengths, fourteen NDCs (bottles and unit-dose packs) and current safety information; this page maps only the seven 100-tablet bottles one to one." }, "source": { "id": "src_2b7fe1b4e3f71fd0", "label": "DailyMed（NLM）：OXYCONTIN 盐酸羟考酮控释片当前美国公开标签（Knoa Pharma；SPL v44，2026-06-24 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=bfdfe235-d717-4855-a3c8-a13d26dadede", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "当前 NDA 标签和七个准确瓶装面板已建立", "en": "Current NDA label and seven exact bottle panels established" }, "detail": { "zh": "准确标签和 NDC 不等于实际库存、购买资格、个人适用性或可替代性。", "en": "An exact label and NDC do not establish actual stock, purchase eligibility, individual suitability or interchangeability." } }, { "market": { "zh": "中国大陆及其他市场", "en": "Mainland China and other markets" }, "status": { "zh": "现行监管记录待逐项建立", "en": "Current regulatory records not yet established" }, "detail": { "zh": "不从美国商品名、共同成分或包装外观推定当地批准、商品名、供应、原研/仿制关系或合法购药渠道。", "en": "No local approval, trade name, supply, originator/generic relationship or lawful purchase channel is inferred from the U.S. name, shared ingredient or package appearance." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "药片太大，可以掰开或碾碎吗？", "en": "Can a large tablet be split or crushed?" }, "answer": { "zh": "不可以根据网页或外观自行这样做。当前标签要求整片吞服；切开、掰开、咀嚼、碾碎或溶解可能释放潜在致命剂量。吞咽困难应立即联系开方团队或药师讨论安全替代方案。", "en": "Do not do this from a webpage or appearance. The current label requires swallowing whole; cutting, breaking, chewing, crushing or dissolving may release a potentially fatal dose. Contact the prescriber or pharmacist promptly about a safe alternative if swallowing is difficult." } }, { "question": { "zh": "晚上再吃安眠药，错开时间就安全吗？", "en": "Is a sleeping medicine safe if taken at a different time?" }, "answer": { "zh": "网页不能这样判断。苯二氮卓类、其他镇静药、酒精和其他中枢抑制物可能与 OXYCONTIN 共同增加深度镇静、呼吸抑制、昏迷和死亡风险；错开时间本身不证明安全，应核对完整药单。", "en": "A webpage cannot establish that. Benzodiazepines, other sedatives, alcohol and other CNS depressants may add to profound sedation, respiratory depression, coma and death with OXYCONTIN; separating times does not prove safety, so the full list needs review." } }, { "question": { "zh": "10 mg 和 20 mg 看起来只差一倍，可以自行换算片数吗？", "en": "Can 10 mg and 20 mg be converted by tablet count because one is double?" }, "answer": { "zh": "不能。标签强度是每片产品身份，不是个人换算器。阿片转换、耐受、合并用药、肝肾/肺部状况和停药风险都需专业评估；不要自行叠加、减半、轮换或使用他人的药。", "en": "No. Labelled strength is a per-tablet identity, not a personal converter. Opioid conversion, tolerance, co-medication, hepatic/renal/pulmonary status and stopping risk require professional assessment; do not self-combine, halve, alternate or use another person's medicine." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "dosage-forms-are-part-of-medicine-identity", "polypharmacy-safety-guide", "family-medicine-list-for-pharmacist" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/oxycontin/", "en": "https://origindrug.com/en/drugs/oxycontin/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "ultram", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-30", "status": "published_traceable_archive" }, "names": { "brand": "ULTRAM", "generic": "盐酸曲马多片", "aliases": [ "Ultram", "tramadol hydrochloride", "tramadol", "盐酸曲马多片", "曲马多片", "曲马多", "NDA 020281", "ANDA 076003", "50458-659-60", "60219-2348-1", "ULTRAM 06 59", "AN 627" ], "marketBrandNames": [ { "name": "ULTRAM", "market": { "zh": "美国（历史）", "en": "United States (historical)" }, "evidenceStatus": "historical_public_record", "note": { "zh": "历史品牌 50 mg、100 片瓶装；已停止营销并撤回 NDA，不代表当前供应。", "en": "Historical 50 mg brand product in a 100-tablet bottle; marketing ended and the NDA was withdrawn, so this is not current-supply evidence." }, "source": { "id": "src_b4e1e8bd42b55fe9", "label": "DailyMed（NLM）：ULTRAM 曲马多盐酸盐 50 mg 历史美国品牌标签（Janssen；NDA 020281；2023-03 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/downloadpdffile.cfm?setId=45f59e6f-1794-40a4-8f8b-3a9415924468", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_pdf", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" } } ], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "疼痛与炎症", "sourceArchiveMarket": "美国历史 ULTRAM 品牌标签列示曲马多盐酸盐 50 mg、NDC 50458-659-60、100 片瓶装，营销终止日为 2022-09-30；FDA 记录 NDA 020281 于 2023-10-05 撤回，并注明不是因安全性或有效性原因撤市。当前 Amneal 通用药标签另列 50 mg、NDC 60219-2348-1、100 片瓶装。本页把历史品牌和当前 ANDA 比较项分开，不证明实时库存、购买资格、中国大陆或其他市场批准、真伪或可替代性。", "dosageFormClass": "曲马多盐酸盐即释包衣口服片：历史 ULTRAM 与当前 Amneal 通用药比较项均为每片 50 mg；ULTRACET 复方、ULTRAM ER／其他缓释曲马多及其他阿片产品不并入本档案。刻痕只作为产品身份线索，不自动构成可自行分片许可。", "dosageFormClassCode": "oral_modified_release", "route": "口服（高风险即释阿片产品身份字段）", "routeCode": "oral", "historicalApprovalEntry": "1995（当前通用药标签所列美国初始批准；ULTRAM NDA 020281 已于 2023-10-05 撤回）", "archiveSponsorText": "Janssen Pharmaceuticals, Inc.（历史 ULTRAM NDA 020281）；Amneal Pharmaceuticals NY LLC（当前 ANDA 076003 比较项）" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [ "ULTRAM", "Ultram", "盐酸曲马多片", "曲马多片" ], "excludedProductCues": [ "ULTRACET", "tramadol and acetaminophen", "曲马多对乙酰氨基酚复方", "ULTRAM ER", "tramadol extended-release", "曲马多缓释片" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-ultram-tramadol-hydrochloride-50mg-100-bottle-ndc-50458-659-60-historical", "marketCode": "US", "labelVersion": { "zh": "DailyMed 历史美国品牌标签（2023-03 修订；营销终止 2022-09-30）", "en": "Historical U.S. DailyMed brand label (revised Mar 2023; marketing ended 30 Sep 2022)" }, "dosageForm": { "zh": "ULTRAM 曲马多盐酸盐包衣口服片", "en": "ULTRAM tramadol hydrochloride coated oral tablet" }, "route": { "zh": "口服（历史品牌产品身份字段）", "en": "oral (historical brand product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 50458-659-60", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片曲马多盐酸盐 50 mg；100 片瓶装；美国历史品牌产品", "en": "Tramadol hydrochloride 50 mg per tablet; 100-tablet bottle; historical U.S. brand product" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "曲马多盐酸盐", "en": "tramadol hydrochloride" }, "value": 50, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片历史标签标示量；不是个人片数、频率、疗程、转换或补服指令", "en": "historical labelled amount per tablet; not an individual's tablet count, frequency, course, conversion or missed-use instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-30", "currentLabelDisplayed": false, "ndcDirectoryListed": false, "marketAvailability": "marketing_ended", "marketingStartDate": null, "marketingEndDate": "2022-09-30", "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "白色", "en": "white" }, "shape": { "zh": "椭圆形（胶囊形）包衣片", "en": "oval (capsule-shaped) coated tablet" }, "imprint": "ULTRAM / 06 / 59", "scoreStatus": "scored_status_not_a_split_instruction", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_b4e1e8bd42b55fe9", "label": "DailyMed（NLM）：ULTRAM 曲马多盐酸盐 50 mg 历史美国品牌标签（Janssen；NDA 020281；2023-03 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/downloadpdffile.cfm?setId=45f59e6f-1794-40a4-8f8b-3a9415924468", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_pdf", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-amneal-tramadol-hydrochloride-50mg-100-bottle-ndc-60219-2348-1-current-anda", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国通用药标签（SPL v4，2026-05-21 发布）", "en": "Current U.S. DailyMed generic label (SPL v4, published 21 May 2026)" }, "dosageForm": { "zh": "Amneal 曲马多盐酸盐 50 mg 包衣口服片（通用药比较项）", "en": "Amneal tramadol hydrochloride 50 mg coated oral tablet (generic comparator)" }, "route": { "zh": "口服（当前通用药产品身份字段）", "en": "oral (current generic product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 60219-2348-1", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片曲马多盐酸盐 50 mg；100 片瓶装；ANDA 076003 通用药比较项", "en": "Tramadol hydrochloride 50 mg per tablet; 100-tablet bottle; ANDA 076003 generic comparator" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=tramadol-hydrochloride-tablets-usp-50-mg-4.jpg&setid=8ec4e4e5-a56e-4198-8428-6b770b9bf27d&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "曲马多盐酸盐", "en": "tramadol hydrochloride" }, "value": 50, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片当前标签标示量；不是个人片数、频率、疗程、转换或补服指令", "en": "current labelled amount per tablet; not an individual's tablet count, frequency, course, conversion or missed-use instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-30", "currentLabelDisplayed": true, "ndcDirectoryListed": false, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "白色", "en": "white" }, "shape": { "zh": "圆形薄膜衣片", "en": "round film-coated tablet" }, "imprint": "AN / 627", "scoreStatus": "scored_status_not_a_split_instruction", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_defef78920be450d", "label": "DailyMed（NLM）：曲马多盐酸盐 50 mg 当前美国通用药标签（Amneal；SPL v4，2026-05-21 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8ec4e4e5-a56e-4198-8428-6b770b9bf27d", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-amneal-tramadol-hydrochloride-50mg-100-bottle-ndc-60219-2348-1-current-anda", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=tramadol-hydrochloride-tablets-usp-50-mg-4.jpg&setid=8ec4e4e5-a56e-4198-8428-6b770b9bf27d&type=img", "alt": "Amneal 曲马多盐酸盐 50 mg、NDC 60219-2348-1、100 片瓶装当前美国通用药标签面板", "archiveMarket": "美国", "labelVersion": "DailyMed 当前通用药 SPL v4（2026-05-21 发布）", "presentation": "Amneal 曲马多盐酸盐 50 mg；NDC 60219-2348-1；100 片瓶装；ANDA 076003 比较项", "notice": "此图是当前美国通用药比较项，不是历史 ULTRAM 原品牌包装图。它只对应所引 NDC、强度和瓶装，不用于鉴定真伪，也不证明当前库存、购买资格、个人适用或可与 ULTRAM、ULTRAM ER、ULTRACET 或其他阿片自行替换。", "source": { "id": "src_defef78920be450d", "label": "DailyMed（NLM）：曲马多盐酸盐 50 mg 当前美国通用药标签（Amneal；SPL v4，2026-05-21 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8ec4e4e5-a56e-4198-8428-6b770b9bf27d", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "ULTRAM／曲马多说明书放大阅读：先核对镇静、呼吸、癫痫与血清素风险", "en": "ULTRAM / tramadol label reading: prioritise sedation, breathing, seizure and serotonin risks" }, "summary": { "zh": "本模块用历史品牌身份和当前通用药标签解释即释曲马多的准确产品边界与高风险药单线索；不决定个人是否使用，也不生成片数、频率、疗程、转换、补服、减量或停药方案。", "en": "This module combines the historical brand identity with a current generic label to explain immediate-release tramadol and higher-risk medicine-list cues. It does not decide individual use or generate tablet count, frequency, course, conversion, missed-use, tapering or stopping." }, "checks": [ { "zh": "异常嗜睡、叫不醒、呼吸慢浅、嘴唇发青、意识改变或疑似误服／过量属于急症线索，应立即使用当地急救或毒物咨询服务。老人、虚弱者、慢性肺病患者和同时使用镇静药者尤其需要优先核对。", "en": "Unusual sleepiness, inability to wake, slow or shallow breathing, blue lips, altered consciousness or suspected accidental ingestion/overdose are emergency cues requiring local emergency or poison services. Older or frail people, those with chronic lung disease and people also taking sedatives need priority review." }, { "zh": "苯二氮卓类安眠／抗焦虑药、其他镇静催眠药、酒精、加巴喷丁类、其他阿片或麻醉药可能共同增加深度镇静、呼吸抑制、昏迷和死亡风险。错开时间不自动证明安全，必须核对完整药单。", "en": "Benzodiazepine sleeping/anxiety medicines, other sedative-hypnotics, alcohol, gabapentinoids, other opioids or anaesthetics may add to profound sedation, respiratory depression, coma and death. Separating clock times does not prove safety; review the complete medicine list." }, { "zh": "部分 SSRI、SNRI、三环类抗抑郁药、曲普坦、MAO 抑制剂、利奈唑胺、锂盐、圣约翰草及其他影响血清素的药可能增加血清素综合征风险。躁动、发热、多汗、震颤、肌肉僵硬、腹泻或意识变化等组合表现需要及时医疗评估，严重时使用急救服务。", "en": "Some SSRIs, SNRIs, tricyclic antidepressants, triptans, MAO inhibitors, linezolid, lithium, St John's wort and other serotonergic medicines may increase serotonin-syndrome risk. A combination of agitation, fever, sweating, tremor, muscle rigidity, diarrhoea or mental-status change needs prompt medical assessment and emergency services if severe." }, { "zh": "曲马多可增加癫痫发作风险；既往癫痫、头部损伤、戒酒／戒镇静药，或同用会降低惊厥阈值的药时更需要专业核对。不要因疼痛加重自行叠加片数或与另一止痛药轮换。", "en": "Tramadol can increase seizure risk. A seizure history, head injury, alcohol/sedative withdrawal or another medicine that lowers the seizure threshold requires professional review. Do not self-add tablets or alternate another pain medicine because pain worsens." }, { "zh": "CYP2D6 与 CYP3A4 相关药物或个体代谢差异可能改变曲马多及其活性代谢物暴露；这不是让网页根据基因、药名或症状计算个人用法的依据。是否需要药物基因检测必须结合临床问题由专业人员判断。", "en": "CYP2D6- and CYP3A4-related medicines or metabolic variation can alter tramadol and active-metabolite exposure. This does not let a webpage calculate individual use from a gene, medicine name or symptom. Whether pharmacogenetic testing is useful requires a specific clinical question and professional judgement." }, { "zh": "历史 ULTRAM 与当前通用药片都有刻痕记录，但刻痕不是对所有人自行掰片、减半、拼规格或改变频率的通用许可。请以手中准确产品的当前说明书、处方和药师／医生核对为准。", "en": "Both the historical ULTRAM and current generic tablet have scored appearances, but a score is not universal permission to split, halve, assemble a strength or change frequency. Use the current label for the exact product in hand and the prescription, pharmacist or clinician review." }, { "zh": "儿童或未被开具者误服可能致命。药品应上锁、不得分享，并按当地回收或官方处置渠道处理；怀疑误服时不要等待网页判断。", "en": "Accidental ingestion by a child or person for whom it was not prescribed can be fatal. Store it locked, never share it and use local take-back or official disposal routes; do not wait for a webpage if ingestion is suspected." } ], "source": { "id": "src_defef78920be450d", "label": "DailyMed（NLM）：曲马多盐酸盐 50 mg 当前美国通用药标签（Amneal；SPL v4，2026-05-21 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8ec4e4e5-a56e-4198-8428-6b770b9bf27d", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "曲马多怎样起作用：弱阿片受体作用与单胺再摄取影响不能变成个人换算表", "en": "How tramadol works: opioid-receptor activity and monoamine-reuptake effects are not a personal conversion table" }, "summary": { "zh": "曲马多及其活性代谢物具有阿片受体相关作用，同时影响去甲肾上腺素和血清素再摄取。这能解释镇痛、嗜睡、呼吸抑制、癫痫和血清素风险，却不能推导个人应服几片、与另一阿片如何换算、是否需要基因筛查或何时减停。", "en": "Tramadol and its active metabolite have opioid-receptor activity and also affect norepinephrine and serotonin reuptake. This helps explain analgesia, sedation, respiratory depression, seizure and serotonin risks, but cannot derive an individual's tablet count, conversion from another opioid, need for genetic screening or taper/stopping timing." }, "checks": [ { "zh": "“作用较弱”不等于没有阿片风险；同类、共同用途或相近毫克数也不表示可与 OXYCONTIN、可待因、吗啡或其他止痛药自行叠加、轮换或替换。", "en": "‘Weaker’ does not mean free of opioid risk. A shared class, purpose or similar milligram number does not permit self-combination, alternation or substitution with OXYCONTIN, codeine, morphine or another pain medicine." }, { "zh": "CYP2D6 差异可能改变活性代谢物形成，但基因结果不是单独的选药或片数答案；还需准确产品、完整药单、肝肾功能、呼吸状况与治疗目标。", "en": "CYP2D6 variation may alter active-metabolite formation, but a gene result alone is not a medicine-selection or tablet-count answer. The exact product, full medicine list, hepatic/renal and respiratory status and treatment goal still matter." }, { "zh": "出现疼痛变化、嗜睡、跌倒、意识或呼吸改变、震颤、发热或疑似戒断时，机制页不能判断原因。不要同时改变多种药；联系负责治疗的团队，严重表现使用当地急救服务。", "en": "A mechanism page cannot determine the cause of pain change, sleepiness, a fall, altered consciousness or breathing, tremor, fever or suspected withdrawal. Do not change several medicines at once; contact the treating team and use local emergency services for severe signs." } ], "source": { "id": "src_defef78920be450d", "label": "DailyMed（NLM）：曲马多盐酸盐 50 mg 当前美国通用药标签（Amneal；SPL v4，2026-05-21 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8ec4e4e5-a56e-4198-8428-6b770b9bf27d", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "ULTRAM", "generic": "盐酸曲马多片", "dosageFormClass": "曲马多盐酸盐即释包衣口服片：历史 ULTRAM 与当前 Amneal 通用药比较项均为每片 50 mg；ULTRACET 复方、ULTRAM ER／其他缓释曲马多及其他阿片产品不并入本档案。刻痕只作为产品身份线索，不自动构成可自行分片许可。" }, "labelSource": { "id": "src_defef78920be450d", "label": "DailyMed（NLM）：曲马多盐酸盐 50 mg 当前美国通用药标签（Amneal；SPL v4，2026-05-21 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8ec4e4e5-a56e-4198-8428-6b770b9bf27d", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "productRoutes": [ { "source": { "id": "src_defef78920be450d", "label": "DailyMed（NLM）：曲马多盐酸盐 50 mg 当前美国通用药标签（Amneal；SPL v4，2026-05-21 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8ec4e4e5-a56e-4198-8428-6b770b9bf27d", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-30", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_b4e1e8bd42b55fe9", "label": "DailyMed（NLM）：ULTRAM 曲马多盐酸盐 50 mg 历史美国品牌标签（Janssen；NDA 020281；2023-03 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/downloadpdffile.cfm?setId=45f59e6f-1794-40a4-8f8b-3a9415924468", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_pdf", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-30", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-30", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "ULTRAM 是美国历史曲马多盐酸盐 50 mg 即释品牌片，品牌产品已停止营销并撤回 NDA；美国仍有通用药标签作为当前安全阅读比较项。曲马多既有阿片相关的嗜睡、呼吸抑制、依赖和误服风险，也会影响去甲肾上腺素和血清素通路，因此与安眠镇静药、酒精、其他阿片、部分抗抑郁药或诱发癫痫的药同在一张药单时必须优先核对。网页只帮助识别产品和风险，不提供个人片数、频率、换算、加减量或停药方案。", "history": "ULTRAM NDA 020281 于 1995 年进入美国市场；历史 DailyMed 标签记录 50 mg、NDC 50458-659-60、100 片瓶装和 2022-09-30 营销终止日。FDA 后续审评记载 NDA 于 2023-10-05 撤回，并说明不是因安全性或有效性原因撤市。当前标签阅读采用 2026 年 Amneal ANDA 076003 通用药资料，并与历史品牌包装身份明确分开。", "sourceDocuments": [ { "id": "src_b4e1e8bd42b55fe9", "label": "DailyMed（NLM）：ULTRAM 曲马多盐酸盐 50 mg 历史美国品牌标签（Janssen；NDA 020281；2023-03 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/downloadpdffile.cfm?setId=45f59e6f-1794-40a4-8f8b-3a9415924468", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_pdf", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, { "id": "src_defef78920be450d", "label": "DailyMed（NLM）：曲马多盐酸盐 50 mg 当前美国通用药标签（Amneal；SPL v4，2026-05-21 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8ec4e4e5-a56e-4198-8428-6b770b9bf27d", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, { "id": "src_d459573b676f174f", "label": "FDA：ULTRAM NDA 020281 撤回及通用药参比标签审评记录（2024）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2024/208708Orig1s016.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "regulatory_review", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_pdf", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" } ], "applicationNumber": "FDA NDA 020281（ULTRAM，已撤回）／ANDA 076003（当前通用药比较项）", "approvalTimeline": [ { "date": "1995", "title": { "zh": "ULTRAM 美国初始批准", "en": "Initial U.S. approval of ULTRAM" }, "detail": { "zh": "历史品牌标签列出 Initial U.S. Approval: 1995，并与 50 mg 产品身份相连。", "en": "The historical brand label states Initial U.S. Approval: 1995 and links it to the 50 mg product identity." }, "source": { "id": "src_b4e1e8bd42b55fe9", "label": "DailyMed（NLM）：ULTRAM 曲马多盐酸盐 50 mg 历史美国品牌标签（Janssen；NDA 020281；2023-03 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/downloadpdffile.cfm?setId=45f59e6f-1794-40a4-8f8b-3a9415924468", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_pdf", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" } }, { "date": "2022-09-30", "title": { "zh": "历史品牌营销终止", "en": "Historical brand marketing ended" }, "detail": { "zh": "DailyMed 历史产品表列 NDC 50458-659-60 的营销终止日；不据此推断个人应停药或当前通用药状态。", "en": "The historical DailyMed product table gives the marketing end date for NDC 50458-659-60; this does not direct an individual to stop or establish current generic status." }, "source": { "id": "src_b4e1e8bd42b55fe9", "label": "DailyMed（NLM）：ULTRAM 曲马多盐酸盐 50 mg 历史美国品牌标签（Janssen；NDA 020281；2023-03 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/downloadpdffile.cfm?setId=45f59e6f-1794-40a4-8f8b-3a9415924468", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_pdf", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" } }, { "date": "2023-10-05", "title": { "zh": "NDA 020281 撤回生效", "en": "Withdrawal of NDA 020281 became effective" }, "detail": { "zh": "FDA 审评记录注明该产品不是因安全性或有效性原因撤市，并把当前标签承接问题与通用药参比记录分开讨论。", "en": "The FDA review states the product was not withdrawn for safety or effectiveness reasons and separately discusses current model labelling through generic-reference records." }, "source": { "id": "src_d459573b676f174f", "label": "FDA：ULTRAM NDA 020281 撤回及通用药参比标签审评记录（2024）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2024/208708Orig1s016.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "regulatory_review", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_pdf", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" } }, { "date": "2026-05-21", "title": { "zh": "当前通用药标签发布", "en": "Current generic label published" }, "detail": { "zh": "Amneal SPL v4 提供当前警示、Medication Guide、50 mg 产品和准确 100 片瓶装面板。", "en": "Amneal SPL v4 provides current warnings, a Medication Guide, the 50 mg product and an exact 100-tablet bottle panel." }, "source": { "id": "src_defef78920be450d", "label": "DailyMed（NLM）：曲马多盐酸盐 50 mg 当前美国通用药标签（Amneal；SPL v4，2026-05-21 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8ec4e4e5-a56e-4198-8428-6b770b9bf27d", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "历史品牌已停止；当前通用药比较项已建立", "en": "Historical brand ended; current generic comparator established" }, "detail": { "zh": "品牌、通用药、NDA、ANDA、NDC 和包装必须分别核对。", "en": "Brand, generic, NDA, ANDA, NDC and package must be checked separately." } }, { "market": { "zh": "中国大陆及其他市场", "en": "Mainland China and other markets" }, "status": { "zh": "现行监管记录待逐项建立", "en": "Current regulatory records not yet established" }, "detail": { "zh": "不从美国历史品牌或通用药包装推定当地批准、供应、原研／仿制关系或合法购药渠道。", "en": "No local approval, supply, originator/generic relationship or lawful purchasing route is inferred from a historical U.S. brand or generic pack." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "有刻痕就可以掰半吗？", "en": "Does a score mean I can split it in half?" }, "answer": { "zh": "不能只凭刻痕这样决定。刻痕是产品身份线索；是否可分、分后是否符合处方及能否安全操作，需要核对手中准确产品、当前说明书和专业意见。网页不把 50 mg 自动换成个人的两份 25 mg 用法。", "en": "Not from the score alone. It is a product-identity clue. Whether splitting is permitted, matches the prescription and can be done safely requires the exact product, current label and professional review. The site does not turn 50 mg into two personal 25 mg instructions." } }, { "question": { "zh": "曲马多和安眠药错开吃就安全吗？", "en": "Is tramadol safe with a sleeping medicine if times are separated?" }, "answer": { "zh": "网页不能确认。两类药的镇静和呼吸抑制作用可能重叠，错开时间本身不证明安全；应把完整药单、酒精使用和实际服用时间交给医生或药师核对。", "en": "A webpage cannot confirm that. Sedation and respiratory-depression effects may overlap, and separate timing does not prove safety. Have a clinician or pharmacist review the complete list, alcohol exposure and actual timing." } }, { "question": { "zh": "要不要先做 CYP2D6 基因检测？", "en": "Should CYP2D6 testing be done first?" }, "answer": { "zh": "不是人人都能从全基因或单基因筛查得到可直接执行的选药答案。是否检测取决于具体临床问题、既往反应、完整药单及可用解释路径，应由专业人员判断；出现严重不适先处理急症，不等待基因结果。", "en": "Not everyone obtains an actionable medicine-selection answer from whole-genome or single-gene screening. Testing depends on the clinical question, prior response, full medicine list and an available interpretation pathway. Severe symptoms require urgent care rather than waiting for a genetic result." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "polypharmacy-safety-guide", "dosage-forms-are-part-of-medicine-identity", "pharmacogenomics-drug-response" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/ultram/", "en": "https://origindrug.com/en/drugs/ultram/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "janumet-xr", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-30", "status": "published_traceable_archive" }, "names": { "brand": "JANUMET XR", "generic": "西格列汀/盐酸二甲双胍缓释片", "aliases": [ "Janumet XR", "sitagliptin and metformin hydrochloride extended-release", "sitagliptin metformin XR", "西格列汀二甲双胍缓释片", "西格列汀/盐酸二甲双胍缓释片", "捷诺达 XR", "NDA 202270", "0006-0078-61", "0006-0080-61", "0006-0081-31", "JANUMET XR 78", "JANUMET XR 80", "JANUMET XR 81" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "代谢", "sourceArchiveMarket": "美国 JANUMET XR 有日期公开品牌标签（DailyMed SPL v43，2025-03-25 生效；NDA 202270）。本页精确展示三种标签主面板：50 mg/500 mg、NDC 0006-0078-61、60 片；50 mg/1,000 mg、NDC 0006-0080-61、60 片；100 mg/1,000 mg、NDC 0006-0081-31、30 片。欧盟 JANUMET 当前资料为普通片，不能据此替代美国 XR 缓释产品。", "dosageFormClass": "西格列汀/盐酸二甲双胍薄膜衣缓释片：100/1,000 mg、50/500 mg、50/1,000 mg（美国公开标签）", "dosageFormClassCode": "oral_modified_release", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "2012（当前美国标签所列初始批准）", "archiveSponsorText": "Merck Sharp & Dohme LLC / DailyMed（NLM）美国公开品牌标签" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [ "JANUMET XR", "Janumet XR", "西格列汀二甲双胍缓释片" ], "excludedProductCues": [ "JANUMET immediate-release", "JANUMET tablets", "JANUVIA", "sitagliptin tablet", "GLUCOPHAGE", "metformin tablet", "JUVISYNC", "STEGLUJAN", "RYBELSUS" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-janumet-xr-sitagliptin-50mg-metformin-500mg-0006007861", "marketCode": "US", "labelVersion": { "zh": "DailyMed 美国公开标签 SPL v43（2025-03-25 生效）；准确展示包装，不代表实时供应", "en": "U.S. DailyMed public label SPL v43 (effective 25 Mar 2025); exact displayed pack, not real-time availability" }, "dosageForm": { "zh": "JANUMET XR 西格列汀/盐酸二甲双胍薄膜衣缓释片", "en": "JANUMET XR sitagliptin/metformin hydrochloride film-coated extended-release tablet" }, "route": { "zh": "口服；缓释片应整片吞服", "en": "oral; extended-release tablet is swallowed whole" }, "routeCodes": [ "oral" ], "productCode": "NDC 0006-0078-61", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片西格列汀 50 mg + 盐酸二甲双胍 500 mg；60 片瓶装", "en": "50 mg sitagliptin + 500 mg metformin HCl per tablet; 60-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=janumetxr-05.jpg&setid=64beb3d2-3aeb-4cd5-ba11-dacf6c9a5b50", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "西格列汀", "en": "sitagliptin" }, "value": 50, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片第一种活性成分标示量；不是个人片数或换算指令", "en": "labelled amount of the first active ingredient per tablet; not an individual tablet count or conversion instruction" } }, { "ingredient": { "zh": "盐酸二甲双胍缓释成分", "en": "metformin hydrochloride extended-release component" }, "value": 500, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片第二种活性成分标示量；不是个人片数或换算指令", "en": "labelled amount of the second active ingredient per tablet; not an individual tablet count or conversion instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "塑料瓶", "en": "plastic bottle" }, "fill": null, "countPerPackage": 60, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": null, "package": { "count": 60, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "浅蓝色", "en": "light blue" }, "shape": { "zh": "椭圆形、双凸、无刻痕薄膜衣片", "en": "oval, biconvex, unscored film-coated tablet" }, "imprint": "78", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_197ea8a69635a89a", "label": "DailyMed（NLM）：JANUMET XR 50 mg/500 mg、NDC 0006-0078-61、60 片瓶装美国标签面板", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=64beb3d2-3aeb-4cd5-ba11-dacf6c9a5b50", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-janumet-xr-sitagliptin-50mg-metformin-1000mg-0006008061", "marketCode": "US", "labelVersion": { "zh": "DailyMed 美国公开标签 SPL v43（2025-03-25 生效）；准确展示包装，不代表实时供应", "en": "U.S. DailyMed public label SPL v43 (effective 25 Mar 2025); exact displayed pack, not real-time availability" }, "dosageForm": { "zh": "JANUMET XR 西格列汀/盐酸二甲双胍薄膜衣缓释片", "en": "JANUMET XR sitagliptin/metformin hydrochloride film-coated extended-release tablet" }, "route": { "zh": "口服；缓释片应整片吞服", "en": "oral; extended-release tablet is swallowed whole" }, "routeCodes": [ "oral" ], "productCode": "NDC 0006-0080-61", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片西格列汀 50 mg + 盐酸二甲双胍 1,000 mg；60 片瓶装", "en": "50 mg sitagliptin + 1,000 mg metformin HCl per tablet; 60-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=janumetxr-06.jpg&setid=64beb3d2-3aeb-4cd5-ba11-dacf6c9a5b50", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "西格列汀", "en": "sitagliptin" }, "value": 50, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片第一种活性成分标示量；不是个人片数或换算指令", "en": "labelled amount of the first active ingredient per tablet; not an individual tablet count or conversion instruction" } }, { "ingredient": { "zh": "盐酸二甲双胍缓释成分", "en": "metformin hydrochloride extended-release component" }, "value": 1000, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片第二种活性成分标示量；不是个人片数或换算指令", "en": "labelled amount of the second active ingredient per tablet; not an individual tablet count or conversion instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "塑料瓶", "en": "plastic bottle" }, "fill": null, "countPerPackage": 60, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": null, "package": { "count": 60, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "浅绿色", "en": "light green" }, "shape": { "zh": "椭圆形、双凸、无刻痕薄膜衣片", "en": "oval, biconvex, unscored film-coated tablet" }, "imprint": "80", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_197ea8a69635a89a", "label": "DailyMed（NLM）：JANUMET XR 50 mg/1,000 mg、NDC 0006-0080-61、60 片瓶装美国标签面板", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=64beb3d2-3aeb-4cd5-ba11-dacf6c9a5b50", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-janumet-xr-sitagliptin-100mg-metformin-1000mg-0006008131", "marketCode": "US", "labelVersion": { "zh": "DailyMed 美国公开标签 SPL v43（2025-03-25 生效）；准确展示包装，不代表实时供应", "en": "U.S. DailyMed public label SPL v43 (effective 25 Mar 2025); exact displayed pack, not real-time availability" }, "dosageForm": { "zh": "JANUMET XR 西格列汀/盐酸二甲双胍薄膜衣缓释片", "en": "JANUMET XR sitagliptin/metformin hydrochloride film-coated extended-release tablet" }, "route": { "zh": "口服；缓释片应整片吞服", "en": "oral; extended-release tablet is swallowed whole" }, "routeCodes": [ "oral" ], "productCode": "NDC 0006-0081-31", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片西格列汀 100 mg + 盐酸二甲双胍 1,000 mg；30 片瓶装", "en": "100 mg sitagliptin + 1,000 mg metformin HCl per tablet; 30-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=janumetxr-07.jpg&setid=64beb3d2-3aeb-4cd5-ba11-dacf6c9a5b50", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "西格列汀", "en": "sitagliptin" }, "value": 100, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片第一种活性成分标示量；不是个人片数或换算指令", "en": "labelled amount of the first active ingredient per tablet; not an individual tablet count or conversion instruction" } }, { "ingredient": { "zh": "盐酸二甲双胍缓释成分", "en": "metformin hydrochloride extended-release component" }, "value": 1000, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片第二种活性成分标示量；不是个人片数或换算指令", "en": "labelled amount of the second active ingredient per tablet; not an individual tablet count or conversion instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "塑料瓶", "en": "plastic bottle" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": null, "package": { "count": 30, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "蓝色", "en": "blue" }, "shape": { "zh": "椭圆形、双凸、无刻痕薄膜衣片", "en": "oval, biconvex, unscored film-coated tablet" }, "imprint": "81", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_197ea8a69635a89a", "label": "DailyMed（NLM）：JANUMET XR 100 mg/1,000 mg、NDC 0006-0081-31、30 片瓶装美国标签面板", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=64beb3d2-3aeb-4cd5-ba11-dacf6c9a5b50", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-janumet-xr-sitagliptin-100mg-metformin-1000mg-0006008131", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=janumetxr-07.jpg&setid=64beb3d2-3aeb-4cd5-ba11-dacf6c9a5b50", "alt": "JANUMET XR 西格列汀 100 mg/盐酸二甲双胍 1,000 mg、NDC 0006-0081-31、30 片瓶装的美国 DailyMed 标签展示面", "archiveMarket": "美国", "labelVersion": "DailyMed SPL v43；2025-03-25 生效", "presentation": "JANUMET XR 每片西格列汀 100 mg/盐酸二甲双胍 1,000 mg，NDC 0006-0081-31，30 片瓶装标签展示面。", "notice": "此图只对应所引美国标签中的 100 mg/1,000 mg、NDC 0006-0081-31、30 片瓶装；不代表另两张展示面、同强度其他瓶装 NDC、JANUMET 普通片、其他市场包装或当前可得性，不用于鉴定真伪，也不生成个人片数。", "source": { "id": "src_197ea8a69635a89a", "label": "DailyMed（NLM）：JANUMET XR 100 mg/1,000 mg、NDC 0006-0081-31、30 片瓶装美国标签面板", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=64beb3d2-3aeb-4cd5-ba11-dacf6c9a5b50", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "JANUMET XR 说明书放大阅读：一片两种成分，XR 缓释片不得掰开、切开、压碎或咀嚼", "en": "JANUMET XR label reading: two ingredients in one tablet; do not break, cut, crush or chew the XR tablet" }, "summary": { "zh": "美国标签列三种强度。先确认准确 NDC 和两个成分数字，不要相加、按外观估算后掰片，或再自行加用 JANUVIA、西格列汀、GLUCOPHAGE 或二甲双胍产品。", "en": "The U.S. label lists three strengths. Confirm the exact NDC and both ingredient figures; do not add the numbers, estimate and split from appearance, or self-add JANUVIA/sitagliptin, GLUCOPHAGE or metformin products." }, "checks": [ { "zh": "例如“50 mg/1,000 mg”表示每片含西格列汀 50 mg 和盐酸二甲双胍 1,000 mg；它不是 1,050 mg 的可比强度，也不是两个服用时间。", "en": "For example, 50 mg/1,000 mg means 50 mg sitagliptin and 1,000 mg metformin HCl per tablet. It is not a comparable 1,050 mg strength or two times of day." }, { "zh": "标签要求整片吞服，并明确不得掰开、切开、压碎或咀嚼。网页只解释标签文字，不根据这一句替任何人选择时间、频次、片数或替代剂型。", "en": "The label requires swallowing whole and says not to break, cut, crush or chew. The site explains that text only; it does not select an individual's time, frequency, tablet count or alternative dosage form." }, { "zh": "黑框警示涉及二甲双胍相关乳酸性酸中毒，标签还要求核对肾功能、脱水、饮酒、手术和含碘造影；65 岁及以上、多病或多药使用者尤其应带完整药单和检查安排核对。", "en": "The boxed warning covers metformin-associated lactic acidosis, and the label also requires review of kidney function, dehydration, alcohol, surgery and iodinated contrast. People aged 65 or older and those with several conditions or medicines should especially bring the full medicine list and planned investigations for review." }, { "zh": "严重虚弱、呼吸困难、持续呕吐、明显意识变化、严重腹痛或其他急性重症需要立即使用当地急救渠道并带上全部药盒；不要等待网页判断是否停药或补服。", "en": "Severe weakness, breathing difficulty, persistent vomiting, marked altered awareness, severe abdominal pain or another acute serious concern requires local emergency help with every medicine pack. Do not wait for a webpage to decide interruption or make-up use." } ], "source": { "id": "src_197ea8a69635a89a", "label": "DailyMed（NLM）：JANUMET XR 美国公开标签与 Medication Guide（SPL v43）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=64beb3d2-3aeb-4cd5-ba11-dacf6c9a5b50", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "两种成分怎样配合：西格列汀减慢肠促胰岛素失活，二甲双胍影响肝糖生成与胰岛素敏感性", "en": "How the ingredients work: sitagliptin slows incretin inactivation, while metformin affects hepatic glucose production and insulin sensitivity" }, "summary": { "zh": "标签把西格列汀列为 DPP-4 抑制剂，把二甲双胍列为双胍类。两条作用路径解释固定复方的组成，但不能推导个人该选哪种强度、是否适合、何时停用或是否应与其他降糖药联合。", "en": "The label identifies sitagliptin as a DPP-4 inhibitor and metformin as a biguanide. The two pathways explain the fixed combination but cannot determine an individual's strength, suitability, interruption or combination with another glucose-lowering medicine." }, "checks": [ { "zh": "“两种机制互补”不是把 JANUVIA 和二甲双胍自行拼成 JANUMET XR 的许可；缓释结构、成分量、标签和监测边界属于准确产品。", "en": "“Complementary mechanisms” do not permit self-assembling JANUMET XR from JANUVIA and metformin. The extended-release structure, ingredient amounts, label and monitoring boundaries belong to the exact product." }, { "zh": "共同写有西格列汀或二甲双胍，不表示 JANUMET、JANUMET XR、单方药和其他复方可以按毫克数自行叠加、轮换或替换。剂型、释放方式、肾功能和完整药单必须一起核对。", "en": "A shared sitagliptin or metformin name does not make JANUMET, JANUMET XR, single-ingredient products and other combinations self-combinable, alternatable or substitutable by milligrams. Dosage form, release design, kidney function and the complete medicine list require joint review." }, { "zh": "基因筛查不是网页替个人选择这款药的默认答案。个体适用性要结合诊断、肾功能、完整药单、既往反应和目标市场现行说明书，由负责团队判断。", "en": "Genetic screening is not the site's default answer for choosing this medicine. Individual suitability requires diagnosis, kidney function, the complete medicine list, prior response and the current target-market label, reviewed by the treating team." } ], "source": { "id": "src_197ea8a69635a89a", "label": "DailyMed（NLM）：JANUMET XR 美国公开标签（12.1 Mechanism of Action）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=64beb3d2-3aeb-4cd5-ba11-dacf6c9a5b50", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "JANUMET XR", "generic": "西格列汀/盐酸二甲双胍缓释片", "dosageFormClass": "西格列汀/盐酸二甲双胍薄膜衣缓释片：100/1,000 mg、50/500 mg、50/1,000 mg（美国公开标签）" }, "labelSource": { "id": "src_197ea8a69635a89a", "label": "DailyMed（NLM）：JANUMET XR 美国公开品牌标签、三种展示包装与 Medication Guide（SPL v43）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=64beb3d2-3aeb-4cd5-ba11-dacf6c9a5b50", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "productRoutes": [ { "source": { "id": "src_197ea8a69635a89a", "label": "DailyMed（NLM）：JANUMET XR 美国公开品牌标签、三种展示包装与 Medication Guide（SPL v43）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=64beb3d2-3aeb-4cd5-ba11-dacf6c9a5b50", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-30", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_e37da60287b46c9e", "label": "EMA：JANUMET 欧盟集中许可产品页（普通片；与美国 XR 分开）", "url": "https://www.ema.europa.eu/en/medicines/human/EPAR/janumet", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "status": "product_level_public_record_verified", "authority": { "zh": "EMA", "en": "EMA" }, "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "recordType": { "zh": "监管产品记录或欧盟产品资料", "en": "Regulatory product record or EU product information" }, "reviewedAt": "2026-08-30", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-30", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "JANUMET XR 一片同时含西格列汀和盐酸二甲双胍缓释成分。包装上的两个 mg 数字分别属于两种成分，不能相加成一个总强度，也不能与 JANUVIA、GLUCOPHAGE、JANUMET 普通片或其他含共同成分的降糖药自行拼接。当前美国标签列三种强度，并要求缓释片整片吞服，不得掰开、切开、压碎或咀嚼。网页帮助认清准确产品、成分、每片标示量和官方说明书，不生成个人片数、频次、联用、换药、补服或停药方案。", "history": "当前 DailyMed 标签列 JANUMET XR 美国初始批准年份为 2012，并把产品与 NDA 202270 相连。JANUMET 普通片、JANUMET XR 缓释片和欧盟 JANUMET 普通片具有不同的剂型、规格或市场文件；共同品牌词根和共同成分不能建立自行互换关系。", "sourceDocuments": [ { "id": "src_197ea8a69635a89a", "label": "DailyMed（NLM）：JANUMET XR 美国公开品牌标签、三种展示包装与 Medication Guide（SPL v43）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=64beb3d2-3aeb-4cd5-ba11-dacf6c9a5b50", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, { "id": "src_5ed30b676fbb9773", "label": "FDA Drugs@FDA：JANUMET XR NDA 202270 官方检索入口", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_lookup_entry", "documentKind": "regulatory_lookup", "market": "US", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_e37da60287b46c9e", "label": "EMA：JANUMET 欧盟集中许可产品页（普通片；与美国 XR 分开）", "url": "https://www.ema.europa.eu/en/medicines/human/EPAR/janumet", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" } ], "applicationNumber": "FDA NDA 202270（JANUMET XR；西格列汀/盐酸二甲双胍缓释片）", "approvalTimeline": [ { "date": "2012-02-02", "title": { "zh": "美国 JANUMET XR NDA 202270 产品营销记录起始", "en": "U.S. JANUMET XR NDA 202270 product marketing record began" }, "detail": { "zh": "DailyMed 产品数据把 JANUMET XR、NDA 202270 和 2012-02-02 营销起始记录相连；标签同时列美国初始批准年份为 2012。该节点只建立美国产品史。", "en": "DailyMed product data link JANUMET XR, NDA 202270 and a 2 Feb 2012 marketing-start record; the label also lists 2012 as the initial U.S. approval year. This establishes U.S. product history only." }, "source": { "id": "src_197ea8a69635a89a", "label": "DailyMed（NLM）：JANUMET XR 美国公开标签（NDA 202270 产品记录）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=64beb3d2-3aeb-4cd5-ba11-dacf6c9a5b50", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" } }, { "date": "2025-03-25", "title": { "zh": "DailyMed SPL v43 标签生效", "en": "DailyMed SPL v43 label effective" }, "detail": { "zh": "本页准确包装、缓释片整片吞服、两种成分、肾功能、含碘造影与乳酸性酸中毒等阅读边界均以该标签为主要来源。", "en": "This page uses that label as the primary source for exact packages, whole-tablet handling, both ingredients, kidney function, iodinated contrast and lactic-acidosis reading boundaries." }, "source": { "id": "src_197ea8a69635a89a", "label": "DailyMed（NLM）：JANUMET XR SPL v43 美国公开品牌标签（2025-03-25 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=64beb3d2-3aeb-4cd5-ba11-dacf6c9a5b50", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "有日期公开品牌标签与三种准确主展示包装已建立", "en": "Dated public brand label and three exact principal-display packages established" }, "detail": { "zh": "逐一记录每片双成分量、NDC、瓶装数量、颜色、形状、刻印和官方标签面板；不表示具体渠道库存、购买资格、真伪或个人片数。", "en": "Records both per-tablet ingredient amounts, NDC, bottle count, colour, shape, imprint and official label panel. It does not establish channel stock, purchasing eligibility, authenticity or an individual tablet count." } }, { "market": { "zh": "欧盟", "en": "European Union" }, "status": { "zh": "JANUMET 普通片资料作为分市场核对入口", "en": "JANUMET immediate-release material retained as a separate-market check" }, "detail": { "zh": "EMA 当前 JANUMET 产品资料列 50 mg/850 mg 与 50 mg/1,000 mg 普通片。它不是美国 JANUMET XR 缓释片的包装、规格或替换表。", "en": "Current EMA JANUMET product information lists 50 mg/850 mg and 50 mg/1,000 mg immediate-release tablets. It is not a package, strength or substitution table for U.S. JANUMET XR extended-release tablets." } }, { "market": { "zh": "中国大陆、日本及其他市场", "en": "Mainland China, Japan and other markets" }, "status": { "zh": "待逐项建立现行监管产品记录", "en": "Current regulatory product records not established" }, "detail": { "zh": "不从美国或欧盟商品名、共同成分、NDA/许可或包装推定当地批准、持有人、规格、供应、原研/参比关系或可替代性。", "en": "No local approval, holder, strength, supply, originator/reference relationship or interchangeability is inferred from a U.S. or EU trade name, shared ingredients, NDA/authorisation or pack." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "50 mg/1,000 mg 是 1,050 mg，还是两个时间？", "en": "Does 50 mg/1,000 mg mean 1,050 mg, or two times of day?" }, "answer": { "zh": "都不是。它表示一片分别含西格列汀 50 mg 和盐酸二甲双胍 1,000 mg。两个数字属于两种成分，不能相加后与其他药比较，也不能推导个人频次或片数。", "en": "Neither. One tablet contains 50 mg sitagliptin and 1,000 mg metformin HCl. The two numbers belong to two ingredients and cannot be added for comparison with another medicine or used to derive an individual's frequency or tablet count." } }, { "question": { "zh": "药片太大，可以掰半、切开或压碎吗？", "en": "Can a large tablet be halved, cut or crushed?" }, "answer": { "zh": "当前美国标签要求整片吞服，并明确不得掰开、切开、压碎或咀嚼。吞咽困难时请带准确药盒联系开方团队或药师讨论其他可行产品，不要自行破坏缓释结构。", "en": "The current U.S. label requires swallowing whole and explicitly says not to break, cut, crush or chew. If swallowing is difficult, take the exact pack to the prescriber or pharmacist to discuss another appropriate product rather than damaging the extended-release design." } }, { "question": { "zh": "说明书写到有的人使用两片，是不是所有人都能照着吃两片？", "en": "The label mentions two tablets for some people; can everyone follow that?" }, "answer": { "zh": "不能。标签同时明确方案必须根据既往用药、效果、耐受和肾功能个体化。网页只解释为什么瓶装片数和每片强度不能直接变成个人吃法；实际片数必须以本人处方和负责团队核对为准。", "en": "No. The label also states that the regimen is individualised from prior treatment, effectiveness, tolerability and kidney function. The site only explains why bottle count and per-tablet strength cannot become a personal regimen; actual tablet count must follow the individual's prescription and treating-team review." } }, { "question": { "zh": "已经使用 JANUMET XR，还能再用 JANUVIA 或二甲双胍吗？", "en": "Can JANUVIA or metformin be added when JANUMET XR is already used?" }, "answer": { "zh": "网页不能决定联用。JANUMET XR 已含西格列汀和盐酸二甲双胍；药单中再出现共同成分必须优先核对，不能自行叠加、轮换或停掉其中一盒。", "en": "A webpage cannot decide combination use. JANUMET XR already contains sitagliptin and metformin HCl. Another shared ingredient on the medicine list requires priority review, not self-combination, alternation or stopping a pack." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "dosage-forms-are-part-of-medicine-identity", "how-to-read-a-drug-label", "generic-drugs-and-bioequivalence" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/janumet-xr/", "en": "https://origindrug.com/en/drugs/janumet-xr/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "jentadueto-xr", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-30", "status": "published_traceable_archive" }, "names": { "brand": "JENTADUETO XR", "generic": "利格列汀/盐酸二甲双胍缓释片", "aliases": [ "Jentadueto XR", "linagliptin and metformin hydrochloride extended-release", "linagliptin metformin XR", "利格列汀二甲双胍缓释片", "利格列汀/盐酸二甲双胍缓释片", "NDA 208026", "0597-0270-73", "0597-0275-33", "BI D2 1000 M", "BI D5 1000 M" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "代谢", "sourceArchiveMarket": "美国 JENTADUETO XR 当前公开品牌标签（DailyMed SPL v10，2026-08-19 更新、2026-08-27 发布；NDA 208026）。本页精确展示两种标签主面板：2.5 mg/1,000 mg、NDC 0597-0270-73、60 片；5 mg/1,000 mg、NDC 0597-0275-33、30 片。标签另列 180 片与 90 片瓶装，但没有将其包装数量或 NDC 改写成实时供应。", "dosageFormClass": "利格列汀/盐酸二甲双胍薄膜衣缓释片：2.5/1,000 mg、5/1,000 mg（美国当前公开标签）", "dosageFormClassCode": "oral_modified_release", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "2016-05-27（FDA NDA 208026 原始批准）", "archiveSponsorText": "Boehringer Ingelheim Pharmaceuticals, Inc. / DailyMed（NLM）与 FDA 美国公开资料" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [ "JENTADUETO XR", "Jentadueto XR", "利格列汀二甲双胍缓释片" ], "excludedProductCues": [ "JENTADUETO immediate-release", "JENTADUETO tablets", "TRADJENTA", "linagliptin tablet", "GLUCOPHAGE", "metformin tablet", "TRIJARDY XR", "GLYXAMBI" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-jentadueto-xr-linagliptin-2-5mg-metformin-1000mg-0597027073", "marketCode": "US", "labelVersion": { "zh": "DailyMed 美国当前公开标签 SPL v10（2026-08-19 更新，2026-08-27 发布）；准确展示包装，不代表实时供应", "en": "Current U.S. DailyMed public label SPL v10 (updated 19 Aug and published 27 Aug 2026); exact displayed pack, not real-time availability" }, "dosageForm": { "zh": "JENTADUETO XR 利格列汀/盐酸二甲双胍薄膜衣缓释片", "en": "JENTADUETO XR linagliptin/metformin hydrochloride film-coated extended-release tablet" }, "route": { "zh": "口服；缓释片应整片吞服", "en": "oral; extended-release tablet is swallowed whole" }, "routeCodes": [ "oral" ], "productCode": "NDC 0597-0270-73", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片利格列汀 2.5 mg + 盐酸二甲双胍 1,000 mg；60 片瓶装", "en": "2.5 mg linagliptin + 1,000 mg metformin HCl per tablet; 60-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=jentadueto-07.jpg&setid=3d02a4d4-d312-80b4-05c4-691b8f0aa7aa&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "利格列汀", "en": "linagliptin" }, "value": 2.5, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片第一种活性成分标示量；不是个人片数或换算指令", "en": "labelled amount of the first active ingredient per tablet; not an individual tablet count or conversion instruction" } }, { "ingredient": { "zh": "盐酸二甲双胍缓释成分", "en": "metformin hydrochloride extended-release component" }, "value": 1000, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片第二种活性成分标示量；不是个人片数或换算指令", "en": "labelled amount of the second active ingredient per tablet; not an individual tablet count or conversion instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "塑料瓶", "en": "plastic bottle" }, "fill": null, "countPerPackage": 60, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": null, "package": { "count": 60, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "黄色", "en": "yellow" }, "shape": { "zh": "椭圆形、薄膜衣片", "en": "oval, film-coated tablet" }, "imprint": "BI symbol / D2 / 1000 M", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_8d14f3da071761ee", "label": "DailyMed（NLM）：JENTADUETO XR 2.5 mg/1,000 mg、NDC 0597-0270-73、60 片瓶装美国标签面板", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=3d02a4d4-d312-80b4-05c4-691b8f0aa7aa", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-jentadueto-xr-linagliptin-5mg-metformin-1000mg-0597027533", "marketCode": "US", "labelVersion": { "zh": "DailyMed 美国当前公开标签 SPL v10（2026-08-19 更新，2026-08-27 发布）；准确展示包装，不代表实时供应", "en": "Current U.S. DailyMed public label SPL v10 (updated 19 Aug and published 27 Aug 2026); exact displayed pack, not real-time availability" }, "dosageForm": { "zh": "JENTADUETO XR 利格列汀/盐酸二甲双胍薄膜衣缓释片", "en": "JENTADUETO XR linagliptin/metformin hydrochloride film-coated extended-release tablet" }, "route": { "zh": "口服；缓释片应整片吞服", "en": "oral; extended-release tablet is swallowed whole" }, "routeCodes": [ "oral" ], "productCode": "NDC 0597-0275-33", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片利格列汀 5 mg + 盐酸二甲双胍 1,000 mg；30 片瓶装", "en": "5 mg linagliptin + 1,000 mg metformin HCl per tablet; 30-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=jentadueto-08.jpg&setid=3d02a4d4-d312-80b4-05c4-691b8f0aa7aa&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "利格列汀", "en": "linagliptin" }, "value": 5, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片第一种活性成分标示量；不是个人片数或换算指令", "en": "labelled amount of the first active ingredient per tablet; not an individual tablet count or conversion instruction" } }, { "ingredient": { "zh": "盐酸二甲双胍缓释成分", "en": "metformin hydrochloride extended-release component" }, "value": 1000, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片第二种活性成分标示量；不是个人片数或换算指令", "en": "labelled amount of the second active ingredient per tablet; not an individual tablet count or conversion instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "塑料瓶", "en": "plastic bottle" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": null, "package": { "count": 30, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "白色", "en": "white" }, "shape": { "zh": "椭圆形、薄膜衣片", "en": "oval, film-coated tablet" }, "imprint": "BI symbol / D5 / 1000 M", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_8d14f3da071761ee", "label": "DailyMed（NLM）：JENTADUETO XR 5 mg/1,000 mg、NDC 0597-0275-33、30 片瓶装美国标签面板", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=3d02a4d4-d312-80b4-05c4-691b8f0aa7aa", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-jentadueto-xr-linagliptin-2-5mg-metformin-1000mg-0597027073", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=jentadueto-07.jpg&setid=3d02a4d4-d312-80b4-05c4-691b8f0aa7aa&type=img", "alt": "JENTADUETO XR 利格列汀 2.5 mg/盐酸二甲双胍 1,000 mg、NDC 0597-0270-73、60 片瓶装的美国 DailyMed 标签展示面", "archiveMarket": "美国", "labelVersion": "DailyMed SPL v10；2026-08-19 更新，2026-08-27 发布", "presentation": "JENTADUETO XR 每片利格列汀 2.5 mg/盐酸二甲双胍 1,000 mg，NDC 0597-0270-73，60 片瓶装标签展示面。", "notice": "此图只对应当前美国标签中的 2.5 mg/1,000 mg、NDC 0597-0270-73、60 片瓶装；不代表 180 片瓶装、5 mg/1,000 mg、JENTADUETO 普通片、TRADJENTA、其他市场包装或当前可得性，不用于鉴定真伪，也不生成个人片数。", "source": { "id": "src_8d14f3da071761ee", "label": "DailyMed（NLM）：JENTADUETO XR 2.5 mg/1,000 mg、NDC 0597-0270-73、60 片瓶装美国标签面板", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=3d02a4d4-d312-80b4-05c4-691b8f0aa7aa", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "JENTADUETO XR 说明书放大阅读：一片两种成分，XR 缓释片不得掰开、压碎、溶解或咀嚼", "en": "JENTADUETO XR label reading: two ingredients in one tablet; do not split, crush, dissolve or chew the XR tablet" }, "summary": { "zh": "美国标签列两种强度。先确认准确 NDC 和两个成分数字，不要相加、按外观估算后掰片，或再自行加用 TRADJENTA、利格列汀、GLUCOPHAGE 或二甲双胍产品。", "en": "The U.S. label lists two strengths. Confirm the exact NDC and both ingredient figures; do not add the numbers, estimate and split from appearance, or self-add TRADJENTA/linagliptin, GLUCOPHAGE or metformin products." }, "checks": [ { "zh": "例如“2.5 mg/1,000 mg”表示每片含利格列汀 2.5 mg 和盐酸二甲双胍 1,000 mg；它不是 1,002.5 mg 的可比强度，也不是两个服用时间。", "en": "For example, 2.5 mg/1,000 mg means 2.5 mg linagliptin and 1,000 mg metformin HCl per tablet. It is not a comparable 1,002.5 mg strength or two times of day." }, { "zh": "标签要求整片吞服，并明确不得掰开、压碎、溶解或咀嚼。网页不根据标签中的专业方案替任何人选择频次、片数或转换方法。", "en": "The label requires swallowing whole and says not to split, crush, dissolve or chew. The site does not use clinician-facing regimens in the label to choose an individual's frequency, tablet count or transition method." }, { "zh": "黑框警示涉及二甲双胍相关乳酸性酸中毒；肾功能、65 岁及以上、含碘造影、手术、缺氧状态、过量饮酒和肝功能问题都是标签列出的优先核对边界。", "en": "The boxed warning covers metformin-associated lactic acidosis. Kidney function, age 65 or older, iodinated contrast, surgery, hypoxic states, excessive alcohol and hepatic impairment are label-listed priority review boundaries." }, { "zh": "严重虚弱、呼吸困难、持续呕吐、明显意识变化、严重腹痛或其他急性重症需要立即使用当地急救渠道并带上全部药盒；不要等待网页判断是否停药或补服。", "en": "Severe weakness, breathing difficulty, persistent vomiting, marked altered awareness, severe abdominal pain or another acute serious concern requires local emergency help with every medicine pack. Do not wait for a webpage to decide interruption or make-up use." } ], "source": { "id": "src_8d14f3da071761ee", "label": "DailyMed（NLM）：JENTADUETO XR 当前美国公开标签与 Medication Guide（SPL v10）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=3d02a4d4-d312-80b4-05c4-691b8f0aa7aa", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "两种成分怎样配合：利格列汀减慢肠促胰岛素失活，二甲双胍影响肝糖生成与胰岛素敏感性", "en": "How the ingredients work: linagliptin slows incretin inactivation, while metformin affects hepatic glucose production and insulin sensitivity" }, "summary": { "zh": "标签把利格列汀列为 DPP-4 抑制剂，把二甲双胍列为双胍类。标签还说明该片由二甲双胍缓释核心和利格列汀即时释放外层组成。两条作用路径和特定释放结构解释固定复方，但不能推导个人该选哪种强度、是否适合或能否与其他降糖药联合。", "en": "The label identifies linagliptin as a DPP-4 inhibitor and metformin as a biguanide. It also describes a metformin extended-release core coated with immediate-release linagliptin. These pathways and the specific release structure explain the fixed combination but cannot determine an individual's strength, suitability or combination with another glucose-lowering medicine." }, "checks": [ { "zh": "“两种机制互补”不是把 TRADJENTA 和二甲双胍自行拼成 JENTADUETO XR 的许可；缓释核心、即时释放包衣、成分量、标签和监测边界属于准确产品。", "en": "“Complementary mechanisms” do not permit self-assembling JENTADUETO XR from TRADJENTA and metformin. The extended-release core, immediate-release coating, ingredient amounts, label and monitoring boundaries belong to the exact product." }, { "zh": "共同写有利格列汀或二甲双胍，不表示 JENTADUETO、JENTADUETO XR、单方药和其他复方可以按毫克数自行叠加、轮换或替换。剂型、释放方式、肾功能和完整药单必须一起核对。", "en": "A shared linagliptin or metformin name does not make JENTADUETO, JENTADUETO XR, single-ingredient products and other combinations self-combinable, alternatable or substitutable by milligrams. Dosage form, release design, kidney function and the complete medicine list require joint review." }, { "zh": "基因筛查不是网页替个人选择这款药的默认答案。个体适用性要结合诊断、肾功能、完整药单、既往反应和目标市场现行说明书，由负责团队判断。", "en": "Genetic screening is not the site's default answer for choosing this medicine. Individual suitability requires diagnosis, kidney function, the complete medicine list, prior response and the current target-market label, reviewed by the treating team." } ], "source": { "id": "src_8d14f3da071761ee", "label": "DailyMed（NLM）：JENTADUETO XR 当前美国公开标签（产品结构与 12.1 Mechanism of Action）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=3d02a4d4-d312-80b4-05c4-691b8f0aa7aa", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "JENTADUETO XR", "generic": "利格列汀/盐酸二甲双胍缓释片", "dosageFormClass": "利格列汀/盐酸二甲双胍薄膜衣缓释片：2.5/1,000 mg、5/1,000 mg（美国当前公开标签）" }, "labelSource": { "id": "src_8d14f3da071761ee", "label": "DailyMed（NLM）：JENTADUETO XR 当前美国公开品牌标签、两种展示包装与 Medication Guide（SPL v10）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=3d02a4d4-d312-80b4-05c4-691b8f0aa7aa", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "productRoutes": [ { "source": { "id": "src_8d14f3da071761ee", "label": "DailyMed（NLM）：JENTADUETO XR 当前美国公开品牌标签、两种展示包装与 Medication Guide（SPL v10）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=3d02a4d4-d312-80b4-05c4-691b8f0aa7aa", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-30", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-30", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "JENTADUETO XR 一片同时含利格列汀和盐酸二甲双胍缓释成分。包装上的两个 mg 数字分别属于两种成分，不是相加后的总强度，也不是服用时间。它与 JENTADUETO 普通片、TRADJENTA 单方、GLUCOPHAGE 或其他含共同成分的产品不是可以按名称或毫克数自行拼接的同一盒药。当前美国标签列两种强度，并要求缓释片整片吞服，不得掰开、压碎、溶解或咀嚼。网页帮助认清准确产品、成分、每片标示量和官方说明书，不生成个人片数、频次、联用、换药、补服或停药方案。", "history": "FDA 于 2016-05-27 批准 JENTADUETO XR NDA 208026。当前标签所写 Initial U.S. Approval: 2012 是利格列汀/二甲双胍品牌组合的历史节点，不应误写成 XR 产品在 2012 年获批。FDA 公开审评还将 JENTADUETO 普通片 NDA 201281 与 JENTADUETO XR NDA 208026 分开比较；共同品牌词根和共同成分不能建立自行互换关系。", "sourceDocuments": [ { "id": "src_8d14f3da071761ee", "label": "DailyMed（NLM）：JENTADUETO XR 当前美国公开品牌标签、两种展示包装与 Medication Guide（SPL v10）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=3d02a4d4-d312-80b4-05c4-691b8f0aa7aa", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, { "id": "src_df2bf5960258fdd2", "label": "FDA：JENTADUETO XR NDA 208026 原始批准函（2016-05-27）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/208026Orig1s000ltr.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "regulatory_approval_letter", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, { "id": "src_22af408a91cd305e", "label": "FDA：JENTADUETO XR NDA 208026 临床药理审评（普通片与 XR 产品边界）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/208026Orig1s000ClinPharmR.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "regulatory_review", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, { "id": "src_5ed30b676fbb9773", "label": "FDA Drugs@FDA：JENTADUETO XR NDA 208026 官方检索入口", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_lookup_entry", "documentKind": "regulatory_lookup", "market": "US", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } ], "applicationNumber": "FDA NDA 208026（JENTADUETO XR；利格列汀/盐酸二甲双胍缓释片）", "approvalTimeline": [ { "date": "2016-05-27", "title": { "zh": "FDA 批准 JENTADUETO XR NDA 208026", "en": "FDA approved JENTADUETO XR NDA 208026" }, "detail": { "zh": "FDA 原始批准函确认两种缓释片规格获批。该节点建立美国 NDA 产品史，不等于其他市场的批准或当前供应。", "en": "The FDA original approval letter confirms approval of two extended-release tablet strengths. This establishes U.S. NDA product history, not another market's approval or current supply." }, "source": { "id": "src_df2bf5960258fdd2", "label": "FDA：JENTADUETO XR NDA 208026 原始批准函（2016-05-27）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/208026Orig1s000ltr.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "regulatory_approval_letter", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" } }, { "date": "2026-08-19", "title": { "zh": "DailyMed SPL v10 当前标签更新", "en": "Current DailyMed SPL v10 label updated" }, "detail": { "zh": "当前标签于 2026-08-27 公开发布。本页的两种展示包装、整片吞服、双成分、肾功能、含碘造影与乳酸性酸中毒等阅读边界均以该标签为主要来源。", "en": "The current label was publicly released on 27 Aug 2026. This page uses it as the primary source for the two displayed packs, whole-tablet handling, both ingredients, kidney function, iodinated contrast and lactic-acidosis reading boundaries." }, "source": { "id": "src_8d14f3da071761ee", "label": "DailyMed（NLM）：JENTADUETO XR SPL v10 当前美国公开品牌标签（2026-08-19 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=3d02a4d4-d312-80b4-05c4-691b8f0aa7aa", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "当前公开品牌标签与两种准确主展示包装已建立", "en": "Current public brand label and two exact principal-display packages established" }, "detail": { "zh": "逐一记录每片双成分量、NDC、瓶装数量、颜色、形状、刻印和官方标签面板；不表示具体渠道库存、购买资格、真伪或个人片数。", "en": "Records both per-tablet ingredient amounts, NDC, bottle count, colour, shape, imprint and official label panel. It does not establish channel stock, purchasing eligibility, authenticity or an individual tablet count." } }, { "market": { "zh": "中国大陆、欧盟、日本及其他市场", "en": "Mainland China, European Union, Japan and other markets" }, "status": { "zh": "待逐项建立现行监管产品记录", "en": "Current regulatory product records not established" }, "detail": { "zh": "不从美国商品名、共同成分、NDA 或包装推定当地批准、持有人、规格、供应、原研/参比关系或可替代性。", "en": "No local approval, holder, strength, supply, originator/reference relationship or interchangeability is inferred from the U.S. trade name, shared ingredients, NDA or pack." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "2.5 mg/1,000 mg 是 1,002.5 mg，还是两个服用时间？", "en": "Does 2.5 mg/1,000 mg mean 1,002.5 mg, or two dosing times?" }, "answer": { "zh": "都不是。它表示一片分别含利格列汀 2.5 mg 和盐酸二甲双胍 1,000 mg。两个数字属于两种成分，不能相加后与其他药比较，也不能推导个人频次或片数。", "en": "Neither. One tablet contains 2.5 mg linagliptin and 1,000 mg metformin HCl. The figures belong to two ingredients and cannot be added for comparison with another medicine or used to derive an individual's frequency or tablet count." } }, { "question": { "zh": "药片太大，可以掰半、压碎或溶在水里吗？", "en": "Can a large tablet be halved, crushed or dissolved in water?" }, "answer": { "zh": "当前美国标签要求整片吞服，并明确不得掰开、压碎、溶解或咀嚼。吞咽困难时请带准确药盒联系开方团队或药师讨论其他可行产品，不要自行破坏缓释结构。", "en": "The current U.S. label requires swallowing whole and explicitly says not to split, crush, dissolve or chew. If swallowing is difficult, take the exact pack to the prescriber or pharmacist to discuss another appropriate product rather than damaging the extended-release design." } }, { "question": { "zh": "已经使用 JENTADUETO XR，还能再用 TRADJENTA 或二甲双胍吗？", "en": "Can TRADJENTA or metformin be added when JENTADUETO XR is already used?" }, "answer": { "zh": "网页不能决定联用。JENTADUETO XR 已含利格列汀和盐酸二甲双胍；药单中再出现共同成分必须优先核对，不能自行叠加、轮换或停掉其中一盒。", "en": "A webpage cannot decide combination use. JENTADUETO XR already contains linagliptin and metformin HCl. Another shared ingredient on the medicine list requires priority review, not self-combination, alternation or stopping a pack." } }, { "question": { "zh": "JENTADUETO 普通片和 JENTADUETO XR 是一样的吗？", "en": "Are JENTADUETO immediate-release and JENTADUETO XR the same?" }, "answer": { "zh": "不是同一剂型。FDA 审评资料把普通片 NDA 201281 与缓释片 NDA 208026 分开。共同品牌词根不能用来自行换算、替换或把旧药与新药一起使用。", "en": "They are not the same dosage form. FDA review material separates immediate-release NDA 201281 from extended-release NDA 208026. A shared brand stem cannot support self-conversion, substitution or using old and new supplies together." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "dosage-forms-are-part-of-medicine-identity", "how-to-read-a-drug-label", "generic-drugs-and-bioequivalence" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/jentadueto-xr/", "en": "https://origindrug.com/en/drugs/jentadueto-xr/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "tricor", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-30", "status": "published_traceable_archive" }, "names": { "brand": "TRICOR", "generic": "非诺贝特", "aliases": [ "Tricor", "fenofibrate", "fenofibrate tablets", "非诺贝特", "非诺贝特片", "NDA 021656", "0074-3173-90", "0074-3189-90", "TRICOR 48 mg", "TRICOR 145 mg", "DISCN" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "代谢", "sourceArchiveMarket": "美国：TRICOR 48 mg 与 145 mg 口服片的 2025-06 有日期品牌标签、两张官方包装面板及 FDA Orange Book 2026-08-26 数据。Orange Book 将 NDA 021656 两个规格均列为 RLD、DISCN；本页不把说明书仍可访问误写成当前有货。", "dosageFormClass": "非诺贝特口服片：48 mg 黄色 FI 无刻痕片、145 mg 白色 FO 无刻痕片；两款历史 90 片瓶装", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "2004-11-05（FDA NDA 021656 的 48 mg／145 mg 批准日期）", "archiveSponsorText": "AbbVie Inc.（2025 美国标签与 2026-08-26 FDA Orange Book 数据所列）" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [ "TRICOR", "Tricor", "非诺贝特片" ], "excludedProductCues": [ "TRILIPIX", "fenofibric acid", "非诺贝酸", "LOFIBRA", "LIPOFEN", "gemfibrozil", "吉非贝齐" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-tricor-fenofibrate-48mg-90-tablet-bottle-ndc-0074317390", "marketCode": "US", "labelVersion": { "zh": "DailyMed 美国有日期品牌标签（2025-06 修订）；FDA Orange Book 当前列为 DISCN，不代表仍有供应", "en": "Dated U.S. DailyMed brand label (revised Jun 2025); FDA Orange Book currently lists DISCN, not evidence of supply" }, "dosageForm": { "zh": "TRICOR 非诺贝特口服片", "en": "TRICOR fenofibrate oral tablet" }, "route": { "zh": "口服；标签要求整片吞服", "en": "oral; label says swallow whole" }, "routeCodes": [ "oral" ], "productCode": "NDC 0074-3173-90", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片非诺贝特 48 mg；90 片瓶装；美国品牌条目已停止销售", "en": "Fenofibrate 48 mg per tablet; 90-tablet bottle; U.S. brand listing discontinued" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=tricor-145-spl-02.jpg&archiveid=895466", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "非诺贝特", "en": "fenofibrate" }, "value": 48, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、换药比例或他汀换算值", "en": "labelled amount per tablet; not an individual tablet count, switching ratio or statin conversion" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 90, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-30", "currentLabelDisplayed": false, "ndcDirectoryListed": false, "marketAvailability": "historical_discontinued_brand", "marketingStartDate": null, "marketingEndDate": "2025-11-30", "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 90, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "黄色", "en": "yellow" }, "shape": { "zh": "椭圆形、无刻痕片", "en": "oval, unscored tablet" }, "imprint": "FI", "scoreStatus": "unscored_do_not_split", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_d897dd378a1f4e9b", "label": "DailyMed（NLM）：TRICOR 48 mg／145 mg 美国品牌标签（AbbVie；2025-06 修订；两张历史包装面板）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b693e68d-f812-4993-54b6-852e3517c344", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-tricor-fenofibrate-145mg-90-tablet-bottle-ndc-0074318990", "marketCode": "US", "labelVersion": { "zh": "DailyMed 美国有日期品牌标签（2025-06 修订）；FDA Orange Book 当前列为 DISCN，不代表仍有供应", "en": "Dated U.S. DailyMed brand label (revised Jun 2025); FDA Orange Book currently lists DISCN, not evidence of supply" }, "dosageForm": { "zh": "TRICOR 非诺贝特口服片", "en": "TRICOR fenofibrate oral tablet" }, "route": { "zh": "口服；标签要求整片吞服", "en": "oral; label says swallow whole" }, "routeCodes": [ "oral" ], "productCode": "NDC 0074-3189-90", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片非诺贝特 145 mg；90 片瓶装；美国品牌条目已停止销售", "en": "Fenofibrate 145 mg per tablet; 90-tablet bottle; U.S. brand listing discontinued" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=tricor-145-spl-03.jpg&archiveid=895466", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "非诺贝特", "en": "fenofibrate" }, "value": 145, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、换药比例或他汀换算值", "en": "labelled amount per tablet; not an individual tablet count, switching ratio or statin conversion" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 90, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-30", "currentLabelDisplayed": false, "ndcDirectoryListed": false, "marketAvailability": "historical_discontinued_brand", "marketingStartDate": null, "marketingEndDate": "2026-03-30", "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 90, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "白色", "en": "white" }, "shape": { "zh": "椭圆形、无刻痕片", "en": "oval, unscored tablet" }, "imprint": "FO", "scoreStatus": "unscored_do_not_split", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_d897dd378a1f4e9b", "label": "DailyMed（NLM）：TRICOR 48 mg／145 mg 美国品牌标签（AbbVie；2025-06 修订；两张历史包装面板）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b693e68d-f812-4993-54b6-852e3517c344", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-tricor-fenofibrate-48mg-90-tablet-bottle-ndc-0074317390", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=tricor-145-spl-02.jpg&archiveid=895466", "alt": "TRICOR 非诺贝特 48 mg、NDC 0074-3173-90、90 片瓶装的美国 DailyMed 历史标签展示面", "archiveMarket": "美国", "labelVersion": "DailyMed 有日期品牌标签，2025-06 修订；FDA Orange Book 当前列为 DISCN", "presentation": "TRICOR 每片非诺贝特 48 mg，黄色 FI 无刻痕片，NDC 0074-3173-90，90 片瓶装历史标签展示面。", "notice": "此图只对应所引有日期美国标签中的 48 mg 历史瓶装。它不代表 145 mg、其他非诺贝特产品、其他市场包装、当前供应或可购买状态，不用于鉴定真伪，也不生成个人片数。", "source": { "id": "src_d897dd378a1f4e9b", "label": "DailyMed（NLM）：TRICOR 48 mg／145 mg 美国品牌标签（AbbVie；2025-06 修订；两张历史包装面板）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b693e68d-f812-4993-54b6-852e3517c344", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "TRICOR 说明书放大阅读：48 mg 与 145 mg 是每片强度，历史包装不等于当前供应", "en": "TRICOR label reading: 48 mg and 145 mg are per-tablet strengths, and historical packs are not current supply" }, "summary": { "zh": "先核对 TRICOR、非诺贝特、准确强度、FI／FO 刻字、NDC 与目标市场，再读整片吞服、肾功能和联合用药警示。网页不会用 48 与 145 的算术关系替任何人换药或计算片数。", "en": "Check TRICOR, fenofibrate, exact strength, FI/FO imprint, NDC and market before reading whole-tablet, kidney-function and co-medication warnings. The site never uses arithmetic between 48 and 145 to switch a medicine or calculate tablets." }, "checks": [ { "zh": "48 mg 和 145 mg 分别是每片非诺贝特标示量。包装上的 90 Tablets 是瓶内数量，不是每次吃 90 片；145 也不是把 48 mg 片自行凑成三片的许可。", "en": "48 mg and 145 mg are labelled fenofibrate amounts per tablet. '90 Tablets' is the bottle count, not 90 tablets per dose, and 145 does not permit self-assembling three 48 mg tablets." }, { "zh": "2025 标签要求整片吞服，并明确不得压碎、掰开、溶解或咀嚼。两种片均无刻痕；吞咽困难或需改变规格时，应让药师或开方团队核对其他可行产品。", "en": "The 2025 label says swallow whole and not to crush, break, dissolve or chew. Both tablets are unscored. If swallowing is difficult or a strength change is considered, ask the pharmacist or prescriber to review another appropriate product." }, { "zh": "标签要求老年人的剂量选择依据肾功能；65 岁及以上、肾功能受损、甲状腺功能未控制，或与他汀、秋水仙碱同用时，肌病和横纹肌溶解风险需要优先核对。不要据网页自行停用或叠加。", "en": "The label bases geriatric dosage selection on kidney function. Age 65 or older, renal impairment, uncontrolled hypothyroidism, and use with a statin or colchicine require priority review of myopathy and rhabdomyolysis risk. Do not self-stop or self-add from the page." }, { "zh": "华法林等香豆素抗凝药、免疫抑制剂、可能伤肾的药和胆汁酸结合树脂都属于需核对的药单项目。异常肌痛/无力伴发热或不适、深色尿、黄疸、面唇舌喉肿胀或呼吸困难，应及时联系医疗人员；严重急性表现使用当地急救。", "en": "Coumarin anticoagulants such as warfarin, immunosuppressants, potentially nephrotoxic medicines and bile-acid resins belong on the review list. Unexplained muscle pain/weakness with fever or malaise, dark urine, jaundice, swelling of the face/lips/tongue/throat or breathing trouble requires prompt medical contact; severe acute features require local emergency care." } ], "source": { "id": "src_d897dd378a1f4e9b", "label": "DailyMed（NLM）：TRICOR 48 mg／145 mg 美国品牌标签（AbbVie；2025-06 修订；两张历史包装面板）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b693e68d-f812-4993-54b6-852e3517c344", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "TRICOR 怎样起作用：非诺贝特转化为非诺贝酸并激活 PPARα 相关通路", "en": "How TRICOR works: fenofibrate becomes fenofibric acid and activates PPAR-alpha-related pathways" }, "summary": { "zh": "标签将 TRICOR 描述为 PPARα 激动剂。非诺贝特经酯酶水解为活性代谢物非诺贝酸，影响脂蛋白脂肪酶及富含甘油三酯颗粒的代谢。机制帮助理解它与他汀不是同一种药，但不能决定个人是否需要、选择 48 或 145 mg、是否联合或能否替换。", "en": "The label describes TRICOR as a PPAR-alpha agonist. Fenofibrate is hydrolysed by esterases to active fenofibric acid and affects lipoprotein lipase and triglyceride-rich particle metabolism. This helps explain why it is not a statin, but cannot decide individual need, 48 versus 145 mg, combination or substitution." }, "checks": [ { "zh": "“降脂药”是宽泛类别。TRICOR 与 LIPITOR、CRESTOR、ZOCOR、VYTORIN、VASCEPA 的成分和机制不同，不能按毫克数自行换算、隔天轮换或叠加。", "en": "'Lipid-lowering medicine' is a broad category. TRICOR differs in ingredient and mechanism from LIPITOR, CRESTOR, ZOCOR, VYTORIN and VASCEPA and cannot be self-converted by milligrams, alternated by day or combined." }, { "zh": "标签中的 PPARα 机制不能替代血脂、肾肝功能、甲状腺状态、完整药单和既往反应的评估，也不能证明非诺贝特在所有人群中降低心血管事件。", "en": "The label's PPAR-alpha mechanism cannot replace assessment of lipids, kidney/liver function, thyroid status, the complete medicine list and prior response, and does not prove cardiovascular-event reduction in every population." }, { "zh": "全基因筛查不是网页替个人选择非诺贝特或他汀的默认答案。具体决定应围绕准确产品、临床问题、化验和完整药单由负责团队判断。", "en": "Whole-genome screening is not the site's default answer for choosing fenofibrate or a statin. A decision should be made by the responsible team around the exact product, clinical question, laboratory data and complete medicine list." } ], "source": { "id": "src_d897dd378a1f4e9b", "label": "DailyMed（NLM）：TRICOR 48 mg／145 mg 美国品牌标签（AbbVie；2025-06 修订；两张历史包装面板）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b693e68d-f812-4993-54b6-852e3517c344", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "TRICOR", "generic": "非诺贝特", "dosageFormClass": "非诺贝特口服片：48 mg 黄色 FI 无刻痕片、145 mg 白色 FO 无刻痕片；两款历史 90 片瓶装" }, "labelSource": { "id": "src_d897dd378a1f4e9b", "label": "DailyMed（NLM）：TRICOR 48 mg／145 mg 美国品牌标签（AbbVie；2025-06 修订；两张历史包装面板）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b693e68d-f812-4993-54b6-852e3517c344", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "productRoutes": [ { "source": { "id": "src_d897dd378a1f4e9b", "label": "DailyMed（NLM）：TRICOR 48 mg／145 mg 美国品牌标签（AbbVie；2025-06 修订；两张历史包装面板）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b693e68d-f812-4993-54b6-852e3517c344", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-30", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_10e511bf83430e3b", "label": "FDA Orange Book：TRICOR NDA 021656 的 48 mg／145 mg 均列为 RLD、DISCN（数据复核日 2026-08-30）", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-08-29", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_213ba84e19ef7b7a", "label": "FDA Drugs@FDA：TRICOR NDA 021656 官方申请检索入口", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=021656", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-08-30", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-30", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "TRICOR 是非诺贝特品牌片的美国历史档案。48 mg 与 145 mg 是两种不同的每片标示量，不是可以自己按三倍关系换算的片数。2025 标签要求整片吞服，不得压碎、掰开、溶解或咀嚼；老年人的剂量选择与肾功能有关，与他汀或秋水仙碱同处药单时还需优先核对肌病风险。FDA 当前数据已把两个品牌规格列为 DISCN，因此本页展示的是可追溯说明书和历史包装，不是当前库存或购买入口。", "history": "FDA 于 2004-11-05 批准 NDA 021656 的 TRICOR 48 mg 与 145 mg。2019 年 FDA 又批准相关安全标签补充。AbbVie 2025-06 标签保留了两个规格、整片吞服、老年与肾功能、他汀/秋水仙碱、抗凝药等阅读边界；其包装条目分别记录 2025-11-30 与 2026-03-30 的营销结束日期。FDA Orange Book 2026-08-26 数据把两个规格均列为 DISCN。", "sourceDocuments": [ { "id": "src_d897dd378a1f4e9b", "label": "DailyMed（NLM）：TRICOR 48 mg／145 mg 美国品牌标签（AbbVie；2025-06 修订；两张历史包装面板）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b693e68d-f812-4993-54b6-852e3517c344", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, { "id": "src_10e511bf83430e3b", "label": "FDA Orange Book：TRICOR NDA 021656 的 48 mg／145 mg 均列为 RLD、DISCN（数据复核日 2026-08-30）", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, { "id": "src_213ba84e19ef7b7a", "label": "FDA Drugs@FDA：TRICOR NDA 021656 官方申请检索入口", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=021656", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, { "id": "src_41c94f3376b38ce7", "label": "FDA：TRICOR／TRILIPIX 2019 补充批准信（NDA 021656/S-029）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021203Orig1s009,%20021656Orig1s029,%20022224Orig1s015ltr.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_regulatory_record", "documentKind": "regulatory_approval_letter", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" } ], "applicationNumber": "FDA NDA 021656（TRICOR 非诺贝特片 48 mg／145 mg；RLD；当前 DISCN）", "approvalTimeline": [ { "date": "2004-11-05", "title": { "zh": "FDA 批准 NDA 021656 的 48 mg／145 mg", "en": "FDA approved 48 mg and 145 mg under NDA 021656" }, "detail": { "zh": "Orange Book 当前数据保留两款产品的批准日期、RLD 与 DISCN 状态。该节点用于追溯产品史，不表示当前供应。", "en": "Current Orange Book data retain approval dates, RLD and DISCN status for both products. This traces product history and does not establish current supply." }, "source": { "id": "src_10e511bf83430e3b", "label": "FDA Orange Book：TRICOR NDA 021656 的 48 mg／145 mg 均列为 RLD、DISCN（数据复核日 2026-08-30）", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } }, { "date": "2019-05-08", "title": { "zh": "FDA 批准补充安全标签", "en": "FDA approved a supplemental safety-label change" }, "detail": { "zh": "补充批准信把 TRICOR 48 mg／145 mg、NDA 021656 与上市后安全标签更新相连。", "en": "The supplement letter links TRICOR 48 mg/145 mg and NDA 021656 to a postmarketing safety-label update." }, "source": { "id": "src_41c94f3376b38ce7", "label": "FDA：TRICOR／TRILIPIX 2019 补充批准信（NDA 021656/S-029）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021203Orig1s009,%20021656Orig1s029,%20022224Orig1s015ltr.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_regulatory_record", "documentKind": "regulatory_approval_letter", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" } }, { "date": "2026-08-30", "title": { "zh": "复核当前 FDA 产品状态", "en": "Current FDA product status reviewed" }, "detail": { "zh": "FDA Orange Book 数据将 48 mg 与 145 mg 两个 RLD 条目均列为 DISCN。该日期是本站复核日。", "en": "FDA Orange Book data list both 48 mg and 145 mg RLD rows as DISCN. This is the site's review date." }, "source": { "id": "src_10e511bf83430e3b", "label": "FDA Orange Book：TRICOR NDA 021656 的 48 mg／145 mg 均列为 RLD、DISCN（数据复核日 2026-08-30）", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "两种 RLD 品牌规格当前均列为 DISCN", "en": "Both RLD brand strengths currently listed as DISCN" }, "detail": { "zh": "保留 2025 有日期标签、两张官方历史包装面板和当前监管状态；不提供库存或购买路径。", "en": "Retains the dated 2025 label, two official historical package panels and current regulatory status; provides no stock or purchasing route." } }, { "market": { "zh": "中国大陆、欧盟、日本及其他市场", "en": "Mainland China, EU, Japan and other markets" }, "status": { "zh": "待逐项建立准确市场产品记录", "en": "Exact market-product records not established" }, "detail": { "zh": "不从美国品牌、通用名、mg 数字、颜色或 NDA 推定当地商品名、批准、包装、供应、原研/仿制关系或可替代性。", "en": "No local trade name, approval, pack, supply, originator/generic relationship or interchangeability is inferred from the U.S. brand, generic name, milligram figures, colours or NDA." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "TRICOR 48 mg 可以一次吃三片当 145 mg 吗？", "en": "Can three TRICOR 48 mg tablets be used as 145 mg?" }, "answer": { "zh": "不能据网页这样做。三片 48 mg 的算术合计是 144 mg，但产品强度、处方和肾功能相关选择不能由 1 mg 差值或算术替代决定；请让药师或开方团队核对准确处方。", "en": "A webpage cannot authorise that. Three 48 mg tablets arithmetically total 144 mg, but product strength, prescription and kidney-related selection cannot be decided by arithmetic or a 1 mg difference. Ask the pharmacist or prescriber to check the exact prescription." } }, { "question": { "zh": "TRICOR 和阿托伐他汀、瑞舒伐他汀是同一种降脂药吗？", "en": "Is TRICOR the same lipid medicine as atorvastatin or rosuvastatin?" }, "answer": { "zh": "不是。TRICOR 是非诺贝特，标签将其描述为 PPARα 激动剂；阿托伐他汀和瑞舒伐他汀属于他汀类。不同机制不建立自行联用、换算或轮换关系，且标签提示与他汀同用时肌病风险增加。", "en": "No. TRICOR is fenofibrate, described by the label as a PPAR-alpha agonist, while atorvastatin and rosuvastatin are statins. Different mechanisms do not establish self-combination, conversion or alternation, and the label warns of increased myopathy risk with a statin." } }, { "question": { "zh": "为什么 FDA 还能看到说明书，但档案写已停止销售？", "en": "Why is an FDA label visible if the record says discontinued?" }, "answer": { "zh": "监管档案会长期保留历史标签和批准记录。FDA Orange Book 当前数据将两个规格列为 DISCN，所以可访问说明书不能证明当前有货、可购买或重新上市。", "en": "Regulatory archives retain historical labels and approvals. Current FDA Orange Book data list both strengths as DISCN, so an accessible label does not prove stock, purchasing availability or relaunch." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "dosage-forms-are-part-of-medicine-identity", "how-to-read-a-drug-label", "generic-drugs-and-bioequivalence" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/tricor/", "en": "https://origindrug.com/en/drugs/tricor/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "bystolic", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-30", "status": "published_traceable_archive" }, "names": { "brand": "BYSTOLIC", "generic": "盐酸奈必洛尔片", "aliases": [ "Bystolic", "nebivolol", "nebivolol hydrochloride", "奈必洛尔", "盐酸奈必洛尔", "盐酸奈必洛尔片", "nebivolol tablets", "NDA 021742", "0456-1402-30", "0456-1405-90", "0456-1410-90", "0456-1420-90", "BYSTOLIC 2.5 mg", "BYSTOLIC 5 mg", "BYSTOLIC 10 mg", "BYSTOLIC 20 mg" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "心血管", "sourceArchiveMarket": "美国：DailyMed 当前 BYSTOLIC 品牌标签列出 2.5、5、10、20 mg 四种口服片及四个准确瓶装面板；FDA Orange Book 将 NDA 021742 四个规格均列为处方 RLD，并将 20 mg 列为 RS。加拿大：Health Canada DPD 当前将 BYSTOLIC 2.5、5、10、20 mg 均列为 Marketed。监管在册、官方包装图与具体渠道实时库存属于不同证据层级。", "dosageFormClass": "盐酸奈必洛尔口服片：2.5 mg、5 mg、10 mg、20 mg；四种三角形无刻痕片与准确美国瓶装身份", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "2007-12-17（FDA NDA 021742 的 2.5／5／10 mg 原始批准；20 mg 于 2008-10-08 批准）", "archiveSponsorText": "Allergan Sales LLC / AbbVie（美国 FDA 监管资料）；AbbVie Corporation（加拿大 DPD）" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [ "BYSTOLIC", "Bystolic", "盐酸奈必洛尔片" ], "excludedProductCues": [ "BYVALSON", "nebivolol and valsartan", "nebivolol/valsartan", "奈必洛尔缬沙坦" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-bystolic-nebivolol-2-5mg-30-tablet-bottle-ndc-0456140230", "marketCode": "US", "labelVersion": { "zh": "DailyMed 美国当前公开品牌标签（SPL v31；标签正文 2024-08 修订）；准确包装身份，不代表实时库存", "en": "Current U.S. DailyMed brand label (SPL v31; label text revised Aug 2024); exact pack identity, not real-time stock" }, "dosageForm": { "zh": "BYSTOLIC 盐酸奈必洛尔口服片", "en": "BYSTOLIC nebivolol hydrochloride oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 0456-1402-30", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片奈必洛尔 2.5 mg（以盐酸盐形式）；30 片瓶装", "en": "2.5 mg nebivolol per tablet (as hydrochloride); 30-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=bystolic-03.jpg&setid=8b8ad213-1dc8-454e-a524-075685c0e1a8", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "奈必洛尔（以盐酸盐形式）", "en": "nebivolol (as hydrochloride)" }, "value": 2.5, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、换药比例或 β 受体阻滞剂换算值", "en": "labelled amount per tablet; not an individual tablet count, switching ratio or beta-blocker conversion" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-30", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "current_regulatory_listing_not_live_stock", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 30, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "蓝色", "en": "blue" }, "shape": { "zh": "三角形、无刻痕片，约 8 mm", "en": "triangular, unscored tablet, approximately 8 mm" }, "imprint": "2;1;2;FL", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_065682171ec6e5bb", "label": "DailyMed（NLM）：BYSTOLIC 奈必洛尔美国当前公开品牌标签（SPL v31；标签正文 2024-08 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8b8ad213-1dc8-454e-a524-075685c0e1a8", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-bystolic-nebivolol-5mg-90-tablet-bottle-ndc-0456140590", "marketCode": "US", "labelVersion": { "zh": "DailyMed 美国当前公开品牌标签（SPL v31；标签正文 2024-08 修订）；准确包装身份，不代表实时库存", "en": "Current U.S. DailyMed brand label (SPL v31; label text revised Aug 2024); exact pack identity, not real-time stock" }, "dosageForm": { "zh": "BYSTOLIC 盐酸奈必洛尔口服片", "en": "BYSTOLIC nebivolol hydrochloride oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 0456-1405-90", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片奈必洛尔 5 mg（以盐酸盐形式）；90 片瓶装", "en": "5 mg nebivolol per tablet (as hydrochloride); 90-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=bystolic-04.jpg&setid=8b8ad213-1dc8-454e-a524-075685c0e1a8", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "奈必洛尔（以盐酸盐形式）", "en": "nebivolol (as hydrochloride)" }, "value": 5, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、换药比例或 β 受体阻滞剂换算值", "en": "labelled amount per tablet; not an individual tablet count, switching ratio or beta-blocker conversion" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 90, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-30", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "current_regulatory_listing_not_live_stock", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 90, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "米色至浅棕色", "en": "beige to light brown" }, "shape": { "zh": "三角形、无刻痕片，约 10 mm", "en": "triangular, unscored tablet, approximately 10 mm" }, "imprint": "5;FL", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_065682171ec6e5bb", "label": "DailyMed（NLM）：BYSTOLIC 奈必洛尔美国当前公开品牌标签（SPL v31；标签正文 2024-08 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8b8ad213-1dc8-454e-a524-075685c0e1a8", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-bystolic-nebivolol-10mg-90-tablet-bottle-ndc-0456141090", "marketCode": "US", "labelVersion": { "zh": "DailyMed 美国当前公开品牌标签（SPL v31；标签正文 2024-08 修订）；准确包装身份，不代表实时库存", "en": "Current U.S. DailyMed brand label (SPL v31; label text revised Aug 2024); exact pack identity, not real-time stock" }, "dosageForm": { "zh": "BYSTOLIC 盐酸奈必洛尔口服片", "en": "BYSTOLIC nebivolol hydrochloride oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 0456-1410-90", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片奈必洛尔 10 mg（以盐酸盐形式）；90 片瓶装", "en": "10 mg nebivolol per tablet (as hydrochloride); 90-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=bystolic-05.jpg&setid=8b8ad213-1dc8-454e-a524-075685c0e1a8", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "奈必洛尔（以盐酸盐形式）", "en": "nebivolol (as hydrochloride)" }, "value": 10, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、换药比例或 β 受体阻滞剂换算值", "en": "labelled amount per tablet; not an individual tablet count, switching ratio or beta-blocker conversion" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 90, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-30", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "current_regulatory_listing_not_live_stock", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 90, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "紫色", "en": "purple" }, "shape": { "zh": "三角形、无刻痕片，约 10 mm", "en": "triangular, unscored tablet, approximately 10 mm" }, "imprint": "10;FL", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_065682171ec6e5bb", "label": "DailyMed（NLM）：BYSTOLIC 奈必洛尔美国当前公开品牌标签（SPL v31；标签正文 2024-08 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8b8ad213-1dc8-454e-a524-075685c0e1a8", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-bystolic-nebivolol-20mg-90-tablet-bottle-ndc-0456142090", "marketCode": "US", "labelVersion": { "zh": "DailyMed 美国当前公开品牌标签（SPL v31；标签正文 2024-08 修订）；准确包装身份，不代表实时库存", "en": "Current U.S. DailyMed brand label (SPL v31; label text revised Aug 2024); exact pack identity, not real-time stock" }, "dosageForm": { "zh": "BYSTOLIC 盐酸奈必洛尔口服片", "en": "BYSTOLIC nebivolol hydrochloride oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 0456-1420-90", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片奈必洛尔 20 mg（以盐酸盐形式）；90 片瓶装；FDA RS", "en": "20 mg nebivolol per tablet (as hydrochloride); 90-tablet bottle; FDA RS" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=bystolic-06.jpg&setid=8b8ad213-1dc8-454e-a524-075685c0e1a8", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "奈必洛尔（以盐酸盐形式）", "en": "nebivolol (as hydrochloride)" }, "value": 20, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、换药比例或 β 受体阻滞剂换算值", "en": "labelled amount per tablet; not an individual tablet count, switching ratio or beta-blocker conversion" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 90, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-30", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "current_regulatory_listing_not_live_stock", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 90, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "蓝色", "en": "blue" }, "shape": { "zh": "三角形、无刻痕片，约 10 mm", "en": "triangular, unscored tablet, approximately 10 mm" }, "imprint": "20;FL", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_065682171ec6e5bb", "label": "DailyMed（NLM）：BYSTOLIC 奈必洛尔美国当前公开品牌标签（SPL v31；标签正文 2024-08 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8b8ad213-1dc8-454e-a524-075685c0e1a8", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-bystolic-nebivolol-2-5mg-30-tablet-bottle-ndc-0456140230", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=bystolic-03.jpg&setid=8b8ad213-1dc8-454e-a524-075685c0e1a8", "alt": "BYSTOLIC 奈必洛尔 2.5 mg、NDC 0456-1402-30、30 片瓶装的美国 DailyMed 官方标签展示面", "archiveMarket": "美国", "labelVersion": "DailyMed SPL v31；标签正文 2024-08 修订", "presentation": "BYSTOLIC 每片奈必洛尔 2.5 mg，蓝色三角形无刻痕片，NDC 0456-1402-30，30 片瓶装。", "notice": "此图只对应当前美国标签中的 2.5 mg、NDC 0456-1402-30、30 片瓶装；不代表 5、10、20 mg、加拿大或其他市场包装、实时库存或个人片数，不用于鉴定真伪。", "source": { "id": "src_065682171ec6e5bb", "label": "DailyMed（NLM）：BYSTOLIC 奈必洛尔美国当前公开品牌标签（SPL v31；标签正文 2024-08 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8b8ad213-1dc8-454e-a524-075685c0e1a8", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "BYSTOLIC 说明书放大阅读：先核对脉搏、突然停药与重复 β 受体阻滞剂", "en": "BYSTOLIC label reading: review pulse, abrupt withdrawal and duplicate beta blockers first" }, "summary": { "zh": "先核对 BYSTOLIC、奈必洛尔、准确强度、NDC 与目标市场，再把低脉搏、头晕/晕厥、胸痛、呼吸症状、糖尿病和完整药单放在一起核对。四个 mg 数字不是与另一种 β 受体阻滞剂换算的比例。", "en": "Check BYSTOLIC, nebivolol, exact strength, NDC and target market, then review low pulse, dizziness/fainting, chest pain, breathing symptoms, diabetes and the complete medicine list together. The four milligram figures are not conversion ratios to another beta blocker." }, "checks": [ { "zh": "2.5、5、10、20 mg 分别是每片奈必洛尔标示量；30 或 90 Tablets 是瓶内片数，不是每次服用量。无刻痕只是身份线索，不能从网页推导自行掰片许可。", "en": "2.5, 5, 10 and 20 mg are labelled nebivolol amounts per tablet. '30' or '90 Tablets' is the bottle count, not the amount per dose. An unscored appearance is an identity clue and does not let the site infer self-splitting permission." }, { "zh": "标签警告不要突然停止 BYSTOLIC，尤其是冠心病患者；突然停用 β 受体阻滞剂可能使心绞痛或心肌梗死风险加重。不要因一次脉搏或血压读数自行停药，胸痛或严重急性症状使用当地急救。", "en": "The label warns against abruptly stopping BYSTOLIC, especially with coronary artery disease, because abrupt beta-blocker withdrawal may worsen angina or myocardial-infarction risk. Do not stop from one pulse or blood-pressure reading; use local emergency care for chest pain or another severe acute symptom." }, { "zh": "药单中若同时出现另一种 β 受体阻滞剂（如 TOPROL-XL、LOPRESSOR、美托洛尔、比索洛尔、TENORMIN、INDERAL LA、COREG），或地高辛、地尔硫䓬/维拉帕米、可乐定，应优先让药师或开方团队核对重复作用、心率、传导与低血压风险。", "en": "If another beta blocker (such as TOPROL-XL, LOPRESSOR/metoprolol, bisoprolol, TENORMIN, INDERAL LA or COREG), digoxin, diltiazem/verapamil or clonidine appears on the list, ask a pharmacist or prescriber to prioritise duplicate effects, heart rate, conduction and hypotension risk." }, { "zh": "标签提示奈必洛尔可能掩盖低血糖的一些警示表现；糖尿病患者不要只靠心跳加快判断低血糖。明显晕厥、严重心动过缓、呼吸困难、面唇舌喉肿胀或持续胸痛需要及时医疗评估，严重急性表现使用当地急救。", "en": "The label says nebivolol may mask some warning features of hypoglycaemia; a person with diabetes should not rely only on a racing heart to detect low glucose. Fainting, severe bradycardia, breathing difficulty, swelling of the face/lips/tongue/throat or persistent chest pain requires prompt medical assessment; severe acute features require local emergency care." } ], "source": { "id": "src_065682171ec6e5bb", "label": "DailyMed（NLM）：BYSTOLIC 奈必洛尔美国当前公开品牌标签（SPL v31；标签正文 2024-08 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8b8ad213-1dc8-454e-a524-075685c0e1a8", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "BYSTOLIC 怎样起作用：以 β1 受体阻滞为主，并有一氧化氮相关血管舒张线索", "en": "How BYSTOLIC works: primarily beta-1 blockade with nitric-oxide-associated vasodilation" }, "summary": { "zh": "当前标签描述奈必洛尔在较低浓度下以 β1 选择性阻滞为主，并提示奈必洛尔及其代谢物与内皮来源一氧化氮相关血管舒张有关。机制帮助理解它为什么会影响心率与血压，但不能决定个人剂量、能否与另一种减慢心率药联用或何时停换。", "en": "The current label describes nebivolol as predominantly beta-1 selective at lower concentrations and notes nitric-oxide-associated vasodilation involving nebivolol and its metabolites. This helps explain effects on heart rate and blood pressure but cannot determine an individual's dose, combination with another rate-slowing medicine or withdrawal/switching." }, "checks": [ { "zh": "“同为 β 受体阻滞剂”不表示 BYSTOLIC、美托洛尔、比索洛尔、阿替洛尔、普萘洛尔和卡维地洛可以按 mg 一对一换算或轮换服用。每款药的成分、选择性、剂型和标签边界不同。", "en": "Sharing the beta-blocker class does not make BYSTOLIC, metoprolol, bisoprolol, atenolol, propranolol and carvedilol one-to-one milligram conversions or medicines to alternate. Ingredient, selectivity, form and label boundaries differ." }, { "zh": "强 CYP2D6 抑制剂可能增加奈必洛尔暴露，标签举例包括氟西汀和帕罗西汀。用药核对比仅凭商品名或一次血压值更重要，不应自行停用精神科药或降压药。", "en": "Strong CYP2D6 inhibitors may increase nebivolol exposure; the label gives fluoxetine and paroxetine as examples. Medicine-list review is more useful than relying on a brand name or one blood-pressure reading, and neither psychiatric nor blood-pressure medicine should be self-stopped." }, { "zh": "标签讨论 CYP2D6 快/慢代谢者的暴露差异，但同时说明其临床重要性通常低于仅靠母体药物作用的情形，因为活性代谢物也有贡献。这不是网页默认推荐全基因组检测或据基因结果自行换药的依据。", "en": "The label discusses CYP2D6 extensive/poor-metaboliser exposure differences, while noting that clinical importance is usually less than for drugs acting only through the parent compound because active metabolites also contribute. This is not a basis for default whole-genome testing or self-switching from a genetic result." } ], "source": { "id": "src_065682171ec6e5bb", "label": "DailyMed（NLM）：BYSTOLIC 奈必洛尔美国当前公开品牌标签（SPL v31；标签正文 2024-08 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8b8ad213-1dc8-454e-a524-075685c0e1a8", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "BYSTOLIC", "generic": "盐酸奈必洛尔片", "dosageFormClass": "盐酸奈必洛尔口服片：2.5 mg、5 mg、10 mg、20 mg；四种三角形无刻痕片与准确美国瓶装身份" }, "labelSource": { "id": "src_065682171ec6e5bb", "label": "DailyMed（NLM）：BYSTOLIC 奈必洛尔美国当前公开品牌标签（SPL v31；标签正文 2024-08 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8b8ad213-1dc8-454e-a524-075685c0e1a8", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "productRoutes": [ { "source": { "id": "src_065682171ec6e5bb", "label": "DailyMed（NLM）：BYSTOLIC 奈必洛尔美国当前公开品牌标签（SPL v31；标签正文 2024-08 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8b8ad213-1dc8-454e-a524-075685c0e1a8", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-30", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_10e511bf83430e3b", "label": "FDA Orange Book：BYSTOLIC NDA 021742 四个口服片规格均列为 RLD，20 mg 同时列为 RS（数据复核日 2026-08-30）", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-08-29", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_38e20404283186a8", "label": "FDA Drugs@FDA：BYSTOLIC NDA 021742 官方申请检索入口", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=021742", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-08-30", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-30", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "BYSTOLIC 是奈必洛尔的美国品牌片。它属于 β 受体阻滞剂，但不等于美托洛尔、比索洛尔、阿替洛尔、普萘洛尔或卡维地洛，不能按毫克数自行换算、轮换或叠加。老人查看这款药时，先核对准确强度和药盒，再把静息脉搏过慢、头晕或晕厥、糖尿病低血糖警示、肾肝功能和完整药单带给医生或药师。标签警告不要突然停用；网页不生成个人片数、频次、停换药或补服方案。", "history": "FDA 于 2007-12-17 批准 BYSTOLIC NDA 021742 的 2.5、5、10 mg，20 mg 于 2008-10-08 批准。当前美国标签写有 Initial U.S. Approval: 2007，并保留四个品牌规格。标签还记录该产品曾由 Mylan Laboratories 授权，并涉及 Janssen Pharmaceutica N.V. 的许可历史；当前品牌监管记录由 Allergan Sales LLC / AbbVie 体系维护。加拿大官方 DPD 当前列出四种规格均为 Marketed。上述节点用于追溯产品与市场记录，不等于具体药房库存。", "sourceDocuments": [ { "id": "src_065682171ec6e5bb", "label": "DailyMed（NLM）：BYSTOLIC 奈必洛尔美国当前公开品牌标签（SPL v31；标签正文 2024-08 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8b8ad213-1dc8-454e-a524-075685c0e1a8", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, { "id": "src_10e511bf83430e3b", "label": "FDA Orange Book：BYSTOLIC NDA 021742 四个口服片规格均列为 RLD，20 mg 同时列为 RS（数据复核日 2026-08-30）", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, { "id": "src_f569b57eee87a182", "label": "Health Canada：药品产品数据库（DPD）当前访问页；在库内核对 BYSTOLIC 与 DIN", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_lookup_entry", "documentKind": "regulatory_lookup", "market": "CA", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-09-13", "reviewedAt": "2026-09-13" }, { "id": "src_38e20404283186a8", "label": "FDA Drugs@FDA：BYSTOLIC NDA 021742 官方申请检索入口", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=021742", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" } ], "applicationNumber": "FDA NDA 021742（BYSTOLIC／nebivolol；四规格 RLD；20 mg 为 RS）", "approvalTimeline": [ { "date": "2007-12-17", "title": { "zh": "FDA 批准 BYSTOLIC 2.5／5／10 mg", "en": "FDA approved BYSTOLIC 2.5, 5 and 10 mg" }, "detail": { "zh": "Orange Book 当前数据将三款规格与 NDA 021742、处方 RLD 和该批准日期相连。", "en": "Current Orange Book data connect the three strengths with NDA 021742, prescription RLD status and this approval date." }, "source": { "id": "src_10e511bf83430e3b", "label": "FDA Orange Book：BYSTOLIC NDA 021742 四个口服片规格均列为 RLD，20 mg 同时列为 RS（数据复核日 2026-08-30）", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } }, { "date": "2008-10-08", "title": { "zh": "FDA 批准 BYSTOLIC 20 mg", "en": "FDA approved BYSTOLIC 20 mg" }, "detail": { "zh": "Orange Book 当前数据将 20 mg 列为 RLD 与 RS。RS 只是一项美国参比标准监管字段，不是个人优选药结论。", "en": "Current Orange Book data list 20 mg as both RLD and RS. RS is a U.S. regulatory reference-standard field, not an individual preferred-medicine conclusion." }, "source": { "id": "src_10e511bf83430e3b", "label": "FDA Orange Book：BYSTOLIC NDA 021742 四个口服片规格均列为 RLD，20 mg 同时列为 RS（数据复核日 2026-08-30）", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } }, { "date": "2024-08", "title": { "zh": "美国品牌标签修订", "en": "U.S. brand label revised" }, "detail": { "zh": "当前 DailyMed SPL v31 保留四种规格和处方信息；本页据此更新包装、禁忌、停药、相互作用和老人阅读边界。", "en": "Current DailyMed SPL v31 retains four strengths and prescribing information; this page uses it for package, contraindication, withdrawal, interaction and older-reader boundaries." }, "source": { "id": "src_065682171ec6e5bb", "label": "DailyMed（NLM）：BYSTOLIC 奈必洛尔美国当前公开品牌标签（SPL v31；标签正文 2024-08 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8b8ad213-1dc8-454e-a524-075685c0e1a8", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "四个处方 RLD 规格当前在册；20 mg 为 RS", "en": "Four prescription RLD strengths currently listed; 20 mg is the RS" }, "detail": { "zh": "当前标签逐一建立四个准确瓶装面板；监管在册和标签面板不代表具体药房实时库存或购买资格。", "en": "The current label establishes four exact bottle panels. Regulatory listing and label panels do not establish live pharmacy stock or purchasing eligibility." } }, { "market": { "zh": "加拿大", "en": "Canada" }, "status": { "zh": "四个规格当前均列为 Marketed", "en": "All four strengths currently listed as Marketed" }, "detail": { "zh": "Health Canada DPD 列出 DIN 02398990、02399008、02399016、02399024 与 AbbVie Corporation；不把加拿大状态外推美国或其他市场。", "en": "Health Canada's DPD lists DIN 02398990, 02399008, 02399016 and 02399024 with AbbVie Corporation. Canadian status is not projected onto the United States or another market." } }, { "market": { "zh": "中国大陆、欧盟、日本及其他市场", "en": "Mainland China, EU, Japan and other markets" }, "status": { "zh": "待逐项建立准确现行监管产品记录", "en": "Exact current regulatory product records not established" }, "detail": { "zh": "不从美国/加拿大商品名、通用名、mg 数字或包装颜色推定当地批准、品牌、供应、原研/参比关系或可替代性。", "en": "No local approval, brand, supply, originator/reference relationship or interchangeability is inferred from U.S./Canadian names, milligram figures or pack colours." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "BYSTOLIC 和美托洛尔、比索洛尔是一种药吗？", "en": "Is BYSTOLIC the same medicine as metoprolol or bisoprolol?" }, "answer": { "zh": "不是。它们都可能属于 β 受体阻滞剂，但活性成分和产品不同，不能按 mg 自行换算、一天一种轮换或重复叠加。请让药师或开方团队核对准确药盒和目的。", "en": "No. They may share the beta-blocker class, but active ingredients and products differ. Do not self-convert milligrams, alternate by day or duplicate them. Ask the pharmacist or prescriber to review the exact packs and purposes." } }, { "question": { "zh": "脉搏慢或头晕，可以立刻停药吗？", "en": "Can the medicine be stopped immediately for a slow pulse or dizziness?" }, "answer": { "zh": "网页不能决定停药。标签同时提示严重心动过缓等风险和突然停用的冠心病风险。记录症状、脉搏、血压及全部药盒，及时联系负责团队；晕厥、胸痛、呼吸困难或其他严重急性表现使用当地急救。", "en": "A webpage cannot decide withdrawal. The label covers risks such as severe bradycardia and coronary risk from abrupt discontinuation. Record symptoms, pulse, blood pressure and every pack, and contact the responsible team promptly; use local emergency care for fainting, chest pain, breathing difficulty or another severe acute feature." } }, { "question": { "zh": "需要做 CYP2D6 或全基因组检测才能用这款药吗？", "en": "Is CYP2D6 or whole-genome testing required to use this medicine?" }, "answer": { "zh": "当前标签讨论 CYP2D6 暴露差异和强抑制剂相互作用，但没有把全基因组检测写成所有人的默认前提。先核对完整药单、脉搏、肾肝功能、既往反应和临床问题；是否需要特定检测由负责团队判断。", "en": "The current label discusses CYP2D6 exposure differences and strong-inhibitor interactions, but does not make whole-genome testing a default prerequisite for everyone. Review the complete medicine list, pulse, kidney/liver function, prior response and clinical question first; the responsible team decides whether a specific test is needed." } }, { "question": { "zh": "无刻痕片能不能掰开？", "en": "Can an unscored tablet be split?" }, "answer": { "zh": "无刻痕是准确产品外观线索，但网页不会由此单独推断可以或绝对不可以分片。吞咽困难、需更改强度或药片破损时，请带准确药盒让药师核对该产品说明书和可行替代剂型。", "en": "An unscored tablet is an exact-product appearance clue, but the site does not infer splitting permission or prohibition from that fact alone. For swallowing difficulty, strength changes or a damaged tablet, take the exact pack to a pharmacist to review the product label and an appropriate alternative form." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "dosage-forms-are-part-of-medicine-identity", "how-to-read-a-drug-label", "generic-drugs-and-bioequivalence" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/bystolic/", "en": "https://origindrug.com/en/drugs/bystolic/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "coreg-cr", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-30", "status": "published_traceable_archive" }, "names": { "brand": "COREG CR", "generic": "磷酸卡维地洛缓释胶囊", "aliases": [ "Coreg CR", "carvedilol phosphate", "carvedilol phosphate extended-release capsules", "磷酸卡维地洛", "磷酸卡维地洛缓释胶囊", "卡维地洛缓释胶囊", "carvedilol phosphate extended release", "NDA 022012", "80725-383-13", "80725-385-13", "80725-387-13", "80725-388-13", "COREG CR 10 mg", "COREG CR 20 mg", "COREG CR 40 mg", "COREG CR 80 mg" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "心血管", "sourceArchiveMarket": "美国：DailyMed 当前 COREG CR 标签列出 10、20、40、80 mg 四种磷酸卡维地洛口服缓释胶囊和四个准确 30 粒瓶装面板；FDA Orange Book 将 NDA 022012 四个规格均列为处方 RLD，RS 均为 No。监管在册、官方包装图和具体药房实时库存属于不同证据层级。", "dosageFormClass": "磷酸卡维地洛口服缓释胶囊：10 mg、20 mg、40 mg、80 mg；不是 COREG 卡维地洛普通片的另一种包装", "dosageFormClassCode": "oral_modified_release", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "2006-10-20（FDA NDA 022012 原始申请批准）", "archiveSponsorText": "Waylis Therapeutics LLC（DailyMed 与 FDA 当前美国监管记录）" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [ "COREG CR", "Coreg CR", "磷酸卡维地洛缓释胶囊" ], "excludedProductCues": [ "COREG carvedilol tablets", "carvedilol immediate-release tablets", "卡维地洛片", "卡维地洛普通片" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-coreg-cr-carvedilol-phosphate-10mg-30-capsule-bottle-ndc-8072538313", "marketCode": "US", "labelVersion": { "zh": "DailyMed 美国当前公开标签（SPL v3；2025-04-25 生效）；准确包装身份，不代表实时库存", "en": "Current U.S. DailyMed label (SPL v3; effective 25 Apr 2025); exact pack identity, not real-time stock" }, "dosageForm": { "zh": "COREG CR 磷酸卡维地洛口服缓释胶囊", "en": "COREG CR carvedilol phosphate oral extended-release capsule" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 80725-383-13", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_capsule", "primaryDisplay": { "zh": "每粒磷酸卡维地洛 10 mg；30 粒瓶装", "en": "10 mg carvedilol phosphate per capsule; 30-capsule bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=coreg-07.jpg&setid=d3625d78-6eb6-41fe-8f6f-664965c104c4&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "磷酸卡维地洛", "en": "carvedilol phosphate" }, "value": 10, "unit": "mg", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒标签标示量；不是 COREG 普通片换算值或个人粒数", "en": "labelled amount per capsule; not a COREG immediate-release conversion or individual capsule count" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "塑料瓶", "en": "plastic bottle" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-30", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "current_regulatory_listing_not_live_stock", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 30, "unit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "physicalClues": { "color": { "zh": "白色／绿色", "en": "white / green" }, "shape": { "zh": "胶囊，约 14 mm；胶囊接缝不是可分剂量刻痕", "en": "capsule, approximately 14 mm; the capsule seam is not a dose-dividing score" }, "imprint": "GSLGK;10mg", "scoreStatus": "capsule_not_scored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_4455fd9a0a218ffe", "label": "DailyMed（NLM）：COREG CR 磷酸卡维地洛缓释胶囊当前美国公开标签（SPL v3；2025-04-25 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d3625d78-6eb6-41fe-8f6f-664965c104c4", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-coreg-cr-carvedilol-phosphate-20mg-30-capsule-bottle-ndc-8072538513", "marketCode": "US", "labelVersion": { "zh": "DailyMed 美国当前公开标签（SPL v3；2025-04-25 生效）；准确包装身份，不代表实时库存", "en": "Current U.S. DailyMed label (SPL v3; effective 25 Apr 2025); exact pack identity, not real-time stock" }, "dosageForm": { "zh": "COREG CR 磷酸卡维地洛口服缓释胶囊", "en": "COREG CR carvedilol phosphate oral extended-release capsule" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 80725-385-13", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_capsule", "primaryDisplay": { "zh": "每粒磷酸卡维地洛 20 mg；30 粒瓶装", "en": "20 mg carvedilol phosphate per capsule; 30-capsule bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=coreg-08.jpg&setid=d3625d78-6eb6-41fe-8f6f-664965c104c4&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "磷酸卡维地洛", "en": "carvedilol phosphate" }, "value": 20, "unit": "mg", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒标签标示量；不是 COREG 普通片换算值或个人粒数", "en": "labelled amount per capsule; not a COREG immediate-release conversion or individual capsule count" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "塑料瓶", "en": "plastic bottle" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-30", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "current_regulatory_listing_not_live_stock", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 30, "unit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "physicalClues": { "color": { "zh": "白色／黄色", "en": "white / yellow" }, "shape": { "zh": "胶囊，约 16 mm；胶囊接缝不是可分剂量刻痕", "en": "capsule, approximately 16 mm; the capsule seam is not a dose-dividing score" }, "imprint": "GSMHV;20mg", "scoreStatus": "capsule_not_scored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_4455fd9a0a218ffe", "label": "DailyMed（NLM）：COREG CR 磷酸卡维地洛缓释胶囊当前美国公开标签（SPL v3；2025-04-25 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d3625d78-6eb6-41fe-8f6f-664965c104c4", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-coreg-cr-carvedilol-phosphate-40mg-30-capsule-bottle-ndc-8072538713", "marketCode": "US", "labelVersion": { "zh": "DailyMed 美国当前公开标签（SPL v3；2025-04-25 生效）；准确包装身份，不代表实时库存", "en": "Current U.S. DailyMed label (SPL v3; effective 25 Apr 2025); exact pack identity, not real-time stock" }, "dosageForm": { "zh": "COREG CR 磷酸卡维地洛口服缓释胶囊", "en": "COREG CR carvedilol phosphate oral extended-release capsule" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 80725-387-13", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_capsule", "primaryDisplay": { "zh": "每粒磷酸卡维地洛 40 mg；30 粒瓶装", "en": "40 mg carvedilol phosphate per capsule; 30-capsule bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=coreg-09.jpg&setid=d3625d78-6eb6-41fe-8f6f-664965c104c4&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "磷酸卡维地洛", "en": "carvedilol phosphate" }, "value": 40, "unit": "mg", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒标签标示量；不是 COREG 普通片换算值或个人粒数", "en": "labelled amount per capsule; not a COREG immediate-release conversion or individual capsule count" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "塑料瓶", "en": "plastic bottle" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-30", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "current_regulatory_listing_not_live_stock", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 30, "unit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "physicalClues": { "color": { "zh": "绿色／黄色", "en": "green / yellow" }, "shape": { "zh": "胶囊，约 18 mm；胶囊接缝不是可分剂量刻痕", "en": "capsule, approximately 18 mm; the capsule seam is not a dose-dividing score" }, "imprint": "GSETX;40mg", "scoreStatus": "capsule_not_scored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_4455fd9a0a218ffe", "label": "DailyMed（NLM）：COREG CR 磷酸卡维地洛缓释胶囊当前美国公开标签（SPL v3；2025-04-25 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d3625d78-6eb6-41fe-8f6f-664965c104c4", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-coreg-cr-carvedilol-phosphate-80mg-30-capsule-bottle-ndc-8072538813", "marketCode": "US", "labelVersion": { "zh": "DailyMed 美国当前公开标签（SPL v3；2025-04-25 生效）；准确包装身份，不代表实时库存", "en": "Current U.S. DailyMed label (SPL v3; effective 25 Apr 2025); exact pack identity, not real-time stock" }, "dosageForm": { "zh": "COREG CR 磷酸卡维地洛口服缓释胶囊", "en": "COREG CR carvedilol phosphate oral extended-release capsule" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 80725-388-13", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_capsule", "primaryDisplay": { "zh": "每粒磷酸卡维地洛 80 mg；30 粒瓶装", "en": "80 mg carvedilol phosphate per capsule; 30-capsule bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=coreg-10.jpg&setid=d3625d78-6eb6-41fe-8f6f-664965c104c4&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "磷酸卡维地洛", "en": "carvedilol phosphate" }, "value": 80, "unit": "mg", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒标签标示量；不是 COREG 普通片换算值或个人粒数", "en": "labelled amount per capsule; not a COREG immediate-release conversion or individual capsule count" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "塑料瓶", "en": "plastic bottle" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-30", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "current_regulatory_listing_not_live_stock", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 30, "unit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "physicalClues": { "color": { "zh": "白色", "en": "white" }, "shape": { "zh": "胶囊，约 22 mm；胶囊接缝不是可分剂量刻痕", "en": "capsule, approximately 22 mm; the capsule seam is not a dose-dividing score" }, "imprint": "GSF1L;80mg", "scoreStatus": "capsule_not_scored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_4455fd9a0a218ffe", "label": "DailyMed（NLM）：COREG CR 磷酸卡维地洛缓释胶囊当前美国公开标签（SPL v3；2025-04-25 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d3625d78-6eb6-41fe-8f6f-664965c104c4", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-coreg-cr-carvedilol-phosphate-10mg-30-capsule-bottle-ndc-8072538313", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=coreg-07.jpg&setid=d3625d78-6eb6-41fe-8f6f-664965c104c4&type=img", "alt": "COREG CR 磷酸卡维地洛 10 mg、NDC 80725-383-13、30 粒瓶装的美国 DailyMed 官方标签展示面", "archiveMarket": "美国", "labelVersion": "DailyMed SPL v3；2025-04-25 生效", "presentation": "COREG CR 每粒磷酸卡维地洛 10 mg，白色／绿色胶囊，NDC 80725-383-13，30 粒瓶装。", "notice": "此图只对应当前美国标签中的 10 mg、NDC 80725-383-13、30 粒瓶装；不代表 20、40、80 mg、COREG 普通片、其他市场包装、实时库存或个人粒数，不用于鉴定真伪。", "source": { "id": "src_4455fd9a0a218ffe", "label": "DailyMed（NLM）：COREG CR 磷酸卡维地洛缓释胶囊当前美国公开标签（SPL v3；2025-04-25 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d3625d78-6eb6-41fe-8f6f-664965c104c4", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "COREG CR 说明书放大阅读：缓释胶囊不是普通片；微丸必须保持完整", "en": "COREG CR label reading: an extended-release capsule is not an immediate-release tablet; keep the beads intact" }, "summary": { "zh": "先核对 COREG CR、磷酸卡维地洛、缓释胶囊、准确强度和 NDC。标签中的专业转换表需要开方团队结合年龄、头晕、低血压和晕厥风险执行，网页不会据此给出个人换算。", "en": "Check COREG CR, carvedilol phosphate, extended-release capsule, exact strength and NDC. The label's professional conversion table requires prescriber oversight with age, dizziness, hypotension and syncope risk; the site does not turn it into an individual conversion." }, "checks": [ { "zh": "标签要求随餐服用，不要压碎或咀嚼胶囊。吞咽困难时，可小心打开一整粒，把全部微丸撒在一匙不温热的苹果酱上立即全部吃完；混合物不能储存，未测试撒在其他食物上的吸收。不要分微丸、估算半粒或研碎缓释颗粒。", "en": "The label says to take it with food and not crush or chew the capsule. For swallowing difficulty, one whole capsule may be carefully opened and all beads sprinkled over a spoonful of applesauce that is not warm, then consumed immediately in its entirety. Do not store the mixture; absorption on other foods has not been tested. Do not divide, estimate half a capsule or grind the extended-release beads." }, { "zh": "COREG 是卡维地洛普通片，COREG CR 是磷酸卡维地洛缓释胶囊。标签虽然提供医务人员使用的转换表，但老年人或低血压、头晕、晕厥风险较高者可能需要不同起始考虑。不要按品牌词根、普通片每日总 mg、CR 胶囊 mg 或服用频次自行换算、叠加、轮换或替换。", "en": "COREG is an immediate-release carvedilol tablet; COREG CR is an extended-release carvedilol phosphate capsule. Although the label contains a clinician conversion table, older people or those at higher risk of hypotension, dizziness or syncope may require a different starting approach. Do not self-convert, combine, alternate or substitute from a brand stem, daily immediate-release milligrams, CR capsule milligrams or frequency." }, { "zh": "不要突然停用。标签提示 β 受体阻滞剂突然停用可能使心绞痛加重，并可能发生心肌梗死或室性心律失常。不要因一次血压或脉搏读数自行停药；胸痛、昏厥、严重气促或其他急性严重表现应立即使用当地急救。", "en": "Do not stop abruptly. The label warns that abrupt beta-blocker withdrawal may worsen angina and may be followed by myocardial infarction or ventricular arrhythmia. Do not stop from one blood-pressure or pulse reading; use local emergency care immediately for chest pain, fainting, severe breathlessness or another acute severe feature." }, { "zh": "脉搏过慢、体位性头晕、晕厥、低血压、体重或水肿快速变化需要及时联系治疗团队。标签显示，65 岁以上从最高剂量普通片切换到最高剂量 CR 的试验组，头晕、低血压或晕厥合并发生率更高；这正是不能让网页自动换算的原因。", "en": "A slow pulse, postural dizziness, fainting, hypotension or rapid change in weight or swelling requires prompt contact with the care team. The label reports a higher combined rate of dizziness, hypotension or syncope in people over 65 switched from the highest immediate-release dose to the highest CR dose; this is why a website must not automate conversion." }, { "zh": "把地高辛、可乐定、胺碘酮、氟西汀/帕罗西汀、维拉帕米/地尔硫卓、其他 β 受体阻滞剂、降糖药和全部非处方药/补充剂一起核对。标签提示心率、传导、低血压、地高辛浓度、低血糖警示被掩盖等边界；不要自行错开或先停其中一种。", "en": "Review digoxin, clonidine, amiodarone, fluoxetine/paroxetine, verapamil/diltiazem, another beta blocker, glucose-lowering medicines and all OTC/supplement products together. The label flags heart rate, conduction, hypotension, digoxin concentration and masking of hypoglycaemia warnings; do not self-separate or decide which medicine to stop first." } ], "source": { "id": "src_4455fd9a0a218ffe", "label": "DailyMed（NLM）：COREG CR 磷酸卡维地洛缓释胶囊当前美国公开标签（SPL v3；2025-04-25 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d3625d78-6eb6-41fe-8f6f-664965c104c4", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "磷酸卡维地洛怎样起作用：体内释放卡维地洛，兼有 α1 与非选择性 β 阻断", "en": "How carvedilol phosphate works: it provides carvedilol with alpha-1 and nonselective beta blockade" }, "summary": { "zh": "当前标签说明卡维地洛具有 α1 阻断和非选择性 β 肾上腺素能阻断活性。机制有助于理解为什么心率、血压、传导、体液状态、呼吸和血糖需要一起核对，但不能产生个人剂量、转换表或停换药方案。", "en": "The current label describes carvedilol as having alpha-1 blocking and nonselective beta-adrenergic blocking activity. This helps explain why heart rate, blood pressure, conduction, fluid status, breathing and glucose need joint review, but it cannot produce an individual dose, conversion table or stop/switch plan." }, "checks": [ { "zh": "缓释设计改变药物释放过程，同一活性部分不等于 COREG 普通片与 COREG CR 胶囊可以毫克对毫克替换。", "en": "Extended release changes the delivery process; a shared active moiety does not make COREG immediate-release tablets and COREG CR capsules milligram-for-milligram substitutes." }, { "zh": "标签列 CYP2D6、CYP2C9 和 P-gp 相关相互作用线索；基因或代谢酶名词不是自行调整、停用精神科药或默认进行全基因组检测的依据。", "en": "The label provides CYP2D6, CYP2C9 and P-gp interaction cues. A gene or enzyme name is not a basis for self-adjustment, stopping psychiatric medicine or default whole-genome testing." }, { "zh": "完整药单和实际药盒比单独看一次心率、血压或商品名更重要。任何调整都应由熟悉病情的医生和药师结合症状、监测、年龄及肝肾功能判断。", "en": "The complete medicine list and actual packs matter more than one heart-rate or blood-pressure reading or a brand name. Any change belongs with clinicians and pharmacists who can review symptoms, monitoring, age and liver/kidney function." } ], "source": { "id": "src_4455fd9a0a218ffe", "label": "DailyMed（NLM）：COREG CR 磷酸卡维地洛缓释胶囊当前美国公开标签（SPL v3；2025-04-25 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d3625d78-6eb6-41fe-8f6f-664965c104c4", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "COREG CR", "generic": "磷酸卡维地洛缓释胶囊", "dosageFormClass": "磷酸卡维地洛口服缓释胶囊：10 mg、20 mg、40 mg、80 mg；不是 COREG 卡维地洛普通片的另一种包装" }, "labelSource": { "id": "src_4455fd9a0a218ffe", "label": "DailyMed（NLM）：COREG CR 磷酸卡维地洛缓释胶囊当前美国公开标签（SPL v3；2025-04-25 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d3625d78-6eb6-41fe-8f6f-664965c104c4", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "productRoutes": [ { "source": { "id": "src_4455fd9a0a218ffe", "label": "DailyMed（NLM）：COREG CR 磷酸卡维地洛缓释胶囊当前美国公开标签（SPL v3；2025-04-25 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d3625d78-6eb6-41fe-8f6f-664965c104c4", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-29", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_10e511bf83430e3b", "label": "FDA Orange Book：COREG CR NDA 022012 的 10／20／40／80 mg 均列为处方 RLD，RS 均为 No（数据复核日 2026-08-30）", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-08-29", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-29", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "COREG CR 是磷酸卡维地洛缓释胶囊，不是 COREG 卡维地洛普通片。两个产品虽共享品牌词根和卡维地洛活性部分，但剂型、标示成分形式、释放方式和毫克数字不能自行一对一换算。当前标签要求随餐服用，不能压碎或咀嚼；吞咽困难时只允许按标签打开整粒，把全部微丸撒在一匙不温热的苹果酱上立即全部吃完，不能只吃一部分或储存。老人、低脉搏、头晕/晕厥、糖尿病和多种减慢心率药同用时应优先核对。网页不生成个人转换表、粒数、频次、停药或补服方案。", "history": "FDA Drugs@FDA 数据记录 NDA 022012 原始申请于 2006-10-20 批准。当前 DailyMed 标签于 2025-04-25 生效，并列四个 30 粒瓶装 NDC。标签中的 Initial U.S. Approval: 1995 是卡维地洛产品历史，不是 COREG CR 在 1995 年获批。COREG 普通片另属 NDA 020297 和即释片档案，两个页面必须分开阅读。", "sourceDocuments": [ { "id": "src_4455fd9a0a218ffe", "label": "DailyMed（NLM）：COREG CR 磷酸卡维地洛缓释胶囊当前美国公开标签（SPL v3；2025-04-25 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d3625d78-6eb6-41fe-8f6f-664965c104c4", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, { "id": "src_10e511bf83430e3b", "label": "FDA Orange Book：COREG CR NDA 022012 的 10／20／40／80 mg 均列为处方 RLD，RS 均为 No（数据复核日 2026-08-30）", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, { "id": "src_25a85c5faf3af303", "label": "FDA Drugs@FDA：COREG CR NDA 022012 产品与批准记录（原始申请 2006-10-20 批准）", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=022012", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "approval_history", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" } ], "applicationNumber": "FDA NDA 022012（COREG CR／carvedilol phosphate extended-release capsules）", "approvalTimeline": [ { "date": "2006-10-20", "title": { "zh": "FDA 批准 COREG CR 原始申请", "en": "FDA approved the original COREG CR application" }, "detail": { "zh": "Drugs@FDA 数据记录 NDA 022012 原始申请批准；当前 Orange Book 仍列四个处方 RLD 规格，RS 均为 No。", "en": "Drugs@FDA data record approval of the original NDA 022012 application; the current Orange Book still lists four prescription RLD strengths, none designated RS." }, "source": { "id": "src_25a85c5faf3af303", "label": "FDA Drugs@FDA：COREG CR NDA 022012 产品与批准记录（原始申请 2006-10-20 批准）", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=022012", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "approval_history", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" } }, { "date": "2025-04-25", "title": { "zh": "当前 DailyMed 标签生效", "en": "Current DailyMed label became effective" }, "detail": { "zh": "SPL v3 列出四个规格、四个 30 粒瓶装 NDC、随餐要求、完整微丸苹果酱给药规则和更新的安全信息。", "en": "SPL v3 lists four strengths, four 30-capsule bottle NDCs, the with-food requirement, the all-beads applesauce option and updated safety information." }, "source": { "id": "src_4455fd9a0a218ffe", "label": "DailyMed（NLM）：COREG CR 磷酸卡维地洛缓释胶囊当前美国公开标签（SPL v3；2025-04-25 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d3625d78-6eb6-41fe-8f6f-664965c104c4", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } }, { "date": "2026-08-30", "title": { "zh": "Orange Book 产品身份复核", "en": "Orange Book product identity reviewed" }, "detail": { "zh": "四个规格均为处方 RLD，RS 均为 No；该字段不表示个人首选或可自行换药。", "en": "All four strengths are prescription RLD products and none is the RS; these fields do not establish individual preference or self-switching." }, "source": { "id": "src_10e511bf83430e3b", "label": "FDA Orange Book：COREG CR NDA 022012 的 10／20／40／80 mg 均列为处方 RLD，RS 均为 No（数据复核日 2026-08-30）", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "四个处方 RLD 规格当前列示；四个准确 30 粒瓶装面板", "en": "Four prescription RLD strengths currently listed; four exact 30-capsule bottle panels" }, "detail": { "zh": "NDC 80725-383-13、-385-13、-387-13、-388-13 分别对应 10、20、40、80 mg。监管在册和图像不证明药房实时库存、购买资格或个人适用性。", "en": "NDCs 80725-383-13, -385-13, -387-13 and -388-13 correspond to 10, 20, 40 and 80 mg. Regulatory listing and images do not establish live pharmacy stock, purchasing eligibility or individual suitability." } }, { "market": { "zh": "中国大陆及其他市场", "en": "Mainland China and other markets" }, "status": { "zh": "待逐项建立现行产品记录", "en": "Current product record not established" }, "detail": { "zh": "不从美国品牌、NDA、胶囊颜色或 mg 数字推定当地批准、商品名、供应、原研/参比关系或可替代性。", "en": "No local approval, brand, supply, originator/reference relationship or interchangeability is inferred from a U.S. brand, NDA, capsule colour or milligram figure." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "COREG CR 胶囊可以打开吃一半吗？", "en": "Can a COREG CR capsule be opened and half taken?" }, "answer": { "zh": "不能。当前标签只允许为吞咽困难打开一整粒，并把全部微丸撒在一匙不温热的苹果酱上立即全部吃完；不能分半、估算颗粒、压碎、咀嚼或储存。", "en": "No. The current label only allows opening one whole capsule for swallowing difficulty and sprinkling all beads on a spoonful of applesauce that is not warm for immediate complete consumption. Do not halve, estimate beads, crush, chew or store." } }, { "question": { "zh": "COREG 普通片和 COREG CR 能按毫克直接换吗？", "en": "Can COREG tablets and COREG CR be switched directly by milligrams?" }, "answer": { "zh": "不能自行换。现行标签有供专业人员使用的转换信息，但年龄、头晕、低血压和晕厥风险会改变起始考虑。请带两盒药和完整药单让开方团队核对，网页不提供个人转换表。", "en": "Not by self-direction. The current label includes clinician conversion information, but age and risks of dizziness, hypotension and syncope alter the starting approach. Take both packs and the full medicine list to the prescribing team; the site provides no individual conversion table." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "dosage-forms-are-part-of-medicine-identity", "how-to-read-a-drug-label", "family-medicine-list-for-pharmacist" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/coreg-cr/", "en": "https://origindrug.com/en/drugs/coreg-cr/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "amitiza", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-30", "status": "published_traceable_archive" }, "names": { "brand": "AMITIZA", "generic": "鲁比前列酮", "aliases": [ "Amitiza", "lubiprostone", "鲁比前列酮", "鲁比前列酮胶囊", "ルビプロストン", "lubiprostone capsules", "NDA 021908", "23635-508-60", "23635-524-60", "AMITIZA 8 mcg", "AMITIZA 24 mcg", "pink oval SPI", "orange oval SPI" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "消化系统", "sourceArchiveMarket": "美国：DailyMed 当前标签列出 AMITIZA 8 mcg 粉红色与 24 mcg 橙色软明胶胶囊，均为 60 粒瓶装；FDA Orange Book 将两种规格均列为处方 RLD，并将 24 mcg 列为 RS。中国大陆及其他市场的现行批准、商品名、包装和供应须另行逐项建立，不能从美国品牌或颜色推定。", "dosageFormClass": "鲁比前列酮口服软明胶胶囊：8 mcg 与 24 mcg；必须整粒吞服，不得掰开、剪开、刺破、挤出、咀嚼或目测取半", "dosageFormClassCode": "oral_solid", "route": "口服（完整软明胶胶囊）", "routeCode": "oral", "historicalApprovalEntry": "2006-01-31（美国 24 mcg 初始批准）；2008-04-29（美国 8 mcg 批准）", "archiveSponsorText": "Sucampo Pharma Americas LLC（FDA Orange Book 申请主体）；SpecGx LLC（当前 DailyMed 标签包装方）" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [ "AMITIZA", "Amitiza", "鲁比前列酮胶囊" ], "excludedProductCues": [ "generic lubiprostone capsule", "其他厂牌鲁比前列酮胶囊", "LINZESS", "linaclotide", "MiraLAX", "polyethylene glycol 3350", "DULCOLAX", "bisacodyl", "lactulose", "senna", "magnesium laxatives" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-amitiza-lubiprostone-8mcg-60-capsule-bottle-ndc-2363550860", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国品牌标签（SPL v4；2026-07-10 生效）；准确包装身份，不代表实时库存", "en": "Current U.S. DailyMed brand label (SPL v4; effective 10 Jul 2026); exact pack identity, not real-time stock" }, "dosageForm": { "zh": "AMITIZA 鲁比前列酮口服软明胶胶囊", "en": "AMITIZA lubiprostone oral soft gelatin capsule" }, "route": { "zh": "口服（完整胶囊）", "en": "oral (whole capsule)" }, "routeCodes": [ "oral" ], "productCode": "NDC 23635-508-60", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_capsule", "primaryDisplay": { "zh": "每粒鲁比前列酮 8 mcg；60 粒瓶装", "en": "Lubiprostone 8 mcg per capsule; 60-capsule bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=amitiza-02.jpg&setid=164a2b47-0a52-4bb4-9e71-5342c2e951f4&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "鲁比前列酮", "en": "lubiprostone" }, "value": 8, "unit": "mcg", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒标签标示量；不是个人一次粒数、频率、疗程或加减量指令", "en": "labelled amount per capsule; not an individual's capsule count, frequency, duration or adjustment instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 60, "countUnit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-30", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "current_regulatory_listing_not_live_stock", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 60, "unit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "physicalClues": { "color": { "zh": "粉红色", "en": "pink" }, "shape": { "zh": "椭圆形软明胶胶囊，约 9 mm；胶囊接缝不是可分剂量刻痕", "en": "oval soft gelatin capsule, about 9 mm; the capsule seam is not a dose-dividing score" }, "imprint": "SPI", "scoreStatus": "capsule_not_scored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_a5fc2a799de46a3d", "label": "DailyMed（NLM）：AMITIZA 鲁比前列酮胶囊当前美国品牌标签（SPL v4；2026-07-10 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=164a2b47-0a52-4bb4-9e71-5342c2e951f4", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-amitiza-lubiprostone-24mcg-60-capsule-bottle-ndc-2363552460", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国品牌标签（SPL v4；2026-07-10 生效）；准确包装身份，不代表实时库存", "en": "Current U.S. DailyMed brand label (SPL v4; effective 10 Jul 2026); exact pack identity, not real-time stock" }, "dosageForm": { "zh": "AMITIZA 鲁比前列酮口服软明胶胶囊", "en": "AMITIZA lubiprostone oral soft gelatin capsule" }, "route": { "zh": "口服（完整胶囊）", "en": "oral (whole capsule)" }, "routeCodes": [ "oral" ], "productCode": "NDC 23635-524-60", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_capsule", "primaryDisplay": { "zh": "每粒鲁比前列酮 24 mcg；60 粒瓶装", "en": "Lubiprostone 24 mcg per capsule; 60-capsule bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=amitiza-03.jpg&setid=164a2b47-0a52-4bb4-9e71-5342c2e951f4&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "鲁比前列酮", "en": "lubiprostone" }, "value": 24, "unit": "mcg", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒标签标示量；不是个人一次粒数、频率、疗程或加减量指令", "en": "labelled amount per capsule; not an individual's capsule count, frequency, duration or adjustment instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 60, "countUnit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-30", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "current_regulatory_listing_not_live_stock", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 60, "unit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "physicalClues": { "color": { "zh": "橙色", "en": "orange" }, "shape": { "zh": "椭圆形软明胶胶囊，约 9 mm；胶囊接缝不是可分剂量刻痕", "en": "oval soft gelatin capsule, about 9 mm; the capsule seam is not a dose-dividing score" }, "imprint": "SPI", "scoreStatus": "capsule_not_scored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_a5fc2a799de46a3d", "label": "DailyMed（NLM）：AMITIZA 鲁比前列酮胶囊当前美国品牌标签（SPL v4；2026-07-10 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=164a2b47-0a52-4bb4-9e71-5342c2e951f4", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-amitiza-lubiprostone-8mcg-60-capsule-bottle-ndc-2363550860", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=amitiza-02.jpg&setid=164a2b47-0a52-4bb4-9e71-5342c2e951f4&type=img", "alt": "AMITIZA 鲁比前列酮 8 mcg、NDC 23635-508-60、60 粒瓶装的美国 DailyMed 官方标签展示面", "archiveMarket": "美国", "labelVersion": "DailyMed SPL v4；2026-07-10 生效", "presentation": "AMITIZA 每粒鲁比前列酮 8 mcg，粉红色椭圆形软明胶胶囊，印有 SPI，NDC 23635-508-60，60 粒瓶装。", "notice": "此图只对应当前美国标签中的 8 mcg、NDC 23635-508-60、60 粒瓶装；不代表 24 mcg、其他厂牌、其他市场包装、实时库存或个人粒数，不用于鉴定真伪。", "source": { "id": "src_a5fc2a799de46a3d", "label": "DailyMed（NLM）：AMITIZA 鲁比前列酮胶囊当前美国品牌标签（SPL v4；2026-07-10 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=164a2b47-0a52-4bb4-9e71-5342c2e951f4", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "AMITIZA 说明书放大阅读：微克、整粒软胶囊、腹泻与低血压", "en": "AMITIZA label reading: micrograms, whole softgel, diarrhoea and low blood pressure" }, "summary": { "zh": "先核对 AMITIZA、鲁比前列酮、8 或 24 mcg、粉红／橙色、SPI 印字和准确 NDC。不要把微克看成毫克，也不要把 60 粒瓶装误当一次使用数量。", "en": "Check AMITIZA, lubiprostone, 8 or 24 mcg, pink/orange colour, SPI imprint and the exact NDC. Do not read micrograms as milligrams or mistake a 60-capsule bottle count for an amount to take." }, "checks": [ { "zh": "8 mcg 与 24 mcg 是每粒强度；1 mg 等于 1,000 mcg 只是单位关系。不要按颜色、数字或既往药盒自行改规格、加粒数或轮换。", "en": "8 mcg and 24 mcg are strengths per capsule; 1 mg equals 1,000 mcg as a unit relationship only. Do not self-change strength, capsule count or alternate products from colour, numbers or a previous pack." }, { "zh": "当前标签要求整粒吞服，不得掰开或咀嚼。软胶囊没有可取半的刻痕；不要剪开、刺破、挤出、吸取或保存部分内容物。吞咽困难应先联系药师或开方团队寻找准确替代路径。", "en": "The current label says to swallow capsules whole and not break apart or chew. A softgel has no score for taking half; do not cut, puncture, squeeze out, measure or store part of its contents. For swallowing difficulty, first contact a pharmacist or prescribing team for an exact alternative route." }, { "zh": "标签要求与食物和水同服，并提示食物可能减轻恶心。网页不把这条转成个人时间表；持续恶心、呕吐、无法进食饮水或症状加重时应联系治疗团队。", "en": "The label says to take it with food and water and notes that food may reduce nausea. The site does not turn this into a personal timetable; contact the care team for persistent nausea, vomiting, inability to eat or drink, or worsening symptoms." }, { "zh": "标签提示严重腹泻时不要继续使用并联系医务人员；腹泻或呕吐可能伴随晕厥和低血压。老人、近期脱水或同时使用降压药者出现明显头晕、站立不稳或晕厥，应尽快取得专业评估；意识异常、严重气促或其他急性严重表现应立即使用当地急救。", "en": "The label says not to use it during severe diarrhoea and to contact a healthcare provider; diarrhoea or vomiting may occur with syncope and hypotension. Older people, those recently dehydrated or taking blood-pressure-lowering medicines should obtain prompt assessment for marked dizziness, unsteadiness or fainting; use local emergency care immediately for altered consciousness, severe breathlessness or another acute severe feature." }, { "zh": "已知或怀疑机械性胃肠梗阻属于禁忌边界，不是靠多吃泻药处理的普通便秘。明显腹胀并持续加重、反复呕吐、剧烈腹痛、不能排气排便或其他急性危险表现应立即就医。", "en": "Known or suspected mechanical gastrointestinal obstruction is a contraindication boundary, not ordinary constipation to treat by adding laxatives. Seek urgent care for progressively severe distension, repeated vomiting, severe abdominal pain, inability to pass stool or gas, or another acute warning feature." }, { "zh": "把 MiraLAX／聚乙二醇、乳果糖、比沙可啶、番泻叶、含镁泻药、其他处方泻药、降压药、阿片类与补充剂列在同一张药单上。不要自行叠加、轮换或停掉其中一种；标签还提示二苯庚烷类阿片（如美沙酮）可能降低鲁比前列酮作用。", "en": "Put MiraLAX/polyethylene glycol, lactulose, bisacodyl, senna, magnesium laxatives, other prescription laxatives, blood-pressure medicines, opioids and supplements on one list. Do not self-combine, alternate or stop one; the label also notes that diphenylheptane opioids such as methadone may reduce lubiprostone's effect." } ], "source": { "id": "src_a5fc2a799de46a3d", "label": "DailyMed（NLM）：AMITIZA 鲁比前列酮胶囊当前美国品牌标签（SPL v4；2026-07-10 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=164a2b47-0a52-4bb4-9e71-5342c2e951f4", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "鲁比前列酮怎样起作用：局部激活氯离子通道，增加肠腔液体", "en": "How lubiprostone works: local chloride-channel activation increases intestinal fluid" }, "summary": { "zh": "当前标签将鲁比前列酮描述为局部作用的氯离子通道激活剂，可激活肠上皮顶端膜的 ClC-2 通道并增加富含氯离子的肠液分泌。机制帮助理解软化和推进边界，但不能诊断便秘原因或生成个人方案。", "en": "The current label describes lubiprostone as a locally acting chloride-channel activator that activates apical ClC-2 channels and increases chloride-rich intestinal fluid secretion. The mechanism helps explain the softening and transit boundary but cannot diagnose the cause of constipation or generate an individual regimen." }, "checks": [ { "zh": "AMITIZA 与 LINZESS、MiraLAX、DULCOLAX、乳果糖或番泻叶并非同一种药；不能从‘都通便’推导叠加、轮换或毫克／微克换算。", "en": "AMITIZA is not the same medicine as LINZESS, MiraLAX, DULCOLAX, lactulose or senna. A shared constipation context does not justify combining, alternating or milligram/microgram conversion." }, { "zh": "药物机制不能排除梗阻、出血、感染、代谢异常或其他病因。新出现或明显改变的排便问题，尤其伴随危险表现，应由专业人员评估。", "en": "A mechanism cannot rule out obstruction, bleeding, infection, metabolic disease or another cause. New or markedly changed bowel symptoms, especially with warning features, require professional assessment." }, { "zh": "评价效果和不适时应同时记录实际药盒、开始时间、饮水与进食变化、其他泻药、阿片类、降压药、腹泻、头晕和跌倒，而不是只记录‘便秘好没好’。", "en": "When reviewing benefit and harm, record the actual pack, start date, changes in intake, other laxatives, opioids, blood-pressure medicines, diarrhoea, dizziness and falls—not only whether constipation improved." } ], "source": { "id": "src_a5fc2a799de46a3d", "label": "DailyMed（NLM）：AMITIZA 鲁比前列酮胶囊当前美国品牌标签（SPL v4；2026-07-10 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=164a2b47-0a52-4bb4-9e71-5342c2e951f4", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "AMITIZA", "generic": "鲁比前列酮", "dosageFormClass": "鲁比前列酮口服软明胶胶囊：8 mcg 与 24 mcg；必须整粒吞服，不得掰开、剪开、刺破、挤出、咀嚼或目测取半" }, "labelSource": { "id": "src_a5fc2a799de46a3d", "label": "DailyMed（NLM）：AMITIZA 鲁比前列酮胶囊当前美国品牌标签（SPL v4；2026-07-10 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=164a2b47-0a52-4bb4-9e71-5342c2e951f4", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "productRoutes": [ { "source": { "id": "src_a5fc2a799de46a3d", "label": "DailyMed（NLM）：AMITIZA 鲁比前列酮胶囊当前美国品牌标签（SPL v4；2026-07-10 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=164a2b47-0a52-4bb4-9e71-5342c2e951f4", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-30", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_10e511bf83430e3b", "label": "FDA Orange Book：AMITIZA NDA 021908 的 24 mcg 与 8 mcg 均列为处方 RLD；24 mcg 同时为 RS（数据复核日 2026-08-30）", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-08-29", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-30", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "AMITIZA 是鲁比前列酮软明胶胶囊。普通人先看四件事：8 和 24 的单位是 mcg（微克），60 是每瓶粒数；软胶囊必须整粒吞服，不能剪开挤出一半；标签要求与食物和水同服；严重腹泻、呕吐、头晕、晕厥、低血压或呼吸困难需要及时联系专业人员。老人或同时使用降压药、其他泻药、阿片类药物时，更应把完整药单与实际药盒一起核对。网页不生成个人粒数、频次、疗程、加量、减量或换药方案。", "history": "FDA Orange Book 记录 AMITIZA 24 mcg 于 2006-01-31 批准，8 mcg 于 2008-04-29 批准。当前 DailyMed 标签 SPL v4 于 2026-07-10 生效，列出两个准确 NDC 和软胶囊外观。历史批准节点不代表任何地区当前有货，也不能代替现行处方、当地说明书和个人用药评估。", "sourceDocuments": [ { "id": "src_a5fc2a799de46a3d", "label": "DailyMed（NLM）：AMITIZA 鲁比前列酮胶囊当前美国品牌标签（SPL v4；2026-07-10 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=164a2b47-0a52-4bb4-9e71-5342c2e951f4", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, { "id": "src_10e511bf83430e3b", "label": "FDA Orange Book：AMITIZA NDA 021908 的 24 mcg 与 8 mcg 均列为处方 RLD；24 mcg 同时为 RS（数据复核日 2026-08-30）", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, { "id": "src_a1347c842989dea8", "label": "FDA Drugs@FDA：AMITIZA NDA 021908 产品与批准记录", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=021908", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_database_record", "documentKind": "approval_history", "market": "US", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" } ], "applicationNumber": "FDA NDA 021908（AMITIZA／lubiprostone capsules）", "approvalTimeline": [ { "date": "2006-01-31", "title": { "zh": "FDA 批准 AMITIZA 24 mcg", "en": "FDA approved AMITIZA 24 mcg" }, "detail": { "zh": "Orange Book 当前产品 001 记录 24 mcg 处方胶囊为 RLD 与 RS。", "en": "Current Orange Book product 001 records the 24 mcg prescription capsule as both RLD and RS." }, "source": { "id": "src_10e511bf83430e3b", "label": "FDA Orange Book：AMITIZA NDA 021908 的 24 mcg 与 8 mcg 均列为处方 RLD；24 mcg 同时为 RS（数据复核日 2026-08-30）", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } }, { "date": "2008-04-29", "title": { "zh": "FDA 批准 AMITIZA 8 mcg", "en": "FDA approved AMITIZA 8 mcg" }, "detail": { "zh": "Orange Book 当前产品 002 记录 8 mcg 处方胶囊为 RLD，RS 为 No。", "en": "Current Orange Book product 002 records the 8 mcg prescription capsule as RLD with RS marked No." }, "source": { "id": "src_10e511bf83430e3b", "label": "FDA Orange Book：AMITIZA NDA 021908 的 24 mcg 与 8 mcg 均列为处方 RLD；24 mcg 同时为 RS（数据复核日 2026-08-30）", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } }, { "date": "2026-07-10", "title": { "zh": "当前 DailyMed 标签生效", "en": "Current DailyMed label became effective" }, "detail": { "zh": "SPL v4 列出两个准确 NDC、60 粒瓶装、SPI 印字、整粒吞服规则及当前安全信息。", "en": "SPL v4 lists two exact NDCs, 60-capsule bottles, SPI imprint, whole-capsule rule and current safety information." }, "source": { "id": "src_a5fc2a799de46a3d", "label": "DailyMed（NLM）：AMITIZA 鲁比前列酮胶囊当前美国品牌标签（SPL v4；2026-07-10 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=164a2b47-0a52-4bb4-9e71-5342c2e951f4", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "两种处方 RLD 规格当前列示；两个准确 60 粒瓶装面板", "en": "Two prescription RLD strengths currently listed; two exact 60-capsule bottle panels" }, "detail": { "zh": "NDC 23635-508-60 对应 8 mcg 粉红色软胶囊；NDC 23635-524-60 对应 24 mcg 橙色软胶囊。监管在册和图像不证明药房实时库存、购买资格或个人适用性。", "en": "NDC 23635-508-60 is the 8 mcg pink softgel; NDC 23635-524-60 is the 24 mcg orange softgel. Regulatory listing and images do not establish live pharmacy stock, purchasing eligibility or individual suitability." } }, { "market": { "zh": "中国大陆及其他市场", "en": "Mainland China and other markets" }, "status": { "zh": "待逐项建立现行产品记录", "en": "Current product record not established" }, "detail": { "zh": "不从美国品牌、NDA、软胶囊颜色或微克数字推定当地批准、商品名、供应、原研／参比关系或可替代性。", "en": "No local approval, brand, supply, originator/reference relationship or interchangeability is inferred from a U.S. brand, NDA, softgel colour or microgram figure." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "AMITIZA 软胶囊可以剪开吃一半吗？", "en": "Can an AMITIZA softgel be cut and half taken?" }, "answer": { "zh": "不能。当前标签要求整粒吞服，不得掰开或咀嚼；也不要刺破、挤出或目测取半。吞咽困难请让药师或开方团队核对可用的准确替代路径。", "en": "No. The current label says to swallow it whole and not break apart or chew; do not puncture, squeeze out or estimate half. Ask a pharmacist or prescribing team to check an exact alternative route for swallowing difficulty." } }, { "question": { "zh": "8 mcg 和 24 mcg 可以自己换吗？", "en": "Can I switch between 8 mcg and 24 mcg myself?" }, "answer": { "zh": "不能。它们是每粒不同强度，适用边界和个人方案须由熟悉病情的专业人员按当前说明书核对。网页不提供换算、加粒或减粒指令。", "en": "No. They are different strengths per capsule; the relevant use boundary and individual plan require a professional who knows the clinical context and current label. The site provides no conversion or capsule-count adjustment." } }, { "question": { "zh": "还能同时用 MiraLAX、乳果糖或比沙可啶吗？", "en": "Can MiraLAX, lactulose or bisacodyl be used at the same time?" }, "answer": { "zh": "网页不能据此给个人合用结论。请把所有处方药、非处方泻药、补充剂、排便记录、腹泻和头晕情况交给医生或药师核对，避免重复作用与脱水。", "en": "The site cannot make an individual co-use decision. Give the clinician or pharmacist every prescription medicine, OTC laxative, supplement, bowel record, diarrhoea and dizziness detail to review for duplication and dehydration." } }, { "question": { "zh": "老人吃降压药后又腹泻、头晕怎么办？", "en": "What if an older person taking blood-pressure medicine develops diarrhoea and dizziness?" }, "answer": { "zh": "应尽快联系治疗团队。标签提示腹泻或呕吐可伴随晕厥和低血压，降压药可能增加风险；明显站立不稳、晕厥、意识异常或严重气促应立即使用当地急救。", "en": "Contact the care team promptly. The label notes syncope and hypotension with diarrhoea or vomiting, and blood-pressure-lowering medicines may increase risk. Use local emergency care immediately for marked unsteadiness, fainting, altered consciousness or severe breathlessness." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "dosage-forms-are-part-of-medicine-identity", "family-medicine-list-for-pharmacist", "medicine-review-for-older-adults" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/amitiza/", "en": "https://origindrug.com/en/drugs/amitiza/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "atacand", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-09-02", "status": "published_traceable_archive" }, "names": { "brand": "ATACAND", "generic": "坎地沙坦酯", "aliases": [ "Atacand", "candesartan cilexetil", "candesartan", "坎地沙坦酯", "坎地沙坦", "坎地沙坦酯片", "必洛斯", "candesartan cilexetil tablets", "NDA 020838", "62559-640-30", "62559-641-30", "62559-642-30", "62559-643-30", "ATACAND 4 mg", "ATACAND 8 mg", "ATACAND 16 mg", "ATACAND 32 mg" ], "marketBrandNames": [ { "name": "ATACAND", "market": { "zh": "美国", "en": "United States" }, "evidenceStatus": "current_regulatory_record", "note": { "zh": "四个处方 RLD 规格；32 mg 同时为 RS。", "en": "Four prescription RLD strengths; 32 mg is also the RS." }, "source": { "id": "src_10e511bf83430e3b", "label": "FDA Orange Book：ATACAND NDA 020838 四个口服片规格均为 RLD，32 mg 同时为 RS（数据 2026-08-26 获取）", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } }, { "name": "ATACAND", "market": { "zh": "加拿大", "en": "Canada" }, "evidenceStatus": "current_regulatory_record", "note": { "zh": "Health Canada Marketed 数据列出四个坎地沙坦酯 DIN；不外推其他市场供应。", "en": "Health Canada marketed data list four candesartan cilexetil DINs; this does not project supply to another market." }, "source": { "id": "src_f569b57eee87a182", "label": "Health Canada：药品产品数据库（DPD）当前访问页；在库内核对 ATACAND 与四个 DIN", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_lookup_entry", "documentKind": "regulatory_lookup", "market": "CA", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-09-13", "reviewedAt": "2026-09-13" } } ], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "心血管", "sourceArchiveMarket": "美国 DailyMed 当前品牌标签列出 4、8、16、32 mg 四种普通口服片和六个瓶装身份：4/8 mg 各有 30 片瓶，16/32 mg 各有 30 与 90 片瓶；当前主展示图只逐一对应四个 30 片瓶，两个 90 片瓶保留为官方文字身份，不借用图片。FDA Orange Book 将 NDA 020838 四规格均列为处方 RLD，并将 32 mg 列为 RS。Health Canada 的 2026-08-26 Marketed 数据中有四个 ATACAND 坎地沙坦酯 DIN。监管记录、包装图和具体药房实时库存是不同证据层级。", "dosageFormClass": "坎地沙坦酯普通口服片：4 mg、8 mg、16 mg、32 mg；本页不并入 ATACAND HCT／PLUS 复方，也不把有刻痕解释为自行分片许可", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "1998-06-04（FDA NDA 020838 四规格批准日期）", "archiveSponsorText": "ANI Pharmaceuticals, Inc.（当前美国申请主体）；AstraZeneca 品牌许可历史；加拿大当前记录为 CHEPLAPHARM Arzneimittel GmbH" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [ "ATACAND", "Atacand", "坎地沙坦酯片" ], "excludedProductCues": [ "ATACAND HCT", "ATACAND PLUS", "candesartan cilexetil and hydrochlorothiazide", "坎地沙坦酯氢氯噻嗪" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-atacand-candesartan-cilexetil-4mg-30-tablet-bottle-ndc-6255964030", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国品牌标签（SPL v5；2025-07 修订）", "en": "Current U.S. DailyMed brand label (SPL v5; revised Jul 2025)" }, "dosageForm": { "zh": "ATACAND 坎地沙坦酯普通口服片", "en": "ATACAND candesartan cilexetil immediate-release oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 62559-640-30 / NDA 020838 Product 001", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片坎地沙坦酯 4 mg；30 片瓶装", "en": "4 mg candesartan cilexetil per tablet; 30-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=Label-4mg.jpg&setid=94a59260-d2b6-464a-b5b9-bbc599e57e10", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "坎地沙坦酯", "en": "candesartan cilexetil" }, "value": 4, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、分片许可或与另一种 ARB 的换算值", "en": "labelled amount per tablet; not an individual tablet count, splitting permission or conversion to another ARB" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-02", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "current_regulatory_listing_not_live_stock", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 30, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "白色至类白色", "en": "white to off-white" }, "shape": { "zh": "圆形、双凸、有刻痕，约 7 mm；刻痕只作身份核对", "en": "round, biconvex and scored, approximately 7 mm; the score is an identity clue only" }, "imprint": "ACF / 004", "scoreStatus": "scored_status_not_a_split_instruction", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_0b9f506f7316675b", "label": "DailyMed（NLM）：ATACAND 坎地沙坦酯当前美国品牌标签（SPL v5；2025-07 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=94a59260-d2b6-464a-b5b9-bbc599e57e10", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-atacand-candesartan-cilexetil-8mg-30-tablet-bottle-ndc-6255964130", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国品牌标签（SPL v5；2025-07 修订）", "en": "Current U.S. DailyMed brand label (SPL v5; revised Jul 2025)" }, "dosageForm": { "zh": "ATACAND 坎地沙坦酯普通口服片", "en": "ATACAND candesartan cilexetil immediate-release oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 62559-641-30 / NDA 020838 Product 002", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片坎地沙坦酯 8 mg；30 片瓶装", "en": "8 mg candesartan cilexetil per tablet; 30-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=Label-8mg.jpg&setid=94a59260-d2b6-464a-b5b9-bbc599e57e10", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "坎地沙坦酯", "en": "candesartan cilexetil" }, "value": 8, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、分片许可或与另一种 ARB 的换算值", "en": "labelled amount per tablet; not an individual tablet count, splitting permission or conversion to another ARB" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-02", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "current_regulatory_listing_not_live_stock", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 30, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "浅粉红色", "en": "light pink" }, "shape": { "zh": "圆形、双凸、有刻痕，约 7 mm；刻痕只作身份核对", "en": "round, biconvex and scored, approximately 7 mm; the score is an identity clue only" }, "imprint": "ACG / 008", "scoreStatus": "scored_status_not_a_split_instruction", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_0b9f506f7316675b", "label": "DailyMed（NLM）：ATACAND 坎地沙坦酯当前美国品牌标签（SPL v5；2025-07 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=94a59260-d2b6-464a-b5b9-bbc599e57e10", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-atacand-candesartan-cilexetil-16mg-30-tablet-bottle-ndc-6255964230", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国品牌标签（SPL v5；2025-07 修订）", "en": "Current U.S. DailyMed brand label (SPL v5; revised Jul 2025)" }, "dosageForm": { "zh": "ATACAND 坎地沙坦酯普通口服片", "en": "ATACAND candesartan cilexetil immediate-release oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 62559-642-30 / NDA 020838 Product 003", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片坎地沙坦酯 16 mg；30 片瓶装", "en": "16 mg candesartan cilexetil per tablet; 30-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=Label-16mg.jpg&setid=94a59260-d2b6-464a-b5b9-bbc599e57e10", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "坎地沙坦酯", "en": "candesartan cilexetil" }, "value": 16, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、分片许可或与另一种 ARB 的换算值", "en": "labelled amount per tablet; not an individual tablet count, splitting permission or conversion to another ARB" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-02", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "current_regulatory_listing_not_live_stock", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 30, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "粉红色", "en": "pink" }, "shape": { "zh": "圆形、双凸、有刻痕，约 7 mm；刻痕只作身份核对", "en": "round, biconvex and scored, approximately 7 mm; the score is an identity clue only" }, "imprint": "ACH / 016", "scoreStatus": "scored_status_not_a_split_instruction", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_0b9f506f7316675b", "label": "DailyMed（NLM）：ATACAND 坎地沙坦酯当前美国品牌标签（SPL v5；2025-07 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=94a59260-d2b6-464a-b5b9-bbc599e57e10", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-atacand-candesartan-cilexetil-16mg-90-tablet-bottle-ndc-6255964290", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国品牌标签（SPL v5；2025-07 修订）", "en": "Current U.S. DailyMed brand label (SPL v5; revised Jul 2025)" }, "dosageForm": { "zh": "ATACAND 坎地沙坦酯普通口服片", "en": "ATACAND candesartan cilexetil immediate-release oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 62559-642-90 / NDA 020838 Product 003", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片坎地沙坦酯 16 mg；90 片瓶装", "en": "16 mg candesartan cilexetil per tablet; 90-tablet bottle" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "坎地沙坦酯", "en": "candesartan cilexetil" }, "value": 16, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、分片许可或与另一种 ARB 的换算值", "en": "labelled amount per tablet; not an individual tablet count, splitting permission or conversion to another ARB" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 90, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-02", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "current_regulatory_listing_not_live_stock", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 90, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "粉红色", "en": "pink" }, "shape": { "zh": "圆形、双凸、有刻痕，约 7 mm；刻痕只作身份核对", "en": "round, biconvex and scored, approximately 7 mm; the score is an identity clue only" }, "imprint": "ACH / 016", "scoreStatus": "scored_status_not_a_split_instruction", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_0b9f506f7316675b", "label": "DailyMed（NLM）：ATACAND 坎地沙坦酯当前美国品牌标签（SPL v5；2025-07 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=94a59260-d2b6-464a-b5b9-bbc599e57e10", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-atacand-candesartan-cilexetil-32mg-30-tablet-bottle-ndc-6255964330", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国品牌标签（SPL v5；2025-07 修订）", "en": "Current U.S. DailyMed brand label (SPL v5; revised Jul 2025)" }, "dosageForm": { "zh": "ATACAND 坎地沙坦酯普通口服片", "en": "ATACAND candesartan cilexetil immediate-release oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 62559-643-30 / NDA 020838 Product 004", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片坎地沙坦酯 32 mg；30 片瓶装；FDA RS", "en": "32 mg candesartan cilexetil per tablet; 30-tablet bottle; FDA RS" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=Label-32mg.jpg&setid=94a59260-d2b6-464a-b5b9-bbc599e57e10", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "坎地沙坦酯", "en": "candesartan cilexetil" }, "value": 32, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、分片许可或与另一种 ARB 的换算值", "en": "labelled amount per tablet; not an individual tablet count, splitting permission or conversion to another ARB" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-02", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "current_regulatory_listing_not_live_stock", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 30, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "粉红色", "en": "pink" }, "shape": { "zh": "圆形、双凸、有刻痕，约 10 mm；刻痕只作身份核对", "en": "round, biconvex and scored, approximately 10 mm; the score is an identity clue only" }, "imprint": "ACL / 032", "scoreStatus": "scored_status_not_a_split_instruction", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_0b9f506f7316675b", "label": "DailyMed（NLM）：ATACAND 坎地沙坦酯当前美国品牌标签（SPL v5；2025-07 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=94a59260-d2b6-464a-b5b9-bbc599e57e10", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-atacand-candesartan-cilexetil-32mg-90-tablet-bottle-ndc-6255964390", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国品牌标签（SPL v5；2025-07 修订）", "en": "Current U.S. DailyMed brand label (SPL v5; revised Jul 2025)" }, "dosageForm": { "zh": "ATACAND 坎地沙坦酯普通口服片", "en": "ATACAND candesartan cilexetil immediate-release oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 62559-643-90 / NDA 020838 Product 004", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片坎地沙坦酯 32 mg；90 片瓶装；FDA RS", "en": "32 mg candesartan cilexetil per tablet; 90-tablet bottle; FDA RS" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "坎地沙坦酯", "en": "candesartan cilexetil" }, "value": 32, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、分片许可或与另一种 ARB 的换算值", "en": "labelled amount per tablet; not an individual tablet count, splitting permission or conversion to another ARB" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 90, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-02", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "current_regulatory_listing_not_live_stock", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 90, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "粉红色", "en": "pink" }, "shape": { "zh": "圆形、双凸、有刻痕，约 10 mm；刻痕只作身份核对", "en": "round, biconvex and scored, approximately 10 mm; the score is an identity clue only" }, "imprint": "ACL / 032", "scoreStatus": "scored_status_not_a_split_instruction", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_0b9f506f7316675b", "label": "DailyMed（NLM）：ATACAND 坎地沙坦酯当前美国品牌标签（SPL v5；2025-07 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=94a59260-d2b6-464a-b5b9-bbc599e57e10", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-atacand-candesartan-cilexetil-4mg-30-tablet-bottle-ndc-6255964030", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=Label-4mg.jpg&setid=94a59260-d2b6-464a-b5b9-bbc599e57e10", "alt": "ATACAND 坎地沙坦酯 4 mg、NDC 62559-640-30、30 片瓶装的美国 DailyMed 官方标签面板", "archiveMarket": "美国", "labelVersion": "DailyMed SPL v5；2025-07 修订", "presentation": "ATACAND 每片坎地沙坦酯 4 mg，白色至类白色圆形有刻痕片，NDC 62559-640-30，30 片瓶装。", "notice": "此图只对应美国 4 mg、NDC 62559-640-30、30 片瓶装；不代表 8/16/32 mg、ATACAND HCT／PLUS、加拿大或其他市场包装、实时库存或个人片数，也不用于鉴定真伪。", "source": { "id": "src_0b9f506f7316675b", "label": "DailyMed（NLM）：ATACAND 坎地沙坦酯当前美国品牌标签（SPL v5；2025-07 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=94a59260-d2b6-464a-b5b9-bbc599e57e10", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "ATACAND 说明书放大阅读：先分清单方、复方、每片 mg 与完整药单", "en": "ATACAND label reading: separate single ingredient, combinations, mg per tablet and the complete medicine list" }, "summary": { "zh": "4、8、16、32 mg 是每片坎地沙坦酯标示量，30/90 Tablets 是瓶内片数；它们不是个人每次片数。ATACAND HCT／PLUS 另含氢氯噻嗪，必须作为不同产品核对。", "en": "The 4, 8, 16 and 32 mg figures are labelled candesartan cilexetil amounts per tablet, while 30/90 Tablets are bottle counts; neither is an individual dose. ATACAND HCT/PLUS additionally contains hydrochlorothiazide and must be checked as a different product." }, "checks": [ { "zh": "四种片剂都有刻痕，但刻痕是官方外观身份线索，不是网页允许所有人掰片、拼规格或把两片换成另一强度的许可。", "en": "All four tablets are scored, but a score is an official appearance clue—not web permission for everyone to split, assemble strengths or replace one strength with two tablets." }, { "zh": "标签有胎儿毒性黑框警告。已经怀孕、可能怀孕或计划怀孕时，应尽快联系负责治疗的专业人员核对，不要仅凭网页继续、停用或自行换药。", "en": "The label has a boxed warning for fetal toxicity. If pregnant, possibly pregnant or planning pregnancy, promptly contact the responsible clinician; do not continue, stop or self-switch from a webpage alone." }, { "zh": "糖尿病患者与阿利吉仑同用属于标签禁忌；补钾剂、含钾代盐、保钾利尿药、锂、NSAID 止痛药及另一种影响肾素-血管紧张素系统的药物都应按完整药单、肾功能和血钾核对。网页不自动判断能否同服或如何错开。", "en": "Co-use with aliskiren is contraindicated in patients with diabetes. Potassium supplements or salt substitutes, potassium-sparing diuretics, lithium, NSAID pain medicines and another renin-angiotensin-system medicine require review of the complete list, kidney function and potassium. The site does not decide co-use or invent a separation interval." }, { "zh": "面、唇、舌或喉部突然肿胀，呼吸或吞咽困难，晕厥或其他严重急性表现可能是急症，应立即使用当地急救服务并带上全部药盒。", "en": "Sudden swelling of the face, lips, tongue or throat, trouble breathing or swallowing, fainting or another severe acute feature may be an emergency. Use local emergency services immediately and take every medicine pack." } ], "source": { "id": "src_0b9f506f7316675b", "label": "DailyMed（NLM）：ATACAND 坎地沙坦酯当前美国品牌标签（SPL v5；2025-07 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=94a59260-d2b6-464a-b5b9-bbc599e57e10", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "坎地沙坦酯怎样起作用：前药转化后阻断血管紧张素 II 的 AT1 受体", "en": "How candesartan cilexetil works: a prodrug converted to an angiotensin-II AT1-receptor blocker" }, "summary": { "zh": "坎地沙坦酯在胃肠道吸收过程中转化为坎地沙坦，选择性阻断血管紧张素 II 的 AT1 受体作用。这个机制解释为何血压、肾功能、血钾和完整药单重要，但不能从机制或一次血压读数推导个人片数、加量、停药或换药。", "en": "Candesartan cilexetil is converted to candesartan during gastrointestinal absorption and selectively blocks angiotensin-II activity at the AT1 receptor. This explains why blood pressure, kidney function, potassium and the full medicine list matter, but neither the mechanism nor one reading determines an individual's tablets, increase, stop or switch." }, "checks": [ { "zh": "同为 ARB 不表示 ATACAND、COZAAR、DIOVAN、BENICAR、AVAPRO 或 MICARDIS 可以按 mg 一对一换算、轮换或叠加。", "en": "Sharing the ARB class does not make ATACAND, COZAAR, DIOVAN, BENICAR, AVAPRO or MICARDIS one-to-one milligram conversions or medicines to alternate or combine." }, { "zh": "头晕或血压读数变化不能单独证明过量、漏服或需要补服。严重胸痛、呼吸困难、晕厥或神经系统急症表现应立即使用当地急救；其他新症状及时联系负责团队。", "en": "Dizziness or a blood-pressure change alone does not prove overdose, a missed dose or a need to make up use. Severe chest pain, breathing difficulty, fainting or neurologic emergency features require immediate local emergency care; contact the responsible team promptly for other new symptoms." }, { "zh": "ATACAND HCT／PLUS 把坎地沙坦酯与氢氯噻嗪放在同一片中；共同品牌词根不表示能用两盒单方自行拼成复方或拆分复方方案。", "en": "ATACAND HCT/PLUS combines candesartan cilexetil and hydrochlorothiazide in one tablet. A shared brand stem does not permit self-assembling the combination from two packs or dismantling a combination regimen." } ], "source": { "id": "src_0b9f506f7316675b", "label": "DailyMed（NLM）：ATACAND 坎地沙坦酯当前美国品牌标签（SPL v5；2025-07 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=94a59260-d2b6-464a-b5b9-bbc599e57e10", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "ATACAND", "generic": "坎地沙坦酯", "dosageFormClass": "坎地沙坦酯普通口服片：4 mg、8 mg、16 mg、32 mg；本页不并入 ATACAND HCT／PLUS 复方，也不把有刻痕解释为自行分片许可" }, "labelSource": { "id": "src_0b9f506f7316675b", "label": "DailyMed（NLM）：ATACAND 坎地沙坦酯当前美国品牌标签（SPL v5；2025-07 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=94a59260-d2b6-464a-b5b9-bbc599e57e10", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, "productRoutes": [ { "source": { "id": "src_0b9f506f7316675b", "label": "DailyMed（NLM）：ATACAND 坎地沙坦酯当前美国品牌标签（SPL v5；2025-07 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=94a59260-d2b6-464a-b5b9-bbc599e57e10", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-09-02", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_10e511bf83430e3b", "label": "FDA Orange Book：ATACAND NDA 020838 四个口服片规格均为 RLD，32 mg 同时为 RS（数据 2026-08-26 获取）", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-08-29", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_767379654dd27819", "label": "FDA Drugs@FDA：ATACAND NDA 020838 申请档案", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=020838", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-09-02", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-09-02", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "ATACAND 是坎地沙坦酯单方口服片，属于 ARB。它不等于 ATACAND HCT／PLUS 复方，也不能与 COZAAR、DIOVAN、BENICAR、AVAPRO、MICARDIS 或其他降压药按 mg 自行换算、轮换或叠加。老人和多药使用者应优先核对完整药单、血压相关症状、肾功能和血钾；网页不生成个人片数、频次、补服、停药或换药方案。", "history": "FDA Orange Book 当前数据记录 ATACAND NDA 020838 的四个普通口服片产品于 1998-06-04 获批。当前美国标签由 ANI Pharmaceuticals 发布，写明 ATACAND 商标属于 AstraZeneca 集团并许可给 ANI，产品在 Takeda Pharmaceutical Company, Ltd. 许可下生产。加拿大当前 Marketed 数据列出四个由 CHEPLAPHARM Arzneimittel GmbH 持有的 ATACAND DIN。", "sourceDocuments": [ { "id": "src_0b9f506f7316675b", "label": "DailyMed（NLM）：ATACAND 坎地沙坦酯当前美国品牌标签（SPL v5；2025-07 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=94a59260-d2b6-464a-b5b9-bbc599e57e10", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, { "id": "src_10e511bf83430e3b", "label": "FDA Orange Book：ATACAND NDA 020838 四个口服片规格均为 RLD，32 mg 同时为 RS（数据 2026-08-26 获取）", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, { "id": "src_767379654dd27819", "label": "FDA Drugs@FDA：ATACAND NDA 020838 申请档案", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=020838", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, { "id": "src_f569b57eee87a182", "label": "Health Canada：药品产品数据库（DPD）当前访问页；在库内核对 ATACAND 与四个 DIN", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_lookup_entry", "documentKind": "regulatory_lookup", "market": "CA", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-09-13", "reviewedAt": "2026-09-13" } ], "applicationNumber": "FDA NDA 020838（ATACAND／candesartan cilexetil；四规格 RLD；32 mg 为 RS）", "approvalTimeline": [ { "date": "1998-06-04", "title": { "zh": "FDA 批准 ATACAND 四种口服片", "en": "FDA approved four ATACAND oral-tablet strengths" }, "detail": { "zh": "Orange Book 当前数据把 4/8/16/32 mg 与 NDA 020838、处方 RLD 和该批准日期相连；32 mg 同时为 RS。", "en": "Current Orange Book data connect 4/8/16/32 mg with NDA 020838, prescription RLD status and this approval date; 32 mg is also the RS." }, "source": { "id": "src_10e511bf83430e3b", "label": "FDA Orange Book：ATACAND NDA 020838 四个口服片规格均为 RLD，32 mg 同时为 RS（数据 2026-08-26 获取）", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } }, { "date": "2025-07", "title": { "zh": "当前美国处方信息修订", "en": "Current U.S. prescribing information revised" }, "detail": { "zh": "DailyMed SPL v5 保留四种规格、准确包装、黑框警告、相互作用与患者信息。", "en": "DailyMed SPL v5 retains four strengths, exact packs, boxed warning, interactions and patient information." }, "source": { "id": "src_0b9f506f7316675b", "label": "DailyMed（NLM）：ATACAND 坎地沙坦酯当前美国品牌标签（SPL v5；2025-07 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=94a59260-d2b6-464a-b5b9-bbc599e57e10", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "四个处方 RLD 规格当前在册；32 mg 为 RS", "en": "Four prescription RLD strengths currently listed; 32 mg is the RS" }, "detail": { "zh": "官方包装图与监管在册不等于具体药房实时库存、购买资格或个人适用性。", "en": "Official pack images and regulatory listing do not establish live pharmacy stock, purchasing eligibility or individual suitability." } }, { "market": { "zh": "加拿大", "en": "Canada" }, "status": { "zh": "四个 ATACAND 坎地沙坦酯 DIN 当前列为 Marketed", "en": "Four ATACAND candesartan cilexetil DINs currently listed as Marketed" }, "detail": { "zh": "加拿大状态不外推美国、中国大陆或其他市场。", "en": "Canadian status is not projected onto the United States, Mainland China or another market." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "ATACAND 和 ATACAND HCT／PLUS 是同一种药吗？", "en": "Are ATACAND and ATACAND HCT/PLUS the same medicine?" }, "answer": { "zh": "不是同一产品。ATACAND 是坎地沙坦酯单方；HCT／PLUS 还含氢氯噻嗪。不要按商品名或毫克数自行叠加、替代或拆分。", "en": "They are not the same product. ATACAND is single-ingredient candesartan cilexetil; HCT/PLUS also contains hydrochlorothiazide. Do not self-combine, substitute or dismantle them from names or milligram figures." } }, { "question": { "zh": "ATACAND 有刻痕，可以自己掰半吗？", "en": "ATACAND is scored; can I halve it myself?" }, "answer": { "zh": "刻痕只作为准确产品外观线索。能否分割必须核对手中市场、强度、现行说明书、处方和专业指示；网页不提供通用分片许可。", "en": "The score is an exact-product appearance clue. Splitting requires the market, strength, current label, prescription and professional instruction for the product in hand; the site gives no universal permission." } }, { "question": { "zh": "可以把 ATACAND 和另一种沙坦类药轮换着吃吗？", "en": "Can ATACAND be alternated with another sartan?" }, "answer": { "zh": "不要这样做。不同 ARB 不是按 mg 自动等量的同一种药，同时出现也可能是重复或专业人员有意安排；请让开方团队或药师核对准确药盒与完整药单。", "en": "Do not do this. Different ARBs are not automatically equivalent by milligrams, and co-listing may be duplication or an intentional professional plan. Have the prescriber or pharmacist review the exact packs and complete list." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "same-class-is-not-same-medicine", "dose-unit-literacy" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/atacand/", "en": "https://origindrug.com/en/drugs/atacand/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "naprosyn", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-09-04", "status": "published_traceable_archive" }, "names": { "brand": "NAPROSYN", "generic": "萘普生／萘普生钠", "aliases": [ "Naprosyn", "EC-NAPROSYN", "ANAPROX DS", "naproxen", "naproxen sodium", "萘普生", "萘普生钠", "naproxen tablets", "萘普生片", "NAPROSYN", "NDA 017581", "NDA 018164", "NDA 020067", "69437-316-01", "69437-415-01", "69437-416-01", "69437-203-01", "NPR LE 500", "NPR EC 375", "NPR EC 500", "NPS 550" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "疼痛与炎症", "sourceArchiveMarket": "美国 DailyMed 当前公开标签同时列出 NAPROSYN 萘普生普通片 500 mg、EC-NAPROSYN 萘普生延迟释放片 375 mg/500 mg、ANAPROX DS 萘普生钠片 550 mg。三个商品名、两种化学形式、两种释放设计和四个包装必须分开核对；公开标签与 NDC 不证明当前库存或适合个人使用。", "dosageFormClass": "口服片：NAPROSYN 500 mg 是普通萘普生片；EC-NAPROSYN 375/500 mg 是延迟释放肠溶片，必须保持包衣完整；ANAPROX DS 550 mg 是萘普生钠片，标签注明相当于萘普生 500 mg并含 50 mg 钠。它们不是按包装数字自行互换、叠加或分片的算术题。", "dosageFormClassCode": "oral_modified_release", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "1976（美国初始批准）", "archiveSponsorText": "Atnahs Pharma US Limited（标签持有人）／Canton Laboratories（美国分销标签）" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [ "NAPROSYN", "EC-NAPROSYN", "ANAPROX DS", "萘普生片", "萘普生钠片" ], "excludedProductCues": [ "ALEVE", "naproxen sodium 220 mg OTC", "NAPRELAN", "VIMOVO", "generic naproxen product", "generic naproxen sodium product" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-naprosyn-naproxen-tablet-500mg-100-bottle-ndc-69437-316-01", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（页面 2025-01-03 更新；处方信息 2024-11 修订）", "en": "Current U.S. DailyMed public label (page updated 3 Jan 2025; prescribing information revised Nov 2024)" }, "dosageForm": { "zh": "NAPROSYN 萘普生普通口服片", "en": "NAPROSYN naproxen conventional oral tablet" }, "route": { "zh": "口服（准确产品身份字段）", "en": "oral (exact-product identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 69437-316-01", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片萘普生 500 mg；100 片瓶装；不是个人片数", "en": "naproxen 500 mg per tablet; 100-tablet bottle; not an individual's tablet count" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "萘普生", "en": "naproxen" }, "value": 500, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、频率、疗程、分片或换算指令", "en": "labelled amount per tablet; not an individual's tablet count, frequency, course, splitting or conversion instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "塑料瓶", "en": "plastic bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-04", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "黄色", "en": "yellow" }, "shape": { "zh": "胶囊形、单侧刻痕；刻痕只作准确产品外观核对", "en": "capsule-shaped with a score on one side; the score is only an exact-product appearance clue" }, "imprint": "NPR / LE / 500", "scoreStatus": "scored_status_not_a_self_split_instruction", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_22def3251c8b0839", "label": "DailyMed（NLM）：NAPROSYN／EC-NAPROSYN／ANAPROX DS 当前美国公开标签、用药指南及四个准确包装面板（2025-01-03 更新；处方信息 2024-11 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=8bff5df5-d856-4237-b6a8-ae445b454844", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-ec-naprosyn-naproxen-delayed-release-tablet-375mg-100-bottle-ndc-69437-415-01", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（页面 2025-01-03 更新；处方信息 2024-11 修订）", "en": "Current U.S. DailyMed public label (page updated 3 Jan 2025; prescribing information revised Nov 2024)" }, "dosageForm": { "zh": "EC-NAPROSYN 萘普生延迟释放口服片", "en": "EC-NAPROSYN naproxen delayed-release oral tablet" }, "route": { "zh": "口服（准确产品身份字段）", "en": "oral (exact-product identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 69437-415-01", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片萘普生 375 mg；100 片瓶装；不是个人片数", "en": "naproxen 375 mg per tablet; 100-tablet bottle; not an individual's tablet count" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "萘普生", "en": "naproxen" }, "value": 375, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、频率、疗程、分片或换算指令", "en": "labelled amount per tablet; not an individual's tablet count, frequency, course, splitting or conversion instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "塑料瓶", "en": "plastic bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-04", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "白色", "en": "white" }, "shape": { "zh": "椭圆形双凸包衣片，无刻痕；不可掰开、压碎或咀嚼", "en": "oval biconvex coated tablet without a score; do not break, crush or chew" }, "imprint": "NPR / EC / 375", "scoreStatus": "unscored_delayed_release_do_not_break_crush_or_chew", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_22def3251c8b0839", "label": "DailyMed（NLM）：NAPROSYN／EC-NAPROSYN／ANAPROX DS 当前美国公开标签、用药指南及四个准确包装面板（2025-01-03 更新；处方信息 2024-11 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=8bff5df5-d856-4237-b6a8-ae445b454844", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-ec-naprosyn-naproxen-delayed-release-tablet-500mg-100-bottle-ndc-69437-416-01", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（页面 2025-01-03 更新；处方信息 2024-11 修订）", "en": "Current U.S. DailyMed public label (page updated 3 Jan 2025; prescribing information revised Nov 2024)" }, "dosageForm": { "zh": "EC-NAPROSYN 萘普生延迟释放口服片", "en": "EC-NAPROSYN naproxen delayed-release oral tablet" }, "route": { "zh": "口服（准确产品身份字段）", "en": "oral (exact-product identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 69437-416-01", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片萘普生 500 mg；100 片瓶装；不是个人片数", "en": "naproxen 500 mg per tablet; 100-tablet bottle; not an individual's tablet count" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "萘普生", "en": "naproxen" }, "value": 500, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、频率、疗程、分片或换算指令", "en": "labelled amount per tablet; not an individual's tablet count, frequency, course, splitting or conversion instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "塑料瓶", "en": "plastic bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-04", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "白色", "en": "white" }, "shape": { "zh": "长椭圆形包衣片，无刻痕；不可掰开、压碎或咀嚼", "en": "oblong coated tablet without a score; do not break, crush or chew" }, "imprint": "NPR / EC / 500", "scoreStatus": "unscored_delayed_release_do_not_break_crush_or_chew", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_22def3251c8b0839", "label": "DailyMed（NLM）：NAPROSYN／EC-NAPROSYN／ANAPROX DS 当前美国公开标签、用药指南及四个准确包装面板（2025-01-03 更新；处方信息 2024-11 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=8bff5df5-d856-4237-b6a8-ae445b454844", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-anaprox-ds-naproxen-sodium-tablet-550mg-100-bottle-ndc-69437-203-01", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（页面 2025-01-03 更新；处方信息 2024-11 修订）", "en": "Current U.S. DailyMed public label (page updated 3 Jan 2025; prescribing information revised Nov 2024)" }, "dosageForm": { "zh": "ANAPROX DS 萘普生钠普通口服片", "en": "ANAPROX DS naproxen sodium conventional oral tablet" }, "route": { "zh": "口服（准确产品身份字段）", "en": "oral (exact-product identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 69437-203-01", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片萘普生钠 550 mg，相当于萘普生 500 mg；100 片瓶装；不是个人片数", "en": "naproxen sodium 550 mg per tablet, equivalent to naproxen 500 mg; 100-tablet bottle; not an individual's tablet count" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "萘普生钠", "en": "naproxen sodium" }, "value": 550, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、频率、疗程、分片或换算指令", "en": "labelled amount per tablet; not an individual's tablet count, frequency, course, splitting or conversion instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "塑料瓶", "en": "plastic bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-04", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "深蓝色", "en": "dark blue" }, "shape": { "zh": "长椭圆形、双侧刻痕；刻痕只作准确产品外观核对", "en": "oblong with scores on both sides; the score is only an exact-product appearance clue" }, "imprint": "NPS / 550", "scoreStatus": "scored_status_not_a_self_split_instruction", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_22def3251c8b0839", "label": "DailyMed（NLM）：NAPROSYN／EC-NAPROSYN／ANAPROX DS 当前美国公开标签、用药指南及四个准确包装面板（2025-01-03 更新；处方信息 2024-11 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=8bff5df5-d856-4237-b6a8-ae445b454844", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "status": "withheld_repackaged_or_non_exact_visual", "title": { "zh": "四个包装身份有来源文字，但图片端点当前返回空响应", "en": "Four package identities have source text, but their image endpoints currently return empty responses" }, "summary": { "zh": "DailyMed 标签页列出 NAPROSYN 500 mg、EC-NAPROSYN 375/500 mg 与 ANAPROX DS 550 mg 的四个 100 片瓶装身份及对应图片文件名；2026-09-04 逐一复核时，四个图片端点均返回 200 状态但正文为 0 字节且类型为 text/html，因此网页暂不展示这些图片，也不以截图、零售图或相似药片代替。药名、剂型、强度、NDC、刻字和来源链接仍按四个产品分别保留。", "en": "The DailyMed label page lists four 100-tablet identities for NAPROSYN 500 mg, EC-NAPROSYN 375/500 mg and ANAPROX DS 550 mg with corresponding image filenames. On individual checks dated 4 Sep 2026, every image endpoint returned HTTP 200 but a zero-byte text/html body. The site therefore withholds these images and does not substitute screenshots, retail images or look-alike tablets. Brand, dosage form, strength, NDC, imprint and source link remain separated for all four products." }, "source": { "id": "src_22def3251c8b0839", "label": "DailyMed（NLM）：NAPROSYN／EC-NAPROSYN／ANAPROX DS 当前美国公开标签、用药指南及四个准确包装面板（2025-01-03 更新；处方信息 2024-11 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=8bff5df5-d856-4237-b6a8-ae445b454844", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "NAPROSYN 说明书放大阅读：先防重复 NSAID，再看胃肠道、心血管、肾脏和水肿", "en": "NAPROSYN enlarged label: prevent duplicate NSAIDs, then review gastrointestinal, cardiovascular, kidney and oedema risks" }, "summary": { "zh": "黑便、呕血、胸痛、气短、单侧无力或言语不清、脸或喉咙肿胀、明显少尿、快速水肿或起疱脱皮都不是靠网页继续试药的情形，应及时使用当地医疗支持。老人、既往溃疡或出血、肾病、心衰、脱水或多药同用者尤其需要先核对完整药单。", "en": "Black stools, vomiting blood, chest pain, shortness of breath, one-sided weakness or speech difficulty, face or throat swelling, markedly reduced urine, rapid swelling, blistering or skin erosion are not situations for continued self-trial from a webpage and require timely local medical support. Older adults and people with prior ulcer or bleeding, kidney disease, heart failure, dehydration or multiple medicines need priority full-list review." }, "checks": [ { "zh": "NAPROSYN、EC-NAPROSYN、ANAPROX DS、ALEVE 及其他萘普生产品会共享萘普生活性部分；标签明确不应同时使用。布洛芬、双氯芬酸、塞来昔布、依托考昔和止痛剂量阿司匹林等其他 NSAID 也不能只按商品名自行叠加。", "en": "NAPROSYN, EC-NAPROSYN, ANAPROX DS, ALEVE and other naproxen products share the naproxen active moiety; the label says naproxen-containing products should not be used together. Other NSAIDs such as ibuprofen, diclofenac, celecoxib, etoricoxib or analgesic-dose aspirin must not be self-combined by brand name." }, { "zh": "EC-NAPROSYN 是延迟释放肠溶片，必须保持包衣完整，不得掰开、压碎或咀嚼。NAPROSYN 与 ANAPROX DS 的刻痕是准确产品外观线索；是否分片仍属于具体处方和准确产品核对，不是网页普遍许可。", "en": "EC-NAPROSYN is a delayed-release enteric-coated tablet whose coating must remain intact; do not break, crush or chew it. Scores on NAPROSYN and ANAPROX DS identify the exact product. Any splitting still belongs to the exact prescription and product review, not general permission from this site." }, { "zh": "华法林、阿司匹林、氯吡格雷等影响止血的药，SSRI/SNRI 抗抑郁药、ACEI/ARB、利尿剂、地高辛、锂、甲氨蝶呤、环孢素及其他 NSAID 都需要结合完整药单核对；网页不自动生成错开或停药方案。", "en": "Warfarin, aspirin, clopidogrel and other medicines affecting haemostasis, SSRI/SNRI antidepressants, ACE inhibitors/ARBs, diuretics, digoxin, lithium, methotrexate, ciclosporin and other NSAIDs require review against the complete medicine list. The site does not generate a separation or stopping plan." }, { "zh": "NAPROSYN 500 mg、EC-NAPROSYN 500 mg 和 ANAPROX DS 550 mg 即使都与萘普生相关，也不是相同释放方式或相同化学形式；不同剂型和强度不能凭 mg 自行互换。", "en": "NAPROSYN 500 mg, EC-NAPROSYN 500 mg and ANAPROX DS 550 mg are all naproxen-related but do not share the same release pattern or chemical form. Different formulations and strengths are not self-interchangeable from milligram numbers." }, { "zh": "老人发生 NSAID 相关严重胃肠道、心血管和肾脏不良反应的风险更高。使用前应把处方药、非处方止痛药、感冒药、阿司匹林和保健品一并交给药师核对。", "en": "Older adults have higher risk of serious NSAID-associated gastrointestinal, cardiovascular and kidney reactions. Prescriptions, OTC pain or cold products, aspirin and supplements should be reviewed together by a pharmacist." } ], "source": { "id": "src_a0e33da540d57841", "label": "DailyMed（NLM）：NAPROSYN／EC-NAPROSYN／ANAPROX DS FDA 批准 NSAID 患者用药指南", "url": "https://dailymed.nlm.nih.gov/dailymed/medguide.cfm?setid=8bff5df5-d856-4237-b6a8-ae445b454844", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "patient_medication_guide", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "萘普生怎样起作用：抑制 COX-1/COX-2 与前列腺素合成", "en": "How naproxen works: inhibition of COX-1/COX-2 and prostaglandin synthesis" }, "summary": { "zh": "标签说明其机制尚未完全阐明，但涉及抑制环氧合酶 COX-1 和 COX-2，减少外周组织的前列腺素。前列腺素参与疼痛和炎症，也参与胃肠道、肾脏、血小板及妊娠相关生理，因此“能止痛”不能与风险阅读分开。", "en": "The label states that the mechanism is not fully understood but involves inhibition of cyclooxygenase COX-1 and COX-2 and reduced prostaglandin synthesis in peripheral tissues. Prostaglandins participate in pain and inflammation as well as gastrointestinal, kidney, platelet and pregnancy-related physiology, so analgesic action cannot be separated from risk reading." }, "checks": [ { "zh": "ANAPROX DS 的钠盐设计吸收更快，EC-NAPROSYN 的肠溶设计延迟吸收；吸收模式不同正是不能按相近 mg 自行替换的原因之一。", "en": "The sodium-salt design of ANAPROX DS is absorbed more rapidly, while the enteric design of EC-NAPROSYN delays absorption. Different absorption patterns are one reason similar milligram numbers do not permit self-substitution." }, { "zh": "COX/前列腺素机制不能用来判断某个人该选哪一种 NSAID、该吃几片或能否和阿司匹林同服。", "en": "The COX/prostaglandin mechanism cannot determine which NSAID an individual should use, a tablet count, or whether aspirin can be co-used." }, { "zh": "同属 NSAID 不代表可以轮换或叠加；共同机制反而提示需要先排查重复成分与胃肠道、心血管和肾脏风险。", "en": "Membership in the NSAID class does not permit rotation or combination. The shared mechanism instead signals the need to check duplication and gastrointestinal, cardiovascular and kidney risks first." } ], "source": { "id": "src_22def3251c8b0839", "label": "DailyMed（NLM）：NAPROSYN／EC-NAPROSYN／ANAPROX DS 当前美国公开标签、用药指南及四个准确包装面板（2025-01-03 更新；处方信息 2024-11 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=8bff5df5-d856-4237-b6a8-ae445b454844", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "NAPROSYN", "generic": "萘普生／萘普生钠", "dosageFormClass": "口服片：NAPROSYN 500 mg 是普通萘普生片；EC-NAPROSYN 375/500 mg 是延迟释放肠溶片，必须保持包衣完整；ANAPROX DS 550 mg 是萘普生钠片，标签注明相当于萘普生 500 mg并含 50 mg 钠。它们不是按包装数字自行互换、叠加或分片的算术题。" }, "labelSource": { "id": "src_22def3251c8b0839", "label": "DailyMed（NLM）：NAPROSYN／EC-NAPROSYN／ANAPROX DS 当前美国公开标签、用药指南及四个准确包装面板（2025-01-03 更新；处方信息 2024-11 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=8bff5df5-d856-4237-b6a8-ae445b454844", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" }, "productRoutes": [ { "source": { "id": "src_22def3251c8b0839", "label": "DailyMed（NLM）：NAPROSYN／EC-NAPROSYN／ANAPROX DS 当前美国公开标签、用药指南及四个准确包装面板（2025-01-03 更新；处方信息 2024-11 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=8bff5df5-d856-4237-b6a8-ae445b454844", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-09-04", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-09-04", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "NAPROSYN、EC-NAPROSYN 和 ANAPROX DS 都会在体内形成萘普生相关活性成分，但普通片、延迟释放片与钠盐产品不是可以凭 mg 自行替换的同一包装。老人先看胃肠道出血、心脑血管、肾功能、水肿与完整药单；不要与 ALEVE、布洛芬、其他 NSAID 或另一种萘普生产品自行叠加。", "history": "美国标签列示初始批准年份为 1976。2024-11，FDA 批准三个 NDA 的安全标签修订；DailyMed 当前页面于 2025-01-03 更新。当前公开标签由 Atnahs Pharma US Limited 制造委托信息及 Canton Laboratories 美国分销信息承载；这些标签实体与历史批准记录不等于任何市场的实时库存或购买资格。", "sourceDocuments": [ { "id": "src_a0e33da540d57841", "label": "DailyMed（NLM）：NAPROSYN／EC-NAPROSYN／ANAPROX DS FDA 批准 NSAID 患者用药指南", "url": "https://dailymed.nlm.nih.gov/dailymed/medguide.cfm?setid=8bff5df5-d856-4237-b6a8-ae445b454844", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "patient_medication_guide", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" }, { "id": "src_22def3251c8b0839", "label": "DailyMed（NLM）：NAPROSYN／EC-NAPROSYN／ANAPROX DS 当前美国公开标签、用药指南及四个准确包装面板（2025-01-03 更新；处方信息 2024-11 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=8bff5df5-d856-4237-b6a8-ae445b454844", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" }, { "id": "src_ea056d3880cfca1c", "label": "FDA：NAPROSYN NDA 017581、ANAPROX DS NDA 018164、EC-NAPROSYN NDA 020067 的 2024 年补充申请批准函", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/017581Orig1s117%2C018164Orig1s067%2C020067Orig1s026ltr.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "regulatory_approval_letter", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" } ], "applicationNumber": "NAPROSYN NDA 017581；ANAPROX DS NDA 018164；EC-NAPROSYN NDA 020067", "approvalTimeline": [ { "date": "1976", "title": { "zh": "美国标签所列初始批准年份", "en": "Initial U.S. approval year listed in the label" }, "detail": { "zh": "当前 DailyMed 标签列示 Initial U.S. Approval: 1976；该年份只定位美国品牌历史，不外推其他市场。", "en": "The current DailyMed label lists Initial U.S. Approval: 1976. This only locates U.S. brand history and is not extrapolated to another market." }, "source": { "id": "src_22def3251c8b0839", "label": "DailyMed（NLM）：NAPROSYN／EC-NAPROSYN／ANAPROX DS 当前美国公开标签、用药指南及四个准确包装面板（2025-01-03 更新；处方信息 2024-11 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=8bff5df5-d856-4237-b6a8-ae445b454844", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" } }, { "date": "2024-11-21", "title": { "zh": "FDA 批准三个 NDA 的安全标签补充申请", "en": "FDA approved safety-labelling supplements for three NDAs" }, "detail": { "zh": "批准函分别标识 NDA 017581/S-117、018164/S-067 与 020067/S-026，并附修订处方信息与用药指南。", "en": "The approval letter identifies NDA 017581/S-117, 018164/S-067 and 020067/S-026 and encloses revised prescribing information and Medication Guide." }, "source": { "id": "src_ea056d3880cfca1c", "label": "FDA：NAPROSYN NDA 017581、ANAPROX DS NDA 018164、EC-NAPROSYN NDA 020067 的 2024 年补充申请批准函", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/017581Orig1s117%2C018164Orig1s067%2C020067Orig1s026ltr.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "regulatory_approval_letter", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" } }, { "date": "2025-01-03", "title": { "zh": "DailyMed 当前公开标签页面更新", "en": "Current DailyMed public-label page updated" }, "detail": { "zh": "页面列出四个准确 NDC、每片标示量、外观、包装面板和 2024-11 修订标签。", "en": "The page lists four exact NDCs, labelled amounts per tablet, appearance, package panels and the Nov 2024 revised label." }, "source": { "id": "src_22def3251c8b0839", "label": "DailyMed（NLM）：NAPROSYN／EC-NAPROSYN／ANAPROX DS 当前美国公开标签、用药指南及四个准确包装面板（2025-01-03 更新；处方信息 2024-11 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=8bff5df5-d856-4237-b6a8-ae445b454844", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "当前公开标签与四个准确 NDC/包装面板已链接", "en": "Current public label and four exact NDC/package panels linked" }, "detail": { "zh": "公开监管档案不等于当前库存、购买渠道、真伪鉴定或个人适用性。", "en": "A public regulatory record does not establish current stock, purchase channel, authenticity or individual suitability." } }, { "market": { "zh": "中国大陆、欧盟、日本及其他市场", "en": "Mainland China, EU, Japan and other markets" }, "status": { "zh": "待逐项建立当地现行市场记录", "en": "Current local market record not yet established" }, "detail": { "zh": "不从美国 NDA、NDC、英文品牌或包装图推定当地批准、商品名、供应、原研/仿制关系或可替代性。", "en": "No local approval, brand, supply, originator/generic relationship or interchangeability is inferred from a U.S. NDA, NDC, English brand or package image." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "NAPROSYN 500 mg 和 ANAPROX DS 550 mg 是一回事吗？", "en": "Are NAPROSYN 500 mg and ANAPROX DS 550 mg the same product?" }, "answer": { "zh": "不是同一个准确产品。前者每片含萘普生 500 mg；后者每片含萘普生钠 550 mg，标签注明相当于萘普生 500 mg并含 50 mg 钠。共同活性部分不建立自行换算、替换、叠加或选择片数的许可。", "en": "They are not the same exact product. The first contains naproxen 500 mg per tablet; the second contains naproxen sodium 550 mg, labelled as equivalent to naproxen 500 mg and containing 50 mg sodium. A shared active moiety does not permit self-conversion, substitution, combination or tablet-count selection." } }, { "question": { "zh": "EC-NAPROSYN 可以掰开或磨碎吗？", "en": "Can EC-NAPROSYN be split or crushed?" }, "answer": { "zh": "不能。当前标签明确要求保持肠溶包衣完整，不得掰开、压碎或咀嚼。若吞咽困难，应携带准确药盒与处方联系药师或开方团队，不要自行改造剂型。", "en": "No. The current label requires the enteric coating to remain intact and says not to break, crush or chew the tablet. For swallowing difficulty, take the exact pack and prescription to a pharmacist or prescriber rather than altering the dosage form." } }, { "question": { "zh": "已经用了 ALEVE、布洛芬或阿司匹林，还能再用 NAPROSYN 吗？", "en": "Can NAPROSYN be added if ALEVE, ibuprofen or aspirin is already being used?" }, "answer": { "zh": "不要自行叠加。ALEVE 可能已经含萘普生钠；布洛芬和阿司匹林也属于需要优先核对的 NSAID/止血相关药。请把所有处方药、非处方药、感冒止痛复方和保健品交给药师按准确产品逐项检查。", "en": "Do not self-combine them. ALEVE may already contain naproxen sodium; ibuprofen and aspirin are also priority NSAID/haemostasis review medicines. Give all prescriptions, OTC products, cold/pain combinations and supplements to a pharmacist for exact-product review." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "dosage-forms-are-part-of-medicine-identity", "same-class-is-not-same-medicine", "how-to-read-a-drug-label" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/naprosyn/", "en": "https://origindrug.com/en/drugs/naprosyn/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "feldene-piroxicam", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-09-13", "status": "published_traceable_archive" }, "names": { "brand": "FELDENE", "generic": "吡罗昔康（piroxicam）口服胶囊", "aliases": [ "FELDENE", "Feldene", "piroxicam", "吡罗昔康", "吡罗昔康胶囊", "piroxicam capsules", "NDA 018147" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "疼痛与炎症", "sourceArchiveMarket": "本页建立的是美国 FELDENE NDA 018147 的有日期公开档案：FDA 2021-04 品牌处方信息列出 10 mg 和 20 mg 口服胶囊，DailyMed 公开患者用药指南于 2025-01 修订。两项来源不能证明今天的库存、购买渠道、真伪，也不能推定中国大陆、欧盟、日本或其他市场的批准、供应或可替代关系。", "dosageFormClass": "口服胶囊。FDA 有日期文件列出 10 mg 与 20 mg 两种标签强度；不同药品、不同 NSAID 或不同市场包装不能只按 mg 数自行替换、叠加或选择片数。", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "1982（FDA 2021 标签所列美国初始批准年份）", "archiveSponsorText": "Pfizer（所审阅美国品牌历史标签及患者用药指南来源）" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [ "FELDENE", "piroxicam capsules", "吡罗昔康胶囊" ], "excludedProductCues": [ "piroxicam gel", "piroxicam injection", "generic piroxicam product", "other NSAID" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "status": "withheld_repackaged_or_non_exact_visual", "title": { "zh": "无经逐项核实的准确 FELDENE 包装图，页面不以相似药盒代替", "en": "No exact FELDENE package image was individually verified; look-alike packs are not substituted" }, "summary": { "zh": "本页审阅的 FDA 品牌标签和 DailyMed 患者用药指南用于药品身份与安全阅读，不提供一张可核验为准确市场包装的公开图。因此页面保留剂型与来源文字，不展示零售图、相似胶囊或截图来暗示准确包装、供应或真伪。", "en": "The reviewed FDA brand label and DailyMed Medication Guide support identity and safety reading, not an exact publicly verifiable market-pack image. The page therefore retains dosage-form and source text and withholds retail images, look-alike capsules and screenshots that could imply an exact package, availability or authenticity." }, "source": { "id": "src_c1e4431b9d9cd597", "label": "FDA：FELDENE（吡罗昔康）10 mg／20 mg 口服胶囊美国处方信息（NDA 018147；2021-04 修订；有日期历史文件）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/018147s050lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-13", "reviewedAt": "2026-09-13" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "FELDENE 说明书放大阅读：先排除重复 NSAID，再识别出血、心血管和严重皮肤警讯", "en": "FELDENE enlarged label: first exclude duplicate NSAIDs, then recognise bleeding, cardiovascular and serious skin warnings" }, "summary": { "zh": "黑便、呕血、胸痛、气短、单侧无力或言语不清、脸或喉咙肿胀、明显少尿、快速水肿、起疱或皮肤脱落不是继续依赖网页试用的情形，应及时使用当地医疗支持。网页不提供个人剂量、频率、疗程、补服或换药方案。", "en": "Black stools, vomiting blood, chest pain, shortness of breath, one-sided weakness or speech difficulty, face or throat swelling, markedly reduced urine, rapid swelling, blistering or skin peeling are not situations for continued self-trial from a webpage and require timely local medical support. The site provides no individual dose, frequency, course, catch-up or switching plan." }, "checks": [ { "zh": "不要只按“止痛”用途把 FELDENE 与布洛芬、萘普生、双氯芬酸、塞来昔布、依托考昔或阿司匹林等 NSAID 自行叠加、轮换或换算。共同类别反而提示先核对重复成分与风险。", "en": "Do not self-combine, alternate or convert FELDENE with ibuprofen, naproxen, diclofenac, celecoxib, etoricoxib or aspirin merely because they are used for pain. The shared NSAID class instead signals a need to check duplication and risk first." }, { "zh": "既往溃疡或消化道出血、抗凝或影响止血的药、SSRI/SNRI、ACEI/ARB、利尿剂、锂、甲氨蝶呤及其他 NSAID 同在药单时，需要结合完整清单和准确产品核对；网页不生成错开或停药指令。", "en": "Prior ulcer or gastrointestinal bleeding, medicines affecting haemostasis, SSRI/SNRI medicines, ACE inhibitors/ARBs, diuretics, lithium, methotrexate and other NSAIDs on the same list require review against the complete list and exact product; the site does not generate spacing or stopping instructions." }, { "zh": "FDA 用药指南提示 NSAID 可能出现严重心血管和胃肠道不良反应。老人、心血管病、肾病、心衰、脱水或多药同用者不应把“常见止痛药”理解为可以自行加用。", "en": "The FDA Medication Guide warns that NSAIDs can cause serious cardiovascular and gastrointestinal adverse reactions. Older adults and people with cardiovascular disease, kidney disease, heart failure, dehydration or multiple medicines must not interpret a common pain medicine as permission to self-add it." }, { "zh": "药名匹配不能确认胶囊强度、具体包装、真伪或个人适用性。请同时核对实际药盒、来源日期、处方和完整药单。", "en": "A name match cannot confirm capsule strength, an exact pack, authenticity or individual suitability. Check the actual pack, source date, prescription and complete medicine list together." } ], "source": { "id": "src_701889096e111b05", "label": "DailyMed（NLM）：FELDENE（吡罗昔康）FDA 批准 NSAID 患者用药指南（Pfizer；2025-01 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/medguide.cfm?setid=dedef9e5-23de-49ff-895a-30906b5c7da3", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "patient_medication_guide", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-13", "reviewedAt": "2026-09-13" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "吡罗昔康怎样起作用：NSAID 与前列腺素路径的风险阅读", "en": "How piroxicam works: NSAID and prostaglandin-pathway risk reading" }, "summary": { "zh": "FDA 标签将吡罗昔康归为 NSAID。对普通阅读者，更重要的是共同机制不等于共同用法：前列腺素路径与疼痛、炎症以及胃肠道、肾脏、血小板和妊娠相关生理有关，不能从机制页面推出个人该吃多少或是否应替换另一种药。", "en": "The FDA label classifies piroxicam as an NSAID. For ordinary readers, the key point is that a shared mechanism does not create a shared regimen: prostaglandin pathways relate to pain and inflammation as well as gastrointestinal, kidney, platelet and pregnancy-related physiology, and a mechanism page cannot determine an individual amount or whether another medicine should be replaced." }, "checks": [ { "zh": "NSAID 这一类别不能用来推导个人的剂量、频率、疗程、补服或换药。", "en": "The NSAID class cannot determine an individual's dose, frequency, course, catch-up or switching plan." }, { "zh": "同属 NSAID 不代表可以同时服用；应先找出药单中的重复止痛、感冒和阿司匹林产品。", "en": "Being in the same NSAID class does not permit co-use; first identify duplicate pain, cold and aspirin products on the medicine list." }, { "zh": "出现警讯时，机制解释不替代当地医疗支持。", "en": "When warning signs occur, a mechanism explanation does not replace local medical support." } ], "source": { "id": "src_c1e4431b9d9cd597", "label": "FDA：FELDENE（吡罗昔康）10 mg／20 mg 口服胶囊美国处方信息（NDA 018147；2021-04 修订；有日期历史文件）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/018147s050lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-13", "reviewedAt": "2026-09-13" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "FELDENE", "generic": "吡罗昔康（piroxicam）口服胶囊", "dosageFormClass": "口服胶囊。FDA 有日期文件列出 10 mg 与 20 mg 两种标签强度；不同药品、不同 NSAID 或不同市场包装不能只按 mg 数自行替换、叠加或选择片数。" }, "labelSource": { "id": "src_c1e4431b9d9cd597", "label": "FDA：FELDENE（吡罗昔康）10 mg／20 mg 口服胶囊美国处方信息（NDA 018147；2021-04 修订；有日期历史文件）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/018147s050lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-13", "reviewedAt": "2026-09-13" }, "productRoutes": [ { "source": { "id": "src_c1e4431b9d9cd597", "label": "FDA：FELDENE（吡罗昔康）10 mg／20 mg 口服胶囊美国处方信息（NDA 018147；2021-04 修订；有日期历史文件）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/018147s050lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-13", "reviewedAt": "2026-09-13" }, "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-09-13", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-09-13", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "FELDENE 是吡罗昔康口服 NSAID 的美国品牌历史档案。它不是“与其他止痛药都能搭配”的通用选项：先核对是否已经使用布洛芬、萘普生、双氯芬酸、塞来昔布、依托考昔或阿司匹林等 NSAID；老人、既往消化道出血、心脑血管病、肾病、心衰、脱水或多药同用者更应带完整药单请药师或医生核对。", "history": "FDA 有日期处方信息列出美国初始批准年份为 1982，并显示 2021-04 修订。DailyMed 的 FDA 批准 NSAID 患者用药指南标示 Pfizer、2025-01 修订。两个文件的日期和主体分别保留，不把历史品牌标签表述为全球或任何地区的实时售卖信息。", "sourceDocuments": [ { "id": "src_c1e4431b9d9cd597", "label": "FDA：FELDENE（吡罗昔康）10 mg／20 mg 口服胶囊美国处方信息（NDA 018147；2021-04 修订；有日期历史文件）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/018147s050lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-13", "reviewedAt": "2026-09-13" }, { "id": "src_701889096e111b05", "label": "DailyMed（NLM）：FELDENE（吡罗昔康）FDA 批准 NSAID 患者用药指南（Pfizer；2025-01 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/medguide.cfm?setid=dedef9e5-23de-49ff-895a-30906b5c7da3", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "patient_medication_guide", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-13", "reviewedAt": "2026-09-13" }, { "id": "src_5ed30b676fbb9773", "label": "FDA Drugs@FDA：FELDENE／吡罗昔康 NDA 018147 官方检索入口", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_lookup_entry", "documentKind": "regulatory_lookup", "market": "US", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } ], "applicationNumber": "FELDENE NDA 018147", "approvalTimeline": [ { "date": "1982", "title": { "zh": "美国标签所列初始批准年份", "en": "Initial U.S. approval year listed in the label" }, "detail": { "zh": "FDA 有日期处方信息列示 Initial U.S. Approval: 1982；该年份只定位美国品牌历史。", "en": "The dated FDA prescribing information lists Initial U.S. Approval: 1982; this only locates U.S. brand history." }, "source": { "id": "src_c1e4431b9d9cd597", "label": "FDA：FELDENE（吡罗昔康）10 mg／20 mg 口服胶囊美国处方信息（NDA 018147；2021-04 修订；有日期历史文件）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/018147s050lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-13", "reviewedAt": "2026-09-13" } }, { "date": "2021-04", "title": { "zh": "FDA 有日期品牌处方信息修订", "en": "Dated FDA brand prescribing-information revision" }, "detail": { "zh": "所审阅 PDF 的文件名和标签正文标识 2021-04 修订。", "en": "The reviewed PDF filename and label text identify an April 2021 revision." }, "source": { "id": "src_c1e4431b9d9cd597", "label": "FDA：FELDENE（吡罗昔康）10 mg／20 mg 口服胶囊美国处方信息（NDA 018147；2021-04 修订；有日期历史文件）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/018147s050lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-13", "reviewedAt": "2026-09-13" } }, { "date": "2025-01", "title": { "zh": "DailyMed 患者用药指南修订", "en": "DailyMed Medication Guide revision" }, "detail": { "zh": "所审阅的 FDA 批准 NSAID 患者用药指南标示 Pfizer、2025-01 修订。", "en": "The reviewed FDA-approved NSAID Medication Guide identifies Pfizer and a January 2025 revision." }, "source": { "id": "src_701889096e111b05", "label": "DailyMed（NLM）：FELDENE（吡罗昔康）FDA 批准 NSAID 患者用药指南（Pfizer；2025-01 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/medguide.cfm?setid=dedef9e5-23de-49ff-895a-30906b5c7da3", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "patient_medication_guide", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-13", "reviewedAt": "2026-09-13" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "有日期品牌标签与患者用药指南已链接", "en": "Dated brand label and Medication Guide linked" }, "detail": { "zh": "文件可定位历史监管信息，不建立当前库存、购买、真伪或个人适用性结论。", "en": "The documents locate historical regulatory information and do not establish current stock, purchase, authenticity or individual suitability." } }, { "market": { "zh": "中国大陆、欧盟、日本及其他市场", "en": "Mainland China, EU, Japan and other markets" }, "status": { "zh": "待逐项建立当地现行记录", "en": "Current local record not yet established" }, "detail": { "zh": "不从美国 NDA、英文品牌或美国标签推定当地批准、商品名、供应、原研/仿制关系或可替代性。", "en": "No local approval, brand, supply, originator/generic relationship or interchangeability is inferred from a U.S. NDA, English brand or U.S. label." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "FELDENE 能和布洛芬或萘普生一起用吗？", "en": "Can FELDENE be used with ibuprofen or naproxen?" }, "answer": { "zh": "不要仅因都用于疼痛就自行叠加。它们同属 NSAID，可能增加风险；带上全部处方药、非处方药和保健品请药师或临床医生核对。", "en": "Do not self-combine them merely because all are used for pain. They are NSAIDs and may increase risk; have all prescriptions, OTC products and supplements reviewed by a pharmacist or clinician." } }, { "question": { "zh": "10 mg 和 20 mg 能按数字自行换算吗？", "en": "Can 10 mg and 20 mg be self-converted from the numbers?" }, "answer": { "zh": "不能。标签强度是准确产品身份字段，不是个人片数、频率、补服或疗程指令。", "en": "No. Label strength is an exact-product identity field, not an individual tablet count, frequency, catch-up or course instruction." } }, { "question": { "zh": "网页没有药盒图片，怎样核对？", "en": "How can I check a product when the page has no pack image?" }, "answer": { "zh": "本页不使用未经逐项核验的相似图。请用实际药盒、通用名、剂型、来源日期、处方和当地官方查询入口进行核对；对真伪或用药存疑时请联系当地正规药师或医疗团队。", "en": "This page does not use unverified look-alike images. Check the actual pack, generic name, dosage form, source date, prescription and local official lookup route; for authenticity or medicine-use concerns, contact a local licensed pharmacist or care team." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/feldene-piroxicam/", "en": "https://origindrug.com/en/drugs/feldene-piroxicam/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "voltaren-xr-diclofenac", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-09-02", "status": "published_traceable_archive" }, "names": { "brand": "VOLTAREN-XR", "generic": "双氯芬酸钠缓释片", "aliases": [ "Voltaren XR", "Voltaren", "Cataflam", "diclofenac", "diclofenac sodium", "diclofenac potassium", "双氯芬酸", "双氯芬酸钠", "双氯芬酸钾", "扶他林", "diclofenac sodium extended release", "diclofenac sodium extended-release tablets", "双氯芬酸钠缓释片", "VOLTAREN-XR", "VOLTAREN", "CATAFLAM", "NDA 020254", "ANDA 216275", "0078-0446-05", "80425-0414-01", "80425-0414-02", "80425-0414-03", "ING 278" ], "marketBrandNames": [ { "name": "VOLTAREN-XR", "market": { "zh": "美国", "en": "United States" }, "evidenceStatus": "historical_regulatory_record", "note": { "zh": "NDA 020254、100 mg 缓释片、历史 RLD，当前 DISCN；不表示当前品牌供应。", "en": "NDA 020254, 100 mg extended-release tablet, historical RLD and currently DISCN; this does not establish current brand supply." }, "source": { "id": "src_10e511bf83430e3b", "label": "FDA Orange Book：VOLTAREN、VOLTAREN-XR 与 CATAFLAM 历史 RLD 产品记录（2026-08-26 数据）", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } } ], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "疼痛与炎症", "sourceArchiveMarket": "美国 FDA Orange Book 将 VOLTAREN-XR 双氯芬酸钠 100 mg 缓释片 NDA 020254 列为历史 RLD、当前 DISCN；2021 有日期品牌标签保留一个 100 片瓶装文字身份。DailyMed 当前仿制品标签另列 ANDA 216275 的 30、60、90 片三个瓶装身份及准确面板。历史品牌标签、当前仿制品标签、官方包装图和实时库存属于不同证据层级。", "dosageFormClass": "双氯芬酸钠 100 mg 缓释口服片；VOLTAREN 双氯芬酸钠延迟释放片、CATAFLAM 双氯芬酸钾普通片、外用凝胶和滴眼液均为不同准确产品，标签明确不同口服剂型即使 mg 相同也未必生物等效", "dosageFormClassCode": "oral_modified_release", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "1996-03-08（FDA NDA 020254 批准日期）", "archiveSponsorText": "Novartis Pharmaceuticals Corporation（历史 VOLTAREN-XR NDA）；Ingenus Pharmaceuticals／Advanced Rx of Tennessee（当前仿制品比较项）" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [ "VOLTAREN-XR", "Voltaren XR", "双氯芬酸钠缓释片" ], "excludedProductCues": [ "VOLTAREN Arthritis Pain topical gel", "VOLTAREN ophthalmic solution", "diclofenac topical", "diclofenac sodium delayed-release tablets", "CATAFLAM diclofenac potassium immediate-release tablets" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-historical-voltaren-xr-diclofenac-sodium-er-100mg-100-tablet-bottle-ndc-0078044605", "marketCode": "US", "labelVersion": { "zh": "FDA 2021-04 有日期 VOLTAREN-XR 品牌标签（历史档案）", "en": "Dated Apr 2021 FDA VOLTAREN-XR brand label (historical archive)" }, "dosageForm": { "zh": "VOLTAREN-XR 双氯芬酸钠 100 mg 缓释口服片（历史品牌）", "en": "VOLTAREN-XR diclofenac sodium 100 mg extended-release oral tablet (historical brand)" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 0078-0446-05", "pouchCode": null, "applicationNumber": "NDA 020254 Product 001", "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片双氯芬酸钠 100 mg；100 片瓶装；历史 RLD、当前 DISCN", "en": "Diclofenac sodium 100 mg per tablet; 100-tablet bottle; historical RLD, currently DISCN" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "双氯芬酸钠", "en": "diclofenac sodium" }, "value": 100, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "历史品牌标签的每片标示量；不是当前供应或个人片数", "en": "per-tablet amount in the historical brand label; not current supply or an individual tablet count" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "历史 100 片瓶装", "en": "historical 100-tablet bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-02", "currentLabelDisplayed": false, "ndcDirectoryListed": false, "marketAvailability": "historical_rld_discontinued", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "浅粉红色", "en": "light pink" }, "shape": { "zh": "圆形、双凸、斜边薄膜衣片；仅作 2021 历史标签外观文字核对", "en": "round, biconvex, bevel-edged film-coated tablet; text-only appearance from the 2021 historical label" }, "imprint": "Voltaren-XR / 100", "scoreStatus": "unscored_historical_text_only", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_676dec4d45e823d1", "label": "FDA：VOLTAREN-XR 双氯芬酸钠 100 mg 缓释片有日期品牌标签（2021-04 修订；历史标签，不代表当前品牌供应）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020254s030lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-diclofenac-sodium-er-100mg-30-tablet-bottle-ndc-80425041401", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国仿制品标签（2024-07-16 发布；处方信息 2023-10 修订）", "en": "Current U.S. DailyMed generic label (published 16 Jul 2024; prescribing information revised Oct 2023)" }, "dosageForm": { "zh": "双氯芬酸钠 100 mg 缓释口服片（仿制品比较项）", "en": "diclofenac sodium 100 mg extended-release oral tablet (generic comparator)" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 80425-0414-01", "pouchCode": null, "applicationNumber": "ANDA 216275", "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片双氯芬酸钠 100 mg；30 片瓶装", "en": "Diclofenac sodium 100 mg per tablet; 30-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=Diclofenac+Sodium+ER+100mg+80425-0414-01.jpg&setid=1d4d6370-2b45-fa6d-e063-6294a90a4a67", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "双氯芬酸钠", "en": "diclofenac sodium" }, "value": 100, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数，也不是与普通片、延迟释放片或钾盐产品的换算值", "en": "labelled amount per tablet; not an individual tablet count or a conversion to immediate-release, delayed-release or potassium-salt products" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-02", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "current_regulatory_listing_not_live_stock", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 30, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "粉红色", "en": "pink" }, "shape": { "zh": "圆形、凸面、9 mm、无刻痕；无刻痕与缓释身份都不是网页提供的分片许可", "en": "round, convex, 9 mm and unscored; neither the unscored appearance nor the extended-release identity is web permission to split" }, "imprint": "ING / 278", "scoreStatus": "unscored_no_split_permission_inferred", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_f16bd19aa58808be", "label": "DailyMed（NLM）：双氯芬酸钠 100 mg 缓释片当前美国仿制品标签、用药指南及三个准确瓶装面板（2024-07-16 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=1d4d6370-2b45-fa6d-e063-6294a90a4a67", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-diclofenac-sodium-er-100mg-60-tablet-bottle-ndc-80425041402", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国仿制品标签（2024-07-16 发布；处方信息 2023-10 修订）", "en": "Current U.S. DailyMed generic label (published 16 Jul 2024; prescribing information revised Oct 2023)" }, "dosageForm": { "zh": "双氯芬酸钠 100 mg 缓释口服片（仿制品比较项）", "en": "diclofenac sodium 100 mg extended-release oral tablet (generic comparator)" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 80425-0414-02", "pouchCode": null, "applicationNumber": "ANDA 216275", "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片双氯芬酸钠 100 mg；60 片瓶装", "en": "Diclofenac sodium 100 mg per tablet; 60-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=Diclofenac+Sodium+ER+100mg+80425-0414-02.jpg&setid=1d4d6370-2b45-fa6d-e063-6294a90a4a67", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "双氯芬酸钠", "en": "diclofenac sodium" }, "value": 100, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数，也不是与普通片、延迟释放片或钾盐产品的换算值", "en": "labelled amount per tablet; not an individual tablet count or a conversion to immediate-release, delayed-release or potassium-salt products" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 60, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-02", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "current_regulatory_listing_not_live_stock", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 60, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "粉红色", "en": "pink" }, "shape": { "zh": "圆形、凸面、9 mm、无刻痕；无刻痕与缓释身份都不是网页提供的分片许可", "en": "round, convex, 9 mm and unscored; neither the unscored appearance nor the extended-release identity is web permission to split" }, "imprint": "ING / 278", "scoreStatus": "unscored_no_split_permission_inferred", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_f16bd19aa58808be", "label": "DailyMed（NLM）：双氯芬酸钠 100 mg 缓释片当前美国仿制品标签、用药指南及三个准确瓶装面板（2024-07-16 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=1d4d6370-2b45-fa6d-e063-6294a90a4a67", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-diclofenac-sodium-er-100mg-90-tablet-bottle-ndc-80425041403", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国仿制品标签（2024-07-16 发布；处方信息 2023-10 修订）", "en": "Current U.S. DailyMed generic label (published 16 Jul 2024; prescribing information revised Oct 2023)" }, "dosageForm": { "zh": "双氯芬酸钠 100 mg 缓释口服片（仿制品比较项）", "en": "diclofenac sodium 100 mg extended-release oral tablet (generic comparator)" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 80425-0414-03", "pouchCode": null, "applicationNumber": "ANDA 216275", "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片双氯芬酸钠 100 mg；90 片瓶装", "en": "Diclofenac sodium 100 mg per tablet; 90-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=Diclofenac+Sodium+ER+100mg+80425-0414-03.jpg&setid=1d4d6370-2b45-fa6d-e063-6294a90a4a67", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "双氯芬酸钠", "en": "diclofenac sodium" }, "value": 100, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数，也不是与普通片、延迟释放片或钾盐产品的换算值", "en": "labelled amount per tablet; not an individual tablet count or a conversion to immediate-release, delayed-release or potassium-salt products" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 90, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-02", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "current_regulatory_listing_not_live_stock", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 90, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "粉红色", "en": "pink" }, "shape": { "zh": "圆形、凸面、9 mm、无刻痕；无刻痕与缓释身份都不是网页提供的分片许可", "en": "round, convex, 9 mm and unscored; neither the unscored appearance nor the extended-release identity is web permission to split" }, "imprint": "ING / 278", "scoreStatus": "unscored_no_split_permission_inferred", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_f16bd19aa58808be", "label": "DailyMed（NLM）：双氯芬酸钠 100 mg 缓释片当前美国仿制品标签、用药指南及三个准确瓶装面板（2024-07-16 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=1d4d6370-2b45-fa6d-e063-6294a90a4a67", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-diclofenac-sodium-er-100mg-30-tablet-bottle-ndc-80425041401", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=Diclofenac+Sodium+ER+100mg+80425-0414-01.jpg&setid=1d4d6370-2b45-fa6d-e063-6294a90a4a67", "alt": "双氯芬酸钠缓释片 100 mg、NDC 80425-0414-01、30 片瓶装的 DailyMed 官方仿制品标签面板", "archiveMarket": "美国", "labelVersion": "DailyMed 当前仿制品标签（2024-07-16 发布）", "presentation": "仿制品比较项：每片双氯芬酸钠 100 mg，粉红色圆形无刻痕片，ING／278，NDC 80425-0414-01，30 片瓶装。", "notice": "此图是当前仿制品比较项，不是历史 VOLTAREN-XR 原品牌包装；仅对应 30 片瓶，不代表 60/90 片瓶、延迟释放片、双氯芬酸钾普通片、外用凝胶或实时库存，也不用于鉴定真伪。", "source": { "id": "src_f16bd19aa58808be", "label": "DailyMed（NLM）：双氯芬酸钠 100 mg 缓释片当前美国仿制品标签、用药指南及三个准确瓶装面板（2024-07-16 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=1d4d6370-2b45-fa6d-e063-6294a90a4a67", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "VOLTAREN-XR 说明书放大阅读：先分清盐、释放方式、每片 mg 与 NSAID 重复", "en": "VOLTAREN-XR enlarged label: separate salt, release design, mg per tablet and duplicate NSAIDs" }, "summary": { "zh": "100 mg 是每片双氯芬酸钠标示量，30/60/90/100 Tablets 是不同瓶装数量，不是个人每次片数。品牌缓释片、钠盐延迟释放片与钾盐普通片不是按相同 mg 自动等效的产品。", "en": "The 100 mg figure is labelled diclofenac sodium per tablet, while 30/60/90/100 Tablets are different bottle counts—not an individual tablet count. Brand extended-release, sodium delayed-release and potassium immediate-release tablets are not automatically equivalent at the same milligram number." }, "checks": [ { "zh": "当前仿制品为粉红色圆形无刻痕缓释片。无刻痕和缓释字样都不是网页允许切开、压碎、磨粉或用半片替代另一规格的许可；须核对手中准确产品、处方和现行说明书。", "en": "The current generic comparator is a pink, round, unscored extended-release tablet. Neither the unscored appearance nor the extended-release wording is web permission to cut, crush, powder or replace another strength with half a tablet; check the exact product, prescription and current label in hand." }, { "zh": "不要与 NAPROSYN、ALEVE、ADVIL、MOBIC、CELEBREX、ARCOXIA、阿司匹林止痛剂量或其他 NSAID 自行叠加。不同商品名可能仍属于同类风险，网页不生成错开时间或替换方案。", "en": "Do not self-combine it with NAPROSYN, ALEVE, ADVIL, MOBIC, CELEBREX, ARCOXIA, analgesic-dose aspirin or another NSAID. Different brand names may still share class risks; the site does not generate separation or substitution plans." }, { "zh": "老人、既往溃疡或出血、心血管病、心衰、水肿、肝肾功能异常者，以及同时使用抗凝/抗血小板药、激素、SSRI/SNRI、ACEI/ARB、利尿剂、锂、甲氨蝶呤或环孢素者，应优先交由药师或临床团队核对。", "en": "Older adults; people with prior ulcer or bleeding, cardiovascular disease, heart failure, oedema, hepatic or renal impairment; and those co-using anticoagulant/antiplatelet medicines, corticosteroids, an SSRI/SNRI, ACE inhibitor/ARB, diuretic, lithium, methotrexate or ciclosporin require priority pharmacist or clinical review." }, { "zh": "胸痛、单侧无力或言语含糊、呼吸困难、面喉肿胀、呕血、黑便、严重皮疹伴发热或其他严重急性表现，应立即使用当地急救服务并带上全部药盒。", "en": "Chest pain, one-sided weakness or slurred speech, breathing difficulty, face/throat swelling, vomiting blood, black stool, severe rash with fever or another severe acute feature requires immediate local emergency care; take every medicine pack." } ], "source": { "id": "src_f16bd19aa58808be", "label": "DailyMed（NLM）：双氯芬酸钠 100 mg 缓释片当前美国仿制品标签、用药指南及三个准确瓶装面板（2024-07-16 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=1d4d6370-2b45-fa6d-e063-6294a90a4a67", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "双氯芬酸怎样起作用：抑制 COX-1／COX-2，减少前列腺素形成", "en": "How diclofenac works: COX-1/COX-2 inhibition reduces prostaglandin formation" }, "summary": { "zh": "标签说明双氯芬酸通过抑制 COX-1 和 COX-2，减少前列腺素合成，从而产生镇痛、抗炎和解热作用。这个共同机制也解释了为什么胃肠道、心血管、肾脏、出血、水肿和 NSAID 重复需要一起核对，但不能从机制推导个人剂量或换药。", "en": "The label explains that diclofenac inhibits COX-1 and COX-2 and reduces prostaglandin synthesis, producing analgesic, anti-inflammatory and antipyretic effects. The shared mechanism also explains why gastrointestinal, cardiovascular, renal, bleeding, oedema and duplicate-NSAID risks require review, but it cannot determine an individual dose or switch." }, "checks": [ { "zh": "VOLTAREN-XR、VOLTAREN 延迟释放片和 CATAFLAM 双氯芬酸钾普通片共享双氯芬酸相关成分，却具有不同盐型或释放设计；标签明确即使 mg 相同也未必生物等效。", "en": "VOLTAREN-XR, VOLTAREN delayed-release tablets and CATAFLAM immediate-release diclofenac potassium share diclofenac-related ingredients but differ in salt or release design; the label says they are not necessarily bioequivalent even at the same milligram strength." }, { "zh": "外用 VOLTAREN Arthritis Pain 凝胶和滴眼用 VOLTAREN 也是不同途径产品，不能把外用百分比、口服 mg 或滴眼浓度放在同一换算表。", "en": "Topical VOLTAREN Arthritis Pain gel and ophthalmic VOLTAREN are different-route products; topical percentage, oral milligrams and ophthalmic concentration do not belong in one conversion table." }, { "zh": "药效机制不能回答个人‘应该吃几片’。若药盒、处方或药单同时出现多个止痛抗炎产品，应先暂停自行加药并让药师按准确成分、剂型和商品逐项核对。", "en": "Mechanism cannot answer how many tablets an individual should take. If several pain or anti-inflammatory products appear across packs, prescriptions or the medicine list, do not self-add another product; have a pharmacist review exact ingredients, dosage forms and brands." } ], "source": { "id": "src_676dec4d45e823d1", "label": "FDA：VOLTAREN-XR 双氯芬酸钠 100 mg 缓释片有日期品牌标签（2021-04 修订；历史标签，不代表当前品牌供应）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020254s030lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "VOLTAREN-XR", "generic": "双氯芬酸钠缓释片", "dosageFormClass": "双氯芬酸钠 100 mg 缓释口服片；VOLTAREN 双氯芬酸钠延迟释放片、CATAFLAM 双氯芬酸钾普通片、外用凝胶和滴眼液均为不同准确产品，标签明确不同口服剂型即使 mg 相同也未必生物等效" }, "labelSource": { "id": "src_f16bd19aa58808be", "label": "DailyMed（NLM）：双氯芬酸钠 100 mg 缓释片当前美国仿制品标签、用药指南及三个准确瓶装面板（2024-07-16 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=1d4d6370-2b45-fa6d-e063-6294a90a4a67", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, "productRoutes": [ { "source": { "id": "src_f16bd19aa58808be", "label": "DailyMed（NLM）：双氯芬酸钠 100 mg 缓释片当前美国仿制品标签、用药指南及三个准确瓶装面板（2024-07-16 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=1d4d6370-2b45-fa6d-e063-6294a90a4a67", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-09-02", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_676dec4d45e823d1", "label": "FDA：VOLTAREN-XR 双氯芬酸钠 100 mg 缓释片有日期品牌标签（2021-04 修订；历史标签，不代表当前品牌供应）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020254s030lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-09-02", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_10e511bf83430e3b", "label": "FDA Orange Book：VOLTAREN、VOLTAREN-XR 与 CATAFLAM 历史 RLD 产品记录（2026-08-26 数据）", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-08-29", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-09-02", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "VOLTAREN-XR 是双氯芬酸钠 100 mg 缓释片的美国历史品牌档案，目前 FDA 条目为 DISCN；页面同时展示当前仿制品三个准确瓶装面板。双氯芬酸钠延迟释放片、缓释片和双氯芬酸钾普通片即使数字相近，也不是可以按 mg 自行互换的同一产品。老人、多药使用者及同时使用阿司匹林、抗凝/抗血小板药、SSRI/SNRI、ACEI/ARB、利尿剂、锂、甲氨蝶呤或另一种 NSAID 者应优先核对完整药单。", "history": "FDA Orange Book 记录 VOLTAREN-XR NDA 020254 于 1996-03-08 获批；其 2021-04 标签修订加入心血管、胃肠道、胎儿肾功能、DRESS 等安全信息，FDA 同年批准 S-030。当前 Orange Book 将该品牌 RLD 列为 DISCN。DailyMed 2024-07 发布的 ANDA 216275 仿制品标签用于提供当前 100 mg 缓释剂型、三个瓶装身份及用药指南的比较阅读。", "sourceDocuments": [ { "id": "src_676dec4d45e823d1", "label": "FDA：VOLTAREN-XR 双氯芬酸钠 100 mg 缓释片有日期品牌标签（2021-04 修订；历史标签，不代表当前品牌供应）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020254s030lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, { "id": "src_3666eabe612074da", "label": "FDA：VOLTAREN-XR NDA 020254／S-030 安全标签补充批准函（2021）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/020254Orig1s030ltr.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "regulatory_approval_letter", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, { "id": "src_10e511bf83430e3b", "label": "FDA Orange Book：VOLTAREN、VOLTAREN-XR 与 CATAFLAM 历史 RLD 产品记录（2026-08-26 数据）", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, { "id": "src_f16bd19aa58808be", "label": "DailyMed（NLM）：双氯芬酸钠 100 mg 缓释片当前美国仿制品标签、用药指南及三个准确瓶装面板（2024-07-16 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=1d4d6370-2b45-fa6d-e063-6294a90a4a67", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" } ], "applicationNumber": "VOLTAREN-XR NDA 020254（历史 RLD；当前 DISCN）；当前仿制品比较项 ANDA 216275", "approvalTimeline": [ { "date": "1996-03-08", "title": { "zh": "FDA 批准 VOLTAREN-XR 100 mg 缓释片", "en": "FDA approved VOLTAREN-XR 100 mg extended-release tablets" }, "detail": { "zh": "Orange Book 当前数据把 NDA 020254、100 mg、历史 RLD 和该日期相连；当前产品状态为 DISCN。", "en": "Current Orange Book data connect NDA 020254, 100 mg, historical RLD status and this date; the current product status is DISCN." }, "source": { "id": "src_10e511bf83430e3b", "label": "FDA Orange Book：VOLTAREN、VOLTAREN-XR 与 CATAFLAM 历史 RLD 产品记录（2026-08-26 数据）", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } }, { "date": "2021-04", "title": { "zh": "FDA 批准安全标签补充修订", "en": "FDA approved a supplemental safety-labelling revision" }, "detail": { "zh": "修订涉及胎儿肾功能、羊水过少、新生儿肾损害和 DRESS 等 NSAID 安全信息。", "en": "The revision addressed NSAID safety information including fetal renal dysfunction, oligohydramnios, neonatal renal impairment and DRESS." }, "source": { "id": "src_3666eabe612074da", "label": "FDA：VOLTAREN-XR NDA 020254／S-030 安全标签补充批准函（2021）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/020254Orig1s030ltr.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "regulatory_approval_letter", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" } }, { "date": "2024-07-16", "title": { "zh": "当前仿制品 DailyMed 标签发布", "en": "Current generic DailyMed label published" }, "detail": { "zh": "标签列出 100 mg 缓释片、ING／278 外观及 30/60/90 片三个准确瓶装面板。", "en": "The label lists 100 mg extended-release tablets, the ING/278 appearance and exact 30/60/90-tablet bottle panels." }, "source": { "id": "src_f16bd19aa58808be", "label": "DailyMed（NLM）：双氯芬酸钠 100 mg 缓释片当前美国仿制品标签、用药指南及三个准确瓶装面板（2024-07-16 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=1d4d6370-2b45-fa6d-e063-6294a90a4a67", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "VOLTAREN-XR 历史 RLD 当前 DISCN；当前仿制品标签另列", "en": "Historical VOLTAREN-XR RLD currently DISCN; current generic label listed separately" }, "detail": { "zh": "历史品牌记录、当前仿制品在册和实际药房库存是不同证据层级。", "en": "Historical brand record, current generic listing and live pharmacy stock are separate evidence layers." } }, { "market": { "zh": "美国以外市场", "en": "Markets outside the United States" }, "status": { "zh": "本档案未确认当地批准、商品名、剂型、包装或供应", "en": "Local approval, brand, dosage form, package and supply are not established by this dossier" }, "detail": { "zh": "其他国家或地区须从当地药监机构与现行说明书逐项核对；美国历史品牌与当前美国仿制品资料不能外推为全球状态。", "en": "Check the local regulator and current local label market by market. Historical U.S. brand and current U.S. generic evidence must not be projected as worldwide status." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "VOLTAREN-XR 100 mg 和双氯芬酸钠延迟释放片 100 mg 一样吗？", "en": "Are VOLTAREN-XR 100 mg and 100 mg diclofenac sodium delayed-release tablets the same?" }, "answer": { "zh": "不能这样判断。缓释片、延迟释放片和普通片的释放设计不同，标签明确不同双氯芬酸口服剂型即使 mg 相同也未必生物等效；不要自行换算、拼片或替换。", "en": "No such conclusion follows. Extended-release, delayed-release and immediate-release tablets have different release designs, and the label states that different oral diclofenac formulations are not necessarily bioequivalent even at the same milligram strength. Do not self-convert, assemble tablets or substitute." } }, { "question": { "zh": "网页上的粉红色 ING／278 是原研 VOLTAREN-XR 吗？", "en": "Is the pink ING/278 tablet on this page originator VOLTAREN-XR?" }, "answer": { "zh": "不是。该图来自当前 ANDA 216275 仿制品标签；历史 VOLTAREN-XR 仅保留 FDA 标签文字身份，网页没有借用仿制品图片冒充原品牌。", "en": "No. The image comes from the current ANDA 216275 generic label. Historical VOLTAREN-XR retains only the FDA label's text identity; the site does not reuse a generic image as the originator brand." } }, { "question": { "zh": "已经用了布洛芬、萘普生、塞来昔布或阿司匹林，还能加双氯芬酸吗？", "en": "Can diclofenac be added if ibuprofen, naproxen, celecoxib or aspirin is already being used?" }, "answer": { "zh": "不要自行叠加。这些药可能共享 NSAID、出血、胃肠道、心血管或肾脏风险；请把所有处方药、OTC 止痛药、感冒复方和保健品交给药师按准确产品核对。", "en": "Do not self-combine them. These medicines may share NSAID, bleeding, gastrointestinal, cardiovascular or renal risks. Give all prescriptions, OTC pain medicines, cold combinations and supplements to a pharmacist for exact-product review." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "dosage-forms-are-part-of-medicine-identity", "same-class-is-not-same-medicine" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/voltaren-xr-diclofenac/", "en": "https://origindrug.com/en/drugs/voltaren-xr-diclofenac/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "propecia-finasteride", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-09-02", "status": "published_traceable_archive" }, "names": { "brand": "PROPECIA", "generic": "非那雄胺 1 mg 片", "aliases": [ "Propecia", "finasteride", "finasteride 1 mg", "非那雄胺", "非那雄胺片", "保法止", "finasteride tablets", "非那雄胺 1 mg", "PROPECIA", "NDA 020788", "78206-152-01", "stylized P", "PROPECIA 1 mg" ], "marketBrandNames": [ { "name": "PROPECIA", "market": { "zh": "美国", "en": "United States" }, "evidenceStatus": "current_regulatory_record", "note": { "zh": "NDA 020788、1 mg 口服片，当前处方 RLD／RS；实际供应仍须在当地核对。", "en": "NDA 020788, 1 mg oral tablet, currently prescription RLD/RS; actual supply still requires local checking." }, "source": { "id": "src_10e511bf83430e3b", "label": "FDA Orange Book：PROPECIA／finasteride 1 mg、NDA 020788、RLD／RS 当前处方产品记录（2026-08-26 数据）", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } } ], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "泌尿健康", "sourceArchiveMarket": "美国 FDA Orange Book 当前把 PROPECIA 非那雄胺 1 mg 片、NDA 020788 Product 001 列为处方 RLD 与 RS；DailyMed 公开标签列出 NDC 78206-152-01 的 30 片瓶装。监管在册、准确包装、实际库存、购买资格和个人适用性属于不同证据层级。", "dosageFormClass": "非那雄胺 1 mg 薄膜衣口服片。PROSCAR 是非那雄胺 5 mg 的另一品牌与另一准确产品身份；同一成分不等于可按 5:1 自行切片、拼片、轮换或替换。", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "1997-12-19（FDA NDA 020788 批准日期）", "archiveSponsorText": "Organon LLC（美国 NDA 当前申请持有人）" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [ "PROPECIA", "Propecia finasteride 1 mg", "保法止", "非那雄胺 1 mg 片" ], "excludedProductCues": [ "PROSCAR", "finasteride 5 mg", "非那雄胺 5 mg", "dutasteride", "AVODART" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-propecia-finasteride-tablet-1mg-30-bottle-ndc-78206-152-01", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开品牌标签（处方信息 2022-08 修订；患者信息 2023-11 修订）", "en": "Current U.S. DailyMed brand label (prescribing information revised Aug 2022; patient information revised Nov 2023)" }, "dosageForm": { "zh": "PROPECIA 非那雄胺 1 mg 薄膜衣口服片", "en": "PROPECIA finasteride 1 mg film-coated oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 78206-152-01", "pouchCode": null, "applicationNumber": "NDA 020788 Product 001", "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片非那雄胺 1 mg；30 片瓶装", "en": "Finasteride 1 mg per tablet; 30-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=propecia-03.jpg&setid=6f904709-65aa-44ce-b144-b4c8a0416e36&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "非那雄胺", "en": "finasteride" }, "value": 1, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数，也不是把 PROSCAR 5 mg 切分后的网页换算值", "en": "labelled amount per tablet; not an individual's tablet count or a web conversion made by dividing PROSCAR 5 mg" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-02", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "current_regulatory_listing_not_live_stock", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 30, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "棕褐色", "en": "tan" }, "shape": { "zh": "八边形、凸面、薄膜衣片，约 7 mm", "en": "octagonal, convex, film-coated tablet, approximately 7 mm" }, "imprint": "stylized P / PROPECIA", "scoreStatus": "unscored_no_split_permission_inferred", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_ef03160108bf8acd", "label": "DailyMed（NLM）：PROPECIA 非那雄胺 1 mg 美国公开品牌标签、患者信息及准确 30 片瓶装面板", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=6f904709-65aa-44ce-b144-b4c8a0416e36", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-propecia-finasteride-tablet-1mg-30-bottle-ndc-78206-152-01", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=propecia-03.jpg&setid=6f904709-65aa-44ce-b144-b4c8a0416e36&type=img", "alt": "PROPECIA 非那雄胺 1 mg、NDC 78206-152-01、30 片瓶装的 DailyMed 官方标签面板", "archiveMarket": "美国", "labelVersion": "DailyMed 当前美国公开品牌标签", "presentation": "每片非那雄胺 1 mg；棕褐色八边形凸面薄膜衣片，无刻痕，一面为 stylized P、一面为 PROPECIA；NDC 78206-152-01，30 片瓶装。", "notice": "此图只对应美国 NDC 78206-152-01 的 30 片瓶装，不代表其他国家包装、PROSCAR 5 mg、仿制品或实时库存，也不用于鉴定真伪。", "source": { "id": "src_ef03160108bf8acd", "label": "DailyMed（NLM）：PROPECIA 非那雄胺 1 mg 美国公开品牌标签、患者信息及准确 30 片瓶装面板", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=6f904709-65aa-44ce-b144-b4c8a0416e36", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "PROPECIA 说明书放大阅读：先分清 1 mg、30 片瓶装、PROSCAR 5 mg 与孕期接触边界", "en": "PROPECIA enlarged label: separate 1 mg, the 30-tablet bottle, PROSCAR 5 mg and pregnancy-handling boundaries" }, "summary": { "zh": "1 mg 是每片非那雄胺标示量，30 Tablets 是整瓶片数，不是个人一次片数。PROPECIA 1 mg 与 PROSCAR 5 mg 是两个准确产品身份，不能把共同成分变成自行切片或换算许可。", "en": "The 1 mg figure is labelled finasteride per tablet, while 30 Tablets is the bottle count—not an individual tablet count. PROPECIA 1 mg and PROSCAR 5 mg are separate exact product identities; a shared ingredient is not permission to split or convert them yourself." }, "checks": [ { "zh": "标签把 PROPECIA 限定在男性型脱发的男性使用场景，并明确不适用于女性。网页不根据脱发照片、年龄或症状替个人判断适用性。", "en": "The label limits PROPECIA to the male-pattern-hair-loss setting in men and states that it is not indicated for women. The site does not determine suitability from hair photographs, age or symptoms." }, { "zh": "怀孕或可能怀孕者不得接触压碎或破损的 PROPECIA 片；完整包衣片在正常拿取时可减少皮肤接触，但发现破损应避免接触并按现行说明书与医疗团队处理。", "en": "A person who is or may be pregnant must not handle crushed or broken PROPECIA tablets. The coating limits skin contact during normal handling of intact tablets, but damaged tablets require avoidance and handling according to the current label and clinical advice." }, { "zh": "非那雄胺可能影响 PSA 结果。就诊、筛查或解释 PSA 时，应主动告诉医生正在或曾经使用的准确产品、强度和时间；网页不根据一次化验值判断停药或疾病。", "en": "Finasteride may affect PSA results. Tell the clinician the exact product, strength and timing when PSA is measured or interpreted. The site does not infer interruption or disease from one test result." }, { "zh": "标签列出的不良反应与上市后报告需要结合个人情况解释；出现乳房变化、严重过敏、明显情绪变化或其他持续困扰时，应及时联系医疗团队，不要自行加量、减量或换成 5 mg 产品。", "en": "Labelled adverse reactions and postmarketing reports require individual interpretation. Breast changes, serious allergy, marked mood changes or another persistent concern needs timely clinical contact; do not self-increase, reduce or switch to a 5 mg product." } ], "source": { "id": "src_ef03160108bf8acd", "label": "DailyMed（NLM）：PROPECIA 非那雄胺 1 mg 美国公开品牌标签、患者信息及准确 30 片瓶装面板", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=6f904709-65aa-44ce-b144-b4c8a0416e36", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "非那雄胺怎样起作用：抑制 II 型 5α-还原酶，降低睾酮向 DHT 的转化", "en": "How finasteride works: type II 5α-reductase inhibition reduces conversion of testosterone to DHT" }, "summary": { "zh": "标签说明非那雄胺抑制 II 型 5α-还原酶，降低睾酮转化为二氢睾酮（DHT）。这个机制解释了它与毛囊、前列腺及妊娠接触警示的联系，但不能从机制推导个人是否需要用药、多久见效或是否可以换成 PROSCAR。", "en": "The label explains that finasteride inhibits type II 5α-reductase and reduces conversion of testosterone to dihydrotestosterone (DHT). This links the medicine to hair follicles, the prostate and pregnancy-handling warnings, but cannot determine whether an individual needs treatment, when benefit will appear or whether PROSCAR can replace it." }, "checks": [ { "zh": "PROPECIA 与 PROSCAR 共享非那雄胺成分，但强度、标签用途和准确产品身份不同；同一机制不建立 5:1 的家庭切片规则。", "en": "PROPECIA and PROSCAR share finasteride but differ in strength, labelled use and exact product identity. A shared mechanism does not create a household 5:1 tablet-splitting rule." }, { "zh": "PROPECIA 也不是度他雄胺（AVODART）。同属 5α-还原酶抑制相关药物，不代表可以按毫克数轮换、叠加或替换。", "en": "PROPECIA is not dutasteride (AVODART). A related 5α-reductase-inhibitor class does not permit milligram rotation, combination or substitution." }, { "zh": "机制和基因信息都不能单独回答个人是否适合。请结合诊断、完整药单、生育/妊娠接触情境、PSA 与既往反应，由负责团队判断。", "en": "Mechanism and genetic information alone cannot answer individual suitability. Diagnosis, the complete medicine list, reproductive/pregnancy exposure context, PSA and prior response require review by the responsible clinical team." } ], "source": { "id": "src_ef03160108bf8acd", "label": "DailyMed（NLM）：PROPECIA 非那雄胺 1 mg 美国公开品牌标签、患者信息及准确 30 片瓶装面板", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=6f904709-65aa-44ce-b144-b4c8a0416e36", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "PROPECIA", "generic": "非那雄胺 1 mg 片", "dosageFormClass": "非那雄胺 1 mg 薄膜衣口服片。PROSCAR 是非那雄胺 5 mg 的另一品牌与另一准确产品身份；同一成分不等于可按 5:1 自行切片、拼片、轮换或替换。" }, "labelSource": { "id": "src_ef03160108bf8acd", "label": "DailyMed（NLM）：PROPECIA 非那雄胺 1 mg 美国公开品牌标签、患者信息及准确 30 片瓶装面板", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=6f904709-65aa-44ce-b144-b4c8a0416e36", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, "productRoutes": [ { "source": { "id": "src_ef03160108bf8acd", "label": "DailyMed（NLM）：PROPECIA 非那雄胺 1 mg 美国公开品牌标签、患者信息及准确 30 片瓶装面板", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=6f904709-65aa-44ce-b144-b4c8a0416e36", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-09-02", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_10e511bf83430e3b", "label": "FDA Orange Book：PROPECIA／finasteride 1 mg、NDA 020788、RLD／RS 当前处方产品记录（2026-08-26 数据）", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-08-29", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-09-02", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "PROPECIA 是非那雄胺 1 mg 的美国品牌档案，用于男性型脱发的标签场景；它不是 PROSCAR 5 mg 的网页切片方案。1 mg 是每片标示量，30 Tablets 是整瓶数量。药片无刻痕，且怀孕或可能怀孕者不得接触压碎或破损的片剂；网页不会根据脱发程度、PSA、年龄或照片替个人决定是否使用。", "history": "FDA Orange Book 记录 PROPECIA NDA 020788 于 1997-12-19 获批，当前 1 mg 产品仍列为处方 RLD 与 RS。DailyMed 页面保留 2022-08 修订的处方信息、2023-11 修订的患者信息及一个准确 30 片瓶装面板。标签所写 1992 年美国初始批准指非那雄胺活性成分的初始批准历史，不等于 PROPECIA 产品在 1992 年获批。", "sourceDocuments": [ { "id": "src_ef03160108bf8acd", "label": "DailyMed（NLM）：PROPECIA 非那雄胺 1 mg 美国公开品牌标签、患者信息及准确 30 片瓶装面板", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=6f904709-65aa-44ce-b144-b4c8a0416e36", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, { "id": "src_10e511bf83430e3b", "label": "FDA Orange Book：PROPECIA／finasteride 1 mg、NDA 020788、RLD／RS 当前处方产品记录（2026-08-26 数据）", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } ], "applicationNumber": "NDA 020788 Product 001", "approvalTimeline": [ { "date": "1997-12-19", "title": { "zh": "FDA 批准 PROPECIA 1 mg 片", "en": "FDA approved PROPECIA 1 mg tablets" }, "detail": { "zh": "Orange Book 当前数据把 NDA 020788、1 mg、RLD／RS 与该批准日期相连。", "en": "Current Orange Book data connect NDA 020788, 1 mg, RLD/RS status and this approval date." }, "source": { "id": "src_10e511bf83430e3b", "label": "FDA Orange Book：PROPECIA／finasteride 1 mg、NDA 020788、RLD／RS 当前处方产品记录（2026-08-26 数据）", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } }, { "date": "2022-08", "title": { "zh": "美国处方信息修订", "en": "U.S. prescribing information revised" }, "detail": { "zh": "DailyMed 当前公开页面所列处方信息修订日期。", "en": "Revision date shown for the prescribing information on the current DailyMed public page." }, "source": { "id": "src_ef03160108bf8acd", "label": "DailyMed（NLM）：PROPECIA 非那雄胺 1 mg 美国公开品牌标签、患者信息及准确 30 片瓶装面板", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=6f904709-65aa-44ce-b144-b4c8a0416e36", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" } }, { "date": "2023-11", "title": { "zh": "美国患者信息修订", "en": "U.S. patient information revised" }, "detail": { "zh": "患者信息提供用途、接触警示、常见风险与就医沟通的通俗入口。", "en": "Patient information provides a plain-language entry to use, handling warnings, common risks and clinical communication." }, "source": { "id": "src_ef03160108bf8acd", "label": "DailyMed（NLM）：PROPECIA 非那雄胺 1 mg 美国公开品牌标签、患者信息及准确 30 片瓶装面板", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=6f904709-65aa-44ce-b144-b4c8a0416e36", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "当前处方 RLD／RS", "en": "Current prescription RLD/RS" }, "detail": { "zh": "NDA 020788 Product 001；监管在册不等于实时库存。", "en": "NDA 020788 Product 001; regulatory listing is not live stock." } }, { "market": { "zh": "美国以外市场", "en": "Markets outside the United States" }, "status": { "zh": "本档案未确认当地批准、商品名、包装或供应", "en": "Local approval, brand, pack and supply are not established by this dossier" }, "detail": { "zh": "“保法止”等名称须结合当地药监记录和手中现行说明书逐项核对。", "en": "Names such as Propecia/保法止 require market-specific checking against the local regulator and current leaflet in hand." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "PROSCAR 5 mg 能切成五份当 PROPECIA 1 mg 吗？", "en": "Can a PROSCAR 5 mg tablet be cut into five parts to make PROPECIA 1 mg?" }, "answer": { "zh": "网页不能支持这种做法。PROPECIA 1 mg 是独立处方产品，药片无刻痕；PROSCAR 5 mg 具有不同标签用途与产品身份。不要凭算术自行切片、拼片或替换，请让医生或药师按准确产品与个人情况核对。", "en": "The site cannot support that practice. PROPECIA 1 mg is a separate prescription product and its tablet is unscored; PROSCAR 5 mg has a different labelled use and product identity. Do not use arithmetic to split, assemble or substitute tablets; have a clinician or pharmacist review the exact products and personal context." } }, { "question": { "zh": "1 mg 是一次吃一颗吗？", "en": "Does 1 mg mean one tablet for me?" }, "answer": { "zh": "1 mg 只说明每片含多少非那雄胺，不是网页给出的个人片数。个人是否适合、如何使用和何时复评必须以本人处方、现行说明书和负责团队判断为准。", "en": "The 1 mg figure only states finasteride per tablet; it is not a personal tablet count from this site. Suitability, use and reassessment require the individual's prescription, current label and responsible clinical team." } }, { "question": { "zh": "看到棕褐色八边形 P／PROPECIA 就能判真伪吗？", "en": "Does a tan octagonal P/PROPECIA tablet prove authenticity?" }, "answer": { "zh": "不能。外观只能作为核对线索，还需核对市场、NDC、批号、有效期、完整包装、来源渠道和当地监管记录；网页与照片识别都不作真伪结论。", "en": "No. Appearance is only a comparison clue. Market, NDC, lot, expiry, intact packaging, supply source and local regulatory record still require checking; neither this site nor photo recognition authenticates a medicine." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "dose-unit-literacy", "same-class-is-not-same-medicine", "dosage-forms-are-part-of-medicine-identity" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/propecia-finasteride/", "en": "https://origindrug.com/en/drugs/propecia-finasteride/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "cardura-doxazosin", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-09-02", "status": "published_traceable_archive" }, "names": { "brand": "CARDURA", "generic": "多沙唑嗪普通片", "aliases": [ "Cardura", "doxazosin", "doxazosin mesylate", "多沙唑嗪", "甲磺酸多沙唑嗪", "可多华", "doxazosin tablets", "甲磺酸多沙唑嗪片", "CARDURA", "NDA 019668", "58151-074-01", "58151-075-01", "58151-076-01", "58151-077-01", "CN1 VLE", "CN2 VLE", "CN4 VLE", "CN8 VLE" ], "marketBrandNames": [ { "name": "CARDURA", "market": { "zh": "美国", "en": "United States" }, "evidenceStatus": "current_regulatory_record", "note": { "zh": "NDA 019668；当前品牌标签列 1、2、4、8 mg 普通片。监管标签不等于实时供应。", "en": "NDA 019668; the current brand label lists 1, 2, 4 and 8 mg immediate-release tablets. A regulatory label is not live supply." }, "source": { "id": "src_cf8675a49c7b1598", "label": "DailyMed（NLM）：CARDURA 多沙唑嗪当前美国品牌标签、患者信息及四个 100 片瓶装面板", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=5e1f5e49-2da1-43ab-9795-228a8bcc5a82", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" } } ], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "心血管", "sourceArchiveMarket": "美国 DailyMed 当前品牌标签列 CARDURA 1、2、4、8 mg 普通片四个 100 片瓶装，均归入 NDA 019668。网页核对的是当前标签与包装身份，不证明当地实时库存、购买资格、个人适用性或其他国家包装。", "dosageFormClass": "多沙唑嗪普通口服片。CARDURA XL 是 4 mg、8 mg 缓释片，使用不同 NDA、缓释结构、包装与说明书；即使成分和 mg 相同，也不能自行一比一替换、掰碎或拼接。", "dosageFormClassCode": "oral_modified_release", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "1990（美国初始批准年份）", "archiveSponsorText": "Viatris Specialty LLC（当前美国品牌标签分销方）" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [ "CARDURA", "Cardura doxazosin", "多沙唑嗪片", "甲磺酸多沙唑嗪片", "可多华" ], "excludedProductCues": [ "CARDURA XL", "doxazosin extended release", "多沙唑嗪缓释片", "FLOMAX", "tamsulosin", "坦索罗辛", "MINIPRESS", "prazosin", "HYTRIN", "terazosin" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-cardura-doxazosin-1mg-100-tablet-bottle-ndc-5815107401", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国品牌标签（患者信息修订 2023-10；当前 SPL 2026-07-16 发布）", "en": "Current U.S. DailyMed brand label (patient information revised Oct 2023; current SPL published 16 Jul 2026)" }, "dosageForm": { "zh": "CARDURA 多沙唑嗪普通口服片", "en": "CARDURA doxazosin immediate-release oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 58151-074-01", "pouchCode": null, "applicationNumber": "NDA 019668", "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片多沙唑嗪 1 mg；100 片瓶装", "en": "Doxazosin 1 mg per tablet; 100-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=image-04.jpg&setid=5e1f5e49-2da1-43ab-9795-228a8bcc5a82", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "多沙唑嗪（以游离碱计）", "en": "doxazosin (as free base)" }, "value": 1, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、加量步骤或与 CARDURA XL 的换算值", "en": "labelled amount per tablet; not an individual's tablet count, titration step or a conversion to CARDURA XL" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-02", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "current_regulatory_listing_not_live_stock", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "白色", "en": "white" }, "shape": { "zh": "圆形、无刻痕，约 7 mm", "en": "round and unscored, approximately 7 mm" }, "imprint": "CN1 / VLE", "scoreStatus": "unscored_no_split_permission_inferred", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_cf8675a49c7b1598", "label": "DailyMed（NLM）：CARDURA 多沙唑嗪当前美国品牌标签、患者信息及四个 100 片瓶装面板", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=5e1f5e49-2da1-43ab-9795-228a8bcc5a82", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-cardura-doxazosin-2mg-100-tablet-bottle-ndc-5815107501", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国品牌标签（患者信息修订 2023-10；当前 SPL 2026-07-16 发布）", "en": "Current U.S. DailyMed brand label (patient information revised Oct 2023; current SPL published 16 Jul 2026)" }, "dosageForm": { "zh": "CARDURA 多沙唑嗪普通口服片", "en": "CARDURA doxazosin immediate-release oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 58151-075-01", "pouchCode": null, "applicationNumber": "NDA 019668", "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片多沙唑嗪 2 mg；100 片瓶装", "en": "Doxazosin 2 mg per tablet; 100-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=image-05.jpg&setid=5e1f5e49-2da1-43ab-9795-228a8bcc5a82", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "多沙唑嗪（以游离碱计）", "en": "doxazosin (as free base)" }, "value": 2, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、加量步骤或与 CARDURA XL 的换算值", "en": "labelled amount per tablet; not an individual's tablet count, titration step or a conversion to CARDURA XL" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-02", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "current_regulatory_listing_not_live_stock", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "白色", "en": "white" }, "shape": { "zh": "长圆形、有刻痕，约 9 mm", "en": "oblong and scored, approximately 9 mm" }, "imprint": "CN2 / VLE", "scoreStatus": "scored_not_personal_split_permission", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_cf8675a49c7b1598", "label": "DailyMed（NLM）：CARDURA 多沙唑嗪当前美国品牌标签、患者信息及四个 100 片瓶装面板", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=5e1f5e49-2da1-43ab-9795-228a8bcc5a82", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-cardura-doxazosin-4mg-100-tablet-bottle-ndc-5815107601", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国品牌标签（患者信息修订 2023-10；当前 SPL 2026-07-16 发布）", "en": "Current U.S. DailyMed brand label (patient information revised Oct 2023; current SPL published 16 Jul 2026)" }, "dosageForm": { "zh": "CARDURA 多沙唑嗪普通口服片", "en": "CARDURA doxazosin immediate-release oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 58151-076-01", "pouchCode": null, "applicationNumber": "NDA 019668", "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片多沙唑嗪 4 mg；100 片瓶装", "en": "Doxazosin 4 mg per tablet; 100-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=image-06.jpg&setid=5e1f5e49-2da1-43ab-9795-228a8bcc5a82", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "多沙唑嗪（以游离碱计）", "en": "doxazosin (as free base)" }, "value": 4, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、加量步骤或与 CARDURA XL 的换算值", "en": "labelled amount per tablet; not an individual's tablet count, titration step or a conversion to CARDURA XL" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-02", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "current_regulatory_listing_not_live_stock", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "白色", "en": "white" }, "shape": { "zh": "菱形、有刻痕，约 12 mm", "en": "rhombus-shaped and scored, approximately 12 mm" }, "imprint": "CN4 / VLE", "scoreStatus": "scored_not_personal_split_permission", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_cf8675a49c7b1598", "label": "DailyMed（NLM）：CARDURA 多沙唑嗪当前美国品牌标签、患者信息及四个 100 片瓶装面板", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=5e1f5e49-2da1-43ab-9795-228a8bcc5a82", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-cardura-doxazosin-8mg-100-tablet-bottle-ndc-5815107701", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国品牌标签（患者信息修订 2023-10；当前 SPL 2026-07-16 发布）", "en": "Current U.S. DailyMed brand label (patient information revised Oct 2023; current SPL published 16 Jul 2026)" }, "dosageForm": { "zh": "CARDURA 多沙唑嗪普通口服片", "en": "CARDURA doxazosin immediate-release oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 58151-077-01", "pouchCode": null, "applicationNumber": "NDA 019668", "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片多沙唑嗪 8 mg；100 片瓶装", "en": "Doxazosin 8 mg per tablet; 100-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=image-07.jpg&setid=5e1f5e49-2da1-43ab-9795-228a8bcc5a82", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "多沙唑嗪（以游离碱计）", "en": "doxazosin (as free base)" }, "value": 8, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、加量步骤或与 CARDURA XL 的换算值", "en": "labelled amount per tablet; not an individual's tablet count, titration step or a conversion to CARDURA XL" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-02", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "current_regulatory_listing_not_live_stock", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "白色", "en": "white" }, "shape": { "zh": "胶囊形、有刻痕，约 12 mm", "en": "capsule-shaped and scored, approximately 12 mm" }, "imprint": "CN8 / VLE", "scoreStatus": "scored_not_personal_split_permission", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_cf8675a49c7b1598", "label": "DailyMed（NLM）：CARDURA 多沙唑嗪当前美国品牌标签、患者信息及四个 100 片瓶装面板", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=5e1f5e49-2da1-43ab-9795-228a8bcc5a82", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-cardura-doxazosin-1mg-100-tablet-bottle-ndc-5815107401", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=image-04.jpg&setid=5e1f5e49-2da1-43ab-9795-228a8bcc5a82", "alt": "CARDURA 多沙唑嗪 1 mg、NDC 58151-074-01、100 片瓶装的 DailyMed 官方标签面板", "archiveMarket": "美国", "labelVersion": "DailyMed 当前美国品牌标签（2026-07-16 发布）", "presentation": "1 mg：白色圆形、约 7 mm、无刻痕，CN1 / VLE；NDC 58151-074-01，100 片瓶装。另有 2、4、8 mg 当前准确包装，必须按 NDC 分开核对。", "notice": "此图只对应美国 NDC 58151-074-01 的 1 mg、100 片瓶装，不代表 CARDURA XL、其他国家包装、仿制品或实时库存，也不用于鉴定真伪。", "source": { "id": "src_cf8675a49c7b1598", "label": "DailyMed（NLM）：CARDURA 多沙唑嗪当前美国品牌标签、患者信息及四个 100 片瓶装面板", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=5e1f5e49-2da1-43ab-9795-228a8bcc5a82", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "CARDURA 说明书放大阅读：分清每片 mg、整瓶片数、普通片与 CARDURA XL", "en": "CARDURA enlarged label: separate per-tablet mg, bottle count, immediate-release tablets and CARDURA XL" }, "summary": { "zh": "1、2、4、8 mg 是每片多沙唑嗪标示量；100 Tablets 是整瓶片数。CARDURA XL 的 4/8 mg 是另一缓释产品，不能因为同成分同数字就自行替换。", "en": "The 1, 2, 4 and 8 mg figures are labelled doxazosin per tablet; 100 Tablets is the bottle count. CARDURA XL 4/8 mg is a separate extended-release product and cannot be self-substituted because ingredient and number match." }, "checks": [ { "zh": "标签警示站立性低血压、头晕和晕厥，特别是在开始、增加规格或中断后恢复时。老人、已有跌倒或同时使用其他降压药者应优先带完整药单核对；网页不生成恢复或加量方案。", "en": "The label warns about postural hypotension, dizziness and syncope, particularly when starting, increasing a strength or resuming after interruption. Older adults, people with falls or another blood-pressure medicine require priority full-list review; the site generates no restart or titration plan." }, { "zh": "CIALIS、VIAGRA 等 PDE-5 抑制剂与 CARDURA 同用可叠加降压并引起症状性低血压；强 CYP3A 抑制剂也可能增加暴露。不要自己错开、减半或停掉其中一盒。", "en": "PDE-5 inhibitors such as CIALIS or VIAGRA can add to blood-pressure lowering and cause symptomatic hypotension with CARDURA; strong CYP3A inhibitors may also increase exposure. Do not self-separate, halve or stop a pack." }, { "zh": "准备白内障手术时，应主动告知眼科团队现在或过去使用过 CARDURA/其他 α1 阻滞剂。标签并不支持患者为此自行停药。", "en": "Before cataract surgery, tell the eye team about current or previous CARDURA/other alpha-1 blocker use. The label does not support self-stopping for this reason." }, { "zh": "2、4、8 mg 片有刻痕，但刻痕只是准确产品的外观线索，不是网页允许个人分片、改变剂量或替代另一规格的指令。", "en": "The 2, 4 and 8 mg tablets are scored, but the score is an appearance clue for the exact product—not website permission to split, change an amount or replace another strength." } ], "source": { "id": "src_cf8675a49c7b1598", "label": "DailyMed（NLM）：CARDURA 多沙唑嗪当前美国品牌标签、患者信息及四个 100 片瓶装面板", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=5e1f5e49-2da1-43ab-9795-228a8bcc5a82", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "多沙唑嗪怎样起作用：阻断 α1 肾上腺素能受体，影响前列腺/膀胱颈平滑肌张力与外周血管阻力", "en": "How doxazosin works: alpha-1 adrenergic blockade affects prostate/bladder-neck smooth-muscle tone and systemic vascular resistance" }, "summary": { "zh": "当前标签说明，阻断前列腺基质、包膜与膀胱颈的 α1 受体可降低尿道阻力；在高血压场景，选择性 α1 阻断降低全身血管阻力。一个机制可关联两类标签用途，但不能根据症状、血压或前列腺大小自行选择规格或与其他 α 阻滞剂叠加。", "en": "The current label explains that alpha-1 blockade in prostatic stroma, capsule and bladder neck can reduce urethral resistance, while selective alpha-1 blockade in hypertension reduces systemic vascular resistance. One mechanism can relate to two labelled settings, but symptoms, blood pressure or prostate size do not permit self-selection of strength or combination with another alpha blocker." }, "checks": [ { "zh": "CARDURA、FLOMAX、MINIPRESS 与 HYTRIN 不是同一种药；共同的 α 阻滞相关机制不建立 mg 换算、轮换或叠加规则。", "en": "CARDURA, FLOMAX, MINIPRESS and HYTRIN are not one medicine. A related alpha-blocker mechanism does not establish milligram conversion, alternation or combination." }, { "zh": "CARDURA 普通片与 CARDURA XL 缓释片的释放结构、NDA 和准确包装不同。XL 标签还说明可能排出看似药片的空壳；这不能套用到普通片，也不能自行压碎缓释片。", "en": "CARDURA immediate-release and CARDURA XL have different release structures, NDAs and exact packs. The XL label also explains that an empty shell may appear in stool; this does not apply to immediate-release tablets or permit crushing the extended-release tablet." }, { "zh": "作用机理不能替代完整药单与个体评估。老人出现站立不稳、晕厥、跌倒，或同用降压药、PDE-5 抑制剂时，应及时核对而不是自行停换。", "en": "Mechanism does not replace complete-list and individual review. Unsteadiness on standing, syncope or a fall in an older adult, or co-use with blood-pressure or PDE-5 medicines, requires timely review rather than self-stopping or switching." } ], "source": { "id": "src_cf8675a49c7b1598", "label": "DailyMed（NLM）：CARDURA 多沙唑嗪当前美国品牌标签、患者信息及四个 100 片瓶装面板", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=5e1f5e49-2da1-43ab-9795-228a8bcc5a82", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "CARDURA", "generic": "多沙唑嗪普通片", "dosageFormClass": "多沙唑嗪普通口服片。CARDURA XL 是 4 mg、8 mg 缓释片，使用不同 NDA、缓释结构、包装与说明书；即使成分和 mg 相同，也不能自行一比一替换、掰碎或拼接。" }, "labelSource": { "id": "src_cf8675a49c7b1598", "label": "DailyMed（NLM）：CARDURA 多沙唑嗪当前美国品牌标签、患者信息及四个 100 片瓶装面板", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=5e1f5e49-2da1-43ab-9795-228a8bcc5a82", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, "productRoutes": [ { "source": { "id": "src_cf8675a49c7b1598", "label": "DailyMed（NLM）：CARDURA 多沙唑嗪当前美国品牌标签、患者信息及四个 100 片瓶装面板", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=5e1f5e49-2da1-43ab-9795-228a8bcc5a82", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-09-02", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_c95032586bca0c04", "label": "DailyMed（NLM）：CARDURA XL 多沙唑嗪缓释片当前美国品牌标签（仅用于剂型边界）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=355bcdce-0481-48ba-8ebd-2009106aaf77", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-09-02", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-09-02", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "CARDURA 是多沙唑嗪普通片品牌档案，标签涉及良性前列腺增生症状与高血压。1/2/4/8 mg 是每片含量，100 Tablets 是整瓶片数，不是个人片数。老人或多药使用者尤其要核对站立性低血压、晕厥、跌倒、PDE-5 抑制剂、其他降压药、强 CYP3A 抑制剂和白内障手术信息；网页不替个人决定规格、次数或换药。", "history": "CARDURA 的美国初始批准年份为 1990。FDA 2009 年补充批准函确认 NDA 019668 下 1、2、4、8 mg 片；当前 DailyMed 品牌标签的患者信息修订于 2023-10，当前 SPL 于 2026-07-16 发布，并展示四个 Viatris 100 片瓶装。CARDURA XL 另属 NDA 021269，不能合并为同一剂型。", "sourceDocuments": [ { "id": "src_cf8675a49c7b1598", "label": "DailyMed（NLM）：CARDURA 多沙唑嗪当前美国品牌标签、患者信息及四个 100 片瓶装面板", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=5e1f5e49-2da1-43ab-9795-228a8bcc5a82", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, { "id": "src_c95032586bca0c04", "label": "DailyMed（NLM）：CARDURA XL 多沙唑嗪缓释片当前美国品牌标签（仅用于剂型边界）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=355bcdce-0481-48ba-8ebd-2009106aaf77", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, { "id": "src_c14c1243de3a5757", "label": "FDA：CARDURA 多沙唑嗪片 NDA 019668/S-021 补充批准函（1、2、4、8 mg）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019668s021ltr.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_regulatory_document", "documentKind": "regulatory_approval_letter", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" } ], "applicationNumber": "NDA 019668", "approvalTimeline": [ { "date": "1990", "title": { "zh": "CARDURA 美国初始批准", "en": "Initial U.S. approval of CARDURA" }, "detail": { "zh": "当前 DailyMed 标签列示的初始批准年份。", "en": "Initial approval year stated by the current DailyMed label." }, "source": { "id": "src_cf8675a49c7b1598", "label": "DailyMed（NLM）：CARDURA 多沙唑嗪当前美国品牌标签、患者信息及四个 100 片瓶装面板", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=5e1f5e49-2da1-43ab-9795-228a8bcc5a82", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" } }, { "date": "2009-07-08", "title": { "zh": "FDA 批准补充标签", "en": "FDA approved a supplemental label" }, "detail": { "zh": "补充批准函确认 1、2、4、8 mg 片，并增加 PDE-5 抑制剂相关低血压信息。", "en": "The supplement letter confirms 1, 2, 4 and 8 mg tablets and adds hypotension information for PDE-5 inhibitors." }, "source": { "id": "src_c14c1243de3a5757", "label": "FDA：CARDURA 多沙唑嗪片 NDA 019668/S-021 补充批准函（1、2、4、8 mg）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019668s021ltr.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_regulatory_document", "documentKind": "regulatory_approval_letter", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" } }, { "date": "2026-07-16", "title": { "zh": "当前 DailyMed SPL 发布", "en": "Current DailyMed SPL published" }, "detail": { "zh": "当前四个 Viatris 品牌瓶装与 2023-10 患者信息可公开阅读。", "en": "The current four Viatris brand bottles and Oct 2023 patient information are publicly readable." }, "source": { "id": "src_cf8675a49c7b1598", "label": "DailyMed（NLM）：CARDURA 多沙唑嗪当前美国品牌标签、患者信息及四个 100 片瓶装面板", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=5e1f5e49-2da1-43ab-9795-228a8bcc5a82", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "当前公开品牌标签", "en": "Current public brand label" }, "detail": { "zh": "NDA 019668；1、2、4、8 mg 普通片，四个 100 片瓶装。", "en": "NDA 019668; 1, 2, 4 and 8 mg immediate-release tablets in four 100-tablet bottles." } }, { "market": { "zh": "美国以外市场", "en": "Markets outside the United States" }, "status": { "zh": "本档案未确认当地商品名、包装或供应", "en": "Local brand, pack and supply are not established by this dossier" }, "detail": { "zh": "“可多华”等名称须与当地药监记录、说明书和手中药盒逐项核对。", "en": "Names such as 可多华 require item-by-item checking against the local regulator, leaflet and pack in hand." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "CARDURA 4 mg 能直接换成 CARDURA XL 4 mg 吗？", "en": "Can CARDURA 4 mg be directly replaced by CARDURA XL 4 mg?" }, "answer": { "zh": "不能从共同成分和相同数字作这种结论。它们属于不同 NDA、释放结构和说明书；请让开方团队按准确产品、用途、血压和完整药单判断，不要自行一比一替换。", "en": "No conclusion can be drawn from a shared ingredient and matching number. They have different NDAs, release structures and labels; the prescriber must review the exact products, purpose, blood pressure and full medicine list. Do not self-substitute one-for-one." } }, { "question": { "zh": "药片有刻痕，是不是都可以吃半片？", "en": "Does a score mean every tablet can be taken as a half?" }, "answer": { "zh": "不是。刻痕可帮助识别准确产品，但能否分片还取决于处方、产品说明书、分割均匀性和个人方案。1 mg 当前片无刻痕；任何规格都不要仅凭刻痕自行减半。", "en": "No. A score can help identify an exact product, but splitting still depends on the prescription, product label, dose uniformity and individual plan. The current 1 mg tablet is unscored; do not self-halve any strength from the score alone." } }, { "question": { "zh": "同时有 FLOMAX、CARDURA、CIALIS 或其他降压药怎么办？", "en": "What if FLOMAX, CARDURA, CIALIS or another blood-pressure medicine are on the same list?" }, "answer": { "zh": "不要自行删掉或错开任何一盒。共同用途、α 阻滞或降压作用可能增加头晕、站立性低血压、晕厥与跌倒风险，也可能是专业人员有意安排；只有准确药盒、处方、血压和完整药单能判断。", "en": "Do not remove or separate a pack yourself. Shared uses, alpha blockade or blood-pressure effects may increase dizziness, orthostatic hypotension, syncope and falls, or may be intentionally prescribed. Only exact packs, prescriptions, blood pressure and the complete list can establish this." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "dose-unit-literacy", "same-class-is-not-same-medicine", "dosage-forms-are-part-of-medicine-identity" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/cardura-doxazosin/", "en": "https://origindrug.com/en/drugs/cardura-doxazosin/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "lotensin-benazepril", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-09-02", "status": "published_traceable_archive" }, "names": { "brand": "LOTENSIN", "generic": "盐酸贝那普利普通片", "aliases": [ "Lotensin", "benazepril", "benazepril hydrochloride", "贝那普利", "盐酸贝那普利", "洛汀新", "benazepril tablets", "盐酸贝那普利片", "LOTENSIN", "NDA 019851", "30698-448-01", "30698-449-01", "30698-450-01", "LOTENSIN 10", "LOTENSIN 20", "LOTENSIN 40" ], "marketBrandNames": [ { "name": "LOTENSIN", "market": { "zh": "美国", "en": "United States" }, "evidenceStatus": "current_regulatory_record", "note": { "zh": "NDA 019851；当前品牌标签列 10、20、40 mg 普通片。监管标签不等于实时供应。", "en": "NDA 019851; the current brand label lists 10, 20 and 40 mg immediate-release tablets. A regulatory label is not live supply." }, "source": { "id": "src_97b68c48cf7b556c", "label": "DailyMed（NLM）：LOTENSIN 贝那普利当前美国品牌标签、患者阅读内容及三个 100 片瓶装面板", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=2abb091b-a53e-46b0-9b84-e5ee8f2bdd8e", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" } } ], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "心血管", "sourceArchiveMarket": "美国 DailyMed 当前 LOTENSIN 品牌标签列 10、20、40 mg 普通片三个 100 片瓶装，均归入 NDA 019851。历史审批文件还出现 5 mg，但当前品牌标签的剂型强度和包装面板未列 5 mg；网页不把历史规格改写为当前品牌包装或实时供应。", "dosageFormClass": "盐酸贝那普利普通口服片。LOTENSIN HCT 另含氢氯噻嗪，LOTREL 另含氨氯地平；共同品牌或成分词根不建立一比一替换、叠加或 mg 换算。", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "1991（美国初始批准年份）", "archiveSponsorText": "Validus Pharmaceuticals LLC（当前美国品牌标签包装方）" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [ "LOTENSIN", "Lotensin benazepril", "盐酸贝那普利片", "贝那普利片", "洛汀新" ], "excludedProductCues": [ "LOTENSIN HCT", "benazepril hydrochloride hydrochlorothiazide", "贝那普利氢氯噻嗪", "LOTREL", "amlodipine benazepril", "氨氯地平贝那普利" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-lotensin-benazepril-10mg-100-tablet-bottle-ndc-3069844801", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国品牌标签（SPL v10；2025-09-30 更新，2025-10-02 发布）", "en": "Current U.S. DailyMed brand label (SPL v10; updated 30 Sep and published 2 Oct 2025)" }, "dosageForm": { "zh": "LOTENSIN 盐酸贝那普利普通口服片", "en": "LOTENSIN benazepril hydrochloride immediate-release oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 30698-448-01", "pouchCode": null, "applicationNumber": "NDA 019851", "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片盐酸贝那普利 10 mg；100 片瓶装", "en": "Benazepril hydrochloride 10 mg per tablet; 100-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=lotensin-02.jpg&setid=2abb091b-a53e-46b0-9b84-e5ee8f2bdd8e", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "盐酸贝那普利", "en": "benazepril hydrochloride" }, "value": 10, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数，也不是与 LOTENSIN HCT、LOTREL 或其他 ACE 抑制剂的换算值", "en": "labelled amount per tablet; not an individual's tablet count or a conversion to LOTENSIN HCT, LOTREL or another ACE inhibitor" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-02", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "current_regulatory_listing_not_live_stock", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "深黄色", "en": "dark yellow" }, "shape": { "zh": "圆形、约 8 mm；当前标签正文列为无刻痕", "en": "round, approximately 8 mm; current label text lists no score" }, "imprint": "LOTENSIN / 10", "scoreStatus": "unscored_no_split_permission_inferred", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_97b68c48cf7b556c", "label": "DailyMed（NLM）：LOTENSIN 贝那普利当前美国品牌标签、患者阅读内容及三个 100 片瓶装面板", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=2abb091b-a53e-46b0-9b84-e5ee8f2bdd8e", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-lotensin-benazepril-20mg-100-tablet-bottle-ndc-3069844901", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国品牌标签（SPL v10；2025-09-30 更新，2025-10-02 发布）", "en": "Current U.S. DailyMed brand label (SPL v10; updated 30 Sep and published 2 Oct 2025)" }, "dosageForm": { "zh": "LOTENSIN 盐酸贝那普利普通口服片", "en": "LOTENSIN benazepril hydrochloride immediate-release oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 30698-449-01", "pouchCode": null, "applicationNumber": "NDA 019851", "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片盐酸贝那普利 20 mg；100 片瓶装", "en": "Benazepril hydrochloride 20 mg per tablet; 100-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=lotensin-03.jpg&setid=2abb091b-a53e-46b0-9b84-e5ee8f2bdd8e", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "盐酸贝那普利", "en": "benazepril hydrochloride" }, "value": 20, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数，也不是与 LOTENSIN HCT、LOTREL 或其他 ACE 抑制剂的换算值", "en": "labelled amount per tablet; not an individual's tablet count or a conversion to LOTENSIN HCT, LOTREL or another ACE inhibitor" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-02", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "current_regulatory_listing_not_live_stock", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "粉红色", "en": "pink" }, "shape": { "zh": "圆形、约 8 mm；当前标签正文列为无刻痕", "en": "round, approximately 8 mm; current label text lists no score" }, "imprint": "LOTENSIN / 20", "scoreStatus": "unscored_no_split_permission_inferred", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_97b68c48cf7b556c", "label": "DailyMed（NLM）：LOTENSIN 贝那普利当前美国品牌标签、患者阅读内容及三个 100 片瓶装面板", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=2abb091b-a53e-46b0-9b84-e5ee8f2bdd8e", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-lotensin-benazepril-40mg-100-tablet-bottle-ndc-3069845001", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国品牌标签（SPL v10；2025-09-30 更新，2025-10-02 发布）", "en": "Current U.S. DailyMed brand label (SPL v10; updated 30 Sep and published 2 Oct 2025)" }, "dosageForm": { "zh": "LOTENSIN 盐酸贝那普利普通口服片", "en": "LOTENSIN benazepril hydrochloride immediate-release oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 30698-450-01", "pouchCode": null, "applicationNumber": "NDA 019851", "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片盐酸贝那普利 40 mg；100 片瓶装", "en": "Benazepril hydrochloride 40 mg per tablet; 100-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=lotensin-04.jpg&setid=2abb091b-a53e-46b0-9b84-e5ee8f2bdd8e", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "盐酸贝那普利", "en": "benazepril hydrochloride" }, "value": 40, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数，也不是与 LOTENSIN HCT、LOTREL 或其他 ACE 抑制剂的换算值", "en": "labelled amount per tablet; not an individual's tablet count or a conversion to LOTENSIN HCT, LOTREL or another ACE inhibitor" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-02", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "current_regulatory_listing_not_live_stock", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "深玫瑰红色", "en": "dark rose" }, "shape": { "zh": "圆形、约 8 mm；当前标签正文列为无刻痕", "en": "round, approximately 8 mm; current label text lists no score" }, "imprint": "LOTENSIN / 40", "scoreStatus": "unscored_no_split_permission_inferred", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_97b68c48cf7b556c", "label": "DailyMed（NLM）：LOTENSIN 贝那普利当前美国品牌标签、患者阅读内容及三个 100 片瓶装面板", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=2abb091b-a53e-46b0-9b84-e5ee8f2bdd8e", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-lotensin-benazepril-10mg-100-tablet-bottle-ndc-3069844801", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=lotensin-02.jpg&setid=2abb091b-a53e-46b0-9b84-e5ee8f2bdd8e", "alt": "LOTENSIN 盐酸贝那普利 10 mg、NDC 30698-448-01、100 片瓶装的 DailyMed 官方标签面板", "archiveMarket": "美国", "labelVersion": "DailyMed 当前美国品牌标签（2025-10-02 发布）", "presentation": "10 mg：深黄色圆形、约 8 mm、LOTENSIN / 10；NDC 30698-448-01，100 片瓶装。另有 20、40 mg 当前准确包装，必须按 NDC 分开核对。", "notice": "此图只对应美国 NDC 30698-448-01 的 10 mg、100 片瓶装，不代表 LOTENSIN HCT、LOTREL、历史 5 mg、其他市场包装或实时库存，也不用于鉴定真伪。", "source": { "id": "src_97b68c48cf7b556c", "label": "DailyMed（NLM）：LOTENSIN 贝那普利当前美国品牌标签、患者阅读内容及三个 100 片瓶装面板", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=2abb091b-a53e-46b0-9b84-e5ee8f2bdd8e", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "LOTENSIN 说明书放大阅读：分清每片 mg、整瓶片数、单方与两个复方", "en": "LOTENSIN enlarged label: separate per-tablet mg, bottle count, single ingredient and two combinations" }, "summary": { "zh": "10、20、40 mg 是每片盐酸贝那普利标示量；100 Tablets 是整瓶片数。LOTENSIN HCT 另含氢氯噻嗪，LOTREL 另含氨氯地平，不能从共同词根或总毫克数自行拼接、叠加或替换。", "en": "The 10, 20 and 40 mg figures are labelled benazepril hydrochloride per tablet; 100 Tablets is the bottle count. LOTENSIN HCT also contains hydrochlorothiazide and LOTREL also contains amlodipine, so shared name stems or total milligrams do not permit self-assembly, combination or substitution." }, "checks": [ { "zh": "标签有胎儿毒性黑框警示。若已怀孕、可能怀孕或计划怀孕，应立即联系开方团队；网页不生成继续、暂停或替代方案。", "en": "The label carries a boxed warning for fetal toxicity. Contact the prescriber promptly for pregnancy, possible pregnancy or pregnancy planning; the site generates no continuation, stopping or substitution plan." }, { "zh": "面、唇、舌或喉咙肿胀，尤其伴呼吸或吞咽困难，属于需要紧急处理的血管性水肿信号；不要等待网页判断。", "en": "Swelling of the face, lips, tongue or throat—especially with breathing or swallowing difficulty—is an emergency angioedema signal. Do not wait for a website assessment." }, { "zh": "ENTRESTO 含沙库巴曲/缬沙坦，标签规定与贝那普利等 ACE 抑制剂转换有 36 小时边界；不要自行安排错开、停药或换药。", "en": "ENTRESTO contains sacubitril/valsartan, and the label specifies a 36-hour boundary when switching to or from an ACE inhibitor such as benazepril. Do not self-schedule spacing, stopping or switching." }, { "zh": "补钾、含钾代盐、保钾利尿药、另一种 ACEI/ARB、NSAID、锂或利尿剂同处药单时，应优先核对肾功能、血钾、低血压与完整药单；老人脱水、站立不稳或跌倒更应及时核对。", "en": "Potassium supplements or salt substitutes, a potassium-sparing diuretic, another ACE inhibitor/ARB, NSAID, lithium or a diuretic on the same list requires priority review of kidney function, potassium, hypotension and the complete medicine list. Dehydration, unsteadiness or a fall in an older adult needs timely review." } ], "source": { "id": "src_97b68c48cf7b556c", "label": "DailyMed（NLM）：LOTENSIN 贝那普利当前美国品牌标签、患者阅读内容及三个 100 片瓶装面板", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=2abb091b-a53e-46b0-9b84-e5ee8f2bdd8e", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "贝那普利怎样起作用：抑制 ACE，减少血管紧张素 II，并影响缓激肽通路", "en": "How benazepril works: ACE inhibition reduces angiotensin II and affects the bradykinin pathway" }, "summary": { "zh": "贝那普利在体内转为活性代谢物贝那普利拉，抑制 ACE 后减少血管紧张素 II 形成并降低醛固酮相关作用。ACE 也参与缓激肽分解，这有助于理解为何咳嗽和血管性水肿需要被认真识别；机制不能替个人决定药物或剂量。", "en": "Benazepril is converted to the active metabolite benazeprilat. ACE inhibition reduces formation of angiotensin II and related aldosterone effects. ACE also participates in bradykinin breakdown, which helps explain why cough and angioedema require attention; mechanism cannot choose a medicine or dose for an individual." }, "checks": [ { "zh": "LOTENSIN、ZESTRIL、VASOTEC、ALTACE、CAPOTEN 和 COVERSYL 不是同一种药；共同 ACE 抑制机制不建立 mg 换算、轮换或叠加规则。", "en": "LOTENSIN, ZESTRIL, VASOTEC, ALTACE, CAPOTEN and COVERSYL are not one medicine. A shared ACE-inhibitor mechanism does not establish milligram conversion, alternation or combination." }, { "zh": "与 ARB、阿利吉仑或另一种肾素-血管紧张素系统药物共同出现，可能增加低血压、高钾和肾功能受损风险；共同机制不是更强或更适合的证明。", "en": "Co-listing an ARB, aliskiren or another renin-angiotensin-system medicine may increase hypotension, hyperkalaemia and kidney-impairment risk. A shared mechanism is not proof of greater benefit or suitability." }, { "zh": "干咳可以与 ACE 抑制剂有关，但老人呼吸困难、喉头紧、面唇舌肿胀不能简单当作普通咳嗽，应按紧急信号处理。", "en": "A dry cough can be associated with ACE inhibitors, but breathing difficulty, throat tightness or face/lip/tongue swelling in an older adult must not be dismissed as an ordinary cough and requires emergency action." } ], "source": { "id": "src_97b68c48cf7b556c", "label": "DailyMed（NLM）：LOTENSIN 贝那普利当前美国品牌标签、患者阅读内容及三个 100 片瓶装面板", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=2abb091b-a53e-46b0-9b84-e5ee8f2bdd8e", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "LOTENSIN", "generic": "盐酸贝那普利普通片", "dosageFormClass": "盐酸贝那普利普通口服片。LOTENSIN HCT 另含氢氯噻嗪，LOTREL 另含氨氯地平；共同品牌或成分词根不建立一比一替换、叠加或 mg 换算。" }, "labelSource": { "id": "src_97b68c48cf7b556c", "label": "DailyMed（NLM）：LOTENSIN 贝那普利当前美国品牌标签、患者阅读内容及三个 100 片瓶装面板", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=2abb091b-a53e-46b0-9b84-e5ee8f2bdd8e", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, "productRoutes": [ { "source": { "id": "src_97b68c48cf7b556c", "label": "DailyMed（NLM）：LOTENSIN 贝那普利当前美国品牌标签、患者阅读内容及三个 100 片瓶装面板", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=2abb091b-a53e-46b0-9b84-e5ee8f2bdd8e", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-09-02", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-09-02", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "LOTENSIN 是盐酸贝那普利单方普通片品牌档案。10/20/40 mg 是每片含量，100 Tablets 是整瓶片数，不是个人片数。老人或多药使用者应优先核对站立性低血压/跌倒、肾功能、血钾、补钾与含钾代盐、利尿剂、NSAID 止痛药、锂、其他 ACEI/ARB 和 ENTRESTO；网页不替个人决定规格、次数、停药或换药。", "history": "LOTENSIN 的美国初始批准年份为 1991。FDA 2012 年补充批准函同时列出 LOTENSIN 单方与 LOTENSIN HCT 复方并分别绑定 NDA，说明共同品牌词根不能合并产品。当前 DailyMed SPL v10 于 2025-10-02 发布，列示三个 Validus 100 片瓶装。", "sourceDocuments": [ { "id": "src_97b68c48cf7b556c", "label": "DailyMed（NLM）：LOTENSIN 贝那普利当前美国品牌标签、患者阅读内容及三个 100 片瓶装面板", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=2abb091b-a53e-46b0-9b84-e5ee8f2bdd8e", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, { "id": "src_bf47012f7d7dd413", "label": "FDA：LOTENSIN 贝那普利 NDA 019851/S-043 与 LOTENSIN HCT 分剂型补充批准函（2012）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019851s043%2C020033s045ltr.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_regulatory_document", "documentKind": "regulatory_approval_letter", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" } ], "applicationNumber": "NDA 019851", "approvalTimeline": [ { "date": "1991", "title": { "zh": "LOTENSIN 美国初始批准", "en": "Initial U.S. approval of LOTENSIN" }, "detail": { "zh": "当前 DailyMed 标签列示的初始批准年份。", "en": "Initial approval year stated by the current DailyMed label." }, "source": { "id": "src_97b68c48cf7b556c", "label": "DailyMed（NLM）：LOTENSIN 贝那普利当前美国品牌标签、患者阅读内容及三个 100 片瓶装面板", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=2abb091b-a53e-46b0-9b84-e5ee8f2bdd8e", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" } }, { "date": "2012-01-30", "title": { "zh": "FDA 批准胎儿毒性等标签补充", "en": "FDA approved a fetal-toxicity and related labelling supplement" }, "detail": { "zh": "补充批准函分别列出 LOTENSIN NDA 019851 与 LOTENSIN HCT NDA 020033，并更新胎儿毒性警示。", "en": "The supplement letter separately lists LOTENSIN NDA 019851 and LOTENSIN HCT NDA 020033 and updates fetal-toxicity labelling." }, "source": { "id": "src_bf47012f7d7dd413", "label": "FDA：LOTENSIN 贝那普利 NDA 019851/S-043 与 LOTENSIN HCT 分剂型补充批准函（2012）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019851s043%2C020033s045ltr.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_regulatory_document", "documentKind": "regulatory_approval_letter", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" } }, { "date": "2025-10-02", "title": { "zh": "当前 DailyMed SPL 发布", "en": "Current DailyMed SPL published" }, "detail": { "zh": "当前三个 Validus 品牌瓶装与说明书可公开阅读。", "en": "The current three Validus brand bottles and label are publicly readable." }, "source": { "id": "src_97b68c48cf7b556c", "label": "DailyMed（NLM）：LOTENSIN 贝那普利当前美国品牌标签、患者阅读内容及三个 100 片瓶装面板", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=2abb091b-a53e-46b0-9b84-e5ee8f2bdd8e", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "当前公开品牌标签", "en": "Current public brand label" }, "detail": { "zh": "NDA 019851；10、20、40 mg 普通片，三个 100 片瓶装。", "en": "NDA 019851; 10, 20 and 40 mg immediate-release tablets in three 100-tablet bottles." } }, { "market": { "zh": "美国以外市场", "en": "Markets outside the United States" }, "status": { "zh": "本档案未确认当地商品名、包装或供应", "en": "Local brand, pack and supply are not established by this dossier" }, "detail": { "zh": "“洛汀新”等名称须与当地药监记录、说明书和手中药盒逐项核对。", "en": "Names such as 洛汀新 require item-by-item checking against the local regulator, leaflet and pack in hand." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "LOTENSIN、LOTENSIN HCT 和 LOTREL 是一回事吗？", "en": "Are LOTENSIN, LOTENSIN HCT and LOTREL the same product?" }, "answer": { "zh": "不是。LOTENSIN 是贝那普利单方，LOTENSIN HCT 再加氢氯噻嗪，LOTREL 再加氨氯地平；共同成分可能造成重复，不能按品牌词根自行叠加或换算。", "en": "No. LOTENSIN is benazepril alone, LOTENSIN HCT adds hydrochlorothiazide, and LOTREL adds amlodipine. A shared ingredient may create duplication and does not permit self-combination or conversion from brand stems." } }, { "question": { "zh": "标签有历史 5 mg，为什么当前包装只有 10、20、40 mg？", "en": "Why do historical records mention 5 mg while current packs show 10, 20 and 40 mg?" }, "answer": { "zh": "历史审批记录与当前公开标签是不同时间证据。当前标签的剂型强度和三个包装面板只列 10、20、40 mg；网页不把历史 5 mg 改写成当前品牌供应。", "en": "Historical approval records and a current public label are different time-bounded evidence. The current dosage-form section and three pack panels list only 10, 20 and 40 mg; the site does not rewrite historical 5 mg as current brand supply." } }, { "question": { "zh": "同时有 ENTRESTO、补钾、布洛芬或另一种降压药怎么办？", "en": "What if ENTRESTO, potassium, ibuprofen or another blood-pressure medicine is on the same list?" }, "answer": { "zh": "不要自行删药、补药或安排错开。ENTRESTO 与 ACE 抑制剂有 36 小时标签边界；补钾、NSAID、其他 RAS 药物和利尿剂还涉及血钾、肾功能和低血压。请用准确药盒、处方、化验和完整药单让开方团队或药师核对。", "en": "Do not self-remove, add or schedule spacing. ENTRESTO and ACE inhibitors have a 36-hour label boundary; potassium, NSAIDs, other RAS medicines and diuretics also involve potassium, kidney function and hypotension. Have the prescriber or pharmacist review exact packs, prescriptions, laboratory results and the complete medicine list." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "dose-unit-literacy", "same-class-is-not-same-medicine", "interactions-are-not-a-home-scheduling-problem" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/lotensin-benazepril/", "en": "https://origindrug.com/en/drugs/lotensin-benazepril/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "monopril-fosinopril", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-09-13", "status": "published_traceable_archive" }, "names": { "brand": "MONOPRIL", "generic": "福辛普利钠普通口服片", "aliases": [ "Monopril", "fosinopril", "fosinopril sodium", "fosinopril sodium tablets", "福辛普利", "福辛普利钠", "福辛普利钠片", "蒙诺", "MONOPRIL", "NDA 019915", "MONOPRIL 10 mg", "MONOPRIL 20 mg", "MONOPRIL 40 mg" ], "marketBrandNames": [ { "name": "MONOPRIL", "market": { "zh": "美国", "en": "United States" }, "evidenceStatus": "historical_regulatory_record", "note": { "zh": "NDA 019915：10/20/40 mg 历史单方口服片均为 RLD，当前均为 DISCN；监管历史不等于实时供应。", "en": "NDA 019915: historical 10/20/40 mg single-ingredient oral tablets are RLD entries and currently DISCN; regulatory history is not live supply." }, "source": { "id": "src_bab1d3663a3c9c1a", "label": "FDA Orange Book：MONOPRIL（福辛普利钠）NDA 019915 的 10/20/40 mg 历史口服片 RLD 条目；当前均为 DISCN，且非因安全性或有效性撤市", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/approved-drug-products-therapeutic-equivalence-evaluations-orange-book", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_reference", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-13", "reviewedAt": "2026-09-13" } }, { "name": "FOSINOPRIL SODIUM", "market": { "zh": "美国", "en": "United States" }, "evidenceStatus": "dated_regulatory_record", "note": { "zh": "当前可公开阅读的是 Chartwell RX 仿制药标签；不把它改写成 MONOPRIL 原品牌包装。", "en": "The publicly readable current source is a Chartwell RX generic label; it is not rewritten as an original MONOPRIL pack." }, "source": { "id": "src_71530546861c70f2", "label": "DailyMed（NLM）：福辛普利钠普通口服片当前美国公开仿制药说明书（Chartwell RX；2025-11-17 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ff1323cc-7ad8-488d-94a7-a11555db78a7", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-13", "reviewedAt": "2026-09-13" } } ], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "心血管", "sourceArchiveMarket": "FDA Orange Book 的 MONOPRIL NDA 019915 历史单方普通口服片为 10、20、40 mg，均列为 DISCN；数据同时说明并非因安全性或有效性撤市。当前公开阅读来源是 Chartwell RX 的仿制药福辛普利钠片标签，不是 MONOPRIL 原品牌包装、实时库存或其他市场状态。", "dosageFormClass": "福辛普利钠普通口服片。MONOPRIL-HCT 另含氢氯噻嗪；单方与复方、福辛普利与其他 ACE 抑制剂不能仅按共同用途或 mg 自行换算、拼接、叠加或替换。", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "1991（美国 MONOPRIL 初始批准年份）", "archiveSponsorText": "Bristol-Myers Squibb（FDA 历史 NDA/RLD 条目申请主体）；Chartwell RX, LLC（当前公开仿制药标签主体）" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [ "MONOPRIL", "Monopril", "fosinopril sodium tablets", "福辛普利钠片" ], "excludedProductCues": [ "MONOPRIL-HCT", "fosinopril sodium hydrochlorothiazide", "福辛普利钠氢氯噻嗪", "other ACE inhibitors" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "status": "withheld_repackaged_or_non_exact_visual", "title": { "zh": "未展示 MONOPRIL 外观图：历史原研与当前仿制药标签不能混作同一包装", "en": "MONOPRIL image withheld: a historical originator and a current generic label are not one package" }, "summary": { "zh": "本次核验保留了历史 MONOPRIL 的 FDA 产品身份及当前福辛普利钠仿制药公开说明书，但未取得能与 MONOPRIL、特定规格、特定包装和公开一手来源逐一对应的准确外观图。为避免把仿制药、其他市场、历史版本或来源不明图片误作原品牌外观，本页不展示包装图。", "en": "This review retains the historical FDA identity for MONOPRIL and a current public generic fosinopril label, but no exact public image was retained that matches MONOPRIL, one strength, one pack and a primary source one-to-one. To avoid presenting generic, other-market, historical-version or source-uncertain imagery as the originator appearance, this page shows no package image." }, "source": { "id": "src_bab1d3663a3c9c1a", "label": "FDA Orange Book：MONOPRIL（福辛普利钠）NDA 019915 的 10/20/40 mg 历史口服片 RLD 条目；当前均为 DISCN，且非因安全性或有效性撤市", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/approved-drug-products-therapeutic-equivalence-evaluations-orange-book", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_reference", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-13", "reviewedAt": "2026-09-13" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "福辛普利说明书放大阅读：先分清历史品牌、每片 mg、复方与同类药", "en": "Fosinopril enlarged-label reading: first separate historical brand, per-tablet mg, combinations and class medicines" }, "summary": { "zh": "MONOPRIL 历史 10/20/40 mg 是每片福辛普利钠规格；它不是个人片数，也不能与 MONOPRIL-HCT、其他 ACE 抑制剂或 ARB 按数字自行互换。当前公开说明书属于仿制药，需要与手中药盒的成分、剂型、规格、市场和文件版本逐项核对。", "en": "Historical MONOPRIL 10/20/40 mg figures are fosinopril sodium strengths per tablet. They are not an individual's tablet count and cannot be self-interchanged from numbers with MONOPRIL-HCT, another ACE inhibitor or an ARB. The current public leaflet is generic and must be checked item by item against the pack in hand for ingredient, form, strength, market and document version." }, "checks": [ { "zh": "ACE 抑制剂标签有胎儿毒性警示。已怀孕、可能怀孕或计划怀孕时，应立即联系开方团队；网页不生成继续、暂停或替代方案。", "en": "ACE-inhibitor labels carry a fetal-toxicity warning. Contact the prescriber promptly for pregnancy, possible pregnancy or pregnancy planning; this site creates no continuation, stopping or replacement plan." }, { "zh": "面、唇、舌或喉咙肿胀，尤其伴呼吸或吞咽困难，属于需要紧急处理的血管性水肿信号；不要等待网页判断。", "en": "Swelling of the face, lips, tongue or throat—especially with breathing or swallowing difficulty—is an emergency angioedema signal. Do not wait for a website assessment." }, { "zh": "补钾、含钾代盐、保钾利尿药、另一种 ACEI/ARB、NSAID、锂或利尿剂同处药单时，应优先核对血钾、肾功能、低血压与跌倒风险；发现疑似重复时不要自行增减、错开或停药。", "en": "Potassium supplements or salt substitutes, a potassium-sparing diuretic, another ACE inhibitor/ARB, NSAID, lithium or a diuretic on the same list requires priority review of potassium, kidney function, hypotension and fall risk. Do not self-add, reduce, separate or stop when duplication is suspected." } ], "source": { "id": "src_71530546861c70f2", "label": "DailyMed（NLM）：福辛普利钠普通口服片当前美国公开仿制药说明书（Chartwell RX；2025-11-17 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ff1323cc-7ad8-488d-94a7-a11555db78a7", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-13", "reviewedAt": "2026-09-13" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "福辛普利怎样起作用：ACE 抑制与血管紧张素 II／缓激肽通路", "en": "How fosinopril works: ACE inhibition and the angiotensin II/bradykinin pathways" }, "summary": { "zh": "福辛普利在体内转化为有活性的福辛普利拉；ACE 抑制会减少血管紧张素 II 形成并影响醛固酮相关通路。ACE 也参与缓激肽分解，这有助于理解咳嗽和血管性水肿为何需要认真识别；机制不能替个人选择药物或剂量。", "en": "Fosinopril is converted in the body to active fosinoprilat. ACE inhibition reduces angiotensin II formation and affects aldosterone-related pathways. ACE also participates in bradykinin breakdown, which helps explain why cough and angioedema require attention; mechanism cannot choose a medicine or dose for an individual." }, "checks": [ { "zh": "MONOPRIL、LOTENSIN、ZESTRIL、VASOTEC、ALTACE、CAPOTEN 与 COVERSYL 不是同一种药；共同 ACE 抑制机制不建立 mg 换算、轮换或叠加规则。", "en": "MONOPRIL, LOTENSIN, ZESTRIL, VASOTEC, ALTACE, CAPOTEN and COVERSYL are not one medicine. A shared ACE-inhibitor mechanism does not establish milligram conversion, alternation or combination." }, { "zh": "另一种肾素-血管紧张素系统药物同处药单时，可能增加低血压、高钾和肾功能受损风险；共同机制不是更强或更适合的证明。", "en": "Another renin-angiotensin-system medicine on the same list can increase risks of hypotension, hyperkalaemia and kidney impairment. A shared mechanism is not proof of greater benefit or suitability." }, { "zh": "干咳可以与 ACE 抑制剂有关，但呼吸困难、喉头紧、面唇舌肿胀不能简单当作普通咳嗽，应按紧急信号处理。", "en": "A dry cough can be associated with ACE inhibitors, but breathing difficulty, throat tightness or face/lip/tongue swelling must not be dismissed as an ordinary cough and needs emergency action." } ], "source": { "id": "src_71530546861c70f2", "label": "DailyMed（NLM）：福辛普利钠普通口服片当前美国公开仿制药说明书（Chartwell RX；2025-11-17 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ff1323cc-7ad8-488d-94a7-a11555db78a7", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-13", "reviewedAt": "2026-09-13" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "MONOPRIL", "generic": "福辛普利钠普通口服片", "dosageFormClass": "福辛普利钠普通口服片。MONOPRIL-HCT 另含氢氯噻嗪；单方与复方、福辛普利与其他 ACE 抑制剂不能仅按共同用途或 mg 自行换算、拼接、叠加或替换。" }, "labelSource": { "id": "src_71530546861c70f2", "label": "DailyMed（NLM）：福辛普利钠普通口服片当前美国公开仿制药说明书（Chartwell RX；2025-11-17 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ff1323cc-7ad8-488d-94a7-a11555db78a7", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-13", "reviewedAt": "2026-09-13" }, "productRoutes": [ { "source": { "id": "src_71530546861c70f2", "label": "DailyMed（NLM）：福辛普利钠普通口服片当前美国公开仿制药说明书（Chartwell RX；2025-11-17 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ff1323cc-7ad8-488d-94a7-a11555db78a7", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-13", "reviewedAt": "2026-09-13" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-09-13", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-09-13", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "MONOPRIL 是福辛普利钠单方普通口服片的历史美国原研档案。10、20、40 mg 是每片历史标签规格，不是个人片数、减量表或与其他降压药的换算比例。老人和多药使用者应优先让药师或开方团队核对完整药单、血压相关症状、肾功能、血钾、利尿剂、补钾或含钾代盐、NSAID 止痛药、锂、其他 ACEI/ARB 及含沙库巴曲的产品；网页不决定个人剂量、频次、停药或换药。", "history": "FDA Orange Book 记录 MONOPRIL NDA 019915 的 10 mg 与 20 mg 片于 1991 年获批、40 mg 片于 1995 年获批。三个历史 RLD 条目当前均为 DISCN，且记录为非因安全性或有效性撤市。本站仅用当前公开仿制药标签帮助阅读福辛普利钠的药物类别与警戒边界，不把它当作历史 MONOPRIL 品牌的准确包装或供应证明。", "sourceDocuments": [ { "id": "src_bab1d3663a3c9c1a", "label": "FDA Orange Book：MONOPRIL（福辛普利钠）NDA 019915 的 10/20/40 mg 历史口服片 RLD 条目；当前均为 DISCN，且非因安全性或有效性撤市", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/approved-drug-products-therapeutic-equivalence-evaluations-orange-book", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_reference", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-13", "reviewedAt": "2026-09-13" }, { "id": "src_71530546861c70f2", "label": "DailyMed（NLM）：福辛普利钠普通口服片当前美国公开仿制药说明书（Chartwell RX；2025-11-17 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ff1323cc-7ad8-488d-94a7-a11555db78a7", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-13", "reviewedAt": "2026-09-13" } ], "applicationNumber": "NDA 019915（MONOPRIL 历史美国单方产品）；当前公开仿制药标签：DailyMed SETID ff1323cc-7ad8-488d-94a7-a11555db78a7", "approvalTimeline": [ { "date": "1991-05-16", "title": { "zh": "MONOPRIL 10 mg 与 20 mg 美国批准", "en": "U.S. approval of MONOPRIL 10 mg and 20 mg" }, "detail": { "zh": "FDA Orange Book 中 NDA 019915 的两个历史单方口服片 RLD 条目。", "en": "Two historical single-ingredient oral-tablet RLD entries under FDA NDA 019915." }, "source": { "id": "src_bab1d3663a3c9c1a", "label": "FDA Orange Book：MONOPRIL（福辛普利钠）NDA 019915 的 10/20/40 mg 历史口服片 RLD 条目；当前均为 DISCN，且非因安全性或有效性撤市", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/approved-drug-products-therapeutic-equivalence-evaluations-orange-book", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_reference", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-13", "reviewedAt": "2026-09-13" } }, { "date": "1995-03-28", "title": { "zh": "MONOPRIL 40 mg 美国批准", "en": "U.S. approval of MONOPRIL 40 mg" }, "detail": { "zh": "FDA Orange Book 中 NDA 019915 的第三个历史单方口服片 RLD 条目。", "en": "The third historical single-ingredient oral-tablet RLD entry under FDA NDA 019915." }, "source": { "id": "src_bab1d3663a3c9c1a", "label": "FDA Orange Book：MONOPRIL（福辛普利钠）NDA 019915 的 10/20/40 mg 历史口服片 RLD 条目；当前均为 DISCN，且非因安全性或有效性撤市", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/approved-drug-products-therapeutic-equivalence-evaluations-orange-book", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_reference", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-13", "reviewedAt": "2026-09-13" } }, { "date": "2025-11-17", "title": { "zh": "现行公开仿制药说明书发布", "en": "Current public generic label published" }, "detail": { "zh": "Chartwell RX 福辛普利钠片说明书用于阅读现行安全与类别信息，不替代历史 MONOPRIL 包装资料。", "en": "The Chartwell RX fosinopril sodium label supports reading current safety and class information; it does not replace historical MONOPRIL pack evidence." }, "source": { "id": "src_71530546861c70f2", "label": "DailyMed（NLM）：福辛普利钠普通口服片当前美国公开仿制药说明书（Chartwell RX；2025-11-17 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ff1323cc-7ad8-488d-94a7-a11555db78a7", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-13", "reviewedAt": "2026-09-13" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "历史 RLD；当前 DISCN", "en": "Historical RLD; currently DISCN" }, "detail": { "zh": "MONOPRIL 10/20/40 mg 的 FDA 历史 RLD 条目均列为 DISCN，且不是因安全性或有效性撤市；不代表实时供应。", "en": "FDA historical RLD entries for MONOPRIL 10/20/40 mg are all DISCN and not withdrawn for safety or effectiveness; this is not live-supply evidence." } }, { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "当前公开仿制药标签", "en": "Current public generic label" }, "detail": { "zh": "公开说明书为 Chartwell RX 福辛普利钠片；必须按实际包装、NDC 与标签版本确认。", "en": "The public leaflet is for Chartwell RX fosinopril sodium tablets and must be checked against the actual pack, NDC and label version." } }, { "market": { "zh": "美国以外市场", "en": "Markets outside the United States" }, "status": { "zh": "当地商品名、批准、包装和供应未由本档案确认", "en": "Local brand, approval, pack and supply are not established by this dossier" }, "detail": { "zh": "不从美国历史 RLD 或仿制药标签外推其他市场状态。", "en": "No other-market status is inferred from the U.S. historical RLD or generic label." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "MONOPRIL 与 MONOPRIL-HCT 是一回事吗？", "en": "Are MONOPRIL and MONOPRIL-HCT the same product?" }, "answer": { "zh": "不是。MONOPRIL 是福辛普利钠单方；MONOPRIL-HCT 另含氢氯噻嗪。共同名称不能作为自行叠加、替换或换算依据。", "en": "No. MONOPRIL is fosinopril sodium alone, whereas MONOPRIL-HCT also contains hydrochlorothiazide. A shared name is not a basis for self-combination, substitution or conversion." } }, { "question": { "zh": "历史 10/20/40 mg 是否等于我该吃几片？", "en": "Do historical 10/20/40 mg strengths tell me how many tablets to take?" }, "answer": { "zh": "不等于。它们只是历史产品的每片规格。个人片数、频次、肾功能、合并用药和是否需要调整必须由开方团队依据实际药盒、处方、检查结果和完整药单决定。", "en": "No. They are only per-tablet strengths for historical products. Individual tablet counts, frequency, kidney function, co-medications and any adjustment must be decided by the prescribing team using the actual pack, prescription, test results and complete medicine list." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "same-class-is-not-same-medicine", "interactions-are-not-a-home-scheduling-problem", "dosage-forms-are-part-of-medicine-identity" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/monopril-fosinopril/", "en": "https://origindrug.com/en/drugs/monopril-fosinopril/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "elavil-amitriptyline", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-09-13", "status": "published_traceable_archive" }, "names": { "brand": "ELAVIL", "generic": "阿米替林盐酸盐普通口服片", "aliases": [ "Elavil", "amitriptyline", "amitriptyline hydrochloride", "amitriptyline hydrochloride tablets", "阿米替林", "盐酸阿米替林", "盐酸阿米替林片", "ELAVIL", "NDA 012703", "ELAVIL 10 mg", "ELAVIL 25 mg", "ELAVIL 50 mg", "ELAVIL 75 mg", "ELAVIL 100 mg", "ELAVIL 150 mg" ], "marketBrandNames": [ { "name": "ELAVIL", "market": { "zh": "美国", "en": "United States" }, "evidenceStatus": "historical_regulatory_record", "note": { "zh": "NDA 012703：10/25/50/75/100/150 mg 历史单方口服片均为 RLD，当前均为 DISCN；监管历史不等于实时供应。", "en": "NDA 012703: historical 10/25/50/75/100/150 mg single-ingredient oral tablets are RLD entries and currently DISCN; regulatory history is not live-supply evidence." }, "source": { "id": "src_10e511bf83430e3b", "label": "FDA Orange Book 数据文件：ELAVIL（阿米替林盐酸盐）NDA 012703 的 10/25/50/75/100/150 mg 历史美国口服片 RLD 条目；均为 DISCN，并记录非因安全性或有效性撤市", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } }, { "name": "AMITRIPTYLINE HYDROCHLORIDE", "market": { "zh": "美国", "en": "United States" }, "evidenceStatus": "dated_regulatory_record", "note": { "zh": "当前可公开阅读的是 Zydus 仿制药标签；不把它改写成 ELAVIL 原品牌包装。", "en": "The current publicly readable source is a Zydus generic label; it is not rewritten as an original ELAVIL pack." }, "source": { "id": "src_1738f8543d1db3f0", "label": "DailyMed（NLM）：阿米替林盐酸盐薄膜衣片当前美国公开仿制药说明书（Zydus Lifesciences；2025-10-04 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?audience=consumer&setid=4159b10e-f589-486c-969d-9b4544b098b5", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-13", "reviewedAt": "2026-09-13" } } ], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "精神健康", "sourceArchiveMarket": "FDA Orange Book 的 ELAVIL NDA 012703 记录对应 10、25、50、75、100、150 mg 历史口服片 RLD 条目，均为 DISCN，且数据记录为非因安全性或有效性撤市。当前公开阅读来源是 Zydus 的仿制药阿米替林盐酸盐薄膜衣片标签；它不是历史 ELAVIL 品牌包装、实时库存或其他市场状态。ELAVIL 的注射剂（NDA 012704）与本页口服片分开，不可混作同一产品。", "dosageFormClass": "阿米替林盐酸盐普通口服片。历史 ELAVIL 口服片、阿米替林注射剂、含氯氮卓的复方及其他三环类抗抑郁药在成分、剂型、规格与风险边界上均不是同一产品，不能只按名称、用途或 mg 自行换算、拼接、叠加或替换。", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "美国历史口服片批准早于 1982 年（FDA Orange Book 记录）", "archiveSponsorText": "AstraZeneca Pharmaceuticals LP（FDA 历史 NDA/RLD 条目申请主体）；Zydus Lifesciences Limited（当前公开仿制药标签主体）" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [ "ELAVIL", "Elavil", "amitriptyline hydrochloride tablets", "盐酸阿米替林片" ], "excludedProductCues": [ "ELAVIL injection", "amitriptyline injection", "chlordiazepoxide and amitriptyline", "氯氮平", "氯氮平与阿米替林复方", "other tricyclic antidepressants" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "status": "withheld_repackaged_or_non_exact_visual", "title": { "zh": "未展示 ELAVIL 外观图：历史原研与当前仿制药标签不能混作同一包装", "en": "ELAVIL image withheld: a historical originator and a current generic label are not one package" }, "summary": { "zh": "本次核验保留了历史 ELAVIL 口服片的 FDA 产品身份及当前阿米替林盐酸盐仿制药公开说明书，但未保留能与历史 ELAVIL、特定规格、特定包装和公开一手来源逐一对应的准确外观图。为避免把仿制药、注射剂、其他市场、历史版本或来源不明图片误作原品牌外观，本页不展示包装图。", "en": "This review retains the historical FDA identity for ELAVIL oral tablets and a current public generic amitriptyline label, but no exact public image was retained that matches historical ELAVIL, one strength, one pack and a primary source one-to-one. To avoid presenting generic, injectable, other-market, historical-version or source-uncertain imagery as the originator appearance, this page shows no package image." }, "source": { "id": "src_10e511bf83430e3b", "label": "FDA Orange Book 数据文件：ELAVIL（阿米替林盐酸盐）NDA 012703 的 10/25/50/75/100/150 mg 历史美国口服片 RLD 条目；均为 DISCN，并记录非因安全性或有效性撤市", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "阿米替林说明书放大阅读：先分清历史品牌、每片 mg、嗜睡跌倒与同类药", "en": "Amitriptyline enlarged-label reading: first separate historical brand, mg per tablet, sedation/falls and related medicines" }, "summary": { "zh": "ELAVIL 历史 10/25/50/75/100/150 mg 是每片阿米替林盐酸盐规格，不是个人片数，也不能与注射剂、复方、其他三环类抗抑郁药、SSRI/SNRI、镇静药或酒精按数字自行互换。当前公开说明书属于仿制药，须与手中药盒的成分、剂型、规格、市场和文件版本逐项核对。", "en": "Historical ELAVIL 10/25/50/75/100/150 mg figures are amitriptyline hydrochloride strengths per tablet. They are not an individual's tablet count and cannot be self-interchanged by numbers with injection, combinations, another tricyclic antidepressant, an SSRI/SNRI, sedatives or alcohol. The current public leaflet is generic and must be checked item by item against the pack in hand for ingredient, form, strength, market and document version." }, "checks": [ { "zh": "当前标签带有关于儿童、青少年和年轻成人自杀想法与行为风险的黑框警示。出现自伤/自杀想法、明显行为变化或紧急安全担忧时，应立即使用当地急救或危机支持；不要等待网页判断，也不要以此自行骤停、加量或换药。", "en": "The current label carries a boxed warning about suicidal thoughts and behaviours in children, adolescents and young adults. With self-harm/suicide thoughts, marked behaviour change or an urgent safety concern, use local emergency or crisis support immediately; do not wait for a website assessment or self-stop, increase or switch." }, { "zh": "嗜睡、头晕、站起时不稳、视物模糊、口干、便秘或排尿困难都应按准确药盒和完整药单核对。老人、痴呆风险者、跌倒史、青光眼或排尿问题者，以及合用酒精、阿片类、苯二氮卓类、抗组胺药或其他镇静药者尤其需要专业复核。", "en": "Drowsiness, dizziness, unsteadiness on standing, blurred vision, dry mouth, constipation or urinary difficulty should be reviewed against the exact pack and complete medicine list. Older adults, people at dementia or fall risk, those with glaucoma or urinary problems, and people using alcohol, opioids, benzodiazepines, antihistamines or another sedative especially need professional review." }, { "zh": "MAOI、其他影响血清素的药、曲马多、利奈唑胺、静脉亚甲蓝、某些心律药，以及影响中枢神经系统或心率节律的产品同处药单时，需要专业人员核对相互作用与心律风险。不要自行叠加、错开、轮换或用剩药替代。", "en": "An MAOI, another serotonergic medicine, tramadol, linezolid, intravenous methylene blue, some rhythm medicines, or a product affecting the central nervous system or cardiac rhythm on the same list requires professional interaction and rhythm-risk review. Do not self-combine, separate, alternate or substitute leftovers." }, { "zh": "昏厥、明显心悸、抽搐、严重意识变化、呼吸困难、面唇舌喉肿胀或无法保持安全时，应立即使用当地急救服务并携带全部药盒；网页不据此决定是否停药、补服或加量。", "en": "Fainting, marked palpitations, seizure, severe altered awareness, breathing difficulty, face/lip/tongue/throat swelling or inability to remain safe requires local emergency services immediately with every medicine pack; the site does not decide interruption, make-up use or an increase." } ], "source": { "id": "src_1738f8543d1db3f0", "label": "DailyMed（NLM）：阿米替林盐酸盐薄膜衣片当前美国公开仿制药说明书（Zydus Lifesciences；2025-10-04 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?audience=consumer&setid=4159b10e-f589-486c-969d-9b4544b098b5", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-13", "reviewedAt": "2026-09-13" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "阿米替林怎样起作用：三环类药物的单胺再摄取与抗胆碱能影响，不等于可自行换药", "en": "How amitriptyline works: tricyclic monoamine-reuptake and anticholinergic effects do not make medicines self-interchangeable" }, "summary": { "zh": "阿米替林属于三环类抗抑郁药；当前标签的药理资料可帮助理解其对单胺再摄取及其他受体作用为何会伴随嗜睡、抗胆碱能和心血管相关线索。机制只能解释药理关系，不能决定任何人适不适合、吃几片、何时使用、能否与另一种精神科或镇痛药同服。", "en": "Amitriptyline is a tricyclic antidepressant. Current-label pharmacology can help explain why its monoamine-reuptake and other receptor effects come with sedation, anticholinergic and cardiovascular cues. Mechanism explains a pharmacologic relationship only; it cannot decide individual suitability, tablet count, timing or co-use with another psychiatric or pain medicine." }, "checks": [ { "zh": "ELAVIL、NORPRAMIN、SINEQUAN、PAMELOR、TRAZODONE、CELEXA、LEXAPRO、ZOLOFT 等不是同一种药；共同涉及情绪、睡眠或疼痛问题不建立 mg 换算、轮换或叠加规则。", "en": "ELAVIL, NORPRAMIN, SINEQUAN, PAMELOR, TRAZODONE, CELEXA, LEXAPRO and ZOLOFT are not the same medicine. A shared relationship to mood, sleep or pain concerns does not establish milligram conversion, alternation or combination." }, { "zh": "“有助睡眠”或“止痛”之类的日常说法不能把产品变成可随意加用的助眠药或止痛药。实际适应症、禁忌、年龄、心脏状况、其他中枢神经系统用药和当地标签必须逐项核对。", "en": "Everyday descriptions such as “helps sleep” or “helps pain” do not turn a product into a freely addable sleep or pain medicine. Actual indication, contraindications, age, cardiac status, other central-nervous-system medicines and the local label must be checked item by item." }, { "zh": "基因筛查不是网页替个人选择阿米替林的默认答案。若负责团队认为药物基因、心电图、电解质、肝肾功能或其他检测会改变个人决策，应由其结合准确药品与完整临床资料解释。", "en": "Genetic screening is not the site's default answer for choosing amitriptyline. If the responsible team believes pharmacogenetics, ECG, electrolytes, kidney/liver function or another test may change an individual decision, that team should explain it using the exact medicine and complete clinical information." } ], "source": { "id": "src_1738f8543d1db3f0", "label": "DailyMed（NLM）：阿米替林盐酸盐薄膜衣片当前美国公开仿制药说明书（Zydus Lifesciences；2025-10-04 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?audience=consumer&setid=4159b10e-f589-486c-969d-9b4544b098b5", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-13", "reviewedAt": "2026-09-13" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "ELAVIL", "generic": "阿米替林盐酸盐普通口服片", "dosageFormClass": "阿米替林盐酸盐普通口服片。历史 ELAVIL 口服片、阿米替林注射剂、含氯氮卓的复方及其他三环类抗抑郁药在成分、剂型、规格与风险边界上均不是同一产品，不能只按名称、用途或 mg 自行换算、拼接、叠加或替换。" }, "labelSource": { "id": "src_1738f8543d1db3f0", "label": "DailyMed（NLM）：阿米替林盐酸盐薄膜衣片当前美国公开仿制药说明书（Zydus Lifesciences；2025-10-04 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?audience=consumer&setid=4159b10e-f589-486c-969d-9b4544b098b5", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-13", "reviewedAt": "2026-09-13" }, "productRoutes": [ { "source": { "id": "src_1738f8543d1db3f0", "label": "DailyMed（NLM）：阿米替林盐酸盐薄膜衣片当前美国公开仿制药说明书（Zydus Lifesciences；2025-10-04 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?audience=consumer&setid=4159b10e-f589-486c-969d-9b4544b098b5", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-13", "reviewedAt": "2026-09-13" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-09-13", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_10e511bf83430e3b", "label": "FDA Orange Book 数据文件：ELAVIL（阿米替林盐酸盐）NDA 012703 的 10/25/50/75/100/150 mg 历史美国口服片 RLD 条目；均为 DISCN，并记录非因安全性或有效性撤市", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-08-29", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-09-13", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "ELAVIL 是阿米替林盐酸盐普通口服片的历史美国原研档案。10、25、50、75、100、150 mg 是历史每片标签规格，不是个人片数、减量表或与其他精神科、镇痛或助眠药的换算比例。阿米替林可出现嗜睡、体位性低血压、抗胆碱能反应和心律相关风险线索；老人、跌倒风险者及多药使用者应优先让药师或开方团队核对完整药单、实际药盒、心脏病史、青光眼/排尿问题、便秘、酒精及其他中枢神经系统作用药。网页不决定个人剂量、频次、停药或换药。", "history": "FDA Orange Book 记录 ELAVIL NDA 012703 的六个单方口服片 RLD 条目均在 1982 年前获批，当前均为 DISCN，并注明未因安全性或有效性撤市。当前公开说明书为仿制药阿米替林盐酸盐片，帮助阅读当前类别与安全边界；本站不把它当作历史 ELAVIL 品牌外观、包装或供应证明。", "sourceDocuments": [ { "id": "src_10e511bf83430e3b", "label": "FDA Orange Book 数据文件：ELAVIL（阿米替林盐酸盐）NDA 012703 的 10/25/50/75/100/150 mg 历史美国口服片 RLD 条目；均为 DISCN，并记录非因安全性或有效性撤市", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, { "id": "src_1738f8543d1db3f0", "label": "DailyMed（NLM）：阿米替林盐酸盐薄膜衣片当前美国公开仿制药说明书（Zydus Lifesciences；2025-10-04 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?audience=consumer&setid=4159b10e-f589-486c-969d-9b4544b098b5", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-13", "reviewedAt": "2026-09-13" } ], "applicationNumber": "NDA 012703（ELAVIL 历史美国单方口服片）；当前公开仿制药标签：DailyMed SETID 4159b10e-f589-486c-969d-9b4544b098b5", "approvalTimeline": [ { "date": "1981-12-31", "title": { "zh": "历史口服片批准时间仅记录为“1982 年前”", "en": "Historical oral-tablet approval is recorded only as “prior to 1982”" }, "detail": { "zh": "FDA Orange Book 的 NDA 012703 口服片条目使用“Approved Prior to Jan 1, 1982”字段。本站不从该字段虚构具体批准日。", "en": "FDA Orange Book oral-tablet entries under NDA 012703 use the field “Approved Prior to Jan 1, 1982.” The site does not invent a specific approval date from that field." }, "source": { "id": "src_10e511bf83430e3b", "label": "FDA Orange Book 数据文件：ELAVIL（阿米替林盐酸盐）NDA 012703 的 10/25/50/75/100/150 mg 历史美国口服片 RLD 条目；均为 DISCN，并记录非因安全性或有效性撤市", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } }, { "date": "2025-10-04", "title": { "zh": "当前公开仿制药说明书更新", "en": "Current public generic label updated" }, "detail": { "zh": "Zydus 阿米替林盐酸盐薄膜衣片说明书用于阅读当前类别与安全边界，不替代历史 ELAVIL 包装资料。", "en": "The Zydus amitriptyline hydrochloride film-coated-tablet label supports reading current class and safety boundaries; it does not replace historical ELAVIL pack evidence." }, "source": { "id": "src_1738f8543d1db3f0", "label": "DailyMed（NLM）：阿米替林盐酸盐薄膜衣片当前美国公开仿制药说明书（Zydus Lifesciences；2025-10-04 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?audience=consumer&setid=4159b10e-f589-486c-969d-9b4544b098b5", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-13", "reviewedAt": "2026-09-13" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "历史 RLD；当前 DISCN", "en": "Historical RLD; currently DISCN" }, "detail": { "zh": "ELAVIL 10/25/50/75/100/150 mg 口服片的 FDA 历史 RLD 条目均列为 DISCN，且记录为非因安全性或有效性撤市；不代表实时供应。", "en": "FDA historical RLD entries for ELAVIL 10/25/50/75/100/150 mg oral tablets are all DISCN and not withdrawn for safety or effectiveness; this is not live-supply evidence." } }, { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "当前公开仿制药标签", "en": "Current public generic label" }, "detail": { "zh": "公开说明书为 Zydus 阿米替林盐酸盐薄膜衣片；必须按实际包装、NDC 与标签版本确认。", "en": "The public leaflet is for Zydus amitriptyline hydrochloride film-coated tablets and must be checked against the actual pack, NDC and label version." } }, { "market": { "zh": "美国以外市场", "en": "Markets outside the United States" }, "status": { "zh": "当地商品名、批准、包装和供应未由本档案确认", "en": "Local brand, approval, pack and supply are not established by this dossier" }, "detail": { "zh": "不从美国历史 RLD 或仿制药标签外推其他市场状态。", "en": "No other-market status is inferred from the U.S. historical RLD or generic label." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "ELAVIL 的 10/25/50/75/100/150 mg 是否等于我该吃几片？", "en": "Do historical ELAVIL 10/25/50/75/100/150 mg strengths tell me how many tablets to take?" }, "answer": { "zh": "不等于。它们只是历史产品的每片规格。个人片数、频次、年龄、心脏风险、合并用药和任何调整必须由开方团队依据实际药盒、处方、检查结果与完整药单决定。", "en": "No. They are only per-tablet strengths for historical products. Individual tablet counts, frequency, age, cardiac risk, co-medications and any adjustment must be decided by the prescribing team using the actual pack, prescription, test results and complete medicine list." } }, { "question": { "zh": "ELAVIL 与阿米替林注射剂或含氯氮卓的复方是一回事吗？", "en": "Are ELAVIL, amitriptyline injection and a chlordiazepoxide combination the same product?" }, "answer": { "zh": "不是。历史 ELAVIL 本页只限单方口服片；注射剂的给药途径不同，复方另含其他活性成分。共同药名不能作为自行替换、叠加或换算依据。", "en": "No. This historical ELAVIL page is limited to single-ingredient oral tablets; injection has a different route and a combination contains another active ingredient. A shared medicine name is not a basis for self-substitution, combination or conversion." } }, { "question": { "zh": "老人服用后出现困倦、混乱、站不稳或跌倒怎么办？", "en": "What if an older adult develops drowsiness, confusion, unsteadiness or a fall?" }, "answer": { "zh": "及时联系当地医疗服务，并带上全部药盒和完整药单。网页不能判断具体原因，也不要自行骤停或补服；若有昏厥、抽搐、严重意识变化、呼吸困难或无法保持安全，应立即使用当地急救服务。", "en": "Contact local medical services promptly and take every medicine pack and the complete list. The site cannot determine the cause, and the medicine should not be abruptly self-stopped or made up. Fainting, seizure, severe altered awareness, breathing difficulty or inability to remain safe requires local emergency services immediately." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "same-class-is-not-same-medicine", "interactions-are-not-a-home-scheduling-problem", "dosage-forms-are-part-of-medicine-identity" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/elavil-amitriptyline/", "en": "https://origindrug.com/en/drugs/elavil-amitriptyline/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "zovirax-acyclovir", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-09-13", "status": "published_traceable_archive" }, "names": { "brand": "ZOVIRAX", "generic": "阿昔洛韦（acyclovir）口服制剂", "aliases": [ "Zovirax", "acyclovir", "阿昔洛韦", "阿昔洛韦片", "阿昔洛韦胶囊", "阿昔洛韦口服混悬液", "ZOVIRAX", "NDA 018828", "NDA 019909", "NDA 020089", "acyclovir 200 mg capsule", "acyclovir 200 mg/5 mL", "acyclovir 400 mg tablet", "acyclovir 800 mg tablet" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "感染", "sourceArchiveMarket": "本页定位美国历史 ZOVIRAX 口服档案：200 mg 胶囊（NDA 018828）、200 mg/5 mL 口服混悬液（NDA 019909）、400 mg 与 800 mg 口服片（NDA 020089）。FDA 的 2008 品牌标签明确提示其未必是最新批准标签；当前公开阅读入口为两份不同的仿制药 DailyMed 标签。它们不证明历史品牌当前供应、其他国家批准、原研关系、包装或个人可替代性。", "dosageFormClass": "阿昔洛韦的口服胶囊、普通口服片与口服混悬液是不同产品身份。200 mg/5 mL 的液体浓度、200 mg 胶囊和 400/800 mg 片剂不能仅按共同通用名或数字自行换算、混用、替代或拼接。", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "1985—1991（FDA 历史口服品牌申请记录）", "archiveSponsorText": "历史 ZOVIRAX 美国口服标签与 FDA 监管档案；当前公开阅读的仿制药标签主体见各 DailyMed 原始页面" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [ "ZOVIRAX", "Zovirax", "acyclovir", "阿昔洛韦" ], "excludedProductCues": [ "ZOVIRAX ointment", "ZOVIRAX cream", "ZOVIRAX injection", "acyclovir topical", "acyclovir injection", "valacyclovir", "VALTREX" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "status": "withheld_repackaged_or_non_exact_visual", "title": { "zh": "未展示 ZOVIRAX 外观图：历史品牌文件与当前仿制药标签不能混作同一包装", "en": "ZOVIRAX image withheld: a historical brand file and current generic labels are not one package" }, "summary": { "zh": "本页保留的是历史 ZOVIRAX 口服产品身份和当前阿昔洛韦仿制药公开标签；没有公开一手图像能与当前 ZOVIRAX、一个准确剂型、一个准确规格和一个准确包装逐一对应。为避免把仿制药、外用药、注射剂、其他市场或历史包装当作用户手中产品，本页不展示药盒或药片外观。", "en": "This page retains historical ZOVIRAX oral-product identity and current public generic acyclovir labels, but no public primary image is retained that matches current ZOVIRAX, one exact form, one exact strength and one exact pack one-to-one. To avoid presenting generic, topical, injectable, other-market or historical imagery as the visitor's product, no pack or tablet visual is displayed." }, "source": { "id": "src_10e511bf83430e3b", "label": "FDA Orange Book 数据文件：ZOVIRAX 口服胶囊 NDA 018828、口服混悬液 NDA 019909、口服片 NDA 020089 的美国历史产品记录查询入口", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "ZOVIRAX／阿昔洛韦说明书放大阅读：先分清每片、每粒和每 5 mL", "en": "ZOVIRAX / acyclovir label reading: first separate per tablet, per capsule and per 5 mL" }, "summary": { "zh": "历史 ZOVIRAX 标签把口服胶囊、片剂和混悬液分别列出；当前公开阅读资料也分别来自胶囊/片剂和混悬液标签。本模块帮助核对准确剂型、标签单位和需要尽快求助的风险线索，不提供个人片数、毫升数、频率或疗程。", "en": "The historical ZOVIRAX label lists capsules, tablets and suspension separately, and current public reading sources are also separate capsule/tablet and suspension labels. This module helps check the exact form, label unit and urgent-risk cues; it provides no individual tablet, capsule, millilitre, frequency or course instruction." }, "checks": [ { "zh": "200 mg 胶囊是每粒标示量；400 mg、800 mg 是每片标示量；200 mg/5 mL 表示每 5 mL 液体中的标示量。它们不是可以相加、按经验换算或直接推出“该吃几颗/几毫升”的个人答案。", "en": "A 200 mg capsule is an amount per capsule; 400 mg and 800 mg are amounts per tablet; 200 mg/5 mL is an amount in each 5 mL of liquid. They are not numbers to add, convert by experience or turn into an individual's capsule, tablet or millilitre answer." }, { "zh": "胶囊、片剂和混悬液即使都写阿昔洛韦，也不能仅凭共同通用名或总 mg 自行替代；液体还必须同时核对浓度、量具、标签与实际处方。吞咽困难、量具不清或实际药盒不同，应先让药师核对。", "en": "Capsules, tablets and suspension cannot be self-substituted from a shared acyclovir name or total milligrams. A liquid also requires checking its concentration, measuring device, label and actual prescription together. Swallowing difficulty, an unclear device or a different pack needs pharmacist review first." }, { "zh": "当前仿制药标签提示肾功能相关风险，且已报告罕见但严重的皮肤不良反应线索。明显尿量变化、异常嗜睡/意识改变、广泛皮疹、口眼黏膜受累、呼吸困难或其他急性严重不适，应及时使用当地医疗支持；不要自行加量、停药或把剩药给家人。", "en": "Current generic labels include kidney-related risk and rare serious skin-reaction cues. Marked urine change, unusual drowsiness or altered awareness, extensive rash, mouth/eye mucosal involvement, breathing difficulty or another acute serious concern needs timely local medical support. Do not self-increase, stop or share leftover medicine." }, { "zh": "ZOVIRAX 口服档案不包含外用软膏、乳膏或注射剂；VALTREX／伐昔洛韦也是不同药物。相近抗病毒用途不表示可以自行轮换、叠加或按毫克换算。", "en": "This oral ZOVIRAX archive excludes topical ointment, cream and injection; VALTREX / valacyclovir is also a different medicine. A related antiviral use does not permit self-rotation, co-use or milligram conversion." } ], "source": { "id": "src_a2201fe987dcf4fd", "label": "FDA：ZOVIRAX（阿昔洛韦）2008 美国口服胶囊、片剂和混悬液处方信息；文件明确标注并非最新批准标签", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/018828s031lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-13", "reviewedAt": "2026-09-13" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "阿昔洛韦怎样起作用：病毒 DNA 聚合酶相关机制不等于任何皮疹都该用药", "en": "How acyclovir works: a viral-DNA-polymerase mechanism does not mean every rash needs medicine" }, "summary": { "zh": "FDA 历史标签将阿昔洛韦描述为针对疱疹病毒的合成核苷类似物。机制帮助理解为什么剂型、准确诊断、肾功能和完整药单重要；它不能从皮疹、疼痛、水疱或他人经验判断个人是否需要、如何使用或用多久。", "en": "The historical FDA label describes acyclovir as a synthetic nucleoside analogue active against herpesviruses. The mechanism explains why form, exact diagnosis, kidney function and the complete medicine list matter; it cannot decide from a rash, pain, blisters or another person's experience whether someone needs it, how to use it or for how long." }, "checks": [ { "zh": "“抗病毒”不是对所有感染、口腔溃疡、皮疹或感冒的通用结论。不要依据症状相似、旅行经历或家中剩药自行开始、延长、叠加或分享阿昔洛韦。", "en": "“Antiviral” is not a universal conclusion for every infection, mouth sore, rash or cold. Do not start, extend, combine or share acyclovir from similar symptoms, travel history or leftover household medicine." }, { "zh": "与伐昔洛韦、其他抗病毒药、免疫抑制剂、止痛药或可能影响肾脏的药物同在药单时，需要用准确产品、肾功能资料和完整用药清单逐项核对；网页不自动安排错开时间或调整剂量。", "en": "If valacyclovir, another antiviral, immunosuppression, pain medicines or medicines that may affect kidneys appear on the list, review the exact products, kidney information and complete list item by item. The site does not set separation times or adjust a dose." }, { "zh": "即使症状名称、病毒名称或他人的处方相似，也不能据此省略诊断、实验室检查或随访。负责团队会根据准确适应症、年龄、免疫状态、肾功能、妊娠相关信息和当地标签决定下一步；网页不替代这项判断。", "en": "Even a similar symptom name, virus name or another person's prescription cannot replace diagnosis, testing or follow-up. The responsible team uses the exact indication, age, immune status, kidney function, pregnancy-related information and local label to decide next steps; the site does not replace that judgment." } ], "source": { "id": "src_a2201fe987dcf4fd", "label": "FDA：ZOVIRAX（阿昔洛韦）2008 美国口服胶囊、片剂和混悬液处方信息；文件明确标注并非最新批准标签", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/018828s031lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-13", "reviewedAt": "2026-09-13" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "ZOVIRAX", "generic": "阿昔洛韦（acyclovir）口服制剂", "dosageFormClass": "阿昔洛韦的口服胶囊、普通口服片与口服混悬液是不同产品身份。200 mg/5 mL 的液体浓度、200 mg 胶囊和 400/800 mg 片剂不能仅按共同通用名或数字自行换算、混用、替代或拼接。" }, "labelSource": { "id": "src_a2201fe987dcf4fd", "label": "FDA：ZOVIRAX（阿昔洛韦）2008 美国口服胶囊、片剂和混悬液处方信息；文件明确标注并非最新批准标签", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/018828s031lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-13", "reviewedAt": "2026-09-13" }, "productRoutes": [ { "source": { "id": "src_a2201fe987dcf4fd", "label": "FDA：ZOVIRAX（阿昔洛韦）2008 美国口服胶囊、片剂和混悬液处方信息；文件明确标注并非最新批准标签", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/018828s031lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-13", "reviewedAt": "2026-09-13" }, "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-09-13", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_10e511bf83430e3b", "label": "FDA Orange Book 数据文件：ZOVIRAX 口服胶囊 NDA 018828、口服混悬液 NDA 019909、口服片 NDA 020089 的美国历史产品记录查询入口", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-08-29", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_7365a4fba3b6bb37", "label": "DailyMed（NLM）：阿昔洛韦 200 mg 胶囊与片剂当前美国公开仿制药标签（EMC Pharma；2024-12 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=ff18ddde-a07d-47b6-86bc-92d0e80ccde1", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-13", "reviewedAt": "2026-09-13" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-09-13", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_fda09da96d5e0fed", "label": "DailyMed（NLM）：阿昔洛韦口服混悬液当前美国公开仿制药标签（2025-01 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=6a9ea291-4ad5-48a8-8c08-5a17c8757549", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-13", "reviewedAt": "2026-09-13" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-09-13", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-09-13", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "ZOVIRAX 是阿昔洛韦的历史美国口服品牌档案。200 mg 胶囊、200 mg/5 mL 口服混悬液、400 mg 和 800 mg 片剂分别属于不同剂型和产品记录。网页先帮助读者辨认“每粒、每片或每 5 mL”这些标签单位，再阅读官方说明书；不把它们变成任何人的片数、毫升数、频率、疗程、补服或换药方案。", "history": "FDA 历史标签覆盖 ZOVIRAX 口服胶囊、片剂与混悬液；外用软膏、乳膏和注射剂属于不同途径，不并入本口服档案。当前 DailyMed 的阿昔洛韦仿制药标签可用于阅读当前产品级警示，但不应被说成仍在售的历史 ZOVIRAX 原品牌包装。", "sourceDocuments": [ { "id": "src_a2201fe987dcf4fd", "label": "FDA：ZOVIRAX（阿昔洛韦）2008 美国口服胶囊、片剂和混悬液处方信息；文件明确标注并非最新批准标签", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/018828s031lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-13", "reviewedAt": "2026-09-13" }, { "id": "src_10e511bf83430e3b", "label": "FDA Orange Book 数据文件：ZOVIRAX 口服胶囊 NDA 018828、口服混悬液 NDA 019909、口服片 NDA 020089 的美国历史产品记录查询入口", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, { "id": "src_7365a4fba3b6bb37", "label": "DailyMed（NLM）：阿昔洛韦 200 mg 胶囊与片剂当前美国公开仿制药标签（EMC Pharma；2024-12 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=ff18ddde-a07d-47b6-86bc-92d0e80ccde1", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-13", "reviewedAt": "2026-09-13" }, { "id": "src_fda09da96d5e0fed", "label": "DailyMed（NLM）：阿昔洛韦口服混悬液当前美国公开仿制药标签（2025-01 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=6a9ea291-4ad5-48a8-8c08-5a17c8757549", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-13", "reviewedAt": "2026-09-13" } ], "applicationNumber": "历史 ZOVIRAX 美国口服申请：NDA 018828（200 mg 胶囊）、NDA 019909（200 mg/5 mL 混悬液）、NDA 020089（400 mg/800 mg 片剂）", "approvalTimeline": [ { "date": "1985-01-25", "title": { "zh": "ZOVIRAX 200 mg 口服胶囊 FDA 历史申请节点", "en": "Historical FDA application node for ZOVIRAX 200 mg oral capsules" }, "detail": { "zh": "FDA 监管资料将 NDA 018828 与 ZOVIRAX 200 mg 口服胶囊相连。日期用于定位历史美国产品记录，不是当前供应、个人开始用药日或处方频率。", "en": "FDA regulatory material links NDA 018828 with ZOVIRAX 200 mg oral capsules. The date locates a historical U.S. record, not current supply, anyone's start date or prescription frequency." }, "source": { "id": "src_10e511bf83430e3b", "label": "FDA Orange Book 数据文件：ZOVIRAX 口服胶囊 NDA 018828、口服混悬液 NDA 019909、口服片 NDA 020089 的美国历史产品记录查询入口", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } }, { "date": "1989-12-22", "title": { "zh": "ZOVIRAX 200 mg/5 mL 口服混悬液 FDA 历史申请节点", "en": "Historical FDA application node for ZOVIRAX 200 mg/5 mL oral suspension" }, "detail": { "zh": "FDA 监管资料将 NDA 019909 与口服混悬液相连；液体浓度不能与胶囊或片剂的数字直接互换。", "en": "FDA regulatory material links NDA 019909 with oral suspension; its liquid concentration cannot be directly exchanged with capsule or tablet numbers." }, "source": { "id": "src_10e511bf83430e3b", "label": "FDA Orange Book 数据文件：ZOVIRAX 口服胶囊 NDA 018828、口服混悬液 NDA 019909、口服片 NDA 020089 的美国历史产品记录查询入口", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } }, { "date": "1991-04-30", "title": { "zh": "ZOVIRAX 400 mg/800 mg 口服片 FDA 历史申请节点", "en": "Historical FDA application node for ZOVIRAX 400 mg/800 mg oral tablets" }, "detail": { "zh": "FDA 监管资料将 NDA 020089 与 400 mg、800 mg 口服片分别相连。两种强度都是产品身份字段，不是个人用量或换算指令。", "en": "FDA regulatory material links NDA 020089 separately with 400 mg and 800 mg oral tablets. Both strengths are product-identity fields, not an individual-use or conversion instruction." }, "source": { "id": "src_10e511bf83430e3b", "label": "FDA Orange Book 数据文件：ZOVIRAX 口服胶囊 NDA 018828、口服混悬液 NDA 019909、口服片 NDA 020089 的美国历史产品记录查询入口", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "历史 ZOVIRAX 口服文件与当前仿制药阅读入口已分开链接", "en": "Historical ZOVIRAX oral file and current generic reading entries linked separately" }, "detail": { "zh": "历史品牌文件与当前仿制药标签分别保留，避免将历史品牌资料说成实时标签或库存。", "en": "The historical brand file and current generic labels are retained separately, avoiding any statement that a historical brand document is a current label or stock record." } }, { "market": { "zh": "中国大陆、日本、欧盟及其他市场", "en": "Mainland China, Japan, EU and other markets" }, "status": { "zh": "待逐项建立现行市场记录", "en": "Current market record not established" }, "detail": { "zh": "不从美国历史品牌、仿制药标签或共同通用名推定当地商品名、批准、包装、供应、原研关系或可替代性。", "en": "No local trade name, approval, pack, supply, originator relationship or interchangeability is inferred from the U.S. historical brand, generic labels or a shared generic name." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "200 mg/5 mL 与 200 mg 胶囊是一回事吗？", "en": "Are 200 mg/5 mL and a 200 mg capsule the same thing?" }, "answer": { "zh": "不是同一个产品身份字段。前者说明每 5 mL 液体中的标示量，后者说明每粒胶囊中的标示量；是否能使用、如何量取或能否替换必须按准确处方和当前标签由药师或开方人员核对。", "en": "They are not the same product-identity field. The first states an amount in each 5 mL of liquid, while the second states an amount in each capsule. Whether either can be used, measured or substituted requires the exact prescription and current label to be reviewed by a pharmacist or prescriber." } }, { "question": { "zh": "ZOVIRAX 与 VALTREX 能按毫克互换吗？", "en": "Can ZOVIRAX and VALTREX be exchanged by milligrams?" }, "answer": { "zh": "不能。它们是不同药物，剂型、标签、代谢和个人情况都可能不同。不要按相近抗病毒用途、共同家庭成员或数字自行换药、叠加或轮换。", "en": "No. They are different medicines and can differ in form, label, metabolism and individual context. Do not self-switch, combine or alternate from a related antiviral use, shared household member or numbers." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "dosage-forms-are-part-of-medicine-identity", "same-class-is-not-same-medicine", "interactions-are-not-a-home-scheduling-problem" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/zovirax-acyclovir/", "en": "https://origindrug.com/en/drugs/zovirax-acyclovir/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "lithobid-lithium-carbonate", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-09-13", "status": "published_traceable_archive" }, "names": { "brand": "LITHOBID", "generic": "碳酸锂（lithium carbonate）300 mg 缓释口服片", "aliases": [ "Lithobid", "lithium carbonate", "lithium carbonate extended release", "碳酸锂", "碳酸锂缓释片", "锂盐", "LITHOBID", "62559-280-01", "LITHOBID 300" ], "marketBrandNames": [ { "name": "LITHOBID", "market": { "zh": "美国", "en": "United States" }, "evidenceStatus": "dated_regulatory_record", "note": { "zh": "NDA 018027 的 300 mg 缓释口服片；当前阅读文件为 2022-10-28 有效的美国公开标签。", "en": "300 mg extended-release oral tablet under NDA 018027; the reading document is the U.S. public label effective 28 Oct 2022." }, "source": { "id": "src_9c5993526462603e", "label": "DailyMed（NLM）：LITHOBID（碳酸锂）300 mg 薄膜衣缓释口服片美国公开标签（ANI Pharmaceuticals；2022-10-28 有效版本）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?audience=consumer&setid=f7f5b69a-c2a1-4586-a189-1475d41387c0", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-13", "reviewedAt": "2026-09-13" } } ], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "精神健康", "sourceArchiveMarket": "本页建立的是美国 LITHOBID NDA 018027 的 300 mg 缓释口服片档案。DailyMed 所审阅标签有效版本为 2022-10-28，并列示 NDC 62559-280-01、100 片/瓶。FDA Orange Book 数据文件把该产品列为 RLD/RS。上述资料不证明今天的库存、购买渠道、真伪，亦不推定中国大陆、欧盟、日本或其他市场的批准、商品名、包装、供应或可替代性。", "dosageFormClass": "碳酸锂薄膜衣缓释口服片。300 mg 是每片标示量；缓释片、普通口服锂盐片、柠檬酸锂口服液、其他市场产品和其他锂盐不是可按名称或 mg 自行换算、叠加、轮换或替代的同一产品。", "dosageFormClassCode": "oral_modified_release", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "美国历史批准早于 1982 年（FDA Orange Book 记录）", "archiveSponsorText": "ANI Pharmaceuticals, Inc.（所审阅美国公开标签主体及 FDA Orange Book 条目申请主体）" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [ "LITHOBID", "Lithobid", "lithium carbonate extended-release tablets", "碳酸锂缓释片" ], "excludedProductCues": [ "lithium citrate oral solution", "lithium citrate syrup", "lithium carbonate immediate release", "Lithonate", "lithium injection", "氯化锂", "other lithium salt" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-lithobid-lithium-carbonate-300mg-ndc-62559-280-01", "marketCode": "US", "labelVersion": { "zh": "美国公开标签有效版本：2022-10-28", "en": "U.S. public-label effective version: 2022-10-28" }, "dosageForm": { "zh": "LITHOBID 碳酸锂 300 mg 薄膜衣缓释口服片", "en": "LITHOBID lithium carbonate 300 mg film-coated extended-release oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 62559-280-01 / NDA 018027", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片碳酸锂 300 mg；不是个人片数、频率或调整方案", "en": "300 mg lithium carbonate per tablet; not an individual's tablet count, schedule or adjustment plan" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "碳酸锂", "en": "lithium carbonate" }, "value": 300, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人服用指令", "en": "labelled amount per tablet; not an individual-use instruction" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-13", "currentLabelDisplayed": false, "ndcDirectoryListed": false, "marketAvailability": "dated_public_label_not_live_supply_confirmation", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": null, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_9c5993526462603e", "label": "DailyMed（NLM）：LITHOBID（碳酸锂）300 mg 薄膜衣缓释口服片美国公开标签（ANI Pharmaceuticals；2022-10-28 有效版本）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?audience=consumer&setid=f7f5b69a-c2a1-4586-a189-1475d41387c0", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-13", "reviewedAt": "2026-09-13" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "status": "withheld_repackaged_or_non_exact_visual", "title": { "zh": "保留准确产品身份，不以相似锂盐药盒或药片代替外观图", "en": "Exact product identity retained; no look-alike lithium-salt pack or tablet image substituted" }, "summary": { "zh": "公开标签可核对 NDC、剂型、每片标示量、100 片/瓶和片剂刻印线索，但本次未保留一张能与该版本、该 NDC 和公开一手来源逐一对应的可展示包装主图。为避免把普通片、柠檬酸锂口服液、其他市场或来源不明图片误当作 LITHOBID，本页不展示药盒或药片外观图。", "en": "The public label supports checking the NDC, dosage form, per-tablet amount, 100-tablet bottle and imprint clues, but no displayable principal pack image was retained one-to-one for this version, NDC and a primary public source. To avoid presenting an immediate-release tablet, lithium citrate liquid, another-market product or source-uncertain image as LITHOBID, this page withholds pack and tablet imagery." }, "source": { "id": "src_9c5993526462603e", "label": "DailyMed（NLM）：LITHOBID（碳酸锂）300 mg 薄膜衣缓释口服片美国公开标签（ANI Pharmaceuticals；2022-10-28 有效版本）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?audience=consumer&setid=f7f5b69a-c2a1-4586-a189-1475d41387c0", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-13", "reviewedAt": "2026-09-13" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "LITHOBID 说明书放大阅读：先分清缓释片、每片 300 mg 与监测边界", "en": "LITHOBID enlarged label: first separate extended release, 300 mg per tablet and monitoring boundaries" }, "summary": { "zh": "这份美国标签对应碳酸锂 300 mg 缓释片；300 mg 是每片标示量，100 片是包装数量，两者都不是个人该吃几片或多久吃一次的答案。锂中毒风险与血锂浓度密切相关；请用准确药盒、处方和完整药单向负责团队核对，而不是按网站、相似药名或旧药自行调整。", "en": "This U.S. label is for a 300 mg extended-release lithium carbonate tablet; 300 mg is the amount per tablet and 100 tablets is the package count. Neither tells an individual how many tablets or when to take them. Lithium-toxicity risk is closely related to serum lithium concentration; use the exact pack, prescription and complete medicine list with the responsible team, not a website, similar name or leftover medicine, for any adjustment." }, "checks": [ { "zh": "缓释片不是普通碳酸锂片，也不是柠檬酸锂口服液。共同成分或“锂”字不能建立按 mg 自行换算、替换、叠加或轮换。", "en": "An extended-release tablet is not an immediate-release lithium carbonate tablet or a lithium citrate oral liquid. A shared ingredient or the word “lithium” does not establish self-conversion, substitution, combination or alternation by milligrams." }, { "zh": "利尿剂、ACEI/ARB、NSAID 止痛药、脱水、腹泻、呕吐、发热、进食饮水明显变化或肾功能变化都可能使专业人员优先复核锂相关风险；网页不生成暂停、补服、错开时间或加减量指令。", "en": "Diuretics, ACE inhibitors/ARBs, NSAID pain medicines, dehydration, diarrhoea, vomiting, fever, marked food/fluid changes or kidney-function changes can make lithium-related risk a priority for professional review; the site generates no pause, catch-up, spacing or dose-change instruction." }, { "zh": "明显手抖或动作不稳、说话含糊、严重嗜睡或混乱、持续呕吐腹泻、昏厥、异常心跳、呼吸困难或无法保持安全，应立即使用当地急救或医疗支持，并带上全部药盒；不要等待网页判断。", "en": "Marked tremor or unsteadiness, slurred speech, severe drowsiness or confusion, persistent vomiting/diarrhoea, fainting, abnormal heartbeat, breathing difficulty or inability to remain safe requires local emergency or medical support immediately with every medicine pack; do not wait for a website assessment." }, { "zh": "药片颜色、刻印、刻痕或“100 片”只能帮助核对准确产品身份。刻痕本身不表示可以自行掰开、减量或改变产品。", "en": "Tablet colour, imprint, a score line or “100 tablets” can only help check exact product identity. A score line itself does not permit self-splitting, reducing or changing the product." } ], "source": { "id": "src_9c5993526462603e", "label": "DailyMed（NLM）：LITHOBID（碳酸锂）300 mg 薄膜衣缓释口服片美国公开标签（ANI Pharmaceuticals；2022-10-28 有效版本）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?audience=consumer&setid=f7f5b69a-c2a1-4586-a189-1475d41387c0", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-13", "reviewedAt": "2026-09-13" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "碳酸锂怎样起作用：机制阅读不能替代血锂、肾功能和完整药单核对", "en": "How lithium carbonate works: mechanism reading does not replace lithium level, kidney function or full-list review" }, "summary": { "zh": "锂的临床作用涉及多条细胞信号路径，但机制解释不能代替血锂监测，也不能仅凭情绪、睡眠、一次化验或“以前吃过”决定继续、停用、换药或与另一种精神科药同服。对普通读者而言，先分清准确剂型和同时使用的药物，比用机制猜个人方案更安全。", "en": "Lithium's clinical effects involve several cellular-signalling pathways, but a mechanism explanation does not replace serum-lithium monitoring and cannot use mood, sleep, one test result or prior use alone to decide continuation, stopping, switching or co-use with another psychiatric medicine. For ordinary readers, first separating the exact dosage form and every co-medication is safer than guessing an individual plan from mechanism." }, "checks": [ { "zh": "“同属情绪稳定剂”不等于同一种药。碳酸锂、丙戊酸盐、拉莫三嗪、抗精神病药和抗抑郁药不能从共同用途、名称或 mg 自行互换、叠加或轮换。", "en": "Being called a mood stabiliser does not make medicines the same. Lithium carbonate, valproate, lamotrigine, antipsychotics and antidepressants cannot be self-converted, combined or alternated from a shared use, name or milligram figure." }, { "zh": "是否需要药物基因检测不是网页的默认结论；锂相关安全通常还涉及血锂、肾功能、甲状腺、钙水平、心脏风险、年龄、妊娠可能性和完整药单等具体临床信息，应由负责团队解释。", "en": "Whether pharmacogenetic testing is needed is not the site's default conclusion. Lithium-related safety can also involve serum lithium, kidney function, thyroid, calcium, cardiac risk, age, pregnancy potential and the complete medicine list; the responsible team should interpret these clinical details." }, { "zh": "机制相近、情绪症状相似或曾经使用过锂盐，都不能代替当前准确产品、监测结果和专业评估；网页不根据这些线索生成继续、停用或换药结论。", "en": "A similar mechanism, similar mood symptoms or prior lithium use cannot replace the current exact product, monitoring results and professional assessment; the site does not generate a continuation, stopping or switching conclusion from these clues." } ], "source": { "id": "src_9c5993526462603e", "label": "DailyMed（NLM）：LITHOBID（碳酸锂）300 mg 薄膜衣缓释口服片美国公开标签（ANI Pharmaceuticals；2022-10-28 有效版本）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?audience=consumer&setid=f7f5b69a-c2a1-4586-a189-1475d41387c0", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-13", "reviewedAt": "2026-09-13" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "LITHOBID", "generic": "碳酸锂（lithium carbonate）300 mg 缓释口服片", "dosageFormClass": "碳酸锂薄膜衣缓释口服片。300 mg 是每片标示量；缓释片、普通口服锂盐片、柠檬酸锂口服液、其他市场产品和其他锂盐不是可按名称或 mg 自行换算、叠加、轮换或替代的同一产品。" }, "labelSource": { "id": "src_9c5993526462603e", "label": "DailyMed（NLM）：LITHOBID（碳酸锂）300 mg 薄膜衣缓释口服片美国公开标签（ANI Pharmaceuticals；2022-10-28 有效版本）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?audience=consumer&setid=f7f5b69a-c2a1-4586-a189-1475d41387c0", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-13", "reviewedAt": "2026-09-13" }, "productRoutes": [ { "source": { "id": "src_9c5993526462603e", "label": "DailyMed（NLM）：LITHOBID（碳酸锂）300 mg 薄膜衣缓释口服片美国公开标签（ANI Pharmaceuticals；2022-10-28 有效版本）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?audience=consumer&setid=f7f5b69a-c2a1-4586-a189-1475d41387c0", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-13", "reviewedAt": "2026-09-13" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-09-13", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_10e511bf83430e3b", "label": "FDA Orange Book 数据文件：LITHOBID（碳酸锂）NDA 018027、300 mg 缓释口服片 RLD/RS 产品条目", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-08-29", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-09-13", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "LITHOBID 是碳酸锂 300 mg 缓释口服片的美国品牌档案。标签将锂中毒与血锂浓度密切相关，并强调开始治疗前应具备及时准确的血锂检测条件。老人、脱水或进食饮水异常者、肾脏或心脏问题者，以及同时使用利尿剂、ACEI/ARB、NSAID 止痛药或其他可能影响锂水平药物者，应优先让药师或开方团队核对完整药单、实际药盒、近期状况和监测安排。网页不决定个人片数、频率、补服、减停或换药。", "history": "FDA Orange Book 中的 LITHOBID NDA 018027 产品条目使用“Approved Prior to Jan 1, 1982”字段，并为 300 mg 缓释口服片列示 RLD/RS。DailyMed 公开标签标示 ANI Pharmaceuticals、2022-10-28 有效版本。本页保留美国产品和文件日期，不把它写成任何其他市场的现行说明书或供应证明。", "sourceDocuments": [ { "id": "src_9c5993526462603e", "label": "DailyMed（NLM）：LITHOBID（碳酸锂）300 mg 薄膜衣缓释口服片美国公开标签（ANI Pharmaceuticals；2022-10-28 有效版本）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?audience=consumer&setid=f7f5b69a-c2a1-4586-a189-1475d41387c0", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-13", "reviewedAt": "2026-09-13" }, { "id": "src_10e511bf83430e3b", "label": "FDA Orange Book 数据文件：LITHOBID（碳酸锂）NDA 018027、300 mg 缓释口服片 RLD/RS 产品条目", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } ], "applicationNumber": "NDA 018027；DailyMed SETID f7f5b69a-c2a1-4586-a189-1475d41387c0", "approvalTimeline": [ { "date": "1981-12-31", "title": { "zh": "历史批准时间仅记录为“1982 年前”", "en": "Historical approval is recorded only as “prior to 1982”" }, "detail": { "zh": "FDA Orange Book 的 NDA 018027 产品条目使用“Approved Prior to Jan 1, 1982”字段；本站不从该字段虚构具体批准日。", "en": "The FDA Orange Book entry under NDA 018027 uses “Approved Prior to Jan 1, 1982”; the site does not invent a specific approval date from that field." }, "source": { "id": "src_10e511bf83430e3b", "label": "FDA Orange Book 数据文件：LITHOBID（碳酸锂）NDA 018027、300 mg 缓释口服片 RLD/RS 产品条目", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } }, { "date": "2022-10-28", "title": { "zh": "美国公开标签有效版本", "en": "U.S. public-label effective version" }, "detail": { "zh": "DailyMed 标签标示 ANI Pharmaceuticals，覆盖 LITHOBID 300 mg 缓释口服片；它是有日期文件，不是实时供应证明。", "en": "The DailyMed label identifies ANI Pharmaceuticals and covers LITHOBID 300 mg extended-release oral tablets; it is a dated document, not live-supply evidence." }, "source": { "id": "src_9c5993526462603e", "label": "DailyMed（NLM）：LITHOBID（碳酸锂）300 mg 薄膜衣缓释口服片美国公开标签（ANI Pharmaceuticals；2022-10-28 有效版本）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?audience=consumer&setid=f7f5b69a-c2a1-4586-a189-1475d41387c0", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-13", "reviewedAt": "2026-09-13" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "有日期公开标签与 Orange Book 产品记录", "en": "Dated public label and Orange Book product record" }, "detail": { "zh": "可用于核对美国品牌、剂型、每片标示量、NDC 和 RLD/RS 产品字段；不确认今天库存、可购买性、真伪或个人适用。", "en": "They support checking the U.S. brand, form, per-tablet amount, NDC and RLD/RS product fields; they do not establish today's stock, purchase availability, authenticity or individual suitability." } }, { "market": { "zh": "美国以外市场", "en": "Markets outside the United States" }, "status": { "zh": "当地品牌、批准、包装与供应待逐项核验", "en": "Local brand, approval, pack and supply require item-by-item verification" }, "detail": { "zh": "不从美国 LITHOBID 标签外推中国大陆、欧盟、日本或其他市场状态。", "en": "No status for Mainland China, the EU, Japan or another market is inferred from the U.S. LITHOBID label." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "300 mg 是我一次该吃几片吗？", "en": "Does 300 mg tell me how many tablets to take at once?" }, "answer": { "zh": "不是。300 mg 是这一个准确产品的每片标示量。个人片数、频次、任何补服或调整都必须由负责团队结合处方、血锂监测、肾功能和完整药单决定。", "en": "No. 300 mg is the labelled amount per tablet for this exact product. Individual tablet count, schedule, any catch-up and any adjustment must be decided by the responsible team using the prescription, serum-lithium monitoring, kidney function and the complete medicine list." } }, { "question": { "zh": "缓释碳酸锂能和普通片或柠檬酸锂口服液按 mg 互换吗？", "en": "Can extended-release lithium carbonate be exchanged with an immediate-release tablet or lithium citrate liquid by milligrams?" }, "answer": { "zh": "不能自行这样做。它们的剂型、释放特征和产品身份不同；请让药师或开方团队核对准确药盒和处方。", "en": "Do not do this yourself. Their dosage forms, release characteristics and product identities differ; have the exact pack and prescription checked by a pharmacist or prescribing team." } }, { "question": { "zh": "老人出现手抖、走路不稳、混乱或持续呕吐腹泻怎么办？", "en": "What if an older adult develops tremor, unsteadiness, confusion or persistent vomiting/diarrhoea?" }, "answer": { "zh": "不要用网页自行决定停药、补服或减量。及时联系当地医疗服务；如有严重意识变化、昏厥、异常心跳、呼吸困难或无法保持安全，应立即使用当地急救服务，并带上全部药盒。", "en": "Do not use a webpage to decide stopping, catch-up or reduction. Contact local medical services promptly; severe altered awareness, fainting, abnormal heartbeat, breathing difficulty or inability to remain safe requires local emergency services immediately with every medicine pack." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "dosage-forms-are-part-of-medicine-identity", "interactions-are-not-a-home-scheduling-problem", "same-class-is-not-same-medicine" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/lithobid-lithium-carbonate/", "en": "https://origindrug.com/en/drugs/lithobid-lithium-carbonate/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "lunesta-eszopiclone", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-09-02", "status": "published_traceable_archive" }, "names": { "brand": "LUNESTA", "generic": "右佐匹克隆薄膜衣片", "aliases": [ "Lunesta", "eszopiclone", "右佐匹克隆", "右佐匹克隆片", "艾司佐匹克隆", "eszopiclone tablets", "LUNESTA", "NDA 021476", "80725-010-30", "80725-011-30", "80725-012-30", "S190", "S191", "S193" ], "marketBrandNames": [ { "name": "LUNESTA", "market": { "zh": "美国", "en": "United States" }, "evidenceStatus": "current_regulatory_record", "note": { "zh": "NDA 021476；当前标签列 1、2、3 mg 三个 30 片瓶装。监管标签不等于实时供应或个人适用。", "en": "NDA 021476; the current label lists three 30-tablet bottles at 1, 2 and 3 mg. A regulatory label is not live supply or individual suitability." }, "source": { "id": "src_662b67a3310fb05f", "label": "DailyMed（NLM）：LUNESTA 右佐匹克隆当前美国品牌标签、Medication Guide 及三个 30 片瓶装面板", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=3821f4b7-a3c8-4920-ba80-18aa96532c09", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" } } ], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "精神健康", "sourceArchiveMarket": "美国 DailyMed 当前 LUNESTA 品牌标签列 1、2、3 mg 三种薄膜衣片，均为 30 片瓶装并归入 NDA 021476。页面记录美国 C-IV 管制药品身份；不把该分类外推为其他市场法律状态、实时库存或个人适用性。", "dosageFormClass": "右佐匹克隆普通薄膜衣口服片。LUNESTA、AMBIEN（唑吡坦）、DAYVIGO（莱博雷生）、BELSOMRA（苏沃雷生）及佐匹克隆不是同一种药，不建立 mg 换算、轮换、叠加或停换规则。", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "2004（美国初始批准年份）", "archiveSponsorText": "Waylis Therapeutics LLC（当前美国品牌标签包装方）" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [ "LUNESTA eszopiclone", "eszopiclone tablets", "右佐匹克隆片" ], "excludedProductCues": [ "zopiclone", "佐匹克隆", "zolpidem", "唑吡坦", "AMBIEN", "DAYVIGO", "BELSOMRA", "suvorexant", "lemborexant" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-lunesta-eszopiclone-1mg-30-tablet-bottle-ndc-8072501030", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国品牌标签（2023-07 修订）", "en": "Current U.S. DailyMed brand label (revised Jul 2023)" }, "dosageForm": { "zh": "LUNESTA 右佐匹克隆薄膜衣口服片", "en": "LUNESTA eszopiclone film-coated oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 80725-010-30", "pouchCode": null, "applicationNumber": "NDA 021476", "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片右佐匹克隆 1 mg；30 片瓶装", "en": "Eszopiclone 1 mg per tablet; 30-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=lun01-0029-03.jpg&setid=3821f4b7-a3c8-4920-ba80-18aa96532c09&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "右佐匹克隆", "en": "eszopiclone" }, "value": 1, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、睡眠时长、加量或补服指令", "en": "labelled amount per tablet; not an individual's tablet count, sleep duration, increase or make-up instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-02", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "current_regulatory_listing_not_live_stock", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 30, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "浅蓝色", "en": "light blue" }, "shape": { "zh": "圆形薄膜衣片；当前标签未列刻痕", "en": "round film-coated tablet; current label does not list a score" }, "imprint": "S190", "scoreStatus": "unscored_no_split_permission_inferred", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_662b67a3310fb05f", "label": "DailyMed（NLM）：LUNESTA 右佐匹克隆当前美国品牌标签、Medication Guide 及三个 30 片瓶装面板", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=3821f4b7-a3c8-4920-ba80-18aa96532c09", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-lunesta-eszopiclone-2mg-30-tablet-bottle-ndc-8072501130", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国品牌标签（2023-07 修订）", "en": "Current U.S. DailyMed brand label (revised Jul 2023)" }, "dosageForm": { "zh": "LUNESTA 右佐匹克隆薄膜衣口服片", "en": "LUNESTA eszopiclone film-coated oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 80725-011-30", "pouchCode": null, "applicationNumber": "NDA 021476", "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片右佐匹克隆 2 mg；30 片瓶装", "en": "Eszopiclone 2 mg per tablet; 30-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=lun01-0029-04.jpg&setid=3821f4b7-a3c8-4920-ba80-18aa96532c09&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "右佐匹克隆", "en": "eszopiclone" }, "value": 2, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、睡眠时长、加量或补服指令", "en": "labelled amount per tablet; not an individual's tablet count, sleep duration, increase or make-up instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-02", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "current_regulatory_listing_not_live_stock", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 30, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "白色", "en": "white" }, "shape": { "zh": "圆形薄膜衣片；当前标签未列刻痕", "en": "round film-coated tablet; current label does not list a score" }, "imprint": "S191", "scoreStatus": "unscored_no_split_permission_inferred", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_662b67a3310fb05f", "label": "DailyMed（NLM）：LUNESTA 右佐匹克隆当前美国品牌标签、Medication Guide 及三个 30 片瓶装面板", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=3821f4b7-a3c8-4920-ba80-18aa96532c09", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-lunesta-eszopiclone-3mg-30-tablet-bottle-ndc-8072501230", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国品牌标签（2023-07 修订）", "en": "Current U.S. DailyMed brand label (revised Jul 2023)" }, "dosageForm": { "zh": "LUNESTA 右佐匹克隆薄膜衣口服片", "en": "LUNESTA eszopiclone film-coated oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 80725-012-30", "pouchCode": null, "applicationNumber": "NDA 021476", "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片右佐匹克隆 3 mg；30 片瓶装", "en": "Eszopiclone 3 mg per tablet; 30-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=lun01-0029-05.jpg&setid=3821f4b7-a3c8-4920-ba80-18aa96532c09&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "右佐匹克隆", "en": "eszopiclone" }, "value": 3, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、睡眠时长、加量或补服指令", "en": "labelled amount per tablet; not an individual's tablet count, sleep duration, increase or make-up instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-02", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "current_regulatory_listing_not_live_stock", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 30, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "深蓝色", "en": "dark blue" }, "shape": { "zh": "圆形薄膜衣片；当前标签未列刻痕", "en": "round film-coated tablet; current label does not list a score" }, "imprint": "S193", "scoreStatus": "unscored_no_split_permission_inferred", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_662b67a3310fb05f", "label": "DailyMed（NLM）：LUNESTA 右佐匹克隆当前美国品牌标签、Medication Guide 及三个 30 片瓶装面板", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=3821f4b7-a3c8-4920-ba80-18aa96532c09", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-lunesta-eszopiclone-1mg-30-tablet-bottle-ndc-8072501030", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=lun01-0029-03.jpg&setid=3821f4b7-a3c8-4920-ba80-18aa96532c09&type=img", "alt": "LUNESTA 右佐匹克隆 1 mg、NDC 80725-010-30、30 片瓶装的 DailyMed 官方标签面板", "archiveMarket": "美国", "labelVersion": "DailyMed 当前美国品牌标签（2023-07 修订）", "presentation": "1 mg：浅蓝色圆片、S190；NDC 80725-010-30，30 片瓶装。另有 2 mg 白色 S191 与 3 mg 深蓝色 S193 准确包装，须按 NDC 分开核对。", "notice": "此图只对应美国 NDC 80725-010-30 的 1 mg、30 片瓶装，不代表其他强度、佐匹克隆、唑吡坦、其他安眠药、其他市场包装或实时库存，也不用于鉴定真伪。", "source": { "id": "src_662b67a3310fb05f", "label": "DailyMed（NLM）：LUNESTA 右佐匹克隆当前美国品牌标签、Medication Guide 及三个 30 片瓶装面板", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=3821f4b7-a3c8-4920-ba80-18aa96532c09", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "LUNESTA 说明书放大阅读：每片 mg、复杂睡眠行为、次日警觉与镇静叠加", "en": "LUNESTA enlarged label: mg per tablet, complex sleep behaviours, next-day alertness and additive sedation" }, "summary": { "zh": "1、2、3 mg 是每片右佐匹克隆含量；30 Tablets 是整瓶片数。标签有复杂睡眠行为黑框警示。网页只把准确药盒和安全问题讲清楚，不根据失眠天数或昨晚睡眠自行生成片数、服用时点、补服、递减或停换方案。", "en": "The 1, 2 and 3 mg figures are eszopiclone per tablet; 30 Tablets is the bottle count. The label has a boxed warning for complex sleep behaviours. The site explains the exact pack and safety questions but generates no tablet count, timing, make-up, taper or switch from nights of insomnia or last night's sleep." }, "checks": [ { "zh": "梦游、睡眠驾驶、做饭、打电话或在未完全清醒时进行其他活动，即使以前没有发生、即使同时没有饮酒，也可能在首次或以后使用时出现并造成严重伤害。出现后不要自行再次尝试，应立即联系开方团队；急性危险使用当地急救。", "en": "Sleep-walking, sleep-driving, preparing food, making calls or another activity while not fully awake can occur on the first or a later use, even without prior history or alcohol, and can cause serious injury. Do not self-rechallenge; contact the prescriber promptly, and use local emergency care for immediate danger." }, { "zh": "次日嗜睡、反应变慢、记忆或协调受影响会增加驾驶、操作设备和跌倒风险；老人、夜间起床者或计划早起驾驶者应特别把完整情况交给开方团队核对。网页不以‘感觉清醒’证明安全。", "en": "Next-day sleepiness and impaired reaction, memory or coordination can affect driving, equipment use and fall risk. Older adults, people who rise at night or plan early driving need review of the full situation. Feeling awake is not proof of safety." }, { "zh": "酒精、阿片类止痛药、苯二氮䓬类抗焦虑药、其他安眠药、镇静抗组胺药或其他中枢抑制药可能叠加镇静、呼吸和协调风险；不要自行错开、轮换或叠加。", "en": "Alcohol, opioids, benzodiazepine anxiolytics, another sleep medicine, a sedating antihistamine or another CNS depressant can add sedation, breathing and coordination risk. Do not self-space, rotate or combine them." }, { "zh": "标签还涉及至少保留足够睡眠时间、重餐后吸收变慢、强 CYP3A4 抑制剂、肝功能、呼吸功能、抑郁/自杀风险、停用反应和口中异味。任何变化应由开方团队结合准确药盒和完整药单判断。", "en": "The label also addresses adequate time for sleep, slower absorption after a heavy meal, strong CYP3A4 inhibitors, liver and respiratory function, depression/suicidality, withdrawal effects and unpleasant taste. The prescriber should assess any change using the exact pack and complete medicine list." } ], "source": { "id": "src_662b67a3310fb05f", "label": "DailyMed（NLM）：LUNESTA 右佐匹克隆当前美国品牌标签、Medication Guide 及三个 30 片瓶装面板", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=3821f4b7-a3c8-4920-ba80-18aa96532c09", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "右佐匹克隆怎样促进入睡：影响 GABA 受体复合体，不等于可以与其他镇静药相加", "en": "How eszopiclone promotes sleep: action at the GABA receptor complex does not permit addition to other sedatives" }, "summary": { "zh": "标签说明精确机制尚不完全明确，其作用被认为与 GABA 受体复合体、靠近或变构偶联于苯二氮䓬受体的结合位点相互作用有关。‘非苯二氮䓬’不表示没有镇静、行为、依赖、撤药或次日影响；机制不能替个人选药。", "en": "The label states that the precise mechanism is unknown; effects are believed to involve interaction with the GABA receptor complex at binding domains close to or allosterically coupled to benzodiazepine receptors. ‘Nonbenzodiazepine’ does not mean no sedation, behavioural, dependence, withdrawal or next-day effect, and mechanism cannot select a medicine for an individual." }, "checks": [ { "zh": "LUNESTA、AMBIEN、佐匹克隆、DAYVIGO、BELSOMRA、苯二氮䓬类和镇静抗组胺药不是同一种药；共同用于睡眠不建立 mg 换算或轮换表。", "en": "LUNESTA, AMBIEN, zopiclone, DAYVIGO, BELSOMRA, benzodiazepines and sedating antihistamines are not one medicine. A shared sleep-related use creates no milligram conversion or rotation table." }, { "zh": "老人一堆药时，应把非处方感冒/过敏药、止痛药、抗焦虑药、抗抑郁药、酒精及保健品一起列出；品牌不同不排除镇静作用叠加。", "en": "For an older adult with many medicines, include OTC cold/allergy products, pain medicines, anxiolytics, antidepressants, alcohol and supplements. Different brands do not exclude additive sedation." }, { "zh": "失眠可能与疼痛、呼吸、抑郁焦虑、昼夜节律、药物或其他疾病有关；网页不能由作用机制判断该加药、换药、停药或做基因筛查。", "en": "Insomnia may relate to pain, breathing, depression/anxiety, circadian rhythm, medicines or another condition. A mechanism cannot tell the site to add, switch, stop a medicine or order genetic screening." } ], "source": { "id": "src_662b67a3310fb05f", "label": "DailyMed（NLM）：LUNESTA 右佐匹克隆当前美国品牌标签、Medication Guide 及三个 30 片瓶装面板", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=3821f4b7-a3c8-4920-ba80-18aa96532c09", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "LUNESTA", "generic": "右佐匹克隆薄膜衣片", "dosageFormClass": "右佐匹克隆普通薄膜衣口服片。LUNESTA、AMBIEN（唑吡坦）、DAYVIGO（莱博雷生）、BELSOMRA（苏沃雷生）及佐匹克隆不是同一种药，不建立 mg 换算、轮换、叠加或停换规则。" }, "labelSource": { "id": "src_662b67a3310fb05f", "label": "DailyMed（NLM）：LUNESTA 右佐匹克隆当前美国品牌标签、Medication Guide 及三个 30 片瓶装面板", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=3821f4b7-a3c8-4920-ba80-18aa96532c09", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, "productRoutes": [ { "source": { "id": "src_662b67a3310fb05f", "label": "DailyMed（NLM）：LUNESTA 右佐匹克隆当前美国品牌标签、Medication Guide 及三个 30 片瓶装面板", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=3821f4b7-a3c8-4920-ba80-18aa96532c09", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-09-02", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-09-02", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "LUNESTA 是右佐匹克隆薄膜衣片品牌档案。1/2/3 mg 是每片含量，30 Tablets 是整瓶片数。老人、多药使用者或次日需驾驶者应优先核对梦游/睡眠驾驶、次日警觉下降、跌倒、酒精、阿片、抗焦虑药、其他安眠镇静药与强 CYP3A4 抑制剂；网页不替个人决定片数、时间、停药、加量或换药。", "history": "FDA 于 2004-12-15 批准 LUNESTA NDA 021476。2019 年补充批准把可能造成严重伤害或死亡的复杂睡眠行为加入黑框警示。当前 DailyMed 标签由 Waylis Therapeutics LLC 包装，公开三个 30 片瓶装面板。", "sourceDocuments": [ { "id": "src_662b67a3310fb05f", "label": "DailyMed（NLM）：LUNESTA 右佐匹克隆当前美国品牌标签、Medication Guide 及三个 30 片瓶装面板", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=3821f4b7-a3c8-4920-ba80-18aa96532c09", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, { "id": "src_816ce49cce92b200", "label": "FDA：LUNESTA NDA 021476/S-038 复杂睡眠行为黑框警示补充批准函（2019）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021476Orig1s038ltr.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_regulatory_document", "documentKind": "regulatory_approval_letter", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, { "id": "src_fba7ddd8fdd479dc", "label": "FDA：LUNESTA NDA 021476 原始批准资料（2004-12-15）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021476_Lunesta_approv.PDF", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_regulatory_document", "documentKind": "regulatory_approval_package", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" } ], "applicationNumber": "NDA 021476", "approvalTimeline": [ { "date": "2004-12-15", "title": { "zh": "LUNESTA 美国原始批准", "en": "Original U.S. approval of LUNESTA" }, "detail": { "zh": "FDA 原始批准资料列 1、2、3 mg 右佐匹克隆片及失眠适应证。", "en": "The FDA original approval package lists 1, 2 and 3 mg eszopiclone tablets for insomnia." }, "source": { "id": "src_fba7ddd8fdd479dc", "label": "FDA：LUNESTA NDA 021476 原始批准资料（2004-12-15）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021476_Lunesta_approv.PDF", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_regulatory_document", "documentKind": "regulatory_approval_package", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" } }, { "date": "2019-08-18", "title": { "zh": "FDA 批准复杂睡眠行为黑框警示", "en": "FDA approved the boxed warning for complex sleep behaviours" }, "detail": { "zh": "NDA 021476/S-038 针对非快速眼动睡眠异态行为更新标签，并记录严重伤害风险。", "en": "NDA 021476/S-038 updated the label for NREM parasomnias and recorded the risk of serious injury." }, "source": { "id": "src_816ce49cce92b200", "label": "FDA：LUNESTA NDA 021476/S-038 复杂睡眠行为黑框警示补充批准函（2019）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021476Orig1s038ltr.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_regulatory_document", "documentKind": "regulatory_approval_letter", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" } }, { "date": "2023-07-15", "title": { "zh": "当前 DailyMed 品牌标签修订", "en": "Current DailyMed brand-label revision" }, "detail": { "zh": "当前说明书、Medication Guide 与三个 Waylis 30 片瓶装面板可公开阅读。", "en": "The current label, Medication Guide and three Waylis 30-tablet bottle panels are publicly readable." }, "source": { "id": "src_662b67a3310fb05f", "label": "DailyMed（NLM）：LUNESTA 右佐匹克隆当前美国品牌标签、Medication Guide 及三个 30 片瓶装面板", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=3821f4b7-a3c8-4920-ba80-18aa96532c09", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "当前公开品牌标签", "en": "Current public brand label" }, "detail": { "zh": "NDA 021476；1、2、3 mg，三个 30 片瓶装；美国 C-IV。", "en": "NDA 021476; 1, 2 and 3 mg in three 30-tablet bottles; U.S. C-IV." } }, { "market": { "zh": "美国以外市场", "en": "Markets outside the United States" }, "status": { "zh": "本档案未确认当地商品名、法律分类、包装或供应", "en": "Local brand, legal classification, pack and supply are not established" }, "detail": { "zh": "右佐匹克隆、艾司佐匹克隆与佐匹克隆等名称须与当地监管记录和手中药盒逐项核对。", "en": "Names such as eszopiclone and zopiclone require item-by-item checking against the local regulator and pack in hand." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "LUNESTA 和佐匹克隆、唑吡坦、DAYVIGO 是一回事吗？", "en": "Are LUNESTA, zopiclone, zolpidem and DAYVIGO the same medicine?" }, "answer": { "zh": "不是。它们成分、产品、机制细节、市场记录和说明书边界不同；不能按商品名、颜色、用途或 mg 自行换算、轮换或叠加。", "en": "No. Their ingredients, products, mechanism details, market records and label boundaries differ. Brand, colour, purpose or milligrams do not permit self-conversion, rotation or combination." } }, { "question": { "zh": "昨晚没睡好，今晚能自行多吃或再加一种安眠药吗？", "en": "Can I take more or add another sleep medicine after a poor night?" }, "answer": { "zh": "网页不能这样决定。加量或叠加可能增加复杂睡眠行为、次日损害、跌倒和呼吸风险；请用准确药盒、处方、睡眠时间、酒精及完整药单让开方团队或药师核对。", "en": "The site cannot make that decision. Increasing or combining can increase complex sleep behaviour, next-day impairment, falls and breathing risk. Have the prescriber or pharmacist review the exact pack, prescription, available sleep time, alcohol and complete medicine list." } }, { "question": { "zh": "药片很小，可以掰半或与其他强度拼吗？", "en": "The tablet is small. Can it be split or assembled with another strength?" }, "answer": { "zh": "不要从外观或总毫克数推断。当前标签未把刻痕或分片写成个人调整许可；改变规格、片数或停用方式前应让开方团队核对准确处方。", "en": "Do not infer from appearance or total milligrams. The current label does not turn a score or splitting into permission for individual adjustment. Review the exact prescription before changing strength, tablet count or stopping." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "dose-unit-literacy", "same-class-is-not-same-medicine", "interactions-are-not-a-home-scheduling-problem" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/lunesta-eszopiclone/", "en": "https://origindrug.com/en/drugs/lunesta-eszopiclone/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "ativan-lorazepam", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-09-04", "status": "published_traceable_archive" }, "names": { "brand": "ATIVAN", "generic": "劳拉西泮片", "aliases": [ "Ativan", "lorazepam", "lorazepam tablets", "劳拉西泮", "劳拉西泮片", "罗拉", "NDA 017794", "ATIVAN", "0187-0063-01", "0187-0064-01", "0187-0065-01", "BPI 63", "BPI 64", "BPI 65" ], "marketBrandNames": [ { "name": "ATIVAN", "market": { "zh": "美国", "en": "United States" }, "evidenceStatus": "current_regulatory_record", "note": { "zh": "NDA 017794；当前标签列 0.5、1、2 mg 三个 100 片瓶装。监管标签不证明实时供应、可购买性或个人适用。", "en": "NDA 017794; the current label lists three 100-tablet bottles at 0.5, 1 and 2 mg. A regulatory label does not prove live supply, purchase availability or individual suitability." }, "source": { "id": "src_297b05c0abe41cbc", "label": "DailyMed（NLM）：ATIVAN 劳拉西泮当前美国品牌标签、Medication Guide 与三种 100 片瓶装面板（标签修订 2025-07）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=89057c93-8155-4040-acec-64e877bd2b4c", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" } } ], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "精神健康", "sourceArchiveMarket": "美国 DailyMed 当前 ATIVAN 品牌标签列出 0.5 mg、1 mg、2 mg 三种口服片及各自 100 片瓶装面板，均属于 NDA 017794，并标示美国 C-IV。公开标签不等于其他国家批准、实时库存、购买资格或个人适用性。", "dosageFormClass": "ATIVAN 劳拉西泮普通口服片。0.5、1、2 mg 是每片标示量；100 Tablets 是整瓶数量。ATIVAN 注射剂、劳拉西泮口服浓缩液、LOREEV XR 缓释胶囊及其他苯二氮䓬类不是本档案的同一产品。", "dosageFormClassCode": "oral_modified_release", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "1977-09-30（FDA 审评资料所列美国初始批准日期）", "archiveSponsorText": "Bausch Health US LLC（当前美国品牌标签包装方）" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [ "ATIVAN lorazepam", "lorazepam tablets", "劳拉西泮片" ], "excludedProductCues": [ "ATIVAN injection", "lorazepam injection", "LORazepam oral concentrate", "LOREEV XR", "diazepam", "VALIUM", "alprazolam", "XANAX", "clonazepam", "KLONOPIN" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-ativan-lorazepam-tablet-0-5mg-100-bottle-ndc-0187006301", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国品牌标签（标签修订 2025-07；SPL v24）", "en": "Current U.S. DailyMed brand label (label revised Jul 2025; SPL v24)" }, "dosageForm": { "zh": "ATIVAN 劳拉西泮普通口服片", "en": "ATIVAN lorazepam immediate-release oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 0187-0063-01", "pouchCode": null, "applicationNumber": "NDA 017794", "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片劳拉西泮 0.5 mg；100 片瓶装", "en": "Lorazepam 0.5 mg per tablet; 100-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=a9d257a4-095d-49ff-9994-fab290d575d3-00.jpg&setid=89057c93-8155-4040-acec-64e877bd2b4c", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "劳拉西泮", "en": "lorazepam" }, "value": 0.5, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、频次、疗程、减量或停药指令", "en": "labelled amount per tablet; not an individual's tablet count, frequency, course, taper or stop instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-04", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "current_regulatory_listing_not_live_stock", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "白色", "en": "white" }, "shape": { "zh": "五边形（盾形）", "en": "five-sided shield shape" }, "imprint": "A / BPI / 63", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_297b05c0abe41cbc", "label": "DailyMed（NLM）：ATIVAN 劳拉西泮当前美国品牌标签、Medication Guide 与三种 100 片瓶装面板（标签修订 2025-07）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=89057c93-8155-4040-acec-64e877bd2b4c", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-ativan-lorazepam-tablet-1mg-100-bottle-ndc-0187006401", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国品牌标签（标签修订 2025-07；SPL v24）", "en": "Current U.S. DailyMed brand label (label revised Jul 2025; SPL v24)" }, "dosageForm": { "zh": "ATIVAN 劳拉西泮普通口服片", "en": "ATIVAN lorazepam immediate-release oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 0187-0064-01", "pouchCode": null, "applicationNumber": "NDA 017794", "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片劳拉西泮 1 mg；100 片瓶装", "en": "Lorazepam 1 mg per tablet; 100-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=image-04.jpg&setid=89057c93-8155-4040-acec-64e877bd2b4c", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "劳拉西泮", "en": "lorazepam" }, "value": 1, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、频次、疗程、减量或停药指令", "en": "labelled amount per tablet; not an individual's tablet count, frequency, course, taper or stop instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-04", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "current_regulatory_listing_not_live_stock", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "白色", "en": "white" }, "shape": { "zh": "五边形（盾形）", "en": "five-sided shield shape" }, "imprint": "A / BPI / 64", "scoreStatus": "scored_identity_clue_not_self_split_permission", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_297b05c0abe41cbc", "label": "DailyMed（NLM）：ATIVAN 劳拉西泮当前美国品牌标签、Medication Guide 与三种 100 片瓶装面板（标签修订 2025-07）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=89057c93-8155-4040-acec-64e877bd2b4c", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-ativan-lorazepam-tablet-2mg-100-bottle-ndc-0187006501", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国品牌标签（标签修订 2025-07；SPL v24）", "en": "Current U.S. DailyMed brand label (label revised Jul 2025; SPL v24)" }, "dosageForm": { "zh": "ATIVAN 劳拉西泮普通口服片", "en": "ATIVAN lorazepam immediate-release oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 0187-0065-01", "pouchCode": null, "applicationNumber": "NDA 017794", "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片劳拉西泮 2 mg；100 片瓶装", "en": "Lorazepam 2 mg per tablet; 100-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=image-03.jpg&setid=89057c93-8155-4040-acec-64e877bd2b4c", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "劳拉西泮", "en": "lorazepam" }, "value": 2, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、频次、疗程、减量或停药指令", "en": "labelled amount per tablet; not an individual's tablet count, frequency, course, taper or stop instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-04", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "current_regulatory_listing_not_live_stock", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "白色", "en": "white" }, "shape": { "zh": "五边形（盾形）", "en": "five-sided shield shape" }, "imprint": "A / 2 / BPI / 65", "scoreStatus": "scored_identity_clue_not_self_split_permission", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_297b05c0abe41cbc", "label": "DailyMed（NLM）：ATIVAN 劳拉西泮当前美国品牌标签、Medication Guide 与三种 100 片瓶装面板（标签修订 2025-07）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=89057c93-8155-4040-acec-64e877bd2b4c", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-ativan-lorazepam-tablet-1mg-100-bottle-ndc-0187006401", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=image-04.jpg&setid=89057c93-8155-4040-acec-64e877bd2b4c", "alt": "ATIVAN 劳拉西泮 1 mg、NDC 0187-0064-01、100 片瓶装的 DailyMed 官方标签面板", "archiveMarket": "美国", "labelVersion": "DailyMed 当前美国品牌标签（标签修订 2025-07；SPL v24）", "presentation": "ATIVAN 劳拉西泮：每片 1 mg，NDC 0187-0064-01，100 片瓶装；白色盾形、有刻痕，A / BPI / 64。", "notice": "此图只对应所引美国 1 mg、NDC 0187-0064-01、100 片瓶装，不代表 0.5 mg、2 mg、其他剂型、其他市场、实时库存或个人适用性，不用于鉴定真伪，也不授权自行掰片、加减量或停药。", "source": { "id": "src_297b05c0abe41cbc", "label": "DailyMed（NLM）：ATIVAN 劳拉西泮当前美国品牌标签、Medication Guide 与三种 100 片瓶装面板（标签修订 2025-07）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=89057c93-8155-4040-acec-64e877bd2b4c", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "ATIVAN 说明书放大阅读：先看每片 mg、镇静叠加、老人跌倒与突然停用", "en": "ATIVAN enlarged label: mg per tablet, additive sedation, older-adult falls and abrupt withdrawal" }, "summary": { "zh": "0.5、1、2 mg 是每片劳拉西泮含量；100 Tablets 是整瓶片数。1 mg 与 2 mg 标签列有刻痕，但刻痕只是产品身份线索，不是自行掰片、减量或停药许可。说明书把阿片类合用、滥用/误用/成瘾、身体依赖与停药反应置于黑框警告。", "en": "The 0.5, 1 and 2 mg figures are lorazepam per tablet; 100 Tablets is the bottle count. The 1 mg and 2 mg labels describe scores, but a score is an identity clue, not permission to self-split, taper or stop. The boxed warning covers opioid co-use, abuse/misuse/addiction, physical dependence and withdrawal reactions." }, "checks": [ { "zh": "与阿片类止痛药合用可导致深度镇静、呼吸抑制、昏迷和死亡。若出现呼吸浅慢、叫不醒、意识明显异常，应立即联系当地急救；不要先在网页上寻找错开时间或自行减量方案。", "en": "Co-use with an opioid can cause profound sedation, respiratory depression, coma and death. Shallow or slow breathing, inability to awaken or marked altered awareness requires local emergency help; do not first seek a web spacing or self-reduction plan." }, { "zh": "酒精、其他苯二氮䓬类、安眠药、镇静抗组胺药、抗精神病药、部分抗抑郁药、抗惊厥药和麻醉药都可能叠加中枢抑制；品牌不同不等于可以轮换或叠加。", "en": "Alcohol, another benzodiazepine, a sleep medicine, sedating antihistamine, antipsychotic, some antidepressants, anticonvulsants and anaesthetics can add CNS depression. Different brands do not permit rotation or combination." }, { "zh": "持续使用可能形成身体依赖；突然停用或快速减量可引发危及生命的停药反应，包括癫痫发作。不要照抄网页或他人的减量表，应由负责治疗的专业人员制定个体化方案并随访。", "en": "Continued use can cause physical dependence; abrupt discontinuation or rapid reduction can trigger life-threatening withdrawal, including seizures. Do not copy a web or another person's taper; the treating professional must individualise and follow it." }, { "zh": "老年人的镇静和站立不稳发生率会增加，也可能出现更强敏感性；一堆药时应同时核对嗜睡、步态、跌倒、记忆、呼吸、肝肾功能和全部非处方药。网页不因年龄直接给出片数。", "en": "Sedation and unsteadiness increase with age and some older people may be more sensitive. With many medicines, review sleepiness, gait, falls, memory, breathing, liver/kidney status and all OTC products together. The site does not derive a tablet count from age." }, { "zh": "说明书列出丙戊酸与丙磺舒可改变劳拉西泮暴露，氯氮平合用可出现明显镇静、低血压、共济失调、谵妄甚至呼吸停止；这类相互作用必须交给医生或药师核对，不能自行错开解决。", "en": "The label states that valproate and probenecid can alter lorazepam exposure and that clozapine co-use can cause marked sedation, hypotension, ataxia, delirium and respiratory arrest. A clinician or pharmacist must review these interactions; self-spacing is not a solution." } ], "source": { "id": "src_297b05c0abe41cbc", "label": "DailyMed（NLM）：ATIVAN 劳拉西泮当前美国品牌标签、Medication Guide 与三种 100 片瓶装面板（标签修订 2025-07）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=89057c93-8155-4040-acec-64e877bd2b4c", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "作用机制阅读：苯二氮䓬类在 GABA 位点的作用不能证明联用安全", "en": "Mechanism reading: benzodiazepine action at GABA sites does not prove safe co-use" }, "summary": { "zh": "当前标签把 ATIVAN 归为苯二氮䓬类中枢抑制药，并在相互作用部分说明苯二氮䓬类作用于 GABA 位点。它解释为什么镇静和呼吸风险会与其他中枢抑制药叠加，但不能据此选择个人剂量、用药时点或替代药。", "en": "The current label identifies ATIVAN as a benzodiazepine CNS depressant and states in its interaction section that benzodiazepines act at GABA sites. This helps explain additive sedation and breathing risk with other CNS depressants, but cannot select an individual's dose, timing or substitute." }, "checks": [ { "zh": "ATIVAN、VALIUM、XANAX、KLONOPIN 与 LOREEV XR 不是同一个产品；共同涉及 GABA 或焦虑/镇静用途，不建立 mg 一比一换算或轮换表。", "en": "ATIVAN, VALIUM, XANAX, KLONOPIN and LOREEV XR are not one product. Shared GABA-related or anxiety/sedation use creates no one-for-one milligram conversion or rotation table." }, { "zh": "阿片类主要在 μ 受体系统作用，苯二氮䓬类在 GABA 位点作用；机制不同仍可共同压低呼吸与警觉，不能据此推断错开几小时就安全。", "en": "Opioids act mainly at mu-receptor systems while benzodiazepines act at GABA sites; different mechanisms can still jointly depress breathing and alertness, so a time gap cannot be inferred to make co-use safe." }, { "zh": "是否需要基因检测、是否改用另一种抗焦虑药或是否能掰片，不由这个机制段落回答；应回到诊断、准确药盒、处方、完整药单与专业评估。", "en": "This mechanism section cannot decide genetic testing, a switch to another anxiolytic or tablet splitting. Those decisions require the diagnosis, exact pack, prescription, full medicine list and professional assessment." } ], "source": { "id": "src_297b05c0abe41cbc", "label": "DailyMed（NLM）：ATIVAN 劳拉西泮当前美国品牌标签、Medication Guide 与三种 100 片瓶装面板（标签修订 2025-07）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=89057c93-8155-4040-acec-64e877bd2b4c", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "ATIVAN", "generic": "劳拉西泮片", "dosageFormClass": "ATIVAN 劳拉西泮普通口服片。0.5、1、2 mg 是每片标示量；100 Tablets 是整瓶数量。ATIVAN 注射剂、劳拉西泮口服浓缩液、LOREEV XR 缓释胶囊及其他苯二氮䓬类不是本档案的同一产品。" }, "labelSource": { "id": "src_297b05c0abe41cbc", "label": "DailyMed（NLM）：ATIVAN 劳拉西泮当前美国品牌标签、Medication Guide 与三种 100 片瓶装面板（标签修订 2025-07）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=89057c93-8155-4040-acec-64e877bd2b4c", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" }, "productRoutes": [ { "source": { "id": "src_297b05c0abe41cbc", "label": "DailyMed（NLM）：ATIVAN 劳拉西泮当前美国品牌标签、Medication Guide 与三种 100 片瓶装面板（标签修订 2025-07）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=89057c93-8155-4040-acec-64e877bd2b4c", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-09-04", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-09-04", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "ATIVAN 是劳拉西泮普通口服片的美国品牌档案。0.5、1、2 mg 是每片含量，不是应该吃几片；100 Tablets 是整瓶片数。老人、多药使用者及同时接触阿片类止痛药、酒精、安眠药或其他镇静药的人，应优先核对呼吸抑制、过度嗜睡、站立不稳、跌倒、依赖与突然停用风险；网页不生成个人片数或减停方案。", "history": "FDA 审评资料记录 ATIVAN 劳拉西泮片于 1977-09-30 获初始批准，NDA 为 017794。FDA 2023 年 S-049 补充批准涉及过量、新生儿停药以及妊娠和哺乳风险标签修订。当前 DailyMed 品牌标签修订于 2025-07，并列出三个 100 片瓶装面板。", "sourceDocuments": [ { "id": "src_297b05c0abe41cbc", "label": "DailyMed（NLM）：ATIVAN 劳拉西泮当前美国品牌标签、Medication Guide 与三种 100 片瓶装面板（标签修订 2025-07）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=89057c93-8155-4040-acec-64e877bd2b4c", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" }, { "id": "src_bebe9d202c1f5c74", "label": "DailyMed（NLM）：ATIVAN 劳拉西泮 FDA 批准患者用药指南", "url": "https://dailymed.nlm.nih.gov/dailymed/medguide.cfm?setid=89057c93-8155-4040-acec-64e877bd2b4c", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "patient_medication_guide", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" }, { "id": "src_47d8cb230b8de84f", "label": "FDA：LORazepam ER（Loreev XR）多学科审评——ATIVAN NDA 017794 作为 listed drug 及 1977-09-30 初始批准记录", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2022/214826Orig1s000MultidisciplineR.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_regulatory_document", "documentKind": "regulatory_review", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" }, { "id": "src_f873cf117285c96d", "label": "FDA：ATIVAN NDA 017794/S-049 安全性标签补充批准函（过量、新生儿停药及妊娠哺乳风险）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/017794Orig1s049ltr.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_regulatory_document", "documentKind": "regulatory_approval_letter", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" } ], "applicationNumber": "NDA 017794", "approvalTimeline": [ { "date": "1977-09-30", "title": { "zh": "ATIVAN 劳拉西泮片美国初始批准", "en": "Initial U.S. approval of ATIVAN lorazepam tablets" }, "detail": { "zh": "FDA 的后续多学科审评把 ATIVAN 片剂作为 listed drug，并记录 NDA 017794 与该初始批准日期。", "en": "A later FDA multidisciplinary review identifies ATIVAN tablets as the listed drug and records NDA 017794 with this initial approval date." }, "source": { "id": "src_47d8cb230b8de84f", "label": "FDA：LORazepam ER（Loreev XR）多学科审评——ATIVAN NDA 017794 作为 listed drug 及 1977-09-30 初始批准记录", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2022/214826Orig1s000MultidisciplineR.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_regulatory_document", "documentKind": "regulatory_review", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" } }, { "date": "2023-01-13", "title": { "zh": "FDA 批准 S-049 安全性标签补充", "en": "FDA approved the S-049 safety-label supplement" }, "detail": { "zh": "补充批准涉及过量、新生儿停药综合征以及妊娠和哺乳相关风险的标签修订。", "en": "The supplement revised labeling for overdose, neonatal withdrawal syndrome and pregnancy/lactation-related risks." }, "source": { "id": "src_f873cf117285c96d", "label": "FDA：ATIVAN NDA 017794/S-049 安全性标签补充批准函（过量、新生儿停药及妊娠哺乳风险）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/017794Orig1s049ltr.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_regulatory_document", "documentKind": "regulatory_approval_letter", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" } }, { "date": "2025-07-09", "title": { "zh": "当前品牌说明书修订日期", "en": "Current brand-label revision date" }, "detail": { "zh": "DailyMed 当前标签与患者用药指南列出三种准确 100 片瓶装、黑框警告和老年人阅读重点。", "en": "The current DailyMed label and Medication Guide list three exact 100-tablet bottles, boxed warnings and older-adult reading priorities." }, "source": { "id": "src_297b05c0abe41cbc", "label": "DailyMed（NLM）：ATIVAN 劳拉西泮当前美国品牌标签、Medication Guide 与三种 100 片瓶装面板（标签修订 2025-07）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=89057c93-8155-4040-acec-64e877bd2b4c", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "当前公开品牌标签", "en": "Current public brand label" }, "detail": { "zh": "NDA 017794；0.5、1、2 mg 三种 100 片瓶装；美国 C-IV。标签状态不等于实时供应或个人适用。", "en": "NDA 017794; 0.5, 1 and 2 mg in three 100-tablet bottles; U.S. C-IV. Label status is not live supply or individual suitability." } }, { "market": { "zh": "中国大陆、欧盟、日本及其他市场", "en": "Mainland China, EU, Japan and other markets" }, "status": { "zh": "当地商品名、批准、参比、管制分类、包装和供应尚未逐市场确认", "en": "Local brand, approval, reference, controlled-drug class, pack and supply are not yet established market by market" }, "detail": { "zh": "不从美国 ATIVAN 商品名、NDA、NDC、C-IV 或包装外观推定其他市场状态。", "en": "No other-market status is inferred from the U.S. ATIVAN name, NDA, NDC, C-IV class or package appearance." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "0.5 mg、1 mg、2 mg 是应该吃几片吗？", "en": "Do 0.5 mg, 1 mg and 2 mg tell me how many tablets to take?" }, "answer": { "zh": "不是。它们是每片标示含量；100 Tablets 是整瓶片数。个人片数、频次、疗程与减停方式必须以实际处方和负责治疗的专业人员为准。", "en": "No. They are labelled amounts per tablet; 100 Tablets is the bottle count. Individual tablet count, frequency, course and taper/stop plan must come from the actual prescription and treating professional." } }, { "question": { "zh": "1 mg 或 2 mg 有刻痕，能自己掰半吗？", "en": "The 1 mg and 2 mg tablets are scored. Can I split one myself?" }, "answer": { "zh": "不能从刻痕直接得出许可。刻痕首先用于核对准确产品外观；是否可以分割以及怎样改变剂量或停药，必须让开方团队结合实际处方确认。", "en": "A score does not itself grant permission. It first helps identify the exact product; the prescriber must confirm whether it may be split and how any dose change or stop is handled." } }, { "question": { "zh": "和止痛药、安眠药或酒错开几个小时就安全吗？", "en": "Is it safe if separated from a pain medicine, sleep medicine or alcohol by a few hours?" }, "answer": { "zh": "网页不能给出这个结论。阿片类和其他中枢抑制药的作用可能持续并叠加；请把完整药单、饮酒情况和使用时间交给医生或药师核对。出现呼吸浅慢、叫不醒等表现应立即急救。", "en": "The site cannot make that conclusion. Opioid and other CNS-depressant effects can persist and add. Give the full list, alcohol use and timing to a clinician or pharmacist. Shallow breathing or inability to awaken requires immediate emergency help." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "dose-unit-literacy", "same-class-is-not-same-medicine", "interactions-are-not-a-home-scheduling-problem" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/ativan-lorazepam/", "en": "https://origindrug.com/en/drugs/ativan-lorazepam/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "vimpat-lacosamide", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-09-04", "status": "published_traceable_archive" }, "names": { "brand": "VIMPAT", "generic": "拉考沙胺片／口服液", "aliases": [ "Vimpat", "lacosamide", "lacosamide tablets", "lacosamide oral solution", "拉考沙胺", "拉考沙胺片", "拉考沙胺口服液", "维派特", "NDA 022253", "NDA 022255", "VIMPAT", "0131-2477-60", "0131-2478-60", "0131-2479-60", "0131-2480-60", "0131-5410-72" ], "marketBrandNames": [ { "name": "VIMPAT", "market": { "zh": "美国", "en": "United States" }, "evidenceStatus": "current_regulatory_record", "note": { "zh": "当前品牌标签；本页只展示口服片和口服液。监管记录不证明实时供应或个人适用。", "en": "Current brand label; this page displays only oral tablets and oral solution. A regulatory record does not prove live supply or individual suitability." }, "source": { "id": "src_f6dac4b63752748a", "label": "DailyMed（NLM）：VIMPAT 拉考沙胺当前美国品牌标签、Medication Guide、四种口服片与口服液准确包装面板（2026-05 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=9e79b42c-38a3-4b2c-a196-a5a1948250e2", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" } } ], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "神经系统", "sourceArchiveMarket": "美国 DailyMed 当前 VIMPAT 品牌标签把薄膜衣口服片、口服液和静脉注射剂列在同一 SPL 中。本档案面向普通读者只展示 50、100、150、200 mg 四种口服片单位剂量纸盒，以及 10 mg/mL、200 mL 口服液准确面板；注射剂明确排除。美国 CV 管制分类、公开标签和 NDC 不等于其他市场法律状态、实时库存、购买资格或个人适用性。", "dosageFormClass": "VIMPAT 拉考沙胺薄膜衣口服片（每片 50、100、150、200 mg）与口服液（10 mg/mL，200 mL/瓶）。片剂必须整片吞服、不得切开；口服液须用合适量具，不能用家用茶匙。注射剂不是本口服档案同一展示产品。", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "2008-10-28（FDA 原始批准函）", "archiveSponsorText": "UCB, Inc.（当前美国品牌标签包装方）" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [ "VIMPAT lacosamide", "VIMPAT tablets", "VIMPAT oral solution", "拉考沙胺片", "拉考沙胺口服液" ], "excludedProductCues": [ "VIMPAT injection", "lacosamide injection", "generic lacosamide", "KEPPRA", "levetiracetam", "LAMICTAL", "lamotrigine", "TEGRETOL", "carbamazepine" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-vimpat-lacosamide-tablet-50mg-60-unit-dose-carton-ndc-0131247760", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国品牌标签（2026-05 修订；SPL v63）", "en": "Current U.S. DailyMed brand label (revised May 2026; SPL v63)" }, "dosageForm": { "zh": "VIMPAT 拉考沙胺薄膜衣口服片", "en": "VIMPAT lacosamide film-coated oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 0131-2477-60", "pouchCode": null, "applicationNumber": "NDA 022253", "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片拉考沙胺 50 mg；60 片单位剂量纸盒（6 板，每板 10 片）", "en": "Lacosamide 50 mg per tablet; 60-tablet unit-dose carton (6 cards of 10)" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=vimpat-05.jpg&setid=9e79b42c-38a3-4b2c-a196-a5a1948250e2", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "拉考沙胺", "en": "lacosamide" }, "value": 50, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、频次、疗程或停药指令", "en": "labelled amount per tablet; not an individual's tablet count, frequency, course or stopping instruction" } } ], "concentration": null, "container": { "typeCode": "unit_dose_carton", "typeLabel": { "zh": "单位剂量纸盒", "en": "unit-dose carton" }, "fill": null, "countPerPackage": 60, "countUnit": { "zh": "片/盒", "en": "tablets per carton" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-04", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "current_regulatory_listing_not_live_stock", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 60, "unit": { "zh": "片/盒", "en": "tablets per carton" } }, "physicalClues": { "color": { "zh": "粉红色", "en": "pink" }, "shape": { "zh": "椭圆形薄膜衣片", "en": "oval film-coated tablet" }, "imprint": "SP / 50", "scoreStatus": "unscored_do_not_cut", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_f6dac4b63752748a", "label": "DailyMed（NLM）：VIMPAT 拉考沙胺当前美国品牌标签、Medication Guide、四种口服片与口服液准确包装面板（2026-05 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=9e79b42c-38a3-4b2c-a196-a5a1948250e2", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-vimpat-lacosamide-tablet-100mg-60-unit-dose-carton-ndc-0131247860", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国品牌标签（2026-05 修订；SPL v63）", "en": "Current U.S. DailyMed brand label (revised May 2026; SPL v63)" }, "dosageForm": { "zh": "VIMPAT 拉考沙胺薄膜衣口服片", "en": "VIMPAT lacosamide film-coated oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 0131-2478-60", "pouchCode": null, "applicationNumber": "NDA 022253", "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片拉考沙胺 100 mg；60 片单位剂量纸盒（6 板，每板 10 片）", "en": "Lacosamide 100 mg per tablet; 60-tablet unit-dose carton (6 cards of 10)" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=vimpat-06.jpg&setid=9e79b42c-38a3-4b2c-a196-a5a1948250e2", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "拉考沙胺", "en": "lacosamide" }, "value": 100, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、频次、疗程或停药指令", "en": "labelled amount per tablet; not an individual's tablet count, frequency, course or stopping instruction" } } ], "concentration": null, "container": { "typeCode": "unit_dose_carton", "typeLabel": { "zh": "单位剂量纸盒", "en": "unit-dose carton" }, "fill": null, "countPerPackage": 60, "countUnit": { "zh": "片/盒", "en": "tablets per carton" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-04", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "current_regulatory_listing_not_live_stock", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 60, "unit": { "zh": "片/盒", "en": "tablets per carton" } }, "physicalClues": { "color": { "zh": "深黄色", "en": "dark yellow" }, "shape": { "zh": "椭圆形薄膜衣片", "en": "oval film-coated tablet" }, "imprint": "SP / 100", "scoreStatus": "unscored_do_not_cut", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_f6dac4b63752748a", "label": "DailyMed（NLM）：VIMPAT 拉考沙胺当前美国品牌标签、Medication Guide、四种口服片与口服液准确包装面板（2026-05 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=9e79b42c-38a3-4b2c-a196-a5a1948250e2", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-vimpat-lacosamide-tablet-150mg-60-unit-dose-carton-ndc-0131247960", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国品牌标签（2026-05 修订；SPL v63）", "en": "Current U.S. DailyMed brand label (revised May 2026; SPL v63)" }, "dosageForm": { "zh": "VIMPAT 拉考沙胺薄膜衣口服片", "en": "VIMPAT lacosamide film-coated oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 0131-2479-60", "pouchCode": null, "applicationNumber": "NDA 022253", "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片拉考沙胺 150 mg；60 片单位剂量纸盒（6 板，每板 10 片）", "en": "Lacosamide 150 mg per tablet; 60-tablet unit-dose carton (6 cards of 10)" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=vimpat-07.jpg&setid=9e79b42c-38a3-4b2c-a196-a5a1948250e2", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "拉考沙胺", "en": "lacosamide" }, "value": 150, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、频次、疗程或停药指令", "en": "labelled amount per tablet; not an individual's tablet count, frequency, course or stopping instruction" } } ], "concentration": null, "container": { "typeCode": "unit_dose_carton", "typeLabel": { "zh": "单位剂量纸盒", "en": "unit-dose carton" }, "fill": null, "countPerPackage": 60, "countUnit": { "zh": "片/盒", "en": "tablets per carton" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-04", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "current_regulatory_listing_not_live_stock", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 60, "unit": { "zh": "片/盒", "en": "tablets per carton" } }, "physicalClues": { "color": { "zh": "鲑红色", "en": "salmon" }, "shape": { "zh": "椭圆形薄膜衣片", "en": "oval film-coated tablet" }, "imprint": "SP / 150", "scoreStatus": "unscored_do_not_cut", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_f6dac4b63752748a", "label": "DailyMed（NLM）：VIMPAT 拉考沙胺当前美国品牌标签、Medication Guide、四种口服片与口服液准确包装面板（2026-05 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=9e79b42c-38a3-4b2c-a196-a5a1948250e2", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-vimpat-lacosamide-tablet-200mg-60-unit-dose-carton-ndc-0131248060", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国品牌标签（2026-05 修订；SPL v63）", "en": "Current U.S. DailyMed brand label (revised May 2026; SPL v63)" }, "dosageForm": { "zh": "VIMPAT 拉考沙胺薄膜衣口服片", "en": "VIMPAT lacosamide film-coated oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 0131-2480-60", "pouchCode": null, "applicationNumber": "NDA 022253", "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片拉考沙胺 200 mg；60 片单位剂量纸盒（6 板，每板 10 片）", "en": "Lacosamide 200 mg per tablet; 60-tablet unit-dose carton (6 cards of 10)" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=vimpat-08.jpg&setid=9e79b42c-38a3-4b2c-a196-a5a1948250e2", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "拉考沙胺", "en": "lacosamide" }, "value": 200, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、频次、疗程或停药指令", "en": "labelled amount per tablet; not an individual's tablet count, frequency, course or stopping instruction" } } ], "concentration": null, "container": { "typeCode": "unit_dose_carton", "typeLabel": { "zh": "单位剂量纸盒", "en": "unit-dose carton" }, "fill": null, "countPerPackage": 60, "countUnit": { "zh": "片/盒", "en": "tablets per carton" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-04", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "current_regulatory_listing_not_live_stock", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 60, "unit": { "zh": "片/盒", "en": "tablets per carton" } }, "physicalClues": { "color": { "zh": "蓝色", "en": "blue" }, "shape": { "zh": "椭圆形薄膜衣片", "en": "oval film-coated tablet" }, "imprint": "SP / 200", "scoreStatus": "unscored_do_not_cut", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_f6dac4b63752748a", "label": "DailyMed（NLM）：VIMPAT 拉考沙胺当前美国品牌标签、Medication Guide、四种口服片与口服液准确包装面板（2026-05 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=9e79b42c-38a3-4b2c-a196-a5a1948250e2", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-vimpat-lacosamide-oral-solution-10mg-per-ml-200ml-glass-bottle-ndc-0131541072", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国品牌标签（2026-05 修订；SPL v63）", "en": "Current U.S. DailyMed brand label (revised May 2026; SPL v63)" }, "dosageForm": { "zh": "VIMPAT 拉考沙胺口服液", "en": "VIMPAT lacosamide oral solution" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 0131-5410-72", "pouchCode": null, "applicationNumber": "NDA 022255", "presentationRole": null, "primaryStrengthBasisCode": "per_mL", "primaryDisplay": { "zh": "每 1 mL 含拉考沙胺 10 mg；200 mL 玻璃瓶", "en": "Lacosamide 10 mg per mL; 200 mL glass bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=vimpat-10.jpg&setid=9e79b42c-38a3-4b2c-a196-a5a1948250e2", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "拉考沙胺", "en": "lacosamide" }, "value": 10, "unit": "mg/mL", "basisCode": "per_mL", "basisLabel": { "zh": "每毫升标签标示浓度；不是个人应量取的毫升数", "en": "labelled concentration per mL; not the number of mL an individual should measure" } } ], "concentration": null, "container": { "typeCode": "glass_bottle", "typeLabel": { "zh": "玻璃瓶", "en": "glass bottle" }, "fill": null, "countPerPackage": 1, "countUnit": { "zh": "瓶/盒", "en": "bottle per carton" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-04", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "current_regulatory_listing_not_live_stock", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "unit": { "zh": "mL/瓶", "en": "mL per bottle" } }, "physicalClues": { "color": { "zh": "无色至黄色或黄棕色液体", "en": "colourless to yellow or yellow-brown liquid" }, "shape": { "zh": "草莓味口服液；玻璃瓶", "en": "strawberry-flavoured oral solution in a glass bottle" }, "imprint": "NDC 0131-5410-72", "scoreStatus": "not_applicable", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_f6dac4b63752748a", "label": "DailyMed（NLM）：VIMPAT 拉考沙胺当前美国品牌标签、Medication Guide、四种口服片与口服液准确包装面板（2026-05 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=9e79b42c-38a3-4b2c-a196-a5a1948250e2", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-vimpat-lacosamide-tablet-100mg-60-unit-dose-carton-ndc-0131247860", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=vimpat-06.jpg&setid=9e79b42c-38a3-4b2c-a196-a5a1948250e2", "alt": "VIMPAT 拉考沙胺 100 mg、NDC 0131-2478-60、60 片单位剂量纸盒的 DailyMed 官方标签面板", "archiveMarket": "美国", "labelVersion": "DailyMed 当前美国品牌标签（2026-05 修订；SPL v63）", "presentation": "VIMPAT 拉考沙胺：每片 100 mg，NDC 0131-2478-60，60 片单位剂量纸盒（6 板，每板 10 片）；深黄色椭圆片，SP / 100。", "notice": "此图只对应所引美国 100 mg 单位剂量纸盒，不代表其他规格、60 片瓶装、14 片起始包装、口服液、注射剂、其他市场或实时库存，不用于鉴定真伪，也不授权切片、加减量、换药或停药。", "source": { "id": "src_f6dac4b63752748a", "label": "DailyMed（NLM）：VIMPAT 拉考沙胺当前美国品牌标签、Medication Guide、四种口服片与口服液准确包装面板（2026-05 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=9e79b42c-38a3-4b2c-a196-a5a1948250e2", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "VIMPAT 说明书放大阅读：分清每片 mg、每毫升浓度、跌倒、心脏传导与停药风险", "en": "VIMPAT enlarged label: mg per tablet, concentration per mL, falls, cardiac conduction and withdrawal" }, "summary": { "zh": "口服片的 50、100、150、200 mg 是每片含量，60 Tablets（60 片）是整盒片数；口服液 10 mg/mL 是每毫升浓度，200 mL 是整瓶体积。这些包装数字都不是个人用量。患者指南要求片剂整片吞服、不得切开；口服液使用药用滴管或量杯，不能使用家用茶匙。", "en": "For tablets, 50, 100, 150 and 200 mg are amounts per tablet and 60 Tablets is the carton count. For oral solution, 10 mg/mL is the concentration per mL and 200 mL is the bottle volume. None is an individual amount. The Medication Guide says to swallow tablets whole without cutting and to use a medicine dropper or cup, not a household teaspoon, for the solution." }, "checks": [ { "zh": "眩晕、复视、嗜睡、协调和平衡问题会增加跌倒风险；老人或同时使用其他镇静/抗癫痫药时，应把真实药盒、步态变化、跌倒史和完整药单一起交给医生或药师核对。", "en": "Dizziness, double vision, somnolence, coordination and balance problems can increase fall risk. Older adults or people using another sedating or antiseizure medicine should have the real packs, gait changes, fall history and full medicine list reviewed together." }, { "zh": "VIMPAT 可影响 PR 间期并与房室传导阻滞、心动过缓、室性心律失常和晕厥相关。已有心脏病、传导问题，或 β 受体阻滞剂、钙通道阻滞剂、钾通道阻滞剂、钠通道阻滞剂及其他影响传导药物同在药单时，说明书提出心电图和密切监测边界；网页不替代这些检查。", "en": "VIMPAT can affect the PR interval and is associated with AV block, bradycardia, ventricular arrhythmia and syncope. With heart or conduction disease, or beta blockers, calcium-channel blockers, potassium-channel blockers, sodium-channel blockers or other conduction-affecting medicines, the label sets ECG and monitoring boundaries that the site cannot replace." }, { "zh": "不要突然停药或自行快速减量；抗癫痫药突然停用可能增加发作，患者指南警示可能出现持续状态。网页不提供减量表，也不能把 VIMPAT 与 KEPPRA、LAMICTAL、TEGRETOL 等按 mg 一比一换算、轮换或叠加。", "en": "Do not abruptly stop or rapidly self-reduce. Sudden antiseizure-medicine withdrawal can increase seizures, and the Medication Guide warns of status epilepticus. The site provides no taper and cannot convert, rotate or combine VIMPAT one-for-one by milligrams with KEPPRA, LAMICTAL, TEGRETOL or another product." }, { "zh": "情绪、行为或自伤想法突然出现或恶化，应及时联系专业人员；严重皮疹、发热、淋巴结肿大、黄疸、深色尿或多器官过敏线索也需要紧急核对，不能只在网页上观察。", "en": "New or worsening mood, behaviour or self-harm thoughts require prompt professional contact. Serious rash, fever, swollen glands, jaundice, dark urine or multi-organ hypersensitivity clues also require urgent review, not web-only observation." }, { "zh": "口服液按 10 mg/mL 标示，必须用药用量具；不要用家用茶匙，不要凭瓶体积倒取，也不要把毫克数直接当毫升数。个人毫升数只能来自准确处方和专业核对。", "en": "The solution is labelled 10 mg/mL and requires a medicine measuring device. Do not use a household teaspoon, pour by bottle volume or treat milligrams as millilitres. An individual's mL amount must come from the exact prescription and professional review." } ], "source": { "id": "src_f6dac4b63752748a", "label": "DailyMed（NLM）：VIMPAT 拉考沙胺当前美国品牌标签、Medication Guide、四种口服片与口服液准确包装面板（2026-05 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=9e79b42c-38a3-4b2c-a196-a5a1948250e2", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "作用机制阅读：钠通道慢失活线索不能生成换药或联合方案", "en": "Mechanism reading: a slow sodium-channel inactivation clue cannot generate switching or combination plans" }, "summary": { "zh": "当前标签说明 VIMPAT 发挥抗癫痫作用的精确机制尚未完全阐明；体外研究提示拉考沙胺可能选择性增强电压门控钠通道的慢失活，使过度兴奋神经元膜稳定。这个线索不能决定个人剂量、证明与另一种钠通道药同服安全，也不能生成同类药换算表。", "en": "The current label states that the precise mechanism by which VIMPAT exerts antiseizure effects remains incompletely explained. In vitro evidence suggests lacosamide may selectively enhance slow inactivation of voltage-gated sodium channels, stabilising hyperexcitable neuronal membranes. This clue cannot select a dose, prove safe co-use with another sodium-channel medicine or create a class conversion table." }, "checks": [ { "zh": "卡马西平、拉莫三嗪等也可能涉及钠通道，但不同药物的分子、适应症、剂型、药代和相互作用不同；共同机制词不等于可以自行替代或叠加。", "en": "Carbamazepine, lamotrigine and others may also involve sodium channels, but their molecules, indications, forms, pharmacokinetics and interactions differ. A shared mechanism term does not permit self-substitution or combination." }, { "zh": "心脏也依赖离子通道传导，所以神经系统的钠通道机制不能脱离心电图、心脏病史和影响传导药物单独解读。", "en": "The heart also relies on ion-channel conduction, so a neurological sodium-channel mechanism cannot be read apart from ECG, cardiac history and conduction-affecting medicines." }, { "zh": "是否需要基因检测、是否适合老人或能否从另一种抗癫痫药转换，不由机制段落回答；必须回到诊断、准确药盒、处方、肝肾功能、心脏情况与专业评估。", "en": "Mechanism does not decide genetic testing, older-adult suitability or switching from another antiseizure medicine. Those questions require diagnosis, exact packs, prescription, liver/kidney function, cardiac status and professional assessment." } ], "source": { "id": "src_f6dac4b63752748a", "label": "DailyMed（NLM）：VIMPAT 拉考沙胺当前美国品牌标签、Medication Guide、四种口服片与口服液准确包装面板（2026-05 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=9e79b42c-38a3-4b2c-a196-a5a1948250e2", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "VIMPAT", "generic": "拉考沙胺片／口服液", "dosageFormClass": "VIMPAT 拉考沙胺薄膜衣口服片（每片 50、100、150、200 mg）与口服液（10 mg/mL，200 mL/瓶）。片剂必须整片吞服、不得切开；口服液须用合适量具，不能用家用茶匙。注射剂不是本口服档案同一展示产品。" }, "labelSource": { "id": "src_f6dac4b63752748a", "label": "DailyMed（NLM）：VIMPAT 拉考沙胺当前美国品牌标签、Medication Guide、四种口服片与口服液准确包装面板（2026-05 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=9e79b42c-38a3-4b2c-a196-a5a1948250e2", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" }, "productRoutes": [ { "source": { "id": "src_f6dac4b63752748a", "label": "DailyMed（NLM）：VIMPAT 拉考沙胺当前美国品牌标签、Medication Guide、四种口服片与口服液准确包装面板（2026-05 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=9e79b42c-38a3-4b2c-a196-a5a1948250e2", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-09-04", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-09-04", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "VIMPAT 是拉考沙胺口服片和口服液的美国品牌档案。50、100、150、200 mg 是每片含量；10 mg/mL 是口服液每毫升浓度，都不是应该吃几片或量几毫升。老人和多药使用者要优先核对眩晕、复视、步态不稳与跌倒、心脏传导与晕厥、肝肾功能、其他抗癫痫药，以及突然停药导致癫痫加重的风险；网页不生成个人剂量或换停方案。", "history": "FDA 于 2008-10-28 批准 VIMPAT 拉考沙胺片 NDA 022253 与注射剂 NDA 022254。当前 DailyMed SPL v63 于 2026-05 修订，另列口服液 NDA 022255，并保留四种口服片、口服液、患者用药指南、心脏传导和停药风险等阅读内容。", "sourceDocuments": [ { "id": "src_f6dac4b63752748a", "label": "DailyMed（NLM）：VIMPAT 拉考沙胺当前美国品牌标签、Medication Guide、四种口服片与口服液准确包装面板（2026-05 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=9e79b42c-38a3-4b2c-a196-a5a1948250e2", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" }, { "id": "src_bb5da2169ce36a52", "label": "DailyMed（NLM）：VIMPAT 拉考沙胺 FDA 批准患者用药指南", "url": "https://dailymed.nlm.nih.gov/dailymed/medguide.cfm?setid=9e79b42c-38a3-4b2c-a196-a5a1948250e2", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "patient_medication_guide", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" }, { "id": "src_bd801b1c55217038", "label": "FDA：VIMPAT 拉考沙胺片 NDA 022253 与注射剂 NDA 022254 原始批准函（2008-10-28）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022253s000%2C%20022254s000ltr.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_regulatory_document", "documentKind": "regulatory_approval_letter", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" }, { "id": "src_67351f803004edec", "label": "FDA：VIMPAT NDA 022253／022254 原始跨学科总结审评（2008）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022253s000_022254s000_SumR.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_regulatory_document", "documentKind": "regulatory_review", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" } ], "applicationNumber": "NDA 022253 / NDA 022255", "approvalTimeline": [ { "date": "2008-10-28", "title": { "zh": "VIMPAT 拉考沙胺片美国初始批准", "en": "Initial U.S. approval of VIMPAT lacosamide tablets" }, "detail": { "zh": "FDA 原始批准函列出 NDA 022253 的 50、100、150、200 mg 口服片。", "en": "The FDA original approval letter lists 50, 100, 150 and 200 mg oral tablets under NDA 022253." }, "source": { "id": "src_bd801b1c55217038", "label": "FDA：VIMPAT 拉考沙胺片 NDA 022253 与注射剂 NDA 022254 原始批准函（2008-10-28）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022253s000%2C%20022254s000ltr.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_regulatory_document", "documentKind": "regulatory_approval_letter", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" } }, { "date": "2026-05-12", "title": { "zh": "当前品牌说明书生效日期", "en": "Current brand-label effective date" }, "detail": { "zh": "DailyMed SPL v63 汇总口服片、口服液与注射剂，并更新患者指南及安全阅读内容。", "en": "DailyMed SPL v63 covers tablets, oral solution and injection with the current Medication Guide and safety reading." }, "source": { "id": "src_f6dac4b63752748a", "label": "DailyMed（NLM）：VIMPAT 拉考沙胺当前美国品牌标签、Medication Guide、四种口服片与口服液准确包装面板（2026-05 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=9e79b42c-38a3-4b2c-a196-a5a1948250e2", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "当前公开品牌标签", "en": "Current public brand label" }, "detail": { "zh": "本页展示 NDA 022253 四种口服片单位剂量纸盒及 NDA 022255 口服液，均为美国 CV；不代表实时供应。", "en": "This page displays four NDA 022253 unit-dose tablet cartons and the NDA 022255 oral solution, all U.S. Schedule V; not evidence of live supply." } }, { "market": { "zh": "中国大陆、欧盟、日本及其他市场", "en": "Mainland China, EU, Japan and other markets" }, "status": { "zh": "当地商品名、批准、参比、管制分类、包装和供应尚未逐市场确认", "en": "Local brand, approval, reference, controlled-drug class, pack and supply are not yet established market by market" }, "detail": { "zh": "不从美国 VIMPAT 商品名、NDA、NDC、CV 或包装外观推定其他市场状态。", "en": "No other-market status is inferred from the U.S. VIMPAT name, NDA, NDC, Schedule V class or package appearance." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "50、100、150、200 mg 是应该吃几片吗？", "en": "Do 50, 100, 150 and 200 mg tell me how many tablets to take?" }, "answer": { "zh": "不是。这些数字是每片含量；60 Tablets 是单位剂量纸盒中的总片数。个人片数和时间只看准确处方并由负责治疗的专业人员确认。", "en": "No. These are amounts per tablet; 60 Tablets is the carton count. Individual tablet count and timing come only from the exact prescription and treating professional." } }, { "question": { "zh": "片剂能切半吗？", "en": "Can the tablet be cut in half?" }, "answer": { "zh": "当前患者指南明确要求整片吞服、不得切开。不要用数学把较大规格切成较小规格，也不要据此改变剂量。", "en": "The current Medication Guide says to swallow the tablet whole and not cut it. Do not use arithmetic to turn a larger strength into a smaller one or change a dose." } }, { "question": { "zh": "10 mg/mL 等于每次喝 10 mL 吗？", "en": "Does 10 mg/mL mean taking 10 mL each time?" }, "answer": { "zh": "不是。10 mg/mL 表示每 1 mL 的浓度；个人应量取多少毫升必须按处方换算，并用药用量具核对，不能使用家用茶匙。", "en": "No. It is the concentration in each 1 mL. The prescribed number of mL must be calculated from the actual prescription and checked with a medicine measuring device, never a household teaspoon." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "dose-unit-literacy", "same-class-is-not-same-medicine", "interactions-are-not-a-home-scheduling-problem" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/vimpat-lacosamide/", "en": "https://origindrug.com/en/drugs/vimpat-lacosamide/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "topamax-topiramate", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-09-04", "status": "published_traceable_archive" }, "names": { "brand": "TOPAMAX", "generic": "托吡酯片／可撒服胶囊", "aliases": [ "TOPAMAX", "Topamax", "topiramate", "topiramate tablets", "topiramate sprinkle capsules", "托吡酯", "托吡酯片", "托吡酯可撒服胶囊", "妥泰", "NDA 020505", "NDA 020844", "50458-639-65", "50458-640-65", "50458-641-65", "50458-642-65", "50458-645-65", "50458-647-65" ], "marketBrandNames": [ { "name": "TOPAMAX", "market": { "zh": "美国", "en": "United States" }, "evidenceStatus": "current_regulatory_record", "note": { "zh": "当前品牌标签；本页展示普通片与可撒服胶囊。监管记录不证明实时供应或个人适用。", "en": "Current brand label; this page displays conventional tablets and sprinkle capsules. A regulatory record does not prove live supply or individual suitability." }, "source": { "id": "src_e3e6c3d2c730579e", "label": "DailyMed（NLM）：TOPAMAX 托吡酯当前美国品牌标签、Medication Guide、四种口服片与两种可撒服胶囊准确包装面板（2026-03 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=21628112-0c47-11df-95b3-498d55d89593", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" } } ], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "神经系统", "sourceArchiveMarket": "美国 DailyMed 当前 TOPAMAX 品牌标签包含 25、50、100、200 mg 四种包衣口服片和 15、25 mg 两种可撒服胶囊。本档案逐个绑定美国 NDC 与准确包装面板；美国品牌标签、NDA 和 NDC 不等于其他市场法律状态、实时库存、购买资格或个人适用性。", "dosageFormClass": "TOPAMAX 托吡酯包衣口服片（每片 25、50、100、200 mg）与可撒服胶囊（每粒 15、25 mg）。普通片须整片吞服且不能咀嚼；可撒服胶囊可整粒吞服，或把全部内容物撒在一茶匙软食上立即吞下，不能咀嚼，也不能留到以后。", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "1996-12-24（FDA 审评记录）", "archiveSponsorText": "Janssen Pharmaceuticals, Inc.（当前美国品牌标签包装方）" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [ "TOPAMAX topiramate", "TOPAMAX tablets", "TOPAMAX Sprinkle Capsules", "托吡酯片", "托吡酯可撒服胶囊" ], "excludedProductCues": [ "generic topiramate", "TROKENDI XR", "QUDEXY XR", "EPRONTIA", "phentermine/topiramate", "VIMPAT", "DEPAKOTE", "KEPPRA" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-topamax-topiramate-tablet-25mg-60-bottle-ndc-5045863965", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国品牌标签（2026-03 修订；SPL v30）", "en": "Current U.S. DailyMed brand label (revised March 2026; SPL v30)" }, "dosageForm": { "zh": "TOPAMAX 托吡酯包衣口服片", "en": "TOPAMAX topiramate coated oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 50458-639-65", "pouchCode": null, "applicationNumber": "NDA 020505", "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片托吡酯 25 mg；60 片瓶装，含干燥剂", "en": "Topiramate 25 mg per tablet; 60-tablet bottle with desiccant" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=topamax-04.jpg&setid=21628112-0c47-11df-95b3-498d55d89593", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "托吡酯", "en": "topiramate" }, "value": 25, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、频次、疗程、分片或停药指令", "en": "labelled amount per tablet; not an individual's tablet count, frequency, course, splitting or stopping instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "含干燥剂瓶装", "en": "bottle with desiccant" }, "fill": null, "countPerPackage": 60, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-04", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 60, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "乳白色", "en": "cream" }, "shape": { "zh": "圆形包衣片，约 6 mm，无刻痕", "en": "round coated tablet, about 6 mm, unscored" }, "imprint": "OMN / 25", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_e3e6c3d2c730579e", "label": "DailyMed（NLM）：TOPAMAX 托吡酯当前美国品牌标签、Medication Guide、四种口服片与两种可撒服胶囊准确包装面板（2026-03 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=21628112-0c47-11df-95b3-498d55d89593", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-topamax-topiramate-tablet-50mg-60-bottle-ndc-5045864065", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国品牌标签（2026-03 修订；SPL v30）", "en": "Current U.S. DailyMed brand label (revised March 2026; SPL v30)" }, "dosageForm": { "zh": "TOPAMAX 托吡酯包衣口服片", "en": "TOPAMAX topiramate coated oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 50458-640-65", "pouchCode": null, "applicationNumber": "NDA 020505", "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片托吡酯 50 mg；60 片瓶装，含干燥剂", "en": "Topiramate 50 mg per tablet; 60-tablet bottle with desiccant" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=topamax-05.jpg&setid=21628112-0c47-11df-95b3-498d55d89593", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "托吡酯", "en": "topiramate" }, "value": 50, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、频次、疗程、分片或停药指令", "en": "labelled amount per tablet; not an individual's tablet count, frequency, course, splitting or stopping instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "含干燥剂瓶装", "en": "bottle with desiccant" }, "fill": null, "countPerPackage": 60, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-04", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 60, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "浅黄色", "en": "light yellow" }, "shape": { "zh": "圆形包衣片，约 8 mm，无刻痕", "en": "round coated tablet, about 8 mm, unscored" }, "imprint": "OMN / 50", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_e3e6c3d2c730579e", "label": "DailyMed（NLM）：TOPAMAX 托吡酯当前美国品牌标签、Medication Guide、四种口服片与两种可撒服胶囊准确包装面板（2026-03 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=21628112-0c47-11df-95b3-498d55d89593", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-topamax-topiramate-tablet-100mg-60-bottle-ndc-5045864165", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国品牌标签（2026-03 修订；SPL v30）", "en": "Current U.S. DailyMed brand label (revised March 2026; SPL v30)" }, "dosageForm": { "zh": "TOPAMAX 托吡酯包衣口服片", "en": "TOPAMAX topiramate coated oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 50458-641-65", "pouchCode": null, "applicationNumber": "NDA 020505", "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片托吡酯 100 mg；60 片瓶装，含干燥剂", "en": "Topiramate 100 mg per tablet; 60-tablet bottle with desiccant" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=topamax-06.jpg&setid=21628112-0c47-11df-95b3-498d55d89593", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "托吡酯", "en": "topiramate" }, "value": 100, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、频次、疗程、分片或停药指令", "en": "labelled amount per tablet; not an individual's tablet count, frequency, course, splitting or stopping instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "含干燥剂瓶装", "en": "bottle with desiccant" }, "fill": null, "countPerPackage": 60, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-04", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 60, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "黄色", "en": "yellow" }, "shape": { "zh": "圆形包衣片，约 10 mm，无刻痕", "en": "round coated tablet, about 10 mm, unscored" }, "imprint": "OMN / 100", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_e3e6c3d2c730579e", "label": "DailyMed（NLM）：TOPAMAX 托吡酯当前美国品牌标签、Medication Guide、四种口服片与两种可撒服胶囊准确包装面板（2026-03 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=21628112-0c47-11df-95b3-498d55d89593", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-topamax-topiramate-tablet-200mg-60-bottle-ndc-5045864265", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国品牌标签（2026-03 修订；SPL v30）", "en": "Current U.S. DailyMed brand label (revised March 2026; SPL v30)" }, "dosageForm": { "zh": "TOPAMAX 托吡酯包衣口服片", "en": "TOPAMAX topiramate coated oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 50458-642-65", "pouchCode": null, "applicationNumber": "NDA 020505", "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片托吡酯 200 mg；60 片瓶装，含干燥剂", "en": "Topiramate 200 mg per tablet; 60-tablet bottle with desiccant" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=topamax-07.jpg&setid=21628112-0c47-11df-95b3-498d55d89593", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "托吡酯", "en": "topiramate" }, "value": 200, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、频次、疗程、分片或停药指令", "en": "labelled amount per tablet; not an individual's tablet count, frequency, course, splitting or stopping instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "含干燥剂瓶装", "en": "bottle with desiccant" }, "fill": null, "countPerPackage": 60, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-04", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 60, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "鲑红色", "en": "salmon" }, "shape": { "zh": "圆形包衣片，约 10 mm，无刻痕", "en": "round coated tablet, about 10 mm, unscored" }, "imprint": "OMN / 200", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_e3e6c3d2c730579e", "label": "DailyMed（NLM）：TOPAMAX 托吡酯当前美国品牌标签、Medication Guide、四种口服片与两种可撒服胶囊准确包装面板（2026-03 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=21628112-0c47-11df-95b3-498d55d89593", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-topamax-topiramate-sprinkle-capsule-15mg-60-bottle-ndc-5045864765", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国品牌标签（2026-03 修订；SPL v30）", "en": "Current U.S. DailyMed brand label (revised March 2026; SPL v30)" }, "dosageForm": { "zh": "TOPAMAX 托吡酯可撒服胶囊", "en": "TOPAMAX topiramate sprinkle capsule" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 50458-647-65", "pouchCode": null, "applicationNumber": "NDA 020844", "presentationRole": null, "primaryStrengthBasisCode": "per_capsule", "primaryDisplay": { "zh": "每粒托吡酯 15 mg；60 粒瓶装", "en": "Topiramate 15 mg per capsule; 60-capsule bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=topamax-08.jpg&setid=21628112-0c47-11df-95b3-498d55d89593", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "托吡酯", "en": "topiramate" }, "value": 15, "unit": "mg", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒标签标示量；不是个人粒数、频次、疗程或停药指令", "en": "labelled amount per capsule; not an individual's capsule count, frequency, course or stopping instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 60, "countUnit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-04", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 60, "unit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "physicalClues": { "color": { "zh": "白色与透明胶囊，内含白色至类白色小球", "en": "white and clear capsule containing white to off-white spheres" }, "shape": { "zh": "胶囊，约 18 mm，无刻痕", "en": "capsule, about 18 mm, unscored" }, "imprint": "TOP / 15 mg", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_e3e6c3d2c730579e", "label": "DailyMed（NLM）：TOPAMAX 托吡酯当前美国品牌标签、Medication Guide、四种口服片与两种可撒服胶囊准确包装面板（2026-03 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=21628112-0c47-11df-95b3-498d55d89593", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-topamax-topiramate-sprinkle-capsule-25mg-60-bottle-ndc-5045864565", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国品牌标签（2026-03 修订；SPL v30）", "en": "Current U.S. DailyMed brand label (revised March 2026; SPL v30)" }, "dosageForm": { "zh": "TOPAMAX 托吡酯可撒服胶囊", "en": "TOPAMAX topiramate sprinkle capsule" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 50458-645-65", "pouchCode": null, "applicationNumber": "NDA 020844", "presentationRole": null, "primaryStrengthBasisCode": "per_capsule", "primaryDisplay": { "zh": "每粒托吡酯 25 mg；60 粒瓶装", "en": "Topiramate 25 mg per capsule; 60-capsule bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=topamax-09.jpg&setid=21628112-0c47-11df-95b3-498d55d89593", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "托吡酯", "en": "topiramate" }, "value": 25, "unit": "mg", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒标签标示量；不是个人粒数、频次、疗程或停药指令", "en": "labelled amount per capsule; not an individual's capsule count, frequency, course or stopping instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 60, "countUnit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-04", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 60, "unit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "physicalClues": { "color": { "zh": "白色与透明胶囊，内含白色至类白色小球", "en": "white and clear capsule containing white to off-white spheres" }, "shape": { "zh": "胶囊，约 19 mm，无刻痕", "en": "capsule, about 19 mm, unscored" }, "imprint": "TOP / 25 mg", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_e3e6c3d2c730579e", "label": "DailyMed（NLM）：TOPAMAX 托吡酯当前美国品牌标签、Medication Guide、四种口服片与两种可撒服胶囊准确包装面板（2026-03 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=21628112-0c47-11df-95b3-498d55d89593", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-topamax-topiramate-tablet-100mg-60-bottle-ndc-5045864165", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=topamax-06.jpg&setid=21628112-0c47-11df-95b3-498d55d89593", "alt": "TOPAMAX 托吡酯 100 mg、NDC 50458-641-65、60 片瓶装的 DailyMed 官方标签面板", "archiveMarket": "美国", "labelVersion": "DailyMed 当前美国品牌标签（2026-03 修订；SPL v30）", "presentation": "TOPAMAX 托吡酯：每片 100 mg，NDC 50458-641-65，60 片瓶装；黄色圆形无刻痕包衣片，OMN / 100。", "notice": "此图只对应所引美国 100 mg、60 片瓶装面板，不代表其他规格、可撒服胶囊、通用药、缓释制剂、口服液、复方、其他市场或实时库存，不用于鉴定真伪，也不授权分片、加减量、换药或停药。", "source": { "id": "src_e3e6c3d2c730579e", "label": "DailyMed（NLM）：TOPAMAX 托吡酯当前美国品牌标签、Medication Guide、四种口服片与两种可撒服胶囊准确包装面板（2026-03 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=21628112-0c47-11df-95b3-498d55d89593", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "TOPAMAX 说明书放大阅读：分清每片/每粒 mg、普通片与可撒服胶囊、眼部与代谢风险", "en": "TOPAMAX enlarged label: mg per tablet/capsule, conventional versus sprinkle forms, eye and metabolic risks" }, "summary": { "zh": "25、50、100、200 mg 是每片普通片的托吡酯含量；15、25 mg 是每粒可撒服胶囊的含量；60 Tablets/Capsules 是整瓶数量。这些数字都不是个人用量。普通片须整片吞服、不能咀嚼；可撒服胶囊可整粒吞服，也可打开后把全部小球撒在一茶匙软食上立即吞下，不能咀嚼；混合物不能留到以后。", "en": "The 25, 50, 100 and 200 mg figures are topiramate amounts per conventional tablet; 15 and 25 mg are amounts per sprinkle capsule; 60 Tablets/Capsules is the bottle count. None is an individual amount. Tablets are swallowed whole and not chewed. Sprinkle capsules may be swallowed whole or opened so all pellets are placed on one teaspoon of soft food, swallowed immediately, not chewed and not stored." }, "checks": [ { "zh": "新发视力下降、视物异常或眼痛可能提示需要立即处理的眼部问题；说明书警示继发性闭角型青光眼若不治疗可造成永久视力丧失。不要等待网页判断，也不要自行决定停药速度，立即联系医疗专业人员。", "en": "New reduced vision, visual disturbance or eye pain may signal an urgent eye problem. The label warns that untreated secondary angle-closure glaucoma can cause permanent visual loss. Do not wait for a website judgment or choose a stopping speed yourself; seek prompt professional care." }, { "zh": "托吡酯可降低血清碳酸氢盐并引起代谢性酸中毒；肾病、严重呼吸问题、腹泻、酮症饮食或其他导致酸中毒的药物会叠加风险。说明书建议基线和定期测量碳酸氢盐，网页不能代替化验或据此给出加减量。", "en": "Topiramate can lower serum bicarbonate and cause metabolic acidosis. Kidney disease, severe respiratory disorders, diarrhoea, a ketogenic diet or other acidosis-producing medicines can add risk. The label recommends baseline and periodic bicarbonate measurement; the site cannot replace tests or adjust a dose from them." }, { "zh": "思维、注意、记忆、语言、反应速度、嗜睡、眩晕和协调问题会影响驾驶并增加老人跌倒风险；请把实际变化、跌倒史、肾功能、完整药单和准确药盒一起交给医生或药师核对。", "en": "Changes in thinking, attention, memory, speech, reaction speed, sleepiness, dizziness or coordination may affect driving and increase fall risk in older adults. Have the actual changes, fall history, kidney function, complete medicine list and exact pack reviewed together." }, { "zh": "与丙戊酸（如 DEPAKOTE）同用可关联高氨血症/脑病和低体温；与其他碳酸酐酶抑制剂、导致酸中毒的药物或酮症饮食同在时还要核对肾结石风险。不能靠错开时间自行解决，也不能按共同抗癫痫用途或 mg 一比一换药。", "en": "Concomitant valproate (such as DEPAKOTE) is associated with hyperammonaemia/encephalopathy and hypothermia. Other carbonic-anhydrase inhibitors, acidosis-producing medicines or a ketogenic diet also require kidney-stone risk review. Self-separating times does not solve these issues, and a shared antiseizure use or milligram figure does not permit one-for-one switching." }, { "zh": "不要突然停药或自行快速减量；突然停用抗癫痫药可能增加发作，包括持续状态。可撒服胶囊与普通片也不能凭相同 mg 自行互换，个人改变必须由负责治疗的专业人员决定。", "en": "Do not abruptly stop or rapidly self-reduce. Sudden antiseizure-medicine withdrawal can increase seizures, including status epilepticus. Sprinkle capsules and tablets also must not be self-interchanged from matching milligrams; individual changes require the treating professional." }, { "zh": "妊娠或可能怀孕时，胎儿风险与激素避孕效果变化需要尽早专业讨论；严重皮疹、水疱脱皮、面舌喉肿胀、吞咽或呼吸困难属于需要迅速处理的警讯。", "en": "Pregnancy or possible pregnancy requires early professional discussion of fetal risk and possible changes in hormonal-contraceptive effectiveness. Severe rash, blistering or peeling, face/tongue/throat swelling, or trouble swallowing or breathing are warning signs needing prompt care." } ], "source": { "id": "src_e3e6c3d2c730579e", "label": "DailyMed（NLM）：TOPAMAX 托吡酯当前美国品牌标签、Medication Guide、四种口服片与两种可撒服胶囊准确包装面板（2026-03 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=21628112-0c47-11df-95b3-498d55d89593", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "作用机制阅读：四条实验线索不能生成个人选药、换药或联合方案", "en": "Mechanism reading: four experimental clues cannot generate personal selection, switching or combination plans" }, "summary": { "zh": "当前标签说明 TOPAMAX 抗癫痫和预防偏头痛作用的精确机制尚不清楚。临床前研究提示四条可能线索：阻断电压依赖性钠通道、增强部分 GABA-A 受体活动、拮抗 AMPA/海人酸型谷氨酸受体，以及抑制碳酸酐酶 II 与 IV。这些线索不能单独决定个人剂量、证明联合安全或把另一种药按 mg 换算过来。", "en": "The current label states that the precise mechanisms of TOPAMAX for antiseizure and migraine-prevention effects are unknown. Preclinical evidence suggests four possible contributors: blocking voltage-dependent sodium channels, augmenting activity at some GABA-A receptors, antagonising AMPA/kainate glutamate receptors, and inhibiting carbonic anhydrase II and IV. These clues cannot independently select an individual dose, prove combination safety or convert another medicine by milligrams." }, "checks": [ { "zh": "拉莫三嗪、卡马西平、拉考沙胺等也可能涉及钠通道，但分子、剂型、适应症、药代和相互作用不同；共同机制词不等于可以自行替代或叠加。", "en": "Lamotrigine, carbamazepine and lacosamide may also involve sodium channels, but molecules, forms, indications, pharmacokinetics and interactions differ. A shared mechanism term does not permit self-substitution or combination." }, { "zh": "碳酸酐酶抑制线索能帮助理解酸中毒与结石风险，却不能让读者根据喝水量、化验或症状自行改药。", "en": "The carbonic-anhydrase clue helps explain acidosis and stone risk, but it does not let a reader change medicine from fluid intake, tests or symptoms." }, { "zh": "是否适合老人、是否需要基因检测、能否从另一种抗癫痫药转换，都必须回到诊断、实际处方、肾功能、妊娠情况、完整药单与专业评估。", "en": "Older-adult suitability, genetic testing and switching from another antiseizure medicine require diagnosis, the actual prescription, kidney function, pregnancy context, complete medicine list and professional assessment." } ], "source": { "id": "src_e3e6c3d2c730579e", "label": "DailyMed（NLM）：TOPAMAX 托吡酯当前美国品牌标签、Medication Guide、四种口服片与两种可撒服胶囊准确包装面板（2026-03 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=21628112-0c47-11df-95b3-498d55d89593", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "TOPAMAX", "generic": "托吡酯片／可撒服胶囊", "dosageFormClass": "TOPAMAX 托吡酯包衣口服片（每片 25、50、100、200 mg）与可撒服胶囊（每粒 15、25 mg）。普通片须整片吞服且不能咀嚼；可撒服胶囊可整粒吞服，或把全部内容物撒在一茶匙软食上立即吞下，不能咀嚼，也不能留到以后。" }, "labelSource": { "id": "src_e3e6c3d2c730579e", "label": "DailyMed（NLM）：TOPAMAX 托吡酯当前美国品牌标签、Medication Guide、四种口服片与两种可撒服胶囊准确包装面板（2026-03 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=21628112-0c47-11df-95b3-498d55d89593", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" }, "productRoutes": [ { "source": { "id": "src_e3e6c3d2c730579e", "label": "DailyMed（NLM）：TOPAMAX 托吡酯当前美国品牌标签、Medication Guide、四种口服片与两种可撒服胶囊准确包装面板（2026-03 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=21628112-0c47-11df-95b3-498d55d89593", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-09-04", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-09-04", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "TOPAMAX 是托吡酯普通片和可撒服胶囊的美国品牌档案。25、50、100、200 mg 是每片含量，15、25 mg 是每粒含量，60 Tablets/Capsules 是整瓶数量，都不是应该吃几片或几粒。老人和多药使用者要优先核对思维与反应变慢、眩晕和跌倒、新发视力问题或眼痛、碳酸氢盐与代谢性酸中毒、肾结石、丙戊酸等相互作用，以及突然停药导致发作加重的风险；网页不生成个人剂量或换停方案。", "history": "TOPAMAX 托吡酯片 NDA 020505 于 1996-12-24 获批。当前 DailyMed SPL v30 于 2026-03 修订，包含四种口服片、两种可撒服胶囊、患者用药指南、包装面板以及眼部、代谢、认知、妊娠、过敏和停药风险。", "sourceDocuments": [ { "id": "src_e3e6c3d2c730579e", "label": "DailyMed（NLM）：TOPAMAX 托吡酯当前美国品牌标签、Medication Guide、四种口服片与两种可撒服胶囊准确包装面板（2026-03 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=21628112-0c47-11df-95b3-498d55d89593", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" }, { "id": "src_79ee9db25ef88656", "label": "DailyMed（NLM）：TOPAMAX 托吡酯 FDA 批准患者用药指南", "url": "https://dailymed.nlm.nih.gov/dailymed/medguide.cfm?setid=21628112-0c47-11df-95b3-498d55d89593", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "patient_medication_guide", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" }, { "id": "src_e7a7dd0d4191dbe9", "label": "FDA：TOPAMAX 托吡酯 NDA 020505 审评记录，记载 1996-12-24 批准", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20505S3_Topamax_clinphrmr.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_regulatory_document", "documentKind": "regulatory_review", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" }, { "id": "src_d68e97cb1529e5ef", "label": "FDA：TOPAMAX 托吡酯片 NDA 020505 与可撒服胶囊 NDA 020844 补充批准函（2012）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020505Orig1s050%2C020844Orig1s041ltr.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_regulatory_document", "documentKind": "regulatory_approval_letter", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" } ], "applicationNumber": "NDA 020505 / NDA 020844", "approvalTimeline": [ { "date": "1996-12-24", "title": { "zh": "TOPAMAX 托吡酯片美国初始批准", "en": "Initial U.S. approval of TOPAMAX topiramate tablets" }, "detail": { "zh": "FDA 审评记录明确记载 NDA 020505 于该日获批。", "en": "The FDA review record states that NDA 020505 was approved on this date." }, "source": { "id": "src_e7a7dd0d4191dbe9", "label": "FDA：TOPAMAX 托吡酯 NDA 020505 审评记录，记载 1996-12-24 批准", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20505S3_Topamax_clinphrmr.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_regulatory_document", "documentKind": "regulatory_review", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" } }, { "date": "2026-03-12", "title": { "zh": "当前品牌说明书生效日期", "en": "Current brand-label effective date" }, "detail": { "zh": "DailyMed SPL v30 汇总口服片与可撒服胶囊，并更新禁忌、严重过敏/皮肤反应及安全阅读内容。", "en": "DailyMed SPL v30 covers tablets and sprinkle capsules and updates contraindication, severe hypersensitivity/skin-reaction and safety reading." }, "source": { "id": "src_e3e6c3d2c730579e", "label": "DailyMed（NLM）：TOPAMAX 托吡酯当前美国品牌标签、Medication Guide、四种口服片与两种可撒服胶囊准确包装面板（2026-03 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=21628112-0c47-11df-95b3-498d55d89593", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "当前公开品牌标签", "en": "Current public brand label" }, "detail": { "zh": "本页展示 NDA 020505 四种普通片和 NDA 020844 两种可撒服胶囊；不代表实时供应。", "en": "This page displays four NDA 020505 tablets and two NDA 020844 sprinkle capsules; not evidence of live supply." } }, { "market": { "zh": "中国大陆、欧盟、日本及其他市场", "en": "Mainland China, EU, Japan and other markets" }, "status": { "zh": "当地商品名、批准、参比、包装和供应尚未逐市场确认", "en": "Local brand, approval, reference, pack and supply are not yet established market by market" }, "detail": { "zh": "不从美国 TOPAMAX 商品名、NDA、NDC 或包装外观推定其他市场状态。", "en": "No other-market status is inferred from the U.S. TOPAMAX name, NDA, NDC or package appearance." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "25、50、100、200 mg 是应该吃几片吗？", "en": "Do 25, 50, 100 and 200 mg tell me how many tablets to take?" }, "answer": { "zh": "不是。这些是每片含量；60 Tablets 是瓶中总片数。个人片数、时间和逐步调整只看准确处方并由负责治疗的专业人员确认。", "en": "No. These are amounts per tablet; 60 Tablets is the bottle count. Individual tablet count, timing and titration come only from the exact prescription and treating professional." } }, { "question": { "zh": "普通片能掰开或咀嚼吗？", "en": "Can the conventional tablet be split or chewed?" }, "answer": { "zh": "当前片剂为无刻痕包衣片，患者指南要求整片吞服并明确不能咀嚼。网页不把数学上的一半当作可分片许可。", "en": "The current tablets are unscored coated tablets, and the Medication Guide says to swallow them whole and not chew. The site does not treat arithmetic half as permission to split." } }, { "question": { "zh": "可撒服胶囊可以怎样阅读？", "en": "How should the sprinkle-capsule instructions be read?" }, "answer": { "zh": "它是不同剂型。说明书允许整粒吞服，或打开后把全部小球撒在一茶匙软食上立即吞下；不能咀嚼，也不能把混合物留到以后。具体是否适合个人仍以处方和专业确认准。", "en": "It is a different dosage form. The label permits swallowing it whole or opening it and placing all pellets on one teaspoon of soft food for immediate swallowing. Do not chew or store the mixture. Individual suitability still depends on the prescription and professional confirmation." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "dose-unit-literacy", "same-class-is-not-same-medicine", "interactions-are-not-a-home-scheduling-problem" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/topamax-topiramate/", "en": "https://origindrug.com/en/drugs/topamax-topiramate/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "imuran-azathioprine", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-09-04", "status": "published_traceable_archive" }, "names": { "brand": "IMURAN", "generic": "硫唑嘌呤片", "aliases": [ "IMURAN", "Imuran", "azathioprine", "azathioprine tablets", "硫唑嘌呤", "硫唑嘌呤片", "依木兰", "NDA 016324", "54766-590-10", "IMURAN 50" ], "marketBrandNames": [ { "name": "IMURAN", "market": { "zh": "美国", "en": "United States" }, "evidenceStatus": "current_regulatory_record", "note": { "zh": "当前品牌标签；监管记录不证明实时供应或个人适用。", "en": "Current brand label; a regulatory record does not prove live supply or individual suitability." }, "source": { "id": "src_1e8c7c6f11d3daa3", "label": "DailyMed（NLM）：IMURAN 硫唑嘌呤 50 mg 当前美国品牌标签、完整说明书与 100 片准确包装面板（2025-11 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=606101a0-6244-7eff-e053-2a91aa0acadd", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" } } ], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "免疫", "sourceArchiveMarket": "美国 DailyMed 当前 IMURAN 品牌标签列出硫唑嘌呤 50 mg 刻痕口服片、NDC 54766-590-10 与 100 片瓶装面板。美国 NDA、NDC 与品牌标签不等于其他市场批准、参比身份、实时供应、购买资格或个人适用性。", "dosageFormClass": "IMURAN 硫唑嘌呤刻痕口服片：每片 50 mg，100 片瓶装。50 mg 是每片含量，100 Tablets 是整瓶片数；刻痕只作准确产品外观线索，不自动生成掰片或减量许可。", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "1968（FDA 审评资料）", "archiveSponsorText": "Sebela Pharmaceuticals Inc.（当前美国品牌标签包装方）" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [ "IMURAN azathioprine", "IMURAN 50 mg", "硫唑嘌呤片", "依木兰" ], "excludedProductCues": [ "generic azathioprine", "AZASAN", "mercaptopurine", "6-mercaptopurine", "allopurinol", "febuxostat", "CELLCEPT", "TREXALL" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-imuran-azathioprine-tablet-50mg-100-bottle-ndc-5476659010", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国品牌标签（2025-11 修订；SPL v6）", "en": "Current U.S. DailyMed brand label (revised November 2025; SPL v6)" }, "dosageForm": { "zh": "IMURAN 硫唑嘌呤刻痕口服片", "en": "IMURAN azathioprine scored oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 54766-590-10", "pouchCode": null, "applicationNumber": "NDA 016324", "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片硫唑嘌呤 50 mg；100 片瓶装", "en": "Azathioprine 50 mg per tablet; 100-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=CA59010001%20Imuran.jpg&setid=606101a0-6244-7eff-e053-2a91aa0acadd&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "硫唑嘌呤", "en": "azathioprine" }, "value": 50, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、频次、疗程、分片或停药指令", "en": "labelled amount per tablet; not an individual's tablet count, frequency, course, splitting or stopping instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-04", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "黄色", "en": "yellow" }, "shape": { "zh": "双圆形刻痕片，约 11 mm", "en": "double-circle scored tablet, about 11 mm" }, "imprint": "IMURAN / 50", "scoreStatus": "scored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_1e8c7c6f11d3daa3", "label": "DailyMed（NLM）：IMURAN 硫唑嘌呤 50 mg 当前美国品牌标签、完整说明书与 100 片准确包装面板（2025-11 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=606101a0-6244-7eff-e053-2a91aa0acadd", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-imuran-azathioprine-tablet-50mg-100-bottle-ndc-5476659010", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=CA59010001%20Imuran.jpg&setid=606101a0-6244-7eff-e053-2a91aa0acadd&type=img", "alt": "IMURAN 硫唑嘌呤 50 mg、NDC 54766-590-10、100 片瓶装的 DailyMed 官方纸盒面板", "archiveMarket": "美国", "labelVersion": "DailyMed 当前美国品牌标签（2025-11 修订；SPL v6）", "presentation": "IMURAN 硫唑嘌呤：每片 50 mg，NDC 54766-590-10，100 片瓶装；黄色双圆形刻痕片，IMURAN / 50。", "notice": "此图只对应所引美国 50 mg、100 片瓶装标签面板，不代表通用药、其他硫唑嘌呤强度、注射剂、其他市场或实时库存，不用于鉴定真伪，也不授权分片、加减量、换药或停药。", "source": { "id": "src_1e8c7c6f11d3daa3", "label": "DailyMed（NLM）：IMURAN 硫唑嘌呤 50 mg 当前美国品牌标签、完整说明书与 100 片准确包装面板（2025-11 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=606101a0-6244-7eff-e053-2a91aa0acadd", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "IMURAN 说明书放大阅读：每片 50 mg、骨髓抑制、感染、基因与关键相互作用", "en": "IMURAN enlarged label: 50 mg per tablet, marrow suppression, infection, genetics and key interactions" }, "summary": { "zh": "50 mg 是每片硫唑嘌呤含量，100 Tablets 是整瓶片数，都不是个人用量。刻痕是本产品外观与身份线索；是否分片、如何使用或调整，必须回到准确处方、血细胞计数、肝肾功能、完整药单与治疗团队。", "en": "The 50 mg figure is the azathioprine amount per tablet and 100 Tablets is the bottle count; neither is an individual amount. The score is an appearance and identity clue. Splitting, use or adjustment requires the exact prescription, blood counts, liver and kidney function, complete medicine list and treating team." }, "checks": [ { "zh": "说明书有恶性肿瘤黑框警告，长期免疫抑制与淋巴瘤等风险相关。它不是适合自行开始、增加、轮换或与另一种免疫抑制剂叠加的普通药。", "en": "The label carries a boxed malignancy warning, and chronic immunosuppression is associated with lymphoma and other risks. This is not an ordinary medicine to self-start, increase, rotate or combine with another immunosuppressant." }, { "zh": "骨髓抑制可能造成白细胞、血小板或其他血细胞异常。说明书要求规律全血细胞计数（CBC）与血小板监测；异常出血或瘀青、发热或感染信号应尽快联系医疗团队，网页不能解读化验后替代处置。", "en": "Bone-marrow suppression can alter white cells, platelets and other blood cells. The label requires regular CBC and platelet monitoring. Unusual bleeding or bruising, fever or infection signs require prompt contact with the care team; the site cannot interpret tests and replace care." }, { "zh": "TPMT 或 NUDT15 活性降低可增加严重、危及生命的骨髓毒性风险；说明书同时明确基因型/表型检测不能替代血细胞计数。是否检测、如何解释及是否调整只由专业团队决定。", "en": "Reduced TPMT or NUDT15 activity can raise the risk of severe, life-threatening myelotoxicity. The label also states that genotype or phenotype testing cannot replace blood-count monitoring. Testing, interpretation and changes belong to the clinical team." }, { "zh": "严重细菌、病毒、真菌、原虫或机会性感染可能发生；新发神经症状还要考虑罕见但严重的 PML。不要只靠网页判断，也不要自行停用移植或免疫治疗药，须迅速联系负责团队。", "en": "Serious bacterial, viral, fungal, protozoal or opportunistic infection can occur. New neurological symptoms also require consideration of rare but serious PML. Do not rely on a website or self-stop transplant or immune therapy; promptly contact the responsible team." }, { "zh": "别嘌醇会抑制硫唑嘌呤灭活途径，非布司他与 IMURAN 同用在标签中不推荐；复方新诺明、氨基水杨酸类、利巴韦林及其他影响骨髓的药也需优先核对。网页不生成减量比例或错开时间表。", "en": "Allopurinol inhibits an azathioprine-inactivation pathway, and the label does not recommend concomitant febuxostat. Co-trimoxazole, aminosalicylates, ribavirin and other marrow-affecting medicines also require priority review. The site does not generate a reduction ratio or separation schedule." }, { "zh": "妊娠、备孕或哺乳需要尽早由相关专业团队权衡风险；2024 年 FDA 更新还涉及妊娠期肝内胆汁淤积症。不要自行停药或等待网页给出结论。", "en": "Pregnancy, pregnancy planning or breastfeeding requires early specialist risk-benefit review. A 2024 FDA update also addressed intrahepatic cholestasis of pregnancy. Do not self-stop or wait for a website conclusion." } ], "source": { "id": "src_1e8c7c6f11d3daa3", "label": "DailyMed（NLM）：IMURAN 硫唑嘌呤 50 mg 当前美国品牌标签、完整说明书与 100 片准确包装面板（2025-11 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=606101a0-6244-7eff-e053-2a91aa0acadd", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "作用机制阅读：嘌呤代谢线索不能生成个人剂量或联用方案", "en": "Mechanism reading: purine-metabolism clues cannot generate an individual dose or combination plan" }, "summary": { "zh": "硫唑嘌呤是 6-巯基嘌呤的咪唑衍生物，许多生物学效应与后者相似；标签同时说明其生化作用精确方式尚不清楚。它及代谢物影响嘌呤代谢和核酸相关过程，从而产生免疫抑制效应。机制不能单独证明个人适合、替代监测或决定和另一种免疫抑制剂联用。", "en": "Azathioprine is an imidazolyl derivative of 6-mercaptopurine and shares many biological effects with it; the label also says the precise mode of biochemical action is not known. It and its metabolites affect purine metabolism and nucleic-acid-related processes, contributing to immunosuppression. Mechanism alone cannot prove individual suitability, replace monitoring or decide combination with another immunosuppressant." }, "checks": [ { "zh": "TPMT、NUDT15 与黄嘌呤氧化酶是理解毒性和相互作用的重要通路，但不是公众自行套用的剂量计算器。", "en": "TPMT, NUDT15 and xanthine oxidase are important pathways for understanding toxicity and interactions, not public dose calculators." }, { "zh": "即使与其他药共同用于移植或免疫疾病，也不能按共同用途、mg 或机制词自行互换、叠加或轮换。", "en": "Even when medicines share transplant or immune-disease uses, shared purpose, milligrams or mechanism terms do not permit self-interchange, combination or rotation." }, { "zh": "老人、肝肾功能变化或多药使用者的风险判断必须结合诊断、实际处方、CBC 与完整药单；机制图不能替代监测和专业复核。", "en": "Risk assessment for older adults, changed liver or kidney function, or polypharmacy requires the diagnosis, actual prescription, CBC and complete medicine list. A mechanism diagram cannot replace monitoring and professional review." } ], "source": { "id": "src_1e8c7c6f11d3daa3", "label": "DailyMed（NLM）：IMURAN 硫唑嘌呤 50 mg 当前美国品牌标签、完整说明书与 100 片准确包装面板（2025-11 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=606101a0-6244-7eff-e053-2a91aa0acadd", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "IMURAN", "generic": "硫唑嘌呤片", "dosageFormClass": "IMURAN 硫唑嘌呤刻痕口服片：每片 50 mg，100 片瓶装。50 mg 是每片含量，100 Tablets 是整瓶片数；刻痕只作准确产品外观线索，不自动生成掰片或减量许可。" }, "labelSource": { "id": "src_1e8c7c6f11d3daa3", "label": "DailyMed（NLM）：IMURAN 硫唑嘌呤 50 mg 当前美国品牌标签、完整说明书与 100 片准确包装面板（2025-11 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=606101a0-6244-7eff-e053-2a91aa0acadd", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" }, "productRoutes": [ { "source": { "id": "src_1e8c7c6f11d3daa3", "label": "DailyMed（NLM）：IMURAN 硫唑嘌呤 50 mg 当前美国品牌标签、完整说明书与 100 片准确包装面板（2025-11 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=606101a0-6244-7eff-e053-2a91aa0acadd", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-09-04", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-09-04", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "IMURAN 是硫唑嘌呤的美国品牌档案。50 mg 是每片含量，100 Tablets 是整瓶数量，不是应该吃几片。它是需要专业管理的免疫抑制剂：恶性肿瘤黑框警告、骨髓抑制与血细胞计数、严重感染、肝脏/胰腺反应、妊娠风险，以及别嘌醇、非布司他、复方新诺明等相互作用都应优先核对；网页不生成个人剂量、分片、停换药或基因检测决定。", "history": "FDA 审评资料记载 IMURAN NDA 016324 于 1968 年批准。2024 年 FDA 批准函记录妊娠期肝内胆汁淤积症安全标签更新；当前 DailyMed SPL v6 于 2025-11 修订，保留恶性肿瘤黑框警告并详列骨髓抑制、感染、TPMT/NUDT15 与相互作用信息。", "sourceDocuments": [ { "id": "src_1e8c7c6f11d3daa3", "label": "DailyMed（NLM）：IMURAN 硫唑嘌呤 50 mg 当前美国品牌标签、完整说明书与 100 片准确包装面板（2025-11 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=606101a0-6244-7eff-e053-2a91aa0acadd", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" }, { "id": "src_9c8b683d5f0ba209", "label": "FDA：IMURAN 硫唑嘌呤 NDA 016324/S-040 补充批准函（2024）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/016324Orig1s040ltr.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_regulatory_document", "documentKind": "regulatory_approval_letter", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" }, { "id": "src_142cd58a6efb5266", "label": "FDA：类风湿关节炎审评资料表列 IMURAN NDA 016324 于 1968 年批准", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/125472Orig1s000MedR.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_regulatory_document", "documentKind": "regulatory_review", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" } ], "applicationNumber": "NDA 016324", "approvalTimeline": [ { "date": "1968", "title": { "zh": "IMURAN 美国批准年份", "en": "U.S. approval year for IMURAN" }, "detail": { "zh": "FDA 后续审评资料表把 IMURAN、NDA 016324 与 1968 年批准相连。", "en": "A later FDA review table links IMURAN, NDA 016324 and approval in 1968." }, "source": { "id": "src_142cd58a6efb5266", "label": "FDA：类风湿关节炎审评资料表列 IMURAN NDA 016324 于 1968 年批准", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/125472Orig1s000MedR.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_regulatory_document", "documentKind": "regulatory_review", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" } }, { "date": "2024-06-13", "title": { "zh": "FDA 妊娠安全标签补充批准", "en": "FDA pregnancy-safety labelling supplement approval" }, "detail": { "zh": "FDA 批准函记录妊娠期肝内胆汁淤积症相关标签更新。", "en": "The FDA letter records a label update concerning intrahepatic cholestasis of pregnancy." }, "source": { "id": "src_9c8b683d5f0ba209", "label": "FDA：IMURAN 硫唑嘌呤 NDA 016324/S-040 补充批准函（2024）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/016324Orig1s040ltr.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_regulatory_document", "documentKind": "regulatory_approval_letter", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" } }, { "date": "2025-11-08", "title": { "zh": "当前 DailyMed 品牌标签生效", "en": "Current DailyMed brand label effective" }, "detail": { "zh": "SPL v6 列出 50 mg、100 片瓶装产品与现行安全内容。", "en": "SPL v6 lists the 50 mg, 100-tablet bottle and current safety content." }, "source": { "id": "src_1e8c7c6f11d3daa3", "label": "DailyMed（NLM）：IMURAN 硫唑嘌呤 50 mg 当前美国品牌标签、完整说明书与 100 片准确包装面板（2025-11 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=606101a0-6244-7eff-e053-2a91aa0acadd", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "当前公开品牌标签", "en": "Current public brand label" }, "detail": { "zh": "本页展示一个准确 50 mg、100 片瓶装标签面板；不证明实时供应。", "en": "This page displays one exact 50 mg, 100-tablet label panel; not proof of live supply." } }, { "market": { "zh": "中国大陆及其他市场", "en": "Mainland China and other markets" }, "status": { "zh": "当地批准、参比、商品名、包装和供应尚未逐市场确认", "en": "Local approval, reference, brand, pack and supply are not yet established market by market" }, "detail": { "zh": "不从美国 NDA、NDC 或包装推定其他市场状态。", "en": "No other-market status is inferred from the U.S. NDA, NDC or pack." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "做了 TPMT/NUDT15 基因检测就不用查血了吗？", "en": "Does TPMT/NUDT15 testing remove the need for blood counts?" }, "answer": { "zh": "不能。当前说明书明确检测不能替代 CBC 监测；检测和化验都需要治疗团队结合实际情况解释。", "en": "No. The current label explicitly says testing cannot replace CBC monitoring; both require interpretation by the treating team." } }, { "question": { "zh": "有刻痕就能自己掰半片吗？", "en": "Does the score mean I can halve the tablet myself?" }, "answer": { "zh": "不能这样推断。刻痕用于核对准确产品外观；个人是否分片、如何调整只看准确处方和专业确认。", "en": "That cannot be inferred. The score helps identify the exact product; individual splitting and adjustment require the exact prescription and professional confirmation." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "dose-unit-literacy", "same-class-is-not-same-medicine", "interactions-are-not-a-home-scheduling-problem" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/imuran-azathioprine/", "en": "https://origindrug.com/en/drugs/imuran-azathioprine/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "prograf-tacrolimus", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-09-04", "status": "published_traceable_archive" }, "names": { "brand": "PROGRAF", "generic": "他克莫司胶囊", "aliases": [ "PROGRAF", "Prograf", "tacrolimus", "tacrolimus capsules", "他克莫司", "他克莫司胶囊", "普乐可复", "NDA 050708", "0469-0607-73", "0469-0617-73", "0469-0657-73" ], "marketBrandNames": [ { "name": "PROGRAF", "market": { "zh": "美国", "en": "United States" }, "evidenceStatus": "current_regulatory_record", "note": { "zh": "当前品牌标签；监管记录不证明实时供应或个人适用。", "en": "Current brand label; a regulatory record does not prove live supply or individual suitability." }, "source": { "id": "src_eaa6bb4f067f7f7b", "label": "DailyMed（NLM）：PROGRAF 他克莫司当前美国品牌标签、完整说明书与三个准确胶囊包装面板（SPL v30；2023-08）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=7f667de1-9dfa-4bd6-8ba0-15ee2d78873b", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" } } ], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "免疫", "sourceArchiveMarket": "美国 DailyMed 当前 PROGRAF 品牌标签列出普通释放他克莫司胶囊 0.5 mg、1 mg、5 mg 三种强度及各自 100 粒瓶装 NDC。本页不从美国记录外推中国大陆或其他市场的批准、商品名、参比身份、供应、购买资格或个人适用性。", "dosageFormClass": "PROGRAF 普通释放他克莫司硬胶囊：0.5 mg、1 mg、5 mg 均为每粒含量，各展示 100 粒瓶装；不同强度、普通释放与缓释、胶囊与颗粒/注射剂不能只按名称或毫克数自行互换。", "dosageFormClassCode": "oral_modified_release", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "1994-04-08（FDA 审评资料）", "archiveSponsorText": "Astellas Pharma US, Inc." }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [ "PROGRAF tacrolimus", "PROGRAF capsules", "他克莫司胶囊", "普乐可复" ], "excludedProductCues": [ "generic tacrolimus", "ASTAGRAF XL", "ENVARSUS XR", "MODIGRAF", "tacrolimus extended-release", "tacrolimus ointment", "PROTOPIC", "PROGRAF Granules", "tacrolimus injection" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-prograf-tacrolimus-capsule-0-5mg-100-bottle-ndc-0469060773", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国品牌标签（SPL v30；2023-08）", "en": "Current U.S. DailyMed brand label (SPL v30; August 2023)" }, "dosageForm": { "zh": "PROGRAF 他克莫司普通释放硬胶囊", "en": "PROGRAF tacrolimus immediate-release hard capsule" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 0469-0607-73", "pouchCode": null, "applicationNumber": "NDA 050708", "presentationRole": null, "primaryStrengthBasisCode": "per_capsule", "primaryDisplay": { "zh": "每粒他克莫司 0.5 mg；100 粒瓶装", "en": "Tacrolimus 0.5 mg per capsule; 100-capsule bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?id=865678&name=image-23.jpg", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "他克莫司", "en": "tacrolimus" }, "value": 0.5, "unit": "mg", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒标签标示量；不是个人颗数、频次、间隔、疗程或换算指令", "en": "labelled amount per capsule; not an individual's capsule count, frequency, interval, course or conversion instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-04", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "physicalClues": { "color": { "zh": "浅黄色", "en": "light yellow" }, "shape": { "zh": "长圆硬胶囊，约 11 mm", "en": "oblong hard capsule, about 11 mm" }, "imprint": "f / 607 / 0.5 mg", "scoreStatus": "not_scored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_eaa6bb4f067f7f7b", "label": "DailyMed（NLM）：PROGRAF 他克莫司当前美国品牌标签、完整说明书与三个准确胶囊包装面板（SPL v30；2023-08）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=7f667de1-9dfa-4bd6-8ba0-15ee2d78873b", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-prograf-tacrolimus-capsule-1mg-100-bottle-ndc-0469061773", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国品牌标签（SPL v30；2023-08）", "en": "Current U.S. DailyMed brand label (SPL v30; August 2023)" }, "dosageForm": { "zh": "PROGRAF 他克莫司普通释放硬胶囊", "en": "PROGRAF tacrolimus immediate-release hard capsule" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 0469-0617-73", "pouchCode": null, "applicationNumber": "NDA 050708", "presentationRole": null, "primaryStrengthBasisCode": "per_capsule", "primaryDisplay": { "zh": "每粒他克莫司 1 mg；100 粒瓶装", "en": "Tacrolimus 1 mg per capsule; 100-capsule bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?id=865678&name=image-24.jpg", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "他克莫司", "en": "tacrolimus" }, "value": 1, "unit": "mg", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒标签标示量；不是个人颗数、频次、间隔、疗程或换算指令", "en": "labelled amount per capsule; not an individual's capsule count, frequency, interval, course or conversion instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-04", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "physicalClues": { "color": { "zh": "白色", "en": "white" }, "shape": { "zh": "长圆硬胶囊，约 11 mm", "en": "oblong hard capsule, about 11 mm" }, "imprint": "f / 617 / 1 mg", "scoreStatus": "not_scored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_eaa6bb4f067f7f7b", "label": "DailyMed（NLM）：PROGRAF 他克莫司当前美国品牌标签、完整说明书与三个准确胶囊包装面板（SPL v30；2023-08）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=7f667de1-9dfa-4bd6-8ba0-15ee2d78873b", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-prograf-tacrolimus-capsule-5mg-100-bottle-ndc-0469065773", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国品牌标签（SPL v30；2023-08）", "en": "Current U.S. DailyMed brand label (SPL v30; August 2023)" }, "dosageForm": { "zh": "PROGRAF 他克莫司普通释放硬胶囊", "en": "PROGRAF tacrolimus immediate-release hard capsule" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 0469-0657-73", "pouchCode": null, "applicationNumber": "NDA 050708", "presentationRole": null, "primaryStrengthBasisCode": "per_capsule", "primaryDisplay": { "zh": "每粒他克莫司 5 mg；100 粒瓶装", "en": "Tacrolimus 5 mg per capsule; 100-capsule bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?id=865678&name=image-25.jpg", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "他克莫司", "en": "tacrolimus" }, "value": 5, "unit": "mg", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒标签标示量；不是个人颗数、频次、间隔、疗程或换算指令", "en": "labelled amount per capsule; not an individual's capsule count, frequency, interval, course or conversion instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-04", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "physicalClues": { "color": { "zh": "灰红色", "en": "grayish red" }, "shape": { "zh": "长圆硬胶囊，约 14 mm", "en": "oblong hard capsule, about 14 mm" }, "imprint": "f / 657 / 5 mg", "scoreStatus": "not_scored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_eaa6bb4f067f7f7b", "label": "DailyMed（NLM）：PROGRAF 他克莫司当前美国品牌标签、完整说明书与三个准确胶囊包装面板（SPL v30；2023-08）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=7f667de1-9dfa-4bd6-8ba0-15ee2d78873b", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-prograf-tacrolimus-capsule-1mg-100-bottle-ndc-0469061773", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?id=865678&name=image-24.jpg", "alt": "PROGRAF 他克莫司 1 mg、NDC 0469-0617-73、100 粒瓶装的 DailyMed 官方包装面板", "archiveMarket": "美国", "labelVersion": "DailyMed 当前美国品牌标签（SPL v30；2023-08）", "presentation": "PROGRAF 他克莫司普通释放胶囊：每粒 1 mg，NDC 0469-0617-73，100 粒瓶装；白色长圆胶囊，f / 617 / 1 mg。", "notice": "此图只对应所引美国 1 mg、100 粒瓶装面板。页面另将 0.5 mg 与 5 mg 包装逐项分开；图片不用于鉴定真伪，也不能证明实时库存，不授权换规格、换剂型、开胶囊或调整用法。", "source": { "id": "src_eaa6bb4f067f7f7b", "label": "DailyMed（NLM）：PROGRAF 他克莫司当前美国品牌标签、完整说明书与三个准确胶囊包装面板（SPL v30；2023-08）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=7f667de1-9dfa-4bd6-8ba0-15ee2d78873b", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "PROGRAF 说明书放大阅读：每粒含量、血药浓度、肾毒性、感染与不可互换", "en": "PROGRAF enlarged label: per-capsule strength, blood levels, nephrotoxicity, infection and non-interchangeability" }, "summary": { "zh": "包装上的 0.5 mg、1 mg、5 mg 是每粒他克莫司含量；100 Capsules 是瓶内数量。个人颗数、间隔与目标血药浓度不能从包装数字推出。每次拿到新包装，都应核对品牌、释放方式、强度、外观和处方；不同他克莫司产品不得自行替换。", "en": "The 0.5 mg, 1 mg and 5 mg figures are tacrolimus amounts per capsule; 100 Capsules is the bottle count. Individual capsule counts, intervals and target blood levels cannot be inferred from pack numbers. With each new supply, check brand, release form, strength, appearance and prescription; tacrolimus products must not be self-substituted." }, "checks": [ { "zh": "说明书明确 PROGRAF 普通释放产品与缓释他克莫司不可互换；配药或替换错误曾导致排斥或暴露过高/过低。看到 ASTAGRAF XL、ENVARSUS XR、颗粒剂、注射剂或不同外观时，应在使用前联系移植团队或药师。", "en": "The label states that immediate-release PROGRAF is not interchangeable with extended-release tacrolimus. Dispensing or substitution errors have led to rejection or under-/overexposure. Contact the transplant team or pharmacist before use when ASTAGRAF XL, ENVARSUS XR, granules, injection or a different appearance is supplied." }, { "zh": "他克莫司需要结合全血谷浓度和临床情况监测；网页不能从一次化验、体重、年龄、基因或包装强度计算个人颗数、目标范围或调整量。", "en": "Tacrolimus requires whole-blood trough monitoring together with clinical context. The site cannot use one result, weight, age, genetics or pack strength to calculate capsule count, target range or adjustment." }, { "zh": "肾毒性、高钾、低镁、高血压、新发糖尿病、神经毒性和心律相关风险均需专业监测。尿量明显变化、严重头痛、意识或视觉异常、抽搐等急性问题应走当地紧急医疗与移植团队通道。", "en": "Nephrotoxicity, hyperkalaemia, hypomagnesaemia, hypertension, new-onset diabetes, neurotoxicity and rhythm-related risks require professional monitoring. Marked urine changes, severe headache, altered awareness or vision, seizure or another acute concern requires local urgent care and the transplant team." }, { "zh": "免疫抑制会增加严重感染、机会性感染、淋巴瘤和其他恶性肿瘤风险；发热、寒战、咳嗽、皮肤异常或新神经症状不能只靠网页判断，也不要自行停药。", "en": "Immunosuppression increases serious and opportunistic infection, lymphoma and other malignancy risks. Fever, chills, cough, skin change or new neurological symptoms cannot be assessed by a webpage, and treatment must not be self-stopped." }, { "zh": "强 CYP3A 抑制剂或诱导剂、其他肾毒性药、钾升高药、活疫苗及葡萄柚都可能影响风险或暴露；请一次性交给药师核对处方药、非处方药、中草药、补充剂、饮食与近期变更，不要自行错开或停换。", "en": "Strong CYP3A inhibitors or inducers, other nephrotoxic medicines, potassium-raising agents, live vaccines and grapefruit can alter exposure or risk. Give the pharmacist all prescriptions, OTC medicines, herbs, supplements, diet and recent changes together; do not self-separate, stop or switch." }, { "zh": "胶囊不应打开或压碎；颗粒剂有独立配制说明，不能把胶囊内容物当颗粒剂使用。妊娠、备孕、哺乳或接触粉末也需提前让专业团队评估。", "en": "Capsules should not be opened or crushed. Granules have separate preparation instructions and capsule contents are not granules. Pregnancy, pregnancy planning, breastfeeding or powder exposure also requires advance professional review." } ], "source": { "id": "src_eaa6bb4f067f7f7b", "label": "DailyMed（NLM）：PROGRAF 他克莫司当前美国品牌标签、完整说明书与三个准确胶囊包装面板（SPL v30；2023-08）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=7f667de1-9dfa-4bd6-8ba0-15ee2d78873b", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "作用机制阅读：抑制钙调神经磷酸酶，不等于可以自行按机制换药", "en": "Mechanism reading: calcineurin inhibition does not permit mechanism-based self-switching" }, "summary": { "zh": "他克莫司与细胞内 FKBP-12 结合，形成的复合物抑制钙调神经磷酸酶，影响 NF-AT 等信号以及多种细胞因子表达，最终抑制 T 淋巴细胞激活和增殖。机制解释免疫抑制方向，却不能决定个人剂量、目标血药浓度、换用环孢素或改成缓释制剂。", "en": "Tacrolimus binds intracellular FKBP-12; the resulting complex inhibits calcineurin, affects NF-AT and other signalling and multiple cytokines, and ultimately suppresses T-lymphocyte activation and proliferation. This explains the immunosuppressive direction but cannot determine an individual dose, target blood level, switch to cyclosporine or conversion to an extended-release product." }, "checks": [ { "zh": "同为免疫抑制剂、同一通路或同一通用名，不代表剂型、暴露、风险和监测可以互换。", "en": "The same immune purpose, pathway or generic name does not make dosage form, exposure, risks or monitoring interchangeable." }, { "zh": "CYP3A 与转运相关相互作用可能显著改变暴露，但网页不会生成停药、错开时间、减量比例或换药方案。", "en": "CYP3A- and transporter-related interactions can materially change exposure, but the site generates no stopping, separation, reduction or switching plan." }, { "zh": "老人、多药使用、肝肾功能变化或感染时，必须将实际包装、处方、血药浓度与化验一起交给移植团队复核。", "en": "For older adults, polypharmacy, changed liver or kidney function or infection, the actual packs, prescription, blood levels and laboratory results require transplant-team review together." } ], "source": { "id": "src_eaa6bb4f067f7f7b", "label": "DailyMed（NLM）：PROGRAF 他克莫司当前美国品牌标签、完整说明书与三个准确胶囊包装面板（SPL v30；2023-08）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=7f667de1-9dfa-4bd6-8ba0-15ee2d78873b", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "PROGRAF", "generic": "他克莫司胶囊", "dosageFormClass": "PROGRAF 普通释放他克莫司硬胶囊：0.5 mg、1 mg、5 mg 均为每粒含量，各展示 100 粒瓶装；不同强度、普通释放与缓释、胶囊与颗粒/注射剂不能只按名称或毫克数自行互换。" }, "labelSource": { "id": "src_eaa6bb4f067f7f7b", "label": "DailyMed（NLM）：PROGRAF 他克莫司当前美国品牌标签、完整说明书与三个准确胶囊包装面板（SPL v30；2023-08）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=7f667de1-9dfa-4bd6-8ba0-15ee2d78873b", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" }, "productRoutes": [ { "source": { "id": "src_eaa6bb4f067f7f7b", "label": "DailyMed（NLM）：PROGRAF 他克莫司当前美国品牌标签、完整说明书与三个准确胶囊包装面板（SPL v30；2023-08）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=7f667de1-9dfa-4bd6-8ba0-15ee2d78873b", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-09-04", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-09-04", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "PROGRAF 是他克莫司普通释放胶囊的美国品牌档案。0.5 mg、1 mg、5 mg 都是每粒含量，100 Capsules 是整瓶数量，不是个人应该吃几颗。它是窄治疗窗免疫抑制剂，普通释放与缓释产品不可自行替换；血药浓度、肾功能、血糖、电解质、感染、神经症状和完整药单都须由移植团队持续管理。", "history": "FDA 审评资料记录 PROGRAF 胶囊 NDA 050708 于 1994-04-08 获批。当前 DailyMed SPL v30 列出 0.5 mg、1 mg、5 mg 普通释放胶囊、三个 100 粒瓶装面板，并明确剂型不可自行互换以及重要监测与相互作用边界。", "sourceDocuments": [ { "id": "src_eaa6bb4f067f7f7b", "label": "DailyMed（NLM）：PROGRAF 他克莫司当前美国品牌标签、完整说明书与三个准确胶囊包装面板（SPL v30；2023-08）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=7f667de1-9dfa-4bd6-8ba0-15ee2d78873b", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" }, { "id": "src_5bd4100118700705", "label": "FDA：PROGRAF 名称审评资料，记录胶囊 NDA 050708 于 1994-04-08 获批", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210115Orig1s000NameR.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_regulatory_document", "documentKind": "regulatory_review", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" } ], "applicationNumber": "NDA 050708", "approvalTimeline": [ { "date": "1994-04-08", "title": { "zh": "PROGRAF 胶囊美国批准", "en": "U.S. approval of PROGRAF capsules" }, "detail": { "zh": "FDA 审评资料记录普通释放胶囊 NDA 050708 于该日获批。", "en": "The FDA review records approval of immediate-release capsules under NDA 050708 on this date." }, "source": { "id": "src_5bd4100118700705", "label": "FDA：PROGRAF 名称审评资料，记录胶囊 NDA 050708 于 1994-04-08 获批", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210115Orig1s000NameR.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_regulatory_document", "documentKind": "regulatory_review", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" } }, { "date": "2023-08-25", "title": { "zh": "当前 DailyMed 标签版本生效", "en": "Current DailyMed label effective" }, "detail": { "zh": "SPL v30 列出三个胶囊强度、准确包装和现行安全信息。", "en": "SPL v30 lists the three capsule strengths, exact packs and current safety information." }, "source": { "id": "src_eaa6bb4f067f7f7b", "label": "DailyMed（NLM）：PROGRAF 他克莫司当前美国品牌标签、完整说明书与三个准确胶囊包装面板（SPL v30；2023-08）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=7f667de1-9dfa-4bd6-8ba0-15ee2d78873b", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "当前公开品牌标签", "en": "Current public brand label" }, "detail": { "zh": "展示三个准确普通释放胶囊瓶装；不证明实时供应。", "en": "Three exact immediate-release capsule bottles are displayed; not proof of live supply." } }, { "market": { "zh": "中国大陆及其他市场", "en": "Mainland China and other markets" }, "status": { "zh": "当地批准、商品名、参比、包装和供应尚未逐市场确认", "en": "Local approval, brand, reference, pack and supply not yet established market by market" }, "detail": { "zh": "不从美国 NDA、NDC 或包装推定其他市场状态。", "en": "No other-market status is inferred from the U.S. NDA, NDC or pack." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "同样叫他克莫司，普通释放和缓释能自己换吗？", "en": "Can immediate- and extended-release tacrolimus be switched by myself?" }, "answer": { "zh": "不能。当前标签明确说明不可互换，转换必须由医生监督并结合血药浓度等监测。", "en": "No. The current label states they are not interchangeable; conversion requires physician supervision and monitoring including blood levels." } }, { "question": { "zh": "1 mg 胶囊是不是每次吃一粒？", "en": "Does a 1 mg capsule mean one capsule each time?" }, "answer": { "zh": "不是。1 mg 只说明每粒含量；个人颗数和间隔由准确处方及移植团队依据监测决定。", "en": "No. 1 mg is the amount per capsule; the exact prescription and transplant team determine capsule count and interval using monitoring." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "dose-unit-literacy", "same-class-is-not-same-medicine", "interactions-are-not-a-home-scheduling-problem" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/prograf-tacrolimus/", "en": "https://origindrug.com/en/drugs/prograf-tacrolimus/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "lialda-mesalamine", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-09-05", "status": "published_traceable_archive" }, "names": { "brand": "LIALDA", "generic": "美沙拉秦延迟释放片", "aliases": [ "Lialda", "mesalamine", "mesalazine", "mesalamine delayed-release tablets", "美沙拉秦", "美沙拉秦延迟释放片", "美沙拉嗪", "美沙拉嗪延迟释放片", "NDA 022000", "NDC 54092-476-12", "LIALDA", "54092-476-12", "S476" ], "marketBrandNames": [ { "name": "LIALDA", "market": { "zh": "美国", "en": "United States" }, "evidenceStatus": "current_regulatory_record", "note": { "zh": "当前品牌标签；监管记录不证明实时库存、价格或个人适用。", "en": "Current brand label; a regulatory record does not prove live stock, price or individual suitability." }, "source": { "id": "src_2cd8e9973cb2ee63", "label": "DailyMed（NLM）：LIALDA 美沙拉秦 1.2 g 延迟释放片当前美国品牌标签、说明书与 120 片瓶装面板（SPL v49；2026-03-24）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=3098a080-be86-4265-9818-7fc4beab77b7", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-05", "reviewedAt": "2026-09-05" } } ], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "消化系统", "sourceArchiveMarket": "本页只建立美国 LIALDA 当前品牌标签档案：NDA 022000、每片 1.2 g、NDC 54092-476-12、120 片瓶装。美国记录不外推中国大陆或其他市场的批准、商品名、参比身份、供应、价格、购买资格或个人适用性。", "dosageFormClass": "LIALDA 是美沙拉秦延迟释放片，其包衣在约 pH 6.8 或以上开始分解，随后延长释放。ASACOL HD、PENTASA、APRISO、DELZICOL、栓剂、灌肠剂以及不同厂牌属于不同准确产品，不能只按共同成分或总毫克数自行互换。", "dosageFormClassCode": "oral_modified_release", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "2007-01-16（LIALDA NDA 022000 初始批准；标签中的 1987 是美沙拉秦美国初始批准信息）", "archiveSponsorText": "Takeda Pharmaceuticals America, Inc." }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [ "LIALDA", "LIALDA mesalamine", "mesalamine delayed-release tablets", "美沙拉秦延迟释放片" ], "excludedProductCues": [ "ASACOL HD", "PENTASA", "APRISO", "DELZICOL", "CANASA", "ROWASA", "generic mesalamine", "mesalamine suppository", "mesalamine enema" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-lialda-mesalamine-delayed-release-tablet-1-2g-120-bottle-ndc-5409247612", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国品牌标签（SPL v49；2026-03-24）", "en": "Current U.S. DailyMed brand label (SPL v49; 24 March 2026)" }, "dosageForm": { "zh": "LIALDA 美沙拉秦延迟释放片", "en": "LIALDA mesalamine delayed-release tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 54092-476-12", "pouchCode": null, "applicationNumber": "NDA 022000", "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片美沙拉秦 1.2 g；120 片瓶装", "en": "Mesalamine 1.2 g per tablet; 120-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=lialda-02.jpg&setid=3098a080-be86-4265-9818-7fc4beab77b7&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "美沙拉秦", "en": "mesalamine" }, "value": 1.2, "unit": "g", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、频次、疗程或与其他美沙拉秦制剂的换算值", "en": "labelled amount per tablet; not an individual's tablet count, frequency, course or conversion to another mesalamine product" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 120, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-05", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "current_regulatory_listing_not_live_stock", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 120, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "红棕色", "en": "red-brown" }, "shape": { "zh": "椭圆形片", "en": "ellipsoidal tablet" }, "imprint": "S476", "scoreStatus": "label_says_do_not_split_or_crush", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_2cd8e9973cb2ee63", "label": "DailyMed（NLM）：LIALDA 美沙拉秦 1.2 g 延迟释放片当前美国品牌标签、说明书与 120 片瓶装面板（SPL v49；2026-03-24）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=3098a080-be86-4265-9818-7fc4beab77b7", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-05", "reviewedAt": "2026-09-05" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-lialda-mesalamine-delayed-release-tablet-1-2g-120-bottle-ndc-5409247612", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=lialda-02.jpg&setid=3098a080-be86-4265-9818-7fc4beab77b7&type=img", "alt": "LIALDA 美沙拉秦 1.2 g、NDC 54092-476-12、120 片瓶装的 DailyMed 官方包装面板", "archiveMarket": "美国", "labelVersion": "DailyMed SPL v49；2026-03-24", "presentation": "红棕色椭圆片，S476；每片 1.2 g，120 片瓶装。", "notice": "只对应所引美国当前准确包装。外观与刻印不用于鉴定真伪，也不能证明实时库存；标签要求整片吞服，不因可见刻痕或总毫克数推导掰片、换药或个人用法。", "source": { "id": "src_2cd8e9973cb2ee63", "label": "DailyMed（NLM）：LIALDA 美沙拉秦 1.2 g 延迟释放片当前美国品牌标签、说明书与 120 片瓶装面板（SPL v49；2026-03-24）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=3098a080-be86-4265-9818-7fc4beab77b7", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-05", "reviewedAt": "2026-09-05" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "LIALDA 说明书放大阅读：每片含量、整片吞服、肾功能与相互作用", "en": "LIALDA enlarged label: per-tablet amount, swallowing whole, kidney function and interactions" }, "summary": { "zh": "包装的 1.2 g 是每片美沙拉秦含量，120 Tablets 是瓶内片数。应整片吞服，不能掰开或压碎；个人片数、频次、疗程及能否改用其他美沙拉秦产品，不能从包装数字或网页推导。", "en": "The 1.2 g figure is mesalamine per tablet and 120 Tablets is the bottle count. Swallow tablets whole; do not split or crush them. Individual tablet count, frequency, course and any switch to other mesalamine products cannot be inferred from pack numbers or this page." }, "checks": [ { "zh": "开始前及使用期间需按专业安排评估肾功能；既往肾病、老人、脱水或同时使用可能损害肾脏的药物时更要主动核对。出现尿量明显变化、肿胀或严重不适应及时就医，不要自行停换。", "en": "Kidney function requires professional assessment before and during treatment. Prior kidney disease, older age, dehydration or concurrent nephrotoxic medicines needs extra review. Marked urine change, swelling or severe illness needs prompt care; do not self-stop or switch." }, { "zh": "NSAID 等肾毒性药物可能增加肾脏不良反应风险；不要只在网页上把药错开，应把处方药、非处方止痛药、中草药和补充剂一次性交给医生或药师核对。", "en": "NSAIDs and other nephrotoxic medicines may increase renal adverse-reaction risk. Do not merely separate them using a webpage; give prescriptions, OTC pain medicines, herbs and supplements together to a doctor or pharmacist." }, { "zh": "与硫唑嘌呤或 6-巯基嘌呤同用可能增加血液病风险，需要专业核对全血细胞计数和血小板；发热、异常瘀青、出血或明显乏力不应用网页自行判断。", "en": "Azathioprine or 6-mercaptopurine may increase blood-dyscrasia risk and requires professional review of complete blood counts and platelets. Fever, unusual bruising, bleeding or marked fatigue cannot be self-assessed on a webpage." }, { "zh": "65 岁及以上人群标签报告血液病发生率较高；老年人还常有肾功能变化和多药使用，应把实际药盒、处方和化验一起复核，而不是按年龄自行减片。", "en": "The label reports a higher incidence of blood dyscrasias in people aged 65 and older. Kidney change and polypharmacy are also common; review actual packs, prescriptions and tests together rather than self-reducing by age." }, { "zh": "急性不耐受综合征、严重皮肤反应、胸痛、呼吸困难、明显腹痛/血便加重或其他急性异常需要及时医疗评估；网页不作停药或急症排除决定。", "en": "Acute intolerance syndrome, severe skin reactions, chest pain, breathing difficulty, marked worsening abdominal pain/bloody stool or another acute change requires prompt medical assessment; this page does not decide stopping or exclude emergencies." } ], "source": { "id": "src_2cd8e9973cb2ee63", "label": "DailyMed（NLM）：LIALDA 美沙拉秦 1.2 g 延迟释放片当前美国品牌标签、说明书与 120 片瓶装面板（SPL v49；2026-03-24）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=3098a080-be86-4265-9818-7fc4beab77b7", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-05", "reviewedAt": "2026-09-05" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "释放结构阅读：pH 依赖包衣不等于所有美沙拉秦制剂可互换", "en": "Release design: a pH-dependent coat does not make mesalamine products interchangeable" }, "summary": { "zh": "LIALDA 片剂采用 pH 依赖聚合物包衣；标签描述包衣在 pH 6.8 或以上、通常到达末端回肠时开始分解，之后美沙拉秦延迟并延长释放。该机制用于理解准确产品，不能生成掰片、压碎、加减片数或改用其他制剂的方案。", "en": "LIALDA uses a pH-dependent polymer coat. The label describes breakdown at pH 6.8 or above, normally in the terminal ileum, followed by delayed and extended mesalamine release. This explains the exact product but creates no plan to split, crush, change tablet count or switch formulation." }, "checks": [ { "zh": "共同成分不等于相同释放位置、剂型、规格、辅料或标签；ASACOL HD、PENTASA、APRISO、DELZICOL 及直肠制剂要分别核对。", "en": "A shared ingredient does not mean the same release site, form, strength, excipients or label. ASACOL HD, PENTASA, APRISO, DELZICOL and rectal products require separate checks." }, { "zh": "看到完整或部分片壳样物质、吞咽困难或新包装时，应保存包装并询问专业人员；不要自行压碎、浸泡或改用另一剂型。", "en": "If intact or partial tablet-shell material is seen, swallowing is difficult or a new pack arrives, keep the pack and ask a professional; do not crush, soak or switch form yourself." }, { "zh": "疾病活动、症状变化、检查结果与肾功能由临床团队综合判断；释放原理不能替代复诊，也不能决定个人片数、疗程或停换药。", "en": "Disease activity, symptom change, test results and kidney function require integrated clinical review. Release design does not replace follow-up or determine an individual's tablet count, course, stopping or switching." } ], "source": { "id": "src_2cd8e9973cb2ee63", "label": "DailyMed（NLM）：LIALDA 美沙拉秦 1.2 g 延迟释放片当前美国品牌标签、说明书与 120 片瓶装面板（SPL v49；2026-03-24）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=3098a080-be86-4265-9818-7fc4beab77b7", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-05", "reviewedAt": "2026-09-05" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "LIALDA", "generic": "美沙拉秦延迟释放片", "dosageFormClass": "LIALDA 是美沙拉秦延迟释放片，其包衣在约 pH 6.8 或以上开始分解，随后延长释放。ASACOL HD、PENTASA、APRISO、DELZICOL、栓剂、灌肠剂以及不同厂牌属于不同准确产品，不能只按共同成分或总毫克数自行互换。" }, "labelSource": { "id": "src_2cd8e9973cb2ee63", "label": "DailyMed（NLM）：LIALDA 美沙拉秦 1.2 g 延迟释放片当前美国品牌标签、说明书与 120 片瓶装面板（SPL v49；2026-03-24）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=3098a080-be86-4265-9818-7fc4beab77b7", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-05", "reviewedAt": "2026-09-05" }, "productRoutes": [ { "source": { "id": "src_2cd8e9973cb2ee63", "label": "DailyMed（NLM）：LIALDA 美沙拉秦 1.2 g 延迟释放片当前美国品牌标签、说明书与 120 片瓶装面板（SPL v49；2026-03-24）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=3098a080-be86-4265-9818-7fc4beab77b7", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-05", "reviewedAt": "2026-09-05" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-09-05", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_21a6177cab38ae20", "label": "FDA Drugs@FDA：LIALDA NDA 022000 产品与监管记录入口", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=022000", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-05", "reviewedAt": "2026-09-05" }, "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-09-05", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-09-05", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "LIALDA 是美沙拉秦延迟释放口服片的美国品牌档案。1.2 g 是每片含量，不是个人片数；120 Tablets 才是整瓶片数，也不是个人应该吃多少片。片剂应整片吞服，不能掰开或压碎；不同美沙拉秦制剂的释放位置、剂型、强度和标签不同，不能只按同成分或总毫克数自行替换。肾功能、完整药单和老年人的血象风险需由医生或药师结合实际情况核对。", "history": "FDA 资料记录 LIALDA 于 2007-01-16 以 NDA 022000 获批，用于轻至中度溃疡性结肠炎的相关适应证。当前 DailyMed SPL v49 于 2026-03-24 生效，列出 1.2 g 延迟释放片和 120 片瓶装；1987 是标签中的美沙拉秦美国初始批准年份，不应误写为 LIALDA 品牌获批年份。", "sourceDocuments": [ { "id": "src_2cd8e9973cb2ee63", "label": "DailyMed（NLM）：LIALDA 美沙拉秦 1.2 g 延迟释放片当前美国品牌标签、说明书与 120 片瓶装面板（SPL v49；2026-03-24）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=3098a080-be86-4265-9818-7fc4beab77b7", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-05", "reviewedAt": "2026-09-05" }, { "id": "src_f1258d364bfd2ffa", "label": "FDA：LIALDA NDA 022000 审评资料，记录 2007-01-16 初始批准历史", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022000Orig1s005.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_regulatory_document", "documentKind": "regulatory_review", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-05", "reviewedAt": "2026-09-05" }, { "id": "src_21a6177cab38ae20", "label": "FDA Drugs@FDA：LIALDA NDA 022000 产品与监管记录入口", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=022000", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-05", "reviewedAt": "2026-09-05" } ], "applicationNumber": "NDA 022000", "approvalTimeline": [ { "date": "2007-01-16", "title": { "zh": "LIALDA 美国初始批准", "en": "Initial U.S. approval of LIALDA" }, "detail": { "zh": "FDA 审评资料记录 NDA 022000 于该日初始获批；与标签所示美沙拉秦 1987 年初始批准年份分开。", "en": "FDA review material records initial approval of NDA 022000 on this date; this is distinct from the label's 1987 initial U.S. approval year for mesalamine." }, "source": { "id": "src_f1258d364bfd2ffa", "label": "FDA：LIALDA NDA 022000 审评资料，记录 2007-01-16 初始批准历史", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022000Orig1s005.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_regulatory_document", "documentKind": "regulatory_review", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-05", "reviewedAt": "2026-09-05" } }, { "date": "2026-03-24", "title": { "zh": "当前 DailyMed 标签版本生效", "en": "Current DailyMed label effective" }, "detail": { "zh": "SPL v49 列出 1.2 g 延迟释放片、精确 NDC 和 120 片瓶装。", "en": "SPL v49 lists the 1.2 g delayed-release tablet, exact NDC and 120-tablet bottle." }, "source": { "id": "src_2cd8e9973cb2ee63", "label": "DailyMed（NLM）：LIALDA 美沙拉秦 1.2 g 延迟释放片当前美国品牌标签、说明书与 120 片瓶装面板（SPL v49；2026-03-24）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=3098a080-be86-4265-9818-7fc4beab77b7", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-05", "reviewedAt": "2026-09-05" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "当前公开品牌标签", "en": "Current public brand label" }, "detail": { "zh": "展示一个准确 120 片瓶装；不证明实时供应。", "en": "One exact 120-tablet bottle is displayed; not proof of live supply." } }, { "market": { "zh": "中国大陆及其他市场", "en": "Mainland China and other markets" }, "status": { "zh": "当地批准、商品名、参比、包装和供应尚未逐市场确认", "en": "Local approval, brand, reference, pack and supply not yet established market by market" }, "detail": { "zh": "不从美国 NDA、NDC 或包装推定其他市场状态。", "en": "No other-market status is inferred from the U.S. NDA, NDC or pack." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "1.2 g 是每次吃一片吗？", "en": "Does 1.2 g mean one tablet each time?" }, "answer": { "zh": "不是。1.2 g 只说明每片含量；个人片数、频次与疗程必须以准确处方和专业复核为准。", "en": "No. 1.2 g is only the amount per tablet; tablet count, frequency and course require the exact prescription and professional review." } }, { "question": { "zh": "其他美沙拉秦也是同成分，能按总毫克直接换吗？", "en": "Can another mesalamine product be switched by total milligrams?" }, "answer": { "zh": "不能自行换。释放设计、剂型、规格和标签可能不同，应带两盒实物或官方说明书由医生或药师逐项核对。", "en": "Do not self-switch. Release design, form, strength and labelling may differ; have a doctor or pharmacist compare both actual packs or official labels." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "dose-unit-literacy", "same-class-is-not-same-medicine", "interactions-are-not-a-home-scheduling-problem" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/lialda-mesalamine/", "en": "https://origindrug.com/en/drugs/lialda-mesalamine/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "dilantin-phenytoin", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-09-05", "status": "published_traceable_archive" }, "names": { "brand": "DILANTIN", "generic": "苯妥英钠缓释胶囊", "aliases": [ "Dilantin", "phenytoin", "phenytoin sodium extended capsules", "苯妥英", "苯妥英钠", "苯妥英钠缓释胶囊", "NDC 58151-118-01", "NDC 58151-110-01", "084349", "DILANTIN", "phenytoin sodium", "extended phenytoin sodium capsules", "58151-118-01", "58151-110-01" ], "marketBrandNames": [ { "name": "DILANTIN", "market": { "zh": "美国", "en": "United States" }, "evidenceStatus": "current_regulatory_record", "note": { "zh": "当前品牌标签；不证明实时库存、价格或个人适用。", "en": "Current brand label; not proof of live stock, price or individual suitability." }, "source": { "id": "src_4f74986d28d6a759", "label": "DailyMed（NLM）：DILANTIN 苯妥英钠缓释胶囊当前美国品牌标签（30 mg、100 mg；2023-08 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=86dd27d1-9cee-48ae-b55d-e2d2f7dbc593", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-05", "reviewedAt": "2026-09-05" } } ], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "神经与认知", "sourceArchiveMarket": "本页只建立美国 DILANTIN 苯妥英钠缓释胶囊当前品牌标签档案：30 mg 与 100 mg 每粒含量及两个 100 粒瓶装。该记录不外推中国大陆或其他市场的批准、商品名、参比身份、供应、价格、购买资格或个人适用性。", "dosageFormClass": "本档案只对应 DILANTIN 缓释苯妥英钠胶囊。口服混悬液、咀嚼片、速释胶囊、磷苯妥英注射剂以及其他厂牌不是同一个准确产品；剂型或品牌变化需要专业监测，不能只按共同成分或总毫克数自行替换。", "dosageFormClassCode": "oral_modified_release", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "1953（标签所示苯妥英美国初始批准年份）", "archiveSponsorText": "Viatris Specialty LLC" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [ "DILANTIN", "DILANTIN extended phenytoin sodium capsules", "苯妥英钠缓释胶囊" ], "excludedProductCues": [ "DILANTIN-125", "DILANTIN INFATABS", "phenytoin oral suspension", "phenytoin prompt capsules", "fosphenytoin", "CEREBYX", "generic phenytoin" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-dilantin-phenytoin-extended-capsule-30mg-100-bottle-ndc-5815111801", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国品牌标签（2023-08 修订）", "en": "Current U.S. DailyMed brand label (revised August 2023)" }, "dosageForm": { "zh": "DILANTIN 苯妥英钠缓释胶囊", "en": "DILANTIN extended phenytoin sodium capsule" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 58151-118-01", "pouchCode": null, "applicationNumber": "ANDA 084349（legacy RLD record）", "presentationRole": null, "primaryStrengthBasisCode": "per_capsule", "primaryDisplay": { "zh": "每粒含苯妥英钠 30 mg；100 粒瓶装", "en": "Phenytoin sodium 30 mg per capsule; 100-capsule bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=image-02.jpg&setid=86dd27d1-9cee-48ae-b55d-e2d2f7dbc593&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "苯妥英钠", "en": "phenytoin sodium" }, "value": 30, "unit": "mg", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒标签标示量；不是个人粒数、频次、疗程或换药换算值", "en": "labelled amount per capsule; not an individual's capsule count, frequency, course or switching conversion" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-05", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "current_regulatory_listing_not_live_stock", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "physicalClues": { "color": { "zh": "白色不透明囊体、淡粉色囊帽", "en": "white opaque body with pale-pink cap" }, "shape": { "zh": "4号硬胶囊", "en": "size 4 hard capsule" }, "imprint": "VLE / DILANTIN 30 mg", "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_4f74986d28d6a759", "label": "DailyMed（NLM）：DILANTIN 苯妥英钠缓释胶囊当前美国品牌标签（30 mg、100 mg；2023-08 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=86dd27d1-9cee-48ae-b55d-e2d2f7dbc593", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-05", "reviewedAt": "2026-09-05" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-dilantin-phenytoin-extended-capsule-100mg-100-bottle-ndc-5815111001", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国品牌标签（2023-08 修订）", "en": "Current U.S. DailyMed brand label (revised August 2023)" }, "dosageForm": { "zh": "DILANTIN 苯妥英钠缓释胶囊", "en": "DILANTIN extended phenytoin sodium capsule" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 58151-110-01", "pouchCode": null, "applicationNumber": "ANDA 084349（legacy RLD record）", "presentationRole": null, "primaryStrengthBasisCode": "per_capsule", "primaryDisplay": { "zh": "每粒含苯妥英钠 100 mg；100 粒瓶装", "en": "Phenytoin sodium 100 mg per capsule; 100-capsule bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=image-03.jpg&setid=86dd27d1-9cee-48ae-b55d-e2d2f7dbc593&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "苯妥英钠", "en": "phenytoin sodium" }, "value": 100, "unit": "mg", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒标签标示量；不是个人粒数、频次、疗程或换药换算值", "en": "labelled amount per capsule; not an individual's capsule count, frequency, course or switching conversion" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-05", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "current_regulatory_listing_not_live_stock", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "physicalClues": { "color": { "zh": "白色不透明囊体、中橙色囊帽", "en": "white opaque body with medium-orange cap" }, "shape": { "zh": "3号硬胶囊", "en": "size 3 hard capsule" }, "imprint": "VLE / DILANTIN / 100 mg", "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_4f74986d28d6a759", "label": "DailyMed（NLM）：DILANTIN 苯妥英钠缓释胶囊当前美国品牌标签（30 mg、100 mg；2023-08 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=86dd27d1-9cee-48ae-b55d-e2d2f7dbc593", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-05", "reviewedAt": "2026-09-05" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-dilantin-phenytoin-extended-capsule-100mg-100-bottle-ndc-5815111001", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=image-03.jpg&setid=86dd27d1-9cee-48ae-b55d-e2d2f7dbc593&type=img", "alt": "DILANTIN 100 mg、NDC 58151-110-01、100 粒瓶装的 DailyMed 官方包装面板", "archiveMarket": "美国", "labelVersion": "DailyMed；2023-08 修订", "presentation": "白色不透明囊体、中橙色囊帽，VLE / DILANTIN / 100 mg；每粒 100 mg，100 粒瓶装。", "notice": "只对应所引美国当前准确包装。外观、颜色和刻印仅用于辅助定位，不用于鉴定真伪、证明实时库存或生成个人剂量。", "source": { "id": "src_4f74986d28d6a759", "label": "DailyMed（NLM）：DILANTIN 苯妥英钠缓释胶囊当前美国品牌标签（30 mg、100 mg；2023-08 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=86dd27d1-9cee-48ae-b55d-e2d2f7dbc593", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-05", "reviewedAt": "2026-09-05" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "DILANTIN 说明书放大阅读：每粒含量、不能突然停药、血药浓度与多药核对", "en": "DILANTIN enlarged label: per-capsule amount, no abrupt withdrawal, levels and polypharmacy review" }, "summary": { "zh": "包装上的 30 mg 或 100 mg 是每粒含量，100 Capsules 是瓶内粒数。不能据此推导个人粒数、频次、疗程或换药换算。突然停用抗癫痫药可能诱发癫痫持续状态，应按专业安排调整。", "en": "The 30 mg or 100 mg figure is the amount per capsule and 100 Capsules is the bottle count. Pack numbers do not determine an individual's capsule count, frequency, course or switching conversion. Abrupt antiepileptic withdrawal may precipitate status epilepticus; changes require professional planning." }, "checks": [ { "zh": "不要突然停用、漏服后自行加倍、轮换不同厂牌或把缓释胶囊换成其他剂型；品牌或剂型变化可能改变吸收，需要按专业安排监测苯妥英浓度和临床反应。", "en": "Do not abruptly stop, double after a missed dose, rotate brands or replace extended capsules with another form. Brand or dosage-form changes may alter absorption and require professionally planned phenytoin-level and clinical monitoring." }, { "zh": "眼震、走路不稳、说话含糊、嗜睡、意识变化等可能提示神经系统毒性；不要用网页自行调量，应及时联系医疗专业人员。", "en": "Nystagmus, unsteady walking, slurred speech, drowsiness or mental-status change may signal neurologic toxicity. Do not self-adjust from a webpage; contact a healthcare professional promptly." }, { "zh": "严重皮疹、水疱、口腔黏膜损害、面唇舌喉肿胀、发热伴皮疹或淋巴结肿大，可能涉及严重皮肤反应、DRESS 或血管性水肿，需要紧急医疗评估。", "en": "Severe rash, blistering, mucosal injury, swelling of the face/lips/tongue/throat, or fever with rash or lymph-node enlargement may involve severe skin reactions, DRESS or angioedema and needs urgent medical assessment." }, { "zh": "苯妥英相互作用很多；处方药、非处方药、中草药、补充剂、酒精使用情况和营养支持都应一次性交给医生或药师核对，不能只靠错开时间。", "en": "Phenytoin has many interactions. Prescriptions, OTC medicines, herbs, supplements, alcohol use and nutrition support should be reviewed together by a doctor or pharmacist; simply spacing doses is insufficient." }, { "zh": "老人清除率可能降低；肝肾功能异常或低白蛋白时，总浓度可能误导，需要专业人员判断是否监测游离苯妥英。不要按年龄自行减粒。", "en": "Clearance may decrease in older adults. With renal/hepatic impairment or hypoalbuminemia, total concentration can mislead and a professional may consider unbound phenytoin. Do not self-reduce by age." }, { "zh": "CYP2C9 等遗传因素只是严重皮肤反应和代谢风险评估的一部分；说明书并不支持人人做全基因筛查，也不能凭网页基因结果自行决定剂量。", "en": "Genetic factors such as CYP2C9 are only part of severe-skin-reaction and metabolism assessment. The label does not support whole-genome screening for everyone, and webpage genetic results must not determine self-dosing." } ], "source": { "id": "src_4f74986d28d6a759", "label": "DailyMed（NLM）：DILANTIN 苯妥英钠缓释胶囊当前美国品牌标签（30 mg、100 mg；2023-08 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=86dd27d1-9cee-48ae-b55d-e2d2f7dbc593", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-05", "reviewedAt": "2026-09-05" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "作用与浓度阅读：稳定钠通道不等于可以自行试量", "en": "Mechanism and concentration: sodium-channel stabilization does not justify self-titration" }, "summary": { "zh": "苯妥英通过影响电压依赖性钠通道、限制神经元重复放电而发挥抗癫痫作用。其代谢可在治疗范围内逐渐饱和，因此剂量与血药浓度不是简单线性关系；包装含量、体重或一次浓度都不能单独生成个人方案。", "en": "Phenytoin limits repetitive neuronal firing through effects on voltage-dependent sodium channels. Metabolism can become saturated within the therapeutic range, so dose and blood concentration are not simply linear; pack strength, body weight or one level cannot independently generate a personal regimen." }, "checks": [ { "zh": "小幅剂量变化也可能造成不成比例的浓度变化；不要把 30 mg 与 100 mg 当成可随意拼接的积木。", "en": "A small dose change may cause a disproportionate concentration change; do not treat 30 mg and 100 mg strengths as freely interchangeable building blocks." }, { "zh": "开始、停用或调整相互作用药物后，苯妥英浓度和临床反应可能变化；应由专业人员确定复核时点。", "en": "Starting, stopping or changing an interacting medicine can alter phenytoin levels and response; a professional should set review timing." }, { "zh": "控制发作与避免毒性需要结合处方、发作记录、症状、实验室结果和具体制剂；机制科普不能替代复诊。", "en": "Balancing seizure control and toxicity requires the prescription, seizure record, symptoms, laboratory results and exact formulation; mechanism education cannot replace follow-up." } ], "source": { "id": "src_4f74986d28d6a759", "label": "DailyMed（NLM）：DILANTIN 苯妥英钠缓释胶囊当前美国品牌标签（30 mg、100 mg；2023-08 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=86dd27d1-9cee-48ae-b55d-e2d2f7dbc593", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-05", "reviewedAt": "2026-09-05" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "DILANTIN", "generic": "苯妥英钠缓释胶囊", "dosageFormClass": "本档案只对应 DILANTIN 缓释苯妥英钠胶囊。口服混悬液、咀嚼片、速释胶囊、磷苯妥英注射剂以及其他厂牌不是同一个准确产品；剂型或品牌变化需要专业监测，不能只按共同成分或总毫克数自行替换。" }, "labelSource": { "id": "src_4f74986d28d6a759", "label": "DailyMed（NLM）：DILANTIN 苯妥英钠缓释胶囊当前美国品牌标签（30 mg、100 mg；2023-08 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=86dd27d1-9cee-48ae-b55d-e2d2f7dbc593", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-05", "reviewedAt": "2026-09-05" }, "productRoutes": [ { "source": { "id": "src_4f74986d28d6a759", "label": "DailyMed（NLM）：DILANTIN 苯妥英钠缓释胶囊当前美国品牌标签（30 mg、100 mg；2023-08 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=86dd27d1-9cee-48ae-b55d-e2d2f7dbc593", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-05", "reviewedAt": "2026-09-05" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-09-05", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-09-05", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "DILANTIN 是苯妥英钠缓释胶囊的美国品牌档案。30 mg 或 100 mg 是每粒含量，100 Capsules 是整瓶粒数，都不是个人应该吃几粒。苯妥英代谢具有饱和、非线性特征，小幅剂量或相互作用变化也可能带来明显血药浓度变化；不要自行加减、突然停用、换厂牌或换剂型。老人、多药合用者，以及肝肾功能或白蛋白异常者尤其需要把实际药盒、完整药单和监测结果一起交给医生或药师核对。", "history": "DILANTIN 标签标注苯妥英于 1953 年在美国初始获批。FDA 2007 年审评资料确认 100 mg 缓释胶囊的参比制剂历史；当前 DailyMed 品牌标签于 2023 年 8 月修订，列出 30 mg 和 100 mg 缓释胶囊及精确包装。", "sourceDocuments": [ { "id": "src_4f74986d28d6a759", "label": "DailyMed（NLM）：DILANTIN 苯妥英钠缓释胶囊当前美国品牌标签（30 mg、100 mg；2023-08 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=86dd27d1-9cee-48ae-b55d-e2d2f7dbc593", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-05", "reviewedAt": "2026-09-05" }, { "id": "src_fb1b5582e14ba71e", "label": "FDA：DILANTIN 2021 年批准标签，记录苯妥英美国初始批准年份 1953", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/084349s087lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_regulatory_document", "documentKind": "approved_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-05", "reviewedAt": "2026-09-05" }, { "id": "src_2abd274b26c87f1f", "label": "FDA：DILANTIN 100 mg 缓释胶囊参比制剂（RLD）生物等效性审评资料（2007）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/084349Orig1s045BIOEQ_REV.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_regulatory_document", "documentKind": "regulatory_review", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-05", "reviewedAt": "2026-09-05" } ], "applicationNumber": "ANDA 084349（legacy RLD record）", "approvalTimeline": [ { "date": "1953", "title": { "zh": "苯妥英美国初始批准年份", "en": "Initial U.S. approval year for phenytoin" }, "detail": { "zh": "FDA 批准标签列出 Initial U.S. Approval: 1953。", "en": "The FDA-approved label states Initial U.S. Approval: 1953." }, "source": { "id": "src_fb1b5582e14ba71e", "label": "FDA：DILANTIN 2021 年批准标签，记录苯妥英美国初始批准年份 1953", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/084349s087lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_regulatory_document", "documentKind": "approved_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-05", "reviewedAt": "2026-09-05" } }, { "date": "2007-05-17", "title": { "zh": "FDA 参比制剂审评记录", "en": "FDA reference-listed-drug review" }, "detail": { "zh": "FDA 审评资料将 DILANTIN 100 mg 缓释胶囊列为 Orange Book RLD，并保留历史申请编号口径。", "en": "FDA review material identifies DILANTIN 100 mg extended capsules as the Orange Book RLD and preserves the legacy application-number terminology." }, "source": { "id": "src_2abd274b26c87f1f", "label": "FDA：DILANTIN 100 mg 缓释胶囊参比制剂（RLD）生物等效性审评资料（2007）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/084349Orig1s045BIOEQ_REV.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_regulatory_document", "documentKind": "regulatory_review", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-05", "reviewedAt": "2026-09-05" } }, { "date": "2023-08", "title": { "zh": "当前 DailyMed 标签修订", "en": "Current DailyMed label revision" }, "detail": { "zh": "标签列出 30 mg 与 100 mg 缓释胶囊、精确 NDC 和包装面板。", "en": "The label lists 30 mg and 100 mg extended capsules, exact NDCs and package panels." }, "source": { "id": "src_4f74986d28d6a759", "label": "DailyMed（NLM）：DILANTIN 苯妥英钠缓释胶囊当前美国品牌标签（30 mg、100 mg；2023-08 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=86dd27d1-9cee-48ae-b55d-e2d2f7dbc593", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-05", "reviewedAt": "2026-09-05" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "当前公开品牌标签", "en": "Current public brand label" }, "detail": { "zh": "展示两个准确 100 粒瓶装；不证明实时供应。", "en": "Two exact 100-capsule bottles are displayed; not proof of live supply." } }, { "market": { "zh": "中国大陆及其他市场", "en": "Mainland China and other markets" }, "status": { "zh": "当地批准、商品名、参比、包装和供应尚未逐市场确认", "en": "Local approval, brand, reference, pack and supply not yet established market by market" }, "detail": { "zh": "不从美国标签或历史 RLD 记录推定其他市场状态。", "en": "No other-market status is inferred from the U.S. label or legacy RLD record." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "100 mg 是每次吃一粒吗？", "en": "Does 100 mg mean one capsule each time?" }, "answer": { "zh": "不是。100 mg 只说明每粒含量；个人粒数、频次和疗程必须以准确处方、具体剂型和专业监测为准。", "en": "No. 100 mg is only the amount per capsule; capsule count, frequency and course require the exact prescription, formulation and professional monitoring." } }, { "question": { "zh": "同是苯妥英，能直接换厂牌或剂型吗？", "en": "Can phenytoin brands or dosage forms be switched directly?" }, "answer": { "zh": "不能自行换。吸收和释放可能不同，说明书要求品牌或剂型变化时谨慎并监测血药浓度；请带两盒实物或官方说明书复核。", "en": "Do not self-switch. Absorption and release may differ; the label calls for caution and level monitoring with brand or dosage-form changes. Bring both packs or official labels for review." } }, { "question": { "zh": "老人是不是减半吃就更安全？", "en": "Is half the dose automatically safer for an older adult?" }, "answer": { "zh": "不是。老人清除率可能降低，但具体调整需要结合制剂、处方、发作情况、相互作用、肝肾功能、白蛋白和浓度监测，不能自行掰分或减粒。", "en": "No. Clearance may decrease with age, but changes require formulation, prescription, seizure status, interactions, liver/kidney function, albumin and level monitoring; do not split or reduce capsules yourself." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "dose-unit-literacy", "same-class-is-not-same-medicine", "interactions-are-not-a-home-scheduling-problem" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/dilantin-phenytoin/", "en": "https://origindrug.com/en/drugs/dilantin-phenytoin/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "hygroton-chlorthalidone", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-09-02", "status": "published_traceable_archive" }, "names": { "brand": "HYGROTON / chlorthalidone", "generic": "氯噻酮普通片", "aliases": [ "HYGROTON", "Hygroton", "chlorthalidone", "chlortalidone", "氯噻酮", "氯噻酮片", "chlorthalidone tablets", "NDA 012283", "ANDA 086831", "0378-0222-01", "0378-0222-10", "0378-0213-01", "0378-0213-10", "M35", "M 75" ], "marketBrandNames": [ { "name": "HYGROTON", "market": { "zh": "美国", "en": "United States" }, "evidenceStatus": "historical_regulatory_record", "note": { "zh": "NDA 012283 历史原研/RLD；已停市，FDA 审评说明停市并非安全性或有效性原因。本页不展示其原品牌包装。", "en": "Historical originator/RLD under NDA 012283; discontinued, with FDA review stating that withdrawal was not for safety or efficacy reasons. This page does not display an original-brand pack." }, "source": { "id": "src_c1df715dc8b77961", "label": "FDA：HYGROTON（chlorthalidone）NDA 012283 原研/RLD 历史与停市原因边界（NDA 218647 临床药理审评）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2026/218647Orig1s000ClinPharmR.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_regulatory_document", "documentKind": "regulatory_review", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" } }, { "name": "chlorthalidone", "market": { "zh": "美国", "en": "United States" }, "evidenceStatus": "current_regulatory_record", "note": { "zh": "Mylan ANDA 086831 当前通用药标签；25/50 mg 的 100 片与 1000 片瓶装。监管标签不等于实时库存。", "en": "Current Mylan generic label under ANDA 086831; 25/50 mg in 100- and 1000-tablet bottles. A regulatory label is not live stock." }, "source": { "id": "src_6cd5b91200615b7e", "label": "DailyMed（NLM）：氯噻酮 25／50 mg 当前美国通用药标签及两个 100 片瓶装面板（Mylan／Viatris，2026-04）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=15dd224a-87ad-48dc-80b1-e8382a452c4c", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" } } ], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "心血管", "sourceArchiveMarket": "FDA 审评文件将 HYGROTON（NDA 012283）列为氯噻酮历史原研/RLD，并说明其停市并非出于安全性或有效性原因。当前准确包装来自 Mylan ANDA 086831 通用药标签：25 mg 与 50 mg，每种均有 100 片和 1000 片瓶装；只有两个 100 片面板有本页展示的准确公开图片。历史品牌、当前通用药和其他市场供应不得混写。", "dosageFormClass": "氯噻酮普通口服片。HYGROTON 历史原研、Mylan 当前通用药、HEMICLOR 12.5 mg 及含氯噻酮复方是不同监管产品；共同成分不建立包装、强度、片数或替换结论。", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "1960（HYGROTON 美国初始批准年份）", "archiveSponsorText": "HYGROTON 历史原研/RLD；Mylan Pharmaceuticals Inc.／Viatris 为当前展示通用药标签方" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [ "HYGROTON", "chlorthalidone", "chlorthalidone tablets", "氯噻酮", "氯噻酮片" ], "excludedProductCues": [ "HEMICLOR", "chlorthalidone 12.5 mg", "HYGROTON RESERPINE", "hydrochlorothiazide", "氢氯噻嗪", "indapamide", "吲达帕胺" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-chlorthalidone-25mg-100-tablet-bottle-ndc-0378022201", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国通用药标签（2026-04-02 修订）", "en": "Current U.S. DailyMed generic label (revised 2 Apr 2026)" }, "dosageForm": { "zh": "氯噻酮普通口服片", "en": "chlorthalidone immediate-release oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 0378-0222-01", "pouchCode": null, "applicationNumber": "ANDA 086831", "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片氯噻酮 25 mg；100 片瓶装", "en": "25 mg chlorthalidone per tablet; 100-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=image-02.jpg&setid=15dd224a-87ad-48dc-80b1-e8382a452c4c&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "氯噻酮", "en": "chlorthalidone" }, "value": 25, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、服用频次，也不是与氢氯噻嗪、吲达帕胺或其他利尿药的换算值", "en": "labelled amount per tablet; not an individual's tablet count or frequency, or a conversion to hydrochlorothiazide, indapamide or another diuretic" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-02", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "current_regulatory_listing_not_live_stock", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "浅黄色", "en": "light yellow" }, "shape": { "zh": "圆形普通片", "en": "round immediate-release tablet" }, "imprint": "M35", "scoreStatus": "unscored_no_split_permission_inferred", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_6cd5b91200615b7e", "label": "DailyMed（NLM）：氯噻酮 25／50 mg 当前美国通用药标签及两个 100 片瓶装面板（Mylan／Viatris，2026-04）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=15dd224a-87ad-48dc-80b1-e8382a452c4c", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-chlorthalidone-25mg-1000-tablet-bottle-ndc-0378022210", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国通用药标签（2026-04-02 修订）", "en": "Current U.S. DailyMed generic label (revised 2 Apr 2026)" }, "dosageForm": { "zh": "氯噻酮普通口服片", "en": "chlorthalidone immediate-release oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 0378-0222-10", "pouchCode": null, "applicationNumber": "ANDA 086831", "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片氯噻酮 25 mg；1000 片瓶装", "en": "25 mg chlorthalidone per tablet; 1000-tablet bottle" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "氯噻酮", "en": "chlorthalidone" }, "value": 25, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、服用频次，也不是与氢氯噻嗪、吲达帕胺或其他利尿药的换算值", "en": "labelled amount per tablet; not an individual's tablet count or frequency, or a conversion to hydrochlorothiazide, indapamide or another diuretic" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 1000, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-02", "currentLabelDisplayed": false, "ndcDirectoryListed": true, "marketAvailability": "current_regulatory_listing_not_live_stock", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 1000, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "浅黄色", "en": "light yellow" }, "shape": { "zh": "圆形普通片", "en": "round immediate-release tablet" }, "imprint": "M35", "scoreStatus": "unscored_no_split_permission_inferred", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_6cd5b91200615b7e", "label": "DailyMed（NLM）：氯噻酮 25／50 mg 当前美国通用药标签及两个 100 片瓶装面板（Mylan／Viatris，2026-04）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=15dd224a-87ad-48dc-80b1-e8382a452c4c", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-chlorthalidone-50mg-100-tablet-bottle-ndc-0378021301", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国通用药标签（2026-04-02 修订）", "en": "Current U.S. DailyMed generic label (revised 2 Apr 2026)" }, "dosageForm": { "zh": "氯噻酮普通口服片", "en": "chlorthalidone immediate-release oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 0378-0213-01", "pouchCode": null, "applicationNumber": "ANDA 086831", "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片氯噻酮 50 mg；100 片瓶装", "en": "50 mg chlorthalidone per tablet; 100-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=image-03.jpg&setid=15dd224a-87ad-48dc-80b1-e8382a452c4c&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "氯噻酮", "en": "chlorthalidone" }, "value": 50, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、服用频次，也不是与氢氯噻嗪、吲达帕胺或其他利尿药的换算值", "en": "labelled amount per tablet; not an individual's tablet count or frequency, or a conversion to hydrochlorothiazide, indapamide or another diuretic" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-02", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "current_regulatory_listing_not_live_stock", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "浅绿色", "en": "light green" }, "shape": { "zh": "圆形普通片", "en": "round immediate-release tablet" }, "imprint": "M / 75", "scoreStatus": "scored_not_self_split_permission", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_6cd5b91200615b7e", "label": "DailyMed（NLM）：氯噻酮 25／50 mg 当前美国通用药标签及两个 100 片瓶装面板（Mylan／Viatris，2026-04）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=15dd224a-87ad-48dc-80b1-e8382a452c4c", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-chlorthalidone-50mg-1000-tablet-bottle-ndc-0378021310", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国通用药标签（2026-04-02 修订）", "en": "Current U.S. DailyMed generic label (revised 2 Apr 2026)" }, "dosageForm": { "zh": "氯噻酮普通口服片", "en": "chlorthalidone immediate-release oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 0378-0213-10", "pouchCode": null, "applicationNumber": "ANDA 086831", "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片氯噻酮 50 mg；1000 片瓶装", "en": "50 mg chlorthalidone per tablet; 1000-tablet bottle" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "氯噻酮", "en": "chlorthalidone" }, "value": 50, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、服用频次，也不是与氢氯噻嗪、吲达帕胺或其他利尿药的换算值", "en": "labelled amount per tablet; not an individual's tablet count or frequency, or a conversion to hydrochlorothiazide, indapamide or another diuretic" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 1000, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-02", "currentLabelDisplayed": false, "ndcDirectoryListed": true, "marketAvailability": "current_regulatory_listing_not_live_stock", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 1000, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "浅绿色", "en": "light green" }, "shape": { "zh": "圆形普通片", "en": "round immediate-release tablet" }, "imprint": "M / 75", "scoreStatus": "scored_not_self_split_permission", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_6cd5b91200615b7e", "label": "DailyMed（NLM）：氯噻酮 25／50 mg 当前美国通用药标签及两个 100 片瓶装面板（Mylan／Viatris，2026-04）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=15dd224a-87ad-48dc-80b1-e8382a452c4c", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-chlorthalidone-25mg-100-tablet-bottle-ndc-0378022201", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=image-02.jpg&setid=15dd224a-87ad-48dc-80b1-e8382a452c4c&type=img", "alt": "Mylan/Viatris 氯噻酮 25 mg、NDC 0378-0222-01、100 片瓶装的 DailyMed 官方通用药标签面板", "archiveMarket": "美国", "labelVersion": "DailyMed 当前美国通用药标签（2026-04）", "presentation": "25 mg：浅黄色圆片、M35、无刻痕；NDC 0378-0222-01，100 片瓶装。另有 50 mg 浅绿色 M/75 有刻痕、NDC 0378-0213-01 的准确 100 片面板。", "notice": "此图是 Mylan/Viatris 当前通用药包装标签，不是 HYGROTON 原品牌包装；只对应 NDC 0378-0222-01，不代表 50 mg、1000 片瓶装、HEMICLOR、复方或其他市场供应，也不用于鉴定真伪。", "source": { "id": "src_6cd5b91200615b7e", "label": "DailyMed（NLM）：氯噻酮 25／50 mg 当前美国通用药标签及两个 100 片瓶装面板（Mylan／Viatris，2026-04）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=15dd224a-87ad-48dc-80b1-e8382a452c4c", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "氯噻酮说明书放大阅读：分清历史 HYGROTON、当前通用药、每片 mg 与整瓶片数", "en": "Chlorthalidone enlarged label: separate historical HYGROTON, the current generic, per-tablet mg and bottle count" }, "summary": { "zh": "25 mg 与 50 mg 是每片氯噻酮含量；100/1000 Tablets 是整瓶片数。50 mg 药片有刻痕，但刻痕只属于准确产品外观，不能自动变成任何人的掰片、加减量或换药许可。", "en": "The 25 mg and 50 mg figures are chlorthalidone per tablet; 100/1000 Tablets are bottle counts. The 50 mg tablet is scored, but a score is an exact-product appearance feature—not automatic permission for anyone to split, change an amount or switch medicines." }, "checks": [ { "zh": "利尿会影响水分与电解质。口渴、口干、乏力、嗜睡、肌肉痛/痉挛、恶心、心跳异常、意识或步态变化，都应结合钠、钾、镁、肾功能和完整药单及时核对；严重症状或昏厥使用当地急救。", "en": "Diuresis can affect fluid and electrolytes. Thirst, dry mouth, weakness, somnolence, muscle pain/cramps, nausea, an abnormal heartbeat, or changes in awareness or gait require timely review with sodium, potassium, magnesium, kidney function and the complete medicine list. Use local emergency care for severe symptoms or fainting." }, { "zh": "老人、进食饮水减少、呕吐腹泻、发热或同时使用其他降压/利尿药时，更容易出现容量不足、站立性头晕、低血压和跌倒；不要据家庭血压或水肿自行停、加、减或隔天轮换。", "en": "Older age, reduced food or fluid intake, vomiting/diarrhoea, fever, or another blood-pressure/diuretic medicine can increase volume depletion, orthostatic dizziness, hypotension and falls. Do not self-stop, increase, reduce or alternate from home blood pressure or oedema alone." }, { "zh": "标签要求关注肾功能、肝病、尿酸/痛风、血糖与脂质变化。无尿是禁忌；严重肾病或肝病必须由负责治疗的专业人员评估，网页不从化验值生成方案。", "en": "The label calls for attention to kidney function, liver disease, uric acid/gout, glucose and lipid changes. Anuria is contraindicated; severe kidney or liver disease requires treating-professional assessment, and the site does not generate a plan from laboratory values." }, { "zh": "地高辛、锂、NSAID 止痛药、糖皮质激素、促皮质激素、其他利尿剂或降压药同处药单时，应优先核对电解质、肾功能、血压和药物浓度风险；不要自行错开或删除其中一盒。", "en": "Digoxin, lithium, an NSAID pain medicine, a corticosteroid, ACTH, another diuretic or blood-pressure medicine on the same list requires priority review of electrolytes, kidney function, blood pressure and concentration-related risk. Do not self-space or remove a pack." } ], "source": { "id": "src_6cd5b91200615b7e", "label": "DailyMed（NLM）：氯噻酮 25／50 mg 当前美国通用药标签及两个 100 片瓶装面板（Mylan／Viatris，2026-04）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=15dd224a-87ad-48dc-80b1-e8382a452c4c", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "氯噻酮怎样利尿降压：减少远端肾小管钠氯重吸收，不等于所有利尿药可以按 mg 换", "en": "How chlorthalidone causes diuresis and lowers pressure: reduced distal tubular sodium-chloride reabsorption does not make diuretics milligram-interchangeable" }, "summary": { "zh": "FDA 药理审评将氯噻酮描述为噻嗪样、磺酰胺衍生利尿药，其作用与拮抗远端肾小管钠氯同向转运有关。机制可解释水分、电解质与血压变化，但不能决定个人适用性、片数、时间、补钾或与其他药联用。", "en": "FDA pharmacology review describes chlorthalidone as a thiazide-like, sulfonamide-derived diuretic acting through antagonism of the distal tubular sodium-chloride cotransporter. The mechanism helps explain fluid, electrolyte and blood-pressure effects but cannot determine individual suitability, tablet count, timing, potassium use or combination therapy." }, "checks": [ { "zh": "氯噻酮、氢氯噻嗪、吲达帕胺、呋塞米、螺内酯和依普利酮不是同一种药；共同“利尿”用途不建立 mg 换算、轮换或叠加规则。", "en": "Chlorthalidone, hydrochlorothiazide, indapamide, furosemide, spironolactone and eplerenone are not one medicine. A shared diuretic purpose does not establish milligram conversion, alternation or combination." }, { "zh": "低钾不表示人人都应自行补钾；补钾、含钾代盐、ACEI/ARB/ARNI 或保钾利尿药可能改变另一方向的风险，必须结合化验和完整药单核对。", "en": "A low-potassium risk does not mean everyone should self-supplement. Potassium, potassium-containing salt substitutes, an ACE inhibitor/ARB/ARNI or a potassium-sparing diuretic can change risk in the opposite direction and requires laboratory and full-list review." }, { "zh": "排尿增多、体重或水肿变化不是个人服药方案。老人若出现明显乏力、意识变化、跌倒、心悸或无法进食饮水，应及时联系治疗团队，严重时使用急救。", "en": "More urination, weight change or oedema change is not an individual regimen. Marked weakness, altered awareness, a fall, palpitations or inability to eat or drink in an older adult needs prompt treating-team review and emergency care when severe." } ], "source": { "id": "src_b747da6d9fec0a51", "label": "FDA：氯噻酮药理、HYGROTON NDA 012283 与 Mylan ANDA 086831 桥接审评（NDA 218647）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2026/218647Orig1s000PharmR.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_regulatory_document", "documentKind": "regulatory_review", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "HYGROTON / chlorthalidone", "generic": "氯噻酮普通片", "dosageFormClass": "氯噻酮普通口服片。HYGROTON 历史原研、Mylan 当前通用药、HEMICLOR 12.5 mg 及含氯噻酮复方是不同监管产品；共同成分不建立包装、强度、片数或替换结论。" }, "labelSource": { "id": "src_6cd5b91200615b7e", "label": "DailyMed（NLM）：氯噻酮 25／50 mg 当前美国通用药标签及两个 100 片瓶装面板（Mylan／Viatris，2026-04）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=15dd224a-87ad-48dc-80b1-e8382a452c4c", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, "productRoutes": [ { "source": { "id": "src_6cd5b91200615b7e", "label": "DailyMed（NLM）：氯噻酮 25／50 mg 当前美国通用药标签及两个 100 片瓶装面板（Mylan／Viatris，2026-04）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=15dd224a-87ad-48dc-80b1-e8382a452c4c", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-09-02", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-09-02", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "HYGROTON 是氯噻酮的历史原研/RLD；本页可见的粉红/绿色标签面板是当前 Mylan/Viatris 通用药，不是原品牌包装。25/50 mg 是每片含量，100 或 1000 Tablets 是整瓶片数。老人和多药使用者应优先核对脱水、站立性头晕/跌倒、钠钾镁、肾功能、尿酸/痛风、血糖，以及地高辛、锂、NSAID、其他利尿剂与降压药；网页不生成个人片数或换药比例。", "history": "氯噻酮于 1960 年以 HYGROTON 在美国获批。FDA 2026 年 NDA 218647 审评回顾 HYGROTON NDA 012283，说明其后来停市并非出于安全性或有效性原因，并将 Mylan ANDA 086831 的 50 mg 产品列为参考标准。当前 DailyMed 通用药标签于 2026-04 修订，不能被描述为原品牌包装。", "sourceDocuments": [ { "id": "src_6cd5b91200615b7e", "label": "DailyMed（NLM）：氯噻酮 25／50 mg 当前美国通用药标签及两个 100 片瓶装面板（Mylan／Viatris，2026-04）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=15dd224a-87ad-48dc-80b1-e8382a452c4c", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, { "id": "src_c1df715dc8b77961", "label": "FDA：HYGROTON（chlorthalidone）NDA 012283 原研/RLD 历史与停市原因边界（NDA 218647 临床药理审评）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2026/218647Orig1s000ClinPharmR.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_regulatory_document", "documentKind": "regulatory_review", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, { "id": "src_b747da6d9fec0a51", "label": "FDA：氯噻酮药理、HYGROTON NDA 012283 与 Mylan ANDA 086831 桥接审评（NDA 218647）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2026/218647Orig1s000PharmR.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_regulatory_document", "documentKind": "regulatory_review", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" } ], "applicationNumber": "HYGROTON NDA 012283（历史原研/RLD）；Mylan chlorthalidone ANDA 086831（当前通用药标签）", "approvalTimeline": [ { "date": "1960", "title": { "zh": "HYGROTON 在美国初始批准", "en": "Initial U.S. approval of HYGROTON" }, "detail": { "zh": "FDA 审评文件记载氯噻酮于 1960 年初始获批，并把 HYGROTON NDA 012283 列为历史原研/RLD。", "en": "FDA review records chlorthalidone's initial approval in 1960 and identifies HYGROTON NDA 012283 as the historical originator/RLD." }, "source": { "id": "src_c1df715dc8b77961", "label": "FDA：HYGROTON（chlorthalidone）NDA 012283 原研/RLD 历史与停市原因边界（NDA 218647 临床药理审评）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2026/218647Orig1s000ClinPharmR.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_regulatory_document", "documentKind": "regulatory_review", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" } }, { "date": "2024-05-03", "title": { "zh": "FDA 审评明确历史原研停市与参考标准边界", "en": "FDA review clarified the discontinued originator and reference-standard boundary" }, "detail": { "zh": "审评说明 HYGROTON 已停市且并非安全性或有效性原因，并把 Mylan ANDA 086831 的 50 mg 氯噻酮列为参考标准。", "en": "The review states that HYGROTON was discontinued for reasons other than safety or efficacy and identifies Mylan chlorthalidone 50 mg under ANDA 086831 as the reference standard." }, "source": { "id": "src_c1df715dc8b77961", "label": "FDA：HYGROTON（chlorthalidone）NDA 012283 原研/RLD 历史与停市原因边界（NDA 218647 临床药理审评）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2026/218647Orig1s000ClinPharmR.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_regulatory_document", "documentKind": "regulatory_review", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" } }, { "date": "2026-04-02", "title": { "zh": "当前 Mylan 通用药标签修订", "en": "Current Mylan generic label revision" }, "detail": { "zh": "当前 25/50 mg、100/1000 片瓶装文字及两个 100 片包装面板可公开阅读。", "en": "Current 25/50 mg, 100/1000-tablet bottle text and two 100-tablet package panels are publicly readable." }, "source": { "id": "src_6cd5b91200615b7e", "label": "DailyMed（NLM）：氯噻酮 25／50 mg 当前美国通用药标签及两个 100 片瓶装面板（Mylan／Viatris，2026-04）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=15dd224a-87ad-48dc-80b1-e8382a452c4c", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" } } ], "marketStatus": [ { "market": { "zh": "美国 HYGROTON", "en": "United States — HYGROTON" }, "status": { "zh": "历史原研/RLD，已停市", "en": "Historical originator/RLD; discontinued" }, "detail": { "zh": "NDA 012283；FDA 审评说明停市并非安全性或有效性原因。", "en": "NDA 012283; FDA review states that discontinuation was not for safety or efficacy reasons." } }, { "market": { "zh": "美国 Mylan 通用药", "en": "United States — Mylan generic" }, "status": { "zh": "当前公开通用药标签", "en": "Current public generic label" }, "detail": { "zh": "ANDA 086831；25/50 mg，100/1000 片瓶装。", "en": "ANDA 086831; 25/50 mg in 100- and 1000-tablet bottles." } }, { "market": { "zh": "美国以外市场", "en": "Markets outside the United States" }, "status": { "zh": "本档案未确认当地品牌、规格、包装或供应", "en": "Local brand, strength, pack and supply are not established" }, "detail": { "zh": "必须按当地药监记录、现行说明书和手中药盒逐项核对。", "en": "Check the local regulator, current label and pack in hand item by item." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "照片里的是 HYGROTON 原研药盒吗？", "en": "Is the pictured pack the original HYGROTON pack?" }, "answer": { "zh": "不是。照片是 Mylan/Viatris 当前通用药 25 mg 或 50 mg 的包装标签；HYGROTON 只作为历史原研/RLD 身份展示，本页没有把通用药图片冒充原品牌外观。", "en": "No. The images are current Mylan/Viatris generic 25 mg or 50 mg package labels. HYGROTON is shown only as the historical originator/RLD identity; the page does not present a generic image as original-brand appearance." } }, { "question": { "zh": "50 mg 有刻痕，是不是能掰半当 25 mg？", "en": "The 50 mg tablet is scored. Can it be halved to make 25 mg?" }, "answer": { "zh": "不能由刻痕或算术自行决定。25 mg 与 50 mg 是不同准确产品；分片还涉及处方、产品标签、均一性、个人情况和药师确认。网页只记录刻痕，不生成掰片许可。", "en": "Not from a score or arithmetic alone. The 25 mg and 50 mg are distinct exact products, and splitting depends on the prescription, product label, uniformity, individual context and pharmacist review. The site records the score but does not issue splitting permission." } }, { "question": { "zh": "氯噻酮和氢氯噻嗪、呋塞米可以换着吃或一起吃吗？", "en": "Can chlorthalidone, hydrochlorothiazide or furosemide be alternated or combined?" }, "answer": { "zh": "网页不能这样决定。它们不是同一种药，作用强度、时程、适应证和电解质/肾功能风险不同；可能存在专业人员安排的联用，也可能造成重复或伤害，必须用准确药盒、化验、血压和完整药单核对。", "en": "The site cannot make that decision. They are different medicines with different potency, duration, indications and electrolyte/kidney risks. Professional combination may exist, but duplication or harm is also possible; exact packs, laboratory results, blood pressure and the complete list require review." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "dose-unit-literacy", "same-class-is-not-same-medicine", "interactions-are-not-a-home-scheduling-problem" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/hygroton-chlorthalidone/", "en": "https://origindrug.com/en/drugs/hygroton-chlorthalidone/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "lozol-indapamide", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-09-04", "status": "published_traceable_archive" }, "names": { "brand": "LOZOL / indapamide", "generic": "吲达帕胺普通片", "aliases": [ "LOZOL", "Lozol", "indapamide", "indapamide tablets", "吲达帕胺", "吲达帕胺片", "NDA 018538", "ANDA 074299", "62559-510-01", "62559-511-01", "ANI 510", "ANI 511" ], "marketBrandNames": [ { "name": "LOZOL", "market": { "zh": "美国", "en": "United States" }, "evidenceStatus": "historical_regulatory_record", "note": { "zh": "NDA 018538 历史原研/RLD；1.25/2.5 mg 已停市，且不是因安全性或有效性撤回。本页不展示原品牌包装。", "en": "Historical originator/RLD under NDA 018538; 1.25/2.5 mg discontinued, not withdrawn for safety or effectiveness. No original-brand pack is displayed." }, "source": { "id": "src_b6d76767d72b9883", "label": "FDA Drugs@FDA：LOZOL NDA 018538 历史原研/RLD、初始批准与停市原因边界", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=018538", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_regulatory_document", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" } }, { "name": "indapamide", "market": { "zh": "美国", "en": "United States" }, "evidenceStatus": "current_regulatory_record", "note": { "zh": "ANI ANDA 074299 当前通用药标签；监管记录不等于实时库存。", "en": "Current ANI generic label under ANDA 074299; a regulatory listing is not live stock." }, "source": { "id": "src_75b816aca5469bf8", "label": "DailyMed（NLM）：ANI 吲达帕胺 1.25／2.5 mg 当前美国通用药标签及包装面板（2025-09 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=deb83f97-6c61-4a09-bed6-18dcf1183405", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" } } ], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "心血管", "sourceArchiveMarket": "FDA 将 LOZOL NDA 018538 记录为历史原研/RLD，1.25 mg 与 2.5 mg 均已停市，且不是因安全性或有效性原因撤回。当前准确包装来自 ANI ANDA 074299 通用药标签；历史品牌、当前通用药、缓释片和复方不得混写。", "dosageFormClass": "吲达帕胺普通口服片。LOZOL 历史品牌、ANI 当前普通片、各地缓释片及含吲达帕胺复方属于不同准确产品；共同成分不建立包装、释放方式、强度或替换结论。", "dosageFormClassCode": "oral_modified_release", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "1983-07-06", "archiveSponsorText": "LOZOL 历史原研/RLD；ANI Pharmaceuticals, Inc. 为当前展示通用药标签方" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [ "LOZOL", "indapamide", "indapamide tablets", "吲达帕胺", "吲达帕胺片" ], "excludedProductCues": [ "indapamide sustained release", "indapamide SR", "indapamide modified release", "吲达帕胺缓释片", "WIDAPLIK", "telmisartan amlodipine indapamide", "hydrochlorothiazide", "chlorthalidone", "furosemide" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-ani-indapamide-1-25mg-100-tablet-bottle-ndc-6255951001", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前 ANI 通用药标签（2025-09-12 更新）", "en": "Current ANI generic DailyMed label (updated 12 Sep 2025)" }, "dosageForm": { "zh": "吲达帕胺普通口服片", "en": "indapamide immediate-release oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 62559-510-01", "pouchCode": null, "applicationNumber": "ANDA 074299", "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片吲达帕胺 1.25 mg；100 片瓶装", "en": "1.25 mg indapamide per tablet; 100-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=Label-125.jpg&setid=deb83f97-6c61-4a09-bed6-18dcf1183405", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "吲达帕胺", "en": "indapamide" }, "value": 1.25, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、频次或与其他利尿药的换算值", "en": "labelled amount per tablet; not an individual's tablet count, frequency or conversion to another diuretic" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-04", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "current_regulatory_listing_not_live_stock", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "橙色", "en": "orange" }, "shape": { "zh": "圆形普通片", "en": "round immediate-release tablet" }, "imprint": "ANI 510", "scoreStatus": "unscored_no_split_permission_inferred", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_75b816aca5469bf8", "label": "DailyMed（NLM）：ANI 吲达帕胺 1.25／2.5 mg 当前美国通用药标签及包装面板（2025-09 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=deb83f97-6c61-4a09-bed6-18dcf1183405", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-ani-indapamide-2-5mg-100-tablet-bottle-ndc-6255951101", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前 ANI 通用药标签（2025-09-12 更新）", "en": "Current ANI generic DailyMed label (updated 12 Sep 2025)" }, "dosageForm": { "zh": "吲达帕胺普通口服片", "en": "indapamide immediate-release oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 62559-511-01", "pouchCode": null, "applicationNumber": "ANDA 074299", "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片吲达帕胺 2.5 mg；100 片瓶装", "en": "2.5 mg indapamide per tablet; 100-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=Label-25.jpg&setid=deb83f97-6c61-4a09-bed6-18dcf1183405", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "吲达帕胺", "en": "indapamide" }, "value": 2.5, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、频次或与其他利尿药的换算值", "en": "labelled amount per tablet; not an individual's tablet count, frequency or conversion to another diuretic" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-04", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "current_regulatory_listing_not_live_stock", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "白色", "en": "white" }, "shape": { "zh": "圆形普通片", "en": "round immediate-release tablet" }, "imprint": "ANI 511", "scoreStatus": "unscored_no_split_permission_inferred", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_75b816aca5469bf8", "label": "DailyMed（NLM）：ANI 吲达帕胺 1.25／2.5 mg 当前美国通用药标签及包装面板（2025-09 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=deb83f97-6c61-4a09-bed6-18dcf1183405", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-ani-indapamide-1-25mg-100-tablet-bottle-ndc-6255951001", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=Label-125.jpg&setid=deb83f97-6c61-4a09-bed6-18dcf1183405", "alt": "ANI 吲达帕胺 1.25 mg、NDC 62559-510-01、100 片瓶装的 DailyMed 官方通用药标签面板", "archiveMarket": "美国", "labelVersion": "DailyMed 2025-09", "presentation": "1.25 mg 橙色圆片、ANI 510、无刻痕；另有 2.5 mg 白色圆片 ANI 511。", "notice": "这是 ANI 当前通用药标签，不是 LOZOL 原品牌包装；不代表缓释片、复方或其他市场供应，也不用于鉴定真伪。", "source": { "id": "src_75b816aca5469bf8", "label": "DailyMed（NLM）：ANI 吲达帕胺 1.25／2.5 mg 当前美国通用药标签及包装面板（2025-09 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=deb83f97-6c61-4a09-bed6-18dcf1183405", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "吲达帕胺说明书放大阅读：分清历史 LOZOL、当前通用药、普通片与缓释片", "en": "Indapamide enlarged label: separate historical LOZOL, the current generic, immediate and modified release" }, "summary": { "zh": "1.25 mg 与 2.5 mg 是每片含量；100 Tablets 是整瓶片数。当前 ANI 两种片剂均无刻痕，网页不从算术生成掰片、加减量或替换许可。", "en": "The 1.25 mg and 2.5 mg figures are per-tablet amounts; 100 Tablets is the bottle count. Both current ANI tablets are unscored, and arithmetic does not create permission to split, change an amount or substitute." }, "checks": [ { "zh": "标签提示严重低钠可伴低钾，报告主要见于老年女性。乏力、嗜睡、意识或步态变化、肌肉痉挛、心悸、晕厥应及时核对钠、钾、肾功能和完整药单；严重时使用当地急救。", "en": "The label warns that severe hyponatraemia may occur with hypokalaemia, reported primarily in older women. Weakness, somnolence, altered awareness or gait, cramps, palpitations or fainting need prompt sodium, potassium, kidney and full-list review; use local emergency care when severe." }, { "zh": "老人、进食饮水减少、呕吐腹泻或同时使用其他降压/利尿药时，更易出现脱水、站立性低血压和跌倒；不要据水肿、体重或家庭血压自行加减、停用或隔日轮换。", "en": "Older age, reduced intake, vomiting/diarrhoea or another antihypertensive/diuretic can increase dehydration, orthostatic hypotension and falls. Do not self-change, stop or alternate from oedema, weight or home pressure alone." }, { "zh": "锂、地高辛/其他强心苷、糖皮质激素或 ACTH、其他利尿剂同处药单时，应优先核对药物浓度、心律、电解质、肾功能和重复用药；不要自行错开或删除其中一盒。", "en": "Lithium, digoxin/another cardiac glycoside, a corticosteroid or ACTH, or another diuretic requires priority review of concentrations, rhythm, electrolytes, kidney function and duplication. Do not self-space or remove a pack." }, { "zh": "突发视力下降、眼痛或眼红可能涉及脉络膜积液或急性闭角型青光眼，应立即就医；网页不能用照片排除眼科急症。", "en": "Sudden reduced vision, eye pain or redness may involve choroidal effusion or acute angle-closure glaucoma and needs immediate care; a photo cannot exclude an eye emergency." } ], "source": { "id": "src_75b816aca5469bf8", "label": "DailyMed（NLM）：ANI 吲达帕胺 1.25／2.5 mg 当前美国通用药标签及包装面板（2025-09 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=deb83f97-6c61-4a09-bed6-18dcf1183405", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "吲达帕胺怎样利尿降压：作用机制不等于所有利尿药按 mg 互换", "en": "How indapamide causes diuresis and lowers pressure: mechanism does not make diuretics milligram-interchangeable" }, "summary": { "zh": "吲达帕胺属于磺酰胺类利尿降压药，影响肾小管电解质处理。机制可解释水分、电解质与血压变化，但不能决定个人片数、补钾、服用时间或联用方案。", "en": "Indapamide is a sulfonamide-derived diuretic antihypertensive affecting tubular electrolyte handling. Mechanism helps explain fluid, electrolyte and pressure changes but cannot determine tablet count, potassium use, timing or combinations." }, "checks": [ { "zh": "吲达帕胺、氯噻酮、氢氯噻嗪、呋塞米、螺内酯和依普利酮不是同一种药；共同用途不建立 mg 换算、轮换或叠加规则。", "en": "Indapamide, chlorthalidone, hydrochlorothiazide, furosemide, spironolactone and eplerenone are not one medicine. Shared purpose does not establish milligram conversion, alternation or combination." }, { "zh": "普通片与缓释/改良释放片的释放结构、规格和标签不同，不能仅按共同成分自行替换、压碎、掰分或拼片。", "en": "Immediate- and modified-release tablets differ in release structure, strength and label and cannot be self-substituted, crushed, divided or assembled from a shared ingredient." }, { "zh": "低钾风险不表示人人都应自行补钾；补钾、含钾代盐或保钾药物必须结合化验、肾功能和完整药单。", "en": "A low-potassium risk does not mean everyone should self-supplement; potassium, potassium salt substitutes or potassium-sparing medicines require laboratory, kidney and full-list review." } ], "source": { "id": "src_61e211239f8fb6af", "label": "FDA：LOZOL 1.25 mg 历史品牌说明书（2021-03）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/018538s030lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_regulatory_document", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "LOZOL / indapamide", "generic": "吲达帕胺普通片", "dosageFormClass": "吲达帕胺普通口服片。LOZOL 历史品牌、ANI 当前普通片、各地缓释片及含吲达帕胺复方属于不同准确产品；共同成分不建立包装、释放方式、强度或替换结论。" }, "labelSource": { "id": "src_75b816aca5469bf8", "label": "DailyMed（NLM）：ANI 吲达帕胺 1.25／2.5 mg 当前美国通用药标签及包装面板（2025-09 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=deb83f97-6c61-4a09-bed6-18dcf1183405", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" }, "productRoutes": [ { "source": { "id": "src_75b816aca5469bf8", "label": "DailyMed（NLM）：ANI 吲达帕胺 1.25／2.5 mg 当前美国通用药标签及包装面板（2025-09 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=deb83f97-6c61-4a09-bed6-18dcf1183405", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-09-04", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_b6d76767d72b9883", "label": "FDA Drugs@FDA：LOZOL NDA 018538 历史原研/RLD、初始批准与停市原因边界", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=018538", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_regulatory_document", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" }, "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-09-04", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_61e211239f8fb6af", "label": "FDA：LOZOL 1.25 mg 历史品牌说明书（2021-03）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/018538s030lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_regulatory_document", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" }, "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-09-04", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-09-04", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "LOZOL 是吲达帕胺的美国历史原研/RLD；本页图片是当前 ANI 通用药，不是 LOZOL 原品牌包装。1.25/2.5 mg 是每片含量，100 Tablets 是整瓶片数。老人，特别是老年女性，应优先核对低钠合并低钾、脱水、头晕和跌倒；锂、地高辛/强心苷、激素、其他利尿剂或降压药同处药单时需专业核对。", "history": "LOZOL NDA 018538 于 1983-07-06 作为新分子实体获批。FDA 记录两个历史规格已停市但不是因安全性或有效性原因。2021 年品牌标签更新加入脉络膜积液及急性闭角型青光眼相关警示；2025 年更新的 ANI DailyMed 标签用于展示当前通用药准确包装。", "sourceDocuments": [ { "id": "src_75b816aca5469bf8", "label": "DailyMed（NLM）：ANI 吲达帕胺 1.25／2.5 mg 当前美国通用药标签及包装面板（2025-09 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=deb83f97-6c61-4a09-bed6-18dcf1183405", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" }, { "id": "src_b6d76767d72b9883", "label": "FDA Drugs@FDA：LOZOL NDA 018538 历史原研/RLD、初始批准与停市原因边界", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=018538", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_regulatory_document", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" }, { "id": "src_61e211239f8fb6af", "label": "FDA：LOZOL 1.25 mg 历史品牌说明书（2021-03）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/018538s030lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_regulatory_document", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" }, { "id": "src_067ce3340f851c18", "label": "FDA：LOZOL 2021 年补充批准函（脉络膜积液/闭角型青光眼警示更新）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/018538Orig1s030ltr.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_regulatory_document", "documentKind": "regulatory_approval_letter", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" } ], "applicationNumber": "LOZOL NDA 018538（历史原研/RLD）；ANI indapamide ANDA 074299（当前通用药标签）", "approvalTimeline": [ { "date": "1983-07-06", "title": { "zh": "LOZOL 美国初始批准", "en": "Initial U.S. approval of LOZOL" }, "detail": { "zh": "NDA 018538，Type 1 新分子实体；历史原研/RLD。", "en": "NDA 018538, Type 1 new molecular entity; historical originator/RLD." }, "source": { "id": "src_b6d76767d72b9883", "label": "FDA Drugs@FDA：LOZOL NDA 018538 历史原研/RLD、初始批准与停市原因边界", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=018538", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_regulatory_document", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" } }, { "date": "2021-03-02", "title": { "zh": "FDA 批准眼部风险警示更新", "en": "FDA approved ocular-risk warning update" }, "detail": { "zh": "补充批准函加入脉络膜积液相关语言并更新急性闭角型青光眼警示。", "en": "The supplement approval added choroidal-effusion language and updated the acute angle-closure glaucoma warning." }, "source": { "id": "src_067ce3340f851c18", "label": "FDA：LOZOL 2021 年补充批准函（脉络膜积液/闭角型青光眼警示更新）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/018538Orig1s030ltr.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_regulatory_document", "documentKind": "regulatory_approval_letter", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" } }, { "date": "2025-09-12", "title": { "zh": "ANI 当前通用药标签更新", "en": "Current ANI generic label update" }, "detail": { "zh": "1.25/2.5 mg、100 片瓶装文字与包装面板可公开阅读。", "en": "Text and package panels for 1.25/2.5 mg 100-tablet bottles are publicly readable." }, "source": { "id": "src_75b816aca5469bf8", "label": "DailyMed（NLM）：ANI 吲达帕胺 1.25／2.5 mg 当前美国通用药标签及包装面板（2025-09 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=deb83f97-6c61-4a09-bed6-18dcf1183405", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" } } ], "marketStatus": [ { "market": { "zh": "美国 LOZOL", "en": "United States — LOZOL" }, "status": { "zh": "历史原研/RLD，已停市", "en": "Historical originator/RLD; discontinued" }, "detail": { "zh": "FDA 认定不是因安全性或有效性原因撤回。", "en": "FDA determined that withdrawal was not for safety or effectiveness reasons." } }, { "market": { "zh": "美国 ANI 通用药", "en": "United States — ANI generic" }, "status": { "zh": "当前公开通用药标签", "en": "Current public generic label" }, "detail": { "zh": "ANDA 074299；1.25/2.5 mg，100 片瓶装。", "en": "ANDA 074299; 1.25/2.5 mg in 100-tablet bottles." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "图片里的是 LOZOL 原研包装吗？", "en": "Is the pictured pack original LOZOL?" }, "answer": { "zh": "不是。图片是 ANI 当前通用药标签；LOZOL 只作为历史原研/RLD 身份展示。", "en": "No. The image is a current ANI generic label; LOZOL is shown only as the historical originator/RLD identity." } }, { "question": { "zh": "吲达帕胺和氯噻酮、氢氯噻嗪能按毫克换吗？", "en": "Can indapamide be converted by milligrams to chlorthalidone or hydrochlorothiazide?" }, "answer": { "zh": "不能由网页或毫克数自行换算。它们是不同药物，作用时程、标签、监测和个体风险不同。", "en": "Not by the site or milligram arithmetic. They are different medicines with different duration, labels, monitoring and individual risks." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "dose-unit-literacy", "same-class-is-not-same-medicine", "interactions-are-not-a-home-scheduling-problem" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/lozol-indapamide/", "en": "https://origindrug.com/en/drugs/lozol-indapamide/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "deltasone-prednisone", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-09-02", "status": "published_traceable_archive" }, "names": { "brand": "DELTASONE / prednisone", "generic": "泼尼松普通片", "aliases": [ "DELTASONE", "Deltasone", "prednisone", "prednisone tablets", "泼尼松", "泼尼松片", "强的松", "prednisone immediate release", "NDA 009986", "ANDA 212629", "63561-0120-01", "63561-0120-05", "63561-0120-02", "63561-0121-01", "63561-0121-05", "63561-0121-02", "63561-0122-01", "63561-0122-05", "63561-0122-02", "Є 171", "Є 172", "Є 173" ], "marketBrandNames": [ { "name": "DELTASONE", "market": { "zh": "美国", "en": "United States" }, "evidenceStatus": "historical_regulatory_record", "note": { "zh": "NDA 009986 历史原研/RLD；2.5、5、10、20、50 mg 当前均列 DISCN，并注明并非因安全性或有效性撤回。本页不展示其原品牌包装。", "en": "Historical originator/RLD under NDA 009986. The 2.5, 5, 10, 20 and 50 mg rows are currently DISCN and marked as not withdrawn for safety or effectiveness. This page does not display an original-brand pack." }, "source": { "id": "src_9bee8c0c74da02f8", "label": "FDA Drugs@FDA：DELTASONE／prednisone NDA 009986 五个历史 RLD 规格与 DISCN 状态", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=009986", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" } }, { "name": "prednisone tablets", "market": { "zh": "美国", "en": "United States" }, "evidenceStatus": "current_regulatory_record", "note": { "zh": "ANDA 212629 当前通用药标签；5、10、20 mg，各有 100、500、1000 片瓶装。监管标签不等于实时库存。", "en": "Current generic label under ANDA 212629; 5, 10 and 20 mg in 100-, 500- and 1000-tablet bottles. A regulatory label is not live stock." }, "source": { "id": "src_14f31f8a4f7f43f6", "label": "DailyMed（NLM）：泼尼松普通片 5／10／20 mg 当前美国通用药标签、九个瓶装 NDC 与包装面板（ANDA 212629；2025-08 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a173fcbb-99be-4b3e-a3a4-4e9ae04ad83f", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" } } ], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "免疫", "sourceArchiveMarket": "FDA Drugs@FDA 当前数据把 DELTASONE NDA 009986 的 2.5、5、10、20、50 mg 五个规格列为历史 RLD、当前 DISCN，并标注并非因安全性或有效性撤回。当前准确包装来自 ANDA 212629 通用药标签：5、10、20 mg，每种均有 100、500、1000 片瓶装和准确公开面板。历史品牌、当前通用药、RAYOS 延迟释放片和其他市场供应不得混写。", "dosageFormClass": "泼尼松普通口服片。DELTASONE 历史原研、当前通用药、RAYOS 延迟释放片、泼尼松龙、甲泼尼龙及其他糖皮质激素是不同产品或成分；共同“激素”用途和 mg 数字不建立剂量换算、分片、减量或替换结论。", "dosageFormClassCode": "oral_modified_release", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "1955（DELTASONE 美国初始批准年份）", "archiveSponsorText": "DELTASONE 历史原研/RLD；Granulation Technology, Inc. 为当前展示通用药标签方" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [ "DELTASONE", "prednisone", "prednisone tablets", "泼尼松", "泼尼松片", "强的松" ], "excludedProductCues": [ "RAYOS", "prednisone delayed-release", "MEDROL", "methylprednisolone", "prednisolone", "泼尼松龙", "甲泼尼龙" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-generic-prednisone-ir-5mg-100-tablet-bottle-ndc-63561012001", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国通用药标签（2025-08-15 修订）", "en": "Current U.S. DailyMed generic label (revised 15 Aug 2025)" }, "dosageForm": { "zh": "泼尼松普通口服片", "en": "prednisone immediate-release oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 63561-0120-01", "pouchCode": null, "applicationNumber": "ANDA 212629", "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片泼尼松 5 mg；100 片瓶装", "en": "5 mg prednisone per tablet; 100-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=pred-5mg-100+ct.jpg&setid=a173fcbb-99be-4b3e-a3a4-4e9ae04ad83f&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "泼尼松", "en": "prednisone" }, "value": 5, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、疗程、减量步骤，也不是与 RAYOS、MEDROL 或其他激素的换算值", "en": "labelled amount per tablet; not an individual's tablet count, course, taper or conversion to RAYOS, MEDROL or another corticosteroid" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-02", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "current_regulatory_listing_not_live_stock", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "白色", "en": "white" }, "shape": { "zh": "圆形普通片", "en": "round immediate-release tablet" }, "imprint": "Є 171", "scoreStatus": "scored_not_self_split_permission", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_14f31f8a4f7f43f6", "label": "DailyMed（NLM）：泼尼松普通片 5／10／20 mg 当前美国通用药标签、九个瓶装 NDC 与包装面板（ANDA 212629；2025-08 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a173fcbb-99be-4b3e-a3a4-4e9ae04ad83f", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-generic-prednisone-ir-5mg-500-tablet-bottle-ndc-63561012005", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国通用药标签（2025-08-15 修订）", "en": "Current U.S. DailyMed generic label (revised 15 Aug 2025)" }, "dosageForm": { "zh": "泼尼松普通口服片", "en": "prednisone immediate-release oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 63561-0120-05", "pouchCode": null, "applicationNumber": "ANDA 212629", "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片泼尼松 5 mg；500 片瓶装", "en": "5 mg prednisone per tablet; 500-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=pred-5mg-500+ct.jpg&setid=a173fcbb-99be-4b3e-a3a4-4e9ae04ad83f&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "泼尼松", "en": "prednisone" }, "value": 5, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、疗程、减量步骤，也不是与 RAYOS、MEDROL 或其他激素的换算值", "en": "labelled amount per tablet; not an individual's tablet count, course, taper or conversion to RAYOS, MEDROL or another corticosteroid" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 500, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-02", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "current_regulatory_listing_not_live_stock", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 500, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "白色", "en": "white" }, "shape": { "zh": "圆形普通片", "en": "round immediate-release tablet" }, "imprint": "Є 171", "scoreStatus": "scored_not_self_split_permission", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_14f31f8a4f7f43f6", "label": "DailyMed（NLM）：泼尼松普通片 5／10／20 mg 当前美国通用药标签、九个瓶装 NDC 与包装面板（ANDA 212629；2025-08 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a173fcbb-99be-4b3e-a3a4-4e9ae04ad83f", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-generic-prednisone-ir-5mg-1000-tablet-bottle-ndc-63561012002", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国通用药标签（2025-08-15 修订）", "en": "Current U.S. DailyMed generic label (revised 15 Aug 2025)" }, "dosageForm": { "zh": "泼尼松普通口服片", "en": "prednisone immediate-release oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 63561-0120-02", "pouchCode": null, "applicationNumber": "ANDA 212629", "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片泼尼松 5 mg；1000 片瓶装", "en": "5 mg prednisone per tablet; 1000-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=pred-5mg-1000+ct.jpg&setid=a173fcbb-99be-4b3e-a3a4-4e9ae04ad83f&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "泼尼松", "en": "prednisone" }, "value": 5, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、疗程、减量步骤，也不是与 RAYOS、MEDROL 或其他激素的换算值", "en": "labelled amount per tablet; not an individual's tablet count, course, taper or conversion to RAYOS, MEDROL or another corticosteroid" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 1000, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-02", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "current_regulatory_listing_not_live_stock", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 1000, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "白色", "en": "white" }, "shape": { "zh": "圆形普通片", "en": "round immediate-release tablet" }, "imprint": "Є 171", "scoreStatus": "scored_not_self_split_permission", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_14f31f8a4f7f43f6", "label": "DailyMed（NLM）：泼尼松普通片 5／10／20 mg 当前美国通用药标签、九个瓶装 NDC 与包装面板（ANDA 212629；2025-08 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a173fcbb-99be-4b3e-a3a4-4e9ae04ad83f", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-generic-prednisone-ir-10mg-100-tablet-bottle-ndc-63561012101", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国通用药标签（2025-08-15 修订）", "en": "Current U.S. DailyMed generic label (revised 15 Aug 2025)" }, "dosageForm": { "zh": "泼尼松普通口服片", "en": "prednisone immediate-release oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 63561-0121-01", "pouchCode": null, "applicationNumber": "ANDA 212629", "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片泼尼松 10 mg；100 片瓶装", "en": "10 mg prednisone per tablet; 100-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=pred-10mg-100+ct.jpg&setid=a173fcbb-99be-4b3e-a3a4-4e9ae04ad83f&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "泼尼松", "en": "prednisone" }, "value": 10, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、疗程、减量步骤，也不是与 RAYOS、MEDROL 或其他激素的换算值", "en": "labelled amount per tablet; not an individual's tablet count, course, taper or conversion to RAYOS, MEDROL or another corticosteroid" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-02", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "current_regulatory_listing_not_live_stock", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "白色", "en": "white" }, "shape": { "zh": "圆形普通片", "en": "round immediate-release tablet" }, "imprint": "Є 172", "scoreStatus": "scored_not_self_split_permission", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_14f31f8a4f7f43f6", "label": "DailyMed（NLM）：泼尼松普通片 5／10／20 mg 当前美国通用药标签、九个瓶装 NDC 与包装面板（ANDA 212629；2025-08 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a173fcbb-99be-4b3e-a3a4-4e9ae04ad83f", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-generic-prednisone-ir-10mg-500-tablet-bottle-ndc-63561012105", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国通用药标签（2025-08-15 修订）", "en": "Current U.S. DailyMed generic label (revised 15 Aug 2025)" }, "dosageForm": { "zh": "泼尼松普通口服片", "en": "prednisone immediate-release oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 63561-0121-05", "pouchCode": null, "applicationNumber": "ANDA 212629", "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片泼尼松 10 mg；500 片瓶装", "en": "10 mg prednisone per tablet; 500-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=pred-10mg-500+ct.jpg&setid=a173fcbb-99be-4b3e-a3a4-4e9ae04ad83f&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "泼尼松", "en": "prednisone" }, "value": 10, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、疗程、减量步骤，也不是与 RAYOS、MEDROL 或其他激素的换算值", "en": "labelled amount per tablet; not an individual's tablet count, course, taper or conversion to RAYOS, MEDROL or another corticosteroid" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 500, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-02", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "current_regulatory_listing_not_live_stock", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 500, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "白色", "en": "white" }, "shape": { "zh": "圆形普通片", "en": "round immediate-release tablet" }, "imprint": "Є 172", "scoreStatus": "scored_not_self_split_permission", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_14f31f8a4f7f43f6", "label": "DailyMed（NLM）：泼尼松普通片 5／10／20 mg 当前美国通用药标签、九个瓶装 NDC 与包装面板（ANDA 212629；2025-08 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a173fcbb-99be-4b3e-a3a4-4e9ae04ad83f", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-generic-prednisone-ir-10mg-1000-tablet-bottle-ndc-63561012102", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国通用药标签（2025-08-15 修订）", "en": "Current U.S. DailyMed generic label (revised 15 Aug 2025)" }, "dosageForm": { "zh": "泼尼松普通口服片", "en": "prednisone immediate-release oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 63561-0121-02", "pouchCode": null, "applicationNumber": "ANDA 212629", "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片泼尼松 10 mg；1000 片瓶装", "en": "10 mg prednisone per tablet; 1000-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=pred-10mg-1000+ct.jpg&setid=a173fcbb-99be-4b3e-a3a4-4e9ae04ad83f&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "泼尼松", "en": "prednisone" }, "value": 10, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、疗程、减量步骤，也不是与 RAYOS、MEDROL 或其他激素的换算值", "en": "labelled amount per tablet; not an individual's tablet count, course, taper or conversion to RAYOS, MEDROL or another corticosteroid" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 1000, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-02", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "current_regulatory_listing_not_live_stock", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 1000, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "白色", "en": "white" }, "shape": { "zh": "圆形普通片", "en": "round immediate-release tablet" }, "imprint": "Є 172", "scoreStatus": "scored_not_self_split_permission", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_14f31f8a4f7f43f6", "label": "DailyMed（NLM）：泼尼松普通片 5／10／20 mg 当前美国通用药标签、九个瓶装 NDC 与包装面板（ANDA 212629；2025-08 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a173fcbb-99be-4b3e-a3a4-4e9ae04ad83f", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-generic-prednisone-ir-20mg-100-tablet-bottle-ndc-63561012201", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国通用药标签（2025-08-15 修订）", "en": "Current U.S. DailyMed generic label (revised 15 Aug 2025)" }, "dosageForm": { "zh": "泼尼松普通口服片", "en": "prednisone immediate-release oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 63561-0122-01", "pouchCode": null, "applicationNumber": "ANDA 212629", "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片泼尼松 20 mg；100 片瓶装", "en": "20 mg prednisone per tablet; 100-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=pred-20mg-100+ct.jpg&setid=a173fcbb-99be-4b3e-a3a4-4e9ae04ad83f&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "泼尼松", "en": "prednisone" }, "value": 20, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、疗程、减量步骤，也不是与 RAYOS、MEDROL 或其他激素的换算值", "en": "labelled amount per tablet; not an individual's tablet count, course, taper or conversion to RAYOS, MEDROL or another corticosteroid" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-02", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "current_regulatory_listing_not_live_stock", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "白色", "en": "white" }, "shape": { "zh": "圆形普通片", "en": "round immediate-release tablet" }, "imprint": "Є 173", "scoreStatus": "scored_not_self_split_permission", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_14f31f8a4f7f43f6", "label": "DailyMed（NLM）：泼尼松普通片 5／10／20 mg 当前美国通用药标签、九个瓶装 NDC 与包装面板（ANDA 212629；2025-08 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a173fcbb-99be-4b3e-a3a4-4e9ae04ad83f", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-generic-prednisone-ir-20mg-500-tablet-bottle-ndc-63561012205", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国通用药标签（2025-08-15 修订）", "en": "Current U.S. DailyMed generic label (revised 15 Aug 2025)" }, "dosageForm": { "zh": "泼尼松普通口服片", "en": "prednisone immediate-release oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 63561-0122-05", "pouchCode": null, "applicationNumber": "ANDA 212629", "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片泼尼松 20 mg；500 片瓶装", "en": "20 mg prednisone per tablet; 500-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=pred-20mg-500+ct.jpg&setid=a173fcbb-99be-4b3e-a3a4-4e9ae04ad83f&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "泼尼松", "en": "prednisone" }, "value": 20, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、疗程、减量步骤，也不是与 RAYOS、MEDROL 或其他激素的换算值", "en": "labelled amount per tablet; not an individual's tablet count, course, taper or conversion to RAYOS, MEDROL or another corticosteroid" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 500, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-02", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "current_regulatory_listing_not_live_stock", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 500, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "白色", "en": "white" }, "shape": { "zh": "圆形普通片", "en": "round immediate-release tablet" }, "imprint": "Є 173", "scoreStatus": "scored_not_self_split_permission", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_14f31f8a4f7f43f6", "label": "DailyMed（NLM）：泼尼松普通片 5／10／20 mg 当前美国通用药标签、九个瓶装 NDC 与包装面板（ANDA 212629；2025-08 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a173fcbb-99be-4b3e-a3a4-4e9ae04ad83f", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-generic-prednisone-ir-20mg-1000-tablet-bottle-ndc-63561012202", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国通用药标签（2025-08-15 修订）", "en": "Current U.S. DailyMed generic label (revised 15 Aug 2025)" }, "dosageForm": { "zh": "泼尼松普通口服片", "en": "prednisone immediate-release oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 63561-0122-02", "pouchCode": null, "applicationNumber": "ANDA 212629", "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片泼尼松 20 mg；1000 片瓶装", "en": "20 mg prednisone per tablet; 1000-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=pred-20mg-1000+ct.jpg&setid=a173fcbb-99be-4b3e-a3a4-4e9ae04ad83f&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "泼尼松", "en": "prednisone" }, "value": 20, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、疗程、减量步骤，也不是与 RAYOS、MEDROL 或其他激素的换算值", "en": "labelled amount per tablet; not an individual's tablet count, course, taper or conversion to RAYOS, MEDROL or another corticosteroid" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 1000, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-02", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "current_regulatory_listing_not_live_stock", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 1000, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "白色", "en": "white" }, "shape": { "zh": "圆形普通片", "en": "round immediate-release tablet" }, "imprint": "Є 173", "scoreStatus": "scored_not_self_split_permission", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_14f31f8a4f7f43f6", "label": "DailyMed（NLM）：泼尼松普通片 5／10／20 mg 当前美国通用药标签、九个瓶装 NDC 与包装面板（ANDA 212629；2025-08 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a173fcbb-99be-4b3e-a3a4-4e9ae04ad83f", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-generic-prednisone-ir-5mg-100-tablet-bottle-ndc-63561012001", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=pred-5mg-100+ct.jpg&setid=a173fcbb-99be-4b3e-a3a4-4e9ae04ad83f&type=img", "alt": "Granulation Technology 泼尼松 5 mg、NDC 63561-0120-01、100 片瓶装的 DailyMed 官方通用药标签面板", "archiveMarket": "美国", "labelVersion": "DailyMed 当前美国通用药标签（2025-08）", "presentation": "5 mg：白色圆片、刻痕、Є 171；NDC 63561-0120-01，100 片瓶装。另有 10/20 mg 和 500/1000 片准确面板。", "notice": "此图是当前通用药包装标签，不是 DELTASONE 原品牌包装；只对应 NDC 63561-0120-01，不代表 RAYOS、MEDROL、泼尼松龙、其他厂商或其他市场，也不用于鉴定真伪。", "source": { "id": "src_14f31f8a4f7f43f6", "label": "DailyMed（NLM）：泼尼松普通片 5／10／20 mg 当前美国通用药标签、九个瓶装 NDC 与包装面板（ANDA 212629；2025-08 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a173fcbb-99be-4b3e-a3a4-4e9ae04ad83f", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "泼尼松说明书放大阅读：每片 mg、整瓶片数、感染、突然停药与多药风险", "en": "Prednisone enlarged label: per-tablet mg, bottle count, infection, abrupt withdrawal and polypharmacy risk" }, "summary": { "zh": "5、10、20 mg 是每片含量；100、500、1000 Tablets 是整瓶片数。每片有刻痕也不能据此自行掰片。用法和是否需要逐步调整取决于准确处方、使用时间、疾病、感染风险和其他药物，网页不生成个人计划。", "en": "The 5, 10 and 20 mg figures are amounts per tablet; 100, 500 and 1000 Tablets are bottle counts. A score does not permit self-splitting. Use and whether gradual adjustment is needed depend on the exact prescription, duration, disease, infection risk and other medicines; the site does not generate an individual plan." }, "checks": [ { "zh": "糖皮质激素会抑制免疫并增加病毒、细菌、真菌、寄生虫等感染风险，也可能掩盖部分感染表现。发热、气促、意识变化、明显虚弱、带状疱疹/水痘/麻疹暴露或快速恶化，应及时联系治疗团队，严重时使用当地急救。", "en": "Corticosteroids suppress immune function and increase viral, bacterial, fungal and parasitic infection risk, and may mask some infection signs. Fever, breathing difficulty, altered awareness, marked weakness, shingles/chickenpox/measles exposure or rapid deterioration needs prompt treating-team review and emergency care when severe." }, { "zh": "连续或较长时间使用后，突然停用可能出现肾上腺功能不足或撤药问题。不要因为感觉好转、血糖/血压变化或药盒快用完，就自行骤停、隔天轮换或照搬网上减量表；漏服、多服或断药应核对准确处方。", "en": "After continuous or longer use, abrupt withdrawal can cause adrenal insufficiency or withdrawal problems. Do not abruptly stop, alternate days or copy an online taper because symptoms improve, glucose or pressure changes, or the pack is nearly empty. Missed, extra or interrupted use requires review of the exact prescription." }, { "zh": "老人和多药使用者应优先核对血糖、血压、水肿/钠钾、骨质疏松与骨折、肌无力、胃肠道出血、眼压/白内障、情绪睡眠或意识变化和跌倒；网页不能凭一个化验值或症状决定继续、减量或停药。", "en": "Older adults and people with several medicines require priority review of glucose, blood pressure, oedema/sodium/potassium, osteoporosis/fracture, muscle weakness, gastrointestinal bleeding, eye pressure/cataract, mood/sleep or awareness changes and falls. One laboratory value or symptom cannot let the site decide continuation, reduction or stopping." }, { "zh": "NSAID 止痛药、抗凝/抗血小板药、利尿剂、地高辛、降糖药、环孢素、某些抗感染药和疫苗同处药单时需要专业核对。免疫抑制剂量下活疫苗存在重要边界；不要自行安排错开时间、加胃药或停掉其中一盒。", "en": "An NSAID pain medicine, anticoagulant/antiplatelet, diuretic, digoxin, glucose-lowering medicine, ciclosporin, selected anti-infectives or a vaccine on the same list requires professional review. Live vaccines have an important boundary during immunosuppressive dosing; do not invent spacing, add a stomach medicine or remove a pack yourself." } ], "source": { "id": "src_14f31f8a4f7f43f6", "label": "DailyMed（NLM）：泼尼松普通片 5／10／20 mg 当前美国通用药标签、九个瓶装 NDC 与包装面板（ANDA 212629；2025-08 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a173fcbb-99be-4b3e-a3a4-4e9ae04ad83f", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "泼尼松为何能减轻炎症：广泛改变炎症、代谢与免疫反应，不是单一止痛开关", "en": "Why prednisone can reduce inflammation: broad inflammatory, metabolic and immune effects, not a single pain switch" }, "summary": { "zh": "当前标签把泼尼松归为合成糖皮质激素，说明其具有强效抗炎作用、广泛代谢影响并改变机体对多种刺激的免疫反应。这可以解释多系统疗效和风险同时存在，但不能由机制推导个人适应证、片数、疗程或减量速度。", "en": "The current label identifies prednisone as a synthetic glucocorticoid with potent anti-inflammatory effects, broad metabolic effects and modification of immune responses to diverse stimuli. This helps explain simultaneous multisystem benefit and risk, but cannot derive an individual's indication, tablet count, course or taper speed." }, "checks": [ { "zh": "泼尼松普通片、RAYOS 延迟释放泼尼松、泼尼松龙、甲泼尼龙、地塞米松和氢化可的松不是可以按 mg 一比一换算的同一种药；也不能按共同“激素”名称自行叠加或轮换。", "en": "Immediate-release prednisone, RAYOS delayed-release prednisone, prednisolone, methylprednisolone, dexamethasone and hydrocortisone are not one medicine that can be converted one-to-one by milligrams, or self-combined or alternated from a shared corticosteroid label." }, { "zh": "抗炎作用可能让疼痛、皮疹或发热暂时减轻，但不等于病因已经消失，也不等于可以自行停抗感染药、增加激素或延长疗程。", "en": "Anti-inflammatory effects may temporarily reduce pain, rash or fever, but do not prove the cause has resolved or permit self-stopping an anti-infective, increasing the corticosteroid or extending a course." }, { "zh": "同样的每片 mg 在不同疾病、使用时间、年龄、肝肾情况和并用药下意义不同。网页只帮助识别准确产品和说明书边界，不计算“等效激素剂量”。", "en": "The same per-tablet milligram figure has different context across diseases, duration, age, liver/kidney status and co-medication. The site identifies the exact product and label boundary and does not calculate an equivalent corticosteroid dose." } ], "source": { "id": "src_14f31f8a4f7f43f6", "label": "DailyMed（NLM）：泼尼松普通片 5／10／20 mg 当前美国通用药标签、九个瓶装 NDC 与包装面板（ANDA 212629；2025-08 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a173fcbb-99be-4b3e-a3a4-4e9ae04ad83f", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "DELTASONE / prednisone", "generic": "泼尼松普通片", "dosageFormClass": "泼尼松普通口服片。DELTASONE 历史原研、当前通用药、RAYOS 延迟释放片、泼尼松龙、甲泼尼龙及其他糖皮质激素是不同产品或成分；共同“激素”用途和 mg 数字不建立剂量换算、分片、减量或替换结论。" }, "labelSource": { "id": "src_14f31f8a4f7f43f6", "label": "DailyMed（NLM）：泼尼松普通片 5／10／20 mg 当前美国通用药标签、九个瓶装 NDC 与包装面板（ANDA 212629；2025-08 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a173fcbb-99be-4b3e-a3a4-4e9ae04ad83f", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, "productRoutes": [ { "source": { "id": "src_14f31f8a4f7f43f6", "label": "DailyMed（NLM）：泼尼松普通片 5／10／20 mg 当前美国通用药标签、九个瓶装 NDC 与包装面板（ANDA 212629；2025-08 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a173fcbb-99be-4b3e-a3a4-4e9ae04ad83f", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-09-02", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_9bee8c0c74da02f8", "label": "FDA Drugs@FDA：DELTASONE／prednisone NDA 009986 五个历史 RLD 规格与 DISCN 状态", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=009986", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-09-02", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-09-02", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "DELTASONE 是泼尼松普通片的美国历史原研/RLD；本页可见九个面板是当前通用药，不是原品牌包装。5/10/20 mg 是每片含量，100/500/1000 Tablets 是整瓶片数。泼尼松可能抑制免疫并影响血糖、情绪/睡眠、骨骼、胃肠、水盐和眼睛；连续或较长时间使用后突然停药可能有风险。网页不生成个人疗程、片数、减量表、隔天方案或与其他激素的换算。", "history": "FDA 审评记录 prednisone 于 1955 年以 DELTASONE 和 METICORTEN 在美国首次获批。当前 DELTASONE 五个历史 RLD 规格均为 DISCN；DailyMed 当前通用药标签修订于 2025-08-15。RAYOS 是另一个 NDA 下的延迟释放泼尼松产品，不能把普通片历史或标签直接套用到延迟释放片。", "sourceDocuments": [ { "id": "src_14f31f8a4f7f43f6", "label": "DailyMed（NLM）：泼尼松普通片 5／10／20 mg 当前美国通用药标签、九个瓶装 NDC 与包装面板（ANDA 212629；2025-08 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a173fcbb-99be-4b3e-a3a4-4e9ae04ad83f", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, { "id": "src_9bee8c0c74da02f8", "label": "FDA Drugs@FDA：DELTASONE／prednisone NDA 009986 五个历史 RLD 规格与 DISCN 状态", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=009986", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, { "id": "src_a017eea207be0826", "label": "FDA：泼尼松普通片 1955 年 DELTASONE／METICORTEN 初始批准历史及 RAYOS 延迟释放剂型审评背景", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202020Orig1s000ClinPharmR.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_regulatory_document", "documentKind": "regulatory_review", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" } ], "applicationNumber": "DELTASONE NDA 009986（历史原研/RLD）；prednisone ANDA 212629（当前通用药标签）", "approvalTimeline": [ { "date": "1955", "title": { "zh": "DELTASONE 与 METICORTEN 在美国初始批准", "en": "Initial U.S. approval of DELTASONE and METICORTEN" }, "detail": { "zh": "FDA 临床药理审评记录 prednisone 于 1955 年以 DELTASONE NDA 009986 和 METICORTEN NDA 009766 首次获批。", "en": "FDA clinical-pharmacology review records initial U.S. prednisone approval in 1955 as DELTASONE NDA 009986 and METICORTEN NDA 009766." }, "source": { "id": "src_a017eea207be0826", "label": "FDA：泼尼松普通片 1955 年 DELTASONE／METICORTEN 初始批准历史及 RAYOS 延迟释放剂型审评背景", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202020Orig1s000ClinPharmR.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_regulatory_document", "documentKind": "regulatory_review", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" } }, { "date": "2026-09-02", "title": { "zh": "当前 Drugs@FDA 历史品牌状态核验", "en": "Current Drugs@FDA historical-brand status verification" }, "detail": { "zh": "五个 DELTASONE 规格均为 RLD、DISCN，并逐行标明并非因安全性或有效性撤回。", "en": "All five DELTASONE strengths are RLD and DISCN, with each row marked as not withdrawn for safety or effectiveness." }, "source": { "id": "src_9bee8c0c74da02f8", "label": "FDA Drugs@FDA：DELTASONE／prednisone NDA 009986 五个历史 RLD 规格与 DISCN 状态", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=009986", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" } }, { "date": "2025-08-15", "title": { "zh": "当前通用药标签修订", "en": "Current generic label revision" }, "detail": { "zh": "ANDA 212629 的 5/10/20 mg、九个瓶装 NDC 与包装面板可公开阅读。", "en": "The 5/10/20 mg, nine bottle NDCs and package panels under ANDA 212629 are publicly readable." }, "source": { "id": "src_14f31f8a4f7f43f6", "label": "DailyMed（NLM）：泼尼松普通片 5／10／20 mg 当前美国通用药标签、九个瓶装 NDC 与包装面板（ANDA 212629；2025-08 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a173fcbb-99be-4b3e-a3a4-4e9ae04ad83f", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" } } ], "marketStatus": [ { "market": { "zh": "美国 DELTASONE", "en": "United States — DELTASONE" }, "status": { "zh": "历史原研/RLD，已停市", "en": "Historical originator/RLD; discontinued" }, "detail": { "zh": "NDA 009986；2.5、5、10、20、50 mg 当前均为 DISCN，且并非因安全性或有效性撤回。", "en": "NDA 009986; the 2.5, 5, 10, 20 and 50 mg rows are DISCN and not withdrawn for safety or effectiveness." } }, { "market": { "zh": "美国当前通用药", "en": "United States — current generic" }, "status": { "zh": "当前公开通用药标签", "en": "Current public generic label" }, "detail": { "zh": "ANDA 212629；5、10、20 mg，各有 100、500、1000 片瓶装。", "en": "ANDA 212629; 5, 10 and 20 mg in 100-, 500- and 1000-tablet bottles." } }, { "market": { "zh": "美国以外市场", "en": "Markets outside the United States" }, "status": { "zh": "本档案未确认当地品牌、规格、包装或供应", "en": "Local brand, strength, pack and supply are not established" }, "detail": { "zh": "必须按当地药监记录、现行说明书和手中药盒逐项核对。", "en": "Check the local regulator, current label and pack in hand item by item." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "照片里的是 DELTASONE 原研药盒吗？", "en": "Is the pictured pack the original DELTASONE pack?" }, "answer": { "zh": "不是。九个图片都是当前 ANDA 212629 通用药包装面板；DELTASONE 只作为历史原研/RLD 身份展示，本页没有把通用药图片冒充原品牌。", "en": "No. All nine images are current generic package panels under ANDA 212629. DELTASONE is shown only as the historical originator/RLD identity, and no generic image is presented as the original brand." } }, { "question": { "zh": "20 mg 有刻痕，能不能掰成两片 10 mg？", "en": "The 20 mg tablet is scored. Can it be split into two 10 mg halves?" }, "answer": { "zh": "不能由刻痕和算术自行决定。20 mg 与 10 mg 是不同准确产品；分片还涉及处方、产品标签、均一性、疗程和药师确认。网页只记录刻痕，不生成掰片或减量许可。", "en": "Not from a score and arithmetic alone. The 20 mg and 10 mg are distinct exact products, and splitting also depends on the prescription, product label, uniformity, course and pharmacist review. The site records the score but does not issue splitting or taper permission." } }, { "question": { "zh": "泼尼松、RAYOS 和甲泼尼龙可以按 mg 换着吃吗？", "en": "Can prednisone, RAYOS and methylprednisolone be alternated by milligrams?" }, "answer": { "zh": "不能。RAYOS 是延迟释放泼尼松，MEDROL 是甲泼尼龙；释放方式、成分、作用时程和处方安排不同，网页不提供换算或替换方案。", "en": "No. RAYOS is delayed-release prednisone and MEDROL is methylprednisolone. Release, ingredient, duration and prescription arrangements differ, and the site provides no conversion or substitution plan." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "dose-unit-literacy", "same-class-is-not-same-medicine", "interactions-are-not-a-home-scheduling-problem" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/deltasone-prednisone/", "en": "https://origindrug.com/en/drugs/deltasone-prednisone/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "apresoline-hydralazine", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-09-02", "status": "published_traceable_archive" }, "names": { "brand": "APRESOLINE / hydralazine", "generic": "盐酸肼屈嗪普通片", "aliases": [ "APRESOLINE", "Apresoline", "hydralazine", "hydralazine hydrochloride", "hydralazine tablets", "肼屈嗪", "盐酸肼屈嗪", "盐酸肼屈嗪片", "NDA 008303", "ANDA 200770", "64380-733-06", "64380-733-07", "64380-733-08", "64380-734-06", "64380-734-07", "64380-734-08", "64380-735-06", "64380-735-07", "64380-735-08", "64380-736-06", "64380-736-07", "64380-736-08" ], "marketBrandNames": [ { "name": "APRESOLINE", "market": { "zh": "美国", "en": "United States" }, "evidenceStatus": "historical_regulatory_record", "note": { "zh": "NDA 008303 历史原研/RLD；10、25、50、100 mg 口服片当前均列 DISCN，并注明并非因安全性或有效性撤回。本页不展示其历史原品牌包装。", "en": "Historical originator/RLD under NDA 008303. The 10, 25, 50 and 100 mg oral tablets are currently DISCN and marked as not withdrawn for safety or effectiveness. This page does not display a historical original-brand pack." }, "source": { "id": "src_58616678e6f146bc", "label": "FDA Drugs@FDA：APRESOLINE／hydralazine hydrochloride NDA 008303 的 1953 年初始批准、四个口服片历史 RLD 与 DISCN 状态", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=008303", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" } }, { "name": "hydralazine hydrochloride tablets", "market": { "zh": "美国", "en": "United States" }, "evidenceStatus": "current_regulatory_record", "note": { "zh": "Strides ANDA 200770 当前通用药标签；10、25、50、100 mg，各有 100、500、1000 片瓶装。监管标签不等于实时库存。", "en": "Current Strides generic label under ANDA 200770; 10, 25, 50 and 100 mg, each in 100-, 500- and 1000-tablet bottles. A regulatory label is not live stock." }, "source": { "id": "src_376f33db229a46b7", "label": "DailyMed（NLM）：盐酸肼屈嗪普通片 10／25／50／100 mg 当前美国通用药标签、十二个瓶装 NDC 与四个准确包装面板（ANDA 200770；2026 年标签）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b3d1786d-c3ff-42f1-a09f-37a9c9021e5a", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" } } ], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "心血管", "sourceArchiveMarket": "FDA Drugs@FDA 当前数据把 APRESOLINE NDA 008303 的 10、25、50、100 mg 口服片列为历史 RLD、当前 DISCN，并逐项标注并非因安全性或有效性撤回。当前准确包装来自 Strides ANDA 200770 通用药标签：10、25、50、100 mg，每种均有 100、500、1000 片瓶装；本页只为四个经原始包装面板逐一核对的 NDC 展示图片。历史品牌、当前通用药、APRESOLINE 注射剂、BIDIL 固定复方和其他市场供应不得混写。", "dosageFormClass": "盐酸肼屈嗪普通口服片；不并入本页口服片身份的产品包括 20 mg/mL 注射剂、BIDIL 硝酸异山梨酯/盐酸肼屈嗪固定复方及其他降压药。APRESOLINE 历史原研与当前通用药也必须分开；共同成分、用途或 mg 数字不建立换算、片数、频次、递增、分片或替换结论。", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "1953（APRESOLINE 美国初始批准年份）", "archiveSponsorText": "APRESOLINE 历史原研/RLD（Novartis）；Strides Pharma Science Limited 为当前展示通用药标签方" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [ "APRESOLINE", "hydralazine", "hydralazine hydrochloride", "hydralazine tablets", "肼屈嗪", "盐酸肼屈嗪", "盐酸肼屈嗪片" ], "excludedProductCues": [ "APRESOLINE Injection", "hydralazine injection", "hydralazine 20 mg/mL", "BIDIL", "isosorbide dinitrate and hydralazine hydrochloride", "isosorbide dinitrate", "ISORDIL", "硝酸异山梨酯", "肼屈嗪注射液" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-generic-hydralazine-ir-10mg-100-tablet-bottle-ndc-6438073306", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国通用药标签（2026）", "en": "Current U.S. DailyMed generic label (2026)" }, "dosageForm": { "zh": "盐酸肼屈嗪普通口服片", "en": "hydralazine hydrochloride immediate-release oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 64380-733-06", "pouchCode": null, "applicationNumber": "ANDA 200770", "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片盐酸肼屈嗪 10 mg；100 片瓶装", "en": "10 mg hydralazine hydrochloride per tablet; 100-tablet bottle" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "盐酸肼屈嗪", "en": "hydralazine hydrochloride" }, "value": 10, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、频次、递增步骤、目标血压，也不是与 APRESOLINE 注射剂、BIDIL 或另一种降压药的换算值", "en": "labelled amount per tablet; not an individual's tablet count, frequency, titration step, target blood pressure or conversion to APRESOLINE injection, BIDIL or another antihypertensive" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-02", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "current_regulatory_listing_not_live_stock", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "橙色", "en": "orange" }, "shape": { "zh": "圆形双凸普通片", "en": "round, biconvex immediate-release tablet" }, "imprint": "10", "scoreStatus": "unscored_no_self_split_permission", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_376f33db229a46b7", "label": "DailyMed（NLM）：盐酸肼屈嗪普通片 10／25／50／100 mg 当前美国通用药标签、十二个瓶装 NDC 与四个准确包装面板（ANDA 200770；2026 年标签）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b3d1786d-c3ff-42f1-a09f-37a9c9021e5a", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-generic-hydralazine-ir-10mg-500-tablet-bottle-ndc-6438073307", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国通用药标签（2026）", "en": "Current U.S. DailyMed generic label (2026)" }, "dosageForm": { "zh": "盐酸肼屈嗪普通口服片", "en": "hydralazine hydrochloride immediate-release oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 64380-733-07", "pouchCode": null, "applicationNumber": "ANDA 200770", "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片盐酸肼屈嗪 10 mg；500 片瓶装", "en": "10 mg hydralazine hydrochloride per tablet; 500-tablet bottle" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "盐酸肼屈嗪", "en": "hydralazine hydrochloride" }, "value": 10, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、频次、递增步骤、目标血压，也不是与 APRESOLINE 注射剂、BIDIL 或另一种降压药的换算值", "en": "labelled amount per tablet; not an individual's tablet count, frequency, titration step, target blood pressure or conversion to APRESOLINE injection, BIDIL or another antihypertensive" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 500, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-02", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "current_regulatory_listing_not_live_stock", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 500, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "橙色", "en": "orange" }, "shape": { "zh": "圆形双凸普通片", "en": "round, biconvex immediate-release tablet" }, "imprint": "10", "scoreStatus": "unscored_no_self_split_permission", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_376f33db229a46b7", "label": "DailyMed（NLM）：盐酸肼屈嗪普通片 10／25／50／100 mg 当前美国通用药标签、十二个瓶装 NDC 与四个准确包装面板（ANDA 200770；2026 年标签）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b3d1786d-c3ff-42f1-a09f-37a9c9021e5a", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-generic-hydralazine-ir-10mg-1000-tablet-bottle-ndc-6438073308", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国通用药标签（2026）", "en": "Current U.S. DailyMed generic label (2026)" }, "dosageForm": { "zh": "盐酸肼屈嗪普通口服片", "en": "hydralazine hydrochloride immediate-release oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 64380-733-08", "pouchCode": null, "applicationNumber": "ANDA 200770", "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片盐酸肼屈嗪 10 mg；1000 片瓶装", "en": "10 mg hydralazine hydrochloride per tablet; 1000-tablet bottle" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "盐酸肼屈嗪", "en": "hydralazine hydrochloride" }, "value": 10, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、频次、递增步骤、目标血压，也不是与 APRESOLINE 注射剂、BIDIL 或另一种降压药的换算值", "en": "labelled amount per tablet; not an individual's tablet count, frequency, titration step, target blood pressure or conversion to APRESOLINE injection, BIDIL or another antihypertensive" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 1000, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-02", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "current_regulatory_listing_not_live_stock", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 1000, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "橙色", "en": "orange" }, "shape": { "zh": "圆形双凸普通片", "en": "round, biconvex immediate-release tablet" }, "imprint": "10", "scoreStatus": "unscored_no_self_split_permission", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_376f33db229a46b7", "label": "DailyMed（NLM）：盐酸肼屈嗪普通片 10／25／50／100 mg 当前美国通用药标签、十二个瓶装 NDC 与四个准确包装面板（ANDA 200770；2026 年标签）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b3d1786d-c3ff-42f1-a09f-37a9c9021e5a", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-generic-hydralazine-ir-25mg-100-tablet-bottle-ndc-6438073406", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国通用药标签（2026）", "en": "Current U.S. DailyMed generic label (2026)" }, "dosageForm": { "zh": "盐酸肼屈嗪普通口服片", "en": "hydralazine hydrochloride immediate-release oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 64380-734-06", "pouchCode": null, "applicationNumber": "ANDA 200770", "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片盐酸肼屈嗪 25 mg；100 片瓶装", "en": "25 mg hydralazine hydrochloride per tablet; 100-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=198e8715-f4c9-4b66-9e8e-61edab911f51-02.jpg&setid=b3d1786d-c3ff-42f1-a09f-37a9c9021e5a&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "盐酸肼屈嗪", "en": "hydralazine hydrochloride" }, "value": 25, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、频次、递增步骤、目标血压，也不是与 APRESOLINE 注射剂、BIDIL 或另一种降压药的换算值", "en": "labelled amount per tablet; not an individual's tablet count, frequency, titration step, target blood pressure or conversion to APRESOLINE injection, BIDIL or another antihypertensive" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-02", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "current_regulatory_listing_not_live_stock", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "橙色", "en": "orange" }, "shape": { "zh": "圆形、平面斜边普通片", "en": "round, flat bevel-edged immediate-release tablet" }, "imprint": "25", "scoreStatus": "unscored_no_self_split_permission", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_376f33db229a46b7", "label": "DailyMed（NLM）：盐酸肼屈嗪普通片 10／25／50／100 mg 当前美国通用药标签、十二个瓶装 NDC 与四个准确包装面板（ANDA 200770；2026 年标签）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b3d1786d-c3ff-42f1-a09f-37a9c9021e5a", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-generic-hydralazine-ir-25mg-500-tablet-bottle-ndc-6438073407", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国通用药标签（2026）", "en": "Current U.S. DailyMed generic label (2026)" }, "dosageForm": { "zh": "盐酸肼屈嗪普通口服片", "en": "hydralazine hydrochloride immediate-release oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 64380-734-07", "pouchCode": null, "applicationNumber": "ANDA 200770", "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片盐酸肼屈嗪 25 mg；500 片瓶装", "en": "25 mg hydralazine hydrochloride per tablet; 500-tablet bottle" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "盐酸肼屈嗪", "en": "hydralazine hydrochloride" }, "value": 25, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、频次、递增步骤、目标血压，也不是与 APRESOLINE 注射剂、BIDIL 或另一种降压药的换算值", "en": "labelled amount per tablet; not an individual's tablet count, frequency, titration step, target blood pressure or conversion to APRESOLINE injection, BIDIL or another antihypertensive" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 500, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-02", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "current_regulatory_listing_not_live_stock", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 500, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "橙色", "en": "orange" }, "shape": { "zh": "圆形、平面斜边普通片", "en": "round, flat bevel-edged immediate-release tablet" }, "imprint": "25", "scoreStatus": "unscored_no_self_split_permission", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_376f33db229a46b7", "label": "DailyMed（NLM）：盐酸肼屈嗪普通片 10／25／50／100 mg 当前美国通用药标签、十二个瓶装 NDC 与四个准确包装面板（ANDA 200770；2026 年标签）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b3d1786d-c3ff-42f1-a09f-37a9c9021e5a", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-generic-hydralazine-ir-25mg-1000-tablet-bottle-ndc-6438073408", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国通用药标签（2026）", "en": "Current U.S. DailyMed generic label (2026)" }, "dosageForm": { "zh": "盐酸肼屈嗪普通口服片", "en": "hydralazine hydrochloride immediate-release oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 64380-734-08", "pouchCode": null, "applicationNumber": "ANDA 200770", "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片盐酸肼屈嗪 25 mg；1000 片瓶装", "en": "25 mg hydralazine hydrochloride per tablet; 1000-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=198e8715-f4c9-4b66-9e8e-61edab911f51-03.jpg&setid=b3d1786d-c3ff-42f1-a09f-37a9c9021e5a&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "盐酸肼屈嗪", "en": "hydralazine hydrochloride" }, "value": 25, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、频次、递增步骤、目标血压，也不是与 APRESOLINE 注射剂、BIDIL 或另一种降压药的换算值", "en": "labelled amount per tablet; not an individual's tablet count, frequency, titration step, target blood pressure or conversion to APRESOLINE injection, BIDIL or another antihypertensive" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 1000, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-02", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "current_regulatory_listing_not_live_stock", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 1000, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "橙色", "en": "orange" }, "shape": { "zh": "圆形、平面斜边普通片", "en": "round, flat bevel-edged immediate-release tablet" }, "imprint": "25", "scoreStatus": "unscored_no_self_split_permission", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_376f33db229a46b7", "label": "DailyMed（NLM）：盐酸肼屈嗪普通片 10／25／50／100 mg 当前美国通用药标签、十二个瓶装 NDC 与四个准确包装面板（ANDA 200770；2026 年标签）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b3d1786d-c3ff-42f1-a09f-37a9c9021e5a", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-generic-hydralazine-ir-50mg-100-tablet-bottle-ndc-6438073506", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国通用药标签（2026）", "en": "Current U.S. DailyMed generic label (2026)" }, "dosageForm": { "zh": "盐酸肼屈嗪普通口服片", "en": "hydralazine hydrochloride immediate-release oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 64380-735-06", "pouchCode": null, "applicationNumber": "ANDA 200770", "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片盐酸肼屈嗪 50 mg；100 片瓶装", "en": "50 mg hydralazine hydrochloride per tablet; 100-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=198e8715-f4c9-4b66-9e8e-61edab911f51-04.jpg&setid=b3d1786d-c3ff-42f1-a09f-37a9c9021e5a&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "盐酸肼屈嗪", "en": "hydralazine hydrochloride" }, "value": 50, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、频次、递增步骤、目标血压，也不是与 APRESOLINE 注射剂、BIDIL 或另一种降压药的换算值", "en": "labelled amount per tablet; not an individual's tablet count, frequency, titration step, target blood pressure or conversion to APRESOLINE injection, BIDIL or another antihypertensive" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-02", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "current_regulatory_listing_not_live_stock", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "橙色", "en": "orange" }, "shape": { "zh": "圆形、平面斜边普通片", "en": "round, flat bevel-edged immediate-release tablet" }, "imprint": "50", "scoreStatus": "unscored_no_self_split_permission", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_376f33db229a46b7", "label": "DailyMed（NLM）：盐酸肼屈嗪普通片 10／25／50／100 mg 当前美国通用药标签、十二个瓶装 NDC 与四个准确包装面板（ANDA 200770；2026 年标签）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b3d1786d-c3ff-42f1-a09f-37a9c9021e5a", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-generic-hydralazine-ir-50mg-500-tablet-bottle-ndc-6438073507", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国通用药标签（2026）", "en": "Current U.S. DailyMed generic label (2026)" }, "dosageForm": { "zh": "盐酸肼屈嗪普通口服片", "en": "hydralazine hydrochloride immediate-release oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 64380-735-07", "pouchCode": null, "applicationNumber": "ANDA 200770", "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片盐酸肼屈嗪 50 mg；500 片瓶装", "en": "50 mg hydralazine hydrochloride per tablet; 500-tablet bottle" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "盐酸肼屈嗪", "en": "hydralazine hydrochloride" }, "value": 50, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、频次、递增步骤、目标血压，也不是与 APRESOLINE 注射剂、BIDIL 或另一种降压药的换算值", "en": "labelled amount per tablet; not an individual's tablet count, frequency, titration step, target blood pressure or conversion to APRESOLINE injection, BIDIL or another antihypertensive" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 500, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-02", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "current_regulatory_listing_not_live_stock", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 500, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "橙色", "en": "orange" }, "shape": { "zh": "圆形、平面斜边普通片", "en": "round, flat bevel-edged immediate-release tablet" }, "imprint": "50", "scoreStatus": "unscored_no_self_split_permission", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_376f33db229a46b7", "label": "DailyMed（NLM）：盐酸肼屈嗪普通片 10／25／50／100 mg 当前美国通用药标签、十二个瓶装 NDC 与四个准确包装面板（ANDA 200770；2026 年标签）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b3d1786d-c3ff-42f1-a09f-37a9c9021e5a", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-generic-hydralazine-ir-50mg-1000-tablet-bottle-ndc-6438073508", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国通用药标签（2026）", "en": "Current U.S. DailyMed generic label (2026)" }, "dosageForm": { "zh": "盐酸肼屈嗪普通口服片", "en": "hydralazine hydrochloride immediate-release oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 64380-735-08", "pouchCode": null, "applicationNumber": "ANDA 200770", "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片盐酸肼屈嗪 50 mg；1000 片瓶装", "en": "50 mg hydralazine hydrochloride per tablet; 1000-tablet bottle" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "盐酸肼屈嗪", "en": "hydralazine hydrochloride" }, "value": 50, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、频次、递增步骤、目标血压，也不是与 APRESOLINE 注射剂、BIDIL 或另一种降压药的换算值", "en": "labelled amount per tablet; not an individual's tablet count, frequency, titration step, target blood pressure or conversion to APRESOLINE injection, BIDIL or another antihypertensive" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 1000, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-02", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "current_regulatory_listing_not_live_stock", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 1000, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "橙色", "en": "orange" }, "shape": { "zh": "圆形、平面斜边普通片", "en": "round, flat bevel-edged immediate-release tablet" }, "imprint": "50", "scoreStatus": "unscored_no_self_split_permission", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_376f33db229a46b7", "label": "DailyMed（NLM）：盐酸肼屈嗪普通片 10／25／50／100 mg 当前美国通用药标签、十二个瓶装 NDC 与四个准确包装面板（ANDA 200770；2026 年标签）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b3d1786d-c3ff-42f1-a09f-37a9c9021e5a", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-generic-hydralazine-ir-100mg-100-tablet-bottle-ndc-6438073606", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国通用药标签（2026）", "en": "Current U.S. DailyMed generic label (2026)" }, "dosageForm": { "zh": "盐酸肼屈嗪普通口服片", "en": "hydralazine hydrochloride immediate-release oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 64380-736-06", "pouchCode": null, "applicationNumber": "ANDA 200770", "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片盐酸肼屈嗪 100 mg；100 片瓶装", "en": "100 mg hydralazine hydrochloride per tablet; 100-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=198e8715-f4c9-4b66-9e8e-61edab911f51-05.jpg&setid=b3d1786d-c3ff-42f1-a09f-37a9c9021e5a&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "盐酸肼屈嗪", "en": "hydralazine hydrochloride" }, "value": 100, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、频次、递增步骤、目标血压，也不是与 APRESOLINE 注射剂、BIDIL 或另一种降压药的换算值", "en": "labelled amount per tablet; not an individual's tablet count, frequency, titration step, target blood pressure or conversion to APRESOLINE injection, BIDIL or another antihypertensive" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-02", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "current_regulatory_listing_not_live_stock", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "橙色", "en": "orange" }, "shape": { "zh": "圆形、平面斜边普通片", "en": "round, flat bevel-edged immediate-release tablet" }, "imprint": "100", "scoreStatus": "unscored_no_self_split_permission", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_376f33db229a46b7", "label": "DailyMed（NLM）：盐酸肼屈嗪普通片 10／25／50／100 mg 当前美国通用药标签、十二个瓶装 NDC 与四个准确包装面板（ANDA 200770；2026 年标签）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b3d1786d-c3ff-42f1-a09f-37a9c9021e5a", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-generic-hydralazine-ir-100mg-500-tablet-bottle-ndc-6438073607", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国通用药标签（2026）", "en": "Current U.S. DailyMed generic label (2026)" }, "dosageForm": { "zh": "盐酸肼屈嗪普通口服片", "en": "hydralazine hydrochloride immediate-release oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 64380-736-07", "pouchCode": null, "applicationNumber": "ANDA 200770", "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片盐酸肼屈嗪 100 mg；500 片瓶装", "en": "100 mg hydralazine hydrochloride per tablet; 500-tablet bottle" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "盐酸肼屈嗪", "en": "hydralazine hydrochloride" }, "value": 100, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、频次、递增步骤、目标血压，也不是与 APRESOLINE 注射剂、BIDIL 或另一种降压药的换算值", "en": "labelled amount per tablet; not an individual's tablet count, frequency, titration step, target blood pressure or conversion to APRESOLINE injection, BIDIL or another antihypertensive" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 500, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-02", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "current_regulatory_listing_not_live_stock", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 500, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "橙色", "en": "orange" }, "shape": { "zh": "圆形、平面斜边普通片", "en": "round, flat bevel-edged immediate-release tablet" }, "imprint": "100", "scoreStatus": "unscored_no_self_split_permission", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_376f33db229a46b7", "label": "DailyMed（NLM）：盐酸肼屈嗪普通片 10／25／50／100 mg 当前美国通用药标签、十二个瓶装 NDC 与四个准确包装面板（ANDA 200770；2026 年标签）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b3d1786d-c3ff-42f1-a09f-37a9c9021e5a", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-generic-hydralazine-ir-100mg-1000-tablet-bottle-ndc-6438073608", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国通用药标签（2026）", "en": "Current U.S. DailyMed generic label (2026)" }, "dosageForm": { "zh": "盐酸肼屈嗪普通口服片", "en": "hydralazine hydrochloride immediate-release oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 64380-736-08", "pouchCode": null, "applicationNumber": "ANDA 200770", "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片盐酸肼屈嗪 100 mg；1000 片瓶装", "en": "100 mg hydralazine hydrochloride per tablet; 1000-tablet bottle" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "盐酸肼屈嗪", "en": "hydralazine hydrochloride" }, "value": 100, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、频次、递增步骤、目标血压，也不是与 APRESOLINE 注射剂、BIDIL 或另一种降压药的换算值", "en": "labelled amount per tablet; not an individual's tablet count, frequency, titration step, target blood pressure or conversion to APRESOLINE injection, BIDIL or another antihypertensive" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 1000, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-02", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "current_regulatory_listing_not_live_stock", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 1000, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "橙色", "en": "orange" }, "shape": { "zh": "圆形、平面斜边普通片", "en": "round, flat bevel-edged immediate-release tablet" }, "imprint": "100", "scoreStatus": "unscored_no_self_split_permission", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_376f33db229a46b7", "label": "DailyMed（NLM）：盐酸肼屈嗪普通片 10／25／50／100 mg 当前美国通用药标签、十二个瓶装 NDC 与四个准确包装面板（ANDA 200770；2026 年标签）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b3d1786d-c3ff-42f1-a09f-37a9c9021e5a", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-generic-hydralazine-ir-25mg-100-tablet-bottle-ndc-6438073406", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=198e8715-f4c9-4b66-9e8e-61edab911f51-02.jpg&setid=b3d1786d-c3ff-42f1-a09f-37a9c9021e5a&type=img", "alt": "Strides 盐酸肼屈嗪 25 mg、NDC 64380-734-06、100 片瓶装的 DailyMed 官方通用药标签面板", "archiveMarket": "美国", "labelVersion": "DailyMed 当前美国通用药标签（2026）", "presentation": "25 mg：橙色圆形、平面斜边、无刻痕、印有 25；NDC 64380-734-06，100 片瓶装。", "notice": "此图是当前通用药包装标签，不是 APRESOLINE 历史原品牌包装；只对应 NDC 64380-734-06，不代表 10/50/100 mg、其他瓶数、注射剂、BIDIL、其他厂商或其他市场，也不用于鉴定真伪。", "source": { "id": "src_376f33db229a46b7", "label": "DailyMed（NLM）：盐酸肼屈嗪普通片 10／25／50／100 mg 当前美国通用药标签、十二个瓶装 NDC 与四个准确包装面板（ANDA 200770；2026 年标签）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b3d1786d-c3ff-42f1-a09f-37a9c9021e5a", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "盐酸肼屈嗪说明书放大阅读：每片 mg、整瓶片数、站立性低血压、胸痛与狼疮样反应", "en": "Hydralazine enlarged label: per-tablet mg, bottle count, orthostatic hypotension, chest pain and lupus-like reactions" }, "summary": { "zh": "10、25、50、100 mg 是每片含量；100、500、1000 Tablets 是整瓶片数。当前标签描述这些片剂均无刻痕，不能从算术或外观生成掰片许可。网页也不把专业说明书中的剂量调整段落转换为个人频次、片数、递增或漏服方案。", "en": "The 10, 25, 50 and 100 mg figures are amounts per tablet; 100, 500 and 1000 Tablets are bottle counts. The current label describes these tablets as unscored, so arithmetic or appearance cannot create permission to split. The site also does not turn professional dose-adjustment text into an individual's frequency, tablet count, titration or missed-dose plan." }, "checks": [ { "zh": "头晕、站起时眼前发黑、明显乏力、心悸或晕厥可能伴随血压过低；老人、跌倒风险高或同时使用其他降压药者应及时核对完整药单。严重晕厥、受伤或意识异常应使用当地急救。", "en": "Dizziness, darkening vision on standing, marked weakness, palpitations or syncope may accompany low blood pressure. Older adults, people at higher fall risk or those using other antihypertensives require timely review of the complete medicine list. Severe syncope, injury or altered awareness needs local emergency care." }, { "zh": "肼屈嗪可引起心肌刺激、心动过速和心绞痛；说明书指出其与心肌缺血有关并曾被牵涉于心肌梗死。新发或加重胸痛、明显气促、冷汗或放射痛不能等待网页，应立即使用当地急救渠道。", "en": "Hydralazine can cause myocardial stimulation, tachycardia and angina; the label links it to myocardial ischaemia and notes implication in myocardial infarction. New or worsening chest pain, marked breathlessness, cold sweat or radiating pain must not wait for a webpage and requires local emergency care." }, { "zh": "长期治疗可能出现类似系统性红斑狼疮的表现，包括肾小球肾炎。关节痛、发热、胸痛、明显不适、皮疹或尿液/肾脏异常应联系治疗团队；说明书所述定期全血细胞计数和抗核抗体检查由负责团队安排，网页不自行开检查。", "en": "Longer treatment can cause a syndrome resembling systemic lupus erythematosus, including glomerulonephritis. Joint pain, fever, chest pain, marked malaise, rash or urinary/kidney changes need treating-team review. Periodic complete blood count and antinuclear antibody testing described by the label belongs to the responsible team; the site does not order tests." }, { "zh": "麻木、刺痛或灼痛可能提示周围神经炎；标签还列出血红蛋白和红细胞减少、白细胞减少、粒细胞缺乏或紫癜等血液异常。出现进行性神经症状、发热咽痛、异常出血或瘀斑应及时就医。", "en": "Numbness, tingling or burning can suggest peripheral neuritis. The label also lists reduced haemoglobin/red cells, leucopenia, agranulocytosis or purpura. Progressive neurological symptoms, fever/sore throat, unusual bleeding or bruising needs prompt medical review." }, { "zh": "应把全部降压药、利尿剂、β 受体阻滞剂、硝酸酯、BIDIL、PDE-5 抑制剂以及单胺氧化酶抑制剂等完整药单交给医生或药师核对。不要自行叠加、错开、停掉一盒或按一次血压读数改变用法。", "en": "Give the doctor or pharmacist the complete list, including other antihypertensives, diuretics, beta blockers, nitrates, BIDIL, PDE-5 inhibitors and monoamine oxidase inhibitors. Do not self-combine, space, remove a pack or change use from one blood-pressure reading." } ], "source": { "id": "src_376f33db229a46b7", "label": "DailyMed（NLM）：盐酸肼屈嗪普通片 10／25／50／100 mg 当前美国通用药标签、十二个瓶装 NDC 与四个准确包装面板（ANDA 200770；2026 年标签）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b3d1786d-c3ff-42f1-a09f-37a9c9021e5a", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "肼屈嗪怎样影响血压：直接放松血管平滑肌，但身体会出现反射性反应", "en": "How hydralazine affects blood pressure: direct vascular smooth-muscle relaxation with reflex responses" }, "summary": { "zh": "当前标签说明肼屈嗪直接作用于血管平滑肌，使外周血管舒张并降低外周阻力；同时可能增加心率、心输出量、肾素和醛固酮。完整分子机制并未因此被简化成一个开关，也不能从机制预测个人血压、脉搏、疗效或风险。", "en": "The current label says hydralazine acts directly on vascular smooth muscle, producing peripheral vasodilation and reduced peripheral resistance. Heart rate, cardiac output, renin and aldosterone may also increase. This does not reduce the full molecular mechanism to one switch or predict an individual's pressure, pulse, benefit or risk." }, "checks": [ { "zh": "“扩张血管”不代表可与硝酸异山梨酯、BIDIL、硝酸甘油、钙通道阻滞剂或其他降压药按 mg 自行拼接；共同降压用途可能叠加低血压、心率和跌倒风险。", "en": "Vasodilation does not permit self-assembling hydralazine with isosorbide dinitrate, BIDIL, nitroglycerin, a calcium-channel blocker or another antihypertensive by milligrams. A shared blood-pressure role may add hypotension, heart-rate and fall risks." }, { "zh": "肼屈嗪存在乙酰化多态性，慢乙酰化者可能有较高药物水平；这解释部分个体差异，但不是网页默认推荐全基因组筛查、基因分型或自行调药的理由。", "en": "Hydralazine has polymorphic acetylation, and slow acetylators may have higher drug levels. This explains some variability but is not a default reason for the site to recommend whole-genome screening, genotype testing or self-adjustment." }, { "zh": "同样的每片 mg 在疾病、年龄、肝肾状况、血压、脉搏和并用药不同的人身上意义不同。网页只帮助识别准确产品与说明书边界，不计算个人目标血压、等效剂量或递增速度。", "en": "The same per-tablet milligram figure has different context across disease, age, liver/kidney status, pressure, pulse and co-medication. The site identifies the exact product and label boundary and does not calculate an individual target pressure, equivalent dose or titration speed." } ], "source": { "id": "src_376f33db229a46b7", "label": "DailyMed（NLM）：盐酸肼屈嗪普通片 10／25／50／100 mg 当前美国通用药标签、十二个瓶装 NDC 与四个准确包装面板（ANDA 200770；2026 年标签）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b3d1786d-c3ff-42f1-a09f-37a9c9021e5a", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "APRESOLINE / hydralazine", "generic": "盐酸肼屈嗪普通片", "dosageFormClass": "盐酸肼屈嗪普通口服片；不并入本页口服片身份的产品包括 20 mg/mL 注射剂、BIDIL 硝酸异山梨酯/盐酸肼屈嗪固定复方及其他降压药。APRESOLINE 历史原研与当前通用药也必须分开；共同成分、用途或 mg 数字不建立换算、片数、频次、递增、分片或替换结论。" }, "labelSource": { "id": "src_376f33db229a46b7", "label": "DailyMed（NLM）：盐酸肼屈嗪普通片 10／25／50／100 mg 当前美国通用药标签、十二个瓶装 NDC 与四个准确包装面板（ANDA 200770；2026 年标签）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b3d1786d-c3ff-42f1-a09f-37a9c9021e5a", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, "productRoutes": [ { "source": { "id": "src_376f33db229a46b7", "label": "DailyMed（NLM）：盐酸肼屈嗪普通片 10／25／50／100 mg 当前美国通用药标签、十二个瓶装 NDC 与四个准确包装面板（ANDA 200770；2026 年标签）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b3d1786d-c3ff-42f1-a09f-37a9c9021e5a", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-09-02", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_58616678e6f146bc", "label": "FDA Drugs@FDA：APRESOLINE／hydralazine hydrochloride NDA 008303 的 1953 年初始批准、四个口服片历史 RLD 与 DISCN 状态", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=008303", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-09-02", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_57c7bee7f33ae3fb", "label": "FDA：APRESOLINE（hydralazine hydrochloride）NDA 008303 历史口服片标签（1996 年版本）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/1996/008303s068lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_regulatory_document", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-09-02", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-09-02", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "APRESOLINE 是盐酸肼屈嗪普通片的美国历史原研/RLD；本页可见包装是当前通用药，不是原品牌。10/25/50/100 mg 是每片含量，100/500/1000 Tablets 是整瓶片数。说明书重点涉及血压过低、眩晕/晕厥与跌倒、心跳加快和心绞痛/胸痛、狼疮样综合征、麻木刺痛及血细胞变化。网页不生成个人频次、片数、递增计划或停换药指令。", "history": "FDA 记录 APRESOLINE 于 1953 年在美国初始批准。当前四个口服历史 RLD 规格均为 DISCN，且不是因安全性或有效性撤回。DailyMed 当前页面则展示 ANDA 200770 的十二个通用药瓶装身份。APRESOLINE 20 mg/mL 注射剂与口服片是不同剂型，BIDIL 还含硝酸异山梨酯，均不得借共同成分混入本页口服片身份。", "sourceDocuments": [ { "id": "src_376f33db229a46b7", "label": "DailyMed（NLM）：盐酸肼屈嗪普通片 10／25／50／100 mg 当前美国通用药标签、十二个瓶装 NDC 与四个准确包装面板（ANDA 200770；2026 年标签）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b3d1786d-c3ff-42f1-a09f-37a9c9021e5a", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, { "id": "src_58616678e6f146bc", "label": "FDA Drugs@FDA：APRESOLINE／hydralazine hydrochloride NDA 008303 的 1953 年初始批准、四个口服片历史 RLD 与 DISCN 状态", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=008303", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, { "id": "src_57c7bee7f33ae3fb", "label": "FDA：APRESOLINE（hydralazine hydrochloride）NDA 008303 历史口服片标签（1996 年版本）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/1996/008303s068lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_regulatory_document", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" } ], "applicationNumber": "APRESOLINE NDA 008303（历史原研/RLD）；hydralazine hydrochloride ANDA 200770（当前通用药标签）", "approvalTimeline": [ { "date": "1953-01-15", "title": { "zh": "APRESOLINE 在美国初始批准", "en": "Initial U.S. approval of APRESOLINE" }, "detail": { "zh": "FDA Drugs@FDA 将 NDA 008303 记录为 1953 年初始批准的优先审评新分子实体。", "en": "FDA Drugs@FDA records NDA 008303 as a priority-reviewed new molecular entity initially approved in 1953." }, "source": { "id": "src_58616678e6f146bc", "label": "FDA Drugs@FDA：APRESOLINE／hydralazine hydrochloride NDA 008303 的 1953 年初始批准、四个口服片历史 RLD 与 DISCN 状态", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=008303", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" } }, { "date": "1996", "title": { "zh": "FDA 历史口服片标签版本", "en": "Historical FDA oral-tablet label version" }, "detail": { "zh": "FDA 公开保存 NDA 008303 的 1996 年 APRESOLINE 口服片标签；它用于历史追溯，不冒充当前品牌供应。", "en": "FDA publicly preserves a 1996 APRESOLINE oral-tablet label under NDA 008303. It supports history and is not presented as current brand supply." }, "source": { "id": "src_57c7bee7f33ae3fb", "label": "FDA：APRESOLINE（hydralazine hydrochloride）NDA 008303 历史口服片标签（1996 年版本）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/1996/008303s068lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_regulatory_document", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" } }, { "date": "2026-09-02", "title": { "zh": "当前原研状态与通用药包装核验", "en": "Current originator status and generic-pack verification" }, "detail": { "zh": "四个 APRESOLINE 口服 RLD 规格均为 DISCN 且非因安全性或有效性撤回；ANDA 200770 当前标签列出十二个通用药瓶装 NDC。", "en": "All four APRESOLINE oral RLD strengths are DISCN and not withdrawn for safety or effectiveness. The current ANDA 200770 label lists twelve generic bottle NDCs." }, "source": { "id": "src_58616678e6f146bc", "label": "FDA Drugs@FDA：APRESOLINE／hydralazine hydrochloride NDA 008303 的 1953 年初始批准、四个口服片历史 RLD 与 DISCN 状态", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=008303", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" } } ], "marketStatus": [ { "market": { "zh": "美国 APRESOLINE 口服片", "en": "United States — APRESOLINE oral tablets" }, "status": { "zh": "历史原研/RLD，已停市", "en": "Historical originator/RLD; discontinued" }, "detail": { "zh": "NDA 008303；10、25、50、100 mg 当前均为 DISCN，且并非因安全性或有效性撤回。", "en": "NDA 008303; the 10, 25, 50 and 100 mg rows are DISCN and not withdrawn for safety or effectiveness." } }, { "market": { "zh": "美国当前通用药", "en": "United States — current generic" }, "status": { "zh": "当前公开通用药标签", "en": "Current public generic label" }, "detail": { "zh": "ANDA 200770；10、25、50、100 mg，各有 100、500、1000 片瓶装。", "en": "ANDA 200770; 10, 25, 50 and 100 mg, each in 100-, 500- and 1000-tablet bottles." } }, { "market": { "zh": "注射剂与 BIDIL", "en": "Injection and BIDIL" }, "status": { "zh": "不同剂型或固定复方", "en": "Separate dosage form or fixed combination" }, "detail": { "zh": "APRESOLINE 20 mg/mL 注射剂不是口服片；BIDIL 另含硝酸异山梨酯，不能按共同肼屈嗪成分并入本档案包装。", "en": "APRESOLINE 20 mg/mL injection is not an oral tablet. BIDIL additionally contains isosorbide dinitrate and cannot be merged into these packs from a shared hydralazine ingredient." } }, { "market": { "zh": "美国以外市场", "en": "Markets outside the United States" }, "status": { "zh": "本档案未确认当地品牌、规格、包装或供应", "en": "Local brand, strength, pack and supply are not established" }, "detail": { "zh": "必须按当地药监记录、现行说明书和手中药盒逐项核对。", "en": "Check the local regulator, current label and pack in hand item by item." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "照片里的是 APRESOLINE 原研药瓶吗？", "en": "Is the pictured bottle the original APRESOLINE product?" }, "answer": { "zh": "不是。图片是 Strides ANDA 200770 当前通用药包装面板；APRESOLINE 只作为历史原研/RLD 身份展示，本页没有把通用药图片冒充原品牌。", "en": "No. The image is a current Strides generic package panel under ANDA 200770. APRESOLINE is shown only as the historical originator/RLD identity, and no generic image is presented as the original brand." } }, { "question": { "zh": "1000 Tablets 是一次要吃 1000 片吗？", "en": "Does 1000 Tablets mean taking 1000 tablets at once?" }, "answer": { "zh": "不是。1000 Tablets 是整瓶片数；10/25/50/100 mg 才是每片标签含量。网页不根据瓶数或 mg 生成个人片数、频次或递增方案。", "en": "No. 1000 Tablets is the bottle count; 10/25/50/100 mg is the labelled amount per tablet. The site does not use a bottle count or milligrams to generate an individual tablet count, frequency or titration plan." } }, { "question": { "zh": "100 mg 可以掰成两片 50 mg 吗？", "en": "Can a 100 mg tablet be split into two 50 mg halves?" }, "answer": { "zh": "不能由算术自行决定。当前标签描述这些片剂无刻痕，100 mg 与 50 mg 还是不同准确产品；分片必须核对具体处方、厂家现行标签和药师意见。", "en": "Not from arithmetic alone. The current label describes these tablets as unscored, and 100 mg and 50 mg remain separate exact products. Splitting requires the exact prescription, current manufacturer label and pharmacist review." } }, { "question": { "zh": "APRESOLINE、BIDIL 和 ISORDIL 是同一种药吗？", "en": "Are APRESOLINE, BIDIL and ISORDIL the same medicine?" }, "answer": { "zh": "不是。APRESOLINE 是肼屈嗪历史品牌；BIDIL 是硝酸异山梨酯/盐酸肼屈嗪固定复方；ISORDIL 是硝酸异山梨酯产品。共同心血管用途不建立替换或叠加许可。", "en": "No. APRESOLINE is the historical hydralazine brand; BIDIL is a fixed isosorbide dinitrate/hydralazine hydrochloride combination; ISORDIL is an isosorbide dinitrate product. A shared cardiovascular role does not permit substitution or combination." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "dose-unit-literacy", "same-class-is-not-same-medicine", "interactions-are-not-a-home-scheduling-problem" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/apresoline-hydralazine/", "en": "https://origindrug.com/en/drugs/apresoline-hydralazine/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "catapres-clonidine-oral", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-09-02", "status": "published_traceable_archive" }, "names": { "brand": "CATAPRES / clonidine oral", "generic": "盐酸可乐定普通片", "aliases": [ "CATAPRES", "Catapres", "clonidine", "clonidine hydrochloride", "clonidine tablets", "可乐定", "盐酸可乐定", "盐酸可乐定片", "可乐定片", "NDA 017407", "ANDA 070923", "52817-183-10", "52817-180-10", "52817-180-50", "52817-180-00", "52817-181-10", "52817-181-50", "52817-181-00", "52817-182-10", "52817-182-50", "52817-182-00", "MP 657", "MP 658", "MP 659" ], "marketBrandNames": [ { "name": "CATAPRES", "market": { "zh": "美国", "en": "United States" }, "evidenceStatus": "historical_regulatory_record", "note": { "zh": "NDA 017407 历史原研/RLD；0.1、0.2、0.3 mg 口服普通片当前均列 DISCN，并注明并非因安全性或有效性撤回。本页不展示历史原品牌包装。", "en": "Historical originator/RLD under NDA 017407. The 0.1, 0.2 and 0.3 mg immediate-release oral tablets are DISCN and marked as not withdrawn for safety or effectiveness. This page does not display a historical original-brand pack." }, "source": { "id": "src_bbd63a95cbbe6561", "label": "FDA：CATAPRES 口服普通片 NDA 017407 的 1974 年批准、RLD 与剂型历史（NDA 022331 审评）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022331s000_ChemR.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_regulatory_document", "documentKind": "regulatory_review", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" } }, { "name": "clonidine hydrochloride tablets", "market": { "zh": "美国", "en": "United States" }, "evidenceStatus": "current_regulatory_record", "note": { "zh": "TruPharma ANDA 070923 当前通用药标签；0.05 mg 一个瓶装，0.1/0.2/0.3 mg 各三个瓶装。监管标签不等于实时库存。", "en": "Current TruPharma generic label under ANDA 070923: one 0.05 mg bottle and three bottle counts each for 0.1, 0.2 and 0.3 mg. A regulatory label is not live stock." }, "source": { "id": "src_469743acbb6b2000", "label": "DailyMed（NLM）：盐酸可乐定普通片 0.05／0.1／0.2／0.3 mg 当前美国通用药标签、十个瓶装 NDC 与六个准确包装面板（ANDA 070923；2026-04）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c83e4e4f-bd0e-449d-958a-dc0d570a01ba", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" } } ], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "心血管", "sourceArchiveMarket": "FDA 历史记录把 CATAPRES NDA 017407 的 0.1、0.2、0.3 mg 口服普通片列为历史 RLD、当前 DISCN，并标注并非因安全性或有效性撤回。当前准确包装来自 TruPharma ANDA 070923 通用药标签：0.05 mg 一个瓶装，0.1、0.2、0.3 mg 各三个瓶装，共十个 NDC；六个有准确公开包装面板。历史品牌、当前通用药与其他可乐定剂型不得混写。", "dosageFormClass": "盐酸可乐定普通口服片；不并入本档案包装身份的产品包括 CATAPRES-TTS 经皮给药系统、DURACLON 注射剂、KAPVAY/JENLOGA/NEXICLON XR 缓释制剂、JAVADIN 口服液、COMBIPRES 固定复方及其他含可乐定产品。共同通用名或 mg 数字不建立剂型换算、频次、减量、分片或替换结论。", "dosageFormClassCode": "oral_modified_release", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "1974（CATAPRES 美国口服普通片初始批准年份）", "archiveSponsorText": "CATAPRES 历史原研/RLD（Boehringer Ingelheim）；TruPharma, LLC 为当前展示通用药标签方" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [ "CATAPRES", "clonidine", "clonidine hydrochloride", "clonidine tablets", "可乐定", "盐酸可乐定", "盐酸可乐定片", "可乐定片" ], "excludedProductCues": [ "CATAPRES-TTS", "clonidine transdermal", "clonidine patch", "DURACLON", "clonidine injection", "KAPVAY", "JENLOGA", "NEXICLON XR", "JAVADIN", "COMBIPRES", "chlorthalidone and clonidine", "可乐定贴", "可乐定注射液", "可乐定缓释片", "可乐定口服液" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-generic-clonidine-ir-0-05mg-100-tablet-bottle-ndc-5281718310", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国通用药标签（SPL v11；2026-04-30 生效）", "en": "Current U.S. DailyMed generic label (SPL v11; effective 30 Apr 2026)" }, "dosageForm": { "zh": "盐酸可乐定普通口服片", "en": "clonidine hydrochloride immediate-release oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 52817-183-10", "pouchCode": null, "applicationNumber": "ANDA 070923", "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片盐酸可乐定 0.05 mg；100 片瓶装", "en": "0.05 mg clonidine hydrochloride per tablet; 100-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=0-0-5mg-label.jpg&setid=c83e4e4f-bd0e-449d-958a-dc0d570a01ba&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "盐酸可乐定", "en": "clonidine hydrochloride" }, "value": 0.05, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、频次、减量步骤，也不是与 CATAPRES-TTS 贴剂、缓释片、口服液、注射剂或复方片的换算值", "en": "labelled amount per tablet; not an individual's tablet count, frequency, taper step or conversion to a CATAPRES-TTS patch, extended-release tablet, oral solution, injection or combination tablet" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-02", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "current_regulatory_listing_not_live_stock", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "黄色", "en": "yellow" }, "shape": { "zh": "椭圆形普通片", "en": "oval immediate-release tablet" }, "imprint": "05", "scoreStatus": "single_score_appearance_clue_not_self_split_permission", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_469743acbb6b2000", "label": "DailyMed（NLM）：盐酸可乐定普通片 0.05／0.1／0.2／0.3 mg 当前美国通用药标签、十个瓶装 NDC 与六个准确包装面板（ANDA 070923；2026-04）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c83e4e4f-bd0e-449d-958a-dc0d570a01ba", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-generic-clonidine-ir-0-1mg-100-tablet-bottle-ndc-5281718010", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国通用药标签（SPL v11；2026-04-30 生效）", "en": "Current U.S. DailyMed generic label (SPL v11; effective 30 Apr 2026)" }, "dosageForm": { "zh": "盐酸可乐定普通口服片", "en": "clonidine hydrochloride immediate-release oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 52817-180-10", "pouchCode": null, "applicationNumber": "ANDA 070923", "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片盐酸可乐定 0.1 mg；100 片瓶装", "en": "0.1 mg clonidine hydrochloride per tablet; 100-tablet bottle" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "盐酸可乐定", "en": "clonidine hydrochloride" }, "value": 0.1, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、频次、减量步骤，也不是与 CATAPRES-TTS 贴剂、缓释片、口服液、注射剂或复方片的换算值", "en": "labelled amount per tablet; not an individual's tablet count, frequency, taper step or conversion to a CATAPRES-TTS patch, extended-release tablet, oral solution, injection or combination tablet" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-02", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "current_regulatory_listing_not_live_stock", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "黄色", "en": "yellow" }, "shape": { "zh": "圆形普通片", "en": "round immediate-release tablet" }, "imprint": "MP;657", "scoreStatus": "single_score_appearance_clue_not_self_split_permission", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_469743acbb6b2000", "label": "DailyMed（NLM）：盐酸可乐定普通片 0.05／0.1／0.2／0.3 mg 当前美国通用药标签、十个瓶装 NDC 与六个准确包装面板（ANDA 070923；2026-04）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c83e4e4f-bd0e-449d-958a-dc0d570a01ba", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-generic-clonidine-ir-0-1mg-500-tablet-bottle-ndc-5281718050", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国通用药标签（SPL v11；2026-04-30 生效）", "en": "Current U.S. DailyMed generic label (SPL v11; effective 30 Apr 2026)" }, "dosageForm": { "zh": "盐酸可乐定普通口服片", "en": "clonidine hydrochloride immediate-release oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 52817-180-50", "pouchCode": null, "applicationNumber": "ANDA 070923", "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片盐酸可乐定 0.1 mg；500 片瓶装", "en": "0.1 mg clonidine hydrochloride per tablet; 500-tablet bottle" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "盐酸可乐定", "en": "clonidine hydrochloride" }, "value": 0.1, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、频次、减量步骤，也不是与 CATAPRES-TTS 贴剂、缓释片、口服液、注射剂或复方片的换算值", "en": "labelled amount per tablet; not an individual's tablet count, frequency, taper step or conversion to a CATAPRES-TTS patch, extended-release tablet, oral solution, injection or combination tablet" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 500, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-02", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "current_regulatory_listing_not_live_stock", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 500, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "黄色", "en": "yellow" }, "shape": { "zh": "圆形普通片", "en": "round immediate-release tablet" }, "imprint": "MP;657", "scoreStatus": "single_score_appearance_clue_not_self_split_permission", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_469743acbb6b2000", "label": "DailyMed（NLM）：盐酸可乐定普通片 0.05／0.1／0.2／0.3 mg 当前美国通用药标签、十个瓶装 NDC 与六个准确包装面板（ANDA 070923；2026-04）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c83e4e4f-bd0e-449d-958a-dc0d570a01ba", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-generic-clonidine-ir-0-1mg-1000-tablet-bottle-ndc-5281718000", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国通用药标签（SPL v11；2026-04-30 生效）", "en": "Current U.S. DailyMed generic label (SPL v11; effective 30 Apr 2026)" }, "dosageForm": { "zh": "盐酸可乐定普通口服片", "en": "clonidine hydrochloride immediate-release oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 52817-180-00", "pouchCode": null, "applicationNumber": "ANDA 070923", "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片盐酸可乐定 0.1 mg；1000 片瓶装", "en": "0.1 mg clonidine hydrochloride per tablet; 1000-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=clonidine-hydrochloride-03.jpg&setid=c83e4e4f-bd0e-449d-958a-dc0d570a01ba&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "盐酸可乐定", "en": "clonidine hydrochloride" }, "value": 0.1, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、频次、减量步骤，也不是与 CATAPRES-TTS 贴剂、缓释片、口服液、注射剂或复方片的换算值", "en": "labelled amount per tablet; not an individual's tablet count, frequency, taper step or conversion to a CATAPRES-TTS patch, extended-release tablet, oral solution, injection or combination tablet" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 1000, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-02", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "current_regulatory_listing_not_live_stock", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 1000, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "黄色", "en": "yellow" }, "shape": { "zh": "圆形普通片", "en": "round immediate-release tablet" }, "imprint": "MP;657", "scoreStatus": "single_score_appearance_clue_not_self_split_permission", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_469743acbb6b2000", "label": "DailyMed（NLM）：盐酸可乐定普通片 0.05／0.1／0.2／0.3 mg 当前美国通用药标签、十个瓶装 NDC 与六个准确包装面板（ANDA 070923；2026-04）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c83e4e4f-bd0e-449d-958a-dc0d570a01ba", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-generic-clonidine-ir-0-2mg-100-tablet-bottle-ndc-5281718110", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国通用药标签（SPL v11；2026-04-30 生效）", "en": "Current U.S. DailyMed generic label (SPL v11; effective 30 Apr 2026)" }, "dosageForm": { "zh": "盐酸可乐定普通口服片", "en": "clonidine hydrochloride immediate-release oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 52817-181-10", "pouchCode": null, "applicationNumber": "ANDA 070923", "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片盐酸可乐定 0.2 mg；100 片瓶装", "en": "0.2 mg clonidine hydrochloride per tablet; 100-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=clonidine-hydrochloride-04.jpg&setid=c83e4e4f-bd0e-449d-958a-dc0d570a01ba&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "盐酸可乐定", "en": "clonidine hydrochloride" }, "value": 0.2, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、频次、减量步骤，也不是与 CATAPRES-TTS 贴剂、缓释片、口服液、注射剂或复方片的换算值", "en": "labelled amount per tablet; not an individual's tablet count, frequency, taper step or conversion to a CATAPRES-TTS patch, extended-release tablet, oral solution, injection or combination tablet" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-02", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "current_regulatory_listing_not_live_stock", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "白色", "en": "white" }, "shape": { "zh": "圆形普通片", "en": "round immediate-release tablet" }, "imprint": "MP;658", "scoreStatus": "single_score_appearance_clue_not_self_split_permission", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_469743acbb6b2000", "label": "DailyMed（NLM）：盐酸可乐定普通片 0.05／0.1／0.2／0.3 mg 当前美国通用药标签、十个瓶装 NDC 与六个准确包装面板（ANDA 070923；2026-04）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c83e4e4f-bd0e-449d-958a-dc0d570a01ba", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-generic-clonidine-ir-0-2mg-500-tablet-bottle-ndc-5281718150", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国通用药标签（SPL v11；2026-04-30 生效）", "en": "Current U.S. DailyMed generic label (SPL v11; effective 30 Apr 2026)" }, "dosageForm": { "zh": "盐酸可乐定普通口服片", "en": "clonidine hydrochloride immediate-release oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 52817-181-50", "pouchCode": null, "applicationNumber": "ANDA 070923", "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片盐酸可乐定 0.2 mg；500 片瓶装", "en": "0.2 mg clonidine hydrochloride per tablet; 500-tablet bottle" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "盐酸可乐定", "en": "clonidine hydrochloride" }, "value": 0.2, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、频次、减量步骤，也不是与 CATAPRES-TTS 贴剂、缓释片、口服液、注射剂或复方片的换算值", "en": "labelled amount per tablet; not an individual's tablet count, frequency, taper step or conversion to a CATAPRES-TTS patch, extended-release tablet, oral solution, injection or combination tablet" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 500, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-02", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "current_regulatory_listing_not_live_stock", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 500, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "白色", "en": "white" }, "shape": { "zh": "圆形普通片", "en": "round immediate-release tablet" }, "imprint": "MP;658", "scoreStatus": "single_score_appearance_clue_not_self_split_permission", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_469743acbb6b2000", "label": "DailyMed（NLM）：盐酸可乐定普通片 0.05／0.1／0.2／0.3 mg 当前美国通用药标签、十个瓶装 NDC 与六个准确包装面板（ANDA 070923；2026-04）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c83e4e4f-bd0e-449d-958a-dc0d570a01ba", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-generic-clonidine-ir-0-2mg-1000-tablet-bottle-ndc-5281718100", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国通用药标签（SPL v11；2026-04-30 生效）", "en": "Current U.S. DailyMed generic label (SPL v11; effective 30 Apr 2026)" }, "dosageForm": { "zh": "盐酸可乐定普通口服片", "en": "clonidine hydrochloride immediate-release oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 52817-181-00", "pouchCode": null, "applicationNumber": "ANDA 070923", "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片盐酸可乐定 0.2 mg；1000 片瓶装", "en": "0.2 mg clonidine hydrochloride per tablet; 1000-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=clonidine-hydrochloride-05.jpg&setid=c83e4e4f-bd0e-449d-958a-dc0d570a01ba&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "盐酸可乐定", "en": "clonidine hydrochloride" }, "value": 0.2, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、频次、减量步骤，也不是与 CATAPRES-TTS 贴剂、缓释片、口服液、注射剂或复方片的换算值", "en": "labelled amount per tablet; not an individual's tablet count, frequency, taper step or conversion to a CATAPRES-TTS patch, extended-release tablet, oral solution, injection or combination tablet" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 1000, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-02", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "current_regulatory_listing_not_live_stock", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 1000, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "白色", "en": "white" }, "shape": { "zh": "圆形普通片", "en": "round immediate-release tablet" }, "imprint": "MP;658", "scoreStatus": "single_score_appearance_clue_not_self_split_permission", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_469743acbb6b2000", "label": "DailyMed（NLM）：盐酸可乐定普通片 0.05／0.1／0.2／0.3 mg 当前美国通用药标签、十个瓶装 NDC 与六个准确包装面板（ANDA 070923；2026-04）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c83e4e4f-bd0e-449d-958a-dc0d570a01ba", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-generic-clonidine-ir-0-3mg-100-tablet-bottle-ndc-5281718210", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国通用药标签（SPL v11；2026-04-30 生效）", "en": "Current U.S. DailyMed generic label (SPL v11; effective 30 Apr 2026)" }, "dosageForm": { "zh": "盐酸可乐定普通口服片", "en": "clonidine hydrochloride immediate-release oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 52817-182-10", "pouchCode": null, "applicationNumber": "ANDA 070923", "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片盐酸可乐定 0.3 mg；100 片瓶装", "en": "0.3 mg clonidine hydrochloride per tablet; 100-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=clonidine-hydrochloride-06.jpg&setid=c83e4e4f-bd0e-449d-958a-dc0d570a01ba&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "盐酸可乐定", "en": "clonidine hydrochloride" }, "value": 0.3, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、频次、减量步骤，也不是与 CATAPRES-TTS 贴剂、缓释片、口服液、注射剂或复方片的换算值", "en": "labelled amount per tablet; not an individual's tablet count, frequency, taper step or conversion to a CATAPRES-TTS patch, extended-release tablet, oral solution, injection or combination tablet" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-02", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "current_regulatory_listing_not_live_stock", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "绿色", "en": "green" }, "shape": { "zh": "圆形普通片", "en": "round immediate-release tablet" }, "imprint": "MP;659", "scoreStatus": "single_score_appearance_clue_not_self_split_permission", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_469743acbb6b2000", "label": "DailyMed（NLM）：盐酸可乐定普通片 0.05／0.1／0.2／0.3 mg 当前美国通用药标签、十个瓶装 NDC 与六个准确包装面板（ANDA 070923；2026-04）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c83e4e4f-bd0e-449d-958a-dc0d570a01ba", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-generic-clonidine-ir-0-3mg-500-tablet-bottle-ndc-5281718250", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国通用药标签（SPL v11；2026-04-30 生效）", "en": "Current U.S. DailyMed generic label (SPL v11; effective 30 Apr 2026)" }, "dosageForm": { "zh": "盐酸可乐定普通口服片", "en": "clonidine hydrochloride immediate-release oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 52817-182-50", "pouchCode": null, "applicationNumber": "ANDA 070923", "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片盐酸可乐定 0.3 mg；500 片瓶装", "en": "0.3 mg clonidine hydrochloride per tablet; 500-tablet bottle" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "盐酸可乐定", "en": "clonidine hydrochloride" }, "value": 0.3, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、频次、减量步骤，也不是与 CATAPRES-TTS 贴剂、缓释片、口服液、注射剂或复方片的换算值", "en": "labelled amount per tablet; not an individual's tablet count, frequency, taper step or conversion to a CATAPRES-TTS patch, extended-release tablet, oral solution, injection or combination tablet" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 500, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-02", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "current_regulatory_listing_not_live_stock", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 500, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "绿色", "en": "green" }, "shape": { "zh": "圆形普通片", "en": "round immediate-release tablet" }, "imprint": "MP;659", "scoreStatus": "single_score_appearance_clue_not_self_split_permission", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_469743acbb6b2000", "label": "DailyMed（NLM）：盐酸可乐定普通片 0.05／0.1／0.2／0.3 mg 当前美国通用药标签、十个瓶装 NDC 与六个准确包装面板（ANDA 070923；2026-04）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c83e4e4f-bd0e-449d-958a-dc0d570a01ba", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-generic-clonidine-ir-0-3mg-1000-tablet-bottle-ndc-5281718200", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国通用药标签（SPL v11；2026-04-30 生效）", "en": "Current U.S. DailyMed generic label (SPL v11; effective 30 Apr 2026)" }, "dosageForm": { "zh": "盐酸可乐定普通口服片", "en": "clonidine hydrochloride immediate-release oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 52817-182-00", "pouchCode": null, "applicationNumber": "ANDA 070923", "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片盐酸可乐定 0.3 mg；1000 片瓶装", "en": "0.3 mg clonidine hydrochloride per tablet; 1000-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=clonidine-hydrochloride-07.jpg&setid=c83e4e4f-bd0e-449d-958a-dc0d570a01ba&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "盐酸可乐定", "en": "clonidine hydrochloride" }, "value": 0.3, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、频次、减量步骤，也不是与 CATAPRES-TTS 贴剂、缓释片、口服液、注射剂或复方片的换算值", "en": "labelled amount per tablet; not an individual's tablet count, frequency, taper step or conversion to a CATAPRES-TTS patch, extended-release tablet, oral solution, injection or combination tablet" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 1000, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-02", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "current_regulatory_listing_not_live_stock", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 1000, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "绿色", "en": "green" }, "shape": { "zh": "圆形普通片", "en": "round immediate-release tablet" }, "imprint": "MP;659", "scoreStatus": "single_score_appearance_clue_not_self_split_permission", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_469743acbb6b2000", "label": "DailyMed（NLM）：盐酸可乐定普通片 0.05／0.1／0.2／0.3 mg 当前美国通用药标签、十个瓶装 NDC 与六个准确包装面板（ANDA 070923；2026-04）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c83e4e4f-bd0e-449d-958a-dc0d570a01ba", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-generic-clonidine-ir-0-05mg-100-tablet-bottle-ndc-5281718310", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=0-0-5mg-label.jpg&setid=c83e4e4f-bd0e-449d-958a-dc0d570a01ba&type=img", "alt": "TruPharma 盐酸可乐定 0.05 mg、NDC 52817-183-10、100 片瓶装的 DailyMed 官方通用药标签面板", "archiveMarket": "美国", "labelVersion": "DailyMed 当前美国通用药标签（2026）", "presentation": "0.05 mg：黄色椭圆形、有刻痕、印有 05；NDC 52817-183-10，100 片瓶装。", "notice": "此图是当前通用药包装标签，不是 CATAPRES 历史原品牌包装；只对应 NDC 52817-183-10，不代表 0.1/0.2/0.3 mg、其他瓶数、贴剂、注射剂、缓释剂、口服液、复方、其他厂商或其他市场，也不用于鉴定真伪。", "source": { "id": "src_469743acbb6b2000", "label": "DailyMed（NLM）：盐酸可乐定普通片 0.05／0.1／0.2／0.3 mg 当前美国通用药标签、十个瓶装 NDC 与六个准确包装面板（ANDA 070923；2026-04）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c83e4e4f-bd0e-449d-958a-dc0d570a01ba", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "盐酸可乐定说明书放大阅读：每片 mg、整瓶片数、嗜睡跌倒与突然停用反跳", "en": "Clonidine enlarged label: per-tablet mg, bottle count, somnolence/falls and rebound after abrupt withdrawal" }, "summary": { "zh": "0.05、0.1、0.2、0.3 mg 是每片含量；100、500、1000 Tablets 是整瓶片数。当前片剂有刻痕，但刻痕只是准确产品的外观线索，不自动构成掰片许可。网页也不把专业说明书中的剂量或停用段落转换为个人频次、片数、减量步骤或漏服方案。", "en": "The 0.05, 0.1, 0.2 and 0.3 mg figures are amounts per tablet; 100, 500 and 1000 Tablets are bottle counts. The current tablets are scored, but a score is an exact-product appearance clue and does not automatically permit splitting. The site does not turn professional dose or withdrawal text into an individual's frequency, tablet count, taper steps or missed-dose plan." }, "checks": [ { "zh": "嗜睡、镇静、疲倦、头晕、口干和便秘较常见；老人、夜间起身或同时使用其他镇静/降压药者应优先核对意识、步态、站立性血压与跌倒风险。严重嗜睡、晕厥、受伤或意识异常应使用当地急救。", "en": "Somnolence, sedation, fatigue, dizziness, dry mouth and constipation are common. Older adults, night-time rising or co-use of sedating/blood-pressure medicines requires priority review of alertness, gait, orthostatic pressure and falls. Severe somnolence, fainting, injury or altered awareness needs local emergency care." }, { "zh": "心动过缓、传导异常和低血压风险需要结合脉搏、症状与完整药单核对。若药单还有 β 受体阻滞剂、地高辛、维拉帕米、地尔硫䓬或其他影响心率/血压的药，不要自行错开、加减或先停其中一种。", "en": "Bradycardia, conduction abnormalities and hypotension require review with pulse, symptoms and the complete medicine list. If a beta blocker, digoxin, verapamil, diltiazem or another heart-rate/blood-pressure medicine is also present, do not self-space, adjust or choose one to stop first." }, { "zh": "突然停止可乐定后可出现血压快速升高、头痛、紧张或激越、震颤等反跳表现，少数严重事件可危及生命；风险在较高剂量或合用 β 受体阻滞剂时更需重视。不要根据网页突然停药，也不要让网页生成减量表。", "en": "Abrupt clonidine withdrawal can cause a rapid pressure rise, headache, nervousness or agitation and tremor; rare severe events can be life-threatening. Risk needs particular attention at higher doses or with a beta blocker. Do not abruptly stop from a webpage or ask it to generate a taper schedule." }, { "zh": "发生呕吐、无法进食饮水、漏药、住院、手术或药盒用尽时，应尽快联系开方团队或药师处理连续用药问题；网页不能推算补服、替代剂型或临时方案。", "en": "Vomiting, inability to eat or drink, missed medicine, hospital admission, surgery or an empty pack requires prompt contact with the prescriber or pharmacist about continuity. The site cannot calculate catch-up use, a substitute formulation or a temporary plan." }, { "zh": "酒精、安眠药、阿片类、抗焦虑药、镇静性抗组胺药或其他中枢抑制药可能增加嗜睡和反应受损。驾驶、操作机器或夜间独行前应按标签和专业建议确认个人反应，不要用网页给出‘安全’许可。", "en": "Alcohol, sleep medicines, opioids, anxiolytics, sedating antihistamines or other CNS depressants can add somnolence and impaired reactions. Confirm individual response under the label and professional advice before driving, operating machinery or walking alone at night; the site cannot issue a 'safe' permission." } ], "source": { "id": "src_469743acbb6b2000", "label": "DailyMed（NLM）：盐酸可乐定普通片 0.05／0.1／0.2／0.3 mg 当前美国通用药标签、十个瓶装 NDC 与六个准确包装面板（ANDA 070923；2026-04）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c83e4e4f-bd0e-449d-958a-dc0d570a01ba", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "可乐定怎样影响血压：作用于脑干 α 肾上腺素能受体并降低交感神经输出", "en": "How clonidine affects blood pressure: brainstem alpha-adrenoreceptors and reduced sympathetic outflow" }, "summary": { "zh": "FDA 标签说明可乐定刺激脑干 α 肾上腺素能受体，降低中枢交感神经传出，并可降低外周阻力、心率和血压。这个机制有助理解嗜睡、低血压、心动过缓和突然停用反跳，但不能预测个人反应，也不能计算片数、频次、减量或剂型转换。", "en": "The FDA label says clonidine stimulates brainstem alpha-adrenoreceptors, reduces central sympathetic outflow, and can lower peripheral resistance, heart rate and blood pressure. This helps explain somnolence, hypotension, bradycardia and rebound after abrupt withdrawal, but cannot predict an individual's response or calculate tablet count, frequency, taper or formulation conversion." }, "checks": [ { "zh": "口服普通片、贴剂、缓释片、口服液和注射剂即使都含可乐定，也有不同释放方式、规格基础和用途；不能只按相同通用名或 mg 自行换算、拼接或替换。", "en": "Immediate-release tablets, patches, extended-release tablets, oral solution and injection can all contain clonidine yet differ in release, strength basis and use. A shared generic name or milligram figure does not permit self-conversion, assembly or substitution." }, { "zh": "共同降低血压或心率不代表可乐定能与 β 受体阻滞剂、部分钙通道阻滞剂、地高辛或其他降压药自行叠加；完整药单、脉搏、血压和症状需要一起核对。", "en": "A shared effect on pressure or heart rate does not permit self-combining clonidine with a beta blocker, certain calcium-channel blockers, digoxin or another antihypertensive. Review the complete list, pulse, pressure and symptoms together." }, { "zh": "机制不能决定谁应使用可乐定，也不能从一次家庭血压读数判断加量、减量或停药。网页只帮助识别准确产品、来源和说明书边界。", "en": "Mechanism cannot decide who should use clonidine or infer an increase, decrease or stop from one home pressure reading. The site only helps identify the exact product, source and label boundary." } ], "source": { "id": "src_9504fec72f88facb", "label": "FDA：CATAPRES（clonidine hydrochloride）NDA 017407 历史口服普通片标签（2009 年版本）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017407s034lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_regulatory_document", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "CATAPRES / clonidine oral", "generic": "盐酸可乐定普通片", "dosageFormClass": "盐酸可乐定普通口服片；不并入本档案包装身份的产品包括 CATAPRES-TTS 经皮给药系统、DURACLON 注射剂、KAPVAY/JENLOGA/NEXICLON XR 缓释制剂、JAVADIN 口服液、COMBIPRES 固定复方及其他含可乐定产品。共同通用名或 mg 数字不建立剂型换算、频次、减量、分片或替换结论。" }, "labelSource": { "id": "src_469743acbb6b2000", "label": "DailyMed（NLM）：盐酸可乐定普通片 0.05／0.1／0.2／0.3 mg 当前美国通用药标签、十个瓶装 NDC 与六个准确包装面板（ANDA 070923；2026-04）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c83e4e4f-bd0e-449d-958a-dc0d570a01ba", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, "productRoutes": [ { "source": { "id": "src_469743acbb6b2000", "label": "DailyMed（NLM）：盐酸可乐定普通片 0.05／0.1／0.2／0.3 mg 当前美国通用药标签、十个瓶装 NDC 与六个准确包装面板（ANDA 070923；2026-04）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c83e4e4f-bd0e-449d-958a-dc0d570a01ba", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-09-02", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_9504fec72f88facb", "label": "FDA：CATAPRES（clonidine hydrochloride）NDA 017407 历史口服普通片标签（2009 年版本）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017407s034lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_regulatory_document", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-09-02", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-09-02", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "CATAPRES 是盐酸可乐定普通片的美国历史原研/RLD；本页可见包装属于当前通用药，不是原品牌。0.05/0.1/0.2/0.3 mg 是每片含量，100/500/1000 Tablets 是整瓶片数。说明书重点涉及嗜睡、镇静、口干、头晕、站立性低血压、心动过缓和跌倒，以及突然停用后的反跳性高血压、头痛、紧张/激越和震颤。网页不生成个人频次、减量、停药或剂型转换方案。", "history": "CATAPRES 口服片于 1974 年在美国获批。历史品牌 0.1、0.2、0.3 mg RLD 当前均为 DISCN，且并非因安全性或有效性撤回。DailyMed 当前页面则展示 ANDA 070923 的十个通用药瓶装身份，其中 0.05 mg 是当前通用药标签规格，不应倒写成历史 CATAPRES RLD。CATAPRES-TTS 贴剂、DURACLON 注射剂、缓释制剂、口服液与 COMBIPRES 复方均为不同准确产品。", "sourceDocuments": [ { "id": "src_469743acbb6b2000", "label": "DailyMed（NLM）：盐酸可乐定普通片 0.05／0.1／0.2／0.3 mg 当前美国通用药标签、十个瓶装 NDC 与六个准确包装面板（ANDA 070923；2026-04）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c83e4e4f-bd0e-449d-958a-dc0d570a01ba", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, { "id": "src_9504fec72f88facb", "label": "FDA：CATAPRES（clonidine hydrochloride）NDA 017407 历史口服普通片标签（2009 年版本）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017407s034lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_regulatory_document", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, { "id": "src_bbd63a95cbbe6561", "label": "FDA：CATAPRES 口服普通片 NDA 017407 的 1974 年批准、RLD 与剂型历史（NDA 022331 审评）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022331s000_ChemR.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_regulatory_document", "documentKind": "regulatory_review", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" } ], "applicationNumber": "CATAPRES NDA 017407（历史原研/RLD）；clonidine hydrochloride ANDA 070923（当前通用药标签）", "approvalTimeline": [ { "date": "1974-09", "title": { "zh": "CATAPRES 口服普通片在美国获批", "en": "U.S. approval of CATAPRES immediate-release oral tablets" }, "detail": { "zh": "FDA 审评把 CATAPRES NDA 017407 记录为 1974 年 9 月批准的可乐定盐酸盐口服普通片，并列为 RLD。", "en": "FDA review records CATAPRES NDA 017407 as clonidine hydrochloride immediate-release oral tablets approved in Sep 1974 and identifies it as the RLD." }, "source": { "id": "src_bbd63a95cbbe6561", "label": "FDA：CATAPRES 口服普通片 NDA 017407 的 1974 年批准、RLD 与剂型历史（NDA 022331 审评）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022331s000_ChemR.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_regulatory_document", "documentKind": "regulatory_review", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" } }, { "date": "2009", "title": { "zh": "FDA 历史 CATAPRES 标签版本", "en": "Historical FDA CATAPRES label version" }, "detail": { "zh": "FDA 保存 0.1、0.2、0.3 mg CATAPRES 口服片标签；用于历史与安全追溯，不代表当前品牌供应。", "en": "FDA preserves a label for CATAPRES 0.1, 0.2 and 0.3 mg oral tablets. It supports history and safety tracing and does not establish current brand supply." }, "source": { "id": "src_9504fec72f88facb", "label": "FDA：CATAPRES（clonidine hydrochloride）NDA 017407 历史口服普通片标签（2009 年版本）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017407s034lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_regulatory_document", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" } }, { "date": "2026-04-30", "title": { "zh": "当前 TruPharma 通用药标签生效", "en": "Current TruPharma generic label became effective" }, "detail": { "zh": "ANDA 070923 当前标签列出四个每片强度、十个瓶装 NDC 与六个准确包装面板。", "en": "The current label under ANDA 070923 lists four per-tablet strengths, ten bottle NDCs and six exact package panels." }, "source": { "id": "src_469743acbb6b2000", "label": "DailyMed（NLM）：盐酸可乐定普通片 0.05／0.1／0.2／0.3 mg 当前美国通用药标签、十个瓶装 NDC 与六个准确包装面板（ANDA 070923；2026-04）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c83e4e4f-bd0e-449d-958a-dc0d570a01ba", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" } } ], "marketStatus": [ { "market": { "zh": "美国 CATAPRES 口服普通片", "en": "United States — CATAPRES immediate-release oral tablets" }, "status": { "zh": "历史原研/RLD，已停市", "en": "Historical originator/RLD; discontinued" }, "detail": { "zh": "NDA 017407；0.1、0.2、0.3 mg 当前均为 DISCN，且并非因安全性或有效性撤回。", "en": "NDA 017407; the 0.1, 0.2 and 0.3 mg rows are DISCN and not withdrawn for safety or effectiveness." } }, { "market": { "zh": "美国当前通用药", "en": "United States — current generic" }, "status": { "zh": "当前公开通用药标签", "en": "Current public generic label" }, "detail": { "zh": "ANDA 070923；0.05/0.1/0.2/0.3 mg，共十个瓶装 NDC；监管标签不等于实时库存。", "en": "ANDA 070923; 0.05/0.1/0.2/0.3 mg across ten bottle NDCs. A regulatory label is not live stock." } }, { "market": { "zh": "贴剂、注射剂、缓释剂、口服液与复方", "en": "Patch, injection, extended-release, oral solution and combination" }, "status": { "zh": "不同准确产品", "en": "Separate exact products" }, "detail": { "zh": "CATAPRES-TTS、DURACLON、KAPVAY/JENLOGA/NEXICLON XR、JAVADIN 与 COMBIPRES 不并入口服普通片包装，也不建立换算。", "en": "CATAPRES-TTS, DURACLON, KAPVAY/JENLOGA/NEXICLON XR, JAVADIN and COMBIPRES are not merged into the immediate-release oral packs and do not establish a conversion." } }, { "market": { "zh": "美国以外市场", "en": "Markets outside the United States" }, "status": { "zh": "本档案未确认当地品牌、规格、包装或供应", "en": "Local brand, strength, pack and supply are not established" }, "detail": { "zh": "必须按当地药监记录、现行说明书和手中药盒逐项核对。", "en": "Check the local regulator, current label and pack in hand item by item." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "照片里的是 CATAPRES 原研药瓶吗？", "en": "Is the pictured bottle the original CATAPRES product?" }, "answer": { "zh": "不是。图片是 TruPharma ANDA 070923 当前通用药包装面板；CATAPRES 只作为历史原研/RLD 身份展示，本页没有把通用药图片冒充原品牌。", "en": "No. The image is a current TruPharma generic package panel under ANDA 070923. CATAPRES is shown only as the historical originator/RLD identity, and no generic image is presented as the original brand." } }, { "question": { "zh": "有刻痕，是不是可以自己掰片或减量？", "en": "The tablet is scored. Can I split it or taper it myself?" }, "answer": { "zh": "不能由刻痕或算术自行决定。刻痕只帮助核对准确外观；分片、减量和停用还涉及处方、准确产品、个人情况和反跳风险，必须由负责团队或药师给出方案。", "en": "Not from a score or arithmetic alone. The score only helps check exact appearance. Splitting, tapering and stopping depend on the prescription, exact product, individual context and rebound risk and require the responsible team or pharmacist." } }, { "question": { "zh": "口服可乐定能直接换成 CATAPRES-TTS 贴剂吗？", "en": "Can oral clonidine be directly replaced with a CATAPRES-TTS patch?" }, "answer": { "zh": "网页不能这样决定。贴剂按每日标称释放量和一周经皮系统标示，口服片按每片 mg 标示；释放方式、起效时程和连续用药边界不同，不能用共同成分或数字自行换算。", "en": "The site cannot make that decision. The patch is labelled by nominal daily delivery from a one-week transdermal system, while oral tablets state milligrams per tablet. Release and time-course boundaries differ, so a shared ingredient or number cannot create a self-conversion." } }, { "question": { "zh": "为什么不能突然停可乐定？", "en": "Why should clonidine not be stopped abruptly?" }, "answer": { "zh": "标签记录突然停止后可能出现反跳性血压升高、头痛、紧张/激越和震颤，少数严重事件可危及生命。若漏药、呕吐、住院或药物即将用尽，应尽快联系开方团队或药师，而不是由网页生成补服或减量表。", "en": "The label records rebound pressure elevation, headache, nervousness/agitation and tremor after abrupt withdrawal, with rare life-threatening events. Missed medicine, vomiting, hospital admission or a nearly empty supply needs prompt prescriber or pharmacist contact rather than a web-generated catch-up or taper schedule." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "dose-unit-literacy", "same-class-is-not-same-medicine", "interactions-are-not-a-home-scheduling-problem" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/catapres-clonidine-oral/", "en": "https://origindrug.com/en/drugs/catapres-clonidine-oral/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "calan-verapamil-immediate-release", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-09-02", "status": "published_traceable_archive" }, "names": { "brand": "CALAN / verapamil immediate-release", "generic": "盐酸维拉帕米普通片", "aliases": [ "CALAN", "Calan", "verapamil", "verapamil hydrochloride", "verapamil tablets", "维拉帕米", "盐酸维拉帕米", "盐酸维拉帕米片", "异搏定", "NDA 018817", "ANDA 071881", "62135-743-90", "62135-744-90", "62135-745-90", "HP59", "HP 26", "HP 27" ], "marketBrandNames": [ { "name": "CALAN", "market": { "zh": "美国", "en": "United States" }, "evidenceStatus": "historical_regulatory_record", "note": { "zh": "NDA 018817 历史原研/RLD；40、80、120、160 mg 普通片当前列入 DISCN，且标注并非因安全性或有效性撤回。本页不展示历史原品牌包装。", "en": "Historical originator/RLD under NDA 018817. The 40, 80, 120 and 160 mg immediate-release tablets are listed as DISCN and marked as not withdrawn for safety or effectiveness. This page does not display a historical original-brand pack." }, "source": { "id": "src_3d17358ce65b1cf8", "label": "FDA Orange Book 第 46 版（2026）：CALAN NDA 018817 的 40／80／120／160 mg 口服普通片列入 Discontinued Drug Product List", "url": "https://www.fda.gov/media/71474/download", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" } }, { "name": "verapamil hydrochloride tablets", "market": { "zh": "美国", "en": "United States" }, "evidenceStatus": "current_regulatory_record", "note": { "zh": "Chartwell RX ANDA 071881 当前通用药标签；40、80、120 mg 各一个 90 片瓶装。监管标签不等于实时库存。", "en": "Current Chartwell RX generic label under ANDA 071881: one 90-tablet bottle each for 40, 80 and 120 mg. A regulatory label is not live stock." }, "source": { "id": "src_171abcbe4566484a", "label": "DailyMed（NLM）：盐酸维拉帕米普通片 40／80／120 mg 当前美国通用药标签、三个 90 片瓶装 NDC 与三个准确包装面板（ANDA 071881；2025-12 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ebc9a09a-7b5f-4df6-ace7-31185d469b28", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" } } ], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "心血管", "sourceArchiveMarket": "FDA Orange Book 第 46 版把 CALAN NDA 018817 的 40、80、120、160 mg 口服普通片列入停市清单，并以脚注注明并非因安全性或有效性撤回。当前准确包装来自 Chartwell RX ANDA 071881 通用药标签：40、80、120 mg，各一个 90 片瓶装与对应准确包装面板。历史品牌、当前通用药及不同释放/给药产品不得混写。", "dosageFormClass": "盐酸维拉帕米普通口服片；CALAN SR、VERELAN、VERELAN PM、COVERA-HS、ISOPTIN SR 等缓释或节律释放产品以及注射剂均是不同准确产品。共同通用名或 mg 数字不建立换算、频次、分片、叠加或替换结论。", "dosageFormClassCode": "oral_modified_release", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "1984（CALAN 美国口服普通片 NDA 018817 的 80／120 mg 批准年份）", "archiveSponsorText": "CALAN 历史原研/RLD（Pfizer／G.D. Searle）；Chartwell RX, LLC 为当前展示通用药标签方" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [ "CALAN", "verapamil", "verapamil hydrochloride", "verapamil tablets", "维拉帕米", "盐酸维拉帕米", "盐酸维拉帕米片", "异搏定" ], "excludedProductCues": [ "CALAN SR", "VERELAN", "VERELAN PM", "COVERA-HS", "ISOPTIN SR", "verapamil extended release", "verapamil injection", "维拉帕米缓释", "维拉帕米注射液" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-generic-verapamil-ir-40mg-90-tablet-bottle-ndc-6213574390", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国通用药标签（页面 2025-12-10 更新；正文 Revised 08/2023）", "en": "Current U.S. DailyMed generic label (page updated 10 Dec 2025; text revised Aug 2023)" }, "dosageForm": { "zh": "盐酸维拉帕米普通薄膜衣口服片", "en": "verapamil hydrochloride immediate-release film-coated oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 62135-743-90", "pouchCode": null, "applicationNumber": "ANDA 071881", "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片盐酸维拉帕米 40 mg；90 片瓶装", "en": "40 mg verapamil hydrochloride per tablet; 90-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=verapamil-hcl-tablets-usp-40mg-bottle-label.jpg&setid=ebc9a09a-7b5f-4df6-ace7-31185d469b28&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "盐酸维拉帕米", "en": "verapamil hydrochloride" }, "value": 40, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、频次、分片指令，也不是与 CALAN SR、VERELAN、VERELAN PM、其他缓释制剂或注射剂的换算值", "en": "labelled amount per tablet; not an individual's tablet count, frequency, splitting instruction or conversion to CALAN SR, VERELAN, VERELAN PM, another extended-release product or an injection" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 90, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-02", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "current_regulatory_listing_not_live_stock", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 90, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "白色", "en": "white" }, "shape": { "zh": "圆形普通薄膜衣片", "en": "round immediate-release film-coated tablet" }, "imprint": "HP59", "scoreStatus": "unscored_no_self_split_permission", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_171abcbe4566484a", "label": "DailyMed（NLM）：盐酸维拉帕米普通片 40／80／120 mg 当前美国通用药标签、三个 90 片瓶装 NDC 与三个准确包装面板（ANDA 071881；2025-12 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ebc9a09a-7b5f-4df6-ace7-31185d469b28", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-generic-verapamil-ir-80mg-90-tablet-bottle-ndc-6213574490", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国通用药标签（页面 2025-12-10 更新；正文 Revised 08/2023）", "en": "Current U.S. DailyMed generic label (page updated 10 Dec 2025; text revised Aug 2023)" }, "dosageForm": { "zh": "盐酸维拉帕米普通薄膜衣口服片", "en": "verapamil hydrochloride immediate-release film-coated oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 62135-744-90", "pouchCode": null, "applicationNumber": "ANDA 071881", "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片盐酸维拉帕米 80 mg；90 片瓶装", "en": "80 mg verapamil hydrochloride per tablet; 90-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=verapamil-hcl-tablets-usp-80mg-bottle-label.jpg&setid=ebc9a09a-7b5f-4df6-ace7-31185d469b28&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "盐酸维拉帕米", "en": "verapamil hydrochloride" }, "value": 80, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、频次、分片指令，也不是与 CALAN SR、VERELAN、VERELAN PM、其他缓释制剂或注射剂的换算值", "en": "labelled amount per tablet; not an individual's tablet count, frequency, splitting instruction or conversion to CALAN SR, VERELAN, VERELAN PM, another extended-release product or an injection" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 90, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-02", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "current_regulatory_listing_not_live_stock", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 90, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "白色", "en": "white" }, "shape": { "zh": "圆形普通薄膜衣片", "en": "round immediate-release film-coated tablet" }, "imprint": "HP;26", "scoreStatus": "scored_appearance_clue_not_self_split_permission", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_171abcbe4566484a", "label": "DailyMed（NLM）：盐酸维拉帕米普通片 40／80／120 mg 当前美国通用药标签、三个 90 片瓶装 NDC 与三个准确包装面板（ANDA 071881；2025-12 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ebc9a09a-7b5f-4df6-ace7-31185d469b28", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-generic-verapamil-ir-120mg-90-tablet-bottle-ndc-6213574590", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国通用药标签（页面 2025-12-10 更新；正文 Revised 08/2023）", "en": "Current U.S. DailyMed generic label (page updated 10 Dec 2025; text revised Aug 2023)" }, "dosageForm": { "zh": "盐酸维拉帕米普通薄膜衣口服片", "en": "verapamil hydrochloride immediate-release film-coated oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 62135-745-90", "pouchCode": null, "applicationNumber": "ANDA 071881", "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片盐酸维拉帕米 120 mg；90 片瓶装", "en": "120 mg verapamil hydrochloride per tablet; 90-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=verapamil-hcl-tablets-usp-120mg-bottle-label.jpg&setid=ebc9a09a-7b5f-4df6-ace7-31185d469b28&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "盐酸维拉帕米", "en": "verapamil hydrochloride" }, "value": 120, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、频次、分片指令，也不是与 CALAN SR、VERELAN、VERELAN PM、其他缓释制剂或注射剂的换算值", "en": "labelled amount per tablet; not an individual's tablet count, frequency, splitting instruction or conversion to CALAN SR, VERELAN, VERELAN PM, another extended-release product or an injection" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 90, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-02", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "current_regulatory_listing_not_live_stock", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 90, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "白色", "en": "white" }, "shape": { "zh": "圆形普通薄膜衣片", "en": "round immediate-release film-coated tablet" }, "imprint": "HP;27", "scoreStatus": "scored_appearance_clue_not_self_split_permission", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_171abcbe4566484a", "label": "DailyMed（NLM）：盐酸维拉帕米普通片 40／80／120 mg 当前美国通用药标签、三个 90 片瓶装 NDC 与三个准确包装面板（ANDA 071881；2025-12 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ebc9a09a-7b5f-4df6-ace7-31185d469b28", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-generic-verapamil-ir-40mg-90-tablet-bottle-ndc-6213574390", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=verapamil-hcl-tablets-usp-40mg-bottle-label.jpg&setid=ebc9a09a-7b5f-4df6-ace7-31185d469b28&type=img", "alt": "Chartwell RX 盐酸维拉帕米 40 mg、NDC 62135-743-90、90 片瓶装的 DailyMed 官方通用药标签面板", "archiveMarket": "美国", "labelVersion": "DailyMed 当前美国通用药标签（2025 页面更新）", "presentation": "40 mg：白色圆形、无刻痕、印有 HP59；NDC 62135-743-90，90 片瓶装。", "notice": "此图是当前通用药包装标签，不是 CALAN 历史原品牌包装；只对应 NDC 62135-743-90，不代表 80/120 mg、CALAN SR、VERELAN、VERELAN PM、其他缓释产品、注射剂、其他厂商或其他市场，也不用于鉴定真伪。", "source": { "id": "src_171abcbe4566484a", "label": "DailyMed（NLM）：盐酸维拉帕米普通片 40／80／120 mg 当前美国通用药标签、三个 90 片瓶装 NDC 与三个准确包装面板（ANDA 071881；2025-12 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ebc9a09a-7b5f-4df6-ace7-31185d469b28", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "盐酸维拉帕米说明书放大阅读：每片 mg、整瓶片数、心率传导、便秘与多药核对", "en": "Verapamil enlarged label: per-tablet mg, bottle count, heart rate/conduction, constipation and medicine-list review" }, "summary": { "zh": "40、80、120 mg 是每片含量；90 Tablets 是整瓶片数。当前 40 mg 通用药片无刻痕，80/120 mg 有刻痕，但刻痕只是准确产品外观与标签线索，不自动构成自行掰片许可；历史 CALAN 80 mg 的刻痕标签也不能推广到其他厂商、规格或缓释产品。", "en": "The 40, 80 and 120 mg figures are amounts per tablet; 90 Tablets is the bottle count. The current 40 mg generic tablet is unscored and the 80/120 mg tablets are scored, but a score is an exact-product appearance and label clue, not automatic permission to self-split. Historical CALAN 80 mg score labelling cannot be extended to another manufacturer, strength or extended-release product." }, "checks": [ { "zh": "低血压、眩晕、晕厥、心动过缓或房室传导阻滞可能增加跌倒和急性风险。老人、多药使用者或已有心率/传导问题者应把脉搏、症状、全部药盒和处方一起交给医生或药师核对；严重晕厥、胸痛、呼吸困难或意识异常应使用当地急救。", "en": "Hypotension, dizziness, syncope, bradycardia or atrioventricular block can increase fall and acute risk. Older adults, people using several medicines or those with heart-rate/conduction problems should have pulse, symptoms, every pack and the prescription reviewed together. Severe fainting, chest pain, breathing difficulty or altered awareness needs local emergency care." }, { "zh": "标签警示心衰和心肌收缩受影响；与 β 受体阻滞剂、地高辛、可乐定、胺碘酮或其他影响心率/传导/血压的药同时出现时，不要自行错开、加减、轮换或先停其中一种。", "en": "The label warns about heart failure and impaired cardiac contractility. If a beta blocker, digoxin, clonidine, amiodarone or another heart-rate/conduction/blood-pressure medicine is also present, do not self-space, add, reduce, alternate or choose one to stop first." }, { "zh": "便秘是常见不良反应，标签还记录罕见非梗阻性麻痹性肠梗阻。持续腹胀、剧烈腹痛、呕吐或无法排气排便需要及时医疗评估，不能仅在网页上寻找通便方案。", "en": "Constipation is common, and the label also records rare non-obstructive paralytic ileus. Persistent distension, severe abdominal pain, vomiting or inability to pass gas or stool needs timely medical assessment, not only a web search for a laxative plan." }, { "zh": "标签列出与辛伐他汀、洛伐他汀及其他 CYP3A4 底物/抑制剂、地高辛、锂、葡萄柚汁等的相互作用线索。网页不根据两个药名或食物名决定能否同用、怎样减量或怎样错开。", "en": "The label lists interaction cues with simvastatin, lovastatin and other CYP3A4 substrates/inhibitors, digoxin, lithium and grapefruit juice. The site does not decide co-use, dose reduction or timing from two medicine or food names." }, { "zh": "普通片与 CALAN SR、VERELAN、VERELAN PM、COVERA-HS 等产品的释放方式和标签不同；不要把相同通用名、相近 mg 或‘一天一次’等文字当作换算表。", "en": "Immediate-release tablets and products such as CALAN SR, VERELAN, VERELAN PM and COVERA-HS differ in release and labelling. Do not treat a shared generic name, similar milligrams or wording such as once daily as a conversion table." } ], "source": { "id": "src_171abcbe4566484a", "label": "DailyMed（NLM）：盐酸维拉帕米普通片 40／80／120 mg 当前美国通用药标签、三个 90 片瓶装 NDC 与三个准确包装面板（ANDA 071881；2025-12 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ebc9a09a-7b5f-4df6-ace7-31185d469b28", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "维拉帕米怎样起作用：阻断慢钙通道会同时影响血管、心肌和心脏传导", "en": "How verapamil works: slow calcium-channel blockade affects vessels, myocardium and cardiac conduction" }, "summary": { "zh": "说明书将维拉帕米归为钙离子流入抑制剂/慢通道阻滞剂。它可影响动脉平滑肌，也影响心肌收缩与传导细胞；这有助理解降压、心率变慢、传导阻滞和心衰风险为何要一起看，但不能预测个人反应或生成剂量。", "en": "The label classifies verapamil as a calcium-ion influx inhibitor/slow-channel blocker. It can affect arterial smooth muscle, myocardial contraction and conduction cells. This helps explain why blood pressure, slower heart rate, conduction block and heart-failure risk must be reviewed together, but it cannot predict an individual's response or generate a dose." }, "checks": [ { "zh": "与地尔硫卓同属非二氢吡啶类钙通道阻滞剂，不代表两者可以按 mg 互换、同日轮换或叠加；它们仍是不同成分、产品、标签和处方。", "en": "Sharing the nondihydropyridine calcium-channel-blocker class with diltiazem does not permit milligram conversion, same-day alternation or combination. They remain different ingredients, products, labels and prescriptions." }, { "zh": "共同降低心率或血压不等于可与 β 受体阻滞剂、地高辛、可乐定或胺碘酮自行叠加。心率、心电传导、心功能、血压、肝功能和完整药单需要一起核对。", "en": "A shared effect on heart rate or pressure does not permit self-combining verapamil with a beta blocker, digoxin, clonidine or amiodarone. Heart rate, ECG conduction, cardiac function, pressure, liver function and the complete medicine list need joint review." }, { "zh": "作用机制不能决定谁适合维拉帕米，也不能从一次血压或脉搏读数决定加量、减量或停药。网页只帮助识别准确产品、来源和说明书边界。", "en": "Mechanism cannot decide who is suited to verapamil or use one blood-pressure or pulse reading to decide an increase, decrease or stop. The site only helps identify the exact product, source and label boundary." } ], "source": { "id": "src_171abcbe4566484a", "label": "DailyMed（NLM）：盐酸维拉帕米普通片 40／80／120 mg 当前美国通用药标签、三个 90 片瓶装 NDC 与三个准确包装面板（ANDA 071881；2025-12 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ebc9a09a-7b5f-4df6-ace7-31185d469b28", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "CALAN / verapamil immediate-release", "generic": "盐酸维拉帕米普通片", "dosageFormClass": "盐酸维拉帕米普通口服片；CALAN SR、VERELAN、VERELAN PM、COVERA-HS、ISOPTIN SR 等缓释或节律释放产品以及注射剂均是不同准确产品。共同通用名或 mg 数字不建立换算、频次、分片、叠加或替换结论。" }, "labelSource": { "id": "src_171abcbe4566484a", "label": "DailyMed（NLM）：盐酸维拉帕米普通片 40／80／120 mg 当前美国通用药标签、三个 90 片瓶装 NDC 与三个准确包装面板（ANDA 071881；2025-12 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ebc9a09a-7b5f-4df6-ace7-31185d469b28", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, "productRoutes": [ { "source": { "id": "src_171abcbe4566484a", "label": "DailyMed（NLM）：盐酸维拉帕米普通片 40／80／120 mg 当前美国通用药标签、三个 90 片瓶装 NDC 与三个准确包装面板（ANDA 071881；2025-12 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ebc9a09a-7b5f-4df6-ace7-31185d469b28", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-09-02", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_c3b83a27bd081a53", "label": "FDA：CALAN（verapamil hydrochloride）NDA 018817 历史口服普通片标签（2009 年版本）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/018817s021lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_regulatory_document", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-09-02", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_3d17358ce65b1cf8", "label": "FDA Orange Book 第 46 版（2026）：CALAN NDA 018817 的 40／80／120／160 mg 口服普通片列入 Discontinued Drug Product List", "url": "https://www.fda.gov/media/71474/download", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-09-02", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-09-02", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "CALAN 是盐酸维拉帕米普通片的美国历史原研/RLD；本页可见包装属于当前通用药，不是 CALAN 原品牌。40/80/120 mg 是每片含量，90 Tablets 是整瓶片数。说明书重点涉及低血压、心动过缓、房室传导阻滞、心衰、便秘和跌倒，以及与 β 受体阻滞剂、地高辛、可乐定、辛伐他汀/洛伐他汀、葡萄柚和多种 CYP3A4 相关药物的核对。网页不生成个人片数、频次、分片、错开或换药方案。", "history": "CALAN 普通片的 80 mg 与 120 mg 于 1984 年在美国获批，40 mg 与 160 mg 于 1988 年获批。2021 年 FDA 补充批准信涉及现有 80 mg 刻痕的功能与拆分后储存标签更新；这只属于准确 CALAN 产品的专业标签记录，不能推广为任何维拉帕米片都能自行掰开。当前 DailyMed 页面展示的是 ANDA 071881 通用药三个 90 片瓶装，不是历史 CALAN 包装。", "sourceDocuments": [ { "id": "src_171abcbe4566484a", "label": "DailyMed（NLM）：盐酸维拉帕米普通片 40／80／120 mg 当前美国通用药标签、三个 90 片瓶装 NDC 与三个准确包装面板（ANDA 071881；2025-12 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ebc9a09a-7b5f-4df6-ace7-31185d469b28", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, { "id": "src_c3b83a27bd081a53", "label": "FDA：CALAN（verapamil hydrochloride）NDA 018817 历史口服普通片标签（2009 年版本）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/018817s021lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_regulatory_document", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, { "id": "src_46eb030128963fbd", "label": "FDA：CALAN NDA 018817／S-035 补充批准信（2021；80 mg 刻痕功能与标签更新）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/018817Orig1s035ltr.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_regulatory_document", "documentKind": "regulatory_approval_letter", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, { "id": "src_3d17358ce65b1cf8", "label": "FDA Orange Book 第 46 版（2026）：CALAN NDA 018817 的 40／80／120／160 mg 口服普通片列入 Discontinued Drug Product List", "url": "https://www.fda.gov/media/71474/download", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" } ], "applicationNumber": "CALAN NDA 018817（历史原研/RLD）；verapamil hydrochloride ANDA 071881（当前通用药标签）", "approvalTimeline": [ { "date": "1984-09-10", "title": { "zh": "CALAN 80／120 mg 普通片在美国获批", "en": "U.S. approval of CALAN 80/120 mg immediate-release tablets" }, "detail": { "zh": "FDA Orange Book 记录 NDA 018817 的 80 mg 与 120 mg 于 1984 年获批。", "en": "The FDA Orange Book records approval of NDA 018817 80 mg and 120 mg tablets in 1984." }, "source": { "id": "src_3d17358ce65b1cf8", "label": "FDA Orange Book 第 46 版（2026）：CALAN NDA 018817 的 40／80／120／160 mg 口服普通片列入 Discontinued Drug Product List", "url": "https://www.fda.gov/media/71474/download", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" } }, { "date": "1988-02-23", "title": { "zh": "CALAN 40／160 mg 普通片获批", "en": "Approval of CALAN 40/160 mg immediate-release tablets" }, "detail": { "zh": "FDA Orange Book 记录 NDA 018817 的 40 mg 与 160 mg 于 1988 年获批。", "en": "The FDA Orange Book records approval of NDA 018817 40 mg and 160 mg tablets in 1988." }, "source": { "id": "src_3d17358ce65b1cf8", "label": "FDA Orange Book 第 46 版（2026）：CALAN NDA 018817 的 40／80／120／160 mg 口服普通片列入 Discontinued Drug Product List", "url": "https://www.fda.gov/media/71474/download", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" } }, { "date": "2021-06-22", "title": { "zh": "FDA 批准 80 mg 刻痕功能标签更新", "en": "FDA approved the 80 mg score-function labelling update" }, "detail": { "zh": "补充批准信只支持准确 CALAN 80 mg 产品的标签历史，不为其他维拉帕米片建立通用分片许可。", "en": "The supplement letter supports the exact CALAN 80 mg product's labelling history and does not create general splitting permission for other verapamil tablets." }, "source": { "id": "src_46eb030128963fbd", "label": "FDA：CALAN NDA 018817／S-035 补充批准信（2021；80 mg 刻痕功能与标签更新）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/018817Orig1s035ltr.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_regulatory_document", "documentKind": "regulatory_approval_letter", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" } }, { "date": "2025-12-10", "title": { "zh": "当前 Chartwell RX 通用药页面更新", "en": "Current Chartwell RX generic page updated" }, "detail": { "zh": "ANDA 071881 当前页面列出 40／80／120 mg 三个 90 片瓶装及准确包装面板。", "en": "The current ANDA 071881 page lists three 90-tablet bottles for 40, 80 and 120 mg with exact package panels." }, "source": { "id": "src_171abcbe4566484a", "label": "DailyMed（NLM）：盐酸维拉帕米普通片 40／80／120 mg 当前美国通用药标签、三个 90 片瓶装 NDC 与三个准确包装面板（ANDA 071881；2025-12 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ebc9a09a-7b5f-4df6-ace7-31185d469b28", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" } } ], "marketStatus": [ { "market": { "zh": "美国 CALAN 普通片", "en": "United States — CALAN immediate-release tablets" }, "status": { "zh": "历史原研/RLD，已停市", "en": "Historical originator/RLD; discontinued" }, "detail": { "zh": "NDA 018817；40、80、120、160 mg 均列入 DISCN，并以脚注注明并非因安全性或有效性撤回。", "en": "NDA 018817; 40, 80, 120 and 160 mg are listed as DISCN and footnoted as not withdrawn for safety or effectiveness." } }, { "market": { "zh": "美国当前通用药", "en": "United States — current generic" }, "status": { "zh": "当前公开通用药标签", "en": "Current public generic label" }, "detail": { "zh": "ANDA 071881；40／80／120 mg，各一个 90 片瓶装。", "en": "ANDA 071881; one 90-tablet bottle each for 40, 80 and 120 mg." } }, { "market": { "zh": "缓释、节律释放与注射剂", "en": "Extended-release, chronotherapeutic and injectable products" }, "status": { "zh": "不同准确产品", "en": "Separate exact products" }, "detail": { "zh": "CALAN SR、VERELAN、VERELAN PM、COVERA-HS、ISOPTIN SR 和注射剂不并入本普通片档案，也不建立换算。", "en": "CALAN SR, VERELAN, VERELAN PM, COVERA-HS, ISOPTIN SR and injections are not merged into this immediate-release dossier and no conversion is established." } }, { "market": { "zh": "美国以外市场", "en": "Markets outside the United States" }, "status": { "zh": "本档案未确认当地品牌、规格、包装或供应", "en": "Local brand, strength, pack and supply are not established" }, "detail": { "zh": "异搏定等当地名称必须按当地药监记录、现行说明书和手中药盒逐项核对。", "en": "Local names such as Isoptin must be checked item by item against the local regulator, current label and pack in hand." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "照片里的是 CALAN 原研药瓶吗？", "en": "Is the pictured bottle the original CALAN product?" }, "answer": { "zh": "不是。图片是 Chartwell RX ANDA 071881 当前通用药包装面板；CALAN 只作为历史原研/RLD 身份展示。", "en": "No. The image is a current Chartwell RX generic package panel under ANDA 071881. CALAN is shown only as the historical originator/RLD identity." } }, { "question": { "zh": "90 Tablets 是一次吃 90 片吗？", "en": "Does 90 Tablets mean taking 90 tablets at once?" }, "answer": { "zh": "不是。90 Tablets 是整瓶片数；40／80／120 mg 才是每片标签含量。网页不会把瓶数或 mg 变成个人片数或频次。", "en": "No. 90 Tablets is the bottle count; 40/80/120 mg is the labelled amount per tablet. The site does not turn bottle count or milligrams into an individual's tablet count or frequency." } }, { "question": { "zh": "有刻痕就一定可以掰开吗？", "en": "Does a score always mean the tablet can be split?" }, "answer": { "zh": "不能这样判断。刻痕属于准确产品的外观和标签信息；是否可分、分后如何保存及是否符合处方，都必须核对具体厂家现行标签、处方和药师意见。缓释产品尤其不能借普通片刻痕自行处理。", "en": "No. A score is exact-product appearance and label information. Splitting, storage after splitting and prescription fit require the exact manufacturer's current label, prescription and pharmacist review. An immediate-release score must never be extended to an extended-release product." } }, { "question": { "zh": "维拉帕米和地尔硫卓可以轮换吗？", "en": "Can verapamil and diltiazem be alternated?" }, "answer": { "zh": "网页不能据同类药身份建立轮换或换算。两者都是不同成分和处方，且都可能影响心率、传导、血压与相互作用；需要完整药单和临床情况共同评估。", "en": "The site cannot create alternation or conversion from a shared class. They are different ingredients and prescriptions, and both can affect heart rate, conduction, pressure and interactions; the complete medicine list and clinical context require joint review." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "dosage-forms-are-part-of-medicine-identity", "same-class-is-not-same-medicine", "interactions-are-not-a-home-scheduling-problem" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/calan-verapamil-immediate-release/", "en": "https://origindrug.com/en/drugs/calan-verapamil-immediate-release/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "betapace-sotalol", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-09-02", "status": "published_traceable_archive" }, "names": { "brand": "BETAPACE / BETAPACE AF", "generic": "盐酸索他洛尔片", "aliases": [ "BETAPACE", "Betapace", "BETAPACE AF", "Betapace AF", "sotalol", "sotalol hydrochloride", "索他洛尔", "盐酸索他洛尔", "盐酸索他洛尔片", "sotalol tablets", "NDA 019865", "NDA 021151", "83107-005-10", "83107-006-10", "83107-007-10", "83107-008-60", "83107-009-60", "83107-010-60", "BETAPACE 80 MG", "BETAPACE 120 MG", "BETAPACE 160 MG", "BHCP 80 MG", "BHCP 120 MG", "BHCP 160 MG" ], "marketBrandNames": [ { "name": "BETAPACE", "market": { "zh": "美国", "en": "United States" }, "evidenceStatus": "current_regulatory_record", "note": { "zh": "NDA 019865 原研/RLD；当前标签展示浅蓝色 80／120／160 mg、各 100 片瓶装。Orange Book 另有 240 mg 活跃条目，但当前准确包装页面未展示，本站不补造包装。", "en": "Originator/RLD under NDA 019865. The current label displays light-blue 80, 120 and 160 mg tablets in 100-tablet bottles. The Orange Book also lists an active 240 mg row, but the current exact-package page does not display it, so this site does not invent a pack." }, "source": { "id": "src_2133e5eac8c74c36", "label": "DailyMed（NLM）：BETAPACE／BETAPACE AF 盐酸索他洛尔 80／120／160 mg 当前美国原品牌标签、六个 NDC 与六个准确包装面板（NDA 019865／021151；2024-12 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a6a7702f-36c9-45db-b640-453dc324baee", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" } }, { "name": "BETAPACE AF", "market": { "zh": "美国", "en": "United States" }, "evidenceStatus": "current_regulatory_record", "note": { "zh": "独立 NDA 021151；当前标签展示白色 80／120／160 mg、各 60 片患者包装。与 BETAPACE 共同成分不等于可以自行替换。", "en": "Separate NDA 021151. The current label displays white 80, 120 and 160 mg tablets in 60-tablet patient packs. A shared ingredient with BETAPACE does not permit self-substitution." }, "source": { "id": "src_2133e5eac8c74c36", "label": "DailyMed（NLM）：BETAPACE／BETAPACE AF 盐酸索他洛尔 80／120／160 mg 当前美国原品牌标签、六个 NDC 与六个准确包装面板（NDA 019865／021151；2024-12 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a6a7702f-36c9-45db-b640-453dc324baee", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" } } ], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "心血管", "sourceArchiveMarket": "FDA Orange Book 第 46 版把 BETAPACE NDA 019865 的 80／120／160／240 mg 列为活跃口服片，其中 160 mg 标为 RLD/RS；BETAPACE AF NDA 021151 的 80／120／160 mg 列为活跃口服片，其中 160 mg 标为 RLD/RS。当前 DailyMed 准确包装仅展示两个品牌系列各 80／120／160 mg，共六个瓶装。本页不把 Orange Book 其他规格推写为当前可见包装，也不把监管条目写成实时库存。", "dosageFormClass": "BETAPACE 与 BETAPACE AF 都含盐酸索他洛尔，但属于不同 NDA、适应证标签与患者包装路径；SOTYLIZE 口服液、静脉注射剂、其他品牌或仿制品也是不同准确产品。共同成分或相同 mg 不建立自行换算、轮换、叠加、补服、分片或替换结论。", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "1992（BETAPACE 美国首次批准）", "archiveSponsorText": "Legacy Pharma（当前 BETAPACE／BETAPACE AF 标签方）；BETAPACE 为 NDA 019865 原研/RLD" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [ "BETAPACE", "BETAPACE AF", "sotalol", "sotalol hydrochloride", "索他洛尔", "盐酸索他洛尔", "盐酸索他洛尔片" ], "excludedProductCues": [ "SOTYLIZE", "sotalol oral solution", "sotalol injection", "intravenous sotalol", "索他洛尔口服液", "索他洛尔注射液", "SORINE" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-betapace-sotalol-80mg-100-tablet-bottle-ndc-8310700510", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国原品牌标签（2024-12-16 更新；Rev. 8/24）", "en": "Current U.S. originator-brand DailyMed label (updated 16 Dec 2024; Rev. 8/24)" }, "dosageForm": { "zh": "BETAPACE 盐酸索他洛尔刻痕口服片", "en": "BETAPACE scored sotalol hydrochloride oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 83107-005-10", "pouchCode": null, "applicationNumber": "NDA 019865", "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片盐酸索他洛尔 80 mg；100 片瓶装", "en": "80 mg sotalol hydrochloride per tablet; 100-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=betapace-tabs-80mg-100s-bottle-label.jpg&setid=a6a7702f-36c9-45db-b640-453dc324baee", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "盐酸索他洛尔", "en": "sotalol hydrochloride" }, "value": 80, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、频次、补服、分片指令，也不是 BETAPACE 与 BETAPACE AF、SOTYLIZE 口服液、静脉注射剂或其他抗心律失常药的换算值", "en": "labelled amount per tablet; not an individual's tablet count, frequency, catch-up or splitting instruction, and not a conversion between BETAPACE and BETAPACE AF, SOTYLIZE oral solution, intravenous sotalol or another antiarrhythmic" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-02", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "current_regulatory_listing_not_live_stock", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "浅蓝色", "en": "light blue" }, "shape": { "zh": "胶囊形／椭圆形刻痕片", "en": "capsule-shaped or oval scored tablet" }, "imprint": "BETAPACE;80;MG", "scoreStatus": "scored_appearance_clue_not_self_split_permission", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_2133e5eac8c74c36", "label": "DailyMed（NLM）：BETAPACE／BETAPACE AF 盐酸索他洛尔 80／120／160 mg 当前美国原品牌标签、六个 NDC 与六个准确包装面板（NDA 019865／021151；2024-12 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a6a7702f-36c9-45db-b640-453dc324baee", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-betapace-sotalol-120mg-100-tablet-bottle-ndc-8310700610", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国原品牌标签（2024-12-16 更新；Rev. 8/24）", "en": "Current U.S. originator-brand DailyMed label (updated 16 Dec 2024; Rev. 8/24)" }, "dosageForm": { "zh": "BETAPACE 盐酸索他洛尔刻痕口服片", "en": "BETAPACE scored sotalol hydrochloride oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 83107-006-10", "pouchCode": null, "applicationNumber": "NDA 019865", "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片盐酸索他洛尔 120 mg；100 片瓶装", "en": "120 mg sotalol hydrochloride per tablet; 100-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=betapace-tabs-120mg-100s-bottle-label.jpg&setid=a6a7702f-36c9-45db-b640-453dc324baee", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "盐酸索他洛尔", "en": "sotalol hydrochloride" }, "value": 120, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、频次、补服、分片指令，也不是 BETAPACE 与 BETAPACE AF、SOTYLIZE 口服液、静脉注射剂或其他抗心律失常药的换算值", "en": "labelled amount per tablet; not an individual's tablet count, frequency, catch-up or splitting instruction, and not a conversion between BETAPACE and BETAPACE AF, SOTYLIZE oral solution, intravenous sotalol or another antiarrhythmic" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-02", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "current_regulatory_listing_not_live_stock", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "浅蓝色", "en": "light blue" }, "shape": { "zh": "胶囊形／椭圆形刻痕片", "en": "capsule-shaped or oval scored tablet" }, "imprint": "BETAPACE;120;MG", "scoreStatus": "scored_appearance_clue_not_self_split_permission", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_2133e5eac8c74c36", "label": "DailyMed（NLM）：BETAPACE／BETAPACE AF 盐酸索他洛尔 80／120／160 mg 当前美国原品牌标签、六个 NDC 与六个准确包装面板（NDA 019865／021151；2024-12 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a6a7702f-36c9-45db-b640-453dc324baee", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-betapace-sotalol-160mg-100-tablet-bottle-ndc-8310700710", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国原品牌标签（2024-12-16 更新；Rev. 8/24）", "en": "Current U.S. originator-brand DailyMed label (updated 16 Dec 2024; Rev. 8/24)" }, "dosageForm": { "zh": "BETAPACE 盐酸索他洛尔刻痕口服片", "en": "BETAPACE scored sotalol hydrochloride oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 83107-007-10", "pouchCode": null, "applicationNumber": "NDA 019865", "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片盐酸索他洛尔 160 mg；100 片瓶装", "en": "160 mg sotalol hydrochloride per tablet; 100-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=betapace-tabs-160mg-100s-bottle-label.jpg&setid=a6a7702f-36c9-45db-b640-453dc324baee", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "盐酸索他洛尔", "en": "sotalol hydrochloride" }, "value": 160, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、频次、补服、分片指令，也不是 BETAPACE 与 BETAPACE AF、SOTYLIZE 口服液、静脉注射剂或其他抗心律失常药的换算值", "en": "labelled amount per tablet; not an individual's tablet count, frequency, catch-up or splitting instruction, and not a conversion between BETAPACE and BETAPACE AF, SOTYLIZE oral solution, intravenous sotalol or another antiarrhythmic" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-02", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "current_regulatory_listing_not_live_stock", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "浅蓝色", "en": "light blue" }, "shape": { "zh": "胶囊形／椭圆形刻痕片", "en": "capsule-shaped or oval scored tablet" }, "imprint": "BETAPACE;160;MG", "scoreStatus": "scored_appearance_clue_not_self_split_permission", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_2133e5eac8c74c36", "label": "DailyMed（NLM）：BETAPACE／BETAPACE AF 盐酸索他洛尔 80／120／160 mg 当前美国原品牌标签、六个 NDC 与六个准确包装面板（NDA 019865／021151；2024-12 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a6a7702f-36c9-45db-b640-453dc324baee", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-betapace-af-sotalol-80mg-60-tablet-bottle-ndc-8310700860", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国原品牌标签（2024-12-16 更新；Rev. 8/24）", "en": "Current U.S. originator-brand DailyMed label (updated 16 Dec 2024; Rev. 8/24)" }, "dosageForm": { "zh": "BETAPACE AF 盐酸索他洛尔刻痕口服片", "en": "BETAPACE AF scored sotalol hydrochloride oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 83107-008-60", "pouchCode": null, "applicationNumber": "NDA 021151", "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片盐酸索他洛尔 80 mg；60 片瓶装", "en": "80 mg sotalol hydrochloride per tablet; 60-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=betapace-af-tabs-80mg-60s-bottle-label.jpg&setid=a6a7702f-36c9-45db-b640-453dc324baee", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "盐酸索他洛尔", "en": "sotalol hydrochloride" }, "value": 80, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、频次、补服、分片指令，也不是 BETAPACE 与 BETAPACE AF、SOTYLIZE 口服液、静脉注射剂或其他抗心律失常药的换算值", "en": "labelled amount per tablet; not an individual's tablet count, frequency, catch-up or splitting instruction, and not a conversion between BETAPACE and BETAPACE AF, SOTYLIZE oral solution, intravenous sotalol or another antiarrhythmic" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 60, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-02", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "current_regulatory_listing_not_live_stock", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 60, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "白色", "en": "white" }, "shape": { "zh": "胶囊形／椭圆形刻痕片", "en": "capsule-shaped or oval scored tablet" }, "imprint": "BHCP;80;MG", "scoreStatus": "scored_appearance_clue_not_self_split_permission", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_2133e5eac8c74c36", "label": "DailyMed（NLM）：BETAPACE／BETAPACE AF 盐酸索他洛尔 80／120／160 mg 当前美国原品牌标签、六个 NDC 与六个准确包装面板（NDA 019865／021151；2024-12 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a6a7702f-36c9-45db-b640-453dc324baee", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-betapace-af-sotalol-120mg-60-tablet-bottle-ndc-8310700960", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国原品牌标签（2024-12-16 更新；Rev. 8/24）", "en": "Current U.S. originator-brand DailyMed label (updated 16 Dec 2024; Rev. 8/24)" }, "dosageForm": { "zh": "BETAPACE AF 盐酸索他洛尔刻痕口服片", "en": "BETAPACE AF scored sotalol hydrochloride oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 83107-009-60", "pouchCode": null, "applicationNumber": "NDA 021151", "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片盐酸索他洛尔 120 mg；60 片瓶装", "en": "120 mg sotalol hydrochloride per tablet; 60-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=betapace-af-tabs-120mg-60s-bottle-label.jpg&setid=a6a7702f-36c9-45db-b640-453dc324baee", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "盐酸索他洛尔", "en": "sotalol hydrochloride" }, "value": 120, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、频次、补服、分片指令，也不是 BETAPACE 与 BETAPACE AF、SOTYLIZE 口服液、静脉注射剂或其他抗心律失常药的换算值", "en": "labelled amount per tablet; not an individual's tablet count, frequency, catch-up or splitting instruction, and not a conversion between BETAPACE and BETAPACE AF, SOTYLIZE oral solution, intravenous sotalol or another antiarrhythmic" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 60, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-02", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "current_regulatory_listing_not_live_stock", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 60, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "白色", "en": "white" }, "shape": { "zh": "胶囊形／椭圆形刻痕片", "en": "capsule-shaped or oval scored tablet" }, "imprint": "BHCP;120;MG", "scoreStatus": "scored_appearance_clue_not_self_split_permission", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_2133e5eac8c74c36", "label": "DailyMed（NLM）：BETAPACE／BETAPACE AF 盐酸索他洛尔 80／120／160 mg 当前美国原品牌标签、六个 NDC 与六个准确包装面板（NDA 019865／021151；2024-12 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a6a7702f-36c9-45db-b640-453dc324baee", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-betapace-af-sotalol-160mg-60-tablet-bottle-ndc-8310701060", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国原品牌标签（2024-12-16 更新；Rev. 8/24）", "en": "Current U.S. originator-brand DailyMed label (updated 16 Dec 2024; Rev. 8/24)" }, "dosageForm": { "zh": "BETAPACE AF 盐酸索他洛尔刻痕口服片", "en": "BETAPACE AF scored sotalol hydrochloride oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 83107-010-60", "pouchCode": null, "applicationNumber": "NDA 021151", "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片盐酸索他洛尔 160 mg；60 片瓶装", "en": "160 mg sotalol hydrochloride per tablet; 60-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=betapace-af-tabs-160mg-60s-bottle-label.jpg&setid=a6a7702f-36c9-45db-b640-453dc324baee", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "盐酸索他洛尔", "en": "sotalol hydrochloride" }, "value": 160, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、频次、补服、分片指令，也不是 BETAPACE 与 BETAPACE AF、SOTYLIZE 口服液、静脉注射剂或其他抗心律失常药的换算值", "en": "labelled amount per tablet; not an individual's tablet count, frequency, catch-up or splitting instruction, and not a conversion between BETAPACE and BETAPACE AF, SOTYLIZE oral solution, intravenous sotalol or another antiarrhythmic" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 60, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-02", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "current_regulatory_listing_not_live_stock", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 60, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "白色", "en": "white" }, "shape": { "zh": "胶囊形／椭圆形刻痕片", "en": "capsule-shaped or oval scored tablet" }, "imprint": "BHCP;160;MG", "scoreStatus": "scored_appearance_clue_not_self_split_permission", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_2133e5eac8c74c36", "label": "DailyMed（NLM）：BETAPACE／BETAPACE AF 盐酸索他洛尔 80／120／160 mg 当前美国原品牌标签、六个 NDC 与六个准确包装面板（NDA 019865／021151；2024-12 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a6a7702f-36c9-45db-b640-453dc324baee", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-betapace-sotalol-80mg-100-tablet-bottle-ndc-8310700510", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=betapace-tabs-80mg-100s-bottle-label.jpg&setid=a6a7702f-36c9-45db-b640-453dc324baee", "alt": "Legacy Pharma BETAPACE 盐酸索他洛尔 80 mg、NDC 83107-005-10、100 片瓶装的 DailyMed 官方原品牌标签面板", "archiveMarket": "美国", "labelVersion": "DailyMed 当前美国原品牌标签（2024-12 更新）", "presentation": "BETAPACE 80 mg：浅蓝色胶囊形刻痕片，印有 BETAPACE／80 MG；NDC 83107-005-10，100 片瓶装。", "notice": "此图只对应 BETAPACE 80 mg、NDC 83107-005-10。BETAPACE AF 为白色患者包装；其他规格、口服液、注射剂、仿制品或其他市场不能从此图外推。本图不用于鉴定真伪。", "source": { "id": "src_2133e5eac8c74c36", "label": "DailyMed（NLM）：BETAPACE／BETAPACE AF 盐酸索他洛尔 80／120／160 mg 当前美国原品牌标签、六个 NDC 与六个准确包装面板（NDA 019865／021151；2024-12 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a6a7702f-36c9-45db-b640-453dc324baee", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "BETAPACE／索他洛尔说明书放大阅读：先看黑框警告、QT、肾功能与准确品牌系列", "en": "BETAPACE / sotalol enlarged label: boxed warning, QT, kidney function and exact brand family first" }, "summary": { "zh": "80／120／160 mg 是每片含量；BETAPACE 的 100 Tablets 和 BETAPACE AF 的 60 tablets 是整瓶片数。两个系列均有刻痕，但刻痕只属于准确产品的外观与标签线索，不自动构成自行掰片、减量或换药许可。", "en": "The 80, 120 and 160 mg figures are amounts per tablet. BETAPACE 100 Tablets and BETAPACE AF 60 tablets are bottle counts. Both families are scored, but a score is an exact-product appearance and label clue, not automatic permission to split, reduce or switch." }, "checks": [ { "zh": "黑框警告指出索他洛尔可因 QT 延长引起危及生命的室性心动过速；开始或重新开始用药需要可连续心电监护和心脏复苏的医疗环境，并按肌酐清除率调整给药间隔。网页不能把这些专业监护要求变成家庭加减量表。", "en": "The boxed warning states that sotalol can cause life-threatening ventricular tachycardia associated with QT prolongation. Initiation or reinitiation requires a facility with continuous ECG monitoring and cardiac resuscitation, with dosing interval based on creatinine clearance. The site cannot turn these professional monitoring requirements into a home adjustment table." }, { "zh": "低心率（心动过缓）、房室传导阻滞、低血压、心衰、头晕或晕厥可能增加跌倒和急性风险。严重晕厥、心悸伴不适、胸痛、呼吸困难、抽搐或意识异常应使用当地急救；不要等待网页判断。", "en": "Bradycardia, atrioventricular block, hypotension, heart failure, dizziness or syncope can increase fall and acute risk. Severe fainting, symptomatic palpitations, chest pain, breathing difficulty, seizure or altered awareness needs local emergency care; do not wait for a webpage to decide." }, { "zh": "严重腹泻、呕吐、异常出汗、食欲明显下降或过度口渴可能改变钾镁等电解质并影响致心律失常风险。老人、肾功能变化或同时用利尿剂者应及时让临床团队核对，而不是自行补钾、补镁、停药或补服。", "en": "Severe diarrhoea, vomiting, unusual sweating, markedly reduced appetite or excessive thirst can change electrolytes such as potassium and magnesium and affect proarrhythmic risk. Older adults, changing kidney function or co-use of a diuretic needs timely clinical review, not self-supplementation, stopping or catch-up dosing." }, { "zh": "标签要求避免与 I 类或 III 类抗心律失常药及其他延长 QT 的药自行合用；地高辛、维拉帕米／地尔硫䓬、其他 β 阻滞剂或可乐定可能进一步影响心率、血压或心功能。看到共同药名时，不要自行错开、轮换或先停其中一种。", "en": "The label says to avoid self-co-use with Class I or III antiarrhythmics and other QT-prolonging medicines. Digoxin, verapamil/diltiazem, another beta blocker or clonidine can further affect heart rate, pressure or cardiac function. Do not self-space, alternate or choose one to stop when these names appear together." }, { "zh": "含氧化铝或氢氧化镁的抗酸药可降低索他洛尔暴露；标签给出专属时间边界，但网页不根据一个成分名自动生成个人错开时间。请让药师核对实际抗酸药、处方、肾功能和全部药单。", "en": "Antacids containing aluminium oxide or magnesium hydroxide can reduce sotalol exposure. The label provides a product-specific timing boundary, but the site does not auto-generate an individual separation schedule from an ingredient name. Have the actual antacid, prescription, kidney function and full list reviewed." }, { "zh": "说明书明确漏服后不要用下一次加倍补偿；本页只呈现这一标签警示，不计算任何人的下一次时间。索他洛尔属于高风险抗心律失常药，漏服、停药或供应中断应及时联系开方团队。", "en": "The label explicitly says not to double the next dose to compensate for a missed dose. This page presents that warning but calculates no individual's next time. Sotalol is a higher-risk antiarrhythmic; missed doses, interruption or supply gaps need prompt contact with the prescribing team." } ], "source": { "id": "src_2133e5eac8c74c36", "label": "DailyMed（NLM）：BETAPACE／BETAPACE AF 盐酸索他洛尔 80／120／160 mg 当前美国原品牌标签、六个 NDC 与六个准确包装面板（NDA 019865／021151；2024-12 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a6a7702f-36c9-45db-b640-453dc324baee", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "索他洛尔怎样起作用：同时具有 β 受体阻滞与延长心肌动作电位的作用", "en": "How sotalol works: beta blockade together with cardiac action-potential prolongation" }, "summary": { "zh": "标签将索他洛尔描述为兼具 Vaughan Williams II 类 β 受体阻滞和 III 类延长心肌动作电位作用的抗心律失常药。这有助理解为什么心率、QT、电解质、肾功能和其他药必须一起看，但不能从机制决定个人能否使用或怎样调整。", "en": "The label describes sotalol as an antiarrhythmic with both Vaughan Williams Class II beta-blocking and Class III cardiac action-potential-prolonging properties. This helps explain why heart rate, QT, electrolytes, kidney function and other medicines must be reviewed together, but mechanism cannot decide individual suitability or adjustment." }, "checks": [ { "zh": "它具有 β 阻滞作用，不代表可与美托洛尔、比索洛尔、阿替洛尔、普萘洛尔、卡维地洛或奈必洛尔按 mg 换算、叠加或轮换。", "en": "Its beta-blocking action does not permit milligram conversion, combination or alternation with metoprolol, bisoprolol, atenolol, propranolol, carvedilol or nebivolol." }, { "zh": "它也具有延长动作电位／QT 的作用，不代表可与胺碘酮、氟卡尼、普罗帕酮或其他抗心律失常药自行比较强弱、组合或替换。", "en": "Its action-potential/QT effect likewise does not permit self-comparison, combination or substitution with amiodarone, flecainide, propafenone or another antiarrhythmic." }, { "zh": "索他洛尔主要经肾脏清除，说明书要求按肾功能安排专业给药间隔。作用机制、一次心率或一个肌酐值都不能由网页转换成个人片数或频次。", "en": "Sotalol is cleared mainly by the kidneys, and the label requires professional dosing-interval decisions based on renal function. Mechanism, one heart-rate reading or one creatinine value cannot be converted by the site into an individual's tablet count or frequency." } ], "source": { "id": "src_2133e5eac8c74c36", "label": "DailyMed（NLM）：BETAPACE／BETAPACE AF 盐酸索他洛尔 80／120／160 mg 当前美国原品牌标签、六个 NDC 与六个准确包装面板（NDA 019865／021151；2024-12 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a6a7702f-36c9-45db-b640-453dc324baee", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "BETAPACE / BETAPACE AF", "generic": "盐酸索他洛尔片", "dosageFormClass": "BETAPACE 与 BETAPACE AF 都含盐酸索他洛尔，但属于不同 NDA、适应证标签与患者包装路径；SOTYLIZE 口服液、静脉注射剂、其他品牌或仿制品也是不同准确产品。共同成分或相同 mg 不建立自行换算、轮换、叠加、补服、分片或替换结论。" }, "labelSource": { "id": "src_2133e5eac8c74c36", "label": "DailyMed（NLM）：BETAPACE／BETAPACE AF 盐酸索他洛尔 80／120／160 mg 当前美国原品牌标签、六个 NDC 与六个准确包装面板（NDA 019865／021151；2024-12 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a6a7702f-36c9-45db-b640-453dc324baee", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, "productRoutes": [ { "source": { "id": "src_2133e5eac8c74c36", "label": "DailyMed（NLM）：BETAPACE／BETAPACE AF 盐酸索他洛尔 80／120／160 mg 当前美国原品牌标签、六个 NDC 与六个准确包装面板（NDA 019865／021151；2024-12 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a6a7702f-36c9-45db-b640-453dc324baee", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-09-02", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_cf19c076f73ee17a", "label": "FDA：BETAPACE／BETAPACE AF 盐酸索他洛尔处方标签（NDA 019865／021151；2021-06 版本）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/019865s022lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_regulatory_document", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-09-02", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_3d17358ce65b1cf8", "label": "FDA Orange Book 第 46 版（2026）：BETAPACE／BETAPACE AF 盐酸索他洛尔口服片的 RLD、RS、规格、NDA 与批准日期", "url": "https://www.fda.gov/media/71474/download", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-09-02", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_25b00eef6caf395b", "label": "FDA Orange Book 2026 年 6 月累计增补：BETAPACE NDA 019865 活跃／停市行状态变更记录", "url": "https://www.fda.gov/media/72973/download", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-09-02", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-09-02", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "BETAPACE／BETAPACE AF 是盐酸索他洛尔原品牌口服片。80／120／160 mg 是每片含量；BETAPACE 的 100 Tablets 与 BETAPACE AF 的 60 tablets 是整瓶片数。说明书有危及生命的致心律失常黑框警告，强调 QT、心电监护、肾功能和电解质；低心率、晕厥、心衰、腹泻呕吐、跌倒以及与其他延长 QT、减慢心率或降压药同处药单时都需优先核对。网页不生成个人剂量、频次、补服、错开、停药或换药方案。", "history": "BETAPACE 于 1992 年在美国获批用于危及生命的室性心律失常。BETAPACE AF 后以独立 NDA 用于有症状房颤／房扑患者维持窦性心律。当前两个品牌系列同页呈现，但监管身份、包装颜色、瓶装数量与标签用途仍须分别阅读；它们不能被共同通用名自动合并。", "sourceDocuments": [ { "id": "src_2133e5eac8c74c36", "label": "DailyMed（NLM）：BETAPACE／BETAPACE AF 盐酸索他洛尔 80／120／160 mg 当前美国原品牌标签、六个 NDC 与六个准确包装面板（NDA 019865／021151；2024-12 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a6a7702f-36c9-45db-b640-453dc324baee", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, { "id": "src_cf19c076f73ee17a", "label": "FDA：BETAPACE／BETAPACE AF 盐酸索他洛尔处方标签（NDA 019865／021151；2021-06 版本）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/019865s022lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_regulatory_document", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, { "id": "src_3d17358ce65b1cf8", "label": "FDA Orange Book 第 46 版（2026）：BETAPACE／BETAPACE AF 盐酸索他洛尔口服片的 RLD、RS、规格、NDA 与批准日期", "url": "https://www.fda.gov/media/71474/download", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, { "id": "src_25b00eef6caf395b", "label": "FDA Orange Book 2026 年 6 月累计增补：BETAPACE NDA 019865 活跃／停市行状态变更记录", "url": "https://www.fda.gov/media/72973/download", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" } ], "applicationNumber": "BETAPACE NDA 019865；BETAPACE AF NDA 021151", "approvalTimeline": [ { "date": "1992-10-30", "title": { "zh": "BETAPACE 在美国首次获批", "en": "Initial U.S. approval of BETAPACE" }, "detail": { "zh": "FDA Orange Book 记录 NDA 019865 的 BETAPACE 于 1992 年获批，并保留为原研/RLD 监管身份。", "en": "The FDA Orange Book records 1992 approval of BETAPACE under NDA 019865 and retains its originator/RLD regulatory identity." }, "source": { "id": "src_3d17358ce65b1cf8", "label": "FDA Orange Book 第 46 版（2026）：BETAPACE／BETAPACE AF 盐酸索他洛尔口服片的 RLD、RS、规格、NDA 与批准日期", "url": "https://www.fda.gov/media/71474/download", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" } }, { "date": "2000-02-22", "title": { "zh": "BETAPACE AF 80／120／160 mg 获批", "en": "Approval of BETAPACE AF 80/120/160 mg" }, "detail": { "zh": "BETAPACE AF 通过独立 NDA 021151 建立房颤／房扑相关标签与患者包装路径。", "en": "BETAPACE AF established its AFIB/AFL labelling and patient-pack route under separate NDA 021151." }, "source": { "id": "src_3d17358ce65b1cf8", "label": "FDA Orange Book 第 46 版（2026）：BETAPACE／BETAPACE AF 盐酸索他洛尔口服片的 RLD、RS、规格、NDA 与批准日期", "url": "https://www.fda.gov/media/71474/download", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" } }, { "date": "2024-12-16", "title": { "zh": "Legacy Pharma 当前原品牌标签更新", "en": "Current Legacy Pharma originator-brand label updated" }, "detail": { "zh": "当前 DailyMed 页面列出 BETAPACE 与 BETAPACE AF 各三个规格、共六个准确包装面板。", "en": "The current DailyMed page lists three strengths for each of BETAPACE and BETAPACE AF, with six exact package panels in total." }, "source": { "id": "src_2133e5eac8c74c36", "label": "DailyMed（NLM）：BETAPACE／BETAPACE AF 盐酸索他洛尔 80／120／160 mg 当前美国原品牌标签、六个 NDC 与六个准确包装面板（NDA 019865／021151；2024-12 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a6a7702f-36c9-45db-b640-453dc324baee", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" } }, { "date": "2026-06", "title": { "zh": "Orange Book 累计增补记录 BETAPACE 状态更新", "en": "Orange Book cumulative supplement recorded BETAPACE status updates" }, "detail": { "zh": "该增补用于核对监管列表变化；它不等于实时库存、处方变化或个体替换许可。", "en": "The supplement supports regulatory-list reconciliation; it is not live inventory, a prescription change or individual substitution permission." }, "source": { "id": "src_25b00eef6caf395b", "label": "FDA Orange Book 2026 年 6 月累计增补：BETAPACE NDA 019865 活跃／停市行状态变更记录", "url": "https://www.fda.gov/media/72973/download", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" } } ], "marketStatus": [ { "market": { "zh": "美国 BETAPACE", "en": "United States — BETAPACE" }, "status": { "zh": "当前原品牌口服片标签", "en": "Current originator-brand oral-tablet label" }, "detail": { "zh": "NDA 019865；当前准确包装显示 80／120／160 mg，各 100 片瓶装。", "en": "NDA 019865; current exact packs show 80, 120 and 160 mg in 100-tablet bottles." } }, { "market": { "zh": "美国 BETAPACE AF", "en": "United States — BETAPACE AF" }, "status": { "zh": "当前独立 NDA 患者包装", "en": "Current separate-NDA patient pack" }, "detail": { "zh": "NDA 021151；当前准确包装显示 80／120／160 mg，各 60 片瓶装。", "en": "NDA 021151; current exact packs show 80, 120 and 160 mg in 60-tablet bottles." } }, { "market": { "zh": "口服液、静脉注射剂及其他品牌", "en": "Oral solution, intravenous product and other brands" }, "status": { "zh": "不同准确产品", "en": "Separate exact products" }, "detail": { "zh": "SOTYLIZE、静脉索他洛尔、SORINE 与仿制品不并入六个原品牌包装，也不建立换算。", "en": "SOTYLIZE, intravenous sotalol, SORINE and generics are not merged into the six originator-brand packs and no conversion is established." } }, { "market": { "zh": "美国以外市场", "en": "Markets outside the United States" }, "status": { "zh": "本档案未确认当地品牌、包装或供应", "en": "Local brand, pack and supply are not established" }, "detail": { "zh": "请按当地药监记录、现行说明书、处方和手中药盒逐项核对。", "en": "Check the local regulator, current label, prescription and pack in hand item by item." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "100 Tablets／60 tablets 是一次吃的数量吗？", "en": "Does 100 Tablets or 60 tablets mean the amount to take at once?" }, "answer": { "zh": "不是。它们是整瓶片数；80／120／160 mg 才是每片标签含量。网页不会把瓶装数量或 mg 变成个人片数或频次。", "en": "No. They are bottle counts; 80/120/160 mg is the labelled amount per tablet. The site does not turn a bottle count or milligrams into an individual's tablet count or frequency." } }, { "question": { "zh": "BETAPACE 和 BETAPACE AF 成分一样，可以自己替换吗？", "en": "BETAPACE and BETAPACE AF share an ingredient; can they be self-substituted?" }, "answer": { "zh": "不能。它们属于不同 NDA、适应证标签与患者包装路径。即使规格数字相同，也必须由开方团队和药师按准确处方核对。", "en": "No. They have separate NDAs, indication labelling and patient-pack pathways. Even when a strength number matches, the exact prescription needs review by the prescribing team and pharmacist." } }, { "question": { "zh": "漏服后能不能下一次吃双倍？", "en": "Can the next dose be doubled after a missed dose?" }, "answer": { "zh": "当前标签明确警示不要用下一次加倍补偿。网页不计算下一次时间；索他洛尔属于高风险抗心律失常药，漏服或中断应及时联系开方团队。", "en": "The current label explicitly says not to double the next dose to compensate. The site calculates no next time; sotalol is a higher-risk antiarrhythmic and a missed dose or interruption needs prompt contact with the prescribing team." } }, { "question": { "zh": "有刻痕就可以自己掰半吗？", "en": "Does the score mean the tablet can be self-halved?" }, "answer": { "zh": "不能这样推断。刻痕是准确产品的外观与标签字段；是否可分、分后剂量与处方是否匹配都必须按具体规格、现行标签、处方和药师复核。", "en": "No. A score is an exact-product appearance and label field. Splitting, the resulting amount and prescription fit require the exact strength, current label, prescription and pharmacist review." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "dosage-forms-are-part-of-medicine-identity", "same-class-is-not-same-medicine", "interactions-are-not-a-home-scheduling-problem" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/betapace-sotalol/", "en": "https://origindrug.com/en/drugs/betapace-sotalol/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "atorvastatin-lipitor", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-30", "status": "published_traceable_archive" }, "names": { "brand": "Lipitor", "generic": "阿托伐他汀", "aliases": [ "立普妥", "立普妥®", "阿托伐他汀钙片", "リピトール", "atorvastatin", "atorvastatin calcium" ], "marketBrandNames": [ { "name": "立普妥®", "market": { "zh": "中国大陆", "en": "Mainland China" }, "evidenceStatus": "current_first_party_leaflet", "note": { "zh": "晖致中国当前产品信息页列示立普妥［阿托伐他汀钙片］，其链接的 Version No. 20260119 企业说明书列示 10 mg、20 mg、40 mg。该企业公开资料可用于核对商品名、通用名、剂型、规格与说明书版本；不等于 NMPA 批准数据库、批准文号、准确包装、库存、可售资格或真伪鉴定。", "en": "Viatris China's current product-information page lists Lipitor (立普妥) [atorvastatin calcium tablets], and its linked first-party leaflet, Version No. 20260119, lists 10 mg, 20 mg and 40 mg. These company-published materials support checking the brand, generic name, form, strengths and leaflet version; they are not an NMPA approval-database record, approval number, exact package, stock, sale-eligibility record or authenticity determination." }, "source": { "id": "src_1bcca59c86bc4b38", "label": "晖致中国：立普妥®／阿托伐他汀钙片说明书 Version No. 20260119（25 页）", "url": "https://viatris.com.cn/-/media/project/viatris-sites/product-document/01atorvastatincalciumtablets.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "first_party_leaflet", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" } }, { "name": "リピトール", "market": { "zh": "日本", "en": "Japan" }, "evidenceStatus": "current_regulatory_record", "note": { "zh": "PMDA 当前产品页列示リピトール錠 5 mg、10 mg及阿托伐他汀成分；仅用于核对日文名称、成分、剂型和市场记录，不确认其他剂型、包装、供应、可售资格或可自行换药。", "en": "The current PMDA product page lists LIPITOR (リピトール) 5 mg and 10 mg tablets with atorvastatin; it only supports checking the Japanese name, ingredient, form and market record—not another form, pack, supply, availability or self-directed switching." }, "source": { "id": "src_deb7f792025a47d6", "label": "PMDA：リピトール錠 5 mg／10 mg 当前产品页", "url": "https://www.pmda.go.jp/PmdaSearch/rdDetail/iyaku/2189015F1023_2?user=1", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } } ], "mainlandChinaTradeNameCue": { "value": "立普妥®", "status": "discovery_cue_requires_target_market_verification", "source": { "id": "src_104aa9169b36e4d2", "label": "Pfizer China：立普妥／络活喜品牌名历史公开资料（2019）", "url": "https://www.pfizer.com.cn/zh-hans/news/press-release/619", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "first_party_release", "market": "CN", "accessStatus": "public_access_with_site_controls", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } } }, "identity": { "therapeuticArea": "心血管", "sourceArchiveMarket": "美国 DailyMed SPL v8 列示 10 mg、20 mg、40 mg、80 mg；晖致中国当前产品页及 Version No. 20260119 企业说明书列示中国大陆立普妥® 10 mg、20 mg、40 mg；日本 PMDA 当前产品记录列示リピトール錠 5 mg、10 mg。三地规格与文件必须分开阅读。", "dosageFormClass": "阿托伐他汀钙口服薄膜衣片：美国 10 mg、20 mg、40 mg、80 mg；中国大陆企业说明书 10 mg、20 mg、40 mg；日本 PMDA 5 mg、10 mg。不同市场规格不合并，也不转换为个人片数。", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "1996", "archiveSponsorText": "晖致中国当前产品页与企业说明书；Viatris Specialty LLC / DailyMed 美国公开标签；日本 PMDA 当前产品记录" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [ "CADUET", "amlodipine and atorvastatin", "amlodipine/atorvastatin" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-lipitor-tablet-10mg-ndc-58151-155-77", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v8，2026-07-15 发布", "en": "DailyMed SPL v8, published 15 Jul 2026" }, "dosageForm": { "zh": "LIPITOR 阿托伐他汀口服薄膜衣片", "en": "LIPITOR atorvastatin film-coated oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 58151-155-77", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片 10 mg；90 片瓶装", "en": "10 mg per tablet; 90-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=a60cc18b-0631-4cf0-b021-9f52224ece65&type=img&name=image-05.jpg", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "阿托伐他汀", "en": "atorvastatin" }, "value": 10, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标示量；不是个人片数或换药规则", "en": "labelled amount per tablet; not an individual's tablet count or switching rule" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 90, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-20", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 90, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "白色", "en": "white" }, "shape": { "zh": "椭圆形薄膜衣片", "en": "elliptical film-coated tablet" }, "imprint": "10 / VLE 155", "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_d6030b2d9ce833f1", "label": "DailyMed（NLM）：LIPITOR 阿托伐他汀当前美国公开标签（Viatris；SPL v8，2026-07-15 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a60cc18b-0631-4cf0-b021-9f52224ece65", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-lipitor-tablet-20mg-ndc-58151-156-77", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v8，2026-07-15 发布", "en": "DailyMed SPL v8, published 15 Jul 2026" }, "dosageForm": { "zh": "LIPITOR 阿托伐他汀口服薄膜衣片", "en": "LIPITOR atorvastatin film-coated oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 58151-156-77", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片 20 mg；90 片瓶装", "en": "20 mg per tablet; 90-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=a60cc18b-0631-4cf0-b021-9f52224ece65&type=img&name=image-06.jpg", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "阿托伐他汀", "en": "atorvastatin" }, "value": 20, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标示量；不是个人片数或换药规则", "en": "labelled amount per tablet; not an individual's tablet count or switching rule" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 90, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-20", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 90, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "白色", "en": "white" }, "shape": { "zh": "椭圆形薄膜衣片", "en": "elliptical film-coated tablet" }, "imprint": "20 / VLE 156", "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_d6030b2d9ce833f1", "label": "DailyMed（NLM）：LIPITOR 阿托伐他汀当前美国公开标签（Viatris；SPL v8，2026-07-15 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a60cc18b-0631-4cf0-b021-9f52224ece65", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-lipitor-tablet-40mg-ndc-58151-157-77", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v8，2026-07-15 发布", "en": "DailyMed SPL v8, published 15 Jul 2026" }, "dosageForm": { "zh": "LIPITOR 阿托伐他汀口服薄膜衣片", "en": "LIPITOR atorvastatin film-coated oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 58151-157-77", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片 40 mg；90 片瓶装", "en": "40 mg per tablet; 90-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=a60cc18b-0631-4cf0-b021-9f52224ece65&type=img&name=image-07.jpg", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "阿托伐他汀", "en": "atorvastatin" }, "value": 40, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标示量；不是个人片数或换药规则", "en": "labelled amount per tablet; not an individual's tablet count or switching rule" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 90, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-20", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 90, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "白色", "en": "white" }, "shape": { "zh": "椭圆形薄膜衣片", "en": "elliptical film-coated tablet" }, "imprint": "40 / VLE 157", "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_d6030b2d9ce833f1", "label": "DailyMed（NLM）：LIPITOR 阿托伐他汀当前美国公开标签（Viatris；SPL v8，2026-07-15 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a60cc18b-0631-4cf0-b021-9f52224ece65", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-lipitor-tablet-80mg-ndc-58151-158-77", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v8，2026-07-15 发布", "en": "DailyMed SPL v8, published 15 Jul 2026" }, "dosageForm": { "zh": "LIPITOR 阿托伐他汀口服薄膜衣片", "en": "LIPITOR atorvastatin film-coated oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 58151-158-77", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片 80 mg；90 片瓶装", "en": "80 mg per tablet; 90-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=a60cc18b-0631-4cf0-b021-9f52224ece65&type=img&name=image-08.jpg", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "阿托伐他汀", "en": "atorvastatin" }, "value": 80, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标示量；不是个人片数或换药规则", "en": "labelled amount per tablet; not an individual's tablet count or switching rule" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 90, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-20", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 90, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "白色", "en": "white" }, "shape": { "zh": "椭圆形薄膜衣片", "en": "elliptical film-coated tablet" }, "imprint": "80 / VLE 158", "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_d6030b2d9ce833f1", "label": "DailyMed（NLM）：LIPITOR 阿托伐他汀当前美国公开标签（Viatris；SPL v8，2026-07-15 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a60cc18b-0631-4cf0-b021-9f52224ece65", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-lipitor-tablet-10mg-ndc-58151-155-77", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=a60cc18b-0631-4cf0-b021-9f52224ece65&type=img&name=image-05.jpg", "alt": "LIPITOR 阿托伐他汀在美国 DailyMed Viatris 当前公开标签中的 10 mg、NDC 58151-155-77、90 片瓶装展示面", "archiveMarket": "美国", "labelVersion": "DailyMed SPL v8（2026-07-15 发布）", "presentation": "LIPITOR 阿托伐他汀：每片 10 mg，NDC 58151-155-77，90 片瓶装展示面。", "notice": "此图只对应美国 DailyMed 当前标签中的 LIPITOR、阿托伐他汀 10 mg、NDC 58151-155-77 与 90 片瓶装。原始公开标签图在 GTIN／LOT／EXP 旁含黑色遮蔽区域，用于覆盖可变批号和效期字段，并非网页图片加载错误。图片只帮助核对品牌、通用名、每片标示量、片剂、包装数量与来源；不用于鉴定真伪，也不证明 20 mg、40 mg、80 mg、其他包装、其他市场、当前可得性、原研身份、可替代性或任何个人的片数、联用、分片、开始、停用或换药方案。", "source": { "id": "src_d6030b2d9ce833f1", "label": "DailyMed（NLM）：LIPITOR 阿托伐他汀当前美国公开标签（Viatris；SPL v8，2026-07-15 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a60cc18b-0631-4cf0-b021-9f52224ece65", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "Lipitor 说明书放大阅读：不要把“同类药”当成可自行叠加", "en": "Lipitor label reading: a same-class medicine is not an automatic add-on" }, "summary": { "zh": "本模块把中国大陆 Version No. 20260119 企业说明书、美国当前标签与日本 PMDA 记录分开阅读，帮助识别品牌、通用名、每片规格、辅料和包装变化；它不判断个人应服几片、是否转换或能否与另一种他汀合用。", "en": "This module keeps the Mainland China first-party leaflet Version No. 20260119, the current U.S. label and the Japan PMDA record separate, helping readers check the brand, generic name, strength per tablet, excipients and packaging changes. It does not decide a personal tablet count, switch or combination with another statin." }, "checks": [ { "zh": "先把商品名 Lipitor／立普妥®、通用名阿托伐他汀钙片、每片标示强度、口服薄膜衣片和目标市场一起核对。中国大陆企业说明书列 10 mg、20 mg、40 mg，美国当前标签另有 80 mg，日本 PMDA 另有 5 mg；这些规格不能跨市场拼成同一套产品。", "en": "Check Lipitor / 立普妥®, atorvastatin calcium tablets, the stated strength per tablet, oral film-coated form and target market together. The Mainland China first-party leaflet lists 10 mg, 20 mg and 40 mg; the current U.S. label also has 80 mg, while Japan PMDA also has 5 mg. These market-specific strengths must not be merged into one product set." }, { "zh": "中国大陆 Version No. 20260119 企业说明书列示碳酸钙、微晶纤维素、乳糖、交联羧甲纤维素钠、聚山梨酯 80、羟丙纤维素、硬脂酸镁及包衣相关成分等辅料。辅料表用于核对手中产品和向医生或药师提出过敏、耐受或相互作用问题；不能据此断言另一厂牌疗效更差、把 40 mg 自动拆成两片 20 mg，或给出个人片数。", "en": "The Mainland China first-party leaflet Version No. 20260119 lists excipients including calcium carbonate, microcrystalline cellulose, lactose, croscarmellose sodium, polysorbate 80, hydroxypropyl cellulose, magnesium stearate and coating-related ingredients. The excipient list helps check the exact product and frame allergy, tolerability or interaction questions for a clinician or pharmacist; it does not prove another manufacturer is less effective, turn 40 mg automatically into two 20 mg tablets, or provide a personal tablet count." }, { "zh": "晖致中国包装更新声明说明，Pfizer 与 VIATRIS 标识、企业名称、片剂文字和刻痕等可能随包装切换而变化，旧版与新版包装也可能在过渡期并存。外观不同不能单独证明是假药；应继续核对完整药盒、说明书版本、批准文号和官方查询入口。", "en": "Viatris China's packaging-update statement says Pfizer and VIATRIS branding, company names, tablet text and score may change during the packaging transition, and older and newer packs may coexist. A different appearance alone does not prove a medicine is counterfeit; continue by checking the complete pack, leaflet version, approval number and official lookup route." }, { "zh": "阿托伐他汀和瑞舒伐他汀都属于他汀类。没有开方医生或药师明确方案时，不应自行同日叠加、隔天轮换、把一盒替换另一盒，或因感觉变化自行加减；这类问题要连同全部用药清单一起复核。", "en": "Atorvastatin and rosuvastatin are both statins. Without a specific plan from the prescriber or pharmacist, do not self-combine them on the same day, alternate them, replace one pack with the other, or change use based on a feeling; review the complete medicine list instead." }, { "zh": "标签中的强度是每片产品身份的一部分，不是“每天该吃几片”的答案。任何强度、用药时间、能否掰开或与食物同服的问题，都要回到这一个市场、这一个版本、这一个产品的现行标签和处方。", "en": "The labelled strength is part of a tablet's identity, not an answer to “how many tablets per day.” Questions about strength, timing, splitting or food must go back to the current label and prescription for this exact product, version and market." }, { "zh": "若已做过药物基因检测，可带着原始报告与药品清单请专业人员解释其是否与当前治疗有关；网页不会据此建议每个人做筛查，也不会把基因结果替代肾肝功能、既往反应、合并疾病和联用药物的核对。", "en": "If pharmacogenomic testing has already been done, bring the original report and medicine list to a professional to ask whether it is relevant. This page does not recommend universal screening or let genetic results replace checks of kidney/liver function, prior reactions, conditions and co-medications." } ], "source": { "id": "src_1bcca59c86bc4b38", "label": "晖致中国：立普妥®／阿托伐他汀钙片说明书 Version No. 20260119（25 页）", "url": "https://viatris.com.cn/-/media/project/viatris-sites/product-document/01atorvastatincalciumtablets.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "first_party_leaflet", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "阿托伐他汀怎样起作用：它影响胆固醇合成路径中的一个酶", "en": "How atorvastatin works: it acts on one enzyme in the cholesterol-synthesis pathway" }, "summary": { "zh": "FDA 标签在临床药理部分将阿托伐他汀描述为 HMG‑CoA 还原酶的选择性、竞争性抑制剂。它是对药物作用路径的解释，不是对任何个人 LDL‑C 变化、心血管风险、适用性或剂量的承诺。", "en": "In Clinical Pharmacology, the FDA label describes atorvastatin as a selective, competitive inhibitor of HMG‑CoA reductase. This explains a drug-action pathway; it is not a promise of any individual's LDL‑C change, cardiovascular risk, suitability or dose." }, "checks": [ { "zh": "可把 HMG‑CoA 还原酶理解为胆固醇合成路径中的一个关键“步骤”。标签描述的抑制作用与肝脏 LDL 受体等后续变化有关；这解释了为何它被归入他汀类，但不能替代血脂检查、风险评估或处方复核。", "en": "HMG‑CoA reductase can be read as one key “step” in cholesterol synthesis. The label links inhibition with downstream changes including hepatic LDL receptors; that explains its statin class, but does not replace lipid testing, risk assessment or prescription review." }, { "zh": "“同为他汀、都影响同一路径”不等于可把阿托伐他汀与瑞舒伐他汀自行叠加或交替。不同产品、强度、相互作用、肾肝功能、既往反应和目标市场标签都需要一起由专业人员核对。", "en": "“Both are statins and affect the same pathway” does not permit self-combining or alternating atorvastatin and rosuvastatin. Exact products, strengths, interactions, kidney/liver function, prior reactions and target-market labels must be reviewed together by a professional." }, { "zh": "药物基因组结果在少数场景可帮助专业人员理解暴露或不良反应风险，但机制本身不表示每个人都应做全基因筛查。已有报告应与完整药单和临床资料一并解释，不能作为自行开始、停用或换药的依据。", "en": "Pharmacogenomic results can help professionals interpret exposure or adverse-effect risk in defined situations, but the mechanism itself does not mean everyone should have broad genetic screening. An existing report must be interpreted with the full medicine list and clinical information, not used to self-start, stop or switch." } ], "source": { "id": "src_defe48d290569ed6", "label": "FDA：Lipitor 2024-04 处方信息（Clinical Pharmacology）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/020702s081lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "Lipitor", "generic": "阿托伐他汀", "dosageFormClass": "阿托伐他汀钙口服薄膜衣片：美国 10 mg、20 mg、40 mg、80 mg；中国大陆企业说明书 10 mg、20 mg、40 mg；日本 PMDA 5 mg、10 mg。不同市场规格不合并，也不转换为个人片数。" }, "labelSource": { "id": "src_1bcca59c86bc4b38", "label": "晖致中国：立普妥®／阿托伐他汀钙片说明书 Version No. 20260119（25 页）", "url": "https://viatris.com.cn/-/media/project/viatris-sites/product-document/01atorvastatincalciumtablets.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "first_party_leaflet", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "productRoutes": [ { "source": { "id": "src_1bcca59c86bc4b38", "label": "晖致中国：立普妥®／阿托伐他汀钙片说明书 Version No. 20260119（25 页）", "url": "https://viatris.com.cn/-/media/project/viatris-sites/product-document/01atorvastatincalciumtablets.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "first_party_leaflet", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "status": "manufacturer_public_label_verified", "authority": { "zh": "晖致中国", "en": "Viatris China" }, "market": { "zh": "中国大陆", "en": "Mainland China" }, "recordType": { "zh": "企业公开说明书或产品资料", "en": "Manufacturer public leaflet or product material" }, "reviewedAt": "2026-08-30", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_defe48d290569ed6", "label": "FDA：Lipitor 2024-04 处方信息", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/020702s081lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_d6030b2d9ce833f1", "label": "DailyMed（NLM）：LIPITOR 阿托伐他汀当前美国公开标签（Viatris；SPL v8，2026-07-15 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a60cc18b-0631-4cf0-b021-9f52224ece65", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_deb7f792025a47d6", "label": "PMDA：リピトール錠 5 mg／10 mg 当前产品页", "url": "https://www.pmda.go.jp/PmdaSearch/rdDetail/iyaku/2189015F1023_2?user=1", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "status": "product_level_public_record_verified", "authority": { "zh": "PMDA", "en": "PMDA" }, "market": { "zh": "日本", "en": "Japan" }, "recordType": { "zh": "监管产品记录", "en": "Regulatory product record" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "manufacturer_public_label_verified", "authority": { "zh": "晖致中国", "en": "Viatris China" }, "market": { "zh": "中国大陆", "en": "Mainland China" }, "recordType": { "zh": "企业公开说明书或产品资料", "en": "Manufacturer public leaflet or product material" }, "reviewedAt": "2026-08-30", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [ { "id": "fda-2021-statin-pregnancy-breastfeeding-safety-communication", "issuedAt": "2021-07-20", "status": "fda_class_safety_communication", "title": { "zh": "FDA 药物安全通讯：他汀类药物在妊娠与哺乳期的标签变更", "en": "FDA Drug Safety Communication: labelling changes for statins in pregnancy and breastfeeding" }, "summary": { "zh": "FDA 于 2021-07-20 就整个他汀类发布安全通讯，明确列出 Lipitor（阿托伐他汀）和 Crestor（瑞舒伐他汀）。该通讯涉及美国处方信息中妊娠与哺乳相关警语的监管变更和个体化获益/风险判断；它不等于任何个人可以据此自行开始、停止、替换或调整药物。妊娠、疑似妊娠或哺乳相关问题应结合手中产品、目标市场现行说明书和开方团队意见核对。", "en": "On 2021-07-20, FDA issued a class Drug Safety Communication that explicitly lists Lipitor (atorvastatin) and Crestor (rosuvastatin). It concerns U.S. prescribing-information changes around pregnancy and breastfeeding and individualized benefit-risk review; it does not support self-starting, stopping, switching or adjusting any individual medicine. Pregnancy, suspected pregnancy or breastfeeding questions require the exact product, current target-market label and the prescribing team." }, "source": { "id": "src_e5fb970c597c7f50", "label": "FDA：2021-07-20 他汀类药物妊娠与哺乳期药物安全通讯", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/fda-requests-removal-strongest-warning-against-using-cholesterol-lowering-statins-during-pregnancy", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-2023-statin-myasthenia-gravis-atorvastatin", "issuedAt": "2023-02-06", "status": "ema_prac_product_information_signal", "title": { "zh": "EMA PRAC 产品信息安全信号：Lipitor（atorvastatin）所在他汀类与重症肌无力／眼肌型重症肌无力", "en": "EMA PRAC product-information signal: statins including Lipitor (atorvastatin) and myasthenia gravis / ocular myasthenia" }, "summary": { "zh": "EMA 药物警戒风险评估委员会（PRAC）于 2023-02-06 发布的产品信息措辞摘录，把 Lipitor（atorvastatin）列入他汀类范围。该文件说明：少数报告提示，他汀类可诱发新发或加重既有重症肌无力或眼肌型重症肌无力；同一种或不同他汀再次使用后也报告过症状复发。它是欧盟产品信息更新的、特定日期的信号沟通，不表示手中任何 Lipitor 包装、其他市场或任何个人已发生该问题，也不能据此自行停药、换药、减量、加量或交替服用。出现新的或加重的肌无力相关疑问，应带上实际包装和完整用药清单尽快联系开方团队或药师；紧急症状应使用当地急救服务。", "en": "In its product-information wording extract dated 2023-02-06, EMA's Pharmacovigilance Risk Assessment Committee (PRAC) includes Lipitor (atorvastatin) within the statin class. The document says that, in a few reported cases, statins may induce new-onset or aggravate pre-existing myasthenia gravis or ocular myasthenia, and that recurrence after re-administration of the same or a different statin has been reported. This is a dated EU product-information signal; it does not mean that any Lipitor pack, another market, or any individual has this problem, and it does not support self-stopping, switching, reducing, increasing, or alternating treatment. New or worsening muscle-weakness questions need the actual pack and complete medicine list reviewed promptly by the prescribing team or pharmacist; emergencies require local emergency services." }, "source": { "id": "src_0fd36b48b08adb04", "label": "EMA PRAC：2023-02-06 他汀类（含 atorvastatin、rosuvastatin）与重症肌无力产品信息安全信号", "url": "https://www.ema.europa.eu/en/documents/prac-recommendation/new-product-information-wording-extracts-prac-recommendations-signals-adopted-9-12-january-2023-prac_bg.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "regulatory_product_information_signal", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "中国大陆可从晖致当前产品页进入立普妥® Version No. 20260119 企业说明书，核对阿托伐他汀钙片 10 mg、20 mg、40 mg；美国 DailyMed 当前标签另列 10 mg、20 mg、40 mg、80 mg，日本 PMDA 另列 5 mg、10 mg。本页把三地规格、来源与包装线索分开，不把标签数字变成个人片数、换药比例、联合用药、停用或购买结论。", "history": "LIPITOR 的美国上市信息可在 Drugs@FDA 相关批准文件中追溯；中国大陆当前企业说明书版本号为 20260119。晖致中国包装更新声明说明，品牌从 Pfizer 向 VIATRIS 过渡时，旧包装与新包装可能在流通环节并存，且包装文字、企业名称、片剂文字与刻痕等会变化；外观差异本身不能用于判定真伪。CADUET（氨氯地平/阿托伐他汀）是独立复方产品，不能混入本单方档案。", "sourceDocuments": [ { "id": "src_17a2d15fb5fe843b", "label": "晖致中国：立普妥®／阿托伐他汀钙片产品信息页（2026-08-30 复核）", "url": "https://viatris.cn/products/product-information", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "first_party_product_page", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, { "id": "src_1bcca59c86bc4b38", "label": "晖致中国：立普妥®／阿托伐他汀钙片说明书 Version No. 20260119（25 页）", "url": "https://viatris.com.cn/-/media/project/viatris-sites/product-document/01atorvastatincalciumtablets.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "first_party_leaflet", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, { "id": "src_5eab1043fc8a5837", "label": "晖致中国：关于立普妥®等产品包装更新的声明（更新于 2025-04）", "url": "https://viatris.cn/newsroom/news-20240802", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "first_party_release", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, { "id": "src_defe48d290569ed6", "label": "FDA：Lipitor 2024-04 处方信息", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/020702s081lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_d6030b2d9ce833f1", "label": "DailyMed（NLM）：LIPITOR 阿托伐他汀当前美国公开标签（Viatris；SPL v8，2026-07-15 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a60cc18b-0631-4cf0-b021-9f52224ece65", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_22af65532a65996f", "label": "DailyMed（NLM）：CADUET 氨氯地平/阿托伐他汀独立美国公开标签（Viatris；SPL v2，2026-06-26 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=164394b3-d7ba-4bbf-b64b-e2dd15735ea8", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "documentRelation": "excluded_product_reference", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, { "id": "src_deb7f792025a47d6", "label": "PMDA：リピトール錠 5 mg／10 mg 当前产品页", "url": "https://www.pmda.go.jp/PmdaSearch/rdDetail/iyaku/2189015F1023_2?user=1", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } ], "applicationNumber": "NDA 020702", "approvalTimeline": [ { "date": "1996", "title": { "zh": "FDA 标签所列美国初始批准年份", "en": "Initial U.S. approval year listed in the FDA label" }, "detail": { "zh": "FDA 2024-04 LIPITOR 标签列示 Initial U.S. Approval: 1996。该历史信息不等同于其他市场的批准、现行包装、供应或可售资格。", "en": "The Apr 2024 FDA LIPITOR label lists Initial U.S. Approval: 1996. This historical information does not establish approval, current packaging, supply or sale eligibility in another market." }, "source": { "id": "src_defe48d290569ed6", "label": "FDA: Lipitor prescribing information", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/020702s081lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, { "date": "2024-04", "title": { "zh": "FDA 标签档案版本", "en": "FDA label archive version" }, "detail": { "zh": "本页链接 2024-04 的 FDA 标签档案，作为追溯入口；美国当前产品身份与包装面板另以 DailyMed SPL v8 核对。", "en": "This page links the Apr 2024 FDA label archive as a traceability entry point; current U.S. product identity and package panels are checked separately against DailyMed SPL v8." }, "source": { "id": "src_defe48d290569ed6", "label": "FDA: Lipitor prescribing information", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/020702s081lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, { "date": "2025-04", "title": { "zh": "晖致中国更新立普妥®包装变更声明", "en": "Viatris China updated its Lipitor packaging-change statement" }, "detail": { "zh": "声明说明 Pfizer 与 VIATRIS 标识、企业名称、片剂文字和刻痕等可能随包装切换而变化，旧版与新版包装可能在过渡期并存。该信息用于解释外观变化，不构成真伪鉴定、库存或可售资格证明。", "en": "The statement says Pfizer and VIATRIS branding, company names, tablet text and score may change during the packaging transition, and older and newer packs may coexist. It explains appearance changes; it is not an authenticity determination, stock record or evidence of sale eligibility." }, "source": { "id": "src_5eab1043fc8a5837", "label": "晖致中国：关于立普妥®等产品包装更新的声明（更新于 2025-04）", "url": "https://viatris.cn/newsroom/news-20240802", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "first_party_release", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" } }, { "date": "2026-01-19", "title": { "zh": "中国大陆企业说明书 Version No. 20260119", "en": "Mainland China first-party leaflet Version No. 20260119" }, "detail": { "zh": "晖致中国当前产品信息页链接的 25 页说明书列示立普妥®、阿托伐他汀钙片及 10 mg、20 mg、40 mg，并提供辅料与外观等阅读字段。它是企业公开说明书，不替代 NMPA 批准数据库、批准文号、准确包装、库存或可售资格核验。", "en": "The 25-page leaflet linked from Viatris China's current product-information page lists Lipitor (立普妥®), atorvastatin calcium tablets and 10 mg, 20 mg and 40 mg strengths, with excipient and appearance fields. It is a first-party leaflet and does not replace an NMPA approval-database, approval-number, exact-package, stock or sale-eligibility check." }, "source": { "id": "src_1bcca59c86bc4b38", "label": "晖致中国：立普妥®／阿托伐他汀钙片说明书 Version No. 20260119（25 页）", "url": "https://viatris.com.cn/-/media/project/viatris-sites/product-document/01atorvastatincalciumtablets.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "first_party_leaflet", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "当前公开标签与四个精确包装面板已链接", "en": "Current public label and four exact package panels linked" }, "detail": { "zh": "DailyMed SPL v8 列示 10 mg、20 mg、40 mg、80 mg；不据此声称实际在售、库存或可获得性。", "en": "DailyMed SPL v8 lists 10 mg, 20 mg, 40 mg and 80 mg; this does not establish actual marketing, stock or availability." } }, { "market": { "zh": "中国大陆", "en": "Mainland China" }, "status": { "zh": "当前企业产品页与 Version No. 20260119 说明书已链接", "en": "Current first-party product page and leaflet Version No. 20260119 linked" }, "detail": { "zh": "企业资料列示立普妥®、阿托伐他汀钙片及 10 mg、20 mg、40 mg；仍需从 NMPA 官方入口另行核对批准记录、批准文号与目标产品，且不推定库存或可售资格。", "en": "The company materials list Lipitor (立普妥®), atorvastatin calcium tablets and 10 mg, 20 mg and 40 mg; the approval record, approval number and target product still require a separate NMPA check, and stock or sale eligibility is not inferred." } }, { "market": { "zh": "日本", "en": "Japan" }, "status": { "zh": "当前 PMDA 产品记录已链接", "en": "Current PMDA product record linked" }, "detail": { "zh": "PMDA 产品页列示リピトール錠 5 mg、10 mg；不把日本规格并入中国大陆或美国规格。", "en": "The PMDA product page lists LIPITOR 5 mg and 10 mg tablets; Japanese strengths are not merged into Mainland China or U.S. strengths." } }, { "market": { "zh": "欧盟", "en": "European Union" }, "status": { "zh": "待建立市场记录", "en": "Market record not established" }, "detail": { "zh": "不从美国、中国大陆企业资料或日本记录推定欧盟批准、持有人、规格、供应或可售资格。", "en": "No EU approval, holder, strength, supply or sale-eligibility inference is made from U.S., Mainland China company or Japan records." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "一天吃阿托伐他汀、一天吃瑞舒伐他汀，可以隔天轮换吗？", "en": "Can atorvastatin and rosuvastatin be alternated on different days?" }, "answer": { "zh": "不要自行隔天轮换，也不要同日各吃一颗。两者虽然都属于他汀类，但不是按药名或 mg 自动换算的同一种产品；轮换还会让漏服、重复、相互作用和不适反应更难追溯。请把两盒实际药品、处方和完整药单交给开方团队或药师确认真正的现行方案，不要自行停一种、补一种或交替使用。", "en": "Do not self-alternate them by day or take one of each on the same day. Both are statins, but they are not one product that can be converted by name or milligrams. Alternation also makes omissions, duplication, interactions and adverse symptoms harder to trace. Take both actual packs, the prescription and complete medicine list to the prescriber or pharmacist to confirm the current plan; do not self-stop one, add the other or rotate them." } }, { "question": { "zh": "为什么有些人的完整药单会让专业人员特别核对阿托伐他汀？", "en": "Why can a person's complete medicine list trigger extra atorvastatin review?" }, "answer": { "zh": "当前 LIPITOR 标签说明阿托伐他汀是 CYP3A4 和多种转运体的底物，并列出某些抗病毒药、抗真菌药、抗菌药、环孢素、吉非贝齐及大量葡萄柚汁等需要避免、限制或额外管理的情形。这解释了为什么必须看完整药单，却不能由网页据此宣布某个人“适合瑞舒伐他汀”或自行换药；准确产品、疾病、肝肾功能、既往反应和目标市场标签仍要一起判断。", "en": "The current LIPITOR label identifies atorvastatin as a substrate of CYP3A4 and several transporters and lists circumstances involving certain antivirals, antifungals, antibacterials, cyclosporine, gemfibrozil and large quantities of grapefruit juice that need avoidance, limits or added management. This explains why the complete medicine list matters, but it does not let a webpage declare that someone is ‘suited to rosuvastatin’ or self-switch. The exact product, conditions, liver/kidney function, prior reactions and target-market label still need review together." } }, { "question": { "zh": "选择阿托伐他汀前，每个人都需要做全基因筛查吗？", "en": "Does everyone need whole-genome screening before atorvastatin is considered?" }, "answer": { "zh": "不是。当前 LIPITOR 标签首先要求核对准确产品、风险因素、症状和相互作用；它没有把全基因筛查写成所有人的普遍前置条件。若已经有药物基因报告，或专业团队认为某个特定检测会改变判断，应由其解释检测范围、证据限制和结果；不要自行购买宽泛检测后按报告停药、换药或改量。", "en": "No. The current LIPITOR label first requires review of the exact product, risk factors, symptoms and interactions; it does not state whole-genome screening as a universal prerequisite. If a pharmacogenomic report already exists, or the clinical team believes a specific test could change a decision, that team should explain the test scope, evidence limits and result. Do not buy broad testing and then self-stop, switch or adjust a medicine from the report." } }, { "question": { "zh": "老人同时吃很多药，出现肌肉痛或无力时怎么办？", "en": "What should an older adult taking many medicines do about muscle pain or weakness?" }, "answer": { "zh": "应及时联系当地医疗专业人员，并携带所有处方药、非处方药、保健品、草本、近期新增或停用药物以及实际药盒。当前标签把 65 岁及以上、肾功能受损、未控制的甲状腺功能减退、某些联用药和较高规格列为肌病风险核对线索。网页不能判断原因，也不要自行骤停、隔天轮换、补服或换成另一种他汀；若伴明显不适、发热、深色尿、严重无力或意识变化，应及时使用当地紧急医疗渠道。", "en": "Contact a local healthcare professional promptly and bring every prescription, OTC product, supplement, herb, recent start/stop change and actual pack. The current label identifies age 65 or older, renal impairment, uncontrolled hypothyroidism, certain co-medications and higher dosage as myopathy risk-review cues. The site cannot diagnose the cause, and the medicine should not be abruptly self-stopped, alternated, made up or replaced by another statin. Marked malaise, fever, dark urine, severe weakness or altered awareness needs prompt local urgent care." } }, { "question": { "zh": "这份档案能证明“原研”或“可替代”吗？", "en": "Does this archive prove originator status or interchangeability?" }, "answer": { "zh": "不能。它仅提供公开文件的阅读入口；原研/仿制关系与任何替代判断必须按具体市场、剂型和现行监管记录核验。", "en": "No. It is a public-document reading entry point. Originator/generic relationships and any substitution question require a specific market, dosage form and current regulatory record." } }, { "question": { "zh": "为什么不直接列出价格？", "en": "Why is no price shown here?" }, "answer": { "zh": "公开价格必须同时锁定产品、规格、包装、市场、币种、日期和价格含义；这些字段未完整复核前不会发布比较结论。", "en": "A public price needs a verified product, strength, pack, market, currency, date and price meaning. No comparison is published before those fields are complete." } } ], "relatedMedicineChecks": [ { "target": { "id": "rosuvastatin-crestor", "brand": "CRESTOR", "generic": "瑞舒伐他汀钙", "canonicalUrls": { "zh": "https://origindrug.com/drugs/rosuvastatin-crestor/", "en": "https://origindrug.com/en/drugs/rosuvastatin-crestor/" } }, "title": { "zh": "与 CRESTOR／瑞舒伐他汀同在药单上时：不要把同类药当作可互换的两颗药", "en": "When CRESTOR / rosuvastatin is on the same list: do not treat same-class medicines as interchangeable tablets" }, "summary": { "zh": "LIPITOR 与 CRESTOR 的公开标签都说明其属于他汀类；这只是药物类别线索，不支持同日各服一颗、隔天轮换、按毫克换算、直接替换或自行加减。请把两种实际药盒、全部处方药、非处方药和补充剂交给药师或开方团队核对；本卡片不判断谁更适合哪一种药，也不建议自行停用、错开时间、替换或调整任何一种药。", "en": "Public LIPITOR and CRESTOR labels identify both medicines as statins. That is a class clue only; it does not support taking one of each on the same day, alternating days, milligram conversion, direct replacement or self-adjustment. Have a pharmacist or prescriber review both actual packs, every prescription medicine, OTC product and supplement; this card does not decide which medicine suits someone or advise self-stopping, time-separation, replacement or adjustment of either medicine." }, "source": { "id": "src_d6030b2d9ce833f1", "label": "DailyMed（NLM）：LIPITOR 阿托伐他汀当前美国公开标签", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a60cc18b-0631-4cf0-b021-9f52224ece65", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "review_complete_medicine_list_no_self_directed_change" } ], "relatedArticleSlugs": [ "originator-vs-generic", "dosage-forms-are-part-of-medicine-identity" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/atorvastatin-lipitor/", "en": "https://origindrug.com/en/drugs/atorvastatin-lipitor/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "amlodipine-norvasc", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-21", "status": "published_traceable_archive" }, "names": { "brand": "Norvasc", "generic": "氨氯地平", "aliases": [ "络活喜", "amlodipine", "amlodipine besylate" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": { "value": "络活喜®", "status": "discovery_cue_requires_target_market_verification", "source": { "id": "src_104aa9169b36e4d2", "label": "Pfizer China：立普妥／络活喜品牌名历史公开资料（2019）", "url": "https://www.pfizer.com.cn/zh-hans/news/press-release/619", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "first_party_release", "market": "CN", "accessStatus": "public_access_with_site_controls", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } } }, "identity": { "therapeuticArea": "心血管", "sourceArchiveMarket": "美国 DailyMed NORVASC 公开标签（SPL v29，2025-06-09 发布；标签正文 2017-03 修订）", "dosageFormClass": "口服片：2.5 mg、5 mg、10 mg（DailyMed NORVASC SPL v29 所列；分别展示三个 90 片瓶装面板）", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "1992", "archiveSponsorText": "Pfizer" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-norvasc-tablet-2-5mg-0069-1520-68", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v29（2025-06-09 发布；标签正文修订日期为 2017-03）", "en": "DailyMed SPL v29 (published 9 Jun 2025; label text revised Mar 2017)" }, "dosageForm": { "zh": "氨氯地平口服片", "en": "amlodipine oral tablet" }, "route": { "zh": "口服（仅作标签产品身份字段）", "en": "oral (label product-identity field only)" }, "routeCodes": [ "oral" ], "productCode": "NDC 0069-1520-68", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片 2.5 mg；90 片瓶装", "en": "2.5 mg per tablet; 90-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=norvasc-05.jpg&setid=abd6a2ca-40c2-485c-bc53-db1c652505ed&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "氨氯地平", "en": "amlodipine" }, "value": 2.5, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人服用片数或换算指令", "en": "labelled amount per tablet; not an individual tablet count or conversion instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "原瓶", "en": "bottle" }, "fill": null, "countPerPackage": 90, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-21", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 90, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "白色", "en": "white" }, "shape": { "zh": "菱形", "en": "diamond" }, "imprint": "NORVASC / 2.5", "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_cdfc862f755c6603", "label": "DailyMed（NLM）：NORVASC 氨氯地平公开标签（Pfizer；SPL v29）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=abd6a2ca-40c2-485c-bc53-db1c652505ed", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-norvasc-tablet-5mg-0069-1530-68", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v29（2025-06-09 发布；标签正文修订日期为 2017-03）", "en": "DailyMed SPL v29 (published 9 Jun 2025; label text revised Mar 2017)" }, "dosageForm": { "zh": "氨氯地平口服片", "en": "amlodipine oral tablet" }, "route": { "zh": "口服（仅作标签产品身份字段）", "en": "oral (label product-identity field only)" }, "routeCodes": [ "oral" ], "productCode": "NDC 0069-1530-68", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片 5 mg；90 片瓶装", "en": "5 mg per tablet; 90-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=norvasc-06.jpg&setid=abd6a2ca-40c2-485c-bc53-db1c652505ed&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "氨氯地平", "en": "amlodipine" }, "value": 5, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人服用片数或换算指令", "en": "labelled amount per tablet; not an individual tablet count or conversion instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "原瓶", "en": "bottle" }, "fill": null, "countPerPackage": 90, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-21", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 90, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "白色", "en": "white" }, "shape": { "zh": "八边形（延长八边形）", "en": "elongated octagon" }, "imprint": "NORVASC / 5", "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_cdfc862f755c6603", "label": "DailyMed（NLM）：NORVASC 氨氯地平公开标签（Pfizer；SPL v29）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=abd6a2ca-40c2-485c-bc53-db1c652505ed", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-norvasc-tablet-10mg-0069-1540-68", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v29（2025-06-09 发布；标签正文修订日期为 2017-03）", "en": "DailyMed SPL v29 (published 9 Jun 2025; label text revised Mar 2017)" }, "dosageForm": { "zh": "氨氯地平口服片", "en": "amlodipine oral tablet" }, "route": { "zh": "口服（仅作标签产品身份字段）", "en": "oral (label product-identity field only)" }, "routeCodes": [ "oral" ], "productCode": "NDC 0069-1540-68", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片 10 mg；90 片瓶装", "en": "10 mg per tablet; 90-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=norvasc-09.jpg&setid=abd6a2ca-40c2-485c-bc53-db1c652505ed&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "氨氯地平", "en": "amlodipine" }, "value": 10, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人服用片数或换算指令", "en": "labelled amount per tablet; not an individual tablet count or conversion instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "原瓶", "en": "bottle" }, "fill": null, "countPerPackage": 90, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-21", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 90, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "白色", "en": "white" }, "shape": { "zh": "圆形", "en": "round" }, "imprint": "NORVASC / 10", "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_cdfc862f755c6603", "label": "DailyMed（NLM）：NORVASC 氨氯地平公开标签（Pfizer；SPL v29）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=abd6a2ca-40c2-485c-bc53-db1c652505ed", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-norvasc-tablet-5mg-0069-1530-68", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=norvasc-06.jpg&setid=abd6a2ca-40c2-485c-bc53-db1c652505ed&type=img", "alt": "NORVASC 氨氯地平 5 mg 在美国 DailyMed SPL v29 公开标签中的 90 片瓶装主展示面", "archiveMarket": "美国", "labelVersion": "DailyMed SPL v29（2025-06-09 发布；标签正文修订日期为 2017-03）", "presentation": "NORVASC（氨氯地平）5 mg、90 片瓶装主展示面（NDC 0069-1530-68；DailyMed SPL v29 所列）。", "notice": "此图只对应美国 DailyMed SPL v29 中 NORVASC 5 mg、NDC 0069-1530-68、90 片瓶装主展示面，只帮助核对品牌、通用名、标示强度、片剂、包装数量与来源；不用于鉴定真伪，也不证明 2.5 mg、10 mg、泡罩、其他包装、其他市场标签、原研身份、目标市场批准或可售资格。", "source": { "id": "src_cdfc862f755c6603", "label": "DailyMed（NLM）：NORVASC 氨氯地平公开标签（Pfizer；SPL v29）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=abd6a2ca-40c2-485c-bc53-db1c652505ed", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "Norvasc 说明书放大阅读：2.5、5、10 mg 先是产品识别", "en": "Norvasc label reading: 2.5, 5 and 10 mg identify products first" }, "summary": { "zh": "美国 DailyMed NORVASC SPL v29 列有 2.5、5、10 mg 片剂和各自产品身份。本模块帮助读者区分“每片标示强度”和个人处方，不把包装数字转成个人剂量指令。", "en": "The U.S. DailyMed NORVASC SPL v29 lists 2.5, 5 and 10 mg tablets and their respective product identities. This module separates a stated strength per tablet from an individual's prescription; it does not turn package numbers into dosing instructions." }, "checks": [ { "zh": "“2.5、5、10 mg”是该美国标签中区分片剂规格的文字；它们不是几片之间可以任意相加、对半或换算的授权。看到不同规格时，先核对处方标签、目标市场和完整药名。", "en": "“2.5, 5 and 10 mg” distinguish tablet strengths in this U.S. label; they are not permission to add, halve or convert tablets freely. When strengths differ, first check the prescription label, target market and complete medicine name." }, { "zh": "同一标签描述了不同强度片剂的外形和刻字。这些是核对线索，不是用照片或外观鉴定真伪的依据，也不表示其他市场、其他版本或其他厂家片剂外观相同。", "en": "The label describes tablet shapes and debossing for different strengths. These are checking clues, not a way to authenticate a product, and do not establish that another market, version or maker has the same appearance." }, { "zh": "若同时服用多种降压、心脏、止痛、感冒或补充剂产品，带着每种产品的全名、强度、实际服用时间与不适记录请药师或医生核对；不要因药盒都写“降压”或“心脏”就自行合并或替换。", "en": "If several blood-pressure, heart, pain, cold or supplement products are being used, bring each product's full name, strength, actual timing and symptom record to a pharmacist or clinician. Do not self-combine or replace products merely because packages mention blood pressure or the heart." }, { "zh": "本页的美国公开标签不替代目标市场的当前说明书。尤其是高龄、多病共存或多药并用时，任何开始、停用、加减、掰开或换规格的问题都应先确认。", "en": "This U.S. public label does not replace the current label in the target market. Particularly with older age, multiple conditions or multiple medicines, confirm before starting, stopping, changing, splitting or changing strength." } ], "source": { "id": "src_cdfc862f755c6603", "label": "DailyMed（NLM）：NORVASC 氨氯地平公开标签（Pfizer；SPL v29）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=abd6a2ca-40c2-485c-bc53-db1c652505ed", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "氨氯地平怎样起作用：它影响血管平滑肌细胞的钙离子进入", "en": "How amlodipine works: it affects calcium-ion entry into vascular smooth-muscle cells" }, "summary": { "zh": "Pfizer 的 NORVASC 处方信息将氨氯地平描述为二氢吡啶类钙拮抗剂：它选择性抑制钙离子跨细胞膜进入血管平滑肌和心肌细胞，作用在血管平滑肌更明显。机制解释的是药物作用环节，不是对任何个人血压变化、适用性、片数或联用方案的承诺。", "en": "Pfizer's NORVASC prescribing information describes amlodipine as a dihydropyridine calcium antagonist that selectively inhibits transmembrane calcium-ion influx into vascular smooth and cardiac muscle, with a greater effect on vascular smooth muscle. This explains a drug-action step; it is not a promise of an individual's blood-pressure change, suitability, tablet count or combination plan." }, "checks": [ { "zh": "可以把“钙离子进入”理解为血管平滑肌收缩过程中的一个环节。标签还将氨氯地平描述为外周动脉血管扩张剂；这能帮助理解它为什么归入这类药，但不等于网页可以判断某个人该不该用、用哪种强度或是否需要加另一种降压药。", "en": "Calcium-ion entry can be read as one step in vascular smooth-muscle contraction. The label also describes amlodipine as a peripheral arterial vasodilator; that helps explain its class, but does not let a webpage decide whether a person should use it, at what strength, or with another blood-pressure medicine." }, { "zh": "“都用于血压或心脏问题”不表示产品可以自行叠加、轮换或替换。不同药物类别、剂型、既往反应、肾肝功能、其他处方药与非处方药都可能改变专业人员的判断；应连同完整药单一起复核。", "en": "“Both used for blood pressure or heart conditions” does not make products self-combinable, interchangeable or suitable for alternation. Drug class, dosage form, prior reactions, kidney/liver function, prescription medicines and OTC products can all affect professional review, which should use the complete medicine list." }, { "zh": "2.5、5、10 mg 等包装文字描述的是准确片剂的标示强度；机制相同不把不同强度变成可以按经验相加、对半或换算的片数。出现头晕、晕厥、胸部不适或不确定怎样服用时，应依据当地紧急与专业渠道处理，而不是从本页自行调整。", "en": "Package wording such as 2.5, 5 or 10 mg identifies the stated strength of an exact tablet. A shared mechanism does not make strengths freely addable, divisible or convertible by experience. With dizziness, fainting, chest discomfort or uncertainty about use, use local urgent and professional care pathways rather than self-adjusting from this page." } ], "source": { "id": "src_c5968453eaa2a2df", "label": "Pfizer：NORVASC 处方信息（Mechanism of Action）", "url": "https://labeling.pfizer.com/ShowLabeling.aspx?id=562", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "first_party_label", "market": "US", "accessStatus": "public_access_with_site_controls", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "Norvasc", "generic": "氨氯地平", "dosageFormClass": "口服片：2.5 mg、5 mg、10 mg（DailyMed NORVASC SPL v29 所列；分别展示三个 90 片瓶装面板）" }, "labelSource": { "id": "src_cdfc862f755c6603", "label": "DailyMed（NLM）：NORVASC 氨氯地平公开标签（Pfizer；SPL v29）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=abd6a2ca-40c2-485c-bc53-db1c652505ed", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "productRoutes": [ { "source": { "id": "src_cdfc862f755c6603", "label": "DailyMed（NLM）：NORVASC 氨氯地平公开标签（Pfizer；SPL v29）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=abd6a2ca-40c2-485c-bc53-db1c652505ed", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_dcb5b7226a5b98be", "label": "FDA：Norvasc 历史标签", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019787s038lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "美国 DailyMed 的 NORVASC（amlodipine besylate）SPL v29 公开标签列出 2.5 mg、5 mg、10 mg 口服片与对应瓶装面板。本页只帮助把品牌、通用名、片剂强度、包装和来源放在一起核对；不构成诊疗、剂量、处方、购买或目标市场当前可得性建议。", "history": "Norvasc 的标签修订记录体现了药品信息会随监管要求持续更新。阅读时应优先查看所在国家或地区的现行标签。", "sourceDocuments": [ { "id": "src_cdfc862f755c6603", "label": "DailyMed（NLM）：NORVASC 氨氯地平公开标签（Pfizer；SPL v29）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=abd6a2ca-40c2-485c-bc53-db1c652505ed", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_dcb5b7226a5b98be", "label": "FDA：Norvasc 历史标签", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019787s038lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_c5968453eaa2a2df", "label": "Pfizer 产品资料", "url": "https://labeling.pfizer.com/ShowLabeling.aspx?id=562", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "first_party_label", "market": "US", "accessStatus": "public_access_with_site_controls", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } ], "applicationNumber": "NDA 019787", "approvalTimeline": [ { "date": "1992", "title": { "zh": "FDA 标签所列美国初始批准年份", "en": "Initial U.S. approval year listed in the FDA label" }, "detail": { "zh": "本页链接的 FDA 标签档案列示 Initial U.S. Approval: 1992。该历史定位不等同于当前批准、可得性、持有人或其他市场状态。", "en": "The FDA label archive linked here lists Initial U.S. Approval: 1992. This historical locator is not a conclusion about current approval, availability, holder or another market." }, "source": { "id": "src_dcb5b7226a5b98be", "label": "FDA: NORVASC label archive", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019787s038lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, { "date": "2005", "title": { "zh": "FDA 标签档案版本", "en": "FDA label archive version" }, "detail": { "zh": "本页链接 2005 的 FDA 标签档案作为可复核阅读入口。现行标签、规格、适应症和安全信息必须另行以目标市场当前文件核对。", "en": "This page links the 2005 FDA label archive as a traceable reading entry point. Current labeling, strength, indication and safety information require separate verification against the target market’s current document." }, "source": { "id": "src_dcb5b7226a5b98be", "label": "FDA: NORVASC label archive", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019787s038lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "已链接公开标签档案", "en": "Public label archive linked" }, "detail": { "zh": "仅对应本页所列 FDA 文件。", "en": "Only the FDA document listed on this page is linked." } }, { "market": { "zh": "中国大陆、欧盟、日本", "en": "Mainland China, EU, Japan" }, "status": { "zh": "待逐项建立市场记录", "en": "Market record not established" }, "detail": { "zh": "不从美国标签档案推定当地批准、持有人、规格、供应或可售资格。", "en": "No local approval, holder, strength, supply or sale-eligibility conclusion is inferred from the U.S. label archive." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "标签档案能代表现在的产品信息吗？", "en": "Does a label archive represent current product information?" }, "answer": { "zh": "不能自动代表。档案用于定位来源；需要以目标市场的现行官方标签逐项复核。", "en": "Not automatically. The archive locates a source; each point needs verification against the target market’s current official label." } }, { "question": { "zh": "为什么这里不展示价格或原研/仿制结论？", "en": "Why are price and originator/generic conclusions not shown?" }, "answer": { "zh": "这些结论需要产品、剂型、规格、包装、市场、日期和原始记录分别齐全并经人工审核；单一标签文件不足以支持。", "en": "Those conclusions require separately complete and human-reviewed product, dosage-form, strength, pack, market, date and primary-record fields; one label file is insufficient." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "how-to-read-a-drug-label", "regulatory-sources-first" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/amlodipine-norvasc/", "en": "https://origindrug.com/en/drugs/amlodipine-norvasc/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "bisoprolol", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-30", "status": "published_traceable_archive" }, "names": { "brand": "康忻® / CONCOR® / CARDICOR", "generic": "比索洛尔", "aliases": [ "Bisoprolol", "bisoprolol fumarate", "比索洛尔富马酸盐", "康忻", "Concor", "Cardicor", "比索洛尔", "富马酸比索洛尔", "68788-8671-1", "29300-126" ], "marketBrandNames": [ { "name": "康忻® / Concor®", "market": { "zh": "中国大陆及跨市场企业品牌页", "en": "Mainland China and cross-market company brand page" }, "evidenceStatus": "company_product_page_name_and_strength_cue", "note": { "zh": "默克中国企业页面将康忻®／Concor®列为比索洛尔产品家族。本条只用于核对药盒文字与通用名线索；不确认任何具体国家或地区的现行批准、持有人、准确规格/包装、供应、可售资格、真伪或与其他比索洛尔产品可替代。", "en": "Merck China's company page identifies 康忻®/Concor® as a bisoprolol product family. This entry is only for checking pack text and the generic-name cue; it does not establish current authorisation, holder, exact strength/package, supply, sale eligibility, authenticity or interchangeability with another bisoprolol product in any country or region." }, "source": { "id": "src_cf1b33adecdebf99", "label": "默克中国：康忻® / Concor® 比索洛尔产品家族页面", "url": "https://www.merckgroup.com.cn/cn-zh/expertise/general-medicine/general-medicine-treatments/concor-concorcor.html/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "first_party_product_page", "market": "CN", "accessStatus": "public_access_with_site_controls", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, { "name": "CONCOR / CONCOR COR", "market": { "zh": "欧洲多国有日期授权清单", "en": "Dated authorisation list across multiple European countries" }, "evidenceStatus": "historical_regulatory_record", "note": { "zh": "EMA 的 2020 年 PSUSA 国家授权清单列出多个由 Merck 实体持有的 Concor／Concor COR 规格。本条证明该清单时点的品牌与授权记录，不证明 2026 年任一国家的现行供应、准确包装、可售资格或可替代性。", "en": "The EMA's 2020 PSUSA national-authorisation list includes multiple Concor/Concor COR strengths held by Merck entities. This establishes brand and authorisation records at that dated list, not current 2026 supply, exact packaging, sale eligibility or interchangeability in any country." }, "source": { "id": "src_056081cbddfa3b1f", "label": "EMA：比索洛尔国家授权产品清单（PSUSA/00000419/201909）", "url": "https://www.ema.europa.eu/documents/psusa/bisoprolol-list-nationally-authorised-medicinal-products-psusa/00000419/202009_.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "regulatory_record", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, { "name": "CARDICOR", "market": { "zh": "英国公开药品信息", "en": "UK public medicine information" }, "evidenceStatus": "dated_public_product_label", "note": { "zh": "英国 eMC 当前可访问的 Merck Cardicor SmPC/PIL 合并列出六种薄膜衣片强度；内容最后更新 2020-11-17。它是英国产品资料入口，不替代中国大陆康忻或其他市场现行说明书。", "en": "The currently accessible UK emc Merck Cardicor SmPC/PIL jointly lists six film-coated tablet strengths; its content was last updated on 17 Nov 2020. It is a UK product-information route and does not replace the current label for Concor in Mainland China or another market." }, "source": { "id": "src_75cb1912393f6b2e", "label": "英国 eMC：Merck Cardicor 1.25–10 mg 薄膜衣片 SmPC", "url": "https://www.medicines.org.uk/emc/product/7765/smpc", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" } } ], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "心血管", "sourceArchiveMarket": "默克中国企业页面将康忻®／Concor®列为比索洛尔产品家族；EMA 2020 年 PSUSA 国家授权清单列有多个 Merck 的 Concor／Concor COR 产品；英国 eMC 当前可访问的 Merck Cardicor SmPC／PIL 合并列出 1.25、2.5、3.75、5、7.5、10 mg 薄膜衣片（文件内容最后更新 2020-11-17）。美国另列 DailyMed 2026-03-20 更新的再包装通用药标签。各来源只约束其市场、时间和准确文件，不互相证明现行供应、包装、可售资格或可替代性。", "dosageFormClass": "富马酸比索洛尔薄膜衣口服片：英国 Cardicor 1.25、2.5、3.75、5、7.5、10 mg；美国再包装标签 5、10 mg", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "欧盟 2020 年 PSUSA 授权清单与现行可访问品牌资料均为来源节点；初始批准年份不在本页推定", "archiveSponsorText": "Merck 品牌家族资料／EMA 国家授权清单／英国 eMC Merck Cardicor 说明书；另列美国再包装通用药标签作比较" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-bisoprolol-fumarate-tablets-5-and-10mg-repackaged-label-ndc-68788-8671-1", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（2026-03-20 更新；再包装标签）", "en": "Current U.S. DailyMed public label (updated 20 Mar 2026; repackaged label)" }, "dosageForm": { "zh": "富马酸比索洛尔口服片", "en": "bisoprolol fumarate oral tablet" }, "route": { "zh": "口服（标签产品身份字段）", "en": "oral (label product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 68788-8671-1 (source NDC 29300-126)", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "5 mg、10 mg 每片标示量（美国标签）", "en": "5 mg and 10 mg labelled per tablet (U.S. label)" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "富马酸比索洛尔", "en": "bisoprolol fumarate" }, "value": 5, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "5 mg 每片标签标示量；不是个人片数、频率或换算指令", "en": "5 mg labelled per tablet; not an individual's tablet count, frequency or conversion instruction" } }, { "ingredient": { "zh": "富马酸比索洛尔", "en": "bisoprolol fumarate" }, "value": 10, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "10 mg 每片标签标示量；不是个人片数、频率或换算指令", "en": "10 mg labelled per tablet; not an individual's tablet count, frequency or conversion instruction" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-23", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": null, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_b6ac90f632e1d88a", "label": "DailyMed（NLM）：BISOPROLOL FUMARATE 当前美国公开标签（Preferred Pharmaceuticals；2026-03-20 更新；再包装标签）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=c0e309f3-82c3-4629-b790-fb8538b87369&version=3", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "gb-cardicor-bisoprolol-fumarate-1-25mg-film-coated-tablet-emc-7765", "marketCode": "GB", "labelVersion": { "zh": "英国 eMC 当前可访问的 Merck Cardicor SmPC（内容最后更新 2020-11-17；不推定当前供应）", "en": "Merck Cardicor SmPC currently accessible on UK emc (content last updated 17 Nov 2020; current supply not inferred)" }, "dosageForm": { "zh": "Cardicor 富马酸比索洛尔薄膜衣口服片", "en": "Cardicor bisoprolol fumarate film-coated oral tablet" }, "route": { "zh": "口服（说明书产品身份字段）", "en": "oral (label product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "UK eMC product 7765 shared SmPC", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "Cardicor 每片 1.25 mg（英国说明书文字身份）", "en": "Cardicor 1.25 mg per tablet (UK label text identity)" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "富马酸比索洛尔", "en": "bisoprolol fumarate" }, "value": 1.25, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片说明书标示量；不是个人片数、频率或换算指令", "en": "labelled per tablet; not an individual's tablet count, frequency or conversion instruction" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-30", "currentLabelDisplayed": true, "ndcDirectoryListed": false, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": null, "physicalClues": { "color": { "zh": "白色", "en": "white" }, "shape": { "zh": "圆形、无刻痕薄膜衣片", "en": "round and unscored film-coated tablet" }, "imprint": null, "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_75cb1912393f6b2e", "label": "英国 eMC：Merck Cardicor 1.25–10 mg 薄膜衣片 SmPC（产品 7765；内容最后更新 2020-11-17）", "url": "https://www.medicines.org.uk/emc/product/7765/smpc", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "gb-cardicor-bisoprolol-fumarate-2-5mg-film-coated-tablet-emc-7765", "marketCode": "GB", "labelVersion": { "zh": "英国 eMC 当前可访问的 Merck Cardicor SmPC（内容最后更新 2020-11-17；不推定当前供应）", "en": "Merck Cardicor SmPC currently accessible on UK emc (content last updated 17 Nov 2020; current supply not inferred)" }, "dosageForm": { "zh": "Cardicor 富马酸比索洛尔薄膜衣口服片", "en": "Cardicor bisoprolol fumarate film-coated oral tablet" }, "route": { "zh": "口服（说明书产品身份字段）", "en": "oral (label product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "UK eMC product 7765 shared SmPC", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "Cardicor 每片 2.5 mg（英国说明书文字身份）", "en": "Cardicor 2.5 mg per tablet (UK label text identity)" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "富马酸比索洛尔", "en": "bisoprolol fumarate" }, "value": 2.5, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片说明书标示量；不是个人片数、频率或换算指令", "en": "labelled per tablet; not an individual's tablet count, frequency or conversion instruction" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-30", "currentLabelDisplayed": true, "ndcDirectoryListed": false, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": null, "physicalClues": { "color": { "zh": "白色", "en": "white" }, "shape": { "zh": "心形、有刻痕薄膜衣片", "en": "heart-shaped and scored film-coated tablet" }, "imprint": null, "scoreStatus": "scored_status_not_a_split_instruction", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_75cb1912393f6b2e", "label": "英国 eMC：Merck Cardicor 1.25–10 mg 薄膜衣片 SmPC（产品 7765；内容最后更新 2020-11-17）", "url": "https://www.medicines.org.uk/emc/product/7765/smpc", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "gb-cardicor-bisoprolol-fumarate-3-75mg-film-coated-tablet-emc-7765", "marketCode": "GB", "labelVersion": { "zh": "英国 eMC 当前可访问的 Merck Cardicor SmPC（内容最后更新 2020-11-17；不推定当前供应）", "en": "Merck Cardicor SmPC currently accessible on UK emc (content last updated 17 Nov 2020; current supply not inferred)" }, "dosageForm": { "zh": "Cardicor 富马酸比索洛尔薄膜衣口服片", "en": "Cardicor bisoprolol fumarate film-coated oral tablet" }, "route": { "zh": "口服（说明书产品身份字段）", "en": "oral (label product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "UK eMC product 7765 shared SmPC", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "Cardicor 每片 3.75 mg（英国说明书文字身份）", "en": "Cardicor 3.75 mg per tablet (UK label text identity)" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "富马酸比索洛尔", "en": "bisoprolol fumarate" }, "value": 3.75, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片说明书标示量；不是个人片数、频率或换算指令", "en": "labelled per tablet; not an individual's tablet count, frequency or conversion instruction" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-30", "currentLabelDisplayed": true, "ndcDirectoryListed": false, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": null, "physicalClues": { "color": { "zh": "灰白色", "en": "off-white" }, "shape": { "zh": "心形、有刻痕薄膜衣片", "en": "heart-shaped and scored film-coated tablet" }, "imprint": null, "scoreStatus": "scored_status_not_a_split_instruction", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_75cb1912393f6b2e", "label": "英国 eMC：Merck Cardicor 1.25–10 mg 薄膜衣片 SmPC（产品 7765；内容最后更新 2020-11-17）", "url": "https://www.medicines.org.uk/emc/product/7765/smpc", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "gb-cardicor-bisoprolol-fumarate-5mg-film-coated-tablet-emc-7765", "marketCode": "GB", "labelVersion": { "zh": "英国 eMC 当前可访问的 Merck Cardicor SmPC（内容最后更新 2020-11-17；不推定当前供应）", "en": "Merck Cardicor SmPC currently accessible on UK emc (content last updated 17 Nov 2020; current supply not inferred)" }, "dosageForm": { "zh": "Cardicor 富马酸比索洛尔薄膜衣口服片", "en": "Cardicor bisoprolol fumarate film-coated oral tablet" }, "route": { "zh": "口服（说明书产品身份字段）", "en": "oral (label product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "UK eMC product 7765 shared SmPC", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "Cardicor 每片 5 mg（英国说明书文字身份）", "en": "Cardicor 5 mg per tablet (UK label text identity)" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "富马酸比索洛尔", "en": "bisoprolol fumarate" }, "value": 5, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片说明书标示量；不是个人片数、频率或换算指令", "en": "labelled per tablet; not an individual's tablet count, frequency or conversion instruction" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-30", "currentLabelDisplayed": true, "ndcDirectoryListed": false, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": null, "physicalClues": { "color": { "zh": "黄白色", "en": "yellowish white" }, "shape": { "zh": "心形、有刻痕薄膜衣片", "en": "heart-shaped and scored film-coated tablet" }, "imprint": null, "scoreStatus": "scored_status_not_a_split_instruction", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_75cb1912393f6b2e", "label": "英国 eMC：Merck Cardicor 1.25–10 mg 薄膜衣片 SmPC（产品 7765；内容最后更新 2020-11-17）", "url": "https://www.medicines.org.uk/emc/product/7765/smpc", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "gb-cardicor-bisoprolol-fumarate-7-5mg-film-coated-tablet-emc-7765", "marketCode": "GB", "labelVersion": { "zh": "英国 eMC 当前可访问的 Merck Cardicor SmPC（内容最后更新 2020-11-17；不推定当前供应）", "en": "Merck Cardicor SmPC currently accessible on UK emc (content last updated 17 Nov 2020; current supply not inferred)" }, "dosageForm": { "zh": "Cardicor 富马酸比索洛尔薄膜衣口服片", "en": "Cardicor bisoprolol fumarate film-coated oral tablet" }, "route": { "zh": "口服（说明书产品身份字段）", "en": "oral (label product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "UK eMC product 7765 shared SmPC", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "Cardicor 每片 7.5 mg（英国说明书文字身份）", "en": "Cardicor 7.5 mg per tablet (UK label text identity)" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "富马酸比索洛尔", "en": "bisoprolol fumarate" }, "value": 7.5, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片说明书标示量；不是个人片数、频率或换算指令", "en": "labelled per tablet; not an individual's tablet count, frequency or conversion instruction" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-30", "currentLabelDisplayed": true, "ndcDirectoryListed": false, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": null, "physicalClues": { "color": { "zh": "浅黄色", "en": "pale yellow" }, "shape": { "zh": "心形、有刻痕薄膜衣片", "en": "heart-shaped and scored film-coated tablet" }, "imprint": null, "scoreStatus": "scored_status_not_a_split_instruction", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_75cb1912393f6b2e", "label": "英国 eMC：Merck Cardicor 1.25–10 mg 薄膜衣片 SmPC（产品 7765；内容最后更新 2020-11-17）", "url": "https://www.medicines.org.uk/emc/product/7765/smpc", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "gb-cardicor-bisoprolol-fumarate-10mg-film-coated-tablet-emc-7765", "marketCode": "GB", "labelVersion": { "zh": "英国 eMC 当前可访问的 Merck Cardicor SmPC（内容最后更新 2020-11-17；不推定当前供应）", "en": "Merck Cardicor SmPC currently accessible on UK emc (content last updated 17 Nov 2020; current supply not inferred)" }, "dosageForm": { "zh": "Cardicor 富马酸比索洛尔薄膜衣口服片", "en": "Cardicor bisoprolol fumarate film-coated oral tablet" }, "route": { "zh": "口服（说明书产品身份字段）", "en": "oral (label product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "UK eMC product 7765 shared SmPC", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "Cardicor 每片 10 mg（英国说明书文字身份）", "en": "Cardicor 10 mg per tablet (UK label text identity)" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "富马酸比索洛尔", "en": "bisoprolol fumarate" }, "value": 10, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片说明书标示量；不是个人片数、频率或换算指令", "en": "labelled per tablet; not an individual's tablet count, frequency or conversion instruction" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-30", "currentLabelDisplayed": true, "ndcDirectoryListed": false, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": null, "physicalClues": { "color": { "zh": "浅橙色至淡橙色", "en": "pale orange to light orange" }, "shape": { "zh": "心形、有刻痕薄膜衣片", "en": "heart-shaped and scored film-coated tablet" }, "imprint": null, "scoreStatus": "scored_status_not_a_split_instruction", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_75cb1912393f6b2e", "label": "英国 eMC：Merck Cardicor 1.25–10 mg 薄膜衣片 SmPC（产品 7765；内容最后更新 2020-11-17）", "url": "https://www.medicines.org.uk/emc/product/7765/smpc", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "status": "withheld_repackaged_or_non_exact_visual", "title": { "zh": "Cardicor 已核验文字外观、美国资料为再包装标签；均不冒充准确原品牌包装图", "en": "Cardicor text appearance is verified and the U.S. record is repackaged; neither is presented as an exact original-brand package image" }, "summary": { "zh": "英国 Cardicor SmPC 提供六种片剂的颜色、形状与刻痕文字，但未提供可与单一强度、单一包装逐一对应的公开精确药盒图；美国 DailyMed 页面则明确是再包装标签。为避免把说明书文字、再包装图或其他市场零售图误读为康忻／Concor／Cardicor 的准确原品牌药盒，本页以文字身份卡展示外观和强度，并保留原始说明书链接供放大阅读。", "en": "The UK Cardicor SmPC provides colour, shape and score wording for six tablets but no public exact pack image matched one to one to a single strength and package; the U.S. DailyMed page is explicitly repackaged. To avoid treating label text, a repackaged image or another-market retail image as an exact Concor/Cardicor original-brand pack, the page uses text identity cards for appearance and strength and retains primary label links for enlarged reading." }, "source": { "id": "src_75cb1912393f6b2e", "label": "英国 eMC：Merck Cardicor 1.25–10 mg 薄膜衣片 SmPC", "url": "https://www.medicines.org.uk/emc/product/7765/smpc", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "康忻 / Concor / Cardicor 说明书放大阅读：先分清品牌、市场、每片 mg 和刻痕", "en": "Concor / Cardicor label reading: first separate brand, market, mg per tablet and score status" }, "summary": { "zh": "本模块同时提供默克中国品牌家族、EMA 有日期授权清单、英国 eMC Merck Cardicor SmPC/PIL 和美国再包装通用药标签入口。它帮助核对品牌、富马酸比索洛尔、薄膜衣片、每片强度、外观和文件市场；不能给出任何人的片数、服用时间、漏用处理、分片、停用、换药或联用答案。", "en": "This module links the Merck China brand family, a dated EMA authorisation list, UK emc Merck Cardicor SmPC/PIL and a U.S. repackaged generic label. It helps check brand, bisoprolol fumarate, film-coated tablet, per-tablet strength, appearance and document market; it cannot provide anyone's tablet count, timing, missed-use handling, splitting, stopping, switching or combination plan." }, "checks": [ { "zh": "先把康忻／Concor／Cardicor 或实际商品名、富马酸比索洛尔、薄膜衣口服片、每片 mg、实际包装和目标市场一起核对。共同写有“比索洛尔”或相同数字，不证明另一强度、另一品牌、另一种 β 受体阻断剂或另一市场产品可以自行替换、叠加或轮换。", "en": "Check Concor, Cardicor or the actual trade name, bisoprolol fumarate, film-coated oral tablet, mg per tablet, actual pack and target market together. A shared bisoprolol name or number does not prove that another strength, brand, beta-blocker or another-market product can be self-substituted, combined or alternated." }, { "zh": "英国 Cardicor SmPC 合并列出 1.25、2.5、3.75、5、7.5、10 mg；美国再包装标签列 5、10 mg。它们是各自文件中区分准确片剂的每片标示量，不是网页可转成“每天几颗”、把两种规格相加、改时点或漏用后补用的公式。", "en": "The UK Cardicor SmPC jointly lists 1.25, 2.5, 3.75, 5, 7.5 and 10 mg; the U.S. repackaged label lists 5 and 10 mg. These distinguish exact tablets in their own documents, not a webpage formula for how many per day, adding strengths, changing timing or making up missed use." }, { "zh": "标签将比索洛尔描述为 β1 选择性（心脏选择性）肾上腺素能受体阻断剂，并提醒这种选择性并非绝对。看到心率、血压、呼吸不适、晕厥、明显头晕，或准备手术/牙科操作时，应使用当地医疗与开方团队渠道；不要据此页面自行增减、骤停或改用另一种心血管药。", "en": "The label describes bisoprolol as a beta1-selective (cardioselective) adrenoceptor blocker and notes that this selectivity is not absolute. With heart-rate or blood-pressure concerns, breathing difficulty, fainting, marked dizziness, or a planned surgical/dental procedure, use local medical and prescribing-team channels; do not self-adjust, abruptly stop or change to another cardiovascular medicine from this page." }, { "zh": "英国 Cardicor SmPC 说明 2.5–10 mg 的所列刻痕片可以等分，但这是该准确 Cardicor 文件的产品特异文字，不自动适用于康忻、Concor、美国通用药或其他厂家的片剂，也不代表任何人应掰片。是否分片必须结合实际包装、现行本地说明书、处方和药师/开方团队核对。", "en": "The UK Cardicor SmPC says the listed scored 2.5–10 mg tablets can be divided into equal doses, but that is product-specific wording for the exact Cardicor document. It does not automatically apply to Concor, a U.S. generic or another maker's tablet, and does not mean anyone should split a tablet. Splitting requires the actual pack, current local label, prescription and pharmacist/prescriber review." }, { "zh": "若药单还有美托洛尔、卡维地洛、地高辛、可乐定、维拉帕米、地尔硫卓、胺碘酮、降糖药、滴眼液中的 β 受体阻断剂、非处方药或补充剂，应将每一种实际药盒和完整药单一起交给药师或开方团队核对。不要因都写“心脏”“血压”或“β 受体阻断剂”就自行合并、错开或替换。", "en": "If the list also includes metoprolol, carvedilol, digoxin, clonidine, verapamil, diltiazem, amiodarone, glucose-lowering medicines, a beta-blocker eye drop, OTC product or supplement, take every actual pack and the complete medicine list to a pharmacist or prescriber. Do not self-combine, time-separate or substitute products merely because they mention the heart, blood pressure or beta blockade." } ], "source": { "id": "src_75cb1912393f6b2e", "label": "英国 eMC：Merck Cardicor 1.25–10 mg 薄膜衣片 SmPC（产品 7765；说明书放大阅读入口）", "url": "https://www.medicines.org.uk/emc/product/7765/smpc", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "比索洛尔怎样起作用：β1 选择性解释的是路径，不是个人方案", "en": "How bisoprolol works: beta1 selectivity explains a pathway, not an individual plan" }, "summary": { "zh": "该美国公开标签将富马酸比索洛尔描述为合成的 β1 选择性（心脏选择性）肾上腺素能受体阻断剂；高剂量时其选择性并非绝对。这个机制帮助读者理解类别与为何需审核完整药单，不能预测个人心率、血压、呼吸情况、适用性或任何联合用药方案。", "en": "The U.S. public label describes bisoprolol fumarate as a synthetic beta1-selective (cardioselective) adrenoceptor blocker; at higher doses its selectivity is not absolute. This mechanism helps explain the class and why a complete medicine list needs review; it cannot predict individual heart rate, blood pressure, breathing, suitability or any combination plan." }, "checks": [ { "zh": "“β1 选择性”描述的是受体作用的相对倾向，不是凭网页判断某个人一定适合、一定耐受，或能否与另一种心率/血压相关药一起使用的结论。既往反应、呼吸病史、检查结果、完整药单和准确产品标签都需要专业人员一起核对。", "en": "‘Beta1 selectivity’ describes a relative receptor tendency; it is not a webpage conclusion that a person is definitely suitable, will definitely tolerate it, or can use it with another heart-rate/blood-pressure-related medicine. Prior reactions, respiratory history, tests, the complete medicine list and the exact product label all need professional review." }, { "zh": "药物类别或机制相近，不建立比索洛尔与美托洛尔、卡维地洛或其他 β 受体阻断剂之间的个人换算、同日叠加、隔天轮换或互换关系。名称、盐型、强度、剂型、市场标签和处方都是产品身份的一部分。", "en": "A similar class or mechanism does not establish personal conversion, same-day combination, alternate-day use or interchangeability between bisoprolol, metoprolol, carvedilol or another beta-blocker. Name, salt, strength, dosage form, market label and prescription are all part of product identity." }, { "zh": "老年人或多药并用时，机制解释尤其不能代替逐项核对：请带上所有药盒、处方标签、非处方药和补充剂，并记下实际服用时间和不适，交由药师或开方团队阅读。", "en": "For older people or people using multiple medicines, a mechanism explanation especially cannot replace item-by-item review: bring all packs, prescription labels, OTC products and supplements, and note actual timing and symptoms for a pharmacist or prescribing team to review." } ], "source": { "id": "src_b6ac90f632e1d88a", "label": "DailyMed（NLM）：BISOPROLOL FUMARATE 当前美国公开标签（Preferred Pharmaceuticals；Clinical Pharmacology；2026-03-20 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=c0e309f3-82c3-4629-b790-fb8538b87369&version=3", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "康忻® / CONCOR® / CARDICOR", "generic": "比索洛尔", "dosageFormClass": "富马酸比索洛尔薄膜衣口服片：英国 Cardicor 1.25、2.5、3.75、5、7.5、10 mg；美国再包装标签 5、10 mg" }, "labelSource": { "id": "src_75cb1912393f6b2e", "label": "英国 eMC：Merck Cardicor 1.25–10 mg 薄膜衣片 SmPC（产品 7765；内容最后更新 2020-11-17）", "url": "https://www.medicines.org.uk/emc/product/7765/smpc", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "productRoutes": [ { "source": { "id": "src_75cb1912393f6b2e", "label": "英国 eMC：Merck Cardicor 1.25–10 mg 薄膜衣片 SmPC（产品 7765；内容最后更新 2020-11-17）", "url": "https://www.medicines.org.uk/emc/product/7765/smpc", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "status": "product_level_public_record_verified", "authority": { "zh": "英国电子药品目录 eMC", "en": "UK electronic medicines compendium (emc)" }, "market": { "zh": "英国", "en": "United Kingdom" }, "recordType": { "zh": "公开药品说明书或患者说明书", "en": "Public product information or patient leaflet" }, "reviewedAt": "2026-08-30", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_9bf2e9f496055438", "label": "英国 eMC：Merck Cardicor 患者说明书 PIL（产品 7765）", "url": "https://www.medicines.org.uk/emc/product/7765/pil", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "status": "product_level_public_record_verified", "authority": { "zh": "英国电子药品目录 eMC", "en": "UK electronic medicines compendium (emc)" }, "market": { "zh": "英国", "en": "United Kingdom" }, "recordType": { "zh": "公开药品说明书或患者说明书", "en": "Public product information or patient leaflet" }, "reviewedAt": "2026-08-30", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_b6ac90f632e1d88a", "label": "DailyMed（NLM）：BISOPROLOL FUMARATE 当前美国公开标签（Preferred Pharmaceuticals；2026-03-20 更新；再包装标签）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=c0e309f3-82c3-4629-b790-fb8538b87369&version=3", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-23", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "英国电子药品目录 eMC", "en": "UK electronic medicines compendium (emc)" }, "market": { "zh": "英国", "en": "United Kingdom" }, "recordType": { "zh": "公开药品说明书或患者说明书", "en": "Public product information or patient leaflet" }, "reviewedAt": "2026-08-30", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "康忻®／Concor®／Cardicor 与比索洛尔属于同一默克品牌家族线索，但不同国家、商品名、适应范围、强度和包装必须分别核对。英国 Cardicor 资料列有六种每片强度，美国资料则是再包装通用药标签。本页把品牌、通用名、盐型、每片 mg、外观和文件市场并列，帮助老人和家属先认清手中药；不把任何 mg 或刻痕写成个人片数、开始/停用、掰片、换药或联用方案。", "history": "默克中国品牌页、EMA 2020 年国家授权清单和英国 eMC Merck Cardicor SmPC/PIL 共同提供跨市场品牌与文件线索；美国 DailyMed 标签明确是再包装通用药资料。它们不能混成一张‘全球统一药盒’，也不能从 Cardicor 的刻痕说明推到康忻、Concor、美国通用药或其他厂家的片剂。", "sourceDocuments": [ { "id": "src_cf1b33adecdebf99", "label": "默克中国：康忻® / Concor® 比索洛尔产品家族页面", "url": "https://www.merckgroup.com.cn/cn-zh/expertise/general-medicine/general-medicine-treatments/concor-concorcor.html/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "first_party_product_page", "market": "CN", "accessStatus": "public_access_with_site_controls", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_056081cbddfa3b1f", "label": "EMA：比索洛尔国家授权产品清单（PSUSA/00000419/201909；有日期历史监管清单）", "url": "https://www.ema.europa.eu/documents/psusa/bisoprolol-list-nationally-authorised-medicinal-products-psusa/00000419/202009_.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "regulatory_record", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_75cb1912393f6b2e", "label": "英国 eMC：Merck Cardicor 1.25–10 mg 薄膜衣片 SmPC（产品 7765；内容最后更新 2020-11-17）", "url": "https://www.medicines.org.uk/emc/product/7765/smpc", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, { "id": "src_9bf2e9f496055438", "label": "英国 eMC：Merck Cardicor 患者说明书 PIL（产品 7765）", "url": "https://www.medicines.org.uk/emc/product/7765/pil", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, { "id": "src_b6ac90f632e1d88a", "label": "DailyMed（NLM）：BISOPROLOL FUMARATE 当前美国公开标签（Preferred Pharmaceuticals；2026-03-20 更新；再包装标签）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=c0e309f3-82c3-4629-b790-fb8538b87369&version=3", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" } ], "applicationNumber": "跨市场来源：EMA PSUSA/00000419/201909 国家授权清单；UK eMC product 7765 Cardicor；DailyMed SPL setid c0e309f3-82c3-4629-b790-fb8538b87369（美国再包装标签）", "approvalTimeline": [ { "date": "2020-09", "title": { "zh": "EMA 比索洛尔国家授权产品清单", "en": "EMA national-authorisation list for bisoprolol" }, "detail": { "zh": "EMA 的 PSUSA/00000419/201909 清单列出多个由 Merck 实体持有的 Concor、Concor COR、Cardicor 等国家授权产品与强度。该清单只证明文件时点的授权记录，不证明 2026 年任何国家的现行供应、准确包装、可售资格、真伪或可替代性。", "en": "The EMA PSUSA/00000419/201909 list records multiple nationally authorised Concor, Concor COR, Cardicor and related strengths held by Merck entities. It establishes records at the document date, not current 2026 supply, exact packaging, sale eligibility, authenticity or interchangeability in any country." }, "source": { "id": "src_056081cbddfa3b1f", "label": "EMA：比索洛尔国家授权产品清单（PSUSA/00000419/201909）", "url": "https://www.ema.europa.eu/documents/psusa/bisoprolol-list-nationally-authorised-medicinal-products-psusa/00000419/202009_.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "regulatory_record", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, { "date": "2020-11-17", "title": { "zh": "英国 Cardicor SmPC 内容更新节点", "en": "UK Cardicor SmPC content-update node" }, "detail": { "zh": "英国 eMC 的 Merck Cardicor SmPC 合并列出 1.25、2.5、3.75、5、7.5、10 mg 薄膜衣片、外观和刻痕说明。页面在 2026-08-30 仍可公开访问，但内容最后更新日期为 2020-11-17；因此本档案把它作为有日期的英国说明书来源，不把它写成实时库存或全球通用标签。", "en": "The UK emc Merck Cardicor SmPC jointly lists 1.25, 2.5, 3.75, 5, 7.5 and 10 mg film-coated tablets, appearance and score wording. The page remained publicly accessible on 30 Aug 2026, but its content was last updated on 17 Nov 2020; this dossier therefore treats it as dated UK product information, not live stock or a globally uniform label." }, "source": { "id": "src_75cb1912393f6b2e", "label": "英国 eMC：Merck Cardicor 1.25–10 mg 薄膜衣片 SmPC", "url": "https://www.medicines.org.uk/emc/product/7765/smpc", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" } }, { "date": "2026-03-20", "title": { "zh": "DailyMed 当前美国公开标签更新", "en": "Current U.S. DailyMed public label updated" }, "detail": { "zh": "DailyMed 将该 BISOPROLOL FUMARATE 口服片公开标签的 Updated 日期列为 2026-03-20，包装方为 Preferred Pharmaceuticals Inc.，并明确其为再包装标签。该节点仅定位 5 mg／10 mg 片剂、NDC 68788-8671-1 与来源 NDC 29300-126 的美国标签；不建立原品牌、实际在售、库存、购买、个人片数、分片、联用或换药结论。", "en": "DailyMed lists 20 Mar 2026 as the Updated date for this BISOPROLOL FUMARATE oral-tablet public label, identifies Preferred Pharmaceuticals Inc. as packager, and explicitly marks it repackaged. This node only locates the U.S. label for 5 mg/10 mg tablets, NDC 68788-8671-1 and source NDC 29300-126; it does not establish an original brand, actual availability, stock, purchase, individual tablet count, splitting, co-use or switching." }, "source": { "id": "src_b6ac90f632e1d88a", "label": "DailyMed（NLM）：BISOPROLOL FUMARATE 当前美国公开标签（Preferred Pharmaceuticals；2026-03-20 更新；再包装标签）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=c0e309f3-82c3-4629-b790-fb8538b87369&version=3", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "已链接当前公开再包装标签；未展示为原品牌包装", "en": "Current repackaged public label linked; not displayed as an original-brand package" }, "detail": { "zh": "本页只链接该美国标签的比索洛尔富马酸盐 5 mg／10 mg 口服片、NDC 68788-8671-1 和来源 NDC 29300-126。标签虽含包装图片，但已明确为再包装资料，因而不用于本页原品牌外观；也不建立实际在售、库存、购买、真伪、个人片数、频率、停用、换药或可替代性。", "en": "This page links only the U.S. label's bisoprolol fumarate 5 mg/10 mg oral tablets, NDC 68788-8671-1 and source NDC 29300-126. Although the label contains a package image, it is explicitly repackaged and is not used here as original-brand appearance; it also does not establish actual availability, stock, purchase, authenticity, individual tablet count, frequency, stopping, switching or interchangeability." } }, { "market": { "zh": "中国大陆品牌线索", "en": "Mainland China brand cue" }, "status": { "zh": "已链接默克中国康忻®／Concor®产品家族页；现行批准与包装仍需监管记录", "en": "Merck China Concor brand-family page linked; current authorisation and packaging still require regulatory records" }, "detail": { "zh": "默克中国企业页确认康忻®／Concor®与比索洛尔产品家族的关系，但不把企业品牌介绍替代为现行批准说明书、准确包装、供应或可售资格结论。", "en": "The Merck China company page confirms the relationship between Concor and the bisoprolol product family, but a company brand page does not replace a current approved label or establish exact packaging, supply or sale eligibility." } }, { "market": { "zh": "英国及欧洲有日期资料", "en": "Dated UK and European material" }, "status": { "zh": "已链接 Cardicor SmPC/PIL 与 EMA 国家授权清单", "en": "Cardicor SmPC/PIL and EMA national-authorisation list linked" }, "detail": { "zh": "页面建立 Cardicor 六种薄膜衣片的文字身份卡，并链接 EMA 的有日期国家授权清单。二者只在各自文件范围内提供品牌、强度、外观与授权线索，不证明 2026 年实时供应或跨市场替代。", "en": "The page builds text identity cards for six Cardicor film-coated tablets and links the dated EMA national-authorisation list. Each source provides brand, strength, appearance or authorisation cues only within its own document scope; neither proves real-time 2026 supply or cross-market substitution." } }, { "market": { "zh": "日本及其他市场", "en": "Japan and other markets" }, "status": { "zh": "待逐项建立现行市场记录", "en": "Current market record not established" }, "detail": { "zh": "不从中国、英国、EMA 或美国资料推定当地商品名、批准、包装、供应、可售资格、原研/仿制关系或可替代性；每个市场均须按当地现行监管资料单独核对。", "en": "No local trade name, approval, packaging, supply, sale eligibility, originator/generic relationship or interchangeability is inferred from Chinese, UK, EMA or U.S. material; every market requires separate checking against current local regulatory information." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "标签有 5 mg、10 mg，我能不能靠掰开、两种规格相加或换另一种 β 受体阻断剂来自己调整？", "en": "The label has 5 mg and 10 mg. Can I adjust myself by splitting, adding strengths or switching to another beta-blocker?" }, "answer": { "zh": "不能。5 mg、10 mg 是这个美国标签中准确片剂的身份字段；它们不建立个人片数、是否可掰、补用、加减、同日叠加、隔天轮换或与另一种 β 受体阻断剂换算的规则。请带着实际药盒、现行处方和完整药单交给药师或开方团队核对。", "en": "No. 5 mg and 10 mg are identity fields for exact tablets in this U.S. label; they do not establish individual tablet count, splitting, make-up use, adjustment, same-day combination, alternate-day use or conversion with another beta-blocker. Take the actual pack, current prescription and complete medicine list to a pharmacist or prescribing team for review." } }, { "question": { "zh": "英国 Cardicor 说明书说刻痕片可以等分，我手里的康忻或比索洛尔也能照做吗？", "en": "The UK Cardicor label says scored tablets can be divided equally. Can I apply that to my Concor or bisoprolol tablet?" }, "answer": { "zh": "不能跨产品照搬。该文字只约束英国 Cardicor 文件列出的准确片剂；康忻、Concor、美国通用药或其他厂家的处方、刻痕功能、辅料、片型和本地说明书可能不同。是否分片必须由实际药盒、现行本地说明书、处方和药师/开方团队共同确认。", "en": "Do not carry that wording across products. It applies only to the exact tablets listed in the UK Cardicor document; the prescription, functional score, excipients, tablet design and local label may differ for Concor, a U.S. generic or another maker. Splitting requires confirmation using the actual pack, current local label, prescription and pharmacist/prescriber review." } }, { "question": { "zh": "为什么页面不展示这份美国标签里的包装照片？", "en": "Why does the page not display the package photo in this U.S. label?" }, "answer": { "zh": "该 DailyMed 页面明确标为再包装标签。为了不把再包装图误读成原研、原品牌或其他市场的准确外观，本页保留可阅读的原始标签链接，却不把该图展示为原品牌包装。", "en": "This DailyMed page is explicitly identified as a repackaged label. To avoid reading a repackaged image as an originator, original-brand or another-market exact appearance, this page retains the readable primary-label link but does not display that image as an original-brand package." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "dosage-forms-are-part-of-medicine-identity", "how-to-read-a-drug-label" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/bisoprolol/", "en": "https://origindrug.com/en/drugs/bisoprolol/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "cardizem-la", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-23", "status": "published_traceable_archive" }, "names": { "brand": "CARDIZEM LA", "generic": "盐酸地尔硫卓", "aliases": [ "Cardizem LA", "地尔硫卓", "盐酸地尔硫卓", "地尔硫卓缓释片", "diltiazem", "diltiazem hydrochloride", "CARDIZEM LA", "0187-2045-90", "0187-2046-90", "0187-2047-90", "0187-2048-90", "0187-2049-90", "0187-2050-90" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "心血管", "sourceArchiveMarket": "美国：DailyMed 当前公开处方药标签（Bausch Health US LLC；2025-11-11 更新；NDA 021392）。本页不从该资料推定中国大陆、欧盟、日本或其他市场的商品名、批准、供应或可替代性。", "dosageFormClass": "盐酸地尔硫卓缓释口服片：120 mg、180 mg、240 mg、300 mg、360 mg、420 mg 每片（该美国公开标签所列）", "dosageFormClassCode": "oral_modified_release", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "1982（DailyMed 当前美国公开标签所列 Initial U.S. Approval）", "archiveSponsorText": "Bausch Health US LLC（DailyMed 当前美国公开标签所列包装方）" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-cardizem-la-diltiazem-hydrochloride-er-tablet-120mg-90-bottle-ndc-0187-2045-90", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（2025-11-11 更新）", "en": "Current U.S. DailyMed public label (updated 11 Nov 2025)" }, "dosageForm": { "zh": "盐酸地尔硫卓缓释口服片", "en": "diltiazem hydrochloride extended-release oral tablet" }, "route": { "zh": "口服（标签产品身份字段）", "en": "oral (label product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 0187-2045-90", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "120 mg 每片标示量；90 片瓶装（美国标签）", "en": "120 mg labelled per tablet; 90-tablet bottle (U.S. label)" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=label-120mg.jpg&setid=3e180dc7-c871-4efc-8755-cae882976c8d", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "盐酸地尔硫卓", "en": "diltiazem hydrochloride" }, "value": 120, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "120 mg 每片标签标示量；不是个人片数、频率或换算指令", "en": "120 mg labelled per tablet; not an individual's tablet count, frequency or conversion instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 90, "countUnit": { "zh": "片", "en": "tablets" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-23", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": null, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_30244518e22943f4", "label": "DailyMed（NLM）：CARDIZEM LA 盐酸地尔硫卓缓释片当前美国公开标签（Bausch Health US；2025-11-11 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=3e180dc7-c871-4efc-8755-cae882976c8d", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-cardizem-la-diltiazem-hydrochloride-er-tablet-180mg-90-bottle-ndc-0187-2046-90", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（2025-11-11 更新）", "en": "Current U.S. DailyMed public label (updated 11 Nov 2025)" }, "dosageForm": { "zh": "盐酸地尔硫卓缓释口服片", "en": "diltiazem hydrochloride extended-release oral tablet" }, "route": { "zh": "口服（标签产品身份字段）", "en": "oral (label product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 0187-2046-90", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "180 mg 每片标示量；90 片瓶装（美国标签）", "en": "180 mg labelled per tablet; 90-tablet bottle (U.S. label)" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=label-180mg.jpg&setid=3e180dc7-c871-4efc-8755-cae882976c8d", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "盐酸地尔硫卓", "en": "diltiazem hydrochloride" }, "value": 180, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "180 mg 每片标签标示量；不是个人片数、频率或换算指令", "en": "180 mg labelled per tablet; not an individual's tablet count, frequency or conversion instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 90, "countUnit": { "zh": "片", "en": "tablets" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-23", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": null, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_30244518e22943f4", "label": "DailyMed（NLM）：CARDIZEM LA 盐酸地尔硫卓缓释片当前美国公开标签（Bausch Health US；2025-11-11 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=3e180dc7-c871-4efc-8755-cae882976c8d", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-cardizem-la-diltiazem-hydrochloride-er-tablet-240mg-90-bottle-ndc-0187-2047-90", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（2025-11-11 更新）", "en": "Current U.S. DailyMed public label (updated 11 Nov 2025)" }, "dosageForm": { "zh": "盐酸地尔硫卓缓释口服片", "en": "diltiazem hydrochloride extended-release oral tablet" }, "route": { "zh": "口服（标签产品身份字段）", "en": "oral (label product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 0187-2047-90", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "240 mg 每片标示量；90 片瓶装（美国标签）", "en": "240 mg labelled per tablet; 90-tablet bottle (U.S. label)" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=label-240mg.jpg&setid=3e180dc7-c871-4efc-8755-cae882976c8d", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "盐酸地尔硫卓", "en": "diltiazem hydrochloride" }, "value": 240, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "240 mg 每片标签标示量；不是个人片数、频率或换算指令", "en": "240 mg labelled per tablet; not an individual's tablet count, frequency or conversion instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 90, "countUnit": { "zh": "片", "en": "tablets" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-23", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": null, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_30244518e22943f4", "label": "DailyMed（NLM）：CARDIZEM LA 盐酸地尔硫卓缓释片当前美国公开标签（Bausch Health US；2025-11-11 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=3e180dc7-c871-4efc-8755-cae882976c8d", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-cardizem-la-diltiazem-hydrochloride-er-tablet-300mg-90-bottle-ndc-0187-2048-90", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（2025-11-11 更新）", "en": "Current U.S. DailyMed public label (updated 11 Nov 2025)" }, "dosageForm": { "zh": "盐酸地尔硫卓缓释口服片", "en": "diltiazem hydrochloride extended-release oral tablet" }, "route": { "zh": "口服（标签产品身份字段）", "en": "oral (label product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 0187-2048-90", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "300 mg 每片标示量；90 片瓶装（美国标签）", "en": "300 mg labelled per tablet; 90-tablet bottle (U.S. label)" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=label-300mg.jpg&setid=3e180dc7-c871-4efc-8755-cae882976c8d", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "盐酸地尔硫卓", "en": "diltiazem hydrochloride" }, "value": 300, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "300 mg 每片标签标示量；不是个人片数、频率或换算指令", "en": "300 mg labelled per tablet; not an individual's tablet count, frequency or conversion instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 90, "countUnit": { "zh": "片", "en": "tablets" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-23", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": null, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_30244518e22943f4", "label": "DailyMed（NLM）：CARDIZEM LA 盐酸地尔硫卓缓释片当前美国公开标签（Bausch Health US；2025-11-11 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=3e180dc7-c871-4efc-8755-cae882976c8d", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-cardizem-la-diltiazem-hydrochloride-er-tablet-360mg-90-bottle-ndc-0187-2049-90", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（2025-11-11 更新）", "en": "Current U.S. DailyMed public label (updated 11 Nov 2025)" }, "dosageForm": { "zh": "盐酸地尔硫卓缓释口服片", "en": "diltiazem hydrochloride extended-release oral tablet" }, "route": { "zh": "口服（标签产品身份字段）", "en": "oral (label product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 0187-2049-90", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "360 mg 每片标示量；90 片瓶装（美国标签）", "en": "360 mg labelled per tablet; 90-tablet bottle (U.S. label)" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=label-360mg.jpg&setid=3e180dc7-c871-4efc-8755-cae882976c8d", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "盐酸地尔硫卓", "en": "diltiazem hydrochloride" }, "value": 360, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "360 mg 每片标签标示量；不是个人片数、频率或换算指令", "en": "360 mg labelled per tablet; not an individual's tablet count, frequency or conversion instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 90, "countUnit": { "zh": "片", "en": "tablets" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-23", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": null, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_30244518e22943f4", "label": "DailyMed（NLM）：CARDIZEM LA 盐酸地尔硫卓缓释片当前美国公开标签（Bausch Health US；2025-11-11 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=3e180dc7-c871-4efc-8755-cae882976c8d", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-cardizem-la-diltiazem-hydrochloride-er-tablet-420mg-90-bottle-ndc-0187-2050-90", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（2025-11-11 更新）", "en": "Current U.S. DailyMed public label (updated 11 Nov 2025)" }, "dosageForm": { "zh": "盐酸地尔硫卓缓释口服片", "en": "diltiazem hydrochloride extended-release oral tablet" }, "route": { "zh": "口服（标签产品身份字段）", "en": "oral (label product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 0187-2050-90", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "420 mg 每片标示量；90 片瓶装（美国标签）", "en": "420 mg labelled per tablet; 90-tablet bottle (U.S. label)" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=label-420mg.jpg&setid=3e180dc7-c871-4efc-8755-cae882976c8d", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "盐酸地尔硫卓", "en": "diltiazem hydrochloride" }, "value": 420, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "420 mg 每片标签标示量；不是个人片数、频率或换算指令", "en": "420 mg labelled per tablet; not an individual's tablet count, frequency or conversion instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 90, "countUnit": { "zh": "片", "en": "tablets" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-23", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": null, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_30244518e22943f4", "label": "DailyMed（NLM）：CARDIZEM LA 盐酸地尔硫卓缓释片当前美国公开标签（Bausch Health US；2025-11-11 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=3e180dc7-c871-4efc-8755-cae882976c8d", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-cardizem-la-diltiazem-hydrochloride-er-tablet-120mg-90-bottle-ndc-0187-2045-90", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=label-120mg.jpg&setid=3e180dc7-c871-4efc-8755-cae882976c8d", "alt": "CARDIZEM LA 盐酸地尔硫卓 120 mg 在美国 DailyMed 当前公开标签中的 90 片瓶装面板", "archiveMarket": "美国", "labelVersion": "DailyMed 当前美国公开标签（2025-11-11 更新）", "presentation": "CARDIZEM LA（盐酸地尔硫卓）缓释片 120 mg、90 片瓶装（NDC 0187-2045-90；DailyMed 当前标签所列）。", "notice": "此图只对应美国 DailyMed 当前标签中 CARDIZEM LA、盐酸地尔硫卓、缓释片、120 mg、NDC 0187-2045-90、90 片瓶装主展示面，只帮助核对品牌、通用名、标示强度、缓释片、包装数量与来源；不用于鉴定真伪，也不证明 180–420 mg、其他包装、其他市场标签、原研身份、目标市场批准或可售资格。", "source": { "id": "src_30244518e22943f4", "label": "DailyMed（NLM）：CARDIZEM LA 盐酸地尔硫卓缓释片当前美国公开标签（Bausch Health US；2025-11-11 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=3e180dc7-c871-4efc-8755-cae882976c8d", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "CARDIZEM LA 说明书放大阅读：缓释片的 mg 先用于认清这一盒药", "en": "CARDIZEM LA label reading: mg on an extended-release tablet identifies this exact product first" }, "summary": { "zh": "本模块以 DailyMed 当前美国公开标签为阅读入口，帮助核对 CARDIZEM LA、盐酸地尔硫卓、缓释口服片、每片标示量、特定 NDC 与瓶装。它不提供任何人的片数、服用时间、漏用处理、分片、停用、从其他地尔硫卓产品转换或联用答案。", "en": "This module uses the current U.S. DailyMed public label to check CARDIZEM LA, diltiazem hydrochloride, extended-release oral tablets, labelled per-tablet amount, a specific NDC and bottle. It does not provide anyone's tablet count, timing, missed-use handling, splitting, stopping, conversion from another diltiazem product or co-use answer." }, "checks": [ { "zh": "120、180、240、300、360、420 mg 是这份美国标签中区分缓释片的每片标示量；不是网页可转成“每天几颗”、几种规格相加、对半、补用或相互换算的公式。", "en": "120, 180, 240, 300, 360 and 420 mg distinguish extended-release tablets in this U.S. label; they are not a webpage formula for ‘how many each day’, adding strengths, halving, make-up use or conversion." }, { "zh": "该标签明确该缓释片应整片吞服，不应咀嚼或研碎。这个产品特异的文字不自动适用于其他地尔硫卓剂型、其他缓释片、胶囊或其他市场产品；任何吞咽困难、分片或换剂型问题都应由药师或开方团队按实际产品核对。", "en": "The label states that this extended-release tablet is swallowed whole and not chewed or crushed. That product-specific wording does not automatically apply to another diltiazem form, extended-release tablet, capsule or another-market product; swallowing difficulty, splitting or form-change questions need pharmacist or prescriber review for the actual product." }, { "zh": "标签中的“转为 CARDIZEM LA”文字是处方资料，不能被当成自助换算器。共同写有地尔硫卓、相近 mg 数、同为心脏或血压药，均不证明可以自行替换、叠加、轮换或调整。", "en": "The label's ‘switching to CARDIZEM LA’ wording is prescribing information, not a self-service conversion calculator. A shared diltiazem name, similar mg number, or heart/blood-pressure context does not prove products can be self-substituted, combined, alternated or adjusted." }, { "zh": "标签提示与可能影响心脏传导或收缩的药物、β 受体阻断剂、地高辛及多种代谢相关药物有关的核对线索。尤其是老人或多药并用时，请把全部实际药盒、处方标签、非处方药和补充剂一起交给药师或开方团队；不要自行停、加、错开或改用任何一种药。", "en": "The label flags review cues with medicines that may affect cardiac conduction or contractility, beta-blockers, digitalis and multiple metabolism-related products. Especially for older people or people using several medicines, take all actual packs, prescription labels, OTC products and supplements together to a pharmacist or prescriber; do not self-stop, add, time-separate or change any medicine." } ], "source": { "id": "src_30244518e22943f4", "label": "DailyMed（NLM）：CARDIZEM LA 盐酸地尔硫卓缓释片当前美国公开标签（Bausch Health US；2025-11-11 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=3e180dc7-c871-4efc-8755-cae882976c8d", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "地尔硫卓怎样起作用：钙通道阻滞解释机制，不替代个人方案", "en": "How diltiazem works: calcium-channel blockade explains a mechanism, not an individual plan" }, "summary": { "zh": "当前美国标签将 CARDIZEM LA 归为非二氢吡啶类钙通道阻滞剂。它帮助理解药物类别与为何心率、传导和完整药单需要一起核对，但不预测个人血压、心率、适用性、剂量或联合用药方案。", "en": "The current U.S. label classifies CARDIZEM LA as a nondihydropyridine calcium-channel blocker. This helps explain the class and why heart rate, conduction and the complete medicine list need review, but does not predict individual blood pressure, heart rate, suitability, dose or a combination plan." }, "checks": [ { "zh": "“钙通道阻滞剂”是药物类别与作用路径线索，不是“凡是降压或心脏药都能一起吃”的结论。药物类别、剂型、既往反应、心率与传导相关情况、肾肝功能和完整药单都需要专业人员逐项判断。", "en": "‘Calcium-channel blocker’ is a class and pathway clue, not a conclusion that every blood-pressure or heart medicine can be used together. Drug class, dosage form, prior reactions, heart-rate/conduction context, kidney/liver function and the complete medicine list need item-by-item professional review." }, { "zh": "与 β 受体阻断剂、地高辛或另一种心率相关药物有共同的“心脏”用途或机制线索，不建立同日叠加、轮换、替代或按 mg 换算的关系。", "en": "A shared heart-related use or mechanism cue with a beta-blocker, digoxin or another heart-rate-related medicine does not establish same-day combination, alternation, substitution or milligram conversion." }, { "zh": "机制阅读不能替代症状判断。若有昏厥、胸部不适、明显心悸、呼吸困难、严重头晕或其他急性问题，应使用当地紧急和医疗渠道，不应依据网页自行调整。", "en": "Mechanism reading cannot replace symptom assessment. With fainting, chest discomfort, pronounced palpitations, breathing difficulty, severe dizziness or another acute concern, use local urgent and medical care pathways rather than self-adjusting from a webpage." } ], "source": { "id": "src_30244518e22943f4", "label": "DailyMed（NLM）：CARDIZEM LA 盐酸地尔硫卓缓释片当前美国公开标签（Bausch Health US；Clinical Pharmacology；2025-11-11 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=3e180dc7-c871-4efc-8755-cae882976c8d", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "CARDIZEM LA", "generic": "盐酸地尔硫卓", "dosageFormClass": "盐酸地尔硫卓缓释口服片：120 mg、180 mg、240 mg、300 mg、360 mg、420 mg 每片（该美国公开标签所列）" }, "labelSource": { "id": "src_30244518e22943f4", "label": "DailyMed（NLM）：CARDIZEM LA 盐酸地尔硫卓缓释片当前美国公开标签（Bausch Health US；2025-11-11 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=3e180dc7-c871-4efc-8755-cae882976c8d", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "productRoutes": [ { "source": { "id": "src_30244518e22943f4", "label": "DailyMed（NLM）：CARDIZEM LA 盐酸地尔硫卓缓释片当前美国公开标签（Bausch Health US；2025-11-11 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=3e180dc7-c871-4efc-8755-cae882976c8d", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-23", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-23", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "美国 DailyMed 当前 CARDIZEM LA 标签列出盐酸地尔硫卓缓释口服片及 120 mg 至 420 mg 的每片标示量。本页把品牌、通用名、缓释片、每片标示量、特定 NDC、瓶装面板与原始标签放在一起，帮助先核对身份；不把 mg、90 片瓶装或说明书中的转换文字变成个人片数、分片、停用、换药或联用方案。", "history": "DailyMed 当前美国公开标签列示 Initial U.S. Approval: 1982、NDA 021392 与 2025-11 更新。这里的历史和标签节点仅用于定位这一美国品牌缓释片档案；它不证明任何市场的原研/仿制关系、库存、当前可得性、个人适用性或可自行换药。", "sourceDocuments": [ { "id": "src_30244518e22943f4", "label": "DailyMed（NLM）：CARDIZEM LA 盐酸地尔硫卓缓释片当前美国公开标签（Bausch Health US；2025-11-11 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=3e180dc7-c871-4efc-8755-cae882976c8d", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" } ], "applicationNumber": "NDA 021392（DailyMed 当前美国公开标签所列；本档案不据此推定其他市场状态）", "approvalTimeline": [ { "date": "1982", "title": { "zh": "美国公开标签所列初始批准年份", "en": "Initial U.S. approval year listed in the public label" }, "detail": { "zh": "DailyMed 的 CARDIZEM LA 当前美国公开标签列示 Initial U.S. Approval: 1982。该年份只定位这份美国标签的历史信息；不建立中国大陆或其他市场的批准、供应、可售资格、原研/仿制关系、可替代性或个人适用性。", "en": "The current U.S. DailyMed public label for CARDIZEM LA lists Initial U.S. Approval: 1982. This year only locates this U.S. label history; it does not establish approval, supply, sale eligibility, originator/generic relationship, interchangeability or individual suitability in Mainland China or another market." }, "source": { "id": "src_30244518e22943f4", "label": "DailyMed（NLM）：CARDIZEM LA 盐酸地尔硫卓缓释片当前美国公开标签（Bausch Health US；2025-11-11 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=3e180dc7-c871-4efc-8755-cae882976c8d", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" } }, { "date": "2025-11-11", "title": { "zh": "DailyMed 当前美国公开标签更新", "en": "Current U.S. DailyMed public label updated" }, "detail": { "zh": "本档案以 DailyMed 当前公开标签核对 CARDIZEM LA、盐酸地尔硫卓缓释片、120–420 mg 每片标示量、各 90 片瓶装 NDC 与 120 mg 瓶装面板。它不建立实际在售、库存、购买、个人片数、频率、分片、调量或换药方案。", "en": "This dossier uses the current DailyMed public label to check CARDIZEM LA, diltiazem hydrochloride extended-release tablets, labelled 120–420 mg per tablet, the NDCs for 90-tablet bottles and a 120 mg bottle panel. It does not establish actual marketing, stock, purchase, individual tablet count, frequency, splitting, adjustment or switching." }, "source": { "id": "src_30244518e22943f4", "label": "DailyMed（NLM）：CARDIZEM LA 盐酸地尔硫卓缓释片当前美国公开标签（Bausch Health US；2025-11-11 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=3e180dc7-c871-4efc-8755-cae882976c8d", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "已链接当前公开标签、六个 90 片瓶装身份与一个准确瓶装面板", "en": "Current public label, six 90-tablet bottle identities and one exact bottle panel linked" }, "detail": { "zh": "本页分别记录 CARDIZEM LA 缓释片 120、180、240、300、360、420 mg 的特定 90 片瓶装 NDC，并展示 120 mg、NDC 0187-2045-90 的标签面板。它不用于鉴定真伪，也不建立实际在售、库存、购买、个人片数、频率、停用、换药或可替代性。", "en": "This page records specific 90-tablet bottle NDCs for CARDIZEM LA extended-release tablets at 120, 180, 240, 300, 360 and 420 mg and displays the 120 mg, NDC 0187-2045-90 label panel. It does not authenticate a product or establish actual marketing, stock, purchase, individual tablet count, frequency, stopping, switching or interchangeability." } }, { "market": { "zh": "中国大陆、欧盟、日本及其他市场", "en": "Mainland China, EU, Japan and other markets" }, "status": { "zh": "待逐项建立现行市场记录", "en": "Current market record not established" }, "detail": { "zh": "不从美国标签、SPL、NDA、NDC、英文商品名、包装图或标签主体推定当地商品名、批准、包装、供应、可售资格、原研/仿制关系或可替代性；每个市场均须按当地现行监管资料单独核对。", "en": "No local trade name, approval, packaging, supply, sale eligibility, originator/generic relationship or interchangeability is inferred from the U.S. label, SPL, NDA, NDC, English brand, package image or label holder; every market requires separate checking against current local regulatory material." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "120、180、240、300、360、420 mg 能否按毫克数、瓶装数量或“同为地尔硫卓”自行互换？", "en": "Can 120, 180, 240, 300, 360 and 420 mg be self-exchanged by milligram number, bottle quantity or shared diltiazem name?" }, "answer": { "zh": "不能。它们是这份美国标签中分别列出的准确缓释片身份。网页不把产品数字变成个人片数、分片、咀嚼/研碎、补用、同日叠加、隔天轮换、替代或调整规则；请带着实际药盒、现行处方和完整药单交给药师或开方团队核对。", "en": "No. They are distinct extended-release tablet identities listed in this U.S. label. This page does not turn product numbers into individual tablet count, splitting, chewing/crushing, make-up use, same-day combination, alternate-day use, substitution or adjustment rules; take the actual pack, current prescription and complete medicine list to a pharmacist or prescribing team for review." } }, { "question": { "zh": "为什么本页强调“整片吞服”，却不告诉我是否能掰开或怎样换成另一种地尔硫卓？", "en": "Why does this page emphasise ‘swallow whole’ but not say whether I can split it or change to another diltiazem product?" }, "answer": { "zh": "当前标签对这一准确缓释片写有整片吞服、不可咀嚼或研碎的文字；但分片、吞咽困难、漏用、换剂型和转换涉及实际产品与个人处方。网页不应把标签中的处方转换资料变成自助操作；请由药师或开方团队按实际包装和完整药单确认。", "en": "The current label states that this exact extended-release tablet is swallowed whole and not chewed or crushed; however, splitting, swallowing difficulty, missed use, dosage-form changes and conversion involve the actual product and individual prescription. A webpage should not turn prescribing conversion text into self-service instructions; have a pharmacist or prescribing team confirm from the actual pack and complete medicine list." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "dosage-forms-are-part-of-medicine-identity", "how-to-read-a-drug-label" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/cardizem-la/", "en": "https://origindrug.com/en/drugs/cardizem-la/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "amiodarone-cordarone", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-26", "status": "published_traceable_archive" }, "names": { "brand": "CORDARONE", "generic": "胺碘酮", "aliases": [ "Cordarone", "胺碘酮", "盐酸胺碘酮", "amiodarone", "amiodarone hydrochloride", "CORDARONE" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "心血管", "sourceArchiveMarket": "美国：DailyMed 2018-10 患者用药指南与 FDA 2016 补充批准记录。均为有日期的公开历史资料；不代表中国大陆、欧盟、日本或其他市场的现行标签、供应或可替代性。", "dosageFormClass": "盐酸胺碘酮口服片：200 mg（美国历史公开资料所列）", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "1985（美国初始批准；仅定位美国历史资料）", "archiveSponsorText": "Wyeth Pharmaceuticals LLC（2018 DailyMed 文件所列）" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-cordarone-amiodarone-hydrochloride-tablet-200mg-historical-source-text", "marketCode": "US", "labelVersion": { "zh": "DailyMed 美国历史患者用药指南（2018-10 修订）", "en": "U.S. DailyMed historical Medication Guide (revised Oct 2018)" }, "dosageForm": { "zh": "CORDARONE 盐酸胺碘酮口服片（美国历史文件）", "en": "CORDARONE amiodarone hydrochloride oral tablet (historical U.S. document)" }, "route": { "zh": "口服（历史文件产品身份字段）", "en": "oral (historical-document product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "Historical U.S. document — no exact package panel established", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片盐酸胺碘酮 200 mg（美国历史文件的文字身份；未建立包装面板）", "en": "Amiodarone hydrochloride 200 mg per tablet (historical U.S. document text identity; no exact package panel established)" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "盐酸胺碘酮（每片）", "en": "amiodarone hydrochloride (per tablet)" }, "value": 200, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片历史文件标示量；不是个人片数、频率、分片或换药指令", "en": "Labelled amount per tablet in the historical document; not an individual's tablet count, frequency, splitting or switching instruction" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-26", "currentLabelDisplayed": false, "ndcDirectoryListed": false, "marketAvailability": "historical_label_record_only", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": null, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_2501cc572e4e60db", "label": "DailyMed（NLM）：CORDARONE 胺碘酮美国患者用药指南（Wyeth/Pfizer；2018-10 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/medguide.cfm?setid=51be39a2-9134-402c-95ad-defe47406ff8", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-26", "reviewedAt": "2026-08-26" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "status": "withheld_repackaged_or_non_exact_visual", "title": { "zh": "已核验有日期的历史美国文件，但未保留可一一对应的官方原品牌包装图，故不展示包装图片", "en": "Dated U.S. historical documents were reviewed, but no one-to-one official original-brand package image was retained, so no package visual is shown" }, "summary": { "zh": "本档案保留 CORDARONE、胺碘酮、口服片、200 mg、2018 年美国患者用药指南以及 FDA 历史批准资料。此次未保留可同时对应这一历史品牌、单一规格、单一包装和可公开展示的官方图片；为避免把零售图、再包装图、版本不明图、其他市场图片或另一种胺碘酮产品误作准确 CORDARONE 外观，页面不展示包装图片，只保留有日期的一手文件供放大阅读。", "en": "This dossier retains CORDARONE, amiodarone, oral tablets, 200 mg, the 2018 U.S. Medication Guide and FDA historical approval material. No official image was retained that can be matched at once to this dated brand, one strength and one package and safely displayed; to avoid treating a retail image, repackaged image, version-uncertain image, another-market image or another amiodarone product as the exact CORDARONE appearance, the page withholds package imagery and retains dated primary documents for enlarged reading." }, "source": { "id": "src_2501cc572e4e60db", "label": "DailyMed（NLM）：CORDARONE 胺碘酮美国患者用药指南（Wyeth/Pfizer；2018-10 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/medguide.cfm?setid=51be39a2-9134-402c-95ad-defe47406ff8", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-26", "reviewedAt": "2026-08-26" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "CORDARONE 说明书放大阅读：先把 200 mg 看成历史口服片身份，而不是个人片数", "en": "CORDARONE label reading: read 200 mg as a dated oral-tablet identity, not a personal tablet count" }, "summary": { "zh": "本模块使用美国 DailyMed 2018 年 CORDARONE 患者用药指南，帮助读者把品牌、胺碘酮、口服片、200 mg、文件日期和美国市场资料放在一起阅读。它不为任何人计算剂量，不给出开始、停止、漏服补用、分片、错开时间或与其他心律药同用的决定。", "en": "This module uses the 2018 U.S. DailyMed CORDARONE Medication Guide to read the brand, amiodarone, oral tablet, 200 mg, document date and U.S. record together. It does not calculate a dose or decide starting, stopping, missed-use handling, splitting, timing separation or co-use with another rhythm medicine for anyone." }, "checks": [ { "zh": "200 mg 是该美国历史文件中口服片的标示强度；它不是“每天几片”、两片能否相加、能否对半、漏服后如何补用或与另一种胺碘酮产品换算的公式。", "en": "200 mg is the labelled strength of the oral tablet in this dated U.S. document; it is not a formula for ‘how many per day’, adding tablets, halving, missed-use handling or converting to another amiodarone product." }, { "zh": "该患者用药指南把肺部、肝脏和心律相关严重问题列为需要专业监测的内容，并提示药物可能在停用后数月仍留在体内。这些信息说明为什么不能依据网页自行突然停药、恢复旧方案或改变时间表。", "en": "The Medication Guide identifies serious lung, liver and rhythm-related concerns requiring professional monitoring and notes that the medicine may remain in the body for months after stopping. This explains why a webpage cannot support suddenly stopping, restarting an old plan or changing a schedule." }, { "zh": "文件还要求把全部处方药、非处方药、维生素和草本补充剂告知专业人员。看到两个产品都与心律、心脏或血压有关，并不建立同日叠加、隔天轮换、替代或安全间隔的结论。", "en": "The document also asks people to disclose all prescription medicines, OTC products, vitamins and herbal supplements. Two products both relating to rhythm, heart or blood pressure do not establish same-day co-use, alternate-day use, substitution or a safe interval." }, { "zh": "本页所列文件已过其修订日期；若手上药盒来自中国大陆或其他市场，或药袋、说明书与本页不同，应带准确药盒与现行处方标签向发药药师或开方团队核对，而不是以历史美国资料替代。", "en": "The documents listed here are dated. If the pack is from mainland China or another market, or its dispensing label or leaflet differs from this page, take the exact pack and current prescription label to the dispensing pharmacist or prescribing team rather than substituting a dated U.S. document." } ], "source": { "id": "src_2501cc572e4e60db", "label": "DailyMed（NLM）：CORDARONE 胺碘酮美国患者用药指南（Wyeth/Pfizer；2018-10 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/medguide.cfm?setid=51be39a2-9134-402c-95ad-defe47406ff8", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-26", "reviewedAt": "2026-08-26" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "胺碘酮怎样起作用：药理分类帮助理解，不能用来安排个人心律用药", "en": "How amiodarone works: pharmacology helps explain a class, not arrange an individual rhythm-medicine plan" }, "summary": { "zh": "FDA 的历史 CORDARONE 资料将其描述为以 III 类作用为主的抗心律失常药，并说明它可延长心肌细胞动作电位与不应期。这里解释的是公开资料中的药理路径，不预测个人心律、是否适用、剂量、监测、联用或换药方案。", "en": "Historical FDA CORDARONE material describes it as an antiarrhythmic with predominantly Class III effects and explains that it can prolong myocardial action-potential duration and refractoriness. This is a public pharmacology pathway, not a prediction of an individual's rhythm, suitability, dose, monitoring, co-use or switching plan." }, "checks": [ { "zh": "“III 类抗心律失常药”是帮助理解文件的类别词，不是“心律不齐就能吃”或“同类药可以互换”的结论。病因、心电图、其他药物、肝肺甲状腺相关情况和准确标签都必须由专业人员共同评估。", "en": "‘Class III antiarrhythmic’ is a category term for reading the document, not a conclusion that it is suitable for an arrhythmia or interchangeable with another class member. Cause, ECG findings, other medicines, lung/liver/thyroid context and the exact label require professional assessment together." }, { "zh": "即使两个药都影响心律、心率或传导，也不能从机制文字推导出同服、隔天轮换、谁先停或按 mg 换算。请把所有实际药盒、药袋标签、非处方药和补充剂一起带去核对。", "en": "Even if two medicines affect rhythm, heart rate or conduction, mechanism text cannot determine co-use, alternate-day use, which one to stop first or milligram conversion. Take all actual packs, dispensing labels, OTC products and supplements together for review." }, { "zh": "出现昏厥、胸部不适、明显心悸、呼吸困难、严重头晕或其他急性担忧时，应使用当地紧急和医疗渠道；不要等待本页或根据机制说明自行改变药物。", "en": "With fainting, chest discomfort, marked palpitations, breathing difficulty, severe dizziness or another acute concern, use local urgent and medical care pathways rather than waiting for this page or self-changing a medicine from a mechanism explanation." } ], "source": { "id": "src_ee829b42b80b1fae", "label": "FDA：CORDARONE（胺碘酮）美国历史处方信息（2004-10；药理机制）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/018972s030_Cordarone_prntlbl.PDF", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-26", "reviewedAt": "2026-08-26" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "CORDARONE", "generic": "胺碘酮", "dosageFormClass": "盐酸胺碘酮口服片：200 mg（美国历史公开资料所列）" }, "labelSource": { "id": "src_2501cc572e4e60db", "label": "DailyMed（NLM）：CORDARONE 胺碘酮美国患者用药指南（Wyeth/Pfizer；2018-10 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/medguide.cfm?setid=51be39a2-9134-402c-95ad-defe47406ff8", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-26", "reviewedAt": "2026-08-26" }, "productRoutes": [ { "source": { "id": "src_2501cc572e4e60db", "label": "DailyMed（NLM）：CORDARONE 胺碘酮美国患者用药指南（Wyeth/Pfizer；2018-10 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/medguide.cfm?setid=51be39a2-9134-402c-95ad-defe47406ff8", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-26", "reviewedAt": "2026-08-26" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-26", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_15c3689b51c7b02f", "label": "FDA：CORDARONE 胺碘酮 200 mg 补充批准函（NDA 018972/S-051；2016-04）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/018972Orig1s051ltr.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-26", "reviewedAt": "2026-08-26" }, "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-08-26", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_9659163bae20721f", "label": "FDA：Cordarone／amiodarone HCl 孤儿药指定与营销批准记录", "url": "https://www.accessdata.fda.gov/scripts/opdlisting/oopd/detailedIndex.cfm?cfgridkey=77293", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-26", "reviewedAt": "2026-08-26" }, "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-08-26", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-26", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "本页将 CORDARONE、胺碘酮、口服片、200 mg 与美国有日期的公开文件放在一起，帮助先识别手中资料所对应的历史产品记录。它不把历史资料当作任何市场的当前说明书，也不把 mg、刻痕、同类心律药或网页文字转写为个人的片数、漏服补用、分片、联用、停用或换药方案。", "history": "FDA 的公开孤儿药记录列示 Cordarone（amiodarone HCl）于 1995 年获得所述美国营销批准；DailyMed 的 CORDARONE 患者用药指南修订于 2018 年。两者只能定位历史美国文件。实际药盒、批准状态、持有人、包装、规格与现行用法必须在使用地按当前官方记录另行核对。", "sourceDocuments": [ { "id": "src_2501cc572e4e60db", "label": "DailyMed（NLM）：CORDARONE 胺碘酮美国患者用药指南（Wyeth/Pfizer；2018-10 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/medguide.cfm?setid=51be39a2-9134-402c-95ad-defe47406ff8", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-26", "reviewedAt": "2026-08-26" }, { "id": "src_15c3689b51c7b02f", "label": "FDA：CORDARONE 胺碘酮 200 mg 补充批准函（NDA 018972/S-051；2016-04）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/018972Orig1s051ltr.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-26", "reviewedAt": "2026-08-26" }, { "id": "src_9659163bae20721f", "label": "FDA：Cordarone／amiodarone HCl 孤儿药指定与营销批准记录", "url": "https://www.accessdata.fda.gov/scripts/opdlisting/oopd/detailedIndex.cfm?cfgridkey=77293", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-26", "reviewedAt": "2026-08-26" } ], "applicationNumber": "NDA 018972（CORDARONE 胺碘酮 200 mg；FDA 有日期历史批准记录）", "approvalTimeline": [ { "date": "1985", "title": { "zh": "FDA 标签所列美国初始批准年份", "en": "Initial U.S. approval year listed in the FDA label" }, "detail": { "zh": "本页链接的 FDA 标签档案列示 Initial U.S. Approval: 1985。该历史定位不等同于当前批准、可得性、持有人或其他市场状态。", "en": "The FDA label archive linked here lists Initial U.S. Approval: 1985. This historical locator is not a conclusion about current approval, availability, holder or another market." }, "source": { "id": "src_2501cc572e4e60db", "label": "DailyMed: CORDARONE amiodarone U.S. Medication Guide (revised 2018-10)", "url": "https://dailymed.nlm.nih.gov/dailymed/medguide.cfm?setid=51be39a2-9134-402c-95ad-defe47406ff8", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-26", "reviewedAt": "2026-08-26" } }, { "date": "2018-10 dated DailyMed Medication Guide", "title": { "zh": "FDA 标签档案版本", "en": "FDA label archive version" }, "detail": { "zh": "本页链接 2018-10 dated DailyMed Medication Guide 的 FDA 标签档案作为可复核阅读入口。现行标签、规格、适应症和安全信息必须另行以目标市场当前文件核对。", "en": "This page links the 2018-10 dated DailyMed Medication Guide FDA label archive as a traceable reading entry point. Current labeling, strength, indication and safety information require separate verification against the target market’s current document." }, "source": { "id": "src_2501cc572e4e60db", "label": "DailyMed: CORDARONE amiodarone U.S. Medication Guide (revised 2018-10)", "url": "https://dailymed.nlm.nih.gov/dailymed/medguide.cfm?setid=51be39a2-9134-402c-95ad-defe47406ff8", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-26", "reviewedAt": "2026-08-26" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "已链接公开标签档案", "en": "Public label archive linked" }, "detail": { "zh": "仅对应本页所列 FDA 文件。", "en": "Only the FDA document listed on this page is linked." } }, { "market": { "zh": "中国大陆、欧盟、日本", "en": "Mainland China, EU, Japan" }, "status": { "zh": "待逐项建立市场记录", "en": "Market record not established" }, "detail": { "zh": "不从美国标签档案推定当地批准、持有人、规格、供应或可售资格。", "en": "No local approval, holder, strength, supply or sale-eligibility conclusion is inferred from the U.S. label archive." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "标签档案能代表现在的产品信息吗？", "en": "Does a label archive represent current product information?" }, "answer": { "zh": "不能自动代表。档案用于定位来源；需要以目标市场的现行官方标签逐项复核。", "en": "Not automatically. The archive locates a source; each point needs verification against the target market’s current official label." } }, { "question": { "zh": "为什么这里不展示价格或原研/仿制结论？", "en": "Why are price and originator/generic conclusions not shown?" }, "answer": { "zh": "这些结论需要产品、剂型、规格、包装、市场、日期和原始记录分别齐全并经人工审核；单一标签文件不足以支持。", "en": "Those conclusions require separately complete and human-reviewed product, dosage-form, strength, pack, market, date and primary-record fields; one label file is insufficient." } } ], "relatedMedicineChecks": [ { "target": { "id": "coumadin", "brand": "Coumadin", "generic": "华法林钠", "canonicalUrls": { "zh": "https://origindrug.com/drugs/coumadin/", "en": "https://origindrug.com/en/drugs/coumadin/" } }, "title": { "zh": "与 COUMADIN／华法林同在药单上时：这是需要专业监测的高风险核对项", "en": "When COUMADIN / warfarin is on the same list: this is a high-risk professional-monitoring check" }, "summary": { "zh": "当前美国胺碘酮通用名标签明确列出与华法林的相互作用，并提示胺碘酮停用后相互作用仍可能持续数周至数月。本卡片只提示尽快把两种实际药盒、当前说明书、监测记录和完整药单交给开方团队、药师或抗凝管理团队核对；它不判断能否同用，不提供 INR 目标、剂量、给药间隔或停换药方案，也不建议自行停用、错开时间、替换或调整任何一种药。CORDARONE 本页是历史品牌档案，所引当前通用名标签不能证明该品牌当前供应或市场状态。", "en": "A current U.S. generic amiodarone label identifies an interaction with warfarin and notes that interactions can persist for weeks to months after amiodarone is stopped. This card only signals that both actual packs, current labels, monitoring records and the complete medicine list need prompt review by the prescribing team, pharmacist or anticoagulation service; it does not decide co-use, provide an INR target, dose, timing interval or stop/switch plan, or advise self-stopping, time-separation, replacement or adjustment of either medicine. This CORDARONE page is a historical brand archive; the cited current generic label does not establish current brand supply or market status." }, "source": { "id": "src_115d36855c37f0e1", "label": "DailyMed（NLM）：胺碘酮当前美国通用名标签（华法林相互作用；仅作成分层核对，不代表 CORDARONE 当前市场状态）", "url": "https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=28cd0224-3569-4308-bd40-480bc4230503&type=display", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-05", "reviewedAt": "2026-09-05" }, "scope": "review_complete_medicine_list_no_self_directed_change" }, { "target": { "id": "lanoxin", "brand": "Lanoxin", "generic": "地高辛", "canonicalUrls": { "zh": "https://origindrug.com/drugs/lanoxin/", "en": "https://origindrug.com/en/drugs/lanoxin/" } }, "title": { "zh": "与 LANOXIN／地高辛同在药单上时：地高辛浓度与心率／传导都要专业核对", "en": "When LANOXIN / digoxin is on the same list: digoxin concentration and rate/conduction need professional review" }, "summary": { "zh": "当前美国胺碘酮通用名标签说明胺碘酮可升高地高辛浓度，并把地高辛列为可能增强心动过缓、窦性停搏和房室传导阻滞风险线索的负性变时药；当前 LANOXIN 片剂标签还说明地高辛的中毒浓度只略高于治疗浓度，年龄、体重、肾功能和联用药都需要纳入专业判断。本卡只要求尽快把两种实际药盒、完整药单、近期肾功能／电解质、心率或心电记录及既有地高辛监测结果交给开方团队或药师核对；它不判断能否同用，不提供浓度目标、减量比例、给药间隔、停药或换药方案，也不建议自行错开、掰片、漏服补用或调整任何一种药。CORDARONE 页面属于历史品牌档案；当前通用名标签不证明该品牌当前供应。", "en": "A current U.S. generic amiodarone label says amiodarone can increase digoxin concentration and lists digoxin as a negative chronotrope that can add to bradycardia, sinus arrest and AV block. The current U.S. LANOXIN tablet label also says toxic digoxin concentrations are only slightly higher than therapeutic concentrations, and that age, body weight, renal function and concomitant medicines matter in professional decisions. This card only calls for prompt review of both actual packs, the complete medicine list, recent kidney-function/electrolyte information, heart-rate or ECG records and any existing digoxin-monitoring results by the prescribing team or pharmacist. It does not decide co-use or provide a concentration target, reduction percentage, timing interval, stop or switch plan, and does not advise self-separation, tablet splitting, catch-up use or adjustment of either medicine. The CORDARONE page is a historical brand archive; a current generic label does not establish current brand supply." }, "source": { "id": "src_115d36855c37f0e1", "label": "DailyMed（NLM）：胺碘酮当前美国通用名标签（地高辛浓度与心率／传导相互作用；不代表 CORDARONE 当前供应）", "url": "https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=28cd0224-3569-4308-bd40-480bc4230503&type=display", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-05", "reviewedAt": "2026-09-05" }, "scope": "review_complete_medicine_list_no_self_directed_change" } ], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "how-to-read-a-drug-label", "regulatory-sources-first" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/amiodarone-cordarone/", "en": "https://origindrug.com/en/drugs/amiodarone-cordarone/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "omeprazole-prilosec", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-21", "status": "published_traceable_archive" }, "names": { "brand": "Prilosec OTC", "generic": "奥美拉唑", "aliases": [ "Prilosec", "洛赛克", "omeprazole" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": { "value": "洛赛克®", "status": "discovery_cue_requires_target_market_verification", "source": null } }, "identity": { "therapeuticArea": "消化系统", "sourceArchiveMarket": "美国 PRILOSEC OTC 非处方公开标签（DailyMed SPL v2，2025-06-10 生效/2025-06-12 发布）", "dosageFormClass": "奥美拉唑镁延迟释放片（非处方）：本档案精确展示 20 mg、42 片纸盒；不并入 PRILOSEC 处方延迟释放胶囊", "dosageFormClassCode": "oral_modified_release", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "1989", "archiveSponsorText": "AstraZeneca / P&G（本页仅建立 P&G PRILOSEC OTC 标签身份）" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [ "PRILOSEC delayed-release capsule", "PRILOSEC capsule", "PRILOSEC 20 mg capsule", "奥美拉唑肠溶胶囊" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-prilosec-otc-tablet-20mg-84126-301-42", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v2（2025-06-10 生效；2025-06-12 发布）", "en": "DailyMed SPL v2 (effective 10 Jun 2025; published 12 Jun 2025)" }, "dosageForm": { "zh": "奥美拉唑镁延迟释放片（非处方）", "en": "omeprazole magnesium delayed-release tablet (OTC)" }, "route": { "zh": "口服（仅作标签产品身份字段）", "en": "oral (label product-identity field only)" }, "routeCodes": [ "oral" ], "productCode": "NDC 84126-301-42", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片 20 mg；42 片纸盒（3 板 × 14 片）", "en": "20 mg per tablet; 42-tablet carton (3 blisters × 14 tablets)" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=301.jpg&setid=c7229a69-07e7-4690-8fc0-1f0f093bf230&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "奥美拉唑（延迟释放片）", "en": "omeprazole delayed-release tablet" }, "value": 20, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人服用片数、疗程或换算指令", "en": "labelled amount per tablet; not an individual tablet count, course or conversion instruction" } } ], "concentration": null, "container": { "typeCode": "carton", "typeLabel": { "zh": "纸盒", "en": "carton" }, "fill": null, "countPerPackage": 42, "countUnit": { "zh": "片/盒", "en": "tablets per carton" }, "unitsPerContainer": { "count": 14, "unit": { "zh": "片/泡罩板", "en": "tablets per blister" } } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-21", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 42, "unit": { "zh": "片/盒", "en": "tablets per carton" } }, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_4c50d84de0d65431", "label": "DailyMed（NLM）：PRILOSEC OTC 奥美拉唑镁延迟释放片公开标签（P&G；SPL v2）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c7229a69-07e7-4690-8fc0-1f0f093bf230", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-prilosec-otc-tablet-20mg-84126-301-42", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=301.jpg&setid=c7229a69-07e7-4690-8fc0-1f0f093bf230&type=img", "alt": "PRILOSEC OTC 奥美拉唑镁 20 mg 延迟释放片在美国 DailyMed SPL v2 中的 42 片纸盒主展示面", "archiveMarket": "美国", "labelVersion": "DailyMed SPL v2（2025-06-10 生效；2025-06-12 发布）", "presentation": "PRILOSEC OTC（奥美拉唑镁）20 mg 延迟释放片、42 片纸盒（3 板 × 14 片；NDC 84126-301-42；DailyMed SPL v2 所列）。", "notice": "此图只对应美国 DailyMed SPL v2 中 PRILOSEC OTC 20 mg 延迟释放片、NDC 84126-301-42、42 片纸盒（3 板 × 14 片），只帮助核对品牌、活性成分文字、标示强度、剂型、包装数量与来源；不用于鉴定真伪，也不证明 PRILOSEC 处方胶囊、其他奥美拉唑剂型、其他包装、其他市场标签、原研身份、目标市场批准或可售资格。", "source": { "id": "src_4c50d84de0d65431", "label": "DailyMed（NLM）：PRILOSEC OTC 奥美拉唑镁延迟释放片公开标签（P&G；SPL v2）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c7229a69-07e7-4690-8fc0-1f0f093bf230", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "PRILOSEC OTC 说明书放大阅读：本页的延迟释放片不等于同名处方胶囊", "en": "PRILOSEC OTC label reading: this delayed-release tablet is not the same product as a same-name prescription capsule" }, "summary": { "zh": "本模块先以美国 DailyMed 2025 PRILOSEC OTC 延迟释放片为精确包装阅读入口，再用 FDA 2010 历史资料说明同名处方胶囊和缓释口服混悬液为何不能混同；不把标签中的治疗表转化为个人处方或自行用药指令。", "en": "This module first uses the U.S. 2025 DailyMed PRILOSEC OTC delayed-release tablet as the exact pack-reading entry point, then uses a 2010 FDA historical record to explain why same-name prescription capsules and delayed-release oral suspension cannot be merged. It does not turn label treatment tables into an individual prescription or self-use instruction." }, "checks": [ { "zh": "本页精确展示的是 PRILOSEC OTC 延迟释放片 20 mg、42 片纸盒（3 板 × 14 片）。它不代表 PRILOSEC 处方延迟释放胶囊、缓释口服混悬液或其他奥美拉唑产品；同名、同为 20 mg 或包装数字相近，都不表示可自行互换。", "en": "This page precisely displays PRILOSEC OTC delayed-release tablets, 20 mg, in a 42-tablet carton (3 blisters × 14 tablets). It does not represent PRILOSEC prescription delayed-release capsules, delayed-release oral suspension or another omeprazole product; a shared name, 20 mg strength or similar package number does not make products self-interchangeable." }, { "zh": "“缓释/肠溶”描述的是制剂如何设计释放和通过胃部环境，不是“效果更强”或“可以把一颗掰成两次吃”的通用结论。是否能打开、撒服、掰开、研碎或改用另一剂型，只能按该准确产品的现行标签和药师指导确认。", "en": "“Delayed release/enteric” describes how a formulation is designed to release and pass through the stomach environment; it does not mean “stronger” or that one unit can generally be split for two uses. Opening, sprinkling, splitting, crushing or changing form can only be confirmed from the current label for that exact product and a pharmacist." }, { "zh": "该标签还列出多种可能受胃酸或代谢途径影响的联用药物。正在使用抗血小板、抗凝、抗癫痫、抗病毒、免疫抑制或其他处方药时，应带完整药单请药师核对，不要因网络上看到“胃药相互作用”而自行停用、替换或加药。", "en": "The label also lists several co-medications that may be affected through gastric acidity or metabolic pathways. When antiplatelet, anticoagulant, antiseizure, antiviral, immunosuppressant or other prescription medicines are used, bring the complete list to a pharmacist; do not self-stop, replace or add a medicine because an online page mentions a “stomach-medicine interaction.”" }, { "zh": "本页的精确包装来自美国 2025 OTC 标签，而用于说明处方胶囊/混悬液区别的 FDA 文件是 2010 历史资料；两者都不能证明中国或其他市场的现行规格、包装、适应症或可获得性。出现吞咽困难、呕血、黑便、胸痛等健康问题时不应只靠网页自行判断。", "en": "The exact pack on this page comes from a U.S. 2025 OTC label, while the FDA document used to distinguish prescription capsules and suspension is a 2010 historical record. Neither establishes current strengths, packaging, indications or availability in China or another market. Swallowing difficulty, vomiting blood, black stools or chest pain are not situations for self-assessment from a webpage." } ], "source": { "id": "src_0f7991f28ecf7d2e", "label": "FDA：PRILOSEC 2010-08 处方信息（缓释剂型、规格与相互作用）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019810s090%2C022056s005lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "奥美拉唑怎样起作用：它作用于胃壁细胞的“质子泵”", "en": "How omeprazole works: it acts on the gastric parietal-cell “proton pump”" }, "summary": { "zh": "FDA 的 PRILOSEC 公开药理资料描述：奥美拉唑通过特异性抑制胃壁细胞分泌表面的 H⁺/K⁺ ATPase 酶系统来抑制胃酸分泌；这一系统常被称为胃黏膜中的“质子泵”。这解释的是药物作用路径，不是针对任何个人症状、疗程、胶囊数或联用安排的答案。", "en": "FDA public PRILOSEC pharmacology material describes omeprazole as suppressing gastric acid secretion through specific inhibition of the H⁺/K⁺ ATPase enzyme system at the secretory surface of the gastric parietal cell, often called the gastric “proton pump.” It explains a drug-action pathway, not an answer for an individual's symptoms, course, capsule count or combination plan." }, "checks": [ { "zh": "把“质子泵”理解为胃酸生成路径中的一个末端环节即可。它说明为什么奥美拉唑属于抑酸药，但不能从机制反推某个人胃痛、反酸、咳嗽或胸部不适的原因，更不能替代诊断和目标市场的现行标签。", "en": "Read the “proton pump” as one final step in gastric-acid production. It explains why omeprazole is an acid-suppression medicine, but it cannot infer the cause of a person's stomach pain, reflux, cough or chest discomfort, or replace diagnosis and the current target-market label." }, { "zh": "肠溶/缓释胶囊与缓释口服混悬液都可能含奥美拉唑，却有不同的剂型、单位与操作要求。共同机制不让它们自动变成相同的胶囊数、毫升数或可随意打开、掰开、研碎和互换的产品。", "en": "Delayed-release capsules and delayed-release oral suspension can both contain omeprazole while having different forms, units and handling requirements. A shared mechanism does not make them the same capsule count or millilitre amount, or products that can be freely opened, split, crushed or exchanged." }, { "zh": "PRILOSEC 标签列有需要复核的联用药物；PLAVIX 现行美国标签还特别提示奥美拉唑或埃索美拉唑可能降低其抗血小板活性。这个关联应促使带完整药单请药师或开方团队核对，而不是在网上看到后自行突然停用、错开时间或替换任何一种药。", "en": "The PRILOSEC label lists medicines requiring co-medication review, and the current U.S. PLAVIX label specifically warns that omeprazole or esomeprazole can reduce its antiplatelet activity. This connection should prompt review of the complete medicine list with a pharmacist or prescriber, not a sudden self-stop, timing change or replacement of either medicine after reading online." } ], "source": { "id": "src_b96c539794d3017b", "label": "FDA：PRILOSEC 公开药理资料（Mechanism of Action）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19810se8-058%2Cslr003_prilosec_lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "Prilosec OTC", "generic": "奥美拉唑", "dosageFormClass": "奥美拉唑镁延迟释放片（非处方）：本档案精确展示 20 mg、42 片纸盒；不并入 PRILOSEC 处方延迟释放胶囊" }, "labelSource": { "id": "src_0f7991f28ecf7d2e", "label": "FDA：PRILOSEC 2010-08 处方信息", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019810s090%2C022056s005lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "productRoutes": [ { "source": { "id": "src_0f7991f28ecf7d2e", "label": "FDA：PRILOSEC 2010-08 处方信息", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019810s090%2C022056s005lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_4c50d84de0d65431", "label": "DailyMed（NLM）：PRILOSEC OTC 奥美拉唑镁延迟释放片公开标签（P&G；SPL v2）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c7229a69-07e7-4690-8fc0-1f0f093bf230", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [ { "id": "fda-2012-ppi-cdad-prilosec-otc-safety-communication", "issuedAt": "2012-02-08", "status": "fda_class_safety_communication", "title": { "zh": "FDA 药物安全通讯：包括 Prilosec OTC 在内的 PPI 与艰难梭菌相关性腹泻风险沟通", "en": "FDA Drug Safety Communication: C. difficile-associated diarrhoea communication for PPIs including Prilosec OTC" }, "summary": { "zh": "FDA 于 2012-02-08 发布质子泵抑制剂（PPI）类别安全通讯，说明该类胃酸抑制药与艰难梭菌相关性腹泻（CDAD）风险增加可能有关；FDA 当前 OTC 胃灼热页面将 Prilosec OTC（奥美拉唑镁）列为 PPI，并链接该安全通讯。此记录是美国、特定日期的类别沟通，不能诊断腹泻原因，不能推断手中 PRILOSEC OTC 20 mg 延迟释放片、处方奥美拉唑、其他 PPI 或其他市场产品的个人风险，也不支持自行停用、加减、延长疗程或更换酸抑制药。持续不改善的腹泻或其他急性不适应及时寻求当地医疗支持，并让药师或开方团队核对实际包装、完整用药清单和现行标签。", "en": "On 2012-02-08, FDA issued a class Drug Safety Communication saying that proton-pump inhibitors (PPIs), a group of stomach-acid medicines, may be associated with increased risk of Clostridioides difficile-associated diarrhoea (CDAD). FDA’s current OTC heartburn page lists Prilosec OTC (omeprazole magnesium) as a PPI and links this communication. This is a dated U.S. class communication: it cannot diagnose a cause of diarrhoea, determine individual risk for PRILOSEC OTC 20 mg delayed-release tablets, prescription omeprazole, another PPI or another market, or support self-stopping, dose changes, extending a course or switching acid-reducing medicines. Diarrhoea that does not improve or another acute concern needs prompt local medical support and review of the actual pack, complete medicine list and current label with a pharmacist or prescribing team." }, "source": { "id": "src_16fec3b73d115843", "label": "FDA：2012-02-08 PPI 与艰难梭菌相关性腹泻药物安全通讯（Prilosec OTC 列于 FDA 当前 PPI 页面）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/anda/2012/202194Orig1s000.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "本页精确建立美国 PRILOSEC OTC（omeprazole magnesium）20 mg 延迟释放片、42 片纸盒的标签阅读身份；不把同名 PRILOSEC 处方延迟释放胶囊、其他奥美拉唑胶囊、其他包装或其他市场产品混为同一产品。页面不构成诊疗、疗程、处方、购买或当前可得性建议。", "history": "PRILOSEC 是奥美拉唑品牌历史中的名称线索，但本档案的精确产品卡只对应美国 DailyMed 所列 PRILOSEC OTC 延迟释放片。剂型、包装、适应症与可及性均应以所在市场的当前监管资料为准。", "sourceDocuments": [ { "id": "src_4c50d84de0d65431", "label": "DailyMed（NLM）：PRILOSEC OTC 奥美拉唑镁延迟释放片公开标签（P&G；SPL v2）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c7229a69-07e7-4690-8fc0-1f0f093bf230", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_0f7991f28ecf7d2e", "label": "FDA：PRILOSEC 2010-08 处方信息", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019810s090%2C022056s005lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_5ed30b676fbb9773", "label": "FDA Drugs@FDA", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_lookup_entry", "documentKind": "regulatory_lookup", "market": "US", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } ], "applicationNumber": "NDA 019810 / 022056", "approvalTimeline": [ { "date": "1989", "title": { "zh": "FDA 标签所列美国初始批准年份", "en": "Initial U.S. approval year listed in the FDA label" }, "detail": { "zh": "本页链接的 FDA 标签档案列示 Initial U.S. Approval: 1989。该历史定位不等同于当前批准、可得性、持有人或其他市场状态。", "en": "The FDA label archive linked here lists Initial U.S. Approval: 1989. This historical locator is not a conclusion about current approval, availability, holder or another market." }, "source": { "id": "src_4188c446359491f2", "label": "FDA: PRILOSEC label archive", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019810s090,022056s005lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, { "date": "2010", "title": { "zh": "FDA 标签档案版本", "en": "FDA label archive version" }, "detail": { "zh": "本页链接 2010 的 FDA 标签档案作为可复核阅读入口。现行标签、规格、适应症和安全信息必须另行以目标市场当前文件核对。", "en": "This page links the 2010 FDA label archive as a traceable reading entry point. Current labeling, strength, indication and safety information require separate verification against the target market’s current document." }, "source": { "id": "src_4188c446359491f2", "label": "FDA: PRILOSEC label archive", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019810s090,022056s005lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "已链接公开标签档案", "en": "Public label archive linked" }, "detail": { "zh": "仅对应本页所列 FDA 文件。", "en": "Only the FDA document listed on this page is linked." } }, { "market": { "zh": "中国大陆、欧盟、日本", "en": "Mainland China, EU, Japan" }, "status": { "zh": "待逐项建立市场记录", "en": "Market record not established" }, "detail": { "zh": "不从美国标签档案推定当地批准、持有人、规格、供应或可售资格。", "en": "No local approval, holder, strength, supply or sale-eligibility conclusion is inferred from the U.S. label archive." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "标签档案能代表现在的产品信息吗？", "en": "Does a label archive represent current product information?" }, "answer": { "zh": "不能自动代表。档案用于定位来源；需要以目标市场的现行官方标签逐项复核。", "en": "Not automatically. The archive locates a source; each point needs verification against the target market’s current official label." } }, { "question": { "zh": "为什么这里不展示价格或原研/仿制结论？", "en": "Why are price and originator/generic conclusions not shown?" }, "answer": { "zh": "这些结论需要产品、剂型、规格、包装、市场、日期和原始记录分别齐全并经人工审核；单一标签文件不足以支持。", "en": "Those conclusions require separately complete and human-reviewed product, dosage-form, strength, pack, market, date and primary-record fields; one label file is insufficient." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "how-to-read-a-drug-label", "regulatory-sources-first" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/omeprazole-prilosec/", "en": "https://origindrug.com/en/drugs/omeprazole-prilosec/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "entecavir-baraclude", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-21", "status": "published_traceable_archive" }, "names": { "brand": "Baraclude", "generic": "恩替卡韦", "aliases": [ "博路定", "entecavir" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": { "value": "博路定®", "status": "discovery_cue_requires_target_market_verification", "source": { "id": "src_3823f8c9f3b5ecb5", "label": "BMS China：博路定（恩替卡韦片）历史公开资料（2017）", "url": "https://www.bms.com/cn/media/press-release-listing/-17082017.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "first_party_release", "market": "CN", "accessStatus": "public_access_with_site_controls", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } } }, "identity": { "therapeuticArea": "感染", "sourceArchiveMarket": "美国 DailyMed 有日期公开标签资料（SPL v42：2019-11-06 生效，2025-12-22 发布）", "dosageFormClass": "口服薄膜衣片（0.5 mg、1 mg）及即用型口服溶液（0.05 mg/mL；有日期美国公开标签所列）", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "2005（DailyMed 美国标签所列初始批准）", "archiveSponsorText": "E.R. Squibb & Sons / DailyMed 美国公开标签资料" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-baraclude-tablet-0-5mg-30-tablet-bottle-ndc-0003-1611-12", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v42（2019-11-06 生效；2025-12-22 发布）；有日期的美国公开标签资料，不代表当前供应", "en": "DailyMed SPL v42 (effective 6 Nov 2019; published 22 Dec 2025); dated U.S. public-label record, not availability" }, "dosageForm": { "zh": "BARACLUDE 恩替卡韦口服薄膜衣片", "en": "BARACLUDE entecavir oral film-coated tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 0003-1611-12", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片 0.5 mg；30 片儿童安全瓶装", "en": "0.5 mg per tablet; 30-tablet child-resistant bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=046e61c9-9298-4b2e-b76e-b26b81fecd20&name=barac-30ct-halfmg-car.jpg", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "恩替卡韦", "en": "entecavir" }, "value": 0.5, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、疗程或与口服溶液自行换算", "en": "labelled amount per tablet; not an individual's tablet count, course or self-conversion to oral solution" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "儿童安全瓶装", "en": "child-resistant bottle" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-21", "currentLabelDisplayed": false, "ndcDirectoryListed": false, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 30, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "白色至类白色", "en": "white to off-white" }, "shape": { "zh": "三角形薄膜衣片", "en": "triangular film-coated tablet" }, "imprint": "BMS / 1611", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_71117a23bfe61907", "label": "DailyMed（NLM）：BARACLUDE 有日期美国公开标签（E.R. Squibb & Sons；SPL v42）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=046e61c9-9298-4b2e-b76e-b26b81fecd20", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-baraclude-tablet-1mg-30-tablet-bottle-ndc-0003-1612-12", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v42（2019-11-06 生效；2025-12-22 发布）；有日期的美国公开标签资料，不代表当前供应", "en": "DailyMed SPL v42 (effective 6 Nov 2019; published 22 Dec 2025); dated U.S. public-label record, not availability" }, "dosageForm": { "zh": "BARACLUDE 恩替卡韦口服薄膜衣片", "en": "BARACLUDE entecavir oral film-coated tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 0003-1612-12", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片 1 mg；30 片儿童安全瓶装", "en": "1 mg per tablet; 30-tablet child-resistant bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=046e61c9-9298-4b2e-b76e-b26b81fecd20&name=barac-30ct-1mg-car.jpg", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "恩替卡韦", "en": "entecavir" }, "value": 1, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、疗程或与 0.5 mg 片/口服溶液自行换算", "en": "labelled amount per tablet; not an individual's tablet count, course or self-conversion to 0.5 mg tablets/oral solution" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "儿童安全瓶装", "en": "child-resistant bottle" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-21", "currentLabelDisplayed": false, "ndcDirectoryListed": false, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 30, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "粉红色", "en": "pink" }, "shape": { "zh": "三角形薄膜衣片", "en": "triangular film-coated tablet" }, "imprint": "BMS / 1612", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_71117a23bfe61907", "label": "DailyMed（NLM）：BARACLUDE 有日期美国公开标签（E.R. Squibb & Sons；SPL v42）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=046e61c9-9298-4b2e-b76e-b26b81fecd20", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-baraclude-oral-solution-0-05mg-per-ml-210ml-bottle-ndc-0003-1614-12", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v42（2019-11-06 生效；2025-12-22 发布）；有日期的美国公开标签资料，不代表当前供应", "en": "DailyMed SPL v42 (effective 6 Nov 2019; published 22 Dec 2025); dated U.S. public-label record, not availability" }, "dosageForm": { "zh": "BARACLUDE 恩替卡韦即用型口服溶液", "en": "BARACLUDE entecavir ready-to-use oral solution" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 0003-1614-12", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "concentration", "primaryDisplay": { "zh": "0.05 mg/mL；210 mL 儿童安全瓶装", "en": "0.05 mg/mL; 210 mL child-resistant bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=046e61c9-9298-4b2e-b76e-b26b81fecd20&name=barac-os-halfmgml-car.jpg", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "恩替卡韦", "en": "entecavir" }, "value": 0.05, "unit": "mg", "basisCode": "concentration", "basisLabel": { "zh": "标签浓度；不是个人毫升数、量具用法或与片剂自行换算", "en": "labelled concentration; not an individual's millilitres, measuring-device instruction or self-conversion to tablets" } } ], "concentration": { "basisCode": "mass_per_volume", "notation": "0.05 mg/mL", "numerator": { "value": 0.05, "unit": "mg" }, "denominator": { "value": 1, "unit": "mL" }, "display": { "zh": "0.05 mg/mL（标签浓度；不是个人毫升数）", "en": "0.05 mg/mL (labelled concentration; not an individual's millilitres)" } }, "container": { "typeCode": "bottle", "typeLabel": { "zh": "儿童安全瓶装", "en": "child-resistant bottle" }, "fill": { "value": 210, "unit": "mL" }, "countPerPackage": 1, "countUnit": { "zh": "瓶/盒", "en": "bottle per carton" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-21", "currentLabelDisplayed": false, "ndcDirectoryListed": false, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 1, "unit": { "zh": "瓶/盒", "en": "bottle per carton" } }, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_71117a23bfe61907", "label": "DailyMed（NLM）：BARACLUDE 有日期美国公开标签（E.R. Squibb & Sons；SPL v42）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=046e61c9-9298-4b2e-b76e-b26b81fecd20", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-baraclude-tablet-0-5mg-30-tablet-bottle-ndc-0003-1611-12", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=046e61c9-9298-4b2e-b76e-b26b81fecd20&name=barac-30ct-halfmg-car.jpg", "alt": "BARACLUDE 0.5 mg 恩替卡韦片在美国 DailyMed SPL v42 公开标签中的 30 片包装展示面", "archiveMarket": "美国", "labelVersion": "DailyMed SPL v42（2019-11-06 生效；2025-12-22 发布）", "presentation": "BARACLUDE 0.5 mg、30 片儿童安全瓶装展示面（有日期美国公开标签所列）。", "notice": "此为美国 DailyMed SPL v42 中明确对应 BARACLUDE 0.5 mg、30 片瓶装的包装展示面，只帮助核对品牌、通用名、标示强度、片剂、NDC、包装数量和来源；不用于鉴定真伪，也不证明 1 mg、口服溶液、其他包装、其他市场标签、当前供应、原研身份、目标市场批准或可售资格。", "source": { "id": "src_71117a23bfe61907", "label": "DailyMed（NLM）：BARACLUDE 有日期美国公开标签（片剂、口服溶液与包装面板；SPL v42）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=046e61c9-9298-4b2e-b76e-b26b81fecd20", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "BARACLUDE / 恩替卡韦说明书放大阅读：片剂、口服溶液与“不能自行停用”", "en": "BARACLUDE label reading: tablets, oral solution and why not to self-stop" }, "summary": { "zh": "本模块以 DailyMed 的 BARACLUDE 美国公开标签为阅读入口，帮助核对品牌、恩替卡韦、片剂/口服溶液、0.5 mg、1 mg、0.05 mg/mL 和包装文字；它不把这些信息转换为任何人的治疗、换药、加减量或停药方案。", "en": "This module uses the U.S. DailyMed BARACLUDE public label as a reading entry point. It helps check the brand, entecavir, tablet/oral solution, 0.5 mg, 1 mg, 0.05 mg/mL and package text; it does not convert these into anyone's treatment, switch, dose change or stopping plan." }, "checks": [ { "zh": "0.5 mg、1 mg 是标签列示的片剂标示强度；0.05 mg/mL 是口服溶液浓度。mg、mg/mL、片数和毫升数不是同一个单位，不能因包装数字相近而自行换算、替代或加减。", "en": "0.5 mg and 1 mg are labelled tablet strengths; 0.05 mg/mL is the oral-solution concentration. mg, mg/mL, tablet count and millilitre amount are not the same unit and cannot be self-converted, substituted or adjusted because package numbers look similar." }, { "zh": "DailyMed 标签的 0.5 mg 片剂包装图只能对应这一个美国代表性包装。它不能确认来自其他市场、其他规格、口服溶液或仿制产品的外观、批准状态或真实性。", "en": "The DailyMed 0.5 mg tablet image only corresponds to that one representative U.S. package. It cannot confirm the appearance, approval status or authenticity of another market, strength, oral solution or generic product." }, { "zh": "该标签提示停止抗乙型肝炎治疗后可能出现严重急性加重。任何漏服、想停用、换产品或担心不适的情况，都应带实际包装和完整药单联系开方团队或药师；不要以网页或包装图自行决定下一步。", "en": "The label warns that severe acute exacerbations can occur after anti-hepatitis B therapy is stopped. With a missed dose, a wish to stop, a product change or symptoms, take the actual package and complete medicine list to the prescribing team or pharmacist; do not decide the next step from a webpage or package image." }, { "zh": "标签列有肾功能相关的产品信息，也提到部分移植后或免疫抑制治疗情境需要专业评估。年龄、其他疾病或同时服用的药物都不能靠网页自动换成个人用法；应由专业人员结合准确产品和现行标签核对。", "en": "The label includes kidney-function-related product information and notes circumstances involving some post-transplant or immunosuppressive treatment that require professional assessment. Age, conditions or concomitant medicines cannot be converted by a webpage into an individual regimen; a professional must check the exact product and current label." } ], "source": { "id": "src_71117a23bfe61907", "label": "DailyMed（NLM）：BARACLUDE 有日期美国公开标签（剂型、强度与警告；SPL v42）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=046e61c9-9298-4b2e-b76e-b26b81fecd20", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "恩替卡韦怎样起作用：它在细胞内影响乙肝病毒逆转录酶的多个步骤", "en": "How entecavir works: it affects multiple steps of hepatitis B virus reverse transcriptase inside cells" }, "summary": { "zh": "DailyMed 标签说明，恩替卡韦是对乙型肝炎病毒逆转录酶有活性的脱氧鸟苷核苷类似物；被磷酸化为活性三磷酸形式后，可竞争性影响病毒逆转录酶的多个活动。这解释药理路径，不预测个人病毒学指标、适用性、疗程、片数或停药时机。", "en": "The DailyMed label explains that entecavir is a deoxyguanosine nucleoside analogue active against hepatitis B virus reverse transcriptase. After phosphorylation to its active triphosphate form, it competitively affects multiple reverse-transcriptase activities. This explains a pharmacologic pathway; it does not predict an individual's virologic markers, suitability, course, tablet count or stopping time." }, "checks": [ { "zh": "“影响乙肝病毒逆转录酶”只说明一条病毒复制相关路径，不能由此判断任何人的感染阶段、化验结果或是否需要开始、继续或停用治疗。", "en": "‘Affects hepatitis B virus reverse transcriptase’ describes one replication-related pathway only; it cannot determine anyone's infection stage, laboratory result or whether treatment should start, continue or stop." }, { "zh": "片剂与口服溶液可以含同一活性成分，却有不同剂型、标示单位和现行标签信息。共同机制不使它们成为可自行按片数或毫升数换算、交替或替代的产品。", "en": "Tablets and oral solution can contain the same active ingredient while having different forms, labelled units and current-label information. A shared mechanism does not make them products that can be self-converted by tablet count or millilitres, alternated or substituted." }, { "zh": "机制页面也不能用来处理漏服、停止、联合用药或移植后用药的决定。任何此类问题应使用目标市场的现行标签，并由熟悉完整药单和临床情况的专业人员复核。", "en": "A mechanism page also cannot resolve decisions about missed doses, stopping, combinations or post-transplant use. Such questions require the current target-market label and professional review by someone familiar with the complete medicine list and clinical context." } ], "source": { "id": "src_71117a23bfe61907", "label": "DailyMed（NLM）：BARACLUDE 有日期美国公开标签（微生物学；SPL v42）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=046e61c9-9298-4b2e-b76e-b26b81fecd20", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "Baraclude", "generic": "恩替卡韦", "dosageFormClass": "口服薄膜衣片（0.5 mg、1 mg）及即用型口服溶液（0.05 mg/mL；有日期美国公开标签所列）" }, "labelSource": { "id": "src_71117a23bfe61907", "label": "DailyMed（NLM）：BARACLUDE 有日期美国公开标签（片剂、口服溶液与包装面板；SPL v42）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=046e61c9-9298-4b2e-b76e-b26b81fecd20", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "productRoutes": [ { "source": { "id": "src_71117a23bfe61907", "label": "DailyMed（NLM）：BARACLUDE 有日期美国公开标签（片剂、口服溶液与包装面板；SPL v42）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=046e61c9-9298-4b2e-b76e-b26b81fecd20", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_bb8e05e50e2f7f61", "label": "FDA：BARACLUDE 2018 美国标签", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021798s021lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "DailyMed 的 BARACLUDE（entecavir）有日期美国公开标签列出 0.5 mg 片、1 mg 片和 0.05 mg/mL 即用型口服溶液，并提供三张分别对应的包装展示面。本页把三者分开核对；不把 mg、mg/mL、片数、瓶装毫升数或相同通用名转换为任何人的服用量、剂型替换、停药或购买决定。该资料正文版本为 2019 年，不代表当前供应。", "history": "中文检索线索“博路定”、英文品牌 BARACLUDE、通用名恩替卡韦、NDC、片剂或口服溶液、每单位标示强度和目标市场需要同时核对。相同通用名、相近包装或相同数字不能替代准确产品、目标市场现行标签和专业复核。", "sourceDocuments": [ { "id": "src_bb8e05e50e2f7f61", "label": "FDA：BARACLUDE 2018 美国标签", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021798s021lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_71117a23bfe61907", "label": "DailyMed（NLM）：BARACLUDE 有日期美国公开标签（片剂、口服溶液与包装面板；SPL v42）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=046e61c9-9298-4b2e-b76e-b26b81fecd20", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_5ed30b676fbb9773", "label": "FDA Drugs@FDA 官方检索入口", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_lookup_entry", "documentKind": "regulatory_lookup", "market": "US", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } ], "applicationNumber": "NDA 021797 / 021798（以具体 FDA 文件核对）", "approvalTimeline": [ { "date": "2005", "title": { "zh": "美国公开历史资料入口", "en": "U.S. public historical-material entry point" }, "detail": { "zh": "本档案以 Baraclude® 的 FDA 公开资料为历史阅读入口；批准编号和具体产品文件须回到对应数据库页面逐项核验。", "en": "This archive uses FDA public material for Baraclude® as a historical reading entry point; approval number and specific product document must be checked record by record in the database." }, "source": { "id": "src_5ed30b676fbb9773", "label": "FDA Drugs@FDA search", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_lookup_entry", "documentKind": "regulatory_lookup", "market": "US", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, { "date": "2018-06", "title": { "zh": "FDA 标签档案版本", "en": "FDA label archive version" }, "detail": { "zh": "本页链接 2018-06 FDA 标签档案；任何现行信息均应由目标市场当前文件复核。", "en": "This page links the Jun 2018 FDA label archive; all current information needs review against the target market’s current record." }, "source": { "id": "src_bb8e05e50e2f7f61", "label": "FDA: Baraclude prescribing information", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021798s021lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, { "date": "2019-11", "title": { "zh": "DailyMed SPL v42 有日期标签版本", "en": "DailyMed SPL v42 dated label version" }, "detail": { "zh": "DailyMed 的 BARACLUDE SPL v42 标示 2019-11-06 生效，并在媒体目录中列为 2025-12-22 发布。它支持本页三个精确包装展示面；不代表当前供应或其他市场状态。", "en": "BARACLUDE DailyMed SPL v42 is marked effective 6 Nov 2019 and listed in the media directory as published 22 Dec 2025. It supports this page's three exact package panels; it does not establish current supply or another-market status." }, "source": { "id": "src_71117a23bfe61907", "label": "DailyMed（NLM）：BARACLUDE 有日期美国公开标签（片剂、口服溶液与包装面板；SPL v42）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=046e61c9-9298-4b2e-b76e-b26b81fecd20", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "已链接公开标签档案", "en": "Public label archive linked" }, "detail": { "zh": "本页仅建立文件阅读路径。", "en": "This page establishes only a document-reading path." } }, { "market": { "zh": "中国大陆、欧盟、日本", "en": "Mainland China, EU, Japan" }, "status": { "zh": "待逐项建立市场记录", "en": "Market record not established" }, "detail": { "zh": "不从美国标签档案推定当地产品状态。", "en": "No local product status is inferred from the U.S. label archive." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "历史标签能用于决定实际用药吗？", "en": "Can a historical label decide actual use?" }, "answer": { "zh": "不能。历史文件用于理解资料来源；个体用药和现行风险信息必须依据目标市场的最新标签并咨询专业人员。", "en": "No. Historical material is for understanding sources; individual use and current safety information require the latest target-market label and professional advice." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "how-to-read-a-drug-label", "regulatory-sources-first" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/entecavir-baraclude/", "en": "https://origindrug.com/en/drugs/entecavir-baraclude/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "amoxicillin-amoxil", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-09-02", "status": "published_traceable_archive" }, "names": { "brand": "Amoxil", "generic": "阿莫西林", "aliases": [ "amoxicillin", "阿莫西林片", "阿莫西林胶囊", "阿莫西林胶囊 500 mg", "阿莫西林咀嚼片", "阿莫西林口服混悬液", "阿莫仙" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": { "value": "阿莫仙®", "status": "discovery_cue_requires_target_market_verification", "source": null } }, "identity": { "therapeuticArea": "感染", "sourceArchiveMarket": "美国 AMOXIL 四个 NDA 品牌档案；另列现行阿莫西林 ANDA 标签作为不同产品证据", "dosageFormClass": "AMOXIL 片 500/875 mg；复溶后混悬液 200/400 mg 每 5 mL；咀嚼片 125/200/250/400 mg", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "1974", "archiveSponsorText": "USAntibiotics LLC（FDA AMOXIL NDA 档案申请方；标签注明 GSK 商标许可）" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [ "Amoxil", "amoxicillin", "阿莫西林", "阿莫仙", "阿莫西林片", "阿莫西林胶囊", "阿莫西林咀嚼片", "阿莫西林口服混悬液", "AMOXIL 875 mg tablet", "阿莫西林 400 mg/5 mL 口服混悬液", "阿莫西林胶囊 500 mg" ], "excludedProductCues": [ "AUGMENTIN", "amoxicillin clavulanate", "阿莫西林克拉维酸" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-amoxil-nda-050754-tablet-500mg", "marketCode": "US", "labelVersion": { "zh": "FDA AMOXIL 品牌标签（2024-05 修订）· NDA 050754 · Orange Book DISCN · RLD", "en": "FDA AMOXIL brand label (revised May 2024) · NDA 050754 · Orange Book DISCN · RLD" }, "dosageForm": { "zh": "AMOXIL 阿莫西林薄膜衣口服片", "en": "AMOXIL amoxicillin film-coated oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 81964-024-01 / 81964-024-05 / 81964-024-14", "pouchCode": null, "applicationNumber": "NDA 050754", "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "500 mg；100 片瓶、500 片瓶或 20 片包装", "en": "500 mg; 100-tablet bottle, 500-tablet bottle or 20-tablet pack" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "阿莫西林", "en": "amoxicillin" }, "value": 500, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、掰片或换算指令", "en": "labelled amount per tablet; not an individual's tablet count, splitting or conversion instruction" } } ], "concentration": null, "container": { "typeCode": "bottle_or_unit_dose", "typeLabel": { "zh": "100 片瓶、500 片瓶或 20 片包装", "en": "100-tablet bottle, 500-tablet bottle or 20-tablet pack" }, "fill": null, "countPerPackage": null, "countUnit": null }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-30", "currentLabelDisplayed": false, "ndcDirectoryListed": false, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": null, "physicalClues": { "color": { "zh": "粉红色", "en": "pink" }, "shape": { "zh": "胶囊形薄膜衣片", "en": "capsule-shaped film-coated tablet" }, "imprint": "AMOXIL / 500", "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_681f4705630060f9", "label": "FDA：AMOXIL 阿莫西林品牌处方信息（四个 NDA；2024-05 修订）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/050542s032lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-amoxil-nda-050754-tablet-875mg", "marketCode": "US", "labelVersion": { "zh": "FDA AMOXIL 品牌标签（2024-05 修订）· NDA 050754 · Orange Book DISCN · RLD", "en": "FDA AMOXIL brand label (revised May 2024) · NDA 050754 · Orange Book DISCN · RLD" }, "dosageForm": { "zh": "AMOXIL 阿莫西林薄膜衣口服片", "en": "AMOXIL amoxicillin film-coated oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 81964-019-01 / 81964-019-14", "pouchCode": null, "applicationNumber": "NDA 050754", "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "875 mg；100 片瓶或 20 片包装", "en": "875 mg; 100-tablet bottle or 20-tablet pack" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "阿莫西林", "en": "amoxicillin" }, "value": 875, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、掰片或换算指令", "en": "labelled amount per tablet; not an individual's tablet count, splitting or conversion instruction" } } ], "concentration": null, "container": { "typeCode": "bottle_or_unit_dose", "typeLabel": { "zh": "100 片瓶或 20 片包装", "en": "100-tablet bottle or 20-tablet pack" }, "fill": null, "countPerPackage": null, "countUnit": null }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-30", "currentLabelDisplayed": false, "ndcDirectoryListed": false, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": null, "physicalClues": { "color": { "zh": "粉红色", "en": "pink" }, "shape": { "zh": "胶囊形薄膜衣片；有刻痕，但刻痕不是自行掰片许可", "en": "capsule-shaped film-coated tablet; scored, but the score is not self-splitting permission" }, "imprint": "AMOXIL / 875", "scoreStatus": "scored_status_not_a_split_instruction", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_681f4705630060f9", "label": "FDA：AMOXIL 阿莫西林品牌处方信息（四个 NDA；2024-05 修订）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/050542s032lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-amoxil-nda-050760-suspension-200mg-per-5ml", "marketCode": "US", "labelVersion": { "zh": "FDA AMOXIL 品牌标签（2024-05 修订）· NDA 050760 · Orange Book DISCN · RLD", "en": "FDA AMOXIL brand label (revised May 2024) · NDA 050760 · Orange Book DISCN · RLD" }, "dosageForm": { "zh": "AMOXIL 阿莫西林复溶后口服混悬液", "en": "AMOXIL amoxicillin oral suspension after reconstitution" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 81964-023-50 / 81964-023-51 / 81964-023-52", "pouchCode": null, "applicationNumber": "NDA 050760", "presentationRole": null, "primaryStrengthBasisCode": "per_5_mL", "primaryDisplay": { "zh": "200 mg/5 mL；复溶后 50、75 或 100 mL 瓶", "en": "200 mg/5 mL; 50, 75 or 100 mL bottle after reconstitution" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "阿莫西林", "en": "amoxicillin" }, "value": 200, "unit": "mg", "basisCode": "per_5_mL", "basisLabel": { "zh": "复溶后每 5 mL 标签标示量；不是个人毫升数、配制或量取指令", "en": "labelled amount per 5 mL after reconstitution; not an individual's millilitre amount, preparation or measuring instruction" } } ], "concentration": null, "container": { "typeCode": "bottle_for_reconstitution", "typeLabel": { "zh": "复溶后 50、75 或 100 mL 瓶", "en": "50, 75 or 100 mL bottle after reconstitution" }, "fill": null, "countPerPackage": null, "countUnit": null }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-30", "currentLabelDisplayed": false, "ndcDirectoryListed": false, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": null, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_681f4705630060f9", "label": "FDA：AMOXIL 阿莫西林品牌处方信息（四个 NDA；2024-05 修订）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/050542s032lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-amoxil-nda-050760-suspension-400mg-per-5ml", "marketCode": "US", "labelVersion": { "zh": "FDA AMOXIL 品牌标签（2024-05 修订）· NDA 050760 · Orange Book RX · RLD · AB", "en": "FDA AMOXIL brand label (revised May 2024) · NDA 050760 · Orange Book RX · RLD · AB" }, "dosageForm": { "zh": "AMOXIL 阿莫西林复溶后口服混悬液", "en": "AMOXIL amoxicillin oral suspension after reconstitution" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 81964-007-50 / 81964-007-51 / 81964-007-52", "pouchCode": null, "applicationNumber": "NDA 050760", "presentationRole": null, "primaryStrengthBasisCode": "per_5_mL", "primaryDisplay": { "zh": "400 mg/5 mL；复溶后 50、75 或 100 mL 瓶", "en": "400 mg/5 mL; 50, 75 or 100 mL bottle after reconstitution" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "阿莫西林", "en": "amoxicillin" }, "value": 400, "unit": "mg", "basisCode": "per_5_mL", "basisLabel": { "zh": "复溶后每 5 mL 标签标示量；不是个人毫升数、配制或量取指令", "en": "labelled amount per 5 mL after reconstitution; not an individual's millilitre amount, preparation or measuring instruction" } } ], "concentration": null, "container": { "typeCode": "bottle_for_reconstitution", "typeLabel": { "zh": "复溶后 50、75 或 100 mL 瓶", "en": "50, 75 or 100 mL bottle after reconstitution" }, "fill": null, "countPerPackage": null, "countUnit": null }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-30", "currentLabelDisplayed": false, "ndcDirectoryListed": false, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": null, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_681f4705630060f9", "label": "FDA：AMOXIL 阿莫西林品牌处方信息（四个 NDA；2024-05 修订）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/050542s032lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-amoxil-nda-050542-chewable-125mg", "marketCode": "US", "labelVersion": { "zh": "FDA AMOXIL 品牌标签（2024-05 修订）· NDA 050542 · Orange Book DISCN · RLD", "en": "FDA AMOXIL brand label (revised May 2024) · NDA 050542 · Orange Book DISCN · RLD" }, "dosageForm": { "zh": "AMOXIL 阿莫西林咀嚼片", "en": "AMOXIL amoxicillin chewable tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 81964-026-60 / 81964-026-01", "pouchCode": null, "applicationNumber": "NDA 050542", "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "125 mg；60 或 100 片瓶", "en": "125 mg; 60- or 100-tablet bottle" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "阿莫西林", "en": "amoxicillin" }, "value": 125, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、掰片或换算指令", "en": "labelled amount per tablet; not an individual's tablet count, splitting or conversion instruction" } } ], "concentration": null, "container": { "typeCode": "bottle_or_unit_dose", "typeLabel": { "zh": "60 或 100 片瓶", "en": "60- or 100-tablet bottle" }, "fill": null, "countPerPackage": null, "countUnit": null }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-30", "currentLabelDisplayed": false, "ndcDirectoryListed": false, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": null, "physicalClues": { "color": { "zh": "淡粉红色", "en": "pale pink" }, "shape": { "zh": "圆形咀嚼片", "en": "round chewable tablet" }, "imprint": "AMOXIL / 125", "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_681f4705630060f9", "label": "FDA：AMOXIL 阿莫西林品牌处方信息（四个 NDA；2024-05 修订）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/050542s032lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-amoxil-nda-050761-chewable-200mg", "marketCode": "US", "labelVersion": { "zh": "FDA AMOXIL 品牌标签（2024-05 修订）· NDA 050761 · Orange Book DISCN", "en": "FDA AMOXIL brand label (revised May 2024) · NDA 050761 · Orange Book DISCN" }, "dosageForm": { "zh": "AMOXIL 阿莫西林咀嚼片", "en": "AMOXIL amoxicillin chewable tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 81964-028-14", "pouchCode": null, "applicationNumber": "NDA 050761", "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "200 mg；20 片单剂量包装", "en": "200 mg; 20-tablet unit-dose pack" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "阿莫西林", "en": "amoxicillin" }, "value": 200, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、掰片或换算指令", "en": "labelled amount per tablet; not an individual's tablet count, splitting or conversion instruction" } } ], "concentration": null, "container": { "typeCode": "bottle_or_unit_dose", "typeLabel": { "zh": "20 片单剂量包装", "en": "20-tablet unit-dose pack" }, "fill": null, "countPerPackage": null, "countUnit": null }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-30", "currentLabelDisplayed": false, "ndcDirectoryListed": false, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": null, "physicalClues": { "color": { "zh": "淡粉红色", "en": "pale pink" }, "shape": { "zh": "圆形咀嚼片；含阿斯巴甜，苯丙酮尿症患者须核对标签", "en": "round chewable tablet; contains aspartame, so people with phenylketonuria need exact-label review" }, "imprint": "AMOXIL / 200", "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_681f4705630060f9", "label": "FDA：AMOXIL 阿莫西林品牌处方信息（四个 NDA；2024-05 修订）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/050542s032lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-amoxil-nda-050542-chewable-250mg", "marketCode": "US", "labelVersion": { "zh": "FDA AMOXIL 品牌标签（2024-05 修订）· NDA 050542 · Orange Book DISCN · RLD", "en": "FDA AMOXIL brand label (revised May 2024) · NDA 050542 · Orange Book DISCN · RLD" }, "dosageForm": { "zh": "AMOXIL 阿莫西林咀嚼片", "en": "AMOXIL amoxicillin chewable tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 81964-027-30 / 81964-027-01", "pouchCode": null, "applicationNumber": "NDA 050542", "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "250 mg；30 或 100 片瓶", "en": "250 mg; 30- or 100-tablet bottle" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "阿莫西林", "en": "amoxicillin" }, "value": 250, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、掰片或换算指令", "en": "labelled amount per tablet; not an individual's tablet count, splitting or conversion instruction" } } ], "concentration": null, "container": { "typeCode": "bottle_or_unit_dose", "typeLabel": { "zh": "30 或 100 片瓶", "en": "30- or 100-tablet bottle" }, "fill": null, "countPerPackage": null, "countUnit": null }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-30", "currentLabelDisplayed": false, "ndcDirectoryListed": false, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": null, "physicalClues": { "color": { "zh": "淡粉红色", "en": "pale pink" }, "shape": { "zh": "圆形咀嚼片", "en": "round chewable tablet" }, "imprint": "AMOXIL / 250", "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_681f4705630060f9", "label": "FDA：AMOXIL 阿莫西林品牌处方信息（四个 NDA；2024-05 修订）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/050542s032lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-amoxil-nda-050761-chewable-400mg", "marketCode": "US", "labelVersion": { "zh": "FDA AMOXIL 品牌标签（2024-05 修订）· NDA 050761 · Orange Book DISCN", "en": "FDA AMOXIL brand label (revised May 2024) · NDA 050761 · Orange Book DISCN" }, "dosageForm": { "zh": "AMOXIL 阿莫西林咀嚼片", "en": "AMOXIL amoxicillin chewable tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 81964-029-14 / 81964-029-01", "pouchCode": null, "applicationNumber": "NDA 050761", "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "400 mg；20 片单剂量包装或 100 片瓶", "en": "400 mg; 20-tablet unit-dose pack or 100-tablet bottle" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "阿莫西林", "en": "amoxicillin" }, "value": 400, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、掰片或换算指令", "en": "labelled amount per tablet; not an individual's tablet count, splitting or conversion instruction" } } ], "concentration": null, "container": { "typeCode": "bottle_or_unit_dose", "typeLabel": { "zh": "20 片单剂量包装或 100 片瓶", "en": "20-tablet unit-dose pack or 100-tablet bottle" }, "fill": null, "countPerPackage": null, "countUnit": null }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-30", "currentLabelDisplayed": false, "ndcDirectoryListed": false, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": null, "physicalClues": { "color": { "zh": "淡粉红色", "en": "pale pink" }, "shape": { "zh": "胶囊形咀嚼片；含阿斯巴甜，苯丙酮尿症患者须核对标签", "en": "capsule-shaped chewable tablet; contains aspartame, so people with phenylketonuria need exact-label review" }, "imprint": "AMOXIL / 400", "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_681f4705630060f9", "label": "FDA：AMOXIL 阿莫西林品牌处方信息（四个 NDA；2024-05 修订）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/050542s032lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [ { "id": "us-amoxicillin-anda-062216-capsule-250mg-100-count-ndc-8196422501", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前 AMOXICILLIN ANDA 062216 公开标签；2026-09-02 复核", "en": "Current DailyMed AMOXICILLIN ANDA 062216 public label; reviewed 2 Sep 2026" }, "dosageForm": { "zh": "AMOXICILLIN 阿莫西林口服胶囊（独立 ANDA 产品）", "en": "AMOXICILLIN amoxicillin oral capsule (separate ANDA product)" }, "route": { "zh": "口服（标签产品身份字段）", "en": "oral (label product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 81964-225-01", "pouchCode": null, "applicationNumber": "ANDA 062216", "presentationRole": "separate_current_anda_comparator_not_amoxil_nda_brand_pack", "primaryStrengthBasisCode": "per_capsule", "primaryDisplay": { "zh": "每粒阿莫西林 250 mg；100 粒瓶装", "en": "Amoxicillin 250 mg per capsule; 100-capsule bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=label-250mg-100s.jpg&setid=110ba6b1-f175-48a1-8e30-616c02212538", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "阿莫西林", "en": "amoxicillin" }, "value": 250, "unit": "mg", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒标签标示量；不是个人粒数、频率、疗程或剂型转换指令", "en": "labelled amount per capsule; not an individual's capsule count, frequency, course or dosage-form conversion instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 1, "countUnit": { "zh": "瓶/包", "en": "bottle per pack" }, "unitsPerContainer": { "count": 100, "unit": { "zh": "粒/瓶", "en": "capsules per bottle" } } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-02", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "physicalClues": { "color": { "zh": "粉红色与宝蓝色", "en": "pink and royal blue" }, "shape": { "zh": "胶囊；无刻痕", "en": "capsule; unscored" }, "imprint": "AMOXIL / 250", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": { "zh": "这是美国 ANDA 062216 当前公开标签中的精确包装图。胶囊虽印有 AMOXIL 字样，但本卡不是 AMOXIL NDA 品牌包装、原研身份、其他市场产品、真伪鉴定或当前有货证明。", "en": "This is an exact package panel in the current U.S. ANDA 062216 public label. Although the capsule bears an AMOXIL imprint, this card is not an AMOXIL NDA brand pack, originator-status, another-market product, authentication or current-availability claim." }, "source": { "id": "src_24ffced7f14f3b2b", "label": "DailyMed（NLM）：AMOXICILLIN 胶囊当前美国 ANDA 062216 公开标签（USAntibiotics）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=110ba6b1-f175-48a1-8e30-616c02212538", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-amoxicillin-anda-062216-capsule-250mg-500-count-ndc-8196422505", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前 AMOXICILLIN ANDA 062216 公开标签；2026-09-02 复核", "en": "Current DailyMed AMOXICILLIN ANDA 062216 public label; reviewed 2 Sep 2026" }, "dosageForm": { "zh": "AMOXICILLIN 阿莫西林口服胶囊（独立 ANDA 产品）", "en": "AMOXICILLIN amoxicillin oral capsule (separate ANDA product)" }, "route": { "zh": "口服（标签产品身份字段）", "en": "oral (label product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 81964-225-05", "pouchCode": null, "applicationNumber": "ANDA 062216", "presentationRole": "separate_current_anda_comparator_not_amoxil_nda_brand_pack", "primaryStrengthBasisCode": "per_capsule", "primaryDisplay": { "zh": "每粒阿莫西林 250 mg；500 粒瓶装", "en": "Amoxicillin 250 mg per capsule; 500-capsule bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=label-250mg-500s.jpg&setid=110ba6b1-f175-48a1-8e30-616c02212538", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "阿莫西林", "en": "amoxicillin" }, "value": 250, "unit": "mg", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒标签标示量；不是个人粒数、频率、疗程或剂型转换指令", "en": "labelled amount per capsule; not an individual's capsule count, frequency, course or dosage-form conversion instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 1, "countUnit": { "zh": "瓶/包", "en": "bottle per pack" }, "unitsPerContainer": { "count": 500, "unit": { "zh": "粒/瓶", "en": "capsules per bottle" } } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-02", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 500, "unit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "physicalClues": { "color": { "zh": "粉红色与宝蓝色", "en": "pink and royal blue" }, "shape": { "zh": "胶囊；无刻痕", "en": "capsule; unscored" }, "imprint": "AMOXIL / 250", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": { "zh": "这是美国 ANDA 062216 当前公开标签中的精确包装图。胶囊虽印有 AMOXIL 字样，但本卡不是 AMOXIL NDA 品牌包装、原研身份、其他市场产品、真伪鉴定或当前有货证明。", "en": "This is an exact package panel in the current U.S. ANDA 062216 public label. Although the capsule bears an AMOXIL imprint, this card is not an AMOXIL NDA brand pack, originator-status, another-market product, authentication or current-availability claim." }, "source": { "id": "src_24ffced7f14f3b2b", "label": "DailyMed（NLM）：AMOXICILLIN 胶囊当前美国 ANDA 062216 公开标签（USAntibiotics）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=110ba6b1-f175-48a1-8e30-616c02212538", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-amoxicillin-anda-062216-capsule-500mg-100-count-ndc-8196420501", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前 AMOXICILLIN ANDA 062216 公开标签；2026-09-02 复核", "en": "Current DailyMed AMOXICILLIN ANDA 062216 public label; reviewed 2 Sep 2026" }, "dosageForm": { "zh": "AMOXICILLIN 阿莫西林口服胶囊（独立 ANDA 产品）", "en": "AMOXICILLIN amoxicillin oral capsule (separate ANDA product)" }, "route": { "zh": "口服（标签产品身份字段）", "en": "oral (label product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 81964-205-01", "pouchCode": null, "applicationNumber": "ANDA 062216", "presentationRole": "separate_current_anda_comparator_not_amoxil_nda_brand_pack", "primaryStrengthBasisCode": "per_capsule", "primaryDisplay": { "zh": "每粒阿莫西林 500 mg；100 粒瓶装", "en": "Amoxicillin 500 mg per capsule; 100-capsule bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=label-500mg-100s.jpg&setid=110ba6b1-f175-48a1-8e30-616c02212538", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "阿莫西林", "en": "amoxicillin" }, "value": 500, "unit": "mg", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒标签标示量；不是个人粒数、频率、疗程或剂型转换指令", "en": "labelled amount per capsule; not an individual's capsule count, frequency, course or dosage-form conversion instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 1, "countUnit": { "zh": "瓶/包", "en": "bottle per pack" }, "unitsPerContainer": { "count": 100, "unit": { "zh": "粒/瓶", "en": "capsules per bottle" } } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-02", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "physicalClues": { "color": { "zh": "粉红色与宝蓝色", "en": "pink and royal blue" }, "shape": { "zh": "胶囊；无刻痕", "en": "capsule; unscored" }, "imprint": "AMOXIL / 500", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": { "zh": "这是美国 ANDA 062216 当前公开标签中的精确包装图。胶囊虽印有 AMOXIL 字样，但本卡不是 AMOXIL NDA 品牌包装、原研身份、其他市场产品、真伪鉴定或当前有货证明。", "en": "This is an exact package panel in the current U.S. ANDA 062216 public label. Although the capsule bears an AMOXIL imprint, this card is not an AMOXIL NDA brand pack, originator-status, another-market product, authentication or current-availability claim." }, "source": { "id": "src_24ffced7f14f3b2b", "label": "DailyMed（NLM）：AMOXICILLIN 胶囊当前美国 ANDA 062216 公开标签（USAntibiotics）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=110ba6b1-f175-48a1-8e30-616c02212538", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-amoxicillin-anda-062216-capsule-500mg-500-count-ndc-8196420505", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前 AMOXICILLIN ANDA 062216 公开标签；2026-09-02 复核", "en": "Current DailyMed AMOXICILLIN ANDA 062216 public label; reviewed 2 Sep 2026" }, "dosageForm": { "zh": "AMOXICILLIN 阿莫西林口服胶囊（独立 ANDA 产品）", "en": "AMOXICILLIN amoxicillin oral capsule (separate ANDA product)" }, "route": { "zh": "口服（标签产品身份字段）", "en": "oral (label product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 81964-205-05", "pouchCode": null, "applicationNumber": "ANDA 062216", "presentationRole": "separate_current_anda_comparator_not_amoxil_nda_brand_pack", "primaryStrengthBasisCode": "per_capsule", "primaryDisplay": { "zh": "每粒阿莫西林 500 mg；500 粒瓶装", "en": "Amoxicillin 500 mg per capsule; 500-capsule bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=label-500mg-500s.jpg&setid=110ba6b1-f175-48a1-8e30-616c02212538", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "阿莫西林", "en": "amoxicillin" }, "value": 500, "unit": "mg", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒标签标示量；不是个人粒数、频率、疗程或剂型转换指令", "en": "labelled amount per capsule; not an individual's capsule count, frequency, course or dosage-form conversion instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 1, "countUnit": { "zh": "瓶/包", "en": "bottle per pack" }, "unitsPerContainer": { "count": 500, "unit": { "zh": "粒/瓶", "en": "capsules per bottle" } } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-02", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 500, "unit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "physicalClues": { "color": { "zh": "粉红色与宝蓝色", "en": "pink and royal blue" }, "shape": { "zh": "胶囊；无刻痕", "en": "capsule; unscored" }, "imprint": "AMOXIL / 500", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": { "zh": "这是美国 ANDA 062216 当前公开标签中的精确包装图。胶囊虽印有 AMOXIL 字样，但本卡不是 AMOXIL NDA 品牌包装、原研身份、其他市场产品、真伪鉴定或当前有货证明。", "en": "This is an exact package panel in the current U.S. ANDA 062216 public label. Although the capsule bears an AMOXIL imprint, this card is not an AMOXIL NDA brand pack, originator-status, another-market product, authentication or current-availability claim." }, "source": { "id": "src_24ffced7f14f3b2b", "label": "DailyMed（NLM）：AMOXICILLIN 胶囊当前美国 ANDA 062216 公开标签（USAntibiotics）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=110ba6b1-f175-48a1-8e30-616c02212538", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-amoxicillin-anda-062216-capsule-500mg-100-count-ndc-8196420510", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前 AMOXICILLIN ANDA 062216 公开标签；2026-09-02 复核", "en": "Current DailyMed AMOXICILLIN ANDA 062216 public label; reviewed 2 Sep 2026" }, "dosageForm": { "zh": "AMOXICILLIN 阿莫西林口服胶囊（独立 ANDA 产品）", "en": "AMOXICILLIN amoxicillin oral capsule (separate ANDA product)" }, "route": { "zh": "口服（标签产品身份字段）", "en": "oral (label product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 81964-205-10", "pouchCode": null, "applicationNumber": "ANDA 062216", "presentationRole": "separate_current_anda_comparator_not_amoxil_nda_brand_pack", "primaryStrengthBasisCode": "per_capsule", "primaryDisplay": { "zh": "每粒阿莫西林 500 mg；100 粒瓶装（防儿童开启瓶盖）", "en": "Amoxicillin 500 mg per capsule; 100-capsule bottle with child-resistant closure" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=label-500mg-100cr.jpg&setid=110ba6b1-f175-48a1-8e30-616c02212538", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "阿莫西林", "en": "amoxicillin" }, "value": 500, "unit": "mg", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒标签标示量；不是个人粒数、频率、疗程或剂型转换指令", "en": "labelled amount per capsule; not an individual's capsule count, frequency, course or dosage-form conversion instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "防儿童开启瓶装", "en": "bottle with child-resistant closure" }, "fill": null, "countPerPackage": 1, "countUnit": { "zh": "瓶/包", "en": "bottle per pack" }, "unitsPerContainer": { "count": 100, "unit": { "zh": "粒/瓶", "en": "capsules per bottle" } } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-02", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "physicalClues": { "color": { "zh": "粉红色与宝蓝色", "en": "pink and royal blue" }, "shape": { "zh": "胶囊；无刻痕", "en": "capsule; unscored" }, "imprint": "AMOXIL / 500", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": { "zh": "这是美国 ANDA 062216 当前公开标签中的精确包装图。胶囊虽印有 AMOXIL 字样，但本卡不是 AMOXIL NDA 品牌包装、原研身份、其他市场产品、真伪鉴定或当前有货证明。", "en": "This is an exact package panel in the current U.S. ANDA 062216 public label. Although the capsule bears an AMOXIL imprint, this card is not an AMOXIL NDA brand pack, originator-status, another-market product, authentication or current-availability claim." }, "source": { "id": "src_24ffced7f14f3b2b", "label": "DailyMed（NLM）：AMOXICILLIN 胶囊当前美国 ANDA 062216 公开标签（USAntibiotics）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=110ba6b1-f175-48a1-8e30-616c02212538", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-amoxicillin-anda-062216-capsule-500mg-60-count-ndc-8196420560", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前 AMOXICILLIN ANDA 062216 公开标签；2026-09-02 复核", "en": "Current DailyMed AMOXICILLIN ANDA 062216 public label; reviewed 2 Sep 2026" }, "dosageForm": { "zh": "AMOXICILLIN 阿莫西林口服胶囊（独立 ANDA 产品）", "en": "AMOXICILLIN amoxicillin oral capsule (separate ANDA product)" }, "route": { "zh": "口服（标签产品身份字段）", "en": "oral (label product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 81964-205-60", "pouchCode": null, "applicationNumber": "ANDA 062216", "presentationRole": "separate_current_anda_comparator_not_amoxil_nda_brand_pack", "primaryStrengthBasisCode": "per_capsule", "primaryDisplay": { "zh": "每粒阿莫西林 500 mg；60 粒瓶装（防儿童开启瓶盖）", "en": "Amoxicillin 500 mg per capsule; 60-capsule bottle with child-resistant closure" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=label-500mg-60cr.jpg&setid=110ba6b1-f175-48a1-8e30-616c02212538", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "阿莫西林", "en": "amoxicillin" }, "value": 500, "unit": "mg", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒标签标示量；不是个人粒数、频率、疗程或剂型转换指令", "en": "labelled amount per capsule; not an individual's capsule count, frequency, course or dosage-form conversion instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "防儿童开启瓶装", "en": "bottle with child-resistant closure" }, "fill": null, "countPerPackage": 1, "countUnit": { "zh": "瓶/包", "en": "bottle per pack" }, "unitsPerContainer": { "count": 60, "unit": { "zh": "粒/瓶", "en": "capsules per bottle" } } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-02", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 60, "unit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "physicalClues": { "color": { "zh": "粉红色与宝蓝色", "en": "pink and royal blue" }, "shape": { "zh": "胶囊；无刻痕", "en": "capsule; unscored" }, "imprint": "AMOXIL / 500", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": { "zh": "这是美国 ANDA 062216 当前公开标签中的精确包装图。胶囊虽印有 AMOXIL 字样，但本卡不是 AMOXIL NDA 品牌包装、原研身份、其他市场产品、真伪鉴定或当前有货证明。", "en": "This is an exact package panel in the current U.S. ANDA 062216 public label. Although the capsule bears an AMOXIL imprint, this card is not an AMOXIL NDA brand pack, originator-status, another-market product, authentication or current-availability claim." }, "source": { "id": "src_24ffced7f14f3b2b", "label": "DailyMed（NLM）：AMOXICILLIN 胶囊当前美国 ANDA 062216 公开标签（USAntibiotics）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=110ba6b1-f175-48a1-8e30-616c02212538", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-amoxicillin-anda-062216-capsule-500mg-100-count-ndc-8196435010", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前 AMOXICILLIN ANDA 062216 公开标签；2026-09-02 复核", "en": "Current DailyMed AMOXICILLIN ANDA 062216 public label; reviewed 2 Sep 2026" }, "dosageForm": { "zh": "AMOXICILLIN 阿莫西林口服胶囊（独立 ANDA 产品）", "en": "AMOXICILLIN amoxicillin oral capsule (separate ANDA product)" }, "route": { "zh": "口服（标签产品身份字段）", "en": "oral (label product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 81964-350-10", "pouchCode": null, "applicationNumber": "ANDA 062216", "presentationRole": "separate_current_anda_comparator_not_amoxil_nda_brand_pack", "primaryStrengthBasisCode": "per_capsule", "primaryDisplay": { "zh": "每粒阿莫西林 500 mg；100 粒瓶装（防儿童开启瓶盖）", "en": "Amoxicillin 500 mg per capsule; 100-capsule bottle with child-resistant closure" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=label-500mg-white-100cr.jpg&setid=110ba6b1-f175-48a1-8e30-616c02212538", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "阿莫西林", "en": "amoxicillin" }, "value": 500, "unit": "mg", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒标签标示量；不是个人粒数、频率、疗程或剂型转换指令", "en": "labelled amount per capsule; not an individual's capsule count, frequency, course or dosage-form conversion instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "防儿童开启瓶装", "en": "bottle with child-resistant closure" }, "fill": null, "countPerPackage": 1, "countUnit": { "zh": "瓶/包", "en": "bottle per pack" }, "unitsPerContainer": { "count": 100, "unit": { "zh": "粒/瓶", "en": "capsules per bottle" } } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-02", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "physicalClues": { "color": { "zh": "白色", "en": "white" }, "shape": { "zh": "胶囊；无刻痕", "en": "capsule; unscored" }, "imprint": "AMOXIL / 500", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": { "zh": "这是美国 ANDA 062216 当前公开标签中的精确包装图。胶囊虽印有 AMOXIL 字样，但本卡不是 AMOXIL NDA 品牌包装、原研身份、其他市场产品、真伪鉴定或当前有货证明。", "en": "This is an exact package panel in the current U.S. ANDA 062216 public label. Although the capsule bears an AMOXIL imprint, this card is not an AMOXIL NDA brand pack, originator-status, another-market product, authentication or current-availability claim." }, "source": { "id": "src_24ffced7f14f3b2b", "label": "DailyMed（NLM）：AMOXICILLIN 胶囊当前美国 ANDA 062216 公开标签（USAntibiotics）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=110ba6b1-f175-48a1-8e30-616c02212538", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-amoxicillin-anda-062216-capsule-500mg-60-count-ndc-8196435060", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前 AMOXICILLIN ANDA 062216 公开标签；2026-09-02 复核", "en": "Current DailyMed AMOXICILLIN ANDA 062216 public label; reviewed 2 Sep 2026" }, "dosageForm": { "zh": "AMOXICILLIN 阿莫西林口服胶囊（独立 ANDA 产品）", "en": "AMOXICILLIN amoxicillin oral capsule (separate ANDA product)" }, "route": { "zh": "口服（标签产品身份字段）", "en": "oral (label product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 81964-350-60", "pouchCode": null, "applicationNumber": "ANDA 062216", "presentationRole": "separate_current_anda_comparator_not_amoxil_nda_brand_pack", "primaryStrengthBasisCode": "per_capsule", "primaryDisplay": { "zh": "每粒阿莫西林 500 mg；60 粒瓶装（防儿童开启瓶盖）", "en": "Amoxicillin 500 mg per capsule; 60-capsule bottle with child-resistant closure" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=label-500mg-white-60cr.jpg&setid=110ba6b1-f175-48a1-8e30-616c02212538", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "阿莫西林", "en": "amoxicillin" }, "value": 500, "unit": "mg", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒标签标示量；不是个人粒数、频率、疗程或剂型转换指令", "en": "labelled amount per capsule; not an individual's capsule count, frequency, course or dosage-form conversion instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "防儿童开启瓶装", "en": "bottle with child-resistant closure" }, "fill": null, "countPerPackage": 1, "countUnit": { "zh": "瓶/包", "en": "bottle per pack" }, "unitsPerContainer": { "count": 60, "unit": { "zh": "粒/瓶", "en": "capsules per bottle" } } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-02", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 60, "unit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "physicalClues": { "color": { "zh": "白色", "en": "white" }, "shape": { "zh": "胶囊；无刻痕", "en": "capsule; unscored" }, "imprint": "AMOXIL / 500", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": { "zh": "这是美国 ANDA 062216 当前公开标签中的精确包装图。胶囊虽印有 AMOXIL 字样，但本卡不是 AMOXIL NDA 品牌包装、原研身份、其他市场产品、真伪鉴定或当前有货证明。", "en": "This is an exact package panel in the current U.S. ANDA 062216 public label. Although the capsule bears an AMOXIL imprint, this card is not an AMOXIL NDA brand pack, originator-status, another-market product, authentication or current-availability claim." }, "source": { "id": "src_24ffced7f14f3b2b", "label": "DailyMed（NLM）：AMOXICILLIN 胶囊当前美国 ANDA 062216 公开标签（USAntibiotics）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=110ba6b1-f175-48a1-8e30-616c02212538", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "appearanceReferences": [], "visualReference": { "status": "withheld_repackaged_or_non_exact_visual", "title": { "zh": "已核验 AMOXIL 四个 NDA 的品牌标签，但未保留可与单一原品牌包装一一对应的官方图片，故不展示包装图", "en": "The AMOXIL brand label for four NDAs was reviewed, but no official image matching one exact original-brand pack was retained, so no package visual is shown" }, "summary": { "zh": "FDA 2024 品牌标签提供片剂、混悬液和咀嚼片的强度、NDC、包装与外观文字，但此次未保留可安全公开展示且与单一 AMOXIL NDA 包装准确对应的官方图片。先前使用的 250/500 mg 胶囊图片来自另一份 AMOXICILLIN ANDA 标签，不能再作为 AMOXIL 原品牌外观。为避免误导，页面以八张标签文字身份卡代替包装图，并保留 ANDA 对照来源供核验。", "en": "The 2024 FDA brand label provides strengths, NDCs, packaging and appearance text for tablets, suspension and chewables, but no official image was retained that can safely be displayed and matched to one exact AMOXIL NDA pack. The previously used 250/500 mg capsule images come from a different AMOXICILLIN ANDA label and cannot serve as AMOXIL original-brand appearance. To prevent confusion, the page uses eight source-text identity cards and retains the ANDA comparator source for verification." }, "source": { "id": "src_681f4705630060f9", "label": "FDA：AMOXIL 阿莫西林品牌处方信息（四个 NDA；2024-05 修订）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/050542s032lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "AMOXIL 说明书放大阅读：先分清 NDA 品牌剂型，再看另一份 ANDA 通用名标签", "en": "AMOXIL label reading: separate the NDA brand forms from a different ANDA generic label" }, "summary": { "zh": "FDA 2024 AMOXIL 品牌标签列的是 500/875 mg 片、200/400 mg 每 5 mL 复溶后混悬液和 125/200/250/400 mg 咀嚼片；当前 DailyMed 的 250/500 mg 胶囊及 125/250 mg 每 5 mL 混悬液属于另一份 AMOXICILLIN ANDA 标签，不能合并成 AMOXIL 原研包装。", "en": "The 2024 FDA AMOXIL brand label lists 500/875 mg tablets, 200/400 mg per 5 mL suspension after reconstitution, and 125/200/250/400 mg chewables. The current DailyMed 250/500 mg capsules and 125/250 mg per 5 mL suspension belong to a different AMOXICILLIN ANDA label and cannot be merged into the AMOXIL NDA brand pack." }, "checks": [ { "zh": "“500 mg/片”和“400 mg/5 mL”是两种不同剂型的标签单位。包装数字不能回答个人该吃几片或几毫升；诊断、年龄或体重、肾功能、准确产品、处方和目标市场标签缺一不可。", "en": "‘500 mg per tablet’ and ‘400 mg per 5 mL’ are label units for different forms. Pack numbers cannot answer how many tablets or millilitres an individual should take; diagnosis, age or weight, kidney function, exact product, prescription and target-market label are all required." }, { "zh": "875 mg 片有刻痕是该标签产品的外观身份，不是自行掰半、减量或替换其他规格的许可。是否能分片、怎样服用或改用混悬液，必须由准确现行标签和药师结合处方确认。", "en": "The score on the 875 mg tablet is an appearance feature of that labelled product, not permission to halve, reduce or substitute another strength. Splitting, administration or changing to suspension requires the exact current label and pharmacist review against the prescription." }, { "zh": "200 mg 与 400 mg 咀嚼片含阿斯巴甜，FDA 标签列出苯丙氨酸信息；这不是对所有人都不适用的结论，但苯丙酮尿症等情况应带准确产品向专业人员核对。", "en": "The 200 mg and 400 mg chewables contain aspartame, and the FDA label lists phenylalanine information. This does not mean they are unsuitable for everyone, but phenylketonuria and related concerns require review of the exact product with a professional." }, { "zh": "有青霉素或头孢类严重过敏史、用药后呼吸困难或广泛皮疹、严重或持续腹泻，或同时使用抗凝药、别嘌醇等药物时，应及时联系当地医生或药师；严重呼吸困难、面唇舌肿胀或晕厥应使用紧急医疗渠道。", "en": "With a serious penicillin or cephalosporin allergy history, breathing trouble or widespread rash after use, severe or persistent diarrhoea, or co-use of anticoagulants, allopurinol or other medicines, contact a local clinician or pharmacist promptly. Severe breathing difficulty, face/lip/tongue swelling or fainting requires emergency care." }, { "zh": "老年人并非按年龄自动改量；FDA 标签提示阿莫西林主要经肾脏排泄，肾功能下降时不良反应风险可能增加。请让开方团队结合肾功能和完整药单核对，不要自行减量、隔天吃或换规格。", "en": "Older age does not automatically determine an amount. The FDA label notes that amoxicillin is substantially excreted by the kidney and risk may be greater with impaired renal function. Ask the prescribing team to review kidney function and the complete medicine list; do not self-reduce, alternate days or change strength." } ], "source": { "id": "src_681f4705630060f9", "label": "FDA：AMOXIL 阿莫西林品牌处方信息（四个 NDA；2024-05 修订）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/050542s032lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "阿莫西林怎样起作用：它影响细菌在生长时构建细胞壁的过程", "en": "How amoxicillin works: it affects bacterial cell-wall building during growth" }, "summary": { "zh": "FDA 的 AMOXIL 品牌标签描述：阿莫西林通过抑制细菌细胞壁生物合成发挥杀菌作用。它解释的是对敏感细菌的作用路径；不说明个人症状一定由细菌引起，也不决定是否使用、选哪种产品、吃几片或用几毫升。", "en": "The FDA AMOXIL brand label describes amoxicillin as bactericidal through inhibition of bacterial cell-wall biosynthesis. This explains a pathway against susceptible bacteria; it does not establish that an individual's symptoms are bacterial or decide whether to use it, which product to select, how many tablets or how many millilitres." }, "checks": [ { "zh": "可把“细胞壁”理解为细菌维持结构所需的一层构件。阿莫西林的这一路径针对的是细菌；它不能被用来判断感冒、咽痛、咳嗽或其他症状是否需要抗菌药。是否需要治疗仍取决于诊断、检查和目标市场现行标签。", "en": "A “cell wall” can be read as part of the structure a bacterium needs to maintain itself. This pathway concerns bacteria; it cannot decide whether a cold, sore throat, cough or another symptom needs an antibacterial medicine. The need for treatment still depends on diagnosis, testing and the current target-market label." }, { "zh": "“对敏感微生物”是标签中的关键限定：药物机制不是对所有病原体、所有感染部位或所有人的治疗承诺。不要因为过去同类症状曾使用过阿莫西林，就保留、借用、加量、缩短或延长疗程。", "en": "“Susceptible organisms” is a key label limitation: a mechanism is not a treatment promise for every pathogen, infection site or person. Do not retain, borrow, increase, shorten or extend amoxicillin because a similar symptom was treated with it in the past." }, { "zh": "共同机制不会把 AMOXIL NDA 片剂、混悬液、咀嚼片与另一份 ANDA 胶囊标签变成同一产品，更不会形成片数、粒数或毫升数的自行换算公式。", "en": "A shared mechanism does not turn AMOXIL NDA tablets, suspension and chewables and a separate ANDA capsule label into the same product, nor does it create a self-conversion formula for tablets, capsules or millilitres." } ], "source": { "id": "src_681f4705630060f9", "label": "FDA：AMOXIL 阿莫西林品牌处方信息（Microbiology；2024-05 修订）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/050542s032lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "Amoxil", "generic": "阿莫西林", "dosageFormClass": "AMOXIL 片 500/875 mg；复溶后混悬液 200/400 mg 每 5 mL；咀嚼片 125/200/250/400 mg" }, "labelSource": { "id": "src_681f4705630060f9", "label": "FDA：AMOXIL 阿莫西林品牌处方信息（四个 NDA；2024-05 修订）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/050542s032lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "productRoutes": [ { "source": { "id": "src_681f4705630060f9", "label": "FDA：AMOXIL 阿莫西林品牌处方信息（四个 NDA；2024-05 修订）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/050542s032lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-08-30", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_21fe247eb39c0e4a", "label": "FDA：AMOXIL 四个 NDA 补充批准函（2022-06-09）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/050542Orig1s031%3B%20050754Orig1s021%3B%20050760Orig1s021%3B%20050761Orig1s018ltr.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-08-30", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_10e511bf83430e3b", "label": "FDA Orange Book 数据入口（AMOXIL NDA 产品状态复核）", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-08-29", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_24ffced7f14f3b2b", "label": "DailyMed（NLM）：另一个 AMOXICILLIN 胶囊/混悬液 ANDA 标签（不得合并为 AMOXIL NDA 产品）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=110ba6b1-f175-48a1-8e30-616c02212538", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-09-02", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-08-30", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [ { "id": "fda-faers-amoxicillin-2023-dies-label-update", "issuedAt": "2023-09-30", "status": "fda_potential_signal_label_update_listing", "title": { "zh": "FDA FAERS 记录：阿莫西林相关产品的说明书更新线索", "en": "FDA FAERS record: labelling-update information for amoxicillin-related products" }, "summary": { "zh": "FDA 的 2023 年 7–9 月潜在严重风险/新安全信息表（页面更新至 2026-03-13）列出 Amoxil 及若干含阿莫西林产品，并说明其“警告和注意事项”及“不良反应”部分已于 2024 年 5 月补入药物诱导性小肠结肠炎综合征（DIES）信息。该表是 FDA 的安全信号与标签更新记录，不用于诊断症状，也不替代手中产品、目标市场现行说明书或专业人员判断。", "en": "FDA’s July–September 2023 potential-signal/new-safety-information table, updated on 2026-03-13, lists Amoxil and several amoxicillin-containing products and states that Warnings and Precautions and Adverse Reactions were updated in May 2024 with drug-induced enterocolitis syndrome (DIES) information. This is an FDA safety-signal and labelling-update record; it does not diagnose symptoms or replace the exact product’s current target-market label and professional review." }, "source": { "id": "src_8c74002392ff8c7f", "label": "FDA：FAERS 2023 年 7–9 月潜在严重风险/新安全信息表（阿莫西林产品标签更新）", "url": "https://www.fda.gov/drugs/fda-adverse-event-monitoring-system-aems/july-september-2023-potential-signals-serious-risksnew-safety-information-identified-fda-adverse", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "本页以 FDA 2024 AMOXIL 品牌标签建立四个 NDA 的片剂、复溶后口服混悬液和咀嚼片身份；并明确把当前 DailyMed 的 AMOXICILLIN 胶囊/混悬液 ANDA 标签留在另一条证据链。共享阿莫西林成分、AMOXIL 字样或厂家，不表示产品、剂型、包装和监管路径相同，也不能据包装强度推算个人该吃几片、几粒或几毫升。", "history": "AMOXIL 的美国品牌档案涉及 NDA 050542、050754、050760 和 050761。FDA 2024 标签列出片剂、混悬液和咀嚼片；当前 DailyMed set ID 110ba6b1… 标题为 AMOXICILLIN capsule、营销类别为 ANDA，是不同的阿莫西林产品记录，不再作为 AMOXIL NDA 的包装图片或剂型证明。中国大陆检索线索“阿莫仙”仍需以当前 NMPA 批准文件独立核验。", "sourceDocuments": [ { "id": "src_681f4705630060f9", "label": "FDA：AMOXIL 阿莫西林品牌处方信息（四个 NDA；2024-05 修订）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/050542s032lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, { "id": "src_21fe247eb39c0e4a", "label": "FDA：AMOXIL 四个 NDA 补充批准函（2022-06-09）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/050542Orig1s031%3B%20050754Orig1s021%3B%20050760Orig1s021%3B%20050761Orig1s018ltr.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, { "id": "src_10e511bf83430e3b", "label": "FDA Orange Book 数据入口（AMOXIL NDA 产品状态复核）", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, { "id": "src_24ffced7f14f3b2b", "label": "DailyMed（NLM）：另一个 AMOXICILLIN 胶囊/混悬液 ANDA 标签（不得合并为 AMOXIL NDA 产品）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=110ba6b1-f175-48a1-8e30-616c02212538", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" } ], "applicationNumber": "NDA 050542 / 050754 / 050760 / 050761", "approvalTimeline": [ { "date": "1974", "title": { "zh": "美国初始批准年份", "en": "Initial U.S. approval year" }, "detail": { "zh": "FDA AMOXIL 品牌标签列示 Initial U.S. Approval: 1974；不代表其他市场或当前供应。", "en": "The FDA AMOXIL brand label lists Initial U.S. Approval: 1974; this does not establish another market or current supply." }, "source": { "id": "src_681f4705630060f9", "label": "FDA：AMOXIL 品牌处方信息", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/050542s032lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" } }, { "date": "2022-06-09", "title": { "zh": "四个 NDA 的补充批准函", "en": "Supplement approval letter for four NDAs" }, "detail": { "zh": "FDA 批准函把 NDA 050542、050754、050760、050761 与对应 AMOXIL 产品放在同一品牌监管档案中。", "en": "The FDA letter identifies NDA 050542, 050754, 050760 and 050761 with their corresponding AMOXIL products in the brand regulatory record." }, "source": { "id": "src_21fe247eb39c0e4a", "label": "FDA：AMOXIL 四个 NDA 补充批准函", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/050542Orig1s031%3B%20050754Orig1s021%3B%20050760Orig1s021%3B%20050761Orig1s018ltr.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" } }, { "date": "2024-05", "title": { "zh": "AMOXIL 品牌标签修订", "en": "AMOXIL brand label revised" }, "detail": { "zh": "FDA 品牌标签列出片剂 500/875 mg、混悬液 200/400 mg 每 5 mL、咀嚼片 125/200/250/400 mg。", "en": "The FDA brand label lists 500/875 mg tablets, 200/400 mg per 5 mL suspension, and 125/200/250/400 mg chewables." }, "source": { "id": "src_681f4705630060f9", "label": "FDA：AMOXIL 品牌处方信息", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/050542s032lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" } }, { "date": "2026-09-02", "title": { "zh": "完成 NDA/ANDA 身份拆分与包装对照复核", "en": "NDA/ANDA separation and package comparison reviewed" }, "detail": { "zh": "现行 DailyMed AMOXICILLIN 胶囊/混悬液记录被确认是独立 ANDA 标签；8 个准确瓶装面板仅在独立对照区展示，不作为 AMOXIL NDA 的包装图片、剂型或强度证明。", "en": "The current DailyMed AMOXICILLIN capsule/suspension record was confirmed as a separate ANDA label. Eight exact bottle panels are displayed only in a separate comparison section and are not used as AMOXIL NDA package, form or strength evidence." }, "source": { "id": "src_24ffced7f14f3b2b", "label": "DailyMed：独立 AMOXICILLIN ANDA 标签", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=110ba6b1-f175-48a1-8e30-616c02212538", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" } } ], "marketStatus": [ { "market": { "zh": "美国 AMOXIL NDA", "en": "U.S. AMOXIL NDA" }, "status": { "zh": "品牌标签与 Orange Book 状态已核验", "en": "Brand label and Orange Book status reviewed" }, "detail": { "zh": "当前导入的 Orange Book 快照中，多数 AMOXIL NDA 产品为 DISCN；400 mg/5 mL 混悬液列为 RX、RLD、AB。状态不等于库存或个人可获得性。", "en": "In the imported Orange Book snapshot, most AMOXIL NDA products are DISCN; the 400 mg/5 mL suspension is listed RX, RLD and AB. Status does not establish stock or individual availability." } }, { "market": { "zh": "美国独立 ANDA", "en": "Separate U.S. ANDA" }, "status": { "zh": "作为不同产品对照保留", "en": "Retained as a different-product comparator" }, "detail": { "zh": "DailyMed 当前 250/500 mg 胶囊和 125/250 mg 每 5 mL 混悬液标签不合并进 AMOXIL NDA 产品卡。", "en": "The current DailyMed 250/500 mg capsules and 125/250 mg per 5 mL suspension label is not merged into the AMOXIL NDA cards." } }, { "market": { "zh": "中国大陆", "en": "Mainland China" }, "status": { "zh": "“阿莫仙”仅为检索线索", "en": "‘阿莫仙’ is a search cue only" }, "detail": { "zh": "尚未建立可核验的当前 NMPA 品牌说明书与批准关系，不作等同、现售或原研结论。", "en": "No verified current NMPA brand label and approval relationship has been established; no equivalence, availability or originator conclusion is made." } }, { "market": { "zh": "欧盟、日本及其他市场", "en": "EU, Japan and other markets" }, "status": { "zh": "待逐项建立市场记录", "en": "Market record not established" }, "detail": { "zh": "品牌、剂型、包装和现行状态均须独立核验。", "en": "Brand, dosage form, pack and current status each require independent verification." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "“阿莫西林”或“500 mg”能唯一定位一个产品、一次用量或一天总量吗？", "en": "Does “amoxicillin” or “500 mg” uniquely identify a product, one dose or a daily total?" }, "answer": { "zh": "不能。500 mg 可能是某一片或某一粒的标签标示量，不会单独说明个人一次吃几片、一天几次或疗程多长。还要同时核对品牌、剂型、规格或浓度、给药途径、市场、标签版本和处方；同一通用名或一个毫克数字不能取代完整产品身份和专业用药安排。", "en": "No. The 500 mg figure may be the labelled amount in one tablet or capsule; by itself it does not state how many units an individual takes at one time, how often or for how long. Brand, dosage form, strength or concentration, route, market, label version and prescription must be checked together. A generic name or one milligram figure does not replace complete product identity and professional instructions." } }, { "question": { "zh": "两粒 250 mg 能直接代替一粒 500 mg，或用 500 mg 片代替 500 mg 胶囊吗？", "en": "Can two 250 mg units directly replace one 500 mg unit, or can a 500 mg tablet replace a 500 mg capsule?" }, "answer": { "zh": "不能只做算术。相同总毫克数不证明产品、剂型、辅料、服用方法、包装、监管路径和处方意图相同。本页的 AMOXIL 品牌片剂、混悬液和咀嚼片，与另一份 AMOXICILLIN ANDA 胶囊／混悬液是不同产品记录；不要自行拼粒数、换剂型或换厂家，请把实际药盒和处方交给药师或开方团队核对。", "en": "Not from arithmetic alone. An equal milligram total does not establish the same product, dosage form, excipients, administration, packaging, regulatory pathway or prescribing intent. The AMOXIL brand tablets, suspension and chewables on this page and the separate AMOXICILLIN ANDA capsule/suspension label are different product records. Do not self-combine unit counts or change form or manufacturer; take the actual pack and prescription to a pharmacist or prescriber." } }, { "question": { "zh": "阿莫西林胶囊可以打开、片剂可以掰开，或混进食物里服用吗？", "en": "Can an amoxicillin capsule be opened, a tablet split, or the medicine mixed with food?" }, "answer": { "zh": "不要从“胶囊”“片剂”或刻痕三个线索自行决定。能否打开、掰开、咀嚼、混合或改用液体，取决于准确产品和现行说明书；AMOXIL 875 mg 片的刻痕只是该产品的外观身份，不是通用的掰片许可。请让药师核对实际药盒、剂型、标签和处方目的，尤其是儿童、吞咽困难者和需要精确量取液体的人。", "en": "Do not decide from the words “capsule” or “tablet” or from a score mark. Opening, splitting, chewing, mixing or changing to a liquid depends on the exact product and current label. The score on an AMOXIL 875 mg tablet is an identity feature of that product, not universal permission to split it. Ask a pharmacist to review the actual pack, dosage form, label and prescribing purpose, especially for children, people with swallowing difficulty or anyone who needs a precisely measured liquid." } }, { "question": { "zh": "AMOXIL、AUGMENTIN、头孢类或其他抗菌药能轮换、一起吃或用剩药补上吗？", "en": "Can AMOXIL, AUGMENTIN, a cephalosporin or another antibacterial be alternated, combined or supplemented with leftovers?" }, "answer": { "zh": "不能根据名称相近、都用于感染或过去经验自行安排。AUGMENTIN 还含克拉维酸，是另一种产品；头孢类和其他抗菌药也有各自的成分、过敏、相互作用和适用边界。不要借药、合并、轮换、补服或自行延长疗程；应由医生结合诊断、必要检查、过敏史、肾功能和完整药单决定，并按当地规则处理剩余抗菌药。", "en": "Not from similar names, a shared infection context or past experience. AUGMENTIN also contains clavulanate and is a different product; cephalosporins and other antibacterials have their own ingredients, allergy, interaction and use boundaries. Do not borrow, combine, alternate, make up doses or self-extend a course. A clinician should use the diagnosis, any necessary tests, allergy history, kidney function and complete medicine list, and leftover antibacterials should be handled under local guidance." } }, { "question": { "zh": "老人、肾功能下降或同时吃很多药时，能自己减量、隔天吃或换成低规格吗？", "en": "Can an older adult, a person with reduced kidney function or someone taking many medicines self-reduce, use alternate days or change to a lower strength?" }, "answer": { "zh": "不能。年龄本身不自动给出剂量，FDA 标签同时提示阿莫西林主要经肾脏排泄，肾功能下降时不良反应风险可能增加。请携带全部药盒、处方、过敏史、近期肾功能资料和完整药单联系开方团队或药师；不要自行减量、隔天吃、换规格或突然停用。若出现呼吸困难、面唇舌肿胀、晕厥或严重意识变化，应立即使用当地急救渠道。", "en": "No. Age alone does not determine an amount, and the FDA label also notes that amoxicillin is substantially excreted by the kidney and adverse-reaction risk may be greater with impaired renal function. Take every pack, the prescription, allergy history, recent kidney-function information and the complete medicine list to the prescriber or pharmacist. Do not self-reduce, use alternate days, change strength or abruptly stop. Breathing difficulty, swelling of the face, lips or tongue, fainting or severe altered awareness requires immediate local emergency care." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "dosage-forms-are-part-of-medicine-identity", "how-to-read-a-drug-label", "medicine-label-for-everyday-questions", "family-medicine-list-for-pharmacist" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/amoxicillin-amoxil/", "en": "https://origindrug.com/en/drugs/amoxicillin-amoxil/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "clopidogrel-plavix", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-30", "status": "published_traceable_archive" }, "names": { "brand": "Plavix", "generic": "氯吡格雷", "aliases": [ "波立维", "波立维®", "硫酸氢氯吡格雷片", "Clopidogrel Bisulfate Tablets", "clopidogrel", "clopidogrel bisulfate" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": { "value": "波立维®", "status": "discovery_cue_requires_target_market_verification", "source": { "id": "src_772528a694d31352", "label": "Sanofi China：波立维产品公开页面", "url": "https://www.sanofi.cn/zh/your-health/products/plavix", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "first_party_product_page", "market": "CN", "accessStatus": "public_access_with_site_controls", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } } }, "identity": { "therapeuticArea": "心血管", "sourceArchiveMarket": "美国 DailyMed 当前公开 PLAVIX 标签（SPL v5，2025-05-30 生效）列出 75 mg 瓶装与 300 mg 泡罩板纸盒；中国大陆赛诺菲当前产品页分别列出进口与地产波立维® 75 mg 片剂，并链接 2025-05-22 进口说明书与 2025-09-01 国产说明书。三个市场/供应路径须按准确包装和说明书分别核对。", "dosageFormClass": "PLAVIX／波立维硫酸氢氯吡格雷薄膜衣口服片：美国 75 mg、300 mg；中国大陆进口与国产产品页均列示 75 mg", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "1997（美国初始批准）", "archiveSponsorText": "Sanofi-Aventis U.S. LLC（美国当前公开标签）；赛诺菲中国官方产品页及两份有日期说明书" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [ "Plavix", "PLAVIX", "波立维", "波立维®", "氯吡格雷", "硫酸氢氯吡格雷片", "PLAVIX 75 mg", "波立维 75 mg", "PLAVIX 300 mg" ], "excludedProductCues": [ "多立维", "多立维®", "CoPlavix", "氯吡格雷阿司匹林片", "clopidogrel aspirin" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-plavix-tablet-75mg-ndc-0024-1171-90", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v5，2025-06-11 发布", "en": "DailyMed SPL v5, published 11 Jun 2025" }, "dosageForm": { "zh": "PLAVIX 氯吡格雷薄膜衣口服片", "en": "PLAVIX clopidogrel film-coated oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 0024-1171-90", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片 75 mg；90 片瓶装", "en": "75 mg per tablet; 90-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=de8b0b67-eb25-4684-83b5-7ad785314227&name=de8b0b67-eb25-4684-83b5-7ad785314227-10.jpg", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "氯吡格雷", "en": "clopidogrel" }, "value": 75, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标示量；不是个人片数、停药或换药规则", "en": "labelled amount per tablet; not an individual's tablet count, interruption or switching rule" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "90 片瓶装", "en": "90-tablet bottle" }, "fill": null, "countPerPackage": 90, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-20", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 90, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "粉红色", "en": "pink" }, "shape": { "zh": "圆形、双凸薄膜衣片", "en": "round biconvex film-coated tablet" }, "imprint": "75 / 1171", "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_3e070dd8ebe91314", "label": "DailyMed（NLM）：PLAVIX 氯吡格雷当前美国公开标签（Sanofi-Aventis；2025-05-30 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=de8b0b67-eb25-4684-83b5-7ad785314227", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-plavix-tablet-300mg-ndc-0024-1332-30", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v5，2025-05-30 生效", "en": "DailyMed SPL v5, effective 30 May 2025" }, "dosageForm": { "zh": "PLAVIX 氯吡格雷薄膜衣口服片", "en": "PLAVIX clopidogrel film-coated oral tablet" }, "route": { "zh": "口服（准确产品身份字段）", "en": "oral (exact-product identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 0024-1332-30", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片 300 mg；30 片泡罩板纸盒", "en": "300 mg per tablet; 30-tablet blister-card carton" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=de8b0b67-eb25-4684-83b5-7ad785314227-11.jpg&setid=de8b0b67-eb25-4684-83b5-7ad785314227", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "氯吡格雷", "en": "clopidogrel" }, "value": 300, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是用多片 75 mg 自行拼量、负荷或换算的许可", "en": "labelled amount per tablet; not permission to assemble a loading amount or conversion from multiple 75 mg tablets" } } ], "concentration": null, "container": { "typeCode": "blister_carton", "typeLabel": { "zh": "泡罩板纸盒", "en": "blister-card carton" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "片/盒", "en": "tablets per carton" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-30", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 30, "unit": { "zh": "片/盒", "en": "tablets per carton" } }, "physicalClues": { "color": { "zh": "粉红色", "en": "pink" }, "shape": { "zh": "长椭圆形薄膜衣片", "en": "oblong film-coated tablet" }, "imprint": "300 / 1332", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_3e070dd8ebe91314", "label": "DailyMed（NLM）：PLAVIX 300 mg、NDC 0024-1332-30、30 片泡罩板纸盒美国标签面板", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=de8b0b67-eb25-4684-83b5-7ad785314227", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "cn-plavix-clopidogrel-bisulfate-tablet-75mg-domestic-h20056410", "marketCode": "CN", "labelVersion": { "zh": "赛诺菲中国国产说明书，2025-09-01 修订", "en": "Sanofi China locally produced leaflet, revised 1 Sep 2025" }, "dosageForm": { "zh": "波立维® 硫酸氢氯吡格雷薄膜衣片（国产）", "en": "PLAVIX clopidogrel bisulfate film-coated tablet (locally produced in China)" }, "route": { "zh": "口服（中国大陆说明书产品身份字段）", "en": "oral (Mainland China leaflet product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NMPA approval No. H20056410", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片氯吡格雷 75 mg；硬双铝包装 7、14、28 或 90 片/盒", "en": "Clopidogrel 75 mg per tablet; hard double-aluminium packs of 7, 14, 28 or 90 tablets per carton" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "氯吡格雷（以硫酸氢氯吡格雷提供）", "en": "clopidogrel (provided as clopidogrel bisulfate)" }, "value": 75, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片中国说明书标示量；不是个人片数、负荷、停用或换药指令", "en": "Mainland China leaflet amount per tablet; not an individual's tablet count, loading, interruption or switching instruction" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-30", "currentLabelDisplayed": true, "ndcDirectoryListed": false, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": null, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_11bf819ee616bfaa", "label": "赛诺菲中国：波立维®国产硫酸氢氯吡格雷片说明书（75 mg；H20056410；2025-09-01 修订）", "url": "https://www.sanofi.cn/assets/dot-cn/pages/docs/products/prescription-products/20250901-Plavix-tab-75mg-LMP-PI-update-chp2025-transfered.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "first_party_leaflet", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "cn-plavix-clopidogrel-bisulfate-tablet-75mg-imported-hj20171237-hj20171238", "marketCode": "CN", "labelVersion": { "zh": "赛诺菲中国进口说明书，2025-05-22 修订", "en": "Sanofi China imported-product leaflet, revised 22 May 2025" }, "dosageForm": { "zh": "波立维® PLAVIX® 硫酸氢氯吡格雷薄膜衣片（进口）", "en": "PLAVIX clopidogrel bisulfate film-coated tablet (imported into China)" }, "route": { "zh": "口服（中国大陆说明书产品身份字段）", "en": "oral (Mainland China leaflet product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NMPA approval No. HJ20171237 (small pack) / HJ20171238 (large pack)", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片氯吡格雷 75 mg；双铝泡罩包装 7、28 或 90 片/盒", "en": "Clopidogrel 75 mg per tablet; double-aluminium blister packs of 7, 28 or 90 tablets per carton" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "氯吡格雷（以硫酸氢氯吡格雷提供）", "en": "clopidogrel (provided as clopidogrel bisulfate)" }, "value": 75, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片中国说明书标示量；不是个人片数、负荷、停用或换药指令", "en": "Mainland China leaflet amount per tablet; not an individual's tablet count, loading, interruption or switching instruction" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-30", "currentLabelDisplayed": true, "ndcDirectoryListed": false, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": null, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_3401fd02b94e49fe", "label": "赛诺菲中国：波立维®进口硫酸氢氯吡格雷片说明书（75 mg；HJ20171237/HJ20171238；2025-05-22 修订）", "url": "https://www.sanofi.cn/assets/dot-cn/pages/docs/products/prescription-products/20250522-plavix-tab-75mg-LRP-PI-MAHD-variation-transferred.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "first_party_leaflet", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-plavix-tablet-75mg-ndc-0024-1171-90", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=de8b0b67-eb25-4684-83b5-7ad785314227&name=de8b0b67-eb25-4684-83b5-7ad785314227-10.jpg", "alt": "PLAVIX 氯吡格雷在美国 DailyMed Sanofi 当前公开标签中的 75 mg、NDC 0024-1171-90、90 片瓶装展示面", "archiveMarket": "美国", "labelVersion": "DailyMed SPL v5（2025-06-11 发布）", "presentation": "PLAVIX 氯吡格雷薄膜衣片：每片 75 mg，NDC 0024-1171-90，90 片瓶装展示面。", "notice": "此图只对应美国 DailyMed 当前标签中 PLAVIX、氯吡格雷 75 mg、NDC 0024-1171-90 与 90 片瓶装。它只帮助核对品牌、通用名、每片标示量、片剂、包装数量与来源；不用于鉴定真伪，也不证明 300 mg、其他包装、其他市场、当前可得性、原研身份、可替代性或任何个人的片数、联用、开始、停用、围手术期处理或换药方案。", "source": { "id": "src_3e070dd8ebe91314", "label": "DailyMed（NLM）：PLAVIX 氯吡格雷当前美国公开标签（Sanofi-Aventis；SPL v5，2025-06-11 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=de8b0b67-eb25-4684-83b5-7ad785314227", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "PLAVIX／波立维说明书放大阅读：先分市场、75/300 mg 与单方/复方", "en": "PLAVIX / 波立维 label reading: separate market, 75/300 mg and single-ingredient/combination products" }, "summary": { "zh": "美国当前 PLAVIX 标签列出 75 mg 与 300 mg 两种片剂；赛诺菲中国当前产品页把进口与地产波立维都列为 75 mg 片剂，并各有不同说明书、包装和批准文号。多立维另含阿司匹林，是单独复方产品。本模块只帮助读懂这些身份和安全边界，不生成个人片数、负荷量、停药、手术、联用、换药或基因检测方案。", "en": "The current U.S. PLAVIX label lists 75 mg and 300 mg tablets. Sanofi China's current product page lists both imported and locally produced 波立维 75 mg tablets, each with a distinct leaflet, pack description and approval number. CoPlavix / 多立维 also contains aspirin and is a separate combination product. This module explains product identity and safety boundaries; it does not generate an individual tablet count, loading amount, interruption, procedure, combination, switching or genetic-testing plan." }, "checks": [ { "zh": "先看手上药盒属于美国 PLAVIX 75 mg／300 mg、中国进口波立维 75 mg，还是中国地产波立维 75 mg。相同品牌与毫克数不能抹去批准文号、包装片数、上市许可持有人和说明书日期差异；300 mg 也不是网页允许用多片 75 mg 自行拼出的答案。", "en": "First identify whether the pack is U.S. PLAVIX 75 mg/300 mg, imported China-market 波立维 75 mg, or locally produced China-market 波立维 75 mg. A shared brand and milligram number do not erase approval-number, pack-count, holder or leaflet-date differences, and 300 mg is not webpage permission to assemble an amount from multiple 75 mg tablets." }, { "zh": "多立维®／CoPlavix 每片还含阿司匹林，属于另一份复方药档案。看到“氯吡格雷 75 mg”不能把单方波立维和氯吡格雷/阿司匹林复方视为同一种药，也不能在药单上自行叠加、替换或补用。", "en": "CoPlavix / 多立维 contains aspirin as an additional ingredient and is a separate combination product. Seeing ‘clopidogrel 75 mg’ does not make single-ingredient PLAVIX and a clopidogrel/aspirin combination the same medicine, and it does not permit self-combination, substitution or make-up use." }, { "zh": "美国和中国说明书均讨论 CYP2C19 相关代谢差异；这不是“人人都应做全基因筛查”的结论。是否需要做哪一种检测、怎样解释已有结果、是否影响选择，必须结合适应症、事件史、目标市场说明书和完整药单由负责团队判断。", "en": "The U.S. and China leaflets discuss CYP2C19-related metabolic differences. This is not a conclusion that everyone needs whole-genome screening. Whether a test is needed, which test, how an existing result should be interpreted and whether it changes a choice require the indication, event history, target-market label and complete medicine list to be assessed by the responsible team." }, { "zh": "美国当前标签明确把奥美拉唑或艾司奥美拉唑列为需要避免同用的 CYP2C19 抑制剂线索，并指出间隔 12 小时也不能消除所观察到的影响。看到这条信息应带上胃药和完整药单请药师或开方团队处理，不能自行突然停胃药、停波立维、改时间或换成另一种药。", "en": "The current U.S. label explicitly identifies omeprazole or esomeprazole as CYP2C19-inhibitor co-medication cues to avoid and notes that separating administration by 12 hours did not remove the observed effect. This should prompt review of the stomach medicine and full list by a pharmacist or prescriber, not abrupt self-stopping, timing changes or substitution of either medicine." }, { "zh": "与阿司匹林、华法林或其他抗凝/抗血小板药、布洛芬/萘普生等 NSAID 止痛药、SSRI/SNRI 抗抑郁药同在药单时，标签提示出血风险需要优先核对。黑便、呕血、持续难止的出血，或跌倒/头部受伤后出现不适，应使用当地紧急医疗渠道；不要等待网页判断。", "en": "When aspirin, warfarin or another anticoagulant/antiplatelet medicine, an NSAID pain medicine such as ibuprofen/naproxen, or an SSRI/SNRI is on the same list, the label identifies bleeding risk for priority review. Black stool, vomiting blood, bleeding that will not stop, or symptoms after a fall/head injury require local urgent care; do not wait for a webpage to decide." }, { "zh": "准备手术、拔牙或其他侵入性操作时，不要自己照搬说明书里的天数停药。PLAVIX 标签同时警示停用会增加心血管事件风险；是否暂停、何时暂停和何时恢复必须由开方与操作团队给出针对个人和具体操作的指示。", "en": "Before surgery, dental extraction or another invasive procedure, do not copy a number of interruption days from the label yourself. The PLAVIX label also warns that discontinuation increases cardiovascular-event risk; whether to interrupt, when to do so and when to resume require instructions for the individual and specific procedure from the prescribing and procedural teams." } ], "source": { "id": "src_3e070dd8ebe91314", "label": "DailyMed（NLM）：PLAVIX 氯吡格雷当前美国公开标签（Sanofi-Aventis；2025-05-30 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=de8b0b67-eb25-4684-83b5-7ad785314227", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "氯吡格雷怎样起作用：它经活性代谢物影响血小板 P2Y12 受体", "en": "How clopidogrel works: its active metabolite acts on platelet P2Y12 receptors" }, "summary": { "zh": "FDA 的 PLAVIX 处方信息描述：氯吡格雷的活性代谢物不可逆地结合血小板上的 P2Y12 类 ADP 受体，从而抑制血小板活化和聚集。该机制帮助读懂“抗血小板”这几个字；它不能决定个人是否该开始、停用、联用、围手术期怎样处理或何时恢复。", "en": "FDA's PLAVIX prescribing information describes clopidogrel's active metabolite as binding irreversibly to P2Y12-class ADP receptors on platelets, inhibiting platelet activation and aggregation. This helps explain “antiplatelet”; it cannot decide whether an individual should start, stop, combine medicines, manage a procedure or resume treatment." }, "checks": [ { "zh": "“血小板聚集”可理解为血小板彼此黏连形成血栓过程的一部分。机制说明的是一个受体通路，并不等于所有出血、胸痛、卒中样症状或即将手术的情况都能靠网页自行处理。", "en": "“Platelet aggregation” can be understood as part of the process in which platelets stick together. The mechanism describes one receptor pathway; it does not mean bleeding, chest pain, stroke-like symptoms or an upcoming procedure can be self-managed from a webpage." }, { "zh": "标签说明氯吡格雷需要经 CYP450 酶形成活性代谢物，并特别提到 CYP2C19 相关差异。它不表示每个人都应自行做检测或自行根据结果换药；已有检测报告应由专业人员连同适应症、完整药单与当地现行标签解释。", "en": "The label says clopidogrel requires CYP450 metabolism to form its active metabolite and specifically identifies CYP2C19-related variation. It does not mean everyone should self-order testing or change medicines based on a result; an existing report needs professional interpretation with the indication, complete medicine list and current local label." }, { "zh": "与阿司匹林、抗凝药、止痛药、草本、胃药或其他“防血栓”产品一起使用时，风险与收益不能仅凭“机制相同或不同”判断。尤其在异常出血、跌倒或头部受伤、手术和牙科操作前后，应按负责团队的具体指示处理，不能自行漏服、补服、叠加或停用。", "en": "With aspirin, anticoagulants, pain medicines, herbs, stomach medicines or another “blood-thinning” product, risk and benefit cannot be judged merely from whether mechanisms are the same or different. Especially with unusual bleeding, a fall or head injury, and before or after surgery or dental work, follow the responsible team's specific instructions rather than self-missing, making up, combining or stopping doses." } ], "source": { "id": "src_3e070dd8ebe91314", "label": "DailyMed（NLM）：PLAVIX 氯吡格雷当前美国公开标签（Mechanism of Action；2025-05-30 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=de8b0b67-eb25-4684-83b5-7ad785314227", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "Plavix", "generic": "氯吡格雷", "dosageFormClass": "PLAVIX／波立维硫酸氢氯吡格雷薄膜衣口服片：美国 75 mg、300 mg；中国大陆进口与国产产品页均列示 75 mg" }, "labelSource": { "id": "src_3e070dd8ebe91314", "label": "DailyMed（NLM）：PLAVIX 氯吡格雷当前美国公开标签（Sanofi-Aventis；2025-05-30 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=de8b0b67-eb25-4684-83b5-7ad785314227", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "productRoutes": [ { "source": { "id": "src_3e070dd8ebe91314", "label": "DailyMed（NLM）：PLAVIX 氯吡格雷当前美国公开标签（Sanofi-Aventis；2025-05-30 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=de8b0b67-eb25-4684-83b5-7ad785314227", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-30", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_11bf819ee616bfaa", "label": "赛诺菲中国：波立维®国产硫酸氢氯吡格雷片说明书（2025-09-01 修订）", "url": "https://www.sanofi.cn/assets/dot-cn/pages/docs/products/prescription-products/20250901-Plavix-tab-75mg-LMP-PI-update-chp2025-transfered.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "first_party_leaflet", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "status": "public_product_record_verified", "authority": { "zh": "公开产品记录来源", "en": "Public product-record source" }, "market": { "zh": "以原始文件为准", "en": "See original document" }, "recordType": { "zh": "公开产品记录", "en": "Public product record" }, "reviewedAt": "2026-08-30", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_3401fd02b94e49fe", "label": "赛诺菲中国：波立维®进口硫酸氢氯吡格雷片说明书（2025-05-22 修订）", "url": "https://www.sanofi.cn/assets/dot-cn/pages/docs/products/prescription-products/20250522-plavix-tab-75mg-LRP-PI-MAHD-variation-transferred.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "first_party_leaflet", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "status": "public_product_record_verified", "authority": { "zh": "公开产品记录来源", "en": "Public product-record source" }, "market": { "zh": "以原始文件为准", "en": "See original document" }, "recordType": { "zh": "公开产品记录", "en": "Public product record" }, "reviewedAt": "2026-08-30", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-30", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [ { "id": "fda-pharmacogenomic-label-record-clopidogrel", "issuedAt": "2025-12", "status": "fda_pharmacogenomic_label_record", "title": { "zh": "FDA 药物基因组标签记录：clopidogrel 与 CYP2C19", "en": "FDA pharmacogenomic label record: clopidogrel and CYP2C19" }, "summary": { "zh": "FDA 的药物基因组标签表将 clopidogrel（Plavix）列入与 CYP2C19 相关的标签信息项目。该表是美国监管机构对标签中基因组信息位置的索引，不等于每位使用者都需要筛查、已检测者就应自行改剂量，或可自行换成另一种药。是否检测、怎样解释结果及与其他药同用的问题，必须连同准确产品、适应症、现行标签和完整用药清单由开方团队或药师核对。", "en": "FDA’s Table of Pharmacogenomic Biomarkers in Drug Labeling lists clopidogrel (Plavix) with CYP2C19-related labeling information. The table is a U.S. regulator index to where genomic information appears in labeling; it does not mean every user needs screening, that a tested person should self-change a dose, or that another medicine may be substituted independently. Whether to test, how to interpret a result and how it relates to other medicines must be reviewed with the exact product, indication, current label and complete medicine list by the prescribing team or pharmacist." }, "source": { "id": "src_9f4d37bf0406cd2b", "label": "FDA：药品标签中的药物基因组生物标志物表", "url": "https://www.fda.gov/drugs/science-and-research-drugs/table-pharmacogenomic-biomarkers-drug-labeling/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "pharmacogenomic_label_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-2015-clopidogrel-plavix-long-term-treatment-safety-communication", "issuedAt": "2015-11-06", "status": "fda_drug_safety_communication", "title": { "zh": "FDA 药物安全通讯：Plavix／氯吡格雷长期治疗的死亡风险审查", "en": "FDA Drug Safety Communication: review of mortality risk with long-term Plavix/clopidogrel treatment" }, "summary": { "zh": "FDA 于 2015-11-06 发布美国药物安全通讯，说明其对 DAPT 试验及其他长期临床试验的复核未显示氯吡格雷会增加或降低心脏病患者或高风险人群的总体死亡风险，也未提示增加癌症或癌症死亡风险。该通讯讨论的是美国、特定试验背景下的长期抗血小板治疗证据；它不等于任何个人的出血、血栓、癌症、疗程、是否需要基因检测或联合用药判断，也不支持自行停用 Plavix／氯吡格雷或自行与阿司匹林、抗凝药、止痛药或其他产品轮换、叠加或替换。出现出血、胸痛、神经系统症状或其他急性不适时，应使用当地紧急医疗支持，并由开方团队或药师连同完整药单核对。", "en": "In a U.S. Drug Safety Communication issued on 2015-11-06, FDA said its review of the DAPT trial and other long-term clinical trials did not show that clopidogrel increases or decreases overall risk of death in people with, or at risk for, heart disease, and did not suggest increased cancer or cancer-death risk. The communication concerns evidence for long-term antiplatelet treatment in a specific U.S. trial context. It cannot determine an individual’s bleeding, clotting, cancer, treatment duration, need for genetic testing or co-medication plan, and it does not support self-stopping Plavix/clopidogrel or self-alternating, adding or replacing it with aspirin, anticoagulants, pain medicines or another product. Bleeding, chest pain, neurological symptoms or another acute concern needs local emergency support and review of the complete medicine list with the prescribing team or pharmacist." }, "source": { "id": "src_aed7d4adaf8a3f21", "label": "香港卫生署药物办公室：转载 FDA 2015-11-06 Plavix（clopidogrel）长期治疗安全通讯的官方安全警示档案", "url": "https://www.drugoffice.gov.hk/eps/news/showNews/The%2BUnited%2BStates%3A%2BDrug%2BSafety%2BCommunication%3A%2BFDA%2Breview%2Bfinds%2Blong-term%2Btreatment%2Bwith%2Bblood-thinning%2Bmedicine%2BPlavix%2B%28clopidogrel%29%2Bdoes%2Bnot%2Bchange%2Br/pharmaceutical_trade/2015-11-07/en/25341.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "PLAVIX／波立维是氯吡格雷口服薄膜衣片的市场品牌档案。美国当前标签有 75 mg 与 300 mg 两种准确产品呈现；中国大陆赛诺菲产品页同时列出进口和地产 75 mg 片剂，且两份说明书的包装与批准文号不同。页面先帮助核对品牌、通用名、每片标示量、市场、包装和说明书日期；不把 300 mg 当成可自行用多片 75 mg 拼出的方案，也不根据基因、相互作用或手术计划替个人停药、换药或安排片数。", "history": "FDA 的 PLAVIX 美国品牌档案始于 1997 年；DailyMed 当前公开标签生效于 2025-05-30。赛诺菲中国当前产品页把波立维®分别列为进口与地产 75 mg 片剂：2025-09-01 国产说明书列国药准字 H20056410 与 7/14/28/90 片硬双铝包装；2025-05-22 进口说明书列国药准字 HJ20171237/HJ20171238 与 7/28/90 片双铝泡罩包装。多立维®另含阿司匹林，是另一份复方产品，不能并入本单方档案。", "sourceDocuments": [ { "id": "src_3e070dd8ebe91314", "label": "DailyMed（NLM）：PLAVIX 氯吡格雷当前美国公开标签（Sanofi-Aventis；2025-05-30 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=de8b0b67-eb25-4684-83b5-7ad785314227", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, { "id": "src_772528a694d31352", "label": "赛诺菲中国：波立维®进口/地产 75 mg 产品页", "url": "https://www.sanofi.cn/zh/your-health/products/plavix", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "first_party_product_page", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, { "id": "src_11bf819ee616bfaa", "label": "赛诺菲中国：波立维®国产硫酸氢氯吡格雷片说明书（2025-09-01 修订）", "url": "https://www.sanofi.cn/assets/dot-cn/pages/docs/products/prescription-products/20250901-Plavix-tab-75mg-LMP-PI-update-chp2025-transfered.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "first_party_leaflet", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, { "id": "src_3401fd02b94e49fe", "label": "赛诺菲中国：波立维®进口硫酸氢氯吡格雷片说明书（2025-05-22 修订）", "url": "https://www.sanofi.cn/assets/dot-cn/pages/docs/products/prescription-products/20250522-plavix-tab-75mg-LRP-PI-MAHD-variation-transferred.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "first_party_leaflet", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, { "id": "src_da4e2fd483abd468", "label": "赛诺菲中国：多立维®氯吡格雷/阿司匹林复方产品页（单方 PLAVIX 的身份排除项）", "url": "https://www.sanofi.cn/zh/your-health/products/coplavix", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "first_party_product_page", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, { "id": "src_5ed30b676fbb9773", "label": "FDA Drugs@FDA：PLAVIX NDA 020839 检索入口", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_lookup_entry", "documentKind": "regulatory_lookup", "market": "US", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } ], "applicationNumber": "NDA 020839", "approvalTimeline": [ { "date": "1997", "title": { "zh": "FDA 标签所列美国初始批准年份", "en": "Initial U.S. approval year listed in the FDA label" }, "detail": { "zh": "本页链接的 FDA 标签档案列示 Initial U.S. Approval: 1997。该历史定位不等同于当前批准、可得性、持有人或其他市场状态。", "en": "The FDA label archive linked here lists Initial U.S. Approval: 1997. This historical locator is not a conclusion about current approval, availability, holder or another market." }, "source": { "id": "src_66da32e920670e55", "label": "FDA: PLAVIX label archive", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020839s078lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, { "date": "2022", "title": { "zh": "FDA 标签档案版本", "en": "FDA label archive version" }, "detail": { "zh": "本页链接 2022 的 FDA 标签档案作为可复核阅读入口。现行标签、规格、适应症和安全信息必须另行以目标市场当前文件核对。", "en": "This page links the 2022 FDA label archive as a traceable reading entry point. Current labeling, strength, indication and safety information require separate verification against the target market’s current document." }, "source": { "id": "src_66da32e920670e55", "label": "FDA: PLAVIX label archive", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020839s078lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "已链接公开标签档案", "en": "Public label archive linked" }, "detail": { "zh": "仅对应本页所列 FDA 文件。", "en": "Only the FDA document listed on this page is linked." } }, { "market": { "zh": "中国大陆、欧盟、日本", "en": "Mainland China, EU, Japan" }, "status": { "zh": "待逐项建立市场记录", "en": "Market record not established" }, "detail": { "zh": "不从美国标签档案推定当地批准、持有人、规格、供应或可售资格。", "en": "No local approval, holder, strength, supply or sale-eligibility conclusion is inferred from the U.S. label archive." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "标签档案能代表现在的产品信息吗？", "en": "Does a label archive represent current product information?" }, "answer": { "zh": "不能自动代表。档案用于定位来源；需要以目标市场的现行官方标签逐项复核。", "en": "Not automatically. The archive locates a source; each point needs verification against the target market’s current official label." } }, { "question": { "zh": "为什么这里不展示价格或原研/仿制结论？", "en": "Why are price and originator/generic conclusions not shown?" }, "answer": { "zh": "这些结论需要产品、剂型、规格、包装、市场、日期和原始记录分别齐全并经人工审核；单一标签文件不足以支持。", "en": "Those conclusions require separately complete and human-reviewed product, dosage-form, strength, pack, market, date and primary-record fields; one label file is insufficient." } } ], "relatedMedicineChecks": [ { "target": { "id": "nexium", "brand": "Nexium", "generic": "埃索美拉唑", "canonicalUrls": { "zh": "https://origindrug.com/drugs/nexium/", "en": "https://origindrug.com/en/drugs/nexium/" } }, "title": { "zh": "与 NEXIUM／埃索美拉唑同在药单上时：先做完整清单核对", "en": "When NEXIUM / esomeprazole is on the same list: review the complete list first" }, "summary": { "zh": "PLAVIX 的美国公开标签将奥美拉唑或埃索美拉唑列为需要核对的联用线索。本卡片只提示把所有实际药盒、非处方药和补充剂交给药师或开方团队复核；它不判断能否同服，也不建议自行停用、错开时间、替换或调整任何一种药。", "en": "The U.S. PLAVIX public label names omeprazole or esomeprazole as co-medication cues that need review. This card only signals that every actual pack, OTC product and supplement should be reviewed by a pharmacist or prescriber; it does not decide co-use or advise self-stopping, time-separation, replacement or adjustment of either medicine." }, "source": { "id": "src_3e070dd8ebe91314", "label": "DailyMed（NLM）：PLAVIX 氯吡格雷当前美国公开标签（Sanofi-Aventis；SPL v5，2025-06-11 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=de8b0b67-eb25-4684-83b5-7ad785314227", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "scope": "review_complete_medicine_list_no_self_directed_change" } ], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "how-to-read-a-drug-label", "regulatory-sources-first" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/clopidogrel-plavix/", "en": "https://origindrug.com/en/drugs/clopidogrel-plavix/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "adalimumab-humira", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-17", "status": "published_traceable_archive" }, "names": { "brand": "Humira", "generic": "阿达木单抗", "aliases": [ "修美乐", "adalimumab" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": { "value": "修美乐®", "status": "discovery_cue_requires_target_market_verification", "source": null } }, "identity": { "therapeuticArea": "免疫", "sourceArchiveMarket": "美国公开监管档案", "dosageFormClass": "皮下注射：预充式笔或预充式玻璃注射器（DailyMed 2025-12 标签所列）", "dosageFormClassCode": "subcutaneous_injection", "route": "皮下注射", "routeCode": "subcutaneous", "historicalApprovalEntry": "2002", "archiveSponsorText": "AbbVie Inc. / DailyMed 公开监管标签档案" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-humira-adalimumab-40mg-0-4ml-two-single-dose-prefilled-pens-ndc-0074-0554-02", "marketCode": "US", "labelVersion": { "zh": "DailyMed 美国公开标签（AbbVie；2025-12 更新）", "en": "DailyMed U.S. public label (AbbVie; updated Dec 2025)" }, "dosageForm": { "zh": "HUMIRA 阿达木单抗单剂量预充式注射笔", "en": "HUMIRA adalimumab single-dose prefilled pen" }, "route": { "zh": "皮下注射（标签产品身份字段）", "en": "subcutaneous injection (label product-identity field)" }, "routeCodes": [ "subcutaneous_injection" ], "productCode": "NDC 0074-0554-02", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_single_dose_prefilled_pen", "primaryDisplay": { "zh": "每支单剂量预充笔含阿达木单抗 40 mg/0.4 mL；29G 固定针；每盒 2 支", "en": "Adalimumab 40 mg/0.4 mL per single-dose prefilled pen; fixed 29-gauge needle; 2 pens per carton" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=humira-41.jpg&setid=608d4f0d-b19f-46d3-749a-7159aa5f933d&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "阿达木单抗", "en": "adalimumab" }, "value": 40, "unit": "mg", "basisCode": "per_single_dose_prefilled_pen", "basisLabel": { "zh": "每支单剂量预充笔的标签含量；不是个人注射量、次数、起始套装或换药规则", "en": "labelled content per single-dose prefilled pen; not an individual's injection amount, count, starter pack or switching rule" } } ], "concentration": null, "container": { "typeCode": "single_dose_prefilled_pen", "typeLabel": { "zh": "带 29G、1/2 英寸固定针的单剂量预充式笔", "en": "single-dose prefilled pen with fixed 29-gauge, 1/2-inch needle" }, "fill": { "value": 0.4, "unit": "mL" }, "countPerPackage": null, "countUnit": null }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-28", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 2, "unit": { "zh": "支单剂量预充笔/盒", "en": "single-dose prefilled pens per carton" } }, "physicalClues": { "color": null, "shape": { "zh": "HUMIRA PEN 两支装纸盒；每支笔置于独立剂量托盘", "en": "two-pen HUMIRA PEN carton; each pen is held in a separate dose tray" }, "imprint": null, "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_d45ff3899a43b5a5", "label": "DailyMed（NLM）：HUMIRA 40 mg/0.4 mL 两支预充式笔美国公开标签面板（AbbVie；2025-12 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=608d4f0d-b19f-46d3-749a-7159aa5f933d", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": null, "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=humira-41.jpg&setid=608d4f0d-b19f-46d3-749a-7159aa5f933d&type=img", "alt": "HUMIRA PEN 40 mg/0.4 mL 阿达木单抗在美国 DailyMed 公开标签中的 AbbVie 2 支预充式笔包装面板", "archiveMarket": "美国", "labelVersion": "DailyMed 公开标签（AbbVie Inc.，2025-12 更新）", "presentation": "HUMIRA PEN 40 mg/0.4 mL、2 支单剂量预充式笔包装面板（NDC 0074-0554-02；DailyMed 公开标签所列；AbbVie 包装面板）。", "notice": "此为美国 DailyMed 公开标签中明确对应 HUMIRA PEN 40 mg/0.4 mL、2 支单剂量预充式笔（NDC 0074-0554-02）的 AbbVie 包装面板，只帮助核对品牌、通用名、标示强度、注射体积、皮下注射、装置、包装数量和来源；不用于鉴定真伪，也不证明 80 mg/0.8 mL、40 mg/0.8 mL、20 mg/0.2 mL、10 mg/0.1 mL、预充式玻璃注射器、起始套装、其他包装、其他市场标签、当前包装、原研/生物类似药关系、目标市场批准或可售资格。", "source": { "id": "src_bc615f699dc585c5", "label": "DailyMed（NLM）：HUMIRA 公开标签（AbbVie Inc.，2025-12 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=608d4f0d-b19f-46d3-749a-7159aa5f933d", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "HUMIRA 说明书放大阅读：mg、mL、装置和盒数必须一起核对", "en": "HUMIRA label reading: check mg, mL, device and carton count together" }, "summary": { "zh": "本模块以 DailyMed 2025-12 美国标签为阅读入口，帮助核对 HUMIRA、adalimumab、皮下注射、预充式笔/玻璃注射器、mg/mL 与包装数量；不把包装信息变成个人注射、加量、换药或联合方案。", "en": "This module uses the DailyMed U.S. label updated in December 2025 as a reading entry point. It helps check HUMIRA, adalimumab, subcutaneous use, prefilled pen/syringe, mg/mL and carton count; it does not turn packaging information into an individual injection, adjustment, switch or combination plan." }, "checks": [ { "zh": "本页展示的图只对应 HUMIRA PEN 40 mg/0.4 mL、2 支单剂量预充式笔。40 mg 和 0.4 mL 必须作为同一产品身份一起读；“2 支”是该盒包装数量，不自动等于个人应使用的次数或周期。", "en": "The image on this page is only for HUMIRA PEN 40 mg/0.4 mL, two single-dose prefilled pens. Read 40 mg and 0.4 mL together as one product identity; “two pens” is the carton quantity, not an automatic statement of an individual schedule or number of uses." }, { "zh": "同一标签列有 80 mg/0.8 mL、40 mg/0.8 mL、40 mg/0.4 mL、20 mg/0.2 mL、10 mg/0.1 mL 等不同呈现。mg 数字相同不代表装置、体积、包装或方案相同；不能据此自行换算、拆分、合并或改用另一盒。", "en": "The same label lists 80 mg/0.8 mL, 40 mg/0.8 mL, 40 mg/0.4 mL, 20 mg/0.2 mL and 10 mg/0.1 mL presentations. The same mg number does not prove that the device, volume, package or regimen is the same; do not self-convert, split, combine or switch cartons from that fact." }, { "zh": "预充式笔和预充式玻璃注射器都是标签中单独列示的产品呈现。照片相似、名称相同或都是皮下注射，都不足以说明装置可互换、可以拆开、补用或由他人操作；以实际处方、具体产品说明和培训要求为准。", "en": "Prefilled pens and prefilled glass syringes are separately listed product presentations in the label. A similar photograph, matching name or the same subcutaneous route does not show that devices are interchangeable, may be opened, made up or administered by another person; use the actual prescription, product instructions and required training." }, { "zh": "标签含有严重感染、恶性肿瘤等重要警示，并对其他生物制品和活疫苗列出相互作用/使用边界。发热、感染症状、暴露史、疫苗安排或正在用的全部药物都应交给负责团队核对；网页不能判断个人何时注射、暂停、联用或改用。", "en": "The label includes major warnings such as serious infections and malignancy, and lists boundaries involving other biologic products and live vaccines. Fever, infection symptoms, exposure history, vaccination plans and every current medicine need review by the responsible team; a webpage cannot decide when an individual injects, pauses, combines or changes treatment." } ], "source": { "id": "src_bc615f699dc585c5", "label": "DailyMed（NLM）：HUMIRA 公开标签（AbbVie Inc.，2025-12 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=608d4f0d-b19f-46d3-749a-7159aa5f933d", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "阿达木单抗怎样起作用：它针对 TNF-α 信号，但机制不是自行用药规则", "en": "How adalimumab works: it targets TNF-alpha signalling, but mechanism is not a self-treatment rule" }, "summary": { "zh": "DailyMed 标签将阿达木单抗描述为 TNF 阻断剂：它特异性结合 TNF-α 并阻断其与细胞表面 TNF 受体的相互作用。该说明帮助读懂“TNF 抑制/阻断”，不能决定谁适合使用、如何切换、是否叠加或何时注射。", "en": "The DailyMed label describes adalimumab as a TNF blocker: it specifically binds TNF-alpha and blocks interaction with cell-surface TNF receptors. This helps read “TNF blockade”; it does not decide who is suitable, how to switch, whether to combine products or when to inject." }, "checks": [ { "zh": "TNF 是参与炎症和免疫反应的细胞因子；“阻断 TNF-α”描述的是药物靶点，并不等于可以从症状或某个化验值自行判断感染、疾病活动或下一针安排。", "en": "TNF is a cytokine involved in inflammatory and immune responses. “Blocking TNF-alpha” describes a drug target; it does not allow infection, disease activity or the next injection to be self-decided from symptoms or one laboratory value." }, { "zh": "机制相同、同为 TNF 抑制剂或同为生物制品，均不表示可自行叠加、交替或替代。标签对其他生物制品与活疫苗另列边界；变更前应由专业人员核对完整药单、感染风险、疫苗与具体产品。", "en": "A shared mechanism, TNF-blocker class or biologic status does not make products suitable for self-combination, alternation or substitution. The label separately sets boundaries for other biologics and live vaccines; a professional should review the complete medicine list, infection risk, vaccines and exact products before a change." }, { "zh": "包装与机制都不能替代注射装置培训、保存条件、实际处方或当地现行标签。对不确定的盒面、装置、剩余剂量或多药并用，应先让药师或负责团队核对实物与完整药单。", "en": "Neither packaging nor mechanism replaces device training, storage conditions, the actual prescription or current local labelling. For an uncertain carton, device, remaining dose or multiple medicines, have a pharmacist or the responsible team check the physical product and complete medicine list first." } ], "source": { "id": "src_bc615f699dc585c5", "label": "DailyMed（NLM）：HUMIRA 公开标签（AbbVie Inc.，2025-12 更新；12.1 机制）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=608d4f0d-b19f-46d3-749a-7159aa5f933d", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "Humira", "generic": "阿达木单抗", "dosageFormClass": "皮下注射：预充式笔或预充式玻璃注射器（DailyMed 2025-12 标签所列）" }, "labelSource": { "id": "src_bc615f699dc585c5", "label": "DailyMed（NLM）：HUMIRA 公开标签（AbbVie Inc.，2025-12 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=608d4f0d-b19f-46d3-749a-7159aa5f933d", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "productRoutes": [ { "source": { "id": "src_bc615f699dc585c5", "label": "DailyMed（NLM）：HUMIRA 公开标签（AbbVie Inc.，2025-12 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=608d4f0d-b19f-46d3-749a-7159aa5f933d", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_21f4718c4b517a98", "label": "FDA：HUMIRA 2020 美国标签档案（BLA 125057）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125057s415lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "DailyMed 的 HUMIRA（adalimumab）2025-12 美国公开标签列示其为皮下注射用制剂、美国初始批准年份为 2002，并明确区分预充式笔与预充式玻璃注射器。此页的包装图仅对应 40 mg/0.4 mL、2 支预充式笔；不能从这一个盒面推定其他浓度、针筒、起始套装、任何个人方案、其他市场或可售状态。", "history": "本页包装图仅对应美国 DailyMed 公开标签中 HUMIRA PEN 40 mg/0.4 mL、2 支单剂量预充式笔（NDC 0074-0554-02）。同一美国标签另列 80 mg/0.8 mL、40 mg/0.8 mL、20 mg/0.2 mL、10 mg/0.1 mL，以及预充式笔和玻璃注射器等不同呈现；商品名或“阿达木单抗”名称本身不能决定装置、规格、用法或可替代性。", "sourceDocuments": [ { "id": "src_bc615f699dc585c5", "label": "DailyMed（NLM）：HUMIRA 公开标签（AbbVie Inc.，2025-12 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=608d4f0d-b19f-46d3-749a-7159aa5f933d", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_21f4718c4b517a98", "label": "FDA：HUMIRA 2020 美国标签档案（BLA 125057）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125057s415lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_5ed30b676fbb9773", "label": "FDA Drugs@FDA 官方检索入口", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_lookup_entry", "documentKind": "regulatory_lookup", "market": "US", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } ], "applicationNumber": "BLA 125057", "approvalTimeline": [ { "date": "2002", "title": { "zh": "FDA 标签所列美国初始批准年份", "en": "Initial U.S. approval year listed in the FDA label" }, "detail": { "zh": "本页链接的 FDA 标签档案列示 Initial U.S. Approval: 2002。该历史定位不等同于当前批准、可得性、持有人或其他市场状态。", "en": "The FDA label archive linked here lists Initial U.S. Approval: 2002. This historical locator is not a conclusion about current approval, availability, holder or another market." }, "source": { "id": "src_21f4718c4b517a98", "label": "FDA: HUMIRA label archive", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125057s415lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, { "date": "2020", "title": { "zh": "FDA 标签档案版本", "en": "FDA label archive version" }, "detail": { "zh": "本页链接 2020 的 FDA 标签档案作为可复核阅读入口。现行标签、规格、适应症和安全信息必须另行以目标市场当前文件核对。", "en": "This page links the 2020 FDA label archive as a traceable reading entry point. Current labeling, strength, indication and safety information require separate verification against the target market’s current document." }, "source": { "id": "src_21f4718c4b517a98", "label": "FDA: HUMIRA label archive", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125057s415lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "已链接公开标签档案", "en": "Public label archive linked" }, "detail": { "zh": "仅对应本页所列 FDA 文件。", "en": "Only the FDA document listed on this page is linked." } }, { "market": { "zh": "中国大陆、欧盟、日本", "en": "Mainland China, EU, Japan" }, "status": { "zh": "待逐项建立市场记录", "en": "Market record not established" }, "detail": { "zh": "不从美国标签档案推定当地批准、持有人、规格、供应或可售资格。", "en": "No local approval, holder, strength, supply or sale-eligibility conclusion is inferred from the U.S. label archive." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "标签档案能代表现在的产品信息吗？", "en": "Does a label archive represent current product information?" }, "answer": { "zh": "不能自动代表。档案用于定位来源；需要以目标市场的现行官方标签逐项复核。", "en": "Not automatically. The archive locates a source; each point needs verification against the target market’s current official label." } }, { "question": { "zh": "为什么这里不展示价格或原研/仿制结论？", "en": "Why are price and originator/generic conclusions not shown?" }, "answer": { "zh": "这些结论需要产品、剂型、规格、包装、市场、日期和原始记录分别齐全并经人工审核；单一标签文件不足以支持。", "en": "Those conclusions require separately complete and human-reviewed product, dosage-form, strength, pack, market, date and primary-record fields; one label file is insufficient." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "dosage-forms-are-part-of-medicine-identity", "medicine-label-for-everyday-questions", "how-to-read-a-drug-label" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/adalimumab-humira/", "en": "https://origindrug.com/en/drugs/adalimumab-humira/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "clonidine-transdermal-catapres-tts", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-15", "status": "published_traceable_archive" }, "names": { "brand": "Catapres-TTS", "generic": "可乐定", "aliases": [ "可乐定贴", "clonidine transdermal", "clonidine", "clonidine transdermal system" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "心血管", "sourceArchiveMarket": "美国公开监管档案", "dosageFormClass": "经皮给药系统（贴剂）", "dosageFormClassCode": "transdermal_system", "route": "经皮", "routeCode": "transdermal", "historicalApprovalEntry": "1984-10-10（FDA 橙皮书中 NDA 018891 的 Catapres-TTS 产品日期）", "archiveSponsorText": "Boehringer Ingelheim（FDA 历史资料所列）" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-catapres-tts-1-clonidine-0-1mg-day-4-system-carton-8208920134", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（2026-01-06 更新；说明书 2025-11 修订）", "en": "Current U.S. DailyMed public label (updated 6 Jan 2026; label revised Nov 2025)" }, "dosageForm": { "zh": "CATAPRES-TTS-1 可乐定经皮给药系统", "en": "CATAPRES-TTS-1 clonidine transdermal system" }, "route": { "zh": "经皮（标签产品身份字段）", "en": "transdermal (label product-identity field)" }, "routeCodes": [ "transdermal" ], "productCode": "NDC 82089-201-34", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "delivered_per_day_over_one_week", "primaryDisplay": { "zh": "每日标称释放可乐定 0.1 mg，持续一周；每个系统总含量 3.09 mg；面积 4.33 cm²；每盒 4 个系统及 4 个固定贴", "en": "Nominal clonidine delivery 0.1 mg per day for one week; 3.09 mg total per system; 4.33 cm²; four systems plus four adhesive covers per carton" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=catapres-TTS-1-carton.jpg&id=943373", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "可乐定（每日标称释放）", "en": "clonidine (nominal delivery per day)" }, "value": 0.1, "unit": "mg", "basisCode": "delivered_per_day_over_one_week", "basisLabel": { "zh": "持续一周的每日标称释放量；不是个人贴数、时间或换药指令", "en": "nominal delivery per day for one week; not an individual patch count, timing or switching instruction" } }, { "ingredient": { "zh": "可乐定（每个经皮系统总含量）", "en": "clonidine (total per transdermal system)" }, "value": 3.09, "unit": "mg", "basisCode": "total_in_transdermal_system", "basisLabel": { "zh": "每个系统内总含量；不等于每日释放量", "en": "total amount in each system; not the amount delivered per day" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-28", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 4, "unit": { "zh": "个系统/盒，另附 4 个固定贴", "en": "systems per carton, plus 4 adhesive covers" } }, "physicalClues": { "color": { "zh": "棕褐色贴剂", "en": "tan patch" }, "shape": { "zh": "矩形经皮系统，面积 4.33 cm²；固定贴不含活性药物", "en": "rectangular transdermal system, 4.33 cm²; adhesive cover contains no active medication" }, "imprint": null, "scoreStatus": null, "patchAreaCm2": 4.33 }, "comparisonNotice": null, "source": { "id": "src_078dfe139aa7e63f", "label": "DailyMed（NLM）：CATAPRES-TTS 可乐定经皮给药系统当前美国公开标签（Technomed；2026-01-06 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=39e1d35e-533c-4647-8649-8168a6e92dfa&version=1", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-catapres-tts-2-clonidine-0-2mg-day-4-system-carton-8208920234", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（2026-01-06 更新；说明书 2025-11 修订）", "en": "Current U.S. DailyMed public label (updated 6 Jan 2026; label revised Nov 2025)" }, "dosageForm": { "zh": "CATAPRES-TTS-2 可乐定经皮给药系统", "en": "CATAPRES-TTS-2 clonidine transdermal system" }, "route": { "zh": "经皮（标签产品身份字段）", "en": "transdermal (label product-identity field)" }, "routeCodes": [ "transdermal" ], "productCode": "NDC 82089-202-34", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "delivered_per_day_over_one_week", "primaryDisplay": { "zh": "每日标称释放可乐定 0.2 mg，持续一周；每个系统总含量 6.19 mg；面积 8.67 cm²；每盒 4 个系统及 4 个固定贴", "en": "Nominal clonidine delivery 0.2 mg per day for one week; 6.19 mg total per system; 8.67 cm²; four systems plus four adhesive covers per carton" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "可乐定（每日标称释放）", "en": "clonidine (nominal delivery per day)" }, "value": 0.2, "unit": "mg", "basisCode": "delivered_per_day_over_one_week", "basisLabel": { "zh": "持续一周的每日标称释放量；不是个人贴数、时间或换药指令", "en": "nominal delivery per day for one week; not an individual patch count, timing or switching instruction" } }, { "ingredient": { "zh": "可乐定（每个经皮系统总含量）", "en": "clonidine (total per transdermal system)" }, "value": 6.19, "unit": "mg", "basisCode": "total_in_transdermal_system", "basisLabel": { "zh": "每个系统内总含量；不等于每日释放量", "en": "total amount in each system; not the amount delivered per day" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-28", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 4, "unit": { "zh": "个系统/盒，另附 4 个固定贴", "en": "systems per carton, plus 4 adhesive covers" } }, "physicalClues": { "color": { "zh": "棕褐色贴剂", "en": "tan patch" }, "shape": { "zh": "矩形经皮系统，面积 8.67 cm²；固定贴不含活性药物", "en": "rectangular transdermal system, 8.67 cm²; adhesive cover contains no active medication" }, "imprint": null, "scoreStatus": null, "patchAreaCm2": 8.67 }, "comparisonNotice": null, "source": { "id": "src_078dfe139aa7e63f", "label": "DailyMed（NLM）：CATAPRES-TTS 可乐定经皮给药系统当前美国公开标签（Technomed；2026-01-06 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=39e1d35e-533c-4647-8649-8168a6e92dfa&version=1", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-catapres-tts-3-clonidine-0-3mg-day-4-system-carton-8208920334", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（2026-01-06 更新；说明书 2025-11 修订）", "en": "Current U.S. DailyMed public label (updated 6 Jan 2026; label revised Nov 2025)" }, "dosageForm": { "zh": "CATAPRES-TTS-3 可乐定经皮给药系统", "en": "CATAPRES-TTS-3 clonidine transdermal system" }, "route": { "zh": "经皮（标签产品身份字段）", "en": "transdermal (label product-identity field)" }, "routeCodes": [ "transdermal" ], "productCode": "NDC 82089-203-34", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "delivered_per_day_over_one_week", "primaryDisplay": { "zh": "每日标称释放可乐定 0.3 mg，持续一周；每个系统总含量 9.28 mg；面积 13 cm²；每盒 4 个系统及 4 个固定贴", "en": "Nominal clonidine delivery 0.3 mg per day for one week; 9.28 mg total per system; 13 cm²; four systems plus four adhesive covers per carton" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "可乐定（每日标称释放）", "en": "clonidine (nominal delivery per day)" }, "value": 0.3, "unit": "mg", "basisCode": "delivered_per_day_over_one_week", "basisLabel": { "zh": "持续一周的每日标称释放量；不是个人贴数、时间或换药指令", "en": "nominal delivery per day for one week; not an individual patch count, timing or switching instruction" } }, { "ingredient": { "zh": "可乐定（每个经皮系统总含量）", "en": "clonidine (total per transdermal system)" }, "value": 9.28, "unit": "mg", "basisCode": "total_in_transdermal_system", "basisLabel": { "zh": "每个系统内总含量；不等于每日释放量", "en": "total amount in each system; not the amount delivered per day" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-28", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 4, "unit": { "zh": "个系统/盒，另附 4 个固定贴", "en": "systems per carton, plus 4 adhesive covers" } }, "physicalClues": { "color": { "zh": "棕褐色贴剂", "en": "tan patch" }, "shape": { "zh": "矩形经皮系统，面积 13 cm²；固定贴不含活性药物", "en": "rectangular transdermal system, 13 cm²; adhesive cover contains no active medication" }, "imprint": null, "scoreStatus": null, "patchAreaCm2": 13 }, "comparisonNotice": null, "source": { "id": "src_078dfe139aa7e63f", "label": "DailyMed（NLM）：CATAPRES-TTS 可乐定经皮给药系统当前美国公开标签（Technomed；2026-01-06 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=39e1d35e-533c-4647-8649-8168a6e92dfa&version=1", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": null, "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=catapres-TTS-1-carton.jpg&id=943373", "alt": "CATAPRES-TTS-1 可乐定经皮给药系统在美国 DailyMed Technomed 公开标签中的 0.1 mg/日、4 个系统及 4 个固定贴包装图", "archiveMarket": "美国", "labelVersion": "DailyMed 公开标签（Technomed，2026-01 更新）", "presentation": "CATAPRES-TTS-1（clonidine transdermal system）0.1 mg/日、4 个系统及 4 个固定贴的纸盒图（NDC 82089-201-34；DailyMed 公开标签所列）。", "notice": "此为美国 DailyMed Technomed 公开标签中明确对应 CATAPRES-TTS-1、0.1 mg/日、4 个系统及 4 个固定贴的纸盒图，只帮助核对品牌、通用名、经皮给药系统、每日标示释放量、包装数量和来源；不用于鉴定真伪，也不证明 -2/-3 强度、其他包装、其他市场标签、当前可得性、原研身份、目标市场批准或可售资格。", "source": { "id": "src_078dfe139aa7e63f", "label": "DailyMed（NLM）：CATAPRES-TTS 公开标签（Technomed，2026-01 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=39e1d35e-533c-4647-8649-8168a6e92dfa&version=1", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "Catapres-TTS 说明书放大阅读：贴剂面积、每日释放量与“多贴/剪开”不是可自行换算", "en": "Catapres-TTS label reading: patch area, stated daily release and “adding or cutting” are not self-conversion rules" }, "summary": { "zh": "本模块以 FDA 2021 美国标签为阅读入口，帮助核对 Catapres-TTS、可乐定经皮给药系统、-1/-2/-3 标识、每周贴剂与标签所列每日释放量；它不决定贴几张、何时更换、如何从口服药转换或如何停止使用。", "en": "This module uses the 2021 U.S. FDA label as a reading entry point. It helps check Catapres-TTS, clonidine transdermal system, the -1/-2/-3 identifiers, the weekly system and the labelled daily release; it does not decide patch number, replacement timing, conversion from oral medicine or discontinuation." }, "checks": [ { "zh": "把 Catapres-TTS、可乐定经皮给药系统、-1/-2/-3、每周使用和 0.1/0.2/0.3 mg/日等标签信息作为同一组产品身份核对。这些是准确贴剂的标示信息，不是自行多贴、剪开、叠加、补贴或换成口服可乐定的换算规则。", "en": "Check Catapres-TTS, clonidine transdermal system, -1/-2/-3, weekly use and the 0.1/0.2/0.3 mg-per-day label information as one product-identity set. These identify the exact system; they are not self-conversion rules for adding, cutting, layering, replacing or changing to oral clonidine." }, { "zh": "FDA 标签描述该贴剂为多层系统，并有控制释放的膜层。贴剂看起来松动、外观变化或感觉“药效不够”都不能用来推导自行裁剪、加大面积、补贴或改变使用方式；应带准确包装请药师或开方团队核对。", "en": "The FDA label describes a multilayer system with a rate-controlling membrane. A loose-looking system, a change in appearance or a feeling that it is “not enough” cannot be used to infer cutting, enlarging the area, adding another system or changing use; have the exact package reviewed by a pharmacist or prescribing team." }, { "zh": "同为可乐定、都与血压相关，不能证明贴剂与口服制剂或其他降压药可自行合用、替换或突然停用。若同时有 β 受体阻滞剂、部分钙通道阻滞剂、镇静性药物、饮酒或其他慢病药，应把完整药单和实际产品交由专业人员核对。", "en": "Sharing clonidine or a blood-pressure context does not prove that a patch, an oral form or another antihypertensive can be self-combined, substituted or suddenly stopped. With a beta blocker, certain calcium-channel blockers, sedating medicines, alcohol or other chronic-care products, have professionals review the complete list and actual products." }, { "zh": "贴敷处明显红肿、起疱或广泛皮疹，头晕、昏厥、心率异常相关不适，或 MRI、手术等特殊情形下对贴剂处理不确定时，应及时使用当地医疗和专业支持；本页不提供贴敷、移除或停用操作方案。", "en": "For marked redness, blistering or widespread rash at the application site, dizziness, fainting, symptoms related to an abnormal heart rate, or uncertainty about a patch around MRI, surgery or another special situation, use timely local medical and professional support; this page does not provide an application, removal or discontinuation plan." } ], "source": { "id": "src_1bfd095665169082", "label": "FDA：Catapres-TTS 2021 美国处方信息（NDA 018891）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/018891Orig1s032correctedlbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "可乐定怎样起作用：它作用于脑干 α 受体，降低交感神经输出", "en": "How clonidine works: it acts at brainstem alpha-adrenoreceptors and reduces sympathetic outflow" }, "summary": { "zh": "FDA 标签说明可乐定刺激脑干 α 肾上腺素能受体，降低中枢交感神经传出，并可降低外周阻力、心率和血压。它帮助理解为何多种降压或影响心率的药物需要一起核对；它不能计算贴剂数量、每日释放量、口服转换或停用方式。", "en": "The FDA label explains that clonidine stimulates brainstem alpha-adrenoreceptors, reduces central sympathetic outflow, and can lower peripheral resistance, heart rate and blood pressure. This helps explain why blood-pressure or heart-rate medicines need review together; it cannot calculate patch number, daily release, oral conversion or discontinuation." }, "checks": [ { "zh": "“降低交感神经输出”是作用机制，不会让同一通用名的口服制剂与贴剂相互等同，也不能由此推导应贴几张、何时更换或是否可以自行停用。准确产品、处方和现行标签必须一并核对。", "en": "“Reducing sympathetic outflow” is a mechanism, not a basis for treating an oral form and a patch with the same generic name as equivalent, or for deriving patch number, replacement timing or self-discontinuation. The exact product, prescription and current label must be checked together." }, { "zh": "该机制也解释了为什么 β 受体阻滞剂、部分钙通道阻滞剂和其他影响心率或血压的产品不能只按药名判断能否并用、替换或轮换。多药情形应交由药师或开方团队逐项复核。", "en": "This mechanism also helps explain why beta blockers, certain calcium-channel blockers and other products affecting heart rate or blood pressure cannot be judged by name alone for combination, substitution or alternation. Multiple medicines need item-by-item review by a pharmacist or prescribing team." }, { "zh": "困倦、头晕、低心率相关不适、血压变化或新的皮肤反应都不能从机制页面自行处理。若出现急性不适或考虑改变、移除任何贴剂，应及时使用当地专业支持，而不是从药理名词推导操作。", "en": "Drowsiness, dizziness, symptoms related to a low heart rate, blood-pressure changes or a new skin reaction cannot be self-managed from a mechanism page. With an acute concern or a plan to change or remove any system, use timely local professional support rather than derive an action from pharmacology terms." } ], "source": { "id": "src_1bfd095665169082", "label": "FDA：Catapres-TTS 2021 美国处方信息（临床药理）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/018891Orig1s032correctedlbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "Catapres-TTS", "generic": "可乐定", "dosageFormClass": "经皮给药系统（贴剂）" }, "labelSource": { "id": "src_1bfd095665169082", "label": "FDA：Catapres-TTS 公开标签", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/018891Orig1s032correctedlbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "productRoutes": [ { "source": { "id": "src_1bfd095665169082", "label": "FDA：Catapres-TTS 公开标签", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/018891Orig1s032correctedlbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "FDA 公开资料显示的经皮给药系统档案示例；贴剂不能按通用名与口服或注射制剂直接等同。", "history": "FDA 橙皮书历史清单将 NDA 018891 的 Catapres-TTS 产品日期列为 1984-10-10；另有 1996 年补充申请资料包。二者均为历史文件，不代表当前标签、规格、持有人、供应或可得性；任何市场的当前记录必须另行核验。", "sourceDocuments": [ { "id": "src_92083977907c29eb", "label": "FDA：橙皮书历史清单中的 Catapres-TTS（NDA 018891；产品日期 1984-10-10）", "url": "https://www.fda.gov/media/145882/download", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "regulatory_reference", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_d9e2d89cb3871208", "label": "FDA：Catapres-TTS 补充申请资料包", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/96/018891-S15_Catapres-TTS_toc.htm", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "approval_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_1bfd095665169082", "label": "FDA：Catapres-TTS 公开标签", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/018891Orig1s032correctedlbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_5ed30b676fbb9773", "label": "FDA Drugs@FDA", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_lookup_entry", "documentKind": "regulatory_lookup", "market": "US", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } ], "applicationNumber": "NDA 018891（另列 1996 年 S15 补充申请资料）", "approvalTimeline": [ { "date": "1984-10-10", "title": { "zh": "FDA 橙皮书历史产品日期", "en": "FDA Orange Book historical product date" }, "detail": { "zh": "FDA 橙皮书历史清单将 NDA 018891 的 Catapres-TTS 产品日期列为 1984-10-10。该历史清单不代表当前标签、规格、持有人、供应或其他市场状态。", "en": "An FDA Orange Book historical listing gives 10 Oct 1984 as the product date for Catapres-TTS under NDA 018891. This historical listing does not establish current labelling, strength, holder, supply or another-market status." }, "source": { "id": "src_92083977907c29eb", "label": "FDA: Orange Book historical listing for Catapres-TTS (NDA 018891; product date 10 Oct 1984)", "url": "https://www.fda.gov/media/145882/download", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "regulatory_reference", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, { "date": "1996-09-06", "title": { "zh": "FDA 补充申请资料包节点", "en": "FDA supplement-package entry" }, "detail": { "zh": "本页链接的 FDA Catapres-TTS 补充申请资料包记录 NDA 018891-S15 与 1996-09-06 节点。它不代表初始批准或当前产品状态。", "en": "The linked FDA Catapres-TTS supplement package records NDA 018891-S15 and a 6 Sep 1996 entry. It does not represent initial approval or current product status." }, "source": { "id": "src_d9e2d89cb3871208", "label": "FDA: Catapres-TTS supplement package", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/96/018891-S15_Catapres-TTS_toc.htm", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "approval_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, { "date": "2021", "title": { "zh": "FDA 经皮给药系统标签档案", "en": "FDA transdermal-system label archive" }, "detail": { "zh": "本页链接 FDA 2021 Catapres-TTS 标签档案，用于区分经皮系统与口服或注射制剂；现行标签和规格须以目标市场文件独立核对。", "en": "The linked 2021 FDA Catapres-TTS label archive helps distinguish a transdermal system from oral or injectable presentations; the current label and strength require independent target-market review." }, "source": { "id": "src_1bfd095665169082", "label": "FDA: Catapres-TTS label archive", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/018891Orig1s032correctedlbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "已链接公开档案", "en": "Public archive linked" }, "detail": { "zh": "仅对应本页列出的 FDA 补充申请及标签档案。", "en": "Only the FDA supplement package and label archive listed on this page are linked." } }, { "market": { "zh": "中国大陆、欧盟、日本", "en": "Mainland China, EU, Japan" }, "status": { "zh": "待逐项建立市场记录", "en": "Market record not established" }, "detail": { "zh": "不从美国历史文件推定当地批准、持有人、贴剂规格、供应或可售资格。", "en": "No local approval, holder, patch strength, supply or sale-eligibility conclusion is inferred from U.S. historical material." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "为什么贴剂不能只按通用名核验？", "en": "Why cannot a patch be checked by generic name alone?" }, "answer": { "zh": "经皮系统的释放设计、规格、材料和标签版本都需单独核对；照片或通用名不能建立与口服或注射剂的等同性。", "en": "A transdermal system’s release design, strength, materials and label version each need separate review; a photo or generic name cannot establish equivalence with oral or injectable products." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "dosage-forms-are-part-of-medicine-identity", "how-to-read-a-drug-label" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/clonidine-transdermal-catapres-tts/", "en": "https://origindrug.com/en/drugs/clonidine-transdermal-catapres-tts/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "trastuzumab-herceptin", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-15", "status": "published_traceable_archive" }, "names": { "brand": "HERCEPTIN", "generic": "曲妥珠单抗", "aliases": [ "赫赛汀", "trastuzumab" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": { "value": "赫赛汀®", "status": "discovery_cue_requires_target_market_verification", "source": { "id": "src_0cf1228d3cfef899", "label": "NMPA：注射用曲妥珠单抗生物类似药临床试验指导原则（2020，历史资料线索）", "url": "https://www.nmpa.gov.cn/directory/web/nmpa/images/16LJ5NPDxrN19bptaWucn6zuA4MvG0qnB2bSyytTR6da4tbzUrdTyLnBkZg%3D%3D.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "regulatory_reference", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } } }, "identity": { "therapeuticArea": "肿瘤与血液", "sourceArchiveMarket": "美国公开监管档案", "dosageFormClass": "静脉输注用注射剂", "dosageFormClassCode": "intravenous_infusion", "route": "静脉输注", "routeCode": "intravenous", "historicalApprovalEntry": "1998", "archiveSponsorText": "Genentech（FDA 1998 年历史批准信所列）" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-herceptin-trastuzumab-150mg-single-dose-vial-1-vial-carton-5024213201", "marketCode": "US", "labelVersion": { "zh": "DailyMed 美国公开标签（Genentech；2026-05 更新）", "en": "DailyMed U.S. public label (Genentech; updated May 2026)" }, "dosageForm": { "zh": "HERCEPTIN 曲妥珠单抗静脉输注用冻干粉", "en": "HERCEPTIN trastuzumab lyophilised powder for intravenous infusion" }, "route": { "zh": "复溶并稀释后静脉输注（仅为标签产品身份；不是操作指令）", "en": "intravenous infusion after reconstitution and dilution (label identity only; not a procedure instruction)" }, "routeCodes": [ "intravenous_infusion" ], "productCode": "NDC 50242-132-01", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_single_dose_vial", "primaryDisplay": { "zh": "每个单剂量瓶含曲妥珠单抗 150 mg 冻干粉；1 瓶装纸盒", "en": "Trastuzumab 150 mg lyophilised powder per single-dose vial; one-vial carton" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=herceptin-08.jpg&setid=492dbdb2-077e-4064-bff3-372d6af0a7a2&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "曲妥珠单抗", "en": "trastuzumab" }, "value": 150, "unit": "mg", "basisCode": "per_single_dose_vial", "basisLabel": { "zh": "每个单剂量瓶的标签含量；不是个人输注量、瓶数、复溶或稀释方案", "en": "labelled content per single-dose vial; not an individual's infusion amount, vial count, reconstitution or dilution plan" } } ], "concentration": null, "container": { "typeCode": "single_dose_vial_lyophilised_powder", "typeLabel": { "zh": "无防腐剂、白色至淡黄色冻干粉单剂量瓶", "en": "preservative-free, white-to-pale-yellow lyophilised-powder single-dose vial" }, "fill": null, "countPerPackage": null, "countUnit": null }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-28", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 1, "unit": { "zh": "个单剂量瓶/盒", "en": "single-dose vials per carton" } }, "physicalClues": { "color": null, "shape": { "zh": "150 mg 冻干粉单剂量玻璃瓶及纸盒", "en": "150 mg lyophilised-powder single-dose glass vial and carton" }, "imprint": null, "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_14c234c883680f84", "label": "DailyMed（NLM）：HERCEPTIN 150 mg 单剂量冻干粉瓶、1 瓶纸盒美国公开标签（Genentech；2026-05 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=492dbdb2-077e-4064-bff3-372d6af0a7a2", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-herceptin-trastuzumab-150mg-single-dose-vial-10-vial-carton-5024213210", "marketCode": "US", "labelVersion": { "zh": "DailyMed 美国公开标签（Genentech；2026-05 更新）", "en": "DailyMed U.S. public label (Genentech; updated May 2026)" }, "dosageForm": { "zh": "HERCEPTIN 曲妥珠单抗静脉输注用冻干粉", "en": "HERCEPTIN trastuzumab lyophilised powder for intravenous infusion" }, "route": { "zh": "复溶并稀释后静脉输注（仅为标签产品身份；不是操作指令）", "en": "intravenous infusion after reconstitution and dilution (label identity only; not a procedure instruction)" }, "routeCodes": [ "intravenous_infusion" ], "productCode": "NDC 50242-132-10", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_single_dose_vial", "primaryDisplay": { "zh": "每个单剂量瓶含曲妥珠单抗 150 mg 冻干粉；10 瓶装纸盒", "en": "Trastuzumab 150 mg lyophilised powder per single-dose vial; ten-vial carton" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "曲妥珠单抗", "en": "trastuzumab" }, "value": 150, "unit": "mg", "basisCode": "per_single_dose_vial", "basisLabel": { "zh": "每个单剂量瓶的标签含量；不是个人输注量、瓶数、复溶或稀释方案", "en": "labelled content per single-dose vial; not an individual's infusion amount, vial count, reconstitution or dilution plan" } } ], "concentration": null, "container": { "typeCode": "single_dose_vial_lyophilised_powder", "typeLabel": { "zh": "无防腐剂、白色至淡黄色冻干粉单剂量瓶", "en": "preservative-free, white-to-pale-yellow lyophilised-powder single-dose vial" }, "fill": null, "countPerPackage": null, "countUnit": null }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-28", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 10, "unit": { "zh": "个单剂量瓶/盒", "en": "single-dose vials per carton" } }, "physicalClues": { "color": null, "shape": { "zh": "150 mg 冻干粉单剂量玻璃瓶及纸盒", "en": "150 mg lyophilised-powder single-dose glass vial and carton" }, "imprint": null, "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_14c234c883680f84", "label": "DailyMed（NLM）：HERCEPTIN 150 mg 单剂量冻干粉瓶、10 瓶纸盒美国公开标签（Genentech；2026-05 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=492dbdb2-077e-4064-bff3-372d6af0a7a2", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": null, "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=herceptin-08.jpg&setid=492dbdb2-077e-4064-bff3-372d6af0a7a2&type=img", "alt": "HERCEPTIN 曲妥珠单抗在美国 DailyMed Genentech 公开标签中的 150 mg 单剂量瓶纸盒正面图", "archiveMarket": "美国", "labelVersion": "DailyMed 公开标签（Genentech，2026-05 更新）", "presentation": "HERCEPTIN 注射用冻干粉：每瓶曲妥珠单抗 150 mg，单剂量瓶纸盒正面图（DailyMed Genentech 公开标签所列）。", "notice": "此为美国 DailyMed Genentech 公开标签中明确对应 HERCEPTIN、曲妥珠单抗 150 mg 单剂量瓶的纸盒图，只帮助核对品牌、通用名、剂型、标示强度、单剂量瓶和来源；不用于鉴定真伪，也不证明其他规格、其他给药形式、其他市场标签、当前可得性、原研身份、目标市场批准或可售资格。", "source": { "id": "src_d2b31628d6586924", "label": "DailyMed（NLM）：HERCEPTIN 公开标签（Genentech，2026-05 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=492dbdb2-077e-4064-bff3-372d6af0a7a2", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "HERCEPTIN 说明书放大阅读：150 mg 单剂量粉针不等于同名皮下制剂或其他 HER2 药", "en": "HERCEPTIN label reading: a 150 mg single-dose powder vial is not a same-name subcutaneous product or another HER2 medicine" }, "summary": { "zh": "本模块以 Genentech 的美国 DailyMed 2026-05 HERCEPTIN 公开标签为阅读入口，帮助核对 HERCEPTIN、曲妥珠单抗、150 mg 单剂量冻干粉针、静脉输注和目标市场；它不把瓶身规格、复溶文字、漏用处理或 HER2 检测术语变成个人输注、居家操作或换药方案。", "en": "This module uses Genentech's May 2026 U.S. DailyMed public label for HERCEPTIN as a reading entry point. It helps check HERCEPTIN, trastuzumab, a 150 mg single-dose lyophilised-powder vial, intravenous infusion and target market; it does not turn vial strength, reconstitution text, missed-visit information or HER2 test terminology into an individual infusion, home procedure or switching plan." }, "checks": [ { "zh": "150 mg 描述这一准确单剂量冻干粉针的总含量，并不等于一次个人治疗量、可自行稀释的毫升数，或可保存/分装的余量。标签所列复溶、稀释、输注、贮存与废弃步骤属于治疗机构的无菌药品操作，不应从网页在家复现。", "en": "150 mg describes total content of this exact single-dose lyophilised-powder vial; it is not an individual treatment amount, a self-calculated diluent volume or product that may be saved/shared. The label's reconstitution, dilution, infusion, storage and disposal steps are sterile medication operations for the treating facility and should not be recreated at home from a webpage." }, { "zh": "这份标签是静脉输注用 HERCEPTIN 标签，与皮下曲妥珠单抗产品有不同给药说明；也明确不应与 ado-trastuzumab emtansine 或 fam-trastuzumab deruxtecan 互相替代。相同“曲妥珠单抗”字样、HER2 名称或相近包装不能支持自行换用、合用、漏用后补回或改变疗程。", "en": "This is an intravenous HERCEPTIN label and has different administration instructions from subcutaneous trastuzumab products; it also states that it must not be substituted for or with ado-trastuzumab emtansine or fam-trastuzumab deruxtecan. Shared trastuzumab wording, HER2 terminology or similar packages do not support self-switching, combining, catch-up use or changing a course." }, { "zh": "标签警示心肌病、输注反应、肺毒性和胚胎-胎儿风险。呼吸困难、胸部不适、明显低血压样不适、发热寒战、持续咳嗽、异常乏力、浮肿或其他急性问题时，应及时联系肿瘤团队或使用当地紧急医疗支持；不要依据网页自行暂停或重启输注。", "en": "The label warns about cardiomyopathy, infusion reactions, pulmonary toxicity and embryo-fetal risk. With breathing difficulty, chest symptoms, marked low-blood-pressure-like illness, fever/chills, persistent cough, unusual fatigue, swelling or another acute concern, contact the oncology team promptly or use local urgent medical support; do not self-pause or restart infusions from a webpage." }, { "zh": "HER2 过表达、基因扩增或检测结果是特定疾病场景中由授权检测和专业团队综合解释的条件，不是看到一个检测名或数值即可自行判断是否应使用 HERCEPTIN。病理、检测方法、肿瘤类型、心功能、既往治疗与目标市场现行标签都须一并核对。", "en": "HER2 overexpression, gene amplification or a test result are conditions interpreted together by authorised testing and specialist teams in specific disease settings, not a basis for self-deciding on HERCEPTIN from one test name or value. Pathology, method, tumour type, cardiac function, prior treatment and the current target-market label must be reviewed together." } ], "source": { "id": "src_d2b31628d6586924", "label": "DailyMed（NLM）：HERCEPTIN 公开标签（Genentech，2026-05 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=492dbdb2-077e-4064-bff3-372d6af0a7a2", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "曲妥珠单抗怎样起作用：标签描述其针对 HER2 过表达肿瘤细胞的作用", "en": "How trastuzumab works: the label describes activity against tumour cells that overexpress HER2" }, "summary": { "zh": "FDA 的 HERCEPTIN 标签描述曲妥珠单抗可抑制 HER2 过表达的人肿瘤细胞增殖，并可介导抗体依赖的细胞毒作用（ADCC）。这只解释标签中的机制路径；它不判断任何人的肿瘤是否符合相关检测条件、是否适用、应使用哪种曲妥珠单抗制剂、与何种治疗联用或何时开始/停止。", "en": "The FDA HERCEPTIN label describes trastuzumab as inhibiting proliferation of human tumour cells that overexpress HER2 and as mediating antibody-dependent cellular cytotoxicity (ADCC). This explains a label-described mechanism only; it does not determine whether a person's tumour meets relevant testing criteria, suitability, which trastuzumab product to use, combination treatment, or when to start/stop." }, "checks": [ { "zh": "“HER2”“靶向”或“抗体”不是凭一份旧检测报告、药名或网络信息自行判断能否使用的依据。病理检测的类型、样本、时间、目标市场标签、疾病阶段、心脏评估与完整治疗方案必须由肿瘤团队一起确认。", "en": "“HER2,” “targeted” or “antibody” is not a basis for deciding use from an old test report, medicine name or online information. Test type, specimen, timing, target-market label, disease setting, cardiac assessment and the complete treatment plan must be confirmed together by an oncology team." }, { "zh": "同一通用名或相似名称的静脉制剂、皮下复方制剂、生物类似药与不同市场产品不能从机制页面推断为可自行换算、互换或叠加。给药途径、制剂成分、剂量单位和专业给药安排都必须逐项核对。", "en": "Intravenous products, subcutaneous combination products, biosimilars and products from different markets with the same generic or a similar name cannot be assumed self-convertible, interchangeable or combinable from a mechanism page. Route, formulation ingredients, dose units and professional administration plan must each be checked." }, { "zh": "机制也不能解释或处理输注/注射反应、呼吸不适、胸部不适、心功能相关症状或其他急性问题。发生急性或严重不适时，应立即按当地肿瘤治疗团队和紧急医疗渠道处理，而不是根据网页调整方案。", "en": "Mechanism also cannot explain or manage an infusion/injection reaction, breathing trouble, chest discomfort, cardiac-function-related symptoms or another acute concern. For an acute or severe issue, use the local oncology team and emergency pathway immediately rather than adjusting from a webpage." } ], "source": { "id": "src_8d371ccc40f91c78", "label": "FDA：HERCEPTIN 2026 美国标签（临床药理）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/103792s5359lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "HERCEPTIN", "generic": "曲妥珠单抗", "dosageFormClass": "静脉输注用注射剂" }, "labelSource": { "id": "src_8d371ccc40f91c78", "label": "FDA：HERCEPTIN 静脉输注标签", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/103792s5359lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "productRoutes": [ { "source": { "id": "src_8d371ccc40f91c78", "label": "FDA：HERCEPTIN 静脉输注标签", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/103792s5359lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "以 FDA 历史批准信与现行标签为入口的静脉输注档案；不得按通用名、照片或历史资料将其与皮下制剂或其他抗 HER2 产品直接等同。", "history": "FDA 的 HERCEPTIN 公开批准信与标签可用于阅读静脉输注这一给药途径。国家药监局 2020 年公开指导原则也以 Herceptin／赫赛汀作为曲妥珠单抗生物类似药的历史背景资料；该指导文件不能替代中国大陆当前产品记录。当前持有人、标签、输注条件和可得性必须按目标市场另行核验。", "sourceDocuments": [ { "id": "src_63b9839d33f24ec9", "label": "FDA：HERCEPTIN 生物制品批准信", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/trasgen092598L.htm", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "approval_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_8d371ccc40f91c78", "label": "FDA：HERCEPTIN 静脉输注标签", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/103792s5359lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_0cf1228d3cfef899", "label": "NMPA：注射用曲妥珠单抗生物类似药临床试验指导原则（2020，历史资料线索）", "url": "https://www.nmpa.gov.cn/directory/web/nmpa/images/16LJ5NPDxrN19bptaWucn6zuA4MvG0qnB2bSyytTR6da4tbzUrdTyLnBkZg%3D%3D.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "regulatory_reference", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_5ed30b676fbb9773", "label": "FDA Drugs@FDA", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_lookup_entry", "documentKind": "regulatory_lookup", "market": "US", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } ], "applicationNumber": "FDA historical approval letter (1998)", "approvalTimeline": [ { "date": "1998", "title": { "zh": "FDA 标签所列美国初始批准年份", "en": "Initial U.S. approval year listed in the FDA label" }, "detail": { "zh": "本页链接的 FDA 标签档案列示 Initial U.S. Approval: 1998。该历史定位不等同于当前批准、可得性、持有人或其他市场状态。", "en": "The FDA label archive linked here lists Initial U.S. Approval: 1998. This historical locator is not a conclusion about current approval, availability, holder or another market." }, "source": { "id": "src_8d371ccc40f91c78", "label": "FDA: HERCEPTIN intravenous-infusion label archive", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/103792s5359lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, { "date": "2026", "title": { "zh": "FDA 标签档案版本", "en": "FDA label archive version" }, "detail": { "zh": "本页链接 2026 的 FDA 标签档案作为可复核阅读入口。现行标签、规格、适应症和安全信息必须另行以目标市场当前文件核对。", "en": "This page links the 2026 FDA label archive as a traceable reading entry point. Current labeling, strength, indication and safety information require separate verification against the target market’s current document." }, "source": { "id": "src_8d371ccc40f91c78", "label": "FDA: HERCEPTIN intravenous-infusion label archive", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/103792s5359lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, { "date": "2020", "title": { "zh": "NMPA 历史资料线索", "en": "NMPA historical reference" }, "detail": { "zh": "国家药监局 2020 年公开指导原则以 Herceptin／赫赛汀作为曲妥珠单抗生物类似药的历史背景资料。该文件仅提供历史检索线索，不构成中国大陆当前批准、持有人、标签、供应或可售资格结论。", "en": "A 2020 NMPA public guidance document uses Herceptin/赫赛汀 as historical background for trastuzumab biosimilar development. It is a historical search reference only, not a conclusion about current Mainland China approval, holder, labelling, supply or sale eligibility." }, "source": { "id": "src_0cf1228d3cfef899", "label": "NMPA：注射用曲妥珠单抗生物类似药临床试验指导原则（2020，历史资料线索）", "url": "https://www.nmpa.gov.cn/directory/web/nmpa/images/16LJ5NPDxrN19bptaWucn6zuA4MvG0qnB2bSyytTR6da4tbzUrdTyLnBkZg%3D%3D.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "regulatory_reference", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "已链接公开标签档案", "en": "Public label archive linked" }, "detail": { "zh": "仅对应本页所列 FDA 文件。", "en": "Only the FDA document listed on this page is linked." } }, { "market": { "zh": "中国大陆、欧盟、日本", "en": "Mainland China, EU, Japan" }, "status": { "zh": "待逐项建立市场记录", "en": "Market record not established" }, "detail": { "zh": "不从美国标签档案推定当地批准、持有人、规格、供应或可售资格。", "en": "No local approval, holder, strength, supply or sale-eligibility conclusion is inferred from the U.S. label archive." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "标签档案能代表现在的产品信息吗？", "en": "Does a label archive represent current product information?" }, "answer": { "zh": "不能自动代表。档案用于定位来源；需要以目标市场的现行官方标签逐项复核。", "en": "Not automatically. The archive locates a source; each point needs verification against the target market’s current official label." } }, { "question": { "zh": "为什么这里不展示价格或原研/仿制结论？", "en": "Why are price and originator/generic conclusions not shown?" }, "answer": { "zh": "这些结论需要产品、剂型、规格、包装、市场、日期和原始记录分别齐全并经人工审核；单一标签文件不足以支持。", "en": "Those conclusions require separately complete and human-reviewed product, dosage-form, strength, pack, market, date and primary-record fields; one label file is insufficient." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "dosage-forms-are-part-of-medicine-identity", "medicine-label-for-everyday-questions", "how-to-read-a-drug-label" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/trastuzumab-herceptin/", "en": "https://origindrug.com/en/drugs/trastuzumab-herceptin/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "rituximab-rituxan", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-15", "status": "published_traceable_archive" }, "names": { "brand": "RITUXAN", "generic": "利妥昔单抗", "aliases": [ "美罗华", "rituximab" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": { "value": "美罗华®", "status": "discovery_cue_requires_target_market_verification", "source": { "id": "src_405ac20ea088ffca", "label": "NMPA：利妥昔单抗注射液生物类似药临床试验指导原则（含中国商品名“美罗华”历史资料线索）", "url": "https://www.nmpa.gov.cn/directory/web/nmpa/images/wPvN1870taWudeiyeTSusn6zuA4MvG0qnB2bSyytTR6da4tbzUrdTyLnBkZg%3D%3D.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "regulatory_reference", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } } }, "identity": { "therapeuticArea": "肿瘤与血液", "sourceArchiveMarket": "美国公开监管档案", "dosageFormClass": "静脉输注用注射剂", "dosageFormClassCode": "intravenous_infusion", "route": "静脉输注", "routeCode": "intravenous", "historicalApprovalEntry": "1997", "archiveSponsorText": "Genentech（FDA 1997 年历史批准信所列）" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-rituxan-rituximab-100mg-10ml-single-dose-vial-5024205121", "marketCode": "US", "labelVersion": { "zh": "DailyMed 美国公开标签（Genentech；2025-01 页面更新）", "en": "DailyMed U.S. public label (Genentech; page updated Jan 2025)" }, "dosageForm": { "zh": "RITUXAN 利妥昔单抗静脉输注用注射液", "en": "RITUXAN rituximab injection for intravenous infusion" }, "route": { "zh": "稀释后静脉输注（仅为标签产品身份；不是操作指令）", "en": "intravenous infusion after dilution (label identity only; not a procedure instruction)" }, "routeCodes": [ "intravenous_infusion" ], "productCode": "NDC 50242-051-21", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_single_dose_vial", "primaryDisplay": { "zh": "每个单剂量瓶含利妥昔单抗 100 mg/10 mL（10 mg/mL）；每盒 1 瓶", "en": "Rituximab 100 mg/10 mL (10 mg/mL) per single-dose vial; one vial per carton" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=rituxan-04.jpg&setid=b172773b-3905-4a1c-ad95-bab4b6126563&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "利妥昔单抗", "en": "rituximab" }, "value": 100, "unit": "mg", "basisCode": "per_single_dose_vial", "basisLabel": { "zh": "每个单剂量瓶的标签总量；不是个人输注量、瓶数、稀释或输注方案", "en": "labelled total per single-dose vial; not an individual's infusion amount, vial count, dilution or infusion plan" } } ], "concentration": null, "container": { "typeCode": "single_dose_vial", "typeLabel": { "zh": "无防腐剂单剂量瓶", "en": "preservative-free single-dose vial" }, "fill": { "value": 10, "unit": "mL" }, "countPerPackage": null, "countUnit": null }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-28", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 1, "unit": { "zh": "个单剂量瓶/盒", "en": "single-dose vial per carton" } }, "physicalClues": { "color": { "zh": "澄清、无色溶液（标签描述）", "en": "clear, colourless solution (label description)" }, "shape": { "zh": "10 mL 单剂量玻璃瓶及纸盒", "en": "10 mL single-dose glass vial and carton" }, "imprint": null, "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_165ab4011d15d5dd", "label": "DailyMed（NLM）：RITUXAN 100 mg/10 mL 单剂量瓶美国公开标签（Genentech）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b172773b-3905-4a1c-ad95-bab4b6126563", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-rituxan-rituximab-500mg-50ml-single-dose-vial-5024205306", "marketCode": "US", "labelVersion": { "zh": "DailyMed 美国公开标签（Genentech；2025-01 页面更新）", "en": "DailyMed U.S. public label (Genentech; page updated Jan 2025)" }, "dosageForm": { "zh": "RITUXAN 利妥昔单抗静脉输注用注射液", "en": "RITUXAN rituximab injection for intravenous infusion" }, "route": { "zh": "稀释后静脉输注（仅为标签产品身份；不是操作指令）", "en": "intravenous infusion after dilution (label identity only; not a procedure instruction)" }, "routeCodes": [ "intravenous_infusion" ], "productCode": "NDC 50242-053-06", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_single_dose_vial", "primaryDisplay": { "zh": "每个单剂量瓶含利妥昔单抗 500 mg/50 mL（10 mg/mL）；每盒 1 瓶", "en": "Rituximab 500 mg/50 mL (10 mg/mL) per single-dose vial; one vial per carton" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=rituxan-05.jpg&setid=b172773b-3905-4a1c-ad95-bab4b6126563&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "利妥昔单抗", "en": "rituximab" }, "value": 500, "unit": "mg", "basisCode": "per_single_dose_vial", "basisLabel": { "zh": "每个单剂量瓶的标签总量；不是个人输注量、瓶数、稀释或输注方案", "en": "labelled total per single-dose vial; not an individual's infusion amount, vial count, dilution or infusion plan" } } ], "concentration": null, "container": { "typeCode": "single_dose_vial", "typeLabel": { "zh": "无防腐剂单剂量瓶", "en": "preservative-free single-dose vial" }, "fill": { "value": 50, "unit": "mL" }, "countPerPackage": null, "countUnit": null }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-28", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 1, "unit": { "zh": "个单剂量瓶/盒", "en": "single-dose vial per carton" } }, "physicalClues": { "color": { "zh": "澄清、无色溶液（标签描述）", "en": "clear, colourless solution (label description)" }, "shape": { "zh": "50 mL 单剂量玻璃瓶及纸盒", "en": "50 mL single-dose glass vial and carton" }, "imprint": null, "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_165ab4011d15d5dd", "label": "DailyMed（NLM）：RITUXAN 500 mg/50 mL 单剂量瓶美国公开标签（Genentech）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b172773b-3905-4a1c-ad95-bab4b6126563", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": null, "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=rituxan-04.jpg&setid=b172773b-3905-4a1c-ad95-bab4b6126563&type=img", "alt": "RITUXAN 利妥昔单抗在美国 DailyMed Genentech 公开标签中的 100 mg/10 mL 单剂量瓶纸盒图", "archiveMarket": "美国", "labelVersion": "DailyMed 公开标签（Genentech，2025-01 更新）", "presentation": "RITUXAN 注射液：100 mg/10 mL（10 mg/mL）、单剂量瓶纸盒图（DailyMed Genentech 公开标签所列）。", "notice": "此为美国 DailyMed Genentech 公开标签中明确对应 RITUXAN、利妥昔单抗 100 mg/10 mL（10 mg/mL）单剂量瓶的纸盒图，只帮助核对品牌、通用名、剂型、标示浓度、单剂量瓶和来源；不用于鉴定真伪，也不证明其他规格、其他给药形式、其他市场标签、当前可得性、原研身份、目标市场批准或可售资格。", "source": { "id": "src_4f99c2e1cf1d1ffd", "label": "DailyMed（NLM）：RITUXAN 公开标签（Genentech，2025-01 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=b172773b-3905-4a1c-ad95-bab4b6126563", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "RITUXAN 说明书放大阅读：10 mg/mL 单剂量瓶不是家庭输注或分装用量", "en": "RITUXAN label reading: a 10 mg/mL single-dose vial is not for home infusion or dose sharing" }, "summary": { "zh": "本模块以 Genentech 的美国 DailyMed 2025-01 RITUXAN 公开标签为阅读入口，帮助核对 RITUXAN、利妥昔单抗、静脉用注射剂、100 mg/10 mL 或 500 mg/50 mL（均为 10 mg/mL）单剂量瓶及目标市场；它不把浓度、瓶数、输注顺序或任何疾病名称变成个人方案。", "en": "This module uses Genentech's January 2025 U.S. DailyMed public label for RITUXAN as a reading entry point. It helps check RITUXAN, rituximab, injection for intravenous use, 100 mg/10 mL or 500 mg/50 mL (both 10 mg/mL) single-dose vials and target market; it does not turn concentration, vial count, infusion sequence or a disease name into an individual plan." }, "checks": [ { "zh": "100 mg/10 mL 与 500 mg/50 mL 是两种单剂量瓶的产品身份线索，10 mg/mL 是浓度；这些数字不等于“自己该用几瓶”、可以把余量留到下次或可分给他人。RITUXAN 标签明确它仅能由具备处理严重输注反应医疗支持的专业人员静脉输注，实际配制、输注和剩余处置必须由治疗机构负责。", "en": "100 mg/10 mL and 500 mg/50 mL are product-identity clues for two single-dose vials, and 10 mg/mL is a concentration; these numbers are not “how many vials to use,” permission to save leftovers or share product. The RITUXAN label states it is to be given intravenously only by professionals with medical support for severe infusion reactions; actual preparation, infusion and remaining-product handling belong to the treating facility." }, { "zh": "同为“单抗”、CD20 相关治疗或静脉用药，不表示 RITUXAN 能与另一种利妥昔单抗产品、化疗、免疫抑制剂、激素或其他生物制剂自行叠加、轮换或替代。疾病场景、既往疗程、感染风险、疫苗、完整药单和目标市场标签需要由开方团队一起核对。", "en": "Being called an antibody, a CD20-related treatment or an intravenous medicine does not make RITUXAN self-combinable, alternatable or substitutable with another rituximab product, chemotherapy, immunosuppressant, steroid or biologic. Disease setting, prior course, infection risk, vaccinations, the full medicine list and the target-market label need integrated review by the prescribing team." }, { "zh": "标签对严重输注反应、严重皮肤/黏膜反应、乙肝病毒再激活、进行性多灶性白质脑病、感染及其他风险有明确警示。输注期间或之后出现呼吸困难、胸部不适、明显皮疹/黏膜损害、发热感染征象、黄疸样变化、意识/神经变化、严重腹痛或其他急性问题，应及时联系治疗团队或使用当地紧急医疗支持。", "en": "The label carries explicit warnings about severe infusion reactions, severe skin/mucosal reactions, hepatitis B virus reactivation, progressive multifocal leukoencephalopathy, infection and other risks. With breathing difficulty, chest symptoms, marked rash/mucosal injury, fever or infection signs, jaundice-like changes, mental/neurologic change, severe abdominal pain or another acute concern during or after infusion, contact the treatment team promptly or use local urgent medical support." }, { "zh": "“CD20 阳性”、淋巴瘤、关节炎或自身免疫病等词汇不能由网页自行转成适用结论。相关检测、病理、感染/乙肝记录、既往治疗和现行标签必须由相应专科团队解释；不要因同名或相似适应症自行启动、暂停或更换。", "en": "Terms such as “CD20-positive,” lymphoma, arthritis or autoimmune disease cannot be turned into a suitability conclusion by a webpage. Relevant testing, pathology, infection/hepatitis B record, prior treatment and current label require interpretation by the appropriate specialty team; do not self-start, pause or switch because names or indications look similar." } ], "source": { "id": "src_4f99c2e1cf1d1ffd", "label": "DailyMed（NLM）：RITUXAN 公开标签（Genentech，2025-01 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=b172773b-3905-4a1c-ad95-bab4b6126563", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "利妥昔单抗怎样起作用：标签描述其与 B 细胞表面的 CD20 结合", "en": "How rituximab works: the label describes binding to CD20 on B cells" }, "summary": { "zh": "FDA 的 RITUXAN 标签将利妥昔单抗描述为可与成熟 B 淋巴细胞和前 B 淋巴细胞表面的 CD20 抗原结合的单克隆抗体；标签还描述其可通过补体依赖细胞毒、抗体依赖细胞毒和直接凋亡诱导等途径参与作用。这解释作用路径，不判断个人疾病是否适用、感染风险、疫苗安排、联合治疗或给药时间。", "en": "The FDA RITUXAN label describes rituximab as a monoclonal antibody that binds CD20 on mature and pre-B lymphocytes; it also describes complement-dependent cytotoxicity, antibody-dependent cytotoxicity and direct apoptosis induction as possible pathways. This explains action pathways, not individual disease suitability, infection risk, vaccine planning, combination treatment or timing." }, "checks": [ { "zh": "“作用于 B 细胞”不表示可以根据病名、化验单片段或机制自行判断是否需要治疗，或与其他免疫抑制、抗肿瘤、激素或生物制剂自行叠加、轮换或停用。", "en": "“Acts on B cells” does not permit a treatment decision from a diagnosis name, partial laboratory result or mechanism, nor self-combination, alternation or stopping with another immunosuppressant, anticancer medicine, steroid or biologic." }, { "zh": "RITUXAN、其他利妥昔单抗产品、生物类似药及不同给药设置必须按准确产品、给药途径、标签、输注方案和目标市场记录逐项核对；共同的 CD20 机制不等于可自行互换。", "en": "RITUXAN, another rituximab product, a biosimilar and different administration settings must be checked item by item for exact product, route, label, infusion plan and target-market record; a shared CD20 mechanism does not mean self-interchangeability." }, { "zh": "标签含有严重输注反应、感染与其他风险警示。发热、寒战、呼吸困难、皮疹、意识改变或其他急性不适时，应及时联系当地治疗团队或紧急医疗支持；不能以机制页面替代风险评估。", "en": "The label contains warnings about serious infusion reactions, infections and other risks. With fever, chills, breathing trouble, rash, mental-status change or another acute concern, contact the local treatment team or urgent medical support promptly; a mechanism page cannot replace risk assessment." } ], "source": { "id": "src_0d2b93571c630223", "label": "FDA：RITUXAN 2019 美国标签（临床药理）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/103705s5457lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "RITUXAN", "generic": "利妥昔单抗", "dosageFormClass": "静脉输注用注射剂" }, "labelSource": { "id": "src_0d2b93571c630223", "label": "FDA：RITUXAN 公开标签", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/103705s5457lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "productRoutes": [ { "source": { "id": "src_0d2b93571c630223", "label": "FDA：RITUXAN 公开标签", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/103705s5457lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "以 FDA 历史批准信与标签为入口的静脉输注档案；不得按通用名、照片或历史资料将其与皮下、口服或贴剂产品直接等同。", "history": "FDA 的 RITUXAN 公开历史批准信和标签可用于阅读静脉输注这一给药途径。历史文件和标签可能不是最新版本；任何市场的当前持有人、标签、输注条件和可得性必须另行核验。", "sourceDocuments": [ { "id": "src_dbae68351375fb09", "label": "FDA：Rituximab 历史批准信", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1997/ritugen112697l.htm", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "approval_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_0d2b93571c630223", "label": "FDA：RITUXAN 公开标签", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/103705s5457lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_5ed30b676fbb9773", "label": "FDA Drugs@FDA", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_lookup_entry", "documentKind": "regulatory_lookup", "market": "US", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } ], "applicationNumber": "BLA 103705", "approvalTimeline": [ { "date": "1997", "title": { "zh": "FDA 标签所列美国初始批准年份", "en": "Initial U.S. approval year listed in the FDA label" }, "detail": { "zh": "本页链接的 FDA 标签档案列示 Initial U.S. Approval: 1997。该历史定位不等同于当前批准、可得性、持有人或其他市场状态。", "en": "The FDA label archive linked here lists Initial U.S. Approval: 1997. This historical locator is not a conclusion about current approval, availability, holder or another market." }, "source": { "id": "src_0d2b93571c630223", "label": "FDA: RITUXAN label archive", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/103705s5457lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, { "date": "2019", "title": { "zh": "FDA 标签档案版本", "en": "FDA label archive version" }, "detail": { "zh": "本页链接 2019 的 FDA 标签档案作为可复核阅读入口。现行标签、规格、适应症和安全信息必须另行以目标市场当前文件核对。", "en": "This page links the 2019 FDA label archive as a traceable reading entry point. Current labeling, strength, indication and safety information require separate verification against the target market’s current document." }, "source": { "id": "src_0d2b93571c630223", "label": "FDA: RITUXAN label archive", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/103705s5457lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "已链接公开标签档案", "en": "Public label archive linked" }, "detail": { "zh": "仅对应本页所列 FDA 文件。", "en": "Only the FDA document listed on this page is linked." } }, { "market": { "zh": "中国大陆、欧盟、日本", "en": "Mainland China, EU, Japan" }, "status": { "zh": "待逐项建立市场记录", "en": "Market record not established" }, "detail": { "zh": "不从美国标签档案推定当地批准、持有人、规格、供应或可售资格。", "en": "No local approval, holder, strength, supply or sale-eligibility conclusion is inferred from the U.S. label archive." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "标签档案能代表现在的产品信息吗？", "en": "Does a label archive represent current product information?" }, "answer": { "zh": "不能自动代表。档案用于定位来源；需要以目标市场的现行官方标签逐项复核。", "en": "Not automatically. The archive locates a source; each point needs verification against the target market’s current official label." } }, { "question": { "zh": "为什么这里不展示价格或原研/仿制结论？", "en": "Why are price and originator/generic conclusions not shown?" }, "answer": { "zh": "这些结论需要产品、剂型、规格、包装、市场、日期和原始记录分别齐全并经人工审核；单一标签文件不足以支持。", "en": "Those conclusions require separately complete and human-reviewed product, dosage-form, strength, pack, market, date and primary-record fields; one label file is insufficient." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "dosage-forms-are-part-of-medicine-identity", "medicine-label-for-everyday-questions", "how-to-read-a-drug-label" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/rituximab-rituxan/", "en": "https://origindrug.com/en/drugs/rituximab-rituxan/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "rosuvastatin-crestor", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-30", "status": "published_traceable_archive" }, "names": { "brand": "CRESTOR", "generic": "瑞舒伐他汀钙", "aliases": [ "可定", "可定®", "瑞舒伐他汀", "瑞舒伐他汀钙片", "クレストール", "rosuvastatin", "rosuvastatin calcium" ], "marketBrandNames": [ { "name": "クレストール", "market": { "zh": "日本", "en": "Japan" }, "evidenceStatus": "current_regulatory_record", "note": { "zh": "PMDA 当前产品页列示クレストール普通片与 OD 口崩片的 2.5 mg、5 mg 规格；不同剂型和市场记录不能据此自行互换。", "en": "The current PMDA product page lists CRESTOR (クレストール) 2.5 mg and 5 mg conventional and orally disintegrating tablets; different forms and market records must not be self-interchanged." }, "source": { "id": "src_eb05083a584bc9be", "label": "PMDA：クレストール錠 2.5 mg／5 mg及 OD 錠 2.5 mg／5 mg 当前产品页", "url": "https://www.pmda.go.jp/PmdaSearch/rdDetail/iyaku/2189017F1022_1?user=1", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, { "name": "可定®", "market": { "zh": "中国大陆（阿斯利康中国当前产品组合页）", "en": "Mainland China (current AstraZeneca China product-portfolio page)" }, "evidenceStatus": "current_first_party_product_listing", "note": { "zh": "阿斯利康中国当前心血管、肾脏及代谢产品组合页列示可定®（瑞舒伐他汀钙片）5 mg、10 mg、20 mg。该企业页面建立品牌、通用名和规格线索，但不替代 NMPA 批准记录、现行说明书、批准文号、包装或供应核验。", "en": "AstraZeneca China's current cardiovascular, renal and metabolic product-portfolio page lists CRESTOR (可定®), rosuvastatin calcium tablets, in 5 mg, 10 mg and 20 mg strengths. This first-party page establishes brand, generic-name and strength cues, but does not replace NMPA approval records, the current leaflet, approval numbers, packaging or supply verification." }, "source": { "id": "src_74aa269ebb2ff692", "label": "阿斯利康中国：心血管、肾脏及代谢主要产品——可定®（瑞舒伐他汀钙片）5 mg／10 mg／20 mg（2026-08-30 复核）", "url": "https://www.astrazeneca.com.cn/zh/our-focus-areas/cvm.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "first_party_product_page", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" } } ], "mainlandChinaTradeNameCue": { "value": "可定®", "status": "discovery_cue_requires_target_market_verification", "source": null } }, "identity": { "therapeuticArea": "心血管", "sourceArchiveMarket": "美国 DailyMed 有日期公开标签（SPL v14，2026-05-13 发布；本档案分别展示四个准确包装面板）；日本 PMDA 当前产品记录（クレストール錠／OD 錠）；阿斯利康中国当前心血管、肾脏及代谢产品组合页列示可定®（瑞舒伐他汀钙片）5 mg、10 mg、20 mg，未据此推定批准文号、现行说明书、包装、库存或可售资格", "dosageFormClass": "美国 DailyMed 包衣片：5 mg、10 mg、20 mg、40 mg；阿斯利康中国产品组合页：可定® 瑞舒伐他汀钙片 5 mg、10 mg、20 mg；日本 PMDA：2.5 mg、5 mg 普通片与 OD 口崩片（市场、剂型和规格不得混写或自行换算）", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "2003", "archiveSponsorText": "AstraZeneca / DailyMed 公开标签档案" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-crestor-tablet-5mg-ndc-0310-7560-90", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v14，2026-05-13 发布", "en": "DailyMed SPL v14, published 13 May 2026" }, "dosageForm": { "zh": "CRESTOR 瑞舒伐他汀口服薄膜衣片", "en": "CRESTOR rosuvastatin film-coated oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 0310-7560-90", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片 5 mg；90 片瓶装", "en": "5 mg per tablet; 90-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=325a5d0e-9a72-4015-9fcd-1655fb504cee&type=img&name=CRESTOR_5mg.jpg", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "瑞舒伐他汀", "en": "rosuvastatin" }, "value": 5, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标示量；不是个人片数或换药规则", "en": "labelled amount per tablet; not an individual's tablet count or switching rule" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 90, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-20", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 90, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "黄色", "en": "yellow" }, "shape": { "zh": "圆形、双凸包衣片", "en": "round biconvex coated tablet" }, "imprint": "ZD4522 / 5", "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_fe1f4e0e8fa117d2", "label": "DailyMed（NLM）：CRESTOR 瑞舒伐他汀当前美国公开标签（AstraZeneca；SPL v14，2026-05-13 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=325a5d0e-9a72-4015-9fcd-1655fb504cee", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-crestor-tablet-10mg-ndc-0310-7570-90", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v14，2026-05-13 发布", "en": "DailyMed SPL v14, published 13 May 2026" }, "dosageForm": { "zh": "CRESTOR 瑞舒伐他汀口服薄膜衣片", "en": "CRESTOR rosuvastatin film-coated oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 0310-7570-90", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片 10 mg；90 片瓶装", "en": "10 mg per tablet; 90-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=325a5d0e-9a72-4015-9fcd-1655fb504cee&type=img&name=CRESTOR_10mg.jpg", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "瑞舒伐他汀", "en": "rosuvastatin" }, "value": 10, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标示量；不是个人片数或换药规则", "en": "labelled amount per tablet; not an individual's tablet count or switching rule" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 90, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-20", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 90, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "粉红色", "en": "pink" }, "shape": { "zh": "圆形、双凸包衣片", "en": "round biconvex coated tablet" }, "imprint": "ZD4522 / 10", "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_fe1f4e0e8fa117d2", "label": "DailyMed（NLM）：CRESTOR 瑞舒伐他汀当前美国公开标签（AstraZeneca；SPL v14，2026-05-13 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=325a5d0e-9a72-4015-9fcd-1655fb504cee", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-crestor-tablet-20mg-ndc-0310-7580-90", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v14，2026-05-13 发布", "en": "DailyMed SPL v14, published 13 May 2026" }, "dosageForm": { "zh": "CRESTOR 瑞舒伐他汀口服薄膜衣片", "en": "CRESTOR rosuvastatin film-coated oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 0310-7580-90", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片 20 mg；90 片瓶装", "en": "20 mg per tablet; 90-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=325a5d0e-9a72-4015-9fcd-1655fb504cee&type=img&name=CRESTOR_20mg.jpg", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "瑞舒伐他汀", "en": "rosuvastatin" }, "value": 20, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标示量；不是个人片数或换药规则", "en": "labelled amount per tablet; not an individual's tablet count or switching rule" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 90, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-20", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 90, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "粉红色", "en": "pink" }, "shape": { "zh": "圆形、双凸包衣片", "en": "round biconvex coated tablet" }, "imprint": "ZD4522 / 20", "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_fe1f4e0e8fa117d2", "label": "DailyMed（NLM）：CRESTOR 瑞舒伐他汀当前美国公开标签（AstraZeneca；SPL v14，2026-05-13 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=325a5d0e-9a72-4015-9fcd-1655fb504cee", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-crestor-tablet-40mg-ndc-0310-7590-30", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v14，2026-05-13 发布", "en": "DailyMed SPL v14, published 13 May 2026" }, "dosageForm": { "zh": "CRESTOR 瑞舒伐他汀口服薄膜衣片", "en": "CRESTOR rosuvastatin film-coated oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 0310-7590-30", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片 40 mg；30 片瓶装", "en": "40 mg per tablet; 30-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=325a5d0e-9a72-4015-9fcd-1655fb504cee&type=img&name=CRESTOR__40mg.jpg", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "瑞舒伐他汀", "en": "rosuvastatin" }, "value": 40, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标示量；不是个人片数或换药规则", "en": "labelled amount per tablet; not an individual's tablet count or switching rule" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-20", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 30, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "粉红色", "en": "pink" }, "shape": { "zh": "椭圆形、双凸包衣片", "en": "oval biconvex coated tablet" }, "imprint": "ZD4522 / 40", "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_fe1f4e0e8fa117d2", "label": "DailyMed（NLM）：CRESTOR 瑞舒伐他汀当前美国公开标签（AstraZeneca；SPL v14，2026-05-13 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=325a5d0e-9a72-4015-9fcd-1655fb504cee", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-crestor-tablet-10mg-ndc-0310-7570-90", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=325a5d0e-9a72-4015-9fcd-1655fb504cee&type=img&name=CRESTOR_10mg.jpg", "alt": "CRESTOR 瑞舒伐他汀在美国 DailyMed AstraZeneca 当前公开标签中的 10 mg、NDC 0310-7570-90、90 片瓶装展示面", "archiveMarket": "美国", "labelVersion": "DailyMed SPL v14（2026-05-13 发布）", "presentation": "CRESTOR 瑞舒伐他汀：每片 10 mg，NDC 0310-7570-90，90 片瓶装展示面。", "notice": "此图只对应美国 DailyMed 当前标签中的 CRESTOR、瑞舒伐他汀 10 mg、NDC 0310-7570-90 与 90 片瓶装。它只帮助核对品牌、通用名、每片标示量、片剂、包装数量与来源；不用于鉴定真伪，也不证明 5 mg、20 mg、40 mg、其他包装、其他市场、当前可得性、原研身份、可替代性或任何个人的片数、联用、分片、开始、停用或换药方案。", "source": { "id": "src_fe1f4e0e8fa117d2", "label": "DailyMed（NLM）：CRESTOR 瑞舒伐他汀当前美国公开标签（AstraZeneca；SPL v14，2026-05-13 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=325a5d0e-9a72-4015-9fcd-1655fb504cee", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "CRESTOR 说明书放大阅读：规格、外观与联用要分开看", "en": "CRESTOR label reading: separate strength, appearance and combination questions" }, "summary": { "zh": "本模块以美国 DailyMed SPL v14（2026-05-13 发布）为阅读入口。它说明不同规格与外观是产品身份线索，但不替任何人决定应选哪种他汀、是否换药或是否需要基因检测。", "en": "This module uses the current U.S. DailyMed SPL v14, published 13 May 2026, as a reading entry point. Different strengths and appearances are identity clues, but they do not decide which statin an individual should use, whether to switch or whether genetic testing is needed." }, "checks": [ { "zh": "该美国标签把 5、10、20、40 mg 分别作为不同的片剂强度，并描述了颜色、形状和刻字。强度、外观和刻字共同帮助核对产品；不应仅凭一项或照片判断真伪、当前市场包装或可替代性。", "en": "The U.S. label lists 5, 10, 20 and 40 mg as different tablet strengths and describes colour, shape and debossing. Strength, appearance and debossing together help check a product; a single clue or photo cannot authenticate it, establish current market packaging or establish interchangeability." }, { "zh": "阿斯利康中国当前产品组合页列示可定®瑞舒伐他汀钙片 5、10、20 mg，但没有因此把美国 40 mg、日本 2.5 mg 或 OD 口崩片并入中国包装。看到“可定”后仍要继续核对实际药盒上的通用名、每片强度、剂型、批准文号、说明书版本与目标市场；企业产品列表不是个人片数或跨市场换算表。", "en": "AstraZeneca China's current product-portfolio page lists CRESTOR (可定®) rosuvastatin calcium tablets in 5, 10 and 20 mg strengths, but that does not merge the U.S. 40 mg tablet, Japanese 2.5 mg tablet or Japanese OD tablet into a Chinese package. After seeing the brand name, continue checking the actual pack's generic name, strength per tablet, dosage form, approval number, leaflet version and target market. A company product list is not an individual tablet count or a cross-market conversion table." }, { "zh": "阿托伐他汀与瑞舒伐他汀同属他汀类，但这不等于“今天各吃一颗”或可自行轮换。任何合用、转换、停用或调整，都需要按现行标签、完整用药清单、既往反应和临床资料由专业人员确认。", "en": "Atorvastatin and rosuvastatin are both statins, but that does not mean “one of each today” or self-directed alternation is appropriate. Any combination, switch, stop or adjustment needs professional confirmation using the current label, full medicine list, prior reactions and clinical information." }, { "zh": "标签会把某些联用药物列为需要避免、限制或额外核对的情况；这不能被简化为通用“安全/不安全”清单。每次新增或停用处方药、非处方药、保健品或草本时，都应主动请药师核对。", "en": "The label identifies some co-medications that need avoidance, limits or extra review; that cannot be simplified into a universal “safe/unsafe” list. When starting or stopping any prescription medicine, OTC product, supplement or herb, ask a pharmacist to review it." }, { "zh": "如已有基因检测报告，专业人员可结合报告、肾肝功能、既往肌肉症状和全部用药判断是否相关。OriginDrug 不把“做全基因筛查”作为自行选择、停用或改变他汀的前提。", "en": "If a genetic report already exists, a professional can assess whether it is relevant alongside kidney/liver function, prior muscle symptoms and all medicines. OriginDrug does not present universal genetic screening as a prerequisite for self-selecting, stopping or changing a statin." } ], "source": { "id": "src_fe1f4e0e8fa117d2", "label": "DailyMed（NLM）：CRESTOR 瑞舒伐他汀当前美国公开标签（AstraZeneca；SPL v14，2026-05-13 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=325a5d0e-9a72-4015-9fcd-1655fb504cee", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "瑞舒伐他汀怎样起作用：同样作用于 HMG‑CoA 还原酶，但不等于与另一种他汀可自行互换", "en": "How rosuvastatin works: it also acts on HMG‑CoA reductase, which does not make it self-interchangeable with another statin" }, "summary": { "zh": "FDA 标签在临床药理部分将瑞舒伐他汀描述为 HMG‑CoA 还原酶的选择性、竞争性抑制剂。该机制帮助理解其药物类别；它不能单独回答某个人该选哪一种他汀、是否可联用、是否需调整或该做何种检测。", "en": "In Clinical Pharmacology, the FDA label describes rosuvastatin as a selective, competitive inhibitor of HMG‑CoA reductase. This mechanism helps explain its drug class; it cannot by itself answer which statin a person should use, whether products can be combined, whether an adjustment is needed or which testing is appropriate." }, "checks": [ { "zh": "标签描述的作用路径涉及抑制胆固醇合成中的 HMG‑CoA 还原酶，并与肝脏 LDL 受体等后续变化相关。把它理解为“药物在哪个环节起作用”即可，不应把这段说明读成个人疗效排序或剂量公式。", "en": "The label describes a pathway involving inhibition of HMG‑CoA reductase in cholesterol synthesis and downstream changes including hepatic LDL receptors. Read this as where a medicine acts—not as a personal efficacy ranking or dose formula." }, { "zh": "阿托伐他汀与瑞舒伐他汀都属于他汀类，但相同药理类别不能证明二者在某个市场、剂型、强度或个人情况下可等量替换，更不能支持同日各服一颗。", "en": "Atorvastatin and rosuvastatin are both statins, but a shared pharmacologic class does not prove equal substitution in a given market, formulation, strength or individual situation, and does not support taking one of each on the same day." }, { "zh": "若担心肌肉症状、相互作用、肾肝功能或已有药物基因检测结果，最有效的下一步是带上准确药盒和完整药单由专业人员按现行标签复核；机制说明不能替代这一步。", "en": "With concerns about muscle symptoms, interactions, kidney/liver function or an existing pharmacogenomic result, the most useful next step is review of the exact package and complete medicine list against the current label with a professional; a mechanism explanation cannot replace that step." } ], "source": { "id": "src_fe1f4e0e8fa117d2", "label": "DailyMed（NLM）：CRESTOR 瑞舒伐他汀当前美国公开标签（Clinical Pharmacology；SPL v14，2026-05-13 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=325a5d0e-9a72-4015-9fcd-1655fb504cee", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "CRESTOR", "generic": "瑞舒伐他汀钙", "dosageFormClass": "美国 DailyMed 包衣片：5 mg、10 mg、20 mg、40 mg；阿斯利康中国产品组合页：可定® 瑞舒伐他汀钙片 5 mg、10 mg、20 mg；日本 PMDA：2.5 mg、5 mg 普通片与 OD 口崩片（市场、剂型和规格不得混写或自行换算）" }, "labelSource": { "id": "src_fe1f4e0e8fa117d2", "label": "DailyMed（NLM）：CRESTOR 瑞舒伐他汀当前美国公开标签（AstraZeneca；SPL v14，2026-05-13 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=325a5d0e-9a72-4015-9fcd-1655fb504cee", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "productRoutes": [ { "source": { "id": "src_fe1f4e0e8fa117d2", "label": "DailyMed（NLM）：CRESTOR 瑞舒伐他汀当前美国公开标签（AstraZeneca；SPL v14，2026-05-13 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=325a5d0e-9a72-4015-9fcd-1655fb504cee", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_4f777b38d4dbbdd4", "label": "FDA：CRESTOR 2024-07 标签档案", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/021366s046lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_eb05083a584bc9be", "label": "PMDA：クレストール錠 2.5 mg／5 mg及 OD 錠 2.5 mg／5 mg 当前产品页", "url": "https://www.pmda.go.jp/PmdaSearch/rdDetail/iyaku/2189017F1022_1?user=1", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "status": "product_level_public_record_verified", "authority": { "zh": "PMDA", "en": "PMDA" }, "market": { "zh": "日本", "en": "Japan" }, "recordType": { "zh": "监管产品记录", "en": "Regulatory product record" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [ { "id": "fda-2021-statin-pregnancy-breastfeeding-safety-communication", "issuedAt": "2021-07-20", "status": "fda_class_safety_communication", "title": { "zh": "FDA 药物安全通讯：他汀类药物在妊娠与哺乳期的标签变更", "en": "FDA Drug Safety Communication: labelling changes for statins in pregnancy and breastfeeding" }, "summary": { "zh": "FDA 于 2021-07-20 就整个他汀类发布安全通讯，明确列出 Lipitor（阿托伐他汀）和 Crestor（瑞舒伐他汀）。该通讯涉及美国处方信息中妊娠与哺乳相关警语的监管变更和个体化获益/风险判断；它不等于任何个人可以据此自行开始、停止、替换或调整药物。妊娠、疑似妊娠或哺乳相关问题应结合手中产品、目标市场现行说明书和开方团队意见核对。", "en": "On 2021-07-20, FDA issued a class Drug Safety Communication that explicitly lists Lipitor (atorvastatin) and Crestor (rosuvastatin). It concerns U.S. prescribing-information changes around pregnancy and breastfeeding and individualized benefit-risk review; it does not support self-starting, stopping, switching or adjusting any individual medicine. Pregnancy, suspected pregnancy or breastfeeding questions require the exact product, current target-market label and the prescribing team." }, "source": { "id": "src_e5fb970c597c7f50", "label": "FDA：2021-07-20 他汀类药物妊娠与哺乳期药物安全通讯", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/fda-requests-removal-strongest-warning-against-using-cholesterol-lowering-statins-during-pregnancy", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-2023-statin-myasthenia-gravis-rosuvastatin", "issuedAt": "2023-02-06", "status": "ema_prac_product_information_signal", "title": { "zh": "EMA PRAC 产品信息安全信号：Crestor（rosuvastatin）所在他汀类与重症肌无力／眼肌型重症肌无力", "en": "EMA PRAC product-information signal: statins including Crestor (rosuvastatin) and myasthenia gravis / ocular myasthenia" }, "summary": { "zh": "EMA 药物警戒风险评估委员会（PRAC）于 2023-02-06 发布的产品信息措辞摘录，把 Crestor（rosuvastatin）列入他汀类范围。该文件说明：少数报告提示，他汀类可诱发新发或加重既有重症肌无力或眼肌型重症肌无力；同一种或不同他汀再次使用后也报告过症状复发。它是欧盟产品信息更新的、特定日期的信号沟通，不表示手中任何 Crestor 包装、其他市场或任何个人已发生该问题，也不能据此自行停药、换药、减量、加量或交替服用。出现新的或加重的肌无力相关疑问，应带上实际包装和完整用药清单尽快联系开方团队或药师；紧急症状应使用当地急救服务。", "en": "In its product-information wording extract dated 2023-02-06, EMA's Pharmacovigilance Risk Assessment Committee (PRAC) includes Crestor (rosuvastatin) within the statin class. The document says that, in a few reported cases, statins may induce new-onset or aggravate pre-existing myasthenia gravis or ocular myasthenia, and that recurrence after re-administration of the same or a different statin has been reported. This is a dated EU product-information signal; it does not mean that any Crestor pack, another market, or any individual has this problem, and it does not support self-stopping, switching, reducing, increasing, or alternating treatment. New or worsening muscle-weakness questions need the actual pack and complete medicine list reviewed promptly by the prescribing team or pharmacist; emergencies require local emergency services." }, "source": { "id": "src_0fd36b48b08adb04", "label": "EMA PRAC：2023-02-06 他汀类（含 atorvastatin、rosuvastatin）与重症肌无力产品信息安全信号", "url": "https://www.ema.europa.eu/en/documents/prac-recommendation/new-product-information-wording-extracts-prac-recommendations-signals-adopted-9-12-january-2023-prac_bg.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "regulatory_product_information_signal", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "美国 DailyMed 的 CRESTOR（rosuvastatin calcium）有日期公开标签列有 5 mg、10 mg、20 mg、40 mg 口服包衣片。本页分别建立四个准确包装面板的品牌、通用名、每片强度、NDC、外观线索和来源核对卡；不把包装数字变成个人片数、他汀之间的转换、联合用药、停用或购买结论。", "history": "FDA 原始 NDA 审评资料记录 NDA 021366；ANDA 079171 批准信记录其所列 CRESTOR® 参比制剂关系。历史资料与当前产品状态须分开核验。本页的 5 mg、10 mg、20 mg、40 mg 面板只对应 DailyMed SPL v14 所列的具体美国包装，不能延伸为任何其他市场、OD 口崩片、其他包装或当前库存结论。", "sourceDocuments": [ { "id": "src_fe1f4e0e8fa117d2", "label": "DailyMed（NLM）：CRESTOR 瑞舒伐他汀当前美国公开标签（AstraZeneca；SPL v14，2026-05-13 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=325a5d0e-9a72-4015-9fcd-1655fb504cee", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_4f777b38d4dbbdd4", "label": "FDA：CRESTOR 2024-07 标签档案", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/021366s046lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_488f0af36bb0c4c7", "label": "FDA：ANDA 079171 批准信", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/079171Orig1s000ltr.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "approval_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_84cd60c2c43a17d6", "label": "FDA Drugs@FDA", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/about-drugsfda", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "regulatory_reference", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_eb05083a584bc9be", "label": "PMDA：クレストール錠 2.5 mg／5 mg及 OD 錠 2.5 mg／5 mg 当前产品页", "url": "https://www.pmda.go.jp/PmdaSearch/rdDetail/iyaku/2189017F1022_1?user=1", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_74aa269ebb2ff692", "label": "阿斯利康中国：心血管、肾脏及代谢主要产品——可定®（瑞舒伐他汀钙片）5 mg／10 mg／20 mg（2026-08-30 复核）", "url": "https://www.astrazeneca.com.cn/zh/our-focus-areas/cvm.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "first_party_product_page", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" } ], "applicationNumber": "NDA 021366", "approvalTimeline": [ { "date": "2003", "title": { "zh": "FDA 原始 NDA 审评资料入口", "en": "FDA original NDA review entry point" }, "detail": { "zh": "FDA 公开审评资料记录 CRESTOR® 与 NDA 021366。该资料用于历史追溯，不能替代当前标签。", "en": "FDA public review material records CRESTOR® and NDA 021366. It is for historical traceability and does not replace the current label." }, "source": { "id": "src_8a621727628e5103", "label": "FDA: CRESTOR original NDA review", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/21-366_Crestor_Admindocs_P2.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "approval_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, { "date": "2016", "title": { "zh": "ANDA 批准信所列参比制剂关系", "en": "Reference-drug relationship in an ANDA approval letter" }, "detail": { "zh": "FDA ANDA 079171 批准信记录其所列的 CRESTOR® 参比制剂关系。它不自动延伸为其他国家、剂型或产品的替代结论。", "en": "FDA ANDA 079171 records the CRESTOR® reference-drug relationship stated in that letter. It does not automatically extend to other countries, dosage forms or products." }, "source": { "id": "src_488f0af36bb0c4c7", "label": "FDA: ANDA 079171 approval letter", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/079171Orig1s000ltr.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "approval_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, { "date": "2026-05-13", "title": { "zh": "当前 DailyMed SPL v14 公开", "en": "Current DailyMed SPL v14 published" }, "detail": { "zh": "DailyMed 将当前 CRESTOR SPL v14 的发布日期列为 2026-05-13；目标市场、实际供应和个人用药仍须独立核对。", "en": "DailyMed lists 13 May 2026 as the published date for current CRESTOR SPL v14; target-market status, actual supply and individual use still require separate review." }, "source": { "id": "src_fe1f4e0e8fa117d2", "label": "DailyMed: current CRESTOR U.S. public label, SPL v14", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=325a5d0e-9a72-4015-9fcd-1655fb504cee", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, { "date": "2026-08-30", "title": { "zh": "阿斯利康中国当前产品组合页完成复核", "en": "Current AstraZeneca China product-portfolio page reviewed" }, "detail": { "zh": "阿斯利康中国当前心血管、肾脏及代谢主要产品页列示可定®（瑞舒伐他汀钙片）5 mg、10 mg、20 mg。该节点只建立企业当前公开的品牌、通用名与规格线索；不等于 NMPA 批准记录、批准文号、现行说明书、准确包装、库存或可售资格。", "en": "AstraZeneca China's current cardiovascular, renal and metabolic product page lists CRESTOR (可定®), rosuvastatin calcium tablets, in 5 mg, 10 mg and 20 mg strengths. This node establishes only the brand, generic-name and strength cues currently published by the company; it is not an NMPA approval record, approval number, current leaflet, exact package, stock or sale-eligibility record." }, "source": { "id": "src_74aa269ebb2ff692", "label": "AstraZeneca China: current cardiovascular, renal and metabolic product portfolio — CRESTOR / 可定 5 mg, 10 mg and 20 mg (reviewed 30 Aug 2026)", "url": "https://www.astrazeneca.com.cn/zh/our-focus-areas/cvm.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "first_party_product_page", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "已链接公开档案", "en": "Public archive linked" }, "detail": { "zh": "含 NDA 审评、ANDA 批准信及标签档案。", "en": "Includes the NDA review, an ANDA letter and a label archive." } }, { "market": { "zh": "中国大陆", "en": "Mainland China" }, "status": { "zh": "已链接阿斯利康中国当前产品组合页；监管记录仍待逐项核验", "en": "Current AstraZeneca China product-portfolio page linked; regulatory record still requires item-by-item verification" }, "detail": { "zh": "企业当前页面列示可定®（瑞舒伐他汀钙片）5 mg、10 mg、20 mg。页面未在本档案中建立批准文号、现行说明书、包装、库存或可售资格，不能与美国 40 mg 或日本 2.5 mg／OD 片混写。", "en": "The current company page lists CRESTOR (可定®), rosuvastatin calcium tablets, in 5 mg, 10 mg and 20 mg strengths. This dossier has not established an approval number, current leaflet, packaging, stock or sale eligibility from that page, and the record must not be merged with the U.S. 40 mg tablet or Japanese 2.5 mg/OD products." } }, { "market": { "zh": "欧盟", "en": "European Union" }, "status": { "zh": "待建立市场记录", "en": "Market record not established" }, "detail": { "zh": "不能从美国、日本或中国企业页面外推欧盟批准、持有人、规格、说明书、供应或可售资格。", "en": "No EU approval, holder, strength, leaflet, supply or sale-eligibility conclusion is inferred from U.S., Japanese or Chinese company pages." } }, { "market": { "zh": "日本", "en": "Japan" }, "status": { "zh": "已链接 PMDA 当前产品页", "en": "Current PMDA product page linked" }, "detail": { "zh": "PMDA 当前页列示 2.5 mg、5 mg 普通片和 OD 口崩片；仅适用于该日本监管页面所列产品。", "en": "The current PMDA page lists 2.5 mg and 5 mg conventional and OD tablets; this applies only to the products on that Japanese regulatory page." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "一天吃瑞舒伐他汀、一天吃阿托伐他汀，可以隔天轮换吗？", "en": "Can rosuvastatin and atorvastatin be alternated on different days?" }, "answer": { "zh": "不要自行隔天轮换，也不要同日叠加。共同的他汀类别并不建立 mg 换算、交替服用或直接替换关系；轮换还可能掩盖漏服、重复、相互作用和症状来源。请让开方团队或药师用两盒实际药品、处方、完整药单、既往反应和目标市场现行标签确认方案。", "en": "Do not self-alternate them by day or combine them on the same day. A shared statin class does not establish milligram conversion, alternating use or direct substitution, and rotation can obscure missed or duplicate use, interactions and the source of symptoms. Ask the prescriber or pharmacist to confirm the plan using both actual packs, the prescription, complete medicine list, prior reactions and current target-market labels." } }, { "question": { "zh": "为什么肾功能或族群信息会让专业人员单独核对 CRESTOR？", "en": "Why can kidney function or population information trigger a separate CRESTOR review?" }, "answer": { "zh": "当前美国 CRESTOR 标签对严重肾功能受损且未透析者以及亚洲患者列有特定的专业使用边界，并把肾功能受损、65 岁及以上、未控制的甲状腺功能减退、某些联用药和较高规格列为肌病风险因素。这些是专业核对线索，不是网页判断某个人一定适合或不适合瑞舒伐他汀、阿托伐他汀的规则；应结合准确产品、处方、检查结果、既往反应和完整药单。", "en": "The current U.S. CRESTOR label sets specific professional-use boundaries for severe renal impairment without haemodialysis and for Asian patients, and identifies renal impairment, age 65 or older, uncontrolled hypothyroidism, certain co-medications and higher dosage as myopathy risk factors. These are professional review cues, not web rules declaring that someone is or is not suited to rosuvastatin or atorvastatin. The exact product, prescription, test results, prior reactions and complete medicine list must be considered together." } }, { "question": { "zh": "标签提到 SLCO1B1，是不是人人都要做全基因筛查？", "en": "The label mentions SLCO1B1. Does everyone need whole-genome screening?" }, "answer": { "zh": "不是。当前标签的药物基因组学部分只报告：在非常小的受试者组（每组 3–5 人）中，携带两个 SLCO1B1 低功能等位基因者曾观察到较高瑞舒伐他汀浓度，而且该多态性对疗效或安全性的影响尚未明确建立。这不能推出人人做全基因筛查，也不能把已有结果直接变成停药、换药或剂量方案；如已有原始报告，应由专业人员结合全部临床资料解释。", "en": "No. The current label's pharmacogenomics section only reports higher rosuvastatin concentrations in very small groups (three to five people per group) with two reduced-function SLCO1B1 alleles, and states that the effect of this polymorphism on efficacy or safety has not been clearly established. That does not mean everyone needs whole-genome screening or turn an existing result directly into a stop, switch or dose plan. A professional should interpret any original report with the full clinical context." } }, { "question": { "zh": "老人同时吃很多药，出现肌肉痛、无力或深色尿时怎么办？", "en": "What should an older adult taking many medicines do about muscle pain, weakness or dark urine?" }, "answer": { "zh": "应及时联系当地医疗专业人员，并带齐实际药盒、处方药、非处方药、保健品、草本及近期用药变化。网页不能判断是否由他汀、相互作用、甲状腺、肾功能或其他原因造成，也不要自行骤停、补服、隔天轮换或换到阿托伐他汀。若症状严重，或伴发热、明显不适、尿色明显变深、行走困难或意识变化，应及时使用当地紧急医疗渠道。", "en": "Contact a local healthcare professional promptly and bring the actual packs, prescriptions, OTC products, supplements, herbs and recent medicine changes. The site cannot determine whether a statin, interaction, thyroid condition, kidney function or another cause is responsible, and it does not support abrupt self-stopping, catch-up use, alternating days or switching to atorvastatin. Severe symptoms, fever, marked malaise, clearly dark urine, difficulty walking or altered awareness needs prompt local urgent care." } }, { "question": { "zh": "能把这一页与另一种他汀直接做优劣排序吗？", "en": "Can this page rank it against another statin?" }, "answer": { "zh": "不能。比较必须先对齐目标市场、标签版本、剂型、规格、研究人群与价格记录口径。", "en": "No. A comparison must first align the market, label version, dosage form, strength, study population and price-record basis." } } ], "relatedMedicineChecks": [ { "target": { "id": "atorvastatin-lipitor", "brand": "Lipitor", "generic": "阿托伐他汀", "canonicalUrls": { "zh": "https://origindrug.com/drugs/atorvastatin-lipitor/", "en": "https://origindrug.com/en/drugs/atorvastatin-lipitor/" } }, "title": { "zh": "与 LIPITOR／阿托伐他汀同在药单上时：不要把同类药当作可互换的两颗药", "en": "When LIPITOR / atorvastatin is on the same list: do not treat same-class medicines as interchangeable tablets" }, "summary": { "zh": "CRESTOR 与 LIPITOR 的公开标签都说明其属于他汀类；这只是药物类别线索，不支持同日各服一颗、隔天轮换、按毫克换算、直接替换或自行加减。请把两种实际药盒、全部处方药、非处方药和补充剂交给药师或开方团队核对；本卡片不判断谁更适合哪一种药，也不建议自行停用、错开时间、替换或调整任何一种药。", "en": "Public CRESTOR and LIPITOR labels identify both medicines as statins. That is a class clue only; it does not support taking one of each on the same day, alternating days, milligram conversion, direct replacement or self-adjustment. Have a pharmacist or prescriber review both actual packs, every prescription medicine, OTC product and supplement; this card does not decide which medicine suits someone or advise self-stopping, time-separation, replacement or adjustment of either medicine." }, "source": { "id": "src_fe1f4e0e8fa117d2", "label": "DailyMed（NLM）：CRESTOR 瑞舒伐他汀当前美国公开标签", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=325a5d0e-9a72-4015-9fcd-1655fb504cee", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "review_complete_medicine_list_no_self_directed_change" } ], "relatedArticleSlugs": [ "originator-vs-generic", "dosage-forms-are-part-of-medicine-identity" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/rosuvastatin-crestor/", "en": "https://origindrug.com/en/drugs/rosuvastatin-crestor/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "advair-diskus", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-17", "status": "published_traceable_archive" }, "names": { "brand": "ADVAIR DISKUS", "generic": "丙酸氟替卡松/沙美特罗", "aliases": [ "fluticasone propionate/salmeterol", "氟替卡松/沙美特罗", "fluticasone propionate", "salmeterol", "salmeterol xinafoate" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": { "value": "舒利迭®", "status": "discovery_cue_requires_target_market_verification", "source": { "id": "src_feba1443d106a6bf", "label": "GSK 中国产品列表：Seretide／舒利迭（沙美特罗替卡松）", "url": "https://www.gsk-china.com/zh-cn/products/product-list/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "first_party_product_page", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" } } }, "identity": { "therapeuticArea": "呼吸系统", "sourceArchiveMarket": "美国公开监管标签档案", "dosageFormClass": "干粉吸入器（DISKUS）；双成分预装泡罩", "dosageFormClassCode": "inhaled_device", "route": "经口吸入", "routeCode": "inhalation", "historicalApprovalEntry": "2000", "archiveSponsorText": "GlaxoSmithKline LLC（美国公开标签所列）" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [ "ADVAIR HFA", "fluticasone propionate salmeterol aerosol", "fluticasone propionate/salmeterol aerosol" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-advair-diskus-100-50-60-blister-ndc-0173-0695-00", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v32（2026-03-30 发布；2026-03 修订）", "en": "DailyMed SPL v32 (published 30 Mar 2026; revised Mar 2026)" }, "dosageForm": { "zh": "ADVAIR DISKUS 双成分干粉吸入器", "en": "ADVAIR DISKUS two-ingredient dry-powder inhaler" }, "route": { "zh": "经口吸入", "en": "oral inhalation" }, "routeCodes": [ "oral_inhalation" ], "productCode": "NDC 0173-0695-00", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_inhalation", "primaryDisplay": { "zh": "100/50 mcg／标签每次吸入；1 个 DISKUS 吸入器（60 个泡罩）", "en": "100/50 mcg per labelled inhalation; one DISKUS inhaler (60 blisters)" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=advair-diskus-spl-graphic-16.jpg&setid=4eeb5f6a-593f-4a9e-9692-adefa2caf8fc&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "丙酸氟替卡松", "en": "fluticasone propionate" }, "value": 100, "unit": "mcg", "basisCode": "per_inhalation", "basisLabel": { "zh": "每次吸入的标签成分标示；不是个人使用指令", "en": "labelled ingredient amount per inhalation; not an individual's use instruction" } }, { "ingredient": { "zh": "沙美特罗", "en": "salmeterol" }, "value": 50, "unit": "mcg", "basisCode": "per_inhalation", "basisLabel": { "zh": "每次吸入的标签成分标示；不是个人使用指令", "en": "labelled ingredient amount per inhalation; not an individual's use instruction" } } ], "concentration": null, "container": { "typeCode": "dry_powder_inhaler", "typeLabel": { "zh": "DISKUS 干粉吸入器", "en": "DISKUS dry-powder inhaler" }, "fill": null, "countPerPackage": 60, "countUnit": { "zh": "泡罩/吸入器", "en": "blisters per inhaler" }, "unitsPerContainer": { "count": 60, "unit": { "zh": "标签吸入", "en": "labelled inhalations" } } }, "deliveryDevice": { "typeCode": "diskus_dry_powder_inhaler", "name": { "zh": "DISKUS 吸入器", "en": "DISKUS inhaler" } }, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-21", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 1, "unit": { "zh": "吸入器/纸盒（60 个泡罩）", "en": "inhaler per carton (60 blisters)" } }, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_c264f3fb8b6629af", "label": "DailyMed（NLM）：ADVAIR DISKUS 当前美国公开标签（GSK；SPL v32，2026-03-30 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=4eeb5f6a-593f-4a9e-9692-adefa2caf8fc&version=32", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-advair-diskus-250-50-60-blister-ndc-0173-0696-00", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v32（2026-03-30 发布；2026-03 修订）", "en": "DailyMed SPL v32 (published 30 Mar 2026; revised Mar 2026)" }, "dosageForm": { "zh": "ADVAIR DISKUS 双成分干粉吸入器", "en": "ADVAIR DISKUS two-ingredient dry-powder inhaler" }, "route": { "zh": "经口吸入", "en": "oral inhalation" }, "routeCodes": [ "oral_inhalation" ], "productCode": "NDC 0173-0696-00", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_inhalation", "primaryDisplay": { "zh": "250/50 mcg／标签每次吸入；1 个 DISKUS 吸入器（60 个泡罩）", "en": "250/50 mcg per labelled inhalation; one DISKUS inhaler (60 blisters)" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=advair-diskus-spl-graphic-17.jpg&setid=4eeb5f6a-593f-4a9e-9692-adefa2caf8fc&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "丙酸氟替卡松", "en": "fluticasone propionate" }, "value": 250, "unit": "mcg", "basisCode": "per_inhalation", "basisLabel": { "zh": "每次吸入的标签成分标示；不是个人使用指令", "en": "labelled ingredient amount per inhalation; not an individual's use instruction" } }, { "ingredient": { "zh": "沙美特罗", "en": "salmeterol" }, "value": 50, "unit": "mcg", "basisCode": "per_inhalation", "basisLabel": { "zh": "每次吸入的标签成分标示；不是个人使用指令", "en": "labelled ingredient amount per inhalation; not an individual's use instruction" } } ], "concentration": null, "container": { "typeCode": "dry_powder_inhaler", "typeLabel": { "zh": "DISKUS 干粉吸入器", "en": "DISKUS dry-powder inhaler" }, "fill": null, "countPerPackage": 60, "countUnit": { "zh": "泡罩/吸入器", "en": "blisters per inhaler" }, "unitsPerContainer": { "count": 60, "unit": { "zh": "标签吸入", "en": "labelled inhalations" } } }, "deliveryDevice": { "typeCode": "diskus_dry_powder_inhaler", "name": { "zh": "DISKUS 吸入器", "en": "DISKUS inhaler" } }, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-21", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 1, "unit": { "zh": "吸入器/纸盒（60 个泡罩）", "en": "inhaler per carton (60 blisters)" } }, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_c264f3fb8b6629af", "label": "DailyMed（NLM）：ADVAIR DISKUS 当前美国公开标签（GSK；SPL v32，2026-03-30 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=4eeb5f6a-593f-4a9e-9692-adefa2caf8fc&version=32", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-advair-diskus-500-50-60-blister-ndc-0173-0697-00", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v32（2026-03-30 发布；2026-03 修订）", "en": "DailyMed SPL v32 (published 30 Mar 2026; revised Mar 2026)" }, "dosageForm": { "zh": "ADVAIR DISKUS 双成分干粉吸入器", "en": "ADVAIR DISKUS two-ingredient dry-powder inhaler" }, "route": { "zh": "经口吸入", "en": "oral inhalation" }, "routeCodes": [ "oral_inhalation" ], "productCode": "NDC 0173-0697-00", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_inhalation", "primaryDisplay": { "zh": "500/50 mcg／标签每次吸入；1 个 DISKUS 吸入器（60 个泡罩）", "en": "500/50 mcg per labelled inhalation; one DISKUS inhaler (60 blisters)" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=advair-diskus-spl-graphic-18.jpg&setid=4eeb5f6a-593f-4a9e-9692-adefa2caf8fc&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "丙酸氟替卡松", "en": "fluticasone propionate" }, "value": 500, "unit": "mcg", "basisCode": "per_inhalation", "basisLabel": { "zh": "每次吸入的标签成分标示；不是个人使用指令", "en": "labelled ingredient amount per inhalation; not an individual's use instruction" } }, { "ingredient": { "zh": "沙美特罗", "en": "salmeterol" }, "value": 50, "unit": "mcg", "basisCode": "per_inhalation", "basisLabel": { "zh": "每次吸入的标签成分标示；不是个人使用指令", "en": "labelled ingredient amount per inhalation; not an individual's use instruction" } } ], "concentration": null, "container": { "typeCode": "dry_powder_inhaler", "typeLabel": { "zh": "DISKUS 干粉吸入器", "en": "DISKUS dry-powder inhaler" }, "fill": null, "countPerPackage": 60, "countUnit": { "zh": "泡罩/吸入器", "en": "blisters per inhaler" }, "unitsPerContainer": { "count": 60, "unit": { "zh": "标签吸入", "en": "labelled inhalations" } } }, "deliveryDevice": { "typeCode": "diskus_dry_powder_inhaler", "name": { "zh": "DISKUS 吸入器", "en": "DISKUS inhaler" } }, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-21", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 1, "unit": { "zh": "吸入器/纸盒（60 个泡罩）", "en": "inhaler per carton (60 blisters)" } }, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_c264f3fb8b6629af", "label": "DailyMed（NLM）：ADVAIR DISKUS 当前美国公开标签（GSK；SPL v32，2026-03-30 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=4eeb5f6a-593f-4a9e-9692-adefa2caf8fc&version=32", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": null, "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=advair-diskus-spl-graphic-16.jpg&setid=4eeb5f6a-593f-4a9e-9692-adefa2caf8fc&type=img", "alt": "ADVAIR DISKUS 丙酸氟替卡松/沙美特罗在美国 DailyMed GSK 公开标签中的 100/50、60 泡罩吸入装置包装图", "archiveMarket": "美国", "labelVersion": "DailyMed 公开标签（GlaxoSmithKline，2026-03 更新）", "presentation": "ADVAIR DISKUS 丙酸氟替卡松/沙美特罗吸入粉剂：100/50、60 泡罩 DISKUS 装置包装图（DailyMed GSK 公开标签所列）。", "notice": "此为美国 DailyMed GSK 公开标签中明确对应 ADVAIR DISKUS、100/50、60 泡罩吸入装置的包装图，只帮助核对品牌、两个成分、标示量、装置、泡罩数量和来源；不用于鉴定真伪，也不证明其他强度、其他装置、其他市场标签、当前可得性、原研身份、目标市场批准或可售资格。", "source": { "id": "src_c264f3fb8b6629af", "label": "DailyMed（NLM）：ADVAIR DISKUS 公开标签（GlaxoSmithKline，2026-03 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=4eeb5f6a-593f-4a9e-9692-adefa2caf8fc&version=32", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "ADVAIR DISKUS 说明书放大阅读：双成分数字与吸入装置必须一起看", "en": "ADVAIR DISKUS label reading: read the two ingredient numbers together with the inhaler device" }, "summary": { "zh": "本模块以美国 DailyMed 2026-03 公开标签为阅读入口，帮助核对 ADVAIR DISKUS、丙酸氟替卡松、沙美特罗、双成分标示、干粉吸入装置和经口吸入途径。它不将包装信息变成个人的吸入次数、加量、替代或急性呼吸处理规则。", "en": "This module uses the March 2026 U.S. DailyMed label as a reading entry point. It helps check ADVAIR DISKUS, fluticasone propionate, salmeterol, the two-ingredient marking, dry-powder inhaler device and oral-inhalation route. It does not turn package information into an individual's inhalation count, escalation, substitution or acute-breathing rule." }, "checks": [ { "zh": "先把商品名、两个成分、每次吸入的完整双数字、DISKUS 干粉装置和目标市场一起核对。不要只看其中一个数字，或把包装标示理解为网页给任何人计算的每日吸入次数。", "en": "Check the brand, both ingredients, the complete two-number marking per inhalation, the DISKUS dry-powder device and target market together. Do not read only one number or treat a package marking as a web-calculated daily inhalation count." }, { "zh": "这份标签把 ADVAIR DISKUS 描述为经口吸入粉剂。名称相似、共同含有一个成分，或都是吸入药，并不能证明另一种气雾剂、雾化液、胶囊吸入剂或不同装置可以自行替换。", "en": "This label describes ADVAIR DISKUS as an oral-inhalation powder. A similar name, one shared ingredient or the fact that both are inhalers does not establish that another aerosol, nebulised solution, inhalation capsule or device can be self-substituted." }, { "zh": "标签把维持治疗与突发气道痉挛的即时缓解区分开来。突发或加重的呼吸困难、咳嗽或喘鸣，应按当地紧急医疗服务和已有照护计划及时处理，而不是根据网页自行连续补吸、叠加装置或借用他人药品。", "en": "The label distinguishes maintenance treatment from immediate relief of acute bronchospasm. Sudden or worsening breathing difficulty, cough or wheeze needs timely action through local emergency services and an existing care plan, not repeated self-use, device stacking or borrowing another person's medicine from a webpage." }, { "zh": "所有正在使用的吸入药、处方药、非处方药、补充剂和草本都应随实际装置一起交给药师或医生核对。复方中的一个成分相同，不表示两种产品可以自行叠加、交替或替换。", "en": "All current inhalers, prescription medicines, OTC products, supplements and herbs should be reviewed with the actual device by a pharmacist or clinician. Sharing one ingredient in a combination product does not mean two products can be self-combined, alternated or substituted." } ], "source": { "id": "src_c264f3fb8b6629af", "label": "DailyMed（NLM）：ADVAIR DISKUS 公开标签（GSK，2026-03 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=4eeb5f6a-593f-4a9e-9692-adefa2caf8fc&version=32", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "丙酸氟替卡松/沙美特罗怎样起作用：标签描述两个不同类别成分的组合", "en": "How fluticasone propionate/salmeterol works: the label describes a combination of two medicine classes" }, "summary": { "zh": "这份公开标签将该产品描述为含皮质激素成分与长效 β2 受体激动剂成分的复方。机制只解释成分角色，不决定某个人应使用哪种装置、何时使用、是否能合用或是否适合转换。", "en": "The public label describes this as a combination of a corticosteroid ingredient and a long-acting beta2-agonist ingredient. Mechanism explains ingredient roles; it does not decide which device a person should use, when to use it, whether products can be combined or whether a switch is suitable." }, "checks": [ { "zh": "复方含有两个作用路径，不等于可以把任一成分单独拆出来与另一装置的相似成分相加。机制名称和共同成分都不是自行合并或替换的依据。", "en": "A combination has two action pathways; that does not permit separating one ingredient and adding it to a similar ingredient in another device. Mechanism names and shared ingredients are not a basis for self-combination or substitution." }, { "zh": "标签对含长效 β2 受体激动剂的联用另列使用边界。任何新增吸入器、心血管药、利尿剂、抗抑郁药或补充剂，均应连同准确产品和完整药单交由专业人员复核。", "en": "The label separately sets boundaries for co-use involving long-acting beta2-agonists. Any new inhaler, cardiovascular medicine, diuretic, antidepressant or supplement needs review of the exact product and complete medicine list by a professional." }, { "zh": "理解“一个抗炎成分加一个支气管舒张成分”有助于读标签，但不能把机制写成个人疗效承诺、急性症状处理方案或产品之间的等量换算公式。", "en": "Understanding “an anti-inflammatory ingredient plus a bronchodilator ingredient” can help read a label, but does not turn mechanism into a personal efficacy promise, an acute-symptom plan or an equal-conversion formula between products." } ], "source": { "id": "src_c264f3fb8b6629af", "label": "DailyMed（NLM）：ADVAIR DISKUS 公开标签（GSK，2026-03 更新；临床药理/相互作用）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=4eeb5f6a-593f-4a9e-9692-adefa2caf8fc&version=32", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "ADVAIR DISKUS", "generic": "丙酸氟替卡松/沙美特罗", "dosageFormClass": "干粉吸入器（DISKUS）；双成分预装泡罩" }, "labelSource": { "id": "src_c264f3fb8b6629af", "label": "DailyMed（NLM）：ADVAIR DISKUS 公开标签（GSK，2026-03 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=4eeb5f6a-593f-4a9e-9692-adefa2caf8fc&version=32", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "productRoutes": [ { "source": { "id": "src_c264f3fb8b6629af", "label": "DailyMed（NLM）：ADVAIR DISKUS 公开标签（GSK，2026-03 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=4eeb5f6a-593f-4a9e-9692-adefa2caf8fc&version=32", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "美国 DailyMed 2026-03 标签将 ADVAIR DISKUS 列为经口吸入的丙酸氟替卡松/沙美特罗复方干粉吸入器，初始美国批准年份为 2000。此页只帮助把两个成分、每次吸入的双数字、DISKUS 装置和目标市场标签放在一起阅读；不提供个人吸入次数、急性症状处理、换药或联用方案。", "history": "同一品牌、相似的双数字、相同的一个成分或一张包装照片，都不足以证明可与另一种吸入器、另一强度或另一市场产品互换。该档案的官方来源明确将产品呈现为经口吸入粉剂，并分别展示 100/50、250/50、500/50 三个 60 泡罩 DISKUS 包装面板。", "sourceDocuments": [ { "id": "src_c264f3fb8b6629af", "label": "DailyMed（NLM）：ADVAIR DISKUS 公开标签（GSK，2026-03 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=4eeb5f6a-593f-4a9e-9692-adefa2caf8fc&version=32", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_5ed30b676fbb9773", "label": "FDA Drugs@FDA 官方检索入口", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_lookup_entry", "documentKind": "regulatory_lookup", "market": "US", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } ], "applicationNumber": "NDA 021077", "approvalTimeline": [ { "date": "2000", "title": { "zh": "FDA 标签所列美国初始批准年份", "en": "Initial U.S. approval year listed in the FDA label" }, "detail": { "zh": "本页链接的 FDA 标签档案列示 Initial U.S. Approval: 2000。该历史定位不等同于当前批准、可得性、持有人或其他市场状态。", "en": "The FDA label archive linked here lists Initial U.S. Approval: 2000. This historical locator is not a conclusion about current approval, availability, holder or another market." }, "source": { "id": "src_c264f3fb8b6629af", "label": "DailyMed: ADVAIR DISKUS public label archive", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=4eeb5f6a-593f-4a9e-9692-adefa2caf8fc&version=32", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, { "date": "2026-03", "title": { "zh": "FDA 标签档案版本", "en": "FDA label archive version" }, "detail": { "zh": "本页链接 2026-03 的 FDA 标签档案作为可复核阅读入口。现行标签、规格、适应症和安全信息必须另行以目标市场当前文件核对。", "en": "This page links the 2026-03 FDA label archive as a traceable reading entry point. Current labeling, strength, indication and safety information require separate verification against the target market’s current document." }, "source": { "id": "src_c264f3fb8b6629af", "label": "DailyMed: ADVAIR DISKUS public label archive", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=4eeb5f6a-593f-4a9e-9692-adefa2caf8fc&version=32", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "已链接公开标签档案", "en": "Public label archive linked" }, "detail": { "zh": "仅对应本页所列 FDA 文件。", "en": "Only the FDA document listed on this page is linked." } }, { "market": { "zh": "中国大陆、欧盟、日本", "en": "Mainland China, EU, Japan" }, "status": { "zh": "待逐项建立市场记录", "en": "Market record not established" }, "detail": { "zh": "不从美国标签档案推定当地批准、持有人、规格、供应或可售资格。", "en": "No local approval, holder, strength, supply or sale-eligibility conclusion is inferred from the U.S. label archive." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "标签档案能代表现在的产品信息吗？", "en": "Does a label archive represent current product information?" }, "answer": { "zh": "不能自动代表。档案用于定位来源；需要以目标市场的现行官方标签逐项复核。", "en": "Not automatically. The archive locates a source; each point needs verification against the target market’s current official label." } }, { "question": { "zh": "为什么这里不展示价格或原研/仿制结论？", "en": "Why are price and originator/generic conclusions not shown?" }, "answer": { "zh": "这些结论需要产品、剂型、规格、包装、市场、日期和原始记录分别齐全并经人工审核；单一标签文件不足以支持。", "en": "Those conclusions require separately complete and human-reviewed product, dosage-form, strength, pack, market, date and primary-record fields; one label file is insufficient." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "how-to-read-a-drug-label", "regulatory-sources-first" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/advair-diskus/", "en": "https://origindrug.com/en/drugs/advair-diskus/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "bayer-low-dose-aspirin", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-30", "status": "published_traceable_archive" }, "names": { "brand": "BAYER LOW DOSE ASPIRIN", "generic": "阿司匹林", "aliases": [ "Bayer Aspirin", "Aspirin Regimen", "BAYER ASPIRIN", "拜阿司匹灵", "拜阿司匹灵肠溶片", "aspirin", "acetylsalicylic acid", "ASA" ], "marketBrandNames": [ { "name": "拜阿司匹灵®", "market": { "zh": "中国大陆（拜耳中国 2024 年有日期品牌/包装资料）", "en": "Mainland China (dated Bayer China 2024 brand/package material)" }, "evidenceStatus": "dated_public_record", "note": { "zh": "拜耳中国资料把拜阿司匹灵®列为中国大陆 100 mg 阿司匹林肠溶片，并介绍 30 片与 90 片包装。本档案主体是美国每片 81 mg 的 BAYER LOW DOSE ASPIRIN；两个市场的强度、包装和标签不能因品牌关联或都写“低剂量/阿司匹林”而合并为同一产品。", "en": "Bayer China material identifies Bayer Aspirin® in Mainland China as a 100 mg enteric-coated aspirin tablet and describes 30- and 90-tablet packs. This dossier is the U.S. 81 mg-per-tablet BAYER LOW DOSE ASPIRIN product; the strengths, packages and labels in the two markets must not be merged as one product because of a related brand or shared 'low dose/aspirin' wording." }, "source": { "id": "src_9cce1cc5fe0337c1", "label": "拜耳中国：拜阿司匹灵® 100 mg 阿司匹林肠溶片全新包装上市（2024）", "url": "https://www.bayer.com.cn/zh-hans/baiasipilingquanxinbaozhuangshangshi", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "first_party_release", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" } } ], "mainlandChinaTradeNameCue": { "value": "拜阿司匹灵®", "status": "discovery_cue_requires_target_market_verification", "source": { "id": "src_9cce1cc5fe0337c1", "label": "拜耳中国：拜阿司匹灵® 100 mg 阿司匹林肠溶片全新包装上市（2024）", "url": "https://www.bayer.com.cn/zh-hans/baiasipilingquanxinbaozhuangshangshi", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "first_party_release", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" } } }, "identity": { "therapeuticArea": "疼痛与炎症", "sourceArchiveMarket": "美国 DailyMed 81 mg OTC 公开标签；中国大陆拜耳中国 2024 年 100 mg、30/90 片有日期品牌包装资料（不是现行批准说明书）", "dosageFormClass": "肠溶包衣口服片；美国资料每片 81 mg，中国大陆有日期品牌资料每片 100 mg", "dosageFormClassCode": "oral_modified_release", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "未在本页推定（应按目标市场官方记录核验）", "archiveSponsorText": "Bayer HealthCare LLC（美国公开标签所列）" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-bayer-low-dose-aspirin-enteric-tablet-81mg-200ct-ndc-0280-2100-20", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v8；标签生效 2025-12-04，发布 2025-12-05", "en": "DailyMed SPL v8; label effective 4 Dec 2025, published 5 Dec 2025" }, "dosageForm": { "zh": "BAYER LOW DOSE ASPIRIN 肠溶包衣口服片", "en": "BAYER LOW DOSE ASPIRIN enteric-coated oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 0280-2100-20", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片阿司匹林 81 mg；200 片瓶装纸盒", "en": "Aspirin 81 mg per enteric-coated tablet; 200-tablet bottle carton" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=Bayer+Low+Aspirin_200ct_Ctn.jpg&setid=075b103e-0bb4-4b7a-ac0e-5645bcbd0a07&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "阿司匹林", "en": "aspirin" }, "value": 81, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签含量；不是个人服用片数", "en": "labelled amount per tablet/caplet; not an individual's tablet count" } } ], "concentration": null, "container": { "typeCode": "bottle_carton", "typeLabel": { "zh": "200 片瓶装纸盒", "en": "200-tablet bottle carton" }, "fill": null, "countPerPackage": 200, "countUnit": { "zh": "片/瓶装纸盒", "en": "tablets per bottle carton" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-19", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 200, "unit": { "zh": "片/瓶装纸盒", "en": "tablets per bottle carton" } }, "physicalClues": { "color": { "zh": "橙色与白色纸盒展示面", "en": "orange-and-white carton display panel" }, "shape": { "zh": "肠溶包衣片", "en": "enteric-coated tablet" }, "imprint": null, "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_3c1cad1341a17717", "label": "DailyMed（NLM）：BAYER LOW DOSE ASPIRIN 当前美国 OTC 公开标签（Bayer HealthCare；SPL v8，2025-12-05 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=075b103e-0bb4-4b7a-ac0e-5645bcbd0a07&version=8", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "cn-bayer-aspirin-enteric-tablet-100mg-30-tablet-dated-pack-record", "marketCode": "CN", "labelVersion": { "zh": "拜耳中国有日期品牌包装资料，2024-11-06；不是现行批准说明书", "en": "Dated Bayer China brand/package material, 6 Nov 2024; not a current approved leaflet" }, "dosageForm": { "zh": "拜阿司匹灵® 阿司匹林肠溶片", "en": "Bayer Aspirin® enteric-coated aspirin tablet" }, "route": { "zh": "口服（品牌包装资料中的产品身份字段）", "en": "oral (product-identity field in dated brand/package material)" }, "routeCodes": [ "oral" ], "productCode": "Bayer China dated pack record: 30 tablets", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片阿司匹林 100 mg；30 片/盒（2024 年品牌包装资料）", "en": "Aspirin 100 mg per tablet; 30 tablets per carton (2024 brand/package material)" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "阿司匹林", "en": "aspirin" }, "value": 100, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片公开资料标示量；不是个人每日片数、加量、换算或换药规则", "en": "labelled amount per tablet in the public material; not an individual's daily tablet count, escalation, conversion or switching rule" } } ], "concentration": null, "container": { "typeCode": "carton", "typeLabel": { "zh": "纸盒", "en": "carton" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "片/盒", "en": "tablets per carton" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-30", "currentLabelDisplayed": false, "ndcDirectoryListed": false, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 30, "unit": { "zh": "片/盒", "en": "tablets per carton" } }, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_9cce1cc5fe0337c1", "label": "拜耳中国：拜阿司匹灵® 100 mg、30/90 片新包装公开资料（2024-11-06）", "url": "https://www.bayer.com.cn/zh-hans/baiasipilingquanxinbaozhuangshangshi", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "first_party_release", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "cn-bayer-aspirin-enteric-tablet-100mg-90-tablet-dated-pack-record", "marketCode": "CN", "labelVersion": { "zh": "拜耳中国有日期品牌包装资料，2024-11-06；不是现行批准说明书", "en": "Dated Bayer China brand/package material, 6 Nov 2024; not a current approved leaflet" }, "dosageForm": { "zh": "拜阿司匹灵® 阿司匹林肠溶片", "en": "Bayer Aspirin® enteric-coated aspirin tablet" }, "route": { "zh": "口服（品牌包装资料中的产品身份字段）", "en": "oral (product-identity field in dated brand/package material)" }, "routeCodes": [ "oral" ], "productCode": "Bayer China dated pack record: 90 tablets", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片阿司匹林 100 mg；90 片/盒（2024 年品牌包装资料）", "en": "Aspirin 100 mg per tablet; 90 tablets per carton (2024 brand/package material)" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "阿司匹林", "en": "aspirin" }, "value": 100, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片公开资料标示量；不是个人每日片数、疗程、加量、换算或换药规则", "en": "labelled amount per tablet in the public material; not an individual's daily tablet count, duration, escalation, conversion or switching rule" } } ], "concentration": null, "container": { "typeCode": "carton", "typeLabel": { "zh": "纸盒", "en": "carton" }, "fill": null, "countPerPackage": 90, "countUnit": { "zh": "片/盒", "en": "tablets per carton" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-30", "currentLabelDisplayed": false, "ndcDirectoryListed": false, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 90, "unit": { "zh": "片/盒", "en": "tablets per carton" } }, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_9cce1cc5fe0337c1", "label": "拜耳中国：拜阿司匹灵® 100 mg、30/90 片新包装公开资料（2024-11-06）", "url": "https://www.bayer.com.cn/zh-hans/baiasipilingquanxinbaozhuangshangshi", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "first_party_release", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-bayer-low-dose-aspirin-enteric-tablet-81mg-200ct-ndc-0280-2100-20", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=Bayer+Low+Aspirin_200ct_Ctn.jpg&setid=075b103e-0bb4-4b7a-ac0e-5645bcbd0a07&type=img", "alt": "BAYER LOW DOSE ASPIRIN 阿司匹林在美国 DailyMed Bayer 公开标签中的 81 mg、200 片装纸盒图", "archiveMarket": "美国", "labelVersion": "DailyMed 公开标签（Bayer HealthCare，2025-12 更新）", "presentation": "BAYER LOW DOSE ASPIRIN：每片阿司匹林 81 mg、肠溶包衣片、200 片装纸盒图（DailyMed Bayer HealthCare 公开标签所列）。", "notice": "此为美国 DailyMed Bayer HealthCare 公开标签中对应 BAYER LOW DOSE ASPIRIN、每片阿司匹林 81 mg、肠溶包衣片和 200 片装的纸盒图，只帮助核对品牌、通用名、标示强度、剂型、包装数量和来源；不用于鉴定真伪，也不证明其他包装、其他市场标签、当前可得性、原研身份、目标市场批准、心血管用途或可售资格。", "source": { "id": "src_3c1cad1341a17717", "label": "DailyMed（NLM）：BAYER LOW DOSE ASPIRIN 公开标签（Bayer HealthCare，2025-12 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=075b103e-0bb4-4b7a-ac0e-5645bcbd0a07&version=8", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "阿司匹林说明书放大阅读：先分清美国 81 mg 与中国大陆 100 mg 包装", "en": "Aspirin label reading: separate the U.S. 81 mg label from the Mainland-China 100 mg packs first" }, "summary": { "zh": "本模块以美国 DailyMed 2025-12 公开标签为警示信息入口，并把拜耳中国 2024 年 100 mg、30/90 片品牌包装资料作为独立的中国大陆身份线索。81 mg 与 100 mg 都是每片标示量，不是网页给出的每日片数；中国品牌新闻也不替代现行批准说明书。", "en": "This module uses the December 2025 U.S. DailyMed public label for warning information and keeps Bayer China's dated 2024 material for the 100 mg, 30/90-tablet packs as a separate Mainland-China identity cue. Both 81 mg and 100 mg are labelled amounts per tablet, not web-given daily tablet counts; a China brand announcement is not a substitute for a current approved leaflet." }, "checks": [ { "zh": "先把市场、商品名、阿司匹林、每片标示量、肠溶剂型和实际包装一起核对。美国资料为每片 81 mg；中国大陆有日期品牌资料为每片 100 mg、30 或 90 片。81 mg 和 100 mg 都不是个人每日片数，不能因数字接近而自行换算、补片、隔天轮换或替换。", "en": "Check the market, brand, aspirin, labelled amount per tablet, enteric-coated form and actual pack together. The U.S. material is 81 mg per tablet; the dated Mainland-China brand material is 100 mg per tablet in 30- or 90-tablet packs. Neither number is an individual's daily tablet count, and their similarity does not permit self-conversion, extra tablets, alternate-day rotation or substitution." }, { "zh": "标签说明这一肠溶包衣产品起效延后，不能据此推导为“更强”“适合所有心脏问题”或可用于需要快速缓解的症状。不要因“阿司匹林”“低剂量”或包装颜色相似而自行添加、隔天轮换、替换抗血小板、抗凝或止痛产品。", "en": "The label notes delayed action for this enteric-coated product; that does not mean “stronger,” suitable for every heart concern, or appropriate for symptoms needing rapid relief. Do not self-add, alternate or substitute an antiplatelet, anticoagulant or pain product because of the words “aspirin,” “low dose” or similar package colours." }, { "zh": "该标签提示胃出血风险在 60 岁及以上、有胃溃疡或出血问题、合用抗凝药或激素药、合用其他含 NSAID 产品、每日大量饮酒等情形中需要特别核对。请把所有处方药、非处方止痛/感冒药、草本、补充剂和实际药盒一起交给药师或医生；网页不能把这些提示变成个人的“能用/不能用”结论。", "en": "The label flags stomach-bleeding questions especially for people age 60 or older, those with ulcer or bleeding history, people using an anticoagulant or steroid, other NSAID-containing products, or substantial daily alcohol. Bring all prescriptions, OTC pain/cold products, herbs, supplements and actual packs to a pharmacist or clinician; a webpage cannot turn these warnings into an individual's “can/cannot use” conclusion." }, { "zh": "出现呕血、黑便或血便、晕厥、面部或咽喉肿胀、喘鸣、休克样表现或其他急性严重不适时，应优先使用当地紧急医疗支持；不要等待网页检索或自行用另一种药抵消。", "en": "With vomiting blood, black or bloody stools, fainting, facial or throat swelling, wheeze, shock-like symptoms or another acute severe problem, prioritise local emergency medical support; do not wait for a website search or self-counteract with another medicine." } ], "source": { "id": "src_3c1cad1341a17717", "label": "DailyMed（NLM）：BAYER LOW DOSE ASPIRIN 公开标签（Bayer HealthCare，2025-12 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=075b103e-0bb4-4b7a-ac0e-5645bcbd0a07&version=8", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "阿司匹林怎样起作用：先把 NSAID 标签分类和个人用药决定分开", "en": "How aspirin works: keep the NSAID label category separate from individual-use decisions" }, "summary": { "zh": "该美国 DailyMed 标签将每片 81 mg 的阿司匹林标示为 NSAID。这个分类可帮助读者识别标签中为何出现胃出血、过敏和与其他 NSAID 同用的警示；它不用于判断一个人是否应使用阿司匹林、适合哪一种产品、能否与抗血小板或抗凝药合用，或怎样调整。", "en": "This U.S. DailyMed label identifies its 81 mg aspirin tablet as an NSAID. That category can help a reader understand why the label includes stomach-bleeding, allergy and other-NSAID warnings; it does not determine whether a person should use aspirin, which product is suitable, whether it can be combined with an antiplatelet or anticoagulant, or how to adjust it." }, "checks": [ { "zh": "“NSAID”是标签上的药物类别线索，不是把所有止痛、退热、抗血小板或抗凝产品归为可以互换或联合的依据。不同活性成分、剂型、目标市场标签和个人情况都需要分别核对。", "en": "“NSAID” is a label category clue, not a basis to treat all pain, fever, antiplatelet or anticoagulant products as interchangeable or combinable. Active ingredient, dosage form, target-market label and individual context all need separate review." }, { "zh": "肠溶包衣描述的是这一准确片剂的制剂特征。它不自动消除出血、过敏或相互作用风险，也不表示可以掰开、研碎、改用不同强度或在有症状时自行加用另一种产品。", "en": "Enteric coating describes a formulation feature of this exact tablet. It does not automatically remove bleeding, allergy or interaction risk, or mean that the tablet may be split, crushed, replaced by another strength or supplemented with another product when symptoms occur." }, { "zh": "理解标签分类最有用的下一步是让药师或医生用完整药单和现行标签核对风险，而不是根据机制词、包装文字或网络经验自行开始、停用、叠加或替换。", "en": "The most useful next step after understanding a label category is to have a pharmacist or clinician check risk using the full medicine list and current label—not to self-start, stop, combine or substitute from a mechanism word, package wording or online experience." } ], "source": { "id": "src_3c1cad1341a17717", "label": "DailyMed（NLM）：BAYER LOW DOSE ASPIRIN 公开标签（Bayer HealthCare，2025-12 更新；Drug Facts）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=075b103e-0bb4-4b7a-ac0e-5645bcbd0a07&version=8", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "BAYER LOW DOSE ASPIRIN", "generic": "阿司匹林", "dosageFormClass": "肠溶包衣口服片；美国资料每片 81 mg，中国大陆有日期品牌资料每片 100 mg" }, "labelSource": { "id": "src_3c1cad1341a17717", "label": "DailyMed（NLM）：BAYER LOW DOSE ASPIRIN 公开标签（Bayer HealthCare，2025-12 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=075b103e-0bb4-4b7a-ac0e-5645bcbd0a07&version=8", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "productRoutes": [ { "source": { "id": "src_3c1cad1341a17717", "label": "DailyMed（NLM）：BAYER LOW DOSE ASPIRIN 公开标签（Bayer HealthCare，2025-12 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=075b103e-0bb4-4b7a-ac0e-5645bcbd0a07&version=8", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "美国 DailyMed 2025-12 BAYER LOW DOSE 标签列为每片阿司匹林 81 mg 的肠溶包衣口服片；拜耳中国 2024 年有日期公开资料把拜阿司匹灵®列为每片 100 mg 的阿司匹林肠溶片，并列出 30 片与 90 片包装。此页帮助把市场、商品名、每片毫克数、剂型和实际包装一起阅读；不把 81 mg 或 100 mg 换算成个人片数，也不判断任何人是否需要阿司匹林、怎样联用或是否应停用。", "history": "本页把美国当前 OTC 标签与中国大陆有日期品牌包装资料分开保存。中国大陆公开资料可证明 2024 年发布时的 100 mg、30/90 片包装线索，但不是现行批准说明书，不能据此推定当前批准文号、完整用法、供应或可售状态。‘低剂量’‘肠溶/安全包衣’和相似包装均不能跨市场推导可替代性或个人方案；多种影响出血的药物同时使用时，应由药师或医生核对完整药单。", "sourceDocuments": [ { "id": "src_3c1cad1341a17717", "label": "DailyMed（NLM）：BAYER LOW DOSE ASPIRIN 公开标签（Bayer HealthCare，2025-12 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=075b103e-0bb4-4b7a-ac0e-5645bcbd0a07&version=8", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_9cce1cc5fe0337c1", "label": "拜耳中国：拜阿司匹灵® 100 mg、30/90 片新包装公开资料（2024-11-06）", "url": "https://www.bayer.com.cn/zh-hans/baiasipilingquanxinbaozhuangshangshi", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "first_party_release", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, { "id": "src_f6ae0e06d563a6a2", "label": "FDA：药物相互作用消费者信息", "url": "https://www.fda.gov/drugs/resources-drugs/drug-interactions-what-you-should-know", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "public_health_reference", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } ], "applicationNumber": "DailyMed U.S. OTC label record", "approvalTimeline": [ { "date": "2025-12", "title": { "zh": "DailyMed 公开标签版本", "en": "DailyMed public label version" }, "detail": { "zh": "本页链接 2025-12 的 DailyMed 美国 OTC 公开标签作为可复核阅读入口。它标识该具体公开标签，不推定初始批准年份、NDA 编号、当前供应、持有人或其他市场状态。", "en": "This page links the 2025-12 DailyMed U.S. OTC public label as a traceable reading entry point. It identifies that specific public label and does not assert an original-approval year, NDA number, current availability, holder or another-market status." }, "source": { "id": "src_3c1cad1341a17717", "label": "DailyMed: BAYER LOW DOSE aspirin public OTC label", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=075b103e-0bb4-4b7a-ac0e-5645bcbd0a07&version=8", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "已链接 OTC 公开标签", "en": "OTC public label linked" }, "detail": { "zh": "仅对应本页所列 DailyMed OTC 文件。", "en": "Only the DailyMed OTC document listed on this page is linked." } }, { "market": { "zh": "中国大陆、欧盟、日本", "en": "Mainland China, EU, Japan" }, "status": { "zh": "待逐项建立市场记录", "en": "Market record not established" }, "detail": { "zh": "不从美国 OTC 标签推定当地批准、持有人、规格、供应或可售资格。", "en": "No local approval, holder, strength, supply or sale-eligibility conclusion is inferred from the U.S. OTC label." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "美国 OTC 标签能代表其他市场或个人用法吗？", "en": "Does a U.S. OTC label represent another market or personal use?" }, "answer": { "zh": "不能。它仅是这一具体美国公开标签的阅读入口；目标市场的现行文件和个人情况必须分别由专业人员核对。", "en": "No. It is only a reading entry point for this specific U.S. public label; the current target-market document and individual circumstances need separate professional review." } }, { "question": { "zh": "为什么不把 OTC 档案写成原始批准或原研结论？", "en": "Why does the OTC archive not state original approval or originator conclusions?" }, "answer": { "zh": "标签记录不足以证明这些结论。它们需要可追溯的产品、剂型、市场、时间和一手监管记录，并经人工审核。", "en": "A label record is insufficient to prove those conclusions. They require traceable product, dosage-form, market, date and primary regulatory records with human review." } } ], "relatedMedicineChecks": [ { "target": { "id": "coumadin", "brand": "Coumadin", "generic": "华法林钠", "canonicalUrls": { "zh": "https://origindrug.com/drugs/coumadin/", "en": "https://origindrug.com/en/drugs/coumadin/" } }, "title": { "zh": "与 COUMADIN／华法林同在药单上时：阿司匹林 81 mg 也应先核对", "en": "When COUMADIN / warfarin is on the same list: aspirin 81 mg also needs review first" }, "summary": { "zh": "BAYER LOW DOSE ASPIRIN 的当前美国公开 Drug Facts 将正在使用抗凝药列为胃出血警示中需要先核对的线索。本卡片只提示把实际阿司匹林包装、华法林包装、其他止痛/感冒药、处方药、非处方药、草本和补充剂交给药师或医生核对；它不判断任何人能否同服，也不建议自行停用、错开时间、替换或调整任何一种药。开始使用或其他变动同样需要先由药师或医生核对。", "en": "The current U.S. public Drug Facts for BAYER LOW DOSE ASPIRIN lists use of an anticoagulant as a cue that needs review in its stomach-bleeding warning. This card only signals that the actual aspirin pack, warfarin pack, other pain/cold products, prescriptions, OTC products, herbs and supplements need review by a pharmacist or clinician; it does not decide whether anyone can use them together or advise self-stopping, time-separation, replacement or adjustment of either medicine. Starting a medicine or making another change also needs pharmacist or clinician review." }, "source": { "id": "src_3c1cad1341a17717", "label": "DailyMed（NLM）：BAYER LOW DOSE ASPIRIN 当前美国公开标签（Bayer HealthCare；SPL v8，抗凝药警示）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=075b103e-0bb4-4b7a-ac0e-5645bcbd0a07&version=8", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "review_complete_medicine_list_no_self_directed_change" } ], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "how-to-read-a-drug-label", "regulatory-sources-first" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/bayer-low-dose-aspirin/", "en": "https://origindrug.com/en/drugs/bayer-low-dose-aspirin/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "avodart", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-23", "status": "published_traceable_archive" }, "names": { "brand": "Avodart", "generic": "度他雄胺", "aliases": [ "dutasteride", "度他雄胺" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "泌尿健康", "sourceArchiveMarket": "美国 AVODART 当前公开标签（DailyMed SPL v4，2025-03-12 生效）", "dosageFormClass": "口服软明胶胶囊：每粒 0.5 mg；本档案精确展示 NDC 80725-712-04 的 90 粒瓶装；不并入 JALYN 复方或其他市场产品", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "2001（DailyMed 当前美国公开标签所列美国初始批准）", "archiveSponsorText": "Waylis Therapeutics LLC / DailyMed 当前公开标签档案" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [ "JALYN", "dutasteride and tamsulosin", "dutasteride/tamsulosin", "度他雄胺坦索罗辛", "度他雄胺/坦索罗辛" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-avodart-dutasteride-softgel-capsule-0-5mg-90count-ndc-80725-712-04", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v4（2025-03-12 生效）", "en": "DailyMed SPL v4 (effective 12 Mar 2025)" }, "dosageForm": { "zh": "AVODART 度他雄胺口服软明胶胶囊", "en": "AVODART dutasteride oral soft gelatin capsule" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 80725-712-04", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_capsule", "primaryDisplay": { "zh": "每粒度他雄胺 0.5 mg；90 粒瓶装", "en": "Dutasteride 0.5 mg per capsule; 90-capsule bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=avodart-spl-image-09.jpg&setid=960797b3-09b1-4d6a-8ece-8b5d918e93e4", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "度他雄胺", "en": "dutasteride" }, "value": 0.5, "unit": "mg", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒标签量；不是个人胶囊数、频率或换药规则", "en": "labelled amount per capsule; not an individual's capsule count, frequency or switching rule" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 90, "countUnit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": null, "package": { "count": 90, "unit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "physicalClues": { "color": { "zh": "暗黄色", "en": "dull yellow" }, "shape": { "zh": "长椭圆形软明胶胶囊", "en": "oblong oval soft gelatin capsule" }, "imprint": "GX CE2", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_4eace7970a6c950b", "label": "DailyMed（NLM）：AVODART 度他雄胺当前美国公开标签（Waylis；SPL v4，2025-03-12 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=960797b3-09b1-4d6a-8ece-8b5d918e93e4", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-avodart-dutasteride-softgel-capsule-0-5mg-90count-ndc-80725-712-04", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=avodart-spl-image-09.jpg&setid=960797b3-09b1-4d6a-8ece-8b5d918e93e4", "alt": "AVODART 度他雄胺 0.5 mg 口服软明胶胶囊在美国 DailyMed 公开标签中的 90 粒瓶装标签图", "archiveMarket": "美国", "labelVersion": "DailyMed SPL v4（2025-03-12 生效）", "presentation": "AVODART 度他雄胺 0.5 mg、NDC 80725-712-04、90 粒瓶装标签图（DailyMed 当前公开标签所列）。", "notice": "此图只对应美国 DailyMed 当前标签中的 AVODART、度他雄胺 0.5 mg、NDC 80725-712-04 与 90 粒瓶装。它只帮助核对品牌、通用名、每粒标示量、软明胶胶囊、包装数量和来源；不用于鉴定真伪，也不证明 JALYN、其他包装、其他市场、当前可得性、原研身份、可替代性或任何个人的胶囊数、联用、开始、停用或换药方案。", "source": { "id": "src_4eace7970a6c950b", "label": "DailyMed（NLM）：AVODART 度他雄胺当前美国公开标签（Waylis；SPL v4，2025-03-12 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=960797b3-09b1-4d6a-8ece-8b5d918e93e4", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "AVODART / 度他雄胺说明书放大阅读：0.5 mg 是每粒胶囊的身份，不是自行调整胶囊数的公式", "en": "AVODART label reading: 0.5 mg identifies each capsule; it is not a formula for self-adjusting capsule count" }, "summary": { "zh": "本模块以美国 DailyMed 当前公开标签为阅读入口，帮助核对 AVODART、度他雄胺、每粒 0.5 mg、口服软明胶胶囊和准确瓶装。它不决定个人胶囊数、是否与坦索罗辛或其他泌尿用药同服、何时停用或怎样换药。", "en": "This module uses the current U.S. DailyMed public label to check AVODART, dutasteride, 0.5 mg per capsule, oral soft gelatin capsules and the exact bottle. It does not decide an individual's capsule count, use with tamsulosin or another urological medicine, stopping time or switching." }, "checks": [ { "zh": "先同时核对 AVODART、度他雄胺、每粒 0.5 mg、NDC 80725-712-04、口服软明胶胶囊、实际包装和目标市场。JALYN 虽含度他雄胺，却是与坦索罗辛组成的复方产品；相同成分、相近名称或毫克数字都不能证明可以自行互换、叠加或按比例换算。", "en": "Check AVODART, dutasteride, 0.5 mg per capsule, NDC 80725-712-04, oral soft gelatin capsule, actual pack and target market together. Although JALYN contains dutasteride, it is a combination product with tamsulosin; a shared ingredient, similar name or milligram number does not establish self-directed substitution, combination or proportional conversion." }, { "zh": "标签将 AVODART 列为有前列腺增大的男性症状性 BPH 的产品；相同的“排尿”或“前列腺”文字，不能证明它与非那雄胺、坦索罗辛、草本或其他泌尿产品可自行叠加、替换或轮换。", "en": "The label identifies AVODART for symptomatic BPH in men with an enlarged prostate. Shared urinary or prostate wording does not establish that it can be self-combined, substituted or alternated with finasteride, tamsulosin, herbs or another urological product." }, { "zh": "美国标签写明软明胶胶囊应整粒吞服，不应咀嚼或打开。该句属于这一准确产品的标签信息；因吞咽困难、包装损坏、外观相近或听到他人经验而需要改变处理方式时，应先由药师或医生核对实际产品。", "en": "The U.S. label says the soft gelatin capsules should be swallowed whole and not chewed or opened. This is label information for this exact product; if swallowing difficulty, package damage, a similar appearance or someone else's experience raises a question about handling, have a pharmacist or clinician check the actual product first." }, { "zh": "美国标签将妊娠列为禁忌，并对孕妇或可能怀孕者接触渗漏胶囊给出专门警示。它是这份美国标签的安全信息，不是网站为实际接触、破损或任何个人情况提供的处理方案；请尽快联系当地药师、医生或适当的医疗支持。", "en": "The U.S. label lists pregnancy as a contraindication and gives a specific warning about contact with leaking capsules by women who are or may be pregnant. It is safety information from this U.S. label, not a website handling plan for an actual contact, damaged pack or any individual situation; contact a local pharmacist, clinician or appropriate medical support promptly." }, { "zh": "正在使用多种泌尿、心血管、激素、非处方或补充剂产品，或准备做前列腺相关检查时，应带实际药盒和完整药单请药师或医生核对；网页不能把标签文字变成个人诊断、检查解释或用药安排。", "en": "When using several urological, cardiovascular, hormonal, OTC or supplement products, or preparing for a prostate-related evaluation, bring the actual packs and complete medicine list to a pharmacist or clinician. A webpage cannot turn label wording into an individual diagnosis, test interpretation or medicine plan." } ], "source": { "id": "src_4eace7970a6c950b", "label": "DailyMed（NLM）：AVODART 度他雄胺当前美国公开标签（Waylis；Warnings and Patient Information）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=960797b3-09b1-4d6a-8ece-8b5d918e93e4", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "度他雄胺怎样起作用：它抑制两种 5α 还原酶，减少睾酮转化为二氢睾酮（DHT）", "en": "How dutasteride works: it inhibits two 5-alpha-reductase types involved in testosterone conversion to DHT" }, "summary": { "zh": "美国 AVODART 标签将度他雄胺描述为 5α 还原酶抑制剂，可抑制 1 型和 2 型 5α 还原酶介导的睾酮转化为二氢睾酮（DHT）。这是作用路径的说明，不判断任何人的排尿症状原因、前列腺大小、检查结果、是否适用、胶囊数或与其他药物的联合方案。", "en": "The U.S. AVODART label describes dutasteride as a 5-alpha-reductase inhibitor that inhibits type 1 and type 2 5-alpha-reductase-mediated conversion of testosterone to dihydrotestosterone (DHT). This explains a pathway, not the cause of anyone's urinary symptoms, prostate size, test result, suitability, capsule count or combination plan." }, "checks": [ { "zh": "“影响 DHT”不等于可从网页判断某人的症状一定来自前列腺增生，或能绕过对其他泌尿、感染、肿瘤或药物相关原因的专业评估。", "en": "“Affects DHT” does not allow a webpage to determine that a person's symptoms are necessarily from BPH or bypass professional assessment of other urinary, infectious, malignant or medicine-related causes." }, { "zh": "同样影响 5α 还原酶或都用于泌尿症状，不使度他雄胺与非那雄胺、坦索罗辛、JALYN 或其他产品可自行叠加、交替、替换或按 mg 换算。", "en": "A related 5-alpha-reductase effect, or use for urinary symptoms, does not make dutasteride self-combinable, alternatable, substitutable or milligram-convertible with finasteride, tamsulosin, JALYN or another product." }, { "zh": "机制不能替代对完整药单、既往反应、检查计划和准确产品标签的核对。考虑开始、停用、换药、打开胶囊或遇到新的明显不适时，应及时联系当地药师或医生。", "en": "Mechanism does not replace review of the complete medicine list, prior reactions, testing plans and the exact product label. For a contemplated start, stop, switch, opening a capsule or a new concerning symptom, contact a local pharmacist or clinician promptly." } ], "source": { "id": "src_4eace7970a6c950b", "label": "DailyMed（NLM）：AVODART 度他雄胺当前美国公开标签（Waylis；Clinical Pharmacology）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=960797b3-09b1-4d6a-8ece-8b5d918e93e4", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "Avodart", "generic": "度他雄胺", "dosageFormClass": "口服软明胶胶囊：每粒 0.5 mg；本档案精确展示 NDC 80725-712-04 的 90 粒瓶装；不并入 JALYN 复方或其他市场产品" }, "labelSource": { "id": "src_4eace7970a6c950b", "label": "DailyMed（NLM）：AVODART 度他雄胺当前美国公开标签（Waylis；SPL v4，2025-03-12 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=960797b3-09b1-4d6a-8ece-8b5d918e93e4", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "productRoutes": [ { "source": { "id": "src_4eace7970a6c950b", "label": "DailyMed（NLM）：AVODART 度他雄胺当前美国公开标签（Waylis；SPL v4，2025-03-12 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=960797b3-09b1-4d6a-8ece-8b5d918e93e4", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-23", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-23", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "本页精确建立美国 AVODART（dutasteride）0.5 mg 口服软明胶胶囊、NDC 80725-712-04、90 粒瓶装的标签阅读身份。JALYN 是度他雄胺与坦索罗辛的复方产品；不得因出现相同成分、相近名称或相同毫克数字，就把它们当作可自行替换、叠加或换算。页面不提供个人胶囊数、联合用药、换药或购买建议。", "history": "本页链接的 DailyMed 公开标签列示 AVODART 的美国初始批准年份为 2001，并将本页所列文件标识为 2025-03-12 生效的 SPL v4。它建立的是一个具体美国公开标签的可回溯阅读路径，不推定中国大陆或其他市场的当前批准、持有人、供应、原研关系或可售资格。", "sourceDocuments": [ { "id": "src_4eace7970a6c950b", "label": "DailyMed（NLM）：AVODART 度他雄胺当前美国公开标签（Waylis；SPL v4，2025-03-12 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=960797b3-09b1-4d6a-8ece-8b5d918e93e4", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, { "id": "src_5ed30b676fbb9773", "label": "FDA Drugs@FDA 官方检索入口", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_lookup_entry", "documentKind": "regulatory_lookup", "market": "US", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } ], "applicationNumber": "NDA 021319（DailyMed 公开标签所列美国市场标识）", "approvalTimeline": [ { "date": "2001", "title": { "zh": "FDA 标签所列美国初始批准年份", "en": "Initial U.S. approval year listed in the FDA label" }, "detail": { "zh": "本页链接的 FDA 标签档案列示 Initial U.S. Approval: 2001。该历史定位不等同于当前批准、可得性、持有人或其他市场状态。", "en": "The FDA label archive linked here lists Initial U.S. Approval: 2001. This historical locator is not a conclusion about current approval, availability, holder or another market." }, "source": { "id": "src_4eace7970a6c950b", "label": "DailyMed: AVODART public label archive", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=960797b3-09b1-4d6a-8ece-8b5d918e93e4", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" } }, { "date": "2025-03-12 SPL v4", "title": { "zh": "FDA 标签档案版本", "en": "FDA label archive version" }, "detail": { "zh": "本页链接 2025-03-12 SPL v4 的 FDA 标签档案作为可复核阅读入口。现行标签、规格、适应症和安全信息必须另行以目标市场当前文件核对。", "en": "This page links the 2025-03-12 SPL v4 FDA label archive as a traceable reading entry point. Current labeling, strength, indication and safety information require separate verification against the target market’s current document." }, "source": { "id": "src_4eace7970a6c950b", "label": "DailyMed: AVODART public label archive", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=960797b3-09b1-4d6a-8ece-8b5d918e93e4", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "已链接公开标签档案", "en": "Public label archive linked" }, "detail": { "zh": "仅对应本页所列 FDA 文件。", "en": "Only the FDA document listed on this page is linked." } }, { "market": { "zh": "中国大陆、欧盟、日本", "en": "Mainland China, EU, Japan" }, "status": { "zh": "待逐项建立市场记录", "en": "Market record not established" }, "detail": { "zh": "不从美国标签档案推定当地批准、持有人、规格、供应或可售资格。", "en": "No local approval, holder, strength, supply or sale-eligibility conclusion is inferred from the U.S. label archive." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "标签档案能代表现在的产品信息吗？", "en": "Does a label archive represent current product information?" }, "answer": { "zh": "不能自动代表。档案用于定位来源；需要以目标市场的现行官方标签逐项复核。", "en": "Not automatically. The archive locates a source; each point needs verification against the target market’s current official label." } }, { "question": { "zh": "为什么这里不展示价格或原研/仿制结论？", "en": "Why are price and originator/generic conclusions not shown?" }, "answer": { "zh": "这些结论需要产品、剂型、规格、包装、市场、日期和原始记录分别齐全并经人工审核；单一标签文件不足以支持。", "en": "Those conclusions require separately complete and human-reviewed product, dosage-form, strength, pack, market, date and primary-record fields; one label file is insufficient." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "how-to-read-a-drug-label", "regulatory-sources-first" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/avodart/", "en": "https://origindrug.com/en/drugs/avodart/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "proscar", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-21", "status": "published_traceable_archive" }, "names": { "brand": "Proscar", "generic": "非那雄胺", "aliases": [ "finasteride" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "泌尿健康", "sourceArchiveMarket": "美国 PROSCAR 当前公开标签（DailyMed 2026-03-18 更新；处方信息 2026-03 修订）", "dosageFormClass": "口服薄膜衣片：每片 5 mg；本档案精确展示 NDC 78206-153-01 的 30 片瓶装；不并入 PROPECIA 1 mg", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "1992（DailyMed 公开标签所列美国初始批准）", "archiveSponsorText": "Organon LLC / DailyMed 公开标签档案" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [ "PROPECIA", "PROPECIA 1 mg", "finasteride 1 mg", "finasteride 1-mg", "非那雄胺 1 mg", "非那雄胺1 mg" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-proscar-finasteride-tablet-5mg-78206-153-01", "marketCode": "US", "labelVersion": { "zh": "DailyMed 2026-03-18 更新；处方信息 2026-03 修订", "en": "DailyMed updated 18 Mar 2026; prescribing information revised Mar 2026" }, "dosageForm": { "zh": "非那雄胺口服薄膜衣片", "en": "finasteride oral film-coated tablet" }, "route": { "zh": "口服（仅作标签产品身份字段）", "en": "oral (label product-identity field only)" }, "routeCodes": [ "oral" ], "productCode": "NDC 78206-153-01", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片 5 mg；30 片瓶装", "en": "5 mg per tablet; 30-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=proscar-07.jpg&setid=6f988153-fc74-4ca4-b29a-111f750c4a4b&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "非那雄胺", "en": "finasteride" }, "value": 5, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人服用片数、换药或换算指令", "en": "labelled amount per tablet; not an individual tablet count, switching or conversion instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "原瓶", "en": "bottle" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-21", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 30, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_98c675ba60dabade", "label": "DailyMed（NLM）：PROSCAR 非那雄胺公开标签（Organon；2026-03 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=6f988153-fc74-4ca4-b29a-111f750c4a4b", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-proscar-finasteride-tablet-5mg-78206-153-01", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=proscar-07.jpg&setid=6f988153-fc74-4ca4-b29a-111f750c4a4b&type=img", "alt": "PROSCAR 非那雄胺 5 mg 口服片在美国 DailyMed 公开标签中的 30 片瓶装标签图", "archiveMarket": "美国", "labelVersion": "DailyMed 公开标签（Organon，2026-03 修订）", "presentation": "PROSCAR 非那雄胺 5 mg、30 片瓶装标签图（DailyMed 公开标签所列）。", "notice": "此为美国 DailyMed 公开标签中明确对应 PROSCAR、非那雄胺 5 mg、30 片瓶装的标签图，只帮助核对品牌、通用名、每片标示含量、薄膜衣片、包装数量和来源；不用于鉴定真伪，也不证明其他包装、其他市场标签、当前包装、原研身份、目标市场批准或可售资格。", "source": { "id": "src_98c675ba60dabade", "label": "DailyMed（NLM）：PROSCAR 公开标签（Organon，2026-03 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=6f988153-fc74-4ca4-b29a-111f750c4a4b", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "PROSCAR / 非那雄胺说明书放大阅读：5 mg 是每片的身份，不是自行调整片数的公式", "en": "PROSCAR label reading: 5 mg identifies each tablet; it is not a formula for self-adjusting tablet count" }, "summary": { "zh": "本模块以美国 DailyMed 2026 公开标签为阅读入口，帮助核对 PROSCAR、非那雄胺、每片 5 mg、口服薄膜衣片和包装警示。它不决定个人用量、是否与坦索罗辛或其他泌尿用药同服、何时停用或怎样换药。", "en": "This module uses the 2026 U.S. DailyMed public label to check PROSCAR, finasteride, 5 mg per tablet, oral film-coated tablets and package warnings. It does not decide an individual's amount, use with tamsulosin or another urological medicine, stopping time or switching." }, "checks": [ { "zh": "先同时核对 PROSCAR、非那雄胺、每片 5 mg、NDC 78206-153-01、口服薄膜衣片、实际包装和目标市场。PROPECIA 虽同为非那雄胺，但美国标签为 1 mg、男性型脱发用途的不同产品；成分相同或毫克数字都不能证明可以自行互换、叠加或按比例换算。", "en": "Check PROSCAR, finasteride, 5 mg per tablet, NDC 78206-153-01, oral film-coated tablet, actual pack and target market together. Although PROPECIA also contains finasteride, its U.S. label is for a distinct 1 mg product for male-pattern hair loss; a shared ingredient or milligram number does not establish self-directed substitution, combination or proportional conversion." }, { "zh": "标签将 PROSCAR 列为有前列腺增大的男性症状性 BPH 的产品；相同的“排尿”或“前列腺”文字，不能证明它与坦索罗辛、度他雄胺、草本或其他泌尿产品可自行叠加、替换或轮换。", "en": "The label identifies PROSCAR for symptomatic BPH in men with an enlarged prostate. Shared urinary or prostate wording does not establish that it can be self-combined, substituted or alternated with tamsulosin, dutasteride, herbs or another urological product." }, { "zh": "美国标签提示：孕妇或可能怀孕者不应使用 PROSCAR，也不应接触压碎或破损的药片。这个警示属于这一准确产品的安全信息；不要因药片外观、药名相近或听到“可以掰半”而自行改变完整片剂的处理方式。", "en": "The U.S. label states that women who are or may be pregnant should not use PROSCAR or handle crushed or broken tablets. This warning is safety information for this exact product; do not change handling of intact tablets because of appearance, a similar name or an assertion that a tablet can be split." }, { "zh": "正在使用多种泌尿、心血管、激素、非处方或补充剂产品，或准备做前列腺相关检查时，应带实际药盒和完整药单请药师或医生核对；网页不能把标签文字变成个人诊断、筛查解释或用药安排。", "en": "When using several urological, cardiovascular, hormonal, OTC or supplement products, or preparing for a prostate-related evaluation, bring the actual packs and complete medicine list to a pharmacist or clinician. A webpage cannot turn label wording into an individual diagnosis, screening interpretation or medicine plan." } ], "source": { "id": "src_98c675ba60dabade", "label": "DailyMed（NLM）：PROSCAR 公开标签（Organon，2026-03 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=6f988153-fc74-4ca4-b29a-111f750c4a4b", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "非那雄胺怎样起作用：它抑制睾酮转化为二氢睾酮（DHT）的一个酶", "en": "How finasteride works: it inhibits an enzyme that converts testosterone to dihydrotestosterone (DHT)" }, "summary": { "zh": "DailyMed 的 PROSCAR 标签将非那雄胺描述为 5α 还原酶抑制剂，可抑制睾酮转化为二氢睾酮（DHT）。这是作用路径的说明，不判断任何人的排尿症状原因、前列腺大小、检查结果、是否适用、片数或与其他药物的联合方案。", "en": "The DailyMed PROSCAR label describes finasteride as a 5-alpha-reductase inhibitor that inhibits conversion of testosterone to dihydrotestosterone (DHT). This explains a pathway, not the cause of anyone's urinary symptoms, prostate size, test result, suitability, tablet count or combination plan." }, "checks": [ { "zh": "“影响 DHT”不等于可从网页判断某人的症状一定来自前列腺增生，或能绕过对其他泌尿、感染、肿瘤或药物相关原因的专业评估。", "en": "“Affects DHT” does not allow a webpage to determine that a person's symptoms are necessarily from BPH or bypass professional assessment of other urinary, infectious, malignant or medicine-related causes." }, { "zh": "同样影响 5α 还原酶或都用于泌尿症状，不使非那雄胺与度他雄胺、坦索罗辛或其他产品可自行叠加、交替、替换或按 mg 换算。", "en": "A related 5-alpha-reductase effect, or use for urinary symptoms, does not make finasteride self-combinable, alternatable, substitutable or milligram-convertible with dutasteride, tamsulosin or another product." }, { "zh": "机制不能替代对完整药单、既往反应、检查计划和准确产品标签的核对。考虑开始、停用、换药、掰开药片或遇到新的明显不适时，应及时联系当地药师或医生。", "en": "Mechanism does not replace review of the complete medicine list, prior reactions, testing plans and the exact product label. For a contemplated start, stop, switch, tablet splitting or a new concerning symptom, contact a local pharmacist or clinician promptly." } ], "source": { "id": "src_98c675ba60dabade", "label": "DailyMed（NLM）：PROSCAR 公开标签（Clinical Pharmacology）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=6f988153-fc74-4ca4-b29a-111f750c4a4b", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "Proscar", "generic": "非那雄胺", "dosageFormClass": "口服薄膜衣片：每片 5 mg；本档案精确展示 NDC 78206-153-01 的 30 片瓶装；不并入 PROPECIA 1 mg" }, "labelSource": { "id": "src_98c675ba60dabade", "label": "DailyMed（NLM）：PROSCAR 公开标签（Organon，2026-03 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=6f988153-fc74-4ca4-b29a-111f750c4a4b", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "productRoutes": [ { "source": { "id": "src_98c675ba60dabade", "label": "DailyMed（NLM）：PROSCAR 公开标签（Organon，2026-03 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=6f988153-fc74-4ca4-b29a-111f750c4a4b", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "本页精确建立美国 PROSCAR（finasteride）5 mg 口服薄膜衣片、NDC 78206-153-01、30 片瓶装的标签阅读身份。PROPECIA 是同成分但 1 mg、男性型脱发标签用途的不同产品；不得因成分相同、名称相近或毫克数字而把两者当作可自行替换、叠加或换算。页面不提供个人片数、联合用药、换药或购买建议。", "history": "本页链接的 DailyMed 公开标签列示 PROSCAR 的美国初始批准年份为 1992、标签修订为 2026-03；这建立的是具体美国标签的可回溯阅读路径，不推定中国大陆或其他市场的当前批准、持有人、供应、原研关系或可售资格。", "sourceDocuments": [ { "id": "src_98c675ba60dabade", "label": "DailyMed（NLM）：PROSCAR 公开标签（Organon，2026-03 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=6f988153-fc74-4ca4-b29a-111f750c4a4b", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_5ed30b676fbb9773", "label": "FDA Drugs@FDA 官方检索入口", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_lookup_entry", "documentKind": "regulatory_lookup", "market": "US", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } ], "applicationNumber": "NDA 020180（DailyMed 公开标签所列美国市场标识）", "approvalTimeline": [ { "date": "1992", "title": { "zh": "FDA 标签所列美国初始批准年份", "en": "Initial U.S. approval year listed in the FDA label" }, "detail": { "zh": "本页链接的 FDA 标签档案列示 Initial U.S. Approval: 1992。该历史定位不等同于当前批准、可得性、持有人或其他市场状态。", "en": "The FDA label archive linked here lists Initial U.S. Approval: 1992. This historical locator is not a conclusion about current approval, availability, holder or another market." }, "source": { "id": "src_98c675ba60dabade", "label": "DailyMed: PROSCAR public label archive", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=6f988153-fc74-4ca4-b29a-111f750c4a4b", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, { "date": "2026-03", "title": { "zh": "FDA 标签档案版本", "en": "FDA label archive version" }, "detail": { "zh": "本页链接 2026-03 的 FDA 标签档案作为可复核阅读入口。现行标签、规格、适应症和安全信息必须另行以目标市场当前文件核对。", "en": "This page links the 2026-03 FDA label archive as a traceable reading entry point. Current labeling, strength, indication and safety information require separate verification against the target market’s current document." }, "source": { "id": "src_98c675ba60dabade", "label": "DailyMed: PROSCAR public label archive", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=6f988153-fc74-4ca4-b29a-111f750c4a4b", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "已链接公开标签档案", "en": "Public label archive linked" }, "detail": { "zh": "仅对应本页所列 FDA 文件。", "en": "Only the FDA document listed on this page is linked." } }, { "market": { "zh": "中国大陆、欧盟、日本", "en": "Mainland China, EU, Japan" }, "status": { "zh": "待逐项建立市场记录", "en": "Market record not established" }, "detail": { "zh": "不从美国标签档案推定当地批准、持有人、规格、供应或可售资格。", "en": "No local approval, holder, strength, supply or sale-eligibility conclusion is inferred from the U.S. label archive." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "标签档案能代表现在的产品信息吗？", "en": "Does a label archive represent current product information?" }, "answer": { "zh": "不能自动代表。档案用于定位来源；需要以目标市场的现行官方标签逐项复核。", "en": "Not automatically. The archive locates a source; each point needs verification against the target market’s current official label." } }, { "question": { "zh": "为什么这里不展示价格或原研/仿制结论？", "en": "Why are price and originator/generic conclusions not shown?" }, "answer": { "zh": "这些结论需要产品、剂型、规格、包装、市场、日期和原始记录分别齐全并经人工审核；单一标签文件不足以支持。", "en": "Those conclusions require separately complete and human-reviewed product, dosage-form, strength, pack, market, date and primary-record fields; one label file is insufficient." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "how-to-read-a-drug-label", "regulatory-sources-first" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/proscar/", "en": "https://origindrug.com/en/drugs/proscar/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "aldactone", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-09-04", "status": "published_traceable_archive" }, "names": { "brand": "Aldactone", "generic": "螺内酯", "aliases": [ "ALDACTONE", "spironolactone", "spironolactone tablets", "螺内酯片", "NDA 012151", "0025-1001-31", "0025-1041-31", "0025-1031-31" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "心血管", "sourceArchiveMarket": "美国当前 ALDACTONE 螺内酯公开标签（DailyMed SPL v25，2025-12-01 发布）", "dosageFormClass": "口服薄膜衣片：25 mg、50 mg、100 mg（当前美国标签所列）", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "1960（当前美国标签所列 Initial U.S. Approval）", "archiveSponsorText": "Pfizer Laboratories Div Pfizer Inc / DailyMed（NLM）当前公开标签档案" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [ "ALDACTAZIDE", "spironolactone hydrochlorothiazide" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-aldactone-tablet-25mg-ndc-0025-1001-31", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v25，2025-12-01 发布", "en": "DailyMed SPL v25, published 1 Dec 2025" }, "dosageForm": { "zh": "ALDACTONE 螺内酯口服薄膜衣片", "en": "ALDACTONE spironolactone film-coated oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 0025-1001-31", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片 25 mg；100 片瓶装", "en": "25 mg per tablet; 100-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=0fed2822-3a03-4b64-9857-c682fcd462bc&type=img&name=aldactone-05.jpg", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "螺内酯", "en": "spironolactone" }, "value": 25, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标示量；不是个人片数、利尿或补钾方案", "en": "labelled amount per tablet; not an individual's tablet count, diuretic or potassium plan" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-04", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_440d6bed9c6e0881", "label": "DailyMed（NLM）：ALDACTONE 螺内酯当前美国公开标签（Pfizer；SPL v25，2025-12-01 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=0fed2822-3a03-4b64-9857-c682fcd462bc", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-aldactone-tablet-50mg-ndc-0025-1041-31", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v25，2025-12-01 发布", "en": "DailyMed SPL v25, published 1 Dec 2025" }, "dosageForm": { "zh": "ALDACTONE 螺内酯口服薄膜衣片", "en": "ALDACTONE spironolactone film-coated oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 0025-1041-31", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片 50 mg；100 片瓶装", "en": "50 mg per tablet; 100-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=0fed2822-3a03-4b64-9857-c682fcd462bc&type=img&name=aldactone-06.jpg", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "螺内酯", "en": "spironolactone" }, "value": 50, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标示量；不是个人片数、利尿或补钾方案", "en": "labelled amount per tablet; not an individual's tablet count, diuretic or potassium plan" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-04", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_440d6bed9c6e0881", "label": "DailyMed（NLM）：ALDACTONE 螺内酯当前美国公开标签（Pfizer；SPL v25，2025-12-01 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=0fed2822-3a03-4b64-9857-c682fcd462bc", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-aldactone-tablet-100mg-ndc-0025-1031-31", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v25，2025-12-01 发布", "en": "DailyMed SPL v25, published 1 Dec 2025" }, "dosageForm": { "zh": "ALDACTONE 螺内酯口服薄膜衣片", "en": "ALDACTONE spironolactone film-coated oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 0025-1031-31", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片 100 mg；100 片瓶装", "en": "100 mg per tablet; 100-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=0fed2822-3a03-4b64-9857-c682fcd462bc&type=img&name=aldactone-07.jpg", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "螺内酯", "en": "spironolactone" }, "value": 100, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标示量；不是个人片数、利尿或补钾方案", "en": "labelled amount per tablet; not an individual's tablet count, diuretic or potassium plan" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-04", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_440d6bed9c6e0881", "label": "DailyMed（NLM）：ALDACTONE 螺内酯当前美国公开标签（Pfizer；SPL v25，2025-12-01 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=0fed2822-3a03-4b64-9857-c682fcd462bc", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-aldactone-tablet-25mg-ndc-0025-1001-31", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=0fed2822-3a03-4b64-9857-c682fcd462bc&type=img&name=aldactone-05.jpg", "alt": "ALDACTONE 螺内酯在美国 DailyMed Pfizer 当前公开标签中的 25 mg、NDC 0025-1001-31、100 片瓶装展示面", "archiveMarket": "美国", "labelVersion": "DailyMed SPL v25（2025-12-01 发布）", "presentation": "ALDACTONE 螺内酯：每片 25 mg，NDC 0025-1001-31，100 片瓶装展示面。", "notice": "此图只对应美国 DailyMed 当前标签中的 ALDACTONE、螺内酯 25 mg、NDC 0025-1001-31 与 100 片瓶装。它只帮助核对品牌、通用名、每片标示量、口服片、包装数量与来源；不用于鉴定真伪，也不证明 50 mg、100 mg、ALDACTAZIDE、其他包装、其他市场、当前可得性、原研身份、可替代性或任何个人的片数、利尿、补钾、联用、开始、停用或换药方案。", "source": { "id": "src_440d6bed9c6e0881", "label": "DailyMed（NLM）：ALDACTONE 螺内酯当前美国公开标签（Pfizer；SPL v25，2025-12-01 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=0fed2822-3a03-4b64-9857-c682fcd462bc", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "ALDACTONE 说明书放大阅读：25、50、100 mg 先是每片身份，不是利尿或补钾方案", "en": "ALDACTONE label reading: 25, 50 and 100 mg identify each tablet; they are not a diuretic or potassium plan" }, "summary": { "zh": "本模块以美国 DailyMed 当前公开标签为阅读入口，帮助核对 ALDACTONE、螺内酯、每片 25/50/100 mg、口服薄膜衣片和准确瓶装。它不决定个人的片数、血钾监测、饮食、补充剂、利尿安排或与其他心血管产品的联合方案。", "en": "This module uses the current U.S. DailyMed public label to check ALDACTONE, spironolactone, 25/50/100 mg per tablet, film-coated oral tablets and the exact bottle. It does not decide an individual's tablet count, potassium monitoring, diet, supplements, diuretic plan or combination with another cardiovascular product." }, "checks": [ { "zh": "先把 ALDACTONE、螺内酯、每片 25、50 或 100 mg、口服片、实际 NDC 和目标市场一起核对。毫克数是这一准确片剂的标示量，不是网页可换算成个人片数、隔天使用或由一盒替换另一盒的规则。", "en": "Check ALDACTONE, spironolactone, 25, 50 or 100 mg per tablet, oral-tablet form, actual NDC and target market together. Milligrams are the labelled amount in an exact tablet, not a web rule for personal tablet count, alternate-day use or replacing one pack with another." }, { "zh": "标签对高钾血症、肾功能恶化、低血压和电解质异常列有警示，也提示钾补充剂、高钾食物和盐替代品需要核对。它们不是网站可以据此给个人作出“该补/不该补、该吃/不该吃”结论的依据；请把药盒、补充剂、非处方药和完整药单交给药师或医生。", "en": "The label includes warnings about hyperkalaemia, worsening renal function, hypotension and electrolyte abnormalities, and flags potassium supplements, high-potassium foods and salt substitutes for review. These do not let a website decide whether an individual should use or avoid a product; take the packs, supplements, OTC products and complete medicine list to a pharmacist or clinician." }, { "zh": "“利尿剂”“醛固酮拮抗剂”或“保钾”都是类别线索，不表示可以把 ALDACTONE 与其他利尿剂、降压药、心衰药、补钾产品或草本自行叠加、轮换或替换。每个产品的强度、剂型、目标市场标签、既往反应和检查结果都需一起复核。", "en": "“Diuretic”, “aldosterone antagonist” and “potassium-sparing” are class clues; they do not permit self-combining, alternating or replacing ALDACTONE with another diuretic, blood-pressure medicine, heart-failure medicine, potassium product or herb. Strength, dosage form, target-market label, prior reactions and test results all need review together." }, { "zh": "标签把其他升高血钾的药物或产品、NSAIDs（常见于止痛退热药）、锂盐列为需要专业核对的联用线索。NSAIDs 可能减弱利尿、排钠或降压作用；利尿剂也可能降低锂清除并增加锂毒性风险。看到这些名称时应核对完整药单、肾功能及相关检查，而不是自行错开时间、停药或加减量。", "en": "The label identifies other potassium-raising products, NSAIDs (common in pain or fever medicines) and lithium as co-medication clues requiring professional review. NSAIDs may reduce diuretic, natriuretic or antihypertensive effects, while diuretics may reduce lithium clearance and increase lithium-toxicity risk. When these names appear, the complete medicine list, kidney function and relevant tests need review rather than self-separating timing, stopping or changing an amount." }, { "zh": "当前美国标签列示的辅料包括硫酸钙、玉米淀粉、香料、羟丙甲纤维素、氧化铁、硬脂酸镁、聚乙二醇、聚维酮和二氧化钛。辅料表只对应这一准确美国标签，可用于向药师询问过敏或耐受问题；不能据此断言另一厂牌更差、疗效不同或可以自行替换。", "en": "The current U.S. label lists inactive ingredients including calcium sulfate, corn starch, flavour, hypromellose, iron oxide, magnesium stearate, polyethylene glycol, povidone and titanium dioxide. This excipient list applies only to the exact U.S. label and can frame allergy or tolerability questions for a pharmacist; it does not prove another manufacturer is inferior, has different efficacy or can be self-substituted." }, { "zh": "出现晕厥、明显心悸或无力、呼吸困难、严重呕吐腹泻、意识变化或其他急性严重不适时，应优先使用当地紧急医疗支持；不要等待网页检索，也不要靠另一盒药自行抵消或调整。", "en": "With fainting, marked palpitations or weakness, breathing difficulty, severe vomiting or diarrhoea, altered consciousness or another acute severe problem, prioritise local emergency medical support; do not wait for a website search or self-counteract or adjust with another pack." } ], "source": { "id": "src_440d6bed9c6e0881", "label": "DailyMed（NLM）：ALDACTONE 螺内酯当前美国公开标签（Pfizer；Warnings and Patient Counseling）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=0fed2822-3a03-4b64-9857-c682fcd462bc", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "螺内酯怎样起作用：它阻断醛固酮的作用路径", "en": "How spironolactone works: it blocks an aldosterone pathway" }, "summary": { "zh": "美国 ALDACTONE 标签将螺内酯描述为醛固酮拮抗剂，并说明其在远端肾小管拮抗醛固酮。这个机制帮助阅读药物类别和标签警示；不预测个人体液变化、血压、血钾、适用性、片数或任何联用方案。", "en": "The U.S. ALDACTONE label describes spironolactone as an aldosterone antagonist acting at the distal renal tubule. This mechanism helps read the drug class and label warnings; it does not predict an individual's fluid change, blood pressure, potassium, suitability, tablet count or any combination plan." }, "checks": [ { "zh": "“阻断醛固酮”解释的是一个生理作用路径，不是从网页判断水肿、血压、乏力、心悸或化验异常原因的工具。需要治疗或调整时，应由专业人员结合准确诊断、检查和完整药单判断。", "en": "“Blocking aldosterone” explains one physiologic pathway; it is not a website tool for determining the cause of oedema, blood pressure, fatigue, palpitations or an abnormal test. Need for treatment or adjustment requires a professional with the exact diagnosis, tests and complete medicine list." }, { "zh": "机制与“保钾”名称都不能替代对肾功能、电解质、其他心血管药、止痛药、补充剂或盐替代品的个体化核对。不要从机制词自行添加、去掉或补用任何药物或补充剂。", "en": "Neither the mechanism nor the phrase “potassium-sparing” replaces individual review of kidney function, electrolytes, other cardiovascular medicines, pain medicines, supplements or salt substitutes. Do not self-add, remove or make up any medicine or supplement from a mechanism word." }, { "zh": "与其他影响体液、血压或肾脏相关路径的产品同用时，不能仅凭“类别不同”或“机制不同”判断一定能联用。带上完整药单与实际包装让药师或医生核对，才是下一步。", "en": "When another product affects fluid balance, blood pressure or kidney-related pathways, neither a different class nor a different mechanism proves it can be combined. Bringing the complete medicine list and actual packs to a pharmacist or clinician is the next step." } ], "source": { "id": "src_440d6bed9c6e0881", "label": "DailyMed（NLM）：ALDACTONE 螺内酯当前美国公开标签（Pfizer；Clinical Pharmacology）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=0fed2822-3a03-4b64-9857-c682fcd462bc", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "Aldactone", "generic": "螺内酯", "dosageFormClass": "口服薄膜衣片：25 mg、50 mg、100 mg（当前美国标签所列）" }, "labelSource": { "id": "src_440d6bed9c6e0881", "label": "DailyMed（NLM）：ALDACTONE 螺内酯当前美国公开标签（Pfizer；SPL v25，2025-12-01 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=0fed2822-3a03-4b64-9857-c682fcd462bc", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "productRoutes": [ { "source": { "id": "src_440d6bed9c6e0881", "label": "DailyMed（NLM）：ALDACTONE 螺内酯当前美国公开标签（Pfizer；SPL v25，2025-12-01 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=0fed2822-3a03-4b64-9857-c682fcd462bc", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_102d35b70ca3a4e3", "label": "DailyMed（NLM）：ALDACTONE 当前美国电子说明书 PDF（可放大阅读）", "url": "https://dailymed.nlm.nih.gov/dailymed/downloadpdffile.cfm?setId=0fed2822-3a03-4b64-9857-c682fcd462bc", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-09-04", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "美国 DailyMed 的 ALDACTONE 公开标签将其列为螺内酯口服薄膜衣片，并列示 25 mg、50 mg、100 mg 三种片剂。此页帮助核对品牌、通用名、每片强度、瓶装、标签版本和来源；不把标签文字转换为个人片数、利尿、补钾、联用、停用或换药方案。", "history": "本页对应 Pfizer Laboratories Div Pfizer Inc 在美国 DailyMed 当前标签体系中的 ALDACTONE。高龄、心力衰竭、肾脏问题、肝病、水肿或多药并用时，更不能只凭“利尿”“保钾”或相同毫克数自行增减、合并或替换；需由药师或医生结合准确产品和完整药单核对。", "sourceDocuments": [ { "id": "src_440d6bed9c6e0881", "label": "DailyMed（NLM）：ALDACTONE 螺内酯当前美国公开标签（Pfizer；SPL v25，2025-12-01 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=0fed2822-3a03-4b64-9857-c682fcd462bc", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_102d35b70ca3a4e3", "label": "DailyMed（NLM）：ALDACTONE 当前美国电子说明书 PDF（可放大阅读）", "url": "https://dailymed.nlm.nih.gov/dailymed/downloadpdffile.cfm?setId=0fed2822-3a03-4b64-9857-c682fcd462bc", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" }, { "id": "src_23e9da0a651a03b6", "label": "FDA：ALDACTONE（螺内酯）片 NDA 012151/S-080 补充批准函（2025-11-19）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/012151Orig1s080ltr.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "approval_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } ], "applicationNumber": "NDA 012151", "approvalTimeline": [ { "date": "1960", "title": { "zh": "当前标签所列美国初始批准年份", "en": "Initial U.S. approval year listed in the current label" }, "detail": { "zh": "当前 ALDACTONE 标签列示 Initial U.S. Approval: 1960；该年份不自动说明其他市场的产品状态。", "en": "The current ALDACTONE label lists Initial U.S. Approval: 1960; it does not establish product status in another market." }, "source": { "id": "src_440d6bed9c6e0881", "label": "DailyMed（NLM）：ALDACTONE 螺内酯当前美国公开标签（Pfizer；SPL v25，2025-12-01 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=0fed2822-3a03-4b64-9857-c682fcd462bc", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, { "date": "2025-11-19", "title": { "zh": "NDA 012151 S-080 补充批准", "en": "NDA 012151 S-080 supplemental approval" }, "detail": { "zh": "FDA 公开批准函记录 ALDACTONE（螺内酯）片剂的 NDA 012151/S-080 于 2025-11-19 获批。该监管节点不建立个人适用性、联用、调整或其他市场状态。", "en": "The FDA public approval letter records approval of NDA 012151/S-080 for ALDACTONE (spironolactone) tablets on 19 Nov 2025. This regulatory node does not establish individual suitability, combination, adjustment or another-market status." }, "source": { "id": "src_23e9da0a651a03b6", "label": "FDA：ALDACTONE（螺内酯）片 NDA 012151/S-080 补充批准函（2025-11-19）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/012151Orig1s080ltr.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "approval_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, { "date": "2025-12-01", "title": { "zh": "DailyMed 公开当前 SPL v25", "en": "Current SPL v25 published on DailyMed" }, "detail": { "zh": "DailyMed 将当前 ALDACTONE SPL v25 的 Published Date 列为 2025-12-01。该公开日期、标签图片和 NDC 仅用于记录身份，不能说明个人使用、库存、可得性或替代关系。", "en": "DailyMed lists 1 Dec 2025 as the Published Date for the current ALDACTONE SPL v25. The public date, label image and NDC record identity only; they do not establish individual use, stock, availability or interchangeability." }, "source": { "id": "src_440d6bed9c6e0881", "label": "DailyMed（NLM）：ALDACTONE 螺内酯当前美国公开标签（Pfizer；SPL v25，2025-12-01 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=0fed2822-3a03-4b64-9857-c682fcd462bc", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "已链接当前标签与 3 个精确瓶装展示面", "en": "Current label and three exact bottle panels linked" }, "detail": { "zh": "本页分别记录 25 mg、50 mg、100 mg 的特定 NDC 与 100 片瓶装展示面；不据此建立实际在售、库存、个人用量、补钾、联用、换药或其他规格状态。", "en": "This page records the specified NDC and 100-tablet bottle panel separately for 25 mg, 50 mg and 100 mg; it does not establish actual marketing, stock, individual use, potassium management, combination, switching or another-presentation status." } }, { "market": { "zh": "中国大陆、欧盟、日本及其他市场", "en": "Mainland China, EU, Japan and other markets" }, "status": { "zh": "待逐项建立市场记录", "en": "Market record not established" }, "detail": { "zh": "不从美国标签推定当地商品名、批准、包装、供应、原研关系或可替代性。", "en": "No local trade name, approval, packaging, supply, originator relationship or interchangeability is inferred from the U.S. label." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "25、50、100 mg 能否只按毫克数自行换成片数或另一盒？", "en": "Can 25, 50 and 100 mg be self-converted into tablet counts or another bottle?" }, "answer": { "zh": "不能。它们是当前标签分别列出的准确片剂身份。网页不把包装数字变成个人片数、隔天使用、补钾、联用、替代或调整规则；请携带实际药盒与完整药单咨询药师或医生。", "en": "No. They are distinct tablet identities listed in the current label. This page does not turn package numbers into an individual's tablet count, alternate-day use, potassium plan, combination, substitution or adjustment rule; take the actual pack and complete medicine list to a pharmacist or clinician." } }, { "question": { "zh": "“保钾”是否说明可以自行添加或去掉补钾产品、盐替代品或其他药？", "en": "Does “potassium-sparing” mean a person can self-add or remove potassium products, salt substitutes or another medicine?" }, "answer": { "zh": "不能。这是机制和类别线索，不是个体化联用结论。肾功能、电解质、既往反应、其他药物和准确标签都需要由专业人员一起核对。", "en": "No. It is a mechanism and class clue, not an individual combination conclusion. Kidney function, electrolytes, prior reactions, other medicines and the exact label all require joint professional review." } } ], "relatedMedicineChecks": [ { "target": { "id": "klor-con", "brand": "KLOR-CON", "generic": "氯化钾", "canonicalUrls": { "zh": "https://origindrug.com/drugs/klor-con/", "en": "https://origindrug.com/en/drugs/klor-con/" } }, "title": { "zh": "与 KLOR-CON／氯化钾同在药单上时：先核对血钾、肾功能与完整药单", "en": "When KLOR-CON / potassium chloride is on the same list: review potassium, kidney function and the complete medicine list first" }, "summary": { "zh": "ALDACTONE 的美国公开标签提示，与补钾产品或其他可升高血钾的药物同用可能导致高钾血症，肾功能受损时风险更高。本卡片只提示把 ALDACTONE、KLOR-CON、其他处方药、非处方药、补充剂、盐替代品及相关检查交给药师或开方团队核对；它不判断能否同用，也不建议自行停用、错开时间、替换或调整任何一种药。", "en": "The U.S. public ALDACTONE label says co-use with potassium supplementation or other medicines that can increase potassium may lead to hyperkalaemia, with greater risk in renal impairment. This card only signals that ALDACTONE, KLOR-CON, other prescription medicines, OTC products, supplements, salt substitutes and relevant tests need review by a pharmacist or prescribing team; it does not decide co-use or advise self-stopping, time-separation, replacement or adjustment of either medicine." }, "source": { "id": "src_440d6bed9c6e0881", "label": "DailyMed（NLM）：ALDACTONE 螺内酯当前美国公开标签（Pfizer；Drug Interactions）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=0fed2822-3a03-4b64-9857-c682fcd462bc", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "review_complete_medicine_list_no_self_directed_change" } ], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "dosage-forms-are-part-of-medicine-identity", "how-to-read-a-drug-label" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/aldactone/", "en": "https://origindrug.com/en/drugs/aldactone/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "viagra", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-25", "status": "published_traceable_archive" }, "names": { "brand": "VIAGRA", "generic": "西地那非", "aliases": [ "万艾可", "sildenafil", "sildenafil citrate", "西地那非", "VGR25", "VGR50", "VGR100", "0069-4200-30", "0069-4210-30", "0069-4220-30" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": { "value": "万艾可®", "status": "discovery_cue_requires_target_market_verification", "source": { "id": "src_3e8b33a11c6fae95", "label": "中国政府网转载食药监总局风险提示：万艾可／西地那非商品名线索（2016）", "url": "https://app.www.gov.cn/govdata/gov/201605/16/380625/article.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "regulatory_safety_notice", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-12", "reviewedAt": "2026-09-12" } } }, "identity": { "therapeuticArea": "泌尿健康", "sourceArchiveMarket": "美国 DailyMed 有日期公开标签（SPL v32，2017-12-15 生效）", "dosageFormClass": "口服薄膜衣片：25 mg、50 mg、100 mg（所引美国公开标签分别列示）", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "1998（所引美国标签列示 Initial U.S. Approval）", "archiveSponsorText": "Pfizer Laboratories Div Pfizer Inc（美国 DailyMed 公开标签所列）" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-viagra-sildenafil-tablet-25mg-30-bottle-ndc-0069-4200-30", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v32（2017-12-15 生效）", "en": "DailyMed SPL v32 (effective 2017-12-15)" }, "dosageForm": { "zh": "薄膜衣口服片", "en": "film-coated oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [], "productCode": "NDC 0069-4200-30", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "VIAGRA 西地那非 25 mg、30 片瓶装", "en": "VIAGRA sildenafil 25 mg, 30-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=viagra-11.jpg&setid=0b0be196-0c62-461c-94f4-9a35339b4501&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "西地那非（每片）", "en": "Sildenafil (per tablet)" }, "value": 25, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标示量；不是个人剂量", "en": "Labelled amount per tablet; not an individual dose" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": null, "package": { "count": 30, "unit": { "zh": "片", "en": "tablets" } }, "physicalClues": { "color": { "zh": "蓝色", "en": "blue" }, "shape": { "zh": "圆角菱形", "en": "rounded diamond" }, "imprint": { "zh": "VGR25 / PFIZER", "en": "VGR25 / PFIZER" }, "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_2fdb4edd1fba9d51", "label": "DailyMed（NLM）：VIAGRA 25 mg、30 片瓶装展示面（Pfizer，SPL v32）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=0b0be196-0c62-461c-94f4-9a35339b4501", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-viagra-sildenafil-tablet-50mg-30-bottle-ndc-0069-4210-30", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v32（2017-12-15 生效）", "en": "DailyMed SPL v32 (effective 2017-12-15)" }, "dosageForm": { "zh": "薄膜衣口服片", "en": "film-coated oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [], "productCode": "NDC 0069-4210-30", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "VIAGRA 西地那非 50 mg、30 片瓶装", "en": "VIAGRA sildenafil 50 mg, 30-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=viagra-12.jpg&setid=0b0be196-0c62-461c-94f4-9a35339b4501&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "西地那非（每片）", "en": "Sildenafil (per tablet)" }, "value": 50, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标示量；不是个人剂量", "en": "Labelled amount per tablet; not an individual dose" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": null, "package": { "count": 30, "unit": { "zh": "片", "en": "tablets" } }, "physicalClues": { "color": { "zh": "蓝色", "en": "blue" }, "shape": { "zh": "圆角菱形", "en": "rounded diamond" }, "imprint": { "zh": "VGR50 / PFIZER", "en": "VGR50 / PFIZER" }, "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_2fdb4edd1fba9d51", "label": "DailyMed（NLM）：VIAGRA 50 mg、30 片瓶装展示面（Pfizer，SPL v32）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=0b0be196-0c62-461c-94f4-9a35339b4501", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-viagra-sildenafil-tablet-100mg-30-bottle-ndc-0069-4220-30", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v32（2017-12-15 生效）", "en": "DailyMed SPL v32 (effective 2017-12-15)" }, "dosageForm": { "zh": "薄膜衣口服片", "en": "film-coated oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [], "productCode": "NDC 0069-4220-30", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "VIAGRA 西地那非 100 mg、30 片瓶装", "en": "VIAGRA sildenafil 100 mg, 30-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=viagra-13.jpg&setid=0b0be196-0c62-461c-94f4-9a35339b4501&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "西地那非（每片）", "en": "Sildenafil (per tablet)" }, "value": 100, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标示量；不是个人剂量", "en": "Labelled amount per tablet; not an individual dose" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": null, "package": { "count": 30, "unit": { "zh": "片", "en": "tablets" } }, "physicalClues": { "color": { "zh": "蓝色", "en": "blue" }, "shape": { "zh": "圆角菱形", "en": "rounded diamond" }, "imprint": { "zh": "VGR100 / PFIZER", "en": "VGR100 / PFIZER" }, "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_2fdb4edd1fba9d51", "label": "DailyMed（NLM）：VIAGRA 100 mg、30 片瓶装展示面（Pfizer，SPL v32）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=0b0be196-0c62-461c-94f4-9a35339b4501", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-viagra-sildenafil-tablet-50mg-30-bottle-ndc-0069-4210-30", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=viagra-12.jpg&setid=0b0be196-0c62-461c-94f4-9a35339b4501&type=img", "alt": "VIAGRA 西地那非在美国 DailyMed Pfizer 公开标签中的 50 mg、NDC 0069-4210-30、30 片瓶装标签展示面", "archiveMarket": "美国", "labelVersion": "DailyMed SPL v32（2017-12-15 生效）", "presentation": "VIAGRA 西地那非：每片 50 mg，NDC 0069-4210-30，30 片瓶装展示面（DailyMed Pfizer 公开标签所列）。", "notice": "此图只对应所引美国 DailyMed 标签中的 VIAGRA、西地那非 50 mg、NDC 0069-4210-30 与 30 片瓶装。它只帮助核对品牌、通用名、每片标示量、口服片、包装数量、标签外观和来源；不用于鉴定真伪，也不证明 25 mg、100 mg、其他包装、其他市场、当前可得性、原研身份、可替代性或任何个人的片数、开始、停用、联用或换药方案。", "source": { "id": "src_2fdb4edd1fba9d51", "label": "DailyMed（NLM）：VIAGRA 西地那非美国公开标签（Pfizer；SPL v32，2017-12-15 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=0b0be196-0c62-461c-94f4-9a35339b4501", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "VIAGRA 说明书放大阅读：25、50、100 mg 是不同片剂身份，不是自行加减片数的公式", "en": "VIAGRA label reading: 25, 50 and 100 mg identify different tablets; they are not a formula for self-adjusting tablet count" }, "summary": { "zh": "本模块以所引美国 DailyMed 有日期公开标签为阅读入口，帮助核对 VIAGRA、西地那非、每片 25/50/100 mg、蓝色圆角菱形外观、刻印、NDC 与 30 片瓶装。它不提供任何人的服用片数、开始、停用、联用、换药或与其他西地那非产品的换算方案。", "en": "This module uses the cited dated U.S. DailyMed label to check VIAGRA, sildenafil, 25/50/100 mg per tablet, blue rounded-diamond appearance, imprints, NDCs and 30-tablet bottles. It does not provide an individual's tablet count, start, stop, combination, switch or conversion plan with another sildenafil product." }, "checks": [ { "zh": "先把 VIAGRA、西地那非、每片 25、50 或 100 mg、口服片、NDC、瓶装数量和目标市场作为一组核对。毫克数是这一准确片剂的标示量，不是从网页计算个人片数、加量、补用或由一盒换成另一盒的规则。", "en": "Check VIAGRA, sildenafil, 25, 50 or 100 mg per tablet, oral-tablet form, NDC, bottle count and target market as one set. Milligrams are the labelled amount in an exact tablet, not a web rule for personal tablet count, escalation, make-up use or replacing one pack with another." }, { "zh": "所引标签将三种强度均描述为蓝色圆角菱形薄膜衣片，并以 VGR25、VGR50 或 VGR100 及 PFIZER 刻印区分。颜色、形状或单个数字只能作为身份线索；不能凭照片、外观或相同成分确认真伪、当前包装或可替代性。", "en": "The cited label describes all three strengths as blue rounded-diamond film-coated tablets and distinguishes them with VGR25, VGR50 or VGR100 plus PFIZER. Colour, shape or a single number are identity clues only; a photograph, appearance or shared ingredient cannot authenticate a product, establish current packaging or establish interchangeability." }, { "zh": "标签将任何形式的有机硝酸酯或一氧化氮供体列为禁忌，并提示其他可能影响血压或药物暴露的产品需要专业核对。正在用心血管药、泌尿药、非处方药、补充剂或草本时，应带完整药单请药师或开方团队逐项核对；不要从网页自行停用、错开、叠加或借用药物。", "en": "The label lists organic nitrates or nitric-oxide donors in any form as a contraindication and flags other products that can affect blood pressure or drug exposure for professional review. With cardiovascular, urinary, OTC, supplement or herbal products, take the complete medicine list to a pharmacist or prescriber for item-by-item review; do not self-stop, separate, stack or borrow medicines from a webpage." }, { "zh": "出现胸痛、晕厥、突发视力或听力变化，或其他急性严重不适时，应优先按当地紧急医疗渠道处理；不要等待网页检索，也不要用另一盒药自行抵消、调整或补用。", "en": "With chest pain, fainting, sudden vision or hearing changes, or another acute serious concern, prioritise local emergency care; do not wait for a website search or self-counteract, adjust or make up use with another pack." } ], "source": { "id": "src_2fdb4edd1fba9d51", "label": "DailyMed（NLM）：VIAGRA 西地那非美国公开标签（Pfizer；SPL v32，2017-12-15 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=0b0be196-0c62-461c-94f4-9a35339b4501", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "西地那非怎样起作用：它选择性抑制 PDE5，但机制不决定个人是否适用", "en": "How sildenafil works: it selectively inhibits PDE5, but mechanism does not decide individual suitability" }, "summary": { "zh": "所引美国标签将西地那非描述为环磷酸鸟苷特异性磷酸二酯酶 5 型（PDE5）的选择性抑制剂。它解释药物作用路径，不判断任何人的勃起、胸痛、血压、心血管风险、是否适用、片数或与其他产品的联用方案。", "en": "The cited U.S. label describes sildenafil as a selective inhibitor of cyclic guanosine monophosphate-specific phosphodiesterase type 5 (PDE5). It explains a drug-action pathway; it does not determine anyone's erection, chest pain, blood pressure, cardiovascular risk, suitability, tablet count or combination plan with another product." }, "checks": [ { "zh": "把 PDE5 理解为这一药物作用的一条生物学路径即可。机制文字不能反推某个人症状的原因，也不能替代对心血管状况、血压、既往反应、完整药单和准确产品标签的专业评估。", "en": "Read PDE5 as one biological pathway through which this medicine acts. Mechanism wording cannot infer the cause of a person's symptoms or replace professional review of cardiovascular status, blood pressure, prior reactions, the complete medicine list and exact product label." }, { "zh": "同样含西地那非、同样写着 PDE5 或看起来都有相近颜色的产品，并不自动成为可互换、可叠加或可按毫克换算的关系。剂型、市场、强度、其他成分和现行标签都要逐项核对。", "en": "Products that share sildenafil, mention PDE5 or look similarly coloured do not automatically become interchangeable, combinable or milligram-convertible. Dosage form, market, strength, other ingredients and the current label all need item-by-item review." }, { "zh": "对相互作用、既往不适、心血管问题或正在使用硝酸酯等产品的担忧，最有用的下一步是携带准确药盒和完整药单联系药师或医生；机制说明不能替代这一核对。", "en": "For concerns about interactions, prior effects, cardiovascular issues or products such as nitrates, the most useful next step is to bring the exact pack and complete medicine list to a pharmacist or clinician; a mechanism explanation cannot replace that review." } ], "source": { "id": "src_2fdb4edd1fba9d51", "label": "DailyMed（NLM）：VIAGRA 西地那非美国公开标签（Clinical Pharmacology；Pfizer，SPL v32）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=0b0be196-0c62-461c-94f4-9a35339b4501", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "VIAGRA", "generic": "西地那非", "dosageFormClass": "口服薄膜衣片：25 mg、50 mg、100 mg（所引美国公开标签分别列示）" }, "labelSource": { "id": "src_2fdb4edd1fba9d51", "label": "DailyMed（NLM）：VIAGRA 西地那非美国公开标签（Pfizer；SPL v32，2017-12-15 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=0b0be196-0c62-461c-94f4-9a35339b4501", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "productRoutes": [ { "source": { "id": "src_2fdb4edd1fba9d51", "label": "DailyMed（NLM）：VIAGRA 西地那非美国公开标签（Pfizer；SPL v32，2017-12-15 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=0b0be196-0c62-461c-94f4-9a35339b4501", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "美国 DailyMed 的 VIAGRA 公开标签将其列为西地那非柠檬酸盐口服薄膜衣片，分别列示 25 mg、50 mg、100 mg 三种每片标示量及对应的 30 片瓶装展示面。此页帮助核对品牌、通用名、每片强度、外观、NDC 与来源；不把毫克、瓶数或产品名称变成任何人的服用片数、开始、停用、换药或联用方案。", "history": "所引 DailyMed 标签由 Pfizer Laboratories Div Pfizer Inc 作为品牌标签人列示，标签注明 Initial U.S. Approval: 1998。该档案为有日期的美国公开文件，不证明中国大陆或其他市场的当前品牌、包装、批准、供应、原研/仿制关系或可售资格。", "sourceDocuments": [ { "id": "src_2fdb4edd1fba9d51", "label": "DailyMed（NLM）：VIAGRA 西地那非美国公开标签（Pfizer；SPL v32，2017-12-15 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=0b0be196-0c62-461c-94f4-9a35339b4501", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_5ed30b676fbb9773", "label": "FDA Drugs@FDA 官方检索入口", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_lookup_entry", "documentKind": "regulatory_lookup", "market": "US", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } ], "applicationNumber": "DailyMed SPL setid 0b0be196-0c62-461c-94f4-9a35339b4501（美国有日期公开标签记录；本档案不据此推定其他市场状态）", "approvalTimeline": [ { "date": "1998", "title": { "zh": "所引美国标签列示初始批准年份", "en": "Initial U.S. approval year listed in the cited label" }, "detail": { "zh": "所引 VIAGRA 美国 DailyMed 公开标签列示 Initial U.S. Approval: 1998。该年份只定位此美国标签的历史信息；不建立中国大陆、欧盟、日本或其他市场的批准、供应、可售资格、原研/仿制关系、可替代性或个人适用性。", "en": "The cited U.S. DailyMed public label for VIAGRA lists Initial U.S. Approval: 1998. This year only locates the history of this U.S. label; it does not establish approval, supply, sale eligibility, originator/generic relationship, interchangeability or individual suitability in Mainland China, the EU, Japan or another market." }, "source": { "id": "src_2fdb4edd1fba9d51", "label": "DailyMed（NLM）：VIAGRA 西地那非美国公开标签（Pfizer；SPL v32，2017-12-15 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=0b0be196-0c62-461c-94f4-9a35339b4501", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, { "date": "2017-12-15", "title": { "zh": "所引 DailyMed SPL v32 生效日期", "en": "Effective date of the cited DailyMed SPL v32" }, "detail": { "zh": "所引 VIAGRA 标签为 SPL v32，Effective Time 为 2017-12-15。本页分别展示 25 mg、NDC 0069-4200-30；50 mg、NDC 0069-4210-30；100 mg、NDC 0069-4220-30 的 30 片瓶装标签身份。该有日期记录不建立当前在售、库存、购买、个人片数、联用、停用、换药或其他市场状态。", "en": "The cited VIAGRA label is SPL v32 with an effective time of 15 Dec 2017. This page separately displays the label identities for the 30-tablet bottles: 25 mg/NDC 0069-4200-30, 50 mg/NDC 0069-4210-30 and 100 mg/NDC 0069-4220-30. This dated record does not establish current marketing, stock, purchase, individual tablet count, co-use, stopping, switching or another-market status." }, "source": { "id": "src_2fdb4edd1fba9d51", "label": "DailyMed（NLM）：VIAGRA 西地那非美国公开标签（Pfizer；SPL v32，2017-12-15 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=0b0be196-0c62-461c-94f4-9a35339b4501", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "已链接有日期公开标签与三组准确 30 片瓶装身份", "en": "Dated public label and three exact 30-tablet bottle identities linked" }, "detail": { "zh": "本页分别记录 VIAGRA 西地那非 25 mg、NDC 0069-4200-30；50 mg、NDC 0069-4210-30；100 mg、NDC 0069-4220-30 的 30 片瓶装标签面板。它只用于品牌、通用名、每片标示量、NDC、包装和来源阅读，不用于鉴定真伪，也不建立当前在售、库存、购买、个人片数、开始、停用、联用、换药或可替代性。", "en": "This page records the label panels for VIAGRA sildenafil 25 mg/NDC 0069-4200-30, 50 mg/NDC 0069-4210-30 and 100 mg/NDC 0069-4220-30 30-tablet bottles. They are only for reading brand, generic name, labelled amount per tablet, NDC, package and source; they do not authenticate a product or establish current marketing, stock, purchase, individual tablet count, initiation, stopping, co-use, switching or interchangeability." } }, { "market": { "zh": "中国大陆、欧盟、日本及其他市场", "en": "Mainland China, EU, Japan and other markets" }, "status": { "zh": "待逐项建立现行市场记录", "en": "Current market record not established" }, "detail": { "zh": "不从美国历史标签、SPL、NDC、英文商品名、包装图或标签主体推定当地商品名、批准、包装、供应、可售资格、原研/仿制关系或可替代性；每个市场均须按当地现行监管资料单独核对。", "en": "No local trade name, approval, packaging, supply, sale eligibility, originator/generic relationship or interchangeability is inferred from the historical U.S. label, SPL, NDC, English brand, package image or label holder; every market requires separate checking against current local regulatory material." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "25、50、100 mg 或 30 片瓶装能否告诉我该吃几片、能否加减、或换成另一种西地那非产品？", "en": "Can 25, 50 or 100 mg, or a 30-tablet bottle, tell me how many to take, whether to adjust, or whether I can change to another sildenafil product?" }, "answer": { "zh": "不能。这些字段只识别所引美国标签中的准确产品和包装。共同成分、相近毫克数、外观或包装照片都不建立自行开始、增加、补用、停用、联用、轮换或替代关系；请带实际药盒、现行处方和完整药单请药师或开方团队复核。", "en": "No. These fields only identify exact products and packs in the cited U.S. label. A shared ingredient, nearby milligram number, appearance or package photo does not establish self-initiation, increase, make-up use, stopping, co-use, alternation or substitution; have a pharmacist or prescriber review the actual pack, current prescription and complete medicine list." } }, { "question": { "zh": "为什么页面提到硝酸酯、胸痛和急性不适，却不告诉我是否该停用？", "en": "Why does the page mention nitrates, chest pain and acute concerns without telling me whether to stop?" }, "answer": { "zh": "这些是所引美国标签中禁忌和警示段落的阅读入口，不是个体化风险判断或治疗决策。出现胸痛、晕厥、突发视力或听力变化，或其他急性严重不适时，应优先使用当地紧急医疗支持；任何产品变更需由了解实际处方、病史和完整药单的专业人员核对。", "en": "These are reading entry points for contraindications and warnings in the cited U.S. label, not an individual risk assessment or treatment decision. With chest pain, fainting, sudden vision or hearing changes, or another acute serious concern, prioritise local emergency medical support; any product change needs review by a professional who knows the actual prescription, history and complete medicine list." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "dosage-forms-are-part-of-medicine-identity", "how-to-read-a-drug-label" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/viagra/", "en": "https://origindrug.com/en/drugs/viagra/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "diamicron-mr", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-26", "status": "published_traceable_archive" }, "names": { "brand": "DIAMICRON MR", "generic": "格列齐特", "aliases": [ "Diamicron", "Diamicron MR", "gliclazide", "格列齐特", "格列齐特缓释片", "格列齐特缓释", "MR gliclazide", "达美康缓释片", "达美康", "DIAMICRON MR", "Diamicron 60 mg MR", "ARTG 154042" ], "marketBrandNames": [ { "name": "达美康", "market": { "zh": "中国大陆（2025 年医院公开记录）", "en": "Mainland China (2025 public hospital record)" }, "evidenceStatus": "dated_public_record", "note": { "zh": "青岛市第三人民医院 2025 年 5 月 26 日公开记录列有“格列齐特缓释片（达美康）”、15×60 mg、缓释片和施维雅（天津）制药有限公司。这里帮助按中文药盒名称查找；它不是现行批准、当前价格或在售证明。下方澳大利亚 DIAMICRON 60 mg MR 说明书属于另一个市场，不能据此确认中国药盒的用法或互换关系。", "en": "Qingdao Third People's Hospital's public record dated 26 May 2025 lists gliclazide modified-release tablets (达美康), 15 × 60 mg and Servier (Tianjin) Pharmaceutical Co., Ltd. This is a Chinese pack-name search clue, not evidence of current authorization, price or availability. The Australian DIAMICRON 60 mg MR leaflet below belongs to a separate market and does not establish instructions or interchangeability for a Chinese pack." }, "source": { "id": "src_bfcd3ef4b4a99670", "label": "青岛政务网：青岛市第三人民医院药品公开记录（2025-05-26；达美康名称核对）", "url": "https://www.qingdao.gov.cn/ywdt/zwzl/ggqsydwgk/wsjk_208049/yy/qdsdsyy/zzbs/jg/202506/t20250604_9610087.shtml", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "public_hospital_record", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-12", "reviewedAt": "2026-09-12" } } ], "mainlandChinaTradeNameCue": { "value": "达美康®", "status": "discovery_cue_requires_target_market_verification", "source": { "id": "src_6886ccd150c2c1fd", "label": "济宁市人民政府：2026 年基层医疗机构药品信息中的达美康／格列齐特缓释片 60 mg 记录", "url": "https://dlrk.jining.gov.cn/art/2026/4/28/art_91842_2879444.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "government_medicine_listing", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-12", "reviewedAt": "2026-09-12" } } }, "identity": { "therapeuticArea": "代谢", "sourceArchiveMarket": "澳大利亚：TGA ARTG 154042 当前公开记录列示 DIAMICRON 60 mg MR gliclazide 60 mg tablet blister pack，并提供 Product Information（PI）及 Consumer Medicine Information（CMI）入口。本页不从该记录推定中国大陆、美国、欧盟或其他市场的批准、名称、包装、供应、可售资格、原研/仿制关系或可替代性。", "dosageFormClass": "格列齐特 60 mg MR（modified release，缓释）口服片；TGA ARTG 154042 所列泡罩包装", "dosageFormClassCode": "oral_modified_release", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "2009-11-11（澳大利亚 TGA ARTG 154042 登记日期）", "archiveSponsorText": "Servier Laboratories (Aust) Pty Ltd（TGA ARTG 154042 所列 sponsor）" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [ "gliclazide immediate-release tablet", "格列齐特普通片", "GLICLAZIDE SANDOZ MR", "other gliclazide product", "其他格列齐特产品" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "au-diamicron-mr-gliclazide-60mg-tablet-blister-artg-154042", "marketCode": "AU", "labelVersion": { "zh": "TGA ARTG 154042（2026-08-26 核验）", "en": "TGA ARTG 154042 (verified 26 Aug 2026)" }, "dosageForm": { "zh": "DIAMICRON 60 mg MR 格列齐特缓释口服片", "en": "DIAMICRON 60 mg MR gliclazide modified-release oral tablet" }, "route": { "zh": "口服（产品身份字段）", "en": "oral (product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "ARTG 154042", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片 60 mg；MR 缓释片；泡罩包装（澳大利亚 TGA ARTG）", "en": "60 mg labelled per tablet; MR modified-release tablet; blister pack (Australian TGA ARTG)" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "格列齐特", "en": "gliclazide" }, "value": 60, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、频率或换算指令", "en": "Labelled amount per tablet; not an individual's tablet count, schedule or conversion instruction" } } ], "concentration": null, "container": { "typeCode": "blister_pack", "typeLabel": { "zh": "泡罩包装", "en": "blister pack" }, "fill": null, "countPerPackage": null, "countUnit": null }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": null, "package": null, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_afebe6851e8205e9", "label": "澳大利亚 TGA：DIAMICRON 60 mg MR gliclazide 60 mg tablet blister pack（ARTG 154042）", "url": "https://www.tga.gov.au/resources/artg/154042", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "status": "withheld_repackaged_or_non_exact_visual", "title": { "zh": "已核验 TGA 产品级记录与官方电子说明书，但未保留可一一对应的官方包装图，故不展示包装图片", "en": "The TGA product-level record and official electronic leaflets were reviewed, but no one-to-one official package image was retained, so no package visual is shown" }, "summary": { "zh": "本档案保留 TGA ARTG 154042 中 DIAMICRON 60 mg MR、格列齐特 60 mg 片、MR 缓释剂型、泡罩包装及 PI/CMI 入口。此次没有保留可与这一准确 ARTG 展示面逐一对应的官方包装图；为避免把零售图、版本不明图、其他市场图或普通片图片误作准确 DIAMICRON MR 包装，页面不展示包装图片，只保留官方电子说明书供放大阅读。", "en": "This dossier retains DIAMICRON 60 mg MR, gliclazide 60 mg tablets, the MR modified-release form, blister packaging and PI/CMI routes in TGA ARTG 154042. No official package image that can be matched one-to-one to this exact ARTG presentation was retained; to avoid treating a retail image, version-uncertain image, another-market image or immediate-release-tablet image as an exact DIAMICRON MR package, the page withholds package imagery and retains the official electronic leaflets for enlarged reading." }, "source": { "id": "src_afebe6851e8205e9", "label": "澳大利亚 TGA：DIAMICRON 60 mg MR（ARTG 154042）", "url": "https://www.tga.gov.au/resources/artg/154042", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "DIAMICRON MR 说明书放大阅读：60 mg 与 MR 先是准确片剂身份", "en": "DIAMICRON MR label reading: 60 mg and MR identify an exact tablet first" }, "summary": { "zh": "本模块只阅读 TGA ARTG 154042 及其官方 PI/CMI 入口中的 DIAMICRON 60 mg MR、格列齐特、每片 60 mg、缓释片和泡罩包装。它不提供个人片数、开始、漏用处理、进餐、分片、研碎、同服、停用、换药或购买方案。", "en": "This module reads only DIAMICRON 60 mg MR, gliclazide, 60 mg per tablet, modified-release form and blister packaging in TGA ARTG 154042 and its official PI/CMI routes. It provides no individual tablet count, start, missed-use handling, meals, splitting, crushing, co-use, stopping, switching or purchase plan." }, "checks": [ { "zh": "先同时核对 DIAMICRON MR、格列齐特、每片 60 mg、MR（缓释）、泡罩包装、ARTG 154042 与目标市场。60 mg 是这一准确澳大利亚缓释片的标签标示量，不是网页可换算成个人片数、把两种强度相加或由普通片替代的规则。", "en": "Check DIAMICRON MR, gliclazide, 60 mg per tablet, MR (modified release), blister pack, ARTG 154042 and target market together. 60 mg is the labelled amount for this exact Australian modified-release tablet, not a web rule for personal tablet counts, adding strengths or replacing it with an immediate-release tablet." }, { "zh": "MR 是剂型身份，不只是药名后的字母。格列齐特普通片、另一持有人产品、其他缓释产品或其他市场包装，即使通用名或毫克数相同，也不能仅凭名称当作同一产品、自动互换或自行并用。", "en": "MR is part of dosage-form identity, not just letters after a name. A gliclazide immediate-release tablet, another sponsor's product, another modified-release product or another-market pack is not the same product merely because a generic name or milligram number matches; none becomes automatically interchangeable or suitable for self-directed co-use." }, { "zh": "PI/CMI 是准确产品的官方电子说明书入口。任何与低血糖、既往反应、肾肝问题、其他降糖药、饮酒、非处方药或补充剂有关的问题，都应把实际药盒、现行处方和完整药单交由药师或开方团队按当前文件逐项核对；本页不据此决定继续、暂停、补用或改变治疗。", "en": "The PI/CMI are official electronic-leaflet routes for the exact product. Questions about low blood glucose, prior reactions, kidney/liver problems, another glucose-lowering medicine, alcohol, OTC products or supplements require the actual pack, current prescription and complete medicine list to be checked item by item by a pharmacist or prescriber against current documents; this page does not decide continuation, pausing, make-up use or a treatment change." }, { "zh": "出现意识改变、抽搐、昏厥、呼吸困难、严重过敏表现或其他急性严重不适时，应使用当地紧急与医疗渠道；不要等待网页检索，也不要依据本页自行加药、停药或用另一盒药抵消。", "en": "For altered consciousness, seizure, fainting, breathing difficulty, serious allergic features or another acute severe concern, use local urgent and medical pathways; do not wait for a web search or self-add, stop or counteract with another pack based on this page." } ], "source": { "id": "src_afebe6851e8205e9", "label": "澳大利亚 TGA：DIAMICRON 60 mg MR 官方 Product Information / Consumer Medicine Information 入口", "url": "https://www.tga.gov.au/resources/artg/154042", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "格列齐特怎样起作用：它促使胰岛 β 细胞分泌胰岛素（机制说明，不是血糖方案）", "en": "How gliclazide works: it stimulates insulin secretion from pancreatic beta cells (a mechanism, not a glucose plan)" }, "summary": { "zh": "TGA 公开的 DIAMICRON MR 产品信息将格列齐特描述为口服磺脲类降糖药，并说明其可通过促使胰岛 β 细胞分泌胰岛素来降低血糖。本段只解释活性成分的作用路径；本档案的准确产品身份仍仅以 ARTG 154042 所列 DIAMICRON 60 mg MR 缓释片为准，机制不决定任何人的血糖、是否适用、每次片数、进餐、联用、暂停或替代。", "en": "TGA-released DIAMICRON MR product information describes gliclazide as an oral sulfonylurea that can lower blood glucose by stimulating insulin secretion from pancreatic beta cells. This explains an active-ingredient pathway only. The exact product identity in this dossier remains the DIAMICRON 60 mg MR modified-release tablet in ARTG 154042; mechanism does not determine anyone's glucose, suitability, tablet count, meals, co-use, pausing or substitution." }, "checks": [ { "zh": "“促使胰岛素分泌”不能解释某一次血糖变化、出汗、头晕、乏力或其他不适的原因，也不能让网页判断任何人应怎样处理。出现实际症状或读数问题时，请带实际药盒、处方和完整药单联系当地药师、开方团队或适当医疗支持。", "en": "“Stimulates insulin secretion” cannot explain the cause of one glucose change, sweating, dizziness, weakness or another symptom, and it cannot tell a webpage how any person should respond. With an actual symptom or reading concern, take the real pack, prescription and complete medicine list to a local pharmacist, prescriber or appropriate medical support." }, { "zh": "同为“降糖药”或都影响胰岛素，不表示 DIAMICRON MR 可与其他格列齐特、胰岛素、其他降糖药、非处方药、补充剂或饮酒自行叠加、错开、轮换或替代。产品的剂型、强度、目标市场标签和完整药单需要一起核对。", "en": "Being glucose-lowering products, or both affecting insulin, does not make DIAMICRON MR self-combinable, time-separable, alternatable or substitutable with another gliclazide product, insulin, another glucose-lowering medicine, OTC product, supplement or alcohol. Dosage form, strength, target-market label and the complete medicine list need review together." }, { "zh": "MR（缓释）属于准确片剂身份；作用机制并不授权掰开、研碎、把普通片与缓释片相互换算，或从毫克数字推导个人片数。对外观、吞咽、漏用、其他药物或生活方式有疑问时，应以当前官方说明书和专业人员核对为下一步。", "en": "MR (modified release) is part of exact tablet identity. A mechanism explanation does not authorise splitting, crushing, converting an immediate-release tablet and a modified-release tablet, or deriving a personal tablet count from a milligram number. For questions about appearance, swallowing, missed use, other medicines or lifestyle, the next step is the current official leaflet and professional review." } ], "source": { "id": "src_4c11bad3827c57ef", "label": "澳大利亚 TGA：DIAMICRON MR 产品信息（FOI 067-1314，药理章节；历史公开文件）", "url": "https://www.tga.gov.au/sites/default/files/foi-067-1314-1.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "DIAMICRON MR", "generic": "格列齐特", "dosageFormClass": "格列齐特 60 mg MR（modified release，缓释）口服片；TGA ARTG 154042 所列泡罩包装" }, "labelSource": { "id": "src_afebe6851e8205e9", "label": "澳大利亚 TGA：DIAMICRON 60 mg MR gliclazide 60 mg tablet blister pack（ARTG 154042）", "url": "https://www.tga.gov.au/resources/artg/154042", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" }, "productRoutes": [ { "source": { "id": "src_afebe6851e8205e9", "label": "澳大利亚 TGA：DIAMICRON 60 mg MR gliclazide 60 mg tablet blister pack（ARTG 154042）", "url": "https://www.tga.gov.au/resources/artg/154042", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" }, "status": "product_level_public_record_verified", "authority": { "zh": "TGA", "en": "TGA" }, "market": { "zh": "澳大利亚", "en": "Australia" }, "recordType": { "zh": "监管产品记录或公开说明书", "en": "Regulatory product record or public product information" }, "reviewedAt": "2026-08-28", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_3fd2581eec98dada", "label": "澳大利亚 TGA eBS：DIAMICRON 60 mg MR Product Information（PI）官方入口", "url": "https://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent=&id=CP-2010-PI-03389-3", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_document_with_terms", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" }, "status": "product_level_public_record_verified", "authority": { "zh": "TGA", "en": "TGA" }, "market": { "zh": "澳大利亚", "en": "Australia" }, "recordType": { "zh": "监管产品记录或公开说明书", "en": "Regulatory product record or public product information" }, "reviewedAt": "2026-08-28", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_d4f5f1aa968cc2fe", "label": "澳大利亚 DIAMICRON 60 mg MR 患者说明书：2022 年版，未确认现行（MIMS 发布，ACSQHC 托管）", "url": "https://www.safetyandquality.gov.au/documents/de0382dc-d3d4-4c12-b131-a53300ff4a49?cmiFormat=pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-12", "reviewedAt": "2026-09-12" }, "status": "public_product_record_verified", "authority": { "zh": "公开产品记录来源", "en": "Public product-record source" }, "market": { "zh": "以原始文件为准", "en": "See original document" }, "recordType": { "zh": "公开产品记录", "en": "Public product record" }, "reviewedAt": "2026-09-12", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_4c11bad3827c57ef", "label": "澳大利亚 TGA：DIAMICRON MR 产品信息（FOI 067-1314，药理章节；历史公开文件）", "url": "https://www.tga.gov.au/sites/default/files/foi-067-1314-1.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" }, "status": "product_level_public_record_verified", "authority": { "zh": "TGA", "en": "TGA" }, "market": { "zh": "澳大利亚", "en": "Australia" }, "recordType": { "zh": "监管产品记录或公开说明书", "en": "Regulatory product record or public product information" }, "reviewedAt": "2026-08-28", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "TGA", "en": "TGA" }, "market": { "zh": "澳大利亚", "en": "Australia" }, "recordType": { "zh": "监管产品记录或公开说明书", "en": "Regulatory product record or public product information" }, "reviewedAt": "2026-08-28", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "TGA 的产品级登记记录可核对 DIAMICRON 60 mg MR、格列齐特、每片 60 mg、modified release（MR）与泡罩包装，并直达该准确澳大利亚产品的 PI 和 CMI。页面帮助读者先辨认名称、剂型、每片标示量、市场和官方电子说明书；不把 mg、MR、包装数字或“降糖药”类别转换为个人片数、进餐、漏用、联用、停用、换药、替代或购买结论。", "history": "本档案以澳大利亚 TGA ARTG 154042 为产品身份锚点：ARTG 名称为 DIAMICRON 60 mg MR gliclazide 60 mg tablet blister pack，登记日期为 2009-11-11，所列 sponsor 为 Servier Laboratories (Aust) Pty Ltd。MR 是该准确片剂身份的一部分；相同通用名、类似品牌名或同写 60 mg，均不能证明普通片、其他缓释片、其他包装或其他市场产品可自行掰开、互换、叠加、轮换或替代。", "sourceDocuments": [ { "id": "src_afebe6851e8205e9", "label": "澳大利亚 TGA：DIAMICRON 60 mg MR gliclazide 60 mg tablet blister pack（ARTG 154042）", "url": "https://www.tga.gov.au/resources/artg/154042", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" }, { "id": "src_3fd2581eec98dada", "label": "澳大利亚 TGA eBS：DIAMICRON 60 mg MR Product Information（PI）官方入口", "url": "https://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent=&id=CP-2010-PI-03389-3", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_document_with_terms", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" }, { "id": "src_a27efd02f220275e", "label": "澳大利亚 TGA eBS：DIAMICRON 60 mg MR Consumer Medicine Information（CMI）官方入口", "url": "https://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent=&id=CP-2010-CMI-03390-3", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "consumer_medicine_information", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_document_with_terms", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" }, { "id": "src_d4f5f1aa968cc2fe", "label": "澳大利亚 DIAMICRON 60 mg MR 患者说明书：2022 年版，未确认现行（MIMS 发布，ACSQHC 托管）", "url": "https://www.safetyandquality.gov.au/documents/de0382dc-d3d4-4c12-b131-a53300ff4a49?cmiFormat=pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-12", "reviewedAt": "2026-09-12" }, { "id": "src_4c11bad3827c57ef", "label": "澳大利亚 TGA：DIAMICRON MR 产品信息（FOI 067-1314，药理章节；历史公开文件）", "url": "https://www.tga.gov.au/sites/default/files/foi-067-1314-1.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" } ], "applicationNumber": "澳大利亚 TGA ARTG 154042（DIAMICRON 60 mg MR gliclazide 60 mg tablet blister pack）", "approvalTimeline": [ { "date": "2009-11-11", "title": { "zh": "TGA ARTG 登记日期", "en": "TGA ARTG registration date" }, "detail": { "zh": "TGA ARTG 154042 将 DIAMICRON 60 mg MR gliclazide 60 mg tablet blister pack 的 ARTG Date 列为 2009-11-11。该日期只定位这一个澳大利亚监管产品记录，不建立其他市场的批准、供应、可售资格、原研/仿制关系或个人适用性。", "en": "TGA ARTG 154042 lists 11 Nov 2009 as the ARTG date for DIAMICRON 60 mg MR gliclazide 60 mg tablet blister pack. This date locates only this Australian regulatory product record; it does not establish approval, supply, sale eligibility, originator/generic relationship or individual suitability in another market." }, "source": { "id": "src_afebe6851e8205e9", "label": "澳大利亚 TGA：DIAMICRON 60 mg MR（ARTG 154042）", "url": "https://www.tga.gov.au/resources/artg/154042", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" } }, { "date": "2026-08-26", "title": { "zh": "产品级记录与 PI/CMI 入口复核", "en": "Product-level record and PI/CMI entry routes verified" }, "detail": { "zh": "本轮核验可从 TGA ARTG 154042 直达该产品的 Product Information（PI）与 Consumer Medicine Information（CMI）入口。PI/CMI 由相关 sponsor 提供给 TGA 发布；页面仅把它们作为原始阅读入口，不将其转换为个人片数、停用、换药或购买结论。", "en": "This review confirmed that TGA ARTG 154042 links to this product's Product Information (PI) and Consumer Medicine Information (CMI) routes. The PI/CMI are supplied to TGA by the relevant sponsor for publication; this page presents them only as primary reading routes and does not turn them into individual tablet-count, stopping, switching or purchase conclusions." }, "source": { "id": "src_a27efd02f220275e", "label": "澳大利亚 TGA eBS：DIAMICRON 60 mg MR PI/CMI 官方入口", "url": "https://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent=&id=CP-2010-CMI-03390-3", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "consumer_medicine_information", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_document_with_terms", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" } } ], "marketStatus": [ { "market": { "zh": "澳大利亚", "en": "Australia" }, "status": { "zh": "已链接 TGA ARTG 产品级记录与 PI/CMI 官方入口", "en": "TGA ARTG product-level record and official PI/CMI routes linked" }, "detail": { "zh": "本页只记录 ARTG 154042 中的 DIAMICRON 60 mg MR、格列齐特 60 mg 片、MR 缓释剂型与泡罩包装；不用于鉴定真伪，也不建立实际在售、库存、购买、个人片数、联用、停用、换药或可替代性。", "en": "This page records only DIAMICRON 60 mg MR, gliclazide 60 mg tablets, the MR modified-release form and blister packaging in ARTG 154042; it does not authenticate a product or establish actual marketing, stock, purchase, individual tablet count, co-use, stopping, switching or interchangeability." } }, { "market": { "zh": "中国大陆、美国、欧盟、日本及其他市场", "en": "Mainland China, the United States, the EU, Japan and other markets" }, "status": { "zh": "待逐项建立现行市场记录", "en": "Current market record not established" }, "detail": { "zh": "不从澳大利亚 ARTG 名称、登记日期、sponsor、PI/CMI 或泡罩包装推定当地商品名、批准、包装、供应、可售资格、原研/仿制关系或可替代性；每个市场均须按当地现行监管资料单独核对。", "en": "No local trade name, approval, packaging, supply, sale eligibility, originator/generic relationship or interchangeability is inferred from the Australian ARTG name, date, sponsor, PI/CMI or blister pack; every market requires separate checking against current local regulatory material." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "DIAMICRON MR 的 60 mg、MR 与泡罩包装能告诉我该吃几片，或能否换成普通格列齐特片吗？", "en": "Can DIAMICRON MR's 60 mg, MR and blister pack tell me how many to take or whether I can change to an immediate-release gliclazide tablet?" }, "answer": { "zh": "不能。这些字段只识别 TGA ARTG 154042 所列的准确澳大利亚缓释片。共同通用名、相近 mg、相似品牌或包装文字都不建立自行开始、增加、补用、掰开、研碎、停用、联用、轮换或替代关系；请带实际药盒、现行处方和完整药单请药师或开方团队核对。", "en": "No. These fields identify only the exact Australian modified-release tablet in TGA ARTG 154042. A shared generic name, nearby mg number, similar brand or package wording does not establish self-initiation, increase, make-up use, splitting, crushing, stopping, co-use, alternation or substitution; have a pharmacist or prescriber review the actual pack, current prescription and complete medicine list." } }, { "question": { "zh": "为什么页面给出 PI/CMI 链接，却不直接给我调整用法？", "en": "Why does the page link the PI/CMI without directly telling me to change use?" }, "answer": { "zh": "PI/CMI 是这个准确产品的官方原始阅读入口，但具体治疗决定需要把处方、实际包装、其他药物、既往反应和健康状况放在一起核对。不要仅因网页、标题或单一说明书段落自行停药、换药、加量、减量或错开时间。", "en": "The PI/CMI are official primary reading routes for this exact product, but treatment decisions require the prescription, actual pack, other medicines, prior reactions and health status to be reviewed together. Do not self-stop, switch, increase, reduce or separate timing from a webpage, headline or one leaflet section alone." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "dosage-forms-are-part-of-medicine-identity", "how-to-read-a-drug-label" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/diamicron-mr/", "en": "https://origindrug.com/en/drugs/diamicron-mr/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "avalide", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-30", "status": "published_traceable_archive" }, "names": { "brand": "AVALIDE", "generic": "厄贝沙坦/氢氯噻嗪", "aliases": [ "Avalide", "安博诺", "安博诺®", "厄贝沙坦氢氯噻嗪片", "厄贝沙坦/氢氯噻嗪", "irbesartan hydrochlorothiazide", "irbesartan and hydrochlorothiazide", "irbesartan/hydrochlorothiazide", "厄贝沙坦 氢氯噻嗪", "AVALIDE" ], "marketBrandNames": [ { "name": "安博诺®", "market": { "zh": "中国大陆（赛诺菲中国当前产品页）", "en": "Mainland China (current Sanofi China product page)" }, "evidenceStatus": "publication_status_unresolved", "note": { "zh": "赛诺菲中国当前产品页将安博诺®对应为厄贝沙坦氢氯噻嗪片，并列出进口/地产 150 mg/12.5 mg 片剂。这里仅建立中国药盒名称与准确规格的检索入口；美国 AVALIDE 档案另有 150/12.5 mg 和 300/12.5 mg 两种标签产品，不能仅按共同成分、品牌关联或 mg 数字跨市场合并、换算或替代。", "en": "The current Sanofi China product page maps CoAprovel® (安博诺®) to irbesartan/hydrochlorothiazide tablets and lists imported and locally produced 150 mg/12.5 mg tablets. This creates only a China pack-name and exact-strength search route. The U.S. AVALIDE dossier separately contains 150/12.5 mg and 300/12.5 mg labelled products; shared ingredients, brand association or milligram numbers do not merge, convert or substitute products across markets." }, "source": { "id": "src_dace9683647650ef", "label": "赛诺菲中国：安博诺® 厄贝沙坦氢氯噻嗪片当前产品页（150 mg/12.5 mg）", "url": "https://www.sanofi.cn/zh/your-health/products/coaprovel", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "first_party_product_page", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" } } ], "mainlandChinaTradeNameCue": { "value": "安博诺®", "status": "discovery_cue_requires_target_market_verification", "source": { "id": "src_dace9683647650ef", "label": "赛诺菲中国：安博诺® 厄贝沙坦氢氯噻嗪片当前产品页（150 mg/12.5 mg）", "url": "https://www.sanofi.cn/zh/your-health/products/coaprovel", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "first_party_product_page", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" } } }, "identity": { "therapeuticArea": "心血管", "sourceArchiveMarket": "美国：当前 DailyMed 公开标签所列 AVALIDE 薄膜衣口服片与两项准确 30 片瓶装展示面。中国大陆“安博诺®”只作为赛诺菲中国当前产品页约束的药盒名称与 150 mg/12.5 mg 片剂线索；不从任一市场资料推定另一市场的批准、包装、供应、购买资格、原研/仿制关系或可替代性。", "dosageFormClass": "厄贝沙坦/氢氯噻嗪固定组合薄膜衣口服片；所引美国标签展示 150 mg/12.5 mg 与 300 mg/12.5 mg 30 片瓶装", "dosageFormClassCode": "oral_solid", "route": "口服（产品身份字段）", "routeCode": "oral", "historicalApprovalEntry": "1997（所引美国标签列示 Initial U.S. Approval）", "archiveSponsorText": "Sanofi-Aventis U.S. LLC（所引美国 DailyMed 当前公开标签所列）" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [ "AVAPRO irbesartan single-ingredient tablet", "单方厄贝沙坦片", "another irbesartan/hydrochlorothiazide product", "其他厄贝沙坦/氢氯噻嗪产品", "other market package", "其他市场包装" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-avalide-irbesartan-hctz-150-12-5mg-30-bottle-ndc-0024-5855-30", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（2026-08-26 核验）", "en": "Current U.S. DailyMed public label (verified 26 Aug 2026)" }, "dosageForm": { "zh": "薄膜衣口服片", "en": "film-coated oral tablet" }, "route": { "zh": "口服（产品身份字段）", "en": "oral (product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 0024-5855-30", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "AVALIDE：每片厄贝沙坦 150 mg / 氢氯噻嗪 12.5 mg，30 片瓶装", "en": "AVALIDE: irbesartan 150 mg / hydrochlorothiazide 12.5 mg per tablet, 30-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=0d91895e-c869-4b33-9b83-d55c1ad6317e-09.jpg&setid=0d91895e-c869-4b33-9b83-d55c1ad6317e", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "厄贝沙坦（每片）", "en": "Irbesartan (per tablet)" }, "value": 150, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人剂量", "en": "Labelled amount per tablet; not an individual dose" } }, { "ingredient": { "zh": "氢氯噻嗪（每片）", "en": "Hydrochlorothiazide (per tablet)" }, "value": 12.5, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人剂量", "en": "Labelled amount per tablet; not an individual dose" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": null, "package": { "count": 30, "unit": { "zh": "片", "en": "tablets" } }, "physicalClues": { "color": { "zh": "桃色", "en": "peach" }, "shape": { "zh": "双凸椭圆形", "en": "biconvex oval" }, "imprint": { "zh": "一面心形图案；另一面 2875", "en": "heart on one side; 2875 on the other" }, "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_42edcc338c51a5ef", "label": "DailyMed (NLM): AVALIDE 150 mg/12.5 mg, NDC 0024-5855-30, 30-tablet bottle package panel", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=0d91895e-c869-4b33-9b83-d55c1ad6317e", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-26", "reviewedAt": "2026-08-26" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-avalide-irbesartan-hctz-300-12-5mg-30-bottle-ndc-0024-5856-30", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（2026-08-26 核验）", "en": "Current U.S. DailyMed public label (verified 26 Aug 2026)" }, "dosageForm": { "zh": "薄膜衣口服片", "en": "film-coated oral tablet" }, "route": { "zh": "口服（产品身份字段）", "en": "oral (product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 0024-5856-30", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "AVALIDE：每片厄贝沙坦 300 mg / 氢氯噻嗪 12.5 mg，30 片瓶装", "en": "AVALIDE: irbesartan 300 mg / hydrochlorothiazide 12.5 mg per tablet, 30-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=0d91895e-c869-4b33-9b83-d55c1ad6317e-10.jpg&setid=0d91895e-c869-4b33-9b83-d55c1ad6317e", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "厄贝沙坦（每片）", "en": "Irbesartan (per tablet)" }, "value": 300, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人剂量", "en": "Labelled amount per tablet; not an individual dose" } }, { "ingredient": { "zh": "氢氯噻嗪（每片）", "en": "Hydrochlorothiazide (per tablet)" }, "value": 12.5, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人剂量", "en": "Labelled amount per tablet; not an individual dose" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": null, "package": { "count": 30, "unit": { "zh": "片", "en": "tablets" } }, "physicalClues": { "color": { "zh": "桃色", "en": "peach" }, "shape": { "zh": "双凸椭圆形", "en": "biconvex oval" }, "imprint": { "zh": "一面心形图案；另一面 2876", "en": "heart on one side; 2876 on the other" }, "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_42edcc338c51a5ef", "label": "DailyMed (NLM): AVALIDE 300 mg/12.5 mg, NDC 0024-5856-30, 30-tablet bottle package panel", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=0d91895e-c869-4b33-9b83-d55c1ad6317e", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-26", "reviewedAt": "2026-08-26" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-avalide-irbesartan-hctz-150-12-5mg-30-bottle-ndc-0024-5855-30", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=0d91895e-c869-4b33-9b83-d55c1ad6317e-09.jpg&setid=0d91895e-c869-4b33-9b83-d55c1ad6317e", "alt": "AVALIDE 厄贝沙坦/氢氯噻嗪在美国 DailyMed 当前公开标签中的 150 mg/12.5 mg、NDC 0024-5855-30、30 片瓶装展示面", "archiveMarket": "美国", "labelVersion": "DailyMed 当前美国公开标签（2026-08-26 核验）", "presentation": "AVALIDE：每片厄贝沙坦 150 mg/氢氯噻嗪 12.5 mg，NDC 0024-5855-30，30 片瓶装展示面（当前 DailyMed 公开标签所列）。", "notice": "此图只对应所引美国 DailyMed 当前标签中的 AVALIDE、每片厄贝沙坦 150 mg/氢氯噻嗪 12.5 mg、NDC 0024-5855-30 与 30 片瓶装。它只帮助核对准确标签身份与来源；不用于鉴定真伪，也不证明其他强度、包装、市场、当前可得性、可替代性或任何人的用药方案。", "source": { "id": "src_42edcc338c51a5ef", "label": "DailyMed (NLM): current U.S. AVALIDE irbesartan/hydrochlorothiazide label (150 mg/12.5 mg, NDC 0024-5855-30 package panel)", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=0d91895e-c869-4b33-9b83-d55c1ad6317e", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-26", "reviewedAt": "2026-08-26" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "AVALIDE 说明书放大阅读：两组 mg 先是固定组合片的身份", "en": "AVALIDE label reading: two milligram values identify a fixed-combination tablet first" }, "summary": { "zh": "本模块用所引美国 DailyMed 当前公开标签核对 AVALIDE、厄贝沙坦/氢氯噻嗪、两种每片标示量、口服片、NDC、包装和外观。两组 mg 共同描述一片准确的固定组合产品；本页不从网页决定任何人的片数、开始、停用、替换、错开、联用或购买方案。", "en": "This module uses the cited current U.S. DailyMed public label to check AVALIDE, irbesartan/hydrochlorothiazide, two labelled amounts per tablet, oral-tablet form, NDC, pack and appearance. The two milligram values together describe one exact fixed-combination product; this page does not decide anyone's tablet count, start, stop, replacement, separation, co-use or purchase plan." }, "checks": [ { "zh": "先将 AVALIDE、两种活性成分、每片两组 mg、薄膜衣口服片、NDC、30 片瓶装、刻印和目标市场作为一组核对。150/12.5 与 300/12.5 不是网页上的个人剂量计算式，也不能据此把单方厄贝沙坦片、另一固定组合或另一市场包装当作可自行替换的同一产品。", "en": "Check AVALIDE, both active ingredients, both labelled milligram values per tablet, film-coated oral-tablet form, NDC, 30-tablet bottle, imprint and target market together. 150/12.5 and 300/12.5 are not web formulas for an individual dose and do not make a single-ingredient irbesartan tablet, another fixed combination or another-market pack self-replaceable." }, { "zh": "所引美国标签将两项展示面均描述为桃色双凸椭圆片，并以心形图案及 2875 或 2876 区分。颜色、形状、数字和照片只可协助定位候选标签；不能确认真伪、当前可得性、完整成分或可替代性。", "en": "The cited U.S. label describes both displayed presentations as peach biconvex oval tablets and distinguishes them with a heart plus 2875 or 2876. Colour, shape, numbers and a photograph can only help locate a candidate label; they cannot authenticate a product, confirm current availability, establish full ingredients or establish interchangeability." }, { "zh": "这是固定组合产品。若实际药盒、处方、药单、妊娠相关情况、既往反应或其他药物与网页记录不一致，应携带准确包装和完整药单请药师或开方团队按当前官方文件逐项核对；不要据本页自行加减、停用、叠加、拆分或替换。", "en": "This is a fixed-combination product. If the actual pack, prescription, medicine list, pregnancy-related circumstances, prior reactions or other medicines differ from the web record, bring the exact pack and complete medicine list to a pharmacist or prescriber for item-by-item review against current official documents; do not self-adjust, stop, stack, split or replace based on this page." }, { "zh": "出现呼吸困难、昏厥、面唇舌喉肿胀、严重皮疹或其他急性严重不适时，应优先使用当地紧急与医疗渠道；不要等待网页检索，也不要试图用另一盒药自行抵消或处理。", "en": "For breathing difficulty, fainting, swelling of the face, lips, tongue or throat, a severe rash or another acute serious concern, use local urgent and medical pathways first; do not wait for a web search or attempt to self-counteract or manage it with another pack." } ], "source": { "id": "src_42edcc338c51a5ef", "label": "DailyMed (NLM): current U.S. AVALIDE irbesartan/hydrochlorothiazide public label", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=0d91895e-c869-4b33-9b83-d55c1ad6317e", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-26", "reviewedAt": "2026-08-26" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "厄贝沙坦/氢氯噻嗪怎样起作用：固定组合的机制阅读，不是个人方案", "en": "How irbesartan/hydrochlorothiazide works: reading a fixed combination, not an individual plan" }, "summary": { "zh": "所引美国标签将 AVALIDE 描述为厄贝沙坦（血管紧张素 II 受体拮抗剂）和氢氯噻嗪（噻嗪类利尿剂）的固定组合。本段只解释标签对两种成分的分类；它不判断任何人的血压、体液状况、是否适用、片数、联用、暂停或替代。", "en": "The cited U.S. label describes AVALIDE as a fixed combination of irbesartan (an angiotensin II receptor antagonist) and hydrochlorothiazide (a thiazide diuretic). This section explains the label's classification of the two ingredients only; it does not determine anyone's blood pressure, fluid status, suitability, tablet count, co-use, pausing or substitution." }, "checks": [ { "zh": "“固定组合”意味着两种标签成分共同构成这一准确片剂身份；它不表示可把任意单方产品、其他品牌、其他强度或其他市场包装按网页自行凑成、拆开或换算成同一方案。", "en": "“Fixed combination” means two labelled ingredients together form this exact tablet identity; it does not mean arbitrary single-ingredient products, other brands, strengths or market packs can be self-assembled, separated or converted from a webpage into the same plan." }, { "zh": "“血管紧张素 II 受体拮抗剂”与“噻嗪类利尿剂”是作用路径分类，不足以解释个人头晕、血压读数、口渴、浮肿或其他症状的原因，也不替代专业人员对准确产品与完整药单的核对。", "en": "“Angiotensin II receptor antagonist” and “thiazide diuretic” are pathway classifications. They cannot explain the cause of an individual's dizziness, blood-pressure reading, thirst, swelling or another symptom, and they do not replace professional review of the exact product and complete medicine list." }, { "zh": "如担心同时使用的处方药、非处方药、补充剂、草本、既往反应或特殊生理情况，最有用的下一步是携带完整药单与实际药盒联系药师或医生；机制介绍不能替代这一核对。", "en": "For concerns about prescription products, OTC products, supplements, herbs, prior reactions or a special physiological circumstance, the most useful next step is to bring the complete medicine list and actual pack to a pharmacist or clinician; a mechanism introduction cannot replace that review." } ], "source": { "id": "src_42edcc338c51a5ef", "label": "DailyMed (NLM): current U.S. AVALIDE irbesartan/hydrochlorothiazide public label (Clinical Pharmacology)", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=0d91895e-c869-4b33-9b83-d55c1ad6317e", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-26", "reviewedAt": "2026-08-26" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "AVALIDE", "generic": "厄贝沙坦/氢氯噻嗪", "dosageFormClass": "厄贝沙坦/氢氯噻嗪固定组合薄膜衣口服片；所引美国标签展示 150 mg/12.5 mg 与 300 mg/12.5 mg 30 片瓶装" }, "labelSource": { "id": "src_42edcc338c51a5ef", "label": "DailyMed (NLM): current U.S. AVALIDE irbesartan/hydrochlorothiazide public label", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=0d91895e-c869-4b33-9b83-d55c1ad6317e", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-26", "reviewedAt": "2026-08-26" }, "productRoutes": [ { "source": { "id": "src_42edcc338c51a5ef", "label": "DailyMed (NLM): current U.S. AVALIDE irbesartan/hydrochlorothiazide public label", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=0d91895e-c869-4b33-9b83-d55c1ad6317e", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-26", "reviewedAt": "2026-08-26" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-26", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_022ec20a49fca6de", "label": "FDA Drugs@FDA: AVALIDE 2025 U.S. prescribing information PDF", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/020758s087lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-26", "reviewedAt": "2026-08-26" }, "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-08-26", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-26", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "这是一份美国 AVALIDE 的可追溯身份档案。所引 DailyMed 当前公开标签可核对 AVALIDE、厄贝沙坦/氢氯噻嗪、两种每片标示量、口服薄膜衣片、NDC、30 片瓶装、桃色椭圆外观和官方电子说明书。它帮助先辨认准确产品；不把两组 mg、瓶数、药名或照片变成个人服用片数、开始、停用、替换、联用或购买结论。", "history": "所引美国 DailyMed 当前公开标签列示 AVALIDE 的 Initial U.S. Approval 为 1997，并列 Sanofi-Aventis U.S. LLC。这里的时间和主体只锚定该美国公开标签；不据此断言其他市场的批准历史、当前供应、商标归属、原研身份、仿制关系或任何产品之间的相等性。", "sourceDocuments": [ { "id": "src_42edcc338c51a5ef", "label": "DailyMed (NLM): current U.S. AVALIDE irbesartan/hydrochlorothiazide public label", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=0d91895e-c869-4b33-9b83-d55c1ad6317e", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-26", "reviewedAt": "2026-08-26" }, { "id": "src_022ec20a49fca6de", "label": "FDA Drugs@FDA: AVALIDE 2025 U.S. prescribing information PDF", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/020758s087lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-26", "reviewedAt": "2026-08-26" } ], "applicationNumber": "NDA 020758", "approvalTimeline": [ { "date": "1997", "title": { "zh": "FDA 标签所列美国初始批准年份", "en": "Initial U.S. approval year listed in the FDA label" }, "detail": { "zh": "本页链接的 FDA 标签档案列示 Initial U.S. Approval: 1997。该历史定位不等同于当前批准、可得性、持有人或其他市场状态。", "en": "The FDA label archive linked here lists Initial U.S. Approval: 1997. This historical locator is not a conclusion about current approval, availability, holder or another market." }, "source": { "id": "src_42edcc338c51a5ef", "label": "DailyMed: AVALIDE current U.S. public label", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=0d91895e-c869-4b33-9b83-d55c1ad6317e", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-26", "reviewedAt": "2026-08-26" } }, { "date": "current DailyMed public label verified 2026-08-26", "title": { "zh": "FDA 标签档案版本", "en": "FDA label archive version" }, "detail": { "zh": "本页链接 current DailyMed public label verified 2026-08-26 的 FDA 标签档案作为可复核阅读入口。现行标签、规格、适应症和安全信息必须另行以目标市场当前文件核对。", "en": "This page links the current DailyMed public label verified 2026-08-26 FDA label archive as a traceable reading entry point. Current labeling, strength, indication and safety information require separate verification against the target market’s current document." }, "source": { "id": "src_42edcc338c51a5ef", "label": "DailyMed: AVALIDE current U.S. public label", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=0d91895e-c869-4b33-9b83-d55c1ad6317e", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-26", "reviewedAt": "2026-08-26" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "已链接公开标签档案", "en": "Public label archive linked" }, "detail": { "zh": "仅对应本页所列 FDA 文件。", "en": "Only the FDA document listed on this page is linked." } }, { "market": { "zh": "中国大陆、欧盟、日本", "en": "Mainland China, EU, Japan" }, "status": { "zh": "待逐项建立市场记录", "en": "Market record not established" }, "detail": { "zh": "不从美国标签档案推定当地批准、持有人、规格、供应或可售资格。", "en": "No local approval, holder, strength, supply or sale-eligibility conclusion is inferred from the U.S. label archive." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "标签档案能代表现在的产品信息吗？", "en": "Does a label archive represent current product information?" }, "answer": { "zh": "不能自动代表。档案用于定位来源；需要以目标市场的现行官方标签逐项复核。", "en": "Not automatically. The archive locates a source; each point needs verification against the target market’s current official label." } }, { "question": { "zh": "为什么这里不展示价格或原研/仿制结论？", "en": "Why are price and originator/generic conclusions not shown?" }, "answer": { "zh": "这些结论需要产品、剂型、规格、包装、市场、日期和原始记录分别齐全并经人工审核；单一标签文件不足以支持。", "en": "Those conclusions require separately complete and human-reviewed product, dosage-form, strength, pack, market, date and primary-record fields; one label file is insufficient." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "how-to-read-a-drug-label", "regulatory-sources-first" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/avalide/", "en": "https://origindrug.com/en/drugs/avalide/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "trexall", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-27", "status": "published_traceable_archive" }, "names": { "brand": "TREXALL", "generic": "甲氨蝶呤", "aliases": [ "Trexall", "methotrexate", "methotrexate sodium", "甲氨蝶呤", "甲氨蝶呤片", "51285-366-01", "51285-367-01", "51285-368-01", "51285-369-01", "927/5", "928/7½", "929/10", "945/15" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "免疫", "sourceArchiveMarket": "美国：DailyMed 当前 TREXALL 甲氨蝶呤薄膜衣口服片标签（SPL v14，2026-06-17 生效；ANDA 040385）。本页不从该美国文件推定中国大陆、欧盟、日本或其他市场的商品名、批准、供应、可售资格、包装或可替代性。", "dosageFormClass": "TREXALL 甲氨蝶呤薄膜衣口服片：5 mg、7.5 mg、10 mg、15 mg 每片；美国公开标签所列均为 30 片瓶装", "dosageFormClassCode": "oral_solid", "route": "口服（高风险准确产品身份字段）", "routeCode": "oral", "historicalApprovalEntry": "1999-10-29（FDA ANDA 040385 批准资料所列；不是 NDA 原研认定）", "archiveSponsorText": "Teva Women's Health LLC（DailyMed 当前美国公开标签所列包装方）" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [ "methotrexate injection", "甲氨蝶呤注射剂", "OTREXUP", "RASUVO", "REDI TREX", "another methotrexate tablet", "其他甲氨蝶呤片", "another market package", "其他市场包装" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-trexall-methotrexate-tablet-5mg-30-bottle-ndc-51285-366-01", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（2026-06-17 生效；2026-06-29 发布）", "en": "Current U.S. DailyMed public label (effective 17 Jun 2026; published 29 Jun 2026)" }, "dosageForm": { "zh": "TREXALL 甲氨蝶呤薄膜衣口服片", "en": "TREXALL methotrexate film-coated oral tablet" }, "route": { "zh": "口服（产品身份字段）", "en": "oral (product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 51285-366-01", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片甲氨蝶呤 5 mg；30 片瓶装", "en": "Methotrexate 5 mg per tablet; 30-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=e942f8db-510f-44d6-acb5-b822196f5e8c&name=image-2.jpg", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "甲氨蝶呤", "en": "methotrexate" }, "value": 5, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、频率、疗程或补服指令", "en": "labelled amount per tablet; not an individual's tablet count, frequency, course or missed-use instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-27", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 30, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "绿色", "en": "green" }, "shape": { "zh": "椭圆形、双凸、带刻痕薄膜衣片", "en": "oval, biconvex, scored film-coated tablet" }, "imprint": "stylized b / 927/5", "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_a399ca3551e73199", "label": "DailyMed（NLM）：TREXALL 甲氨蝶呤 5 mg、30 片瓶装美国公开标签面板", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=e942f8db-510f-44d6-acb5-b822196f5e8c", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-27", "reviewedAt": "2026-08-27" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-trexall-methotrexate-tablet-7-5mg-30-bottle-ndc-51285-367-01", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（2026-06-17 生效；2026-06-29 发布）", "en": "Current U.S. DailyMed public label (effective 17 Jun 2026; published 29 Jun 2026)" }, "dosageForm": { "zh": "TREXALL 甲氨蝶呤薄膜衣口服片", "en": "TREXALL methotrexate film-coated oral tablet" }, "route": { "zh": "口服（产品身份字段）", "en": "oral (product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 51285-367-01", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片甲氨蝶呤 7.5 mg；30 片瓶装", "en": "Methotrexate 7.5 mg per tablet; 30-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=e942f8db-510f-44d6-acb5-b822196f5e8c&name=image-3.jpg", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "甲氨蝶呤", "en": "methotrexate" }, "value": 7.5, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、频率、疗程或补服指令", "en": "labelled amount per tablet; not an individual's tablet count, frequency, course or missed-use instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-27", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 30, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "蓝色", "en": "blue" }, "shape": { "zh": "椭圆形、双凸、带刻痕薄膜衣片", "en": "oval, biconvex, scored film-coated tablet" }, "imprint": "stylized b / 928/7½", "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_a399ca3551e73199", "label": "DailyMed（NLM）：TREXALL 甲氨蝶呤 7.5 mg、30 片瓶装美国公开标签面板", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=e942f8db-510f-44d6-acb5-b822196f5e8c", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-27", "reviewedAt": "2026-08-27" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-trexall-methotrexate-tablet-10mg-30-bottle-ndc-51285-368-01", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（2026-06-17 生效；2026-06-29 发布）", "en": "Current U.S. DailyMed public label (effective 17 Jun 2026; published 29 Jun 2026)" }, "dosageForm": { "zh": "TREXALL 甲氨蝶呤薄膜衣口服片", "en": "TREXALL methotrexate film-coated oral tablet" }, "route": { "zh": "口服（产品身份字段）", "en": "oral (product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 51285-368-01", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片甲氨蝶呤 10 mg；30 片瓶装", "en": "Methotrexate 10 mg per tablet; 30-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=e942f8db-510f-44d6-acb5-b822196f5e8c&name=image-4.jpg", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "甲氨蝶呤", "en": "methotrexate" }, "value": 10, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、频率、疗程或补服指令", "en": "labelled amount per tablet; not an individual's tablet count, frequency, course or missed-use instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-27", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 30, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "粉红色", "en": "pink" }, "shape": { "zh": "椭圆形、双凸、带刻痕薄膜衣片", "en": "oval, biconvex, scored film-coated tablet" }, "imprint": "stylized b / 929/10", "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_a399ca3551e73199", "label": "DailyMed（NLM）：TREXALL 甲氨蝶呤 10 mg、30 片瓶装美国公开标签面板", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=e942f8db-510f-44d6-acb5-b822196f5e8c", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-27", "reviewedAt": "2026-08-27" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-trexall-methotrexate-tablet-15mg-30-bottle-ndc-51285-369-01", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（2026-06-17 生效；2026-06-29 发布）", "en": "Current U.S. DailyMed public label (effective 17 Jun 2026; published 29 Jun 2026)" }, "dosageForm": { "zh": "TREXALL 甲氨蝶呤薄膜衣口服片", "en": "TREXALL methotrexate film-coated oral tablet" }, "route": { "zh": "口服（产品身份字段）", "en": "oral (product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 51285-369-01", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片甲氨蝶呤 15 mg；30 片瓶装", "en": "Methotrexate 15 mg per tablet; 30-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=e942f8db-510f-44d6-acb5-b822196f5e8c&name=image-5.jpg", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "甲氨蝶呤", "en": "methotrexate" }, "value": 15, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、频率、疗程或补服指令", "en": "labelled amount per tablet; not an individual's tablet count, frequency, course or missed-use instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-27", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 30, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "紫色", "en": "purple" }, "shape": { "zh": "椭圆形、双凸、带刻痕薄膜衣片", "en": "oval, biconvex, scored film-coated tablet" }, "imprint": "stylized b / 945/15", "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_a399ca3551e73199", "label": "DailyMed（NLM）：TREXALL 甲氨蝶呤 15 mg、30 片瓶装美国公开标签面板", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=e942f8db-510f-44d6-acb5-b822196f5e8c", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-27", "reviewedAt": "2026-08-27" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-trexall-methotrexate-tablet-5mg-30-bottle-ndc-51285-366-01", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=e942f8db-510f-44d6-acb5-b822196f5e8c&name=image-2.jpg", "alt": "TREXALL 甲氨蝶呤 5 mg、NDC 51285-366-01、30 片瓶装的美国 DailyMed 当前标签展示面", "archiveMarket": "美国", "labelVersion": "DailyMed SPL v14（2026-06-17 生效；2026-06-29 发布）", "presentation": "TREXALL 甲氨蝶呤 5 mg、NDC 51285-366-01、30 片瓶装标签展示面。", "notice": "此图只对应所引美国 DailyMed 标签中的 TREXALL 5 mg、NDC 51285-366-01、30 片瓶装。它只帮助核对准确标签身份与来源；不用于鉴定真伪，不代表 7.5 mg、10 mg、15 mg、其他甲氨蝶呤产品、其他市场包装、当前可得性、原研身份、可替代性或任何人的用药方案。", "source": { "id": "src_a399ca3551e73199", "label": "DailyMed（NLM）：TREXALL 甲氨蝶呤 5 mg、NDC 51285-366-01、30 片瓶装当前美国标签面板", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=e942f8db-510f-44d6-acb5-b822196f5e8c", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-27", "reviewedAt": "2026-08-27" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "TREXALL 说明书放大阅读：先核对准确强度，再核对处方上的具体星期", "en": "TREXALL label reading: check the exact strength, then the specific day written on the prescription" }, "summary": { "zh": "这是一页高风险安全阅读。美国当前标签将 TREXALL 列为甲氨蝶呤口服片，并突出“用药错误风险”：对按每周一次开具的方案，误按每天服用已导致死亡。网页不计算个人频率；它只提醒把药盒、强度、处方和具体星期交给药师或开方团队逐项核对。", "en": "This is a higher-risk safety reading. The current U.S. label identifies TREXALL as an oral methotrexate tablet and highlights medication-error risk: where a once-weekly regimen was prescribed, mistaken daily use has led to fatal adverse reactions. The site does not calculate an individual's frequency; it prompts an item-by-item check of the pack, strength, prescription and named day with a pharmacist or prescriber." }, "checks": [ { "zh": "先同时核对 TREXALL、甲氨蝶呤、薄膜衣口服片、每片强度、NDC、30 片瓶装和目标市场。5、7.5、10、15 mg 是不同片剂的每片标示量；不是网页可以相加、换算、拆分或推导个人片数的数字。", "en": "Check TREXALL, methotrexate, film-coated oral-tablet form, strength per tablet, NDC, 30-tablet bottle and target market together. 5, 7.5, 10 and 15 mg identify different strengths per tablet; they are not numbers the site can add, convert, split or use to derive an individual's tablet count." }, { "zh": "标签警示必须与实际处方上的频率一起读。若处方写每周一次，应把具体星期写清并由专业人员确认；不要把“每周一次”误读成“每天一次”。若已经多服、连续多天服用或不确定，不要等待网页答复，应立即联系当地急救、毒物咨询或负责治疗团队。", "en": "The label warning must be read with the frequency on the actual prescription. If the prescription says once weekly, the specific day should be made explicit and confirmed by a professional; do not read once weekly as once daily. If extra doses were taken, use occurred on consecutive days, or there is uncertainty, do not wait for a web response—contact local emergency, poison-information or treating services immediately." }, { "zh": "标签列出的肿瘤、类风湿关节炎、幼年特发性关节炎和严重银屑病是美国标签用途范围，不表示看到相同疾病名称就适合使用，也不能据此决定频率、疗程或停用。", "en": "Cancer, rheumatoid arthritis, polyarticular juvenile idiopathic arthritis and severe psoriasis are indications in the U.S. label. Seeing a matching condition name does not establish suitability and cannot determine frequency, duration or stopping." }, { "zh": "甲氨蝶呤标签还涉及妊娠、严重过敏、骨髓、胃肠道、肝、肺、皮肤、肾脏及药物相互作用等重要风险。请让药师或开方团队结合实际处方、检验资料和完整药单核对；网页不会据此给出继续、暂停、补服或替代指令。", "en": "The methotrexate label also addresses pregnancy, severe hypersensitivity, bone-marrow, gastrointestinal, liver, lung, skin and kidney toxicity and drug interactions. Have a pharmacist or prescriber review the actual prescription, relevant tests and complete medicine list; the site does not turn these points into continuation, pausing, make-up use or substitution instructions." } ], "source": { "id": "src_a399ca3551e73199", "label": "DailyMed（NLM）：TREXALL 甲氨蝶呤当前美国公开标签（盒装警示、5.9 用药错误风险与患者信息）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=e942f8db-510f-44d6-acb5-b822196f5e8c", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-27", "reviewedAt": "2026-08-27" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "甲氨蝶呤怎样起作用：抑制二氢叶酸还原酶（机制说明，不是个人频率）", "en": "How methotrexate works: inhibition of dihydrofolate reductase (a mechanism, not an individual schedule)" }, "summary": { "zh": "美国当前标签说明，甲氨蝶呤抑制二氢叶酸还原酶，进而干扰嘌呤核苷酸和胸苷酸相关过程以及 DNA 合成、修复和细胞复制；同一标签也明确写明其在类风湿关节炎和银屑病中的作用机制尚不清楚。机制不能用来推导任何人的片数、星期、疗程、监测、联用或替代。", "en": "The current U.S. label says methotrexate inhibits dihydrofolate reductase, thereby interfering with pathways involving purine nucleotides and thymidylate and with DNA synthesis, repair and cellular replication; the same label states that its mechanism in rheumatoid arthritis and psoriasis is unknown. A mechanism cannot determine anyone's tablet count, day, duration, monitoring, co-use or substitution." }, "checks": [ { "zh": "“抑制二氢叶酸还原酶”解释的是作用路径，不表示可以从叶酸、症状、疾病名称或一次检验结果自行决定加减、漏服处理、停用或恢复。", "en": "“Inhibits dihydrofolate reductase” describes a pathway; it does not allow folate use, symptoms, a condition name or one test result to determine an increase, decrease, missed-use action, stop or restart." }, { "zh": "标签指出增殖活跃的组织可能更敏感，这有助于理解为什么需要严密监测；它不能由网页转化成个人风险预测，也不能解释某个具体症状的原因。", "en": "The label notes that actively proliferating tissues may be more sensitive. This helps explain why close monitoring matters, but it cannot be converted by a website into an individual risk prediction or an explanation for a specific symptom." }, { "zh": "不同甲氨蝶呤产品可能有不同剂型、浓度、装置、市场标签和频率。共同成分或相同毫克数不建立自动互换；应把准确药盒、处方和完整药单交给专业人员核对。", "en": "Methotrexate products can differ in dosage form, concentration, device, market label and schedule. A shared ingredient or matching milligram number does not establish automatic interchangeability; have a professional review the exact pack, prescription and complete medicine list." } ], "source": { "id": "src_a399ca3551e73199", "label": "DailyMed（NLM）：TREXALL 当前美国公开标签（12.1 Mechanism of Action）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=e942f8db-510f-44d6-acb5-b822196f5e8c", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-27", "reviewedAt": "2026-08-27" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "TREXALL", "generic": "甲氨蝶呤", "dosageFormClass": "TREXALL 甲氨蝶呤薄膜衣口服片：5 mg、7.5 mg、10 mg、15 mg 每片；美国公开标签所列均为 30 片瓶装" }, "labelSource": { "id": "src_a399ca3551e73199", "label": "DailyMed（NLM）：TREXALL 甲氨蝶呤当前美国公开标签（Teva Women's Health；SPL v14）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=e942f8db-510f-44d6-acb5-b822196f5e8c", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-27", "reviewedAt": "2026-08-27" }, "productRoutes": [ { "source": { "id": "src_a399ca3551e73199", "label": "DailyMed（NLM）：TREXALL 甲氨蝶呤当前美国公开标签（Teva Women's Health；SPL v14）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=e942f8db-510f-44d6-acb5-b822196f5e8c", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-27", "reviewedAt": "2026-08-27" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-27", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_dacb1405745102d9", "label": "FDA：Methotrexate Sodium Tablets / TREXALL ANDA 040385 批准资料（1999-10-29）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/040385_S000_TREXALL%20TABLETS%20_ORIGINAL.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-27", "reviewedAt": "2026-08-27" }, "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-08-27", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-27", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "TREXALL 是美国当前公开标签中的甲氨蝶呤薄膜衣口服片，列有 5 mg、7.5 mg、10 mg、15 mg 四种每片强度和四个 30 片瓶装 NDC。它是高风险用药档案：标签警示，对按每周一次开具的方案，误把每周用量按每天服用已导致致命不良反应。网页不提供任何人的片数、日期、漏服、加减、停用或替代方案；若已经多服、误按每天服用或不确定，应立即联系当地急救、毒物咨询或负责治疗团队，并带上药盒与处方。", "history": "FDA 批准资料记录 Methotrexate Sodium Tablets / TREXALL 对应 ANDA 040385，批准日期为 1999-10-29；DailyMed 当前标签另列活性成分的 Initial U.S. Approval 为 1953。两者不是同一含义：前者定位该申请与品牌记录，后者是标签中的活性成分历史字段。页面不会把 1953、品牌名或包装图转换成 TREXALL 的原研认定。", "sourceDocuments": [ { "id": "src_a399ca3551e73199", "label": "DailyMed（NLM）：TREXALL 甲氨蝶呤当前美国公开标签（Teva Women's Health；SPL v14）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=e942f8db-510f-44d6-acb5-b822196f5e8c", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-27", "reviewedAt": "2026-08-27" }, { "id": "src_dacb1405745102d9", "label": "FDA：Methotrexate Sodium Tablets / TREXALL ANDA 040385 批准资料（1999-10-29）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/040385_S000_TREXALL%20TABLETS%20_ORIGINAL.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-27", "reviewedAt": "2026-08-27" } ], "applicationNumber": "ANDA 040385（DailyMed 当前标签与 FDA 批准资料所列；不作为原研认定）", "approvalTimeline": [ { "date": "1999-10-29", "title": { "zh": "FDA ANDA 040385 批准资料", "en": "FDA ANDA 040385 approval record" }, "detail": { "zh": "FDA 公开批准资料将 Methotrexate Sodium Tablets / TREXALL 与 ANDA 040385、1999-10-29 批准日期相连。ANDA 是简略新药申请；本页因此不把该记录写成 NDA 原研批准，也不由品牌名推定原研身份。", "en": "The public FDA approval record links Methotrexate Sodium Tablets / TREXALL to ANDA 040385 and the approval date 29 Oct 1999. ANDA is an Abbreviated New Drug Application; this page therefore does not describe the record as an NDA originator approval or infer originator status from the brand name." }, "source": { "id": "src_dacb1405745102d9", "label": "FDA：Methotrexate Sodium Tablets / TREXALL ANDA 040385 批准资料（1999-10-29）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/040385_S000_TREXALL%20TABLETS%20_ORIGINAL.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-27", "reviewedAt": "2026-08-27" } }, { "date": "2026-06-17", "title": { "zh": "DailyMed SPL v14 生效：用药错误风险警示更新", "en": "DailyMed SPL v14 effective: medication-error warning updated" }, "detail": { "zh": "当前公开标签列出四种强度、四个 30 片瓶装 NDC，并在盒装警示及 5.9 节强调：对按每周一次开具的方案，误按每天服用甲氨蝶呤片已导致死亡。该日期定位文件版本，不是任何人的用药频率。", "en": "The current public label lists four strengths and four 30-tablet bottle NDCs and emphasises in the boxed warning and section 5.9 that, where once-weekly use was prescribed, mistaken daily administration of methotrexate tablets has resulted in death. This date identifies a document version, not anyone's schedule." }, "source": { "id": "src_a399ca3551e73199", "label": "DailyMed（NLM）：TREXALL 甲氨蝶呤当前美国公开标签（SPL v14）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=e942f8db-510f-44d6-acb5-b822196f5e8c", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-27", "reviewedAt": "2026-08-27" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "已链接当前 ANDA 品牌标签、四种准确强度与四个包装面板", "en": "Current ANDA brand label, four exact strengths and four package panels linked" }, "detail": { "zh": "本页分别记录 TREXALL 5 mg、7.5 mg、10 mg、15 mg 薄膜衣口服片的 NDC 与 30 片瓶装面板，并明示 ANDA 040385。它用于产品身份和安全阅读，不用于鉴定真伪，也不建立当前供应、库存、购买、个人片数、频率、停用、换药或原研身份。", "en": "This page separately records the NDC and 30-tablet bottle panel for TREXALL 5 mg, 7.5 mg, 10 mg and 15 mg film-coated oral tablets and explicitly identifies ANDA 040385. It supports product identity and safety reading; it does not authenticate a product or establish current supply, stock, purchase, individual tablet count, frequency, stopping, switching or originator status." } }, { "market": { "zh": "中国大陆、欧盟、日本及其他市场", "en": "Mainland China, the EU, Japan and other markets" }, "status": { "zh": "待逐项建立现行市场记录", "en": "Current market record not established" }, "detail": { "zh": "不从美国 ANDA、DailyMed 名称、NDC、标签警示、每片强度或包装图推定当地商品名、批准、包装、供应、可售资格、原研/仿制关系或可替代性；每个市场均须按当地现行监管资料单独核对。", "en": "No local trade name, approval, packaging, supply, sale eligibility, originator/generic relationship or interchangeability is inferred from the U.S. ANDA, DailyMed name, NDC, label warning, strength per tablet or package image; each market requires separate review against current local regulatory material." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "看到 TREXALL 包装上的 5、7.5、10 或 15 mg，能否算出我该吃几片、哪一天吃？", "en": "Can the 5, 7.5, 10 or 15 mg on a TREXALL pack tell me how many tablets to take or on which day?" }, "answer": { "zh": "不能。这些数字只识别每片标示强度。频率、具体星期和片数必须来自实际处方并由开方团队或药师确认。若已经多服、把每周一次误作每天一次、连续多天服用或不确定，应立即联系当地急救、毒物咨询或负责治疗团队，不要等待网页答复。", "en": "No. These numbers identify labelled strength per tablet only. Frequency, named day and tablet count must come from the actual prescription and be confirmed by the prescriber or pharmacist. If extra doses were taken, once-weekly use was mistaken for daily use, use occurred on consecutive days, or there is uncertainty, contact local emergency, poison-information or treating services immediately rather than waiting for a web response." } }, { "question": { "zh": "TREXALL 是原研药吗？", "en": "Is TREXALL an originator medicine?" }, "answer": { "zh": "本页不把它标为美国原研药。当前 DailyMed 标签明确列出 ANDA040385，FDA 批准资料也对应 ANDA 040385；这是该美国品牌甲氨蝶呤片的可追溯申请与标签身份。原研/仿制关系必须按目标市场、准确产品和监管申请逐项核对，不能只看品牌名。", "en": "This page does not label it as a U.S. originator medicine. The current DailyMed label explicitly lists ANDA040385, and the FDA approval record also corresponds to ANDA 040385; this is the traceable application and label identity for the U.S. branded methotrexate tablet. Originator/generic relationships require exact product-, market- and application-level review and cannot be inferred from a brand name alone." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "dosage-forms-are-part-of-medicine-identity", "how-to-read-a-drug-label" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/trexall/", "en": "https://origindrug.com/en/drugs/trexall/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "stalevo", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-27", "status": "published_traceable_archive" }, "names": { "brand": "STALEVO", "generic": "卡比多巴/左旋多巴/恩他卡朋（复方）", "aliases": [ "Stalevo", "carbidopa levodopa entacapone", "carbidopa/levodopa/entacapone", "卡比多巴 左旋多巴 恩他卡朋", "卡比多巴/左旋多巴/恩他卡朋", "息宁 恩他卡朋", "STALEVO 50", "STALEVO 75", "STALEVO 100", "STALEVO 125", "STALEVO 150", "STALEVO 200", "52427-805-01", "52427-809-01", "52427-816-01", "52427-827-01", "52427-834-01", "52427-842-01", "LCE 50", "LCE 75", "LCE 100", "LCE 125", "LCE 150", "LCE 200" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "神经与认知", "sourceArchiveMarket": "美国：DailyMed 当前 STALEVO 卡比多巴/左旋多巴/恩他卡朋薄膜衣口服片标签（SPL v8，2026-03-27 生效；NDA 021485）。本页不从美国文件推定中国大陆、欧盟、日本或其他市场的商品名、批准、供应、包装、可售资格或可替代性。", "dosageFormClass": "STALEVO 固定三成分薄膜衣口服片：50、75、100、125、150、200 六种名称强度；每片分别含卡比多巴/左旋多巴，并固定含恩他卡朋 200 mg；美国标签所列均为 100 片瓶装", "dosageFormClassCode": "oral_solid", "route": "口服（高风险固定三成分产品身份字段）", "routeCode": "oral", "historicalApprovalEntry": "2003-06-11（FDA NDA 021485 原始申请批准记录）", "archiveSponsorText": "Almatica Pharma LLC（DailyMed 当前美国公开标签所列经销方；Orion Corporation 为产品来源方）" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [ "SINEMET", "carbidopa and levodopa only", "卡比多巴/左旋多巴二成分片", "entacapone tablet", "恩他卡朋单方片", "extended-release carbidopa/levodopa", "卡比多巴左旋多巴缓释片", "another-market STALEVO pack", "其他市场 STALEVO 包装" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-stalevo-50-carbidopa-12-5mg-levodopa-50mg-entacapone-200mg-100-bottle-ndc-52427-805-01", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（SPL v8，2026-03-27 生效；包装面板标注 Rev. 06/2021）", "en": "Current U.S. DailyMed public label (SPL v8, effective 27 Mar 2026; package panel marked Rev. 06/2021)" }, "dosageForm": { "zh": "STALEVO 卡比多巴/左旋多巴/恩他卡朋薄膜衣口服片", "en": "STALEVO carbidopa/levodopa/entacapone film-coated oral tablet" }, "route": { "zh": "口服（固定三成分产品身份字段）", "en": "oral (fixed three-ingredient product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 52427-805-01", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "STALEVO 50：每片卡比多巴 12.5 mg / 左旋多巴 50 mg / 恩他卡朋 200 mg；100 片瓶装", "en": "STALEVO 50: carbidopa 12.5 mg / levodopa 50 mg / entacapone 200 mg per tablet; 100-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=stalevo50.jpg&archiveid=955349", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "卡比多巴", "en": "carbidopa" }, "value": 12.5, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片第一种标签成分；不是个人剂量或换算指令", "en": "first labelled ingredient per tablet; not an individual dose or conversion instruction" } }, { "ingredient": { "zh": "左旋多巴", "en": "levodopa" }, "value": 50, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片第二种标签成分；不是个人剂量或换算指令", "en": "second labelled ingredient per tablet; not an individual dose or conversion instruction" } }, { "ingredient": { "zh": "恩他卡朋", "en": "entacapone" }, "value": 200, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片第三种标签成分；六种强度均为 200 mg，不能靠多片或分片自行凑数", "en": "third labelled ingredient per tablet; all six strengths contain 200 mg, so multiple tablets or tablet portions must not be self-combined" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "HDPE 瓶", "en": "HDPE bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-27", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "棕红色或灰红色", "en": "brownish-red or greyish-red" }, "shape": { "zh": "圆形、双凸、无刻痕薄膜衣片", "en": "round, biconvex, unscored film-coated tablet" }, "imprint": "LCE 50", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_b7f41b68bad71874", "label": "DailyMed（NLM）：STALEVO 50，12.5/50/200 mg、100 片瓶装美国公开标签面板", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=53c488d8-4146-7563-8021-d90c931d1a95", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-27", "reviewedAt": "2026-08-27" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-stalevo-75-carbidopa-18-75mg-levodopa-75mg-entacapone-200mg-100-bottle-ndc-52427-809-01", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（SPL v8，2026-03-27 生效；包装面板标注 Rev. 06/2021）", "en": "Current U.S. DailyMed public label (SPL v8, effective 27 Mar 2026; package panel marked Rev. 06/2021)" }, "dosageForm": { "zh": "STALEVO 卡比多巴/左旋多巴/恩他卡朋薄膜衣口服片", "en": "STALEVO carbidopa/levodopa/entacapone film-coated oral tablet" }, "route": { "zh": "口服（固定三成分产品身份字段）", "en": "oral (fixed three-ingredient product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 52427-809-01", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "STALEVO 75：每片卡比多巴 18.75 mg / 左旋多巴 75 mg / 恩他卡朋 200 mg；100 片瓶装", "en": "STALEVO 75: carbidopa 18.75 mg / levodopa 75 mg / entacapone 200 mg per tablet; 100-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=stalevo75.jpg&archiveid=955349", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "卡比多巴", "en": "carbidopa" }, "value": 18.75, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片第一种标签成分；不是个人剂量或换算指令", "en": "first labelled ingredient per tablet; not an individual dose or conversion instruction" } }, { "ingredient": { "zh": "左旋多巴", "en": "levodopa" }, "value": 75, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片第二种标签成分；不是个人剂量或换算指令", "en": "second labelled ingredient per tablet; not an individual dose or conversion instruction" } }, { "ingredient": { "zh": "恩他卡朋", "en": "entacapone" }, "value": 200, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片第三种标签成分；六种强度均为 200 mg，不能靠多片或分片自行凑数", "en": "third labelled ingredient per tablet; all six strengths contain 200 mg, so multiple tablets or tablet portions must not be self-combined" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "HDPE 瓶", "en": "HDPE bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-27", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "浅棕红色", "en": "light brownish-red" }, "shape": { "zh": "椭圆形、无刻痕薄膜衣片", "en": "oval, unscored film-coated tablet" }, "imprint": "LCE 75", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_b7f41b68bad71874", "label": "DailyMed（NLM）：STALEVO 75，18.75/75/200 mg、100 片瓶装美国公开标签面板", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=53c488d8-4146-7563-8021-d90c931d1a95", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-27", "reviewedAt": "2026-08-27" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-stalevo-100-carbidopa-25mg-levodopa-100mg-entacapone-200mg-100-bottle-ndc-52427-816-01", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（SPL v8，2026-03-27 生效；包装面板标注 Rev. 06/2021）", "en": "Current U.S. DailyMed public label (SPL v8, effective 27 Mar 2026; package panel marked Rev. 06/2021)" }, "dosageForm": { "zh": "STALEVO 卡比多巴/左旋多巴/恩他卡朋薄膜衣口服片", "en": "STALEVO carbidopa/levodopa/entacapone film-coated oral tablet" }, "route": { "zh": "口服（固定三成分产品身份字段）", "en": "oral (fixed three-ingredient product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 52427-816-01", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "STALEVO 100：每片卡比多巴 25 mg / 左旋多巴 100 mg / 恩他卡朋 200 mg；100 片瓶装", "en": "STALEVO 100: carbidopa 25 mg / levodopa 100 mg / entacapone 200 mg per tablet; 100-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=stalevo100.jpg&archiveid=955349", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "卡比多巴", "en": "carbidopa" }, "value": 25, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片第一种标签成分；不是个人剂量或换算指令", "en": "first labelled ingredient per tablet; not an individual dose or conversion instruction" } }, { "ingredient": { "zh": "左旋多巴", "en": "levodopa" }, "value": 100, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片第二种标签成分；不是个人剂量或换算指令", "en": "second labelled ingredient per tablet; not an individual dose or conversion instruction" } }, { "ingredient": { "zh": "恩他卡朋", "en": "entacapone" }, "value": 200, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片第三种标签成分；六种强度均为 200 mg，不能靠多片或分片自行凑数", "en": "third labelled ingredient per tablet; all six strengths contain 200 mg, so multiple tablets or tablet portions must not be self-combined" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "HDPE 瓶", "en": "HDPE bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-27", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "棕红色或灰红色", "en": "brownish-red or greyish-red" }, "shape": { "zh": "椭圆形、无刻痕薄膜衣片", "en": "oval, unscored film-coated tablet" }, "imprint": "LCE 100", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_b7f41b68bad71874", "label": "DailyMed（NLM）：STALEVO 100，25/100/200 mg、100 片瓶装美国公开标签面板", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=53c488d8-4146-7563-8021-d90c931d1a95", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-27", "reviewedAt": "2026-08-27" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-stalevo-125-carbidopa-31-25mg-levodopa-125mg-entacapone-200mg-100-bottle-ndc-52427-827-01", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（SPL v8，2026-03-27 生效；包装面板标注 Rev. 06/2021）", "en": "Current U.S. DailyMed public label (SPL v8, effective 27 Mar 2026; package panel marked Rev. 06/2021)" }, "dosageForm": { "zh": "STALEVO 卡比多巴/左旋多巴/恩他卡朋薄膜衣口服片", "en": "STALEVO carbidopa/levodopa/entacapone film-coated oral tablet" }, "route": { "zh": "口服（固定三成分产品身份字段）", "en": "oral (fixed three-ingredient product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 52427-827-01", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "STALEVO 125：每片卡比多巴 31.25 mg / 左旋多巴 125 mg / 恩他卡朋 200 mg；100 片瓶装", "en": "STALEVO 125: carbidopa 31.25 mg / levodopa 125 mg / entacapone 200 mg per tablet; 100-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=stalevo125.jpg&archiveid=955349", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "卡比多巴", "en": "carbidopa" }, "value": 31.25, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片第一种标签成分；不是个人剂量或换算指令", "en": "first labelled ingredient per tablet; not an individual dose or conversion instruction" } }, { "ingredient": { "zh": "左旋多巴", "en": "levodopa" }, "value": 125, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片第二种标签成分；不是个人剂量或换算指令", "en": "second labelled ingredient per tablet; not an individual dose or conversion instruction" } }, { "ingredient": { "zh": "恩他卡朋", "en": "entacapone" }, "value": 200, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片第三种标签成分；六种强度均为 200 mg，不能靠多片或分片自行凑数", "en": "third labelled ingredient per tablet; all six strengths contain 200 mg, so multiple tablets or tablet portions must not be self-combined" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "HDPE 瓶", "en": "HDPE bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-27", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "浅棕红色", "en": "light brownish-red" }, "shape": { "zh": "椭圆形、无刻痕薄膜衣片", "en": "oval, unscored film-coated tablet" }, "imprint": "LCE 125", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_b7f41b68bad71874", "label": "DailyMed（NLM）：STALEVO 125，31.25/125/200 mg、100 片瓶装美国公开标签面板", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=53c488d8-4146-7563-8021-d90c931d1a95", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-27", "reviewedAt": "2026-08-27" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-stalevo-150-carbidopa-37-5mg-levodopa-150mg-entacapone-200mg-100-bottle-ndc-52427-834-01", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（SPL v8，2026-03-27 生效；包装面板标注 Rev. 06/2021）", "en": "Current U.S. DailyMed public label (SPL v8, effective 27 Mar 2026; package panel marked Rev. 06/2021)" }, "dosageForm": { "zh": "STALEVO 卡比多巴/左旋多巴/恩他卡朋薄膜衣口服片", "en": "STALEVO carbidopa/levodopa/entacapone film-coated oral tablet" }, "route": { "zh": "口服（固定三成分产品身份字段）", "en": "oral (fixed three-ingredient product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 52427-834-01", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "STALEVO 150：每片卡比多巴 37.5 mg / 左旋多巴 150 mg / 恩他卡朋 200 mg；100 片瓶装", "en": "STALEVO 150: carbidopa 37.5 mg / levodopa 150 mg / entacapone 200 mg per tablet; 100-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=stalevo150.jpg&archiveid=955349", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "卡比多巴", "en": "carbidopa" }, "value": 37.5, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片第一种标签成分；不是个人剂量或换算指令", "en": "first labelled ingredient per tablet; not an individual dose or conversion instruction" } }, { "ingredient": { "zh": "左旋多巴", "en": "levodopa" }, "value": 150, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片第二种标签成分；不是个人剂量或换算指令", "en": "second labelled ingredient per tablet; not an individual dose or conversion instruction" } }, { "ingredient": { "zh": "恩他卡朋", "en": "entacapone" }, "value": 200, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片第三种标签成分；六种强度均为 200 mg，不能靠多片或分片自行凑数", "en": "third labelled ingredient per tablet; all six strengths contain 200 mg, so multiple tablets or tablet portions must not be self-combined" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "HDPE 瓶", "en": "HDPE bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-27", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "棕红色或灰红色", "en": "brownish-red or greyish-red" }, "shape": { "zh": "长椭圆形、无刻痕薄膜衣片", "en": "elongated oval, unscored film-coated tablet" }, "imprint": "LCE 150", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_b7f41b68bad71874", "label": "DailyMed（NLM）：STALEVO 150，37.5/150/200 mg、100 片瓶装美国公开标签面板", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=53c488d8-4146-7563-8021-d90c931d1a95", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-27", "reviewedAt": "2026-08-27" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-stalevo-200-carbidopa-50mg-levodopa-200mg-entacapone-200mg-100-bottle-ndc-52427-842-01", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（SPL v8，2026-03-27 生效；包装面板标注 Rev. 06/2021）", "en": "Current U.S. DailyMed public label (SPL v8, effective 27 Mar 2026; package panel marked Rev. 06/2021)" }, "dosageForm": { "zh": "STALEVO 卡比多巴/左旋多巴/恩他卡朋薄膜衣口服片", "en": "STALEVO carbidopa/levodopa/entacapone film-coated oral tablet" }, "route": { "zh": "口服（固定三成分产品身份字段）", "en": "oral (fixed three-ingredient product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 52427-842-01", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "STALEVO 200：每片卡比多巴 50 mg / 左旋多巴 200 mg / 恩他卡朋 200 mg；100 片瓶装", "en": "STALEVO 200: carbidopa 50 mg / levodopa 200 mg / entacapone 200 mg per tablet; 100-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=stalevo200.jpg&archiveid=955349", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "卡比多巴", "en": "carbidopa" }, "value": 50, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片第一种标签成分；不是个人剂量或换算指令", "en": "first labelled ingredient per tablet; not an individual dose or conversion instruction" } }, { "ingredient": { "zh": "左旋多巴", "en": "levodopa" }, "value": 200, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片第二种标签成分；不是个人剂量或换算指令", "en": "second labelled ingredient per tablet; not an individual dose or conversion instruction" } }, { "ingredient": { "zh": "恩他卡朋", "en": "entacapone" }, "value": 200, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片第三种标签成分；六种强度均为 200 mg，不能靠多片或分片自行凑数", "en": "third labelled ingredient per tablet; all six strengths contain 200 mg, so multiple tablets or tablet portions must not be self-combined" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "HDPE 瓶", "en": "HDPE bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-27", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "深棕红色", "en": "dark brownish-red" }, "shape": { "zh": "椭圆形、无刻痕薄膜衣片", "en": "oval, unscored film-coated tablet" }, "imprint": "LCE 200", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_b7f41b68bad71874", "label": "DailyMed（NLM）：STALEVO 200，50/200/200 mg、100 片瓶装美国公开标签面板", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=53c488d8-4146-7563-8021-d90c931d1a95", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-27", "reviewedAt": "2026-08-27" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-stalevo-50-carbidopa-12-5mg-levodopa-50mg-entacapone-200mg-100-bottle-ndc-52427-805-01", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=stalevo50.jpg&archiveid=955349", "alt": "STALEVO 50 卡比多巴 12.5 mg／左旋多巴 50 mg／恩他卡朋 200 mg、NDC 52427-805-01、100 片瓶装的美国 DailyMed 标签展示面", "archiveMarket": "美国", "labelVersion": "DailyMed 当前标签 SPL v8（2026-03-27 生效）；包装面板标注 Rev. 06/2021", "presentation": "STALEVO 50：每片卡比多巴 12.5 mg / 左旋多巴 50 mg / 恩他卡朋 200 mg，NDC 52427-805-01，100 片瓶装标签展示面。", "notice": "此图只对应所引美国 DailyMed 标签中的 STALEVO 50、三种每片成分量、NDC 52427-805-01 与 100 片瓶装。它不代表 STALEVO 75/100/125/150/200、SINEMET、恩他卡朋单方、其他市场包装或当前可得性；不用于鉴定真伪，也不生成个人片数、间隔、分片、压碎、换药或停药方案。", "source": { "id": "src_b7f41b68bad71874", "label": "DailyMed（NLM）：STALEVO 50，12.5/50/200 mg、NDC 52427-805-01、100 片瓶装标签面板", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=53c488d8-4146-7563-8021-d90c931d1a95", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-27", "reviewedAt": "2026-08-27" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "STALEVO 说明书放大阅读：三个数字属于同一片，六种强度都含恩他卡朋 200 mg", "en": "STALEVO label reading: three numbers belong to one tablet, and every strength contains entacapone 200 mg" }, "summary": { "zh": "STALEVO 是三成分固定复方，不是单一左旋多巴片。美国当前标签明确要求整片使用，不可掰开、压碎或咀嚼；同一给药间隔只使用一片。六种强度每片都含恩他卡朋 200 mg，靠多片或部分片剂凑更高左旋多巴量可能导致恩他卡朋过量。网页不据此安排个人片数、时间或转换。", "en": "STALEVO is a fixed three-ingredient combination, not a levodopa-only tablet. The current U.S. label says tablets must not be split, crushed or chewed and only one tablet is administered at each dosing interval. Every strength contains entacapone 200 mg; combining tablets or tablet portions to obtain more levodopa may cause entacapone overdose. The site does not turn this into an individual tablet count, schedule or conversion." }, "checks": [ { "zh": "先同时核对 STALEVO 名称、卡比多巴/左旋多巴/恩他卡朋三种成分、三组每片 mg、NDC、100 片瓶装、LCE 刻印与目标市场。STALEVO 100 的“100”只对应左旋多巴这一组名称强度；整片仍含卡比多巴 25 mg 和恩他卡朋 200 mg。", "en": "Check STALEVO, all three ingredients, all three milligram amounts per tablet, NDC, 100-tablet bottle, LCE imprint and market together. The '100' in STALEVO 100 names the levodopa component only; the same tablet also contains carbidopa 25 mg and entacapone 200 mg." }, { "zh": "不要把 STALEVO 当成 SINEMET 的另一种包装。两者可能都写卡比多巴/左旋多巴，但 STALEVO 还含恩他卡朋；共同成分、相近数字或相似用途不能建立自行同服、轮换、替换或叠加关系。请把两盒实际药和完整药单交给药师或开方团队核对。", "en": "Do not treat STALEVO as another SINEMET pack. Both may name carbidopa/levodopa, but STALEVO also contains entacapone. Shared ingredients, nearby numbers or a similar purpose do not establish self-co-use, alternation, substitution or stacking. Have a pharmacist or prescriber review both actual packs and the complete medicine list." }, { "zh": "当前标签还涉及突然停用后的高热与意识混乱、日常活动中突然入睡、直立性低血压、异动症、幻觉、冲动控制、腹泻及与华法林等药物相互作用。网页只提示把症状、跌倒、嗜睡和完整药单带去核对，不给出自行停用、减量、补服或错开方案。", "en": "The current label also addresses hyperpyrexia and confusion after abrupt reduction or withdrawal, falling asleep during daily activities, orthostatic hypotension, dyskinesia, hallucinations, impulse-control problems, diarrhoea and interactions including warfarin. The site only prompts review of symptoms, falls, sleepiness and the complete medicine list; it does not provide self-stopping, reduction, make-up or spacing instructions." }, { "zh": "若出现意识丧失、严重跌倒、呼吸困难、明显意识混乱、高热、疑似过量或其他急性严重情况，应立即使用当地急救或毒物咨询渠道，并带上全部药盒；不要等待网页检索或自行用另一种帕金森药抵消。", "en": "For loss of consciousness, a serious fall, breathing difficulty, marked confusion, high fever, suspected overdose or another acute serious concern, use local emergency or poison-information services immediately and bring all medicine packs; do not wait for a web search or try to counteract it with another Parkinson medicine." } ], "source": { "id": "src_b7f41b68bad71874", "label": "DailyMed（NLM）：STALEVO 当前美国公开标签（2.7 重要用法、5 警告与相互作用）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=53c488d8-4146-7563-8021-d90c931d1a95", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-27", "reviewedAt": "2026-08-27" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "三种成分怎样配合：左旋多巴进入脑内转化，多巴脱羧酶与 COMT 通路在外周被抑制", "en": "How the three ingredients work together: levodopa reaches the brain while peripheral decarboxylase and COMT pathways are inhibited" }, "summary": { "zh": "美国当前标签说明，左旋多巴可通过血脑屏障并在脑内转化为多巴胺；卡比多巴抑制外周左旋多巴脱羧，帮助更多左旋多巴到达脑内；恩他卡朋可逆、选择性抑制 COMT，从另一条外周代谢路径影响左旋多巴暴露。这个机制只解释为什么一片有三种成分，不能推导个人强度、频率、换药或联用。", "en": "The current U.S. label explains that levodopa crosses the blood-brain barrier and is converted to dopamine in the brain; carbidopa inhibits peripheral levodopa decarboxylation, allowing more levodopa to reach the brain; and entacapone is a reversible, selective COMT inhibitor that affects another peripheral levodopa pathway. This mechanism explains why one tablet has three ingredients but cannot determine an individual's strength, frequency, switch or combination." }, "checks": [ { "zh": "三条作用路径不表示三组 mg 可以分别拆开计算，也不表示 STALEVO 与单独卡比多巴/左旋多巴、恩他卡朋片或其他帕金森药之间存在网页可算的等效关系。", "en": "Three pathways do not make the three milligram values separately calculable and do not create a web-computable equivalence between STALEVO and separate carbidopa/levodopa, entacapone or another Parkinson medicine." }, { "zh": "标签把恩他卡朋描述为 COMT 抑制剂，并说明六种强度都含 200 mg。这个恒定数字是固定复方身份的重要线索，也是不能靠多片或分片自行凑左旋多巴量的原因之一。", "en": "The label describes entacapone as a COMT inhibitor and states that every strength contains 200 mg. This constant amount is a key fixed-combination identity clue and one reason multiple tablets or tablet portions must not be self-combined to obtain more levodopa." }, { "zh": "机制不能解释某次突然嗜睡、头晕、幻觉、腹泻、尿色改变或症状波动的个人原因。最有用的下一步是记录发生时间，带准确药盒和完整药单请专业人员核对；严重或快速加重时优先使用紧急渠道。", "en": "A mechanism cannot explain the individual cause of sudden sleepiness, dizziness, hallucinations, diarrhoea, urine-colour change or symptom fluctuation. Record the timing and take the exact pack and complete medicine list for professional review; use urgent services first if severe or rapidly worsening." } ], "source": { "id": "src_b7f41b68bad71874", "label": "DailyMed（NLM）：STALEVO 当前美国公开标签（12.1 Mechanism of Action）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=53c488d8-4146-7563-8021-d90c931d1a95", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-27", "reviewedAt": "2026-08-27" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "STALEVO", "generic": "卡比多巴/左旋多巴/恩他卡朋（复方）", "dosageFormClass": "STALEVO 固定三成分薄膜衣口服片：50、75、100、125、150、200 六种名称强度；每片分别含卡比多巴/左旋多巴，并固定含恩他卡朋 200 mg；美国标签所列均为 100 片瓶装" }, "labelSource": { "id": "src_b7f41b68bad71874", "label": "DailyMed（NLM）：STALEVO 当前美国公开标签（Almatica；SPL v8，2026-03-27 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=53c488d8-4146-7563-8021-d90c931d1a95", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-27", "reviewedAt": "2026-08-27" }, "productRoutes": [ { "source": { "id": "src_b7f41b68bad71874", "label": "DailyMed（NLM）：STALEVO 当前美国公开标签（Almatica；SPL v8，2026-03-27 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=53c488d8-4146-7563-8021-d90c931d1a95", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-27", "reviewedAt": "2026-08-27" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-27", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_7b18431655bfdce2", "label": "FDA：STALEVO NDA 021485 行政记录与原始申请批准日期（2003-06-11）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/21-485_STALEVO_Admindocs.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-27", "reviewedAt": "2026-08-27" }, "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-08-27", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-27", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "STALEVO 是美国 NDA 021485 的卡比多巴/左旋多巴/恩他卡朋固定三成分口服片。六种强度名称看起来只是 50 到 200 的变化，但每片都同时含三种成分，且恩他卡朋固定为 200 mg。美国当前标签明确写明：整片使用，不可掰开、压碎或咀嚼；不要靠多片或部分片剂凑更高的左旋多巴量，否则可能造成恩他卡朋过量。网页只帮助读清药盒和说明书，不计算个人片数、间隔、换药、停药或漏服处理。", "history": "FDA 行政记录将 STALEVO 原始 NDA 021485 的批准日期列为 2003-06-11；当前 DailyMed 标签列示 Initial U.S. Approval: 2003，并于 2026-03-27 生效修订。包装面板本身标注 Rev. 06/2021；页面将标签修订日与包装面板版本分开显示，不把任一日期解释为当前库存、可获得性或其他市场状态。", "sourceDocuments": [ { "id": "src_b7f41b68bad71874", "label": "DailyMed（NLM）：STALEVO 当前美国公开标签（Almatica；SPL v8，2026-03-27 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=53c488d8-4146-7563-8021-d90c931d1a95", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-27", "reviewedAt": "2026-08-27" }, { "id": "src_7b18431655bfdce2", "label": "FDA：STALEVO NDA 021485 行政记录与原始申请批准日期（2003-06-11）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/21-485_STALEVO_Admindocs.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-27", "reviewedAt": "2026-08-27" } ], "applicationNumber": "NDA 021485（FDA 原始申请行政记录与当前美国标签所列）", "approvalTimeline": [ { "date": "2003-06-11", "title": { "zh": "FDA NDA 021485 原始申请批准", "en": "FDA NDA 021485 original application approval" }, "detail": { "zh": "FDA 行政记录将 STALEVO、NDA 021485、原始 NDA 与 2003-06-11 批准日期相连，最初包括 STALEVO 50、100 和 150。该美国节点不自动建立其他市场的商品名、批准、供应、参比关系或可替代性。", "en": "The FDA administrative record links STALEVO, NDA 021485, an original NDA and the approval date 11 Jun 2003, initially covering STALEVO 50, 100 and 150. This U.S. node does not automatically establish another market's trade name, approval, supply, reference status or interchangeability." }, "source": { "id": "src_7b18431655bfdce2", "label": "FDA：STALEVO NDA 021485 行政记录与原始申请批准日期（2003-06-11）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/21-485_STALEVO_Admindocs.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-27", "reviewedAt": "2026-08-27" } }, { "date": "2026-03-27", "title": { "zh": "DailyMed 当前 SPL v8 生效", "en": "Current DailyMed SPL v8 effective" }, "detail": { "zh": "当前美国公开标签列出六种 STALEVO 强度、六个 100 片瓶装 NDC、整片使用边界及三成分机制。包装面板自身标注 Rev. 06/2021；标签生效日与包装面板版本在本页分开。", "en": "The current U.S. public label lists six STALEVO strengths, six 100-tablet bottle NDCs, the whole-tablet boundary and the three-ingredient mechanism. The package panels themselves are marked Rev. 06/2021; the label effective date and package-panel version remain separate on this page." }, "source": { "id": "src_b7f41b68bad71874", "label": "DailyMed（NLM）：STALEVO 当前美国公开标签（SPL v8，2026-03-27 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=53c488d8-4146-7563-8021-d90c931d1a95", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-27", "reviewedAt": "2026-08-27" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "已链接当前 NDA 品牌标签、六种准确三成分强度与六个包装面板", "en": "Current NDA brand label, six exact three-ingredient strengths and six package panels linked" }, "detail": { "zh": "本页分别记录 STALEVO 50、75、100、125、150、200 的三种每片成分量、NDC、100 片瓶装、LCE 刻印和来源。它用于产品身份与安全阅读，不用于鉴定真伪，也不建立当前库存、购买、个人片数、间隔、转换、停用或联用。", "en": "This page separately records all three per-tablet ingredient amounts, NDC, 100-tablet bottle, LCE imprint and source for STALEVO 50, 75, 100, 125, 150 and 200. It supports product identity and safety reading; it does not authenticate a product or establish current stock, purchase, individual tablet count, interval, conversion, stopping or co-use." } }, { "market": { "zh": "中国大陆、欧盟、日本及其他市场", "en": "Mainland China, the EU, Japan and other markets" }, "status": { "zh": "待逐项建立现行市场记录", "en": "Current market record not established" }, "detail": { "zh": "不从美国 NDA、DailyMed 名称、NDC、三组 mg、LCE 刻印或包装图推定当地商品名、批准、包装、供应、可售资格、参比/原研关系或可替代性；每个市场均须以当地现行监管资料单独核对。", "en": "No local trade name, approval, packaging, supply, sale eligibility, reference/originator relationship or interchangeability is inferred from the U.S. NDA, DailyMed name, NDC, three milligram values, LCE imprint or package image; every market requires separate review against current local regulatory material." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "STALEVO 100 上的 25/100/200，是否能只看中间的 100？", "en": "Can I read only the middle 100 in STALEVO 100's 25/100/200?" }, "answer": { "zh": "不能。25/100/200 共同识别同一片中的卡比多巴、左旋多巴和恩他卡朋。名称中的“100”只是左旋多巴这一组强度；网页不会把三组数字拆成个人剂量或换算式。", "en": "No. 25/100/200 together identify carbidopa, levodopa and entacapone in the same tablet. The '100' in the name identifies only the levodopa component; the site does not split the three numbers into an individual dose or conversion formula." } }, { "question": { "zh": "STALEVO 能否掰半，或用两片较低强度凑成一片较高强度？", "en": "Can STALEVO be split, or can two lower-strength tablets be combined to make a higher strength?" }, "answer": { "zh": "不能从网页这样操作。当前美国标签写明不要掰开、压碎或咀嚼，并指出六种强度每片都含恩他卡朋 200 mg；用多片或部分片剂凑更高左旋多巴量可能造成恩他卡朋过量。请带实际药盒、处方和完整药单请药师或开方团队核对。", "en": "Do not do this from a webpage. The current U.S. label says not to split, crush or chew and states that every strength contains entacapone 200 mg; combining tablets or tablet portions to obtain more levodopa may cause entacapone overdose. Have a pharmacist or prescriber review the actual pack, prescription and complete medicine list." } }, { "question": { "zh": "已经有 SINEMET，又看到 STALEVO，能否一起吃或轮换？", "en": "If SINEMET is already on the list, can STALEVO be taken with it or alternated?" }, "answer": { "zh": "不能仅凭网页决定。两者都可能含卡比多巴/左旋多巴，但 STALEVO 另外含恩他卡朋；共同成分会带来重复成分与转换风险。应把两盒实际产品、处方时间表和完整药单交给药师或开方团队逐项核对，不要自行叠加、轮换、替代或停用。", "en": "A webpage cannot decide this. Both may contain carbidopa/levodopa, while STALEVO additionally contains entacapone; shared ingredients create duplicate-ingredient and conversion risks. Have a pharmacist or prescriber review both actual products, the prescribed schedule and complete medicine list; do not self-stack, alternate, substitute or stop." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "dosage-forms-are-part-of-medicine-identity", "how-to-read-a-drug-label" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/stalevo/", "en": "https://origindrug.com/en/drugs/stalevo/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "savaysa", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-28", "status": "published_traceable_archive" }, "names": { "brand": "SAVAYSA", "generic": "依度沙班（美国标签：依度沙班甲苯磺酸盐；日本：依度沙班甲苯磺酸盐水合物）", "aliases": [ "Savaysa", "LIXIANA", "Lixiana", "リクシアナ", "edoxaban", "edoxaban tosylate", "edoxaban tosilate", "依度沙班", "依度沙班甲苯磺酸盐", "依度沙班甲苯磺酸盐水合物", "65597-201-30", "65597-202-30", "65597-202-05", "65597-203-05", "DSC L15", "DSC L30", "DSC L60" ], "marketBrandNames": [ { "name": "LIXIANA", "market": { "zh": "欧盟", "en": "European Union" }, "evidenceStatus": "current_regulatory_record", "note": { "zh": "EMA 集中许可产品名；准确国家包装和供应须按当地现行资料核对。", "en": "EMA central-authorisation product name; exact national packs and supply require current local review." }, "source": { "id": "src_7996b926bd9d287a", "label": "EMA：LIXIANA 欧盟集中许可产品页与产品资料入口", "url": "https://www.ema.europa.eu/en/medicines/human/EPAR/lixiana", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" } }, { "name": "リクシアナ", "market": { "zh": "日本", "en": "Japan" }, "evidenceStatus": "current_regulatory_record", "note": { "zh": "PMDA 当前产品页所列日文商品名；不与美国 NDC 或欧盟包装合并。", "en": "Japanese trade name in the current PMDA product page; not merged with U.S. NDCs or EU packs." }, "source": { "id": "src_a74821c7ca0cde93", "label": "PMDA：リクシアナ錠 15 mg／30 mg／60 mg 当前公众产品页", "url": "https://www.pmda.go.jp/PmdaSearch/rdDetail/iyaku/3339002F1020_1?user=2", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" } } ], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "抗凝与血液", "sourceArchiveMarket": "美国：SAVAYSA 依度沙班薄膜衣口服片，NDA 206316，DailyMed 页面 2025-07-10 更新。欧盟：LIXIANA 集中上市许可自 2015-06-19 有效，EMA 产品资料入口提供欧盟官方语言版本。日本：PMDA 当前产品页列示リクシアナ錠 15/30/60 mg、现行说明书、患者用药指南与风险管理资料。本页分别保留三地监管身份，不据此推定中国大陆或其他市场的批准、商品名、包装、供应、可售资格或可替代性。", "dosageFormClass": "依度沙班薄膜衣口服片：美国 SAVAYSA 15 mg、30 mg、60 mg；本档案分别建立 15 mg/30 片瓶、30 mg/30 片瓶、30 mg/50 片医院用泡罩纸盒及 60 mg/50 片医院用泡罩纸盒身份。欧盟 LIXIANA 与日本リクシアナ的规格和包装须按各自文件另行核对，不与美国 NDC 合并。", "dosageFormClassCode": "oral_solid", "route": "口服（高风险跨市场抗凝准确产品身份字段）", "routeCode": "oral", "historicalApprovalEntry": "2015-01-08（FDA NDA 206316 批准）；2015-06-19（欧盟 LIXIANA 上市许可）", "archiveSponsorText": "Daiichi Sankyo Inc.（美国）；Daiichi Sankyo Europe GmbH（欧盟）；第一三共株式会社（日本）" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [ "apixaban", "ELIQUIS", "阿哌沙班", "rivaroxaban", "XARELTO", "利伐沙班", "dabigatran", "PRADAXA", "达比加群酯", "warfarin", "COUMADIN", "华法林", "heparin", "肝素", "another-market edoxaban pack", "其他市场依度沙班包装" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-savaysa-edoxaban-15mg-30-bottle-ndc-65597-201-30", "marketCode": "US", "labelVersion": { "zh": "DailyMed 美国公开标签（页面 2025-07-10 更新；处方信息 2023-10 修订）", "en": "U.S. DailyMed public label (page updated 10 Jul 2025; prescribing information revised Oct 2023)" }, "dosageForm": { "zh": "SAVAYSA 依度沙班薄膜衣口服片", "en": "SAVAYSA edoxaban film-coated oral tablet" }, "route": { "zh": "口服（高风险抗凝准确产品身份字段）", "en": "oral (higher-risk anticoagulant exact-product identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 65597-201-30", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片依度沙班 15 mg；30 片瓶装", "en": "Edoxaban 15 mg per tablet; 30-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=savaysa-07.jpg&setid=e77d3400-56ad-11e3-949a-0800200c9a66", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "依度沙班（以依度沙班甲苯磺酸盐计量）", "en": "edoxaban (supplied as edoxaban tosylate)" }, "value": 15, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、频率、漏服、停用或换药指令", "en": "labelled amount per tablet; not an individual's tablet count, frequency, missed-use, stopping or switching instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "片/包装", "en": "tablets per pack" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-28", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 30, "unit": { "zh": "片/包装", "en": "tablets per pack" } }, "physicalClues": { "color": { "zh": "橙色", "en": "orange" }, "shape": { "zh": "圆形、无刻痕薄膜衣片", "en": "round, unscored film-coated tablet" }, "imprint": "DSC L15", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_a4dc149f928ad43b", "label": "DailyMed（NLM）：SAVAYSA 依度沙班 15 mg，NDC 65597-201-30，30 片瓶装美国标签面板", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=e77d3400-56ad-11e3-949a-0800200c9a66", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-savaysa-edoxaban-30mg-30-bottle-ndc-65597-202-30", "marketCode": "US", "labelVersion": { "zh": "DailyMed 美国公开标签（页面 2025-07-10 更新；处方信息 2023-10 修订）", "en": "U.S. DailyMed public label (page updated 10 Jul 2025; prescribing information revised Oct 2023)" }, "dosageForm": { "zh": "SAVAYSA 依度沙班薄膜衣口服片", "en": "SAVAYSA edoxaban film-coated oral tablet" }, "route": { "zh": "口服（高风险抗凝准确产品身份字段）", "en": "oral (higher-risk anticoagulant exact-product identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 65597-202-30", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片依度沙班 30 mg；30 片瓶装", "en": "Edoxaban 30 mg per tablet; 30-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=savaysa-08.jpg&setid=e77d3400-56ad-11e3-949a-0800200c9a66", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "依度沙班（以依度沙班甲苯磺酸盐计量）", "en": "edoxaban (supplied as edoxaban tosylate)" }, "value": 30, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、频率、漏服、停用或换药指令", "en": "labelled amount per tablet; not an individual's tablet count, frequency, missed-use, stopping or switching instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "片/包装", "en": "tablets per pack" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-28", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 30, "unit": { "zh": "片/包装", "en": "tablets per pack" } }, "physicalClues": { "color": { "zh": "粉红色", "en": "pink" }, "shape": { "zh": "圆形、无刻痕薄膜衣片", "en": "round, unscored film-coated tablet" }, "imprint": "DSC L30", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_a4dc149f928ad43b", "label": "DailyMed（NLM）：SAVAYSA 依度沙班 30 mg，NDC 65597-202-30，30 片瓶装美国标签面板", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=e77d3400-56ad-11e3-949a-0800200c9a66", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-savaysa-edoxaban-30mg-50-hospital-blister-carton-ndc-65597-202-05", "marketCode": "US", "labelVersion": { "zh": "DailyMed 美国公开标签（页面 2025-07-10 更新；处方信息 2023-10 修订）", "en": "U.S. DailyMed public label (page updated 10 Jul 2025; prescribing information revised Oct 2023)" }, "dosageForm": { "zh": "SAVAYSA 依度沙班薄膜衣口服片", "en": "SAVAYSA edoxaban film-coated oral tablet" }, "route": { "zh": "口服（高风险抗凝准确产品身份字段）", "en": "oral (higher-risk anticoagulant exact-product identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 65597-202-05", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片依度沙班 30 mg；5 板 × 10 片、共 50 片医院用泡罩板纸盒", "en": "Edoxaban 30 mg per tablet; five 10-tablet blister cards, 50 tablets total, hospital-use carton" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=savaysa-09.jpg&setid=e77d3400-56ad-11e3-949a-0800200c9a66", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "依度沙班（以依度沙班甲苯磺酸盐计量）", "en": "edoxaban (supplied as edoxaban tosylate)" }, "value": 30, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、频率、漏服、停用或换药指令", "en": "labelled amount per tablet; not an individual's tablet count, frequency, missed-use, stopping or switching instruction" } } ], "concentration": null, "container": { "typeCode": "blister_carton", "typeLabel": { "zh": "医院用泡罩板纸盒", "en": "hospital-use blister-card carton" }, "fill": null, "countPerPackage": 50, "countUnit": { "zh": "片/包装", "en": "tablets per pack" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-28", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 50, "unit": { "zh": "片/包装", "en": "tablets per pack" } }, "physicalClues": { "color": { "zh": "粉红色", "en": "pink" }, "shape": { "zh": "圆形、无刻痕薄膜衣片", "en": "round, unscored film-coated tablet" }, "imprint": "DSC L30", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_a4dc149f928ad43b", "label": "DailyMed（NLM）：SAVAYSA 依度沙班 30 mg，NDC 65597-202-05，5 板 × 10 片、共 50 片医院用泡罩板纸盒美国标签面板", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=e77d3400-56ad-11e3-949a-0800200c9a66", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-savaysa-edoxaban-60mg-50-hospital-blister-carton-ndc-65597-203-05", "marketCode": "US", "labelVersion": { "zh": "DailyMed 美国公开标签（页面 2025-07-10 更新；处方信息 2023-10 修订）", "en": "U.S. DailyMed public label (page updated 10 Jul 2025; prescribing information revised Oct 2023)" }, "dosageForm": { "zh": "SAVAYSA 依度沙班薄膜衣口服片", "en": "SAVAYSA edoxaban film-coated oral tablet" }, "route": { "zh": "口服（高风险抗凝准确产品身份字段）", "en": "oral (higher-risk anticoagulant exact-product identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 65597-203-05", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片依度沙班 60 mg；5 板 × 10 片、共 50 片医院用泡罩板纸盒", "en": "Edoxaban 60 mg per tablet; five 10-tablet blister cards, 50 tablets total, hospital-use carton" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=savaysa-10.jpg&setid=e77d3400-56ad-11e3-949a-0800200c9a66", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "依度沙班（以依度沙班甲苯磺酸盐计量）", "en": "edoxaban (supplied as edoxaban tosylate)" }, "value": 60, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、频率、漏服、停用或换药指令", "en": "labelled amount per tablet; not an individual's tablet count, frequency, missed-use, stopping or switching instruction" } } ], "concentration": null, "container": { "typeCode": "blister_carton", "typeLabel": { "zh": "医院用泡罩板纸盒", "en": "hospital-use blister-card carton" }, "fill": null, "countPerPackage": 50, "countUnit": { "zh": "片/包装", "en": "tablets per pack" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-28", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 50, "unit": { "zh": "片/包装", "en": "tablets per pack" } }, "physicalClues": { "color": { "zh": "黄色", "en": "yellow" }, "shape": { "zh": "圆形、无刻痕薄膜衣片", "en": "round, unscored film-coated tablet" }, "imprint": "DSC L60", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_a4dc149f928ad43b", "label": "DailyMed（NLM）：SAVAYSA 依度沙班 60 mg，NDC 65597-203-05，5 板 × 10 片、共 50 片医院用泡罩板纸盒美国标签面板", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=e77d3400-56ad-11e3-949a-0800200c9a66", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-savaysa-edoxaban-15mg-30-bottle-ndc-65597-201-30", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=savaysa-07.jpg&setid=e77d3400-56ad-11e3-949a-0800200c9a66", "alt": "SAVAYSA 依度沙班 15 mg、NDC 65597-201-30、30 片瓶装的美国 DailyMed 标签展示面", "archiveMarket": "美国", "labelVersion": "DailyMed 页面 2025-07-10 更新；处方信息 2023-10 修订", "presentation": "SAVAYSA 依度沙班 15 mg、NDC 65597-201-30、30 片瓶装标签展示面。片剂为橙色圆形无刻痕薄膜衣片，刻印 DSC L15。", "notice": "此图只对应所引美国 DailyMed 标签中的 SAVAYSA 15 mg、NDC 65597-201-30、30 片瓶装。它不代表 30 mg、60 mg、LIXIANA／リクシアナ、其他依度沙班产品、其他市场包装或当前可得性；不用于鉴定真伪，也不生成个人片数、补服、停药、换药或手术前后方案。", "source": { "id": "src_a4dc149f928ad43b", "label": "DailyMed（NLM）：SAVAYSA 依度沙班 15 mg、NDC 65597-201-30、30 片瓶装美国标签面板", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=e77d3400-56ad-11e3-949a-0800200c9a66", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "SAVAYSA／LIXIANA 说明书放大阅读：先认清抗凝药，再核对出血、停药与操作风险", "en": "SAVAYSA/LIXIANA label reading: identify the anticoagulant, then review bleeding, interruption and procedure risks" }, "summary": { "zh": "依度沙班是高风险口服抗凝药。美国标签有黑框警告：部分非瓣膜性房颤患者的肾功能范围会影响药物是否适用；过早停用可能增加缺血事件；接受脊柱/硬膜外穿刺或麻醉时可能发生脊髓或硬膜外血肿。网页不计算肌酐清除率、不选择强度，也不安排停药、桥接、补服或转换。", "en": "Edoxaban is a higher-risk oral anticoagulant. The U.S. label carries boxed warnings about reduced efficacy in a renal-function subgroup with nonvalvular atrial fibrillation, ischaemic risk after premature discontinuation, and spinal or epidural haematoma around neuraxial procedures. The site does not calculate creatinine clearance, select a strength, or plan interruption, bridging, missed use or switching." }, "checks": [ { "zh": "先同时核对商品名、依度沙班、目标市场、15/30/60 mg 每片强度、包装、NDC 或当地批准资料。相同成分名不表示美国 SAVAYSA、欧盟 LIXIANA、日本リクシアナ及其他市场包装可以互换。", "en": "Check the brand, edoxaban, target market, 15/30/60 mg strength per tablet, pack, NDC or local authorisation record together. A shared ingredient name does not make U.S. SAVAYSA, EU LIXIANA, Japanese リクシアナ or another market pack interchangeable." }, { "zh": "把肾功能、体重、年龄、肝脏情况、近期手术/拔牙/腰穿计划、跌倒，以及包含全部处方药、非处方药和补充剂的完整药单一起交给开方团队或药师核对。其他抗凝药、抗血小板药、溶栓药、部分止痛药和部分抗抑郁药可能增加出血风险；不要自行同服、轮换或错开。", "en": "Have the prescriber or pharmacist review renal function, body weight, age, liver status, planned surgery/dental work/lumbar puncture, falls, and a complete medicine list containing every prescription, non-prescription product and supplement. Other anticoagulants, antiplatelets, thrombolytics, some pain medicines and some antidepressants may increase bleeding risk; do not self-combine, alternate or space them." }, { "zh": "不要因一次漏服、出血担忧、准备检查或看见另一种抗凝药就自行停用、加倍、补服或换药。美国、欧盟和日本说明书的具体规则可能不同，必须回到本人处方、目标市场现行说明书和负责治疗团队。", "en": "Do not self-stop, double, make up or switch because of one missed use, bleeding concern, a planned test or another anticoagulant. Exact rules can differ across U.S., EU and Japanese labels; return to the individual's prescription, current target-market label and treating team." }, { "zh": "持续或严重出血、黑便、呕血、咳血、血尿、突发剧烈头痛、一侧无力、言语含糊、明显头晕/昏厥、跌倒撞头或意识改变需要立即使用当地急救渠道，并带上全部药盒和用药清单；不要等待网页回复。", "en": "Persistent or severe bleeding, black stools, vomiting or coughing blood, blood in urine, sudden severe headache, one-sided weakness, slurred speech, marked dizziness/fainting, a fall with head impact or altered consciousness requires local emergency help immediately. Bring every medicine pack and the medicine list; do not wait for a web response." } ], "source": { "id": "src_a4dc149f928ad43b", "label": "DailyMed（NLM）：SAVAYSA 当前美国公开标签（黑框警告、出血、相互作用与患者指导）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=e77d3400-56ad-11e3-949a-0800200c9a66", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "依度沙班怎样起作用：直接抑制凝血因子 Xa，减少凝血酶生成", "en": "How edoxaban works: direct factor Xa inhibition reduces thrombin generation" }, "summary": { "zh": "美国标签说明，依度沙班是选择性凝血因子 Xa 抑制剂，不需要抗凝血酶 III 参与；抑制 Xa 会减少凝血酶生成和血栓形成。这个机制解释抗凝与出血为何要同时关注，但不能推导任何人的强度、频率、疗程、停用或换药。", "en": "The U.S. label describes edoxaban as a selective factor Xa inhibitor that does not require antithrombin III. Factor Xa inhibition reduces thrombin generation and thrombus formation. This explains why anticoagulation and bleeding must be considered together, but it cannot determine anyone's strength, frequency, duration, interruption or switch." }, "checks": [ { "zh": "“抑制 Xa”不表示所有口服抗凝药都一样。依度沙班、阿哌沙班、利伐沙班、达比加群酯、华法林及注射抗凝药的成分、机制、监测、适用范围和转换规则不同。", "en": "“Factor Xa inhibition” does not make all oral anticoagulants the same. Edoxaban, apixaban, rivaroxaban, dabigatran, warfarin and injectable anticoagulants differ in ingredient, mechanism, monitoring, labelled uses and transition rules." }, { "zh": "药效机制不能判断某个人的肾功能范围、体重或其他药物是否需要改变方案；这些事实必须由专业人员结合目标市场说明书和处方核对。网页不提供肌酐清除率计算器或剂量选择器。", "en": "A mechanism cannot decide whether an individual's renal-function range, body weight or other medicines require a change. A professional must review those facts against the target-market label and prescription. The site does not provide a creatinine-clearance calculator or dose selector." }, { "zh": "抗凝药减少血栓风险也会带来出血风险。最有用的行动是随身保留准确药名和强度、主动告诉手术/牙科/急诊团队、记录异常出血，并在严重症状时立即求助。", "en": "Anticoagulation reduces clotting risk and also creates bleeding risk. Useful actions are to carry the exact drug name and strength, tell surgical, dental and emergency teams, record unusual bleeding, and seek immediate help for serious symptoms." } ], "source": { "id": "src_a4dc149f928ad43b", "label": "DailyMed（NLM）：SAVAYSA 当前美国公开标签（12.1 Mechanism of Action）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=e77d3400-56ad-11e3-949a-0800200c9a66", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "SAVAYSA", "generic": "依度沙班（美国标签：依度沙班甲苯磺酸盐；日本：依度沙班甲苯磺酸盐水合物）", "dosageFormClass": "依度沙班薄膜衣口服片：美国 SAVAYSA 15 mg、30 mg、60 mg；本档案分别建立 15 mg/30 片瓶、30 mg/30 片瓶、30 mg/50 片医院用泡罩纸盒及 60 mg/50 片医院用泡罩纸盒身份。欧盟 LIXIANA 与日本リクシアナ的规格和包装须按各自文件另行核对，不与美国 NDC 合并。" }, "labelSource": { "id": "src_a4dc149f928ad43b", "label": "DailyMed（NLM）：SAVAYSA 依度沙班当前美国公开标签（Daiichi Sankyo；页面 2025-07-10 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=e77d3400-56ad-11e3-949a-0800200c9a66", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" }, "productRoutes": [ { "source": { "id": "src_a4dc149f928ad43b", "label": "DailyMed（NLM）：SAVAYSA 依度沙班当前美国公开标签（Daiichi Sankyo；页面 2025-07-10 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=e77d3400-56ad-11e3-949a-0800200c9a66", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-28", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_091d0d5a399120ee", "label": "FDA：SAVAYSA NDA 206316 批准函（2015-01-08；15/30/60 mg）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/206316Orig2s000ltr.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" }, "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-08-28", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_7996b926bd9d287a", "label": "EMA：LIXIANA 欧盟集中许可产品页（许可自 2015-06-19 有效）", "url": "https://www.ema.europa.eu/en/medicines/human/EPAR/lixiana", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" }, "status": "product_level_public_record_verified", "authority": { "zh": "EMA", "en": "EMA" }, "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "recordType": { "zh": "监管产品记录或欧盟产品资料", "en": "Regulatory product record or EU product information" }, "reviewedAt": "2026-08-28", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_7c0fe3f96c686f05", "label": "EMA：LIXIANA 欧盟产品资料（含专业资料、标签与患者说明书）", "url": "https://www.ema.europa.eu/en/documents/product-information/lixiana-epar-product-information_en.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" }, "status": "product_level_public_record_verified", "authority": { "zh": "EMA", "en": "EMA" }, "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "recordType": { "zh": "监管产品记录或欧盟产品资料", "en": "Regulatory product record or EU product information" }, "reviewedAt": "2026-08-28", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_a74821c7ca0cde93", "label": "PMDA：リクシアナ錠 15/30/60 mg 当前产品页与患者资料入口", "url": "https://www.pmda.go.jp/PmdaSearch/rdDetail/iyaku/3339002F1020_1?user=2", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" }, "status": "product_level_public_record_verified", "authority": { "zh": "PMDA", "en": "PMDA" }, "market": { "zh": "日本", "en": "Japan" }, "recordType": { "zh": "监管产品记录", "en": "Regulatory product record" }, "reviewedAt": "2026-08-28", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_9d995775b9ea1d49", "label": "PMDA：リクシアナ錠当前电子说明书入口", "url": "https://www.pmda.go.jp/PmdaSearch/bookSearch/01/14987081102751", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" }, "status": "product_level_public_record_verified", "authority": { "zh": "PMDA", "en": "PMDA" }, "market": { "zh": "日本", "en": "Japan" }, "recordType": { "zh": "监管产品记录", "en": "Regulatory product record" }, "reviewedAt": "2026-08-28", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-28", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "SAVAYSA／LIXIANA 是依度沙班口服抗凝药的不同市场商品名。它抑制凝血因子 Xa，适应症、限制和具体使用规则必须对应所在市场、疾病情境、肾功能、体重、完整药单与现行说明书。最重要的普通人提示不是自行计算片数，而是：不要凭网页停药、补服、换成另一种抗凝药，做手术、拔牙、腰穿或硬膜外操作前主动说明正在使用抗凝药；出现持续或严重出血、黑便、呕血、咳血、突发剧烈头痛、明显无力或意识改变时立即使用当地急救渠道。", "history": "FDA 于 2015-01-08 批准 SAVAYSA NDA 206316 的 15、30、60 mg 口服片；当前 DailyMed 页面显示 2025-07-10 更新，处方信息正文修订于 2023-10。EMA 记录 LIXIANA 欧盟许可自 2015-06-19 有效，产品资料在 2025-08-27 更新。日本 PMDA 当前公众页列示リクシアナ錠 15/30/60 mg，并提供患者用药指南和出血倾向等安全资料入口。", "sourceDocuments": [ { "id": "src_a4dc149f928ad43b", "label": "DailyMed（NLM）：SAVAYSA 依度沙班当前美国公开标签（Daiichi Sankyo；页面 2025-07-10 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=e77d3400-56ad-11e3-949a-0800200c9a66", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" }, { "id": "src_091d0d5a399120ee", "label": "FDA：SAVAYSA NDA 206316 批准函（2015-01-08；15/30/60 mg）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/206316Orig2s000ltr.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" }, { "id": "src_7996b926bd9d287a", "label": "EMA：LIXIANA 欧盟集中许可产品页（许可自 2015-06-19 有效）", "url": "https://www.ema.europa.eu/en/medicines/human/EPAR/lixiana", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" }, { "id": "src_7c0fe3f96c686f05", "label": "EMA：LIXIANA 欧盟产品资料（含专业资料、标签与患者说明书）", "url": "https://www.ema.europa.eu/en/documents/product-information/lixiana-epar-product-information_en.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" }, { "id": "src_a74821c7ca0cde93", "label": "PMDA：リクシアナ錠 15/30/60 mg 当前产品页与患者资料入口", "url": "https://www.pmda.go.jp/PmdaSearch/rdDetail/iyaku/3339002F1020_1?user=2", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" }, { "id": "src_9d995775b9ea1d49", "label": "PMDA：リクシアナ錠当前电子说明书入口", "url": "https://www.pmda.go.jp/PmdaSearch/bookSearch/01/14987081102751", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" } ], "applicationNumber": "FDA NDA 206316（美国 SAVAYSA）；EMA EU/1/15/993（欧盟 LIXIANA）；日本产品身份见 PMDA 当前リクシアナ页面", "approvalTimeline": [ { "date": "2015-01-08", "title": { "zh": "FDA 批准 SAVAYSA NDA 206316", "en": "FDA approved SAVAYSA NDA 206316" }, "detail": { "zh": "FDA 批准函与 Drug Trials Snapshot 将 SAVAYSA、依度沙班、15/30/60 mg 口服片、NDA 206316 和 2015-01-08 批准日期相连。该节点只建立美国产品史，不自动建立欧盟、日本、中国大陆或其他市场的包装、供应或互换关系。", "en": "The FDA approval letter and Drug Trials Snapshot link SAVAYSA, edoxaban, 15/30/60 mg oral tablets, NDA 206316 and the approval date 8 Jan 2015. This establishes U.S. product history only; it does not automatically establish packaging, supply or interchangeability in the EU, Japan, Mainland China or another market." }, "source": { "id": "src_091d0d5a399120ee", "label": "FDA：SAVAYSA NDA 206316 批准函（2015-01-08；15/30/60 mg）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/206316Orig2s000ltr.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" } }, { "date": "2015-06-19", "title": { "zh": "LIXIANA 获欧盟集中上市许可", "en": "LIXIANA received central EU marketing authorisation" }, "detail": { "zh": "EMA 产品页将 LIXIANA 的欧盟集中上市许可日期列为 2015-06-19，并提供欧盟官方语言的产品资料、标签与患者说明书入口。该节点不把欧盟包装与美国 NDC 或日本产品合并。", "en": "EMA lists 19 Jun 2015 as the date of LIXIANA's central EU marketing authorisation and provides product information, labelling and patient leaflets in official EU languages. This node does not merge EU packs with U.S. NDCs or Japanese products." }, "source": { "id": "src_7996b926bd9d287a", "label": "EMA：LIXIANA 欧盟集中许可产品页（许可自 2015-06-19 有效）", "url": "https://www.ema.europa.eu/en/medicines/human/EPAR/lixiana", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" } }, { "date": "2026-08-28", "title": { "zh": "美国、欧盟与日本现行公开入口联合复核", "en": "Current U.S., EU and Japanese public routes reviewed together" }, "detail": { "zh": "本轮分别复核 DailyMed 当前美国标签、EMA LIXIANA 产品页/产品资料，以及 PMDA リクシアナ公众页/电子说明书入口。页面保留各市场边界，不把一次复核日期写成库存、购买或个人用药结论。", "en": "This review separately checked the current U.S. DailyMed label, EMA LIXIANA page/product information, and PMDA LIXIANA public page/electronic-label route. Market boundaries remain explicit; the review date is not a stock, purchase or individual-use conclusion." }, "source": { "id": "src_a74821c7ca0cde93", "label": "PMDA：リクシアナ錠 15/30/60 mg 当前产品页与患者资料入口", "url": "https://www.pmda.go.jp/PmdaSearch/rdDetail/iyaku/3339002F1020_1?user=2", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "已链接当前标签、NDA 历史与四个准确包装身份", "en": "Current label, NDA history and four exact pack identities linked" }, "detail": { "zh": "分别记录 SAVAYSA 15 mg/30 片瓶、30 mg/30 片瓶、30 mg/50 片医院泡罩纸盒及 60 mg/50 片医院泡罩纸盒的 NDC、颜色、刻印和来源；不建立库存、购买、真伪、个人片数、漏服、停用、转换或操作前后方案。", "en": "Separately records NDC, colour, imprint and source for SAVAYSA 15 mg/30-tablet bottle, 30 mg/30-tablet bottle, 30 mg/50-tablet hospital blister carton and 60 mg/50-tablet hospital blister carton. It does not establish stock, purchase, authenticity, individual tablet count, missed-use, interruption, transition or peri-procedure plans." } }, { "market": { "zh": "欧盟", "en": "European Union" }, "status": { "zh": "已链接 EMA LIXIANA 集中许可与多语言产品资料", "en": "EMA LIXIANA central authorisation and multilingual product information linked" }, "detail": { "zh": "EMA 提供产品专业资料、标签与患者说明书，并说明资料可在欧盟官方语言中获取；准确国家包装和供应仍须按当地资料核对，不与美国 SAVAYSA NDC 合并。", "en": "EMA provides professional information, labelling and the patient leaflet in official EU languages. Exact national packs and supply still require local review and are not merged with U.S. SAVAYSA NDCs." } }, { "market": { "zh": "日本", "en": "Japan" }, "status": { "zh": "已链接 PMDA リクシアナ 15/30/60 mg 产品、安全与患者资料入口", "en": "PMDA LIXIANA 15/30/60 mg product, safety and patient-information routes linked" }, "detail": { "zh": "PMDA 当前公众页列示リクシアナ錠 15/30/60 mg、依度沙班甲苯磺酸盐水合物，并提供患者指南与出血倾向等安全资料入口；本页不把日本产品号、包装或使用规则与美国/欧盟合并。", "en": "The current PMDA public page lists LIXIANA 15/30/60 mg tablets and edoxaban tosilate hydrate and provides patient-guide and bleeding-risk information routes. Japanese product numbers, packs and use rules are not merged with U.S./EU records." } }, { "market": { "zh": "中国大陆及其他市场", "en": "Mainland China and other markets" }, "status": { "zh": "待逐项建立现行监管产品记录", "en": "Current regulatory product record not established" }, "detail": { "zh": "不从 SAVAYSA、LIXIANA、リクシアナ、共同成分或三个市场资料推定当地批准、商品名、包装、供应、原研/参比关系或互换；须按当地现行监管资料逐产品核对。", "en": "No local approval, trade name, packaging, supply, originator/reference relationship or interchangeability is inferred from SAVAYSA, LIXIANA, リクシアナ, a shared ingredient or the three reviewed market records; each product requires current local regulatory review." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "SAVAYSA、LIXIANA 和リクシアナ是同一种药吗，能直接替换吗？", "en": "Are SAVAYSA, LIXIANA and リクシアナ the same medicine and directly interchangeable?" }, "answer": { "zh": "它们都可指向依度沙班产品，但属于不同监管市场。共同成分不能证明强度、辅料、包装、批准用途、限制、供应或处方规则完全相同，更不能建立自行替换。请用实际药盒、目标市场说明书和处方由药师或开方团队核对。", "en": "They can all identify edoxaban products, but they belong to different regulatory markets. A shared ingredient does not prove identical strength, excipients, packaging, authorised uses, restrictions, supply or prescription rules and cannot establish self-substitution. Have a pharmacist or prescriber review the actual pack, target-market label and prescription." } }, { "question": { "zh": "15、30、60 mg 能否自己换算片数，或漏服后补两片？", "en": "Can 15, 30 and 60 mg be converted into a tablet count, or can two tablets be taken after a missed use?" }, "answer": { "zh": "不能。mg 是准确片剂的每片标示量，个人强度和规则还取决于适应症、肾功能、体重、合并用药及目标市场说明书。网页不提供片数换算、漏服补量、停用或转换指令；请按本人处方联系开方团队或药师。", "en": "No. mg is the labelled amount per exact tablet; individual strength and rules also depend on the indication, renal function, body weight, co-medications and target-market label. The site provides no tablet-count conversion, missed-use make-up, interruption or transition instruction; follow the individual's prescription and contact the prescriber or pharmacist." } }, { "question": { "zh": "做手术、拔牙或腰穿前能否自己停药？", "en": "Can it be self-stopped before surgery, dental work or lumbar puncture?" }, "answer": { "zh": "不能由网页决定。抗凝中断与操作时间会同时涉及出血和血栓风险。尽早把准确药名、强度、最近使用时间、肾功能与完整药单告知负责操作和开方的团队，由他们按现行说明书和临床情况安排；不要自行停用或用另一种抗凝药替代。", "en": "A webpage cannot decide this. Anticoagulant interruption and procedure timing involve both bleeding and clotting risks. Tell the procedural and prescribing teams the exact drug, strength, last use, renal function and complete medicine list early, so they can plan from the current label and clinical context; do not self-stop or substitute another anticoagulant." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "dosage-forms-are-part-of-medicine-identity", "how-to-read-a-drug-label" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/savaysa/", "en": "https://origindrug.com/en/drugs/savaysa/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "medrol", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-28", "status": "published_traceable_archive" }, "names": { "brand": "MEDROL", "generic": "甲泼尼龙", "aliases": [ "Medrol", "美卓乐", "methylprednisolone", "甲基泼尼松龙", "methylprednisolone tablets", "甲泼尼龙", "甲泼尼龙片", "0009-0020-01", "0009-0056-02", "0009-0056-04", "0009-0022-01", "0009-0073-01", "0009-0176-01", "MEDROL 2", "MEDROL 4", "MEDROL 8", "MEDROL 16", "MEDROL 32", "Dosepak" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": { "value": "美卓乐®", "status": "discovery_cue_requires_target_market_verification", "source": { "id": "src_5f489f63ec02d427", "label": "天津市医疗保障局：药品支付范围公开文件中的美卓乐／甲泼尼龙片 4 mg 记录", "url": "https://ylbz.tj.gov.cn/xwzx/tzgg/202301/W020230105617775760187.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "reimbursement_lookup", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-12", "reviewedAt": "2026-09-12" } } }, "identity": { "therapeuticArea": "免疫", "sourceArchiveMarket": "美国 MEDROL 甲泼尼龙口服片当前公开标签（DailyMed：2025-11 修订；NDA 011153）。本档案精确建立 2、4、8、16、32 mg 瓶装及 4 mg／21 片 Dosepak 纸盒身份；不从美国标签推定中国大陆或其他市场的商品名、包装、批准、供应、原研/仿制关系或可替代性。", "dosageFormClass": "MEDROL 甲泼尼龙口服片：2、4、8、16、32 mg；另列 4 mg、21 片单位剂量 Dosepak 纸盒（当前美国公开标签所列）", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "1957（DailyMed 当前美国公开标签所列 Initial U.S. Approval）", "archiveSponsorText": "Pharmacia & Upjohn Company LLC（Pfizer 子公司；当前美国公开标签所列）" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [ "DEPO-MEDROL", "SOLU-MEDROL", "methylprednisolone acetate injection", "methylprednisolone sodium succinate injection", "甲泼尼龙注射剂" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-medrol-methylprednisolone-2mg-100-tablet-bottle-ndc-0009002001", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（2025-11 修订）", "en": "Current U.S. DailyMed public label (revised Nov 2025)" }, "dosageForm": { "zh": "MEDROL 甲泼尼龙口服片", "en": "MEDROL methylprednisolone oral tablet" }, "route": { "zh": "口服（产品身份字段）", "en": "oral (product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 0009-0020-01", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片甲泼尼龙 2 mg；100 片瓶装", "en": "Methylprednisolone 2 mg per tablet; 100-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=medrol-09.jpg&setid=39d5270b-d957-4821-93d6-501b7b9f02d4&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "甲泼尼龙", "en": "methylprednisolone" }, "value": 2, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、频率、递减或停药指令", "en": "labelled amount per tablet; not an individual's tablet count, frequency, taper or stopping instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "片/包装", "en": "tablets per pack" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-28", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "片/包装", "en": "tablets per pack" } }, "physicalClues": { "color": { "zh": "白色", "en": "white" }, "shape": { "zh": "椭圆形、有刻痕片；刻痕只作外观核对，不是自行掰片许可", "en": "elliptical scored tablet; the score is an appearance clue, not permission to self-split" }, "imprint": "MEDROL 2", "scoreStatus": "scored_status_not_a_split_instruction", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_0f04138903f051f5", "label": "DailyMed（NLM）：MEDROL 甲泼尼龙 2 mg、100 片瓶装美国公开标签面板", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=39d5270b-d957-4821-93d6-501b7b9f02d4", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-medrol-methylprednisolone-4mg-100-tablet-bottle-ndc-0009005602", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（2025-11 修订）", "en": "Current U.S. DailyMed public label (revised Nov 2025)" }, "dosageForm": { "zh": "MEDROL 甲泼尼龙口服片", "en": "MEDROL methylprednisolone oral tablet" }, "route": { "zh": "口服（产品身份字段）", "en": "oral (product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 0009-0056-02", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片甲泼尼龙 4 mg；100 片瓶装", "en": "Methylprednisolone 4 mg per tablet; 100-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=medrol-03.jpg&setid=39d5270b-d957-4821-93d6-501b7b9f02d4&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "甲泼尼龙", "en": "methylprednisolone" }, "value": 4, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、频率、递减或停药指令", "en": "labelled amount per tablet; not an individual's tablet count, frequency, taper or stopping instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "片/包装", "en": "tablets per pack" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-28", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "片/包装", "en": "tablets per pack" } }, "physicalClues": { "color": { "zh": "白色", "en": "white" }, "shape": { "zh": "椭圆形、有刻痕片；刻痕只作外观核对，不是自行掰片许可", "en": "elliptical scored tablet; the score is an appearance clue, not permission to self-split" }, "imprint": "MEDROL 4", "scoreStatus": "scored_status_not_a_split_instruction", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_0f04138903f051f5", "label": "DailyMed（NLM）：MEDROL 甲泼尼龙 4 mg、100 片瓶装美国公开标签面板", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=39d5270b-d957-4821-93d6-501b7b9f02d4", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-medrol-methylprednisolone-4mg-21-tablet-dosepak-ndc-0009005604", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（2025-11 修订）", "en": "Current U.S. DailyMed public label (revised Nov 2025)" }, "dosageForm": { "zh": "MEDROL Dosepak 甲泼尼龙 4 mg 口服片", "en": "MEDROL Dosepak methylprednisolone 4 mg oral tablet" }, "route": { "zh": "口服（产品身份字段）", "en": "oral (product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 0009-0056-04", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片甲泼尼龙 4 mg；一板 21 片的单位剂量纸盒", "en": "Methylprednisolone 4 mg per tablet; one 21-tablet unit-of-use blister carton" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=medrol-05.jpg&setid=39d5270b-d957-4821-93d6-501b7b9f02d4&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "甲泼尼龙", "en": "methylprednisolone" }, "value": 4, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、频率、递减或停药指令", "en": "labelled amount per tablet; not an individual's tablet count, frequency, taper or stopping instruction" } } ], "concentration": null, "container": { "typeCode": "blister_carton", "typeLabel": { "zh": "单位剂量泡罩纸盒", "en": "unit-of-use blister carton" }, "fill": null, "countPerPackage": 21, "countUnit": { "zh": "片/包装", "en": "tablets per pack" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-28", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 21, "unit": { "zh": "片/包装", "en": "tablets per pack" } }, "physicalClues": { "color": { "zh": "白色", "en": "white" }, "shape": { "zh": "椭圆形、有刻痕片；刻痕只作外观核对，不是自行掰片许可", "en": "elliptical scored tablet; the score is an appearance clue, not permission to self-split" }, "imprint": "MEDROL 4", "scoreStatus": "scored_status_not_a_split_instruction", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_0f04138903f051f5", "label": "DailyMed（NLM）：MEDROL 甲泼尼龙 4 mg、21 片 Dosepak 纸盒美国公开标签面板", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=39d5270b-d957-4821-93d6-501b7b9f02d4", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-medrol-methylprednisolone-8mg-25-tablet-bottle-ndc-0009002201", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（2025-11 修订）", "en": "Current U.S. DailyMed public label (revised Nov 2025)" }, "dosageForm": { "zh": "MEDROL 甲泼尼龙口服片", "en": "MEDROL methylprednisolone oral tablet" }, "route": { "zh": "口服（产品身份字段）", "en": "oral (product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 0009-0022-01", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片甲泼尼龙 8 mg；25 片瓶装", "en": "Methylprednisolone 8 mg per tablet; 25-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=medrol-06.jpg&setid=39d5270b-d957-4821-93d6-501b7b9f02d4&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "甲泼尼龙", "en": "methylprednisolone" }, "value": 8, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、频率、递减或停药指令", "en": "labelled amount per tablet; not an individual's tablet count, frequency, taper or stopping instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 25, "countUnit": { "zh": "片/包装", "en": "tablets per pack" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-28", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 25, "unit": { "zh": "片/包装", "en": "tablets per pack" } }, "physicalClues": { "color": { "zh": "白色", "en": "white" }, "shape": { "zh": "椭圆形、有刻痕片；刻痕只作外观核对，不是自行掰片许可", "en": "elliptical scored tablet; the score is an appearance clue, not permission to self-split" }, "imprint": "MEDROL 8", "scoreStatus": "scored_status_not_a_split_instruction", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_0f04138903f051f5", "label": "DailyMed（NLM）：MEDROL 甲泼尼龙 8 mg、25 片瓶装美国公开标签面板", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=39d5270b-d957-4821-93d6-501b7b9f02d4", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-medrol-methylprednisolone-16mg-50-tablet-bottle-ndc-0009007301", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（2025-11 修订）", "en": "Current U.S. DailyMed public label (revised Nov 2025)" }, "dosageForm": { "zh": "MEDROL 甲泼尼龙口服片", "en": "MEDROL methylprednisolone oral tablet" }, "route": { "zh": "口服（产品身份字段）", "en": "oral (product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 0009-0073-01", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片甲泼尼龙 16 mg；50 片瓶装", "en": "Methylprednisolone 16 mg per tablet; 50-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=medrol-07.jpg&setid=39d5270b-d957-4821-93d6-501b7b9f02d4&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "甲泼尼龙", "en": "methylprednisolone" }, "value": 16, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、频率、递减或停药指令", "en": "labelled amount per tablet; not an individual's tablet count, frequency, taper or stopping instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 50, "countUnit": { "zh": "片/包装", "en": "tablets per pack" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-28", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 50, "unit": { "zh": "片/包装", "en": "tablets per pack" } }, "physicalClues": { "color": { "zh": "白色", "en": "white" }, "shape": { "zh": "椭圆形、有刻痕片；刻痕只作外观核对，不是自行掰片许可", "en": "elliptical scored tablet; the score is an appearance clue, not permission to self-split" }, "imprint": "MEDROL 16", "scoreStatus": "scored_status_not_a_split_instruction", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_0f04138903f051f5", "label": "DailyMed（NLM）：MEDROL 甲泼尼龙 16 mg、50 片瓶装美国公开标签面板", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=39d5270b-d957-4821-93d6-501b7b9f02d4", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-medrol-methylprednisolone-32mg-25-tablet-bottle-ndc-0009017601", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（2025-11 修订）", "en": "Current U.S. DailyMed public label (revised Nov 2025)" }, "dosageForm": { "zh": "MEDROL 甲泼尼龙口服片", "en": "MEDROL methylprednisolone oral tablet" }, "route": { "zh": "口服（产品身份字段）", "en": "oral (product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 0009-0176-01", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片甲泼尼龙 32 mg；25 片瓶装", "en": "Methylprednisolone 32 mg per tablet; 25-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=medrol-08.jpg&setid=39d5270b-d957-4821-93d6-501b7b9f02d4&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "甲泼尼龙", "en": "methylprednisolone" }, "value": 32, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、频率、递减或停药指令", "en": "labelled amount per tablet; not an individual's tablet count, frequency, taper or stopping instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 25, "countUnit": { "zh": "片/包装", "en": "tablets per pack" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-28", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 25, "unit": { "zh": "片/包装", "en": "tablets per pack" } }, "physicalClues": { "color": { "zh": "白色", "en": "white" }, "shape": { "zh": "椭圆形、有刻痕片；刻痕只作外观核对，不是自行掰片许可", "en": "elliptical scored tablet; the score is an appearance clue, not permission to self-split" }, "imprint": "MEDROL 32", "scoreStatus": "scored_status_not_a_split_instruction", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_0f04138903f051f5", "label": "DailyMed（NLM）：MEDROL 甲泼尼龙 32 mg、25 片瓶装美国公开标签面板", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=39d5270b-d957-4821-93d6-501b7b9f02d4", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-medrol-methylprednisolone-4mg-100-tablet-bottle-ndc-0009005602", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=medrol-03.jpg&setid=39d5270b-d957-4821-93d6-501b7b9f02d4&type=img", "alt": "MEDROL 甲泼尼龙 4 mg、NDC 0009-0056-02、100 片瓶装的美国 DailyMed 当前标签展示面", "archiveMarket": "美国", "labelVersion": "DailyMed 当前美国公开标签（2025-11 修订）", "presentation": "MEDROL 甲泼尼龙 4 mg、NDC 0009-0056-02、100 片瓶装标签展示面。", "notice": "此图只对应当前美国 DailyMed 标签中的 MEDROL 4 mg、NDC 0009-0056-02、100 片瓶装。它不代表 2、8、16、32 mg、4 mg Dosepak、注射剂、其他包装或其他市场；不用于鉴定真伪，也不生成个人片数、递减、补服或停药方案。", "source": { "id": "src_0f04138903f051f5", "label": "DailyMed（NLM）：MEDROL 甲泼尼龙 4 mg、NDC 0009-0056-02、100 片瓶装美国公开标签面板", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=39d5270b-d957-4821-93d6-501b7b9f02d4", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "MEDROL 说明书放大阅读：毫克、片数、Dosepak 格子和停药不是一回事", "en": "MEDROL label reading: milligrams, tablet count, Dosepak rows and stopping are different questions" }, "summary": { "zh": "当前美国标签列有五种每片强度和一个 21 片 Dosepak。最重要的阅读边界是：包装身份不等于个人方案，糖皮质激素也不能因感觉好转、担心不良反应或看见另一盒规格就自行骤停、续用、递减或替换。", "en": "The current U.S. label lists five per-tablet strengths and one 21-tablet Dosepak. The key boundary is that package identity is not an individual regimen; a glucocorticoid must not be abruptly self-stopped, extended, tapered or replaced because symptoms improve, an adverse effect is feared or another strength is seen." }, "checks": [ { "zh": "2、4、8、16、32 mg 是每片甲泼尼龙的标签标示量；100、25、50 或 21 是包装数量。两类数字不能相乘、相除或按经验变成任何人的一天片数。", "en": "2, 4, 8, 16 and 32 mg are labelled amounts of methylprednisolone per tablet; 100, 25, 50 or 21 are package counts. These two kinds of numbers cannot be multiplied, divided or turned by experience into anyone's daily tablet count." }, { "zh": "4 mg Dosepak 纸盒印有分日格子，但这只属于该准确包装。不要把图上的格子抄给另一位使用者、另一种病情、另一盒甲泼尼龙、其他激素或其他市场产品；必须以本人处方和负责团队的说明为准。", "en": "The 4 mg Dosepak carton prints day rows, but they belong only to that exact pack. Do not copy the rows to another person, condition, methylprednisolone pack, corticosteroid or market product; follow the individual's prescription and treating team's instructions." }, { "zh": "标签提示感染风险、免疫抑制、疫苗、血糖、胃肠道、眼部、情绪与睡眠等多方面问题。高龄、多病或同时使用降糖药、抗凝/抗血小板药、止痛药、利尿剂、免疫抑制药及疫苗时，应带完整药单主动核对。", "en": "The label covers infection risk, immunosuppression, vaccines, glucose, gastrointestinal, eye, mood and sleep concerns. Older people, people with several conditions, or those using glucose-lowering, anticoagulant/antiplatelet, pain, diuretic or immunosuppressive medicines, or receiving vaccines, should bring the complete medicine list for active review." }, { "zh": "出现严重呼吸困难、面唇舌喉肿胀、意识改变、明显感染迹象、黑便/呕血、突发视力变化或其他严重快速加重情况时，应立即使用当地急救或紧急医疗渠道，不要等待网页回复。", "en": "Severe breathing difficulty; swelling of the face, lips, tongue or throat; altered consciousness; marked infection signs; black stools or vomiting blood; sudden vision change; or another severe rapidly worsening problem requires local emergency or urgent medical help immediately. Do not wait for a web response." } ], "source": { "id": "src_0f04138903f051f5", "label": "DailyMed（NLM）：MEDROL 甲泼尼龙当前美国公开标签（Pfizer；2025-11 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=39d5270b-d957-4821-93d6-501b7b9f02d4", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "甲泼尼龙怎样起作用：它是一种糖皮质激素，影响炎症与免疫反应", "en": "How methylprednisolone works: a glucocorticoid that affects inflammatory and immune responses" }, "summary": { "zh": "MEDROL 标签把甲泼尼龙列为糖皮质激素。糖皮质激素可产生广泛的代谢、抗炎和免疫相关作用；这能帮助理解为什么标签涉及多个器官系统，也说明不能从“消炎”两个字推导个人片数、疗程或停药方法。", "en": "The MEDROL label identifies methylprednisolone as a glucocorticoid. Glucocorticoids can produce broad metabolic, anti-inflammatory and immune-related effects. That helps explain why the label spans several organ systems and why the word “anti-inflammatory” cannot determine an individual's tablet count, duration or stopping method." }, "checks": [ { "zh": "它不是抗菌药，也不能仅凭发热、疼痛、皮疹、咳嗽或肿胀判断是否适合。抑制炎症反应可能同时影响感染表现，具体原因与处理需要临床评估。", "en": "It is not an antibacterial medicine, and fever, pain, rash, cough or swelling alone cannot establish suitability. Suppressing inflammatory responses may also affect infection presentation, so the cause and management require clinical assessment." }, { "zh": "与泼尼松、地塞米松、氢化可的松或注射型甲泼尼龙都属于激素相关产品，不表示可按毫克数自行换算、叠加或替换；成分、效价、剂型、途径与方案都需逐项核对。", "en": "Being corticosteroid-related, like prednisone, dexamethasone, hydrocortisone or injectable methylprednisolone, does not make products self-convertible, combinable or interchangeable by milligrams. Ingredient, potency, dosage form, route and regimen each require review." }, { "zh": "机制解释不了某个人应否递减、递减多快或何时停用。尤其使用时间较长、反复疗程、多病共存或出现不适时，必须联系开方团队，不要从包装格子或网络范例制定方案。", "en": "Mechanism cannot determine whether, how quickly or when an individual should taper or stop. Especially after longer or repeated use, with multiple conditions or new symptoms, contact the prescribing team rather than building a plan from package rows or an online example." } ], "source": { "id": "src_0f04138903f051f5", "label": "DailyMed（NLM）：MEDROL 甲泼尼龙当前美国公开标签（Clinical Pharmacology 与警示阅读入口）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=39d5270b-d957-4821-93d6-501b7b9f02d4", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "MEDROL", "generic": "甲泼尼龙", "dosageFormClass": "MEDROL 甲泼尼龙口服片：2、4、8、16、32 mg；另列 4 mg、21 片单位剂量 Dosepak 纸盒（当前美国公开标签所列）" }, "labelSource": { "id": "src_0f04138903f051f5", "label": "DailyMed（NLM）：MEDROL 甲泼尼龙当前美国公开标签（Pfizer；2025-11 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=39d5270b-d957-4821-93d6-501b7b9f02d4", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" }, "productRoutes": [ { "source": { "id": "src_0f04138903f051f5", "label": "DailyMed（NLM）：MEDROL 甲泼尼龙当前美国公开标签（Pfizer；2025-11 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=39d5270b-d957-4821-93d6-501b7b9f02d4", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-28", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_f57b2c410c7aaead", "label": "FDA Drugs@FDA：MEDROL NDA 011153 申请记录", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=011153", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" }, "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-08-28", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-28", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "MEDROL 是甲泼尼龙口服糖皮质激素品牌。当前美国 DailyMed 标签列出 2、4、8、16、32 mg 片剂，以及一板 21 片的 4 mg Dosepak。本页把每片毫克数、包装数量和准确 NDC 分开呈现；包装上的递减格子不是所有人的通用吃法，网页不计算个人片数、持续时间、递减、补服或停药方案。", "history": "FDA NDA 011153 和当前 DailyMed 标签为美国产品史与说明书入口。DEPO-MEDROL 注射混悬剂与 SOLU-MEDROL 注射用粉末是不同成分形式、给药途径和标签，不能仅凭 MEDROL 名称或甲泼尼龙成分并入本口服片档案。", "sourceDocuments": [ { "id": "src_0f04138903f051f5", "label": "DailyMed（NLM）：MEDROL 甲泼尼龙当前美国公开标签（Pfizer；2025-11 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=39d5270b-d957-4821-93d6-501b7b9f02d4", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" }, { "id": "src_f57b2c410c7aaead", "label": "FDA Drugs@FDA：MEDROL NDA 011153 申请记录", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=011153", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" } ], "applicationNumber": "FDA NDA 011153（MEDROL / methylprednisolone oral tablets；美国监管与当前标签档案）", "approvalTimeline": [ { "date": "1957", "title": { "zh": "MEDROL 美国初始批准年份", "en": "MEDROL U.S. initial-approval year" }, "detail": { "zh": "当前 DailyMed 标签将 MEDROL 的 Initial U.S. Approval 列为 1957。该年份定位美国品牌历史，不自动建立中国大陆或其他市场的批准、商品名、包装、供应或可替代性。", "en": "The current DailyMed label lists 1957 as MEDROL's Initial U.S. Approval. This locates U.S. brand history and does not automatically establish approval, trade name, packaging, supply or interchangeability in Mainland China or another market." }, "source": { "id": "src_0f04138903f051f5", "label": "DailyMed（NLM）：MEDROL 甲泼尼龙当前美国公开标签（Pfizer；2025-11 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=39d5270b-d957-4821-93d6-501b7b9f02d4", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" } }, { "date": "2025-11", "title": { "zh": "当前 MEDROL 美国公开标签修订", "en": "Current U.S. MEDROL public label revised" }, "detail": { "zh": "当前标签分别列出 2、4、8、16、32 mg 口服片，以及 4 mg、21 片 Dosepak 的准确 NDC 与包装展示面。该日期只定位标签版本，不是个人开始、持续、递减或停药日期。", "en": "The current label separately lists 2, 4, 8, 16 and 32 mg oral tablets plus the exact NDC and package panel for the 4 mg 21-tablet Dosepak. The date identifies a label version, not an individual's start, duration, taper or stopping date." }, "source": { "id": "src_0f04138903f051f5", "label": "DailyMed（NLM）：MEDROL 甲泼尼龙当前美国公开标签（Pfizer；2025-11 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=39d5270b-d957-4821-93d6-501b7b9f02d4", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "已链接 NDA 011153、当前标签及六个准确包装身份", "en": "NDA 011153, current label and six exact package identities linked" }, "detail": { "zh": "本页逐项保留五种每片强度、六个 NDC、瓶装片数及 4 mg Dosepak 纸盒。它用于产品身份与安全阅读，不用于鉴定真伪，也不建立库存、购买、个人片数、持续时间、递减、补服或停药方案。", "en": "The dossier separately retains five per-tablet strengths, six NDCs, bottle counts and the 4 mg Dosepak carton. It supports product identity and safety reading; it does not authenticate a product or establish stock, purchase, individual tablet count, duration, taper, missed-use or stopping instructions." } }, { "market": { "zh": "中国大陆、欧盟、日本及其他市场", "en": "Mainland China, the EU, Japan and other markets" }, "status": { "zh": "待逐项建立现行市场记录", "en": "Current market record not established" }, "detail": { "zh": "不从美国 NDA、MEDROL 名称、共同成分、片剂刻痕、毫克数、Dosepak 格子或包装图推定当地商品名、批准、包装、供应、原研/仿制关系、真伪或可替代性；每个市场须按当地现行监管资料单独核对。", "en": "No local trade name, approval, package, supply, originator/generic relationship, authenticity or interchangeability is inferred from the U.S. NDA, MEDROL name, shared ingredient, tablet score, milligrams, Dosepak rows or package image; each market requires separate review against current local regulatory material." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "Dosepak 纸盒上的格子是否适用于每个人？", "en": "Do the rows on a Dosepak carton apply to everyone?" }, "answer": { "zh": "不是。格子属于 4 mg、21 片这一准确包装身份，不能抄给另一位使用者、另一种病情、另一盒甲泼尼龙或其他激素。个人方案必须以本人处方和负责团队说明为准。", "en": "No. The rows belong to the exact 4 mg 21-tablet package identity and cannot be copied to another person, condition, methylprednisolone pack or corticosteroid. An individual plan must come from that person's prescription and treating team." } }, { "question": { "zh": "片上有刻痕，能否自行掰片或按毫克换成另一种激素？", "en": "Does a tablet score permit self-splitting or milligram conversion to another corticosteroid?" }, "answer": { "zh": "不能从刻痕或毫克数得出这种结论。刻痕在本页只作外观线索；剂型、效价、处方、疗程、递减和停药都需按准确产品及个人情况由专业人员核对。", "en": "No such conclusion follows from a score or milligram number. The score is only an appearance clue here; dosage form, potency, prescription, course, taper and stopping all require professional review of the exact product and individual context." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "dosage-forms-are-part-of-medicine-identity", "how-to-read-a-drug-label" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/medrol/", "en": "https://origindrug.com/en/drugs/medrol/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "xigduo-xr", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-30", "status": "published_traceable_archive" }, "names": { "brand": "XIGDUO XR", "generic": "达格列净/盐酸二甲双胍缓释片", "aliases": [ "Xigduo XR", "dapagliflozin and metformin hydrochloride extended-release", "dapagliflozin metformin XR", "达格列净二甲双胍缓释片", "达格列净/盐酸二甲双胍缓释片", "dapagliflozin and metformin hydrochloride", "NDA 205649", "0310-6225-60", "0310-6250-30", "0310-6260-60", "0310-6270-30", "0310-6280-30", "1074 2.5/1000", "1070 5/500", "1071 5/1000", "1072 10/500", "1073 10/1000" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "代谢", "sourceArchiveMarket": "美国 XIGDUO XR 当前 DailyMed 公开品牌标签（SPL v39；2026-08-11 生效；NDA 205649）。本档案只建立该标签中的五种准确瓶装身份，不由美国资料推定中国大陆或其他市场的商品名、批准、包装、供应、可售资格或可替代性。", "dosageFormClass": "达格列净/盐酸二甲双胍薄膜衣缓释口服片：2.5 mg/1,000 mg、5 mg/500 mg、5 mg/1,000 mg、10 mg/500 mg、10 mg/1,000 mg；五种产品均须整片吞服，不得压碎、切开或咀嚼", "dosageFormClassCode": "oral_modified_release", "route": "口服（固定复方缓释片准确产品身份字段）", "routeCode": "oral", "historicalApprovalEntry": "2014（当前美国公开标签所列 Initial U.S. Approval）", "archiveSponsorText": "AstraZeneca Pharmaceuticals LP（当前美国公开品牌标签所列）" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [ "FARXIGA", "dapagliflozin tablet", "GLUCOPHAGE", "metformin tablet", "QTERN", "dapagliflozin saxagliptin", "QTERNMET XR", "SYNJARDY", "INVOKAMET" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-xigduo-xr-dapagliflozin-2-5mg-metformin-1000mg-0310622560", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（2026-08-11 生效）", "en": "current U.S. DailyMed public label (effective 11 Aug 2026)" }, "dosageForm": { "zh": "达格列净/盐酸二甲双胍薄膜衣缓释片", "en": "dapagliflozin/metformin hydrochloride film-coated extended-release tablet" }, "route": { "zh": "口服；缓释片必须整片吞服", "en": "oral; extended-release tablet must be swallowed whole" }, "routeCodes": [ "oral" ], "productCode": "NDC 0310-6225-60", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片达格列净 2.5 mg + 盐酸二甲双胍 1,000 mg；60 片瓶装", "en": "2.5 mg dapagliflozin + 1,000 mg metformin HCl per tablet; 60-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=image-06.jpg&setid=ac8a0f7b-9f69-4495-abbc-3a47cd75a859", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "达格列净", "en": "dapagliflozin" }, "value": 2.5, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片第一种活性成分标示量；不是个人片数或换算指令", "en": "labelled amount of the first active ingredient per tablet; not an individual tablet count or conversion instruction" } }, { "ingredient": { "zh": "盐酸二甲双胍", "en": "metformin hydrochloride" }, "value": 1000, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片第二种活性成分标示量；不是个人片数或换算指令", "en": "labelled amount of the second active ingredient per tablet; not an individual tablet count or conversion instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "塑料瓶", "en": "plastic bottle" }, "fill": null, "countPerPackage": 60, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": null, "package": { "count": 60, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "浅棕至棕色", "en": "light brown to brown" }, "shape": { "zh": "双凸椭圆形", "en": "biconvex oval" }, "imprint": "1074 / 2.5/1000", "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_32bee81e299db602", "label": "DailyMed（NLM）：XIGDUO XR 2.5 mg/1,000 mg、NDC 0310-6225-60、60 片瓶装美国当前标签面板", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ac8a0f7b-9f69-4495-abbc-3a47cd75a859", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-xigduo-xr-dapagliflozin-5mg-metformin-500mg-0310625030", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（2026-08-11 生效）", "en": "current U.S. DailyMed public label (effective 11 Aug 2026)" }, "dosageForm": { "zh": "达格列净/盐酸二甲双胍薄膜衣缓释片", "en": "dapagliflozin/metformin hydrochloride film-coated extended-release tablet" }, "route": { "zh": "口服；缓释片必须整片吞服", "en": "oral; extended-release tablet must be swallowed whole" }, "routeCodes": [ "oral" ], "productCode": "NDC 0310-6250-30", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片达格列净 5 mg + 盐酸二甲双胍 500 mg；30 片瓶装", "en": "5 mg dapagliflozin + 500 mg metformin HCl per tablet; 30-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=image-07.jpg&setid=ac8a0f7b-9f69-4495-abbc-3a47cd75a859", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "达格列净", "en": "dapagliflozin" }, "value": 5, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片第一种活性成分标示量；不是个人片数或换算指令", "en": "labelled amount of the first active ingredient per tablet; not an individual tablet count or conversion instruction" } }, { "ingredient": { "zh": "盐酸二甲双胍", "en": "metformin hydrochloride" }, "value": 500, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片第二种活性成分标示量；不是个人片数或换算指令", "en": "labelled amount of the second active ingredient per tablet; not an individual tablet count or conversion instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "塑料瓶", "en": "plastic bottle" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": null, "package": { "count": 30, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "橙色", "en": "orange" }, "shape": { "zh": "双凸胶囊形", "en": "biconvex capsule-shaped" }, "imprint": "1070 / 5/500", "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_32bee81e299db602", "label": "DailyMed（NLM）：XIGDUO XR 5 mg/500 mg、NDC 0310-6250-30、30 片瓶装美国当前标签面板", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ac8a0f7b-9f69-4495-abbc-3a47cd75a859", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-xigduo-xr-dapagliflozin-5mg-metformin-1000mg-0310626060", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（2026-08-11 生效）", "en": "current U.S. DailyMed public label (effective 11 Aug 2026)" }, "dosageForm": { "zh": "达格列净/盐酸二甲双胍薄膜衣缓释片", "en": "dapagliflozin/metformin hydrochloride film-coated extended-release tablet" }, "route": { "zh": "口服；缓释片必须整片吞服", "en": "oral; extended-release tablet must be swallowed whole" }, "routeCodes": [ "oral" ], "productCode": "NDC 0310-6260-60", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片达格列净 5 mg + 盐酸二甲双胍 1,000 mg；60 片瓶装", "en": "5 mg dapagliflozin + 1,000 mg metformin HCl per tablet; 60-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=image-08.jpg&setid=ac8a0f7b-9f69-4495-abbc-3a47cd75a859", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "达格列净", "en": "dapagliflozin" }, "value": 5, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片第一种活性成分标示量；不是个人片数或换算指令", "en": "labelled amount of the first active ingredient per tablet; not an individual tablet count or conversion instruction" } }, { "ingredient": { "zh": "盐酸二甲双胍", "en": "metformin hydrochloride" }, "value": 1000, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片第二种活性成分标示量；不是个人片数或换算指令", "en": "labelled amount of the second active ingredient per tablet; not an individual tablet count or conversion instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "塑料瓶", "en": "plastic bottle" }, "fill": null, "countPerPackage": 60, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": null, "package": { "count": 60, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "粉红至深粉红色", "en": "pink to dark pink" }, "shape": { "zh": "双凸椭圆形", "en": "biconvex oval" }, "imprint": "1071 / 5/1000", "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_32bee81e299db602", "label": "DailyMed（NLM）：XIGDUO XR 5 mg/1,000 mg、NDC 0310-6260-60、60 片瓶装美国当前标签面板", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ac8a0f7b-9f69-4495-abbc-3a47cd75a859", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-xigduo-xr-dapagliflozin-10mg-metformin-500mg-0310627030", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（2026-08-11 生效）", "en": "current U.S. DailyMed public label (effective 11 Aug 2026)" }, "dosageForm": { "zh": "达格列净/盐酸二甲双胍薄膜衣缓释片", "en": "dapagliflozin/metformin hydrochloride film-coated extended-release tablet" }, "route": { "zh": "口服；缓释片必须整片吞服", "en": "oral; extended-release tablet must be swallowed whole" }, "routeCodes": [ "oral" ], "productCode": "NDC 0310-6270-30", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片达格列净 10 mg + 盐酸二甲双胍 500 mg；30 片瓶装", "en": "10 mg dapagliflozin + 500 mg metformin HCl per tablet; 30-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=image-09.jpg&setid=ac8a0f7b-9f69-4495-abbc-3a47cd75a859", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "达格列净", "en": "dapagliflozin" }, "value": 10, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片第一种活性成分标示量；不是个人片数或换算指令", "en": "labelled amount of the first active ingredient per tablet; not an individual tablet count or conversion instruction" } }, { "ingredient": { "zh": "盐酸二甲双胍", "en": "metformin hydrochloride" }, "value": 500, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片第二种活性成分标示量；不是个人片数或换算指令", "en": "labelled amount of the second active ingredient per tablet; not an individual tablet count or conversion instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "塑料瓶", "en": "plastic bottle" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": null, "package": { "count": 30, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "粉红色", "en": "pink" }, "shape": { "zh": "双凸胶囊形", "en": "biconvex capsule-shaped" }, "imprint": "1072 / 10/500", "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_32bee81e299db602", "label": "DailyMed（NLM）：XIGDUO XR 10 mg/500 mg、NDC 0310-6270-30、30 片瓶装美国当前标签面板", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ac8a0f7b-9f69-4495-abbc-3a47cd75a859", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-xigduo-xr-dapagliflozin-10mg-metformin-1000mg-0310628030", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（2026-08-11 生效）", "en": "current U.S. DailyMed public label (effective 11 Aug 2026)" }, "dosageForm": { "zh": "达格列净/盐酸二甲双胍薄膜衣缓释片", "en": "dapagliflozin/metformin hydrochloride film-coated extended-release tablet" }, "route": { "zh": "口服；缓释片必须整片吞服", "en": "oral; extended-release tablet must be swallowed whole" }, "routeCodes": [ "oral" ], "productCode": "NDC 0310-6280-30", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片达格列净 10 mg + 盐酸二甲双胍 1,000 mg；30 片瓶装", "en": "10 mg dapagliflozin + 1,000 mg metformin HCl per tablet; 30-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=image-10.jpg&setid=ac8a0f7b-9f69-4495-abbc-3a47cd75a859", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "达格列净", "en": "dapagliflozin" }, "value": 10, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片第一种活性成分标示量；不是个人片数或换算指令", "en": "labelled amount of the first active ingredient per tablet; not an individual tablet count or conversion instruction" } }, { "ingredient": { "zh": "盐酸二甲双胍", "en": "metformin hydrochloride" }, "value": 1000, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片第二种活性成分标示量；不是个人片数或换算指令", "en": "labelled amount of the second active ingredient per tablet; not an individual tablet count or conversion instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "塑料瓶", "en": "plastic bottle" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": null, "package": { "count": 30, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "黄色至深黄色", "en": "yellow to dark yellow" }, "shape": { "zh": "双凸椭圆形", "en": "biconvex oval" }, "imprint": "1073 / 10/1000", "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_32bee81e299db602", "label": "DailyMed（NLM）：XIGDUO XR 10 mg/1,000 mg、NDC 0310-6280-30、30 片瓶装美国当前标签面板", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ac8a0f7b-9f69-4495-abbc-3a47cd75a859", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-xigduo-xr-dapagliflozin-5mg-metformin-500mg-0310625030", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=image-07.jpg&setid=ac8a0f7b-9f69-4495-abbc-3a47cd75a859", "alt": "XIGDUO XR 达格列净 5 mg/盐酸二甲双胍 500 mg、NDC 0310-6250-30、30 片瓶装的美国 DailyMed 当前标签展示面", "archiveMarket": "美国", "labelVersion": "DailyMed SPL v39；2026-08-11 生效", "presentation": "XIGDUO XR 每片达格列净 5 mg/盐酸二甲双胍 500 mg，NDC 0310-6250-30，30 片瓶装标签展示面。", "notice": "此图只对应所引美国标签中的 5 mg/500 mg、NDC 0310-6250-30、30 片瓶装；不代表另四种强度、其他市场包装或当前可得性，不用于鉴定真伪，也不生成个人片数、换药或联合用药方案。", "source": { "id": "src_32bee81e299db602", "label": "DailyMed（NLM）：XIGDUO XR 5 mg/500 mg、NDC 0310-6250-30、30 片瓶装美国当前标签面板", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ac8a0f7b-9f69-4495-abbc-3a47cd75a859", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "XIGDUO XR 说明书放大阅读：一片有两种成分，缓释片不能掰、压碎或咀嚼", "en": "XIGDUO XR label reading: two ingredients in one tablet, and the extended-release tablet must not be cut, crushed or chewed" }, "summary": { "zh": "当前美国标签把五种强度、两个成分、包装数量和整片吞服要求分别列出。读者首先要确认自己手里是哪一种准确产品：不要把两个 mg 数字相加，不要按照片估算后掰开半片，也不要再自行加用 FARXIGA/达格列净与二甲双胍产品。", "en": "The current U.S. label separately lists five strengths, two ingredients, pack count and the whole-tablet requirement. First identify the exact product in hand: do not add the two milligram numbers, estimate and cut a half-tablet from appearance, or self-add FARXIGA/dapagliflozin or metformin products." }, "checks": [ { "zh": "例如“5 mg/500 mg”表示每片含达格列净 5 mg 和盐酸二甲双胍 500 mg；它不是早晚各一个数字，不是 505 mg 的可比强度，也不能与另一种药的 mg 直接比较。", "en": "For example, 5 mg/500 mg means 5 mg dapagliflozin and 500 mg metformin HCl in each tablet. The two figures are not morning/evening amounts, not a comparable 505 mg strength and not directly comparable with another medicine's milligrams." }, { "zh": "标签明确要求整片吞服，不得压碎、切开或咀嚼；排便中偶尔看到像药片的柔软物可能是非活性成分残留，但网页不能仅凭这一现象判断个人吸收或补服。", "en": "The label requires swallowing whole and says not to crush, cut or chew. A soft mass resembling the tablet can occasionally appear in stool from inactive ingredients, but the site cannot use that observation to judge an individual's absorption or make-up use." }, { "zh": "一片已经含达格列净和二甲双胍。若药单里还有 FARXIGA、达格列净、GLUCOPHAGE、二甲双胍、JANUMET 或其他复方降糖药，先视为需要核对的共同成分线索；不要自行叠加、轮换或停掉其中一盒。", "en": "One tablet already contains dapagliflozin and metformin. FARXIGA, dapagliflozin, GLUCOPHAGE, metformin, JANUMET or another glucose-lowering combination on the same list is a shared-ingredient cue requiring review; do not self-combine, alternate or stop a pack." }, { "zh": "标签涉及乳酸性酸中毒、酮症酸中毒、脱水/低血压、肾功能、泌尿生殖感染、手术与含碘造影等重要边界。出现呼吸困难、严重虚弱、持续呕吐、明显意识变化、严重腹痛或其他急性重症时，应立即使用当地急救渠道并带上全部药盒。", "en": "The label covers lactic acidosis, ketoacidosis, volume depletion/hypotension, kidney function, genitourinary infection, surgery and iodinated contrast. Breathing difficulty, severe weakness, persistent vomiting, marked altered awareness, severe abdominal pain or another acute serious concern requires local emergency help with every medicine pack." } ], "source": { "id": "src_32bee81e299db602", "label": "DailyMed（NLM）：XIGDUO XR 当前美国公开标签与 FDA 批准患者用药指南（2026-08 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ac8a0f7b-9f69-4495-abbc-3a47cd75a859", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "两种成分怎样配合：达格列净影响肾脏葡萄糖重吸收，二甲双胍影响肝糖生成与胰岛素敏感性", "en": "How the two ingredients work: dapagliflozin affects renal glucose reabsorption, while metformin affects hepatic glucose production and insulin sensitivity" }, "summary": { "zh": "标签将达格列净列为 SGLT2 抑制剂，将二甲双胍列为双胍类。两条作用路径解释为何这是固定复方，但不能推导个人该选哪种强度、是否适合、何时停用或是否需要与其他降糖药联合。", "en": "The label identifies dapagliflozin as an SGLT2 inhibitor and metformin as a biguanide. The two pathways explain the fixed combination but cannot determine an individual's strength, suitability, interruption or combination with another glucose-lowering medicine." }, "checks": [ { "zh": "“两种机制互补”不是把 FARXIGA 和二甲双胍自行拼成 XIGDUO XR 的许可；固定复方的缓释结构、成分量、标签和监测边界属于准确产品。", "en": "“Complementary mechanisms” does not permit self-assembling XIGDUO XR from FARXIGA and metformin; the fixed combination's extended-release design, ingredient amounts, label and monitoring boundaries belong to the exact product." }, { "zh": "肾脏和肝脏相关机制提示为什么肾功能、脱水、饮食减少、感染、饮酒、手术或造影前后需要专业核对，但网页不会据一次血糖、体重或化验值选择强度。", "en": "Kidney- and liver-related mechanisms help explain why renal function, dehydration, reduced intake, infection, alcohol, surgery or contrast procedures require professional review, but the site does not select a strength from one glucose, weight or laboratory value." }, { "zh": "基因筛查不是网页替个人选择这款药的默认答案。个体适用性要结合诊断、肾肝功能、完整药单、既往反应和目标市场现行说明书，由负责团队判断。", "en": "Genetic screening is not the site's default answer for choosing this medicine. Individual suitability requires diagnosis, renal and hepatic function, the complete medicine list, prior response and the current target-market label, reviewed by the treating team." } ], "source": { "id": "src_32bee81e299db602", "label": "DailyMed（NLM）：XIGDUO XR 当前美国公开标签（12.1 Mechanism of Action）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ac8a0f7b-9f69-4495-abbc-3a47cd75a859", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "XIGDUO XR", "generic": "达格列净/盐酸二甲双胍缓释片", "dosageFormClass": "达格列净/盐酸二甲双胍薄膜衣缓释口服片：2.5 mg/1,000 mg、5 mg/500 mg、5 mg/1,000 mg、10 mg/500 mg、10 mg/1,000 mg；五种产品均须整片吞服，不得压碎、切开或咀嚼" }, "labelSource": { "id": "src_32bee81e299db602", "label": "DailyMed（NLM）：XIGDUO XR 当前美国公开品牌标签、五种包装面板与 Medication Guide（SPL v39；2026-08-11 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ac8a0f7b-9f69-4495-abbc-3a47cd75a859", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "productRoutes": [ { "source": { "id": "src_32bee81e299db602", "label": "DailyMed（NLM）：XIGDUO XR 当前美国公开品牌标签、五种包装面板与 Medication Guide（SPL v39；2026-08-11 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ac8a0f7b-9f69-4495-abbc-3a47cd75a859", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-30", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-30", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "XIGDUO XR 一片同时含达格列净和盐酸二甲双胍缓释成分。包装上的两个 mg 数字分别属于两种成分，不是早晚片数、相加后的总强度，也不能用来与 FARXIGA、GLUCOPHAGE、其他二甲双胍或其他 SGLT2 产品自行拼接。当前美国标签列五种瓶装产品，并明确缓释片必须整片吞服，不得压碎、切开或咀嚼。网页只帮助认清准确产品、成分、每片标示量和官方说明书，不生成个人片数、换药、补服或停药方案。", "history": "FDA/NLM 当前公开标签记录 XIGDUO XR 的美国初始批准年份为 2014，当前 SPL 于 2026-08-11 生效。该固定复方不能并入单方 FARXIGA 或单方二甲双胍档案；同一成分重叠反而是需要带完整药单给药师或开方团队核对的线索。", "sourceDocuments": [ { "id": "src_32bee81e299db602", "label": "DailyMed（NLM）：XIGDUO XR 当前美国公开品牌标签、五种包装面板与 Medication Guide（SPL v39；2026-08-11 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ac8a0f7b-9f69-4495-abbc-3a47cd75a859", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, { "id": "src_94dd7b6171dec015", "label": "FDA：糖尿病药品公众信息页（固定复方 XIGDUO XR 成分核对入口）", "url": "https://www.fda.gov/consumers/womens-health-topics/women-and-diabetes-diabetes-medicines", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_public_guidance", "documentKind": "regulatory_guidance", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" } ], "applicationNumber": "FDA NDA 205649（XIGDUO XR；达格列净/盐酸二甲双胍缓释片）", "approvalTimeline": [ { "date": "2014-10-29", "title": { "zh": "美国 XIGDUO XR NDA 205649 产品记录", "en": "U.S. XIGDUO XR NDA 205649 product record" }, "detail": { "zh": "当前 DailyMed 标签把 XIGDUO XR、NDA 205649、2014 年美国初始批准及 2014-10-29 营销起始记录相连。该节点只建立美国产品史，不推定其他市场批准、包装或供应。", "en": "The current DailyMed label links XIGDUO XR, NDA 205649, initial U.S. approval in 2014 and a 29 Oct 2014 marketing-start record. This establishes U.S. product history only and does not infer another market's approval, pack or supply." }, "source": { "id": "src_32bee81e299db602", "label": "DailyMed（NLM）：XIGDUO XR 当前美国公开标签（NDA 205649 与产品记录）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ac8a0f7b-9f69-4495-abbc-3a47cd75a859", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" } }, { "date": "2026-08-11", "title": { "zh": "当前 DailyMed SPL v39 生效", "en": "Current DailyMed SPL v39 became effective" }, "detail": { "zh": "本页放大说明书、患者指南、五种准确瓶装身份、整片吞服及复方成分边界均以该当前公开标签为主要来源；标签日期不是药店库存或个人用药结论。", "en": "This page's enlarged label, Medication Guide, five exact bottle identities, whole-tablet rule and fixed-combination boundary use this current public label as the primary source. A label date is not pharmacy stock or an individual-use conclusion." }, "source": { "id": "src_32bee81e299db602", "label": "DailyMed（NLM）：XIGDUO XR 当前美国公开品牌标签（SPL v39；2026-08-11 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ac8a0f7b-9f69-4495-abbc-3a47cd75a859", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "当前公开品牌标签与五种准确瓶装身份已建立", "en": "Current public brand label and five exact bottle identities established" }, "detail": { "zh": "记录五种每片双成分强度、NDC、瓶装数量、颜色、形状、刻印和官方标签面板；不表示任何具体渠道有库存，不用于真伪、购买或个人片数判断。", "en": "Records both per-tablet ingredient amounts, NDC, bottle count, colour, shape, imprint and official label panel for five products. It does not establish stock at a particular channel and is not an authenticity, purchase or individual tablet-count decision." } }, { "market": { "zh": "中国大陆、欧盟、日本及其他市场", "en": "Mainland China, EU, Japan and other markets" }, "status": { "zh": "待逐项建立现行监管产品记录", "en": "Current regulatory product records not established" }, "detail": { "zh": "不从美国商品名、共同成分、NDA 或包装推定当地商品名、批准、持有人、规格、供应、原研/参比关系或可替代性；须按当地现行监管文件逐产品核对。", "en": "No local trade name, approval, holder, strength, supply, originator/reference relationship or interchangeability is inferred from the U.S. brand, shared ingredients, NDA or packs; each product requires current local regulatory review." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "5 mg/500 mg 是 505 mg，还是一天两个时间的用量？", "en": "Does 5 mg/500 mg mean 505 mg, or two times of day?" }, "answer": { "zh": "都不是。它表示一片里分别有达格列净 5 mg 和盐酸二甲双胍 500 mg。两个数字属于两种成分，不能相加后与别的药比较，也不能推导个人片数或频次。", "en": "Neither. It means one tablet contains 5 mg dapagliflozin and 500 mg metformin HCl. The two figures belong to two ingredients and cannot be added for comparison with another medicine or used to derive an individual tablet count or frequency." } }, { "question": { "zh": "药片太大，可以掰一半、压碎或嚼碎吗？", "en": "Can a large tablet be halved, crushed or chewed?" }, "answer": { "zh": "当前标签明确要求整片吞服，不得压碎、切开或咀嚼。吞咽困难时不要自行破坏缓释结构，应携带准确药盒联系开方团队或药师讨论可行产品。", "en": "The current label explicitly requires swallowing whole and says not to crush, cut or chew. If swallowing is difficult, do not damage the extended-release design; take the exact pack to the prescriber or pharmacist to discuss an appropriate product." } }, { "question": { "zh": "已经吃 XIGDUO XR，还能再吃 FARXIGA 或二甲双胍吗？", "en": "Can FARXIGA or metformin be added when XIGDUO XR is already used?" }, "answer": { "zh": "网页不能决定联用。XIGDUO XR 已含达格列净和盐酸二甲双胍；药单中再出现共同成分必须优先核对，不能自行叠加、轮换或停掉其中一盒。", "en": "A webpage cannot decide combination use. XIGDUO XR already contains dapagliflozin and metformin HCl. Another shared ingredient on the medicine list requires priority review, not self-combination, alternation or stopping a pack." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "dosage-forms-are-part-of-medicine-identity", "how-to-read-a-drug-label", "generic-drugs-and-bioequivalence" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/xigduo-xr/", "en": "https://origindrug.com/en/drugs/xigduo-xr/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "synjardy-xr", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-30", "status": "published_traceable_archive" }, "names": { "brand": "SYNJARDY XR", "generic": "恩格列净/盐酸二甲双胍缓释片", "aliases": [ "Synjardy XR", "empagliflozin and metformin hydrochloride extended-release", "empagliflozin metformin XR", "恩格列净二甲双胍缓释片", "恩格列净/盐酸二甲双胍缓释片", "empagliflozin and metformin hydrochloride", "NDA 208658", "0597-0280-73", "0597-0290-74", "0597-0295-88", "0597-0300-45", "S10 1000", "S5 1000", "S25 1000", "S12 1000" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "代谢", "sourceArchiveMarket": "美国 SYNJARDY XR 当前 DailyMed 公开品牌标签（SPL v18；2026-08-11 更新，2026-08-21 发布；NDA 208658）。本档案精确建立标签展示的四种代表性瓶装面板；另四个在标签包装表中列出的瓶装 NDC 不由没有对应展示面的图片推定。欧盟 Synjardy 为恩格列净/二甲双胍普通片产品资料，不能与美国 SYNJARDY XR 缓释片合并。", "dosageFormClass": "恩格列净/盐酸二甲双胍薄膜衣缓释口服片：5 mg/1,000 mg、10 mg/1,000 mg、12.5 mg/1,000 mg、25 mg/1,000 mg；美国标签要求整片吞服，不得掰开、压碎、溶解或咀嚼", "dosageFormClassCode": "oral_modified_release", "route": "口服（固定复方缓释片准确产品身份字段）", "routeCode": "oral", "historicalApprovalEntry": "2015（当前美国公开标签所列 Initial U.S. Approval）", "archiveSponsorText": "Boehringer Ingelheim Pharmaceuticals, Inc.（当前美国公开品牌标签所列）" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [ "JARDIANCE", "empagliflozin tablet", "GLUCOPHAGE", "metformin tablet", "SYNJARDY immediate-release", "SYNJARDY tablets", "GLYXAMBI", "TRIJARDY XR", "XIGDUO XR", "INVOKAMET XR" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-synjardy-xr-empagliflozin-10mg-metformin-1000mg-0597028073", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（SPL v18；2026-08-21 发布）", "en": "current U.S. DailyMed public label (SPL v18; published 21 Aug 2026)" }, "dosageForm": { "zh": "恩格列净/盐酸二甲双胍薄膜衣缓释片", "en": "empagliflozin/metformin hydrochloride film-coated extended-release tablet" }, "route": { "zh": "口服；缓释片必须整片吞服", "en": "oral; extended-release tablet must be swallowed whole" }, "routeCodes": [ "oral" ], "productCode": "NDC 0597-0280-73", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片恩格列净 10 mg + 盐酸二甲双胍 1,000 mg；30 片瓶装", "en": "10 mg empagliflozin + 1,000 mg metformin HCl per tablet; 30-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=synjardy-09.jpg&setid=8006ba29-ee3a-f852-a9bb-c8ec9b41cf66", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "恩格列净", "en": "empagliflozin" }, "value": 10, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片第一种活性成分标示量；不是个人片数或换算指令", "en": "labelled amount of the first active ingredient per tablet; not an individual tablet count or conversion instruction" } }, { "ingredient": { "zh": "盐酸二甲双胍", "en": "metformin hydrochloride" }, "value": 1000, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片第二种活性成分标示量；不是个人片数或换算指令", "en": "labelled amount of the second active ingredient per tablet; not an individual tablet count or conversion instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "塑料瓶", "en": "plastic bottle" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": null, "package": { "count": 30, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "橙色", "en": "orange" }, "shape": { "zh": "椭圆形、双凸、无刻痕薄膜衣片", "en": "oval, biconvex, unscored film-coated tablet" }, "imprint": "BI symbol / S10 / 1000 M", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_527bcad202bf135e", "label": "DailyMed（NLM）：SYNJARDY XR 10 mg/1,000 mg、NDC 0597-0280-73、30 片瓶装美国当前标签面板", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8006ba29-ee3a-f852-a9bb-c8ec9b41cf66", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-synjardy-xr-empagliflozin-5mg-metformin-1000mg-0597029074", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（SPL v18；2026-08-21 发布）", "en": "current U.S. DailyMed public label (SPL v18; published 21 Aug 2026)" }, "dosageForm": { "zh": "恩格列净/盐酸二甲双胍薄膜衣缓释片", "en": "empagliflozin/metformin hydrochloride film-coated extended-release tablet" }, "route": { "zh": "口服；缓释片必须整片吞服", "en": "oral; extended-release tablet must be swallowed whole" }, "routeCodes": [ "oral" ], "productCode": "NDC 0597-0290-74", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片恩格列净 5 mg + 盐酸二甲双胍 1,000 mg；60 片瓶装", "en": "5 mg empagliflozin + 1,000 mg metformin HCl per tablet; 60-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=synjardy-10.jpg&setid=8006ba29-ee3a-f852-a9bb-c8ec9b41cf66", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "恩格列净", "en": "empagliflozin" }, "value": 5, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片第一种活性成分标示量；不是个人片数或换算指令", "en": "labelled amount of the first active ingredient per tablet; not an individual tablet count or conversion instruction" } }, { "ingredient": { "zh": "盐酸二甲双胍", "en": "metformin hydrochloride" }, "value": 1000, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片第二种活性成分标示量；不是个人片数或换算指令", "en": "labelled amount of the second active ingredient per tablet; not an individual tablet count or conversion instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "塑料瓶", "en": "plastic bottle" }, "fill": null, "countPerPackage": 60, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": null, "package": { "count": 60, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "橄榄绿色", "en": "olive green" }, "shape": { "zh": "椭圆形、双凸、无刻痕薄膜衣片", "en": "oval, biconvex, unscored film-coated tablet" }, "imprint": "BI symbol / S5 / 1000 M", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_527bcad202bf135e", "label": "DailyMed（NLM）：SYNJARDY XR 5 mg/1,000 mg、NDC 0597-0290-74、60 片瓶装美国当前标签面板", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8006ba29-ee3a-f852-a9bb-c8ec9b41cf66", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-synjardy-xr-empagliflozin-25mg-metformin-1000mg-0597029588", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（SPL v18；2026-08-21 发布）", "en": "current U.S. DailyMed public label (SPL v18; published 21 Aug 2026)" }, "dosageForm": { "zh": "恩格列净/盐酸二甲双胍薄膜衣缓释片", "en": "empagliflozin/metformin hydrochloride film-coated extended-release tablet" }, "route": { "zh": "口服；缓释片必须整片吞服", "en": "oral; extended-release tablet must be swallowed whole" }, "routeCodes": [ "oral" ], "productCode": "NDC 0597-0295-88", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片恩格列净 25 mg + 盐酸二甲双胍 1,000 mg；30 片瓶装", "en": "25 mg empagliflozin + 1,000 mg metformin HCl per tablet; 30-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=synjardy-11.jpg&setid=8006ba29-ee3a-f852-a9bb-c8ec9b41cf66", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "恩格列净", "en": "empagliflozin" }, "value": 25, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片第一种活性成分标示量；不是个人片数或换算指令", "en": "labelled amount of the first active ingredient per tablet; not an individual tablet count or conversion instruction" } }, { "ingredient": { "zh": "盐酸二甲双胍", "en": "metformin hydrochloride" }, "value": 1000, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片第二种活性成分标示量；不是个人片数或换算指令", "en": "labelled amount of the second active ingredient per tablet; not an individual tablet count or conversion instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "塑料瓶", "en": "plastic bottle" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": null, "package": { "count": 30, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "浅绿色", "en": "light green" }, "shape": { "zh": "椭圆形、双凸、无刻痕薄膜衣片", "en": "oval, biconvex, unscored film-coated tablet" }, "imprint": "BI symbol / S25 / 1000 M", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_527bcad202bf135e", "label": "DailyMed（NLM）：SYNJARDY XR 25 mg/1,000 mg、NDC 0597-0295-88、30 片瓶装美国当前标签面板", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8006ba29-ee3a-f852-a9bb-c8ec9b41cf66", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-synjardy-xr-empagliflozin-12-5mg-metformin-1000mg-0597030045", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（SPL v18；2026-08-21 发布）", "en": "current U.S. DailyMed public label (SPL v18; published 21 Aug 2026)" }, "dosageForm": { "zh": "恩格列净/盐酸二甲双胍薄膜衣缓释片", "en": "empagliflozin/metformin hydrochloride film-coated extended-release tablet" }, "route": { "zh": "口服；缓释片必须整片吞服", "en": "oral; extended-release tablet must be swallowed whole" }, "routeCodes": [ "oral" ], "productCode": "NDC 0597-0300-45", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片恩格列净 12.5 mg + 盐酸二甲双胍 1,000 mg；60 片瓶装", "en": "12.5 mg empagliflozin + 1,000 mg metformin HCl per tablet; 60-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=synjardy-12.jpg&setid=8006ba29-ee3a-f852-a9bb-c8ec9b41cf66", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "恩格列净", "en": "empagliflozin" }, "value": 12.5, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片第一种活性成分标示量；不是个人片数或换算指令", "en": "labelled amount of the first active ingredient per tablet; not an individual tablet count or conversion instruction" } }, { "ingredient": { "zh": "盐酸二甲双胍", "en": "metformin hydrochloride" }, "value": 1000, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片第二种活性成分标示量；不是个人片数或换算指令", "en": "labelled amount of the second active ingredient per tablet; not an individual tablet count or conversion instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "塑料瓶", "en": "plastic bottle" }, "fill": null, "countPerPackage": 60, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": null, "package": { "count": 60, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "蓝色", "en": "blue" }, "shape": { "zh": "椭圆形、双凸、无刻痕薄膜衣片", "en": "oval, biconvex, unscored film-coated tablet" }, "imprint": "BI symbol / S12 / 1000 M", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_527bcad202bf135e", "label": "DailyMed（NLM）：SYNJARDY XR 12.5 mg/1,000 mg、NDC 0597-0300-45、60 片瓶装美国当前标签面板", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8006ba29-ee3a-f852-a9bb-c8ec9b41cf66", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-synjardy-xr-empagliflozin-10mg-metformin-1000mg-0597028073", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=synjardy-09.jpg&setid=8006ba29-ee3a-f852-a9bb-c8ec9b41cf66", "alt": "SYNJARDY XR 恩格列净 10 mg/盐酸二甲双胍 1,000 mg、NDC 0597-0280-73、30 片瓶装的美国 DailyMed 当前标签展示面", "archiveMarket": "美国", "labelVersion": "DailyMed SPL v18；2026-08-21 发布", "presentation": "SYNJARDY XR 每片恩格列净 10 mg/盐酸二甲双胍 1,000 mg，NDC 0597-0280-73，30 片瓶装标签展示面。", "notice": "此图只对应所引美国标签中的 10 mg/1,000 mg、NDC 0597-0280-73、30 片瓶装；不代表另三张展示面、同强度其他瓶装 NDC、SYNJARDY 普通片、其他市场包装或当前可得性，不用于鉴定真伪，也不生成个人片数。", "source": { "id": "src_527bcad202bf135e", "label": "DailyMed（NLM）：SYNJARDY XR 10 mg/1,000 mg、NDC 0597-0280-73、30 片瓶装美国当前标签面板", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8006ba29-ee3a-f852-a9bb-c8ec9b41cf66", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "SYNJARDY XR 说明书放大阅读：一片两种成分，缓释片不得掰开、压碎、溶解或咀嚼", "en": "SYNJARDY XR label reading: two ingredients in one tablet; do not split, crush, dissolve or chew the extended-release tablet" }, "summary": { "zh": "当前美国标签列四种强度，每片二甲双胍部分均为 1,000 mg，恩格列净分别为 5、10、12.5 或 25 mg。先确认准确 NDC 和两个成分数字，不要相加、按外观估算后掰片，或再自行加用 JARDIANCE、恩格列净、GLUCOPHAGE 或二甲双胍产品。", "en": "The current U.S. label lists four strengths. Every tablet contains 1,000 mg metformin HCl, while empagliflozin is 5, 10, 12.5 or 25 mg. Confirm the exact NDC and both ingredient figures; do not add the numbers, estimate and split from appearance, or self-add JARDIANCE/empagliflozin, GLUCOPHAGE or metformin products." }, "checks": [ { "zh": "例如“10 mg/1,000 mg”表示每片含恩格列净 10 mg 和盐酸二甲双胍 1,000 mg；它不是 1,010 mg 的可比强度，也不是早晚两个时间。", "en": "For example, 10 mg/1,000 mg means 10 mg empagliflozin and 1,000 mg metformin HCl per tablet. It is not a comparable 1,010 mg strength or two times of day." }, { "zh": "标签要求早晨随餐整片吞服，并明确不得掰开、压碎、溶解或咀嚼。网页只解释标签文字，不根据这一句替任何人选择时间、频次、片数或替代剂型。", "en": "The label says to swallow whole with a meal in the morning and not to split, crush, dissolve or chew. The site explains that text only; it does not select an individual's time, frequency, tablet count or alternative dosage form." }, { "zh": "黑框警示涉及二甲双胍相关乳酸性酸中毒，标签还涉及酮症酸中毒、脱水/低血压、肾功能、泌尿生殖感染、手术与含碘造影。65 岁及以上、多病或多药使用者尤其应带完整药单核对。", "en": "The boxed warning covers metformin-associated lactic acidosis, while the label also covers ketoacidosis, volume depletion/hypotension, kidney function, genitourinary infection, surgery and iodinated contrast. People aged 65 or older and those with several conditions or medicines should especially bring the complete medicine list for review." }, { "zh": "呼吸困难、严重虚弱、持续呕吐、明显意识变化、严重腹痛或其他急性重症需要立即使用当地急救渠道并带上全部药盒；不要等待网页判断是否停药或补服。", "en": "Breathing difficulty, severe weakness, persistent vomiting, marked altered awareness, severe abdominal pain or another acute serious concern requires local emergency help with every medicine pack. Do not wait for a webpage to decide interruption or make-up use." } ], "source": { "id": "src_527bcad202bf135e", "label": "DailyMed（NLM）：SYNJARDY XR 当前美国公开标签与 Medication Guide（2026-08 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8006ba29-ee3a-f852-a9bb-c8ec9b41cf66", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "两种成分怎样配合：恩格列净影响肾脏葡萄糖重吸收，二甲双胍影响肝糖生成与胰岛素敏感性", "en": "How the ingredients work: empagliflozin affects renal glucose reabsorption, while metformin affects hepatic glucose production and insulin sensitivity" }, "summary": { "zh": "标签把恩格列净列为 SGLT2 抑制剂，把二甲双胍列为双胍类。两条作用路径解释固定复方的组成，但不能推导个人该选哪种强度、是否适合、何时停用或是否应与其他降糖药联合。", "en": "The label identifies empagliflozin as an SGLT2 inhibitor and metformin as a biguanide. The two pathways explain the fixed combination but cannot determine an individual's strength, suitability, interruption or combination with another glucose-lowering medicine." }, "checks": [ { "zh": "“两种机制互补”不是把 JARDIANCE 和二甲双胍自行拼成 SYNJARDY XR 的许可；缓释核心、即时释放包衣、成分量、标签和监测边界属于准确产品。", "en": "“Complementary mechanisms” do not permit self-assembling SYNJARDY XR from JARDIANCE and metformin. The extended-release core, immediate-release coating, ingredient amounts, label and monitoring boundaries belong to the exact product." }, { "zh": "标签说明该片由盐酸二甲双胍缓释核心和含即时释放恩格列净的外层组成；这正是不能仅按毫克数或外观看成普通片、拆分片或两盒单方的原因。", "en": "The label states that the tablet has a metformin HCl extended-release core coated with immediate-release empagliflozin. That is why milligram figures or appearance cannot turn it into an immediate-release tablet, a divided tablet or two single-ingredient packs." }, { "zh": "基因筛查不是网页替个人选择这款药的默认答案。个体适用性要结合诊断、肾肝功能、完整药单、既往反应和目标市场现行说明书，由负责团队判断。", "en": "Genetic screening is not the site's default answer for choosing this medicine. Individual suitability requires diagnosis, renal and hepatic function, the complete medicine list, prior response and the current target-market label, reviewed by the treating team." } ], "source": { "id": "src_527bcad202bf135e", "label": "DailyMed（NLM）：SYNJARDY XR 当前美国公开标签（12.1 Mechanism of Action 与产品结构）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8006ba29-ee3a-f852-a9bb-c8ec9b41cf66", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "SYNJARDY XR", "generic": "恩格列净/盐酸二甲双胍缓释片", "dosageFormClass": "恩格列净/盐酸二甲双胍薄膜衣缓释口服片：5 mg/1,000 mg、10 mg/1,000 mg、12.5 mg/1,000 mg、25 mg/1,000 mg；美国标签要求整片吞服，不得掰开、压碎、溶解或咀嚼" }, "labelSource": { "id": "src_527bcad202bf135e", "label": "DailyMed（NLM）：SYNJARDY XR 当前美国公开品牌标签、四种展示包装与 Medication Guide（SPL v18；2026-08-21 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8006ba29-ee3a-f852-a9bb-c8ec9b41cf66", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "productRoutes": [ { "source": { "id": "src_527bcad202bf135e", "label": "DailyMed（NLM）：SYNJARDY XR 当前美国公开品牌标签、四种展示包装与 Medication Guide（SPL v18；2026-08-21 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8006ba29-ee3a-f852-a9bb-c8ec9b41cf66", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-30", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-30", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "SYNJARDY XR 一片同时含恩格列净和盐酸二甲双胍缓释成分。包装上的两个 mg 数字分别属于两种成分，不是相加后的单一强度，也不能与 JARDIANCE、GLUCOPHAGE、SYNJARDY 普通片、XIGDUO XR 或其他复方自行拼接。当前美国标签列四种强度，并要求缓释片整片吞服，不得掰开、压碎、溶解或咀嚼。网页帮助认清准确产品、成分、每片标示量和官方说明书，不生成个人片数、联用、换药、补服或停药方案。", "history": "FDA/NLM 当前标签记录 SYNJARDY XR 的美国初始批准年份为 2015，NDA 208658 的营销记录自 2016-12-10 开始；当前 SPL v18 于 2026-08-21 发布。美国 SYNJARDY XR 缓释片和欧盟 Synjardy 普通片属于不同市场、释放形式与文件，不能只凭共同成分或品牌词根合并。", "sourceDocuments": [ { "id": "src_527bcad202bf135e", "label": "DailyMed（NLM）：SYNJARDY XR 当前美国公开品牌标签、四种展示包装与 Medication Guide（SPL v18；2026-08-21 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8006ba29-ee3a-f852-a9bb-c8ec9b41cf66", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" } ], "applicationNumber": "FDA NDA 208658（SYNJARDY XR；恩格列净/盐酸二甲双胍缓释片）", "approvalTimeline": [ { "date": "2016-12-10", "title": { "zh": "美国 SYNJARDY XR NDA 208658 营销记录起始", "en": "U.S. SYNJARDY XR NDA 208658 marketing record began" }, "detail": { "zh": "当前 DailyMed 产品数据把 SYNJARDY XR、NDA 208658 和 2016-12-10 营销起始记录相连；标签同时列美国初始批准年份为 2015。该节点只建立美国产品史。", "en": "Current DailyMed product data link SYNJARDY XR, NDA 208658 and a 10 Dec 2016 marketing-start record; the label also lists 2015 as the initial U.S. approval year. This establishes U.S. product history only." }, "source": { "id": "src_527bcad202bf135e", "label": "DailyMed（NLM）：SYNJARDY XR 当前美国公开标签（NDA 208658 与产品记录）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8006ba29-ee3a-f852-a9bb-c8ec9b41cf66", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" } }, { "date": "2026-08-21", "title": { "zh": "当前 DailyMed SPL v18 发布", "en": "Current DailyMed SPL v18 published" }, "detail": { "zh": "该版本于 2026-08-11 更新、2026-08-21 发布，并在 2026-08 修订乳酸性酸中毒黑框警示。本页说明书阅读、准确包装、整片吞服及共同成分核对均以这一当前标签为主要来源。", "en": "This version was updated 11 Aug and published 21 Aug 2026, with the lactic-acidosis boxed warning revised in Aug 2026. This page's label reading, exact packages, whole-tablet rule and shared-ingredient review use that current label as the primary source." }, "source": { "id": "src_527bcad202bf135e", "label": "DailyMed（NLM）：SYNJARDY XR 当前美国公开品牌标签（SPL v18；2026-08-21 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8006ba29-ee3a-f852-a9bb-c8ec9b41cf66", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "当前公开品牌标签与四种准确展示包装已建立", "en": "Current public brand label and four exact displayed packages established" }, "detail": { "zh": "逐一记录四种每片双成分强度、NDC、瓶装数量、颜色、形状、刻印和官方标签面板；不表示具体渠道库存、购买资格、真伪或个人片数。", "en": "Records both per-tablet ingredient amounts, NDC, bottle count, colour, shape, imprint and official label panel for four displayed products. It does not establish channel stock, purchasing eligibility, authenticity or an individual tablet count." } }, { "market": { "zh": "欧盟", "en": "European Union" }, "status": { "zh": "当前 Synjardy 普通片产品资料已建立为分市场核对入口", "en": "Current Synjardy immediate-release product information established as a separate-market check" }, "detail": { "zh": "EMA 当前资料列恩格列净 5/12.5 mg 与二甲双胍 850/1,000 mg 的普通片组合。它不是美国 SYNJARDY XR 的缓释片规格或替换表。", "en": "Current EMA material lists immediate-release combinations of empagliflozin 5/12.5 mg with metformin 850/1,000 mg. It is not a strength or substitution table for U.S. SYNJARDY XR extended-release tablets." } }, { "market": { "zh": "中国大陆、日本及其他市场", "en": "Mainland China, Japan and other markets" }, "status": { "zh": "待逐项建立现行监管产品记录", "en": "Current regulatory product records not established" }, "detail": { "zh": "不从美国或欧盟商品名、共同成分、NDA/许可或包装推定当地批准、持有人、规格、供应、原研/参比关系或可替代性。", "en": "No local approval, holder, strength, supply, originator/reference relationship or interchangeability is inferred from a U.S. or EU trade name, shared ingredients, NDA/authorisation or pack." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "10 mg/1,000 mg 是 1,010 mg，还是一天两个时间？", "en": "Does 10 mg/1,000 mg mean 1,010 mg, or two times of day?" }, "answer": { "zh": "都不是。它表示一片分别含恩格列净 10 mg 和盐酸二甲双胍 1,000 mg。两个数字属于两种成分，不能相加后与其他药比较，也不能推导个人频次或片数。", "en": "Neither. One tablet contains 10 mg empagliflozin and 1,000 mg metformin HCl. The two numbers belong to two ingredients and cannot be added for comparison with another medicine or used to derive an individual's frequency or tablet count." } }, { "question": { "zh": "药片太大，可以掰开、压碎、溶解或嚼碎吗？", "en": "Can a large tablet be split, crushed, dissolved or chewed?" }, "answer": { "zh": "当前美国标签要求整片吞服，并明确不得掰开、压碎、溶解或咀嚼。吞咽困难时请带准确药盒联系开方团队或药师讨论可行产品，不要自行破坏缓释结构。", "en": "The current U.S. label requires swallowing whole and explicitly says not to split, crush, dissolve or chew. If swallowing is difficult, take the exact pack to the prescriber or pharmacist to discuss an appropriate product rather than damaging the extended-release design." } }, { "question": { "zh": "已经吃 SYNJARDY XR，还能再吃 JARDIANCE 或二甲双胍吗？", "en": "Can JARDIANCE or metformin be added when SYNJARDY XR is already used?" }, "answer": { "zh": "网页不能决定联用。SYNJARDY XR 已含恩格列净和盐酸二甲双胍；药单中再出现共同成分必须优先核对，不能自行叠加、轮换或停掉其中一盒。", "en": "A webpage cannot decide combination use. SYNJARDY XR already contains empagliflozin and metformin HCl. Another shared ingredient on the medicine list requires priority review, not self-combination, alternation or stopping a pack." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "dosage-forms-are-part-of-medicine-identity", "how-to-read-a-drug-label", "generic-drugs-and-bioequivalence" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/synjardy-xr/", "en": "https://origindrug.com/en/drugs/synjardy-xr/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "zoloft", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-23", "status": "published_traceable_archive" }, "names": { "brand": "Zoloft", "generic": "舍曲林", "aliases": [ "sertraline" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "精神健康", "sourceArchiveMarket": "美国 FDA 历史标签档案；另有 DailyMed 2023 修订的具体 25 mg、30 片瓶装面板（不推定当前可得性）", "dosageFormClass": "片剂及口服溶液（FDA 2021 标签档案所列）；本页精确包装面板仅为 25 mg 片剂", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "1991（FDA 标签所列美国初始批准）", "archiveSponsorText": "FDA 监管档案；DailyMed 品牌标签面板" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-zoloft-sertraline-tablet-25mg-30-count-bottle-ndc-58151-574-93", "marketCode": "US", "labelVersion": { "zh": "DailyMed 公开标签（2023 修订；页面于 2026-08-23 复核）", "en": "DailyMed public label (revised 2023; source checked 23 Aug 2026)" }, "dosageForm": { "zh": "ZOLOFT 舍曲林盐酸盐薄膜衣口服片", "en": "ZOLOFT sertraline hydrochloride film-coated oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 58151-574-93", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片舍曲林 25 mg；30 片瓶装", "en": "Sertraline 25 mg per tablet; 30-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=image-02.jpg&setid=fda754f6-d0f3-4dce-a17a-927d64f912f7&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "舍曲林", "en": "sertraline" }, "value": 25, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、加减、减量或换药规则", "en": "labelled amount per tablet; not an individual's tablet count, adjustment, tapering or switching rule" } }, { "ingredient": { "zh": "盐酸舍曲林", "en": "sertraline hydrochloride" }, "value": 28, "unit": "mg", "basisCode": "salt_equivalent_per_tablet", "basisLabel": { "zh": "标签所列盐的量，等同于每片舍曲林 25 mg；不是额外剂量", "en": "labelled salt amount equivalent to sertraline 25 mg per tablet; not an additional dose" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "30 片瓶装", "en": "30-tablet bottle" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-23", "currentLabelDisplayed": false, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 30, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "瓶装标签主展示面；片剂实际颜色须按药盒与现行标签复核", "en": "bottle-label display panel; actual tablet colour must be checked against the pack and current label" }, "shape": { "zh": "薄膜衣口服片", "en": "film-coated oral tablet" }, "imprint": null, "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_52108ac0b22727bc", "label": "DailyMed（NLM）：ZOLOFT 舍曲林盐酸盐 25 mg、30 片瓶装美国公开标签面板（Viatris；2023 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=fda754f6-d0f3-4dce-a17a-927d64f912f7", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-zoloft-sertraline-tablet-25mg-30-count-bottle-ndc-58151-574-93", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=image-02.jpg&setid=fda754f6-d0f3-4dce-a17a-927d64f912f7&type=img", "alt": "ZOLOFT 25 mg 舍曲林片在美国 DailyMed 公开标签中的瓶装标签图", "archiveMarket": "美国", "labelVersion": "DailyMed 公开标签（2023 修订）", "presentation": "ZOLOFT 25 mg、30 片瓶装标签图（DailyMed 公开标签所列）。", "notice": "此为美国 DailyMed 公开标签中明确对应 ZOLOFT 25 mg、30 片瓶装的标签图，只帮助核对品牌、通用名、标示强度、片剂和来源；不用于鉴定真伪，也不证明其他强度、口服浓缩液、其他市场标签、当前包装、原研身份、目标市场批准或可售资格。", "source": { "id": "src_52108ac0b22727bc", "label": "DailyMed（NLM）：ZOLOFT 公开标签（2023 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=fda754f6-d0f3-4dce-a17a-927d64f912f7", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "ZOLOFT 说明书放大阅读：片剂与口服浓缩液不能只按毫克或毫升互换", "en": "ZOLOFT label reading: tablets and oral concentrate are not exchanged by milligrams or millilitres alone" }, "summary": { "zh": "本模块以 FDA 2021 美国标签为阅读入口，帮助区分 ZOLOFT 的片剂、口服浓缩液、标示强度和完整药单；它不提供个人起始、加减、漏用或转换方案。", "en": "This module uses the 2021 U.S. FDA label as a reading entry point. It helps distinguish ZOLOFT tablets, oral concentrate, labelled strength and the complete medicine list; it does not provide an individual start, adjustment, missed-use or switching plan." }, "checks": [ { "zh": "先把 ZOLOFT、舍曲林、片剂或口服浓缩液、每单位标示强度/浓度和目标市场一起核对。同一通用名不使片数、毫升数、滴管刻度或其他市场的产品可以自行换算。", "en": "Check ZOLOFT, sertraline, tablet or oral concentrate, labelled strength/concentration per unit and target market together. A shared generic name does not make tablet count, millilitres, dropper markings or another-market products self-convertible." }, { "zh": "FDA 标签对口服浓缩液的稀释有产品特定要求；不要把它当作可直接吞服的普通液体，或套用另一种糖浆、滴剂或口服液的用法。准确产品的现行标签和药师指导优先。", "en": "The FDA label has product-specific dilution requirements for the oral concentrate. Do not treat it as an ordinary ready-to-swallow liquid or apply instructions from another syrup, drop or oral liquid. The current label and pharmacist guidance for the exact product take priority." }, { "zh": "标签涉及与 MAOI、其他影响血清素的药物及多种联用产品时的警示。止痛、咳嗽感冒、偏头痛、助眠、草本或其他精神科药物都应列入完整药单，不要仅凭名称不同就自行合并或替换。", "en": "The label has warnings involving MAOIs, other serotonin-affecting medicines and multiple co-medications. Pain, cough/cold, migraine, sleep, herbal and other psychiatric products all belong on the complete medicine list; do not self-combine or replace merely because names differ." }, { "zh": "开始、减量、停用和改用另一种精神科药物需要由开方团队安排。出现明显激越、意识改变、严重不适或自伤风险等急性情况时，应使用当地紧急与医疗支持渠道，而不是从网页自行改药。", "en": "Starting, tapering, stopping and changing to another psychiatric medicine need a plan from the prescribing team. With marked agitation, altered awareness, severe symptoms or acute self-harm risk, use local urgent and medical-support pathways rather than self-changing treatment from a webpage." } ], "source": { "id": "src_f145e4b96222c90d", "label": "FDA：ZOLOFT 2021 美国处方信息（NDA 019839 / 020990）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/019839s100%2C020990s057lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "舍曲林怎样起作用：它主要抑制血清素再摄取", "en": "How sertraline works: it primarily inhibits serotonin reuptake" }, "summary": { "zh": "FDA 标签将舍曲林描述为血清素再摄取抑制剂。这个机制帮助理解为何其他影响血清素的产品与停用/转换问题需要额外核对；它不预测个人情绪变化、适用性、剂量或起效时间。", "en": "The FDA label describes sertraline as a serotonin reuptake inhibitor. This helps explain why other serotonin-affecting products and discontinuation/switch questions need extra review; it does not predict an individual’s mood change, suitability, dose or onset time." }, "checks": [ { "zh": "共同影响血清素不使不同抗抑郁药、偏头痛药、止痛药、咳嗽感冒药或草本产品可自行叠加、轮换或换算。完整药单是专业人员判断的起点。", "en": "A shared effect on serotonin does not make antidepressants, migraine medicines, pain medicines, cough/cold products or herbs self-combinable, interchangeable or convertible. A complete medicine list is the starting point for professional review." }, { "zh": "机制不能给出个人开始、加量、减量或停用的时间表。任何变化都要依据准确产品的现行标签、开方原因和专业团队的安排。", "en": "Mechanism cannot provide an individual timetable for starting, increasing, tapering or stopping. Any change needs the current label for the exact product, the prescribing reason and a professional team’s plan." }, { "zh": "情绪、睡眠、焦虑、身体不适或急性精神健康风险都不能仅从机制推断处理。需要时应使用当地医疗、心理和紧急支持渠道。", "en": "Mood, sleep, anxiety, physical symptoms and acute mental-health risk cannot be managed by inferring from mechanism alone. Use local medical, mental-health and urgent-support pathways when needed." } ], "source": { "id": "src_f145e4b96222c90d", "label": "FDA：ZOLOFT 2021 美国处方信息（临床药理）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/019839s100%2C020990s057lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "Zoloft", "generic": "舍曲林", "dosageFormClass": "片剂及口服溶液（FDA 2021 标签档案所列）；本页精确包装面板仅为 25 mg 片剂" }, "labelSource": { "id": "src_52108ac0b22727bc", "label": "DailyMed（NLM）：ZOLOFT 舍曲林盐酸盐 25 mg、30 片瓶装美国公开标签面板（Viatris；2023 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=fda754f6-d0f3-4dce-a17a-927d64f912f7", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "productRoutes": [ { "source": { "id": "src_52108ac0b22727bc", "label": "DailyMed（NLM）：ZOLOFT 舍曲林盐酸盐 25 mg、30 片瓶装美国公开标签面板（Viatris；2023 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=fda754f6-d0f3-4dce-a17a-927d64f912f7", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_f145e4b96222c90d", "label": "FDA：ZOLOFT 2021 美国标签档案（NDA 019839 / 020990）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/019839s100%2C020990s057lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "FDA 的 ZOLOFT（sertraline hydrochloride）2021 标签档案列示片剂及口服溶液，并列出美国初始批准年份为 1991。本页另建立 DailyMed 2023 修订标签中一个准确的 25 mg、30 片瓶装面板，帮助核对品牌、通用名、每片标示量、NDC 与包装；不据此推定其他强度、口服浓缩液、现行标签、其他市场批准、原研关系、供应、价格或可售资格。", "history": "同一通用名下的片剂与口服溶液属于不同剂型呈现，不能只按名称、毫克数或照片建立完整产品等同性。图中 25 mg 与 NDC 58151-574-93 只对应一个美国 30 片瓶装标签面板；任何目标市场的规格、标签、适应症、安全性与市场状态均须以现行官方文件和专业判断核验。", "sourceDocuments": [ { "id": "src_52108ac0b22727bc", "label": "DailyMed（NLM）：ZOLOFT 舍曲林盐酸盐 25 mg、30 片瓶装美国公开标签面板（Viatris；2023 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=fda754f6-d0f3-4dce-a17a-927d64f912f7", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_f145e4b96222c90d", "label": "FDA：ZOLOFT 2021 美国标签档案（NDA 019839 / 020990）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/019839s100%2C020990s057lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_5ed30b676fbb9773", "label": "FDA Drugs@FDA 官方检索入口", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_lookup_entry", "documentKind": "regulatory_lookup", "market": "US", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } ], "applicationNumber": "NDA 019839 / 020990", "approvalTimeline": [ { "date": "1991", "title": { "zh": "FDA 标签所列美国初始批准年份", "en": "Initial U.S. approval year listed in the FDA label" }, "detail": { "zh": "本页链接的 FDA 标签档案列示 Initial U.S. Approval: 1991。该历史定位不等同于当前批准、可得性、持有人或其他市场状态。", "en": "The FDA label archive linked here lists Initial U.S. Approval: 1991. This historical locator is not a conclusion about current approval, availability, holder or another market." }, "source": { "id": "src_f145e4b96222c90d", "label": "FDA: ZOLOFT label archive", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/019839s100%2C020990s057lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, { "date": "2021", "title": { "zh": "FDA 标签档案版本", "en": "FDA label archive version" }, "detail": { "zh": "本页链接 2021 的 FDA 标签档案作为可复核阅读入口。现行标签、规格、适应症和安全信息必须另行以目标市场当前文件核对。", "en": "This page links the 2021 FDA label archive as a traceable reading entry point. Current labeling, strength, indication and safety information require separate verification against the target market’s current document." }, "source": { "id": "src_f145e4b96222c90d", "label": "FDA: ZOLOFT label archive", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/019839s100%2C020990s057lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "已链接公开标签档案", "en": "Public label archive linked" }, "detail": { "zh": "仅对应本页所列 FDA 文件。", "en": "Only the FDA document listed on this page is linked." } }, { "market": { "zh": "中国大陆、欧盟、日本", "en": "Mainland China, EU, Japan" }, "status": { "zh": "待逐项建立市场记录", "en": "Market record not established" }, "detail": { "zh": "不从美国标签档案推定当地批准、持有人、规格、供应或可售资格。", "en": "No local approval, holder, strength, supply or sale-eligibility conclusion is inferred from the U.S. label archive." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "标签档案能代表现在的产品信息吗？", "en": "Does a label archive represent current product information?" }, "answer": { "zh": "不能自动代表。档案用于定位来源；需要以目标市场的现行官方标签逐项复核。", "en": "Not automatically. The archive locates a source; each point needs verification against the target market’s current official label." } }, { "question": { "zh": "为什么这里不展示价格或原研/仿制结论？", "en": "Why are price and originator/generic conclusions not shown?" }, "answer": { "zh": "这些结论需要产品、剂型、规格、包装、市场、日期和原始记录分别齐全并经人工审核；单一标签文件不足以支持。", "en": "Those conclusions require separately complete and human-reviewed product, dosage-form, strength, pack, market, date and primary-record fields; one label file is insufficient." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "how-to-read-a-drug-label", "regulatory-sources-first" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/zoloft/", "en": "https://origindrug.com/en/drugs/zoloft/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "prozac", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-24", "status": "published_traceable_archive" }, "names": { "brand": "Prozac", "generic": "氟西汀", "aliases": [ "fluoxetine" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "精神健康", "sourceArchiveMarket": "美国 DailyMed SPL v59 公开标签；已逐一核验 20 mg、100 粒瓶装及其同标签官方包装面板（不推定实际可得性）", "dosageFormClass": "口服胶囊：10 mg、20 mg、40 mg（DailyMed 2026-01 标签所列）；本页精确包装面板仅为 20 mg 胶囊", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "1987（DailyMed 公开标签所列美国初始批准）", "archiveSponsorText": "Dista Products Company / DailyMed 公开监管标签档案" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [ "PROZAC Weekly", "fluoxetine delayed-release capsule", "氟西汀延迟释放胶囊" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-prozac-fluoxetine-capsule-20mg-100-count-bottle-ndc-0777-3105-02", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v59（2026-01 发布；包装图于 2026-08-24 复核）", "en": "DailyMed SPL v59 (published Jan 2026; package image checked 24 Aug 2026)" }, "dosageForm": { "zh": "PROZAC 氟西汀盐酸盐口服胶囊", "en": "PROZAC fluoxetine hydrochloride oral capsule" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 0777-3105-02", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_capsule", "primaryDisplay": { "zh": "每粒氟西汀 20 mg；100 粒瓶装", "en": "Fluoxetine 20 mg per capsule; 100-capsule bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=prozac-20mg-container-100-001-01.jpg&setid=c88f33ed-6dfb-4c5e-bc01-d8e36dd97299&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "氟西汀", "en": "fluoxetine" }, "value": 20, "unit": "mg", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒标签标示量；不是个人粒数、加减、减量、联用或换药规则", "en": "labelled amount per capsule; not an individual's capsule count, adjustment, tapering, combination or switching rule" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "100 粒瓶装", "en": "100-capsule bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-24", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "physicalClues": { "color": { "zh": "胶囊帽不透明绿色、胶囊体不透明黄色（标签文字）", "en": "opaque green cap and opaque yellow body (label text)" }, "shape": { "zh": "硬明胶口服胶囊", "en": "hard-gelatin oral capsule" }, "imprint": { "zh": "DISTA 3105（标签文字）", "en": "DISTA 3105 (label text)" }, "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_ac07b7babdcbb75e", "label": "DailyMed（NLM）：PROZAC 氟西汀 20 mg、100 粒瓶装美国公开标签面板（Dista Products Company，2026-01 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c88f33ed-6dfb-4c5e-bc01-d8e36dd97299", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-prozac-fluoxetine-capsule-20mg-100-count-bottle-ndc-0777-3105-02", "status": "exact_public_label_package_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=prozac-20mg-container-100-001-01.jpg&setid=c88f33ed-6dfb-4c5e-bc01-d8e36dd97299&type=img", "alt": "PROZAC 20 mg 氟西汀盐酸盐口服胶囊在美国 DailyMed 公开标签中的 Dista 100 粒包装面板", "archiveMarket": "美国", "labelVersion": "DailyMed 公开标签（Dista Products Company，2026-01 更新）", "presentation": "PROZAC 20 mg、100 粒口服胶囊包装面板（DailyMed 公开标签所列；Dista 包装面板）。", "notice": "此图只对应美国 DailyMed 标签中的 PROZAC、氟西汀 20 mg、NDC 0777-3105-02 与 100 粒瓶装。它只帮助核对品牌、通用名、每粒标示量、胶囊、包装数量与来源；不用于鉴定真伪，也不证明 10 mg、40 mg、延迟释放胶囊、其他包装、其他市场、当前可得性、原研身份、可替代性或任何个人的粒数、联用、减量、停用或换药方案。", "source": { "id": "src_ac07b7babdcbb75e", "label": "DailyMed（NLM）：PROZAC 氟西汀 20 mg、100 粒瓶装美国公开标签面板（Dista Products Company，2026-01 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c88f33ed-6dfb-4c5e-bc01-d8e36dd97299", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "PROZAC 说明书放大阅读：10、20、40 mg 是胶囊标示强度，不是自行调整方案", "en": "PROZAC label reading: 10, 20 and 40 mg identify capsule strengths, not a self-adjustment plan" }, "summary": { "zh": "本模块以 FDA 2021 美国标签与 DailyMed 公开标签为阅读入口，帮助核对 PROZAC、fluoxetine、口服胶囊和包装上的 mg；不把包装文字转换成个人开始、联用、换药、减量或停药方案。", "en": "This module uses the 2021 FDA U.S. label and the public DailyMed label as reading entry points. It helps check PROZAC, fluoxetine, oral capsules and the mg printed on a package; it does not turn package text into an individual start, combination, switch, reduction or stop plan." }, "checks": [ { "zh": "FDA 2021 标签列出 10、20、40 mg 的口服胶囊。mg 首先是该胶囊的标示强度；它不能单独回答今天该服多少、是否应加减，或能否用另一种规格拼凑。应以实际处方、实际包装和现行标签为准。", "en": "The 2021 FDA label lists 10, 20 and 40 mg oral capsules. Mg first identifies the stated strength of that capsule; it cannot by itself answer how much to take today, whether to adjust, or whether another strength may be combined. Use the actual prescription, package and current label." }, { "zh": "“口服胶囊”不等同于所有写有 fluoxetine 的产品。历史标签还出现过延迟释放胶囊；名称相同或相近、照片相似，都不足以确认释放方式、规格或可否替代。", "en": "“Oral capsule” does not mean every product labelled fluoxetine is the same. Historical labels also include a delayed-release capsule; a matching name or similar photograph does not confirm release type, strength or substitutability." }, { "zh": "FDA 标签把与其他药物同时使用、尤其转换或联合时的相互作用和血清素综合征风险列为需要核对的事项。请把全部处方药、非处方药、补充剂和近期变动交给药师或开方团队；网页不能给出个人能否同用或怎样转换的结论。", "en": "The FDA label identifies interactions and serotonin-syndrome risk with other medicines, especially around changes or combinations, as items needing review. Give the pharmacist or prescribing team the complete list of prescription medicines, non-prescription products, supplements and recent changes; a webpage cannot decide whether an individual combination or switch is appropriate." }, { "zh": "标签含有临床恶化和自杀风险等重要警示。出现突然或令人担忧的情绪、行为或安全变化时，应及时联系开方团队；如有紧急安全风险，应使用当地紧急医疗或危机支持。不要仅因药盒、剩余药量或网络信息自行骤停或改用其他抗抑郁药。", "en": "The label includes important warnings about clinical worsening and suicide risk. Seek timely contact with the prescribing team for sudden or concerning mood, behaviour or safety changes; use local emergency or crisis support for an urgent safety risk. Do not abruptly stop or substitute another antidepressant solely because of a package, remaining capsules or online information." } ], "source": { "id": "src_6759db7705c44b63", "label": "FDA：PROZAC 2021 美国标签（NDA 018936；标签阅读与安全警示）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/018936s111lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "PROZAC 机制阅读：SSRI 是分类线索，不是自行联用或换药规则", "en": "PROZAC mechanism reading: SSRI is a classification clue, not a self-combination or switching rule" }, "summary": { "zh": "FDA 2021 标签将 PROZAC 描述为选择性血清素再摄取抑制剂（SSRI），并说明其确切机制尚未完全确定、推测与抑制中枢神经元对血清素的摄取有关。机制文字帮助理解标签，不能替代个体评估。", "en": "The 2021 FDA label describes PROZAC as a selective serotonin reuptake inhibitor (SSRI), and states that its exact mechanism is not fully known but is presumed to relate to inhibition of CNS neuronal serotonin uptake. Mechanism language helps read a label; it cannot replace individual assessment." }, "checks": [ { "zh": "“影响血清素摄取”是药理层面的描述，并不能从中推导某个人会有什么症状、何时见效，或应选哪一种抗抑郁药。", "en": "“Affects serotonin uptake” is a pharmacology description; it cannot predict one person's symptoms, timing of effects or which antidepressant should be chosen." }, { "zh": "同属 SSRI、同样涉及血清素，或在包装上写有不同名称，都不代表可以自行叠加、交替或替换。FDA 标签提示应核对其他药物及相互作用；变更前应由专业人员查看完整药单和实际产品。", "en": "Sharing the SSRI class, serotonin involvement or a different package name does not make products suitable for self-combination, alternation or substitution. The FDA label calls for review of other medicines and interactions; a professional should review the complete medication list and actual products before a change." }, { "zh": "机制说明也不能用来设计个人减停计划。若出现令人担忧的情绪、行为或安全变化，应联系开方团队；紧急安全风险应使用当地紧急医疗或危机支持。", "en": "Mechanism information also cannot be used to design an individual reduction or stopping plan. Contact the prescribing team for concerning mood, behaviour or safety changes; use local emergency or crisis support for an urgent safety risk." } ], "source": { "id": "src_6759db7705c44b63", "label": "FDA：PROZAC 2021 美国标签（NDA 018936；12.1 机制与相互作用/警示）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/018936s111lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "Prozac", "generic": "氟西汀", "dosageFormClass": "口服胶囊：10 mg、20 mg、40 mg（DailyMed 2026-01 标签所列）；本页精确包装面板仅为 20 mg 胶囊" }, "labelSource": { "id": "src_6759db7705c44b63", "label": "FDA：PROZAC 2021 美国标签档案（NDA 018936）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/018936s111lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "productRoutes": [ { "source": { "id": "src_6759db7705c44b63", "label": "FDA：PROZAC 2021 美国标签档案（NDA 018936）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/018936s111lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_ac07b7babdcbb75e", "label": "DailyMed（NLM）：PROZAC 氟西汀 20 mg、100 粒瓶装美国公开标签面板（Dista Products Company，2026-01 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c88f33ed-6dfb-4c5e-bc01-d8e36dd97299", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "DailyMed 的 PROZAC（fluoxetine hydrochloride）2026-01 美国公开标签列示 10 mg、20 mg、40 mg 口服胶囊，并标示美国初始批准年份为 1987。本页仅展示同一公开标签中已逐一核验的 20 mg、100 粒瓶装面板，帮助核对品牌、通用名、每粒标示量、NDC 与包装；不据此推定 10 mg、40 mg、延迟释放胶囊、其他包装、其他市场、原研关系、供应、价格或可售资格。", "history": "已核验的 20 mg 与 NDC 0777-3105-02 只对应一个美国 100 粒口服胶囊标签记录及同标签包装面板。该图不确认 10 mg、40 mg、历史延迟释放胶囊、其他包装、其他市场、当前包装或任何产品真实性；“氟西汀”或“PROZAC”名称本身也不足以建立完整产品身份。", "sourceDocuments": [ { "id": "src_ac07b7babdcbb75e", "label": "DailyMed（NLM）：PROZAC 氟西汀 20 mg、100 粒瓶装美国公开标签面板（Dista Products Company，2026-01 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c88f33ed-6dfb-4c5e-bc01-d8e36dd97299", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_6759db7705c44b63", "label": "FDA：PROZAC 2021 美国标签档案（NDA 018936）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/018936s111lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_5ed30b676fbb9773", "label": "FDA Drugs@FDA 官方检索入口", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_lookup_entry", "documentKind": "regulatory_lookup", "market": "US", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } ], "applicationNumber": "NDA 018936", "approvalTimeline": [ { "date": "1987", "title": { "zh": "FDA 标签所列美国初始批准年份", "en": "Initial U.S. approval year listed in the FDA label" }, "detail": { "zh": "本页链接的 FDA 标签档案列示 Initial U.S. Approval: 1987。该历史定位不等同于当前批准、可得性、持有人或其他市场状态。", "en": "The FDA label archive linked here lists Initial U.S. Approval: 1987. This historical locator is not a conclusion about current approval, availability, holder or another market." }, "source": { "id": "src_68686c9a07b9a87e", "label": "DailyMed: PROZAC current U.S. public label", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=c88f33ed-6dfb-4c5e-bc01-d8e36dd97299", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, { "date": "DailyMed SPL v59, published 2026-01-14", "title": { "zh": "FDA 标签档案版本", "en": "FDA label archive version" }, "detail": { "zh": "本页链接 DailyMed SPL v59, published 2026-01-14 的 FDA 标签档案作为可复核阅读入口。现行标签、规格、适应症和安全信息必须另行以目标市场当前文件核对。", "en": "This page links the DailyMed SPL v59, published 2026-01-14 FDA label archive as a traceable reading entry point. Current labeling, strength, indication and safety information require separate verification against the target market’s current document." }, "source": { "id": "src_68686c9a07b9a87e", "label": "DailyMed: PROZAC current U.S. public label", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=c88f33ed-6dfb-4c5e-bc01-d8e36dd97299", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "已链接公开标签档案", "en": "Public label archive linked" }, "detail": { "zh": "仅对应本页所列 FDA 文件。", "en": "Only the FDA document listed on this page is linked." } }, { "market": { "zh": "中国大陆、欧盟、日本", "en": "Mainland China, EU, Japan" }, "status": { "zh": "待逐项建立市场记录", "en": "Market record not established" }, "detail": { "zh": "不从美国标签档案推定当地批准、持有人、规格、供应或可售资格。", "en": "No local approval, holder, strength, supply or sale-eligibility conclusion is inferred from the U.S. label archive." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "标签档案能代表现在的产品信息吗？", "en": "Does a label archive represent current product information?" }, "answer": { "zh": "不能自动代表。档案用于定位来源；需要以目标市场的现行官方标签逐项复核。", "en": "Not automatically. The archive locates a source; each point needs verification against the target market’s current official label." } }, { "question": { "zh": "为什么这里不展示价格或原研/仿制结论？", "en": "Why are price and originator/generic conclusions not shown?" }, "answer": { "zh": "这些结论需要产品、剂型、规格、包装、市场、日期和原始记录分别齐全并经人工审核；单一标签文件不足以支持。", "en": "Those conclusions require separately complete and human-reviewed product, dosage-form, strength, pack, market, date and primary-record fields; one label file is insufficient." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "how-to-read-a-drug-label", "regulatory-sources-first" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/prozac/", "en": "https://origindrug.com/en/drugs/prozac/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "paxil", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-23", "status": "published_traceable_archive" }, "names": { "brand": "Paxil", "generic": "帕罗西汀", "aliases": [ "paroxetine" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "精神健康", "sourceArchiveMarket": "美国公开监管标签档案", "dosageFormClass": "口服片剂（10、20、30、40 mg）及口服混悬剂（10 mg/5 mL；标签注明当时未上市）", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "1992（FDA 标签所列美国初始批准）", "archiveSponsorText": "FDA / DailyMed 公开监管标签档案" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-paxil-paroxetine-tablet-20mg-30-count-bottle-ndc-54868-2976-2-historical-2012", "marketCode": "US", "labelVersion": { "zh": "DailyMed 历史公开标签（2012-01-05；非现行包装或供应结论）", "en": "DailyMed historical public label (5 Jan 2012; not a current-package or availability finding)" }, "dosageForm": { "zh": "PAXIL 帕罗西汀盐酸盐薄膜衣口服片", "en": "PAXIL paroxetine hydrochloride film-coated oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 54868-2976-2", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片帕罗西汀 20 mg；30 片瓶装（美国历史标签）", "en": "Paroxetine 20 mg per tablet; 30-tablet bottle (U.S. historical label)" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=2976.jpg&setid=40226242-da82-4dd7-bca2-eebb14501264&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "帕罗西汀", "en": "paroxetine" }, "value": 20, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片历史标签标示量；不是个人片数、掰开、减量、联用或换药规则", "en": "historical labelled amount per tablet; not an individual's tablet count, splitting, tapering, combination or switching rule" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "30 片瓶装", "en": "30-tablet bottle" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-23", "currentLabelDisplayed": false, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 30, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "粉红色；历史标签所列", "en": "pink; listed in the historical label" }, "shape": { "zh": "改良椭圆形薄膜衣片；刻字 PAXIL / 20；有刻痕不是自行掰开指示", "en": "modified oval film-coated tablet; imprint PAXIL / 20; a score line is not self-splitting instruction" }, "imprint": null, "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_e7eb34ccc3076418", "label": "DailyMed（NLM）：PAXIL 帕罗西汀 20 mg、30 片瓶装美国历史公开标签身份（GlaxoSmithKline；2012-01-05）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=40226242-da82-4dd7-bca2-eebb14501264", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-paxil-paroxetine-tablet-20mg-60-count-bottle-ndc-54868-2976-3-historical-2012", "marketCode": "US", "labelVersion": { "zh": "DailyMed 历史公开标签（2012-01-05；非现行包装或供应结论）", "en": "DailyMed historical public label (5 Jan 2012; not a current-package or availability finding)" }, "dosageForm": { "zh": "PAXIL 帕罗西汀盐酸盐薄膜衣口服片", "en": "PAXIL paroxetine hydrochloride film-coated oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 54868-2976-3", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片帕罗西汀 20 mg；60 片瓶装（美国历史标签）", "en": "Paroxetine 20 mg per tablet; 60-tablet bottle (U.S. historical label)" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "帕罗西汀", "en": "paroxetine" }, "value": 20, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片历史标签标示量；不是个人片数、掰开、减量、联用或换药规则", "en": "historical labelled amount per tablet; not an individual's tablet count, splitting, tapering, combination or switching rule" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "60 片瓶装", "en": "60-tablet bottle" }, "fill": null, "countPerPackage": 60, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-23", "currentLabelDisplayed": false, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 60, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "粉红色；历史标签所列", "en": "pink; listed in the historical label" }, "shape": { "zh": "改良椭圆形薄膜衣片；刻字 PAXIL / 20；有刻痕不是自行掰开指示", "en": "modified oval film-coated tablet; imprint PAXIL / 20; a score line is not self-splitting instruction" }, "imprint": null, "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_e7eb34ccc3076418", "label": "DailyMed（NLM）：PAXIL 帕罗西汀 20 mg、60 片瓶装美国历史公开标签身份（GlaxoSmithKline；2012-01-05）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=40226242-da82-4dd7-bca2-eebb14501264", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-paxil-paroxetine-tablet-30mg-30-count-bottle-ndc-54868-3526-0-historical-2012", "marketCode": "US", "labelVersion": { "zh": "DailyMed 历史公开标签（2012-01-05；非现行包装或供应结论）", "en": "DailyMed historical public label (5 Jan 2012; not a current-package or availability finding)" }, "dosageForm": { "zh": "PAXIL 帕罗西汀盐酸盐薄膜衣口服片", "en": "PAXIL paroxetine hydrochloride film-coated oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 54868-3526-0", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片帕罗西汀 30 mg；30 片瓶装（美国历史标签）", "en": "Paroxetine 30 mg per tablet; 30-tablet bottle (U.S. historical label)" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "帕罗西汀", "en": "paroxetine" }, "value": 30, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片历史标签标示量；不是个人片数、掰开、减量、联用或换药规则", "en": "historical labelled amount per tablet; not an individual's tablet count, splitting, tapering, combination or switching rule" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "30 片瓶装", "en": "30-tablet bottle" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-23", "currentLabelDisplayed": false, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 30, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "蓝色；历史标签所列", "en": "blue; listed in the historical label" }, "shape": { "zh": "改良椭圆形薄膜衣片；刻字 PAXIL / 30；有刻痕不是自行掰开指示", "en": "modified oval film-coated tablet; imprint PAXIL / 30; a score line is not self-splitting instruction" }, "imprint": null, "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_e7eb34ccc3076418", "label": "DailyMed（NLM）：PAXIL 帕罗西汀 30 mg、30 片瓶装美国历史公开标签身份（GlaxoSmithKline；2012-01-05）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=40226242-da82-4dd7-bca2-eebb14501264", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-paxil-paroxetine-tablet-30mg-60-count-bottle-ndc-54868-3526-1-historical-2012", "marketCode": "US", "labelVersion": { "zh": "DailyMed 历史公开标签（2012-01-05；非现行包装或供应结论）", "en": "DailyMed historical public label (5 Jan 2012; not a current-package or availability finding)" }, "dosageForm": { "zh": "PAXIL 帕罗西汀盐酸盐薄膜衣口服片", "en": "PAXIL paroxetine hydrochloride film-coated oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 54868-3526-1", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片帕罗西汀 30 mg；60 片瓶装（美国历史标签）", "en": "Paroxetine 30 mg per tablet; 60-tablet bottle (U.S. historical label)" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "帕罗西汀", "en": "paroxetine" }, "value": 30, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片历史标签标示量；不是个人片数、掰开、减量、联用或换药规则", "en": "historical labelled amount per tablet; not an individual's tablet count, splitting, tapering, combination or switching rule" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "60 片瓶装", "en": "60-tablet bottle" }, "fill": null, "countPerPackage": 60, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-23", "currentLabelDisplayed": false, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 60, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "蓝色；历史标签所列", "en": "blue; listed in the historical label" }, "shape": { "zh": "改良椭圆形薄膜衣片；刻字 PAXIL / 30；有刻痕不是自行掰开指示", "en": "modified oval film-coated tablet; imprint PAXIL / 30; a score line is not self-splitting instruction" }, "imprint": null, "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_e7eb34ccc3076418", "label": "DailyMed（NLM）：PAXIL 帕罗西汀 30 mg、60 片瓶装美国历史公开标签身份（GlaxoSmithKline；2012-01-05）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=40226242-da82-4dd7-bca2-eebb14501264", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": null, "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=2976.jpg&setid=40226242-da82-4dd7-bca2-eebb14501264&type=img", "alt": "PAXIL 20 mg 帕罗西汀片在美国 DailyMed 历史公开标签中的 GlaxoSmithKline 包装标签图", "archiveMarket": "美国", "labelVersion": "DailyMed 历史公开标签（GlaxoSmithKline，2012-01-05）", "presentation": "PAXIL 20 mg 口服片剂历史包装标签图（DailyMed 公开档案所列；GlaxoSmithKline 2012-01-05 文件）。", "notice": "此为美国 DailyMed 历史公开标签中与 PAXIL 20 mg 口服片剂对应的包装文字图，只帮助核对品牌、通用名、标示强度、剂型、历史标签版本和来源；不用于鉴定真伪，也不证明 10/30/40 mg、口服混悬剂、其他包装、其他市场标签、当前包装、原研身份、目标市场批准或可售资格。", "source": { "id": "src_e7eb34ccc3076418", "label": "DailyMed（NLM）：PAXIL 历史公开标签（GlaxoSmithKline，2012-01-05）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=40226242-da82-4dd7-bca2-eebb14501264", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "PAXIL / 帕罗西汀说明书放大阅读：mg、mg/5 mL 与“不要自行骤停”", "en": "PAXIL label reading: mg, mg/5 mL and why not to stop abruptly" }, "summary": { "zh": "本模块以 FDA 2024 与 DailyMed 的 PAXIL 公开标签为阅读入口，帮助核对片剂、口服混悬剂、标示强度与包装文字；它不把这些文字转换为个人开始、联用、换药、加减或停药方案。", "en": "This module uses the 2024 FDA and DailyMed PAXIL public labels as reading entry points. It helps check tablets, oral suspension, labelled strength and package wording; it does not turn them into an individual start, combination, switch, adjustment or stopping plan." }, "checks": [ { "zh": "FDA 2024 标签列出 10、20、30、40 mg 片剂；口服混悬剂为 10 mg/5 mL，且该标签注明当时未上市。mg 与 mg/5 mL 分别是片剂强度和液体浓度的标示方式；它们不能按片数或毫升数凭经验自行换算、替代或加减。", "en": "The 2024 FDA label lists 10, 20, 30 and 40 mg tablets, and an oral suspension of 10 mg/5 mL that the label states was not then marketed. Mg and mg/5 mL label tablet strength and liquid concentration respectively; they cannot be self-converted, substituted or adjusted by tablet count or millilitres from experience." }, { "zh": "这张 DailyMed 图只对应历史 PAXIL 20 mg 片剂标签。包装图、片剂颜色或刻字是核对线索，不是鉴定真伪的工具，也不能证明另一个市场、另一种强度、混悬剂或其他帕罗西汀产品相同。", "en": "This DailyMed image corresponds only to a historical PAXIL 20 mg tablet label. Package artwork, tablet colour or imprint are checking clues, not tools to authenticate a medicine, and cannot prove that another market, strength, suspension or paroxetine product is the same." }, { "zh": "标签将与其他影响血清素、凝血或代谢的药物，以及 MAOI 相关转换，列为需要专业核对的事项。请把全部处方药、非处方药、补充剂和近期变动交给药师或开方团队；不要因同属抗抑郁药或名称相近而自行叠加、轮换或替换。", "en": "The label identifies other medicines that affect serotonin, clotting or metabolism, and MAOI-related transitions, as issues requiring professional review. Give the pharmacist or prescribing team all prescription medicines, non-prescription products, supplements and recent changes; do not self-combine, alternate or substitute because products share an antidepressant class or similar name." }, { "zh": "FDA 标签提示停用可能出现不良反应，并要求由专业人员处理逐步减量。若有想停药、换药、漏服、情绪或行为突然变化，或出现紧急安全风险，应联系开方团队并使用当地紧急支持；不要根据剩余药量、包装图或网页自行骤停。", "en": "The FDA label notes that discontinuation may cause adverse reactions and that a professional should manage gradual reduction. With a wish to stop, a switch, missed use, sudden mood or behaviour change, or an urgent safety risk, contact the prescribing team and use local emergency support; do not abruptly stop from remaining medication, a package image or a webpage." } ], "source": { "id": "src_e8ad8b16b3a54002", "label": "FDA：PAXIL 2024 美国标签（剂型、强度、相互作用与停用警示）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/020031s083%2C020710s051lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "帕罗西汀怎样起作用：与中枢神经系统的血清素再摄取有关", "en": "How paroxetine works: it is linked to serotonin reuptake in the central nervous system" }, "summary": { "zh": "FDA 2024 标签将 PAXIL 描述为选择性血清素再摄取抑制剂，并说明其用于多种情况的机制尚不清楚，但推测与抑制中枢神经系统神经元对血清素的再摄取、从而增强血清素活动有关。这用于解释机制文字，不预测个人症状、适用性、片数、起效时间或转换方案。", "en": "The 2024 FDA label describes PAXIL as a selective serotonin reuptake inhibitor and states that its mechanism across its uses is unknown but presumed linked to inhibition of CNS neuronal serotonin reuptake, increasing serotonergic activity. This explains mechanism wording; it does not predict an individual's symptoms, suitability, tablet count, onset or switching plan." }, "checks": [ { "zh": "“影响血清素再摄取”是药理路径，不是某个人该选择哪一种抗抑郁药、是否需要基因检测、何时见效或是否能自行加减的答案。需要结合完整病史、实际产品、全部药单和现行标签由专业人员判断。", "en": "‘Affects serotonin reuptake’ is a pharmacologic pathway, not an answer to which antidepressant someone should choose, whether genetic testing is needed, when an effect will occur or whether self-adjustment is possible. These questions require professional judgement using the full history, actual product, complete medicine list and current label." }, { "zh": "同属 SSRI、都涉及血清素，或包装名称不同，都不表示可以自行叠加、隔天轮换或从一种药直接换到另一种。FDA 标签把与其他影响血清素药物及 MAOI 的关系列为需要明确核对的安全问题。", "en": "Sharing the SSRI class, serotonin involvement or different package names does not permit self-combination, alternate-day rotation or a direct change from one medicine to another. The FDA label identifies relationships with other serotonin-affecting medicines and MAOIs as safety questions needing explicit review." }, { "zh": "机制阅读不能替代对停用、漏服、妊娠相关顾虑、异常出血、情绪或行为变化的个体处理。出现担忧时应带上实际包装和完整药单联系开方团队；紧急安全风险应使用当地紧急医疗或危机支持。", "en": "Mechanism reading cannot replace individual handling of discontinuation, missed use, pregnancy-related concerns, unusual bleeding, or mood and behaviour changes. With concerns, contact the prescribing team with the actual package and complete medicine list; use local emergency medical or crisis support for urgent safety risk." } ], "source": { "id": "src_e8ad8b16b3a54002", "label": "FDA：PAXIL 2024 美国标签（12.1 Mechanism of Action）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/020031s083%2C020710s051lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "Paxil", "generic": "帕罗西汀", "dosageFormClass": "口服片剂（10、20、30、40 mg）及口服混悬剂（10 mg/5 mL；标签注明当时未上市）" }, "labelSource": { "id": "src_e8ad8b16b3a54002", "label": "FDA：PAXIL 2024 美国标签（NDA 020031 / 020710）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/020031s083%2C020710s051lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "productRoutes": [ { "source": { "id": "src_e8ad8b16b3a54002", "label": "FDA：PAXIL 2024 美国标签（NDA 020031 / 020710）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/020031s083%2C020710s051lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_e7eb34ccc3076418", "label": "DailyMed（NLM）：PAXIL 历史公开标签（GlaxoSmithKline，2012-01-05）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=40226242-da82-4dd7-bca2-eebb14501264", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "FDA 的 PAXIL（paroxetine）2024 美国标签列示 10、20、30、40 mg 口服片剂及 10 mg/5 mL 口服混悬剂，并列出美国初始批准年份为 1992。DailyMed 还保留 2012 年历史标签中可逐项核对的 20 mg、30 mg 口服片瓶装身份卡。本页将它们作为来源可追溯的放大阅读入口；不据此推定中国大陆或其他市场的当前批准、包装、持有人、原研关系、供应或可售资格。", "history": "PAXIL、帕罗西汀、片剂或口服混悬剂、每单位标示强度/浓度、标签版本和目标市场必须一起核对。四张美国历史文字身份卡只对应 20 mg 或 30 mg、30 片或 60 片的具体瓶装；相同通用名、相近颜色、相同数字或片剂刻痕都不能确认其他包装的身份、真实性、可掰开性或可替代性。", "sourceDocuments": [ { "id": "src_e8ad8b16b3a54002", "label": "FDA：PAXIL 2024 美国标签（NDA 020031 / 020710）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/020031s083%2C020710s051lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_e7eb34ccc3076418", "label": "DailyMed（NLM）：PAXIL 历史公开标签（GlaxoSmithKline，2012-01-05）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=40226242-da82-4dd7-bca2-eebb14501264", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_5ed30b676fbb9773", "label": "FDA Drugs@FDA 官方检索入口", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_lookup_entry", "documentKind": "regulatory_lookup", "market": "US", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } ], "applicationNumber": "NDA 020031 / 020710", "approvalTimeline": [ { "date": "1992", "title": { "zh": "FDA 标签所列美国初始批准年份", "en": "Initial U.S. approval year listed in the FDA label" }, "detail": { "zh": "本页链接的 FDA 标签档案列示 Initial U.S. Approval: 1992。该历史定位不等同于当前批准、可得性、持有人或其他市场状态。", "en": "The FDA label archive linked here lists Initial U.S. Approval: 1992. This historical locator is not a conclusion about current approval, availability, holder or another market." }, "source": { "id": "src_e8ad8b16b3a54002", "label": "FDA: PAXIL label archive", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/020031s083%2C020710s051lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, { "date": "2024", "title": { "zh": "FDA 标签档案版本", "en": "FDA label archive version" }, "detail": { "zh": "本页链接 2024 的 FDA 标签档案作为可复核阅读入口。现行标签、规格、适应症和安全信息必须另行以目标市场当前文件核对。", "en": "This page links the 2024 FDA label archive as a traceable reading entry point. Current labeling, strength, indication and safety information require separate verification against the target market’s current document." }, "source": { "id": "src_e8ad8b16b3a54002", "label": "FDA: PAXIL label archive", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/020031s083%2C020710s051lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "已链接公开标签档案", "en": "Public label archive linked" }, "detail": { "zh": "仅对应本页所列 FDA 文件。", "en": "Only the FDA document listed on this page is linked." } }, { "market": { "zh": "中国大陆、欧盟、日本", "en": "Mainland China, EU, Japan" }, "status": { "zh": "待逐项建立市场记录", "en": "Market record not established" }, "detail": { "zh": "不从美国标签档案推定当地批准、持有人、规格、供应或可售资格。", "en": "No local approval, holder, strength, supply or sale-eligibility conclusion is inferred from the U.S. label archive." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "标签档案能代表现在的产品信息吗？", "en": "Does a label archive represent current product information?" }, "answer": { "zh": "不能自动代表。档案用于定位来源；需要以目标市场的现行官方标签逐项复核。", "en": "Not automatically. The archive locates a source; each point needs verification against the target market’s current official label." } }, { "question": { "zh": "为什么这里不展示价格或原研/仿制结论？", "en": "Why are price and originator/generic conclusions not shown?" }, "answer": { "zh": "这些结论需要产品、剂型、规格、包装、市场、日期和原始记录分别齐全并经人工审核；单一标签文件不足以支持。", "en": "Those conclusions require separately complete and human-reviewed product, dosage-form, strength, pack, market, date and primary-record fields; one label file is insufficient." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "how-to-read-a-drug-label", "regulatory-sources-first" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/paxil/", "en": "https://origindrug.com/en/drugs/paxil/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "cymbalta", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-23", "status": "published_traceable_archive" }, "names": { "brand": "Cymbalta", "generic": "度洛西汀", "aliases": [ "duloxetine" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "精神健康", "sourceArchiveMarket": "美国 DailyMed 公开标签（SPL v90，2025-08-11 发布；页面 2025-07-21 更新）。本档案只建立标签明确列出的 20 mg、30 mg、60 mg 延迟释放口服胶囊及三种准确瓶装身份；不从该资料推定中国大陆、欧盟、日本或其他市场的商品名、批准、供应、可得性或可替代性。", "dosageFormClass": "度洛西汀盐酸盐延迟释放口服胶囊：20 mg、30 mg、60 mg（美国公开标签所列；本页分别展示 60 粒、30 粒、30 粒瓶装）", "dosageFormClassCode": "oral_modified_release", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "2004（DailyMed 当前美国公开标签所列美国初始批准）", "archiveSponsorText": "Eli Lilly and Company / DailyMed 当前美国公开标签" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-cymbalta-duloxetine-delayed-release-capsule-20mg-60-bottle-ndc-0002323560", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v90，2025-08-11 发布；仅为所引公开标签展示面，不代表供应", "en": "DailyMed SPL v90, published 11 Aug 2025; cited public label panel only, not availability" }, "dosageForm": { "zh": "CYMBALTA 度洛西汀盐酸盐延迟释放口服胶囊", "en": "CYMBALTA duloxetine hydrochloride delayed-release oral capsule" }, "route": { "zh": "口服（标签产品身份字段）", "en": "oral (label product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 0002-3235-60", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_capsule", "primaryDisplay": { "zh": "每粒度洛西汀 20 mg；60 粒瓶装", "en": "Duloxetine 20 mg per capsule; 60-capsule bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=cymbalta-20mg-contain-049-02.jpg&setid=2f7d4d67-10c1-4bf4-a7f2-c185fbad64ba&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "度洛西汀", "en": "duloxetine" }, "value": 20, "unit": "mg", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒标签标示量；不是个人粒数、减量、停用、联用或换药指令", "en": "labelled amount per capsule; not an individual capsule count, taper, stop, co-use or switching instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 60, "countUnit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-23", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 60, "unit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "physicalClues": { "color": { "zh": "不透明绿色（胶囊帽与囊体）", "en": "opaque green cap and body" }, "shape": { "zh": "延迟释放胶囊；无刻痕", "en": "delayed-release capsule; no score" }, "imprint": "Lilly 3235 / 20 mg", "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_e344a22522eb72a9", "label": "DailyMed（NLM）：CYMBALTA 度洛西汀盐酸盐当前美国公开标签（Eli Lilly；SPL v90，2025-08-11 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=2f7d4d67-10c1-4bf4-a7f2-c185fbad64ba", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-cymbalta-duloxetine-delayed-release-capsule-30mg-30-bottle-ndc-0002324030", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v90，2025-08-11 发布；仅为所引公开标签展示面，不代表供应", "en": "DailyMed SPL v90, published 11 Aug 2025; cited public label panel only, not availability" }, "dosageForm": { "zh": "CYMBALTA 度洛西汀盐酸盐延迟释放口服胶囊", "en": "CYMBALTA duloxetine hydrochloride delayed-release oral capsule" }, "route": { "zh": "口服（标签产品身份字段）", "en": "oral (label product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 0002-3240-30", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_capsule", "primaryDisplay": { "zh": "每粒度洛西汀 30 mg；30 粒瓶装", "en": "Duloxetine 30 mg per capsule; 30-capsule bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=cymbalta-30mg-contain-063-03.jpg&setid=2f7d4d67-10c1-4bf4-a7f2-c185fbad64ba&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "度洛西汀", "en": "duloxetine" }, "value": 30, "unit": "mg", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒标签标示量；不是个人粒数、减量、停用、联用或换药指令", "en": "labelled amount per capsule; not an individual capsule count, taper, stop, co-use or switching instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-23", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 30, "unit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "physicalClues": { "color": { "zh": "不透明蓝色胶囊帽、白色囊体", "en": "opaque blue cap and white body" }, "shape": { "zh": "延迟释放胶囊；无刻痕", "en": "delayed-release capsule; no score" }, "imprint": "Lilly 3240 / 30 mg", "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_e344a22522eb72a9", "label": "DailyMed（NLM）：CYMBALTA 度洛西汀盐酸盐当前美国公开标签（Eli Lilly；SPL v90，2025-08-11 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=2f7d4d67-10c1-4bf4-a7f2-c185fbad64ba", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-cymbalta-duloxetine-delayed-release-capsule-60mg-30-bottle-ndc-0002327030", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v90，2025-08-11 发布；仅为所引公开标签展示面，不代表供应", "en": "DailyMed SPL v90, published 11 Aug 2025; cited public label panel only, not availability" }, "dosageForm": { "zh": "CYMBALTA 度洛西汀盐酸盐延迟释放口服胶囊", "en": "CYMBALTA duloxetine hydrochloride delayed-release oral capsule" }, "route": { "zh": "口服（标签产品身份字段）", "en": "oral (label product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 0002-3270-30", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_capsule", "primaryDisplay": { "zh": "每粒度洛西汀 60 mg；30 粒瓶装", "en": "Duloxetine 60 mg per capsule; 30-capsule bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=cymbalta-60mg-contain-052-02.jpg&setid=2f7d4d67-10c1-4bf4-a7f2-c185fbad64ba&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "度洛西汀", "en": "duloxetine" }, "value": 60, "unit": "mg", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒标签标示量；不是个人粒数、减量、停用、联用或换药指令", "en": "labelled amount per capsule; not an individual capsule count, taper, stop, co-use or switching instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-23", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 30, "unit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "physicalClues": { "color": { "zh": "不透明蓝色胶囊帽、绿色囊体", "en": "opaque blue cap and green body" }, "shape": { "zh": "延迟释放胶囊；无刻痕", "en": "delayed-release capsule; no score" }, "imprint": "Lilly 3270 / 60 mg", "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_e344a22522eb72a9", "label": "DailyMed（NLM）：CYMBALTA 度洛西汀盐酸盐当前美国公开标签（Eli Lilly；SPL v90，2025-08-11 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=2f7d4d67-10c1-4bf4-a7f2-c185fbad64ba", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-cymbalta-duloxetine-delayed-release-capsule-30mg-30-bottle-ndc-0002324030", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=cymbalta-30mg-contain-063-03.jpg&setid=2f7d4d67-10c1-4bf4-a7f2-c185fbad64ba&type=img", "alt": "CYMBALTA 30 mg 度洛西汀延迟释放胶囊、NDC 0002-3240-30、30 粒瓶装在美国 DailyMed 当前公开标签中的包装面板", "archiveMarket": "美国", "labelVersion": "DailyMed SPL v90（2025-08-11 发布；页面 2025-07-21 更新）", "presentation": "CYMBALTA 度洛西汀 30 mg、NDC 0002-3240-30、30 粒延迟释放胶囊瓶装包装面板（DailyMed SPL v90 所列）。", "notice": "此图只对应美国 DailyMed SPL v90 中 CYMBALTA、度洛西汀 30 mg、NDC 0002-3240-30 与 30 粒瓶装。它只帮助核对品牌、通用名、每粒标示量、延迟释放胶囊、包装数量与来源；不用于鉴定真伪，也不证明 20 mg、60 mg、90 粒瓶装、其他市场、当前供应、原研身份、可替代性或任何个人的粒数、联用、减量、停用或换药方案。", "source": { "id": "src_e344a22522eb72a9", "label": "DailyMed（NLM）：CYMBALTA 度洛西汀盐酸盐当前美国公开标签（Eli Lilly；SPL v90，2025-08-11 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=2f7d4d67-10c1-4bf4-a7f2-c185fbad64ba", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "CYMBALTA 说明书放大阅读：肠溶胶囊的释放设计不能靠经验改动", "en": "CYMBALTA label reading: an enteric-coated capsule’s release design is not changed by experience" }, "summary": { "zh": "本模块以 DailyMed 2025 美国公开标签为阅读入口，帮助识别 CYMBALTA 的 20 mg、30 mg、60 mg 延迟释放胶囊、标示强度和联用/停用边界；它不决定个人服用数量、打开胶囊、减量或转换计划。", "en": "This module uses the 2025 U.S. DailyMed public label as a reading entry point. It helps identify CYMBALTA 20 mg, 30 mg and 60 mg delayed-release capsules, labelled strength and combination/discontinuation boundaries; it does not decide individual capsule count, opening, tapering or switching." }, "checks": [ { "zh": "先核对 CYMBALTA、度洛西汀、肠溶胶囊、每粒标示强度和目标市场。相同通用名、相似用途或相近 mg 数字，不能证明与另一种普通胶囊、片剂或精神科药可自行替代。", "en": "Check CYMBALTA, duloxetine, delayed-release capsule, labelled strength per capsule and target market together. A shared generic name, similar use or nearby mg number does not prove interchangeability with another ordinary capsule, tablet or psychiatric medicine." }, { "zh": "肠溶/缓释相关的释放设计不能由“打开、咀嚼、压碎、对半或混入食物”来凭经验处理。任何操作问题必须回到准确产品的现行标签与药师指导，不把网页当作改造制剂的说明书。", "en": "Enteric/delayed-release design cannot be handled by experience through opening, chewing, crushing, halving or mixing with food. Any handling question must return to the current label and pharmacist guidance for the exact product; a webpage is not instructions for altering a formulation." }, { "zh": "标签涉及肝脏、血压、出血倾向、酒精和其他影响血清素的药物等需要核对的情形。多药并用时应将所有处方药、非处方药、草本和饮酒情况一起告诉专业人员。", "en": "The label identifies situations needing review involving the liver, blood pressure, bleeding tendency, alcohol and other serotonin-affecting medicines. With multiple medicines, tell a professional about every prescription, OTC product, herb and alcohol use together." }, { "zh": "不要因为疼痛、情绪或睡眠感受变化自行突然停用、加量或换成另一种药。减量、停用和转换需要开方团队安排；出现严重精神症状或急性不适时应走当地医疗支持渠道。", "en": "Do not suddenly self-stop, increase or change to another medicine because pain, mood or sleep changes. Tapering, stopping and conversion need a prescribing-team plan; severe psychiatric symptoms or an acute concern need local medical-support pathways." } ], "source": { "id": "src_e344a22522eb72a9", "label": "DailyMed（NLM）：CYMBALTA 度洛西汀盐酸盐当前美国公开标签（Eli Lilly；SPL v90，2025-08-11 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=2f7d4d67-10c1-4bf4-a7f2-c185fbad64ba", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "度洛西汀怎样起作用：它抑制血清素与去甲肾上腺素再摄取", "en": "How duloxetine works: it inhibits serotonin and norepinephrine reuptake" }, "summary": { "zh": "FDA 标签将度洛西汀描述为血清素和去甲肾上腺素再摄取抑制剂。机制可以帮助理解联用与停用为何需要专业核对，但不用于判断个人疼痛、情绪、剂量、疗效或适用性。", "en": "The FDA label describes duloxetine as a serotonin and norepinephrine reuptake inhibitor. Mechanism helps explain why combinations and discontinuation need professional review, but does not determine individual pain, mood, dose, benefit or suitability." }, "checks": [ { "zh": "同一机制不让度洛西汀与其他抗抑郁、止痛、偏头痛、咳嗽感冒或草本产品可自行叠加或替换。应将完整药单交由专业人员按具体情形核对。", "en": "A shared mechanism does not make duloxetine self-combinable or interchangeable with other antidepressant, pain, migraine, cough/cold or herbal products. A professional should review the complete medicine list in the specific context." }, { "zh": "机制不能判断肠溶胶囊是否可以掰开、打开、研碎或改用另一剂型，也不能形成任何个人减量或停用公式。", "en": "Mechanism cannot determine whether a delayed-release capsule can be split, opened, crushed or changed to another form, nor create any individual tapering or stopping formula." }, { "zh": "肝脏、饮酒、血压、出血相关风险和急性精神健康问题都需依据现行标签、实际情况和当地专业支持处理。", "en": "Liver, alcohol, blood-pressure, bleeding-related risks and acute mental-health concerns need handling through the current label, real circumstances and local professional support." } ], "source": { "id": "src_64d746a2487fb35e", "label": "FDA：CYMBALTA 2014 美国处方信息（临床药理）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021427s045lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "Cymbalta", "generic": "度洛西汀", "dosageFormClass": "度洛西汀盐酸盐延迟释放口服胶囊：20 mg、30 mg、60 mg（美国公开标签所列；本页分别展示 60 粒、30 粒、30 粒瓶装）" }, "labelSource": { "id": "src_e344a22522eb72a9", "label": "DailyMed（NLM）：CYMBALTA 度洛西汀盐酸盐当前美国公开标签（Eli Lilly；SPL v90，2025-08-11 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=2f7d4d67-10c1-4bf4-a7f2-c185fbad64ba", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "productRoutes": [ { "source": { "id": "src_e344a22522eb72a9", "label": "DailyMed（NLM）：CYMBALTA 度洛西汀盐酸盐当前美国公开标签（Eli Lilly；SPL v90，2025-08-11 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=2f7d4d67-10c1-4bf4-a7f2-c185fbad64ba", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_64d746a2487fb35e", "label": "FDA：CYMBALTA 2014 美国标签档案（NDA 021427；历史文件）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021427s045lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "DailyMed 的 CYMBALTA（duloxetine hydrochloride）当前美国公开标签列有 20 mg、30 mg、60 mg 延迟释放口服胶囊。本页分别建立三种准确瓶装面板的品牌、通用名、每粒标示量、NDC、外观线索和一手来源核对卡；不把包装数字变成个人粒数、减量、停用、联用、转换或购买结论。", "history": "本页只建立 DailyMed SPL v90 所列的 CYMBALTA 20 mg（NDC 0002-3235-60，60 粒瓶装）、30 mg（NDC 0002-3240-30，30 粒瓶装）和 60 mg（NDC 0002-3270-30，30 粒瓶装）身份。延迟释放、不同 mg、颜色或瓶装数量都是产品核对字段；它们不能自行回答应服几粒、能否打开/咀嚼/掰开、怎样减量，或能否与其他影响血清素的药物合用。", "sourceDocuments": [ { "id": "src_e344a22522eb72a9", "label": "DailyMed（NLM）：CYMBALTA 度洛西汀盐酸盐当前美国公开标签（Eli Lilly；SPL v90，2025-08-11 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=2f7d4d67-10c1-4bf4-a7f2-c185fbad64ba", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_64d746a2487fb35e", "label": "FDA：CYMBALTA 2014 美国标签档案（NDA 021427；历史文件）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021427s045lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_5ed30b676fbb9773", "label": "FDA Drugs@FDA 官方检索入口", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_lookup_entry", "documentKind": "regulatory_lookup", "market": "US", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } ], "applicationNumber": "NDA 021427", "approvalTimeline": [ { "date": "2004", "title": { "zh": "FDA 标签所列美国初始批准年份", "en": "Initial U.S. approval year listed in the FDA label" }, "detail": { "zh": "本页链接的 FDA 标签档案列示 Initial U.S. Approval: 2004。该历史定位不等同于当前批准、可得性、持有人或其他市场状态。", "en": "The FDA label archive linked here lists Initial U.S. Approval: 2004. This historical locator is not a conclusion about current approval, availability, holder or another market." }, "source": { "id": "src_64d746a2487fb35e", "label": "FDA: CYMBALTA label archive", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021427s045lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, { "date": "2014", "title": { "zh": "FDA 标签档案版本", "en": "FDA label archive version" }, "detail": { "zh": "本页链接 2014 的 FDA 标签档案作为可复核阅读入口。现行标签、规格、适应症和安全信息必须另行以目标市场当前文件核对。", "en": "This page links the 2014 FDA label archive as a traceable reading entry point. Current labeling, strength, indication and safety information require separate verification against the target market’s current document." }, "source": { "id": "src_64d746a2487fb35e", "label": "FDA: CYMBALTA label archive", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021427s045lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "已链接公开标签档案", "en": "Public label archive linked" }, "detail": { "zh": "仅对应本页所列 FDA 文件。", "en": "Only the FDA document listed on this page is linked." } }, { "market": { "zh": "中国大陆、欧盟、日本", "en": "Mainland China, EU, Japan" }, "status": { "zh": "待逐项建立市场记录", "en": "Market record not established" }, "detail": { "zh": "不从美国标签档案推定当地批准、持有人、规格、供应或可售资格。", "en": "No local approval, holder, strength, supply or sale-eligibility conclusion is inferred from the U.S. label archive." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "标签档案能代表现在的产品信息吗？", "en": "Does a label archive represent current product information?" }, "answer": { "zh": "不能自动代表。档案用于定位来源；需要以目标市场的现行官方标签逐项复核。", "en": "Not automatically. The archive locates a source; each point needs verification against the target market’s current official label." } }, { "question": { "zh": "为什么这里不展示价格或原研/仿制结论？", "en": "Why are price and originator/generic conclusions not shown?" }, "answer": { "zh": "这些结论需要产品、剂型、规格、包装、市场、日期和原始记录分别齐全并经人工审核；单一标签文件不足以支持。", "en": "Those conclusions require separately complete and human-reviewed product, dosage-form, strength, pack, market, date and primary-record fields; one label file is insufficient." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "how-to-read-a-drug-label", "regulatory-sources-first" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/cymbalta/", "en": "https://origindrug.com/en/drugs/cymbalta/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "lexapro", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-23", "status": "published_traceable_archive" }, "names": { "brand": "Lexapro", "generic": "艾司西酞普兰", "aliases": [ "escitalopram" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "精神健康", "sourceArchiveMarket": "美国 DailyMed 公开标签（Allergan，2023-10 更新）。本档案仅建立 5 mg、10 mg、20 mg 各一款 100 片瓶装标签面板；同页口服溶液、单位剂量包装、其他市场和后续版本须分别核对。", "dosageFormClass": "艾司西酞普兰口服薄膜衣片：5 mg、10 mg、20 mg（本页分别展示三个 100 片瓶装）；同页另有 1 mg/mL 口服溶液，不能与片剂混作一种产品", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "2002（DailyMed 2023 美国公开标签所列初始批准）", "archiveSponsorText": "Allergan / DailyMed 公开监管标签档案" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-lexapro-escitalopram-tablet-5mg-100-bottle-ndc-0456200501", "marketCode": "US", "labelVersion": { "zh": "DailyMed 美国公开标签（Allergan；2023-10 更新）；仅为所引公开标签展示面，不代表供应", "en": "U.S. DailyMed public label (Allergan; updated Oct 2023); cited public label panel only, not availability" }, "dosageForm": { "zh": "LEXAPRO 艾司西酞普兰口服薄膜衣片", "en": "LEXAPRO escitalopram film-coated oral tablet" }, "route": { "zh": "口服（标签产品身份字段）", "en": "oral (label product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 0456-2005-01", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片艾司西酞普兰 5 mg；100 片瓶装", "en": "Escitalopram 5 mg per tablet; 100-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=lexapro-02.jpg&setid=13bb8267-1cab-43e5-acae-55a4d957630a&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "艾司西酞普兰", "en": "escitalopram" }, "value": 5, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、分割、转换、停用、联用或换药指令", "en": "labelled amount per tablet; not an individual's tablet count, splitting, conversion, stopping, co-use or switching instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-23", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "白色", "en": "white" }, "shape": { "zh": "圆形片（约 6 mm）", "en": "round tablet (about 6 mm)" }, "imprint": "FL / 5", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_12bf4c52da877ec6", "label": "DailyMed（NLM）：LEXAPRO 艾司西酞普兰美国公开标签（Allergan，2023-10 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=13bb8267-1cab-43e5-acae-55a4d957630a", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-lexapro-escitalopram-tablet-10mg-100-bottle-ndc-0456201001", "marketCode": "US", "labelVersion": { "zh": "DailyMed 美国公开标签（Allergan；2023-10 更新）；仅为所引公开标签展示面，不代表供应", "en": "U.S. DailyMed public label (Allergan; updated Oct 2023); cited public label panel only, not availability" }, "dosageForm": { "zh": "LEXAPRO 艾司西酞普兰口服薄膜衣片", "en": "LEXAPRO escitalopram film-coated oral tablet" }, "route": { "zh": "口服（标签产品身份字段）", "en": "oral (label product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 0456-2010-01", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片艾司西酞普兰 10 mg；100 片瓶装", "en": "Escitalopram 10 mg per tablet; 100-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=lexapro-03.jpg&setid=13bb8267-1cab-43e5-acae-55a4d957630a&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "艾司西酞普兰", "en": "escitalopram" }, "value": 10, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、分割、转换、停用、联用或换药指令", "en": "labelled amount per tablet; not an individual's tablet count, splitting, conversion, stopping, co-use or switching instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-23", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "白色", "en": "white" }, "shape": { "zh": "圆形片（约 7 mm）", "en": "round tablet (about 7 mm)" }, "imprint": "F / L / 10", "scoreStatus": "scored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_12bf4c52da877ec6", "label": "DailyMed（NLM）：LEXAPRO 艾司西酞普兰美国公开标签（Allergan，2023-10 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=13bb8267-1cab-43e5-acae-55a4d957630a", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-lexapro-escitalopram-tablet-20mg-100-bottle-ndc-0456202001", "marketCode": "US", "labelVersion": { "zh": "DailyMed 美国公开标签（Allergan；2023-10 更新）；仅为所引公开标签展示面，不代表供应", "en": "U.S. DailyMed public label (Allergan; updated Oct 2023); cited public label panel only, not availability" }, "dosageForm": { "zh": "LEXAPRO 艾司西酞普兰口服薄膜衣片", "en": "LEXAPRO escitalopram film-coated oral tablet" }, "route": { "zh": "口服（标签产品身份字段）", "en": "oral (label product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 0456-2020-01", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片艾司西酞普兰 20 mg；100 片瓶装", "en": "Escitalopram 20 mg per tablet; 100-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=lexapro-04.jpg&setid=13bb8267-1cab-43e5-acae-55a4d957630a&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "艾司西酞普兰", "en": "escitalopram" }, "value": 20, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、分割、转换、停用、联用或换药指令", "en": "labelled amount per tablet; not an individual's tablet count, splitting, conversion, stopping, co-use or switching instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-23", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "白色", "en": "white" }, "shape": { "zh": "圆形片（约 10 mm）", "en": "round tablet (about 10 mm)" }, "imprint": "F / L / 20", "scoreStatus": "scored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_12bf4c52da877ec6", "label": "DailyMed（NLM）：LEXAPRO 艾司西酞普兰美国公开标签（Allergan，2023-10 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=13bb8267-1cab-43e5-acae-55a4d957630a", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": null, "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=lexapro-02.jpg&setid=13bb8267-1cab-43e5-acae-55a4d957630a&type=img", "alt": "LEXAPRO 5 mg 艾司西酞普兰片在美国 DailyMed 公开标签中的 AbbVie 100 片瓶装标签图", "archiveMarket": "美国", "labelVersion": "DailyMed 公开标签（Allergan/AbbVie，2023-10 更新）", "presentation": "LEXAPRO 5 mg、100 片瓶装标签图（DailyMed 公开标签所列；AbbVie 标签图）。", "notice": "此为美国 DailyMed 公开标签中明确对应 LEXAPRO 5 mg、100 片装的 AbbVie 标签图，只帮助核对品牌、通用名、标示强度、片剂、包装数量和来源；不用于鉴定真伪，也不证明 10 mg/20 mg、口服溶液、其他包装、其他市场标签、当前包装、原研身份、目标市场批准或可售资格。", "source": { "id": "src_12bf4c52da877ec6", "label": "DailyMed（NLM）：LEXAPRO 公开标签（Allergan，2023-10 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=13bb8267-1cab-43e5-acae-55a4d957630a", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "LEXAPRO 说明书放大阅读：不同片剂、口服溶液与停药问题不能只看 mg", "en": "LEXAPRO label reading: tablet, oral-solution and stopping questions cannot be answered from mg alone" }, "summary": { "zh": "本模块以 Allergan 的 DailyMed 2023-10 美国公开标签为阅读入口，帮助核对 LEXAPRO、艾司西酞普兰、5/10/20 mg 片剂或 1 mg/mL 口服溶液、包装和目标市场；它不提供个人用量、停药、转换或联用方案。", "en": "This module uses Allergan's October 2023 U.S. DailyMed public label as a reading entry point. It helps check LEXAPRO, escitalopram, 5/10/20 mg tablets or 1 mg/mL oral solution, package and target market; it does not provide an individual's amount, stopping, switching or combination plan." }, "checks": [ { "zh": "5、10、20 mg 是片剂的标示强度；1 mg/mL 是口服溶液的浓度。它们不是同一种标注方式，不能把“几片”自行换成“几毫升”，也不能以相同通用名或相近数字推定产品可以互换。", "en": "5, 10 and 20 mg are labelled tablet strengths; 1 mg/mL is an oral-solution concentration. They are not the same type of label, do not support self-conversion from “tablets” to “millilitres,” and do not make products interchangeable because the generic name or a number looks similar." }, { "zh": "该标签列示 10 mg、20 mg 片有刻痕，5 mg 片无刻痕。刻痕只是这份准确标签中的外观/制剂信息，不是对任何片剂自行掰开、凑量、加减或替换的通用许可；实际包装应请药师或开方团队核对。", "en": "This label lists scored 10 mg and 20 mg tablets and a non-scored 5 mg tablet. A score is appearance/formulation information in this exact label, not universal permission to split, combine, adjust or substitute any tablet; have the actual package checked by a pharmacist or prescribing team." }, { "zh": "公开标签提示停用相关症状，并提出应逐步处理而非突然中断。不要因短期情绪、睡眠、胃肠道不适、余药或网上经验自行突然停用、隔日服用、借用他人的药或换成其他抗抑郁药。", "en": "The public label notes discontinuation-related symptoms and calls for gradual rather than sudden handling. Do not abruptly self-stop, take it on alternating days, use someone else’s medicine or change to another antidepressant because of short-term mood, sleep, gastrointestinal symptoms, leftover medicine or online experience." }, { "zh": "标签列出与其他影响血清素药物、MAOI、止痛药、偏头痛药、草本和其他产品有关的联用风险线索。家中全部处方药、非处方药、补充剂与饮酒情况应一起交给药师或开方团队，网页不能判断个人能否同服或怎样转换。", "en": "The label lists combination-risk clues involving other serotonin-affecting medicines, MAOIs, pain and migraine medicines, herbs and other products. Bring every prescription, OTC product, supplement and alcohol use together to a pharmacist or prescribing team; a webpage cannot determine individual combination or switching." }, { "zh": "出现新的或加重的自伤想法、明显激越/意识变化、昏厥、抽搐，或疑似严重不适时，应使用当地急诊、危机干预或医疗支持渠道；不要等待网页或自行改药。", "en": "With new or worsening self-harm thoughts, marked agitation/mental-status change, fainting, seizure or a suspected serious reaction, use local emergency, crisis or medical-support channels; do not wait for a webpage or self-change a medicine." } ], "source": { "id": "src_12bf4c52da877ec6", "label": "DailyMed（NLM）：LEXAPRO 公开标签（Allergan，2023-10 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=13bb8267-1cab-43e5-acae-55a4d957630a", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "艾司西酞普兰怎样起作用：它是选择性血清素再摄取抑制剂", "en": "How escitalopram works: it is a selective serotonin reuptake inhibitor" }, "summary": { "zh": "DailyMed 标签将 LEXAPRO 描述为选择性血清素再摄取抑制剂（SSRI）。这解释它影响血清素信号的药理路径，但不预测个人情绪反应，也不决定个人是否适用、应服多少、何时停用或如何换药。", "en": "The DailyMed label describes LEXAPRO as a selective serotonin reuptake inhibitor (SSRI). This explains a pharmacologic pathway involving serotonin signalling, but does not predict an individual's mood response or decide suitability, amount, stopping or switching." }, "checks": [ { "zh": "同为 SSRI，或都“影响血清素”，不表示 LEXAPRO 能与另一种抗抑郁药、止痛药、偏头痛药、镇咳感冒产品、草本或补充剂自行叠加、轮换或替代。所有产品和完整药单都必须由专业人员逐项核对。", "en": "Being an SSRI, or both “affecting serotonin,” does not make LEXAPRO self-combinable, alternatable or substitutable with another antidepressant, pain medicine, migraine medicine, cough/cold product, herb or supplement. Every product and the complete list need item-by-item professional review." }, { "zh": "选择性再摄取抑制的机制不能把 5、10、20 mg 或片剂/溶液转换为个人剂量、减量或换药规则。每种剂型、标示、目标市场、既往情况与其他用药都需回到实际包装、现行标签和开方团队。", "en": "A selective-reuptake-inhibition mechanism cannot turn 5, 10 or 20 mg, or tablet/solution form, into individual dosing, tapering or switching rules. Each form, marking, target market, history and other medicine must return to the actual package, current label and prescribing team." }, { "zh": "机制也不能用来自行解释新的焦躁、睡眠变化、头晕、跌倒风险、意识改变或自伤想法。出现急性或严重问题时，应优先使用当地紧急和专业支持，而不是从药理名词推导操作。", "en": "Mechanism also cannot be used to self-explain new agitation, sleep change, dizziness, fall risk, mental-status change or self-harm thoughts. With an acute or serious concern, prioritise local urgent and professional support rather than derive an action from pharmacology terms." } ], "source": { "id": "src_12bf4c52da877ec6", "label": "DailyMed（NLM）：LEXAPRO 公开标签（Allergan，2023-10 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=13bb8267-1cab-43e5-acae-55a4d957630a", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "Lexapro", "generic": "艾司西酞普兰", "dosageFormClass": "艾司西酞普兰口服薄膜衣片：5 mg、10 mg、20 mg（本页分别展示三个 100 片瓶装）；同页另有 1 mg/mL 口服溶液，不能与片剂混作一种产品" }, "labelSource": { "id": "src_12bf4c52da877ec6", "label": "DailyMed（NLM）：LEXAPRO 公开标签（Allergan，2023-10 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=13bb8267-1cab-43e5-acae-55a4d957630a", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "productRoutes": [ { "source": { "id": "src_12bf4c52da877ec6", "label": "DailyMed（NLM）：LEXAPRO 公开标签（Allergan，2023-10 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=13bb8267-1cab-43e5-acae-55a4d957630a", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_da9815ebf7d41137", "label": "FDA：LEXAPRO 2021 美国标签（NDA 021365 / 021323）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021365s038%2C021323s053lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "DailyMed 的 LEXAPRO（escitalopram）2023 美国公开标签列示 5 mg、10 mg、20 mg 口服片与 1 mg/mL 口服溶液。本页分别建立三个 100 片瓶装片剂面板的品牌、通用名、每片标示量、NDC、外观线索和一手来源核对卡；不把包装数字变成个人片数、分割、停用、联用、转换或购买结论。", "history": "本页的三个包装面板仅对应 LEXAPRO 5 mg（NDC 0456-2005-01）、10 mg（NDC 0456-2010-01）与 20 mg（NDC 0456-2020-01）各 100 片瓶装。10 mg 与 20 mg 的刻痕只是这些准确片剂的外观/制剂线索，不能成为自行分割、加减、换药或把片剂换算为同页口服溶液的许可。涉及突然停用或与其他影响血清素药物联用时，必须回到现行标签和专业团队。", "sourceDocuments": [ { "id": "src_12bf4c52da877ec6", "label": "DailyMed（NLM）：LEXAPRO 公开标签（Allergan，2023-10 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=13bb8267-1cab-43e5-acae-55a4d957630a", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_da9815ebf7d41137", "label": "FDA：LEXAPRO 2021 美国标签（NDA 021365 / 021323）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021365s038%2C021323s053lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_5ed30b676fbb9773", "label": "FDA Drugs@FDA 官方检索入口", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_lookup_entry", "documentKind": "regulatory_lookup", "market": "US", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } ], "applicationNumber": "NDA 021365 / 021323", "approvalTimeline": [ { "date": "2002", "title": { "zh": "FDA 标签所列美国初始批准年份", "en": "Initial U.S. approval year listed in the FDA label" }, "detail": { "zh": "本页链接的 FDA 标签档案列示 Initial U.S. Approval: 2002。该历史定位不等同于当前批准、可得性、持有人或其他市场状态。", "en": "The FDA label archive linked here lists Initial U.S. Approval: 2002. This historical locator is not a conclusion about current approval, availability, holder or another market." }, "source": { "id": "src_da9815ebf7d41137", "label": "FDA: LEXAPRO label archive", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021365s038%2C021323s053lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, { "date": "2021-09", "title": { "zh": "FDA 标签档案版本", "en": "FDA label archive version" }, "detail": { "zh": "本页链接 2021-09 的 FDA 标签档案作为可复核阅读入口。现行标签、规格、适应症和安全信息必须另行以目标市场当前文件核对。", "en": "This page links the 2021-09 FDA label archive as a traceable reading entry point. Current labeling, strength, indication and safety information require separate verification against the target market’s current document." }, "source": { "id": "src_da9815ebf7d41137", "label": "FDA: LEXAPRO label archive", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021365s038%2C021323s053lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "已链接公开标签档案", "en": "Public label archive linked" }, "detail": { "zh": "仅对应本页所列 FDA 文件。", "en": "Only the FDA document listed on this page is linked." } }, { "market": { "zh": "中国大陆、欧盟、日本", "en": "Mainland China, EU, Japan" }, "status": { "zh": "待逐项建立市场记录", "en": "Market record not established" }, "detail": { "zh": "不从美国标签档案推定当地批准、持有人、规格、供应或可售资格。", "en": "No local approval, holder, strength, supply or sale-eligibility conclusion is inferred from the U.S. label archive." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "标签档案能代表现在的产品信息吗？", "en": "Does a label archive represent current product information?" }, "answer": { "zh": "不能自动代表。档案用于定位来源；需要以目标市场的现行官方标签逐项复核。", "en": "Not automatically. The archive locates a source; each point needs verification against the target market’s current official label." } }, { "question": { "zh": "为什么这里不展示价格或原研/仿制结论？", "en": "Why are price and originator/generic conclusions not shown?" }, "answer": { "zh": "这些结论需要产品、剂型、规格、包装、市场、日期和原始记录分别齐全并经人工审核；单一标签文件不足以支持。", "en": "Those conclusions require separately complete and human-reviewed product, dosage-form, strength, pack, market, date and primary-record fields; one label file is insufficient." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "how-to-read-a-drug-label", "regulatory-sources-first" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/lexapro/", "en": "https://origindrug.com/en/drugs/lexapro/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "effexor", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-23", "status": "published_traceable_archive" }, "names": { "brand": "Effexor", "generic": "文拉法辛", "aliases": [ "venlafaxine" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "精神健康", "sourceArchiveMarket": "美国 DailyMed 公开标签（Wyeth Pharmaceuticals LLC / Pfizer，2022-08 修订）。本页只建立 37.5、75、150 mg 三个 30 粒瓶装展示面；15 粒/90 粒瓶装、100 粒泡罩盒、其他市场和后续版本须逐项分开核对。", "dosageFormClass": "文拉法辛盐酸盐缓释口服胶囊：37.5 mg、75 mg、150 mg；三种强度与普通文拉法辛制剂不是同一产品身份", "dosageFormClassCode": "oral_modified_release", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "1997（DailyMed 公开标签所列美国初始批准）", "archiveSponsorText": "Wyeth Pharmaceuticals LLC（Pfizer 子公司）/ DailyMed（NLM）公开标签" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-effexor-xr-venlafaxine-extended-release-capsule-37-5-mg-30-bottle-ndc-0008083721", "marketCode": "US", "labelVersion": { "zh": "DailyMed 美国公开标签（Wyeth Pharmaceuticals LLC / Pfizer；2022-08 修订）；仅为所引公开标签展示面，不代表供应", "en": "U.S. DailyMed public label (Wyeth Pharmaceuticals LLC / Pfizer; revised Aug 2022); cited label panel only, not availability" }, "dosageForm": { "zh": "EFFEXOR XR 文拉法辛盐酸盐缓释口服胶囊", "en": "EFFEXOR XR venlafaxine hydrochloride extended-release oral capsule" }, "route": { "zh": "口服（标签产品身份字段）", "en": "oral (label product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 0008-0837-21", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_capsule", "primaryDisplay": { "zh": "每粒文拉法辛 37.5 mg；30 粒瓶装", "en": "Venlafaxine 37.5 mg per capsule; 30-capsule bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=effexorxr-06.jpg&archiveid=898589", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "文拉法辛", "en": "venlafaxine" }, "value": 37.5, "unit": "mg", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒标签标示量；不是个人粒数、减量、停用、联用或换药指令", "en": "labelled amount per capsule; not an individual capsule count, taper, stop, co-use or switching instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-23", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 30, "unit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "physicalClues": { "color": { "zh": "灰色帽、桃色囊体", "en": "grey cap and peach body" }, "shape": { "zh": "缓释胶囊；无刻痕", "en": "extended-release capsule; no score" }, "imprint": "W / Effexor XR / 37.5", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_01ecd7e435a59ec8", "label": "DailyMed（NLM）：EFFEXOR XR 文拉法辛盐酸盐美国公开标签（Wyeth Pharmaceuticals LLC / Pfizer，2022-08 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=53c3e7ac-1852-4d70-d2b6-4fca819acf26", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-effexor-xr-venlafaxine-extended-release-capsule-75-mg-30-bottle-ndc-0008083321", "marketCode": "US", "labelVersion": { "zh": "DailyMed 美国公开标签（Wyeth Pharmaceuticals LLC / Pfizer；2022-08 修订）；仅为所引公开标签展示面，不代表供应", "en": "U.S. DailyMed public label (Wyeth Pharmaceuticals LLC / Pfizer; revised Aug 2022); cited label panel only, not availability" }, "dosageForm": { "zh": "EFFEXOR XR 文拉法辛盐酸盐缓释口服胶囊", "en": "EFFEXOR XR venlafaxine hydrochloride extended-release oral capsule" }, "route": { "zh": "口服（标签产品身份字段）", "en": "oral (label product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 0008-0833-21", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_capsule", "primaryDisplay": { "zh": "每粒文拉法辛 75 mg；30 粒瓶装", "en": "Venlafaxine 75 mg per capsule; 30-capsule bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=effexorxr-09.jpg&archiveid=898589", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "文拉法辛", "en": "venlafaxine" }, "value": 75, "unit": "mg", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒标签标示量；不是个人粒数、减量、停用、联用或换药指令", "en": "labelled amount per capsule; not an individual capsule count, taper, stop, co-use or switching instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-23", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 30, "unit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "physicalClues": { "color": { "zh": "桃色帽与囊体", "en": "peach cap and body" }, "shape": { "zh": "缓释胶囊；无刻痕", "en": "extended-release capsule; no score" }, "imprint": "W / Effexor XR / 75", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_01ecd7e435a59ec8", "label": "DailyMed（NLM）：EFFEXOR XR 文拉法辛盐酸盐美国公开标签（Wyeth Pharmaceuticals LLC / Pfizer，2022-08 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=53c3e7ac-1852-4d70-d2b6-4fca819acf26", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-effexor-xr-venlafaxine-extended-release-capsule-150-mg-30-bottle-ndc-0008083621", "marketCode": "US", "labelVersion": { "zh": "DailyMed 美国公开标签（Wyeth Pharmaceuticals LLC / Pfizer；2022-08 修订）；仅为所引公开标签展示面，不代表供应", "en": "U.S. DailyMed public label (Wyeth Pharmaceuticals LLC / Pfizer; revised Aug 2022); cited label panel only, not availability" }, "dosageForm": { "zh": "EFFEXOR XR 文拉法辛盐酸盐缓释口服胶囊", "en": "EFFEXOR XR venlafaxine hydrochloride extended-release oral capsule" }, "route": { "zh": "口服（标签产品身份字段）", "en": "oral (label product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 0008-0836-21", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_capsule", "primaryDisplay": { "zh": "每粒文拉法辛 150 mg；30 粒瓶装", "en": "Venlafaxine 150 mg per capsule; 30-capsule bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=effexorxr-12.jpg&archiveid=898589", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "文拉法辛", "en": "venlafaxine" }, "value": 150, "unit": "mg", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒标签标示量；不是个人粒数、减量、停用、联用或换药指令", "en": "labelled amount per capsule; not an individual capsule count, taper, stop, co-use or switching instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-23", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 30, "unit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "physicalClues": { "color": { "zh": "深橙色帽与囊体", "en": "dark-orange cap and body" }, "shape": { "zh": "缓释胶囊；无刻痕", "en": "extended-release capsule; no score" }, "imprint": "W / Effexor XR / 150", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_01ecd7e435a59ec8", "label": "DailyMed（NLM）：EFFEXOR XR 文拉法辛盐酸盐美国公开标签（Wyeth Pharmaceuticals LLC / Pfizer，2022-08 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=53c3e7ac-1852-4d70-d2b6-4fca819acf26", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": null, "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=effexorxr-06.jpg&archiveid=898589", "alt": "EFFEXOR XR 37.5 mg 文拉法辛盐酸盐缓释胶囊在美国 DailyMed 公开标签中的 Pfizer 30 粒装瓶身标签图", "archiveMarket": "美国", "labelVersion": "DailyMed 公开标签（Wyeth/Pfizer，2022-08 更新）", "presentation": "EFFEXOR XR 37.5 mg、30 粒缓释胶囊瓶身标签图（DailyMed 公开标签所列；Wyeth/Pfizer 标签图）。", "notice": "此为美国 DailyMed 公开标签中明确对应 EFFEXOR XR 37.5 mg、30 粒缓释胶囊的 Wyeth/Pfizer 标签图，只帮助核对品牌、通用名、标示强度、缓释胶囊、包装数量和来源；不用于鉴定真伪，也不证明 75 mg/150 mg、其他包装、其他市场标签、当前包装、原研身份、目标市场批准或可售资格。", "source": { "id": "src_01ecd7e435a59ec8", "label": "DailyMed（NLM）：EFFEXOR XR 公开标签（Wyeth/Pfizer，2022-08 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=53c3e7ac-1852-4d70-d2b6-4fca819acf26", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "EFFEXOR XR 说明书放大阅读：缓释胶囊不是“掰半就减半”的普通胶囊", "en": "EFFEXOR XR label reading: an extended-release capsule is not an ordinary capsule to halve" }, "summary": { "zh": "本模块以 FDA 2021 美国标签为阅读入口，帮助识别 EFFEXOR XR 的缓释胶囊、标示强度与产品特定操作边界；它不提供个人片数、吞服方式、减量或转换方案。", "en": "This module uses the 2021 U.S. FDA label as a reading entry point. It helps identify EFFEXOR XR extended-release capsules, labelled strength and product-specific handling boundaries; it does not provide an individual capsule count, swallowing method, taper or conversion plan." }, "checks": [ { "zh": "先核对 EFFEXOR XR、文拉法辛、缓释胶囊、每粒标示强度和目标市场。名称中“XR/缓释”是剂型身份的一部分，不等于另一种普通片、普通胶囊或同类药可以按毫克数直接换算。", "en": "Check EFFEXOR XR, venlafaxine, extended-release capsule, labelled strength per capsule and target market first. “XR/extended release” is part of dosage-form identity; it does not make an immediate-release tablet, ordinary capsule or same-class medicine directly convertible by milligrams." }, { "zh": "EFFEXOR XR 的美国公开标签列有 37.5、75、150 mg 缓释胶囊，并明确“整粒吞服，不掰分、不压碎、不咀嚼、不溶于水”。该标签也为这一准确胶囊列出无法整粒吞服时的特定打开/撒服方式；这是该产品标签的例外，不能推广为所有缓释胶囊都可打开、掰开或按经验“减半”。", "en": "The U.S. public EFFEXOR XR label lists 37.5, 75 and 150 mg extended-release capsules and states that capsules are swallowed whole, not divided, crushed, chewed or dissolved. It also lists a specific opening/sprinkling method for this exact capsule when whole swallowing is not possible; that is a product-label exception, not permission to open, split or ‘halve’ every extended-release capsule." }, { "zh": "标签对与 MAOI、其他影响血清素/去甲肾上腺素的药物及多药联用有相关警示。把止痛、咳嗽感冒、偏头痛、助眠、草本、酒精和所有处方药一起交由药师或开方团队核对。", "en": "The label has relevant warnings about MAOIs, other serotonin/norepinephrine-affecting medicines and multiple medicines. Take pain, cough/cold, migraine, sleep, herbal, alcohol and every prescription product together to a pharmacist or prescribing team for review." }, { "zh": "不要因为短期感受变化、困倦或担心不适自行突然停用、隔天轮换或拿别人的药替代。任何减量、停用或转换均需由开方团队安排；急性精神健康风险应走当地紧急支持渠道。", "en": "Do not suddenly self-stop, irregularly alternate or use someone else’s medicine because of short-term feelings, drowsiness or concern about symptoms. Any taper, stop or conversion needs a prescribing-team plan; acute mental-health risk needs local urgent support." } ], "source": { "id": "src_3869103cc46c54f8", "label": "FDA：EFFEXOR XR 2021 美国处方信息（NDA 020699）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020699s113lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "文拉法辛怎样起作用：它影响血清素与去甲肾上腺素再摄取", "en": "How venlafaxine works: it affects serotonin and norepinephrine reuptake" }, "summary": { "zh": "FDA 标签将文拉法辛及其活性代谢物描述为血清素和去甲肾上腺素再摄取抑制剂。这说明药理路径，不是对个人情绪、疼痛、血压、剂量或是否应换药的预测。", "en": "The FDA label describes venlafaxine and its active metabolite as serotonin and norepinephrine reuptake inhibitors. This explains a pharmacologic pathway, not an individual prediction about mood, pain, blood pressure, dose or whether to change medicines." }, "checks": [ { "zh": "“影响两种信号”不使同类或其他精神科药物能自行叠加、互换或按毫克数换算。产品剂型、既往反应、全部用药和开方原因都需要一并复核。", "en": "“Affecting two signals” does not make same-class or other psychiatric medicines self-combinable, interchangeable or convertible by milligrams. Dosage form, prior responses, all medicines and the prescribing reason need review together." }, { "zh": "机制不能推断缓释胶囊是否可改变释放方式，也不能给出开始、加量、减量或停用方案。此类问题必须回到现行标签与专业团队。", "en": "Mechanism cannot determine whether an extended-release capsule’s release can be altered, or supply a start, increase, taper or stop plan. Those questions must return to the current label and professional team." }, { "zh": "涉及血压、其他影响血清素/去甲肾上腺素的药物、饮酒或急性精神健康风险时，应使用当地专业支持，而不是从本页调整药物。", "en": "With blood-pressure issues, other serotonin/norepinephrine-affecting medicines, alcohol or acute mental-health risk, use local professional support rather than adjust medicine from this page." } ], "source": { "id": "src_3869103cc46c54f8", "label": "FDA：EFFEXOR XR 2021 美国处方信息（临床药理）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020699s113lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "Effexor", "generic": "文拉法辛", "dosageFormClass": "文拉法辛盐酸盐缓释口服胶囊：37.5 mg、75 mg、150 mg；三种强度与普通文拉法辛制剂不是同一产品身份" }, "labelSource": { "id": "src_01ecd7e435a59ec8", "label": "DailyMed（NLM）：EFFEXOR XR 文拉法辛盐酸盐美国公开标签（Wyeth Pharmaceuticals LLC / Pfizer，2022-08 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=53c3e7ac-1852-4d70-d2b6-4fca819acf26", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "productRoutes": [ { "source": { "id": "src_01ecd7e435a59ec8", "label": "DailyMed（NLM）：EFFEXOR XR 文拉法辛盐酸盐美国公开标签（Wyeth Pharmaceuticals LLC / Pfizer，2022-08 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=53c3e7ac-1852-4d70-d2b6-4fca819acf26", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_3869103cc46c54f8", "label": "FDA：EFFEXOR XR 2021 美国标签（NDA 020699；历史文件）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020699s113lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "DailyMed 的 EFFEXOR XR（venlafaxine hydrochloride）美国公开标签列示 37.5、75、150 mg 缓释口服胶囊。本页分别展示三款 30 粒瓶装的品牌、通用名、每粒标示量、NDC、颜色线索与一手来源；不把包装上的毫克数变成个人粒数、减量、停用、联用或换药结论。", "history": "本页的三个包装面板仅对应 EFFEXOR XR 37.5 mg（NDC 0008-0837-21）、75 mg（NDC 0008-0833-21）和 150 mg（NDC 0008-0836-21）各 30 粒瓶装。它们都是缓释胶囊；相同品牌、相近毫克数、颜色或包装数量不能把它们与普通文拉法辛、其他规格、泡罩包装或其他市场产品视为可自行互换。涉及吞服、减量、停用、转换或多药并用，应回到准确产品的现行标签并由药师或开方团队核对。", "sourceDocuments": [ { "id": "src_01ecd7e435a59ec8", "label": "DailyMed（NLM）：EFFEXOR XR 文拉法辛盐酸盐美国公开标签（Wyeth Pharmaceuticals LLC / Pfizer，2022-08 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=53c3e7ac-1852-4d70-d2b6-4fca819acf26", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_3869103cc46c54f8", "label": "FDA：EFFEXOR XR 2021 美国标签（NDA 020699；历史文件）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020699s113lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_5ed30b676fbb9773", "label": "FDA Drugs@FDA 官方检索入口", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_lookup_entry", "documentKind": "regulatory_lookup", "market": "US", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } ], "applicationNumber": "NDA 020699", "approvalTimeline": [ { "date": "2021-11", "title": { "zh": "FDA 标签档案版本", "en": "FDA label archive version" }, "detail": { "zh": "本页链接 2021-11 的 FDA 标签档案作为可复核阅读入口。现行标签、规格、适应症和安全信息必须另行以目标市场当前文件核对。", "en": "This page links the 2021-11 FDA label archive as a traceable reading entry point. Current labeling, strength, indication and safety information require separate verification against the target market’s current document." }, "source": { "id": "src_3869103cc46c54f8", "label": "FDA: EFFEXOR XR label archive", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020699s113lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "已链接公开标签档案", "en": "Public label archive linked" }, "detail": { "zh": "仅对应本页所列 FDA 文件。", "en": "Only the FDA document listed on this page is linked." } }, { "market": { "zh": "中国大陆、欧盟、日本", "en": "Mainland China, EU, Japan" }, "status": { "zh": "待逐项建立市场记录", "en": "Market record not established" }, "detail": { "zh": "不从美国标签档案推定当地批准、持有人、规格、供应或可售资格。", "en": "No local approval, holder, strength, supply or sale-eligibility conclusion is inferred from the U.S. label archive." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "标签档案能代表现在的产品信息吗？", "en": "Does a label archive represent current product information?" }, "answer": { "zh": "不能自动代表。档案用于定位来源；需要以目标市场的现行官方标签逐项复核。", "en": "Not automatically. The archive locates a source; each point needs verification against the target market’s current official label." } }, { "question": { "zh": "为什么这里不展示价格或原研/仿制结论？", "en": "Why are price and originator/generic conclusions not shown?" }, "answer": { "zh": "这些结论需要产品、剂型、规格、包装、市场、日期和原始记录分别齐全并经人工审核；单一标签文件不足以支持。", "en": "Those conclusions require separately complete and human-reviewed product, dosage-form, strength, pack, market, date and primary-record fields; one label file is insufficient." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "how-to-read-a-drug-label", "regulatory-sources-first" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/effexor/", "en": "https://origindrug.com/en/drugs/effexor/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "abilify", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-23", "status": "published_traceable_archive" }, "names": { "brand": "Abilify", "generic": "阿立哌唑", "aliases": [ "aripiprazole" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "精神健康", "sourceArchiveMarket": "美国 DailyMed 当前公开标签（2025-01-29 更新；本档案分别建立六种 30 片瓶装面板；不代表供应）", "dosageFormClass": "ABILIFY 阿立哌唑口服片：2 mg、5 mg、10 mg、15 mg、20 mg、30 mg（美国公开标签所列；本页分别建立六种 30 片瓶装面板，不将 7/100 片泡罩包装、口崩片、口服溶液、短效肌内注射、长效注射或其他市场包装合并）", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "2002（DailyMed 当前美国公开标签所列初始批准）", "archiveSponsorText": "Otsuka America Pharmaceutical, Inc. / DailyMed 当前美国公开标签" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-abilify-aripiprazole-tablet-2mg-30-bottle-ndc-5914800613", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（2025-01-29 更新）；仅为所引公开标签展示面，不代表供应", "en": "Current U.S. DailyMed public label (updated 29 Jan 2025); cited public label panel only, not availability" }, "dosageForm": { "zh": "ABILIFY 阿立哌唑口服片", "en": "ABILIFY aripiprazole oral tablet" }, "route": { "zh": "口服（标签产品身份字段）", "en": "oral (label product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 59148-006-13", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片阿立哌唑 2 mg；30 片瓶装", "en": "Aripiprazole 2 mg per tablet; 30-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=abilify-2mg-bottle-label.jpg&setid=c040bd1d-45b7-49f2-93ea-aed7220b30ac&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "阿立哌唑", "en": "aripiprazole" }, "value": 2, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、基因检测、分割、联用、停用或换药指令", "en": "labelled amount per tablet; not an individual's tablet count, genetic-test, splitting, co-use, stopping or switching instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-23", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 30, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "绿色", "en": "green" }, "shape": { "zh": "改良矩形片；无刻痕", "en": "modified rectangle; no score" }, "imprint": "A-006 / 2", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_54936304bb15a230", "label": "DailyMed（NLM）：ABILIFY 阿立哌唑口服片当前美国公开标签（Otsuka；2025-01-29 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c040bd1d-45b7-49f2-93ea-aed7220b30ac", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-abilify-aripiprazole-tablet-5mg-30-bottle-ndc-5914800713", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（2025-01-29 更新）；仅为所引公开标签展示面，不代表供应", "en": "Current U.S. DailyMed public label (updated 29 Jan 2025); cited public label panel only, not availability" }, "dosageForm": { "zh": "ABILIFY 阿立哌唑口服片", "en": "ABILIFY aripiprazole oral tablet" }, "route": { "zh": "口服（标签产品身份字段）", "en": "oral (label product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 59148-007-13", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片阿立哌唑 5 mg；30 片瓶装", "en": "Aripiprazole 5 mg per tablet; 30-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=abilify-5mg-bottle-label.jpg&setid=c040bd1d-45b7-49f2-93ea-aed7220b30ac&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "阿立哌唑", "en": "aripiprazole" }, "value": 5, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、基因检测、分割、联用、停用或换药指令", "en": "labelled amount per tablet; not an individual's tablet count, genetic-test, splitting, co-use, stopping or switching instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-23", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 30, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "蓝色", "en": "blue" }, "shape": { "zh": "改良矩形片；无刻痕", "en": "modified rectangle; no score" }, "imprint": "A-007 / 5", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_54936304bb15a230", "label": "DailyMed（NLM）：ABILIFY 阿立哌唑口服片当前美国公开标签（Otsuka；2025-01-29 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c040bd1d-45b7-49f2-93ea-aed7220b30ac", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-abilify-aripiprazole-tablet-10mg-30-bottle-ndc-5914800813", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（2025-01-29 更新）；仅为所引公开标签展示面，不代表供应", "en": "Current U.S. DailyMed public label (updated 29 Jan 2025); cited public label panel only, not availability" }, "dosageForm": { "zh": "ABILIFY 阿立哌唑口服片", "en": "ABILIFY aripiprazole oral tablet" }, "route": { "zh": "口服（标签产品身份字段）", "en": "oral (label product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 59148-008-13", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片阿立哌唑 10 mg；30 片瓶装", "en": "Aripiprazole 10 mg per tablet; 30-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=abilify-10mg-bottle-label.jpg&setid=c040bd1d-45b7-49f2-93ea-aed7220b30ac&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "阿立哌唑", "en": "aripiprazole" }, "value": 10, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、基因检测、分割、联用、停用或换药指令", "en": "labelled amount per tablet; not an individual's tablet count, genetic-test, splitting, co-use, stopping or switching instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-23", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 30, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "粉红色", "en": "pink" }, "shape": { "zh": "改良矩形片；无刻痕", "en": "modified rectangle; no score" }, "imprint": "A-008 / 10", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_54936304bb15a230", "label": "DailyMed（NLM）：ABILIFY 阿立哌唑口服片当前美国公开标签（Otsuka；2025-01-29 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c040bd1d-45b7-49f2-93ea-aed7220b30ac", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-abilify-aripiprazole-tablet-15mg-30-bottle-ndc-5914800913", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（2025-01-29 更新）；仅为所引公开标签展示面，不代表供应", "en": "Current U.S. DailyMed public label (updated 29 Jan 2025); cited public label panel only, not availability" }, "dosageForm": { "zh": "ABILIFY 阿立哌唑口服片", "en": "ABILIFY aripiprazole oral tablet" }, "route": { "zh": "口服（标签产品身份字段）", "en": "oral (label product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 59148-009-13", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片阿立哌唑 15 mg；30 片瓶装", "en": "Aripiprazole 15 mg per tablet; 30-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=abilify-15mg-bottle-label.jpg&setid=c040bd1d-45b7-49f2-93ea-aed7220b30ac&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "阿立哌唑", "en": "aripiprazole" }, "value": 15, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、基因检测、分割、联用、停用或换药指令", "en": "labelled amount per tablet; not an individual's tablet count, genetic-test, splitting, co-use, stopping or switching instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-23", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 30, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "黄色", "en": "yellow" }, "shape": { "zh": "圆形片；无刻痕", "en": "round tablet; no score" }, "imprint": "A-009 / 15", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_54936304bb15a230", "label": "DailyMed（NLM）：ABILIFY 阿立哌唑口服片当前美国公开标签（Otsuka；2025-01-29 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c040bd1d-45b7-49f2-93ea-aed7220b30ac", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-abilify-aripiprazole-tablet-20mg-30-bottle-ndc-5914801013", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（2025-01-29 更新）；仅为所引公开标签展示面，不代表供应", "en": "Current U.S. DailyMed public label (updated 29 Jan 2025); cited public label panel only, not availability" }, "dosageForm": { "zh": "ABILIFY 阿立哌唑口服片", "en": "ABILIFY aripiprazole oral tablet" }, "route": { "zh": "口服（标签产品身份字段）", "en": "oral (label product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 59148-010-13", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片阿立哌唑 20 mg；30 片瓶装", "en": "Aripiprazole 20 mg per tablet; 30-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=abilify-20mg-bottle-label.jpg&setid=c040bd1d-45b7-49f2-93ea-aed7220b30ac&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "阿立哌唑", "en": "aripiprazole" }, "value": 20, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、基因检测、分割、联用、停用或换药指令", "en": "labelled amount per tablet; not an individual's tablet count, genetic-test, splitting, co-use, stopping or switching instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-23", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 30, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "白色", "en": "white" }, "shape": { "zh": "圆形片；无刻痕", "en": "round tablet; no score" }, "imprint": "A-010 / 20", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_54936304bb15a230", "label": "DailyMed（NLM）：ABILIFY 阿立哌唑口服片当前美国公开标签（Otsuka；2025-01-29 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c040bd1d-45b7-49f2-93ea-aed7220b30ac", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-abilify-aripiprazole-tablet-30mg-30-bottle-ndc-5914801113", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（2025-01-29 更新）；仅为所引公开标签展示面，不代表供应", "en": "Current U.S. DailyMed public label (updated 29 Jan 2025); cited public label panel only, not availability" }, "dosageForm": { "zh": "ABILIFY 阿立哌唑口服片", "en": "ABILIFY aripiprazole oral tablet" }, "route": { "zh": "口服（标签产品身份字段）", "en": "oral (label product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 59148-011-13", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片阿立哌唑 30 mg；30 片瓶装", "en": "Aripiprazole 30 mg per tablet; 30-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=abilify-30mg-bottle-label.jpg&setid=c040bd1d-45b7-49f2-93ea-aed7220b30ac&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "阿立哌唑", "en": "aripiprazole" }, "value": 30, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、基因检测、分割、联用、停用或换药指令", "en": "labelled amount per tablet; not an individual's tablet count, genetic-test, splitting, co-use, stopping or switching instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-23", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 30, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "粉红色", "en": "pink" }, "shape": { "zh": "圆形片；无刻痕", "en": "round tablet; no score" }, "imprint": "A-011 / 30", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_54936304bb15a230", "label": "DailyMed（NLM）：ABILIFY 阿立哌唑口服片当前美国公开标签（Otsuka；2025-01-29 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c040bd1d-45b7-49f2-93ea-aed7220b30ac", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-abilify-aripiprazole-tablet-2mg-30-bottle-ndc-5914800613", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=abilify-2mg-bottle-label.jpg&setid=c040bd1d-45b7-49f2-93ea-aed7220b30ac&type=img", "alt": "ABILIFY 阿立哌唑 2 mg、NDC 59148-006-13、30 片瓶装在美国 DailyMed 当前公开标签中的展示面", "archiveMarket": "美国", "labelVersion": "DailyMed 当前公开标签（2025-01-29 更新）", "presentation": "ABILIFY 阿立哌唑普通口服片：每片 2 mg，NDC 59148-006-13，30 片瓶装展示面。", "notice": "此图只对应美国 DailyMed 当前公开标签中的 ABILIFY、阿立哌唑 2 mg、NDC 59148-006-13 与 30 片瓶装。它只帮助核对品牌、通用名、每片标示量、普通口服片、包装数量、外观线索与来源；不用于鉴定真伪，也不证明 5/10/15/20/30 mg、7/100 片泡罩包装、口崩片、口服溶液、短效或长效注射剂、其他市场、原研身份、当前可得性、可替代性或任何个人的片数、基因检测、调量、联用、停用或换药方案。", "source": { "id": "src_54936304bb15a230", "label": "DailyMed（NLM）：ABILIFY 阿立哌唑口服片当前美国公开标签（Otsuka；2025-01-29 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c040bd1d-45b7-49f2-93ea-aed7220b30ac", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "ABILIFY 说明书放大阅读：同名的口服片、口崩片、溶液和注射剂不能混作一种药", "en": "ABILIFY label reading: same-name tablets, ODTs, solution and injections are not one interchangeable product" }, "summary": { "zh": "本模块以 Otsuka 的 DailyMed ABILIFY 口服片剂标签为阅读入口，帮助核对 ABILIFY、阿立哌唑、2/5/10/15/20/30 mg 口服片和目标市场；它不提供个人片数、基因检测解释、停药、转换或联用方案。", "en": "This module uses Otsuka's DailyMed ABILIFY oral-tablet label as a reading entry point. It helps check ABILIFY, aripiprazole, 2/5/10/15/20/30 mg oral tablets and target market; it does not provide an individual's tablet count, genetic-test interpretation, stopping, switching or combination plan." }, "checks": [ { "zh": "2、5、10、15、20、30 mg 首先是每片的标示强度，不是“今天该吃几片”的答案。不同强度、不同包装、不同市场或另一种阿立哌唑制剂，不能凭相近 mg 自行拼量、替换或交替。", "en": "2, 5, 10, 15, 20 and 30 mg first identify the stated strength per tablet; they are not an answer to “how many tablets today.” Different strengths, packs, markets or another aripiprazole formulation must not be self-combined, substituted or alternated because mg values look nearby." }, { "zh": "本页所引标签是口服片剂标签。ABILIFY DISCMELT 口崩片、口服溶液、短效肌内注射、ABILIFY MAINTENA 或其他长效注射剂，都需要各自准确的包装、给药途径和现行标签；不能从本页外观或口服片 mg 推导用法。", "en": "The label linked here is for oral tablets. ABILIFY DISCMELT ODT, oral solution, short-acting intramuscular injection, ABILIFY MAINTENA and another long-acting injection each need their own exact package, route and current label; this page’s appearance or oral-tablet mg cannot be used to derive their use." }, { "zh": "标签列出已知 CYP2D6 代谢能力较低，以及强 CYP2D6/CYP3A4 抑制剂或诱导剂等需要由开方团队处理的情形。这不意味着所有人都需要做全基因筛查，也不能凭一份基因报告、药名或网页自行改变任何药物。", "en": "The label lists known reduced CYP2D6 metabolism and strong CYP2D6/CYP3A4 inhibitors or inducers as situations for the prescribing team to manage. This does not mean everyone needs broad genetic screening, and a gene report, drug name or webpage cannot be used to self-change any medicine." }, { "zh": "标签对血糖/体重相关变化、嗜睡、冲动或强迫行为等问题有警示。新出现的强烈赌博、购物、进食或其他冲动，明显嗜睡、昏厥、严重僵硬发热、意识改变或自伤风险，应及时使用当地医疗或危机支持，而非自行增减或突然停药。", "en": "The label carries warnings about glucose/weight-related changes, somnolence and impulsive or compulsive behaviour. New intense gambling, shopping, eating or another urge, marked somnolence, fainting, severe rigidity with fever, mental-status change or self-harm risk need timely local medical or crisis support, not self-adjustment or sudden stopping." }, { "zh": "与其他抗精神病药、抗抑郁药、镇静药、抗感染药、草本、酒精或慢病药一起使用时，必须把完整药单和实际包装交给药师或开方团队。网页不能判断个人能否同用、如何停换或如何处理漏用。", "en": "With another antipsychotic, antidepressant, sedative, anti-infective, herb, alcohol or chronic-care medicine, give the complete list and actual packages to a pharmacist or prescribing team. A webpage cannot decide individual co-use, stopping/switching or how to handle a missed use." } ], "source": { "id": "src_54936304bb15a230", "label": "DailyMed（NLM）：ABILIFY 阿立哌唑口服片当前美国公开标签（Otsuka；2025-01-29 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c040bd1d-45b7-49f2-93ea-aed7220b30ac", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "阿立哌唑怎样起作用：标签描述其与多种多巴胺和血清素受体有关", "en": "How aripiprazole works: the label describes activity at several dopamine and serotonin receptors" }, "summary": { "zh": "DailyMed 的 ABILIFY 口服片剂标签说明：其作用机制尚不完全清楚，疗效可能与多巴胺 D₂、血清素 5-HT₁A 受体的部分激动作用，以及 5-HT₂A 受体拮抗作用共同有关。这只是机制概述，不预测个人反应，也不决定剂量、联合、转换或停药。", "en": "The DailyMed ABILIFY oral-tablet label says the mechanism is not fully known and efficacy may involve combined partial agonism at dopamine D2 and serotonin 5-HT1A receptors plus antagonism at 5-HT2A receptors. This is a mechanism overview, not a prediction of individual response or a decision about dose, combination, switching or stopping." }, "checks": [ { "zh": "“部分激动”“多巴胺”或“血清素”不是自己判断哪种精神科药更适合、能否叠加、隔日轮换或从一盒换到另一盒的工具。诊断、既往反应、全部药物、剂型与风险因素都需要专业团队整体判断。", "en": "“Partial agonist,” “dopamine” or “serotonin” is not a tool for deciding which psychiatric medicine fits someone, whether products can be combined, alternated or changed from one pack to another. Diagnosis, prior response, all medicines, formulation and risk factors need whole-person professional judgement." }, { "zh": "标签中的 CYP2D6/CYP3A4 代谢信息解释了为什么遗传信息、某些抗感染药、抗抑郁药、抗癫痫药和草本等不能只按名称判断。它不能替代药师进行相互作用复核，也不能给出个人基因检测或剂量结论。", "en": "The label’s CYP2D6/CYP3A4 metabolism information helps explain why genetic information, some anti-infectives, antidepressants, antiseizure medicines and herbs cannot be judged by name alone. It cannot replace pharmacist interaction review or give a personal genetics or dose conclusion." }, { "zh": "机制不能自行解释新的动作异常、强烈冲动、血糖变化、嗜睡或意识改变，也不能成为突然停药的理由。急性或严重症状应优先走当地医疗、急诊或危机支持渠道。", "en": "Mechanism cannot self-explain a new movement problem, intense urge, glucose change, somnolence or mental-status change, and it is not a reason for abrupt stopping. Acute or severe symptoms need local medical, emergency or crisis-support pathways first." } ], "source": { "id": "src_54936304bb15a230", "label": "DailyMed（NLM）：ABILIFY 阿立哌唑口服片当前美国公开标签（Otsuka；2025-01-29 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c040bd1d-45b7-49f2-93ea-aed7220b30ac", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "Abilify", "generic": "阿立哌唑", "dosageFormClass": "ABILIFY 阿立哌唑口服片：2 mg、5 mg、10 mg、15 mg、20 mg、30 mg（美国公开标签所列；本页分别建立六种 30 片瓶装面板，不将 7/100 片泡罩包装、口崩片、口服溶液、短效肌内注射、长效注射或其他市场包装合并）" }, "labelSource": { "id": "src_54936304bb15a230", "label": "DailyMed（NLM）：ABILIFY 阿立哌唑口服片当前美国公开标签（Otsuka；2025-01-29 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c040bd1d-45b7-49f2-93ea-aed7220b30ac", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "productRoutes": [ { "source": { "id": "src_54936304bb15a230", "label": "DailyMed（NLM）：ABILIFY 阿立哌唑口服片当前美国公开标签（Otsuka；2025-01-29 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c040bd1d-45b7-49f2-93ea-aed7220b30ac", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-23", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_ebc6170aca7648ae", "label": "FDA：ABILIFY 2014 美国标签档案（NDA 021436 / 021866 / 021729 / 021713；历史文件）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021436s036%2C021866s021%2C021729s020%2C021713s028lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-23", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "DailyMed 当前美国公开标签列有 ABILIFY（aripiprazole）2、5、10、15、20、30 mg 口服片；本页分别建立六种准确 30 片瓶装的品牌、通用名、每片标示量、NDC、外观线索和一手来源核对卡。它不把包装数字变成个人片数、基因检测、掰片、联用、停用、转换或购买结论。", "history": "本页只建立 DailyMed 2025-01-29 当前美国公开标签所列的 ABILIFY 2 mg（NDC 59148-006-13）、5 mg（59148-007-13）、10 mg（59148-008-13）、15 mg（59148-009-13）、20 mg（59148-010-13）与 30 mg（59148-011-13）六种 30 片瓶装身份。7/100 片泡罩包装、ABILIFY DISCMELT 口崩片、口服溶液、短效肌内注射、ABILIFY MAINTENA 等长效注射剂及其他市场产品不能按同名、相近 mg 或成分重叠并入本口服片档案。", "sourceDocuments": [ { "id": "src_54936304bb15a230", "label": "DailyMed（NLM）：ABILIFY 阿立哌唑口服片当前美国公开标签（Otsuka；2025-01-29 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c040bd1d-45b7-49f2-93ea-aed7220b30ac", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, { "id": "src_ebc6170aca7648ae", "label": "FDA：ABILIFY 2014 美国标签档案（NDA 021436 / 021866 / 021729 / 021713；历史文件）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021436s036%2C021866s021%2C021729s020%2C021713s028lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_5ed30b676fbb9773", "label": "FDA Drugs@FDA 官方检索入口", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_lookup_entry", "documentKind": "regulatory_lookup", "market": "US", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } ], "applicationNumber": "NDA 021436（当前 DailyMed ABILIFY 口服片标签所列）", "approvalTimeline": [ { "date": "2002", "title": { "zh": "FDA 标签所列美国初始批准年份", "en": "Initial U.S. approval year listed in the FDA label" }, "detail": { "zh": "本页链接的 FDA 标签档案列示 Initial U.S. Approval: 2002。该历史定位不等同于当前批准、可得性、持有人或其他市场状态。", "en": "The FDA label archive linked here lists Initial U.S. Approval: 2002. This historical locator is not a conclusion about current approval, availability, holder or another market." }, "source": { "id": "src_54936304bb15a230", "label": "DailyMed: ABILIFY current U.S. oral-tablet label", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c040bd1d-45b7-49f2-93ea-aed7220b30ac", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" } }, { "date": "2025-01-29", "title": { "zh": "FDA 标签档案版本", "en": "FDA label archive version" }, "detail": { "zh": "本页链接 2025-01-29 的 FDA 标签档案作为可复核阅读入口。现行标签、规格、适应症和安全信息必须另行以目标市场当前文件核对。", "en": "This page links the 2025-01-29 FDA label archive as a traceable reading entry point. Current labeling, strength, indication and safety information require separate verification against the target market’s current document." }, "source": { "id": "src_54936304bb15a230", "label": "DailyMed: ABILIFY current U.S. oral-tablet label", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c040bd1d-45b7-49f2-93ea-aed7220b30ac", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "已链接公开标签档案", "en": "Public label archive linked" }, "detail": { "zh": "仅对应本页所列 FDA 文件。", "en": "Only the FDA document listed on this page is linked." } }, { "market": { "zh": "中国大陆、欧盟、日本", "en": "Mainland China, EU, Japan" }, "status": { "zh": "待逐项建立市场记录", "en": "Market record not established" }, "detail": { "zh": "不从美国标签档案推定当地批准、持有人、规格、供应或可售资格。", "en": "No local approval, holder, strength, supply or sale-eligibility conclusion is inferred from the U.S. label archive." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "标签档案能代表现在的产品信息吗？", "en": "Does a label archive represent current product information?" }, "answer": { "zh": "不能自动代表。档案用于定位来源；需要以目标市场的现行官方标签逐项复核。", "en": "Not automatically. The archive locates a source; each point needs verification against the target market’s current official label." } }, { "question": { "zh": "为什么这里不展示价格或原研/仿制结论？", "en": "Why are price and originator/generic conclusions not shown?" }, "answer": { "zh": "这些结论需要产品、剂型、规格、包装、市场、日期和原始记录分别齐全并经人工审核；单一标签文件不足以支持。", "en": "Those conclusions require separately complete and human-reviewed product, dosage-form, strength, pack, market, date and primary-record fields; one label file is insufficient." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "how-to-read-a-drug-label", "regulatory-sources-first" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/abilify/", "en": "https://origindrug.com/en/drugs/abilify/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "xanax", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-23", "status": "published_traceable_archive" }, "names": { "brand": "Xanax", "generic": "阿普唑仑", "aliases": [ "alprazolam" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "精神健康", "sourceArchiveMarket": "美国有日期公开标签（页面 2023-01 更新；本页分别保留四种 100 片瓶装身份；不代表当前供应或可得性）", "dosageFormClass": "口服片剂（C-IV；0.25 mg、0.5 mg、1 mg、2 mg；有日期公开标签所列；四种准确 100 片瓶装分别建立；不与 XANAX XR 混同）", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "1981（FDA 与 DailyMed 标签所列美国初始批准）", "archiveSponsorText": "Pharmacia & Upjohn / DailyMed 公开监管标签档案" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-xanax-alprazolam-tablet-0-25mg-100-bottle-ndc-0009002901", "marketCode": "US", "labelVersion": { "zh": "DailyMed 有日期美国公开标签（页面 2023-01 更新）；仅为所引标签的准确包装展示面，不代表当前供应或可得性", "en": "Dated U.S. DailyMed public label (page updated Jan 2023); exact cited package panel only, not current supply or availability" }, "dosageForm": { "zh": "XANAX 阿普唑仑口服片（C-IV；非 XANAX XR）", "en": "XANAX alprazolam oral tablet (C-IV; not XANAX XR)" }, "route": { "zh": "口服（标签产品身份字段）", "en": "oral (label product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 0009-0029-01", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片阿普唑仑 0.25 mg；100 片瓶装", "en": "Alprazolam 0.25 mg per tablet; 100-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=image-02.jpg&setid=388e249d-b9b6-44c3-9f8f-880eced0239f&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "阿普唑仑", "en": "alprazolam" }, "value": 0.25, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、分割、减量、停用、联用或换药指令", "en": "labelled amount per tablet; not an individual's tablet count, splitting, tapering, stopping, co-use or switching instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-23", "currentLabelDisplayed": false, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "白色", "en": "white" }, "shape": { "zh": "椭圆形片；标签列示 2 等分刻痕", "en": "oval tablet; label lists 2-piece score" }, "imprint": "XANAX / 0 / 25", "scoreStatus": "scored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_04e1059d381d67d9", "label": "DailyMed（NLM）：XANAX 阿普唑仑有日期美国公开标签（Pharmacia & Upjohn；页面 2023-01 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=388e249d-b9b6-44c3-9f8f-880eced0239f", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-xanax-alprazolam-tablet-0-5mg-100-bottle-ndc-0009005501", "marketCode": "US", "labelVersion": { "zh": "DailyMed 有日期美国公开标签（页面 2023-01 更新）；仅为所引标签的准确包装展示面，不代表当前供应或可得性", "en": "Dated U.S. DailyMed public label (page updated Jan 2023); exact cited package panel only, not current supply or availability" }, "dosageForm": { "zh": "XANAX 阿普唑仑口服片（C-IV；非 XANAX XR）", "en": "XANAX alprazolam oral tablet (C-IV; not XANAX XR)" }, "route": { "zh": "口服（标签产品身份字段）", "en": "oral (label product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 0009-0055-01", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片阿普唑仑 0.5 mg；100 片瓶装", "en": "Alprazolam 0.5 mg per tablet; 100-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=image-03.jpg&setid=388e249d-b9b6-44c3-9f8f-880eced0239f&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "阿普唑仑", "en": "alprazolam" }, "value": 0.5, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、分割、减量、停用、联用或换药指令", "en": "labelled amount per tablet; not an individual's tablet count, splitting, tapering, stopping, co-use or switching instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-23", "currentLabelDisplayed": false, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "橙色（桃色）", "en": "orange (peach)" }, "shape": { "zh": "椭圆形片；标签列示 2 等分刻痕", "en": "oval tablet; label lists 2-piece score" }, "imprint": "XANAX / 0 / 5", "scoreStatus": "scored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_04e1059d381d67d9", "label": "DailyMed（NLM）：XANAX 阿普唑仑有日期美国公开标签（Pharmacia & Upjohn；页面 2023-01 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=388e249d-b9b6-44c3-9f8f-880eced0239f", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-xanax-alprazolam-tablet-1mg-100-bottle-ndc-0009009001", "marketCode": "US", "labelVersion": { "zh": "DailyMed 有日期美国公开标签（页面 2023-01 更新）；仅为所引标签的准确包装展示面，不代表当前供应或可得性", "en": "Dated U.S. DailyMed public label (page updated Jan 2023); exact cited package panel only, not current supply or availability" }, "dosageForm": { "zh": "XANAX 阿普唑仑口服片（C-IV；非 XANAX XR）", "en": "XANAX alprazolam oral tablet (C-IV; not XANAX XR)" }, "route": { "zh": "口服（标签产品身份字段）", "en": "oral (label product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 0009-0090-01", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片阿普唑仑 1 mg；100 片瓶装", "en": "Alprazolam 1 mg per tablet; 100-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=image-04.jpg&setid=388e249d-b9b6-44c3-9f8f-880eced0239f&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "阿普唑仑", "en": "alprazolam" }, "value": 1, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、分割、减量、停用、联用或换药指令", "en": "labelled amount per tablet; not an individual's tablet count, splitting, tapering, stopping, co-use or switching instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-23", "currentLabelDisplayed": false, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "蓝色", "en": "blue" }, "shape": { "zh": "椭圆形片；标签列示 2 等分刻痕", "en": "oval tablet; label lists 2-piece score" }, "imprint": "XANAX / 1 / 0", "scoreStatus": "scored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_04e1059d381d67d9", "label": "DailyMed（NLM）：XANAX 阿普唑仑有日期美国公开标签（Pharmacia & Upjohn；页面 2023-01 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=388e249d-b9b6-44c3-9f8f-880eced0239f", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-xanax-alprazolam-tablet-2mg-100-bottle-ndc-0009009401", "marketCode": "US", "labelVersion": { "zh": "DailyMed 有日期美国公开标签（页面 2023-01 更新）；仅为所引标签的准确包装展示面，不代表当前供应或可得性", "en": "Dated U.S. DailyMed public label (page updated Jan 2023); exact cited package panel only, not current supply or availability" }, "dosageForm": { "zh": "XANAX 阿普唑仑口服片（C-IV；非 XANAX XR）", "en": "XANAX alprazolam oral tablet (C-IV; not XANAX XR)" }, "route": { "zh": "口服（标签产品身份字段）", "en": "oral (label product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 0009-0094-01", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片阿普唑仑 2 mg；100 片瓶装", "en": "Alprazolam 2 mg per tablet; 100-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=image-05.jpg&setid=388e249d-b9b6-44c3-9f8f-880eced0239f&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "阿普唑仑", "en": "alprazolam" }, "value": 2, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、分割、减量、停用、联用或换药指令", "en": "labelled amount per tablet; not an individual's tablet count, splitting, tapering, stopping, co-use or switching instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-23", "currentLabelDisplayed": false, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "白色", "en": "white" }, "shape": { "zh": "椭圆形（长圆形）片；标签列示 4 等分刻痕", "en": "oval (oblong) tablet; label lists 4-piece score" }, "imprint": "XANAX / 2", "scoreStatus": "scored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_04e1059d381d67d9", "label": "DailyMed（NLM）：XANAX 阿普唑仑有日期美国公开标签（Pharmacia & Upjohn；页面 2023-01 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=388e249d-b9b6-44c3-9f8f-880eced0239f", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-xanax-alprazolam-tablet-0-5mg-100-bottle-ndc-0009005501", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=image-03.jpg&setid=388e249d-b9b6-44c3-9f8f-880eced0239f&type=img", "alt": "XANAX 0.5 mg 阿普唑仑口服片在美国 DailyMed 公开标签中的 Pfizer 100 片包装面板", "archiveMarket": "美国", "labelVersion": "DailyMed 公开标签（Pharmacia & Upjohn，2023-01 更新）", "presentation": "XANAX 阿普唑仑 0.5 mg、NDC 0009-0055-01、100 片瓶装面板（有日期公开标签所列）。", "notice": "此图只对应美国 DailyMed 有日期公开标签中的 XANAX、阿普唑仑 0.5 mg、NDC 0009-0055-01 与 100 片瓶装。页面另将 0.25 mg、1 mg、2 mg 的准确 100 片瓶装分开列出；刻痕只描述标签外观，绝不表示可以自行掰开、减量、停用、联用或换药。它不用于鉴定真伪；标签产品数据存在营销结束日期，因此本页不证明当前供应、在售、原研身份、目标市场批准或可售资格。", "source": { "id": "src_04e1059d381d67d9", "label": "DailyMed（NLM）：XANAX 阿普唑仑有日期美国公开标签（Pharmacia & Upjohn；页面 2023-01 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=388e249d-b9b6-44c3-9f8f-880eced0239f", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "XANAX 说明书放大阅读：镇静药不能按感觉自行加减或突然停用", "en": "XANAX label reading: a sedating medicine is not adjusted by feeling or stopped suddenly" }, "summary": { "zh": "本模块以 FDA 2023 美国标签为阅读入口，帮助阅读 XANAX 的产品身份、镇静风险、联用边界和停用警示；它不判断个人是否适合使用、应服几片、如何减量或能否替换另一种精神科药物。", "en": "This module uses the 2023 U.S. FDA label as a reading entry point. It helps read XANAX product identity, sedation risk, combination boundaries and discontinuation warnings; it does not decide individual suitability, tablet count, tapering or replacement with another psychiatric medicine." }, "checks": [ { "zh": "先核对 XANAX、阿普唑仑、准确剂型、每片标示强度和目标市场。相同的“助眠/镇静/抗焦虑”用途描述，不能证明另一种药、另一种强度或另一种缓释制剂可以自行替换。", "en": "Check XANAX, alprazolam, the exact dosage form, labelled strength per tablet and target market first. A shared “sleep/sedation/anxiety” description does not prove another medicine, strength or extended-release form can be self-substituted." }, { "zh": "FDA 标签对与阿片类、酒精或其他中枢神经系统抑制性药物同用提出重要警示。家中同时有止痛、止咳、助眠、抗过敏、饮酒或多种精神科药物时，应把全部药单和实际使用情况交由药师或医生核对。", "en": "The FDA label carries important warnings about use with opioids, alcohol or other central-nervous-system depressants. With pain, cough, sleep, allergy, alcohol or multiple psychiatric products at home, have a pharmacist or clinician review the complete list and actual use." }, { "zh": "标签提示有依赖、滥用、误用及突然减少或停止后的风险。不要因为感觉好一些、困倦，或担心副作用就自行加量、借给他人、隔天乱换或突然停用；减量和停用需要由开方团队制定。", "en": "The label warns about dependence, abuse, misuse and risks after abrupt reduction or discontinuation. Do not self-increase, share, irregularly alternate or suddenly stop because of feeling better, drowsiness or concern about adverse effects; tapering and discontinuation need a plan from the prescribing team." }, { "zh": "高龄、跌倒、呼吸问题、意识改变或与多种药物并用时风险评估更不能只靠网页。出现严重嗜睡、呼吸变慢、意识异常或其他急性情况时，应按当地急救和医疗指引及时处理。", "en": "With older age, falls, breathing problems, altered awareness or multiple medicines, risk assessment cannot come from a webpage alone. For severe drowsiness, slowed breathing, altered consciousness or another acute concern, use local emergency and medical guidance promptly." } ], "source": { "id": "src_04e1059d381d67d9", "label": "DailyMed（NLM）：XANAX 阿普唑仑有日期美国公开标签（Pharmacia & Upjohn；页面 2023-01 更新；Warnings and Precautions）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=388e249d-b9b6-44c3-9f8f-880eced0239f", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "阿普唑仑怎样起作用：它增强 GABA 介导的抑制性信号", "en": "How alprazolam works: it enhances GABA-mediated inhibitory signalling" }, "summary": { "zh": "FDA 标签将阿普唑仑描述为苯二氮䓬类药物，并说明其通过苯二氮䓬受体部位增强 GABA 介导的抑制作用。这个机制用于理解为何镇静、联用和停用问题需要谨慎；它不说明谁应使用、服几片或如何减量。", "en": "The FDA label describes alprazolam as a benzodiazepine and says it enhances GABA-mediated inhibition at benzodiazepine receptor sites. This helps explain why sedation, combination and discontinuation need care; it does not say who should use it, how many tablets to take or how to taper." }, "checks": [ { "zh": "“增强抑制性信号”不使任何人可以按感觉自行加量，或把镇静当成疗效指标。困倦、跌倒、呼吸问题与全部联用药都需专业人员按实际情况评估。", "en": "“Enhancing inhibitory signalling” does not let anyone self-increase use by feeling or treat sedation as an efficacy marker. Drowsiness, falls, breathing concerns and all co-medications need professional assessment in the actual context." }, { "zh": "机制解释不了不同苯二氮䓬类或其他精神科药物之间的个人换算或替代。药名相近、用途相似或同样会困，都不足以建立可自行换药的依据。", "en": "Mechanism does not provide individual conversion or substitution between benzodiazepines or other psychiatric medicines. Similar names, uses or drowsiness do not establish a basis for self-switching." }, { "zh": "长期使用、减量、突然停用和与酒精、阿片类或其他镇静药联用的问题，都需要回到准确产品的现行标签、完整药单和开方团队，而不是从药理名词推断。", "en": "Long-term use, tapering, abrupt discontinuation and combinations with alcohol, opioids or other sedatives must return to the current label for the exact product, the complete medicine list and the prescribing team, not be inferred from pharmacology terms." } ], "source": { "id": "src_04e1059d381d67d9", "label": "DailyMed（NLM）：XANAX 阿普唑仑有日期美国公开标签（Pharmacia & Upjohn；页面 2023-01 更新；Clinical Pharmacology）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=388e249d-b9b6-44c3-9f8f-880eced0239f", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "Xanax", "generic": "阿普唑仑", "dosageFormClass": "口服片剂（C-IV；0.25 mg、0.5 mg、1 mg、2 mg；有日期公开标签所列；四种准确 100 片瓶装分别建立；不与 XANAX XR 混同）" }, "labelSource": { "id": "src_04e1059d381d67d9", "label": "DailyMed（NLM）：XANAX 阿普唑仑有日期美国公开标签（Pharmacia & Upjohn；页面 2023-01 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=388e249d-b9b6-44c3-9f8f-880eced0239f", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "productRoutes": [ { "source": { "id": "src_04e1059d381d67d9", "label": "DailyMed（NLM）：XANAX 阿普唑仑有日期美国公开标签（Pharmacia & Upjohn；页面 2023-01 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=388e249d-b9b6-44c3-9f8f-880eced0239f", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-23", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_ca630b8f06f82f9b", "label": "FDA：XANAX 2023 美国标签档案（NDA 018276）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/018276s059lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-23", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [ { "id": "fda-2020-benzodiazepine-boxed-warning-alprazolam-xanax-safety-communication", "issuedAt": "2020-09-23", "status": "fda_class_safety_communication", "title": { "zh": "FDA 药物安全通讯：包括阿普唑仑／Xanax 的苯二氮䓬类黑框警告更新", "en": "FDA Drug Safety Communication: Boxed Warning update for benzodiazepines including alprazolam/Xanax" }, "summary": { "zh": "FDA 于 2020-09-23 发布苯二氮䓬类药物安全通讯，产品表明确列出 alprazolam／Xanax 与 Xanax XR。公告要求更新美国黑框警告，以一致说明滥用、误用、成瘾、躯体依赖和戒断反应等风险，并提示与阿片类、酒精或其他中枢神经系统抑制物同用时可能增加严重风险。这是美国、特定日期的类别监管通讯；它不能用来判断某个人是否依赖、是否发生相互作用，或支持自行骤停、加减、轮换、与其他镇静产品同服或替换。请把所有处方药、非处方药、酒精及其他物质列入同一张清单，由开方团队或药师核对；出现呼吸困难、癫痫发作或其他严重不适时应立即使用当地紧急医疗支持。", "en": "On 2020-09-23, FDA issued a benzodiazepine Drug Safety Communication whose product table explicitly lists alprazolam/Xanax and Xanax XR. It required updated U.S. Boxed Warnings to describe risks of abuse, misuse, addiction, physical dependence and withdrawal reactions consistently, and notes that use with opioids, alcohol or other central-nervous-system depressants can increase serious risks. This is a dated U.S. class regulatory communication; it cannot determine whether a person has dependence or an interaction, or support self-directed abrupt stopping, dose changes, alternating, combining with another sedating product or substitution. Put all prescriptions, non-prescription medicines, alcohol and other substances on one list for the prescribing team or pharmacist to review; trouble breathing, seizures or other severe symptoms require immediate local emergency support." }, "source": { "id": "src_7b1f9cb057bf46dc", "label": "FDA：2020-09-23 苯二氮䓬类黑框警告更新药物安全通讯（明确列出 alprazolam／Xanax）", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/fda-requiring-boxed-warning-updated-improve-safe-use-benzodiazepine-drug-class", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "DailyMed 的有日期 XANAX（alprazolam）美国公开标签列有 0.25 mg、0.5 mg、1 mg、2 mg 口服片。本页分别建立四种 100 片瓶装的品牌、通用名、每片标示量、NDC、标签所列外观线索与一手来源核对卡；受管制药品的包装数字、颜色或刻痕不生成个人片数、分割、减量、停用、联用、替代、购买或可售资格结论。", "history": "本页仅对应有日期美国公开标签中的 XANAX 0.25 mg（NDC 0009-0029-01）、0.5 mg（0009-0055-01）、1 mg（0009-0090-01）和 2 mg（0009-0094-01）四种 100 片瓶装面板。标签产品数据存在不同营销结束日期；因此页面不描述任何一项为当前供应、在售或可获得。XANAX XR、其他包装、其他市场或其他阿普唑仑产品不能按名称、颜色、mg 或刻痕并入本档案。", "sourceDocuments": [ { "id": "src_04e1059d381d67d9", "label": "DailyMed（NLM）：XANAX 阿普唑仑有日期美国公开标签（Pharmacia & Upjohn；页面 2023-01 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=388e249d-b9b6-44c3-9f8f-880eced0239f", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, { "id": "src_ca630b8f06f82f9b", "label": "FDA：XANAX 2023 美国标签档案（NDA 018276）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/018276s059lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_5ed30b676fbb9773", "label": "FDA Drugs@FDA 官方检索入口", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_lookup_entry", "documentKind": "regulatory_lookup", "market": "US", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } ], "applicationNumber": "NDA 018276", "approvalTimeline": [ { "date": "1981", "title": { "zh": "FDA 标签所列美国初始批准年份", "en": "Initial U.S. approval year listed in the FDA label" }, "detail": { "zh": "本页链接的 FDA 标签档案列示 Initial U.S. Approval: 1981。该历史定位不等同于当前批准、可得性、持有人或其他市场状态。", "en": "The FDA label archive linked here lists Initial U.S. Approval: 1981. This historical locator is not a conclusion about current approval, availability, holder or another market." }, "source": { "id": "src_ca630b8f06f82f9b", "label": "FDA: XANAX label archive", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/018276s059lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, { "date": "2023", "title": { "zh": "FDA 标签档案版本", "en": "FDA label archive version" }, "detail": { "zh": "本页链接 2023 的 FDA 标签档案作为可复核阅读入口。现行标签、规格、适应症和安全信息必须另行以目标市场当前文件核对。", "en": "This page links the 2023 FDA label archive as a traceable reading entry point. Current labeling, strength, indication and safety information require separate verification against the target market’s current document." }, "source": { "id": "src_ca630b8f06f82f9b", "label": "FDA: XANAX label archive", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/018276s059lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "已链接公开标签档案", "en": "Public label archive linked" }, "detail": { "zh": "仅对应本页所列 FDA 文件。", "en": "Only the FDA document listed on this page is linked." } }, { "market": { "zh": "中国大陆、欧盟、日本", "en": "Mainland China, EU, Japan" }, "status": { "zh": "待逐项建立市场记录", "en": "Market record not established" }, "detail": { "zh": "不从美国标签档案推定当地批准、持有人、规格、供应或可售资格。", "en": "No local approval, holder, strength, supply or sale-eligibility conclusion is inferred from the U.S. label archive." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "标签档案能代表现在的产品信息吗？", "en": "Does a label archive represent current product information?" }, "answer": { "zh": "不能自动代表。档案用于定位来源；需要以目标市场的现行官方标签逐项复核。", "en": "Not automatically. The archive locates a source; each point needs verification against the target market’s current official label." } }, { "question": { "zh": "为什么这里不展示价格或原研/仿制结论？", "en": "Why are price and originator/generic conclusions not shown?" }, "answer": { "zh": "这些结论需要产品、剂型、规格、包装、市场、日期和原始记录分别齐全并经人工审核；单一标签文件不足以支持。", "en": "Those conclusions require separately complete and human-reviewed product, dosage-form, strength, pack, market, date and primary-record fields; one label file is insufficient." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "how-to-read-a-drug-label", "regulatory-sources-first" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/xanax/", "en": "https://origindrug.com/en/drugs/xanax/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "valium", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-09-04", "status": "published_traceable_archive" }, "names": { "brand": "VALIUM", "generic": "地西泮", "aliases": [ "VALIUM", "Valium", "diazepam", "diazepam tablets", "地西泮", "地西泮片", "安定", "NDA 013263", "80725-004-01", "80725-005-01", "80725-006-01", "VALIUM 2", "VALIUM 5", "VALIUM 10" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "精神健康", "sourceArchiveMarket": "美国当前公开标签：VALIUM 2 mg、5 mg、10 mg 三种 100 片瓶装；公开标签不等于目标市场批准、实时供应或购买资格", "dosageFormClass": "VALIUM 地西泮 C-IV 口服片：2 mg、5 mg、10 mg；各为 100 片瓶装", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "1963-11-15（FDA Drugs@FDA 所列美国初始批准日期）", "archiveSponsorText": "Waylis Therapeutics LLC / FDA 与 DailyMed 当前公开监管记录" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [ "diazepam injection", "diazepam rectal gel", "diazepam nasal spray", "VALTOCO", "DIASTAT", "地西泮注射液" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-valium-diazepam-tablet-2mg-100-bottle-ndc-8072500401", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（SPL v11，2026-08-11 生效；标签修订 2024-08）", "en": "Current U.S. DailyMed label (SPL v11, effective 11 Aug 2026; label revised Aug 2024)" }, "dosageForm": { "zh": "VALIUM 地西泮口服片（C-IV）", "en": "VALIUM diazepam oral tablet (C-IV)" }, "route": { "zh": "口服（标签产品身份字段）", "en": "oral (label product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 80725-004-01", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片地西泮 2 mg；100 片瓶装", "en": "Diazepam 2 mg per tablet; 100-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=valium-02.jpg&setid=260e2041-2bb3-482f-850e-b5d47a7bdbe6&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "地西泮", "en": "diazepam" }, "value": 2, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、掰片、减量、停用、联用或换药指令", "en": "labelled amount per tablet; not an individual's tablet count, splitting, tapering, stopping, co-use or switching instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-04", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "白色", "en": "white" }, "shape": { "zh": "圆形、平面、带刻痕与 V 形穿孔、斜切边", "en": "round, flat-faced, scored with V-shaped perforation and beveled edges" }, "imprint": "2 / VALIUM", "scoreStatus": "scored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_c3067e75ac75b479", "label": "DailyMed（NLM）：VALIUM 地西泮当前美国公开标签（Waylis；SPL v11）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=260e2041-2bb3-482f-850e-b5d47a7bdbe6", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-valium-diazepam-tablet-5mg-100-bottle-ndc-8072500501", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（SPL v11，2026-08-11 生效；标签修订 2024-08）", "en": "Current U.S. DailyMed label (SPL v11, effective 11 Aug 2026; label revised Aug 2024)" }, "dosageForm": { "zh": "VALIUM 地西泮口服片（C-IV）", "en": "VALIUM diazepam oral tablet (C-IV)" }, "route": { "zh": "口服（标签产品身份字段）", "en": "oral (label product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 80725-005-01", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片地西泮 5 mg；100 片瓶装", "en": "Diazepam 5 mg per tablet; 100-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=valium-03.jpg&setid=260e2041-2bb3-482f-850e-b5d47a7bdbe6&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "地西泮", "en": "diazepam" }, "value": 5, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、掰片、减量、停用、联用或换药指令", "en": "labelled amount per tablet; not an individual's tablet count, splitting, tapering, stopping, co-use or switching instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-04", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "黄色", "en": "yellow" }, "shape": { "zh": "圆形、平面、带刻痕与 V 形穿孔、斜切边", "en": "round, flat-faced, scored with V-shaped perforation and beveled edges" }, "imprint": "5 / VALIUM", "scoreStatus": "scored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_c3067e75ac75b479", "label": "DailyMed（NLM）：VALIUM 地西泮当前美国公开标签（Waylis；SPL v11）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=260e2041-2bb3-482f-850e-b5d47a7bdbe6", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-valium-diazepam-tablet-10mg-100-bottle-ndc-8072500601", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（SPL v11，2026-08-11 生效；标签修订 2024-08）", "en": "Current U.S. DailyMed label (SPL v11, effective 11 Aug 2026; label revised Aug 2024)" }, "dosageForm": { "zh": "VALIUM 地西泮口服片（C-IV）", "en": "VALIUM diazepam oral tablet (C-IV)" }, "route": { "zh": "口服（标签产品身份字段）", "en": "oral (label product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 80725-006-01", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片地西泮 10 mg；100 片瓶装", "en": "Diazepam 10 mg per tablet; 100-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=valium-04.jpg&setid=260e2041-2bb3-482f-850e-b5d47a7bdbe6&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "地西泮", "en": "diazepam" }, "value": 10, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、掰片、减量、停用、联用或换药指令", "en": "labelled amount per tablet; not an individual's tablet count, splitting, tapering, stopping, co-use or switching instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-04", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "蓝色", "en": "blue" }, "shape": { "zh": "圆形、平面、带刻痕与 V 形穿孔、斜切边", "en": "round, flat-faced, scored with V-shaped perforation and beveled edges" }, "imprint": "10 / VALIUM", "scoreStatus": "scored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_c3067e75ac75b479", "label": "DailyMed（NLM）：VALIUM 地西泮当前美国公开标签（Waylis；SPL v11）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=260e2041-2bb3-482f-850e-b5d47a7bdbe6", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-valium-diazepam-tablet-5mg-100-bottle-ndc-8072500501", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=valium-03.jpg&setid=260e2041-2bb3-482f-850e-b5d47a7bdbe6&type=img", "alt": "VALIUM 地西泮 5 mg、NDC 80725-005-01、100 片瓶装在 DailyMed 当前标签中的展示图", "archiveMarket": "美国", "labelVersion": "DailyMed SPL v11；2026-08-11 生效；标签修订 2024-08", "presentation": "VALIUM 地西泮 5 mg、NDC 80725-005-01、100 片瓶装展示面", "notice": "图片只帮助核对这一准确美国标签产品的商品名、通用名、每片强度、NDC、瓶装数量与外观线索；不用于鉴定真伪，也不代表其他规格、其他地西泮剂型、其他市场、当前库存或任何个人用药方案。", "source": { "id": "src_c3067e75ac75b479", "label": "DailyMed（NLM）：VALIUM 地西泮当前美国公开标签与包装图（SPL v11）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=260e2041-2bb3-482f-850e-b5d47a7bdbe6", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "VALIUM 说明书放大阅读：先防止镇静叠加与突然停用", "en": "VALIUM label reading: prevent additive sedation and abrupt withdrawal first" }, "summary": { "zh": "当前美国标签把阿片类合用、滥用/误用/成瘾、身体依赖与停药反应置于黑框警告。网页只整理核对点，不生成个人开始、加减量、分割或停药方案。", "en": "The current U.S. label places opioid co-use, abuse/misuse/addiction, physical dependence and withdrawal reactions in the boxed warning. This page organises checks; it does not generate an individual start, dose-change, split or stop plan." }, "checks": [ { "zh": "2、5、10 mg 是每片标示强度，100 Tablets 是整瓶片数。片剂的刻痕与 V 形穿孔是准确产品的识别线索，不是网页授权自行掰片、减量或替换。", "en": "The 2, 5 and 10 mg figures are labelled amounts per tablet; 100 Tablets is the bottle count. A score and V-shaped perforation identify an exact product; they are not website permission to split, taper or substitute." }, { "zh": "与阿片类药物合用可导致深度镇静、呼吸抑制、昏迷和死亡；酒精及其他中枢神经抑制药也可能叠加影响。请把处方药、非处方药、酒精使用与全部药盒交给药师或医生共同核对；出现呼吸困难、叫不醒等紧急表现应立即联系当地急救。", "en": "Co-use with opioids can cause profound sedation, respiratory depression, coma and death; alcohol and other CNS depressants may add effects. Have a pharmacist or clinician review prescriptions, OTC products, alcohol use and all packs together. Breathing difficulty or inability to awaken requires immediate local emergency help." }, { "zh": "持续使用可能形成身体依赖；突然停用或快速减量可引发危及生命的停药反应。不要自行骤停，也不要照搬网页或他人的减量表；应由负责治疗的专业人员根据实际情况制定并随访。", "en": "Continued use can produce physical dependence; abrupt discontinuation or rapid dose reduction can cause life-threatening withdrawal reactions. Do not abruptly stop or copy a web or another person's taper; the treating professional must individualise and follow it." }, { "zh": "老年人的消除半衰期可能延长并发生蓄积；嗜睡、共济失调、站立不稳、跌倒与骨折风险需优先核对。老人出现明显困倦、步态或意识变化、跌倒时，应避免驾驶并及时联系药师或医生核对完整药单，而不是自行停药。", "en": "Older adults may have a prolonged elimination half-life and accumulation. Somnolence, ataxia, unsteadiness, falls and fractures require priority review. Marked drowsiness, gait or awareness changes, or a fall requires avoiding driving and timely full-list review, not self-stopping." } ], "source": { "id": "src_c3067e75ac75b479", "label": "DailyMed（NLM）：VALIUM 当前美国公开标签——黑框警告、老年人使用与药物相互作用", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=260e2041-2bb3-482f-850e-b5d47a7bdbe6", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "作用机制阅读：GABA 促进作用不能替代产品与风险核对", "en": "Mechanism reading: GABA facilitation does not replace product and risk checks" }, "summary": { "zh": "标签说明，苯二氮䓬类效应被认为来自对抑制性神经递质 GABA 的促进作用。这是机制解释，不是适应症、个人适用性或换药依据。", "en": "The label states that benzodiazepine effects are thought to arise from facilitation of the inhibitory neurotransmitter GABA. This explains a mechanism; it is not an indication, individual-suitability or switching rule." }, "checks": [ { "zh": "“促进 GABA”不能单独回答某个人是否需要 VALIUM、需要多少或用多久；这些问题必须回到准确诊断、处方、目标市场说明书和专业评估。", "en": "‘Facilitates GABA’ cannot decide whether an individual needs VALIUM, how much or for how long; those questions require the exact diagnosis, prescription, target-market label and professional assessment." }, { "zh": "阿片类与苯二氮䓬类通过不同系统抑制中枢活动，合用时呼吸抑制风险可相加；不能用“机制不同”推导安全同服。", "en": "Opioids and benzodiazepines depress central activity through different systems, and respiratory-depression risk can add; different mechanisms do not prove safe co-use." }, { "zh": "其他苯二氮䓬类药物即使也作用于 GABA-A 相关系统，也不能按商品名、颜色或 mg 与 VALIUM 一比一自行换算、叠加或轮换；网页不把机制说明扩展为常规基因筛查建议。", "en": "Other benzodiazepines may also involve GABA-A-related systems, but brand, colour or milligrams do not permit one-for-one self-conversion, combination or rotation with VALIUM. This mechanism text is not a routine genetic-screening recommendation." } ], "source": { "id": "src_c3067e75ac75b479", "label": "DailyMed（NLM）：VALIUM 当前美国公开标签——临床药理 12.1 作用机制", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=260e2041-2bb3-482f-850e-b5d47a7bdbe6", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "VALIUM", "generic": "地西泮", "dosageFormClass": "VALIUM 地西泮 C-IV 口服片：2 mg、5 mg、10 mg；各为 100 片瓶装" }, "labelSource": { "id": "src_c3067e75ac75b479", "label": "DailyMed（NLM）：VALIUM 地西泮当前美国公开标签（SPL v11；2026-08-11 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=260e2041-2bb3-482f-850e-b5d47a7bdbe6", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" }, "productRoutes": [ { "source": { "id": "src_c3067e75ac75b479", "label": "DailyMed（NLM）：VALIUM 地西泮当前美国公开标签（SPL v11；2026-08-11 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=260e2041-2bb3-482f-850e-b5d47a7bdbe6", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-09-04", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_27b3b9c1cb5996ad", "label": "FDA Drugs@FDA：VALIUM NDA 013263 产品与 RLD/RS 记录", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=013263", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" }, "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-09-04", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_9a07aef31d58508f", "label": "FDA：VALIUM 2024 美国处方信息（NDA 013263）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/013263Orig1s101lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" }, "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-09-04", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-09-04", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "VALIUM 是地西泮口服片的美国品牌监管档案。本页把 2 mg、5 mg、10 mg 三个当前公开标签产品分别绑定到准确 NDC、100 片瓶装、颜色、刻印和一手来源；包装数字、颜色、刻痕和共同的地西泮成分都不能转化为个人片数、掰片、减量、停用、联用或替换方案。", "history": "FDA Drugs@FDA 记录 NDA 013263 于 1963-11-15 首次批准。DailyMed 当前标签（SPL v11，2026-08-11 生效；标签修订 2024-08）由 Waylis Therapeutics LLC 发布，列示 2 mg 白色、5 mg 黄色、10 mg 蓝色圆形片和对应 100 片瓶装。FDA 的 RLD/RS 字段只描述美国监管参照关系；不能据此推定中国或其他国家当前批准、供应、真伪或可替代性。", "sourceDocuments": [ { "id": "src_c3067e75ac75b479", "label": "DailyMed（NLM）：VALIUM 地西泮当前美国公开标签（SPL v11；2026-08-11 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=260e2041-2bb3-482f-850e-b5d47a7bdbe6", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" }, { "id": "src_27b3b9c1cb5996ad", "label": "FDA Drugs@FDA：VALIUM NDA 013263 产品与 RLD/RS 记录", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=013263", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" }, { "id": "src_9a07aef31d58508f", "label": "FDA：VALIUM 2024 美国处方信息（NDA 013263）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/013263Orig1s101lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" } ], "applicationNumber": "FDA NDA 013263（VALIUM；diazepam tablets）", "approvalTimeline": [ { "date": "1963-11-15", "title": { "zh": "FDA 首次批准 VALIUM NDA 013263", "en": "FDA first approved VALIUM NDA 013263" }, "detail": { "zh": "Drugs@FDA 产品记录将 VALIUM、地西泮口服片与该美国初始批准日期相连；这是美国监管历史节点，不代表其他市场批准或今天的供应。", "en": "The Drugs@FDA product record links VALIUM diazepam oral tablets to this initial U.S. approval date. It is a U.S. regulatory-history node, not evidence of another market's approval or today's supply." }, "source": { "id": "src_27b3b9c1cb5996ad", "label": "FDA Drugs@FDA：VALIUM NDA 013263 产品记录与初始批准日期", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=013263", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" } }, { "date": "2026-08-11", "title": { "zh": "当前 DailyMed SPL v11 生效", "en": "Current DailyMed SPL v11 became effective" }, "detail": { "zh": "本页三种准确 100 片瓶装、外观、黑框警告和老年人阅读均以该当前公开标签为主要来源；标签日期不等于渠道库存。", "en": "The three exact 100-tablet bottles, appearance, boxed warning and older-adult reading on this page use this current public label as the primary source. A label date is not channel stock." }, "source": { "id": "src_c3067e75ac75b479", "label": "DailyMed（NLM）：VALIUM 当前美国公开标签（SPL v11）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=260e2041-2bb3-482f-850e-b5d47a7bdbe6", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "NDA 013263 当前公开产品记录与标签已建立", "en": "Current public product record and label established under NDA 013263" }, "detail": { "zh": "2 mg、5 mg、10 mg 均为 RLD；10 mg 另列为 RS。本页分别保存三种 NDC、100 片瓶装与标签图，但不声明任何渠道库存、真伪或个人适用性。", "en": "The 2 mg, 5 mg and 10 mg products are listed as RLDs; 10 mg is also listed as RS. The page preserves each NDC, 100-tablet bottle and label image, but does not claim channel stock, authenticity or individual suitability." } }, { "market": { "zh": "中国大陆、欧盟、日本及其他市场", "en": "Mainland China, EU, Japan and other markets" }, "status": { "zh": "现行品牌、批准、包装和参比关系待逐市场核验", "en": "Current brand, approval, pack and reference status not yet established market by market" }, "detail": { "zh": "不从美国 VALIUM 商品名、NDA、RLD/RS、NDC、颜色或刻痕推定当地批准、供应、原研/参比关系、可售资格或可替代性。", "en": "No local approval, supply, originator/reference status, sale eligibility or interchangeability is inferred from the U.S. VALIUM name, NDA, RLD/RS status, NDC, colour or score." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "药片有刻痕，能自己掰开或减量吗？", "en": "Can a scored tablet be split or reduced without review?" }, "answer": { "zh": "不能从刻痕直接得出结论。刻痕和 V 形穿孔首先是这一准确产品的身份线索；是否可分割、怎样减量或停用必须由负责治疗的专业人员结合实际处方和包装确认。", "en": "A score does not decide this. The score and V-shaped perforation first identify the exact product. A treating professional must use the actual prescription and pack to decide whether it can be divided and how any reduction or stop is handled." } }, { "question": { "zh": "和止痛药或酒一起用安全吗？", "en": "Is it safe with a pain medicine or alcohol?" }, "answer": { "zh": "网页不能给个人联用结论。阿片类止痛药可与 VALIUM 叠加深度镇静和呼吸抑制；酒精及其他中枢抑制药也需一并核对。请把完整药单和酒精使用情况交给药师或医生。", "en": "A webpage cannot decide individual co-use. Opioid pain medicines can add profound sedation and respiratory depression with VALIUM, and alcohol and other CNS depressants also require review. Give the full list and alcohol use to a pharmacist or clinician." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/valium/", "en": "https://origindrug.com/en/drugs/valium/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "klonopin", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-09-04", "status": "published_traceable_archive" }, "names": { "brand": "KLONOPIN", "generic": "氯硝西泮", "aliases": [ "KLONOPIN", "Klonopin", "clonazepam", "clonazepam tablets", "氯硝西泮", "氯硝西泮片", "氯硝安定", "NDA 017533", "61269-605-10", "61269-610-10", "61269-620-10", "KLONOPIN 0.5", "KLONOPIN 1", "KLONOPIN 2" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "精神健康", "sourceArchiveMarket": "美国当前公开标签：KLONOPIN 0.5 mg、1 mg、2 mg 三种 100 片瓶装；公开标签不等于目标市场批准、实时供应或购买资格", "dosageFormClass": "KLONOPIN 氯硝西泮 C-IV 口服片：0.5 mg、1 mg、2 mg；各为 100 片瓶装", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "1975-06-04（FDA Drugs@FDA 所列美国初始批准日期）", "archiveSponsorText": "H2-Pharma / CHEPLAPHARM / FDA 与 DailyMed 当前公开监管记录" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [ "clonazepam orally disintegrating tablets", "KLONOPIN Wafers", "clonazepam injection", "氯硝西泮口崩片", "VALIUM", "XANAX" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-klonopin-clonazepam-tablet-0-5mg-100-bottle-ndc-6126960510", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（2025-12-01 更新；SPL v6）", "en": "Current U.S. DailyMed label (updated 1 Dec 2025; SPL v6)" }, "dosageForm": { "zh": "KLONOPIN 氯硝西泮口服片（C-IV）", "en": "KLONOPIN clonazepam oral tablet (C-IV)" }, "route": { "zh": "口服（标签产品身份字段）", "en": "oral (label product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 61269-605-10", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片氯硝西泮 0.5 mg；100 片瓶装", "en": "Clonazepam 0.5 mg per tablet; 100-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=klonopin-005.jpg&setid=cfa0d79a-843c-4b88-95a1-e9511d649ca1&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "氯硝西泮", "en": "clonazepam" }, "value": 0.5, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、掰片、减量、停用、联用或换药指令", "en": "labelled amount per tablet; not an individual's tablet count, splitting, tapering, stopping, co-use or switching instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-04", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "橙色", "en": "orange" }, "shape": { "zh": "圆形、K 形穿孔、可见二等分刻痕", "en": "round with K-shaped perforation and a two-piece score" }, "imprint": "1/2;KLONOPIN", "scoreStatus": "scored_exact_label_not_universal_self_split_permission", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_088098fd80958691", "label": "DailyMed（NLM）：KLONOPIN 氯硝西泮当前美国公开标签（SPL v6）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=cfa0d79a-843c-4b88-95a1-e9511d649ca1", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-klonopin-clonazepam-tablet-1mg-100-bottle-ndc-6126961010", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（2025-12-01 更新；SPL v6）", "en": "Current U.S. DailyMed label (updated 1 Dec 2025; SPL v6)" }, "dosageForm": { "zh": "KLONOPIN 氯硝西泮口服片（C-IV）", "en": "KLONOPIN clonazepam oral tablet (C-IV)" }, "route": { "zh": "口服（标签产品身份字段）", "en": "oral (label product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 61269-610-10", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片氯硝西泮 1 mg；100 片瓶装", "en": "Clonazepam 1 mg per tablet; 100-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=klonopin-006.jpg&setid=cfa0d79a-843c-4b88-95a1-e9511d649ca1&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "氯硝西泮", "en": "clonazepam" }, "value": 1, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、掰片、减量、停用、联用或换药指令", "en": "labelled amount per tablet; not an individual's tablet count, splitting, tapering, stopping, co-use or switching instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-04", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "蓝色", "en": "blue" }, "shape": { "zh": "圆形、K 形穿孔、无刻痕", "en": "round with K-shaped perforation and no score" }, "imprint": "1;KLONOPIN", "scoreStatus": "not_scored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_088098fd80958691", "label": "DailyMed（NLM）：KLONOPIN 氯硝西泮当前美国公开标签（SPL v6）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=cfa0d79a-843c-4b88-95a1-e9511d649ca1", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-klonopin-clonazepam-tablet-2mg-100-bottle-ndc-6126962010", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（2025-12-01 更新；SPL v6）", "en": "Current U.S. DailyMed label (updated 1 Dec 2025; SPL v6)" }, "dosageForm": { "zh": "KLONOPIN 氯硝西泮口服片（C-IV）", "en": "KLONOPIN clonazepam oral tablet (C-IV)" }, "route": { "zh": "口服（标签产品身份字段）", "en": "oral (label product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 61269-620-10", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片氯硝西泮 2 mg；100 片瓶装", "en": "Clonazepam 2 mg per tablet; 100-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=klonopin-007.jpg&setid=cfa0d79a-843c-4b88-95a1-e9511d649ca1&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "氯硝西泮", "en": "clonazepam" }, "value": 2, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、掰片、减量、停用、联用或换药指令", "en": "labelled amount per tablet; not an individual's tablet count, splitting, tapering, stopping, co-use or switching instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-04", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "白色", "en": "white" }, "shape": { "zh": "圆形、K 形穿孔、无刻痕", "en": "round with K-shaped perforation and no score" }, "imprint": "2;KLONOPIN", "scoreStatus": "not_scored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_088098fd80958691", "label": "DailyMed（NLM）：KLONOPIN 氯硝西泮当前美国公开标签（SPL v6）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=cfa0d79a-843c-4b88-95a1-e9511d649ca1", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-klonopin-clonazepam-tablet-0-5mg-100-bottle-ndc-6126960510", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=klonopin-005.jpg&setid=cfa0d79a-843c-4b88-95a1-e9511d649ca1&type=img", "alt": "KLONOPIN 氯硝西泮 0.5 mg、NDC 61269-605-10、100 片瓶装在 DailyMed 当前标签中的展示图", "archiveMarket": "美国", "labelVersion": "DailyMed 当前公开标签（2025-12-01 更新；SPL v6）", "presentation": "KLONOPIN 氯硝西泮 0.5 mg、NDC 61269-605-10、100 片瓶装展示面", "notice": "图片只帮助核对这一准确美国标签产品的商品名、通用名、每片强度、NDC、瓶装数量与外观线索；不用于鉴定真伪，也不代表其他规格、口崩片、其他氯硝西泮产品、其他市场、当前库存或任何个人用药方案。", "source": { "id": "src_088098fd80958691", "label": "DailyMed（NLM）：KLONOPIN 氯硝西泮当前美国公开标签与包装图（SPL v6）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=cfa0d79a-843c-4b88-95a1-e9511d649ca1", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "KLONOPIN 说明书放大阅读：先防止镇静叠加与突然停用", "en": "KLONOPIN label reading: prevent additive sedation and abrupt withdrawal first" }, "summary": { "zh": "当前标签以黑框警告提醒阿片类合用、滥用/误用/成瘾及身体依赖和停药反应。老人、多药使用者或有呼吸问题的人，应优先核对嗜睡、认知和动作受损、跌倒、呼吸抑制以及全部镇静药；不要自行骤停或照搬网上减量表。", "en": "The current label uses a boxed warning for opioid co-use, abuse/misuse/addiction, physical dependence and withdrawal reactions. Older adults, people using several medicines or those with respiratory problems should prioritise review of somnolence, cognitive and motor impairment, falls, respiratory depression and every sedating medicine; do not abruptly self-stop or copy an online taper." }, "checks": [ { "zh": "0.5、1、2 mg 分别是每片标签含量，100 tablets 是每瓶片数。数字不能相加，也不能从剩余片数或症状自行计算今天吃几片。", "en": "The 0.5, 1 and 2 mg figures are labelled amounts per tablet, while 100 tablets is the bottle count. Do not add these numbers or calculate today's tablet count from remaining tablets or symptoms." }, { "zh": "当前标签要求片剂用水整片吞服。0.5 mg 的刻痕是准确产品线索，不等于任何人都可自行掰半；1 mg 和 2 mg 当前产品为无刻痕片。", "en": "The current label directs swallowing the tablet whole with water. The 0.5 mg score is an exact-product clue, not universal permission to halve it; the current 1 mg and 2 mg products are unscored." }, { "zh": "阿片类、酒精、其他苯二氮䓬类、助眠药、镇静性抗过敏药及其他中枢抑制药可能叠加。标签警示阿片类联用可导致深度镇静、呼吸抑制、昏迷和死亡；明显嗜睡、呼吸变慢、意识异常或叫不醒应立即使用当地急救。", "en": "Opioids, alcohol, other benzodiazepines, sleep medicines, sedating antihistamines and other CNS depressants may add effects. The label warns that opioid co-use can cause profound sedation, respiratory depression, coma and death; marked somnolence, slowed breathing, altered awareness or inability to wake requires local emergency services." }, { "zh": "持续使用可形成身体依赖；突然停用或快速减量可出现危及生命的急性停药反应，包括癫痫发作。减量必须是针对个人的专业方案，不能按 VALIUM、XANAX 或另一种苯二氮䓬药的 mg 一比一换算。", "en": "Continued use can produce physical dependence. Abrupt stopping or rapid reduction can cause life-threatening acute withdrawal reactions, including seizures. Tapering must be individualised by a professional and cannot use one-for-one milligram conversion from VALIUM, XANAX or another benzodiazepine." }, { "zh": "老人更容易出现镇静、混乱、动作和协调受损、跌倒等问题；肝病、肾功能问题、慢阻肺或睡眠呼吸暂停，以及其他抗癫痫药也应在完整药单中优先核对。", "en": "Older adults are more vulnerable to sedation, confusion, impaired movement and coordination, and falls. Liver disease, renal impairment, COPD or sleep apnoea, and other antiseizure medicines also require priority review in the complete medicine list." } ], "source": { "id": "src_088098fd80958691", "label": "DailyMed（NLM）：KLONOPIN 当前美国公开标签——黑框警告、老年人使用、呼吸风险与相互作用", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=cfa0d79a-843c-4b88-95a1-e9511d649ca1", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "KLONOPIN 机制阅读：增强 GABA 活性不等于可以自行换药", "en": "KLONOPIN mechanism reading: enhancing GABA activity does not permit self-switching" }, "summary": { "zh": "当前标签说明其抗癫痫和抗惊恐的确切机制尚不清楚，但认为可能与增强中枢神经系统主要抑制性神经递质 GABA 的活性有关。机制解释不能变成个人选药、剂量、基因检测或联用规则。", "en": "The current label says the precise antiseizure and antipanic mechanisms are unknown, but may relate to enhancing activity of GABA, the major inhibitory neurotransmitter in the CNS. A mechanism description cannot become an individual medicine choice, dose, genetic test or co-use rule." }, "checks": [ { "zh": "“增强 GABA 活性”是药理线索，不能预测某个人会不会嗜睡、跌倒、产生依赖或出现停药反应。", "en": "‘Enhances GABA activity’ is a pharmacology clue and cannot predict an individual's somnolence, falls, dependence or withdrawal reactions." }, { "zh": "KLONOPIN、VALIUM、XANAX 即使同属苯二氮䓬类，也不是可以按商品名、颜色或 mg 一比一换算、叠加或轮换的同一产品。", "en": "KLONOPIN, VALIUM and XANAX may share the benzodiazepine class, but they are not one product that can be converted, combined or rotated one-for-one by brand, colour or milligrams." }, { "zh": "网页不依据机制建议常规全基因筛查。个人适用性仍要结合诊断、呼吸和肝肾情况、完整药单、既往反应与目标市场现行说明书。", "en": "The site does not recommend routine whole-genome screening from this mechanism. Individual suitability still requires diagnosis, respiratory and liver/kidney status, the complete medicine list, prior response and the current target-market label." } ], "source": { "id": "src_088098fd80958691", "label": "DailyMed（NLM）：KLONOPIN 当前美国公开标签——临床药理作用机制", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=cfa0d79a-843c-4b88-95a1-e9511d649ca1", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "KLONOPIN", "generic": "氯硝西泮", "dosageFormClass": "KLONOPIN 氯硝西泮 C-IV 口服片：0.5 mg、1 mg、2 mg；各为 100 片瓶装" }, "labelSource": { "id": "src_088098fd80958691", "label": "DailyMed（NLM）：KLONOPIN 氯硝西泮当前美国公开标签（2025-12-01 更新；SPL v6）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=cfa0d79a-843c-4b88-95a1-e9511d649ca1", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" }, "productRoutes": [ { "source": { "id": "src_088098fd80958691", "label": "DailyMed（NLM）：KLONOPIN 氯硝西泮当前美国公开标签（2025-12-01 更新；SPL v6）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=cfa0d79a-843c-4b88-95a1-e9511d649ca1", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-09-04", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_c226b8c9c6756f9d", "label": "FDA Drugs@FDA：KLONOPIN NDA 017533 产品与 RLD/RS 记录", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=017533", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" }, "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-09-04", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_d4929922ecd19b2e", "label": "FDA：KLONOPIN 2023 美国处方信息（NDA 017533/S-062）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/017533s062lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" }, "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-09-04", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-09-04", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "KLONOPIN 是氯硝西泮口服片的美国品牌监管档案。本页把 0.5 mg、1 mg、2 mg 三个当前公开标签产品分别绑定到准确 NDC、100 片瓶装、颜色、刻印、刻痕状态和一手来源；包装数字、颜色、K 形穿孔或共同的苯二氮䓬类别都不能转化为个人片数、掰片、减量、停用、联用或替换方案。", "history": "FDA Drugs@FDA 记录 NDA 017533 于 1975-06-04 首次批准。DailyMed 当前记录于 2025-12-01 更新，列示 0.5 mg 橙色刻痕片、1 mg 蓝色无刻痕片、2 mg 白色无刻痕片和对应 100 片瓶装。历史 KLONOPIN Wafers 口崩片、其他氯硝西泮产品以及其他市场不能并入这三种当前美国普通片。", "sourceDocuments": [ { "id": "src_088098fd80958691", "label": "DailyMed（NLM）：KLONOPIN 氯硝西泮当前美国公开标签（2025-12-01 更新；SPL v6）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=cfa0d79a-843c-4b88-95a1-e9511d649ca1", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" }, { "id": "src_c226b8c9c6756f9d", "label": "FDA Drugs@FDA：KLONOPIN NDA 017533 产品与 RLD/RS 记录", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=017533", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" }, { "id": "src_d4929922ecd19b2e", "label": "FDA：KLONOPIN 2023 美国处方信息（NDA 017533/S-062）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/017533s062lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" } ], "applicationNumber": "FDA NDA 017533（KLONOPIN；clonazepam tablets）", "approvalTimeline": [ { "date": "1975-06-04", "title": { "zh": "FDA 首次批准 KLONOPIN NDA 017533", "en": "FDA first approved KLONOPIN NDA 017533" }, "detail": { "zh": "Drugs@FDA 将 KLONOPIN 氯硝西泮口服片与该美国首次批准日期相连；这是美国监管历史节点，不代表其他市场批准或今天的供应。", "en": "Drugs@FDA links KLONOPIN clonazepam oral tablets to this initial U.S. approval date. It is a U.S. regulatory-history node, not evidence of another market's approval or today's supply." }, "source": { "id": "src_c226b8c9c6756f9d", "label": "FDA Drugs@FDA：KLONOPIN NDA 017533 产品记录与初始批准日期", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=017533", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" } }, { "date": "2025-12-01", "title": { "zh": "DailyMed 当前公开标签更新", "en": "Current DailyMed public label updated" }, "detail": { "zh": "本页三种准确 100 片瓶装、外观、黑框警告和老人/多药阅读均以该公开标签为主要来源；标签更新时间不等于渠道库存。", "en": "The three exact 100-tablet bottles, appearance, boxed warning and older-adult/polypharmacy reading use this public label as the primary source. A label update date is not channel stock." }, "source": { "id": "src_088098fd80958691", "label": "DailyMed（NLM）：KLONOPIN 当前美国公开标签（SPL v6）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=cfa0d79a-843c-4b88-95a1-e9511d649ca1", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "NDA 017533 当前公开产品记录与标签已建立", "en": "Current public product record and label established under NDA 017533" }, "detail": { "zh": "0.5 mg、1 mg、2 mg 均列为处方 RLD；1 mg 另列为 RS。本页分别保存三种 NDC、100 片瓶装与标签图，但不声明任何渠道库存、真伪或个人适用性。", "en": "The 0.5 mg, 1 mg and 2 mg products are listed as prescription RLDs; 1 mg is also listed as RS. The page preserves each NDC, 100-tablet bottle and label image without claiming channel stock, authenticity or individual suitability." } }, { "market": { "zh": "中国大陆、欧盟、日本及其他市场", "en": "Mainland China, EU, Japan and other markets" }, "status": { "zh": "现行品牌、批准、包装和参比关系待逐市场核验", "en": "Current brand, approval, pack and reference status not yet established market by market" }, "detail": { "zh": "不从美国 KLONOPIN 商品名、NDA、RLD/RS、NDC、颜色或刻痕推定当地批准、供应、原研/参比关系、可售资格或可替代性。", "en": "No local approval, supply, originator/reference status, sale eligibility or interchangeability is inferred from the U.S. KLONOPIN name, NDA, RLD/RS status, NDC, colour or score." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "0.5 mg 有刻痕，能自己掰开或减量吗？", "en": "Can the scored 0.5 mg tablet be self-split or reduced?" }, "answer": { "zh": "不能从刻痕直接得出个人结论。刻痕首先是这一准确产品的身份字段；是否可分割、怎样减量或停用必须由负责治疗的专业人员结合实际处方和包装制定。1 mg 与 2 mg 当前标签明确为无刻痕片。", "en": "A score does not decide an individual's plan. It first identifies the exact product. A treating professional must use the actual prescription and pack to decide whether division is appropriate and how reduction or stopping is handled. The current 1 mg and 2 mg tablets are unscored." } }, { "question": { "zh": "能和 VALIUM、XANAX、阿片止痛药或酒一起用吗？", "en": "Can it be used with VALIUM, XANAX, an opioid or alcohol?" }, "answer": { "zh": "网页不能决定个人联用。共同镇静作用可能叠加；KLONOPIN 与阿片类合用可造成深度镇静、呼吸抑制、昏迷和死亡。酒精、其他苯二氮䓬类和所有中枢抑制药都应随完整药单交给药师或医生核对。", "en": "A webpage cannot decide individual co-use. Sedating effects may add, and KLONOPIN with opioids can cause profound sedation, respiratory depression, coma and death. Alcohol, other benzodiazepines and all CNS depressants should be reviewed with the complete medicine list by a pharmacist or clinician." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/klonopin/", "en": "https://origindrug.com/en/drugs/klonopin/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "seroquel", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-23", "status": "published_traceable_archive" }, "names": { "brand": "Seroquel", "generic": "喹硫平", "aliases": [ "SEROQUEL", "quetiapine", "喹硫平", "思瑞康", "富马酸喹硫平", "富马酸喹硫平片" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": { "value": "思瑞康®", "status": "discovery_cue_requires_target_market_verification", "source": { "id": "src_f9f3fc5849987c8c", "label": "铜陵市卫生健康委员会：公开药品信息中的思瑞康／富马酸喹硫平片记录", "url": "https://wsjkw.tl.gov.cn/tlswsjkwyh/c00049/pc/content/content_1686682871854325760.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "government_medicine_listing", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-12", "reviewedAt": "2026-09-12" } } }, "identity": { "therapeuticArea": "精神健康", "sourceArchiveMarket": "美国 SEROQUEL 喹硫平普通口服薄膜衣片公开标签（DailyMed：2025-01-22 更新；本页分别核对 25/50/100/200/400 mg 的 100 片瓶装与 300 mg 的 60 片瓶装）", "dosageFormClass": "普通口服薄膜衣片：25 mg、50 mg、100 mg、200 mg、300 mg、400 mg（美国公开标签所列；六种准确瓶装分别建立）；不与 SEROQUEL XR 缓释片混同", "dosageFormClassCode": "oral_modified_release", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "1997（当前美国标签所列 Initial U.S. Approval）", "archiveSponsorText": "AstraZeneca Pharmaceuticals LP / DailyMed（NLM）当前公开标签档案" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [ "SEROQUEL XR", "quetiapine extended release", "quetiapine XR", "喹硫平缓释", "喹硫平 XR" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-seroquel-quetiapine-immediate-tablet-25mg-100-bottle-ndc-0310027510", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（页面 2025-01-22 更新）；仅为所引公开标签展示面，不代表供应", "en": "Current U.S. DailyMed public label (page updated 22 Jan 2025); cited public label panel only, not availability" }, "dosageForm": { "zh": "SEROQUEL 喹硫平普通口服薄膜衣片（非 XR 缓释片）", "en": "SEROQUEL quetiapine immediate film-coated oral tablet (not XR extended-release tablet)" }, "route": { "zh": "口服（标签产品身份字段）", "en": "oral (label product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 0310-0275-10", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片喹硫平 25 mg；100 片瓶装", "en": "Quetiapine 25 mg per tablet; 100-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=NDC0310-0275-10.jpg&setid=0584dda8-bc3c-48fe-1a90-79608f78e8a0&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "喹硫平", "en": "quetiapine" }, "value": 25, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、分割、转换、停用、联用或换药指令", "en": "labelled amount per tablet; not an individual's tablet count, splitting, conversion, stopping, co-use or switching instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-23", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "桃色", "en": "peach" }, "shape": { "zh": "圆形双凸薄膜衣片；无刻痕", "en": "round biconvex film-coated tablet; no score" }, "imprint": "SEROQUEL / 25", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_429830ad419b5719", "label": "DailyMed（NLM）：SEROQUEL 喹硫平普通口服片当前美国公开标签（AstraZeneca；页面 2025-01-22 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=0584dda8-bc3c-48fe-1a90-79608f78e8a0", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-seroquel-quetiapine-immediate-tablet-50mg-100-bottle-ndc-0310027810", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（页面 2025-01-22 更新）；仅为所引公开标签展示面，不代表供应", "en": "Current U.S. DailyMed public label (page updated 22 Jan 2025); cited public label panel only, not availability" }, "dosageForm": { "zh": "SEROQUEL 喹硫平普通口服薄膜衣片（非 XR 缓释片）", "en": "SEROQUEL quetiapine immediate film-coated oral tablet (not XR extended-release tablet)" }, "route": { "zh": "口服（标签产品身份字段）", "en": "oral (label product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 0310-0278-10", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片喹硫平 50 mg；100 片瓶装", "en": "Quetiapine 50 mg per tablet; 100-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=NDC0310-0278-10.jpg&setid=0584dda8-bc3c-48fe-1a90-79608f78e8a0&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "喹硫平", "en": "quetiapine" }, "value": 50, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、分割、转换、停用、联用或换药指令", "en": "labelled amount per tablet; not an individual's tablet count, splitting, conversion, stopping, co-use or switching instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-23", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "白色", "en": "white" }, "shape": { "zh": "圆形双凸薄膜衣片；无刻痕", "en": "round biconvex film-coated tablet; no score" }, "imprint": "SEROQUEL / 50", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_429830ad419b5719", "label": "DailyMed（NLM）：SEROQUEL 喹硫平普通口服片当前美国公开标签（AstraZeneca；页面 2025-01-22 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=0584dda8-bc3c-48fe-1a90-79608f78e8a0", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-seroquel-quetiapine-immediate-tablet-100mg-100-bottle-ndc-0310027110", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（页面 2025-01-22 更新）；仅为所引公开标签展示面，不代表供应", "en": "Current U.S. DailyMed public label (page updated 22 Jan 2025); cited public label panel only, not availability" }, "dosageForm": { "zh": "SEROQUEL 喹硫平普通口服薄膜衣片（非 XR 缓释片）", "en": "SEROQUEL quetiapine immediate film-coated oral tablet (not XR extended-release tablet)" }, "route": { "zh": "口服（标签产品身份字段）", "en": "oral (label product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 0310-0271-10", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片喹硫平 100 mg；100 片瓶装", "en": "Quetiapine 100 mg per tablet; 100-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=NDC0310-0271-10.jpg&setid=0584dda8-bc3c-48fe-1a90-79608f78e8a0&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "喹硫平", "en": "quetiapine" }, "value": 100, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、分割、转换、停用、联用或换药指令", "en": "labelled amount per tablet; not an individual's tablet count, splitting, conversion, stopping, co-use or switching instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-23", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "黄色", "en": "yellow" }, "shape": { "zh": "圆形双凸薄膜衣片；无刻痕", "en": "round biconvex film-coated tablet; no score" }, "imprint": "SEROQUEL / 100", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_429830ad419b5719", "label": "DailyMed（NLM）：SEROQUEL 喹硫平普通口服片当前美国公开标签（AstraZeneca；页面 2025-01-22 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=0584dda8-bc3c-48fe-1a90-79608f78e8a0", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-seroquel-quetiapine-immediate-tablet-200mg-100-bottle-ndc-0310027210", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（页面 2025-01-22 更新）；仅为所引公开标签展示面，不代表供应", "en": "Current U.S. DailyMed public label (page updated 22 Jan 2025); cited public label panel only, not availability" }, "dosageForm": { "zh": "SEROQUEL 喹硫平普通口服薄膜衣片（非 XR 缓释片）", "en": "SEROQUEL quetiapine immediate film-coated oral tablet (not XR extended-release tablet)" }, "route": { "zh": "口服（标签产品身份字段）", "en": "oral (label product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 0310-0272-10", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片喹硫平 200 mg；100 片瓶装", "en": "Quetiapine 200 mg per tablet; 100-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=NDC0310-0272-10.jpg&setid=0584dda8-bc3c-48fe-1a90-79608f78e8a0&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "喹硫平", "en": "quetiapine" }, "value": 200, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、分割、转换、停用、联用或换药指令", "en": "labelled amount per tablet; not an individual's tablet count, splitting, conversion, stopping, co-use or switching instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-23", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "白色", "en": "white" }, "shape": { "zh": "圆形双凸薄膜衣片；无刻痕", "en": "round biconvex film-coated tablet; no score" }, "imprint": "SEROQUEL / 200", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_429830ad419b5719", "label": "DailyMed（NLM）：SEROQUEL 喹硫平普通口服片当前美国公开标签（AstraZeneca；页面 2025-01-22 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=0584dda8-bc3c-48fe-1a90-79608f78e8a0", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-seroquel-quetiapine-immediate-tablet-300mg-60-bottle-ndc-0310027460", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（页面 2025-01-22 更新）；仅为所引公开标签展示面，不代表供应", "en": "Current U.S. DailyMed public label (page updated 22 Jan 2025); cited public label panel only, not availability" }, "dosageForm": { "zh": "SEROQUEL 喹硫平普通口服薄膜衣片（非 XR 缓释片）", "en": "SEROQUEL quetiapine immediate film-coated oral tablet (not XR extended-release tablet)" }, "route": { "zh": "口服（标签产品身份字段）", "en": "oral (label product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 0310-0274-60", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片喹硫平 300 mg；60 片瓶装", "en": "Quetiapine 300 mg per tablet; 60-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=NDC0310-0274-60.jpg&setid=0584dda8-bc3c-48fe-1a90-79608f78e8a0&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "喹硫平", "en": "quetiapine" }, "value": 300, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、分割、转换、停用、联用或换药指令", "en": "labelled amount per tablet; not an individual's tablet count, splitting, conversion, stopping, co-use or switching instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 60, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-23", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 60, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "白色", "en": "white" }, "shape": { "zh": "胶囊形双凸薄膜衣片；无刻痕", "en": "capsule-shaped biconvex film-coated tablet; no score" }, "imprint": "SEROQUEL / 300", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_429830ad419b5719", "label": "DailyMed（NLM）：SEROQUEL 喹硫平普通口服片当前美国公开标签（AstraZeneca；页面 2025-01-22 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=0584dda8-bc3c-48fe-1a90-79608f78e8a0", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-seroquel-quetiapine-immediate-tablet-400mg-100-bottle-ndc-0310027910", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（页面 2025-01-22 更新）；仅为所引公开标签展示面，不代表供应", "en": "Current U.S. DailyMed public label (page updated 22 Jan 2025); cited public label panel only, not availability" }, "dosageForm": { "zh": "SEROQUEL 喹硫平普通口服薄膜衣片（非 XR 缓释片）", "en": "SEROQUEL quetiapine immediate film-coated oral tablet (not XR extended-release tablet)" }, "route": { "zh": "口服（标签产品身份字段）", "en": "oral (label product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 0310-0279-10", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片喹硫平 400 mg；100 片瓶装", "en": "Quetiapine 400 mg per tablet; 100-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=NDC0310-0279-10.jpg&setid=0584dda8-bc3c-48fe-1a90-79608f78e8a0&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "喹硫平", "en": "quetiapine" }, "value": 400, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、分割、转换、停用、联用或换药指令", "en": "labelled amount per tablet; not an individual's tablet count, splitting, conversion, stopping, co-use or switching instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-23", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "黄色", "en": "yellow" }, "shape": { "zh": "胶囊形双凸薄膜衣片；无刻痕", "en": "capsule-shaped biconvex film-coated tablet; no score" }, "imprint": "SEROQUEL / 400", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_429830ad419b5719", "label": "DailyMed（NLM）：SEROQUEL 喹硫平普通口服片当前美国公开标签（AstraZeneca；页面 2025-01-22 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=0584dda8-bc3c-48fe-1a90-79608f78e8a0", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-seroquel-quetiapine-immediate-tablet-100mg-100-bottle-ndc-0310027110", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=NDC0310-0271-10.jpg&setid=0584dda8-bc3c-48fe-1a90-79608f78e8a0", "alt": "SEROQUEL 喹硫平在美国 DailyMed 公开标签中的 100 mg、NDC 0310-0271-10、100 片瓶装展示面", "archiveMarket": "美国", "labelVersion": "DailyMed 公开标签（2025-01-22 更新）", "presentation": "SEROQUEL 喹硫平普通薄膜衣片：每片 100 mg；NDC 0310-0271-10；100 片瓶装展示面。另有五种独立准确瓶装卡片，不能相互替代。", "notice": "此图只对应美国公开标签中的 SEROQUEL 普通薄膜衣片 100 mg、NDC 0310-0271-10、100 片瓶装。页面另分开列出 25/50/200/400 mg 的 100 片瓶装及 300 mg 的 60 片瓶装；每一张卡都只对应其自身 NDC、强度与包装。它不代表 SEROQUEL XR 缓释片、其他包装、其他市场或其他喹硫平产品；不用于鉴定真伪，也不生成个人片数、时间表、分片、联用、转换或停药方案。", "source": { "id": "src_429830ad419b5719", "label": "DailyMed（NLM）：SEROQUEL 喹硫平普通口服片当前美国公开标签（AstraZeneca，2025-01-22 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=0584dda8-bc3c-48fe-1a90-79608f78e8a0", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "SEROQUEL 说明书放大阅读：普通片、XR 缓释片与 mg 必须分开核对", "en": "SEROQUEL label reading: keep immediate tablets, XR tablets and mg markings separate" }, "summary": { "zh": "本模块以美国公开标签为阅读入口，帮助核对 SEROQUEL、喹硫平、普通薄膜衣片、每片标示强度、准确包装与目标市场；不提供个人片数、时间表、漏用补救、联用、换药或停药建议。", "en": "This module uses the U.S. public label to check SEROQUEL, quetiapine, immediate tablets, stated strength per tablet, the exact pack and target market; it provides no individual tablet count, schedule, missed-use remedy, co-use, switching or stopping advice." }, "checks": [ { "zh": "25、50、100、200、300、400 mg 是当前标签所列普通片的每片标示强度，不是“今天应服几片”的答案。页面把 25/50/100/200/400 mg 的 100 片瓶装和 300 mg 的 60 片瓶装分开列出；名称或 mg 相同都不能证明另一盒是同一产品或可自行转换。", "en": "25, 50, 100, 200, 300 and 400 mg are stated amounts per immediate tablet in the current label, not an answer to 'how many tablets today.' This page lists 100-tablet bottles for 25/50/100/200/400 mg separately from the 60-tablet bottle for 300 mg; a matching name or mg marking does not establish that another pack is the same product or can be self-converted." }, { "zh": "SEROQUEL XR 是缓释片，属于不同产品呈现。不要因同为喹硫平、同属 SEROQUEL 品牌或看到相近 mg 数字，就自行把普通片改成 XR、把 XR 改回普通片、叠加、隔天轮换或按经验掰开；应由开方团队或药师核对实际处方与现行标签。", "en": "SEROQUEL XR is an extended-release tablet and a different product presentation. Do not self-change immediate tablets to XR, change XR back to immediate tablets, combine, alternate days or split from experience merely because both contain quetiapine, share the SEROQUEL name or have similar mg markings; have the actual prescription and current label reviewed by the prescribing team or pharmacist." }, { "zh": "美国标签对痴呆相关精神病老年患者列有重要限制：SEROQUEL 不获批用于这一人群。此处是标签阅读提示，不是网页对任何人的诊断或治疗结论；高龄、认知变化、跌倒、晕厥、嗜睡或多药并用时，应尽快让当地医疗团队核对全部药物和实际药盒。", "en": "The U.S. label carries an important limitation for elderly people with dementia-related psychosis: SEROQUEL is not approved for that population. This is a label-reading prompt, not a web diagnosis or treatment conclusion for any person; with older age, cognitive change, falls, fainting, drowsiness or multiple medicines, ask the local care team to review every medicine and actual pack promptly." }, { "zh": "标签包含嗜睡、头晕/体位性低血压、代谢变化以及与其他中枢作用产品、酒精或其他药物共同使用时的核对事项。不要从网页自行开始、停用、加减、与镇静产品叠加或把不适归因于某一盒药；携带完整药单请医生或药师判断。", "en": "The label includes drowsiness, dizziness/orthostatic hypotension, metabolic changes and review considerations with other centrally acting products, alcohol or other medicines. Do not self-start, stop, adjust, add a sedating product or assign a symptom to one pack from this page; take the complete medicine list to a clinician or pharmacist for assessment." }, { "zh": "出现昏厥、跌倒伴受伤、明显意识或行为改变、严重过敏样反应、持续高热伴肌强直、心悸/胸部不适或其他急性严重问题时，应及时使用当地紧急医疗支持，而不是依据网页自行暂停、恢复或换用另一种精神科药物。", "en": "With fainting, a fall with injury, marked mental or behavioural change, a severe allergy-like reaction, persistent fever with muscle rigidity, palpitations/chest discomfort or another acute serious concern, use local urgent medical support promptly rather than self-pausing, restarting or changing to another psychiatric medicine from a webpage." } ], "source": { "id": "src_429830ad419b5719", "label": "DailyMed（NLM）：SEROQUEL 喹硫平普通口服片当前美国公开标签（AstraZeneca，2025-01-22 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=0584dda8-bc3c-48fe-1a90-79608f78e8a0", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "喹硫平怎样起作用：受体作用说明不能代替个人治疗判断", "en": "How quetiapine works: a receptor explanation does not replace individual treatment judgement" }, "summary": { "zh": "美国标签将喹硫平的作用与多种神经递质受体的拮抗作用联系起来，其中对血清素 5HT2 受体的拮抗强于对多巴胺 D2 受体的拮抗。该说明帮助理解标签中的药理描述，不预测个人症状、适用性、疗效、片数、睡眠安排或能否与其他药物联用。", "en": "The U.S. label relates quetiapine's activity to antagonism at multiple neurotransmitter receptors, with greater antagonism at serotonin 5HT2 than dopamine D2 receptors. This helps read the pharmacology description; it does not predict individual symptoms, suitability, benefit, tablet count, sleep timing or co-use with another medicine." }, "checks": [ { "zh": "“作用于 5HT2、D2 等受体”描述的是药理路径，不是从失眠、情绪、幻觉、焦虑、行为变化或一次体验自行判断是否需要、适合或应改变治疗的工具。", "en": "'Acts at 5HT2, D2 and other receptors' describes a pharmacologic pathway, not a tool for deciding a need, suitability or treatment change from insomnia, mood, hallucinations, anxiety, behavioural change or one experience." }, { "zh": "同样影响神经递质、都被称为抗精神病药，或都可能使人困倦，都不表示可以自行叠加、替换、轮换或由一种产品换算到另一种。品牌、准确剂型、释放方式、既往反应、身体状况和完整药单都必须由专业人员逐项核对。", "en": "A related neurotransmitter effect, antipsychotic class or shared potential for drowsiness does not permit self-combination, replacement, alternation or conversion from one product to another. Brand, exact form, release characteristics, prior reactions, health context and the complete medicine list all need item-by-item professional review." }, { "zh": "机制文字不能处理突发的严重嗜睡、昏厥、跌倒、发热伴肌强直、胸部不适或明显行为改变。出现急性或严重担忧时，应优先使用当地医疗和紧急支持。", "en": "A mechanism explanation cannot manage sudden severe drowsiness, fainting, a fall, fever with muscle rigidity, chest discomfort or marked behavioural change. With an acute or serious concern, prioritise local medical and emergency support." } ], "source": { "id": "src_429830ad419b5719", "label": "DailyMed（NLM）：SEROQUEL 喹硫平普通口服片当前美国公开标签（AstraZeneca，2025-01-22 更新；Clinical Pharmacology）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=0584dda8-bc3c-48fe-1a90-79608f78e8a0", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "Seroquel", "generic": "喹硫平", "dosageFormClass": "普通口服薄膜衣片：25 mg、50 mg、100 mg、200 mg、300 mg、400 mg（美国公开标签所列；六种准确瓶装分别建立）；不与 SEROQUEL XR 缓释片混同" }, "labelSource": { "id": "src_429830ad419b5719", "label": "DailyMed（NLM）：SEROQUEL 喹硫平普通口服片当前美国公开标签（AstraZeneca，2025-01-22 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=0584dda8-bc3c-48fe-1a90-79608f78e8a0", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "productRoutes": [ { "source": { "id": "src_429830ad419b5719", "label": "DailyMed（NLM）：SEROQUEL 喹硫平普通口服片当前美国公开标签（AstraZeneca，2025-01-22 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=0584dda8-bc3c-48fe-1a90-79608f78e8a0", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-23", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-23", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "DailyMed 的 SEROQUEL（quetiapine）美国公开标签列出普通口服薄膜衣片。页面帮助核对品牌、通用名、普通片或缓释片、每片标示强度、实际包装、标签版本与目标市场；不把任何 mg 数字转成个人片数、服用时间、漏用处理、联用、转换或停药方案。", "history": "当前公开标签列示 Initial U.S. Approval: 1997，并由 AstraZeneca Pharmaceuticals LP 作为包装方。SEROQUEL XR 是另一份缓释片标签；共享喹硫平成分、品牌家族或相近 mg 数字，不能证明两种制剂可自行替换、合并、轮换或按经验掰分。", "sourceDocuments": [ { "id": "src_429830ad419b5719", "label": "DailyMed（NLM）：SEROQUEL 喹硫平普通口服片当前美国公开标签（AstraZeneca，2025-01-22 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=0584dda8-bc3c-48fe-1a90-79608f78e8a0", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" } ], "applicationNumber": "NDA 020639", "approvalTimeline": [ { "date": "1997", "title": { "zh": "当前标签所列美国初始批准年份", "en": "Initial U.S. approval year listed in the current label" }, "detail": { "zh": "当前 SEROQUEL 标签列示 Initial U.S. Approval: 1997。该年份仅定位这一美国档案，不建立其他市场的批准、供应或可售状态。", "en": "The current SEROQUEL label lists Initial U.S. Approval: 1997. This year locates this U.S. archive only; it does not establish approval, supply or sale status in another market." }, "source": { "id": "src_429830ad419b5719", "label": "DailyMed（NLM）：SEROQUEL 喹硫平普通口服片当前美国公开标签（AstraZeneca，2025-01-22 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=0584dda8-bc3c-48fe-1a90-79608f78e8a0", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" } }, { "date": "2025-01-22", "title": { "zh": "DailyMed 当前公开标签更新", "en": "Current DailyMed public-label update" }, "detail": { "zh": "DailyMed 页面将 SEROQUEL 普通口服片标为 2025-01-22 更新，包装方为 AstraZeneca Pharmaceuticals LP。该公开记录只支持本页的标签阅读与包装身份核对，不说明个人用药、实际库存或其他市场状态。", "en": "DailyMed marks the SEROQUEL immediate-tablet page updated on 22 Jan 2025 and identifies AstraZeneca Pharmaceuticals LP as packager. This public record supports label reading and package identity on this page only, not individual use, actual stock or another-market status." }, "source": { "id": "src_429830ad419b5719", "label": "DailyMed（NLM）：SEROQUEL 喹硫平普通口服片当前美国公开标签（AstraZeneca，2025-01-22 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=0584dda8-bc3c-48fe-1a90-79608f78e8a0", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "已链接普通片公开标签与六种准确瓶装面板", "en": "Immediate-tablet public label and six exact bottle panels linked" }, "detail": { "zh": "页面分别记录 NDC 0310-0275-10（25 mg，100 片）、0310-0278-10（50 mg，100 片）、0310-0271-10（100 mg，100 片）、0310-0272-10（200 mg，100 片）、0310-0274-60（300 mg，60 片）和 0310-0279-10（400 mg，100 片）。这些身份卡不建立实际在售、库存、个人片数、分片、联用或相互替代关系。", "en": "The page separately records NDC 0310-0275-10 (25 mg, 100 tablets), 0310-0278-10 (50 mg, 100 tablets), 0310-0271-10 (100 mg, 100 tablets), 0310-0272-10 (200 mg, 100 tablets), 0310-0274-60 (300 mg, 60 tablets), and 0310-0279-10 (400 mg, 100 tablets). These identity cards do not establish actual availability, stock, individual tablet count, splitting, co-use or interchangeability." } }, { "market": { "zh": "美国 SEROQUEL XR 与中国大陆、欧盟、日本及其他市场", "en": "U.S. SEROQUEL XR and Mainland China, EU, Japan and other markets" }, "status": { "zh": "明确分开或待逐项建立市场记录", "en": "Explicitly separate or market record not established" }, "detail": { "zh": "SEROQUEL XR 缓释片是不同产品呈现；不从本页普通片标签推定 XR 或任何其他市场的商品名、批准、规格、包装、供应、可售资格、原研/仿制关系或可替代性。", "en": "SEROQUEL XR extended-release tablets are a different product presentation. This immediate-tablet label does not establish a trade name, approval, strength, pack, supply, sale eligibility, originator/generic relationship or interchangeability for XR or any other market." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "SEROQUEL 与 SEROQUEL XR 只有释放方式不同吗？", "en": "Do SEROQUEL and SEROQUEL XR differ only by release?" }, "answer": { "zh": "本页只建立普通薄膜衣片的美国公开标签阅读路径；XR 是另一个缓释片产品呈现。不能由共同成分、品牌家族或相近 mg 数字自行推导两者可换、可合并、可轮换或可按比例拆分。应由药师或开方团队核对实际处方、完整药单与目标市场的现行标签。", "en": "This page establishes the U.S. public-label reading path for immediate film-coated tablets only; XR is a separate extended-release presentation. A shared ingredient, brand family or similar mg marking cannot establish self-substitution, co-use, alternation or proportional splitting. A pharmacist or prescribing team must review the actual prescription, complete medicine list and current target-market label." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/seroquel/", "en": "https://origindrug.com/en/drugs/seroquel/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "zyprexa", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-23", "status": "published_traceable_archive" }, "names": { "brand": "Zyprexa", "generic": "奥氮平", "aliases": [ "ZYPREXA", "olanzapine", "奥氮平" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "精神健康", "sourceArchiveMarket": "美国 ZYPREXA 奥氮平普通口服片公开标签（DailyMed SPL v68，2026-02-16 发布；本档案分别建立六种准确 30 片瓶装身份；不代表供应）", "dosageFormClass": "普通口服片：2.5 mg、5 mg、7.5 mg、10 mg、15 mg、20 mg（美国公开标签所列；本档案分别建立六种 30 片瓶装身份；不与 ZYDIS 口崩片或注射剂合并）", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "1996（当前美国标签所列 Initial U.S. Approval）", "archiveSponsorText": "H2-Pharma LLC / CHEPLAPHARM / DailyMed（NLM）当前公开标签档案" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [ "ZYPREXA ZYDIS", "olanzapine orally disintegrating", "奥氮平口崩", "ZYPREXA INTRAMUSCULAR", "olanzapine injection", "奥氮平注射", "ZYPREXA RELPREVV", "olanzapine pamoate" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-zyprexa-olanzapine-regular-tablet-2-5mg-30-bottle-ndc-6126963030", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（SPL v68，2026-02-16 发布；标签修订 2026-01）；仅为所引公开标签展示面，不代表供应", "en": "Current U.S. DailyMed public label (SPL v68, published 16 Feb 2026; label revised Jan 2026); cited public-label panel only, not availability" }, "dosageForm": { "zh": "ZYPREXA 奥氮平普通口服片（非 ZYDIS 口崩片或注射剂）", "en": "ZYPREXA olanzapine regular oral tablet (not ZYDIS orally disintegrating tablet or injection)" }, "route": { "zh": "口服（标签产品身份字段）", "en": "oral (label product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 61269-630-30", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片奥氮平 2.5 mg；30 片瓶装", "en": "Olanzapine 2.5 mg per tablet; 30-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=zyprexa-02.jpg&setid=b418946a-1ab4-4d89-a012-d94fc361a3c4&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "奥氮平", "en": "olanzapine" }, "value": 2.5, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、分割、联用、停用或换药指令", "en": "labelled amount per tablet; not an individual's tablet count, splitting, co-use, stopping or switching instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-23", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 30, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "白色", "en": "white" }, "shape": { "zh": "圆形片；无刻痕", "en": "round tablet; no score" }, "imprint": "LILLY / 4112", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_80a421981d60495c", "label": "DailyMed（NLM）：ZYPREXA 奥氮平普通片、ZYDIS 口崩片及肌内注射剂当前美国公开标签（H2-Pharma LLC；SPL v68，2026-02-16 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b418946a-1ab4-4d89-a012-d94fc361a3c4", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-zyprexa-olanzapine-regular-tablet-5mg-30-bottle-ndc-6126963130", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（SPL v68，2026-02-16 发布；标签修订 2026-01）；仅为所引公开标签展示面，不代表供应", "en": "Current U.S. DailyMed public label (SPL v68, published 16 Feb 2026; label revised Jan 2026); cited public-label panel only, not availability" }, "dosageForm": { "zh": "ZYPREXA 奥氮平普通口服片（非 ZYDIS 口崩片或注射剂）", "en": "ZYPREXA olanzapine regular oral tablet (not ZYDIS orally disintegrating tablet or injection)" }, "route": { "zh": "口服（标签产品身份字段）", "en": "oral (label product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 61269-631-30", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片奥氮平 5 mg；30 片瓶装", "en": "Olanzapine 5 mg per tablet; 30-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=zyprexa-03.jpg&setid=b418946a-1ab4-4d89-a012-d94fc361a3c4&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "奥氮平", "en": "olanzapine" }, "value": 5, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、分割、联用、停用或换药指令", "en": "labelled amount per tablet; not an individual's tablet count, splitting, co-use, stopping or switching instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-23", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 30, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "白色", "en": "white" }, "shape": { "zh": "圆形片；无刻痕", "en": "round tablet; no score" }, "imprint": "LILLY / 4115", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_80a421981d60495c", "label": "DailyMed（NLM）：ZYPREXA 奥氮平普通片、ZYDIS 口崩片及肌内注射剂当前美国公开标签（H2-Pharma LLC；SPL v68，2026-02-16 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b418946a-1ab4-4d89-a012-d94fc361a3c4", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-zyprexa-olanzapine-regular-tablet-7-5mg-30-bottle-ndc-6126963230", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（SPL v68，2026-02-16 发布；标签修订 2026-01）；仅为所引公开标签展示面，不代表供应", "en": "Current U.S. DailyMed public label (SPL v68, published 16 Feb 2026; label revised Jan 2026); cited public-label panel only, not availability" }, "dosageForm": { "zh": "ZYPREXA 奥氮平普通口服片（非 ZYDIS 口崩片或注射剂）", "en": "ZYPREXA olanzapine regular oral tablet (not ZYDIS orally disintegrating tablet or injection)" }, "route": { "zh": "口服（标签产品身份字段）", "en": "oral (label product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 61269-632-30", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片奥氮平 7.5 mg；30 片瓶装", "en": "Olanzapine 7.5 mg per tablet; 30-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=zyprexa-04.jpg&setid=b418946a-1ab4-4d89-a012-d94fc361a3c4&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "奥氮平", "en": "olanzapine" }, "value": 7.5, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、分割、联用、停用或换药指令", "en": "labelled amount per tablet; not an individual's tablet count, splitting, co-use, stopping or switching instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-23", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 30, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "白色", "en": "white" }, "shape": { "zh": "圆形片；无刻痕", "en": "round tablet; no score" }, "imprint": "LILLY / 4116", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_80a421981d60495c", "label": "DailyMed（NLM）：ZYPREXA 奥氮平普通片、ZYDIS 口崩片及肌内注射剂当前美国公开标签（H2-Pharma LLC；SPL v68，2026-02-16 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b418946a-1ab4-4d89-a012-d94fc361a3c4", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-zyprexa-olanzapine-regular-tablet-10mg-30-bottle-ndc-6126963330", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（SPL v68，2026-02-16 发布；标签修订 2026-01）；仅为所引公开标签展示面，不代表供应", "en": "Current U.S. DailyMed public label (SPL v68, published 16 Feb 2026; label revised Jan 2026); cited public-label panel only, not availability" }, "dosageForm": { "zh": "ZYPREXA 奥氮平普通口服片（非 ZYDIS 口崩片或注射剂）", "en": "ZYPREXA olanzapine regular oral tablet (not ZYDIS orally disintegrating tablet or injection)" }, "route": { "zh": "口服（标签产品身份字段）", "en": "oral (label product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 61269-633-30", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片奥氮平 10 mg；30 片瓶装", "en": "Olanzapine 10 mg per tablet; 30-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=zyprexa-05.jpg&setid=b418946a-1ab4-4d89-a012-d94fc361a3c4&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "奥氮平", "en": "olanzapine" }, "value": 10, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、分割、联用、停用或换药指令", "en": "labelled amount per tablet; not an individual's tablet count, splitting, co-use, stopping or switching instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-23", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 30, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "白色", "en": "white" }, "shape": { "zh": "圆形片；无刻痕", "en": "round tablet; no score" }, "imprint": "LILLY / 4117", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_80a421981d60495c", "label": "DailyMed（NLM）：ZYPREXA 奥氮平普通片、ZYDIS 口崩片及肌内注射剂当前美国公开标签（H2-Pharma LLC；SPL v68，2026-02-16 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b418946a-1ab4-4d89-a012-d94fc361a3c4", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-zyprexa-olanzapine-regular-tablet-15mg-30-bottle-ndc-6126963430", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（SPL v68，2026-02-16 发布；标签修订 2026-01）；仅为所引公开标签展示面，不代表供应", "en": "Current U.S. DailyMed public label (SPL v68, published 16 Feb 2026; label revised Jan 2026); cited public-label panel only, not availability" }, "dosageForm": { "zh": "ZYPREXA 奥氮平普通口服片（非 ZYDIS 口崩片或注射剂）", "en": "ZYPREXA olanzapine regular oral tablet (not ZYDIS orally disintegrating tablet or injection)" }, "route": { "zh": "口服（标签产品身份字段）", "en": "oral (label product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 61269-634-30", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片奥氮平 15 mg；30 片瓶装", "en": "Olanzapine 15 mg per tablet; 30-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=zyprexa-06.jpg&setid=b418946a-1ab4-4d89-a012-d94fc361a3c4&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "奥氮平", "en": "olanzapine" }, "value": 15, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、分割、联用、停用或换药指令", "en": "labelled amount per tablet; not an individual's tablet count, splitting, co-use, stopping or switching instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-23", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 30, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "蓝色", "en": "blue" }, "shape": { "zh": "椭圆形片；无刻痕", "en": "elliptical tablet; no score" }, "imprint": "LILLY / 4415", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_80a421981d60495c", "label": "DailyMed（NLM）：ZYPREXA 奥氮平普通片、ZYDIS 口崩片及肌内注射剂当前美国公开标签（H2-Pharma LLC；SPL v68，2026-02-16 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b418946a-1ab4-4d89-a012-d94fc361a3c4", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-zyprexa-olanzapine-regular-tablet-20mg-30-bottle-ndc-6126963530", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（SPL v68，2026-02-16 发布；标签修订 2026-01）；仅为所引公开标签展示面，不代表供应", "en": "Current U.S. DailyMed public label (SPL v68, published 16 Feb 2026; label revised Jan 2026); cited public-label panel only, not availability" }, "dosageForm": { "zh": "ZYPREXA 奥氮平普通口服片（非 ZYDIS 口崩片或注射剂）", "en": "ZYPREXA olanzapine regular oral tablet (not ZYDIS orally disintegrating tablet or injection)" }, "route": { "zh": "口服（标签产品身份字段）", "en": "oral (label product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 61269-635-30", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片奥氮平 20 mg；30 片瓶装", "en": "Olanzapine 20 mg per tablet; 30-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=zyprexa-07.jpg&setid=b418946a-1ab4-4d89-a012-d94fc361a3c4&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "奥氮平", "en": "olanzapine" }, "value": 20, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、分割、联用、停用或换药指令", "en": "labelled amount per tablet; not an individual's tablet count, splitting, co-use, stopping or switching instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-23", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 30, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "粉红色", "en": "pink" }, "shape": { "zh": "椭圆形片；无刻痕", "en": "elliptical tablet; no score" }, "imprint": "LILLY / 4420", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_80a421981d60495c", "label": "DailyMed（NLM）：ZYPREXA 奥氮平普通片、ZYDIS 口崩片及肌内注射剂当前美国公开标签（H2-Pharma LLC；SPL v68，2026-02-16 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b418946a-1ab4-4d89-a012-d94fc361a3c4", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-zyprexa-olanzapine-regular-tablet-10mg-30-bottle-ndc-6126963330", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=zyprexa-05.jpg&setid=b418946a-1ab4-4d89-a012-d94fc361a3c4&type=img", "alt": "ZYPREXA 奥氮平在美国 DailyMed 公开标签中的 10 mg、NDC 61269-633-30、30 片瓶装展示面", "archiveMarket": "美国", "labelVersion": "DailyMed SPL v68（2026-02-16 发布）", "presentation": "ZYPREXA 奥氮平普通口服片：每片 10 mg；NDC 61269-633-30；30 片瓶装展示面。", "notice": "此图只对应美国公开标签中的 ZYPREXA 普通口服片 10 mg、NDC 61269-633-30、30 片瓶装。它不代表 2.5/5/7.5/15/20 mg、ZYPREXA ZYDIS 口崩片、ZYPREXA IntraMuscular 注射剂、ZYPREXA RELPREVV、其他包装、其他市场或其他奥氮平产品；不用于鉴定真伪，也不生成个人片数、时间表、分片、联用、转换或停药方案。", "source": { "id": "src_80a421981d60495c", "label": "DailyMed（NLM）：ZYPREXA 奥氮平普通片、ZYDIS 口崩片及肌内注射剂当前美国公开标签（H2-Pharma LLC；SPL v68，2026-02-16 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b418946a-1ab4-4d89-a012-d94fc361a3c4", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "ZYPREXA 说明书放大阅读：普通片、口崩片、注射剂和 mg 必须分开核对", "en": "ZYPREXA label reading: keep regular tablets, orally disintegrating tablets, injections and mg markings separate" }, "summary": { "zh": "本模块以美国公开标签为阅读入口，帮助核对 ZYPREXA、奥氮平、普通口服片、每片标示强度、准确包装与目标市场；不提供个人片数、时间表、漏用补救、联用、换药、分片或停药建议。", "en": "This module uses the U.S. public label to check ZYPREXA, olanzapine, regular oral tablets, stated strength per tablet, the exact pack and target market; it provides no individual tablet count, schedule, missed-use remedy, co-use, switching, splitting or stopping advice." }, "checks": [ { "zh": "2.5、5、7.5、10、15、20 mg 是当前标签所列普通片的每片标示强度，不是“今天应服几片”的答案。本页图片仅对应 10 mg、NDC 61269-633-30、30 片瓶装；名称、颜色或 mg 相同都不能证明另一盒是同一产品。", "en": "2.5, 5, 7.5, 10, 15 and 20 mg are stated amounts per regular tablet in the current label, not an answer to ‘how many tablets today.’ The image on this page is only for 10 mg, NDC 61269-633-30, a 30-tablet bottle; a matching name, colour or mg marking does not establish that another pack is the same product." }, { "zh": "ZYPREXA ZYDIS 是口崩片，ZYPREXA IntraMuscular 是肌内注射剂，ZYPREXA RELPREVV 是另一种长效注射剂。不要因共同含奥氮平或同属 ZYPREXA 品牌家族，就自行改剂型、叠加、轮换、以注射剂替代片剂，或从包装数字推断怎样掰开；应由开方团队或药师核对实际处方与现行标签。", "en": "ZYPREXA ZYDIS is an orally disintegrating tablet, ZYPREXA IntraMuscular is an intramuscular injection, and ZYPREXA RELPREVV is a separate long-acting injection. Do not self-change form, combine, alternate, replace tablets with an injection or infer splitting from package numbers merely because they share olanzapine or the ZYPREXA brand family; have the actual prescription and current label reviewed by the prescribing team or pharmacist." }, { "zh": "美国标签提示痴呆相关精神病老年患者的重要限制：ZYPREXA 不获批用于这一人群。此处是标签阅读提示，不是网页对任何人的诊断或治疗结论；高龄、认知变化、跌倒、晕厥、嗜睡或多药并用时，应尽快让当地医疗团队核对全部药物和实际药盒。", "en": "The U.S. label carries an important limitation for elderly people with dementia-related psychosis: ZYPREXA is not approved for that population. This is a label-reading prompt, not a web diagnosis or treatment conclusion for any person; with older age, cognitive change, falls, fainting, drowsiness or multiple medicines, ask the local care team to review every medicine and actual pack promptly." }, { "zh": "标签列出可能影响血压的药物、左旋多巴/多巴胺激动剂，以及特定肌内注射场景下的劳拉西泮等需要专业复核的联用线索。它们不等于网页可以判断某个人能否同用、应如何错开、怎样加减或替换；带上完整药单与实际包装请药师或医生逐项核对。", "en": "The label identifies co-medication review cues including medicines that can affect blood pressure, levodopa/dopamine agonists, and lorazepam in a specific intramuscular context. They do not let a website decide whether a person can use them together, how to separate them, or how to change or replace anything; take the complete medicine list and actual packs to a pharmacist or clinician for item-by-item review." } ], "source": { "id": "src_80a421981d60495c", "label": "DailyMed（NLM）：ZYPREXA 奥氮平普通片、ZYDIS 口崩片及肌内注射剂当前美国公开标签（H2-Pharma LLC；SPL v68，2026-02-16 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b418946a-1ab4-4d89-a012-d94fc361a3c4", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "奥氮平怎样起作用：标签描述多种受体作用，但不能据此指导个人调整", "en": "How olanzapine works: the label describes several receptor actions, not a guide for personal adjustment" }, "summary": { "zh": "美国 ZYPREXA 标签称，所列适应症中的奥氮平作用机制尚不完全清楚，并描述其可能与多巴胺和 5HT2 型血清素受体拮抗的组合有关。它解释的是标签中的药理路径，不预测任何个人的症状、反应、适用性、片数、注射方案或联用结果。", "en": "The U.S. ZYPREXA label says olanzapine's mechanism in the listed indications is unclear and describes a possible combination of dopamine and serotonin type 2 (5HT2) antagonism. This explains a labelled pharmacologic pathway; it does not predict anyone's symptoms, response, suitability, tablet count, injection plan or co-use outcome." }, "checks": [ { "zh": "“作用于多巴胺和血清素受体”是理解药物类别的一条线索，不是网页判断幻觉、情绪、睡眠、行为或认知变化原因的工具，也不能替代由专业人员结合准确诊断、病程与完整药单作出的判断。", "en": "“Acts on dopamine and serotonin receptors” is one clue for understanding a medicine class; it is not a website tool for deciding the cause of hallucinations, mood, sleep, behavioural or cognitive changes, and cannot replace professional judgement using the exact diagnosis, course and complete medicine list." }, { "zh": "同为抗精神病药、都涉及相近受体或都可能使人困倦，不表示 ZYPREXA、SEROQUEL 或其他产品可以自行叠加、替换、轮换或按 mg 换算。品牌、准确剂型、释放方式、既往反应、身体状况和完整药单都必须由专业人员逐项核对。", "en": "Being antipsychotic medicines, involving related receptors or both potentially causing drowsiness does not permit self-combination, replacement, alternation or milligram conversion between ZYPREXA, SEROQUEL or another product. Brand, exact form, release characteristics, prior reactions, health context and the complete medicine list all need item-by-item professional review." }, { "zh": "机制文字不能处理突发的严重嗜睡、昏厥、跌倒、发热伴肌强直、胸部不适或明显行为改变。出现急性或严重担忧时，应优先使用当地医疗和紧急支持，而不是继续试验不同剂型或依据包装数字自行调整。", "en": "A mechanism explanation cannot manage sudden severe drowsiness, fainting, a fall, fever with muscle rigidity, chest discomfort or marked behavioural change. With an acute or serious concern, prioritise local medical and emergency support rather than experimenting with forms or adjusting from package numbers." } ], "source": { "id": "src_80a421981d60495c", "label": "DailyMed（NLM）：ZYPREXA 奥氮平普通片、ZYDIS 口崩片及肌内注射剂当前美国公开标签（Clinical Pharmacology；H2-Pharma LLC；SPL v68）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b418946a-1ab4-4d89-a012-d94fc361a3c4", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "Zyprexa", "generic": "奥氮平", "dosageFormClass": "普通口服片：2.5 mg、5 mg、7.5 mg、10 mg、15 mg、20 mg（美国公开标签所列；本档案分别建立六种 30 片瓶装身份；不与 ZYDIS 口崩片或注射剂合并）" }, "labelSource": { "id": "src_80a421981d60495c", "label": "DailyMed（NLM）：ZYPREXA 奥氮平普通片、ZYDIS 口崩片及肌内注射剂当前美国公开标签（H2-Pharma LLC；SPL v68，2026-02-16 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b418946a-1ab4-4d89-a012-d94fc361a3c4", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "productRoutes": [ { "source": { "id": "src_80a421981d60495c", "label": "DailyMed（NLM）：ZYPREXA 奥氮平普通片、ZYDIS 口崩片及肌内注射剂当前美国公开标签（H2-Pharma LLC；SPL v68，2026-02-16 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b418946a-1ab4-4d89-a012-d94fc361a3c4", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "DailyMed 的 ZYPREXA（olanzapine）美国公开标签同时收录普通口服片、ZYDIS 口崩片与肌内注射剂。本页分别建立普通口服片 2.5、5、7.5、10、15、20 mg 的六种准确 30 片瓶装，帮助核对品牌、通用名、剂型、每片标示强度、NDC、外观线索、标签版本与目标市场；不把任何 mg 数字转成个人片数、服用时间、漏用处理、联用、转换、分片或停药方案。", "history": "当前公开标签列示 Initial U.S. Approval: 1996。本页的六张卡片只对应所引美国标签中 2.5 mg（NDC 61269-630-30）、5 mg（61269-631-30）、7.5 mg（61269-632-30）、10 mg（61269-633-30）、15 mg（61269-634-30）、20 mg（61269-635-30）的各一瓶 30 片普通片。共享奥氮平成分或 ZYPREXA 品牌家族，并不能使普通片、ZYDIS 口崩片、肌内注射剂或 RELPREVV 长效注射剂可自行替换、合并、轮换或按经验掰分。", "sourceDocuments": [ { "id": "src_80a421981d60495c", "label": "DailyMed（NLM）：ZYPREXA 奥氮平普通片、ZYDIS 口崩片及肌内注射剂当前美国公开标签（H2-Pharma LLC；SPL v68，2026-02-16 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b418946a-1ab4-4d89-a012-d94fc361a3c4", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } ], "applicationNumber": "NDA 020592", "approvalTimeline": [ { "date": "1996", "title": { "zh": "当前标签所列美国初始批准年份", "en": "Initial U.S. approval year listed in the current label" }, "detail": { "zh": "当前 ZYPREXA 标签列示 Initial U.S. Approval: 1996。该年份仅定位这一美国档案，不建立其他市场的批准、供应或可售状态。", "en": "The current ZYPREXA label lists Initial U.S. Approval: 1996. This year locates this U.S. archive only; it does not establish approval, supply or sale status in another market." }, "source": { "id": "src_80a421981d60495c", "label": "DailyMed（NLM）：ZYPREXA 奥氮平普通片、ZYDIS 口崩片及肌内注射剂当前美国公开标签（H2-Pharma LLC；SPL v68，2026-02-16 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b418946a-1ab4-4d89-a012-d94fc361a3c4", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, { "date": "2026-02-16", "title": { "zh": "DailyMed 当前公开 SPL v68", "en": "Current public SPL v68 published on DailyMed" }, "detail": { "zh": "DailyMed 将该 ZYPREXA/ZYDIS/肌内注射剂合并标签的 SPL v68 发布日期列为 2026-02-16。本页仅选取其中普通片的准确 10 mg 包装面板，不将其外推为口崩片、注射剂、其他包装、库存或个人使用结论。", "en": "DailyMed lists 16 Feb 2026 as the publication date for SPL v68, a combined ZYPREXA/ZYDIS/intramuscular-injection label. This page selects only the exact regular-tablet 10 mg package panel and does not extend it to orally disintegrating tablets, injections, another pack, stock or individual use." }, "source": { "id": "src_80a421981d60495c", "label": "DailyMed（NLM）：ZYPREXA 奥氮平普通片、ZYDIS 口崩片及肌内注射剂当前美国公开标签（H2-Pharma LLC；SPL v68，2026-02-16 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b418946a-1ab4-4d89-a012-d94fc361a3c4", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "已链接普通片公开标签与准确 10 mg 包装面板", "en": "Regular-tablet public label and exact 10 mg package panel linked" }, "detail": { "zh": "本页展示的面板仅对应普通口服片 10 mg、NDC 61269-633-30、30 片瓶装；不建立实际在售、库存、个人片数、分片、联用或其他规格状态。", "en": "The displayed panel only corresponds to regular oral 10 mg tablets, NDC 61269-633-30, in a 30-tablet bottle; it does not establish actual availability, stock, individual tablet count, splitting, co-use or another-strength status." } }, { "market": { "zh": "美国 ZYDIS、肌内注射剂、RELPREVV 与中国大陆、欧盟、日本及其他市场", "en": "U.S. ZYDIS, intramuscular injection, RELPREVV and Mainland China, EU, Japan and other markets" }, "status": { "zh": "明确分开或待逐项建立市场记录", "en": "Explicitly separate or market record not established" }, "detail": { "zh": "ZYDIS 口崩片、肌内注射剂与 RELPREVV 长效注射剂都是不同产品呈现；不从本页普通片标签推定这些产品或其他市场的商品名、批准、规格、包装、供应、可售资格、原研/仿制关系或可替代性。", "en": "ZYDIS orally disintegrating tablets, intramuscular injection and RELPREVV long-acting injection are different product presentations. This regular-tablet label does not establish a trade name, approval, strength, pack, supply, sale eligibility, originator/generic relationship or interchangeability for those products or another market." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "ZYPREXA、ZYDIS 和注射剂都含奥氮平，能否只按 mg 自行换？", "en": "ZYPREXA, ZYDIS and injections all contain olanzapine. Can they be self-converted by mg?" }, "answer": { "zh": "不能。本页只建立美国普通口服片的公开标签阅读路径；ZYDIS、肌内注射剂和 RELPREVV 是不同产品呈现。共同成分、品牌家族或相近 mg 数字不能证明可自行互换、合并、轮换或按比例拆分。应由药师或开方团队核对实际处方、完整药单与目标市场的现行标签。", "en": "No. This page establishes the U.S. public-label reading path for regular oral tablets only; ZYDIS, intramuscular injection and RELPREVV are different product presentations. A shared ingredient, brand family or similar mg marking cannot establish self-substitution, co-use, alternation or proportional splitting. A pharmacist or prescribing team must review the actual prescription, complete medicine list and current target-market label." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/zyprexa/", "en": "https://origindrug.com/en/drugs/zyprexa/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "risperdal", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-28", "status": "published_traceable_archive" }, "names": { "brand": "RISPERDAL", "generic": "利培酮", "aliases": [ "RISPERDAL", "Risperdal", "risperidone", "利培酮" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "精神健康", "sourceArchiveMarket": "美国 RISPERDAL 利培酮现行公开标签（DailyMed 页面 2026-05-28 更新；标签同时覆盖普通口服片、口服液和 M-TAB 口崩片；本档案仅建立普通片阅读入口）", "dosageFormClass": "RISPERDAL 利培酮普通口服片：当前产品身份与供应信息列 0.5 mg、1 mg、2 mg、3 mg、4 mg；0.25 mg 仅见于标签给药文字，不是当前普通片包装规格（口服液和 M-TAB 口崩片不并入本档案）", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "1993（美国当前公开标签所列 Initial U.S. Approval）", "archiveSponsorText": "Janssen Pharmaceuticals, Inc.（DailyMed 当前美国公开标签所列）" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [ "RISPERDAL M-TAB", "risperidone orally disintegrating tablet", "RISPERDAL oral solution", "risperidone oral solution", "RISPERDAL CONSTA", "PERSERIS", "UZEDY", "利培酮口服液", "利培酮口崩片", "利培酮长效注射" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-risperdal-risperidone-regular-tablet-0-5mg-60-bottle-ndc-50458-302-06", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v43（2026-05-28 更新；2026-08-28 复核）", "en": "DailyMed SPL v43 (updated 28 May 2026; reviewed 28 Aug 2026)" }, "dosageForm": { "zh": "RISPERDAL 利培酮普通口服片（不包括口服液或 M-TAB 口崩片）", "en": "RISPERDAL risperidone regular oral tablet (not oral solution or M-TAB orally disintegrating tablet)" }, "route": { "zh": "口服（标签产品身份字段）", "en": "oral (label product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 50458-302-06", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片利培酮 0.5 mg；60 片瓶装（NDC 50458-302-06）", "en": "Risperidone 0.5 mg per tablet; 60-tablet bottle (NDC 50458-302-06)" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=risperdal-06.jpg&setid=7e117c7e-02fc-4343-92a1-230061dfc5e0&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "利培酮（每片普通口服片）", "en": "risperidone (per regular oral tablet)" }, "value": 0.5, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片普通口服片的标签标示量；不是个人片数、频率或换算指令", "en": "Labelled amount per regular oral tablet; not an individual's tablet count, frequency or conversion instruction" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-28", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "current_label_listed", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 60, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "红棕色", "en": "red-brown" }, "shape": { "zh": "胶囊形", "en": "capsule-shaped" }, "imprint": "JANSSEN / Ris 0.5", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_cc67c5a6cc1b3b0a", "label": "DailyMed（NLM）：RISPERDAL 利培酮当前美国公开标签（Janssen；SPL v43，2026-05-28 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=7e117c7e-02fc-4343-92a1-230061dfc5e0&version=43", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-26", "reviewedAt": "2026-08-26" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-risperdal-risperidone-regular-tablet-1mg-60-bottle-ndc-50458-300-06", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v43（2026-05-28 更新；2026-08-28 复核）", "en": "DailyMed SPL v43 (updated 28 May 2026; reviewed 28 Aug 2026)" }, "dosageForm": { "zh": "RISPERDAL 利培酮普通口服片（不包括口服液或 M-TAB 口崩片）", "en": "RISPERDAL risperidone regular oral tablet (not oral solution or M-TAB orally disintegrating tablet)" }, "route": { "zh": "口服（标签产品身份字段）", "en": "oral (label product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 50458-300-06", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片利培酮 1 mg；60 片瓶装（NDC 50458-300-06）", "en": "Risperidone 1 mg per tablet; 60-tablet bottle (NDC 50458-300-06)" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=risperdal-07.jpg&setid=7e117c7e-02fc-4343-92a1-230061dfc5e0&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "利培酮（每片普通口服片）", "en": "risperidone (per regular oral tablet)" }, "value": 1, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片普通口服片的标签标示量；不是个人片数、频率或换算指令", "en": "Labelled amount per regular oral tablet; not an individual's tablet count, frequency or conversion instruction" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-28", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "current_label_listed", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 60, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "白色", "en": "white" }, "shape": { "zh": "胶囊形", "en": "capsule-shaped" }, "imprint": "JANSSEN / R1", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_cc67c5a6cc1b3b0a", "label": "DailyMed（NLM）：RISPERDAL 利培酮当前美国公开标签（Janssen；SPL v43，2026-05-28 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=7e117c7e-02fc-4343-92a1-230061dfc5e0&version=43", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-26", "reviewedAt": "2026-08-26" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-risperdal-risperidone-regular-tablet-2mg-60-bottle-ndc-50458-320-06", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v43（2026-05-28 更新；2026-08-28 复核）", "en": "DailyMed SPL v43 (updated 28 May 2026; reviewed 28 Aug 2026)" }, "dosageForm": { "zh": "RISPERDAL 利培酮普通口服片（不包括口服液或 M-TAB 口崩片）", "en": "RISPERDAL risperidone regular oral tablet (not oral solution or M-TAB orally disintegrating tablet)" }, "route": { "zh": "口服（标签产品身份字段）", "en": "oral (label product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 50458-320-06", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片利培酮 2 mg；60 片瓶装（NDC 50458-320-06）", "en": "Risperidone 2 mg per tablet; 60-tablet bottle (NDC 50458-320-06)" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=risperdal-08.jpg&setid=7e117c7e-02fc-4343-92a1-230061dfc5e0&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "利培酮（每片普通口服片）", "en": "risperidone (per regular oral tablet)" }, "value": 2, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片普通口服片的标签标示量；不是个人片数、频率或换算指令", "en": "Labelled amount per regular oral tablet; not an individual's tablet count, frequency or conversion instruction" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-28", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "current_label_listed", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 60, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "橙色", "en": "orange" }, "shape": { "zh": "胶囊形", "en": "capsule-shaped" }, "imprint": "JANSSEN / R2", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_cc67c5a6cc1b3b0a", "label": "DailyMed（NLM）：RISPERDAL 利培酮当前美国公开标签（Janssen；SPL v43，2026-05-28 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=7e117c7e-02fc-4343-92a1-230061dfc5e0&version=43", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-26", "reviewedAt": "2026-08-26" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-risperdal-risperidone-regular-tablet-3mg-60-bottle-ndc-50458-330-06", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v43（2026-05-28 更新；2026-08-28 复核）", "en": "DailyMed SPL v43 (updated 28 May 2026; reviewed 28 Aug 2026)" }, "dosageForm": { "zh": "RISPERDAL 利培酮普通口服片（不包括口服液或 M-TAB 口崩片）", "en": "RISPERDAL risperidone regular oral tablet (not oral solution or M-TAB orally disintegrating tablet)" }, "route": { "zh": "口服（标签产品身份字段）", "en": "oral (label product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 50458-330-06", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片利培酮 3 mg；60 片瓶装（NDC 50458-330-06）", "en": "Risperidone 3 mg per tablet; 60-tablet bottle (NDC 50458-330-06)" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=risperdal-09.jpg&setid=7e117c7e-02fc-4343-92a1-230061dfc5e0&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "利培酮（每片普通口服片）", "en": "risperidone (per regular oral tablet)" }, "value": 3, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片普通口服片的标签标示量；不是个人片数、频率或换算指令", "en": "Labelled amount per regular oral tablet; not an individual's tablet count, frequency or conversion instruction" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-28", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "current_label_listed", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 60, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "黄色", "en": "yellow" }, "shape": { "zh": "胶囊形", "en": "capsule-shaped" }, "imprint": "JANSSEN / R3", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_cc67c5a6cc1b3b0a", "label": "DailyMed（NLM）：RISPERDAL 利培酮当前美国公开标签（Janssen；SPL v43，2026-05-28 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=7e117c7e-02fc-4343-92a1-230061dfc5e0&version=43", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-26", "reviewedAt": "2026-08-26" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-risperdal-risperidone-regular-tablet-4mg-60-bottle-ndc-50458-350-06", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v43（2026-05-28 更新；2026-08-28 复核）", "en": "DailyMed SPL v43 (updated 28 May 2026; reviewed 28 Aug 2026)" }, "dosageForm": { "zh": "RISPERDAL 利培酮普通口服片（不包括口服液或 M-TAB 口崩片）", "en": "RISPERDAL risperidone regular oral tablet (not oral solution or M-TAB orally disintegrating tablet)" }, "route": { "zh": "口服（标签产品身份字段）", "en": "oral (label product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 50458-350-06", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片利培酮 4 mg；60 片瓶装（NDC 50458-350-06）", "en": "Risperidone 4 mg per tablet; 60-tablet bottle (NDC 50458-350-06)" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=risperdal-10.jpg&setid=7e117c7e-02fc-4343-92a1-230061dfc5e0&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "利培酮（每片普通口服片）", "en": "risperidone (per regular oral tablet)" }, "value": 4, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片普通口服片的标签标示量；不是个人片数、频率或换算指令", "en": "Labelled amount per regular oral tablet; not an individual's tablet count, frequency or conversion instruction" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-28", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "current_label_listed", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 60, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "绿色", "en": "green" }, "shape": { "zh": "胶囊形", "en": "capsule-shaped" }, "imprint": "JANSSEN / R4", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_cc67c5a6cc1b3b0a", "label": "DailyMed（NLM）：RISPERDAL 利培酮当前美国公开标签（Janssen；SPL v43，2026-05-28 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=7e117c7e-02fc-4343-92a1-230061dfc5e0&version=43", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-26", "reviewedAt": "2026-08-26" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-risperdal-risperidone-regular-tablet-1mg-60-bottle-ndc-50458-300-06", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=risperdal-07.jpg&setid=7e117c7e-02fc-4343-92a1-230061dfc5e0&type=img", "alt": "RISPERDAL 利培酮在美国 DailyMed 当前标签中的 1 mg、NDC 50458-300-06、60 片瓶装展示面", "archiveMarket": "美国", "labelVersion": "DailyMed SPL v43（2026-05-28 更新；2026-08-28 复核）", "presentation": "RISPERDAL 利培酮普通口服片：每片 1 mg，NDC 50458-300-06，60 片瓶装展示面。", "notice": "此图只对应美国 DailyMed 当前标签中的 RISPERDAL、利培酮普通口服片 1 mg、NDC 50458-300-06 与 60 片瓶装。它只帮助核对商品名、通用名、每片标示量、普通片、包装数量、白色胶囊形片、JANSSEN／R1 刻印和来源；不用于鉴定真伪，也不证明 0.5/2/3/4 mg、给药文字出现的 0.25 mg、口服液、M-TAB 口崩片、长效注射剂、其他包装、其他市场、实时库存、原研身份、可替代性，或任何个人的片数、频率、停药、联用或换药方案。", "source": { "id": "src_cc67c5a6cc1b3b0a", "label": "DailyMed（NLM）：RISPERDAL 利培酮 1 mg、NDC 50458-300-06、60 片瓶装当前美国公开标签", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=7e117c7e-02fc-4343-92a1-230061dfc5e0&version=43", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-26", "reviewedAt": "2026-08-26" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "RISPERDAL 说明书放大阅读：先区分普通片、口服液和口崩片，再看老年人相关警示", "en": "RISPERDAL label reading: distinguish regular tablets, oral solution and orally disintegrating tablets before reading the older-adult warning" }, "summary": { "zh": "本模块使用美国 DailyMed 当前公开标签，帮助阅读 RISPERDAL、利培酮、普通口服片、口服液、M-TAB 口崩片和目标市场之间的区别。它不提供个人片数、给药时间、漏用补救、转换、合用、停用或诊断建议。", "en": "This module uses the current U.S. DailyMed public label to distinguish RISPERDAL, risperidone, regular tablets, oral solution, M-TAB orally disintegrating tablets and the target market. It provides no individual tablet count, timing, missed-use remedy, conversion, co-use, stopping or diagnostic advice." }, "checks": [ { "zh": "先把品牌、利培酮、实际剂型、每单位标示量、NDC、药盒和目标市场一起核对。当前普通片产品身份与供应信息只列 0.5 mg、1 mg、2 mg、3 mg、4 mg 五种 60 片瓶装；标签给药文字出现的 0.25 mg 不是第六种当前普通片包装。普通片、口服液和 M-TAB 口崩片也不是可由网页按毫克、片数或外观自行换算的同一呈现。", "en": "Check brand, risperidone, actual dosage form, labelled amount per unit, NDC, pack and target market together. Current product-identity and supply information lists only five regular-tablet 60-count bottles: 0.5 mg, 1 mg, 2 mg, 3 mg and 4 mg. A 0.25 mg figure in dosing text is not a sixth current regular-tablet package. Regular tablets, oral solution and M-TAB orally disintegrating tablets are also not presentations that a webpage can self-convert by milligrams, tablet count or appearance." }, { "zh": "美国标签有针对老年痴呆相关精神病患者的加框警示，并明确 RISPERDAL 不获批用于这一人群。它是阅读和尽快专业核对的提示，不是网页对任何人的诊断、处方、停药或照护结论。高龄、认知变化、跌倒、昏厥、异常嗜睡或多药并用时，应让当地医疗团队核对全部实际药盒。", "en": "The U.S. label has a boxed warning for elderly patients with dementia-related psychosis and states that RISPERDAL is not approved for that population. This is a reading and prompt-professional-review cue, not a webpage diagnosis, prescription, stopping or care decision for anyone. With older age, cognitive change, falls, fainting, unusual drowsiness or multiple medicines, have the local care team review every actual pack." }, { "zh": "不要因为产品都写利培酮、都用于精神健康，或都可能影响睡眠/行为，就自行叠加、隔天轮换、把口服制剂换成长效注射剂，或借用家人的药。请将处方药、非处方药、补充剂和实际药盒一起交给药师或开方团队逐项复核。", "en": "Do not self-combine, alternate on different days, change an oral product to a long-acting injection or borrow a family member's medicine because products all say risperidone, relate to mental health, or may affect sleep or behaviour. Take prescription medicines, OTC products, supplements and actual packs to a pharmacist or prescribing team for item-by-item review." }, { "zh": "出现呼吸困难、面部或舌部肿胀、昏厥、无法唤醒、发热伴肌强直、胸部不适、明显心律问题、严重跌倒或其他急性严重担忧时，应优先使用当地紧急医疗支持；不要等待网页检索或以另一种药物自行抵消。", "en": "With breathing difficulty, swelling of the face or tongue, fainting, inability to wake, fever with muscle rigidity, chest discomfort, a marked rhythm concern, a serious fall or another acute serious concern, prioritise local emergency medical support; do not wait for a website search or self-counteract with another medicine." } ], "source": { "id": "src_cc67c5a6cc1b3b0a", "label": "DailyMed（NLM）：RISPERDAL 利培酮当前美国公开标签（Janssen；SPL v43，2026-05-28 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=7e117c7e-02fc-4343-92a1-230061dfc5e0&version=43", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-26", "reviewedAt": "2026-08-26" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "利培酮怎样起作用：标签的受体作用描述不能替代个体化评估", "en": "How risperidone works: receptor descriptions in a label do not replace individual assessment" }, "summary": { "zh": "美国 RISPERDAL 标签将利培酮归为抗精神病药，并描述其对多巴胺 D2 和血清素 5HT2 受体的作用特性。该信息帮助理解标签中的类别词，不预测任何人的症状、反应、适用性、剂量、联用、转换或停药方案。", "en": "The U.S. RISPERDAL label classifies risperidone as an antipsychotic and describes activity at dopamine D2 and serotonin 5HT2 receptors. This helps read class terms in a label; it does not predict anyone's symptoms, response, suitability, dose, co-use, conversion or stopping plan." }, "checks": [ { "zh": "“作用于 D2/5HT2 受体”是药理线索，不是网页判断幻觉、情绪、睡眠、激越、认知变化或行为变化原因的工具，也不能替代专业人员结合诊断、检查、病程与完整药单作出的判断。", "en": "“Acts at D2/5HT2 receptors” is a pharmacology clue, not a website tool for deciding the cause of hallucinations, mood, sleep, agitation, cognitive change or behavioural change, and cannot replace professional judgement using diagnosis, tests, course and the complete medicine list." }, { "zh": "同为抗精神病药、都可能影响多巴胺或血清素，或都可能使人困倦，不表示 RISPERDAL、ZYPREXA、SEROQUEL 或其他产品可自行叠加、轮换、替代或按 mg 换算。品牌、准确剂型、释放方式、既往反应和完整药单都需要逐项核对。", "en": "Being antipsychotic medicines, affecting dopamine or serotonin, or potentially causing drowsiness does not make RISPERDAL, ZYPREXA, SEROQUEL or another product self-combinable, alternatable, substitutable or milligram-convertible. Brand, exact dosage form, release design, prior responses and the complete medicine list need item-by-item review." }, { "zh": "机制说明不能处理突发的严重嗜睡、昏厥、跌倒、发热伴肌强直、吞咽/呼吸问题、胸部不适或明显行为改变。遇到急性或严重担忧，应优先使用当地医疗和紧急支持，而不是自行改变任何药物。", "en": "A mechanism explanation cannot manage sudden severe drowsiness, fainting, a fall, fever with muscle rigidity, swallowing/breathing problems, chest discomfort or marked behavioural change. With an acute or serious concern, prioritise local medical and emergency support rather than self-changing any medicine." } ], "source": { "id": "src_cc67c5a6cc1b3b0a", "label": "DailyMed（NLM）：RISPERDAL 利培酮当前美国公开标签（Janssen；SPL v43，2026-05-28 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=7e117c7e-02fc-4343-92a1-230061dfc5e0&version=43", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-26", "reviewedAt": "2026-08-26" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "RISPERDAL", "generic": "利培酮", "dosageFormClass": "RISPERDAL 利培酮普通口服片：当前产品身份与供应信息列 0.5 mg、1 mg、2 mg、3 mg、4 mg；0.25 mg 仅见于标签给药文字，不是当前普通片包装规格（口服液和 M-TAB 口崩片不并入本档案）" }, "labelSource": { "id": "src_cc67c5a6cc1b3b0a", "label": "DailyMed（NLM）：RISPERDAL 利培酮当前美国公开标签（Janssen；SPL v43，2026-05-28 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=7e117c7e-02fc-4343-92a1-230061dfc5e0&version=43", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-26", "reviewedAt": "2026-08-26" }, "productRoutes": [ { "source": { "id": "src_cc67c5a6cc1b3b0a", "label": "DailyMed（NLM）：RISPERDAL 利培酮当前美国公开标签（Janssen；SPL v43，2026-05-28 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=7e117c7e-02fc-4343-92a1-230061dfc5e0&version=43", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-26", "reviewedAt": "2026-08-26" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-26", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-26", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "美国 DailyMed 当前 RISPERDAL 公开标签同时覆盖普通口服片、口服液与 M-TAB 口崩片；普通片产品身份与供应信息列 0.5 mg、1 mg、2 mg、3 mg、4 mg 五种 60 片瓶装。本页只帮助核对普通片、利培酮、准确包装、文件日期与目标市场，并把标签对老年痴呆相关精神病人群的限制放在前面阅读；标签给药文字出现的 0.25 mg 不是第六种当前普通片包装，也不能转化为任何人的片数、开始、停止、联用、换药或照护决定。", "history": "当前美国公开标签列示 Initial U.S. Approval: 1993。该年份只定位所引美国标签；本页不把 RISPERDAL 说成中国大陆、欧盟、日本或其他市场的现行品牌、供应或可替代产品。普通片、口服液、M-TAB 口崩片及各类长效注射剂是不同产品呈现，不能由共同成分或近似毫克数字自行替换、叠加或轮换。", "sourceDocuments": [ { "id": "src_cc67c5a6cc1b3b0a", "label": "DailyMed（NLM）：RISPERDAL 利培酮当前美国公开标签（Janssen；SPL v43，2026-05-28 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=7e117c7e-02fc-4343-92a1-230061dfc5e0&version=43", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-26", "reviewedAt": "2026-08-26" } ], "applicationNumber": "NDA 020272 / 021444（RISPERDAL 美国现行公开标签所列）", "approvalTimeline": [ { "date": "1993", "title": { "zh": "FDA 标签所列美国初始批准年份", "en": "Initial U.S. approval year listed in the FDA label" }, "detail": { "zh": "本页链接的 FDA 标签档案列示 Initial U.S. Approval: 1993。该历史定位不等同于当前批准、可得性、持有人或其他市场状态。", "en": "The FDA label archive linked here lists Initial U.S. Approval: 1993. This historical locator is not a conclusion about current approval, availability, holder or another market." }, "source": { "id": "src_cc67c5a6cc1b3b0a", "label": "DailyMed: RISPERDAL risperidone current U.S. public label", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=7e117c7e-02fc-4343-92a1-230061dfc5e0&version=43", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-26", "reviewedAt": "2026-08-26" } }, { "date": "DailyMed SPL v43, updated 2026-05-28", "title": { "zh": "FDA 标签档案版本", "en": "FDA label archive version" }, "detail": { "zh": "本页链接 DailyMed SPL v43, updated 2026-05-28 的 FDA 标签档案作为可复核阅读入口。现行标签、规格、适应症和安全信息必须另行以目标市场当前文件核对。", "en": "This page links the DailyMed SPL v43, updated 2026-05-28 FDA label archive as a traceable reading entry point. Current labeling, strength, indication and safety information require separate verification against the target market’s current document." }, "source": { "id": "src_cc67c5a6cc1b3b0a", "label": "DailyMed: RISPERDAL risperidone current U.S. public label", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=7e117c7e-02fc-4343-92a1-230061dfc5e0&version=43", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-26", "reviewedAt": "2026-08-26" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "已链接公开标签档案", "en": "Public label archive linked" }, "detail": { "zh": "仅对应本页所列 FDA 文件。", "en": "Only the FDA document listed on this page is linked." } }, { "market": { "zh": "中国大陆、欧盟、日本", "en": "Mainland China, EU, Japan" }, "status": { "zh": "待逐项建立市场记录", "en": "Market record not established" }, "detail": { "zh": "不从美国标签档案推定当地批准、持有人、规格、供应或可售资格。", "en": "No local approval, holder, strength, supply or sale-eligibility conclusion is inferred from the U.S. label archive." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "标签档案能代表现在的产品信息吗？", "en": "Does a label archive represent current product information?" }, "answer": { "zh": "不能自动代表。档案用于定位来源；需要以目标市场的现行官方标签逐项复核。", "en": "Not automatically. The archive locates a source; each point needs verification against the target market’s current official label." } }, { "question": { "zh": "为什么这里不展示价格或原研/仿制结论？", "en": "Why are price and originator/generic conclusions not shown?" }, "answer": { "zh": "这些结论需要产品、剂型、规格、包装、市场、日期和原始记录分别齐全并经人工审核；单一标签文件不足以支持。", "en": "Those conclusions require separately complete and human-reviewed product, dosage-form, strength, pack, market, date and primary-record fields; one label file is insufficient." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "how-to-read-a-drug-label", "regulatory-sources-first" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/risperdal/", "en": "https://origindrug.com/en/drugs/risperdal/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "wellbutrin-xl", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-28", "status": "published_traceable_archive" }, "names": { "brand": "WELLBUTRIN XL", "generic": "安非他酮", "aliases": [ "WELLBUTRIN XL", "bupropion", "bupropion hydrochloride", "安非他酮", "盐酸安非他酮" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "精神健康", "sourceArchiveMarket": "美国 WELLBUTRIN XL 盐酸安非他酮现行公开标签（DailyMed SPL v27，2026-02-06 发布；本档案仅建立缓释口服片阅读入口）", "dosageFormClass": "WELLBUTRIN XL 盐酸安非他酮缓释口服片：当前产品身份与供应信息列 150 mg、300 mg；450 mg 仅见于标签的用法和研究文字，不是当前产品包装规格", "dosageFormClassCode": "oral_modified_release", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "1985（美国当前公开标签所列 Initial U.S. Approval）", "archiveSponsorText": "Bausch Health US LLC（DailyMed 当前美国公开标签所列）" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [ "WELLBUTRIN SR", "WELLBUTRIN immediate release", "ZYBAN", "bupropion sustained-release tablet", "bupropion immediate-release tablet", "安非他酮缓释片", "安非他酮普通片" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-wellbutrin-xl-bupropion-hydrochloride-extended-release-tablet-150mg-30-bottle-ndc-0187-0730-30", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前公开标签（2026-02-06 发布；2026-08-28 复核）", "en": "Current DailyMed public label (published 6 Feb 2026; reviewed 28 Aug 2026)" }, "dosageForm": { "zh": "WELLBUTRIN XL 盐酸安非他酮缓释口服片", "en": "WELLBUTRIN XL bupropion hydrochloride extended-release oral tablet" }, "route": { "zh": "口服（标签产品身份字段）", "en": "oral (label product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 0187-0730-30", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片盐酸安非他酮 150 mg；30 片瓶装（NDC 0187-0730-30）", "en": "Bupropion hydrochloride 150 mg per tablet; 30-tablet bottle (NDC 0187-0730-30)" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=150carton.jpg&setid=a435da9d-f6e8-4ddc-897d-8cd2bf777b21&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "盐酸安非他酮（每片 XL 缓释片）", "en": "bupropion hydrochloride (per XL extended-release tablet)" }, "value": 150, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片 XL 缓释片的标签标示量；不是个人片数、频率或换算指令", "en": "Labelled amount per XL extended-release tablet; not an individual's tablet count, frequency or conversion instruction" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-28", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "current_label_listed", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 30, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "乳白至淡黄色", "en": "creamy white to pale yellow" }, "shape": { "zh": "圆形，约 7 mm", "en": "round, approximately 7 mm" }, "imprint": "WELLBUTRIN XL 150", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_549ddc8b0780f43f", "label": "DailyMed（NLM）：WELLBUTRIN XL 150 mg、NDC 0187-0730-30、30 片瓶装当前美国公开标签", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a435da9d-f6e8-4ddc-897d-8cd2bf777b21", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-wellbutrin-xl-bupropion-hydrochloride-extended-release-tablet-300mg-30-bottle-ndc-0187-0731-30", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前公开标签（2026-02-06 发布；2026-08-28 复核）", "en": "Current DailyMed public label (published 6 Feb 2026; reviewed 28 Aug 2026)" }, "dosageForm": { "zh": "WELLBUTRIN XL 盐酸安非他酮缓释口服片", "en": "WELLBUTRIN XL bupropion hydrochloride extended-release oral tablet" }, "route": { "zh": "口服（标签产品身份字段）", "en": "oral (label product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 0187-0731-30", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片盐酸安非他酮 300 mg；30 片瓶装（NDC 0187-0731-30）", "en": "Bupropion hydrochloride 300 mg per tablet; 30-tablet bottle (NDC 0187-0731-30)" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=300carton.jpg&setid=a435da9d-f6e8-4ddc-897d-8cd2bf777b21&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "盐酸安非他酮（每片 XL 缓释片）", "en": "bupropion hydrochloride (per XL extended-release tablet)" }, "value": 300, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片 XL 缓释片的标签标示量；不是个人片数、频率或换算指令", "en": "Labelled amount per XL extended-release tablet; not an individual's tablet count, frequency or conversion instruction" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-28", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "current_label_listed", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 30, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "乳白至淡黄色", "en": "creamy white to pale yellow" }, "shape": { "zh": "圆形，约 9 mm", "en": "round, approximately 9 mm" }, "imprint": "WELLBUTRIN XL 300", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_549ddc8b0780f43f", "label": "DailyMed（NLM）：WELLBUTRIN XL 300 mg、NDC 0187-0731-30、30 片瓶装当前美国公开标签", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a435da9d-f6e8-4ddc-897d-8cd2bf777b21", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-wellbutrin-xl-bupropion-hydrochloride-extended-release-tablet-150mg-30-bottle-ndc-0187-0730-30", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=150carton.jpg&setid=a435da9d-f6e8-4ddc-897d-8cd2bf777b21&type=img", "alt": "WELLBUTRIN XL 盐酸安非他酮在美国 DailyMed 当前标签中的 150 mg、NDC 0187-0730-30、30 片瓶装展示面", "archiveMarket": "美国", "labelVersion": "DailyMed 当前公开标签（2026-02-06 发布；2026-08-28 复核）", "presentation": "WELLBUTRIN XL 盐酸安非他酮：每片 150 mg，NDC 0187-0730-30，30 片瓶装展示面。", "notice": "此图只对应美国 DailyMed 当前标签中的 WELLBUTRIN XL、盐酸安非他酮 150 mg、NDC 0187-0730-30 与 30 片瓶装。它只帮助核对商品名、通用名、每片标示量、XL 缓释片、包装数量、片剂外观、刻印和来源；不用于鉴定真伪，也不证明 300 mg、标签其他章节出现的 450 mg、其他安非他酮剂型或品牌、其他包装、其他市场、实时库存、原研身份、可替代性，或任何个人的片数、频率、掰片、研碎、停药、联用或换药方案。", "source": { "id": "src_549ddc8b0780f43f", "label": "DailyMed（NLM）：WELLBUTRIN XL 150 mg、NDC 0187-0730-30、30 片瓶装当前美国公开标签", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a435da9d-f6e8-4ddc-897d-8cd2bf777b21", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "WELLBUTRIN XL 说明书放大阅读：先核对“XL 缓释片”，再看标签警示", "en": "WELLBUTRIN XL label reading: identify the XL extended-release tablet before reading label warnings" }, "summary": { "zh": "本模块使用美国 DailyMed 当前公开标签，帮助阅读 WELLBUTRIN XL、盐酸安非他酮、缓释口服片和目标市场之间的区别。它不提供个人片数、给药时间、漏用补救、转换、合用、停用或诊断建议。", "en": "This module uses the current U.S. DailyMed public label to distinguish WELLBUTRIN XL, bupropion hydrochloride, extended-release oral tablets and the target market. It provides no individual tablet count, timing, missed-use remedy, conversion, co-use, stopping or diagnostic advice." }, "checks": [ { "zh": "先把 WELLBUTRIN XL、盐酸安非他酮、XL 缓释口服片、实际每单位标示量、NDC、药盒和目标市场一起核对。当前产品身份与供应信息只列 150 mg、300 mg；标签其他章节出现的 450 mg 是用法或研究文字，不是第三种产品包装，更不是网页给任何人的片数、间隔或一日总量。", "en": "Check WELLBUTRIN XL, bupropion hydrochloride, the XL extended-release oral tablet, the actual labelled amount per unit, NDC, pack and target market together. Current product-identity and supply information lists only 150 mg and 300 mg. A 450 mg figure elsewhere in the label belongs to dosing or study text, not a third product package and not a webpage instruction for anyone's tablet count, interval or daily total." }, { "zh": "美国标签含有关于儿童、青少年和年轻成人抗抑郁药相关自杀想法和行为风险的加框警示，并提示密切观察变化。它是阅读、沟通和及时获取当地专业支持的提示，不是网页对任何人的诊断、处方、停药或照护结论。出现自伤/伤人想法、严重行为或情绪突变，或任何紧急担忧时，应优先使用当地紧急医疗与危机支持。", "en": "The U.S. label has a boxed warning about suicidal thoughts and behaviours associated with antidepressants in children, adolescents and young adults, and calls for close observation of changes. This is a cue for reading, communication and prompt local professional support, not a webpage diagnosis, prescription, stopping or care decision for anyone. With thoughts of self-harm or harm to others, a severe behavioural or mood change, or any urgent concern, prioritise local emergency medical and crisis support." }, { "zh": "标签提示癫痫发作风险。不要因为另一盒药也写安非他酮、也用于情绪/戒烟相关目的，或包装上有相近毫克数字，就自行叠加、隔天轮换、补用、掰开、研碎或替换。请将处方药、非处方药、补充剂和实际药盒一起交给药师或开方团队逐项复核。", "en": "The label warns about seizure risk. Do not self-combine, alternate on different days, make up a dose, split, crush or substitute because another pack also says bupropion, relates to mood or smoking cessation, or has a nearby milligram number. Take prescription medicines, OTC products, supplements and actual packs to a pharmacist or prescribing team for item-by-item review." }, { "zh": "出现呼吸困难、面部或舌部肿胀、昏厥、癫痫发作、无法唤醒、胸部不适、严重跌倒或其他急性严重担忧时，应优先使用当地紧急医疗支持；不要等待网页检索或以另一种药物自行抵消。", "en": "With breathing difficulty, swelling of the face or tongue, fainting, a seizure, inability to wake, chest discomfort, a serious fall or another acute serious concern, prioritise local emergency medical support; do not wait for a website search or self-counteract with another medicine." } ], "source": { "id": "src_549ddc8b0780f43f", "label": "DailyMed（NLM）：WELLBUTRIN XL 盐酸安非他酮缓释口服片当前美国公开标签（Bausch Health US LLC；SPL v27，2026-02-06 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a435da9d-f6e8-4ddc-897d-8cd2bf777b21", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "安非他酮怎样起作用：标签机制描述不能替代个体化评估", "en": "How bupropion works: label mechanism descriptions do not replace individual assessment" }, "summary": { "zh": "美国 WELLBUTRIN XL 标签将其归为氨基酮类抗抑郁药，并描述去甲肾上腺素和多巴胺再摄取抑制的药理特性。该信息帮助理解类别词，不预测任何人的症状、反应、适用性、剂量、联用、转换或停药方案。", "en": "The U.S. WELLBUTRIN XL label classifies it as an aminoketone antidepressant and describes pharmacological inhibition of norepinephrine and dopamine reuptake. This helps read class terms; it does not predict anyone's symptoms, response, suitability, dose, co-use, conversion or stopping plan." }, "checks": [ { "zh": "“影响去甲肾上腺素和多巴胺再摄取”是药理线索，不是网页判断情绪、睡眠、戒烟过程、认知变化、激越或行为变化原因的工具，也不能替代专业人员结合病史、检查、病程与完整药单作出的判断。", "en": "“Affects norepinephrine and dopamine reuptake” is a pharmacology clue, not a website tool for deciding the cause of mood, sleep, smoking-cessation, cognitive, agitation or behavioural changes, and cannot replace professional judgement using history, tests, course and the complete medicine list." }, { "zh": "同为抗抑郁药、都可能影响去甲肾上腺素/多巴胺，或都与情绪有关，不表示 WELLBUTRIN XL 与另一种抗抑郁药、安非他酮产品、镇静药或其他产品可自行叠加、轮换、替代或按 mg 换算。", "en": "Being antidepressants, affecting norepinephrine/dopamine, or relating to mood does not make WELLBUTRIN XL and another antidepressant, bupropion product, sedating medicine or other product self-combinable, alternatable, substitutable or milligram-convertible." }, { "zh": "机制说明不能处理癫痫发作、昏厥、严重焦虑或激越、明显情绪/行为改变、胸部不适、吞咽/呼吸问题或其他急性担忧。遇到急性或严重担忧，应优先使用当地医疗和紧急支持，而不是自行改变任何药物。", "en": "A mechanism explanation cannot manage a seizure, fainting, severe anxiety or agitation, a marked mood or behavioural change, chest discomfort, swallowing/breathing problems or another acute concern. With an acute or serious concern, prioritise local medical and emergency support rather than self-changing any medicine." } ], "source": { "id": "src_549ddc8b0780f43f", "label": "DailyMed（NLM）：WELLBUTRIN XL 盐酸安非他酮缓释口服片当前美国公开标签（Bausch Health US LLC；SPL v27，2026-02-06 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a435da9d-f6e8-4ddc-897d-8cd2bf777b21", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "WELLBUTRIN XL", "generic": "安非他酮", "dosageFormClass": "WELLBUTRIN XL 盐酸安非他酮缓释口服片：当前产品身份与供应信息列 150 mg、300 mg；450 mg 仅见于标签的用法和研究文字，不是当前产品包装规格" }, "labelSource": { "id": "src_549ddc8b0780f43f", "label": "DailyMed（NLM）：WELLBUTRIN XL 盐酸安非他酮缓释口服片当前美国公开标签（Bausch Health US LLC；SPL v27，2026-02-06 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a435da9d-f6e8-4ddc-897d-8cd2bf777b21", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" }, "productRoutes": [ { "source": { "id": "src_549ddc8b0780f43f", "label": "DailyMed（NLM）：WELLBUTRIN XL 盐酸安非他酮缓释口服片当前美国公开标签（Bausch Health US LLC；SPL v27，2026-02-06 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a435da9d-f6e8-4ddc-897d-8cd2bf777b21", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-28", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-28", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "美国 DailyMed 当前 WELLBUTRIN XL 公开标签将其列为盐酸安非他酮缓释口服片，产品身份与供应信息只列 150 mg 和 300 mg。本页帮助核对品牌、成分、缓释剂型、准确包装、文件日期和标签警示；标签其他章节出现的 450 mg 是用法或研究文字，不是第三种当前产品包装，也不能转化为任何人的片数、开始、停止、联用、换药或照护决定。", "history": "当前美国公开标签列示 Initial U.S. Approval: 1985，并标示 SPL v27 于 2026-02-06 发布。上述信息仅定位所引美国文件；不建立中国大陆、欧盟、日本或其他市场的现行品牌、供应、可购、可替代或个人治疗结论。WELLBUTRIN XL、其他安非他酮普通片、缓释片及其他品牌/用途的产品必须按准确剂型和现行标签分别核对。", "sourceDocuments": [ { "id": "src_549ddc8b0780f43f", "label": "DailyMed（NLM）：WELLBUTRIN XL 盐酸安非他酮缓释口服片当前美国公开标签（Bausch Health US LLC；SPL v27，2026-02-06 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a435da9d-f6e8-4ddc-897d-8cd2bf777b21", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" } ], "applicationNumber": "NDA 021515（WELLBUTRIN XL 美国现行公开标签所列）", "approvalTimeline": [ { "date": "1985", "title": { "zh": "FDA 标签所列美国初始批准年份", "en": "Initial U.S. approval year listed in the FDA label" }, "detail": { "zh": "本页链接的 FDA 标签档案列示 Initial U.S. Approval: 1985。该历史定位不等同于当前批准、可得性、持有人或其他市场状态。", "en": "The FDA label archive linked here lists Initial U.S. Approval: 1985. This historical locator is not a conclusion about current approval, availability, holder or another market." }, "source": { "id": "src_549ddc8b0780f43f", "label": "DailyMed: WELLBUTRIN XL bupropion hydrochloride current U.S. public label", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a435da9d-f6e8-4ddc-897d-8cd2bf777b21", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" } }, { "date": "DailyMed SPL v27, published 2026-02-06", "title": { "zh": "FDA 标签档案版本", "en": "FDA label archive version" }, "detail": { "zh": "本页链接 DailyMed SPL v27, published 2026-02-06 的 FDA 标签档案作为可复核阅读入口。现行标签、规格、适应症和安全信息必须另行以目标市场当前文件核对。", "en": "This page links the DailyMed SPL v27, published 2026-02-06 FDA label archive as a traceable reading entry point. Current labeling, strength, indication and safety information require separate verification against the target market’s current document." }, "source": { "id": "src_549ddc8b0780f43f", "label": "DailyMed: WELLBUTRIN XL bupropion hydrochloride current U.S. public label", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a435da9d-f6e8-4ddc-897d-8cd2bf777b21", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "已链接公开标签档案", "en": "Public label archive linked" }, "detail": { "zh": "仅对应本页所列 FDA 文件。", "en": "Only the FDA document listed on this page is linked." } }, { "market": { "zh": "中国大陆、欧盟、日本", "en": "Mainland China, EU, Japan" }, "status": { "zh": "待逐项建立市场记录", "en": "Market record not established" }, "detail": { "zh": "不从美国标签档案推定当地批准、持有人、规格、供应或可售资格。", "en": "No local approval, holder, strength, supply or sale-eligibility conclusion is inferred from the U.S. label archive." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "标签档案能代表现在的产品信息吗？", "en": "Does a label archive represent current product information?" }, "answer": { "zh": "不能自动代表。档案用于定位来源；需要以目标市场的现行官方标签逐项复核。", "en": "Not automatically. The archive locates a source; each point needs verification against the target market’s current official label." } }, { "question": { "zh": "为什么这里不展示价格或原研/仿制结论？", "en": "Why are price and originator/generic conclusions not shown?" }, "answer": { "zh": "这些结论需要产品、剂型、规格、包装、市场、日期和原始记录分别齐全并经人工审核；单一标签文件不足以支持。", "en": "Those conclusions require separately complete and human-reviewed product, dosage-form, strength, pack, market, date and primary-record fields; one label file is insufficient." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "how-to-read-a-drug-label", "regulatory-sources-first" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/wellbutrin-xl/", "en": "https://origindrug.com/en/drugs/wellbutrin-xl/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "remeron", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-25", "status": "published_traceable_archive" }, "names": { "brand": "REMERON", "generic": "米氮平", "aliases": [ "REMERON", "REMERONSolTab", "mirtazapine", "米氮平", "mirtazapine orally disintegrating tablet" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "精神健康", "sourceArchiveMarket": "美国：DailyMed 当前 REMERON / REMERONSolTab 公开标签（Organon；SPL v8，2025-08-06 生效）分别列示 REMERON 15/30 mg 普通片瓶装及 REMERONSolTab 15/30/45 mg 口腔崩解片泡罩包装。该文件不建立中国大陆、欧盟、日本或其他市场的商品名、批准、供应、可售资格、原研/仿制关系或可替代性。", "dosageFormClass": "米氮平普通薄膜衣口服片与口腔崩解片（美国当前公开标签所列）", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "1996（当前美国公开标签所列 Initial U.S. Approval）", "archiveSponsorText": "Organon LLC（所引美国公开标签所列标签方）" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [ "other mirtazapine package", "其他米氮平包装", "other antidepressant", "其他抗抑郁药" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-remeron-mirtazapine-tablet-15mg-ndc-78206-160-01", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（Organon；SPL v8，2025-08-06 生效）", "en": "Current U.S. DailyMed public label (Organon; SPL v8, effective 6 Aug 2025)" }, "dosageForm": { "zh": "REMERON 米氮平薄膜衣口服片", "en": "REMERON mirtazapine film-coated oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 78206-160-01", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片米氮平 15 mg；30 片瓶装", "en": "Mirtazapine 15 mg per tablet; 30-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=remeron-02.jpg&setid=98ad1917-a094-44f5-a28f-a64a8cfcd887&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "米氮平", "en": "mirtazapine" }, "value": 15, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、停用、联用、分片或换算指令", "en": "Labelled amount per tablet; not an individual's tablet count, stopping, co-use, splitting or conversion instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "片/盒", "en": "tablets per carton" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-25", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 30, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "黄色", "en": "yellow" }, "shape": { "zh": "椭圆形薄膜衣片；刻痕仅为准确产品外观线索，不是自行分片指示", "en": "oval film-coated tablet; scoring is an exact-product appearance clue, not a self-splitting instruction" }, "imprint": "MSD / T3Z", "scoreStatus": "scored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_fdcdf68b8a84531f", "label": "DailyMed（NLM）：REMERON / REMERONSolTab 米氮平当前美国公开标签（Organon；SPL v8，2025-08-06 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=98ad1917-a094-44f5-a28f-a64a8cfcd887&version=8", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-25", "reviewedAt": "2026-08-25" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-remeron-mirtazapine-tablet-30mg-ndc-78206-161-01", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（Organon；SPL v8，2025-08-06 生效）", "en": "Current U.S. DailyMed public label (Organon; SPL v8, effective 6 Aug 2025)" }, "dosageForm": { "zh": "REMERON 米氮平薄膜衣口服片", "en": "REMERON mirtazapine film-coated oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 78206-161-01", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片米氮平 30 mg；30 片瓶装", "en": "Mirtazapine 30 mg per tablet; 30-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=remeron-03.jpg&setid=98ad1917-a094-44f5-a28f-a64a8cfcd887&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "米氮平", "en": "mirtazapine" }, "value": 30, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、停用、联用、分片或换算指令", "en": "Labelled amount per tablet; not an individual's tablet count, stopping, co-use, splitting or conversion instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "片/盒", "en": "tablets per carton" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-25", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 30, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "红棕色", "en": "red-brown" }, "shape": { "zh": "椭圆形薄膜衣片；刻痕仅为准确产品外观线索，不是自行分片指示", "en": "oval film-coated tablet; scoring is an exact-product appearance clue, not a self-splitting instruction" }, "imprint": "MSD / T5Z", "scoreStatus": "scored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_fdcdf68b8a84531f", "label": "DailyMed（NLM）：REMERON / REMERONSolTab 米氮平当前美国公开标签（Organon；SPL v8，2025-08-06 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=98ad1917-a094-44f5-a28f-a64a8cfcd887&version=8", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-25", "reviewedAt": "2026-08-25" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-remeronsoltab-mirtazapine-odt-15mg-ndc-78206-156-01", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（Organon；SPL v8，2025-08-06 生效）", "en": "Current U.S. DailyMed public label (Organon; SPL v8, effective 6 Aug 2025)" }, "dosageForm": { "zh": "REMERONSolTab 米氮平口腔崩解片", "en": "REMERONSolTab mirtazapine orally disintegrating tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 78206-156-01", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片米氮平 15 mg；30 片泡罩包装纸盒", "en": "Mirtazapine 15 mg per tablet; 30-tablet blister-pack carton" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=remeron-04.jpg&setid=98ad1917-a094-44f5-a28f-a64a8cfcd887&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "米氮平", "en": "mirtazapine" }, "value": 15, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、停用、联用、分片或换算指令", "en": "Labelled amount per tablet; not an individual's tablet count, stopping, co-use, splitting or conversion instruction" } } ], "concentration": null, "container": { "typeCode": "blister_carton", "typeLabel": { "zh": "泡罩包装纸盒", "en": "blister-pack carton" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "片/盒", "en": "tablets per carton" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-25", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 30, "unit": { "zh": "片/盒", "en": "tablets per carton" } }, "physicalClues": { "color": { "zh": "白色至类白色", "en": "white to off-white" }, "shape": { "zh": "圆形口腔崩解片；标签明确不可掰开、咀嚼或压碎", "en": "round orally disintegrating tablet; the label says not to split, chew or crush" }, "imprint": "15", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_fdcdf68b8a84531f", "label": "DailyMed（NLM）：REMERON / REMERONSolTab 米氮平当前美国公开标签（Organon；SPL v8，2025-08-06 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=98ad1917-a094-44f5-a28f-a64a8cfcd887&version=8", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-25", "reviewedAt": "2026-08-25" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-remeronsoltab-mirtazapine-odt-30mg-ndc-78206-158-01", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（Organon；SPL v8，2025-08-06 生效）", "en": "Current U.S. DailyMed public label (Organon; SPL v8, effective 6 Aug 2025)" }, "dosageForm": { "zh": "REMERONSolTab 米氮平口腔崩解片", "en": "REMERONSolTab mirtazapine orally disintegrating tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 78206-158-01", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片米氮平 30 mg；30 片泡罩包装纸盒", "en": "Mirtazapine 30 mg per tablet; 30-tablet blister-pack carton" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=remeron-05.jpg&setid=98ad1917-a094-44f5-a28f-a64a8cfcd887&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "米氮平", "en": "mirtazapine" }, "value": 30, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、停用、联用、分片或换算指令", "en": "Labelled amount per tablet; not an individual's tablet count, stopping, co-use, splitting or conversion instruction" } } ], "concentration": null, "container": { "typeCode": "blister_carton", "typeLabel": { "zh": "泡罩包装纸盒", "en": "blister-pack carton" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "片/盒", "en": "tablets per carton" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-25", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 30, "unit": { "zh": "片/盒", "en": "tablets per carton" } }, "physicalClues": { "color": { "zh": "白色至类白色", "en": "white to off-white" }, "shape": { "zh": "圆形口腔崩解片；标签明确不可掰开、咀嚼或压碎", "en": "round orally disintegrating tablet; the label says not to split, chew or crush" }, "imprint": "30", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_fdcdf68b8a84531f", "label": "DailyMed（NLM）：REMERON / REMERONSolTab 米氮平当前美国公开标签（Organon；SPL v8，2025-08-06 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=98ad1917-a094-44f5-a28f-a64a8cfcd887&version=8", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-25", "reviewedAt": "2026-08-25" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-remeronsoltab-mirtazapine-odt-45mg-ndc-78206-159-01", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（Organon；SPL v8，2025-08-06 生效）", "en": "Current U.S. DailyMed public label (Organon; SPL v8, effective 6 Aug 2025)" }, "dosageForm": { "zh": "REMERONSolTab 米氮平口腔崩解片", "en": "REMERONSolTab mirtazapine orally disintegrating tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 78206-159-01", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片米氮平 45 mg；30 片泡罩包装纸盒", "en": "Mirtazapine 45 mg per tablet; 30-tablet blister-pack carton" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=remeron-06.jpg&setid=98ad1917-a094-44f5-a28f-a64a8cfcd887&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "米氮平", "en": "mirtazapine" }, "value": 45, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、停用、联用、分片或换算指令", "en": "Labelled amount per tablet; not an individual's tablet count, stopping, co-use, splitting or conversion instruction" } } ], "concentration": null, "container": { "typeCode": "blister_carton", "typeLabel": { "zh": "泡罩包装纸盒", "en": "blister-pack carton" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "片/盒", "en": "tablets per carton" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-25", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 30, "unit": { "zh": "片/盒", "en": "tablets per carton" } }, "physicalClues": { "color": { "zh": "白色至类白色", "en": "white to off-white" }, "shape": { "zh": "圆形口腔崩解片；标签明确不可掰开、咀嚼或压碎", "en": "round orally disintegrating tablet; the label says not to split, chew or crush" }, "imprint": "45", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_fdcdf68b8a84531f", "label": "DailyMed（NLM）：REMERON / REMERONSolTab 米氮平当前美国公开标签（Organon；SPL v8，2025-08-06 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=98ad1917-a094-44f5-a28f-a64a8cfcd887&version=8", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-25", "reviewedAt": "2026-08-25" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-remeron-mirtazapine-tablet-15mg-ndc-78206-160-01", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=remeron-02.jpg&setid=98ad1917-a094-44f5-a28f-a64a8cfcd887&type=img", "alt": "REMERON 米氮平 15 mg、NDC 78206-160-01、30 片瓶装在美国 DailyMed 当前公开标签中的包装图", "archiveMarket": "美国", "labelVersion": "DailyMed SPL v8（2025-08-06 生效）", "presentation": "REMERON 米氮平：每片 15 mg，NDC 78206-160-01，30 片瓶装（美国当前公开标签）。", "notice": "此图只对应美国 DailyMed 当前公开标签中的 REMERON、米氮平 15 mg、NDC 78206-160-01 与 30 片瓶装。它只帮助核对品牌、通用名、每片标示量、包装、外观和来源；不用于鉴定真伪，也不代表 REMERONSolTab、其他米氮平包装、其他精神健康相关产品、其他市场、当前可得性、原研身份、相等性、可替代性或任何个人的片数、停用、联用、换药或分片方案。", "source": { "id": "src_fdcdf68b8a84531f", "label": "DailyMed（NLM）：REMERON / REMERONSolTab 米氮平当前美国公开标签（Organon；SPL v8，2025-08-06 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=98ad1917-a094-44f5-a28f-a64a8cfcd887&version=8", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-25", "reviewedAt": "2026-08-25" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "REMERON／REMERONSolTab 说明书放大阅读：先分清普通片和口腔崩解片", "en": "REMERON / REMERONSolTab label reading: distinguish regular tablets from orally disintegrating tablets first" }, "summary": { "zh": "本模块只阅读美国 DailyMed 当前标签中的 REMERON、REMERONSolTab、米氮平、准确剂型、每片标示量、NDC、包装、外形与警示。它不提供个人片数、用药时间、停用、联用、换药、分片或购买方案。", "en": "This module reads only REMERON, REMERONSolTab, mirtazapine, the exact dosage form, labelled amount per tablet, NDC, package, appearance and warnings in the current U.S. DailyMed label. It provides no individual tablet count, timing, stopping, co-use, switching, splitting or purchase plan." }, "checks": [ { "zh": "先将 REMERON 或 REMERONSolTab、米氮平、普通片或口腔崩解片、每片 mg、实际 NDC、包装及目标市场一起核对。共同成分或相同 mg 数字不能建立自行互换、叠加、轮换或按比例换算。", "en": "Check REMERON or REMERONSolTab, mirtazapine, regular tablet or orally disintegrating tablet, milligrams per tablet, actual NDC, package and target market together. A shared ingredient or matching milligram number does not establish self-switching, combining, alternating or proportional conversion." }, { "zh": "当前标签所示 REMERON 普通片有刻痕；刻痕是这款准确普通片的外观线索，不是网页对任何人的分片、减量或转换许可。", "en": "The displayed REMERON regular tablets are scored. A score is an appearance clue for this exact regular tablet, not webpage permission for anyone to split, reduce or convert." }, { "zh": "当前标签对 REMERONSolTab 口腔崩解片明确写有不要掰开、咀嚼或压碎。该句话只适用于所引准确标签产品；也不应反过来把任何普通片、其他口崩片或其他药物当作可按同一方式处理。", "en": "The current label explicitly says not to split, chew or crush REMERONSolTab orally disintegrating tablets. This wording applies only to the exact cited label product; it also cannot be reversed into a rule for any regular tablet, another ODT or another medicine." }, { "zh": "标签对自杀意念或行为、血清素综合征、低钠、嗜睡和其他警示提供阅读入口。出现新的或加重的自伤/自杀想法、意识改变、呼吸困难、晕厥或其他急性令人担心的问题时，应优先使用当地紧急医疗支持；不要依据网页自行骤停、补用、加量或换成另一种产品。", "en": "The label provides reading entry points for suicidal thoughts or behaviours, serotonin syndrome, low sodium, somnolence and other warnings. With new or worsening thoughts of self-harm or suicide, mental-status change, breathing difficulty, fainting or another acute worrying problem, prioritise local urgent medical support; do not abruptly stop, make up, increase or change to another product from this webpage." } ], "source": { "id": "src_fdcdf68b8a84531f", "label": "DailyMed（NLM）：REMERON / REMERONSolTab 米氮平当前美国公开标签（Warnings, Precautions and Patient Counseling；Organon；SPL v8）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=98ad1917-a094-44f5-a28f-a64a8cfcd887&version=8", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-25", "reviewedAt": "2026-08-25" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "机制阅读：标签所述中枢 α2 受体相关药理，不是个人用药决策", "en": "Mechanism reading: central alpha-2-related pharmacology in the label is not a personal medication decision" }, "summary": { "zh": "当前标签说明米氮平用于重性抑郁障碍的作用机制尚不清楚，并描述其可能与中枢突触前 α2 肾上腺素能抑制性自身受体/异受体拮抗及去甲肾上腺素能、血清素能活性有关。这帮助理解标签术语；不回答个人诊断、是否应使用、如何与其他精神健康相关药物衔接、联用、调整或停用。", "en": "The current label says mirtazapine's mechanism for major depressive disorder is unclear and describes possible involvement of antagonism at central presynaptic alpha-2 adrenergic inhibitory autoreceptors and heteroreceptors with enhanced noradrenergic and serotonergic activity. This helps explain label terms; it does not answer an individual diagnosis, whether to use it, how to relate it to another mental-health medicine, co-use, adjustment or stopping." }, "checks": [ { "zh": "机制术语不能把 REMERON、REMERONSolTab 或另一种精神健康相关药物变成可自行选择、叠加、交替、换算或替代的产品。准确包装、现行标签和完整药单都需要专业人员一起核对。", "en": "Mechanism terms cannot turn REMERON, REMERONSolTab or another mental-health medicine into products that can be self-selected, combined, alternated, converted or substituted. The exact pack, current label and complete medicine list need professional review together." }, { "zh": "机制页不能解释个人的情绪、睡眠、食欲、眩晕或其他症状原因，也不能替代对既往反应、合并疾病、检查资料、酒精/非处方产品和完整药单的临床核对。", "en": "A mechanism page cannot explain the cause of an individual's mood, sleep, appetite, dizziness or another symptom, nor replace clinical review of prior reactions, coexisting conditions, test information, alcohol/OTC products and the complete medicine list." }, { "zh": "对任何急性安全担忧，尤其出现自伤/自杀想法、意识改变、呼吸困难、晕厥或严重不适时，应走当地紧急医疗渠道；不要靠包装、mg 或机制文字自行变更产品。", "en": "For any acute safety concern, especially thoughts of self-harm or suicide, mental-status change, breathing difficulty, fainting or severe illness, use local urgent medical pathways; do not change a product yourself from packaging, milligrams or mechanism wording." } ], "source": { "id": "src_fdcdf68b8a84531f", "label": "DailyMed（NLM）：REMERON / REMERONSolTab 米氮平当前美国公开标签（Clinical Pharmacology；Organon；SPL v8）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=98ad1917-a094-44f5-a28f-a64a8cfcd887&version=8", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-25", "reviewedAt": "2026-08-25" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "REMERON", "generic": "米氮平", "dosageFormClass": "米氮平普通薄膜衣口服片与口腔崩解片（美国当前公开标签所列）" }, "labelSource": { "id": "src_fdcdf68b8a84531f", "label": "DailyMed（NLM）：REMERON / REMERONSolTab 米氮平当前美国公开标签（Organon；SPL v8，2025-08-06 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=98ad1917-a094-44f5-a28f-a64a8cfcd887&version=8", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-25", "reviewedAt": "2026-08-25" }, "productRoutes": [ { "source": { "id": "src_fdcdf68b8a84531f", "label": "DailyMed（NLM）：REMERON / REMERONSolTab 米氮平当前美国公开标签（Organon；SPL v8，2025-08-06 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=98ad1917-a094-44f5-a28f-a64a8cfcd887&version=8", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-25", "reviewedAt": "2026-08-25" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-25", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-25", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "DailyMed 当前 REMERON / REMERONSolTab（mirtazapine）美国公开标签分别列示普通薄膜衣口服片与口腔崩解片。普通片 15/30 mg 的展示包装与 ODT 15/30/45 mg 的展示泡罩包装是不同的准确产品身份；本页帮助读者核对名称、通用名、剂型、每片标示量、NDC、包装、公开电子说明书及药物警戒阅读路径，不把任何字段转成个人片数、停用、联用、换药、分片或购买结论。", "history": "当前标签列示 Initial U.S. Approval: 1996，SPL v8 的 Effective Time 为 2025-08-06。普通片与 REMERONSolTab 即使通用名相同或 mg 数字相同，也须按准确剂型、包装和现行目标市场标签分别核对；不从共同成分推导自行互换、合并、轮换、压碎、咀嚼、掰开或停用。", "sourceDocuments": [ { "id": "src_fdcdf68b8a84531f", "label": "DailyMed（NLM）：REMERON / REMERONSolTab 米氮平当前美国公开标签（Organon；SPL v8，2025-08-06 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=98ad1917-a094-44f5-a28f-a64a8cfcd887&version=8", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-25", "reviewedAt": "2026-08-25" }, { "id": "src_5ed30b676fbb9773", "label": "FDA Drugs@FDA 官方检索入口（REMERON；NDA 020415 / 021208）", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_lookup_entry", "documentKind": "regulatory_lookup", "market": "US", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } ], "applicationNumber": "NDA 020415；NDA 021208", "approvalTimeline": [ { "date": "1996", "title": { "zh": "当前标签所列美国初始批准年份", "en": "Initial U.S. approval year listed in the current label" }, "detail": { "zh": "当前 REMERON / REMERONSolTab 美国公开标签列示 Initial U.S. Approval: 1996。该年份只定位所引美国标签历史，不建立中国大陆、欧盟、日本或其他市场的批准、供应、可售资格、原研/仿制关系或个人适用性。", "en": "The current U.S. REMERON / REMERONSolTab public label lists Initial U.S. Approval: 1996. This only locates the cited U.S. label history; it does not establish approval, supply, sale eligibility, originator/generic relationship or individual suitability in Mainland China, the EU, Japan or another market." }, "source": { "id": "src_fdcdf68b8a84531f", "label": "DailyMed（NLM）：REMERON / REMERONSolTab 米氮平当前美国公开标签（Organon；SPL v8）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=98ad1917-a094-44f5-a28f-a64a8cfcd887&version=8", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-25", "reviewedAt": "2026-08-25" } }, { "date": "2025-08-06", "title": { "zh": "当前 DailyMed SPL v8 生效日期", "en": "Current DailyMed SPL v8 effective date" }, "detail": { "zh": "DailyMed 当前 REMERON / REMERONSolTab 公开标签的 Effective Time 为 2025-08-06。本站分别展示两组普通片瓶装及三组口腔崩解片泡罩包装身份；不建立实际在售、库存、购买、个人片数、停用、联用、换药或其他市场状态。", "en": "The effective time of the current DailyMed REMERON / REMERONSolTab public label is 6 Aug 2025. This site separately displays two regular-tablet bottle identities and three ODT blister-pack identities; it does not establish actual availability, stock, purchase, individual tablet count, stopping, co-use, switching or another-market status." }, "source": { "id": "src_fdcdf68b8a84531f", "label": "DailyMed（NLM）：REMERON / REMERONSolTab 米氮平当前美国公开标签（Organon；SPL v8，2025-08-06 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=98ad1917-a094-44f5-a28f-a64a8cfcd887&version=8", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-25", "reviewedAt": "2026-08-25" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "已链接当前公开标签、两组普通片瓶装及三组口腔崩解片泡罩包装身份", "en": "Current public label, two regular-tablet bottle identities and three ODT blister-pack identities linked" }, "detail": { "zh": "本页分别记录 REMERON 15 mg、NDC 78206-160-01；30 mg、NDC 78206-161-01 的 30 片瓶装，以及 REMERONSolTab 15 mg、NDC 78206-156-01；30 mg、NDC 78206-158-01；45 mg、NDC 78206-159-01 的 30 片泡罩包装纸盒。它们只用于标签身份阅读，不用于鉴定真伪，也不建立实际在售、库存、购买、个人片数、停用、联用、换药或可替代性。", "en": "This page records REMERON 15 mg/NDC 78206-160-01 and 30 mg/NDC 78206-161-01 30-tablet bottles, plus REMERONSolTab 15 mg/NDC 78206-156-01, 30 mg/NDC 78206-158-01 and 45 mg/NDC 78206-159-01 30-tablet blister-pack cartons. They are for label-identity reading only; they do not authenticate a product or establish actual availability, stock, purchase, individual tablet count, stopping, co-use, switching or interchangeability." } }, { "market": { "zh": "中国大陆、欧盟、日本及其他市场", "en": "Mainland China, EU, Japan and other markets" }, "status": { "zh": "待逐项建立市场记录", "en": "Market record not established" }, "detail": { "zh": "不从美国标签、NDA、NDC、英文品牌、包装图或标签主体推定当地商品名、批准、包装、供应、可售资格、原研/仿制关系或可替代性；每个市场均须按当地现行监管资料单独核对。", "en": "No local trade name, approval, packaging, supply, sale eligibility, originator/generic relationship or interchangeability is inferred from the U.S. label, NDA, NDC, English brand, package image or label entity; every market requires separate checking against current local regulatory material." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "普通片与口腔崩解片都写米氮平、也可能有相同 mg，能否自己互换？", "en": "Both regular tablets and ODTs say mirtazapine and may show the same mg. Can they be self-switched?" }, "answer": { "zh": "不能。普通片与口腔崩解片是这份标签中分别列出的准确产品形态；共同成分、相同 mg、刻痕、颜色、包装图或品牌家族均不建立自行互换、叠加、交替、掰开、压碎、咀嚼、停用或转换关系。请把实际包装、NDC、现行处方和完整药单交给药师或开方团队核对。", "en": "No. Regular tablets and orally disintegrating tablets are distinct exact product forms in this label. A shared ingredient, matching mg, score, colour, package image or brand family does not establish self-switching, combining, alternating, splitting, crushing, chewing, stopping or conversion. Have a pharmacist or prescribing team review the actual package, NDC, current prescription and complete medicine list." } }, { "question": { "zh": "为什么页面写出自杀意念、血清素综合征等警示，却不告诉我是否该停药？", "en": "Why does the page mention suicidal thoughts and serotonin syndrome without telling me whether to stop?" }, "answer": { "zh": "这些是当前美国标签中警示、注意事项和患者咨询段落的阅读入口，不是个体化风险判断或治疗决策。出现新的或加重的自伤/自杀想法、意识改变、呼吸困难、晕厥或其他急性令人担心的问题时，应优先使用当地紧急医疗支持；任何产品变更须由了解实际处方、病史和完整药单的专业人员核对。", "en": "These are reading entry points for warnings, precautions and patient-counselling sections in the current U.S. label, not an individual risk assessment or treatment decision. With new or worsening thoughts of self-harm or suicide, mental-status change, breathing difficulty, fainting or another acute worrying problem, prioritise local urgent medical support; any product change requires review by a professional who knows the actual prescription, history and complete medicine list." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "dosage-forms-are-part-of-medicine-identity", "how-to-read-a-drug-label" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/remeron/", "en": "https://origindrug.com/en/drugs/remeron/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "ambien", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-25", "status": "published_traceable_archive" }, "names": { "brand": "AMBIEN", "generic": "酒石酸唑吡坦", "aliases": [ "AMBIEN", "zolpidem", "zolpidem tartrate", "唑吡坦", "酒石酸唑吡坦", "AMB 5", "AMB 10", "0024-5401-31", "0024-5421-31" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "精神健康", "sourceArchiveMarket": "美国：DailyMed 的有日期 AMBIEN 公开标签（SPL v26，2025-04-15 更新）列示酒石酸唑吡坦 5 mg、NDC 0024-5401-31 与 10 mg、NDC 0024-5421-31 的 100 片瓶装。该文件不建立中国大陆、欧盟、日本或其他市场的商品名、批准、供应、可售资格、原研/仿制关系、可替代性或个人适用性。", "dosageFormClass": "酒石酸唑吡坦薄膜衣口服片：每片 5 mg 或 10 mg（所引美国公开标签列示；均无刻痕）", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "1992（所引美国公开标签列示 Initial U.S. Approval）", "archiveSponsorText": "sanofi-aventis U.S. LLC（所引美国公开标签的品牌产品文件所列）" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [ "AMBIEN CR", "zolpidem tartrate extended-release", "zolpidem extended-release", "唑吡坦缓释片", "other zolpidem package", "其他唑吡坦包装" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-ambien-zolpidem-tartrate-tablet-5mg-100-bottle-ndc-0024-5401-31", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v26（2025-04-15 更新）", "en": "DailyMed SPL v26 (updated 15 Apr 2025)" }, "dosageForm": { "zh": "薄膜衣口服片", "en": "film-coated oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [], "productCode": "NDC 0024-5401-31", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "AMBIEN 酒石酸唑吡坦 5 mg、100 片瓶装", "en": "AMBIEN zolpidem tartrate 5 mg, 100-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=ambien-02.jpg&setid=c36cadf4-65a4-4466-b409-c82020b42452&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "酒石酸唑吡坦（每片）", "en": "Zolpidem tartrate (per tablet)" }, "value": 5, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标示量；不是个人片数、睡眠方案或调药规则", "en": "Labelled amount per tablet; not a personal tablet count, sleep plan or adjustment rule" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": null, "package": { "count": 100, "unit": { "zh": "片", "en": "tablets" } }, "physicalClues": { "color": { "zh": "粉色", "en": "pink" }, "shape": { "zh": "胶囊形", "en": "capsule-shaped" }, "imprint": { "zh": "AMB 5 / 5401", "en": "AMB 5 / 5401" }, "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_dc70521faf7d9d33", "label": "DailyMed（NLM）：AMBIEN 5 mg、NDC 0024-5401-31、100 片瓶装展示面（Sanofi；SPL v26）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=c36cadf4-65a4-4466-b409-c82020b42452&version=26", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-25", "reviewedAt": "2026-08-25" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-ambien-zolpidem-tartrate-tablet-10mg-100-bottle-ndc-0024-5421-31", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v26（2025-04-15 更新）", "en": "DailyMed SPL v26 (updated 15 Apr 2025)" }, "dosageForm": { "zh": "薄膜衣口服片", "en": "film-coated oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [], "productCode": "NDC 0024-5421-31", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "AMBIEN 酒石酸唑吡坦 10 mg、100 片瓶装", "en": "AMBIEN zolpidem tartrate 10 mg, 100-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=ambien-03.jpg&setid=c36cadf4-65a4-4466-b409-c82020b42452&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "酒石酸唑吡坦（每片）", "en": "Zolpidem tartrate (per tablet)" }, "value": 10, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标示量；不是个人片数、睡眠方案或调药规则", "en": "Labelled amount per tablet; not a personal tablet count, sleep plan or adjustment rule" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": null, "package": { "count": 100, "unit": { "zh": "片", "en": "tablets" } }, "physicalClues": { "color": { "zh": "白色", "en": "white" }, "shape": { "zh": "胶囊形", "en": "capsule-shaped" }, "imprint": { "zh": "AMB 10 / 5421", "en": "AMB 10 / 5421" }, "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_dc70521faf7d9d33", "label": "DailyMed（NLM）：AMBIEN 10 mg、NDC 0024-5421-31、100 片瓶装展示面（Sanofi；SPL v26）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=c36cadf4-65a4-4466-b409-c82020b42452&version=26", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-25", "reviewedAt": "2026-08-25" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-ambien-zolpidem-tartrate-tablet-5mg-100-bottle-ndc-0024-5401-31", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=ambien-02.jpg&setid=c36cadf4-65a4-4466-b409-c82020b42452&type=img", "alt": "AMBIEN 酒石酸唑吡坦 5 mg、NDC 0024-5401-31、100 片瓶装在美国 DailyMed 公开标签中的展示图", "archiveMarket": "美国", "labelVersion": "DailyMed SPL v26（2025-04-15 更新）", "presentation": "AMBIEN 酒石酸唑吡坦：每片 5 mg，NDC 0024-5401-31，100 片瓶装（美国有日期公开标签）。", "notice": "此图只对应所引美国 DailyMed 标签中的 AMBIEN、酒石酸唑吡坦 5 mg、NDC 0024-5401-31 与 100 片瓶装。它只帮助核对品牌、通用名、每片标示量、包装、外观和来源；不用于鉴定真伪，也不代表 10 mg、AMBIEN CR、缓释唑吡坦、其他唑吡坦包装、其他镇静安眠产品、其他市场、当前可得性、原研身份、相等性、可替代性或任何个人的服用、停用、联用、换药或分片方案。", "source": { "id": "src_dc70521faf7d9d33", "label": "DailyMed（NLM）：AMBIEN 酒石酸唑吡坦 5 mg、NDC 0024-5401-31、100 片瓶装有日期美国公开标签面板（Sanofi；SPL v26）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=c36cadf4-65a4-4466-b409-c82020b42452&version=26", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-25", "reviewedAt": "2026-08-25" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "AMBIEN／酒石酸唑吡坦说明书放大阅读：先分清准确片剂与 AMBIEN CR", "en": "AMBIEN label reading: distinguish the exact tablet from AMBIEN CR first" }, "summary": { "zh": "本模块只阅读所引美国 DailyMed 标签中的 AMBIEN、酒石酸唑吡坦、准确片剂、每片标示量、NDC、100 片瓶装、外形和警示。它不提供个人服用时间、片数、停用、联用、换药、分片或购买方案。", "en": "This module reads only AMBIEN, zolpidem tartrate, the exact tablet, labelled amount per tablet, NDC, 100-tablet bottle, appearance and warnings in the cited U.S. DailyMed label. It provides no individual timing, tablet count, stopping, co-use, switching, splitting or purchase plan." }, "checks": [ { "zh": "先同时核对 AMBIEN、酒石酸唑吡坦、5 mg 或 10 mg、实际 NDC、100 片瓶装、颜色、压印和目标市场。mg 是这个准确片剂的标示量，不是网页可转化为个人片数、睡眠方案、补用、加减或转换规则。", "en": "Check AMBIEN, zolpidem tartrate, 5 mg or 10 mg, the actual NDC, 100-tablet bottle, colour, imprint and target market together. mg is the labelled amount in an exact tablet, not a web rule for personal tablet count, sleep plan, make-up use, adjustment or conversion." }, { "zh": "所引标签中的 5 mg 和 10 mg 片均无刻痕。AMBIEN CR 或其他缓释唑吡坦不是这两组普通片身份的一部分；共同通用名、相近 mg、相似包装或“缓释”文字都不建立自行互换、掰开、压碎、叠加或替代关系。", "en": "Both 5 mg and 10 mg tablets in the cited label are unscored. AMBIEN CR or another extended-release zolpidem product is not part of either immediate-tablet identity; a shared generic name, nearby milligram number, similar package or extended-release wording does not establish self-switching, splitting, crushing, combining or substitution." }, { "zh": "标签含有“复杂睡眠行为”相关的方框警示，并提示可能造成严重伤害或死亡；也列有与酒精、其他中枢神经系统抑制性产品等共同出现时需要专业核对的内容。任何出现未完全清醒时的异常行为、受伤风险或即时安全担忧，应优先使用当地紧急医疗支持；不要依据网页自行用另一种安眠、镇静或止痛产品抵消、替代或组合。", "en": "The label has a boxed warning about complex sleep behaviours that may cause serious injury or death, and identifies alcohol and other central-nervous-system depressant products as matters for professional review. With an unusual behaviour while not fully awake, injury risk or an immediate safety concern, prioritise local urgent medical support; do not use this page to self-counteract, substitute or combine another sleep, sedating or pain product." }, { "zh": "标签特别提示老年人跌倒风险。头晕、意识混乱、跌倒、受伤、呼吸困难或其他急性令人担心的问题，需要把实际药盒、完整药单和情况交给当地医疗团队或药师；网页不能把年龄、睡眠描述、mg 或包装图变成继续、停用或换药决定。", "en": "The label specifically flags fall risk in older adults. With dizziness, confusion, a fall, injury, breathing difficulty or another acute worrying problem, take the actual pack, complete medicine list and circumstances to a local clinical team or pharmacist; a webpage cannot turn age, a sleep description, mg or a package image into a continue, stop or switching decision." } ], "source": { "id": "src_dc70521faf7d9d33", "label": "DailyMed（NLM）：AMBIEN 酒石酸唑吡坦有日期美国公开标签（Boxed Warning, Warnings and Precautions；Sanofi；SPL v26）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=c36cadf4-65a4-4466-b409-c82020b42452&version=26", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-25", "reviewedAt": "2026-08-25" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "酒石酸唑吡坦怎样起作用：标签中的 GABAA 受体阳性调节剂术语，不是个人睡眠用药方案", "en": "How zolpidem tartrate works: GABAA-receptor positive-modulator terminology in the label is not a personal sleep-medication plan" }, "summary": { "zh": "所引美国标签将酒石酸唑吡坦描述为咪唑并吡啶类 GABAA 受体阳性调节剂。这帮助读者理解标签术语；不解释个人失眠原因，也不判断是否应使用、与其他镇静安眠产品如何衔接、能否联用、何时改变或停止。", "en": "The cited U.S. label describes zolpidem tartrate as an imidazopyridine GABAA-receptor positive modulator. This helps readers understand label terminology; it does not explain an individual's insomnia, or decide whether to use it, how it relates to another sedating or sleep product, whether products can be combined, or when to change or stop." }, "checks": [ { "zh": "“作用于 GABAA 受体”或“安眠/镇静”都不是把 AMBIEN、AMBIEN CR、其他唑吡坦、苯二氮卓类、酒精、止痛药或非处方睡眠产品自行叠加、交替、替换或换算的依据。", "en": "“Acts at GABAA receptors” or “sleep/sedating” is not a basis for self-combining, alternating, substituting or converting AMBIEN, AMBIEN CR, another zolpidem product, a benzodiazepine, alcohol, a pain medicine or an OTC sleep product." }, { "zh": "机制页不能判断个人的睡眠问题、记忆改变、日间困倦、跌倒或意识变化是否由药物造成，也不能替代对年龄、既往反应、合并疾病、酒精/非处方产品和完整药单的专业核对。", "en": "A mechanism page cannot determine whether an individual's sleep issue, memory change, daytime drowsiness, fall or change in consciousness is medicine-related, nor replace professional review of age, prior reactions, coexisting conditions, alcohol/OTC products and the complete medicine list." }, { "zh": "出现未完全清醒时的异常行为、跌倒受伤、呼吸困难、意识改变或其他即时安全担忧时，应优先使用当地紧急医疗渠道；不要依据机制或包装文字自行改变多个产品。", "en": "With an unusual behaviour while not fully awake, a fall or injury, breathing difficulty, altered consciousness or another immediate safety concern, use local urgent medical pathways first; do not change several products yourself from mechanism or package text." } ], "source": { "id": "src_dc70521faf7d9d33", "label": "DailyMed（NLM）：AMBIEN 酒石酸唑吡坦有日期美国公开标签（Clinical Pharmacology；Sanofi；SPL v26）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=c36cadf4-65a4-4466-b409-c82020b42452&version=26", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-25", "reviewedAt": "2026-08-25" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "AMBIEN", "generic": "酒石酸唑吡坦", "dosageFormClass": "酒石酸唑吡坦薄膜衣口服片：每片 5 mg 或 10 mg（所引美国公开标签列示；均无刻痕）" }, "labelSource": { "id": "src_dc70521faf7d9d33", "label": "DailyMed (NLM): AMBIEN zolpidem tartrate dated U.S. public label (Sanofi; SPL v26, updated 15 Apr 2025)", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=c36cadf4-65a4-4466-b409-c82020b42452&version=26", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-25", "reviewedAt": "2026-08-25" }, "productRoutes": [ { "source": { "id": "src_dc70521faf7d9d33", "label": "DailyMed (NLM): AMBIEN zolpidem tartrate dated U.S. public label (Sanofi; SPL v26, updated 15 Apr 2025)", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=c36cadf4-65a4-4466-b409-c82020b42452&version=26", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-25", "reviewedAt": "2026-08-25" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-25", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-25", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "DailyMed 的有日期 AMBIEN（zolpidem tartrate）美国公开标签列示 5 mg、10 mg 两种薄膜衣口服片及对应 100 片瓶装。本页帮助读者把品牌、通用名、每片标示量、准确 NDC、无刻痕片、包装图、公开电子说明书和药物警戒阅读路径放在一起；不把毫克数、瓶数、睡眠问题或标签警示转换为个人服用时间、片数、联用、停用、换药、分片或购买结论。", "history": "所引 DailyMed 标签列示 Initial U.S. Approval: 1992，SPL v26 更新日期为 2025-04-15。5 mg、NDC 0024-5401-31 与粉色 AMB 5 / 5401 片，及 10 mg、NDC 0024-5421-31 与白色 AMB 10 / 5421 片，是两组分别记录的标签身份；AMBIEN CR、缓释唑吡坦、其他唑吡坦包装或其他镇静安眠产品须另按准确标签、剂型、包装与目标市场核对。", "sourceDocuments": [ { "id": "src_dc70521faf7d9d33", "label": "DailyMed (NLM): AMBIEN zolpidem tartrate dated U.S. public label (Sanofi; SPL v26, updated 15 Apr 2025)", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=c36cadf4-65a4-4466-b409-c82020b42452&version=26", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-25", "reviewedAt": "2026-08-25" }, { "id": "src_5ed30b676fbb9773", "label": "FDA Drugs@FDA official search", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_lookup_entry", "documentKind": "regulatory_lookup", "market": "US", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } ], "applicationNumber": "DailyMed SPL setid c36cadf4-65a4-4466-b409-c82020b42452（v26；有日期美国公开标签记录）", "approvalTimeline": [ { "date": "1992", "title": { "zh": "FDA 标签所列美国初始批准年份", "en": "Initial U.S. approval year listed in the FDA label" }, "detail": { "zh": "本页链接的 FDA 标签档案列示 Initial U.S. Approval: 1992。该历史定位不等同于当前批准、可得性、持有人或其他市场状态。", "en": "The FDA label archive linked here lists Initial U.S. Approval: 1992. This historical locator is not a conclusion about current approval, availability, holder or another market." }, "source": { "id": "src_dc70521faf7d9d33", "label": "DailyMed: AMBIEN zolpidem tartrate U.S. public label", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=c36cadf4-65a4-4466-b409-c82020b42452&version=26", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-25", "reviewedAt": "2026-08-25" } }, { "date": "2025-04-15 updated public label (SPL v26)", "title": { "zh": "FDA 标签档案版本", "en": "FDA label archive version" }, "detail": { "zh": "本页链接 2025-04-15 updated public label (SPL v26) 的 FDA 标签档案作为可复核阅读入口。现行标签、规格、适应症和安全信息必须另行以目标市场当前文件核对。", "en": "This page links the 2025-04-15 updated public label (SPL v26) FDA label archive as a traceable reading entry point. Current labeling, strength, indication and safety information require separate verification against the target market’s current document." }, "source": { "id": "src_dc70521faf7d9d33", "label": "DailyMed: AMBIEN zolpidem tartrate U.S. public label", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=c36cadf4-65a4-4466-b409-c82020b42452&version=26", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-25", "reviewedAt": "2026-08-25" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "已链接公开标签档案", "en": "Public label archive linked" }, "detail": { "zh": "仅对应本页所列 FDA 文件。", "en": "Only the FDA document listed on this page is linked." } }, { "market": { "zh": "中国大陆、欧盟、日本", "en": "Mainland China, EU, Japan" }, "status": { "zh": "待逐项建立市场记录", "en": "Market record not established" }, "detail": { "zh": "不从美国标签档案推定当地批准、持有人、规格、供应或可售资格。", "en": "No local approval, holder, strength, supply or sale-eligibility conclusion is inferred from the U.S. label archive." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "标签档案能代表现在的产品信息吗？", "en": "Does a label archive represent current product information?" }, "answer": { "zh": "不能自动代表。档案用于定位来源；需要以目标市场的现行官方标签逐项复核。", "en": "Not automatically. The archive locates a source; each point needs verification against the target market’s current official label." } }, { "question": { "zh": "为什么这里不展示价格或原研/仿制结论？", "en": "Why are price and originator/generic conclusions not shown?" }, "answer": { "zh": "这些结论需要产品、剂型、规格、包装、市场、日期和原始记录分别齐全并经人工审核；单一标签文件不足以支持。", "en": "Those conclusions require separately complete and human-reviewed product, dosage-form, strength, pack, market, date and primary-record fields; one label file is insufficient." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "how-to-read-a-drug-label", "regulatory-sources-first" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/ambien/", "en": "https://origindrug.com/en/drugs/ambien/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "glucophage", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-31", "status": "published_traceable_archive" }, "names": { "brand": "Glucophage", "generic": "二甲双胍", "aliases": [ "metformin", "盐酸二甲双胍", "盐酸二甲双胍片", "格华止" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": { "value": "格华止®", "status": "discovery_cue_requires_target_market_verification", "source": { "id": "src_6d71eb53f031aedf", "label": "张家港市人民政府：2025 年常用药品价格监测中的格华止／盐酸二甲双胍片记录", "url": "https://www.zjg.gov.cn/zjg/ylws_zxxx/202512/a8215ce44bae418497018522ae6d10ce.shtml", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "government_medicine_listing", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-12", "reviewedAt": "2026-09-12" } } }, "identity": { "therapeuticArea": "代谢", "sourceArchiveMarket": "美国 GLUCOPHAGE / GLUCOPHAGE XR 历史品牌档案；当前通用名 metformin 标签仅作剂型与安全阅读背景；欧盟成员国现行产品须逐国核对", "dosageFormClass": "盐酸二甲双胍口服普通片与缓释片；品牌、剂型、每片毫克数和市场必须同时核对", "dosageFormClassCode": "oral_modified_release", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "1995（GLUCOPHAGE）；2000（GLUCOPHAGE XR）", "archiveSponsorText": "Bristol-Myers Squibb 历史归档；FDA / DailyMed / EMA 官方资料" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-glucophage-immediate-release-500mg-100-tablet-bottle-ndc-0087-6060-05", "marketCode": "US", "labelVersion": { "zh": "DailyMed 公开历史归档（Bristol-Myers Squibb；代表性包装面板，非现行标签或供应结论）", "en": "DailyMed public historical archive (Bristol-Myers Squibb; representative package panel, not a current-label or availability conclusion)" }, "dosageForm": { "zh": "GLUCOPHAGE 盐酸二甲双胍口服薄膜衣片（历史归档包装）", "en": "GLUCOPHAGE metformin hydrochloride oral film-coated tablet (archived package)" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 0087-6060-05", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片 500 mg；100 片瓶装；普通片历史归档面板", "en": "500 mg per tablet; 100-tablet bottle; immediate-release historical package panel" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=glucophage-500mg-btl-lbl+.jpg&archiveid=453104", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "盐酸二甲双胍", "en": "metformin hydrochloride" }, "value": 500, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片历史标签标示量；不是个人片数、普通片/缓释片换算、掰开或调药规则", "en": "amount stated per tablet in the historical label; not an individual's tablet count, immediate-/extended-release conversion, splitting or adjustment rule" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "100 片瓶装（历史归档）", "en": "100-tablet bottle (historical archive)" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-21", "currentLabelDisplayed": false, "ndcDirectoryListed": false, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "白色至类白色", "en": "white to off-white" }, "shape": { "zh": "圆形薄膜衣片", "en": "round film-coated tablet" }, "imprint": "BMS 6060 / 500", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_ba675734307fb4d8", "label": "DailyMed（NLM）归档：GLUCOPHAGE / GLUCOPHAGE XR Bristol-Myers Squibb 历史美国公开标签", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=4a0166c7-7097-4e4a-9036-6c9a60d08fc6", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-glucophage-immediate-release-850mg-100-tablet-bottle-ndc-0087-6070-05", "marketCode": "US", "labelVersion": { "zh": "DailyMed 公开历史归档（Bristol-Myers Squibb；代表性包装面板，非现行标签或供应结论）", "en": "DailyMed public historical archive (Bristol-Myers Squibb; representative package panel, not a current-label or availability conclusion)" }, "dosageForm": { "zh": "GLUCOPHAGE 盐酸二甲双胍口服薄膜衣片（历史归档包装）", "en": "GLUCOPHAGE metformin hydrochloride oral film-coated tablet (archived package)" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 0087-6070-05", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片 850 mg；100 片瓶装；普通片历史归档面板", "en": "850 mg per tablet; 100-tablet bottle; immediate-release historical package panel" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=glucophage-850mg-btl-lbl.jpg&archiveid=453104", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "盐酸二甲双胍", "en": "metformin hydrochloride" }, "value": 850, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片历史标签标示量；不是个人片数、普通片/缓释片换算、掰开或调药规则", "en": "amount stated per tablet in the historical label; not an individual's tablet count, immediate-/extended-release conversion, splitting or adjustment rule" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "100 片瓶装（历史归档）", "en": "100-tablet bottle (historical archive)" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-21", "currentLabelDisplayed": false, "ndcDirectoryListed": false, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "白色至类白色", "en": "white to off-white" }, "shape": { "zh": "圆形薄膜衣片", "en": "round film-coated tablet" }, "imprint": "BMS 6070 / 850", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_ba675734307fb4d8", "label": "DailyMed（NLM）归档：GLUCOPHAGE / GLUCOPHAGE XR Bristol-Myers Squibb 历史美国公开标签", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=4a0166c7-7097-4e4a-9036-6c9a60d08fc6", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-glucophage-immediate-release-1000mg-100-tablet-bottle-ndc-0087-6071-11", "marketCode": "US", "labelVersion": { "zh": "DailyMed 公开历史归档（Bristol-Myers Squibb；代表性包装面板，非现行标签或供应结论）", "en": "DailyMed public historical archive (Bristol-Myers Squibb; representative package panel, not a current-label or availability conclusion)" }, "dosageForm": { "zh": "GLUCOPHAGE 盐酸二甲双胍口服薄膜衣片（历史归档包装）", "en": "GLUCOPHAGE metformin hydrochloride oral film-coated tablet (archived package)" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 0087-6071-11", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片 1000 mg；100 片瓶装；普通片历史归档面板", "en": "1000 mg per tablet; 100-tablet bottle; immediate-release historical package panel" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=glucophage-1000mg-btl-lbl.jpg&archiveid=453104", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "盐酸二甲双胍", "en": "metformin hydrochloride" }, "value": 1000, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片历史标签标示量；不是个人片数、普通片/缓释片换算、掰开或调药规则", "en": "amount stated per tablet in the historical label; not an individual's tablet count, immediate-/extended-release conversion, splitting or adjustment rule" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "100 片瓶装（历史归档）", "en": "100-tablet bottle (historical archive)" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-21", "currentLabelDisplayed": false, "ndcDirectoryListed": false, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "白色", "en": "white" }, "shape": { "zh": "椭圆形、双凸薄膜衣片", "en": "oval biconvex film-coated tablet" }, "imprint": "BMS 6071 / 1000", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_ba675734307fb4d8", "label": "DailyMed（NLM）归档：GLUCOPHAGE / GLUCOPHAGE XR Bristol-Myers Squibb 历史美国公开标签", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=4a0166c7-7097-4e4a-9036-6c9a60d08fc6", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-glucophage-xr-500mg-100-tablet-bottle-ndc-0087-6063-13", "marketCode": "US", "labelVersion": { "zh": "DailyMed 公开历史归档（Bristol-Myers Squibb；代表性包装面板，非现行标签或供应结论）", "en": "DailyMed public historical archive (Bristol-Myers Squibb; representative package panel, not a current-label or availability conclusion)" }, "dosageForm": { "zh": "GLUCOPHAGE XR 盐酸二甲双胍缓释片（历史归档包装）", "en": "GLUCOPHAGE XR metformin hydrochloride extended-release tablet (archived package)" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 0087-6063-13", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片 500 mg；100 片瓶装；缓释片历史归档面板", "en": "500 mg per tablet; 100-tablet bottle; extended-release historical package panel" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=glucophagexr-500mg-btl-lbl+.jpg&archiveid=453104", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "盐酸二甲双胍", "en": "metformin hydrochloride" }, "value": 500, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片历史标签标示量；不是个人片数、普通片/缓释片换算、掰开或调药规则", "en": "amount stated per tablet in the historical label; not an individual's tablet count, immediate-/extended-release conversion, splitting or adjustment rule" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "100 片瓶装（历史归档）", "en": "100-tablet bottle (historical archive)" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-21", "currentLabelDisplayed": false, "ndcDirectoryListed": false, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "白色至类白色", "en": "white to off-white" }, "shape": { "zh": "胶囊形、双凸缓释片", "en": "capsule-shaped biconvex extended-release tablet" }, "imprint": "BMS 6063 / 500", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_ba675734307fb4d8", "label": "DailyMed（NLM）归档：GLUCOPHAGE / GLUCOPHAGE XR Bristol-Myers Squibb 历史美国公开标签", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=4a0166c7-7097-4e4a-9036-6c9a60d08fc6", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-glucophage-xr-750mg-100-tablet-bottle-ndc-0087-6064-13", "marketCode": "US", "labelVersion": { "zh": "DailyMed 公开历史归档（Bristol-Myers Squibb；代表性包装面板，非现行标签或供应结论）", "en": "DailyMed public historical archive (Bristol-Myers Squibb; representative package panel, not a current-label or availability conclusion)" }, "dosageForm": { "zh": "GLUCOPHAGE XR 盐酸二甲双胍缓释片（历史归档包装）", "en": "GLUCOPHAGE XR metformin hydrochloride extended-release tablet (archived package)" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 0087-6064-13", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片 750 mg；100 片瓶装；缓释片历史归档面板", "en": "750 mg per tablet; 100-tablet bottle; extended-release historical package panel" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=glucophagexr-750mg-btl-lbl.jpg&archiveid=453104", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "盐酸二甲双胍", "en": "metformin hydrochloride" }, "value": 750, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片历史标签标示量；不是个人片数、普通片/缓释片换算、掰开或调药规则", "en": "amount stated per tablet in the historical label; not an individual's tablet count, immediate-/extended-release conversion, splitting or adjustment rule" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "100 片瓶装（历史归档）", "en": "100-tablet bottle (historical archive)" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-21", "currentLabelDisplayed": false, "ndcDirectoryListed": false, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "浅红色，可呈斑驳外观", "en": "pale red, possibly mottled" }, "shape": { "zh": "胶囊形、双凸缓释片", "en": "capsule-shaped biconvex extended-release tablet" }, "imprint": "BMS 6064 / 750", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_ba675734307fb4d8", "label": "DailyMed（NLM）归档：GLUCOPHAGE / GLUCOPHAGE XR Bristol-Myers Squibb 历史美国公开标签", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=4a0166c7-7097-4e4a-9036-6c9a60d08fc6", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-glucophage-immediate-release-500mg-100-tablet-bottle-ndc-0087-6060-05", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=glucophage-500mg-btl-lbl+.jpg&archiveid=453104", "alt": "GLUCOPHAGE 二甲双胍在美国 DailyMed Bristol-Myers Squibb 归档标签中的 500 mg、100 片装瓶装标签图", "archiveMarket": "美国", "labelVersion": "DailyMed 归档公开标签（Bristol-Myers Squibb，历史归档）", "presentation": "GLUCOPHAGE 片剂：每片盐酸二甲双胍 500 mg、100 片装瓶装标签图（DailyMed Bristol-Myers Squibb 归档标签所列）。", "notice": "此为美国 DailyMed 所存 Bristol-Myers Squibb GLUCOPHAGE 归档标签中明确对应二甲双胍 500 mg、100 片装的瓶装标签图，只帮助核对品牌、通用名、片剂、标示强度、包装数量和来源；不用于鉴定真伪，也不证明该历史标签所涉产品目前仍在任何市场可得，亦不证明 GLUCOPHAGE XR、其他规格、其他市场标签、原研身份、目标市场批准或可售资格。", "source": { "id": "src_ba675734307fb4d8", "label": "DailyMed（NLM）归档：GLUCOPHAGE / GLUCOPHAGE XR Bristol-Myers Squibb 历史美国公开标签", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=4a0166c7-7097-4e4a-9036-6c9a60d08fc6", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "GLUCOPHAGE XR 说明书放大阅读：缓释片不能当作普通片掰开", "en": "GLUCOPHAGE XR label reading: an extended-release tablet is not an ordinary tablet to split" }, "summary": { "zh": "本模块以 FDA 2018-05 美国历史标签为阅读入口，解释 GLUCOPHAGE 与 GLUCOPHAGE XR 的即时释放/缓释区别及“整片吞服”要求；它不制定个人降糖方案。", "en": "This module uses the May 2018 U.S. FDA historical label as a reading entry point, explaining the immediate-release/extended-release distinction and the “swallow whole” requirement for GLUCOPHAGE and GLUCOPHAGE XR; it does not create an individual glucose-lowering plan." }, "checks": [ { "zh": "该历史标签分别列出 GLUCOPHAGE 500、850、1000 mg 片剂，及 GLUCOPHAGE XR 500、750 mg 缓释片。相同通用名不代表这些不同剂型、规格和给药节奏能由自己按数字换算或替代。", "en": "This historical label separately lists GLUCOPHAGE 500, 850 and 1000 mg tablets and GLUCOPHAGE XR 500 and 750 mg extended-release tablets. A shared generic name does not make those different forms, strengths and dosing schedules self-convertible or interchangeable." }, { "zh": "FDA 标签对 GLUCOPHAGE XR 明确写明整片吞服，不能压碎、切开或咀嚼。因此“掰一半就等于减半”不能用于该缓释片；若吞咽困难、想减量或需改剂型，应先请开方团队或药师确认。", "en": "The FDA label explicitly says to swallow GLUCOPHAGE XR whole and never crush, cut or chew it. Therefore, “half a tablet equals half a dose” cannot be applied to this extended-release tablet; swallowing difficulty, a desired reduction or a form change should first be reviewed by the prescribing team or pharmacist." }, { "zh": "该标签把肾功能、碘造影检查、饮酒和部分联用药物列为需要专业评估的情境；高龄或多病共存时尤其不能只凭通用名、血糖读数或包装规格自行停用、换为缓释/普通片或临时加量。", "en": "The label identifies kidney function, iodinated contrast procedures, alcohol and some co-medications as situations requiring professional assessment. Especially with older age or multiple conditions, do not self-stop, change between extended-release and ordinary tablets, or temporarily increase use from a generic name, glucose reading or package strength alone." }, { "zh": "长期使用时，维生素 B12 与血液指标是说明书列出的复核线索；不要自行用补充剂替代检查，也不要因一次结果自行停药。应把近期检验、饮食/吸收问题及全部药物交给专业人员共同判断。", "en": "With long-term use, vitamin B12 and haematologic measures are label-listed review cues. Do not replace testing with self-selected supplements or stop from one result. Recent tests, diet or absorption concerns and the complete medicine list need professional review together." }, { "zh": "腹泻、恶心等不适不等于乳酸性酸中毒，网页也不能诊断原因；但若出现迅速加重的极度乏力、呼吸困难、明显嗜睡/意识改变、持续严重腹痛或循环不稳，应立即使用当地急救或紧急医疗服务，并带上准确药盒与完整药单。", "en": "Diarrhoea or nausea does not by itself mean lactic acidosis, and a webpage cannot diagnose the cause. Rapidly worsening extreme weakness, breathing difficulty, marked drowsiness or altered consciousness, persistent severe abdominal pain or circulatory instability requires local emergency care with the exact pack and complete medicine list." } ], "source": { "id": "src_8bffc6c29d4c394e", "label": "FDA：GLUCOPHAGE / GLUCOPHAGE XR 2018-05 处方信息（缓释片整片吞服要求）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020357s034%2C021202s018lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "二甲双胍怎样起作用：它同时涉及肝脏、肠道和身体对胰岛素的反应", "en": "How metformin works: it involves the liver, intestine and the body's response to insulin" }, "summary": { "zh": "FDA 的 GLUCOPHAGE / GLUCOPHAGE XR 公开标签描述：二甲双胍可减少肝脏葡萄糖生成、减少肠道葡萄糖吸收，并通过增加外周组织对葡萄糖的摄取和利用来改善胰岛素敏感性。这些是药理路径的概述，不是个人的剂量、联用、换药或停药方案。", "en": "The FDA public GLUCOPHAGE / GLUCOPHAGE XR label describes metformin as decreasing hepatic glucose production and intestinal glucose absorption, and improving insulin sensitivity by increasing peripheral glucose uptake and use. These are an overview of pharmacologic pathways, not an individual dose, combination, switch or stopping plan." }, "checks": [ { "zh": "不要把它简化为“只作用于一个器官”或“只要血糖高就能自己加用”。机制帮助理解标签语言，但不能替代诊断、近期检验、实际产品身份和个人处方的共同判断。", "en": "Do not simplify this into “it works on only one organ” or “a high glucose result means it can be self-added.” A mechanism helps read label language, but cannot replace the combined assessment of diagnosis, recent tests, actual product identity and an individual prescription." }, { "zh": "普通片与 GLUCOPHAGE XR 缓释片可有同一活性成分，但“同一机制”不使它们的剂型、强度、整片吞服要求或使用节奏可以自行换算。任何改为缓释/普通片、掰开或更改频率的想法都需先核对具体标签和药师/开方团队意见。", "en": "Ordinary tablets and GLUCOPHAGE XR extended-release tablets can share the active ingredient, but “the same mechanism” does not make their form, strength, swallow-whole requirement or schedule self-convertible. Any thought of changing between immediate- and extended-release forms, splitting, or changing frequency needs the exact label and pharmacist or prescribing-team review first." }, { "zh": "与其他降糖药、胰岛素、利尿剂或可能影响肾功能的产品同用时，机制只提示需要把完整药单和实际包装放在一起复核；它不能回答某个人应否叠加、替换、暂时停用或如何处理漏用。", "en": "When other glucose-lowering medicines, insulin, diuretics or products that may affect kidney function are also used, the mechanism only signals that the complete medicine list and actual packages need joint review; it cannot answer whether a person should add, substitute, temporarily stop or manage a missed use." } ], "source": { "id": "src_8bffc6c29d4c394e", "label": "FDA：GLUCOPHAGE / GLUCOPHAGE XR 2018-05 处方信息（临床药理）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020357s034%2C021202s018lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "Glucophage", "generic": "二甲双胍", "dosageFormClass": "盐酸二甲双胍口服普通片与缓释片；品牌、剂型、每片毫克数和市场必须同时核对" }, "labelSource": { "id": "src_8bffc6c29d4c394e", "label": "FDA：GLUCOPHAGE / GLUCOPHAGE XR 2018-05 处方信息（缓释片整片吞服要求）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020357s034%2C021202s018lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "productRoutes": [ { "source": { "id": "src_8bffc6c29d4c394e", "label": "FDA：GLUCOPHAGE / GLUCOPHAGE XR 2018-05 处方信息（缓释片整片吞服要求）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020357s034%2C021202s018lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_ba675734307fb4d8", "label": "DailyMed（NLM）归档：GLUCOPHAGE / GLUCOPHAGE XR Bristol-Myers Squibb 历史美国公开标签", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=4a0166c7-7097-4e4a-9036-6c9a60d08fc6", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_f7d2efc712cefcdb", "label": "FDA：GLUCOPHAGE / GLUCOPHAGE XR 2017 美国历史标签（NDA 020357 / 021202）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020357s037s039%2C021202s021s023lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [ { "id": "fda-2016-metformin-reduced-kidney-function-labelling-change", "issuedAt": "2016-04-08", "status": "fda_class_safety_communication", "title": { "zh": "FDA 药物安全通讯：含二甲双胍产品在肾功能减退人群中的标签更新", "en": "FDA Drug Safety Communication: labelling update for metformin-containing medicines in reduced kidney function" }, "summary": { "zh": "FDA 于 2016-04-08 发布对所有含二甲双胍药物的美国标签更新，说明其审查后将肾功能评价口径调整为 eGFR，并扩展了部分轻度及中度肾功能减退者的标签使用范围。该记录适用于二甲双胍成分层面的美国监管标签变更，不等于 GLUCOPHAGE、其缓释剂型、其他市场产品或任何个人都适合／不适合使用，也不提供自行开始、停止、减量、加量或将普通片换成缓释片的结论。肾功能、剂型和联用药物问题应以手中准确产品、目标市场现行说明书及开方团队或药师核对为准。", "en": "On 2016-04-08, FDA issued a U.S. labelling update for all metformin-containing medicines. After its review, FDA changed the kidney-function measure used in labelling to eGFR and expanded labelled use for some people with mild or moderate renal impairment. This is a U.S. ingredient-level regulatory labelling change. It does not determine whether GLUCOPHAGE, an extended-release form, a product in another market, or any individual is suitable or unsuitable, and it does not support self-starting, stopping, reducing, increasing, or exchanging immediate-release and extended-release products. Kidney function, dosage form and co-medication questions require the exact product, current target-market label and review by the prescribing team or pharmacist." }, "source": { "id": "src_c0757f8de2a30ee1", "label": "美国国家医学图书馆 Bookshelf：FDA 二甲双胍安全公告历史档案（含 2016-04-08 肾功能标签更新）", "url": "https://www.ncbi.nlm.nih.gov/books/NBK409379/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "FDA 的 GLUCOPHAGE / GLUCOPHAGE XR（metformin hydrochloride）2018-05 美国标签档案覆盖口服片剂与缓释片，并列出美国初始批准年份为 1995。DailyMed 所存 Bristol-Myers Squibb 归档标签保留五个可逐项核对的 100 片瓶装面板：GLUCOPHAGE 普通片 500/850/1000 mg，以及 GLUCOPHAGE XR 缓释片 500/750 mg。它们都是历史归档身份线索，不推定现行标签、当前包装、其他市场批准、持有人、原研关系、供应或可售资格。", "history": "本页五张瓶装标签图只分别对应美国 DailyMed 所存 Bristol-Myers Squibb 历史归档中的特定 NDC、强度、普通片或缓释片与 100 片瓶装；归档内各 NDC 均列有营销结束日期。它们不确认当前包装、产品真伪、其他市场或实际可得性。相同通用名及同一品牌家族下的普通片与缓释产品不能自动视为同一完整产品身份。", "sourceDocuments": [ { "id": "src_ba675734307fb4d8", "label": "DailyMed（NLM）归档：GLUCOPHAGE / GLUCOPHAGE XR Bristol-Myers Squibb 历史美国公开标签", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=4a0166c7-7097-4e4a-9036-6c9a60d08fc6", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_f7d2efc712cefcdb", "label": "FDA：GLUCOPHAGE / GLUCOPHAGE XR 2017 美国历史标签（NDA 020357 / 021202）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020357s037s039%2C021202s021s023lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_ae71b241c29fe815", "label": "FDA：2025 临床审评中的 metformin / metformin XR 美国监管历史", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2025/216778Orig1s000MedR.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "regulatory_review", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_d3223f16818206ea", "label": "DailyMed（NLM）：当前通用名 metformin hydrochloride 普通片标签（仅作当前剂型与安全阅读背景）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=0f251f2c-97f3-4048-84f2-81fea03685aa", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "generic_product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_8978b60669978d12", "label": "DailyMed（NLM）：当前通用名 metformin hydrochloride 缓释片标签（仅作当前剂型与安全阅读背景）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=1d0b74de-ef4c-4dd2-8019-2ddb409c60b4", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "generic_product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_ee8d8ba271a3603e", "label": "EMA：metformin 与含 metformin 药品转介及成员国授权背景", "url": "https://www.ema.europa.eu/en/medicines/human/referrals/metformin-metformin-containing-medicines", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_reference", "market": "EU", "accessStatus": "public_access_with_site_controls", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_5ed30b676fbb9773", "label": "FDA Drugs@FDA 官方检索入口", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_lookup_entry", "documentKind": "regulatory_lookup", "market": "US", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } ], "applicationNumber": "FDA NDA 020357（GLUCOPHAGE）／NDA 021202（GLUCOPHAGE XR）", "approvalTimeline": [ { "date": "1995-03-03", "title": { "zh": "FDA 批准 GLUCOPHAGE", "en": "FDA approved GLUCOPHAGE" }, "detail": { "zh": "FDA 2025 临床审评的监管历史表将 NDA 020357 与该日期及 Glucophage 相连；这是美国历史批准节点，不是当前供应证明。", "en": "The regulatory-history table in a 2025 FDA clinical review links NDA 020357, this date and Glucophage; it is a U.S. historical approval node, not evidence of current supply." }, "source": { "id": "src_ae71b241c29fe815", "label": "FDA：2025 临床审评中的 metformin 美国监管历史表", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2025/216778Orig1s000MedR.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "regulatory_review", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, { "date": "2000-10-13", "title": { "zh": "FDA 批准 GLUCOPHAGE XR", "en": "FDA approved GLUCOPHAGE XR" }, "detail": { "zh": "同一 FDA 监管历史表将 NDA 021202 与 Glucophage XR 相连；普通片和缓释片必须按完整产品身份分别阅读。", "en": "The same FDA regulatory-history table links NDA 021202 to Glucophage XR; immediate-release and extended-release products must be read as distinct complete identities." }, "source": { "id": "src_ae71b241c29fe815", "label": "FDA：2025 临床审评中的 metformin XR 美国监管历史表", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2025/216778Orig1s000MedR.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "regulatory_review", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, { "date": "2017-04", "title": { "zh": "美国历史品牌标签更新节点", "en": "U.S. historical brand-label update node" }, "detail": { "zh": "该标签列出 GLUCOPHAGE 500/850/1000 mg 与 GLUCOPHAGE XR 500/750 mg，并明确文件可能不是 FDA 最新标签。", "en": "This label lists GLUCOPHAGE 500/850/1000 mg and GLUCOPHAGE XR 500/750 mg and explicitly warns that it may not be the latest FDA-approved label." }, "source": { "id": "src_f7d2efc712cefcdb", "label": "FDA：GLUCOPHAGE / GLUCOPHAGE XR 2017 美国历史标签（Reference ID 4079189）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020357s037s039%2C021202s021s023lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } } ], "marketStatus": [ { "market": { "zh": "美国历史品牌档案", "en": "U.S. historical brand archive" }, "status": { "zh": "五个历史品牌包装已逐项建档；不宣称当前品牌供应", "en": "Five historical brand packages are itemised; current brand supply is not claimed" }, "detail": { "zh": "页面保留 NDC、每片毫克数、普通片/缓释片、片面刻字与历史标签来源。当前通用名标签只能补充安全阅读背景，不能冒充当前 GLUCOPHAGE 品牌标签。", "en": "The page preserves NDC, per-tablet milligrams, immediate/extended-release form, tablet imprint and historical-label source. Current generic labels may add safety-reading context but must not be presented as current GLUCOPHAGE brand labels." } }, { "market": { "zh": "欧盟及成员国", "en": "EU and member states" }, "status": { "zh": "metformin 产品为成员国层面授权；品牌与现行说明书须逐国核对", "en": "Metformin products are nationally authorised; brand and current leaflet require country-by-country checking" }, "detail": { "zh": "EMA 的转介页面说明相关产品包含 Glucophage 等名称，但不由此推定任一国家的当前包装、供应、原研关系或可替代性。", "en": "The EMA referral page notes products including the name Glucophage, but this does not establish current pack, supply, originator status or interchangeability in any country." } }, { "market": { "zh": "中国大陆、日本及其他市场", "en": "Mainland China, Japan and other markets" }, "status": { "zh": "现行市场记录待逐项建立", "en": "Current market record not yet established" }, "detail": { "zh": "不从美国历史品牌或通用名推定当地商品名、批准、包装、供应或换药关系。", "en": "No local trade name, approval, pack, supply or switching relationship is inferred from the U.S. historical brand or generic name." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "500 mg 是一盒有 500 片吗？", "en": "Does 500 mg mean there are 500 tablets in the pack?" }, "answer": { "zh": "不是。这里的 500 mg 是每片标签标示的盐酸二甲双胍量；包装片数是另一个字段。个人一次吃几片、一天几次必须看准确处方，不能从 mg 自行推算。", "en": "No. Here, 500 mg is the labelled metformin hydrochloride amount per tablet; pack count is a separate field. Tablets per use and uses per day require the exact prescription and cannot be inferred from mg alone." } }, { "question": { "zh": "GLUCOPHAGE XR 能掰一半吗？", "en": "Can GLUCOPHAGE XR be split in half?" }, "answer": { "zh": "历史品牌标签要求 GLUCOPHAGE XR 整片吞服，不得压碎或咀嚼；当前通用名缓释标签进一步明确不得切开。不要自行掰片；吞咽困难或需调整时请带准确包装咨询药师或开方团队。", "en": "The historical brand label requires GLUCOPHAGE XR to be swallowed whole and not crushed or chewed; current generic extended-release labels further say not to cut it. Do not split it yourself; take the exact pack to a pharmacist or prescriber if swallowing is difficult or a change is needed." } }, { "question": { "zh": "做增强 CT 或血管造影前需要停药吗？", "en": "Must it be stopped before contrast CT or angiography?" }, "answer": { "zh": "不能只凭“要做造影”自行停药。标签把造影剂类型、给药途径、肾功能、肝病、心衰与饮酒史等列为共同判断因素；应提前把检查通知和近期肾功能结果交给开方团队/检查机构，按其具体指示处理。", "en": "Do not stop it yourself merely because contrast imaging is planned. The label considers contrast type and route, kidney function, liver disease, heart failure and alcohol history together. Give the imaging notice and recent kidney results to the prescriber and imaging service in advance and follow their specific instructions." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "dosage-forms-are-part-of-medicine-identity", "how-to-read-a-drug-label" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/glucophage/", "en": "https://origindrug.com/en/drugs/glucophage/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "amaryl", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-23", "status": "published_traceable_archive" }, "names": { "brand": "Amaryl", "generic": "格列美脲", "aliases": [ "AMARYL", "glimepiride", "格列美脲" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "代谢", "sourceArchiveMarket": "美国：DailyMed 历史公开标签（2018-12 修订）。该标签记录三种瓶装的美国营销终止日期为 2023-08-31；本页因此仅作历史文件和药盒身份阅读，不将其表述为当前在售、供应或任何其他市场状态。", "dosageFormClass": "格列美脲口服片：1 mg、2 mg、4 mg（历史美国标签所列；各 100 片瓶装）", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "1995（历史美国标签所列初始批准年份）", "archiveSponsorText": "Sanofi-Aventis U.S. LLC（历史美国标签所列标签方）" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [ "glimepiride generic tablet", "格列美脲仿制片", "glimepiride injection", "格列美脲注射液" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-amaryl-glimepiride-tablet-1mg-100-bottle-ndc-0039022110-historical", "marketCode": "US", "labelVersion": { "zh": "DailyMed 美国历史公开标签（Sanofi-Aventis；2018-12 修订；标签记录美国营销终止于 2023-08-31）", "en": "U.S. DailyMed historical public label (Sanofi-Aventis; revised Dec 2018; label records U.S. marketing ended 31 Aug 2023)" }, "dosageForm": { "zh": "AMARYL 格列美脲口服片（历史美国标签）", "en": "AMARYL glimepiride oral tablet (historical U.S. label)" }, "route": { "zh": "口服（历史标签产品身份字段）", "en": "oral (historical-label product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 0039-0221-10", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片格列美脲 1 mg；100 片瓶装（美国历史标签）", "en": "Glimepiride 1 mg per tablet; 100-tablet bottle (historical U.S. label)" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "格列美脲", "en": "glimepiride" }, "value": 1, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "1 mg 是每片标签标示量；不是个人片数、频率或换算指令", "en": "1 mg is a labelled amount per tablet; not an individual's tablet count, frequency or conversion instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "片", "en": "tablets" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-23", "currentLabelDisplayed": false, "ndcDirectoryListed": true, "marketAvailability": "historical_label_record_only", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "粉红色", "en": "pink" }, "shape": { "zh": "扁平椭圆片；两处刻痕（外观线索不是分片指令）", "en": "flat oval tablet with two score marks (an appearance clue, not a splitting instruction)" }, "imprint": "AMA RYL", "scoreStatus": "double-bisect", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_fd98f66cc8626b48", "label": "DailyMed（NLM）：AMARYL 格列美脲美国历史公开标签（Sanofi-Aventis；2018-12 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/downloadpdffile.cfm?setId=222b630b-7e09-43b4-9894-3d87f10add91", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-amaryl-glimepiride-tablet-2mg-100-bottle-ndc-0039022210-historical", "marketCode": "US", "labelVersion": { "zh": "DailyMed 美国历史公开标签（Sanofi-Aventis；2018-12 修订；标签记录美国营销终止于 2023-08-31）", "en": "U.S. DailyMed historical public label (Sanofi-Aventis; revised Dec 2018; label records U.S. marketing ended 31 Aug 2023)" }, "dosageForm": { "zh": "AMARYL 格列美脲口服片（历史美国标签）", "en": "AMARYL glimepiride oral tablet (historical U.S. label)" }, "route": { "zh": "口服（历史标签产品身份字段）", "en": "oral (historical-label product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 0039-0222-10", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片格列美脲 2 mg；100 片瓶装（美国历史标签）", "en": "Glimepiride 2 mg per tablet; 100-tablet bottle (historical U.S. label)" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "格列美脲", "en": "glimepiride" }, "value": 2, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "2 mg 是每片标签标示量；不是个人片数、频率或换算指令", "en": "2 mg is a labelled amount per tablet; not an individual's tablet count, frequency or conversion instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "片", "en": "tablets" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-23", "currentLabelDisplayed": false, "ndcDirectoryListed": true, "marketAvailability": "historical_label_record_only", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "绿色", "en": "green" }, "shape": { "zh": "扁平椭圆片；两处刻痕（外观线索不是分片指令）", "en": "flat oval tablet with two score marks (an appearance clue, not a splitting instruction)" }, "imprint": "AMA RYL", "scoreStatus": "double-bisect", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_fd98f66cc8626b48", "label": "DailyMed（NLM）：AMARYL 格列美脲美国历史公开标签（Sanofi-Aventis；2018-12 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/downloadpdffile.cfm?setId=222b630b-7e09-43b4-9894-3d87f10add91", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-amaryl-glimepiride-tablet-4mg-100-bottle-ndc-0039022310-historical", "marketCode": "US", "labelVersion": { "zh": "DailyMed 美国历史公开标签（Sanofi-Aventis；2018-12 修订；标签记录美国营销终止于 2023-08-31）", "en": "U.S. DailyMed historical public label (Sanofi-Aventis; revised Dec 2018; label records U.S. marketing ended 31 Aug 2023)" }, "dosageForm": { "zh": "AMARYL 格列美脲口服片（历史美国标签）", "en": "AMARYL glimepiride oral tablet (historical U.S. label)" }, "route": { "zh": "口服（历史标签产品身份字段）", "en": "oral (historical-label product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 0039-0223-10", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片格列美脲 4 mg；100 片瓶装（美国历史标签）", "en": "Glimepiride 4 mg per tablet; 100-tablet bottle (historical U.S. label)" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "格列美脲", "en": "glimepiride" }, "value": 4, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "4 mg 是每片标签标示量；不是个人片数、频率或换算指令", "en": "4 mg is a labelled amount per tablet; not an individual's tablet count, frequency or conversion instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "片", "en": "tablets" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-23", "currentLabelDisplayed": false, "ndcDirectoryListed": true, "marketAvailability": "historical_label_record_only", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "蓝色", "en": "blue" }, "shape": { "zh": "扁平椭圆片；两处刻痕（外观线索不是分片指令）", "en": "flat oval tablet with two score marks (an appearance clue, not a splitting instruction)" }, "imprint": "AMA RYL", "scoreStatus": "double-bisect", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_fd98f66cc8626b48", "label": "DailyMed（NLM）：AMARYL 格列美脲美国历史公开标签（Sanofi-Aventis；2018-12 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/downloadpdffile.cfm?setId=222b630b-7e09-43b4-9894-3d87f10add91", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "status": "withheld_repackaged_or_non_exact_visual", "title": { "zh": "已核验历史美国标签文字，但未保留可一一对应的官方包装图，故不展示包装图片", "en": "Historical U.S. label text was reviewed, but no one-to-one official package image was retained, so no package visual is shown" }, "summary": { "zh": "本档案保留 DailyMed 历史公开标签中 AMARYL、格列美脲、1 mg／2 mg／4 mg、三个 NDC、100 片瓶装、片剂颜色与刻痕文字，并明确该三种美国产品记录的营销终止日期为 2023-08-31。该 PDF 包含瓶身展示文字，但本轮未保留一个经逐一核对、可安全作为准确历史包装图公开展示的独立图像资源；为避免把历史图误读为当前在售、其他市场或可用于真伪判断的药盒，本页不展示包装图片，只保留可放大阅读的一手标签。", "en": "This dossier retains AMARYL, glimepiride, 1 mg/2 mg/4 mg, three NDCs, 100-tablet bottles, color and score-mark wording from a DailyMed historical public label, which records U.S. marketing end for all three products on 31 Aug 2023. The PDF includes bottle display text, but this review did not retain a separately verified image safe to present as an exact historical pack; to avoid reading a historical image as current marketing, another-market packaging or a means of authentication, the page shows no package image and retains the primary label for enlarged reading." }, "source": { "id": "src_fd98f66cc8626b48", "label": "DailyMed（NLM）：AMARYL 格列美脲美国历史公开标签（Sanofi-Aventis；2018-12 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/downloadpdffile.cfm?setId=222b630b-7e09-43b4-9894-3d87f10add91", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "AMARYL 历史说明书放大阅读：先认清 1／2／4 mg 与历史市场状态", "en": "AMARYL historical-label reading: identify 1/2/4 mg and the historical market record first" }, "summary": { "zh": "本模块只阅读 Sanofi-Aventis 的美国历史标签：AMARYL、格列美脲、1/2/4 mg 每片、三个 NDC、100 片瓶装与 2023-08-31 的美国营销终止记录。它不提供个人血糖处理、片数、漏用、分片、进餐、加药、停药、与其他降糖药联用或换药方案。", "en": "This module reads only Sanofi-Aventis' U.S. historical label: AMARYL, glimepiride, 1/2/4 mg per tablet, three NDCs, 100-tablet bottles and the U.S. marketing-end record of 31 Aug 2023. It does not provide individual glucose management, tablet count, missed-use, splitting, meals, add-on therapy, stopping, co-use with another glucose-lowering medicine or switching plans." }, "checks": [ { "zh": "先同时核对 AMARYL、格列美脲、1/2/4 mg、NDC、100 片瓶装和市场。mg 是这一历史标签中每片的标示量；不是网页可换算成每天几片、把两种强度相加或在其他降糖药之间替代的规则。", "en": "Check AMARYL, glimepiride, 1/2/4 mg, NDC, the 100-tablet bottle and market together. mg is a labelled amount per tablet in this historical label, not a web rule for tablets per day, adding strengths or replacing another glucose-lowering medicine." }, { "zh": "该历史标签描述三种片剂都有两处刻痕。刻痕和颜色是药盒/药片核对线索，不是自行掰开、调量、混用或以另一强度替代的指令；历史标签也不能外推到仿制片、其他市场或当前产品。", "en": "This historical label describes two score marks on all three tablets. Score marks and color are pack/tablet checking clues, not instructions to self-split, change use, combine products or substitute another strength; the historical label also cannot be extended to a generic tablet, another market or a current product." }, { "zh": "标签对低血糖、严重过敏反应、G6PD 缺乏相关溶血性贫血及多种相互作用给出警示；老年人、肾功能受损或合并其他降糖药的人尤其需要让了解完整病史和药单的专业团队核对。页面不据此决定任何人继续、暂停、补用或改变治疗。", "en": "The label warns about hypoglycemia, serious hypersensitivity, hemolytic anemia related to G6PD deficiency and multiple interactions; older people, people with renal impairment or people using another glucose-lowering medicine especially need review by a professional who knows the complete history and medicine list. This page does not decide continuation, pausing, make-up use or a treatment change for anyone." }, { "zh": "疑似低血糖、意识改变、抽搐、严重过敏表现或其他急性严重不适，应使用当地紧急与医疗渠道；不要依照本页自行补糖、补药、停药或调整。", "en": "For suspected hypoglycemia, altered consciousness, seizure, serious allergic features or another acute serious concern, use local urgent and medical pathways; do not self-treat with sugar, make up medicine, stop or adjust based on this page." } ], "source": { "id": "src_fd98f66cc8626b48", "label": "DailyMed（NLM）：AMARYL 格列美脲美国历史公开标签（Warnings, interactions and product identity）", "url": "https://dailymed.nlm.nih.gov/dailymed/downloadpdffile.cfm?setId=222b630b-7e09-43b4-9894-3d87f10add91", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "格列美脲怎样起作用：促进胰岛 β 细胞释放胰岛素", "en": "How glimepiride works: it stimulates insulin release from pancreatic beta cells" }, "summary": { "zh": "该历史标签将格列美脲描述为主要通过刺激胰岛 β 细胞释放胰岛素来降低血糖；磺脲类与 β 细胞膜上的磺脲受体结合，继而影响 ATP 敏感性钾通道。这是作用路径的说明，不是任何个人血糖目标、片数、适用性、联用或换药方案。", "en": "This historical label describes glimepiride as primarily lowering blood glucose by stimulating insulin release from pancreatic beta cells; sulfonylureas bind the beta-cell sulfonylurea receptor and then affect the ATP-sensitive potassium channel. This explains a pathway, not an individual's glucose target, tablet count, suitability, co-use or switching plan." }, "checks": [ { "zh": "“促进胰岛素释放”解释了为何需要严肃对待低血糖风险，但不表示网页可判断任何人该吃多少、该与胰岛素/二甲双胍/其他降糖药如何合用或何时停用。", "en": "‘Stimulating insulin release’ explains why hypoglycemia risk needs serious attention, but does not let a webpage decide how much anyone should use, how to combine it with insulin/metformin/another glucose-lowering medicine or when to stop." }, { "zh": "同为降糖药、名称相近、血糖读数变化或包装上都有 mg，均不能证明产品可以自行叠加、轮换、补用或替换。应带上全部处方药、非处方药、补充剂和实际产品让药师或开方团队逐项核对。", "en": "Being glucose-lowering medicines, having similar names, a changing glucose reading or mg on both packages does not establish that products can be self-combined, alternated, made up or replaced. Bring all prescription medicines, OTC products, supplements and actual packs for item-by-item pharmacist or prescriber review." }, { "zh": "本历史美国标签的机制资料不能建立其他市场的产品状态，也不能替代当前标签、血糖监测计划、饮食/活动建议或个体化治疗。", "en": "This historical U.S. label's mechanism material does not establish product status in another market and cannot replace a current label, glucose-monitoring plan, diet/activity advice or individualised care." } ], "source": { "id": "src_fd98f66cc8626b48", "label": "DailyMed（NLM）：AMARYL 格列美脲美国历史公开标签（Clinical Pharmacology）", "url": "https://dailymed.nlm.nih.gov/dailymed/downloadpdffile.cfm?setId=222b630b-7e09-43b4-9894-3d87f10add91", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "Amaryl", "generic": "格列美脲", "dosageFormClass": "格列美脲口服片：1 mg、2 mg、4 mg（历史美国标签所列；各 100 片瓶装）" }, "labelSource": { "id": "src_fd98f66cc8626b48", "label": "DailyMed（NLM）：AMARYL 格列美脲美国历史公开标签（Sanofi-Aventis；2018-12 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/downloadpdffile.cfm?setId=222b630b-7e09-43b4-9894-3d87f10add91", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "productRoutes": [ { "source": { "id": "src_fd98f66cc8626b48", "label": "DailyMed（NLM）：AMARYL 格列美脲美国历史公开标签（Sanofi-Aventis；2018-12 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/downloadpdffile.cfm?setId=222b630b-7e09-43b4-9894-3d87f10add91", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-23", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-23", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "DailyMed 的 AMARYL（glimepiride）历史美国标签列出 1 mg、2 mg、4 mg 口服片及各自 100 片瓶装、NDC 与外观线索；该同一标签记录三种产品在美国的营销终止日期为 2023-08-31。本页帮助读者辨认历史药盒与阅读一手资料，不把 mg、包装数字、刻痕或“降糖药”类别转换为个人片数、加减、联用、替换、停用或购买结论。", "history": "该档案以 DailyMed 的 2018-12 修订历史标签为唯一产品身份锚点。标签列示 Initial U.S. Approval: 1995、NDA 020496，并分别记录 NDC 0039-0221-10、0039-0222-10、0039-0223-10 的美国营销终止日期为 2023-08-31。它不能说明今天任何地点的库存、批准、可售、医保、是否为原研或能否与其他格列美脲/其他降糖产品互换。", "sourceDocuments": [ { "id": "src_fd98f66cc8626b48", "label": "DailyMed（NLM）：AMARYL 格列美脲美国历史公开标签（Sanofi-Aventis；2018-12 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/downloadpdffile.cfm?setId=222b630b-7e09-43b4-9894-3d87f10add91", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, { "id": "src_5ed30b676fbb9773", "label": "FDA Drugs@FDA 官方检索入口（NDA 020496）", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_lookup_entry", "documentKind": "regulatory_lookup", "market": "US", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } ], "applicationNumber": "NDA 020496（历史美国标签产品记录）", "approvalTimeline": [ { "date": "1995", "title": { "zh": "历史标签所列美国初始批准年份", "en": "Initial U.S. approval year listed in the historical label" }, "detail": { "zh": "DailyMed 的 AMARYL 历史美国标签列示 Initial U.S. Approval: 1995。这只定位所引美国历史档案，不建立中国大陆、欧盟、日本或其他市场的批准、供应、可售资格、原研/仿制关系或个人适用性。", "en": "The AMARYL U.S. historical DailyMed label lists Initial U.S. Approval: 1995. This locates only the cited U.S. historical archive and does not establish approval, supply, sale eligibility, originator/generic relationship or individual suitability in Mainland China, the EU, Japan or another market." }, "source": { "id": "src_fd98f66cc8626b48", "label": "DailyMed（NLM）：AMARYL 格列美脲美国历史公开标签（Sanofi-Aventis；2018-12 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/downloadpdffile.cfm?setId=222b630b-7e09-43b4-9894-3d87f10add91", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" } }, { "date": "2018-12", "title": { "zh": "历史公开标签修订", "en": "Historical public-label revision" }, "detail": { "zh": "所引 AMARYL 标签标示为 2018-12 修订。该日期只标识文件版本，不能代表当前标签、当前安全结论、库存、购买资格或其他市场状态。", "en": "The cited AMARYL label is marked revised Dec 2018. The date identifies only the document version and does not represent current labelling, current safety conclusions, stock, purchase eligibility or another-market status." }, "source": { "id": "src_fd98f66cc8626b48", "label": "DailyMed（NLM）：AMARYL 格列美脲美国历史公开标签（Sanofi-Aventis；2018-12 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/downloadpdffile.cfm?setId=222b630b-7e09-43b4-9894-3d87f10add91", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" } }, { "date": "2023-08-31", "title": { "zh": "历史产品记录列示美国营销终止日期", "en": "U.S. marketing-end date listed in historical product data" }, "detail": { "zh": "同一历史公开标签的三个 NDC 产品记录均列示 2023-08-31 为美国营销终止日期。因此本页不将 AMARYL 表述为当前在售、可购、可替代或仍在美国供应；现行产品问题须回到目标市场的现行官方资料与专业人员。", "en": "All three NDC product records in the same historical public label list 31 Aug 2023 as a U.S. marketing-end date. This page therefore does not describe AMARYL as currently marketed, purchasable, interchangeable or still supplied in the United States; current-product questions require current target-market official material and a professional." }, "source": { "id": "src_fd98f66cc8626b48", "label": "DailyMed（NLM）：AMARYL 格列美脲美国历史公开标签（NDC 0039-0221/0222/0223；营销终止记录）", "url": "https://dailymed.nlm.nih.gov/dailymed/downloadpdffile.cfm?setId=222b630b-7e09-43b4-9894-3d87f10add91", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "历史产品记录列示三个 NDC 于 2023-08-31 营销终止", "en": "Historical product records list marketing ended for three NDCs on 31 Aug 2023" }, "detail": { "zh": "本页只保留 AMARYL 格列美脲 1 mg、2 mg、4 mg、三个 NDC 与 100 片瓶装的历史标签身份和原始文件入口；不建立当前在售、库存、购买、换用或供应结论。", "en": "This page retains only the historical-label identity and primary-document entry point for AMARYL glimepiride 1 mg, 2 mg and 4 mg, the three NDCs and 100-tablet bottles; it does not establish current marketing, stock, purchase, switching or supply." } }, { "market": { "zh": "中国大陆、欧盟、日本及其他市场", "en": "Mainland China, EU, Japan and other markets" }, "status": { "zh": "待逐项建立现行市场记录", "en": "Current market record not established" }, "detail": { "zh": "不从这份美国历史标签推定当地商品名、批准、包装、供应、可售资格、原研/仿制关系或可替代性；每个市场须按当地现行监管资料单独核对。", "en": "No local trade name, approval, packaging, supply, sale eligibility, originator/generic relationship or interchangeability is inferred from this U.S. historical label; each market needs separate checking against current local regulatory material." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "AMARYL 的 1、2、4 mg、100 片瓶装和历史刻痕能否用来决定今天怎样服、怎么掰或换另一种降糖药？", "en": "Can AMARYL's historical 1, 2 and 4 mg strengths, 100-tablet bottles and score marks decide how to use it today, split it or change to another glucose-lowering medicine?" }, "answer": { "zh": "不能。这些资料只识别所引美国历史标签中的准确片剂与瓶装，且三个 NDC 已被该标签记录为美国营销终止。共同通用名、相近 mg、颜色、刻痕或包装文字均不建立自行开始、增加、重复、掰开、停用、联用、轮换或替换关系；请将现行药盒、处方和完整药单交由药师或开方团队复核。", "en": "No. These details identify only the exact tablets and bottles in the cited U.S. historical label, whose three NDCs are recorded as marketing-ended in the United States. A shared generic name, similar mg number, color, score marks or package wording does not establish self-initiation, increase, repetition, splitting, stopping, co-use, alternation or substitution; have a pharmacist or prescribing team review the current pack, prescription and complete medicine list." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "dosage-forms-are-part-of-medicine-identity", "how-to-read-a-drug-label" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/amaryl/", "en": "https://origindrug.com/en/drugs/amaryl/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "januvia", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-21", "status": "published_traceable_archive" }, "names": { "brand": "Januvia", "generic": "西格列汀", "aliases": [ "sitagliptin" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "代谢", "sourceArchiveMarket": "美国 DailyMed 有日期公开标签（页面 2024-11-14 更新；本档案分别展示三种 30 片瓶装面板）", "dosageFormClass": "西格列汀口服薄膜衣片：25 mg、50 mg、100 mg（DailyMed 页面 2024-11-14 更新；本档案分别展示三种 30 片瓶装面板）", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "2006（FDA 标签所列美国初始批准）", "archiveSponsorText": "FDA 公开监管档案" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [ "JANUMET", "STEGLUJAN" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-januvia-sitagliptin-tablet-25mg-0006022131", "marketCode": "US", "labelVersion": { "zh": "DailyMed 页面 2024-11-14 更新的公开标签", "en": "public DailyMed label page updated 14 Nov 2024" }, "dosageForm": { "zh": "西格列汀口服薄膜衣片", "en": "sitagliptin oral film-coated tablet" }, "route": { "zh": "口服（仅作标签产品身份字段）", "en": "oral (label product-identity field only)" }, "routeCodes": [ "oral" ], "productCode": "NDC 0006-0221-31", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片 25 mg；30 片瓶装", "en": "25 mg per tablet; 30-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=januvia-04.jpg&setid=f85a48d0-0407-4c50-b0fa-7673a160bf01&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "西格列汀", "en": "sitagliptin" }, "value": 25, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人服用片数、加减、补服、换药或换算指令", "en": "labelled amount per tablet; not an individual tablet count, adjustment, make-up, switching or conversion instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "单位使用瓶", "en": "unit-of-use bottle" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-21", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 30, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "粉红色", "en": "pink" }, "shape": { "zh": "圆形", "en": "round" }, "imprint": "221", "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_bb3cec99dda1d675", "label": "DailyMed（NLM）：JANUVIA 西格列汀 25 mg、30 片瓶装美国公开标签面板（Merck；页面 2024-11-14 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=f85a48d0-0407-4c50-b0fa-7673a160bf01", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-januvia-sitagliptin-tablet-50mg-0006011231", "marketCode": "US", "labelVersion": { "zh": "DailyMed 页面 2024-11-14 更新的公开标签", "en": "public DailyMed label page updated 14 Nov 2024" }, "dosageForm": { "zh": "西格列汀口服薄膜衣片", "en": "sitagliptin oral film-coated tablet" }, "route": { "zh": "口服（仅作标签产品身份字段）", "en": "oral (label product-identity field only)" }, "routeCodes": [ "oral" ], "productCode": "NDC 0006-0112-31", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片 50 mg；30 片瓶装", "en": "50 mg per tablet; 30-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=januvia-05.jpg&setid=f85a48d0-0407-4c50-b0fa-7673a160bf01&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "西格列汀", "en": "sitagliptin" }, "value": 50, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人服用片数、加减、补服、换药或换算指令", "en": "labelled amount per tablet; not an individual tablet count, adjustment, make-up, switching or conversion instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "单位使用瓶", "en": "unit-of-use bottle" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-21", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 30, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "浅米色", "en": "light beige" }, "shape": { "zh": "圆形", "en": "round" }, "imprint": "112", "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_bb3cec99dda1d675", "label": "DailyMed（NLM）：JANUVIA 西格列汀 50 mg、30 片瓶装美国公开标签面板（Merck；页面 2024-11-14 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=f85a48d0-0407-4c50-b0fa-7673a160bf01", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-januvia-sitagliptin-tablet-100mg-0006027731", "marketCode": "US", "labelVersion": { "zh": "DailyMed 页面 2024-11-14 更新的公开标签", "en": "public DailyMed label page updated 14 Nov 2024" }, "dosageForm": { "zh": "西格列汀口服薄膜衣片", "en": "sitagliptin oral film-coated tablet" }, "route": { "zh": "口服（仅作标签产品身份字段）", "en": "oral (label product-identity field only)" }, "routeCodes": [ "oral" ], "productCode": "NDC 0006-0277-31", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片 100 mg；30 片瓶装", "en": "100 mg per tablet; 30-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=januvia-06.jpg&setid=f85a48d0-0407-4c50-b0fa-7673a160bf01&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "西格列汀", "en": "sitagliptin" }, "value": 100, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人服用片数、加减、补服、换药或换算指令", "en": "labelled amount per tablet; not an individual tablet count, adjustment, make-up, switching or conversion instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "单位使用瓶", "en": "unit-of-use bottle" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-21", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 30, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "米色", "en": "beige" }, "shape": { "zh": "圆形", "en": "round" }, "imprint": "277", "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_bb3cec99dda1d675", "label": "DailyMed（NLM）：JANUVIA 西格列汀 100 mg、30 片瓶装美国公开标签面板（Merck；页面 2024-11-14 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=f85a48d0-0407-4c50-b0fa-7673a160bf01", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-januvia-sitagliptin-tablet-25mg-0006022131", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=januvia-04.jpg&setid=f85a48d0-0407-4c50-b0fa-7673a160bf01&type=img", "alt": "JANUVIA 25 mg 片剂在美国 DailyMed 公开标签中的包装主展示图", "archiveMarket": "美国", "labelVersion": "2024-11", "presentation": "JANUVIA 25 mg 片剂瓶装主展示面（DailyMed 页面所列 2024-11 更新标签）", "notice": "此为美国 DailyMed 公开标签中的包装文字图，只帮助核对 JANUVIA、通用名、标示强度和口服片剂线索；不用于鉴定真伪，也不证明原研身份、当前包装、目标市场批准或可售资格。", "source": { "id": "src_bb3cec99dda1d675", "label": "DailyMed（NLM）：JANUVIA 公开标签（2024-11 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=f85a48d0-0407-4c50-b0fa-7673a160bf01", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "JANUVIA 说明书放大阅读：25 mg、50 mg、100 mg 不是自行选用的级别", "en": "JANUVIA label reading: 25 mg, 50 mg and 100 mg are not levels to self-select" }, "summary": { "zh": "本模块以 DailyMed 公开标签为阅读入口，帮助理解 JANUVIA 片剂上不同 mg 标示均是产品强度，且标签对某些肾功能情况有专门章节；它不替代肾功能评估或个人处方。", "en": "This module uses the public DailyMed label as a reading entry point. It explains that different mg markings on JANUVIA tablets are product strengths and that the label has a dedicated section for some kidney-function situations; it does not replace kidney-function assessment or an individual prescription." }, "checks": [ { "zh": "该美国公开标签列有 25 mg、50 mg、100 mg 片剂。每个数字首先表示该片标示的西格列汀产品强度；不能把不同颜色、不同 mg 或不同市场包装当成可以自行换算、拼凑或轮换的答案。", "en": "The U.S. public label lists 25 mg, 50 mg and 100 mg tablets. Each number first identifies the stated sitagliptin product strength; different colours, milligram markings or market packages are not answers a person can independently convert, combine or alternate." }, { "zh": "标签含有肾功能相关的给药章节，说明肾功能信息是处方核对的一部分，而不是读者依据网页自行挑选规格的依据。若近期化验、病情或其他药物改变，应以开方团队或药师复核为准。", "en": "The label contains a kidney-function dosing section, showing that kidney information belongs in prescription review rather than self-selection of a strength from a webpage. If recent tests, health status or other medicines change, use a prescribing team or pharmacist for review." }, { "zh": "与胰岛素或促胰岛素分泌药等联用、出现疑似不良反应，或考虑从另一种降糖药转换时，应带完整药单核对。不要因为商品名相似或看到“降糖”字样而自行叠加或替代。", "en": "When insulin or an insulin secretagogue is also used, a possible adverse reaction occurs, or a change from another glucose-lowering medicine is being considered, bring the complete medicine list for review. Do not self-add or substitute based on a similar brand name or the word “glucose lowering.”" }, { "zh": "药盒图片、颜色和数字不能证明真伪，也不能说明当前市场的批准、供应或适用人群。请以所在市场的现行官方文件及实际包装信息为准。", "en": "Package images, colours and numbers cannot authenticate a product or establish current approval, supply or eligible population in a market. Use the current official documents and actual package information for the intended market." } ], "source": { "id": "src_7697767980bbe895", "label": "DailyMed（NLM）：JANUVIA 公开标签（2024-11 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=f85a48d0-0407-4c50-b0fa-7673a160bf01", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "西格列汀怎样起作用：它抑制 DPP-4，延长肠促胰岛素激素的作用", "en": "How sitagliptin works: it inhibits DPP-4 and prolongs incretin-hormone activity" }, "summary": { "zh": "FDA 标签说明，西格列汀通过抑制 DPP-4 减慢肠促胰岛素激素的失活，从而增加活性 GLP-1 和 GIP 的水平；标签将这些变化与葡萄糖依赖性的胰岛素释放和胰高血糖素调节联系起来。它解释的是一条药理路径，不判断个人血糖、肾功能、剂量、是否适用或是否应换药。", "en": "The FDA label explains that sitagliptin inhibits DPP-4, slowing incretin-hormone inactivation and increasing active GLP-1 and GIP; it links these changes with glucose-dependent insulin release and glucagon regulation. This explains a pharmacologic pathway, not an individual's glucose, kidney function, dose, suitability or whether to switch medicines." }, "checks": [ { "zh": "“与 GLP-1/GIP 有关”不表示 JANUVIA 能与任何 GLP-1、GIP、胰岛素或其他降糖产品自行叠加、替换或轮换，也不表示两种产品一起使用会“更强”。产品、给药途径、完整药单和具体情形都需由专业人员核对。", "en": "“Related to GLP-1/GIP” does not make JANUVIA self-combinable, substitutable or alternatable with any GLP-1, GIP, insulin or other glucose-lowering product, nor show that two products together will be “stronger.” Product, route, complete medicine list and the specific context all need professional review." }, { "zh": "机制不能把 25 mg、50 mg、100 mg 或不同包装上的数字变成自行选用、合并或换算规则。尤其涉及肾功能资料、旧处方或换药时，应以准确产品的现行标签和开方团队复核为准。", "en": "Mechanism cannot turn 25 mg, 50 mg, 100 mg or numbers on different packages into self-selection, combination or conversion rules. Especially with kidney-function information, an older prescription or a medicine change, use the current label for the exact product and the prescribing team for review." }, { "zh": "出现低血糖相关不适、过敏样症状，或正在同时使用可能影响血糖的其他产品时，不应从机制页面自行增减或停用任何一件药。请带实际包装和完整药单取得当地药师、医生或紧急支持。", "en": "With symptoms related to low glucose, allergy-like symptoms, or concurrent use of another product that may affect glucose, do not increase, reduce or stop any medicine from this mechanism page. Bring the actual packages and complete medicine list to local pharmacist, clinician or urgent support." } ], "source": { "id": "src_df65df171e9d77ab", "label": "FDA：JANUVIA 2022 美国处方信息（临床药理）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021995s050lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "Januvia", "generic": "西格列汀", "dosageFormClass": "西格列汀口服薄膜衣片：25 mg、50 mg、100 mg（DailyMed 页面 2024-11-14 更新；本档案分别展示三种 30 片瓶装面板）" }, "labelSource": { "id": "src_7697767980bbe895", "label": "DailyMed（NLM）：JANUVIA 公开标签（2024-11 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=f85a48d0-0407-4c50-b0fa-7673a160bf01", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "productRoutes": [ { "source": { "id": "src_7697767980bbe895", "label": "DailyMed（NLM）：JANUVIA 公开标签（2024-11 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=f85a48d0-0407-4c50-b0fa-7673a160bf01", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_dd50b9ff5e82c75b", "label": "FDA：JANUVIA 2015-08 美国标签档案（NDA 021995）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021995s034lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "美国 DailyMed 的 JANUVIA（sitagliptin）有日期公开标签列有 25 mg、50 mg、100 mg 口服薄膜衣片；本页分别建立三个 30 片瓶装面板的品牌、通用名、每片强度、NDC、外观线索和来源核对卡。它不把包装数字变成个人片数、加减、补服、停用、换药或联用方案，也不据此推定原研关系、目标市场批准、供应或销售资格。", "history": "FDA 历史标签记录其美国初始批准年份为 2006。本页的三个包装面板只对应 DailyMed 页面 2024-11-14 更新时所列的 JANUVIA 25 mg、50 mg、100 mg、30 片瓶装；JANUMET 与 STEGLUJAN 等含西格列汀的复方产品不能按品牌或成分重叠并入本单方片剂档案。", "sourceDocuments": [ { "id": "src_dd50b9ff5e82c75b", "label": "FDA：JANUVIA 2015-08 美国标签档案（NDA 021995）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021995s034lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_7697767980bbe895", "label": "DailyMed（NLM）：JANUVIA 公开标签（2024-11 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=f85a48d0-0407-4c50-b0fa-7673a160bf01", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_5ed30b676fbb9773", "label": "FDA Drugs@FDA 官方检索入口", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_lookup_entry", "documentKind": "regulatory_lookup", "market": "US", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } ], "applicationNumber": "NDA 021995", "approvalTimeline": [ { "date": "2006", "title": { "zh": "FDA 标签所列美国初始批准年份", "en": "Initial U.S. approval year listed in the FDA label" }, "detail": { "zh": "本页链接的 FDA 标签档案列示 Initial U.S. Approval: 2006。该历史定位不等同于当前批准、可得性、持有人或其他市场状态。", "en": "The FDA label archive linked here lists Initial U.S. Approval: 2006. This historical locator is not a conclusion about current approval, availability, holder or another market." }, "source": { "id": "src_dd50b9ff5e82c75b", "label": "FDA: JANUVIA label archive", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021995s034lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, { "date": "2015-08", "title": { "zh": "FDA 标签档案版本", "en": "FDA label archive version" }, "detail": { "zh": "本页链接 2015-08 的 FDA 标签档案作为可复核阅读入口。现行标签、规格、适应症和安全信息必须另行以目标市场当前文件核对。", "en": "This page links the 2015-08 FDA label archive as a traceable reading entry point. Current labeling, strength, indication and safety information require separate verification against the target market’s current document." }, "source": { "id": "src_dd50b9ff5e82c75b", "label": "FDA: JANUVIA label archive", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021995s034lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "已链接公开标签档案", "en": "Public label archive linked" }, "detail": { "zh": "仅对应本页所列 FDA 文件。", "en": "Only the FDA document listed on this page is linked." } }, { "market": { "zh": "中国大陆、欧盟、日本", "en": "Mainland China, EU, Japan" }, "status": { "zh": "待逐项建立市场记录", "en": "Market record not established" }, "detail": { "zh": "不从美国标签档案推定当地批准、持有人、规格、供应或可售资格。", "en": "No local approval, holder, strength, supply or sale-eligibility conclusion is inferred from the U.S. label archive." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "标签档案能代表现在的产品信息吗？", "en": "Does a label archive represent current product information?" }, "answer": { "zh": "不能自动代表。档案用于定位来源；需要以目标市场的现行官方标签逐项复核。", "en": "Not automatically. The archive locates a source; each point needs verification against the target market’s current official label." } }, { "question": { "zh": "为什么这里不展示价格或原研/仿制结论？", "en": "Why are price and originator/generic conclusions not shown?" }, "answer": { "zh": "这些结论需要产品、剂型、规格、包装、市场、日期和原始记录分别齐全并经人工审核；单一标签文件不足以支持。", "en": "Those conclusions require separately complete and human-reviewed product, dosage-form, strength, pack, market, date and primary-record fields; one label file is insufficient." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "how-to-read-a-drug-label", "regulatory-sources-first" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/januvia/", "en": "https://origindrug.com/en/drugs/januvia/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "tradjenta", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-22", "status": "published_traceable_archive" }, "names": { "brand": "Tradjenta", "generic": "利格列汀", "aliases": [ "linagliptin", "利格列汀", "トラゼンタ" ], "marketBrandNames": [ { "name": "トラゼンタ", "market": { "zh": "日本", "en": "Japan" }, "evidenceStatus": "current_regulatory_record", "note": { "zh": "PMDA 当前产品页列示トラゼンタ錠 5 mg及利格列汀成分；仅用于核对日文名称、成分、片剂和市场记录。", "en": "The current PMDA product page lists TRADJENTA (トラゼンタ) 5 mg tablets with linagliptin; it supports checking the Japanese name, ingredient, tablet form and market record only." }, "source": { "id": "src_6b0b4b744953ccf8", "label": "PMDA: TRADJENTA 5 mg current product record (Japan)", "url": "https://www.pmda.go.jp/PmdaSearch/rdDetail/iyaku/3969014F1024_1?user=1", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } } ], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "代谢", "sourceArchiveMarket": "美国 DailyMed 公开标签；日本 PMDA 当前产品记录（トラゼンタ錠 5 mg）。不同市场说明书、包装和状态必须分别核对。", "dosageFormClass": "口服薄膜衣片：5 mg（公开标签产品身份信息）", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "2011（FDA 标签所列美国初始批准）", "archiveSponsorText": "Boehringer Ingelheim / FDA、DailyMed 与 PMDA 公开监管记录" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-tradjenta-linagliptin-5mg-100tablet-blister-card-carton-ndc-0597-0140-61", "marketCode": "US", "labelVersion": { "zh": "DailyMed 美国公开标签（处方信息 2023-06 修订）", "en": "U.S. DailyMed public label (prescribing information revised Jun 2023)" }, "dosageForm": { "zh": "利格列汀口服薄膜衣片", "en": "linagliptin film-coated oral tablet" }, "route": { "zh": "口服（标签产品身份字段）", "en": "oral (label product-identity field only)" }, "routeCodes": [ "oral" ], "productCode": "NDC 0597-0140-61", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "TRADJENTA 利格列汀每片 5 mg；100 片纸盒（10 张泡罩卡 × 10 片；NDC 0597-0140-61）", "en": "TRADJENTA linagliptin 5 mg per tablet; 100-tablet carton (10 blister cards × 10; NDC 0597-0140-61)" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=tradjenta-05.jpg&setid=c797ea5c-cab7-494b-9044-27eba0cfe40f&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "利格列汀", "en": "linagliptin" }, "value": 5, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、加减、补服、联用或换药指令", "en": "labelled amount per tablet; not an individual tablet count, adjustment, make-up, co-use or switching instruction" } } ], "concentration": null, "container": { "typeCode": "blister_card_carton", "typeLabel": { "zh": "泡罩卡纸盒", "en": "blister-card carton" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "片/盒", "en": "tablets per carton" }, "unitsPerContainer": { "count": 10, "unit": { "zh": "片/泡罩卡", "en": "tablets per blister card" } } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-22", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "片/纸盒", "en": "tablets per carton" } }, "physicalClues": { "color": { "zh": "浅红色（以此美国标签纸盒及实际片剂为准）", "en": "light red (refer to this U.S. label carton and actual tablet)" }, "shape": { "zh": "圆形双凸、斜边薄膜衣片；纸盒含 10 张泡罩卡", "en": "round biconvex, bevel-edged film-coated tablet; carton contains 10 blister cards" }, "imprint": "D5 / Boehringer Ingelheim symbol", "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_ce041faec8321ea2", "label": "DailyMed（NLM）：TRADJENTA 利格列汀 5 mg 泡罩卡纸盒美国公开标签面板（Boehringer Ingelheim；处方信息 2023-06 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=c797ea5c-cab7-494b-9044-27eba0cfe40f&type=display", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-tradjenta-linagliptin-5mg-100tablet-blister-card-carton-ndc-0597-0140-61", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=tradjenta-05.jpg&setid=c797ea5c-cab7-494b-9044-27eba0cfe40f&type=img", "alt": "TRADJENTA 利格列汀 5 mg、NDC 0597-0140-61、100 片泡罩卡纸盒在美国 DailyMed 公开标签中的主展示面", "archiveMarket": "美国", "labelVersion": "DailyMed 美国公开标签（处方信息 2023-06 修订）", "presentation": "TRADJENTA 利格列汀：每片 5 mg，NDC 0597-0140-61，100 片纸盒（10 张泡罩卡 × 10 片）。", "notice": "此图只对应美国 DailyMed 公开标签中的 TRADJENTA、利格列汀、每片 5 mg、NDC 0597-0140-61 与 100 片泡罩卡纸盒。它只帮助核对品牌、通用名、每片标示量、剂型、包装和来源；不用于鉴定真伪，也不证明 30 片或 90 片瓶装、7 片纸盒、其他市场、当前可得性、原研身份、可替代性，或任何个人的片数、开始、停用、联用或换药方案。", "source": { "id": "src_ce041faec8321ea2", "label": "DailyMed（NLM）：TRADJENTA 利格列汀 5 mg 泡罩卡纸盒美国公开标签面板（Boehringer Ingelheim；处方信息 2023-06 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=c797ea5c-cab7-494b-9044-27eba0cfe40f&type=display", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "TRADJENTA 说明书放大阅读：5 mg 先是片剂身份，不是个人片数", "en": "TRADJENTA label reading: 5 mg identifies the tablet first; it is not an individual's tablet count" }, "summary": { "zh": "本模块帮助一起核对 TRADJENTA／トラゼンタ、利格列汀、5 mg、口服片剂和目标市场；不提供个人剂量、开始、停用、转换或联用方案。", "en": "This module helps check TRADJENTA / トラゼンタ, linagliptin, 5 mg, oral-tablet form and target market together; it does not provide an individual's dose, initiation, stopping, switching or co-use plan." }, "checks": [ { "zh": "把商品名、利格列汀、5 mg、口服片剂和目标市场作为一组核对。5 mg 是这一准确片剂的标示强度信息，不是每个人应服几片或能否把另一种降糖药换算成同一产品的答案。", "en": "Check brand, linagliptin, 5 mg, oral-tablet form and target market as one set. 5 mg is stated strength information for this exact tablet, not an answer to how many tablets anyone should take or whether another glucose-lowering medicine converts to the same product." }, { "zh": "标签提示与胰岛素或促胰岛素分泌药联用时需要专业核对。手上同时有多种口服降糖药、胰岛素、注射笔、保健品或近期处方变化时，应把全部实际包装和完整用药清单交给药师或开方团队。", "en": "The label flags professional review when insulin or an insulin secretagogue is also used. With several oral glucose medicines, insulin, injection pens, supplements or recent prescription changes, have a pharmacist or prescribing team review every actual pack and the complete medicine list." }, { "zh": "相同的降糖用途、相近类别或包装上都写 mg，并不表示药物可以自行叠加、轮换、替换或按数字换算。", "en": "A shared glucose-lowering purpose, related class or milligram wording on a pack does not mean products can be self-combined, alternated, substituted or numerically converted." } ], "source": { "id": "src_ce041faec8321ea2", "label": "DailyMed (NLM): TRADJENTA linagliptin U.S. public label", "url": "https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=c797ea5c-cab7-494b-9044-27eba0cfe40f&type=display", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "利格列汀怎样起作用：它抑制 DPP-4，影响肠促胰岛素激素的失活过程", "en": "How linagliptin works: it inhibits DPP-4, affecting incretin-hormone inactivation" }, "summary": { "zh": "DailyMed 标签将利格列汀描述为选择性 DPP-4 抑制剂，并说明 DPP-4 会使 GLP-1 和 GIP 等肠促胰岛素激素失活。该机制解释一条药理路径，不预测个人血糖反应，也不决定片数、联用、转换或停用。", "en": "The DailyMed label describes linagliptin as a selective DPP-4 inhibitor and explains that DPP-4 inactivates incretin hormones including GLP-1 and GIP. This explains one pharmacologic pathway; it does not predict an individual's glucose response or determine tablet count, co-use, switching or stopping." }, "checks": [ { "zh": "“DPP-4”“GLP-1”或“肠促胰岛素”是机制词，不表示可以把 TRADJENTA 与另一种 DPP-4 抑制剂、GLP-1 类药物、胰岛素或其他降糖药自行叠加、轮换或替代。", "en": "“DPP-4,” “GLP-1” and “incretin” are mechanism terms; they do not permit self-combining, alternating or substituting TRADJENTA with another DPP-4 inhibitor, a GLP-1 medicine, insulin or another glucose-lowering medicine." }, { "zh": "机制不能把一次血糖值、感觉好坏或包装上的 mg 变成个人加减、补用、停药或换药规则。", "en": "Mechanism cannot turn one glucose result, a feeling or milligram text on a pack into an individual rule for increasing, making up, stopping or switching." }, { "zh": "机制页只解释标签所述的生物学路径；出现低血糖、脱水、严重或持续不适、用药清单不清或近期换方等实际情形，应带齐所有包装向药师、医生或当地紧急服务寻求针对个人的帮助。", "en": "This mechanism section explains only the pathway described in the label. For hypoglycaemia, dehydration, severe or persistent symptoms, an unclear medicine list or a recent prescription change, take every pack to a pharmacist, clinician or local emergency service for individual help." } ], "source": { "id": "src_ce041faec8321ea2", "label": "DailyMed (NLM): TRADJENTA linagliptin U.S. public label (Clinical Pharmacology)", "url": "https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=c797ea5c-cab7-494b-9044-27eba0cfe40f&type=display", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "Tradjenta", "generic": "利格列汀", "dosageFormClass": "口服薄膜衣片：5 mg（公开标签产品身份信息）" }, "labelSource": { "id": "src_ce041faec8321ea2", "label": "DailyMed (NLM): TRADJENTA linagliptin U.S. public label", "url": "https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=c797ea5c-cab7-494b-9044-27eba0cfe40f&type=display", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "productRoutes": [ { "source": { "id": "src_ce041faec8321ea2", "label": "DailyMed (NLM): TRADJENTA linagliptin U.S. public label", "url": "https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=c797ea5c-cab7-494b-9044-27eba0cfe40f&type=display", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_0e545d144f268b88", "label": "FDA: TRADJENTA U.S. label archive (Dec 2016; NDA 201280)", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/201280s015lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_6b0b4b744953ccf8", "label": "PMDA: TRADJENTA 5 mg current product record (Japan)", "url": "https://www.pmda.go.jp/PmdaSearch/rdDetail/iyaku/3969014F1024_1?user=1", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "status": "product_level_public_record_verified", "authority": { "zh": "PMDA", "en": "PMDA" }, "market": { "zh": "日本", "en": "Japan" }, "recordType": { "zh": "监管产品记录", "en": "Regulatory product record" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "美国 DailyMed 的 TRADJENTA（linagliptin）公开标签与日本 PMDA 的トラゼンタ錠 5 mg 产品页，可用于核对商品名、利格列汀、5 mg 口服片剂和目标市场。它不把包装数字转换为个人片数，也不按“同属降糖药”判断能否自行叠加、轮换、停用或替代。", "history": "FDA 公开标签列示 TRADJENTA 的美国初始批准年份为 2011。日本 PMDA 当前记录列示トラゼンタ錠 5 mg及利格列汀成分；两份市场文件均只能作为相应产品身份的来源核对入口。", "sourceDocuments": [ { "id": "src_ce041faec8321ea2", "label": "DailyMed (NLM): TRADJENTA linagliptin U.S. public label", "url": "https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=c797ea5c-cab7-494b-9044-27eba0cfe40f&type=display", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_0e545d144f268b88", "label": "FDA: TRADJENTA U.S. label archive (Dec 2016; NDA 201280)", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/201280s015lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_6b0b4b744953ccf8", "label": "PMDA: TRADJENTA 5 mg current product record (Japan)", "url": "https://www.pmda.go.jp/PmdaSearch/rdDetail/iyaku/3969014F1024_1?user=1", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } ], "applicationNumber": "NDA 201280", "approvalTimeline": [ { "date": "2011", "title": { "zh": "FDA 标签所列美国初始批准年份", "en": "Initial U.S. approval year listed in the FDA label" }, "detail": { "zh": "本页链接的 FDA 标签档案列示 Initial U.S. Approval: 2011。该历史定位不等同于当前批准、可得性、持有人或其他市场状态。", "en": "The FDA label archive linked here lists Initial U.S. Approval: 2011. This historical locator is not a conclusion about current approval, availability, holder or another market." }, "source": { "id": "src_0e545d144f268b88", "label": "FDA: TRADJENTA label archive", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/201280s015lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, { "date": "2016-12", "title": { "zh": "FDA 标签档案版本", "en": "FDA label archive version" }, "detail": { "zh": "本页链接 2016-12 的 FDA 标签档案作为可复核阅读入口。现行标签、规格、适应症和安全信息必须另行以目标市场当前文件核对。", "en": "This page links the 2016-12 FDA label archive as a traceable reading entry point. Current labeling, strength, indication and safety information require separate verification against the target market’s current document." }, "source": { "id": "src_0e545d144f268b88", "label": "FDA: TRADJENTA label archive", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/201280s015lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "已链接公开标签档案", "en": "Public label archive linked" }, "detail": { "zh": "仅对应本页所列 FDA 文件。", "en": "Only the FDA document listed on this page is linked." } }, { "market": { "zh": "中国大陆、欧盟、日本", "en": "Mainland China, EU, Japan" }, "status": { "zh": "待逐项建立市场记录", "en": "Market record not established" }, "detail": { "zh": "不从美国标签档案推定当地批准、持有人、规格、供应或可售资格。", "en": "No local approval, holder, strength, supply or sale-eligibility conclusion is inferred from the U.S. label archive." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "标签档案能代表现在的产品信息吗？", "en": "Does a label archive represent current product information?" }, "answer": { "zh": "不能自动代表。档案用于定位来源；需要以目标市场的现行官方标签逐项复核。", "en": "Not automatically. The archive locates a source; each point needs verification against the target market’s current official label." } }, { "question": { "zh": "为什么这里不展示价格或原研/仿制结论？", "en": "Why are price and originator/generic conclusions not shown?" }, "answer": { "zh": "这些结论需要产品、剂型、规格、包装、市场、日期和原始记录分别齐全并经人工审核；单一标签文件不足以支持。", "en": "Those conclusions require separately complete and human-reviewed product, dosage-form, strength, pack, market, date and primary-record fields; one label file is insufficient." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "how-to-read-a-drug-label", "regulatory-sources-first" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/tradjenta/", "en": "https://origindrug.com/en/drugs/tradjenta/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "jardiance", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-21", "status": "published_traceable_archive" }, "names": { "brand": "Jardiance", "generic": "恩格列净", "aliases": [ "empagliflozin" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "代谢", "sourceArchiveMarket": "美国当前公开处方药标签（2026-01-30 生效）与 FDA 历史监管档案", "dosageFormClass": "恩格列净口服薄膜衣片：10 mg、25 mg；各精确展示 30 片泡罩板纸盒（3 板 × 10 片）", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "2014（FDA 标签所列美国初始批准）", "archiveSponsorText": "Boehringer Ingelheim / FDA 与 DailyMed 公开监管标签档案" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [ "SYNJARDY", "GLYXAMBI", "JARDIANCE DUO", "empagliflozin metformin", "empagliflozin linagliptin" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-jardiance-empagliflozin-tablet-10mg-0597015237", "marketCode": "US", "labelVersion": { "zh": "2026-01-30 生效；DailyMed 当前公开标签", "en": "effective 30 Jan 2026; current DailyMed public label" }, "dosageForm": { "zh": "恩格列净口服薄膜衣片", "en": "empagliflozin oral film-coated tablet" }, "route": { "zh": "口服（仅作标签产品身份字段）", "en": "oral (label product-identity field only)" }, "routeCodes": [ "oral" ], "productCode": "NDC 0597-0152-37", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片 10 mg；30 片纸盒（3 板 × 10 片）", "en": "10 mg per tablet; 30-tablet carton (3 blister cards × 10 tablets)" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=faf3dd6a-9cd0-39c2-0d2e-232cb3f67565&name=jardiance-09.jpg", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "恩格列净", "en": "empagliflozin" }, "value": 10, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人服用片数、加减、补服、换药或换算指令", "en": "labelled amount per tablet; not an individual tablet count, adjustment, make-up, switching or conversion instruction" } } ], "concentration": null, "container": { "typeCode": "blister_card_carton", "typeLabel": { "zh": "泡罩板纸盒", "en": "blister-card carton" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "片/盒", "en": "tablets per carton" }, "unitsPerContainer": { "count": 10, "unit": { "zh": "片/泡罩板", "en": "tablets per blister card" } } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-21", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 30, "unit": { "zh": "片/盒（3 板 × 10 片）", "en": "tablets per carton (3 blister cards × 10 tablets)" } }, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_59049fb4f1401ed0", "label": "DailyMed（NLM）：JARDIANCE 恩格列净 10 mg、30 片泡罩板纸盒当前美国公开标签面板（Boehringer Ingelheim，2026-01）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=faf3dd6a-9cd0-39c2-0d2e-232cb3f67565", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-jardiance-empagliflozin-tablet-25mg-0597015337", "marketCode": "US", "labelVersion": { "zh": "2026-01-30 生效；DailyMed 当前公开标签", "en": "effective 30 Jan 2026; current DailyMed public label" }, "dosageForm": { "zh": "恩格列净口服薄膜衣片", "en": "empagliflozin oral film-coated tablet" }, "route": { "zh": "口服（仅作标签产品身份字段）", "en": "oral (label product-identity field only)" }, "routeCodes": [ "oral" ], "productCode": "NDC 0597-0153-37", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片 25 mg；30 片纸盒（3 板 × 10 片）", "en": "25 mg per tablet; 30-tablet carton (3 blister cards × 10 tablets)" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=faf3dd6a-9cd0-39c2-0d2e-232cb3f67565&name=jardiance-10.jpg", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "恩格列净", "en": "empagliflozin" }, "value": 25, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人服用片数、加减、补服、换药或换算指令", "en": "labelled amount per tablet; not an individual tablet count, adjustment, make-up, switching or conversion instruction" } } ], "concentration": null, "container": { "typeCode": "blister_card_carton", "typeLabel": { "zh": "泡罩板纸盒", "en": "blister-card carton" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "片/盒", "en": "tablets per carton" }, "unitsPerContainer": { "count": 10, "unit": { "zh": "片/泡罩板", "en": "tablets per blister card" } } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-21", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 30, "unit": { "zh": "片/盒（3 板 × 10 片）", "en": "tablets per carton (3 blister cards × 10 tablets)" } }, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_59049fb4f1401ed0", "label": "DailyMed（NLM）：JARDIANCE 恩格列净 25 mg、30 片泡罩板纸盒当前美国公开标签面板（Boehringer Ingelheim，2026-01）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=faf3dd6a-9cd0-39c2-0d2e-232cb3f67565", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-jardiance-empagliflozin-tablet-25mg-0597015337", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=jardiance-10.jpg&setid=faf3dd6a-9cd0-39c2-0d2e-232cb3f67565&type=img", "alt": "JARDIANCE 25 mg 在美国 DailyMed 公开标签中的包装标签图", "archiveMarket": "美国", "labelVersion": "2026-01-30 生效；DailyMed 当前公开标签", "presentation": "JARDIANCE（恩格列净）25 mg、30 片泡罩板纸盒（3 板 × 10 片；NDC 0597-0153-37；DailyMed 当前美国公开标签）。", "notice": "此图只对应美国 DailyMed 当前公开标签中的 JARDIANCE、恩格列净 25 mg、NDC 0597-0153-37、30 片泡罩板纸盒（3 板 × 10 片）；只帮助核对来源与产品身份，不用于鉴定真伪，也不证明 10 mg、其他 NDC、复方产品、其他市场标签、原研身份、当前可得性、目标市场批准或可替代性。", "source": { "id": "src_59049fb4f1401ed0", "label": "DailyMed（NLM）：JARDIANCE 恩格列净当前美国公开标签（Boehringer Ingelheim，2026-01）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=faf3dd6a-9cd0-39c2-0d2e-232cb3f67565", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "JARDIANCE 说明书放大阅读：25 mg 先是包装所示的产品强度", "en": "JARDIANCE label reading: 25 mg first identifies the packaged product strength" }, "summary": { "zh": "本模块以美国 DailyMed 2026-01 当前标签为公开阅读入口，帮助读者核对 JARDIANCE、10 mg 或 25 mg、每片强度与 30 片泡罩板纸盒；它不把包装强度或包装数量转成个人用药方案。", "en": "This module uses the current Jan 2026 U.S. DailyMed label as a public reading entry point, helping readers check JARDIANCE, 10 mg or 25 mg, strength per tablet and the 30-tablet blister-card carton; it does not turn strength or package count into an individual treatment plan." }, "checks": [ { "zh": "先把商品名 JARDIANCE、通用名恩格列净（empagliflozin）、“25 mg”、口服片剂和目标市场一起核对。包装上的 25 mg 是该图所示产品强度，不是任何人每天应服几片的答案。", "en": "Check JARDIANCE, the generic name empagliflozin, “25 mg”, oral-tablet form and target market together. The 25 mg on this package is the illustrated product strength, not an answer to how many tablets any person should take." }, { "zh": "糖尿病、心力衰竭或慢性肾病等词语不能自行推导为“这盒药适合我”。是否适用、何时用、能否换规格或停用，都需要回到具体病情、处方和目标市场的现行标签。", "en": "Terms such as diabetes, heart failure or chronic kidney disease cannot be used to conclude that this pack is suitable for a particular person. Suitability, timing, a strength change or stopping all require the individual clinical context, prescription and current label in the target market." }, { "zh": "若同时使用利尿剂、胰岛素或其他降糖产品，或在生病、进食饮水异常、手术前后出现用药疑问，应带上完整药品清单请开方团队或药师核对；不要仅凭网页或包装自行加减、补服或替换。", "en": "If diuretics, insulin or other glucose-lowering products are also used, or questions arise around illness, unusual eating or drinking, or surgery, bring the complete medicine list to the prescribing team or pharmacist. Do not add, reduce, make up or replace doses from a webpage or package alone." }, { "zh": "外观图和文字仅是核对起点。包装不同、市场不同、标签更新或由其他主体分装时，都可能改变外观和标示；照片不能证明真伪或当前获批状态。", "en": "The image and text are only a checking starting point. Packaging can differ by market, label update or repackaging; a photograph cannot establish authenticity or current approval status." } ], "source": { "id": "src_59049fb4f1401ed0", "label": "DailyMed（NLM）：JARDIANCE 恩格列净当前美国公开标签（Boehringer Ingelheim，2026-01）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=faf3dd6a-9cd0-39c2-0d2e-232cb3f67565", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "恩格列净怎样起作用：它影响肾脏对葡萄糖的重吸收", "en": "How empagliflozin works: it affects renal glucose reabsorption" }, "summary": { "zh": "FDA 公开标签描述：SGLT2 是使肾小球滤过液中的葡萄糖重新回到循环中的主要转运体；恩格列净抑制 SGLT2，从而减少重吸收、降低肾糖阈并增加尿糖排出。这是机制阅读，不是个人能否使用、与其他降糖药怎样组合或如何处理不适的方案。", "en": "The FDA public label describes SGLT2 as the predominant transporter that returns glucose from glomerular filtrate to the circulation. Empagliflozin inhibits SGLT2, reducing reabsorption, lowering the renal glucose threshold and increasing urinary glucose excretion. This is mechanism reading, not a plan for individual use, combination with other glucose-lowering medicines or management of symptoms." }, "checks": [ { "zh": "“让更多葡萄糖经尿液排出”不等于每个人都可凭此判断适合使用，也不能由此自行增加、减少或补服片数。具体疾病、肾功能、饮水进食状况与现行处方必须一起核对。", "en": "“More glucose leaves in urine” does not mean every person can decide from this that the medicine is suitable, or self-increase, decrease or make up tablets. The clinical situation, kidney function, eating and drinking status, and current prescription must be reviewed together." }, { "zh": "共同机制不使 JARDIANCE 与其他 SGLT2 抑制剂、胰岛素、利尿剂或其他降糖药可自行替换或叠加。共同名称、相近数字或他人的方案都不足以决定个人组合。", "en": "A shared mechanism does not make JARDIANCE self-substitutable or self-combinable with other SGLT2 inhibitors, insulin, diuretics or other glucose-lowering medicines. A shared name, a similar number or another person's regimen cannot decide an individual's combination." }, { "zh": "生病、进食饮水异常、手术前后、血糖异常或出现不适时，机制说明不能决定下一步。应带上实际包装和完整药单请开方团队或药师核对。", "en": "During illness, unusual eating or drinking, around surgery, with abnormal glucose readings or symptoms, a mechanism explanation cannot decide the next step. Take the actual pack and complete medicine list to the prescribing team or pharmacist for review." } ], "source": { "id": "src_c367c16b04b8fab7", "label": "FDA：JARDIANCE 2016-07 美国标签档案（临床药理）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204629s012lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "Jardiance", "generic": "恩格列净", "dosageFormClass": "恩格列净口服薄膜衣片：10 mg、25 mg；各精确展示 30 片泡罩板纸盒（3 板 × 10 片）" }, "labelSource": { "id": "src_59049fb4f1401ed0", "label": "DailyMed（NLM）：JARDIANCE 恩格列净当前美国公开标签（Boehringer Ingelheim，2026-01）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=faf3dd6a-9cd0-39c2-0d2e-232cb3f67565", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "productRoutes": [ { "source": { "id": "src_59049fb4f1401ed0", "label": "DailyMed（NLM）：JARDIANCE 恩格列净当前美国公开标签（Boehringer Ingelheim，2026-01）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=faf3dd6a-9cd0-39c2-0d2e-232cb3f67565", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_c367c16b04b8fab7", "label": "FDA：JARDIANCE 2016-07 美国标签档案（NDA 204629）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204629s012lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [ { "id": "fda-faers-sglt2-2023-dka-label-update-listing", "issuedAt": "2023-09-30", "status": "fda_potential_signal_label_update_listing", "title": { "zh": "FDA FAERS 记录：SGLT2 抑制剂相关标签更新线索", "en": "FDA FAERS record: SGLT2-inhibitor labelling-update information" }, "summary": { "zh": "FDA 的 2023 年 7–9 月潜在严重风险/新安全信息表（页面标示数据截至 2026-03-13）列出 Jardiance（恩格列净）和 Farxiga（达格列净）等 SGLT2 抑制剂，并说明该类产品的“警告和注意事项”已于 2023 年 9 月更新，纳入持续时间延长的糖尿病酮症酸中毒与尿糖信息。该表是监管安全信号与标签更新记录，不可用于判断个人是否发生相关问题；个人情况仍需结合实际产品、症状、检验和专业评估处理。", "en": "FDA’s July–September 2023 potential-signal/new-safety-information table, displayed as current through 2026-03-13, lists Jardiance (empagliflozin) and Farxiga (dapagliflozin) among SGLT2 inhibitors and says their Warnings and Precautions labelling was updated in September 2023 to include prolonged diabetic ketoacidosis and glucosuria information. This is a regulatory safety-signal and labelling-update record; it cannot determine an individual event or support self-stopping, switching or changing treatment." }, "source": { "id": "src_8c74002392ff8c7f", "label": "FDA：FAERS 2023 年 7–9 月潜在严重风险/新安全信息表（SGLT2 抑制剂标签更新）", "url": "https://www.fda.gov/drugs/fda-adverse-event-monitoring-system-aems/july-september-2023-potential-signals-serious-risksnew-safety-information-identified-fda-adverse", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "DailyMed 的当前 JARDIANCE（empagliflozin）美国公开标签展示 10 mg 与 25 mg 口服薄膜衣片，各为 30 片泡罩板纸盒（3 板 × 10 片）。本页把品牌、通用名、每片标示强度、包装与来源一起核对；不将包装数字变成个人片数、加减、补服、停用、替代或联用方案。", "history": "FDA 的历史资料记录 JARDIANCE 的美国初始批准年份为 2014；当前包装身份以 2026-01-30 生效的 DailyMed 公开标签为准。历史资料与当前标签都不能推定其他市场的注册、持有人、供应、可售资格或原研/仿制关系。", "sourceDocuments": [ { "id": "src_c367c16b04b8fab7", "label": "FDA：JARDIANCE 2016-07 美国标签档案（NDA 204629）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204629s012lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_59049fb4f1401ed0", "label": "DailyMed（NLM）：JARDIANCE 恩格列净当前美国公开标签（Boehringer Ingelheim，2026-01）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=faf3dd6a-9cd0-39c2-0d2e-232cb3f67565", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_5ed30b676fbb9773", "label": "FDA Drugs@FDA 官方检索入口", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_lookup_entry", "documentKind": "regulatory_lookup", "market": "US", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } ], "applicationNumber": "NDA 204629", "approvalTimeline": [ { "date": "2014", "title": { "zh": "FDA 标签所列美国初始批准年份", "en": "Initial U.S. approval year listed in the FDA label" }, "detail": { "zh": "本页链接的 FDA 标签档案列示 Initial U.S. Approval: 2014。该历史定位不等同于当前批准、可得性、持有人或其他市场状态。", "en": "The FDA label archive linked here lists Initial U.S. Approval: 2014. This historical locator is not a conclusion about current approval, availability, holder or another market." }, "source": { "id": "src_c367c16b04b8fab7", "label": "FDA: JARDIANCE label archive", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204629s012lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, { "date": "2016-07", "title": { "zh": "FDA 标签档案版本", "en": "FDA label archive version" }, "detail": { "zh": "本页链接 2016-07 的 FDA 标签档案作为可复核阅读入口。现行标签、规格、适应症和安全信息必须另行以目标市场当前文件核对。", "en": "This page links the 2016-07 FDA label archive as a traceable reading entry point. Current labeling, strength, indication and safety information require separate verification against the target market’s current document." }, "source": { "id": "src_c367c16b04b8fab7", "label": "FDA: JARDIANCE label archive", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204629s012lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "已链接公开标签档案", "en": "Public label archive linked" }, "detail": { "zh": "仅对应本页所列 FDA 文件。", "en": "Only the FDA document listed on this page is linked." } }, { "market": { "zh": "中国大陆、欧盟、日本", "en": "Mainland China, EU, Japan" }, "status": { "zh": "待逐项建立市场记录", "en": "Market record not established" }, "detail": { "zh": "不从美国标签档案推定当地批准、持有人、规格、供应或可售资格。", "en": "No local approval, holder, strength, supply or sale-eligibility conclusion is inferred from the U.S. label archive." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "标签档案能代表现在的产品信息吗？", "en": "Does a label archive represent current product information?" }, "answer": { "zh": "不能自动代表。档案用于定位来源；需要以目标市场的现行官方标签逐项复核。", "en": "Not automatically. The archive locates a source; each point needs verification against the target market’s current official label." } }, { "question": { "zh": "为什么这里不展示价格或原研/仿制结论？", "en": "Why are price and originator/generic conclusions not shown?" }, "answer": { "zh": "这些结论需要产品、剂型、规格、包装、市场、日期和原始记录分别齐全并经人工审核；单一标签文件不足以支持。", "en": "Those conclusions require separately complete and human-reviewed product, dosage-form, strength, pack, market, date and primary-record fields; one label file is insufficient." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "how-to-read-a-drug-label", "regulatory-sources-first" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/jardiance/", "en": "https://origindrug.com/en/drugs/jardiance/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "farxiga", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-23", "status": "published_traceable_archive" }, "names": { "brand": "Farxiga", "generic": "达格列净", "aliases": [ "安达唐", "フォシーガ", "dapagliflozin" ], "marketBrandNames": [ { "name": "フォシーガ", "market": { "zh": "日本", "en": "Japan" }, "evidenceStatus": "current_regulatory_record", "note": { "zh": "PMDA 当前产品页列フォシーガ片 5 mg／10 mg、达格列净成分及阿斯利康株式会社；仅作为日文名称、片剂与市场记录的核对入口，不确认其他包装、供应、可售资格或可自行换药。", "en": "The current PMDA product page lists FORXIGA (フォシーガ) 5 mg and 10 mg tablets, dapagliflozin and AstraZeneca K.K.; it is only a check point for the Japanese name, tablet form and market record, not another pack, supply, availability or self-directed switching." }, "source": { "id": "src_57c86a992bcc667d", "label": "PMDA：フォシーガ錠 5 mg／10 mg 当前产品页", "url": "https://www.pmda.go.jp/PmdaSearch/rdDetail/iyaku/3969019F1027_2", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, { "name": "安达唐", "market": { "zh": "中国大陆", "en": "Mainland China" }, "evidenceStatus": "first_party_brand_history", "note": { "zh": "阿斯利康中国 2017 年新闻稿将安达唐®标为达格列净片；这是可追溯的历史品牌/通用名线索，不替代中国大陆当前批准、标签、供应或可售资格核验。", "en": "A 2017 AstraZeneca China release identifies 安达唐® as dapagliflozin tablets. This is a traceable historical brand/generic-name cue, not a current Mainland China approval, label, supply or availability finding." }, "source": { "id": "src_1ef2111ce3b78170", "label": "阿斯利康中国：安达唐®／达格列净片历史上市新闻稿（2017）", "url": "https://www.astrazeneca.com.cn/zh/media/press-releases/2017/_sglt2_0.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "first_party_release", "market": "CN", "accessStatus": "public_access_with_site_controls", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } } ], "mainlandChinaTradeNameCue": { "value": "安达唐®", "status": "discovery_cue_requires_target_market_verification", "source": { "id": "src_120799f95f53075d", "label": "青岛市人民政府：2024 年医院药品记录中的安达唐／达格列净片 10 mg 记录", "url": "https://www.qingdao.gov.cn/ywdt/zwzl/ggqsydwgk/wsjk_208049/yy/qdsdbrmyy/zzbs/jg/202409/P020240913416639640028.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "government_medicine_listing", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-12", "reviewedAt": "2026-09-12" } } }, "identity": { "therapeuticArea": "代谢", "sourceArchiveMarket": "美国 FARXIGA 公开品牌标签（DailyMed 2026-06 更新）；日本 PMDA 当前フォシーガ片 5 mg／10 mg 产品记录；中国大陆安达唐®／达格列净片一手历史品牌资料（2017；不作为当前批准、供应或可售资格结论）", "dosageFormClass": "美国与日本公开来源均列达格列净口服片 5 mg、10 mg；本档案仅分别展示美国 30 片瓶装面板，其他市场包装须按当地文件核对", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "2014（FDA 标签所列美国初始批准）", "archiveSponsorText": "AstraZeneca Pharmaceuticals LP / DailyMed（NLM）公开标签；PMDA 日本产品记录；阿斯利康中国历史品牌资料" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [ "XIGDUO XR", "dapagliflozin metformin", "QTERN", "dapagliflozin saxagliptin", "QTERNMET XR", "dapagliflozin saxagliptin metformin" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-farxiga-dapagliflozin-tablet-5mg-0310620530", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前公开标签（2026-06 更新）", "en": "current DailyMed public label (updated Jun 2026)" }, "dosageForm": { "zh": "达格列净口服薄膜衣片", "en": "dapagliflozin oral film-coated tablet" }, "route": { "zh": "口服（仅作标签产品身份字段）", "en": "oral (label product-identity field only)" }, "routeCodes": [ "oral" ], "productCode": "NDC 0310-6205-30", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片 5 mg；30 片瓶装", "en": "5 mg per tablet; 30-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=72ad22ae-efe6-4cd6-a302-98aaee423d69&name=farxiga_5mg_30ct.jpg", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "达格列净", "en": "dapagliflozin" }, "value": 5, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人服用片数、加减、补服、换药或换算指令", "en": "labelled amount per tablet; not an individual tablet count, adjustment, make-up, switching or conversion instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "塑料瓶", "en": "plastic bottle" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-21", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 30, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "黄色", "en": "yellow" }, "shape": { "zh": "圆形", "en": "round" }, "imprint": "5 / 1427", "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_5a208081956d67a5", "label": "DailyMed（NLM）：FARXIGA 达格列净 5 mg、30 片瓶装美国公开标签面板（AstraZeneca，2026-06 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=72ad22ae-efe6-4cd6-a302-98aaee423d69", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-farxiga-dapagliflozin-tablet-10mg-0310621030", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前公开标签（2026-06 更新）", "en": "current DailyMed public label (updated Jun 2026)" }, "dosageForm": { "zh": "达格列净口服薄膜衣片", "en": "dapagliflozin oral film-coated tablet" }, "route": { "zh": "口服（仅作标签产品身份字段）", "en": "oral (label product-identity field only)" }, "routeCodes": [ "oral" ], "productCode": "NDC 0310-6210-30", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片 10 mg；30 片瓶装", "en": "10 mg per tablet; 30-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=72ad22ae-efe6-4cd6-a302-98aaee423d69&name=farxiga_10mg_30ct.jpg", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "达格列净", "en": "dapagliflozin" }, "value": 10, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人服用片数、加减、补服、换药或换算指令", "en": "labelled amount per tablet; not an individual tablet count, adjustment, make-up, switching or conversion instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "塑料瓶", "en": "plastic bottle" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-21", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 30, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "黄色", "en": "yellow" }, "shape": { "zh": "菱形", "en": "diamond-shaped" }, "imprint": "10 / 1428", "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_5a208081956d67a5", "label": "DailyMed（NLM）：FARXIGA 达格列净 10 mg、30 片瓶装美国公开标签面板（AstraZeneca，2026-06 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=72ad22ae-efe6-4cd6-a302-98aaee423d69", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-farxiga-dapagliflozin-tablet-5mg-0310620530", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=farxiga_5mg_30ct.jpg&setid=72ad22ae-efe6-4cd6-a302-98aaee423d69&type=img", "alt": "FARXIGA 5 mg 达格列净口服片剂在美国 DailyMed 公开标签中的瓶装主展示图", "archiveMarket": "美国", "labelVersion": "DailyMed 当前公开标签（2026-06 更新）", "presentation": "FARXIGA（达格列净）5 mg、30 片瓶装主展示面（NDC 0310-6205-30；DailyMed 2026-06 公开标签）。", "notice": "此图只对应美国 DailyMed 公开标签中的 FARXIGA、达格列净 5 mg、NDC 0310-6205-30、30 片瓶装；只帮助核对来源与产品身份，不用于鉴定真伪，也不证明 10 mg、其他 NDC、含达格列净的复方产品、其他市场标签、原研身份、当前可得性、目标市场批准或可替代性。", "source": { "id": "src_5a208081956d67a5", "label": "DailyMed（NLM）：FARXIGA 达格列净 5 mg、30 片瓶装美国公开标签面板（AstraZeneca，2026-06 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=72ad22ae-efe6-4cd6-a302-98aaee423d69", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "FARXIGA 说明书放大阅读：5 mg 与 10 mg 先是不同产品强度", "en": "FARXIGA label reading: 5 mg and 10 mg first identify different product strengths" }, "summary": { "zh": "本模块以 DailyMed 公开标签为阅读入口，帮助将 FARXIGA、达格列净、口服片剂和每片强度分开核对；它不把包装数字转成个人每天该服几片的结论。", "en": "This module uses the public DailyMed label as a reading entry point. It helps distinguish FARXIGA, dapagliflozin, oral-tablet form and strength per tablet; it does not turn package numbers into a conclusion about how many tablets anyone should take each day." }, "checks": [ { "zh": "先同时核对商品名、通用名、口服片剂、每片强度和目标市场：美国标签使用 FARXIGA，日本 PMDA 使用フォシーガ，中国历史一手资料使用安达唐®。5 mg/10 mg 表示每片所标示的产品强度；不同名称、市场或同为达格列净，均不代表任何人可以自行加倍、减半、替代或换药。", "en": "Check the brand, generic name, oral-tablet form, strength per tablet and target market together: the U.S. label uses FARXIGA, PMDA uses フォシーガ in Japan, and historical AstraZeneca China material uses 安达唐®. 5 mg/10 mg identifies the stated strength per tablet; different names, markets or the same dapagliflozin ingredient do not permit independent doubling, halving, substitution or switching." }, { "zh": "糖尿病、心力衰竭或慢性肾病等标签词不能从药盒反推出个人适用性。尤其在肾功能、进食饮水、急性疾病或围手术期变化时，应由具体处方和当地专业人员判断，而不是依据旧标签或网络摘要自行调整。", "en": "Label terms such as diabetes, heart failure or chronic kidney disease cannot be used to infer individual suitability from a package. Changes in kidney function, eating or drinking, acute illness or the perioperative period require the exact prescription and local professional assessment, not self-adjustment from an old label or web summary." }, { "zh": "若同时使用利尿剂、胰岛素或其他降糖产品，任何新增、停用、补服或换用都应带完整药单向药师/开方团队核对。相互作用或低血糖提示不是个人的“能用/不能用”清单。", "en": "If diuretics, insulin or other glucose-lowering products are also used, bring the complete medicine list to a pharmacist or prescribing team before any addition, stop, make-up dose or switch. Interaction or hypoglycaemia wording is not a personal “can/cannot use” list." }, { "zh": "不同市场、标签更新和再包装都会改变包装外观或文字；页面上的名称与强度只能帮助定位来源，不能验证手中产品真伪或当前获批状态。", "en": "Different markets, label updates and repackaging can change package appearance or wording. The name and strength on this page only help locate a source; they cannot authenticate a product in hand or establish current approval status." } ], "source": { "id": "src_81a270a4d25cd890", "label": "DailyMed（NLM）：FARXIGA 公开标签（2026-07 修订；再包装标签，仅作版本阅读入口）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=01f90c94-71cb-4a1f-81ff-8004b850529b", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "达格列净怎样起作用：它在肾脏近端小管降低葡萄糖重吸收", "en": "How dapagliflozin works: it reduces glucose reabsorption in the kidney's proximal tubule" }, "summary": { "zh": "FDA 的 FARXIGA 公开标签将达格列净描述为 SGLT2 抑制剂：它降低肾脏近端小管对过滤后葡萄糖的重吸收，从而促进葡萄糖经尿液排出。它说明的是作用路径；并不能据此判断某个人该用哪种降糖药、是否适合联用、该喝多少水或该怎样调整用药。", "en": "The FDA public FARXIGA label describes dapagliflozin as an SGLT2 inhibitor: it lowers reabsorption of filtered glucose in the kidney's proximal tubule, promoting urinary glucose excretion. This describes an action pathway; it cannot determine which glucose-lowering medicine a person should use, whether products can be combined, how much fluid to drink or how use should be adjusted." }, "checks": [ { "zh": "可把“重吸收”理解为肾脏把过滤后的某些物质收回体内的一道步骤。这里的机制有助于理解为什么标签会提到尿糖和体液相关问题，但不能用尿量、一次血糖值、口渴或脚肿来推导自行加量、减量、补服或停药。", "en": "“Reabsorption” can be read as a kidney step that takes some filtered substances back into the body. This mechanism helps explain why the label discusses urinary glucose and fluid-related issues, but urine output, one glucose result, thirst or ankle swelling cannot be used to self-direct an increase, decrease, make-up dose or stop." }, { "zh": "同一 FDA 标签也描述了钠重吸收和远端小管钠递送的变化。它提示把利尿剂、降压药、其他降糖药和全部实际包装带去一起核对的重要性；不能由此得出某两种药可自行叠加、轮换或互相替代。", "en": "The same FDA label also describes changes involving sodium reabsorption and distal-tubule sodium delivery. That highlights why diuretics, blood-pressure medicines, other glucose-lowering medicines and all actual packages should be reviewed together; it does not establish that any two products can be self-combined, alternated or substituted." }, { "zh": "5 mg、10 mg、片剂外观和商品名属于产品身份信息，与“药物怎样起作用”是不同层面。即使通用名相同或机制相近，也必须由目标市场现行标签和专业人员核对具体剂型、规格、肾功能、急性疾病情况及完整用药清单。", "en": "5 mg, 10 mg, tablet appearance and brand name are product-identity information, a different layer from how a medicine works. Even with the same generic name or a related mechanism, the current target-market label and a professional must review the exact form, strength, kidney function, acute-illness context and complete medicine list." } ], "source": { "id": "src_33753de2058f22ce", "label": "FDA：FARXIGA 2024-06 处方信息（临床药理）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/202293s031lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "Farxiga", "generic": "达格列净", "dosageFormClass": "美国与日本公开来源均列达格列净口服片 5 mg、10 mg；本档案仅分别展示美国 30 片瓶装面板，其他市场包装须按当地文件核对" }, "labelSource": { "id": "src_81a270a4d25cd890", "label": "DailyMed（NLM）：FARXIGA 公开标签（2026-07 修订；再包装标签，仅作版本阅读入口）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=01f90c94-71cb-4a1f-81ff-8004b850529b", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "productRoutes": [ { "source": { "id": "src_81a270a4d25cd890", "label": "DailyMed（NLM）：FARXIGA 公开标签（2026-07 修订；再包装标签，仅作版本阅读入口）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=01f90c94-71cb-4a1f-81ff-8004b850529b", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_770aed6324375a3f", "label": "FDA：FARXIGA 2023-05 美国标签档案（NDA 202293）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/202293s026lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_33753de2058f22ce", "label": "FDA：FARXIGA 2024-06 处方信息（临床药理）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/202293s031lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_5a208081956d67a5", "label": "DailyMed（NLM）：FARXIGA 达格列净美国公开品牌标签及 5 mg/10 mg 包装面板（AstraZeneca，2026-06 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=72ad22ae-efe6-4cd6-a302-98aaee423d69", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_57c86a992bcc667d", "label": "PMDA：フォシーガ錠 5 mg／10 mg 当前产品页", "url": "https://www.pmda.go.jp/PmdaSearch/rdDetail/iyaku/3969019F1027_2", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "status": "product_level_public_record_verified", "authority": { "zh": "PMDA", "en": "PMDA" }, "market": { "zh": "日本", "en": "Japan" }, "recordType": { "zh": "监管产品记录", "en": "Regulatory product record" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [ { "id": "fda-faers-sglt2-2023-dka-label-update-listing", "issuedAt": "2023-09-30", "status": "fda_potential_signal_label_update_listing", "title": { "zh": "FDA FAERS 记录：SGLT2 抑制剂相关标签更新线索", "en": "FDA FAERS record: SGLT2-inhibitor labelling-update information" }, "summary": { "zh": "FDA 的 2023 年 7–9 月潜在严重风险/新安全信息表（页面标示数据截至 2026-03-13）列出 Jardiance（恩格列净）和 Farxiga（达格列净）等 SGLT2 抑制剂，并说明该类产品的“警告和注意事项”已于 2023 年 9 月更新，纳入持续时间延长的糖尿病酮症酸中毒与尿糖信息。该表是监管安全信号与标签更新记录，不可用于判断个人是否发生相关问题；个人情况仍需结合实际产品、症状、检验和专业评估处理。", "en": "FDA’s July–September 2023 potential-signal/new-safety-information table, displayed as current through 2026-03-13, lists Jardiance (empagliflozin) and Farxiga (dapagliflozin) among SGLT2 inhibitors and says their Warnings and Precautions labelling was updated in September 2023 to include prolonged diabetic ketoacidosis and glucosuria information. This is a regulatory safety-signal and labelling-update record; it cannot determine an individual event or support self-stopping, switching or changing treatment." }, "source": { "id": "src_8c74002392ff8c7f", "label": "FDA：FAERS 2023 年 7–9 月潜在严重风险/新安全信息表（SGLT2 抑制剂标签更新）", "url": "https://www.fda.gov/drugs/fda-adverse-event-monitoring-system-aems/july-september-2023-potential-signals-serious-risksnew-safety-information-identified-fda-adverse", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "FARXIGA、フォシーガ和安达唐®是达格列净在不同市场出现的名称线索。美国 DailyMed 标签展示 FARXIGA 5 mg 与 10 mg 口服薄膜衣片及各自 30 片瓶装 NDC；日本 PMDA 当前产品页列フォシーガ片 5 mg／10 mg；阿斯利康中国 2017 年资料将安达唐®对应达格列净片。页面把品牌、通用名、每片标示强度、市场、实际包装和来源分开核对；不将名称关系或包装数字变成个人片数、加减、补服、停用、替代或联用方案。", "history": "FDA 历史资料记录 FARXIGA 的美国初始批准年份为 2014；本页的两张包装面板只对应 DailyMed 2026-06 公开标签中所列的 5 mg/10 mg、30 片瓶装。PMDA 当前产品页把日本フォシーガ片 5 mg／10 mg与达格列净成分相连；阿斯利康中国 2017 年公开资料将安达唐®列为达格列净片名称。它们是跨市场检索线索，不表示不同市场的标签、包装、适应症、供应或产品可自行互换。XIGDUO XR、QTERN 与 QTERNMET XR 含有达格列净但属于不同复方产品，不能按名称或成分重叠并入本单方片剂档案。", "sourceDocuments": [ { "id": "src_770aed6324375a3f", "label": "FDA：FARXIGA 2023-05 美国标签档案（NDA 202293）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/202293s026lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_33753de2058f22ce", "label": "FDA：FARXIGA 2024-06 处方信息（临床药理）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/202293s031lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_5a208081956d67a5", "label": "DailyMed（NLM）：FARXIGA 达格列净美国公开品牌标签及 5 mg/10 mg 包装面板（AstraZeneca，2026-06 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=72ad22ae-efe6-4cd6-a302-98aaee423d69", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_81a270a4d25cd890", "label": "DailyMed（NLM）：FARXIGA 公开标签（2026-07 修订；再包装标签，仅作版本阅读入口）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=01f90c94-71cb-4a1f-81ff-8004b850529b", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_57c86a992bcc667d", "label": "PMDA：フォシーガ錠 5 mg／10 mg 当前产品页", "url": "https://www.pmda.go.jp/PmdaSearch/rdDetail/iyaku/3969019F1027_2", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_1ef2111ce3b78170", "label": "阿斯利康中国：安达唐®／达格列净片历史上市新闻稿（2017）", "url": "https://www.astrazeneca.com.cn/zh/media/press-releases/2017/_sglt2_0.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "first_party_release", "market": "CN", "accessStatus": "public_access_with_site_controls", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_5ed30b676fbb9773", "label": "FDA Drugs@FDA 官方检索入口", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_lookup_entry", "documentKind": "regulatory_lookup", "market": "US", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } ], "applicationNumber": "NDA 202293", "approvalTimeline": [ { "date": "2014", "title": { "zh": "FDA 标签所列美国初始批准年份", "en": "Initial U.S. approval year listed in the FDA label" }, "detail": { "zh": "本页链接的 FDA 标签档案列示 Initial U.S. Approval: 2014。该历史定位不等同于当前批准、可得性、持有人或其他市场状态。", "en": "The FDA label archive linked here lists Initial U.S. Approval: 2014. This historical locator is not a conclusion about current approval, availability, holder or another market." }, "source": { "id": "src_770aed6324375a3f", "label": "FDA: FARXIGA label archive", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/202293s026lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, { "date": "2023-05", "title": { "zh": "FDA 标签档案版本", "en": "FDA label archive version" }, "detail": { "zh": "本页链接 2023-05 的 FDA 标签档案作为可复核阅读入口。现行标签、规格、适应症和安全信息必须另行以目标市场当前文件核对。", "en": "This page links the 2023-05 FDA label archive as a traceable reading entry point. Current labeling, strength, indication and safety information require separate verification against the target market’s current document." }, "source": { "id": "src_770aed6324375a3f", "label": "FDA: FARXIGA label archive", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/202293s026lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "已链接公开标签档案", "en": "Public label archive linked" }, "detail": { "zh": "仅对应本页所列 FDA 文件。", "en": "Only the FDA document listed on this page is linked." } }, { "market": { "zh": "中国大陆、欧盟、日本", "en": "Mainland China, EU, Japan" }, "status": { "zh": "待逐项建立市场记录", "en": "Market record not established" }, "detail": { "zh": "不从美国标签档案推定当地批准、持有人、规格、供应或可售资格。", "en": "No local approval, holder, strength, supply or sale-eligibility conclusion is inferred from the U.S. label archive." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "标签档案能代表现在的产品信息吗？", "en": "Does a label archive represent current product information?" }, "answer": { "zh": "不能自动代表。档案用于定位来源；需要以目标市场的现行官方标签逐项复核。", "en": "Not automatically. The archive locates a source; each point needs verification against the target market’s current official label." } }, { "question": { "zh": "为什么这里不展示价格或原研/仿制结论？", "en": "Why are price and originator/generic conclusions not shown?" }, "answer": { "zh": "这些结论需要产品、剂型、规格、包装、市场、日期和原始记录分别齐全并经人工审核；单一标签文件不足以支持。", "en": "Those conclusions require separately complete and human-reviewed product, dosage-form, strength, pack, market, date and primary-record fields; one label file is insufficient." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "how-to-read-a-drug-label", "regulatory-sources-first" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/farxiga/", "en": "https://origindrug.com/en/drugs/farxiga/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "invokana", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-28", "status": "published_traceable_archive" }, "names": { "brand": "Invokana", "generic": "卡格列净", "aliases": [ "canagliflozin", "卡格列净" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "代谢", "sourceArchiveMarket": "美国：链接 INVOKANA（卡格列净）当前公开品牌标签；分别建立 100 mg、300 mg 的 30 片瓶装文字身份和 90 片瓶装官方展示面。不建立中国大陆、欧盟、日本或其他市场的批准、供应、可售资格或产品关系结论。", "dosageFormClass": "INVOKANA 卡格列净口服薄膜衣片：100 mg、300 mg；30 片瓶装保留当前标签文字身份，90 片瓶装保留一一对应的当前官方展示面；500 片瓶装及其他包装另见原始标签", "dosageFormClassCode": "oral_solid", "route": "口服（美国当前标签产品身份字段）", "routeCode": "oral", "historicalApprovalEntry": "2013（美国标签所列初始批准）", "archiveSponsorText": "Janssen Pharmaceuticals, Inc. / FDA 与 DailyMed 公开监管标签档案" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [ "INVOKAMET", "INVOKAMET XR", "canagliflozin metformin" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-invokana-canagliflozin-tablet-100mg-30bottle-ndc-50458-140-30", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（2026-06 修订）", "en": "Current U.S. DailyMed public label (revised Jun 2026)" }, "dosageForm": { "zh": "INVOKANA 卡格列净口服薄膜衣片", "en": "INVOKANA canagliflozin film-coated oral tablet" }, "route": { "zh": "口服（标签产品身份字段）", "en": "oral (label product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 50458-140-30", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片卡格列净 100 mg；30 片瓶装", "en": "Canagliflozin 100 mg per tablet; 30-tablet bottle" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "卡格列净", "en": "canagliflozin" }, "value": 100, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、频率、补服或换算", "en": "labelled amount per tablet; not an individual's tablet count, frequency, missed-use instruction or conversion" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-26", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 30, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "黄色", "en": "yellow" }, "shape": { "zh": "胶囊形薄膜衣片", "en": "capsule-shaped film-coated tablet" }, "imprint": "CFZ / 100", "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_ed7eb50a648b450e", "label": "DailyMed（NLM）：INVOKANA 卡格列净当前美国公开标签（Janssen；2026-06 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b9057d3b-b104-4f09-8a61-c61ef9d4a3f3", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-invokana-canagliflozin-tablet-300mg-30bottle-ndc-50458-141-30", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（2026-06 修订）", "en": "Current U.S. DailyMed public label (revised Jun 2026)" }, "dosageForm": { "zh": "INVOKANA 卡格列净口服薄膜衣片", "en": "INVOKANA canagliflozin film-coated oral tablet" }, "route": { "zh": "口服（标签产品身份字段）", "en": "oral (label product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 50458-141-30", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片卡格列净 300 mg；30 片瓶装", "en": "Canagliflozin 300 mg per tablet; 30-tablet bottle" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "卡格列净", "en": "canagliflozin" }, "value": 300, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、频率、补服或换算", "en": "labelled amount per tablet; not an individual's tablet count, frequency, missed-use instruction or conversion" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-26", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 30, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "白色", "en": "white" }, "shape": { "zh": "胶囊形薄膜衣片", "en": "capsule-shaped film-coated tablet" }, "imprint": "CFZ / 300", "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_ed7eb50a648b450e", "label": "DailyMed（NLM）：INVOKANA 卡格列净当前美国公开标签（Janssen；2026-06 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b9057d3b-b104-4f09-8a61-c61ef9d4a3f3", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-invokana-canagliflozin-tablet-100mg-90bottle-ndc-50458-140-90", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（2026-06 修订；2026-08-28 复核）", "en": "Current U.S. DailyMed public label (revised Jun 2026; reviewed 28 Aug 2026)" }, "dosageForm": { "zh": "INVOKANA 卡格列净口服薄膜衣片", "en": "INVOKANA canagliflozin film-coated oral tablet" }, "route": { "zh": "口服（标签产品身份字段）", "en": "oral (label product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 50458-140-90", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片卡格列净 100 mg；90 片瓶装（NDC 50458-140-90）", "en": "Canagliflozin 100 mg per tablet; 90-tablet bottle (NDC 50458-140-90)" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=Invokana_Tablet_100+mg_90+Tabs_Bottle+label_10280906.jpg&setid=b9057d3b-b104-4f09-8a61-c61ef9d4a3f3&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "卡格列净", "en": "canagliflozin" }, "value": 100, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、频率、补服或换算", "en": "labelled amount per tablet; not an individual's tablet count, frequency, missed-use instruction or conversion" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 90, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-28", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "current_label_listed", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 90, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "黄色", "en": "yellow" }, "shape": { "zh": "胶囊形薄膜衣片", "en": "capsule-shaped film-coated tablet" }, "imprint": "CFZ / 100", "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_ed7eb50a648b450e", "label": "DailyMed（NLM）：INVOKANA 100 mg、NDC 50458-140-90、90 片瓶装当前美国公开展示面", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b9057d3b-b104-4f09-8a61-c61ef9d4a3f3", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-invokana-canagliflozin-tablet-300mg-90bottle-ndc-50458-141-90", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（2026-06 修订；2026-08-28 复核）", "en": "Current U.S. DailyMed public label (revised Jun 2026; reviewed 28 Aug 2026)" }, "dosageForm": { "zh": "INVOKANA 卡格列净口服薄膜衣片", "en": "INVOKANA canagliflozin film-coated oral tablet" }, "route": { "zh": "口服（标签产品身份字段）", "en": "oral (label product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 50458-141-90", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片卡格列净 300 mg；90 片瓶装（NDC 50458-141-90）", "en": "Canagliflozin 300 mg per tablet; 90-tablet bottle (NDC 50458-141-90)" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=Invokana_Tablets_300+mg_90+Tabs_Bottle+label_10281205.jpg&setid=b9057d3b-b104-4f09-8a61-c61ef9d4a3f3&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "卡格列净", "en": "canagliflozin" }, "value": 300, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、频率、补服或换算", "en": "labelled amount per tablet; not an individual's tablet count, frequency, missed-use instruction or conversion" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 90, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-28", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "current_label_listed", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 90, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "白色", "en": "white" }, "shape": { "zh": "胶囊形薄膜衣片", "en": "capsule-shaped film-coated tablet" }, "imprint": "CFZ / 300", "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_ed7eb50a648b450e", "label": "DailyMed（NLM）：INVOKANA 300 mg、NDC 50458-141-90、90 片瓶装当前美国公开展示面", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b9057d3b-b104-4f09-8a61-c61ef9d4a3f3", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-invokana-canagliflozin-tablet-100mg-90bottle-ndc-50458-140-90", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=Invokana_Tablet_100+mg_90+Tabs_Bottle+label_10280906.jpg&setid=b9057d3b-b104-4f09-8a61-c61ef9d4a3f3&type=img", "alt": "INVOKANA 卡格列净在美国 DailyMed 当前标签中的 100 mg、NDC 50458-140-90、90 片瓶装展示面", "archiveMarket": "美国", "labelVersion": "DailyMed 当前公开标签（2026-06 修订；2026-08-28 复核）", "presentation": "INVOKANA 卡格列净：每片 100 mg，NDC 50458-140-90，90 片瓶装展示面。", "notice": "此图只对应美国 DailyMed 当前标签中的 INVOKANA、卡格列净 100 mg、NDC 50458-140-90 与 90 片瓶装。它只帮助核对商品名、通用名、每片标示量、薄膜衣片、包装数量、黄色胶囊形片、CFZ／100 刻印和来源；不用于鉴定真伪，也不证明 300 mg、30 片或 500 片包装、复方 INVOKAMET／INVOKAMET XR、其他市场、实时库存、原研身份、可替代性，或任何个人的片数、频率、停药、联用或换药方案。", "source": { "id": "src_ed7eb50a648b450e", "label": "DailyMed（NLM）：INVOKANA 100 mg、NDC 50458-140-90、90 片瓶装当前美国公开展示面", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b9057d3b-b104-4f09-8a61-c61ef9d4a3f3", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "INVOKANA 说明书放大阅读：先把 100/300 mg 与 30/90 片包装逐项对应", "en": "INVOKANA label reading: match 100/300 mg and 30/90-count packs item by item" }, "summary": { "zh": "本模块以美国 DailyMed 当前标签为阅读入口，帮助核对 INVOKANA、卡格列净、口服片、每片 100 mg 或 300 mg、NDC，以及 30 片文字身份与 90 片官方展示面。数字是产品身份字段，不会被网页转写为个人应服几片、何时服、漏服怎么办或能否换药的结论。", "en": "This module uses the current U.S. DailyMed label to check INVOKANA, canagliflozin, oral tablets, 100 mg or 300 mg per tablet, NDC, 30-count text identities and exact 90-count display panels. These numbers are product-identity fields; the page does not turn them into an individual's tablet count, timing, missed-use action or switching conclusion." }, "checks": [ { "zh": "100 mg 和 300 mg 是两种不同片剂强度；黄色、白色、刻印与瓶装数量只帮助比对所引美国标签。它们不代表可自行把一片掰开、合并、翻倍、减半或按毫克数替代另一种卡格列净或降糖产品。", "en": "100 mg and 300 mg are different tablet strengths. Colour, imprint and bottle count only help compare the cited U.S. label. They do not mean a person can split, combine, double, halve or substitute another canagliflozin or glucose-lowering product by milligrams." }, { "zh": "“糖尿病”“心血管”“肾脏”等标签词不等于网页能判断个人是否适用。肾功能、体液状态、年龄、完整药单、既往病史与当前处方必须由专业人员一起核对。", "en": "Label terms such as diabetes, cardiovascular and kidney do not enable a webpage to decide personal suitability. Kidney function, volume status, age, the complete medicine list, history and the current prescription need professional review together." }, { "zh": "INVOKAMET、INVOKAMET XR 或其他含二甲双胍的复方产品不能因名称或共同成分被视为同一种药。任何与胰岛素、促胰岛素分泌剂、利尿剂或其他降糖药的实际并用问题，均应带完整药单向药师或开方团队核对。", "en": "INVOKAMET, INVOKAMET XR and another metformin-containing combination cannot be treated as the same medicine because of a name or shared ingredient. Any actual co-use question involving insulin, an insulin secretagogue, a diuretic or another glucose-lowering medicine requires review of the complete medicine list by a pharmacist or prescribing team." }, { "zh": "标签中的不良反应与警示是需要阅读和核对的安全信息，不是网页替任何人决定继续、暂停、换药或自我处理的规则。若有急性或严重不适，应及时使用当地医疗或紧急支持渠道。", "en": "Adverse-reaction and warning material in a label is safety information to read and review, not a webpage rule that decides continuation, pausing, switching or self-management for anyone. With an acute or serious concern, use timely local medical or emergency support." } ], "source": { "id": "src_ed7eb50a648b450e", "label": "DailyMed（NLM）：INVOKANA 卡格列净当前美国公开标签（Janssen；2026-06 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b9057d3b-b104-4f09-8a61-c61ef9d4a3f3", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "卡格列净怎样起作用：它减少肾脏对过滤葡萄糖的重吸收", "en": "How canagliflozin works: it reduces the kidney's reabsorption of filtered glucose" }, "summary": { "zh": "FDA/美国 DailyMed 标签将卡格列净描述为 SGLT2 抑制剂。SGLT2 位于肾脏近端小管，参与将过滤后的多数葡萄糖重新吸收；卡格列净抑制 SGLT2，会减少这一重吸收、降低肾糖阈并增加尿糖排出。它解释的是药理路径，而不是个人血糖、肾功能、适用性、喝水量、用药剂量、联用或换药方案。", "en": "The FDA/U.S. DailyMed label describes canagliflozin as an SGLT2 inhibitor. SGLT2 in the kidney's proximal tubules participates in reabsorbing most filtered glucose; canagliflozin inhibits SGLT2, reducing that reabsorption, lowering the renal glucose threshold and increasing urinary glucose excretion. This explains a pharmacological pathway, not an individual's glucose, kidney function, suitability, fluid intake, dose, combination or switching plan." }, "checks": [ { "zh": "“更多葡萄糖经尿液排出”不能从一次尿糖、血糖、口渴、尿量或体重变化推导任何人是否该自行加减、补服或停用。实际读数和症状需要结合准确产品、完整药单和专业评估。", "en": "“More glucose leaves in urine” cannot turn one urine-glucose result, glucose reading, thirst, urine-volume change or weight change into a decision to self-adjust, make up or stop medicine. Actual readings and symptoms need the exact product, complete medicine list and professional assessment." }, { "zh": "共同属于 SGLT2 类，不使 INVOKANA、JARDIANCE、FARXIGA 或其他产品可以自行叠加、轮换或替代；共同机制更提示需要核对完整药单，而不是提供个人组合答案。", "en": "Sharing the SGLT2 class does not make INVOKANA, JARDIANCE, FARXIGA or another product self-combinable, alternatable or substitutable; a shared mechanism instead signals the need to review the complete medicine list, not a personal combination answer." }, { "zh": "机制无法判断糖尿病、足部问题、感染、头晕、呕吐、腹痛、呼吸不适或围手术期情况的下一步。出现急性、严重或令人担心的不适时，应使用当地医疗支持，而不是仅凭机制页面改药。", "en": "Mechanism cannot decide next steps for diabetes, foot concerns, infection, dizziness, vomiting, abdominal pain, breathing trouble or a perioperative situation. With an acute, serious or concerning symptom, use local medical support rather than change medicine from a mechanism page." } ], "source": { "id": "src_ed7eb50a648b450e", "label": "DailyMed（NLM）：INVOKANA 卡格列净当前美国公开标签（临床药理；2026-06 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b9057d3b-b104-4f09-8a61-c61ef9d4a3f3", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "Invokana", "generic": "卡格列净", "dosageFormClass": "INVOKANA 卡格列净口服薄膜衣片：100 mg、300 mg；30 片瓶装保留当前标签文字身份，90 片瓶装保留一一对应的当前官方展示面；500 片瓶装及其他包装另见原始标签" }, "labelSource": { "id": "src_ed7eb50a648b450e", "label": "DailyMed（NLM）：INVOKANA 卡格列净当前美国公开标签（Janssen；2026-06 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b9057d3b-b104-4f09-8a61-c61ef9d4a3f3", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" }, "productRoutes": [ { "source": { "id": "src_ed7eb50a648b450e", "label": "DailyMed（NLM）：INVOKANA 卡格列净当前美国公开标签（Janssen；2026-06 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b9057d3b-b104-4f09-8a61-c61ef9d4a3f3", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-28", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_df9060d2dd7f5c0e", "label": "FDA：INVOKANA（卡格列净）美国处方信息（NDA 204042；2026-06 修订）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/204042s044lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" }, "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-08-28", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-28", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "美国 DailyMed 当前 INVOKANA 标签列示卡格列净口服薄膜衣片 100 mg 与 300 mg。本页分别保留两种 30 片瓶装文字身份，并增加可与 NDC 50458-140-90、50458-141-90 一一对应的两种 90 片瓶装官方展示面。黄色 100 mg、白色 300 mg、强度和包装数量只用于核对准确产品，不是任何人的片数、时间、加减、补服、换药或联用指令。", "history": "美国当前标签列示 INVOKANA 的初始批准年份为 2013，处方信息于 2026-06 修订。标签会更新，且同一来源同时列有 30 片、90 片、500 片瓶装等包装；本档案将 30 片文字身份与 90 片官方图片分开建立，绝不把 90 片瓶图挂到 30 片记录。含卡格列净/二甲双胍的 INVOKAMET 与 INVOKAMET XR 是不同复方产品，不能从共同成分或相近名称推定可自行互换。", "sourceDocuments": [ { "id": "src_df9060d2dd7f5c0e", "label": "FDA：INVOKANA（卡格列净）美国处方信息（NDA 204042；2026-06 修订）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/204042s044lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" }, { "id": "src_ed7eb50a648b450e", "label": "DailyMed（NLM）：INVOKANA 卡格列净当前美国公开标签（Janssen；2026-06 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b9057d3b-b104-4f09-8a61-c61ef9d4a3f3", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" }, { "id": "src_5ed30b676fbb9773", "label": "FDA Drugs@FDA 官方检索入口", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_lookup_entry", "documentKind": "regulatory_lookup", "market": "US", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } ], "applicationNumber": "NDA 204042", "approvalTimeline": [ { "date": "2013", "title": { "zh": "FDA 标签所列美国初始批准年份", "en": "Initial U.S. approval year listed in the FDA label" }, "detail": { "zh": "本页链接的 FDA 标签档案列示 Initial U.S. Approval: 2013。该历史定位不等同于当前批准、可得性、持有人或其他市场状态。", "en": "The FDA label archive linked here lists Initial U.S. Approval: 2013. This historical locator is not a conclusion about current approval, availability, holder or another market." }, "source": { "id": "src_df9060d2dd7f5c0e", "label": "FDA: INVOKANA prescribing information", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/204042s044lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" } }, { "date": "2026-06", "title": { "zh": "FDA 标签档案版本", "en": "FDA label archive version" }, "detail": { "zh": "本页链接 2026-06 的 FDA 标签档案作为可复核阅读入口。现行标签、规格、适应症和安全信息必须另行以目标市场当前文件核对。", "en": "This page links the 2026-06 FDA label archive as a traceable reading entry point. Current labeling, strength, indication and safety information require separate verification against the target market’s current document." }, "source": { "id": "src_df9060d2dd7f5c0e", "label": "FDA: INVOKANA prescribing information", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/204042s044lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "已链接公开标签档案", "en": "Public label archive linked" }, "detail": { "zh": "仅对应本页所列 FDA 文件。", "en": "Only the FDA document listed on this page is linked." } }, { "market": { "zh": "中国大陆、欧盟、日本", "en": "Mainland China, EU, Japan" }, "status": { "zh": "待逐项建立市场记录", "en": "Market record not established" }, "detail": { "zh": "不从美国标签档案推定当地批准、持有人、规格、供应或可售资格。", "en": "No local approval, holder, strength, supply or sale-eligibility conclusion is inferred from the U.S. label archive." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "标签档案能代表现在的产品信息吗？", "en": "Does a label archive represent current product information?" }, "answer": { "zh": "不能自动代表。档案用于定位来源；需要以目标市场的现行官方标签逐项复核。", "en": "Not automatically. The archive locates a source; each point needs verification against the target market’s current official label." } }, { "question": { "zh": "为什么这里不展示价格或原研/仿制结论？", "en": "Why are price and originator/generic conclusions not shown?" }, "answer": { "zh": "这些结论需要产品、剂型、规格、包装、市场、日期和原始记录分别齐全并经人工审核；单一标签文件不足以支持。", "en": "Those conclusions require separately complete and human-reviewed product, dosage-form, strength, pack, market, date and primary-record fields; one label file is insufficient." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "how-to-read-a-drug-label", "regulatory-sources-first" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/invokana/", "en": "https://origindrug.com/en/drugs/invokana/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "victoza", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-17", "status": "published_traceable_archive" }, "names": { "brand": "Victoza", "generic": "利拉鲁肽", "aliases": [ "liraglutide" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "代谢", "sourceArchiveMarket": "美国公开监管标签档案", "dosageFormClass": "皮下注射液（FDA 2010 标签档案及 DailyMed 2025-11 公开标签所列）", "dosageFormClassCode": "subcutaneous_injection", "route": "皮下注射", "routeCode": "subcutaneous", "historicalApprovalEntry": "2010（FDA 标签所列美国初始批准）", "archiveSponsorText": "FDA / DailyMed 公开监管标签档案" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-victoza-liraglutide-18mg-3ml-2-prefilled-pens-0169406012", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v31（2025-11-17 发布）", "en": "DailyMed SPL v31 (published 17 Nov 2025)" }, "dosageForm": { "zh": "VICTOZA 利拉鲁肽单人使用预充注射笔", "en": "VICTOZA liraglutide single-patient-use prefilled pen" }, "route": { "zh": "皮下注射（标签产品身份字段）", "en": "subcutaneous injection (label product-identity field)" }, "routeCodes": [ "subcutaneous_injection" ], "productCode": "NDC 0169-4060-12", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "total_in_prefilled_pen", "primaryDisplay": { "zh": "每支笔总含量 18 mg/3 mL（6 mg/mL）；可选择的标签档位为 0.6、1.2 或 1.8 mg；每盒 2 支笔", "en": "18 mg/3 mL total per pen (6 mg/mL); labelled selectable settings are 0.6, 1.2 or 1.8 mg; 2 pens per carton" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=carton-2pen.jpg&setid=5a9ef4ea-c76a-4d34-a604-27c5b505f5a4", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "利拉鲁肽（每支笔总含量）", "en": "liraglutide (total per pen)" }, "value": 18, "unit": "mg", "basisCode": "total_in_prefilled_pen", "basisLabel": { "zh": "每支预充笔内总量；不是一次个人注射量", "en": "total in each prefilled pen; not an individual's one-time injection amount" } }, { "ingredient": { "zh": "利拉鲁肽（浓度）", "en": "liraglutide (concentration)" }, "value": 6, "unit": "mg/mL", "basisCode": "concentration", "basisLabel": { "zh": "标签浓度；不是个人注射毫升数", "en": "labelled concentration; not an individual's injection volume" } } ], "concentration": null, "container": { "typeCode": "multi_dose_prefilled_pen", "typeLabel": { "zh": "单人使用多剂量预充注射笔；针头不随盒提供", "en": "single-patient-use multidose prefilled pen; needles not included" }, "fill": { "value": 3, "unit": "mL" }, "countPerPackage": null, "countUnit": null, "unitsPerContainer": { "count": 18, "unit": { "zh": "mg 总量/笔", "en": "mg total per pen" } } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-28", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 2, "unit": { "zh": "支预充笔/盒；针头不随盒提供", "en": "prefilled pens per carton; needles not included" } }, "physicalClues": { "color": null, "shape": { "zh": "带剂量选择器的单人使用预充注射笔与纸盒", "en": "single-patient-use prefilled pen with dose selector and carton" }, "imprint": null, "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_113ee44d9dd0f6c1", "label": "DailyMed（NLM）：VICTOZA 当前美国公开标签（Novo Nordisk；SPL v31）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=5a9ef4ea-c76a-4d34-a604-27c5b505f5a4", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-victoza-liraglutide-18mg-3ml-3-prefilled-pens-0169406013", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v31（2025-11-17 发布）", "en": "DailyMed SPL v31 (published 17 Nov 2025)" }, "dosageForm": { "zh": "VICTOZA 利拉鲁肽单人使用预充注射笔", "en": "VICTOZA liraglutide single-patient-use prefilled pen" }, "route": { "zh": "皮下注射（标签产品身份字段）", "en": "subcutaneous injection (label product-identity field)" }, "routeCodes": [ "subcutaneous_injection" ], "productCode": "NDC 0169-4060-13", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "total_in_prefilled_pen", "primaryDisplay": { "zh": "每支笔总含量 18 mg/3 mL（6 mg/mL）；可选择的标签档位为 0.6、1.2 或 1.8 mg；每盒 3 支笔", "en": "18 mg/3 mL total per pen (6 mg/mL); labelled selectable settings are 0.6, 1.2 or 1.8 mg; 3 pens per carton" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=carton-3pen.jpg&setid=5a9ef4ea-c76a-4d34-a604-27c5b505f5a4", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "利拉鲁肽（每支笔总含量）", "en": "liraglutide (total per pen)" }, "value": 18, "unit": "mg", "basisCode": "total_in_prefilled_pen", "basisLabel": { "zh": "每支预充笔内总量；不是一次个人注射量", "en": "total in each prefilled pen; not an individual's one-time injection amount" } }, { "ingredient": { "zh": "利拉鲁肽（浓度）", "en": "liraglutide (concentration)" }, "value": 6, "unit": "mg/mL", "basisCode": "concentration", "basisLabel": { "zh": "标签浓度；不是个人注射毫升数", "en": "labelled concentration; not an individual's injection volume" } } ], "concentration": null, "container": { "typeCode": "multi_dose_prefilled_pen", "typeLabel": { "zh": "单人使用多剂量预充注射笔；针头不随盒提供", "en": "single-patient-use multidose prefilled pen; needles not included" }, "fill": { "value": 3, "unit": "mL" }, "countPerPackage": null, "countUnit": null, "unitsPerContainer": { "count": 18, "unit": { "zh": "mg 总量/笔", "en": "mg total per pen" } } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-28", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 3, "unit": { "zh": "支预充笔/盒；针头不随盒提供", "en": "prefilled pens per carton; needles not included" } }, "physicalClues": { "color": null, "shape": { "zh": "带剂量选择器的单人使用预充注射笔与纸盒", "en": "single-patient-use prefilled pen with dose selector and carton" }, "imprint": null, "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_113ee44d9dd0f6c1", "label": "DailyMed（NLM）：VICTOZA 当前美国公开标签（Novo Nordisk；SPL v31）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=5a9ef4ea-c76a-4d34-a604-27c5b505f5a4", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": null, "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=carton-3pen.jpg&id=905929", "alt": "VICTOZA 18 mg/3 mL（6 mg/mL）、3 支预充笔、NDC 0169-4060-13 的美国 DailyMed 公开标签纸盒主展示面", "archiveMarket": "美国", "labelVersion": "2025-11", "presentation": "VICTOZA 18 mg/3 mL（6 mg/mL）、3 支预充笔、NDC 0169-4060-13 纸盒主展示面（DailyMed 2025-11 公开标签所列）。", "notice": "此图只对应美国 DailyMed 标签中的 VICTOZA、18 mg/3 mL（6 mg/mL）、3 支预充笔和 NDC 0169-4060-13；它只帮助核对品牌、通用名、浓度、给药途径、包装/装置线索和来源，不用于鉴定真伪，也不证明其他包装、原研身份、当前包装、目标市场批准或可售资格。", "source": { "id": "src_113ee44d9dd0f6c1", "label": "DailyMed（NLM）：VICTOZA 公开标签（2025-11）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=5a9ef4ea-c76a-4d34-a604-27c5b505f5a4", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "VICTOZA 说明书放大阅读：6 mg/mL 是浓度，不是一次的个人用量", "en": "VICTOZA label reading: 6 mg/mL is a concentration, not an individual one-time amount" }, "summary": { "zh": "本模块以 DailyMed 公开标签为阅读入口，帮助区分 VICTOZA 预充笔上 18 mg/3 mL、6 mg/mL 与给药设置文字的含义；它不指导个人注射、调量、漏用补用或与其他注射产品转换。", "en": "This module uses the public DailyMed label as a reading entry point. It helps distinguish the meanings of 18 mg/3 mL, 6 mg/mL and dose-setting wording on a VICTOZA prefilled pen; it does not guide individual injection, dose change, missed-dose management or a switch with another injectable product." }, "checks": [ { "zh": "“18 mg/3 mL”描述整支预充笔中的标示药物总量和液体体积；“6 mg/mL”描述浓度。二者都不是“今天该打多少”或“是否可以把另一种注射笔当成一样”的答案。", "en": "“18 mg/3 mL” describes the stated total medicine amount and liquid volume in the prefilled pen; “6 mg/mL” describes concentration. Neither answers how much someone should inject today or whether another injection pen can be treated as the same." }, { "zh": "标签所列 0.6 mg、1.2 mg、1.8 mg 是该准确装置可标示的剂量设置，不是读者可依据网页自行开始、加量、减量或与其他 GLP-1 类产品互换的规则。", "en": "The label’s 0.6 mg, 1.2 mg and 1.8 mg are dose settings stated for that exact device, not rules a reader may use to independently start, increase, reduce or interchange with another GLP-1 product from a webpage." }, { "zh": "预充笔为单一患者使用装置；外观、针头、注射部位、保存和是否可与其他注射剂同用均要回到准确产品的现行使用说明、处方和专业人员指导。", "en": "A prefilled pen is a single-patient-use device. Appearance, needles, injection site, storage and whether it can be used with another injectable product all require the current instructions, prescription and professional guidance for the exact product." }, { "zh": "如果同时使用胰岛素或其他降糖药、出现持续胃肠道不适或正在考虑更换注射产品，请带上全部药物和实际包装请药师/开方团队核对；不要根据照片或总毫克数自行转换。", "en": "If insulin or other glucose-lowering medicines are also used, persistent gastrointestinal symptoms occur, or an injectable-product change is being considered, bring every medicine and the actual package to a pharmacist or prescribing team; do not self-convert from a photo or total milligrams." } ], "source": { "id": "src_113ee44d9dd0f6c1", "label": "DailyMed（NLM）：VICTOZA 公开标签（2025-11）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=5a9ef4ea-c76a-4d34-a604-27c5b505f5a4", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "利拉鲁肽怎样起作用：它激活 GLP-1 受体", "en": "How liraglutide works: it activates the GLP-1 receptor" }, "summary": { "zh": "DailyMed 的 VICTOZA 公开标签将利拉鲁肽描述为 GLP-1 受体激动剂。标签将该机制与葡萄糖升高时的胰岛素释放、葡萄糖依赖性的胰高血糖素降低及胃排空延迟联系起来。它解释的是一条作用路径，不预测个人血糖、胃肠道反应、体重变化、适用性、注射设置或与其他降糖药的组合。", "en": "The DailyMed public label for VICTOZA describes liraglutide as a GLP-1 receptor agonist. It links this mechanism with insulin release when glucose is elevated, glucose-dependent lowering of glucagon and delayed gastric emptying. This explains an action pathway, not an individual's glucose, gastrointestinal response, weight change, suitability, injection setting or combination with another glucose-lowering medicine." }, "checks": [ { "zh": "“GLP-1”不表示 VICTOZA 能与 OZEMPIC、WEGOVY、TRULICITY、MOUNJARO、其他利拉鲁肽产品或任何降糖药自行叠加、轮换或按总毫克数换算。每种产品的品牌、成分、装置、用途、强度和完整药单都要由专业人员逐项核对。", "en": "“GLP-1” does not make VICTOZA self-combinable, alternatable or convertible by total milligrams with OZEMPIC, WEGOVY, TRULICITY, MOUNJARO, another liraglutide product or any glucose-lowering medicine. Every product's brand, ingredient, device, use, strength and complete medicine list need item-by-item professional review." }, { "zh": "胃排空与血糖调节的机制不能生成自行错开口服药、补打、加量或换笔的规则。正在使用胰岛素、其他降糖药、口服药或出现持续胃肠道不适时，应带完整药单和实际包装请药师或开方团队复核。", "en": "Gastric-emptying and glucose-regulation mechanisms cannot create rules for self-spacing oral medicines, making up an injection, increasing use or switching pens. When insulin, another glucose medicine or oral medicine is used, or persistent gastrointestinal symptoms occur, bring the complete medicine list and actual packs to a pharmacist or prescribing team for review." }, { "zh": "“6 mg/mL”“18 mg/3 mL”及装置上的设置都是产品身份信息，不会从机制中导出个人注射量或证明另一支笔可替代。出现严重或持续不适、明显低血糖相关症状、拿到不同装置或对产品有疑问时，应使用当地医疗支持，而不是依据网页自行调整。", "en": "“6 mg/mL,” “18 mg/3 mL” and settings on a device are product-identity information; the mechanism does not derive an individual injection amount or prove another pen can substitute. With severe or persistent discomfort, marked symptoms related to low glucose, a different device or uncertainty about a product, use local medical support rather than self-adjust from a webpage." } ], "source": { "id": "src_113ee44d9dd0f6c1", "label": "DailyMed（NLM）：VICTOZA 公开标签（2025-11；临床药理）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=5a9ef4ea-c76a-4d34-a604-27c5b505f5a4", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "Victoza", "generic": "利拉鲁肽", "dosageFormClass": "皮下注射液（FDA 2010 标签档案及 DailyMed 2025-11 公开标签所列）" }, "labelSource": { "id": "src_113ee44d9dd0f6c1", "label": "DailyMed（NLM）：VICTOZA 公开标签（2025-11）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=5a9ef4ea-c76a-4d34-a604-27c5b505f5a4", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "productRoutes": [ { "source": { "id": "src_113ee44d9dd0f6c1", "label": "DailyMed（NLM）：VICTOZA 公开标签（2025-11）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=5a9ef4ea-c76a-4d34-a604-27c5b505f5a4", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_1c0d98095d46de65", "label": "FDA：VICTOZA 2010 美国标签档案（NDA 022341）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022341s000lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "FDA 的 VICTOZA（liraglutide）美国标签档案将其列为皮下注射用制剂，并列出美国初始批准年份为 2010。该页只提供可复核的美国监管档案；不据此推定现行标签、其他市场的批准、规格、持有人、供应或可售资格。", "history": "注射制剂不能仅按通用名与口服或其他给药途径产品互相等同。任何市场的产品身份、现行标签与专业使用信息都须单独核验。", "sourceDocuments": [ { "id": "src_1c0d98095d46de65", "label": "FDA：VICTOZA 2010 美国标签档案（NDA 022341）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022341s000lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_113ee44d9dd0f6c1", "label": "DailyMed（NLM）：VICTOZA 公开标签（2025-11）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=5a9ef4ea-c76a-4d34-a604-27c5b505f5a4", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_5ed30b676fbb9773", "label": "FDA Drugs@FDA 官方检索入口", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_lookup_entry", "documentKind": "regulatory_lookup", "market": "US", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } ], "applicationNumber": "NDA 022341", "approvalTimeline": [ { "date": "2010", "title": { "zh": "FDA 标签所列美国初始批准年份", "en": "Initial U.S. approval year listed in the FDA label" }, "detail": { "zh": "本页链接的 FDA 标签档案列示 Initial U.S. Approval: 2010。该历史定位不等同于当前批准、可得性、持有人或其他市场状态。", "en": "The FDA label archive linked here lists Initial U.S. Approval: 2010. This historical locator is not a conclusion about current approval, availability, holder or another market." }, "source": { "id": "src_1c0d98095d46de65", "label": "FDA: VICTOZA label archive", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022341s000lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, { "date": "2010", "title": { "zh": "FDA 标签档案版本", "en": "FDA label archive version" }, "detail": { "zh": "本页链接 2010 的 FDA 标签档案作为可复核阅读入口。现行标签、规格、适应症和安全信息必须另行以目标市场当前文件核对。", "en": "This page links the 2010 FDA label archive as a traceable reading entry point. Current labeling, strength, indication and safety information require separate verification against the target market’s current document." }, "source": { "id": "src_1c0d98095d46de65", "label": "FDA: VICTOZA label archive", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022341s000lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "已链接公开标签档案", "en": "Public label archive linked" }, "detail": { "zh": "仅对应本页所列 FDA 文件。", "en": "Only the FDA document listed on this page is linked." } }, { "market": { "zh": "中国大陆、欧盟、日本", "en": "Mainland China, EU, Japan" }, "status": { "zh": "待逐项建立市场记录", "en": "Market record not established" }, "detail": { "zh": "不从美国标签档案推定当地批准、持有人、规格、供应或可售资格。", "en": "No local approval, holder, strength, supply or sale-eligibility conclusion is inferred from the U.S. label archive." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "标签档案能代表现在的产品信息吗？", "en": "Does a label archive represent current product information?" }, "answer": { "zh": "不能自动代表。档案用于定位来源；需要以目标市场的现行官方标签逐项复核。", "en": "Not automatically. The archive locates a source; each point needs verification against the target market’s current official label." } }, { "question": { "zh": "为什么这里不展示价格或原研/仿制结论？", "en": "Why are price and originator/generic conclusions not shown?" }, "answer": { "zh": "这些结论需要产品、剂型、规格、包装、市场、日期和原始记录分别齐全并经人工审核；单一标签文件不足以支持。", "en": "Those conclusions require separately complete and human-reviewed product, dosage-form, strength, pack, market, date and primary-record fields; one label file is insufficient." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "dosage-forms-are-part-of-medicine-identity", "medicine-label-for-everyday-questions", "how-to-read-a-drug-label" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/victoza/", "en": "https://origindrug.com/en/drugs/victoza/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "ozempic", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-22", "status": "published_traceable_archive" }, "names": { "brand": "Ozempic", "generic": "司美格鲁肽", "aliases": [ "semaglutide" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "代谢", "sourceArchiveMarket": "美国当前公开标签：DailyMed SPL v20（2026-06-10 发布；处方信息 2026-05 修订）", "dosageFormClass": "司美格鲁肽皮下注射液：已逐项核对三个美国多剂量预充笔展示面（2 mg/3 mL、4 mg/3 mL、8 mg/3 mL）", "dosageFormClassCode": "subcutaneous_injection", "route": "皮下", "routeCode": "subcutaneous", "historicalApprovalEntry": "2017（FDA 标签所列美国初始批准）", "archiveSponsorText": "Novo Nordisk / FDA 与 DailyMed 公开监管资料" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-ozempic-semaglutide-025-05mg-2mg-3ml-ndc-0169-4181-13", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v20（2026-06-10 发布；处方信息 2026-05 修订）", "en": "DailyMed SPL v20 published 10 Jun 2026; prescribing information revised May 2026" }, "dosageForm": { "zh": "OZEMPIC 多剂量预充式注射笔", "en": "OZEMPIC multi-dose prefilled pen" }, "route": { "zh": "皮下（标签途径；网页不决定个人注射量、频率或补用）", "en": "subcutaneous (label route; this page does not decide individual injection amount, frequency or missed-use action)" }, "routeCodes": [ "subcutaneous" ], "productCode": "NDC 0169-4181-13", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "total_in_prefilled_pen", "primaryDisplay": { "zh": "0.25 / 0.5 mg 标示给药档位；2 mg/3 mL（0.68 mg/mL）多剂量预充笔", "en": "0.25 / 0.5 mg labelled dose options; 2 mg/3 mL (0.68 mg/mL) multi-dose prefilled pen" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=adec4fd2-6858-4c99-91d4-531f5f2a2d79&name=image-69.jpg", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "司美格鲁肽", "en": "semaglutide" }, "value": 2, "unit": "mg", "basisCode": "total_in_prefilled_pen", "basisLabel": { "zh": "每支预充笔内的标签总量；不是个人注射量、一次该用多少或可自行换算的依据", "en": "labelled total amount in one prefilled pen; not an individual's injection amount, amount for one use, or a self-conversion basis" } }, { "ingredient": { "zh": "司美格鲁肽", "en": "semaglutide" }, "value": 0.25, "unit": "mg", "basisCode": "labelled_dose_option", "basisLabel": { "zh": "该笔标签列出的给药档位；不是个人起始、加量、频率、补用或转换方案", "en": "labelled dose option for this pen; not an individual's initiation, escalation, frequency, missed-use or switching plan" } }, { "ingredient": { "zh": "司美格鲁肽", "en": "semaglutide" }, "value": 0.5, "unit": "mg", "basisCode": "labelled_dose_option", "basisLabel": { "zh": "该笔标签列出的给药档位；不是个人起始、加量、频率、补用或转换方案", "en": "labelled dose option for this pen; not an individual's initiation, escalation, frequency, missed-use or switching plan" } } ], "concentration": { "basisCode": "mg_per_mL", "notation": null, "numerator": { "value": 0.68, "unit": "mg" }, "denominator": { "value": 1, "unit": "mL" }, "display": { "zh": "0.68 mg/mL（标签浓度；不是个人注射量）", "en": "0.68 mg/mL (labelled concentration; not an individual injection amount)" } }, "container": { "typeCode": "multi_dose_prefilled_pen", "typeLabel": { "zh": "多剂量预充式注射笔", "en": "multi-dose prefilled pen" }, "fill": { "value": 3, "unit": "mL" }, "countPerPackage": 1, "countUnit": { "zh": "支/纸盒", "en": "pen per carton" } }, "deliveryDevice": { "typeCode": "multi_dose_prefilled_pen", "name": { "zh": "多剂量预充式注射笔", "en": "multi-dose prefilled pen" } }, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-22", "currentLabelDisplayed": true, "ndcDirectoryListed": false, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 1, "unit": { "zh": "支预充笔/纸盒（6 枚随附针头）", "en": "prefilled pen per carton (6 supplied needles)" } }, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_d8b4dd1d5f033cc9", "label": "DailyMed（NLM）：OZEMPIC 司美格鲁肽当前美国公开标签（Novo Nordisk；SPL v20，2026-06-10 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=adec4fd2-6858-4c99-91d4-531f5f2a2d79", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-ozempic-semaglutide-1mg-4mg-3ml-ndc-0169-4130-13", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v20（2026-06-10 发布；处方信息 2026-05 修订）", "en": "DailyMed SPL v20 published 10 Jun 2026; prescribing information revised May 2026" }, "dosageForm": { "zh": "OZEMPIC 多剂量预充式注射笔", "en": "OZEMPIC multi-dose prefilled pen" }, "route": { "zh": "皮下（标签途径；网页不决定个人注射量、频率或补用）", "en": "subcutaneous (label route; this page does not decide individual injection amount, frequency or missed-use action)" }, "routeCodes": [ "subcutaneous" ], "productCode": "NDC 0169-4130-13", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "total_in_prefilled_pen", "primaryDisplay": { "zh": "1 mg 标示给药档位；4 mg/3 mL（1.34 mg/mL）多剂量预充笔", "en": "1 mg labelled dose option; 4 mg/3 mL (1.34 mg/mL) multi-dose prefilled pen" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=adec4fd2-6858-4c99-91d4-531f5f2a2d79&name=image-70.jpg", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "司美格鲁肽", "en": "semaglutide" }, "value": 4, "unit": "mg", "basisCode": "total_in_prefilled_pen", "basisLabel": { "zh": "每支预充笔内的标签总量；不是个人注射量、一次该用多少或可自行换算的依据", "en": "labelled total amount in one prefilled pen; not an individual's injection amount, amount for one use, or a self-conversion basis" } }, { "ingredient": { "zh": "司美格鲁肽", "en": "semaglutide" }, "value": 1, "unit": "mg", "basisCode": "labelled_dose_option", "basisLabel": { "zh": "该笔标签列出的给药档位；不是个人起始、加量、频率、补用或转换方案", "en": "labelled dose option for this pen; not an individual's initiation, escalation, frequency, missed-use or switching plan" } } ], "concentration": { "basisCode": "mg_per_mL", "notation": null, "numerator": { "value": 1.34, "unit": "mg" }, "denominator": { "value": 1, "unit": "mL" }, "display": { "zh": "1.34 mg/mL（标签浓度；不是个人注射量）", "en": "1.34 mg/mL (labelled concentration; not an individual injection amount)" } }, "container": { "typeCode": "multi_dose_prefilled_pen", "typeLabel": { "zh": "多剂量预充式注射笔", "en": "multi-dose prefilled pen" }, "fill": { "value": 3, "unit": "mL" }, "countPerPackage": 1, "countUnit": { "zh": "支/纸盒", "en": "pen per carton" } }, "deliveryDevice": { "typeCode": "multi_dose_prefilled_pen", "name": { "zh": "多剂量预充式注射笔", "en": "multi-dose prefilled pen" } }, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-22", "currentLabelDisplayed": true, "ndcDirectoryListed": false, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 1, "unit": { "zh": "支预充笔/纸盒（4 枚随附针头）", "en": "prefilled pen per carton (4 supplied needles)" } }, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_d8b4dd1d5f033cc9", "label": "DailyMed（NLM）：OZEMPIC 司美格鲁肽当前美国公开标签（Novo Nordisk；SPL v20，2026-06-10 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=adec4fd2-6858-4c99-91d4-531f5f2a2d79", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-ozempic-semaglutide-2mg-8mg-3ml-ndc-0169-4772-12", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v20（2026-06-10 发布；处方信息 2026-05 修订）", "en": "DailyMed SPL v20 published 10 Jun 2026; prescribing information revised May 2026" }, "dosageForm": { "zh": "OZEMPIC 多剂量预充式注射笔", "en": "OZEMPIC multi-dose prefilled pen" }, "route": { "zh": "皮下（标签途径；网页不决定个人注射量、频率或补用）", "en": "subcutaneous (label route; this page does not decide individual injection amount, frequency or missed-use action)" }, "routeCodes": [ "subcutaneous" ], "productCode": "NDC 0169-4772-12", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "total_in_prefilled_pen", "primaryDisplay": { "zh": "2 mg 标示给药档位；8 mg/3 mL（2.68 mg/mL）多剂量预充笔", "en": "2 mg labelled dose option; 8 mg/3 mL (2.68 mg/mL) multi-dose prefilled pen" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=adec4fd2-6858-4c99-91d4-531f5f2a2d79&name=image-72.jpg", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "司美格鲁肽", "en": "semaglutide" }, "value": 8, "unit": "mg", "basisCode": "total_in_prefilled_pen", "basisLabel": { "zh": "每支预充笔内的标签总量；不是个人注射量、一次该用多少或可自行换算的依据", "en": "labelled total amount in one prefilled pen; not an individual's injection amount, amount for one use, or a self-conversion basis" } }, { "ingredient": { "zh": "司美格鲁肽", "en": "semaglutide" }, "value": 2, "unit": "mg", "basisCode": "labelled_dose_option", "basisLabel": { "zh": "该笔标签列出的给药档位；不是个人起始、加量、频率、补用或转换方案", "en": "labelled dose option for this pen; not an individual's initiation, escalation, frequency, missed-use or switching plan" } } ], "concentration": { "basisCode": "mg_per_mL", "notation": null, "numerator": { "value": 2.68, "unit": "mg" }, "denominator": { "value": 1, "unit": "mL" }, "display": { "zh": "2.68 mg/mL（标签浓度；不是个人注射量）", "en": "2.68 mg/mL (labelled concentration; not an individual injection amount)" } }, "container": { "typeCode": "multi_dose_prefilled_pen", "typeLabel": { "zh": "多剂量预充式注射笔", "en": "multi-dose prefilled pen" }, "fill": { "value": 3, "unit": "mL" }, "countPerPackage": 1, "countUnit": { "zh": "支/纸盒", "en": "pen per carton" } }, "deliveryDevice": { "typeCode": "multi_dose_prefilled_pen", "name": { "zh": "多剂量预充式注射笔", "en": "multi-dose prefilled pen" } }, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-22", "currentLabelDisplayed": true, "ndcDirectoryListed": false, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 1, "unit": { "zh": "支预充笔/纸盒（4 枚随附针头）", "en": "prefilled pen per carton (4 supplied needles)" } }, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_d8b4dd1d5f033cc9", "label": "DailyMed（NLM）：OZEMPIC 司美格鲁肽当前美国公开标签（Novo Nordisk；SPL v20，2026-06-10 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=adec4fd2-6858-4c99-91d4-531f5f2a2d79", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-ozempic-semaglutide-025-05mg-2mg-3ml-ndc-0169-4181-13", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=adec4fd2-6858-4c99-91d4-531f5f2a2d79&name=image-69.jpg", "alt": "OZEMPIC 0.25 mg/0.5 mg 多剂量预充式注射笔在美国 DailyMed 公开标签中的 2 mg/3 mL、NDC 0169-4181-13 纸盒展示面", "archiveMarket": "美国", "labelVersion": "DailyMed SPL v20（2026-06-10 发布；处方信息 2026-05 修订）", "presentation": "OZEMPIC（司美格鲁肽）0.25 mg/0.5 mg 标示给药档位、2 mg/3 mL（0.68 mg/mL）多剂量预充笔，NDC 0169-4181-13；1 支预充笔与 6 枚随附针头/纸盒。", "notice": "此图只对应美国 DailyMed SPL v20 中 OZEMPIC、司美格鲁肽、NDC 0169-4181-13、2 mg/3 mL（0.68 mg/mL）的多剂量预充式注射笔展示面。它只帮助核对品牌、通用名、标示档位、总量、浓度、NDC、装置、包装与来源；不用于鉴定真伪，也不证明其他强度、其他 NDC、单剂量预充式注射器、其他市场、实际在售、库存、目标市场批准、原研身份、可替代性，或任何个人的注射量、频率、补用、加量、转换或联用方案。", "source": { "id": "src_d8b4dd1d5f033cc9", "label": "DailyMed（NLM）：OZEMPIC 司美格鲁肽当前美国公开标签（Novo Nordisk；SPL v20，2026-06-10 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=adec4fd2-6858-4c99-91d4-531f5f2a2d79", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "OZEMPIC 说明书放大阅读：注射笔上的 mg 与 mg/mL 要一起看", "en": "OZEMPIC label reading: read mg and mg/mL on a pen together" }, "summary": { "zh": "本模块以 FDA 2026 美国标签为阅读入口，帮助分开核对 OZEMPIC 注射笔的商品名、每次给药标示、浓度、装置和目标市场；它不提供个人起始、加量、漏用补救或与另一种司美格鲁肽产品转换的方案。", "en": "This module uses the 2026 U.S. FDA label as a reading entry point. It separates the OZEMPIC pen’s brand, stated dose, concentration, device and target market; it does not provide an individual starting, escalation, missed-dose or conversion plan to another semaglutide product." }, "checks": [ { "zh": "先把 OZEMPIC、司美格鲁肽、皮下注射、具体注射笔/包装和目标市场一起核对。仅看到相同通用名、相似笔形或一个相近的 mg 数字，不能证明两件产品可互换。", "en": "Check OZEMPIC, semaglutide, subcutaneous injection, the exact pen/package and target market together. A shared generic name, similar pen shape or nearby mg number does not prove two products can be exchanged." }, { "zh": "包装上的 mg 是标示的药物量，mg/mL 还包含液体体积与浓度信息；它们都不是“今天该打多少格、打几次或能否把两支合并”的答案。应以实际产品的现行标签、处方和专业人员指导核对。", "en": "A package’s mg states an amount of medicine, while mg/mL also includes liquid volume and concentration. Neither answers how many dial settings, injections or combined devices a person should use today. Check the current label, prescription and professional guidance for the actual product." }, { "zh": "正在使用胰岛素、促胰岛素分泌药或其他降糖/减重产品时，不能因都与血糖或体重有关就自行叠加、轮换或替换。把全部药单、装置和实际使用时间带给开方团队或药师复核。", "en": "When insulin, an insulin secretagogue, or another glucose- or weight-related product is used, do not self-combine, alternate or substitute simply because they relate to glucose or weight. Bring the complete medicine list, devices and actual timing to the prescribing team or pharmacist." }, { "zh": "持续呕吐、明显脱水、无法进食饮水、严重腹痛或对怎样使用装置不确定时，应及时使用当地医疗渠道；网页不应被当作调整注射频率或剂量的工具。", "en": "With persistent vomiting, marked dehydration, inability to eat or drink, severe abdominal pain, or uncertainty about device use, use timely local medical pathways; a webpage must not be used to adjust injection frequency or dose." } ], "source": { "id": "src_33c06ed649c74a32", "label": "FDA：OZEMPIC 2026 美国处方信息（NDA 209637）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/209637s038lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "司美格鲁肽怎样起作用：它激活 GLP-1 受体", "en": "How semaglutide works: it activates the GLP-1 receptor" }, "summary": { "zh": "FDA 标签将司美格鲁肽描述为 GLP-1 受体激动剂；这一通路与葡萄糖依赖性胰岛素分泌、胰高血糖素分泌和胃排空等标签所述作用有关。机制解释的是作用路径，不是任何个人的血糖变化、体重变化、剂量或适用性承诺。", "en": "The FDA label describes semaglutide as a GLP-1 receptor agonist. This pathway is linked in the label to glucose-dependent insulin secretion, glucagon secretion and gastric emptying. Mechanism explains an action pathway, not an individual's glucose change, weight change, dose or suitability." }, "checks": [ { "zh": "“GLP-1”不表示所有同类或同名产品可自行叠加、轮换或等量替代。注射装置、强度、给药途径、目标市场和全部药单仍需逐项核对。", "en": "“GLP-1” does not make all same-class or same-name products self-combinable, interchangeable or dose-equivalent. Injection device, strength, route, target market and the complete medicine list still need item-by-item review." }, { "zh": "标签对胃排空和血糖调节的描述，可提示口服合并用药和低血糖风险为何需要专业人员复核；它不能产生自行错开时间、补用或调整任何药物的规则。", "en": "The label’s discussion of gastric emptying and glucose regulation signals why oral co-medications and low-glucose risk need professional review; it cannot generate self-made spacing, make-up or adjustment rules." }, { "zh": "机制不是减重或控糖结果的保证。既往疾病、肾功能、饮食饮水、胃肠道症状和同时用药都需要回到现行标签、处方和专业评估。", "en": "Mechanism is not a guarantee of weight or glucose outcomes. Prior conditions, kidney function, food/fluid intake, gastrointestinal symptoms and co-medications all require the current label, prescription and professional assessment." } ], "source": { "id": "src_33c06ed649c74a32", "label": "FDA：OZEMPIC 2026 美国处方信息（临床药理）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/209637s038lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "Ozempic", "generic": "司美格鲁肽", "dosageFormClass": "司美格鲁肽皮下注射液：已逐项核对三个美国多剂量预充笔展示面（2 mg/3 mL、4 mg/3 mL、8 mg/3 mL）" }, "labelSource": { "id": "src_33c06ed649c74a32", "label": "FDA：OZEMPIC 美国处方信息（NDA 209637；2026-05 修订）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/209637s038lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "productRoutes": [ { "source": { "id": "src_33c06ed649c74a32", "label": "FDA：OZEMPIC 美国处方信息（NDA 209637；2026-05 修订）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/209637s038lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_d8b4dd1d5f033cc9", "label": "DailyMed（NLM）：OZEMPIC 司美格鲁肽当前美国公开标签（Novo Nordisk；SPL v20，2026-06-10 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=adec4fd2-6858-4c99-91d4-531f5f2a2d79", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [ { "id": "fda-2025-counterfeit-ozempic-us-supply-chain-alert", "issuedAt": "2025-12-05", "status": "fda_product_specific_counterfeit_alert", "title": { "zh": "FDA 药品警示：美国供应链中的特定假冒 Ozempic 1 mg 注射笔", "en": "FDA drug alert: specific counterfeit Ozempic 1 mg injection pens in the U.S. supply chain" }, "summary": { "zh": "FDA 于 2025-12-05 更新美国药品警示，说明其查获的假冒 Ozempic（semaglutide）1 mg 注射笔被非法分销至美国正规供应链中，公告列出标示批号 PAR1229 及笔身 EXP/LOT 字样位置这一特定核验线索，并要求美国患者不要使用符合该公告描述的产品。该记录只适用于美国、公告所述 1 mg 笔、批号/标签特征和公告日期；它不用于鉴定其他药盒真伪，不适用于其他规格、其他批次、其他市场或任何个人是否应使用 Ozempic 的结论。拍照文字识别、外观相似或网页搜索都不能替代药师、授权供应链和当地监管渠道对实际产品的核验。", "en": "In its U.S. alert updated on 2025-12-05, FDA said counterfeit Ozempic (semaglutide) 1 mg injection pens had been illegally distributed into the legitimate U.S. supply chain. The notice names lot PAR1229 and a specific EXP/LOT-text placement on the pen as checking cues, and tells U.S. patients not to use products that match its description. This record is limited to the U.S., the described 1 mg pen, lot/labelling features and notice date. It cannot authenticate another pack, apply to another strength, lot or market, or determine whether any individual should use Ozempic. Photo text recognition, visual similarity and an online search do not replace verification of the actual product through a pharmacist, authorised supply chain and local regulator routes." }, "source": { "id": "src_de13b9fd177e9431", "label": "FDA：美国供应链中特定假冒 Ozempic（semaglutide）1 mg 注射笔药品警示（2025-12-05 更新）", "url": "https://www.fda.gov/drugs/drug-alerts-and-statements/fda-warns-consumers-not-use-counterfeit-ozempic-semaglutide-found-us-drug-supply-chain", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "DailyMed 的 OZEMPIC（semaglutide）美国公开标签列示三个已逐项核对的多剂量预充式注射笔展示面：2 mg/3 mL、4 mg/3 mL、8 mg/3 mL。本页把商品名、通用名、标示给药档位、笔内总量、浓度、NDC、装置、包装与来源分开阅读；不将这些包装字段变成个人注射量、频率、补用、加量、转换、联用、购买或供应结论。", "history": "FDA 公开标签列示 OZEMPIC 的美国初始批准年份为 2017。此页三个包装展示面只对应 DailyMed SPL v20 中 NDC 0169-4181-13、0169-4130-13、0169-4772-12 的多剂量预充笔；同一标签内仍有 NDC 为 XXXX-XXXX-XX 的预充式注射器展示稿，不能被当作已确定的实际市售 NDC 或包装。标签会更新；任何实际使用、剂量、适应症、安全性或市场状态，均须以目标市场的现行文件和专业人员判断为准。", "sourceDocuments": [ { "id": "src_33c06ed649c74a32", "label": "FDA：OZEMPIC 美国处方信息（NDA 209637；2026-05 修订）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/209637s038lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_d8b4dd1d5f033cc9", "label": "DailyMed（NLM）：OZEMPIC 司美格鲁肽当前美国公开标签（Novo Nordisk；SPL v20，2026-06-10 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=adec4fd2-6858-4c99-91d4-531f5f2a2d79", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_5ed30b676fbb9773", "label": "FDA Drugs@FDA 官方检索入口", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_lookup_entry", "documentKind": "regulatory_lookup", "market": "US", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } ], "applicationNumber": "NDA 209637", "approvalTimeline": [ { "date": "2017", "title": { "zh": "FDA 标签所列美国初始批准年份", "en": "Initial U.S. approval year listed in the FDA label" }, "detail": { "zh": "本页链接的 FDA 标签档案列示 Initial U.S. Approval: 2017。该历史定位不等同于当前批准、可得性、持有人或其他市场状态。", "en": "The FDA label archive linked here lists Initial U.S. Approval: 2017. This historical locator is not a conclusion about current approval, availability, holder or another market." }, "source": { "id": "src_33c06ed649c74a32", "label": "FDA: OZEMPIC prescribing information", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/209637s038lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, { "date": "2026-05", "title": { "zh": "FDA 标签档案版本", "en": "FDA label archive version" }, "detail": { "zh": "本页链接 2026-05 的 FDA 标签档案作为可复核阅读入口。现行标签、规格、适应症和安全信息必须另行以目标市场当前文件核对。", "en": "This page links the 2026-05 FDA label archive as a traceable reading entry point. Current labeling, strength, indication and safety information require separate verification against the target market’s current document." }, "source": { "id": "src_33c06ed649c74a32", "label": "FDA: OZEMPIC prescribing information", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/209637s038lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "已链接公开标签档案", "en": "Public label archive linked" }, "detail": { "zh": "仅对应本页所列 FDA 文件。", "en": "Only the FDA document listed on this page is linked." } }, { "market": { "zh": "中国大陆、欧盟、日本", "en": "Mainland China, EU, Japan" }, "status": { "zh": "待逐项建立市场记录", "en": "Market record not established" }, "detail": { "zh": "不从美国标签档案推定当地批准、持有人、规格、供应或可售资格。", "en": "No local approval, holder, strength, supply or sale-eligibility conclusion is inferred from the U.S. label archive." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "标签档案能代表现在的产品信息吗？", "en": "Does a label archive represent current product information?" }, "answer": { "zh": "不能自动代表。档案用于定位来源；需要以目标市场的现行官方标签逐项复核。", "en": "Not automatically. The archive locates a source; each point needs verification against the target market’s current official label." } }, { "question": { "zh": "为什么这里不展示价格或原研/仿制结论？", "en": "Why are price and originator/generic conclusions not shown?" }, "answer": { "zh": "这些结论需要产品、剂型、规格、包装、市场、日期和原始记录分别齐全并经人工审核；单一标签文件不足以支持。", "en": "Those conclusions require separately complete and human-reviewed product, dosage-form, strength, pack, market, date and primary-record fields; one label file is insufficient." } } ], "relatedMedicineChecks": [ { "target": { "id": "rybelsus", "brand": "Rybelsus", "generic": "司美格鲁肽", "canonicalUrls": { "zh": "https://origindrug.com/drugs/rybelsus/", "en": "https://origindrug.com/en/drugs/rybelsus/" } }, "title": { "zh": "与 RYBELSUS／司美格鲁肽口服片 同在药单上时：同含司美格鲁肽先做完整药单核对", "en": "When RYBELSUS / oral semaglutide tablets is on the same list: products containing semaglutide need a complete medicine-list review" }, "summary": { "zh": "当前 DailyMed WEGOVY 美国公开标签的 Limitations of Use 提示：不建议将 WEGOVY 注射剂或片剂与其他含司美格鲁肽产品或其他 GLP-1 受体激动剂联用。这条来源限定的提示要求先把每个实际药盒、剂型、强度、处方、非处方药和补充剂交给药师或开方团队核对；它不判断个人能否同服，也不建议自行停用、错开时间、替换或调整任何一种药。", "en": "The current U.S. DailyMed WEGOVY public label states in Limitations of Use that concomitant use of WEGOVY injection or tablets with other semaglutide-containing products or any other GLP-1 receptor agonist is not recommended. This source-bounded cue means that every actual pack, dosage form, strength, prescription, OTC product and supplement should first be reviewed by a pharmacist or prescriber; it does not decide an individual's co-use or advise self-stopping, time-separation, replacement or adjustment of either medicine." }, "source": { "id": "src_aafb344bff238edf", "label": "DailyMed（NLM）：WEGOVY 当前美国公开标签（Limitations of Use：其他含司美格鲁肽产品／GLP-1 受体激动剂；SPL v19）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=ee06186f-2aa3-4990-a760-757579d8f77b", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "review_complete_medicine_list_no_self_directed_change" }, { "target": { "id": "wegovy", "brand": "Wegovy", "generic": "司美格鲁肽", "canonicalUrls": { "zh": "https://origindrug.com/drugs/wegovy/", "en": "https://origindrug.com/en/drugs/wegovy/" } }, "title": { "zh": "与 WEGOVY／司美格鲁肽产品 同在药单上时：同含司美格鲁肽先做完整药单核对", "en": "When WEGOVY / semaglutide product is on the same list: products containing semaglutide need a complete medicine-list review" }, "summary": { "zh": "当前 DailyMed WEGOVY 美国公开标签的 Limitations of Use 提示：不建议将 WEGOVY 注射剂或片剂与其他含司美格鲁肽产品或其他 GLP-1 受体激动剂联用。这条来源限定的提示要求先把每个实际药盒、剂型、强度、处方、非处方药和补充剂交给药师或开方团队核对；它不判断个人能否同服，也不建议自行停用、错开时间、替换或调整任何一种药。", "en": "The current U.S. DailyMed WEGOVY public label states in Limitations of Use that concomitant use of WEGOVY injection or tablets with other semaglutide-containing products or any other GLP-1 receptor agonist is not recommended. This source-bounded cue means that every actual pack, dosage form, strength, prescription, OTC product and supplement should first be reviewed by a pharmacist or prescriber; it does not decide an individual's co-use or advise self-stopping, time-separation, replacement or adjustment of either medicine." }, "source": { "id": "src_aafb344bff238edf", "label": "DailyMed（NLM）：WEGOVY 当前美国公开标签（Limitations of Use：其他含司美格鲁肽产品／GLP-1 受体激动剂；SPL v19）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=ee06186f-2aa3-4990-a760-757579d8f77b", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "review_complete_medicine_list_no_self_directed_change" } ], "relatedArticleSlugs": [ "dosage-forms-are-part-of-medicine-identity", "medicine-label-for-everyday-questions", "how-to-read-a-drug-label" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/ozempic/", "en": "https://origindrug.com/en/drugs/ozempic/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "rybelsus", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-23", "status": "published_traceable_archive" }, "names": { "brand": "Rybelsus", "generic": "司美格鲁肽", "aliases": [ "oral semaglutide", "semaglutide" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "代谢", "sourceArchiveMarket": "美国 DailyMed 当前公开标签（页面更新 2026-01-30；标签修订 2026-01）。本档案只建立标签明确列出的 RYBELSUS 3 mg、7 mg、14 mg 口服片及各自 30 片瓶装身份；不从该资料推定中国大陆、欧盟、日本或其他市场的商品名、批准、供应、可得性或可替代性。", "dosageFormClass": "口服司美格鲁肽片剂；不同配方、强度与包装必须分别核对（美国 2026 当前标签）", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "2019（FDA 原始批准资料：RYBELSUS NDA 213051）", "archiveSponsorText": "Novo Nordisk / FDA 与 DailyMed 公开监管资料" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-rybelsus-oral-semaglutide-tablet-3mg-30-bottle-ndc-0169430330", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（页面更新 2026-01-30；标签修订 2026-01）；仅为所引公开标签展示面，不代表供应", "en": "Current U.S. DailyMed public label (page updated 30 Jan 2026; label revised Jan 2026); cited public label panel only, not availability" }, "dosageForm": { "zh": "RYBELSUS 司美格鲁肽口服片", "en": "RYBELSUS oral semaglutide tablet" }, "route": { "zh": "口服（标签产品身份字段）", "en": "oral (label product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 0169-4303-30", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片司美格鲁肽 3 mg；30 片瓶装", "en": "Semaglutide 3 mg per tablet; 30-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=27f15fac-7d98-4114-a2ec-92494a91da98&name=Rybelsus_3mg_carton.jpg", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "司美格鲁肽", "en": "semaglutide" }, "value": 3, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、疗程、换算、联用或换药指令", "en": "labelled amount per tablet; not an individual's tablet count, course, conversion, co-use or switching instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-23", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 30, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "白色至浅黄色", "en": "white to light yellow" }, "shape": { "zh": "椭圆形片；无刻痕", "en": "oval tablet; no score" }, "imprint": "3 / novo", "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_305946981c84b1e4", "label": "DailyMed（NLM）：RYBELSUS / OZEMPIC 口服司美格鲁肽片当前公开标签（页面更新 2026-01-30；标签修订 2026-01）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=27f15fac-7d98-4114-a2ec-92494a91da98", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-rybelsus-oral-semaglutide-tablet-7mg-30-bottle-ndc-0169430730", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（页面更新 2026-01-30；标签修订 2026-01）；仅为所引公开标签展示面，不代表供应", "en": "Current U.S. DailyMed public label (page updated 30 Jan 2026; label revised Jan 2026); cited public label panel only, not availability" }, "dosageForm": { "zh": "RYBELSUS 司美格鲁肽口服片", "en": "RYBELSUS oral semaglutide tablet" }, "route": { "zh": "口服（标签产品身份字段）", "en": "oral (label product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 0169-4307-30", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片司美格鲁肽 7 mg；30 片瓶装", "en": "Semaglutide 7 mg per tablet; 30-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=27f15fac-7d98-4114-a2ec-92494a91da98&name=Rybelsus_7mg_carton.jpg", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "司美格鲁肽", "en": "semaglutide" }, "value": 7, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、疗程、换算、联用或换药指令", "en": "labelled amount per tablet; not an individual's tablet count, course, conversion, co-use or switching instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-23", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 30, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "白色至浅黄色", "en": "white to light yellow" }, "shape": { "zh": "椭圆形片；无刻痕", "en": "oval tablet; no score" }, "imprint": "7 / novo", "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_305946981c84b1e4", "label": "DailyMed（NLM）：RYBELSUS / OZEMPIC 口服司美格鲁肽片当前公开标签（页面更新 2026-01-30；标签修订 2026-01）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=27f15fac-7d98-4114-a2ec-92494a91da98", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-rybelsus-oral-semaglutide-tablet-14mg-30-bottle-ndc-0169431430", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（页面更新 2026-01-30；标签修订 2026-01）；仅为所引公开标签展示面，不代表供应", "en": "Current U.S. DailyMed public label (page updated 30 Jan 2026; label revised Jan 2026); cited public label panel only, not availability" }, "dosageForm": { "zh": "RYBELSUS 司美格鲁肽口服片", "en": "RYBELSUS oral semaglutide tablet" }, "route": { "zh": "口服（标签产品身份字段）", "en": "oral (label product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 0169-4314-30", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片司美格鲁肽 14 mg；30 片瓶装", "en": "Semaglutide 14 mg per tablet; 30-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=27f15fac-7d98-4114-a2ec-92494a91da98&name=Rybelsus_14mg_carton.jpg", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "司美格鲁肽", "en": "semaglutide" }, "value": 14, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、疗程、换算、联用或换药指令", "en": "labelled amount per tablet; not an individual's tablet count, course, conversion, co-use or switching instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-23", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 30, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "白色至浅黄色", "en": "white to light yellow" }, "shape": { "zh": "椭圆形片；无刻痕", "en": "oval tablet; no score" }, "imprint": "14 / novo", "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_305946981c84b1e4", "label": "DailyMed（NLM）：RYBELSUS / OZEMPIC 口服司美格鲁肽片当前公开标签（页面更新 2026-01-30；标签修订 2026-01）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=27f15fac-7d98-4114-a2ec-92494a91da98", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": null, "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=27f15fac-7d98-4114-a2ec-92494a91da98&name=Rybelsus_3mg_carton.jpg", "alt": "RYBELSUS 司美格鲁肽 3 mg、30 片、NDC 0169-4303-30 的美国 DailyMed 当前口服片纸盒面板", "archiveMarket": "美国", "labelVersion": "DailyMed SPL v13（2026-05-20 发布；标签修订 2026-01）", "presentation": "RYBELSUS 3 mg 口服片、NDC 0169-4303-30、30 片纸盒面板（当前美国 DailyMed 标签所列）。", "notice": "此图只对应 RYBELSUS、口服片、3 mg、NDC 0169-4303-30 与 30 片包装；不用于鉴定真伪，也不代表其他强度、R2 配方、OZEMPIC 口服片、OZEMPIC 注射剂、WEGOVY、其他市场或任何个人用药方案。", "source": { "id": "src_305946981c84b1e4", "label": "DailyMed（NLM）：RYBELSUS / OZEMPIC 口服司美格鲁肽片当前公开标签（页面更新 2026-01-30；标签修订 2026-01）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=27f15fac-7d98-4114-a2ec-92494a91da98", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "RYBELSUS 说明书放大阅读：口服片、配方与毫克数必须一起核对", "en": "RYBELSUS label reading: oral tablets, formulation and milligrams must be checked together" }, "summary": { "zh": "本模块以 FDA 2026 美国标签与 DailyMed 当前公开标签为阅读入口，帮助核对 RYBELSUS 的口服途径、完整品牌名、配方提示、每片标示强度和包装；它不提供个人起始、加量、补用、注射/口服转换或替换方案。", "en": "This module uses the FDA 2026 label and the current DailyMed public label as reading entries. It helps check RYBELSUS's oral route, full brand name, formulation cue, labelled strength per tablet and pack; it does not provide an individual starting, escalation, missed-use, injection-to-oral conversion or switching plan." }, "checks": [ { "zh": "先同时核对 RYBELSUS、司美格鲁肽、口服片、每片强度、包装和目标市场。通用名相同并不使它与 OZEMPIC 注射剂、WEGOVY 或另一种口服片成为可按名称或照片自行互换的同一产品。", "en": "Check RYBELSUS, semaglutide, oral tablet, labelled strength per tablet, pack and target market together. A shared generic name does not make it the same product as OZEMPIC injection, WEGOVY or another oral tablet for self-switching by name or photo." }, { "zh": "当前美国标签同时列出不同配方与不同片剂强度，并明确不能按毫克对毫克自行替换。包装上的数字是身份线索，不是自行换算、合并、掰开、补用或改用另一种产品的指令。", "en": "The current U.S. label lists different formulations and tablet strengths and states that they are not self-substitutable milligram for milligram. A number on the pack is an identity clue, not an instruction to convert, combine, split, make up or change products." }, { "zh": "“口服”也不表示可把它与其他口服药、饮料、进食时间或注射产品自行安排成固定方案。实际产品的现行标签、处方、全部药单和药师/开方团队指导必须一起核对。", "en": "“Oral” also does not provide a self-made schedule with other oral medicines, drinks, meals or an injection product. The current label for the actual product, prescription, complete medicine list and pharmacist/prescribing-team guidance must be reviewed together." }, { "zh": "持续呕吐、明显脱水、严重腹痛、低血糖样症状或对手上产品是否准确不确定时，应使用当地医疗渠道或咨询药师/开方团队；网页不替代紧急判断。", "en": "For persistent vomiting, marked dehydration, severe abdominal pain, low-glucose-like symptoms or uncertainty about the product in hand, use local medical channels or contact a pharmacist/prescribing team; a webpage does not replace urgent judgement." } ], "source": { "id": "src_800e1d05f1f277f1", "label": "FDA：RYBELSUS / OZEMPIC 口服司美格鲁肽片 2026 美国处方信息（NDA 213051）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/213051Orig1s030lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "口服司美格鲁肽怎样起作用：GLP-1 受体通路不等于可以自行换算产品", "en": "How oral semaglutide works: a GLP-1 pathway does not make products self-convertible" }, "summary": { "zh": "当前标签将口服司美格鲁肽描述为 GLP-1 类似物和 GLP-1 受体激动剂，并涉及葡萄糖依赖性胰岛素分泌、胰高血糖素分泌和胃排空等作用。这是机制概述，不是个人控糖结果、适用性、剂量、餐食安排或换药方案。", "en": "The current label describes oral semaglutide as a GLP-1 analogue and GLP-1 receptor agonist, involving glucose-dependent insulin secretion, glucagon secretion and gastric emptying. This is a mechanism overview, not an individual's glucose outcome, suitability, dose, meal plan or switching plan." }, "checks": [ { "zh": "GLP-1 是作用通路线索，不表示所有同类、同名或同通用名产品可自行叠加、隔天轮换或按总毫克数等量替换。", "en": "GLP-1 is an action-pathway clue; it does not make every same-class, same-name or same-generic product self-combinable, alternatable or milligram-equivalent." }, { "zh": "标签所述胃排空变化说明为什么同时使用的口服药和实际进食安排需要专业人员复核；它不能生成自行错开、停用、补用或调整其他药物的规则。", "en": "The label's discussion of gastric emptying explains why co-administered oral medicines and actual meal timing need professional review; it cannot generate self-made spacing, stopping, make-up or adjustment rules for other medicines." }, { "zh": "机制不是疗效或不良反应的个人预测。胃肠道症状、脱水、肾功能、其他降糖药和完整药单都需要回到准确产品的现行标签与专业评估。", "en": "Mechanism is not an individual prediction of benefit or adverse effects. Gastrointestinal symptoms, dehydration, kidney function, other glucose-lowering medicines and the complete medicine list require the current label for the exact product and professional assessment." } ], "source": { "id": "src_305946981c84b1e4", "label": "DailyMed（NLM）：RYBELSUS / OZEMPIC 口服司美格鲁肽片当前公开标签（临床药理）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=27f15fac-7d98-4114-a2ec-92494a91da98", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "Rybelsus", "generic": "司美格鲁肽", "dosageFormClass": "口服司美格鲁肽片剂；不同配方、强度与包装必须分别核对（美国 2026 当前标签）" }, "labelSource": { "id": "src_800e1d05f1f277f1", "label": "FDA：RYBELSUS / OZEMPIC 口服司美格鲁肽片 2026 美国处方信息（NDA 213051）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/213051Orig1s030lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "productRoutes": [ { "source": { "id": "src_800e1d05f1f277f1", "label": "FDA：RYBELSUS / OZEMPIC 口服司美格鲁肽片 2026 美国处方信息（NDA 213051）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/213051Orig1s030lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_305946981c84b1e4", "label": "DailyMed（NLM）：RYBELSUS / OZEMPIC 口服司美格鲁肽片当前公开标签（页面更新 2026-01-30；标签修订 2026-01）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=27f15fac-7d98-4114-a2ec-92494a91da98", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-23", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "DailyMed 的当前美国公开标签列有 RYBELSUS（semaglutide）3 mg、7 mg、14 mg 口服片。本页分别建立三种 30 片瓶装面板的品牌、通用名、每片标示量、NDC、外观线索和一手来源核对卡；不把包装数字变成个人片数、疗程、转换、联用或购买结论。", "history": "本页只建立当前 DailyMed 标签所列的 RYBELSUS 3 mg（NDC 0169-4303-30）、7 mg（NDC 0169-4307-30）和 14 mg（NDC 0169-4314-30）各 30 片瓶装身份。完整商品名、口服片、每片 mg、NDC、瓶装和目标市场须同时核对；共享通用名、相近数字或照片不能自行回答能否换用、联用、掰开、补用或改用另一种司美格鲁肽产品。", "sourceDocuments": [ { "id": "src_1e19329b60038cbf", "label": "FDA：RYBELSUS NDA 213051 原始批准资料（2019-09-20）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/213051Orig1s000Approv.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "approval_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_800e1d05f1f277f1", "label": "FDA：RYBELSUS / OZEMPIC 口服司美格鲁肽片 2026 美国处方信息（NDA 213051）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/213051Orig1s030lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_305946981c84b1e4", "label": "DailyMed（NLM）：RYBELSUS / OZEMPIC 口服司美格鲁肽片当前公开标签（页面更新 2026-01-30；标签修订 2026-01）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=27f15fac-7d98-4114-a2ec-92494a91da98", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, { "id": "src_5ed30b676fbb9773", "label": "FDA Drugs@FDA 官方检索入口", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_lookup_entry", "documentKind": "regulatory_lookup", "market": "US", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } ], "applicationNumber": "NDA 213051", "approvalTimeline": [ { "date": "2019-09-20", "title": { "zh": "RYBELSUS 原始美国批准", "en": "Original U.S. RYBELSUS approval" }, "detail": { "zh": "FDA 原始批准资料记录 RYBELSUS（司美格鲁肽口服片）NDA 213051 于 2019-09-20 获批。该历史节点不自动说明当前标签、供应、持有人或其他市场状态。", "en": "FDA original-approval material records approval of RYBELSUS (oral semaglutide tablets), NDA 213051, on 20 Sep 2019. This historical entry does not establish current labeling, availability, holder or another-market status." }, "source": { "id": "src_1e19329b60038cbf", "label": "FDA：RYBELSUS NDA 213051 原始批准资料（2019-09-20）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/213051Orig1s000Approv.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "approval_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, { "date": "2026-01", "title": { "zh": "FDA 当前口服片处方信息修订", "en": "FDA current oral-tablet prescribing information revised" }, "detail": { "zh": "本页链接的 FDA 处方信息标示修订于 2026-01，并将 RYBELSUS 与 OZEMPIC 口服片置于同一文件；必须核对完整品牌、口服片配方、强度、包装与目标市场，不能从共享通用名推定互换。", "en": "The linked FDA prescribing information is revised January 2026 and covers RYBELSUS and OZEMPIC tablets in one document. Check the complete brand, oral-tablet formulation, strength, pack and target market; a shared generic name does not establish interchangeability." }, "source": { "id": "src_800e1d05f1f277f1", "label": "FDA：RYBELSUS / OZEMPIC 口服司美格鲁肽片 2026 美国处方信息（NDA 213051）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/213051Orig1s030lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, { "date": "2026-05-20", "title": { "zh": "DailyMed 当前 SPL v13 公开", "en": "Current DailyMed SPL v13 published" }, "detail": { "zh": "DailyMed 媒体目录列示当前 SPL v13 于 2026-05-20 发布，并包含 RYBELSUS 准确 3 mg 纸盒面板。该日期与图片不表示其他包装、其他市场或实际可得性。", "en": "The DailyMed media listing shows current SPL v13 published on 20 May 2026 and includes the exact RYBELSUS 3 mg carton panel. That date and image do not establish another pack, another market or actual availability." }, "source": { "id": "src_bd3a04f8202e1084", "label": "DailyMed（NLM）：RYBELSUS / OZEMPIC 口服司美格鲁肽片当前公开标签（SPL v13，2026-05-20 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=27f15fac-7d98-4114-a2ec-92494a91da98", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "已链接 FDA 原始批准、当前口服片标签与一个精确 3 mg 纸盒面板", "en": "FDA original approval, current oral-tablet label and one exact 3 mg carton panel linked" }, "detail": { "zh": "展示图只对应 RYBELSUS 3 mg、NDC 0169-4303-30、30 片纸盒；不据此建立其他强度、R2 配方、OZEMPIC 口服片/注射剂、WEGOVY 或实际在售状态。", "en": "The image corresponds only to RYBELSUS 3 mg, NDC 0169-4303-30 and a 30-tablet carton; it does not establish other strengths, R2 formulation, OZEMPIC tablets/injection, WEGOVY or actual availability." } }, { "market": { "zh": "中国大陆、欧盟、日本及其他市场", "en": "Mainland China, EU, Japan and other markets" }, "status": { "zh": "待逐项建立市场记录", "en": "Market record not established" }, "detail": { "zh": "不从美国文件推定当地商品名、批准、包装、供应、原研关系或可替代性。", "en": "No local trade name, approval, pack, supply, originator relationship or interchangeability is inferred from U.S. documents." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "能否把 RYBELSUS 与任何 Ozempic 或 Wegovy 产品按毫克数互换？", "en": "Can RYBELSUS be exchanged milligram for milligram with any Ozempic or Wegovy product?" }, "answer": { "zh": "不能。本页只帮助区分产品身份；共享通用名、相近数字或包装照片不足以建立剂型、配方、给药途径或转换关系。请带准确包装和完整药单请药师/开方团队核对。", "en": "No. This page only distinguishes product identity; a shared generic name, similar numbers or package photo is insufficient to establish dosage form, formulation, route or conversion. Have a pharmacist or prescribing team review the exact pack and complete medicine list." } }, { "question": { "zh": "3 mg、7 mg、14 mg 或 R2 配方的数字是什么意思？", "en": "What do 3 mg, 7 mg, 14 mg or R2 formulation numbers mean?" }, "answer": { "zh": "它们是准确产品包装上的身份信息。当前标签同时提示不同配方和强度不能按毫克对毫克自行替换；网页不把这些数字变成任何人的片数、调整或转换方案。", "en": "They are identity information on the exact product pack. The current label also notes that formulations and strengths are not self-substitutable milligram for milligram; this page does not turn these numbers into anyone's tablet-count, adjustment or conversion plan." } } ], "relatedMedicineChecks": [ { "target": { "id": "ozempic", "brand": "Ozempic", "generic": "司美格鲁肽", "canonicalUrls": { "zh": "https://origindrug.com/drugs/ozempic/", "en": "https://origindrug.com/en/drugs/ozempic/" } }, "title": { "zh": "与 OZEMPIC／司美格鲁肽注射剂 同在药单上时：同含司美格鲁肽先做完整药单核对", "en": "When OZEMPIC / semaglutide injection is on the same list: products containing semaglutide need a complete medicine-list review" }, "summary": { "zh": "当前 DailyMed WEGOVY 美国公开标签的 Limitations of Use 提示：不建议将 WEGOVY 注射剂或片剂与其他含司美格鲁肽产品或其他 GLP-1 受体激动剂联用。这条来源限定的提示要求先把每个实际药盒、剂型、强度、处方、非处方药和补充剂交给药师或开方团队核对；它不判断个人能否同服，也不建议自行停用、错开时间、替换或调整任何一种药。", "en": "The current U.S. DailyMed WEGOVY public label states in Limitations of Use that concomitant use of WEGOVY injection or tablets with other semaglutide-containing products or any other GLP-1 receptor agonist is not recommended. This source-bounded cue means that every actual pack, dosage form, strength, prescription, OTC product and supplement should first be reviewed by a pharmacist or prescriber; it does not decide an individual's co-use or advise self-stopping, time-separation, replacement or adjustment of either medicine." }, "source": { "id": "src_aafb344bff238edf", "label": "DailyMed（NLM）：WEGOVY 当前美国公开标签（Limitations of Use：其他含司美格鲁肽产品／GLP-1 受体激动剂；SPL v19）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=ee06186f-2aa3-4990-a760-757579d8f77b", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "review_complete_medicine_list_no_self_directed_change" }, { "target": { "id": "wegovy", "brand": "Wegovy", "generic": "司美格鲁肽", "canonicalUrls": { "zh": "https://origindrug.com/drugs/wegovy/", "en": "https://origindrug.com/en/drugs/wegovy/" } }, "title": { "zh": "与 WEGOVY／司美格鲁肽产品 同在药单上时：同含司美格鲁肽先做完整药单核对", "en": "When WEGOVY / semaglutide product is on the same list: products containing semaglutide need a complete medicine-list review" }, "summary": { "zh": "当前 DailyMed WEGOVY 美国公开标签的 Limitations of Use 提示：不建议将 WEGOVY 注射剂或片剂与其他含司美格鲁肽产品或其他 GLP-1 受体激动剂联用。这条来源限定的提示要求先把每个实际药盒、剂型、强度、处方、非处方药和补充剂交给药师或开方团队核对；它不判断个人能否同服，也不建议自行停用、错开时间、替换或调整任何一种药。", "en": "The current U.S. DailyMed WEGOVY public label states in Limitations of Use that concomitant use of WEGOVY injection or tablets with other semaglutide-containing products or any other GLP-1 receptor agonist is not recommended. This source-bounded cue means that every actual pack, dosage form, strength, prescription, OTC product and supplement should first be reviewed by a pharmacist or prescriber; it does not decide an individual's co-use or advise self-stopping, time-separation, replacement or adjustment of either medicine." }, "source": { "id": "src_aafb344bff238edf", "label": "DailyMed（NLM）：WEGOVY 当前美国公开标签（Limitations of Use：其他含司美格鲁肽产品／GLP-1 受体激动剂；SPL v19）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=ee06186f-2aa3-4990-a760-757579d8f77b", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "review_complete_medicine_list_no_self_directed_change" } ], "relatedArticleSlugs": [ "dosage-forms-are-part-of-medicine-identity", "medicine-label-for-everyday-questions", "how-to-read-a-drug-label" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/rybelsus/", "en": "https://origindrug.com/en/drugs/rybelsus/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "wegovy", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-25", "status": "published_traceable_archive" }, "names": { "brand": "Wegovy", "generic": "司美格鲁肽", "aliases": [ "semaglutide" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "代谢", "sourceArchiveMarket": "美国 DailyMed 当前公开标签（SPL v19，2026-06-18 生效）。本页逐项建立 6 个单剂量预充注射器与 4 个 30 片装口服片身份；FlexTouch 等其他装置或包装须另行核对。", "dosageFormClass": "司美格鲁肽单剂量预充注射器：0.25、0.5、1 mg/0.5 mL，1.7、2.4、7.2 mg/0.75 mL；口服片：1.5、4、9、25 mg。皮下与口服是不同产品身份。", "dosageFormClassCode": "multiple_forms_and_routes", "route": "皮下 / 口服", "routeCode": "multiple", "historicalApprovalEntry": "2017（DailyMed 当前美国标签所列美国初始批准）", "archiveSponsorText": "Novo Nordisk Pharmaceutical Industries, LP / DailyMed（NLM）当前美国公开标签" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-wegovy-semaglutide-single-dose-prefilled-syringe-0-25mg-0-5ml-4-carton-ndc-0169452514", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（SPL v19，2026-06-18 生效）；仅为所引公开标签产品身份，不代表供应", "en": "Current U.S. DailyMed public label (SPL v19, effective 18 Jun 2026); cited product identity only, not availability" }, "dosageForm": { "zh": "WEGOVY 司美格鲁肽单剂量预充注射器", "en": "WEGOVY single-dose prefilled semaglutide syringe" }, "route": { "zh": "皮下（标签产品身份字段）", "en": "subcutaneous (label product-identity field)" }, "routeCodes": [ "subcutaneous" ], "productCode": "NDC 0169-4525-14", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_single_dose_prefilled_syringe", "primaryDisplay": { "zh": "0.25 mg/0.5 mL／每支单剂量预充注射器；4 支纸盒装", "en": "0.25 mg/0.5 mL per single-dose prefilled syringe; carton of 4 syringes" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=Carton-0-25.jpg&id=959368", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "司美格鲁肽", "en": "semaglutide" }, "value": 0.25, "unit": "mg", "basisCode": "per_single_dose_prefilled_syringe", "basisLabel": { "zh": "每支单剂量预充注射器的标签标示量；不是个人注射量、频率、补用、转换或换药指令", "en": "labelled amount in one single-dose prefilled syringe; not an individual's injection amount, frequency, missed-use, conversion or switching instruction" } } ], "concentration": { "basisCode": "mg_per_stated_syringe_volume", "notation": null, "numerator": { "value": 0.25, "unit": "mg" }, "denominator": { "value": 0.5, "unit": "mL" }, "display": { "zh": "0.25 mg/0.5 mL（该支注射器标签量；不是个人注射量）", "en": "0.25 mg/0.5 mL (labelled amount in the stated syringe; not an individual injection amount)" } }, "container": { "typeCode": "single_dose_prefilled_syringe", "typeLabel": { "zh": "单剂量预充注射器", "en": "single-dose prefilled syringe" }, "fill": { "value": 0.5, "unit": "mL" }, "countPerPackage": 4, "countUnit": { "zh": "支/纸盒", "en": "syringes per carton" } }, "deliveryDevice": { "typeCode": "single_dose_prefilled_syringe", "name": { "zh": "单剂量预充注射器", "en": "single-dose prefilled syringe" } }, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-25", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 4, "unit": { "zh": "支单剂量预充注射器/纸盒", "en": "single-dose prefilled syringes per carton" } }, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_aafb344bff238edf", "label": "DailyMed（NLM）：WEGOVY 司美格鲁肽注射剂与口服片当前美国公开标签（Novo Nordisk；SPL v19，2026-06-18 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=ee06186f-2aa3-4990-a760-757579d8f77b", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-wegovy-semaglutide-single-dose-prefilled-syringe-0-5mg-0-5ml-4-carton-ndc-0169450514", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（SPL v19，2026-06-18 生效）；仅为所引公开标签产品身份，不代表供应", "en": "Current U.S. DailyMed public label (SPL v19, effective 18 Jun 2026); cited product identity only, not availability" }, "dosageForm": { "zh": "WEGOVY 司美格鲁肽单剂量预充注射器", "en": "WEGOVY single-dose prefilled semaglutide syringe" }, "route": { "zh": "皮下（标签产品身份字段）", "en": "subcutaneous (label product-identity field)" }, "routeCodes": [ "subcutaneous" ], "productCode": "NDC 0169-4505-14", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_single_dose_prefilled_syringe", "primaryDisplay": { "zh": "0.5 mg/0.5 mL／每支单剂量预充注射器；4 支纸盒装", "en": "0.5 mg/0.5 mL per single-dose prefilled syringe; carton of 4 syringes" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=Carton-0-5.jpg&id=959368", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "司美格鲁肽", "en": "semaglutide" }, "value": 0.5, "unit": "mg", "basisCode": "per_single_dose_prefilled_syringe", "basisLabel": { "zh": "每支单剂量预充注射器的标签标示量；不是个人注射量、频率、补用、转换或换药指令", "en": "labelled amount in one single-dose prefilled syringe; not an individual's injection amount, frequency, missed-use, conversion or switching instruction" } } ], "concentration": { "basisCode": "mg_per_stated_syringe_volume", "notation": null, "numerator": { "value": 0.5, "unit": "mg" }, "denominator": { "value": 0.5, "unit": "mL" }, "display": { "zh": "0.5 mg/0.5 mL（该支注射器标签量；不是个人注射量）", "en": "0.5 mg/0.5 mL (labelled amount in the stated syringe; not an individual injection amount)" } }, "container": { "typeCode": "single_dose_prefilled_syringe", "typeLabel": { "zh": "单剂量预充注射器", "en": "single-dose prefilled syringe" }, "fill": { "value": 0.5, "unit": "mL" }, "countPerPackage": 4, "countUnit": { "zh": "支/纸盒", "en": "syringes per carton" } }, "deliveryDevice": { "typeCode": "single_dose_prefilled_syringe", "name": { "zh": "单剂量预充注射器", "en": "single-dose prefilled syringe" } }, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-25", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 4, "unit": { "zh": "支单剂量预充注射器/纸盒", "en": "single-dose prefilled syringes per carton" } }, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_aafb344bff238edf", "label": "DailyMed（NLM）：WEGOVY 司美格鲁肽注射剂与口服片当前美国公开标签（Novo Nordisk；SPL v19，2026-06-18 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=ee06186f-2aa3-4990-a760-757579d8f77b", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-wegovy-semaglutide-single-dose-prefilled-syringe-1mg-0-5ml-4-carton-ndc-0169450114", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（SPL v19，2026-06-18 生效）；仅为所引公开标签产品身份，不代表供应", "en": "Current U.S. DailyMed public label (SPL v19, effective 18 Jun 2026); cited product identity only, not availability" }, "dosageForm": { "zh": "WEGOVY 司美格鲁肽单剂量预充注射器", "en": "WEGOVY single-dose prefilled semaglutide syringe" }, "route": { "zh": "皮下（标签产品身份字段）", "en": "subcutaneous (label product-identity field)" }, "routeCodes": [ "subcutaneous" ], "productCode": "NDC 0169-4501-14", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_single_dose_prefilled_syringe", "primaryDisplay": { "zh": "1 mg/0.5 mL／每支单剂量预充注射器；4 支纸盒装", "en": "1 mg/0.5 mL per single-dose prefilled syringe; carton of 4 syringes" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=Carton-1mg.jpg&id=959368", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "司美格鲁肽", "en": "semaglutide" }, "value": 1, "unit": "mg", "basisCode": "per_single_dose_prefilled_syringe", "basisLabel": { "zh": "每支单剂量预充注射器的标签标示量；不是个人注射量、频率、补用、转换或换药指令", "en": "labelled amount in one single-dose prefilled syringe; not an individual's injection amount, frequency, missed-use, conversion or switching instruction" } } ], "concentration": { "basisCode": "mg_per_stated_syringe_volume", "notation": null, "numerator": { "value": 1, "unit": "mg" }, "denominator": { "value": 0.5, "unit": "mL" }, "display": { "zh": "1 mg/0.5 mL（该支注射器标签量；不是个人注射量）", "en": "1 mg/0.5 mL (labelled amount in the stated syringe; not an individual injection amount)" } }, "container": { "typeCode": "single_dose_prefilled_syringe", "typeLabel": { "zh": "单剂量预充注射器", "en": "single-dose prefilled syringe" }, "fill": { "value": 0.5, "unit": "mL" }, "countPerPackage": 4, "countUnit": { "zh": "支/纸盒", "en": "syringes per carton" } }, "deliveryDevice": { "typeCode": "single_dose_prefilled_syringe", "name": { "zh": "单剂量预充注射器", "en": "single-dose prefilled syringe" } }, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-25", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 4, "unit": { "zh": "支单剂量预充注射器/纸盒", "en": "single-dose prefilled syringes per carton" } }, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_aafb344bff238edf", "label": "DailyMed（NLM）：WEGOVY 司美格鲁肽注射剂与口服片当前美国公开标签（Novo Nordisk；SPL v19，2026-06-18 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=ee06186f-2aa3-4990-a760-757579d8f77b", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-wegovy-semaglutide-single-dose-prefilled-syringe-1-7mg-0-75ml-4-carton-ndc-0169451714", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（SPL v19，2026-06-18 生效）；仅为所引公开标签产品身份，不代表供应", "en": "Current U.S. DailyMed public label (SPL v19, effective 18 Jun 2026); cited product identity only, not availability" }, "dosageForm": { "zh": "WEGOVY 司美格鲁肽单剂量预充注射器", "en": "WEGOVY single-dose prefilled semaglutide syringe" }, "route": { "zh": "皮下（标签产品身份字段）", "en": "subcutaneous (label product-identity field)" }, "routeCodes": [ "subcutaneous" ], "productCode": "NDC 0169-4517-14", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_single_dose_prefilled_syringe", "primaryDisplay": { "zh": "1.7 mg/0.75 mL／每支单剂量预充注射器；4 支纸盒装", "en": "1.7 mg/0.75 mL per single-dose prefilled syringe; carton of 4 syringes" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=Carton-1-7.jpg&id=959368", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "司美格鲁肽", "en": "semaglutide" }, "value": 1.7, "unit": "mg", "basisCode": "per_single_dose_prefilled_syringe", "basisLabel": { "zh": "每支单剂量预充注射器的标签标示量；不是个人注射量、频率、补用、转换或换药指令", "en": "labelled amount in one single-dose prefilled syringe; not an individual's injection amount, frequency, missed-use, conversion or switching instruction" } } ], "concentration": { "basisCode": "mg_per_stated_syringe_volume", "notation": null, "numerator": { "value": 1.7, "unit": "mg" }, "denominator": { "value": 0.75, "unit": "mL" }, "display": { "zh": "1.7 mg/0.75 mL（该支注射器标签量；不是个人注射量）", "en": "1.7 mg/0.75 mL (labelled amount in the stated syringe; not an individual injection amount)" } }, "container": { "typeCode": "single_dose_prefilled_syringe", "typeLabel": { "zh": "单剂量预充注射器", "en": "single-dose prefilled syringe" }, "fill": { "value": 0.75, "unit": "mL" }, "countPerPackage": 4, "countUnit": { "zh": "支/纸盒", "en": "syringes per carton" } }, "deliveryDevice": { "typeCode": "single_dose_prefilled_syringe", "name": { "zh": "单剂量预充注射器", "en": "single-dose prefilled syringe" } }, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-25", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 4, "unit": { "zh": "支单剂量预充注射器/纸盒", "en": "single-dose prefilled syringes per carton" } }, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_aafb344bff238edf", "label": "DailyMed（NLM）：WEGOVY 司美格鲁肽注射剂与口服片当前美国公开标签（Novo Nordisk；SPL v19，2026-06-18 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=ee06186f-2aa3-4990-a760-757579d8f77b", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-wegovy-semaglutide-single-dose-prefilled-syringe-2-4mg-0-75ml-4-carton-ndc-0169452414", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（SPL v19，2026-06-18 生效）；仅为所引公开标签产品身份，不代表供应", "en": "Current U.S. DailyMed public label (SPL v19, effective 18 Jun 2026); cited product identity only, not availability" }, "dosageForm": { "zh": "WEGOVY 司美格鲁肽单剂量预充注射器", "en": "WEGOVY single-dose prefilled semaglutide syringe" }, "route": { "zh": "皮下（标签产品身份字段）", "en": "subcutaneous (label product-identity field)" }, "routeCodes": [ "subcutaneous" ], "productCode": "NDC 0169-4524-14", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_single_dose_prefilled_syringe", "primaryDisplay": { "zh": "2.4 mg/0.75 mL／每支单剂量预充注射器；4 支纸盒装", "en": "2.4 mg/0.75 mL per single-dose prefilled syringe; carton of 4 syringes" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=Carton-2-4.jpg&id=959368", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "司美格鲁肽", "en": "semaglutide" }, "value": 2.4, "unit": "mg", "basisCode": "per_single_dose_prefilled_syringe", "basisLabel": { "zh": "每支单剂量预充注射器的标签标示量；不是个人注射量、频率、补用、转换或换药指令", "en": "labelled amount in one single-dose prefilled syringe; not an individual's injection amount, frequency, missed-use, conversion or switching instruction" } } ], "concentration": { "basisCode": "mg_per_stated_syringe_volume", "notation": null, "numerator": { "value": 2.4, "unit": "mg" }, "denominator": { "value": 0.75, "unit": "mL" }, "display": { "zh": "2.4 mg/0.75 mL（该支注射器标签量；不是个人注射量）", "en": "2.4 mg/0.75 mL (labelled amount in the stated syringe; not an individual injection amount)" } }, "container": { "typeCode": "single_dose_prefilled_syringe", "typeLabel": { "zh": "单剂量预充注射器", "en": "single-dose prefilled syringe" }, "fill": { "value": 0.75, "unit": "mL" }, "countPerPackage": 4, "countUnit": { "zh": "支/纸盒", "en": "syringes per carton" } }, "deliveryDevice": { "typeCode": "single_dose_prefilled_syringe", "name": { "zh": "单剂量预充注射器", "en": "single-dose prefilled syringe" } }, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-25", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 4, "unit": { "zh": "支单剂量预充注射器/纸盒", "en": "single-dose prefilled syringes per carton" } }, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_aafb344bff238edf", "label": "DailyMed（NLM）：WEGOVY 司美格鲁肽注射剂与口服片当前美国公开标签（Novo Nordisk；SPL v19，2026-06-18 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=ee06186f-2aa3-4990-a760-757579d8f77b", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-wegovy-semaglutide-single-dose-prefilled-syringe-7-2mg-0-75ml-4-carton-ndc-0169457214", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（SPL v19，2026-06-18 生效）；仅为所引公开标签产品身份，不代表供应", "en": "Current U.S. DailyMed public label (SPL v19, effective 18 Jun 2026); cited product identity only, not availability" }, "dosageForm": { "zh": "WEGOVY 司美格鲁肽单剂量预充注射器", "en": "WEGOVY single-dose prefilled semaglutide syringe" }, "route": { "zh": "皮下（标签产品身份字段）", "en": "subcutaneous (label product-identity field)" }, "routeCodes": [ "subcutaneous" ], "productCode": "NDC 0169-4572-14", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_single_dose_prefilled_syringe", "primaryDisplay": { "zh": "7.2 mg/0.75 mL／每支单剂量预充注射器；4 支纸盒装", "en": "7.2 mg/0.75 mL per single-dose prefilled syringe; carton of 4 syringes" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "司美格鲁肽", "en": "semaglutide" }, "value": 7.2, "unit": "mg", "basisCode": "per_single_dose_prefilled_syringe", "basisLabel": { "zh": "每支单剂量预充注射器的标签标示量；不是个人注射量、频率、补用、转换或换药指令", "en": "labelled amount in one single-dose prefilled syringe; not an individual's injection amount, frequency, missed-use, conversion or switching instruction" } } ], "concentration": { "basisCode": "mg_per_stated_syringe_volume", "notation": null, "numerator": { "value": 7.2, "unit": "mg" }, "denominator": { "value": 0.75, "unit": "mL" }, "display": { "zh": "7.2 mg/0.75 mL（该支注射器标签量；不是个人注射量）", "en": "7.2 mg/0.75 mL (labelled amount in the stated syringe; not an individual injection amount)" } }, "container": { "typeCode": "single_dose_prefilled_syringe", "typeLabel": { "zh": "单剂量预充注射器", "en": "single-dose prefilled syringe" }, "fill": { "value": 0.75, "unit": "mL" }, "countPerPackage": 4, "countUnit": { "zh": "支/纸盒", "en": "syringes per carton" } }, "deliveryDevice": { "typeCode": "single_dose_prefilled_syringe", "name": { "zh": "单剂量预充注射器", "en": "single-dose prefilled syringe" } }, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-25", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 4, "unit": { "zh": "支单剂量预充注射器/纸盒", "en": "single-dose prefilled syringes per carton" } }, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_aafb344bff238edf", "label": "DailyMed（NLM）：WEGOVY 司美格鲁肽注射剂与口服片当前美国公开标签（Novo Nordisk；SPL v19，2026-06-18 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=ee06186f-2aa3-4990-a760-757579d8f77b", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-wegovy-semaglutide-oral-tablet-1-5mg-30-bottle-ndc-0169441531", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（SPL v19，2026-06-18 生效）；仅为所引公开标签产品身份，不代表供应", "en": "Current U.S. DailyMed public label (SPL v19, effective 18 Jun 2026); cited product identity only, not availability" }, "dosageForm": { "zh": "WEGOVY 司美格鲁肽口服片", "en": "WEGOVY oral semaglutide tablet" }, "route": { "zh": "口服（标签产品身份字段）", "en": "oral (label product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 0169-4415-31", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片司美格鲁肽 1.5 mg；30 片瓶装", "en": "Semaglutide 1.5 mg per tablet; 30-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=image-10.jpg&id=959368", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "司美格鲁肽", "en": "semaglutide" }, "value": 1.5, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、疗程、转换或换药指令", "en": "labelled amount per tablet; not an individual's tablet count, course, conversion or switching instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "塑料瓶", "en": "plastic bottle" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-25", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 30, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "白色至浅黄色", "en": "white to light yellow" }, "shape": { "zh": "圆形片；无刻痕", "en": "round tablet; unscored" }, "imprint": "1.5 / novo", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_aafb344bff238edf", "label": "DailyMed（NLM）：WEGOVY 司美格鲁肽注射剂与口服片当前美国公开标签（Novo Nordisk；SPL v19，2026-06-18 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=ee06186f-2aa3-4990-a760-757579d8f77b", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-wegovy-semaglutide-oral-tablet-4mg-30-bottle-ndc-0169440431", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（SPL v19，2026-06-18 生效）；仅为所引公开标签产品身份，不代表供应", "en": "Current U.S. DailyMed public label (SPL v19, effective 18 Jun 2026); cited product identity only, not availability" }, "dosageForm": { "zh": "WEGOVY 司美格鲁肽口服片", "en": "WEGOVY oral semaglutide tablet" }, "route": { "zh": "口服（标签产品身份字段）", "en": "oral (label product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 0169-4404-31", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片司美格鲁肽 4 mg；30 片瓶装", "en": "Semaglutide 4 mg per tablet; 30-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=Wegovy_Tablets_4mg_Carton.jpg&id=959368", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "司美格鲁肽", "en": "semaglutide" }, "value": 4, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、疗程、转换或换药指令", "en": "labelled amount per tablet; not an individual's tablet count, course, conversion or switching instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "塑料瓶", "en": "plastic bottle" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-25", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 30, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "白色至浅黄色", "en": "white to light yellow" }, "shape": { "zh": "圆形片；无刻痕", "en": "round tablet; unscored" }, "imprint": "4 / novo", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_aafb344bff238edf", "label": "DailyMed（NLM）：WEGOVY 司美格鲁肽注射剂与口服片当前美国公开标签（Novo Nordisk；SPL v19，2026-06-18 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=ee06186f-2aa3-4990-a760-757579d8f77b", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-wegovy-semaglutide-oral-tablet-9mg-30-bottle-ndc-0169440931", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（SPL v19，2026-06-18 生效）；仅为所引公开标签产品身份，不代表供应", "en": "Current U.S. DailyMed public label (SPL v19, effective 18 Jun 2026); cited product identity only, not availability" }, "dosageForm": { "zh": "WEGOVY 司美格鲁肽口服片", "en": "WEGOVY oral semaglutide tablet" }, "route": { "zh": "口服（标签产品身份字段）", "en": "oral (label product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 0169-4409-31", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片司美格鲁肽 9 mg；30 片瓶装", "en": "Semaglutide 9 mg per tablet; 30-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=Wegovy_Tablets_9mg_Carton.jpg&id=959368", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "司美格鲁肽", "en": "semaglutide" }, "value": 9, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、疗程、转换或换药指令", "en": "labelled amount per tablet; not an individual's tablet count, course, conversion or switching instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "塑料瓶", "en": "plastic bottle" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-25", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 30, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "白色至浅黄色", "en": "white to light yellow" }, "shape": { "zh": "圆形片；无刻痕", "en": "round tablet; unscored" }, "imprint": "9 / novo", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_aafb344bff238edf", "label": "DailyMed（NLM）：WEGOVY 司美格鲁肽注射剂与口服片当前美国公开标签（Novo Nordisk；SPL v19，2026-06-18 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=ee06186f-2aa3-4990-a760-757579d8f77b", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-wegovy-semaglutide-oral-tablet-25mg-30-bottle-ndc-0169442531", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（SPL v19，2026-06-18 生效）；仅为所引公开标签产品身份，不代表供应", "en": "Current U.S. DailyMed public label (SPL v19, effective 18 Jun 2026); cited product identity only, not availability" }, "dosageForm": { "zh": "WEGOVY 司美格鲁肽口服片", "en": "WEGOVY oral semaglutide tablet" }, "route": { "zh": "口服（标签产品身份字段）", "en": "oral (label product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 0169-4425-31", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片司美格鲁肽 25 mg；30 片瓶装", "en": "Semaglutide 25 mg per tablet; 30-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=Wegovy_Tablets_25mg_Carton.jpg&id=959368", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "司美格鲁肽", "en": "semaglutide" }, "value": 25, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、疗程、转换或换药指令", "en": "labelled amount per tablet; not an individual's tablet count, course, conversion or switching instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "塑料瓶", "en": "plastic bottle" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-25", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 30, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "白色至浅黄色", "en": "white to light yellow" }, "shape": { "zh": "椭圆形片；无刻痕", "en": "oval tablet; unscored" }, "imprint": "25 / novo", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_aafb344bff238edf", "label": "DailyMed（NLM）：WEGOVY 司美格鲁肽注射剂与口服片当前美国公开标签（Novo Nordisk；SPL v19，2026-06-18 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=ee06186f-2aa3-4990-a760-757579d8f77b", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": null, "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=Carton-0-25.jpg&setid=ee06186f-2aa3-4990-a760-757579d8f77b&type=img", "alt": "WEGOVY 0.25 mg/0.5 mL 单剂量预充注射器在美国 DailyMed 公开标签中的纸盒展开图", "archiveMarket": "美国", "labelVersion": "2026-06", "presentation": "WEGOVY 0.25 mg/0.5 mL、4 支单剂量预充注射器纸盒展开图（DailyMed 页面所列 2026-06 更新标签）。", "notice": "此为美国 DailyMed 公开标签中明确对应 WEGOVY 0.25 mg/0.5 mL 单剂量预充注射器的纸盒文字图，只帮助核对品牌、通用名、标示强度、给药途径、包装形式和来源；不用于鉴定真伪，也不证明其他强度、口服片、其他市场标签、当前包装、目标市场批准或可售资格。", "source": { "id": "src_aafb344bff238edf", "label": "DailyMed（NLM）：WEGOVY 公开标签（SPL v19，2026-06-18 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=ee06186f-2aa3-4990-a760-757579d8f77b", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "WEGOVY 说明书放大阅读：同名不等于同一种给药产品", "en": "WEGOVY label reading: the same name does not mean the same administration product" }, "summary": { "zh": "本模块以当前 DailyMed 美国公开标签为阅读入口，帮助分开核对 WEGOVY 的商品名、给药途径、强度单位和包装形式；它不提供个人起始、加量、补用或替换方案。", "en": "This module uses the current U.S. DailyMed public label as a reading entry point. It helps separate WEGOVY’s name, route, strength unit and package form; it does not provide an individual starting, escalation, missed-dose or substitution plan." }, "checks": [ { "zh": "先把“皮下注射”或“口服”、具体产品强度、包装形式和目标市场一起核对。即使商品名与通用名相同，不同给药途径也不是可以只按名称、照片或总毫克数自动互换的同一产品。", "en": "Check “subcutaneous injection” or “oral”, the exact product strength, package form and target market together. Even with the same brand and generic name, different routes are not the same product to interchange by name, photo or total milligrams alone." }, { "zh": "注射产品中“mg/0.5 mL”或“mg/0.75 mL”同时包含每次给药装置中的药物量与液体体积；它不是“每天该打多少”的答案。口服片剂上的 mg 也必须按该准确产品的现行标签、处方和专业指导单独核对。", "en": "For injection products, “mg/0.5 mL” or “mg/0.75 mL” contains both the medicine amount and liquid volume in the stated device; it is not an answer to how much anyone should inject. Milligrams on an oral tablet also require separate checking against that exact product’s current label, prescription and professional guidance." }, { "zh": "注射笔、单剂量装置、口服片及不同强度的包装文字，都是产品身份线索，不是用于自行调整频率、补用、两次合并、拆分或改用另一种司美格鲁肽产品的指令。", "en": "Pen, single-dose device, oral-tablet and different-strength package wording are product-identity clues, not instructions to independently change frequency, make up, combine, split or change to another semaglutide product." }, { "zh": "若同时使用降糖药、存在脱水或胃肠道症状、计划操作，或对注射/口服转换有疑问，应带完整药单与实际包装请开方团队或药师核对；不要从网页推断个体适用性。", "en": "If other glucose-lowering medicines are used, dehydration or gastrointestinal symptoms occur, a procedure is planned, or an injection/oral change is being considered, bring the complete medicine list and actual package to the prescribing team or pharmacist; do not infer individual suitability from a webpage." } ], "source": { "id": "src_aafb344bff238edf", "label": "DailyMed（NLM）：WEGOVY 公开标签", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=ee06186f-2aa3-4990-a760-757579d8f77b", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "司美格鲁肽怎样起作用：它激活 GLP-1 受体并参与食欲与能量摄入调节", "en": "How semaglutide works: it activates the GLP-1 receptor and participates in appetite and energy-intake regulation" }, "summary": { "zh": "DailyMed 的 WEGOVY 公开标签将司美格鲁肽描述为 GLP-1 类似物和 GLP-1 受体激动剂；GLP-1 是参与食欲与能量摄入调节的生理信号。标签还描述其可延缓胃排空，并以葡萄糖依赖方式促进胰岛素分泌、减少胰高血糖素分泌。这是机制概述，不是个人是否适用、用哪种给药途径、使用强度或调整频率的答案。", "en": "The public DailyMed WEGOVY label describes semaglutide as a GLP-1 analogue and GLP-1 receptor agonist; GLP-1 is a physiological signal involved in appetite and energy-intake regulation. The label also describes delayed gastric emptying and glucose-dependent stimulation of insulin secretion with reduced glucagon secretion. This is a mechanism overview, not an answer to individual suitability, route, strength or frequency adjustment." }, "checks": [ { "zh": "“影响食欲”不能被读成每个人都应使用、应少吃多少或能据此自行加量。体重、胃肠道反应、营养摄入、共病和全部用药都需要回到具体产品的现行标签、处方与专业评估。", "en": "“Affects appetite” cannot be read as everyone should use the product, should eat a certain amount less, or may self-increase it. Weight, gastrointestinal effects, nutrition intake, coexisting conditions and every medicine need the current label, prescription and professional assessment for the exact product." }, { "zh": "标签的“延缓胃排空”是理解为何口服药联用需要核对的一条线索；它不能给出自行错开时间、停用口服药、把注射产品与口服产品等量换算或把另一种 GLP-1 产品叠加的方案。", "en": "The label's “delays gastric emptying” is one clue for why oral co-medications need review; it cannot provide a self-made spacing schedule, stopping plan for oral medicines, equal conversion between injection and oral products, or a plan to add another GLP-1 product." }, { "zh": "同一通用名下，预充笔、预充注射器、FlexTouch 装置和口服片属于不同产品身份层面。即使药理机制相同，也必须逐项核对给药途径、装置、强度、目标市场与完整药单，不能按总毫克数自行替换。", "en": "Under the same generic name, prefilled pens, prefilled syringes, FlexTouch devices and oral tablets are different product-identity layers. Even with the same pharmacology, route, device, strength, target market and complete medicine list must be checked item by item; total milligrams do not permit self-substitution." } ], "source": { "id": "src_aafb344bff238edf", "label": "DailyMed（NLM）：WEGOVY 公开标签（SPL v19，临床药理）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=ee06186f-2aa3-4990-a760-757579d8f77b", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "Wegovy", "generic": "司美格鲁肽", "dosageFormClass": "司美格鲁肽单剂量预充注射器：0.25、0.5、1 mg/0.5 mL，1.7、2.4、7.2 mg/0.75 mL；口服片：1.5、4、9、25 mg。皮下与口服是不同产品身份。" }, "labelSource": { "id": "src_aafb344bff238edf", "label": "DailyMed（NLM）：WEGOVY 公开标签（SPL v19，2026-06-18 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=ee06186f-2aa3-4990-a760-757579d8f77b", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "productRoutes": [ { "source": { "id": "src_aafb344bff238edf", "label": "DailyMed（NLM）：WEGOVY 公开标签（SPL v19，2026-06-18 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=ee06186f-2aa3-4990-a760-757579d8f77b", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_447c469410146fe0", "label": "FDA：WEGOVY 2025 美国标签（NDA 215256；当前标签以 DailyMed SPL v19 复核）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/215256s026lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [ { "id": "fda-2026-wegovy-glp1-suicidal-ideation-label-safety-communication", "issuedAt": "2026-01-13", "status": "fda_drug_safety_communication", "title": { "zh": "FDA 药物安全通讯：Wegovy 等 GLP-1 受体激动剂的相关标签信息调整", "en": "FDA Drug Safety Communication: related labelling change for Wegovy and other GLP-1 receptor agonists" }, "summary": { "zh": "FDA 于 2026-01-13 发布安全通讯，要求对 Wegovy（司美格鲁肽）、Saxenda 和 Zepbound 的处方信息移除既有的自杀意念/行为风险信息；FDA 表示其综合审查未发现 GLP-1 受体激动剂使用与该风险增加相关。该通讯仅说明美国监管行动及其适用产品，不能替代手中产品、目标市场现行说明书或个人精神健康评估；如有新的或加重的情绪、行为或自伤想法，应立即联系当地紧急/医疗支持，而非自行改变药物。", "en": "On 2026-01-13, FDA issued a Drug Safety Communication requesting removal of existing suicidal-ideation/behavior language from prescribing information for Wegovy (semaglutide), Saxenda and Zepbound; FDA said its comprehensive review did not identify an increased risk with GLP-1 receptor agonists. The communication describes a U.S. regulatory action and named products only. It does not replace the exact product, current target-market label or an individual mental-health assessment; new or worsening mood, behavior or self-harm thoughts require prompt local emergency or clinical support, not self-directed medicine changes." }, "source": { "id": "src_beb7f5a3f892688f", "label": "FDA：2026-01-13 Wegovy 等 GLP-1 受体激动剂药物安全通讯", "url": "https://www.fda.gov/drugs/drug-safety-communications/fda-requests-removal-suicidal-behavior-and-ideation-warning-glucagon-peptide-1-receptor-agonist-glp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "美国 DailyMed 当前标签在同一 WEGOVY 品牌下列有皮下注射与口服片。本页将 6 个单剂量预充注射器和 4 个 30 片装口服片分别列出品牌、通用名、途径、标签量、NDC、容器与来源，帮助先确认手中产品。它不把 mg、mg/mL、包装数量或同一成分变成个人注射量、片数、转换、联用或换药结论。", "history": "同一商品名下的不同给药途径、容器、强度和包装不能只按通用名、名称、照片或数字自动等同。本文所列单剂量预充注射器与口服片是不同的标签产品身份；FlexTouch 等其他装置或包装也必须逐项按目标市场现行标签核验。", "sourceDocuments": [ { "id": "src_447c469410146fe0", "label": "FDA：WEGOVY 2025 美国标签（NDA 215256；当前标签以 DailyMed SPL v19 复核）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/215256s026lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_aafb344bff238edf", "label": "DailyMed（NLM）：WEGOVY 公开标签（SPL v19，2026-06-18 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=ee06186f-2aa3-4990-a760-757579d8f77b", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_5ed30b676fbb9773", "label": "FDA Drugs@FDA 官方检索入口", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_lookup_entry", "documentKind": "regulatory_lookup", "market": "US", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } ], "applicationNumber": "NDA 215256", "approvalTimeline": [ { "date": "SPL v19, effective 2026-06-18", "title": { "zh": "当前美国公开标签的日期记录", "en": "Dated current U.S. public-label record" }, "detail": { "zh": "本页链接 SPL v19, effective 2026-06-18 的当前美国公开标签，作为放大阅读和逐项核对入口。它不替代目标市场当日的批准、供应、适应症、规格或个体化用药判断。", "en": "This page links the current U.S. public label dated SPL v19, effective 2026-06-18 as an enlarged-reading and item-by-item checking entry point. It does not replace same-day verification of approval, supply, indication, strength or individual use in the target market." }, "source": { "id": "src_aafb344bff238edf", "label": "DailyMed (NLM): current U.S. WEGOVY semaglutide injection and oral-tablet label", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=ee06186f-2aa3-4990-a760-757579d8f77b", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "已链接当前公开标签", "en": "Current public label linked" }, "detail": { "zh": "仅对应本页所列的美国公开标签；不据此推定库存、可售资格或其他市场状态。", "en": "Only the U.S. public label listed on this page is linked; no stock, sale-eligibility or other-market conclusion is inferred." } }, { "market": { "zh": "中国大陆、欧盟、日本", "en": "Mainland China, EU, Japan" }, "status": { "zh": "待逐项建立市场记录", "en": "Market record not established" }, "detail": { "zh": "不从美国公开标签推定当地批准、持有人、规格、供应或可售资格。", "en": "No local approval, holder, strength, supply or sale-eligibility conclusion is inferred from the U.S. public label." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "当前美国标签能代表其他国家或地区吗？", "en": "Does a current U.S. label represent another country or region?" }, "answer": { "zh": "不能。它是逐项阅读入口；品牌、剂型、规格、可得性和安全信息仍须以目标市场的现行官方文件核对。", "en": "No. It is an item-by-item reading entry point; brand, dosage form, strength, availability and safety information still require checking against the target market's current official document." } }, { "question": { "zh": "为什么这里不展示价格或原研/仿制结论？", "en": "Why are price and originator/generic conclusions not shown?" }, "answer": { "zh": "这些结论需要产品、剂型、规格、包装、市场、日期和原始记录分别齐全并经人工审核；单一标签文件不足以支持。", "en": "Those conclusions require separately complete and human-reviewed product, dosage-form, strength, pack, market, date and primary-record fields; one label file is insufficient." } } ], "relatedMedicineChecks": [ { "target": { "id": "ozempic", "brand": "Ozempic", "generic": "司美格鲁肽", "canonicalUrls": { "zh": "https://origindrug.com/drugs/ozempic/", "en": "https://origindrug.com/en/drugs/ozempic/" } }, "title": { "zh": "与 OZEMPIC／司美格鲁肽注射剂 同在药单上时：同含司美格鲁肽先做完整药单核对", "en": "When OZEMPIC / semaglutide injection is on the same list: products containing semaglutide need a complete medicine-list review" }, "summary": { "zh": "当前 DailyMed WEGOVY 美国公开标签的 Limitations of Use 提示：不建议将 WEGOVY 注射剂或片剂与其他含司美格鲁肽产品或其他 GLP-1 受体激动剂联用。这条来源限定的提示要求先把每个实际药盒、剂型、强度、处方、非处方药和补充剂交给药师或开方团队核对；它不判断个人能否同服，也不建议自行停用、错开时间、替换或调整任何一种药。", "en": "The current U.S. DailyMed WEGOVY public label states in Limitations of Use that concomitant use of WEGOVY injection or tablets with other semaglutide-containing products or any other GLP-1 receptor agonist is not recommended. This source-bounded cue means that every actual pack, dosage form, strength, prescription, OTC product and supplement should first be reviewed by a pharmacist or prescriber; it does not decide an individual's co-use or advise self-stopping, time-separation, replacement or adjustment of either medicine." }, "source": { "id": "src_aafb344bff238edf", "label": "DailyMed（NLM）：WEGOVY 当前美国公开标签（Limitations of Use：其他含司美格鲁肽产品／GLP-1 受体激动剂；SPL v19）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=ee06186f-2aa3-4990-a760-757579d8f77b", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "review_complete_medicine_list_no_self_directed_change" }, { "target": { "id": "rybelsus", "brand": "Rybelsus", "generic": "司美格鲁肽", "canonicalUrls": { "zh": "https://origindrug.com/drugs/rybelsus/", "en": "https://origindrug.com/en/drugs/rybelsus/" } }, "title": { "zh": "与 RYBELSUS／司美格鲁肽口服片 同在药单上时：同含司美格鲁肽先做完整药单核对", "en": "When RYBELSUS / oral semaglutide tablets is on the same list: products containing semaglutide need a complete medicine-list review" }, "summary": { "zh": "当前 DailyMed WEGOVY 美国公开标签的 Limitations of Use 提示：不建议将 WEGOVY 注射剂或片剂与其他含司美格鲁肽产品或其他 GLP-1 受体激动剂联用。这条来源限定的提示要求先把每个实际药盒、剂型、强度、处方、非处方药和补充剂交给药师或开方团队核对；它不判断个人能否同服，也不建议自行停用、错开时间、替换或调整任何一种药。", "en": "The current U.S. DailyMed WEGOVY public label states in Limitations of Use that concomitant use of WEGOVY injection or tablets with other semaglutide-containing products or any other GLP-1 receptor agonist is not recommended. This source-bounded cue means that every actual pack, dosage form, strength, prescription, OTC product and supplement should first be reviewed by a pharmacist or prescriber; it does not decide an individual's co-use or advise self-stopping, time-separation, replacement or adjustment of either medicine." }, "source": { "id": "src_aafb344bff238edf", "label": "DailyMed（NLM）：WEGOVY 当前美国公开标签（Limitations of Use：其他含司美格鲁肽产品／GLP-1 受体激动剂；SPL v19）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=ee06186f-2aa3-4990-a760-757579d8f77b", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "review_complete_medicine_list_no_self_directed_change" } ], "relatedArticleSlugs": [ "dosage-forms-are-part-of-medicine-identity", "medicine-label-for-everyday-questions", "how-to-read-a-drug-label" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/wegovy/", "en": "https://origindrug.com/en/drugs/wegovy/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "mounjaro", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-20", "status": "published_traceable_archive" }, "names": { "brand": "Mounjaro", "generic": "替尔泊肽", "aliases": [ "tirzepatide" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "代谢", "sourceArchiveMarket": "美国当前 MOUNJARO 替尔泊肽公开标签（DailyMed SPL v38，2026-05-06 发布；本版仅展示六个四支单剂量预充笔参考面板）", "dosageFormClass": "替尔泊肽皮下注射液：本版已核对 2.5、5、7.5、10、12.5、15 mg/0.5 mL 的四支单剂量预充笔美国标签面板；同标签其他容器/装置须分开核对", "dosageFormClassCode": "subcutaneous_injection", "route": "皮下注射", "routeCode": "subcutaneous", "historicalApprovalEntry": "2022（FDA 2026 标签所列美国初始批准）", "archiveSponsorText": "Eli Lilly and Company / DailyMed（NLM）当前美国公开标签" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-mounjaro-prefilled-pen-2-5mg-0-5ml-ndc-0002-1506-80", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v38（2026-05-06 发布）", "en": "DailyMed SPL v38 published 6 May 2026" }, "dosageForm": { "zh": "替尔泊肽单剂量预充式自动注射笔", "en": "tirzepatide single-dose prefilled autoinjector" }, "route": { "zh": "皮下", "en": "subcutaneous" }, "routeCodes": [ "subcutaneous" ], "productCode": "NDC 0002-1506-80", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_single_dose_prefilled_pen", "primaryDisplay": { "zh": "2.5 mg/0.5 mL／每支单剂量预充笔；4 支纸盒装", "en": "2.5 mg/0.5 mL per single-dose prefilled pen; carton of 4 pens" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=d2d7da5d-ad07-4228-955f-cf7e355c8cc0&name=moun-cart-2point5mg-066-01.jpg", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "替尔泊肽", "en": "tirzepatide" }, "value": 2.5, "unit": "mg", "basisCode": "per_single_dose_prefilled_pen", "basisLabel": { "zh": "每支单剂量预充笔的标签标示量；不是个人注射量", "en": "labelled amount in one single-dose prefilled pen; not an individual's injection amount" } } ], "concentration": null, "container": { "typeCode": "single_dose_prefilled_pen", "typeLabel": { "zh": "单剂量预充笔", "en": "single-dose prefilled pen" }, "fill": { "value": 0.5, "unit": "mL" }, "countPerPackage": 4, "countUnit": { "zh": "支/纸盒", "en": "pens per carton" } }, "deliveryDevice": { "typeCode": "prefilled_autoinjector", "name": { "zh": "单剂量预充式自动注射笔", "en": "single-dose prefilled autoinjector" } }, "compatibleReusableDevice": null, "listingStatus": null, "package": { "count": 4, "unit": { "zh": "支单剂量预充笔/纸盒", "en": "single-dose prefilled pens per carton" } }, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_f5158d6a3dd9af6e", "label": "DailyMed（NLM）：MOUNJARO 替尔泊肽当前美国公开标签（Eli Lilly；SPL v38，2026-05-06 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d2d7da5d-ad07-4228-955f-cf7e355c8cc0", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-mounjaro-prefilled-pen-5mg-0-5ml-ndc-0002-1495-80", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v38（2026-05-06 发布）", "en": "DailyMed SPL v38 published 6 May 2026" }, "dosageForm": { "zh": "替尔泊肽单剂量预充式自动注射笔", "en": "tirzepatide single-dose prefilled autoinjector" }, "route": { "zh": "皮下", "en": "subcutaneous" }, "routeCodes": [ "subcutaneous" ], "productCode": "NDC 0002-1495-80", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_single_dose_prefilled_pen", "primaryDisplay": { "zh": "5 mg/0.5 mL／每支单剂量预充笔；4 支纸盒装", "en": "5 mg/0.5 mL per single-dose prefilled pen; carton of 4 pens" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=d2d7da5d-ad07-4228-955f-cf7e355c8cc0&name=moun-cart-5mg-067-01.jpg", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "替尔泊肽", "en": "tirzepatide" }, "value": 5, "unit": "mg", "basisCode": "per_single_dose_prefilled_pen", "basisLabel": { "zh": "每支单剂量预充笔的标签标示量；不是个人注射量", "en": "labelled amount in one single-dose prefilled pen; not an individual's injection amount" } } ], "concentration": null, "container": { "typeCode": "single_dose_prefilled_pen", "typeLabel": { "zh": "单剂量预充笔", "en": "single-dose prefilled pen" }, "fill": { "value": 0.5, "unit": "mL" }, "countPerPackage": 4, "countUnit": { "zh": "支/纸盒", "en": "pens per carton" } }, "deliveryDevice": { "typeCode": "prefilled_autoinjector", "name": { "zh": "单剂量预充式自动注射笔", "en": "single-dose prefilled autoinjector" } }, "compatibleReusableDevice": null, "listingStatus": null, "package": { "count": 4, "unit": { "zh": "支单剂量预充笔/纸盒", "en": "single-dose prefilled pens per carton" } }, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_f5158d6a3dd9af6e", "label": "DailyMed（NLM）：MOUNJARO 替尔泊肽当前美国公开标签（Eli Lilly；SPL v38，2026-05-06 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d2d7da5d-ad07-4228-955f-cf7e355c8cc0", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-mounjaro-prefilled-pen-7-5mg-0-5ml-ndc-0002-1484-80", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v38（2026-05-06 发布）", "en": "DailyMed SPL v38 published 6 May 2026" }, "dosageForm": { "zh": "替尔泊肽单剂量预充式自动注射笔", "en": "tirzepatide single-dose prefilled autoinjector" }, "route": { "zh": "皮下", "en": "subcutaneous" }, "routeCodes": [ "subcutaneous" ], "productCode": "NDC 0002-1484-80", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_single_dose_prefilled_pen", "primaryDisplay": { "zh": "7.5 mg/0.5 mL／每支单剂量预充笔；4 支纸盒装", "en": "7.5 mg/0.5 mL per single-dose prefilled pen; carton of 4 pens" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=d2d7da5d-ad07-4228-955f-cf7e355c8cc0&name=moun-cart-7point5mg-068-01.jpg", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "替尔泊肽", "en": "tirzepatide" }, "value": 7.5, "unit": "mg", "basisCode": "per_single_dose_prefilled_pen", "basisLabel": { "zh": "每支单剂量预充笔的标签标示量；不是个人注射量", "en": "labelled amount in one single-dose prefilled pen; not an individual's injection amount" } } ], "concentration": null, "container": { "typeCode": "single_dose_prefilled_pen", "typeLabel": { "zh": "单剂量预充笔", "en": "single-dose prefilled pen" }, "fill": { "value": 0.5, "unit": "mL" }, "countPerPackage": 4, "countUnit": { "zh": "支/纸盒", "en": "pens per carton" } }, "deliveryDevice": { "typeCode": "prefilled_autoinjector", "name": { "zh": "单剂量预充式自动注射笔", "en": "single-dose prefilled autoinjector" } }, "compatibleReusableDevice": null, "listingStatus": null, "package": { "count": 4, "unit": { "zh": "支单剂量预充笔/纸盒", "en": "single-dose prefilled pens per carton" } }, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_f5158d6a3dd9af6e", "label": "DailyMed（NLM）：MOUNJARO 替尔泊肽当前美国公开标签（Eli Lilly；SPL v38，2026-05-06 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d2d7da5d-ad07-4228-955f-cf7e355c8cc0", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-mounjaro-prefilled-pen-10mg-0-5ml-ndc-0002-1471-80", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v38（2026-05-06 发布）", "en": "DailyMed SPL v38 published 6 May 2026" }, "dosageForm": { "zh": "替尔泊肽单剂量预充式自动注射笔", "en": "tirzepatide single-dose prefilled autoinjector" }, "route": { "zh": "皮下", "en": "subcutaneous" }, "routeCodes": [ "subcutaneous" ], "productCode": "NDC 0002-1471-80", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_single_dose_prefilled_pen", "primaryDisplay": { "zh": "10 mg/0.5 mL／每支单剂量预充笔；4 支纸盒装", "en": "10 mg/0.5 mL per single-dose prefilled pen; carton of 4 pens" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=d2d7da5d-ad07-4228-955f-cf7e355c8cc0&name=moun-cart-10mg-069-01.jpg", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "替尔泊肽", "en": "tirzepatide" }, "value": 10, "unit": "mg", "basisCode": "per_single_dose_prefilled_pen", "basisLabel": { "zh": "每支单剂量预充笔的标签标示量；不是个人注射量", "en": "labelled amount in one single-dose prefilled pen; not an individual's injection amount" } } ], "concentration": null, "container": { "typeCode": "single_dose_prefilled_pen", "typeLabel": { "zh": "单剂量预充笔", "en": "single-dose prefilled pen" }, "fill": { "value": 0.5, "unit": "mL" }, "countPerPackage": 4, "countUnit": { "zh": "支/纸盒", "en": "pens per carton" } }, "deliveryDevice": { "typeCode": "prefilled_autoinjector", "name": { "zh": "单剂量预充式自动注射笔", "en": "single-dose prefilled autoinjector" } }, "compatibleReusableDevice": null, "listingStatus": null, "package": { "count": 4, "unit": { "zh": "支单剂量预充笔/纸盒", "en": "single-dose prefilled pens per carton" } }, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_f5158d6a3dd9af6e", "label": "DailyMed（NLM）：MOUNJARO 替尔泊肽当前美国公开标签（Eli Lilly；SPL v38，2026-05-06 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d2d7da5d-ad07-4228-955f-cf7e355c8cc0", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-mounjaro-prefilled-pen-12-5mg-0-5ml-ndc-0002-1460-80", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v38（2026-05-06 发布）", "en": "DailyMed SPL v38 published 6 May 2026" }, "dosageForm": { "zh": "替尔泊肽单剂量预充式自动注射笔", "en": "tirzepatide single-dose prefilled autoinjector" }, "route": { "zh": "皮下", "en": "subcutaneous" }, "routeCodes": [ "subcutaneous" ], "productCode": "NDC 0002-1460-80", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_single_dose_prefilled_pen", "primaryDisplay": { "zh": "12.5 mg/0.5 mL／每支单剂量预充笔；4 支纸盒装", "en": "12.5 mg/0.5 mL per single-dose prefilled pen; carton of 4 pens" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=d2d7da5d-ad07-4228-955f-cf7e355c8cc0&name=moun-cart-12point5mg-070-01.jpg", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "替尔泊肽", "en": "tirzepatide" }, "value": 12.5, "unit": "mg", "basisCode": "per_single_dose_prefilled_pen", "basisLabel": { "zh": "每支单剂量预充笔的标签标示量；不是个人注射量", "en": "labelled amount in one single-dose prefilled pen; not an individual's injection amount" } } ], "concentration": null, "container": { "typeCode": "single_dose_prefilled_pen", "typeLabel": { "zh": "单剂量预充笔", "en": "single-dose prefilled pen" }, "fill": { "value": 0.5, "unit": "mL" }, "countPerPackage": 4, "countUnit": { "zh": "支/纸盒", "en": "pens per carton" } }, "deliveryDevice": { "typeCode": "prefilled_autoinjector", "name": { "zh": "单剂量预充式自动注射笔", "en": "single-dose prefilled autoinjector" } }, "compatibleReusableDevice": null, "listingStatus": null, "package": { "count": 4, "unit": { "zh": "支单剂量预充笔/纸盒", "en": "single-dose prefilled pens per carton" } }, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_f5158d6a3dd9af6e", "label": "DailyMed（NLM）：MOUNJARO 替尔泊肽当前美国公开标签（Eli Lilly；SPL v38，2026-05-06 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d2d7da5d-ad07-4228-955f-cf7e355c8cc0", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-mounjaro-prefilled-pen-15mg-0-5ml-ndc-0002-1457-80", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v38（2026-05-06 发布）", "en": "DailyMed SPL v38 published 6 May 2026" }, "dosageForm": { "zh": "替尔泊肽单剂量预充式自动注射笔", "en": "tirzepatide single-dose prefilled autoinjector" }, "route": { "zh": "皮下", "en": "subcutaneous" }, "routeCodes": [ "subcutaneous" ], "productCode": "NDC 0002-1457-80", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_single_dose_prefilled_pen", "primaryDisplay": { "zh": "15 mg/0.5 mL／每支单剂量预充笔；4 支纸盒装", "en": "15 mg/0.5 mL per single-dose prefilled pen; carton of 4 pens" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=d2d7da5d-ad07-4228-955f-cf7e355c8cc0&name=moun-cart-15mg-071-01.jpg", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "替尔泊肽", "en": "tirzepatide" }, "value": 15, "unit": "mg", "basisCode": "per_single_dose_prefilled_pen", "basisLabel": { "zh": "每支单剂量预充笔的标签标示量；不是个人注射量", "en": "labelled amount in one single-dose prefilled pen; not an individual's injection amount" } } ], "concentration": null, "container": { "typeCode": "single_dose_prefilled_pen", "typeLabel": { "zh": "单剂量预充笔", "en": "single-dose prefilled pen" }, "fill": { "value": 0.5, "unit": "mL" }, "countPerPackage": 4, "countUnit": { "zh": "支/纸盒", "en": "pens per carton" } }, "deliveryDevice": { "typeCode": "prefilled_autoinjector", "name": { "zh": "单剂量预充式自动注射笔", "en": "single-dose prefilled autoinjector" } }, "compatibleReusableDevice": null, "listingStatus": null, "package": { "count": 4, "unit": { "zh": "支单剂量预充笔/纸盒", "en": "single-dose prefilled pens per carton" } }, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_f5158d6a3dd9af6e", "label": "DailyMed（NLM）：MOUNJARO 替尔泊肽当前美国公开标签（Eli Lilly；SPL v38，2026-05-06 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d2d7da5d-ad07-4228-955f-cf7e355c8cc0", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-mounjaro-prefilled-pen-2-5mg-0-5ml-ndc-0002-1506-80", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=d2d7da5d-ad07-4228-955f-cf7e355c8cc0&name=moun-cart-2point5mg-066-01.jpg", "alt": "MOUNJARO 2.5 mg/0.5 mL 在美国 DailyMed 公开标签中的四支单剂量预充笔包装图", "archiveMarket": "美国", "labelVersion": "DailyMed SPL v38（2026-05-06 发布）", "presentation": "MOUNJARO 2.5 mg/0.5 mL、NDC 0002-1506-80、4 支单剂量预充笔纸盒面板（当前美国标签所列）。", "notice": "此图只对应 MOUNJARO、2.5 mg/0.5 mL、NDC 0002-1506-80 与 4 支单剂量预充笔纸盒；不用于鉴定真伪，也不代表其他强度、KwikPen、单剂量瓶、多剂量瓶、其他包装、其他市场、当前可得性或任何个人用药方案。", "source": { "id": "src_f5158d6a3dd9af6e", "label": "DailyMed（NLM）：MOUNJARO 替尔泊肽当前美国公开标签（Eli Lilly；SPL v38，2026-05-06 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d2d7da5d-ad07-4228-955f-cf7e355c8cc0", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "MOUNJARO 说明书放大阅读：单剂量预充笔与其他容器/装置必须分开核对", "en": "MOUNJARO label reading: single-dose prefilled pens must be separated from other containers and devices" }, "summary": { "zh": "本模块以 Eli Lilly 的当前美国 DailyMed 标签为阅读入口，展示六个已逐项核对的四支单剂量预充笔包装面板。它帮助核对准确产品身份，不提供个人注射量、频率、补用、转换或替换方案。", "en": "This module uses Eli Lilly's current U.S. DailyMed label as a reading entry point and shows six individually checked four-single-dose-prefilled-pen panels. It helps check exact product identity; it does not provide an individual's injection amount, frequency, make-up, conversion or substitution plan." }, "checks": [ { "zh": "先把 MOUNJARO、替尔泊肽、mg/0.5 mL、NDC、单剂量预充笔和四支纸盒一起核对。包装上的 mg/0.5 mL 是一支所列装置内的标签量与液体体积，不是个人该使用多少的答案。", "en": "Check MOUNJARO, tirzepatide, mg/0.5 mL, NDC, single-dose prefilled pen and carton of four together. The mg/0.5 mL on a pack is the labelled amount and liquid volume in the stated device, not an answer to how much an individual should use." }, { "zh": "同一当前标签还列有 KwikPen、单剂量瓶和多剂量瓶。即使品牌或总毫克数相同，也不能只凭名称、图片或数字把它们视作这些预充笔，或自行转换、叠加、改频率。", "en": "The same current label also lists KwikPen, single-dose vial and multi-dose vial presentations. Even with the same brand or total milligrams, a name, photo or number alone does not make them these prefilled pens or support self-conversion, combination or frequency changes." }, { "zh": "包装、装置和强度文字是身份线索，不是注射日程、补用、拆分或与其他 GLP-1 类产品联用的规则。任何换装置、换强度或不确定实际产品的问题，都应带上实际包装和完整药单请药师或开方团队核对。", "en": "Package, device and strength wording are identity clues, not rules for an injection schedule, make-up, splitting or combination with another GLP-1 product. For any device or strength change, or uncertainty about the product in hand, bring the actual pack and complete medicine list to a pharmacist or prescribing team." }, { "zh": "若出现持续呕吐、明显脱水、严重腹痛、低血糖样症状或其他急性不适，应及时使用当地医疗渠道；网页和包装图不能替代紧急判断。", "en": "For persistent vomiting, marked dehydration, severe abdominal pain, low-glucose-like symptoms or another acute illness, promptly use local medical care; a webpage and package image cannot replace urgent judgement." } ], "source": { "id": "src_f5158d6a3dd9af6e", "label": "DailyMed（NLM）：MOUNJARO 替尔泊肽当前美国公开标签（Eli Lilly；SPL v38，2026-05-06 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d2d7da5d-ad07-4228-955f-cf7e355c8cc0", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "替尔泊肽怎样起作用：它作用于 GIP 与 GLP-1 受体", "en": "How tirzepatide works: it acts at GIP and GLP-1 receptors" }, "summary": { "zh": "FDA 标签将替尔泊肽描述为 GIP 和 GLP-1 受体激动剂。标签说明这两条通路与葡萄糖依赖性胰岛素分泌及胰高血糖素分泌等作用有关；这不是对任何个人疗效、剂量、递增方案或是否可与其他产品同用的结论。", "en": "The FDA label describes tirzepatide as a GIP and GLP-1 receptor agonist. It links these pathways to actions including glucose-dependent insulin secretion and glucagon secretion; this is not a conclusion about individual benefit, dose, escalation or whether it can be used with another product." }, "checks": [ { "zh": "双受体机制不使其与任何 GLP-1 产品可自行合用、切换或按总毫克数换算。每件产品的装置、强度、用途、目标市场和完整药单都需要专业人员核对。", "en": "A dual-receptor mechanism does not make it self-combinable or switchable with any GLP-1 product, or convertible by total milligrams. Each product’s device, strength, use context, target market and complete medicine list need professional review." }, { "zh": "机制文字无法预判个人血糖、食欲、胃肠道反应或低血糖风险。正在使用其他降糖药时，更不能从机制页面自行改变任何一件产品。", "en": "Mechanism language cannot predict an individual’s glucose, appetite, gastrointestinal response or low-glucose risk. When other glucose-lowering medicines are used, it is even less a basis for self-changing any product." }, { "zh": "装置上的剂量与浓度是产品身份的一部分；它们不从机制中导出“补一针”“两支合并”或“减半”的做法。任何此类问题必须回到现行标签、处方和专业支持。", "en": "A device’s dose and concentration are part of product identity; the mechanism does not derive practices such as “an extra injection,” “combine two devices” or “take half.” Such questions must return to the current label, prescription and professional support." } ], "source": { "id": "src_365594d76bf477db", "label": "FDA：MOUNJARO 2026 美国处方信息（临床药理）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/215866s009lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "Mounjaro", "generic": "替尔泊肽", "dosageFormClass": "替尔泊肽皮下注射液：本版已核对 2.5、5、7.5、10、12.5、15 mg/0.5 mL 的四支单剂量预充笔美国标签面板；同标签其他容器/装置须分开核对" }, "labelSource": { "id": "src_f5158d6a3dd9af6e", "label": "DailyMed（NLM）：MOUNJARO 替尔泊肽当前美国公开标签（Eli Lilly；SPL v38，2026-05-06 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d2d7da5d-ad07-4228-955f-cf7e355c8cc0", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "productRoutes": [ { "source": { "id": "src_f5158d6a3dd9af6e", "label": "DailyMed（NLM）：MOUNJARO 替尔泊肽当前美国公开标签（Eli Lilly；SPL v38，2026-05-06 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d2d7da5d-ad07-4228-955f-cf7e355c8cc0", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_365594d76bf477db", "label": "FDA：MOUNJARO 2026 美国标签（NDA 215866）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/215866s009lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "当前美国 DailyMed 标签列出 MOUNJARO（tirzepatide）的多种容器和装置。本页已逐项核对其中六个“四支单剂量预充笔”纸盒面板：2.5、5、7.5、10、12.5、15 mg/0.5 mL。它只帮助核对准确品牌、通用名、标签量、NDC、容器、装置与来源；不据此推定其他容器、其他市场、供应、可售资格或个人使用方案。", "history": "同一 MOUNJARO 标签内的单剂量预充笔、KwikPen、单剂量瓶和多剂量瓶是不同产品呈现。商品名、通用名、总毫克数或照片相同，都不能使它们成为可自行替代、换算、叠加或调整频率的同一产品。", "sourceDocuments": [ { "id": "src_365594d76bf477db", "label": "FDA：MOUNJARO 2026 美国标签（NDA 215866）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/215866s009lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_f5158d6a3dd9af6e", "label": "DailyMed（NLM）：MOUNJARO 替尔泊肽当前美国公开标签（Eli Lilly；SPL v38，2026-05-06 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d2d7da5d-ad07-4228-955f-cf7e355c8cc0", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_5ed30b676fbb9773", "label": "FDA Drugs@FDA 官方检索入口", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_lookup_entry", "documentKind": "regulatory_lookup", "market": "US", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } ], "applicationNumber": "NDA 215866", "approvalTimeline": [ { "date": "2022", "title": { "zh": "FDA 标签所列美国初始批准年份", "en": "Initial U.S. approval year listed in the FDA label" }, "detail": { "zh": "本页链接的 FDA 标签档案列示 Initial U.S. Approval: 2022。该历史定位不等同于当前批准、可得性、持有人或其他市场状态。", "en": "The FDA label archive linked here lists Initial U.S. Approval: 2022. This historical locator is not a conclusion about current approval, availability, holder or another market." }, "source": { "id": "src_365594d76bf477db", "label": "FDA: MOUNJARO label archive", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/215866s009lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, { "date": "2026", "title": { "zh": "FDA 标签档案版本", "en": "FDA label archive version" }, "detail": { "zh": "本页链接 2026 的 FDA 标签档案作为可复核阅读入口。现行标签、规格、适应症和安全信息必须另行以目标市场当前文件核对。", "en": "This page links the 2026 FDA label archive as a traceable reading entry point. Current labeling, strength, indication and safety information require separate verification against the target market’s current document." }, "source": { "id": "src_365594d76bf477db", "label": "FDA: MOUNJARO label archive", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/215866s009lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "已链接公开标签档案", "en": "Public label archive linked" }, "detail": { "zh": "仅对应本页所列 FDA 文件。", "en": "Only the FDA document listed on this page is linked." } }, { "market": { "zh": "中国大陆、欧盟、日本", "en": "Mainland China, EU, Japan" }, "status": { "zh": "待逐项建立市场记录", "en": "Market record not established" }, "detail": { "zh": "不从美国标签档案推定当地批准、持有人、规格、供应或可售资格。", "en": "No local approval, holder, strength, supply or sale-eligibility conclusion is inferred from the U.S. label archive." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "标签档案能代表现在的产品信息吗？", "en": "Does a label archive represent current product information?" }, "answer": { "zh": "不能自动代表。档案用于定位来源；需要以目标市场的现行官方标签逐项复核。", "en": "Not automatically. The archive locates a source; each point needs verification against the target market’s current official label." } }, { "question": { "zh": "为什么这里不展示价格或原研/仿制结论？", "en": "Why are price and originator/generic conclusions not shown?" }, "answer": { "zh": "这些结论需要产品、剂型、规格、包装、市场、日期和原始记录分别齐全并经人工审核；单一标签文件不足以支持。", "en": "Those conclusions require separately complete and human-reviewed product, dosage-form, strength, pack, market, date and primary-record fields; one label file is insufficient." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "dosage-forms-are-part-of-medicine-identity", "medicine-label-for-everyday-questions", "how-to-read-a-drug-label" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/mounjaro/", "en": "https://origindrug.com/en/drugs/mounjaro/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "trulicity", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-16", "status": "published_traceable_archive" }, "names": { "brand": "Trulicity", "generic": "度拉糖肽", "aliases": [ "dulaglutide" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "代谢", "sourceArchiveMarket": "美国公开监管档案", "dosageFormClass": "皮下注射液（单剂量预充笔；FDA 2025 标签所列）", "dosageFormClassCode": "subcutaneous_injection", "route": "皮下注射", "routeCode": "subcutaneous", "historicalApprovalEntry": "2014（FDA 2025 标签所列美国初始批准）", "archiveSponsorText": "FDA 公开监管档案" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-trulicity-dulaglutide-0-75mg-0-5ml-single-dose-pen-0002143380", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v62（2026-08-10 发布）", "en": "DailyMed SPL v62 (published 10 Aug 2026)" }, "dosageForm": { "zh": "TRULICITY 度拉糖肽单剂量预充注射笔", "en": "TRULICITY dulaglutide single-dose prefilled pen" }, "route": { "zh": "皮下注射（标签产品身份字段）", "en": "subcutaneous injection (label product-identity field)" }, "routeCodes": [ "subcutaneous_injection" ], "productCode": "NDC 0002-1433-80", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_single_dose_prefilled_pen", "primaryDisplay": { "zh": "每支单剂量预充笔含度拉糖肽 0.75 mg/0.5 mL；每盒 4 支", "en": "Dulaglutide 0.75 mg/0.5 mL per single-dose prefilled pen; 4 pens per carton" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=us-trulicity-sup-point75mg-004-05.jpg&setid=463050bd-2b1c-40f5-b3c3-0a04bb433309&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "度拉糖肽", "en": "dulaglutide" }, "value": 0.75, "unit": "mg", "basisCode": "per_single_dose_prefilled_pen", "basisLabel": { "zh": "每支单剂量预充笔的标签含量；不是个人起始、加量或频次指令", "en": "labelled content per single-dose prefilled pen; not an individual starting, escalation or frequency instruction" } } ], "concentration": null, "container": { "typeCode": "single_dose_prefilled_pen", "typeLabel": { "zh": "0.5 mL 单剂量预充注射笔", "en": "0.5 mL single-dose prefilled pen" }, "fill": { "value": 0.5, "unit": "mL" }, "countPerPackage": null, "countUnit": null }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-28", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 4, "unit": { "zh": "支单剂量预充笔/盒", "en": "single-dose prefilled pens per carton" } }, "physicalClues": { "color": null, "shape": { "zh": "单剂量预充注射笔与四支装纸盒", "en": "single-dose prefilled pen and four-pen carton" }, "imprint": null, "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_d95ee204b2281838", "label": "DailyMed（NLM）：TRULICITY 当前美国公开标签（Eli Lilly；SPL v62）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=463050bd-2b1c-40f5-b3c3-0a04bb433309", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-trulicity-dulaglutide-1-5mg-0-5ml-single-dose-pen-0002143480", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v62（2026-08-10 发布）", "en": "DailyMed SPL v62 (published 10 Aug 2026)" }, "dosageForm": { "zh": "TRULICITY 度拉糖肽单剂量预充注射笔", "en": "TRULICITY dulaglutide single-dose prefilled pen" }, "route": { "zh": "皮下注射（标签产品身份字段）", "en": "subcutaneous injection (label product-identity field)" }, "routeCodes": [ "subcutaneous_injection" ], "productCode": "NDC 0002-1434-80", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_single_dose_prefilled_pen", "primaryDisplay": { "zh": "每支单剂量预充笔含度拉糖肽 1.5 mg/0.5 mL；每盒 4 支", "en": "Dulaglutide 1.5 mg/0.5 mL per single-dose prefilled pen; 4 pens per carton" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=us-trulicity-sup-1point5mg-005-05.jpg&setid=463050bd-2b1c-40f5-b3c3-0a04bb433309&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "度拉糖肽", "en": "dulaglutide" }, "value": 1.5, "unit": "mg", "basisCode": "per_single_dose_prefilled_pen", "basisLabel": { "zh": "每支单剂量预充笔的标签含量；不是个人起始、加量或频次指令", "en": "labelled content per single-dose prefilled pen; not an individual starting, escalation or frequency instruction" } } ], "concentration": null, "container": { "typeCode": "single_dose_prefilled_pen", "typeLabel": { "zh": "0.5 mL 单剂量预充注射笔", "en": "0.5 mL single-dose prefilled pen" }, "fill": { "value": 0.5, "unit": "mL" }, "countPerPackage": null, "countUnit": null }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-28", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 4, "unit": { "zh": "支单剂量预充笔/盒", "en": "single-dose prefilled pens per carton" } }, "physicalClues": { "color": null, "shape": { "zh": "单剂量预充注射笔与四支装纸盒", "en": "single-dose prefilled pen and four-pen carton" }, "imprint": null, "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_d95ee204b2281838", "label": "DailyMed（NLM）：TRULICITY 当前美国公开标签（Eli Lilly；SPL v62）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=463050bd-2b1c-40f5-b3c3-0a04bb433309", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-trulicity-dulaglutide-3mg-0-5ml-single-dose-pen-0002223680", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v62（2026-08-10 发布）", "en": "DailyMed SPL v62 (published 10 Aug 2026)" }, "dosageForm": { "zh": "TRULICITY 度拉糖肽单剂量预充注射笔", "en": "TRULICITY dulaglutide single-dose prefilled pen" }, "route": { "zh": "皮下注射（标签产品身份字段）", "en": "subcutaneous injection (label product-identity field)" }, "routeCodes": [ "subcutaneous_injection" ], "productCode": "NDC 0002-2236-80", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_single_dose_prefilled_pen", "primaryDisplay": { "zh": "每支单剂量预充笔含度拉糖肽 3 mg/0.5 mL；每盒 4 支", "en": "Dulaglutide 3 mg/0.5 mL per single-dose prefilled pen; 4 pens per carton" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=us-trulicity-sup-3mg-055-02.jpg&setid=463050bd-2b1c-40f5-b3c3-0a04bb433309&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "度拉糖肽", "en": "dulaglutide" }, "value": 3, "unit": "mg", "basisCode": "per_single_dose_prefilled_pen", "basisLabel": { "zh": "每支单剂量预充笔的标签含量；不是个人起始、加量或频次指令", "en": "labelled content per single-dose prefilled pen; not an individual starting, escalation or frequency instruction" } } ], "concentration": null, "container": { "typeCode": "single_dose_prefilled_pen", "typeLabel": { "zh": "0.5 mL 单剂量预充注射笔", "en": "0.5 mL single-dose prefilled pen" }, "fill": { "value": 0.5, "unit": "mL" }, "countPerPackage": null, "countUnit": null }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-28", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 4, "unit": { "zh": "支单剂量预充笔/盒", "en": "single-dose prefilled pens per carton" } }, "physicalClues": { "color": null, "shape": { "zh": "单剂量预充注射笔与四支装纸盒", "en": "single-dose prefilled pen and four-pen carton" }, "imprint": null, "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_d95ee204b2281838", "label": "DailyMed（NLM）：TRULICITY 当前美国公开标签（Eli Lilly；SPL v62）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=463050bd-2b1c-40f5-b3c3-0a04bb433309", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-trulicity-dulaglutide-4-5mg-0-5ml-single-dose-pen-0002318280", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v62（2026-08-10 发布）", "en": "DailyMed SPL v62 (published 10 Aug 2026)" }, "dosageForm": { "zh": "TRULICITY 度拉糖肽单剂量预充注射笔", "en": "TRULICITY dulaglutide single-dose prefilled pen" }, "route": { "zh": "皮下注射（标签产品身份字段）", "en": "subcutaneous injection (label product-identity field)" }, "routeCodes": [ "subcutaneous_injection" ], "productCode": "NDC 0002-3182-80", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_single_dose_prefilled_pen", "primaryDisplay": { "zh": "每支单剂量预充笔含度拉糖肽 4.5 mg/0.5 mL；每盒 4 支", "en": "Dulaglutide 4.5 mg/0.5 mL per single-dose prefilled pen; 4 pens per carton" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=us-trulicity-sup-4point5mg-056-02.jpg&setid=463050bd-2b1c-40f5-b3c3-0a04bb433309&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "度拉糖肽", "en": "dulaglutide" }, "value": 4.5, "unit": "mg", "basisCode": "per_single_dose_prefilled_pen", "basisLabel": { "zh": "每支单剂量预充笔的标签含量；不是个人起始、加量或频次指令", "en": "labelled content per single-dose prefilled pen; not an individual starting, escalation or frequency instruction" } } ], "concentration": null, "container": { "typeCode": "single_dose_prefilled_pen", "typeLabel": { "zh": "0.5 mL 单剂量预充注射笔", "en": "0.5 mL single-dose prefilled pen" }, "fill": { "value": 0.5, "unit": "mL" }, "countPerPackage": null, "countUnit": null }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-28", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 4, "unit": { "zh": "支单剂量预充笔/盒", "en": "single-dose prefilled pens per carton" } }, "physicalClues": { "color": null, "shape": { "zh": "单剂量预充注射笔与四支装纸盒", "en": "single-dose prefilled pen and four-pen carton" }, "imprint": null, "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_d95ee204b2281838", "label": "DailyMed（NLM）：TRULICITY 当前美国公开标签（Eli Lilly；SPL v62）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=463050bd-2b1c-40f5-b3c3-0a04bb433309", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": null, "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=us-trulicity-sup-1point5mg-005-05.jpg&setid=463050bd-2b1c-40f5-b3c3-0a04bb433309&type=img", "alt": "TRULICITY 1.5 mg/0.5 mL 单剂量预充笔在美国 DailyMed 公开标签中的四支装纸盒展开图", "archiveMarket": "美国", "labelVersion": "2026-06", "presentation": "TRULICITY 1.5 mg/0.5 mL、4 支单剂量预充笔纸盒展开图（DailyMed 页面所列 2026-06 更新标签）。", "notice": "此为美国 DailyMed 公开标签中明确对应 TRULICITY 1.5 mg/0.5 mL 四支单剂量预充笔的纸盒文字图，只帮助核对品牌、通用名、标示强度、给药途径、装置和来源；不用于鉴定真伪，也不证明其他强度、其他市场标签、当前包装、目标市场批准或可售资格。", "source": { "id": "src_d95ee204b2281838", "label": "DailyMed（NLM）：TRULICITY 公开标签（2026-06 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=463050bd-2b1c-40f5-b3c3-0a04bb433309", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "TRULICITY 说明书放大阅读：mg/0.5 mL 是装置强度，不是个人注射指令", "en": "TRULICITY label reading: mg/0.5 mL identifies device strength, not an individual injection instruction" }, "summary": { "zh": "本模块以 FDA 2025 美国标签为阅读入口，帮助区分 TRULICITY 单剂量预充笔的名称、强度和注射途径；它不提供个人起始、加量、漏用补用或与其他注射药转换的方案。", "en": "This module uses the 2025 U.S. FDA label as a reading entry point. It helps distinguish a TRULICITY single-dose pen's name, strength and injection route; it does not provide an individual starting, escalation, missed-dose or switching plan." }, "checks": [ { "zh": "该标签列出 0.75、1.5、3、4.5 mg/0.5 mL 单剂量预充笔。每个数字首先描述该准确装置中标示的药物量与液体体积；不能据此自行把两支、不同强度或另一种注射产品相加、拆分或互换。", "en": "The label lists 0.75, 1.5, 3 and 4.5 mg/0.5 mL single-dose pens. Each number first describes the stated medicine amount and liquid volume in that exact device; it does not permit self-combining, splitting or exchanging pens, strengths or another injectable product." }, { "zh": "该标签把与胰岛素或促胰岛素分泌药联用时的低血糖风险列为需要专业人员核对的情形。手中同时有多支“降糖针”或口服降糖药时，应带完整药单和实际包装请药师/开方团队核对，不要只按名称或频次自行叠加。", "en": "The label identifies hypoglycaemia risk with insulin or insulin secretagogues as a situation for professional review. When several glucose-lowering injections or oral medicines are present, bring the complete list and actual packages for pharmacist or prescriber review rather than self-combining from names or frequency alone." }, { "zh": "标签说明 TRULICITY 与胰岛素应为分开注射，不能混在同一注射中。它不等于所有人都应联用，也不说明任何人该怎样调整胰岛素；实际安排须以处方和专业指导为准。", "en": "The label states that TRULICITY and insulin are separate injections and must not be mixed in the same injection. That does not mean everyone should combine them or determine an insulin adjustment; the actual plan requires the prescription and professional guidance." }, { "zh": "图片、颜色、笔型和包装数字只能用于定位来源。不同市场、标签版本和产品包装可能不同；它们不能鉴定真伪、确认当前市场批准或替代出现不适、急性疾病或操作前后的医疗指示。", "en": "Images, colours, pen design and package numbers only help locate a source. Markets, label versions and packages can differ; they cannot authenticate a product, establish current market approval or replace medical instructions during symptoms, acute illness or procedures." } ], "source": { "id": "src_198d9ae73f3553a3", "label": "FDA：TRULICITY 2025-05 处方信息（BLA 125469）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/125469s063lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "度拉糖肽怎样起作用：它激活 GLP-1 受体，作用受血糖状态影响", "en": "How dulaglutide works: it activates the GLP-1 receptor, with actions related to glucose state" }, "summary": { "zh": "DailyMed 的 TRULICITY 公开标签描述：度拉糖肽激活胰腺 β 细胞上的 GLP-1 受体，增加细胞内 cAMP，继而促进葡萄糖依赖的胰岛素释放；同时减少胰高血糖素分泌并延缓胃排空。这解释药物作用路径，不等于能从一次血糖、体重、食欲或注射笔数字推导个人该怎样使用。", "en": "The public DailyMed TRULICITY label describes dulaglutide as activating the GLP-1 receptor on pancreatic beta cells, increasing intracellular cAMP and leading to glucose-dependent insulin release; it also decreases glucagon secretion and delays gastric emptying. This explains a drug-action pathway, not how an individual should use it based on one glucose result, body weight, appetite or a pen number." }, "checks": [ { "zh": "“葡萄糖依赖”是标签对药理作用的描述，并不把低血糖、联用或个人风险自动排除。与胰岛素、促胰岛素分泌药或其他降糖药一起使用时，完整药单和具体处方仍须由药师或开方团队核对。", "en": "“Glucose-dependent” describes pharmacology in the label; it does not automatically rule out hypoglycaemia, combination issues or individual risk. When insulin, an insulin secretagogue or other glucose-lowering medicines are also used, the complete list and exact prescription still need pharmacist or prescriber review." }, { "zh": "“延缓胃排空”能帮助理解为什么不能仅按包装或网络摘要自行安排同服的口服药。它不提供服药间隔、漏用后的补救、手术前后安排或胃肠道症状的个人处理方案。", "en": "“Delays gastric emptying” helps explain why oral co-medications cannot be scheduled from a package or web summary alone. It does not supply an individual spacing schedule, missed-use remedy, peri-procedural plan or response to gastrointestinal symptoms." }, { "zh": "0.75、1.5、3、4.5 mg/0.5 mL 描述的是不同标示强度的单剂量装置；药理机制相同不代表两支、两种强度或另一种 GLP-1 注射药可以自行相加、拆分、轮换或替代。", "en": "0.75, 1.5, 3 and 4.5 mg/0.5 mL describe single-dose devices with different stated strengths; shared pharmacology does not make two pens, two strengths or another GLP-1 injection self-combinable, splittable, alternable or substitutable." } ], "source": { "id": "src_d95ee204b2281838", "label": "DailyMed（NLM）：TRULICITY 公开标签（2026-06，临床药理）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=463050bd-2b1c-40f5-b3c3-0a04bb433309", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "Trulicity", "generic": "度拉糖肽", "dosageFormClass": "皮下注射液（单剂量预充笔；FDA 2025 标签所列）" }, "labelSource": { "id": "src_198d9ae73f3553a3", "label": "FDA：TRULICITY 2025-05 美国标签（BLA 125469）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/125469s063lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "productRoutes": [ { "source": { "id": "src_198d9ae73f3553a3", "label": "FDA：TRULICITY 2025-05 美国标签（BLA 125469）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/125469s063lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_d95ee204b2281838", "label": "DailyMed（NLM）：TRULICITY 公开标签（2026-06 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=463050bd-2b1c-40f5-b3c3-0a04bb433309", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "FDA 的 TRULICITY（dulaglutide）2025 美国标签列示其为皮下注射用制剂，并列出美国初始批准年份为 2014。页面提供可复核的美国监管资料入口；不据此推定其他市场的当前批准、规格、持有人、原研关系、供应或可售资格。", "history": "注射笔上的商品名、通用名、标示强度、液体体积和目标市场必须同时核对。标签中的规格或给药频次描述不能转换为个人开始、加量、漏用补用、与其他降糖药联用或换药方案。", "sourceDocuments": [ { "id": "src_198d9ae73f3553a3", "label": "FDA：TRULICITY 2025-05 美国标签（BLA 125469）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/125469s063lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_d95ee204b2281838", "label": "DailyMed（NLM）：TRULICITY 公开标签（2026-06 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=463050bd-2b1c-40f5-b3c3-0a04bb433309", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_5ed30b676fbb9773", "label": "FDA Drugs@FDA 官方检索入口", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_lookup_entry", "documentKind": "regulatory_lookup", "market": "US", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } ], "applicationNumber": "BLA 125469", "approvalTimeline": [ { "date": "2014", "title": { "zh": "FDA 标签所列美国初始批准年份", "en": "Initial U.S. approval year listed in the FDA label" }, "detail": { "zh": "本页链接的 FDA 标签档案列示 Initial U.S. Approval: 2014。该历史定位不等同于当前批准、可得性、持有人或其他市场状态。", "en": "The FDA label archive linked here lists Initial U.S. Approval: 2014. This historical locator is not a conclusion about current approval, availability, holder or another market." }, "source": { "id": "src_198d9ae73f3553a3", "label": "FDA: TRULICITY prescribing information", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/125469s063lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, { "date": "2025-05", "title": { "zh": "FDA 标签档案版本", "en": "FDA label archive version" }, "detail": { "zh": "本页链接 2025-05 的 FDA 标签档案作为可复核阅读入口。现行标签、规格、适应症和安全信息必须另行以目标市场当前文件核对。", "en": "This page links the 2025-05 FDA label archive as a traceable reading entry point. Current labeling, strength, indication and safety information require separate verification against the target market’s current document." }, "source": { "id": "src_198d9ae73f3553a3", "label": "FDA: TRULICITY prescribing information", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/125469s063lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "已链接公开标签档案", "en": "Public label archive linked" }, "detail": { "zh": "仅对应本页所列 FDA 文件。", "en": "Only the FDA document listed on this page is linked." } }, { "market": { "zh": "中国大陆、欧盟、日本", "en": "Mainland China, EU, Japan" }, "status": { "zh": "待逐项建立市场记录", "en": "Market record not established" }, "detail": { "zh": "不从美国标签档案推定当地批准、持有人、规格、供应或可售资格。", "en": "No local approval, holder, strength, supply or sale-eligibility conclusion is inferred from the U.S. label archive." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "标签档案能代表现在的产品信息吗？", "en": "Does a label archive represent current product information?" }, "answer": { "zh": "不能自动代表。档案用于定位来源；需要以目标市场的现行官方标签逐项复核。", "en": "Not automatically. The archive locates a source; each point needs verification against the target market’s current official label." } }, { "question": { "zh": "为什么这里不展示价格或原研/仿制结论？", "en": "Why are price and originator/generic conclusions not shown?" }, "answer": { "zh": "这些结论需要产品、剂型、规格、包装、市场、日期和原始记录分别齐全并经人工审核；单一标签文件不足以支持。", "en": "Those conclusions require separately complete and human-reviewed product, dosage-form, strength, pack, market, date and primary-record fields; one label file is insufficient." } } ], "relatedMedicineChecks": [ { "target": { "id": "coumadin", "brand": "Coumadin", "generic": "华法林钠", "canonicalUrls": { "zh": "https://origindrug.com/drugs/coumadin/", "en": "https://origindrug.com/en/drugs/coumadin/" } }, "title": { "zh": "与 COUMADIN／华法林同在药单上时：治疗窗较窄的口服药先做完整核对", "en": "When COUMADIN / warfarin is on the same list: review a narrow-therapeutic-index oral medicine first" }, "summary": { "zh": "FDA 的 2025 TRULICITY 标签说明其可延缓胃排空，可能降低同用口服药的吸收速率；并明确将华法林列为治疗窗较窄、需要由专业人员监测药物水平的口服药示例。这张卡只提示把华法林、TRULICITY、所有实际药盒、非处方药和补充剂交给药师或开方团队核对；它不提供个人监测目标、给药间隔或调整方案，也不建议自行停用、错开时间、替换或调整任何一种药。", "en": "The FDA's 2025 TRULICITY label says it delays gastric emptying and may reduce the rate of absorption of concomitant oral medicines; it names warfarin as an example of an oral medicine with a narrow therapeutic index for which professionals monitor drug levels. This card only signals that warfarin, TRULICITY, every actual pack, OTC product and supplement should be reviewed by a pharmacist or prescriber; it provides no individual monitoring target, timing interval or adjustment plan and does not decide co-use or advise self-stopping, time-separation, replacement or adjustment of either medicine." }, "source": { "id": "src_198d9ae73f3553a3", "label": "FDA：TRULICITY 2025 美国处方信息（7.1 Oral Medications：华法林为治疗窗较窄口服药示例）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/125469s063lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "review_complete_medicine_list_no_self_directed_change" } ], "relatedArticleSlugs": [ "dosage-forms-are-part-of-medicine-identity", "medicine-label-for-everyday-questions", "how-to-read-a-drug-label" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/trulicity/", "en": "https://origindrug.com/en/drugs/trulicity/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "actos", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-23", "status": "published_traceable_archive" }, "names": { "brand": "Actos", "generic": "吡格列酮", "aliases": [ "ACTOS", "pioglitazone", "吡格列酮" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "代谢", "sourceArchiveMarket": "美国：DailyMed 当前 ACTOS 处方药公开标签（2025-03-28 更新；仅建立所引文件的阅读与包装身份核对入口）。不从这一美国文件推定中国大陆、欧盟、日本或其他市场的商品名、批准、供应、可售资格或可替代性。", "dosageFormClass": "ACTOS 吡格列酮普通口服片：15、30、45 mg（美国公开标签所列；本页分别建立三个 30 片瓶装面板，不将 90 片、500 片、6 片托盘或其他市场包装合并）", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "1999（DailyMed 当前美国公开标签所列 Initial U.S. Approval）", "archiveSponsorText": "Takeda Pharmaceuticals America, Inc. / DailyMed（NLM）当前美国公开标签" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-actos-pioglitazone-tablet-15mg-30-bottle-ndc-64764-151-04", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前公开标签（2025-03-28 更新）", "en": "Current U.S. DailyMed public label (updated 28 Mar 2025)" }, "dosageForm": { "zh": "ACTOS 吡格列酮普通口服片", "en": "ACTOS pioglitazone immediate-release oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 64764-151-04", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片吡格列酮 15 mg；30 片瓶装", "en": "Pioglitazone 15 mg per tablet; 30-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=actos-03.jpg&setid=d2ddc491-88a9-4063-9150-443b4fa4330c&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "吡格列酮", "en": "pioglitazone" }, "value": 15, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签量；不是个人片数、调量、联用、停用或换药规则", "en": "labelled amount per tablet; not an individual's tablet count, adjustment, combination, stopping or switching rule" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-23", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 30, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "白色至类白色", "en": "white to off-white" }, "shape": { "zh": "圆形、凸面、无刻痕片", "en": "round, convex, unscored tablet" }, "imprint": { "zh": "一面 ACTOS；另一面 15", "en": "ACTOS on one face; 15 on the other" }, "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_120566a14186b72d", "label": "DailyMed（NLM）：ACTOS 吡格列酮普通片当前美国公开标签（Takeda；2025-03-28 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d2ddc491-88a9-4063-9150-443b4fa4330c", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-actos-pioglitazone-tablet-30mg-30-bottle-ndc-64764-301-14", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前公开标签（2025-03-28 更新）", "en": "Current U.S. DailyMed public label (updated 28 Mar 2025)" }, "dosageForm": { "zh": "ACTOS 吡格列酮普通口服片", "en": "ACTOS pioglitazone immediate-release oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 64764-301-14", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片吡格列酮 30 mg；30 片瓶装", "en": "Pioglitazone 30 mg per tablet; 30-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=actos-04.jpg&setid=d2ddc491-88a9-4063-9150-443b4fa4330c&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "吡格列酮", "en": "pioglitazone" }, "value": 30, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签量；不是个人片数、调量、联用、停用或换药规则", "en": "labelled amount per tablet; not an individual's tablet count, adjustment, combination, stopping or switching rule" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-23", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 30, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "白色至类白色", "en": "white to off-white" }, "shape": { "zh": "圆形、平面、无刻痕片", "en": "round, flat, unscored tablet" }, "imprint": { "zh": "一面 ACTOS；另一面 30", "en": "ACTOS on one face; 30 on the other" }, "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_120566a14186b72d", "label": "DailyMed（NLM）：ACTOS 吡格列酮普通片当前美国公开标签（Takeda；2025-03-28 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d2ddc491-88a9-4063-9150-443b4fa4330c", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-actos-pioglitazone-tablet-45mg-30-bottle-ndc-64764-451-24", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前公开标签（2025-03-28 更新）", "en": "Current U.S. DailyMed public label (updated 28 Mar 2025)" }, "dosageForm": { "zh": "ACTOS 吡格列酮普通口服片", "en": "ACTOS pioglitazone immediate-release oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 64764-451-24", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片吡格列酮 45 mg；30 片瓶装", "en": "Pioglitazone 45 mg per tablet; 30-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=actos-05.jpg&setid=d2ddc491-88a9-4063-9150-443b4fa4330c&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "吡格列酮", "en": "pioglitazone" }, "value": 45, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签量；不是个人片数、调量、联用、停用或换药规则", "en": "labelled amount per tablet; not an individual's tablet count, adjustment, combination, stopping or switching rule" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-23", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 30, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "白色至类白色", "en": "white to off-white" }, "shape": { "zh": "圆形、平面、无刻痕片", "en": "round, flat, unscored tablet" }, "imprint": { "zh": "一面 ACTOS；另一面 45", "en": "ACTOS on one face; 45 on the other" }, "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_120566a14186b72d", "label": "DailyMed（NLM）：ACTOS 吡格列酮普通片当前美国公开标签（Takeda；2025-03-28 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d2ddc491-88a9-4063-9150-443b4fa4330c", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-actos-pioglitazone-tablet-15mg-30-bottle-ndc-64764-151-04", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=actos-03.jpg&setid=d2ddc491-88a9-4063-9150-443b4fa4330c&type=img", "alt": "ACTOS 吡格列酮 15 mg、NDC 64764-151-04、30 片瓶装在美国 DailyMed 当前公开标签中的展示面", "archiveMarket": "美国", "labelVersion": "DailyMed 当前公开标签（2025-03-28 更新）", "presentation": "ACTOS 吡格列酮普通口服片：每片 15 mg，NDC 64764-151-04，30 片瓶装展示面。", "notice": "此图只对应美国 DailyMed 当前公开标签中的 ACTOS、吡格列酮 15 mg、NDC 64764-151-04 与 30 片瓶装。它只帮助核对品牌、通用名、每片标示量、普通口服片、包装数量、外观线索与来源；不用于鉴定真伪，也不证明 30 mg、45 mg、90/500 片瓶装、6 片托盘、其他市场、原研身份、当前可得性、可替代性或任何个人的片数、调量、联用、停用或换药方案。", "source": { "id": "src_120566a14186b72d", "label": "DailyMed（NLM）：ACTOS 吡格列酮普通片当前美国公开标签（Takeda；2025-03-28 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d2ddc491-88a9-4063-9150-443b4fa4330c", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "ACTOS 说明书放大阅读：降糖药的 mg 不是可与其他药自行拼加的数字", "en": "ACTOS label reading: a glucose-medicine mg marking is not a number to self-combine" }, "summary": { "zh": "本模块以 DailyMed 当前美国公开标签为阅读入口，帮助核对 ACTOS、吡格列酮、普通口服片、每片标示强度、准确瓶装与完整降糖药单；它不制定个人剂量、联合方案、停药或转换方案。", "en": "This module uses the current U.S. DailyMed public label as a reading entry point. It helps check ACTOS, pioglitazone, immediate-release oral tablets, labelled amount per tablet, exact bottles and the complete glucose-medicine list; it does not set individual dose, combination, stopping or switching plans." }, "checks": [ { "zh": "先把 ACTOS、吡格列酮、口服片剂、每片标示强度和目标市场一起核对。相同的“降糖”用途或相近 mg 数字，不能证明与二甲双胍、胰岛素、磺脲类或其他产品可自行叠加、轮换或替换。", "en": "Check ACTOS, pioglitazone, oral tablet, labelled strength per tablet and target market together. A shared glucose-lowering purpose or nearby mg number does not prove it can be self-combined, alternated or substituted with metformin, insulin, sulfonylureas or another product." }, { "zh": "标签提示液体潴留和心力衰竭相关风险需要注意。体重快速变化、肿胀、呼吸不适或其他新症状不能被网页诊断；应带实际包装和完整药单及时联系当地医疗与开方团队。", "en": "The label flags fluid-retention and heart-failure-related risks for attention. Rapid weight change, swelling, breathing symptoms or another new concern cannot be diagnosed by a webpage; bring the actual package and complete medicine list to local medical and prescribing teams promptly." }, { "zh": "与胰岛素或其他降糖药同用时，标签相关风险不能只靠品牌名称排除。不要因为一次血糖、少吃一餐、运动变化或担心不适而自行多吃、少吃、补服或停用。", "en": "With insulin or another glucose-lowering medicine, relevant label risks cannot be excluded by brand name alone. Do not self-increase, reduce, make up or stop because of one glucose value, a missed meal, exercise change or concern about symptoms." }, { "zh": "任何肝脏、心脏、眼部、骨骼或妊娠相关问题，以及开始、停用或转换方案，都需由专业人员结合准确产品和现行标签判断。", "en": "Any liver, heart, eye, bone or pregnancy-related issue, and any start, stop or conversion plan, need professional judgement using the exact product and current label." } ], "source": { "id": "src_120566a14186b72d", "label": "DailyMed（NLM）：ACTOS 吡格列酮普通片当前美国公开标签（Takeda；2025-03-28 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d2ddc491-88a9-4063-9150-443b4fa4330c", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "吡格列酮怎样起作用：它激活 PPAR-γ 核受体", "en": "How pioglitazone works: it activates the PPAR-gamma nuclear receptor" }, "summary": { "zh": "当前美国标签将吡格列酮描述为噻唑烷二酮类，并说明其主要通过激活 PPAR-γ 核受体提高胰岛素敏感性。这个机制不预测个人血糖、体重、水肿、适用性或是否应和其他降糖药同用。", "en": "The current U.S. label describes pioglitazone as a thiazolidinedione that primarily improves insulin sensitivity through activation of the PPAR-gamma nuclear receptor. This mechanism does not predict an individual’s glucose, weight, oedema, suitability or use with another glucose medicine." }, "checks": [ { "zh": "“提高胰岛素敏感性”不表示可依据一次血糖或饮食变化自行加量、减量或停药。产品强度、适用情形和完整药单必须由专业人员核对。", "en": "“Improving insulin sensitivity” does not permit self-increase, reduction or stopping from one glucose value or food change. Product strength, context and the complete medicine list need professional review." }, { "zh": "同一机制不使 ACTOS 与胰岛素、二甲双胍、SGLT2、GLP-1 或其他产品可自行叠加、替换或轮换。药物类别相同或不同都需要逐项核对。", "en": "The same mechanism does not make ACTOS self-combinable, substitutable or alternatable with insulin, metformin, SGLT2, GLP-1 or another product. Every drug class, whether the same or different, needs item-by-item review." }, { "zh": "液体潴留、心脏相关风险或其他新症状的判断不能从机制页面得出。请依据现行标签、实际情况和当地医疗支持及时处理。", "en": "Fluid retention, heart-related risk or another new symptom cannot be determined from a mechanism page. Use the current label, real circumstances and local medical support for timely care." } ], "source": { "id": "src_120566a14186b72d", "label": "DailyMed（NLM）：ACTOS 吡格列酮普通片当前美国公开标签（Takeda；2025-03-28 更新；Clinical Pharmacology）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d2ddc491-88a9-4063-9150-443b4fa4330c", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "Actos", "generic": "吡格列酮", "dosageFormClass": "ACTOS 吡格列酮普通口服片：15、30、45 mg（美国公开标签所列；本页分别建立三个 30 片瓶装面板，不将 90 片、500 片、6 片托盘或其他市场包装合并）" }, "labelSource": { "id": "src_120566a14186b72d", "label": "DailyMed（NLM）：ACTOS 吡格列酮普通片当前美国公开标签（Takeda；2025-03-28 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d2ddc491-88a9-4063-9150-443b4fa4330c", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "productRoutes": [ { "source": { "id": "src_120566a14186b72d", "label": "DailyMed（NLM）：ACTOS 吡格列酮普通片当前美国公开标签（Takeda；2025-03-28 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d2ddc491-88a9-4063-9150-443b4fa4330c", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-23", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-23", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "DailyMed 的当前 ACTOS（pioglitazone）美国公开标签将 15、30、45 mg 分列为普通口服片。本页只帮助核对品牌、通用名、每片标示量、准确 30 片瓶装、NDC、外观线索、目标市场与来源；不把包装数字或 mg 转成任何人的片数、血糖处理、联用、停用、转换或购买结论。", "history": "当前美国公开标签列示 Initial U.S. Approval: 1999，并于 2025-03-28 更新。15、30、45 mg、30/90/500 片瓶装和 6 片托盘是不同的标签身份字段；相同品牌、成分或“降糖”用途都不能使包装、规格、市场或另一类降糖药成为可自行替代、叠加或轮换的产品。", "sourceDocuments": [ { "id": "src_120566a14186b72d", "label": "DailyMed（NLM）：ACTOS 吡格列酮普通片当前美国公开标签（Takeda；2025-03-28 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d2ddc491-88a9-4063-9150-443b4fa4330c", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" } ], "applicationNumber": "DailyMed 当前美国公开标签所列 New Drug Application 记录（本档案不另行断言具体申请号）", "approvalTimeline": [ { "date": "1999", "title": { "zh": "FDA 标签所列美国初始批准年份", "en": "Initial U.S. approval year listed in the FDA label" }, "detail": { "zh": "本页链接的 FDA 标签档案列示 Initial U.S. Approval: 1999。该历史定位不等同于当前批准、可得性、持有人或其他市场状态。", "en": "The FDA label archive linked here lists Initial U.S. Approval: 1999. This historical locator is not a conclusion about current approval, availability, holder or another market." }, "source": { "id": "src_120566a14186b72d", "label": "DailyMed: ACTOS current U.S. public label", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d2ddc491-88a9-4063-9150-443b4fa4330c", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" } }, { "date": "2025-03-28", "title": { "zh": "FDA 标签档案版本", "en": "FDA label archive version" }, "detail": { "zh": "本页链接 2025-03-28 的 FDA 标签档案作为可复核阅读入口。现行标签、规格、适应症和安全信息必须另行以目标市场当前文件核对。", "en": "This page links the 2025-03-28 FDA label archive as a traceable reading entry point. Current labeling, strength, indication and safety information require separate verification against the target market’s current document." }, "source": { "id": "src_120566a14186b72d", "label": "DailyMed: ACTOS current U.S. public label", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d2ddc491-88a9-4063-9150-443b4fa4330c", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "已链接公开标签档案", "en": "Public label archive linked" }, "detail": { "zh": "仅对应本页所列 FDA 文件。", "en": "Only the FDA document listed on this page is linked." } }, { "market": { "zh": "中国大陆、欧盟、日本", "en": "Mainland China, EU, Japan" }, "status": { "zh": "待逐项建立市场记录", "en": "Market record not established" }, "detail": { "zh": "不从美国标签档案推定当地批准、持有人、规格、供应或可售资格。", "en": "No local approval, holder, strength, supply or sale-eligibility conclusion is inferred from the U.S. label archive." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "标签档案能代表现在的产品信息吗？", "en": "Does a label archive represent current product information?" }, "answer": { "zh": "不能自动代表。档案用于定位来源；需要以目标市场的现行官方标签逐项复核。", "en": "Not automatically. The archive locates a source; each point needs verification against the target market’s current official label." } }, { "question": { "zh": "为什么这里不展示价格或原研/仿制结论？", "en": "Why are price and originator/generic conclusions not shown?" }, "answer": { "zh": "这些结论需要产品、剂型、规格、包装、市场、日期和原始记录分别齐全并经人工审核；单一标签文件不足以支持。", "en": "Those conclusions require separately complete and human-reviewed product, dosage-form, strength, pack, market, date and primary-record fields; one label file is insufficient." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "how-to-read-a-drug-label", "regulatory-sources-first" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/actos/", "en": "https://origindrug.com/en/drugs/actos/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "precose", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-23", "status": "published_traceable_archive" }, "names": { "brand": "Precose", "generic": "阿卡波糖", "aliases": [ "acarbose", "阿卡波糖", "拜唐苹", "Glucobay", "阿卡波糖片" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": { "value": "拜唐苹®", "status": "discovery_cue_requires_target_market_verification", "source": { "id": "src_281bcdb5add33c39", "label": "泾县人民政府：医保高值药品参考清单中的拜唐苹／阿卡波糖片记录", "url": "https://www.ahxx.gov.cn/group1/M00/47/45/Cpc8VmZo5wiAK4pvAAM6bEblTyM892.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "government_medicine_listing", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-12", "reviewedAt": "2026-09-12" } } }, "identity": { "therapeuticArea": "代谢", "sourceArchiveMarket": "美国 PRECOSE 拜耳历史公开标签（DailyMed，生效 2020-02-29；三个 NDC 的产品数据均列示该日营销结束）。本页只展示该历史文件中的三种准确 100 片瓶装；拜耳中国官网可确认“拜唐苹®”为其处方药组合中的名称，但不替代中国大陆现行标签或批准记录。", "dosageFormClass": "口服片：25 mg、50 mg、100 mg（美国拜耳历史公开标签所列；每个包装分别核对）", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "1995（FDA NDA 020482 原始审批资料）", "archiveSponsorText": "Bayer / DailyMed 公开标签档案；拜耳中国历史公开产品组合线索" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [ "NDC 43353-908", "43353-908", "Aphena Pharma Solutions", "Acarbose (Precose) 50 mg 9000 tablets" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-precose-acarbose-historical-tablet-25mg-ndc-50419-863-51", "marketCode": "US", "labelVersion": { "zh": "DailyMed 美国拜耳历史公开标签（生效 2020-02-29；产品记录列示该日营销结束）", "en": "DailyMed U.S. Bayer historical public label (effective 29 Feb 2020; product data list marketing end on that date)" }, "dosageForm": { "zh": "阿卡波糖口服片（历史标签）", "en": "acarbose oral tablet (historical label)" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 50419-863-51", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片阿卡波糖 25 mg；100 片瓶装（拜耳历史标签展示面）", "en": "Acarbose 25 mg per tablet; 100-tablet bottle (Bayer historical-label panel)" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=image-04.jpg&archiveid=673217", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "阿卡波糖", "en": "acarbose" }, "value": 25, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片历史标签标示量；不是个人片数、调整或换算指令", "en": "historical labelled amount per tablet; not an individual tablet count, adjustment or conversion instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": null, "package": { "count": 100, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "白色至淡黄色", "en": "white to pale yellow" }, "shape": { "zh": "圆形、无刻痕片", "en": "round, unscored tablet" }, "imprint": { "zh": "PRECOSE（单面）／25（另一面）", "en": "PRECOSE (one side) / 25 (other side)" }, "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_bf404e15cfbd9719", "label": "DailyMed（NLM）：PRECOSE 阿卡波糖美国拜耳历史公开标签（生效 2020-02-29；准确包装展示面）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=29a6f213-bc93-4dbd-bab0-744722b6f0b8", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-precose-acarbose-historical-tablet-50mg-ndc-50419-861-51", "marketCode": "US", "labelVersion": { "zh": "DailyMed 美国拜耳历史公开标签（生效 2020-02-29；产品记录列示该日营销结束）", "en": "DailyMed U.S. Bayer historical public label (effective 29 Feb 2020; product data list marketing end on that date)" }, "dosageForm": { "zh": "阿卡波糖口服片（历史标签）", "en": "acarbose oral tablet (historical label)" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 50419-861-51", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片阿卡波糖 50 mg；100 片瓶装（拜耳历史标签展示面）", "en": "Acarbose 50 mg per tablet; 100-tablet bottle (Bayer historical-label panel)" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=image-05.jpg&archiveid=673217", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "阿卡波糖", "en": "acarbose" }, "value": 50, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片历史标签标示量；不是个人片数、调整或换算指令", "en": "historical labelled amount per tablet; not an individual tablet count, adjustment or conversion instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": null, "package": { "count": 100, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "白色至淡黄色", "en": "white to pale yellow" }, "shape": { "zh": "圆形、无刻痕片", "en": "round, unscored tablet" }, "imprint": { "zh": "PRECOSE / 50（同面）", "en": "PRECOSE / 50 (same side)" }, "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_bf404e15cfbd9719", "label": "DailyMed（NLM）：PRECOSE 阿卡波糖美国拜耳历史公开标签（生效 2020-02-29；准确包装展示面）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=29a6f213-bc93-4dbd-bab0-744722b6f0b8", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-precose-acarbose-historical-tablet-100mg-ndc-50419-862-51", "marketCode": "US", "labelVersion": { "zh": "DailyMed 美国拜耳历史公开标签（生效 2020-02-29；产品记录列示该日营销结束）", "en": "DailyMed U.S. Bayer historical public label (effective 29 Feb 2020; product data list marketing end on that date)" }, "dosageForm": { "zh": "阿卡波糖口服片（历史标签）", "en": "acarbose oral tablet (historical label)" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 50419-862-51", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片阿卡波糖 100 mg；100 片瓶装（拜耳历史标签展示面）", "en": "Acarbose 100 mg per tablet; 100-tablet bottle (Bayer historical-label panel)" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=image-06.jpg&archiveid=673217", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "阿卡波糖", "en": "acarbose" }, "value": 100, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片历史标签标示量；不是个人片数、调整或换算指令", "en": "historical labelled amount per tablet; not an individual tablet count, adjustment or conversion instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": null, "package": { "count": 100, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "白色至淡黄色", "en": "white to pale yellow" }, "shape": { "zh": "圆形、无刻痕片", "en": "round, unscored tablet" }, "imprint": { "zh": "PRECOSE / 100（同面）", "en": "PRECOSE / 100 (same side)" }, "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_bf404e15cfbd9719", "label": "DailyMed（NLM）：PRECOSE 阿卡波糖美国拜耳历史公开标签（生效 2020-02-29；准确包装展示面）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=29a6f213-bc93-4dbd-bab0-744722b6f0b8", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-precose-acarbose-historical-tablet-25mg-ndc-50419-863-51", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=image-04.jpg&archiveid=673217", "alt": "PRECOSE 阿卡波糖美国拜耳历史公开标签中的 25 mg、NDC 50419-863-51、100 片瓶装展示面", "archiveMarket": "美国", "labelVersion": "DailyMed 拜耳历史公开标签，生效 2020-02-29；产品数据列示同日营销结束", "presentation": "PRECOSE：每片阿卡波糖 25 mg，NDC 50419-863-51，100 片瓶装历史展示面。", "notice": "此图只对应美国 DailyMed 拜耳历史公开标签中的 PRECOSE、阿卡波糖 25 mg、NDC 50419-863-51 与 100 片瓶装。它只帮助核对商品名、通用名、每片标签量、包装、外形线索和来源；不用于鉴定真伪，也不证明 50 mg／100 mg、其他包装、其他市场、当前可得性、原研身份、可替代性或任何个人使用方案。", "source": { "id": "src_bf404e15cfbd9719", "label": "DailyMed（NLM）：PRECOSE 阿卡波糖美国拜耳历史公开标签（生效 2020-02-29；准确包装展示面）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=29a6f213-bc93-4dbd-bab0-744722b6f0b8", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "PRECOSE / 拜唐苹说明书放大阅读：25 mg、50 mg、100 mg 首先用于确认准确片剂", "en": "PRECOSE / Glucobay label reading: 25 mg, 50 mg and 100 mg first identify the exact tablet" }, "summary": { "zh": "本模块以 FDA/DailyMed 的 PRECOSE 历史公开标签为阅读入口，并保留拜耳中国的中文名称线索。它帮助核对 PRECOSE、阿卡波糖、拜唐苹/Glucobay、口服片、每片标示量和目标市场；不提供任何人的片数、服药时点、联合方案、转换或停药方案。", "en": "This module uses the FDA/DailyMed historical PRECOSE public label and preserves Bayer China's Chinese trade-name clue. It helps check PRECOSE, acarbose, 拜唐苹/Glucobay, oral tablet, labelled amount per tablet and target market; it does not provide anyone's tablet count, timing, combination, switching or stopping plan." }, "checks": [ { "zh": "25 mg、50 mg、100 mg 是历史美国标签所列每片标示量，不是“今天应吃几片”的答案。应同时核对商品名、通用名、准确片剂、每片标示量、实际包装、标签版本和目标市场；任何一项不同都不能自行按 mg 换算、拼量或替换。", "en": "25 mg, 50 mg and 100 mg are labelled amounts per tablet in the historical U.S. label, not an answer to ‘how many tablets today.’ Check trade name, generic name, exact tablet, amount per tablet, actual pack, label version and target market together; a difference in any one does not permit self-conversion, combining strengths or substitution." }, { "zh": "“拜唐苹®”是拜耳中国官网可追溯的中文产品名称线索；它不能单独证明手上药盒的批准文号、生产者、规格、包装外观或当前状态。对照时应把药盒全部文字、通用名和官方现行记录一起交给药师或医生核对。", "en": "‘拜唐苹®’ is a traceable Chinese product-name clue on Bayer China's website; it alone cannot establish the approval number, manufacturer, strength, package appearance or current status of a pack in hand. For comparison, have a pharmacist or clinician review all pack text, the generic name and the current official record together." }, { "zh": "该标签列有消化道反应、肝功能、血糖变化和与其他降糖治疗共同使用时的核对事项。正在使用其他降糖药、胰岛素、保健品或多种处方/非处方药时，应携带完整药单和实际包装让专业人员核对；网页不能判断个人是否应联用、调整或换药。", "en": "The label contains checks involving gastrointestinal effects, liver function, glucose changes and co-use with other glucose-lowering treatment. With other glucose medicines, insulin, supplements or multiple prescription/OTC products, take the complete medicine list and actual packs for professional review; a webpage cannot decide whether an individual should combine, adjust or switch." }, { "zh": "持续或严重腹痛、呕吐、脱水、意识改变、疑似低血糖不适、严重过敏表现或其他急性问题，不能按网页或包装数字自行处理。应及时使用当地医疗支持，而不是自行加量、补用、停用或改用另一种降糖产品。", "en": "Persistent or severe abdominal pain, vomiting, dehydration, altered awareness, suspected low-glucose symptoms, severe allergic features or another acute problem cannot be managed from a webpage or package numbers. Use timely local medical support rather than self-increasing, catch-up use, stopping or changing to another glucose-lowering product." } ], "source": { "id": "src_bf404e15cfbd9719", "label": "DailyMed（NLM）：PRECOSE 阿卡波糖美国拜耳历史公开标签（生效 2020-02-29）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=29a6f213-bc93-4dbd-bab0-744722b6f0b8", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "阿卡波糖怎样起作用：标签描述其延缓膳食碳水化合物的消化", "en": "How acarbose works: the label describes delayed digestion of dietary carbohydrate" }, "summary": { "zh": "DailyMed 历史公开标签将 PRECOSE 描述为 α-葡萄糖苷酶抑制剂，并说明阿卡波糖可延缓摄入碳水化合物的消化。这解释的是标签中的药理路径，不能判断个人血糖问题、饮食选择、片数、用药时点、联用或调整方案。", "en": "The DailyMed historical public label describes PRECOSE as an alpha-glucosidase inhibitor and explains that acarbose delays digestion of ingested carbohydrate. This describes a labelled pharmacologic pathway; it cannot determine an individual's glucose issue, dietary choices, tablet count, timing, combination or adjustment plan." }, "checks": [ { "zh": "“延缓碳水化合物消化”不是对任何人血糖结果、饮食或治疗需要的判断。空腹或餐后数字、症状、既往处方和其他药物都需要由当地医疗团队结合准确产品与检查资料解读。", "en": "‘Delays carbohydrate digestion’ is not a judgement about anyone's glucose result, diet or treatment need. Fasting or post-meal values, symptoms, prior prescriptions and other medicines require interpretation by a local care team together with the exact product and test information." }, { "zh": "相同的降糖类别描述或相近的包装数字，不使阿卡波糖与另一种降糖药、胰岛素、保健品或不同强度片剂可以自行叠加、轮换、按 mg 换算或替换。完整药单和现行标签应由专业人员一起核对。", "en": "A shared glucose-lowering class description or similar package number does not make acarbose self-combinable, alternatable, milligram-convertible or substitutable with another glucose medicine, insulin, supplement or different-strength tablet. The complete medicine list and current label need professional review together." }, { "zh": "机制说明不取代对急性不适、反复低血糖样症状、胃肠道问题、肝脏问题或任何新症状的处理。出现急性或严重问题时，应优先使用当地紧急医疗支持。", "en": "A mechanism explanation does not replace care for acute concerns, repeated low-glucose-like symptoms, gastrointestinal issues, liver concerns or any new symptom. With an acute or serious problem, prioritise local urgent medical support." } ], "source": { "id": "src_bf404e15cfbd9719", "label": "DailyMed（NLM）：PRECOSE 阿卡波糖美国拜耳历史公开标签（Clinical Pharmacology；生效 2020-02-29）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=29a6f213-bc93-4dbd-bab0-744722b6f0b8", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "Precose", "generic": "阿卡波糖", "dosageFormClass": "口服片：25 mg、50 mg、100 mg（美国拜耳历史公开标签所列；每个包装分别核对）" }, "labelSource": { "id": "src_bf404e15cfbd9719", "label": "DailyMed（NLM）：PRECOSE 阿卡波糖美国拜耳历史公开标签（生效 2020-02-29；三个准确包装展示面）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=29a6f213-bc93-4dbd-bab0-744722b6f0b8", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "productRoutes": [ { "source": { "id": "src_bf404e15cfbd9719", "label": "DailyMed（NLM）：PRECOSE 阿卡波糖美国拜耳历史公开标签（生效 2020-02-29；三个准确包装展示面）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=29a6f213-bc93-4dbd-bab0-744722b6f0b8", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-23", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-23", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "DailyMed 的 PRECOSE（acarbose）拜耳历史公开标签列示 25 mg、50 mg、100 mg 口服片，并为三个准确 NDC 保留各自的 100 片瓶装展示面。该来源产品数据列示 2020-02-29 为美国营销结束日期，因此页面不把图片或标签表述为当前在售、可购或现行外观。拜耳中国官网将“拜唐苹®”列入其处方药组合，可作为中文商品名的来源线索。页面帮助读者把品牌、通用名、每片标示量、剂型、目标市场和实际包装一起核对；不据此生成个人片数、用药时间、联用、转换或停药方案。", "history": "FDA 的 NDA 020482 原始审批资料记录 PRECOSE 的 1995 年审批文件；DailyMed 的拜耳历史公开标签则可追溯 25 mg（NDC 50419-863-51）、50 mg（NDC 50419-861-51）和 100 mg（NDC 50419-862-51）三个 100 片瓶装的准确展示面。三个产品数据均列示 2020-02-29 为美国营销结束日期，因此不证明现行供应、现行外观或任何市场的当前状态。两类文件的用途不同：前者用于历史审批定位，后者用于历史包装与标签阅读；均不等于中国大陆现行说明书、当前批准、医保、供应或个体化治疗结论。", "sourceDocuments": [ { "id": "src_43390a0ac784bf5e", "label": "FDA：PRECOSE（acarbose）NDA 020482 原始审批资料（1995）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/020482Orig1s000rev.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "approval_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_bf404e15cfbd9719", "label": "DailyMed（NLM）：PRECOSE 阿卡波糖美国拜耳历史公开标签（生效 2020-02-29；三个准确包装展示面）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=29a6f213-bc93-4dbd-bab0-744722b6f0b8", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, { "id": "src_ef8b678b4ed549bf", "label": "拜耳中国：处方药产品组合中的拜唐苹®名称线索（历史公开页）", "url": "https://www.bayer.com.cn/zh-hans/divisions", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "first_party_product_page", "market": "CN", "accessStatus": "public_access_with_site_controls", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } ], "applicationNumber": "NDA 020482", "approvalTimeline": [ { "date": "1995-09-06", "title": { "zh": "FDA NDA 020482 原始审批", "en": "FDA NDA 020482 original approval" }, "detail": { "zh": "FDA Drugs@FDA 记录显示 PRECOSE（acarbose）NDA 020482 的原始申请于 1995-09-06 获批。所链接的历史审评文件在 2019 年公开；该文件日期不等同于原始审批日期。该历史节点不代表当前标签、规格、持有人、供应或其他市场状态。", "en": "FDA Drugs@FDA records the original PRECOSE (acarbose) application, NDA 020482, as approved on 1995-09-06. The linked historical review document was made public in 2019; its document date is not the original approval date. This historical point does not establish current labelling, strength, holder, supply or another-market status." }, "source": { "id": "src_43390a0ac784bf5e", "label": "FDA: PRECOSE (acarbose) NDA 020482 original approval record (1995)", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/020482Orig1s000rev.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "approval_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, { "date": "2020-02-29", "title": { "zh": "拜耳历史标签生效及产品数据列示营销结束", "en": "Historical Bayer label effective date and marketing-end date listed in product data" }, "detail": { "zh": "所引 DailyMed 拜耳历史公开标签标示生效日期为 2020-02-29，三个产品数据均列示该日为营销结束日期。该节点使本页图片限定为历史包装核对，不建立当前在售、库存、可购、可替代或其他市场状态。", "en": "The cited DailyMed Bayer historical public label is effective 29 Feb 2020, and each of the three product data entries lists that date as marketing end. This confines the page images to historical package checking and does not establish current marketing, stock, purchase, interchangeability or another-market status." }, "source": { "id": "src_bf404e15cfbd9719", "label": "DailyMed: PRECOSE historical Bayer public label (effective 29 Feb 2020; marketing end listed in product data)", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=29a6f213-bc93-4dbd-bab0-744722b6f0b8", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "已链接公开标签档案", "en": "Public label archive linked" }, "detail": { "zh": "仅对应本页所列 FDA 文件。", "en": "Only the FDA document listed on this page is linked." } }, { "market": { "zh": "中国大陆、欧盟、日本", "en": "Mainland China, EU, Japan" }, "status": { "zh": "待逐项建立市场记录", "en": "Market record not established" }, "detail": { "zh": "不从美国标签档案推定当地批准、持有人、规格、供应或可售资格。", "en": "No local approval, holder, strength, supply or sale-eligibility conclusion is inferred from the U.S. label archive." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "标签档案能代表现在的产品信息吗？", "en": "Does a label archive represent current product information?" }, "answer": { "zh": "不能自动代表。档案用于定位来源；需要以目标市场的现行官方标签逐项复核。", "en": "Not automatically. The archive locates a source; each point needs verification against the target market’s current official label." } }, { "question": { "zh": "为什么这里不展示价格或原研/仿制结论？", "en": "Why are price and originator/generic conclusions not shown?" }, "answer": { "zh": "这些结论需要产品、剂型、规格、包装、市场、日期和原始记录分别齐全并经人工审核；单一标签文件不足以支持。", "en": "Those conclusions require separately complete and human-reviewed product, dosage-form, strength, pack, market, date and primary-record fields; one label file is insufficient." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "how-to-read-a-drug-label", "regulatory-sources-first" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/precose/", "en": "https://origindrug.com/en/drugs/precose/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "synthroid", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-21", "status": "published_traceable_archive" }, "names": { "brand": "Synthroid", "generic": "左甲状腺素", "aliases": [ "levothyroxine" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "代谢", "sourceArchiveMarket": "美国 SYNTHROID 公开标签（DailyMed 页面 2024-02-20 更新；处方信息 2024-02 修订）", "dosageFormClass": "左甲状腺素钠口服片：25、50、75、88、100、112、125、137、150、175、200、300 mcg（本档案分别展示 12 个美国标签包装面板）", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "2002（DailyMed 2024-02 美国公开标签所列 Initial U.S. Approval）", "archiveSponsorText": "AbbVie Inc. / DailyMed（NLM）美国公开标签" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-synthroid-levothyroxine-tablet-25mcg-0074434119", "marketCode": "US", "labelVersion": { "zh": "DailyMed 页面 2024-02-20 更新；处方信息 2024-02 修订", "en": "DailyMed updated 20 Feb 2024; prescribing information revised Feb 2024" }, "dosageForm": { "zh": "左甲状腺素钠口服片", "en": "levothyroxine sodium oral tablet" }, "route": { "zh": "口服（仅作标签产品身份字段）", "en": "oral (label product-identity field only)" }, "routeCodes": [ "oral" ], "productCode": "NDC 0074-4341-19", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片 25 mcg（0.025 mg）；1000 片瓶装", "en": "25 mcg (0.025 mg) per tablet; 1000-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=1e11ad30-1041-4520-10b0-8f9d30d30fcc&name=synthroid-spl-06.jpg", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "左甲状腺素钠", "en": "levothyroxine sodium" }, "value": 25, "unit": "mcg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人服用片数、调量或换算指令", "en": "labelled amount per tablet; not an individual tablet count, adjustment or conversion instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "原瓶", "en": "bottle" }, "fill": null, "countPerPackage": 1000, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-21", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 1000, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "橙色", "en": "orange" }, "shape": { "zh": "圆形片", "en": "round tablet" }, "imprint": "SYNTHROID / 25", "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_9fe75faad23655ce", "label": "DailyMed（NLM）：SYNTHROID 左甲状腺素钠美国公开标签（AbbVie；2024-02 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=1e11ad30-1041-4520-10b0-8f9d30d30fcc", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-synthroid-levothyroxine-tablet-50mcg-0074455211", "marketCode": "US", "labelVersion": { "zh": "DailyMed 页面 2024-02-20 更新；处方信息 2024-02 修订", "en": "DailyMed updated 20 Feb 2024; prescribing information revised Feb 2024" }, "dosageForm": { "zh": "左甲状腺素钠口服片", "en": "levothyroxine sodium oral tablet" }, "route": { "zh": "口服（仅作标签产品身份字段）", "en": "oral (label product-identity field only)" }, "routeCodes": [ "oral" ], "productCode": "NDC 0074-4552-11", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片 50 mcg（0.05 mg）；100 片纸盒（单位剂量包装）", "en": "50 mcg (0.05 mg) per tablet; 100-tablet carton (unit-dose package)" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=1e11ad30-1041-4520-10b0-8f9d30d30fcc&name=synthroid-spl-02.jpg", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "左甲状腺素钠", "en": "levothyroxine sodium" }, "value": 50, "unit": "mcg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人服用片数、调量或换算指令", "en": "labelled amount per tablet; not an individual tablet count, adjustment or conversion instruction" } } ], "concentration": null, "container": { "typeCode": "unit_dose_carton", "typeLabel": { "zh": "单位剂量纸盒", "en": "unit-dose carton" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "片/盒", "en": "tablets per carton" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-21", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "片/单位剂量纸盒", "en": "tablets per unit-dose carton" } }, "physicalClues": { "color": { "zh": "白色", "en": "white" }, "shape": { "zh": "圆形片", "en": "round tablet" }, "imprint": "SYNTHROID / 50", "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_9fe75faad23655ce", "label": "DailyMed（NLM）：SYNTHROID 左甲状腺素钠美国公开标签（AbbVie；2024-02 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=1e11ad30-1041-4520-10b0-8f9d30d30fcc", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-synthroid-levothyroxine-tablet-75mcg-0074518219", "marketCode": "US", "labelVersion": { "zh": "DailyMed 页面 2024-02-20 更新；处方信息 2024-02 修订", "en": "DailyMed updated 20 Feb 2024; prescribing information revised Feb 2024" }, "dosageForm": { "zh": "左甲状腺素钠口服片", "en": "levothyroxine sodium oral tablet" }, "route": { "zh": "口服（仅作标签产品身份字段）", "en": "oral (label product-identity field only)" }, "routeCodes": [ "oral" ], "productCode": "NDC 0074-5182-19", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片 75 mcg（0.075 mg）；1000 片瓶装", "en": "75 mcg (0.075 mg) per tablet; 1000-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=1e11ad30-1041-4520-10b0-8f9d30d30fcc&name=synthroid-spl-07.jpg", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "左甲状腺素钠", "en": "levothyroxine sodium" }, "value": 75, "unit": "mcg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人服用片数、调量或换算指令", "en": "labelled amount per tablet; not an individual tablet count, adjustment or conversion instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "原瓶", "en": "bottle" }, "fill": null, "countPerPackage": 1000, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-21", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 1000, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "紫色", "en": "violet" }, "shape": { "zh": "圆形片", "en": "round tablet" }, "imprint": "SYNTHROID / 75", "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_9fe75faad23655ce", "label": "DailyMed（NLM）：SYNTHROID 左甲状腺素钠美国公开标签（AbbVie；2024-02 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=1e11ad30-1041-4520-10b0-8f9d30d30fcc", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-synthroid-levothyroxine-tablet-88mcg-0074659490", "marketCode": "US", "labelVersion": { "zh": "DailyMed 页面 2024-02-20 更新；处方信息 2024-02 修订", "en": "DailyMed updated 20 Feb 2024; prescribing information revised Feb 2024" }, "dosageForm": { "zh": "左甲状腺素钠口服片", "en": "levothyroxine sodium oral tablet" }, "route": { "zh": "口服（仅作标签产品身份字段）", "en": "oral (label product-identity field only)" }, "routeCodes": [ "oral" ], "productCode": "NDC 0074-6594-90", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片 88 mcg（0.088 mg）；90 片瓶装", "en": "88 mcg (0.088 mg) per tablet; 90-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=1e11ad30-1041-4520-10b0-8f9d30d30fcc&name=synthroid-spl-08.jpg", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "左甲状腺素钠", "en": "levothyroxine sodium" }, "value": 88, "unit": "mcg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人服用片数、调量或换算指令", "en": "labelled amount per tablet; not an individual tablet count, adjustment or conversion instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "原瓶", "en": "bottle" }, "fill": null, "countPerPackage": 90, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-21", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 90, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "橄榄色", "en": "olive" }, "shape": { "zh": "圆形片", "en": "round tablet" }, "imprint": "SYNTHROID / 88", "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_9fe75faad23655ce", "label": "DailyMed（NLM）：SYNTHROID 左甲状腺素钠美国公开标签（AbbVie；2024-02 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=1e11ad30-1041-4520-10b0-8f9d30d30fcc", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-synthroid-levothyroxine-tablet-100mcg-0074662411", "marketCode": "US", "labelVersion": { "zh": "DailyMed 页面 2024-02-20 更新；处方信息 2024-02 修订", "en": "DailyMed updated 20 Feb 2024; prescribing information revised Feb 2024" }, "dosageForm": { "zh": "左甲状腺素钠口服片", "en": "levothyroxine sodium oral tablet" }, "route": { "zh": "口服（仅作标签产品身份字段）", "en": "oral (label product-identity field only)" }, "routeCodes": [ "oral" ], "productCode": "NDC 0074-6624-11", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片 100 mcg（0.1 mg）；100 片纸盒（单位剂量包装）", "en": "100 mcg (0.1 mg) per tablet; 100-tablet carton (unit-dose package)" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=1e11ad30-1041-4520-10b0-8f9d30d30fcc&name=synthroid-spl-03.jpg", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "左甲状腺素钠", "en": "levothyroxine sodium" }, "value": 100, "unit": "mcg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人服用片数、调量或换算指令", "en": "labelled amount per tablet; not an individual tablet count, adjustment or conversion instruction" } } ], "concentration": null, "container": { "typeCode": "unit_dose_carton", "typeLabel": { "zh": "单位剂量纸盒", "en": "unit-dose carton" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "片/盒", "en": "tablets per carton" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-21", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "片/单位剂量纸盒", "en": "tablets per unit-dose carton" } }, "physicalClues": { "color": { "zh": "黄色", "en": "yellow" }, "shape": { "zh": "圆形片", "en": "round tablet" }, "imprint": "SYNTHROID / 100", "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_9fe75faad23655ce", "label": "DailyMed（NLM）：SYNTHROID 左甲状腺素钠美国公开标签（AbbVie；2024-02 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=1e11ad30-1041-4520-10b0-8f9d30d30fcc", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-synthroid-levothyroxine-tablet-112mcg-0074929619", "marketCode": "US", "labelVersion": { "zh": "DailyMed 页面 2024-02-20 更新；处方信息 2024-02 修订", "en": "DailyMed updated 20 Feb 2024; prescribing information revised Feb 2024" }, "dosageForm": { "zh": "左甲状腺素钠口服片", "en": "levothyroxine sodium oral tablet" }, "route": { "zh": "口服（仅作标签产品身份字段）", "en": "oral (label product-identity field only)" }, "routeCodes": [ "oral" ], "productCode": "NDC 0074-9296-19", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片 112 mcg（0.112 mg）；1000 片瓶装", "en": "112 mcg (0.112 mg) per tablet; 1000-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=1e11ad30-1041-4520-10b0-8f9d30d30fcc&name=synthroid-spl-0d.jpg", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "左甲状腺素钠", "en": "levothyroxine sodium" }, "value": 112, "unit": "mcg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人服用片数、调量或换算指令", "en": "labelled amount per tablet; not an individual tablet count, adjustment or conversion instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "原瓶", "en": "bottle" }, "fill": null, "countPerPackage": 1000, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-21", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 1000, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "玫瑰色", "en": "rose" }, "shape": { "zh": "圆形片", "en": "round tablet" }, "imprint": "SYNTHROID / 112", "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_9fe75faad23655ce", "label": "DailyMed（NLM）：SYNTHROID 左甲状腺素钠美国公开标签（AbbVie；2024-02 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=1e11ad30-1041-4520-10b0-8f9d30d30fcc", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-synthroid-levothyroxine-tablet-125mcg-0074706819", "marketCode": "US", "labelVersion": { "zh": "DailyMed 页面 2024-02-20 更新；处方信息 2024-02 修订", "en": "DailyMed updated 20 Feb 2024; prescribing information revised Feb 2024" }, "dosageForm": { "zh": "左甲状腺素钠口服片", "en": "levothyroxine sodium oral tablet" }, "route": { "zh": "口服（仅作标签产品身份字段）", "en": "oral (label product-identity field only)" }, "routeCodes": [ "oral" ], "productCode": "NDC 0074-7068-19", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片 125 mcg（0.125 mg）；1000 片瓶装", "en": "125 mcg (0.125 mg) per tablet; 1000-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=1e11ad30-1041-4520-10b0-8f9d30d30fcc&name=synthroid-spl-09.jpg", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "左甲状腺素钠", "en": "levothyroxine sodium" }, "value": 125, "unit": "mcg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人服用片数、调量或换算指令", "en": "labelled amount per tablet; not an individual tablet count, adjustment or conversion instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "原瓶", "en": "bottle" }, "fill": null, "countPerPackage": 1000, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-21", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 1000, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "棕色", "en": "brown" }, "shape": { "zh": "圆形片", "en": "round tablet" }, "imprint": "SYNTHROID / 125", "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_9fe75faad23655ce", "label": "DailyMed（NLM）：SYNTHROID 左甲状腺素钠美国公开标签（AbbVie；2024-02 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=1e11ad30-1041-4520-10b0-8f9d30d30fcc", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-synthroid-levothyroxine-tablet-137mcg-0074372790", "marketCode": "US", "labelVersion": { "zh": "DailyMed 页面 2024-02-20 更新；处方信息 2024-02 修订", "en": "DailyMed updated 20 Feb 2024; prescribing information revised Feb 2024" }, "dosageForm": { "zh": "左甲状腺素钠口服片", "en": "levothyroxine sodium oral tablet" }, "route": { "zh": "口服（仅作标签产品身份字段）", "en": "oral (label product-identity field only)" }, "routeCodes": [ "oral" ], "productCode": "NDC 0074-3727-90", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片 137 mcg（0.137 mg）；90 片瓶装", "en": "137 mcg (0.137 mg) per tablet; 90-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=1e11ad30-1041-4520-10b0-8f9d30d30fcc&name=synthroid-spl-05.jpg", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "左甲状腺素钠", "en": "levothyroxine sodium" }, "value": 137, "unit": "mcg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人服用片数、调量或换算指令", "en": "labelled amount per tablet; not an individual tablet count, adjustment or conversion instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "原瓶", "en": "bottle" }, "fill": null, "countPerPackage": 90, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-21", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 90, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "青绿色", "en": "turquoise" }, "shape": { "zh": "圆形片", "en": "round tablet" }, "imprint": "SYNTHROID / 137", "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_9fe75faad23655ce", "label": "DailyMed（NLM）：SYNTHROID 左甲状腺素钠美国公开标签（AbbVie；2024-02 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=1e11ad30-1041-4520-10b0-8f9d30d30fcc", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-synthroid-levothyroxine-tablet-150mcg-0074706990", "marketCode": "US", "labelVersion": { "zh": "DailyMed 页面 2024-02-20 更新；处方信息 2024-02 修订", "en": "DailyMed updated 20 Feb 2024; prescribing information revised Feb 2024" }, "dosageForm": { "zh": "左甲状腺素钠口服片", "en": "levothyroxine sodium oral tablet" }, "route": { "zh": "口服（仅作标签产品身份字段）", "en": "oral (label product-identity field only)" }, "routeCodes": [ "oral" ], "productCode": "NDC 0074-7069-90", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片 150 mcg（0.15 mg）；90 片瓶装", "en": "150 mcg (0.15 mg) per tablet; 90-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=1e11ad30-1041-4520-10b0-8f9d30d30fcc&name=synthroid-spl-0a.jpg", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "左甲状腺素钠", "en": "levothyroxine sodium" }, "value": 150, "unit": "mcg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人服用片数、调量或换算指令", "en": "labelled amount per tablet; not an individual tablet count, adjustment or conversion instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "原瓶", "en": "bottle" }, "fill": null, "countPerPackage": 90, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-21", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 90, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "蓝色", "en": "blue" }, "shape": { "zh": "圆形片", "en": "round tablet" }, "imprint": "SYNTHROID / 150", "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_9fe75faad23655ce", "label": "DailyMed（NLM）：SYNTHROID 左甲状腺素钠美国公开标签（AbbVie；2024-02 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=1e11ad30-1041-4520-10b0-8f9d30d30fcc", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-synthroid-levothyroxine-tablet-175mcg-0074707019", "marketCode": "US", "labelVersion": { "zh": "DailyMed 页面 2024-02-20 更新；处方信息 2024-02 修订", "en": "DailyMed updated 20 Feb 2024; prescribing information revised Feb 2024" }, "dosageForm": { "zh": "左甲状腺素钠口服片", "en": "levothyroxine sodium oral tablet" }, "route": { "zh": "口服（仅作标签产品身份字段）", "en": "oral (label product-identity field only)" }, "routeCodes": [ "oral" ], "productCode": "NDC 0074-7070-19", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片 175 mcg（0.175 mg）；1000 片瓶装", "en": "175 mcg (0.175 mg) per tablet; 1000-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=1e11ad30-1041-4520-10b0-8f9d30d30fcc&name=synthroid-spl-0b.jpg", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "左甲状腺素钠", "en": "levothyroxine sodium" }, "value": 175, "unit": "mcg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人服用片数、调量或换算指令", "en": "labelled amount per tablet; not an individual tablet count, adjustment or conversion instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "原瓶", "en": "bottle" }, "fill": null, "countPerPackage": 1000, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-21", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 1000, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "淡紫色", "en": "lilac" }, "shape": { "zh": "圆形片", "en": "round tablet" }, "imprint": "SYNTHROID / 175", "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_9fe75faad23655ce", "label": "DailyMed（NLM）：SYNTHROID 左甲状腺素钠美国公开标签（AbbVie；2024-02 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=1e11ad30-1041-4520-10b0-8f9d30d30fcc", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-synthroid-levothyroxine-tablet-200mcg-0074714811", "marketCode": "US", "labelVersion": { "zh": "DailyMed 页面 2024-02-20 更新；处方信息 2024-02 修订", "en": "DailyMed updated 20 Feb 2024; prescribing information revised Feb 2024" }, "dosageForm": { "zh": "左甲状腺素钠口服片", "en": "levothyroxine sodium oral tablet" }, "route": { "zh": "口服（仅作标签产品身份字段）", "en": "oral (label product-identity field only)" }, "routeCodes": [ "oral" ], "productCode": "NDC 0074-7148-11", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片 200 mcg（0.2 mg）；100 片纸盒（单位剂量包装）", "en": "200 mcg (0.2 mg) per tablet; 100-tablet carton (unit-dose package)" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=1e11ad30-1041-4520-10b0-8f9d30d30fcc&name=synthroid-spl-04.jpg", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "左甲状腺素钠", "en": "levothyroxine sodium" }, "value": 200, "unit": "mcg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人服用片数、调量或换算指令", "en": "labelled amount per tablet; not an individual tablet count, adjustment or conversion instruction" } } ], "concentration": null, "container": { "typeCode": "unit_dose_carton", "typeLabel": { "zh": "单位剂量纸盒", "en": "unit-dose carton" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "片/盒", "en": "tablets per carton" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-21", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "片/单位剂量纸盒", "en": "tablets per unit-dose carton" } }, "physicalClues": { "color": { "zh": "粉色", "en": "pink" }, "shape": { "zh": "圆形片", "en": "round tablet" }, "imprint": "SYNTHROID / 200", "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_9fe75faad23655ce", "label": "DailyMed（NLM）：SYNTHROID 左甲状腺素钠美国公开标签（AbbVie；2024-02 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=1e11ad30-1041-4520-10b0-8f9d30d30fcc", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-synthroid-levothyroxine-tablet-300mcg-0074714990", "marketCode": "US", "labelVersion": { "zh": "DailyMed 页面 2024-02-20 更新；处方信息 2024-02 修订", "en": "DailyMed updated 20 Feb 2024; prescribing information revised Feb 2024" }, "dosageForm": { "zh": "左甲状腺素钠口服片", "en": "levothyroxine sodium oral tablet" }, "route": { "zh": "口服（仅作标签产品身份字段）", "en": "oral (label product-identity field only)" }, "routeCodes": [ "oral" ], "productCode": "NDC 0074-7149-90", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片 300 mcg（0.3 mg）；90 片瓶装", "en": "300 mcg (0.3 mg) per tablet; 90-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=1e11ad30-1041-4520-10b0-8f9d30d30fcc&name=synthroid-spl-0c.jpg", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "左甲状腺素钠", "en": "levothyroxine sodium" }, "value": 300, "unit": "mcg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人服用片数、调量或换算指令", "en": "labelled amount per tablet; not an individual tablet count, adjustment or conversion instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "原瓶", "en": "bottle" }, "fill": null, "countPerPackage": 90, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-21", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 90, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "绿色", "en": "green" }, "shape": { "zh": "圆形片", "en": "round tablet" }, "imprint": "SYNTHROID / 300", "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_9fe75faad23655ce", "label": "DailyMed（NLM）：SYNTHROID 左甲状腺素钠美国公开标签（AbbVie；2024-02 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=1e11ad30-1041-4520-10b0-8f9d30d30fcc", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-synthroid-levothyroxine-tablet-50mcg-0074455211", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=synthroid-spl-02.jpg&setid=1e11ad30-1041-4520-10b0-8f9d30d30fcc&type=img", "alt": "SYNTHROID 50 mcg（0.05 mg）左甲状腺素钠片、NDC 0074-4552-11、100 片单位剂量纸盒在美国 DailyMed 公开标签中的展开图", "archiveMarket": "美国", "labelVersion": "2024-02", "presentation": "SYNTHROID 50 mcg（0.05 mg）、NDC 0074-4552-11、100 片单位剂量纸盒展开图（DailyMed 2024-02 美国公开标签）。", "notice": "此图只对应美国 DailyMed 公开标签中的 SYNTHROID 50 mcg（0.05 mg）、NDC 0074-4552-11、100 片单位剂量纸盒。它只帮助核对品牌、通用名、每片标示量、包装数量与来源；不用于鉴定真伪，也不证明其他强度、其他包装、其他市场标签、原研身份、目标市场批准、可售资格，或任何个人该吃几片、能否对半、调量或换算。", "source": { "id": "src_9fe75faad23655ce", "label": "DailyMed（NLM）：SYNTHROID 左甲状腺素钠美国公开标签（AbbVie；2024-02 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=1e11ad30-1041-4520-10b0-8f9d30d30fcc", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "SYNTHROID 说明书放大阅读：mcg 与 mg 相差一千倍，不能凭感觉换算", "en": "SYNTHROID label reading: mcg and mg differ by a thousand-fold and are not converted by feeling" }, "summary": { "zh": "本模块以 FDA 2020 美国标签为阅读入口，帮助核对 SYNTHROID、左甲状腺素、每片标示的微克（mcg）强度和目标市场；它不提供个人片数、补服、调量或与另一种甲状腺激素产品转换的方案。", "en": "This module uses the 2020 U.S. FDA label as a reading entry point. It helps check SYNTHROID, levothyroxine, the microgram (mcg) strength per tablet and target market; it does not provide an individual tablet count, make-up use, adjustment or conversion to another thyroid-hormone product." }, "checks": [ { "zh": "先核对 SYNTHROID、左甲状腺素、每片标示的 mcg、实际包装和目标市场。mcg（微克）与 mg（毫克）是不同单位，1 mg 等于 1000 mcg；单位相近的写法不能用来凭经验换片数。", "en": "Check SYNTHROID, levothyroxine, the mcg strength per tablet, actual package and target market first. mcg (micrograms) and mg (milligrams) are different units: 1 mg equals 1,000 mcg. Similar-looking units must not be used to convert tablet count by experience." }, { "zh": "不同颜色、不同 mcg 强度、不同品牌或其他市场包装都属于不同产品身份线索。即使都写“甲状腺素”，也不表示可以把两种片剂自行等量替换、掰半拼凑或交替服用。", "en": "Different colours, mcg strengths, brands or market packs are different product-identity clues. Even when both say “thyroid hormone,” they do not establish self-equivalent substitution, split-and-combine use or alternation." }, { "zh": "标签涉及与食物、矿物质补充剂、抗酸药和多种药物的吸收相关问题。家中有钙、铁、胃药、降脂药、抗凝药或多种慢病药时，应带完整药单请药师或开方团队逐项核对。", "en": "The label addresses absorption-related issues with food, mineral supplements, antacids and multiple medicines. With calcium, iron, stomach medicines, lipid medicines, anticoagulants or multiple chronic-care products at home, bring the complete medicine list for pharmacist or prescribing-team review." }, { "zh": "疲劳、心悸、体重或睡眠变化不能由网页直接归因并自行调药。开始、减量、补服、转换或任何异常症状都应依据现行标签、化验与专业团队的具体判断。", "en": "Fatigue, palpitations, weight or sleep changes cannot be attributed by a webpage and used to self-adjust. Starting, tapering, make-up use, conversion or any concerning symptom needs the current label, testing and specific professional judgement." } ], "source": { "id": "src_6b43994eb7ece0a2", "label": "FDA：SYNTHROID 2020 美国处方信息（NDA 021402）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021402s034lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "左甲状腺素怎样起作用：它提供合成的 T4 激素", "en": "How levothyroxine works: it provides synthetic T4 hormone" }, "summary": { "zh": "FDA 标签将左甲状腺素描述为合成的 T4（四碘甲状腺原氨酸），其生理作用由甲状腺激素受体介导。机制帮助解释为何单位、产品身份和实验室随访不能随意替换；它不判断个人甲状腺状态、剂量或化验目标。", "en": "The FDA label describes levothyroxine as synthetic T4 (tetraiodothyronine), with physiologic action mediated through thyroid-hormone receptors. This helps explain why units, product identity and laboratory follow-up cannot be freely substituted; it does not determine an individual thyroid state, dose or test target." }, "checks": [ { "zh": "T4 机制不让 mcg 与 mg、不同强度、不同品牌或不同市场产品可自行换算。每一片的单位、产品和处方都必须作为完整信息核对。", "en": "A T4 mechanism does not make mcg and mg, different strengths, brands or market products self-convertible. Each tablet’s unit, product and prescription must be checked as complete information." }, { "zh": "机制不能解释所有疲劳、心悸、体重或睡眠变化，也不能成为自行加减药的依据。症状、化验、其他疾病和完整药单都需要由专业人员综合评估。", "en": "Mechanism cannot explain every fatigue, palpitation, weight or sleep change, nor justify self-adjustment. Symptoms, tests, other conditions and the complete medicine list need integrated professional assessment." }, { "zh": "食物、矿物质补充剂和其他药物可能影响实际吸收或评估；这类相互作用必须回到准确产品的现行标签和药师/开方团队，而不是从机制词汇自行排时间表。", "en": "Food, mineral supplements and other medicines may affect real absorption or assessment; these interactions must return to the current label for the exact product and a pharmacist/prescribing team, not a self-made schedule from mechanism terms." } ], "source": { "id": "src_6b43994eb7ece0a2", "label": "FDA：SYNTHROID 2020 美国处方信息（临床药理）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021402s034lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "Synthroid", "generic": "左甲状腺素", "dosageFormClass": "左甲状腺素钠口服片：25、50、75、88、100、112、125、137、150、175、200、300 mcg（本档案分别展示 12 个美国标签包装面板）" }, "labelSource": { "id": "src_9fe75faad23655ce", "label": "DailyMed（NLM）：SYNTHROID 左甲状腺素钠美国公开标签（AbbVie；2024-02 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=1e11ad30-1041-4520-10b0-8f9d30d30fcc", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "productRoutes": [ { "source": { "id": "src_9fe75faad23655ce", "label": "DailyMed（NLM）：SYNTHROID 左甲状腺素钠美国公开标签（AbbVie；2024-02 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=1e11ad30-1041-4520-10b0-8f9d30d30fcc", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_6b43994eb7ece0a2", "label": "FDA：SYNTHROID 2020 美国标签档案（NDA 021402）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021402s034lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "美国 DailyMed 的 SYNTHROID（levothyroxine sodium）2024-02 公开标签列示 12 种每片微克（mcg）标示量。本页将每种强度与准确 NDC、包装面板及来源分别对应；“mcg／mg”是产品身份单位，不是个人该吃几片、能否对半、加减、补服、换药或换算的答案。", "history": "甲状腺激素产品的具体品牌、强度、剂型、包装、市场和现行标签需逐项核验。相同通用名、相近数字或都写“甲状腺素”不能证明可自行替代、交替、叠加或按毫克数换算；历史资料不构成个人用药、剂量、替代或购买建议。", "sourceDocuments": [ { "id": "src_9fe75faad23655ce", "label": "DailyMed（NLM）：SYNTHROID 左甲状腺素钠美国公开标签（AbbVie；2024-02 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=1e11ad30-1041-4520-10b0-8f9d30d30fcc", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_6b43994eb7ece0a2", "label": "FDA：SYNTHROID 2020 美国标签档案（NDA 021402）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021402s034lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_5ed30b676fbb9773", "label": "FDA Drugs@FDA 官方检索入口", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_lookup_entry", "documentKind": "regulatory_lookup", "market": "US", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } ], "applicationNumber": "NDA 021402", "approvalTimeline": [ { "date": "2002", "title": { "zh": "FDA 标签所列美国初始批准年份", "en": "Initial U.S. approval year listed in the FDA label" }, "detail": { "zh": "本页链接的 FDA 标签档案列示 Initial U.S. Approval: 2002。该历史定位不等同于当前批准、可得性、持有人或其他市场状态。", "en": "The FDA label archive linked here lists Initial U.S. Approval: 2002. This historical locator is not a conclusion about current approval, availability, holder or another market." }, "source": { "id": "src_6b43994eb7ece0a2", "label": "FDA: SYNTHROID label archive", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021402s034lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, { "date": "2020", "title": { "zh": "FDA 标签档案版本", "en": "FDA label archive version" }, "detail": { "zh": "本页链接 2020 的 FDA 标签档案作为可复核阅读入口。现行标签、规格、适应症和安全信息必须另行以目标市场当前文件核对。", "en": "This page links the 2020 FDA label archive as a traceable reading entry point. Current labeling, strength, indication and safety information require separate verification against the target market’s current document." }, "source": { "id": "src_6b43994eb7ece0a2", "label": "FDA: SYNTHROID label archive", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021402s034lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "已链接公开标签档案", "en": "Public label archive linked" }, "detail": { "zh": "仅对应本页所列 FDA 文件。", "en": "Only the FDA document listed on this page is linked." } }, { "market": { "zh": "中国大陆、欧盟、日本", "en": "Mainland China, EU, Japan" }, "status": { "zh": "待逐项建立市场记录", "en": "Market record not established" }, "detail": { "zh": "不从美国标签档案推定当地批准、持有人、规格、供应或可售资格。", "en": "No local approval, holder, strength, supply or sale-eligibility conclusion is inferred from the U.S. label archive." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "标签档案能代表现在的产品信息吗？", "en": "Does a label archive represent current product information?" }, "answer": { "zh": "不能自动代表。档案用于定位来源；需要以目标市场的现行官方标签逐项复核。", "en": "Not automatically. The archive locates a source; each point needs verification against the target market’s current official label." } }, { "question": { "zh": "为什么这里不展示价格或原研/仿制结论？", "en": "Why are price and originator/generic conclusions not shown?" }, "answer": { "zh": "这些结论需要产品、剂型、规格、包装、市场、日期和原始记录分别齐全并经人工审核；单一标签文件不足以支持。", "en": "Those conclusions require separately complete and human-reviewed product, dosage-form, strength, pack, market, date and primary-record fields; one label file is insufficient." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "how-to-read-a-drug-label", "regulatory-sources-first" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/synthroid/", "en": "https://origindrug.com/en/drugs/synthroid/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "euthyrox", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-23", "status": "published_traceable_archive" }, "names": { "brand": "EUTHYROX", "generic": "左甲状腺素钠", "aliases": [ "EUTHYROX", "优甲乐", "左甲状腺素钠", "levothyroxine", "levothyroxine sodium" ], "marketBrandNames": [ { "name": "优甲乐®", "market": { "zh": "中国大陆", "en": "Mainland China" }, "evidenceStatus": "historical_public_record", "note": { "zh": "Merck China 产品页将优甲乐®标为左甲状腺素钠片，并介绍 2020 年新配方上市及新旧配方过渡背景。它只是名称与配方历史线索；不证明当前批准、准确规格/包装、供应、销售资格或与美国 EUTHYROX、SYNTHROID 或其他左甲状腺素产品可替代。", "en": "The Merck China product page identifies EUTHYROX® as levothyroxine sodium tablets and describes a 2020 new-formulation launch and transition. It is only a name and formulation-history clue; it does not establish current approval, an exact strength/package, supply, sale eligibility or interchangeability with U.S. EUTHYROX, SYNTHROID or another levothyroxine product." }, "source": { "id": "src_6023323aa4ec2936", "label": "默克中国：优甲乐® 左甲状腺素钠片页面（2020 年新配方上市历史）", "url": "https://www.merckgroup.com.cn/cn-zh/expertise/general-medicine/general-medicine-treatments/euthyrox.html/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "first_party_product_page", "market": "CN", "accessStatus": "public_access_with_site_controls", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } } ], "mainlandChinaTradeNameCue": { "value": "优甲乐®", "status": "discovery_cue_requires_target_market_verification", "source": { "id": "src_6023323aa4ec2936", "label": "默克中国：优甲乐® 左甲状腺素钠片页面（2020 年新配方上市历史）", "url": "https://www.merckgroup.com.cn/cn-zh/expertise/general-medicine/general-medicine-treatments/euthyrox.html/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "first_party_product_page", "market": "CN", "accessStatus": "public_access_with_site_controls", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } } }, "identity": { "therapeuticArea": "代谢", "sourceArchiveMarket": "美国：DailyMed 的 EUTHYROX 当前公开标签（SPL v10，2026-01-27 生效；处方信息 2025-12 修订）。中国大陆：Merck China 页面提供“优甲乐®／左甲状腺素钠片”名称及 2020 年新配方上市历史线索；不以该页建立当前批准、具体包装、供应、销售资格或跨市场可替代性结论。", "dosageFormClass": "美国当前公开标签：左甲状腺素钠口服片 25、50、75、88、100、112、125、137、150、175、200 mcg；本档案精确展示 50 mcg（0.05 mg）、NDC 72305-050-30、30 片泡罩板纸盒。", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "2002（DailyMed 美国公开标签所列 Initial U.S. Approval）", "archiveSponsorText": "Provell Pharmaceuticals, LLC / DailyMed 当前美国公开标签；Merck China 优甲乐名称与配方历史页面" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [ "SYNTHROID", "liothyronine", "甲状腺片", "左甲状腺素口服溶液" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-euthyrox-levothyroxine-sodium-tablet-50mcg-30carton-ndc-72305-050-30", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（SPL v10，2026-01-27 生效；处方信息 2025-12 修订）", "en": "Current U.S. DailyMed public label (SPL v10, effective 27 Jan 2026; prescribing information revised Dec 2025)" }, "dosageForm": { "zh": "左甲状腺素钠口服片", "en": "levothyroxine sodium oral tablet" }, "route": { "zh": "口服（标签产品身份字段）", "en": "oral (label product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 72305-050-30", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片 50 mcg（0.05 mg）；30 片泡罩板纸盒（美国标签）", "en": "50 mcg (0.05 mg) per tablet; 30-tablet blister-pack carton (U.S. label)" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=50mcgbox.jpg&setid=bc3c6830-ba68-4ba3-9896-a12d0ad0b275&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "左甲状腺素钠", "en": "levothyroxine sodium" }, "value": 50, "unit": "mcg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、调量或换算指令", "en": "labelled amount per tablet; not an individual's tablet count, adjustment or conversion instruction" } } ], "concentration": null, "container": { "typeCode": "blister_carton", "typeLabel": { "zh": "泡罩板纸盒", "en": "blister-pack carton" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "片/盒", "en": "tablets per carton" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-23", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 30, "unit": { "zh": "片/盒", "en": "tablets per carton" } }, "physicalClues": { "color": { "zh": "白色", "en": "white" }, "shape": { "zh": "圆形片", "en": "round tablet" }, "imprint": "EM / 50", "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_189d3229b8a1bba5", "label": "DailyMed（NLM）：EUTHYROX 左甲状腺素钠当前美国公开标签（Provell Pharmaceuticals；SPL v10，2026-01-27 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=bc3c6830-ba68-4ba3-9896-a12d0ad0b275", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-euthyrox-levothyroxine-sodium-tablet-50mcg-30carton-ndc-72305-050-30", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=50mcgbox.jpg&setid=bc3c6830-ba68-4ba3-9896-a12d0ad0b275&type=img", "alt": "EUTHYROX 左甲状腺素钠 50 mcg（0.05 mg）、NDC 72305-050-30、30 片泡罩板纸盒在美国 DailyMed 当前公开标签中的包装图", "archiveMarket": "美国", "labelVersion": "DailyMed SPL v10（2026-01-27 生效；处方信息 2025-12 修订）", "presentation": "EUTHYROX 左甲状腺素钠：每片 50 mcg（0.05 mg），NDC 72305-050-30，30 片泡罩板纸盒（美国标签）。", "notice": "此图只对应美国 DailyMed 当前公开标签中的 EUTHYROX、左甲状腺素钠 50 mcg（0.05 mg）、NDC 72305-050-30 和 30 片泡罩板纸盒。它只帮助核对品牌、通用名、每片标示量、包装和来源；不用于鉴定真伪，也不代表优甲乐中国包装、SYNTHROID、其他规格/包装、其他市场、当前可得性、原研身份、可替代性或任何个人的片数、调量、停用、换药或购买方案。", "source": { "id": "src_189d3229b8a1bba5", "label": "DailyMed（NLM）：EUTHYROX 左甲状腺素钠当前美国公开标签（Provell Pharmaceuticals；SPL v10，2026-01-27 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=bc3c6830-ba68-4ba3-9896-a12d0ad0b275", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "EUTHYROX／优甲乐说明书放大阅读：mcg、品牌与市场要一起看", "en": "EUTHYROX / EUTHYROX China label reading: mcg, brand and market must be checked together" }, "summary": { "zh": "本模块用 DailyMed 的美国 EUTHYROX 公开标签与 Merck China 的优甲乐名称/配方历史页面，帮助读者核对准确产品身份；它不提供任何人的片数、间隔、补用、调量、替代、联用或停药方案。", "en": "This module uses the U.S. DailyMed EUTHYROX public label and the Merck China EUTHYROX name/formulation-history page to check exact product identity; it does not provide anyone's tablet count, interval, make-up use, adjustment, substitution, combination or stopping plan." }, "checks": [ { "zh": "50 mcg 等于 0.05 mg；它是每片产品身份的单位换算，不是每天该吃几片、能否对半或如何调量的答案。应同时核对品牌、通用名、每片标示量、剂型、包装、目标市场和现行处方。", "en": "50 mcg equals 0.05 mg. This is a unit conversion for one tablet's identity, not an answer to daily tablet count, splitting or adjustment. Check the brand, generic name, labelled amount per tablet, form, package, target market and current prescription together." }, { "zh": "同为左甲状腺素、名称相近或数字相近，不使 EUTHYROX、优甲乐、SYNTHROID 或另一种甲状腺激素产品可以自行替换、交替、叠加或按片数换算。不同市场的标签和包装必须单独核对。", "en": "A shared levothyroxine ingredient, similar name or similar number does not make EUTHYROX, EUTHYROX China, SYNTHROID or another thyroid-hormone product self-substitutable, alternatable, combinable or convertible by tablet count. Labels and packages in different markets must be checked separately." }, { "zh": "美国标签有与食物、含钙/铁产品、抗酸药及其他药物相互作用相关的文字。实际服用时间或如何与其他药错开，必须依据准确产品的现行标签和开方团队/药师的个体化建议；网页不生成时间表。", "en": "The U.S. label includes language about food, calcium/iron-containing products, antacids and other medicine interactions. Actual timing or separation from another medicine must follow the current label for the exact product and individual advice from the prescribing team/pharmacist; this page does not generate a schedule." }, { "zh": "该美国标签含有“不得用于减重或肥胖治疗”的加框警告。任何心悸、胸痛、明显不适、用药清单变化或担心不良反应的问题，应联系当地医疗支持；不要据网页自行加量、补用、骤停或换成另一种产品。", "en": "The U.S. label carries a boxed warning that it is not for weight loss or obesity treatment. With palpitations, chest pain, marked symptoms, a changed medicine list or an adverse-effect concern, contact local medical support; do not self-increase, make up, abruptly stop or change product from this page." } ], "source": { "id": "src_189d3229b8a1bba5", "label": "DailyMed（NLM）：EUTHYROX 左甲状腺素钠当前美国公开标签（Provell Pharmaceuticals；SPL v10，2026-01-27 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=bc3c6830-ba68-4ba3-9896-a12d0ad0b275", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "左甲状腺素钠怎样起作用：标签药理不能替代个人甲状腺方案", "en": "How levothyroxine sodium works: label pharmacology cannot replace an individual thyroid plan" }, "summary": { "zh": "美国公开标签将左甲状腺素钠描述为合成 T4。它帮助理解通用名、产品身份与安全边界，不用来判断任何人的疾病原因、化验目标、片数、调量、换药或联用方案。", "en": "The U.S. public label describes levothyroxine sodium as synthetic T4. It helps explain the generic name, product identity and safety boundaries; it is not used to decide anyone's disease cause, laboratory target, tablet count, adjustment, switching or combination plan." }, "checks": [ { "zh": "“合成 T4”不是自我诊断、判断化验结果或自行增减药物的依据。症状和检查结果须由开方团队结合准确产品、既往病史和完整药单解释。", "en": "“Synthetic T4” is not a basis for self-diagnosis, interpreting laboratory results or changing a medicine independently. Symptoms and test results require interpretation by the prescribing team with the exact product, history and complete medicine list." }, { "zh": "共同通用名或共同机制不建立 EUTHYROX、优甲乐、SYNTHROID 或其他甲状腺相关产品之间的个人换算或可替代性；品牌、强度、剂型、市场和标签版本都是产品身份的一部分。", "en": "A shared generic name or mechanism does not establish personal conversion or interchangeability between EUTHYROX, EUTHYROX China, SYNTHROID or another thyroid-related product; brand, strength, form, market and label version are all part of product identity." }, { "zh": "不把机制页面用于处理急性胸痛、严重心悸、晕厥、显著呼吸困难或其他急性不适。遇到急性或严重问题，应优先使用当地紧急医疗支持，而不是试验不同品牌、强度或服用方式。", "en": "Do not use a mechanism page to manage acute chest pain, severe palpitations, fainting, marked breathing difficulty or another acute concern. With an acute or serious problem, prioritise local urgent medical support rather than experimenting with brand, strength or administration method." } ], "source": { "id": "src_189d3229b8a1bba5", "label": "DailyMed（NLM）：EUTHYROX 左甲状腺素钠当前美国公开标签（Provell Pharmaceuticals；SPL v10，2026-01-27 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=bc3c6830-ba68-4ba3-9896-a12d0ad0b275", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "EUTHYROX", "generic": "左甲状腺素钠", "dosageFormClass": "美国当前公开标签：左甲状腺素钠口服片 25、50、75、88、100、112、125、137、150、175、200 mcg；本档案精确展示 50 mcg（0.05 mg）、NDC 72305-050-30、30 片泡罩板纸盒。" }, "labelSource": { "id": "src_189d3229b8a1bba5", "label": "DailyMed（NLM）：EUTHYROX 左甲状腺素钠当前美国公开标签（Provell Pharmaceuticals；SPL v10，2026-01-27 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=bc3c6830-ba68-4ba3-9896-a12d0ad0b275", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "productRoutes": [ { "source": { "id": "src_189d3229b8a1bba5", "label": "DailyMed（NLM）：EUTHYROX 左甲状腺素钠当前美国公开标签（Provell Pharmaceuticals；SPL v10，2026-01-27 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=bc3c6830-ba68-4ba3-9896-a12d0ad0b275", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-23", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-23", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "EUTHYROX 与优甲乐是公开来源中可检索到的左甲状腺素钠品牌/名称线索。页面将“每片 50 mcg（0.05 mg）”、准确美国 NDC、30 片泡罩板纸盒和来源逐项对应；mcg 与 mg 是产品身份单位，不是个人片数、调整、补用、换药、与其他甲状腺产品互换或购买的答案。", "history": "Merck China 页面记载优甲乐在中国的 2020 年新配方上市及新旧配方过渡背景；该历史不能被外推为任何当前包装、当前批准、现行用药规则或替代结论。即使通用名相同，品牌、强度、剂型、包装、市场和标签版本不同也必须按实际产品与目标市场的现行资料逐项核对。", "sourceDocuments": [ { "id": "src_189d3229b8a1bba5", "label": "DailyMed（NLM）：EUTHYROX 左甲状腺素钠当前美国公开标签（Provell Pharmaceuticals；SPL v10，2026-01-27 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=bc3c6830-ba68-4ba3-9896-a12d0ad0b275", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, { "id": "src_6023323aa4ec2936", "label": "默克中国：优甲乐® 左甲状腺素钠片页面（2020 年新配方上市历史）", "url": "https://www.merckgroup.com.cn/cn-zh/expertise/general-medicine/general-medicine-treatments/euthyrox.html/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "first_party_product_page", "market": "CN", "accessStatus": "public_access_with_site_controls", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } ], "applicationNumber": "DailyMed SPL setid bc3c6830-ba68-4ba3-9896-a12d0ad0b275（美国公开标签；本档案不据此推定中国或其他市场状态）", "approvalTimeline": [ { "date": "2002", "title": { "zh": "美国公开标签所列初始批准年份", "en": "Initial U.S. approval year listed in the public label" }, "detail": { "zh": "DailyMed 的 EUTHYROX 美国公开标签列示 Initial U.S. Approval: 2002。该年份只定位此美国标签历史，不建立中国大陆或其他市场的批准、供应、可售资格、原研/仿制关系、可替代性或个人适用性。", "en": "The U.S. DailyMed public label for EUTHYROX lists Initial U.S. Approval: 2002. This year only locates this U.S. label history; it does not establish approval, supply, sale eligibility, originator/generic relationship, interchangeability or individual suitability in Mainland China or another market." }, "source": { "id": "src_189d3229b8a1bba5", "label": "DailyMed（NLM）：EUTHYROX 左甲状腺素钠当前美国公开标签（Provell Pharmaceuticals；SPL v10，2026-01-27 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=bc3c6830-ba68-4ba3-9896-a12d0ad0b275", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" } }, { "date": "2020-03", "title": { "zh": "优甲乐中国新配方上市历史", "en": "EUTHYROX China new-formulation launch history" }, "detail": { "zh": "Merck China 页面将优甲乐®列为左甲状腺素钠片，并说明中国于 2020 年 3 月末进入新配方上市历史。它只用于核对名称和配方过渡背景，不代表现行批准、准确包装、供应、销售资格或与美国 EUTHYROX、SYNTHROID 或其他产品可替代。", "en": "The Merck China page identifies EUTHYROX® as levothyroxine sodium tablets and describes a late-March 2020 China new-formulation launch. It is used only to check the name and formulation-transition context, not current approval, exact packaging, supply, sale eligibility or interchangeability with U.S. EUTHYROX, SYNTHROID or another product." }, "source": { "id": "src_6023323aa4ec2936", "label": "默克中国：优甲乐® 左甲状腺素钠片页面（2020 年新配方上市历史）", "url": "https://www.merckgroup.com.cn/cn-zh/expertise/general-medicine/general-medicine-treatments/euthyrox.html/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "first_party_product_page", "market": "CN", "accessStatus": "public_access_with_site_controls", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, { "date": "2026-01-27", "title": { "zh": "DailyMed 当前美国公开标签生效", "en": "Current U.S. DailyMed public label effective" }, "detail": { "zh": "本档案以 DailyMed SPL v10（2026-01-27 生效；处方信息 2025-12 修订）核对美国 EUTHYROX 50 mcg、NDC 72305-050-30、30 片泡罩板纸盒。它不建立实际在售、库存、购买、个人片数、调量或换药方案。", "en": "This dossier uses DailyMed SPL v10 (effective 27 Jan 2026; prescribing information revised Dec 2025) to check U.S. EUTHYROX 50 mcg, NDC 72305-050-30 and the 30-tablet blister-pack carton. It does not establish actual marketing, stock, purchase, individual tablet count, adjustment or switching." }, "source": { "id": "src_189d3229b8a1bba5", "label": "DailyMed（NLM）：EUTHYROX 左甲状腺素钠当前美国公开标签（Provell Pharmaceuticals；SPL v10，2026-01-27 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=bc3c6830-ba68-4ba3-9896-a12d0ad0b275", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "已链接当前公开标签与一个准确纸盒面板", "en": "Current public label and one exact carton panel linked" }, "detail": { "zh": "本页只展示 EUTHYROX 左甲状腺素钠 50 mcg（0.05 mg）、NDC 72305-050-30、30 片泡罩板纸盒。它不用于鉴定真伪，也不建立实际在售、库存、购买、个人片数、用药时间、调量、换药或可替代性。", "en": "This page displays only EUTHYROX levothyroxine sodium 50 mcg (0.05 mg), NDC 72305-050-30 and a 30-tablet blister-pack carton. It does not authenticate a product or establish actual marketing, stock, purchase, individual tablet count, timing, adjustment, switching or interchangeability." } }, { "market": { "zh": "中国大陆", "en": "Mainland China" }, "status": { "zh": "品牌名称与配方历史线索已链接；现行市场记录待逐项建立", "en": "Brand-name and formulation-history clue linked; current market record not established" }, "detail": { "zh": "Merck China 页面可核对优甲乐®／左甲状腺素钠片名称及 2020 年新配方过渡背景；不从该页面、美国标签、NDC、英文品牌或包装图推定中国现行批准、包装、供应、可售资格、原研/仿制关系或可替代性。", "en": "The Merck China page can be used to check the EUTHYROX® / levothyroxine sodium tablet name and its 2020 formulation-transition context. No current China approval, package, supply, sale eligibility, originator/generic relationship or interchangeability is inferred from that page, the U.S. label, NDC, English brand or package image." } }, { "market": { "zh": "其他市场", "en": "Other markets" }, "status": { "zh": "待逐项建立市场记录", "en": "Market record not established" }, "detail": { "zh": "不从美国或中国资料外推其他市场的商品名、批准、规格、供应、可售资格或可替代性；每个市场均需按当地现行监管资料单独核对。", "en": "No trade name, approval, strength, supply, sale eligibility or interchangeability in another market is inferred from the U.S. or China material; every market needs separate checking against current local regulatory material." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "50 mcg 与 0.05 mg 是不是两种规格？", "en": "Are 50 mcg and 0.05 mg two different strengths?" }, "answer": { "zh": "它们是同一每片标示量的单位换算。此事实只帮助核对药盒身份；不回答个人该吃几片、能否对半、如何调量或能否换成另一种产品。", "en": "They are unit expressions of the same labelled amount per tablet. This only helps check package identity; it does not answer tablet count, splitting, adjustment or whether another product can be substituted." } }, { "question": { "zh": "优甲乐与美国 EUTHYROX 能否按名称或 mcg 直接互换？", "en": "Can EUTHYROX China and U.S. EUTHYROX be directly exchanged by name or mcg?" }, "answer": { "zh": "不能。现有公开资料来自不同市场：美国页面是当前美国标签，中国页面是名称与配方历史线索。共同品牌、通用名或相近数字不建立个人换算或可替代性；请让药师或开方团队核对实际药盒、目标市场现行标签和完整药单。", "en": "No. The public materials are from different markets: the U.S. page is a current U.S. label, while the China page is a name/formulation-history clue. A shared brand, generic name or similar number does not create personal conversion or interchangeability; have a pharmacist or prescribing team check the actual pack, current target-market label and full medicine list." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "dosage-forms-are-part-of-medicine-identity", "how-to-read-a-drug-label" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/euthyrox/", "en": "https://origindrug.com/en/drugs/euthyrox/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "lantus", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-21", "status": "published_traceable_archive" }, "names": { "brand": "Lantus", "generic": "甘精胰岛素", "aliases": [ "来得时", "insulin glargine", "LANTUS SoloStar" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": { "value": "来得时®", "status": "discovery_cue_requires_target_market_verification", "source": { "id": "src_62724608c8ba22b4", "label": "Sanofi China：来得时®（甘精胰岛素）产品公开页", "url": "https://www.sanofi.cn/zh/your-health/products/insulin-glargine-injection", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "first_party_product_page", "market": "CN", "accessStatus": "public_access_with_site_controls", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } } }, "identity": { "therapeuticArea": "代谢", "sourceArchiveMarket": "美国当前公开标签；其他市场状态未在本页建立", "dosageFormClass": "皮下注射液；U-100 10 mL 多剂量小瓶与 3 mL SoloStar 单人使用预填充笔为不同包装/装置形式（当前美国公开标签所列）", "dosageFormClassCode": "subcutaneous_injection", "route": "皮下使用（具体使用由专业人员核对）", "routeCode": "subcutaneous", "historicalApprovalEntry": "2000（当前美国公开标签所列美国初始批准）", "archiveSponsorText": "DailyMed（NLM）当前美国公开标签；sanofi-aventis U.S. LLC" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [ "TOUJEO", "U-300", "300 units/mL" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-lantus-insulin-glargine-u100-10ml-vial-ndc-0088-2220-33", "marketCode": "US", "labelVersion": { "zh": "处方信息 2025-05 修订；DailyMed SPL v35 于 2025-07-02 发布", "en": "Prescribing information revised May 2025; DailyMed SPL v35 published 2 Jul 2025" }, "dosageForm": { "zh": "LANTUS 甘精胰岛素注射液", "en": "LANTUS insulin glargine injection" }, "route": { "zh": "皮下使用（标签范围；网页不决定个人注射单位或时间）", "en": "subcutaneous use (label scope; this page does not determine an individual's injection units or timing)" }, "routeCodes": [ "subcutaneous" ], "productCode": "NDC 0088-2220-33", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "concentration", "primaryDisplay": { "zh": "100 units/mL（U-100）；10 mL 多剂量小瓶；1 瓶/盒", "en": "100 units/mL (U-100); 10 mL multiple-dose vial; 1 vial per carton" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=d5e07a0c-7e14-4756-9152-9fea485d654a&name=d5e07a0c-7e14-4756-9152-9fea485d654a-35.jpg", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "甘精胰岛素", "en": "insulin glargine" }, "value": 100, "unit": "units/mL", "basisCode": "concentration", "basisLabel": { "zh": "标签浓度；不是个人注射单位、剂量或换药规则", "en": "labelled concentration; not an individual's injection units, dose or switching rule" } } ], "concentration": { "basisCode": "insulin_units_per_mL", "notation": "U-100", "numerator": { "value": 100, "unit": "units" }, "denominator": { "value": 1, "unit": "mL" }, "display": { "zh": "100 units/mL（U-100；标签浓度，不是个人注射量）", "en": "100 units/mL (U-100; labelled concentration, not an individual injection amount)" } }, "container": { "typeCode": "multi_dose_vial", "typeLabel": { "zh": "10 mL 多剂量小瓶；1 瓶/盒", "en": "10 mL multiple-dose vial; 1 vial per carton" }, "fill": { "value": 10, "unit": "mL" }, "countPerPackage": 1, "countUnit": { "zh": "瓶/盒", "en": "vial per carton" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-21", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 1, "unit": { "zh": "瓶/盒", "en": "vial per carton" } }, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_aa60b67009c9d9ac", "label": "DailyMed（NLM）：LANTUS 甘精胰岛素当前美国公开标签（sanofi-aventis U.S.；SPL v35，2025-07-02 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d5e07a0c-7e14-4756-9152-9fea485d654a", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-lantus-solostar-insulin-glargine-u100-3ml-pen-ndc-0088-2219-05", "marketCode": "US", "labelVersion": { "zh": "处方信息 2025-05 修订；DailyMed SPL v35 于 2025-07-02 发布", "en": "Prescribing information revised May 2025; DailyMed SPL v35 published 2 Jul 2025" }, "dosageForm": { "zh": "LANTUS 甘精胰岛素注射液", "en": "LANTUS insulin glargine injection" }, "route": { "zh": "皮下使用（标签范围；网页不决定个人注射单位或时间）", "en": "subcutaneous use (label scope; this page does not determine an individual's injection units or timing)" }, "routeCodes": [ "subcutaneous" ], "productCode": "NDC 0088-2219-05", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "concentration", "primaryDisplay": { "zh": "100 units/mL（U-100）；3 mL SoloStar 单人使用预填充笔；5 支/盒", "en": "100 units/mL (U-100); 3 mL SoloStar single-patient-use prefilled pen; 5 pens per carton" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=d5e07a0c-7e14-4756-9152-9fea485d654a&name=d5e07a0c-7e14-4756-9152-9fea485d654a-36.jpg", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "甘精胰岛素", "en": "insulin glargine" }, "value": 100, "unit": "units/mL", "basisCode": "concentration", "basisLabel": { "zh": "标签浓度；不是个人注射单位、剂量或换药规则", "en": "labelled concentration; not an individual's injection units, dose or switching rule" } } ], "concentration": { "basisCode": "insulin_units_per_mL", "notation": "U-100", "numerator": { "value": 100, "unit": "units" }, "denominator": { "value": 1, "unit": "mL" }, "display": { "zh": "100 units/mL（U-100；标签浓度，不是个人注射量）", "en": "100 units/mL (U-100; labelled concentration, not an individual injection amount)" } }, "container": { "typeCode": "prefilled_pen", "typeLabel": { "zh": "3 mL SoloStar 单人使用预填充笔；5 支/盒", "en": "3 mL SoloStar single-patient-use prefilled pen; 5 pens per carton" }, "fill": { "value": 3, "unit": "mL" }, "countPerPackage": 5, "countUnit": { "zh": "支/盒", "en": "pens per carton" } }, "deliveryDevice": { "typeCode": "solostar_prefilled_pen", "name": { "zh": "SoloStar", "en": "SoloStar" } }, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-21", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 5, "unit": { "zh": "支/盒", "en": "pens per carton" } }, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_aa60b67009c9d9ac", "label": "DailyMed（NLM）：LANTUS 甘精胰岛素当前美国公开标签（sanofi-aventis U.S.；SPL v35，2025-07-02 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d5e07a0c-7e14-4756-9152-9fea485d654a", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-lantus-solostar-insulin-glargine-u100-3ml-pen-ndc-0088-2219-05", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=d5e07a0c-7e14-4756-9152-9fea485d654a&name=d5e07a0c-7e14-4756-9152-9fea485d654a-36.jpg", "alt": "LANTUS SoloStar 甘精胰岛素在美国 DailyMed 当前标签中的 U-100、3 mL 单人使用预填充笔、NDC 0088-2219-05、5 支/盒展示面", "archiveMarket": "美国", "labelVersion": "DailyMed SPL v35（2025-07-02 发布）", "presentation": "LANTUS SoloStar 甘精胰岛素：100 units/mL（U-100），3 mL 单人使用预填充笔，NDC 0088-2219-05，5 支/盒展示面。", "notice": "此图只对应美国 DailyMed 当前标签中的 LANTUS SoloStar、甘精胰岛素、100 units/mL（U-100）、3 mL 单人使用预填充笔、NDC 0088-2219-05 与 5 支/盒。它只帮助核对品牌、通用名、标签浓度、剂型、装置、包装数量与来源；不用于鉴定真伪，也不证明 10 mL 小瓶、其他包装、其他市场、当前可得性、原研身份、可替代性，或任何个人的注射单位、注射时间、混用、换药或血糖处理方案。", "source": { "id": "src_aa60b67009c9d9ac", "label": "DailyMed（NLM）：LANTUS 甘精胰岛素当前美国公开标签（sanofi-aventis U.S.；SPL v35，2025-07-02 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d5e07a0c-7e14-4756-9152-9fea485d654a", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "LANTUS / 来得时说明书放大阅读：单位、浓度、注射装置不能只看一个数字", "en": "LANTUS label reading: units, concentration and delivery device cannot be reduced to one number" }, "summary": { "zh": "本模块以 FDA 与 DailyMed 的美国公开标签为阅读入口，帮助识别 LANTUS、甘精胰岛素、100 units/mL（U-100）、皮下注射途径及小瓶/预填充笔。它不生成个人注射单位、换用方案、混用方案或血糖处理方案。", "en": "This module uses U.S. FDA and DailyMed public labels as reading entry points for LANTUS, insulin glargine, 100 units/mL (U-100), the subcutaneous route and vial/prefilled-pen presentations. It does not generate individual injection units, switching, mixing or glucose-management plans." }, "checks": [ { "zh": "“100 units/mL（U-100）”描述的是该标签所列产品的浓度；“U（单位）”与 mg 不是可凭网页相互换算的同一单位。剂量窗显示、每次实际使用单位和产品浓度必须在医生或药师确认的准确装置、处方与现行标签中一起核对。", "en": "“100 units/mL (U-100)” describes the concentration of the labelled product. Units and mg are not one unit that can be converted from a webpage. A dose-window display, the actual units used and product concentration must be checked together against the exact device, prescription and current label with a clinician or pharmacist." }, { "zh": "同一公开档案中可见小瓶、预填充笔等不同包装/装置文字。它们是产品身份的一部分；不要把一支笔、一瓶或另一种胰岛素的经验套用到本产品，更不要根据外观或“都是甘精胰岛素”自行换算、替换或混用。", "en": "The public archive includes wording for different presentations such as vials and prefilled pens. They are part of product identity. Do not apply experience with another pen, vial or insulin to this product, or self-convert, substitute or mix products from appearance or a shared insulin-glargine name." }, { "zh": "标签提示每次注射前核对胰岛素标签，以降低用药错误风险；更改胰岛素方案可使高血糖或低血糖风险发生变化，需要密切的专业监督。出现困惑、产品改变、血糖异常或不适时，应使用实际包装和完整药单联系医疗团队，不要等待网页给出调整答案。", "en": "The label tells patients to check the insulin label before each injection to reduce medication errors, and notes that regimen changes can alter hyperglycaemia or hypoglycaemia risk and need close professional supervision. With confusion, a product change, abnormal glucose results or symptoms, contact the care team with the actual pack and complete medicine list rather than waiting for a website adjustment answer." }, { "zh": "包装图、品牌名或“长效”描述都不能鉴定真伪、证明可替代性或决定个人的注射时间与单位。此页不替代面对实际装置的教学；阅读、视力、记忆或操作困难时，请药师、护士或医生进行现场核对和示范。", "en": "A pack image, brand name or “long-acting” description cannot authenticate a product, prove interchangeability or decide an individual's injection timing or units. This page does not replace teaching with the actual device; seek an in-person check and demonstration from a pharmacist, nurse or clinician if reading, vision, memory or handling is difficult." } ], "source": { "id": "src_aa60b67009c9d9ac", "label": "DailyMed（NLM）：LANTUS 甘精胰岛素当前美国公开标签（sanofi-aventis U.S.；SPL v35，2025-07-02 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d5e07a0c-7e14-4756-9152-9fea485d654a", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "甘精胰岛素怎样起作用：它影响葡萄糖的利用与肝脏葡萄糖生成", "en": "How insulin glargine works: it affects glucose use and hepatic glucose production" }, "summary": { "zh": "FDA 公开标签将甘精胰岛素的主要作用归入调节葡萄糖代谢：促进外周组织，尤其骨骼肌和脂肪组织摄取葡萄糖，并抑制肝脏葡萄糖生成。这解释的是作用路径，不给出个人单位、注射时间、换用或低血糖处理方案。", "en": "The FDA public label describes insulin glargine's primary activity as regulating glucose metabolism: it stimulates peripheral glucose uptake, especially in skeletal muscle and fat, and inhibits hepatic glucose production. This explains a pathway; it does not give individual units, injection timing, switching or hypoglycaemia-management plans." }, "checks": [ { "zh": "机制不是“单位公式”。包装上的 100 units/mL 是浓度，U（单位）也不是可从网页换算成 mg 的同一单位；实际使用的单位、产品浓度和装置必须按准确处方与现行标签一起核对。", "en": "Mechanism is not a “unit formula.” The 100 units/mL on a pack is concentration, and U (units) is not the same unit as mg for webpage conversion; the actual units used, product concentration and device must be checked together against the exact prescription and current label." }, { "zh": "同属胰岛素或都标为“长效”并不使产品、装置或监测要求相同。不要仅凭共同机理、外观或名称片段自行替换、混用或调整。", "en": "Being insulins or both described as “long-acting” does not make products, devices or monitoring requirements the same. Do not self-substitute, mix or adjust from a shared mechanism, appearance or fragment of a name." }, { "zh": "血糖异常、身体不适、拿到不同包装或读不清装置时，网页的机制说明不能决定下一步。请带上实际产品和完整药单联系医疗团队或药师核对。", "en": "With abnormal glucose readings, feeling unwell, a different pack or uncertainty reading a device, a webpage mechanism explanation cannot decide the next step. Take the actual product and full medicine list to the care team or pharmacist for review." } ], "source": { "id": "src_aa60b67009c9d9ac", "label": "DailyMed（NLM）：LANTUS 甘精胰岛素当前美国公开标签（sanofi-aventis U.S.；SPL v35，2025-07-02 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d5e07a0c-7e14-4756-9152-9fea485d654a", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "Lantus", "generic": "甘精胰岛素", "dosageFormClass": "皮下注射液；U-100 10 mL 多剂量小瓶与 3 mL SoloStar 单人使用预填充笔为不同包装/装置形式（当前美国公开标签所列）" }, "labelSource": { "id": "src_aa60b67009c9d9ac", "label": "DailyMed（NLM）：LANTUS 甘精胰岛素当前美国公开标签（sanofi-aventis U.S.；SPL v35，2025-07-02 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d5e07a0c-7e14-4756-9152-9fea485d654a", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "productRoutes": [ { "source": { "id": "src_aa60b67009c9d9ac", "label": "DailyMed（NLM）：LANTUS 甘精胰岛素当前美国公开标签（sanofi-aventis U.S.；SPL v35，2025-07-02 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d5e07a0c-7e14-4756-9152-9fea485d654a", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "FDA 与 DailyMed 的 LANTUS（insulin glargine）公开标签将其列为皮下注射用甘精胰岛素，标签列示美国初始批准年份为 2000。此页用于放大阅读品牌、通用名、U-100 浓度、皮下注射途径以及小瓶/预填充笔等产品身份线索；不据此推定中国大陆或其他市场的当前批准、规格、持有人、原研关系、供应或可售资格。", "history": "胰岛素的“单位（U）”、每毫升浓度、注射装置和不同产品名称必须一起核对。即使通用名相近或都写“长效”，也不能从包装图、一个数字或经验自行换算、替换、混用或调整。", "sourceDocuments": [ { "id": "src_aa60b67009c9d9ac", "label": "DailyMed（NLM）：LANTUS 甘精胰岛素当前美国公开标签（sanofi-aventis U.S.；SPL v35，2025-07-02 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d5e07a0c-7e14-4756-9152-9fea485d654a", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } ], "applicationNumber": "BLA 021081", "approvalTimeline": [ { "date": "2000", "title": { "zh": "当前标签所列美国初始批准年份", "en": "Initial U.S. approval year listed in the current label" }, "detail": { "zh": "当前 LANTUS 标签列示 Initial U.S. Approval: 2000。该年份仅定位这一美国标签档案，不建立中国大陆、欧盟、日本或其他市场的批准、供应、可售资格、原研/仿制关系或个人适用性。", "en": "The current LANTUS label lists Initial U.S. Approval: 2000. This year locates this U.S. label record only; it does not establish approval, supply, sale eligibility, originator/generic relationship or individual suitability in Mainland China, the EU, Japan or another market." }, "source": { "id": "src_aa60b67009c9d9ac", "label": "DailyMed（NLM）：LANTUS 甘精胰岛素当前美国公开标签（sanofi-aventis U.S.；SPL v35，2025-07-02 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d5e07a0c-7e14-4756-9152-9fea485d654a", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, { "date": "2025-07-02", "title": { "zh": "DailyMed 当前公开 SPL v35", "en": "Current public SPL v35 published on DailyMed" }, "detail": { "zh": "DailyMed 将 LANTUS 当前 SPL v35 的发布日期列为 2025-07-02。本页分别展示一个 U-100 10 mL 多剂量小瓶和一个 U-100 3 mL SoloStar 单人使用预填充笔的准确标签面板；不据此建立实际在售、库存、个人注射单位、注射时间、混用、换药或其他包装状态。", "en": "DailyMed lists 2 Jul 2025 as the publication date for current LANTUS SPL v35. This page separately displays one exact U-100 10 mL multiple-dose vial panel and one U-100 3 mL SoloStar single-patient-use prefilled-pen panel; it does not establish actual availability, stock, individual injection units, injection timing, mixing, switching or another-package status." }, "source": { "id": "src_aa60b67009c9d9ac", "label": "DailyMed（NLM）：LANTUS 甘精胰岛素当前美国公开标签（sanofi-aventis U.S.；SPL v35，2025-07-02 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d5e07a0c-7e14-4756-9152-9fea485d654a", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "已链接当前标签、10 mL 小瓶与 3 mL SoloStar 准确包装面板", "en": "Current label, 10 mL vial and 3 mL SoloStar exact package panels linked" }, "detail": { "zh": "包装面板分别对应 NDC 0088-2220-33 小瓶和 NDC 0088-2219-05 SoloStar 预填充笔。它们不用于鉴定真伪，也不建立实际在售、库存、个人单位、注射时间、混用或可替代性。", "en": "The package panels correspond respectively to NDC 0088-2220-33 vial and NDC 0088-2219-05 SoloStar prefilled pen. They do not authenticate a product or establish actual availability, stock, individual units, injection timing, mixing or interchangeability." } }, { "market": { "zh": "中国大陆、欧盟、日本及其他市场", "en": "Mainland China, EU, Japan and other markets" }, "status": { "zh": "待逐项建立市场记录", "en": "Market record not established" }, "detail": { "zh": "不从美国标签或品牌名称推定当地商品名、批准、包装、供应、可售资格、原研/仿制关系或可替代性；任何市场版本均需按当地现行监管资料单独核对。", "en": "No local trade name, approval, packaging, supply, sale eligibility, originator/generic relationship or interchangeability is inferred from the U.S. label or brand name; every market version needs separate checking against current local regulatory information." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "U-100、10 mL 小瓶和 3 mL SoloStar 预填充笔能否仅凭数字或“都是甘精胰岛素”互换？", "en": "Can U-100, a 10 mL vial and a 3 mL SoloStar prefilled pen be exchanged from a number or a shared insulin-glargine name alone?" }, "answer": { "zh": "不能。U-100 是该标签中浓度的写法，10 mL 小瓶与 3 mL SoloStar 预填充笔是不同包装/装置身份。共同通用名、相同浓度或包装图片不能证明可自行换用、混用、调整单位或改变时间；请让药师或开方团队核对实际产品、处方和完整药单。", "en": "No. U-100 is the label's concentration notation, while the 10 mL vial and 3 mL SoloStar prefilled pen are different package/device identities. A shared generic name, matching concentration or package image does not establish self-switching, mixing, unit adjustment or a timing change; have a pharmacist or prescribing team review the actual product, prescription and complete medicine list." } }, { "question": { "zh": "为什么页面强调查看标签，却不提供个人单位或换用步骤？", "en": "Why does the page emphasise checking the label but not provide individual units or switching steps?" }, "answer": { "zh": "当前标签提示胰岛素方案改变可能影响高血糖或低血糖风险，且需要密切专业监督。网页的作用是帮助识别准确包装、浓度和来源，并把个人问题带回医疗团队；它不是剂量、换药、混用或血糖处理工具。", "en": "The current label notes that changes in an insulin regimen may affect hyperglycaemia or hypoglycaemia risk and need close professional supervision. This page helps identify the exact package, concentration and source, then routes individual questions back to the care team; it is not a tool for dosing, switching, mixing or glucose management." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "dosage-forms-are-part-of-medicine-identity", "medicine-label-for-everyday-questions", "how-to-read-a-drug-label" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/lantus/", "en": "https://origindrug.com/en/drugs/lantus/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "humalog", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-19", "status": "published_traceable_archive" }, "names": { "brand": "Humalog", "generic": "赖脯胰岛素", "aliases": [ "HUMALOG", "insulin lispro" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "代谢", "sourceArchiveMarket": "美国当前 HUMALOG 注射液公开标签（SPL v87；2026-06-16 更新，2026-08-10 发布）", "dosageFormClass": "赖脯胰岛素注射液：U-100 多剂量瓶、药筒与预充笔；U-200 KwikPen 预充笔（当前美国标签/NDC 记录所列）", "dosageFormClassCode": "injection_solution", "route": "皮下；仅 U-100 标签另列严格条件下的静脉输注或泵用路径", "routeCode": "presentation_specific", "historicalApprovalEntry": "1996（当前美国标签所列 Initial U.S. Approval）", "archiveSponsorText": "Eli Lilly and Company / DailyMed（NLM）当前公开标签档案" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [ "HUMALOG MIX75/25", "HUMALOG MIX 75/25", "HUMALOG MIX50/50", "HUMALOG MIX 50/50", "insulin lispro protamine and insulin lispro", "赖脯胰岛素混合" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-humalog-u100-vial-ndc-0002-7510-01", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v87；2026-06-16 更新，2026-08-10 发布", "en": "DailyMed SPL v87; updated 16 Jun 2026 and published 10 Aug 2026" }, "dosageForm": { "zh": "赖脯胰岛素注射液", "en": "insulin lispro injection solution" }, "route": { "zh": "皮下；静脉仅限稀释后且由医疗人员监督", "en": "subcutaneous; intravenous only after dilution and under medical supervision" }, "routeCodes": [ "subcutaneous", "intravenous" ], "productCode": "NDC 0002-7510-01", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "concentration", "primaryDisplay": { "zh": "U-100：100 单位/mL；10 mL 多剂量瓶", "en": "U-100: 100 units/mL; 10 mL multiple-dose vial" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=humalog-vial-carton-023-04.jpg&setid=c8ecbd7a-0e22-4fc7-a503-faa58c1b6f3f", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "赖脯胰岛素", "en": "insulin lispro" }, "value": 100, "unit": "units/mL", "basisCode": "concentration", "basisLabel": { "zh": "标签浓度；不是个人注射单位", "en": "labelled concentration; not an individual's injection units" } } ], "concentration": { "basisCode": "insulin_units_per_mL", "notation": "U-100", "numerator": { "value": 100, "unit": "units" }, "denominator": { "value": 1, "unit": "mL" }, "display": { "zh": "100 单位/mL（U-100）", "en": "100 units/mL (U-100)" } }, "container": { "typeCode": "multi_dose_vial", "typeLabel": { "zh": "10 mL 多剂量瓶", "en": "10 mL multiple-dose vial" }, "fill": { "value": 10, "unit": "mL" }, "countPerPackage": 1, "countUnit": { "zh": "瓶/盒", "en": "vial per carton" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-19", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 1, "unit": { "zh": "瓶/盒", "en": "vial per carton" } }, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_efa98d52d9adef66", "label": "DailyMed（NLM）：HUMALOG 赖脯胰岛素当前美国公开标签（Eli Lilly；SPL v87，2026-06-16 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c8ecbd7a-0e22-4fc7-a503-faa58c1b6f3f", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-humalog-u100-cartridge-ndc-0002-7516-59", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v87；2026-06-16 更新，2026-08-10 发布", "en": "DailyMed SPL v87; updated 16 Jun 2026 and published 10 Aug 2026" }, "dosageForm": { "zh": "赖脯胰岛素注射液", "en": "insulin lispro injection solution" }, "route": { "zh": "皮下", "en": "subcutaneous" }, "routeCodes": [ "subcutaneous" ], "productCode": "NDC 0002-7516-59", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "concentration", "primaryDisplay": { "zh": "U-100：100 单位/mL；5 支 3 mL 药筒", "en": "U-100: 100 units/mL; five 3 mL cartridges" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=humalog-cartridge-cart-004-06.jpg&setid=c8ecbd7a-0e22-4fc7-a503-faa58c1b6f3f", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "赖脯胰岛素", "en": "insulin lispro" }, "value": 100, "unit": "units/mL", "basisCode": "concentration", "basisLabel": { "zh": "标签浓度；不是个人注射单位", "en": "labelled concentration; not an individual's injection units" } } ], "concentration": { "basisCode": "insulin_units_per_mL", "notation": "U-100", "numerator": { "value": 100, "unit": "units" }, "denominator": { "value": 1, "unit": "mL" }, "display": { "zh": "100 单位/mL（U-100）", "en": "100 units/mL (U-100)" } }, "container": { "typeCode": "cartridge", "typeLabel": { "zh": "3 mL 单人使用药筒", "en": "3 mL single-patient-use cartridge" }, "fill": { "value": 3, "unit": "mL" }, "countPerPackage": 5, "countUnit": { "zh": "3 mL 药筒/盒", "en": "3 mL cartridges per carton" } }, "deliveryDevice": null, "compatibleReusableDevice": { "name": { "zh": "HumaPen LUXURA HD", "en": "HumaPen LUXURA HD" } }, "listingStatus": { "reviewedAt": "2026-08-19", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": "Disc", "statusConflictRequiresManualReview": true }, "package": { "count": 5, "unit": { "zh": "3 mL 药筒/盒", "en": "3 mL cartridges per carton" } }, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_efa98d52d9adef66", "label": "DailyMed（NLM）：HUMALOG 赖脯胰岛素当前美国公开标签（Eli Lilly；SPL v87，2026-06-16 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c8ecbd7a-0e22-4fc7-a503-faa58c1b6f3f", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-humalog-u100-kwikpen-ndc-0002-8799-59", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v87；2026-06-16 更新，2026-08-10 发布", "en": "DailyMed SPL v87; updated 16 Jun 2026 and published 10 Aug 2026" }, "dosageForm": { "zh": "赖脯胰岛素注射液", "en": "insulin lispro injection solution" }, "route": { "zh": "皮下", "en": "subcutaneous" }, "routeCodes": [ "subcutaneous" ], "productCode": "NDC 0002-8799-59", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "concentration", "primaryDisplay": { "zh": "U-100：100 单位/mL；5 支 3 mL KwikPen", "en": "U-100: 100 units/mL; five 3 mL KwikPens" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=humalog-u100-kpen-017-05.jpg&setid=c8ecbd7a-0e22-4fc7-a503-faa58c1b6f3f", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "赖脯胰岛素", "en": "insulin lispro" }, "value": 100, "unit": "units/mL", "basisCode": "concentration", "basisLabel": { "zh": "标签浓度；不是个人注射单位", "en": "labelled concentration; not an individual's injection units" } } ], "concentration": { "basisCode": "insulin_units_per_mL", "notation": "U-100", "numerator": { "value": 100, "unit": "units" }, "denominator": { "value": 1, "unit": "mL" }, "display": { "zh": "100 单位/mL（U-100）", "en": "100 units/mL (U-100)" } }, "container": { "typeCode": "prefilled_pen", "typeLabel": { "zh": "3 mL 单人使用预充笔", "en": "3 mL single-patient-use prefilled pen" }, "fill": { "value": 3, "unit": "mL" }, "countPerPackage": 5, "countUnit": { "zh": "3 mL 预充笔/盒", "en": "3 mL prefilled pens per carton" } }, "deliveryDevice": { "typeCode": "kwikpen", "name": { "zh": "KwikPen", "en": "KwikPen" } }, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-19", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 5, "unit": { "zh": "3 mL 预充笔/盒", "en": "3 mL prefilled pens per carton" } }, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_efa98d52d9adef66", "label": "DailyMed（NLM）：HUMALOG 赖脯胰岛素当前美国公开标签（Eli Lilly；SPL v87，2026-06-16 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c8ecbd7a-0e22-4fc7-a503-faa58c1b6f3f", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-humalog-u100-junior-kwikpen-ndc-0002-7714-59", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v87；2026-06-16 更新，2026-08-10 发布", "en": "DailyMed SPL v87; updated 16 Jun 2026 and published 10 Aug 2026" }, "dosageForm": { "zh": "赖脯胰岛素注射液", "en": "insulin lispro injection solution" }, "route": { "zh": "皮下", "en": "subcutaneous" }, "routeCodes": [ "subcutaneous" ], "productCode": "NDC 0002-7714-59", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "concentration", "primaryDisplay": { "zh": "U-100：100 单位/mL；5 支 3 mL Junior KwikPen", "en": "U-100: 100 units/mL; five 3 mL Junior KwikPens" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=humalog-jr-pen-carton-035-03.jpg&setid=c8ecbd7a-0e22-4fc7-a503-faa58c1b6f3f", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "赖脯胰岛素", "en": "insulin lispro" }, "value": 100, "unit": "units/mL", "basisCode": "concentration", "basisLabel": { "zh": "标签浓度；不是个人注射单位", "en": "labelled concentration; not an individual's injection units" } } ], "concentration": { "basisCode": "insulin_units_per_mL", "notation": "U-100", "numerator": { "value": 100, "unit": "units" }, "denominator": { "value": 1, "unit": "mL" }, "display": { "zh": "100 单位/mL（U-100）", "en": "100 units/mL (U-100)" } }, "container": { "typeCode": "prefilled_pen", "typeLabel": { "zh": "3 mL 单人使用预充笔", "en": "3 mL single-patient-use prefilled pen" }, "fill": { "value": 3, "unit": "mL" }, "countPerPackage": 5, "countUnit": { "zh": "3 mL 预充笔/盒", "en": "3 mL prefilled pens per carton" } }, "deliveryDevice": { "typeCode": "junior_kwikpen", "name": { "zh": "Junior KwikPen", "en": "Junior KwikPen" } }, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-19", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 5, "unit": { "zh": "3 mL 预充笔/盒", "en": "3 mL prefilled pens per carton" } }, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_efa98d52d9adef66", "label": "DailyMed（NLM）：HUMALOG 赖脯胰岛素当前美国公开标签（Eli Lilly；SPL v87，2026-06-16 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c8ecbd7a-0e22-4fc7-a503-faa58c1b6f3f", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-humalog-u100-tempo-pen-ndc-0002-8213-05", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v87；2026-06-16 更新，2026-08-10 发布", "en": "DailyMed SPL v87; updated 16 Jun 2026 and published 10 Aug 2026" }, "dosageForm": { "zh": "赖脯胰岛素注射液", "en": "insulin lispro injection solution" }, "route": { "zh": "皮下", "en": "subcutaneous" }, "routeCodes": [ "subcutaneous" ], "productCode": "NDC 0002-8213-05", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "concentration", "primaryDisplay": { "zh": "U-100：100 单位/mL；5 支 3 mL Tempo Pen", "en": "U-100: 100 units/mL; five 3 mL Tempo Pens" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=humalog-u100-tpen-047-01.jpg&setid=c8ecbd7a-0e22-4fc7-a503-faa58c1b6f3f", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "赖脯胰岛素", "en": "insulin lispro" }, "value": 100, "unit": "units/mL", "basisCode": "concentration", "basisLabel": { "zh": "标签浓度；不是个人注射单位", "en": "labelled concentration; not an individual's injection units" } } ], "concentration": { "basisCode": "insulin_units_per_mL", "notation": "U-100", "numerator": { "value": 100, "unit": "units" }, "denominator": { "value": 1, "unit": "mL" }, "display": { "zh": "100 单位/mL（U-100）", "en": "100 units/mL (U-100)" } }, "container": { "typeCode": "prefilled_pen", "typeLabel": { "zh": "3 mL 单人使用预充笔", "en": "3 mL single-patient-use prefilled pen" }, "fill": { "value": 3, "unit": "mL" }, "countPerPackage": 5, "countUnit": { "zh": "3 mL 预充笔/盒", "en": "3 mL prefilled pens per carton" } }, "deliveryDevice": { "typeCode": "tempo_pen", "name": { "zh": "Tempo Pen", "en": "Tempo Pen" } }, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-19", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 5, "unit": { "zh": "3 mL 预充笔/盒", "en": "3 mL prefilled pens per carton" } }, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_efa98d52d9adef66", "label": "DailyMed（NLM）：HUMALOG 赖脯胰岛素当前美国公开标签（Eli Lilly；SPL v87，2026-06-16 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c8ecbd7a-0e22-4fc7-a503-faa58c1b6f3f", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-humalog-u200-kwikpen-ndc-0002-7712-27", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v87；2026-06-16 更新，2026-08-10 发布", "en": "DailyMed SPL v87; updated 16 Jun 2026 and published 10 Aug 2026" }, "dosageForm": { "zh": "赖脯胰岛素注射液", "en": "insulin lispro injection solution" }, "route": { "zh": "皮下", "en": "subcutaneous" }, "routeCodes": [ "subcutaneous" ], "productCode": "NDC 0002-7712-27", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "concentration", "primaryDisplay": { "zh": "U-200：200 单位/mL；2 支 3 mL KwikPen", "en": "U-200: 200 units/mL; two 3 mL KwikPens" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=humalog-u200-kpen-014-03.jpg&setid=c8ecbd7a-0e22-4fc7-a503-faa58c1b6f3f", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "赖脯胰岛素", "en": "insulin lispro" }, "value": 200, "unit": "units/mL", "basisCode": "concentration", "basisLabel": { "zh": "标签浓度；不是个人注射单位", "en": "labelled concentration; not an individual's injection units" } } ], "concentration": { "basisCode": "insulin_units_per_mL", "notation": "U-200", "numerator": { "value": 200, "unit": "units" }, "denominator": { "value": 1, "unit": "mL" }, "display": { "zh": "200 单位/mL（U-200）", "en": "200 units/mL (U-200)" } }, "container": { "typeCode": "prefilled_pen", "typeLabel": { "zh": "3 mL 单人使用预充笔", "en": "3 mL single-patient-use prefilled pen" }, "fill": { "value": 3, "unit": "mL" }, "countPerPackage": 2, "countUnit": { "zh": "3 mL 预充笔/盒", "en": "3 mL prefilled pens per carton" } }, "deliveryDevice": { "typeCode": "kwikpen", "name": { "zh": "KwikPen", "en": "KwikPen" } }, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-19", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 2, "unit": { "zh": "3 mL 预充笔/盒", "en": "3 mL prefilled pens per carton" } }, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_efa98d52d9adef66", "label": "DailyMed（NLM）：HUMALOG 赖脯胰岛素当前美国公开标签（Eli Lilly；SPL v87，2026-06-16 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c8ecbd7a-0e22-4fc7-a503-faa58c1b6f3f", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-humalog-u200-kwikpen-ndc-0002-7712-27", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=humalog-u200-kpen-014-03.jpg&setid=c8ecbd7a-0e22-4fc7-a503-faa58c1b6f3f", "alt": "HUMALOG U-200 赖脯胰岛素美国 DailyMed 当前标签中的 200 units/mL、两支 3 mL KwikPen 包装面板", "archiveMarket": "美国", "labelVersion": "DailyMed SPL v87（2026-06-16 更新；2026-08-10 发布）", "presentation": "HUMALOG U-200，200 units/mL，2 支 3 mL KwikPen，NDC 0002-7712-27", "notice": "此图只对应美国当前标签中的 U-200 KwikPen 两支装。它不代表 U-100、药瓶、药筒、Junior KwikPen、Tempo Pen、HUMALOG MIX 或其他市场；不用于鉴定真伪，也不生成个人注射单位、浓度换算、泵/静脉使用或装置转换。", "source": { "id": "src_efa98d52d9adef66", "label": "DailyMed（NLM）：HUMALOG 赖脯胰岛素当前美国公开标签（Eli Lilly；SPL v87）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c8ecbd7a-0e22-4fc7-a503-faa58c1b6f3f", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "HUMALOG 说明书放大阅读：U-100/U-200、容器与装置必须同时核对", "en": "HUMALOG label reading: U-100/U-200, container and device must be checked together" }, "summary": { "zh": "本模块只帮助阅读当前美国标签中的浓度、容器、NDC、体积与装置；不生成个人注射单位、餐时、泵设置、补用、混合或转换。", "en": "This module only helps read concentration, container, NDC, volume and device in the current U.S. label; it does not generate personal injection units, meal timing, pump settings, make-up use, mixing or conversion." }, "checks": [ { "zh": "U-100 与 U-200 是不同浓度：100 units/mL 与 200 units/mL 不能只看“HUMALOG”或相同 3 mL 外观就当作同一产品。网页不提供二者的单位换算。", "en": "U-100 and U-200 are different concentrations: 100 units/mL and 200 units/mL cannot be treated as the same product from “HUMALOG” or a shared 3 mL appearance. This page provides no unit conversion between them." }, { "zh": "U-200 当前核验的 presentation 只有 KwikPen，不是药瓶或药筒；标签明确不得把 U-200 从笔中抽入注射器，也不得用于泵或静脉。出现装置或浓度不一致时，先停止网页推断并联系药师或开方团队。", "en": "The current reviewed U-200 presentation is KwikPen only, not a vial or cartridge. The label states not to transfer U-200 from the pen into a syringe and not to use it in a pump or intravenously. If device or concentration differs, stop web inference and contact a pharmacist or prescribing team." }, { "zh": "药瓶、药筒、KwikPen、Junior KwikPen 与 Tempo Pen 是不同容器/装置身份；不能因都写 3 mL 或 U-100 就自行转移、分装、共享、拼用或更换装置。", "en": "Vial, cartridge, KwikPen, Junior KwikPen and Tempo Pen are different container/device identities. A shared 3 mL or U-100 marking does not permit self-transfer, division, sharing, combining or device switching." }, { "zh": "HUMALOG MIX75/25 与 MIX50/50 是混悬型复方产品，不是本页的 HUMALOG 注射液。拍照或搜索出现 MIX、protamine/精蛋白或混悬液时，不应把本页当作同一档案。", "en": "HUMALOG MIX75/25 and MIX50/50 are suspension combination products, not the HUMALOG solution in this record. If a photo or search shows MIX, protamine or suspension, do not treat this as the same dossier." }, { "zh": "低血糖、意识改变、抽搐、无法安全吞咽或其他急性严重情况，应立即使用当地紧急医疗支持；网页不能用包装数字替代急救处理或个体化方案。", "en": "Hypoglycaemia with altered awareness, seizure, inability to swallow safely or another acute severe concern requires immediate local emergency support; package numbers on a webpage cannot replace emergency care or an individual plan." } ], "source": { "id": "src_efa98d52d9adef66", "label": "DailyMed（NLM）：HUMALOG 赖脯胰岛素当前美国公开标签（Eli Lilly；SPL v87）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c8ecbd7a-0e22-4fc7-a503-faa58c1b6f3f", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "赖脯胰岛素怎样起作用：帮助葡萄糖进入组织并影响肝脏葡萄糖输出", "en": "How insulin lispro works: supporting glucose uptake and affecting hepatic glucose output" }, "summary": { "zh": "当前标签把赖脯胰岛素的主要作用描述为调节葡萄糖代谢。机制只用于理解类别，不能预测个人血糖、给出单位、注射时间、餐时或泵设置。", "en": "The current label describes regulation of glucose metabolism as insulin lispro's primary activity. Mechanism only supports class understanding; it cannot predict individual glucose, provide units, injection timing, meal timing or pump settings." }, "checks": [ { "zh": "作用较快不等于网页能决定何时注射、注射多少或漏用后如何处理；这些问题必须回到准确浓度、装置、处方、监测记录与专业人员。", "en": "Rapid action does not let a webpage decide when or how much to inject or what to do after a missed use; those questions require the exact concentration, device, prescription, monitoring record and professionals." }, { "zh": "同属胰岛素或都标单位，不表示不同胰岛素、浓度、泵、药瓶、药筒或预充笔可自行等量替换、叠加或混合。", "en": "Sharing an insulin class or unit notation does not make different insulins, concentrations, pumps, vials, cartridges or pens self-equivalent, combinable or mixable." }, { "zh": "机制不能替代对低血糖、过敏、装置故障或血糖急剧变化的现场评估；有急性严重担忧时应优先使用当地紧急医疗支持。", "en": "Mechanism cannot replace in-person assessment of hypoglycaemia, allergy, device failure or a sharp glucose change; prioritise local urgent medical support for an acute serious concern." } ], "source": { "id": "src_efa98d52d9adef66", "label": "DailyMed（NLM）：HUMALOG 当前美国公开标签（Clinical Pharmacology）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c8ecbd7a-0e22-4fc7-a503-faa58c1b6f3f", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "Humalog", "generic": "赖脯胰岛素", "dosageFormClass": "赖脯胰岛素注射液：U-100 多剂量瓶、药筒与预充笔；U-200 KwikPen 预充笔（当前美国标签/NDC 记录所列）" }, "labelSource": { "id": "src_efa98d52d9adef66", "label": "DailyMed（NLM）：HUMALOG 赖脯胰岛素当前美国公开标签（Eli Lilly；SPL v87，2026-06-16 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c8ecbd7a-0e22-4fc7-a503-faa58c1b6f3f", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "productRoutes": [ { "source": { "id": "src_efa98d52d9adef66", "label": "DailyMed（NLM）：HUMALOG 赖脯胰岛素当前美国公开标签（Eli Lilly；SPL v87，2026-06-16 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c8ecbd7a-0e22-4fc7-a503-faa58c1b6f3f", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "DailyMed 的 HUMALOG（insulin lispro）当前美国公开标签把 U-100 与 U-200、10 mL 多剂量瓶、3 mL 药筒以及不同预充笔分别列示。截至 2026-08-19，本页按浓度、NDC、容器、装置、体积与包装数量核对现行标签展示且 FDA NDC 目录仍列出的六个 presentation；这不等于已证实在售、有库存或适用于任何个人，也不生成胰岛素单位、注射时间、餐时、泵设置、补用、混合、装置转换或浓度换算。", "history": "HUMALOG 当前标签列示美国初始批准年份为 1996。当前 presentation 以 2026-08-19 的 DailyMed v87 与 FDA NDC 记录为核验边界：已结束的 3 mL vial 和 U-200 Tempo Pen 不作为当前产品呈现；HUMALOG MIX75/25、MIX50/50 也不是本页同一注射液档案。", "sourceDocuments": [ { "id": "src_efa98d52d9adef66", "label": "DailyMed（NLM）：HUMALOG 赖脯胰岛素当前美国公开标签（Eli Lilly；SPL v87，2026-06-16 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c8ecbd7a-0e22-4fc7-a503-faa58c1b6f3f", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } ], "applicationNumber": "BLA 020563（U-100）/ BLA 205747（U-200）", "approvalTimeline": [ { "date": "1996-06-14", "title": { "zh": "U-100 美国批准节点", "en": "U-100 U.S. approval node" }, "detail": { "zh": "当前 DailyMed 数据元素将 U-100 产品列在 BLA 020563，并显示 1996-06-14 的营销/批准历史节点；标签列示 Initial U.S. Approval: 1996。", "en": "Current DailyMed data elements list U-100 under BLA 020563 and show a 14 Jun 1996 marketing/approval-history node; the label lists Initial U.S. Approval: 1996." }, "source": { "id": "src_efa98d52d9adef66", "label": "DailyMed: current HUMALOG public label and data elements", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c8ecbd7a-0e22-4fc7-a503-faa58c1b6f3f", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, { "date": "2015-05-26", "title": { "zh": "U-200 BLA 205747 节点", "en": "U-200 BLA 205747 node" }, "detail": { "zh": "当前 DailyMed 数据元素将 U-200 KwikPen 列在 BLA 205747，并显示 2015-05-26 的节点。该日期不把 U-100 与 U-200 合并为一个浓度。", "en": "Current DailyMed data elements list U-200 KwikPen under BLA 205747 and show a 26 May 2015 node. This does not collapse U-100 and U-200 into one concentration." }, "source": { "id": "src_efa98d52d9adef66", "label": "DailyMed: current HUMALOG public label and data elements", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c8ecbd7a-0e22-4fc7-a503-faa58c1b6f3f", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, { "date": "2026-01", "title": { "zh": "当前处方信息修订月份", "en": "Current prescribing-information revision month" }, "detail": { "zh": "当前正文页脚列示 Revised 01/2026；它与 SPL effective/Updated 和 DailyMed Published 日期分开记录。", "en": "The current prescribing-information footer lists Revised 01/2026; it remains distinct from SPL effective/updated and DailyMed published dates." }, "source": { "id": "src_efa98d52d9adef66", "label": "DailyMed: current HUMALOG public label", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c8ecbd7a-0e22-4fc7-a503-faa58c1b6f3f", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, { "date": "2026-06-16 / 2026-08-10", "title": { "zh": "SPL v87 更新与发布时间", "en": "SPL v87 update and publication dates" }, "detail": { "zh": "DailyMed 将当前 v87 的 Updated/Effective 标为 2026-06-16，并于 2026-08-10 发布；页面不把这两个日期都称为临床修订日。", "en": "DailyMed marks the current v87 as updated/effective on 16 Jun 2026 and published on 10 Aug 2026; this page does not call both dates clinical revision dates." }, "source": { "id": "src_efa98d52d9adef66", "label": "DailyMed: current HUMALOG public label", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c8ecbd7a-0e22-4fc7-a503-faa58c1b6f3f", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "已链接现行标签展示且 NDC 目录仍列出的六个 presentation", "en": "Six presentations shown in the current label and still listed in the NDC Directory are linked" }, "detail": { "zh": "核验截至 2026-08-19；U-100 与 U-200 的 BLA、浓度、容器和装置分别保留。这不证明实际在售、库存或可获得性；药筒记录还存在 NDC 列示与 Purple Book presentation 状态不一致，须单独人工复核。", "en": "Reviewed through 19 Aug 2026; the U-100 and U-200 BLA, concentration, container and device identities remain separate. This does not establish actual marketing, stock or availability; the cartridge record also has an NDC-listing versus Purple Book presentation-status discrepancy requiring separate manual review." } }, { "market": { "zh": "中国大陆、欧盟、日本及其他市场", "en": "Mainland China, EU, Japan and other markets" }, "status": { "zh": "待逐项建立市场记录", "en": "Market record not established" }, "detail": { "zh": "不从美国标签推定当地商品名、批准、装置、供应或可替代性。", "en": "No local trade name, approval, device, supply or interchangeability is inferred from the U.S. label." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "U-100 和 U-200 可以按体积或单位自行换算吗？", "en": "Can U-100 and U-200 be self-converted by volume or units?" }, "answer": { "zh": "不能。本页只显示产品身份，不提供换算器。应核对处方、浓度、NDC、准确装置并联系药师或开方团队。", "en": "No. This page displays product identity and provides no converter. Check the prescription, concentration, NDC and exact device with a pharmacist or prescribing team." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "dosage-forms-are-part-of-medicine-identity", "how-to-read-a-drug-label" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/humalog/", "en": "https://origindrug.com/en/drugs/humalog/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "yaz", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-09-04", "status": "published_traceable_archive" }, "names": { "brand": "YAZ", "generic": "屈螺酮/炔雌醇", "aliases": [ "YAZ", "Yaz", "drospirenone", "ethinyl estradiol", "屈螺酮", "炔雌醇", "屈螺酮炔雌醇片", "NDA 021676", "50419-405-03", "DS", "DP", "drospirenone and ethinyl estradiol", "NDC 50419-405-03" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "生殖健康", "sourceArchiveMarket": "美国当前公开标签与 FDA 产品记录：YAZ 3 mg/0.02 mg 复方口服片，24 片活性片＋4 片无活性片，每外包装 3 板；不外推其他市场批准、包装、供应或商品名", "dosageFormClass": "YAZ 屈螺酮/炔雌醇组合包装：每板 24 片浅粉色活性薄膜衣片＋4 片白色无活性薄膜衣片；每外包装 3 板", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "2006-03-16（FDA Drugs@FDA 所列 NDA 021676 原始批准日期）", "archiveSponsorText": "Bayer HealthCare Pharmaceuticals Inc. / FDA 与 DailyMed 当前公开监管记录" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [ "YASMIN", "BEYAZ", "SAFYRAL", "SLYND", "NEXTSTELLIS", "drospirenone-only tablets", "屈螺酮单方", "其他 21+7 或 24+4 复方避孕片" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-yaz-drospirenone-3mg-ethinyl-estradiol-0-02mg-24-active-4-inert-three-blister-packs-ndc-5041940503", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（2025-05-29 更新；SPL v21）", "en": "Current U.S. DailyMed public label (updated 29 May 2025; SPL v21)" }, "dosageForm": { "zh": "YAZ 屈螺酮/炔雌醇薄膜衣口服片组合包装", "en": "YAZ drospirenone/ethinyl estradiol film-coated oral-tablet kit" }, "route": { "zh": "口服（组合包装身份字段）", "en": "oral (kit product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 50419-405-03", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_active_tablet", "primaryDisplay": { "zh": "每板 24 片浅粉色活性片（每片屈螺酮 3 mg / 炔雌醇 0.02 mg）＋4 片白色无活性片；每外包装 3 板", "en": "Each blister has 24 light-pink active tablets (drospirenone 3 mg / ethinyl estradiol 0.02 mg per tablet) plus 4 white inert tablets; three blisters per outer pack" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=0ed216ab-0c5e-4e77-8170-114a2c530ae7-06.jpg&setid=065f33e4-b587-4e66-b896-ca9ab7b7c876&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "屈螺酮", "en": "drospirenone" }, "value": 3, "unit": "mg", "basisCode": "per_active_tablet", "basisLabel": { "zh": "每片浅粉色活性片的第一种成分；不能与 0.02 mg 相加，也不是个人应服片数", "en": "first ingredient per light-pink active tablet; not to be added to 0.02 mg and not an individual tablet count" } }, { "ingredient": { "zh": "炔雌醇", "en": "ethinyl estradiol" }, "value": 0.02, "unit": "mg", "basisCode": "per_active_tablet", "basisLabel": { "zh": "每片浅粉色活性片的第二种成分；白色无活性片不含这两种激素", "en": "second ingredient per light-pink active tablet; the white inert tablets do not contain these two hormones" } } ], "concentration": null, "container": { "typeCode": "three_blister_pack_kit", "typeLabel": { "zh": "三板组合外包装", "en": "three-blister outer pack" }, "fill": null, "countPerPackage": 3, "countUnit": { "zh": "板/外包装；每板 28 片", "en": "blisters per outer pack; 28 tablets per blister" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-04", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 3, "unit": { "zh": "板/外包装", "en": "blisters per outer pack" } }, "physicalClues": { "color": { "zh": "浅粉色活性片与白色无活性片", "en": "light-pink active and white inert tablets" }, "shape": { "zh": "圆形、无刻痕薄膜衣片", "en": "round, unscored film-coated tablets" }, "imprint": { "zh": "活性片 DS；无活性片 DP（均位于正六边形内）", "en": "DS on active tablets; DP on inert tablets (each within a regular hexagon)" }, "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_e050b7fd67ffa799", "label": "DailyMed（NLM）：YAZ 屈螺酮/炔雌醇当前美国公开标签与三板组合包装（SPL v21）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=065f33e4-b587-4e66-b896-ca9ab7b7c876", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-yaz-drospirenone-3mg-ethinyl-estradiol-0-02mg-24-active-4-inert-three-blister-packs-ndc-5041940503", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=0ed216ab-0c5e-4e77-8170-114a2c530ae7-06.jpg&setid=065f33e4-b587-4e66-b896-ca9ab7b7c876&type=img", "alt": "YAZ 屈螺酮/炔雌醇 NDC 50419-405-03 三板组合包装在 DailyMed 当前美国标签中的展示图", "archiveMarket": "美国", "labelVersion": "DailyMed 当前美国公开标签（2025-05-29 更新；SPL v21）", "presentation": "YAZ 每板 24 片浅粉色活性片＋4 片白色无活性片、每外包装 3 板、NDC 50419-405-03 展示面", "notice": "此图只帮助核对所引美国标签中的 YAZ、两种成分、24+4 片结构、三板外包装和 NDC；不用于鉴定真伪，也不证明其他市场品牌、批准、供应、可售资格、可替代性或任何个人使用方案。", "source": { "id": "src_e050b7fd67ffa799", "label": "DailyMed（NLM）：YAZ 当前美国公开标签与包装图（SPL v21）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=065f33e4-b587-4e66-b896-ca9ab7b7c876", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "YAZ 说明书放大阅读：先分清两种成分、活性片与无活性片", "en": "YAZ label reading: first separate the two ingredients and active versus inert tablets" }, "summary": { "zh": "这一标签最容易读错的不是一个数字，而是数字所属层级：每片两种成分、每板 24+4 片、每盒三板。网页帮助逐层核对，但不生成个人开始、漏服、补服、停用、换药或避孕方案。", "en": "The main reading risk is not one number but the layer it belongs to: two ingredients per active tablet, 24+4 tablets per blister and three blisters per box. The page helps separate those layers but does not generate an individual start, missed-use, make-up, stopping, switching or contraceptive plan." }, "checks": [ { "zh": "每片浅粉色活性片含屈螺酮 3 mg 和炔雌醇 0.02 mg；白色片是无活性片。3 与 0.02 不能相加成一个可比较强度，24、4、28 与三板也不是个人应服片数。", "en": "Each light-pink active tablet contains drospirenone 3 mg and ethinyl estradiol 0.02 mg; the white tablets are inert. The 3 and 0.02 figures are not added into one comparable strength, and 24, 4, 28 and three blisters are not an individual's tablet count." }, { "zh": "标签黑框警告指出，35 岁以上吸烟者不应使用 YAZ，吸烟会增加复方口服避孕药相关严重心血管事件风险。胸痛、呼吸困难、单侧腿部肿痛、突发神经症状或其他急性严重表现应立即使用当地急救渠道，而不是等待网页判断。", "en": "The boxed warning states that women over 35 who smoke should not use YAZ and that smoking increases serious cardiovascular-event risk with combined oral contraceptives. Chest pain, breathing difficulty, one-sided leg swelling or pain, sudden neurologic symptoms or another acute serious concern requires immediate local emergency help, not a web decision." }, { "zh": "屈螺酮具有抗盐皮质激素活性；肾上腺、肾脏或肝脏问题，以及补钾、保钾利尿剂、螺内酯、ACEI、ARB、醛固酮拮抗剂、肝素或长期每日 NSAID 等同在药单时，要优先核对血钾和完整药单。网页不生成停药或错开方案。", "en": "Drospirenone has antimineralocorticoid activity. Adrenal, kidney or liver problems, or co-listing potassium, potassium-sparing diuretics, spironolactone, an ACE inhibitor, ARB, aldosterone antagonist, heparin or long-term daily NSAID use requires priority review of potassium and the complete medicine list. The page does not create a stop or separation plan." }, { "zh": "YASMIN、BEYAZ、SAFYRAL、SLYND 和其他 21+7 或 24+4 产品可能成分、雌激素、叶酸、活性片数或标签不同；不能按商品名、颜色、片数或共同的屈螺酮自行替换、拼接或轮换。", "en": "YASMIN, BEYAZ, SAFYRAL, SLYND and other 21+7 or 24+4 products can differ in ingredients, oestrogen, folate, active-tablet count or label. Brand, colour, tablet count or shared drospirenone does not permit self-substitution, assembly or alternation." } ], "source": { "id": "src_e050b7fd67ffa799", "label": "DailyMed（NLM）：YAZ 当前美国公开标签——黑框警告、包装、禁忌、血钾与相互作用", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=065f33e4-b587-4e66-b896-ca9ab7b7c876", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "作用机制阅读：抑制排卵是主要机制，不等于可自行选用或替换", "en": "Mechanism reading: ovulation suppression is primary, not permission to self-select or switch" }, "summary": { "zh": "当前标签把复方口服避孕药的主要作用描述为抑制排卵，并说明宫颈黏液和子宫内膜变化也可能参与。屈螺酮还具有抗盐皮质激素和抗雄激素活性。机制只解释药理路径，不判断个人适用性、血栓风险、是否需要化验或应选哪一款。", "en": "The current label describes suppression of ovulation as the primary action of combined oral contraceptives, with cervical-mucus and endometrial changes also possibly contributing. Drospirenone also has antimineralocorticoid and antiandrogenic activity. Mechanism explains pharmacology; it does not decide individual suitability, clot risk, testing needs or product choice." }, "checks": [ { "zh": "“都能抑制排卵”不能把不同复方避孕药变成可一比一替换产品；激素种类、每片含量、活性/无活性片结构、相互作用与目标市场标签都要逐项核对。", "en": "‘Both suppress ovulation’ does not make different combined contraceptives one-for-one substitutes. Hormone identities, per-tablet amounts, active/inert structure, interactions and the target-market label all require separate review." }, { "zh": "抗盐皮质激素活性解释了为什么血钾与相关联用药需要关注，但不能从机制推算个人是否安全、需要何种化验或如何调整其他药。", "en": "Antimineralocorticoid activity explains why potassium and related co-medications need attention, but mechanism cannot calculate individual safety, testing or adjustment of another medicine." }, { "zh": "本页不把机制扩展为常规全基因筛查建议。是否适用要结合吸烟、年龄、偏头痛、血栓史、肝肾与肾上腺情况、完整药单和现行标签，由负责团队判断。", "en": "This page does not extend mechanism into routine whole-genome screening advice. Suitability requires smoking status, age, migraine, clot history, hepatic, renal and adrenal status, the complete medicine list and current label, assessed by the responsible team." } ], "source": { "id": "src_e050b7fd67ffa799", "label": "DailyMed（NLM）：YAZ 当前美国公开标签——临床药理与作用机制", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=065f33e4-b587-4e66-b896-ca9ab7b7c876", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "YAZ", "generic": "屈螺酮/炔雌醇", "dosageFormClass": "YAZ 屈螺酮/炔雌醇组合包装：每板 24 片浅粉色活性薄膜衣片＋4 片白色无活性薄膜衣片；每外包装 3 板" }, "labelSource": { "id": "src_e050b7fd67ffa799", "label": "DailyMed（NLM）：YAZ 屈螺酮/炔雌醇当前美国公开标签（2025-05-29 更新；SPL v21）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=065f33e4-b587-4e66-b896-ca9ab7b7c876", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" }, "productRoutes": [ { "source": { "id": "src_e050b7fd67ffa799", "label": "DailyMed（NLM）：YAZ 屈螺酮/炔雌醇当前美国公开标签（2025-05-29 更新；SPL v21）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=065f33e4-b587-4e66-b896-ca9ab7b7c876", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-09-04", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_11400c4c99f4c228", "label": "FDA Drugs@FDA：YAZ NDA 021676 产品、RLD/RS 与审批历史", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=021676", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" }, "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-09-04", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-09-04", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "YAZ 是屈螺酮/炔雌醇复方口服片的美国品牌监管档案。每板含 24 片浅粉色活性片，每片分别含屈螺酮 3 mg 和炔雌醇 0.02 mg，另有 4 片白色无活性片；每个 NDC 50419-405-03 外包装含三板。两个 mg 数字属于同一片中的两种成分，24、4、28 和 3 属于不同包装层级，不能相加或改写为个人应服片数、漏服处理、换药或避孕方案。", "history": "FDA Drugs@FDA 记录 NDA 021676 于 2006-03-16 原始批准，并把当前 3 mg/0.02 mg 口服片列为 RLD 与 RS。DailyMed 当前公开标签（2025-05-29 更新，SPL v21）由 Bayer 发布，列示 NDC 50419-405-03、三板包装、24 片活性片和 4 片无活性片。标签同时写有 Initial U.S. Approval: 2001，这是复方所依托产品历史表述，不能替代 NDA 021676 的原始批准日期。YASMIN、BEYAZ、SAFYRAL、SLYND 及其他市场产品均不能并入这一准确包装。", "sourceDocuments": [ { "id": "src_e050b7fd67ffa799", "label": "DailyMed（NLM）：YAZ 屈螺酮/炔雌醇当前美国公开标签（2025-05-29 更新；SPL v21）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=065f33e4-b587-4e66-b896-ca9ab7b7c876", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" }, { "id": "src_11400c4c99f4c228", "label": "FDA Drugs@FDA：YAZ NDA 021676 产品、RLD/RS 与审批历史", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=021676", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" }, { "id": "src_862034bf7cd36bc3", "label": "FDA：YAZ NDA 021676 原始批准函（2006-03-16）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021676s000ltr.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "approval_letter", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" } ], "applicationNumber": "FDA NDA 021676（YAZ；drospirenone/ethinyl estradiol tablets）", "approvalTimeline": [ { "date": "2006-03-16", "title": { "zh": "FDA 原始批准 YAZ NDA 021676", "en": "FDA original approval of YAZ NDA 021676" }, "detail": { "zh": "Drugs@FDA 的申请历史把该日期列为 ORIG-1 Approval；这是美国监管历史节点，不是其他市场批准、供应或个人适用性结论。", "en": "The Drugs@FDA application history lists this date as the ORIG-1 approval. It is a U.S. regulatory-history point, not another market's approval, supply or individual-suitability conclusion." }, "source": { "id": "src_11400c4c99f4c228", "label": "FDA Drugs@FDA：YAZ NDA 021676 产品与申请历史", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=021676", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" } }, { "date": "2025-05-29", "title": { "zh": "当前 DailyMed SPL v21 更新", "en": "Current DailyMed SPL v21 updated" }, "detail": { "zh": "本页的准确 NDC、三板包装、活性/无活性片、外观、黑框警告和相互作用阅读均以该公开标签为主要来源；标签更新日期不等于渠道库存。", "en": "The exact NDC, three-blister pack, active/inert tablet distinction, appearance, boxed warning and interaction reading use this public label as the primary source. A label-update date is not channel stock." }, "source": { "id": "src_e050b7fd67ffa799", "label": "DailyMed（NLM）：YAZ 当前美国公开标签（SPL v21）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=065f33e4-b587-4e66-b896-ca9ab7b7c876", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "NDA 021676 当前产品记录与公开标签已建立", "en": "Current product record and public label established under NDA 021676" }, "detail": { "zh": "3 mg/0.02 mg 口服片在 Drugs@FDA 当前表中为处方 RLD 与 RS；本页只记录准确公开标签和包装身份，不声称实时供应或购买资格。", "en": "The 3 mg/0.02 mg oral tablet is currently listed by Drugs@FDA as a prescription RLD and RS. This page records the exact public label and pack identity, not real-time supply or purchase eligibility." } }, { "market": { "zh": "中国大陆、欧盟、日本及其他市场", "en": "Mainland China, EU, Japan and other markets" }, "status": { "zh": "现行品牌、批准、包装和参比关系待逐市场核验", "en": "Current brand, approval, pack and reference status not yet established market by market" }, "detail": { "zh": "不从美国 YAZ 商品名、NDA、RLD/RS、NDC、24+4 结构或颜色推定当地产品身份、批准、供应、可售资格或可替代性。", "en": "No local product identity, approval, supply, sale eligibility or interchangeability is inferred from the U.S. YAZ name, NDA, RLD/RS status, NDC, 24+4 structure or colours." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "3 mg、0.02 mg、24、4、28 和 3 分别是什么意思？", "en": "What do 3 mg, 0.02 mg, 24, 4, 28 and 3 each mean?" }, "answer": { "zh": "3 mg 与 0.02 mg 是每片浅粉色活性片中两种不同成分的标示量；每板有 24 片活性片和 4 片白色无活性片，共 28 片；外包装有 3 板。这些数字不能相加，也不能单独回答某个人怎么吃。", "en": "3 mg and 0.02 mg are the labelled amounts of two different ingredients in each light-pink active tablet. Each blister has 24 active and 4 white inert tablets, 28 total, and the outer pack has three blisters. These numbers are not added and do not by themselves answer how an individual should use the product." } }, { "question": { "zh": "漏了一片或拿错颜色，网页能直接告诉我补几片吗？", "en": "Can the page tell me how many to make up after a missed or wrong-colour tablet?" }, "answer": { "zh": "不能。活性片与无活性片、漏了几片、处于哪一段、是否呕吐腹泻及其他用药都会改变需要核对的标签路径。请立即查手中准确包装的患者说明并联系药师或开方团队；不要按网上通用表自行补服。", "en": "No. Active versus inert tablet, how many were missed, cycle position, vomiting or diarrhoea and other medicines change which exact-label path applies. Check the patient information for the pack in hand and contact a pharmacist or prescribing team promptly; do not self-make-up from a generic online chart." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/yaz/", "en": "https://origindrug.com/en/drugs/yaz/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "plan-b-one-step", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-09-04", "status": "published_traceable_archive" }, "names": { "brand": "PLAN B ONE-STEP", "generic": "左炔诺孕酮", "aliases": [ "PLAN B ONE-STEP", "Plan B One-Step", "levonorgestrel", "左炔诺孕酮", "左炔诺孕酮片", "NDA 021998", "69536-162-88", "G00", "levonorgestrel tablet", "NDC 69536-162-88" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "生殖健康", "sourceArchiveMarket": "美国当前 OTC Drug Facts 与 FDA 产品记录：PLAN B ONE-STEP 左炔诺孕酮 1.5 mg 单片零售包装；不外推其他市场批准、供应、商品名或使用规则", "dosageFormClass": "PLAN B ONE-STEP 左炔诺孕酮 1.5 mg 口服片：NDC 69536-162-88，每盒 1 板、每板 1 片", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "2009-07-10（FDA Drugs@FDA 所列 NDA 021998 原始批准日期）", "archiveSponsorText": "Foundation Consumer Healthcare LLC / FDA 与 DailyMed 当前公开监管记录" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [ "NDC 69536-146-19（仅供诊所使用、非零售）", "历史双片 PLAN B 包装", "其他左炔诺孕酮 1.5 mg OTC 产品", "ella / ulipristal acetate", "常规复方口服避孕药", "宫内节育器" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-plan-b-one-step-levonorgestrel-1-5mg-one-tablet-blister-box-ndc-6953616288", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国 OTC Drug Facts（2023-01-31 更新；SPL v5）", "en": "Current U.S. DailyMed OTC Drug Facts (updated 31 Jan 2023; SPL v5)" }, "dosageForm": { "zh": "PLAN B ONE-STEP 左炔诺孕酮口服片", "en": "PLAN B ONE-STEP levonorgestrel oral tablet" }, "route": { "zh": "口服（美国 OTC 标签产品身份字段）", "en": "oral (U.S. OTC label product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 69536-162-88", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片左炔诺孕酮 1.5 mg；每盒 1 板、每板 1 片", "en": "Levonorgestrel 1.5 mg per tablet; one blister with one tablet per carton" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=plan-b-one-step-01.jpg&setid=6ce6b40e-14ac-47bd-a648-ddf9e452e559", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "左炔诺孕酮", "en": "levonorgestrel" }, "value": 1.5, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；1.5 mg 不是包装片数，也不能单独生成个人使用方案", "en": "labelled amount per tablet; 1.5 mg is not a package count and cannot by itself generate an individual-use plan" } } ], "concentration": null, "container": { "typeCode": "single_tablet_blister_carton", "typeLabel": { "zh": "单片泡罩纸盒", "en": "single-tablet blister carton" }, "fill": null, "countPerPackage": 1, "countUnit": { "zh": "板/盒", "en": "blister per carton" }, "unitsPerContainer": { "count": 1, "unit": { "zh": "片/板", "en": "tablet per blister" } } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-04", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 1, "unit": { "zh": "片/盒", "en": "tablet per carton" } }, "physicalClues": { "color": { "zh": "白色至类白色", "en": "white to off-white" }, "shape": { "zh": "圆形、无刻痕", "en": "round, unscored" }, "imprint": "G00", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_df073f3c4596f4b8", "label": "DailyMed（NLM）：PLAN B ONE-STEP 当前美国 OTC 标签与单片零售包装（SPL v5）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=6ce6b40e-14ac-47bd-a648-ddf9e452e559", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-plan-b-one-step-levonorgestrel-1-5mg-one-tablet-blister-box-ndc-6953616288", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=plan-b-one-step-01.jpg&setid=6ce6b40e-14ac-47bd-a648-ddf9e452e559", "alt": "PLAN B ONE-STEP 左炔诺孕酮 1.5 mg、NDC 69536-162-88 单片零售包装的 DailyMed 标签图", "archiveMarket": "美国", "labelVersion": "DailyMed 当前美国 OTC Drug Facts（2023-01-31 更新；SPL v5）", "presentation": "白色至类白色圆形无刻痕片、G00 刻印、每板 1 片、每盒 1 板、NDC 69536-162-88", "notice": "此图只帮助核对所引美国零售标签的品牌、成分量、NDC、单片包装和外观；不用于鉴定真伪，也不覆盖诊所专用 NDC、其他市场或其他左炔诺孕酮产品。", "source": { "id": "src_df073f3c4596f4b8", "label": "DailyMed（NLM）：PLAN B ONE-STEP 当前美国 OTC 单片零售包装图（SPL v5）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=6ce6b40e-14ac-47bd-a648-ddf9e452e559", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "PLAN B ONE-STEP 说明书放大阅读：先分清 1.5 mg 与一盒 1 片", "en": "PLAN B ONE-STEP label reading: separate 1.5 mg from the one-tablet pack" }, "summary": { "zh": "这一 Drug Facts 最容易读错的是把每片成分量、整盒片数和个人使用时点混成一件事。网页逐层解释所引美国标签，但不判断个人是否适用，也不生成重复使用、替换或衔接方案。", "en": "This Drug Facts can be misread by collapsing the per-tablet amount, carton count and an individual's timing into one thing. The page separates the cited U.S. label layers but does not decide suitability or generate repeat-use, substitution or transition plans." }, "checks": [ { "zh": "每片含左炔诺孕酮 1.5 mg；NDC 69536-162-88 每盒一板、一片。片剂为白色至类白色、圆形、G00 刻印且无刻痕。无刻痕和单片包装都不是自行掰半、改变含量或分次使用的依据。", "en": "Each tablet contains levonorgestrel 1.5 mg; NDC 69536-162-88 has one blister and one tablet per carton. The tablet is white to off-white, round, marked G00 and unscored. Neither the unscored tablet nor single-tablet pack permits self-splitting, dose alteration or divided use." }, { "zh": "所引美国 Drug Facts 写的是无保护性行为或避孕失败后尽快、并在 72 小时内使用；若两小时内呕吐，应联系专业人员。本页只复述这一准确美国标签，不能外推其他产品、市场或个人情况；时间敏感或不确定时应立即联系药师、医生或当地生殖健康服务。", "en": "The cited U.S. Drug Facts says to use as soon as possible within 72 hours after unprotected sex or contraceptive failure and to contact a healthcare professional if vomiting occurs within two hours. This page reports that exact U.S. label only and cannot extend it to another product, market or individual circumstance; time-sensitive uncertainty requires prompt contact with a pharmacist, clinician or local reproductive-health service." }, { "zh": "标签说明它不是常规避孕方法，也不预防 HIV/AIDS 或其他性传播感染；不得把“紧急避孕”读成终止已经存在的妊娠、日常避孕、感染防护或效果保证。", "en": "The label states that it is not regular birth control and does not protect against HIV/AIDS or other sexually transmitted infections. ‘Emergency contraception’ must not be read as ending an existing pregnancy, regular contraception, infection protection or an effectiveness guarantee." }, { "zh": "依法韦仑、利福平或某些癫痫用药可能降低效果，标签要求先询问医生或药师。请带上处方药、非处方药、草药、实际包装和完整药单共同核对；共同成分、相同 1.5 mg 或其他 OTC 商品名不证明可以自行替换。", "en": "Efavirenz, rifampin or certain seizure medicines may reduce effectiveness, and the label says to ask a doctor or pharmacist first. Review prescriptions, OTC products, herbals, actual packs and the complete medicine list together; a shared ingredient, matching 1.5 mg amount or another OTC brand does not prove self-substitutability." } ], "source": { "id": "src_df073f3c4596f4b8", "label": "DailyMed（NLM）：PLAN B ONE-STEP 当前美国 OTC Drug Facts——用途、方向、相互作用与警告", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=6ce6b40e-14ac-47bd-a648-ddf9e452e559", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "作用机制阅读：紧急避孕不是终止已有妊娠", "en": "Mechanism reading: emergency contraception does not end an existing pregnancy" }, "summary": { "zh": "所引美国标签把本品用于无保护性行为或避孕失败后的紧急避孕，并明确写明不会终止已经存在的妊娠。机制与标签范围只能帮助理解产品，不能预测个人效果或替代临床判断。", "en": "The cited U.S. label describes emergency contraception after unprotected sex or contraceptive failure and explicitly states that it will not end an existing pregnancy. Mechanism and label scope help explain the product but cannot predict individual effectiveness or replace clinical judgment." }, "checks": [ { "zh": "“左炔诺孕酮”是成分身份，不代表所有含该成分的产品具有相同批准、包装、标签、时间窗口或可替代性。必须核对准确产品与目标市场说明书。", "en": "‘Levonorgestrel’ is an ingredient identity; it does not make every product with that ingredient identical in approval, pack, label, time window or interchangeability. Check the exact product and target-market label." }, { "zh": "出现明显下腹痛、疑似妊娠、月经显著延迟或其他令人担忧的表现时，应及时联系医疗服务；网页不通过机制文字诊断宫外孕、妊娠或个人风险。", "en": "Marked lower-abdominal pain, suspected pregnancy, a substantially delayed period or another concerning feature requires timely healthcare contact. The page does not diagnose ectopic pregnancy, pregnancy or individual risk from mechanism text." }, { "zh": "本页不把紧急避孕药机制扩展为常规全基因筛查建议，也不生成与 YAZ、其他口服避孕药或宫内节育器的换算、叠加或轮换方案。", "en": "This page does not extend emergency-contraception mechanism into routine whole-genome screening or generate conversion, combination or rotation plans with YAZ, another oral contraceptive or an intrauterine device." } ], "source": { "id": "src_df073f3c4596f4b8", "label": "DailyMed（NLM）：PLAN B ONE-STEP 当前美国 OTC Drug Facts——产品用途与既存妊娠边界", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=6ce6b40e-14ac-47bd-a648-ddf9e452e559", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "PLAN B ONE-STEP", "generic": "左炔诺孕酮", "dosageFormClass": "PLAN B ONE-STEP 左炔诺孕酮 1.5 mg 口服片：NDC 69536-162-88，每盒 1 板、每板 1 片" }, "labelSource": { "id": "src_df073f3c4596f4b8", "label": "DailyMed（NLM）：PLAN B ONE-STEP 左炔诺孕酮当前美国 OTC 标签（2023-01-31 更新；SPL v5）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=6ce6b40e-14ac-47bd-a648-ddf9e452e559", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" }, "productRoutes": [ { "source": { "id": "src_df073f3c4596f4b8", "label": "DailyMed（NLM）：PLAN B ONE-STEP 左炔诺孕酮当前美国 OTC 标签（2023-01-31 更新；SPL v5）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=6ce6b40e-14ac-47bd-a648-ddf9e452e559", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-09-04", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_a7233cd52f9fae69", "label": "FDA Drugs@FDA：PLAN B ONE-STEP NDA 021998 产品、RLD/RS 与审批历史", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=021998", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" }, "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-09-04", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-09-04", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "PLAN B ONE-STEP 是美国 OTC 左炔诺孕酮紧急避孕药的品牌监管档案。准确零售展示面为 NDC 69536-162-88：每片含左炔诺孕酮 1.5 mg，每盒只有一板、一片。1.5 mg 是每片成分量，1 片是包装数量；网页不会由此生成个人是否适用、是否需要再次使用、如何替代或与其他避孕方法衔接的方案。", "history": "FDA Drugs@FDA 记录 NDA 021998 于 2009-07-10 原始批准，并把当前 PLAN B ONE-STEP 1.5 mg 口服片列为 OTC、RLD 与 RS。DailyMed 当前公开 OTC Drug Facts 于 2023-01-31 更新（SPL v5），列示单片、圆形白色至类白色、G00 刻印、无刻痕以及零售 NDC 69536-162-88。NDC 69536-146-19 明示仅供诊所使用、不得零售，不能作为本页零售包装展示面。", "sourceDocuments": [ { "id": "src_df073f3c4596f4b8", "label": "DailyMed（NLM）：PLAN B ONE-STEP 左炔诺孕酮当前美国 OTC 标签（2023-01-31 更新；SPL v5）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=6ce6b40e-14ac-47bd-a648-ddf9e452e559", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" }, { "id": "src_a7233cd52f9fae69", "label": "FDA Drugs@FDA：PLAN B ONE-STEP NDA 021998 产品、RLD/RS 与审批历史", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=021998", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" }, { "id": "src_3cba6889fa3fce7d", "label": "FDA：PLAN B ONE-STEP NDA 021998 原始批准函（2009-07-10）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021998s000ltr.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "approval_letter", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" } ], "applicationNumber": "FDA NDA 021998（PLAN B ONE-STEP；levonorgestrel 1.5 mg tablet）", "approvalTimeline": [ { "date": "2009-07-10", "title": { "zh": "FDA 原始批准 PLAN B ONE-STEP NDA 021998", "en": "FDA original approval of PLAN B ONE-STEP NDA 021998" }, "detail": { "zh": "Drugs@FDA 将 ORIG-1 列为新剂型批准，并把当前 1.5 mg 片剂列为 OTC RLD 与 RS；这是美国监管历史与参照身份，不是其他市场结论。", "en": "Drugs@FDA lists ORIG-1 as a new-dosage-form approval and the current 1.5 mg tablet as an OTC RLD and RS. This is U.S. regulatory history and reference status, not another market's conclusion." }, "source": { "id": "src_a7233cd52f9fae69", "label": "FDA Drugs@FDA：PLAN B ONE-STEP NDA 021998 产品、RLD/RS 与审批历史", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=021998", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" } }, { "date": "2023-01-31", "title": { "zh": "当前 DailyMed OTC Drug Facts 更新", "en": "Current DailyMed OTC Drug Facts updated" }, "detail": { "zh": "本页成分量、单片零售包装、外观、使用范围、相互作用和安全阅读以该公开标签为主要来源；标签更新时间不等于实时供应。", "en": "The ingredient amount, single-tablet retail pack, appearance, use scope, interactions and safety reading use this public label as the primary source. A label-update date is not real-time availability." }, "source": { "id": "src_df073f3c4596f4b8", "label": "DailyMed（NLM）：PLAN B ONE-STEP 当前美国 OTC 标签（SPL v5）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=6ce6b40e-14ac-47bd-a648-ddf9e452e559", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "NDA 021998 当前 OTC 产品记录与公开 Drug Facts 已建立", "en": "Current OTC product record and public Drug Facts established under NDA 021998" }, "detail": { "zh": "1.5 mg 口服片在 Drugs@FDA 当前表中为 RLD 与 RS。本页记录准确标签和零售包装身份，不声明任何渠道库存、真伪或个人适用性。", "en": "The 1.5 mg oral tablet is currently listed by Drugs@FDA as an RLD and RS. This page records the exact label and retail-pack identity without claiming channel stock, authenticity or individual suitability." } }, { "market": { "zh": "中国大陆、欧盟、日本及其他市场", "en": "Mainland China, EU, Japan and other markets" }, "status": { "zh": "现行批准、品牌、包装和使用说明待逐市场核验", "en": "Current approval, brand, pack and directions not yet established market by market" }, "detail": { "zh": "不从美国商品名、OTC 身份、NDA、RLD/RS、NDC、72 小时文字或单片包装推定当地批准、供应、可售资格或个人方案。", "en": "No local approval, supply, sale eligibility or individual plan is inferred from the U.S. brand, OTC status, NDA, RLD/RS, NDC, 72-hour wording or single-tablet pack." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "1.5 mg 和一盒 1 片分别是什么意思？", "en": "What do 1.5 mg and one tablet per carton mean?" }, "answer": { "zh": "1.5 mg 是这一准确标签产品每片含有的左炔诺孕酮量；一盒 1 片只是包装数量。二者不能相乘、拆分或改写为某个人应使用几次。", "en": "1.5 mg is the amount of levonorgestrel in each tablet of this exact labelled product; one tablet is only the carton count. The figures cannot be multiplied, split or converted into how many times an individual should use it." } }, { "question": { "zh": "它是日常避孕药或性传播感染防护吗？", "en": "Is it regular birth control or protection from sexually transmitted infections?" }, "answer": { "zh": "不是。所引美国 Drug Facts 明确写明它不是常规避孕方法，也不预防 HIV/AIDS 或其他性传播感染。个人后续避孕、暴露或感染风险应联系相应专业服务。", "en": "No. The cited U.S. Drug Facts states that it is not regular birth control and does not protect against HIV/AIDS or other sexually transmitted infections. Individual follow-on contraception, exposure or infection risk requires the appropriate professional service." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/plan-b-one-step/", "en": "https://origindrug.com/en/drugs/plan-b-one-step/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "cozaar", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-21", "status": "published_traceable_archive" }, "names": { "brand": "Cozaar", "generic": "氯沙坦", "aliases": [ "losartan", "losartan potassium", "氯沙坦", "氯沙坦钾", "氯沙坦钾片", "科素亚" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": { "value": "科素亚®", "status": "discovery_cue_requires_target_market_verification", "source": { "id": "src_12c669e1551146c5", "label": "汉中市医疗保障局：2026 年常用药品价格监测中的科素亚／氯沙坦钾片记录", "url": "https://ybj.hanzhong.gov.cn/hzsylbzj/qsdt/202607/d240c590a9cb40d0a5dbb76261aaaf6f.shtml", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "government_medicine_listing", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-12", "reviewedAt": "2026-09-12" } } }, "identity": { "therapeuticArea": "心血管", "sourceArchiveMarket": "美国 DailyMed 有日期公开标签（页面 2026-01-20 更新；本档案分别展示三种 90 片瓶装面板）", "dosageFormClass": "氯沙坦钾口服薄膜衣片：25 mg、50 mg、100 mg（DailyMed 页面 2026-01-20 更新；本档案分别展示三种 90 片瓶装面板）", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "1995（FDA 标签所列美国初始批准）", "archiveSponsorText": "FDA / DailyMed 公开监管标签档案" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [ "HYZAAR", "losartan hydrochlorothiazide", "氯沙坦钾氢氯噻嗪" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-cozaar-losartan-potassium-tablet-25mg-7820612101", "marketCode": "US", "labelVersion": { "zh": "DailyMed 页面 2026-01-20 更新的公开标签", "en": "public DailyMed label page updated 20 Jan 2026" }, "dosageForm": { "zh": "氯沙坦钾口服薄膜衣片", "en": "losartan potassium oral film-coated tablet" }, "route": { "zh": "口服（仅作标签产品身份字段）", "en": "oral (label product-identity field only)" }, "routeCodes": [ "oral" ], "productCode": "NDC 78206-121-01", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片 25 mg；90 片瓶装", "en": "25 mg per tablet; 90-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=9949448f-c3b9-44ee-94ed-c1aca8c90f39&name=cozaar-06.jpg", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "氯沙坦钾", "en": "losartan potassium" }, "value": 25, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人服用片数、加减、补服、换药或换算指令", "en": "labelled amount per tablet; not an individual tablet count, adjustment, make-up, switching or conversion instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "塑料瓶", "en": "plastic bottle" }, "fill": null, "countPerPackage": 90, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-21", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 90, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "白色", "en": "white" }, "shape": { "zh": "椭圆形", "en": "oval" }, "imprint": "951", "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_74a7cc80f5ceab0c", "label": "DailyMed（NLM）：COZAAR 氯沙坦钾 25 mg、90 片瓶装美国公开标签面板（Organon；页面 2026-01-20 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=9949448f-c3b9-44ee-94ed-c1aca8c90f39", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-cozaar-losartan-potassium-tablet-50mg-7820612202", "marketCode": "US", "labelVersion": { "zh": "DailyMed 页面 2026-01-20 更新的公开标签", "en": "public DailyMed label page updated 20 Jan 2026" }, "dosageForm": { "zh": "氯沙坦钾口服薄膜衣片", "en": "losartan potassium oral film-coated tablet" }, "route": { "zh": "口服（仅作标签产品身份字段）", "en": "oral (label product-identity field only)" }, "routeCodes": [ "oral" ], "productCode": "NDC 78206-122-02", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片 50 mg；90 片瓶装", "en": "50 mg per tablet; 90-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=9949448f-c3b9-44ee-94ed-c1aca8c90f39&name=cozaar-07.jpg", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "氯沙坦钾", "en": "losartan potassium" }, "value": 50, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人服用片数、加减、补服、换药或换算指令", "en": "labelled amount per tablet; not an individual tablet count, adjustment, make-up, switching or conversion instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "塑料瓶", "en": "plastic bottle" }, "fill": null, "countPerPackage": 90, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-21", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 90, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "白色", "en": "white" }, "shape": { "zh": "椭圆形", "en": "oval" }, "imprint": "952", "scoreStatus": "scored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_74a7cc80f5ceab0c", "label": "DailyMed（NLM）：COZAAR 氯沙坦钾 50 mg、90 片瓶装美国公开标签面板（Organon；页面 2026-01-20 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=9949448f-c3b9-44ee-94ed-c1aca8c90f39", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-cozaar-losartan-potassium-tablet-100mg-7820612302", "marketCode": "US", "labelVersion": { "zh": "DailyMed 页面 2026-01-20 更新的公开标签", "en": "public DailyMed label page updated 20 Jan 2026" }, "dosageForm": { "zh": "氯沙坦钾口服薄膜衣片", "en": "losartan potassium oral film-coated tablet" }, "route": { "zh": "口服（仅作标签产品身份字段）", "en": "oral (label product-identity field only)" }, "routeCodes": [ "oral" ], "productCode": "NDC 78206-123-02", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片 100 mg；90 片瓶装", "en": "100 mg per tablet; 90-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=9949448f-c3b9-44ee-94ed-c1aca8c90f39&name=cozaar-08.jpg", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "氯沙坦钾", "en": "losartan potassium" }, "value": 100, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人服用片数、加减、补服、换药或换算指令", "en": "labelled amount per tablet; not an individual tablet count, adjustment, make-up, switching or conversion instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "塑料瓶", "en": "plastic bottle" }, "fill": null, "countPerPackage": 90, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-21", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 90, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "白色", "en": "white" }, "shape": { "zh": "水滴形", "en": "teardrop-shaped" }, "imprint": "960", "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_74a7cc80f5ceab0c", "label": "DailyMed（NLM）：COZAAR 氯沙坦钾 100 mg、90 片瓶装美国公开标签面板（Organon；页面 2026-01-20 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=9949448f-c3b9-44ee-94ed-c1aca8c90f39", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-cozaar-losartan-potassium-tablet-25mg-7820612101", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=cozaar-06.jpg&setid=9949448f-c3b9-44ee-94ed-c1aca8c90f39&type=img", "alt": "COZAAR 25 mg 薄膜衣片在美国 DailyMed 公开标签中的瓶装主展示图", "archiveMarket": "美国", "labelVersion": "2026-01", "presentation": "COZAAR 25 mg 薄膜衣片瓶装主展示面（DailyMed 页面所列 2026-01 更新标签）", "notice": "此为美国 DailyMed 公开标签中的包装文字图，只帮助核对 COZAAR、通用名、标示强度和口服片剂线索；不用于鉴定真伪，也不证明原研身份、当前包装、目标市场批准或可售资格。", "source": { "id": "src_74a7cc80f5ceab0c", "label": "DailyMed（NLM）：COZAAR 公开标签（2026-01 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=9949448f-c3b9-44ee-94ed-c1aca8c90f39", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "COZAAR 说明书放大阅读：25、50、100 mg 是产品强度，不是自行加减的规则", "en": "COZAAR label reading: 25, 50 and 100 mg are product strengths, not self-adjustment rules" }, "summary": { "zh": "本模块以 DailyMed 2026-01 美国公开标签为阅读入口，帮助核对 COZAAR、氯沙坦钾、口服片剂、不同 mg 和包装文字；它不把药盒数字转化为个人剂量、联用、停药或换药方案。", "en": "This module uses the Jan 2026 U.S. DailyMed public label as a reading entry point. It helps check COZAAR, losartan potassium, oral tablets, different mg markings and package text; it does not convert package numbers into an individual dose, combination, stop or switch plan." }, "checks": [ { "zh": "公开标签列有 25、50、100 mg 片剂。每个数字首先是该片的标示强度；不同 mg、不同市场或不同包装不能自行拼凑成“今天该吃几片”的答案。应以实际处方和现行标签为准。", "en": "The public label lists 25, 50 and 100 mg tablets. Each number first identifies that tablet's stated strength; different mg markings, markets or packages cannot be self-combined into an answer for how many tablets to take today. Use the actual prescription and current label." }, { "zh": "公开标签显示 50 mg 片剂带刻痕；刻痕是这一准确产品的外观和标签线索，不是对其他规格、其他产品或自行调剂量的许可。是否可分割、怎样使用应由药师或开方团队针对实际包装确认。", "en": "The public label shows a score on the 50 mg tablet. A score is an appearance and label clue for that exact product, not permission to split another strength or product or to self-adjust a dose. A pharmacist or prescribing team must confirm whether and how an actual pack may be divided." }, { "zh": "标签把升高血钾风险、锂盐、非甾体抗炎药，以及双重作用于肾素-血管紧张素系统的药物列为需要核对的事项。止痛药、补充剂、其他降压药和完整药单都应主动交给药师或医生；网页不能给出个人“能不能同服”的结论。", "en": "The label identifies raised-potassium risk, lithium, non-steroidal anti-inflammatory medicines and dual renin-angiotensin-system blockade as items needing review. Pain medicines, supplements, other blood-pressure medicines and the complete list should be given to a pharmacist or clinician; a webpage cannot give an individual “can these be taken together” conclusion." }, { "zh": "怀孕、近期脱水、肾功能或其他健康状况变化，都可能改变需要由专业人员复核的内容。不要因为血压读数、剩余药片或包装变化自行停用、加量、交替或改用其他同类药。", "en": "Pregnancy, recent dehydration, kidney-function changes or other health changes can alter what needs professional review. Do not self-stop, increase, alternate or substitute another related medicine because of a blood-pressure reading, remaining tablets or a package change." } ], "source": { "id": "src_74a7cc80f5ceab0c", "label": "DailyMed（NLM）：COZAAR 公开标签（2026-01 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=9949448f-c3b9-44ee-94ed-c1aca8c90f39", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "氯沙坦怎样起作用：它阻断血管紧张素 II 的 AT₁ 受体", "en": "How losartan works: it blocks the AT1 receptor for angiotensin II" }, "summary": { "zh": "FDA 标签将 COZAAR 描述为血管紧张素 II 受体阻滞剂（ARB）。它选择性阻断血管紧张素 II 与 AT₁ 受体结合，从而影响这条肾素-血管紧张素系统通路。这个机制解释的是药理路径，不预测个人血压、肾功能、血钾、剂量或是否应改用另一种降压药。", "en": "The FDA label describes COZAAR as an angiotensin II receptor blocker (ARB). It selectively blocks angiotensin II binding at the AT1 receptor, affecting this renin-angiotensin-system pathway. This explains a pharmacologic pathway, not an individual's blood pressure, kidney function, potassium, dose or whether to change to another blood-pressure medicine." }, "checks": [ { "zh": "同为 ARB，或同样写有“血管紧张素”，不表示 COZAAR 能与缬沙坦、ACE 抑制剂、含复方降压药或其他降压药自行叠加、交替或替换。具体产品、完整药单、血压和病史需要由专业人员一起核对。", "en": "Being an ARB, or sharing the word “angiotensin,” does not make COZAAR self-combinable, alternatable or substitutable with valsartan, an ACE inhibitor, a combination blood-pressure product or another antihypertensive. The specific product, complete medicine list, blood pressure and history need joint professional review." }, { "zh": "AT₁ 受体机制不能把 25、50、100 mg 或带刻痕的片剂变成自行加减、掰分或换算的规则。任何关于规格、分割或旧药替换的疑问都应回到准确包装、现行标签和药师/开方团队。", "en": "An AT1-receptor mechanism cannot turn 25, 50 or 100 mg, or a scored tablet, into self-adjustment, splitting or conversion rules. Questions about strength, splitting or replacing an older medicine must return to the exact package, current label and pharmacist/prescribing team." }, { "zh": "脱水、肾功能或血钾变化、怀孕，以及同时使用止痛药、补充剂或锂盐等情况，不能靠机制页面自行处理。出现头晕、晕厥或其他新问题时，应带完整药单寻求当地医疗支持。", "en": "Dehydration, kidney-function or potassium changes, pregnancy, and concurrent pain medicines, supplements or lithium cannot be managed by a mechanism page. With dizziness, fainting or another new concern, use local medical support with the complete medicine list." } ], "source": { "id": "src_14e776cbce2e0897", "label": "FDA：COZAAR 2025 美国处方信息（临床药理）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/020386s069lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "Cozaar", "generic": "氯沙坦", "dosageFormClass": "氯沙坦钾口服薄膜衣片：25 mg、50 mg、100 mg（DailyMed 页面 2026-01-20 更新；本档案分别展示三种 90 片瓶装面板）" }, "labelSource": { "id": "src_74a7cc80f5ceab0c", "label": "DailyMed（NLM）：COZAAR 公开标签（2026-01 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=9949448f-c3b9-44ee-94ed-c1aca8c90f39", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "productRoutes": [ { "source": { "id": "src_74a7cc80f5ceab0c", "label": "DailyMed（NLM）：COZAAR 公开标签（2026-01 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=9949448f-c3b9-44ee-94ed-c1aca8c90f39", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_14e776cbce2e0897", "label": "FDA：COZAAR 2025 美国处方信息（NDA 020386）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/020386s069lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "美国 DailyMed 的 COZAAR（losartan potassium）有日期公开标签列有 25 mg、50 mg、100 mg 口服薄膜衣片；本页分别建立三个 90 片瓶装面板的品牌、通用名、每片强度、NDC、外观线索和来源核对卡。它不把包装数字变成个人片数、加减、补服、停用、换药或联用方案，也不据此推定原研关系、目标市场批准、供应或销售资格。", "history": "FDA 历史标签记录其美国初始批准年份为 1995。本页的三个包装面板只对应 DailyMed 页面 2026-01-20 更新时所列的 COZAAR 25 mg、50 mg、100 mg、90 片瓶装；HYZAAR 等氯沙坦/氢氯噻嗪复方产品不能按品牌或成分重叠并入本单方片剂档案。", "sourceDocuments": [ { "id": "src_14e776cbce2e0897", "label": "FDA：COZAAR 2025 美国处方信息（NDA 020386）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/020386s069lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_74a7cc80f5ceab0c", "label": "DailyMed（NLM）：COZAAR 公开标签（2026-01 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=9949448f-c3b9-44ee-94ed-c1aca8c90f39", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_5ed30b676fbb9773", "label": "FDA Drugs@FDA 官方检索入口", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_lookup_entry", "documentKind": "regulatory_lookup", "market": "US", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } ], "applicationNumber": "NDA 020386", "approvalTimeline": [ { "date": "1995", "title": { "zh": "FDA 标签所列美国初始批准年份", "en": "Initial U.S. approval year listed in the FDA label" }, "detail": { "zh": "本页链接的 FDA 标签档案列示 Initial U.S. Approval: 1995。该历史定位不等同于当前批准、可得性、持有人或其他市场状态。", "en": "The FDA label archive linked here lists Initial U.S. Approval: 1995. This historical locator is not a conclusion about current approval, availability, holder or another market." }, "source": { "id": "src_14e776cbce2e0897", "label": "FDA: COZAAR prescribing information", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/020386s069lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, { "date": "2025", "title": { "zh": "FDA 标签档案版本", "en": "FDA label archive version" }, "detail": { "zh": "本页链接 2025 的 FDA 标签档案作为可复核阅读入口。现行标签、规格、适应症和安全信息必须另行以目标市场当前文件核对。", "en": "This page links the 2025 FDA label archive as a traceable reading entry point. Current labeling, strength, indication and safety information require separate verification against the target market’s current document." }, "source": { "id": "src_14e776cbce2e0897", "label": "FDA: COZAAR prescribing information", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/020386s069lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "已链接公开标签档案", "en": "Public label archive linked" }, "detail": { "zh": "仅对应本页所列 FDA 文件。", "en": "Only the FDA document listed on this page is linked." } }, { "market": { "zh": "中国大陆、欧盟、日本", "en": "Mainland China, EU, Japan" }, "status": { "zh": "待逐项建立市场记录", "en": "Market record not established" }, "detail": { "zh": "不从美国标签档案推定当地批准、持有人、规格、供应或可售资格。", "en": "No local approval, holder, strength, supply or sale-eligibility conclusion is inferred from the U.S. label archive." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "标签档案能代表现在的产品信息吗？", "en": "Does a label archive represent current product information?" }, "answer": { "zh": "不能自动代表。档案用于定位来源；需要以目标市场的现行官方标签逐项复核。", "en": "Not automatically. The archive locates a source; each point needs verification against the target market’s current official label." } }, { "question": { "zh": "为什么这里不展示价格或原研/仿制结论？", "en": "Why are price and originator/generic conclusions not shown?" }, "answer": { "zh": "这些结论需要产品、剂型、规格、包装、市场、日期和原始记录分别齐全并经人工审核；单一标签文件不足以支持。", "en": "Those conclusions require separately complete and human-reviewed product, dosage-form, strength, pack, market, date and primary-record fields; one label file is insufficient." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "how-to-read-a-drug-label", "regulatory-sources-first" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/cozaar/", "en": "https://origindrug.com/en/drugs/cozaar/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "benicar", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-28", "status": "published_traceable_archive" }, "names": { "brand": "Benicar", "generic": "奥美沙坦酯", "aliases": [ "BENICAR", "olmesartan medoxomil", "olmesartan", "奥美沙坦酯" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "心血管", "sourceArchiveMarket": "美国：DailyMed 有日期公开标签（2023-07 更新）列出 BENICAR 奥美沙坦酯 5 mg、20 mg、40 mg 口服薄膜衣片及各 30 片瓶装。本页只建立这份美国标签的产品身份与阅读入口；不据此推定中国大陆、欧盟、日本或其他市场的批准、供应、可售、原研/仿制关系、真伪或可替代性。", "dosageFormClass": "奥美沙坦酯口服薄膜衣片：5 mg、20 mg、40 mg（美国公开标签所列；各 30 片瓶装）", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "2002（美国公开标签所列 Initial U.S. Approval）", "archiveSponsorText": "Cosette Pharmaceuticals, Inc.（所引美国公开标签所列标签方）" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [ "BENICAR HCT", "olmesartan medoxomil hydrochlorothiazide", "奥美沙坦酯氢氯噻嗪", "olmesartan injection" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-benicar-olmesartan-medoxomil-tablet-5mg-30-bottle-ndc-0713086030", "marketCode": "US", "labelVersion": { "zh": "DailyMed 美国公开标签（2023-07 更新）；仅为所引公开标签记录，不代表供应", "en": "U.S. DailyMed public label (updated Jul 2023); cited public-label record only, not availability" }, "dosageForm": { "zh": "BENICAR 奥美沙坦酯口服薄膜衣片", "en": "BENICAR olmesartan medoxomil film-coated oral tablet" }, "route": { "zh": "口服（标签产品身份字段）", "en": "oral (label product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 0713-0860-30", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片奥美沙坦酯 5 mg；30 片瓶装（美国公开标签）", "en": "Olmesartan medoxomil 5 mg per tablet; 30-tablet bottle (U.S. public label)" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "奥美沙坦酯", "en": "olmesartan medoxomil" }, "value": 5, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "5 mg 是每片标签标示量；不是个人片数、频率或换算指令", "en": "5 mg is a labelled amount per tablet; not an individual's tablet count, frequency or conversion instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "片", "en": "tablets" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-23", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 30, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "黄色", "en": "yellow" }, "shape": { "zh": "圆形薄膜衣片；无刻痕，外观线索不是分片指令", "en": "round film-coated tablet; unscored, an appearance clue rather than a splitting instruction" }, "imprint": "Sankyo / C12", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_44ef083a89cdfd0e", "label": "DailyMed（NLM）：BENICAR 奥美沙坦酯美国公开标签（Cosette；2023-07 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=5b6f8a18-8f8a-4521-81c3-3a39c73c6646", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-benicar-olmesartan-medoxomil-tablet-20mg-30-bottle-ndc-0713086130", "marketCode": "US", "labelVersion": { "zh": "DailyMed 美国公开标签（2023-07 更新）；仅为所引公开标签记录，不代表供应", "en": "U.S. DailyMed public label (updated Jul 2023); cited public-label record only, not availability" }, "dosageForm": { "zh": "BENICAR 奥美沙坦酯口服薄膜衣片", "en": "BENICAR olmesartan medoxomil film-coated oral tablet" }, "route": { "zh": "口服（标签产品身份字段）", "en": "oral (label product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 0713-0861-30", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片奥美沙坦酯 20 mg；30 片瓶装（美国公开标签）", "en": "Olmesartan medoxomil 20 mg per tablet; 30-tablet bottle (U.S. public label)" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "奥美沙坦酯", "en": "olmesartan medoxomil" }, "value": 20, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "20 mg 是每片标签标示量；不是个人片数、频率或换算指令", "en": "20 mg is a labelled amount per tablet; not an individual's tablet count, frequency or conversion instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "片", "en": "tablets" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-23", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 30, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "白色", "en": "white" }, "shape": { "zh": "圆形薄膜衣片；无刻痕，外观线索不是分片指令", "en": "round film-coated tablet; unscored, an appearance clue rather than a splitting instruction" }, "imprint": "Sankyo / C14", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_44ef083a89cdfd0e", "label": "DailyMed（NLM）：BENICAR 奥美沙坦酯美国公开标签（Cosette；2023-07 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=5b6f8a18-8f8a-4521-81c3-3a39c73c6646", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-benicar-olmesartan-medoxomil-tablet-40mg-30-bottle-ndc-0713086230", "marketCode": "US", "labelVersion": { "zh": "DailyMed 美国公开标签（2023-07 更新）；仅为所引公开标签记录，不代表供应", "en": "U.S. DailyMed public label (updated Jul 2023); cited public-label record only, not availability" }, "dosageForm": { "zh": "BENICAR 奥美沙坦酯口服薄膜衣片", "en": "BENICAR olmesartan medoxomil film-coated oral tablet" }, "route": { "zh": "口服（标签产品身份字段）", "en": "oral (label product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 0713-0862-30", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片奥美沙坦酯 40 mg；30 片瓶装（美国公开标签）", "en": "Olmesartan medoxomil 40 mg per tablet; 30-tablet bottle (U.S. public label)" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "奥美沙坦酯", "en": "olmesartan medoxomil" }, "value": 40, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "40 mg 是每片标签标示量；不是个人片数、频率或换算指令", "en": "40 mg is a labelled amount per tablet; not an individual's tablet count, frequency or conversion instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "片", "en": "tablets" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-23", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 30, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "白色", "en": "white" }, "shape": { "zh": "椭圆形薄膜衣片；无刻痕，外观线索不是分片指令", "en": "oval film-coated tablet; unscored, an appearance clue rather than a splitting instruction" }, "imprint": "Sankyo / C15", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_44ef083a89cdfd0e", "label": "DailyMed（NLM）：BENICAR 奥美沙坦酯美国公开标签（Cosette；2023-07 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=5b6f8a18-8f8a-4521-81c3-3a39c73c6646", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "status": "withheld_repackaged_or_non_exact_visual", "title": { "zh": "已核验公开标签文字，但未保留可一一对应的官方原品牌包装图，故不展示包装图片", "en": "The public-label text was reviewed, but no one-to-one official original-brand package image was retained, so no package visual is shown" }, "summary": { "zh": "本档案保留 DailyMed 公开标签中 BENICAR、奥美沙坦酯、5 mg／20 mg／40 mg、三个 NDC、各 30 片瓶装和片剂外观文字。未将零售图、版本不明图、其他市场图或无法对应单一强度/NDC 的图片呈现为准确原品牌包装，因此页面不展示包装图片，只保留可放大阅读的一手标签。", "en": "This dossier retains BENICAR, olmesartan medoxomil, 5 mg/20 mg/40 mg, three NDCs, 30-tablet bottles and tablet-appearance wording from the DailyMed public label. No retail image, version-uncertain image, another-market image or image without a single strength/NDC match is presented as an exact original-brand package, so the page withholds package imagery and retains the primary label for enlarged reading." }, "source": { "id": "src_44ef083a89cdfd0e", "label": "DailyMed（NLM）：BENICAR 奥美沙坦酯美国公开标签（Cosette；2023-07 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=5b6f8a18-8f8a-4521-81c3-3a39c73c6646", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "BENICAR 说明书放大阅读：先认清奥美沙坦酯、5／20／40 mg 与准确瓶装", "en": "BENICAR label reading: identify olmesartan medoxomil, 5/20/40 mg and the exact bottle first" }, "summary": { "zh": "本模块只阅读所引美国公开标签中的 BENICAR、奥美沙坦酯、每片 5/20/40 mg、三个 NDC、各 30 片瓶装与标签警示。它不提供个人血压目标、片数、漏用、分片、加药、停药、与其他降压药或补充剂联用、替换或购买方案。", "en": "This module reads only the cited U.S. public label: BENICAR, olmesartan medoxomil, 5/20/40 mg per tablet, three NDCs, 30-tablet bottles and label warnings. It does not provide individual blood-pressure targets, tablet counts, missed-use, splitting, adding, stopping, co-use with another blood-pressure medicine or supplement, switching or purchasing plans." }, "checks": [ { "zh": "先同时核对 BENICAR、奥美沙坦酯、每片 5/20/40 mg、NDC、30 片瓶装和目标市场。mg 只是这一准确片剂的标签标示量；不是网页可换算成个人片数、把不同强度相加或以另一种降压药替代的规则。", "en": "Check BENICAR, olmesartan medoxomil, 5/20/40 mg per tablet, NDC, the 30-tablet bottle and target market together. mg is only the labelled amount in an exact tablet, not a web rule for tablet counts, adding strengths or replacing another blood-pressure medicine." }, { "zh": "标签将这三种片剂描述为无刻痕；颜色、形状和压印是药盒/药片核对线索，不是自行掰开、调量、混用或由一种强度替代另一种的指令。", "en": "The label describes all three tablets as unscored. Color, shape and imprint are pack/tablet checking clues, not instructions to self-split, change use, combine products or replace one strength with another." }, { "zh": "标签含胎儿毒性警告，并列出低血压、肾功能变化、高钾和与某些药物相互作用等需要核对的内容。怀孕/备孕、肾脏问题、脱水不适、其他降压药、止痛药、锂盐、补钾产品或盐替代品等情形，应由了解完整病史和药单的医生或药师逐项核对；页面不据此决定继续、暂停、补用或改变治疗。", "en": "The label includes a fetal-toxicity warning and material to review about hypotension, renal-function changes, high potassium and interactions with certain medicines. Pregnancy or planning pregnancy, kidney problems, dehydration symptoms, another blood-pressure medicine, pain medicine, lithium, potassium product or salt substitute require item-by-item review by a clinician or pharmacist who knows the full history and medicine list; this page does not decide continuation, pausing, make-up use or a treatment change." }, { "zh": "出现晕厥、呼吸困难、意识改变、严重过敏表现或其他急性严重不适时，应使用当地紧急与医疗渠道；不要等待网页检索，也不要依据本页自行加药、停药或以另一盒药抵消。", "en": "For fainting, breathing difficulty, altered consciousness, serious allergic features or another acute severe concern, use local urgent and medical pathways; do not wait for a web search or self-add, stop or counteract with another pack based on this page." } ], "source": { "id": "src_44ef083a89cdfd0e", "label": "DailyMed（NLM）：BENICAR 奥美沙坦酯美国公开标签（Warnings, interactions and product identity）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=5b6f8a18-8f8a-4521-81c3-3a39c73c6646", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "奥美沙坦酯怎样起作用：阻断血管紧张素 II 的 AT1 受体作用路径", "en": "How olmesartan medoxomil works: it blocks an angiotensin II AT1-receptor pathway" }, "summary": { "zh": "所引标签将奥美沙坦描述为血管紧张素 II 受体阻断剂，并说明它选择性阻断血管平滑肌上的 AT1 受体结合。这个机制说明药物类别和标签阅读线索，不预测个人血压、肾功能、血钾、适用性、片数或联合方案。", "en": "The cited label describes olmesartan as an angiotensin II receptor blocker and says it selectively blocks binding at AT1 receptors in vascular smooth muscle. This explains a drug class and label-reading clue; it does not predict an individual's blood pressure, renal function, potassium, suitability, tablet count or combination plan." }, "checks": [ { "zh": "“AT1 受体阻断剂”是机制类别，不是从网页判断血压读数、头晕、化验异常或是否需要调整的工具。任何治疗决定都需要由专业人员结合准确诊断、检查、现行标签和完整药单作出。", "en": "“AT1 receptor blocker” is a mechanism class, not a website tool for interpreting a blood-pressure reading, dizziness, an abnormal test or a need for adjustment. Treatment decisions need a professional with the exact diagnosis, tests, current label and complete medicine list." }, { "zh": "同属 ARB、同有 AT1 机制、名称相近或包装上都有 mg，均不证明可以自行叠加、轮换、补用或替换。请把所有处方药、非处方药、补充剂及实际药盒交由药师或开方团队核对。", "en": "Being ARBs, sharing an AT1 mechanism, having similar names or showing mg on packages does not establish that products can be self-combined, alternated, made up or replaced. Take all prescription medicines, OTC products, supplements and actual packs for pharmacist or prescriber review." }, { "zh": "这份美国公开标签的机制资料不能建立中国大陆、欧盟、日本或其他市场的产品状态，也不能替代当前说明书、血压监测计划或个体化治疗。", "en": "This U.S. public label's mechanism material does not establish product status in Mainland China, the EU, Japan or another market and cannot replace a current leaflet, blood-pressure monitoring plan or individualised care." } ], "source": { "id": "src_44ef083a89cdfd0e", "label": "DailyMed（NLM）：BENICAR 奥美沙坦酯美国公开标签（Clinical Pharmacology）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=5b6f8a18-8f8a-4521-81c3-3a39c73c6646", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "Benicar", "generic": "奥美沙坦酯", "dosageFormClass": "奥美沙坦酯口服薄膜衣片：5 mg、20 mg、40 mg（美国公开标签所列；各 30 片瓶装）" }, "labelSource": { "id": "src_44ef083a89cdfd0e", "label": "DailyMed（NLM）：BENICAR 奥美沙坦酯美国公开标签（Cosette；2023-07 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=5b6f8a18-8f8a-4521-81c3-3a39c73c6646", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "productRoutes": [ { "source": { "id": "src_44ef083a89cdfd0e", "label": "DailyMed（NLM）：BENICAR 奥美沙坦酯美国公开标签（Cosette；2023-07 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=5b6f8a18-8f8a-4521-81c3-3a39c73c6646", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-23", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-23", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "DailyMed 的 BENICAR（olmesartan medoxomil）公开标签列有 5 mg、20 mg、40 mg 口服薄膜衣片、各自 30 片瓶装、NDC 与片剂外观线索。本页帮助读者把药盒上的品牌、通用名、每片标示量和公开电子说明书放在一起核对；不把 mg、包装数字、颜色或“降压药”类别转换为个人片数、开始、加减、联用、替换、停用或购买结论。", "history": "该档案以 DailyMed 的 BENICAR 美国公开标签为产品身份锚点。标签列示 Initial U.S. Approval: 2002，并列有 5 mg（NDC 0713-0860-30）、20 mg（NDC 0713-0861-30）、40 mg（NDC 0713-0862-30）各 30 片瓶装。相同通用名、相近 mg、颜色、瓶装数量或同为血压相关药物，都不能证明可自行换用、叠加、拆分、补用或改变任何现有治疗。", "sourceDocuments": [ { "id": "src_44ef083a89cdfd0e", "label": "DailyMed（NLM）：BENICAR 奥美沙坦酯美国公开标签（Cosette；2023-07 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=5b6f8a18-8f8a-4521-81c3-3a39c73c6646", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, { "id": "src_5ed30b676fbb9773", "label": "FDA Drugs@FDA 官方检索入口（BENICAR）", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_lookup_entry", "documentKind": "regulatory_lookup", "market": "US", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } ], "applicationNumber": "DailyMed 美国公开标签列有 Initial U.S. Approval: 2002（本档案不另行断言申请号）", "approvalTimeline": [ { "date": "2002", "title": { "zh": "FDA 标签所列美国初始批准年份", "en": "Initial U.S. approval year listed in the FDA label" }, "detail": { "zh": "本页链接的 FDA 标签档案列示 Initial U.S. Approval: 2002。该历史定位不等同于当前批准、可得性、持有人或其他市场状态。", "en": "The FDA label archive linked here lists Initial U.S. Approval: 2002. This historical locator is not a conclusion about current approval, availability, holder or another market." }, "source": { "id": "src_44ef083a89cdfd0e", "label": "DailyMed: BENICAR olmesartan medoxomil U.S. public label", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=5b6f8a18-8f8a-4521-81c3-3a39c73c6646", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" } }, { "date": "2023-07 updated public label", "title": { "zh": "FDA 标签档案版本", "en": "FDA label archive version" }, "detail": { "zh": "本页链接 2023-07 updated public label 的 FDA 标签档案作为可复核阅读入口。现行标签、规格、适应症和安全信息必须另行以目标市场当前文件核对。", "en": "This page links the 2023-07 updated public label FDA label archive as a traceable reading entry point. Current labeling, strength, indication and safety information require separate verification against the target market’s current document." }, "source": { "id": "src_44ef083a89cdfd0e", "label": "DailyMed: BENICAR olmesartan medoxomil U.S. public label", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=5b6f8a18-8f8a-4521-81c3-3a39c73c6646", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "已链接公开标签档案", "en": "Public label archive linked" }, "detail": { "zh": "仅对应本页所列 FDA 文件。", "en": "Only the FDA document listed on this page is linked." } }, { "market": { "zh": "中国大陆、欧盟、日本", "en": "Mainland China, EU, Japan" }, "status": { "zh": "待逐项建立市场记录", "en": "Market record not established" }, "detail": { "zh": "不从美国标签档案推定当地批准、持有人、规格、供应或可售资格。", "en": "No local approval, holder, strength, supply or sale-eligibility conclusion is inferred from the U.S. label archive." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "标签档案能代表现在的产品信息吗？", "en": "Does a label archive represent current product information?" }, "answer": { "zh": "不能自动代表。档案用于定位来源；需要以目标市场的现行官方标签逐项复核。", "en": "Not automatically. The archive locates a source; each point needs verification against the target market’s current official label." } }, { "question": { "zh": "为什么这里不展示价格或原研/仿制结论？", "en": "Why are price and originator/generic conclusions not shown?" }, "answer": { "zh": "这些结论需要产品、剂型、规格、包装、市场、日期和原始记录分别齐全并经人工审核；单一标签文件不足以支持。", "en": "Those conclusions require separately complete and human-reviewed product, dosage-form, strength, pack, market, date and primary-record fields; one label file is insufficient." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "how-to-read-a-drug-label", "regulatory-sources-first" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/benicar/", "en": "https://origindrug.com/en/drugs/benicar/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "diovan", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-31", "status": "published_traceable_archive" }, "names": { "brand": "Diovan", "generic": "缬沙坦", "aliases": [ "DIOVAN", "代文", "valsartan", "缬沙坦", "缬沙坦胶囊" ], "marketBrandNames": [ { "name": "代文", "market": { "zh": "中国大陆（2026 政府公开价格记录）", "en": "Mainland China (2026 government public price record)" }, "evidenceStatus": "dated_public_record", "note": { "zh": "济宁市政府 2026 年公开页面列有代文胶囊／缬沙坦胶囊 80 mg×7 粒、北京诺华。该记录只建立中文名称、通用名、胶囊剂型和有日期规格线索；不替代 NMPA 当前批准、说明书、准确包装、库存或可售资格核验，也不与美国 DIOVAN 片剂包装合并。", "en": "A 2026 Jining government public page lists 代文 capsules / valsartan capsules, 80 mg × 7, Beijing Novartis. It establishes only a Chinese name, generic name, capsule form and dated strength/pack cue; it does not replace a current NMPA approval, leaflet, exact pack, stock or sale-eligibility check and is not merged with U.S. DIOVAN tablet packs." }, "source": { "id": "src_6886ccd150c2c1fd", "label": "济宁市政府：2026 年药品价格页面列示代文胶囊／缬沙坦胶囊 80 mg×7 粒（有日期名称与剂型线索）", "url": "https://dlrk.jining.gov.cn/art/2026/4/28/art_91842_2879444.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "government_price_record", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-31", "reviewedAt": "2026-08-31" } } ], "mainlandChinaTradeNameCue": { "value": "代文®", "status": "discovery_cue_requires_target_market_verification", "source": { "id": "src_6886ccd150c2c1fd", "label": "济宁市人民政府：2026 年药品价格公开记录中的代文／缬沙坦胶囊 80 mg 记录", "url": "https://dlrk.jining.gov.cn/art/2026/4/28/art_91842_2879444.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "government_medicine_listing", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-12", "reviewedAt": "2026-09-12" } } }, "identity": { "therapeuticArea": "心血管", "sourceArchiveMarket": "美国 DailyMed 有日期公开标签（页面 2026-08-11 更新；本档案分别展示七个准确包装面板）；中国大陆政府公开记录中的‘代文’仅作为缬沙坦胶囊中文商品名线索，与美国 DIOVAN 片剂身份分开", "dosageFormClass": "美国：缬沙坦口服薄膜衣片 40 mg、80 mg、160 mg、320 mg；中国大陆有日期政府记录：代文缬沙坦胶囊 80 mg（仅名称/剂型线索，不并入美国片剂包装）", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "1996（FDA 标签所列美国初始批准）", "archiveSponsorText": "FDA / DailyMed 公开监管标签档案" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [ "DIOVAN HCT", "EXFORGE", "EXFORGE HCT", "ENTRESTO", "valsartan hydrochlorothiazide", "sacubitril valsartan", "氯沙坦钾氢氯噻嗪", "氨氯地平缬沙坦", "沙库巴曲缬沙坦" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-diovan-valsartan-tablet-40mg-0078042315", "marketCode": "US", "labelVersion": { "zh": "DailyMed 页面 2026-08-11 更新的公开标签", "en": "public DailyMed label page updated 11 Aug 2026" }, "dosageForm": { "zh": "DIOVAN 缬沙坦口服薄膜衣片", "en": "DIOVAN valsartan oral film-coated tablet" }, "route": { "zh": "口服（仅作标签产品身份字段）", "en": "oral (label product-identity field only)" }, "routeCodes": [ "oral" ], "productCode": "NDC 0078-0423-15", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片 40 mg；30 片瓶装", "en": "40 mg per tablet; 30-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=5ddba454-f3e6-43c2-a7a6-58365d297213&name=diovan-tablets-03.jpg", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "缬沙坦", "en": "valsartan" }, "value": 40, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人服用片数、加减、补服、换药或换算指令", "en": "labelled amount per tablet; not an individual tablet count, adjustment, make-up, switching or conversion instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "塑料瓶", "en": "plastic bottle" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-21", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 30, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "黄色", "en": "yellow" }, "shape": { "zh": "椭圆形、斜切边", "en": "ovaloid with beveled edges" }, "imprint": "NVR / DO", "scoreStatus": "scored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_63346904b9b78608", "label": "DailyMed（NLM）：DIOVAN 缬沙坦 40 mg、30 片瓶装美国公开标签面板（Novartis；页面 2026-08-11 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=5ddba454-f3e6-43c2-a7a6-58365d297213", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-diovan-valsartan-tablet-80mg-0078035834", "marketCode": "US", "labelVersion": { "zh": "DailyMed 页面 2026-08-11 更新的公开标签", "en": "public DailyMed label page updated 11 Aug 2026" }, "dosageForm": { "zh": "DIOVAN 缬沙坦口服薄膜衣片", "en": "DIOVAN valsartan oral film-coated tablet" }, "route": { "zh": "口服（仅作标签产品身份字段）", "en": "oral (label product-identity field only)" }, "routeCodes": [ "oral" ], "productCode": "NDC 0078-0358-34", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片 80 mg；90 片瓶装", "en": "80 mg per tablet; 90-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=5ddba454-f3e6-43c2-a7a6-58365d297213&name=diovan-tablets-04.jpg", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "缬沙坦", "en": "valsartan" }, "value": 80, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人服用片数、加减、补服、换药或换算指令", "en": "labelled amount per tablet; not an individual tablet count, adjustment, make-up, switching or conversion instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "塑料瓶", "en": "plastic bottle" }, "fill": null, "countPerPackage": 90, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-21", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 90, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "浅红色", "en": "pale red" }, "shape": { "zh": "圆形、斜切边", "en": "round with beveled edges" }, "imprint": "NVR / DV", "scoreStatus": "scored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_63346904b9b78608", "label": "DailyMed（NLM）：DIOVAN 缬沙坦 80 mg、90 片瓶装美国公开标签面板（Novartis；页面 2026-08-11 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=5ddba454-f3e6-43c2-a7a6-58365d297213", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-diovan-valsartan-tablet-80mg-0078124534", "marketCode": "US", "labelVersion": { "zh": "DailyMed 页面 2026-08-11 更新的公开标签", "en": "public DailyMed label page updated 11 Aug 2026" }, "dosageForm": { "zh": "DIOVAN 缬沙坦口服薄膜衣片", "en": "DIOVAN valsartan oral film-coated tablet" }, "route": { "zh": "口服（仅作标签产品身份字段）", "en": "oral (label product-identity field only)" }, "routeCodes": [ "oral" ], "productCode": "NDC 0078-1245-34", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片 80 mg；90 片瓶装", "en": "80 mg per tablet; 90-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=5ddba454-f3e6-43c2-a7a6-58365d297213&name=diovan-tablets-07.jpg", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "缬沙坦", "en": "valsartan" }, "value": 80, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人服用片数、加减、补服、换药或换算指令", "en": "labelled amount per tablet; not an individual tablet count, adjustment, make-up, switching or conversion instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "塑料瓶", "en": "plastic bottle" }, "fill": null, "countPerPackage": 90, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-21", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 90, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "浅红色", "en": "pale red" }, "shape": { "zh": "圆形、斜切边", "en": "round with beveled edges" }, "imprint": "NVR / DV", "scoreStatus": "scored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_63346904b9b78608", "label": "DailyMed（NLM）：DIOVAN 缬沙坦 80 mg、90 片瓶装美国公开标签面板（Novartis；页面 2026-08-11 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=5ddba454-f3e6-43c2-a7a6-58365d297213", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-diovan-valsartan-tablet-160mg-0078035934", "marketCode": "US", "labelVersion": { "zh": "DailyMed 页面 2026-08-11 更新的公开标签", "en": "public DailyMed label page updated 11 Aug 2026" }, "dosageForm": { "zh": "DIOVAN 缬沙坦口服薄膜衣片", "en": "DIOVAN valsartan oral film-coated tablet" }, "route": { "zh": "口服（仅作标签产品身份字段）", "en": "oral (label product-identity field only)" }, "routeCodes": [ "oral" ], "productCode": "NDC 0078-0359-34", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片 160 mg；90 片瓶装", "en": "160 mg per tablet; 90-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=5ddba454-f3e6-43c2-a7a6-58365d297213&name=diovan-tablets-05.jpg", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "缬沙坦", "en": "valsartan" }, "value": 160, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人服用片数、加减、补服、换药或换算指令", "en": "labelled amount per tablet; not an individual tablet count, adjustment, make-up, switching or conversion instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "塑料瓶", "en": "plastic bottle" }, "fill": null, "countPerPackage": 90, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-21", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 90, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "灰橙色", "en": "grey-orange" }, "shape": { "zh": "椭圆形、斜切边", "en": "ovaloid with beveled edges" }, "imprint": "NVR / DX", "scoreStatus": "scored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_63346904b9b78608", "label": "DailyMed（NLM）：DIOVAN 缬沙坦 160 mg、90 片瓶装美国公开标签面板（Novartis；页面 2026-08-11 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=5ddba454-f3e6-43c2-a7a6-58365d297213", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-diovan-valsartan-tablet-160mg-0078125234", "marketCode": "US", "labelVersion": { "zh": "DailyMed 页面 2026-08-11 更新的公开标签", "en": "public DailyMed label page updated 11 Aug 2026" }, "dosageForm": { "zh": "DIOVAN 缬沙坦口服薄膜衣片", "en": "DIOVAN valsartan oral film-coated tablet" }, "route": { "zh": "口服（仅作标签产品身份字段）", "en": "oral (label product-identity field only)" }, "routeCodes": [ "oral" ], "productCode": "NDC 0078-1252-34", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片 160 mg；90 片瓶装", "en": "160 mg per tablet; 90-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=5ddba454-f3e6-43c2-a7a6-58365d297213&name=diovan-tablets-08.jpg", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "缬沙坦", "en": "valsartan" }, "value": 160, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人服用片数、加减、补服、换药或换算指令", "en": "labelled amount per tablet; not an individual tablet count, adjustment, make-up, switching or conversion instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "塑料瓶", "en": "plastic bottle" }, "fill": null, "countPerPackage": 90, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-21", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 90, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "灰橙色", "en": "grey-orange" }, "shape": { "zh": "椭圆形、斜切边", "en": "ovaloid with beveled edges" }, "imprint": "NVR / DX", "scoreStatus": "scored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_63346904b9b78608", "label": "DailyMed（NLM）：DIOVAN 缬沙坦 160 mg、90 片瓶装美国公开标签面板（Novartis；页面 2026-08-11 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=5ddba454-f3e6-43c2-a7a6-58365d297213", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-diovan-valsartan-tablet-320mg-0078036034", "marketCode": "US", "labelVersion": { "zh": "DailyMed 页面 2026-08-11 更新的公开标签", "en": "public DailyMed label page updated 11 Aug 2026" }, "dosageForm": { "zh": "DIOVAN 缬沙坦口服薄膜衣片", "en": "DIOVAN valsartan oral film-coated tablet" }, "route": { "zh": "口服（仅作标签产品身份字段）", "en": "oral (label product-identity field only)" }, "routeCodes": [ "oral" ], "productCode": "NDC 0078-0360-34", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片 320 mg；90 片瓶装", "en": "320 mg per tablet; 90-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=5ddba454-f3e6-43c2-a7a6-58365d297213&name=diovan-tablets-06.jpg", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "缬沙坦", "en": "valsartan" }, "value": 320, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人服用片数、加减、补服、换药或换算指令", "en": "labelled amount per tablet; not an individual tablet count, adjustment, make-up, switching or conversion instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "塑料瓶", "en": "plastic bottle" }, "fill": null, "countPerPackage": 90, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-21", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 90, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "深灰紫色", "en": "dark grey-violet" }, "shape": { "zh": "椭圆形、斜切边", "en": "ovaloid with beveled edges" }, "imprint": "NVR / DXL", "scoreStatus": "scored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_63346904b9b78608", "label": "DailyMed（NLM）：DIOVAN 缬沙坦 320 mg、90 片瓶装美国公开标签面板（Novartis；页面 2026-08-11 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=5ddba454-f3e6-43c2-a7a6-58365d297213", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-diovan-valsartan-tablet-320mg-0078125934", "marketCode": "US", "labelVersion": { "zh": "DailyMed 页面 2026-08-11 更新的公开标签", "en": "public DailyMed label page updated 11 Aug 2026" }, "dosageForm": { "zh": "DIOVAN 缬沙坦口服薄膜衣片", "en": "DIOVAN valsartan oral film-coated tablet" }, "route": { "zh": "口服（仅作标签产品身份字段）", "en": "oral (label product-identity field only)" }, "routeCodes": [ "oral" ], "productCode": "NDC 0078-1259-34", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片 320 mg；90 片瓶装", "en": "320 mg per tablet; 90-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=5ddba454-f3e6-43c2-a7a6-58365d297213&name=diovan-tablets-09.jpg", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "缬沙坦", "en": "valsartan" }, "value": 320, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人服用片数、加减、补服、换药或换算指令", "en": "labelled amount per tablet; not an individual tablet count, adjustment, make-up, switching or conversion instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "塑料瓶", "en": "plastic bottle" }, "fill": null, "countPerPackage": 90, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-21", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 90, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "深灰紫色", "en": "dark grey-violet" }, "shape": { "zh": "椭圆形、斜切边", "en": "ovaloid with beveled edges" }, "imprint": "NVR / DXL", "scoreStatus": "scored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_63346904b9b78608", "label": "DailyMed（NLM）：DIOVAN 缬沙坦 320 mg、90 片瓶装美国公开标签面板（Novartis；页面 2026-08-11 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=5ddba454-f3e6-43c2-a7a6-58365d297213", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-diovan-valsartan-tablet-40mg-0078042315", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=diovan-tablets-03.jpg&setid=5ddba454-f3e6-43c2-a7a6-58365d297213&type=img", "alt": "DIOVAN 40 mg 缬沙坦片在美国 DailyMed 公开标签中的 30 片瓶装主展示图", "archiveMarket": "美国", "labelVersion": "2026-08", "presentation": "DIOVAN 40 mg 缬沙坦、NDC 0078-0423-15、30 片瓶装主展示面（DailyMed 页面 2026-08-11 更新标签）", "notice": "此为美国 DailyMed 公开标签中的包装文字图，只帮助核对 DIOVAN、通用名、标示强度、NDC 和口服片剂线索；不用于鉴定真伪，也不证明原研身份、当前包装、目标市场批准或可售资格。", "source": { "id": "src_63346904b9b78608", "label": "DailyMed（NLM）：DIOVAN 公开标签（2026-08-11 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=5ddba454-f3e6-43c2-a7a6-58365d297213", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "DIOVAN 说明书放大阅读：不同 mg 与同类降压药不能靠名称自行拼用", "en": "DIOVAN label reading: different mg strengths and related blood-pressure medicines are not for self-combining" }, "summary": { "zh": "本模块以 DailyMed 2026-08 美国公开标签为阅读入口，帮助核对 DIOVAN、缬沙坦、口服片剂、不同 mg 和片剂外观；它不把标签数字转换为个人剂量、联用、停药或换药方案。", "en": "This module uses the Aug 2026 U.S. DailyMed public label as a reading entry point. It helps check DIOVAN, valsartan, oral tablets, different mg markings and tablet appearance; it does not turn label numbers into an individual dose, combination, stop or switch plan." }, "checks": [ { "zh": "公开标签列有 40、80、160、320 mg 片剂。每个数字首先是该片的标示强度；不同 mg、不同市场或不同包装不能自行拼成“今天该吃几片”的答案，应以实际处方和现行标签为准。", "en": "The public label lists 40, 80, 160 and 320 mg tablets. Each number first identifies that tablet's stated strength; different mg markings, markets or packs cannot be self-combined into an answer for how many tablets to take today. Use the actual prescription and current label." }, { "zh": "片剂的颜色、形状或刻字是辅助核对线索，不是验证真伪、判断可替代性或决定能否掰开、研碎的依据。涉及实际药盒时，应让药师核对该市场、该版本和该规格的现行资料。", "en": "Tablet colour, shape or debossing are supporting checks, not a way to authenticate a medicine, establish interchangeability, or decide whether it may be split or crushed. For an actual pack, ask a pharmacist to check current information for that market, version and strength." }, { "zh": "标签提示肾功能变化、血钾、锂盐、非甾体抗炎药及其他作用于肾素-血管紧张素系统的药物需要核对。止痛药、补充剂、其他降压药和完整药单都应一并交给药师或医生；网页不能给出个人“能不能同服”的结论。", "en": "The label identifies kidney-function changes, potassium, lithium, non-steroidal anti-inflammatory medicines and other medicines acting on the renin-angiotensin system as items needing review. Pain medicines, supplements, other blood-pressure medicines and the complete medicine list should be shown together to a pharmacist or clinician; a webpage cannot give an individual answer about taking them together." }, { "zh": "怀孕、近期脱水、肾功能或其他健康状况变化，都可能改变需要由专业人员复核的内容。不要因血压读数、剩余药片或包装变化自行停用、加量、交替或改用另一种同类药。", "en": "Pregnancy, recent dehydration, kidney-function changes or other health changes can alter what needs professional review. Do not self-stop, increase, alternate or substitute another related medicine because of a blood-pressure reading, remaining tablets or a package change." } ], "source": { "id": "src_63346904b9b78608", "label": "DailyMed（NLM）：DIOVAN 公开标签（2026-08-11 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=5ddba454-f3e6-43c2-a7a6-58365d297213", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "缬沙坦怎样起作用：它阻断血管紧张素 II 的 AT₁ 受体", "en": "How valsartan works: it blocks the AT1 receptor for angiotensin II" }, "summary": { "zh": "FDA 标签将 DIOVAN 描述为选择性血管紧张素 II AT₁ 受体阻滞剂。它阻断血管紧张素 II 在相关组织与 AT₁ 受体的结合，从而影响血管收缩和醛固酮分泌相关通路。这个机制不决定个人血压、肾功能、血钾、剂量或是否应换药。", "en": "The FDA label describes DIOVAN as a selective angiotensin II AT1-receptor blocker. It blocks angiotensin II binding at AT1 receptors in relevant tissues, affecting pathways related to vasoconstriction and aldosterone secretion. This mechanism does not decide an individual's blood pressure, kidney function, potassium, dose or whether to switch medicines." }, "checks": [ { "zh": "与氯沙坦或其他 ARB 共享 AT₁ 受体机制，不表示两者可自行同服、隔日轮换、按 mg 换算或以“哪个更强”决定替换。任何转换或联合问题都需把实际产品、完整药单和病史交由专业人员核对。", "en": "Sharing an AT1-receptor mechanism with losartan or another ARB does not make products self-combinable, alternatable on different days, convertible by mg or replaceable by deciding which is “stronger.” Any switching or combination question needs the actual products, complete medicine list and history reviewed by professionals." }, { "zh": "机制不能把 40、80、160、320 mg 或药片外观变成个人加量、减量、掰开或停药的依据。药品数字先是产品身份线索；具体用法必须回到现行标签和个人处方。", "en": "Mechanism cannot turn 40, 80, 160 or 320 mg, or tablet appearance, into a basis for personal increase, reduction, splitting or stopping. Product numbers are first identity clues; specific use must return to the current label and individual prescription." }, { "zh": "脱水、肾功能或血钾变化、怀孕，以及同时使用止痛药、补充剂、锂盐或其他影响肾素-血管紧张素系统的药物时，不能从本页给出个人处理结论。出现晕厥、明显不适或其他新问题，应使用当地医疗支持。", "en": "With dehydration, kidney-function or potassium changes, pregnancy, or concurrent pain medicines, supplements, lithium or another medicine affecting the renin-angiotensin system, this page cannot give an individual management conclusion. With fainting, marked discomfort or another new concern, use local medical support." } ], "source": { "id": "src_809fb1049996c290", "label": "FDA：DIOVAN 2021 美国处方信息（临床药理）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021283s058lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "Diovan", "generic": "缬沙坦", "dosageFormClass": "美国：缬沙坦口服薄膜衣片 40 mg、80 mg、160 mg、320 mg；中国大陆有日期政府记录：代文缬沙坦胶囊 80 mg（仅名称/剂型线索，不并入美国片剂包装）" }, "labelSource": { "id": "src_63346904b9b78608", "label": "DailyMed（NLM）：DIOVAN 公开标签（2026-08-11 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=5ddba454-f3e6-43c2-a7a6-58365d297213", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "productRoutes": [ { "source": { "id": "src_63346904b9b78608", "label": "DailyMed（NLM）：DIOVAN 公开标签（2026-08-11 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=5ddba454-f3e6-43c2-a7a6-58365d297213", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_809fb1049996c290", "label": "FDA：DIOVAN 2021 美国处方信息（NDA 021283）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021283s058lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "美国 DailyMed 的 DIOVAN（valsartan）有日期公开标签列有 40、80、160、320 mg 口服薄膜衣片；本页分别建立七个准确包装面板的品牌、通用名、每片强度、NDC、外观线索和来源核对卡。它不把包装数字变成个人片数、加减、补服、停用、换药或联用方案，也不据此推定原研关系、目标市场批准、供应或销售资格。", "history": "FDA 历史标签记录其美国初始批准年份为 1996。本页的七个包装面板只对应 DailyMed 页面 2026-08-11 更新时所列的 DIOVAN 单方缬沙坦 40 mg、80 mg、160 mg、320 mg 瓶装。济宁市政府 2026 年公开药品价格页面列有‘代文胶囊-缬沙坦胶囊 80 mg×7 粒/盒、北京诺华’，这里只用作中文名称和胶囊剂型检索线索，不把它冒充美国片剂包装、NMPA 当前记录、库存或购买结论；DIOVAN HCT、EXFORGE、EXFORGE HCT、ENTRESTO 等复方也不能并入本单方档案。", "sourceDocuments": [ { "id": "src_809fb1049996c290", "label": "FDA：DIOVAN 2021 美国处方信息（NDA 021283）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021283s058lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_63346904b9b78608", "label": "DailyMed（NLM）：DIOVAN 公开标签（2026-08-11 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=5ddba454-f3e6-43c2-a7a6-58365d297213", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_5ed30b676fbb9773", "label": "FDA Drugs@FDA 官方检索入口", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_lookup_entry", "documentKind": "regulatory_lookup", "market": "US", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_6886ccd150c2c1fd", "label": "济宁市政府：2026 年药品价格页面列示代文胶囊／缬沙坦胶囊 80 mg×7 粒（有日期名称与剂型线索）", "url": "https://dlrk.jining.gov.cn/art/2026/4/28/art_91842_2879444.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "government_price_record", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-31", "reviewedAt": "2026-08-31" } ], "applicationNumber": "NDA 021283", "approvalTimeline": [ { "date": "1996", "title": { "zh": "FDA 标签所列美国初始批准年份", "en": "Initial U.S. approval year listed in the FDA label" }, "detail": { "zh": "本页链接的 FDA 标签档案列示 Initial U.S. Approval: 1996。该历史定位不等同于当前批准、可得性、持有人或其他市场状态。", "en": "The FDA label archive linked here lists Initial U.S. Approval: 1996. This historical locator is not a conclusion about current approval, availability, holder or another market." }, "source": { "id": "src_809fb1049996c290", "label": "FDA: DIOVAN prescribing information", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021283s058lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, { "date": "2021", "title": { "zh": "FDA 标签档案版本", "en": "FDA label archive version" }, "detail": { "zh": "本页链接 2021 的 FDA 标签档案作为可复核阅读入口。现行标签、规格、适应症和安全信息必须另行以目标市场当前文件核对。", "en": "This page links the 2021 FDA label archive as a traceable reading entry point. Current labeling, strength, indication and safety information require separate verification against the target market’s current document." }, "source": { "id": "src_809fb1049996c290", "label": "FDA: DIOVAN prescribing information", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021283s058lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "已链接公开标签档案", "en": "Public label archive linked" }, "detail": { "zh": "仅对应本页所列 FDA 文件。", "en": "Only the FDA document listed on this page is linked." } }, { "market": { "zh": "中国大陆、欧盟、日本", "en": "Mainland China, EU, Japan" }, "status": { "zh": "待逐项建立市场记录", "en": "Market record not established" }, "detail": { "zh": "不从美国标签档案推定当地批准、持有人、规格、供应或可售资格。", "en": "No local approval, holder, strength, supply or sale-eligibility conclusion is inferred from the U.S. label archive." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "标签档案能代表现在的产品信息吗？", "en": "Does a label archive represent current product information?" }, "answer": { "zh": "不能自动代表。档案用于定位来源；需要以目标市场的现行官方标签逐项复核。", "en": "Not automatically. The archive locates a source; each point needs verification against the target market’s current official label." } }, { "question": { "zh": "为什么这里不展示价格或原研/仿制结论？", "en": "Why are price and originator/generic conclusions not shown?" }, "answer": { "zh": "这些结论需要产品、剂型、规格、包装、市场、日期和原始记录分别齐全并经人工审核；单一标签文件不足以支持。", "en": "Those conclusions require separately complete and human-reviewed product, dosage-form, strength, pack, market, date and primary-record fields; one label file is insufficient." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "how-to-read-a-drug-label", "regulatory-sources-first" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/diovan/", "en": "https://origindrug.com/en/drugs/diovan/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "exforge", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-21", "status": "published_traceable_archive" }, "names": { "brand": "Exforge", "generic": "氨氯地平/缬沙坦", "aliases": [ "EXFORGE", "amlodipine and valsartan", "amlodipine/valsartan", "氨氯地平/缬沙坦" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "心血管", "sourceArchiveMarket": "美国当前 EXFORGE 氨氯地平/缬沙坦公开标签（DailyMed SPL v36：2026-02-17 生效/更新，2026-02-18 发布）", "dosageFormClass": "口服薄膜衣片：氨氯地平/缬沙坦 5/160、10/160、5/320、10/320 mg（当前美国标签所列）", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "2007（当前美国标签所列 Initial U.S. Approval）", "archiveSponsorText": "Novartis Pharmaceuticals Corporation / DailyMed（NLM）当前公开标签档案" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [ "EXFORGE HCT", "hydrochlorothiazide", "氢氯噻嗪" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-exforge-amlodipine-5mg-valsartan-160mg-30-tablet-bottle-ndc-0078-0488-15", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v36；2026-02-17 生效/更新，2026-02-18 发布", "en": "DailyMed SPL v36; effective/updated 17 Feb 2026 and published 18 Feb 2026" }, "dosageForm": { "zh": "氨氯地平/缬沙坦口服薄膜衣片", "en": "amlodipine/valsartan oral film-coated tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 0078-0488-15", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片：氨氯地平 5 mg + 缬沙坦 160 mg；30 片瓶装", "en": "Per tablet: amlodipine 5 mg + valsartan 160 mg; 30-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=d0caec89-96ec-411d-a933-63eda74a6da7&name=exforge-07.jpg", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "氨氯地平", "en": "amlodipine" }, "value": 5, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签量；不是个人片数或调药规则", "en": "labelled amount per tablet; not an individual's tablet count or adjustment rule" } }, { "ingredient": { "zh": "缬沙坦", "en": "valsartan" }, "value": 160, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签量；不是个人片数或调药规则", "en": "labelled amount per tablet; not an individual's tablet count or adjustment rule" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "儿童安全瓶装", "en": "child-resistant bottle" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-21", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 30, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "深黄色", "en": "dark yellow" }, "shape": { "zh": "椭圆形、有斜边薄膜衣片", "en": "ovaloid, bevel-edged film-coated tablet" }, "imprint": "NVR / ECE", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_5b99fe84908369a0", "label": "DailyMed（NLM）：EXFORGE 氨氯地平/缬沙坦当前美国公开标签（Novartis；SPL v36）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=d0caec89-96ec-411d-a933-63eda74a6da7&version=36", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-exforge-amlodipine-10mg-valsartan-160mg-30-tablet-bottle-ndc-0078-0489-15", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v36；2026-02-17 生效/更新，2026-02-18 发布", "en": "DailyMed SPL v36; effective/updated 17 Feb 2026 and published 18 Feb 2026" }, "dosageForm": { "zh": "氨氯地平/缬沙坦口服薄膜衣片", "en": "amlodipine/valsartan oral film-coated tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 0078-0489-15", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片：氨氯地平 10 mg + 缬沙坦 160 mg；30 片瓶装", "en": "Per tablet: amlodipine 10 mg + valsartan 160 mg; 30-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=d0caec89-96ec-411d-a933-63eda74a6da7&name=exforge-08.jpg", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "氨氯地平", "en": "amlodipine" }, "value": 10, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签量；不是个人片数或调药规则", "en": "labelled amount per tablet; not an individual's tablet count or adjustment rule" } }, { "ingredient": { "zh": "缬沙坦", "en": "valsartan" }, "value": 160, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签量；不是个人片数或调药规则", "en": "labelled amount per tablet; not an individual's tablet count or adjustment rule" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "儿童安全瓶装", "en": "child-resistant bottle" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-21", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 30, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "浅黄色", "en": "light yellow" }, "shape": { "zh": "椭圆形、有斜边薄膜衣片", "en": "ovaloid, bevel-edged film-coated tablet" }, "imprint": "NVR / UIC", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_5b99fe84908369a0", "label": "DailyMed（NLM）：EXFORGE 氨氯地平/缬沙坦当前美国公开标签（Novartis；SPL v36）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=d0caec89-96ec-411d-a933-63eda74a6da7&version=36", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-exforge-amlodipine-5mg-valsartan-320mg-30-tablet-bottle-ndc-0078-0490-15", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v36；2026-02-17 生效/更新，2026-02-18 发布", "en": "DailyMed SPL v36; effective/updated 17 Feb 2026 and published 18 Feb 2026" }, "dosageForm": { "zh": "氨氯地平/缬沙坦口服薄膜衣片", "en": "amlodipine/valsartan oral film-coated tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 0078-0490-15", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片：氨氯地平 5 mg + 缬沙坦 320 mg；30 片瓶装", "en": "Per tablet: amlodipine 5 mg + valsartan 320 mg; 30-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=d0caec89-96ec-411d-a933-63eda74a6da7&name=exforge-09.jpg", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "氨氯地平", "en": "amlodipine" }, "value": 5, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签量；不是个人片数或调药规则", "en": "labelled amount per tablet; not an individual's tablet count or adjustment rule" } }, { "ingredient": { "zh": "缬沙坦", "en": "valsartan" }, "value": 320, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签量；不是个人片数或调药规则", "en": "labelled amount per tablet; not an individual's tablet count or adjustment rule" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "儿童安全瓶装", "en": "child-resistant bottle" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-21", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 30, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "深黄色", "en": "very dark yellow" }, "shape": { "zh": "椭圆形、有斜边薄膜衣片", "en": "ovaloid, bevel-edged film-coated tablet" }, "imprint": "NVR / CSF", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_5b99fe84908369a0", "label": "DailyMed（NLM）：EXFORGE 氨氯地平/缬沙坦当前美国公开标签（Novartis；SPL v36）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=d0caec89-96ec-411d-a933-63eda74a6da7&version=36", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-exforge-amlodipine-10mg-valsartan-320mg-30-tablet-bottle-ndc-0078-0491-15", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v36；2026-02-17 生效/更新，2026-02-18 发布", "en": "DailyMed SPL v36; effective/updated 17 Feb 2026 and published 18 Feb 2026" }, "dosageForm": { "zh": "氨氯地平/缬沙坦口服薄膜衣片", "en": "amlodipine/valsartan oral film-coated tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 0078-0491-15", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片：氨氯地平 10 mg + 缬沙坦 320 mg；30 片瓶装", "en": "Per tablet: amlodipine 10 mg + valsartan 320 mg; 30-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=d0caec89-96ec-411d-a933-63eda74a6da7&name=exforge-10.jpg", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "氨氯地平", "en": "amlodipine" }, "value": 10, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签量；不是个人片数或调药规则", "en": "labelled amount per tablet; not an individual's tablet count or adjustment rule" } }, { "ingredient": { "zh": "缬沙坦", "en": "valsartan" }, "value": 320, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签量；不是个人片数或调药规则", "en": "labelled amount per tablet; not an individual's tablet count or adjustment rule" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "儿童安全瓶装", "en": "child-resistant bottle" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-21", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 30, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "深黄色", "en": "dark yellow" }, "shape": { "zh": "椭圆形、有斜边薄膜衣片", "en": "ovaloid, bevel-edged film-coated tablet" }, "imprint": "NVR / LUF", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_5b99fe84908369a0", "label": "DailyMed（NLM）：EXFORGE 氨氯地平/缬沙坦当前美国公开标签（Novartis；SPL v36）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=d0caec89-96ec-411d-a933-63eda74a6da7&version=36", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-exforge-amlodipine-5mg-valsartan-160mg-30-tablet-bottle-ndc-0078-0488-15", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=d0caec89-96ec-411d-a933-63eda74a6da7&name=exforge-07.jpg", "alt": "EXFORGE 氨氯地平/缬沙坦在美国 DailyMed 当前标签中的 5 mg/160 mg、NDC 0078-0488-15、30 片装包装面板", "archiveMarket": "美国", "labelVersion": "DailyMed SPL v36（2026-02-17 生效/更新；2026-02-18 发布）", "presentation": "EXFORGE 氨氯地平/缬沙坦薄膜衣片：每片 5 mg/160 mg；NDC 0078-0488-15；30 片装包装面板。", "notice": "此图只对应美国当前标签中的 EXFORGE 5 mg/160 mg、NDC 0078-0488-15、30 片装。它不代表 10/160、5/320、10/320 mg，EXFORGE HCT 三成分片，单方氨氯地平/缬沙坦，其他包装或其他市场；不用于鉴定真伪，也不生成个人片数、加减量、转换或联合方案。", "source": { "id": "src_5b99fe84908369a0", "label": "DailyMed（NLM）：EXFORGE 氨氯地平/缬沙坦当前美国公开标签（Novartis；SPL v36）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=d0caec89-96ec-411d-a933-63eda74a6da7&version=36", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "EXFORGE 说明书放大阅读：5/160 先是两种成分的每片身份", "en": "EXFORGE label reading: 5/160 first identifies both ingredients in one tablet" }, "summary": { "zh": "本模块以当前美国公开标签为阅读入口，帮助核对 EXFORGE、氨氯地平、缬沙坦、完整双数字、口服薄膜衣片与 NDC。它不决定个人是否需要两种降压成分、每天用几片、能否与其他降压药同用或如何调整。", "en": "This module uses the current U.S. public label to check EXFORGE, amlodipine, valsartan, the complete two-number marking, oral film-coated tablet and NDC. It does not decide whether someone needs both antihypertensive ingredients, a tablet count, co-use with another blood-pressure medicine or an adjustment." }, "checks": [ { "zh": "5/160、10/160、5/320、10/320 mg 都是每片中两种成分的完整标示。不能只看其中一个数字，也不能从数字推导个人每天几片、加减量或把两种单方药自行拼成同一复方。", "en": "5/160, 10/160, 5/320 and 10/320 mg are complete two-ingredient markings per tablet. Do not read only one number, derive a personal tablet count, adjust an amount or self-assemble the fixed combination from two single-ingredient products." }, { "zh": "EXFORGE HCT 另含氢氯噻嗪，是三成分产品；它不是本页的 EXFORGE 双成分片。名称相近、都含氨氯地平或缬沙坦，均不能证明可自行叠加、轮换或替代。", "en": "EXFORGE HCT additionally contains hydrochlorothiazide and is a three-ingredient product; it is not the two-ingredient EXFORGE tablet on this page. Similar names or a shared amlodipine/valsartan ingredient do not establish self-combination, alternation or substitution." }, { "zh": "正在使用其他降压药、利尿剂、含缬沙坦/氯沙坦/厄贝沙坦等产品、止痛药、盐替代品、补充剂或多种药物时，应把实际药盒和完整药单交给药师或医生核对；网页不能把“同类”或“共同成分”变成可否合用的个人结论。", "en": "With another antihypertensive, diuretic, a product containing valsartan/losartan/irbesartan, pain medicine, salt substitute, supplement or multiple medicines, have the actual packs and complete list reviewed by a pharmacist or clinician. A webpage cannot turn a shared class or ingredient into an individual co-use conclusion." }, { "zh": "怀孕/计划妊娠、晕厥、明显头晕、胸痛、呼吸困难、面部或咽喉肿胀等情况需要及时联系当地医生或紧急医疗支持；本页不决定是否自行停用、恢复或改用另一种药。", "en": "Pregnancy/planning pregnancy, fainting, marked dizziness, chest pain, breathing trouble, facial or throat swelling or another acute concern needs timely local clinical or urgent support; this page does not decide self-stopping, restarting or changing to another medicine." } ], "source": { "id": "src_5b99fe84908369a0", "label": "DailyMed（NLM）：EXFORGE 氨氯地平/缬沙坦当前美国公开标签（Novartis；SPL v36）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=d0caec89-96ec-411d-a933-63eda74a6da7&version=36", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "氨氯地平/缬沙坦怎样起作用：标签描述两条不同的降压药理路径", "en": "How amlodipine/valsartan works: the label describes two different antihypertensive pathways" }, "summary": { "zh": "当前标签将 EXFORGE 描述为二氢吡啶类钙通道阻滞剂氨氯地平与血管紧张素 II 受体阻滞剂缬沙坦的固定复方。机制帮助理解为何完整药单核对重要，不预测个人血压、肾功能、血钾、疗效、用量或是否适合换药。", "en": "The current label describes EXFORGE as a fixed combination of the dihydropyridine calcium-channel blocker amlodipine and the angiotensin-II receptor blocker valsartan. Mechanism helps explain why complete-list review matters; it does not predict an individual's blood pressure, kidney function, potassium, response, amount or whether a switch is suitable." }, "checks": [ { "zh": "两个作用路径不表示可把其他钙通道阻滞剂、ARB、ACE 抑制剂或复方降压药自行再加一层。任何新增、停用、轮换或替代都要由掌握完整药单和病史的专业人员核对。", "en": "Two pathways do not mean another calcium-channel blocker, ARB, ACE inhibitor or combination antihypertensive can be self-added. Any addition, stopping, alternation or substitution needs review by a professional with the complete list and history." }, { "zh": "血管紧张素通路、血钾或肾功能等标签词是需要专业复核的线索，不是从家庭血压读数、症状或网络经验自行调整片数的依据。", "en": "Label terms involving the angiotensin pathway, potassium or kidney function are cues for professional review, not grounds to change tablet count from a home blood-pressure reading, symptoms or online experience." }, { "zh": "机制说明不能处理脱水、严重低血压样不适、胸痛、过敏、妊娠相关风险或复杂多药联用。出现急性或严重担忧时应优先使用当地医疗支持。", "en": "A mechanism explanation cannot manage dehydration, severe low-blood-pressure-like symptoms, chest pain, allergy, pregnancy-related risk or complex polypharmacy. With an acute or serious concern, prioritise local medical support." } ], "source": { "id": "src_5b99fe84908369a0", "label": "DailyMed（NLM）：EXFORGE 氨氯地平/缬沙坦当前美国公开标签（Clinical Pharmacology；SPL v36）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=d0caec89-96ec-411d-a933-63eda74a6da7&version=36", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "Exforge", "generic": "氨氯地平/缬沙坦", "dosageFormClass": "口服薄膜衣片：氨氯地平/缬沙坦 5/160、10/160、5/320、10/320 mg（当前美国标签所列）" }, "labelSource": { "id": "src_5b99fe84908369a0", "label": "DailyMed（NLM）：EXFORGE 氨氯地平/缬沙坦当前美国公开标签（Novartis；SPL v36）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=d0caec89-96ec-411d-a933-63eda74a6da7&version=36", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "productRoutes": [ { "source": { "id": "src_5b99fe84908369a0", "label": "DailyMed（NLM）：EXFORGE 氨氯地平/缬沙坦当前美国公开标签（Novartis；SPL v36）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=d0caec89-96ec-411d-a933-63eda74a6da7&version=36", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "DailyMed 当前 EXFORGE 标签将其列为氨氯地平和缬沙坦的固定剂量复方口服片，列有 5/160、10/160、5/320、10/320 mg 四种双成分标示。本页帮助核对品牌、两种成分、完整双数字、实际包装、标签版本和目标市场；不把任何一个数字变成个人片数、加减量、联合、换药或停药方案。", "history": "当前美国标签列示 Initial U.S. Approval: 2007，SPL v36 的 Effective/Updated 日期为 2026-02-17、DailyMed Published 日期为 2026-02-18。EXFORGE HCT 另含氢氯噻嗪，是另一种三成分产品；名称相近、同含氨氯地平或缬沙坦都不建立自行替代或叠加关系。", "sourceDocuments": [ { "id": "src_5b99fe84908369a0", "label": "DailyMed（NLM）：EXFORGE 氨氯地平/缬沙坦当前美国公开标签（Novartis；SPL v36）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=d0caec89-96ec-411d-a933-63eda74a6da7&version=36", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } ], "applicationNumber": "NDA 021990", "approvalTimeline": [ { "date": "2007-06-20", "title": { "zh": "NDA 021990 原始申请批准", "en": "NDA 021990 original application approval" }, "detail": { "zh": "FDA Drugs@FDA 公开记录将 EXFORGE 的原始申请（ORIG 1）标为 2007-06-20 获批；该美国监管节点不建立其他市场的批准、供应或个人适用性。", "en": "The FDA Drugs@FDA public record lists EXFORGE original application (ORIG 1) as approved on 20 Jun 2007. This U.S. regulatory node does not establish approval, supply or individual suitability in another market." }, "source": { "id": "src_37676edf6d98c53b", "label": "FDA: EXFORGE NDA 021990 original approval letter (2007-06-20)", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021990s000ltr.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "approval_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, { "date": "2007", "title": { "zh": "当前标签所列美国初始批准年份", "en": "Initial U.S. approval year listed in the current label" }, "detail": { "zh": "当前 EXFORGE 标签列示 Initial U.S. Approval: 2007；该年份不自动说明其他市场的产品状态。", "en": "The current EXFORGE label lists Initial U.S. Approval: 2007; it does not establish product status in another market." }, "source": { "id": "src_5b99fe84908369a0", "label": "DailyMed: current EXFORGE public label, SPL v36", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=d0caec89-96ec-411d-a933-63eda74a6da7&version=36", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, { "date": "2026-02-17", "title": { "zh": "当前 SPL v36 生效/更新日期", "en": "Current SPL v36 effective/updated date" }, "detail": { "zh": "DailyMed 当前标签的 Effective/Updated 日期为 2026-02-17；该日期与公开日期分开记录。", "en": "The current DailyMed label's effective/updated date is 17 Feb 2026; it remains separate from publication." }, "source": { "id": "src_5b99fe84908369a0", "label": "DailyMed: current EXFORGE public label, SPL v36", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=d0caec89-96ec-411d-a933-63eda74a6da7&version=36", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, { "date": "2026-02-18", "title": { "zh": "DailyMed 公开当前 SPL v36", "en": "DailyMed published current SPL v36" }, "detail": { "zh": "DailyMed 将当前 v36 的 Published Date 列为 2026-02-18；页面不把它解释成个人治疗建议。", "en": "DailyMed lists 18 Feb 2026 as the current v36 Published Date; this page does not interpret it as individual-treatment advice." }, "source": { "id": "src_5b99fe84908369a0", "label": "DailyMed: current EXFORGE public label, SPL v36", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=d0caec89-96ec-411d-a933-63eda74a6da7&version=36", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "已链接当前双成分标签与一个精确包装展示", "en": "Current two-ingredient label and one exact package panel linked" }, "detail": { "zh": "展示图只对应 5 mg/160 mg、NDC 0078-0488-15、30 片装；不据此建立实际在售、库存或其他规格状态。", "en": "The image corresponds only to the 5 mg/160 mg, NDC 0078-0488-15, 30-tablet panel; it does not establish actual marketing, stock or another-strength status." } }, { "market": { "zh": "中国大陆、欧盟、日本及其他市场", "en": "Mainland China, EU, Japan and other markets" }, "status": { "zh": "待逐项建立市场记录", "en": "Market record not established" }, "detail": { "zh": "不从美国标签推定当地商品名、批准、规格、供应、原研关系或可替代性。", "en": "No local trade name, approval, strength, supply, originator relationship or interchangeability is inferred from the U.S. label." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "5/160 mg 是不是只看其中一个数字即可？", "en": "Can 5/160 mg be read as just one of its two numbers?" }, "answer": { "zh": "不能。它表示这一准确复方片中氨氯地平和缬沙坦的两组标示量。页面不把它变成个人片数、调整或与单方药的换算。", "en": "No. It identifies the two labelled ingredient amounts in this exact fixed-combination tablet. The page does not turn it into an individual tablet count, adjustment or conversion to single-ingredient medicines." } }, { "question": { "zh": "EXFORGE 与 EXFORGE HCT 能否自行互换？", "en": "Can EXFORGE and EXFORGE HCT be self-switched?" }, "answer": { "zh": "不能。EXFORGE HCT 另含氢氯噻嗪，是三成分产品。相近品牌名不建立可自行互换关系；请带实际药盒和完整药单咨询药师或开方团队。", "en": "No. EXFORGE HCT additionally contains hydrochlorothiazide and is a three-ingredient product. Similar brand names do not establish self-interchangeability; take the actual packs and complete medicine list to a pharmacist or prescribing team." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "dosage-forms-are-part-of-medicine-identity", "how-to-read-a-drug-label" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/exforge/", "en": "https://origindrug.com/en/drugs/exforge/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "exforge-hct", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-21", "status": "published_traceable_archive" }, "names": { "brand": "Exforge HCT", "generic": "氨氯地平/缬沙坦/氢氯噻嗪", "aliases": [ "EXFORGE HCT", "amlodipine valsartan and hydrochlorothiazide", "amlodipine/valsartan/hydrochlorothiazide", "氨氯地平/缬沙坦/氢氯噻嗪" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "心血管", "sourceArchiveMarket": "美国当前 EXFORGE HCT 氨氯地平/缬沙坦/氢氯噻嗪公开标签（DailyMed SPL v33：2025-12-12 更新，2025-12-15 发布）", "dosageFormClass": "口服薄膜衣片：氨氯地平/缬沙坦/氢氯噻嗪 5/160/12.5、10/160/12.5、5/160/25、10/160/25、10/320/25 mg（当前美国标签所列）", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "2009（当前美国标签所列 Initial U.S. Approval）", "archiveSponsorText": "Novartis Pharmaceuticals Corporation / DailyMed（NLM）当前公开标签档案" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [ "EXFORGE 5/160", "EXFORGE 10/160", "EXFORGE 5/320", "EXFORGE 10/320", "without hydrochlorothiazide", "不含氢氯噻嗪" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-exforge-hct-amlodipine-5mg-valsartan-160mg-hydrochlorothiazide-12-5mg-30-tablet-bottle-ndc-0078-0559-15", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v33；2025-12-12 更新，2025-12-15 发布", "en": "DailyMed SPL v33; updated 12 Dec 2025 and published 15 Dec 2025" }, "dosageForm": { "zh": "氨氯地平/缬沙坦/氢氯噻嗪口服薄膜衣片", "en": "amlodipine/valsartan/hydrochlorothiazide oral film-coated tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 0078-0559-15", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片：氨氯地平 5 mg + 缬沙坦 160 mg + 氢氯噻嗪 12.5 mg；30 片瓶装", "en": "Per tablet: amlodipine 5 mg + valsartan 160 mg + hydrochlorothiazide 12.5 mg; 30-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=18d7820d-471f-4ee2-9ec6-25d8d27c77de&name=exforge-hct-09.jpg", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "氨氯地平", "en": "amlodipine" }, "value": 5, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签量；不是个人片数或调药规则", "en": "labelled amount per tablet; not an individual's tablet count or adjustment rule" } }, { "ingredient": { "zh": "缬沙坦", "en": "valsartan" }, "value": 160, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签量；不是个人片数或调药规则", "en": "labelled amount per tablet; not an individual's tablet count or adjustment rule" } }, { "ingredient": { "zh": "氢氯噻嗪", "en": "hydrochlorothiazide" }, "value": 12.5, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签量；不是个人片数或调药规则", "en": "labelled amount per tablet; not an individual's tablet count or adjustment rule" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "儿童安全瓶装", "en": "child-resistant bottle" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-21", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 30, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_dce8d9494db78945", "label": "DailyMed（NLM）：EXFORGE HCT 氨氯地平/缬沙坦/氢氯噻嗪当前美国公开标签（Novartis；SPL v33）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=18d7820d-471f-4ee2-9ec6-25d8d27c77de&version=33", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-exforge-hct-amlodipine-5mg-valsartan-160mg-hydrochlorothiazide-25mg-30-tablet-bottle-ndc-0078-0560-15", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v33；2025-12-12 更新，2025-12-15 发布", "en": "DailyMed SPL v33; updated 12 Dec 2025 and published 15 Dec 2025" }, "dosageForm": { "zh": "氨氯地平/缬沙坦/氢氯噻嗪口服薄膜衣片", "en": "amlodipine/valsartan/hydrochlorothiazide oral film-coated tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 0078-0560-15", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片：氨氯地平 5 mg + 缬沙坦 160 mg + 氢氯噻嗪 25 mg；30 片瓶装", "en": "Per tablet: amlodipine 5 mg + valsartan 160 mg + hydrochlorothiazide 25 mg; 30-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=18d7820d-471f-4ee2-9ec6-25d8d27c77de&name=exforge-hct-10.jpg", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "氨氯地平", "en": "amlodipine" }, "value": 5, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签量；不是个人片数或调药规则", "en": "labelled amount per tablet; not an individual's tablet count or adjustment rule" } }, { "ingredient": { "zh": "缬沙坦", "en": "valsartan" }, "value": 160, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签量；不是个人片数或调药规则", "en": "labelled amount per tablet; not an individual's tablet count or adjustment rule" } }, { "ingredient": { "zh": "氢氯噻嗪", "en": "hydrochlorothiazide" }, "value": 25, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签量；不是个人片数或调药规则", "en": "labelled amount per tablet; not an individual's tablet count or adjustment rule" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "儿童安全瓶装", "en": "child-resistant bottle" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-21", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 30, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_dce8d9494db78945", "label": "DailyMed（NLM）：EXFORGE HCT 氨氯地平/缬沙坦/氢氯噻嗪当前美国公开标签（Novartis；SPL v33）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=18d7820d-471f-4ee2-9ec6-25d8d27c77de&version=33", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-exforge-hct-amlodipine-10mg-valsartan-160mg-hydrochlorothiazide-12-5mg-30-tablet-bottle-ndc-0078-0561-15", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v33；2025-12-12 更新，2025-12-15 发布", "en": "DailyMed SPL v33; updated 12 Dec 2025 and published 15 Dec 2025" }, "dosageForm": { "zh": "氨氯地平/缬沙坦/氢氯噻嗪口服薄膜衣片", "en": "amlodipine/valsartan/hydrochlorothiazide oral film-coated tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 0078-0561-15", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片：氨氯地平 10 mg + 缬沙坦 160 mg + 氢氯噻嗪 12.5 mg；30 片瓶装", "en": "Per tablet: amlodipine 10 mg + valsartan 160 mg + hydrochlorothiazide 12.5 mg; 30-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=18d7820d-471f-4ee2-9ec6-25d8d27c77de&name=exforge-hct-11.jpg", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "氨氯地平", "en": "amlodipine" }, "value": 10, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签量；不是个人片数或调药规则", "en": "labelled amount per tablet; not an individual's tablet count or adjustment rule" } }, { "ingredient": { "zh": "缬沙坦", "en": "valsartan" }, "value": 160, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签量；不是个人片数或调药规则", "en": "labelled amount per tablet; not an individual's tablet count or adjustment rule" } }, { "ingredient": { "zh": "氢氯噻嗪", "en": "hydrochlorothiazide" }, "value": 12.5, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签量；不是个人片数或调药规则", "en": "labelled amount per tablet; not an individual's tablet count or adjustment rule" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "儿童安全瓶装", "en": "child-resistant bottle" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-21", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 30, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_dce8d9494db78945", "label": "DailyMed（NLM）：EXFORGE HCT 氨氯地平/缬沙坦/氢氯噻嗪当前美国公开标签（Novartis；SPL v33）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=18d7820d-471f-4ee2-9ec6-25d8d27c77de&version=33", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-exforge-hct-amlodipine-10mg-valsartan-160mg-hydrochlorothiazide-25mg-30-tablet-bottle-ndc-0078-0562-15", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v33；2025-12-12 更新，2025-12-15 发布", "en": "DailyMed SPL v33; updated 12 Dec 2025 and published 15 Dec 2025" }, "dosageForm": { "zh": "氨氯地平/缬沙坦/氢氯噻嗪口服薄膜衣片", "en": "amlodipine/valsartan/hydrochlorothiazide oral film-coated tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 0078-0562-15", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片：氨氯地平 10 mg + 缬沙坦 160 mg + 氢氯噻嗪 25 mg；30 片瓶装", "en": "Per tablet: amlodipine 10 mg + valsartan 160 mg + hydrochlorothiazide 25 mg; 30-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=18d7820d-471f-4ee2-9ec6-25d8d27c77de&name=exforge-hct-12.jpg", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "氨氯地平", "en": "amlodipine" }, "value": 10, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签量；不是个人片数或调药规则", "en": "labelled amount per tablet; not an individual's tablet count or adjustment rule" } }, { "ingredient": { "zh": "缬沙坦", "en": "valsartan" }, "value": 160, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签量；不是个人片数或调药规则", "en": "labelled amount per tablet; not an individual's tablet count or adjustment rule" } }, { "ingredient": { "zh": "氢氯噻嗪", "en": "hydrochlorothiazide" }, "value": 25, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签量；不是个人片数或调药规则", "en": "labelled amount per tablet; not an individual's tablet count or adjustment rule" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "儿童安全瓶装", "en": "child-resistant bottle" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-21", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 30, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_dce8d9494db78945", "label": "DailyMed（NLM）：EXFORGE HCT 氨氯地平/缬沙坦/氢氯噻嗪当前美国公开标签（Novartis；SPL v33）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=18d7820d-471f-4ee2-9ec6-25d8d27c77de&version=33", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-exforge-hct-amlodipine-10mg-valsartan-320mg-hydrochlorothiazide-25mg-30-tablet-bottle-ndc-0078-0563-15", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v33；2025-12-12 更新，2025-12-15 发布", "en": "DailyMed SPL v33; updated 12 Dec 2025 and published 15 Dec 2025" }, "dosageForm": { "zh": "氨氯地平/缬沙坦/氢氯噻嗪口服薄膜衣片", "en": "amlodipine/valsartan/hydrochlorothiazide oral film-coated tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 0078-0563-15", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片：氨氯地平 10 mg + 缬沙坦 320 mg + 氢氯噻嗪 25 mg；30 片瓶装", "en": "Per tablet: amlodipine 10 mg + valsartan 320 mg + hydrochlorothiazide 25 mg; 30-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=18d7820d-471f-4ee2-9ec6-25d8d27c77de&name=exforge-hct-13.jpg", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "氨氯地平", "en": "amlodipine" }, "value": 10, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签量；不是个人片数或调药规则", "en": "labelled amount per tablet; not an individual's tablet count or adjustment rule" } }, { "ingredient": { "zh": "缬沙坦", "en": "valsartan" }, "value": 320, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签量；不是个人片数或调药规则", "en": "labelled amount per tablet; not an individual's tablet count or adjustment rule" } }, { "ingredient": { "zh": "氢氯噻嗪", "en": "hydrochlorothiazide" }, "value": 25, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签量；不是个人片数或调药规则", "en": "labelled amount per tablet; not an individual's tablet count or adjustment rule" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "儿童安全瓶装", "en": "child-resistant bottle" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-21", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 30, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_dce8d9494db78945", "label": "DailyMed（NLM）：EXFORGE HCT 氨氯地平/缬沙坦/氢氯噻嗪当前美国公开标签（Novartis；SPL v33）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=18d7820d-471f-4ee2-9ec6-25d8d27c77de&version=33", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-exforge-hct-amlodipine-5mg-valsartan-160mg-hydrochlorothiazide-12-5mg-30-tablet-bottle-ndc-0078-0559-15", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=18d7820d-471f-4ee2-9ec6-25d8d27c77de&name=exforge-hct-09.jpg", "alt": "EXFORGE HCT 氨氯地平/缬沙坦/氢氯噻嗪在美国 DailyMed 当前标签中的 5 mg/160 mg/12.5 mg、NDC 0078-0559-15、30 片装包装面板", "archiveMarket": "美国", "labelVersion": "DailyMed SPL v33（2025-12-12 更新；2025-12-15 发布）", "presentation": "EXFORGE HCT 氨氯地平/缬沙坦/氢氯噻嗪薄膜衣片：每片 5 mg/160 mg/12.5 mg；NDC 0078-0559-15；30 片装包装面板。", "notice": "此图只对应美国当前标签中的 EXFORGE HCT 5 mg/160 mg/12.5 mg、NDC 0078-0559-15、30 片装。它不代表其余四种 EXFORGE HCT 强度、EXFORGE 双成分片、单方成分、其他包装或其他市场；不用于鉴定真伪，也不生成个人片数、加减量、转换或联合方案。", "source": { "id": "src_dce8d9494db78945", "label": "DailyMed（NLM）：EXFORGE HCT 氨氯地平/缬沙坦/氢氯噻嗪当前美国公开标签（Novartis；SPL v33）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=18d7820d-471f-4ee2-9ec6-25d8d27c77de&version=33", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "EXFORGE HCT 说明书放大阅读：5/160/12.5 是三种成分的每片身份", "en": "EXFORGE HCT label reading: 5/160/12.5 identifies three ingredients in one tablet" }, "summary": { "zh": "本模块用当前美国公开标签帮助核对 EXFORGE HCT、氨氯地平、缬沙坦、氢氯噻嗪、完整三数字、口服薄膜衣片与 NDC。它不决定个人是否需要三种降压成分、每天用几片、能否与其他降压或利尿产品同用，或怎样调整。", "en": "This module uses the current U.S. public label to check EXFORGE HCT, amlodipine, valsartan, hydrochlorothiazide, the complete three-number marking, oral film-coated tablet and NDC. It does not decide whether someone needs all three ingredients, a tablet count, co-use with another antihypertensive/diuretic or an adjustment." }, "checks": [ { "zh": "5/160/12.5、10/160/12.5、5/160/25、10/160/25、10/320/25 mg 都是每片中三种成分的完整标示。不能只看一个数字，也不能从数字推导个人每天几片、加减量，或把单方和复方自行拼成同一产品。", "en": "5/160/12.5, 10/160/12.5, 5/160/25, 10/160/25 and 10/320/25 mg are complete three-ingredient markings per tablet. Do not read only one number, derive a personal tablet count, adjust an amount or self-assemble the product from single-ingredient and combination medicines." }, { "zh": "EXFORGE 只含氨氯地平和缬沙坦；EXFORGE HCT 还含氢氯噻嗪。名称相近、都含氨氯地平或缬沙坦，不能证明可自行叠加、轮换或替代。", "en": "EXFORGE contains amlodipine and valsartan only; EXFORGE HCT also contains hydrochlorothiazide. Similar names or a shared amlodipine/valsartan ingredient do not establish self-combination, alternation or substitution." }, { "zh": "正在使用其他降压药、利尿剂、含缬沙坦/氯沙坦/厄贝沙坦等产品、止痛药、盐替代品、补充剂或多种药物时，应把实际药盒和完整药单交给药师或医生核对。网页不能把“同类”或“共同成分”变成可否合用的个人结论。", "en": "With another antihypertensive, diuretic, a product containing valsartan/losartan/irbesartan, pain medicine, salt substitute, supplement or multiple medicines, have the actual packs and complete list reviewed by a pharmacist or clinician. A webpage cannot turn a shared class or ingredient into an individual co-use conclusion." }, { "zh": "怀孕/计划妊娠、晕厥、明显头晕、胸痛、呼吸困难、面部或咽喉肿胀等情况需要及时联系当地医生或紧急医疗支持；本页不决定是否自行停用、恢复或改用另一种药。", "en": "Pregnancy/planning pregnancy, fainting, marked dizziness, chest pain, breathing trouble, facial or throat swelling or another acute concern needs timely local clinical or urgent support; this page does not decide self-stopping, restarting or changing to another medicine." } ], "source": { "id": "src_dce8d9494db78945", "label": "DailyMed（NLM）：EXFORGE HCT 氨氯地平/缬沙坦/氢氯噻嗪当前美国公开标签（Novartis；SPL v33）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=18d7820d-471f-4ee2-9ec6-25d8d27c77de&version=33", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "三种成分怎样一起出现：钙通道、血管紧张素 II 受体与噻嗪类利尿路径", "en": "How three ingredients appear together: calcium-channel, angiotensin-II receptor and thiazide-diuretic pathways" }, "summary": { "zh": "当前标签将 EXFORGE HCT 描述为二氢吡啶类钙通道阻滞剂氨氯地平、血管紧张素 II 受体阻滞剂缬沙坦与噻嗪类利尿剂氢氯噻嗪的固定复方。机制帮助理解为什么完整药单核对重要，不预测个人血压、肾功能、电解质、疗效、用量或是否适合换药。", "en": "The current label describes EXFORGE HCT as a fixed combination of the dihydropyridine calcium-channel blocker amlodipine, the angiotensin-II receptor blocker valsartan and the thiazide diuretic hydrochlorothiazide. Mechanism helps explain why complete-list review matters; it does not predict an individual's blood pressure, kidney function, electrolytes, response, amount or whether a switch is suitable." }, "checks": [ { "zh": "三条作用路径不表示可以自行把其他钙通道阻滞剂、ARB、ACE 抑制剂、利尿剂或复方降压药再加一层。任何新增、停用、轮换或替代都要由掌握完整药单和病史的专业人员核对。", "en": "Three pathways do not mean another calcium-channel blocker, ARB, ACE inhibitor, diuretic or combination antihypertensive can be self-added. Any addition, stopping, alternation or substitution needs review by a professional with the complete list and history." }, { "zh": "标签中涉及血容量、肾功能、血钾/血钠或尿酸等词是需要专业复核的线索，不是从家庭血压读数、症状或网络经验自行调整片数的依据。", "en": "Label terms involving volume status, kidney function, potassium/sodium or uric acid are cues for professional review, not grounds to change tablet count from a home blood-pressure reading, symptoms or online experience." }, { "zh": "机制说明不能处理脱水、严重低血压样不适、胸痛、过敏、妊娠相关风险或复杂多药联用。出现急性或严重担忧时应优先使用当地医疗支持。", "en": "A mechanism explanation cannot manage dehydration, severe low-blood-pressure-like symptoms, chest pain, allergy, pregnancy-related risk or complex polypharmacy. With an acute or serious concern, prioritise local medical support." } ], "source": { "id": "src_dce8d9494db78945", "label": "DailyMed（NLM）：EXFORGE HCT 氨氯地平/缬沙坦/氢氯噻嗪当前美国公开标签（Clinical Pharmacology；SPL v33）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=18d7820d-471f-4ee2-9ec6-25d8d27c77de&version=33", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "Exforge HCT", "generic": "氨氯地平/缬沙坦/氢氯噻嗪", "dosageFormClass": "口服薄膜衣片：氨氯地平/缬沙坦/氢氯噻嗪 5/160/12.5、10/160/12.5、5/160/25、10/160/25、10/320/25 mg（当前美国标签所列）" }, "labelSource": { "id": "src_dce8d9494db78945", "label": "DailyMed（NLM）：EXFORGE HCT 氨氯地平/缬沙坦/氢氯噻嗪当前美国公开标签（Novartis；SPL v33）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=18d7820d-471f-4ee2-9ec6-25d8d27c77de&version=33", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "productRoutes": [ { "source": { "id": "src_dce8d9494db78945", "label": "DailyMed（NLM）：EXFORGE HCT 氨氯地平/缬沙坦/氢氯噻嗪当前美国公开标签（Novartis；SPL v33）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=18d7820d-471f-4ee2-9ec6-25d8d27c77de&version=33", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "DailyMed 当前 EXFORGE HCT 标签将其列为氨氯地平、缬沙坦和氢氯噻嗪的固定剂量三成分口服片，列有五种完整三数字标示。本页帮助核对品牌、全部三种成分、完整三数字、实际包装、标签版本和目标市场；不从任一数字生成个人片数、加减量、联用、换药或停药方案。", "history": "当前美国标签列示 Initial U.S. Approval: 2009，SPL v33 的 Updated 日期为 2025-12-12、DailyMed Published 日期为 2025-12-15。EXFORGE 仅含氨氯地平与缬沙坦；EXFORGE HCT 多出氢氯噻嗪。品牌名相近或共享成分都不建立自行替代、叠加或轮换关系。", "sourceDocuments": [ { "id": "src_dce8d9494db78945", "label": "DailyMed（NLM）：EXFORGE HCT 氨氯地平/缬沙坦/氢氯噻嗪当前美国公开标签（Novartis；SPL v33）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=18d7820d-471f-4ee2-9ec6-25d8d27c77de&version=33", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } ], "applicationNumber": "NDA 022314", "approvalTimeline": [ { "date": "2009-04-30", "title": { "zh": "NDA 022314 原始申请批准", "en": "NDA 022314 original application approval" }, "detail": { "zh": "FDA Drugs@FDA 公开记录将 EXFORGE HCT 的原始申请（ORIG 1）标为 2009-04-30 获批；该美国监管节点不建立其他市场的批准、供应或个人适用性。", "en": "The FDA Drugs@FDA public record lists EXFORGE HCT original application (ORIG 1) as approved on 30 Apr 2009. This U.S. regulatory node does not establish approval, supply or individual suitability in another market." }, "source": { "id": "src_bb60774a7963f6b6", "label": "FDA: EXFORGE HCT NDA 022314 original approval letter (2009-04-30)", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022314s000ltr.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "approval_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, { "date": "2009", "title": { "zh": "当前标签所列美国初始批准年份", "en": "Initial U.S. approval year listed in the current label" }, "detail": { "zh": "当前 EXFORGE HCT 标签列示 Initial U.S. Approval: 2009；该年份不自动说明其他市场的产品状态。", "en": "The current EXFORGE HCT label lists Initial U.S. Approval: 2009; it does not establish product status in another market." }, "source": { "id": "src_dce8d9494db78945", "label": "DailyMed: current EXFORGE HCT public label, SPL v33", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=18d7820d-471f-4ee2-9ec6-25d8d27c77de&version=33", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, { "date": "2025-12-12", "title": { "zh": "当前 SPL v33 更新日期", "en": "Current SPL v33 updated date" }, "detail": { "zh": "DailyMed 当前标签的 Updated 日期为 2025-12-12；该日期与公开日期分开记录。", "en": "The current DailyMed label's updated date is 12 Dec 2025; it remains separate from publication." }, "source": { "id": "src_dce8d9494db78945", "label": "DailyMed: current EXFORGE HCT public label, SPL v33", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=18d7820d-471f-4ee2-9ec6-25d8d27c77de&version=33", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, { "date": "2025-12-15", "title": { "zh": "DailyMed 公开当前 SPL v33", "en": "DailyMed published current SPL v33" }, "detail": { "zh": "DailyMed 将当前 v33 的 Published Date 列为 2025-12-15；页面不把它解释成个人治疗建议。", "en": "DailyMed lists 15 Dec 2025 as the current v33 Published Date; this page does not interpret it as individual-treatment advice." }, "source": { "id": "src_dce8d9494db78945", "label": "DailyMed: current EXFORGE HCT public label, SPL v33", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=18d7820d-471f-4ee2-9ec6-25d8d27c77de&version=33", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "已链接当前三成分标签与一个精确包装展示", "en": "Current three-ingredient label and one exact package panel linked" }, "detail": { "zh": "展示图只对应 5 mg/160 mg/12.5 mg、NDC 0078-0559-15、30 片装；不据此建立实际在售、库存或其他规格状态。", "en": "The image corresponds only to the 5 mg/160 mg/12.5 mg, NDC 0078-0559-15, 30-tablet panel; it does not establish actual marketing, stock or another-strength status." } }, { "market": { "zh": "中国大陆、欧盟、日本及其他市场", "en": "Mainland China, EU, Japan and other markets" }, "status": { "zh": "待逐项建立市场记录", "en": "Market record not established" }, "detail": { "zh": "不从美国标签推定当地商品名、批准、规格、供应、原研关系或可替代性。", "en": "No local trade name, approval, strength, supply, originator relationship or interchangeability is inferred from the U.S. label." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "5/160/12.5 mg 是不是只看其中一个数字即可？", "en": "Can 5/160/12.5 mg be read as just one of its three numbers?" }, "answer": { "zh": "不能。它表示这一准确复方片中氨氯地平、缬沙坦和氢氯噻嗪的三组标示量。页面不把它变成个人片数、调整或与单方药的换算。", "en": "No. It identifies the three labelled ingredient amounts in this exact fixed-combination tablet. The page does not turn it into an individual tablet count, adjustment or conversion to single-ingredient medicines." } }, { "question": { "zh": "EXFORGE 与 EXFORGE HCT 能否自行互换？", "en": "Can EXFORGE and EXFORGE HCT be self-switched?" }, "answer": { "zh": "不能。EXFORGE HCT 另含氢氯噻嗪，是三成分产品。相近品牌名不建立可自行互换关系；请带实际药盒和完整药单咨询药师或开方团队。", "en": "No. EXFORGE HCT additionally contains hydrochlorothiazide and is a three-ingredient product. Similar brand names do not establish self-interchangeability; take the actual packs and complete medicine list to a pharmacist or prescribing team." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "dosage-forms-are-part-of-medicine-identity", "how-to-read-a-drug-label" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/exforge-hct/", "en": "https://origindrug.com/en/drugs/exforge-hct/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "avapro", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-30", "status": "published_traceable_archive" }, "names": { "brand": "Avapro", "generic": "厄贝沙坦", "aliases": [ "irbesartan", "厄贝沙坦", "厄贝沙坦片", "安博维", "安博维®" ], "marketBrandNames": [ { "name": "安博维®", "market": { "zh": "中国大陆（赛诺菲中国当前产品页）", "en": "Mainland China (current Sanofi China product page)" }, "evidenceStatus": "publication_status_unresolved", "note": { "zh": "赛诺菲中国当前产品页将安博维®对应为厄贝沙坦片，并列出进口/地产 0.15 g 片剂。这里仅建立中国药盒名称和 0.15 g 规格入口；美国 AVAPRO 档案展示 150 mg 与 300 mg 两种片剂，当前中国产品页本身不为本页建立中国 0.3 g 包装、库存或可购买结论。", "en": "The current Sanofi China product page maps Aprovel® (安博维®) to irbesartan tablets and lists imported and locally produced 0.15 g tablets. This creates only a China pack-name and 0.15 g strength route. The U.S. AVAPRO dossier displays 150 mg and 300 mg tablets; the current China product page itself does not establish a Chinese 0.3 g package, stock or purchase availability here." }, "source": { "id": "src_53827851969aef35", "label": "赛诺菲中国：安博维® 厄贝沙坦片当前产品页（0.15 g）", "url": "https://www.sanofi.cn/zh/your-health/products/aprovel", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "first_party_product_page", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" } } ], "mainlandChinaTradeNameCue": { "value": "安博维®", "status": "discovery_cue_requires_target_market_verification", "source": { "id": "src_53827851969aef35", "label": "赛诺菲中国：安博维® 厄贝沙坦片当前产品页（0.15 g）", "url": "https://www.sanofi.cn/zh/your-health/products/aprovel", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "first_party_product_page", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" } } }, "identity": { "therapeuticArea": "心血管", "sourceArchiveMarket": "美国 DailyMed 有日期公开标签（页面 2026-02-19 更新；本档案分别展示两个准确包装面板）。中国大陆“安博维®”只作为赛诺菲中国当前产品页约束的 0.15 g 厄贝沙坦片名称线索，不推定其他中国规格、供应、购买资格或跨市场可替代性。", "dosageFormClass": "厄贝沙坦口服薄膜衣片：美国档案展示 150 mg、300 mg 两个 30 片瓶装面板；赛诺菲中国当前产品页列示安博维® 0.15 g 片剂，两个市场须分别核对。", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "1997（DailyMed 美国公开标签所列初始批准）", "archiveSponsorText": "Sanofi-Aventis U.S. LLC / DailyMed（NLM）公开标签档案；中国大陆名称线索来自赛诺菲中国当前产品页" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [ "AVALIDE", "irbesartan hydrochlorothiazide", "厄贝沙坦氢氯噻嗪" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-avapro-irbesartan-tablet-150mg-0024585130", "marketCode": "US", "labelVersion": { "zh": "DailyMed 页面 2026-02-19 更新；SPL v20 于 2026-03-03 发布", "en": "DailyMed page updated 19 Feb 2026; SPL v20 published 3 Mar 2026" }, "dosageForm": { "zh": "AVAPRO 厄贝沙坦口服薄膜衣片", "en": "AVAPRO irbesartan oral film-coated tablet" }, "route": { "zh": "口服（仅作标签产品身份字段）", "en": "oral (label product-identity field only)" }, "routeCodes": [ "oral" ], "productCode": "NDC 0024-5851-30", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片 150 mg；30 片瓶装", "en": "150 mg per tablet; 30-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=7885b2a8-be4e-48ab-8113-4e6ab791eb98&name=7885b2a8-be4e-48ab-8113-4e6ab791eb98-05.jpg", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "厄贝沙坦", "en": "irbesartan" }, "value": 150, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人服用片数、加减、补服、换药或换算指令", "en": "labelled amount per tablet; not an individual tablet count, adjustment, make-up, switching or conversion instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "塑料瓶", "en": "plastic bottle" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-21", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 30, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "白色至类白色", "en": "white to off-white" }, "shape": { "zh": "双凸椭圆形", "en": "biconvex oval" }, "imprint": "heart / 2872", "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_c78599f7313a7d3b", "label": "DailyMed（NLM）：AVAPRO 厄贝沙坦 150 mg、30 片瓶装美国公开标签面板（Sanofi；2026-02-19 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=7885b2a8-be4e-48ab-8113-4e6ab791eb98", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-avapro-irbesartan-tablet-300mg-0024585230", "marketCode": "US", "labelVersion": { "zh": "DailyMed 页面 2026-02-19 更新；SPL v20 于 2026-03-03 发布", "en": "DailyMed page updated 19 Feb 2026; SPL v20 published 3 Mar 2026" }, "dosageForm": { "zh": "AVAPRO 厄贝沙坦口服薄膜衣片", "en": "AVAPRO irbesartan oral film-coated tablet" }, "route": { "zh": "口服（仅作标签产品身份字段）", "en": "oral (label product-identity field only)" }, "routeCodes": [ "oral" ], "productCode": "NDC 0024-5852-30", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片 300 mg；30 片瓶装", "en": "300 mg per tablet; 30-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=7885b2a8-be4e-48ab-8113-4e6ab791eb98&name=7885b2a8-be4e-48ab-8113-4e6ab791eb98-06.jpg", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "厄贝沙坦", "en": "irbesartan" }, "value": 300, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人服用片数、加减、补服、换药或换算指令", "en": "labelled amount per tablet; not an individual tablet count, adjustment, make-up, switching or conversion instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "塑料瓶", "en": "plastic bottle" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-21", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 30, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "白色至类白色", "en": "white to off-white" }, "shape": { "zh": "双凸椭圆形", "en": "biconvex oval" }, "imprint": "heart / 2873", "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_c78599f7313a7d3b", "label": "DailyMed（NLM）：AVAPRO 厄贝沙坦 300 mg、30 片瓶装美国公开标签面板（Sanofi；2026-02-19 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=7885b2a8-be4e-48ab-8113-4e6ab791eb98", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-avapro-irbesartan-tablet-150mg-0024585130", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=7885b2a8-be4e-48ab-8113-4e6ab791eb98-05.jpg&setid=7885b2a8-be4e-48ab-8113-4e6ab791eb98&type=img", "alt": "AVAPRO 厄贝沙坦在美国 DailyMed Sanofi-Aventis 公开标签中的 150 mg、30 片装包装面板", "archiveMarket": "美国", "labelVersion": "DailyMed 页面 2026-02-19 更新；SPL v20 于 2026-03-03 发布", "presentation": "AVAPRO 厄贝沙坦薄膜衣片：每片 150 mg、30 片装包装面板（NDC 0024-5851-30；DailyMed 页面 2026-02-19 更新标签所列）。", "notice": "此为美国 DailyMed Sanofi-Aventis 公开标签中明确对应 AVAPRO、厄贝沙坦 150 mg、30 片装的包装面板，只帮助核对品牌、通用名、每片标示量、薄膜衣片、包装数量和来源；不用于鉴定真伪，也不证明 300 mg、其他包装、其他市场标签、当前可得性、原研身份、目标市场批准或可售资格。", "source": { "id": "src_c78599f7313a7d3b", "label": "DailyMed（NLM）：AVAPRO 厄贝沙坦公开标签（Sanofi-Aventis U.S. LLC，2026-02-19 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=7885b2a8-be4e-48ab-8113-4e6ab791eb98", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "AVAPRO 说明书放大阅读：150 mg、300 mg 先用于确认准确片剂", "en": "AVAPRO label reading: 150 mg and 300 mg first identify the exact tablet" }, "summary": { "zh": "本模块以美国 DailyMed 公开标签和包装图为阅读入口，帮助核对 AVAPRO、厄贝沙坦、150 mg/300 mg 薄膜衣片及目标市场。它不提供任何人的片数、开始/停止、联用、转换或血压处理方案。", "en": "This module uses the U.S. DailyMed public label and package image to check AVAPRO, irbesartan, 150 mg/300 mg film-coated tablets and the target market. It does not provide an individual's tablet count, start/stop, combination, switching or blood-pressure-management plan." }, "checks": [ { "zh": "150 mg、300 mg 是美国标签所列每片标示强度，不是网页给任何人计算今天应服几片的答案。先同时核对 AVAPRO、厄贝沙坦、每片强度、薄膜衣片、实际包装和目标市场。", "en": "150 mg and 300 mg are labelled strengths per tablet in the U.S. label, not a web answer to how many tablets anyone should take today. Check AVAPRO, irbesartan, strength per tablet, film-coated tablet, actual pack and target market together." }, { "zh": "标签将 150 mg 与 300 mg 描述为不同片剂；包装数字、片剂外观或同为“降压药”都不授权自行加减、掰开、轮换、补用或以另一种产品替代。任何这类问题要回到准确产品的现行标签、处方和药师/医生复核。", "en": "The label describes 150 mg and 300 mg as distinct tablets. Package numbers, tablet appearance or a shared ‘blood-pressure medicine’ description do not authorise self-adjusting, splitting, alternating, catch-up use or replacing with another product. Such questions must return to the current label, prescription and pharmacist/clinician review for the exact product." }, { "zh": "该标签列有与其他降压药、利尿剂、含钾补充剂或代盐、NSAIDs、锂盐等相关的核对事项。正在使用心血管、肾脏、止痛、感冒或补充剂产品时，应把所有实际药盒和完整药单交由专业人员一起核对，不要因药名不同就推定可以安全合用。", "en": "The label contains checks involving other blood-pressure medicines, diuretics, potassium supplements or salt substitutes, NSAIDs and lithium. With cardiovascular, kidney, pain, cold or supplement products, have a professional review the actual packs and complete medicine list together; different names do not establish that co-use is safe." }, { "zh": "标签含妊娠、低血压和肾功能相关警示。出现晕厥、明显虚弱、严重不适，或处于妊娠/备孕、脱水、肾脏问题等情形时，应及时使用当地医疗与开方团队渠道；网页不判断是否自行继续、停用或换药。", "en": "The label includes pregnancy, low-blood-pressure and kidney-function warnings. With fainting, marked weakness, a serious concern, or pregnancy/planning pregnancy, dehydration or kidney concerns, use local medical and prescribing-team pathways promptly; this page does not decide whether to self-continue, stop or switch." } ], "source": { "id": "src_c78599f7313a7d3b", "label": "DailyMed（NLM）：AVAPRO 厄贝沙坦公开标签（Sanofi-Aventis U.S. LLC，2026-02-19 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=7885b2a8-be4e-48ab-8113-4e6ab791eb98", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "厄贝沙坦怎样起作用：标签将其归为血管紧张素 II 受体阻断剂", "en": "How irbesartan works: the label classifies it as an angiotensin II receptor blocker" }, "summary": { "zh": "DailyMed 标签将 AVAPRO 描述为血管紧张素 II 受体（AT1 亚型）拮抗剂。它帮助解释药物类别与标签中的相互作用、妊娠和肾功能警示；不能由此判断个人血压原因、适用性、片数、联用或转换方案。", "en": "The DailyMed label describes AVAPRO as an angiotensin II receptor (AT1 subtype) antagonist. This helps explain the drug class and the label's interaction, pregnancy and kidney-function warnings; it cannot determine an individual's blood-pressure cause, suitability, tablet count, combination or switching plan." }, "checks": [ { "zh": "可以把 AT1 受体理解为血管紧张素 II 作用路径中的一个“接点”。这解释的是药理类别，不是对个人血压读数、症状、心肾状况或是否需要治疗的判断。", "en": "An AT1 receptor can be read as one ‘connection point’ in the angiotensin II pathway. This explains a pharmacologic class, not a judgement about an individual's blood-pressure reading, symptoms, heart/kidney status or need for treatment." }, { "zh": "共享“ARB”类别或都写有“降压”用途，不支持把 AVAPRO 与其他 ARB、ACE 抑制剂、利尿剂或任何心血管药自行叠加、轮换或互换。产品、剂型、既往反应、肾功能、血压记录和完整药单必须由专业人员一起核对。", "en": "A shared ARB class or blood-pressure wording does not support self-combining, alternating or substituting AVAPRO with another ARB, an ACE inhibitor, a diuretic or any cardiovascular medicine. Product, dosage form, prior reactions, kidney function, blood-pressure records and the complete medicine list require professional review together." }, { "zh": "机制页面也不能把“受体阻断”转换成对孕期、肾功能变化、脱水、头晕或新不适的个人处理建议。出现急性或严重不适时，应优先使用当地紧急医疗支持，而不是依据本页自行调整。", "en": "A mechanism page also cannot turn ‘receptor blockade’ into personal advice for pregnancy, kidney-function changes, dehydration, dizziness or a new concern. With an acute or serious issue, prioritise local urgent medical support rather than self-adjusting from this page." } ], "source": { "id": "src_c78599f7313a7d3b", "label": "DailyMed（NLM）：AVAPRO 厄贝沙坦公开标签（Clinical Pharmacology，2026-02-19 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=7885b2a8-be4e-48ab-8113-4e6ab791eb98", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "Avapro", "generic": "厄贝沙坦", "dosageFormClass": "厄贝沙坦口服薄膜衣片：美国档案展示 150 mg、300 mg 两个 30 片瓶装面板；赛诺菲中国当前产品页列示安博维® 0.15 g 片剂，两个市场须分别核对。" }, "labelSource": { "id": "src_c78599f7313a7d3b", "label": "DailyMed（NLM）：AVAPRO 厄贝沙坦公开标签（Sanofi-Aventis U.S. LLC，2026-02-19 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=7885b2a8-be4e-48ab-8113-4e6ab791eb98", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "productRoutes": [ { "source": { "id": "src_c78599f7313a7d3b", "label": "DailyMed（NLM）：AVAPRO 厄贝沙坦公开标签（Sanofi-Aventis U.S. LLC，2026-02-19 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=7885b2a8-be4e-48ab-8113-4e6ab791eb98", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_a87cf21ea79fb712", "label": "FDA：AVAPRO 2025 美国处方信息（NDA 020757）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/020757s080lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "美国 DailyMed 的 AVAPRO（irbesartan）有日期公开标签列有 150 mg、300 mg 口服薄膜衣片；本页分别建立两个准确包装面板的品牌、通用名、每片强度、NDC、外观线索和来源核对卡。它不把包装数字变成个人片数、加减、补服、停用、换药或联用方案，也不据此推定原研关系、目标市场批准、供应或销售资格。", "history": "DailyMed 页面列示 AVAPRO 的 Initial U.S. Approval: 1997，且当前公开标签列示 Sanofi-Aventis U.S. LLC 为包装商。本页的两个包装面板只对应 DailyMed 页面 2026-02-19 更新时所列的 AVAPRO 单方厄贝沙坦 150 mg、300 mg、30 片瓶装；AVALIDE 等厄贝沙坦/氢氯噻嗪复方产品不能按品牌或成分重叠并入本单方片剂档案。", "sourceDocuments": [ { "id": "src_c78599f7313a7d3b", "label": "DailyMed（NLM）：AVAPRO 厄贝沙坦公开标签（Sanofi-Aventis U.S. LLC，2026-02-19 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=7885b2a8-be4e-48ab-8113-4e6ab791eb98", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_a87cf21ea79fb712", "label": "FDA：AVAPRO 2025 美国处方信息（NDA 020757）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/020757s080lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } ], "applicationNumber": "NDA 020757", "approvalTimeline": [ { "date": "1997", "title": { "zh": "FDA 标签所列美国初始批准年份", "en": "Initial U.S. approval year listed in the FDA label" }, "detail": { "zh": "本页链接的 FDA 标签档案列示 Initial U.S. Approval: 1997。该历史定位不等同于当前批准、可得性、持有人或其他市场状态。", "en": "The FDA label archive linked here lists Initial U.S. Approval: 1997. This historical locator is not a conclusion about current approval, availability, holder or another market." }, "source": { "id": "src_a642af57878f425b", "label": "DailyMed: AVAPRO public label archive", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=7885b2a8-be4e-48ab-8113-4e6ab791eb98", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, { "date": "2026-03", "title": { "zh": "FDA 标签档案版本", "en": "FDA label archive version" }, "detail": { "zh": "本页链接 2026-03 的 FDA 标签档案作为可复核阅读入口。现行标签、规格、适应症和安全信息必须另行以目标市场当前文件核对。", "en": "This page links the 2026-03 FDA label archive as a traceable reading entry point. Current labeling, strength, indication and safety information require separate verification against the target market’s current document." }, "source": { "id": "src_a642af57878f425b", "label": "DailyMed: AVAPRO public label archive", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=7885b2a8-be4e-48ab-8113-4e6ab791eb98", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "已链接公开标签档案", "en": "Public label archive linked" }, "detail": { "zh": "仅对应本页所列 FDA 文件。", "en": "Only the FDA document listed on this page is linked." } }, { "market": { "zh": "中国大陆、欧盟、日本", "en": "Mainland China, EU, Japan" }, "status": { "zh": "待逐项建立市场记录", "en": "Market record not established" }, "detail": { "zh": "不从美国标签档案推定当地批准、持有人、规格、供应或可售资格。", "en": "No local approval, holder, strength, supply or sale-eligibility conclusion is inferred from the U.S. label archive." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "标签档案能代表现在的产品信息吗？", "en": "Does a label archive represent current product information?" }, "answer": { "zh": "不能自动代表。档案用于定位来源；需要以目标市场的现行官方标签逐项复核。", "en": "Not automatically. The archive locates a source; each point needs verification against the target market’s current official label." } }, { "question": { "zh": "为什么这里不展示价格或原研/仿制结论？", "en": "Why are price and originator/generic conclusions not shown?" }, "answer": { "zh": "这些结论需要产品、剂型、规格、包装、市场、日期和原始记录分别齐全并经人工审核；单一标签文件不足以支持。", "en": "Those conclusions require separately complete and human-reviewed product, dosage-form, strength, pack, market, date and primary-record fields; one label file is insufficient." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "how-to-read-a-drug-label", "regulatory-sources-first" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/avapro/", "en": "https://origindrug.com/en/drugs/avapro/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "micardis", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-28", "status": "published_traceable_archive" }, "names": { "brand": "Micardis", "generic": "替米沙坦", "aliases": [ "telmisartan", "替米沙坦", "替米沙坦片", "美卡素" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": { "value": "美卡素®", "status": "discovery_cue_requires_target_market_verification", "source": { "id": "src_daf163775527c72b", "label": "江阴市人民政府：2024 年常用药品信息中的美卡素／替米沙坦片 80 mg 记录", "url": "https://www.jiangyin.gov.cn/doc/2024/03/26/1217423.shtml", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "government_medicine_listing", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-12", "reviewedAt": "2026-09-12" } } }, "identity": { "therapeuticArea": "心血管", "sourceArchiveMarket": "美国公开处方药标签档案（DailyMed 2025-05 版本）", "dosageFormClass": "口服片剂：20 mg、40 mg、80 mg（本档案所列）", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "1998（DailyMed 美国公开标签所列初始批准）", "archiveSponsorText": "Boehringer Ingelheim Pharmaceuticals, Inc. / DailyMed（NLM）公开标签档案" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-micardis-20mg-ndc-0597-0039-37", "marketCode": "US", "labelVersion": { "zh": "DailyMed 2025-05；标签文字规格，不代表当前供应", "en": "DailyMed May 2025; labelled package text, not current availability" }, "dosageForm": { "zh": "口服片剂", "en": "oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 0597-0039-37", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "20 mg／片；30 片（3 × 10 泡罩卡）", "en": "20 mg per tablet; 30 tablets (3 × 10 blister cards)" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=micardis-05.jpg&archiveid=890860", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "替米沙坦", "en": "telmisartan" }, "value": 20, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标示量", "en": "per labelled tablet" } } ], "concentration": null, "container": { "typeCode": "carton_with_blister_cards", "typeLabel": { "zh": "含 3 张泡罩卡的纸盒", "en": "carton with 3 blister cards" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "片", "en": "tablets" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": null, "package": { "count": 30, "unit": { "zh": "片／盒（3 × 10 泡罩卡）", "en": "tablets per carton (3 × 10 blister cards)" } }, "physicalClues": { "color": { "zh": "白色或类白色", "en": "white or off-white" }, "shape": { "zh": "圆形、无包衣", "en": "round, uncoated" }, "imprint": { "zh": "BI 标志 / 50H", "en": "BI logo / 50H" }, "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_e51f7c3a24832b66", "label": "DailyMed（NLM）：MICARDIS 替米沙坦公开标签（Boehringer Ingelheim，2025-05 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=cfb9309f-e0df-4a55-9542-0e869fce05fb", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-micardis-40mg-ndc-0597-0040-37", "marketCode": "US", "labelVersion": { "zh": "DailyMed 2025-05；标签文字规格，不代表当前供应", "en": "DailyMed May 2025; labelled package text, not current availability" }, "dosageForm": { "zh": "口服片剂", "en": "oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 0597-0040-37", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "40 mg／片；30 片（3 × 10 泡罩卡）", "en": "40 mg per tablet; 30 tablets (3 × 10 blister cards)" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=micardis-06.jpg&archiveid=890860", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "替米沙坦", "en": "telmisartan" }, "value": 40, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标示量", "en": "per labelled tablet" } } ], "concentration": null, "container": { "typeCode": "carton_with_blister_cards", "typeLabel": { "zh": "含 3 张泡罩卡的纸盒", "en": "carton with 3 blister cards" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "片", "en": "tablets" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": null, "package": { "count": 30, "unit": { "zh": "片／盒（3 × 10 泡罩卡）", "en": "tablets per carton (3 × 10 blister cards)" } }, "physicalClues": { "color": { "zh": "白色或类白色", "en": "white or off-white" }, "shape": { "zh": "椭圆形、无包衣", "en": "oblong, uncoated" }, "imprint": { "zh": "BI 标志 / 51H", "en": "BI logo / 51H" }, "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_e51f7c3a24832b66", "label": "DailyMed（NLM）：MICARDIS 替米沙坦公开标签（Boehringer Ingelheim，2025-05 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=cfb9309f-e0df-4a55-9542-0e869fce05fb", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-micardis-80mg-ndc-0597-0041-37", "marketCode": "US", "labelVersion": { "zh": "DailyMed 2025-05；标签文字规格，不代表当前供应", "en": "DailyMed May 2025; labelled package text, not current availability" }, "dosageForm": { "zh": "口服片剂", "en": "oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 0597-0041-37", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "80 mg／片；30 片（3 × 10 泡罩卡）", "en": "80 mg per tablet; 30 tablets (3 × 10 blister cards)" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=micardis-07.jpg&archiveid=890860", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "替米沙坦", "en": "telmisartan" }, "value": 80, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标示量", "en": "per labelled tablet" } } ], "concentration": null, "container": { "typeCode": "carton_with_blister_cards", "typeLabel": { "zh": "含 3 张泡罩卡的纸盒", "en": "carton with 3 blister cards" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "片", "en": "tablets" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": null, "package": { "count": 30, "unit": { "zh": "片／盒（3 × 10 泡罩卡）", "en": "tablets per carton (3 × 10 blister cards)" } }, "physicalClues": { "color": { "zh": "白色或类白色", "en": "white or off-white" }, "shape": { "zh": "椭圆形、无包衣", "en": "oblong, uncoated" }, "imprint": { "zh": "BI 标志 / 52H", "en": "BI logo / 52H" }, "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_e51f7c3a24832b66", "label": "DailyMed（NLM）：MICARDIS 替米沙坦公开标签（Boehringer Ingelheim，2025-05 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=cfb9309f-e0df-4a55-9542-0e869fce05fb", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-micardis-20mg-ndc-0597-0039-37", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=micardis-05.jpg&archiveid=890860", "alt": "MICARDIS 20 mg、30 片（3 × 10 泡罩卡）、NDC 0597-0039-37 在美国 DailyMed 公开标签中的纸盒展示面", "archiveMarket": "美国", "labelVersion": "DailyMed 2025-05 公开标签；纸盒图稿标示 2022", "presentation": "MICARDIS（telmisartan）20 mg：30 片（3 × 10 泡罩卡），NDC 0597-0039-37", "notice": "此图只对应美国 DailyMed 公开标签中 MICARDIS 20 mg、30 片（3 × 10 泡罩卡）、NDC 0597-0039-37 的纸盒展示面。它帮助核对品牌、通用名、每片强度、包装与来源；不用于鉴定真伪，也不证明 40 mg、80 mg、其他市场、当前供应、目标市场批准、原研身份或个人用药方案。", "source": { "id": "src_e51f7c3a24832b66", "label": "DailyMed（NLM）：MICARDIS 替米沙坦 20 mg、30 片（3 × 10 泡罩卡）美国公开标签纸盒面板（Boehringer Ingelheim，2025-05 标签）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=cfb9309f-e0df-4a55-9542-0e869fce05fb", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "MICARDIS 说明书放大阅读：20、40、80 mg 先用于确认准确片剂", "en": "MICARDIS label reading: 20, 40 and 80 mg first identify the exact tablet" }, "summary": { "zh": "本模块以美国 DailyMed 公开标签为阅读入口，帮助核对 MICARDIS、替米沙坦、每片标示量、口服片剂和目标市场。它不提供任何人的片数、开始/停用、联用、转换或血压处理方案。", "en": "This module uses the U.S. DailyMed public label to check MICARDIS, telmisartan, stated amount per tablet, oral tablets and the target market. It does not provide an individual's tablet count, start/stop, combination, switching or blood-pressure-management plan." }, "checks": [ { "zh": "20 mg、40 mg、80 mg 是美国标签所列每片标示强度，不是网页给任何人计算今天应服几片的答案。应同时核对 MICARDIS、替米沙坦、每片强度、口服片剂、实际包装和目标市场。", "en": "20 mg, 40 mg and 80 mg are labelled strengths per tablet in the U.S. label, not a web answer to how many tablets anyone should take today. Check MICARDIS, telmisartan, strength per tablet, oral tablet, actual pack and target market together." }, { "zh": "同为“降压药”、同属相关类别或包装数字相近，都不授权自行叠加、轮换、补用、掰开，或以另一种强度、剂型或产品替代。涉及任何变动时，应回到准确产品的现行标签、处方和药师/医生复核。", "en": "A shared blood-pressure description, related class or similar package number does not authorise self-combining, alternating, catch-up use, splitting or replacement with another strength, form or product. Any change must return to the current label, prescription and pharmacist/clinician review for the exact product." }, { "zh": "标签列有与其他血压药、利尿剂、含钾补充剂或代盐、NSAIDs、锂盐等有关的核对事项。正在使用心血管、肾脏、止痛、感冒或补充剂产品时，应把所有实际药盒与完整药单交由专业人员一起核对，不要因名称不同就推定可以安全合用。", "en": "The label contains checks involving other blood-pressure medicines, diuretics, potassium supplements or salt substitutes, NSAIDs and lithium. With cardiovascular, kidney, pain, cold or supplement products, have a professional review the actual packs and complete medicine list together; different names do not establish that co-use is safe." }, { "zh": "该标签含妊娠、低血压、肾功能和高钾相关警示。出现晕厥、明显虚弱、严重不适，或处于妊娠/备孕、脱水、肾脏问题等情形时，应及时使用当地医疗与开方团队渠道；网页不判断是否自行继续、停用或换药。", "en": "The label includes pregnancy, low-blood-pressure, kidney-function and high-potassium warnings. With fainting, marked weakness, a serious concern, or pregnancy/planning pregnancy, dehydration or kidney concerns, use local medical and prescribing-team pathways promptly; this page does not decide whether to self-continue, stop or switch." } ], "source": { "id": "src_e51f7c3a24832b66", "label": "DailyMed（NLM）：MICARDIS 替米沙坦公开标签（Boehringer Ingelheim，2025-05 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=cfb9309f-e0df-4a55-9542-0e869fce05fb", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "替米沙坦怎样起作用：标签将其归为血管紧张素 II 受体阻断剂", "en": "How telmisartan works: the label classifies it as an angiotensin II receptor blocker" }, "summary": { "zh": "DailyMed 标签将 MICARDIS 描述为血管紧张素 II 受体（AT1 亚型）拮抗剂。它帮助解释药物类别与标签中的相互作用、妊娠、肾功能和高钾警示；不能由此判断个人血压原因、适用性、片数、联用或转换方案。", "en": "The DailyMed label describes MICARDIS as an angiotensin II receptor (AT1 subtype) antagonist. This helps explain the drug class and the label's interaction, pregnancy, kidney-function and high-potassium warnings; it cannot determine an individual's blood-pressure cause, suitability, tablet count, combination or switching plan." }, "checks": [ { "zh": "可以把 AT1 受体理解为血管紧张素 II 作用路径中的一个“接点”。这解释的是药理类别，不是对个人血压读数、症状、心肾状况或是否需要治疗的判断。", "en": "An AT1 receptor can be read as one ‘connection point’ in the angiotensin II pathway. This explains a pharmacologic class, not a judgement about an individual's blood-pressure reading, symptoms, heart/kidney status or need for treatment." }, { "zh": "共享“ARB”类别或都写有“降压”用途，不支持把 MICARDIS 与其他 ARB、ACE 抑制剂、利尿剂或任何心血管药自行叠加、轮换或互换。产品、剂型、既往反应、肾功能、血压记录和完整药单必须由专业人员一起核对。", "en": "A shared ARB class or blood-pressure wording does not support self-combining, alternating or substituting MICARDIS with another ARB, an ACE inhibitor, a diuretic or any cardiovascular medicine. Product, dosage form, prior reactions, kidney function, blood-pressure records and the complete medicine list require professional review together." }, { "zh": "机制页面也不能把“受体阻断”转换成对孕期、肾功能变化、脱水、头晕或新不适的个人处理建议。出现急性或严重不适时，应优先使用当地紧急医疗支持，而不是依据本页自行调整。", "en": "A mechanism page also cannot turn ‘receptor blockade’ into personal advice for pregnancy, kidney-function changes, dehydration, dizziness or a new concern. With an acute or serious issue, prioritise local urgent medical support rather than self-adjusting from this page." } ], "source": { "id": "src_e51f7c3a24832b66", "label": "DailyMed（NLM）：MICARDIS 替米沙坦公开标签（Clinical Pharmacology，2025-05 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=cfb9309f-e0df-4a55-9542-0e869fce05fb", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "Micardis", "generic": "替米沙坦", "dosageFormClass": "口服片剂：20 mg、40 mg、80 mg（本档案所列）" }, "labelSource": { "id": "src_e51f7c3a24832b66", "label": "DailyMed（NLM）：MICARDIS 替米沙坦公开标签（Boehringer Ingelheim，2025-05 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=cfb9309f-e0df-4a55-9542-0e869fce05fb", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "productRoutes": [ { "source": { "id": "src_e51f7c3a24832b66", "label": "DailyMed（NLM）：MICARDIS 替米沙坦公开标签（Boehringer Ingelheim，2025-05 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=cfb9309f-e0df-4a55-9542-0e869fce05fb", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_bf8aec96a9049f72", "label": "FDA：MICARDIS 2012 美国处方信息（NDA 020850）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020850s033lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "DailyMed 的 MICARDIS（telmisartan）美国公开标签列示 20 mg、40 mg、80 mg 口服片剂，并列示美国初始批准年份为 1998。本页把三种强度各自对应的 30 片（3 × 10 泡罩卡）官方标签纸盒图、品牌、通用名、每片标示强度、剂型与原始标签并列，帮助核对准确产品；不据此生成个人片数、加减量、联用、转换、停药或血压处理方案。", "history": "本档案链接的 DailyMed 页面是美国公开标签阅读入口，页面所列包装商为 Boehringer Ingelheim Pharmaceuticals, Inc.。本页 20 mg、40 mg、80 mg 三张纸盒图分别对应同一公开标签中的准确 NDC 与 3 × 10 泡罩卡面板，仅用于核对这一美国标签产品，不作真伪鉴定，也不证明中国大陆或任何其他市场的当前批准、持有人、可获得性、价格、原研/仿制关系或可售资格；均须按目标市场的现行官方记录另行核验。", "sourceDocuments": [ { "id": "src_e51f7c3a24832b66", "label": "DailyMed（NLM）：MICARDIS 替米沙坦公开标签（Boehringer Ingelheim，2025-05 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=cfb9309f-e0df-4a55-9542-0e869fce05fb", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_bf8aec96a9049f72", "label": "FDA：MICARDIS 2012 美国处方信息（NDA 020850）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020850s033lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_5ed30b676fbb9773", "label": "FDA Drugs@FDA 官方检索入口", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_lookup_entry", "documentKind": "regulatory_lookup", "market": "US", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } ], "applicationNumber": "NDA 020850", "approvalTimeline": [ { "date": "1998", "title": { "zh": "FDA 标签所列美国初始批准年份", "en": "Initial U.S. approval year listed in the FDA label" }, "detail": { "zh": "本页链接的 FDA 标签档案列示 Initial U.S. Approval: 1998。该历史定位不等同于当前批准、可得性、持有人或其他市场状态。", "en": "The FDA label archive linked here lists Initial U.S. Approval: 1998. This historical locator is not a conclusion about current approval, availability, holder or another market." }, "source": { "id": "src_e51f7c3a24832b66", "label": "DailyMed: MICARDIS public label archive", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=cfb9309f-e0df-4a55-9542-0e869fce05fb", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, { "date": "2025-05", "title": { "zh": "FDA 标签档案版本", "en": "FDA label archive version" }, "detail": { "zh": "本页链接 2025-05 的 FDA 标签档案作为可复核阅读入口。现行标签、规格、适应症和安全信息必须另行以目标市场当前文件核对。", "en": "This page links the 2025-05 FDA label archive as a traceable reading entry point. Current labeling, strength, indication and safety information require separate verification against the target market’s current document." }, "source": { "id": "src_e51f7c3a24832b66", "label": "DailyMed: MICARDIS public label archive", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=cfb9309f-e0df-4a55-9542-0e869fce05fb", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "已链接公开标签档案", "en": "Public label archive linked" }, "detail": { "zh": "仅对应本页所列 FDA 文件。", "en": "Only the FDA document listed on this page is linked." } }, { "market": { "zh": "中国大陆、欧盟、日本", "en": "Mainland China, EU, Japan" }, "status": { "zh": "待逐项建立市场记录", "en": "Market record not established" }, "detail": { "zh": "不从美国标签档案推定当地批准、持有人、规格、供应或可售资格。", "en": "No local approval, holder, strength, supply or sale-eligibility conclusion is inferred from the U.S. label archive." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "标签档案能代表现在的产品信息吗？", "en": "Does a label archive represent current product information?" }, "answer": { "zh": "不能自动代表。档案用于定位来源；需要以目标市场的现行官方标签逐项复核。", "en": "Not automatically. The archive locates a source; each point needs verification against the target market’s current official label." } }, { "question": { "zh": "为什么这里不展示价格或原研/仿制结论？", "en": "Why are price and originator/generic conclusions not shown?" }, "answer": { "zh": "这些结论需要产品、剂型、规格、包装、市场、日期和原始记录分别齐全并经人工审核；单一标签文件不足以支持。", "en": "Those conclusions require separately complete and human-reviewed product, dosage-form, strength, pack, market, date and primary-record fields; one label file is insufficient." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "how-to-read-a-drug-label", "regulatory-sources-first" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/micardis/", "en": "https://origindrug.com/en/drugs/micardis/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "entresto", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-30", "status": "published_traceable_archive" }, "names": { "brand": "Entresto", "generic": "沙库巴曲/缬沙坦", "aliases": [ "ENTRESTO", "诺欣妥", "诺欣妥®", "沙库巴曲缬沙坦", "沙库巴曲缬沙坦钠片", "sacubitril valsartan", "sacubitril", "valsartan" ], "marketBrandNames": [ { "name": "诺欣妥®", "market": { "zh": "中国大陆（诺华中国有日期公开资料）", "en": "Mainland China (dated Novartis China public record)" }, "evidenceStatus": "first_party_brand_history", "note": { "zh": "诺华中国有日期公开资料将诺欣妥®对应为沙库巴曲缬沙坦（后续公开资料写作沙库巴曲缬沙坦钠片）。该资料建立中国商品名与通用名线索，但不在本页建立准确中国包装规格。美国 ENTRESTO 档案的 24/26、49/51、97/103 mg 片剂及两种 SPRINKLE 颗粒是美国标签产品身份，不能从“诺欣妥/ENTRESTO”或总毫克数直接跨市场换算。", "en": "A dated Novartis China public record maps Entresto® (诺欣妥®) to sacubitril/valsartan; later first-party material describes sacubitril/valsartan sodium tablets. This establishes a China trade-name and generic-name cue, not an exact Chinese package strength here. The U.S. ENTRESTO dossier's 24/26, 49/51 and 97/103 mg tablets and two SPRINKLE pellet products are U.S.-label identities and cannot be converted across markets from the names or a total milligram number." }, "source": { "id": "src_c9674ad892b8bc2c", "label": "诺华中国：诺欣妥®（沙库巴曲缬沙坦）中国获批公开资料（2021）", "url": "https://www.novartis.com.cn/news/nuoxintuo-was-approved-for-the-indication-of-high-blood-pressure-breaking-through-the-dilemma-of-no-new-drug-for-high-blood-pressure-in-the-past-10-years", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "first_party_release", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" } } ], "mainlandChinaTradeNameCue": { "value": "诺欣妥®", "status": "discovery_cue_requires_target_market_verification", "source": { "id": "src_c9674ad892b8bc2c", "label": "诺华中国：诺欣妥®（沙库巴曲缬沙坦）中国获批公开资料（2021）", "url": "https://www.novartis.com.cn/news/nuoxintuo-was-approved-for-the-indication-of-high-blood-pressure-breaking-through-the-dilemma-of-no-new-drug-for-high-blood-pressure-in-the-past-10-years", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "first_party_release", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" } } }, "identity": { "therapeuticArea": "心血管", "sourceArchiveMarket": "美国当前公开处方药标签（DailyMed SPL v25，2026-07-07 发布；不代表供应）。中国大陆“诺欣妥®”只作为诺华中国有日期公开资料约束的商品名/通用名线索；本页不据此建立准确中国包装规格、当前供应、购买资格或跨市场换算。", "dosageFormClass": "美国标签复方薄膜衣片：沙库巴曲/缬沙坦 24 mg/26 mg、49 mg/51 mg、97 mg/103 mg；另有装于胶囊壳内的口服颗粒 6 mg/6 mg、15 mg/16 mg，属于不同产品形态。中国名称线索不改变这些美国标签产品身份。", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "2015（DailyMed 美国公开标签所列初始批准）", "archiveSponsorText": "Novartis Pharmaceuticals Corporation / DailyMed（NLM）公开标签档案；中国大陆名称线索来自诺华中国有日期公开资料" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-entresto-sacubitril-24mg-valsartan-26mg-60-tablet-bottle-ndc-0078-0659-20", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v25；2026-07-06 生效/更新，2026-07-07 发布", "en": "DailyMed SPL v25; effective/updated 6 Jul 2026 and published 7 Jul 2026" }, "dosageForm": { "zh": "ENTRESTO 沙库巴曲/缬沙坦口服薄膜衣片", "en": "ENTRESTO sacubitril/valsartan oral film-coated tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 0078-0659-20", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片：沙库巴曲 24 mg + 缬沙坦 26 mg；60 片瓶装", "en": "Per tablet: sacubitril 24 mg + valsartan 26 mg; 60-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=000dc81d-ab91-450c-8eae-8eb74e72296f&name=ENTRESTO-06.jpg", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "沙库巴曲", "en": "sacubitril" }, "value": 24, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签量；不是个人片数、换算或调药规则", "en": "labelled amount per tablet; not an individual's tablet count, conversion or adjustment rule" } }, { "ingredient": { "zh": "缬沙坦", "en": "valsartan" }, "value": 26, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签量；不是个人片数、换算或调药规则", "en": "labelled amount per tablet; not an individual's tablet count, conversion or adjustment rule" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 60, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-21", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 60, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_6e8ef8c04b4f3d14", "label": "DailyMed（NLM）：ENTRESTO 沙库巴曲/缬沙坦当前美国公开标签（Novartis；SPL v25）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=000dc81d-ab91-450c-8eae-8eb74e72296f&version=25", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-entresto-sacubitril-49mg-valsartan-51mg-60-tablet-bottle-ndc-0078-0777-20", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v25；2026-07-06 生效/更新，2026-07-07 发布", "en": "DailyMed SPL v25; effective/updated 6 Jul 2026 and published 7 Jul 2026" }, "dosageForm": { "zh": "ENTRESTO 沙库巴曲/缬沙坦口服薄膜衣片", "en": "ENTRESTO sacubitril/valsartan oral film-coated tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 0078-0777-20", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片：沙库巴曲 49 mg + 缬沙坦 51 mg；60 片瓶装", "en": "Per tablet: sacubitril 49 mg + valsartan 51 mg; 60-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=000dc81d-ab91-450c-8eae-8eb74e72296f&name=ENTRESTO-07.jpg", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "沙库巴曲", "en": "sacubitril" }, "value": 49, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签量；不是个人片数、换算或调药规则", "en": "labelled amount per tablet; not an individual's tablet count, conversion or adjustment rule" } }, { "ingredient": { "zh": "缬沙坦", "en": "valsartan" }, "value": 51, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签量；不是个人片数、换算或调药规则", "en": "labelled amount per tablet; not an individual's tablet count, conversion or adjustment rule" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 60, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-21", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 60, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_6e8ef8c04b4f3d14", "label": "DailyMed（NLM）：ENTRESTO 沙库巴曲/缬沙坦当前美国公开标签（Novartis；SPL v25）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=000dc81d-ab91-450c-8eae-8eb74e72296f&version=25", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-entresto-sacubitril-97mg-valsartan-103mg-60-tablet-bottle-ndc-0078-0696-20", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v25；2026-07-06 生效/更新，2026-07-07 发布", "en": "DailyMed SPL v25; effective/updated 6 Jul 2026 and published 7 Jul 2026" }, "dosageForm": { "zh": "ENTRESTO 沙库巴曲/缬沙坦口服薄膜衣片", "en": "ENTRESTO sacubitril/valsartan oral film-coated tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 0078-0696-20", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片：沙库巴曲 97 mg + 缬沙坦 103 mg；60 片瓶装", "en": "Per tablet: sacubitril 97 mg + valsartan 103 mg; 60-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=000dc81d-ab91-450c-8eae-8eb74e72296f&name=ENTRESTO-08.jpg", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "沙库巴曲", "en": "sacubitril" }, "value": 97, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签量；不是个人片数、换算或调药规则", "en": "labelled amount per tablet; not an individual's tablet count, conversion or adjustment rule" } }, { "ingredient": { "zh": "缬沙坦", "en": "valsartan" }, "value": 103, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签量；不是个人片数、换算或调药规则", "en": "labelled amount per tablet; not an individual's tablet count, conversion or adjustment rule" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 60, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-21", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 60, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_6e8ef8c04b4f3d14", "label": "DailyMed（NLM）：ENTRESTO 沙库巴曲/缬沙坦当前美国公开标签（Novartis；SPL v25）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=000dc81d-ab91-450c-8eae-8eb74e72296f&version=25", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-entresto-sprinkle-sacubitril-6mg-valsartan-6mg-60-capsule-bottle-ndc-0078-1231-20", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v25；2026-07-06 生效/更新，2026-07-07 发布", "en": "DailyMed SPL v25; effective/updated 6 Jul 2026 and published 7 Jul 2026" }, "dosageForm": { "zh": "ENTRESTO SPRINKLE 沙库巴曲/缬沙坦口服颗粒（装于胶囊壳内）", "en": "ENTRESTO SPRINKLE sacubitril/valsartan oral pellets in a capsule shell" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 0078-1231-20", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_capsule", "primaryDisplay": { "zh": "每粒所含颗粒：沙库巴曲 6 mg + 缬沙坦 6 mg；60 粒瓶装", "en": "Pellets in each capsule: sacubitril 6 mg + valsartan 6 mg; 60-capsule bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=000dc81d-ab91-450c-8eae-8eb74e72296f&name=ENTRESTO-21.jpg", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "沙库巴曲", "en": "sacubitril" }, "value": 6, "unit": "mg", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒内颗粒的标签量；不是个人粒数、换算或给药操作规则", "en": "labelled amount in the pellets of each capsule; not an individual's capsule count, conversion or administration instruction" } }, { "ingredient": { "zh": "缬沙坦", "en": "valsartan" }, "value": 6, "unit": "mg", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒内颗粒的标签量；不是个人粒数、换算或给药操作规则", "en": "labelled amount in the pellets of each capsule; not an individual's capsule count, conversion or administration instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 60, "countUnit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-21", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 60, "unit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "physicalClues": { "color": { "zh": "白色胶囊帽", "en": "white capsule cap" }, "shape": { "zh": "胶囊壳内装口服颗粒", "en": "capsule shell containing oral pellets" }, "imprint": "04", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_6e8ef8c04b4f3d14", "label": "DailyMed（NLM）：ENTRESTO / ENTRESTO SPRINKLE 沙库巴曲/缬沙坦当前美国公开标签（Novartis；SPL v25）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=000dc81d-ab91-450c-8eae-8eb74e72296f&version=25", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-entresto-sprinkle-sacubitril-15mg-valsartan-16mg-60-capsule-bottle-ndc-0078-1238-20", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v25；2026-07-06 生效/更新，2026-07-07 发布", "en": "DailyMed SPL v25; effective/updated 6 Jul 2026 and published 7 Jul 2026" }, "dosageForm": { "zh": "ENTRESTO SPRINKLE 沙库巴曲/缬沙坦口服颗粒（装于胶囊壳内）", "en": "ENTRESTO SPRINKLE sacubitril/valsartan oral pellets in a capsule shell" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 0078-1238-20", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_capsule", "primaryDisplay": { "zh": "每粒所含颗粒：沙库巴曲 15 mg + 缬沙坦 16 mg；60 粒瓶装", "en": "Pellets in each capsule: sacubitril 15 mg + valsartan 16 mg; 60-capsule bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=000dc81d-ab91-450c-8eae-8eb74e72296f&name=ENTRESTO-22.jpg", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "沙库巴曲", "en": "sacubitril" }, "value": 15, "unit": "mg", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒内颗粒的标签量；不是个人粒数、换算或给药操作规则", "en": "labelled amount in the pellets of each capsule; not an individual's capsule count, conversion or administration instruction" } }, { "ingredient": { "zh": "缬沙坦", "en": "valsartan" }, "value": 16, "unit": "mg", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒内颗粒的标签量；不是个人粒数、换算或给药操作规则", "en": "labelled amount in the pellets of each capsule; not an individual's capsule count, conversion or administration instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 60, "countUnit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-21", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 60, "unit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "physicalClues": { "color": { "zh": "黄色胶囊帽", "en": "yellow capsule cap" }, "shape": { "zh": "胶囊壳内装口服颗粒", "en": "capsule shell containing oral pellets" }, "imprint": "10", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_6e8ef8c04b4f3d14", "label": "DailyMed（NLM）：ENTRESTO / ENTRESTO SPRINKLE 沙库巴曲/缬沙坦当前美国公开标签（Novartis；SPL v25）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=000dc81d-ab91-450c-8eae-8eb74e72296f&version=25", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-entresto-sacubitril-24mg-valsartan-26mg-60-tablet-bottle-ndc-0078-0659-20", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=ENTRESTO-06.jpg&setid=000dc81d-ab91-450c-8eae-8eb74e72296f&type=img", "alt": "ENTRESTO 沙库巴曲/缬沙坦在美国 DailyMed Novartis 公开标签中的 24 mg/26 mg、60 片装包装面板", "archiveMarket": "美国", "labelVersion": "DailyMed 公开标签（Novartis，2026-07 版本）", "presentation": "ENTRESTO 沙库巴曲/缬沙坦薄膜衣片：每片 24 mg/26 mg、60 片装包装面板（NDC 0078-0659-20；DailyMed Novartis 公开标签所列）。", "notice": "此为美国 DailyMed Novartis 公开标签中明确对应 ENTRESTO、沙库巴曲/缬沙坦 24 mg/26 mg、60 片装的包装面板，只帮助核对品牌、两个成分、每片的两组标示量、口服薄膜衣片、包装数量和来源；不用于鉴定真伪，也不证明 49 mg/51 mg、97 mg/103 mg、ENTRESTO SPRINKLE 口服颗粒、其他包装、其他市场标签、当前可得性、原研身份、目标市场批准或可售资格。", "source": { "id": "src_e4242a4ad9626c06", "label": "DailyMed（NLM）：ENTRESTO 沙库巴曲/缬沙坦片及口服颗粒公开标签（Novartis，2026-07 版本）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?lang=en&setid=000dc81d-ab91-450c-8eae-8eb74e72296f", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "ENTRESTO 说明书放大阅读：24/26、49/51、97/103 是两个成分的产品身份", "en": "ENTRESTO label reading: 24/26, 49/51 and 97/103 identify two ingredients in one product" }, "summary": { "zh": "本模块以美国 DailyMed 公开标签和 Novartis 包装图为阅读入口，帮助核对 ENTRESTO、沙库巴曲/缬沙坦、每片的双数字、薄膜衣片、包装与目标市场。它不提供任何人的片数、联用、转换或症状处理方案。", "en": "This module uses the U.S. DailyMed public label and Novartis package image to check ENTRESTO, sacubitril/valsartan, the two numbers per tablet, film-coated tablet, package and target market. It does not provide an individual's tablet count, combination, switching or symptom-management plan." }, "checks": [ { "zh": "24 mg/26 mg、49 mg/51 mg、97 mg/103 mg 分别是沙库巴曲和缬沙坦两种成分的标示量。不能把其中一个数字、总毫克数，或另一种缬沙坦产品的数字，当作可自行拼量、减半或替换的依据。", "en": "24 mg/26 mg, 49 mg/51 mg and 97 mg/103 mg state the labelled amounts of two ingredients: sacubitril and valsartan. Neither one number, a total milligram number nor the number on another valsartan product is a basis for self-combining, halving or substituting." }, { "zh": "美国标签把口服薄膜衣片与 ENTRESTO SPRINKLE 口服颗粒分开列出。口服颗粒的包装文字还明确要求打开胶囊壳给药、不要整粒吞服、不要咀嚼或压碎颗粒；这不表示薄膜衣片也能按同样方式处理。任何掰开、研碎、打开或换剂型的问题都要由准确产品的现行标签和药师确认。", "en": "The U.S. label lists film-coated tablets separately from ENTRESTO SPRINKLE oral pellets. Pellet packaging states that the capsule shell is opened for administration and the pellets are not swallowed whole, chewed or crushed; that does not establish the same handling for the film-coated tablet. Any splitting, crushing, opening or dosage-form switch must be confirmed from the current label for the exact product and a pharmacist." }, { "zh": "标签明确列出与 ACE 抑制剂、其他 ARB、含钾补充剂/代盐、保钾利尿剂、NSAIDs、锂盐等的关键核对事项。正在服用降压、心衰、利尿、止痛或补充剂产品时，应把完整药单和实际包装交由医生或药师核对；不要因名称相近自行叠加、停用或替换。", "en": "The label identifies important checks involving ACE inhibitors, other ARBs, potassium supplements/salt substitutes, potassium-sparing diuretics, NSAIDs and lithium. With blood-pressure, heart-failure, diuretic, pain or supplement products, have a clinician or pharmacist review the complete medicine list and actual packs; do not self-add, stop or substitute based on similar names." }, { "zh": "该标签对与 ACE 抑制剂转换和部分既往反应有明确限制，并含妊娠相关警示。这里不把标签要求变成个人转换时间表或治疗决定；开始、停用、转换、漏服或任何新不适，都应按开方团队、药师和目标市场现行标签处理。", "en": "The label contains explicit restrictions for switching with ACE inhibitors and for some prior reactions, as well as pregnancy-related warnings. This page does not turn those label requirements into an individual transition schedule or treatment decision; starting, stopping, switching, missed doses or any new concern must be addressed with the prescribing team, pharmacist and current target-market label." } ], "source": { "id": "src_e4242a4ad9626c06", "label": "DailyMed（NLM）：ENTRESTO 沙库巴曲/缬沙坦片及口服颗粒公开标签（Novartis，2026-07 版本）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?lang=en&setid=000dc81d-ab91-450c-8eae-8eb74e72296f", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "沙库巴曲/缬沙坦怎样起作用：标签描述两条同时存在的药理路径", "en": "How sacubitril/valsartan works: the label describes two simultaneous pharmacologic pathways" }, "summary": { "zh": "DailyMed 标签将 ENTRESTO 描述为脑啡肽酶抑制剂沙库巴曲与血管紧张素 II 受体阻断剂缬沙坦的复方；标签进一步说明其通过沙库巴曲活性代谢物抑制脑啡肽酶，并由缬沙坦阻断 AT1 受体。这解释标签中的药理路径，不判断个人心衰原因、是否适合使用、片数、联用或转换方案。", "en": "The DailyMed label describes ENTRESTO as a combination of the neprilysin inhibitor sacubitril and the angiotensin II receptor blocker valsartan; it further states that sacubitril's active metabolite inhibits neprilysin while valsartan blocks the AT1 receptor. This explains label-described pharmacology, not an individual's cause of heart failure, suitability, tablet count, combination or switching plan." }, "checks": [ { "zh": "“两条作用路径”不表示可从机制推导个人该选哪种心脏药、是否需要加药，或自行把 ENTRESTO 与 ACE 抑制剂、ARB 或其他降压药叠加。完整病史、血压、肾功能、化验、既往反应和全部用药必须由专业人员一起核对。", "en": "“Two pathways” does not let a mechanism page choose a person's heart medicine, decide whether to add a medicine or self-combine ENTRESTO with an ACE inhibitor, ARB or another blood-pressure medicine. History, blood pressure, kidney function, tests, prior reactions and all medicines require professional review together." }, { "zh": "复方中的缬沙坦与单成分缬沙坦产品共享一个成分，不表示可以凭包装数字、机制或名称自行互换、补用、轮换或并用；完整产品、剂型和现行标签必须分别核对。", "en": "Valsartan in the combination shares an ingredient with single-ingredient valsartan products, but package numbers, mechanism or names do not establish self-interchangeability, catch-up use, alternation or co-use; the complete product, dosage form and current label must be checked separately." }, { "zh": "机制页面也不能判断头晕、晕厥、面部或咽喉肿胀、呼吸困难、明显乏力或其他不适的原因。出现急性或严重不适时，应优先使用当地紧急医疗支持；不要依据机制文字自行继续、停用或更改方案。", "en": "A mechanism page cannot determine the cause of dizziness, fainting, face or throat swelling, breathing difficulty, marked weakness or another symptom. With an acute or severe concern, prioritise local urgent medical support; do not self-continue, stop or change treatment from mechanism wording." } ], "source": { "id": "src_e4242a4ad9626c06", "label": "DailyMed（NLM）：ENTRESTO 沙库巴曲/缬沙坦公开标签（Clinical Pharmacology，2026-07 版本）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?lang=en&setid=000dc81d-ab91-450c-8eae-8eb74e72296f", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "Entresto", "generic": "沙库巴曲/缬沙坦", "dosageFormClass": "美国标签复方薄膜衣片：沙库巴曲/缬沙坦 24 mg/26 mg、49 mg/51 mg、97 mg/103 mg；另有装于胶囊壳内的口服颗粒 6 mg/6 mg、15 mg/16 mg，属于不同产品形态。中国名称线索不改变这些美国标签产品身份。" }, "labelSource": { "id": "src_e4242a4ad9626c06", "label": "DailyMed（NLM）：ENTRESTO 沙库巴曲/缬沙坦片及口服颗粒公开标签（Novartis，2026-07 版本）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?lang=en&setid=000dc81d-ab91-450c-8eae-8eb74e72296f", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "productRoutes": [ { "source": { "id": "src_e4242a4ad9626c06", "label": "DailyMed（NLM）：ENTRESTO 沙库巴曲/缬沙坦片及口服颗粒公开标签（Novartis，2026-07 版本）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?lang=en&setid=000dc81d-ab91-450c-8eae-8eb74e72296f", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "DailyMed 的 ENTRESTO（sacubitril/valsartan）美国公开标签将其列为复方口服薄膜衣片，分别标示沙库巴曲/缬沙坦 24 mg/26 mg、49 mg/51 mg、97 mg/103 mg；同一标签还列有口服颗粒产品。页面帮助读者把两个成分、两组标示量、准确剂型、包装与目标市场一起核对；不据此生成个人服用数量、加减量、联用、转换或停药方案。", "history": "“24/26”“49/51”“97/103”是两个活性成分各自的标示量，不是一个可自行相加、拆分或与其他缬沙坦产品互换的单一数字。美国标签还把口服薄膜衣片与 ENTRESTO SPRINKLE 口服颗粒分开列示；共享品牌或成分不表示两种产品可按 mg 对 mg 自行替换。", "sourceDocuments": [ { "id": "src_e4242a4ad9626c06", "label": "DailyMed（NLM）：ENTRESTO 沙库巴曲/缬沙坦片及口服颗粒公开标签（Novartis，2026-07 版本）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?lang=en&setid=000dc81d-ab91-450c-8eae-8eb74e72296f", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_5ed30b676fbb9773", "label": "FDA Drugs@FDA 官方检索入口", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_lookup_entry", "documentKind": "regulatory_lookup", "market": "US", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } ], "applicationNumber": "NDA 207620 / 218591", "approvalTimeline": [ { "date": "2015", "title": { "zh": "FDA 标签所列美国初始批准年份", "en": "Initial U.S. approval year listed in the FDA label" }, "detail": { "zh": "本页链接的 FDA 标签档案列示 Initial U.S. Approval: 2015。该历史定位不等同于当前批准、可得性、持有人或其他市场状态。", "en": "The FDA label archive linked here lists Initial U.S. Approval: 2015. This historical locator is not a conclusion about current approval, availability, holder or another market." }, "source": { "id": "src_e4242a4ad9626c06", "label": "DailyMed: ENTRESTO public label archive", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?lang=en&setid=000dc81d-ab91-450c-8eae-8eb74e72296f", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, { "date": "2026-07", "title": { "zh": "FDA 标签档案版本", "en": "FDA label archive version" }, "detail": { "zh": "本页链接 2026-07 的 FDA 标签档案作为可复核阅读入口。现行标签、规格、适应症和安全信息必须另行以目标市场当前文件核对。", "en": "This page links the 2026-07 FDA label archive as a traceable reading entry point. Current labeling, strength, indication and safety information require separate verification against the target market’s current document." }, "source": { "id": "src_e4242a4ad9626c06", "label": "DailyMed: ENTRESTO public label archive", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?lang=en&setid=000dc81d-ab91-450c-8eae-8eb74e72296f", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "已链接公开标签档案", "en": "Public label archive linked" }, "detail": { "zh": "仅对应本页所列 FDA 文件。", "en": "Only the FDA document listed on this page is linked." } }, { "market": { "zh": "中国大陆、欧盟、日本", "en": "Mainland China, EU, Japan" }, "status": { "zh": "待逐项建立市场记录", "en": "Market record not established" }, "detail": { "zh": "不从美国标签档案推定当地批准、持有人、规格、供应或可售资格。", "en": "No local approval, holder, strength, supply or sale-eligibility conclusion is inferred from the U.S. label archive." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "标签档案能代表现在的产品信息吗？", "en": "Does a label archive represent current product information?" }, "answer": { "zh": "不能自动代表。档案用于定位来源；需要以目标市场的现行官方标签逐项复核。", "en": "Not automatically. The archive locates a source; each point needs verification against the target market’s current official label." } }, { "question": { "zh": "为什么这里不展示价格或原研/仿制结论？", "en": "Why are price and originator/generic conclusions not shown?" }, "answer": { "zh": "这些结论需要产品、剂型、规格、包装、市场、日期和原始记录分别齐全并经人工审核；单一标签文件不足以支持。", "en": "Those conclusions require separately complete and human-reviewed product, dosage-form, strength, pack, market, date and primary-record fields; one label file is insufficient." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "how-to-read-a-drug-label", "regulatory-sources-first" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/entresto/", "en": "https://origindrug.com/en/drugs/entresto/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "procardia-xl", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-20", "status": "published_traceable_archive" }, "names": { "brand": "Procardia XL", "generic": "硝苯地平", "aliases": [ "拜新同", "nifedipine", "nifedipine GITS", "nifedipine extended release", "硝苯地平控释片", "硝苯地平" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": { "value": "拜新同®", "status": "discovery_cue_requires_target_market_verification", "source": { "id": "src_a92ef31704391cdb", "label": "烟台市人民政府：2024 年药品规格及价格记录中的拜新同／硝苯地平控释片 30 mg 记录", "url": "https://www.yantai.gov.cn/art/2023/12/29/art_67240_3168957.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "government_medicine_listing", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-12", "reviewedAt": "2026-09-12" } } }, "identity": { "therapeuticArea": "心血管", "sourceArchiveMarket": "美国公开监管标签档案", "dosageFormClass": "口服控释片（GITS；30、60、90 mg；DailyMed 2025 标签所列）", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "1989（DailyMed 美国标签档案列示 NDA019684 的起始日期）", "archiveSponsorText": "FDA / DailyMed 公开监管标签档案" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [ "nifedipine immediate release", "immediate release nifedipine", "procardia capsule", "nifedipine capsule", "硝苯地平普通片", "硝苯地平胶囊", "硝苯地平速释" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-procardia-xl-gits-tablet-30mg-ndc-0069-2650-66", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v19，2025-12-16 更新；2025-12-17 发布", "en": "DailyMed SPL v19, updated 16 Dec 2025 and published 17 Dec 2025" }, "dosageForm": { "zh": "PROCARDIA XL 硝苯地平 GITS 控释口服片", "en": "PROCARDIA XL nifedipine GITS controlled-release oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 0069-2650-66", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片标示 30 mg；每片实际含 33 mg；100 片瓶装（GITS 控释片）", "en": "30 mg labelled strength; 33 mg tablet content; 100-tablet bottle (GITS controlled-release tablet)" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=8ebcb33c-f43b-4b36-9f94-9774b2a59e06&name=procardia-xl-03.jpg", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "硝苯地平", "en": "nifedipine" }, "value": 30, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标示给药强度；不是个人片数或换算规则", "en": "labelled delivery strength per tablet; not an individual tablet-count or conversion rule" } }, { "ingredient": { "zh": "硝苯地平", "en": "nifedipine" }, "value": 33, "unit": "mg", "basisCode": "tablet_content", "basisLabel": { "zh": "标签说明的每片实际含量；与标示给药强度分开阅读", "en": "tablet content stated by the label; read separately from labelled delivery strength" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "100 片瓶装", "en": "100-tablet bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": null, "package": { "count": 100, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "玫瑰粉色", "en": "rose-pink" }, "shape": { "zh": "圆形、双凸薄膜衣控释片", "en": "round biconvex film-coated controlled-release tablet" }, "imprint": null, "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_5f6033ab156546bf", "label": "DailyMed（NLM）：PROCARDIA XL 硝苯地平 30 mg GITS、100 片瓶装（Pfizer；SPL v19，2025-12-16 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8ebcb33c-f43b-4b36-9f94-9774b2a59e06", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-procardia-xl-gits-tablet-60mg-ndc-0069-2660-66", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v19，2025-12-16 更新；2025-12-17 发布", "en": "DailyMed SPL v19, updated 16 Dec 2025 and published 17 Dec 2025" }, "dosageForm": { "zh": "PROCARDIA XL 硝苯地平 GITS 控释口服片", "en": "PROCARDIA XL nifedipine GITS controlled-release oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 0069-2660-66", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片标示 60 mg；每片实际含 66 mg；100 片瓶装（GITS 控释片）", "en": "60 mg labelled strength; 66 mg tablet content; 100-tablet bottle (GITS controlled-release tablet)" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=8ebcb33c-f43b-4b36-9f94-9774b2a59e06&name=procardia-xl-04.jpg", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "硝苯地平", "en": "nifedipine" }, "value": 60, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标示给药强度；不是个人片数或换算规则", "en": "labelled delivery strength per tablet; not an individual tablet-count or conversion rule" } }, { "ingredient": { "zh": "硝苯地平", "en": "nifedipine" }, "value": 66, "unit": "mg", "basisCode": "tablet_content", "basisLabel": { "zh": "标签说明的每片实际含量；与标示给药强度分开阅读", "en": "tablet content stated by the label; read separately from labelled delivery strength" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "100 片瓶装", "en": "100-tablet bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": null, "package": { "count": 100, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "玫瑰粉色", "en": "rose-pink" }, "shape": { "zh": "圆形、双凸薄膜衣控释片", "en": "round biconvex film-coated controlled-release tablet" }, "imprint": null, "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_5f6033ab156546bf", "label": "DailyMed（NLM）：PROCARDIA XL 硝苯地平 60 mg GITS、100 片瓶装（Pfizer；SPL v19，2025-12-16 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8ebcb33c-f43b-4b36-9f94-9774b2a59e06", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-procardia-xl-gits-tablet-90mg-ndc-0069-2670-66", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v19，2025-12-16 更新；2025-12-17 发布", "en": "DailyMed SPL v19, updated 16 Dec 2025 and published 17 Dec 2025" }, "dosageForm": { "zh": "PROCARDIA XL 硝苯地平 GITS 控释口服片", "en": "PROCARDIA XL nifedipine GITS controlled-release oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 0069-2670-66", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片标示 90 mg；每片实际含 99 mg；100 片瓶装（GITS 控释片）", "en": "90 mg labelled strength; 99 mg tablet content; 100-tablet bottle (GITS controlled-release tablet)" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=8ebcb33c-f43b-4b36-9f94-9774b2a59e06&name=procardia-xl-05.jpg", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "硝苯地平", "en": "nifedipine" }, "value": 90, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标示给药强度；不是个人片数或换算规则", "en": "labelled delivery strength per tablet; not an individual tablet-count or conversion rule" } }, { "ingredient": { "zh": "硝苯地平", "en": "nifedipine" }, "value": 99, "unit": "mg", "basisCode": "tablet_content", "basisLabel": { "zh": "标签说明的每片实际含量；与标示给药强度分开阅读", "en": "tablet content stated by the label; read separately from labelled delivery strength" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "100 片瓶装", "en": "100-tablet bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": null, "package": { "count": 100, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "玫瑰粉色", "en": "rose-pink" }, "shape": { "zh": "圆形、双凸薄膜衣控释片", "en": "round biconvex film-coated controlled-release tablet" }, "imprint": null, "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_5f6033ab156546bf", "label": "DailyMed（NLM）：PROCARDIA XL 硝苯地平 90 mg GITS、100 片瓶装（Pfizer；SPL v19，2025-12-16 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8ebcb33c-f43b-4b36-9f94-9774b2a59e06", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-procardia-xl-gits-tablet-30mg-ndc-0069-2650-66", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=8ebcb33c-f43b-4b36-9f94-9774b2a59e06&name=procardia-xl-03.jpg", "alt": "PROCARDIA XL 30 mg GITS 硝苯地平控释片在美国 DailyMed 公开标签中的 Pfizer 100 片瓶装主展示图", "archiveMarket": "美国", "labelVersion": "DailyMed 公开标签（2025-12 更新；包装图稿标注 2023-11）", "presentation": "PROCARDIA XL 30 mg GITS、100 片瓶装主展示图（DailyMed 公开标签所列；Pfizer 标签图）。", "notice": "此为美国 DailyMed 公开标签中明确对应 PROCARDIA XL 30 mg GITS、100 片瓶装的 Pfizer 包装文字图，只帮助核对品牌、通用名、标示强度、控释片、包装数量和来源；不用于鉴定真伪，也不证明 60 mg/90 mg、其他包装、其他市场标签、当前包装、原研身份、目标市场批准或可售资格。", "source": { "id": "src_5f6033ab156546bf", "label": "DailyMed（NLM）：PROCARDIA XL 公开标签（Pfizer，2025-12 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8ebcb33c-f43b-4b36-9f94-9774b2a59e06", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "PROCARDIA XL / 硝苯地平控释片说明书放大阅读：缓释外壳、30/60/90 mg 与“不能掰开”", "en": "PROCARDIA XL label reading: controlled-release shell, 30/60/90 mg and why tablets are not split" }, "summary": { "zh": "本模块以 FDA 2021 和 DailyMed 2025 美国公开标签为阅读入口，帮助核对 PROCARDIA XL、硝苯地平、GITS 控释片、30/60/90 mg 和包装文字；它不把这些信息转换为个人开始、加减、联用、换药或停药方案。", "en": "This module uses the 2021 FDA and 2025 U.S. DailyMed public labels as reading entry points. It helps check PROCARDIA XL, nifedipine, GITS controlled-release tablets, 30/60/90 mg and package text; it does not convert them into an individual start, adjustment, combination, switch or stop plan." }, "checks": [ { "zh": "30、60、90 mg 是标签所列控释片的标示强度，不是可以按经验相加、对半或用另一种硝苯地平产品换算的片数规则。任何产品变更必须同时核对准确处方、剂型、市场和现行标签。", "en": "30, 60 and 90 mg are labelled strengths for controlled-release tablets, not rules for adding, halving or converting tablet counts by experience with another nifedipine product. Any product change requires the exact prescription, dosage form, market and current label to be checked together." }, { "zh": "DailyMed 标签明确写明控释片应整片吞服，不咀嚼、不掰分、不压碎。这里的“不能掰开”来自此准确控释产品的释放设计，不能被泛化为其他片剂的操作结论。", "en": "The DailyMed label explicitly states that the controlled-release tablet should be swallowed whole, not chewed, divided or crushed. This ‘do not split’ statement comes from the release design of this exact product and cannot be generalised to another tablet." }, { "zh": "标签说明，药物释放完成后，偶尔在粪便中看到看似药片的空壳不必据此自行补服、停用或改变方案；任何担忧都应与实际包装和完整药单一并交由药师或开方团队确认。", "en": "The label explains that, after release is complete, something that looks like a tablet shell may occasionally be seen in stool. That is not a reason to self-dose again, stop or change the plan; bring any concern, the actual package and the complete medicine list to a pharmacist or prescribing team." }, { "zh": "同类降压药、β 受体阻滞剂、其他心血管药、葡萄柚制品或多药并用都可能带来需要专业人员核对的问题。不要因为包装都写“降压”或都含硝苯地平就自行叠加、轮换或替代；头晕、胸部不适、晕厥或明显不适时应及时使用当地医疗支持。", "en": "Related blood-pressure medicines, beta blockers, other cardiovascular medicines, grapefruit products or multiple medicines can all raise questions needing professional review. Do not self-combine, alternate or substitute merely because packages mention blood pressure or contain nifedipine; seek timely local medical support for dizziness, chest discomfort, fainting or marked illness." } ], "source": { "id": "src_5f6033ab156546bf", "label": "DailyMed（NLM）：PROCARDIA XL 公开标签（患者信息与产品展示）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8ebcb33c-f43b-4b36-9f94-9774b2a59e06", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "硝苯地平控释片怎样起作用：影响钙离子进入血管平滑肌和心肌细胞", "en": "How controlled-release nifedipine works: it affects calcium-ion entry into vascular smooth and cardiac muscle cells" }, "summary": { "zh": "DailyMed 标签将硝苯地平描述为钙离子内流抑制剂（慢通道阻滞剂/钙离子拮抗剂），可选择性抑制钙离子跨细胞膜进入血管平滑肌和心肌细胞。它解释药理路径，不预测个人血压变化、适用性、片数、联用或换药。", "en": "The DailyMed label describes nifedipine as a calcium-ion influx inhibitor (slow-channel blocker/calcium-ion antagonist) that selectively inhibits transmembrane calcium-ion entry into vascular smooth and cardiac muscle cells. It explains a pharmacologic pathway; it does not predict an individual's blood-pressure change, suitability, tablet count, combination or switch." }, "checks": [ { "zh": "“影响钙离子进入”解释了为何硝苯地平属于钙通道阻滞剂，但不能从中推导某个人该选普通片、控释片还是另一种降压药。剂型、既往反应、疾病情况、完整药单和现行标签都需要一起复核。", "en": "‘Affects calcium-ion entry’ explains why nifedipine is a calcium-channel blocker, but cannot determine whether an individual should use an immediate-release tablet, a controlled-release tablet or another blood-pressure medicine. Dosage form, prior reactions, conditions, complete medicine list and current label all need review together." }, { "zh": "与其他降压药有相近目标或共同影响血压，不表示可以自行同日叠加、隔日轮换或从普通制剂改成控释制剂。机制不能替代对具体产品、血压记录和相互作用的专业判断。", "en": "Having a related target or shared effect on blood pressure with another medicine does not permit same-day self-combination, alternate-day rotation or a change from an immediate-release to a controlled-release product. Mechanism cannot replace professional judgment about exact products, blood-pressure records and interactions." }, { "zh": "控释机制也不是个人用药时间表，更不能用来决定何时自行加量、减量或停药。出现头晕、晕厥、胸部不适或其他急性变化，应使用当地急诊与专业支持，而不是根据机制页面自行调整。", "en": "A controlled-release mechanism is not an individual timetable and cannot decide when to self-increase, reduce or stop. With dizziness, fainting, chest discomfort or another acute change, use local urgent and professional support rather than self-adjusting from a mechanism page." } ], "source": { "id": "src_5f6033ab156546bf", "label": "DailyMed（NLM）：PROCARDIA XL 公开标签（临床药理）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8ebcb33c-f43b-4b36-9f94-9774b2a59e06", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "Procardia XL", "generic": "硝苯地平", "dosageFormClass": "口服控释片（GITS；30、60、90 mg；DailyMed 2025 标签所列）" }, "labelSource": { "id": "src_5f6033ab156546bf", "label": "DailyMed（NLM）：PROCARDIA XL 公开标签（Pfizer，2025-12 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8ebcb33c-f43b-4b36-9f94-9774b2a59e06", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "productRoutes": [ { "source": { "id": "src_5f6033ab156546bf", "label": "DailyMed（NLM）：PROCARDIA XL 公开标签（Pfizer，2025-12 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8ebcb33c-f43b-4b36-9f94-9774b2a59e06", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_40806ef1e083dfd5", "label": "FDA：PROCARDIA XL 2021 美国标签（NDA 019684）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/019684s033lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "DailyMed 的 PROCARDIA XL（nifedipine）2025 美国公开标签将其列为口服控释片（GITS），并列示 30、60、90 mg 规格及 NDA019684 的历史记录。本页用于放大阅读这一美国公开档案；不将其延伸为中国大陆或其他市场的当前批准、中文商品名、持有人、原研关系、供应、价格或可售资格结论。", "history": "中文检索线索“拜新同”与英文名称、硝苯地平、控释/GITS、每片标示强度和目标市场必须一起核对。缓释/控释设计是产品身份的一部分；不能仅凭同一通用名、相近盒子或相同 mg 将其与普通或其他改良释放硝苯地平产品自动等同。", "sourceDocuments": [ { "id": "src_40806ef1e083dfd5", "label": "FDA：PROCARDIA XL 2021 美国标签（NDA 019684）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/019684s033lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_5f6033ab156546bf", "label": "DailyMed（NLM）：PROCARDIA XL 公开标签（Pfizer，2025-12 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8ebcb33c-f43b-4b36-9f94-9774b2a59e06", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_5ed30b676fbb9773", "label": "FDA Drugs@FDA 官方检索入口", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_lookup_entry", "documentKind": "regulatory_lookup", "market": "US", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } ], "applicationNumber": "NDA 019684", "approvalTimeline": [ { "date": "1989", "title": { "zh": "FDA 标签所列美国初始批准年份", "en": "Initial U.S. approval year listed in the FDA label" }, "detail": { "zh": "本页链接的 FDA 标签档案列示 Initial U.S. Approval: 1989。该历史定位不等同于当前批准、可得性、持有人或其他市场状态。", "en": "The FDA label archive linked here lists Initial U.S. Approval: 1989. This historical locator is not a conclusion about current approval, availability, holder or another market." }, "source": { "id": "src_40806ef1e083dfd5", "label": "FDA: PROCARDIA XL label archive", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/019684s033lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, { "date": "2021", "title": { "zh": "FDA 标签档案版本", "en": "FDA label archive version" }, "detail": { "zh": "本页链接 2021 的 FDA 标签档案作为可复核阅读入口。现行标签、规格、适应症和安全信息必须另行以目标市场当前文件核对。", "en": "This page links the 2021 FDA label archive as a traceable reading entry point. Current labeling, strength, indication and safety information require separate verification against the target market’s current document." }, "source": { "id": "src_40806ef1e083dfd5", "label": "FDA: PROCARDIA XL label archive", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/019684s033lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "已链接公开标签档案", "en": "Public label archive linked" }, "detail": { "zh": "仅对应本页所列 FDA 文件。", "en": "Only the FDA document listed on this page is linked." } }, { "market": { "zh": "中国大陆、欧盟、日本", "en": "Mainland China, EU, Japan" }, "status": { "zh": "待逐项建立市场记录", "en": "Market record not established" }, "detail": { "zh": "不从美国标签档案推定当地批准、持有人、规格、供应或可售资格。", "en": "No local approval, holder, strength, supply or sale-eligibility conclusion is inferred from the U.S. label archive." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "标签档案能代表现在的产品信息吗？", "en": "Does a label archive represent current product information?" }, "answer": { "zh": "不能自动代表。档案用于定位来源；需要以目标市场的现行官方标签逐项复核。", "en": "Not automatically. The archive locates a source; each point needs verification against the target market’s current official label." } }, { "question": { "zh": "为什么这里不展示价格或原研/仿制结论？", "en": "Why are price and originator/generic conclusions not shown?" }, "answer": { "zh": "这些结论需要产品、剂型、规格、包装、市场、日期和原始记录分别齐全并经人工审核；单一标签文件不足以支持。", "en": "Those conclusions require separately complete and human-reviewed product, dosage-form, strength, pack, market, date and primary-record fields; one label file is insufficient." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "how-to-read-a-drug-label", "regulatory-sources-first" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/procardia-xl/", "en": "https://origindrug.com/en/drugs/procardia-xl/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "plendil", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-22", "status": "published_traceable_archive" }, "names": { "brand": "Plendil", "generic": "非洛地平", "aliases": [ "PLENDIL", "波依定", "felodipine", "非洛地平", "非洛地平缓释片" ], "marketBrandNames": [ { "name": "波依定", "market": { "zh": "中国大陆（有日期政府公开记录）", "en": "Mainland China (dated government public record)" }, "evidenceStatus": "dated_public_record", "note": { "zh": "江阴市政府 2022 年常用药品价格信息将波依定列为阿斯利康非洛地平缓释片 2.5 mg／5 mg。该记录只支持中文商品名、通用名、缓释剂型和有日期规格线索，不替代 NMPA 当前批准、说明书、准确包装、库存或可售资格核验。", "en": "A 2022 Jiangyin government medicine-price record lists 波依定 as AstraZeneca felodipine sustained-release tablets in 2.5 mg and 5 mg strengths. It supports only a dated Chinese trade-name, generic-name, modified-release-form and strength cue; it does not replace a current NMPA approval, leaflet, exact-pack, stock or sale-eligibility check." }, "source": { "id": "src_98e45c6ee4b9de6a", "label": "江阴市人民政府：2022 年常用药品价格信息列示波依定／非洛地平缓释片（有日期名称线索）", "url": "https://www.jiangyin.gov.cn/doc/2022/08/24/1067954.shtml", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "government_price_record", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-31", "reviewedAt": "2026-08-31" } } ], "mainlandChinaTradeNameCue": { "value": "波依定®", "status": "discovery_cue_requires_target_market_verification", "source": { "id": "src_092a0ae4c3622ec8", "label": "青岛市人民政府：2024 年医院药品价格记录中的波依定／非洛地平缓释片 5 mg 记录", "url": "https://www.qingdao.gov.cn/ywdt/zwzl/ggqsydwgk/wsjk_208049/yy/qdsdsyy/zzbs/jg/202409/t20240913_8268896.shtml", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "government_medicine_listing", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-12", "reviewedAt": "2026-09-12" } } }, "identity": { "therapeuticArea": "心血管", "sourceArchiveMarket": "美国 PLENDIL（felodipine）缓释片历史公开标签，2012-10 修订；FDA 文件页面明确提示该标签可能不是最新获批版本。本档案不以此推定任何市场的当前批准、供应或可得性。", "dosageFormClass": "缓释口服片：2.5 mg、5 mg、10 mg（FDA 2012 美国历史标签所列）", "dosageFormClassCode": "oral_modified_release", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "美国 FDA 历史标签：2012-10 修订", "archiveSponsorText": "AstraZeneca LP / FDA 美国历史公开标签" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [ "felodipine immediate-release", "非洛地平即释制剂" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-plendil-felodipine-er-2-5mg-ndc-0186-0450-58", "marketCode": "US", "labelVersion": { "zh": "FDA 美国历史标签（2012-10 修订）", "en": "FDA U.S. historical label (revised Oct 2012)" }, "dosageForm": { "zh": "非洛地平缓释口服片", "en": "felodipine extended-release oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 0186-0450-58", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片非洛地平 2.5 mg；100 片瓶装（历史标签文字）", "en": "Felodipine 2.5 mg per tablet; 100-tablet bottle (historical label text)" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "非洛地平", "en": "felodipine" }, "value": 2.5, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片历史标签量；不是个人片数或调整指令", "en": "historical labelled amount per tablet; not an individual tablet count or adjustment instruction" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": null, "package": { "count": 100, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "浅红褐色", "en": "light reddish-brown" }, "shape": { "zh": "圆形双凸片", "en": "round biconvex tablet" }, "imprint": "450 / PLENDIL", "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_6125ca4152d0b775", "label": "FDA：PLENDIL（felodipine）美国历史标签（2012-10 修订；2.5 mg 历史 NDC 面板）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019834s025lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-plendil-felodipine-er-5mg-ndc-0186-0451-58", "marketCode": "US", "labelVersion": { "zh": "FDA 美国历史标签（2012-10 修订）", "en": "FDA U.S. historical label (revised Oct 2012)" }, "dosageForm": { "zh": "非洛地平缓释口服片", "en": "felodipine extended-release oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 0186-0451-58", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片非洛地平 5 mg；100 片瓶装（历史标签文字）", "en": "Felodipine 5 mg per tablet; 100-tablet bottle (historical label text)" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "非洛地平", "en": "felodipine" }, "value": 5, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片历史标签量；不是个人片数或调整指令", "en": "historical labelled amount per tablet; not an individual tablet count or adjustment instruction" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": null, "package": { "count": 100, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "粉红色", "en": "pink" }, "shape": { "zh": "圆形双凸片", "en": "round biconvex tablet" }, "imprint": "451 / PLENDIL", "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_6125ca4152d0b775", "label": "FDA：PLENDIL（felodipine）美国历史标签（2012-10 修订；5 mg 历史 NDC 面板）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019834s025lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-plendil-felodipine-er-10mg-ndc-0186-0452-58", "marketCode": "US", "labelVersion": { "zh": "FDA 美国历史标签（2012-10 修订）", "en": "FDA U.S. historical label (revised Oct 2012)" }, "dosageForm": { "zh": "非洛地平缓释口服片", "en": "felodipine extended-release oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 0186-0452-58", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片非洛地平 10 mg；100 片瓶装（历史标签文字）", "en": "Felodipine 10 mg per tablet; 100-tablet bottle (historical label text)" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "非洛地平", "en": "felodipine" }, "value": 10, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片历史标签量；不是个人片数或调整指令", "en": "historical labelled amount per tablet; not an individual tablet count or adjustment instruction" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": null, "package": { "count": 100, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "红褐色", "en": "reddish-brown" }, "shape": { "zh": "圆形双凸片", "en": "round biconvex tablet" }, "imprint": "452 / PLENDIL", "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_6125ca4152d0b775", "label": "FDA：PLENDIL（felodipine）美国历史标签（2012-10 修订；10 mg 历史 NDC 面板）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019834s025lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "status": "withheld_repackaged_or_non_exact_visual", "title": { "zh": "已核验历史标签文字，但未保留可一一对应的官方包装图，故不展示包装图片", "en": "Historical label text was reviewed, but no one-to-one official package image was retained, so no package visual is shown" }, "summary": { "zh": "本档案只保留 FDA 2012 年历史标签中的 PLENDIL、非洛地平缓释片、三个历史 NDC、强度和瓶装文字；该文件明确可能不是最新获批标签。未将零售图、无法对应具体强度/NDC 的图或其他市场图片呈现为准确原品牌包装，因此页面不展示包装图。", "en": "This dossier retains only PLENDIL, felodipine extended-release tablets, three historical NDCs, strengths and bottle text from the FDA 2012 historical label, which explicitly may not be the latest approved label. No retail image, image without a specific strength/NDC match or another-market image is presented as an exact original-brand package, so no package visual is shown." }, "source": { "id": "src_6125ca4152d0b775", "label": "FDA：PLENDIL（felodipine）美国历史标签（2012-10 修订）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019834s025lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "PLENDIL 说明书放大阅读：2.5、5、10 mg 是历史缓释片身份，不是“该吃几片”", "en": "PLENDIL label reading: 2.5, 5 and 10 mg identify historical extended-release tablets; they do not answer “how many tablets”" }, "summary": { "zh": "本模块只阅读 FDA 2012 年美国历史标签中的 PLENDIL、非洛地平缓释片、三个历史 NDC、每片标签量与瓶装文字。该文件明确可能不是最新获批标签；页面不提供个人片数、开始、停用、换药、联用或购买方案。", "en": "This module reads only PLENDIL, felodipine extended-release tablets, three historical NDCs, labelled amount per tablet and bottle text in an FDA 2012 U.S. historical label. The document explicitly may not be the latest approved label; this page provides no individual tablet count, initiation, stopping, switching, co-use or purchase plan." }, "checks": [ { "zh": "把 PLENDIL、非洛地平、缓释片、实际强度、NDC 和目标市场一起核对。2.5、5、10 mg 是历史标签中每片的标示量，不是个人每天该用多少片，也不能据此把另一品牌、另一剂型或另一市场产品自行换算。", "en": "Check PLENDIL, felodipine, extended-release tablet, actual strength, NDC and target market together. The 2.5, 5 and 10 mg figures are historical labelled amounts per tablet, not how many tablets anyone should use, and they cannot self-convert another brand, form or market product." }, { "zh": "该历史标签写明缓释片应整片吞服，不应压碎或咀嚼。它不代替实际药盒的现行说明书；若问题是能否掰开、吞咽困难、漏用、调整或更换，应带现行药盒、处方和完整药单请药师或开方团队核对。", "en": "The historical label says the extended-release tablets should be swallowed whole and not crushed or chewed. It does not replace the current leaflet for an actual pack; for splitting, swallowing difficulty, missed use, adjustment or switching, take the current pack, prescription and complete medicine list to a pharmacist or prescribing team." }, { "zh": "历史标签列出 CYP3A4 相关药物和葡萄柚等需核对线索，也提示高龄、多药或肝功能情况需要更谨慎地审阅。它不是自行停、加、错开或替换任何药物的清单；请让专业人员结合准确产品和完整药单核对。", "en": "The historical label lists CYP3A4-related medicines and grapefruit as review cues and notes the need for more careful review with older age, multiple medicines or hepatic context. It is not a list for self-stopping, adding, spacing or replacing any medicine; have a professional review the exact product and complete medicine list." } ], "source": { "id": "src_6125ca4152d0b775", "label": "FDA：PLENDIL（felodipine）美国历史标签（2012-10 修订；Dosage and Administration / Drug Interactions）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019834s025lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "非洛地平怎样起作用：历史标签将其列为二氢吡啶类钙通道阻滞剂", "en": "How felodipine works: the historical label identifies a dihydropyridine calcium-channel blocker" }, "summary": { "zh": "FDA 2012 年历史标签将非洛地平描述为二氢吡啶类钙通道阻滞剂，主要作用于血管平滑肌的电压依赖性钙通道。该机制帮助理解标签用语，不用于判断任何人的诊断、是否适用、效果、片数、联用或换药。", "en": "The FDA 2012 historical label describes felodipine as a dihydropyridine calcium-channel blocker acting mainly at voltage-dependent calcium channels in vascular smooth muscle. This helps explain label wording; it does not determine anyone's diagnosis, suitability, effect, tablet count, co-use or switching." }, "checks": [ { "zh": "“钙通道阻滞剂”是作用路径类别，不表示所有同类药、同一通用名或相近降压药都能自行替换、叠加或按 mg 对等换算。", "en": "“Calcium-channel blocker” is a mechanism class, not evidence that all related medicines, the same generic name or similar blood-pressure medicines can be self-replaced, combined or milligram-converted." }, { "zh": "“主要作用于血管平滑肌”也不说明某个血压数字、头晕、胸闷或其他不适的具体原因，更不能据此决定是否继续、停用或更换。出现急性严重不适时优先使用当地紧急医疗渠道。", "en": "“Acts mainly in vascular smooth muscle” also does not explain the cause of a blood-pressure reading, dizziness, chest symptoms or another concern, and cannot decide continuation, stopping or switching. With an acute serious concern, prioritise local urgent medical care." }, { "zh": "历史机制资料不能替代实际药盒的现行说明书。若同时使用多种心血管药、非处方药或补充剂，应让药师或开方团队按准确产品、目标市场和完整药单逐项复核。", "en": "Historical mechanism material does not replace the current leaflet for an actual pack. If multiple cardiovascular medicines, OTC products or supplements are involved, have a pharmacist or prescribing team review the exact products, target market and complete medicine list item by item." } ], "source": { "id": "src_6125ca4152d0b775", "label": "FDA：PLENDIL（felodipine）美国历史标签（2012-10 修订；Clinical Pharmacology）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019834s025lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "Plendil", "generic": "非洛地平", "dosageFormClass": "缓释口服片：2.5 mg、5 mg、10 mg（FDA 2012 美国历史标签所列）" }, "labelSource": { "id": "src_6125ca4152d0b775", "label": "FDA：PLENDIL（felodipine）美国历史标签（2012-10 修订；页面明确可能不是最新获批标签）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019834s025lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "productRoutes": [ { "source": { "id": "src_6125ca4152d0b775", "label": "FDA：PLENDIL（felodipine）美国历史标签（2012-10 修订；页面明确可能不是最新获批标签）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019834s025lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "FDA 的 2012 年美国历史标签将 PLENDIL 列为非洛地平缓释口服片，并列出 2.5 mg、5 mg、10 mg 三种每片标示量。本页帮助读者把商品名、通用名、缓释片、历史 NDC、每片标签量和历史来源逐项对应；它不把毫克数字转成个人片数、掰开、开始、停用、联用、换药或购买建议。", "history": "FDA 历史标签标示 PLENDIL 为 AstraZeneca 的注册商标，修订日期为 2012-10，并提示文件可能不是最新获批标签。中国大陆政府公开药品价格记录曾将“波依定”与阿斯利康非洛地平缓释片对应；这一中文名称只作为检索和辨认线索，不证明当前批准、准确包装、库存、可售资格或与美国 PLENDIL 包装相同。不同强度、不同包装、不同市场或同通用名制剂都应按实际药盒与当地现行官方资料分别核对。", "sourceDocuments": [ { "id": "src_6125ca4152d0b775", "label": "FDA：PLENDIL（felodipine）美国历史标签（2012-10 修订；页面明确可能不是最新获批标签）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019834s025lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_98e45c6ee4b9de6a", "label": "江阴市人民政府：2022 年常用药品价格信息列示波依定／非洛地平缓释片（有日期名称线索）", "url": "https://www.jiangyin.gov.cn/doc/2022/08/24/1067954.shtml", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "government_price_record", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-31", "reviewedAt": "2026-08-31" } ], "applicationNumber": "NDA 019834", "approvalTimeline": [ { "date": "2012-10 historical label", "title": { "zh": "FDA 标签档案版本", "en": "FDA label archive version" }, "detail": { "zh": "本页链接 2012-10 historical label 的 FDA 标签档案作为可复核阅读入口。现行标签、规格、适应症和安全信息必须另行以目标市场当前文件核对。", "en": "This page links the 2012-10 historical label FDA label archive as a traceable reading entry point. Current labeling, strength, indication and safety information require separate verification against the target market’s current document." }, "source": { "id": "src_6125ca4152d0b775", "label": "FDA: PLENDIL historical U.S. label (revised 2012-10)", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019834s025lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "已链接公开标签档案", "en": "Public label archive linked" }, "detail": { "zh": "仅对应本页所列 FDA 文件。", "en": "Only the FDA document listed on this page is linked." } }, { "market": { "zh": "中国大陆、欧盟、日本", "en": "Mainland China, EU, Japan" }, "status": { "zh": "待逐项建立市场记录", "en": "Market record not established" }, "detail": { "zh": "不从美国标签档案推定当地批准、持有人、规格、供应或可售资格。", "en": "No local approval, holder, strength, supply or sale-eligibility conclusion is inferred from the U.S. label archive." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "标签档案能代表现在的产品信息吗？", "en": "Does a label archive represent current product information?" }, "answer": { "zh": "不能自动代表。档案用于定位来源；需要以目标市场的现行官方标签逐项复核。", "en": "Not automatically. The archive locates a source; each point needs verification against the target market’s current official label." } }, { "question": { "zh": "为什么这里不展示价格或原研/仿制结论？", "en": "Why are price and originator/generic conclusions not shown?" }, "answer": { "zh": "这些结论需要产品、剂型、规格、包装、市场、日期和原始记录分别齐全并经人工审核；单一标签文件不足以支持。", "en": "Those conclusions require separately complete and human-reviewed product, dosage-form, strength, pack, market, date and primary-record fields; one label file is insufficient." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "how-to-read-a-drug-label", "regulatory-sources-first" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/plendil/", "en": "https://origindrug.com/en/drugs/plendil/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "zetia", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-21", "status": "published_traceable_archive" }, "names": { "brand": "Zetia", "generic": "依折麦布", "aliases": [ "ezetimibe", "依折麦布" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "心血管", "sourceArchiveMarket": "美国 DailyMed 有日期公开标签（页面 2025-11-25 更新；本档案精确展示一个 10 mg、30 片瓶装面板）", "dosageFormClass": "依折麦布口服片：10 mg（DailyMed 页面 2025-11-25 更新；本档案精确展示 NDC 78206-178-01、30 片瓶装）", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "2002（FDA 标签所列美国初始批准）", "archiveSponsorText": "Organon LLC / DailyMed（NLM）公开标签档案" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [ "VYTORIN", "ezetimibe and simvastatin", "ezetimibe/simvastatin" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-zetia-ezetimibe-tablet-10mg-7820617801", "marketCode": "US", "labelVersion": { "zh": "DailyMed 页面 2025-11-25 更新的公开标签", "en": "public DailyMed label page updated 25 Nov 2025" }, "dosageForm": { "zh": "ZETIA 依折麦布口服片", "en": "ZETIA ezetimibe oral tablet" }, "route": { "zh": "口服（仅作标签产品身份字段）", "en": "oral (label product-identity field only)" }, "routeCodes": [ "oral" ], "productCode": "NDC 78206-178-01", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片 10 mg；30 片瓶装", "en": "10 mg per tablet; 30-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=174e45e0-45bb-48b7-9e60-8f6cfc1d22bb&name=zetia-02.jpg", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "依折麦布", "en": "ezetimibe" }, "value": 10, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人服用片数、加减、补服、换药或换算指令", "en": "labelled amount per tablet; not an individual tablet count, adjustment, make-up, switching or conversion instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "塑料瓶", "en": "plastic bottle" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-21", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 30, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "白色至类白色", "en": "white to off-white" }, "shape": { "zh": "胶囊形", "en": "capsule-shaped" }, "imprint": "414", "scoreStatus": "no_score", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_6528bbdf003c40bb", "label": "DailyMed（NLM）：ZETIA 依折麦布 10 mg、30 片瓶装美国公开标签面板（Organon；页面 2025-11-25 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=174e45e0-45bb-48b7-9e60-8f6cfc1d22bb", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-zetia-ezetimibe-tablet-10mg-7820617801", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=174e45e0-45bb-48b7-9e60-8f6cfc1d22bb&name=zetia-02.jpg", "alt": "ZETIA 依折麦布在美国 DailyMed Organon 公开标签中的 10 mg、NDC 78206-178-01、30 片瓶装展示面", "archiveMarket": "美国", "labelVersion": "DailyMed 页面 2025-11-25 更新", "presentation": "ZETIA 依折麦布口服片：每片 10 mg，NDC 78206-178-01，30 片瓶装展示面。", "notice": "此图只对应美国 DailyMed 当前标签中的 ZETIA、依折麦布 10 mg、NDC 78206-178-01 和 30 片瓶装。它仅帮助核对品牌、通用名、每片标示量、片剂、包装数量和来源；不用于鉴定真伪，也不证明 VYTORIN 等复方、其他包装、其他市场、当前可得性、原研身份、可替代性或任何个人的联用、开始、停用、换药或片数方案。", "source": { "id": "src_6528bbdf003c40bb", "label": "DailyMed（NLM）：ZETIA 依折麦布 10 mg、30 片瓶装美国公开标签面板（Organon；页面 2025-11-25 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=174e45e0-45bb-48b7-9e60-8f6cfc1d22bb", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "ZETIA 说明书放大阅读：同为降脂药，不代表可以自行与他汀叠加或换用", "en": "ZETIA label reading: being a lipid medicine does not permit self-adding to or switching with a statin" }, "summary": { "zh": "本模块以 FDA 2009 美国标签为阅读入口，帮助核对 ZETIA、依折麦布、口服片剂、标示强度和与其他降脂产品的阅读边界；它不提供个人联合、替换、剂量或治疗目标方案。", "en": "This module uses the 2009 U.S. FDA label as a reading entry point. It helps check ZETIA, ezetimibe, oral tablet, labelled strength and boundaries around other lipid medicines; it does not provide an individual combination, replacement, dose or treatment-target plan." }, "checks": [ { "zh": "先核对 ZETIA、依折麦布、口服片剂、每片标示强度和目标市场。它与阿托伐他汀、瑞舒伐他汀或其他降脂药名称出现在同一讨论中，不表示可以自行同日叠加、隔天轮换或从一盒直接换到另一盒。", "en": "Check ZETIA, ezetimibe, oral tablet, labelled strength per tablet and target market first. Appearing in the same discussion as atorvastatin, rosuvastatin or another lipid medicine does not permit self-adding on the same day, alternating or direct substitution from one pack to another." }, { "zh": "标签中与其他降脂药联用的内容依赖具体产品、适用情形、肝脏状况、既往反应和完整药单。网页不会把“同为降脂药”变成适合每个人的组合结论。", "en": "Label information about use with other lipid medicines depends on the exact product, context, liver status, prior reactions and complete medicine list. A webpage does not turn “both are lipid medicines” into a combination conclusion for everyone." }, { "zh": "mg 数字只是准确片剂的身份字段，不是血脂数值、风险或目标的个人算法。任何开始、停用、换药、掰片或联用问题应让医生或药师依据现行标签与实际情况核对。", "en": "The mg number is only an identity field for an exact tablet, not a personal algorithm for lipid results, risk or targets. Have a clinician or pharmacist review any start, stop, switch, splitting or combination question against the current label and real circumstances." }, { "zh": "出现肌肉不适、明显乏力、黄疸样变化或其他新症状时，不应自行判断是哪一种降脂药所致或同时停掉多种药；应带完整药单及时寻求专业评估。", "en": "With muscle symptoms, marked fatigue, jaundice-like changes or another new concern, do not self-attribute it to one lipid medicine or stop multiple medicines at once; seek timely professional assessment with the complete medicine list." } ], "source": { "id": "src_75219fbaef15cade", "label": "FDA：ZETIA 2009 美国处方信息（NDA 021445）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021445s025lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "依折麦布怎样起作用：它抑制小肠对胆固醇的吸收", "en": "How ezetimibe works: it inhibits intestinal cholesterol absorption" }, "summary": { "zh": "FDA 标签将依折麦布描述为抑制小肠对胆固醇吸收的药物。它说明与他汀类不同的一条作用路径，但不构成任何人应选哪一种、是否应联用、用多少或如何换药的结论。", "en": "The FDA label describes ezetimibe as inhibiting intestinal absorption of cholesterol. This explains a pathway distinct from statins, but does not determine which medicine anyone should choose, whether to combine, how much to use or how to switch." }, "checks": [ { "zh": "“作用路径不同”不等于可以自行把依折麦布与任何他汀、其他降脂药或保健品相加。适用情形、产品、肝脏情况、既往反应和完整药单必须由专业人员一并核对。", "en": "“A different pathway” does not make ezetimibe self-addable to any statin, lipid medicine or supplement. Context, product, liver status, prior reactions and the complete medicine list need professional review together." }, { "zh": "机制不能替代血脂化验、风险评估或确定个人治疗目标，也不能让药名相近或“降脂”标签变成自行换药依据。", "en": "Mechanism cannot replace lipid testing, risk assessment or an individual treatment target, nor make similar names or “lipid lowering” a basis for self-switching." }, { "zh": "肌肉、肝脏或其他新症状需要按完整药单与专业评估处理；不要从本页推断应同时停掉、改用或加入哪一种药。", "en": "Muscle, liver or other new symptoms need handling with the complete medicine list and professional assessment; do not infer which medicine to stop, change or add from this page." } ], "source": { "id": "src_75219fbaef15cade", "label": "FDA：ZETIA 2009 美国处方信息（临床药理）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021445s025lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "Zetia", "generic": "依折麦布", "dosageFormClass": "依折麦布口服片：10 mg（DailyMed 页面 2025-11-25 更新；本档案精确展示 NDC 78206-178-01、30 片瓶装）" }, "labelSource": { "id": "src_75219fbaef15cade", "label": "FDA：ZETIA 2009 美国标签档案（NDA 021445）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021445s025lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "productRoutes": [ { "source": { "id": "src_75219fbaef15cade", "label": "FDA：ZETIA 2009 美国标签档案（NDA 021445）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021445s025lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_6528bbdf003c40bb", "label": "DailyMed（NLM）：ZETIA 依折麦布公开标签（Organon；页面 2025-11-25 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=174e45e0-45bb-48b7-9e60-8f6cfc1d22bb", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "美国 DailyMed 的 ZETIA（ezetimibe）有日期公开标签列有 10 mg 口服片；本页建立一个准确包装面板的品牌、通用名、每片强度、NDC、外观线索和来源核对卡。它不把包装数字变成个人片数、加减、补服、停用、换药或联用方案，也不据此推定原研关系、目标市场批准、供应或销售资格。", "history": "DailyMed 页面列示 ZETIA 的 Initial U.S. Approval: 2002，当前公开标签列示 Organon LLC 为包装商。本页的包装面板只对应页面 2025-11-25 更新时所列的 ZETIA 单方依折麦布 10 mg、NDC 78206-178-01、30 片瓶装；VYTORIN（依折麦布/辛伐他汀）等复方产品不能按品牌或成分重叠并入本单方片剂档案。", "sourceDocuments": [ { "id": "src_75219fbaef15cade", "label": "FDA：ZETIA 2009 美国标签档案（NDA 021445）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021445s025lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_6528bbdf003c40bb", "label": "DailyMed（NLM）：ZETIA 依折麦布公开标签（Organon；页面 2025-11-25 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=174e45e0-45bb-48b7-9e60-8f6cfc1d22bb", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_5ed30b676fbb9773", "label": "FDA Drugs@FDA 官方检索入口", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_lookup_entry", "documentKind": "regulatory_lookup", "market": "US", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } ], "applicationNumber": "NDA 021445", "approvalTimeline": [ { "date": "2002", "title": { "zh": "FDA 标签所列美国初始批准年份", "en": "Initial U.S. approval year listed in the FDA label" }, "detail": { "zh": "本页链接的 FDA 标签档案列示 Initial U.S. Approval: 2002。该历史定位不等同于当前批准、可得性、持有人或其他市场状态。", "en": "The FDA label archive linked here lists Initial U.S. Approval: 2002. This historical locator is not a conclusion about current approval, availability, holder or another market." }, "source": { "id": "src_75219fbaef15cade", "label": "FDA: ZETIA label archive", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021445s025lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, { "date": "2009", "title": { "zh": "FDA 标签档案版本", "en": "FDA label archive version" }, "detail": { "zh": "本页链接 2009 的 FDA 标签档案作为可复核阅读入口。现行标签、规格、适应症和安全信息必须另行以目标市场当前文件核对。", "en": "This page links the 2009 FDA label archive as a traceable reading entry point. Current labeling, strength, indication and safety information require separate verification against the target market’s current document." }, "source": { "id": "src_75219fbaef15cade", "label": "FDA: ZETIA label archive", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021445s025lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "已链接公开标签档案", "en": "Public label archive linked" }, "detail": { "zh": "仅对应本页所列 FDA 文件。", "en": "Only the FDA document listed on this page is linked." } }, { "market": { "zh": "中国大陆、欧盟、日本", "en": "Mainland China, EU, Japan" }, "status": { "zh": "待逐项建立市场记录", "en": "Market record not established" }, "detail": { "zh": "不从美国标签档案推定当地批准、持有人、规格、供应或可售资格。", "en": "No local approval, holder, strength, supply or sale-eligibility conclusion is inferred from the U.S. label archive." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "标签档案能代表现在的产品信息吗？", "en": "Does a label archive represent current product information?" }, "answer": { "zh": "不能自动代表。档案用于定位来源；需要以目标市场的现行官方标签逐项复核。", "en": "Not automatically. The archive locates a source; each point needs verification against the target market’s current official label." } }, { "question": { "zh": "为什么这里不展示价格或原研/仿制结论？", "en": "Why are price and originator/generic conclusions not shown?" }, "answer": { "zh": "这些结论需要产品、剂型、规格、包装、市场、日期和原始记录分别齐全并经人工审核；单一标签文件不足以支持。", "en": "Those conclusions require separately complete and human-reviewed product, dosage-form, strength, pack, market, date and primary-record fields; one label file is insufficient." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "how-to-read-a-drug-label", "regulatory-sources-first" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/zetia/", "en": "https://origindrug.com/en/drugs/zetia/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "zocor", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-21", "status": "published_traceable_archive" }, "names": { "brand": "Zocor", "generic": "辛伐他汀", "aliases": [ "simvastatin", "辛伐他汀", "辛伐他汀片", "舒降之" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": { "value": "舒降之®", "status": "discovery_cue_requires_target_market_verification", "source": { "id": "src_ef150bc5f3a1f961", "label": "石家庄市人民政府：2026 年连锁药店价格信息中的舒降之／辛伐他汀片 20 mg 记录", "url": "https://www.sjz.gov.cn/columns/b250993e-f71f-4ba2-989e-18825c22f01a/202607/22/e0b20329-21d7-449a-ac68-1d287d2501c6.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "government_medicine_listing", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-12", "reviewedAt": "2026-09-12" } } }, "identity": { "therapeuticArea": "心血管", "sourceArchiveMarket": "美国 DailyMed 有日期公开标签（SPL v11，2025-03 更新/2025-04-03 发布；本档案分别展示三个准确包装面板）", "dosageFormClass": "辛伐他汀口服薄膜衣片：10 mg、20 mg、40 mg（DailyMed SPL v11 所列；分别展示三个 30 片瓶装面板）", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "1991（DailyMed 2025 美国公开标签所列初始批准）", "archiveSponsorText": "Organon LLC / DailyMed 公开监管标签档案" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [ "VYTORIN", "ezetimibe and simvastatin", "simvastatin and ezetimibe", "ezetimibe/simvastatin", "simvastatin/ezetimibe" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-zocor-simvastatin-tablet-10mg-7820618001", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v11，2025-03 更新；2025-04-03 发布", "en": "DailyMed SPL v11, updated Mar 2025 and published 3 Apr 2025" }, "dosageForm": { "zh": "ZOCOR 辛伐他汀口服薄膜衣片", "en": "ZOCOR simvastatin oral film-coated tablet" }, "route": { "zh": "口服（仅作标签产品身份字段）", "en": "oral (label product-identity field only)" }, "routeCodes": [ "oral" ], "productCode": "NDC 78206-180-01", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片 10 mg；30 片瓶装", "en": "10 mg per tablet; 30-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=8f55d5de-5a4f-4a39-8c84-c53976dd6af9&name=zocor-02.jpg", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "辛伐他汀", "en": "simvastatin" }, "value": 10, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人服用片数、加减、补服、换药或换算指令", "en": "labelled amount per tablet; not an individual tablet count, adjustment, make-up, switching or conversion instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "单位用量瓶装", "en": "unit-of-use bottle" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-21", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 30, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "桃色", "en": "peach" }, "shape": { "zh": "椭圆形", "en": "oval" }, "imprint": "MSD 735", "scoreStatus": "no_score", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_f3fc1892ba72b506", "label": "DailyMed（NLM）：ZOCOR 辛伐他汀 10 mg、30 片瓶装美国公开标签面板（Organon；SPL v11，2025-03 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8f55d5de-5a4f-4a39-8c84-c53976dd6af9", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-zocor-simvastatin-tablet-20mg-7820618101", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v11，2025-03 更新；2025-04-03 发布", "en": "DailyMed SPL v11, updated Mar 2025 and published 3 Apr 2025" }, "dosageForm": { "zh": "ZOCOR 辛伐他汀口服薄膜衣片", "en": "ZOCOR simvastatin oral film-coated tablet" }, "route": { "zh": "口服（仅作标签产品身份字段）", "en": "oral (label product-identity field only)" }, "routeCodes": [ "oral" ], "productCode": "NDC 78206-181-01", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片 20 mg；30 片瓶装", "en": "20 mg per tablet; 30-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=8f55d5de-5a4f-4a39-8c84-c53976dd6af9&name=zocor-03.jpg", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "辛伐他汀", "en": "simvastatin" }, "value": 20, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人服用片数、加减、补服、换药或换算指令", "en": "labelled amount per tablet; not an individual tablet count, adjustment, make-up, switching or conversion instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "单位用量瓶装", "en": "unit-of-use bottle" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-21", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 30, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "黄褐色", "en": "tan" }, "shape": { "zh": "椭圆形", "en": "oval" }, "imprint": "MSD 740", "scoreStatus": "no_score", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_f3fc1892ba72b506", "label": "DailyMed（NLM）：ZOCOR 辛伐他汀 20 mg、30 片瓶装美国公开标签面板（Organon；SPL v11，2025-03 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8f55d5de-5a4f-4a39-8c84-c53976dd6af9", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-zocor-simvastatin-tablet-40mg-7820618201", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v11，2025-03 更新；2025-04-03 发布", "en": "DailyMed SPL v11, updated Mar 2025 and published 3 Apr 2025" }, "dosageForm": { "zh": "ZOCOR 辛伐他汀口服薄膜衣片", "en": "ZOCOR simvastatin oral film-coated tablet" }, "route": { "zh": "口服（仅作标签产品身份字段）", "en": "oral (label product-identity field only)" }, "routeCodes": [ "oral" ], "productCode": "NDC 78206-182-01", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片 40 mg；30 片瓶装", "en": "40 mg per tablet; 30-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=8f55d5de-5a4f-4a39-8c84-c53976dd6af9&name=zocor-04.jpg", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "辛伐他汀", "en": "simvastatin" }, "value": 40, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人服用片数、加减、补服、换药或换算指令", "en": "labelled amount per tablet; not an individual tablet count, adjustment, make-up, switching or conversion instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "单位用量瓶装", "en": "unit-of-use bottle" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-21", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 30, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "砖红色", "en": "brick red" }, "shape": { "zh": "椭圆形", "en": "oval" }, "imprint": "MSD 749", "scoreStatus": "no_score", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_f3fc1892ba72b506", "label": "DailyMed（NLM）：ZOCOR 辛伐他汀 40 mg、30 片瓶装美国公开标签面板（Organon；SPL v11，2025-03 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8f55d5de-5a4f-4a39-8c84-c53976dd6af9", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-zocor-simvastatin-tablet-20mg-7820618101", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=zocor-03.jpg&setid=8f55d5de-5a4f-4a39-8c84-c53976dd6af9&type=img", "alt": "ZOCOR 辛伐他汀 20 mg 片剂在美国 DailyMed Organon 公开标签中的 30 片包装面板图", "archiveMarket": "美国", "labelVersion": "DailyMed SPL v11，2025-03 更新；2025-04-03 发布", "presentation": "ZOCOR（辛伐他汀）20 mg、NDC 78206-181-01、30 片瓶装包装面板图。", "notice": "此图只对应美国 DailyMed Organon 公开标签中的 ZOCOR、辛伐他汀 20 mg、NDC 78206-181-01 和 30 片瓶装。它仅帮助核对品牌、通用名、每片标示量、口服薄膜衣片、包装数量和来源；不用于鉴定真伪，也不证明 10 mg、40 mg、VYTORIN 等复方、其他包装、其他市场、当前可得性、原研身份、可替代性或任何个人的联用、开始、停用、换药或片数方案。", "source": { "id": "src_1437e7f2acb734a6", "label": "DailyMed（NLM）：ZOCOR 辛伐他汀公开标签（Organon，2025-03 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=8f55d5de-5a4f-4a39-8c84-c53976dd6af9", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "ZOCOR 说明书放大阅读：10、20、40 mg 是片剂身份，不是他汀换算表", "en": "ZOCOR label reading: 10, 20 and 40 mg identify tablets, not a statin conversion table" }, "summary": { "zh": "本模块以美国 DailyMed 2025-03 ZOCOR 公开标签为阅读入口，帮助核对 ZOCOR、辛伐他汀、10/20/40 mg 口服片、包装和标签中关于肌肉相关风险及相互作用的文字。它不决定个人片数、是否可在他汀之间转换、是否能联用或怎样停用。", "en": "This module uses the March 2025 U.S. DailyMed public label for ZOCOR as a reading entry point. It helps check ZOCOR, simvastatin, 10/20/40 mg oral tablets, the package, and label language about muscle-related risk and interactions. It does not decide an individual's tablet count, statin switch, combination or stopping plan." }, "checks": [ { "zh": "先把 ZOCOR、辛伐他汀、每片 10、20 或 40 mg、口服片、实际包装和目标市场一起核对。mg 是这一准确片剂的标示强度，不是“今天应吃几片”的网页答案，也不能据此把不同强度拼量或与另一种他汀互换。", "en": "Check ZOCOR, simvastatin, the stated 10, 20 or 40 mg per tablet, oral-tablet form, actual package and target market together. Mg identifies this exact tablet; it is not a web answer to “how many today,” and it does not permit self-combining strengths or interchanging another statin." }, { "zh": "标签对 80 mg 有专门限制文字。该信息不能被简化为自行加量、用剩药补量或由另一种他汀换算到 ZOCOR；任何强度变化都应由了解适应症、现行标签与完整药单的专业人员处理。", "en": "The label contains a specific restriction for 80 mg. It must not be simplified into self-escalation, using leftovers, or converting from another statin to ZOCOR; any strength change needs a professional who knows the indication, current label and complete medicine list." }, { "zh": "标签提示某些药物、葡萄柚汁及其他会影响药物暴露的情况需要核对。所有降脂药、抗感染药、心血管药、非处方药、草本和补充剂应连同实际包装交给药师或医生，不要因为产品名称不同就自行认定没有重复或相互作用。", "en": "The label signals that some medicines, grapefruit juice and other exposure-affecting situations need review. Bring every lipid medicine, anti-infective, cardiovascular medicine, OTC product, herb and supplement with the actual packages to a pharmacist or clinician; different names do not prove the absence of overlap or interactions." }, { "zh": "出现不明原因的肌肉疼痛、压痛或无力，尤其同时有发热、明显乏力或深色尿液等严重不适时，应及时使用当地医疗支持；不要仅凭网页自行停用、改用阿托伐他汀/瑞舒伐他汀或加用另一种降脂产品。", "en": "With unexplained muscle pain, tenderness or weakness—especially with fever, marked fatigue or dark urine or another severe symptom—use timely local medical support. Do not self-stop, change to atorvastatin/rosuvastatin, or add another lipid medicine from a webpage." } ], "source": { "id": "src_1437e7f2acb734a6", "label": "DailyMed（NLM）：ZOCOR 辛伐他汀公开标签（Organon，2025-03；标签阅读与警示）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=8f55d5de-5a4f-4a39-8c84-c53976dd6af9", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "辛伐他汀怎样起作用：它影响胆固醇合成路径中的 HMG-CoA 还原酶", "en": "How simvastatin works: it affects HMG-CoA reductase in the cholesterol-synthesis pathway" }, "summary": { "zh": "DailyMed 的 ZOCOR 标签将辛伐他汀描述为 HMG-CoA 还原酶抑制剂。该机制帮助理解它为何属于他汀类，但不预测个人血脂变化、肌肉反应、适用性、片数或与另一种他汀的组合。", "en": "The DailyMed ZOCOR label describes simvastatin as an HMG-CoA reductase inhibitor. This helps explain its statin class, but does not predict an individual's lipid response, muscle reaction, suitability, tablet count or combination with another statin." }, "checks": [ { "zh": "“同为 HMG-CoA 还原酶抑制剂”解释的是类别，不是阿托伐他汀、瑞舒伐他汀和辛伐他汀可以自行叠加、隔天轮换或按 mg 互相换算的证据。", "en": "“Both are HMG-CoA reductase inhibitors” explains a class; it is not evidence that atorvastatin, rosuvastatin and simvastatin can be self-combined, alternated or converted by mg." }, { "zh": "机制页面不能决定基因筛查、肌肉症状的原因、是否应换药或怎样处理相互作用。已有药物基因检测报告、完整药单、既往反应、肾肝情况与现行标签需要由专业人员一起解释。", "en": "A mechanism page cannot decide genetic screening, the cause of muscle symptoms, whether to switch, or how to manage interactions. Any pharmacogenomic report, complete medicine list, prior reactions, kidney/liver context and the current label need professional interpretation together." }, { "zh": "把机制读成“降脂通路”后，最安全的下一步仍是核对准确产品、强度、剂型、市场和全部用药，而不是据此自行增减、停用或再加一盒同类药。", "en": "After reading a mechanism as a “lipid pathway,” the safest next step is still to check the exact product, strength, dosage form, market and complete medicine list—not to self-adjust, stop or add another same-class pack." } ], "source": { "id": "src_1437e7f2acb734a6", "label": "DailyMed（NLM）：ZOCOR 辛伐他汀公开标签（Organon，2025-03；Clinical Pharmacology）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=8f55d5de-5a4f-4a39-8c84-c53976dd6af9", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "Zocor", "generic": "辛伐他汀", "dosageFormClass": "辛伐他汀口服薄膜衣片：10 mg、20 mg、40 mg（DailyMed SPL v11 所列；分别展示三个 30 片瓶装面板）" }, "labelSource": { "id": "src_1437e7f2acb734a6", "label": "DailyMed（NLM）：ZOCOR 辛伐他汀公开标签（Organon，2025-03 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=8f55d5de-5a4f-4a39-8c84-c53976dd6af9", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "productRoutes": [ { "source": { "id": "src_1437e7f2acb734a6", "label": "DailyMed（NLM）：ZOCOR 辛伐他汀公开标签（Organon，2025-03 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=8f55d5de-5a4f-4a39-8c84-c53976dd6af9", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [ { "id": "fda-2021-statin-pregnancy-breastfeeding-safety-communication", "issuedAt": "2021-07-20", "status": "fda_class_safety_communication", "title": { "zh": "FDA 药物安全通讯：他汀类药物在妊娠与哺乳期的标签变更", "en": "FDA Drug Safety Communication: labelling changes for statins in pregnancy and breastfeeding" }, "summary": { "zh": "FDA 于 2021-07-20 就整个他汀类发布安全通讯，明确列出 Lipitor（阿托伐他汀）和 Crestor（瑞舒伐他汀）。该通讯涉及美国处方信息中妊娠与哺乳相关警语的监管变更和个体化获益/风险判断；它不等于任何个人可以据此自行开始、停止、替换或调整药物。妊娠、疑似妊娠或哺乳相关问题应结合手中产品、目标市场现行说明书和开方团队意见核对。", "en": "On 2021-07-20, FDA issued a class Drug Safety Communication that explicitly lists Lipitor (atorvastatin) and Crestor (rosuvastatin). It concerns U.S. prescribing-information changes around pregnancy and breastfeeding and individualized benefit-risk review; it does not support self-starting, stopping, switching or adjusting any individual medicine. Pregnancy, suspected pregnancy or breastfeeding questions require the exact product, current target-market label and the prescribing team." }, "source": { "id": "src_e5fb970c597c7f50", "label": "FDA：2021-07-20 他汀类药物妊娠与哺乳期药物安全通讯", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/fda-requests-removal-strongest-warning-against-using-cholesterol-lowering-statins-during-pregnancy", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "DailyMed 的 ZOCOR（simvastatin）有日期美国公开标签列有 10 mg、20 mg、40 mg 口服薄膜衣片。本页分别建立三个准确包装面板的品牌、通用名、每片强度、NDC、外观线索和来源核对卡；不把包装数字变成个人片数、他汀之间的转换、联合用药、停用或购买结论。", "history": "本页三个包装面板严格对应美国 DailyMed 的 ZOCOR 10 mg、20 mg、40 mg、各 30 片瓶装；该标签同时明确 ZOCOR 的 5 mg 与 80 mg 强度已不再营销。本页不把任一面板扩展为其他包装、其他市场或当前库存证明；VYTORIN 等辛伐他汀/依折麦布复方，以及阿托伐他汀、瑞舒伐他汀等其他他汀产品，不能按名称或类别相近自行叠加、轮换或互换。", "sourceDocuments": [ { "id": "src_1437e7f2acb734a6", "label": "DailyMed（NLM）：ZOCOR 辛伐他汀公开标签（Organon，2025-03 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=8f55d5de-5a4f-4a39-8c84-c53976dd6af9", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_5ed30b676fbb9773", "label": "FDA Drugs@FDA 官方检索入口", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_lookup_entry", "documentKind": "regulatory_lookup", "market": "US", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } ], "applicationNumber": "NDA 019766", "approvalTimeline": [ { "date": "1991", "title": { "zh": "FDA 标签所列美国初始批准年份", "en": "Initial U.S. approval year listed in the FDA label" }, "detail": { "zh": "本页链接的 FDA 标签档案列示 Initial U.S. Approval: 1991。该历史定位不等同于当前批准、可得性、持有人或其他市场状态。", "en": "The FDA label archive linked here lists Initial U.S. Approval: 1991. This historical locator is not a conclusion about current approval, availability, holder or another market." }, "source": { "id": "src_1437e7f2acb734a6", "label": "DailyMed: ZOCOR public label archive", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=8f55d5de-5a4f-4a39-8c84-c53976dd6af9", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, { "date": "2025-03", "title": { "zh": "FDA 标签档案版本", "en": "FDA label archive version" }, "detail": { "zh": "本页链接 2025-03 的 FDA 标签档案作为可复核阅读入口。现行标签、规格、适应症和安全信息必须另行以目标市场当前文件核对。", "en": "This page links the 2025-03 FDA label archive as a traceable reading entry point. Current labeling, strength, indication and safety information require separate verification against the target market’s current document." }, "source": { "id": "src_1437e7f2acb734a6", "label": "DailyMed: ZOCOR public label archive", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=8f55d5de-5a4f-4a39-8c84-c53976dd6af9", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "已链接公开标签档案", "en": "Public label archive linked" }, "detail": { "zh": "仅对应本页所列 FDA 文件。", "en": "Only the FDA document listed on this page is linked." } }, { "market": { "zh": "中国大陆、欧盟、日本", "en": "Mainland China, EU, Japan" }, "status": { "zh": "待逐项建立市场记录", "en": "Market record not established" }, "detail": { "zh": "不从美国标签档案推定当地批准、持有人、规格、供应或可售资格。", "en": "No local approval, holder, strength, supply or sale-eligibility conclusion is inferred from the U.S. label archive." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "标签档案能代表现在的产品信息吗？", "en": "Does a label archive represent current product information?" }, "answer": { "zh": "不能自动代表。档案用于定位来源；需要以目标市场的现行官方标签逐项复核。", "en": "Not automatically. The archive locates a source; each point needs verification against the target market’s current official label." } }, { "question": { "zh": "为什么这里不展示价格或原研/仿制结论？", "en": "Why are price and originator/generic conclusions not shown?" }, "answer": { "zh": "这些结论需要产品、剂型、规格、包装、市场、日期和原始记录分别齐全并经人工审核；单一标签文件不足以支持。", "en": "Those conclusions require separately complete and human-reviewed product, dosage-form, strength, pack, market, date and primary-record fields; one label file is insufficient." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "how-to-read-a-drug-label", "regulatory-sources-first" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/zocor/", "en": "https://origindrug.com/en/drugs/zocor/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "livalo", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-25", "status": "published_traceable_archive" }, "names": { "brand": "LIVALO", "generic": "匹伐他汀", "aliases": [ "LIVALO", "pitavastatin", "pitavastatin calcium", "匹伐他汀" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "心血管", "sourceArchiveMarket": "美国：DailyMed 当前 LIVALO 公开标签（SPL v12，2026-03-31 生效；处方信息 2026-03 修订）列示匹伐他汀 1 mg、2 mg、4 mg 口服薄膜衣片及各自 90 片瓶装。该文件不建立中国大陆、欧盟、日本或其他市场的商品名、批准、供应、可售资格、原研/仿制关系或可替代性。", "dosageFormClass": "匹伐他汀口服薄膜衣片：1 mg、2 mg、4 mg（美国当前公开标签所列；各 90 片瓶装）", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "2009（当前美国公开标签所列 Initial U.S. Approval）", "archiveSponsorText": "Kowa Pharmaceuticals America, Inc.（所引美国公开标签所列经销方）" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [ "ZYPITAMAG", "pitavastatin magnesium", "pitavastatin oral solution", "匹伐他汀口服溶液" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-livalo-pitavastatin-tablet-1mg-90-bottle-ndc-6686910490", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（SPL v12；2026-03-31 生效；处方信息 2026-03 修订）", "en": "Current U.S. DailyMed public label (SPL v12; effective 31 Mar 2026; prescribing information revised Mar 2026)" }, "dosageForm": { "zh": "LIVALO 匹伐他汀口服薄膜衣片", "en": "LIVALO pitavastatin film-coated oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 66869-104-90", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片匹伐他汀 1 mg；90 片瓶装", "en": "Pitavastatin 1 mg per tablet; 90-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=livalo-03.jpg&id=956917", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "匹伐他汀", "en": "pitavastatin" }, "value": 1, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、联用、换药或调整规则", "en": "labelled amount per tablet; not an individual's tablet count, combination, switch or adjustment rule" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 90, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-25", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 90, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "白色", "en": "white" }, "shape": { "zh": "圆形薄膜衣片，约 6 mm；无刻痕，不是自行掰开指示", "en": "round film-coated tablet, about 6 mm; unscored, not a self-splitting instruction" }, "imprint": "KC / 1", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_4e3657a1e460a03d", "label": "DailyMed（NLM）：LIVALO 匹伐他汀当前美国公开标签（Kowa；SPL v12，2026-03-31 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=44dcbf97-99ec-427c-ba50-207e0069d6d2", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-25", "reviewedAt": "2026-08-25" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-livalo-pitavastatin-tablet-2mg-90-bottle-ndc-6686920490", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（SPL v12；2026-03-31 生效；处方信息 2026-03 修订）", "en": "Current U.S. DailyMed public label (SPL v12; effective 31 Mar 2026; prescribing information revised Mar 2026)" }, "dosageForm": { "zh": "LIVALO 匹伐他汀口服薄膜衣片", "en": "LIVALO pitavastatin film-coated oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 66869-204-90", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片匹伐他汀 2 mg；90 片瓶装", "en": "Pitavastatin 2 mg per tablet; 90-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=livalo-04.jpg&id=956917", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "匹伐他汀", "en": "pitavastatin" }, "value": 2, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、联用、换药或调整规则", "en": "labelled amount per tablet; not an individual's tablet count, combination, switch or adjustment rule" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 90, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-25", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 90, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "白色", "en": "white" }, "shape": { "zh": "圆形薄膜衣片，约 8 mm；无刻痕，不是自行掰开指示", "en": "round film-coated tablet, about 8 mm; unscored, not a self-splitting instruction" }, "imprint": "KC / 2", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_4e3657a1e460a03d", "label": "DailyMed（NLM）：LIVALO 匹伐他汀当前美国公开标签（Kowa；SPL v12，2026-03-31 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=44dcbf97-99ec-427c-ba50-207e0069d6d2", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-25", "reviewedAt": "2026-08-25" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-livalo-pitavastatin-tablet-4mg-90-bottle-ndc-6686940490", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（SPL v12；2026-03-31 生效；处方信息 2026-03 修订）", "en": "Current U.S. DailyMed public label (SPL v12; effective 31 Mar 2026; prescribing information revised Mar 2026)" }, "dosageForm": { "zh": "LIVALO 匹伐他汀口服薄膜衣片", "en": "LIVALO pitavastatin film-coated oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 66869-404-90", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片匹伐他汀 4 mg；90 片瓶装", "en": "Pitavastatin 4 mg per tablet; 90-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=livalo-05.jpg&id=956917", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "匹伐他汀", "en": "pitavastatin" }, "value": 4, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、联用、换药或调整规则", "en": "labelled amount per tablet; not an individual's tablet count, combination, switch or adjustment rule" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 90, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-25", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 90, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "白色", "en": "white" }, "shape": { "zh": "圆形薄膜衣片，约 10 mm；无刻痕，不是自行掰开指示", "en": "round film-coated tablet, about 10 mm; unscored, not a self-splitting instruction" }, "imprint": "KC / 4", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_4e3657a1e460a03d", "label": "DailyMed（NLM）：LIVALO 匹伐他汀当前美国公开标签（Kowa；SPL v12，2026-03-31 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=44dcbf97-99ec-427c-ba50-207e0069d6d2", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-25", "reviewedAt": "2026-08-25" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-livalo-pitavastatin-tablet-1mg-90-bottle-ndc-6686910490", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=livalo-03.jpg&id=956917", "alt": "LIVALO 匹伐他汀 1 mg、NDC 66869-104-90、90 片瓶装在美国 DailyMed 当前公开标签中的包装图", "archiveMarket": "美国", "labelVersion": "DailyMed SPL v12（2026-03-31 生效；处方信息 2026-03 修订）", "presentation": "LIVALO 匹伐他汀：每片 1 mg，NDC 66869-104-90，90 片瓶装（美国当前公开标签）。", "notice": "此图只对应美国 DailyMed 当前公开标签中的 LIVALO、匹伐他汀 1 mg、NDC 66869-104-90 与 90 片瓶装。它只帮助核对品牌、通用名、每片标示量、包装与来源；不用于鉴定真伪，也不代表 2/4 mg、其他包装、ZYPITAMAG、其他匹伐他汀、其他他汀、其他市场、当前可得性、原研身份、可替代性或任何个人的片数、联用、换药或停药方案。", "source": { "id": "src_4e3657a1e460a03d", "label": "DailyMed（NLM）：LIVALO 匹伐他汀 1 mg、90 片瓶装当前美国公开标签面板（Kowa；SPL v12）", "url": "https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=44dcbf97-99ec-427c-ba50-207e0069d6d2", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-25", "reviewedAt": "2026-08-25" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "LIVALO／匹伐他汀说明书放大阅读：先认清 1／2／4 mg、NDC 与 90 片瓶装", "en": "LIVALO label reading: identify 1/2/4 mg, NDC and the 90-tablet bottle first" }, "summary": { "zh": "本模块只阅读美国 DailyMed 当前标签中的 LIVALO、匹伐他汀、每片 1/2/4 mg、准确 NDC、90 片瓶装、外形与警示。它不提供个人片数、用药时间、同服、停用、换药、分片或购买方案。", "en": "This module reads only LIVALO, pitavastatin, 1/2/4 mg per tablet, exact NDCs, 90-tablet bottles, appearance and warnings in the current U.S. DailyMed label. It provides no individual tablet count, timing, co-use, stopping, switching, splitting or purchase plan." }, "checks": [ { "zh": "先同时核对 LIVALO、匹伐他汀、1/2/4 mg、实际 NDC、90 片瓶装、白色圆形片、KC 压印与目标市场。mg 是这个准确片剂每片的标示量，不是网页可计算的个人片数、其他他汀换算或同类药叠加规则。", "en": "Check LIVALO, pitavastatin, 1/2/4 mg, the actual NDC, 90-tablet bottle, white round tablet, KC imprint and target market together. mg is the labelled amount in that exact tablet, not a web calculation for tablet count, conversion to another statin or combining same-class medicines." }, { "zh": "当前标签将三种片剂描述为无刻痕；颜色、大小、圆形和压印只用于辅助核对，不能鉴定真伪，也不是自行掰开、减量或由一种强度替换另一种的指令。", "en": "The current label describes all three tablets as unscored. Colour, size, round shape and imprint are supporting checks only; they cannot authenticate a product and are not instructions to self-split, reduce use or replace one strength with another." }, { "zh": "标签将年龄较大、肾功能问题、未控制甲状腺功能减退、某些联用药和其他降脂治疗列为需要专业核对的情形，并列有肌肉相关风险与环孢素禁忌。请把全部处方药、非处方药、补充剂与实际药盒交给药师或开方团队逐项核对；网页不能把这些条目变成个人的“能否同服”结论。", "en": "The label identifies older age, kidney concerns, uncontrolled hypothyroidism, certain co-medications and other lipid-lowering therapy as matters for professional review, and includes muscle-related risk and a cyclosporine contraindication. Give every prescription medicine, OTC product, supplement and actual pack to a pharmacist or prescriber for item-by-item review; this page cannot turn these items into an individual co-use decision." }, { "zh": "新发或明显的肌肉疼痛、压痛、无力，尤其伴随不适或发热，或出现黄疸样变化、深色尿、严重过敏样反应、呼吸困难或其他急性严重不适时，应优先使用当地医疗支持；不要通过同时停换多种药来试探原因。", "en": "With new or marked muscle pain, tenderness or weakness, especially with malaise or fever, or jaundice-like changes, dark urine, a serious allergy-like reaction, breathing difficulty or another acute serious concern, prioritise local medical support; do not test the cause by stopping and changing several medicines at once." } ], "source": { "id": "src_4e3657a1e460a03d", "label": "DailyMed（NLM）：LIVALO 匹伐他汀当前美国公开标签（Warnings, Contraindications and Patient Counseling；Kowa；SPL v12）", "url": "https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=44dcbf97-99ec-427c-ba50-207e0069d6d2", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-25", "reviewedAt": "2026-08-25" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "匹伐他汀怎样在标签中被描述：HMG-CoA 还原酶抑制路径，不是自行选药规则", "en": "How pitavastatin is described in the label: an HMG-CoA-reductase inhibition pathway, not a self-selection rule" }, "summary": { "zh": "当前美国标签将匹伐他汀描述为 HMG-CoA 还原酶抑制剂。该机制帮助理解“他汀”这一药物类别；它不能判断个人为何适合或不适合某一他汀、是否需要基因检测、能否同服、如何换药或应服几片。", "en": "The current U.S. label describes pitavastatin as an HMG-CoA reductase inhibitor. This helps explain the statin drug class; it cannot decide why an individual does or does not fit a statin, whether genetic testing is needed, whether medicines can be combined, how to switch or how many tablets to use." }, "checks": [ { "zh": "LIVALO、立普妥、可定、舒降之等产品即使都可被归入他汀相关范围，也不因此建立个人可自行交替、叠加、等量换算或依药名选药的关系。", "en": "Even where LIVALO, Lipitor, Crestor and Zocor can all be described in a statin-related context, that does not establish self-directed alternation, combining, equal conversion or name-based selection for an individual." }, { "zh": "机制页面不把任何人的肌肉症状、化验结果、肾肝功能、年龄、合并疾病或完整药单简化为“该选哪一种他汀”的答案；已有药物基因检测报告也须由专业人员结合这些资料解释。", "en": "A mechanism page does not reduce an individual's muscle symptoms, test results, kidney/liver function, age, coexisting conditions or complete medicine list to an answer about which statin to choose; an existing pharmacogenomic report also needs professional interpretation with those materials." }, { "zh": "不要把机制、包装图或一个 mg 数字用于处理急性症状、补用、停用、换药或联用。现实问题必须回到准确产品的现行目标市场标签和药师或医生。", "en": "Do not use mechanism, a package image or one mg number to handle an acute symptom, make-up use, stopping, switching or co-use. Real questions must return to the current target-market label for the exact product and a pharmacist or clinician." } ], "source": { "id": "src_4e3657a1e460a03d", "label": "DailyMed（NLM）：LIVALO 匹伐他汀当前美国公开标签（Clinical Pharmacology；Kowa；SPL v12）", "url": "https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=44dcbf97-99ec-427c-ba50-207e0069d6d2", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-25", "reviewedAt": "2026-08-25" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "LIVALO", "generic": "匹伐他汀", "dosageFormClass": "匹伐他汀口服薄膜衣片：1 mg、2 mg、4 mg（美国当前公开标签所列；各 90 片瓶装）" }, "labelSource": { "id": "src_4e3657a1e460a03d", "label": "DailyMed（NLM）：LIVALO 匹伐他汀当前美国公开标签（Kowa；SPL v12，2026-03-31 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=44dcbf97-99ec-427c-ba50-207e0069d6d2", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-25", "reviewedAt": "2026-08-25" }, "productRoutes": [ { "source": { "id": "src_4e3657a1e460a03d", "label": "DailyMed（NLM）：LIVALO 匹伐他汀当前美国公开标签（Kowa；SPL v12，2026-03-31 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=44dcbf97-99ec-427c-ba50-207e0069d6d2", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-25", "reviewedAt": "2026-08-25" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-25", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-25", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "DailyMed 的当前 LIVALO（pitavastatin）美国公开标签列示 1 mg、2 mg、4 mg 口服薄膜衣片、各自 90 片瓶装、NDC、白色圆形外观和 KC 压印。本页帮助读者把商品名、通用名、每片标示量、准确包装、公开电子说明书与药物警戒阅读路径放在一起；不把 mg、包装数量或“同属他汀”转换为个人片数、同服、轮换、停用、换药或购买结论。", "history": "当前标签列示 Initial U.S. Approval: 2009，SPL v12 的生效日期为 2026-03-31。1/2/4 mg、各自 NDC 与 90 片瓶装是不同的产品身份字段；同为他汀、相近毫克数或相同白色圆片外观，均不能建立与阿托伐他汀、瑞舒伐他汀、辛伐他汀或其他匹伐他汀产品的自行互换、合用或换算关系。", "sourceDocuments": [ { "id": "src_4e3657a1e460a03d", "label": "DailyMed（NLM）：LIVALO 匹伐他汀当前美国公开标签（Kowa；SPL v12，2026-03-31 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=44dcbf97-99ec-427c-ba50-207e0069d6d2", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-25", "reviewedAt": "2026-08-25" }, { "id": "src_5ed30b676fbb9773", "label": "FDA Drugs@FDA 官方检索入口（LIVALO；NDA 022363）", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_lookup_entry", "documentKind": "regulatory_lookup", "market": "US", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } ], "applicationNumber": "NDA 022363", "approvalTimeline": [ { "date": "2009", "title": { "zh": "当前标签所列美国初始批准年份", "en": "Initial U.S. approval year listed in the current label" }, "detail": { "zh": "当前 LIVALO 美国公开标签列示 Initial U.S. Approval: 2009。该年份只定位所引美国标签历史，不建立中国大陆、欧盟、日本或其他市场的批准、供应、可售资格、原研/仿制关系或个人适用性。", "en": "The current U.S. LIVALO public label lists Initial U.S. Approval: 2009. This only locates the cited U.S. label history; it does not establish approval, supply, sale eligibility, originator/generic relationship or individual suitability in Mainland China, the EU, Japan or another market." }, "source": { "id": "src_4e3657a1e460a03d", "label": "DailyMed（NLM）：LIVALO 匹伐他汀当前美国公开标签（Kowa；SPL v12）", "url": "https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=44dcbf97-99ec-427c-ba50-207e0069d6d2", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-25", "reviewedAt": "2026-08-25" } }, { "date": "2026-03-31", "title": { "zh": "当前 SPL v12 生效日期", "en": "Current SPL v12 effective date" }, "detail": { "zh": "DailyMed 当前 LIVALO 公开标签的 Effective Time 为 2026-03-31，处方信息修订为 2026-03。本页只分别展示 1 mg、2 mg、4 mg 的 90 片瓶装面板；不建立实际在售、库存、购买、个人片数、联用、停用、换药或其他市场状态。", "en": "The current DailyMed LIVALO public label has an effective time of 31 Mar 2026 and prescribing information revised in Mar 2026. This page separately displays the 1 mg, 2 mg and 4 mg 90-tablet bottle panels; it does not establish actual availability, stock, purchase, individual tablet count, co-use, stopping, switching or another-market status." }, "source": { "id": "src_4e3657a1e460a03d", "label": "DailyMed（NLM）：LIVALO 匹伐他汀当前美国公开标签（Kowa；SPL v12，2026-03-31 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=44dcbf97-99ec-427c-ba50-207e0069d6d2", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-25", "reviewedAt": "2026-08-25" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "已链接当前公开标签与三组准确 90 片瓶装面板", "en": "Current public label and three exact 90-tablet bottle panels linked" }, "detail": { "zh": "本页分别展示 LIVALO 匹伐他汀 1 mg、NDC 66869-104-90；2 mg、NDC 66869-204-90；4 mg、NDC 66869-404-90 的 90 片瓶装。它不用于鉴定真伪，也不建立实际在售、库存、购买、个人片数、开始、停用、联用、换药或可替代性。", "en": "This page separately displays LIVALO pitavastatin 1 mg/NDC 66869-104-90, 2 mg/NDC 66869-204-90 and 4 mg/NDC 66869-404-90 90-tablet bottles. It does not authenticate a product or establish actual availability, stock, purchase, individual tablet count, initiation, stopping, co-use, switching or interchangeability." } }, { "market": { "zh": "中国大陆、欧盟、日本及其他市场", "en": "Mainland China, EU, Japan and other markets" }, "status": { "zh": "待逐项建立市场记录", "en": "Market record not established" }, "detail": { "zh": "不从美国标签、NDA、NDC、英文品牌、包装图或标签主体推定当地商品名、批准、包装、供应、可售资格、原研/仿制关系或可替代性；每个市场均须按当地现行监管资料单独核对。", "en": "No local trade name, approval, packaging, supply, sale eligibility, originator/generic relationship or interchangeability is inferred from the U.S. label, NDA, NDC, English brand, package image or label entity; every market requires separate checking against current local regulatory material." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "1、2、4 mg 与 90 片瓶装能不能用来自己决定片数、换到另一种他汀或与另一种他汀同服？", "en": "Can 1, 2, 4 mg and a 90-tablet bottle be used to decide my own tablet count, change to another statin or use it with another statin?" }, "answer": { "zh": "不能。这些字段只识别所引美国标签中的准确 LIVALO 片剂和包装。共同药物类别、相近毫克数、包装照片或同为降脂相关产品，均不建立自行开始、增加、补用、停用、联用、轮换或替代关系；请带现行药盒、处方和完整药单请药师或开方团队复核。", "en": "No. These fields only identify the exact LIVALO tablets and packages in the cited U.S. label. A shared drug class, a nearby milligram number, a package photo or a related lipid-lowering context does not establish self-initiation, increase, make-up use, stopping, co-use, alternation or substitution; take the current pack, prescription and complete medicine list to a pharmacist or prescribing team for review." } }, { "question": { "zh": "为什么页面提到年龄、肾脏、甲状腺和联用药，却不告诉我自己应选哪一种他汀？", "en": "Why does the page mention age, kidney issues, thyroid status and co-medications without telling me which statin to choose?" }, "answer": { "zh": "这些是当前标签中需要专业核对的风险与相互作用阅读线索，不是个体化选药或治疗决策。药师或医生需要把准确产品、病史、检查结果、既往反应与完整药单一起审查；出现急性严重不适时，应使用当地医疗支持。", "en": "These are label-based risk and interaction reading cues requiring professional review, not personalised drug selection or treatment decisions. A pharmacist or clinician needs the exact product, history, test results, prior reactions and complete medicine list together; for an acute serious concern, use local medical support." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "dosage-forms-are-part-of-medicine-identity", "how-to-read-a-drug-label" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/livalo/", "en": "https://origindrug.com/en/drugs/livalo/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "vascepa", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-25", "status": "published_traceable_archive" }, "names": { "brand": "VASCEPA", "generic": "二十碳五烯酸乙酯", "aliases": [ "VASCEPA", "icosapent ethyl", "二十碳五烯酸乙酯", "EPA ethyl ester" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "心血管", "sourceArchiveMarket": "美国：DailyMed 当前 VASCEPA 公开标签（SPL v21，2026-03-23 更新）列示二十碳五烯酸乙酯 0.5 g／1 g 口服胶囊及所展示的准确 NDC 瓶装面板。该文件不建立中国大陆、欧盟、日本或其他市场的商品名、批准、供应、可售资格、原研/仿制关系、鱼油/补充剂等同关系或可替代性。", "dosageFormClass": "二十碳五烯酸乙酯口服胶囊：每粒 500 mg 或 1000 mg（美国当前公开标签所列；展示三个准确 NDC 瓶装）", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "2012（当前美国公开标签所列 Initial U.S. Approval）", "archiveSponsorText": "Amarin Pharma Inc.（所引美国公开标签所列标签方）" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [ "fish oil dietary supplement", "鱼油补充剂", "other omega-3 product", "其他 omega-3 产品", "non-VASCEPA icosapent ethyl package", "非 VASCEPA 的二十碳五烯酸乙酯包装" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-vascepa-icosapent-ethyl-capsule-500mg-240-bottle-ndc-5293700340", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（SPL v21；2026-03-23 更新）", "en": "Current U.S. DailyMed public label (SPL v21; updated 23 Mar 2026)" }, "dosageForm": { "zh": "VASCEPA 二十碳五烯酸乙酯口服胶囊", "en": "VASCEPA icosapent ethyl oral capsule" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 52937-003-40", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_capsule", "primaryDisplay": { "zh": "每粒二十碳五烯酸乙酯 500 mg；240 粒瓶装", "en": "Icosapent ethyl 500 mg per capsule; 240-capsule bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=vascepa-03.jpg&setid=9c1a2828-1583-4414-ab22-a60480e8e508", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "二十碳五烯酸乙酯", "en": "icosapent ethyl" }, "value": 500, "unit": "mg", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒标签标示量；不是个人胶囊数、联用、换药或调整规则", "en": "labelled amount per capsule; not an individual's capsule count, combination, switch or adjustment rule" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 240, "countUnit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-25", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 240, "unit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "physicalClues": { "color": { "zh": "琥珀黄色", "en": "amber" }, "shape": { "zh": "椭圆形胶囊，约 15 mm；无刻痕，不是自行打开或分用指示", "en": "oval capsule, about 15 mm; unscored, not a self-opening or splitting instruction" }, "imprint": "V500", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_e3f016d82eabae04", "label": "DailyMed（NLM）：VASCEPA 二十碳五烯酸乙酯当前美国公开标签（Amarin Pharma；SPL v21，2026-03-23 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=9c1a2828-1583-4414-ab22-a60480e8e508&version=21", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-25", "reviewedAt": "2026-08-25" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-vascepa-icosapent-ethyl-capsule-1000mg-120-bottle-ndc-5293700120", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（SPL v21；2026-03-23 更新）", "en": "Current U.S. DailyMed public label (SPL v21; updated 23 Mar 2026)" }, "dosageForm": { "zh": "VASCEPA 二十碳五烯酸乙酯口服胶囊", "en": "VASCEPA icosapent ethyl oral capsule" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 52937-001-20", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_capsule", "primaryDisplay": { "zh": "每粒二十碳五烯酸乙酯 1000 mg；120 粒瓶装", "en": "Icosapent ethyl 1000 mg per capsule; 120-capsule bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=vascepa-04.jpg&setid=9c1a2828-1583-4414-ab22-a60480e8e508", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "二十碳五烯酸乙酯", "en": "icosapent ethyl" }, "value": 1000, "unit": "mg", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒标签标示量；不是个人胶囊数、联用、换药或调整规则", "en": "labelled amount per capsule; not an individual's capsule count, combination, switch or adjustment rule" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 120, "countUnit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-25", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 120, "unit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "physicalClues": { "color": { "zh": "琥珀黄色", "en": "amber" }, "shape": { "zh": "长椭圆形胶囊，约 25 mm；无刻痕，不是自行打开或分用指示", "en": "oblong capsule, about 25 mm; unscored, not a self-opening or splitting instruction" }, "imprint": "VASCEPA", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_e3f016d82eabae04", "label": "DailyMed（NLM）：VASCEPA 二十碳五烯酸乙酯当前美国公开标签（Amarin Pharma；SPL v21，2026-03-23 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=9c1a2828-1583-4414-ab22-a60480e8e508&version=21", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-25", "reviewedAt": "2026-08-25" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-vascepa-icosapent-ethyl-capsule-1000mg-120-bottle-ndc-5293700520", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（SPL v21；2026-03-23 更新）", "en": "Current U.S. DailyMed public label (SPL v21; updated 23 Mar 2026)" }, "dosageForm": { "zh": "VASCEPA 二十碳五烯酸乙酯口服胶囊", "en": "VASCEPA icosapent ethyl oral capsule" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 52937-005-20", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_capsule", "primaryDisplay": { "zh": "每粒二十碳五烯酸乙酯 1000 mg；120 粒瓶装", "en": "Icosapent ethyl 1000 mg per capsule; 120-capsule bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=vascepa-06.jpg&setid=9c1a2828-1583-4414-ab22-a60480e8e508", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "二十碳五烯酸乙酯", "en": "icosapent ethyl" }, "value": 1000, "unit": "mg", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒标签标示量；不是个人胶囊数、联用、换药或调整规则", "en": "labelled amount per capsule; not an individual's capsule count, combination, switch or adjustment rule" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 120, "countUnit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-25", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 120, "unit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "physicalClues": { "color": { "zh": "琥珀黄色", "en": "amber" }, "shape": { "zh": "椭圆形胶囊，约 25 mm；无刻痕，不是自行打开或分用指示", "en": "oval capsule, about 25 mm; unscored, not a self-opening or splitting instruction" }, "imprint": "IPE", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_e3f016d82eabae04", "label": "DailyMed（NLM）：VASCEPA 二十碳五烯酸乙酯当前美国公开标签（Amarin Pharma；SPL v21，2026-03-23 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=9c1a2828-1583-4414-ab22-a60480e8e508&version=21", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-25", "reviewedAt": "2026-08-25" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-vascepa-icosapent-ethyl-capsule-1000mg-120-bottle-ndc-5293700120", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=vascepa-04.jpg&setid=9c1a2828-1583-4414-ab22-a60480e8e508", "alt": "VASCEPA 二十碳五烯酸乙酯 1 g、NDC 52937-001-20、120 粒瓶装在美国 DailyMed 当前公开标签中的包装图", "archiveMarket": "美国", "labelVersion": "DailyMed SPL v21（2026-03-23 更新）", "presentation": "VASCEPA 二十碳五烯酸乙酯：每粒 1000 mg，NDC 52937-001-20，120 粒瓶装（美国当前公开标签）。", "notice": "此图只对应美国 DailyMed 当前公开标签中的 VASCEPA、二十碳五烯酸乙酯 1 g、NDC 52937-001-20 与 120 粒瓶装。它只帮助核对品牌、通用名、每粒标示量、包装、外观和来源；不用于鉴定真伪，也不代表 0.5 g、NDC 52937-005-20、其他包装、普通鱼油、其他 omega-3 产品、其他二十碳五烯酸乙酯、其他市场、当前可得性、原研身份、相等性、可替代性或任何个人的胶囊数、联用、换药或停药方案。", "source": { "id": "src_e3f016d82eabae04", "label": "DailyMed（NLM）：VASCEPA 二十碳五烯酸乙酯 1 g、120 粒瓶装当前美国公开标签面板（Amarin Pharma；SPL v21）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=9c1a2828-1583-4414-ab22-a60480e8e508&version=21", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-25", "reviewedAt": "2026-08-25" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "VASCEPA／二十碳五烯酸乙酯说明书放大阅读：先认清 0.5／1 g、NDC 与瓶装", "en": "VASCEPA label reading: identify 0.5/1 g, NDC and the bottle first" }, "summary": { "zh": "本模块只阅读美国 DailyMed 当前标签中的 VASCEPA、二十碳五烯酸乙酯、每粒 0.5 g／1 g、准确 NDC、瓶装、外形与警示。它不提供个人胶囊数、用药时间、同服、停用、换药、打开胶囊、分用或购买方案。", "en": "This module reads only VASCEPA, icosapent ethyl, 0.5/1 g per capsule, exact NDCs, bottles, appearance and warnings in the current U.S. DailyMed label. It provides no individual capsule count, timing, co-use, stopping, switching, opening, splitting or purchase plan." }, "checks": [ { "zh": "先同时核对 VASCEPA、二十碳五烯酸乙酯、0.5 g 或 1 g、实际 NDC、瓶装数量、琥珀黄色胶囊、压印与目标市场。g/mg 是这个准确胶囊每粒的标示量，不是网页可计算的个人胶囊数，也不是与鱼油、其他 omega-3 产品或其他降脂产品的换算、叠加规则。", "en": "Check VASCEPA, icosapent ethyl, 0.5 g or 1 g, the actual NDC, bottle count, amber capsule, imprint and target market together. g/mg is the labelled amount in that exact capsule, not a web calculation for capsule count or a conversion/combining rule for fish oil, another omega-3 product or another lipid-related product." }, { "zh": "当前标签所示胶囊无刻痕；颜色、大小、椭圆形和压印只用于辅助核对，不能鉴定真伪，也不是自行打开、分用、减量或由一种包装替换另一种的指令。", "en": "The displayed label capsules are unscored. Colour, size, oval shape and imprint are supporting checks only; they cannot authenticate a product and are not instructions to self-open, split, reduce use or replace one package with another." }, { "zh": "当前标签包含心房颤动/扑动、出血、鱼类过敏以及与抗凝药或抗血小板药同用等阅读条目。请把全部处方药、非处方药、补充剂和实际药盒交给药师或开方团队逐项核对；网页不能把这些条目变成个人的“能否同服”或“能否替代鱼油”结论。", "en": "The current label includes reading items for atrial fibrillation/flutter, bleeding, fish allergy, and use with anticoagulant or antiplatelet medicines. Give every prescription medicine, OTC product, supplement and actual pack to a pharmacist or prescribing team for item-by-item review; this page cannot turn these items into an individual co-use or fish-oil-substitution conclusion." }, { "zh": "出现急性严重不适、呼吸困难、明显过敏样反应、异常出血或其他令人担心的症状时，应优先使用当地医疗支持；不要通过同时停换多种药或补充剂来试探原因。", "en": "With an acute serious concern, breathing difficulty, a marked allergy-like reaction, unusual bleeding or another worrying symptom, prioritise local medical support; do not test the cause by stopping or changing several medicines or supplements at once." } ], "source": { "id": "src_e3f016d82eabae04", "label": "DailyMed（NLM）：VASCEPA 二十碳五烯酸乙酯当前美国公开标签（Warnings, Drug Interactions and Patient Counseling；Amarin Pharma；SPL v21）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=9c1a2828-1583-4414-ab22-a60480e8e508&version=21", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-25", "reviewedAt": "2026-08-25" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "机制阅读：标签称作用机制尚未完全明确，不是自行选择或替代规则", "en": "Mechanism reading: the label says the mechanism is not completely understood, not a self-selection or substitution rule" }, "summary": { "zh": "当前美国标签写明二十碳五烯酸乙酯的作用机制尚未完全明确，并说明若干观察结果的直接临床意义不明确。这帮助读者避免把“EPA”“鱼油”或单一机制词当成自行选择、替代、叠加或停用产品的依据。", "en": "The current U.S. label states that the mechanism of action of icosapent ethyl is not completely understood and that the direct clinical significance of certain observations is unclear. This helps avoid treating “EPA”, “fish oil”, or a single mechanism phrase as a basis to self-select, substitute, combine or stop a product." }, "checks": [ { "zh": "标签中的 EPA 与脂质相关术语只帮助阅读当前文件，不能证明普通鱼油、其他 omega-3 产品或其他二十碳五烯酸乙酯包装与 VASCEPA 相等、可替代或可一起使用。", "en": "EPA and lipid-related terms in the label only help read the current document; they do not prove that ordinary fish oil, another omega-3 product or another icosapent-ethyl package equals VASCEPA, can replace it or can be used together." }, { "zh": "机制页不把任何人的化验结果、既往反应、过敏史、心律问题、出血风险、年龄、合并疾病或完整药单简化为“该不该选这款产品”的答案；已有检查或基因报告也须由专业人员结合这些资料解释。", "en": "A mechanism page does not reduce an individual's test results, prior reactions, allergy history, rhythm concerns, bleeding risk, age, coexisting conditions or complete medicine list to an answer about whether to choose this product; existing test or genetic reports also need professional interpretation with those materials." }, { "zh": "不要把机制、包装图或一个 g/mg 数字用于处理急性症状、补用、停用、换药或联用。现实问题必须回到准确产品的现行目标市场标签和药师或医生。", "en": "Do not use mechanism, a package image or one g/mg number to handle an acute symptom, make-up use, stopping, switching or co-use. Real questions must return to the current target-market label for the exact product and a pharmacist or clinician." } ], "source": { "id": "src_e3f016d82eabae04", "label": "DailyMed（NLM）：VASCEPA 二十碳五烯酸乙酯当前美国公开标签（Clinical Pharmacology；Amarin Pharma；SPL v21）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=9c1a2828-1583-4414-ab22-a60480e8e508&version=21", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-25", "reviewedAt": "2026-08-25" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "VASCEPA", "generic": "二十碳五烯酸乙酯", "dosageFormClass": "二十碳五烯酸乙酯口服胶囊：每粒 500 mg 或 1000 mg（美国当前公开标签所列；展示三个准确 NDC 瓶装）" }, "labelSource": { "id": "src_e3f016d82eabae04", "label": "DailyMed（NLM）：VASCEPA 二十碳五烯酸乙酯当前美国公开标签（Amarin Pharma；SPL v21，2026-03-23 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=9c1a2828-1583-4414-ab22-a60480e8e508&version=21", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-25", "reviewedAt": "2026-08-25" }, "productRoutes": [ { "source": { "id": "src_e3f016d82eabae04", "label": "DailyMed（NLM）：VASCEPA 二十碳五烯酸乙酯当前美国公开标签（Amarin Pharma；SPL v21，2026-03-23 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=9c1a2828-1583-4414-ab22-a60480e8e508&version=21", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-25", "reviewedAt": "2026-08-25" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-25", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-25", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "DailyMed 的当前 VASCEPA（icosapent ethyl）美国公开标签列示 0.5 g／1 g 口服胶囊、准确 NDC、瓶装数量、琥珀黄色胶囊外观及压印。本页帮助读者先把商品名、通用名、每粒标示量、准确包装、公开电子说明书和药物警戒阅读路径放在一起；它不把 mg、包装数量、EPA、鱼油或“同为降脂相关”转换为个人胶囊数、同服、轮换、停用、换药、替代或购买结论。", "history": "当前标签列示 Initial U.S. Approval: 2012，SPL v21 更新日期为 2026-03-23。0.5 g／1 g 是所示准确胶囊每粒的标签标示量，240 粒或 120 粒是准确瓶装的数量；它们不等于任何人的处方胶囊数，也不能与普通鱼油、其他 omega-3 产品、其他二十碳五烯酸乙酯包装、其他降脂产品或其他市场产品按数字自行换算、替换或叠加。", "sourceDocuments": [ { "id": "src_e3f016d82eabae04", "label": "DailyMed（NLM）：VASCEPA 二十碳五烯酸乙酯当前美国公开标签（Amarin Pharma；SPL v21，2026-03-23 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=9c1a2828-1583-4414-ab22-a60480e8e508&version=21", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-25", "reviewedAt": "2026-08-25" }, { "id": "src_5ed30b676fbb9773", "label": "FDA Drugs@FDA 官方检索入口（VASCEPA；NDA 202057）", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_lookup_entry", "documentKind": "regulatory_lookup", "market": "US", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } ], "applicationNumber": "NDA 202057", "approvalTimeline": [ { "date": "2012", "title": { "zh": "当前标签所列美国初始批准年份", "en": "Initial U.S. approval year listed in the current label" }, "detail": { "zh": "当前 VASCEPA 美国公开标签列示 Initial U.S. Approval: 2012。该年份只定位所引美国标签历史，不建立中国大陆、欧盟、日本或其他市场的批准、供应、可售资格、原研/仿制关系、鱼油/补充剂等同关系或个人适用性。", "en": "The current U.S. VASCEPA public label lists Initial U.S. Approval: 2012. This only locates the cited U.S. label history; it does not establish approval, supply, sale eligibility, originator/generic relationship, fish-oil/supplement equivalence or individual suitability in Mainland China, the EU, Japan or another market." }, "source": { "id": "src_e3f016d82eabae04", "label": "DailyMed（NLM）：VASCEPA 二十碳五烯酸乙酯当前美国公开标签（Amarin Pharma；SPL v21）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=9c1a2828-1583-4414-ab22-a60480e8e508&version=21", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-25", "reviewedAt": "2026-08-25" } }, { "date": "2026-03-23", "title": { "zh": "当前 SPL v21 更新日期", "en": "Current SPL v21 updated" }, "detail": { "zh": "DailyMed 当前 VASCEPA 公开标签的 Updated 日期为 2026-03-23，版本为 SPL v21。本页分别展示 0.5 g、NDC 52937-003-40、240 粒瓶装，以及 1 g、NDC 52937-001-20 与 NDC 52937-005-20 的 120 粒瓶装面板；不据此建立实际在售、库存、购买、个人胶囊数、联用、停用、换药、替代或其他市场状态。", "en": "The current DailyMed VASCEPA public label lists 23 Mar 2026 as Updated, version SPL v21. This page separately displays the 0.5 g/NDC 52937-003-40/240-capsule bottle and the 1 g/NDC 52937-001-20 and NDC 52937-005-20/120-capsule bottle panels; it does not establish actual availability, stock, purchase, individual capsule count, co-use, stopping, switching, substitution or another-market status." }, "source": { "id": "src_e3f016d82eabae04", "label": "DailyMed（NLM）：VASCEPA 二十碳五烯酸乙酯当前美国公开标签（Amarin Pharma；SPL v21，2026-03-23 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=9c1a2828-1583-4414-ab22-a60480e8e508&version=21", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-25", "reviewedAt": "2026-08-25" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "已链接当前公开标签与三组准确瓶装面板", "en": "Current public label and three exact bottle panels linked" }, "detail": { "zh": "本页分别展示 VASCEPA 二十碳五烯酸乙酯 0.5 g、NDC 52937-003-40、240 粒瓶装；1 g、NDC 52937-001-20、120 粒瓶装；1 g、NDC 52937-005-20、120 粒瓶装。它不用于鉴定真伪，也不建立实际在售、库存、购买、个人胶囊数、开始、停用、联用、换药、与鱼油或其他产品替代或可替代性。", "en": "This page separately displays VASCEPA icosapent ethyl 0.5 g/NDC 52937-003-40/240-capsule bottle; 1 g/NDC 52937-001-20/120-capsule bottle; and 1 g/NDC 52937-005-20/120-capsule bottle. It does not authenticate a product or establish actual availability, stock, purchase, individual capsule count, initiation, stopping, co-use, switching, substitution with fish oil or another product, or interchangeability." } }, { "market": { "zh": "中国大陆、欧盟、日本及其他市场", "en": "Mainland China, EU, Japan and other markets" }, "status": { "zh": "待逐项建立市场记录", "en": "Market record not established" }, "detail": { "zh": "不从美国标签、NDA、NDC、英文品牌、包装图、EPA、鱼油或标签主体推定当地商品名、批准、包装、供应、可售资格、原研/仿制关系、补充剂等同关系或可替代性；每个市场均须按当地现行监管资料单独核对。", "en": "No local trade name, approval, packaging, supply, sale eligibility, originator/generic relationship, supplement equivalence or interchangeability is inferred from the U.S. label, NDA, NDC, English brand, package image, EPA, fish oil or label entity; every market requires separate checking against current local regulatory material." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "0.5 g、1 g 与瓶装数量能不能用来自己决定胶囊数，或用普通鱼油替代、与其他降脂产品同服？", "en": "Can 0.5 g, 1 g and bottle count be used to decide my own capsule count, replace it with ordinary fish oil, or use it with another lipid-related product?" }, "answer": { "zh": "不能。这些字段只识别所引美国标签中的准确 VASCEPA 胶囊和包装。名称相似、同含 EPA、相近 g/mg 数字、包装照片或同为降脂相关产品，均不建立自行开始、增加、补用、停用、联用、轮换或替代关系；请带现行药盒、处方和完整药单请药师或开方团队复核。", "en": "No. These fields only identify the exact VASCEPA capsules and packages in the cited U.S. label. A similar name, EPA content, nearby g/mg number, package photo or lipid-related context does not establish self-initiation, increase, make-up use, stopping, co-use, alternation or substitution; take the current pack, prescription and complete medicine list to a pharmacist or prescribing team for review." } }, { "question": { "zh": "为什么页面提到出血、心律、过敏和联用药，却不告诉我自己是否应改药或停用？", "en": "Why does the page mention bleeding, rhythm, allergy and co-medications without telling me whether to change or stop medicine?" }, "answer": { "zh": "这些是当前美国标签中警示、相互作用和患者咨询段落的阅读入口，不是个体化风险判断或治疗决策。出现急性严重不适或对现行处方有担忧时，请使用当地医疗支持；药师或医生需要结合准确产品、病史、检查和完整药单逐项复核。", "en": "These are reading entry points for the current U.S. label's warnings, interactions and patient-counselling sections, not an individual risk assessment or treatment decision. For an acute serious concern or worry about the current prescription, use local medical support; a pharmacist or clinician needs the exact product, history, tests and complete medicine list for item-by-item review." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "dosage-forms-are-part-of-medicine-identity", "how-to-read-a-drug-label" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/vascepa/", "en": "https://origindrug.com/en/drugs/vascepa/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "repatha", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-22", "status": "published_traceable_archive" }, "names": { "brand": "REPATHA", "generic": "依洛尤单抗", "aliases": [ "REPATHA", "evolocumab", "依洛尤单抗", "瑞百安" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "心血管", "sourceArchiveMarket": "美国 DailyMed 当前 REPATHA（evolocumab）皮下注射液公开标签；页面 2026-08-19 更新、标签 2026-07 修订。本记录只对应美国标签所列产品，不推定中国大陆或其他市场的当前批准、供应、报销或可得性。", "dosageFormClass": "皮下注射液：140 mg/mL 预充式单剂量笔、SureClick® 自动注射器或预充式单剂量注射器（DailyMed 当前美国公开标签所列；本页精确展示 2 支自动注射器纸盒）", "dosageFormClassCode": "subcutaneous_injection", "route": "皮下给药（准确装置和使用方法仅以实际包装中的现行说明书及专业培训为准）", "routeCode": "subcutaneous", "historicalApprovalEntry": "2015（DailyMed 当前美国公开标签所列初始批准）", "archiveSponsorText": "Amgen USA Inc. / DailyMed 美国公开标签" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [ "alirocumab", "阿利西尤单抗", "inclisiran", "英克司兰", "evolocumab tablet", "依洛尤单抗片" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-repatha-evolocumab-140mg-ml-two-autoinjector-carton-ndc-72511-760-02", "marketCode": "US", "labelVersion": { "zh": "DailyMed 美国当前公开标签（页面 2026-08-19 更新；标签 2026-07 修订）", "en": "Current U.S. DailyMed public label (page updated 19 Aug 2026; label revised Jul 2026)" }, "dosageForm": { "zh": "皮下注射液：单剂量自动注射器", "en": "subcutaneous injection: single-dose autoinjector" }, "route": { "zh": "皮下（标签产品身份字段）", "en": "subcutaneous (label product-identity field)" }, "routeCodes": [ "subcutaneous" ], "productCode": "NDC 72511-760-02", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "concentration", "primaryDisplay": { "zh": "REPATHA 依洛尤单抗 140 mg/mL；2 支自动注射器纸盒（NDC 72511-760-02）", "en": "REPATHA evolocumab 140 mg/mL; carton of 2 autoinjectors (NDC 72511-760-02)" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=repatha_amgenusa-115.jpg&setid=cd61e902-166d-4aa6-9f3c-a18c1008d07e&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "依洛尤单抗", "en": "evolocumab" }, "value": 140, "unit": "mg", "basisCode": "concentration", "basisLabel": { "zh": "每 mL 的标签浓度；不是个人注射量或换算", "en": "labelled concentration per mL; not an individual injection amount or conversion" } } ], "concentration": { "basisCode": "mass_per_volume", "notation": "140 mg/mL", "numerator": { "value": 140, "unit": "mg" }, "denominator": { "value": 1, "unit": "mL" }, "display": { "zh": "140 mg/mL（标签浓度；不是个人注射量）", "en": "140 mg/mL (labelled concentration; not an individual injection amount)" } }, "container": { "typeCode": "single_dose_autoinjector", "typeLabel": { "zh": "单剂量自动注射器", "en": "single-dose autoinjector" }, "fill": null, "countPerPackage": 2, "countUnit": { "zh": "支/纸盒", "en": "autoinjectors per carton" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-22", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 2, "unit": { "zh": "支单剂量自动注射器/纸盒", "en": "single-dose autoinjectors per carton" } }, "physicalClues": { "color": { "zh": "以实际美国公开标签纸盒为准", "en": "refer to the exact U.S. public-label carton" }, "shape": { "zh": "2 支自动注射器纸盒", "en": "carton of 2 autoinjectors" }, "imprint": "REPATHA / evolocumab / 140 mg/mL / NDC 72511-760-02", "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_1d21e07b9c9d0ea7", "label": "DailyMed（NLM）：REPATHA 依洛尤单抗当前美国公开标签（Amgen USA；页面 2026-08-19 更新，标签 2026-07 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=cd61e902-166d-4aa6-9f3c-a18c1008d07e", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-repatha-evolocumab-140mg-ml-two-autoinjector-carton-ndc-72511-760-02", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=repatha_amgenusa-115.jpg&setid=cd61e902-166d-4aa6-9f3c-a18c1008d07e&type=img", "alt": "REPATHA 依洛尤单抗在美国 DailyMed 当前标签中的 140 mg/mL、NDC 72511-760-02、2 支自动注射器纸盒展示面", "archiveMarket": "美国", "labelVersion": "DailyMed 美国当前公开标签（页面 2026-08-19 更新；标签 2026-07 修订）", "presentation": "REPATHA 依洛尤单抗：140 mg/mL，NDC 72511-760-02，2 支单剂量自动注射器纸盒。", "notice": "此图只对应美国 DailyMed 当前标签中的 REPATHA、依洛尤单抗、140 mg/mL、NDC 72511-760-02 与 2 支单剂量自动注射器纸盒。它只帮助核对品牌、通用名、标签浓度、装置、包装数量和来源；不用于鉴定真伪，也不证明其他自动注射器、预充式笔、预充式注射器、其他包装、其他市场、当前可得性、原研身份、可替代性，或任何个人的注射量、时间、开始、停用、联用或换药方案。", "source": { "id": "src_1d21e07b9c9d0ea7", "label": "DailyMed（NLM）：REPATHA 依洛尤单抗当前美国公开标签（Amgen USA；页面 2026-08-19 更新，标签 2026-07 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=cd61e902-166d-4aa6-9f3c-a18c1008d07e", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "REPATHA 说明书放大阅读：140 mg/mL 是准确注射产品身份，不是个人注射方案", "en": "REPATHA label reading: 140 mg/mL identifies an exact injection product; it is not an individual injection plan" }, "summary": { "zh": "本模块只阅读 DailyMed 当前美国标签中的 REPATHA、依洛尤单抗、皮下注射液、140 mg/mL 和所列单剂量装置类型。它将产品身份与安全核对线索放在一起，但不提供个人注射、给药时间、漏用处理、开始、停用、联用、换药或购买方案。", "en": "This module reads only REPATHA, evolocumab, subcutaneous injection, 140 mg/mL and the listed single-dose device types in the current U.S. DailyMed label. It places product identity and safety-review cues together, but provides no individual injection, timing, missed-use, initiation, stopping, co-use, switching or purchase plan." }, "checks": [ { "zh": "把 REPATHA、依洛尤单抗、皮下注射液、准确装置、140 mg/mL、实际包装和目标市场一起核对。这个数字是标签上的产品浓度/身份线索，不是网页可以换算成个人每次注射量、频率或时间表的规则，也不能据此与片剂、另一种注射产品或另一市场包装自行互换。", "en": "Check REPATHA, evolocumab, subcutaneous injection, the exact device, 140 mg/mL, the actual pack and target market together. This figure is a labelled concentration/identity cue, not a web rule that can calculate anyone's injection amount, frequency or schedule, and it cannot self-convert tablets, another injection product or another-market pack." }, { "zh": "当前美国标签列有预充式单剂量笔、SureClick® 自动注射器和预充式单剂量注射器；部分针头保护套含天然橡胶衍生物，标签提示乳胶敏感者需要专业人员核对准确展示型。包装名称相似、共享通用名或照片相似，都不足以确认装置、材料或使用方式。", "en": "The current U.S. label lists a prefilled single-dose pen, SureClick® autoinjector and prefilled single-dose syringe; some needle covers contain a natural-rubber derivative, so the label flags exact-presentation review for people sensitive to latex. Similar pack names, a shared generic name or similar photos do not establish device, materials or use." }, { "zh": "标签列出严重超敏反应（包括血管性水肿）和注射部位反应等安全信息。出现呼吸困难、面部/口唇/咽喉肿胀、晕厥或其他急性严重不适时，应优先使用当地紧急医疗渠道；网页不能替代对此类症状的现场评估，也不建议自行以停用、补用或换药处理。", "en": "The label includes safety information on serious hypersensitivity, including angioedema, and injection-site reactions. With breathing difficulty, swelling of the face, lips or throat, fainting or another acute serious concern, prioritise local emergency care; a webpage cannot replace assessment of such symptoms and does not direct self-stopping, make-up use or switching." }, { "zh": "若药单中同时有阿托伐他汀、瑞舒伐他汀、依折麦布、其他降脂注射剂、抗凝药、非处方药、草本或补充剂，应将所有实际包装与完整药单交给药师或开方团队复核。共同的“降脂”目标不表示可以自行叠加、轮换、按 mg 换算或替代。", "en": "If atorvastatin, rosuvastatin, ezetimibe, another lipid-lowering injection, anticoagulants, OTC products, herbs or supplements are also on the list, have a pharmacist or prescribing team review every actual pack and the full medicine list. A shared “lipid-lowering” goal does not make products self-combinable, alternatable, milligram-convertible or substitutable." } ], "source": { "id": "src_1d21e07b9c9d0ea7", "label": "DailyMed (NLM): current REPATHA evolocumab U.S. public label (page updated 2026-08-19; label revised 2026-07; product identity, device and safety information)", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=cd61e902-166d-4aa6-9f3c-a18c1008d07e", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "依洛尤单抗怎样起作用：标签将其归为 PCSK9 抑制剂", "en": "How evolocumab works: the label classifies it as a PCSK9 inhibitor" }, "summary": { "zh": "DailyMed 当前标签将 REPATHA 描述为 PCSK9 抑制剂。这个机制词帮助理解标签的药理分类，却不预测个人的 LDL-C 数值、心血管风险、耐受性、注射方案、是否适合联用或是否需要换药。", "en": "The current DailyMed label describes REPATHA as a PCSK9 inhibitor. This mechanism term helps explain the label's pharmacologic classification; it does not predict an individual's LDL-C value, cardiovascular risk, tolerance, injection plan, suitability for co-use or whether to switch." }, "checks": [ { "zh": "“PCSK9 抑制剂”是药理路径用语，不表示任意胆固醇异常都适用，也不表示与他汀、依折麦布、阿利西尤单抗或英克司兰可以自行并用、轮换或互换。产品、装置、目标市场标签、化验与完整药单必须由专业人员逐项复核。", "en": "“PCSK9 inhibitor” is pharmacologic-pathway wording; it does not mean every cholesterol concern is suitable, nor does it permit self-combination, alternation or exchange with a statin, ezetimibe, alirocumab or inclisiran. The product, device, target-market label, testing and full medicine list need item-by-item professional review." }, { "zh": "同样涉及 LDL-C、动脉粥样硬化或家族性高胆固醇血症的文字，不足以判断任何人的诊断、遗传情况、风险分层或是否需要基因检测。标签列出适用人群不等于网页可以替代临床判断；涉及家族史、化验或基因报告时，应由熟悉实际资料的团队解读。", "en": "Shared wording about LDL-C, atherosclerosis or familial hypercholesterolemia is insufficient to determine anyone's diagnosis, genetic context, risk classification or need for genetic testing. A labelled population does not replace clinical judgement; family history, laboratory results or genetic reports should be interpreted by a team familiar with the actual information." }, { "zh": "机制解释不能替代药物警戒、准确装置说明书或多药核对。开始任何新产品、发生疑似不良反应、装置/包装不一致或希望改变治疗时，应先让药师或开方团队核对实际包装、目标市场文件与完整药单。", "en": "A mechanism explanation does not replace pharmacovigilance, the exact device instructions or multi-medicine review. Before starting any new product, with a suspected adverse reaction, a device/pack mismatch or a contemplated treatment change, first have a pharmacist or prescribing team review the actual pack, target-market documents and complete medicine list." } ], "source": { "id": "src_1d21e07b9c9d0ea7", "label": "DailyMed (NLM): current REPATHA evolocumab U.S. public label (page updated 2026-08-19; Clinical Pharmacology)", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=cd61e902-166d-4aa6-9f3c-a18c1008d07e", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "REPATHA", "generic": "依洛尤单抗", "dosageFormClass": "皮下注射液：140 mg/mL 预充式单剂量笔、SureClick® 自动注射器或预充式单剂量注射器（DailyMed 当前美国公开标签所列；本页精确展示 2 支自动注射器纸盒）" }, "labelSource": { "id": "src_1d21e07b9c9d0ea7", "label": "DailyMed (NLM): current REPATHA evolocumab U.S. public label (page updated 2026-08-19; label revised 2026-07)", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=cd61e902-166d-4aa6-9f3c-a18c1008d07e", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" }, "productRoutes": [ { "source": { "id": "src_1d21e07b9c9d0ea7", "label": "DailyMed (NLM): current REPATHA evolocumab U.S. public label (page updated 2026-08-19; label revised 2026-07)", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=cd61e902-166d-4aa6-9f3c-a18c1008d07e", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-22", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_81862f01661fd28d", "label": "FDA: REPATHA evolocumab U.S. prescribing information (revised 2025-08; historical label version)", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/125522s045lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-22", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "DailyMed 当前美国公开标签将 REPATHA 列为依洛尤单抗皮下注射液，并将其归为 PCSK9 抑制剂。本页帮助读者把商品名、通用名、准确注射装置、标签浓度、美国标签和药物警戒入口逐项对应；它不把包装数字、给药途径或降脂目标变成个人注射、开始、停用、联用、换药或购买建议。", "history": "DailyMed 当前标签列示 REPATHA 的美国初始批准为 2015，并标示为生物制品许可申请产品。该档案仅定位该美国公开标签；同类降脂注射剂、同通路产品、其他市场产品及不同装置，均必须按实际药盒和目标市场现行官方资料分别核对。", "sourceDocuments": [ { "id": "src_1d21e07b9c9d0ea7", "label": "DailyMed (NLM): current REPATHA evolocumab U.S. public label (page updated 2026-08-19; label revised 2026-07)", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=cd61e902-166d-4aa6-9f3c-a18c1008d07e", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" }, { "id": "src_81862f01661fd28d", "label": "FDA: REPATHA evolocumab U.S. prescribing information (revised 2025-08; historical label version)", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/125522s045lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } ], "applicationNumber": "BLA 125522", "approvalTimeline": [ { "date": "2015", "title": { "zh": "FDA 标签所列美国初始批准年份", "en": "Initial U.S. approval year listed in the FDA label" }, "detail": { "zh": "本页链接的 FDA 标签档案列示 Initial U.S. Approval: 2015。该历史定位不等同于当前批准、可得性、持有人或其他市场状态。", "en": "The FDA label archive linked here lists Initial U.S. Approval: 2015. This historical locator is not a conclusion about current approval, availability, holder or another market." }, "source": { "id": "src_1d21e07b9c9d0ea7", "label": "DailyMed: current REPATHA evolocumab U.S. public label", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=cd61e902-166d-4aa6-9f3c-a18c1008d07e", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "date": "2026-07", "title": { "zh": "FDA 标签档案版本", "en": "FDA label archive version" }, "detail": { "zh": "本页链接 2026-07 的 FDA 标签档案作为可复核阅读入口。现行标签、规格、适应症和安全信息必须另行以目标市场当前文件核对。", "en": "This page links the 2026-07 FDA label archive as a traceable reading entry point. Current labeling, strength, indication and safety information require separate verification against the target market’s current document." }, "source": { "id": "src_1d21e07b9c9d0ea7", "label": "DailyMed: current REPATHA evolocumab U.S. public label", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=cd61e902-166d-4aa6-9f3c-a18c1008d07e", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "已链接公开标签档案", "en": "Public label archive linked" }, "detail": { "zh": "仅对应本页所列 FDA 文件。", "en": "Only the FDA document listed on this page is linked." } }, { "market": { "zh": "中国大陆、欧盟、日本", "en": "Mainland China, EU, Japan" }, "status": { "zh": "待逐项建立市场记录", "en": "Market record not established" }, "detail": { "zh": "不从美国标签档案推定当地批准、持有人、规格、供应或可售资格。", "en": "No local approval, holder, strength, supply or sale-eligibility conclusion is inferred from the U.S. label archive." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "标签档案能代表现在的产品信息吗？", "en": "Does a label archive represent current product information?" }, "answer": { "zh": "不能自动代表。档案用于定位来源；需要以目标市场的现行官方标签逐项复核。", "en": "Not automatically. The archive locates a source; each point needs verification against the target market’s current official label." } }, { "question": { "zh": "为什么这里不展示价格或原研/仿制结论？", "en": "Why are price and originator/generic conclusions not shown?" }, "answer": { "zh": "这些结论需要产品、剂型、规格、包装、市场、日期和原始记录分别齐全并经人工审核；单一标签文件不足以支持。", "en": "Those conclusions require separately complete and human-reviewed product, dosage-form, strength, pack, market, date and primary-record fields; one label file is insufficient." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "dosage-forms-are-part-of-medicine-identity", "medicine-label-for-everyday-questions", "how-to-read-a-drug-label" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/repatha/", "en": "https://origindrug.com/en/drugs/repatha/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "eliquis", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-20", "status": "published_traceable_archive" }, "names": { "brand": "Eliquis", "generic": "阿哌沙班", "aliases": [ "エリキュース", "apixaban" ], "marketBrandNames": [ { "name": "エリキュース", "market": { "zh": "日本", "en": "Japan" }, "evidenceStatus": "current_regulatory_record", "note": { "zh": "PMDA 当前产品页列示エリキュース錠 2.5 mg、5 mg及阿哌沙班成分；仅作为日文名称、片剂与市场记录的核对入口，不确认其他剂型、包装、供应、可售资格或可自行换药。", "en": "The current PMDA product page lists ELIQUIS (エリキュース) 2.5 mg and 5 mg tablets with apixaban; it is only a check point for the Japanese name, tablet form and market record, not another form, pack, supply, availability or self-directed switching." }, "source": { "id": "src_9deb014111f17795", "label": "PMDA：エリキュース錠 2.5 mg／5 mg 当前产品页", "url": "https://www.pmda.go.jp/PmdaSearch/rdDetail/iyaku/3339004F1029_1?user=1", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } } ], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "心血管", "sourceArchiveMarket": "美国公开监管标签档案；日本 PMDA 当前产品记录（エリキュース錠 2.5 mg／5 mg）", "dosageFormClass": "口服片剂：2.5 mg、5 mg；FDA 2025 标签另列儿科口服混悬用途制剂，应与成人片剂分开核对", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "2012（FDA 2025 标签所列美国初始批准）", "archiveSponsorText": "Bristol Myers Squibb / Pfizer / FDA 与 DailyMed 公开标签档案" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [ "ELIQUIS SPRINKLE", "ELIQUIS 0.15 mg", "ELIQUIS 0.5 mg", "tablets for oral suspension" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-eliquis-tablet-2-5mg-ndc-0003-0893-21", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v30，2025-05-05 发布", "en": "DailyMed SPL v30, published 5 May 2025" }, "dosageForm": { "zh": "ELIQUIS 阿哌沙班成人口服薄膜衣片", "en": "ELIQUIS apixaban adult film-coated oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 0003-0893-21", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片 2.5 mg；60 片瓶装", "en": "2.5 mg per tablet; 60-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=e9481622-7cc6-418a-acb6-c5450daae9b0&type=img&name=apixa-2.5mg-label.jpg.jpg", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "阿哌沙班", "en": "apixaban" }, "value": 2.5, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标示量；不是个人片数、停药或换药规则", "en": "labelled amount per tablet; not an individual's tablet count, interruption or switching rule" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 60, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-20", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 60, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "黄色", "en": "yellow" }, "shape": { "zh": "圆形、双凸薄膜衣片", "en": "round biconvex film-coated tablet" }, "imprint": "893 / 2½", "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_f362259220a403fe", "label": "DailyMed（NLM）：ELIQUIS 阿哌沙班当前美国公开标签（Bristol Myers Squibb / Pfizer；SPL v30，2025-05-05 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=e9481622-7cc6-418a-acb6-c5450daae9b0", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-eliquis-tablet-5mg-ndc-0003-0894-21", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v30，2025-05-05 发布", "en": "DailyMed SPL v30, published 5 May 2025" }, "dosageForm": { "zh": "ELIQUIS 阿哌沙班成人口服薄膜衣片", "en": "ELIQUIS apixaban adult film-coated oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 0003-0894-21", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片 5 mg；60 片瓶装", "en": "5 mg per tablet; 60-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=e9481622-7cc6-418a-acb6-c5450daae9b0&type=img&name=apixa-5.0mg-label.jpg.jpg", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "阿哌沙班", "en": "apixaban" }, "value": 5, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标示量；不是个人片数、停药或换药规则", "en": "labelled amount per tablet; not an individual's tablet count, interruption or switching rule" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 60, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-20", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 60, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "粉红色", "en": "pink" }, "shape": { "zh": "椭圆形、双凸薄膜衣片", "en": "oval biconvex film-coated tablet" }, "imprint": "894 / 5", "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_f362259220a403fe", "label": "DailyMed（NLM）：ELIQUIS 阿哌沙班当前美国公开标签（Bristol Myers Squibb / Pfizer；SPL v30，2025-05-05 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=e9481622-7cc6-418a-acb6-c5450daae9b0", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-eliquis-tablet-5mg-ndc-0003-0894-21", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=e9481622-7cc6-418a-acb6-c5450daae9b0&type=img&name=apixa-5.0mg-label.jpg.jpg", "alt": "ELIQUIS 阿哌沙班在美国 DailyMed 当前公开标签中的 5 mg、NDC 0003-0894-21、60 片瓶装展示面", "archiveMarket": "美国", "labelVersion": "DailyMed SPL v30（2025-05-05 发布）", "presentation": "ELIQUIS 阿哌沙班：每片 5 mg，NDC 0003-0894-21，60 片瓶装展示面。", "notice": "此图只对应美国 DailyMed 当前标签中的 ELIQUIS、阿哌沙班 5 mg、NDC 0003-0894-21 与 60 片瓶装。它只帮助核对品牌、通用名、每片标示量、片剂、包装数量与来源；不用于鉴定真伪，也不证明 2.5 mg、儿童口服混悬用途制剂、启动包装、其他包装、其他市场、当前可得性、原研身份、可替代性，或任何个人的片数、停药、漏用补救、联用或换药方案。", "source": { "id": "src_f362259220a403fe", "label": "DailyMed（NLM）：ELIQUIS 阿哌沙班当前美国公开标签（Bristol Myers Squibb / Pfizer；SPL v30，2025-05-05 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=e9481622-7cc6-418a-acb6-c5450daae9b0", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "ELIQUIS 说明书放大阅读：片剂、不同 mg 与抗凝药不能自行停用", "en": "ELIQUIS label reading: tablets, different mg strengths and no self-stopping of an anticoagulant" }, "summary": { "zh": "本模块以 FDA 与 DailyMed 的 2025 美国公开标签为阅读入口，帮助核对 ELIQUIS、阿哌沙班、成人口服片剂、2.5 mg/5 mg 包装文字，并把联用、出血和操作前后的问题带回专业核对；它不生成个体剂量、停药或转换方案。", "en": "This module uses 2025 U.S. FDA and DailyMed public labels as a reading entry point for ELIQUIS, apixaban, adult oral tablets and 2.5 mg/5 mg package wording, and brings combination, bleeding and procedure questions back to professional review; it does not create an individual dose, stop or switch plan." }, "checks": [ { "zh": "先同时核对 ELIQUIS、通用名阿哌沙班（apixaban）、成人口服片剂、每片标示强度和目标市场。2.5 mg、5 mg 是标签所列片剂强度线索；它们不是任何人应服用几片的答案，也不能把不同剂型按 mg 自行互换。", "en": "Check ELIQUIS, the generic name apixaban, adult oral tablet form, stated strength per tablet and target market together. 2.5 mg and 5 mg are labelled tablet-strength clues; they are not an answer to how many tablets anyone should take and do not make different dosage forms self-interchangeable by milligrams." }, { "zh": "该标签提示过早停用会增加血栓事件风险。无论是担心出血、看到不同规格、药盒用完或考虑手术牙科操作，都不应据此自行停药、跳过、补服或改用另一种“抗凝/抗血栓”药。", "en": "The label warns that premature discontinuation increases thrombotic-event risk. Whether the concern is bleeding, a different strength, a finished pack, surgery or dental work, do not self-stop, skip, make up or substitute another “blood-thinning” medicine." }, { "zh": "阿司匹林、止痛抗炎药、其他影响凝血的药物、部分抗抑郁药和草本/保健品都应完整告知开方团队和药师。网页不能把相互作用信息变成个人的“能用/不能用”清单。", "en": "Aspirin, anti-inflammatory pain medicines, other medicines affecting clotting, some antidepressants and herbs or supplements all belong in the complete list for the prescribing team and pharmacist. A webpage cannot turn interaction information into a personal “can/cannot use” list." }, { "zh": "出现异常出血或计划侵入性操作时，应按当地医疗团队给出的具体指示处理；本页图片不能用于确认手中产品真伪或决定临时停药。", "en": "For unusual bleeding or a planned invasive procedure, follow the specific instructions of the local care team. This page's image cannot authenticate a product in hand or decide a temporary interruption." } ], "source": { "id": "src_f362259220a403fe", "label": "DailyMed（NLM）：ELIQUIS 公开标签（Bristol Myers Squibb / Pfizer，2025-04 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=e9481622-7cc6-418a-acb6-c5450daae9b0", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "阿哌沙班怎样起作用：它选择性抑制凝血因子 Xa", "en": "How apixaban works: it selectively inhibits coagulation factor Xa" }, "summary": { "zh": "FDA 公开标签说明阿哌沙班选择性抑制游离和凝块结合的凝血因子 Xa 及凝血酶原酶活性，进而降低凝血酶生成和血栓形成。这说明的是凝血通路中的作用位置，不为任何人决定剂量、停药、转换或与其他抗凝/抗血小板药的组合。", "en": "The FDA public label explains that apixaban selectively inhibits free and clot-bound factor Xa and prothrombinase activity, reducing thrombin generation and thrombus development. This identifies a location in the coagulation pathway; it does not decide anyone's dose, interruption, conversion or combination with other anticoagulant or antiplatelet medicines." }, "checks": [ { "zh": "“同为因子 Xa 抑制剂”不是可互换或可叠加的理由。药物名称、强度、给药时间、适用情形、肾肝功能和完整药单都可能影响专业转换安排。", "en": "“Both are factor Xa inhibitors” is not a reason to interchange or combine them. Medicine name, strength, dosing time, use context, kidney and liver function, and the complete medicine list can all affect a professionally managed conversion." }, { "zh": "机制也不能把“防血栓”和“出血风险”平衡成个人指令。异常出血、计划手术或牙科操作、漏服或拿到不同包装时，应按医疗团队的具体指示处理，不要依据网页自停、补服或加用另一种药。", "en": "Mechanism also cannot turn the balance between clot prevention and bleeding risk into personal instructions. With unusual bleeding, planned surgery or dental work, missed use or a different pack, follow the specific care-team instructions; do not self-stop, make up or add another medicine from a webpage." }, { "zh": "本页机制不能取代相互作用核对。新开的处方药、非处方止痛药、抗血小板药、草本和保健品都应连同完整药单由医生或药师复核。", "en": "This page's mechanism cannot replace an interaction review. New prescriptions, OTC pain medicines, antiplatelet medicines, herbs and supplements all need review with the complete medicine list by a clinician or pharmacist." } ], "source": { "id": "src_db4dca754540adc9", "label": "FDA：ELIQUIS 2025-04 美国处方信息（临床药理）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/202155s039s040lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "Eliquis", "generic": "阿哌沙班", "dosageFormClass": "口服片剂：2.5 mg、5 mg；FDA 2025 标签另列儿科口服混悬用途制剂，应与成人片剂分开核对" }, "labelSource": { "id": "src_f362259220a403fe", "label": "DailyMed（NLM）：ELIQUIS 公开标签（Bristol Myers Squibb / Pfizer，2025-04 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=e9481622-7cc6-418a-acb6-c5450daae9b0", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "productRoutes": [ { "source": { "id": "src_f362259220a403fe", "label": "DailyMed（NLM）：ELIQUIS 公开标签（Bristol Myers Squibb / Pfizer，2025-04 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=e9481622-7cc6-418a-acb6-c5450daae9b0", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_db4dca754540adc9", "label": "FDA：ELIQUIS 2025-04 美国处方信息（NDA 202155 / 220073）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/202155s039s040lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_9deb014111f17795", "label": "PMDA：エリキュース錠 2.5 mg／5 mg 当前产品页", "url": "https://www.pmda.go.jp/PmdaSearch/rdDetail/iyaku/3339004F1029_1?user=1", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "status": "product_level_public_record_verified", "authority": { "zh": "PMDA", "en": "PMDA" }, "market": { "zh": "日本", "en": "Japan" }, "recordType": { "zh": "监管产品记录", "en": "Regulatory product record" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "FDA 与 DailyMed 的 ELIQUIS（apixaban）2025 美国公开标签将成人口服片剂列为 2.5 mg、5 mg，并列出美国初始批准年份为 2012；同份 FDA 标签还列有用于口服混悬液的不同儿科剂型。本页以成人片剂与公开标签为阅读入口，不把不同剂型、不同人群或其他市场产品自动混为可互换产品，也不推定各市场当前批准、供应或可售资格。", "history": "“ELIQUIS”“阿哌沙班”“2.5 mg/5 mg”“片剂”与口服混悬用途制剂是不同层次的身份信息，必须连同目标市场、完整药单和现行文件一起核对。抗凝药的漏服、出血、手术/牙科操作、换药或与其他抗凝/抗血小板药联用均不能从网页自行决定。", "sourceDocuments": [ { "id": "src_db4dca754540adc9", "label": "FDA：ELIQUIS 2025-04 美国处方信息（NDA 202155 / 220073）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/202155s039s040lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_f362259220a403fe", "label": "DailyMed（NLM）：ELIQUIS 公开标签（Bristol Myers Squibb / Pfizer，2025-04 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=e9481622-7cc6-418a-acb6-c5450daae9b0", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_5ed30b676fbb9773", "label": "FDA Drugs@FDA 官方检索入口", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_lookup_entry", "documentKind": "regulatory_lookup", "market": "US", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_9deb014111f17795", "label": "PMDA：エリキュース錠 2.5 mg／5 mg 当前产品页", "url": "https://www.pmda.go.jp/PmdaSearch/rdDetail/iyaku/3339004F1029_1?user=1", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } ], "applicationNumber": "NDA 202155 / 220073", "approvalTimeline": [ { "date": "2012", "title": { "zh": "FDA 标签所列美国初始批准年份", "en": "Initial U.S. approval year listed in the FDA label" }, "detail": { "zh": "本页链接的 FDA 标签档案列示 Initial U.S. Approval: 2012。该历史定位不等同于当前批准、可得性、持有人或其他市场状态。", "en": "The FDA label archive linked here lists Initial U.S. Approval: 2012. This historical locator is not a conclusion about current approval, availability, holder or another market." }, "source": { "id": "src_db4dca754540adc9", "label": "FDA: ELIQUIS prescribing information", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/202155s039s040lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, { "date": "2025-04", "title": { "zh": "FDA 标签档案版本", "en": "FDA label archive version" }, "detail": { "zh": "本页链接 2025-04 的 FDA 标签档案作为可复核阅读入口。现行标签、规格、适应症和安全信息必须另行以目标市场当前文件核对。", "en": "This page links the 2025-04 FDA label archive as a traceable reading entry point. Current labeling, strength, indication and safety information require separate verification against the target market’s current document." }, "source": { "id": "src_db4dca754540adc9", "label": "FDA: ELIQUIS prescribing information", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/202155s039s040lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "已链接公开标签档案", "en": "Public label archive linked" }, "detail": { "zh": "仅对应本页所列 FDA 文件。", "en": "Only the FDA document listed on this page is linked." } }, { "market": { "zh": "中国大陆、欧盟、日本", "en": "Mainland China, EU, Japan" }, "status": { "zh": "待逐项建立市场记录", "en": "Market record not established" }, "detail": { "zh": "不从美国标签档案推定当地批准、持有人、规格、供应或可售资格。", "en": "No local approval, holder, strength, supply or sale-eligibility conclusion is inferred from the U.S. label archive." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "标签档案能代表现在的产品信息吗？", "en": "Does a label archive represent current product information?" }, "answer": { "zh": "不能自动代表。档案用于定位来源；需要以目标市场的现行官方标签逐项复核。", "en": "Not automatically. The archive locates a source; each point needs verification against the target market’s current official label." } }, { "question": { "zh": "为什么这里不展示价格或原研/仿制结论？", "en": "Why are price and originator/generic conclusions not shown?" }, "answer": { "zh": "这些结论需要产品、剂型、规格、包装、市场、日期和原始记录分别齐全并经人工审核；单一标签文件不足以支持。", "en": "Those conclusions require separately complete and human-reviewed product, dosage-form, strength, pack, market, date and primary-record fields; one label file is insufficient." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "how-to-read-a-drug-label", "regulatory-sources-first" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/eliquis/", "en": "https://origindrug.com/en/drugs/eliquis/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "xarelto", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-24", "status": "published_traceable_archive" }, "names": { "brand": "Xarelto", "generic": "利伐沙班", "aliases": [ "rivaroxaban" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "心血管", "sourceArchiveMarket": "美国 DailyMed 当前 XARELTO 片剂/口服混悬液同一标签；本页精确展示 2.5 mg、60 片瓶装（NDC 50458-577-60）及 10 mg、15 mg、20 mg 各 30 片瓶装（NDC 50458-580-30、50458-578-30、50458-579-30）", "dosageFormClass": "本页精确展示四种 XARELTO 利伐沙班口服薄膜衣片瓶装身份；启动包装与口服混悬液不并入这些片剂包装", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "2011（当前标签所列美国初始批准）", "archiveSponsorText": "Janssen 当前美国公开标签；FDA 历史监管档案" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [ "XARELTO for oral suspension", "XARELTO oral suspension", "XARELTO Starter Pack" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-xarelto-rivaroxaban-tablet-2-5mg-60-bottle-ndc-50458-577-60", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v64，2026-04-06 发布", "en": "DailyMed SPL v64, published 6 Apr 2026" }, "dosageForm": { "zh": "XARELTO 利伐沙班薄膜衣片", "en": "XARELTO rivaroxaban film-coated tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 50458-577-60", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片 2.5 mg；60 片瓶装", "en": "2.5 mg per tablet; 60-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=10db92f9-2300-4a80-836b-673e1ae91610&type=img&name=Xarelto-34.jpg", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "利伐沙班", "en": "rivaroxaban" }, "value": 2.5, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标示量；不是个人片数、停药或换药规则", "en": "labelled amount per tablet; not an individual's tablet count, interruption or switching rule" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 60, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-20", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 60, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "浅黄色", "en": "light yellow" }, "shape": { "zh": "圆形薄膜衣片", "en": "round film-coated tablet" }, "imprint": "2.5 / Xa", "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_2f3781ea4c649b1e", "label": "DailyMed（NLM）：XARELTO 利伐沙班当前美国公开标签（Janssen；SPL v64，2026-04-06 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=10db92f9-2300-4a80-836b-673e1ae91610", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-xarelto-rivaroxaban-tablet-10mg-30-bottle-ndc-50458-580-30", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v64，2026-04-06 发布", "en": "DailyMed SPL v64, published 6 Apr 2026" }, "dosageForm": { "zh": "XARELTO 利伐沙班薄膜衣片", "en": "XARELTO rivaroxaban film-coated tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 50458-580-30", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片 10 mg；30 片瓶装", "en": "10 mg per tablet; 30-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=10db92f9-2300-4a80-836b-673e1ae91610&type=img&name=Xarelto-35.jpg", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "利伐沙班", "en": "rivaroxaban" }, "value": 10, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标示量；不是个人片数、停药或换药规则", "en": "labelled amount per tablet; not an individual's tablet count, interruption or switching rule" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-20", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 30, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "浅红色", "en": "light red" }, "shape": { "zh": "圆形薄膜衣片", "en": "round film-coated tablet" }, "imprint": "10", "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_2f3781ea4c649b1e", "label": "DailyMed（NLM）：XARELTO 利伐沙班当前美国公开标签（Janssen；SPL v64，2026-04-06 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=10db92f9-2300-4a80-836b-673e1ae91610", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-xarelto-rivaroxaban-tablet-15mg-30-bottle-ndc-50458-578-30", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v64，2026-04-06 发布", "en": "DailyMed SPL v64, published 6 Apr 2026" }, "dosageForm": { "zh": "XARELTO 利伐沙班薄膜衣片", "en": "XARELTO rivaroxaban film-coated tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 50458-578-30", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片 15 mg；30 片瓶装", "en": "15 mg per tablet; 30-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=10db92f9-2300-4a80-836b-673e1ae91610&type=img&name=Xarelto-36.jpg", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "利伐沙班", "en": "rivaroxaban" }, "value": 15, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标示量；不是个人片数、停药或换药规则", "en": "labelled amount per tablet; not an individual's tablet count, interruption or switching rule" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-20", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 30, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "红色", "en": "red" }, "shape": { "zh": "圆形薄膜衣片", "en": "round film-coated tablet" }, "imprint": "15", "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_2f3781ea4c649b1e", "label": "DailyMed（NLM）：XARELTO 利伐沙班当前美国公开标签（Janssen；SPL v64，2026-04-06 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=10db92f9-2300-4a80-836b-673e1ae91610", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-xarelto-rivaroxaban-tablet-20mg-30-bottle-ndc-50458-579-30", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v64，2026-04-06 发布", "en": "DailyMed SPL v64, published 6 Apr 2026" }, "dosageForm": { "zh": "XARELTO 利伐沙班薄膜衣片", "en": "XARELTO rivaroxaban film-coated tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 50458-579-30", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片 20 mg；30 片瓶装", "en": "20 mg per tablet; 30-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=10db92f9-2300-4a80-836b-673e1ae91610&type=img&name=Xarelto-37.jpg", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "利伐沙班", "en": "rivaroxaban" }, "value": 20, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标示量；不是个人片数、停药或换药规则", "en": "labelled amount per tablet; not an individual's tablet count, interruption or switching rule" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-20", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 30, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "深红色", "en": "dark red" }, "shape": { "zh": "三角形薄膜衣片", "en": "triangular film-coated tablet" }, "imprint": "20", "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_2f3781ea4c649b1e", "label": "DailyMed（NLM）：XARELTO 利伐沙班当前美国公开标签（Janssen；SPL v64，2026-04-06 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=10db92f9-2300-4a80-836b-673e1ae91610", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-xarelto-rivaroxaban-tablet-2-5mg-60-bottle-ndc-50458-577-60", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=10db92f9-2300-4a80-836b-673e1ae91610&type=img&name=Xarelto-34.jpg", "alt": "XARELTO 利伐沙班在美国 DailyMed 当前 Janssen 标签中的 2.5 mg、NDC 50458-577-60、60 片瓶装展示面", "archiveMarket": "美国", "labelVersion": "DailyMed SPL v64（2026-04-06 发布）", "presentation": "XARELTO 利伐沙班：每片 2.5 mg，NDC 50458-577-60，60 片瓶装展示面。", "notice": "此图只对应美国 DailyMed 当前 Janssen 标签中的 XARELTO、利伐沙班 2.5 mg、NDC 50458-577-60 与 60 片瓶装。它只帮助核对品牌、通用名、每片标示量、片剂、包装数量与来源；不用于鉴定真伪，也不证明其他强度、启动包装、口服混悬液、其他包装、其他市场、当前可得性、原研身份、可替代性，或任何个人的片数、停药、漏用补救、联用或换药方案。", "source": { "id": "src_2f3781ea4c649b1e", "label": "DailyMed（NLM）：XARELTO 利伐沙班当前美国公开标签（Janssen；SPL v64，2026-04-06 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=10db92f9-2300-4a80-836b-673e1ae91610", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "XARELTO 说明书放大阅读：四种片剂包装要分别核对", "en": "XARELTO label reading: four tablet packages need separate checking" }, "summary": { "zh": "本模块以美国 DailyMed 当前 Janssen 标签为公开阅读入口，帮助核对 XARELTO 2.5 mg、60 片瓶装，以及 10 mg、15 mg、20 mg 各 30 片瓶装的身份文字，并提出安全问题；它不决定个人应服几片、是否换药或何时停药。", "en": "This module uses the current U.S. DailyMed Janssen label as a public reading entry point, helping readers check the XARELTO 2.5 mg 60-tablet bottle and the 10 mg, 15 mg and 20 mg 30-tablet bottles and ask safer questions; it does not decide a personal tablet count, switch or stopping time." }, "checks": [ { "zh": "先同时核对 XARELTO、通用名利伐沙班（rivaroxaban）、每片强度、口服片剂、NDC、包装数量和目标市场。2.5 mg／60 片瓶装与 10 mg、15 mg、20 mg／各 30 片瓶装是不同标签身份；这些数字均不能单独说明个人的疾病、疗程、每天用法或是否可与其他药交换。", "en": "Check XARELTO, the generic name rivaroxaban, per-tablet strength, oral-tablet form, NDC, package count and target market together. The 2.5 mg/60-tablet bottle and the 10 mg, 15 mg and 20 mg/30-tablet bottles are distinct label identities; none of these numbers establishes a person's condition, course, daily use or interchangeability with another medicine." }, { "zh": "抗凝相关药物不能只因“同为防血栓”就自行互换、叠加、漏服后补量或短暂停用。若考虑换药、忘服、发生不适或需要操作，应联系开方团队或药师并带上完整药品清单。", "en": "Anticoagulant-related medicines must not be self-switched, combined, made up after a missed dose or temporarily stopped merely because they are all described as preventing clots. For a switch, missed use, symptoms or a procedure, contact the prescribing team or pharmacist with the complete medicine list." }, { "zh": "止痛抗炎药、抗血小板或其他影响凝血的产品，以及新开的处方药、非处方药、保健品和草本都需要一起核对。不要把网页上的一个相互作用提示当作自行开始或停用任何药的指令。", "en": "Anti-inflammatory pain medicines, antiplatelet or other clotting-related products, and any newly added prescription, OTC, supplement or herb all need joint review. Do not treat one interaction note on a webpage as an instruction to start or stop any medicine." }, { "zh": "外观与标签图只服务于来源核对。不同规格、市场、包装形式或标签版本可能不同；图片不能鉴定真伪、确认当前标签，或替代发生出血、手术前后等场景的医疗指示。", "en": "Appearance and label images serve source checking only. Strength, market, packaging form and label version can differ; an image cannot authenticate a product, confirm a current label or replace clinical instructions around bleeding or procedures." } ], "source": { "id": "src_2f3781ea4c649b1e", "label": "DailyMed（NLM）：XARELTO 利伐沙班当前美国公开标签（Janssen；SPL v64，2026-04-06 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=10db92f9-2300-4a80-836b-673e1ae91610", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "利伐沙班怎样起作用：它选择性抑制凝血因子 Xa", "en": "How rivaroxaban works: it selectively inhibits coagulation factor Xa" }, "summary": { "zh": "FDA 公开标签说明利伐沙班选择性抑制游离凝血因子 Xa 和凝血酶原酶活性，从而降低凝血酶生成；它对血小板聚集没有直接作用。这用于解释机制，不推导个人的片数、是否叠加另一种抗凝/抗血小板药、何时停用或是否可换药。", "en": "The FDA public label explains that rivaroxaban selectively inhibits free factor Xa and prothrombinase activity, reducing thrombin generation; it has no direct effect on platelet aggregation. This explains a mechanism, not an individual's tablet count, whether to add another anticoagulant or antiplatelet medicine, when to interrupt, or whether a switch is appropriate." }, "checks": [ { "zh": "与阿哌沙班同属因子 Xa 抑制剂，并不代表可以同时服用、互相替换或按相同时间、强度使用。具体药物、适用情形、强度、肾肝功能和现行处方必须逐项核对。", "en": "Being in the same factor Xa inhibitor class as apixaban does not mean the medicines may be taken together, swapped or used at the same time or strength. The specific medicine, use context, strength, kidney and liver function, and current prescription must each be checked." }, { "zh": "机制不能替代对出血、血栓、手术或漏服问题的个体处理。出现异常出血、计划侵入性操作、忘服或需要换药时，应联系开方团队或药师，而不是从共同机制推导做法。", "en": "Mechanism cannot replace individual handling of bleeding, thrombosis, surgery or missed-use questions. With unusual bleeding, a planned invasive procedure, missed use or a need to change medicines, contact the prescribing team or pharmacist rather than deriving action from a shared mechanism." }, { "zh": "与止痛抗炎药、抗血小板药、其他抗凝药及新开的处方药、非处方药、草本或保健品的关系，必须结合完整药单复核；本页不是个人“能否同服”清单。", "en": "Relationships with anti-inflammatory pain medicines, antiplatelet medicines, other anticoagulants and new prescription, OTC, herbal or supplement products must be reviewed with the complete medicine list; this page is not a personal “can these be taken together” list." } ], "source": { "id": "src_95f93bba8f699c06", "label": "FDA：XARELTO 2021-09 美国标签档案（临床药理）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/202439_S035_022406S037lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "Xarelto", "generic": "利伐沙班", "dosageFormClass": "本页精确展示四种 XARELTO 利伐沙班口服薄膜衣片瓶装身份；启动包装与口服混悬液不并入这些片剂包装" }, "labelSource": { "id": "src_2f3781ea4c649b1e", "label": "DailyMed（NLM）：XARELTO 利伐沙班当前美国公开标签（Janssen；SPL v64，2026-04-06 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=10db92f9-2300-4a80-836b-673e1ae91610", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "productRoutes": [ { "source": { "id": "src_2f3781ea4c649b1e", "label": "DailyMed（NLM）：XARELTO 利伐沙班当前美国公开标签（Janssen；SPL v64，2026-04-06 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=10db92f9-2300-4a80-836b-673e1ae91610", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_95f93bba8f699c06", "label": "FDA：XARELTO 2021-09 美国标签档案（NDA 202439）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/202439_S035_022406S037lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "DailyMed 当前 Janssen XARELTO 标签同时涵盖片剂、启动包装和口服混悬液。本页分别建立四个可逐项核对的美国片剂包装面板：2.5 mg、60 片瓶装；10 mg、15 mg、20 mg 各 30 片瓶装。它帮助核对品牌、通用名、剂型、每片标示量、包装和来源；不把这些面板外推为启动包装、口服混悬液、其他市场、供应或个人使用方案。", "history": "FDA 历史文件仍保留为阅读线索；外观与包装身份改以 DailyMed 当前 Janssen 原品牌标签为准。不同剂型、强度、启动包装或市场的 XARELTO 产品不能仅按名称或毫克数互相换算、替代或合并。", "sourceDocuments": [ { "id": "src_95f93bba8f699c06", "label": "FDA：XARELTO 2021-09 美国标签档案（NDA 202439）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/202439_S035_022406S037lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_2f3781ea4c649b1e", "label": "DailyMed（NLM）：XARELTO 利伐沙班当前美国公开标签（Janssen；SPL v64，2026-04-06 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=10db92f9-2300-4a80-836b-673e1ae91610", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_5ed30b676fbb9773", "label": "FDA Drugs@FDA 官方检索入口", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_lookup_entry", "documentKind": "regulatory_lookup", "market": "US", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } ], "applicationNumber": "NDA 202439", "approvalTimeline": [ { "date": "2011", "title": { "zh": "FDA 标签所列美国初始批准年份", "en": "Initial U.S. approval year listed in the FDA label" }, "detail": { "zh": "本页链接的 FDA 标签档案列示 Initial U.S. Approval: 2011。该历史定位不等同于当前批准、可得性、持有人或其他市场状态。", "en": "The FDA label archive linked here lists Initial U.S. Approval: 2011. This historical locator is not a conclusion about current approval, availability, holder or another market." }, "source": { "id": "src_95f93bba8f699c06", "label": "FDA: XARELTO label archive", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/202439_S035_022406S037lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, { "date": "2021-09", "title": { "zh": "FDA 标签档案版本", "en": "FDA label archive version" }, "detail": { "zh": "本页链接 2021-09 的 FDA 标签档案作为可复核阅读入口。现行标签、规格、适应症和安全信息必须另行以目标市场当前文件核对。", "en": "This page links the 2021-09 FDA label archive as a traceable reading entry point. Current labeling, strength, indication and safety information require separate verification against the target market’s current document." }, "source": { "id": "src_95f93bba8f699c06", "label": "FDA: XARELTO label archive", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/202439_S035_022406S037lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "已链接公开标签档案", "en": "Public label archive linked" }, "detail": { "zh": "仅对应本页所列 FDA 文件。", "en": "Only the FDA document listed on this page is linked." } }, { "market": { "zh": "中国大陆、欧盟、日本", "en": "Mainland China, EU, Japan" }, "status": { "zh": "待逐项建立市场记录", "en": "Market record not established" }, "detail": { "zh": "不从美国标签档案推定当地批准、持有人、规格、供应或可售资格。", "en": "No local approval, holder, strength, supply or sale-eligibility conclusion is inferred from the U.S. label archive." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "标签档案能代表现在的产品信息吗？", "en": "Does a label archive represent current product information?" }, "answer": { "zh": "不能自动代表。档案用于定位来源；需要以目标市场的现行官方标签逐项复核。", "en": "Not automatically. The archive locates a source; each point needs verification against the target market’s current official label." } }, { "question": { "zh": "为什么这里不展示价格或原研/仿制结论？", "en": "Why are price and originator/generic conclusions not shown?" }, "answer": { "zh": "这些结论需要产品、剂型、规格、包装、市场、日期和原始记录分别齐全并经人工审核；单一标签文件不足以支持。", "en": "Those conclusions require separately complete and human-reviewed product, dosage-form, strength, pack, market, date and primary-record fields; one label file is insufficient." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "how-to-read-a-drug-label", "regulatory-sources-first" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/xarelto/", "en": "https://origindrug.com/en/drugs/xarelto/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "brilinta", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-23", "status": "published_traceable_archive" }, "names": { "brand": "Brilinta", "generic": "替格瑞洛", "aliases": [ "ticagrelor" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "心血管", "sourceArchiveMarket": "美国有日期公开标签（SPL v56，2026-08-07 发布；本档案仅展示两个准确 60 片瓶装面板）", "dosageFormClass": "替格瑞洛口服薄膜衣片：60 mg、90 mg（DailyMed SPL v56 所列；分别展示对应的 60 片瓶装面板）", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "2011（FDA 标签所列美国初始批准）", "archiveSponsorText": "AstraZeneca Pharmaceuticals LP / DailyMed（NLM）公开标签" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-brilinta-ticagrelor-tablet-60mg-60-bottle-0186-0776-60", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v56（2026-08-07 发布）", "en": "DailyMed SPL v56 (published 7 Aug 2026)" }, "dosageForm": { "zh": "替格瑞洛口服薄膜衣片", "en": "ticagrelor film-coated oral tablet" }, "route": { "zh": "口服（仅作标签产品身份字段）", "en": "oral (label product-identity field only)" }, "routeCodes": [ "oral" ], "productCode": "NDC 0186-0776-60", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片 60 mg；60 片瓶装", "en": "60 mg per tablet; 60-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=f7b3f443-e83d-4bf2-0e96-023448fed9a8&name=60_mg_label.jpg", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "替格瑞洛", "en": "ticagrelor" }, "value": 60, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、停用、联用或换药规则", "en": "labelled amount per tablet; not an individual's tablet count, stopping, combination or switching rule" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "60 片瓶装", "en": "60-tablet bottle" }, "fill": null, "countPerPackage": 60, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-23", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 60, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "粉红色", "en": "pink" }, "shape": { "zh": "圆形双凸薄膜衣片，约 8 mm；无刻痕，不是自行掰开指示", "en": "round biconvex film-coated tablet, about 8 mm; unscored, not a self-splitting instruction" }, "imprint": { "zh": "60 在 T 上方", "en": "60 over T" }, "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_80f1939211d8c0ae", "label": "DailyMed（NLM）：BRILINTA 替格瑞洛 60 mg、60 片瓶装美国公开标签面板（AstraZeneca；SPL v56，2026-08-07 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=f7b3f443-e83d-4bf2-0e96-023448fed9a8", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-brilinta-ticagrelor-tablet-90mg-60-bottle-0186-0777-60", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v56（2026-08-07 发布）", "en": "DailyMed SPL v56 (published 7 Aug 2026)" }, "dosageForm": { "zh": "替格瑞洛口服薄膜衣片", "en": "ticagrelor film-coated oral tablet" }, "route": { "zh": "口服（仅作标签产品身份字段）", "en": "oral (label product-identity field only)" }, "routeCodes": [ "oral" ], "productCode": "NDC 0186-0777-60", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片 90 mg；60 片瓶装", "en": "90 mg per tablet; 60-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=f7b3f443-e83d-4bf2-0e96-023448fed9a8&name=90_mg_label.jpg", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "替格瑞洛", "en": "ticagrelor" }, "value": 90, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、停用、联用或换药规则", "en": "labelled amount per tablet; not an individual's tablet count, stopping, combination or switching rule" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "60 片瓶装", "en": "60-tablet bottle" }, "fill": null, "countPerPackage": 60, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-23", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 60, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "黄色", "en": "yellow" }, "shape": { "zh": "圆形双凸薄膜衣片，约 9 mm；无刻痕，不是自行掰开指示", "en": "round biconvex film-coated tablet, about 9 mm; unscored, not a self-splitting instruction" }, "imprint": { "zh": "90 在 T 上方", "en": "90 over T" }, "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_80f1939211d8c0ae", "label": "DailyMed（NLM）：BRILINTA 替格瑞洛 90 mg、60 片瓶装美国公开标签面板（AstraZeneca；SPL v56，2026-08-07 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=f7b3f443-e83d-4bf2-0e96-023448fed9a8", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-brilinta-ticagrelor-tablet-90mg-60-bottle-0186-0777-60", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=f7b3f443-e83d-4bf2-0e96-023448fed9a8&name=90_mg_label.jpg", "alt": "BRILINTA 90 mg 片剂在美国 DailyMed 公开标签中的瓶装主展示面", "archiveMarket": "美国", "labelVersion": "2026-08", "presentation": "BRILINTA 90 mg 片剂瓶装主展示面（DailyMed 2026-08 公开标签所列）。", "notice": "此为美国 DailyMed 公开标签中的 BRILINTA 包装文字图，只帮助核对品牌、通用名、强度、剂型和来源；不用于鉴定真伪，也不证明原研身份、当前包装、目标市场批准或可售资格。", "source": { "id": "src_80f1939211d8c0ae", "label": "DailyMed（NLM）：BRILINTA 替格瑞洛美国公开标签（AstraZeneca；SPL v56，2026-08-07 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=f7b3f443-e83d-4bf2-0e96-023448fed9a8", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "BRILINTA 说明书放大阅读：包装上的 60 mg／90 mg 先是身份线索，不是个人用药指令", "en": "BRILINTA label reading: 60 mg/90 mg on a pack are identity clues first, not personal-use instructions" }, "summary": { "zh": "本模块以 DailyMed SPL v56 美国公开标签为阅读入口，帮助核对 BRILINTA、替格瑞洛、准确片剂、每片标示强度、60 片瓶装和目标市场；它不提供个人片数、漏用处理、停用、与阿司匹林/抗凝药联用或围手术期安排。", "en": "This module uses the DailyMed SPL v56 U.S. public label as a reading entry point. It helps check BRILINTA, ticagrelor, the exact tablet, labelled strength per tablet, 60-tablet bottle and target market; it does not provide an individual's tablet count, missed-use handling, stopping, aspirin/anticoagulant combination or peri-procedure plan." }, "checks": [ { "zh": "先把 BRILINTA、替格瑞洛、60 mg 或 90 mg、NDC、60 片瓶装和目标市场一起核对。mg 是每片标签标示量；同一品牌、相近颜色或“都是防血栓”都不能把另一种片剂、包装或市场产品视为可以自行转换。", "en": "Check BRILINTA, ticagrelor, 60 mg or 90 mg, NDC, 60-tablet bottle and target market together. mg is the labelled amount per tablet; the same brand, a similar colour or being described as clot prevention does not make another tablet, pack or market product self-convertible." }, { "zh": "标签涉及出血风险、阿司匹林、其他抗血小板/抗凝产品、手术或牙科操作及多种相互作用时的专业判断。不要仅根据家中药盒、网络经验或一次不适改变任何一种产品的用量、频率、组合、暂停或恢复。", "en": "The label involves professional judgement around bleeding risk, aspirin, other antiplatelet/anticoagulant products, surgery or dental procedures and multiple interactions. Do not change the amount, frequency, combination, pause or restart of any product based only on packs at home, online anecdotes or one symptom." }, { "zh": "该准确美国标签包含对特定片剂处理方式的产品专属文字；这不是对任何人、任何包装、任何市场或任何其他片剂的自行掰开、研碎、转换或改量授权。需要处理困难、药物转换或不确定如何使用时，应带实际包装和完整药单请药师或开方团队核对。", "en": "This exact U.S. label contains product-specific wording for handling certain tablets; it is not permission for anyone to self-split, crush, convert or change amounts for any pack, market or other tablet. With handling difficulty, a medicine transition or uncertainty about use, have a pharmacist or prescribing team review the actual pack and complete medicine list." }, { "zh": "出现明显或不明原因出血、黑便、咳血/呕血、头部受伤、突发胸痛、呼吸困难或神经系统症状时，应使用当地紧急和医疗渠道；不要从本页推断继续、暂停或补用。", "en": "With significant or unexplained bleeding, black stools, coughing/vomiting blood, head injury, sudden chest pain, breathing trouble or neurological symptoms, use local urgent and medical pathways; do not infer continuation, pause or make-up use from this page." } ], "source": { "id": "src_80f1939211d8c0ae", "label": "DailyMed（NLM）：BRILINTA 替格瑞洛美国公开标签（AstraZeneca；SPL v56，2026-08-07 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=f7b3f443-e83d-4bf2-0e96-023448fed9a8", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "替格瑞洛怎样起作用：标签描述其可逆性影响血小板 P2Y12 受体", "en": "How ticagrelor works: the label describes reversible action at the platelet P2Y12 receptor" }, "summary": { "zh": "标签将替格瑞洛描述为可逆性结合血小板 P2Y12 ADP 受体的口服拮抗剂，并以此抑制血小板活化和聚集。这解释药理通路，不判断任何个人的血栓或出血风险、是否适用、何时停用或怎样与其他抗栓药合用。", "en": "The label describes ticagrelor as an oral antagonist that reversibly binds the platelet P2Y12 ADP receptor, thereby inhibiting platelet activation and aggregation. This explains a pharmacologic pathway, not an individual's clot or bleeding risk, suitability, stopping time or use with another antithrombotic medicine." }, "checks": [ { "zh": "“影响血小板”不表示每一种抗凝、抗血小板或止痛产品都可以自行相加、相换或隔天轮用。产品类别、适用情形、手术计划和完整药单必须一并由专业人员核对。", "en": "“Affecting platelets” does not make every anticoagulant, antiplatelet or pain product self-addable, interchangeable or suitable for alternation. Product class, context, procedure plans and the complete medicine list must be reviewed together by a professional." }, { "zh": "可逆性是机制描述，不是“感觉出血就可自行停”的指令。是否暂停、何时恢复或如何处理漏用，都取决于准确产品、原因、风险和开方团队的安排。", "en": "Reversibility is a mechanism description, not an instruction to self-stop when bleeding is feared. Whether to pause, when to restart or how to handle a missed use depends on the exact product, reason, risks and plan from the prescribing team." }, { "zh": "机制也不能预测一个人是否会出血、胸闷或需要联用阿司匹林。出现急性症状、意外受伤或计划操作时，应使用当地医疗渠道，而不是从本页推导处理方案。", "en": "Mechanism also cannot predict whether a person will bleed, have chest symptoms or need aspirin in combination. With acute symptoms, accidental injury or a planned procedure, use local medical pathways rather than derive a plan from this page." } ], "source": { "id": "src_80f1939211d8c0ae", "label": "DailyMed（NLM）：BRILINTA 替格瑞洛美国公开标签（AstraZeneca；SPL v56，2026-08-07 发布；Clinical Pharmacology）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=f7b3f443-e83d-4bf2-0e96-023448fed9a8", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "Brilinta", "generic": "替格瑞洛", "dosageFormClass": "替格瑞洛口服薄膜衣片：60 mg、90 mg（DailyMed SPL v56 所列；分别展示对应的 60 片瓶装面板）" }, "labelSource": { "id": "src_80f1939211d8c0ae", "label": "DailyMed（NLM）：BRILINTA 替格瑞洛美国公开标签（AstraZeneca；SPL v56，2026-08-07 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=f7b3f443-e83d-4bf2-0e96-023448fed9a8", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "productRoutes": [ { "source": { "id": "src_80f1939211d8c0ae", "label": "DailyMed（NLM）：BRILINTA 替格瑞洛美国公开标签（AstraZeneca；SPL v56，2026-08-07 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=f7b3f443-e83d-4bf2-0e96-023448fed9a8", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-23", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_9b04044fd9cab5eb", "label": "FDA：BRILINTA 2020 美国标签档案（NDA 022433）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022433s030lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-23", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "DailyMed 的 AstraZeneca BRILINTA（ticagrelor）有日期美国公开标签列有 60 mg、90 mg 口服薄膜衣片。本页分别建立两个准确 60 片瓶装面板的品牌、通用名、每片强度、NDC、外观线索和来源核对卡；不把包装数字变成个人片数、停用、联用、转换或购买结论。", "history": "这两张包装面板只对应 DailyMed SPL v56 所列的 BRILINTA 60 mg（NDC 0186-0776-60）和 90 mg（NDC 0186-0777-60）、各 60 片瓶装。相同名称、通用名、颜色或 mg 数字不足以确认完整产品身份；须按目标市场、剂型、规格、包装及现行标签逐项核验。", "sourceDocuments": [ { "id": "src_80f1939211d8c0ae", "label": "DailyMed（NLM）：BRILINTA 替格瑞洛美国公开标签（AstraZeneca；SPL v56，2026-08-07 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=f7b3f443-e83d-4bf2-0e96-023448fed9a8", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, { "id": "src_9b04044fd9cab5eb", "label": "FDA：BRILINTA 2020 美国标签档案（NDA 022433）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022433s030lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_5ed30b676fbb9773", "label": "FDA Drugs@FDA 官方检索入口", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_lookup_entry", "documentKind": "regulatory_lookup", "market": "US", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } ], "applicationNumber": "NDA 022433", "approvalTimeline": [ { "date": "2011", "title": { "zh": "FDA 标签所列美国初始批准年份", "en": "Initial U.S. approval year listed in the FDA label" }, "detail": { "zh": "本页链接的 FDA 标签档案列示 Initial U.S. Approval: 2011。该历史定位不等同于当前批准、可得性、持有人或其他市场状态。", "en": "The FDA label archive linked here lists Initial U.S. Approval: 2011. This historical locator is not a conclusion about current approval, availability, holder or another market." }, "source": { "id": "src_9b04044fd9cab5eb", "label": "FDA: BRILINTA label archive", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022433s030lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, { "date": "2020", "title": { "zh": "FDA 标签档案版本", "en": "FDA label archive version" }, "detail": { "zh": "本页链接 2020 的 FDA 标签档案作为可复核阅读入口。现行标签、规格、适应症和安全信息必须另行以目标市场当前文件核对。", "en": "This page links the 2020 FDA label archive as a traceable reading entry point. Current labeling, strength, indication and safety information require separate verification against the target market’s current document." }, "source": { "id": "src_9b04044fd9cab5eb", "label": "FDA: BRILINTA label archive", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022433s030lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "已链接公开标签档案", "en": "Public label archive linked" }, "detail": { "zh": "仅对应本页所列 FDA 文件。", "en": "Only the FDA document listed on this page is linked." } }, { "market": { "zh": "中国大陆、欧盟、日本", "en": "Mainland China, EU, Japan" }, "status": { "zh": "待逐项建立市场记录", "en": "Market record not established" }, "detail": { "zh": "不从美国标签档案推定当地批准、持有人、规格、供应或可售资格。", "en": "No local approval, holder, strength, supply or sale-eligibility conclusion is inferred from the U.S. label archive." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "标签档案能代表现在的产品信息吗？", "en": "Does a label archive represent current product information?" }, "answer": { "zh": "不能自动代表。档案用于定位来源；需要以目标市场的现行官方标签逐项复核。", "en": "Not automatically. The archive locates a source; each point needs verification against the target market’s current official label." } }, { "question": { "zh": "为什么这里不展示价格或原研/仿制结论？", "en": "Why are price and originator/generic conclusions not shown?" }, "answer": { "zh": "这些结论需要产品、剂型、规格、包装、市场、日期和原始记录分别齐全并经人工审核；单一标签文件不足以支持。", "en": "Those conclusions require separately complete and human-reviewed product, dosage-form, strength, pack, market, date and primary-record fields; one label file is insufficient." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "how-to-read-a-drug-label", "regulatory-sources-first" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/brilinta/", "en": "https://origindrug.com/en/drugs/brilinta/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "lasix", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-17", "status": "published_traceable_archive" }, "names": { "brand": "Lasix", "generic": "呋塞米", "aliases": [ "furosemide" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "心血管", "sourceArchiveMarket": "美国公开监管标签档案", "dosageFormClass": "口服片剂（FDA 2018 标签档案及 DailyMed 2025-10 公开标签所列）", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "美国初始批准年份待逐项核验", "archiveSponsorText": "FDA / DailyMed 公开监管标签档案" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-lasix-furosemide-tablet-20mg-100-count-bottle-ndc-30698-067-01", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v7，2025-10-02 发布；页面 2025-09-30 更新", "en": "DailyMed SPL v7, published 2 Oct 2025; page updated 30 Sep 2025" }, "dosageForm": { "zh": "口服片", "en": "oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 30698-067-01", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片呋塞米 20 mg；100 片瓶装", "en": "Furosemide 20 mg per tablet; 100-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=2c9b4d8f-0770-482d-a9e6-9c616a440b1a&name=lasix-02.jpg", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "呋塞米", "en": "furosemide" }, "value": 20, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标示量；不是个人片数、补用、分片或换药规则", "en": "labelled amount per tablet; not an individual tablet-count, make-up, splitting or switching rule" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": null, "package": { "count": 100, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "白色", "en": "white" }, "shape": { "zh": "椭圆片", "en": "oval tablet" }, "imprint": "Lasix®", "scoreStatus": "not_scored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_c20f5a5ac5e3b01e", "label": "DailyMed（NLM）：LASIX 呋塞米片当前美国公开标签（Validus；页面 2025-09-30 更新，SPL v7 于 2025-10-02 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=2c9b4d8f-0770-482d-a9e6-9c616a440b1a", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-lasix-furosemide-tablet-40mg-100-count-bottle-ndc-30698-060-01", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v7，2025-10-02 发布；页面 2025-09-30 更新", "en": "DailyMed SPL v7, published 2 Oct 2025; page updated 30 Sep 2025" }, "dosageForm": { "zh": "口服片", "en": "oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 30698-060-01", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片呋塞米 40 mg；100 片瓶装", "en": "Furosemide 40 mg per tablet; 100-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=2c9b4d8f-0770-482d-a9e6-9c616a440b1a&name=lasix-03.jpg", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "呋塞米", "en": "furosemide" }, "value": 40, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标示量；不是个人片数、补用、分片或换药规则", "en": "labelled amount per tablet; not an individual tablet-count, make-up, splitting or switching rule" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": null, "package": { "count": 100, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "白色", "en": "white" }, "shape": { "zh": "圆片", "en": "round tablet" }, "imprint": "Lasix® 40", "scoreStatus": "scored_status_not_a_split_instruction", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_c20f5a5ac5e3b01e", "label": "DailyMed（NLM）：LASIX 呋塞米片当前美国公开标签（Validus；页面 2025-09-30 更新，SPL v7 于 2025-10-02 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=2c9b4d8f-0770-482d-a9e6-9c616a440b1a", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-lasix-furosemide-tablet-80mg-50-count-bottle-ndc-30698-066-05", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v7，2025-10-02 发布；页面 2025-09-30 更新", "en": "DailyMed SPL v7, published 2 Oct 2025; page updated 30 Sep 2025" }, "dosageForm": { "zh": "口服片", "en": "oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 30698-066-05", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片呋塞米 80 mg；50 片瓶装", "en": "Furosemide 80 mg per tablet; 50-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=2c9b4d8f-0770-482d-a9e6-9c616a440b1a&name=lasix-04.jpg", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "呋塞米", "en": "furosemide" }, "value": 80, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标示量；不是个人片数、补用、分片或换药规则", "en": "labelled amount per tablet; not an individual tablet-count, make-up, splitting or switching rule" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 50, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": null, "package": { "count": 50, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "白色", "en": "white" }, "shape": { "zh": "圆形有斜边片", "en": "facetted-edge round tablet" }, "imprint": "Lasix® 80", "scoreStatus": "scored_status_not_a_split_instruction", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_c20f5a5ac5e3b01e", "label": "DailyMed（NLM）：LASIX 呋塞米片当前美国公开标签（Validus；页面 2025-09-30 更新，SPL v7 于 2025-10-02 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=2c9b4d8f-0770-482d-a9e6-9c616a440b1a", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": null, "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=2c9b4d8f-0770-482d-a9e6-9c616a440b1a&name=lasix-03.jpg", "alt": "LASIX 40 mg 片剂在美国 DailyMed 公开标签中的瓶装主展示面", "archiveMarket": "美国", "labelVersion": "2025-10", "presentation": "LASIX 40 mg 口服片剂瓶装主展示面（DailyMed 2025-10 公开标签所列）。", "notice": "此为美国 DailyMed 公开标签中的 LASIX 包装文字图，只帮助核对品牌、通用名、强度、剂型和来源；不用于鉴定真伪，也不证明原研身份、当前包装、目标市场批准或可售资格。", "source": { "id": "src_c20f5a5ac5e3b01e", "label": "DailyMed（NLM）：LASIX 呋塞米片当前美国公开标签（Validus；页面 2025-09-30 更新，SPL v7 于 2025-10-02 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=2c9b4d8f-0770-482d-a9e6-9c616a440b1a", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "LASIX 说明书放大阅读：20、40、80 mg 是三种片剂强度，不是自行增减的规则", "en": "LASIX label reading: 20, 40 and 80 mg identify tablet strengths, not a rule for self-adjustment" }, "summary": { "zh": "本模块以 FDA 2018 历史标签与 DailyMed 2025-10 公开标签为阅读入口，帮助核对 LASIX、呋塞米、口服片剂及不同 mg 包装文字；它不把药盒数字转换为个人片数、加减量、补服或停药方案。", "en": "This module uses the 2018 FDA historical label and the Oct 2025 DailyMed public label as reading entry points for LASIX, furosemide, oral tablets and different mg package text; it does not turn a pack number into an individual's tablet count, dose adjustment, catch-up or stopping plan." }, "checks": [ { "zh": "公开标签列有 20、40、80 mg 口服片剂。每个数字首先描述一片的标示强度；剩余药片、体重变化、脚肿或一次尿量都不能让读者自行把不同强度拼成新的服用数量。", "en": "The public label lists 20, 40 and 80 mg oral tablets. Each number first describes the stated strength of one tablet; remaining tablets, weight change, ankle swelling or one episode of urine output do not allow a reader to assemble different strengths into a new personal tablet count." }, { "zh": "该标签把水和电解质变化、低血压、肾功能及与其他药物相关的情况列为需要专业复核的内容。高龄、多药并用、饮水/进食改变、近期腹泻呕吐或检查前后时，尤其应使用完整药单和实际包装请医生或药师核对，而不是按包装颜色或“利尿”字样自调。", "en": "The label identifies changes in fluid and electrolytes, hypotension, kidney function and medicine-related issues as matters for professional review. With older age, multiple medicines, changed intake, recent vomiting or diarrhoea, or around testing and procedures, use the complete medicine list and actual package for clinician or pharmacist review rather than self-adjusting from pack colour or the word “diuretic.”" }, { "zh": "LASIX 与其他“降压药”“利尿药”或补充剂名称相似、用途重叠，都不能自动说明可以合用、轮换或互相替代。是否存在重复、相互作用或需要实验室监测，必须由开方团队结合具体产品与个人资料确认。", "en": "A name or overlapping purpose with another “blood-pressure medicine,” “diuretic” or supplement does not automatically establish that products can be combined, alternated or substituted. Duplication, interactions and a need for laboratory monitoring must be confirmed by the prescribing team using the exact products and individual information." }, { "zh": "包装外观、40 mg 标示或瓶装数量仅用于定位来源，不能鉴定真伪，也不能证明当前市场批准或决定个人用药。出现晕厥、明显虚弱、意识改变、严重不适或不确定怎样服用时，应按当地紧急医疗与专业联系渠道处理。", "en": "Package appearance, a 40 mg marking or bottle count only help locate a source. They cannot authenticate a medicine, establish current market approval or determine individual use. With fainting, marked weakness, altered awareness, severe illness or uncertainty about use, use local urgent-care and professional contact pathways." } ], "source": { "id": "src_c20f5a5ac5e3b01e", "label": "DailyMed（NLM）：LASIX 公开标签（2025-10）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=2c9b4d8f-0770-482d-a9e6-9c616a440b1a", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "呋塞米怎样起作用：它影响肾脏小管对钠和氯的重吸收", "en": "How furosemide works: it affects renal-tubule reabsorption of sodium and chloride" }, "summary": { "zh": "FDA 的 LASIX 标签在临床药理部分描述：呋塞米主要抑制肾脏近端、远端小管及亨利袢对钠和氯的重吸收。它帮助理解为何标签会强调水分和电解质；但它不提供个人的喝水量、片数、服用时间、加减量或停药答案。", "en": "In Clinical Pharmacology, the FDA LASIX label describes furosemide as primarily inhibiting sodium and chloride reabsorption in the proximal and distal tubules and the loop of Henle. It helps explain why the label emphasises fluid and electrolytes; it does not provide an individual's fluid intake, tablet count, timing, dose-change or stopping answer." }, "checks": [ { "zh": "可把“重吸收”理解为肾脏把一部分物质从尿液形成过程中收回体内的步骤。机制说明能帮助读懂“利尿”和电解质警示，但不能根据一次尿量、脚肿、体重或血压读数自行决定多服、少服或漏服后补服。", "en": "“Reabsorption” can be read as a step in which the kidneys take some substances back into the body during urine formation. The mechanism helps read “diuretic” and electrolyte warnings, but cannot turn one episode of urine output, ankle swelling, weight or a blood-pressure reading into a self-directed increase, decrease or catch-up dose." }, { "zh": "同样影响水分、血压或肾功能的药物并不一定可安全合用或轮换。机制相近只能提示“需要核对”，不能替代医生或药师针对全部处方药、非处方药、补充剂、检验结果和实际包装的复核。", "en": "Medicines that also affect fluid, blood pressure or kidney function are not necessarily safe to combine or alternate. A related mechanism only signals “needs review”; it cannot replace clinician or pharmacist review of all prescriptions, OTC products, supplements, test results and actual packages." }, { "zh": "LASIX 的 20、40、80 mg 片剂强度与该机制是两个不同层面：前者用于识别每片标示量，后者解释作用路径。两者放在一起仍不能得出个人剂量或任何“哪种强度更适合我”的结论。", "en": "LASIX 20, 40 and 80 mg tablet strengths and its mechanism are different layers: the former identify stated amount per tablet, while the latter explains a pathway. Taken together, they still cannot determine an individual dose or which strength is “best for me.”" } ], "source": { "id": "src_71170213aebe19af", "label": "FDA：LASIX 2018 处方信息（Clinical Pharmacology）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/016273s069lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "Lasix", "generic": "呋塞米", "dosageFormClass": "口服片剂（FDA 2018 标签档案及 DailyMed 2025-10 公开标签所列）" }, "labelSource": { "id": "src_c20f5a5ac5e3b01e", "label": "DailyMed（NLM）：LASIX 公开标签（2025-10）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=2c9b4d8f-0770-482d-a9e6-9c616a440b1a", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "productRoutes": [ { "source": { "id": "src_c20f5a5ac5e3b01e", "label": "DailyMed（NLM）：LASIX 公开标签（2025-10）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=2c9b4d8f-0770-482d-a9e6-9c616a440b1a", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_71170213aebe19af", "label": "FDA：LASIX 2018 美国标签（NDA 016273）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/016273s069lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "FDA 的 LASIX（furosemide）2018 美国标签档案列示 20、40、80 mg 口服片剂。DailyMed 2025-10 美国公开标签保留了该口服片剂的包装展示面。此处仅提供可复核的美国文件与产品身份阅读入口，不推定其他市场的批准、规格、持有人、原研关系、供应或可售资格。", "history": "FDA 历史标签与 DailyMed 公开标签用于定位本页所列的美国文件和口服剂型；它们不是现行目标市场标签或个人用药结论。目标市场的现行标签、规格、风险信息和个体用药均须另行核验。", "sourceDocuments": [ { "id": "src_71170213aebe19af", "label": "FDA：LASIX 2018 美国标签（NDA 016273）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/016273s069lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_c20f5a5ac5e3b01e", "label": "DailyMed（NLM）：LASIX 公开标签（2025-10）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=2c9b4d8f-0770-482d-a9e6-9c616a440b1a", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_5ed30b676fbb9773", "label": "FDA Drugs@FDA 官方检索入口", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_lookup_entry", "documentKind": "regulatory_lookup", "market": "US", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } ], "applicationNumber": "NDA 016273", "approvalTimeline": [ { "date": "2018-08", "title": { "zh": "FDA 标签档案版本", "en": "FDA label archive version" }, "detail": { "zh": "本页链接 2018-08 的 FDA 标签档案作为可复核阅读入口。现行标签、规格、适应症和安全信息必须另行以目标市场当前文件核对。", "en": "This page links the 2018-08 FDA label archive as a traceable reading entry point. Current labeling, strength, indication and safety information require separate verification against the target market’s current document." }, "source": { "id": "src_71170213aebe19af", "label": "FDA: LASIX label archive", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/016273s069lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "已链接公开标签档案", "en": "Public label archive linked" }, "detail": { "zh": "仅对应本页所列 FDA 文件。", "en": "Only the FDA document listed on this page is linked." } }, { "market": { "zh": "中国大陆、欧盟、日本", "en": "Mainland China, EU, Japan" }, "status": { "zh": "待逐项建立市场记录", "en": "Market record not established" }, "detail": { "zh": "不从美国标签档案推定当地批准、持有人、规格、供应或可售资格。", "en": "No local approval, holder, strength, supply or sale-eligibility conclusion is inferred from the U.S. label archive." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "标签档案能代表现在的产品信息吗？", "en": "Does a label archive represent current product information?" }, "answer": { "zh": "不能自动代表。档案用于定位来源；需要以目标市场的现行官方标签逐项复核。", "en": "Not automatically. The archive locates a source; each point needs verification against the target market’s current official label." } }, { "question": { "zh": "为什么这里不展示价格或原研/仿制结论？", "en": "Why are price and originator/generic conclusions not shown?" }, "answer": { "zh": "这些结论需要产品、剂型、规格、包装、市场、日期和原始记录分别齐全并经人工审核；单一标签文件不足以支持。", "en": "Those conclusions require separately complete and human-reviewed product, dosage-form, strength, pack, market, date and primary-record fields; one label file is insufficient." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "how-to-read-a-drug-label", "regulatory-sources-first" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/lasix/", "en": "https://origindrug.com/en/drugs/lasix/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "coreg", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-21", "status": "published_traceable_archive" }, "names": { "brand": "Coreg", "generic": "卡维地洛", "aliases": [ "COREG", "carvedilol" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "心血管", "sourceArchiveMarket": "美国当前 COREG 卡维地洛公开标签（DailyMed 页面 2026-07-31 更新；SPL v3 于 2026-08-03 发布）", "dosageFormClass": "普通口服薄膜衣片：3.125 mg、6.25 mg、12.5 mg、25 mg；不与 COREG CR 缓释胶囊混同", "dosageFormClassCode": "oral_modified_release", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "1995（当前美国标签所列 Initial U.S. Approval）", "archiveSponsorText": "Waylis Therapeutics LLC / DailyMed（NLM）当前美国公开标签" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [ "COREG CR", "carvedilol phosphate", "extended-release", "缓释胶囊", "卡维地洛磷酸盐" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-coreg-carvedilol-tablet-3-125mg-100-count-bottle-ndc-80725-139-20", "marketCode": "US", "labelVersion": { "zh": "DailyMed 页面 2026-07-31 更新；SPL v3 于 2026-08-03 发布", "en": "DailyMed page updated 31 Jul 2026; SPL v3 published 3 Aug 2026" }, "dosageForm": { "zh": "COREG 卡维地洛普通口服薄膜衣片", "en": "COREG carvedilol immediate-release oral film-coated tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 80725-139-20", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片卡维地洛 3.125 mg；100 片瓶装", "en": "Carvedilol 3.125 mg per tablet; 100-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=07c619c6-4a0c-445e-94fa-664a54f68a39&name=coreg-06.jpg", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "卡维地洛", "en": "carvedilol" }, "value": 3.125, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标示量；不是个人片数、加减量、分片或换药规则", "en": "labelled amount per tablet; not an individual tablet-count, adjustment, splitting or switching rule" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": null, "package": { "count": 100, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "橙色标示条", "en": "orange strength band" }, "shape": { "zh": "白色椭圆形薄膜衣片", "en": "white oval film-coated tablet" }, "imprint": "39 / WP", "scoreStatus": "not_scored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_7a6d051d5bf5e431", "label": "DailyMed（NLM）：COREG 卡维地洛当前美国公开标签（Waylis Therapeutics；SPL v3，2026-08-03 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=07c619c6-4a0c-445e-94fa-664a54f68a39", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-coreg-carvedilol-tablet-6-25mg-100-count-bottle-ndc-80725-140-20", "marketCode": "US", "labelVersion": { "zh": "DailyMed 页面 2026-07-31 更新；SPL v3 于 2026-08-03 发布", "en": "DailyMed page updated 31 Jul 2026; SPL v3 published 3 Aug 2026" }, "dosageForm": { "zh": "COREG 卡维地洛普通口服薄膜衣片", "en": "COREG carvedilol immediate-release oral film-coated tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 80725-140-20", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片卡维地洛 6.25 mg；100 片瓶装", "en": "Carvedilol 6.25 mg per tablet; 100-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=07c619c6-4a0c-445e-94fa-664a54f68a39&name=coreg-07.jpg", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "卡维地洛", "en": "carvedilol" }, "value": 6.25, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标示量；不是个人片数、加减量、分片或换药规则", "en": "labelled amount per tablet; not an individual tablet-count, adjustment, splitting or switching rule" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": null, "package": { "count": 100, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "绿色标示条", "en": "green strength band" }, "shape": { "zh": "白色椭圆形薄膜衣片", "en": "white oval film-coated tablet" }, "imprint": "4140 / WP", "scoreStatus": "scored_status_not_a_split_instruction", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_7a6d051d5bf5e431", "label": "DailyMed（NLM）：COREG 卡维地洛当前美国公开标签（Waylis Therapeutics；SPL v3，2026-08-03 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=07c619c6-4a0c-445e-94fa-664a54f68a39", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-coreg-carvedilol-tablet-12-5mg-100-count-bottle-ndc-80725-141-20", "marketCode": "US", "labelVersion": { "zh": "DailyMed 页面 2026-07-31 更新；SPL v3 于 2026-08-03 发布", "en": "DailyMed page updated 31 Jul 2026; SPL v3 published 3 Aug 2026" }, "dosageForm": { "zh": "COREG 卡维地洛普通口服薄膜衣片", "en": "COREG carvedilol immediate-release oral film-coated tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 80725-141-20", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片卡维地洛 12.5 mg；100 片瓶装", "en": "Carvedilol 12.5 mg per tablet; 100-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=07c619c6-4a0c-445e-94fa-664a54f68a39&name=coreg-08.jpg", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "卡维地洛", "en": "carvedilol" }, "value": 12.5, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标示量；不是个人片数、加减量、分片或换药规则", "en": "labelled amount per tablet; not an individual tablet-count, adjustment, splitting or switching rule" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": null, "package": { "count": 100, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "红色标示条", "en": "red strength band" }, "shape": { "zh": "白色椭圆形薄膜衣片", "en": "white oval film-coated tablet" }, "imprint": "4141 / WP", "scoreStatus": "scored_status_not_a_split_instruction", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_7a6d051d5bf5e431", "label": "DailyMed（NLM）：COREG 卡维地洛当前美国公开标签（Waylis Therapeutics；SPL v3，2026-08-03 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=07c619c6-4a0c-445e-94fa-664a54f68a39", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-coreg-carvedilol-tablet-25mg-100-count-bottle-ndc-80725-142-20", "marketCode": "US", "labelVersion": { "zh": "DailyMed 页面 2026-07-31 更新；SPL v3 于 2026-08-03 发布", "en": "DailyMed page updated 31 Jul 2026; SPL v3 published 3 Aug 2026" }, "dosageForm": { "zh": "COREG 卡维地洛普通口服薄膜衣片", "en": "COREG carvedilol immediate-release oral film-coated tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 80725-142-20", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片卡维地洛 25 mg；100 片瓶装", "en": "Carvedilol 25 mg per tablet; 100-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=07c619c6-4a0c-445e-94fa-664a54f68a39&name=coreg-09.jpg", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "卡维地洛", "en": "carvedilol" }, "value": 25, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标示量；不是个人片数、加减量、分片或换药规则", "en": "labelled amount per tablet; not an individual tablet-count, adjustment, splitting or switching rule" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": null, "package": { "count": 100, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "紫色标示条", "en": "purple strength band" }, "shape": { "zh": "白色椭圆形薄膜衣片", "en": "white oval film-coated tablet" }, "imprint": "4142 / WP", "scoreStatus": "scored_status_not_a_split_instruction", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_7a6d051d5bf5e431", "label": "DailyMed（NLM）：COREG 卡维地洛当前美国公开标签（Waylis Therapeutics；SPL v3，2026-08-03 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=07c619c6-4a0c-445e-94fa-664a54f68a39", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-coreg-carvedilol-tablet-12-5mg-100-count-bottle-ndc-80725-141-20", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=07c619c6-4a0c-445e-94fa-664a54f68a39&name=coreg-08.jpg", "alt": "COREG 卡维地洛在美国 DailyMed 当前公开标签中的 12.5 mg、NDC 80725-141-20、100 片瓶装展示面", "archiveMarket": "美国", "labelVersion": "DailyMed 页面 2026-07-31 更新；SPL v3 于 2026-08-03 发布", "presentation": "COREG 卡维地洛：每片 12.5 mg，NDC 80725-141-20，100 片瓶装展示面。", "notice": "此图只对应美国 DailyMed 当前标签中的 COREG、卡维地洛 12.5 mg、NDC 80725-141-20 与 100 片瓶装。它只帮助核对品牌、通用名、每片标示量、普通口服片、包装数量与来源；不用于鉴定真伪，也不证明其他强度、COREG CR 缓释胶囊、其他包装、其他市场、实际可得性、原研身份、可替代性或任何个人的片数、掰开、停用、联用或换药方案。", "source": { "id": "src_7a6d051d5bf5e431", "label": "DailyMed（NLM）：COREG 卡维地洛当前美国公开标签（Waylis Therapeutics；SPL v3，2026-08-03 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=07c619c6-4a0c-445e-94fa-664a54f68a39", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "COREG 说明书放大阅读：四种 mg 是不同普通片剂身份，不是自行加减的阶梯", "en": "COREG label reading: four mg values identify distinct regular tablets, not a self-adjustment ladder" }, "summary": { "zh": "本模块以美国 DailyMed 当前公开标签为阅读入口，帮助核对 COREG、卡维地洛、每片 3.125/6.25/12.5/25 mg、普通口服片、准确 NDC 和 100 片瓶装。它不决定个人片数、何时开始或停用、能否掰开、何时与另一种心血管产品同用，或怎样从 COREG CR 转换。", "en": "This module uses the current U.S. DailyMed public label to check COREG, carvedilol, 3.125/6.25/12.5/25 mg per tablet, regular oral-tablet form, exact NDC and 100-tablet bottle. It does not decide an individual's tablet count, when to start or stop, whether to split, use with another cardiovascular product, or how to change from COREG CR." }, "checks": [ { "zh": "先把 COREG、卡维地洛、每片 mg、普通口服片、实际 NDC、瓶装数量和目标市场一起核对。毫克数只描述这一准确片剂每片的标示量，不是网页可以换算成个人片数、加减量或由一盒换到另一盒的规则。", "en": "Check COREG, carvedilol, mg per tablet, regular oral-tablet form, actual NDC, bottle count and target market together. Milligrams describe the labelled amount in an exact tablet, not a web rule for personal tablet count, adjustment or replacing one pack with another." }, { "zh": "COREG CR 是缓释胶囊，标签所示成分形式和剂型与本页普通片不同。不要依据同一品牌、相近数字或“每天一次/两次”的说法自行换算、叠加、错开、轮换或替换；带准确药盒和完整药单请药师或开方团队核对。", "en": "COREG CR is an extended-release capsule with a different dosage form and labelled ingredient form from the regular tablets on this page. Do not self-convert, combine, separate, alternate or substitute based on a shared brand, similar numbers or a claim about frequency; have the exact packs and full medicine list reviewed by a pharmacist or prescriber." }, { "zh": "当前标签对突然停用、心率变慢、低血压、心衰/液体潴留、糖尿病低血糖症状掩盖以及与地高辛、胺碘酮、维拉帕米/地尔硫卓类、降压药和降糖药等联用列有需要核对的线索。它们不是网页可以据此决定“能不能一起吃、谁先停或怎么错开”的答案。", "en": "The current label flags abrupt discontinuation, slow heart rate, low blood pressure, heart failure/fluid retention, masking of low-glucose symptoms in diabetes, and review cues with digoxin, amiodarone, verapamil/diltiazem-type products, blood-pressure medicines and glucose-lowering medicines. These do not let a webpage decide whether products can be used together, which to stop first or how to separate them." }, { "zh": "出现昏厥、显著头晕、胸痛、呼吸困难、心率明显异常、体重或水肿快速变化、意识改变或其他急性严重不适时，应优先使用当地紧急医疗支持；不要等待网页检索，也不要自行骤停或靠另一盒心血管药抵消。", "en": "With fainting, marked dizziness, chest pain, breathing difficulty, a clearly abnormal heart rate, rapid change in weight or swelling, altered consciousness or another acute severe problem, prioritise local urgent medical support; do not wait for a website search, abruptly self-stop, or try to counteract it with another cardiovascular pack." } ], "source": { "id": "src_7a6d051d5bf5e431", "label": "DailyMed（NLM）：COREG 卡维地洛当前美国公开标签（Waylis Therapeutics；Warnings, Interactions and Patient Counseling）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=07c619c6-4a0c-445e-94fa-664a54f68a39", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "卡维地洛怎样起作用：它具有 α1 与 β 肾上腺素能阻断作用", "en": "How carvedilol works: it has alpha-1 and beta-adrenergic blocking activity" }, "summary": { "zh": "美国 COREG 标签将卡维地洛描述为具有 α1 阻断和非选择性 β 肾上腺素能阻断活性的药物。这个机制帮助理解为何心率、血压、心脏功能、呼吸状况、糖尿病和完整药单需要一起核对；它不预测个人疗效、耐受性、片数、是否适合、是否需要基因检测或与任何其他药的联用方案。", "en": "The U.S. COREG label describes carvedilol as having alpha-1 blocking and nonselective beta-adrenergic blocking activity. This helps explain why heart rate, blood pressure, cardiac function, respiratory status, diabetes and the complete medicine list need joint review; it does not predict individual benefit, tolerance, tablet count, suitability, need for genetic testing or a plan to combine with another medicine." }, "checks": [ { "zh": "“α/β 阻断”是作用路径，不是从网页判断某人心率、血压、胸闷、乏力或头晕一定由哪种药引起的工具。任何新症状、化验或监测异常都需要结合准确产品、病情和全部药单由专业人员判断。", "en": "“Alpha/beta blocking” is a mechanism pathway, not a web tool for deciding which medicine causes a person's heart rate, blood pressure, chest symptoms, fatigue or dizziness. Any new symptom, test or monitoring issue needs professional review with the exact product, condition and complete medicine list." }, { "zh": "与其他影响心率、传导、血压、血糖或体液状态的产品同用时，不能因为类别不同、都用于心血管问题或看起来不是同一种药就推定可以联用。尤其是地高辛、胺碘酮、某些钙通道阻滞剂、降压药、降糖药和非处方/补充剂都应带实际包装一起核对。", "en": "When another product affects heart rate, conduction, blood pressure, glucose or fluid status, a different class, shared cardiovascular use or a different-looking pack does not prove combination is safe. In particular, digoxin, amiodarone, certain calcium-channel blockers, blood-pressure medicines, glucose-lowering medicines and OTC/supplement products should be reviewed together with the actual packs." }, { "zh": "机制不能替代对缓释胶囊与普通片剂、不同强度、目标市场、既往反应和完整药单的逐项核对。考虑开始、停用、改量、换剂型、掰开药片或遇到新的明显不适时，应及时联系当地药师或医生。", "en": "Mechanism does not replace item-by-item checking of extended-release capsules versus regular tablets, different strengths, target market, prior reactions and the full medicine list. For a contemplated start, stop, adjustment, form change, tablet splitting or a new concerning symptom, contact a local pharmacist or clinician promptly." } ], "source": { "id": "src_7a6d051d5bf5e431", "label": "DailyMed（NLM）：COREG 卡维地洛当前美国公开标签（Waylis Therapeutics；Clinical Pharmacology）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=07c619c6-4a0c-445e-94fa-664a54f68a39", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "Coreg", "generic": "卡维地洛", "dosageFormClass": "普通口服薄膜衣片：3.125 mg、6.25 mg、12.5 mg、25 mg；不与 COREG CR 缓释胶囊混同" }, "labelSource": { "id": "src_7a6d051d5bf5e431", "label": "DailyMed（NLM）：COREG 卡维地洛当前美国公开标签（Waylis Therapeutics；SPL v3，2026-08-03 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=07c619c6-4a0c-445e-94fa-664a54f68a39", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "productRoutes": [ { "source": { "id": "src_7a6d051d5bf5e431", "label": "DailyMed（NLM）：COREG 卡维地洛当前美国公开标签（Waylis Therapeutics；SPL v3，2026-08-03 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=07c619c6-4a0c-445e-94fa-664a54f68a39", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "美国 DailyMed 的当前 COREG（carvedilol）标签列示 3.125、6.25、12.5、25 mg 四种普通口服薄膜衣片。本页逐项展示四个 100 片瓶装面板，帮助核对品牌、通用名、每片标示量、NDC、普通片剂与来源；不把包装上的毫克数转成个人片数、加减量、掰开、补用、停用、联用或换药方案。", "history": "COREG 普通片与 COREG CR 缓释胶囊不是同一剂型或同一产品身份。商品名中都有“Coreg”、通用名相近或数字看起来可对应，都不能建立毫克对毫克换算、合用、轮换或替换关系。", "sourceDocuments": [ { "id": "src_7a6d051d5bf5e431", "label": "DailyMed（NLM）：COREG 卡维地洛当前美国公开标签（Waylis Therapeutics；SPL v3，2026-08-03 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=07c619c6-4a0c-445e-94fa-664a54f68a39", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_952c673477e77d40", "label": "FDA：COREG（carvedilol）NDA 020297 历史批准资料", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20297s4_Coreg.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "approval_history", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_5ed30b676fbb9773", "label": "FDA Drugs@FDA 官方检索入口", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_lookup_entry", "documentKind": "regulatory_lookup", "market": "US", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } ], "applicationNumber": "NDA 020297", "approvalTimeline": [ { "date": "1995", "title": { "zh": "当前标签所列美国初始批准年份", "en": "Initial U.S. approval year listed in the current label" }, "detail": { "zh": "当前 COREG 标签列示 Initial U.S. Approval: 1995。这个年份只定位本页所链接的美国标签和历史申请资料，不建立中国大陆、欧盟、日本或其他市场的批准、持有人、供应、可售资格、原研/仿制关系或个人适用性。", "en": "The current COREG label lists Initial U.S. Approval: 1995. This year only locates the U.S. label and historical application material linked on this page; it does not establish approval, holder, supply, sale eligibility, originator/generic relationship or individual suitability in Mainland China, the EU, Japan or another market." }, "source": { "id": "src_7a6d051d5bf5e431", "label": "DailyMed（NLM）：COREG 卡维地洛当前美国公开标签（Waylis Therapeutics；SPL v3，2026-08-03 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=07c619c6-4a0c-445e-94fa-664a54f68a39", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, { "date": "2026-08-03", "title": { "zh": "当前 DailyMed SPL v3 公开", "en": "Current DailyMed SPL v3 published" }, "detail": { "zh": "DailyMed 媒体目录列示 COREG 当前 SPL v3 于 2026-08-03 发布；页面更新日期为 2026-07-31。本页分别展示四个准确 100 片瓶装面板，不据此建立实际库存、购买、个人片数、COREG CR 转换或其他市场状态。", "en": "The DailyMed media catalogue lists current COREG SPL v3 as published on 3 Aug 2026; the page update date is 31 Jul 2026. This page separately displays four exact 100-tablet bottle panels and does not establish actual stock, purchase, individual tablet count, conversion to COREG CR or another-market status." }, "source": { "id": "src_7a6d051d5bf5e431", "label": "DailyMed（NLM）：COREG 卡维地洛当前美国公开标签（Waylis Therapeutics；SPL v3，2026-08-03 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=07c619c6-4a0c-445e-94fa-664a54f68a39", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "已链接当前公开标签与四个准确 100 片瓶装面板", "en": "Current public label and four exact 100-tablet bottle panels linked" }, "detail": { "zh": "本页面板分别对应 NDC 80725-139-20（3.125 mg）、80725-140-20（6.25 mg）、80725-141-20（12.5 mg）和 80725-142-20（25 mg）。它们不用于鉴定真伪，也不建立实际在售、库存、购买、个人片数、掰开、停用、联用或可替代性。", "en": "The panels correspond respectively to NDC 80725-139-20 (3.125 mg), 80725-140-20 (6.25 mg), 80725-141-20 (12.5 mg) and 80725-142-20 (25 mg). They do not authenticate a product or establish actual availability, stock, purchase, individual tablet count, splitting, discontinuation, co-use or interchangeability." } }, { "market": { "zh": "中国大陆、欧盟、日本及其他市场", "en": "Mainland China, EU, Japan and other markets" }, "status": { "zh": "待逐项建立市场记录", "en": "Market record not established" }, "detail": { "zh": "不从美国标签、NDC 或品牌名称推定当地商品名、批准、包装、供应、可售资格、原研/仿制关系或可替代性；每个市场都需按当地现行监管资料单独核对。", "en": "No local trade name, approval, packaging, supply, sale eligibility, originator/generic relationship or interchangeability is inferred from the U.S. label, NDC or brand name; every market needs separate checking against current local regulatory information." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "COREG 普通片与 COREG CR 缓释胶囊能否按毫克数或服用频率自行换算？", "en": "Can regular COREG tablets and COREG CR extended-release capsules be self-converted by milligrams or dosing frequency?" }, "answer": { "zh": "不能。本页普通片的品牌、通用名、毫克数、NDC 和包装信息只能用于核对准确产品身份。缓释胶囊有不同剂型和标签层面；不要凭相同品牌、相近数字或照片自行换算、替换、叠加或停用。请带两种实际药盒、处方和完整药单请药师或开方团队核对。", "en": "No. The brand, generic name, milligrams, NDC and package information for the regular tablets on this page only help identify the exact product. The extended-release capsule is a different dosage-form and label layer; do not self-convert, substitute, combine or stop based on a shared brand, similar numbers or a photo. Take both actual packs, the prescription and complete medicine list to a pharmacist or prescriber for review." } } ], "relatedMedicineChecks": [ { "target": { "id": "lanoxin", "brand": "Lanoxin", "generic": "地高辛", "canonicalUrls": { "zh": "https://origindrug.com/drugs/lanoxin/", "en": "https://origindrug.com/en/drugs/lanoxin/" } }, "title": { "zh": "与 LANOXIN／地高辛同在药单上时：先做完整药单核对", "en": "When LANOXIN / digoxin is on the same list: review the complete medicine list first" }, "summary": { "zh": "COREG 的当前美国公开标签将地高辛列为需要核对的联用线索，并提示两者都可能影响房室传导和心率。这张卡只提示将全部实际药盒、非处方药、补充剂与近期症状带给药师或开方团队复核；它不判断能否同服，不建议自行停用、错开时间、替换或调整任何一种药。", "en": "The current U.S. COREG public label names digoxin as a co-medication cue requiring review and notes that both can affect atrioventricular conduction and heart rate. This card only signals that every actual pack, OTC product, supplement and recent symptom should be reviewed by a pharmacist or prescriber; it does not decide co-use or advise self-stopping, time-separation, replacement or adjustment of either medicine." }, "source": { "id": "src_7a6d051d5bf5e431", "label": "DailyMed（NLM）：COREG 卡维地洛当前美国公开标签（Waylis Therapeutics；Warnings, Interactions and Patient Counseling）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=07c619c6-4a0c-445e-94fa-664a54f68a39", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "review_complete_medicine_list_no_self_directed_change" } ], "relatedArticleSlugs": [] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/coreg/", "en": "https://origindrug.com/en/drugs/coreg/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "toprol-xl", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-30", "status": "published_traceable_archive" }, "names": { "brand": "Toprol-XL", "generic": "琥珀酸美托洛尔", "aliases": [ "倍他乐克", "倍他乐克缓释片", "metoprolol succinate", "metoprolol extended release", "metoprolol succinate extended release", "琥珀酸美托洛尔缓释片" ], "marketBrandNames": [ { "name": "倍他乐克®缓释片", "market": { "zh": "中国大陆（阿斯利康中国公开产品列表）", "en": "Mainland China (AstraZeneca China public product list)" }, "evidenceStatus": "publication_status_unresolved", "note": { "zh": "阿斯利康中国产品列表将倍他乐克®缓释片对应为琥珀酸美托洛尔缓释片，并列出 47.5 mg 与 95 mg。这里仅建立中国药盒名称检索入口；本档案主体仍是美国 TOPROL-XL 25/50/100/200 mg，跨市场规格与包装不能合并或换算。", "en": "AstraZeneca China's product list maps Betaloc ZOK® to metoprolol succinate extended-release tablets and lists 47.5 mg and 95 mg. This is only a China pack-name search route; the dossier remains the U.S. TOPROL-XL 25/50/100/200 mg product, and cross-market strengths and packages must not be merged or converted." }, "source": { "id": "src_74aa269ebb2ff692", "label": "阿斯利康中国：倍他乐克®缓释片（琥珀酸美托洛尔缓释片）产品列表", "url": "https://www.astrazeneca.com.cn/zh/our-focus-areas/cvm.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "first_party_product_page", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" } } ], "mainlandChinaTradeNameCue": { "value": "倍他乐克®缓释片", "status": "discovery_cue_requires_target_market_verification", "source": { "id": "src_74aa269ebb2ff692", "label": "阿斯利康中国：倍他乐克®缓释片（琥珀酸美托洛尔缓释片）产品列表", "url": "https://www.astrazeneca.com.cn/zh/our-focus-areas/cvm.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "first_party_product_page", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" } } }, "identity": { "therapeuticArea": "心血管", "sourceArchiveMarket": "美国当前公开监管标签；中国大陆商品名仅作一手来源约束的检索线索", "dosageFormClass": "口服缓释片（25、50、100、200 mg；DailyMed 2026 标签所列）", "dosageFormClassCode": "oral_modified_release", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "1992（美国标签所列初始批准年份）", "archiveSponsorText": "DailyMed 公开监管标签档案；中国大陆名称线索来自阿斯利康中国公开产品列表" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [ "metoprolol tartrate", "metoprolol immediate release", "immediate release metoprolol", "lopressor", "metoprolol injection", "酒石酸美托洛尔", "美托洛尔普通片", "美托洛尔注射液", "倍他乐克平片" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-toprol-xl-er-tablet-25mg-ndc-70842-110-02", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v7，2026-03-03 更新；2026-03-06 发布", "en": "DailyMed SPL v7, updated 3 Mar 2026 and published 6 Mar 2026" }, "dosageForm": { "zh": "TOPROL-XL 琥珀酸美托洛尔缓释口服片", "en": "TOPROL-XL metoprolol succinate extended-release oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 70842-110-02", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片 25 mg；100 片瓶装（缓释片）", "en": "25 mg per tablet; 100-tablet bottle (extended-release tablet)" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=496ddfaa-7c9c-4888-b747-a210249b367a&name=toprol-06.jpg", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "琥珀酸美托洛尔", "en": "metoprolol succinate" }, "value": 25, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签强度；不是个人片数、分片或转换规则", "en": "labelled strength per tablet; not an individual tablet-count, splitting or conversion rule" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "100 片瓶装", "en": "100-tablet bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": null, "package": { "count": 100, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "白色", "en": "white" }, "shape": { "zh": "椭圆形、双凸薄膜衣片", "en": "oval biconvex film-coated tablet" }, "imprint": "A/β", "scoreStatus": "scored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_e4a96f0457fcd5f8", "label": "DailyMed（NLM）：TOPROL-XL 琥珀酸美托洛尔 25 mg、100 片瓶装（Melinta；SPL v7，2026-03-03 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=496ddfaa-7c9c-4888-b747-a210249b367a", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-toprol-xl-er-tablet-50mg-ndc-70842-111-02", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v7，2026-03-03 更新；2026-03-06 发布", "en": "DailyMed SPL v7, updated 3 Mar 2026 and published 6 Mar 2026" }, "dosageForm": { "zh": "TOPROL-XL 琥珀酸美托洛尔缓释口服片", "en": "TOPROL-XL metoprolol succinate extended-release oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 70842-111-02", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片 50 mg；100 片瓶装（缓释片）", "en": "50 mg per tablet; 100-tablet bottle (extended-release tablet)" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=496ddfaa-7c9c-4888-b747-a210249b367a&name=toprol-05.jpg", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "琥珀酸美托洛尔", "en": "metoprolol succinate" }, "value": 50, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签强度；不是个人片数、分片或转换规则", "en": "labelled strength per tablet; not an individual tablet-count, splitting or conversion rule" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "100 片瓶装", "en": "100-tablet bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": null, "package": { "count": 100, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "白色", "en": "white" }, "shape": { "zh": "圆形、双凸薄膜衣片", "en": "round biconvex film-coated tablet" }, "imprint": "A/mo", "scoreStatus": "scored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_e4a96f0457fcd5f8", "label": "DailyMed（NLM）：TOPROL-XL 琥珀酸美托洛尔 50 mg、100 片瓶装（Melinta；SPL v7，2026-03-03 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=496ddfaa-7c9c-4888-b747-a210249b367a", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-toprol-xl-er-tablet-100mg-ndc-70842-112-02", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v7，2026-03-03 更新；2026-03-06 发布", "en": "DailyMed SPL v7, updated 3 Mar 2026 and published 6 Mar 2026" }, "dosageForm": { "zh": "TOPROL-XL 琥珀酸美托洛尔缓释口服片", "en": "TOPROL-XL metoprolol succinate extended-release oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 70842-112-02", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片 100 mg；100 片瓶装（缓释片）", "en": "100 mg per tablet; 100-tablet bottle (extended-release tablet)" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=496ddfaa-7c9c-4888-b747-a210249b367a&name=toprol-04.jpg", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "琥珀酸美托洛尔", "en": "metoprolol succinate" }, "value": 100, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签强度；不是个人片数、分片或转换规则", "en": "labelled strength per tablet; not an individual tablet-count, splitting or conversion rule" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "100 片瓶装", "en": "100-tablet bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": null, "package": { "count": 100, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "白色", "en": "white" }, "shape": { "zh": "圆形、双凸薄膜衣片", "en": "round biconvex film-coated tablet" }, "imprint": "A/ms", "scoreStatus": "scored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_e4a96f0457fcd5f8", "label": "DailyMed（NLM）：TOPROL-XL 琥珀酸美托洛尔 100 mg、100 片瓶装（Melinta；SPL v7，2026-03-03 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=496ddfaa-7c9c-4888-b747-a210249b367a", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-toprol-xl-er-tablet-200mg-ndc-70842-113-02", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v7，2026-03-03 更新；2026-03-06 发布", "en": "DailyMed SPL v7, updated 3 Mar 2026 and published 6 Mar 2026" }, "dosageForm": { "zh": "TOPROL-XL 琥珀酸美托洛尔缓释口服片", "en": "TOPROL-XL metoprolol succinate extended-release oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 70842-113-02", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片 200 mg；100 片瓶装（缓释片）", "en": "200 mg per tablet; 100-tablet bottle (extended-release tablet)" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=496ddfaa-7c9c-4888-b747-a210249b367a&name=toprol-03.jpg", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "琥珀酸美托洛尔", "en": "metoprolol succinate" }, "value": 200, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签强度；不是个人片数、分片或转换规则", "en": "labelled strength per tablet; not an individual tablet-count, splitting or conversion rule" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "100 片瓶装", "en": "100-tablet bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": null, "package": { "count": 100, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "白色", "en": "white" }, "shape": { "zh": "椭圆形、双凸薄膜衣片", "en": "oval biconvex film-coated tablet" }, "imprint": "A/mY", "scoreStatus": "scored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_e4a96f0457fcd5f8", "label": "DailyMed（NLM）：TOPROL-XL 琥珀酸美托洛尔 200 mg、100 片瓶装（Melinta；SPL v7，2026-03-03 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=496ddfaa-7c9c-4888-b747-a210249b367a", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-toprol-xl-er-tablet-25mg-ndc-70842-110-02", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=496ddfaa-7c9c-4888-b747-a210249b367a&name=toprol-06.jpg", "alt": "TOPROL-XL 琥珀酸美托洛尔在美国 DailyMed 当前公开标签中的 25 mg、NDC 70842-110-02、100 片瓶装展示面", "archiveMarket": "美国", "labelVersion": "DailyMed 2026-03 更新", "presentation": "TOPROL-XL 琥珀酸美托洛尔：每片 25 mg，NDC 70842-110-02，100 片瓶装展示面。", "notice": "此图只对应美国 DailyMed 当前标签中的 TOPROL-XL、琥珀酸美托洛尔 25 mg、NDC 70842-110-02 和 100 片瓶装。它仅帮助核对品牌、通用名、每片标示量、缓释片、包装数量、刻痕和来源；不用于鉴定真伪，也不证明 50 mg、100 mg、200 mg、其他包装、其他市场、当前可得性、原研身份、可替代性或任何个人的分片、联用、开始、停用或换药方案。", "source": { "id": "src_e4a96f0457fcd5f8", "label": "DailyMed（NLM）：TOPROL-XL 琥珀酸美托洛尔当前美国公开标签（Melinta；SPL v7，2026-03-03 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=496ddfaa-7c9c-4888-b747-a210249b367a", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "TOPROL-XL 说明书放大阅读：美托洛尔名称相近，释放方式不能省略", "en": "TOPROL-XL label reading: a similar metoprolol name does not erase release form" }, "summary": { "zh": "本模块以 DailyMed 2026 美国公开标签为阅读入口，帮助区分 TOPROL-XL、琥珀酸美托洛尔、口服缓释片、25/50/100/200 mg 与准确瓶装；它不决定个人该服多少、是否转换或与其他心血管药合用。", "en": "This module uses the 2026 U.S. DailyMed public label as a reading entry point. It separates TOPROL-XL, metoprolol succinate, extended-release oral tablets, 25/50/100/200 mg and exact bottles; it does not decide an individual's amount, switch or combination with another cardiovascular medicine." }, "checks": [ { "zh": "先同时核对 TOPROL-XL、琥珀酸美托洛尔、缓释片、每片标示强度和目标市场。包装上都出现“美托洛尔”或数字相近，不能证明可按片数自行换算、替代或交替使用。", "en": "Check TOPROL-XL, metoprolol succinate, extended-release tablet, stated strength per tablet and target market together. A shared “metoprolol” name or similar number does not prove products can be self-converted, substituted or alternated by tablet count." }, { "zh": "“缓释”描述制剂在给药间隔内的释放设计，不是“效果更强”或“可随意掰碎”的通用结论。是否可分割、吞服方式或能否改用另一种剂型，只能按该准确产品的现行标签和药师意见确认。", "en": "“Extended release” describes a formulation's release design across the dosing interval; it is not a universal claim of being “stronger” or freely crushable. Splitting, swallowing method or changing to another form can only be confirmed from the current label for that exact product and a pharmacist." }, { "zh": "该标签列有与可乐定、地高辛或某些钙通道阻滞剂等联用时需额外核对的情形，并提示不应自行突然停用。若心率、头晕、胸部不适或用药清单有变化，应带实际包装请医生或药师核对，而不是按网页自行加减或停药。", "en": "The label identifies situations needing extra review with clonidine, digoxin or some calcium-channel blockers, and warns against self-directed abrupt discontinuation. With heart-rate changes, dizziness, chest discomfort or a changed medicine list, bring the actual pack to a clinician or pharmacist rather than self-adjusting or stopping from a webpage." } ], "source": { "id": "src_e4a96f0457fcd5f8", "label": "DailyMed（NLM）：TOPROL-XL 琥珀酸美托洛尔当前美国公开标签（Melinta；SPL v7，2026-03-03 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=496ddfaa-7c9c-4888-b747-a210249b367a", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "琥珀酸美托洛尔怎样起作用：它主要阻断心脏的 β1 肾上腺素能受体", "en": "How metoprolol succinate works: it mainly blocks cardiac beta1 adrenergic receptors" }, "summary": { "zh": "FDA 公开标签将美托洛尔描述为 β1 选择性（心脏选择性）肾上腺素能受体阻断剂；该选择性并非绝对。标签还说明 TOPROL-XL 的缓释设计由多个控释小丸构成，旨在于给药间隔内持续释放。这解释的是作用与剂型设计，不是个人的加减量、停药或与其他心血管药合用方案。", "en": "The FDA public label describes metoprolol as a beta1-selective (cardioselective) adrenergic-receptor blocker; this selectivity is not absolute. It also explains that TOPROL-XL uses multiple controlled-release pellets designed to release metoprolol continuously across the dosing interval. This describes mechanism and formulation design, not an individual's dose change, stopping or combination plan." }, "checks": [ { "zh": "“主要作用于 β1”不代表对每个人都只影响心脏，也不能用作自行判断合并肺部疾病、低心率、头晕或其他药物能否同用的依据。应让医生或药师结合完整情况复核。", "en": "“Mainly beta1” does not mean the effect is confined to the heart in every person, and it cannot decide by itself whether coexisting lung disease, a low heart rate, dizziness or another medicine is compatible. Have a clinician or pharmacist review the full situation." }, { "zh": "缓释机制不等于不能分割。该 FDA 标签对准确的 TOPROL-XL 说明为可沿刻痕分开、但整片或半片均不应压碎或咀嚼；其他美托洛尔产品或市场标签可能不同，不能把这条规则外推。", "en": "An extended-release mechanism does not automatically mean a tablet cannot be divided. The FDA label for this exact TOPROL-XL product says scored tablets may be divided but whole or half tablets must not be crushed or chewed; other metoprolol products or market labels can differ, so do not generalize this rule." }, { "zh": "共同机制也不能决定与可乐定、地高辛、钙通道阻滞剂等如何合用或何时停药。出现心率异常、头晕、胸部不适，或药物清单变化时，带上实际包装请开方团队或药师核对。", "en": "A shared mechanism also cannot decide how to combine with clonidine, digoxin, calcium-channel blockers or when to interrupt treatment. With an abnormal heart rate, dizziness, chest discomfort or a changed medicine list, take the actual pack to the prescribing team or pharmacist for review." } ], "source": { "id": "src_e4a96f0457fcd5f8", "label": "DailyMed（NLM）：TOPROL-XL 琥珀酸美托洛尔当前美国公开标签（Melinta；SPL v7，2026-03-03 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=496ddfaa-7c9c-4888-b747-a210249b367a", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "Toprol-XL", "generic": "琥珀酸美托洛尔", "dosageFormClass": "口服缓释片（25、50、100、200 mg；DailyMed 2026 标签所列）" }, "labelSource": { "id": "src_e4a96f0457fcd5f8", "label": "DailyMed（NLM）：TOPROL-XL 琥珀酸美托洛尔当前美国公开标签（Melinta；SPL v7，2026-03-03 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=496ddfaa-7c9c-4888-b747-a210249b367a", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "productRoutes": [ { "source": { "id": "src_e4a96f0457fcd5f8", "label": "DailyMed（NLM）：TOPROL-XL 琥珀酸美托洛尔当前美国公开标签（Melinta；SPL v7，2026-03-03 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=496ddfaa-7c9c-4888-b747-a210249b367a", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "DailyMed 的 TOPROL-XL（metoprolol succinate）2026 美国公开标签将其列为口服缓释片，列示 25、50、100、200 mg 规格、四个 100 片瓶装 NDC，以及美国初始批准年份为 1992。本页用于放大阅读准确产品身份；不构成个人开始、停用、换药、分片或剂量建议。", "history": "“美托洛尔”不是完整产品身份。缓释制剂与其他盐型、释放方式、规格和目标市场的产品须逐项核对；不要依据名称相近自行把缓释片换成另一种美托洛尔产品。", "sourceDocuments": [ { "id": "src_e4a96f0457fcd5f8", "label": "DailyMed（NLM）：TOPROL-XL 琥珀酸美托洛尔当前美国公开标签（Melinta；SPL v7，2026-03-03 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=496ddfaa-7c9c-4888-b747-a210249b367a", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_5ed30b676fbb9773", "label": "FDA Drugs@FDA 官方检索入口", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_lookup_entry", "documentKind": "regulatory_lookup", "market": "US", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } ], "applicationNumber": "NDA 019962", "approvalTimeline": [ { "date": "1992", "title": { "zh": "FDA 标签所列美国初始批准年份", "en": "Initial U.S. approval year listed in the FDA label" }, "detail": { "zh": "本页链接的 FDA 标签档案列示 Initial U.S. Approval: 1992。该历史定位不等同于当前批准、可得性、持有人或其他市场状态。", "en": "The FDA label archive linked here lists Initial U.S. Approval: 1992. This historical locator is not a conclusion about current approval, availability, holder or another market." }, "source": { "id": "src_e4a96f0457fcd5f8", "label": "DailyMed: TOPROL-XL current public label", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=496ddfaa-7c9c-4888-b747-a210249b367a", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, { "date": "2026-03", "title": { "zh": "FDA 标签档案版本", "en": "FDA label archive version" }, "detail": { "zh": "本页链接 2026-03 的 FDA 标签档案作为可复核阅读入口。现行标签、规格、适应症和安全信息必须另行以目标市场当前文件核对。", "en": "This page links the 2026-03 FDA label archive as a traceable reading entry point. Current labeling, strength, indication and safety information require separate verification against the target market’s current document." }, "source": { "id": "src_e4a96f0457fcd5f8", "label": "DailyMed: TOPROL-XL current public label", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=496ddfaa-7c9c-4888-b747-a210249b367a", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "已链接公开标签档案", "en": "Public label archive linked" }, "detail": { "zh": "仅对应本页所列 FDA 文件。", "en": "Only the FDA document listed on this page is linked." } }, { "market": { "zh": "中国大陆、欧盟、日本", "en": "Mainland China, EU, Japan" }, "status": { "zh": "待逐项建立市场记录", "en": "Market record not established" }, "detail": { "zh": "不从美国标签档案推定当地批准、持有人、规格、供应或可售资格。", "en": "No local approval, holder, strength, supply or sale-eligibility conclusion is inferred from the U.S. label archive." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "标签档案能代表现在的产品信息吗？", "en": "Does a label archive represent current product information?" }, "answer": { "zh": "不能自动代表。档案用于定位来源；需要以目标市场的现行官方标签逐项复核。", "en": "Not automatically. The archive locates a source; each point needs verification against the target market’s current official label." } }, { "question": { "zh": "为什么这里不展示价格或原研/仿制结论？", "en": "Why are price and originator/generic conclusions not shown?" }, "answer": { "zh": "这些结论需要产品、剂型、规格、包装、市场、日期和原始记录分别齐全并经人工审核；单一标签文件不足以支持。", "en": "Those conclusions require separately complete and human-reviewed product, dosage-form, strength, pack, market, date and primary-record fields; one label file is insufficient." } } ], "relatedMedicineChecks": [ { "target": { "id": "lopressor", "brand": "LOPRESSOR", "generic": "酒石酸美托洛尔", "canonicalUrls": { "zh": "https://origindrug.com/drugs/lopressor/", "en": "https://origindrug.com/en/drugs/lopressor/" } }, "title": { "zh": "与 LOPRESSOR／酒石酸美托洛尔同在药单上时：先区分缓释片与普通片", "en": "When LOPRESSOR / metoprolol tartrate is on the same list: first separate extended-release and standard tablets" }, "summary": { "zh": "TOPROL-XL 的美国公开标签将其标为琥珀酸美托洛尔缓释片；LOPRESSOR 是酒石酸美托洛尔普通口服片。共同出现“美托洛尔”或相近 mg 数字，只提示把两种实际药盒和完整药单交给药师或开方团队核对；本卡片不判断能否同用，也不建议自行停用、错开时间、替换或调整任何一种药。", "en": "The U.S. public label identifies TOPROL-XL as an extended-release metoprolol succinate tablet, while LOPRESSOR is a standard metoprolol tartrate oral tablet. A shared ‘metoprolol’ name or similar mg number only signals that both actual packs and the complete medicine list need pharmacist or prescriber review; this card does not decide co-use or advise self-stopping, time-separation, replacement or adjustment of either medicine." }, "source": { "id": "src_e4a96f0457fcd5f8", "label": "DailyMed（NLM）：TOPROL-XL 琥珀酸美托洛尔当前美国公开标签（Melinta；SPL v7，2026-03-03 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=496ddfaa-7c9c-4888-b747-a210249b367a", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "review_complete_medicine_list_no_self_directed_change" } ], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "how-to-read-a-drug-label", "regulatory-sources-first" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/toprol-xl/", "en": "https://origindrug.com/en/drugs/toprol-xl/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "lanoxin", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-19", "status": "published_traceable_archive" }, "names": { "brand": "Lanoxin", "generic": "地高辛", "aliases": [ "LANOXIN", "digoxin" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "心血管", "sourceArchiveMarket": "美国当前 LANOXIN 地高辛片公开标签（2024-12 修订；DailyMed SPL v12 于 2025-01-09 发布）", "dosageFormClass": "口服片：62.5 mcg、125 mcg、250 mcg（当前美国片剂标签所列）", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "1954（当前美国片剂标签所列 Initial U.S. Approval）", "archiveSponsorText": "Advanz Pharma (US) Corp. / DailyMed（NLM）当前片剂公开标签档案" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [ "LANOXIN injection", "LANOXIN oral solution", "digoxin injection", "digoxin oral solution", "LANOXIN pediatric injection" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-lanoxin-62-5mcg-bottle-ndc-59212-240-55", "marketCode": "US", "labelVersion": { "zh": "处方信息 2024-12 修订；DailyMed SPL v12 于 2025-01-09 发布", "en": "Prescribing information revised Dec 2024; DailyMed SPL v12 published 9 Jan 2025" }, "dosageForm": { "zh": "地高辛口服片", "en": "digoxin oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 59212-240-55", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片 62.5 mcg；100 片瓶装", "en": "62.5 mcg per tablet; 100-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=62-5mcgbottle.jpg&setid=d91e3646-4c63-4512-ab22-db39c085c4dc&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "地高辛", "en": "digoxin" }, "value": 62.5, "unit": "mcg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标示量", "en": "labelled amount per tablet" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "100 片瓶装", "en": "100-tablet bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-19", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "桃橙色", "en": "peach/orange" }, "shape": { "zh": "5 mm 圆片", "en": "5 mm round tablet" }, "imprint": "LANOXIN / U3A", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_821b4ed2b7f909c6", "label": "DailyMed（NLM）：LANOXIN 地高辛片当前美国公开标签（Advanz Pharma；2024-12 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=d91e3646-4c63-4512-ab22-db39c085c4dc", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-05", "reviewedAt": "2026-09-05" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-lanoxin-125mcg-bottle-ndc-59212-242-55", "marketCode": "US", "labelVersion": { "zh": "处方信息 2024-12 修订；DailyMed SPL v12 于 2025-01-09 发布", "en": "Prescribing information revised Dec 2024; DailyMed SPL v12 published 9 Jan 2025" }, "dosageForm": { "zh": "地高辛口服片", "en": "digoxin oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 59212-242-55", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片 125 mcg；100 片瓶装", "en": "125 mcg per tablet; 100-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=125mcgbottle.jpg&setid=d91e3646-4c63-4512-ab22-db39c085c4dc&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "地高辛", "en": "digoxin" }, "value": 125, "unit": "mcg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标示量", "en": "labelled amount per tablet" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "100 片瓶装", "en": "100-tablet bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-19", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "黄色", "en": "yellow" }, "shape": { "zh": "6 mm 圆片", "en": "6 mm round tablet" }, "imprint": "LANOXIN / Y3B", "scoreStatus": "scored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_821b4ed2b7f909c6", "label": "DailyMed（NLM）：LANOXIN 地高辛片当前美国公开标签（Advanz Pharma；2024-12 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=d91e3646-4c63-4512-ab22-db39c085c4dc", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-05", "reviewedAt": "2026-09-05" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-lanoxin-125mcg-unit-dose-ndc-59212-242-56", "marketCode": "US", "labelVersion": { "zh": "处方信息 2024-12 修订；DailyMed SPL v12 于 2025-01-09 发布", "en": "Prescribing information revised Dec 2024; DailyMed SPL v12 published 9 Jan 2025" }, "dosageForm": { "zh": "地高辛口服片", "en": "digoxin oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 59212-242-56", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片 125 mcg；院内单位剂量装（10 板×10 片）", "en": "125 mcg per tablet; institutional unit-dose pack (10 blisters × 10 tablets)" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=cn-120891-01-lanoxin-125-mcg-tablet-100s-v1thumb.jpg&setid=d91e3646-4c63-4512-ab22-db39c085c4dc&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "地高辛", "en": "digoxin" }, "value": 125, "unit": "mcg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标示量", "en": "labelled amount per tablet" } } ], "concentration": null, "container": { "typeCode": "unit_dose_blister", "typeLabel": { "zh": "院内单位剂量装（10 板×10 片）", "en": "institutional unit-dose pack (10 blisters × 10 tablets)" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "片/单位剂量盒", "en": "tablets per unit-dose carton" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-19", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "片/单位剂量盒", "en": "tablets per unit-dose carton" } }, "physicalClues": { "color": { "zh": "黄色", "en": "yellow" }, "shape": { "zh": "6 mm 圆片", "en": "6 mm round tablet" }, "imprint": "LANOXIN / Y3B", "scoreStatus": "scored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_821b4ed2b7f909c6", "label": "DailyMed（NLM）：LANOXIN 地高辛片当前美国公开标签（Advanz Pharma；2024-12 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=d91e3646-4c63-4512-ab22-db39c085c4dc", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-05", "reviewedAt": "2026-09-05" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-lanoxin-250mcg-bottle-ndc-59212-249-55", "marketCode": "US", "labelVersion": { "zh": "处方信息 2024-12 修订；DailyMed SPL v12 于 2025-01-09 发布", "en": "Prescribing information revised Dec 2024; DailyMed SPL v12 published 9 Jan 2025" }, "dosageForm": { "zh": "地高辛口服片", "en": "digoxin oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 59212-249-55", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片 250 mcg；100 片瓶装", "en": "250 mcg per tablet; 100-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=250mcgbottle.jpg&setid=d91e3646-4c63-4512-ab22-db39c085c4dc&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "地高辛", "en": "digoxin" }, "value": 250, "unit": "mcg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标示量", "en": "labelled amount per tablet" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "100 片瓶装", "en": "100-tablet bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-19", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "白色", "en": "white" }, "shape": { "zh": "7 mm 圆片", "en": "7 mm round tablet" }, "imprint": "LANOXIN / X3A", "scoreStatus": "scored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_821b4ed2b7f909c6", "label": "DailyMed（NLM）：LANOXIN 地高辛片当前美国公开标签（Advanz Pharma；2024-12 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=d91e3646-4c63-4512-ab22-db39c085c4dc", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-05", "reviewedAt": "2026-09-05" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-lanoxin-125mcg-bottle-ndc-59212-242-55", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=125mcgbottle.jpg&setid=d91e3646-4c63-4512-ab22-db39c085c4dc&type=img", "alt": "LANOXIN 地高辛当前美国 DailyMed 标签中的 125 mcg、NDC 59212-242-55、100 片瓶装包装面板", "archiveMarket": "美国", "labelVersion": "处方信息 2024-12 修订；DailyMed SPL v12 于 2025-01-09 发布", "presentation": "LANOXIN 地高辛片 125 mcg，NDC 59212-242-55，100 片瓶装", "notice": "此图只对应美国当前片剂标签中的 125 mcg 瓶装。它不代表 62.5 mcg、250 mcg、院内单位剂量装、LANOXIN 注射剂、generic 地高辛口服液或其他市场；不用于鉴定真伪，也不生成个人片数、分片、血药浓度或转换方案。", "source": { "id": "src_821b4ed2b7f909c6", "label": "DailyMed（NLM）：LANOXIN 地高辛片当前美国公开标签（Advanz Pharma；2024-12 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=d91e3646-4c63-4512-ab22-db39c085c4dc", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-05", "reviewedAt": "2026-09-05" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "LANOXIN 说明书放大阅读：mcg 与 mg 相差一千倍，剂型也必须分开", "en": "LANOXIN label reading: mcg and mg differ by a thousand-fold, and dosage form must remain separate" }, "summary": { "zh": "本模块只帮助核对片剂商品名、每片 mcg、NDC、刻痕与包装；不生成片数、分片、血药浓度目标、漏用、转换或停药。", "en": "This module only helps check the tablet brand, mcg per tablet, NDC, score and pack; it does not generate tablet counts, splitting, serum targets, missed-use, conversion or stopping." }, "checks": [ { "zh": "1 mg = 1000 mcg。62.5/125/250 mcg 分别只等于 0.0625/0.125/0.25 mg；“125 mg”不是“125 mcg”，而是后一数值的一千倍。这个关系用于防止单位误读，不是个人剂量换算器。", "en": "1 mg = 1000 mcg. The 62.5/125/250 mcg labels equal 0.0625/0.125/0.25 mg respectively; 125 mg is not 125 mcg but a thousand-fold larger. This relationship prevents unit misreading; it is not a personal dose converter." }, { "zh": "125 mcg 同时有 100 片瓶装和院内单位剂量装，必须继续核对 NDC 与包装。包装不同不自动改变每片标示量，也不能据此判断个人应拿几片。", "en": "The 125 mcg tablet appears in both a 100-tablet bottle and an institutional unit-dose pack, so NDC and pack still matter. A different pack does not automatically change the amount per tablet or determine an individual's tablet count." }, { "zh": "62.5 mcg 无刻痕；125 mcg 与 250 mcg 标签列有刻痕。刻痕是准确 presentation 的外观线索，不代表网页可以决定任何人能否分片或怎样分。", "en": "The 62.5 mcg tablet is unscored; the 125 mcg and 250 mcg tablets are labelled as scored. A score is an appearance clue for an exact presentation, not permission for a webpage to decide whether or how someone splits a tablet." }, { "zh": "LANOXIN 注射剂是另一 NDA、SPL、途径与浓度表达；generic 地高辛口服液也不是本页片剂。相同品牌或通用名不支持按 mcg、mL 或途径自行换算。", "en": "LANOXIN injection has a different NDA, SPL, route and concentration expression; generic digoxin oral solution is also not this tablet record. A shared brand or generic name does not support self-conversion by mcg, mL or route." }, { "zh": "恶心呕吐、持续腹泻、明显乏力或意识改变、视物异常、心悸/晕厥或疑似误用时，应及时联系当地医生、药师、毒物咨询或紧急医疗支持；不要依据网页自行补服、停用或改量。", "en": "With nausea/vomiting, persistent diarrhoea, marked weakness or confusion, visual disturbance, palpitations/fainting or suspected misuse, promptly contact local clinicians, pharmacists, poison-control or emergency support; do not self-make-up, stop or change an amount from this page." } ], "source": { "id": "src_821b4ed2b7f909c6", "label": "DailyMed（NLM）：LANOXIN 地高辛片当前美国公开标签（Advanz Pharma；2024-12 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=d91e3646-4c63-4512-ab22-db39c085c4dc", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-05", "reviewedAt": "2026-09-05" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "地高辛怎样起作用：标签描述对 Na+/K+-ATPase 的抑制及其心脏效应", "en": "How digoxin works: the label describes Na+/K+-ATPase inhibition and cardiac effects" }, "summary": { "zh": "当前片剂标签描述地高辛抑制 Na+/K+-ATPase，并由此影响细胞内离子与心肌收缩。机制用于理解为何单位、肾功能、相互作用、心率/节律和监测都需要专业复核；不预测个人效果或给药量。", "en": "The current tablet label describes digoxin inhibition of Na+/K+-ATPase and resulting effects on intracellular ions and myocardial contraction. This helps explain why units, kidney function, interactions, rate/rhythm and monitoring need professional review; it does not predict an individual's effect or amount." }, "checks": [ { "zh": "机制不能从症状或手表读数判断某个人是否需要地高辛，也不能解释一次血药浓度是否应调整；诊断、监测时点与结果必须由专业人员结合准确产品和临床背景判断。", "en": "Mechanism cannot determine from symptoms or a watch reading whether someone needs digoxin or whether one serum result warrants a change. Diagnosis, sampling time and interpretation need professionals with the exact product and clinical context." }, { "zh": "作用于心率/传导并不使 LANOXIN 与其他心律、心衰或血压产品可自行叠加、轮换、替代或按 mg 换算；完整药单、肾功能和电解质背景都要核对。", "en": "Effects on rate/conduction do not make LANOXIN self-combinable, alternatable, substitutable or milligram-convertible with another rhythm, heart-failure or blood-pressure product. The complete medicine list, kidney function and electrolyte context all need review." }, { "zh": "机制不能处理疑似中毒、明显心悸、晕厥、意识改变或严重胃肠道/视觉症状；出现急性严重担忧时应优先使用当地紧急医疗支持。", "en": "Mechanism cannot manage suspected toxicity, marked palpitations, fainting, confusion or severe gastrointestinal/visual symptoms; prioritise local urgent medical support for an acute serious concern." } ], "source": { "id": "src_821b4ed2b7f909c6", "label": "DailyMed（NLM）：LANOXIN 当前美国片剂标签（Clinical Pharmacology）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=d91e3646-4c63-4512-ab22-db39c085c4dc", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-05", "reviewedAt": "2026-09-05" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "Lanoxin", "generic": "地高辛", "dosageFormClass": "口服片：62.5 mcg、125 mcg、250 mcg（当前美国片剂标签所列）" }, "labelSource": { "id": "src_821b4ed2b7f909c6", "label": "DailyMed（NLM）：LANOXIN 地高辛片当前美国公开标签（Advanz Pharma；2024-12 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=d91e3646-4c63-4512-ab22-db39c085c4dc", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-05", "reviewedAt": "2026-09-05" }, "productRoutes": [ { "source": { "id": "src_821b4ed2b7f909c6", "label": "DailyMed（NLM）：LANOXIN 地高辛片当前美国公开标签（Advanz Pharma；2024-12 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=d91e3646-4c63-4512-ab22-db39c085c4dc", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-05", "reviewedAt": "2026-09-05" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-09-05", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-09-05", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "DailyMed 的 LANOXIN（digoxin）当前美国片剂标签列出 62.5 mcg、125 mcg 与 250 mcg。页面始终保留 mcg，并把 125 mcg 的瓶装与院内单位剂量装分开；它不把 mcg 静默改成同数字 mg，也不生成个人片数、血药浓度目标、漏用、加减量、分片、注射—口服转换或停药方案。", "history": "当前片剂标签列示美国初始批准年份为 1954，NDA 020405。LANOXIN 注射剂现属 NDA 009330 和独立标签；generic digoxin oral solution 也不是本品牌片剂 presentation，因此均不并入本页当前四个包装。", "sourceDocuments": [ { "id": "src_821b4ed2b7f909c6", "label": "DailyMed（NLM）：LANOXIN 地高辛片当前美国公开标签（Advanz Pharma；2024-12 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=d91e3646-4c63-4512-ab22-db39c085c4dc", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-05", "reviewedAt": "2026-09-05" } ], "applicationNumber": "NDA 020405", "approvalTimeline": [ { "date": "1954", "title": { "zh": "标签所列美国初始批准年份", "en": "Initial U.S. approval year listed in the label" }, "detail": { "zh": "当前 LANOXIN 片剂标签列示 Initial U.S. Approval: 1954；该年份不自动说明其他市场状态。", "en": "The current LANOXIN tablet label lists Initial U.S. Approval: 1954; that year does not establish status in another market." }, "source": { "id": "src_821b4ed2b7f909c6", "label": "DailyMed: current LANOXIN tablet public label", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=d91e3646-4c63-4512-ab22-db39c085c4dc", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-05", "reviewedAt": "2026-09-05" } }, { "date": "2024-12-05", "title": { "zh": "当前处方信息更新/修订", "en": "Current prescribing-information update/revision" }, "detail": { "zh": "DailyMed 页面将 Drug Label Information Updated 标为 2024-12-05，正文列示 Revised 12/2024。", "en": "DailyMed lists Drug Label Information Updated as 5 Dec 2024 and the prescribing information as Revised 12/2024." }, "source": { "id": "src_821b4ed2b7f909c6", "label": "DailyMed: current LANOXIN tablet public label", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=d91e3646-4c63-4512-ab22-db39c085c4dc", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-05", "reviewedAt": "2026-09-05" } }, { "date": "2025-01-09", "title": { "zh": "DailyMed SPL v12 公开", "en": "DailyMed SPL v12 published" }, "detail": { "zh": "DailyMed 当前版本列表将 v12 标为 current，并列示 2025-01-09 Published；该日期与正文修订月分开。", "en": "DailyMed marks v12 as current and lists Published 9 Jan 2025; this remains separate from the prescribing-information revision month." }, "source": { "id": "src_821b4ed2b7f909c6", "label": "DailyMed: current LANOXIN tablet public label", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=d91e3646-4c63-4512-ab22-db39c085c4dc", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-05", "reviewedAt": "2026-09-05" } } ], "marketStatus": [ { "market": { "zh": "美国片剂", "en": "United States tablets" }, "status": { "zh": "已链接 NDA 020405 当前公开标签", "en": "Current NDA 020405 public label linked" }, "detail": { "zh": "四个 presentation 仅对应 Advanz 当前片剂标签中的有效包装。", "en": "The four presentations correspond only to active packs in the current Advanz tablet label." } }, { "market": { "zh": "LANOXIN 注射剂、generic 地高辛口服液及其他市场", "en": "LANOXIN injection, generic digoxin oral solution and other markets" }, "status": { "zh": "明确分开或待建立", "en": "Explicitly separate or not established" }, "detail": { "zh": "不同 NDA、SPL、剂型、途径或品牌状态不得并入本片剂档案。", "en": "A different NDA, SPL, form, route or brand status is not merged into this tablet dossier." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "125 mcg 是不是 125 mg？", "en": "Is 125 mcg the same as 125 mg?" }, "answer": { "zh": "不是。1 mg = 1000 mcg，因此 125 mcg = 0.125 mg。该换算只用于防止单位误读，不决定任何人的片数或用量。", "en": "No. 1 mg = 1000 mcg, so 125 mcg = 0.125 mg. This equivalence only prevents unit misreading and does not determine anyone's tablet count or amount." } }, { "question": { "zh": "药单里同时有地高辛和胺碘酮，可以按原来的方法继续吃吗？", "en": "If digoxin and amiodarone are both on the medicine list, can the previous routine simply continue?" }, "answer": { "zh": "网页不能确认。当前官方标签同时提示地高辛浓度升高及心率／传导方面的联用风险线索；应尽快由开方团队或药师核对两盒实际药、完整药单、肾功能、电解质、心率／心电及既有监测结果。不要自行停用、错开、掰片、补服或调整任何一种药。", "en": "A webpage cannot confirm that. Current official labels flag both increased digoxin concentration and rate/conduction concerns with this combination. Promptly have the prescribing team or pharmacist review both actual packs, the complete medicine list, kidney function, electrolytes, heart-rate/ECG information and existing monitoring results. Do not self-stop, separate, split, catch up or adjust either medicine." } }, { "question": { "zh": "老人一直吃同样的地高辛，为什么还要看肾功能和新加的药？", "en": "Why should an older adult on the same digoxin routine still review kidney function and newly added medicines?" }, "answer": { "zh": "当前 LANOXIN 标签说明高龄、低体重、肾功能受损和电解质异常会增加地高辛毒性风险；地高辛主要经肾脏排泄，联用药也可能改变其浓度或心率／传导效应。是否需要改变方案必须由专业人员结合准确产品、检查与监测判断，网页不能给出减量或停药结论。", "en": "The current LANOXIN label identifies advanced age, low body weight, impaired renal function and electrolyte abnormalities as toxicity risk factors. Digoxin is mainly excreted by the kidneys, and co-medications may alter its concentration or rate/conduction effects. Any change requires professional interpretation of the exact product, tests and monitoring; this page provides no reduction or stopping decision." } }, { "question": { "zh": "服地高辛时出现恶心、视物异常、明显乏力、心悸或晕厥怎么办？", "en": "What should someone do if nausea, visual changes, marked weakness, palpitations or fainting occurs while taking digoxin?" }, "answer": { "zh": "这些可能是需要及时评估的警讯，但网页不能判断原因。应立即联系负责团队；若症状严重、出现晕厥、明显意识改变、胸部严重不适或其他急性危险表现，应使用当地紧急医疗渠道。不要等待网页答复，也不要自行补服、停用或换药。", "en": "These can be warning signs requiring prompt assessment, but a webpage cannot determine the cause. Contact the responsible team immediately; severe symptoms, fainting, marked altered awareness, serious chest discomfort or another acute danger sign requires local emergency care. Do not wait for a web answer or self-catch-up, stop or switch." } } ], "relatedMedicineChecks": [ { "target": { "id": "amiodarone-cordarone", "brand": "CORDARONE", "generic": "胺碘酮", "canonicalUrls": { "zh": "https://origindrug.com/drugs/amiodarone-cordarone/", "en": "https://origindrug.com/en/drugs/amiodarone-cordarone/" } }, "title": { "zh": "与 CORDARONE／胺碘酮同在药单上时：地高辛浓度与心率／传导都要专业核对", "en": "When CORDARONE / amiodarone is on the same list: digoxin concentration and rate/conduction need professional review" }, "summary": { "zh": "当前美国 LANOXIN 片剂标签说明：地高辛的中毒浓度只略高于治疗浓度，选择方案时要考虑年龄、体重、肾功能和联用药；其相互作用表还列出胺碘酮会升高地高辛血清浓度。当前胺碘酮通用名标签同时把地高辛列为可增强心动过缓、窦性停搏和房室传导阻滞风险线索的负性变时药。本卡只要求尽快把两种实际药盒、完整药单、近期肾功能／电解质、心率或心电记录及既有地高辛监测结果交给开方团队或药师核对；它不判断能否同用，不提供浓度目标、减量比例、给药间隔、停药或换药方案，也不建议自行错开、掰片、漏服补用或调整任何一种药。CORDARONE 页面属于历史品牌档案；当前通用名标签不证明该品牌当前供应。", "en": "The current U.S. LANOXIN tablet label says toxic digoxin concentrations are only slightly higher than therapeutic concentrations, and that age, body weight, renal function and concomitant medicines matter when a regimen is selected; its interaction table also lists increased serum digoxin concentration with amiodarone. A current U.S. generic amiodarone label separately lists digoxin as a negative chronotrope that can add to bradycardia, sinus arrest and AV block. This card only calls for prompt review of both actual packs, the complete medicine list, recent kidney-function/electrolyte information, heart-rate or ECG records and any existing digoxin-monitoring results by the prescribing team or pharmacist. It does not decide co-use or provide a concentration target, reduction percentage, timing interval, stop or switch plan, and does not advise self-separation, tablet splitting, catch-up use or adjustment of either medicine. The CORDARONE page is a historical brand archive; a current generic label does not establish current brand supply." }, "source": { "id": "src_821b4ed2b7f909c6", "label": "DailyMed（NLM）：LANOXIN 地高辛片当前美国公开标签（胺碘酮相互作用、治疗窗与老人／肾功能核对）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=d91e3646-4c63-4512-ab22-db39c085c4dc", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-05", "reviewedAt": "2026-09-05" }, "scope": "review_complete_medicine_list_no_self_directed_change" } ], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "dosage-forms-are-part-of-medicine-identity", "how-to-read-a-drug-label" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/lanoxin/", "en": "https://origindrug.com/en/drugs/lanoxin/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "lanoxin-injection", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-21", "status": "published_traceable_archive" }, "names": { "brand": "LANOXIN Injection", "generic": "地高辛注射液", "aliases": [ "LANOXIN Injection", "LANOXIN Pediatric Injection", "digoxin injection", "地高辛注射液" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "心血管", "sourceArchiveMarket": "美国当前 LANOXIN 地高辛注射液公开标签（2025-10 修订；DailyMed SPL v10 于 2025-11-17 发布）", "dosageFormClass": "地高辛注射液：500 mcg/2 mL（250 mcg/mL）单剂量瓶；LANOXIN Injection Pediatric 100 mcg/mL 单剂量瓶（当前美国标签所列）", "dosageFormClassCode": "intravenous_infusion", "route": "肌内 / 静脉注射", "routeCode": "intravenous", "historicalApprovalEntry": "1954（当前美国注射剂标签所列 Initial U.S. Approval）", "archiveSponsorText": "Covis Pharma US, Inc. / DailyMed（NLM）当前注射剂公开标签档案" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [ "LANOXIN tablet", "LANOXIN oral solution", "digoxin oral solution", "LANOXIN 62.5 mcg tablet", "LANOXIN 125 mcg tablet", "LANOXIN 250 mcg tablet" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-lanoxin-injection-adult-500mcg-2ml-vial-ndc-70515-261-10", "marketCode": "US", "labelVersion": { "zh": "处方信息 2025-10 修订；DailyMed SPL v10 于 2025-11-17 发布", "en": "Prescribing information revised Oct 2025; DailyMed SPL v10 published 17 Nov 2025" }, "dosageForm": { "zh": "地高辛单剂量注射液瓶", "en": "digoxin single-dose injection vial" }, "route": { "zh": "肌内／静脉注射（只作标签身份字段）", "en": "intramuscular / intravenous injection (label identity only)" }, "routeCodes": [ "intramuscular", "intravenous" ], "productCode": "NDC 70515-261-10", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_vial", "primaryDisplay": { "zh": "500 mcg/2 mL（250 mcg/mL）；10 支单剂量瓶装", "en": "500 mcg/2 mL (250 mcg/mL); 10 single-dose vials" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=image-04.jpg&setid=9ec84cac-6ecc-43dc-8006-6ccc029e2707&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "地高辛", "en": "digoxin" }, "value": 500, "unit": "mcg", "basisCode": "per_vial", "basisLabel": { "zh": "每支单剂量瓶标签总量；不是个人注射量", "en": "labelled total per single-dose vial; not an individual's injection amount" } } ], "concentration": { "basisCode": "micrograms_per_mL", "notation": null, "numerator": { "value": 250, "unit": "mcg" }, "denominator": { "value": 1, "unit": "mL" }, "display": { "zh": "250 mcg/mL", "en": "250 mcg/mL" } }, "container": { "typeCode": "single_dose_vial", "typeLabel": { "zh": "单剂量瓶", "en": "single-dose vial" }, "fill": { "value": 2, "unit": "mL" }, "countPerPackage": 10, "countUnit": { "zh": "支/盒", "en": "vials per carton" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-21", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 10, "unit": { "zh": "支单剂量瓶/盒", "en": "single-dose vials per carton" } }, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_c8f22cc32be8fb37", "label": "DailyMed（NLM）：LANOXIN 地高辛注射液当前美国公开标签（Covis Pharma US；2025-10 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=9ec84cac-6ecc-43dc-8006-6ccc029e2707", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-lanoxin-injection-pediatric-100mcg-1ml-vial-ndc-70515-263-10", "marketCode": "US", "labelVersion": { "zh": "处方信息 2025-10 修订；DailyMed SPL v10 于 2025-11-17 发布", "en": "Prescribing information revised Oct 2025; DailyMed SPL v10 published 17 Nov 2025" }, "dosageForm": { "zh": "LANOXIN Injection Pediatric 地高辛单剂量注射液瓶", "en": "LANOXIN Injection Pediatric digoxin single-dose injection vial" }, "route": { "zh": "肌内／静脉注射（只作标签身份字段）", "en": "intramuscular / intravenous injection (label identity only)" }, "routeCodes": [ "intramuscular", "intravenous" ], "productCode": "NDC 70515-263-10", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_vial", "primaryDisplay": { "zh": "100 mcg/mL；1 mL；10 支单剂量瓶装", "en": "100 mcg/mL; 1 mL; 10 single-dose vials" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=image-06.jpg&setid=9ec84cac-6ecc-43dc-8006-6ccc029e2707&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "地高辛", "en": "digoxin" }, "value": 100, "unit": "mcg", "basisCode": "per_vial", "basisLabel": { "zh": "每支 1 mL 单剂量瓶标签量；不是个人注射量", "en": "labelled amount in the 1 mL single-dose vial; not an individual's injection amount" } } ], "concentration": { "basisCode": "micrograms_per_mL", "notation": null, "numerator": { "value": 100, "unit": "mcg" }, "denominator": { "value": 1, "unit": "mL" }, "display": { "zh": "100 mcg/mL", "en": "100 mcg/mL" } }, "container": { "typeCode": "single_dose_vial", "typeLabel": { "zh": "单剂量瓶", "en": "single-dose vial" }, "fill": { "value": 1, "unit": "mL" }, "countPerPackage": 10, "countUnit": { "zh": "支/盒", "en": "vials per carton" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-21", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 10, "unit": { "zh": "支单剂量瓶/盒", "en": "single-dose vials per carton" } }, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_c8f22cc32be8fb37", "label": "DailyMed（NLM）：LANOXIN 地高辛注射液当前美国公开标签（Covis Pharma US；2025-10 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=9ec84cac-6ecc-43dc-8006-6ccc029e2707", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-lanoxin-injection-adult-500mcg-2ml-vial-ndc-70515-261-10", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=image-04.jpg&setid=9ec84cac-6ecc-43dc-8006-6ccc029e2707&type=img", "alt": "LANOXIN 地高辛注射液当前美国 DailyMed 标签中的 500 mcg/2 mL、NDC 70515-261-10、十支单剂量瓶包装面板", "archiveMarket": "美国", "labelVersion": "处方信息 2025-10 修订；DailyMed SPL v10 于 2025-11-17 发布", "presentation": "LANOXIN 地高辛注射液 500 mcg/2 mL（250 mcg/mL），NDC 70515-261-10，10 支单剂量瓶装", "notice": "此图只对应当前美国标签中的成人 500 mcg/2 mL 单剂量瓶。它不代表 Pediatric 100 mcg/mL、已列营销结束日的安瓿、LANOXIN 片剂、generic 地高辛口服液或其他市场；不用于鉴定真伪，也不生成个人注射、输注、换算或换药方案。", "source": { "id": "src_c8f22cc32be8fb37", "label": "DailyMed（NLM）：LANOXIN 地高辛注射液当前美国公开标签（Covis Pharma US；2025-10 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=9ec84cac-6ecc-43dc-8006-6ccc029e2707", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "LANOXIN 注射液说明书放大阅读：先核对浓度、NDC 与单剂量瓶，不做换算", "en": "LANOXIN Injection label reading: check concentration, NDC and single-dose vial first; do not self-convert" }, "summary": { "zh": "本模块只帮助区分当前美国标签中的两个单剂量瓶、浓度与 NDC；不生成个人注射量、频率、途径转换、输注操作、片剂/口服液换算、漏用或停用方案。", "en": "This module only distinguishes the two single-dose vials, concentrations and NDCs in the current U.S. label; it does not generate individual injection amounts, frequency, route conversion, infusion steps, tablet/oral-solution conversion, missed-use or stopping plans." }, "checks": [ { "zh": "成人瓶为 500 mcg/2 mL（250 mcg/mL），Pediatric 瓶为 100 mcg/mL、1 mL。它们是不同标签 identity；页面不把浓度、瓶内总量或 mL 变成个人注射量或换算器。", "en": "The adult vial is 500 mcg/2 mL (250 mcg/mL); the Pediatric vial is 100 mcg/mL and 1 mL. They are different label identities; this page does not turn concentration, vial total or mL into an individual injection amount or converter." }, { "zh": "必须继续核对 NDC：成人单剂量瓶为 70515-261-10，Pediatric 单剂量瓶为 70515-263-10。相同品牌、通用名或“注射液”文字不足以互换两种瓶。", "en": "Continue by checking the NDC: the adult single-dose vial is 70515-261-10 and the Pediatric single-dose vial is 70515-263-10. A shared brand, generic name or the word “injection” is not enough to exchange the two vials." }, { "zh": "当前标签还列有已标明营销结束日的成人及儿科安瓿；本页不把它们当作当前包装，也不据此判断任何实际供应或可获得性。", "en": "The current label also lists adult and pediatric ampules with a stated marketing-end date. This page does not present them as current packages or infer any real-world supply or availability." }, { "zh": "LANOXIN 片剂、generic 地高辛口服液和本注射剂属于不同的剂型、NDA 或标签链路。不要按 mcg、mL、途径或品牌名称自行换算、替换、叠加或改变使用方式。", "en": "LANOXIN tablets, generic digoxin oral solution and this injection belong to different form, NDA or label chains. Do not self-convert, substitute, combine or change use by mcg, mL, route or brand name." }, { "zh": "若出现明显心悸、晕厥、意识改变、严重恶心呕吐、视觉异常或疑似误用，应尽快联系当地医生、药师、毒物咨询或紧急医疗支持；不要依据网页自行继续、补用、停用或改量。", "en": "With marked palpitations, fainting, confusion, severe nausea/vomiting, visual disturbance or suspected misuse, promptly contact local clinicians, pharmacists, poison-control or emergency support; do not self-continue, make up, stop or change an amount from this page." } ], "source": { "id": "src_c8f22cc32be8fb37", "label": "DailyMed（NLM）：LANOXIN 地高辛注射液当前美国公开标签（Covis Pharma US；2025-10 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=9ec84cac-6ecc-43dc-8006-6ccc029e2707", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "地高辛怎样起作用：同一机制不等于不同剂型可以自行换算", "en": "How digoxin works: a shared mechanism does not make different forms self-convertible" }, "summary": { "zh": "当前注射剂标签描述地高辛对 Na+/K+-ATPase 的抑制及其心脏效应。机制帮助理解为什么准确剂型、浓度、途径、肾功能、相互作用与监测需要专业核对；不预测个人效果或注射量。", "en": "The current injection label describes digoxin inhibition of Na+/K+-ATPase and cardiac effects. Mechanism helps explain why exact form, concentration, route, kidney function, interactions and monitoring need professional review; it does not predict an individual's effect or injection amount." }, "checks": [ { "zh": "机制不能从症状或设备读数判断某个人是否应使用地高辛注射剂，也不能决定何时注射、通过何种途径或是否转回口服。", "en": "Mechanism cannot determine from symptoms or device readings whether someone should use digoxin injection, when it should be given, by which route, or whether to change back to oral use." }, { "zh": "作用于心率/传导不使本注射剂与片剂、口服液或其他心律、心衰、血压产品可自行叠加、轮换、替代或按单位换算。", "en": "Effects on rate/conduction do not make this injection self-combinable, alternatable, substitutable or unit-convertible with tablets, oral solution or another rhythm, heart-failure or blood-pressure product." }, { "zh": "机制不能处理疑似中毒、明显心悸、晕厥、意识改变或严重胃肠道/视觉症状；有急性严重担忧时应优先使用当地紧急医疗支持。", "en": "Mechanism cannot manage suspected toxicity, marked palpitations, fainting, confusion or severe gastrointestinal/visual symptoms; prioritise local urgent medical support for an acute serious concern." } ], "source": { "id": "src_c8f22cc32be8fb37", "label": "DailyMed（NLM）：LANOXIN 地高辛注射液当前美国公开标签（Covis Pharma US；2025-10 修订；Clinical Pharmacology）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=9ec84cac-6ecc-43dc-8006-6ccc029e2707", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "LANOXIN Injection", "generic": "地高辛注射液", "dosageFormClass": "地高辛注射液：500 mcg/2 mL（250 mcg/mL）单剂量瓶；LANOXIN Injection Pediatric 100 mcg/mL 单剂量瓶（当前美国标签所列）" }, "labelSource": { "id": "src_c8f22cc32be8fb37", "label": "DailyMed（NLM）：LANOXIN 地高辛注射液当前美国公开标签（Covis Pharma US；2025-10 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=9ec84cac-6ecc-43dc-8006-6ccc029e2707", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "productRoutes": [ { "source": { "id": "src_c8f22cc32be8fb37", "label": "DailyMed（NLM）：LANOXIN 地高辛注射液当前美国公开标签（Covis Pharma US；2025-10 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=9ec84cac-6ecc-43dc-8006-6ccc029e2707", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "DailyMed 的 LANOXIN 地高辛注射液当前美国标签列出成人 500 mcg/2 mL（250 mcg/mL）与 Pediatric 100 mcg/mL 两个单剂量瓶。页面把 NDC、浓度、单剂量瓶与标签所列肌内／静脉途径分开呈现；不生成任何个人注射量、频率、输注安排、途径转换、片剂／口服液换算、漏用或停用方案。", "history": "当前注射剂标签对应 NDA 009330，并与 LANOXIN 片剂的 NDA 020405 分开。页面仅展示截至 2026-08-21 在当前标签中列示、且未列出营销结束日的两个小瓶；已列营销结束日的成人与儿科安瓿不作为当前公开 presentation。", "sourceDocuments": [ { "id": "src_c8f22cc32be8fb37", "label": "DailyMed（NLM）：LANOXIN 地高辛注射液当前美国公开标签（Covis Pharma US；2025-10 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=9ec84cac-6ecc-43dc-8006-6ccc029e2707", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } ], "applicationNumber": "NDA 009330", "approvalTimeline": [ { "date": "1954", "title": { "zh": "当前注射剂标签所列美国初始批准年份", "en": "Initial U.S. approval year listed in the current injection label" }, "detail": { "zh": "当前 LANOXIN 注射剂标签列示 Initial U.S. Approval: 1954；该年份不把片剂、口服液或其他市场并入本档案。", "en": "The current LANOXIN injection label lists Initial U.S. Approval: 1954; that year does not merge tablets, oral solution or another market into this dossier." }, "source": { "id": "src_c8f22cc32be8fb37", "label": "DailyMed: current U.S. LANOXIN digoxin-injection public label", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=9ec84cac-6ecc-43dc-8006-6ccc029e2707", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, { "date": "2025-10-17", "title": { "zh": "当前标签页面更新/处方信息修订", "en": "Current label-page update / prescribing-information revision" }, "detail": { "zh": "DailyMed 页面将 Drug Label Information Updated 标为 2025-10-17，正文列示 Revised 10/2025；它与后续 SPL 公开日期分开记录。", "en": "DailyMed lists Drug Label Information Updated as 17 Oct 2025 and the text as Revised 10/2025; these remain separate from the subsequent SPL publication date." }, "source": { "id": "src_c8f22cc32be8fb37", "label": "DailyMed: current U.S. LANOXIN digoxin-injection public label", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=9ec84cac-6ecc-43dc-8006-6ccc029e2707", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, { "date": "2025-11-17", "title": { "zh": "DailyMed SPL v10 公开", "en": "DailyMed SPL v10 published" }, "detail": { "zh": "DailyMed 当前版本列表将 v10 标为 current，并列示 2025-11-17 Published。", "en": "DailyMed marks v10 as current and lists Published 17 Nov 2025." }, "source": { "id": "src_c8f22cc32be8fb37", "label": "DailyMed: current U.S. LANOXIN digoxin-injection public label", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=9ec84cac-6ecc-43dc-8006-6ccc029e2707", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } } ], "marketStatus": [ { "market": { "zh": "美国注射剂", "en": "United States injection" }, "status": { "zh": "已链接 NDA 009330 当前公开标签与两个现行标签所列单剂量瓶", "en": "Current NDA 009330 public label and two label-listed single-dose vials linked" }, "detail": { "zh": "本档案仅展示 NDC 70515-261-10 成人 500 mcg/2 mL 单剂量瓶与 NDC 70515-263-10 Pediatric 100 mcg/mL 单剂量瓶。它不证明实际在售、库存、可获得性，亦不纳入已列营销结束日的安瓿。", "en": "This dossier displays only the adult 500 mcg/2 mL single-dose vial, NDC 70515-261-10, and the Pediatric 100 mcg/mL single-dose vial, NDC 70515-263-10. It does not establish actual marketing, stock or availability, and does not include ampules with a stated marketing-end date." } }, { "market": { "zh": "LANOXIN 片剂、generic 地高辛口服液及其他市场", "en": "LANOXIN tablets, generic digoxin oral solution and other markets" }, "status": { "zh": "明确分开或待建立", "en": "Explicitly separate or not established" }, "detail": { "zh": "不同 NDA、SPL、剂型、浓度、途径或品牌状态不得并入本注射剂档案。", "en": "A different NDA, SPL, form, concentration, route or brand status is not merged into this injection dossier." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "500 mcg/2 mL（250 mcg/mL）和 100 mcg/mL 能自己按 mL 换算或替换吗？", "en": "Can 500 mcg/2 mL (250 mcg/mL) and 100 mcg/mL be self-converted or substituted by mL?" }, "answer": { "zh": "不能。它们是不同的标签包装身份。本页不提供注射或浓度换算器；应带上实际 NDC、单剂量瓶和完整药单，由药师或处方团队核对。", "en": "No. They are different labelled package identities. This page provides no injection or concentration converter; take the actual NDC, single-dose vial and complete medicine list to a pharmacist or prescribing team for review." } }, { "question": { "zh": "LANOXIN 注射剂能按同品牌或同通用名转成片剂或口服液吗？", "en": "Can LANOXIN Injection be changed to tablets or oral solution because the brand or generic name is shared?" }, "answer": { "zh": "不能。片剂、口服液和注射剂的标签链路、剂型、浓度或途径不同。本页不提供任何转换、替换、加减量或联合使用结论。", "en": "No. Tablets, oral solution and injection have different label chains, forms, concentrations or routes. This page provides no conversion, substitution, adjustment or combination conclusion." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "dosage-forms-are-part-of-medicine-identity", "how-to-read-a-drug-label" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/lanoxin-injection/", "en": "https://origindrug.com/en/drugs/lanoxin-injection/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "monoket", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-26", "status": "published_traceable_archive" }, "names": { "brand": "MONOKET", "generic": "异山梨酯单硝酸酯", "aliases": [ "MONOKET", "monoket", "isosorbide mononitrate", "异山梨酯单硝酸酯" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "心血管", "sourceArchiveMarket": "美国：本页仅链接 FDA 的 MONOKET 异山梨酯单硝酸酯 10 mg、20 mg 口服片历史说明书及 2022 年补充批准函；不建立中国大陆、欧盟、日本或其他市场的批准、供应、可售、持有人或原研/仿制结论。", "dosageFormClass": "MONOKET 异山梨酯单硝酸酯 10 mg／20 mg 口服片（美国历史标签）；不得与同成分缓释片、其他硝酸酯或相近名称产品混作同一产品", "dosageFormClassCode": "oral_modified_release", "route": "口服（历史标签产品身份字段）", "routeCode": "oral", "historicalApprovalEntry": "FDA 美国历史公开说明书（2014-10 修订）及补充批准函（2022-02-01）", "archiveSponsorText": "未依据历史文件建立当前持有人或供应结论" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [ "IMDUR", "isosorbide mononitrate extended-release", "异山梨酯单硝酸酯缓释片", "nitroglycerin", "硝酸甘油", "isosorbide dinitrate", "二硝酸异山梨酯" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-monoket-isosorbide-mononitrate-tablet-10mg-100bottle-ndc-62175-3610-1-historical", "marketCode": "US", "labelVersion": { "zh": "FDA 美国历史公开说明书（2014-10 修订）", "en": "FDA U.S. historical prescribing information (revised Oct 2014)" }, "dosageForm": { "zh": "MONOKET 异山梨酯单硝酸酯口服片", "en": "MONOKET isosorbide mononitrate oral tablet" }, "route": { "zh": "口服（历史标签产品身份字段）", "en": "oral (historical-label product identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 62175-3610-1", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片异山梨酯单硝酸酯 10 mg；100 片瓶装（美国历史标签）", "en": "Isosorbide mononitrate 10 mg per tablet; 100-tablet bottle (U.S. historical label)" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "异山梨酯单硝酸酯", "en": "isosorbide mononitrate" }, "value": 10, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片历史标签标示量；不是个人片数、频率、换算或换药指令", "en": "historical labelled amount per tablet; not an individual's tablet count, frequency, conversion or switching instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-26", "currentLabelDisplayed": false, "ndcDirectoryListed": false, "marketAvailability": "historical_label_record_only", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_18db70770282e7d3", "label": "FDA：MONOKET 10 mg、NDC 62175-3610-1、100 片瓶装的美国历史标签身份字段（2014-10）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020215s024lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-monoket-isosorbide-mononitrate-tablet-20mg-100bottle-ndc-62175-3620-1-historical", "marketCode": "US", "labelVersion": { "zh": "FDA 美国历史公开说明书（2014-10 修订）", "en": "FDA U.S. historical prescribing information (revised Oct 2014)" }, "dosageForm": { "zh": "MONOKET 异山梨酯单硝酸酯口服片", "en": "MONOKET isosorbide mononitrate oral tablet" }, "route": { "zh": "口服（历史标签产品身份字段）", "en": "oral (historical-label product identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 62175-3620-1", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片异山梨酯单硝酸酯 20 mg；100 片瓶装（美国历史标签）", "en": "Isosorbide mononitrate 20 mg per tablet; 100-tablet bottle (U.S. historical label)" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "异山梨酯单硝酸酯", "en": "isosorbide mononitrate" }, "value": 20, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片历史标签标示量；不是个人片数、频率、换算或换药指令", "en": "historical labelled amount per tablet; not an individual's tablet count, frequency, conversion or switching instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-26", "currentLabelDisplayed": false, "ndcDirectoryListed": false, "marketAvailability": "historical_label_record_only", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_18db70770282e7d3", "label": "FDA：MONOKET 20 mg、NDC 62175-3620-1、100 片瓶装的美国历史标签身份字段（2014-10）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020215s024lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "status": "withheld_repackaged_or_non_exact_visual", "title": { "zh": "已核验历史说明书文字，但未保留与单一规格、单一包装一一对应的官方包装图，故不展示包装图片", "en": "Historical-label text was reviewed, but no official package image matching one exact strength and package was retained, so no package visual is shown" }, "summary": { "zh": "本档案保留 FDA 历史说明书中 MONOKET、异山梨酯单硝酸酯、10 mg／20 mg、两个 NDC 与各 100 片瓶装的文字身份字段。此次未保留能与单一强度、单一 NDC 和单一历史包装逐一对应、可安全公开展示的官方图片；为避免把零售图、版本不明图、同成分缓释片、其他硝酸酯或其他市场图片误作准确 MONOKET 包装，页面不展示包装图片，只保留可放大阅读的一手文件。", "en": "This dossier retains MONOKET, isosorbide mononitrate, 10 mg/20 mg, two NDCs and each 100-tablet bottle as text identity fields from the FDA historical prescribing information. No official image that can safely be matched one to one to one strength, one NDC and one historical package was retained; to avoid treating a retail image, version-uncertain image, same-ingredient extended-release tablet, other nitrate or another-market image as an exact MONOKET pack, the page withholds package imagery and retains the primary document for enlarged reading." }, "source": { "id": "src_18db70770282e7d3", "label": "FDA：MONOKET（异山梨酯单硝酸酯）10 mg／20 mg 美国历史处方信息（2014-10 修订）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020215s024lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "MONOKET 历史说明书放大阅读", "en": "MONOKET historical label reading in larger print" }, "summary": { "zh": "先按准确品牌、通用名、片剂形式、每片标示量与目标市场读这份 FDA 历史文件；它不替代今天的处方、现行标签或专业人员的个人判断。", "en": "Read this FDA historical document first by exact brand, generic name, tablet form, labelled amount per tablet and target market; it does not replace today's prescription, current label or a professional's individual assessment." }, "checks": [ { "zh": "10 mg 与 20 mg 是两种分别列出的历史片剂身份。共同成分、相近 mg 数字或相似名称都不构成自行加减、掰片、补用、轮换、替换或把不同剂型换算的依据。", "en": "10 mg and 20 mg are two separately listed historical tablet identities. A shared ingredient, nearby mg number or similar name is not a basis for self-adjusting, splitting, making up, alternating, substituting or converting another dosage form." }, { "zh": "请把 MONOKET 与同成分缓释片、其他硝酸酯和名称相近产品分开核对。若实际药盒或完整药单中出现这些项目，先让药师或开方团队核对，而不是据页面自行叠加、错开、换用或停用。", "en": "Check MONOKET separately from same-ingredient extended-release tablets, other nitrates and similarly named products. If these appear on the actual pack or complete medicine list, ask a pharmacist or prescribing team to review them before any self-directed combining, spacing, switching or stopping." }, { "zh": "所引 2014 年文件记载了与若干勃起功能障碍用药和利奥西呱有关的禁忌警示。它是历史标签阅读线索，不是针对个人的停药、联用或紧急处理建议；任何实际同用问题需要尽快由了解完整药单的专业人员确认。", "en": "The cited 2014 document records contraindication warnings involving certain erectile-dysfunction medicines and riociguat. This is a historical-label reading cue, not personal advice to stop, combine or manage an urgent issue; any actual co-use question needs prompt confirmation by a professional who knows the complete medicine list." } ], "source": { "id": "src_18db70770282e7d3", "label": "FDA：MONOKET（异山梨酯单硝酸酯）10 mg／20 mg 美国历史处方信息（2014-10 修订）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020215s024lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "异山梨酯单硝酸酯怎样起作用：历史标签描述其使血管平滑肌松弛", "en": "How isosorbide mononitrate works: the historical label describes relaxation of vascular smooth muscle" }, "summary": { "zh": "FDA 的 MONOKET 历史说明书将异山梨酯单硝酸酯列为有机硝酸酯，并说明其主要药理作用是使血管平滑肌松弛，继而扩张外周动脉和静脉。这个机制概述只帮助理解为何血压、头晕、其他硝酸酯及完整药单需要一起核对；它不告诉任何人在胸痛时怎么做、吃几片、何时服、如何加减、联用、停用或换药。", "en": "The FDA historical MONOKET label identifies isosorbide mononitrate as an organic nitrate and describes its principal pharmacological action as relaxation of vascular smooth muscle, followed by dilation of peripheral arteries and veins. This mechanism overview only helps explain why blood pressure, dizziness, other nitrates and the complete medicine list need review together; it does not tell anyone what to do during chest pain, how many tablets to take, when to take them, or how to adjust, combine, stop or switch treatment." }, "checks": [ { "zh": "“血管平滑肌松弛”解释的是药理路径，不代表 MONOKET 10 mg／20 mg 片剂、同成分缓释片、二硝酸异山梨酯、硝酸甘油或其他心血管药可以自行按毫克数互换、叠加、错开或轮换。请把准确药盒和完整药单交由药师或开方团队逐项核对。", "en": "“Vascular smooth-muscle relaxation” explains a pharmacological pathway. It does not make MONOKET 10 mg/20 mg tablets, same-ingredient extended-release tablets, isosorbide dinitrate, nitroglycerin or another cardiovascular medicine self-convertible by milligrams, combinable, separable or alternatable. Have a pharmacist or prescribing team review the exact packs and complete medicine list item by item." }, { "zh": "这份历史标签也明确指出该口服产品起效不够快，不能用于终止一次急性心绞痛发作。机制页面和历史文件都不是急性胸痛自救指南；如有新的或加重的胸痛、晕厥、明显呼吸困难或其他紧急症状，应立即使用当地紧急医疗路径，而不是依据网页自行调整药物。", "en": "The historical label also explicitly states that this oral product does not act rapidly enough to abort an acute angina episode. Neither a mechanism page nor a historical document is an acute-chest-pain self-care guide; with new or worsening chest pain, fainting, marked breathing difficulty or another emergency symptom, use the local emergency pathway immediately rather than self-adjusting medicine from a webpage." }, { "zh": "历史标签中关于 PDE5 抑制剂、利奥西呱、酒精及其他血管扩张药的内容，是提示要完整核对相互作用的线索，不是网页给出的个人停药、联用、错开时间或紧急处理结论。任何实际同用或不适问题，应让了解完整药单的专业人员尽快判断。", "en": "The historical-label material on PDE5 inhibitors, riociguat, alcohol and other vasodilators is a cue for complete interaction review, not a webpage conclusion about an individual's stopping, co-use, spacing or urgent management. Any actual co-use or symptom concern needs prompt assessment by a professional who knows the complete medicine list." } ], "source": { "id": "src_18db70770282e7d3", "label": "FDA：MONOKET（异山梨酯单硝酸酯）美国历史处方信息（2014-10 修订；临床药理）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020215s024lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "MONOKET", "generic": "异山梨酯单硝酸酯", "dosageFormClass": "MONOKET 异山梨酯单硝酸酯 10 mg／20 mg 口服片（美国历史标签）；不得与同成分缓释片、其他硝酸酯或相近名称产品混作同一产品" }, "labelSource": { "id": "src_18db70770282e7d3", "label": "FDA：MONOKET（异山梨酯单硝酸酯）10 mg／20 mg 美国历史处方信息（2014-10 修订）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020215s024lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "productRoutes": [ { "source": { "id": "src_18db70770282e7d3", "label": "FDA：MONOKET（异山梨酯单硝酸酯）10 mg／20 mg 美国历史处方信息（2014-10 修订）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020215s024lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "FDA 历史说明书列示 MONOKET 异山梨酯单硝酸酯 10 mg 和 20 mg 口服片。这里将品牌、通用名、准确片剂强度、历史文件日期和官方原文入口分开呈现；10 mg 与 20 mg 是各自片剂的标签身份，不是个人片数、频率、补用、换药或与其他硝酸酯/同成分产品换算的指令。", "history": "FDA 于 2014-10 修订的历史说明书是本页的主要电子阅读文件。FDA 的 2022-02-01 补充批准函确认了针对 MONOKET 10 mg、20 mg 片剂的一个补充申请；函中所述为检验设施变更，不能据此推定当前标签、生产商、市场供应或个人用药。", "sourceDocuments": [ { "id": "src_18db70770282e7d3", "label": "FDA：MONOKET（异山梨酯单硝酸酯）10 mg／20 mg 美国历史处方信息（2014-10 修订）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020215s024lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_7df690dfa72d84ab", "label": "FDA：MONOKET（异山梨酯单硝酸酯）10 mg／20 mg NDA 020215/S-027 补充批准函（2022-02-01，更正件）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/020215Orig1s027Correctedltr.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_regulatory_record", "documentKind": "approval_letter", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } ], "applicationNumber": "NDA 020215（FDA 历史标签与 2022 补充批准函）", "approvalTimeline": [ { "date": "2014-10", "title": { "zh": "FDA 历史说明书修订", "en": "FDA historical prescribing-information revision" }, "detail": { "zh": "本页链接的 MONOKET 异山梨酯单硝酸酯 10 mg／20 mg 口服片 FDA 说明书标示为 2014-10 修订。它是可复核的历史阅读入口，不代表当前标签、供应、持有人、其他市场状态或个人用药。", "en": "The linked FDA prescribing information for MONOKET isosorbide mononitrate 10 mg/20 mg oral tablets is marked revised October 2014. It is a traceable historical-reading entry point, not a conclusion about current labeling, supply, holder, another-market status or individual use." }, "source": { "id": "src_18db70770282e7d3", "label": "FDA：MONOKET（异山梨酯单硝酸酯）10 mg／20 mg 美国历史处方信息（2014-10 修订）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020215s024lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, { "date": "2022-02-01", "title": { "zh": "NDA 020215/S-027 补充批准（更正件）", "en": "NDA 020215/S-027 supplemental approval (corrected letter)" }, "detail": { "zh": "FDA 的更正批准函记载 MONOKET 10 mg、20 mg 片剂的补充申请于 2022-02-01 获批，所述事项为增加备选辅料分析检测设施。该监管节点不建立当前标签、当前生产商、供应、个人用法或任何市场的可售资格。", "en": "The FDA corrected approval letter records approval on 1 Feb 2022 of a supplement for MONOKET 10 mg and 20 mg tablets, described as adding an alternate analytical testing facility for excipients. This regulatory node does not establish current labeling, current manufacturer, supply, individual use or sale eligibility in any market." }, "source": { "id": "src_7df690dfa72d84ab", "label": "FDA：MONOKET（异山梨酯单硝酸酯）10 mg／20 mg NDA 020215/S-027 补充批准函（2022-02-01，更正件）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/020215Orig1s027Correctedltr.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_regulatory_record", "documentKind": "approval_letter", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "已链接历史标签与补充批准函", "en": "Historical label and supplemental-approval letter linked" }, "detail": { "zh": "仅对应本页所列 FDA 历史文件，不能据此推定当前供应、现行标签、持有人或购买资格。", "en": "Only the FDA historical documents listed on this page are linked; current supply, labeling, holder and sale eligibility are not inferred." } }, { "market": { "zh": "中国大陆、欧盟、日本及其他市场", "en": "Mainland China, EU, Japan and other markets" }, "status": { "zh": "待逐项建立市场记录", "en": "Market record not established" }, "detail": { "zh": "不从美国历史文件推定当地商品名、批准、规格、供应、原研关系或可替代性。", "en": "No local trade name, approval, strength, supply, originator relationship or interchangeability is inferred from the U.S. historical documents." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "这份 FDA 历史文件能代表我手上或本地药房的现行产品吗？", "en": "Does this FDA historical document represent the current product in my hand or local pharmacy?" }, "answer": { "zh": "不能自动代表。它的价值是提供准确品牌、通用名、历史片剂呈现和原始文件的阅读入口；当前产品问题必须回到实际药盒和目标市场的现行官方标签，并由专业人员核对。", "en": "Not automatically. Its value is an entry point to the exact brand, generic name, historical tablet presentations and original document; current-product questions must return to the actual pack and the target market's current official label with professional review." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "dosage-forms-are-part-of-medicine-identity", "how-to-read-a-drug-label" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/monoket/", "en": "https://origindrug.com/en/drugs/monoket/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "zestril", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-09-04", "status": "published_traceable_archive" }, "names": { "brand": "ZESTRIL", "generic": "赖诺普利", "aliases": [ "ZESTRIL", "lisinopril", "lisinopril dihydrate", "赖诺普利", "赖诺普利片", "捷赐瑞" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": { "value": "捷赐瑞®", "status": "discovery_cue_requires_target_market_verification", "source": { "id": "src_1a40ae15b7b7b869", "label": "天津市人社局：历史医保支付范围中的赖诺普利片／捷赐瑞 10 mg、14 片记录", "url": "https://hrss.tj.gov.cn/zhengwugongkai/zhengcezhinan/zxwjnew/202012/W020201206005868511362.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "reimbursement_lookup", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" } } }, "identity": { "therapeuticArea": "心血管", "sourceArchiveMarket": "美国 DailyMed ZESTRIL（lisinopril）当前口服片标签，2024-11 修订、2025-05-05 发布。本档案仅对应标签列出的美国处方片、六个 NDC、相应 90 片瓶装展示面及六种片剂外观；不推定中国大陆或其他市场的当前批准、持有人、供应、可得性或个人适用性。", "dosageFormClass": "口服片：2.5 mg、5 mg、10 mg、20 mg、30 mg、40 mg（DailyMed 美国公开标签所列）", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "1988（DailyMed 当前美国公开标签所列美国初始批准）", "archiveSponsorText": "Upsher-Smith Laboratories, LLC / DailyMed 美国公开标签" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [ "ZESTORETIC", "赖诺普利氢氯噻嗪", "lisinopril and hydrochlorothiazide", "PRINIVIL", "QBRELIS", "ENTRESTO", "lisinopril oral solution", "赖诺普利口服溶液", "lisinopril injection", "赖诺普利注射液" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-zestril-lisinopril-tablet-2-5mg-90bottle-ndc-24979-238-07", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（2024-11 修订；2025-05-05 发布）", "en": "Current U.S. DailyMed public label (revised Nov 2024; published 5 May 2025)" }, "dosageForm": { "zh": "ZESTRIL 赖诺普利口服片", "en": "ZESTRIL lisinopril oral tablet" }, "route": { "zh": "口服（标签产品身份字段）", "en": "oral (label product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 24979-238-07", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片 2.5 mg；90 片瓶装", "en": "2.5 mg per tablet; 90-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=label-2.5-90.jpg&setid=838c2d78-d2d8-4981-9ec9-e50ef9e1a5d8&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "赖诺普利", "en": "lisinopril" }, "value": 2.5, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、疗程或换算", "en": "labelled amount per tablet; not an individual's tablet count, course or conversion" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 90, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-04", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 90, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "白色", "en": "white" }, "shape": { "zh": "圆形、双凸、无包衣，约 7 mm", "en": "round, biconvex and uncoated, about 7 mm" }, "imprint": "ZESTRIL 2½ / 135", "scoreStatus": "unscored_do_not_split", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_218b6a32d18c5ea6", "label": "DailyMed（NLM）：ZESTRIL 赖诺普利当前美国公开标签（Upsher-Smith；2024-11 修订；2025-05-05 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=838c2d78-d2d8-4981-9ec9-e50ef9e1a5d8", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-zestril-lisinopril-tablet-5mg-90bottle-ndc-24979-239-07", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（2024-11 修订；2025-05-05 发布）", "en": "Current U.S. DailyMed public label (revised Nov 2024; published 5 May 2025)" }, "dosageForm": { "zh": "ZESTRIL 赖诺普利口服片", "en": "ZESTRIL lisinopril oral tablet" }, "route": { "zh": "口服（标签产品身份字段）", "en": "oral (label product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 24979-239-07", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片 5 mg；90 片瓶装", "en": "5 mg per tablet; 90-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=label-5-90.jpg&setid=838c2d78-d2d8-4981-9ec9-e50ef9e1a5d8&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "赖诺普利", "en": "lisinopril" }, "value": 5, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、疗程或换算", "en": "labelled amount per tablet; not an individual's tablet count, course or conversion" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 90, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-04", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 90, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "粉红色", "en": "pink" }, "shape": { "zh": "胶囊形、双凸、无包衣，约 8 mm", "en": "capsule-shaped, biconvex and uncoated, about 8 mm" }, "imprint": "ZESTRIL / 130", "scoreStatus": "scored_status_not_a_split_instruction", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_218b6a32d18c5ea6", "label": "DailyMed（NLM）：ZESTRIL 赖诺普利当前美国公开标签（Upsher-Smith；2024-11 修订；2025-05-05 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=838c2d78-d2d8-4981-9ec9-e50ef9e1a5d8", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-zestril-lisinopril-tablet-10mg-90bottle-ndc-24979-240-07", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（2024-11 修订；2025-05-05 发布）", "en": "Current U.S. DailyMed public label (revised Nov 2024; published 5 May 2025)" }, "dosageForm": { "zh": "ZESTRIL 赖诺普利口服片", "en": "ZESTRIL lisinopril oral tablet" }, "route": { "zh": "口服（标签产品身份字段）", "en": "oral (label product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 24979-240-07", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片 10 mg；90 片瓶装", "en": "10 mg per tablet; 90-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=label-10-90.jpg&setid=838c2d78-d2d8-4981-9ec9-e50ef9e1a5d8&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "赖诺普利", "en": "lisinopril" }, "value": 10, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、疗程或换算", "en": "labelled amount per tablet; not an individual's tablet count, course or conversion" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 90, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-04", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 90, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "粉红色", "en": "pink" }, "shape": { "zh": "圆形、双凸、无包衣，约 8 mm", "en": "round, biconvex and uncoated, about 8 mm" }, "imprint": "ZESTRIL 10 / 131", "scoreStatus": "unscored_do_not_split", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_218b6a32d18c5ea6", "label": "DailyMed（NLM）：ZESTRIL 赖诺普利当前美国公开标签（Upsher-Smith；2024-11 修订；2025-05-05 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=838c2d78-d2d8-4981-9ec9-e50ef9e1a5d8", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-zestril-lisinopril-tablet-20mg-90bottle-ndc-24979-241-07", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（2024-11 修订；2025-05-05 发布）", "en": "Current U.S. DailyMed public label (revised Nov 2024; published 5 May 2025)" }, "dosageForm": { "zh": "ZESTRIL 赖诺普利口服片", "en": "ZESTRIL lisinopril oral tablet" }, "route": { "zh": "口服（标签产品身份字段）", "en": "oral (label product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 24979-241-07", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片 20 mg；90 片瓶装", "en": "20 mg per tablet; 90-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=label-20-90.jpg&setid=838c2d78-d2d8-4981-9ec9-e50ef9e1a5d8&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "赖诺普利", "en": "lisinopril" }, "value": 20, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、疗程或换算", "en": "labelled amount per tablet; not an individual's tablet count, course or conversion" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 90, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-04", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 90, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "浅棕红色", "en": "pale brownish red" }, "shape": { "zh": "圆形、双凸、无包衣，约 8 mm", "en": "round, biconvex and uncoated, about 8 mm" }, "imprint": "ZESTRIL 20 / 132", "scoreStatus": "unscored_do_not_split", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_218b6a32d18c5ea6", "label": "DailyMed（NLM）：ZESTRIL 赖诺普利当前美国公开标签（Upsher-Smith；2024-11 修订；2025-05-05 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=838c2d78-d2d8-4981-9ec9-e50ef9e1a5d8", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-zestril-lisinopril-tablet-30mg-90bottle-ndc-24979-242-07", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（2024-11 修订；2025-05-05 发布）", "en": "Current U.S. DailyMed public label (revised Nov 2024; published 5 May 2025)" }, "dosageForm": { "zh": "ZESTRIL 赖诺普利口服片", "en": "ZESTRIL lisinopril oral tablet" }, "route": { "zh": "口服（标签产品身份字段）", "en": "oral (label product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 24979-242-07", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片 30 mg；90 片瓶装", "en": "30 mg per tablet; 90-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=label-30-90.jpg&setid=838c2d78-d2d8-4981-9ec9-e50ef9e1a5d8&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "赖诺普利", "en": "lisinopril" }, "value": 30, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、疗程或换算", "en": "labelled amount per tablet; not an individual's tablet count, course or conversion" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 90, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-04", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 90, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "浅棕红色", "en": "pale brownish red" }, "shape": { "zh": "圆形、双凸、无包衣，约 9 mm", "en": "round, biconvex and uncoated, about 9 mm" }, "imprint": "ZESTRIL 30 / 133", "scoreStatus": "unscored_do_not_split", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_218b6a32d18c5ea6", "label": "DailyMed（NLM）：ZESTRIL 赖诺普利当前美国公开标签（Upsher-Smith；2024-11 修订；2025-05-05 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=838c2d78-d2d8-4981-9ec9-e50ef9e1a5d8", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-zestril-lisinopril-tablet-40mg-90bottle-ndc-24979-243-07", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（2024-11 修订；2025-05-05 发布）", "en": "Current U.S. DailyMed public label (revised Nov 2024; published 5 May 2025)" }, "dosageForm": { "zh": "ZESTRIL 赖诺普利口服片", "en": "ZESTRIL lisinopril oral tablet" }, "route": { "zh": "口服（标签产品身份字段）", "en": "oral (label product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 24979-243-07", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片 40 mg；90 片瓶装", "en": "40 mg per tablet; 90-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=40mg.jpg&setid=838c2d78-d2d8-4981-9ec9-e50ef9e1a5d8&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "赖诺普利", "en": "lisinopril" }, "value": 40, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、疗程或换算", "en": "labelled amount per tablet; not an individual's tablet count, course or conversion" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 90, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-04", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 90, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "黄色", "en": "yellow" }, "shape": { "zh": "圆形、双凸、无包衣，约 8 mm", "en": "round, biconvex and uncoated, about 8 mm" }, "imprint": "ZESTRIL 40 / 134", "scoreStatus": "unscored_do_not_split", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_218b6a32d18c5ea6", "label": "DailyMed（NLM）：ZESTRIL 赖诺普利当前美国公开标签（Upsher-Smith；2024-11 修订；2025-05-05 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=838c2d78-d2d8-4981-9ec9-e50ef9e1a5d8", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-zestril-lisinopril-tablet-10mg-90bottle-ndc-24979-240-07", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=label-10-90.jpg&setid=838c2d78-d2d8-4981-9ec9-e50ef9e1a5d8&type=img", "alt": { "zh": "DailyMed 当前 ZESTRIL 10 mg、NDC 24979-240-07、90 片瓶装标签面板", "en": "Current DailyMed ZESTRIL 10 mg, NDC 24979-240-07, 90-tablet bottle label panel" }, "archiveMarket": "美国", "labelVersion": "DailyMed 当前美国公开标签（2024-11 修订；2025-05-05 发布）", "presentation": "ZESTRIL 赖诺普利：每片 10 mg，NDC 24979-240-07，90 片瓶装。", "notice": "此图只对应美国 DailyMed 公开标签中的 ZESTRIL、赖诺普利、每片 10 mg、NDC 24979-240-07 与 90 片瓶装。它只帮助核对品牌、通用名、每片标签量、包装数量和来源；不用于鉴定真伪，也不证明其他规格、其他包装、其他市场、当前可得性、原研身份、可替代性，或任何个人的片数、时间、开始、停用、联用或换药方案。", "source": { "id": "src_218b6a32d18c5ea6", "label": "DailyMed（NLM）：ZESTRIL 赖诺普利当前美国公开标签（Upsher-Smith；2024-11 修订；2025-05-05 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=838c2d78-d2d8-4981-9ec9-e50ef9e1a5d8", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "ZESTRIL 说明书放大阅读：每片 mg 是身份，不是“该吃几片”", "en": "ZESTRIL label reading: mg per tablet identifies a product; it does not answer “how many tablets”" }, "summary": { "zh": "本模块只阅读 DailyMed 美国标签中的 ZESTRIL、赖诺普利、口服片、每片标示量、NDC 与黑框警告。它不提供个人片数、起止时间、联用、换药或购买方案。", "en": "This module reads only ZESTRIL, lisinopril, oral tablets, labelled amount per tablet, NDCs and the boxed warning in the U.S. DailyMed label. It provides no individual tablet count, start/stop timing, co-use, switching or purchase plan." }, "checks": [ { "zh": "先把 ZESTRIL、赖诺普利、口服片、每片 2.5／5／10／20／30／40 mg、NDC、实际包装和目标市场一起核对。mg 是一片准确产品的标示量，不是网页可以换算成个人每天该用多少片的规则，也不能据此把其他规格、剂型、市场或另一种药自行互换。", "en": "Check ZESTRIL, lisinopril, oral-tablet form, the stated 2.5/5/10/20/30/40 mg per tablet, NDC, actual pack and target market together. Mg is the labelled amount in an exact tablet, not a web rule for how many tablets an individual should use, and it cannot self-convert another strength, form, market or medicine." }, { "zh": "该标签含妊娠相关黑框警告。怀孕、可能怀孕、备孕或哺乳相关疑问，不能仅根据药盒、网页或他人经验自行处理；应尽快联系开方团队或药师，并以手中准确产品和所在市场的现行标签核对。", "en": "The label carries a pregnancy-related boxed warning. Questions about pregnancy, possible pregnancy, family planning or breastfeeding cannot be handled from a pack, webpage or another person's experience; contact the prescribing team or pharmacist promptly and check the exact product and current target-market label." }, { "zh": "标签将肾功能、血钾、血压、血管性水肿及与利尿剂、非甾体抗炎药、锂盐、mTOR 或脑啡肽酶抑制剂等的关系列为需要专业复核的安全线索。新增处方药、非处方止痛/感冒药、草本、补充剂或盐替代品时，请携带完整药单和实际包装请药师或医疗团队核对；不要自行叠加、替换或改变用法。", "en": "The label identifies kidney function, potassium, blood pressure, angioedema, and relationships with diuretics, NSAIDs, lithium, mTOR inhibitors or neprilysin inhibitors as safety cues requiring professional review. When adding a prescription, OTC pain/cold product, herb, supplement or salt substitute, have a pharmacist or care team check the complete medicine list and actual packs; do not self-combine, replace or alter use." }, { "zh": "ZESTRIL 是单方赖诺普利；ZESTORETIC 已含赖诺普利和氢氯噻嗪。当前标签还明确与沙库巴曲/缬沙坦切换前后存在 36 小时边界。两个名称同时出现或准备换用 ENTRESTO 时，不要依据网页自行加药、停药或安排间隔，应及时联系开方团队或药师。", "en": "ZESTRIL contains lisinopril alone; ZESTORETIC already contains lisinopril and hydrochlorothiazide. The current label also states a 36-hour boundary around switching to or from sacubitril/valsartan. If both names appear or a switch involving ENTRESTO is planned, do not add, stop or schedule an interval from the website; contact the prescriber or pharmacist promptly." }, { "zh": "当前美国标签只有 5 mg 片列为有刻痕，其余五个规格列为无刻痕。有刻痕只是准确产品的外观字段，不表示任何人都可以掰；是否能掰、掰后如何使用仍须按实际处方、现行本地说明书和药师判断。", "en": "Only the 5 mg tablet is listed as scored in the current U.S. label; the other five strengths are unscored. A score is an exact-product appearance field, not permission for everyone to split; whether and how it may be split still requires the actual prescription, current local label and pharmacist review." }, { "zh": "出现呼吸困难、面部/口唇/咽喉肿胀、晕厥或其他急性严重不适时，应优先使用当地紧急医疗渠道。此页面不能替代现场评估，也不建议根据页面自行开始、停用、补用或换药。", "en": "With breathing difficulty, swelling of the face, lips or throat, fainting or another acute serious concern, prioritise local emergency care. This page cannot replace in-person assessment and does not direct self-starting, stopping, make-up use or switching." } ], "source": { "id": "src_218b6a32d18c5ea6", "label": "DailyMed（NLM）：ZESTRIL 赖诺普利当前美国公开标签（Upsher-Smith；2024-11 修订；片剂身份、黑框警告与相互作用）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=838c2d78-d2d8-4981-9ec9-e50ef9e1a5d8", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "赖诺普利怎样起作用：标签所述 ACE 抑制路径", "en": "How lisinopril works: the ACE-inhibition pathway described in the label" }, "summary": { "zh": "美国 ZESTRIL 标签将赖诺普利归为血管紧张素转换酶（ACE）抑制剂。这个机制帮助理解药物类别和标签警示；它不判断个人血压、心衰症状、肾功能、适用性、片数或任何联用方案。", "en": "The U.S. ZESTRIL label identifies lisinopril as an angiotensin-converting enzyme (ACE) inhibitor. This mechanism helps read drug class and label warnings; it does not determine an individual's blood pressure, heart-failure symptoms, kidney function, suitability, tablet count or any combination plan." }, "checks": [ { "zh": "“ACE 抑制剂”是药理类别，不表示同类产品可以自行叠加、轮换或按 mg 对等换算。名称、剂型、肾功能、血钾、其他药物和实际目标市场标签都需要逐项核对。", "en": "“ACE inhibitor” is a pharmacologic class; it does not establish that related products can be self-combined, alternated or milligram-converted. Name, dosage form, kidney function, potassium, other medicines and the actual target-market label all need item-by-item review." }, { "zh": "看到“降压”“心衰”或同类机制文字，也不能证明两盒产品可以互换，或能回答个人是否适合。需要变更治疗、出现不适或准备加入其他产品时，应先由了解完整药单的专业人员审阅。", "en": "Shared words such as “blood pressure,” “heart failure” or a mechanism class do not establish that two packs can be exchanged or answer individual suitability. Before changing treatment, with a concern, or before adding another product, obtain review from a professional with the complete medicine list." }, { "zh": "机制说明不能替代药物警戒、相互作用或紧急评估。出现急性严重不适时优先使用当地紧急医疗渠道；其余疑问请携带实际包装和完整药单联系药师或开方团队。", "en": "Mechanism information does not replace pharmacovigilance, interaction review or emergency assessment. Use local emergency care first for an acute serious concern; for other questions, contact a pharmacist or prescribing team with the actual pack and complete medicine list." } ], "source": { "id": "src_218b6a32d18c5ea6", "label": "DailyMed（NLM）：ZESTRIL 赖诺普利当前美国公开标签（Upsher-Smith；2024-11 修订；Clinical Pharmacology）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=838c2d78-d2d8-4981-9ec9-e50ef9e1a5d8", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "ZESTRIL", "generic": "赖诺普利", "dosageFormClass": "口服片：2.5 mg、5 mg、10 mg、20 mg、30 mg、40 mg（DailyMed 美国公开标签所列）" }, "labelSource": { "id": "src_218b6a32d18c5ea6", "label": "DailyMed（NLM）：ZESTRIL 赖诺普利当前美国公开标签（Upsher-Smith；2024-11 修订；2025-05-05 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=838c2d78-d2d8-4981-9ec9-e50ef9e1a5d8", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" }, "productRoutes": [ { "source": { "id": "src_218b6a32d18c5ea6", "label": "DailyMed（NLM）：ZESTRIL 赖诺普利当前美国公开标签（Upsher-Smith；2024-11 修订；2025-05-05 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=838c2d78-d2d8-4981-9ec9-e50ef9e1a5d8", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-09-04", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-09-04", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "DailyMed 当前美国标签将 ZESTRIL 列为赖诺普利口服片，并列出 2.5、5、10、20、30、40 mg 的每片标示量、六个 NDC、包装面板和片剂外观。mg 不是一次该吃几片；当前标签只有 5 mg 片列为有刻痕，而刻痕也不是网页发出的掰片许可。若药单同时出现 ZESTORETIC、其他赖诺普利或 ENTRESTO，应让药师或开方团队逐盒核对成分和特殊时间边界，不要自行叠加、轮换或停药。", "history": "FDA 审评资料记录赖诺普利片于 1987 年以 PRINIVIL 首次获批，ZESTRIL 片于 1988 年以 NDA 019777 获批。当前 DailyMed ZESTRIL 标签修订于 2024-11、现行页面版本发布于 2025-05-05。当前分销信息与历史申请主体不能混写成同一家公司连续持有；不同剂型、包装、市场或同通用名产品也必须分别核对。", "sourceDocuments": [ { "id": "src_218b6a32d18c5ea6", "label": "DailyMed（NLM）：ZESTRIL 赖诺普利当前美国公开标签（Upsher-Smith；2024-11 修订；2025-05-05 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=838c2d78-d2d8-4981-9ec9-e50ef9e1a5d8", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" }, { "id": "src_5f7d5caf7bf6f1c3", "label": "FDA：赖诺普利口服液审评中的历史说明（1987 年 PRINIVIL、1988 年 ZESTRIL）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/208401Orig1s000OtherR.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_regulatory_record", "documentKind": "regulatory_review", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_pdf", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" } ], "applicationNumber": "FDA NDA 019777 (ZESTRIL lisinopril oral tablets)", "approvalTimeline": [ { "date": "1988", "title": { "zh": "FDA 标签所列美国初始批准年份", "en": "Initial U.S. approval year listed in the FDA label" }, "detail": { "zh": "本页链接的 FDA 标签档案列示 Initial U.S. Approval: 1988。该历史定位不等同于当前批准、可得性、持有人或其他市场状态。", "en": "The FDA label archive linked here lists Initial U.S. Approval: 1988. This historical locator is not a conclusion about current approval, availability, holder or another market." }, "source": { "id": "src_218b6a32d18c5ea6", "label": "DailyMed: current ZESTRIL lisinopril U.S. public label", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=838c2d78-d2d8-4981-9ec9-e50ef9e1a5d8", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" } }, { "date": "2024-11 (current DailyMed revision; published 2025-05-05)", "title": { "zh": "FDA 标签档案版本", "en": "FDA label archive version" }, "detail": { "zh": "本页链接 2024-11 (current DailyMed revision; published 2025-05-05) 的 FDA 标签档案作为可复核阅读入口。现行标签、规格、适应症和安全信息必须另行以目标市场当前文件核对。", "en": "This page links the 2024-11 (current DailyMed revision; published 2025-05-05) FDA label archive as a traceable reading entry point. Current labeling, strength, indication and safety information require separate verification against the target market’s current document." }, "source": { "id": "src_218b6a32d18c5ea6", "label": "DailyMed: current ZESTRIL lisinopril U.S. public label", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=838c2d78-d2d8-4981-9ec9-e50ef9e1a5d8", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "已链接公开标签档案", "en": "Public label archive linked" }, "detail": { "zh": "仅对应本页所列 FDA 文件。", "en": "Only the FDA document listed on this page is linked." } }, { "market": { "zh": "中国大陆、欧盟、日本", "en": "Mainland China, EU, Japan" }, "status": { "zh": "待逐项建立市场记录", "en": "Market record not established" }, "detail": { "zh": "不从美国标签档案推定当地批准、持有人、规格、供应或可售资格。", "en": "No local approval, holder, strength, supply or sale-eligibility conclusion is inferred from the U.S. label archive." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "标签档案能代表现在的产品信息吗？", "en": "Does a label archive represent current product information?" }, "answer": { "zh": "不能自动代表。档案用于定位来源；需要以目标市场的现行官方标签逐项复核。", "en": "Not automatically. The archive locates a source; each point needs verification against the target market’s current official label." } }, { "question": { "zh": "为什么这里不展示价格或原研/仿制结论？", "en": "Why are price and originator/generic conclusions not shown?" }, "answer": { "zh": "这些结论需要产品、剂型、规格、包装、市场、日期和原始记录分别齐全并经人工审核；单一标签文件不足以支持。", "en": "Those conclusions require separately complete and human-reviewed product, dosage-form, strength, pack, market, date and primary-record fields; one label file is insufficient." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "how-to-read-a-drug-label", "regulatory-sources-first" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/zestril/", "en": "https://origindrug.com/en/drugs/zestril/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "capoten", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-28", "status": "published_traceable_archive" }, "names": { "brand": "CAPOTEN", "generic": "卡托普利", "aliases": [ "CAPOTEN", "captopril", "卡托普利", "开博通", "NDA 018343", "018343" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": { "value": "开博通", "status": "discovery_cue_requires_target_market_verification", "source": { "id": "src_27ece1a130f52a0d", "label": "深圳市市场监督管理局：外包装易混淆药物示例中的卡托普利片（开博通）12.5 mg×20 片（DB4403/T 140—2021，历史药盒线索）", "url": "https://amr.sz.gov.cn/attachment/0/745/745335/9772236.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "regulatory_guidance", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" } } }, "identity": { "therapeuticArea": "心血管", "sourceArchiveMarket": "美国 CAPOTEN（captopril）NDA 018343 历史原品牌记录与 2015 历史标签；美国当前卡托普利通用名标签；中国大陆 2021 年官方标准中的开博通 12.5 mg×20 片历史药盒线索", "dosageFormClass": "CAPOTEN 历史口服刻痕片：12.5、25、50、100 mg；美国当前卡托普利通用名标签同样列出 12.5、25、50、100 mg；中国历史药盒线索为 12.5 mg×20 片", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "1981-04-06（FDA NDA 018343 原始批准）", "archiveSponsorText": "E. R. Squibb and Sons / Squibb 研发历史；FDA 当前 NDA 记录与 2015 CAPOTEN 历史标签；当前持有人、供应和各市场状态须另行核验" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [ "captopril and hydrochlorothiazide", "卡托普利氢氯噻嗪", "复方卡托普利", "CAPOZIDE" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-capoten-captopril-12-5mg-scored-tablet-historical-2015", "marketCode": "US", "labelVersion": { "zh": "FDA CAPOTEN 美国历史标签（2015；非当前供应或包装结论）", "en": "FDA U.S. historical CAPOTEN label (2015; not a current supply or package finding)" }, "dosageForm": { "zh": "CAPOTEN 卡托普利刻痕口服片", "en": "CAPOTEN captopril scored oral tablet" }, "route": { "zh": "口服（历史标签产品身份字段）", "en": "oral (historical-label product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDA 018343 historical label text identity; exact NDC/package panel not established", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片卡托普利 12.5 mg；刻痕片（美国 2015 历史标签；未建立准确包装量）", "en": "Captopril 12.5 mg per tablet; scored tablet (2015 U.S. historical label; exact pack count not established)" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "卡托普利", "en": "captopril" }, "value": 12.5, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片历史标签标示量；不是个人片数、频率或掰片指令", "en": "historical labelled amount per tablet; not an individual's tablet count, frequency or splitting instruction" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-28", "currentLabelDisplayed": false, "ndcDirectoryListed": false, "marketAvailability": "historical_discontinued_brand", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": null, "physicalClues": { "color": null, "shape": { "zh": "标签称为刻痕片；未保留可准确对应的官方原品牌包装图", "en": "labelled as scored; no exact official original-brand package image retained" }, "imprint": null, "scoreStatus": "scored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_3178bcb743e4d743", "label": "FDA：CAPOTEN 卡托普利 12.5 mg 刻痕口服片（2015 美国历史标签）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018343s086lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-capoten-captopril-25mg-scored-tablet-historical-2015", "marketCode": "US", "labelVersion": { "zh": "FDA CAPOTEN 美国历史标签（2015；非当前供应或包装结论）", "en": "FDA U.S. historical CAPOTEN label (2015; not a current supply or package finding)" }, "dosageForm": { "zh": "CAPOTEN 卡托普利刻痕口服片", "en": "CAPOTEN captopril scored oral tablet" }, "route": { "zh": "口服（历史标签产品身份字段）", "en": "oral (historical-label product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDA 018343 historical label text identity; exact NDC/package panel not established", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片卡托普利 25 mg；刻痕片（美国 2015 历史标签；未建立准确包装量）", "en": "Captopril 25 mg per tablet; scored tablet (2015 U.S. historical label; exact pack count not established)" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "卡托普利", "en": "captopril" }, "value": 25, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片历史标签标示量；不是个人片数、频率或掰片指令", "en": "historical labelled amount per tablet; not an individual's tablet count, frequency or splitting instruction" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-28", "currentLabelDisplayed": false, "ndcDirectoryListed": false, "marketAvailability": "historical_discontinued_brand", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": null, "physicalClues": { "color": null, "shape": { "zh": "标签称为刻痕片；未保留可准确对应的官方原品牌包装图", "en": "labelled as scored; no exact official original-brand package image retained" }, "imprint": null, "scoreStatus": "scored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_3178bcb743e4d743", "label": "FDA：CAPOTEN 卡托普利 25 mg 刻痕口服片（2015 美国历史标签）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018343s086lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-capoten-captopril-50mg-scored-tablet-historical-2015", "marketCode": "US", "labelVersion": { "zh": "FDA CAPOTEN 美国历史标签（2015；非当前供应或包装结论）", "en": "FDA U.S. historical CAPOTEN label (2015; not a current supply or package finding)" }, "dosageForm": { "zh": "CAPOTEN 卡托普利刻痕口服片", "en": "CAPOTEN captopril scored oral tablet" }, "route": { "zh": "口服（历史标签产品身份字段）", "en": "oral (historical-label product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDA 018343 historical label text identity; exact NDC/package panel not established", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片卡托普利 50 mg；刻痕片（美国 2015 历史标签；未建立准确包装量）", "en": "Captopril 50 mg per tablet; scored tablet (2015 U.S. historical label; exact pack count not established)" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "卡托普利", "en": "captopril" }, "value": 50, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片历史标签标示量；不是个人片数、频率或掰片指令", "en": "historical labelled amount per tablet; not an individual's tablet count, frequency or splitting instruction" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-28", "currentLabelDisplayed": false, "ndcDirectoryListed": false, "marketAvailability": "historical_discontinued_brand", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": null, "physicalClues": { "color": null, "shape": { "zh": "标签称为刻痕片；未保留可准确对应的官方原品牌包装图", "en": "labelled as scored; no exact official original-brand package image retained" }, "imprint": null, "scoreStatus": "scored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_3178bcb743e4d743", "label": "FDA：CAPOTEN 卡托普利 50 mg 刻痕口服片（2015 美国历史标签）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018343s086lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-capoten-captopril-100mg-scored-tablet-historical-2015", "marketCode": "US", "labelVersion": { "zh": "FDA CAPOTEN 美国历史标签（2015；非当前供应或包装结论）", "en": "FDA U.S. historical CAPOTEN label (2015; not a current supply or package finding)" }, "dosageForm": { "zh": "CAPOTEN 卡托普利刻痕口服片", "en": "CAPOTEN captopril scored oral tablet" }, "route": { "zh": "口服（历史标签产品身份字段）", "en": "oral (historical-label product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDA 018343 historical label text identity; exact NDC/package panel not established", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片卡托普利 100 mg；刻痕片（美国 2015 历史标签；未建立准确包装量）", "en": "Captopril 100 mg per tablet; scored tablet (2015 U.S. historical label; exact pack count not established)" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "卡托普利", "en": "captopril" }, "value": 100, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片历史标签标示量；不是个人片数、频率或掰片指令", "en": "historical labelled amount per tablet; not an individual's tablet count, frequency or splitting instruction" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-28", "currentLabelDisplayed": false, "ndcDirectoryListed": false, "marketAvailability": "historical_discontinued_brand", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": null, "physicalClues": { "color": null, "shape": { "zh": "标签称为刻痕片；未保留可准确对应的官方原品牌包装图", "en": "labelled as scored; no exact official original-brand package image retained" }, "imprint": null, "scoreStatus": "scored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_3178bcb743e4d743", "label": "FDA：CAPOTEN 卡托普利 100 mg 刻痕口服片（2015 美国历史标签）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018343s086lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "cn-kai-bo-tong-captopril-12-5mg-20tablets-historical-pack-cue-2021", "marketCode": "CN", "labelVersion": { "zh": "深圳市市场监督管理局 DB4403/T 140—2021 历史药盒示例；非当前批准或供应结论", "en": "Historical pack example in Shenzhen market-regulator standard DB4403/T 140—2021; not a current approval or supply finding" }, "dosageForm": { "zh": "开博通 卡托普利片（历史药盒线索）", "en": "Kaibotong captopril tablet (historical pack cue)" }, "route": { "zh": "口服（历史药盒文字线索）", "en": "oral (historical pack-text cue)" }, "routeCodes": [ "oral" ], "productCode": "Current approval number not established from the cited official standard", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "开博通 卡托普利片：每片 12.5 mg，20 片包装（2021 官方标准历史示例）", "en": "Kaibotong captopril tablets: 12.5 mg per tablet, 20-tablet pack (historical 2021 official-standard example)" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "卡托普利", "en": "captopril" }, "value": 12.5, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "历史药盒所列每片含量；不是个人片数或当前产品结论", "en": "amount per tablet shown on a historical pack; not an individual tablet count or current-product finding" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-28", "currentLabelDisplayed": false, "ndcDirectoryListed": false, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 20, "unit": { "zh": "片/盒（历史示例）", "en": "tablets per pack (historical example)" } }, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_27ece1a130f52a0d", "label": "深圳市市场监督管理局：卡托普利片（开博通）12.5 mg×20 片历史药盒示例（DB4403/T 140—2021）", "url": "https://amr.sz.gov.cn/attachment/0/745/745335/9772236.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "regulatory_guidance", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "status": "withheld_repackaged_or_non_exact_visual", "title": { "zh": "已核验 CAPOTEN 历史标签与中国历史药盒线索，但未保留可对应当前原品牌的官方包装图，故不展示包装图片", "en": "Historical CAPOTEN label and Chinese pack cues were reviewed, but no official image matching a current original-brand pack was retained, so no package visual is shown" }, "summary": { "zh": "FDA 当前申请记录将 CAPOTEN 品牌规格标为停产；2015 历史标签提供四种刻痕片文字身份，深圳市场监管局 2021 年标准提供“开博通”12.5 mg×20 片历史药盒示例。为避免把历史示意图、零售图、当前通用名包装或其他厂家图片误作现行 CAPOTEN 原品牌外观，页面不展示包装图片，只保留来源、文字身份和历史边界。", "en": "The current FDA application record marks CAPOTEN brand strengths discontinued; the 2015 historical label provides text identities for four scored tablets, and a 2021 Shenzhen market-regulator standard provides a historical Kaibotong 12.5 mg × 20-tablet pack example. To avoid presenting a historical illustration, retail image, current generic pack or another manufacturer's image as current CAPOTEN original-brand appearance, the dossier withholds package imagery and retains source, text identity and historical boundaries." }, "source": { "id": "src_65a94ca75de5d133", "label": "FDA Drugs@FDA：CAPOTEN（captopril）NDA 018343 当前申请记录", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=018343", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "CAPOTEN／开博通／卡托普利说明书放大阅读：先分清历史品牌、通用名和每片毫克数", "en": "CAPOTEN/captopril label reading: separate the historical brand, generic name and milligrams per tablet" }, "summary": { "zh": "本模块把 FDA 的 CAPOTEN 历史原品牌标签、当前卡托普利通用名标签和中国“开博通”历史药盒线索分开呈现。12.5、25、50、100 mg 都是每片标示强度，不是网页给出的个人片数；品牌停产也不等于所有卡托普利产品停产。", "en": "This module separates the FDA historical original-brand CAPOTEN label, a current generic captopril label and the historical Chinese Kaibotong pack cue. 12.5, 25, 50 and 100 mg are strengths per tablet, not personal tablet counts generated by the site; brand discontinuation does not mean every captopril product is discontinued." }, "checks": [ { "zh": "先读完整药盒：CAPOTEN／开博通是历史品牌线索，卡托普利是通用名；同时核对市场、每片强度、是否复方、现行说明书和处方。不要把复方卡托普利或另一种 ACE 抑制剂当作同一盒药。", "en": "Read the whole pack first: CAPOTEN/Kaibotong are historical brand cues and captopril is the generic name. Also check market, strength per tablet, whether it is a combination, the current label and prescription. Do not treat a captopril combination or another ACE inhibitor as the same product." }, { "zh": "标签中的 12.5、25、50、100 mg 表示每片卡托普利含量；它们不能脱离处方、肾功能、血压、电解质、其他药物和用药时间自行换算成片数。", "en": "The 12.5, 25, 50 and 100 mg figures state captopril per tablet; they cannot be converted into a tablet count without the prescription, kidney function, blood pressure, electrolytes, other medicines and timing." }, { "zh": "历史标签写有刻痕，不代表每一种现售卡托普利片都可自行掰开，也不代表半片就适合个人。必须核对手中准确厂家和说明书，并由药师或医生确认。", "en": "A score in the historical label does not mean every currently marketed captopril tablet may be self-split, or that half a tablet suits an individual. Check the exact manufacturer and label in hand and confirm with a pharmacist or clinician." }, { "zh": "把止痛药（尤其 NSAIDs）、利尿药、补钾或含钾盐替代品、其他降压药和全部非处方药放进同一张药单。老人、脱水或肾功能受损者同时使用 NSAID 与 ACE 抑制剂时，FDA 历史标签提示肾功能恶化风险；网页不能替代逐项相互作用复核。", "en": "Put pain medicines (especially NSAIDs), diuretics, potassium supplements or potassium-containing salt substitutes, other blood-pressure medicines and all OTC products on one list. The FDA historical label warns that older, volume-depleted or renally impaired people using an NSAID with an ACE inhibitor may have worsened kidney function; the site cannot replace item-by-item interaction review." }, { "zh": "面部、嘴唇、舌头或喉部肿胀、呼吸或吞咽困难可能是严重血管性水肿，应立即使用当地急救服务；不要等待网页判断，也不要自行补服或换药。", "en": "Swelling of the face, lips, tongue or throat, or breathing/swallowing difficulty may be serious angioedema. Use local emergency services immediately; do not wait for a webpage decision or self-redose/switch." } ], "source": { "id": "src_3178bcb743e4d743", "label": "FDA：CAPOTEN（captopril）2015 美国历史处方信息", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018343s086lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "卡托普利怎样起作用：抑制 ACE，减少血管紧张素 II 的形成", "en": "How captopril works: ACE inhibition reduces formation of angiotensin II" }, "summary": { "zh": "FDA 标签将卡托普利描述为血管紧张素转换酶（ACE）抑制剂。ACE 参与把血管紧张素 I 转换为血管紧张素 II；后者会收缩血管并促进醛固酮分泌。抑制这条路径可解释血压、血管阻力和钾相关监测为何重要，但不能预测个人反应或决定用量。", "en": "The FDA label describes captopril as an angiotensin-converting-enzyme (ACE) inhibitor. ACE helps convert angiotensin I to angiotensin II, which constricts blood vessels and stimulates aldosterone secretion. Inhibiting this pathway helps explain why blood pressure, vascular resistance and potassium-related monitoring matter, but does not predict individual response or determine an amount." }, "checks": [ { "zh": "“同为降压药”不表示卡托普利能与赖诺普利、缬沙坦、氯沙坦、沙库巴曲/缬沙坦或含利尿剂复方自行叠加、隔日轮换或按毫克换算。", "en": "Being blood-pressure medicines does not make captopril self-combinable, alternate-day interchangeable or milligram-convertible with lisinopril, valsartan, losartan, sacubitril/valsartan or a diuretic combination." }, { "zh": "ACE、肾素、醛固酮等机制词不能替代血压、肾功能、电解质和完整药单的专业判断，也不能成为自行停药或加量的理由。", "en": "Mechanism terms such as ACE, renin and aldosterone do not replace professional review of blood pressure, kidney function, electrolytes and the complete medicine list, and are not a reason for self-stopping or increasing." }, { "zh": "持续干咳、头晕、乏力、排尿变化或其他新症状需要结合实际产品和个体情况评估；若出现面舌喉肿胀、呼吸困难、晕厥或其他严重急性问题，应立即使用当地急救支持。", "en": "Persistent cough, dizziness, weakness, urine change or another new symptom needs review in the context of the exact product and individual. Face/tongue/throat swelling, breathing trouble, fainting or another severe acute problem requires immediate local emergency support." } ], "source": { "id": "src_664e7f95450c5009", "label": "DailyMed（NLM）：卡托普利当前美国通用名公开标签（2024-12-27 更新；临床药理）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=607687f4-63cf-411c-a20b-21d238a6b7a7", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "CAPOTEN", "generic": "卡托普利", "dosageFormClass": "CAPOTEN 历史口服刻痕片：12.5、25、50、100 mg；美国当前卡托普利通用名标签同样列出 12.5、25、50、100 mg；中国历史药盒线索为 12.5 mg×20 片" }, "labelSource": { "id": "src_3178bcb743e4d743", "label": "FDA：CAPOTEN（captopril）2015 美国历史处方信息", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018343s086lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" }, "productRoutes": [ { "source": { "id": "src_3178bcb743e4d743", "label": "FDA：CAPOTEN（captopril）2015 美国历史处方信息", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018343s086lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" }, "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-08-28", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_65a94ca75de5d133", "label": "FDA Drugs@FDA：CAPOTEN（captopril）NDA 018343 当前申请记录", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=018343", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" }, "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-08-28", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_664e7f95450c5009", "label": "DailyMed（NLM）：卡托普利当前美国通用名公开标签（Hikma；2024-12-27 更新；ANDA）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=607687f4-63cf-411c-a20b-21d238a6b7a7", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-28", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-08-28", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "CAPOTEN 是卡托普利的美国历史原品牌档案。FDA NDA 018343 记录可追溯到 1981 年原始批准，2015 年历史标签列出 12.5、25、50、100 mg 刻痕口服片；当前 FDA 申请记录显示品牌规格已停产。页面另链接当前卡托普利通用名标签和中国“开博通”历史药盒线索，帮助老人先分清品牌、通用名、每片毫克数、复方药与市场版本，不生成个人片数、频次或换药方案。", "history": "卡托普利由 Squibb 研究人员开发，是早期口服血管紧张素转换酶（ACE）抑制剂。FDA NDA 018343 于 1981-04-06 获原始批准；2015 年 CAPOTEN 历史标签仍列出四种刻痕片。FDA 当前申请记录将这些品牌规格标为 discontinued，并保留“并非因安全性或有效性原因撤市”的说明。中国深圳市场监管局 2021 年官方标准以 12.5 mg×20 片的“开博通”作为历史药盒易混淆示例；该图文只用于名称和包装历史核对，不代表当前批准、供应或真伪认证。", "sourceDocuments": [ { "id": "src_65a94ca75de5d133", "label": "FDA Drugs@FDA：CAPOTEN（captopril）NDA 018343 当前申请记录", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=018343", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" }, { "id": "src_3178bcb743e4d743", "label": "FDA：CAPOTEN（captopril）2015 美国历史处方信息", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018343s086lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" }, { "id": "src_664e7f95450c5009", "label": "DailyMed（NLM）：卡托普利当前美国通用名公开标签（Hikma；2024-12-27 更新；ANDA）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=607687f4-63cf-411c-a20b-21d238a6b7a7", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" }, { "id": "src_27ece1a130f52a0d", "label": "深圳市市场监督管理局：卡托普利片（开博通）12.5 mg×20 片历史药盒示例（DB4403/T 140—2021）", "url": "https://amr.sz.gov.cn/attachment/0/745/745335/9772236.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "regulatory_guidance", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" } ], "applicationNumber": "FDA NDA 018343（CAPOTEN / captopril；美国原品牌历史档案）", "approvalTimeline": [ { "date": "1981-04-06", "title": { "zh": "FDA 批准 CAPOTEN NDA 018343 原始申请", "en": "FDA approved the original CAPOTEN NDA 018343" }, "detail": { "zh": "FDA Drugs@FDA 当前申请数据将 CAPOTEN、captopril、NDA 018343 与 1981-04-06 的 ORIG 1 批准节点连接。该节点建立美国原品牌历史，不自动建立中国大陆或其他市场的批准、品牌、包装、供应或可替代性。", "en": "Current FDA Drugs@FDA application data link CAPOTEN, captopril, NDA 018343 and the ORIG 1 approval node dated 6 Apr 1981. This establishes U.S. original-brand history; it does not automatically establish approval, branding, packaging, supply or interchangeability in Mainland China or another market." }, "source": { "id": "src_65a94ca75de5d133", "label": "FDA Drugs@FDA：CAPOTEN（captopril）NDA 018343 当前申请记录", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=018343", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" } }, { "date": "2015-05", "title": { "zh": "CAPOTEN 历史标签列出四种刻痕口服片", "en": "Historical CAPOTEN label lists four scored oral-tablet strengths" }, "detail": { "zh": "FDA 2015 历史标签列出 12.5、25、50、100 mg 刻痕口服片，并明确提醒该文件可能不是最新获批标签。本页据此建立有日期的说明书阅读，而不是当前供应或包装结论。", "en": "The FDA 2015 historical label lists 12.5, 25, 50 and 100 mg scored oral tablets and explicitly warns that the document may not be the latest approved label. The dossier uses it as a dated label-reading record, not a current supply or package finding." }, "source": { "id": "src_3178bcb743e4d743", "label": "FDA：CAPOTEN（captopril）2015 美国历史处方信息", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018343s086lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" } }, { "date": "2024-12-27", "title": { "zh": "当前卡托普利通用名标签更新", "en": "Current generic captopril label updated" }, "detail": { "zh": "DailyMed 当前 Hikma 卡托普利标签于 2024-12-27 更新，营销状态为 ANDA 通用名产品。它用于读取现行成分、强度、警示与相互作用，不把通用名包装误作 CAPOTEN 原品牌包装。", "en": "The current Hikma captopril label on DailyMed was updated 27 Dec 2024 and is marketed under an ANDA. It supports current ingredient, strength, warning and interaction reading without treating a generic pack as CAPOTEN original-brand packaging." }, "source": { "id": "src_664e7f95450c5009", "label": "DailyMed（NLM）：卡托普利当前美国通用名公开标签（Hikma；2024-12-27 更新；ANDA）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=607687f4-63cf-411c-a20b-21d238a6b7a7", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "原品牌历史已核验；CAPOTEN 品牌规格在当前 FDA 记录中标为停产", "en": "Original-brand history verified; CAPOTEN strengths are marked discontinued in the current FDA record" }, "detail": { "zh": "FDA 当前申请记录同时保留“并非因安全性或有效性原因撤市”的说明。本页链接 NDA 历史和 2015 历史标签，并另列当前通用名标签；不把历史品牌写成今天仍有库存、可购买或适合个人使用。", "en": "The current FDA application record also retains the statement that discontinuation was not for safety or effectiveness reasons. This dossier links the NDA history and 2015 historical label and separately lists a current generic label; it does not present the historical brand as currently stocked, purchasable or individually suitable." } }, { "market": { "zh": "中国大陆", "en": "Mainland China" }, "status": { "zh": "仅建立“开博通”12.5 mg×20 片历史药盒线索", "en": "Historical Kaibotong 12.5 mg × 20-tablet pack cue only" }, "detail": { "zh": "深圳市场监管局 2021 年官方标准将其列为外包装易混淆药物示例。该资料支持名称、每片强度、包装量和历史生产企业文字核对，不建立当前批准文号、持有人、供应、原研/仿制关系、真伪或可替代性。", "en": "A 2021 Shenzhen market-regulator standard lists it as a confusing-package example. The material supports checking the name, strength per tablet, pack count and historical manufacturer wording; it does not establish a current approval number, holder, supply, originator/generic relationship, authenticity or interchangeability." } }, { "market": { "zh": "欧盟、日本及其他市场", "en": "European Union, Japan and other markets" }, "status": { "zh": "待逐项建立现行市场记录", "en": "Current market record not established" }, "detail": { "zh": "不从美国 CAPOTEN 历史、卡托普利通用名、共同 ACE 抑制机制或中国历史药盒推定当地品牌、批准、包装、供应、可售资格或可替代性。", "en": "No local brand, approval, package, supply, sale eligibility or interchangeability is inferred from U.S. CAPOTEN history, the captopril generic name, shared ACE-inhibitor mechanism or the historical Chinese pack." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "CAPOTEN 已停产，是否表示卡托普利不能用了？", "en": "Does CAPOTEN discontinuation mean captopril can no longer be used?" }, "answer": { "zh": "不能这样推断。FDA 当前记录描述的是 CAPOTEN 这一美国品牌规格的营销状态，并注明并非因安全性或有效性原因撤市；DailyMed 仍有当前卡托普利通用名标签。是否存在、获批、供应或适合个人，必须按目标市场和准确产品另行核对。", "en": "No. The current FDA record describes the marketing status of U.S. CAPOTEN brand strengths and says discontinuation was not for safety or effectiveness reasons; DailyMed still provides a current generic captopril label. Existence, approval, supply and individual suitability require separate checking for the target market and exact product." } }, { "question": { "zh": "片上有刻痕，是否可以掰半就等于减半？", "en": "If the tablet is scored, can it simply be split to make half an amount?" }, "answer": { "zh": "网页不能据此给个人结论。历史 CAPOTEN 标签的刻痕只描述该历史产品；手中产品的厂家、剂型、强度、刻痕用途、处方和个人情况都要核对。不要把历史品牌标签或网络图片用于当前另一厂家产品的掰片决定。", "en": "The site cannot make that individual decision. The score in the historical CAPOTEN label describes that historical product; the manufacturer, dosage form, strength, purpose of the score, prescription and individual context for the product in hand all need checking. Do not use a historical brand label or web image to decide splitting for another current manufacturer's product." } }, { "question": { "zh": "药单里还有布洛芬、利尿药、缬沙坦或补钾，可以一起用吗？", "en": "Can captopril be used with ibuprofen, a diuretic, valsartan or potassium on the medicine list?" }, "answer": { "zh": "网页不能判断个人能否同用。这些名称提示需要把全部处方药、非处方止痛药、补充剂、含钾盐替代品、肾功能、电解质和血压一起交给药师或开方团队核对；不要自行叠加、停用、错开或替换。", "en": "The site cannot decide individual co-use. These names signal that all prescriptions, OTC pain medicines, supplements, potassium-containing salt substitutes, kidney function, electrolytes and blood pressure need review together by a pharmacist or prescriber; do not self-combine, stop, separate or substitute." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "dosage-forms-are-part-of-medicine-identity", "how-to-read-a-drug-label" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/capoten/", "en": "https://origindrug.com/en/drugs/capoten/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "vasotec", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-28", "status": "published_traceable_archive" }, "names": { "brand": "VASOTEC", "generic": "依那普利", "aliases": [ "VASOTEC", "enalapril", "enalapril maleate", "依那普利", "马来酸依那普利", "NDA 018998", "VASO 2.5", "VASO 5", "VASO 10", "VASO 20", "018998" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "心血管", "sourceArchiveMarket": "美国 VASOTEC（enalapril maleate）NDA 018998 原品牌监管历史与 DailyMed 2026-01-23 当前公开标签", "dosageFormClass": "VASOTEC 马来酸依那普利口服刻痕片：2.5、5、10、20 mg；所引当前美国标签另含药师配制 1 mg/mL 混悬液的专业说明，但本档案不把该段转换成家庭配制或个人用量指令", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "1985-12-24（FDA NDA 018998 原始批准）", "archiveSponsorText": "Merck Sharp & Dohme 原始申请历史；DailyMed 当前标签列示 Bausch Health US LLC；持有人、供应和其他市场状态须按现行监管记录另行核验" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [ "enalaprilat injection", "VASOTEC I.V.", "VASERETIC", "enalapril and hydrochlorothiazide", "依那普利氢氯噻嗪", "复方依那普利" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-vasotec-enalapril-maleate-2-5mg-30-tablet-bottle-ndc-0187014030", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v15（2026-01-23 生效）", "en": "DailyMed SPL v15 (effective 23 Jan 2026)" }, "dosageForm": { "zh": "VASOTEC 马来酸依那普利刻痕口服片", "en": "VASOTEC enalapril maleate scored oral tablet" }, "route": { "zh": "口服（标签产品身份字段）", "en": "oral (label product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 0187-0140-30", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片马来酸依那普利 2.5 mg；NDC 0187-0140-30；30 片瓶装", "en": "Enalapril maleate 2.5 mg per tablet; NDC 0187-0140-30; 30-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=image-01.jpg&setid=39631f1f-5d19-43c1-b504-bf56d991ed97&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "马来酸依那普利", "en": "enalapril maleate" }, "value": 2.5, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、频率或换算指令", "en": "labelled amount per tablet; not an individual's tablet count, frequency or conversion instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "片", "en": "tablets" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-28", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 30, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "白色", "en": "white" }, "shape": { "zh": "椭圆形；有刻痕（外观线索不是个人掰片许可）", "en": "oval; scored (an appearance clue, not personal permission to split)" }, "imprint": "VASO 2.5", "scoreStatus": "scored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_58048ae417506148", "label": "DailyMed（NLM）：VASOTEC 马来酸依那普利 2.5 mg、30 片瓶装美国公开标签面板", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=39631f1f-5d19-43c1-b504-bf56d991ed97", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-vasotec-enalapril-maleate-5mg-30-tablet-bottle-ndc-0187014130", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v15（2026-01-23 生效）", "en": "DailyMed SPL v15 (effective 23 Jan 2026)" }, "dosageForm": { "zh": "VASOTEC 马来酸依那普利刻痕口服片", "en": "VASOTEC enalapril maleate scored oral tablet" }, "route": { "zh": "口服（标签产品身份字段）", "en": "oral (label product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 0187-0141-30", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片马来酸依那普利 5 mg；NDC 0187-0141-30；30 片瓶装", "en": "Enalapril maleate 5 mg per tablet; NDC 0187-0141-30; 30-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=image-02.jpg&setid=39631f1f-5d19-43c1-b504-bf56d991ed97&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "马来酸依那普利", "en": "enalapril maleate" }, "value": 5, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、频率或换算指令", "en": "labelled amount per tablet; not an individual's tablet count, frequency or conversion instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "片", "en": "tablets" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-28", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 30, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "白色", "en": "white" }, "shape": { "zh": "圆角三角形；有刻痕（外观线索不是个人掰片许可）", "en": "rounded triangular; scored (an appearance clue, not personal permission to split)" }, "imprint": "VASO 5", "scoreStatus": "scored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_58048ae417506148", "label": "DailyMed（NLM）：VASOTEC 马来酸依那普利 5 mg、30 片瓶装美国公开标签面板", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=39631f1f-5d19-43c1-b504-bf56d991ed97", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-vasotec-enalapril-maleate-10mg-30-tablet-bottle-ndc-0187014230", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v15（2026-01-23 生效）", "en": "DailyMed SPL v15 (effective 23 Jan 2026)" }, "dosageForm": { "zh": "VASOTEC 马来酸依那普利刻痕口服片", "en": "VASOTEC enalapril maleate scored oral tablet" }, "route": { "zh": "口服（标签产品身份字段）", "en": "oral (label product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 0187-0142-30", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片马来酸依那普利 10 mg；NDC 0187-0142-30；30 片瓶装", "en": "Enalapril maleate 10 mg per tablet; NDC 0187-0142-30; 30-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=image-03.jpg&setid=39631f1f-5d19-43c1-b504-bf56d991ed97&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "马来酸依那普利", "en": "enalapril maleate" }, "value": 10, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、频率或换算指令", "en": "labelled amount per tablet; not an individual's tablet count, frequency or conversion instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "片", "en": "tablets" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-28", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 30, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "铁锈红色", "en": "rust red" }, "shape": { "zh": "圆角三角形；有刻痕（外观线索不是个人掰片许可）", "en": "rounded triangular; scored (an appearance clue, not personal permission to split)" }, "imprint": "VASO 10", "scoreStatus": "scored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_58048ae417506148", "label": "DailyMed（NLM）：VASOTEC 马来酸依那普利 10 mg、30 片瓶装美国公开标签面板", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=39631f1f-5d19-43c1-b504-bf56d991ed97", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-vasotec-enalapril-maleate-20mg-30-tablet-bottle-ndc-0187014330", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v15（2026-01-23 生效）", "en": "DailyMed SPL v15 (effective 23 Jan 2026)" }, "dosageForm": { "zh": "VASOTEC 马来酸依那普利刻痕口服片", "en": "VASOTEC enalapril maleate scored oral tablet" }, "route": { "zh": "口服（标签产品身份字段）", "en": "oral (label product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 0187-0143-30", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片马来酸依那普利 20 mg；NDC 0187-0143-30；30 片瓶装", "en": "Enalapril maleate 20 mg per tablet; NDC 0187-0143-30; 30-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=image-04.jpg&setid=39631f1f-5d19-43c1-b504-bf56d991ed97&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "马来酸依那普利", "en": "enalapril maleate" }, "value": 20, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、频率或换算指令", "en": "labelled amount per tablet; not an individual's tablet count, frequency or conversion instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "片", "en": "tablets" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-28", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 30, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "桃色", "en": "peach" }, "shape": { "zh": "圆角三角形；有刻痕（外观线索不是个人掰片许可）", "en": "rounded triangular; scored (an appearance clue, not personal permission to split)" }, "imprint": "VASO 20", "scoreStatus": "scored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_58048ae417506148", "label": "DailyMed（NLM）：VASOTEC 马来酸依那普利 20 mg、30 片瓶装美国公开标签面板", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=39631f1f-5d19-43c1-b504-bf56d991ed97", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-vasotec-enalapril-maleate-10mg-30-tablet-bottle-ndc-0187014230", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=image-03.jpg&setid=39631f1f-5d19-43c1-b504-bf56d991ed97&type=img", "alt": "VASOTEC 马来酸依那普利在美国 DailyMed 当前标签中的 10 mg、NDC 0187-0142-30、30 片瓶装展示面", "archiveMarket": "美国", "labelVersion": "DailyMed SPL v15（2026-01-23 生效）", "presentation": "VASOTEC 马来酸依那普利：每片 10 mg，NDC 0187-0142-30，30 片瓶装展示面。", "notice": "此图只对应美国 DailyMed 当前标签中的 VASOTEC、马来酸依那普利 10 mg、NDC 0187-0142-30 与 30 片瓶装。它只帮助核对商品名、通用名、每片标示量、片剂、包装数量、VASO 10 刻印与来源；不用于鉴定真伪，也不证明 2.5/5/20 mg、90/1,000 片包装、配制混悬液、其他市场、实时库存、原研身份、可替代性，或任何个人的片数、频率、掰片、停药、联用或换药方案。", "source": { "id": "src_58048ae417506148", "label": "DailyMed（NLM）：VASOTEC 马来酸依那普利 10 mg、30 片瓶装美国公开标签面板", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=39631f1f-5d19-43c1-b504-bf56d991ed97", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "VASOTEC／依那普利说明书放大阅读：先看每片毫克数，再核对整张药单", "en": "VASOTEC/enalapril label reading: check milligrams per tablet, then review the whole medicine list" }, "summary": { "zh": "当前美国标签把 VASOTEC 列为马来酸依那普利 2.5、5、10、20 mg 刻痕片。mg 是每片标示量，不是网页给出的个人片数；刻痕、同属降压药或相近毫克数也不能建立自行掰片、叠加、隔日轮换或换药。", "en": "The current U.S. label lists VASOTEC as scored enalapril maleate tablets in 2.5, 5, 10 and 20 mg strengths. mg is the labelled amount per tablet, not a personal tablet count generated by the site; a score, shared blood-pressure purpose or nearby milligram number does not establish self-splitting, combining, alternate-day use or switching." }, "checks": [ { "zh": "先同时核对 VASOTEC、马来酸依那普利、口服片、2.5/5/10/20 mg、NDC、刻印和目标市场。不要把依那普利注射剂、依那普利/氢氯噻嗪复方、赖诺普利、卡托普利或沙坦类当成同一盒药。", "en": "Check VASOTEC, enalapril maleate, oral tablet, 2.5/5/10/20 mg, NDC, imprint and target market together. Do not treat enalaprilat injection, an enalapril/hydrochlorothiazide combination, lisinopril, captopril or an ARB as the same product." }, { "zh": "2.5、5、10、20 mg 都表示每片标示量；个人用量还要结合处方、血压、肾功能、钾、年龄、脱水情况和其他药物，网页不能把一个规格换算成几片或一日总量。", "en": "2.5, 5, 10 and 20 mg each state a labelled amount per tablet. Individual use also depends on the prescription, blood pressure, kidney function, potassium, age, volume status and other medicines; the site cannot convert a strength into a tablet count or daily total." }, { "zh": "标签写有刻痕并不等于任何人都应掰开，也不表示另一厂家依那普利片的刻痕用途相同。先核对手中准确产品、处方和现行说明书，再请药师或开方团队确认。", "en": "A score in the label does not mean everyone should split the tablet or that another manufacturer's enalapril score has the same purpose. Check the exact product, prescription and current label in hand, then confirm with a pharmacist or prescriber." }, { "zh": "把利尿药、补钾、含钾盐替代品、布洛芬/萘普生等 NSAIDs、锂、其他 ACE 抑制剂、沙坦类和沙库巴曲/缬沙坦放在同一张药单里复核。不要自行叠加、错开、隔日轮换、停用或替换。", "en": "Place diuretics, potassium supplements, potassium-containing salt substitutes, NSAIDs such as ibuprofen/naproxen, lithium, other ACE inhibitors, ARBs and sacubitril/valsartan on one list for review. Do not self-combine, separate, alternate by day, stop or substitute." }, { "zh": "面部、嘴唇、舌头或喉部肿胀，呼吸或吞咽困难，昏厥或其他严重急性问题需要立即使用当地急救服务；不要等待网页判断。怀孕或可能怀孕也应尽快联系开方团队，因为美国标签含胎儿毒性加框警示。", "en": "Swelling of the face, lips, tongue or throat, breathing or swallowing difficulty, fainting or another severe acute problem requires immediate local emergency help; do not wait for a website decision. Pregnancy or possible pregnancy also requires prompt contact with the prescribing team because the U.S. label carries a boxed warning for fetal toxicity." } ], "source": { "id": "src_58048ae417506148", "label": "DailyMed（NLM）：VASOTEC 马来酸依那普利当前美国公开标签（Bausch Health；SPL v15）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=39631f1f-5d19-43c1-b504-bf56d991ed97", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "依那普利怎样起作用：前体药转化为依那普利拉，再抑制 ACE", "en": "How enalapril works: a prodrug converted to enalaprilat, then ACE inhibition" }, "summary": { "zh": "当前标签说明依那普利是前体药，口服后水解为活性 ACE 抑制剂依那普利拉。抑制 ACE 会减少血管紧张素 II 的形成和醛固酮分泌，帮助理解血压、肾功能、钾与相互作用为何要一起监测；它不能预测个人反应或决定用量。", "en": "The current label explains that enalapril is a prodrug hydrolysed after oral use to the active ACE inhibitor enalaprilat. ACE inhibition reduces formation of angiotensin II and aldosterone secretion, helping explain why blood pressure, kidney function, potassium and interactions are reviewed together; it cannot predict individual response or determine an amount." }, "checks": [ { "zh": "同属 ACE 抑制剂不表示依那普利可与卡托普利或赖诺普利自行合用、按毫克换算或隔日轮换；与沙坦类或沙库巴曲/缬沙坦也必须按准确药物和现行标签逐项核对。", "en": "Sharing the ACE-inhibitor class does not make enalapril self-combinable, milligram-convertible or alternate-day interchangeable with captopril or lisinopril; ARBs and sacubitril/valsartan also require exact medicine- and current-label review." }, { "zh": "干咳、头晕、乏力、排尿变化或检查异常不能仅凭机制归因，也不能成为自行停药、补服或改用另一种降压药的理由；请带实际药盒和完整药单联系专业人员。", "en": "Dry cough, dizziness, weakness, urine change or an abnormal test cannot be attributed from mechanism alone and is not a reason to self-stop, redose or change to another blood-pressure medicine; take the actual pack and complete medicine list to a professional." }, { "zh": "机制词不能替代血压、肾功能、电解质、妊娠状态和完整药单的临床判断；若有面舌喉肿胀、呼吸困难、昏厥或其他严重急性问题，应立即使用当地急救支持。", "en": "Mechanism terms do not replace clinical review of blood pressure, kidney function, electrolytes, pregnancy status and the complete medicine list. Face/tongue/throat swelling, breathing difficulty, fainting or another severe acute problem requires immediate local emergency support." } ], "source": { "id": "src_58048ae417506148", "label": "DailyMed（NLM）：VASOTEC 当前美国公开标签（临床药理与作用机制）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=39631f1f-5d19-43c1-b504-bf56d991ed97", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "VASOTEC", "generic": "依那普利", "dosageFormClass": "VASOTEC 马来酸依那普利口服刻痕片：2.5、5、10、20 mg；所引当前美国标签另含药师配制 1 mg/mL 混悬液的专业说明，但本档案不把该段转换成家庭配制或个人用量指令" }, "labelSource": { "id": "src_58048ae417506148", "label": "DailyMed（NLM）：VASOTEC 马来酸依那普利当前美国公开标签（Bausch Health；SPL v15，2026-01-23 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=39631f1f-5d19-43c1-b504-bf56d991ed97", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" }, "productRoutes": [ { "source": { "id": "src_58048ae417506148", "label": "DailyMed（NLM）：VASOTEC 马来酸依那普利当前美国公开标签（Bausch Health；SPL v15，2026-01-23 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=39631f1f-5d19-43c1-b504-bf56d991ed97", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-28", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_17772ae97ea9f6ad", "label": "FDA Drugs@FDA：VASOTEC（enalapril maleate）NDA 018998 当前申请记录", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=018998", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" }, "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-08-28", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-28", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "VASOTEC 是马来酸依那普利的美国原品牌档案。当前美国公开标签列出 2.5、5、10、20 mg 四种口服刻痕片，并附准确 NDC、片剂颜色/形状/刻印和瓶装展示面。页面优先帮助老人分清品牌、通用名、每片毫克数、ACE 抑制剂与复方药，理解咳嗽、高钾、肾功能、低血压和血管性水肿等标签警示；不生成个人片数、频率、掰片、停药、联用或换药方案。", "history": "FDA 资料将 VASOTEC 的片剂原始批准日期记录为 1985-12-24，申请号为 NDA 018998。DailyMed 当前 SPL v15 于 2026-01-23 生效，列示 Bausch Health US LLC、2.5/5/10/20 mg 片、四类 30/90 片瓶装和部分 1,000 片瓶装。网页把原始批准历史、当前美国标签与其他市场未核验边界分开，不用美国商品名或包装推断全球供应。", "sourceDocuments": [ { "id": "src_17772ae97ea9f6ad", "label": "FDA Drugs@FDA：VASOTEC（enalapril maleate）NDA 018998 当前申请记录", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=018998", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" }, { "id": "src_58048ae417506148", "label": "DailyMed（NLM）：VASOTEC 马来酸依那普利当前美国公开标签（Bausch Health；SPL v15，2026-01-23 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=39631f1f-5d19-43c1-b504-bf56d991ed97", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" } ], "applicationNumber": "FDA NDA 018998（VASOTEC / enalapril maleate；美国原品牌监管档案）", "approvalTimeline": [ { "date": "1985-12-24", "title": { "zh": "VASOTEC 片剂美国原始批准", "en": "Original U.S. approval of VASOTEC tablets" }, "detail": { "zh": "FDA 审评资料将 VASOTEC NDA 018998 列为依那普利马来酸盐片的 reference listed drug，并记录片剂于 1985-12-24 最初获批。该历史节点只建立美国产品史，不自动建立其他市场的品牌、批准、供应或可替代性。", "en": "FDA review material identifies VASOTEC NDA 018998 as the reference listed drug for enalapril maleate tablets and records initial tablet approval on 24 Dec 1985. This historical node establishes U.S. product history only and does not automatically establish another market's brand, approval, supply or interchangeability." }, "source": { "id": "src_17772ae97ea9f6ad", "label": "FDA Drugs@FDA：VASOTEC（enalapril maleate）NDA 018998 当前申请记录", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=018998", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" } }, { "date": "2026-01-23", "title": { "zh": "当前美国 VASOTEC SPL v15 生效", "en": "Current U.S. VASOTEC SPL v15 effective" }, "detail": { "zh": "DailyMed 当前标签列示 VASOTEC、NDA018998、Bausch Health US LLC、2.5/5/10/20 mg 刻痕片、准确 NDC、片剂外观和瓶装展示面。页面把标签版本与实时库存、购买和个人适用性分开。", "en": "The current DailyMed label lists VASOTEC, NDA018998, Bausch Health US LLC, scored 2.5/5/10/20 mg tablets, exact NDCs, tablet appearance and bottle display panels. The page keeps label version separate from live stock, purchase and individual suitability." }, "source": { "id": "src_58048ae417506148", "label": "DailyMed（NLM）：VASOTEC 马来酸依那普利当前美国公开标签（SPL v15）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=39631f1f-5d19-43c1-b504-bf56d991ed97", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "当前 NDA 品牌标签和四种 30 片瓶装展示面已链接", "en": "Current NDA brand label and four 30-tablet bottle panels linked" }, "detail": { "zh": "分别记录 2.5、5、10、20 mg 的 NDC、颜色、形状、VASO 刻印、刻痕与来源；不用于鉴定真伪，也不建立实时库存、购买、个人片数、频率、掰片、停用、联用或换药方案。", "en": "Separately records NDC, colour, shape, VASO imprint, score and source for 2.5, 5, 10 and 20 mg. It does not authenticate a product or establish live stock, purchase, individual tablet count, frequency, splitting, stopping, co-use or switching." } }, { "market": { "zh": "中国大陆、欧盟、日本及其他市场", "en": "Mainland China, the EU, Japan and other markets" }, "status": { "zh": "待逐项建立现行监管产品记录", "en": "Current regulatory product record not established" }, "detail": { "zh": "不从美国 VASOTEC 名称、NDA、共同通用名、NDC、毫克数、刻印或包装图推定当地商品名、批准、包装、供应、原研/参比关系或可替代性；每个市场须按当地现行监管资料逐产品核对。", "en": "No local trade name, approval, packaging, supply, originator/reference relationship or interchangeability is inferred from the U.S. VASOTEC name, NDA, shared generic name, NDC, milligram value, imprint or package image; each product requires current local regulatory review." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "VASOTEC、依那普利、卡托普利和赖诺普利是一回事吗？", "en": "Are VASOTEC, enalapril, captopril and lisinopril the same thing?" }, "answer": { "zh": "VASOTEC 是所引美国依那普利产品的商品名，依那普利是通用名；卡托普利和赖诺普利是不同成分。即使都属于 ACE 抑制剂，也不能据此自行叠加、轮换、按毫克换算或替代。请用实际药盒、处方和完整药单由药师或开方团队核对。", "en": "VASOTEC is the trade name of the cited U.S. enalapril product, while enalapril is the generic name; captopril and lisinopril are different ingredients. Even though all are ACE inhibitors, that does not support self-combining, alternating, milligram conversion or substitution. Have a pharmacist or prescriber review the actual packs, prescription and complete medicine list." } }, { "question": { "zh": "VASOTEC 片上有刻痕，能否掰半就等于减半？", "en": "VASOTEC tablets are scored; can splitting simply make half an amount?" }, "answer": { "zh": "网页不能据刻痕给个人结论。所引美国标签描述的是四个准确 VASOTEC 展示面；刻痕不等于人人都应分片，也不证明另一厂家产品有相同用途。请先核对手中准确产品、处方和现行说明书，再由药师或医生确认。", "en": "The site cannot make an individual decision from a score. The cited U.S. label describes four exact VASOTEC presentations; a score does not mean everyone should split a tablet or prove that another manufacturer's product has the same purpose. Check the exact product, prescription and current label in hand, then confirm with a pharmacist or clinician." } }, { "question": { "zh": "药单里已有缬沙坦、氯沙坦、沙库巴曲/缬沙坦、利尿药、布洛芬或补钾，能一起用吗？", "en": "Can VASOTEC be used with valsartan, losartan, sacubitril/valsartan, a diuretic, ibuprofen or potassium?" }, "answer": { "zh": "网页不能判断个人能否同用。这些名称提示需要把全部处方药、非处方止痛药、补充剂、盐替代品、血压、肾功能和电解质一起交给药师或开方团队逐项核对；不要自行叠加、错开、隔日轮换、停用或替换。", "en": "The site cannot decide individual co-use. These names signal that all prescriptions, OTC pain medicines, supplements, salt substitutes, blood pressure, kidney function and electrolytes need item-by-item review by a pharmacist or prescriber; do not self-combine, separate, alternate by day, stop or substitute." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "dosage-forms-are-part-of-medicine-identity", "how-to-read-a-drug-label" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/vasotec/", "en": "https://origindrug.com/en/drugs/vasotec/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "coumadin", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-22", "status": "published_traceable_archive" }, "names": { "brand": "Coumadin", "generic": "华法林钠", "aliases": [ "warfarin", "warfarin sodium" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "抗凝与血液", "sourceArchiveMarket": "美国公开监管档案（FDA 2015 历史标签；文件明确可能不是最新获批标签）", "dosageFormClass": "多种剂型（口服片剂及静脉注射用制剂；FDA 2015 历史标签所列；本页精确展示 9 个口服片 100 片瓶装身份及 1 个注射用 6 瓶纸盒身份）", "dosageFormClassCode": "multiple_forms_and_routes", "route": "口服 / 静脉注射", "routeCode": "multiple", "historicalApprovalEntry": "1954（FDA 2015 标签所列美国初始批准）", "archiveSponsorText": "FDA 公开监管档案" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [ "NDC 54868-2128-3", "Aphena Pharma Solutions" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-coumadin-warfarin-historical-tablet-1mg-ndc-0056-0169-70", "marketCode": "US", "labelVersion": { "zh": "FDA 美国历史标签（2015-10 修订；可能不是最新获批标签）", "en": "FDA U.S. historical label (revised Oct 2015; may not be the latest approved label)" }, "dosageForm": { "zh": "华法林钠单刻痕口服片（历史标签）", "en": "warfarin sodium single-scored oral tablet (historical label)" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 0056-0169-70", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片华法林钠 1 mg；100 片瓶装（历史标签文字）", "en": "Warfarin sodium 1 mg per tablet; 100-tablet bottle (historical label text)" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "华法林钠", "en": "warfarin sodium" }, "value": 1, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片历史标签标示量；不是个人片数、INR 调整、补用或换算指令", "en": "historical labelled amount per tablet; not an individual tablet count, INR adjustment, make-up-use or conversion instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": null, "package": { "count": 100, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "粉红色", "en": "pink" }, "shape": { "zh": "单刻痕片", "en": "single-scored tablet" }, "imprint": { "zh": "COUMADIN / 1（一面）；另一面空白", "en": "COUMADIN / 1 (one face); plain opposite face" }, "scoreStatus": "scored_status_not_a_split_instruction", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_acac1255f20ea439", "label": "FDA：COUMADIN 美国历史标签（NDA 009218；2015-10 修订；口服片包装文字）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/009218s115lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-coumadin-warfarin-historical-tablet-2mg-ndc-0056-0170-70", "marketCode": "US", "labelVersion": { "zh": "FDA 美国历史标签（2015-10 修订；可能不是最新获批标签）", "en": "FDA U.S. historical label (revised Oct 2015; may not be the latest approved label)" }, "dosageForm": { "zh": "华法林钠单刻痕口服片（历史标签）", "en": "warfarin sodium single-scored oral tablet (historical label)" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 0056-0170-70", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片华法林钠 2 mg；100 片瓶装（历史标签文字）", "en": "Warfarin sodium 2 mg per tablet; 100-tablet bottle (historical label text)" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "华法林钠", "en": "warfarin sodium" }, "value": 2, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片历史标签标示量；不是个人片数、INR 调整、补用或换算指令", "en": "historical labelled amount per tablet; not an individual tablet count, INR adjustment, make-up-use or conversion instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": null, "package": { "count": 100, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "淡紫色", "en": "lavender" }, "shape": { "zh": "单刻痕片", "en": "single-scored tablet" }, "imprint": { "zh": "COUMADIN / 2（一面）；另一面空白", "en": "COUMADIN / 2 (one face); plain opposite face" }, "scoreStatus": "scored_status_not_a_split_instruction", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_acac1255f20ea439", "label": "FDA：COUMADIN 美国历史标签（NDA 009218；2015-10 修订；口服片包装文字）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/009218s115lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-coumadin-warfarin-historical-tablet-2-5mg-ndc-0056-0176-70", "marketCode": "US", "labelVersion": { "zh": "FDA 美国历史标签（2015-10 修订；可能不是最新获批标签）", "en": "FDA U.S. historical label (revised Oct 2015; may not be the latest approved label)" }, "dosageForm": { "zh": "华法林钠单刻痕口服片（历史标签）", "en": "warfarin sodium single-scored oral tablet (historical label)" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 0056-0176-70", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片华法林钠 2.5 mg；100 片瓶装（历史标签文字）", "en": "Warfarin sodium 2.5 mg per tablet; 100-tablet bottle (historical label text)" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "华法林钠", "en": "warfarin sodium" }, "value": 2.5, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片历史标签标示量；不是个人片数、INR 调整、补用或换算指令", "en": "historical labelled amount per tablet; not an individual tablet count, INR adjustment, make-up-use or conversion instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": null, "package": { "count": 100, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "绿色", "en": "green" }, "shape": { "zh": "单刻痕片", "en": "single-scored tablet" }, "imprint": { "zh": "COUMADIN / 2-1/2（一面）；另一面空白", "en": "COUMADIN / 2-1/2 (one face); plain opposite face" }, "scoreStatus": "scored_status_not_a_split_instruction", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_acac1255f20ea439", "label": "FDA：COUMADIN 美国历史标签（NDA 009218；2015-10 修订；口服片包装文字）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/009218s115lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-coumadin-warfarin-historical-tablet-3mg-ndc-0056-0188-70", "marketCode": "US", "labelVersion": { "zh": "FDA 美国历史标签（2015-10 修订；可能不是最新获批标签）", "en": "FDA U.S. historical label (revised Oct 2015; may not be the latest approved label)" }, "dosageForm": { "zh": "华法林钠单刻痕口服片（历史标签）", "en": "warfarin sodium single-scored oral tablet (historical label)" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 0056-0188-70", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片华法林钠 3 mg；100 片瓶装（历史标签文字）", "en": "Warfarin sodium 3 mg per tablet; 100-tablet bottle (historical label text)" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "华法林钠", "en": "warfarin sodium" }, "value": 3, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片历史标签标示量；不是个人片数、INR 调整、补用或换算指令", "en": "historical labelled amount per tablet; not an individual tablet count, INR adjustment, make-up-use or conversion instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": null, "package": { "count": 100, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "棕褐色", "en": "tan" }, "shape": { "zh": "单刻痕片", "en": "single-scored tablet" }, "imprint": { "zh": "COUMADIN / 3（一面）；另一面空白", "en": "COUMADIN / 3 (one face); plain opposite face" }, "scoreStatus": "scored_status_not_a_split_instruction", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_acac1255f20ea439", "label": "FDA：COUMADIN 美国历史标签（NDA 009218；2015-10 修订；口服片包装文字）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/009218s115lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-coumadin-warfarin-historical-tablet-4mg-ndc-0056-0168-70", "marketCode": "US", "labelVersion": { "zh": "FDA 美国历史标签（2015-10 修订；可能不是最新获批标签）", "en": "FDA U.S. historical label (revised Oct 2015; may not be the latest approved label)" }, "dosageForm": { "zh": "华法林钠单刻痕口服片（历史标签）", "en": "warfarin sodium single-scored oral tablet (historical label)" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 0056-0168-70", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片华法林钠 4 mg；100 片瓶装（历史标签文字）", "en": "Warfarin sodium 4 mg per tablet; 100-tablet bottle (historical label text)" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "华法林钠", "en": "warfarin sodium" }, "value": 4, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片历史标签标示量；不是个人片数、INR 调整、补用或换算指令", "en": "historical labelled amount per tablet; not an individual tablet count, INR adjustment, make-up-use or conversion instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": null, "package": { "count": 100, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "蓝色", "en": "blue" }, "shape": { "zh": "单刻痕片", "en": "single-scored tablet" }, "imprint": { "zh": "COUMADIN / 4（一面）；另一面空白", "en": "COUMADIN / 4 (one face); plain opposite face" }, "scoreStatus": "scored_status_not_a_split_instruction", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_acac1255f20ea439", "label": "FDA：COUMADIN 美国历史标签（NDA 009218；2015-10 修订；口服片包装文字）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/009218s115lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-coumadin-warfarin-historical-tablet-5mg-ndc-0056-0172-70", "marketCode": "US", "labelVersion": { "zh": "FDA 美国历史标签（2015-10 修订；可能不是最新获批标签）", "en": "FDA U.S. historical label (revised Oct 2015; may not be the latest approved label)" }, "dosageForm": { "zh": "华法林钠单刻痕口服片（历史标签）", "en": "warfarin sodium single-scored oral tablet (historical label)" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 0056-0172-70", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片华法林钠 5 mg；100 片瓶装（历史标签文字）", "en": "Warfarin sodium 5 mg per tablet; 100-tablet bottle (historical label text)" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "华法林钠", "en": "warfarin sodium" }, "value": 5, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片历史标签标示量；不是个人片数、INR 调整、补用或换算指令", "en": "historical labelled amount per tablet; not an individual tablet count, INR adjustment, make-up-use or conversion instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": null, "package": { "count": 100, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "桃色", "en": "peach" }, "shape": { "zh": "单刻痕片", "en": "single-scored tablet" }, "imprint": { "zh": "COUMADIN / 5（一面）；另一面空白", "en": "COUMADIN / 5 (one face); plain opposite face" }, "scoreStatus": "scored_status_not_a_split_instruction", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_acac1255f20ea439", "label": "FDA：COUMADIN 美国历史标签（NDA 009218；2015-10 修订；口服片包装文字）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/009218s115lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-coumadin-warfarin-historical-tablet-6mg-ndc-0056-0189-70", "marketCode": "US", "labelVersion": { "zh": "FDA 美国历史标签（2015-10 修订；可能不是最新获批标签）", "en": "FDA U.S. historical label (revised Oct 2015; may not be the latest approved label)" }, "dosageForm": { "zh": "华法林钠单刻痕口服片（历史标签）", "en": "warfarin sodium single-scored oral tablet (historical label)" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 0056-0189-70", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片华法林钠 6 mg；100 片瓶装（历史标签文字）", "en": "Warfarin sodium 6 mg per tablet; 100-tablet bottle (historical label text)" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "华法林钠", "en": "warfarin sodium" }, "value": 6, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片历史标签标示量；不是个人片数、INR 调整、补用或换算指令", "en": "historical labelled amount per tablet; not an individual tablet count, INR adjustment, make-up-use or conversion instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": null, "package": { "count": 100, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "蓝绿色", "en": "teal" }, "shape": { "zh": "单刻痕片", "en": "single-scored tablet" }, "imprint": { "zh": "COUMADIN / 6（一面）；另一面空白", "en": "COUMADIN / 6 (one face); plain opposite face" }, "scoreStatus": "scored_status_not_a_split_instruction", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_acac1255f20ea439", "label": "FDA：COUMADIN 美国历史标签（NDA 009218；2015-10 修订；口服片包装文字）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/009218s115lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-coumadin-warfarin-historical-tablet-7-5mg-ndc-0056-0173-70", "marketCode": "US", "labelVersion": { "zh": "FDA 美国历史标签（2015-10 修订；可能不是最新获批标签）", "en": "FDA U.S. historical label (revised Oct 2015; may not be the latest approved label)" }, "dosageForm": { "zh": "华法林钠单刻痕口服片（历史标签）", "en": "warfarin sodium single-scored oral tablet (historical label)" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 0056-0173-70", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片华法林钠 7.5 mg；100 片瓶装（历史标签文字）", "en": "Warfarin sodium 7.5 mg per tablet; 100-tablet bottle (historical label text)" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "华法林钠", "en": "warfarin sodium" }, "value": 7.5, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片历史标签标示量；不是个人片数、INR 调整、补用或换算指令", "en": "historical labelled amount per tablet; not an individual tablet count, INR adjustment, make-up-use or conversion instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": null, "package": { "count": 100, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "黄色", "en": "yellow" }, "shape": { "zh": "单刻痕片", "en": "single-scored tablet" }, "imprint": { "zh": "COUMADIN / 7-1/2（一面）；另一面空白", "en": "COUMADIN / 7-1/2 (one face); plain opposite face" }, "scoreStatus": "scored_status_not_a_split_instruction", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_acac1255f20ea439", "label": "FDA：COUMADIN 美国历史标签（NDA 009218；2015-10 修订；口服片包装文字）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/009218s115lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-coumadin-warfarin-historical-tablet-10mg-ndc-0056-0174-70", "marketCode": "US", "labelVersion": { "zh": "FDA 美国历史标签（2015-10 修订；可能不是最新获批标签）", "en": "FDA U.S. historical label (revised Oct 2015; may not be the latest approved label)" }, "dosageForm": { "zh": "华法林钠单刻痕口服片（历史标签）", "en": "warfarin sodium single-scored oral tablet (historical label)" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 0056-0174-70", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片华法林钠 10 mg；100 片瓶装（历史标签文字）", "en": "Warfarin sodium 10 mg per tablet; 100-tablet bottle (historical label text)" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "华法林钠", "en": "warfarin sodium" }, "value": 10, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片历史标签标示量；不是个人片数、INR 调整、补用或换算指令", "en": "historical labelled amount per tablet; not an individual tablet count, INR adjustment, make-up-use or conversion instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": null, "package": { "count": 100, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "白色（无色素）", "en": "white (dye-free)" }, "shape": { "zh": "单刻痕片", "en": "single-scored tablet" }, "imprint": { "zh": "COUMADIN / 10（一面）；另一面空白", "en": "COUMADIN / 10 (one face); plain opposite face" }, "scoreStatus": "scored_status_not_a_split_instruction", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_acac1255f20ea439", "label": "FDA：COUMADIN 美国历史标签（NDA 009218；2015-10 修订；口服片包装文字）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/009218s115lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-coumadin-warfarin-historical-injection-5mg-vial-carton6-ndc-0590-0324-35", "marketCode": "US", "labelVersion": { "zh": "FDA 美国历史标签（2015-10 修订；可能不是最新获批标签）", "en": "FDA U.S. historical label (revised Oct 2015; may not be the latest approved label)" }, "dosageForm": { "zh": "华法林钠静脉注射用冻干粉（历史标签）", "en": "warfarin sodium lyophilized powder for intravenous injection (historical label)" }, "route": { "zh": "静脉注射（仅作标签身份字段）", "en": "intravenous injection (label identity only)" }, "routeCodes": [ "intravenous" ], "productCode": "NDC 0590-0324-35", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_vial", "primaryDisplay": { "zh": "每瓶华法林钠 5 mg；6 瓶纸盒（历史标签文字）", "en": "Warfarin sodium 5 mg per vial; carton of 6 vials (historical label text)" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "华法林钠", "en": "warfarin sodium" }, "value": 5, "unit": "mg", "basisCode": "per_vial", "basisLabel": { "zh": "每瓶历史标签标示量；不是个人注射量、复溶、给药速度、调整或转换指令", "en": "historical labelled amount per vial; not an individual injection amount, reconstitution, administration-rate, adjustment or conversion instruction" } } ], "concentration": null, "container": { "typeCode": "vial_carton", "typeLabel": { "zh": "小瓶纸盒", "en": "vial carton" }, "fill": null, "countPerPackage": 6, "countUnit": { "zh": "瓶/盒", "en": "vials per carton" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": null, "package": { "count": 6, "unit": { "zh": "瓶/盒", "en": "vials per carton" } }, "physicalClues": { "color": null, "shape": { "zh": "小瓶（历史标签文字）", "en": "vial (historical label text)" }, "imprint": null, "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_acac1255f20ea439", "label": "FDA：COUMADIN 美国历史标签（NDA 009218；2015-10 修订；静脉注射用制剂包装文字）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/009218s115lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "status": "withheld_repackaged_or_non_exact_visual", "title": { "zh": "已核验到再包装历史标签，故不展示为原品牌包装", "en": "A repackaged historical label was located, so it is not shown as an original-brand package" }, "summary": { "zh": "DailyMed 可检索到的 COUMADIN 历史记录标示为再包装标签。它可用于追溯商品名、华法林钠、1 mg、90 片和历史 NDC 54868-2128-3，却不能作为本页的准确原品牌包装图。为避免把再包装标签误读为原品牌外观，本档案不展示该图，只保留公开标签作为文字核验入口。", "en": "The searchable historical DailyMed COUMADIN record is identified as repackaged. It can trace the trade name, warfarin sodium, 1 mg, 90 tablets and historical NDC 54868-2128-3, but cannot be presented as this record's exact original-brand package image. To avoid treating a repackaged label as original-brand appearance, this dossier withholds the image and retains the public label as a text-verification entry." }, "source": { "id": "src_a59adb986c93b6ac", "label": "DailyMed（NLM）：COUMADIN 再包装历史标签说明", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=91fa852c-b43d-4a55-983b-74aa6827125d", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "COUMADIN 说明书放大阅读：mg、INR 与完整药单要一起看", "en": "COUMADIN label reading: mg, INR and the full medicine list belong together" }, "summary": { "zh": "本模块只解释 FDA 2015 美国标签档案中的产品识别和风险阅读线索。它不推算华法林剂量、INR 目标、漏服处理、饮食调整或转换方案。", "en": "This module explains product-identity and risk-reading clues in the 2015 U.S. FDA label archive only. It does not calculate warfarin dosage, INR targets, missed-dose handling, diet changes or conversion plans." }, "checks": [ { "zh": "该美国标签列出 1、2、2.5、3、4、5、6、7.5、10 mg 等不同刻痕片剂强度，以及注射用制剂。mg 是具体产品单位的身份线索，不是个人每天应服几片的答案，也不能只按颜色、刻痕或数字自行调节。", "en": "This U.S. label lists scored tablet strengths including 1, 2, 2.5, 3, 4, 5, 6, 7.5 and 10 mg, as well as an injectable presentation. mg identifies a specific product unit; it is not an answer to a person's daily tablet count and cannot be self-adjusted from colour, score marks or a number alone." }, { "zh": "标签将 INR 监测作为治疗中的重要信息，并说明药物、饮食改变和其他因素会影响 INR。任何新的处方药、非处方药、草本/保健品、抗菌药或饮食显著变化，都应按负责团队的既定流程复核，不要因网页或他人经验自行改量。", "en": "The label identifies INR monitoring as important and notes that medicines, dietary changes and other factors can affect INR. Any new prescription, OTC product, herb/supplement, antibiotic or major diet change should be reviewed through the responsible team's established process, not self-adjusted from a webpage or someone else's experience." }, { "zh": "标签提到基因型信息可为初始剂量选择提供信息，但这不表示每个人都应自行做“全基因筛查”，更不表示可据报告自行开始、停止或改变抗凝药。基因结果如已存在，应与完整病史、监测记录和全部用药由专业人员解释。", "en": "The label says genotype information can inform initial dose selection, but that does not mean everyone should independently obtain broad genetic screening or use a report to start, stop or change an anticoagulant. If a result already exists, a professional should interpret it with the full history, monitoring record and medicine list." }, { "zh": "异常出血、黑便、呕血、跌倒或头部受伤、计划手术/牙科操作等情况不适合只依靠网页处理；应尽快联系当地负责团队或紧急医疗服务。", "en": "Unexpected bleeding, black stools, vomiting blood, a fall or head injury, or a planned surgical/dental procedure are not situations to manage from a webpage alone; contact the responsible local team or emergency medical services promptly." } ], "source": { "id": "src_acac1255f20ea439", "label": "FDA：COUMADIN 2015 美国标签（NDA 009218）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/009218s115lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "华法林怎样起作用：它影响维生素 K 依赖性凝血因子的合成", "en": "How warfarin works: it affects synthesis of vitamin K-dependent clotting factors" }, "summary": { "zh": "FDA 公开标签说明华法林会影响维生素 K 依赖性凝血因子 II、VII、IX、X，以及抗凝蛋白 C 和 S 的合成；标签认为其与抑制 VKORC1 酶复合体有关。这解释了为什么监测、药物清单和饮食变化需要一起讨论，但不推导个人剂量、INR 目标、饮食调整或转换方案。", "en": "The FDA public label explains that warfarin affects synthesis of vitamin K-dependent clotting factors II, VII, IX and X, as well as anticoagulant proteins C and S; it describes interference with the VKORC1 enzyme complex. This helps explain why monitoring, the medicine list and dietary changes need to be discussed together, but it does not derive an individual's dose, INR target, diet adjustment or conversion plan." }, "checks": [ { "zh": "这条机制不代表“少吃或多吃某种食物”即可自行校正。任何明显饮食变化、抗菌药、草本/保健品、非处方药或新的处方药，都应按负责团队的既定 INR 监测流程复核。", "en": "This mechanism does not mean that eating less or more of one food can be used for self-correction. Any meaningful dietary change, antibiotic, herb/supplement, OTC product or new prescription needs review through the responsible team's established INR-monitoring process." }, { "zh": "“影响维生素 K 通路”不是广泛基因筛查或自行按基因报告改量的理由。标签中的基因组信息只应由专业人员与病史、监测结果和完整药单共同解释。", "en": "“Affecting the vitamin K pathway” is not a reason for broad genetic screening or self-adjustment from a genetic report. Genomic information in the label should be interpreted by a professional together with history, monitoring results and the complete medicine list." }, { "zh": "机制不能决定是否与其他抗凝/抗血小板药同用、漏服后如何处理或何时停药。异常出血、黑便、呕血、跌倒或头部受伤，应联系当地负责团队或紧急医疗服务。", "en": "Mechanism cannot decide whether to use another anticoagulant or antiplatelet medicine together, how to handle missed use or when to interrupt treatment. For unexpected bleeding, black stools, vomiting blood, a fall or head injury, contact the responsible local team or emergency medical services." } ], "source": { "id": "src_acac1255f20ea439", "label": "FDA：COUMADIN 2015 美国标签（临床药理）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/009218s115lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "Coumadin", "generic": "华法林钠", "dosageFormClass": "多种剂型（口服片剂及静脉注射用制剂；FDA 2015 历史标签所列；本页精确展示 9 个口服片 100 片瓶装身份及 1 个注射用 6 瓶纸盒身份）" }, "labelSource": { "id": "src_acac1255f20ea439", "label": "FDA：COUMADIN 2015 美国标签（NDA 009218）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/009218s115lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "productRoutes": [ { "source": { "id": "src_acac1255f20ea439", "label": "FDA：COUMADIN 2015 美国标签（NDA 009218）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/009218s115lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [ { "id": "fda-pharmacogenomic-label-record-warfarin", "issuedAt": "2025-12", "status": "fda_pharmacogenomic_label_record", "title": { "zh": "FDA 药物基因组标签记录：warfarin 与 CYP2C9 / VKORC1", "en": "FDA pharmacogenomic label record: warfarin and CYP2C9 / VKORC1" }, "summary": { "zh": "FDA 的药物基因组标签表将 warfarin（Coumadin）列入与 CYP2C9 / VKORC1 相关的标签信息项目。该表是美国监管机构对标签中基因组信息位置的索引，不等于每位使用者都需要筛查、已检测者就应自行改剂量，或可自行换成另一种药。是否检测、怎样解释结果及与其他药同用的问题，必须连同准确产品、适应症、现行标签和完整用药清单由开方团队或药师核对。", "en": "FDA’s Table of Pharmacogenomic Biomarkers in Drug Labeling lists warfarin (Coumadin) with CYP2C9 / VKORC1-related labeling information. The table is a U.S. regulator index to where genomic information appears in labeling; it does not mean every user needs screening, that a tested person should self-change a dose, or that another medicine may be substituted independently. Whether to test, how to interpret a result and how it relates to other medicines must be reviewed with the exact product, indication, current label and complete medicine list by the prescribing team or pharmacist." }, "source": { "id": "src_9f4d37bf0406cd2b", "label": "FDA：药品标签中的药物基因组生物标志物表", "url": "https://www.fda.gov/drugs/science-and-research-drugs/table-pharmacogenomic-biomarkers-drug-labeling/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "pharmacogenomic_label_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "FDA 的 COUMADIN（warfarin sodium）2015 美国标签档案列有口服片剂和静脉用制剂，并列出美国初始批准年份为 1954。为防止把颜色、刻痕、mg、每瓶标示量或注射剂混在一起，本页分别建立该历史标签中 1、2、2.5、3、4、5、6、7.5、10 mg 九种口服单刻痕片的 100 片瓶装身份，以及 5 mg、6 瓶纸盒的独立静脉注射用制剂身份；它们不提供个人片数、个人注射量、INR 调整、漏服、饮食改变、转换或停药方案。该标签包含出血风险的加框警告和 INR 监测信息；本页只帮助读者回到一手文件，不能据此生成个人抗凝方案。", "history": "FDA 的 2015 文件明确提示其可能不是最新获批标签。其口服片为单刻痕：一面带 COUMADIN 与数字、另一面空白；该外观事实只帮助阅读历史标签，刻痕本身不等于可以自行掰开、减量或改变产品。抗凝药的产品身份、监测安排、相互作用和围手术期处理都不能只按药名或照片判断。任何转换、漏服、停用或联用问题须回到所在市场的当前标签与负责团队。", "sourceDocuments": [ { "id": "src_acac1255f20ea439", "label": "FDA：COUMADIN 2015 美国标签（NDA 009218）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/009218s115lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_5ed30b676fbb9773", "label": "FDA Drugs@FDA 官方检索入口", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_lookup_entry", "documentKind": "regulatory_lookup", "market": "US", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } ], "applicationNumber": "NDA 009218", "approvalTimeline": [ { "date": "1954", "title": { "zh": "FDA 标签所列美国初始批准年份", "en": "Initial U.S. approval year listed in the FDA label" }, "detail": { "zh": "本页链接的 FDA 标签档案列示 Initial U.S. Approval: 1954。该历史定位不等同于当前批准、可得性、持有人或其他市场状态。", "en": "The FDA label archive linked here lists Initial U.S. Approval: 1954. This historical locator is not a conclusion about current approval, availability, holder or another market." }, "source": { "id": "src_acac1255f20ea439", "label": "FDA: COUMADIN label archive", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/009218s115lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, { "date": "2015-10", "title": { "zh": "FDA 标签档案版本", "en": "FDA label archive version" }, "detail": { "zh": "本页链接 2015-10 的 FDA 标签档案作为可复核阅读入口。现行标签、规格、适应症和安全信息必须另行以目标市场当前文件核对。", "en": "This page links the 2015-10 FDA label archive as a traceable reading entry point. Current labeling, strength, indication and safety information require separate verification against the target market’s current document." }, "source": { "id": "src_acac1255f20ea439", "label": "FDA: COUMADIN label archive", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/009218s115lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "已链接公开标签档案", "en": "Public label archive linked" }, "detail": { "zh": "仅对应本页所列 FDA 文件。", "en": "Only the FDA document listed on this page is linked." } }, { "market": { "zh": "中国大陆、欧盟、日本", "en": "Mainland China, EU, Japan" }, "status": { "zh": "待逐项建立市场记录", "en": "Market record not established" }, "detail": { "zh": "不从美国标签档案推定当地批准、持有人、规格、供应或可售资格。", "en": "No local approval, holder, strength, supply or sale-eligibility conclusion is inferred from the U.S. label archive." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "标签档案能代表现在的产品信息吗？", "en": "Does a label archive represent current product information?" }, "answer": { "zh": "不能自动代表。档案用于定位来源；需要以目标市场的现行官方标签逐项复核。", "en": "Not automatically. The archive locates a source; each point needs verification against the target market’s current official label." } }, { "question": { "zh": "为什么这里不展示价格或原研/仿制结论？", "en": "Why are price and originator/generic conclusions not shown?" }, "answer": { "zh": "这些结论需要产品、剂型、规格、包装、市场、日期和原始记录分别齐全并经人工审核；单一标签文件不足以支持。", "en": "Those conclusions require separately complete and human-reviewed product, dosage-form, strength, pack, market, date and primary-record fields; one label file is insufficient." } } ], "relatedMedicineChecks": [ { "target": { "id": "tylenol-extra-strength", "brand": "Tylenol Extra Strength", "generic": "对乙酰氨基酚", "canonicalUrls": { "zh": "https://origindrug.com/drugs/tylenol-extra-strength/", "en": "https://origindrug.com/en/drugs/tylenol-extra-strength/" } }, "title": { "zh": "与 TYLENOL Extra Strength 同在药单上时：止痛退热药也要先核对", "en": "When TYLENOL Extra Strength is on the same list: an analgesic or fever medicine also needs review first" }, "summary": { "zh": "TYLENOL Extra Strength 的美国公开 Drug Facts 提示，正在使用华法林时应先咨询医生或药师。本卡片只提示把实际 TYLENOL 包装、华法林包装、其他止痛/感冒药、处方药、非处方药和补充剂交给负责团队核对；它不判断能否同服，也不建议自行停用、错开时间、替换或调整任何一种药。", "en": "The U.S. public Drug Facts for TYLENOL Extra Strength says to ask a doctor or pharmacist before use when taking warfarin. This card only signals that the actual TYLENOL pack, warfarin pack, other pain/cold products, prescription medicines, OTC products and supplements need review by the responsible team; it does not decide co-use or advise self-stopping, time-separation, replacement or adjustment of either medicine." }, "source": { "id": "src_5996c8561aae7112", "label": "DailyMed（NLM）：TYLENOL Extra Strength 当前美国公开标签（Kenvue；SPL v16）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=103d109d-f520-409c-8da2-eb6b0fbec891&version=16", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "review_complete_medicine_list_no_self_directed_change" }, { "target": { "id": "advil-tablets", "brand": "Advil", "generic": "布洛芬", "canonicalUrls": { "zh": "https://origindrug.com/drugs/advil-tablets/", "en": "https://origindrug.com/en/drugs/advil-tablets/" } }, "title": { "zh": "与 ADVIL／布洛芬同在药单上时：抗凝药提示应先核对完整药单", "en": "When ADVIL / ibuprofen is on the same list: an anticoagulant calls for a complete medicine-list review first" }, "summary": { "zh": "ADVIL 当前美国公开 Drug Facts 将正在使用抗凝药列为胃出血警示中需要留意的风险线索。本卡片只提示把实际 Advil 包装、华法林包装、其他止痛/感冒药、处方药、非处方药和补充剂交给负责团队核对；它不判断能否同服，也不建议自行停用、错开时间、替换或调整任何一种药。", "en": "The current U.S. public Drug Facts for ADVIL lists use of a blood-thinning anticoagulant as a risk cue in its stomach-bleeding warning. This card only signals that the actual Advil pack, warfarin pack, other pain/cold products, prescription medicines, OTC products and supplements need review by the responsible team; it does not decide co-use or advise self-stopping, time-separation, replacement or adjustment of either medicine." }, "source": { "id": "src_a0ff83312e9e0cbd", "label": "DailyMed（NLM）：ADVIL 布洛芬当前美国公开标签（Haleon；SPL v38）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=1a665e64-9f30-be37-4a83-38789f1f1e89", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "review_complete_medicine_list_no_self_directed_change" }, { "target": { "id": "trulicity", "brand": "Trulicity", "generic": "度拉糖肽", "canonicalUrls": { "zh": "https://origindrug.com/drugs/trulicity/", "en": "https://origindrug.com/en/drugs/trulicity/" } }, "title": { "zh": "与 TRULICITY／度拉糖肽同在药单上时：治疗窗较窄的口服药先做完整核对", "en": "When TRULICITY / dulaglutide is on the same list: review a narrow-therapeutic-index oral medicine first" }, "summary": { "zh": "FDA 的 2025 TRULICITY 标签说明其可延缓胃排空，可能降低同用口服药的吸收速率；并明确将华法林列为治疗窗较窄、需要由专业人员监测药物水平的口服药示例。这张卡只提示把华法林、TRULICITY、所有实际药盒、非处方药和补充剂交给药师或开方团队核对；它不提供个人监测目标、给药间隔或调整方案，也不建议自行停用、错开时间、替换或调整任何一种药。", "en": "The FDA's 2025 TRULICITY label says it delays gastric emptying and may reduce the rate of absorption of concomitant oral medicines; it names warfarin as an example of an oral medicine with a narrow therapeutic index for which professionals monitor drug levels. This card only signals that warfarin, TRULICITY, every actual pack, OTC product and supplement should be reviewed by a pharmacist or prescriber; it provides no individual monitoring target, timing interval or adjustment plan and does not decide co-use or advise self-stopping, time-separation, replacement or adjustment of either medicine." }, "source": { "id": "src_198d9ae73f3553a3", "label": "FDA：TRULICITY 2025 美国处方信息（7.1 Oral Medications：华法林为治疗窗较窄口服药示例）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/125469s063lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "review_complete_medicine_list_no_self_directed_change" }, { "target": { "id": "bayer-low-dose-aspirin", "brand": "BAYER LOW DOSE ASPIRIN", "generic": "阿司匹林", "canonicalUrls": { "zh": "https://origindrug.com/drugs/bayer-low-dose-aspirin/", "en": "https://origindrug.com/en/drugs/bayer-low-dose-aspirin/" } }, "title": { "zh": "与 BAYER LOW DOSE ASPIRIN／阿司匹林 81 mg 同在药单上时：先核对完整药单", "en": "When BAYER LOW DOSE ASPIRIN / aspirin 81 mg is on the same list: review the complete medicine list first" }, "summary": { "zh": "BAYER LOW DOSE ASPIRIN 的当前美国公开 Drug Facts 将正在使用抗凝药列为胃出血警示中需要先核对的线索。本卡片只提示把实际阿司匹林包装、华法林包装、其他止痛/感冒药、处方药、非处方药、草本和补充剂交给药师或医生核对；它不判断任何人能否同服，也不建议自行停用、错开时间、替换或调整任何一种药。开始使用或其他变动同样需要先由药师或医生核对。", "en": "The current U.S. public Drug Facts for BAYER LOW DOSE ASPIRIN lists use of an anticoagulant as a cue that needs review in its stomach-bleeding warning. This card only signals that the actual aspirin pack, warfarin pack, other pain/cold products, prescriptions, OTC products, herbs and supplements need review by a pharmacist or clinician; it does not decide whether anyone can use them together or advise self-stopping, time-separation, replacement or adjustment of either medicine. Starting a medicine or making another change also needs pharmacist or clinician review." }, "source": { "id": "src_3c1cad1341a17717", "label": "DailyMed（NLM）：BAYER LOW DOSE ASPIRIN 当前美国公开标签（Bayer HealthCare；SPL v8，抗凝药警示）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=075b103e-0bb4-4b7a-ac0e-5645bcbd0a07&version=8", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "review_complete_medicine_list_no_self_directed_change" }, { "target": { "id": "amiodarone-cordarone", "brand": "CORDARONE", "generic": "胺碘酮", "canonicalUrls": { "zh": "https://origindrug.com/drugs/amiodarone-cordarone/", "en": "https://origindrug.com/en/drugs/amiodarone-cordarone/" } }, "title": { "zh": "与 CORDARONE／胺碘酮同在药单上时：这是需要专业监测的高风险核对项", "en": "When CORDARONE / amiodarone is on the same list: this is a high-risk professional-monitoring check" }, "summary": { "zh": "当前美国华法林通用名标签将胺碘酮列入需要核对的相互作用药物；当前胺碘酮通用名标签还提示其停用后相互作用仍可能持续数周至数月。本卡片只提示尽快把两种实际药盒、当前说明书、监测记录和完整药单交给开方团队、药师或抗凝管理团队核对；它不判断能否同用，不提供 INR 目标、剂量、给药间隔或停换药方案，也不建议自行停用、错开时间、替换或调整任何一种药。COUMADIN 与 CORDARONE 页面均含历史品牌档案，当前通用名标签不证明这些品牌当前供应或市场状态。", "en": "A current U.S. generic warfarin label lists amiodarone among medicines requiring interaction review, while a current generic amiodarone label also notes that interactions can persist for weeks to months after amiodarone is stopped. This card only signals that both actual packs, current labels, monitoring records and the complete medicine list need prompt review by the prescribing team, pharmacist or anticoagulation service; it does not decide co-use, provide an INR target, dose, timing interval or stop/switch plan, or advise self-stopping, time-separation, replacement or adjustment of either medicine. The COUMADIN and CORDARONE pages include historical brand archives; current generic labels do not establish current brand supply or market status." }, "source": { "id": "src_3490da81ff5c9135", "label": "DailyMed（NLM）：华法林当前美国通用名标签（列示胺碘酮；仅作成分层核对，不代表 COUMADIN 当前市场状态）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a4cf3107-5646-4b91-8aae-94548e4409ef", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-05", "reviewedAt": "2026-09-05" }, "scope": "review_complete_medicine_list_no_self_directed_change" }, { "target": { "id": "levaquin", "brand": "Levaquin", "generic": "左氧氟沙星", "canonicalUrls": { "zh": "https://origindrug.com/drugs/levaquin/", "en": "https://origindrug.com/en/drugs/levaquin/" } }, "title": { "zh": "与 CRAVIT／可乐必妥／LEVAQUIN 同在药单上时：先核对 INR 与出血监测记录", "en": "When CRAVIT / LEVAQUIN is on the same list: review INR and bleeding-monitoring records first" }, "summary": { "zh": "FDA 的 2019 年 LEVAQUIN 美国历史口服片标签将华法林列为需要核对的药物，并提示上市后报告中出现华法林作用增强、凝血酶原时间或 INR 升高及出血事件。该文件同时明确可能不是 FDA 最新批准标签，因此这张卡只作有日期、美国、成分层面的优先核对提示：请把两种实际药盒、目标市场现行说明书、最近的监测记录以及所有处方药、非处方药和补充剂尽快交给开方团队、药师或抗凝管理团队复核。它不判断个人能否同用，不提供 INR 目标、片数、给药间隔或停换药方案，也不建议自行停用、错开时间、替换或调整任何一种药。", "en": "The FDA's 2019 historical U.S. oral-tablet label for LEVAQUIN lists warfarin as a medicine requiring review and describes postmarketing reports of enhanced warfarin effect, increased prothrombin time or INR, and bleeding episodes. The document also states that it may not be FDA's latest approved label. This card is therefore only a dated, U.S., ingredient-level priority-review cue: promptly take both actual packs, current target-market labels, recent monitoring records, and every prescription, OTC product and supplement to the prescribing team, pharmacist or anticoagulation service. It does not decide individual co-use, provide an INR target, tablet count, timing interval or stop/switch plan, or advise self-stopping, time-separation, replacement or adjustment of either medicine." }, "source": { "id": "src_4e39fcca7a55ea86", "label": "FDA：LEVAQUIN 2019 美国历史口服片标签（7.2 Warfarin；文件明确可能不是最新批准标签）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020634s072lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-09-13", "reviewedAt": "2026-09-13" }, "scope": "review_complete_medicine_list_no_self_directed_change" } ], "relatedArticleSlugs": [ "dosage-forms-are-part-of-medicine-identity", "medicine-label-for-everyday-questions", "how-to-read-a-drug-label" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/coumadin/", "en": "https://origindrug.com/en/drugs/coumadin/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "pradaxa", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-21", "status": "published_traceable_archive" }, "names": { "brand": "Pradaxa", "generic": "达比加群酯", "aliases": [ "达比加群酯", "dabigatran etexilate", "dabigatran" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "抗凝与血液", "sourceArchiveMarket": "美国公开监管标签档案", "dosageFormClass": "口服胶囊：75 mg、110 mg、150 mg（FDA 2025 标签所列；口服颗粒不并入本胶囊档案）", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "2010（FDA 2025 标签所列美国初始批准）", "archiveSponsorText": "Boehringer Ingelheim / FDA 与 DailyMed 公开标签档案" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [ "PRADAXA oral pellets", "PRADAXA pellets", "dabigatran etexilate pellets", "达比加群酯口服颗粒" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-pradaxa-capsule-75mg-0597-0355-09", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v48（2025-06-25 更新；2025-06-30 发布）", "en": "DailyMed SPL v48 (updated 25 Jun 2025; published 30 Jun 2025)" }, "dosageForm": { "zh": "达比加群酯口服胶囊", "en": "dabigatran etexilate oral capsule" }, "route": { "zh": "口服（仅作标签产品身份字段）", "en": "oral (label product-identity field only)" }, "routeCodes": [ "oral" ], "productCode": "NDC 0597-0355-09", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_capsule", "primaryDisplay": { "zh": "每粒 75 mg；60 粒瓶装", "en": "75 mg per capsule; 60-capsule bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=pradaxa-10.jpg&setid=ba74e3cd-b06f-4145-b284-5fd6b84ff3c9&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "达比加群酯", "en": "dabigatran etexilate" }, "value": 75, "unit": "mg", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒胶囊标签标示量；不是个人服用数量或换算指令", "en": "labelled amount per capsule; not an individual capsule count or conversion instruction" } } ], "concentration": null, "container": { "typeCode": "unit_of_use_bottle", "typeLabel": { "zh": "原瓶（使用单位瓶装）", "en": "unit-of-use bottle" }, "fill": null, "countPerPackage": 60, "countUnit": { "zh": "粒胶囊/瓶", "en": "capsules per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-21", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 60, "unit": { "zh": "粒胶囊/瓶", "en": "capsules per bottle" } }, "physicalClues": { "color": { "zh": "白色不透明帽与白色不透明体", "en": "white opaque cap and white opaque body" }, "shape": { "zh": "硬胶囊", "en": "hard capsule" }, "imprint": "R75", "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_d0153f52d86268c6", "label": "DailyMed（NLM）：PRADAXA 达比加群酯当前美国公开标签（Boehringer Ingelheim；SPL v48）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ba74e3cd-b06f-4145-b284-5fd6b84ff3c9", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-pradaxa-capsule-110mg-0597-0108-54", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v48（2025-06-25 更新；2025-06-30 发布）", "en": "DailyMed SPL v48 (updated 25 Jun 2025; published 30 Jun 2025)" }, "dosageForm": { "zh": "达比加群酯口服胶囊", "en": "dabigatran etexilate oral capsule" }, "route": { "zh": "口服（仅作标签产品身份字段）", "en": "oral (label product-identity field only)" }, "routeCodes": [ "oral" ], "productCode": "NDC 0597-0108-54", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_capsule", "primaryDisplay": { "zh": "每粒 110 mg；60 粒瓶装", "en": "110 mg per capsule; 60-capsule bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=pradaxa-09.jpg&setid=ba74e3cd-b06f-4145-b284-5fd6b84ff3c9&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "达比加群酯", "en": "dabigatran etexilate" }, "value": 110, "unit": "mg", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒胶囊标签标示量；不是个人服用数量或换算指令", "en": "labelled amount per capsule; not an individual capsule count or conversion instruction" } } ], "concentration": null, "container": { "typeCode": "unit_of_use_bottle", "typeLabel": { "zh": "原瓶（使用单位瓶装）", "en": "unit-of-use bottle" }, "fill": null, "countPerPackage": 60, "countUnit": { "zh": "粒胶囊/瓶", "en": "capsules per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-21", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 60, "unit": { "zh": "粒胶囊/瓶", "en": "capsules per bottle" } }, "physicalClues": { "color": { "zh": "浅蓝色不透明帽与浅蓝色不透明体", "en": "light-blue opaque cap and light-blue opaque body" }, "shape": { "zh": "硬胶囊", "en": "hard capsule" }, "imprint": "R110", "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_d0153f52d86268c6", "label": "DailyMed（NLM）：PRADAXA 达比加群酯当前美国公开标签（Boehringer Ingelheim；SPL v48）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ba74e3cd-b06f-4145-b284-5fd6b84ff3c9", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-pradaxa-capsule-150mg-0597-0360-55", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v48（2025-06-25 更新；2025-06-30 发布）", "en": "DailyMed SPL v48 (updated 25 Jun 2025; published 30 Jun 2025)" }, "dosageForm": { "zh": "达比加群酯口服胶囊", "en": "dabigatran etexilate oral capsule" }, "route": { "zh": "口服（仅作标签产品身份字段）", "en": "oral (label product-identity field only)" }, "routeCodes": [ "oral" ], "productCode": "NDC 0597-0360-55", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_capsule", "primaryDisplay": { "zh": "每粒 150 mg；60 粒瓶装", "en": "150 mg per capsule; 60-capsule bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=pradaxa-11.jpg&setid=ba74e3cd-b06f-4145-b284-5fd6b84ff3c9&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "达比加群酯", "en": "dabigatran etexilate" }, "value": 150, "unit": "mg", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒胶囊标签标示量；不是个人服用数量或换算指令", "en": "labelled amount per capsule; not an individual capsule count or conversion instruction" } } ], "concentration": null, "container": { "typeCode": "unit_of_use_bottle", "typeLabel": { "zh": "原瓶（使用单位瓶装）", "en": "unit-of-use bottle" }, "fill": null, "countPerPackage": 60, "countUnit": { "zh": "粒胶囊/瓶", "en": "capsules per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-21", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 60, "unit": { "zh": "粒胶囊/瓶", "en": "capsules per bottle" } }, "physicalClues": { "color": { "zh": "浅蓝色不透明帽与白色不透明体", "en": "light-blue opaque cap and white opaque body" }, "shape": { "zh": "硬胶囊", "en": "hard capsule" }, "imprint": "R150", "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_d0153f52d86268c6", "label": "DailyMed（NLM）：PRADAXA 达比加群酯当前美国公开标签（Boehringer Ingelheim；SPL v48）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ba74e3cd-b06f-4145-b284-5fd6b84ff3c9", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-pradaxa-capsule-110mg-0597-0108-54", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=pradaxa-09.jpg&setid=ba74e3cd-b06f-4145-b284-5fd6b84ff3c9&type=img", "alt": "PRADAXA 达比加群酯在美国 DailyMed 公开标签中的 110 mg、60 粒瓶装标签图", "archiveMarket": "美国", "labelVersion": "DailyMed SPL v48（2025-06-25 更新；2025-06-30 发布）", "presentation": "PRADAXA 达比加群酯 110 mg、60 粒胶囊瓶装标签图（DailyMed 公开标签所列）。", "notice": "此图只对应美国 DailyMed SPL v48 中 PRADAXA 110 mg、NDC 0597-0108-54、60 粒原瓶标签图，只帮助核对品牌、通用名、标示强度、胶囊剂型、包装数量与来源；不用于鉴定真伪，也不证明 75 mg、150 mg、泡罩、口服颗粒、其他市场标签、原研身份、目标市场批准或可售资格。", "source": { "id": "src_d0153f52d86268c6", "label": "DailyMed（NLM）：PRADAXA 达比加群酯当前美国公开标签（Boehringer Ingelheim；SPL v48）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ba74e3cd-b06f-4145-b284-5fd6b84ff3c9", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "PRADAXA / 达比加群酯说明书放大阅读：胶囊、原瓶防潮与不能自行换算", "en": "PRADAXA label reading: capsules, original-container storage and no self-conversion" }, "summary": { "zh": "本模块以 FDA 与 DailyMed 的 2025 美国公开标签为阅读入口，帮助识别 PRADAXA、达比加群酯、胶囊、标示强度和储存提示。它不生成个人服用数量、补服、停用、联用、换药或操作前后安排。", "en": "This module uses 2025 U.S. FDA and DailyMed public labels as a reading entry point for PRADAXA, dabigatran etexilate, capsules, stated strength and storage wording. It does not generate an individual capsule count, missed-dose, stopping, combination, switching or procedure plan." }, "checks": [ { "zh": "先同时核对 PRADAXA、达比加群酯、胶囊、每粒标示强度和目标市场。75、110、150 mg 是标签所列单粒强度线索，不是个人应服用几粒或如何换算的答案。", "en": "First check PRADAXA, dabigatran etexilate, capsule form, stated strength per capsule and target market together. 75, 110 and 150 mg are labelled per-capsule strength clues, not an answer to how many capsules an individual should take or convert." }, { "zh": "FDA 公开标签写明胶囊应整粒吞服；不要咀嚼、掰开或打开胶囊颗粒。该标签还提示，PRADAXA 胶囊不能与其他达比加群酯剂型按 mg 对 mg 自行互换。", "en": "The FDA public label says capsules should be swallowed whole; do not chew, break or open the capsule pellets. It also states that PRADAXA capsules are not to be self-substituted milligram-for-milligram with other dabigatran etexilate dosage forms." }, { "zh": "该美国标签提示将胶囊保留在原瓶或原泡罩中以防潮；不要为方便而转入分药盒。若使用原瓶，标签还列出开瓶后的使用期限；此为美国标签阅读提示，实际产品和当地说明书必须由药师核对。", "en": "The U.S. label says to keep capsules in the original bottle or blister packaging to protect from moisture; do not move them into a pill organizer merely for convenience. It also lists an in-use period after opening a bottle; this is a U.S.-label reading point, and the actual product and local leaflet require pharmacist review." }, { "zh": "抗凝药不能因为漏服担心、出血担心、检查/手术、拿到不同包装或他人建议而自行停用、加量、补双份、叠加或换成其他抗凝/抗血小板药。出现严重或难以控制的出血、昏厥、呼吸困难、突发神经系统症状等紧急情况，应立即使用当地紧急医疗服务。", "en": "An anticoagulant must not be self-stopped, increased, doubled, combined or switched to another anticoagulant or antiplatelet medicine because of a missed-dose concern, bleeding concern, a procedure, a different pack or someone else’s advice. With severe or uncontrolled bleeding, fainting, breathing difficulty or sudden neurological symptoms, seek local emergency care immediately." } ], "source": { "id": "src_dc1a1cae5d73a14a", "label": "FDA：PRADAXA 2025 美国处方信息（NDA 022512）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/022512s049lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "达比加群酯怎样起作用：它是直接凝血酶抑制剂", "en": "How dabigatran etexilate works: it is a direct thrombin inhibitor" }, "summary": { "zh": "FDA 2025 公开标签将达比加群列为直接凝血酶抑制剂。这个机制只解释作用路径，不判断个人是否需要抗凝，也不决定个人胶囊数量、联用、换用、停用或检查/手术安排。", "en": "The 2025 FDA public label describes dabigatran as a direct thrombin inhibitor. This explains a pathway only; it does not determine whether an individual needs anticoagulation or decide an individual capsule count, combination, switching, stopping or procedure plan." }, "checks": [ { "zh": "“直接凝血酶抑制剂”不是自行判断血栓风险、出血风险或治疗是否合适的工具；诊断、肾功能、年龄、其他疾病、完整药单和现行标签都可能影响专业判断。", "en": "“Direct thrombin inhibitor” is not a tool for self-judging clot risk, bleeding risk or whether treatment is appropriate; diagnosis, kidney function, age, other conditions, the full medicine list and current label can all affect professional assessment." }, { "zh": "相同的“抗凝”目的或类似机制，不使 PRADAXA 与华法林、阿哌沙班、利伐沙班或抗血小板药可自行叠加、轮换、替换或按 mg 换算。任何改变必须由开方医生或药师用实际产品和完整药单核对。", "en": "A shared anticoagulation purpose or related mechanism does not make PRADAXA self-combinable, interchangeable or milligram-convertible with warfarin, apixaban, rivaroxaban or an antiplatelet medicine. Any change requires the prescriber or pharmacist to review the actual products and full medicine list." }, { "zh": "机制页面也不能决定是否暂停、何时恢复、漏服后怎样处理或围手术期怎样安排。对上述问题或出现出血、不适、跌倒/外伤后担忧时，请及时联系当地医疗团队；紧急情况使用当地急救服务。", "en": "A mechanism page also cannot decide whether to pause, when to resume, how to handle a missed dose or how to plan around a procedure. For those questions, bleeding, feeling unwell or concern after a fall or injury, contact the local care team promptly; use emergency services for emergencies." } ], "source": { "id": "src_dc1a1cae5d73a14a", "label": "FDA：PRADAXA 2025 美国处方信息（临床药理）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/022512s049lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "Pradaxa", "generic": "达比加群酯", "dosageFormClass": "口服胶囊：75 mg、110 mg、150 mg（FDA 2025 标签所列；口服颗粒不并入本胶囊档案）" }, "labelSource": { "id": "src_dc1a1cae5d73a14a", "label": "FDA：PRADAXA 2025 美国处方信息（NDA 022512）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/022512s049lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "productRoutes": [ { "source": { "id": "src_dc1a1cae5d73a14a", "label": "FDA：PRADAXA 2025 美国处方信息（NDA 022512）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/022512s049lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_d0153f52d86268c6", "label": "DailyMed（NLM）：PRADAXA 公开标签（Boehringer Ingelheim，2025-06 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ba74e3cd-b06f-4145-b284-5fd6b84ff3c9", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "FDA 与 DailyMed 的 PRADAXA（dabigatran etexilate）2025 美国公开标签将其列为口服胶囊，并列示 75 mg、110 mg、150 mg 与美国初始批准年份 2010。本页仅建立这一美国公开标签的阅读入口；不据此推定任何市场的当前批准、持有人、规格、适应症、供应、原研关系或可售资格。", "history": "抗凝药包装上的 mg、胶囊数量和品牌名都只是产品身份线索，不能变成自行开始、停用、补服、叠加、换药或围手术期安排的指令。尤其在同时使用多种药物时，应让医生或药师以实际包装、完整药单和目标市场的现行文件逐项核对。", "sourceDocuments": [ { "id": "src_dc1a1cae5d73a14a", "label": "FDA：PRADAXA 2025 美国处方信息（NDA 022512）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/022512s049lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_d0153f52d86268c6", "label": "DailyMed（NLM）：PRADAXA 公开标签（Boehringer Ingelheim，2025-06 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ba74e3cd-b06f-4145-b284-5fd6b84ff3c9", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } ], "applicationNumber": "NDA 022512", "approvalTimeline": [ { "date": "2010", "title": { "zh": "FDA 标签所列美国初始批准年份", "en": "Initial U.S. approval year listed in the FDA label" }, "detail": { "zh": "本页链接的 FDA 标签档案列示 Initial U.S. Approval: 2010。该历史定位不等同于当前批准、可得性、持有人或其他市场状态。", "en": "The FDA label archive linked here lists Initial U.S. Approval: 2010. This historical locator is not a conclusion about current approval, availability, holder or another market." }, "source": { "id": "src_dc1a1cae5d73a14a", "label": "FDA: PRADAXA label archive", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/022512s049lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, { "date": "2025-06", "title": { "zh": "FDA 标签档案版本", "en": "FDA label archive version" }, "detail": { "zh": "本页链接 2025-06 的 FDA 标签档案作为可复核阅读入口。现行标签、规格、适应症和安全信息必须另行以目标市场当前文件核对。", "en": "This page links the 2025-06 FDA label archive as a traceable reading entry point. Current labeling, strength, indication and safety information require separate verification against the target market’s current document." }, "source": { "id": "src_dc1a1cae5d73a14a", "label": "FDA: PRADAXA label archive", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/022512s049lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "已链接公开标签档案", "en": "Public label archive linked" }, "detail": { "zh": "仅对应本页所列 FDA 文件。", "en": "Only the FDA document listed on this page is linked." } }, { "market": { "zh": "中国大陆、欧盟、日本", "en": "Mainland China, EU, Japan" }, "status": { "zh": "待逐项建立市场记录", "en": "Market record not established" }, "detail": { "zh": "不从美国标签档案推定当地批准、持有人、规格、供应或可售资格。", "en": "No local approval, holder, strength, supply or sale-eligibility conclusion is inferred from the U.S. label archive." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "标签档案能代表现在的产品信息吗？", "en": "Does a label archive represent current product information?" }, "answer": { "zh": "不能自动代表。档案用于定位来源；需要以目标市场的现行官方标签逐项复核。", "en": "Not automatically. The archive locates a source; each point needs verification against the target market’s current official label." } }, { "question": { "zh": "为什么这里不展示价格或原研/仿制结论？", "en": "Why are price and originator/generic conclusions not shown?" }, "answer": { "zh": "这些结论需要产品、剂型、规格、包装、市场、日期和原始记录分别齐全并经人工审核；单一标签文件不足以支持。", "en": "Those conclusions require separately complete and human-reviewed product, dosage-form, strength, pack, market, date and primary-record fields; one label file is insufficient." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "how-to-read-a-drug-label", "regulatory-sources-first" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/pradaxa/", "en": "https://origindrug.com/en/drugs/pradaxa/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "lovenox", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-19", "status": "published_traceable_archive" }, "names": { "brand": "Lovenox", "generic": "依诺肝素钠", "aliases": [ "LOVENOX", "enoxaparin", "enoxaparin sodium", "依诺肝素", "依诺肝素钠" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "抗凝与血液", "sourceArchiveMarket": "美国当前 LOVENOX 依诺肝素钠注射液公开标签（处方信息 2025-05 修订；DailyMed SPL v33 于 2026-05-29 发布）", "dosageFormClass": "依诺肝素钠注射液：预充式单剂量注射器及多剂量瓶（当前美国标签所列）", "dosageFormClassCode": "subcutaneous_injection", "route": "皮下 / 静脉注射", "routeCode": "subcutaneous", "historicalApprovalEntry": "1993（当前美国标签所列 Initial U.S. Approval）", "archiveSponsorText": "Sanofi-Aventis U.S. LLC / DailyMed（NLM）当前公开标签档案" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-lovenox-40mg-0-4ml-ndc-0075-0620-40", "marketCode": "US", "labelVersion": { "zh": "处方信息 2025-05 修订；DailyMed SPL v33 于 2026-05-29 发布", "en": "Prescribing information revised May 2025; DailyMed SPL v33 published 29 May 2026" }, "dosageForm": { "zh": "依诺肝素钠注射液；单剂量预充式注射器", "en": "enoxaparin sodium injection; single-dose prefilled syringe" }, "route": { "zh": "皮下或静脉（标签范围；不由网页决定个人给药途径）", "en": "subcutaneous or intravenous (label scope; this page does not determine an individual's route)" }, "routeCodes": [ "subcutaneous", "intravenous" ], "productCode": "NDC 0075-0620-40", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "concentration", "primaryDisplay": { "zh": "40 mg/0.4 mL；100 mg/mL；10 支单剂量预充式注射器", "en": "40 mg/0.4 mL; 100 mg/mL; 10 single-dose prefilled syringes" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=5017a927-2a24-4f27-89f9-27c805bf7d59&name=5017a927-2a24-4f27-89f9-27c805bf7d59-26.jpg", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "依诺肝素钠", "en": "enoxaparin sodium" }, "value": 100, "unit": "mg/mL", "basisCode": "concentration", "basisLabel": { "zh": "标签浓度；不是个人注射量", "en": "labelled concentration; not an individual injection amount" } }, { "ingredient": { "zh": "依诺肝素钠", "en": "enoxaparin sodium" }, "value": 40, "unit": "mg", "basisCode": "per_single_dose_syringe", "basisLabel": { "zh": "每支单剂量预充式注射器标示量；不是个人给药指令", "en": "labelled amount in each single-dose prefilled syringe; not an individual administration instruction" } } ], "concentration": { "basisCode": "mass_per_volume", "notation": "100 mg/mL", "numerator": { "value": 100, "unit": "mg" }, "denominator": { "value": 1, "unit": "mL" }, "display": { "zh": "100 mg/mL（标签浓度；不是个人注射量）", "en": "100 mg/mL (labelled concentration; not an individual injection amount)" } }, "container": { "typeCode": "single_dose_prefilled_syringe", "typeLabel": { "zh": "单剂量预充式注射器（带自动安全装置）", "en": "single-dose prefilled syringe with automatic safety device" }, "fill": { "value": 0.4, "unit": "mL" }, "countPerPackage": 10, "countUnit": { "zh": "支单剂量预充式注射器/盒", "en": "single-dose prefilled syringes per carton" } }, "deliveryDevice": { "typeCode": "automatic_safety_device", "name": { "zh": "自动安全装置", "en": "automatic safety device" } }, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-20", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 10, "unit": { "zh": "支单剂量预充式注射器/盒", "en": "single-dose prefilled syringes per carton" } }, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_5fa0f35fe94cdc3b", "label": "DailyMed（NLM）：LOVENOX 依诺肝素钠当前美国公开标签（Sanofi-Aventis U.S. LLC；SPL v33）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=5017a927-2a24-4f27-89f9-27c805bf7d59", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-lovenox-40mg-0-4ml-ndc-0075-0620-40", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=5017a927-2a24-4f27-89f9-27c805bf7d59&name=5017a927-2a24-4f27-89f9-27c805bf7d59-26.jpg", "alt": "LOVENOX 依诺肝素钠当前美国 DailyMed 标签中的 40 mg/0.4 mL、NDC 0075-0620-40、十支单剂量预充式注射器纸盒展示面", "archiveMarket": "美国", "labelVersion": "DailyMed SPL v33（处方信息 2025-05 修订；2026-05-29 发布）", "presentation": "LOVENOX 依诺肝素钠注射液；40 mg/0.4 mL；NDC 0075-0620-40；十支单剂量预充式注射器（带自动安全装置）", "notice": "此图只对应美国当前标签中的 40 mg/0.4 mL 单剂量预充式注射器十支装。它不代表 30、60、80、100、120、150 mg 预充式注射器、300 mg/3 mL 多剂量瓶、其他依诺肝素产品或其他市场；不用于鉴定真伪，也不用于推导个人注射量、频率、疗程、补用、停用或转换。", "source": { "id": "src_5fa0f35fe94cdc3b", "label": "DailyMed（NLM）：LOVENOX 依诺肝素钠当前美国公开标签（Sanofi-Aventis U.S. LLC；SPL v33）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=5017a927-2a24-4f27-89f9-27c805bf7d59", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "LOVENOX 说明书放大阅读：mg、mL、浓度与注射器/药瓶必须一起核对", "en": "LOVENOX label reading: mg, mL, concentration and syringe/vial must be checked together" }, "summary": { "zh": "本模块只帮助阅读当前美国标签中的品牌、通用名、容器、浓度、NDC 和严重风险警示；不生成个人注射量、频率、疗程、漏用补救、停用、转换或联合方案。", "en": "This module only helps read brand, generic name, container, concentration, NDC and serious-risk warnings in the current U.S. label; it does not generate an individual's injection amount, frequency, duration, missed-use action, stopping, switching or combination plan." }, "checks": [ { "zh": "先把 LOVENOX、依诺肝素钠、准确 mg/mL、mg/每支（或每瓶）、容器类型、NDC、目标市场和标签版本一起核对。包装上的 mg、mL 或 mg/mL 是产品身份字段，不是网页可以换算成个人应注射多少的答案。", "en": "Check LOVENOX, enoxaparin sodium, the exact mg/mL, mg per syringe (or vial), container type, NDC, target market and label version together. Milligrams, millilitres and mg/mL on a package identify the product; they are not a web answer for an individual's injection amount." }, { "zh": "单剂量预充式注射器与多剂量瓶是不同容器。即使通用名相同、数字相近或都写“依诺肝素”，也不能自行抽取、转移、分装、补用、共享、按刻度调整或把一种容器换成另一种。", "en": "Single-dose prefilled syringes and a multiple-dose vial are different containers. Even with the same generic name, similar numbers or the same ‘enoxaparin’ wording, do not self-withdraw, transfer, divide, make up, share, adjust by markings or replace one container with another." }, { "zh": "依诺肝素与普通肝素、华法林、阿哌沙班、利伐沙班、阿司匹林、氯吡格雷、布洛芬/萘普生及某些补充剂都可能使完整药单的核对很重要。不要因都写“抗凝”“防血栓”或“止痛”就自行叠加、轮换、暂停或替换。", "en": "Enoxaparin, unfractionated heparin, warfarin, apixaban, rivaroxaban, aspirin, clopidogrel, ibuprofen/naproxen and some supplements can make a complete medicine-list review important. Do not self-combine, alternate, pause or substitute merely because labels mention anticoagulation, clot prevention or pain relief." }, { "zh": "计划做脊柱/硬膜外麻醉、腰穿、手术或牙科操作，或发生跌倒、头部受伤、异常或大量出血、黑便、呕血、明显头晕/晕厥等情况时，应及时联系开方团队或当地紧急医疗支持；网页不决定是否自行停用或何时恢复。", "en": "For planned spinal/epidural anaesthesia, lumbar puncture, surgery or dental procedures, or a fall, head injury, unusual or heavy bleeding, black stools, vomiting blood, marked dizziness/fainting or another acute concern, promptly contact the prescribing team or local urgent-care support; this page does not decide self-stopping or restarting." }, { "zh": "标签中的抗凝机制和包装强度都不能回答某人为什么需要抗凝、何时注射、注射多少、是否能用另一种抗凝药替换，或漏用后如何处理。需要这些答案时，请携带实际包装与完整药单咨询药师或医生。", "en": "Neither the label's anticoagulant mechanism nor package strength can answer why a person needs anticoagulation, when or how much to inject, whether another anticoagulant can replace it, or what to do after a missed use. For those answers, take the actual package and complete medicine list to a pharmacist or clinician." } ], "source": { "id": "src_5fa0f35fe94cdc3b", "label": "DailyMed（NLM）：LOVENOX 依诺肝素钠当前美国公开标签（Sanofi-Aventis U.S. LLC；SPL v33）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=5017a927-2a24-4f27-89f9-27c805bf7d59", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "依诺肝素怎样起作用：标签描述其主要抗 Xa 与抗 IIa 活性", "en": "How enoxaparin works: the label describes predominant anti-factor Xa and anti-factor IIa activity" }, "summary": { "zh": "当前标签将依诺肝素描述为低分子量肝素，其抗凝活性与对抗凝血酶 III 的结合有关，并主要表现为抗 Xa 与抗 IIa 活性。该段只解释标签中的药理路径，不判断任何人是否需要抗凝、个人风险、注射量、时间表、监测、联用或转换。", "en": "The current label describes enoxaparin as a low-molecular-weight heparin whose anticoagulant activity is linked to binding antithrombin III, with predominant anti-factor Xa and anti-factor IIa activity. This explains a label-described pathway, not whether anyone needs anticoagulation, their individual risk, injection amount, schedule, monitoring, co-use or switching." }, "checks": [ { "zh": "“影响凝血因子”不等于网页可以判断胸痛、腿肿、呼吸困难、瘀青、出血或化验结果的原因，也不能替代对血栓、出血、肾功能、体重、年龄、妊娠、手术计划和完整药单的专业评估。", "en": "‘Affects clotting factors’ does not let a webpage determine the cause of chest pain, leg swelling, breathing trouble, bruising, bleeding or a laboratory result, nor replace professional assessment of clotting, bleeding, kidney function, weight, age, pregnancy, procedure plans and the full medicine list." }, { "zh": "同为抗凝药、都作用于凝血路径，或包装上都出现单位/浓度文字，不表示依诺肝素与普通肝素、华法林、直接口服抗凝药、抗血小板药或另一种依诺肝素包装可自行等量替换、叠加、轮换或转换。", "en": "A shared anticoagulant class, clotting-pathway effect or unit/concentration wording on a package does not make enoxaparin self-equivalent, combinable, alternatable or convertible with unfractionated heparin, warfarin, direct oral anticoagulants, antiplatelet medicines or another enoxaparin package." }, { "zh": "机制页面不能处理异常出血、过敏、神经系统症状、疑似误用、手术/硬膜外相关问题或任何急性严重不适。出现此类担忧时，应优先使用当地医生、药师、急诊或紧急支持，而不是依据机制文字自行调整。", "en": "A mechanism page cannot manage unusual bleeding, allergy, neurologic symptoms, suspected misuse, procedure/epidural concerns or another acute severe problem. With these concerns, prioritise local clinicians, pharmacists or urgent support rather than self-adjusting from mechanism text." } ], "source": { "id": "src_5fa0f35fe94cdc3b", "label": "DailyMed（NLM）：LOVENOX 依诺肝素钠当前美国公开标签（Clinical Pharmacology；SPL v33）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=5017a927-2a24-4f27-89f9-27c805bf7d59", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "Lovenox", "generic": "依诺肝素钠", "dosageFormClass": "依诺肝素钠注射液：预充式单剂量注射器及多剂量瓶（当前美国标签所列）" }, "labelSource": { "id": "src_5fa0f35fe94cdc3b", "label": "DailyMed（NLM）：LOVENOX 依诺肝素钠当前美国公开标签（Sanofi-Aventis U.S. LLC；SPL v33）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=5017a927-2a24-4f27-89f9-27c805bf7d59", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "productRoutes": [ { "source": { "id": "src_5fa0f35fe94cdc3b", "label": "DailyMed（NLM）：LOVENOX 依诺肝素钠当前美国公开标签（Sanofi-Aventis U.S. LLC；SPL v33）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=5017a927-2a24-4f27-89f9-27c805bf7d59", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "DailyMed 的 LOVENOX（enoxaparin sodium）当前美国公开标签列出预充式单剂量注射器和 300 mg/3 mL 多剂量瓶，且不同包装可出现 100 mg/mL 或 150 mg/mL 等浓度文字。本页只帮助核对品牌、通用名、准确 mg/mL、容器、NDC、目标市场和标签版本；不把强度或容量变成个人注射量、时间表、漏用补救、停药、转换或与其他抗凝药合用的方案。", "history": "当前美国标签列示 Initial U.S. Approval: 1993。该档案只保留 DailyMed SPL v33（处方信息 2025-05 修订，2026-05-29 发布）的公开阅读入口；不从该文件推定其他市场、其他依诺肝素包装、普通肝素、华法林、口服抗凝药或抗血小板药的当前状态或可替代性。", "sourceDocuments": [ { "id": "src_5fa0f35fe94cdc3b", "label": "DailyMed（NLM）：LOVENOX 依诺肝素钠当前美国公开标签（Sanofi-Aventis U.S. LLC；SPL v33）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=5017a927-2a24-4f27-89f9-27c805bf7d59", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } ], "applicationNumber": "美国标签所列 Initial U.S. Approval: 1993", "approvalTimeline": [ { "date": "1993", "title": { "zh": "当前标签所列美国初始批准年份", "en": "Initial U.S. approval year listed in the current label" }, "detail": { "zh": "当前 LOVENOX 美国标签列示 Initial U.S. Approval: 1993；该年份不自动说明其他市场的批准或产品状态。", "en": "The current U.S. LOVENOX label lists Initial U.S. Approval: 1993; that year does not establish approval or product status in another market." }, "source": { "id": "src_5fa0f35fe94cdc3b", "label": "DailyMed: current LOVENOX public label, SPL v33", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=5017a927-2a24-4f27-89f9-27c805bf7d59", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, { "date": "2025-05", "title": { "zh": "当前处方信息修订月份", "en": "Current prescribing-information revision month" }, "detail": { "zh": "当前标签正文列示 Revised: 5/2025；该日期与 DailyMed 的公开日期分开记录。", "en": "The current label text lists Revised: 5/2025; this remains separate from the DailyMed publication date." }, "source": { "id": "src_5fa0f35fe94cdc3b", "label": "DailyMed: current LOVENOX public label, SPL v33", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=5017a927-2a24-4f27-89f9-27c805bf7d59", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, { "date": "2026-05-29", "title": { "zh": "DailyMed SPL v33 公开", "en": "DailyMed SPL v33 published" }, "detail": { "zh": "DailyMed 将当前 SPL v33 的 Published Date 列为 2026-05-29；不把该日期解释为新的个人治疗建议。", "en": "DailyMed lists 29 May 2026 as the current SPL v33 Published Date; this date is not interpreted as a new individual-treatment recommendation." }, "source": { "id": "src_5fa0f35fe94cdc3b", "label": "DailyMed: current LOVENOX public label, SPL v33", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=5017a927-2a24-4f27-89f9-27c805bf7d59", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "已链接当前公开标签与一个精确包装展示", "en": "Current public label and one exact package panel linked" }, "detail": { "zh": "本档案图只对应 NDC 0075-0620-40 的 40 mg/0.4 mL 十支单剂量预充式注射器；不据此声称实际在售、库存、可获得性或其他包装状态。", "en": "The dossier image corresponds only to the 40 mg/0.4 mL, ten single-dose-syringe panel, NDC 0075-0620-40; it does not establish actual marketing, stock, availability or the status of another package." } }, { "market": { "zh": "中国大陆及其他市场", "en": "Mainland China and other markets" }, "status": { "zh": "待逐项建立市场记录", "en": "Market record not established" }, "detail": { "zh": "不从美国标签推定当地商品名、批准、规格、包装、供应、可替代性或用药安排。", "en": "No local trade name, approval, strength, package, supply, interchangeability or use plan is inferred from the U.S. label." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "40 mg/0.4 mL 是否等于任何人都该注射这一整支？", "en": "Does 40 mg/0.4 mL mean everyone should inject that whole syringe?" }, "answer": { "zh": "不是。这是一个美国标签包装的身份字段。页面不提供个人注射量、频率、疗程或漏用处理；请依据准确处方、手上包装和药师/医生的核对。", "en": "No. It identifies one U.S.-labelled package. This page provides no personal injection amount, frequency, duration or missed-use action; use the exact prescription, package in hand and pharmacist/clinician review." } }, { "question": { "zh": "能否自行用 LOVENOX 替换另一种抗凝或抗血小板药？", "en": "Can LOVENOX self-replace another anticoagulant or antiplatelet medicine?" }, "answer": { "zh": "不能。相同的‘抗凝/防血栓’用途文字并不建立可替代关系。必须由掌握具体原因、手术计划、肾功能、出血风险和完整药单的专业人员逐项核对。", "en": "No. A shared ‘anticoagulation/clot prevention’ description does not establish interchangeability. A professional who knows the specific reason, procedure plan, kidney function, bleeding risk and complete medicine list must review it item by item." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "dosage-forms-are-part-of-medicine-identity", "how-to-read-a-drug-label" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/lovenox/", "en": "https://origindrug.com/en/drugs/lovenox/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "effient", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-23", "status": "published_traceable_archive" }, "names": { "brand": "Effient", "generic": "普拉格雷", "aliases": [ "EFFIENT", "prasugrel", "prasugrel hydrochloride", "普拉格雷", "盐酸普拉格雷", "0713-0881-30", "0713-0882-30" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "抗凝与血液", "sourceArchiveMarket": "美国：DailyMed 公开标签（SPL v2，2022-09-09 发布）。本档案只建立标签明确列出的 EFFIENT 5 mg、10 mg 口服包衣片和各 30 片瓶装身份；不从该资料推定中国大陆、欧盟、日本或其他市场的商品名、批准、供应、可得性或可替代性。", "dosageFormClass": "盐酸普拉格雷口服包衣片：5 mg、10 mg（美国公开标签所列；各 30 片瓶装）", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "2009（DailyMed 公开标签所列美国初始批准）", "archiveSponsorText": "Cosette Pharmaceuticals, Inc.（DailyMed 当前公开标签所列）" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [ "prasugrel 5 mg generic tablet", "prasugrel 10 mg generic tablet", "普拉格雷仿制片", "普拉格雷注射剂" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-effient-prasugrel-tablet-5mg-30-bottle-ndc-0713-0881-30", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v2（2022-09-09 发布）", "en": "DailyMed SPL v2 (published 9 Sep 2022)" }, "dosageForm": { "zh": "EFFIENT 盐酸普拉格雷口服包衣片", "en": "EFFIENT prasugrel hydrochloride coated oral tablet" }, "route": { "zh": "口服（标签产品身份字段）", "en": "oral (label product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 0713-0881-30", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片 5 mg；30 片瓶装（美国标签）", "en": "5 mg labelled per tablet; 30-tablet bottle (U.S. label)" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "普拉格雷", "en": "prasugrel" }, "value": 5, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "5 mg 每片标签标示量；不是个人片数、频率或换算指令", "en": "5 mg labelled per tablet; not an individual's tablet count, frequency or conversion instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "片", "en": "tablets" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-23", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 30, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "黄色", "en": "yellow" }, "shape": { "zh": "长六角形薄膜衣片；无刻痕，不是自行掰开指示", "en": "elongated hexagonal film-coated tablet; unscored, not an instruction to split" }, "imprint": "5121 / 5", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_8907130fa9faeb2b", "label": "DailyMed（NLM）：EFFIENT 盐酸普拉格雷美国公开标签（Cosette；SPL v2，2022-09-09 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=69ea2d58-5353-4222-b61f-cab976fa7e5e", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-effient-prasugrel-tablet-10mg-30-bottle-ndc-0713-0882-30", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v2（2022-09-09 发布）", "en": "DailyMed SPL v2 (published 9 Sep 2022)" }, "dosageForm": { "zh": "EFFIENT 盐酸普拉格雷口服包衣片", "en": "EFFIENT prasugrel hydrochloride coated oral tablet" }, "route": { "zh": "口服（标签产品身份字段）", "en": "oral (label product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 0713-0882-30", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片 10 mg；30 片瓶装（美国标签）", "en": "10 mg labelled per tablet; 30-tablet bottle (U.S. label)" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "普拉格雷", "en": "prasugrel" }, "value": 10, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "10 mg 每片标签标示量；不是个人片数、频率或换算指令", "en": "10 mg labelled per tablet; not an individual's tablet count, frequency or conversion instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "片", "en": "tablets" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-23", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 30, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "米色", "en": "beige" }, "shape": { "zh": "长六角形薄膜衣片；无刻痕，不是自行掰开指示", "en": "elongated hexagonal film-coated tablet; unscored, not an instruction to split" }, "imprint": "5123 / 10", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_8907130fa9faeb2b", "label": "DailyMed（NLM）：EFFIENT 盐酸普拉格雷美国公开标签（Cosette；SPL v2，2022-09-09 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=69ea2d58-5353-4222-b61f-cab976fa7e5e", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "status": "withheld_repackaged_or_non_exact_visual", "title": { "zh": "已核验标签中的准确产品身份，但未保留可一一对应的官方原品牌包装图，故不展示包装图片", "en": "The exact product identity is verified in the label, but no one-to-one official original-brand package visual was retained, so no package image is shown" }, "summary": { "zh": "本档案已核对 DailyMed 公开标签中的 EFFIENT、普拉格雷、5 mg／10 mg 口服包衣片、两个特定 NDC、30 片瓶装和片剂外观线索；但未另行保留能与这两个准确展示面一一对应的官方原品牌包装图。为避免把零售图、版本不明图、其他市场图或非同一规格图片误作准确原品牌包装，页面不展示包装图片，只保留一手标签供放大阅读。", "en": "This dossier checks EFFIENT, prasugrel, 5 mg/10 mg coated oral tablets, two exact NDCs, 30-tablet bottles and tablet appearance clues in the DailyMed public label. However, no official original-brand package visual matching either exact presentation was separately retained. To avoid treating a retail image, version-uncertain image, another-market image or a mismatched-strength image as the exact original-brand pack, the page withholds package imagery and retains the primary label for enlarged reading." }, "source": { "id": "src_8907130fa9faeb2b", "label": "DailyMed（NLM）：EFFIENT 盐酸普拉格雷美国公开标签（Cosette；SPL v2，2022-09-09 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=69ea2d58-5353-4222-b61f-cab976fa7e5e", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "EFFIENT 说明书放大阅读：5 mg／10 mg 先是每片身份，出血或操作问题要交给专业团队", "en": "EFFIENT label reading: 5 mg/10 mg identify each tablet first; bleeding or procedure questions need the professional team" }, "summary": { "zh": "本模块以 DailyMed 美国公开标签为阅读入口，帮助核对 EFFIENT、普拉格雷、每片 5 mg 或 10 mg、准确 NDC、外观线索和 30 片瓶装。它不提供个人片数、漏用处理、停用、与阿司匹林/抗凝药/止痛药联用或围手术期安排。", "en": "This module uses the U.S. DailyMed public label to check EFFIENT, prasugrel, 5 mg or 10 mg per tablet, the exact NDC, appearance clues and a 30-tablet bottle. It does not provide an individual's tablet count, missed-use handling, stopping, use with aspirin/anticoagulants/pain medicines or peri-procedure plan." }, "checks": [ { "zh": "先把 EFFIENT、普拉格雷、5 mg 或 10 mg、NDC、30 片瓶装和目标市场一起核对。mg 是每片标签标示量，不是网页可转成每天几片、两种规格相加、交替使用或由一盒替换另一盒的规则。", "en": "Check EFFIENT, prasugrel, 5 mg or 10 mg, NDC, the 30-tablet bottle and target market together. mg is a labelled per-tablet amount, not a web rule for tablets per day, adding strengths, alternating them or replacing one pack with another." }, { "zh": "该标签列出的 5 mg 与 10 mg 片均无刻痕，并写明不应掰开。这个产品特异的文字不能自动延伸到其他普拉格雷产品、其他市场或其他口服片；吞咽、分片或换药问题应由药师或开方团队按实际产品核对。", "en": "Both 5 mg and 10 mg tablets in this label are unscored, and the label says not to break EFFIENT tablets. This product-specific wording does not automatically extend to another prasugrel product, market or oral tablet; swallowing, splitting or switching questions need pharmacist or prescriber review for the actual product." }, { "zh": "标签有严重出血警示，并提示既往脑卒中/短暂性脑缺血发作、年龄、体重、既往出血、手术或牙科操作及其他药物等信息都需要由了解完整病史和药单的团队判断。它不是让网页据此决定任何人该继续、暂停、补用或转换的清单。", "en": "The label has a serious-bleeding warning and identifies history of stroke/TIA, age, weight, prior bleeding, surgery or dental work and other medicines as information that needs a team with the complete history and medicine list. It is not a checklist for a webpage to decide whether anyone should continue, pause, make up or switch." }, { "zh": "出现明显或不明原因出血、黑便、呕血/咳血、头部受伤、突发胸痛、呼吸困难或神经系统症状时，应使用当地紧急和医疗渠道；不要从本页推断继续、暂停或补用。", "en": "With significant or unexplained bleeding, black stools, vomiting/coughing blood, head injury, sudden chest pain, breathing trouble or neurological symptoms, use local urgent and medical pathways; do not infer continuation, pause or make-up use from this page." } ], "source": { "id": "src_8907130fa9faeb2b", "label": "DailyMed（NLM）：EFFIENT 盐酸普拉格雷美国公开标签（Cosette；Warnings and Dosage Forms）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=69ea2d58-5353-4222-b61f-cab976fa7e5e", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "普拉格雷怎样起作用：活性代谢物不可逆影响血小板 P2Y12 ADP 受体", "en": "How prasugrel works: its active metabolite irreversibly affects the platelet P2Y12 ADP receptor" }, "summary": { "zh": "该美国公开标签描述普拉格雷活性代谢物不可逆结合血小板 P2Y12 ADP 受体，并抑制血小板活化和聚集。这解释药理通路；不判断个人血栓或出血风险、是否适用、何时停用，或如何与其他抗栓产品合用。", "en": "The U.S. public label describes prasugrel's active metabolite as irreversibly binding the platelet P2Y12 ADP receptor and inhibiting platelet activation and aggregation. This explains a pharmacologic pathway; it does not decide individual clot or bleeding risk, suitability, stopping time or use with another antithrombotic product." }, "checks": [ { "zh": "“影响血小板”不表示每一种抗凝、抗血小板或止痛产品都可以自行相加、相换或隔天轮用。产品类别、准确药盒、手术计划和完整药单必须一并由专业人员核对。", "en": "‘Affecting platelets’ does not make every anticoagulant, antiplatelet or pain product self-addable, interchangeable or suitable for alternation. Product class, the exact pack, procedure plans and the complete medicine list must be reviewed together by a professional." }, { "zh": "不可逆性是机制描述，不是“担心出血就可以自行停”的指令。是否暂停、何时恢复或如何处理漏用，取决于准确产品、原因、风险和开方团队的安排。", "en": "Irreversibility is a mechanism description, not an instruction to self-stop when bleeding is feared. Whether to pause, when to restart or how to handle a missed use depends on the exact product, reason, risks and plan from the prescribing team." }, { "zh": "老年人或多药并用时，机制解释尤其不能替代逐项核对：请带上所有药盒、处方标签、非处方药和补充剂，并记下实际服用时间与不适，交由药师或开方团队阅读。", "en": "For older people or people using multiple medicines, a mechanism explanation especially cannot replace item-by-item review: bring all packs, prescription labels, OTC products and supplements, and note actual timing and symptoms for a pharmacist or prescribing team to review." } ], "source": { "id": "src_8907130fa9faeb2b", "label": "DailyMed（NLM）：EFFIENT 盐酸普拉格雷美国公开标签（Cosette；Clinical Pharmacology）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=69ea2d58-5353-4222-b61f-cab976fa7e5e", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "Effient", "generic": "普拉格雷", "dosageFormClass": "盐酸普拉格雷口服包衣片：5 mg、10 mg（美国公开标签所列；各 30 片瓶装）" }, "labelSource": { "id": "src_8907130fa9faeb2b", "label": "DailyMed（NLM）：EFFIENT 盐酸普拉格雷美国公开标签（Cosette；SPL v2，2022-09-09 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=69ea2d58-5353-4222-b61f-cab976fa7e5e", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "productRoutes": [ { "source": { "id": "src_8907130fa9faeb2b", "label": "DailyMed（NLM）：EFFIENT 盐酸普拉格雷美国公开标签（Cosette；SPL v2，2022-09-09 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=69ea2d58-5353-4222-b61f-cab976fa7e5e", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-23", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-23", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "DailyMed 的 EFFIENT（prasugrel hydrochloride）公开标签列有 5 mg、10 mg 口服包衣片，分别为 30 片瓶装。本页以品牌、通用名、每片标示量、NDC、外观线索和一手来源支持药盒核对；不把数字变成个人片数、停用、联用、转换或购买结论。", "history": "本页只建立 DailyMed SPL v2 所列的 EFFIENT 5 mg（NDC 0713-0881-30）与 10 mg（NDC 0713-0882-30）各 30 片瓶装身份。两种片剂均为无刻痕的薄膜衣片；相同药名、颜色、mg 数字或同被称作抗血小板药，都不能决定两盒药能否换用、掰开、与其他抗血小板/抗凝/止痛产品同用，或围手术期如何处理。", "sourceDocuments": [ { "id": "src_8907130fa9faeb2b", "label": "DailyMed（NLM）：EFFIENT 盐酸普拉格雷美国公开标签（Cosette；SPL v2，2022-09-09 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=69ea2d58-5353-4222-b61f-cab976fa7e5e", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, { "id": "src_5ed30b676fbb9773", "label": "FDA Drugs@FDA 官方检索入口", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_lookup_entry", "documentKind": "regulatory_lookup", "market": "US", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } ], "applicationNumber": "NDA 022307", "approvalTimeline": [ { "date": "2009", "title": { "zh": "FDA 标签所列美国初始批准年份", "en": "Initial U.S. approval year listed in the FDA label" }, "detail": { "zh": "本页链接的 FDA 标签档案列示 Initial U.S. Approval: 2009。该历史定位不等同于当前批准、可得性、持有人或其他市场状态。", "en": "The FDA label archive linked here lists Initial U.S. Approval: 2009. This historical locator is not a conclusion about current approval, availability, holder or another market." }, "source": { "id": "src_8907130fa9faeb2b", "label": "DailyMed: EFFIENT prasugrel U.S. public label", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=69ea2d58-5353-4222-b61f-cab976fa7e5e", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" } }, { "date": "DailyMed SPL v2, published 2022-09-09", "title": { "zh": "FDA 标签档案版本", "en": "FDA label archive version" }, "detail": { "zh": "本页链接 DailyMed SPL v2, published 2022-09-09 的 FDA 标签档案作为可复核阅读入口。现行标签、规格、适应症和安全信息必须另行以目标市场当前文件核对。", "en": "This page links the DailyMed SPL v2, published 2022-09-09 FDA label archive as a traceable reading entry point. Current labeling, strength, indication and safety information require separate verification against the target market’s current document." }, "source": { "id": "src_8907130fa9faeb2b", "label": "DailyMed: EFFIENT prasugrel U.S. public label", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=69ea2d58-5353-4222-b61f-cab976fa7e5e", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "已链接公开标签档案", "en": "Public label archive linked" }, "detail": { "zh": "仅对应本页所列 FDA 文件。", "en": "Only the FDA document listed on this page is linked." } }, { "market": { "zh": "中国大陆、欧盟、日本", "en": "Mainland China, EU, Japan" }, "status": { "zh": "待逐项建立市场记录", "en": "Market record not established" }, "detail": { "zh": "不从美国标签档案推定当地批准、持有人、规格、供应或可售资格。", "en": "No local approval, holder, strength, supply or sale-eligibility conclusion is inferred from the U.S. label archive." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "标签档案能代表现在的产品信息吗？", "en": "Does a label archive represent current product information?" }, "answer": { "zh": "不能自动代表。档案用于定位来源；需要以目标市场的现行官方标签逐项复核。", "en": "Not automatically. The archive locates a source; each point needs verification against the target market’s current official label." } }, { "question": { "zh": "为什么这里不展示价格或原研/仿制结论？", "en": "Why are price and originator/generic conclusions not shown?" }, "answer": { "zh": "这些结论需要产品、剂型、规格、包装、市场、日期和原始记录分别齐全并经人工审核；单一标签文件不足以支持。", "en": "Those conclusions require separately complete and human-reviewed product, dosage-form, strength, pack, market, date and primary-record fields; one label file is insufficient." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "how-to-read-a-drug-label", "regulatory-sources-first" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/effient/", "en": "https://origindrug.com/en/drugs/effient/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "cialis", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-23", "status": "published_traceable_archive" }, "names": { "brand": "Cialis", "generic": "他达拉非", "aliases": [ "tadalafil" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "泌尿健康", "sourceArchiveMarket": "美国公开处方药标签档案（DailyMed 页面 2026-06-03 更新；处方信息 2026-03 修订）", "dosageFormClass": "口服薄膜衣片：5 mg、10 mg、20 mg（当前标签的三种供应规格）", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "2003（DailyMed 美国公开标签所列初始批准）", "archiveSponsorText": "Eli Lilly and Company / DailyMed（NLM）公开标签档案" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-cialis-tadalafil-tablet-5mg-30-bottle-ndc-0002446230", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（页面 2026-06-03 更新；处方信息 2026-03 修订）；仅为所引公开标签展示面，不代表供应", "en": "Current U.S. DailyMed public label (page updated 3 Jun 2026; prescribing information revised Mar 2026); cited public label panel only, not availability" }, "dosageForm": { "zh": "CIALIS 他达拉非口服薄膜衣片", "en": "CIALIS tadalafil film-coated oral tablet" }, "route": { "zh": "口服（标签产品身份字段）", "en": "oral (label product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 0002-4462-30", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片他达拉非 5 mg；30 片瓶装", "en": "Tadalafil 5 mg per tablet; 30-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=cialis-5mg-30ct-031-03.jpg&setid=bcd8f8ab-81a2-4891-83db-24a0b0e25895&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "他达拉非", "en": "tadalafil" }, "value": 5, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、分割、转换、停用、联用或换药指令", "en": "labelled amount per tablet; not an individual's tablet count, splitting, conversion, stopping, co-use or switching instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-23", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 30, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "不同深浅的黄色", "en": "different shades of yellow" }, "shape": { "zh": "杏仁形片；不得自行掰开", "en": "almond-shaped tablet; not for self-splitting" }, "imprint": "C 5", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_3f0261dfb62e375b", "label": "DailyMed（NLM）：CIALIS 他达拉非当前美国公开标签（Eli Lilly；页面 2026-06-03 更新；处方信息 2026-03 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=bcd8f8ab-81a2-4891-83db-24a0b0e25895", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-cialis-tadalafil-tablet-10mg-30-bottle-ndc-0002446330", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（页面 2026-06-03 更新；处方信息 2026-03 修订）；仅为所引公开标签展示面，不代表供应", "en": "Current U.S. DailyMed public label (page updated 3 Jun 2026; prescribing information revised Mar 2026); cited public label panel only, not availability" }, "dosageForm": { "zh": "CIALIS 他达拉非口服薄膜衣片", "en": "CIALIS tadalafil film-coated oral tablet" }, "route": { "zh": "口服（标签产品身份字段）", "en": "oral (label product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 0002-4463-30", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片他达拉非 10 mg；30 片瓶装", "en": "Tadalafil 10 mg per tablet; 30-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=cialis-10mg-30ct-032-03.jpg&setid=bcd8f8ab-81a2-4891-83db-24a0b0e25895&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "他达拉非", "en": "tadalafil" }, "value": 10, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、分割、转换、停用、联用或换药指令", "en": "labelled amount per tablet; not an individual's tablet count, splitting, conversion, stopping, co-use or switching instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-23", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 30, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "不同深浅的黄色", "en": "different shades of yellow" }, "shape": { "zh": "杏仁形片；不得自行掰开", "en": "almond-shaped tablet; not for self-splitting" }, "imprint": "C 10", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_3f0261dfb62e375b", "label": "DailyMed（NLM）：CIALIS 他达拉非当前美国公开标签（Eli Lilly；页面 2026-06-03 更新；处方信息 2026-03 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=bcd8f8ab-81a2-4891-83db-24a0b0e25895", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-cialis-tadalafil-tablet-20mg-30-bottle-ndc-0002446430", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（页面 2026-06-03 更新；处方信息 2026-03 修订）；仅为所引公开标签展示面，不代表供应", "en": "Current U.S. DailyMed public label (page updated 3 Jun 2026; prescribing information revised Mar 2026); cited public label panel only, not availability" }, "dosageForm": { "zh": "CIALIS 他达拉非口服薄膜衣片", "en": "CIALIS tadalafil film-coated oral tablet" }, "route": { "zh": "口服（标签产品身份字段）", "en": "oral (label product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 0002-4464-30", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片他达拉非 20 mg；30 片瓶装", "en": "Tadalafil 20 mg per tablet; 30-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=cialis-20mg-30ct-033-03.jpg&setid=bcd8f8ab-81a2-4891-83db-24a0b0e25895&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "他达拉非", "en": "tadalafil" }, "value": 20, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、分割、转换、停用、联用或换药指令", "en": "labelled amount per tablet; not an individual's tablet count, splitting, conversion, stopping, co-use or switching instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-23", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 30, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "不同深浅的黄色", "en": "different shades of yellow" }, "shape": { "zh": "杏仁形片；不得自行掰开", "en": "almond-shaped tablet; not for self-splitting" }, "imprint": "C 20", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_3f0261dfb62e375b", "label": "DailyMed（NLM）：CIALIS 他达拉非当前美国公开标签（Eli Lilly；页面 2026-06-03 更新；处方信息 2026-03 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=bcd8f8ab-81a2-4891-83db-24a0b0e25895", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-cialis-tadalafil-tablet-10mg-30-bottle-ndc-0002446330", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=bcd8f8ab-81a2-4891-83db-24a0b0e25895&name=cialis-10mg-30ct-032-03.jpg", "alt": "CIALIS 他达拉非在美国 DailyMed Eli Lilly 当前公开标签中的 10 mg、NDC 0002-4463-30、30 片纸盒面板", "archiveMarket": "美国", "labelVersion": "DailyMed 当前美国公开标签（页面 2026-06-03 更新；处方信息 2026-03 修订）", "presentation": "CIALIS 薄膜衣片：每片他达拉非 10 mg，NDC 0002-4463-30，30 片瓶装包装面板。", "notice": "此图只对应美国 DailyMed 当前标签中的 CIALIS、他达拉非 10 mg、NDC 0002-4463-30 和 30 片瓶装。它仅帮助核对品牌、通用名、标示强度、片剂、包装数量与来源；不用于鉴定真伪，也不证明 5 mg、20 mg、其他包装、其他市场、当前可得性、原研身份、可替代性或任何个人的分片、联用、开始、停用或使用方案。", "source": { "id": "src_3f0261dfb62e375b", "label": "DailyMed（NLM）：CIALIS 他达拉非当前美国公开标签（Eli Lilly；页面 2026-06-03 更新；处方信息 2026-03 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=bcd8f8ab-81a2-4891-83db-24a0b0e25895", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "CIALIS 说明书放大阅读：5、10、20 mg 先是产品身份", "en": "CIALIS label reading: 5, 10 and 20 mg identify products first" }, "summary": { "zh": "本模块以美国 DailyMed 当前公开标签为阅读入口，帮助核对 CIALIS、他达拉非、口服薄膜衣片、当前包装所列 5 mg、10 mg、20 mg 与标签中的关键风险边界。它不把标签其他位置出现的 2.5 mg 临床/给药文字误作包装身份，也不把任何信息变成个人片数、使用时点、联用、转换或停药建议。", "en": "This module uses the current U.S. DailyMed public label to check CIALIS, tadalafil, oral film-coated tablets, the 5 mg, 10 mg and 20 mg listed current packs, and key risk boundaries. It does not mistake 2.5 mg clinical/dosing text elsewhere in the label for a package identity, or turn any detail into an individual's tablet count, timing, combination, switching or stopping advice." }, "checks": [ { "zh": "先把 CIALIS、他达拉非、准确口服片剂、每片标示强度、实际包装和目标市场一起核对。当前美国标签“供应”部分列的是 5、10、20 mg 三种 30 片瓶装；2.5 mg 出现在标签其他临床/给药文字中，不是这三种包装之一。任何数字都不是网页可以换算成个人应服几片、何时服用或漏用后怎样处理的答案。", "en": "Check CIALIS, tadalafil, the exact oral tablet, stated strength per tablet, actual pack and target market together. The current U.S. label's supply section lists three 30-tablet bottles: 5, 10 and 20 mg; 2.5 mg appears in other clinical/dosing text, not as one of those packages. No number is a web answer for an individual's tablet count, timing or what to do after a missed use." }, { "zh": "标签明确将任何有机硝酸酯列为禁忌，并列出与 α 受体阻断剂、降压药、饮酒及代谢相关药物等需要核对的事项。正在使用胸痛、血压、前列腺、心血管或其他处方/非处方产品时，应让医生或药师连同完整药单和实际包装一起核对；不要自行叠加、轮换、替换或因症状改变用法。", "en": "The label lists any organic nitrate as contraindicated and identifies review considerations involving alpha-blockers, blood-pressure medicines, alcohol and metabolic-interaction medicines. With chest-pain, blood-pressure, prostate, cardiovascular or other prescription/OTC products, have a clinician or pharmacist review the complete medicine list and actual packs together; do not self-combine, alternate, substitute or change use because of symptoms." }, { "zh": "美国标签将不同强度片剂列为不带刻痕的片剂。片上数字、颜色、外形或共同通用名都不授权自行掰开、按经验减半、把两种强度相加，或以另一品牌/另一市场产品替代；准确产品的现行标签和药师才可回答处理方式。", "en": "The U.S. label lists the different strengths as unscored tablets. Tablet numbers, colour, appearance or a shared generic name do not authorise self-splitting, experience-based halving, adding two strengths or substituting another brand/market product; the current label for the exact product and a pharmacist must answer handling questions." }, { "zh": "标签还涉及持续勃起、视力或听力突然变化等需要及时处理的严重情况。出现胸痛、晕厥、明显视力/听力改变、持续异常症状或其他急性担忧时，应使用当地紧急医疗支持；网页不判断是否自行继续、补用、暂停或换药。", "en": "The label also addresses serious situations such as prolonged erection and sudden vision or hearing changes that need prompt attention. With chest pain, fainting, marked vision/hearing change, persistent unusual symptoms or another acute concern, use local urgent medical support; this page does not decide self-continuation, make-up use, pausing or switching." } ], "source": { "id": "src_3f0261dfb62e375b", "label": "DailyMed（NLM）：CIALIS 他达拉非当前美国公开标签（Eli Lilly；页面 2026-06-03 更新；处方信息 2026-03 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=bcd8f8ab-81a2-4891-83db-24a0b0e25895", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "他达拉非怎样起作用：标签将其描述为选择性 PDE5 抑制剂", "en": "How tadalafil works: the label describes it as a selective PDE5 inhibitor" }, "summary": { "zh": "DailyMed 标签将他达拉非描述为一种选择性环磷酸鸟苷（cGMP）特异性 5 型磷酸二酯酶（PDE5）抑制剂。它解释标签中的药理路径，不判断任何人的症状原因、是否适合使用、片数、使用时点、与其他产品联用或转换方案。", "en": "The DailyMed label describes tadalafil as a selective cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5) inhibitor. It explains a label-described pharmacologic pathway, not an individual's symptom cause, suitability, tablet count, timing, co-use with another product or switching plan." }, "checks": [ { "zh": "“PDE5 抑制”是药理类别，不是从网页判断勃起功能、排尿症状、心血管状况或任何不适原因的工具。诊断、是否适用、基础疾病、血压/心血管风险与完整药单均须由专业人员结合目标市场现行标签评估。", "en": "“PDE5 inhibition” is a pharmacologic class, not a tool for deciding the cause of erectile function, urinary symptoms, cardiovascular status or another concern from a webpage. Diagnosis, suitability, underlying conditions, blood-pressure/cardiovascular risk and the complete medicine list require professional assessment with the current target-market label." }, { "zh": "同属 PDE5 抑制剂、都写有相似适用情形或包装数字接近，不表示可以自行与另一种同类产品叠加、轮换、按 mg 换算或替代。标签明确提示与其他 PDE5 抑制剂或勃起功能障碍治疗的合用并不推荐；所有联用与转换问题都要由专业人员核对。", "en": "A shared PDE5-inhibitor class, similar labelled contexts or close package numbers do not permit self-combining, alternating, milligram conversion or substitution with another related product. The label states that use with other PDE5 inhibitors or erectile-dysfunction therapies is not recommended; every co-use and switching question needs professional review." }, { "zh": "机制页面不能把“影响 cGMP 路径”转换成对胸痛、头晕、晕厥、视力/听力变化、持续异常症状或任何急性不适的处理建议。出现急性或严重担忧时，应优先使用当地紧急医疗支持，而不是依据本页自行调整。", "en": "A mechanism page cannot turn “affects a cGMP pathway” into management advice for chest pain, dizziness, fainting, vision/hearing changes, persistent unusual symptoms or any acute concern. With an acute or serious concern, prioritise local urgent medical support rather than self-adjusting from this page." } ], "source": { "id": "src_3f0261dfb62e375b", "label": "DailyMed（NLM）：CIALIS 他达拉非当前美国公开标签（Clinical Pharmacology，Eli Lilly；页面 2026-06-03 更新；处方信息 2026-03 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=bcd8f8ab-81a2-4891-83db-24a0b0e25895", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "Cialis", "generic": "他达拉非", "dosageFormClass": "口服薄膜衣片：5 mg、10 mg、20 mg（当前标签的三种供应规格）" }, "labelSource": { "id": "src_3f0261dfb62e375b", "label": "DailyMed（NLM）：CIALIS 他达拉非当前美国公开标签（Eli Lilly；页面 2026-06-03 更新；处方信息 2026-03 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=bcd8f8ab-81a2-4891-83db-24a0b0e25895", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "productRoutes": [ { "source": { "id": "src_3f0261dfb62e375b", "label": "DailyMed（NLM）：CIALIS 他达拉非当前美国公开标签（Eli Lilly；页面 2026-06-03 更新；处方信息 2026-03 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=bcd8f8ab-81a2-4891-83db-24a0b0e25895", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-23", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_b3d71d76f5c4e092", "label": "FDA：CIALIS 2018 美国处方信息（NDA 021368）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021368s030lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-23", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "DailyMed 的当前 CIALIS（tadalafil）美国公开标签将其列为口服薄膜衣片，并在“供应”部分列出 5 mg、10 mg、20 mg 三种 30 片瓶装。标签正文出现的 2.5 mg 属临床/给药语境，不能被误作当前包装规格。页面帮助读者把品牌、通用名、每片标示强度、准确剂型、实际包装和目标市场一起核对；不据此生成个人片数、给药时点、联用、转换或停药方案。", "history": "本页建立的是 CIALIS 美国公开品牌标签的可回溯阅读入口。标签所列适用情形、禁忌、相互作用与产品强度必须回到手上准确产品及目标市场的现行文件逐项核对；不从本页推定中国大陆或其他市场的当前批准、持有人、供应、可售资格或原研/仿制关系。", "sourceDocuments": [ { "id": "src_3f0261dfb62e375b", "label": "DailyMed（NLM）：CIALIS 他达拉非当前美国公开标签（Eli Lilly；页面 2026-06-03 更新；处方信息 2026-03 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=bcd8f8ab-81a2-4891-83db-24a0b0e25895", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, { "id": "src_b3d71d76f5c4e092", "label": "FDA：CIALIS 2018 美国处方信息（NDA 021368）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021368s030lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } ], "applicationNumber": "NDA 021368", "approvalTimeline": [ { "date": "2003", "title": { "zh": "FDA 标签所列美国初始批准年份", "en": "Initial U.S. approval year listed in the FDA label" }, "detail": { "zh": "本页链接的 FDA 标签档案列示 Initial U.S. Approval: 2003。该历史定位不等同于当前批准、可得性、持有人或其他市场状态。", "en": "The FDA label archive linked here lists Initial U.S. Approval: 2003. This historical locator is not a conclusion about current approval, availability, holder or another market." }, "source": { "id": "src_3f0261dfb62e375b", "label": "DailyMed: CIALIS current U.S. public label", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=bcd8f8ab-81a2-4891-83db-24a0b0e25895", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" } }, { "date": "2026-06-03", "title": { "zh": "FDA 标签档案版本", "en": "FDA label archive version" }, "detail": { "zh": "本页链接 2026-06-03 的 FDA 标签档案作为可复核阅读入口。现行标签、规格、适应症和安全信息必须另行以目标市场当前文件核对。", "en": "This page links the 2026-06-03 FDA label archive as a traceable reading entry point. Current labeling, strength, indication and safety information require separate verification against the target market’s current document." }, "source": { "id": "src_3f0261dfb62e375b", "label": "DailyMed: CIALIS current U.S. public label", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=bcd8f8ab-81a2-4891-83db-24a0b0e25895", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "已链接公开标签档案", "en": "Public label archive linked" }, "detail": { "zh": "仅对应本页所列 FDA 文件。", "en": "Only the FDA document listed on this page is linked." } }, { "market": { "zh": "中国大陆、欧盟、日本", "en": "Mainland China, EU, Japan" }, "status": { "zh": "待逐项建立市场记录", "en": "Market record not established" }, "detail": { "zh": "不从美国标签档案推定当地批准、持有人、规格、供应或可售资格。", "en": "No local approval, holder, strength, supply or sale-eligibility conclusion is inferred from the U.S. label archive." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "标签档案能代表现在的产品信息吗？", "en": "Does a label archive represent current product information?" }, "answer": { "zh": "不能自动代表。档案用于定位来源；需要以目标市场的现行官方标签逐项复核。", "en": "Not automatically. The archive locates a source; each point needs verification against the target market’s current official label." } }, { "question": { "zh": "为什么这里不展示价格或原研/仿制结论？", "en": "Why are price and originator/generic conclusions not shown?" }, "answer": { "zh": "这些结论需要产品、剂型、规格、包装、市场、日期和原始记录分别齐全并经人工审核；单一标签文件不足以支持。", "en": "Those conclusions require separately complete and human-reviewed product, dosage-form, strength, pack, market, date and primary-record fields; one label file is insufficient." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "how-to-read-a-drug-label", "regulatory-sources-first" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/cialis/", "en": "https://origindrug.com/en/drugs/cialis/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "myrbetriq", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-17", "status": "published_traceable_archive" }, "names": { "brand": "Myrbetriq", "generic": "米拉贝隆", "aliases": [ "mirabegron", "贝坦利" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "泌尿健康", "sourceArchiveMarket": "美国公开处方药标签档案", "dosageFormClass": "口服缓释片：25 mg、50 mg；另有缓释口服混悬液颗粒，属于不同产品形态（本档案所列）", "dosageFormClassCode": "oral_modified_release", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "2012（DailyMed 美国公开标签所列初始批准）", "archiveSponsorText": "Astellas Pharma US, Inc. / DailyMed（NLM）公开标签档案" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-myrbetriq-mirabegron-er-tablet-25mg-30-bottle-carton-ndc-0469-2601-30", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前公开标签（SPL v17，2024-08-20 发布）", "en": "DailyMed current public label (SPL v17, published 20 Aug 2024)" }, "dosageForm": { "zh": "MYRBETRIQ 米拉贝隆缓释口服片", "en": "MYRBETRIQ mirabegron extended-release oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 0469-2601-30", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "米拉贝隆 25 mg 缓释片；30 片瓶装纸盒", "en": "Mirabegron 25 mg extended-release tablet; 30-tablet bottle carton" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=image-06.jpg&setid=ba9e9e15-e666-4c56-9271-2e24739cfa2d&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "米拉贝隆", "en": "mirabegron" }, "value": 25, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、掰开、压碎、联用或换药规则", "en": "labelled amount per tablet; not an individual's tablet count, splitting, crushing, combination or switching rule" } } ], "concentration": null, "container": { "typeCode": "carton_with_bottle", "typeLabel": { "zh": "含 30 片瓶装的纸盒", "en": "carton containing a 30-tablet bottle" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "片/瓶装纸盒", "en": "tablets per bottle carton" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-23", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 30, "unit": { "zh": "片/瓶装纸盒", "en": "tablets per bottle carton" } }, "physicalClues": { "color": { "zh": "棕色（标签所列）", "en": "brown (listed in label)" }, "shape": { "zh": "椭圆形薄膜衣缓释片；无刻痕，不是自行掰开指示", "en": "oval film-coated extended-release tablet; unscored, not a self-splitting instruction" }, "imprint": { "zh": "Astellas 标识 / 325", "en": "Astellas logo / 325" }, "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_137c4858d2e07094", "label": "DailyMed（NLM）：MYRBETRIQ 米拉贝隆 25 mg、30 片瓶装纸盒当前美国公开标签（Astellas；SPL v17，2024-08-20 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ba9e9e15-e666-4c56-9271-2e24739cfa2d", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-myrbetriq-mirabegron-er-tablet-50mg-30-bottle-carton-ndc-0469-2602-30", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前公开标签（SPL v17，2024-08-20 发布）", "en": "DailyMed current public label (SPL v17, published 20 Aug 2024)" }, "dosageForm": { "zh": "MYRBETRIQ 米拉贝隆缓释口服片", "en": "MYRBETRIQ mirabegron extended-release oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 0469-2602-30", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "米拉贝隆 50 mg 缓释片；30 片瓶装纸盒", "en": "Mirabegron 50 mg extended-release tablet; 30-tablet bottle carton" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=image-07.jpg&setid=ba9e9e15-e666-4c56-9271-2e24739cfa2d&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "米拉贝隆", "en": "mirabegron" }, "value": 50, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、掰开、压碎、联用或换药规则", "en": "labelled amount per tablet; not an individual's tablet count, splitting, crushing, combination or switching rule" } } ], "concentration": null, "container": { "typeCode": "carton_with_bottle", "typeLabel": { "zh": "含 30 片瓶装的纸盒", "en": "carton containing a 30-tablet bottle" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "片/瓶装纸盒", "en": "tablets per bottle carton" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-23", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 30, "unit": { "zh": "片/瓶装纸盒", "en": "tablets per bottle carton" } }, "physicalClues": { "color": { "zh": "黄色（标签所列）", "en": "yellow (listed in label)" }, "shape": { "zh": "椭圆形薄膜衣缓释片；无刻痕，不是自行掰开指示", "en": "oval film-coated extended-release tablet; unscored, not a self-splitting instruction" }, "imprint": { "zh": "Astellas 标识 / 355", "en": "Astellas logo / 355" }, "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_137c4858d2e07094", "label": "DailyMed（NLM）：MYRBETRIQ 米拉贝隆 50 mg、30 片瓶装纸盒当前美国公开标签（Astellas；SPL v17，2024-08-20 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ba9e9e15-e666-4c56-9271-2e24739cfa2d", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-myrbetriq-mirabegron-er-tablet-25mg-30-bottle-carton-ndc-0469-2601-30", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=image-06.jpg&setid=ba9e9e15-e666-4c56-9271-2e24739cfa2d&type=img", "alt": "MYRBETRIQ 米拉贝隆在美国 DailyMed Astellas 公开标签中的 25 mg、30 片缓释片纸盒图", "archiveMarket": "美国", "labelVersion": "DailyMed 公开标签（Astellas Pharma US, Inc.，2024-08 更新）", "presentation": "MYRBETRIQ 米拉贝隆缓释片：每片 25 mg、30 片装纸盒图（NDC 0469-2601-30；DailyMed Astellas 公开标签所列）。", "notice": "此为美国 DailyMed Astellas 公开标签中明确对应 MYRBETRIQ、米拉贝隆 25 mg、30 片缓释片装的纸盒图，只帮助核对品牌、通用名、缓释片、标示强度、包装数量和来源；不用于鉴定真伪，也不证明 50 mg、缓释口服混悬液颗粒、其他包装、其他市场标签、当前可得性、原研身份、目标市场批准或可售资格。", "source": { "id": "src_137c4858d2e07094", "label": "DailyMed（NLM）：MYRBETRIQ 米拉贝隆公开标签（Astellas Pharma US, Inc.，2024-08 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ba9e9e15-e666-4c56-9271-2e24739cfa2d", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "MYRBETRIQ 说明书放大阅读：25 mg、50 mg 与“缓释片”必须一起读", "en": "MYRBETRIQ label reading: read 25 mg, 50 mg and ‘extended-release tablet’ together" }, "summary": { "zh": "本模块以美国 DailyMed 公开标签和包装图为阅读入口，帮助核对 MYRBETRIQ、米拉贝隆、25 mg/50 mg 缓释片及目标市场。它不提供个人片数、开始/停止、联用或症状处理方案。", "en": "This module uses the U.S. DailyMed public label and package image to check MYRBETRIQ, mirabegron, 25 mg/50 mg extended-release tablets and target market. It does not provide an individual's tablet count, start/stop, combination or symptom-management plan." }, "checks": [ { "zh": "25 mg 或 50 mg 是每片标示强度，不是网页给任何人计算今天应服几片的答案。先同时核对品牌、通用名、缓释片、每片强度、包装和所在市场。", "en": "25 mg or 50 mg is a labelled strength per tablet, not a web answer to how many tablets anyone should take today. Check brand, generic name, extended-release tablet, strength per tablet, package and market together." }, { "zh": "该标签写明缓释片应整片吞服，不要切开、压碎或咀嚼。不能把“一片掰成两半”当作自动减半，也不能把缓释片与同名缓释口服混悬液颗粒按 mg 对 mg 自行换算或替换。", "en": "The label says the extended-release tablet is swallowed whole and not cut, crushed or chewed. A split tablet is not an automatic half-dose, and the tablet must not be self-converted or substituted milligram-for-milligram with same-name extended-release oral-suspension granules." }, { "zh": "标签含血压、尿潴留、过敏性肿胀和部分联用药物的警示。已有高血压、排尿困难、其他泌尿系统用药、心血管药、完整处方/非处方药与补充剂时，应让医生或药师结合实际药盒核对；不要因“膀胱用药”文字自行叠加或轮换。", "en": "The label includes warnings involving blood pressure, urinary retention, allergic swelling and some co-medications. With high blood pressure, difficulty urinating, other urinary medicines, cardiovascular medicines or any prescription/OTC medicine and supplements, have a clinician or pharmacist review the actual pack; do not self-add or alternate based on bladder-use wording." } ], "source": { "id": "src_137c4858d2e07094", "label": "DailyMed（NLM）：MYRBETRIQ 米拉贝隆缓释片/缓释口服混悬液颗粒公开标签（Astellas Pharma US, Inc.，2024-08 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ba9e9e15-e666-4c56-9271-2e24739cfa2d", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "米拉贝隆怎样起作用：标签把它归为 β3 肾上腺素能受体激动剂", "en": "How mirabegron works: the label classifies it as a beta-3 adrenergic agonist" }, "summary": { "zh": "DailyMed 标签将 MYRBETRIQ／MYRBETRIQ Granules 归为 β3 肾上腺素能受体激动剂。机制文字只帮助理解药物类别与标签中的产品边界；它不判断个人症状原因、是否适合使用、片数、联用或转换方案。", "en": "The DailyMed label classifies MYRBETRIQ/MYRBETRIQ Granules as beta-3 adrenergic agonists. Mechanism wording only helps explain drug class and product boundaries; it does not determine a person's symptom cause, suitability, tablet count, combination or switching plan." }, "checks": [ { "zh": "“β3 受体激动剂”是药理路径，不是对尿频、尿急、漏尿、排尿困难或腹痛的自我诊断，也不能取代检查和专业判断。", "en": "‘Beta-3 agonist’ is a pharmacologic pathway, not a self-diagnosis for frequency, urgency, leakage, difficult urination or abdominal pain, and cannot replace evaluation or professional judgement." }, { "zh": "共同作用于泌尿系统或名称相似，不支持将米拉贝隆与坦索罗辛、抗胆碱能药或任何其他药物自行叠加、隔天轮换或替代；应以完整药单和现行标签复核。", "en": "A shared urinary-system context or similar name does not support self-combining, alternate-day rotation or substitution of mirabegron with tamsulosin, an antimuscarinic medicine or any other product; review the complete medicine list and current label." }, { "zh": "出现面部、嘴唇、舌或咽喉肿胀、呼吸困难、晕厥或其他急性严重不适时，应优先使用当地紧急医疗支持，而不是依据机制文字自行继续、换药或加量。", "en": "With swelling of the face, lips, tongue or throat, breathing difficulty, fainting or another acute severe concern, prioritise local emergency care rather than self-continuing, switching or escalating from mechanism wording." } ], "source": { "id": "src_137c4858d2e07094", "label": "DailyMed（NLM）：MYRBETRIQ 米拉贝隆公开标签（临床药理与警示）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ba9e9e15-e666-4c56-9271-2e24739cfa2d", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "Myrbetriq", "generic": "米拉贝隆", "dosageFormClass": "口服缓释片：25 mg、50 mg；另有缓释口服混悬液颗粒，属于不同产品形态（本档案所列）" }, "labelSource": { "id": "src_137c4858d2e07094", "label": "DailyMed（NLM）：MYRBETRIQ 米拉贝隆缓释片/缓释口服混悬液颗粒公开标签（Astellas Pharma US, Inc.，2024-08 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ba9e9e15-e666-4c56-9271-2e24739cfa2d", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "productRoutes": [ { "source": { "id": "src_137c4858d2e07094", "label": "DailyMed（NLM）：MYRBETRIQ 米拉贝隆缓释片/缓释口服混悬液颗粒公开标签（Astellas Pharma US, Inc.，2024-08 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ba9e9e15-e666-4c56-9271-2e24739cfa2d", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-23", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-23", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "DailyMed 的 MYRBETRIQ（mirabegron）美国公开标签将口服缓释片列为 25 mg 或 50 mg，并另列缓释口服混悬液颗粒。页面帮助读者把品牌、通用名、准确剂型、标示强度、包装和目标市场一起核对；不据此生成个人片数、加减量、联用、换药或停药方案。", "history": "同写“米拉贝隆”不表示缓释片与缓释口服混悬液颗粒可按 mg 对 mg 自行换算或互换。25 mg、50 mg、片剂和口服混悬液描述的是准确产品的身份字段；页面不把这些数字转换成任何人的服用数量。", "sourceDocuments": [ { "id": "src_137c4858d2e07094", "label": "DailyMed（NLM）：MYRBETRIQ 米拉贝隆缓释片/缓释口服混悬液颗粒公开标签（Astellas Pharma US, Inc.，2024-08 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ba9e9e15-e666-4c56-9271-2e24739cfa2d", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, { "id": "src_5ed30b676fbb9773", "label": "FDA Drugs@FDA 官方检索入口", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_lookup_entry", "documentKind": "regulatory_lookup", "market": "US", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } ], "applicationNumber": "NDA 202611（DailyMed 公开标签所列美国市场标识）", "approvalTimeline": [ { "date": "2012", "title": { "zh": "FDA 标签所列美国初始批准年份", "en": "Initial U.S. approval year listed in the FDA label" }, "detail": { "zh": "本页链接的 FDA 标签档案列示 Initial U.S. Approval: 2012。该历史定位不等同于当前批准、可得性、持有人或其他市场状态。", "en": "The FDA label archive linked here lists Initial U.S. Approval: 2012. This historical locator is not a conclusion about current approval, availability, holder or another market." }, "source": { "id": "src_137c4858d2e07094", "label": "DailyMed: MYRBETRIQ public label archive", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ba9e9e15-e666-4c56-9271-2e24739cfa2d", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" } }, { "date": "2024-08", "title": { "zh": "FDA 标签档案版本", "en": "FDA label archive version" }, "detail": { "zh": "本页链接 2024-08 的 FDA 标签档案作为可复核阅读入口。现行标签、规格、适应症和安全信息必须另行以目标市场当前文件核对。", "en": "This page links the 2024-08 FDA label archive as a traceable reading entry point. Current labeling, strength, indication and safety information require separate verification against the target market’s current document." }, "source": { "id": "src_137c4858d2e07094", "label": "DailyMed: MYRBETRIQ public label archive", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ba9e9e15-e666-4c56-9271-2e24739cfa2d", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "已链接公开标签档案", "en": "Public label archive linked" }, "detail": { "zh": "仅对应本页所列 FDA 文件。", "en": "Only the FDA document listed on this page is linked." } }, { "market": { "zh": "中国大陆、欧盟、日本", "en": "Mainland China, EU, Japan" }, "status": { "zh": "待逐项建立市场记录", "en": "Market record not established" }, "detail": { "zh": "不从美国标签档案推定当地批准、持有人、规格、供应或可售资格。", "en": "No local approval, holder, strength, supply or sale-eligibility conclusion is inferred from the U.S. label archive." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "标签档案能代表现在的产品信息吗？", "en": "Does a label archive represent current product information?" }, "answer": { "zh": "不能自动代表。档案用于定位来源；需要以目标市场的现行官方标签逐项复核。", "en": "Not automatically. The archive locates a source; each point needs verification against the target market’s current official label." } }, { "question": { "zh": "为什么这里不展示价格或原研/仿制结论？", "en": "Why are price and originator/generic conclusions not shown?" }, "answer": { "zh": "这些结论需要产品、剂型、规格、包装、市场、日期和原始记录分别齐全并经人工审核；单一标签文件不足以支持。", "en": "Those conclusions require separately complete and human-reviewed product, dosage-form, strength, pack, market, date and primary-record fields; one label file is insufficient." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "how-to-read-a-drug-label", "regulatory-sources-first" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/myrbetriq/", "en": "https://origindrug.com/en/drugs/myrbetriq/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "vesicare", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-20", "status": "published_traceable_archive" }, "names": { "brand": "VESIcare", "generic": "琥珀酸索利那新", "aliases": [ "solifenacin", "solifenacin succinate", "索利那新", "卫喜康" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "泌尿健康", "sourceArchiveMarket": "美国 DailyMed 当前公开处方药标签：5 mg、10 mg 薄膜衣片各有已链接 30 片纸盒展示面（SPL v30，2026-01-21 发布）；中国大陆安斯泰来公开说明书（2024-10 修订）仅覆盖其列示的琥珀酸索利那新片 5 mg，须与实际包装和现行标签分别核对", "dosageFormClass": "美国当前公开标签：口服薄膜衣片 5 mg、10 mg；中国大陆安斯泰来公开说明书：5 mg 薄膜衣片（须分别核对）；VESICARE LS 口服混悬液不并入本片剂档案", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "2004（DailyMed 美国公开标签所列初始批准）", "archiveSponsorText": "Astellas Pharma US, Inc. / DailyMed（NLM）公开标签档案；安斯泰来中国公开说明书与新闻稿" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [ "VESICARE LS", "solifenacin oral suspension", "索利那新口服混悬液" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-vesicare-tablet-5mg-ndc-51248-150-01", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v30，2026-01-21 发布", "en": "DailyMed SPL v30, published 21 Jan 2026" }, "dosageForm": { "zh": "VESIcare 索利那新琥珀酸盐薄膜衣口服片", "en": "VESIcare solifenacin succinate film-coated oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 51248-150-01", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片 5 mg；30 片纸盒装", "en": "5 mg per tablet; 30-tablet carton" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=image-02.jpg&archiveid=941878", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "琥珀酸索利那新", "en": "solifenacin succinate" }, "value": 5, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标示量；不是个人片数", "en": "labelled amount per tablet; not an individual tablet count" } } ], "concentration": null, "container": { "typeCode": "carton", "typeLabel": { "zh": "30 片纸盒装", "en": "30-tablet carton" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "片/盒", "en": "tablets per carton" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": null, "package": { "count": 30, "unit": { "zh": "片/盒", "en": "tablets per carton" } }, "physicalClues": { "color": { "zh": "粉红与白色纸盒展示面", "en": "pink-and-white carton display panel" }, "shape": { "zh": "薄膜衣片", "en": "film-coated tablet" }, "imprint": null, "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_936f0dc18cc4942d", "label": "DailyMed（NLM）：VESICARE 索利那新琥珀酸盐薄膜衣片当前美国公开标签（Astellas；SPL v30，2026-01-21 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=9acee910-cdb2-4052-b8b3-c26aff1c8716", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-vesicare-tablet-10mg-ndc-51248-151-01", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v30，2026-01-21 发布", "en": "DailyMed SPL v30, published 21 Jan 2026" }, "dosageForm": { "zh": "VESIcare 索利那新琥珀酸盐薄膜衣口服片", "en": "VESIcare solifenacin succinate film-coated oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 51248-151-01", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片 10 mg；30 片纸盒装", "en": "10 mg per tablet; 30-tablet carton" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=image-03.jpg&archiveid=941878", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "琥珀酸索利那新", "en": "solifenacin succinate" }, "value": 10, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标示量；不是个人片数", "en": "labelled amount per tablet; not an individual tablet count" } } ], "concentration": null, "container": { "typeCode": "carton", "typeLabel": { "zh": "30 片纸盒装", "en": "30-tablet carton" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "片/盒", "en": "tablets per carton" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": null, "package": { "count": 30, "unit": { "zh": "片/盒", "en": "tablets per carton" } }, "physicalClues": { "color": { "zh": "灰色与白色纸盒展示面", "en": "grey-and-white carton display panel" }, "shape": { "zh": "薄膜衣片", "en": "film-coated tablet" }, "imprint": null, "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_936f0dc18cc4942d", "label": "DailyMed（NLM）：VESICARE 索利那新琥珀酸盐薄膜衣片当前美国公开标签（Astellas；SPL v30，2026-01-21 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=9acee910-cdb2-4052-b8b3-c26aff1c8716", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-vesicare-tablet-5mg-ndc-51248-150-01", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=image-02.jpg&archiveid=941878", "alt": "VESIcare 索利那新在美国 DailyMed Astellas 公开标签中的 5 mg、30 片装纸盒展开图", "archiveMarket": "美国", "labelVersion": "DailyMed SPL v30（2026-01-21 发布）", "presentation": "VESIcare 索利那新琥珀酸盐薄膜衣片：每片 5 mg、30 片装纸盒展开图（NDC 51248-150-01；DailyMed Astellas 公开标签所列）。", "notice": "此图只对应美国 DailyMed 当前标签中 VESIcare、索利那新琥珀酸盐 5 mg、NDC 51248-150-01 与 30 片纸盒装。它只帮助核对品牌、通用名、每片标示量、薄膜衣片、包装数量与来源；不用于鉴定真伪，也不证明 10 mg、VESICARE LS 口服混悬液、其他包装、其他市场、当前可得性、原研身份、可替代性或任何个人的片数、联用、开始、停用或换药方案。", "source": { "id": "src_936f0dc18cc4942d", "label": "DailyMed（NLM）：VESICARE 索利那新琥珀酸盐薄膜衣片当前美国公开标签（Astellas；SPL v30，2026-01-21 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=9acee910-cdb2-4052-b8b3-c26aff1c8716", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "VESIcare 说明书放大阅读：5 mg、10 mg、薄膜衣片与包装要一起核对", "en": "VESIcare label reading: check 5 mg, 10 mg, film-coated tablet and package together" }, "summary": { "zh": "本模块以美国 DailyMed 公开标签和 5 mg、30 片纸盒展开图为阅读入口，帮助核对 VESIcare、索利那新、每片标示量、口服薄膜衣片和目标市场。它不提供个人片数、开始/停止、联用或症状处理方案。", "en": "This module uses the U.S. DailyMed public label and 5 mg/30-tablet carton dieline to check VESIcare, solifenacin, stated strength per tablet, film-coated oral tablet and target market. It does not provide an individual's tablet count, start/stop, combination or symptom-management plan." }, "checks": [ { "zh": "先把 VESIcare、索利那新、5 mg 或 10 mg、口服薄膜衣片、包装数量和目标市场一起核对。毫克数是每片的标示身份信息，不是网页给任何人计算今天应服几片的答案。", "en": "Check VESIcare, solifenacin, 5 mg or 10 mg, film-coated oral tablet, package quantity and target market together. Milligrams identify the stated amount per tablet; they are not a web answer to how many tablets anyone should use today." }, { "zh": "这份标签要求按准确产品的说明整片吞服。不能把药名、颜色、规格或纸盒图当作可自行掰开、研碎、拼用或替换的依据；应让药师或开方人员核对实际包装和现行标签。", "en": "This label directs swallowing the exact product whole. A name, colour, strength or carton image does not establish that a tablet may be self-split, crushed, combined or substituted; have a pharmacist or prescriber check the actual pack and current label." }, { "zh": "标签涉及尿潴留、胃肠道问题、窄角型青光眼、中枢神经系统影响和部分强效 CYP3A4 抑制剂等边界。已有排尿困难、便秘、眼科问题、肾肝问题或多种处方/非处方药和补充剂时，应携带完整药单请医生或药师复核；不要因“膀胱用药”文字自行叠加、轮换或停药。", "en": "The label includes boundaries involving urinary retention, gastrointestinal conditions, narrow-angle glaucoma, central-nervous-system effects and some potent CYP3A4 inhibitors. With difficult urination, constipation, an eye condition, kidney/liver concerns or multiple prescription/OTC medicines and supplements, take the complete list to a clinician or pharmacist; do not self-add, alternate or stop because of a ‘bladder medicine’ label." } ], "source": { "id": "src_76b9ef0ca1ca83f8", "label": "安斯泰来中国：卫喜康®／琥珀酸索利那新片公开说明书（2024-10 修订）", "url": "https://www.astellas.com.cn/system/files/solifenacin-tab_chn-prescriber_china_20241026.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "first_party_leaflet", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "索利那新怎样起作用：标签将它归为毒蕈碱受体拮抗剂", "en": "How solifenacin works: the label classifies it as a muscarinic receptor antagonist" }, "summary": { "zh": "DailyMed 标签将 VESIcare 描述为毒蕈碱受体拮抗剂。机制文字帮助理解这一个标签中的药物类别与警示边界；它不判断个人尿频、尿急、漏尿、排尿困难或腹痛的原因，也不决定是否适合使用、片数、联用或转换。", "en": "The DailyMed label describes VESIcare as a muscarinic receptor antagonist. Mechanism wording helps explain the class and warning boundaries in this label; it does not determine the cause of frequency, urgency, leakage, difficult urination or abdominal pain, nor suitability, tablet count, combination or switching." }, "checks": [ { "zh": "“毒蕈碱受体拮抗剂”是药理分类，不是对任何排尿、腹部或眼部症状的自我诊断，也不替代检查和专业判断。", "en": "‘Muscarinic receptor antagonist’ is a pharmacologic classification, not a self-diagnosis for urinary, abdominal or eye symptoms, and it cannot replace evaluation or professional judgement." }, { "zh": "作用于相近症状或出现相似的“泌尿”文字，不支持把索利那新与米拉贝隆、坦索罗辛、抗胆碱能药或任何其他产品自行叠加、隔天轮换或替代；应以完整药单和现行标签复核。", "en": "A similar symptom context or urinary wording does not support self-combining, alternate-day rotation or substitution of solifenacin with mirabegron, tamsulosin, an anticholinergic medicine or any other product; review the complete medicine list and current label." }, { "zh": "出现面部、嘴唇、舌或咽喉肿胀、呼吸困难、晕厥或其他急性严重不适时，应优先使用当地紧急医疗支持，而不是依据机制文字自行继续、换药或加量。", "en": "With swelling of the face, lips, tongue or throat, breathing difficulty, fainting or another acute severe concern, prioritise local emergency care rather than self-continuing, switching or escalating from mechanism wording." } ], "source": { "id": "src_76b9ef0ca1ca83f8", "label": "安斯泰来中国：卫喜康®／琥珀酸索利那新片公开说明书（2024-10 修订）", "url": "https://www.astellas.com.cn/system/files/solifenacin-tab_chn-prescriber_china_20241026.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "first_party_leaflet", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "VESIcare", "generic": "琥珀酸索利那新", "dosageFormClass": "美国当前公开标签：口服薄膜衣片 5 mg、10 mg；中国大陆安斯泰来公开说明书：5 mg 薄膜衣片（须分别核对）；VESICARE LS 口服混悬液不并入本片剂档案" }, "labelSource": { "id": "src_76b9ef0ca1ca83f8", "label": "安斯泰来中国：卫喜康®／琥珀酸索利那新片公开说明书（2024-10 修订）", "url": "https://www.astellas.com.cn/system/files/solifenacin-tab_chn-prescriber_china_20241026.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "first_party_leaflet", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "productRoutes": [ { "source": { "id": "src_76b9ef0ca1ca83f8", "label": "安斯泰来中国：卫喜康®／琥珀酸索利那新片公开说明书（2024-10 修订）", "url": "https://www.astellas.com.cn/system/files/solifenacin-tab_chn-prescriber_china_20241026.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "first_party_leaflet", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "status": "manufacturer_public_label_verified", "authority": { "zh": "安斯泰来中国", "en": "Astellas China" }, "market": { "zh": "中国大陆", "en": "Mainland China" }, "recordType": { "zh": "企业公开处方资料", "en": "Manufacturer public prescribing material" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_7333c9a1d28a174d", "label": "DailyMed（NLM）：VESICARE 索利那新琥珀酸盐薄膜衣片公开标签（Astellas Pharma US, Inc.，2022-10 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=9acee910-cdb2-4052-b8b3-c26aff1c8716", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "manufacturer_public_label_verified", "authority": { "zh": "安斯泰来中国", "en": "Astellas China" }, "market": { "zh": "中国大陆", "en": "Mainland China" }, "recordType": { "zh": "企业公开处方资料", "en": "Manufacturer public prescribing material" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "DailyMed 的 VESIcare（solifenacin succinate）美国公开标签列示 5 mg、10 mg 口服薄膜衣片；安斯泰来中国的公开说明书列示卫喜康®／琥珀酸索利那新片 5 mg。页面帮助读者把品牌、通用名、每片标示量、剂型、包装、目标市场与说明书版本一起核对；不据此生成个人片数、服用时间、联用、转换或停药方案。", "history": "5 mg、10 mg 和 30 片包装是这一美国公开标签下的准确产品身份线索；中国公开说明书列示的是 5 mg 薄膜衣片。它们都不是网页给任何人计算用量的答案。即使名称相同，另一个市场、规格、包装或标签版本也应重新逐项核对。", "sourceDocuments": [ { "id": "src_7333c9a1d28a174d", "label": "DailyMed（NLM）：VESICARE 索利那新琥珀酸盐薄膜衣片公开标签（Astellas Pharma US, Inc.，2022-10 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=9acee910-cdb2-4052-b8b3-c26aff1c8716", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_76b9ef0ca1ca83f8", "label": "安斯泰来中国：卫喜康®／琥珀酸索利那新片公开说明书（2024-10 修订）", "url": "https://www.astellas.com.cn/system/files/solifenacin-tab_chn-prescriber_china_20241026.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "first_party_leaflet", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_f8ab587fec165beb", "label": "安斯泰来中国：卫喜康®列入原研药组合的新闻稿（2021）", "url": "https://www.astellas.com.cn/system/files/news/2021-11/%E6%B7%B1%E5%8C%96%E5%90%88%E4%BD%9C%EF%BC%8C%E5%85%B1%E8%B5%A2%E5%8F%91%E5%B1%95%EF%BC%81%E5%AE%89%E6%96%AF%E6%B3%B0%E6%9D%A5%E6%90%BA%E6%89%8B%E7%99%BE%E6%B4%8B%E5%8C%BB%E8%8D%AF%E5%85%B1%E6%8E%A8%E6%B3%8C%E5%B0%BF%E9%A2%86%E5%9F%9F%E6%B2%BB%E7%96%97%E8%8D%AF%E7%89%A9%E5%95%86%E4%B8%9A%E5%8C%96-CN.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "first_party_release", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } ], "applicationNumber": "NDA 021518（DailyMed 公开标签所列美国市场标识）", "approvalTimeline": [ { "date": "2004", "title": { "zh": "FDA 标签所列美国初始批准年份", "en": "Initial U.S. approval year listed in the FDA label" }, "detail": { "zh": "本页链接的 FDA 标签档案列示 Initial U.S. Approval: 2004。该历史定位不等同于当前批准、可得性、持有人或其他市场状态。", "en": "The FDA label archive linked here lists Initial U.S. Approval: 2004. This historical locator is not a conclusion about current approval, availability, holder or another market." }, "source": { "id": "src_7333c9a1d28a174d", "label": "DailyMed: VESICARE public label archive", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=9acee910-cdb2-4052-b8b3-c26aff1c8716", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, { "date": "2022-10", "title": { "zh": "FDA 标签档案版本", "en": "FDA label archive version" }, "detail": { "zh": "本页链接 2022-10 的 FDA 标签档案作为可复核阅读入口。现行标签、规格、适应症和安全信息必须另行以目标市场当前文件核对。", "en": "This page links the 2022-10 FDA label archive as a traceable reading entry point. Current labeling, strength, indication and safety information require separate verification against the target market’s current document." }, "source": { "id": "src_7333c9a1d28a174d", "label": "DailyMed: VESICARE public label archive", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=9acee910-cdb2-4052-b8b3-c26aff1c8716", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "已链接公开标签档案", "en": "Public label archive linked" }, "detail": { "zh": "仅对应本页所列 FDA 文件。", "en": "Only the FDA document listed on this page is linked." } }, { "market": { "zh": "中国大陆、欧盟、日本", "en": "Mainland China, EU, Japan" }, "status": { "zh": "待逐项建立市场记录", "en": "Market record not established" }, "detail": { "zh": "不从美国标签档案推定当地批准、持有人、规格、供应或可售资格。", "en": "No local approval, holder, strength, supply or sale-eligibility conclusion is inferred from the U.S. label archive." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "标签档案能代表现在的产品信息吗？", "en": "Does a label archive represent current product information?" }, "answer": { "zh": "不能自动代表。档案用于定位来源；需要以目标市场的现行官方标签逐项复核。", "en": "Not automatically. The archive locates a source; each point needs verification against the target market’s current official label." } }, { "question": { "zh": "为什么这里不展示价格或原研/仿制结论？", "en": "Why are price and originator/generic conclusions not shown?" }, "answer": { "zh": "这些结论需要产品、剂型、规格、包装、市场、日期和原始记录分别齐全并经人工审核；单一标签文件不足以支持。", "en": "Those conclusions require separately complete and human-reviewed product, dosage-form, strength, pack, market, date and primary-record fields; one label file is insufficient." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "how-to-read-a-drug-label", "regulatory-sources-first" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/vesicare/", "en": "https://origindrug.com/en/drugs/vesicare/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "altace", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-28", "status": "published_traceable_archive" }, "names": { "brand": "ALTACE", "generic": "雷米普利", "aliases": [ "ALTACE", "ramipril", "雷米普利", "NDA 019901", "Altace 1.25 mg", "Altace 2.5 mg", "Altace 5 mg", "Altace 10 mg", "019901" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "心血管", "sourceArchiveMarket": "美国 ALTACE（ramipril）NDA 019901 原品牌监管档案与 DailyMed SPL v29 当前公开标签", "dosageFormClass": "ALTACE 雷米普利硬明胶口服胶囊：1.25、2.5、5、10 mg；胶囊无刻痕。当前美国标签对准确 ALTACE 胶囊另有整粒吞服或打开后与指定少量食物/液体混合的说明，本页不把它扩大到其他胶囊或转换为个人剂量方案", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "1991-01-28（美国 NDA 019901 初始上市记录）", "archiveSponsorText": "美国 NDA 019901 原品牌历史；当前 DailyMed 标签列示 Pfizer Laboratories Div Pfizer Inc；实时供应与其他市场状态须另行核验" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [ "ramipril tablet", "ramipril generic capsule", "generic ramipril", "雷米普利片", "雷米普利通用名胶囊", "other ACE inhibitor", "其他 ACE 抑制剂" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-altace-ramipril-1-25mg-100-capsule-bottle-ndc-6157011001", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v29（2026-05-19 生效）", "en": "DailyMed SPL v29 (effective 19 May 2026)" }, "dosageForm": { "zh": "ALTACE 雷米普利硬明胶口服胶囊", "en": "ALTACE ramipril hard gelatin oral capsule" }, "route": { "zh": "口服（标签产品身份字段）", "en": "oral (label product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 61570-110-01", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_capsule", "primaryDisplay": { "zh": "每粒雷米普利 1.25 mg；NDC 61570-110-01；100 粒瓶装", "en": "Ramipril 1.25 mg per capsule; NDC 61570-110-01; 100-capsule bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=altace-05.jpg&archiveid=963585", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "雷米普利", "en": "ramipril" }, "value": 1.25, "unit": "mg", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒标签标示量；不是个人粒数、频率或换算指令", "en": "labelled amount per capsule; not an individual's capsule count, frequency or conversion instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "粒", "en": "capsules" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-28", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "physicalClues": { "color": { "zh": "黄色", "en": "yellow" }, "shape": { "zh": "胶囊形；无刻痕", "en": "capsule-shaped; no score" }, "imprint": "Altace 1 25 mg MP", "scoreStatus": "not_scored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_23769c710c78f985", "label": "DailyMed（NLM）：ALTACE 雷米普利 1.25 mg、100 粒瓶装美国公开标签面板", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=0fc34cd8-86e6-4034-73bd-4263a68ba046", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-altace-ramipril-2-5mg-100-capsule-bottle-ndc-6157011101", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v29（2026-05-19 生效）", "en": "DailyMed SPL v29 (effective 19 May 2026)" }, "dosageForm": { "zh": "ALTACE 雷米普利硬明胶口服胶囊", "en": "ALTACE ramipril hard gelatin oral capsule" }, "route": { "zh": "口服（标签产品身份字段）", "en": "oral (label product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 61570-111-01", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_capsule", "primaryDisplay": { "zh": "每粒雷米普利 2.5 mg；NDC 61570-111-01；100 粒瓶装", "en": "Ramipril 2.5 mg per capsule; NDC 61570-111-01; 100-capsule bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=altace-06.jpg&archiveid=963585", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "雷米普利", "en": "ramipril" }, "value": 2.5, "unit": "mg", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒标签标示量；不是个人粒数、频率或换算指令", "en": "labelled amount per capsule; not an individual's capsule count, frequency or conversion instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "粒", "en": "capsules" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-28", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "physicalClues": { "color": { "zh": "橙色", "en": "orange" }, "shape": { "zh": "胶囊形；无刻痕", "en": "capsule-shaped; no score" }, "imprint": "Altace 2 5 mg MP", "scoreStatus": "not_scored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_23769c710c78f985", "label": "DailyMed（NLM）：ALTACE 雷米普利 2.5 mg、100 粒瓶装美国公开标签面板", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=0fc34cd8-86e6-4034-73bd-4263a68ba046", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-altace-ramipril-5mg-100-capsule-bottle-ndc-6157011201", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v29（2026-05-19 生效）", "en": "DailyMed SPL v29 (effective 19 May 2026)" }, "dosageForm": { "zh": "ALTACE 雷米普利硬明胶口服胶囊", "en": "ALTACE ramipril hard gelatin oral capsule" }, "route": { "zh": "口服（标签产品身份字段）", "en": "oral (label product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 61570-112-01", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_capsule", "primaryDisplay": { "zh": "每粒雷米普利 5 mg；NDC 61570-112-01；100 粒瓶装", "en": "Ramipril 5 mg per capsule; NDC 61570-112-01; 100-capsule bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=altace-07.jpg&archiveid=963585", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "雷米普利", "en": "ramipril" }, "value": 5, "unit": "mg", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒标签标示量；不是个人粒数、频率或换算指令", "en": "labelled amount per capsule; not an individual's capsule count, frequency or conversion instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "粒", "en": "capsules" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-28", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "physicalClues": { "color": { "zh": "红色", "en": "red" }, "shape": { "zh": "胶囊形；无刻痕", "en": "capsule-shaped; no score" }, "imprint": "Altace 5 mg MP", "scoreStatus": "not_scored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_23769c710c78f985", "label": "DailyMed（NLM）：ALTACE 雷米普利 5 mg、100 粒瓶装美国公开标签面板", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=0fc34cd8-86e6-4034-73bd-4263a68ba046", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-altace-ramipril-10mg-100-capsule-bottle-ndc-6157012001", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v29（2026-05-19 生效）", "en": "DailyMed SPL v29 (effective 19 May 2026)" }, "dosageForm": { "zh": "ALTACE 雷米普利硬明胶口服胶囊", "en": "ALTACE ramipril hard gelatin oral capsule" }, "route": { "zh": "口服（标签产品身份字段）", "en": "oral (label product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 61570-120-01", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_capsule", "primaryDisplay": { "zh": "每粒雷米普利 10 mg；NDC 61570-120-01；100 粒瓶装", "en": "Ramipril 10 mg per capsule; NDC 61570-120-01; 100-capsule bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=altace-08.jpg&archiveid=963585", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "雷米普利", "en": "ramipril" }, "value": 10, "unit": "mg", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒标签标示量；不是个人粒数、频率或换算指令", "en": "labelled amount per capsule; not an individual's capsule count, frequency or conversion instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "粒", "en": "capsules" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-28", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "physicalClues": { "color": { "zh": "蓝色", "en": "blue" }, "shape": { "zh": "胶囊形；无刻痕", "en": "capsule-shaped; no score" }, "imprint": "Altace 10 mg MP", "scoreStatus": "not_scored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_23769c710c78f985", "label": "DailyMed（NLM）：ALTACE 雷米普利 10 mg、100 粒瓶装美国公开标签面板", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=0fc34cd8-86e6-4034-73bd-4263a68ba046", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-altace-ramipril-5mg-100-capsule-bottle-ndc-6157011201", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=altace-07.jpg&archiveid=963585", "alt": "ALTACE 雷米普利在美国 DailyMed 当前标签中的 5 mg、NDC 61570-112-01、100 粒瓶装展示面", "archiveMarket": "美国", "labelVersion": "DailyMed SPL v29（2026-05-19 生效）", "presentation": "ALTACE 雷米普利：每粒 5 mg，NDC 61570-112-01，100 粒瓶装展示面。", "notice": "此图只对应美国 DailyMed 当前标签中的 ALTACE、雷米普利 5 mg、NDC 61570-112-01 与 100 粒瓶装。它只帮助核对商品名、通用名、每粒标示量、胶囊、包装数量、刻印和来源；不用于鉴定真伪，也不证明其他规格、其他包装、其他市场、实时库存、原研身份、可替代性，或任何个人的粒数、频率、打开胶囊、停药、联用或换药方案。", "source": { "id": "src_23769c710c78f985", "label": "DailyMed（NLM）：ALTACE 雷米普利 5 mg、100 粒瓶装美国公开标签面板", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=0fc34cd8-86e6-4034-73bd-4263a68ba046", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "ALTACE／雷米普利说明书放大阅读：先看每粒毫克数，再看胶囊能否打开", "en": "ALTACE/ramipril label reading: check milligrams per capsule, then the exact capsule-opening boundary" }, "summary": { "zh": "当前美国标签把 ALTACE 列为雷米普利 1.25、2.5、5、10 mg 硬明胶胶囊。mg 是每粒标示量，不是网页给出的个人粒数。胶囊没有可供“掰半”的刻痕；标签对准确 ALTACE 胶囊另有打开后混合的产品专属说明，但不能据此推断其他雷米普利或其他胶囊也能打开。", "en": "The current U.S. label lists ALTACE as hard gelatin ramipril capsules in 1.25, 2.5, 5 and 10 mg strengths. mg is the labelled amount per capsule, not a personal capsule count generated by the site. A capsule has no score to split in half. The label has a product-specific opening-and-mixing option for exact ALTACE capsules, which does not establish that another ramipril or another capsule may be opened." }, "checks": [ { "zh": "同时核对 ALTACE、雷米普利、口服胶囊、1.25/2.5/5/10 mg、NDC、颜色、刻印和目标市场。不要把雷米普利片、通用名胶囊、依那普利、卡托普利、赖诺普利或沙坦类当成同一产品。", "en": "Check ALTACE, ramipril, oral capsule, 1.25/2.5/5/10 mg, NDC, colour, imprint and target market together. Do not treat a ramipril tablet, generic capsule, enalapril, captopril, lisinopril or an ARB as the same product." }, { "zh": "1.25、2.5、5、10 mg 都表示每粒标示量；个人用量还需结合处方、适应症、血压、肾功能、钾、年龄、脱水和完整药单。网页不能把一个规格换算成几粒或一日总量。", "en": "1.25, 2.5, 5 and 10 mg each state the labelled amount per capsule. Individual use also depends on the prescription, indication, blood pressure, kidney function, potassium, age, volume status and complete medicine list; the site cannot convert a strength into a capsule count or daily total." }, { "zh": "当前标签一般写整粒吞服，也允许准确 ALTACE 胶囊打开后把全部内容与约 4 oz 苹果酱、120 mL 水或苹果汁混合并全部摄入。此处只解释标签原文：吞咽困难、喂养管、储存、其他品牌或儿童使用仍须先让药师核对，不能把胶囊内容目测分半。", "en": "The current label generally says to swallow the capsule whole and also permits the exact ALTACE capsule to be opened, with all contents mixed into about 4 oz of applesauce or 120 mL of water or apple juice and consumed in full. This only explains the source label. Swallowing difficulty, feeding tubes, storage, another brand or paediatric use still require pharmacist review, and capsule contents must not be divided by eye." }, { "zh": "把利尿药、补钾、含钾盐替代品、布洛芬/萘普生等 NSAIDs、锂、其他 ACE 抑制剂、沙坦类、阿利吉仑和沙库巴曲/缬沙坦放在同一张药单复核；不要自行叠加、错开、轮换、停用或替换。", "en": "Place diuretics, potassium supplements, potassium-containing salt substitutes, NSAIDs such as ibuprofen/naproxen, lithium, other ACE inhibitors, ARBs, aliskiren and sacubitril/valsartan on one list for review. Do not self-combine, separate, alternate, stop or substitute." }, { "zh": "面部、嘴唇、舌头或喉部肿胀，呼吸或吞咽困难，昏厥或其他严重急性问题需要立即使用当地急救服务；不要等待网页判断。怀孕或可能怀孕也应尽快联系开方团队，因为美国标签含胎儿毒性加框警示。", "en": "Swelling of the face, lips, tongue or throat, breathing or swallowing difficulty, fainting or another severe acute problem requires immediate local emergency help; do not wait for a website decision. Pregnancy or possible pregnancy also requires prompt contact with the prescribing team because the U.S. label carries a boxed warning for fetal toxicity." } ], "source": { "id": "src_23769c710c78f985", "label": "DailyMed（NLM）：ALTACE 雷米普利当前美国公开标签（SPL v29，2026-05-19 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=0fc34cd8-86e6-4034-73bd-4263a68ba046", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "雷米普利怎样起作用：前体药转化为雷米普利拉，再抑制 ACE", "en": "How ramipril works: a prodrug converted to ramiprilat, then ACE inhibition" }, "summary": { "zh": "当前标签说明雷米普利经酯酶水解为活性代谢物雷米普利拉。它抑制 ACE，减少血管紧张素 II 的形成并降低醛固酮分泌，帮助理解为什么血压、肾功能、钾、脱水和相互作用需要一起看；该机制不能预测个人反应或决定用量。", "en": "The current label explains that ramipril is hydrolysed by esterases to the active metabolite ramiprilat. ACE inhibition reduces formation of angiotensin II and lowers aldosterone secretion, helping explain why blood pressure, kidney function, potassium, volume status and interactions need review together; the mechanism cannot predict individual response or determine an amount." }, "checks": [ { "zh": "同属 ACE 抑制剂不表示雷米普利可与依那普利、卡托普利或赖诺普利自行合用、按毫克换算或隔日轮换；与沙坦类或沙库巴曲/缬沙坦也必须按准确药物和现行标签核对。", "en": "Sharing the ACE-inhibitor class does not make ramipril self-combinable, milligram-convertible or alternate-day interchangeable with enalapril, captopril or lisinopril; ARBs and sacubitril/valsartan also require exact medicine- and current-label review." }, { "zh": "干咳、头晕、乏力、排尿变化或检查异常不能仅凭机制归因，也不能成为自行停药、补服或换另一种降压药的理由；请带实际药盒和完整药单联系专业人员。", "en": "Dry cough, dizziness, weakness, urine change or an abnormal test cannot be attributed from mechanism alone and is not a reason to self-stop, redose or change to another blood-pressure medicine; take the actual pack and complete medicine list to a professional." }, { "zh": "机制词不能替代血压、肾功能、电解质、妊娠状态和完整药单的临床判断；若有面舌喉肿胀、呼吸困难、昏厥或其他严重急性问题，应立即使用当地急救支持。", "en": "Mechanism terms do not replace clinical review of blood pressure, kidney function, electrolytes, pregnancy status and the complete medicine list. Face/tongue/throat swelling, breathing difficulty, fainting or another severe acute problem requires immediate local emergency support." } ], "source": { "id": "src_23769c710c78f985", "label": "DailyMed（NLM）：ALTACE 当前美国公开标签（临床药理与作用机制）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=0fc34cd8-86e6-4034-73bd-4263a68ba046", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "ALTACE", "generic": "雷米普利", "dosageFormClass": "ALTACE 雷米普利硬明胶口服胶囊：1.25、2.5、5、10 mg；胶囊无刻痕。当前美国标签对准确 ALTACE 胶囊另有整粒吞服或打开后与指定少量食物/液体混合的说明，本页不把它扩大到其他胶囊或转换为个人剂量方案" }, "labelSource": { "id": "src_23769c710c78f985", "label": "DailyMed（NLM）：ALTACE 雷米普利当前美国公开标签（Pfizer；SPL v29，2026-05-19 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=0fc34cd8-86e6-4034-73bd-4263a68ba046", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" }, "productRoutes": [ { "source": { "id": "src_23769c710c78f985", "label": "DailyMed（NLM）：ALTACE 雷米普利当前美国公开标签（Pfizer；SPL v29，2026-05-19 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=0fc34cd8-86e6-4034-73bd-4263a68ba046", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-28", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_a1437b72a96c9176", "label": "FDA Drugs@FDA：ALTACE（ramipril）NDA 019901 当前申请记录", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=019901", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" }, "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-08-28", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-28", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "ALTACE 是雷米普利的美国原品牌档案。当前美国公开标签列出 1.25、2.5、5、10 mg 四种口服硬明胶胶囊。页面优先帮助老人分清品牌、通用名、每粒毫克数、胶囊能否打开的产品专属边界，以及与其他 ACE 抑制剂、沙坦、沙库巴曲/缬沙坦、利尿药、补钾、锂和 NSAIDs 的药单核对；不生成个人粒数、频率、停药、联用或换药方案。", "history": "DailyMed 当前标签把 ALTACE 的初始美国批准记录为 1991，并在产品数据中列出 NDA019901 与 1991-01-28 的营销起始日期。SPL v29 于 2026-05-19 生效，列示 Pfizer、四种 100 粒瓶装展示面和 2026 年修订的血管性水肿警示。网页把原始批准历史、当前标签、具体 NDC 的历史营销日期和实时供应严格分开。", "sourceDocuments": [ { "id": "src_a1437b72a96c9176", "label": "FDA Drugs@FDA：ALTACE（ramipril）NDA 019901 当前申请记录", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=019901", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" }, { "id": "src_23769c710c78f985", "label": "DailyMed（NLM）：ALTACE 雷米普利当前美国公开标签（Pfizer；SPL v29，2026-05-19 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=0fc34cd8-86e6-4034-73bd-4263a68ba046", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" } ], "applicationNumber": "FDA NDA 019901（ALTACE / ramipril；美国原品牌监管档案）", "approvalTimeline": [ { "date": "1991-01-28", "title": { "zh": "ALTACE 胶囊美国初始上市记录", "en": "Initial U.S. marketing record for ALTACE capsules" }, "detail": { "zh": "DailyMed 当前 NDA 品牌标签把 ALTACE 的初始美国批准列为 1991，并在产品数据中把 NDA019901 与 1991-01-28 的营销起始日期连接。该历史节点只建立美国产品史，不自动建立其他市场的品牌、批准、供应或可替代性。", "en": "The current DailyMed NDA brand label lists ALTACE's initial U.S. approval as 1991 and links NDA019901 to a marketing start date of 28 Jan 1991 in its product data. This historical node establishes U.S. product history only and does not automatically establish another market's brand, approval, supply or interchangeability." }, "source": { "id": "src_23769c710c78f985", "label": "DailyMed（NLM）：ALTACE 雷米普利当前美国公开标签（初始批准与产品数据）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=0fc34cd8-86e6-4034-73bd-4263a68ba046", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" } }, { "date": "2026-05-19", "title": { "zh": "当前美国 ALTACE SPL v29 生效", "en": "Current U.S. ALTACE SPL v29 effective" }, "detail": { "zh": "当前 DailyMed 标签列示 ALTACE、NDA019901、Pfizer、1.25/2.5/5/10 mg 硬明胶胶囊、准确 NDC、颜色、刻印和四种瓶装展示面，并更新血管性水肿警示。页面把标签版本、具体 NDC 的历史营销日期与实时库存和购买严格分开。", "en": "The current DailyMed label lists ALTACE, NDA019901, Pfizer, hard gelatin 1.25/2.5/5/10 mg capsules, exact NDCs, colours, imprints and four bottle display panels, and updates the angioedema warning. The page keeps label version and historical NDC marketing dates separate from live stock and purchase." }, "source": { "id": "src_23769c710c78f985", "label": "DailyMed（NLM）：ALTACE 雷米普利当前美国公开标签（SPL v29）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=0fc34cd8-86e6-4034-73bd-4263a68ba046", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "当前 NDA 品牌标签和四种 100 粒瓶装展示面已链接；实时供应未建立", "en": "Current NDA brand label and four 100-capsule bottle panels linked; live supply not established" }, "detail": { "zh": "分别记录 1.25、2.5、5、10 mg 的 NDC、颜色、ALTACE/MP 刻印、无刻痕和来源。DailyMed 产品数据还列有不同 NDC 的历史营销结束日期，因此本页不把“当前标签”写成“当前有货”，也不用于鉴定真伪、购买或决定个人粒数、频率、打开胶囊、停药、联用或换药。", "en": "The dossier separately records NDC, colour, ALTACE/MP imprint, no-score status and source for 1.25, 2.5, 5 and 10 mg. DailyMed product data also lists historical marketing end dates for individual NDCs, so a current label is not described as current stock. The record does not authenticate, sell or decide an individual's capsule count, frequency, capsule opening, stopping, co-use or switching." } }, { "market": { "zh": "中国大陆、欧盟、日本及其他市场", "en": "Mainland China, the EU, Japan and other markets" }, "status": { "zh": "待逐项建立现行监管产品记录", "en": "Current regulatory product record not established" }, "detail": { "zh": "不从美国 ALTACE 名称、NDA、共同通用名、NDC、毫克数、胶囊颜色、刻印或包装图推定当地商品名、批准、包装、供应、原研/参比关系或可替代性；每个市场须按当地现行监管资料逐产品核对。", "en": "No local trade name, approval, package, supply, originator/reference relationship or interchangeability is inferred from the U.S. ALTACE name, NDA, shared generic name, NDC, milligram value, capsule colour, imprint or package image; each product requires current local regulatory review." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "ALTACE、雷米普利、依那普利和卡托普利是一回事吗？", "en": "Are ALTACE, ramipril, enalapril and captopril the same thing?" }, "answer": { "zh": "ALTACE 是所引美国雷米普利产品的商品名，雷米普利是通用名；依那普利和卡托普利是不同成分。即使都属于 ACE 抑制剂，也不能据此自行叠加、轮换、按毫克换算或替代。请用实际药盒、处方和完整药单由药师或开方团队核对。", "en": "ALTACE is the trade name of the cited U.S. ramipril product, while ramipril is the generic name; enalapril and captopril are different ingredients. Even though all are ACE inhibitors, that does not support self-combining, alternating, milligram conversion or substitution. Have a pharmacist or prescriber review the actual packs, prescription and complete medicine list." } }, { "question": { "zh": "ALTACE 是胶囊，能否打开或分成一半？", "en": "ALTACE is a capsule; can it be opened or divided in half?" }, "answer": { "zh": "当前美国标签对准确 ALTACE 胶囊有整粒吞服或打开后把全部内容与指定少量食物/液体混合并全部摄入的说明，但这不等于可以目测分半，也不适用于其他雷米普利胶囊、其他品牌、其他剂型、喂养管或个人情况。先核对手中准确产品和处方，再请药师确认。", "en": "The current U.S. label for the exact ALTACE capsule describes swallowing whole or opening it and mixing all contents with a specified small amount of food or liquid for complete consumption. That does not permit division by eye and does not apply automatically to another ramipril capsule, brand, dosage form, feeding tube or individual context. Check the exact product and prescription, then confirm with a pharmacist." } }, { "question": { "zh": "药单里已有缬沙坦、沙库巴曲/缬沙坦、利尿药、布洛芬或补钾，可以一起用吗？", "en": "Can ALTACE be used with valsartan, sacubitril/valsartan, a diuretic, ibuprofen or potassium?" }, "answer": { "zh": "网页不能判断个人能否同用。这些名称提示需要把全部处方药、非处方止痛药、补充剂、含钾盐替代品、血压、肾功能和电解质一起交给药师或开方团队逐项核对；不要自行叠加、错开、隔日轮换、停用或替换。", "en": "The site cannot decide individual co-use. These names signal that all prescriptions, OTC pain medicines, supplements, potassium-containing salt substitutes, blood pressure, kidney function and electrolytes need item-by-item review by a pharmacist or prescriber; do not self-combine, separate, alternate by day, stop or substitute." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "dosage-forms-are-part-of-medicine-identity", "how-to-read-a-drug-label" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/altace/", "en": "https://origindrug.com/en/drugs/altace/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "arcoxia", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-28", "status": "published_traceable_archive" }, "names": { "brand": "ARCOXIA", "generic": "依托考昔", "aliases": [ "ARCOXIA", "Arcoxia", "etoricoxib", "依托考昔", "ARTG 131797", "ARTG 81456", "ARTG 204147", "ARTG 81458" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "疼痛与炎症", "sourceArchiveMarket": "澳大利亚：TGA 当前 ARTG 公开记录分别列示 ARCOXIA etoricoxib 30 mg、60 mg、90 mg、120 mg tablet blister pack，Licence status 均为 A，并提供 Product Information（PI）和 Consumer Medicine Information（CMI）入口。本页不从澳大利亚记录推定中国大陆、美国、欧盟、日本或其他市场的批准、商品名、包装、供应、可售资格、原研/仿制关系或可替代性。", "dosageFormClass": "依托考昔 30 mg、60 mg、90 mg、120 mg 薄膜衣口服片；TGA ARTG 所列泡罩包装", "dosageFormClassCode": "oral_solid", "route": "口服（产品身份字段）", "routeCode": "oral", "historicalApprovalEntry": "2002-10-11（澳大利亚 TGA 60 mg、120 mg ARTG 登记日期；30 mg 为 2008-04-11，90 mg 为 2013-11-05）", "archiveSponsorText": "ORGANON PHARMA PTY LTD（四项 TGA ARTG 当前公开记录所列 sponsor）" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [ "celecoxib", "塞来昔布", "meloxicam", "美洛昔康", "ibuprofen", "布洛芬", "naproxen", "萘普生", "other etoricoxib product", "其他依托考昔产品", "other market package", "其他市场包装" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "au-arcoxia-etoricoxib-30mg-tablet-blister-artg-131797", "marketCode": "AU", "labelVersion": { "zh": "TGA ARTG 131797（2026-08-28 核验）", "en": "TGA ARTG 131797 (verified 28 Aug 2026)" }, "dosageForm": { "zh": "ARCOXIA 依托考昔薄膜衣口服片", "en": "ARCOXIA etoricoxib film-coated oral tablet" }, "route": { "zh": "口服（产品身份字段）", "en": "oral (product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "ARTG 131797", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片依托考昔 30 mg；泡罩包装（澳大利亚 TGA ARTG）", "en": "Etoricoxib 30 mg per tablet; blister pack (Australian TGA ARTG)" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "依托考昔", "en": "etoricoxib" }, "value": 30, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、频率、疗程或换算指令", "en": "labelled amount per tablet; not an individual's tablet count, frequency, course or conversion instruction" } } ], "concentration": null, "container": { "typeCode": "blister_pack", "typeLabel": { "zh": "泡罩包装", "en": "blister pack" }, "fill": null, "countPerPackage": null, "countUnit": null }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-28", "currentLabelDisplayed": true, "ndcDirectoryListed": false, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": null, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_ec52afb15f35a6bd", "label": "澳大利亚 TGA：ARCOXIA 依托考昔 30 mg 片泡罩包装（ARTG 131797）", "url": "https://www.tga.gov.au/resources/artg/131797", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "au-arcoxia-etoricoxib-60mg-tablet-blister-artg-81456", "marketCode": "AU", "labelVersion": { "zh": "TGA ARTG 81456（2026-08-28 核验）", "en": "TGA ARTG 81456 (verified 28 Aug 2026)" }, "dosageForm": { "zh": "ARCOXIA 依托考昔薄膜衣口服片", "en": "ARCOXIA etoricoxib film-coated oral tablet" }, "route": { "zh": "口服（产品身份字段）", "en": "oral (product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "ARTG 81456", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片依托考昔 60 mg；泡罩包装（澳大利亚 TGA ARTG）", "en": "Etoricoxib 60 mg per tablet; blister pack (Australian TGA ARTG)" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "依托考昔", "en": "etoricoxib" }, "value": 60, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、频率、疗程或换算指令", "en": "labelled amount per tablet; not an individual's tablet count, frequency, course or conversion instruction" } } ], "concentration": null, "container": { "typeCode": "blister_pack", "typeLabel": { "zh": "泡罩包装", "en": "blister pack" }, "fill": null, "countPerPackage": null, "countUnit": null }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-28", "currentLabelDisplayed": true, "ndcDirectoryListed": false, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": null, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_0e3e8c55d792ac01", "label": "澳大利亚 TGA：ARCOXIA 依托考昔 60 mg 片泡罩包装（ARTG 81456）", "url": "https://www.tga.gov.au/resources/artg/81456", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "au-arcoxia-etoricoxib-90mg-tablet-blister-artg-204147", "marketCode": "AU", "labelVersion": { "zh": "TGA ARTG 204147（2026-08-28 核验）", "en": "TGA ARTG 204147 (verified 28 Aug 2026)" }, "dosageForm": { "zh": "ARCOXIA 依托考昔薄膜衣口服片", "en": "ARCOXIA etoricoxib film-coated oral tablet" }, "route": { "zh": "口服（产品身份字段）", "en": "oral (product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "ARTG 204147", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片依托考昔 90 mg；泡罩包装（澳大利亚 TGA ARTG）", "en": "Etoricoxib 90 mg per tablet; blister pack (Australian TGA ARTG)" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "依托考昔", "en": "etoricoxib" }, "value": 90, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、频率、疗程或换算指令", "en": "labelled amount per tablet; not an individual's tablet count, frequency, course or conversion instruction" } } ], "concentration": null, "container": { "typeCode": "blister_pack", "typeLabel": { "zh": "泡罩包装", "en": "blister pack" }, "fill": null, "countPerPackage": null, "countUnit": null }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-28", "currentLabelDisplayed": true, "ndcDirectoryListed": false, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": null, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_7c07425503a5cbb9", "label": "澳大利亚 TGA：ARCOXIA 依托考昔 90 mg 片泡罩包装（ARTG 204147）", "url": "https://www.tga.gov.au/resources/artg/204147", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "au-arcoxia-etoricoxib-120mg-tablet-blister-artg-81458", "marketCode": "AU", "labelVersion": { "zh": "TGA ARTG 81458（2026-08-28 核验）", "en": "TGA ARTG 81458 (verified 28 Aug 2026)" }, "dosageForm": { "zh": "ARCOXIA 依托考昔薄膜衣口服片", "en": "ARCOXIA etoricoxib film-coated oral tablet" }, "route": { "zh": "口服（产品身份字段）", "en": "oral (product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "ARTG 81458", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片依托考昔 120 mg；泡罩包装（澳大利亚 TGA ARTG）", "en": "Etoricoxib 120 mg per tablet; blister pack (Australian TGA ARTG)" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "依托考昔", "en": "etoricoxib" }, "value": 120, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、频率、疗程或换算指令", "en": "labelled amount per tablet; not an individual's tablet count, frequency, course or conversion instruction" } } ], "concentration": null, "container": { "typeCode": "blister_pack", "typeLabel": { "zh": "泡罩包装", "en": "blister pack" }, "fill": null, "countPerPackage": null, "countUnit": null }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-28", "currentLabelDisplayed": true, "ndcDirectoryListed": false, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": null, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_103e8f7bd192a28f", "label": "澳大利亚 TGA：ARCOXIA 依托考昔 120 mg 片泡罩包装（ARTG 81458）", "url": "https://www.tga.gov.au/resources/artg/81458", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "status": "withheld_repackaged_or_non_exact_visual", "title": { "zh": "已核验四项 TGA 产品级记录与官方电子说明书，但未保留可与单一强度、单一包装一一对应的官方包装图，故不展示包装图片", "en": "Four TGA product-level records and official electronic leaflets were reviewed, but no official package image matching one exact strength and pack was retained, so no package visual is shown" }, "summary": { "zh": "本档案保留 TGA ARTG 中 ARCOXIA、依托考昔 30／60／90／120 mg 片、四个 ARTG 编号、泡罩包装、当前 sponsor 及 PI/CMI 入口。此次没有保留可与单一强度和单一泡罩包装逐一对应的官方原品牌图片；为避免把零售图、版本不明图、其他市场图或另一种依托考昔/NSAID 产品误作准确 ARCOXIA 包装，页面不展示包装图片，只保留官方文字身份和电子说明书供放大阅读。", "en": "This dossier retains ARCOXIA, etoricoxib 30/60/90/120 mg tablets, four ARTG numbers, blister packaging, the current sponsor and PI/CMI routes from TGA ARTG records. No official original-brand image was retained that can be matched one-to-one to a single strength and blister pack; to avoid treating a retail image, version-uncertain image, another-market image or another etoricoxib/NSAID product as the exact ARCOXIA pack, the page withholds package imagery and retains official text identity and electronic leaflets for enlarged reading." }, "source": { "id": "src_ec52afb15f35a6bd", "label": "澳大利亚 TGA：ARCOXIA 依托考昔 30 mg 片泡罩包装（ARTG 131797；四项档案入口之一）", "url": "https://www.tga.gov.au/resources/artg/131797", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "ARCOXIA 说明书放大阅读：30、60、90、120 mg 是四种准确片剂身份", "en": "ARCOXIA label reading: 30, 60, 90 and 120 mg identify four exact tablet presentations" }, "summary": { "zh": "本模块以四项 TGA ARTG 记录及其官方 PI/CMI 入口为边界，帮助核对 ARCOXIA、依托考昔、每片标示量、口服片、泡罩包装与 ARTG 编号。它不提供个人片数、频率、疗程、漏用处理、开始、停用、联用、换药或购买方案。", "en": "This module is bounded by four TGA ARTG records and their official PI/CMI routes. It helps check ARCOXIA, etoricoxib, the labelled amount per tablet, oral-tablet form, blister packaging and ARTG number. It provides no individual tablet count, frequency, course, missed-use action, start, stop, co-use, switch or purchase plan." }, "checks": [ { "zh": "先把 ARCOXIA、依托考昔、每片 30／60／90／120 mg、口服片、泡罩包装、ARTG 编号和目标市场作为一组核对。四个数字分别识别不同的准确片剂，不是从网页推算个人片数、把多片拼成另一强度或自行换药的公式。", "en": "Check ARCOXIA, etoricoxib, 30/60/90/120 mg per tablet, oral-tablet form, blister pack, ARTG number and target market together. The four numbers identify different exact tablets; they are not a web formula for an individual's tablet count, assembling another strength from several tablets or self-switching." }, { "zh": "依托考昔属于 NSAID/选择性 COX-2 抑制剂类别。类别文字首先是核对重复和风险的线索，不表示可以与 ADVIL、ALEVE、MOBIC、CELEBREX、阿司匹林、感冒止痛药或另一依托考昔产品自行叠加、错开、轮换或按 mg 换算。请将所有处方药、非处方药、草本和补充剂连同实际药盒交给药师或开方团队核对。", "en": "Etoricoxib is in the NSAID/selective COX-2 inhibitor class. Class wording is first a cue to check duplication and risk; it does not permit self-combining, separating, alternating or milligram-converting it with ADVIL, ALEVE, MOBIC, CELEBREX, aspirin, cold/pain products or another etoricoxib product. Have a pharmacist or prescriber review every prescription, OTC product, herb and supplement together with the actual packs." }, { "zh": "30、60、120 mg 的 TGA 页面链接一项有效至 2026-11-10 的 Section 14 consent，涉及包装上 sponsor 旧联系信息。本页不会把这一行政合规记录误写成产品失效、假药或疗效变化；若实际包装联系信息与当前记录不一致，请使用 TGA 当前 ARTG、PI/CMI 或当前 sponsor 渠道核实。", "en": "The TGA pages for 30, 60 and 120 mg link a Section 14 consent effective until 10 November 2026 concerning former sponsor contact details on packaging. This administrative compliance record is not presented here as product failure, falsification or changed efficacy. If contact details on the actual pack differ from the current record, verify through the current TGA ARTG, PI/CMI or sponsor route." }, { "zh": "出现急性、严重或迅速进展的不适时，应优先使用当地紧急医疗渠道；不要等待网页检索，也不要依据本页自行加药、停药、换药或用另一盒止痛药抵消。", "en": "With an acute, serious or rapidly worsening concern, use local urgent medical pathways first; do not wait for a web search or self-add, stop, switch or counteract with another pain medicine based on this page." } ], "source": { "id": "src_ec52afb15f35a6bd", "label": "澳大利亚 TGA：ARCOXIA 官方 Product Information / Consumer Medicine Information 入口", "url": "https://www.tga.gov.au/resources/artg/131797", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "依托考昔怎样起作用：选择性 COX-2 抑制是机制线索，不是个人选择规则", "en": "How etoricoxib works: selective COX-2 inhibition is a mechanism cue, not a personal selection rule" }, "summary": { "zh": "TGA 的公开审议记录将依托考昔描述为非甾体抗炎药（NSAID）和选择性环氧合酶-2（COX-2）抑制剂。该术语只解释一种药理分类与作用路径；它不判断个人疼痛原因、心血管或胃肠风险、是否适用、片数、疗程、联用、停用或替代。", "en": "A TGA public scheduling record describes etoricoxib as a non-steroidal anti-inflammatory drug (NSAID) and selective cyclo-oxygenase-2 (COX-2) inhibitor. This wording explains a pharmacologic class and pathway only; it does not determine an individual's pain cause, cardiovascular or gastrointestinal risk, suitability, tablet count, course, co-use, stopping or replacement." }, "checks": [ { "zh": "“选择性 COX-2”不是“对所有人更安全”或“可以与其他 NSAID 同服”的同义词。专业评估仍需结合实际产品、当前说明书、既往反应、心血管/胃肠/肾脏相关情况和完整药单。", "en": "“Selective COX-2” is not synonymous with “safer for everyone” or permission to combine with another NSAID. Professional review still requires the actual product, current leaflet, prior reactions, cardiovascular/gastrointestinal/kidney context and complete medicine list." }, { "zh": "共同类别、共同用途或相近 mg 数字不能证明 ARCOXIA 与 CELEBREX、MOBIC、ADVIL、ALEVE 或另一依托考昔产品等效、可自行替代或可以叠加。剂型、强度、市场、标签版本和其他成分都要逐项核对。", "en": "A shared class, purpose or nearby milligram number does not establish that ARCOXIA is equivalent to, self-substitutable for or combinable with CELEBREX, MOBIC, ADVIL, ALEVE or another etoricoxib product. Dosage form, strength, market, label version and other ingredients all require item-by-item review." }, { "zh": "机制说明不能替代药物警戒、相互作用或症状评估。若新增处方、非处方止痛/感冒药、抗凝药、草本或补充剂，或出现新的严重不适，请带准确药盒和完整药单联系药师或医疗团队；急性严重情况优先使用当地紧急医疗渠道。", "en": "A mechanism explanation does not replace pharmacovigilance, interaction review or symptom assessment. When a prescription, OTC pain/cold medicine, anticoagulant, herb or supplement is added, or a new serious concern occurs, take the exact pack and full medicine list to a pharmacist or care team; use local urgent-care channels first for an acute serious concern." } ], "source": { "id": "src_e92c0e02a7bea8a6", "label": "澳大利亚 TGA：依托考昔列入处方药类别的公开审议记录（2003；历史监管文件）", "url": "https://www.tga.gov.au/sites/default/files/ndpsc-record-37.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "regulatory_decision_record", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "ARCOXIA", "generic": "依托考昔", "dosageFormClass": "依托考昔 30 mg、60 mg、90 mg、120 mg 薄膜衣口服片；TGA ARTG 所列泡罩包装" }, "labelSource": { "id": "src_ec52afb15f35a6bd", "label": "澳大利亚 TGA：ARCOXIA 依托考昔 30 mg 片泡罩包装（ARTG 131797）", "url": "https://www.tga.gov.au/resources/artg/131797", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" }, "productRoutes": [ { "source": { "id": "src_ec52afb15f35a6bd", "label": "澳大利亚 TGA：ARCOXIA 依托考昔 30 mg 片泡罩包装（ARTG 131797）", "url": "https://www.tga.gov.au/resources/artg/131797", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" }, "status": "product_level_public_record_verified", "authority": { "zh": "TGA", "en": "TGA" }, "market": { "zh": "澳大利亚", "en": "Australia" }, "recordType": { "zh": "监管产品记录或公开说明书", "en": "Regulatory product record or public product information" }, "reviewedAt": "2026-08-28", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_0e3e8c55d792ac01", "label": "澳大利亚 TGA：ARCOXIA 依托考昔 60 mg 片泡罩包装（ARTG 81456）", "url": "https://www.tga.gov.au/resources/artg/81456", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" }, "status": "product_level_public_record_verified", "authority": { "zh": "TGA", "en": "TGA" }, "market": { "zh": "澳大利亚", "en": "Australia" }, "recordType": { "zh": "监管产品记录或公开说明书", "en": "Regulatory product record or public product information" }, "reviewedAt": "2026-08-28", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_7c07425503a5cbb9", "label": "澳大利亚 TGA：ARCOXIA 依托考昔 90 mg 片泡罩包装（ARTG 204147）", "url": "https://www.tga.gov.au/resources/artg/204147", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" }, "status": "product_level_public_record_verified", "authority": { "zh": "TGA", "en": "TGA" }, "market": { "zh": "澳大利亚", "en": "Australia" }, "recordType": { "zh": "监管产品记录或公开说明书", "en": "Regulatory product record or public product information" }, "reviewedAt": "2026-08-28", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_103e8f7bd192a28f", "label": "澳大利亚 TGA：ARCOXIA 依托考昔 120 mg 片泡罩包装（ARTG 81458）", "url": "https://www.tga.gov.au/resources/artg/81458", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" }, "status": "product_level_public_record_verified", "authority": { "zh": "TGA", "en": "TGA" }, "market": { "zh": "澳大利亚", "en": "Australia" }, "recordType": { "zh": "监管产品记录或公开说明书", "en": "Regulatory product record or public product information" }, "reviewedAt": "2026-08-28", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_3924715f5abefd1b", "label": "澳大利亚 TGA eBS：ARCOXIA Product Information（PI）官方入口", "url": "https://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent=&id=CP-2009-PI-00309-3", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_document_with_terms", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" }, "status": "product_level_public_record_verified", "authority": { "zh": "TGA", "en": "TGA" }, "market": { "zh": "澳大利亚", "en": "Australia" }, "recordType": { "zh": "监管产品记录或公开说明书", "en": "Regulatory product record or public product information" }, "reviewedAt": "2026-08-28", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "TGA", "en": "TGA" }, "market": { "zh": "澳大利亚", "en": "Australia" }, "recordType": { "zh": "监管产品记录或公开说明书", "en": "Regulatory product record or public product information" }, "reviewedAt": "2026-08-28", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "这是一份澳大利亚 ARCOXIA 的可追溯产品档案。四项 TGA ARTG 当前公开记录可分别核对依托考昔 30、60、90、120 mg 每片标示量、片剂、泡罩包装、ARTG 编号、当前 sponsor 和官方 PI/CMI 入口。页面帮助先辨认准确产品和来源；不会把四个 mg 数字、NSAID/COX-2 类别或包装文字转换为个人片数、频率、疗程、开始、停用、联用、换药或购买结论。", "history": "TGA ARTG 将 ARCOXIA 60 mg（ARTG 81456）与 120 mg（ARTG 81458）的登记日期列为 2002-10-11，将 30 mg（ARTG 131797）列为 2008-04-11，将 90 mg（ARTG 204147）列为 2013-11-05；四项当前公开记录均列 ORGANON PHARMA PTY LTD。30、60、120 mg 页面另链接一项截至 2026-11-10 的 Section 14 consent，内容针对包装上的 sponsor 旧联系信息；本页只把它作为包装联系信息的合规线索，不把它扩写为疗效、成分、真伪或产品质量结论。", "sourceDocuments": [ { "id": "src_ec52afb15f35a6bd", "label": "澳大利亚 TGA：ARCOXIA 依托考昔 30 mg 片泡罩包装（ARTG 131797）", "url": "https://www.tga.gov.au/resources/artg/131797", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" }, { "id": "src_0e3e8c55d792ac01", "label": "澳大利亚 TGA：ARCOXIA 依托考昔 60 mg 片泡罩包装（ARTG 81456）", "url": "https://www.tga.gov.au/resources/artg/81456", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" }, { "id": "src_7c07425503a5cbb9", "label": "澳大利亚 TGA：ARCOXIA 依托考昔 90 mg 片泡罩包装（ARTG 204147）", "url": "https://www.tga.gov.au/resources/artg/204147", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" }, { "id": "src_103e8f7bd192a28f", "label": "澳大利亚 TGA：ARCOXIA 依托考昔 120 mg 片泡罩包装（ARTG 81458）", "url": "https://www.tga.gov.au/resources/artg/81458", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" }, { "id": "src_3924715f5abefd1b", "label": "澳大利亚 TGA eBS：ARCOXIA Product Information（PI）官方入口", "url": "https://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent=&id=CP-2009-PI-00309-3", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_document_with_terms", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" }, { "id": "src_81fbb06bcb263647", "label": "澳大利亚 TGA eBS：ARCOXIA Consumer Medicine Information（CMI）官方入口", "url": "https://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent=&id=CP-2009-CMI-00310-3", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "consumer_medicine_information", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_document_with_terms", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" }, { "id": "src_9b6fc3045338f690", "label": "澳大利亚 TGA：ARCOXIA 30 mg Section 14 consent（sponsor 旧联系信息；有效至 2026-11-10）", "url": "https://www.tga.gov.au/resources/section-14-consents/arcoxia-etoricoxib-30mg-tablet-blister-pack-organon-pharma-pty-ltd-con-1408", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_compliance_record", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" }, { "id": "src_e92c0e02a7bea8a6", "label": "澳大利亚 TGA：依托考昔列入处方药类别的公开审议记录（2003；历史监管文件）", "url": "https://www.tga.gov.au/sites/default/files/ndpsc-record-37.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "regulatory_decision_record", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" } ], "applicationNumber": "澳大利亚 TGA ARTG 131797／81456／204147／81458（ARCOXIA etoricoxib 30／60／90／120 mg tablet blister pack）", "approvalTimeline": [ { "date": "2002-10-11", "title": { "zh": "ARCOXIA 60 mg 与 120 mg 的 TGA ARTG 登记日期", "en": "TGA ARTG dates for ARCOXIA 60 mg and 120 mg" }, "detail": { "zh": "TGA 将 ARTG 81456（60 mg）与 ARTG 81458（120 mg）的 ARTG Date 均列为 2002-10-11。该日期只锚定两项澳大利亚监管产品记录，不建立其他强度、市场、供应、个人片数或疗程。", "en": "TGA lists 11 Oct 2002 as the ARTG date for ARTG 81456 (60 mg) and ARTG 81458 (120 mg). The date anchors two Australian regulatory product records only; it does not establish another strength, market, supply, individual tablet count or course." }, "source": { "id": "src_0e3e8c55d792ac01", "label": "澳大利亚 TGA：ARCOXIA 依托考昔 60 mg 片泡罩包装（ARTG 81456）", "url": "https://www.tga.gov.au/resources/artg/81456", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" } }, { "date": "2008-04-11", "title": { "zh": "ARCOXIA 30 mg 的 TGA ARTG 登记日期", "en": "TGA ARTG date for ARCOXIA 30 mg" }, "detail": { "zh": "TGA 将 ARTG 131797 的产品名列为 ARCOXIA etoricoxib 30mg tablet blister pack，ARTG Date 为 2008-04-11。30 mg 是这一准确片剂的每片标示量，不是个人强度选择或片数换算。", "en": "TGA lists ARCOXIA etoricoxib 30mg tablet blister pack as the product name for ARTG 131797 and 11 Apr 2008 as its ARTG date. The 30 mg figure is the labelled amount per exact tablet, not an individual strength selection or tablet-count conversion." }, "source": { "id": "src_ec52afb15f35a6bd", "label": "澳大利亚 TGA：ARCOXIA 依托考昔 30 mg 片泡罩包装（ARTG 131797）", "url": "https://www.tga.gov.au/resources/artg/131797", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" } }, { "date": "2013-11-05", "title": { "zh": "ARCOXIA 90 mg 的 TGA ARTG 登记日期", "en": "TGA ARTG date for ARCOXIA 90 mg" }, "detail": { "zh": "TGA 将 ARTG 204147 的产品名列为 ARCOXIA etoricoxib 90mg tablet blister pack，ARTG Date 为 2013-11-05。该节点只定位这一澳大利亚产品记录，不表示 90 mg 对任何人适用。", "en": "TGA lists ARCOXIA etoricoxib 90mg tablet blister pack as the product name for ARTG 204147 and 5 Nov 2013 as its ARTG date. The node locates this Australian product record only and does not mean 90 mg is suitable for any individual." }, "source": { "id": "src_7c07425503a5cbb9", "label": "澳大利亚 TGA：ARCOXIA 依托考昔 90 mg 片泡罩包装（ARTG 204147）", "url": "https://www.tga.gov.au/resources/artg/204147", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" } }, { "date": "2025-09-15", "title": { "zh": "Section 14 包装联系信息合规记录开始", "en": "Section 14 packaging-contact compliance record commenced" }, "detail": { "zh": "TGA 的 CON-1408 记录说明，部分 ARCOXIA 包装仍标注 sponsor 旧联系信息，相关 consent 有效至 2026-11-10。本页只将其作为包装联系信息的行政合规边界，不据此断言疗效、成分、真伪、产品失效或质量变化。", "en": "TGA CON-1408 states that some ARCOXIA packaging carries former sponsor contact details and that the consent is effective until 10 Nov 2026. This page treats it only as an administrative compliance boundary for packaging contact details and does not infer efficacy, composition, authenticity, product failure or changed quality." }, "source": { "id": "src_9b6fc3045338f690", "label": "澳大利亚 TGA：ARCOXIA 30 mg Section 14 consent（CON-1408）", "url": "https://www.tga.gov.au/resources/section-14-consents/arcoxia-etoricoxib-30mg-tablet-blister-pack-organon-pharma-pty-ltd-con-1408", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_compliance_record", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" } } ], "marketStatus": [ { "market": { "zh": "澳大利亚", "en": "Australia" }, "status": { "zh": "已链接四项当前 TGA ARTG 产品记录与 PI/CMI 官方入口", "en": "Four current TGA ARTG product records and official PI/CMI routes linked" }, "detail": { "zh": "本页分别记录 30、60、90、120 mg 每片标示量、四个 ARTG 编号、片剂与泡罩包装文字身份。它不鉴定真伪，也不建立库存、实际供应、购买、个人片数、频率、疗程、联用、停用、换药或可替代性。", "en": "The dossier separately records 30, 60, 90 and 120 mg labelled per tablet, four ARTG numbers, tablet form and blister-pack text identities. It does not authenticate a product or establish stock, actual supply, purchase, individual tablet count, frequency, course, co-use, stopping, switching or interchangeability." } }, { "market": { "zh": "中国大陆、美国、欧盟、日本及其他市场", "en": "Mainland China, the United States, the EU, Japan and other markets" }, "status": { "zh": "待逐项建立现行市场记录", "en": "Current market record not established" }, "detail": { "zh": "不从澳大利亚 ARTG 名称、登记日期、sponsor、PI/CMI、COX-2 类别或泡罩包装推定当地商品名、批准、包装、供应、可售资格、原研/仿制关系或可替代性；每个市场须按当地现行监管资料逐产品核对。", "en": "No local trade name, approval, packaging, supply, sale eligibility, originator/generic relationship or interchangeability is inferred from the Australian ARTG name, date, sponsor, PI/CMI, COX-2 class or blister packaging; every market requires exact-product review against current local regulatory material." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "30、60、90、120 mg 能否自己换算片数或互相替代？", "en": "Can 30, 60, 90 and 120 mg be converted into tablet counts or substituted for one another?" }, "answer": { "zh": "不能。它们分别是四种准确片剂的每片标示量。网页不生成个人强度、片数、频率、疗程、漏用补量或换药规则；请以实际处方、准确药盒、当前目标市场说明书和药师/开方团队核对为准。", "en": "No. They are labelled amounts per tablet for four exact presentations. The website does not generate an individual's strength, tablet count, frequency, course, missed-use make-up or switching rule; use the actual prescription, exact pack, current target-market leaflet and pharmacist/prescriber review." } }, { "question": { "zh": "包装上的 sponsor 联系信息与网页不同，是否说明是假药或药品有质量问题？", "en": "If sponsor contact details on the pack differ from this page, does that mean the medicine is falsified or defective?" }, "answer": { "zh": "不能这样判断。TGA 当前 Section 14 记录明确涉及部分包装的旧 sponsor 联系信息，并设置了有效期限；这是一项行政合规记录，不等于对真伪、成分、疗效或质量作结论。请用准确 ARTG 编号、当前 PI/CMI 与 TGA 或 sponsor 当前渠道核实，疑似严重问题应联系当地监管或医疗渠道。", "en": "That conclusion cannot be made. The current TGA Section 14 record concerns former sponsor contact details on some packaging and has a defined period; it is an administrative compliance record, not a finding on authenticity, composition, efficacy or quality. Verify the exact ARTG number, current PI/CMI and current TGA or sponsor route; use local regulatory or medical channels for a serious concern." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "dosage-forms-are-part-of-medicine-identity", "how-to-read-a-drug-label" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/arcoxia/", "en": "https://origindrug.com/en/drugs/arcoxia/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "tenormin", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-23", "status": "published_traceable_archive" }, "names": { "brand": "TENORMIN", "generic": "阿替洛尔", "aliases": [ "TENORMIN", "atenolol", "阿替洛尔", "24979-244-07", "24979-245-07", "24979-246-07" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "心血管", "sourceArchiveMarket": "美国 DailyMed TENORMIN（atenolol）口服片公开标签。本档案仅对应标签展示的 25 mg、50 mg、100 mg 三个 90 片瓶装与对应 NDC；不推定中国大陆或其他市场的当前批准、持有人、供应、可得性或个人适用性。", "dosageFormClass": "口服片：25 mg、50 mg、100 mg（DailyMed 美国公开标签所列）", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "美国公开标签记录（初始批准日期待逐项核验）", "archiveSponsorText": "Upsher-Smith Laboratories, LLC / DailyMed 美国公开标签" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [ "TENORMIN injection", "atenolol injection", "阿替洛尔注射液" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-tenormin-atenolol-tablet-25mg-90-bottle-ndc-2497924407", "marketCode": "US", "labelVersion": { "zh": "DailyMed 美国公开标签（所引页面于 2026-08-23 核验）；仅为标签记录，不代表供应", "en": "U.S. DailyMed public label (access verified 23 Aug 2026); cited label record only, not availability" }, "dosageForm": { "zh": "TENORMIN 阿替洛尔口服片", "en": "TENORMIN atenolol oral tablet" }, "route": { "zh": "口服（标签产品身份字段）", "en": "oral (label product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 24979-244-07", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片阿替洛尔 25 mg；90 片瓶装", "en": "Atenolol 25 mg per tablet; 90-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=tenormin-25mg.jpg&setid=6e850b1e-28a4-4ff8-8ed7-bb0b29faa28a&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "阿替洛尔", "en": "atenolol" }, "value": 25, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、频率、分片或换算指令", "en": "labelled amount per tablet; not an individual's tablet count, frequency, splitting or conversion instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 90, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-23", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 90, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "白色", "en": "white" }, "shape": { "zh": "圆形扁平片；无刻痕", "en": "round, flat tablet; unscored" }, "imprint": "T / 107", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_ec756e687ccd4384", "label": "DailyMed（NLM）：TENORMIN 阿替洛尔美国公开标签（Upsher-Smith；所引页面于 2026-08-23 核验）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=6e850b1e-28a4-4ff8-8ed7-bb0b29faa28a", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-tenormin-atenolol-tablet-50mg-90-bottle-ndc-2497924507", "marketCode": "US", "labelVersion": { "zh": "DailyMed 美国公开标签（所引页面于 2026-08-23 核验）；仅为标签记录，不代表供应", "en": "U.S. DailyMed public label (access verified 23 Aug 2026); cited label record only, not availability" }, "dosageForm": { "zh": "TENORMIN 阿替洛尔口服片", "en": "TENORMIN atenolol oral tablet" }, "route": { "zh": "口服（标签产品身份字段）", "en": "oral (label product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 24979-245-07", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片阿替洛尔 50 mg；90 片瓶装", "en": "Atenolol 50 mg per tablet; 90-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=tenormin-50mg.jpg&setid=6e850b1e-28a4-4ff8-8ed7-bb0b29faa28a&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "阿替洛尔", "en": "atenolol" }, "value": 50, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、频率、分片或换算指令", "en": "labelled amount per tablet; not an individual's tablet count, frequency, splitting or conversion instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 90, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-23", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 90, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "白色", "en": "white" }, "shape": { "zh": "圆形扁平片；双刻痕仅为外观线索，不是分片指令", "en": "round, flat tablet; score is an appearance clue, not a splitting instruction" }, "imprint": "TENORMIN / 105", "scoreStatus": "scored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_ec756e687ccd4384", "label": "DailyMed（NLM）：TENORMIN 阿替洛尔美国公开标签（Upsher-Smith；所引页面于 2026-08-23 核验）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=6e850b1e-28a4-4ff8-8ed7-bb0b29faa28a", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-tenormin-atenolol-tablet-100mg-90-bottle-ndc-2497924607", "marketCode": "US", "labelVersion": { "zh": "DailyMed 美国公开标签（所引页面于 2026-08-23 核验）；仅为标签记录，不代表供应", "en": "U.S. DailyMed public label (access verified 23 Aug 2026); cited label record only, not availability" }, "dosageForm": { "zh": "TENORMIN 阿替洛尔口服片", "en": "TENORMIN atenolol oral tablet" }, "route": { "zh": "口服（标签产品身份字段）", "en": "oral (label product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 24979-246-07", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片阿替洛尔 100 mg；90 片瓶装", "en": "Atenolol 100 mg per tablet; 90-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=tenormin-100mg.jpg&setid=6e850b1e-28a4-4ff8-8ed7-bb0b29faa28a&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "阿替洛尔", "en": "atenolol" }, "value": 100, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、频率、分片或换算指令", "en": "labelled amount per tablet; not an individual's tablet count, frequency, splitting or conversion instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 90, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-23", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 90, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "白色", "en": "white" }, "shape": { "zh": "圆形扁平片；无刻痕", "en": "round, flat tablet; unscored" }, "imprint": "TENORMIN / 101", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_ec756e687ccd4384", "label": "DailyMed（NLM）：TENORMIN 阿替洛尔美国公开标签（Upsher-Smith；所引页面于 2026-08-23 核验）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=6e850b1e-28a4-4ff8-8ed7-bb0b29faa28a", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-tenormin-atenolol-tablet-50mg-90-bottle-ndc-2497924507", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=tenormin-50mg.jpg&setid=6e850b1e-28a4-4ff8-8ed7-bb0b29faa28a&type=img", "alt": "TENORMIN 阿替洛尔美国 DailyMed 公开标签中的 50 mg、NDC 24979-245-07、90 片瓶装展示面", "archiveMarket": "美国", "labelVersion": "DailyMed 美国公开标签（所引页面于 2026-08-23 核验）", "presentation": "TENORMIN 阿替洛尔：每片 50 mg，NDC 24979-245-07，90 片瓶装。", "notice": "此图只对应美国 DailyMed 公开标签中的 TENORMIN、阿替洛尔、每片 50 mg、NDC 24979-245-07 与 90 片瓶装。50 mg 片上的刻痕只作为标签外观线索展示，并不表示可以自行掰开、改变片数或换成另一种规格；此图也不用于鉴定真伪，不证明其他规格、包装、市场、当前可得性、原研身份、可替代性或个人治疗方案。", "source": { "id": "src_ec756e687ccd4384", "label": "DailyMed（NLM）：TENORMIN 阿替洛尔美国公开标签（Upsher-Smith；所引页面于 2026-08-23 核验）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=6e850b1e-28a4-4ff8-8ed7-bb0b29faa28a", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "TENORMIN 说明书放大阅读：25、50、100 mg 是片剂身份，不是“该吃几片”", "en": "TENORMIN label reading: 25, 50 and 100 mg identify tablets; they do not answer “how many tablets”" }, "summary": { "zh": "本模块只阅读 DailyMed 美国公开标签中的 TENORMIN、阿替洛尔、口服片、每片标示量、NDC、包装与重要警示。它不提供个人片数、服用时间、分片、联用、停用、换药或购买方案。", "en": "This module reads only TENORMIN, atenolol, oral tablets, labelled amount per tablet, NDCs, packaging and key warnings in the U.S. DailyMed public label. It provides no individual tablet count, timing, splitting, co-use, stopping, switching or purchase plan." }, "checks": [ { "zh": "先把 TENORMIN、阿替洛尔、口服片、每片 25／50／100 mg、实际 NDC、90 片瓶装和目标市场一起核对。mg 是准确片剂的标示量，不是网页可换算成个人每天应服几片，或把另一个规格、品牌、剂型或 β 受体阻断剂自行互换的规则。", "en": "Check TENORMIN, atenolol, oral-tablet form, the stated 25/50/100 mg per tablet, actual NDC, 90-tablet bottle and target market together. Mg is the labelled amount in an exact tablet, not a web rule for an individual's daily tablet count or for self-exchanging another strength, brand, form or beta blocker." }, { "zh": "50 mg 片在标签外观描述中有双刻痕；这只帮助识别该准确片剂。是否可掰开、如何处理吞咽困难或是否需要另一种规格，必须由实际处方、该产品现行说明书和药师或开方团队确认，不能由刻痕、上一盒药或网页自行决定。", "en": "The label's appearance description shows a bisect score on the 50 mg tablet; that only helps identify this exact tablet. Whether it may be split, how to address swallowing difficulty, or whether another strength is needed must be confirmed from the actual prescription, current label and a pharmacist or prescriber—not from a score, a prior pack or this webpage." }, { "zh": "标签对突然停用、心率/血压、肾功能、呼吸系统疾病、妊娠/哺乳及与其他药物同在清单上时的风险提示，需要由专业人员结合实际情况复核。不要因感觉变化或看见另一种同类药，就自行开始、加减、停用、叠加、隔天轮换或替换。", "en": "The label contains cautions involving sudden discontinuation, heart rate/blood pressure, kidney function, respiratory disease, pregnancy/breastfeeding and the presence of other medicines on the list. These need professional review in the actual context. Do not self-start, adjust, stop, combine, alternate or replace it because of a feeling or another same-class pack." }, { "zh": "出现晕厥、呼吸困难、明显心悸/心率异常、胸痛、严重过敏或其他急性严重不适时，应优先使用当地紧急医疗服务；不要等待网页检索，也不要用另一盒药自行抵消或试探。", "en": "With fainting, breathing difficulty, marked palpitations/abnormal heart rate, chest pain, a severe allergic reaction or another acute serious concern, prioritise local emergency medical care. Do not wait for a web search or self-counteract or test with another pack." } ], "source": { "id": "src_ec756e687ccd4384", "label": "DailyMed（NLM）：TENORMIN 阿替洛尔美国公开标签（Upsher-Smith；口服片身份、警示与产品说明）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=6e850b1e-28a4-4ff8-8ed7-bb0b29faa28a", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "阿替洛尔怎样起作用：标签所述 β1 受体阻断路径", "en": "How atenolol works: the beta-1 receptor-blocking pathway described in the label" }, "summary": { "zh": "美国公开标签将 TENORMIN 描述为偏向 β1 的 β 受体阻断剂，并明确这种选择性不是绝对的。这个机制帮助理解药物类别和标签警示；它不判断个人心率、血压、呼吸状态、肾功能、适用性、片数或任何联用方案。", "en": "The U.S. public label describes TENORMIN as a preferential beta-1 selective beta blocker and explicitly notes that this selectivity is not absolute. This mechanism helps read drug class and label cautions; it does not determine an individual's heart rate, blood pressure, breathing status, kidney function, suitability, tablet count or any combination plan." }, "checks": [ { "zh": "“β1 选择性”或“β 受体阻断剂”是机制和类别线索，不代表与其他 β 受体阻断剂可以自行叠加、轮换、替代或按 mg 换算。准确产品、强度、剂型、目标市场标签、既往反应和完整药单都需一起核对。", "en": "“Beta-1 selective” and “beta blocker” are mechanism and class clues; they do not permit self-combining, alternating, substituting or milligram-converting with another beta blocker. The exact product, strength, dosage form, target-market label, prior reactions and complete medicine list all need review together." }, { "zh": "看到药物机制或某项标签适应症，不能从网页判断某个人是否适合该药或是否应改变用药。涉及心率、血压、呼吸症状、肾功能或新增药物时，请由能看到完整病史、检查和药单的专业人员核对。", "en": "A mechanism or a labelled indication cannot let a webpage decide whether a person is suitable for this medicine or should change use. For heart rate, blood pressure, breathing symptoms, kidney function or an added medicine, obtain review from a professional who can see the complete history, tests and medicine list." }, { "zh": "机制解释不能替代药物警戒、相互作用核对或紧急评估。急性严重不适请优先使用当地紧急医疗渠道；其他问题请带实际药盒和完整药单联系药师或开方团队。", "en": "Mechanism information does not replace pharmacovigilance, interaction review or emergency assessment. For an acute serious problem, prioritise local emergency care; for other questions, contact a pharmacist or prescribing team with the actual pack and complete medicine list." } ], "source": { "id": "src_ec756e687ccd4384", "label": "DailyMed（NLM）：TENORMIN 阿替洛尔美国公开标签（Upsher-Smith；Clinical Pharmacology）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=6e850b1e-28a4-4ff8-8ed7-bb0b29faa28a", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "TENORMIN", "generic": "阿替洛尔", "dosageFormClass": "口服片：25 mg、50 mg、100 mg（DailyMed 美国公开标签所列）" }, "labelSource": { "id": "src_ec756e687ccd4384", "label": "DailyMed（NLM）：TENORMIN 阿替洛尔美国公开标签（Upsher-Smith；所引页面于 2026-08-23 核验）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=6e850b1e-28a4-4ff8-8ed7-bb0b29faa28a", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "productRoutes": [ { "source": { "id": "src_ec756e687ccd4384", "label": "DailyMed（NLM）：TENORMIN 阿替洛尔美国公开标签（Upsher-Smith；所引页面于 2026-08-23 核验）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=6e850b1e-28a4-4ff8-8ed7-bb0b29faa28a", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-23", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-23", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "DailyMed 美国公开标签列示 TENORMIN（atenolol）为口服片，并展示每片 25 mg、50 mg、100 mg、各 90 片瓶装及相应 NDC。本页帮助把商品名、通用名、每片标示量、准确包装面板、现行说明书和药物警戒入口放在一起核对；毫克数只用于产品身份，不能换算为个人片数、频率、分片、联用、换药、停用或购买结论。", "history": "本页只锚定所列美国 DailyMed 公开标签。标签中的产品警示、停用相关文字、心率/血压、肾功能、呼吸系统疾病、妊娠/哺乳和完整用药清单等均需由专业人员结合实际情况阅读；不同剂型、包装、市场或同类产品不能按名称或毫克数自行换算、叠加、轮换或替换。", "sourceDocuments": [ { "id": "src_ec756e687ccd4384", "label": "DailyMed（NLM）：TENORMIN 阿替洛尔美国公开标签（Upsher-Smith；所引页面于 2026-08-23 核验）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=6e850b1e-28a4-4ff8-8ed7-bb0b29faa28a", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" } ], "applicationNumber": "NDA 018240（DailyMed 所引美国公开标签记录）", "approvalTimeline": [ { "date": "2026-08-23", "title": { "zh": "DailyMed 美国公开标签核验", "en": "U.S. DailyMed public-label access verified" }, "detail": { "zh": "本页于 2026-08-23 核验 DailyMed 的 TENORMIN（atenolol）美国公开标签。该记录列示 25 mg、50 mg、100 mg 口服片以及 NDC 24979-244-07、24979-245-07、24979-246-07 的 90 片瓶装展示面；这只用于标签与产品身份核对，不建立实际在售、库存、购买、个人片数、分片、联用、换药或其他市场状态。", "en": "On 23 Aug 2026, this page verified the U.S. DailyMed public label for TENORMIN (atenolol). The record lists 25 mg, 50 mg and 100 mg oral tablets and the 90-tablet bottle panels for NDC 24979-244-07, 24979-245-07 and 24979-246-07; this only supports label and product-identity checking, not actual marketing, stock, purchase, individual tablet count, splitting, co-use, switching or another-market status." }, "source": { "id": "src_ec756e687ccd4384", "label": "DailyMed（NLM）：TENORMIN 阿替洛尔美国公开标签（Upsher-Smith；所引页面于 2026-08-23 核验）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=6e850b1e-28a4-4ff8-8ed7-bb0b29faa28a", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "已链接公开标签与三组准确 90 片瓶装面板", "en": "Public label and three exact 90-tablet bottle panels linked" }, "detail": { "zh": "页面分别展示 TENORMIN 阿替洛尔 25 mg、50 mg、100 mg 的指定 NDC 与 90 片瓶装。50 mg 的刻痕只作外观线索，不建立分片、个人片数、实际在售、库存、购买、真伪或可替代性结论。", "en": "The page separately displays the specified NDC and 90-tablet bottle for TENORMIN atenolol 25 mg, 50 mg and 100 mg. The 50 mg score is only an appearance clue; it does not establish splitting, individual tablet count, actual marketing, stock, purchase, authenticity or interchangeability." } }, { "market": { "zh": "中国大陆、欧盟、日本及其他市场", "en": "Mainland China, EU, Japan and other markets" }, "status": { "zh": "待逐项建立市场记录", "en": "Market record not established" }, "detail": { "zh": "不从美国标签、NDA、NDC、英文品牌、包装图或标签主体推定当地商品名、批准、包装、供应、可售资格、原研/仿制关系或可替代性；每个市场均须按当地现行监管资料单独核对。", "en": "No local trade name, approval, packaging, supply, sale eligibility, originator/generic relationship or interchangeability is inferred from the U.S. label, NDA, NDC, English brand, package image or label entity; every market requires separate checking against current local regulatory material." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "50 mg 片有刻痕，是否就可以自行掰半或用两种规格凑出另一个毫克数？", "en": "The 50 mg tablet has a score. Does that mean I can split it myself or combine strengths to make another milligram number?" }, "answer": { "zh": "不能据此决定。刻痕与 25、50、100 mg 都是该美国标签下准确片剂的身份或外观信息；它们不建立个人片数、分片、补用、换算、同日叠加、隔天轮换或与另一种 β 受体阻断剂替代的规则。请让药师或开方团队按实际药盒、处方和完整药单核对。", "en": "No decision follows from that. The score and the 25, 50 and 100 mg values are identity or appearance information for exact tablets in this U.S. label; they do not establish an individual's tablet count, splitting, make-up use, conversion, same-day combination, alternate-day use or replacement with another beta blocker. Have a pharmacist or prescribing team check the actual pack, prescription and complete medicine list." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "dosage-forms-are-part-of-medicine-identity", "how-to-read-a-drug-label" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/tenormin/", "en": "https://origindrug.com/en/drugs/tenormin/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "inderal-la", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-23", "status": "published_traceable_archive" }, "names": { "brand": "INDERAL LA", "generic": "盐酸普萘洛尔", "aliases": [ "INDERAL LA", "propranolol hydrochloride", "propranolol", "盐酸普萘洛尔", "普萘洛尔", "62559-520-01", "62559-521-01", "62559-522-01", "62559-523-01" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "心血管", "sourceArchiveMarket": "美国 DailyMed INDERAL LA（propranolol hydrochloride）缓释口服胶囊公开标签。本档案仅对应标签展示的 60 mg、80 mg、120 mg、160 mg 四个 100 粒瓶装与对应 NDC；不推定中国大陆或其他市场的当前批准、持有人、供应、可得性或个人适用性。", "dosageFormClass": "缓释口服胶囊：60 mg、80 mg、120 mg、160 mg（DailyMed 美国公开标签所列）", "dosageFormClassCode": "oral_modified_release", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "美国公开标签记录（初始批准日期待逐项核验）", "archiveSponsorText": "ANI Pharmaceuticals, Inc. / DailyMed 美国公开标签" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [ "INDERAL tablet", "INDERAL XL", "INNOPRAN XL", "propranolol injection", "普萘洛尔注射液" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-inderal-la-propranolol-hydrochloride-extended-release-capsule-60mg-100-bottle-ndc-6255952001", "marketCode": "US", "labelVersion": { "zh": "DailyMed 美国公开标签（2024-08-01 更新）；仅为标签记录，不代表供应", "en": "U.S. DailyMed public label (updated 1 Aug 2024); cited label record only, not availability" }, "dosageForm": { "zh": "INDERAL LA 盐酸普萘洛尔缓释口服胶囊", "en": "INDERAL LA propranolol hydrochloride extended-release oral capsule" }, "route": { "zh": "口服（标签产品身份字段）", "en": "oral (label product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 62559-520-01", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_capsule", "primaryDisplay": { "zh": "每粒盐酸普萘洛尔 60 mg；100 粒瓶装", "en": "Propranolol hydrochloride 60 mg per capsule; 100-capsule bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=60mg-label.jpg&setid=35d28979-36b1-4630-b85e-a44e0a443734&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "盐酸普萘洛尔", "en": "propranolol hydrochloride" }, "value": 60, "unit": "mg", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒缓释胶囊标签标示量；不是个人粒数、频率、打开胶囊、联用或换算指令", "en": "labelled amount per extended-release capsule; not an individual's capsule count, frequency, opening, co-use or conversion instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-23", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "physicalClues": { "color": { "zh": "白色／浅蓝色", "en": "white/light blue" }, "shape": { "zh": "缓释胶囊；外观仅用于核对准确标签产品", "en": "extended-release capsule; appearance only helps check the exact labelled product" }, "imprint": "INDERAL LA / 60", "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_0a4aa1678869a30b", "label": "DailyMed（NLM）：INDERAL LA 盐酸普萘洛尔缓释口服胶囊美国公开标签（ANI；2024-08-01 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=35d28979-36b1-4630-b85e-a44e0a443734", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-inderal-la-propranolol-hydrochloride-extended-release-capsule-80mg-100-bottle-ndc-6255952101", "marketCode": "US", "labelVersion": { "zh": "DailyMed 美国公开标签（2024-08-01 更新）；仅为标签记录，不代表供应", "en": "U.S. DailyMed public label (updated 1 Aug 2024); cited label record only, not availability" }, "dosageForm": { "zh": "INDERAL LA 盐酸普萘洛尔缓释口服胶囊", "en": "INDERAL LA propranolol hydrochloride extended-release oral capsule" }, "route": { "zh": "口服（标签产品身份字段）", "en": "oral (label product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 62559-521-01", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_capsule", "primaryDisplay": { "zh": "每粒盐酸普萘洛尔 80 mg；100 粒瓶装", "en": "Propranolol hydrochloride 80 mg per capsule; 100-capsule bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=80mg-label.jpg&setid=35d28979-36b1-4630-b85e-a44e0a443734&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "盐酸普萘洛尔", "en": "propranolol hydrochloride" }, "value": 80, "unit": "mg", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒缓释胶囊标签标示量；不是个人粒数、频率、打开胶囊、联用或换算指令", "en": "labelled amount per extended-release capsule; not an individual's capsule count, frequency, opening, co-use or conversion instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-23", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "physicalClues": { "color": { "zh": "浅蓝色", "en": "light blue" }, "shape": { "zh": "缓释胶囊；外观仅用于核对准确标签产品", "en": "extended-release capsule; appearance only helps check the exact labelled product" }, "imprint": "INDERAL LA / 80", "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_0a4aa1678869a30b", "label": "DailyMed（NLM）：INDERAL LA 盐酸普萘洛尔缓释口服胶囊美国公开标签（ANI；2024-08-01 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=35d28979-36b1-4630-b85e-a44e0a443734", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-inderal-la-propranolol-hydrochloride-extended-release-capsule-120mg-100-bottle-ndc-6255952201", "marketCode": "US", "labelVersion": { "zh": "DailyMed 美国公开标签（2024-08-01 更新）；仅为标签记录，不代表供应", "en": "U.S. DailyMed public label (updated 1 Aug 2024); cited label record only, not availability" }, "dosageForm": { "zh": "INDERAL LA 盐酸普萘洛尔缓释口服胶囊", "en": "INDERAL LA propranolol hydrochloride extended-release oral capsule" }, "route": { "zh": "口服（标签产品身份字段）", "en": "oral (label product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 62559-522-01", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_capsule", "primaryDisplay": { "zh": "每粒盐酸普萘洛尔 120 mg；100 粒瓶装", "en": "Propranolol hydrochloride 120 mg per capsule; 100-capsule bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=120mg-label.jpg&setid=35d28979-36b1-4630-b85e-a44e0a443734&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "盐酸普萘洛尔", "en": "propranolol hydrochloride" }, "value": 120, "unit": "mg", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒缓释胶囊标签标示量；不是个人粒数、频率、打开胶囊、联用或换算指令", "en": "labelled amount per extended-release capsule; not an individual's capsule count, frequency, opening, co-use or conversion instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-23", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "physicalClues": { "color": { "zh": "浅蓝色／深蓝色", "en": "light blue/dark blue" }, "shape": { "zh": "缓释胶囊；外观仅用于核对准确标签产品", "en": "extended-release capsule; appearance only helps check the exact labelled product" }, "imprint": "INDERAL LA / 120", "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_0a4aa1678869a30b", "label": "DailyMed（NLM）：INDERAL LA 盐酸普萘洛尔缓释口服胶囊美国公开标签（ANI；2024-08-01 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=35d28979-36b1-4630-b85e-a44e0a443734", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-inderal-la-propranolol-hydrochloride-extended-release-capsule-160mg-100-bottle-ndc-6255952301", "marketCode": "US", "labelVersion": { "zh": "DailyMed 美国公开标签（2024-08-01 更新）；仅为标签记录，不代表供应", "en": "U.S. DailyMed public label (updated 1 Aug 2024); cited label record only, not availability" }, "dosageForm": { "zh": "INDERAL LA 盐酸普萘洛尔缓释口服胶囊", "en": "INDERAL LA propranolol hydrochloride extended-release oral capsule" }, "route": { "zh": "口服（标签产品身份字段）", "en": "oral (label product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 62559-523-01", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_capsule", "primaryDisplay": { "zh": "每粒盐酸普萘洛尔 160 mg；100 粒瓶装", "en": "Propranolol hydrochloride 160 mg per capsule; 100-capsule bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=160mg-label.jpg&setid=35d28979-36b1-4630-b85e-a44e0a443734&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "盐酸普萘洛尔", "en": "propranolol hydrochloride" }, "value": 160, "unit": "mg", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒缓释胶囊标签标示量；不是个人粒数、频率、打开胶囊、联用或换算指令", "en": "labelled amount per extended-release capsule; not an individual's capsule count, frequency, opening, co-use or conversion instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-23", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "physicalClues": { "color": { "zh": "深蓝色", "en": "dark blue" }, "shape": { "zh": "缓释胶囊；外观仅用于核对准确标签产品", "en": "extended-release capsule; appearance only helps check the exact labelled product" }, "imprint": "INDERAL LA / 160", "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_0a4aa1678869a30b", "label": "DailyMed（NLM）：INDERAL LA 盐酸普萘洛尔缓释口服胶囊美国公开标签（ANI；2024-08-01 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=35d28979-36b1-4630-b85e-a44e0a443734", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-inderal-la-propranolol-hydrochloride-extended-release-capsule-80mg-100-bottle-ndc-6255952101", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=80mg-label.jpg&setid=35d28979-36b1-4630-b85e-a44e0a443734&type=img", "alt": "INDERAL LA 盐酸普萘洛尔美国 DailyMed 公开标签中的 80 mg、NDC 62559-521-01、100 粒瓶装展示面", "archiveMarket": "美国", "labelVersion": "DailyMed 美国公开标签（2024-08-01 更新）", "presentation": "INDERAL LA 盐酸普萘洛尔缓释口服胶囊：每粒 80 mg，NDC 62559-521-01，100 粒瓶装。", "notice": "此图只对应美国 DailyMed 公开标签中的 INDERAL LA、盐酸普萘洛尔、缓释口服胶囊、每粒 80 mg、NDC 62559-521-01 与 100 粒瓶装。缓释胶囊和 mg 数只作为准确产品身份线索，并不表示可以自行打开、改变粒数、按普通普萘洛尔片换算或换成另一种 β 受体阻断剂；此图也不用于鉴定真伪，不证明其他规格、包装、市场、当前可得性、原研身份、可替代性或个人治疗方案。", "source": { "id": "src_0a4aa1678869a30b", "label": "DailyMed（NLM）：INDERAL LA 盐酸普萘洛尔缓释口服胶囊美国公开标签（ANI；2024-08-01 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=35d28979-36b1-4630-b85e-a44e0a443734", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "INDERAL LA 说明书放大阅读：缓释胶囊和 mg 是产品身份，不是“怎么换、吃几粒”", "en": "INDERAL LA label reading: extended-release capsules and mg identify a product; they do not answer “how to switch or how many capsules”" }, "summary": { "zh": "本模块只阅读 DailyMed 美国公开标签中的 INDERAL LA、盐酸普萘洛尔、缓释口服胶囊、每粒标示量、NDC、包装与重要警示。它不提供个人粒数、服用时间、打开胶囊、联用、停用、换药或购买方案。", "en": "This module reads only INDERAL LA, propranolol hydrochloride, extended-release oral capsules, labelled amount per capsule, NDCs, packaging and key warnings in the U.S. DailyMed public label. It provides no individual capsule count, timing, capsule opening, co-use, stopping, switching or purchase plan." }, "checks": [ { "zh": "先把 INDERAL LA、盐酸普萘洛尔、缓释口服胶囊、每粒 60／80／120／160 mg、实际 NDC、100 粒瓶装和目标市场一起核对。标签明确说明该缓释产品不能简单按 mg 对 mg 视为普通普萘洛尔的替代；mg 是准确胶囊的标示量，不是网页可换算的个人粒数或换药规则。", "en": "Check INDERAL LA, propranolol hydrochloride, extended-release oral-capsule form, the stated 60/80/120/160 mg per capsule, actual NDC, 100-capsule bottle and target market together. The label expressly says this extended-release product is not a simple mg-for-mg substitute for conventional propranolol; mg is an exact-capsule identity field, not a web conversion or switching rule." }, { "zh": "缓释胶囊的名称、外观和包装只帮助识别准确产品。是否能打开胶囊、如何处理吞咽困难、是否需要另一种剂型或规格，必须由实际处方、该产品现行说明书和药师或开方团队确认，不能由上一盒药、相近 mg 数字或网页自行决定。", "en": "The extended-release capsule name, appearance and package only help identify the exact product. Whether a capsule may be opened, how to address swallowing difficulty, or whether another form or strength is needed must be confirmed from the actual prescription, current label and a pharmacist or prescriber—not from a prior pack, a similar mg number or this webpage." }, { "zh": "标签对突然停用、心脏相关风险、呼吸系统疾病、心力衰竭、甲状腺功能亢进症状掩盖及与其他药物同在清单上时的风险提示，需要由专业人员结合实际情况复核。不要因感觉变化、同名普通片或看见另一种同类药，就自行开始、加减、停用、叠加、隔天轮换或替换。", "en": "The label contains cautions involving abrupt discontinuation, cardiac risks, bronchospastic lung disease, heart failure, masking of hyperthyroid signs and other medicines on the list. These need professional review in the actual context. Do not self-start, adjust, stop, combine, alternate or replace it because of a feeling, a conventional tablet with the same generic name or another same-class pack." }, { "zh": "出现晕厥、呼吸困难、明显心悸/心率异常、胸痛、严重过敏或其他急性严重不适时，应优先使用当地紧急医疗服务；不要等待网页检索，也不要用另一盒药自行抵消或试探。", "en": "With fainting, breathing difficulty, marked palpitations/abnormal heart rate, chest pain, a severe allergic reaction or another acute serious concern, prioritise local emergency medical care. Do not wait for a web search or self-counteract or test with another pack." } ], "source": { "id": "src_0a4aa1678869a30b", "label": "DailyMed（NLM）：INDERAL LA 盐酸普萘洛尔缓释口服胶囊美国公开标签（ANI；缓释胶囊身份、警示与产品说明）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=35d28979-36b1-4630-b85e-a44e0a443734", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "普萘洛尔怎样起作用：标签所述非选择性 β 受体阻断路径", "en": "How propranolol works: the nonselective beta-receptor blocking pathway described in the label" }, "summary": { "zh": "美国公开标签将普萘洛尔描述为非选择性 β 受体阻断剂，并说明其与 β 受体刺激剂竞争可用受体位点。这个机制帮助阅读药物类别和标签警示；它不判断个人心率、血压、呼吸状态、适用性、粒数、打开胶囊或任何联用方案。", "en": "The U.S. public label describes propranolol as a nonselective beta-adrenergic receptor-blocking agent that competes with beta-receptor stimulating agents for available receptor sites. This mechanism helps read drug class and label cautions; it does not determine an individual's heart rate, blood pressure, breathing status, suitability, capsule count, capsule opening or any combination plan." }, "checks": [ { "zh": "“非选择性 β 受体阻断剂”是机制和类别线索，不代表与普通普萘洛尔片、另一种缓释产品或其他 β 受体阻断剂可以自行叠加、轮换、替代或按 mg 换算。准确产品、强度、释放方式、目标市场标签、既往反应和完整药单都需一起核对。", "en": "“Nonselective beta blocker” is a mechanism and class clue; it does not permit self-combining, alternating, substituting or milligram-converting with a conventional propranolol tablet, another extended-release product or another beta blocker. The exact product, strength, release design, target-market label, prior reactions and complete medicine list all need review together." }, { "zh": "看到药物机制或某项标签适应症，不能从网页判断某个人是否适合该药或是否应改变用药。涉及心率、血压、呼吸症状、停用、吞咽或新增药物时，请由能看到完整病史、检查和药单的专业人员核对。", "en": "A mechanism or a labelled indication cannot let a webpage decide whether a person is suitable for this medicine or should change use. For heart rate, blood pressure, breathing symptoms, stopping, swallowing or an added medicine, obtain review from a professional who can see the complete history, tests and medicine list." }, { "zh": "机制解释不能替代药物警戒、相互作用核对或紧急评估。急性严重不适请优先使用当地紧急医疗渠道；其他问题请带实际药盒和完整药单联系药师或开方团队。", "en": "Mechanism information does not replace pharmacovigilance, interaction review or emergency assessment. For an acute serious problem, prioritise local emergency care; for other questions, contact a pharmacist or prescribing team with the actual pack and complete medicine list." } ], "source": { "id": "src_0a4aa1678869a30b", "label": "DailyMed（NLM）：INDERAL LA 盐酸普萘洛尔缓释口服胶囊美国公开标签（ANI；Clinical Pharmacology）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=35d28979-36b1-4630-b85e-a44e0a443734", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "INDERAL LA", "generic": "盐酸普萘洛尔", "dosageFormClass": "缓释口服胶囊：60 mg、80 mg、120 mg、160 mg（DailyMed 美国公开标签所列）" }, "labelSource": { "id": "src_0a4aa1678869a30b", "label": "DailyMed（NLM）：INDERAL LA 盐酸普萘洛尔缓释口服胶囊美国公开标签（ANI；2024-08-01 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=35d28979-36b1-4630-b85e-a44e0a443734", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "productRoutes": [ { "source": { "id": "src_0a4aa1678869a30b", "label": "DailyMed（NLM）：INDERAL LA 盐酸普萘洛尔缓释口服胶囊美国公开标签（ANI；2024-08-01 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=35d28979-36b1-4630-b85e-a44e0a443734", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-23", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-23", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "DailyMed 美国公开标签列示 INDERAL LA（propranolol hydrochloride）为缓释口服胶囊，并展示每粒 60 mg、80 mg、120 mg、160 mg、各 100 粒瓶装及相应 NDC。本页帮助把商品名、通用名、缓释剂型、每粒标示量、准确包装面板、说明书和药物警戒入口放在一起核对；毫克数只用于产品身份，不能换算为个人粒数、频率、打开胶囊、联用、换药、停用或购买结论。", "history": "本页只锚定所列美国 DailyMed 公开标签。标签明确指出 INDERAL LA 不应被视为普通普萘洛尔的简单 mg 对 mg 替代；同一通用名、相近 mg 数字或其他 β 受体阻断剂均不能据此自行换算、叠加、轮换或替换。涉及开始、调整、停用、吞咽或打开胶囊、呼吸系统疾病、心率/血压或完整用药清单时，应由药师或开方团队结合实际处方和现行标签核对。", "sourceDocuments": [ { "id": "src_0a4aa1678869a30b", "label": "DailyMed（NLM）：INDERAL LA 盐酸普萘洛尔缓释口服胶囊美国公开标签（ANI；2024-08-01 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=35d28979-36b1-4630-b85e-a44e0a443734", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" } ], "applicationNumber": "DailyMed SPL setid 35d28979-36b1-4630-b85e-a44e0a443734（美国公开标签；本档案不据此推定其他市场状态）", "approvalTimeline": [ { "date": "2024-08-01", "title": { "zh": "DailyMed 美国公开标签更新", "en": "U.S. DailyMed public label updated" }, "detail": { "zh": "DailyMed 将 INDERAL LA（盐酸普萘洛尔）缓释口服胶囊美国公开标签的 Updated 日期列为 2024-08-01。本页只用该记录核对 60 mg、80 mg、120 mg、160 mg 四种缓释胶囊及 NDC 62559-520-01、62559-521-01、62559-522-01、62559-523-01 的 100 粒瓶装展示面；这只用于标签与产品身份核对，不建立实际在售、库存、购买、个人粒数、打开胶囊、联用、换药或其他市场状态。", "en": "DailyMed lists 1 Aug 2024 as the Updated date for the U.S. public label for INDERAL LA (propranolol hydrochloride) extended-release oral capsules. This page uses that record only to check 60 mg, 80 mg, 120 mg and 160 mg extended-release capsules and the 100-capsule bottle panels for NDC 62559-520-01, 62559-521-01, 62559-522-01 and 62559-523-01; this only supports label and product-identity checking, not actual marketing, stock, purchase, individual capsule count, capsule opening, co-use, switching or another-market status." }, "source": { "id": "src_0a4aa1678869a30b", "label": "DailyMed（NLM）：INDERAL LA 盐酸普萘洛尔缓释口服胶囊美国公开标签（ANI；2024-08-01 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=35d28979-36b1-4630-b85e-a44e0a443734", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "已链接公开标签与四组准确 100 粒瓶装面板", "en": "Public label and four exact 100-capsule bottle panels linked" }, "detail": { "zh": "页面分别展示 INDERAL LA 盐酸普萘洛尔缓释胶囊 60 mg、80 mg、120 mg、160 mg 的指定 NDC 与 100 粒瓶装。缓释剂型与 mg 只作产品身份线索，不建立个人粒数、打开胶囊、实际在售、库存、购买、真伪或可替代性结论。", "en": "The page separately displays the specified NDC and 100-capsule bottle for INDERAL LA propranolol hydrochloride extended-release capsules 60 mg, 80 mg, 120 mg and 160 mg. Release design and mg are only product-identity clues; they do not establish individual capsule count, capsule opening, actual marketing, stock, purchase, authenticity or interchangeability." } }, { "market": { "zh": "中国大陆、欧盟、日本及其他市场", "en": "Mainland China, EU, Japan and other markets" }, "status": { "zh": "待逐项建立市场记录", "en": "Market record not established" }, "detail": { "zh": "不从美国标签、SPL、NDC、英文品牌、包装图或标签主体推定当地商品名、批准、包装、供应、可售资格、原研/仿制关系或可替代性；每个市场均须按当地现行监管资料单独核对。", "en": "No local trade name, approval, packaging, supply, sale eligibility, originator/generic relationship or interchangeability is inferred from the U.S. label, SPL, NDC, English brand, package image or label holder; every market requires separate checking against current local regulatory material." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "同为普萘洛尔，INDERAL LA 缓释胶囊能否按相同 mg 换成普通片，或和另一种 β 受体阻断剂自行轮换？", "en": "With the same generic name propranolol, can INDERAL LA extended-release capsules be self-switched to conventional tablets by the same mg, or alternated with another beta blocker?" }, "answer": { "zh": "不能。标签明确说明 INDERAL LA 不应视为普通普萘洛尔的简单 mg 对 mg 替代。释放方式、准确胶囊、强度、包装、标签版本、市场和处方都是产品身份的一部分；请让药师或开方团队按实际药盒和完整药单核对。", "en": "No. The label expressly says INDERAL LA should not be considered a simple mg-for-mg substitute for conventional propranolol. Release design, exact capsule, strength, package, label version, market and prescription are all part of product identity; have a pharmacist or prescriber check the actual packs and complete medicine list." } }, { "question": { "zh": "胶囊写 60、80、120 或 160 mg，是否表示我能自行打开、减少粒数或调整？", "en": "Do 60, 80, 120 or 160 mg on the capsule mean I can open it, reduce capsules or adjust it myself?" }, "answer": { "zh": "不是。它们只是此美国标签下准确缓释胶囊的每粒标示量。页面不提供打开胶囊、个人粒数、服用时间、漏用处理、加倍、停用或替换指令；请按实际处方、准确产品现行标签和药师或开方团队的核对处理。", "en": "No. They are only labelled amounts per exact extended-release capsule in this U.S. label. This page provides no capsule-opening, individual capsule-count, timing, missed-use, doubling, stopping or substitution instruction; follow the actual prescription, current label for the exact product, and pharmacist or prescriber review." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "dosage-forms-are-part-of-medicine-identity", "how-to-read-a-drug-label" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/inderal-la/", "en": "https://origindrug.com/en/drugs/inderal-la/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "lyrica", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-21", "status": "published_traceable_archive" }, "names": { "brand": "Lyrica", "generic": "普瑞巴林", "aliases": [ "pregabalin", "乐瑞卡" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "神经与认知", "sourceArchiveMarket": "美国当前公开处方药标签（DailyMed SPL v18，2025-09-29 发布；不代表供应）", "dosageFormClass": "口服胶囊 25/50/75/100/150/200/225/300 mg；口服溶液 20 mg/mL（本档案所列）", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "2004（DailyMed 当前美国公开标签所列美国初始批准）", "archiveSponsorText": "Viatris Specialty LLC（当前美国公开标签所列）" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-lyrica-pregabalin-25mg-90-capsule-bottle-ndc-58151-236-77", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v18；2025-04-15 生效，2025-09-29 发布", "en": "DailyMed SPL v18; effective 15 Apr 2025 and published 29 Sep 2025" }, "dosageForm": { "zh": "LYRICA 普瑞巴林硬胶囊", "en": "LYRICA pregabalin hard capsule" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 58151-236-77", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_capsule", "primaryDisplay": { "zh": "每粒普瑞巴林 25 mg；90 粒瓶装", "en": "Pregabalin 25 mg per capsule; 90-capsule bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=d4734e7d-5079-455e-8ff5-8f4539c998a9&name=image-15.jpg", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "普瑞巴林", "en": "pregabalin" }, "value": 25, "unit": "mg", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒标签量；不是个人粒数、加减量、换算或换药规则", "en": "labelled amount per capsule; not an individual's capsule count, adjustment, conversion or switching rule" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 90, "countUnit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-21", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 90, "unit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_07b35cf8775d64e4", "label": "DailyMed（NLM）：LYRICA 普瑞巴林当前美国公开标签（Viatris；SPL v18）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=d4734e7d-5079-455e-8ff5-8f4539c998a9&version=18", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-lyrica-pregabalin-50mg-90-capsule-bottle-ndc-58151-237-77", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v18；2025-04-15 生效，2025-09-29 发布", "en": "DailyMed SPL v18; effective 15 Apr 2025 and published 29 Sep 2025" }, "dosageForm": { "zh": "LYRICA 普瑞巴林硬胶囊", "en": "LYRICA pregabalin hard capsule" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 58151-237-77", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_capsule", "primaryDisplay": { "zh": "每粒普瑞巴林 50 mg；90 粒瓶装", "en": "Pregabalin 50 mg per capsule; 90-capsule bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=d4734e7d-5079-455e-8ff5-8f4539c998a9&name=image-16.jpg", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "普瑞巴林", "en": "pregabalin" }, "value": 50, "unit": "mg", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒标签量；不是个人粒数、加减量、换算或换药规则", "en": "labelled amount per capsule; not an individual's capsule count, adjustment, conversion or switching rule" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 90, "countUnit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-21", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 90, "unit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_07b35cf8775d64e4", "label": "DailyMed（NLM）：LYRICA 普瑞巴林当前美国公开标签（Viatris；SPL v18）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=d4734e7d-5079-455e-8ff5-8f4539c998a9&version=18", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-lyrica-pregabalin-75mg-90-capsule-bottle-ndc-58151-238-77", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v18；2025-04-15 生效，2025-09-29 发布", "en": "DailyMed SPL v18; effective 15 Apr 2025 and published 29 Sep 2025" }, "dosageForm": { "zh": "LYRICA 普瑞巴林硬胶囊", "en": "LYRICA pregabalin hard capsule" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 58151-238-77", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_capsule", "primaryDisplay": { "zh": "每粒普瑞巴林 75 mg；90 粒瓶装", "en": "Pregabalin 75 mg per capsule; 90-capsule bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=d4734e7d-5079-455e-8ff5-8f4539c998a9&name=image-17.jpg", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "普瑞巴林", "en": "pregabalin" }, "value": 75, "unit": "mg", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒标签量；不是个人粒数、加减量、换算或换药规则", "en": "labelled amount per capsule; not an individual's capsule count, adjustment, conversion or switching rule" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 90, "countUnit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-21", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 90, "unit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_07b35cf8775d64e4", "label": "DailyMed（NLM）：LYRICA 普瑞巴林当前美国公开标签（Viatris；SPL v18）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=d4734e7d-5079-455e-8ff5-8f4539c998a9&version=18", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-lyrica-pregabalin-100mg-90-capsule-bottle-ndc-58151-239-77", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v18；2025-04-15 生效，2025-09-29 发布", "en": "DailyMed SPL v18; effective 15 Apr 2025 and published 29 Sep 2025" }, "dosageForm": { "zh": "LYRICA 普瑞巴林硬胶囊", "en": "LYRICA pregabalin hard capsule" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 58151-239-77", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_capsule", "primaryDisplay": { "zh": "每粒普瑞巴林 100 mg；90 粒瓶装", "en": "Pregabalin 100 mg per capsule; 90-capsule bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=d4734e7d-5079-455e-8ff5-8f4539c998a9&name=image-18.jpg", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "普瑞巴林", "en": "pregabalin" }, "value": 100, "unit": "mg", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒标签量；不是个人粒数、加减量、换算或换药规则", "en": "labelled amount per capsule; not an individual's capsule count, adjustment, conversion or switching rule" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 90, "countUnit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-21", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 90, "unit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_07b35cf8775d64e4", "label": "DailyMed（NLM）：LYRICA 普瑞巴林当前美国公开标签（Viatris；SPL v18）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=d4734e7d-5079-455e-8ff5-8f4539c998a9&version=18", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-lyrica-pregabalin-150mg-90-capsule-bottle-ndc-58151-240-77", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v18；2025-04-15 生效，2025-09-29 发布", "en": "DailyMed SPL v18; effective 15 Apr 2025 and published 29 Sep 2025" }, "dosageForm": { "zh": "LYRICA 普瑞巴林硬胶囊", "en": "LYRICA pregabalin hard capsule" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 58151-240-77", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_capsule", "primaryDisplay": { "zh": "每粒普瑞巴林 150 mg；90 粒瓶装", "en": "Pregabalin 150 mg per capsule; 90-capsule bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=d4734e7d-5079-455e-8ff5-8f4539c998a9&name=image-19.jpg", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "普瑞巴林", "en": "pregabalin" }, "value": 150, "unit": "mg", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒标签量；不是个人粒数、加减量、换算或换药规则", "en": "labelled amount per capsule; not an individual's capsule count, adjustment, conversion or switching rule" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 90, "countUnit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-21", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 90, "unit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_07b35cf8775d64e4", "label": "DailyMed（NLM）：LYRICA 普瑞巴林当前美国公开标签（Viatris；SPL v18）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=d4734e7d-5079-455e-8ff5-8f4539c998a9&version=18", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-lyrica-pregabalin-200mg-90-capsule-bottle-ndc-58151-241-77", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v18；2025-04-15 生效，2025-09-29 发布", "en": "DailyMed SPL v18; effective 15 Apr 2025 and published 29 Sep 2025" }, "dosageForm": { "zh": "LYRICA 普瑞巴林硬胶囊", "en": "LYRICA pregabalin hard capsule" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 58151-241-77", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_capsule", "primaryDisplay": { "zh": "每粒普瑞巴林 200 mg；90 粒瓶装", "en": "Pregabalin 200 mg per capsule; 90-capsule bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=d4734e7d-5079-455e-8ff5-8f4539c998a9&name=image-20.jpg", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "普瑞巴林", "en": "pregabalin" }, "value": 200, "unit": "mg", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒标签量；不是个人粒数、加减量、换算或换药规则", "en": "labelled amount per capsule; not an individual's capsule count, adjustment, conversion or switching rule" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 90, "countUnit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-21", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 90, "unit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_07b35cf8775d64e4", "label": "DailyMed（NLM）：LYRICA 普瑞巴林当前美国公开标签（Viatris；SPL v18）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=d4734e7d-5079-455e-8ff5-8f4539c998a9&version=18", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-lyrica-pregabalin-225mg-90-capsule-bottle-ndc-58151-243-77", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v18；2025-04-15 生效，2025-09-29 发布", "en": "DailyMed SPL v18; effective 15 Apr 2025 and published 29 Sep 2025" }, "dosageForm": { "zh": "LYRICA 普瑞巴林硬胶囊", "en": "LYRICA pregabalin hard capsule" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 58151-243-77", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_capsule", "primaryDisplay": { "zh": "每粒普瑞巴林 225 mg；90 粒瓶装", "en": "Pregabalin 225 mg per capsule; 90-capsule bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=d4734e7d-5079-455e-8ff5-8f4539c998a9&name=image-21.jpg", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "普瑞巴林", "en": "pregabalin" }, "value": 225, "unit": "mg", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒标签量；不是个人粒数、加减量、换算或换药规则", "en": "labelled amount per capsule; not an individual's capsule count, adjustment, conversion or switching rule" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 90, "countUnit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-21", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 90, "unit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_07b35cf8775d64e4", "label": "DailyMed（NLM）：LYRICA 普瑞巴林当前美国公开标签（Viatris；SPL v18）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=d4734e7d-5079-455e-8ff5-8f4539c998a9&version=18", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-lyrica-pregabalin-300mg-90-capsule-bottle-ndc-58151-242-77", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v18；2025-04-15 生效，2025-09-29 发布", "en": "DailyMed SPL v18; effective 15 Apr 2025 and published 29 Sep 2025" }, "dosageForm": { "zh": "LYRICA 普瑞巴林硬胶囊", "en": "LYRICA pregabalin hard capsule" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 58151-242-77", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_capsule", "primaryDisplay": { "zh": "每粒普瑞巴林 300 mg；90 粒瓶装", "en": "Pregabalin 300 mg per capsule; 90-capsule bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=d4734e7d-5079-455e-8ff5-8f4539c998a9&name=image-22.jpg", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "普瑞巴林", "en": "pregabalin" }, "value": 300, "unit": "mg", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒标签量；不是个人粒数、加减量、换算或换药规则", "en": "labelled amount per capsule; not an individual's capsule count, adjustment, conversion or switching rule" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 90, "countUnit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-21", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 90, "unit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_07b35cf8775d64e4", "label": "DailyMed（NLM）：LYRICA 普瑞巴林当前美国公开标签（Viatris；SPL v18）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=d4734e7d-5079-455e-8ff5-8f4539c998a9&version=18", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-lyrica-pregabalin-20mg-per-ml-473ml-bottle-ndc-58151-244-35", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v18；2025-04-15 生效，2025-09-29 发布", "en": "DailyMed SPL v18; effective 15 Apr 2025 and published 29 Sep 2025" }, "dosageForm": { "zh": "LYRICA 普瑞巴林口服溶液", "en": "LYRICA pregabalin oral solution" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 58151-244-35", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "concentration", "primaryDisplay": { "zh": "普瑞巴林 20 mg/mL；473 mL（16 fl oz）瓶装", "en": "Pregabalin 20 mg/mL; 473 mL (16 fl oz) bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=d4734e7d-5079-455e-8ff5-8f4539c998a9&name=image-23.jpg", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "普瑞巴林", "en": "pregabalin" }, "value": 20, "unit": "mg", "basisCode": "concentration", "basisLabel": { "zh": "每 mL 标签浓度；不是个人 mL 数、换算或调药规则", "en": "labelled concentration per mL; not an individual's millilitre amount, conversion or adjustment rule" } } ], "concentration": { "basisCode": "mg_per_mL", "notation": null, "numerator": { "value": 20, "unit": "mg" }, "denominator": { "value": 1, "unit": "mL" }, "display": { "zh": "20 mg/mL", "en": "20 mg/mL" } }, "container": { "typeCode": "bottle", "typeLabel": { "zh": "白色 HDPE 瓶", "en": "white HDPE bottle" }, "fill": { "value": 473, "unit": "mL" }, "countPerPackage": 1, "countUnit": { "zh": "瓶/盒", "en": "bottle per carton" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-21", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 1, "unit": { "zh": "473 mL 瓶装（16 fl oz）", "en": "473 mL bottle (16 fl oz)" } }, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_07b35cf8775d64e4", "label": "DailyMed（NLM）：LYRICA 普瑞巴林当前美国公开标签（Viatris；SPL v18）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=d4734e7d-5079-455e-8ff5-8f4539c998a9&version=18", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-lyrica-pregabalin-75mg-90-capsule-bottle-ndc-58151-238-77", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=d4734e7d-5079-455e-8ff5-8f4539c998a9&name=image-17.jpg", "alt": "LYRICA 普瑞巴林在美国 DailyMed 当前公开标签中的 75 mg、90 粒、NDC 58151-238-77 瓶装展示面", "archiveMarket": "美国", "labelVersion": "DailyMed SPL v18，2025-09-29 发布", "presentation": "LYRICA 普瑞巴林 75 mg 胶囊，90 粒瓶装，NDC 58151-238-77。", "notice": "此图只对应美国 DailyMed 当前公开标签中的 LYRICA、普瑞巴林 75 mg 胶囊、NDC 58151-238-77 和 90 粒瓶装。它只帮助核对品牌、通用名、每粒标示量、剂型、包装数量和来源；不用于鉴定真伪，也不证明 25/50/100/150/200/225/300 mg 胶囊、20 mg/mL 口服溶液、其他包装、其他市场、当前可得性、原研身份、可替代性或任何个人的粒数、换算、开始、停用或换药方案。", "source": { "id": "src_07b35cf8775d64e4", "label": "DailyMed（NLM）：LYRICA 普瑞巴林当前美国公开标签（Viatris；SPL v18）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=d4734e7d-5079-455e-8ff5-8f4539c998a9&version=18", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "LYRICA 说明书放大阅读：胶囊、口服液与毫克不能只看一个数字", "en": "LYRICA label reading: capsules, oral solution and milligrams are not one number" }, "summary": { "zh": "本模块只帮助阅读 FDA 2025 美国标签中的产品身份与风险线索；不提供普瑞巴林的个人剂量、漏服处理、减量或换药方案。", "en": "This module only helps read product-identity and risk clues in the 2025 U.S. FDA label; it does not provide an individual pregabalin dose, missed-dose, taper or switching plan." }, "checks": [ { "zh": "先核对 LYRICA、普瑞巴林、口服胶囊或口服溶液、标示强度及目标市场。胶囊的 mg 与口服液的浓度不是“几粒/几毫升”可自行换算的答案；应按实际处方和该产品标签确认。", "en": "Check LYRICA, pregabalin, capsule or oral solution, stated strength and target market together. Capsule mg and oral-solution concentration are not an answer that can be self-converted into a number of capsules or millilitres; confirm from the actual prescription and product label." }, { "zh": "该 FDA 标签将头晕和嗜睡等列为需要留意的不良反应，也提示与其他中枢神经系统抑制性药物联用需额外核对。高龄、跌倒、饮酒，或同时使用助眠、镇静、止痛等产品时，应带完整药单向药师或医生确认。", "en": "This FDA label lists effects such as dizziness and somnolence for attention and flags combinations with other central-nervous-system depressants for extra review. With older age, falls, alcohol, or sleep, sedative or pain medicines, bring the full medicine list to a pharmacist or clinician." }, { "zh": "标签还提示不应自行突然停用。任何想减量、停用或在胶囊与口服液之间转换的情况，都应由开方团队按具体产品和病情给出安排，而不是按网页或包装照片操作。", "en": "The label also warns against self-directed abrupt discontinuation. Any taper, stop, or conversion between capsule and oral solution needs a plan from the prescribing team for the exact product and condition, not a webpage or package photo." } ], "source": { "id": "src_21858543296b9ccf", "label": "FDA：LYRICA 2025 美国处方信息（NDA 021446 / 022488）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/021446s046%2C022488s022lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "普瑞巴林怎样起作用：它与中枢神经系统电压门控钙通道的 α2-δ 位点高亲和结合", "en": "How pregabalin works: it binds with high affinity at the alpha2-delta site of voltage-gated calcium channels in the central nervous system" }, "summary": { "zh": "FDA 标签说明普瑞巴林与中枢神经系统电压门控钙通道辅助亚基 α2-δ 位点高亲和结合；其完整作用机制尚未完全阐明。标签也说明它虽在结构上与 GABA 有关，却不直接结合 GABAA、GABAB 或苯二氮䓬受体。机制解释的是药理线索，不判断个人疼痛、癫痫、焦虑、剂量或是否适合与其他镇静性药物同用。", "en": "The FDA label says pregabalin binds with high affinity at the alpha2-delta site, an auxiliary subunit of voltage-gated calcium channels in central-nervous-system tissues; its full mechanism is not completely understood. The label also says that although it is structurally related to GABA, it does not directly bind GABAA, GABAB or benzodiazepine receptors. Mechanism explains pharmacologic clues, not an individual's pain, seizure, anxiety, dose or suitability with another sedating medicine." }, "checks": [ { "zh": "名字或结构与 GABA 有关，不表示 LYRICA 就等同于苯二氮䓬类、助眠药、阿片类或其他镇静药，也不表示可自行叠加、替换或按毫克数换算。尤其在高龄、跌倒、饮酒或多药并用时，完整药单必须由专业人员核对。", "en": "A name or structural relationship to GABA does not make LYRICA equivalent to a benzodiazepine, sleep medicine, opioid or other sedative, or self-combinable, substitutable or convertible by milligrams. Especially with older age, falls, alcohol or multiple medicines, the complete medicine list needs professional review." }, { "zh": "钙通道 α2-δ 位点的机制不把胶囊、口服溶液、缓释产品或不同强度变成可以自行互换的同一产品。剂型、浓度、肾功能、实际包装和处方都必须作为完整信息核对。", "en": "An alpha2-delta calcium-channel mechanism does not turn capsules, oral solution, extended-release products or different strengths into one self-interchangeable product. Dosage form, concentration, kidney function, actual pack and prescription must be checked as complete information." }, { "zh": "嗜睡、头晕、意识改变、呼吸相关不适、跌倒或其他新症状，不能从机制页面判断应自行增减或停用。请带实际包装和完整药单联系当地医生、药师或需要时的紧急支持。", "en": "Drowsiness, dizziness, altered alertness, breathing-related discomfort, falls or another new symptom cannot be used with a mechanism page to decide self-increase, reduction or stopping. Contact a local clinician, pharmacist or, when needed, urgent support with the actual pack and complete medicine list." } ], "source": { "id": "src_21858543296b9ccf", "label": "FDA：LYRICA 2025 美国处方信息（临床药理）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/021446s046%2C022488s022lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "Lyrica", "generic": "普瑞巴林", "dosageFormClass": "口服胶囊 25/50/75/100/150/200/225/300 mg；口服溶液 20 mg/mL（本档案所列）" }, "labelSource": { "id": "src_21858543296b9ccf", "label": "FDA：LYRICA 2025 美国处方信息（NDA 021446 / 022488）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/021446s046%2C022488s022lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "productRoutes": [ { "source": { "id": "src_21858543296b9ccf", "label": "FDA：LYRICA 2025 美国处方信息（NDA 021446 / 022488）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/021446s046%2C022488s022lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_1a44b9231093d507", "label": "DailyMed（NLM）：LYRICA 公开标签", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=0c5d6728-be43-4e1b-9f14-a7ce920e12a3", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [ { "id": "fda-2019-gabapentinoid-serious-breathing-pregabalin", "issuedAt": "2019-12-19", "status": "fda_class_safety_communication", "title": { "zh": "FDA 药物安全通讯：包括 Lyrica（pregabalin）在内的加巴喷丁类药物严重呼吸问题风险沟通", "en": "FDA Drug Safety Communication: serious breathing-problem warning for gabapentinoids including Lyrica (pregabalin)" }, "summary": { "zh": "FDA 于 2019-12-19 发布药物安全通讯，明确列出 Lyrica（pregabalin），并说明在存在呼吸风险因素时使用加巴喷丁类药物可能出现严重呼吸困难；公告所列背景包括与阿片类镇痛药或其他中枢神经系统抑制药同用、降低肺功能的疾病及高龄。FDA 要求在美国加巴喷丁类药物处方信息中增加呼吸抑制风险警语。该记录是美国、特定日期的类别监管沟通，不表示手中任何 Lyrica 包装、其他剂型或市场、任何联用，或任何个人已发生问题，也不支持自行停药、减量、加量、换药或把 Lyrica 与其他镇静性药物自行叠加／拆分。出现呼吸困难、反应异常、难以唤醒或其他紧急症状时应立即使用当地急救服务；非紧急的联用或风险问题应连同实际包装和完整药单由开方团队或药师核对。", "en": "On 2019-12-19, FDA issued a Drug Safety Communication that explicitly lists Lyrica (pregabalin) and says serious breathing difficulties may occur with gabapentinoids in people with respiratory risk factors. The communication names use with opioid pain medicines or other central-nervous-system depressants, conditions that reduce lung function, and older age as context; FDA required respiratory-depression warnings in U.S. gabapentinoid prescribing information. This is a dated U.S. class regulatory communication. It does not mean that any Lyrica pack, another dosage form or market, any combination, or any individual has a problem, and it does not support self-stopping, reducing, increasing, switching, or independently adding/splitting Lyrica with another sedating medicine. Trouble breathing, unusual unresponsiveness, inability to wake, or another emergency requires local emergency services; non-emergency combination or risk questions need the actual pack and complete medicine list reviewed by a pharmacist or prescribing team." }, "source": { "id": "src_d155de4d5f6093e9", "label": "FDA：2019-12-19 加巴喷丁／普瑞巴林（含 Neurontin、Lyrica）严重呼吸问题药物安全通讯", "url": "https://www.fda.gov/safety/medical-product-safety-information/neurontin-gralise-horizant-gabapentin-and-lyrica-lyrica-cr-pregabalin-drug-safety-communication", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "DailyMed 的 LYRICA（pregabalin）当前美国公开标签列示 25–300 mg 口服胶囊与 20 mg/mL 口服溶液，并列出美国初始批准年份为 2004。不同剂型、强度、浓度、肾功能和实际处方不能只按商品名、每粒数或他人经验推定。", "history": "神经痛、带状疱疹后神经痛、纤维肌痛和癫痫相关的标签词不是自我诊断或自行换药依据。产品身份、适应症和实际使用方案需与目标市场现行标签及负责团队核对。", "sourceDocuments": [ { "id": "src_21858543296b9ccf", "label": "FDA：LYRICA 2025 美国处方信息（NDA 021446 / 022488）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/021446s046%2C022488s022lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_1a44b9231093d507", "label": "DailyMed（NLM）：LYRICA 公开标签", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=0c5d6728-be43-4e1b-9f14-a7ce920e12a3", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_5ed30b676fbb9773", "label": "FDA Drugs@FDA 官方检索入口", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_lookup_entry", "documentKind": "regulatory_lookup", "market": "US", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } ], "applicationNumber": "NDA 021446 / 022488", "approvalTimeline": [ { "date": "2004", "title": { "zh": "FDA 标签所列美国初始批准年份", "en": "Initial U.S. approval year listed in the FDA label" }, "detail": { "zh": "本页链接的 FDA 标签档案列示 Initial U.S. Approval: 2004。该历史定位不等同于当前批准、可得性、持有人或其他市场状态。", "en": "The FDA label archive linked here lists Initial U.S. Approval: 2004. This historical locator is not a conclusion about current approval, availability, holder or another market." }, "source": { "id": "src_21858543296b9ccf", "label": "FDA: LYRICA prescribing information", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/021446s046%2C022488s022lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, { "date": "2025", "title": { "zh": "FDA 标签档案版本", "en": "FDA label archive version" }, "detail": { "zh": "本页链接 2025 的 FDA 标签档案作为可复核阅读入口。现行标签、规格、适应症和安全信息必须另行以目标市场当前文件核对。", "en": "This page links the 2025 FDA label archive as a traceable reading entry point. Current labeling, strength, indication and safety information require separate verification against the target market’s current document." }, "source": { "id": "src_21858543296b9ccf", "label": "FDA: LYRICA prescribing information", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/021446s046%2C022488s022lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "已链接公开标签档案", "en": "Public label archive linked" }, "detail": { "zh": "仅对应本页所列 FDA 文件。", "en": "Only the FDA document listed on this page is linked." } }, { "market": { "zh": "中国大陆、欧盟、日本", "en": "Mainland China, EU, Japan" }, "status": { "zh": "待逐项建立市场记录", "en": "Market record not established" }, "detail": { "zh": "不从美国标签档案推定当地批准、持有人、规格、供应或可售资格。", "en": "No local approval, holder, strength, supply or sale-eligibility conclusion is inferred from the U.S. label archive." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "标签档案能代表现在的产品信息吗？", "en": "Does a label archive represent current product information?" }, "answer": { "zh": "不能自动代表。档案用于定位来源；需要以目标市场的现行官方标签逐项复核。", "en": "Not automatically. The archive locates a source; each point needs verification against the target market’s current official label." } }, { "question": { "zh": "为什么这里不展示价格或原研/仿制结论？", "en": "Why are price and originator/generic conclusions not shown?" }, "answer": { "zh": "这些结论需要产品、剂型、规格、包装、市场、日期和原始记录分别齐全并经人工审核；单一标签文件不足以支持。", "en": "Those conclusions require separately complete and human-reviewed product, dosage-form, strength, pack, market, date and primary-record fields; one label file is insufficient." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "how-to-read-a-drug-label", "regulatory-sources-first" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/lyrica/", "en": "https://origindrug.com/en/drugs/lyrica/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "keppra", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-17", "status": "published_traceable_archive" }, "names": { "brand": "Keppra", "generic": "左乙拉西坦", "aliases": [ "levetiracetam" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "神经与认知", "sourceArchiveMarket": "美国公开处方药标签档案", "dosageFormClass": "薄膜衣片：250 / 500 / 750 / 1000 mg；口服溶液：100 mg/mL（本档案所列）", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "1999（美国公开标签所列初始批准）", "archiveSponsorText": "DailyMed（NLM）公开标签档案" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-keppra-levetiracetam-tablet-250mg-ndc-50474-594-40", "marketCode": "US", "labelVersion": { "zh": "DailyMed 公开标签（UCB，2026-01 更新）", "en": "DailyMed public label (UCB, updated Jan 2026)" }, "dosageForm": { "zh": "KEPPRA 左乙拉西坦薄膜衣口服片", "en": "KEPPRA levetiracetam film-coated oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 50474-594-40", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片 250 mg；120 片瓶装", "en": "250 mg per tablet; 120-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=3ca9df05-a506-4ec8-a4fe-320f1219ab21&name=keppra-08.jpg", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "左乙拉西坦", "en": "levetiracetam" }, "value": 250, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签量；不是个人片数、换算或调药规则", "en": "labelled amount per tablet; not an individual's tablet count, conversion or adjustment rule" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "白色 HDPE 瓶", "en": "white HDPE bottle" }, "fill": null, "countPerPackage": 1, "countUnit": { "zh": "瓶/包", "en": "bottle per pack" }, "unitsPerContainer": { "count": 120, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-23", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 120, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "蓝色", "en": "blue" }, "shape": { "zh": "长圆形、薄膜衣、有刻痕片", "en": "oblong, film-coated, scored tablet" }, "imprint": "ucb 250", "scoreStatus": "scored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_6df3cfaae703b5de", "label": "DailyMed（NLM）：KEPPRA 左乙拉西坦当前美国公开标签（UCB，2026-01 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=3ca9df05-a506-4ec8-a4fe-320f1219ab21", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-keppra-levetiracetam-tablet-500mg-ndc-50474-595-40", "marketCode": "US", "labelVersion": { "zh": "DailyMed 公开标签（UCB，2026-01 更新）", "en": "DailyMed public label (UCB, updated Jan 2026)" }, "dosageForm": { "zh": "KEPPRA 左乙拉西坦薄膜衣口服片", "en": "KEPPRA levetiracetam film-coated oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 50474-595-40", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片 500 mg；120 片瓶装", "en": "500 mg per tablet; 120-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=3ca9df05-a506-4ec8-a4fe-320f1219ab21&name=keppra-09.jpg", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "左乙拉西坦", "en": "levetiracetam" }, "value": 500, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签量；不是个人片数、换算或调药规则", "en": "labelled amount per tablet; not an individual's tablet count, conversion or adjustment rule" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "白色 HDPE 瓶", "en": "white HDPE bottle" }, "fill": null, "countPerPackage": 1, "countUnit": { "zh": "瓶/包", "en": "bottle per pack" }, "unitsPerContainer": { "count": 120, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-23", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 120, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "黄色", "en": "yellow" }, "shape": { "zh": "长圆形、薄膜衣、有刻痕片", "en": "oblong, film-coated, scored tablet" }, "imprint": "ucb 500", "scoreStatus": "scored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_6df3cfaae703b5de", "label": "DailyMed（NLM）：KEPPRA 左乙拉西坦当前美国公开标签（UCB，2026-01 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=3ca9df05-a506-4ec8-a4fe-320f1219ab21", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-keppra-levetiracetam-tablet-750mg-ndc-50474-596-40", "marketCode": "US", "labelVersion": { "zh": "DailyMed 公开标签（UCB，2026-01 更新）", "en": "DailyMed public label (UCB, updated Jan 2026)" }, "dosageForm": { "zh": "KEPPRA 左乙拉西坦薄膜衣口服片", "en": "KEPPRA levetiracetam film-coated oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 50474-596-40", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片 750 mg；120 片瓶装", "en": "750 mg per tablet; 120-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=3ca9df05-a506-4ec8-a4fe-320f1219ab21&name=keppra-10.jpg", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "左乙拉西坦", "en": "levetiracetam" }, "value": 750, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签量；不是个人片数、换算或调药规则", "en": "labelled amount per tablet; not an individual's tablet count, conversion or adjustment rule" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "白色 HDPE 瓶", "en": "white HDPE bottle" }, "fill": null, "countPerPackage": 1, "countUnit": { "zh": "瓶/包", "en": "bottle per pack" }, "unitsPerContainer": { "count": 120, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-23", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 120, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "橙色", "en": "orange" }, "shape": { "zh": "长圆形、薄膜衣、有刻痕片", "en": "oblong, film-coated, scored tablet" }, "imprint": "ucb 750", "scoreStatus": "scored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_6df3cfaae703b5de", "label": "DailyMed（NLM）：KEPPRA 左乙拉西坦当前美国公开标签（UCB，2026-01 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=3ca9df05-a506-4ec8-a4fe-320f1219ab21", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-keppra-levetiracetam-tablet-1000mg-ndc-50474-597-66", "marketCode": "US", "labelVersion": { "zh": "DailyMed 公开标签（UCB，2026-01 更新）", "en": "DailyMed public label (UCB, updated Jan 2026)" }, "dosageForm": { "zh": "KEPPRA 左乙拉西坦薄膜衣口服片", "en": "KEPPRA levetiracetam film-coated oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 50474-597-66", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片 1000 mg；60 片瓶装", "en": "1000 mg per tablet; 60-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=3ca9df05-a506-4ec8-a4fe-320f1219ab21&name=keppra-11.jpg", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "左乙拉西坦", "en": "levetiracetam" }, "value": 1000, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签量；不是个人片数、换算或调药规则", "en": "labelled amount per tablet; not an individual's tablet count, conversion or adjustment rule" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "白色 HDPE 瓶", "en": "white HDPE bottle" }, "fill": null, "countPerPackage": 1, "countUnit": { "zh": "瓶/包", "en": "bottle per pack" }, "unitsPerContainer": { "count": 60, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-23", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 60, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "白色", "en": "white" }, "shape": { "zh": "长圆形、薄膜衣、有刻痕片", "en": "oblong, film-coated, scored tablet" }, "imprint": "ucb 1000", "scoreStatus": "scored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_6df3cfaae703b5de", "label": "DailyMed（NLM）：KEPPRA 左乙拉西坦当前美国公开标签（UCB，2026-01 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=3ca9df05-a506-4ec8-a4fe-320f1219ab21", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-keppra-levetiracetam-oral-solution-100mg-per-ml-473ml-bottle-ndc-50474-001-48", "marketCode": "US", "labelVersion": { "zh": "DailyMed 公开标签（UCB，2026-01 更新）", "en": "DailyMed public label (UCB, updated Jan 2026)" }, "dosageForm": { "zh": "KEPPRA 左乙拉西坦口服溶液", "en": "KEPPRA levetiracetam oral solution" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 50474-001-48", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "concentration", "primaryDisplay": { "zh": "100 mg/mL；473 mL（16 fl oz）瓶装", "en": "100 mg/mL; 473 mL (16 fl oz) bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=3ca9df05-a506-4ec8-a4fe-320f1219ab21&name=keppra-12.jpg", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "左乙拉西坦", "en": "levetiracetam" }, "value": 100, "unit": "mg", "basisCode": "concentration", "basisLabel": { "zh": "每 mL 标签浓度；不是个人 mL 数、换算或调药规则", "en": "labelled concentration per mL; not an individual's millilitre amount, conversion or adjustment rule" } } ], "concentration": { "basisCode": "mg_per_mL", "notation": null, "numerator": { "value": 100, "unit": "mg" }, "denominator": { "value": 1, "unit": "mL" }, "display": { "zh": "100 mg/mL", "en": "100 mg/mL" } }, "container": { "typeCode": "bottle", "typeLabel": { "zh": "白色 HDPE 瓶", "en": "white HDPE bottle" }, "fill": { "value": 473, "unit": "mL" }, "countPerPackage": 1, "countUnit": { "zh": "瓶/包", "en": "bottle per pack" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-23", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 1, "unit": { "zh": "473 mL 瓶装（16 fl oz）", "en": "473 mL bottle (16 fl oz)" } }, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_6df3cfaae703b5de", "label": "DailyMed（NLM）：KEPPRA 左乙拉西坦当前美国公开标签（UCB，2026-01 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=3ca9df05-a506-4ec8-a4fe-320f1219ab21", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-keppra-levetiracetam-tablet-500mg-ndc-50474-595-40", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=3ca9df05-a506-4ec8-a4fe-320f1219ab21&name=keppra-09.jpg", "alt": "KEPPRA 左乙拉西坦在美国 DailyMed UCB 公开标签中的 500 mg、120 片装容器标签图", "archiveMarket": "美国", "labelVersion": "DailyMed 公开标签（UCB, Inc.，2026-01 更新）", "presentation": "KEPPRA 左乙拉西坦薄膜衣片：每片 500 mg、120 片装容器标签图（DailyMed UCB, Inc. 公开标签所列）。", "notice": "此为美国 DailyMed UCB, Inc. 公开标签中明确对应 KEPPRA、左乙拉西坦 500 mg、120 片装的容器标签图，只帮助核对品牌、通用名、片剂、标示强度、包装数量和来源；不用于鉴定真伪，也不证明其他规格、口服溶液、其他包装、其他市场标签、当前可得性、原研身份、目标市场批准或可售资格。", "source": { "id": "src_6df3cfaae703b5de", "label": "DailyMed（NLM）：KEPPRA 左乙拉西坦公开标签（UCB, Inc.，2026-01 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=3ca9df05-a506-4ec8-a4fe-320f1219ab21", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "KEPPRA 说明书放大阅读：片剂的 mg 与口服溶液的 mg/mL 不是“几片／几毫升”的答案", "en": "KEPPRA label reading: tablet mg and oral-solution mg/mL are not answers to a tablet or millilitre count" }, "summary": { "zh": "本模块以 DailyMed 的 KEPPRA 美国公开标签为阅读入口，核对左乙拉西坦、片剂或口服溶液、标示强度／浓度和目标市场。它不提供个人剂量、液体换算、加量、转换、骤停或联用方案。", "en": "This module uses the DailyMed KEPPRA U.S. public label to check levetiracetam, tablet or oral solution, stated strength/concentration and target market. It does not provide an individual's dose, liquid conversion, escalation, conversion, abrupt stopping or combination plan." }, "checks": [ { "zh": "先核对 KEPPRA、左乙拉西坦、片剂或口服溶液、准确的 mg 或 mg/mL、包装和目标市场。mg 是一个单位中的标示量，mg/mL 是液体浓度；两者都不是网页能替任何人得出“今天该用多少”的答案。", "en": "First check KEPPRA, levetiracetam, tablet or oral solution, the exact mg or mg/mL wording, presentation and target market. mg is a stated amount in a unit and mg/mL is liquid concentration; neither lets a webpage determine what anyone should use today." }, { "zh": "标签说明片剂应整片吞服，不应咀嚼或研碎。刻痕、颜色、大小或与其他片剂相似，都不授权自行掰开、研碎、换成液体、按经验换算或用别的规格替代。", "en": "The label states that tablets should be swallowed whole and not chewed or crushed. A score line, colour, size or resemblance to another tablet does not authorise self-splitting, crushing, conversion to liquid, experience-based conversion or substitution with another strength." }, { "zh": "标签提示避免突然撤药，因为可能增加发作频率或出现癫痫持续状态风险；这不是让读者自行决定何时停用的说明。对漏用、药物转换、行为或情绪变化以及任何停药计划，应联系负责团队或药师核对准确产品与现行处方。", "en": "The label advises avoiding abrupt withdrawal because seizure frequency may increase or status epilepticus may occur; this is not an instruction for readers to decide when to stop. For a missed use, medicine transition, behavioural or mood change, or any stopping plan, contact the responsible team or pharmacist to review the exact product and current prescription." }, { "zh": "标签指出肾功能会影响左乙拉西坦的清除，老年人尤其需要谨慎核对肾功能相关资料。这个信息解释为何完整药单、实验室资料和处方需要专业复核，不构成任何个人调整、间隔改变或自行补用规则。", "en": "The label notes that renal function affects levetiracetam clearance and that older adults require particular care around renal-function information. This explains why the complete medicine list, laboratory information and prescription need professional review; it does not create an individual adjustment, interval-change or self-make-up rule." } ], "source": { "id": "src_6df3cfaae703b5de", "label": "DailyMed（NLM）：KEPPRA 左乙拉西坦公开标签（UCB, Inc.，2026-01 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=3ca9df05-a506-4ec8-a4fe-320f1219ab21", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "左乙拉西坦怎样起作用：标签明确写明其抗癫痫作用机制尚未完全确定", "en": "How levetiracetam works: the label explicitly says its exact antiepileptic mechanism is not fully known" }, "summary": { "zh": "KEPPRA 标签写明其精确抗癫痫作用机制尚未明确，并描述动物实验中观察到与突触囊泡蛋白 2A（SV2A）的结合可能有助于其作用。这里保留“可能”和证据边界：机制词用于理解资料，不用于预测个人疗效、决定诊断、剂量、联用或转换。", "en": "The KEPPRA label says its precise antiepileptic mechanism is unknown and describes experimental evidence that binding to synaptic vesicle protein 2A (SV2A) may contribute. This keeps the word 'may' and the evidence boundary: mechanism terms help read the source and do not predict individual response or decide diagnosis, dose, combination or switching." }, "checks": [ { "zh": "“SV2A”是一个标签中的实验与药理线索，不是任何一次发作、意识改变、跌倒或不适原因的诊断工具，也不能决定某个人是否应使用、增加或转换任何抗癫痫药。", "en": "“SV2A” is an experimental and pharmacologic clue in a label, not a diagnostic tool for a seizure, altered consciousness, fall or another concern, and it cannot decide whether someone should use, increase or switch any antiseizure medicine." }, { "zh": "即使另一种药也作用于神经系统，或名称、用途看似相关，也不能据此自行叠加、轮换、替代或把不同剂型按 mg 等量换算。完整药单、既往发作情况、肾功能相关资料和现行标签需要由专业人员一起评估。", "en": "Even if another medicine also affects the nervous system or seems related by name or use, this does not support self-combination, alternation, substitution or milligram-for-milligram conversion across dosage forms. The complete medicine list, seizure history, renal-function information and current label need professional review together." }, { "zh": "出现持续或反复发作、意识未恢复、严重皮疹或面部／气道肿胀、明显行为异常或其他急性问题，应优先使用当地紧急医疗或既有照护渠道；机制页面不能替代现场评估。", "en": "With persistent or repeated seizures, failure to regain consciousness, severe rash or face/airway swelling, marked behavioural change or another acute concern, prioritise local emergency care or established care pathways; a mechanism page cannot replace in-person assessment." } ], "source": { "id": "src_6df3cfaae703b5de", "label": "DailyMed（NLM）：KEPPRA 左乙拉西坦公开标签（UCB, Inc.，2026-01 更新；Clinical Pharmacology）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=3ca9df05-a506-4ec8-a4fe-320f1219ab21", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "Keppra", "generic": "左乙拉西坦", "dosageFormClass": "薄膜衣片：250 / 500 / 750 / 1000 mg；口服溶液：100 mg/mL（本档案所列）" }, "labelSource": { "id": "src_6df3cfaae703b5de", "label": "DailyMed（NLM）：KEPPRA 左乙拉西坦公开标签（UCB, Inc.，2026-01 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=3ca9df05-a506-4ec8-a4fe-320f1219ab21", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "productRoutes": [ { "source": { "id": "src_6df3cfaae703b5de", "label": "DailyMed（NLM）：KEPPRA 左乙拉西坦公开标签（UCB, Inc.，2026-01 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=3ca9df05-a506-4ec8-a4fe-320f1219ab21", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_3b6463247d31e848", "label": "FDA：KEPPRA 历史处方信息（2019）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021035s102%2C021505s042lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "DailyMed 的 KEPPRA（levetiracetam）美国公开标签列出 250、500、750、1000 mg 薄膜衣片及 100 mg/mL 口服溶液。页面帮助读者先区分准确产品、单位和目标市场；不据此生成个人剂量、液体与片剂换算、加减量、联用、停药或购买结论。", "history": "“500 mg”与“100 mg/mL”描述的是不同剂型中的标示强度或浓度，不能只看相似数字就换算片数或毫升数。该页面仅建立美国公开标签的阅读路径；任何实际使用、肾功能相关调整、转换或停用均必须由开方团队依据现行标签和个人情况完成。", "sourceDocuments": [ { "id": "src_6df3cfaae703b5de", "label": "DailyMed（NLM）：KEPPRA 左乙拉西坦公开标签（UCB, Inc.，2026-01 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=3ca9df05-a506-4ec8-a4fe-320f1219ab21", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_3b6463247d31e848", "label": "FDA：KEPPRA 历史处方信息（2019）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021035s102%2C021505s042lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } ], "applicationNumber": "NDA 021035 / 021505（DailyMed 公开标签所列美国市场标识）", "approvalTimeline": [ { "date": "1999", "title": { "zh": "FDA 标签所列美国初始批准年份", "en": "Initial U.S. approval year listed in the FDA label" }, "detail": { "zh": "本页链接的 FDA 标签档案列示 Initial U.S. Approval: 1999。该历史定位不等同于当前批准、可得性、持有人或其他市场状态。", "en": "The FDA label archive linked here lists Initial U.S. Approval: 1999. This historical locator is not a conclusion about current approval, availability, holder or another market." }, "source": { "id": "src_6df3cfaae703b5de", "label": "DailyMed: KEPPRA public label archive", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=3ca9df05-a506-4ec8-a4fe-320f1219ab21", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, { "date": "2026-01", "title": { "zh": "FDA 标签档案版本", "en": "FDA label archive version" }, "detail": { "zh": "本页链接 2026-01 的 FDA 标签档案作为可复核阅读入口。现行标签、规格、适应症和安全信息必须另行以目标市场当前文件核对。", "en": "This page links the 2026-01 FDA label archive as a traceable reading entry point. Current labeling, strength, indication and safety information require separate verification against the target market’s current document." }, "source": { "id": "src_6df3cfaae703b5de", "label": "DailyMed: KEPPRA public label archive", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=3ca9df05-a506-4ec8-a4fe-320f1219ab21", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "已链接公开标签档案", "en": "Public label archive linked" }, "detail": { "zh": "仅对应本页所列 FDA 文件。", "en": "Only the FDA document listed on this page is linked." } }, { "market": { "zh": "中国大陆、欧盟、日本", "en": "Mainland China, EU, Japan" }, "status": { "zh": "待逐项建立市场记录", "en": "Market record not established" }, "detail": { "zh": "不从美国标签档案推定当地批准、持有人、规格、供应或可售资格。", "en": "No local approval, holder, strength, supply or sale-eligibility conclusion is inferred from the U.S. label archive." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "标签档案能代表现在的产品信息吗？", "en": "Does a label archive represent current product information?" }, "answer": { "zh": "不能自动代表。档案用于定位来源；需要以目标市场的现行官方标签逐项复核。", "en": "Not automatically. The archive locates a source; each point needs verification against the target market’s current official label." } }, { "question": { "zh": "为什么这里不展示价格或原研/仿制结论？", "en": "Why are price and originator/generic conclusions not shown?" }, "answer": { "zh": "这些结论需要产品、剂型、规格、包装、市场、日期和原始记录分别齐全并经人工审核；单一标签文件不足以支持。", "en": "Those conclusions require separately complete and human-reviewed product, dosage-form, strength, pack, market, date and primary-record fields; one label file is insufficient." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "how-to-read-a-drug-label", "regulatory-sources-first" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/keppra/", "en": "https://origindrug.com/en/drugs/keppra/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "lamictal", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-23", "status": "published_traceable_archive" }, "names": { "brand": "LAMICTAL", "generic": "拉莫三嗪", "aliases": [ "LAMICTAL", "LAMICTAL ODT", "lamotrigine", "拉莫三嗪" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "神经与认知", "sourceArchiveMarket": "美国：DailyMed 当前公开处方药标签（2025-10-10 更新；仅建立所引文件的阅读入口）。不从这一美国文件推定中国大陆、欧盟、日本或其他市场的商品名、批准、供应、可售资格或可替代性。", "dosageFormClass": "拉莫三嗪口服普通片：25、100、150、200 mg；口服混悬用片：2、5、25 mg；口腔崩解片：25、50、100、200 mg（美国公开标签所列；本页只建立普通片 100 mg／100 片、150 mg／60 片、200 mg／60 片三个准确瓶装面板，不将其他剂型或包装合并）", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "1994（DailyMed 当前美国公开标签所列 Initial U.S. Approval）", "archiveSponsorText": "GlaxoSmithKline LLC / DailyMed（NLM）当前美国公开标签" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [ "lamotrigine generic tablet", "lamotrigine extended-release tablet", "拉莫三嗪缓释片" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-lamictal-lamotrigine-tablet-100mg-100-bottle-ndc-0173-0642-55", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前公开标签（2025-10-10 更新；SPL v44）", "en": "Current U.S. DailyMed public label (updated 10 Oct 2025; SPL v44)" }, "dosageForm": { "zh": "LAMICTAL 拉莫三嗪普通口服片", "en": "LAMICTAL lamotrigine immediate-release oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 0173-0642-55", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片拉莫三嗪 100 mg；100 片瓶装", "en": "Lamotrigine 100 mg per tablet; 100-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=lamictal-spl-graphic-15.jpg&setid=d7e3572d-56fe-4727-2bb4-013ccca22678&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "拉莫三嗪", "en": "lamotrigine" }, "value": 100, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签量；不是个人片数、加减量、重启、分片或换药规则", "en": "labelled amount per tablet; not an individual's tablet count, adjustment, restart, splitting or switching rule" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-23", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "桃色", "en": "peach" }, "shape": { "zh": "盾形刻痕片", "en": "shield-shaped scored tablet" }, "imprint": "LAMICTAL 100", "scoreStatus": "scored_status_not_a_split_instruction", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_4074bb01cbdfe8cd", "label": "DailyMed（NLM）：LAMICTAL 拉莫三嗪普通片当前美国公开标签（GSK；2025-10-10 更新；SPL v44）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d7e3572d-56fe-4727-2bb4-013ccca22678", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-lamictal-lamotrigine-tablet-150mg-60-bottle-ndc-0173-0643-60", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前公开标签（2025-10-10 更新；SPL v44）", "en": "Current U.S. DailyMed public label (updated 10 Oct 2025; SPL v44)" }, "dosageForm": { "zh": "LAMICTAL 拉莫三嗪普通口服片", "en": "LAMICTAL lamotrigine immediate-release oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 0173-0643-60", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片拉莫三嗪 150 mg；60 片瓶装", "en": "Lamotrigine 150 mg per tablet; 60-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=lamictal-spl-graphic-16.jpg&setid=d7e3572d-56fe-4727-2bb4-013ccca22678&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "拉莫三嗪", "en": "lamotrigine" }, "value": 150, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签量；不是个人片数、加减量、重启、分片或换药规则", "en": "labelled amount per tablet; not an individual's tablet count, adjustment, restart, splitting or switching rule" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 60, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-23", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 60, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "乳白色", "en": "cream" }, "shape": { "zh": "盾形刻痕片", "en": "shield-shaped scored tablet" }, "imprint": "LAMICTAL 150", "scoreStatus": "scored_status_not_a_split_instruction", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_4074bb01cbdfe8cd", "label": "DailyMed（NLM）：LAMICTAL 拉莫三嗪普通片当前美国公开标签（GSK；2025-10-10 更新；SPL v44）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d7e3572d-56fe-4727-2bb4-013ccca22678", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-lamictal-lamotrigine-tablet-200mg-60-bottle-ndc-0173-0644-60", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前公开标签（2025-10-10 更新；SPL v44）", "en": "Current U.S. DailyMed public label (updated 10 Oct 2025; SPL v44)" }, "dosageForm": { "zh": "LAMICTAL 拉莫三嗪普通口服片", "en": "LAMICTAL lamotrigine immediate-release oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 0173-0644-60", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片拉莫三嗪 200 mg；60 片瓶装", "en": "Lamotrigine 200 mg per tablet; 60-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=lamictal-spl-graphic-17.jpg&setid=d7e3572d-56fe-4727-2bb4-013ccca22678&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "拉莫三嗪", "en": "lamotrigine" }, "value": 200, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签量；不是个人片数、加减量、重启、分片或换药规则", "en": "labelled amount per tablet; not an individual's tablet count, adjustment, restart, splitting or switching rule" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 60, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-23", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 60, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "蓝色", "en": "blue" }, "shape": { "zh": "盾形刻痕片", "en": "shield-shaped scored tablet" }, "imprint": "LAMICTAL 200", "scoreStatus": "scored_status_not_a_split_instruction", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_4074bb01cbdfe8cd", "label": "DailyMed（NLM）：LAMICTAL 拉莫三嗪普通片当前美国公开标签（GSK；2025-10-10 更新；SPL v44）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d7e3572d-56fe-4727-2bb4-013ccca22678", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-lamictal-lamotrigine-tablet-100mg-100-bottle-ndc-0173-0642-55", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=lamictal-spl-graphic-15.jpg&setid=d7e3572d-56fe-4727-2bb4-013ccca22678&type=img", "alt": "LAMICTAL 拉莫三嗪 100 mg、NDC 0173-0642-55、100 片瓶装在美国 DailyMed 当前公开标签中的展示面", "archiveMarket": "美国", "labelVersion": "DailyMed 当前公开标签（2025-10-10 更新；SPL v44）", "presentation": "LAMICTAL 拉莫三嗪：每片 100 mg，NDC 0173-0642-55，100 片瓶装展示面。", "notice": "此图只对应美国 DailyMed 当前公开标签中的 LAMICTAL、拉莫三嗪 100 mg、NDC 0173-0642-55 与 100 片瓶装。它只帮助核对品牌、通用名、每片标示量、普通口服片、包装数量、外观线索与来源；不用于鉴定真伪，也不证明 25 mg、150 mg、200 mg、口服混悬用片、口腔崩解片、启动套装、其他包装、其他市场、原研身份、当前可得性、可替代性或任何个人的片数、加减量、重启、分片、联用、停用或换药方案。", "source": { "id": "src_4074bb01cbdfe8cd", "label": "DailyMed（NLM）：LAMICTAL 拉莫三嗪普通片当前美国公开标签（GSK；2025-10-10 更新；SPL v44）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d7e3572d-56fe-4727-2bb4-013ccca22678", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "LAMICTAL 说明书放大阅读：普通片、口服混悬用片与口腔崩解片不能只按 mg 当成同一种产品", "en": "LAMICTAL label reading: standard tablets, tablets for oral suspension and ODTs are not one product just because the mg numbers look alike" }, "summary": { "zh": "本模块以 GSK 的 DailyMed 2025-10 美国公开标签为阅读入口，帮助核对 LAMICTAL、拉莫三嗪、准确剂型、每单位 mg 和目标市场。它不提供个人片数、加量、重启、停用、转换或联用方案。", "en": "This module uses GSK's October 2025 U.S. DailyMed public label to check LAMICTAL, lamotrigine, the exact dosage form, milligrams per unit and target market. It does not provide an individual's tablet count, escalation, restart, stopping, switching or combination plan." }, "checks": [ { "zh": "先分清普通片、口服混悬用片和口腔崩解片。25 mg、100 mg 等数字先是标签中某一准确制剂的单位标示量；它们不是网页能为任何人得出“今天吃几片”、把片剂改成另一剂型或按数字自行配量的答案。", "en": "First distinguish standard tablets, tablets for oral suspension and orally disintegrating tablets. Numbers such as 25 mg and 100 mg are labelled amounts for one exact formulation; they do not let a webpage determine a tablet count, change form or assemble an amount for anyone." }, { "zh": "标签提示严重皮疹风险，并将与丙戊酸相关产品共同使用、开始/加量过程及 HLA-B*1502 等列为需要专业处理的线索。这不等于每个人都应做某项检测，也不允许根据网页自行开始、重启、调量或停药。", "en": "The label flags serious-rash risk and identifies co-use with valproate-related products, the initiation/escalation process and HLA-B*1502 as matters for professional management. This neither means everyone needs a particular test nor permits self-starting, restarting, adjusting or stopping from a webpage." }, { "zh": "标签还列出与激素类避孕产品、其他抗癫痫药、抗感染药及蛋白酶抑制剂等相关的相互作用线索。家中有多种慢病药、避孕产品、抗感染药、草本或近期处方变化时，应把每一个实际药盒和完整药单交给药师或开方团队；不要按名称、用途或 mg 自行叠加、轮换或替代。", "en": "The label also lists interaction cues involving estrogen-containing contraceptive products, other antiseizure medicines, anti-infectives and protease inhibitors. With several chronic medicines, contraceptive products, anti-infectives, herbs or a recent prescription change, have a pharmacist or prescriber review every actual pack and the complete medicine list; do not self-combine, alternate or substitute from name, use or mg alone." }, { "zh": "新出现的皮疹、发热、口腔/眼部黏膜问题、面部或气道肿胀、晕厥、意识改变、持续或反复发作、自伤想法或其他急性严重不适，应及时使用当地紧急医疗或既有照护渠道；不要等待网页或自行改变药物。", "en": "With a new rash, fever, mouth/eye mucosal concern, face or airway swelling, fainting, altered consciousness, persistent/repeated seizures, self-harm thoughts or another acute serious concern, use local urgent or established care promptly; do not wait for a webpage or self-change the medicine." } ], "source": { "id": "src_4074bb01cbdfe8cd", "label": "DailyMed（NLM）：LAMICTAL 拉莫三嗪普通片、口服混悬用片及口腔崩解片当前美国公开标签（GSK；2025-10-10 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d7e3572d-56fe-4727-2bb4-013ccca22678", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "拉莫三嗪怎样起作用：标签明确保留“抗癫痫作用的精确机制尚未确定”", "en": "How lamotrigine works: the label explicitly retains that the precise anticonvulsant mechanism is not established" }, "summary": { "zh": "DailyMed 标签写明拉莫三嗪的精确抗癫痫作用机制尚未确定；它描述一种仍待在人类中证实的机制假说，即可能影响电压敏感性钠通道并调节兴奋性氨基酸递质释放。标签也写明其在双相障碍中的治疗作用机制尚未建立。这里保留不确定性，不把机制词变成诊断、个人疗效、基因解读、剂量、联用或换药结论。", "en": "The DailyMed label says lamotrigine's precise anticonvulsant mechanism is unknown. It describes a proposed mechanism whose relevance in humans remains to be established: possible effects on voltage-sensitive sodium channels and presynaptic release of excitatory amino-acid transmitters. The label also says its therapeutic mechanisms in bipolar disorder are not established. This preserves uncertainty rather than turning mechanism terms into diagnosis, individual response, genetic interpretation, dose, combination or switching conclusions." }, "checks": [ { "zh": "“钠通道”“谷氨酸”或“稳定神经膜”是标签中的实验/药理线索，不是判断某次发作、情绪变化、头晕、皮疹或其他不适原因的工具，也不能决定个人是否适合开始、加量、减少、停用或换药。", "en": "“Sodium channels,” “glutamate” or “membrane stabilisation” are experimental/pharmacologic cues in the label, not tools for deciding the cause of a seizure, mood change, dizziness, rash or another concern, and cannot decide whether someone should start, increase, reduce, stop or switch." }, { "zh": "即使另一种药也与癫痫、情绪、神经系统或相近机制有关，都不表示可以自行叠加、交替、以 mg 换算或用余药替代。准确剂型、完整药单、既往反应、检查资料和现行标签需要由专业人员一并核对。", "en": "Even if another medicine also relates to seizures, mood, the nervous system or a similar mechanism, this does not support self-combination, alternation, milligram conversion or use of leftovers as a substitute. Exact formulation, complete medicine list, prior reactions, relevant tests and current label need professional review together." }, { "zh": "机制页面不能处理严重皮疹警讯、意识改变、持续发作、心律相关症状或自伤风险。发生急性或严重问题时，应优先使用当地紧急医疗支持或联系负责团队，而不是根据网页试验不同规格、剂型或组合。", "en": "A mechanism page cannot manage serious-rash warning signs, altered consciousness, persistent seizures, rhythm-related symptoms or self-harm risk. With an acute or serious concern, prioritise local urgent care or the responsible team rather than experimenting with another strength, formulation or combination from a webpage." } ], "source": { "id": "src_4074bb01cbdfe8cd", "label": "DailyMed（NLM）：LAMICTAL 拉莫三嗪当前美国公开标签（GSK；2025-10-10 更新；Clinical Pharmacology）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d7e3572d-56fe-4727-2bb4-013ccca22678", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "LAMICTAL", "generic": "拉莫三嗪", "dosageFormClass": "拉莫三嗪口服普通片：25、100、150、200 mg；口服混悬用片：2、5、25 mg；口腔崩解片：25、50、100、200 mg（美国公开标签所列；本页只建立普通片 100 mg／100 片、150 mg／60 片、200 mg／60 片三个准确瓶装面板，不将其他剂型或包装合并）" }, "labelSource": { "id": "src_4074bb01cbdfe8cd", "label": "DailyMed（NLM）：LAMICTAL 拉莫三嗪普通片、口服混悬用片及口腔崩解片当前美国公开标签（GSK；2025-10-10 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d7e3572d-56fe-4727-2bb4-013ccca22678", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "productRoutes": [ { "source": { "id": "src_4074bb01cbdfe8cd", "label": "DailyMed（NLM）：LAMICTAL 拉莫三嗪普通片、口服混悬用片及口腔崩解片当前美国公开标签（GSK；2025-10-10 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d7e3572d-56fe-4727-2bb4-013ccca22678", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-23", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-23", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "DailyMed 的 LAMICTAL（lamotrigine）当前美国公开标签把普通片、口服混悬用片和口腔崩解片分列。mg 是各准确产品单位的标示量；同名、相同通用名或相近数字并不能回答个人应吃几片、能否把一类换成另一类、能否与其他抗癫痫或精神类药同用，或是否该重新开始。", "history": "该美国公开标签列示 Initial U.S. Approval: 1994，并在 2025-10 更新。它还列出严重皮疹的加框警告及与其他药物相关的专业核对事项。标签版本和历史节点只定位所引美国资料，不能替代手中产品的现行说明书、处方判断或目标市场记录。", "sourceDocuments": [ { "id": "src_4074bb01cbdfe8cd", "label": "DailyMed（NLM）：LAMICTAL 拉莫三嗪普通片、口服混悬用片及口腔崩解片当前美国公开标签（GSK；2025-10-10 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d7e3572d-56fe-4727-2bb4-013ccca22678", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" } ], "applicationNumber": "DailyMed 当前美国公开标签所列 New Drug Application 记录（本档案不另行断言具体申请号）", "approvalTimeline": [ { "date": "1994", "title": { "zh": "FDA 标签所列美国初始批准年份", "en": "Initial U.S. approval year listed in the FDA label" }, "detail": { "zh": "本页链接的 FDA 标签档案列示 Initial U.S. Approval: 1994。该历史定位不等同于当前批准、可得性、持有人或其他市场状态。", "en": "The FDA label archive linked here lists Initial U.S. Approval: 1994. This historical locator is not a conclusion about current approval, availability, holder or another market." }, "source": { "id": "src_4074bb01cbdfe8cd", "label": "DailyMed: LAMICTAL current U.S. public label", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d7e3572d-56fe-4727-2bb4-013ccca22678", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" } }, { "date": "2025-10-10", "title": { "zh": "FDA 标签档案版本", "en": "FDA label archive version" }, "detail": { "zh": "本页链接 2025-10-10 的 FDA 标签档案作为可复核阅读入口。现行标签、规格、适应症和安全信息必须另行以目标市场当前文件核对。", "en": "This page links the 2025-10-10 FDA label archive as a traceable reading entry point. Current labeling, strength, indication and safety information require separate verification against the target market’s current document." }, "source": { "id": "src_4074bb01cbdfe8cd", "label": "DailyMed: LAMICTAL current U.S. public label", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d7e3572d-56fe-4727-2bb4-013ccca22678", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "已链接公开标签档案", "en": "Public label archive linked" }, "detail": { "zh": "仅对应本页所列 FDA 文件。", "en": "Only the FDA document listed on this page is linked." } }, { "market": { "zh": "中国大陆、欧盟、日本", "en": "Mainland China, EU, Japan" }, "status": { "zh": "待逐项建立市场记录", "en": "Market record not established" }, "detail": { "zh": "不从美国标签档案推定当地批准、持有人、规格、供应或可售资格。", "en": "No local approval, holder, strength, supply or sale-eligibility conclusion is inferred from the U.S. label archive." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "标签档案能代表现在的产品信息吗？", "en": "Does a label archive represent current product information?" }, "answer": { "zh": "不能自动代表。档案用于定位来源；需要以目标市场的现行官方标签逐项复核。", "en": "Not automatically. The archive locates a source; each point needs verification against the target market’s current official label." } }, { "question": { "zh": "为什么这里不展示价格或原研/仿制结论？", "en": "Why are price and originator/generic conclusions not shown?" }, "answer": { "zh": "这些结论需要产品、剂型、规格、包装、市场、日期和原始记录分别齐全并经人工审核；单一标签文件不足以支持。", "en": "Those conclusions require separately complete and human-reviewed product, dosage-form, strength, pack, market, date and primary-record fields; one label file is insufficient." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "how-to-read-a-drug-label", "regulatory-sources-first" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/lamictal/", "en": "https://origindrug.com/en/drugs/lamictal/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "neurontin", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-23", "status": "published_traceable_archive" }, "names": { "brand": "Neurontin", "generic": "加巴喷丁", "aliases": [ "gabapentin" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "神经与认知", "sourceArchiveMarket": "美国 DailyMed 当前公开标签（页面 2026-05-12 更新；处方信息 2025-04 修订；本档案分别建立六种准确包装身份，不代表供应）", "dosageFormClass": "NEURONTIN 加巴喷丁：100 / 300 / 400 mg 口服胶囊、600 / 800 mg 薄膜衣刻痕片、250 mg/5 mL 口服溶液（美国公开标签所列；本页分别建立五种 100 单位瓶装与一瓶 470 mL 口服液身份，不将不同剂型、包装或其他市场合并）", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "1993（当前美国公开标签所列初始批准）", "archiveSponsorText": "Viatris Specialty LLC / DailyMed 当前美国公开标签" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-neurontin-gabapentin-capsule-100mg-100-bottle-ndc-5815128101", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（页面 2026-05-12 更新；处方信息 2025-04 修订）；仅为所引公开标签展示面，不代表供应", "en": "Current U.S. DailyMed public label (page updated 12 May 2026; prescribing information revised Apr 2025); cited public label panel only, not availability" }, "dosageForm": { "zh": "NEURONTIN 加巴喷丁口服胶囊", "en": "NEURONTIN gabapentin oral capsule" }, "route": { "zh": "口服（标签产品身份字段）", "en": "oral (label product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 58151-281-01", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_capsule", "primaryDisplay": { "zh": "每粒加巴喷丁 100 mg；100 粒瓶装", "en": "Gabapentin 100 mg per capsule; 100-capsule bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=image-07.jpg&setid=97935fd9-1d4a-43b6-a5d9-de994591187b&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "加巴喷丁", "en": "gabapentin" }, "value": 100, "unit": "mg", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒标签标示量；不是个人粒数、分割、转换、停用、联用或换药指令", "en": "labelled amount per capsule; not an individual's capsules count, splitting, conversion, stopping, co-use or switching instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-23", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "physicalClues": { "color": { "zh": "白色", "en": "white" }, "shape": { "zh": "硬明胶胶囊；无刻痕", "en": "hard-gelatin capsule; no score" }, "imprint": "VLE / Neurontin / 100 mg", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_001b52fb3a445c0f", "label": "DailyMed（NLM）：NEURONTIN 加巴喷丁当前美国公开标签（Viatris Specialty LLC；页面 2026-05-12 更新；处方信息 2025-04 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=97935fd9-1d4a-43b6-a5d9-de994591187b", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-neurontin-gabapentin-capsule-300mg-100-bottle-ndc-5815128201", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（页面 2026-05-12 更新；处方信息 2025-04 修订）；仅为所引公开标签展示面，不代表供应", "en": "Current U.S. DailyMed public label (page updated 12 May 2026; prescribing information revised Apr 2025); cited public label panel only, not availability" }, "dosageForm": { "zh": "NEURONTIN 加巴喷丁口服胶囊", "en": "NEURONTIN gabapentin oral capsule" }, "route": { "zh": "口服（标签产品身份字段）", "en": "oral (label product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 58151-282-01", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_capsule", "primaryDisplay": { "zh": "每粒加巴喷丁 300 mg；100 粒瓶装", "en": "Gabapentin 300 mg per capsule; 100-capsule bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=image-08.jpg&setid=97935fd9-1d4a-43b6-a5d9-de994591187b&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "加巴喷丁", "en": "gabapentin" }, "value": 300, "unit": "mg", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒标签标示量；不是个人粒数、分割、转换、停用、联用或换药指令", "en": "labelled amount per capsule; not an individual's capsules count, splitting, conversion, stopping, co-use or switching instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-23", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "physicalClues": { "color": { "zh": "黄色", "en": "yellow" }, "shape": { "zh": "硬明胶胶囊；无刻痕", "en": "hard-gelatin capsule; no score" }, "imprint": "VLE / Neurontin / 300 mg", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_001b52fb3a445c0f", "label": "DailyMed（NLM）：NEURONTIN 加巴喷丁当前美国公开标签（Viatris Specialty LLC；页面 2026-05-12 更新；处方信息 2025-04 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=97935fd9-1d4a-43b6-a5d9-de994591187b", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-neurontin-gabapentin-capsule-400mg-100-bottle-ndc-5815128301", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（页面 2026-05-12 更新；处方信息 2025-04 修订）；仅为所引公开标签展示面，不代表供应", "en": "Current U.S. DailyMed public label (page updated 12 May 2026; prescribing information revised Apr 2025); cited public label panel only, not availability" }, "dosageForm": { "zh": "NEURONTIN 加巴喷丁口服胶囊", "en": "NEURONTIN gabapentin oral capsule" }, "route": { "zh": "口服（标签产品身份字段）", "en": "oral (label product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 58151-283-01", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_capsule", "primaryDisplay": { "zh": "每粒加巴喷丁 400 mg；100 粒瓶装", "en": "Gabapentin 400 mg per capsule; 100-capsule bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=image-09.jpg&setid=97935fd9-1d4a-43b6-a5d9-de994591187b&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "加巴喷丁", "en": "gabapentin" }, "value": 400, "unit": "mg", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒标签标示量；不是个人粒数、分割、转换、停用、联用或换药指令", "en": "labelled amount per capsule; not an individual's capsules count, splitting, conversion, stopping, co-use or switching instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-23", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "physicalClues": { "color": { "zh": "橙色", "en": "orange" }, "shape": { "zh": "硬明胶胶囊；无刻痕", "en": "hard-gelatin capsule; no score" }, "imprint": "VLE / Neurontin / 400 mg", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_001b52fb3a445c0f", "label": "DailyMed（NLM）：NEURONTIN 加巴喷丁当前美国公开标签（Viatris Specialty LLC；页面 2026-05-12 更新；处方信息 2025-04 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=97935fd9-1d4a-43b6-a5d9-de994591187b", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-neurontin-gabapentin-tablet-600mg-100-bottle-ndc-5815128401", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（页面 2026-05-12 更新；处方信息 2025-04 修订）；仅为所引公开标签展示面，不代表供应", "en": "Current U.S. DailyMed public label (page updated 12 May 2026; prescribing information revised Apr 2025); cited public label panel only, not availability" }, "dosageForm": { "zh": "NEURONTIN 加巴喷丁口服薄膜衣刻痕片", "en": "NEURONTIN gabapentin scored film-coated oral tablet" }, "route": { "zh": "口服（标签产品身份字段）", "en": "oral (label product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 58151-284-01", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片加巴喷丁 600 mg；100 片瓶装", "en": "Gabapentin 600 mg per tablet; 100-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=image-10.jpg&setid=97935fd9-1d4a-43b6-a5d9-de994591187b&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "加巴喷丁", "en": "gabapentin" }, "value": 600, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、分割、转换、停用、联用或换药指令", "en": "labelled amount per tablet; not an individual's tablets count, splitting, conversion, stopping, co-use or switching instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-23", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "白色", "en": "white" }, "shape": { "zh": "椭圆形薄膜衣刻痕片", "en": "elliptical scored film-coated tablet" }, "imprint": "NT / 16", "scoreStatus": "scored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_001b52fb3a445c0f", "label": "DailyMed（NLM）：NEURONTIN 加巴喷丁当前美国公开标签（Viatris Specialty LLC；页面 2026-05-12 更新；处方信息 2025-04 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=97935fd9-1d4a-43b6-a5d9-de994591187b", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-neurontin-gabapentin-tablet-800mg-100-bottle-ndc-5815128501", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（页面 2026-05-12 更新；处方信息 2025-04 修订）；仅为所引公开标签展示面，不代表供应", "en": "Current U.S. DailyMed public label (page updated 12 May 2026; prescribing information revised Apr 2025); cited public label panel only, not availability" }, "dosageForm": { "zh": "NEURONTIN 加巴喷丁口服薄膜衣刻痕片", "en": "NEURONTIN gabapentin scored film-coated oral tablet" }, "route": { "zh": "口服（标签产品身份字段）", "en": "oral (label product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 58151-285-01", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片加巴喷丁 800 mg；100 片瓶装", "en": "Gabapentin 800 mg per tablet; 100-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=image-11.jpg&setid=97935fd9-1d4a-43b6-a5d9-de994591187b&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "加巴喷丁", "en": "gabapentin" }, "value": 800, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、分割、转换、停用、联用或换药指令", "en": "labelled amount per tablet; not an individual's tablets count, splitting, conversion, stopping, co-use or switching instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-23", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "白色", "en": "white" }, "shape": { "zh": "椭圆形薄膜衣刻痕片", "en": "elliptical scored film-coated tablet" }, "imprint": "NT / 26", "scoreStatus": "scored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_001b52fb3a445c0f", "label": "DailyMed（NLM）：NEURONTIN 加巴喷丁当前美国公开标签（Viatris Specialty LLC；页面 2026-05-12 更新；处方信息 2025-04 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=97935fd9-1d4a-43b6-a5d9-de994591187b", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-neurontin-gabapentin-oral-solution-250mg-per-5ml-470ml-bottle-ndc-5815129035", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（页面 2026-05-12 更新；处方信息 2025-04 修订）；仅为所引公开标签展示面，不代表供应", "en": "Current U.S. DailyMed public label (page updated 12 May 2026; prescribing information revised Apr 2025); cited public label panel only, not availability" }, "dosageForm": { "zh": "NEURONTIN 加巴喷丁口服溶液", "en": "NEURONTIN gabapentin oral solution" }, "route": { "zh": "口服（标签产品身份字段）", "en": "oral (label product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 58151-290-35", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_5_mL", "primaryDisplay": { "zh": "每 5 mL 加巴喷丁 250 mg；470 mL 瓶装", "en": "Gabapentin 250 mg per 5 mL; 470 mL bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=image-12.jpg&setid=97935fd9-1d4a-43b6-a5d9-de994591187b&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "加巴喷丁", "en": "gabapentin" }, "value": 250, "unit": "mg", "basisCode": "per_5_mL", "basisLabel": { "zh": "每 5 mL 标签标示量；不是个人毫升数、转换、停用、联用或换药指令", "en": "labelled amount per 5 mL; not an individual's millilitre amount, conversion, stopping, co-use or switching instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 470, "countUnit": { "zh": "mL/瓶", "en": "mL per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-23", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 470, "unit": { "zh": "mL/瓶", "en": "mL per bottle" } }, "physicalClues": { "color": { "zh": "澄清无色至微黄色溶液", "en": "clear, colourless to slightly yellow solution" }, "shape": { "zh": "口服液体；不适用片剂/胶囊外观", "en": "oral liquid; tablet/capsule shape not applicable" }, "imprint": "N/A", "scoreStatus": "not_applicable", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_001b52fb3a445c0f", "label": "DailyMed（NLM）：NEURONTIN 加巴喷丁当前美国公开标签（Viatris Specialty LLC；页面 2026-05-12 更新；处方信息 2025-04 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=97935fd9-1d4a-43b6-a5d9-de994591187b", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-neurontin-gabapentin-capsule-100mg-100-bottle-ndc-5815128101", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=image-07.jpg&setid=97935fd9-1d4a-43b6-a5d9-de994591187b&type=img", "alt": "NEURONTIN 加巴喷丁 100 mg、NDC 58151-281-01、100 粒瓶装在美国 DailyMed 当前公开标签中的展示面", "archiveMarket": "美国", "labelVersion": "DailyMed 当前公开标签（页面 2026-05-12 更新；处方信息 2025-04 修订）", "presentation": "NEURONTIN 加巴喷丁口服胶囊：每粒 100 mg，NDC 58151-281-01，100 粒瓶装展示面。", "notice": "此图只对应美国 DailyMed 当前公开标签中的 NEURONTIN、加巴喷丁 100 mg、NDC 58151-281-01 与 100 粒瓶装。它只帮助核对品牌、通用名、每粒标示量、胶囊、包装数量、外观线索与来源；不用于鉴定真伪，也不证明 300/400 mg 胶囊、600/800 mg 刻痕片、250 mg/5 mL 口服溶液、其他包装、其他市场、原研身份、当前可得性、可替代性或任何个人的粒数、片数、毫升数、分割、调量、联用、停用或换药方案。", "source": { "id": "src_001b52fb3a445c0f", "label": "DailyMed（NLM）：NEURONTIN 加巴喷丁当前美国公开标签（Viatris Specialty LLC；页面 2026-05-12 更新；处方信息 2025-04 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=97935fd9-1d4a-43b6-a5d9-de994591187b", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "NEURONTIN 说明书放大阅读：胶囊、刻痕片与口服液的数字不能互相代算", "en": "NEURONTIN label reading: capsule, scored-tablet and oral-solution numbers cannot be converted by guesswork" }, "summary": { "zh": "本模块以 DailyMed 的 NEURONTIN 美国公开标签为阅读入口，核对加巴喷丁、准确剂型、mg 或 mg/5 mL、包装和目标市场。它不提供个人片数、毫升数、加减量、换剂型、联用或停药方案。", "en": "This module uses the DailyMed NEURONTIN U.S. public label to check gabapentin, exact dosage form, mg or mg/5 mL, package and target market. It does not provide an individual's tablet count, millilitre amount, escalation, reduction, form switch, combination or stopping plan." }, "checks": [ { "zh": "先分清胶囊、600／800 mg 刻痕片和 250 mg/5 mL 口服溶液。mg 表示一个确定单位中的标示量，mg/5 mL 表示液体浓度；它们不是网页可以替任何人推导“该吃几粒／几毫升”的答案。", "en": "First distinguish capsules, 600/800 mg scored tablets and 250 mg/5 mL oral solution. mg is the stated amount in a defined unit, while mg/5 mL is a liquid concentration; neither lets a webpage derive how many units or millilitres any person should use." }, { "zh": "标签写明胶囊应整粒随水吞服。仅对该准确品牌的 600／800 mg 刻痕片说明了可能分半时余半片的标签处置；这不授权把胶囊打开、把任何片剂掰半、研碎，或把其他规格、市场与剂型按经验替代。", "en": "The label states that capsules should be swallowed whole with water. It separately addresses a remaining half only when this exact brand's 600/800 mg scored tablet is divided; that does not authorise opening capsules, splitting or crushing any tablet, or experience-based substitution across strengths, markets or forms." }, { "zh": "标签提示减量、停用或改用另一种药物应逐渐完成，且不应突然或快速停用。它不是让读者自行安排速度或时点的指令；对漏用、转换、嗜睡、头晕、跌倒或其他不适，应联系负责团队或药师核对。", "en": "The label says dose reduction, discontinuation or substitution with another medicine should be gradual and not abrupt or rapid. It is not an instruction for readers to choose a speed or timing; for a missed use, transition, sleepiness, dizziness, a fall or another concern, contact the responsible team or pharmacist for review." }, { "zh": "标签指出肾功能与老年人的用药资料需要格外谨慎核对，并提示与中枢抑制药（尤其阿片类）合用时存在呼吸抑制和镇静风险。它解释为何完整药单和肾功能相关资料必须由专业人员审阅，不构成任何个人调整或组合规则。", "en": "The label calls for particular care with renal-function information and older adults, and warns of respiratory-depression and sedation risk with CNS depressants, especially opioids. This explains why the complete medicine list and renal-function information need professional review; it does not create an individual adjustment or combination rule." } ], "source": { "id": "src_001b52fb3a445c0f", "label": "DailyMed（NLM）：NEURONTIN 加巴喷丁当前美国公开标签（Viatris Specialty LLC；页面 2026-05-12 更新；处方信息 2025-04 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=97935fd9-1d4a-43b6-a5d9-de994591187b", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "加巴喷丁怎样起作用：标签明确写明其镇痛与抗癫痫作用的精确机制尚未确定", "en": "How gabapentin works: the label says its precise analgesic and antiepileptic mechanisms are not established" }, "summary": { "zh": "NEURONTIN 标签写明加巴喷丁的精确镇痛和抗癫痫机制尚未确定；体外研究显示它可高亲和力结合电压激活钙通道的 α2δ 亚基，但该结合与治疗效应的关系仍未知。这里保留不确定性，不把机制词变成个人疗效、剂量、联用或转换结论。", "en": "The NEURONTIN label says gabapentin's precise analgesic and antiepileptic mechanisms are unknown. In-vitro studies show high-affinity binding to the alpha-2-delta subunit of voltage-activated calcium channels, while the relationship to therapeutic effect remains unknown. This preserves uncertainty rather than turning mechanism terms into conclusions about individual response, dose, combination or switching." }, "checks": [ { "zh": "“α2δ 亚基”是标签中的实验和药理线索，不是任何疼痛、发作、头晕、睡眠改变或其他不适原因的诊断工具，也不能据此决定是否开始、增加、叠加或改用药物。", "en": "“Alpha-2-delta subunit” is an experimental and pharmacologic clue in a label, not a diagnostic tool for pain, a seizure, dizziness, sleep change or another concern, and it cannot decide whether to start, increase, combine or switch a medicine." }, { "zh": "与其他神经系统用药或镇痛药名称、用途或机制看似相关，不表示可以自行叠加、轮换、按 mg 换算或用余药续用。准确剂型、肾功能、完整药单和当前标签必须由专业人员一起评估。", "en": "A seeming relationship in name, use or mechanism with another nervous-system or pain medicine does not permit self-combination, alternation, milligram conversion or using leftovers. Exact dosage form, renal function, the complete medicine list and current label need professional review together." }, { "zh": "明显嗜睡、呼吸变慢或困难、面部／口唇／咽喉肿胀、持续或反复发作、意识改变或其他急性问题，应优先使用当地紧急医疗和既有照护渠道；机制页面不能替代现场评估。", "en": "With marked sleepiness, slowed or difficult breathing, face/lip/throat swelling, persistent or repeated seizures, altered consciousness or another acute concern, prioritise local emergency care and established care pathways; a mechanism page cannot replace in-person assessment." } ], "source": { "id": "src_001b52fb3a445c0f", "label": "DailyMed（NLM）：NEURONTIN 加巴喷丁当前美国公开标签（Viatris Specialty LLC；页面 2026-05-12 更新；处方信息 2025-04 修订；Clinical Pharmacology）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=97935fd9-1d4a-43b6-a5d9-de994591187b", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "Neurontin", "generic": "加巴喷丁", "dosageFormClass": "NEURONTIN 加巴喷丁：100 / 300 / 400 mg 口服胶囊、600 / 800 mg 薄膜衣刻痕片、250 mg/5 mL 口服溶液（美国公开标签所列；本页分别建立五种 100 单位瓶装与一瓶 470 mL 口服液身份，不将不同剂型、包装或其他市场合并）" }, "labelSource": { "id": "src_001b52fb3a445c0f", "label": "DailyMed（NLM）：NEURONTIN 加巴喷丁当前美国公开标签（Viatris Specialty LLC；页面 2026-05-12 更新；处方信息 2025-04 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=97935fd9-1d4a-43b6-a5d9-de994591187b", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "productRoutes": [ { "source": { "id": "src_001b52fb3a445c0f", "label": "DailyMed（NLM）：NEURONTIN 加巴喷丁当前美国公开标签（Viatris Specialty LLC；页面 2026-05-12 更新；处方信息 2025-04 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=97935fd9-1d4a-43b6-a5d9-de994591187b", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-23", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-23", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [ { "id": "fda-2019-gabapentinoid-serious-breathing-gabapentin", "issuedAt": "2019-12-19", "status": "fda_class_safety_communication", "title": { "zh": "FDA 药物安全通讯：包括 Neurontin（gabapentin）在内的加巴喷丁类药物严重呼吸问题风险沟通", "en": "FDA Drug Safety Communication: serious breathing-problem warning for gabapentinoids including Neurontin (gabapentin)" }, "summary": { "zh": "FDA 于 2019-12-19 发布药物安全通讯，明确列出 Neurontin（gabapentin），并说明在存在呼吸风险因素时使用加巴喷丁类药物可能出现严重呼吸困难；公告所列背景包括与阿片类镇痛药或其他中枢神经系统抑制药同用、降低肺功能的疾病及高龄。FDA 要求在美国加巴喷丁类药物处方信息中增加呼吸抑制风险警语。该记录是美国、特定日期的类别监管沟通，不表示手中任何 Neurontin 包装、其他剂型或市场、任何联用，或任何个人已发生问题，也不支持自行停药、减量、加量、换药或把 Neurontin 与其他镇静性药物自行叠加／拆分。出现呼吸困难、反应异常、难以唤醒或其他紧急症状时应立即使用当地急救服务；非紧急的联用或风险问题应连同实际包装和完整药单由开方团队或药师核对。", "en": "On 2019-12-19, FDA issued a Drug Safety Communication that explicitly lists Neurontin (gabapentin) and says serious breathing difficulties may occur with gabapentinoids in people with respiratory risk factors. The communication names use with opioid pain medicines or other central-nervous-system depressants, conditions that reduce lung function, and older age as context; FDA required respiratory-depression warnings in U.S. gabapentinoid prescribing information. This is a dated U.S. class regulatory communication. It does not mean that any Neurontin pack, another dosage form or market, any combination, or any individual has a problem, and it does not support self-stopping, reducing, increasing, switching, or independently adding/splitting Neurontin with another sedating medicine. Trouble breathing, unusual unresponsiveness, inability to wake, or another emergency requires local emergency services; non-emergency combination or risk questions need the actual pack and complete medicine list reviewed by a pharmacist or prescribing team." }, "source": { "id": "src_d155de4d5f6093e9", "label": "FDA：2019-12-19 加巴喷丁／普瑞巴林（含 Neurontin、Lyrica）严重呼吸问题药物安全通讯", "url": "https://www.fda.gov/safety/medical-product-safety-information/neurontin-gralise-horizant-gabapentin-and-lyrica-lyrica-cr-pregabalin-drug-safety-communication", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "DailyMed 当前美国公开标签列有 NEURONTIN（gabapentin）的三种胶囊、两种刻痕片和一种口服溶液。本页分别建立准确包装的品牌、通用名、单位标示量、NDC、外观线索和一手来源核对卡；不把包装数字变成个人粒数、片数、毫升数、分割、转换、减停、联用、转换或购买结论。", "history": "本页只建立 DailyMed 当前美国公开标签所列的 NEURONTIN 100 mg 胶囊（NDC 58151-281-01）、300 mg 胶囊（58151-282-01）、400 mg 胶囊（58151-283-01）、600 mg 刻痕片（58151-284-01）、800 mg 刻痕片（58151-285-01）各 100 单位瓶装，以及 250 mg/5 mL 口服溶液（58151-290-35；470 mL 瓶装）身份。胶囊、刻痕片和液体浓度不能按同一通用名、相近 mg 或包装数字凭经验互换；实际计划需由开方团队按现行标签和个人资料核对。", "sourceDocuments": [ { "id": "src_001b52fb3a445c0f", "label": "DailyMed（NLM）：NEURONTIN 加巴喷丁当前美国公开标签（Viatris Specialty LLC；页面 2026-05-12 更新；处方信息 2025-04 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=97935fd9-1d4a-43b6-a5d9-de994591187b", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" } ], "applicationNumber": "NDA 020235 / 020882 / 021129（当前 DailyMed NEURONTIN 标签所列）", "approvalTimeline": [ { "date": "1993", "title": { "zh": "FDA 标签所列美国初始批准年份", "en": "Initial U.S. approval year listed in the FDA label" }, "detail": { "zh": "本页链接的 FDA 标签档案列示 Initial U.S. Approval: 1993。该历史定位不等同于当前批准、可得性、持有人或其他市场状态。", "en": "The FDA label archive linked here lists Initial U.S. Approval: 1993. This historical locator is not a conclusion about current approval, availability, holder or another market." }, "source": { "id": "src_001b52fb3a445c0f", "label": "DailyMed: NEURONTIN current U.S. label", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=97935fd9-1d4a-43b6-a5d9-de994591187b", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" } }, { "date": "2026-05-12", "title": { "zh": "FDA 标签档案版本", "en": "FDA label archive version" }, "detail": { "zh": "本页链接 2026-05-12 的 FDA 标签档案作为可复核阅读入口。现行标签、规格、适应症和安全信息必须另行以目标市场当前文件核对。", "en": "This page links the 2026-05-12 FDA label archive as a traceable reading entry point. Current labeling, strength, indication and safety information require separate verification against the target market’s current document." }, "source": { "id": "src_001b52fb3a445c0f", "label": "DailyMed: NEURONTIN current U.S. label", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=97935fd9-1d4a-43b6-a5d9-de994591187b", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "已链接公开标签档案", "en": "Public label archive linked" }, "detail": { "zh": "仅对应本页所列 FDA 文件。", "en": "Only the FDA document listed on this page is linked." } }, { "market": { "zh": "中国大陆、欧盟、日本", "en": "Mainland China, EU, Japan" }, "status": { "zh": "待逐项建立市场记录", "en": "Market record not established" }, "detail": { "zh": "不从美国标签档案推定当地批准、持有人、规格、供应或可售资格。", "en": "No local approval, holder, strength, supply or sale-eligibility conclusion is inferred from the U.S. label archive." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "标签档案能代表现在的产品信息吗？", "en": "Does a label archive represent current product information?" }, "answer": { "zh": "不能自动代表。档案用于定位来源；需要以目标市场的现行官方标签逐项复核。", "en": "Not automatically. The archive locates a source; each point needs verification against the target market’s current official label." } }, { "question": { "zh": "为什么这里不展示价格或原研/仿制结论？", "en": "Why are price and originator/generic conclusions not shown?" }, "answer": { "zh": "这些结论需要产品、剂型、规格、包装、市场、日期和原始记录分别齐全并经人工审核；单一标签文件不足以支持。", "en": "Those conclusions require separately complete and human-reviewed product, dosage-form, strength, pack, market, date and primary-record fields; one label file is insufficient." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "how-to-read-a-drug-label", "regulatory-sources-first" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/neurontin/", "en": "https://origindrug.com/en/drugs/neurontin/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "tegretol", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-23", "status": "published_traceable_archive" }, "names": { "brand": "Tegretol", "generic": "卡马西平", "aliases": [ "TEGRETOL", "Tegretol-XR", "carbamazepine", "卡马西平" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "神经与认知", "sourceArchiveMarket": "美国 DailyMed 当前 TEGRETOL / TEGRETOL-XR（carbamazepine）公开标签，2026-07-15 生效。本档案只核对该标签列出的普通片、XR 缓释片、混悬液及所选 NDC 包装展示面；不推定中国大陆或其他市场的当前批准、商品名、供应、可售资格、原研/仿制关系或个人适用性。", "dosageFormClass": "TEGRETOL 200 mg 口服片；TEGRETOL-XR 缓释口服片：100 mg、200 mg、400 mg；另有 100 mg/5 mL 口服混悬液（DailyMed 美国公开标签所列）", "dosageFormClassCode": "oral_modified_release", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "美国公开标签版本：2026-07-15（不作为全球批准史结论）", "archiveSponsorText": "Novartis Pharmaceuticals Corporation / DailyMed 美国公开标签" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [ "carbamazepine chewable tablet", "CARBATROL", "EQUETRO", "其他市场的卡马西平产品" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-tegretol-carbamazepine-tablet-200mg-100bottle-ndc-0078-0509-05", "marketCode": "US", "labelVersion": { "zh": "DailyMed 美国公开标签（2026-07-15 生效）", "en": "U.S. DailyMed public label (effective 15 Jul 2026)" }, "dosageForm": { "zh": "TEGRETOL 卡马西平口服片", "en": "TEGRETOL carbamazepine oral tablet" }, "route": { "zh": "口服（标签产品身份字段）", "en": "oral (label product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 0078-0509-05", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片 200 mg；100 片瓶装", "en": "200 mg per tablet; 100-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=tegretol-04.jpg&id=967961", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "卡马西平", "en": "carbamazepine" }, "value": 200, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、疗程或换算", "en": "labelled amount per tablet; not an individual's tablet count, course or conversion" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-23", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_038fe98dc4c00529", "label": "DailyMed（NLM）：TEGRETOL / TEGRETOL-XR 卡马西平美国公开标签（Novartis；2026-07-15 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8d409411-aa9f-4f3a-a52c-fbcb0c3ec053", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-tegretol-carbamazepine-xr-tablet-100mg-100bottle-ndc-0078-0510-05", "marketCode": "US", "labelVersion": { "zh": "DailyMed 美国公开标签（2026-07-15 生效）", "en": "U.S. DailyMed public label (effective 15 Jul 2026)" }, "dosageForm": { "zh": "TEGRETOL-XR 卡马西平缓释口服片", "en": "TEGRETOL-XR carbamazepine extended-release oral tablet" }, "route": { "zh": "口服（标签产品身份字段）", "en": "oral (label product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 0078-0510-05", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片 100 mg；100 片瓶装", "en": "100 mg per tablet; 100-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=tegretol-05.jpg&id=967961", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "卡马西平", "en": "carbamazepine" }, "value": 100, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、疗程或换算", "en": "labelled amount per tablet; not an individual's tablet count, course or conversion" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-23", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_038fe98dc4c00529", "label": "DailyMed（NLM）：TEGRETOL / TEGRETOL-XR 卡马西平美国公开标签（Novartis；2026-07-15 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8d409411-aa9f-4f3a-a52c-fbcb0c3ec053", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-tegretol-carbamazepine-xr-tablet-200mg-100bottle-ndc-0078-0511-05", "marketCode": "US", "labelVersion": { "zh": "DailyMed 美国公开标签（2026-07-15 生效）", "en": "U.S. DailyMed public label (effective 15 Jul 2026)" }, "dosageForm": { "zh": "TEGRETOL-XR 卡马西平缓释口服片", "en": "TEGRETOL-XR carbamazepine extended-release oral tablet" }, "route": { "zh": "口服（标签产品身份字段）", "en": "oral (label product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 0078-0511-05", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片 200 mg；100 片瓶装", "en": "200 mg per tablet; 100-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=tegretol-01.jpg&id=967961", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "卡马西平", "en": "carbamazepine" }, "value": 200, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、疗程或换算", "en": "labelled amount per tablet; not an individual's tablet count, course or conversion" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-23", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_038fe98dc4c00529", "label": "DailyMed（NLM）：TEGRETOL / TEGRETOL-XR 卡马西平美国公开标签（Novartis；2026-07-15 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8d409411-aa9f-4f3a-a52c-fbcb0c3ec053", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-tegretol-carbamazepine-xr-tablet-400mg-100bottle-ndc-0078-0512-05", "marketCode": "US", "labelVersion": { "zh": "DailyMed 美国公开标签（2026-07-15 生效）", "en": "U.S. DailyMed public label (effective 15 Jul 2026)" }, "dosageForm": { "zh": "TEGRETOL-XR 卡马西平缓释口服片", "en": "TEGRETOL-XR carbamazepine extended-release oral tablet" }, "route": { "zh": "口服（标签产品身份字段）", "en": "oral (label product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 0078-0512-05", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片 400 mg；100 片瓶装", "en": "400 mg per tablet; 100-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=tegretol-03.jpg&id=967961", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "卡马西平", "en": "carbamazepine" }, "value": 400, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、疗程或换算", "en": "labelled amount per tablet; not an individual's tablet count, course or conversion" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-23", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_038fe98dc4c00529", "label": "DailyMed（NLM）：TEGRETOL / TEGRETOL-XR 卡马西平美国公开标签（Novartis；2026-07-15 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8d409411-aa9f-4f3a-a52c-fbcb0c3ec053", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-tegretol-carbamazepine-tablet-200mg-100bottle-ndc-0078-0509-05", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=tegretol-04.jpg&id=967961", "alt": "TEGRETOL 卡马西平美国 DailyMed 公开标签中的 200 mg、NDC 0078-0509-05、100 片瓶装展示面", "archiveMarket": "美国", "labelVersion": "DailyMed 美国公开标签（Novartis，2026-07-15 生效）", "presentation": "TEGRETOL 卡马西平 200 mg 口服片；NDC 0078-0509-05；100 片瓶装。", "notice": "此图只对应美国 DailyMed 公开标签中的 TEGRETOL 卡马西平 200 mg 口服片、NDC 0078-0509-05、100 片瓶装。它不代表 TEGRETOL-XR 100/200/400 mg 缓释片、100 mg/5 mL 口服混悬液、其他包装、其他市场或当前可得性；不用于鉴定真伪，也不提供个人片数、毫升数、掰开、研碎、替换或调整建议。", "source": { "id": "src_038fe98dc4c00529", "label": "DailyMed（NLM）：TEGRETOL / TEGRETOL-XR 卡马西平美国公开标签（Novartis；2026-07-15 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8d409411-aa9f-4f3a-a52c-fbcb0c3ec053", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "TEGRETOL 说明书放大阅读：普通片、XR 缓释片与口服混悬液不能按名称或 mg 自行换算", "en": "TEGRETOL label reading: standard tablets, XR tablets and oral suspension cannot be self-converted by name or milligrams" }, "summary": { "zh": "本模块以美国 DailyMed 公开标签为阅读入口，帮助核对 TEGRETOL、TEGRETOL-XR、卡马西平、准确剂型、每单位标示量、NDC 和包装。它不提供任何人的片数、毫升数、间隔、漏用处理、联用、转换或停药方案。", "en": "This module uses the U.S. DailyMed public label to check TEGRETOL, TEGRETOL-XR, carbamazepine, the exact form, labelled amount per unit, NDC and package. It does not provide anyone's tablet count, millilitres, interval, missed-use action, combination, conversion or stopping plan." }, "checks": [ { "zh": "TEGRETOL 200 mg 普通口服片、TEGRETOL-XR 100/200/400 mg 缓释口服片和每 5 mL 含 100 mg 的口服混悬液，是标签分别列出的产品身份。相同品牌或通用名不能使它们自行按 mg、片数或 mL 换算、补用、叠加或替代。", "en": "The 200 mg TEGRETOL standard oral tablet, 100/200/400 mg TEGRETOL-XR extended-release oral tablets and oral suspension containing 100 mg per 5 mL are separately listed product identities. A shared brand or generic name does not make them self-convertible, make-up interchangeable, combinable or substitutable by milligrams, tablets or millilitres." }, { "zh": "这份标签为 TEGRETOL-XR 写明应整片吞服，不能压碎或咀嚼。该句只对应这款准确美国缓释片，不给本网页对任何其他卡马西平产品、普通片、液体或别的药品作出掰开、压碎、混合或替代许可；实际处理须以现行标签、处方和药师/开方团队为准。", "en": "This label states that TEGRETOL-XR should be swallowed whole and must not be crushed or chewed. That wording applies only to this exact U.S. extended-release tablet; it does not give this webpage permission to split, crush, mix or substitute any other carbamazepine product, standard tablet, liquid or medicine. Actual handling must follow the current label, prescription and pharmacist/prescribing-team advice." }, { "zh": "标签的黑框警告提示：具有遗传风险人群祖源的个人，在开始用药前应进行 HLA-B*1502 筛查。它不等于每个人都要做广泛基因检测，亦不能由网页推断个人祖源、检测项目、结果含义或是否能开始、继续、暂停或换药；应由开方团队、药师或遗传专业人员按实际情况解释。", "en": "The boxed warning states that people with ancestry in genetically at-risk populations should be screened for HLA-B*1502 before starting treatment. This does not mean everyone needs broad genetic testing, nor can a webpage infer an individual's ancestry, test choice, result meaning or whether to start, continue, pause or switch; the prescribing team, pharmacist or genetics professional must interpret the actual context." }, { "zh": "新的或进行性皮疹、水疱、口腔溃疡、发热、面部肿胀、黄疸样变化、明显嗜睡/意识改变、晕厥或其他急性问题，应及时联系当地医疗支持；不要仅因担心不良反应而依据网页自行补用、加量、骤停或换成另一种产品。", "en": "With a new or progressive rash, blistering, mouth sores, fever, facial swelling, jaundice-like changes, marked drowsiness/mental-status change, fainting or another acute concern, contact local medical support promptly. Do not self-make-up, increase, abruptly stop or change to another product from this webpage because of an adverse-effect concern." } ], "source": { "id": "src_038fe98dc4c00529", "label": "DailyMed（NLM）：TEGRETOL / TEGRETOL-XR 卡马西平美国公开标签（Novartis；2026-07-15 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8d409411-aa9f-4f3a-a52c-fbcb0c3ec053", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "卡马西平怎样起作用：标签中的抗惊厥药理信息不等于个人调整依据", "en": "How carbamazepine works: anticonvulsant pharmacology in a label is not a basis for individual adjustment" }, "summary": { "zh": "DailyMed 标签将卡马西平列为抗惊厥药，并说明其发挥抗惊厥作用的确切机制尚不清楚。本页只帮助读者理解标签中的药理边界；它不判断任何人的症状原因、适应情形、产品选择、片数、毫升数、联用或调整方案。", "en": "The DailyMed label classifies carbamazepine as an anticonvulsant and states that the exact mechanism by which it exerts anticonvulsant activity is unknown. This page only explains the label's pharmacology boundary; it does not determine anyone's symptom cause, use context, product choice, tablet count, millilitres, combination or adjustment plan." }, "checks": [ { "zh": "“抗惊厥药”不是对任何抽搐、疼痛、头晕、情绪或神经系统症状的自我诊断，也不能替代由专业人员结合准确产品、病情和检查资料作出的判断。", "en": "“Anticonvulsant” is not a self-diagnosis for any seizure, pain, dizziness, mood or neurologic symptom and cannot replace professional judgement based on the exact product, condition and clinical information." }, { "zh": "共享通用名、作用类别或同为口服产品，不使普通片、缓释片、混悬液或另一种神经系统相关药物可以自行叠加、轮换、按 mg 换算或替代。完整药单和现行标签必须一起复核。", "en": "A shared generic name, pharmacologic class or oral route does not make standard tablets, extended-release tablets, suspension or another neurologic medicine self-combinable, alternatable, milligram-convertible or substitutable. The complete medicine list and current labels require joint review." }, { "zh": "机制页面不能处理突然或加重的抽搐、严重皮疹、意识改变、呼吸困难、晕厥或其他急性不适。出现这类问题时，应优先使用当地紧急医疗支持，而不是继续试验不同剂型或根据包装数字自行调整。", "en": "A mechanism page cannot manage sudden or worsening seizures, severe rash, mental-status change, breathing difficulty, fainting or another acute concern. With these problems, prioritise local urgent medical support rather than experimenting with forms or adjusting from package numbers." } ], "source": { "id": "src_038fe98dc4c00529", "label": "DailyMed（NLM）：TEGRETOL / TEGRETOL-XR 卡马西平美国公开标签（Novartis；2026-07-15 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8d409411-aa9f-4f3a-a52c-fbcb0c3ec053", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "Tegretol", "generic": "卡马西平", "dosageFormClass": "TEGRETOL 200 mg 口服片；TEGRETOL-XR 缓释口服片：100 mg、200 mg、400 mg；另有 100 mg/5 mL 口服混悬液（DailyMed 美国公开标签所列）" }, "labelSource": { "id": "src_038fe98dc4c00529", "label": "DailyMed（NLM）：TEGRETOL / TEGRETOL-XR 卡马西平美国公开标签（Novartis；2026-07-15 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8d409411-aa9f-4f3a-a52c-fbcb0c3ec053", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "productRoutes": [ { "source": { "id": "src_038fe98dc4c00529", "label": "DailyMed（NLM）：TEGRETOL / TEGRETOL-XR 卡马西平美国公开标签（Novartis；2026-07-15 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8d409411-aa9f-4f3a-a52c-fbcb0c3ec053", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-23", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-23", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "DailyMed 美国公开标签将 TEGRETOL 列为卡马西平 200 mg 口服片，将 TEGRETOL-XR 列为 100 mg、200 mg、400 mg 缓释口服片，并另列 100 mg/5 mL 口服混悬液。本页让读者逐项核对商品名、通用名、准确剂型、每单位标示量、NDC、包装展示面、说明书与药物警戒入口；mg 只用于药盒身份核对，不转换为个人片数、毫升数、开始、停用、联用、换药或购买结论。", "history": "该美国公开标签带有严重皮肤反应与 HLA-B*1502 相关黑框警告，并提示在具有遗传风险人群祖源的人群中应在开始前进行相应筛查。它并不等于所有人都需要进行广泛基因检测，也不能替代由开方团队、药师或遗传专业人员结合准确产品、祖源、病情和完整药单作出的判断。不同剂型、包装、市场或同通用名产品必须按实际药盒和目标市场现行资料分别核对。", "sourceDocuments": [ { "id": "src_038fe98dc4c00529", "label": "DailyMed（NLM）：TEGRETOL / TEGRETOL-XR 卡马西平美国公开标签（Novartis；2026-07-15 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8d409411-aa9f-4f3a-a52c-fbcb0c3ec053", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, { "id": "src_5ed30b676fbb9773", "label": "FDA Drugs@FDA 官方检索入口", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_lookup_entry", "documentKind": "regulatory_lookup", "market": "US", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } ], "applicationNumber": "DailyMed SPL setid 8d409411-aa9f-4f3a-a52c-fbcb0c3ec053（本档案不据此推定其他市场状态）", "approvalTimeline": [ { "date": "2026-07-15", "title": { "zh": "当前美国公开标签的生效日期", "en": "Effective date of the current U.S. public label" }, "detail": { "zh": "DailyMed 当前 TEGRETOL / TEGRETOL-XR 美国公开标签列示 2026-07-15 生效。本页仅用此文件核对其列出的普通片、XR 缓释片、口服混悬液、NDC 与包装展示面；不据此判断实际在售、库存、购买或个人使用安排。", "en": "The current DailyMed U.S. public label for TEGRETOL / TEGRETOL-XR lists an effective date of 15 Jul 2026. This page uses that document only to check its listed standard tablets, XR tablets, oral suspension, NDCs and package panels; it does not establish actual marketing, stock, purchase or an individual use plan." }, "source": { "id": "src_038fe98dc4c00529", "label": "DailyMed（NLM）：TEGRETOL / TEGRETOL-XR 卡马西平美国公开标签（Novartis；2026-07-15 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8d409411-aa9f-4f3a-a52c-fbcb0c3ec053", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "已链接当前公开标签与四个准确片剂瓶装展示面", "en": "Current public label and four exact tablet-bottle panels linked" }, "detail": { "zh": "本页展示 TEGRETOL 200 mg、NDC 0078-0509-05、100 片瓶装，以及 TEGRETOL-XR 100/200/400 mg、各 100 片瓶装的标签展示面。它们不用于鉴定真伪，也不建立实际在售、库存、购买、个人片数、毫升数、压碎/咀嚼、换药或可替代性。", "en": "This page displays label panels for TEGRETOL 200 mg, NDC 0078-0509-05, 100-tablet bottle and TEGRETOL-XR 100/200/400 mg, each in a 100-tablet bottle. They do not authenticate a product or establish actual marketing, stock, purchase, individual tablet count, millilitres, crushing/chewing, switching or interchangeability." } }, { "market": { "zh": "中国大陆、欧盟、日本及其他市场", "en": "Mainland China, EU, Japan and other markets" }, "status": { "zh": "待逐项建立现行市场记录", "en": "Current market record not established" }, "detail": { "zh": "不从美国标签、SPL、NDC、英文商品名、包装图或标签持有人推定当地商品名、批准、包装、供应、可售资格、原研/仿制关系或可替代性；每个市场均须按当地现行监管资料单独核对。", "en": "No local trade name, approval, packaging, supply, sale eligibility, originator/generic relationship or interchangeability is inferred from the U.S. label, SPL, NDC, English brand, package image or label holder; every market requires separate checking against current local regulatory material." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "TEGRETOL、TEGRETOL-XR 和口服混悬液都写卡马西平，能否按 mg 自行换用？", "en": "TEGRETOL, TEGRETOL-XR and oral suspension all say carbamazepine. Can they be self-switched by milligrams?" }, "answer": { "zh": "不能。准确剂型、每单位标示量、包装、标签版本、市场和处方都属于产品身份的一部分。共享通用名或相近 mg 数不建立换算或替代关系；请将实际产品和完整药单交给药师或开方团队核对。", "en": "No. The exact dosage form, labelled amount per unit, package, label version, market and prescription are all parts of product identity. A shared generic name or similar milligram amount does not create a conversion or substitution relationship; take the actual product and full medicine list to a pharmacist or prescribing team." } }, { "question": { "zh": "标签提到 HLA-B*1502，是否每个人都应做基因检测？", "en": "The label mentions HLA-B*1502. Does everyone need genetic testing?" }, "answer": { "zh": "不能从网页得出“所有人都需要”的结论。该标签针对具有遗传风险人群祖源的开始用药前筛查提示，实际是否筛查、筛什么、如何解释结果应由开方团队、药师或遗传专业人员结合个人背景和准确产品说明。", "en": "A webpage cannot conclude that everyone needs testing. The label's pre-treatment screening notice concerns people with ancestry in genetically at-risk populations; whether to test, what to test and how to interpret a result require the prescribing team, pharmacist or genetics professional to consider the individual's context and exact product." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "dosage-forms-are-part-of-medicine-identity", "how-to-read-a-drug-label" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/tegretol/", "en": "https://origindrug.com/en/drugs/tegretol/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "namenda", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-09-04", "status": "published_traceable_archive" }, "names": { "brand": "NAMENDA", "generic": "盐酸美金刚", "aliases": [ "NAMENDA", "memantine", "memantine hydrochloride", "盐酸美金刚", "Lupin memantine", "ANDA 090051", "68180-229-07", "68180-230-07" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "神经与认知", "sourceArchiveMarket": "美国：NAMENDA 历史原品牌标签列示 2025-10-31 营销结束；另展示 Lupin ANDA 090051 当前仿制药标签中的 5 mg、10 mg 两个准确 60 片瓶装。两个层级分开阅读，不由仿制药图反推原品牌外观、当前供应或可替代性。", "dosageFormClass": "口服薄膜衣片：历史 NAMENDA 5 mg／10 mg 两个 60 片瓶装文字身份；当前 Lupin 仿制药 5 mg／10 mg 两个 60 片瓶装与官方标签图，均按产品与 NDC 分开展示", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "2003（历史美国标签所列 Initial U.S. Approval）", "archiveSponsorText": "Allergan, Inc.（NAMENDA 历史品牌标签）／Lupin Pharmaceuticals, Inc.（当前仿制药比较标签）／DailyMed（NLM）" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [ "NAMENDA XR", "memantine extended release", "memantine oral solution", "NAMZARIC" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-namenda-tablet-5mg-ndc-0456-3205-60", "marketCode": "US", "labelVersion": { "zh": "历史公开标签：页面 2018-11-01 更新；SPL v19 于 2024-12-20 发布", "en": "Historical public label: page updated 1 Nov 2018; SPL v19 published 20 Dec 2024" }, "dosageForm": { "zh": "口服薄膜衣片", "en": "film-coated oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [], "productCode": "NDC 0456-3205-60", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片盐酸美金刚 5 mg；60 片瓶装", "en": "Memantine hydrochloride 5 mg per tablet; 60-tablet bottle" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "盐酸美金刚", "en": "memantine hydrochloride" }, "value": 5, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标示量", "en": "labelled amount per tablet" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 60, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": null, "package": { "count": 60, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "棕褐色", "en": "tan" }, "shape": { "zh": "胶囊形片", "en": "capsule-shaped tablet" }, "imprint": "5 / FL", "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_0ae3887eddde46aa", "label": "DailyMed（NLM）：NAMENDA 盐酸美金刚美国历史公开标签（Allergan；页面 2018-11-01 更新，SPL v19 于 2024-12-20 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b9f27baf-aa2a-443a-9ef5-e002d23407ba", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-namenda-tablet-10mg-ndc-0456-3210-60", "marketCode": "US", "labelVersion": { "zh": "历史公开标签：页面 2018-11-01 更新；SPL v19 于 2024-12-20 发布", "en": "Historical public label: page updated 1 Nov 2018; SPL v19 published 20 Dec 2024" }, "dosageForm": { "zh": "口服薄膜衣片", "en": "film-coated oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [], "productCode": "NDC 0456-3210-60", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片盐酸美金刚 10 mg；60 片瓶装", "en": "Memantine hydrochloride 10 mg per tablet; 60-tablet bottle" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "盐酸美金刚", "en": "memantine hydrochloride" }, "value": 10, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标示量", "en": "labelled amount per tablet" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 60, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": null, "package": { "count": 60, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "灰色", "en": "gray" }, "shape": { "zh": "胶囊形片", "en": "capsule-shaped tablet" }, "imprint": "10 / FL", "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_0ae3887eddde46aa", "label": "DailyMed（NLM）：NAMENDA 盐酸美金刚美国历史公开标签（Allergan；页面 2018-11-01 更新，SPL v19 于 2024-12-20 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b9f27baf-aa2a-443a-9ef5-e002d23407ba", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-lupin-memantine-hydrochloride-5mg-60-tablet-bottle-ndc-6818022907", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国 ANDA 仿制药标签（患者信息 2025-08 修订；SPL 2025-12-29）", "en": "Current U.S. DailyMed ANDA generic label (patient information revised Aug 2025; SPL 29 Dec 2025)" }, "dosageForm": { "zh": "盐酸美金刚薄膜衣口服片（仿制药比较项；非 NAMENDA 原品牌包装）", "en": "memantine hydrochloride film-coated oral tablet (generic comparator; not a NAMENDA originator-brand pack)" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 68180-229-07", "pouchCode": null, "applicationNumber": "ANDA 090051", "presentationRole": "generic_comparator_not_originator_brand", "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片盐酸美金刚 5 mg；60 片瓶装", "en": "Memantine hydrochloride 5 mg per tablet; 60-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=392d48fd-7c93-40f3-9ab0-d0f304b7e439-11.jpg&setid=1b4a0162-9cb4-4ba6-8c02-95c2955734ae&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "盐酸美金刚", "en": "memantine hydrochloride" }, "value": 5, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、递增或换药指令", "en": "labelled amount per tablet; not an individual's tablet count, titration or switching instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "60 片处方药瓶装标签展示面", "en": "60-tablet prescription bottle label panel" }, "fill": null, "countPerPackage": 60, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-04", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 60, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "棕褐色", "en": "tan" }, "shape": { "zh": "胶囊形、双凸薄膜衣片", "en": "capsule-shaped, biconvex film-coated tablet" }, "imprint": "LU / W01", "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_b5e03ac68dbf696a", "label": "DailyMed（NLM）：Lupin 盐酸美金刚片当前美国 ANDA 090051 仿制药标签与准确瓶装展示面", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=1b4a0162-9cb4-4ba6-8c02-95c2955734ae", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-lupin-memantine-hydrochloride-10mg-60-tablet-bottle-ndc-6818023007", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国 ANDA 仿制药标签（患者信息 2025-08 修订；SPL 2025-12-29）", "en": "Current U.S. DailyMed ANDA generic label (patient information revised Aug 2025; SPL 29 Dec 2025)" }, "dosageForm": { "zh": "盐酸美金刚薄膜衣口服片（仿制药比较项；非 NAMENDA 原品牌包装）", "en": "memantine hydrochloride film-coated oral tablet (generic comparator; not a NAMENDA originator-brand pack)" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 68180-230-07", "pouchCode": null, "applicationNumber": "ANDA 090051", "presentationRole": "generic_comparator_not_originator_brand", "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片盐酸美金刚 10 mg；60 片瓶装", "en": "Memantine hydrochloride 10 mg per tablet; 60-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=392d48fd-7c93-40f3-9ab0-d0f304b7e439-13.jpg&setid=1b4a0162-9cb4-4ba6-8c02-95c2955734ae&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "盐酸美金刚", "en": "memantine hydrochloride" }, "value": 10, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、递增或换药指令", "en": "labelled amount per tablet; not an individual's tablet count, titration or switching instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "60 片处方药瓶装标签展示面", "en": "60-tablet prescription bottle label panel" }, "fill": null, "countPerPackage": 60, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-04", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 60, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "灰色", "en": "gray" }, "shape": { "zh": "胶囊形、双凸薄膜衣片", "en": "capsule-shaped, biconvex film-coated tablet" }, "imprint": "LU / W02", "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_b5e03ac68dbf696a", "label": "DailyMed（NLM）：Lupin 盐酸美金刚片当前美国 ANDA 090051 仿制药标签与准确瓶装展示面", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=1b4a0162-9cb4-4ba6-8c02-95c2955734ae", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "status": "withheld_repackaged_or_non_exact_visual", "title": { "zh": "NAMENDA 历史原品牌图仍不展示；当前仿制药包装图另行标识", "en": "Historical NAMENDA originator-brand images remain withheld; current generic images are identified separately" }, "summary": { "zh": "NAMENDA 的历史 DailyMed 标签可追溯商品名、5 mg／10 mg、两个历史 NDC、60 片瓶装与美国营销结束日期，但未保留可用的一一对应原品牌公开图，因此不展示原品牌包装图，只保留文字身份。页面新增的两张图明确属于 Lupin ANDA 090051 当前仿制药 NDC 68180-229-07 与 68180-230-07，不得被理解为 NAMENDA 原品牌外观、真伪证明或换药依据。", "en": "The historical NAMENDA DailyMed label traces the trade name, 5 mg/10 mg, two historical NDCs, 60-tablet bottles and the U.S. marketing-end date, but no usable one-to-one public originator-brand image was retained, so originator-brand package images are not shown and those packs remain text-only. The two newly shown images explicitly belong to current Lupin ANDA 090051 generic NDC 68180-229-07 and 68180-230-07; they must not be read as NAMENDA originator-brand appearance, authentication or a switching basis." }, "source": { "id": "src_0ae3887eddde46aa", "label": "DailyMed（NLM）：NAMENDA 盐酸美金刚美国历史公开标签（Allergan；页面 2018-11-01 更新，SPL v19 于 2024-12-20 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b9f27baf-aa2a-443a-9ef5-e002d23407ba", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "NAMENDA／盐酸美金刚说明书放大阅读：先分历史原品牌与当前仿制药", "en": "NAMENDA / memantine label reading: separate the historical originator brand from a current generic first" }, "summary": { "zh": "本模块并列但不混合两类来源：NAMENDA 历史品牌标签，以及 Lupin 当前仿制药标签与电子说明书。5 mg、10 mg、NDC、60 片和外形只用于核对准确产品；页面不提供个人片数、递增、漏用补救、开始、停用、联用、换药或购买方案。", "en": "This module places two source layers side by side without merging them: the historical NAMENDA brand label and the current Lupin generic label with its electronic leaflet. The 5 mg, 10 mg, NDC, 60-tablet count and appearance identify an exact product only; the page provides no individual tablet count, titration, missed-use remedy, initiation, stopping, co-use, switching or purchase plan." }, "checks": [ { "zh": "先同时核对 NAMENDA、盐酸美金刚、5 mg 或 10 mg、NDC、口服薄膜衣片和目标市场。共有品牌或通用名，不证明另一强度、NAMENDA XR、口服溶液、复方产品或另一市场的产品可以互换。", "en": "Check NAMENDA, memantine hydrochloride, 5 mg or 10 mg, NDC, film-coated oral-tablet form and target market together. A shared brand or generic name does not prove that another strength, NAMENDA XR, an oral solution, a combination product or another-market product is interchangeable." }, { "zh": "5 mg、10 mg 和“60 片瓶装”是这两个历史标签面板的身份文字，不是每天该吃几片、何时加减、是否漏用补回或是否可以掰开的说明。任何实际使用问题应带着现行药盒、处方和完整药单请药师或开方团队核对。", "en": "The 5 mg, 10 mg and “60-tablet bottle” wording identifies these two historical label panels; it does not say how many tablets to use, when to change, whether to make up a missed use or whether splitting is appropriate. Take the current pack, prescription and full medicine list to a pharmacist or prescribing team for any actual-use question." }, { "zh": "标签中的不良反应和相互作用段落用于提出问题，不用于网页判断某个不适是否由这款药造成。尤其在高龄、多病共存或多药并用时，不要因头晕、困惑、便秘、尿液酸碱相关提示或包装数字自行停用、叠加、轮换或调整。", "en": "Adverse-reaction and interaction sections of the label help frame questions; they do not let a webpage determine the cause of a symptom. Especially with older age, multiple conditions or multiple medicines, do not self-stop, combine, alternate or adjust because of dizziness, confusion, constipation, urine-pH-related wording or package numbers." }, { "zh": "当前仿制药瓶上的 Lupin、NDC 68180-229-07 或 68180-230-07、LU/W01 或 LU/W02 与官方图可帮助核对手中药瓶，但不能当作 NAMENDA 原品牌包装图。照护者应把药瓶、处方、全部其他药物与补充剂一起核对，尤其不要把普通片、缓释胶囊、口服液或 NAMZARIC 复方按毫克数自行拼接或替换。", "en": "Lupin, NDC 68180-229-07 or 68180-230-07, LU/W01 or LU/W02 and the official current generic label images can help check a bottle in hand, but they are not NAMENDA originator-brand pack images. A caregiver should review the bottle, prescription, all other medicines and supplements together, and must not assemble or substitute an immediate-release tablet, extended-release capsule, oral solution or NAMZARIC combination by comparing milligram numbers." } ], "source": { "id": "src_0ae3887eddde46aa", "label": "DailyMed（NLM）：NAMENDA 盐酸美金刚美国历史公开标签（Allergan；页面 2018-11-01 更新，SPL v19 于 2024-12-20 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b9f27baf-aa2a-443a-9ef5-e002d23407ba", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "盐酸美金刚怎样起作用：历史标签把它描述为 NMDA 受体拮抗剂", "en": "How memantine hydrochloride works: the historical label describes an NMDA-receptor antagonist" }, "summary": { "zh": "这份历史标签在临床药理部分将盐酸美金刚描述为 NMDA 受体拮抗剂。它解释的是标签用语中的一个药物作用路径，不预测任何个人的认知变化、适用性、疗程、片数或联用方案。", "en": "In Clinical Pharmacology, this historical label describes memantine hydrochloride as an NMDA-receptor antagonist. It explains one drug-action pathway in the label; it does not predict an individual's cognitive change, suitability, course, tablet count or co-use plan." }, "checks": [ { "zh": "NMDA 是一种受体名称；“拮抗剂”描述药物与该受体相关作用的方向。这个机制词不能单独说明某个人是否适合、何时见效、应持续多久或是否应更换产品。", "en": "NMDA is the name of a receptor, and “antagonist” describes the direction of a drug's related action. This mechanism term alone cannot tell whether a person is suitable, when an effect will occur, how long use should continue or whether a product should be changed." }, { "zh": "同为“认知”相关药物、标签中出现相近术语，或共同出现于一张药单，都不建立可以自行合并、轮换或替代的关系。应让专业人员按准确产品、目标市场现行标签、既往反应和完整药单复核。", "en": "Being described as cognition-related, having similar label terms or appearing on the same medicine list does not establish that products can be self-combined, alternated or substituted. A professional should review the exact products, current target-market labels, prior reactions and full medicine list." }, { "zh": "若照护者发现明显的急性变化、跌倒风险、意识改变或不确定怎样处理，应使用当地紧急与专业渠道；不要把机制说明或历史标签当作自行加减、停用或补用的规则。", "en": "If a caregiver notices a marked acute change, fall risk, altered consciousness or uncertainty about what to do, use local urgent and professional care pathways; do not use a mechanism explanation or historical label as a rule for self-adjusting, stopping or making up use." } ], "source": { "id": "src_0ae3887eddde46aa", "label": "DailyMed（NLM）：NAMENDA 盐酸美金刚美国历史公开标签（Clinical Pharmacology；Allergan）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b9f27baf-aa2a-443a-9ef5-e002d23407ba", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "NAMENDA", "generic": "盐酸美金刚", "dosageFormClass": "口服薄膜衣片：历史 NAMENDA 5 mg／10 mg 两个 60 片瓶装文字身份；当前 Lupin 仿制药 5 mg／10 mg 两个 60 片瓶装与官方标签图，均按产品与 NDC 分开展示" }, "labelSource": { "id": "src_0ae3887eddde46aa", "label": "DailyMed（NLM）：NAMENDA 盐酸美金刚美国历史公开标签（Allergan；页面 2018-11-01 更新，SPL v19 于 2024-12-20 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b9f27baf-aa2a-443a-9ef5-e002d23407ba", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "productRoutes": [ { "source": { "id": "src_0ae3887eddde46aa", "label": "DailyMed（NLM）：NAMENDA 盐酸美金刚美国历史公开标签（Allergan；页面 2018-11-01 更新，SPL v19 于 2024-12-20 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b9f27baf-aa2a-443a-9ef5-e002d23407ba", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_b5e03ac68dbf696a", "label": "DailyMed（NLM）：Lupin 盐酸美金刚片当前美国 ANDA 090051 仿制药标签与准确瓶装展示面", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=1b4a0162-9cb4-4ba6-8c02-95c2955734ae", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-09-04", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "NAMENDA 是盐酸美金刚的历史美国品牌档案：5 mg、10 mg 和两个 60 片瓶装只用于追溯已结束营销的原品牌记录。页面同时把当前 Lupin 仿制药的 5 mg 与 10 mg、准确 NDC、60 片瓶装及官方包装图单独列为比较项，帮助照护者核对手中现行药瓶。品牌史、当前仿制药与个人用法是三个不同问题；网页不根据毫克数、颜色或同成分关系决定片数、递增、停用、联用、轮换或替换。", "history": "美国历史标签列示 NAMENDA Initial U.S. Approval: 2003、NDA 021487、2003-10-16 营销起始与 2025-10-31 营销结束。当前 Lupin ANDA 090051 标签列示 5 mg、10 mg 两个 60 片瓶装并提供患者信息和包装图。页面保留这条从历史原品牌到当前仿制药比较项的时间线，但不把监管等效关系直接转成个体换药决定。", "sourceDocuments": [ { "id": "src_0ae3887eddde46aa", "label": "DailyMed（NLM）：NAMENDA 盐酸美金刚美国历史公开标签（Allergan；页面 2018-11-01 更新，SPL v19 于 2024-12-20 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b9f27baf-aa2a-443a-9ef5-e002d23407ba", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_b5e03ac68dbf696a", "label": "DailyMed（NLM）：Lupin 盐酸美金刚片当前美国 ANDA 090051 仿制药标签与准确瓶装展示面", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=1b4a0162-9cb4-4ba6-8c02-95c2955734ae", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" }, { "id": "src_e9d038c315c72fe7", "label": "DailyMed（NLM）：Lupin 盐酸美金刚片当前美国电子说明书 PDF", "url": "https://dailymed.nlm.nih.gov/dailymed/getFile.cfm?setid=1b4a0162-9cb4-4ba6-8c02-95c2955734ae&type=pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "electronic_label_pdf", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" } ], "applicationNumber": "NDA 021487", "approvalTimeline": [ { "date": "2003", "title": { "zh": "历史标签所列美国初始批准年份", "en": "Initial U.S. approval year listed in the historical label" }, "detail": { "zh": "这份 NAMENDA 历史公开标签列示 Initial U.S. Approval: 2003；它只定位该美国历史档案，不建立其他市场的批准、供应、可售资格、原研/仿制关系或个人适用性。", "en": "This historical NAMENDA public label lists Initial U.S. Approval: 2003. It locates this U.S. historical archive only; it does not establish approval, supply, sale eligibility, originator/generic relationship or individual suitability in another market." }, "source": { "id": "src_0ae3887eddde46aa", "label": "DailyMed（NLM）：NAMENDA 盐酸美金刚美国历史公开标签（Allergan；页面 2018-11-01 更新，SPL v19 于 2024-12-20 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b9f27baf-aa2a-443a-9ef5-e002d23407ba", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, { "date": "2003-10-16", "title": { "zh": "历史标签产品数据所列美国营销起始日期", "en": "U.S. marketing-start date listed in historical-label product data" }, "detail": { "zh": "历史标签产品数据列示 NAMENDA 片剂的美国营销起始日期为 2003-10-16。该日期是历史产品记录，不是现行可得性、库存、个人用药或其他市场状态的证明。", "en": "Historical-label product data list 16 Oct 2003 as the U.S. marketing-start date for NAMENDA tablets. This is a historical product record, not evidence of current availability, stock, individual use or another-market status." }, "source": { "id": "src_0ae3887eddde46aa", "label": "DailyMed（NLM）：NAMENDA 盐酸美金刚美国历史公开标签（Allergan；页面 2018-11-01 更新，SPL v19 于 2024-12-20 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b9f27baf-aa2a-443a-9ef5-e002d23407ba", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, { "date": "2025-10-31", "title": { "zh": "历史标签产品数据所列美国营销结束日期", "en": "U.S. marketing-end date listed in historical-label product data" }, "detail": { "zh": "该历史标签的产品数据列示美国营销结束日期为 2025-10-31；因此本页不将 NAMENDA 表述为当前可购、在售、可替代或仍在美国供应。任何现行产品问题须回到目标市场的现行监管资料和专业人员。", "en": "Product data in this historical label list 31 Oct 2025 as the U.S. marketing-end date. This page therefore does not describe NAMENDA as currently purchasable, marketed, interchangeable or still supplied in the United States. Questions about a current product require the current target-market regulatory record and a professional." }, "source": { "id": "src_0ae3887eddde46aa", "label": "DailyMed（NLM）：NAMENDA 盐酸美金刚美国历史公开标签（Allergan；页面 2018-11-01 更新，SPL v19 于 2024-12-20 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b9f27baf-aa2a-443a-9ef5-e002d23407ba", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, { "date": "2025-12-29", "title": { "zh": "Lupin 当前仿制药 SPL 列示两个准确 60 片瓶装", "en": "Current Lupin generic SPL lists two exact 60-tablet bottles" }, "detail": { "zh": "ANDA 090051 当前公开标签分别列示 5 mg／NDC 68180-229-07／LU-W01 与 10 mg／NDC 68180-230-07／LU-W02，并提供准确包装图和患者信息。它是现行仿制药比较项，不是 NAMENDA 原品牌包装或个体换药许可。", "en": "The current ANDA 090051 public label separately lists 5 mg / NDC 68180-229-07 / LU-W01 and 10 mg / NDC 68180-230-07 / LU-W02 with exact package images and patient information. It is a current generic comparator, not a NAMENDA originator-brand pack or permission for an individual switch." }, "source": { "id": "src_b5e03ac68dbf696a", "label": "DailyMed（NLM）：Lupin 盐酸美金刚片当前美国 ANDA 090051 仿制药标签与准确瓶装展示面", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=1b4a0162-9cb4-4ba6-8c02-95c2955734ae", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-04", "reviewedAt": "2026-09-04" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "NAMENDA 原品牌标签列示 2025-10-31 营销结束；Lupin 仿制药标签为当前比较项", "en": "The NAMENDA originator-brand label lists a marketing end of 31 Oct 2025; the Lupin generic label is a current comparator" }, "detail": { "zh": "NAMENDA 5 mg、10 mg 两个历史 60 片瓶装只保留文字身份，其历史标签产品数据列示美国营销结束日期为 2025-10-31；Lupin ANDA 090051 的两个当前 60 片瓶装另以准确 NDC、刻字和官方图展示。页面不把仿制药图冒充原品牌外观，也不据此建立库存、购买、换用或供应结论。", "en": "Two historical NAMENDA 60-tablet bottles at 5 mg and 10 mg retain text identity only, and product data in that historical label list a U.S. marketing end date of 31 Oct 2025. Two current Lupin ANDA 090051 60-tablet bottles are shown separately with exact NDCs, imprints and official images. The generic images are not presented as originator-brand appearance and do not establish stock, purchase, switching or supply." } }, { "market": { "zh": "中国大陆、欧盟、日本及其他市场", "en": "Mainland China, EU, Japan and other markets" }, "status": { "zh": "待逐项建立现行市场记录", "en": "Current market record not established" }, "detail": { "zh": "不从这份美国历史标签推定当地商品名、批准、包装、供应、可售资格、原研/仿制关系或可替代性；每个市场都须按当地现行监管资料单独核对。", "en": "No local trade name, approval, packaging, supply, sale eligibility, originator/generic relationship or interchangeability is inferred from this U.S. historical label; each market requires separate checking against current local regulatory material." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "NAMENDA 5 mg、10 mg 或 60 片瓶装，是否意味着可以自行调整片数、换到 NAMENDA XR 或和其他认知相关药轮换？", "en": "Do NAMENDA 5 mg, 10 mg or a 60-tablet bottle mean that tablet count can be self-adjusted, or that a person can switch to NAMENDA XR or alternate with another cognition-related medicine?" }, "answer": { "zh": "不能。这些文字只识别历史标签中的准确片剂和瓶装。共同品牌、通用名、领域或相近毫克数均不建立自行调整、掰开、补用、合并、轮换或替换关系；请带现行药盒、处方与完整药单请药师或开方团队复核。", "en": "No. These words only identify exact tablets and bottles in a historical label. A shared brand, generic name, therapeutic area or similar milligram number does not establish self-adjustment, splitting, make-up use, combining, alternating or substitution; take the current pack, prescription and complete medicine list to a pharmacist or prescribing team." } }, { "question": { "zh": "页面上的 Lupin 药瓶图是不是 NAMENDA 原研药包装？", "en": "Are the Lupin bottle images on this page NAMENDA originator-brand packages?" }, "answer": { "zh": "不是。它们是一份当前美国仿制药标签中与 NDC 68180-229-07、68180-230-07 一一对应的准确展示面，仅用于帮助核对现行仿制药瓶；NAMENDA 原品牌历史包装因没有保留可用的一一对应公开图，仍只展示文字身份。", "en": "No. They are exact panels tied to NDC 68180-229-07 and 68180-230-07 in a current U.S. generic label and only help check those generic bottles. The historical NAMENDA originator-brand packages remain text-only because no usable one-to-one public image was retained." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "dosage-forms-are-part-of-medicine-identity", "how-to-read-a-drug-label" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/namenda/", "en": "https://origindrug.com/en/drugs/namenda/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "namzaric", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-28", "status": "published_traceable_archive" }, "names": { "brand": "NAMZARIC", "generic": "盐酸美金刚/盐酸多奈哌齐（复方）", "aliases": [ "NAMZARIC", "memantine and donepezil hydrochlorides", "memantine hydrochloride and donepezil hydrochloride", "盐酸美金刚/盐酸多奈哌齐", "美金刚多奈哌齐复方缓释胶囊", "memantine and donepezil", "美金刚多奈哌齐", "盐酸美金刚盐酸多奈哌齐", "NDA 206439" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "神经与认知", "sourceArchiveMarket": "美国 NAMZARIC 盐酸美金刚/盐酸多奈哌齐缓释口服胶囊当前公开标签（DailyMed：2026-03-06 修订，SPL v23；NDA 206439）", "dosageFormClass": "缓释口服胶囊：每粒 7 mg/10 mg、14 mg/10 mg、21 mg/10 mg 或 28 mg/10 mg（前者为盐酸美金刚，后者为盐酸多奈哌齐；当前美国标签所列）", "dosageFormClassCode": "oral_modified_release", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "2014（当前美国标签所列 Initial U.S. Approval）", "archiveSponsorText": "AbbVie Inc.（当前美国公开标签所列分销方；标签另列 Merz Pharma 与 Adamas Pharmaceuticals 授权关系）" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [ "NAMENDA", "NAMENDA XR", "ARICEPT", "memantine tablet", "donepezil tablet", "美金刚片", "多奈哌齐片", "separate memantine and donepezil products", "分开的美金刚与多奈哌齐产品" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-namzaric-memantine-donepezil-er-capsule-7mg-10mg-30-bottle-ndc-0456-1207-30", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国标签（2026-03-06 修订；SPL v23）", "en": "Current U.S. DailyMed label (revised 6 Mar 2026; SPL v23)" }, "dosageForm": { "zh": "NAMZARIC 盐酸美金刚/盐酸多奈哌齐缓释口服胶囊", "en": "NAMZARIC memantine/donepezil hydrochlorides extended-release oral capsule" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 0456-1207-30", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_capsule", "primaryDisplay": { "zh": "每粒：盐酸美金刚 7 mg + 盐酸多奈哌齐 10 mg；30 粒瓶装", "en": "Per capsule: memantine hydrochloride 7 mg + donepezil hydrochloride 10 mg; 30-capsule bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=namzaric-0b.jpg&setid=90fedc32-19e5-480c-afc6-f35a5cf4b9aa&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "盐酸美金刚", "en": "memantine hydrochloride" }, "value": 7, "unit": "mg", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒第一种成分的标签标示量；不是个人胶囊数或递增指令", "en": "labelled amount of the first ingredient per capsule; not an individual capsule count or titration instruction" } }, { "ingredient": { "zh": "盐酸多奈哌齐", "en": "donepezil hydrochloride" }, "value": 10, "unit": "mg", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒第二种成分的标签标示量；不是与 7 mg 相除或相加的计算式", "en": "labelled amount of the second ingredient per capsule; not a division or addition formula with 7 mg" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "30 粒瓶装", "en": "30-capsule bottle" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-28", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 30, "unit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "physicalClues": { "color": { "zh": "浅绿色不透明胶囊体、橙色不透明胶囊帽", "en": "light-green opaque body and orange opaque cap" }, "shape": { "zh": "缓释胶囊", "en": "extended-release capsule" }, "imprint": "FL 7/10", "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_aef2a99c82265450", "label": "DailyMed（NLM）：NAMZARIC 7 mg/10 mg、NDC 0456-1207-30、30 粒瓶装当前美国标签面板（AbbVie；SPL v23）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=90fedc32-19e5-480c-afc6-f35a5cf4b9aa", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-namzaric-memantine-donepezil-er-capsule-14mg-10mg-30-bottle-ndc-0456-1214-30", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国标签（2026-03-06 修订；SPL v23）", "en": "Current U.S. DailyMed label (revised 6 Mar 2026; SPL v23)" }, "dosageForm": { "zh": "NAMZARIC 盐酸美金刚/盐酸多奈哌齐缓释口服胶囊", "en": "NAMZARIC memantine/donepezil hydrochlorides extended-release oral capsule" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 0456-1214-30", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_capsule", "primaryDisplay": { "zh": "每粒：盐酸美金刚 14 mg + 盐酸多奈哌齐 10 mg；30 粒瓶装", "en": "Per capsule: memantine hydrochloride 14 mg + donepezil hydrochloride 10 mg; 30-capsule bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=namzaric-0c.jpg&setid=90fedc32-19e5-480c-afc6-f35a5cf4b9aa&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "盐酸美金刚", "en": "memantine hydrochloride" }, "value": 14, "unit": "mg", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒第一种成分的标签标示量；不是个人胶囊数或递增指令", "en": "labelled amount of the first ingredient per capsule; not an individual capsule count or titration instruction" } }, { "ingredient": { "zh": "盐酸多奈哌齐", "en": "donepezil hydrochloride" }, "value": 10, "unit": "mg", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒第二种成分的标签标示量；不是与 14 mg 相除或相加的计算式", "en": "labelled amount of the second ingredient per capsule; not a division or addition formula with 14 mg" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "30 粒瓶装", "en": "30-capsule bottle" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-28", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 30, "unit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "physicalClues": { "color": { "zh": "浅绿色不透明胶囊", "en": "light-green opaque capsule" }, "shape": { "zh": "缓释胶囊", "en": "extended-release capsule" }, "imprint": "FL 14/10", "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_aef2a99c82265450", "label": "DailyMed（NLM）：NAMZARIC 14 mg/10 mg、NDC 0456-1214-30、30 粒瓶装当前美国标签面板（AbbVie；SPL v23）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=90fedc32-19e5-480c-afc6-f35a5cf4b9aa", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-namzaric-memantine-donepezil-er-capsule-21mg-10mg-30-bottle-ndc-0456-1221-30", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国标签（2026-03-06 修订；SPL v23）", "en": "Current U.S. DailyMed label (revised 6 Mar 2026; SPL v23)" }, "dosageForm": { "zh": "NAMZARIC 盐酸美金刚/盐酸多奈哌齐缓释口服胶囊", "en": "NAMZARIC memantine/donepezil hydrochlorides extended-release oral capsule" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 0456-1221-30", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_capsule", "primaryDisplay": { "zh": "每粒：盐酸美金刚 21 mg + 盐酸多奈哌齐 10 mg；30 粒瓶装", "en": "Per capsule: memantine hydrochloride 21 mg + donepezil hydrochloride 10 mg; 30-capsule bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=namzaric-0d.jpg&setid=90fedc32-19e5-480c-afc6-f35a5cf4b9aa&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "盐酸美金刚", "en": "memantine hydrochloride" }, "value": 21, "unit": "mg", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒第一种成分的标签标示量；不是个人胶囊数或递增指令", "en": "labelled amount of the first ingredient per capsule; not an individual capsule count or titration instruction" } }, { "ingredient": { "zh": "盐酸多奈哌齐", "en": "donepezil hydrochloride" }, "value": 10, "unit": "mg", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒第二种成分的标签标示量；不是与 21 mg 相除或相加的计算式", "en": "labelled amount of the second ingredient per capsule; not a division or addition formula with 21 mg" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "30 粒瓶装", "en": "30-capsule bottle" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-28", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 30, "unit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "physicalClues": { "color": { "zh": "白色不透明胶囊体、橙色不透明胶囊帽", "en": "white opaque body and orange opaque cap" }, "shape": { "zh": "缓释胶囊", "en": "extended-release capsule" }, "imprint": "FL 21/10", "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_aef2a99c82265450", "label": "DailyMed（NLM）：NAMZARIC 21 mg/10 mg、NDC 0456-1221-30、30 粒瓶装当前美国标签面板（AbbVie；SPL v23）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=90fedc32-19e5-480c-afc6-f35a5cf4b9aa", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-namzaric-memantine-donepezil-er-capsule-28mg-10mg-30-bottle-ndc-0456-1228-30", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国标签（2026-03-06 修订；SPL v23）", "en": "Current U.S. DailyMed label (revised 6 Mar 2026; SPL v23)" }, "dosageForm": { "zh": "NAMZARIC 盐酸美金刚/盐酸多奈哌齐缓释口服胶囊", "en": "NAMZARIC memantine/donepezil hydrochlorides extended-release oral capsule" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 0456-1228-30", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_capsule", "primaryDisplay": { "zh": "每粒：盐酸美金刚 28 mg + 盐酸多奈哌齐 10 mg；30 粒瓶装", "en": "Per capsule: memantine hydrochloride 28 mg + donepezil hydrochloride 10 mg; 30-capsule bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=namzaric-0e.jpg&setid=90fedc32-19e5-480c-afc6-f35a5cf4b9aa&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "盐酸美金刚", "en": "memantine hydrochloride" }, "value": 28, "unit": "mg", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒第一种成分的标签标示量；不是个人胶囊数或递增指令", "en": "labelled amount of the first ingredient per capsule; not an individual capsule count or titration instruction" } }, { "ingredient": { "zh": "盐酸多奈哌齐", "en": "donepezil hydrochloride" }, "value": 10, "unit": "mg", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒第二种成分的标签标示量；不是与 28 mg 相除或相加的计算式", "en": "labelled amount of the second ingredient per capsule; not a division or addition formula with 28 mg" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "30 粒瓶装", "en": "30-capsule bottle" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-28", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 30, "unit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "physicalClues": { "color": { "zh": "蓝色不透明胶囊", "en": "blue opaque capsule" }, "shape": { "zh": "缓释胶囊", "en": "extended-release capsule" }, "imprint": "FL 28/10", "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_aef2a99c82265450", "label": "DailyMed（NLM）：NAMZARIC 28 mg/10 mg、NDC 0456-1228-30、30 粒瓶装当前美国标签面板（AbbVie；SPL v23）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=90fedc32-19e5-480c-afc6-f35a5cf4b9aa", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-namzaric-memantine-donepezil-er-capsule-7mg-10mg-30-bottle-ndc-0456-1207-30", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=namzaric-0b.jpg&setid=90fedc32-19e5-480c-afc6-f35a5cf4b9aa&type=img", "alt": "NAMZARIC 盐酸美金刚/盐酸多奈哌齐在美国 DailyMed 当前标签中的 7 mg/10 mg、NDC 0456-1207-30、30 粒瓶装展示面", "archiveMarket": "美国", "labelVersion": "DailyMed 当前标签（2026-03-06 修订；SPL v23）", "presentation": "NAMZARIC：每粒盐酸美金刚 7 mg + 盐酸多奈哌齐 10 mg，NDC 0456-1207-30，30 粒瓶装。", "notice": "此图只对应美国 DailyMed 当前标签中的 NAMZARIC 7 mg/10 mg、NDC 0456-1207-30 与 30 粒瓶装。它只帮助核对品牌、双成分、每粒两组标签量、缓释胶囊、包装数量和来源；不用于鉴定真伪，也不证明其他强度、滴定包装、分开的美金刚或多奈哌齐产品、其他市场、实际可得性、原研身份、可替代性或任何个人的胶囊数、打开方式、联用、停用、换药方案。", "source": { "id": "src_aef2a99c82265450", "label": "DailyMed（NLM）：NAMZARIC 7 mg/10 mg、NDC 0456-1207-30、30 粒瓶装当前美国标签面板（AbbVie；SPL v23）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=90fedc32-19e5-480c-afc6-f35a5cf4b9aa", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "NAMZARIC 说明书放大阅读：斜线两侧是同一粒胶囊中的两种成分，不是除法或两颗药", "en": "NAMZARIC label reading: the two numbers identify two ingredients in one capsule, not division or two medicines" }, "summary": { "zh": "本模块只阅读当前美国标签中的 NAMZARIC、盐酸美金刚、盐酸多奈哌齐、四种缓释胶囊强度、准确 NDC、包装面板和胶囊处理文字。它不提供个人胶囊数、递增、漏用补救、开始、停用、联用、换药或购买方案。", "en": "This module reads only NAMZARIC, memantine hydrochloride, donepezil hydrochloride, four extended-release capsule strengths, exact NDCs, package panels and capsule-handling text in the current U.S. label. It provides no individual capsule count, titration, missed-use remedy, initiation, stopping, co-use, switching or purchase plan." }, "checks": [ { "zh": "先把 NAMZARIC、两种成分、7/10、14/10、21/10 或 28/10 mg、准确 NDC、缓释胶囊和目标市场一起核对。斜线前是盐酸美金刚，斜线后是盐酸多奈哌齐；它不是数学除法，也不是两颗可分开的药。", "en": "Check NAMZARIC, both ingredients, 7/10, 14/10, 21/10 or 28/10 mg, the exact NDC, extended-release capsule and target market together. The number before the slash is memantine hydrochloride and the number after it is donepezil hydrochloride; this is not mathematical division or two separable medicines." }, { "zh": "当前标签写明胶囊可完整吞服；在该准确产品的标签条件下，也可打开后把全部内容撒在苹果酱上立即吞下且不要咀嚼，但不能只取一部分，不能分次。这个产品级例外不代表其他缓释胶囊也能打开，更不是网页要求任何人这样做。", "en": "The current label says the capsule may be swallowed intact. Under this exact product's labelled conditions it may also be opened, with all contents sprinkled on applesauce and swallowed immediately without chewing; only part must not be used and the dose must not be divided. This product-specific exception does not mean another extended-release capsule may be opened and is not an instruction from this site for anyone to do so." }, { "zh": "NAMZARIC 已同时含美金刚与多奈哌齐。药单中若另有 NAMENDA、NAMENDA XR、ARICEPT、其他美金刚/多奈哌齐或认知相关药，必须先按完整成分表请药师或开方团队核对重复成分、剂型和处方转换；不要自行叠加、轮换或停掉其中任何一盒。", "en": "NAMZARIC already contains memantine and donepezil. If the medicine list also includes NAMENDA, NAMENDA XR, ARICEPT, another memantine/donepezil product or a cognition-related medicine, have a pharmacist or prescriber review duplicate ingredients, dosage forms and the prescribed transition from the complete ingredient list before any change; do not self-add, alternate or stop any pack." }, { "zh": "标签中的肾功能、心率/传导、晕厥、胃肠道、泌尿、癫痫、肺部情况和相互作用段落用于提示需要专业核对，不让网页判断某个头晕、跌倒、意识改变、恶心、食欲变化或其他不适是否由这款药造成。急性或严重变化应及时使用当地医疗支持。", "en": "The label's kidney, heart-rate/conduction, fainting, gastrointestinal, urinary, seizure, pulmonary and interaction sections identify matters for professional review; they do not let a webpage determine whether dizziness, a fall, altered consciousness, nausea, appetite change or another concern was caused by this medicine. Use timely local medical support for an acute or serious change." } ], "source": { "id": "src_aef2a99c82265450", "label": "DailyMed（NLM）：NAMZARIC 盐酸美金刚/盐酸多奈哌齐当前美国公开标签（AbbVie；2026-03 修订，SPL v23）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=90fedc32-19e5-480c-afc6-f35a5cf4b9aa", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "NAMZARIC 的两条作用路径：美金刚关联 NMDA 受体，多奈哌齐抑制乙酰胆碱酯酶", "en": "NAMZARIC's two pathways: memantine relates to NMDA receptors and donepezil inhibits acetylcholinesterase" }, "summary": { "zh": "当前美国标签说明 NAMZARIC 含两种已批准成分：美金刚被描述为低至中等亲和力、非竞争性 NMDA 受体拮抗剂；多奈哌齐被描述为可逆性乙酰胆碱酯酶抑制剂。两条机制帮助理解复方身份，不预测个人认知变化、适用性、起效时间、胶囊数或联用方案。", "en": "The current U.S. label states that NAMZARIC contains two approved ingredients: memantine is described as a low-to-moderate-affinity uncompetitive NMDA-receptor antagonist, and donepezil as a reversible acetylcholinesterase inhibitor. The two pathways help explain the combination identity; they do not predict an individual's cognitive change, suitability, onset, capsule count or co-use plan." }, "checks": [ { "zh": "两条机制不等于“两种药越多越强”，也不表示可以把 NAMZARIC 与分开的美金刚或多奈哌齐自行叠加。固定复方、单方、普通释放和缓释产品必须按准确药盒与处方分别核对。", "en": "Two pathways do not mean that more ingredients are stronger, or that NAMZARIC may be self-added to separate memantine or donepezil. Fixed combinations, single-ingredient products, immediate-release and extended-release forms must be checked separately against the exact pack and prescription." }, { "zh": "机制不能把 7、14、21、28 mg 或固定的 10 mg 变成个人递增、减量、拆分、停药或换药规则，也不能解释每一次记忆、行为、睡眠、胃口或跌倒变化。", "en": "Mechanism cannot turn 7, 14, 21 or 28 mg, or the fixed 10 mg component, into an individual titration, reduction, division, stopping or switching rule, and it cannot explain every change in memory, behaviour, sleep, appetite or falls." }, { "zh": "照护者若不确定药单是否重复、患者是否吞咽了完整胶囊，或出现明显急性变化，应把实际药盒、全部处方/非处方药和发生时间带给药师、开方团队或当地急救支持；不要从药理名词自行补用或重给。", "en": "If a caregiver is unsure whether the medicine list duplicates ingredients, whether a whole capsule was swallowed, or notices a marked acute change, take the actual packs, all prescription/OTC products and the timing to a pharmacist, prescriber or local urgent support; do not self-repeat or redose from pharmacology terms." } ], "source": { "id": "src_aef2a99c82265450", "label": "DailyMed（NLM）：NAMZARIC 当前美国公开标签（Clinical Pharmacology；AbbVie；2026-03 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=90fedc32-19e5-480c-afc6-f35a5cf4b9aa", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "NAMZARIC", "generic": "盐酸美金刚/盐酸多奈哌齐（复方）", "dosageFormClass": "缓释口服胶囊：每粒 7 mg/10 mg、14 mg/10 mg、21 mg/10 mg 或 28 mg/10 mg（前者为盐酸美金刚，后者为盐酸多奈哌齐；当前美国标签所列）" }, "labelSource": { "id": "src_aef2a99c82265450", "label": "DailyMed（NLM）：NAMZARIC 盐酸美金刚/盐酸多奈哌齐当前美国公开标签（AbbVie；2026-03-06 修订，SPL v23）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=90fedc32-19e5-480c-afc6-f35a5cf4b9aa", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" }, "productRoutes": [ { "source": { "id": "src_aef2a99c82265450", "label": "DailyMed（NLM）：NAMZARIC 盐酸美金刚/盐酸多奈哌齐当前美国公开标签（AbbVie；2026-03-06 修订，SPL v23）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=90fedc32-19e5-480c-afc6-f35a5cf4b9aa", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-28", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-28", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "美国 DailyMed 当前 NAMZARIC 标签将其列为盐酸美金刚与盐酸多奈哌齐的缓释口服复方胶囊，并列出 7/10、14/10、21/10 和 28/10 mg 四种每粒成分量。本页帮助照护者先识别两种成分、斜线两侧数字、缓释胶囊、准确 NDC、瓶装面板和标签来源；不把这些数字或说明书文字变成个人胶囊数、递增、漏用补救、打开胶囊、停用、联用、换药或购买方案。", "history": "当前美国公开标签列示 Initial U.S. Approval: 2014，并标示 2026-03 修订。标签说明 NAMZARIC 是美金刚与多奈哌齐的固定复方缓释胶囊；这不表示它与分开的 NAMENDA、NAMENDA XR、ARICEPT、其他美金刚/多奈哌齐产品或其他市场包装可以自行叠加、拆分、轮换或按毫克换算。", "sourceDocuments": [ { "id": "src_aef2a99c82265450", "label": "DailyMed（NLM）：NAMZARIC 盐酸美金刚/盐酸多奈哌齐当前美国公开标签（AbbVie；2026-03-06 修订，SPL v23）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=90fedc32-19e5-480c-afc6-f35a5cf4b9aa", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" } ], "applicationNumber": "NDA 206439", "approvalTimeline": [ { "date": "2014", "title": { "zh": "FDA 标签所列美国初始批准年份", "en": "Initial U.S. approval year listed in the FDA label" }, "detail": { "zh": "本页链接的 FDA 标签档案列示 Initial U.S. Approval: 2014。该历史定位不等同于当前批准、可得性、持有人或其他市场状态。", "en": "The FDA label archive linked here lists Initial U.S. Approval: 2014. This historical locator is not a conclusion about current approval, availability, holder or another market." }, "source": { "id": "src_aef2a99c82265450", "label": "DailyMed: NAMZARIC memantine and donepezil hydrochlorides current U.S. public label", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=90fedc32-19e5-480c-afc6-f35a5cf4b9aa", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" } }, { "date": "2026-03-06 revised; DailyMed SPL v23", "title": { "zh": "FDA 标签档案版本", "en": "FDA label archive version" }, "detail": { "zh": "本页链接 2026-03-06 revised; DailyMed SPL v23 的 FDA 标签档案作为可复核阅读入口。现行标签、规格、适应症和安全信息必须另行以目标市场当前文件核对。", "en": "This page links the 2026-03-06 revised; DailyMed SPL v23 FDA label archive as a traceable reading entry point. Current labeling, strength, indication and safety information require separate verification against the target market’s current document." }, "source": { "id": "src_aef2a99c82265450", "label": "DailyMed: NAMZARIC memantine and donepezil hydrochlorides current U.S. public label", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=90fedc32-19e5-480c-afc6-f35a5cf4b9aa", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "已链接公开标签档案", "en": "Public label archive linked" }, "detail": { "zh": "仅对应本页所列 FDA 文件。", "en": "Only the FDA document listed on this page is linked." } }, { "market": { "zh": "中国大陆、欧盟、日本", "en": "Mainland China, EU, Japan" }, "status": { "zh": "待逐项建立市场记录", "en": "Market record not established" }, "detail": { "zh": "不从美国标签档案推定当地批准、持有人、规格、供应或可售资格。", "en": "No local approval, holder, strength, supply or sale-eligibility conclusion is inferred from the U.S. label archive." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "标签档案能代表现在的产品信息吗？", "en": "Does a label archive represent current product information?" }, "answer": { "zh": "不能自动代表。档案用于定位来源；需要以目标市场的现行官方标签逐项复核。", "en": "Not automatically. The archive locates a source; each point needs verification against the target market’s current official label." } }, { "question": { "zh": "为什么这里不展示价格或原研/仿制结论？", "en": "Why are price and originator/generic conclusions not shown?" }, "answer": { "zh": "这些结论需要产品、剂型、规格、包装、市场、日期和原始记录分别齐全并经人工审核；单一标签文件不足以支持。", "en": "Those conclusions require separately complete and human-reviewed product, dosage-form, strength, pack, market, date and primary-record fields; one label file is insufficient." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "how-to-read-a-drug-label", "regulatory-sources-first" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/namzaric/", "en": "https://origindrug.com/en/drugs/namzaric/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "exelon-oral", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-28", "status": "published_traceable_archive" }, "names": { "brand": "Exelon Oral", "generic": "利斯的明口服胶囊/口服液", "aliases": [ "EXELON", "rivastigmine", "rivastigmine hard capsules", "rivastigmine oral solution", "利斯的明胶囊", "利斯的明口服液", "rivastigmine capsules", "EXELON capsules", "EXELON capsules 1.5 mg", "EXELON capsules 3 mg", "EXELON capsules 4.5 mg", "EXELON capsules 6 mg", "EXELON oral solution", "EXELON oral solution 2 mg/ml", "1.5 mg", "3 mg", "4.5 mg", "6 mg", "2 mg/ml" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "神经与认知", "sourceArchiveMarket": "欧盟当前 EXELON 利斯的明胶囊与口服液产品资料（EMA 页面 2026-02-24 更新；产品资料 PDF 2026-02）", "dosageFormClass": "口服硬胶囊：1.5、3、4.5、6 mg；口服液：2 mg/mL（欧盟当前产品资料所列）", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "1998-05-12（EMA 所列欧盟上市许可日期；当前口服产品资料于 2026-02 更新）", "archiveSponsorText": "Novartis Europharm Limited / European Medicines Agency 当前欧盟产品资料" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [ "EXELON oral solution 2 mg/ml", "EXELON capsules 1.5 mg", "EXELON capsules 3 mg", "EXELON capsules 4.5 mg", "EXELON capsules 6 mg", "利斯的明口服液", "利斯的明胶囊" ], "excludedProductCues": [ "EXELON PATCH", "rivastigmine transdermal system", "rivastigmine patch", "透皮贴剂", "mg/24h" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "eu-exelon-hard-capsule-1-5mg", "marketCode": "EU", "labelVersion": { "zh": "EMA 当前欧盟产品资料（2026-02-09 PDF 元数据；2026-08-28 核验）", "en": "Current EMA EU product information (PDF metadata 9 Feb 2026; checked 28 Aug 2026)" }, "dosageForm": { "zh": "EXELON 利斯的明硬胶囊", "en": "EXELON rivastigmine hard capsule" }, "route": { "zh": "口服（标签产品身份字段）", "en": "oral (label product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "EU/1/98/066/001-003", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_capsule", "primaryDisplay": { "zh": "每粒利斯的明 1.5 mg；欧盟产品资料列示 28、56、112 粒包装", "en": "Rivastigmine 1.5 mg per capsule; EU product information lists 28, 56, 112-capsule packs" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "利斯的明", "en": "rivastigmine" }, "value": 1.5, "unit": "mg", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒标签标示量；不是个人胶囊数、频次、转换或加减量指令", "en": "labelled amount per capsule; not an individual capsule count, frequency, conversion or adjustment instruction" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-28", "currentLabelDisplayed": true, "ndcDirectoryListed": false, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": null, "physicalClues": { "color": { "zh": "黄色帽/黄色体；红色压印", "en": "yellow cap/yellow body; red imprint" }, "shape": { "zh": "硬胶囊；内装类白色至微黄色粉末", "en": "hard capsule containing off-white to slightly yellow powder" }, "imprint": "EXELON 1,5 mg", "scoreStatus": "not_applicable", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_11f6dce81d63da04", "label": "EMA：EXELON 利斯的明胶囊/口服液当前欧盟产品资料（2026-02）", "url": "https://www.ema.europa.eu/en/documents/product-information/exelon-epar-product-information_en.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "eu-exelon-hard-capsule-3mg", "marketCode": "EU", "labelVersion": { "zh": "EMA 当前欧盟产品资料（2026-02-09 PDF 元数据；2026-08-28 核验）", "en": "Current EMA EU product information (PDF metadata 9 Feb 2026; checked 28 Aug 2026)" }, "dosageForm": { "zh": "EXELON 利斯的明硬胶囊", "en": "EXELON rivastigmine hard capsule" }, "route": { "zh": "口服（标签产品身份字段）", "en": "oral (label product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "EU/1/98/066/004-006", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_capsule", "primaryDisplay": { "zh": "每粒利斯的明 3 mg；欧盟产品资料列示 28、56、112 粒包装", "en": "Rivastigmine 3 mg per capsule; EU product information lists 28, 56, 112-capsule packs" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "利斯的明", "en": "rivastigmine" }, "value": 3, "unit": "mg", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒标签标示量；不是个人胶囊数、频次、转换或加减量指令", "en": "labelled amount per capsule; not an individual capsule count, frequency, conversion or adjustment instruction" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-28", "currentLabelDisplayed": true, "ndcDirectoryListed": false, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": null, "physicalClues": { "color": { "zh": "橙色帽/橙色体；红色压印", "en": "orange cap/orange body; red imprint" }, "shape": { "zh": "硬胶囊；内装类白色至微黄色粉末", "en": "hard capsule containing off-white to slightly yellow powder" }, "imprint": "EXELON 3 mg", "scoreStatus": "not_applicable", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_11f6dce81d63da04", "label": "EMA：EXELON 利斯的明胶囊/口服液当前欧盟产品资料（2026-02）", "url": "https://www.ema.europa.eu/en/documents/product-information/exelon-epar-product-information_en.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "eu-exelon-hard-capsule-4-5mg", "marketCode": "EU", "labelVersion": { "zh": "EMA 当前欧盟产品资料（2026-02-09 PDF 元数据；2026-08-28 核验）", "en": "Current EMA EU product information (PDF metadata 9 Feb 2026; checked 28 Aug 2026)" }, "dosageForm": { "zh": "EXELON 利斯的明硬胶囊", "en": "EXELON rivastigmine hard capsule" }, "route": { "zh": "口服（标签产品身份字段）", "en": "oral (label product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "EU/1/98/066/007-009", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_capsule", "primaryDisplay": { "zh": "每粒利斯的明 4.5 mg；欧盟产品资料列示 28、56、112 粒包装", "en": "Rivastigmine 4.5 mg per capsule; EU product information lists 28, 56, 112-capsule packs" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "利斯的明", "en": "rivastigmine" }, "value": 4.5, "unit": "mg", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒标签标示量；不是个人胶囊数、频次、转换或加减量指令", "en": "labelled amount per capsule; not an individual capsule count, frequency, conversion or adjustment instruction" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-28", "currentLabelDisplayed": true, "ndcDirectoryListed": false, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": null, "physicalClues": { "color": { "zh": "红色帽/红色体；白色压印", "en": "red cap/red body; white imprint" }, "shape": { "zh": "硬胶囊；内装类白色至微黄色粉末", "en": "hard capsule containing off-white to slightly yellow powder" }, "imprint": "EXELON 4,5 mg", "scoreStatus": "not_applicable", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_11f6dce81d63da04", "label": "EMA：EXELON 利斯的明胶囊/口服液当前欧盟产品资料（2026-02）", "url": "https://www.ema.europa.eu/en/documents/product-information/exelon-epar-product-information_en.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "eu-exelon-hard-capsule-6mg", "marketCode": "EU", "labelVersion": { "zh": "EMA 当前欧盟产品资料（2026-02-09 PDF 元数据；2026-08-28 核验）", "en": "Current EMA EU product information (PDF metadata 9 Feb 2026; checked 28 Aug 2026)" }, "dosageForm": { "zh": "EXELON 利斯的明硬胶囊", "en": "EXELON rivastigmine hard capsule" }, "route": { "zh": "口服（标签产品身份字段）", "en": "oral (label product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "EU/1/98/066/010-012", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_capsule", "primaryDisplay": { "zh": "每粒利斯的明 6 mg；欧盟产品资料列示 28、56、112 粒包装", "en": "Rivastigmine 6 mg per capsule; EU product information lists 28, 56, 112-capsule packs" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "利斯的明", "en": "rivastigmine" }, "value": 6, "unit": "mg", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒标签标示量；不是个人胶囊数、频次、转换或加减量指令", "en": "labelled amount per capsule; not an individual capsule count, frequency, conversion or adjustment instruction" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-28", "currentLabelDisplayed": true, "ndcDirectoryListed": false, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": null, "physicalClues": { "color": { "zh": "红色帽/橙色体；红色压印", "en": "red cap/orange body; red imprint" }, "shape": { "zh": "硬胶囊；内装类白色至微黄色粉末", "en": "hard capsule containing off-white to slightly yellow powder" }, "imprint": "EXELON 6 mg", "scoreStatus": "not_applicable", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_11f6dce81d63da04", "label": "EMA：EXELON 利斯的明胶囊/口服液当前欧盟产品资料（2026-02）", "url": "https://www.ema.europa.eu/en/documents/product-information/exelon-epar-product-information_en.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "eu-exelon-oral-solution-2mgml-50ml", "marketCode": "EU", "labelVersion": { "zh": "EMA 当前欧盟产品资料（2026-02-09 PDF 元数据；2026-08-28 核验）", "en": "Current EMA EU product information (PDF metadata 9 Feb 2026; checked 28 Aug 2026)" }, "dosageForm": { "zh": "EXELON 利斯的明口服液", "en": "EXELON rivastigmine oral solution" }, "route": { "zh": "口服（标签产品身份字段）", "en": "oral (label product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "EU/1/98/066/018", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_mL", "primaryDisplay": { "zh": "利斯的明 2 mg/mL；50 mL 棕色玻璃瓶；配口服给药器", "en": "Rivastigmine 2 mg/mL; 50 mL amber-glass bottle with oral dosing syringe" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "利斯的明", "en": "rivastigmine" }, "value": 2, "unit": "mg/mL", "basisCode": "per_mL", "basisLabel": { "zh": "每毫升浓度；不是个人毫升数或自行换算指令", "en": "concentration per mL; not an individual's millilitres or a self-conversion instruction" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-28", "currentLabelDisplayed": true, "ndcDirectoryListed": false, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 50, "unit": { "zh": "mL/瓶；随附口服给药器", "en": "mL per bottle; oral dosing syringe supplied" } }, "physicalClues": { "color": { "zh": "澄清黄色溶液", "en": "clear yellow solution" }, "shape": null, "imprint": null, "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_11f6dce81d63da04", "label": "EMA：EXELON 利斯的明胶囊/口服液当前欧盟产品资料（2026-02）", "url": "https://www.ema.europa.eu/en/documents/product-information/exelon-epar-product-information_en.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "eu-exelon-oral-solution-2mgml-120ml", "marketCode": "EU", "labelVersion": { "zh": "EMA 当前欧盟产品资料（2026-02-09 PDF 元数据；2026-08-28 核验）", "en": "Current EMA EU product information (PDF metadata 9 Feb 2026; checked 28 Aug 2026)" }, "dosageForm": { "zh": "EXELON 利斯的明口服液", "en": "EXELON rivastigmine oral solution" }, "route": { "zh": "口服（标签产品身份字段）", "en": "oral (label product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "EU/1/98/066/013", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_mL", "primaryDisplay": { "zh": "利斯的明 2 mg/mL；120 mL 棕色玻璃瓶；配口服给药器", "en": "Rivastigmine 2 mg/mL; 120 mL amber-glass bottle with oral dosing syringe" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "利斯的明", "en": "rivastigmine" }, "value": 2, "unit": "mg/mL", "basisCode": "per_mL", "basisLabel": { "zh": "每毫升浓度；不是个人毫升数或自行换算指令", "en": "concentration per mL; not an individual's millilitres or a self-conversion instruction" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-28", "currentLabelDisplayed": true, "ndcDirectoryListed": false, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 120, "unit": { "zh": "mL/瓶；随附口服给药器", "en": "mL per bottle; oral dosing syringe supplied" } }, "physicalClues": { "color": { "zh": "澄清黄色溶液", "en": "clear yellow solution" }, "shape": null, "imprint": null, "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_11f6dce81d63da04", "label": "EMA：EXELON 利斯的明胶囊/口服液当前欧盟产品资料（2026-02）", "url": "https://www.ema.europa.eu/en/documents/product-information/exelon-epar-product-information_en.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "status": "withheld_repackaged_or_non_exact_visual", "title": { "zh": "已核验 EMA 当前口服产品资料与胶囊外观文字，但未保留与单一强度、单一包装一一对应的官方原品牌包装图，故不展示包装图片", "en": "Current EMA oral-product information and capsule appearance text were reviewed, but no official original-brand package image matching one exact strength and pack was retained, so no package visual is shown" }, "summary": { "zh": "本档案保留 EXELON、利斯的明、四种胶囊强度、2 mg/mL 口服液、胶囊颜色与压印、口服液容器和欧盟许可号。EMA 当前产品资料提供准确文字身份，但此次未保留可安全公开展示且与单一剂型、单一规格和单一包装准确对应的官方原品牌包装图；为避免把零售图、版本不明图、其他市场图片、贴剂或另一种利斯的明产品误作准确口服 EXELON 外观，页面不展示包装图片，只保留一手产品资料供放大阅读。", "en": "This dossier retains EXELON, rivastigmine, four capsule strengths, the 2 mg/mL oral solution, capsule colours and imprints, oral-solution container and EU authorisation numbers. Current EMA product information provides exact textual identity, but no official original-brand image was retained that can safely be displayed and matched to one dosage form, one strength and one pack. To avoid presenting a retail image, version-uncertain image, another-market image, a patch or another rivastigmine product as the exact oral EXELON appearance, the page withholds package imagery and retains the primary product information for enlarged reading." }, "source": { "id": "src_11f6dce81d63da04", "label": "EMA：EXELON 利斯的明当前欧盟产品资料（2026-02）", "url": "https://www.ema.europa.eu/en/documents/product-information/exelon-epar-product-information_en.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "EXELON 口服说明书放大阅读：每粒 mg、每毫升 mg/mL 与贴剂 mg/24h 不是同一种数字", "en": "EXELON oral label reading: mg per capsule, mg/mL and patch mg/24h are different quantities" }, "summary": { "zh": "本模块以 EMA 当前欧盟产品资料为入口，帮助核对 EXELON、利斯的明、四种胶囊、2 mg/mL 口服液、准确许可号、外观文字和给药器。它不生成个人胶囊数、毫升数、频次、递增、漏用补救、开始、停用、口服制剂转换或口服—贴剂转换方案。", "en": "This module uses current EMA EU product information to check EXELON, rivastigmine, four capsule strengths, the 2 mg/mL oral solution, exact authorisation numbers, appearance text and the dosing syringe. It does not generate an individual's capsule count, millilitres, frequency, titration, missed-use remedy, initiation, stopping, oral-form conversion or oral-to-patch conversion." }, "checks": [ { "zh": "先看剂型，再看数字：胶囊的 1.5、3、4.5、6 mg 是每粒标示量；口服液的 2 mg/mL 是浓度；贴剂的 mg/24h 是 24 小时标称释放量。三类数字不能直接相除、相加或互换。", "en": "Check the dosage form before the number: 1.5, 3, 4.5 and 6 mg are amounts per capsule; 2 mg/mL is the oral-solution concentration; mg/24h is nominal patch delivery over 24 hours. These quantities cannot be directly divided, added or exchanged." }, { "zh": "EMA 产品资料列明胶囊应整粒吞服，外盒文字还写明不要压碎或打开。不要为获得“半量”自行打开、倒粉、分装或混合胶囊；包装、处方和药师意见必须一起核对。", "en": "EMA product information states that capsules are swallowed whole, and the package text says not to crush or open them. Do not open, pour out, divide or mix capsule contents to obtain a ‘half amount’; check the pack, prescription and pharmacist advice together." }, { "zh": "口服液是 2 mg/mL，随附口服给药器；瓶身 50 mL 或 120 mL 是容器总量，不是一次用量。网页不依据浓度、瓶量或说明书处方段落替个人计算毫升数。", "en": "The oral solution is 2 mg/mL and comes with an oral dosing syringe; 50 mL or 120 mL is the bottle content, not one use. The site does not calculate an individual's millilitres from concentration, bottle size or prescribing text." }, { "zh": "EMA 说明书描述胶囊与口服液在专业处方框架下的等剂量转换，但这不是让公众自行换算的授权。任何转换都应让医生或药师按准确处方、实际包装、给药器和中断情况处理。", "en": "The EMA label describes equal-dose interchange between capsules and oral solution within professional prescribing. This is not permission for public self-conversion. Any change needs a clinician or pharmacist using the exact prescription, actual pack, dosing syringe and interruption history." }, { "zh": "EXELON 口服制剂与 EXELON PATCH 是不同产品形态。不要按相同品牌或利斯的明成分自行叠加、轮换或换成贴剂；中断、漏用、呕吐、腹泻、体重下降或用药后明显不适，应联系负责治疗团队按当前说明书处理。", "en": "EXELON oral products and EXELON PATCH are different product forms. Do not self-combine, alternate or switch to a patch because they share a brand or rivastigmine. Interruption, missed use, vomiting, diarrhoea, weight loss or marked symptoms after use need the treating team and current product information." } ], "source": { "id": "src_11f6dce81d63da04", "label": "EMA：EXELON 利斯的明胶囊/口服液当前欧盟产品资料（2026-02）", "url": "https://www.ema.europa.eu/en/documents/product-information/exelon-epar-product-information_en.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "利斯的明怎样起作用：可逆抑制胆碱酯酶，不等于逆转基础病程", "en": "How rivastigmine works: reversible cholinesterase inhibition does not mean reversing the underlying disease" }, "summary": { "zh": "EMA 产品资料说明，利斯的明通过促进胆碱能神经传递来发挥作用，具体路径包括可逆抑制乙酰胆碱酯酶和丁酰胆碱酯酶；它用于帮助理解药理，不预测个人记忆变化、适用性、起效、胶囊数、毫升数或能否换剂型。", "en": "EMA product information describes rivastigmine as enhancing cholinergic neurotransmission through reversible inhibition of acetylcholinesterase and butyrylcholinesterase. This explains pharmacology; it does not predict an individual's memory change, suitability, onset, capsule count, millilitres or whether dosage forms can be switched." }, "checks": [ { "zh": "作用机制不是“越多越好”的依据，也不能根据症状自行加量、叠加其他胆碱酯酶抑制剂或突然停用。", "en": "Mechanism is not a ‘more is better’ rule and cannot justify self-increasing, adding another cholinesterase inhibitor or abrupt stopping." }, { "zh": "同一成分经胶囊、口服液或贴剂进入身体，产品身份、数字口径和说明书处理仍不同；机制相同不等于剂型可自行互换。", "en": "The same ingredient delivered by capsule, oral solution or patch still has different product identities, quantity conventions and label handling; shared mechanism does not make the forms self-interchangeable." }, { "zh": "老人常有多种处方药、非处方药和补充剂。请把实际药盒、给药器、完整药单和症状变化交给药师或处方团队逐项核对，网页不代替个体化评估。", "en": "Older people often use several prescriptions, OTC products and supplements. Bring the actual packs, dosing syringe, full medicine list and symptom changes for item-by-item review by a pharmacist or prescriber; the site does not replace individual assessment." } ], "source": { "id": "src_11f6dce81d63da04", "label": "EMA：EXELON 当前欧盟产品资料（药效学；2026-02）", "url": "https://www.ema.europa.eu/en/documents/product-information/exelon-epar-product-information_en.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "Exelon Oral", "generic": "利斯的明口服胶囊/口服液", "dosageFormClass": "口服硬胶囊：1.5、3、4.5、6 mg；口服液：2 mg/mL（欧盟当前产品资料所列）" }, "labelSource": { "id": "src_11f6dce81d63da04", "label": "EMA：EXELON 利斯的明当前欧盟产品资料（胶囊、口服液与贴剂；2026-02）", "url": "https://www.ema.europa.eu/en/documents/product-information/exelon-epar-product-information_en.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" }, "productRoutes": [ { "source": { "id": "src_11f6dce81d63da04", "label": "EMA：EXELON 利斯的明当前欧盟产品资料（胶囊、口服液与贴剂；2026-02）", "url": "https://www.ema.europa.eu/en/documents/product-information/exelon-epar-product-information_en.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" }, "status": "product_level_public_record_verified", "authority": { "zh": "EMA", "en": "EMA" }, "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "recordType": { "zh": "监管产品记录或欧盟产品资料", "en": "Regulatory product record or EU product information" }, "reviewedAt": "2026-08-28", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_7b8da8b5b6d44be9", "label": "EMA：EXELON 欧洲公共评估报告页面（2026-02-24 更新）", "url": "https://www.ema.europa.eu/en/medicines/human/EPAR/exelon", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "landing_page", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" }, "status": "product_level_public_record_verified", "authority": { "zh": "EMA", "en": "EMA" }, "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "recordType": { "zh": "监管产品记录或欧盟产品资料", "en": "Regulatory product record or EU product information" }, "reviewedAt": "2026-08-28", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "EMA", "en": "EMA" }, "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "recordType": { "zh": "监管产品记录或欧盟产品资料", "en": "Regulatory product record or EU product information" }, "reviewedAt": "2026-08-28", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "EMA 当前欧盟 EXELON 产品资料分别列出 1.5、3、4.5、6 mg 硬胶囊和 2 mg/mL 口服液。本页帮助老人和照护者先核对剂型、每粒标示量或每毫升浓度、胶囊颜色与压印、口服液瓶量、给药器和许可号；不把说明书中的处方文字变成个人胶囊数、毫升数、频次、递增、漏用补救、停用或换成贴剂的方案。", "history": "EMA 记录 EXELON 的欧盟上市许可自 1998-05-12 有效。当前产品资料同时覆盖胶囊、口服液和贴剂；本档案只建立口服产品路径，现有 EXELON PATCH 档案继续单独记录贴剂。共享品牌和成分不表示可按 mg 自行换算、叠加、轮换或替换。", "sourceDocuments": [ { "id": "src_7b8da8b5b6d44be9", "label": "EMA：EXELON 欧洲公共评估报告页面（2026-02-24 更新）", "url": "https://www.ema.europa.eu/en/medicines/human/EPAR/exelon", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "landing_page", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" }, { "id": "src_11f6dce81d63da04", "label": "EMA：EXELON 利斯的明当前欧盟产品资料（胶囊、口服液与贴剂；2026-02）", "url": "https://www.ema.europa.eu/en/documents/product-information/exelon-epar-product-information_en.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" } ], "applicationNumber": "EU/1/98/066（EMA 集中上市许可；本档案限当前欧盟口服产品资料）", "approvalTimeline": [ { "date": "1998-05-12", "title": { "zh": "EXELON 欧盟上市许可节点", "en": "EXELON EU marketing-authorisation node" }, "detail": { "zh": "EMA 产品页列示 EXELON 的欧盟上市许可自 1998-05-12 有效。本页以该节点定位欧盟品牌档案，不把它解释成其他市场的批准、供应或原研/仿制结论。", "en": "EMA lists EXELON's EU marketing authorisation as valid from 12 May 1998. This node locates the EU brand record; it is not treated as approval, supply or an originator/generic conclusion for another market." }, "source": { "id": "src_7b8da8b5b6d44be9", "label": "EMA：EXELON 欧洲公共评估报告页面", "url": "https://www.ema.europa.eu/en/medicines/human/EPAR/exelon", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "landing_page", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" } }, { "date": "2026-02-09", "title": { "zh": "当前欧盟产品资料版本", "en": "Current EU product-information version" }, "detail": { "zh": "EMA 当前产品资料 PDF 的修改日期为 2026-02-09，并分别列出 1.5、3、4.5、6 mg 胶囊和 2 mg/mL 口服液。该日期定位文件版本，不表示各规格在任何地点都有库存或可购买。", "en": "The current EMA product-information PDF has a modification date of 9 Feb 2026 and separately lists 1.5, 3, 4.5 and 6 mg capsules plus the 2 mg/mL oral solution. The date identifies a document version and does not establish local stock or purchase availability for every presentation." }, "source": { "id": "src_11f6dce81d63da04", "label": "EMA：EXELON 利斯的明当前欧盟产品资料", "url": "https://www.ema.europa.eu/en/documents/product-information/exelon-epar-product-information_en.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" } }, { "date": "2026-02-24", "title": { "zh": "EMA 产品页最近更新", "en": "EMA product page last updated" }, "detail": { "zh": "EMA 页面显示 Last updated 24 February 2026。本页将页面更新时间与产品资料日期分开记录，避免把网页维护日期误读成临床用法变化。", "en": "EMA displays ‘Last updated 24 February 2026’. This dossier keeps the page-update date separate from the product-information date so that a web-maintenance date is not misread as a change in clinical use." }, "source": { "id": "src_7b8da8b5b6d44be9", "label": "EMA：EXELON 欧洲公共评估报告页面", "url": "https://www.ema.europa.eu/en/medicines/human/EPAR/exelon", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "landing_page", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" } } ], "marketStatus": [ { "market": { "zh": "欧盟", "en": "European Union" }, "status": { "zh": "已链接当前产品资料与六个准确口服产品身份", "en": "Current product information and six exact oral-product identities linked" }, "detail": { "zh": "本页分别记录四种硬胶囊强度和两个口服液瓶量，均以 EMA 当前欧盟产品资料为边界；不建立库存、购买、真伪鉴定、个人用量或自行转换结论。", "en": "The dossier separately records four capsule strengths and two oral-solution bottle sizes, bounded by current EMA EU product information. It does not establish stock, purchase, authentication, individual use or self-directed conversion." } }, { "market": { "zh": "中国大陆、美国、日本及其他市场", "en": "Mainland China, United States, Japan and other markets" }, "status": { "zh": "待逐项建立现行市场记录", "en": "Current market record not established" }, "detail": { "zh": "不从欧盟许可、EMA 商品名、规格、包装文字或共同成分推定当地批准、持有人、供应、可售资格、原研/仿制关系或可替代性。", "en": "No local approval, holder, supply, sale eligibility, originator/generic relationship or interchangeability is inferred from the EU authorisation, EMA trade name, strengths, pack text or shared ingredient." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "2 mg/mL 是否表示一次就要使用 2 mg 或 1 mL？", "en": "Does 2 mg/mL mean one use must be 2 mg or 1 mL?" }, "answer": { "zh": "不是。2 mg/mL 是每毫升浓度，只是口服液产品身份字段。个人毫升数必须按准确处方、随附给药器和专业人员核对，网页不计算。", "en": "No. 2 mg/mL is the concentration per millilitre and identifies the oral-solution product. Individual millilitres require the exact prescription, supplied dosing syringe and professional review; the site does not calculate them." } }, { "question": { "zh": "EXELON 胶囊、口服液和贴剂能否只按 mg 自行换？", "en": "Can EXELON capsules, oral solution and patches be self-switched from mg numbers alone?" }, "answer": { "zh": "不能。每粒 mg、mg/mL 和 mg/24h 是不同口径。EMA 说明书中的转换文字属于专业处方框架，任何转换都要让医生或药师根据准确产品与中断情况处理。", "en": "No. Milligrams per capsule, mg/mL and mg/24h use different quantity bases. Conversion text in EMA product information belongs to professional prescribing; any change needs a clinician or pharmacist using the exact product and interruption history." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "dosage-forms-are-part-of-medicine-identity", "how-to-read-a-drug-label" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/exelon-oral/", "en": "https://origindrug.com/en/drugs/exelon-oral/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "mestinon", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-20", "status": "published_traceable_archive" }, "names": { "brand": "Mestinon", "generic": "溴吡斯的明", "aliases": [ "pyridostigmine", "pyridostigmine bromide" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "神经肌肉", "sourceArchiveMarket": "美国当前公开处方药标签（DailyMed SPL v20，2023-02-02 发布）", "dosageFormClass": "口服溶液、即释片与缓释片：相同品牌与通用名不建立自行换算、替换或掰开关系（美国公开标签所列）", "dosageFormClassCode": "oral_modified_release", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "1955–1965（DailyMed 当前美国标签所列三种剂型的历史营销记录节点）", "archiveSponsorText": "Bausch Health US, LLC / DailyMed（NLM）当前公开标签档案" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-mestinon-immediate-tablet-60mg-ndc-0187-3010-30", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v20（2023-02-02 发布）", "en": "DailyMed SPL v20 (published 2 February 2023)" }, "dosageForm": { "zh": "溴吡斯的明溴化物即释口服片", "en": "pyridostigmine bromide immediate-release oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 0187-3010-30", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片 60 mg；100 片瓶装", "en": "60 mg per tablet; 100-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=60mg-label-01.jpg&setid=a851795e-b7a8-40c3-9922-5e79d3eb4d92&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "溴吡斯的明溴化物", "en": "pyridostigmine bromide" }, "value": 60, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标示量", "en": "labelled amount per tablet" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": null, "package": { "count": 100, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "白色", "en": "white" }, "shape": { "zh": "圆片", "en": "round tablet" }, "imprint": "MESTINON / V / 60", "scoreStatus": "scored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_fbe1797b72543cef", "label": "DailyMed（NLM）：MESTINON 60 mg 即释片、100 片瓶装（NDC 0187-3010-30；SPL v20）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a851795e-b7a8-40c3-9922-5e79d3eb4d92", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-mestinon-timespan-er-tablet-180mg-ndc-0187-3013-30", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v20（2023-02-02 发布）", "en": "DailyMed SPL v20 (published 2 February 2023)" }, "dosageForm": { "zh": "MESTINON TIMESPAN 缓释口服片", "en": "MESTINON TIMESPAN extended-release oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 0187-3013-30", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片 180 mg；30 片瓶装（TIMESPAN 缓释片）", "en": "180 mg per tablet; 30-tablet bottle (TIMESPAN extended-release tablet)" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=image-01.jpg&setid=a851795e-b7a8-40c3-9922-5e79d3eb4d92&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "溴吡斯的明溴化物", "en": "pyridostigmine bromide" }, "value": 180, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标示量", "en": "labelled amount per tablet" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": null, "package": { "count": 30, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "浅黄色", "en": "light straw yellow" }, "shape": { "zh": "椭圆形胶囊状片", "en": "oval capsule-shaped tablet" }, "imprint": "MES / V / 180", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_fbe1797b72543cef", "label": "DailyMed（NLM）：MESTINON TIMESPAN 180 mg 缓释片、30 片瓶装（NDC 0187-3013-30；SPL v20）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a851795e-b7a8-40c3-9922-5e79d3eb4d92", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-mestinon-oral-solution-60mg-per-5ml-ndc-0187-3012-20", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v20（2023-02-02 发布）", "en": "DailyMed SPL v20 (published 2 February 2023)" }, "dosageForm": { "zh": "溴吡斯的明溴化物口服溶液", "en": "pyridostigmine bromide oral solution" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 0187-3012-20", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_5_mL", "primaryDisplay": { "zh": "每 5 mL 含 60 mg；473 mL 瓶装", "en": "60 mg per 5 mL; 473 mL bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=70394173-d6cf-49f7-8379-75d00bcd48fb-00.jpg&setid=a851795e-b7a8-40c3-9922-5e79d3eb4d92&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "溴吡斯的明溴化物", "en": "pyridostigmine bromide" }, "value": 60, "unit": "mg", "basisCode": "per_5_mL", "basisLabel": { "zh": "每 5 mL 标示量", "en": "labelled amount per 5 mL" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": { "value": 473, "unit": "mL" }, "countPerPackage": 1, "countUnit": { "zh": "瓶", "en": "bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": null, "package": { "count": 1, "unit": { "zh": "瓶/包装", "en": "bottle per package" } }, "physicalClues": { "color": { "zh": "液体制剂；请以准确标签和量取工具核对", "en": "liquid formulation; check the exact label and measuring device" }, "shape": null, "imprint": null, "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_fbe1797b72543cef", "label": "DailyMed（NLM）：MESTINON 口服溶液 60 mg/5 mL、473 mL 瓶装（NDC 0187-3012-20；SPL v20）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a851795e-b7a8-40c3-9922-5e79d3eb4d92", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-mestinon-immediate-tablet-60mg-ndc-0187-3010-30", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=60mg-label-01.jpg&setid=a851795e-b7a8-40c3-9922-5e79d3eb4d92&type=img", "alt": "MESTINON 溴吡斯的明溴化物 60 mg 即释口服片、NDC 0187-3010-30、100 片瓶装的美国 DailyMed 公开标签面板", "archiveMarket": "美国", "labelVersion": "DailyMed SPL v20（2023-02-02 发布）", "presentation": "MESTINON 溴吡斯的明溴化物 60 mg 即释口服片；NDC 0187-3010-30；100 片瓶装。", "notice": "此图只对应美国 DailyMed 公开标签中的 MESTINON 60 mg 即释片、NDC 0187-3010-30、100 片瓶装。它不代表 180 mg TIMESPAN 缓释片、60 mg/5 mL 口服溶液、其他包装、其他市场或当前可得性；不用于鉴定真伪，也不提供个人片数、口服液毫升数、掰开、替换或调整建议。", "source": { "id": "src_fbe1797b72543cef", "label": "DailyMed（NLM）：MESTINON 溴吡斯的明溴化物当前美国公开标签（Bausch Health；SPL v20）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a851795e-b7a8-40c3-9922-5e79d3eb4d92", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "MESTINON 说明书放大阅读：60 mg 片、180 mg TIMESPAN 与 60 mg/5 mL 口服液须分别核对", "en": "MESTINON label reading: 60 mg tablets, 180 mg TIMESPAN and 60 mg/5 mL oral solution must be checked separately" }, "summary": { "zh": "本模块以美国 DailyMed 公开标签为阅读入口，帮助核对 MESTINON、溴吡斯的明溴化物、准确剂型、每单位标示量、NDC 和包装。它不提供任何人的片数、口服液毫升数、间隔、漏用处理、联用、转换或停药方案。", "en": "This module uses the U.S. DailyMed public label to check MESTINON, pyridostigmine bromide, the exact form, labelled amount per unit, NDC and pack. It does not provide anyone's tablet count, oral-solution millilitres, interval, missed-use action, combination, switching or stopping plan." }, "checks": [ { "zh": "60 mg 即释片、180 mg TIMESPAN 缓释片和每 5 mL 含 60 mg 的口服液，是标签分别列出的产品身份。相同品牌或通用名不能使它们自行按 mg、片数或 mL 换算、补用、叠加或替代。", "en": "The 60 mg immediate-release tablet, 180 mg TIMESPAN extended-release tablet and oral solution containing 60 mg per 5 mL are separately listed product identities. A shared brand or generic name does not make them self-convertible, make-up interchangeable, combinable or substitutable by milligrams, tablets or millilitres." }, { "zh": "60 mg 即释片标签描述有四等分刻痕，180 mg TIMESPAN 标签描述无刻痕；这些是外观核对字段，不是网页批准任何人掰开、压碎、分装或按比例减量的指令。涉及准确片剂的处理须以现行标签、处方和药师/开方团队为准。", "en": "The 60 mg immediate-release tablet is described as quadrisect scored and the 180 mg TIMESPAN tablet as unscored. These are appearance-check fields, not permission from this webpage for anyone to split, crush, repackage or proportionally reduce a tablet. Handling the exact tablet must follow the current label, prescription and pharmacist/prescribing-team advice." }, { "zh": "口服液“60 mg/5 mL”是该液体的浓度身份信息，不是把片剂换算成家庭量匙或个人 mL 数的公式。应同时核对准确产品、标签、随附量取工具和开方信息；网页不生成换算或量取建议。", "en": "Oral-solution wording of “60 mg/5 mL” is a concentration identity field, not a formula for changing tablets into household-spoon or personal millilitre amounts. Check the exact product, label, supplied measuring device and prescribing information together; this page does not generate a conversion or measuring instruction." }, { "zh": "标签提示过量或不足的表现可能难以区分，并涉及严重无力、呼吸/吞咽困难、明显分泌物或严重胃肠道症状等紧急风险。出现急性、严重或进行性不适时，应优先使用当地紧急医疗支持；不要依据网页自行加量、补用、暂停或换成另一种产品。", "en": "The label notes that signs of too much or too little may be difficult to distinguish and addresses urgent risks including severe weakness, breathing/swallowing difficulty, marked secretions or serious gastrointestinal symptoms. With an acute, serious or progressive concern, prioritise local urgent medical support; do not self-increase, make up, pause or change product from this page." } ], "source": { "id": "src_fbe1797b72543cef", "label": "DailyMed（NLM）：MESTINON 溴吡斯的明溴化物当前美国公开标签（Bausch Health；SPL v20）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a851795e-b7a8-40c3-9922-5e79d3eb4d92", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "溴吡斯的明怎样起作用：标签描述其抑制胆碱酯酶，但机制不是个人调整依据", "en": "How pyridostigmine works: the label describes cholinesterase inhibition, not a basis for personal adjustment" }, "summary": { "zh": "DailyMed 标签将溴吡斯的明描述为口服活性胆碱酯酶抑制剂，可抑制乙酰胆碱的分解并帮助神经冲动传递。它解释的是标签中的药理路径，不判断任何人的症状原因、产品选择、片数、口服液毫升数、联用或调整方案。", "en": "The DailyMed label describes pyridostigmine as an orally active cholinesterase inhibitor that inhibits acetylcholine breakdown and helps nerve-impulse transmission. This explains a labelled pharmacologic pathway; it does not determine anyone's symptom cause, product choice, tablet count, oral-solution millilitres, combination or adjustment plan." }, "checks": [ { "zh": "“抑制胆碱酯酶”不是对任何无力、疲劳、眼睑、吞咽、呼吸或胃肠道症状的自我诊断，也不能替代由专业人员结合准确产品、病情和检查资料作出的判断。", "en": "“Cholinesterase inhibition” is not a self-diagnosis for weakness, fatigue, eyelid, swallowing, breathing or gastrointestinal symptoms, and cannot replace professional judgement based on the exact product, condition and clinical information." }, { "zh": "共享这一机制、相近通用名或同为口服产品，不使 MESTINON 的液体、即释片、缓释片或另一种神经肌肉相关药物可以自行叠加、轮换、按 mg 换算或替代。完整药单和现行标签必须一起复核。", "en": "A shared mechanism, similar generic name or oral route does not make MESTINON liquid, immediate-release tablets, extended-release tablets or another neuromuscular medicine self-combinable, alternatable, milligram-convertible or substitutable. The complete medicine list and current labels require joint review." }, { "zh": "机制页面不能处理突然或加重的无力、呼吸/吞咽困难、晕厥、严重分泌物或其他急性不适。出现这类问题时，应优先使用当地紧急医疗支持，而不是继续试验不同剂型或根据包装数字自行调整。", "en": "A mechanism page cannot manage sudden or worsening weakness, breathing/swallowing difficulty, fainting, severe secretions or another acute concern. With these problems, prioritise local urgent medical support rather than experimenting with forms or adjusting from package numbers." } ], "source": { "id": "src_fbe1797b72543cef", "label": "DailyMed（NLM）：MESTINON 溴吡斯的明溴化物当前美国公开标签（Clinical Pharmacology；Bausch Health）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a851795e-b7a8-40c3-9922-5e79d3eb4d92", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "Mestinon", "generic": "溴吡斯的明", "dosageFormClass": "口服溶液、即释片与缓释片：相同品牌与通用名不建立自行换算、替换或掰开关系（美国公开标签所列）" }, "labelSource": { "id": "src_fbe1797b72543cef", "label": "DailyMed（NLM）：MESTINON 溴吡斯的明溴化物当前美国公开标签（Bausch Health；SPL v20）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a851795e-b7a8-40c3-9922-5e79d3eb4d92", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "productRoutes": [ { "source": { "id": "src_fbe1797b72543cef", "label": "DailyMed（NLM）：MESTINON 溴吡斯的明溴化物当前美国公开标签（Bausch Health；SPL v20）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a851795e-b7a8-40c3-9922-5e79d3eb4d92", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "DailyMed 的 MESTINON（pyridostigmine bromide）美国公开标签同时列出 60 mg/5 mL 口服溶液、60 mg 即释片和 180 mg TIMESPAN 缓释片。页面帮助把商品名、通用名、准确剂型、标示量、NDC、包装与目标市场一起核对；不把包装数字变成个人毫升数、片数、时间表、联用、转换或停药方案。", "history": "当前公开标签将三种口服产品并列，而它们具有不同 NDC、每单位标示量和缓释属性。共享品牌或通用名不能证明口服液、即释片与缓释片可以自行互换、按 mg 换算、掰开或以一种形式补另一种。此页仅提供美国公开标签的阅读入口，不作其他市场或实际可得性结论。", "sourceDocuments": [ { "id": "src_fbe1797b72543cef", "label": "DailyMed（NLM）：MESTINON 溴吡斯的明溴化物当前美国公开标签（Bausch Health；SPL v20）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a851795e-b7a8-40c3-9922-5e79d3eb4d92", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_5ed30b676fbb9773", "label": "FDA Drugs@FDA 官方检索入口", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_lookup_entry", "documentKind": "regulatory_lookup", "market": "US", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } ], "applicationNumber": "NDA 009829（60 mg 片）/ NDA 011665（180 mg TIMESPAN）/ NDA 015193（口服溶液；均为当前 DailyMed 标签列示的产品记录）", "approvalTimeline": [ { "date": "1955", "title": { "zh": "60 mg 片的历史营销记录节点", "en": "Historical marketing-record node for the 60 mg tablet" }, "detail": { "zh": "当前 DailyMed 标签在 60 mg 片的 NDC 表中列示 NDA 009829 与 1955 年营销起始节点。本页把它作为该美国公开标签的历史产品记录，不据此推定其他市场状态。", "en": "The current DailyMed label lists NDA 009829 and a 1955 marketing-start node for the 60 mg tablet. This page treats it as a historical product-record entry in the U.S. public label, not as evidence for another market." }, "source": { "id": "src_fbe1797b72543cef", "label": "DailyMed：MESTINON 当前美国公开标签（SPL v20）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a851795e-b7a8-40c3-9922-5e79d3eb4d92", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, { "date": "1959", "title": { "zh": "180 mg TIMESPAN 的历史营销记录节点", "en": "Historical marketing-record node for 180 mg TIMESPAN" }, "detail": { "zh": "当前 DailyMed 标签在 180 mg TIMESPAN 的 NDC 表中列示 NDA 011665 与 1959 年营销起始节点。其缓释属性与 60 mg 即释片和口服液须分别核对。", "en": "The current DailyMed label lists NDA 011665 and a 1959 marketing-start node for 180 mg TIMESPAN. Its extended-release property must be checked separately from the 60 mg immediate-release tablet and oral solution." }, "source": { "id": "src_fbe1797b72543cef", "label": "DailyMed：MESTINON 当前美国公开标签（SPL v20）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a851795e-b7a8-40c3-9922-5e79d3eb4d92", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, { "date": "1965", "title": { "zh": "口服溶液的历史营销记录节点", "en": "Historical marketing-record node for the oral solution" }, "detail": { "zh": "当前 DailyMed 标签在口服溶液的 NDC 表中列示 NDA 015193 与 1965 年营销起始节点。60 mg/5 mL 是液体产品身份字段，不是换算指令。", "en": "The current DailyMed label lists NDA 015193 and a 1965 marketing-start node for the oral solution. 60 mg/5 mL is a liquid-product identity field, not a conversion instruction." }, "source": { "id": "src_fbe1797b72543cef", "label": "DailyMed：MESTINON 当前美国公开标签（SPL v20）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a851795e-b7a8-40c3-9922-5e79d3eb4d92", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, { "date": "2023-02-02", "title": { "zh": "DailyMed 当前 SPL v20 公开", "en": "Current SPL v20 published on DailyMed" }, "detail": { "zh": "DailyMed 的当前 MESTINON SPL v20 公开日期为 2023-02-02。本页将其作为来源版本信息，不据此说明实际可得性或个人用药结论。", "en": "DailyMed lists 2 February 2023 as the publication date for the current MESTINON SPL v20. This page uses it as source-version information, not as evidence of availability or an individual-use conclusion." }, "source": { "id": "src_fbe1797b72543cef", "label": "DailyMed：MESTINON 当前美国公开标签（SPL v20）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a851795e-b7a8-40c3-9922-5e79d3eb4d92", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "已链接当前标签与三个精确包装身份", "en": "Current label and three exact package identities linked" }, "detail": { "zh": "本页分别列示 60 mg 即释片、180 mg TIMESPAN 缓释片与 60 mg/5 mL 口服溶液；不由此建立实际在售、库存、个人用量或可自行替换结论。", "en": "This page separately lists the 60 mg immediate-release tablet, 180 mg TIMESPAN extended-release tablet and 60 mg/5 mL oral solution; it does not establish actual availability, stock, individual use or self-directed interchangeability." } }, { "market": { "zh": "中国大陆、欧盟、日本及其他市场", "en": "Mainland China, EU, Japan and other markets" }, "status": { "zh": "待逐项建立市场记录", "en": "Market record not established" }, "detail": { "zh": "不从美国公开标签推定当地商品名、批准、规格、包装、供应、原研关系或可替代性。", "en": "No local trade name, approval, strength, pack, supply, originator relationship or interchangeability is inferred from the U.S. public label." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "60 mg、180 mg TIMESPAN 和 60 mg/5 mL 能否只按毫克数互换？", "en": "Can 60 mg, 180 mg TIMESPAN and 60 mg/5 mL be exchanged from milligrams alone?" }, "answer": { "zh": "不能。它们分别对应即释片、缓释片和口服液的不同产品身份。完整品牌、剂型、标示量、NDC、标签版本和处方都需要一起由药师或开方团队核对。", "en": "No. They identify different product forms: an immediate-release tablet, extended-release tablet and oral solution. The complete brand, form, labelled amount, NDC, label version and prescription need joint review by a pharmacist or prescribing team." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "dosage-forms-are-part-of-medicine-identity", "how-to-read-a-drug-label" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/mestinon/", "en": "https://origindrug.com/en/drugs/mestinon/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "janumet", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-23", "status": "published_traceable_archive" }, "names": { "brand": "Janumet", "generic": "西格列汀/二甲双胍", "aliases": [ "sitagliptin metformin", "sitagliptin/metformin", "捷诺达", "sitagliptin / metformin hydrochloride" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "代谢", "sourceArchiveMarket": "美国 DailyMed 有日期公开标签（Merck；页面 2025-03-25 更新）。本页只展示两种准确 60 片瓶装：50 mg/500 mg（NDC 0006-0575-61）与 50 mg/1000 mg（NDC 0006-0577-61）；JANUMET XR、其他包装和其他市场必须分别核对。", "dosageFormClass": "西格列汀/盐酸二甲双胍复方薄膜衣口服片：每片 50 mg/500 mg 或 50 mg/1000 mg（本页分别展示两个 60 片瓶装）", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "2007（FDA 2022 标签所列美国初始批准）", "archiveSponsorText": "Merck / DailyMed（NLM）有日期美国公开标签；FDA 公开监管档案" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-janumet-sitagliptin-50mg-metformin-500mg-60-count-bottle-ndc-0006057561", "marketCode": "US", "labelVersion": { "zh": "DailyMed 美国有日期公开标签（Merck；页面 2025-03-25 更新）；仅为所引包装展示面，不代表供应", "en": "Dated U.S. DailyMed public label (Merck; page updated 25 Mar 2025); cited package panel only, not availability" }, "dosageForm": { "zh": "JANUMET 西格列汀/盐酸二甲双胍薄膜衣口服片", "en": "JANUMET sitagliptin/metformin hydrochloride film-coated oral tablet" }, "route": { "zh": "口服（标签产品身份字段）", "en": "oral (label product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 0006-0575-61", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片西格列汀 50 mg / 盐酸二甲双胍 500 mg；60 片瓶装", "en": "Sitagliptin 50 mg / metformin HCl 500 mg per tablet; 60-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=janumet-05.jpg&setid=d19c7ed0-ad5c-426e-b2df-722508f97d67", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "西格列汀", "en": "sitagliptin" }, "value": 50, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片复方中西格列汀的标签量；不是个人片数或换药规则", "en": "labelled sitagliptin amount in one combination tablet; not an individual's tablet count or switching rule" } }, { "ingredient": { "zh": "盐酸二甲双胍", "en": "metformin hydrochloride" }, "value": 500, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片复方中盐酸二甲双胍的标签量；不是个人片数或换药规则", "en": "labelled metformin HCl amount in one combination tablet; not an individual's tablet count or switching rule" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 60, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-23", "currentLabelDisplayed": false, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 60, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "浅粉色", "en": "light pink" }, "shape": { "zh": "胶囊形薄膜衣片；无刻痕", "en": "capsule-shaped film-coated tablet; unscored" }, "imprint": "575", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_e0f74693b5f0530f", "label": "DailyMed（NLM）：JANUMET 西格列汀/盐酸二甲双胍美国有日期公开标签（Merck；页面 2025-03-25 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d19c7ed0-ad5c-426e-b2df-722508f97d67", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-janumet-sitagliptin-50mg-metformin-1000mg-60-count-bottle-ndc-0006057761", "marketCode": "US", "labelVersion": { "zh": "DailyMed 美国有日期公开标签（Merck；页面 2025-03-25 更新）；仅为所引包装展示面，不代表供应", "en": "Dated U.S. DailyMed public label (Merck; page updated 25 Mar 2025); cited package panel only, not availability" }, "dosageForm": { "zh": "JANUMET 西格列汀/盐酸二甲双胍薄膜衣口服片", "en": "JANUMET sitagliptin/metformin hydrochloride film-coated oral tablet" }, "route": { "zh": "口服（标签产品身份字段）", "en": "oral (label product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 0006-0577-61", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片西格列汀 50 mg / 盐酸二甲双胍 1000 mg；60 片瓶装", "en": "Sitagliptin 50 mg / metformin HCl 1000 mg per tablet; 60-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=janumet-06.jpg&setid=d19c7ed0-ad5c-426e-b2df-722508f97d67", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "西格列汀", "en": "sitagliptin" }, "value": 50, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片复方中西格列汀的标签量；不是个人片数或换药规则", "en": "labelled sitagliptin amount in one combination tablet; not an individual's tablet count or switching rule" } }, { "ingredient": { "zh": "盐酸二甲双胍", "en": "metformin hydrochloride" }, "value": 1000, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片复方中盐酸二甲双胍的标签量；不是个人片数或换药规则", "en": "labelled metformin HCl amount in one combination tablet; not an individual's tablet count or switching rule" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 60, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-23", "currentLabelDisplayed": false, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 60, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "红色", "en": "red" }, "shape": { "zh": "胶囊形薄膜衣片；无刻痕", "en": "capsule-shaped film-coated tablet; unscored" }, "imprint": "577", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_e0f74693b5f0530f", "label": "DailyMed（NLM）：JANUMET 西格列汀/盐酸二甲双胍美国有日期公开标签（Merck；页面 2025-03-25 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d19c7ed0-ad5c-426e-b2df-722508f97d67", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-janumet-sitagliptin-50mg-metformin-500mg-60-count-bottle-ndc-0006057561", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=janumet-05.jpg&setid=d19c7ed0-ad5c-426e-b2df-722508f97d67", "alt": "JANUMET 西格列汀/盐酸二甲双胍美国 DailyMed 有日期公开标签中的 50 mg/500 mg、NDC 0006-0575-61、60 片瓶装展示面", "archiveMarket": "美国", "labelVersion": "页面 2025-03-25 更新；本图只对应所引有日期公开标签中的准确瓶装", "presentation": "JANUMET：每片西格列汀 50 mg / 盐酸二甲双胍 500 mg，NDC 0006-0575-61，60 片瓶装展示面。", "notice": "此图只对应美国 DailyMed 有日期公开标签中的 JANUMET、西格列汀 50 mg / 盐酸二甲双胍 500 mg、NDC 0006-0575-61 与 60 片瓶装。它只帮助核对两种成分、每片两组标签量、包装、外形线索和来源；不用于鉴定真伪，也不证明 50 mg/1000 mg、JANUMET XR、单方西格列汀/二甲双胍、其他包装、其他市场、当前可得性、原研身份、可替代性或任何个人使用方案。", "source": { "id": "src_e0f74693b5f0530f", "label": "DailyMed（NLM）：JANUMET 西格列汀/盐酸二甲双胍美国有日期公开标签（Merck；页面 2025-03-25 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d19c7ed0-ad5c-426e-b2df-722508f97d67", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "JANUMET 说明书放大阅读：一片里的两个成分，要分开核对", "en": "JANUMET label reading: two components in one tablet need separate checks" }, "summary": { "zh": "本模块用 FDA 2022 美国标签解释“50 mg/500 mg”“50 mg/1000 mg”这类复方标示的阅读方式；不把包装数字转化为个人服用数量或治疗方案。", "en": "This module uses the 2022 U.S. FDA label to explain combination labels such as “50 mg/500 mg” and “50 mg/1000 mg”; it does not turn package numbers into an individual's tablet count or treatment plan." }, "checks": [ { "zh": "复方片上的两个 mg 分别对应西格列汀和盐酸二甲双胍等不同成分的标示强度；不能把它读成一个总毫克数，也不能据此自行与单方二甲双胍或其他降糖药叠加。", "en": "The two mg values on a combination tablet identify stated strengths for different components such as sitagliptin and metformin HCl. Do not read them as one total milligram value or use them to self-add a separate metformin or other glucose-lowering medicine." }, { "zh": "该标签说明起始安排需要结合既往方案，并提到肾功能、脱水、感染、饮酒和含碘造影等情形需要专业人员评估。出现这些变化时，应联系负责团队核对实际产品，而不是临时自行加减或停药。", "en": "The label says starting use is based on the prior regimen and identifies kidney function, dehydration, infection, alcohol and iodinated contrast as situations needing professional assessment. With such changes, contact the responsible team to review the actual product rather than self-adjusting or stopping." }, { "zh": "如果同时使用胰岛素或促胰岛素分泌药，标签提示低血糖风险可能需要额外处理；这不是网络上可以统一规定的加减法。请记录所有药品名称、强度和实际服用时间，由医生或药师核对。", "en": "When insulin or an insulin secretagogue is also used, the label notes that hypoglycaemia risk may need extra management; this is not a universal online adjustment rule. Record every medicine name, strength and actual timing for a clinician or pharmacist to review." }, { "zh": "药盒颜色、片剂外观与两个数字只帮助定位待核对的产品，不能证明真伪、当前批准、是否为同一版本或是否适合另一位家人。每次应把商品名、两种成分、规格、剂型、目标市场和完整药单一起核对。", "en": "Package colour, tablet appearance and the two numbers only help locate a product for checking. They cannot authenticate it, establish current approval, show it is the same version or prove it suits another family member. Check brand name, both ingredients, strength, dosage form, target market and the complete medicine list together." }, { "zh": "JANUMET XR 是需单独核对的另一种剂型；本页的两款 JANUMET 60 片瓶装面板不能用来判定 XR、其他包装或其他市场产品。任何产品变化都应由医生或药师把实际药盒和处方逐项核对。", "en": "JANUMET XR is a separate dosage form that requires its own verification. The two JANUMET 60-tablet bottle panels on this page cannot establish the identity of XR, another package or a product in another market. Have a clinician or pharmacist review the actual pack and prescription item by item for any product change." } ], "source": { "id": "src_98492b07cb5b1b93", "label": "FDA：JANUMET 2022 美国处方信息（NDA 022044）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022044s052lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "西格列汀/二甲双胍怎样起作用：一部分减慢肠促胰岛素失活，另一部分影响肝脏和外周葡萄糖利用", "en": "How sitagliptin/metformin works: one part slows incretin inactivation and the other affects hepatic and peripheral glucose handling" }, "summary": { "zh": "FDA 标签将 JANUMET 描述为两种作用机制互补的降糖成分：西格列汀是 DPP-4 抑制剂，减慢肠促胰岛素激素失活；二甲双胍可减少肝脏葡萄糖生成、减少肠道葡萄糖吸收并提高外周胰岛素敏感性。它解释复方为何需要把两种成分一起核对，不决定个人血糖、肾功能、用量或是否应增减单方药。", "en": "The FDA label describes JANUMET as two glucose-lowering ingredients with complementary mechanisms: sitagliptin is a DPP-4 inhibitor that slows incretin-hormone inactivation; metformin can decrease hepatic glucose production and intestinal glucose absorption while improving peripheral insulin sensitivity. This explains why both components must be checked together; it does not decide an individual's glucose, kidney function, dose or whether to add or remove a single-ingredient medicine." }, "checks": [ { "zh": "“一片含两种成分”不表示可以把 JANUMET 与 JANUVIA、二甲双胍单方、其他 DPP-4、GLP-1、胰岛素或其他降糖产品自行叠加、轮换或替换。任何组合都需先把完整药单、实际包装和开方目的交由专业人员核对。", "en": "“Two components in one tablet” does not make JANUMET self-combinable, alternatable or substitutable with JANUVIA, single-ingredient metformin, another DPP-4 product, GLP-1, insulin or another glucose-lowering product. Any combination needs the complete medicine list, actual packs and prescribing purpose reviewed by professionals first." }, { "zh": "机制不能把 50 mg/500 mg、50 mg/1000 mg 或其他包装数字变成自行加减、掰分或从两种单方药拼凑复方的公式。两个数字分别属于两种成分，任何规格或产品变化都要回到现行标签与个人处方。", "en": "Mechanism cannot turn 50 mg/500 mg, 50 mg/1000 mg or numbers on another pack into a formula for self-adjustment, splitting or constructing a combination from two single-ingredient products. The two numbers belong to two components; any strength or product change must return to the current label and individual prescription." }, { "zh": "脱水、肾功能变化、感染、饮酒、含碘造影检查或低血糖相关不适等问题，不能从机制页面判断该如何处理。请带完整药单与实际包装联系当地医生、药师或需要时的紧急支持。", "en": "Dehydration, kidney-function changes, infection, alcohol, iodinated-contrast studies or symptoms related to low glucose cannot be managed from a mechanism page. Contact a local clinician, pharmacist or, when needed, urgent support with the complete medicine list and actual packs." } ], "source": { "id": "src_98492b07cb5b1b93", "label": "FDA：JANUMET 2022 美国处方信息（临床药理）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022044s052lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "Janumet", "generic": "西格列汀/二甲双胍", "dosageFormClass": "西格列汀/盐酸二甲双胍复方薄膜衣口服片：每片 50 mg/500 mg 或 50 mg/1000 mg（本页分别展示两个 60 片瓶装）" }, "labelSource": { "id": "src_98492b07cb5b1b93", "label": "FDA：JANUMET 2022 美国处方信息（NDA 022044）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022044s052lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "productRoutes": [ { "source": { "id": "src_98492b07cb5b1b93", "label": "FDA：JANUMET 2022 美国处方信息（NDA 022044）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022044s052lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_e0f74693b5f0530f", "label": "DailyMed（NLM）：JANUMET 西格列汀/盐酸二甲双胍美国有日期公开标签（Merck；页面 2025-03-25 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d19c7ed0-ad5c-426e-b2df-722508f97d67", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-23", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "美国 DailyMed 的 JANUMET 有日期公开标签列示西格列汀/盐酸二甲双胍复方薄膜衣口服片。本页将 50 mg/500 mg 与 50 mg/1000 mg 两种准确 60 片瓶装分开，帮助读者把两种成分、两组标签量、NDC、片剂外观和原始说明书一起核对；它不把包装数字转成个人片数、单方叠加、停用、换药或购买建议。", "history": "同一人拿到单方二甲双胍、单方西格列汀、JANUMET 或 JANUMET XR 时，不能仅凭“都治糖尿病”、品牌相似或看见相同的一个 mg 数字自行叠加、互换或按片数计算。应把所有实际药盒、处方、非处方药和补充剂交给药师或开方团队核对。", "sourceDocuments": [ { "id": "src_e0f74693b5f0530f", "label": "DailyMed（NLM）：JANUMET 西格列汀/盐酸二甲双胍美国有日期公开标签（Merck；页面 2025-03-25 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d19c7ed0-ad5c-426e-b2df-722508f97d67", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, { "id": "src_98492b07cb5b1b93", "label": "FDA：JANUMET 2022 美国处方信息（NDA 022044）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022044s052lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_5ed30b676fbb9773", "label": "FDA Drugs@FDA 官方检索入口", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_lookup_entry", "documentKind": "regulatory_lookup", "market": "US", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } ], "applicationNumber": "NDA 022044", "approvalTimeline": [ { "date": "2007", "title": { "zh": "FDA 标签所列美国初始批准年份", "en": "Initial U.S. approval year listed in the FDA label" }, "detail": { "zh": "本页链接的 FDA 标签档案列示 Initial U.S. Approval: 2007。该历史定位不等同于当前批准、可得性、持有人或其他市场状态。", "en": "The FDA label archive linked here lists Initial U.S. Approval: 2007. This historical locator is not a conclusion about current approval, availability, holder or another market." }, "source": { "id": "src_98492b07cb5b1b93", "label": "FDA: JANUMET prescribing information", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022044s052lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, { "date": "2022", "title": { "zh": "FDA 标签档案版本", "en": "FDA label archive version" }, "detail": { "zh": "本页链接 2022 的 FDA 标签档案作为可复核阅读入口。现行标签、规格、适应症和安全信息必须另行以目标市场当前文件核对。", "en": "This page links the 2022 FDA label archive as a traceable reading entry point. Current labeling, strength, indication and safety information require separate verification against the target market’s current document." }, "source": { "id": "src_98492b07cb5b1b93", "label": "FDA: JANUMET prescribing information", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022044s052lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "已链接公开标签档案", "en": "Public label archive linked" }, "detail": { "zh": "仅对应本页所列 FDA 文件。", "en": "Only the FDA document listed on this page is linked." } }, { "market": { "zh": "中国大陆、欧盟、日本", "en": "Mainland China, EU, Japan" }, "status": { "zh": "待逐项建立市场记录", "en": "Market record not established" }, "detail": { "zh": "不从美国标签档案推定当地批准、持有人、规格、供应或可售资格。", "en": "No local approval, holder, strength, supply or sale-eligibility conclusion is inferred from the U.S. label archive." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "标签档案能代表现在的产品信息吗？", "en": "Does a label archive represent current product information?" }, "answer": { "zh": "不能自动代表。档案用于定位来源；需要以目标市场的现行官方标签逐项复核。", "en": "Not automatically. The archive locates a source; each point needs verification against the target market’s current official label." } }, { "question": { "zh": "为什么这里不展示价格或原研/仿制结论？", "en": "Why are price and originator/generic conclusions not shown?" }, "answer": { "zh": "这些结论需要产品、剂型、规格、包装、市场、日期和原始记录分别齐全并经人工审核；单一标签文件不足以支持。", "en": "Those conclusions require separately complete and human-reviewed product, dosage-form, strength, pack, market, date and primary-record fields; one label file is insufficient." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "how-to-read-a-drug-label", "regulatory-sources-first" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/janumet/", "en": "https://origindrug.com/en/drugs/janumet/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "spiriva-handihaler", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-17", "status": "published_traceable_archive" }, "names": { "brand": "Spiriva HandiHaler", "generic": "噻托溴铵", "aliases": [ "tiotropium", "tiotropium bromide", "思力华" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "呼吸系统", "sourceArchiveMarket": "美国公开监管标签档案", "dosageFormClass": "吸入粉雾剂胶囊及专用装置（FDA 2025 标签及 DailyMed 2025-11 公开标签所列）", "dosageFormClassCode": "inhaled_device", "route": "经口吸入", "routeCode": "inhalation", "historicalApprovalEntry": "2004（FDA 2025 标签所列美国初始批准）", "archiveSponsorText": "FDA / DailyMed 公开监管标签档案" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [ "SPIRIVA RESPIMAT", "RESPIMAT", "tiotropium inhalation spray", "STIOLTO RESPIMAT", "COMBIVENT RESPIMAT" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-spiriva-handihaler-tiotropium-bromide-inhalation-powder-capsule-18mcg-ndc-0597-0075-41", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v28（2025-11-10 生效）", "en": "DailyMed SPL v28 (effective 10 Nov 2025)" }, "dosageForm": { "zh": "SPIRIVA HANDIHALER 噻托溴铵吸入粉雾剂胶囊＋专用 HandiHaler 装置", "en": "SPIRIVA HANDIHALER tiotropium bromide inhalation powder capsule + dedicated HandiHaler device" }, "route": { "zh": "仅可通过 HandiHaler 经口吸入；不可吞服", "en": "oral inhalation through the HandiHaler only; do not swallow" }, "routeCodes": [ "inhalation" ], "productCode": "NDC 0597-0075-41", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_inhalation_capsule", "primaryDisplay": { "zh": "每粒吸入用胶囊含噻托溴铵 18 mcg；30 粒＋1 个 HandiHaler 装置（仅供吸入，不可吞服）", "en": "Tiotropium bromide 18 mcg per inhalation capsule; 30 capsules + 1 HandiHaler device (for inhalation only, not swallowing)" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=spiriva-29.jpg&setid=820839ef-e53d-47e8-a3b9-d911ff92e6a9&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "噻托溴铵（每粒吸入用胶囊）", "en": "tiotropium bromide (per inhalation capsule)" }, "value": 18, "unit": "mcg", "basisCode": "per_inhalation_capsule", "basisLabel": { "zh": "每粒吸入用胶囊的标签标示量；不是口服剂量、个人胶囊数或操作指令", "en": "Labelled amount per inhalation capsule; not an oral dose, individual's capsule count or device instruction" } } ], "concentration": null, "container": { "typeCode": "carton_with_device", "typeLabel": { "zh": "纸盒：泡罩胶囊＋专用装置", "en": "carton: blister capsules + dedicated device" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "粒吸入用胶囊", "en": "inhalation capsules" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-26", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 30, "unit": { "zh": "粒吸入用胶囊／盒；含 1 个 HandiHaler 装置", "en": "inhalation capsules per carton; includes 1 HandiHaler device" } }, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_adbab5875f0d9be3", "label": "DailyMed（NLM）：SPIRIVA HANDIHALER 18 mcg 吸入粉雾剂胶囊、30 粒与 HandiHaler 装置当前美国公开标签（SPL v28）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?lang=en&setid=820839ef-e53d-47e8-a3b9-d911ff92e6a9", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": null, "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=spiriva-29.jpg&setid=820839ef-e53d-47e8-a3b9-d911ff92e6a9&type=img", "alt": "SPIRIVA HANDIHALER 美国公开标签的 18 mcg、30 粒胶囊与 1 个 HandiHaler 装置纸盒展示面", "archiveMarket": "美国", "labelVersion": "DailyMed SPL v28，2025-11-10 生效", "presentation": "18 mcg 吸入粉雾剂胶囊、30 粒（3 板各 10 粒）与 1 个 HandiHaler 装置纸盒，NDC 0597-0075-41。", "notice": "此为勃林格殷格翰在美国 DailyMed 现行公开标签中的准确展示面，只帮助核对品牌、噻托溴铵、18 mcg 吸入用胶囊、30 粒/3 板、HandiHaler 装置和 NDC；胶囊不是吞服用。不用于鉴定真伪，也不证明其他包装、其他市场标签、原研身份、目标市场批准或可售资格。", "source": { "id": "src_adbab5875f0d9be3", "label": "DailyMed（NLM）：SPIRIVA HANDIHALER 公开标签（2025-11 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?lang=en&setid=820839ef-e53d-47e8-a3b9-d911ff92e6a9", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "SPIRIVA HANDIHALER 说明书放大阅读：胶囊是吸入用，不是吞服用", "en": "SPIRIVA HANDIHALER label reading: the capsule is for inhalation, not swallowing" }, "summary": { "zh": "本模块以 FDA 2025 美国标签为阅读入口，解释该产品的胶囊、粉雾和 HandiHaler 装置之间的关系；它不替代个人吸入技术培训或急性呼吸症状处置。", "en": "This module uses the 2025 U.S. FDA label as a reading entry point, explaining the relationship between its capsule, powder and HandiHaler device; it does not replace individual inhaler-technique training or management of acute breathing symptoms." }, "checks": [ { "zh": "FDA 标签明确说明：SPIRIVA 胶囊只用于通过 HandiHaler 装置经口吸入，不应吞服。看到“18 mcg 胶囊”不能把它理解成口服药片或与任何口服胶囊互换。", "en": "The FDA label explicitly says SPIRIVA capsules are only for oral inhalation through the HandiHaler device and must not be swallowed. Seeing an “18 mcg capsule” does not make it an oral medicine or interchangeable with any swallowed capsule." }, { "zh": "标签列有产品特定的装置操作信息；本页不复述或生成具体吸入次数、装置步骤或个人操作。不要把其他吸入器、雾化器或“相似胶囊”的操作套用到这个产品；请药师或临床人员面对实际装置示范。", "en": "The label contains product-specific device information. This page does not repeat or generate an inhalation count, device steps or individual-use instructions. Do not apply steps for another inhaler, nebuliser or “similar capsule” to this product; ask a pharmacist or clinician to demonstrate with the actual device." }, { "zh": "该标签明确其为长期维持治疗，不用于缓解急性支气管痉挛。突然或加重的呼吸困难不适合通过自行多用、换用或等待网页回复处理，应按当地急救和医疗团队指引处置。", "en": "The label describes long-term maintenance treatment and says it is not for relief of acute bronchospasm. Sudden or worsening breathing difficulty is not a situation for self-escalation, substitution or waiting for a webpage; follow local emergency and care-team guidance." }, { "zh": "胶囊颜色、泡罩、装置外观和“18 mcg”仅是本产品的核对线索，不能验证真伪、判断是否为 RESPIMAT 或其他噻托溴铵产品，也不能证明可替代性。应把实际包装、装置、商品名和目标市场一起交由药师核对。", "en": "Capsule colour, blister, device appearance and “18 mcg” are only identification clues for this product. They cannot authenticate it, show it is RESPIMAT or another tiotropium product, or prove interchangeability. Have a pharmacist check the actual pack, device, brand name and target market together." } ], "source": { "id": "src_3cae0a2e7f3979e2", "label": "FDA：SPIRIVA HANDIHALER 2025 美国处方信息（NDA 021395）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/021395Orig1s078lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "噻托溴铵怎样起作用：它在气道平滑肌阻断 M3 毒蕈碱受体", "en": "How tiotropium works: it blocks M3 muscarinic receptors in airway smooth muscle" }, "summary": { "zh": "FDA 标签将噻托溴铵描述为长效抗毒蕈碱药。在气道中，它通过抑制平滑肌上的 M3 受体发挥支气管扩张相关作用；吸入后的这一作用主要发生在局部。机制解释的是作用路径，不能决定个人是否适用、吸入技术、装置操作、是否需要急救药或呼吸困难时应如何处理。", "en": "The FDA label describes tiotropium as a long-acting antimuscarinic agent. In the airways, it has bronchodilation-related effects through inhibition of M3 receptors on smooth muscle, and this effect after inhalation is predominantly local. Mechanism explains an action pathway; it cannot determine individual suitability, inhalation technique, device operation, whether a rescue medicine is needed or what to do with breathing difficulty." }, "checks": [ { "zh": "“抗胆碱能”或“支气管扩张”不表示 SPIRIVA HANDIHALER 能与另一种吸入器、雾化液、口服胶囊或其他同类药自行叠加、替换或按微克数换算。产品、装置、给药途径和完整药单必须一起核对。", "en": "“Anticholinergic” or “bronchodilation” does not make SPIRIVA HANDIHALER self-combinable, substitutable or convertible by micrograms with another inhaler, nebuliser solution, swallowed capsule or related medicine. Product, device, route and the complete medicine list must be checked together." }, { "zh": "M3 受体机制不会把“胶囊”变成口服用药，也不会说明可以把粉末倒出、改用其他装置或凭经验改变操作。该产品的胶囊、粉末与 HandiHaler 是同一个给药系统的一部分；需要现场示范或核对时，应带实际装置咨询药师或临床人员。", "en": "An M3-receptor mechanism does not turn a “capsule” into a swallowed medicine, or show that powder can be emptied, another device used or operation changed from experience. The capsule, powder and HandiHaler are parts of one delivery system; with a need for demonstration or checking, take the actual device to a pharmacist or clinician." }, { "zh": "机制不能把维持治疗产品变成突然气促、喘鸣或胸闷时的自行加量方案。出现急性或加重的呼吸困难，应按所在地的急救与医疗渠道及时处理，而不是等待网页给出装置或药物调整。", "en": "Mechanism cannot turn a maintenance product into a self-escalation plan for sudden breathlessness, wheeze or chest tightness. For acute or worsening breathing difficulty, use local emergency and medical pathways promptly rather than wait for a webpage device or medicine adjustment." } ], "source": { "id": "src_3cae0a2e7f3979e2", "label": "FDA：SPIRIVA HANDIHALER 2025 美国处方信息（临床药理）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/021395Orig1s078lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "Spiriva HandiHaler", "generic": "噻托溴铵", "dosageFormClass": "吸入粉雾剂胶囊及专用装置（FDA 2025 标签及 DailyMed 2025-11 公开标签所列）" }, "labelSource": { "id": "src_3cae0a2e7f3979e2", "label": "FDA：SPIRIVA HANDIHALER 2025 美国处方信息（NDA 021395）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/021395Orig1s078lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "productRoutes": [ { "source": { "id": "src_3cae0a2e7f3979e2", "label": "FDA：SPIRIVA HANDIHALER 2025 美国处方信息（NDA 021395）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/021395Orig1s078lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_adbab5875f0d9be3", "label": "DailyMed（NLM）：SPIRIVA HANDIHALER 公开标签（2025-11 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?lang=en&setid=820839ef-e53d-47e8-a3b9-d911ff92e6a9", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "FDA 的 SPIRIVA HANDIHALER（tiotropium bromide）2025 美国标签将其列为通过专用 HandiHaler 装置使用的吸入粉雾剂胶囊。它不是口服吞咽胶囊；产品形式和装置必须作为完整身份一起核对。", "history": "“胶囊”一词不等于所有产品都经口吞服。吸入装置、使用方法与急性症状处置均不能仅凭外观、药名或上一种吸入产品推断。", "sourceDocuments": [ { "id": "src_3cae0a2e7f3979e2", "label": "FDA：SPIRIVA HANDIHALER 2025 美国处方信息（NDA 021395）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/021395Orig1s078lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_adbab5875f0d9be3", "label": "DailyMed（NLM）：SPIRIVA HANDIHALER 公开标签（2025-11 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?lang=en&setid=820839ef-e53d-47e8-a3b9-d911ff92e6a9", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_5ed30b676fbb9773", "label": "FDA Drugs@FDA 官方检索入口", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_lookup_entry", "documentKind": "regulatory_lookup", "market": "US", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } ], "applicationNumber": "NDA 021395", "approvalTimeline": [ { "date": "2004", "title": { "zh": "FDA 标签所列美国初始批准年份", "en": "Initial U.S. approval year listed in the FDA label" }, "detail": { "zh": "本页链接的 FDA 标签档案列示 Initial U.S. Approval: 2004。该历史定位不等同于当前批准、可得性、持有人或其他市场状态。", "en": "The FDA label archive linked here lists Initial U.S. Approval: 2004. This historical locator is not a conclusion about current approval, availability, holder or another market." }, "source": { "id": "src_3cae0a2e7f3979e2", "label": "FDA: SPIRIVA HANDIHALER prescribing information", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/021395Orig1s078lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, { "date": "2025", "title": { "zh": "FDA 标签档案版本", "en": "FDA label archive version" }, "detail": { "zh": "本页链接 2025 的 FDA 标签档案作为可复核阅读入口。现行标签、规格、适应症和安全信息必须另行以目标市场当前文件核对。", "en": "This page links the 2025 FDA label archive as a traceable reading entry point. Current labeling, strength, indication and safety information require separate verification against the target market’s current document." }, "source": { "id": "src_3cae0a2e7f3979e2", "label": "FDA: SPIRIVA HANDIHALER prescribing information", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/021395Orig1s078lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "已链接公开标签档案", "en": "Public label archive linked" }, "detail": { "zh": "仅对应本页所列 FDA 文件。", "en": "Only the FDA document listed on this page is linked." } }, { "market": { "zh": "中国大陆、欧盟、日本", "en": "Mainland China, EU, Japan" }, "status": { "zh": "待逐项建立市场记录", "en": "Market record not established" }, "detail": { "zh": "不从美国标签档案推定当地批准、持有人、规格、供应或可售资格。", "en": "No local approval, holder, strength, supply or sale-eligibility conclusion is inferred from the U.S. label archive." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "标签档案能代表现在的产品信息吗？", "en": "Does a label archive represent current product information?" }, "answer": { "zh": "不能自动代表。档案用于定位来源；需要以目标市场的现行官方标签逐项复核。", "en": "Not automatically. The archive locates a source; each point needs verification against the target market’s current official label." } }, { "question": { "zh": "为什么这里不展示价格或原研/仿制结论？", "en": "Why are price and originator/generic conclusions not shown?" }, "answer": { "zh": "这些结论需要产品、剂型、规格、包装、市场、日期和原始记录分别齐全并经人工审核；单一标签文件不足以支持。", "en": "Those conclusions require separately complete and human-reviewed product, dosage-form, strength, pack, market, date and primary-record fields; one label file is insufficient." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "how-to-read-a-drug-label", "regulatory-sources-first" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/spiriva-handihaler/", "en": "https://origindrug.com/en/drugs/spiriva-handihaler/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "spiriva-respimat", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-22", "status": "published_traceable_archive" }, "names": { "brand": "Spiriva Respimat", "generic": "噻托溴铵", "aliases": [ "SPIRIVA RESPIMAT", "Spiriva Respimat", "tiotropium bromide inhalation spray" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "呼吸系统", "sourceArchiveMarket": "美国 SPIRIVA RESPIMAT 当前公开标签（DailyMed SPL v16，2026-08-19 发布）", "dosageFormClass": "SPIRIVA RESPIMAT 定量吸入喷雾剂：每次按压 1.25 mcg 或 2.5 mcg；专用吸入器与药筒系统（DailyMed SPL v16 所列）", "dosageFormClassCode": "inhaled_device", "route": "经口吸入", "routeCode": "inhalation", "historicalApprovalEntry": "2004（当前 DailyMed 标签所列美国初始批准）", "archiveSponsorText": "Boehringer Ingelheim Pharmaceuticals, Inc. / DailyMed（NLM）当前美国公开标签" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [ "SPIRIVA HANDIHALER", "HANDIHALER", "18 mcg capsule", "18 mcg inhalation powder", "STIOLTO RESPIMAT", "COMBIVENT RESPIMAT" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-spiriva-respimat-tiotropium-1-25mcg-60-actuations-ndc-0597-0160-61", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v16（2026-08-19 发布）", "en": "DailyMed SPL v16 (published 19 Aug 2026)" }, "dosageForm": { "zh": "SPIRIVA RESPIMAT 定量吸入喷雾剂；专用吸入器与药筒系统", "en": "SPIRIVA RESPIMAT metered inhalation spray; dedicated inhaler-and-cartridge system" }, "route": { "zh": "经口吸入", "en": "oral inhalation" }, "routeCodes": [ "oral_inhalation" ], "productCode": "NDC 0597-0160-61", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_actuation", "primaryDisplay": { "zh": "每次按压标签标示噻托溴铵 1.25 mcg；1 个 RESPIMAT 吸入器＋1 个专用药筒（60 次标签按压）", "en": "Tiotropium 1.25 mcg per labelled actuation; one RESPIMAT inhaler plus one dedicated cartridge (60 labelled actuations)" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=7b656b14-fcaa-2741-f6f0-e0be48971c02&name=spiriva-16.jpg", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "噻托溴铵", "en": "tiotropium" }, "value": 1.25, "unit": "mcg", "basisCode": "per_actuation", "basisLabel": { "zh": "每次按压的标签成分标示；不是个人使用次数或方案", "en": "labelled ingredient amount per actuation; not an individual's use count or regimen" } } ], "concentration": null, "container": { "typeCode": "metered_inhaler_with_cartridge", "typeLabel": { "zh": "RESPIMAT 吸入器与专用铝制药筒系统", "en": "RESPIMAT inhaler with dedicated aluminium cartridge system" }, "fill": null, "countPerPackage": 1, "countUnit": { "zh": "系统/纸盒", "en": "system per carton" }, "unitsPerContainer": { "count": 60, "unit": { "zh": "次标签按压", "en": "labelled actuations" } } }, "deliveryDevice": { "typeCode": "respimat_metered_inhaler", "name": { "zh": "RESPIMAT 吸入器", "en": "RESPIMAT inhaler" } }, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-22", "currentLabelDisplayed": true, "ndcDirectoryListed": false, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 1, "unit": { "zh": "吸入器＋药筒/纸盒（60 次标签按压）", "en": "inhaler plus cartridge per carton (60 labelled actuations)" } }, "physicalClues": { "color": { "zh": "蓝色 帽与对应标签面板", "en": "blue cap and corresponding label panel" }, "shape": { "zh": "灰色圆柱形装置、透明底座；专用药筒", "en": "grey cylindrical device with clear base; dedicated cartridge" }, "imprint": null, "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_3d041c6141f7a895", "label": "DailyMed（NLM）：SPIRIVA RESPIMAT 噻托溴铵定量吸入喷雾剂当前美国公开标签（Boehringer Ingelheim；SPL v16，2026-08-19 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=7b656b14-fcaa-2741-f6f0-e0be48971c02", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-spiriva-respimat-tiotropium-2-5mcg-60-actuations-ndc-0597-0100-61", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v16（2026-08-19 发布）", "en": "DailyMed SPL v16 (published 19 Aug 2026)" }, "dosageForm": { "zh": "SPIRIVA RESPIMAT 定量吸入喷雾剂；专用吸入器与药筒系统", "en": "SPIRIVA RESPIMAT metered inhalation spray; dedicated inhaler-and-cartridge system" }, "route": { "zh": "经口吸入", "en": "oral inhalation" }, "routeCodes": [ "oral_inhalation" ], "productCode": "NDC 0597-0100-61", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_actuation", "primaryDisplay": { "zh": "每次按压标签标示噻托溴铵 2.5 mcg；1 个 RESPIMAT 吸入器＋1 个专用药筒（60 次标签按压）", "en": "Tiotropium 2.5 mcg per labelled actuation; one RESPIMAT inhaler plus one dedicated cartridge (60 labelled actuations)" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=7b656b14-fcaa-2741-f6f0-e0be48971c02&name=spiriva-17.jpg", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "噻托溴铵", "en": "tiotropium" }, "value": 2.5, "unit": "mcg", "basisCode": "per_actuation", "basisLabel": { "zh": "每次按压的标签成分标示；不是个人使用次数或方案", "en": "labelled ingredient amount per actuation; not an individual's use count or regimen" } } ], "concentration": null, "container": { "typeCode": "metered_inhaler_with_cartridge", "typeLabel": { "zh": "RESPIMAT 吸入器与专用铝制药筒系统", "en": "RESPIMAT inhaler with dedicated aluminium cartridge system" }, "fill": null, "countPerPackage": 1, "countUnit": { "zh": "系统/纸盒", "en": "system per carton" }, "unitsPerContainer": { "count": 60, "unit": { "zh": "次标签按压", "en": "labelled actuations" } } }, "deliveryDevice": { "typeCode": "respimat_metered_inhaler", "name": { "zh": "RESPIMAT 吸入器", "en": "RESPIMAT inhaler" } }, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-22", "currentLabelDisplayed": true, "ndcDirectoryListed": false, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 1, "unit": { "zh": "吸入器＋药筒/纸盒（60 次标签按压）", "en": "inhaler plus cartridge per carton (60 labelled actuations)" } }, "physicalClues": { "color": { "zh": "水蓝色 帽与对应标签面板", "en": "aqua cap and corresponding label panel" }, "shape": { "zh": "灰色圆柱形装置、透明底座；专用药筒", "en": "grey cylindrical device with clear base; dedicated cartridge" }, "imprint": null, "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_3d041c6141f7a895", "label": "DailyMed（NLM）：SPIRIVA RESPIMAT 噻托溴铵定量吸入喷雾剂当前美国公开标签（Boehringer Ingelheim；SPL v16，2026-08-19 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=7b656b14-fcaa-2741-f6f0-e0be48971c02", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-spiriva-respimat-tiotropium-2-5mcg-60-actuations-ndc-0597-0100-61", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=7b656b14-fcaa-2741-f6f0-e0be48971c02&name=spiriva-17.jpg", "alt": "SPIRIVA RESPIMAT 噻托溴铵 2.5 mcg 每次按压、60 次标签按压、NDC 0597-0100-61 在美国 DailyMed 当前公开标签中的纸盒展示面", "archiveMarket": "美国", "labelVersion": "DailyMed SPL v16（2026-08-19 发布）", "presentation": "SPIRIVA RESPIMAT 噻托溴铵定量吸入喷雾剂：每次按压 2.5 mcg；1 个 RESPIMAT 吸入器＋1 个专用药筒；60 次标签按压；NDC 0597-0100-61。", "notice": "此图只对应美国 DailyMed SPL v16 中 SPIRIVA RESPIMAT 2.5 mcg 每次按压、NDC 0597-0100-61、60 次标签按压的专用吸入器＋药筒纸盒。它只帮助核对品牌、成分、按压标示量、装置、药筒、包装和来源；不用于鉴定真伪，也不证明 1.25 mcg、HandiHaler 胶囊、其他 RESPIMAT 产品、其他市场标签、原研身份、目标市场批准、供应或可售资格。", "source": { "id": "src_3d041c6141f7a895", "label": "DailyMed（NLM）：SPIRIVA RESPIMAT 噻托溴铵定量吸入喷雾剂当前美国公开标签（Boehringer Ingelheim；SPL v16，2026-08-19 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=7b656b14-fcaa-2741-f6f0-e0be48971c02", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "SPIRIVA RESPIMAT 说明书放大阅读：先核对喷雾装置与药筒，再看每次按压的标示量", "en": "SPIRIVA RESPIMAT label reading: check the spray device and cartridge before the per-actuation label amount" }, "summary": { "zh": "本模块以美国 DailyMed SPL v16 当前公开标签为入口，帮助分辨 SPIRIVA RESPIMAT、噻托溴铵、每次按压标示量、60 次标签按压、专用吸入器和专用药筒。它不复述任何人的操作步骤、按压次数、间隔、漏用处理、加用、替换或急性呼吸处理方案。", "en": "This module uses the current U.S. DailyMed SPL v16 label to distinguish SPIRIVA RESPIMAT, tiotropium, the labelled amount per actuation, 60 labelled actuations, the dedicated inhaler and its dedicated cartridge. It does not reproduce anyone's device steps, actuation count, interval, missed-use action, escalation, substitution or acute-breathing plan." }, "checks": [ { "zh": "“1.25 mcg／2.5 mcg 每次按压”是喷雾装置中一次按压的标签身份字段，不是网页给任何人计算全天应按几次的答案。应同时核对准确产品名、帽色、NDC、吸入器、药筒、目标市场和处方标签。", "en": "“1.25 mcg / 2.5 mcg per actuation” is a label-identity field for one actuation from this spray device, not a webpage answer to how many times anyone should use it in a day. Check the exact product name, cap colour, NDC, inhaler, cartridge, target market and prescription label together." }, { "zh": "标签明确药筒只供 SPIRIVA RESPIMAT 吸入器使用，不应和其他 RESPIMAT 装置产品混用。相近的装置名、共同成分、都写“吸入”或都属于同一品牌家族，都不能证明装置、药筒或规格可自行替换。", "en": "The label says the cartridge is only for the SPIRIVA RESPIMAT inhaler and is not to be interchanged with another RESPIMAT device product. Similar device names, a shared ingredient, both saying “inhalation,” or the same brand family do not establish self-interchangeability of a device, cartridge or strength." }, { "zh": "SPIRIVA HANDIHALER 是粉雾剂胶囊配 HandiHaler 装置；RESPIMAT 是喷雾吸入器配药筒。HandiHaler 的“18 mcg 胶囊”不是 RESPIMAT 的药筒，也不是口服胶囊；看到相同通用名或微克数字不能推导换用。", "en": "SPIRIVA HANDIHALER is an inhalation-powder capsule with a HandiHaler device; RESPIMAT is a spray inhaler with a cartridge. A HandiHaler “18 mcg capsule” is neither a RESPIMAT cartridge nor a swallowed capsule, and a shared generic name or microgram number does not establish a switch." }, { "zh": "标签将本产品与急性支气管痉挛的即时缓解区分开来。突然或加重的气促、喘鸣、胸闷或不确定如何使用装置时，应按当地紧急医疗渠道和既有照护计划处理，并携带实际装置与完整药单请药师或临床人员核对。", "en": "The label distinguishes this product from immediate relief of acute bronchospasm. Sudden or worsening breathlessness, wheeze, chest tightness or uncertainty about the device needs local urgent-care pathways and an existing care plan, with the actual device and full medicine list reviewed by a pharmacist or clinician." } ], "source": { "id": "src_3d041c6141f7a895", "label": "DailyMed（NLM）：SPIRIVA RESPIMAT 噻托溴铵定量吸入喷雾剂当前美国公开标签（Boehringer Ingelheim；SPL v16，2026-08-19 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=7b656b14-fcaa-2741-f6f0-e0be48971c02", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "噻托溴铵怎样起作用：它是长效抗毒蕈碱药，作用于气道平滑肌的 M3 受体", "en": "How tiotropium works: it is a long-acting antimuscarinic medicine acting at M3 receptors in airway smooth muscle" }, "summary": { "zh": "当前标签将噻托溴铵描述为抗胆碱能支气管扩张剂；在气道中，它通过抑制平滑肌上的 M3 受体产生支气管扩张相关作用。机制解释的是作用路径，不判断某个人是否适合、需要何种装置、是否应联用其他吸入药，或出现症状时应如何自行处理。", "en": "The current label describes tiotropium as an anticholinergic bronchodilator; in the airways it has bronchodilation-related effects through inhibition of M3 receptors on smooth muscle. Mechanism explains an action pathway, not whether an individual is suitable, which device is needed, whether another inhaler should be combined, or how to self-manage symptoms." }, "checks": [ { "zh": "“抗胆碱能”是核对同类药和完整药单时的一个线索，不表示可以把 RESPIMAT 与其他抗胆碱能吸入药、口服药、贴剂或眼用药自行叠加、轮换或换算。请把所有实际药品和装置交由药师或医生逐项复核。", "en": "“Anticholinergic” is one clue for reviewing related medicines and the complete medicine list; it does not permit self-combining, alternating or converting RESPIMAT with another anticholinergic inhaler, oral medicine, patch or eye medicine. Have a pharmacist or clinician review every actual medicine and device." }, { "zh": "M3 受体机制不能让相同成分的 HandiHaler 胶囊、RESPIMAT 药筒、其他喷雾装置或其他市场产品变成同一身份。产品形态、药筒与装置配对、标签版本、市场和处方目的都需要一起核对。", "en": "An M3-receptor mechanism does not make a same-ingredient HandiHaler capsule, RESPIMAT cartridge, another spray device or another-market product the same identity. Product form, cartridge-device pairing, label version, market and prescribing purpose all need to be checked together." }, { "zh": "眼痛、视物模糊、排尿困难、严重过敏样反应或呼吸症状变化等情况，不能从机制页面推断自行增减、停用或换装置。请依据当地紧急医疗渠道和专业人员建议处理。", "en": "Eye pain, blurred vision, difficulty passing urine, a serious allergy-like reaction or changing breathing symptoms cannot be used with a mechanism page to decide self-escalation, stopping or changing devices. Use local urgent-care pathways and professional advice." } ], "source": { "id": "src_3d041c6141f7a895", "label": "DailyMed（NLM）：SPIRIVA RESPIMAT 噻托溴铵定量吸入喷雾剂当前美国公开标签（Boehringer Ingelheim；SPL v16，2026-08-19 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=7b656b14-fcaa-2741-f6f0-e0be48971c02", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "Spiriva Respimat", "generic": "噻托溴铵", "dosageFormClass": "SPIRIVA RESPIMAT 定量吸入喷雾剂：每次按压 1.25 mcg 或 2.5 mcg；专用吸入器与药筒系统（DailyMed SPL v16 所列）" }, "labelSource": { "id": "src_3d041c6141f7a895", "label": "DailyMed（NLM）：SPIRIVA RESPIMAT 噻托溴铵定量吸入喷雾剂当前美国公开标签（Boehringer Ingelheim；SPL v16，2026-08-19 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=7b656b14-fcaa-2741-f6f0-e0be48971c02", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" }, "productRoutes": [ { "source": { "id": "src_3d041c6141f7a895", "label": "DailyMed（NLM）：SPIRIVA RESPIMAT 噻托溴铵定量吸入喷雾剂当前美国公开标签（Boehringer Ingelheim；SPL v16，2026-08-19 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=7b656b14-fcaa-2741-f6f0-e0be48971c02", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-22", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-22", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "美国 DailyMed 的 SPIRIVA RESPIMAT（tiotropium bromide inhalation spray）当前公开标签将其定义为专用 RESPIMAT 吸入器与铝制药筒组成的定量吸入喷雾系统。本页分别记录 1.25 mcg 与 2.5 mcg 每次按压、各自 NDC、60 次标签按压的两张准确包装面板；不把任何包装数字转成个人应按几次、何时按、能否加用或换用的结论。", "history": "SPIRIVA RESPIMAT 与 SPIRIVA HANDIHALER 都含噻托溴铵，但标签产品形态不同：前者是定量喷雾吸入器＋专用药筒，后者是粉雾剂胶囊＋HandiHaler 装置。相同品牌家族、成分或微克数字不建立自行转换、叠加或替代关系。", "sourceDocuments": [ { "id": "src_3d041c6141f7a895", "label": "DailyMed（NLM）：SPIRIVA RESPIMAT 噻托溴铵定量吸入喷雾剂当前美国公开标签（Boehringer Ingelheim；SPL v16，2026-08-19 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=7b656b14-fcaa-2741-f6f0-e0be48971c02", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" }, { "id": "src_5ed30b676fbb9773", "label": "FDA Drugs@FDA 官方检索入口", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_lookup_entry", "documentKind": "regulatory_lookup", "market": "US", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } ], "applicationNumber": "DailyMed SPL setid 7b656b14-fcaa-2741-f6f0-e0be48971c02（SPL v16）", "approvalTimeline": [ { "date": "2004", "title": { "zh": "当前标签所列美国初始批准年份", "en": "Initial U.S. approval year listed in the current label" }, "detail": { "zh": "当前 SPIRIVA RESPIMAT 标签列示 Initial U.S. Approval: 2004。该年份只定位这份美国公开标签，不推定其他市场批准、供应、可售资格、原研/仿制关系或任何个人适用性。", "en": "The current SPIRIVA RESPIMAT label lists Initial U.S. Approval: 2004. This year only locates this U.S. public label; it does not establish approval, supply, sale eligibility, originator/generic relationship or individual suitability in another market." }, "source": { "id": "src_3d041c6141f7a895", "label": "DailyMed（NLM）：SPIRIVA RESPIMAT 噻托溴铵定量吸入喷雾剂当前美国公开标签（Boehringer Ingelheim；SPL v16，2026-08-19 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=7b656b14-fcaa-2741-f6f0-e0be48971c02", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "date": "2026-08-19", "title": { "zh": "DailyMed 发布当前 SPL v16", "en": "DailyMed published current SPL v16" }, "detail": { "zh": "DailyMed 媒体目录将这份 SPIRIVA RESPIMAT 标签标示为 SPL v16，并列示 2026-08-19 发布。本页只用其核对两个专用吸入器＋药筒、每次按压标示量、各自 NDC 和 60 次标签按压；不据此判断实际在售、库存、购买或个人操作。", "en": "The DailyMed media catalogue identifies this SPIRIVA RESPIMAT label as SPL v16 and lists publication on 19 Aug 2026. This page uses it only to check the two inhaler-and-cartridge systems, labelled amount per actuation, their NDCs and 60 labelled actuations; it does not establish actual marketing, stock, purchase or individual operation." }, "source": { "id": "src_3d041c6141f7a895", "label": "DailyMed（NLM）：SPIRIVA RESPIMAT 噻托溴铵定量吸入喷雾剂当前美国公开标签（Boehringer Ingelheim；SPL v16，2026-08-19 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=7b656b14-fcaa-2741-f6f0-e0be48971c02", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "已链接当前公开标签与两个准确包装面板", "en": "Current public label and two exact package panels linked" }, "detail": { "zh": "本页分别展示 1.25 mcg 和 2.5 mcg 每次按压、各一个 RESPIMAT 吸入器＋专用药筒、各 60 次标签按压的纸盒（NDC 0597-0160-61 与 NDC 0597-0100-61）。它们不用于鉴定真伪，也不建立实际在售、库存、购买、个人使用次数、换药、装置互换或可替代性。", "en": "This page separately displays the 1.25 mcg and 2.5 mcg per-actuation cartons, each with one RESPIMAT inhaler plus its dedicated cartridge and 60 labelled actuations (NDC 0597-0160-61 and NDC 0597-0100-61). They do not authenticate a product or establish actual marketing, stock, purchase, individual use count, switching, device interchangeability or substitutability." } }, { "market": { "zh": "中国大陆、欧盟、日本及其他市场", "en": "Mainland China, EU, Japan and other markets" }, "status": { "zh": "待逐项建立现行市场记录", "en": "Current market record not established" }, "detail": { "zh": "不从美国标签、英文品牌、NDC、药筒、帽色或包装图推定当地商品名、批准、包装、供应、可售资格、原研/仿制关系或可替代性；每个市场均须按当地现行监管资料单独核对。", "en": "No local trade name, approval, packaging, supply, sale eligibility, originator/generic relationship or interchangeability is inferred from the U.S. label, English brand, NDC, cartridge, cap colour or package image; every market requires separate review against current local regulatory material." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "同为噻托溴铵，SPIRIVA RESPIMAT 与 SPIRIVA HANDIHALER 能否按微克数、装置名或“都是吸入药”自行换用？", "en": "Both name tiotropium. Can SPIRIVA RESPIMAT and SPIRIVA HANDIHALER be self-switched by microgram number, device name or because both are inhalers?" }, "answer": { "zh": "不能。RESPIMAT 是定量喷雾吸入器与专用药筒，HANDIHALER 是粉雾剂胶囊与专用装置；共同成分、品牌家族或微克数不建立转换公式或替代关系。请把两种实际包装、装置和完整药单交给药师或开方团队核对。", "en": "No. RESPIMAT is a metered spray inhaler with a dedicated cartridge, while HANDIHALER is an inhalation-powder capsule with its dedicated device; a shared ingredient, brand family or microgram number does not establish a conversion or substitution. Take both actual packs, devices and the full medicine list to a pharmacist or prescribing team." } }, { "question": { "zh": "包装写 1.25 mcg、2.5 mcg 或 60 次标签按压，是否表示可以自己计算或改变使用次数？", "en": "Do 1.25 mcg, 2.5 mcg or 60 labelled actuations on the carton mean someone can calculate or change their own use count?" }, "answer": { "zh": "不是。这些是这个准确美国标签产品的按压标示量与包装身份。页面不提供个人次数、时间表、漏用处理、加用、装置步骤或购买建议；请按手上准确标签，并向药师或医生核对。", "en": "No. These are the labelled per-actuation amount and package identity for this exact U.S.-labelled product. This page provides no personal use count, schedule, missed-use action, escalation, device steps or purchase advice; use the exact label in hand and check with a pharmacist or clinician." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "dosage-forms-are-part-of-medicine-identity", "how-to-read-a-drug-label" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/spiriva-respimat/", "en": "https://origindrug.com/en/drugs/spiriva-respimat/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "claritin", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-20", "status": "published_traceable_archive" }, "names": { "brand": "Claritin", "generic": "氯雷他定", "aliases": [ "开瑞坦", "loratadine" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "呼吸系统", "sourceArchiveMarket": "美国 OTC 公开标签档案（当前页面精确对应 10 mg、70 片瓶装纸盒，NDC 11523-6655-2）", "dosageFormClass": "口服片剂（本档案限定为 10 mg 氯雷他定片）", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "未在本页推定（应按目标市场官方记录核验）", "archiveSponsorText": "DailyMed（NLM）公开标签档案" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [ "Claritin-D", "Claritin D", "loratadine pseudoephedrine", "CLARITIN chewable", "CLARITIN oral solution", "氯雷他定咀嚼片", "氯雷他定口服液" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-claritin-tablet-10mg-70ct-ndc-11523-6655-2", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v9，2025-12-05 发布", "en": "DailyMed SPL v9, published 5 Dec 2025" }, "dosageForm": { "zh": "CLARITIN 氯雷他定口服片", "en": "CLARITIN loratadine oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 11523-6655-2", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片 10 mg；70 片瓶装纸盒", "en": "10 mg per tablet; 70-tablet bottle carton" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=70+count+window+box+carton.jpg&setid=ac32d6f9-f553-4d5c-ad36-575af5ea56de&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "氯雷他定", "en": "loratadine" }, "value": 10, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标示量；不是个人片数", "en": "labelled amount per tablet; not an individual tablet count" } } ], "concentration": null, "container": { "typeCode": "bottle_carton", "typeLabel": { "zh": "70 片瓶装纸盒", "en": "70-tablet bottle carton" }, "fill": null, "countPerPackage": 70, "countUnit": { "zh": "片/瓶装纸盒", "en": "tablets per bottle carton" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-20", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 70, "unit": { "zh": "片/瓶装纸盒", "en": "tablets per bottle carton" } }, "physicalClues": { "color": { "zh": "蓝白色 70 片外盒展示面", "en": "blue-and-white 70-tablet carton display panel" }, "shape": { "zh": "口服片", "en": "oral tablet" }, "imprint": null, "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_90cb15976817544b", "label": "DailyMed（NLM）：CLARITIN 氯雷他定 10 mg 当前美国 OTC 公开标签（Bayer HealthCare；SPL v9，2025-12-05 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ac32d6f9-f553-4d5c-ad36-575af5ea56de", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-claritin-tablet-10mg-70ct-ndc-11523-6655-2", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=70+count+window+box+carton.jpg&setid=ac32d6f9-f553-4d5c-ad36-575af5ea56de&type=img", "alt": "CLARITIN 氯雷他定片在美国 DailyMed Bayer 公开标签中的 10 mg、NDC 11523-6655-2、70 片瓶装纸盒展示面", "archiveMarket": "美国", "labelVersion": "DailyMed SPL v9（2025-12-05 发布）", "presentation": "CLARITIN 氯雷他定口服片：每片 10 mg，NDC 11523-6655-2，70 片瓶装纸盒展示面。", "notice": "此图只对应美国 DailyMed 当前标签中 CLARITIN、氯雷他定 10 mg、NDC 11523-6655-2 与 70 片瓶装纸盒。它只帮助核对品牌、通用名、每片标示量、片剂、包装数量与来源；不用于鉴定真伪，也不证明 Claritin-D、咀嚼片、口服液、其他包装、其他市场、当前可得性、原研身份、可替代性或任何个人的片数、联用、开始、停用或换药方案。", "source": { "id": "src_90cb15976817544b", "label": "DailyMed（NLM）：CLARITIN 氯雷他定 10 mg 当前美国 OTC 公开标签（Bayer HealthCare；SPL v9，2025-12-05 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ac32d6f9-f553-4d5c-ad36-575af5ea56de", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "CLARITIN / 开瑞坦说明书放大阅读：10 mg 先是这一片剂的身份", "en": "CLARITIN label reading: 10 mg first identifies this tablet presentation" }, "summary": { "zh": "本模块以美国 DailyMed 公开标签为阅读入口，帮助核对 CLARITIN、氯雷他定、每片 10 mg、口服片剂与目标市场。它不把包装数字转成任何人的片数、疗程、换药或联用方案。", "en": "This module uses the U.S. DailyMed public label to check CLARITIN, loratadine, 10 mg per tablet, oral-tablet form and target market. It does not turn package wording into an individual's tablet count, course, switch or combination plan." }, "checks": [ { "zh": "先把商品名 CLARITIN、通用名氯雷他定（loratadine）、每片 10 mg、口服片剂和目标市场一起核对。10 mg 是本档案片剂的标示强度，不是网页给任何人计算片数的答案。", "en": "Check CLARITIN, loratadine, 10 mg per tablet, oral-tablet form and target market together. 10 mg is the stated strength for this archived tablet, not a web answer to how many tablets anyone should take." }, { "zh": "CLARITIN 还可有咀嚼片或口服溶液等不同剂型；不要因为都含氯雷他定，或都写“抗过敏”，就把片剂、咀嚼片和液体按片数、毫升或经验自行换算、替换或叠加。", "en": "CLARITIN can also appear as chewable tablets or oral solution. A shared loratadine ingredient or “allergy” wording does not make tablets, chewables and liquids self-convertible, substitutable or combinable by tablet count, millilitres or experience." }, { "zh": "该标签提示肝肾疾病时应先询问专业人员。若家中还在使用其他感冒、睡眠、皮肤过敏或草本产品，应携带完整药单和实际包装请药师核对重复成分与相互作用，不要只按商品名判断。", "en": "The label directs readers with liver or kidney disease to ask a professional first. With other cold, sleep, skin-allergy or herbal products at home, take the complete medicine list and actual packs to a pharmacist to review duplicate ingredients and interactions rather than judging from brand names alone." }, { "zh": "包装照片、名称或“非处方”标识都不能鉴定真伪、证明可互换性或替代目标市场的当前标签。出现过敏反应或不确定怎样使用时，应按当地医疗渠道处理，不要依赖网页自行调整。", "en": "A package photo, name or OTC marking cannot authenticate a product, prove interchangeability or replace the current label in the target market. With an allergic reaction or uncertainty about use, use local medical channels rather than self-adjusting from a webpage." } ], "source": { "id": "src_90cb15976817544b", "label": "DailyMed（NLM）：CLARITIN 10 mg 氯雷他定片公开标签（Bayer，2025-12 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ac32d6f9-f553-4d5c-ad36-575af5ea56de", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "氯雷他定怎样被标签归类：先读“抗组胺药”，不要从类别推导个人方案", "en": "How loratadine is classified on the label: read “antihistamine” without deriving a personal plan" }, "summary": { "zh": "美国 DailyMed 标签把氯雷他定标为抗组胺药。这个分类帮助理解标签的用途与警示栏目，但标签类别不是个人适用性、用量、与其他抗过敏药叠加或转换的结论。", "en": "The U.S. DailyMed label classifies loratadine as an antihistamine. This helps readers locate the label's use and warning sections, but a label class is not a conclusion about individual suitability, amount, combination with another allergy medicine or switching." }, "checks": [ { "zh": "“抗组胺药”是标签中的类别线索，不是把所有过敏症状、皮疹、鼻塞或眼痒自动归因于同一原因，更不能替代诊断。", "en": "“Antihistamine” is a label-class clue. It does not automatically attribute every rash, congestion or eye symptom to the same cause, and it cannot replace diagnosis." }, { "zh": "同属抗组胺药不表示氯雷他定可与西替利嗪、复方感冒药或另一种抗过敏产品自行叠加、轮换或替代。核对时应查看完整成分、剂型、市场标签和全部用药。", "en": "A shared antihistamine class does not make loratadine self-combinable, alternatable or substitutable with cetirizine, a combination cold medicine or another allergy product. Review complete ingredients, form, market label and all medicines." }, { "zh": "药物类别与包装上的 10 mg 是不同层面的信息；类别不能把不同剂型或不同规格变成可凭经验换算的产品。任何变更应回到准确产品的现行标签与专业人员。", "en": "Drug class and the 10 mg wording on a pack are different layers of information. Class does not make forms or strengths convertible by experience. Any change must return to the current label for the exact product and a professional." } ], "source": { "id": "src_90cb15976817544b", "label": "DailyMed（NLM）：CLARITIN 10 mg 氯雷他定片公开标签（Bayer，2025-12 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ac32d6f9-f553-4d5c-ad36-575af5ea56de", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "Claritin", "generic": "氯雷他定", "dosageFormClass": "口服片剂（本档案限定为 10 mg 氯雷他定片）" }, "labelSource": { "id": "src_90cb15976817544b", "label": "DailyMed（NLM）：CLARITIN 10 mg 氯雷他定片公开标签（Bayer，2025-12 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ac32d6f9-f553-4d5c-ad36-575af5ea56de", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "productRoutes": [ { "source": { "id": "src_90cb15976817544b", "label": "DailyMed（NLM）：CLARITIN 10 mg 氯雷他定片公开标签（Bayer，2025-12 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ac32d6f9-f553-4d5c-ad36-575af5ea56de", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "DailyMed 的 CLARITIN（loratadine）美国 OTC 公开标签将本档案所列产品标示为每片 10 mg 的口服抗组胺片剂。页面帮助阅读品牌、通用名、每片强度、口服片剂和美国标签范围；不据此推定中国大陆或其他市场的批准、包装、持有人、原研关系、供应或可售资格。", "history": "同一品牌可见片剂、咀嚼片和口服溶液等不同呈现。通用名相同、都写“抗过敏”或包装数字相近，均不足以把不同剂型、不同市场或不同版本当作可互换产品。", "sourceDocuments": [ { "id": "src_90cb15976817544b", "label": "DailyMed（NLM）：CLARITIN 10 mg 氯雷他定片公开标签（Bayer，2025-12 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ac32d6f9-f553-4d5c-ad36-575af5ea56de", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_5ed30b676fbb9773", "label": "FDA Drugs@FDA 官方检索入口", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_lookup_entry", "documentKind": "regulatory_lookup", "market": "US", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } ], "applicationNumber": "DailyMed U.S. OTC label record", "approvalTimeline": [ { "date": "2025-12", "title": { "zh": "DailyMed 公开标签版本", "en": "DailyMed public label version" }, "detail": { "zh": "本页链接 2025-12 的 DailyMed 美国 OTC 公开标签作为可复核阅读入口。它标识该具体公开标签，不推定初始批准年份、NDA 编号、当前供应、持有人或其他市场状态。", "en": "This page links the 2025-12 DailyMed U.S. OTC public label as a traceable reading entry point. It identifies that specific public label and does not assert an original-approval year, NDA number, current availability, holder or another-market status." }, "source": { "id": "src_90cb15976817544b", "label": "DailyMed: CLARITIN loratadine public OTC label", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ac32d6f9-f553-4d5c-ad36-575af5ea56de", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "已链接 OTC 公开标签", "en": "OTC public label linked" }, "detail": { "zh": "仅对应本页所列 DailyMed OTC 文件。", "en": "Only the DailyMed OTC document listed on this page is linked." } }, { "market": { "zh": "中国大陆、欧盟、日本", "en": "Mainland China, EU, Japan" }, "status": { "zh": "待逐项建立市场记录", "en": "Market record not established" }, "detail": { "zh": "不从美国 OTC 标签推定当地批准、持有人、规格、供应或可售资格。", "en": "No local approval, holder, strength, supply or sale-eligibility conclusion is inferred from the U.S. OTC label." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "美国 OTC 标签能代表其他市场或个人用法吗？", "en": "Does a U.S. OTC label represent another market or personal use?" }, "answer": { "zh": "不能。它仅是这一具体美国公开标签的阅读入口；目标市场的现行文件和个人情况必须分别由专业人员核对。", "en": "No. It is only a reading entry point for this specific U.S. public label; the current target-market document and individual circumstances need separate professional review." } }, { "question": { "zh": "为什么不把 OTC 档案写成原始批准或原研结论？", "en": "Why does the OTC archive not state original approval or originator conclusions?" }, "answer": { "zh": "标签记录不足以证明这些结论。它们需要可追溯的产品、剂型、市场、时间和一手监管记录，并经人工审核。", "en": "A label record is insufficient to prove those conclusions. They require traceable product, dosage-form, market, date and primary regulatory records with human review." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "how-to-read-a-drug-label", "regulatory-sources-first" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/claritin/", "en": "https://origindrug.com/en/drugs/claritin/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "zyrtec", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-21", "status": "published_traceable_archive" }, "names": { "brand": "Zyrtec", "generic": "西替利嗪", "aliases": [ "仙特明", "cetirizine", "cetirizine hydrochloride" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "呼吸系统", "sourceArchiveMarket": "美国 OTC 公开标签档案（当前页面精确对应 10 mg、30 片瓶装纸盒，NDC 50580-726-71）", "dosageFormClass": "口服薄膜衣片（本档案限定为 10 mg 西替利嗪盐酸盐片）", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "未在本页推定（应按目标市场官方记录核验）", "archiveSponsorText": "DailyMed（NLM）公开标签档案" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [ "ZYRTEC ALLERGY 10 mg Tablets" ], "excludedProductCues": [ "ZYRTEC-D", "ZYRTEC D", "cetirizine pseudoephedrine", "ZYRTEC Chewable", "ZYRTEC oral solution", "ZYRTEC liquid" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-zyrtec-allergy-tablet-10mg-30ct-ndc-50580-726-71", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v25；页面 2025-10-10 更新，2025-11-17 发布", "en": "DailyMed SPL v25; page updated 10 Oct 2025 and published 17 Nov 2025" }, "dosageForm": { "zh": "ZYRTEC ALLERGY 盐酸西替利嗪薄膜衣口服片", "en": "ZYRTEC ALLERGY cetirizine hydrochloride film-coated oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 50580-726-71", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片西替利嗪盐酸盐 10 mg；30 片瓶装纸盒", "en": "Cetirizine hydrochloride 10 mg per tablet; 30-tablet bottle carton" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=Zyrtec-1.jpg&setid=b165db38-b302-4220-8627-77cb07bb078c&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "盐酸西替利嗪", "en": "cetirizine hydrochloride" }, "value": 10, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、联用或换药规则", "en": "labelled amount per tablet; not an individual's tablet count, combination or switching rule" } } ], "concentration": null, "container": { "typeCode": "bottle_carton", "typeLabel": { "zh": "30 片瓶装纸盒", "en": "30-tablet bottle carton" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "片/瓶装纸盒", "en": "tablets per bottle carton" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-21", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 30, "unit": { "zh": "片/瓶装纸盒", "en": "tablets per bottle carton" } }, "physicalClues": { "color": { "zh": "白色", "en": "white" }, "shape": { "zh": "圆角长方形、双凸薄膜衣片", "en": "rounded rectangular biconvex film-coated tablet" }, "imprint": "ZYRTEC / 10 / MG", "scoreStatus": "scored_status_not_a_split_instruction", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_ca6cef8c5ebbcdf8", "label": "DailyMed（NLM）：ZYRTEC ALLERGY 盐酸西替利嗪 10 mg 薄膜衣片当前美国 OTC 公开标签（Kenvue Brands；SPL v25，2025-11-17 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b165db38-b302-4220-8627-77cb07bb078c", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-zyrtec-allergy-tablet-10mg-30ct-ndc-50580-726-71", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=Zyrtec-1.jpg&setid=b165db38-b302-4220-8627-77cb07bb078c&type=img", "alt": "ZYRTEC ALLERGY 盐酸西替利嗪在美国 DailyMed Kenvue 当前公开标签中的 10 mg、NDC 50580-726-71、30 片瓶装纸盒展示面", "archiveMarket": "美国", "labelVersion": "DailyMed SPL v25（页面 2025-10-10 更新；2025-11-17 发布）", "presentation": "ZYRTEC ALLERGY 盐酸西替利嗪薄膜衣口服片：每片 10 mg，NDC 50580-726-71，30 片瓶装纸盒展示面。", "notice": "此图只对应美国 DailyMed 当前标签中的 ZYRTEC ALLERGY、盐酸西替利嗪 10 mg、NDC 50580-726-71 与 30 片瓶装纸盒。它只帮助核对品牌、通用名、每片标示量、薄膜衣片、包装数量与来源；不用于鉴定真伪，也不证明 ZYRTEC-D、咀嚼片、口服液、其他包装、其他市场、当前可得性、原研身份、可替代性，或任何个人的片数、联用、开始、停用或换药方案。", "source": { "id": "src_ca6cef8c5ebbcdf8", "label": "DailyMed（NLM）：ZYRTEC ALLERGY 盐酸西替利嗪 10 mg 薄膜衣片当前美国 OTC 公开标签（Kenvue Brands；SPL v25，2025-11-17 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b165db38-b302-4220-8627-77cb07bb078c", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "ZYRTEC / 仙特明说明书放大阅读：10 mg 薄膜衣片与其他剂型要分开看", "en": "ZYRTEC label reading: keep the 10 mg film-coated tablet separate from other forms" }, "summary": { "zh": "本模块以美国 DailyMed 公开标签为阅读入口，帮助核对 ZYRTEC、盐酸西替利嗪、每片 10 mg、薄膜衣口服片剂和目标市场。它不提供个人剂量、片数、联用、停用或换药指令。", "en": "This module uses the U.S. DailyMed public label to check ZYRTEC, cetirizine hydrochloride, 10 mg per tablet, film-coated oral-tablet form and target market. It does not provide individual dosing, tablet-count, combination, stopping or switching instructions." }, "checks": [ { "zh": "先把 ZYRTEC、盐酸西替利嗪、每片 10 mg、薄膜衣片和目标市场同时核对。包装上的 10 mg 是该准确片剂的身份字段，不是个人应服几片的网页答案。", "en": "Check ZYRTEC, cetirizine hydrochloride, 10 mg per tablet, film-coated tablet and target market together. The 10 mg on the pack is an identity field for this exact tablet, not a web answer to an individual's tablet count." }, { "zh": "标签提示可能出现嗜睡，并提示酒精、镇静药或安定类药物可能增加嗜睡。若存在这类联用、驾驶/操作机器问题或不适，应带完整药单向药师或医生核对；不要用网页替代个人风险判断。", "en": "The label notes that drowsiness may occur and that alcohol, sedatives or tranquilizers may increase it. With these co-exposures, driving or machinery questions, or symptoms, take the complete medicine list to a pharmacist or clinician rather than using a webpage for individual risk judgement." }, { "zh": "不要因都写“抗过敏”而把本页 ZYRTEC 10 mg 片与 ZYRTEC-D（含伪麻黄碱的复方）、CLARITIN、复方感冒药或其他抗组胺产品自行叠加、隔天轮换或直接替换。共同用途文字不能替代对成分、剂型、市场标签与完整药单的核对。", "en": "Do not self-combine, alternate or directly replace this ZYRTEC 10 mg tablet with ZYRTEC-D (a pseudoephedrine combination), CLARITIN, a combination cold medicine or another antihistamine merely because all mention allergy. Shared use wording does not replace review of ingredients, form, market label and the complete medicine list." }, { "zh": "包装图、刻印或品牌名只可帮助定位来源，不能验证真伪或确定当前批准。肝肾疾病、妊娠哺乳、疑似过敏反应或不确定怎样使用时，应按目标市场现行标签和专业渠道处理。", "en": "Package images, an imprint or a brand name can only help locate a source; they cannot authenticate a product or establish current approval. With liver/kidney disease, pregnancy/breastfeeding, a suspected reaction or uncertainty about use, use the current target-market label and professional channels." } ], "source": { "id": "src_ca6cef8c5ebbcdf8", "label": "DailyMed（NLM）：ZYRTEC ALLERGY 盐酸西替利嗪 10 mg 薄膜衣片当前美国 OTC 公开标签（Kenvue Brands；SPL v25，2025-11-17 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b165db38-b302-4220-8627-77cb07bb078c", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "西替利嗪怎样被标签归类：抗组胺药不等于可自行叠加", "en": "How cetirizine is classified on the label: an antihistamine is not automatically combinable" }, "summary": { "zh": "美国 DailyMed 标签把盐酸西替利嗪标为抗组胺药。该信息用于阅读标签的用途、警示和完整产品身份；它不决定某个人是否适用，或能否与另一种抗过敏、感冒、睡眠或镇静产品同用。", "en": "The U.S. DailyMed label classifies cetirizine hydrochloride as an antihistamine. This helps read the label's use, warning and product-identity information; it does not decide individual suitability or whether another allergy, cold, sleep or sedating product can be used with it." }, "checks": [ { "zh": "药物类别是理解标签的入口，不是症状诊断或自我分诊工具。持续、加重或不明原因的症状应由当地专业渠道判断。", "en": "Drug class is an entry point for understanding a label, not a symptom-diagnosis or self-triage tool. Persistent, worsening or unexplained symptoms need local professional assessment." }, { "zh": "西替利嗪与氯雷他定都可被归入抗组胺药，但共同类别不证明可以同时服用、轮换、把一盒换成另一盒或按毫克数换算。", "en": "Cetirizine and loratadine can both be classed as antihistamines, but a shared class does not prove they can be taken together, alternated, substituted or converted by milligrams." }, { "zh": "标签中的嗜睡与联用警示说明为何完整药单重要；它不是网页把每个人划为“安全”或“不安全”的规则。任何变更应由现行标签和专业人员结合实际产品复核。", "en": "The label's drowsiness and co-use warnings show why a complete medicine list matters; they are not a web rule that sorts every person into “safe” or “unsafe.” Any change needs review of the actual product against the current label with a professional." } ], "source": { "id": "src_ca6cef8c5ebbcdf8", "label": "DailyMed（NLM）：ZYRTEC ALLERGY 盐酸西替利嗪 10 mg 薄膜衣片当前美国 OTC 公开标签（Kenvue Brands；SPL v25，2025-11-17 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b165db38-b302-4220-8627-77cb07bb078c", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "Zyrtec", "generic": "西替利嗪", "dosageFormClass": "口服薄膜衣片（本档案限定为 10 mg 西替利嗪盐酸盐片）" }, "labelSource": { "id": "src_ca6cef8c5ebbcdf8", "label": "DailyMed（NLM）：ZYRTEC ALLERGY 盐酸西替利嗪 10 mg 薄膜衣片当前美国 OTC 公开标签（Kenvue Brands；SPL v25，2025-11-17 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b165db38-b302-4220-8627-77cb07bb078c", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "productRoutes": [ { "source": { "id": "src_ca6cef8c5ebbcdf8", "label": "DailyMed（NLM）：ZYRTEC ALLERGY 盐酸西替利嗪 10 mg 薄膜衣片当前美国 OTC 公开标签（Kenvue Brands；SPL v25，2025-11-17 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b165db38-b302-4220-8627-77cb07bb078c", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [ { "id": "fda-2025-cetirizine-zyrtec-pruritus-after-stopping-safety-communication", "issuedAt": "2025-05-16", "status": "fda_drug_safety_communication", "title": { "zh": "FDA 药物安全通讯：停止长期使用口服西替利嗪／Zyrtec 后罕见但可能严重的瘙痒", "en": "FDA Drug Safety Communication: rare but severe itching after stopping long-term oral cetirizine/Zyrtec" }, "summary": { "zh": "FDA 于 2025-05-16 发布药物安全通讯，说明口服西替利嗪（Zyrtec）或左西替利嗪在长期规律使用后停用，可能出现罕见但可能严重的瘙痒；通讯涉及美国处方与非处方制剂的标签更新。该记录是美国、特定日期和成分／产品线索的监管沟通，不能判断手中任一 Zyrtec 包装、其他抗过敏药、其他市场或任何个人是否会发生此情况，也不支持依据网页自行停药、重新使用、减量或换药。若实际停用后出现严重瘙痒，请尽快联系当地药师、开方团队或医疗服务，并携带实际包装与完整用药清单核对。", "en": "On 2025-05-16, FDA issued a Drug Safety Communication saying that rare but severe itching can occur after stopping long-term, regular use of oral cetirizine (Zyrtec) or levocetirizine; the communication covers U.S. prescription and over-the-counter label updates. This is a dated U.S. regulator communication tied to named ingredients/products. It cannot determine whether any Zyrtec pack, another allergy medicine, another market or any individual will have this outcome, and it does not support self-stopping, restarting, tapering or switching from this page. Severe itching after stopping needs prompt contact with a local pharmacist, prescribing team or medical service, with the actual pack and complete medicine list." }, "source": { "id": "src_72aeda1f7f249ce3", "label": "FDA：2025-05-16 停止长期使用口服西替利嗪／Zyrtec 后瘙痒的药物安全通讯", "url": "https://www.fda.gov/drugs/drug-safety-communications/fda-requires-warning-about-rare-severe-itching-after-stopping-long-term-use-oral-allergy-medicines", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-03", "reviewedAt": "2026-09-03" } } ], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "DailyMed 的 ZYRTEC ALLERGY（cetirizine hydrochloride）美国 OTC 公开标签将本档案所列产品标示为每片 10 mg 的口服薄膜衣片。页面只帮助核对产品身份、标签警示和来源，不推定其他市场的批准、包装、原研关系、供应或可售资格。", "history": "西替利嗪产品可有不同强度、片剂和液体等呈现。名字、相同成分或“24 小时”等包装语言不能证明个人可以自行换算、叠加、替代或改变使用方式。", "sourceDocuments": [ { "id": "src_ca6cef8c5ebbcdf8", "label": "DailyMed（NLM）：ZYRTEC ALLERGY 盐酸西替利嗪 10 mg 薄膜衣片当前美国 OTC 公开标签（Kenvue Brands；SPL v25，2025-11-17 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b165db38-b302-4220-8627-77cb07bb078c", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_5ed30b676fbb9773", "label": "FDA Drugs@FDA 官方检索入口", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_lookup_entry", "documentKind": "regulatory_lookup", "market": "US", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } ], "applicationNumber": "DailyMed U.S. OTC label record", "approvalTimeline": [ { "date": "2025-11", "title": { "zh": "DailyMed 公开标签版本", "en": "DailyMed public label version" }, "detail": { "zh": "本页链接 2025-11 的 DailyMed 美国 OTC 公开标签作为可复核阅读入口。它标识该具体公开标签，不推定初始批准年份、NDA 编号、当前供应、持有人或其他市场状态。", "en": "This page links the 2025-11 DailyMed U.S. OTC public label as a traceable reading entry point. It identifies that specific public label and does not assert an original-approval year, NDA number, current availability, holder or another-market status." }, "source": { "id": "src_ca6cef8c5ebbcdf8", "label": "DailyMed: ZYRTEC ALLERGY cetirizine 10 mg current public OTC label", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b165db38-b302-4220-8627-77cb07bb078c", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "已链接 OTC 公开标签", "en": "OTC public label linked" }, "detail": { "zh": "仅对应本页所列 DailyMed OTC 文件。", "en": "Only the DailyMed OTC document listed on this page is linked." } }, { "market": { "zh": "中国大陆、欧盟、日本", "en": "Mainland China, EU, Japan" }, "status": { "zh": "待逐项建立市场记录", "en": "Market record not established" }, "detail": { "zh": "不从美国 OTC 标签推定当地批准、持有人、规格、供应或可售资格。", "en": "No local approval, holder, strength, supply or sale-eligibility conclusion is inferred from the U.S. OTC label." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "美国 OTC 标签能代表其他市场或个人用法吗？", "en": "Does a U.S. OTC label represent another market or personal use?" }, "answer": { "zh": "不能。它仅是这一具体美国公开标签的阅读入口；目标市场的现行文件和个人情况必须分别由专业人员核对。", "en": "No. It is only a reading entry point for this specific U.S. public label; the current target-market document and individual circumstances need separate professional review." } }, { "question": { "zh": "为什么不把 OTC 档案写成原始批准或原研结论？", "en": "Why does the OTC archive not state original approval or originator conclusions?" }, "answer": { "zh": "标签记录不足以证明这些结论。它们需要可追溯的产品、剂型、市场、时间和一手监管记录，并经人工审核。", "en": "A label record is insufficient to prove those conclusions. They require traceable product, dosage-form, market, date and primary regulatory records with human review." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "how-to-read-a-drug-label", "regulatory-sources-first" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/zyrtec/", "en": "https://origindrug.com/en/drugs/zyrtec/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "benadryl", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-25", "status": "published_traceable_archive" }, "names": { "brand": "BENADRYL", "generic": "盐酸苯海拉明", "aliases": [ "BENADRYL", "diphenhydramine", "diphenhydramine hydrochloride", "苯海拉明", "盐酸苯海拉明", "50580-226-12", "50580-226-50" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "呼吸系统", "sourceArchiveMarket": "美国：DailyMed 当前 BENADRYL 盐酸苯海拉明 25 mg 薄膜衣片公开标签（SPL v31，2026-02-06 更新）；本页仅展示标签明确列出的两组准确包装身份，不建立中国大陆、欧盟、日本或其他市场的批准、供应、可售或原研/仿制结论。", "dosageFormClass": "盐酸苯海拉明 25 mg 薄膜衣口服片：准确包装、标签警示和产品族边界必须同时核对", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "DailyMed SPL v31（2026-02-06 更新的美国 OTC 公开标签；不据此推定其他市场状态）", "archiveSponsorText": "Kenvue Brands LLC（所引美国现行公开标签所列）" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [ "BENADRYL Allergy Plus Congestion", "BENADRYL Allergy & Sinus", "BENADRYL Extra Strength Itch Stopping Gel", "BENADRYL topical", "BENADRYL liquid", "BENADRYL children's", "other diphenhydramine package", "其他苯海拉明包装" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-benadryl-diphenhydramine-hcl-tablet-25mg-12blister-ndc-50580-226-12", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v31（2026-02-06 更新）", "en": "DailyMed SPL v31 (updated 6 Feb 2026)" }, "dosageForm": { "zh": "薄膜衣口服片", "en": "film-coated oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 50580-226-12", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "BENADRYL 盐酸苯海拉明 25 mg、12 片泡罩装", "en": "BENADRYL diphenhydramine hydrochloride 25 mg, 12-tablet blister pack" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=benadryl-01.jpg&archiveid=946509", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "盐酸苯海拉明（每片）", "en": "Diphenhydramine hydrochloride (per tablet)" }, "value": 25, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、间隔或一日总量", "en": "Labelled amount per tablet; not an individual's tablet count, timing interval or daily total" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": null, "package": { "count": 12, "unit": { "zh": "片/泡罩装", "en": "tablets per blister pack" } }, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_4d998d797254abdd", "label": "DailyMed (NLM): BENADRYL 25 mg, NDC 50580-226-12, 12-tablet blister-pack panel (Kenvue; SPL v31)", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=702f9786-7ce9-43e4-921d-e1db09612127&version=31", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-25", "reviewedAt": "2026-08-25" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-benadryl-diphenhydramine-hcl-tablet-25mg-100bottle-ndc-50580-226-50", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v31（2026-02-06 更新）", "en": "DailyMed SPL v31 (updated 6 Feb 2026)" }, "dosageForm": { "zh": "薄膜衣口服片", "en": "film-coated oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 50580-226-50", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "BENADRYL 盐酸苯海拉明 25 mg、100 片瓶装", "en": "BENADRYL diphenhydramine hydrochloride 25 mg, 100-tablet bottle" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "盐酸苯海拉明（每片）", "en": "Diphenhydramine hydrochloride (per tablet)" }, "value": 25, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、间隔或一日总量", "en": "Labelled amount per tablet; not an individual's tablet count, timing interval or daily total" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": null, "package": { "count": 100, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_4d998d797254abdd", "label": "DailyMed (NLM): BENADRYL 25 mg, NDC 50580-226-50, 100-tablet bottle listing (Kenvue; SPL v31)", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=702f9786-7ce9-43e4-921d-e1db09612127&version=31", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-25", "reviewedAt": "2026-08-25" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-benadryl-diphenhydramine-hcl-tablet-25mg-12blister-ndc-50580-226-12", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=benadryl-01.jpg&archiveid=946509", "alt": "BENADRYL 盐酸苯海拉明 25 mg、NDC 50580-226-12、12 片泡罩装在美国 DailyMed 现行公开标签中的包装图", "archiveMarket": "美国", "labelVersion": "DailyMed SPL v31（2026-02-06 更新）", "presentation": "BENADRYL 盐酸苯海拉明：每片 25 mg，NDC 50580-226-12，12 片泡罩装（美国现行公开标签）。", "notice": "此图只对应所引美国 DailyMed 标签中的 BENADRYL、盐酸苯海拉明 25 mg、NDC 50580-226-12 与 12 片泡罩装。它帮助核对品牌、成分、每片标示量、包装和来源；不用于鉴定真伪，也不代表复方、夜用/感冒、外用、儿童、液体、其他苯海拉明包装、其他市场、原研身份、可替代性或任何个人的服用、联用、停用、换药或分片方案。", "source": { "id": "src_4d998d797254abdd", "label": "DailyMed (NLM): current U.S. BENADRYL diphenhydramine hydrochloride public label (Kenvue; SPL v31, updated 6 Feb 2026)", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=702f9786-7ce9-43e4-921d-e1db09612127&version=31", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-25", "reviewedAt": "2026-08-25" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "BENADRYL／苯海拉明说明书放大阅读：先核对是否已经有其他苯海拉明", "en": "BENADRYL label reading: first check for another diphenhydramine product" }, "summary": { "zh": "本模块只阅读所引美国 OTC 标签中的 BENADRYL 薄膜衣片、每片标示量、NDC、包装和警示。它不提供个人片数、服用间隔、停用、联用、换药、分片或购买方案。", "en": "This module reads only the cited U.S. OTC BENADRYL film-coated tablet, labelled amount per tablet, NDC, package and warnings. It provides no individual tablet count, timing, stopping, co-use, switching, splitting or purchase plan." }, "checks": [ { "zh": "标签明确写明不要与任何其他含苯海拉明产品合用，包括皮肤外用产品。先把所有“夜用”“感冒”“止痒”“过敏”、处方、非处方和外用产品的成分表交给药师或医生核对；同一成分可能藏在不同名称和不同剂型中。", "en": "The label explicitly says not to use with any other product containing diphenhydramine, including a product used on the skin. First have a pharmacist or clinician review the ingredient panels of every “night-time,” cold, itch, allergy, prescription, OTC and topical product; the same ingredient can appear under different names and forms." }, { "zh": "每片 25 mg 只识别所引薄膜衣片的标签成分字段；12 片泡罩装或 100 片瓶装只是包装身份。它们不构成个人片数、间隔、补用、加倍、联用或换药规则。", "en": "The 25 mg field identifies only the labelled ingredient in the cited film-coated tablet; the 12-tablet blister and 100-tablet bottle are package identities. They do not establish individual tablet count, timing, catch-up, doubling, co-use or switching rules." }, { "zh": "标签提示显著嗜睡，酒精、镇静药和安定类药物可能增加嗜睡，并提示驾驶或操作机械时谨慎。若实际药单中已有这些项目、或出现跌倒、明显困倦、意识改变、呼吸困难或其他急性担忧，应优先联系当地医疗支持；不要从网页自行增减或叠加产品。", "en": "The label warns that marked drowsiness may occur, that alcohol, sedatives and tranquilizers may increase drowsiness, and that driving or operating machinery needs caution. If the actual medicine list already includes these items, or there is a fall, marked sleepiness, change in consciousness, breathing difficulty or another acute concern, prioritise local medical support; do not self-adjust or combine products from a webpage." }, { "zh": "标签把青光眼、慢性呼吸问题及因前列腺增大导致排尿困难列为需要先咨询的情境。网页不能据此判断任何人是否适合用药；请将准确药盒、症状和完整药单交给药师或医生。", "en": "The label lists glaucoma, chronic breathing problems and trouble urinating due to an enlarged prostate as situations requiring prior consultation. A webpage cannot determine whether any person can use the product; bring the exact package, symptoms and complete medicine list to a pharmacist or clinician." } ], "source": { "id": "src_4d998d797254abdd", "label": "DailyMed (NLM): current U.S. BENADRYL public label (warnings and Drug Facts; Kenvue; SPL v31)", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=702f9786-7ce9-43e4-921d-e1db09612127&version=31", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-25", "reviewedAt": "2026-08-25" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "苯海拉明怎样起作用：抗组胺类别术语不能用来推导“夜用”方案", "en": "How diphenhydramine works: an antihistamine class term cannot create a night-time plan" }, "summary": { "zh": "标签将盐酸苯海拉明列为抗组胺药。本页用这一类别帮助读者检查成分重复和嗜睡警示；不诊断症状来源，也不判断是否应使用、怎样与其他过敏、感冒、镇静或外用产品衔接。", "en": "The label lists diphenhydramine hydrochloride as an antihistamine. This page uses that class to help check ingredient duplication and drowsiness warnings; it does not diagnose symptoms or decide whether to use it, or how it relates to another allergy, cold, sedating or topical product." }, "checks": [ { "zh": "“抗组胺”“夜用”或“止痒”不是自行把多种产品叠加的理由。不同产品可能包含苯海拉明、其他抗组胺成分或多种成分；必须逐项按实际包装和完整药单核对。", "en": "“Antihistamine,” “night-time,” or “itch relief” is not a reason to self-combine products. Different products may contain diphenhydramine, another antihistamine or multiple ingredients; check each actual package and the complete medicine list." }, { "zh": "机制页不能解释一个人的失眠、跌倒、困倦、头晕、视物异常、排尿困难、呼吸问题或其他症状，也不能替代对酒精、镇静药、抗焦虑药、处方药和外用产品的核对。", "en": "A mechanism page cannot explain an individual's insomnia, fall, sleepiness, dizziness, visual symptom, urination difficulty, breathing problem or another symptom, nor replace review of alcohol, sedatives, anxiety medicines, prescriptions and topical products." }, { "zh": "出现意识改变、呼吸困难、昏厥、严重过敏、跌倒受伤或其他急性担忧时，应优先使用当地紧急医疗渠道；不要同时改变多种药来试探原因。", "en": "With altered consciousness, breathing difficulty, fainting, severe allergy, injury from a fall or another acute concern, use local urgent medical pathways first; do not change several medicines at once to test the cause." } ], "source": { "id": "src_4d998d797254abdd", "label": "DailyMed (NLM): current U.S. BENADRYL public label (Drug Facts; Kenvue; SPL v31)", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=702f9786-7ce9-43e4-921d-e1db09612127&version=31", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-25", "reviewedAt": "2026-08-25" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "BENADRYL", "generic": "盐酸苯海拉明", "dosageFormClass": "盐酸苯海拉明 25 mg 薄膜衣口服片：准确包装、标签警示和产品族边界必须同时核对" }, "labelSource": { "id": "src_4d998d797254abdd", "label": "DailyMed (NLM): current U.S. BENADRYL diphenhydramine hydrochloride public label (Kenvue; SPL v31, updated 6 Feb 2026)", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=702f9786-7ce9-43e4-921d-e1db09612127&version=31", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-25", "reviewedAt": "2026-08-25" }, "productRoutes": [ { "source": { "id": "src_4d998d797254abdd", "label": "DailyMed (NLM): current U.S. BENADRYL diphenhydramine hydrochloride public label (Kenvue; SPL v31, updated 6 Feb 2026)", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=702f9786-7ce9-43e4-921d-e1db09612127&version=31", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-25", "reviewedAt": "2026-08-25" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-25", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-25", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "美国 DailyMed 当前 BENADRYL 标签列示每片盐酸苯海拉明 25 mg，并特别提示不要与任何其他含苯海拉明产品（包括皮肤外用产品）合用。页面先帮助核对准确片剂、NDC、包装和嗜睡相关警示；“夜用”“感冒”“抗过敏”或相同成分不能让不同 BENADRYL 家族、复方、液体或外用产品自行叠加、轮换或替换。", "history": "所引标签为 Kenvue Brands LLC 的美国 OTC 公开标签，SPL v31 于 2026-02-06 更新。12 片泡罩装与 100 片瓶装是两个独立包装身份；每片 25 mg 是标签成分字段，不是个人片数、间隔或一日总量。其他含苯海拉明的夜用、感冒、皮肤外用、儿童或液体产品需要另按准确标签核对。", "sourceDocuments": [ { "id": "src_4d998d797254abdd", "label": "DailyMed (NLM): current U.S. BENADRYL diphenhydramine hydrochloride public label (Kenvue; SPL v31, updated 6 Feb 2026)", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=702f9786-7ce9-43e4-921d-e1db09612127&version=31", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-25", "reviewedAt": "2026-08-25" }, { "id": "src_5ed30b676fbb9773", "label": "FDA Drugs@FDA official search", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_lookup_entry", "documentKind": "regulatory_lookup", "market": "US", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } ], "applicationNumber": "DailyMed U.S. OTC label record", "approvalTimeline": [ { "date": "DailyMed SPL v31, updated 2026-02-06", "title": { "zh": "DailyMed 公开标签版本", "en": "DailyMed public label version" }, "detail": { "zh": "本页链接 DailyMed SPL v31, updated 2026-02-06 的 DailyMed 美国 OTC 公开标签作为可复核阅读入口。它标识该具体公开标签，不推定初始批准年份、NDA 编号、当前供应、持有人或其他市场状态。", "en": "This page links the DailyMed SPL v31, updated 2026-02-06 DailyMed U.S. OTC public label as a traceable reading entry point. It identifies that specific public label and does not assert an original-approval year, NDA number, current availability, holder or another-market status." }, "source": { "id": "src_4d998d797254abdd", "label": "DailyMed: BENADRYL diphenhydramine hydrochloride current U.S. OTC label", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=702f9786-7ce9-43e4-921d-e1db09612127&version=31", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-25", "reviewedAt": "2026-08-25" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "已链接 OTC 公开标签", "en": "OTC public label linked" }, "detail": { "zh": "仅对应本页所列 DailyMed OTC 文件。", "en": "Only the DailyMed OTC document listed on this page is linked." } }, { "market": { "zh": "中国大陆、欧盟、日本", "en": "Mainland China, EU, Japan" }, "status": { "zh": "待逐项建立市场记录", "en": "Market record not established" }, "detail": { "zh": "不从美国 OTC 标签推定当地批准、持有人、规格、供应或可售资格。", "en": "No local approval, holder, strength, supply or sale-eligibility conclusion is inferred from the U.S. OTC label." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "美国 OTC 标签能代表其他市场或个人用法吗？", "en": "Does a U.S. OTC label represent another market or personal use?" }, "answer": { "zh": "不能。它仅是这一具体美国公开标签的阅读入口；目标市场的现行文件和个人情况必须分别由专业人员核对。", "en": "No. It is only a reading entry point for this specific U.S. public label; the current target-market document and individual circumstances need separate professional review." } }, { "question": { "zh": "为什么不把 OTC 档案写成原始批准或原研结论？", "en": "Why does the OTC archive not state original approval or originator conclusions?" }, "answer": { "zh": "标签记录不足以证明这些结论。它们需要可追溯的产品、剂型、市场、时间和一手监管记录，并经人工审核。", "en": "A label record is insufficient to prove those conclusions. They require traceable product, dosage-form, market, date and primary regulatory records with human review." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "how-to-read-a-drug-label", "regulatory-sources-first" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/benadryl/", "en": "https://origindrug.com/en/drugs/benadryl/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "flonase-allergy-relief", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-17", "status": "published_traceable_archive" }, "names": { "brand": "Flonase Allergy Relief", "generic": "丙酸氟替卡松", "aliases": [ "辅舒良", "fluticasone propionate", "fluticasone propionate nasal spray" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "呼吸系统", "sourceArchiveMarket": "美国 OTC 公开标签档案", "dosageFormClass": "定量鼻喷雾剂（本档案限定为每喷 50 mcg 丙酸氟替卡松）", "dosageFormClassCode": "other", "route": "鼻腔给药", "routeCode": "other", "historicalApprovalEntry": "未在本页推定（应按目标市场官方记录核验）", "archiveSponsorText": "DailyMed（NLM）公开标签档案" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-flonase-allergy-relief-fluticasone-propionate-50mcg-spray-144-metered-sprays", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国 OTC 公开标签（2024-12-19 更新）", "en": "Current U.S. DailyMed public OTC label (updated 19 Dec 2024)" }, "dosageForm": { "zh": "FLONASE Allergy Relief 丙酸氟替卡松定量鼻喷雾剂", "en": "FLONASE Allergy Relief fluticasone propionate metered nasal spray" }, "route": { "zh": "鼻腔给药（标签产品身份字段）", "en": "nasal (label product-identity field)" }, "routeCodes": [ "nasal" ], "productCode": "NDC 0135-0576", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_metered_nasal_spray", "primaryDisplay": { "zh": "每次定量喷射含丙酸氟替卡松 50 mcg；144 次定量喷射；净含量 18.2 mL", "en": "Fluticasone propionate 50 mcg per metered spray; 144 metered sprays; 18.2 mL" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=Flonase+Allergy+144+sprays.jpg&setid=b6134ba0-b70a-4eac-9a82-cef64b242c1d&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "丙酸氟替卡松（每次定量喷射）", "en": "fluticasone propionate (per metered spray)" }, "value": 50, "unit": "mcg", "basisCode": "per_metered_nasal_spray", "basisLabel": { "zh": "每喷标签标示量；不是个人每次或每日喷数", "en": "labelled amount per spray; not an individual's spray count or daily plan" } } ], "concentration": null, "container": { "typeCode": "metered_nasal_spray_bottle", "typeLabel": { "zh": "定量鼻喷雾瓶", "en": "metered nasal spray bottle" }, "fill": { "value": 18.2, "unit": "mL" }, "countPerPackage": null, "countUnit": null }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-28", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 144, "unit": { "zh": "次定量喷射/瓶", "en": "metered sprays per bottle" } }, "physicalClues": { "color": { "zh": "DailyMed 144 喷包装展示面", "en": "DailyMed 144-spray package display" }, "shape": { "zh": "带定量喷雾泵的鼻喷雾瓶及纸盒", "en": "nasal spray bottle with metered pump and carton" }, "imprint": null, "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_3341ee053e42bbb9", "label": "DailyMed（NLM）：FLONASE Allergy Relief 丙酸氟替卡松鼻喷雾剂当前美国 OTC 公开标签（2024-12-19 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b6134ba0-b70a-4eac-9a82-cef64b242c1d", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": null, "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=Flonase+Allergy+144+sprays.jpg&setid=b6134ba0-b70a-4eac-9a82-cef64b242c1d&type=img", "alt": "FLONASE Allergy Relief 丙酸氟替卡松鼻喷雾剂在美国 DailyMed Haleon 公开标签中的 144 喷装包装图", "archiveMarket": "美国", "labelVersion": "DailyMed 公开标签（Haleon US Holdings，2024-12 更新）", "presentation": "FLONASE Allergy Relief 丙酸氟替卡松鼻喷雾剂、每喷 50 mcg、144 喷装包装图（DailyMed Haleon US Holdings 公开标签所列）。", "notice": "此为美国 DailyMed Haleon US Holdings 公开标签中对应 FLONASE Allergy Relief、每喷 50 mcg、144 喷装的包装图，只帮助核对品牌、通用名、鼻喷雾剂、标示量、喷数和来源；不用于鉴定真伪，也不证明其他喷数、其他装置、其他市场标签、当前可得性、原研身份、目标市场批准或可售资格。", "source": { "id": "src_3341ee053e42bbb9", "label": "DailyMed（NLM）：FLONASE Allergy Relief 公开标签（Haleon US Holdings，2024-12 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b6134ba0-b70a-4eac-9a82-cef64b242c1d", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "FLONASE 说明书放大阅读：每喷 50 mcg 与“仅供鼻腔使用”要一起核对", "en": "FLONASE label reading: read 50 mcg per spray together with “for nasal use only”" }, "summary": { "zh": "本模块以美国 DailyMed 公开标签为阅读入口，帮助核对 FLONASE ALLERGY RELIEF、丙酸氟替卡松、每喷 50 mcg、定量鼻喷雾剂及鼻腔给药途径。它不提供个人喷次、疗程、换产品或与其他激素产品联用的方案。", "en": "This module uses the U.S. DailyMed public label to check FLONASE ALLERGY RELIEF, fluticasone propionate, 50 mcg per spray, metered nasal-spray form and nasal route. It does not provide an individual spray count, course, product switch or plan for combining with another steroid product." }, "checks": [ { "zh": "先将 FLONASE ALLERGY RELIEF、丙酸氟替卡松、每喷 50 mcg、定量鼻喷雾剂和鼻腔给药途径一起核对。50 mcg/喷描述这一个喷雾产品的标示单位，不是网页给任何人的喷次指令。", "en": "Check FLONASE ALLERGY RELIEF, fluticasone propionate, 50 mcg per spray, metered nasal-spray form and nasal route together. 50 mcg/spray describes the labelled unit of this spray, not a web instruction for anyone's spray count." }, { "zh": "标签明确“仅供鼻腔使用”，并提示不要喷入眼睛或口腔。它不能被当作口服、眼用、皮肤用、肺部吸入或另一种鼻喷雾产品的替代品；共同名称片段或“激素”描述不足以证明可换用。", "en": "The label states “for nasal use only” and warns not to spray into the eyes or mouth. It is not a substitute for oral, eye, skin, lung-inhaled or another nasal-spray product; a shared name fragment or “steroid” wording does not establish exchangeability." }, { "zh": "标签提示正在使用 HIV 治疗药物或其他用于哮喘、过敏或皮疹的激素药时要向医生或药师询问。请带上全部处方药、非处方药、吸入器、喷雾和外用产品核对，而不是只看其中一个药盒。", "en": "The label directs readers using HIV medicines or another steroid medicine for asthma, allergies or skin rash to ask a clinician or pharmacist. Bring all prescription, OTC, inhaler, spray and topical products for review rather than looking at one package alone." }, { "zh": "鼻部受伤/手术未愈合、眼部问题、异常不适或疑似过敏反应都不适合从网页自行决定继续、暂停或换用。包装图片和名称也不能验证真伪或当前批准状态。", "en": "A not-yet-healed nasal injury/surgery, eye problems, unusual symptoms or a suspected reaction are not situations for self-deciding continuation, pause or switching from a webpage. Package images and names also cannot authenticate a product or establish current approval." } ], "source": { "id": "src_3341ee053e42bbb9", "label": "DailyMed（NLM）：FLONASE ALLERGY RELIEF 丙酸氟替卡松定量鼻喷雾剂公开标签（Haleon，2024-12 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b6134ba0-b70a-4eac-9a82-cef64b242c1d", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "丙酸氟替卡松怎样被标签归类：糖皮质激素说明产品类别，不代替使用判断", "en": "How fluticasone propionate is classified on the label: “glucocorticoid” describes a class, not a use decision" }, "summary": { "zh": "美国 DailyMed 标签把本产品中的丙酸氟替卡松标为糖皮质激素，并把产品定位为过敏症状缓解药。这个类别说明必须与准确的鼻喷雾剂型、每喷标示和目标市场一起阅读；它不是个人适用性、喷次或与其他激素产品联用的结论。", "en": "The U.S. DailyMed label identifies fluticasone propionate in this product as a glucocorticoid and presents it as an allergy-symptom reliever. This class must be read with the exact nasal-spray form, per-spray wording and target market; it is not a conclusion about individual suitability, spray count or combination with another steroid product." }, "checks": [ { "zh": "“糖皮质激素”是药物类别，不等于所有写有“激素”的药可自行互换、合用或按强度数字换算。鼻喷雾、吸入、皮肤外用、口服或注射产品的途径和标签边界不同。", "en": "“Glucocorticoid” is a drug class; it does not make every product labelled a “steroid” self-interchangeable, combinable or convertible by strength numbers. Nasal sprays, inhaled, topical, oral and injected products have different routes and label boundaries." }, { "zh": "类别和症状文字不能自行判断鼻塞、眼痒、咳嗽或呼吸困难的原因，也不能代替目标市场的现行标签与诊断。", "en": "Class and symptom wording cannot self-diagnose the cause of congestion, itchy eyes, cough or breathing difficulty, and cannot replace the current target-market label and diagnosis." }, { "zh": "如果家中同时有多种鼻喷雾、吸入器、皮肤药或复方感冒药，完整药单比“都叫过敏药”更重要。让药师或医生核对实际产品，而不是根据本页自行调整。", "en": "If several nasal sprays, inhalers, skin products or combination cold medicines are at home, the complete medicine list matters more than calling them all “allergy medicines.” Have a pharmacist or clinician check the actual products rather than self-adjusting from this page." } ], "source": { "id": "src_3341ee053e42bbb9", "label": "DailyMed（NLM）：FLONASE ALLERGY RELIEF 丙酸氟替卡松定量鼻喷雾剂公开标签（Haleon，2024-12 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b6134ba0-b70a-4eac-9a82-cef64b242c1d", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "Flonase Allergy Relief", "generic": "丙酸氟替卡松", "dosageFormClass": "定量鼻喷雾剂（本档案限定为每喷 50 mcg 丙酸氟替卡松）" }, "labelSource": { "id": "src_3341ee053e42bbb9", "label": "DailyMed（NLM）：FLONASE ALLERGY RELIEF 丙酸氟替卡松定量鼻喷雾剂公开标签（Haleon，2024-12 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b6134ba0-b70a-4eac-9a82-cef64b242c1d", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "productRoutes": [ { "source": { "id": "src_3341ee053e42bbb9", "label": "DailyMed（NLM）：FLONASE ALLERGY RELIEF 丙酸氟替卡松定量鼻喷雾剂公开标签（Haleon，2024-12 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b6134ba0-b70a-4eac-9a82-cef64b242c1d", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "DailyMed 的 FLONASE ALLERGY RELIEF（fluticasone propionate）美国 OTC 公开标签将本档案所列产品标示为每喷 50 mcg 的定量鼻喷雾剂，并注明仅供鼻腔使用。页面用于阅读名称、成分、每喷标示、鼻腔给药途径和标签边界；不推定其他市场的批准、包装、原研关系、供应或可售资格。", "history": "“鼻喷雾”“每喷”和“每 mL/每片”等不是同一单位，也不是可在网页上互相换算的产品。不同氟替卡松化合物、不同喷雾器和其他吸入/外用产品必须逐项核对。", "sourceDocuments": [ { "id": "src_3341ee053e42bbb9", "label": "DailyMed（NLM）：FLONASE ALLERGY RELIEF 丙酸氟替卡松定量鼻喷雾剂公开标签（Haleon，2024-12 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b6134ba0-b70a-4eac-9a82-cef64b242c1d", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_5ed30b676fbb9773", "label": "FDA Drugs@FDA 官方检索入口", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_lookup_entry", "documentKind": "regulatory_lookup", "market": "US", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } ], "applicationNumber": "DailyMed U.S. OTC label record", "approvalTimeline": [ { "date": "2024-12", "title": { "zh": "DailyMed 公开标签版本", "en": "DailyMed public label version" }, "detail": { "zh": "本页链接 2024-12 的 DailyMed 美国 OTC 公开标签作为可复核阅读入口。它标识该具体公开标签，不推定初始批准年份、NDA 编号、当前供应、持有人或其他市场状态。", "en": "This page links the 2024-12 DailyMed U.S. OTC public label as a traceable reading entry point. It identifies that specific public label and does not assert an original-approval year, NDA number, current availability, holder or another-market status." }, "source": { "id": "src_3341ee053e42bbb9", "label": "DailyMed: FLONASE ALLERGY RELIEF public OTC label", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b6134ba0-b70a-4eac-9a82-cef64b242c1d", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "已链接 OTC 公开标签", "en": "OTC public label linked" }, "detail": { "zh": "仅对应本页所列 DailyMed OTC 文件。", "en": "Only the DailyMed OTC document listed on this page is linked." } }, { "market": { "zh": "中国大陆、欧盟、日本", "en": "Mainland China, EU, Japan" }, "status": { "zh": "待逐项建立市场记录", "en": "Market record not established" }, "detail": { "zh": "不从美国 OTC 标签推定当地批准、持有人、规格、供应或可售资格。", "en": "No local approval, holder, strength, supply or sale-eligibility conclusion is inferred from the U.S. OTC label." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "美国 OTC 标签能代表其他市场或个人用法吗？", "en": "Does a U.S. OTC label represent another market or personal use?" }, "answer": { "zh": "不能。它仅是这一具体美国公开标签的阅读入口；目标市场的现行文件和个人情况必须分别由专业人员核对。", "en": "No. It is only a reading entry point for this specific U.S. public label; the current target-market document and individual circumstances need separate professional review." } }, { "question": { "zh": "为什么不把 OTC 档案写成原始批准或原研结论？", "en": "Why does the OTC archive not state original approval or originator conclusions?" }, "answer": { "zh": "标签记录不足以证明这些结论。它们需要可追溯的产品、剂型、市场、时间和一手监管记录，并经人工审核。", "en": "A label record is insufficient to prove those conclusions. They require traceable product, dosage-form, market, date and primary regulatory records with human review." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "how-to-read-a-drug-label", "regulatory-sources-first" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/flonase-allergy-relief/", "en": "https://origindrug.com/en/drugs/flonase-allergy-relief/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "aleve", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-25", "status": "published_traceable_archive" }, "names": { "brand": "ALEVE", "generic": "萘普生钠", "aliases": [ "ALEVE", "naproxen", "naproxen sodium", "萘普生", "萘普生钠", "0280-0114-01", "0280-0114-02" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "疼痛与炎症", "sourceArchiveMarket": "美国：DailyMed 当前 ALEVE CAPLETS 公开标签（SPL v4，2026-03-12 更新）列示萘普生钠 220 mg（相当于萘普生 200 mg）的蓝色、胶囊形、无刻痕口服片，及多个准确瓶装 NDC。本页只展示 24 片与 200 片两组标签包装；不建立中国大陆、欧盟、日本或其他市场的商品名、批准、供应、可售资格、原研/仿制关系或可替代性。", "dosageFormClass": "萘普生钠口服片：每片标签标示萘普生钠 220 mg（标签同时注明相当于萘普生 200 mg；不是两个可相加的剂量）", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "NDA 020204（所引美国现行 OTC 标签列示；不据此推定其他市场状态）", "archiveSponsorText": "Bayer HealthCare LLC（所引美国现行公开标签所列）" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [ "Aleve liquid-filled capsule", "Aleve PM", "Aleve Back & Muscle", "other naproxen package", "萘普生钠软胶囊", "其他萘普生包装" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-aleve-naproxen-sodium-tablet-220mg-200-bottle-ndc-0280-0114-01", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v4（2026-03-12 更新）", "en": "DailyMed SPL v4 (updated 12 Mar 2026)" }, "dosageForm": { "zh": "无刻痕胶囊形口服片", "en": "unscored capsule-shaped oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [], "productCode": "NDC 0280-0114-01", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "ALEVE CAPLETS 萘普生钠 220 mg、200 片瓶装", "en": "ALEVE CAPLETS naproxen sodium 220 mg, 200-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=Aleve+Caplets+Blusheild+-+200+Count+Carton.jpg&setid=02941928-128a-2c88-e063-6294a90ac6ba&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "萘普生钠（每片）", "en": "Naproxen sodium (per tablet)" }, "value": 220, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；标签同时注明相当于萘普生 200 mg，不是两个可相加的量", "en": "Labelled amount per tablet; the label also states naproxen 200 mg equivalent, not two additive amounts" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": null, "package": { "count": 200, "unit": { "zh": "片", "en": "tablets" } }, "physicalClues": { "color": { "zh": "蓝色", "en": "blue" }, "shape": { "zh": "椭圆/胶囊形", "en": "oval/capsule-shaped" }, "imprint": { "zh": "Aleve", "en": "Aleve" }, "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_896c1a02d3db0626", "label": "DailyMed (NLM): ALEVE CAPLETS 220 mg, NDC 0280-0114-01, 200-tablet bottle panel (Bayer; SPL v4)", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=02941928-128a-2c88-e063-6294a90ac6ba&version=4", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-25", "reviewedAt": "2026-08-25" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-aleve-naproxen-sodium-tablet-220mg-24-bottle-ndc-0280-0114-02", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v4（2026-03-12 更新）", "en": "DailyMed SPL v4 (updated 12 Mar 2026)" }, "dosageForm": { "zh": "无刻痕胶囊形口服片", "en": "unscored capsule-shaped oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [], "productCode": "NDC 0280-0114-02", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "ALEVE CAPLETS 萘普生钠 220 mg、24 片瓶装", "en": "ALEVE CAPLETS naproxen sodium 220 mg, 24-tablet bottle" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "萘普生钠（每片）", "en": "Naproxen sodium (per tablet)" }, "value": 220, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；标签同时注明相当于萘普生 200 mg，不是两个可相加的量", "en": "Labelled amount per tablet; the label also states naproxen 200 mg equivalent, not two additive amounts" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": null, "package": { "count": 24, "unit": { "zh": "片", "en": "tablets" } }, "physicalClues": { "color": { "zh": "蓝色", "en": "blue" }, "shape": { "zh": "椭圆/胶囊形", "en": "oval/capsule-shaped" }, "imprint": { "zh": "Aleve", "en": "Aleve" }, "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_896c1a02d3db0626", "label": "DailyMed (NLM): ALEVE CAPLETS 220 mg, NDC 0280-0114-02, 24-tablet bottle listing (Bayer; SPL v4)", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=02941928-128a-2c88-e063-6294a90ac6ba&version=4", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-25", "reviewedAt": "2026-08-25" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-aleve-naproxen-sodium-tablet-220mg-200-bottle-ndc-0280-0114-01", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=Aleve+Caplets+Blusheild+-+200+Count+Carton.jpg&setid=02941928-128a-2c88-e063-6294a90ac6ba&type=img", "alt": "ALEVE CAPLETS 萘普生钠 220 mg、NDC 0280-0114-01、200 片瓶装在美国 DailyMed 现行公开标签中的包装图", "archiveMarket": "美国", "labelVersion": "DailyMed SPL v4（2026-03-12 更新）", "presentation": "ALEVE CAPLETS 萘普生钠：每片标签标示 220 mg，NDC 0280-0114-01，200 片瓶装（美国现行公开标签）。", "notice": "此图只对应所引美国 DailyMed 标签中的 ALEVE CAPLETS、萘普生钠 220 mg、NDC 0280-0114-01 与 200 片瓶装。它帮助核对品牌、成分、每片标示量、包装、外观和来源；不用于鉴定真伪，也不代表软胶囊、PM/复方、其他萘普生包装、其他 NSAID、其他市场、原研身份、可替代性或任何个人的服用、联用、停用、换药或分片方案。", "source": { "id": "src_896c1a02d3db0626", "label": "DailyMed (NLM): current U.S. ALEVE CAPLETS naproxen sodium public label (Bayer; SPL v4, updated 12 Mar 2026)", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=02941928-128a-2c88-e063-6294a90ac6ba&version=4", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-25", "reviewedAt": "2026-08-25" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "ALEVE／萘普生钠说明书放大阅读：先看清 220 mg 与“相当于 200 mg”", "en": "ALEVE label reading: first distinguish 220 mg from the stated 200 mg equivalent" }, "summary": { "zh": "本模块只阅读所引美国 OTC 标签中的 ALEVE CAPLETS、准确片剂、成分标示、NDC、包装、外形与警示。它不提供个人片数、服用间隔、停用、联用、换药、分片或购买方案。", "en": "This module reads only ALEVE CAPLETS, the exact tablet, labelled ingredient fields, NDC, package, appearance and warnings in the cited U.S. OTC label. It provides no individual tablet count, timing, stopping, co-use, switching, splitting or purchase plan." }, "checks": [ { "zh": "萘普生钠 220 mg 与标签括号中的萘普生 200 mg 是同一片剂的标示与活性部分等效信息，不是两份药量。不要把两个数字相加、换算成个人片数，或拿来和其他萘普生、布洛芬、阿司匹林或止痛产品自行比较。", "en": "Naproxen sodium 220 mg and the label’s parenthetical naproxen 200 mg refer to the same tablet’s labelled and active-moiety-equivalent information, not two medicine amounts. Do not add the numbers, convert them into a personal tablet count, or use them to self-compare another naproxen, ibuprofen, aspirin or pain product." }, { "zh": "所引 ALEVE 片为蓝色、无刻痕、胶囊形并压印 Aleve。外观只用于辅助核对；无刻痕不是分片许可，包装数量和“OTC”也不构成自行增加、轮换或与同类止痛药叠加的依据。", "en": "The cited ALEVE tablet is blue, unscored, capsule-shaped and imprinted Aleve. Appearance is only a supporting check; an unscored tablet is not splitting permission, and package count or OTC status does not justify self-increase, alternation or combination with another pain medicine." }, { "zh": "标签列出胃出血、心脏/卒中相关警示，并特别把 60 岁及以上、抗凝药或激素类药物、其他处方或非处方 NSAID、饮酒和肾脏/心血管问题列为需要专业核对的情境。请将所有药盒、非处方药、补充剂和酒精使用情况交给药师或医生；不要因品牌不同自行叠加。", "en": "The label includes stomach-bleeding and heart/stroke warnings, and specifically identifies age 60 or older, anticoagulant or steroid medicines, other prescription or OTC NSAIDs, alcohol, and kidney/cardiovascular conditions as contexts requiring professional review. Give every pack, OTC product, supplement and alcohol-use context to a pharmacist or clinician; different brands do not justify self-combining." }, { "zh": "黑便或血便、呕血、晕厥、胸痛、呼吸困难、单侧无力、言语含糊、面部肿胀或其他急性令人担心的问题，应优先使用当地紧急医疗支持；不要等待网页检索或同时改变多种药来试探原因。", "en": "With black or bloody stools, vomiting blood, fainting, chest pain, breathing difficulty, one-sided weakness, slurred speech, facial swelling or another acute worrying problem, prioritise local urgent medical support; do not wait for a webpage search or change several medicines to test the cause." } ], "source": { "id": "src_896c1a02d3db0626", "label": "DailyMed (NLM): current U.S. ALEVE CAPLETS public label (warnings and Drug Facts; Bayer; SPL v4)", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=02941928-128a-2c88-e063-6294a90ac6ba&version=4", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-25", "reviewedAt": "2026-08-25" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "萘普生钠怎样起作用：NSAID 类别术语不是自行联用规则", "en": "How naproxen sodium works: NSAID class terminology is not a self-combination rule" }, "summary": { "zh": "标签把萘普生钠归入 NSAID。本页用这一术语帮助读者识别类别与警示；不诊断疼痛或发热原因，也不判断是否应使用、与阿司匹林/布洛芬/塞来昔布等如何衔接、能否联用或何时停止。", "en": "The label classifies naproxen sodium as an NSAID. This page uses that term to help identify its class and warnings; it does not diagnose pain or fever, or decide whether to use it, how it relates to aspirin, ibuprofen or celecoxib, whether products can be combined, or when to stop." }, "checks": [ { "zh": "“同为 NSAID”是重复风险核对线索，不是可以互换或叠加的理由。每种实际产品、剂型、目标市场标签、完整药单和既往反应都需由专业人员一起核对。", "en": "“Same NSAID class” is a clue to check for duplication risk, not a reason to substitute or combine. Each actual product, dosage form, target-market label, complete medicine list and prior reaction needs professional review together." }, { "zh": "机制页不能解释个人的胃痛、黑便、头晕、血压、肾功能、胸痛、呼吸困难或其他症状，也不能替代对抗凝药、阿司匹林、其他止痛药、补充剂和饮酒情况的核对。", "en": "A mechanism page cannot explain an individual’s stomach pain, black stools, dizziness, blood pressure, kidney function, chest pain, breathing difficulty or another symptom, nor replace review of anticoagulants, aspirin, other pain medicines, supplements and alcohol use." }, { "zh": "出现急性严重或令人担心的不适时，应优先使用当地紧急医疗渠道；不要依据“NSAID”或包装文字自行改变多个产品。", "en": "With an acute severe or worrying problem, use local urgent medical pathways first; do not change several products yourself from an NSAID label or package text." } ], "source": { "id": "src_896c1a02d3db0626", "label": "DailyMed (NLM): current U.S. ALEVE CAPLETS public label (Drug Facts; Bayer; SPL v4)", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=02941928-128a-2c88-e063-6294a90ac6ba&version=4", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-25", "reviewedAt": "2026-08-25" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "ALEVE", "generic": "萘普生钠", "dosageFormClass": "萘普生钠口服片：每片标签标示萘普生钠 220 mg（标签同时注明相当于萘普生 200 mg；不是两个可相加的剂量）" }, "labelSource": { "id": "src_896c1a02d3db0626", "label": "DailyMed (NLM): current U.S. ALEVE CAPLETS naproxen sodium public label (Bayer; SPL v4, updated 12 Mar 2026)", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=02941928-128a-2c88-e063-6294a90ac6ba&version=4", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-25", "reviewedAt": "2026-08-25" }, "productRoutes": [ { "source": { "id": "src_896c1a02d3db0626", "label": "DailyMed (NLM): current U.S. ALEVE CAPLETS naproxen sodium public label (Bayer; SPL v4, updated 12 Mar 2026)", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=02941928-128a-2c88-e063-6294a90ac6ba&version=4", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-25", "reviewedAt": "2026-08-25" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-25", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-25", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "美国 DailyMed 当前 ALEVE CAPLETS 标签列示萘普生钠 220 mg（标签同时解释为萘普生 200 mg）、蓝色无刻痕胶囊形口服片和多种瓶装。本页先帮读者核对成分、两种标签数字、准确包装与公开说明书；“OTC”“止痛”或同为 NSAID 不能让它与布洛芬、阿司匹林、塞来昔布或其他产品自行叠加、轮换或替换。", "history": "所引标签为 Bayer HealthCare LLC 的美国 OTC 公开标签，SPL v4 更新于 2026-03-12。220 mg 萘普生钠与“相当于 200 mg 萘普生”是同一片剂的两个标签身份字段，不是两种成分或两个可相加的用药量；液体胶囊、PM/复方、其他萘普生包装和其他市场产品须另按准确标签核对。", "sourceDocuments": [ { "id": "src_896c1a02d3db0626", "label": "DailyMed (NLM): current U.S. ALEVE CAPLETS naproxen sodium public label (Bayer; SPL v4, updated 12 Mar 2026)", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=02941928-128a-2c88-e063-6294a90ac6ba&version=4", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-25", "reviewedAt": "2026-08-25" }, { "id": "src_5ed30b676fbb9773", "label": "FDA Drugs@FDA official search", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_lookup_entry", "documentKind": "regulatory_lookup", "market": "US", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } ], "applicationNumber": "NDA 020204（所引美国现行 OTC 标签列示）", "approvalTimeline": [ { "date": "NDA 020204", "title": { "zh": "FDA 标签所列美国初始批准年份", "en": "Initial U.S. approval year listed in the FDA label" }, "detail": { "zh": "本页链接的 FDA 标签档案列示 Initial U.S. Approval: NDA 020204。该历史定位不等同于当前批准、可得性、持有人或其他市场状态。", "en": "The FDA label archive linked here lists Initial U.S. Approval: NDA 020204. This historical locator is not a conclusion about current approval, availability, holder or another market." }, "source": { "id": "src_896c1a02d3db0626", "label": "DailyMed: ALEVE CAPLETS naproxen sodium U.S. public label", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=02941928-128a-2c88-e063-6294a90ac6ba&version=4", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-25", "reviewedAt": "2026-08-25" } }, { "date": "2026-03-12 updated public label (SPL v4)", "title": { "zh": "FDA 标签档案版本", "en": "FDA label archive version" }, "detail": { "zh": "本页链接 2026-03-12 updated public label (SPL v4) 的 FDA 标签档案作为可复核阅读入口。现行标签、规格、适应症和安全信息必须另行以目标市场当前文件核对。", "en": "This page links the 2026-03-12 updated public label (SPL v4) FDA label archive as a traceable reading entry point. Current labeling, strength, indication and safety information require separate verification against the target market’s current document." }, "source": { "id": "src_896c1a02d3db0626", "label": "DailyMed: ALEVE CAPLETS naproxen sodium U.S. public label", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=02941928-128a-2c88-e063-6294a90ac6ba&version=4", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-25", "reviewedAt": "2026-08-25" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "已链接公开标签档案", "en": "Public label archive linked" }, "detail": { "zh": "仅对应本页所列 FDA 文件。", "en": "Only the FDA document listed on this page is linked." } }, { "market": { "zh": "中国大陆、欧盟、日本", "en": "Mainland China, EU, Japan" }, "status": { "zh": "待逐项建立市场记录", "en": "Market record not established" }, "detail": { "zh": "不从美国标签档案推定当地批准、持有人、规格、供应或可售资格。", "en": "No local approval, holder, strength, supply or sale-eligibility conclusion is inferred from the U.S. label archive." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "标签档案能代表现在的产品信息吗？", "en": "Does a label archive represent current product information?" }, "answer": { "zh": "不能自动代表。档案用于定位来源；需要以目标市场的现行官方标签逐项复核。", "en": "Not automatically. The archive locates a source; each point needs verification against the target market’s current official label." } }, { "question": { "zh": "为什么这里不展示价格或原研/仿制结论？", "en": "Why are price and originator/generic conclusions not shown?" }, "answer": { "zh": "这些结论需要产品、剂型、规格、包装、市场、日期和原始记录分别齐全并经人工审核；单一标签文件不足以支持。", "en": "Those conclusions require separately complete and human-reviewed product, dosage-form, strength, pack, market, date and primary-record fields; one label file is insufficient." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "how-to-read-a-drug-label", "regulatory-sources-first" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/aleve/", "en": "https://origindrug.com/en/drugs/aleve/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "celebrex", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-23", "status": "published_traceable_archive" }, "names": { "brand": "Celebrex", "generic": "塞来昔布", "aliases": [ "celecoxib", "塞来昔布", "塞来昔布胶囊", "西乐葆" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": { "value": "西乐葆®", "status": "discovery_cue_requires_target_market_verification", "source": { "id": "src_dfb0d45af375cfae", "label": "江阴市人民政府：2025 年常用药品信息中的西乐葆／塞来昔布胶囊记录", "url": "https://www.jiangyin.gov.cn/doc/2025/01/24/1289505.shtml", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "government_medicine_listing", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-12", "reviewedAt": "2026-09-12" } } }, "identity": { "therapeuticArea": "疼痛与炎症", "sourceArchiveMarket": "美国 FDA 历史标签档案；另有 DailyMed 公开的 100 mg、100 粒瓶装面板（不推定实际可得性）", "dosageFormClass": "口服胶囊；本页精确包装面板仅为 100 mg 胶囊", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "1998（FDA/DailyMed Pfizer 2021 标签档案所列美国初始批准）", "archiveSponsorText": "Pfizer / FDA 历史监管档案；Viatris 的 DailyMed 公开标签面板" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-celebrex-celecoxib-capsule-100mg-100-count-bottle-ndc-58151-083-01", "marketCode": "US", "labelVersion": { "zh": "DailyMed 公开标签（2025 包装图稿；页面于 2026-08-23 复核）", "en": "DailyMed public label (2025 package artwork; source checked 23 Aug 2026)" }, "dosageForm": { "zh": "CELEBREX 塞来昔布口服胶囊", "en": "CELEBREX celecoxib oral capsule" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 58151-083-01", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_capsule", "primaryDisplay": { "zh": "每粒塞来昔布 100 mg；100 粒瓶装", "en": "Celecoxib 100 mg per capsule; 100-capsule bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=image-03.jpg&setid=2d6675e4-5859-4be2-8037-a20ce9f707aa&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "塞来昔布", "en": "celecoxib" }, "value": 100, "unit": "mg", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒标签标示量；不是个人粒数、联用、加减或换药规则", "en": "labelled amount per capsule; not an individual's capsule count, combination, adjustment or switching rule" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "100 粒瓶装", "en": "100-capsule bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-23", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "physicalClues": { "color": { "zh": "白色胶囊，胶囊体和帽上有蓝色带；包装标签主展示面", "en": "white capsule with blue bands on body and cap; bottle-label display panel" }, "shape": { "zh": "硬胶囊；印字 7767 / 100", "en": "hard capsule; imprint 7767 / 100" }, "imprint": null, "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_40a99a86ce8a28f2", "label": "DailyMed（NLM）：CELEBREX 塞来昔布 100 mg、100 粒瓶装美国公开标签面板（Viatris，2025 包装图稿）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=2d6675e4-5859-4be2-8037-a20ce9f707aa", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-celebrex-celecoxib-capsule-100mg-100-count-bottle-ndc-58151-083-01", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=image-03.jpg&setid=2d6675e4-5859-4be2-8037-a20ce9f707aa&type=img", "alt": "CELEBREX 100 mg 塞来昔布胶囊在美国 DailyMed 公开标签中的 100 粒瓶装标签图", "archiveMarket": "美国", "labelVersion": "DailyMed 公开标签（2025 包装图稿）", "presentation": "CELEBREX 塞来昔布 100 mg、100 粒瓶装标签图（DailyMed 公开标签所列）。", "notice": "此为美国 DailyMed 公开标签中明确对应 CELEBREX、塞来昔布 100 mg、NDC 58151-083-01、100 粒瓶装的标签图，只帮助核对品牌、通用名、标示强度、胶囊、包装数量与来源；不用于鉴定真伪，也不证明 50 mg、200 mg、400 mg、其他包装、其他市场标签、实际在售、原研身份、目标市场批准或可售资格。", "source": { "id": "src_40a99a86ce8a28f2", "label": "DailyMed（NLM）：CELEBREX 塞来昔布 100 mg、100 粒瓶装美国公开标签面板（Viatris，2025 包装图稿）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=2d6675e4-5859-4be2-8037-a20ce9f707aa", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "CELEBREX / 塞来昔布说明书放大阅读：先把胶囊、毫克数和同类药分开看", "en": "CELEBREX label reading: keep the capsule, milligram strength and related medicines distinct" }, "summary": { "zh": "本模块以 FDA 和 DailyMed 的 Pfizer 2021 美国 CELEBREX 历史标签档案为阅读入口，帮助核对 CELEBREX、celecoxib、口服胶囊、50/100/200/400 mg 及警告文字；它不提供个人剂量、止痛方案、联用、换药或停药建议。", "en": "This module uses the Pfizer 2021 U.S. FDA and DailyMed CELEBREX label archives as reading entry points. It helps check CELEBREX, celecoxib, oral capsules, 50/100/200/400 mg and warning language; it does not provide an individual dose, pain plan, combination, switch or stopping advice." }, "checks": [ { "zh": "先核对 CELEBREX、celecoxib、口服胶囊、目标市场和每粒标示强度。50、100、200、400 mg 首先是历史标签所列产品身份，不是“今天应吃几粒”的答案；不能据此自行拼量、替代或把别人的处方套用过来。", "en": "First check CELEBREX, celecoxib, oral capsule, target market and stated strength per capsule. 50, 100, 200 and 400 mg first identify products listed in the historical label; they are not an answer to “how many today,” and do not permit self-combining strengths, substitution or use of someone else’s prescription." }, { "zh": "历史标签提示同类 NSAID、水杨酸类和多种药物合用可能需要专业复核。不要因为包装都写“止痛”“消炎”或同属一类就自行叠加、隔日轮换或加用阿司匹林；带实际包装和完整药单请药师或医生逐项核对。", "en": "The historical label flags questions that can require professional review with related NSAIDs, salicylates and multiple medicines. Do not self-combine, alternate or add aspirin merely because packages say “pain” or “inflammation” or belong to a related class; bring actual packages and the complete medicine list for item-by-item pharmacist or clinician review." }, { "zh": "FDA/DailyMed 历史标签包含严重心血管与胃肠道风险警示，且写明老年人与既往消化道溃疡或出血史者的严重胃肠道事件风险更高。黑便、呕血、胸部不适、呼吸困难、晕厥或其他急性严重不适，应及时使用当地紧急医疗支持，而不是根据网页自行增减或换药。", "en": "The historical FDA/DailyMed labels contain serious cardiovascular and gastrointestinal warnings and state that older people and those with a prior peptic-ulcer or GI-bleeding history are at higher risk for serious GI events. With black stools, vomiting blood, chest discomfort, breathing trouble, fainting or another acute severe concern, use timely local urgent medical support rather than self-adjusting or switching from a webpage." }, { "zh": "胶囊能否打开、撒在食物上、混合、漏服后如何处理，必须只按准确产品与目标市场的现行标签、实际包装和药师建议逐项确认。即使历史标签记载过某一胶囊处理方式，也不能把它泛化到其他强度、其他品牌、其他胶囊或其他市场产品。", "en": "Whether a capsule may be opened, sprinkled on food, mixed, or managed after a missed dose must be confirmed item by item from the exact product, target market’s current label, actual pack and pharmacist advice. Even if a historical label records one capsule-handling method, it cannot be generalised to another strength, brand, capsule or market product." } ], "source": { "id": "src_4ceafb56ba5ca7ea", "label": "FDA：CELEBREX 2021 美国处方信息（NDA 020998）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020998s056lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "塞来昔布怎样起作用：标签将其列为选择性 COX-2 抑制剂", "en": "How celecoxib works: the label describes a selective COX-2 inhibitor" }, "summary": { "zh": "DailyMed 的 CELEBREX 历史标签将 celecoxib 描述为一种非甾体抗炎药（NSAID），并指向其选择性抑制环氧合酶-2（COX-2）的药理作用。这解释药理路径，不预测个人是否适用、疼痛原因、用量、联用、换药或停药。", "en": "The DailyMed CELEBREX historical label describes celecoxib as a nonsteroidal anti-inflammatory drug (NSAID) and points to selective inhibition of cyclooxygenase-2 (COX-2). This explains a pharmacologic pathway; it does not predict individual suitability, cause of pain, amount, combination, switching or stopping." }, "checks": [ { "zh": "“选择性 COX-2”或“NSAID”不是自行判断某种疼痛能否用药、该选哪一种止痛药或能否同日叠加的工具。病因、既往病史、全部药物、剂型和现行标签都需要专业人员一起判断。", "en": "“Selective COX-2” or “NSAID” is not a tool for deciding whether a pain problem needs medicine, which pain medicine to select or whether products can be combined on the same day. Cause, history, all medicines, dosage form and current label need professional review together." }, { "zh": "共同的抗炎或止痛路径不使 CELEBREX 与其他 NSAID、含水杨酸类成分的产品或复方感冒止痛产品可自行相加、轮换或替代。机制页面不能完成相互作用核对。", "en": "A shared anti-inflammatory or pain pathway does not make CELEBREX self-combinable, alternatable or substitutable with another NSAID, a salicylate-containing product or a combination cold/pain product. A mechanism page cannot complete an interaction review." }, { "zh": "机制不能把 50、100、200、400 mg 胶囊变成个人的加减量、长期使用或停用规则。考虑改变方案、使用多种药物，或出现新症状时，应带实际包装和完整药单取得当地药师、医生或紧急支持。", "en": "Mechanism cannot turn 50, 100, 200 or 400 mg capsules into a personal increase, decrease, long-term-use or stopping rule. With a contemplated change, multiple medicines or a new symptom, bring actual packages and the complete medicine list to local pharmacist, clinician or urgent support." } ], "source": { "id": "src_cb5d7c49b51c80d5", "label": "DailyMed（NLM）：CELEBREX 公开历史标签档案（临床药理）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=8d52185d-421f-4e34-8db7-f7676db2a226&version=36", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "Celebrex", "generic": "塞来昔布", "dosageFormClass": "口服胶囊；本页精确包装面板仅为 100 mg 胶囊" }, "labelSource": { "id": "src_4ceafb56ba5ca7ea", "label": "FDA：CELEBREX 2021 美国处方信息（NDA 020998）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020998s056lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "productRoutes": [ { "source": { "id": "src_4ceafb56ba5ca7ea", "label": "FDA：CELEBREX 2021 美国处方信息（NDA 020998）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020998s056lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_40a99a86ce8a28f2", "label": "DailyMed（NLM）：CELEBREX 塞来昔布 100 mg、100 粒瓶装美国公开标签面板（Viatris，2025 包装图稿）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=2d6675e4-5859-4be2-8037-a20ce9f707aa", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_cb5d7c49b51c80d5", "label": "DailyMed（NLM）：CELEBREX 公开历史标签档案（Pfizer，2021-04 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=8d52185d-421f-4e34-8db7-f7676db2a226&version=36", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [ { "id": "fda-2020-nsaid-pregnancy-20-weeks-celecoxib-safety-communication", "issuedAt": "2020-10-15", "status": "fda_class_safety_communication", "title": { "zh": "FDA 药物安全通讯：含塞来昔布的 NSAIDs 在妊娠约 20 周后的风险沟通", "en": "FDA Drug Safety Communication: NSAID risk communication in pregnancy at about 20 weeks or later, including celecoxib" }, "summary": { "zh": "FDA 于 2020-10-15 发布 NSAIDs 药物安全通讯，公告的产品表明确列出 celecoxib／Celebrex。该公告说明，妊娠约 20 周或之后使用 NSAIDs 可能与胎儿肾功能问题及羊水过少有关，并说明美国处方信息的相应更新方向；它是美国、特定日期的类别监管沟通，不代表任何人已发生问题，也不提供自行开始、停止、换药、减少剂量或以其他止痛药替代的结论。妊娠、疑似妊娠或镇痛用药问题，应连同准确产品、所在市场现行说明书和完整用药清单由开方团队或药师核对。", "en": "On 2020-10-15, FDA issued an NSAID Drug Safety Communication whose product table explicitly lists celecoxib/Celebrex. It says NSAID use at about 20 weeks of pregnancy or later may be associated with fetal kidney problems and low amniotic fluid, and describes related U.S. prescribing-information updates. This is a dated U.S. class regulatory communication; it does not establish that any person has a problem or support self-starting, stopping, switching, reducing, or replacing pain medicine. Pregnancy, suspected pregnancy, or pain-medicine questions require review of the exact product, current label for the relevant market, and complete medicine list with the prescribing team or pharmacist." }, "source": { "id": "src_a2dd38c41a9b7aa8", "label": "FDA：2020-10-15 NSAIDs 在妊娠约 20 周后使用的药物安全通讯（明确列出 celecoxib／Celebrex）", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/fda-recommends-avoiding-use-nsaids-pregnancy-20-weeks-or-later-because-they-can-result-low-amniotic", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "FDA 与 DailyMed 的 CELEBREX（celecoxib）历史美国标签档案列示口服胶囊及美国初始批准年份 1998。本页另建立 DailyMed 公开标签中一款准确的 100 mg、100 粒瓶装面板，帮助核对品牌、通用名、每粒标示量、NDC 与包装；不据此推定其他强度、其它包装、现行市场供应、其它市场批准、原研关系、价格或可售资格。", "history": "止痛或抗炎字样、同为 NSAID、相同通用名或相近 mg 都不足以建立可互换关系。品牌、通用名、胶囊剂型、标示强度、目标市场、标签版本和完整药单必须一起核对；不能从一张包装图或历史档案自行叠加、轮换、换药或调整。", "sourceDocuments": [ { "id": "src_40a99a86ce8a28f2", "label": "DailyMed（NLM）：CELEBREX 塞来昔布 100 mg、100 粒瓶装美国公开标签面板（Viatris，2025 包装图稿）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=2d6675e4-5859-4be2-8037-a20ce9f707aa", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_4ceafb56ba5ca7ea", "label": "FDA：CELEBREX 2021 美国处方信息（NDA 020998）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020998s056lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_cb5d7c49b51c80d5", "label": "DailyMed（NLM）：CELEBREX 公开历史标签档案（Pfizer，2021-04 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=8d52185d-421f-4e34-8db7-f7676db2a226&version=36", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_5ed30b676fbb9773", "label": "FDA Drugs@FDA 官方检索入口", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_lookup_entry", "documentKind": "regulatory_lookup", "market": "US", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } ], "applicationNumber": "NDA 020998", "approvalTimeline": [ { "date": "1998", "title": { "zh": "FDA 标签所列美国初始批准年份", "en": "Initial U.S. approval year listed in the FDA label" }, "detail": { "zh": "本页链接的 FDA 标签档案列示 Initial U.S. Approval: 1998。该历史定位不等同于当前批准、可得性、持有人或其他市场状态。", "en": "The FDA label archive linked here lists Initial U.S. Approval: 1998. This historical locator is not a conclusion about current approval, availability, holder or another market." }, "source": { "id": "src_4ceafb56ba5ca7ea", "label": "FDA: CELEBREX label archive", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020998s056lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, { "date": "2021", "title": { "zh": "FDA 标签档案版本", "en": "FDA label archive version" }, "detail": { "zh": "本页链接 2021 的 FDA 标签档案作为可复核阅读入口。现行标签、规格、适应症和安全信息必须另行以目标市场当前文件核对。", "en": "This page links the 2021 FDA label archive as a traceable reading entry point. Current labeling, strength, indication and safety information require separate verification against the target market’s current document." }, "source": { "id": "src_4ceafb56ba5ca7ea", "label": "FDA: CELEBREX label archive", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020998s056lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "已链接公开标签档案", "en": "Public label archive linked" }, "detail": { "zh": "仅对应本页所列 FDA 文件。", "en": "Only the FDA document listed on this page is linked." } }, { "market": { "zh": "中国大陆、欧盟、日本", "en": "Mainland China, EU, Japan" }, "status": { "zh": "待逐项建立市场记录", "en": "Market record not established" }, "detail": { "zh": "不从美国标签档案推定当地批准、持有人、规格、供应或可售资格。", "en": "No local approval, holder, strength, supply or sale-eligibility conclusion is inferred from the U.S. label archive." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "标签档案能代表现在的产品信息吗？", "en": "Does a label archive represent current product information?" }, "answer": { "zh": "不能自动代表。档案用于定位来源；需要以目标市场的现行官方标签逐项复核。", "en": "Not automatically. The archive locates a source; each point needs verification against the target market’s current official label." } }, { "question": { "zh": "为什么这里不展示价格或原研/仿制结论？", "en": "Why are price and originator/generic conclusions not shown?" }, "answer": { "zh": "这些结论需要产品、剂型、规格、包装、市场、日期和原始记录分别齐全并经人工审核；单一标签文件不足以支持。", "en": "Those conclusions require separately complete and human-reviewed product, dosage-form, strength, pack, market, date and primary-record fields; one label file is insufficient." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "how-to-read-a-drug-label", "regulatory-sources-first" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/celebrex/", "en": "https://origindrug.com/en/drugs/celebrex/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "mobic", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-25", "status": "published_traceable_archive" }, "names": { "brand": "Mobic", "generic": "美洛昔康", "aliases": [ "MOBIC", "meloxicam", "美洛昔康", "莫比可", "美洛昔康片" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": { "value": "莫比可®", "status": "discovery_cue_requires_target_market_verification", "source": { "id": "src_c9e0d5ed4526f791", "label": "周口市医疗保障局：2025 年零售药店药品价格信息中的莫比可／美洛昔康片 7.5 mg 记录", "url": "https://ylbzj.zhoukou.gov.cn/sitesources/ybj/page_pc/ztzl/kqzzylfwsfhhcjgzxzlzq/gsgg/article9de15cf3cd994d6b8e2ab0abc9c69b1b.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "government_medicine_listing", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-12", "reviewedAt": "2026-09-12" } } }, "identity": { "therapeuticArea": "疼痛与炎症", "sourceArchiveMarket": "美国 MOBIC（meloxicam）历史处方信息，2021-05 修订；FDA 文件明确提示该标签可能不是最新获批版本。本档案不以此推定中国大陆或其他市场的当前批准、供应或可得性。", "dosageFormClass": "口服片：7.5 mg、15 mg（FDA 2021 美国历史标签所列）", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "2000（FDA 标签所列美国初始批准）", "archiveSponsorText": "FDA 美国公开标签档案（MOBIC）" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [ "meloxicam oral suspension", "美洛昔康口服混悬液", "meloxicam capsule" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-mobic-meloxicam-tablet-7-5mg-100-bottle-ndc-0597-0029-01", "marketCode": "US", "labelVersion": { "zh": "FDA 美国历史处方信息（2021-05 修订；文件明确可能不是最新获批标签）", "en": "FDA U.S. historical prescribing information (revised May 2021; the document states it may not be the latest approved label)" }, "dosageForm": { "zh": "MOBIC 美洛昔康口服片", "en": "MOBIC meloxicam oral tablet" }, "route": { "zh": "口服（标签产品身份字段）", "en": "oral (label product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 0597-0029-01", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片 7.5 mg；100 片瓶装（美国历史标签）", "en": "7.5 mg per tablet; 100-tablet bottle (U.S. historical label)" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "美洛昔康", "en": "meloxicam" }, "value": 7.5, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "7.5 mg 为每片历史标签标示量；不是个人片数、频率或换算指令", "en": "7.5 mg is the historical labelled amount per tablet; not an individual's tablet count, frequency or conversion instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-25", "currentLabelDisplayed": false, "ndcDirectoryListed": false, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "浅黄色", "en": "pastel yellow" }, "shape": { "zh": "圆形、双凸、无包衣片", "en": "round, biconvex, uncoated tablet" }, "imprint": { "zh": "一面勃林格殷格翰标志；另一面 M", "en": "Boehringer Ingelheim logo on one face; M on the other" }, "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_6a23f2af3df82e63", "label": "FDA：MOBIC（meloxicam）美国历史处方信息（2021-05 修订；7.5 mg 100 片瓶装 NDC 与片剂外观）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020938s028lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-mobic-meloxicam-tablet-15mg-100-bottle-ndc-0597-0030-01", "marketCode": "US", "labelVersion": { "zh": "FDA 美国历史处方信息（2021-05 修订；文件明确可能不是最新获批标签）", "en": "FDA U.S. historical prescribing information (revised May 2021; the document states it may not be the latest approved label)" }, "dosageForm": { "zh": "MOBIC 美洛昔康口服片", "en": "MOBIC meloxicam oral tablet" }, "route": { "zh": "口服（标签产品身份字段）", "en": "oral (label product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 0597-0030-01", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片 15 mg；100 片瓶装（美国历史标签）", "en": "15 mg per tablet; 100-tablet bottle (U.S. historical label)" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "美洛昔康", "en": "meloxicam" }, "value": 15, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "15 mg 为每片历史标签标示量；不是个人片数、频率或换算指令", "en": "15 mg is the historical labelled amount per tablet; not an individual's tablet count, frequency or conversion instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-25", "currentLabelDisplayed": false, "ndcDirectoryListed": false, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "浅黄色", "en": "pastel yellow" }, "shape": { "zh": "长圆形、双凸、无包衣片", "en": "oblong, biconvex, uncoated tablet" }, "imprint": { "zh": "一面 15；另一面 M", "en": "15 on one face; M on the other" }, "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_6a23f2af3df82e63", "label": "FDA：MOBIC（meloxicam）美国历史处方信息（2021-05 修订；15 mg 100 片瓶装 NDC 与片剂外观）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020938s028lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "status": "withheld_repackaged_or_non_exact_visual", "title": { "zh": "已核验历史标签文字，但未保留可一一对应的官方包装图，故不展示包装图片", "en": "Historical-label text was reviewed, but no one-to-one official package image was retained, so no package visual is shown" }, "summary": { "zh": "本档案只保留 FDA 2021 年美国历史标签中的 MOBIC、美洛昔康、口服片与 7.5 mg／15 mg 文字；该文件明确可能不是最新获批标签。未将零售图、版本不明图、其他市场图或无法对应具体强度的图片呈现为准确原品牌包装，因此页面不展示包装图。", "en": "This dossier retains only MOBIC, meloxicam, oral tablets and 7.5 mg/15 mg wording from the FDA's 2021 U.S. historical label, which explicitly may not be the latest approved label. No retail image, version-uncertain image, another-market image or image without a specific strength match is presented as an exact original-brand pack, so no package visual is shown." }, "source": { "id": "src_6a23f2af3df82e63", "label": "FDA：MOBIC（meloxicam）美国历史处方信息（2021-05 修订）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020938s028lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "MOBIC 说明书放大阅读：7.5、15 mg 是历史片剂身份，不是“该吃几片”", "en": "MOBIC label reading: 7.5 and 15 mg identify historical tablets; they do not answer “how many tablets”" }, "summary": { "zh": "本模块只阅读 FDA 2021 年美国历史标签中的 MOBIC、美洛昔康、口服片与每片标示量。该文件明确可能不是最新获批标签；页面不提供个人片数、开始、停用、换药、联用或购买方案。", "en": "This module reads only MOBIC, meloxicam, oral tablets and labelled amounts per tablet in the FDA's 2021 U.S. historical label. The document explicitly may not be the latest approved label; this page provides no individual tablet count, initiation, stopping, switching, co-use or purchase plan." }, "checks": [ { "zh": "把 MOBIC、美洛昔康、口服片、实际强度和目标市场一起核对。7.5、15 mg 是该历史标签中每片的标示量，不是个人每天该用多少片，也不能据此把另一种止痛抗炎药、另一剂型或另一市场产品自行换算。", "en": "Check MOBIC, meloxicam, oral-tablet form, actual strength and target market together. The 7.5 and 15 mg figures are historical labelled amounts per tablet, not how many tablets anyone should use, and they cannot self-convert another anti-inflammatory pain medicine, form or market product." }, { "zh": "该标签提示避免把 MOBIC 与其他 NSAID 或水杨酸盐类产品自行并用，因为这类组合需要专业评估。若手上还有阿司匹林、布洛芬、塞来昔布、感冒止痛药、抗凝药、草本或补充剂，应把全部实际包装和完整药单交给药师或开方团队核对，而不是只按“止痛”字样判断。", "en": "The label flags that MOBIC should not be self-combined with other NSAIDs or salicylate products because such combinations require professional assessment. If aspirin, ibuprofen, celecoxib, cold/pain products, anticoagulants, herbs or supplements are also present, have a pharmacist or prescriber review every actual pack and the full medicine list rather than deciding from the word “pain.”" }, { "zh": "FDA 标签对严重心血管和胃肠道风险设有黑框警告，并提示高龄者发生严重胃肠道事件的风险更高。这些警示不能转成网页上的个人停药或换药指令；出现胸痛、呼吸困难、异常虚弱、言语不清、呕血、黑便或其他急性严重不适时，应使用当地紧急医疗渠道。", "en": "The FDA label carries boxed warnings about serious cardiovascular and gastrointestinal risks and notes a higher risk of serious gastrointestinal events in older people. These warnings cannot become an individual stop-or-switch instruction on a webpage; chest pain, shortness of breath, unusual weakness, slurred speech, vomiting blood, black stools or another acute serious concern require local urgent medical care." }, { "zh": "历史标签还列出肾功能、肝功能、既往溃疡或出血、心血管情况及多药并用等需专业复核的情形。它不取代手上准确产品的现行说明书；涉及掰开、漏用、调整或更换时，应先请药师或开方团队结合实际药盒和完整药单核对。", "en": "The historical label also identifies kidney and liver context, prior ulcer or bleeding, cardiovascular context and multiple medicines as situations needing professional review. It does not replace the current leaflet for the exact product in hand; for splitting, missed use, adjustment or switching, first have a pharmacist or prescribing team review the actual pack and full medicine list." } ], "source": { "id": "src_6a23f2af3df82e63", "label": "FDA: MOBIC (meloxicam) historical U.S. prescribing information (revised May 2021; tablet identity, boxed warnings and interactions)", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020938s028lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "美洛昔康怎样起作用：它影响前列腺素生成相关的 COX 路径", "en": "How meloxicam works: it affects COX pathways involved in prostaglandin production" }, "summary": { "zh": "FDA 2021 年标签说明，美洛昔康与其他 NSAID 一样，作用机制并未完全明确，但涉及抑制 COX-1 和 COX-2，并影响前列腺素合成。该机制解释一条药理路径，不判断个人疼痛原因、疗效、片数、联用、停用或替代。", "en": "The FDA's 2021 label says that, like other NSAIDs, meloxicam's mechanism is not completely understood but involves inhibition of COX-1 and COX-2 and affects prostaglandin synthesis. This explains one pharmacologic pathway; it does not determine an individual's pain cause, benefit, tablet count, co-use, stopping or replacement." }, "checks": [ { "zh": "“影响 COX/前列腺素”是机制用语，不表示不同 NSAID 可以自行叠加、轮换或按 mg 对等换算。名称、剂型、强度、既往反应、胃肠/心肾情况与完整药单都会影响专业人员的判断。", "en": "“Affects COX/prostaglandins” is mechanism wording; it does not permit self-combining, alternating or milligram-converting different NSAIDs. Name, form, strength, prior reactions, gastrointestinal/cardiac/kidney context and the full medicine list all affect professional review." }, { "zh": "同样是“止痛”或“抗炎”用途，不能说明手中两盒产品可以互换。即使通用名相同，不同市场、剂型、每片标示量和标签版本也应逐项核对。", "en": "A shared “pain” or “anti-inflammatory” purpose does not establish that two packs can be exchanged. Even with the same generic name, market, dosage form, labelled amount per tablet and label version need item-by-item review." }, { "zh": "机制页不替代药物警戒或相互作用核对。加入新处方、非处方止痛/感冒产品、抗凝药、草本或补充剂，或出现不适时，应带完整药单请药师或医疗团队审阅；紧急严重症状优先使用当地紧急医疗渠道。", "en": "A mechanism page does not replace pharmacovigilance or interaction review. When a new prescription, OTC pain/cold product, anticoagulant, herb or supplement is added, or a concerning symptom occurs, have a pharmacist or care team review the full medicine list; use local urgent-care channels first for an acute serious concern." } ], "source": { "id": "src_6a23f2af3df82e63", "label": "FDA: MOBIC (meloxicam) historical U.S. prescribing information (revised May 2021; Clinical Pharmacology)", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020938s028lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "Mobic", "generic": "美洛昔康", "dosageFormClass": "口服片：7.5 mg、15 mg（FDA 2021 美国历史标签所列）" }, "labelSource": { "id": "src_6a23f2af3df82e63", "label": "FDA: MOBIC (meloxicam) historical U.S. prescribing information (revised May 2021; the document states it may not be the latest approved label)", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020938s028lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "productRoutes": [ { "source": { "id": "src_6a23f2af3df82e63", "label": "FDA: MOBIC (meloxicam) historical U.S. prescribing information (revised May 2021; the document states it may not be the latest approved label)", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020938s028lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "FDA 的 2021 年美国历史标签将 MOBIC 列为美洛昔康口服片，并列出 7.5 mg、15 mg 两种每片标示量及各自 100 片瓶装 NDC。本页帮助读者把商品名、通用名、片剂、每片标示量、历史标签和药物警戒入口逐项对应；它不把毫克数字变成个人片数、开始、停用、联用、换药或购买建议。", "history": "FDA 文件列示 MOBIC 的美国初始批准年份为 2000，且页面明确提示该标签可能不是最新获批版本。该档案只定位这一美国历史文件；不同剂型、不同包装、不同市场或同通用名产品均应按实际药盒和目标市场现行官方资料分别核对。", "sourceDocuments": [ { "id": "src_6a23f2af3df82e63", "label": "FDA: MOBIC (meloxicam) historical U.S. prescribing information (revised May 2021; the document states it may not be the latest approved label)", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020938s028lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_5ed30b676fbb9773", "label": "FDA Drugs@FDA official lookup entry", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_lookup_entry", "documentKind": "regulatory_lookup", "market": "US", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } ], "applicationNumber": "NDA 020938", "approvalTimeline": [ { "date": "2000", "title": { "zh": "FDA 标签所列美国初始批准年份", "en": "Initial U.S. approval year listed in the FDA label" }, "detail": { "zh": "本页链接的 FDA 标签档案列示 Initial U.S. Approval: 2000。该历史定位不等同于当前批准、可得性、持有人或其他市场状态。", "en": "The FDA label archive linked here lists Initial U.S. Approval: 2000. This historical locator is not a conclusion about current approval, availability, holder or another market." }, "source": { "id": "src_6a23f2af3df82e63", "label": "FDA: MOBIC historical U.S. prescribing information", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020938s028lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, { "date": "2021-05", "title": { "zh": "FDA 标签档案版本", "en": "FDA label archive version" }, "detail": { "zh": "本页链接 2021-05 的 FDA 标签档案作为可复核阅读入口。现行标签、规格、适应症和安全信息必须另行以目标市场当前文件核对。", "en": "This page links the 2021-05 FDA label archive as a traceable reading entry point. Current labeling, strength, indication and safety information require separate verification against the target market’s current document." }, "source": { "id": "src_6a23f2af3df82e63", "label": "FDA: MOBIC historical U.S. prescribing information", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020938s028lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "已链接公开标签档案", "en": "Public label archive linked" }, "detail": { "zh": "仅对应本页所列 FDA 文件。", "en": "Only the FDA document listed on this page is linked." } }, { "market": { "zh": "中国大陆、欧盟、日本", "en": "Mainland China, EU, Japan" }, "status": { "zh": "待逐项建立市场记录", "en": "Market record not established" }, "detail": { "zh": "不从美国标签档案推定当地批准、持有人、规格、供应或可售资格。", "en": "No local approval, holder, strength, supply or sale-eligibility conclusion is inferred from the U.S. label archive." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "标签档案能代表现在的产品信息吗？", "en": "Does a label archive represent current product information?" }, "answer": { "zh": "不能自动代表。档案用于定位来源；需要以目标市场的现行官方标签逐项复核。", "en": "Not automatically. The archive locates a source; each point needs verification against the target market’s current official label." } }, { "question": { "zh": "为什么这里不展示价格或原研/仿制结论？", "en": "Why are price and originator/generic conclusions not shown?" }, "answer": { "zh": "这些结论需要产品、剂型、规格、包装、市场、日期和原始记录分别齐全并经人工审核；单一标签文件不足以支持。", "en": "Those conclusions require separately complete and human-reviewed product, dosage-form, strength, pack, market, date and primary-record fields; one label file is insufficient." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "how-to-read-a-drug-label", "regulatory-sources-first" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/mobic/", "en": "https://origindrug.com/en/drugs/mobic/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "tylenol-extra-strength", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-19", "status": "published_traceable_archive" }, "names": { "brand": "Tylenol Extra Strength", "generic": "对乙酰氨基酚", "aliases": [ "TYLENOL EXTRA STRENGTH", "Extra Strength Tylenol", "acetaminophen", "paracetamol", "APAP" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "疼痛与炎症", "sourceArchiveMarket": "美国当前 OTC monograph 标签；DailyMed SPL v16 于 2026-07-22 生效、2026-07-24 发布", "dosageFormClass": "口服薄膜衣片（标签称 caplet）：每片对乙酰氨基酚 500 mg；本档案精确展示 NDC 50580-937-50", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "美国 OTC monograph M013 当前标签档案（DailyMed SPL v16）", "archiveSponsorText": "Kenvue Brands LLC / DailyMed（NLM）当前公开 OTC 标签档案" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [ "Tylenol Extra Strength", "Extra Strength Tylenol" ], "excludedProductCues": [ "TYLENOL PM", "PM Extra Strength", "diphenhydramine", "phenylephrine", "dextromethorphan", "guaifenesin", "TYLENOL Nighttime", "TYLENOL Cold", "TYLENOL Cold + Flu", "TYLENOL Flu", "TYLENOL Sinus", "TYLENOL Cough", "TYLENOL Severe", "TYLENOL 8HR", "TYLENOL 8 HR", "Tylenol Extended Release", "TYLENOL 650 mg", "Children's TYLENOL", "Infants TYLENOL", "TYLENOL oral suspension", "TYLENOL chewable", "TYLENOL Rapid Release Gels", "TYLENOL Liquid Gels", "TYLENOL Dissolve Packs", "TYLENOL Adult Liquid", "TYLENOL Easy to Swallow", "TYLENOL Gentleglide", "50580-472", "compare to Tylenol", "repackaged" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-tylenol-extra-strength-500mg-ndc-50580-937-50", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v16；2026-07-22 生效，2026-07-24 发布", "en": "DailyMed SPL v16; effective 22 Jul 2026 and published 24 Jul 2026" }, "dosageForm": { "zh": "薄膜衣片（标签称 caplet）", "en": "film-coated caplet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 50580-937-50", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片 500 mg；每盒 50 袋，每袋 2 片", "en": "500 mg per caplet; 50 pouches, 2 caplets each" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=103d109d-f520-409c-8da2-eb6b0fbec891&name=tylenol-1.jpg&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "对乙酰氨基酚", "en": "acetaminophen" }, "value": 500, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签含量；不是个人服用片数", "en": "labelled amount per tablet/caplet; not an individual's tablet count" } } ], "concentration": null, "container": { "typeCode": "pouch_carton", "typeLabel": { "zh": "单袋装薄膜衣片外盒", "en": "carton of individual caplet pouches" }, "fill": null, "countPerPackage": 50, "countUnit": { "zh": "袋/盒", "en": "pouches per carton" }, "unitsPerContainer": { "count": 2, "unit": { "zh": "片/袋", "en": "caplets per pouch" } } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-19", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 50, "unit": { "zh": "袋/盒", "en": "pouches per carton" } }, "physicalClues": { "color": { "zh": "白色、红色印字", "en": "white with red print" }, "shape": { "zh": "19 mm 椭圆片", "en": "19 mm oval caplet" }, "imprint": "TYLENOL;500", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_5996c8561aae7112", "label": "DailyMed（NLM）：TYLENOL Extra Strength 当前美国公开标签（Kenvue；SPL v16）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=103d109d-f520-409c-8da2-eb6b0fbec891&version=16", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-tylenol-extra-strength-500mg-ndc-50580-937-50", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=103d109d-f520-409c-8da2-eb6b0fbec891&name=tylenol-1.jpg&type=img", "alt": "Tylenol Extra Strength 当前美国 DailyMed v16 标签中的 500 mg、NDC 50580-937-50、50 袋装包装展示面", "archiveMarket": "美国", "labelVersion": "DailyMed SPL v16（2026-07-22 生效；2026-07-24 发布）", "presentation": "Tylenol Extra Strength 对乙酰氨基酚 500 mg；NDC 50580-937-50；50 袋/盒，每袋 2 片", "notice": "此图只对应美国当前 v16 标签中的 NDC 50580-937-50 袋装展示。每袋 2 片是包装身份，不是个人一次服用量；它不代表 100 片瓶装、PM、感冒复方、8HR、儿童制剂、凝胶或其他市场，也不用于鉴定真伪。", "source": { "id": "src_5996c8561aae7112", "label": "DailyMed（NLM）：TYLENOL Extra Strength 当前美国公开标签（Kenvue；SPL v16）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=103d109d-f520-409c-8da2-eb6b0fbec891&version=16", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "TYLENOL Extra Strength 说明书放大阅读：先核对每片 500 mg 与重复成分", "en": "TYLENOL Extra Strength label reading: first check 500 mg per caplet and duplicate ingredients" }, "summary": { "zh": "本模块只帮助核对准确产品、每片成分、包装结构和 Drug Facts 警示；不提供个人片数、服用间隔、日程、最大量、漏用处理或换算。", "en": "This module only helps check the exact product, ingredient per caplet, package structure and Drug Facts warnings; it provides no personal tablet count, interval, schedule, maximum amount, missed-use action or conversion." }, "checks": [ { "zh": "检查其他处方药与非处方药是否也含对乙酰氨基酚；不同品牌名并不能排除重复成分。不能确定时，把所有药盒和完整药单交给药师或医生核对。", "en": "Check whether other prescription or OTC medicines also contain acetaminophen; different brand names do not rule out a duplicate ingredient. If uncertain, take every pack and the complete medicine list to a pharmacist or clinician." }, { "zh": "标签中的 4,000 mg/24 小时是严重肝损伤警告边界，不是推荐目标、个人上限计算器或网页用量方案。肝病、每日饮用三杯或以上酒精饮品、使用华法林等情况应先咨询医生或药师。", "en": "The label's 4,000 mg in 24 hours is a severe liver-damage warning boundary, not a target, personal-limit calculator or web regimen. Liver disease, three or more alcoholic drinks daily, warfarin and related situations require clinician or pharmacist review." }, { "zh": "本标签的年龄分组不能转成儿童个人剂量。12 岁以下、妊娠或哺乳，以及症状持续或加重时，应按准确标签联系医生或药师。", "en": "The label's age grouping cannot be turned into an individual child dose. For children under 12, pregnancy or breastfeeding, or persistent or worsening symptoms, use the exact label and contact a clinician or pharmacist." }, { "zh": "疑似过量时，即使暂时没有症状，也应立即寻求医疗帮助或联系当地毒物咨询/急救渠道；网页不能计算‘还可以吃多少’。", "en": "For suspected overdose, seek medical help or local poison-control/emergency support immediately even without symptoms; a webpage cannot calculate how much more could be taken." }, { "zh": "当前 Drug Facts 没有给出通用漏服规则；页面不会编造补服、加倍或改时间建议。该展示片无刻痕，标签也未授权网页判断能否掰开、压碎或研磨。", "en": "The current Drug Facts provides no general missed-use rule; this page does not invent a catch-up, double-use or timing instruction. This displayed caplet is unscored, and the label does not authorise a webpage to decide splitting, crushing or grinding." } ], "source": { "id": "src_5996c8561aae7112", "label": "DailyMed（NLM）：TYLENOL Extra Strength 当前美国公开标签（Kenvue；SPL v16）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=103d109d-f520-409c-8da2-eb6b0fbec891&version=16", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "对乙酰氨基酚的作用说明：公开标签不能替代个人判断", "en": "Acetaminophen action context: a public label does not replace individual assessment" }, "summary": { "zh": "本页只说明该产品属于含对乙酰氨基酚的非处方镇痛退热药；不会把类别说明变成个人适用性、片数、间隔或疗程。", "en": "This page only identifies the product as an OTC analgesic and fever reducer containing acetaminophen; it does not turn a category description into personal suitability, tablet count, interval or duration." }, "checks": [ { "zh": "相同用途或相同成分名不表示不同强度、延释、儿童液体、复方感冒药或 PM 产品可以自行互换。", "en": "A shared use or ingredient name does not make different strengths, extended-release forms, children's liquids, combination cold products or PM products self-interchangeable." }, { "zh": "包装上的 500 mg 是每片成分身份，不是从体重、症状或其他药物推导个人片数的公式。", "en": "The 500 mg on the package identifies ingredient amount per caplet; it is not a formula for deriving a personal tablet count from weight, symptoms or other medicines." }, { "zh": "急性严重不适、过敏、严重皮肤反应或疑似过量时，应使用当地医疗和急救支持，而不是等待网页给出方案。", "en": "For an acute serious concern, allergy, severe skin reaction or suspected overdose, use local medical and emergency support rather than wait for a web plan." } ], "source": { "id": "src_5996c8561aae7112", "label": "DailyMed（NLM）：TYLENOL Extra Strength 当前美国公开标签（Kenvue；SPL v16）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=103d109d-f520-409c-8da2-eb6b0fbec891&version=16", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "Tylenol Extra Strength", "generic": "对乙酰氨基酚", "dosageFormClass": "口服薄膜衣片（标签称 caplet）：每片对乙酰氨基酚 500 mg；本档案精确展示 NDC 50580-937-50" }, "labelSource": { "id": "src_5996c8561aae7112", "label": "DailyMed（NLM）：TYLENOL Extra Strength 当前美国公开标签（Kenvue；SPL v16）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=103d109d-f520-409c-8da2-eb6b0fbec891&version=16", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "productRoutes": [ { "source": { "id": "src_5996c8561aae7112", "label": "DailyMed（NLM）：TYLENOL Extra Strength 当前美国公开标签（Kenvue；SPL v16）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=103d109d-f520-409c-8da2-eb6b0fbec891&version=16", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "DailyMed 当前 v16 将本展示对象列为 Tylenol Extra Strength 对乙酰氨基酚 500 mg 薄膜衣 caplet，NDC 50580-937-50：每盒 50 袋、每袋 2 片。每袋片数是包装身份，不是一次服用片数。本页帮助核对品牌、成分、每片含量、包装和重复成分风险；不生成个人片数、间隔、日程、最大量、漏服补救或换算。", "history": "本档案只把 2026-07-22 生效、2026-07-24 发布的 DailyMed v16 当前包装图与 NDC 50580-937-50 绑定。历史 v15 的 100 片瓶装图 tylenol-01.jpg（archive 944219）不作为当前展示，也不与现行 tylenol-1.jpg 混配。", "sourceDocuments": [ { "id": "src_5996c8561aae7112", "label": "DailyMed（NLM）：TYLENOL Extra Strength 当前美国公开标签（Kenvue；SPL v16）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=103d109d-f520-409c-8da2-eb6b0fbec891&version=16", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_38bff872e618edee", "label": "FDA：OTC Monograph M013 Final Administrative Order OTC000027", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/omuf/Order/Final%20Administrative%20Order%20OTC000027_M013-Internal%20Analgesic.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "regulatory_reference", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } ], "applicationNumber": "OTC Monograph M013 / Final Order OTC000027", "approvalTimeline": [ { "date": "2026-07-22", "title": { "zh": "当前 DailyMed SPL v16 生效", "en": "Current DailyMed SPL v16 became effective" }, "detail": { "zh": "本档案将 v16 的精确 NDC、每片 500 mg 与 50 袋×每袋 2 片包装分开记录。OTC monograph 与 NDC 列示不等同于药品申请获批结论。", "en": "This dossier records the exact NDC, 500 mg per caplet and the 50-pouch × 2-caplet package separately. OTC monograph and NDC listing do not mean FDA approval." }, "source": { "id": "src_5996c8561aae7112", "label": "DailyMed: current TYLENOL Extra Strength public label, SPL v16", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=103d109d-f520-409c-8da2-eb6b0fbec891&version=16", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, { "date": "2026-07-24", "title": { "zh": "DailyMed 发布当前 v16", "en": "DailyMed published current v16" }, "detail": { "zh": "发布日期与标签生效日分开记录；当前包装图只绑定 NDC 50580-937-50。", "en": "Publication date remains separate from label effective date; the current package image is bound only to NDC 50580-937-50." }, "source": { "id": "src_5996c8561aae7112", "label": "DailyMed: current TYLENOL Extra Strength public label, SPL v16", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=103d109d-f520-409c-8da2-eb6b0fbec891&version=16", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, { "date": "OTC000027", "title": { "zh": "FDA M013 最终行政命令来源", "en": "FDA M013 final administrative order source" }, "detail": { "zh": "FDA 的 OTC000027 文件为 M013 内用镇痛药 monograph 的一手监管入口；该制度路径与药品申请获批记录分开。", "en": "FDA OTC000027 is a primary regulatory source for the M013 internal-analgesic monograph; this pathway remains distinct from an approved drug application." }, "source": { "id": "src_38bff872e618edee", "label": "FDA: OTC Monograph M013 Final Administrative Order OTC000027", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/omuf/Order/Final%20Administrative%20Order%20OTC000027_M013-Internal%20Analgesic.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "regulatory_reference", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "当前 OTC monograph 标签与精确包装已链接", "en": "Current OTC monograph label and exact package linked" }, "detail": { "zh": "截至 2026-08-19 已核对 SPL v16 与 NDC 50580-937-50；不据此声称药品申请获批、实际在售、库存或可获得性。", "en": "SPL v16 and NDC 50580-937-50 were reviewed through 19 Aug 2026; this does not establish FDA approval, actual marketing, stock or availability." } }, { "market": { "zh": "中国大陆及其他市场", "en": "Mainland China and other markets" }, "status": { "zh": "待逐项建立市场记录", "en": "Market record not established" }, "detail": { "zh": "不从美国标签外推当地品牌、批准、包装、供应或可替代性。", "en": "No local brand, approval, package, supply or interchangeability is inferred from the U.S. label." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "每袋 2 片是不是一次要吃 2 片？", "en": "Does two caplets per pouch mean two caplets per use?" }, "answer": { "zh": "不是。它只是包装身份。本页不提供个人片数、间隔或最大量；应按手上准确标签并咨询药师或医生。", "en": "No. It is package identity only. This page provides no personal tablet count, interval or maximum; use the exact label in hand and ask a pharmacist or clinician." } }, { "question": { "zh": "如果漏用，能补服或加倍吗？", "en": "Can a missed use be made up or doubled?" }, "answer": { "zh": "当前 Drug Facts 没有提供通用漏用规则，本页不会编造补服或加倍建议。", "en": "The current Drug Facts provides no general missed-use rule, so this page does not invent a catch-up or doubling instruction." } } ], "relatedMedicineChecks": [ { "target": { "id": "coumadin", "brand": "Coumadin", "generic": "华法林钠", "canonicalUrls": { "zh": "https://origindrug.com/drugs/coumadin/", "en": "https://origindrug.com/en/drugs/coumadin/" } }, "title": { "zh": "与 COUMADIN／华法林同在药单上时：止痛退热药也要先核对", "en": "When COUMADIN / warfarin is on the same list: an analgesic or fever medicine also needs review first" }, "summary": { "zh": "TYLENOL Extra Strength 的美国公开 Drug Facts 提示，正在使用华法林时应先咨询医生或药师。本卡片只提示把实际 TYLENOL 包装、华法林包装、其他止痛/感冒药、处方药、非处方药和补充剂交给负责团队核对；它不判断能否同服，也不建议自行停用、错开时间、替换或调整任何一种药。", "en": "The U.S. public Drug Facts for TYLENOL Extra Strength says to ask a doctor or pharmacist before use when taking warfarin. This card only signals that the actual TYLENOL pack, warfarin pack, other pain/cold products, prescription medicines, OTC products and supplements need review by the responsible team; it does not decide co-use or advise self-stopping, time-separation, replacement or adjustment of either medicine." }, "source": { "id": "src_5996c8561aae7112", "label": "DailyMed（NLM）：TYLENOL Extra Strength 当前美国公开标签（Kenvue；SPL v16）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=103d109d-f520-409c-8da2-eb6b0fbec891&version=16", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "review_complete_medicine_list_no_self_directed_change" } ], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "dosage-forms-are-part-of-medicine-identity", "how-to-read-a-drug-label" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/tylenol-extra-strength/", "en": "https://origindrug.com/en/drugs/tylenol-extra-strength/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "panadol-extra-strength", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-09-13", "status": "published_traceable_archive" }, "names": { "brand": "Panadol Extra Strength", "generic": "对乙酰氨基酚", "aliases": [ "PANADOL EXTRA STRENGTH", "Panadol 500", "PANADOL 500 mg", "必理痛加强型", "acetaminophen", "paracetamol", "APAP", "对乙酰氨基酚" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "疼痛与炎症", "sourceArchiveMarket": "美国：DailyMed SPL v8，2024-02-07 发布；本页精确对应 PANADOL Extra Strength 对乙酰氨基酚 500 mg 薄膜衣片的标签文件。该有日期文件不证明其他国家/地区、PANADOL 其他产品线或当前供应状态。", "dosageFormClass": "对乙酰氨基酚口服薄膜衣 caplet：每片 500 mg；本页精确展示 DailyMed 标签中的 NDC 0135-7011-04、100 片瓶装面板", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "美国 OTC monograph M013 有日期公开标签档案（DailyMed SPL v8）", "archiveSponsorText": "Haleon US Holdings LLC / DailyMed（NLM）有日期公开 OTC 标签档案" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [ "Panadol Extra Strength", "PANADOL EXTRA STRENGTH", "Panadol 500" ], "excludedProductCues": [ "PANADOL PM", "diphenhydramine", "PANADOL Cold", "PANADOL COLD AND FLU", "dextromethorphan", "phenylephrine", "chlorpheniramine", "PANADOL EXTRA caffeine", "Panadol suspension", "Panadol liquid", "Children's Panadol", "PANADOL 665", "extended release", "modified release" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-panadol-extra-strength-500mg-ndc-0135-7011-04", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v8；2024-02-07 发布", "en": "DailyMed SPL v8; published 7 Feb 2024" }, "dosageForm": { "zh": "薄膜衣 caplet", "en": "film-coated caplet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 0135-7011-04", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片 500 mg；100 片/瓶", "en": "500 mg per caplet; 100 caplets per bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=9d384e88-5c11-4600-ac6c-a38371570138&name=image-01.jpg", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "对乙酰氨基酚", "en": "acetaminophen" }, "value": 500, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签含量；不是个人服用片数", "en": "labelled amount per tablet/caplet; not an individual's tablet count" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "100 片瓶装", "en": "100-caplet bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "片/瓶", "en": "caplets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-19", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "片/瓶", "en": "caplets per bottle" } }, "physicalClues": { "color": { "zh": "标签图所示白色 caplet", "en": "white caplet as displayed in the label image" }, "shape": { "zh": "标签图所示 caplet", "en": "caplet as displayed in the label image" }, "imprint": null, "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_0a2074c250f9960e", "label": "DailyMed（NLM）：PANADOL Extra Strength 有日期美国公开标签（Haleon；SPL v8）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=9d384e88-5c11-4600-ac6c-a38371570138", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-panadol-extra-strength-500mg-ndc-0135-7011-04", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=9d384e88-5c11-4600-ac6c-a38371570138&name=image-01.jpg", "alt": "PANADOL Extra Strength 在 DailyMed 有日期美国标签中的对乙酰氨基酚 500 mg、NDC 0135-7011-04、100 片瓶装展示面", "archiveMarket": "美国", "labelVersion": "DailyMed SPL v8（2024-02-07 发布）", "presentation": "PANADOL Extra Strength 对乙酰氨基酚 500 mg；NDC 0135-7011-04；100 片瓶装", "notice": "此图只对应该美国有日期标签中的 PANADOL Extra Strength 500 mg、NDC 0135-7011-04、100 片瓶装。100 片是包装数量，不是一次或一天的个人用量；它不代表 PANADOL PM、感冒复方、含咖啡因产品、儿童液体、缓释/其他规格或其他市场，也不用于鉴定真伪。", "source": { "id": "src_0a2074c250f9960e", "label": "DailyMed（NLM）：PANADOL Extra Strength 有日期美国公开标签（Haleon；SPL v8）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=9d384e88-5c11-4600-ac6c-a38371570138", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "PANADOL Extra Strength 放大阅读：500 mg 是每片含量，先核对重复成分", "en": "PANADOL Extra Strength label reading: 500 mg is per caplet; check duplicate ingredients first" }, "summary": { "zh": "本模块帮助阅读准确产品、每片对乙酰氨基酚含量、100 片包装身份和该标签的 Drug Facts 警示；不提供个人片数、间隔、最大量、漏服补救或换算。", "en": "This module helps read the exact product, acetaminophen amount per caplet, the 100-caplet package identity and this label's Drug Facts warnings; it does not provide a personal caplet count, interval, maximum, missed-use instruction or conversion." }, "checks": [ { "zh": "PANADOL 名称下的 PM、感冒复方、含咖啡因产品、儿童液体和其他市场包装并不是本页这瓶 500 mg 片剂。名称相近或都写 PANADOL，不能证明成分相同或可自行替换。", "en": "PANADOL PM, cold combinations, caffeine-containing products, children's liquids and packs from other markets are not this 500 mg caplet record. A similar name or PANADOL branding does not establish matching ingredients or self-substitution." }, { "zh": "查看所有处方药和非处方药是否也含对乙酰氨基酚；不同品牌名不能排除重复成分。不能确定时，把所有药盒和完整药单交给药师或医生核对。", "en": "Check whether every prescription and OTC product also contains acetaminophen; different brands do not rule out a duplicate ingredient. If uncertain, have a pharmacist or clinician review every pack and the complete medicine list." }, { "zh": "标签中关于 24 小时上限、肝损伤、酒精、华法林或过敏/皮肤反应的文字是安全核对线索，不是网页为个人生成的用量目标、加量公式或换药方案。", "en": "The label's 24-hour limit, liver-damage, alcohol, warfarin and allergy/skin-reaction text are safety-review cues, not a web-generated target, escalation formula or switching plan for an individual." }, { "zh": "疑似过量时，即使暂时没有症状，也应立即使用当地医疗、急救或中毒咨询支持；不要等待网页计算“还能吃多少”。", "en": "For suspected overdose, use local medical, emergency or poison-information support immediately even without symptoms; do not wait for a webpage to calculate how much more could be taken." }, { "zh": "100 片是整瓶数量，500 mg 是每片成分含量；这两个数字不能相乘、相除或结合症状自行推导片数。是否可掰开、研碎或换成另一种剂型，必须以准确药盒的现行说明书和药师核对为准。", "en": "100 is the bottle count and 500 mg is ingredient amount per caplet. They cannot be multiplied, divided or combined with symptoms to derive a personal caplet count. Splitting, crushing or changing dosage form requires the current label for the exact pack and pharmacist review." } ], "source": { "id": "src_0a2074c250f9960e", "label": "DailyMed（NLM）：PANADOL Extra Strength 有日期美国公开标签（Haleon；SPL v8）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=9d384e88-5c11-4600-ac6c-a38371570138", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "对乙酰氨基酚的作用说明：药盒识别不等于个人用药决定", "en": "Acetaminophen context: pack identification is not an individual medicine decision" }, "summary": { "zh": "本页只将该准确产品识别为含对乙酰氨基酚的非处方镇痛退热产品；不会把类别说明变成个人适用性、片数、间隔或疗程。", "en": "This page only identifies the exact product as an OTC analgesic and fever reducer containing acetaminophen; it does not turn that category into personal suitability, caplet count, interval or duration." }, "checks": [ { "zh": "共同用途、共同成分或共同品牌词不表示 PANADOL 与其他对乙酰氨基酚产品、感冒复方、夜间产品或延释产品可以自行互换、叠加或轮换。", "en": "A shared purpose, ingredient or brand word does not establish that PANADOL and another acetaminophen, cold-combination, nighttime or extended-release product can be self-interchanged, combined or alternated." }, { "zh": "药盒上的 500 mg 是产品身份字段，不是从体重、疼痛、发热、年龄或其他药物推导个人片数的公式。", "en": "The 500 mg on the pack is a product-identity field, not a formula for deriving an individual's caplet count from weight, pain, fever, age or other medicines." }, { "zh": "出现严重不适、过敏/严重皮肤反应或疑似过量时，应优先使用当地医疗和急救支持。", "en": "For serious symptoms, an allergy/severe skin reaction or suspected overdose, prioritise local medical and emergency support." } ], "source": { "id": "src_0a2074c250f9960e", "label": "DailyMed（NLM）：PANADOL Extra Strength 有日期美国公开标签（Haleon；SPL v8）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=9d384e88-5c11-4600-ac6c-a38371570138", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "Panadol Extra Strength", "generic": "对乙酰氨基酚", "dosageFormClass": "对乙酰氨基酚口服薄膜衣 caplet：每片 500 mg；本页精确展示 DailyMed 标签中的 NDC 0135-7011-04、100 片瓶装面板" }, "labelSource": { "id": "src_0a2074c250f9960e", "label": "DailyMed（NLM）：PANADOL Extra Strength 有日期美国公开标签（Haleon；SPL v8）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=9d384e88-5c11-4600-ac6c-a38371570138", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "productRoutes": [ { "source": { "id": "src_0a2074c250f9960e", "label": "DailyMed（NLM）：PANADOL Extra Strength 有日期美国公开标签（Haleon；SPL v8）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=9d384e88-5c11-4600-ac6c-a38371570138", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "这份档案对应美国 DailyMed 有日期标签中的 PANADOL Extra Strength：对乙酰氨基酚 500 mg 薄膜衣片，展示 NDC 0135-7011-04、100 片瓶装。500 mg 是每片的成分含量，100 片是整瓶数量；两者都不是任何人一次应该吃几片的答案。先核对药盒、是否还有其他含对乙酰氨基酚产品和完整药单，再阅读准确说明书。", "history": "该页面保留 2024-02-07 发布的 DailyMed SPL v8 作为有日期美国公开文件。PANADOL 名称下还存在感冒复方、PM、含咖啡因、混悬液和其他市场产品；不能因共同品牌词或 500 mg 数字把它们合并、叠加或互换。", "sourceDocuments": [ { "id": "src_0a2074c250f9960e", "label": "DailyMed（NLM）：PANADOL Extra Strength 有日期美国公开标签（Haleon；SPL v8）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=9d384e88-5c11-4600-ac6c-a38371570138", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } ], "applicationNumber": "OTC Monograph M013 / DailyMed SPL v8 / NDC 0135-7011-04", "approvalTimeline": [ { "date": "2024-02-07", "title": { "zh": "DailyMed 公开 PANADOL Extra Strength SPL v8", "en": "DailyMed published PANADOL Extra Strength SPL v8" }, "detail": { "zh": "本档案以 DailyMed SPL v8 的有日期公开标签，逐项绑定 PANADOL Extra Strength、对乙酰氨基酚 500 mg 薄膜衣 caplet 与 NDC 0135-7011-04 的 100 片瓶装面板。OTC monograph、NDC 与标签文件是产品识别和来源阅读入口，不等同于药品申请获批结论。", "en": "This dossier uses the dated DailyMed SPL v8 to bind PANADOL Extra Strength, acetaminophen 500 mg film-coated caplets and the NDC 0135-7011-04 100-caplet-bottle panel. The OTC monograph, NDC and label are product-identification and source-reading entries, not an approved-drug-application conclusion." }, "source": { "id": "src_0a2074c250f9960e", "label": "DailyMed：PANADOL Extra Strength 有日期美国公开标签（Haleon；SPL v8）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=9d384e88-5c11-4600-ac6c-a38371570138", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "有日期 OTC 标签与一个精确包装面板已链接", "en": "Dated OTC label and one exact package panel linked" }, "detail": { "zh": "本页只展示 SPL v8 的 500 mg caplet 与 NDC 0135-7011-04、100 片瓶装面板；它不证明当前在售、库存、可获得性、其他 NDC 或其他包装状态。", "en": "This page displays only the SPL v8 500 mg caplet and NDC 0135-7011-04 100-caplet-bottle panel; it does not establish current marketing, stock, availability, another NDC or another package status." } }, { "market": { "zh": "中国大陆、其他 PANADOL 产品线及其他市场", "en": "Mainland China, other PANADOL lines and other markets" }, "status": { "zh": "明确分开或待逐项建立", "en": "Explicitly separate or not established" }, "detail": { "zh": "不从这份美国有日期标签推定当地品牌、批准、规格、包装、供应、可售资格、原研/仿制关系或可替代性；PM、感冒复方、含咖啡因、儿童液体和缓释/其他规格必须分别核对。", "en": "No local brand, approval, strength, package, supply, sale eligibility, originator/generic relationship or interchangeability is inferred from this dated U.S. label. PM, cold combinations, caffeine-containing products, children's liquids and modified-release/other strengths require separate checking." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "100 片瓶装是否表示一次要吃 100 片或可以按包装数字算用量？", "en": "Does a 100-caplet bottle mean 100 caplets should be taken at once or that package numbers can calculate use?" }, "answer": { "zh": "不是。100 片仅是该美国标签包装数量，500 mg 仅是每片成分含量。网页不提供个人片数、间隔、最大量、补服或换算；应按手中准确药盒的现行说明书，并在需要时请药师或医生核对。", "en": "No. 100 is only the package count in this U.S. label and 500 mg is only ingredient amount per caplet. The page provides no personal count, interval, maximum, catch-up instruction or conversion; use the current label for the exact pack in hand and obtain pharmacist or clinician review when needed." } }, { "question": { "zh": "PANADOL 与 TYLENOL 都写对乙酰氨基酚，能否直接互换或和感冒药一起吃？", "en": "If PANADOL and TYLENOL both say acetaminophen, can they be directly substituted or taken with a cold medicine?" }, "answer": { "zh": "不能仅凭共同成分或品牌类别自行决定。必须核对实际产品的市场、剂型、每单位含量、是否还有感冒/夜间/复方成分及完整药单；不要自行叠加、轮换、停用或用网页推导片数。", "en": "Not from a shared ingredient or brand category alone. Check the actual product's market, dosage form, amount per unit, possible cold/nighttime/combination ingredients and complete medicine list; do not self-combine, alternate, stop or derive a caplet count from a webpage." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "dosage-forms-are-part-of-medicine-identity", "how-to-read-a-drug-label" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/panadol-extra-strength/", "en": "https://origindrug.com/en/drugs/panadol-extra-strength/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "advil-tablets", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-19", "status": "published_traceable_archive" }, "names": { "brand": "Advil", "generic": "布洛芬", "aliases": [ "ADVIL TABLETS", "Advil Coated Tablets", "ibuprofen" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "疼痛与炎症", "sourceArchiveMarket": "美国当前 NDA 018989 非处方标签；DailyMed SPL v38 于 2026-03-12 生效、2026-03-16 发布", "dosageFormClass": "口服包衣片：每片布洛芬 200 mg；本档案精确展示 NDC 0573-0150-20 的 24 片瓶装", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "1984-05-18（DailyMed 当前标签所列美国营销起始节点）", "archiveSponsorText": "Haleon US Holdings LLC / DailyMed（NLM）当前公开 OTC 标签档案" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [ "Advil Tablets", "Advil Coated Tablets" ], "excludedProductCues": [ "ADVIL PM", "diphenhydramine", "acetaminophen", "ADVIL Liqui-Gels", "ADVIL Liqui Gels", "ADVIL Minis", "ADVIL liquid-filled capsule", "ADVIL Gel Caplets", "ADVIL Caplets", "ADVIL Dual Action", "ADVIL Cold", "ADVIL Cold & Sinus", "ADVIL Sinus", "ADVIL Flu", "Children's ADVIL", "Infants ADVIL", "ADVIL suspension", "ADVIL drops", "ADVIL Migraine", "ADVIL Targeted Relief", "ADVIL topical", "ADVIL ibuprofen sodium", "compare to Advil", "repackaged" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-advil-tablets-200mg-ndc-0573-0150-20", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v38；2026-03-12 生效，2026-03-16 发布", "en": "DailyMed SPL v38; effective 12 Mar 2026 and published 16 Mar 2026" }, "dosageForm": { "zh": "包衣片", "en": "coated tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 0573-0150-20", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片 200 mg；24 片瓶装", "en": "200 mg per tablet; 24-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=1a665e64-9f30-be37-4a83-38789f1f1e89&name=Advil+Tablets+24+ct.jpg", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "布洛芬", "en": "ibuprofen" }, "value": 200, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签含量；不是个人服用片数", "en": "labelled amount per tablet/caplet; not an individual's tablet count" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "24 片瓶装", "en": "24-tablet bottle" }, "fill": null, "countPerPackage": 24, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-19", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 24, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "粉棕色", "en": "pinkish brown" }, "shape": { "zh": "11 mm 圆片", "en": "11 mm round tablet" }, "imprint": "Advil", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_a0ff83312e9e0cbd", "label": "DailyMed（NLM）：ADVIL 布洛芬当前美国公开标签（Haleon；SPL v38）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=1a665e64-9f30-be37-4a83-38789f1f1e89", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-advil-tablets-200mg-ndc-0573-0150-20", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=1a665e64-9f30-be37-4a83-38789f1f1e89&name=Advil+Tablets+24+ct.jpg", "alt": "Advil 当前美国 DailyMed v38 标签中的布洛芬 200 mg、NDC 0573-0150-20、24 片瓶装包装展示面", "archiveMarket": "美国", "labelVersion": "DailyMed SPL v38（2026-03-12 生效；2026-03-16 发布）", "presentation": "Advil 布洛芬 200 mg 包衣片；NDC 0573-0150-20；24 片瓶装", "notice": "此图只对应美国当前标签中的圆形包衣片 24 片瓶装。它不代表 Liqui-Gels、caplet、PM、Dual Action、儿童液体、其他包装或其他市场，也不用于鉴定真伪或判断个人片数。", "source": { "id": "src_a0ff83312e9e0cbd", "label": "DailyMed（NLM）：ADVIL 布洛芬当前美国公开标签（Haleon；SPL v38）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=1a665e64-9f30-be37-4a83-38789f1f1e89", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "ADVIL 说明书放大阅读：200 mg 先确认准确包衣片，再核对 NSAID 重复", "en": "ADVIL label reading: 200 mg first identifies the exact coated tablet, then check duplicate NSAIDs" }, "summary": { "zh": "本模块只帮助核对准确 Advil 包衣片、每片布洛芬、包装及 Drug Facts 风险；不提供个人片数、间隔、疗程、漏用、停药或替代方案。", "en": "This module only helps check the exact Advil coated tablet, ibuprofen per tablet, package and Drug Facts risks; it provides no personal tablet count, interval, duration, missed-use, stopping or substitution plan." }, "checks": [ { "zh": "布洛芬属于非甾体抗炎药（NSAID）。检查阿司匹林、萘普生、布洛芬及其他止痛、感冒或处方药是否造成同类成分重复；不要因品牌不同就自行叠加。", "en": "Ibuprofen is a nonsteroidal anti-inflammatory drug (NSAID). Check aspirin, naproxen, ibuprofen and other pain, cold or prescription medicines for class or ingredient overlap; different brands do not permit self-combination." }, { "zh": "标签提示胃出血风险，尤其是 60 岁以上、有溃疡或出血史、使用抗凝药/类固醇/其他 NSAID 或饮酒较多的人。黑便、呕血、持续胃痛或晕厥应及时使用当地医疗支持。", "en": "The label warns about stomach bleeding, especially for people aged 60 or older, with ulcer or bleeding history, or using anticoagulants, steroids, other NSAIDs or more alcohol. Black stools, vomiting blood, persistent stomach pain or fainting warrants timely local medical support." }, { "zh": "肾脏疾病、利尿剂、多种心血管药或脱水等情况需要医生或药师结合完整药单复核；网页不会提供所谓安全肾功能阈值或个人方案。", "en": "Kidney disease, diuretics, multiple cardiovascular medicines or dehydration require clinician or pharmacist review of the complete medicine list; this page provides no supposed safe kidney threshold or personal plan." }, { "zh": "妊娠 20 周或以后使用 NSAID 需要按当前标签和 FDA 安全信息与专业人员讨论。页面不根据孕周自行判断能否使用。", "en": "NSAID use at 20 weeks of pregnancy or later requires discussion with a professional using the current label and FDA safety information. This page does not decide suitability from gestational age." }, { "zh": "若正在使用低剂量阿司匹林作预防，不要依据网页自行停用、错开或替换；把阿司匹林、布洛芬、萘普生和全部药盒交给医生或药师核对。", "en": "If low-dose aspirin is used for prevention, do not stop, space or replace it from a webpage; have a clinician or pharmacist review aspirin, ibuprofen, naproxen and every medicine pack together." } ], "source": { "id": "src_a0ff83312e9e0cbd", "label": "DailyMed（NLM）：ADVIL 布洛芬当前美国公开标签（Haleon；SPL v38）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=1a665e64-9f30-be37-4a83-38789f1f1e89", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "布洛芬怎样起作用：NSAID 类别说明不等于个人用药方案", "en": "How ibuprofen works: an NSAID class explanation is not an individual regimen" }, "summary": { "zh": "当前标签将布洛芬归入 NSAID。该类别说明帮助理解疼痛、炎症以及胃肠、心血管和肾脏风险为何需要一起核对；不会决定个人是否适用、片数、间隔或疗程。", "en": "The current label places ibuprofen in the NSAID class. That context helps explain why pain, inflammation, gastrointestinal, cardiovascular and kidney risks need review together; it does not determine personal suitability, tablet count, interval or duration." }, "checks": [ { "zh": "相同 NSAID 类别或相同 200 mg 不使另一种布洛芬、萘普生、阿司匹林或复方产品可以自行叠加或替换。", "en": "A shared NSAID class or 200 mg marking does not make another ibuprofen, naproxen, aspirin or combination product self-combinable or substitutable." }, { "zh": "包衣片、caplet、Liqui-Gels、儿童液体和外用产品属于不同产品身份，不能只凭品牌或通用名合并。", "en": "Coated tablets, caplets, Liqui-Gels, children's liquids and topical products are different product identities and cannot be collapsed by brand or generic name alone." }, { "zh": "胸痛、呼吸困难、突发无力、严重胃肠道出血表现、明显少尿或急性过敏等情况应使用当地紧急医疗支持。", "en": "Chest pain, breathing difficulty, sudden weakness, serious gastrointestinal bleeding signs, markedly reduced urine or acute allergy warrants local urgent medical support." } ], "source": { "id": "src_a0ff83312e9e0cbd", "label": "DailyMed（NLM）：ADVIL 布洛芬当前美国公开标签（Haleon；SPL v38）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=1a665e64-9f30-be37-4a83-38789f1f1e89", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "Advil", "generic": "布洛芬", "dosageFormClass": "口服包衣片：每片布洛芬 200 mg；本档案精确展示 NDC 0573-0150-20 的 24 片瓶装" }, "labelSource": { "id": "src_a0ff83312e9e0cbd", "label": "DailyMed（NLM）：ADVIL 布洛芬当前美国公开标签（Haleon；SPL v38）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=1a665e64-9f30-be37-4a83-38789f1f1e89", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "productRoutes": [ { "source": { "id": "src_a0ff83312e9e0cbd", "label": "DailyMed（NLM）：ADVIL 布洛芬当前美国公开标签（Haleon；SPL v38）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=1a665e64-9f30-be37-4a83-38789f1f1e89", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [ { "id": "fda-2020-nsaid-pregnancy-20-weeks-ibuprofen-advil-safety-communication", "issuedAt": "2020-10-15", "status": "fda_ingredient_class_safety_communication", "title": { "zh": "FDA 药物安全通讯：包括布洛芬的 NSAIDs 在妊娠约 20 周后的风险沟通", "en": "FDA Drug Safety Communication: NSAID risk communication in pregnancy at about 20 weeks or later, including ibuprofen" }, "summary": { "zh": "FDA 于 2020-10-15 发布 NSAIDs 药物安全通讯，明确列出 ibuprofen（布洛芬），并说明该风险沟通覆盖处方与非处方 NSAIDs：妊娠约 20 周或之后使用可能与胎儿肾功能问题和羊水过少有关。Advil 档案以布洛芬这一成分线索关联此美国、特定日期的类别监管沟通；它不表示任何一盒 Advil、任何其他布洛芬产品、其他市场或任何个人已发生问题，也不支持自行开始、停止、换药、改量或用另一种止痛药替代。妊娠、疑似妊娠、疼痛或发热相关问题，应连同准确产品、现行目标市场标签和完整药单由开方团队或药师核对。", "en": "On 2020-10-15, FDA issued an NSAID Drug Safety Communication that explicitly names ibuprofen and says the risk communication applies to prescription and over-the-counter NSAIDs: use at about 20 weeks of pregnancy or later may be associated with fetal kidney problems and low amniotic fluid. The Advil dossier links this dated U.S. class communication through ibuprofen as its active-ingredient clue. It does not mean that any Advil pack, another ibuprofen product, another market or any individual has a problem, and it does not support self-starting, stopping, switching, changing an amount or replacing pain medicine. Pregnancy, suspected pregnancy, pain or fever questions require review of the exact product, current target-market label and complete medicine list with the prescribing team or pharmacist." }, "source": { "id": "src_a2dd38c41a9b7aa8", "label": "FDA：2020-10-15 NSAIDs 在妊娠约 20 周后使用的药物安全通讯（明确列出 ibuprofen）", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/fda-recommends-avoiding-use-nsaids-pregnancy-20-weeks-or-later-because-they-can-result-low-amniotic", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "DailyMed 当前 v38 的 Advil 标签包含多种产品呈现；本档案只精确展示 NDC 0573-0150-20：布洛芬 200 mg 包衣片，24 片瓶装。页面帮助核对成分、片型、NDC、包装和 NSAID 重复风险；不生成个人片数、间隔、疗程、漏服处理、与阿司匹林的安排或换药建议。", "history": "Advil 的美国 NDA 018989 与 1984 年节点可由当前公开标签追溯。由于同一品牌家族包含 caplet、gel、PM、复方和儿童产品，本页只以准确 NDC、剂型和官方图绑定所选圆形包衣片。", "sourceDocuments": [ { "id": "src_a0ff83312e9e0cbd", "label": "DailyMed（NLM）：ADVIL 布洛芬当前美国公开标签（Haleon；SPL v38）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=1a665e64-9f30-be37-4a83-38789f1f1e89", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } ], "applicationNumber": "NDA 018989", "approvalTimeline": [ { "date": "1984-05-18", "title": { "zh": "当前标签所列美国营销起始节点", "en": "U.S. marketing start node listed in the current label" }, "detail": { "zh": "该节点用于追溯 NDA 018989 的美国产品历史，不说明其他市场或其他 Advil 家族产品。", "en": "This node supports U.S. product history for NDA 018989 and does not establish another market or another Advil-family product." }, "source": { "id": "src_a0ff83312e9e0cbd", "label": "DailyMed: current ADVIL public label, SPL v38", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=1a665e64-9f30-be37-4a83-38789f1f1e89", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, { "date": "2026-03-12 / 2026-03-16", "title": { "zh": "SPL v38 生效与发布时间", "en": "SPL v38 effective and publication dates" }, "detail": { "zh": "当前标签于 2026-03-12 生效、2026-03-16 发布；本档案只精确展示 NDC 0573-0150-20 的 24 片瓶装圆形包衣片。", "en": "The current label became effective 12 Mar 2026 and was published 16 Mar 2026; this dossier displays only the 24-tablet round coated-tablet bottle, NDC 0573-0150-20." }, "source": { "id": "src_a0ff83312e9e0cbd", "label": "DailyMed: current ADVIL public label, SPL v38", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=1a665e64-9f30-be37-4a83-38789f1f1e89", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "当前 NDA 018989 标签与一个精确包装已链接", "en": "Current NDA 018989 label and one exact package linked" }, "detail": { "zh": "截至 2026-08-19 已核对 SPL v38 与 NDC 0573-0150-20；不据此声称实际在售、库存或可获得性。", "en": "SPL v38 and NDC 0573-0150-20 were reviewed through 19 Aug 2026; this does not establish actual marketing, stock or availability." } }, { "market": { "zh": "其他 Advil 产品与其他市场", "en": "Other Advil products and other markets" }, "status": { "zh": "明确分开或待建立", "en": "Explicitly separate or not established" }, "detail": { "zh": "Liqui-Gels、caplet、PM、Dual Action、儿童液体及其他市场不并入本包衣片展示。", "en": "Liqui-Gels, caplets, PM, Dual Action, children's liquids and other markets are not merged into this coated-tablet presentation." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "正在使用阿司匹林，可以自己改用 Advil 或调整时间吗？", "en": "Can someone using aspirin self-switch to Advil or adjust timing?" }, "answer": { "zh": "不能由网页决定。不要自行停用预防性阿司匹林；应把阿司匹林、布洛芬、萘普生及完整药单交给医生或药师核对。", "en": "A webpage cannot decide this. Do not self-stop preventive aspirin; have a clinician or pharmacist review aspirin, ibuprofen, naproxen and the complete medicine list." } } ], "relatedMedicineChecks": [ { "target": { "id": "coumadin", "brand": "Coumadin", "generic": "华法林钠", "canonicalUrls": { "zh": "https://origindrug.com/drugs/coumadin/", "en": "https://origindrug.com/en/drugs/coumadin/" } }, "title": { "zh": "与 COUMADIN／华法林同在药单上时：抗凝药是需要优先核对的风险线索", "en": "When COUMADIN / warfarin is on the same list: an anticoagulant is a priority review cue" }, "summary": { "zh": "ADVIL 当前美国公开 Drug Facts 将正在使用抗凝药列为胃出血警示中需要留意的风险线索。本卡片只提示把实际 Advil 包装、华法林包装、其他止痛/感冒药、处方药、非处方药和补充剂交给负责团队核对；它不判断能否同服，也不建议自行停用、错开时间、替换或调整任何一种药。", "en": "The current U.S. public Drug Facts for ADVIL lists use of a blood-thinning anticoagulant as a risk cue in its stomach-bleeding warning. This card only signals that the actual Advil pack, warfarin pack, other pain/cold products, prescription medicines, OTC products and supplements need review by the responsible team; it does not decide co-use or advise self-stopping, time-separation, replacement or adjustment of either medicine." }, "source": { "id": "src_a0ff83312e9e0cbd", "label": "DailyMed（NLM）：ADVIL 布洛芬当前美国公开标签（Haleon；SPL v38）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=1a665e64-9f30-be37-4a83-38789f1f1e89", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "review_complete_medicine_list_no_self_directed_change" } ], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "dosage-forms-are-part-of-medicine-identity", "how-to-read-a-drug-label" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/advil-tablets/", "en": "https://origindrug.com/en/drugs/advil-tablets/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "zyloprim", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-21", "status": "published_traceable_archive" }, "names": { "brand": "ZYLOPRIM", "generic": "别嘌醇", "aliases": [ "ZYLOPRIM", "allopurinol", "别嘌醇" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "疼痛与炎症", "sourceArchiveMarket": "美国当前 ZYLOPRIM 别嘌醇公开标签（处方信息 2025-01 修订；DailyMed SPL v10）", "dosageFormClass": "口服片：100 mg、200 mg、300 mg（当前美国标签所列；本档案分别展示三种 90 片瓶装面板）", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "1966（当前美国标签所列 Initial U.S. Approval）", "archiveSponsorText": "Casper Pharma LLC / DailyMed（NLM）当前公开标签档案" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [ "allopurinol injection", "注射用别嘌醇" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-zyloprim-allopurinol-tablet-100mg-90-count-bottle-ndc-70199-031-90", "marketCode": "US", "labelVersion": { "zh": "处方信息 2025-01 修订；DailyMed SPL v10", "en": "Prescribing information revised Jan 2025; DailyMed SPL v10" }, "dosageForm": { "zh": "ZYLOPRIM 别嘌醇口服片", "en": "ZYLOPRIM allopurinol oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 70199-031-90", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片 100 mg；90 片瓶装", "en": "100 mg per tablet; 90-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?archiveid=867966&name=allopurinol-100mg-90ct.jpg", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "别嘌醇", "en": "allopurinol" }, "value": 100, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签量；不是个人片数、起始、加减或换药规则", "en": "labelled amount per tablet; not an individual's tablet count, start, adjustment or switching rule" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 90, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": null, "package": { "count": 90, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "白色至类白色", "en": "white to off-white" }, "shape": { "zh": "带斜边的凸起六角片", "en": "beveled raised hexagonal tablet" }, "imprint": "ZYLOPRIM 100", "scoreStatus": "functionally_scored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_bd9812c789502ffb", "label": "DailyMed（NLM）：ZYLOPRIM 别嘌醇当前美国公开标签（Casper Pharma；2025-01 修订，SPL v10）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=07d71f52-bafb-4307-a7cc-b52724151d42", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-zyloprim-allopurinol-tablet-200mg-90-count-bottle-ndc-70199-032-90", "marketCode": "US", "labelVersion": { "zh": "处方信息 2025-01 修订；DailyMed SPL v10", "en": "Prescribing information revised Jan 2025; DailyMed SPL v10" }, "dosageForm": { "zh": "ZYLOPRIM 别嘌醇口服片", "en": "ZYLOPRIM allopurinol oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 70199-032-90", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片 200 mg；90 片瓶装", "en": "200 mg per tablet; 90-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?archiveid=867966&name=allopurinol-200mg-90ct.jpg", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "别嘌醇", "en": "allopurinol" }, "value": 200, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签量；不是个人片数、起始、加减或换药规则", "en": "labelled amount per tablet; not an individual's tablet count, start, adjustment or switching rule" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 90, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": null, "package": { "count": 90, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "白色至类白色", "en": "white to off-white" }, "shape": { "zh": "双凸圆片", "en": "biconvex round tablet" }, "imprint": "ZYLOPRIM / 200", "scoreStatus": "functionally_scored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_bd9812c789502ffb", "label": "DailyMed（NLM）：ZYLOPRIM 别嘌醇当前美国公开标签（Casper Pharma；2025-01 修订，SPL v10）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=07d71f52-bafb-4307-a7cc-b52724151d42", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-zyloprim-allopurinol-tablet-300mg-90-count-bottle-ndc-70199-033-90", "marketCode": "US", "labelVersion": { "zh": "处方信息 2025-01 修订；DailyMed SPL v10", "en": "Prescribing information revised Jan 2025; DailyMed SPL v10" }, "dosageForm": { "zh": "ZYLOPRIM 别嘌醇口服片", "en": "ZYLOPRIM allopurinol oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 70199-033-90", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片 300 mg；90 片瓶装", "en": "300 mg per tablet; 90-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?archiveid=867966&name=allopurinol-300mg-90ct.jpg", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "别嘌醇", "en": "allopurinol" }, "value": 300, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签量；不是个人片数、起始、加减或换药规则", "en": "labelled amount per tablet; not an individual's tablet count, start, adjustment or switching rule" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 90, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": null, "package": { "count": 90, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "桃色", "en": "peach" }, "shape": { "zh": "带斜边的凸起六角片", "en": "beveled raised hexagonal tablet" }, "imprint": "ZYLOPRIM 300", "scoreStatus": "functionally_scored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_bd9812c789502ffb", "label": "DailyMed（NLM）：ZYLOPRIM 别嘌醇当前美国公开标签（Casper Pharma；2025-01 修订，SPL v10）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=07d71f52-bafb-4307-a7cc-b52724151d42", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-zyloprim-allopurinol-tablet-100mg-90-count-bottle-ndc-70199-031-90", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?archiveid=867966&name=allopurinol-100mg-90ct.jpg", "alt": "ZYLOPRIM 别嘌醇在美国 DailyMed 当前公开标签中的 100 mg、NDC 70199-031-90、90 片瓶装展示面", "archiveMarket": "美国", "labelVersion": "处方信息 2025-01 修订；DailyMed SPL v10", "presentation": "ZYLOPRIM 别嘌醇：每片 100 mg，NDC 70199-031-90，90 片瓶装展示面。", "notice": "此图只对应美国 DailyMed 当前标签中的 ZYLOPRIM、别嘌醇 100 mg、NDC 70199-031-90 与 90 片瓶装。它只帮助核对品牌、通用名、每片标签量、口服片、包装数量、外形线索与来源；不用于鉴定真伪，也不证明 200 mg、300 mg、其他包装、其他市场、当前可得性、原研身份或可替代性。标签所列功能性刻痕与毫克数均不是网页给个人的掰开、片数、开始、停用、联用或换药指令。", "source": { "id": "src_bd9812c789502ffb", "label": "DailyMed（NLM）：ZYLOPRIM 别嘌醇当前美国公开标签（Casper Pharma；2025-01 修订，SPL v10）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=07d71f52-bafb-4307-a7cc-b52724151d42", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "ZYLOPRIM 说明书放大阅读：100、200、300 mg 与刻痕先是片剂身份，不是“该吃几颗”", "en": "ZYLOPRIM label reading: 100, 200 and 300 mg plus scoring identify a tablet; they do not answer “how many tablets”" }, "summary": { "zh": "本模块以美国 DailyMed 当前公开标签为入口，帮助核对 ZYLOPRIM、别嘌醇、每片标签量、准确 NDC、90 片瓶装、片剂外形和目标市场。它不提供个人片数、起始、递增、漏用补救、掰开、停用、联用或换药方案。", "en": "This module uses the current U.S. DailyMed public label to check ZYLOPRIM, allopurinol, labelled amount per tablet, exact NDC, 90-tablet bottle, tablet appearance and target market. It provides no individual tablet count, initiation, increase, missed-use remedy, splitting, stopping, combination or switching plan." }, "checks": [ { "zh": "先把 ZYLOPRIM、别嘌醇、100/200/300 mg、实际 NDC、口服片和目标市场一起核对。毫克数是这一个准确片剂的标签量，不是任何人每天该吃几片的答案；同一通用名、另一种强度或另一种剂型也不能只按数字自行换算。", "en": "Check ZYLOPRIM, allopurinol, 100/200/300 mg, the actual NDC, oral-tablet form and target market together. Milligrams are the labelled amount in this exact tablet, not an answer to how many tablets anyone should take; a shared generic name, another strength or another dosage form cannot be self-converted from a number." }, { "zh": "当前标签描述三种片剂的外形、刻字和功能性刻痕。这些是产品身份线索，不是照片鉴定真伪的方法，也不是“可以自行掰半、补用或调整”的授权。实际包装、处方或吞咽情况与页面不同，应带着药盒向药师或开方团队核对。", "en": "The current label describes shape, imprint and functional scoring for the three tablet presentations. These are product-identity clues, not a way to authenticate a photograph or permission to self-split, make up or adjust use. If the actual pack, prescription or swallowing situation differs, take the pack to a pharmacist or prescribing team." }, { "zh": "标签将 HLA-B*58:01 与别嘌醇严重超敏反应风险联系起来，并说明检验的意义取决于开始治疗前后的情况与人群背景。网页不建议所有人做筛查，也不把阳性、阴性或既有基因报告变成个人能否开始、继续、停用或换药的结论；请带原始报告、实际药盒和完整药单请专业人员解释。", "en": "The label links HLA-B*58:01 with risk of severe allopurinol hypersensitivity and explains that the meaning of testing depends on timing around treatment and population context. This page neither recommends universal screening nor turns a positive, negative or existing genetic report into a conclusion about starting, continuing, stopping or switching; take the original report, actual pack and complete medicine list to a professional." }, { "zh": "当前标签列出噻嗪类利尿剂、氨苄西林、阿莫西林、硫唑嘌呤、巯嘌呤等需要特别核对的合并药线索。它不是一个可自行逐项停、加、错开或换药的清单；请把处方药、非处方药、补充剂和近期用药变化一并交给药师或医生。出现新的皮疹、水疱、口腔/眼部不适、发热、面唇肿胀、呼吸困难或其他急性严重问题时，优先使用当地紧急医疗与开方团队渠道，不要依赖网页自行处理或自行重新开始用药。", "en": "The current label flags thiazide diuretics, ampicillin, amoxicillin, azathioprine and mercaptopurine among co-medications requiring particular review. It is not a checklist for self-stopping, adding, spacing or switching products; give prescription medicines, OTC products, supplements and recent changes together to a pharmacist or clinician. With a new rash, blisters, mouth/eye discomfort, fever, lip/facial swelling, breathing difficulty or another acute severe concern, prioritise local urgent medical and prescribing-team pathways rather than self-managing from a webpage or self-restarting treatment." } ], "source": { "id": "src_bd9812c789502ffb", "label": "DailyMed（NLM）：ZYLOPRIM 别嘌醇当前美国公开标签（Warnings, Drug Interactions and Patient Counseling；Casper Pharma；SPL v10）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=07d71f52-bafb-4307-a7cc-b52724151d42", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "别嘌醇怎样起作用：它影响尿酸生成路径中的黄嘌呤氧化酶", "en": "How allopurinol works: it affects xanthine oxidase in a uric-acid production pathway" }, "summary": { "zh": "当前 ZYLOPRIM 标签将别嘌醇描述为黄嘌呤氧化酶抑制剂，并说明该酶参与次黄嘌呤、黄嘌呤到尿酸的转化；其代谢物奥昔嘌醇也抑制该酶。这个机制帮助读者理解药物作用路径，不诊断痛风、结石、关节痛或其他症状，也不决定个人是否适用、片数、起始、联用或换药。", "en": "The current ZYLOPRIM label describes allopurinol as a xanthine-oxidase inhibitor and explains that the enzyme participates in conversion of hypoxanthine and xanthine to uric acid; its metabolite oxypurinol also inhibits the enzyme. This explains a drug-action pathway, not gout, stones, joint pain or another symptom, and it does not decide individual suitability, tablet count, initiation, combination or switching." }, "checks": [ { "zh": "“影响尿酸生成路径”不等于任何关节痛、红肿、肾结石、化验数字或其他症状都由同一原因造成，也不表示网页可判断是否需要别嘌醇。诊断、检查、肾功能、完整药单和准确产品标签都必须由专业人员放在一起判断。", "en": "“Affects a uric-acid production pathway” does not mean every joint pain, redness, stone, laboratory number or other symptom has the same cause, or that a webpage can decide whether allopurinol is needed. Diagnosis, tests, kidney context, the complete medicine list and the exact product label must be considered together by a professional." }, { "zh": "同样影响尿酸、嘌呤或黄嘌呤氧化酶的产品，或名称中都含“尿酸”“嘌呤”，都不能证明可自行叠加、轮换、以 mg 等量换算或从一盒换到另一盒。不同品牌、强度、剂型、市场和合并药物需要逐项核对。", "en": "A product that also affects uric acid, purines or xanthine oxidase, or whose name includes similar words, does not prove that products can be self-combined, alternated, milligram-converted or replaced from one pack to another. Brand, strength, dosage form, market and co-medications require item-by-item review." }, { "zh": "机制不能决定基因检测、饮食、补液、化验频率、治疗时长、是否停用或如何处理漏用。若已有基因或检验报告，带原始资料、实际药瓶和完整药单与药师或医生讨论其是否与当前处方相关。", "en": "Mechanism cannot decide genetic testing, diet, fluid intake, testing frequency, treatment duration, whether to stop or how to handle missed use. If a genetic or laboratory report already exists, discuss whether it relates to the current prescription with a pharmacist or clinician using the original materials, actual bottle and complete medicine list." } ], "source": { "id": "src_bd9812c789502ffb", "label": "DailyMed（NLM）：ZYLOPRIM 别嘌醇当前美国公开标签（Clinical Pharmacology；Casper Pharma；SPL v10）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=07d71f52-bafb-4307-a7cc-b52724151d42", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "ZYLOPRIM", "generic": "别嘌醇", "dosageFormClass": "口服片：100 mg、200 mg、300 mg（当前美国标签所列；本档案分别展示三种 90 片瓶装面板）" }, "labelSource": { "id": "src_bd9812c789502ffb", "label": "DailyMed（NLM）：ZYLOPRIM 别嘌醇当前美国公开标签（Casper Pharma；2025-01 修订，SPL v10）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=07d71f52-bafb-4307-a7cc-b52724151d42", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "productRoutes": [ { "source": { "id": "src_bd9812c789502ffb", "label": "DailyMed（NLM）：ZYLOPRIM 别嘌醇当前美国公开标签（Casper Pharma；2025-01 修订，SPL v10）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=07d71f52-bafb-4307-a7cc-b52724151d42", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "美国 DailyMed 的 ZYLOPRIM 公开标签将其列为别嘌醇口服片，列有 100 mg、200 mg、300 mg 三种片剂。本页帮助核对商品名、通用名、每片标签量、准确 90 片瓶装面板、片剂外形线索、目标市场和标签版本；它不把任何毫克数字、刻痕、基因结果或相互作用文字转成个人片数、掰开、开始、停用、联用、换药或购买建议。", "history": "当前美国公开标签列示 Initial U.S. Approval: 1966，并在当前版本中列示 NDA 016084。这个档案只定位这份美国公开标签；同一通用名、不同品牌、不同强度、不同国家/地区、口服与注射产品或其他版本均须分别按当地现行资料核对。", "sourceDocuments": [ { "id": "src_bd9812c789502ffb", "label": "DailyMed（NLM）：ZYLOPRIM 别嘌醇当前美国公开标签（Casper Pharma；2025-01 修订，SPL v10）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=07d71f52-bafb-4307-a7cc-b52724151d42", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } ], "applicationNumber": "NDA 016084", "approvalTimeline": [ { "date": "1966", "title": { "zh": "当前标签所列美国初始批准年份", "en": "Initial U.S. approval year listed in the current label" }, "detail": { "zh": "当前 ZYLOPRIM 标签列示 Initial U.S. Approval: 1966。该年份只定位这一美国公开标签档案，不建立中国大陆、欧盟、日本或其他市场的批准、供应、可售资格、原研/仿制关系或个人适用性。", "en": "The current ZYLOPRIM label lists Initial U.S. Approval: 1966. This year locates this U.S. public-label archive only; it does not establish approval, supply, sale eligibility, originator/generic relationship or individual suitability in Mainland China, the EU, Japan or another market." }, "source": { "id": "src_bd9812c789502ffb", "label": "DailyMed（NLM）：ZYLOPRIM 别嘌醇当前美国公开标签（Casper Pharma；2025-01 修订，SPL v10）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=07d71f52-bafb-4307-a7cc-b52724151d42", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, { "date": "2025-01-09", "title": { "zh": "当前标签的有效日期与 SPL v10", "en": "Current label effective date and SPL v10" }, "detail": { "zh": "当前 ZYLOPRIM 标签页面列示处方信息修订于 2025-01、Effective Time 为 2025-01-09、Version 10。本页分别展示 100 mg、200 mg、300 mg 的 90 片瓶装面板；不据此建立实际在售、库存、个人片数、掰开、开始、停用、联用或换药结论。", "en": "The current ZYLOPRIM label page lists a Jan 2025 revision, effective time 9 Jan 2025 and Version 10. This page separately displays 90-tablet bottle panels for 100 mg, 200 mg and 300 mg; it does not establish actual availability, stock, individual tablet count, splitting, initiation, stopping, co-use or switching." }, "source": { "id": "src_bd9812c789502ffb", "label": "DailyMed（NLM）：ZYLOPRIM 别嘌醇当前美国公开标签（Casper Pharma；2025-01 修订，SPL v10）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=07d71f52-bafb-4307-a7cc-b52724151d42", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "已链接当前公开标签与三个准确 90 片瓶装面板", "en": "Current public label and three exact 90-tablet bottle panels linked" }, "detail": { "zh": "本页面板分别对应 NDC 70199-031-90（100 mg）、NDC 70199-032-90（200 mg）和 NDC 70199-033-90（300 mg）。它们不用于鉴定真伪，也不建立实际在售、库存、个人片数、掰开、开始、停用、联用或可替代性。", "en": "The panels correspond respectively to NDC 70199-031-90 (100 mg), NDC 70199-032-90 (200 mg) and NDC 70199-033-90 (300 mg). They do not authenticate a product or establish actual availability, stock, individual tablet count, splitting, initiation, stopping, co-use or interchangeability." } }, { "market": { "zh": "中国大陆、欧盟、日本及其他市场", "en": "Mainland China, EU, Japan and other markets" }, "status": { "zh": "待逐项建立市场记录", "en": "Market record not established" }, "detail": { "zh": "不从美国标签、NDC 或品牌名称推定当地商品名、批准、包装、供应、可售资格、原研/仿制关系或可替代性；任何市场版本均需按当地现行监管资料单独核对。", "en": "No local trade name, approval, packaging, supply, sale eligibility, originator/generic relationship or interchangeability is inferred from the U.S. label, NDC or brand name; every market version needs separate checking against current local regulatory information." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "ZYLOPRIM 100、200、300 mg 或带刻痕的片剂，是否表示可以自行掰开、增减或从一盒换到另一盒？", "en": "Do ZYLOPRIM 100, 200 or 300 mg tablets, or a scored tablet, mean that they can be self-split, adjusted or exchanged between packs?" }, "answer": { "zh": "不能。毫克数、外形、刻字和功能性刻痕都是准确片剂的标签身份信息，不是个人片数、掰开、补用、开始、停用或换药规则。应带实际药瓶、处方和完整药单让药师或开方团队核对。", "en": "No. Milligrams, shape, imprint and functional scoring are label-identity information for an exact tablet, not rules for individual tablet count, splitting, make-up use, initiation, stopping or switching. Take the actual bottle, prescription and complete medicine list to a pharmacist or prescribing team for review." } }, { "question": { "zh": "HLA-B*58:01 相关提示是否表示每个人都应做基因筛查，或可以凭报告自行开始/停用别嘌醇？", "en": "Does the HLA-B*58:01 information mean that everyone should be screened, or that a report can be used to self-start or stop allopurinol?" }, "answer": { "zh": "不表示。当前标签把该标记与严重超敏反应风险联系起来，但检验是否相关需结合治疗阶段、人群背景、肾功能、既往反应、完整药单和准确处方由专业人员判断。页面不建议普遍筛查，也不将任何报告替代临床复核。", "en": "No. The current label links this marker with severe hypersensitivity risk, but whether testing is relevant requires professional assessment of treatment stage, population context, kidney function, prior reactions, complete medicine list and the exact prescription. This page does not recommend universal screening or use any report in place of clinical review." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "dosage-forms-are-part-of-medicine-identity", "how-to-read-a-drug-label" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/zyloprim/", "en": "https://origindrug.com/en/drugs/zyloprim/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "uloric", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-25", "status": "published_traceable_archive" }, "names": { "brand": "ULORIC", "generic": "非布司他", "aliases": [ "ULORIC", "febuxostat", "非布司他" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "疼痛与炎症", "sourceArchiveMarket": "美国 ULORIC 非布司他当前公开标签（DailyMed SPL v17；页面 2025-12-24 更新；本档案只建立 NDC 64764-918-30 与 NDC 64764-677-30 两个 30 片瓶装面板）", "dosageFormClass": "口服片：40 mg、80 mg（当前美国公开标签所列；本档案分别展示两个 30 片瓶装面板）", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "2009（当前美国公开标签所列 Initial U.S. Approval）", "archiveSponsorText": "Takeda Pharmaceuticals America, Inc. / DailyMed（NLM）当前公开标签" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-uloric-febuxostat-tablet-40mg-30-count-bottle-ndc-64764-918-30", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（SPL v17；页面 2025-12-24 更新）", "en": "Current U.S. DailyMed public label (SPL v17; page updated 24 Dec 2025)" }, "dosageForm": { "zh": "ULORIC 非布司他口服片", "en": "ULORIC febuxostat oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 64764-918-30", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片 40 mg；30 片瓶装", "en": "40 mg per tablet; 30-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=uloric-02.jpg&setid=54de10ef-fe5f-4930-b91d-6bbb04c664bd&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "非布司他", "en": "febuxostat" }, "value": 40, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签量；不是个人片数、起始、加减或换药规则", "en": "labelled amount per tablet; not an individual's tablet count, initiation, adjustment or switching rule" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-25", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 30, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "浅绿色至绿色", "en": "light green to green" }, "shape": { "zh": "圆片", "en": "round tablet" }, "imprint": "TAP / 40", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_78c1393daf42afe9", "label": "DailyMed（NLM）：ULORIC 非布司他当前美国公开标签（Takeda Pharmaceuticals America；SPL v17，页面 2025-12-24 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=54de10ef-fe5f-4930-b91d-6bbb04c664bd&version=17", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-25", "reviewedAt": "2026-08-25" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-uloric-febuxostat-tablet-80mg-30-count-bottle-ndc-64764-677-30", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（SPL v17；页面 2025-12-24 更新）", "en": "Current U.S. DailyMed public label (SPL v17; page updated 24 Dec 2025)" }, "dosageForm": { "zh": "ULORIC 非布司他口服片", "en": "ULORIC febuxostat oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 64764-677-30", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片 80 mg；30 片瓶装", "en": "80 mg per tablet; 30-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=uloric-03.jpg&setid=54de10ef-fe5f-4930-b91d-6bbb04c664bd&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "非布司他", "en": "febuxostat" }, "value": 80, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签量；不是个人片数、起始、加减或换药规则", "en": "labelled amount per tablet; not an individual's tablet count, initiation, adjustment or switching rule" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-25", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 30, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "浅绿色至绿色", "en": "light green to green" }, "shape": { "zh": "泪滴形片", "en": "teardrop-shaped tablet" }, "imprint": "TAP / 80", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_78c1393daf42afe9", "label": "DailyMed（NLM）：ULORIC 非布司他当前美国公开标签（Takeda Pharmaceuticals America；SPL v17，页面 2025-12-24 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=54de10ef-fe5f-4930-b91d-6bbb04c664bd&version=17", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-25", "reviewedAt": "2026-08-25" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-uloric-febuxostat-tablet-40mg-30-count-bottle-ndc-64764-918-30", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=uloric-02.jpg&setid=54de10ef-fe5f-4930-b91d-6bbb04c664bd&type=img", "alt": "ULORIC 非布司他在美国 DailyMed 当前公开标签中的 40 mg、NDC 64764-918-30、30 片瓶装展示面", "archiveMarket": "美国", "labelVersion": "DailyMed 当前公开标签（SPL v17；页面 2025-12-24 更新）", "presentation": "ULORIC 非布司他：每片 40 mg，NDC 64764-918-30，30 片瓶装展示面。", "notice": "此图只对应美国 DailyMed 当前标签中的 ULORIC、非布司他 40 mg、NDC 64764-918-30 与 30 片瓶装。它只帮助核对品牌、通用名、每片标签量、口服片、包装数量、外形线索与来源；不用于鉴定真伪，也不证明 80 mg、其他包装、其他市场、实际可得性、原研身份或可替代性。毫克数和包装数字不是网页给个人的片数、开始、停用、联用或换药指令。", "source": { "id": "src_78c1393daf42afe9", "label": "DailyMed（NLM）：ULORIC 非布司他当前美国公开标签（Takeda Pharmaceuticals America；SPL v17，页面 2025-12-24 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=54de10ef-fe5f-4930-b91d-6bbb04c664bd&version=17", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-25", "reviewedAt": "2026-08-25" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "ULORIC 说明书放大阅读：40 mg、80 mg、NDC 与瓶装先用来核对准确片剂身份", "en": "ULORIC label reading: 40 mg, 80 mg, NDC and bottle first identify the exact tablet" }, "summary": { "zh": "本模块只阅读美国 DailyMed 当前公开标签中的 ULORIC、非布司他、40 mg 或 80 mg 每片标签量、准确 NDC、30 片瓶装和外形文字线索。它不提供个人片数、起始、递增、漏用补救、停用、联用、换药或购买方案。", "en": "This module reads only ULORIC, febuxostat, the 40 mg or 80 mg labelled amount per tablet, exact NDC, 30-tablet bottle and appearance text in the current U.S. DailyMed public label. It provides no individual tablet count, initiation, increase, missed-use remedy, stopping, co-use, switching or purchase plan." }, "checks": [ { "zh": "先把 ULORIC、非布司他、40 mg 或 80 mg、实际 NDC、30 片瓶装、口服片和目标市场一起核对。只看到“非布司他”或一个 mg 数字，不能证明另一强度、另一包装、另一品牌或另一市场产品相同。", "en": "Check ULORIC, febuxostat, 40 mg or 80 mg, the actual NDC, 30-tablet bottle, oral-tablet form and target market together. Seeing only “febuxostat” or one mg number does not prove that another strength, package, brand or market product is the same." }, { "zh": "40 mg、80 mg 和“30 片瓶装”是两个准确标签面板的身份文字，不是每天该吃几片、何时加减、是否漏用补回或是否可自行换到另一盒的说明。任何实际使用问题应带现行药盒、处方和完整药单请药师或开方团队核对。", "en": "The 40 mg, 80 mg and “30-tablet bottle” wording identifies two exact label panels; it does not say how many tablets to use, when to adjust, whether to make up a missed use or whether another pack can be self-switched. Take the current pack, prescription and full medicine list to a pharmacist or prescribing team for any real-use question." }, { "zh": "当前标签含有关于心血管死亡的加框警告，并把既往心血管情况和全部药单置于专业核对范围。该警告是阅读和求助线索，不让网页判断某个人能否继续、应否开始、停止或改用任何降尿酸产品。", "en": "The current label contains a boxed warning about cardiovascular death and places cardiovascular history and the complete medicine list within professional review. This warning is a reading and help-seeking cue; it does not let a webpage decide whether an individual should continue, start, stop or change any urate-lowering product." }, { "zh": "标签列出与硫唑嘌呤或巯嘌呤的禁忌；还应由药师或医生核对所有处方药、非处方药、补充剂、既往反应和准确产品。不要因看到相互作用或警告文字自行加、停、换、错开或补用任何药物。", "en": "The label lists contraindications with azathioprine or mercaptopurine; a pharmacist or clinician should also review every prescription medicine, OTC product, supplement, prior reaction and the exact product. Do not self-add, stop, switch, separate or make up any medicine because an interaction or warning appears on a webpage." } ], "source": { "id": "src_78c1393daf42afe9", "label": "DailyMed（NLM）：ULORIC 非布司他当前美国公开标签（Boxed Warning, Contraindications and Patient Counseling；Takeda Pharmaceuticals America；SPL v17）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=54de10ef-fe5f-4930-b91d-6bbb04c664bd&version=17", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-25", "reviewedAt": "2026-08-25" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "非布司他怎样在标签中被描述：黄嘌呤氧化酶抑制路径，不是个人用药规则", "en": "How febuxostat is described in the label: a xanthine-oxidase inhibition pathway, not an individual-use rule" }, "summary": { "zh": "当前美国标签将非布司他描述为黄嘌呤氧化酶抑制剂。这个机制帮助读者理解药物类别和尿酸生成相关的标签用语；它不诊断关节症状、预测个人尿酸变化、决定片数，或说明能否与别嘌醇、秋水仙碱或其他产品自行合并、替换或轮换。", "en": "The current U.S. label describes febuxostat as a xanthine oxidase inhibitor. This mechanism helps readers understand the drug class and label language related to uric-acid production; it does not diagnose joint symptoms, predict an individual's uric-acid change, determine tablet count or establish self-combination, replacement or alternation with allopurinol, colchicine or another product." }, "checks": [ { "zh": "“黄嘌呤氧化酶抑制”解释的是标签中的一个作用路径，不是从网页判断关节痛、红肿、尿酸检查结果或其他不适原因的工具。", "en": "“Xanthine oxidase inhibition” explains one pathway in the label; it is not a website tool for deciding the cause of joint pain, redness, a uric-acid test result or another symptom." }, { "zh": "同样与尿酸、痛风、炎症或黄嘌呤氧化酶相关的产品，不能因名称、类别或机制词相近就自行叠加、轮换、替代或按 mg 换算。", "en": "Products also related to uric acid, gout, inflammation or xanthine oxidase cannot be self-combined, alternated, substituted or milligram-converted because their names, classes or mechanism terms seem similar." }, { "zh": "机制说明不能决定是否需要某种治疗、何时开始、持续多久、是否漏用补回、是否停用或如何处理急性问题。实际问题必须回到准确产品的目标市场现行标签和专业人员。", "en": "A mechanism explanation cannot decide whether a treatment is needed, when to start, how long to continue, whether to make up a missed use, whether to stop or how to handle an acute concern. Real questions must return to the current target-market label for the exact product and a professional." } ], "source": { "id": "src_78c1393daf42afe9", "label": "DailyMed（NLM）：ULORIC 非布司他当前美国公开标签（Clinical Pharmacology；Takeda Pharmaceuticals America；SPL v17）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=54de10ef-fe5f-4930-b91d-6bbb04c664bd&version=17", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-25", "reviewedAt": "2026-08-25" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "ULORIC", "generic": "非布司他", "dosageFormClass": "口服片：40 mg、80 mg（当前美国公开标签所列；本档案分别展示两个 30 片瓶装面板）" }, "labelSource": { "id": "src_78c1393daf42afe9", "label": "DailyMed（NLM）：ULORIC 非布司他当前美国公开标签（Takeda Pharmaceuticals America；SPL v17，页面 2025-12-24 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=54de10ef-fe5f-4930-b91d-6bbb04c664bd&version=17", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-25", "reviewedAt": "2026-08-25" }, "productRoutes": [ { "source": { "id": "src_78c1393daf42afe9", "label": "DailyMed（NLM）：ULORIC 非布司他当前美国公开标签（Takeda Pharmaceuticals America；SPL v17，页面 2025-12-24 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=54de10ef-fe5f-4930-b91d-6bbb04c664bd&version=17", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-25", "reviewedAt": "2026-08-25" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-25", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-25", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "美国 DailyMed 的当前 ULORIC 公开标签将其列为非布司他口服片，列有 40 mg、80 mg 两种片剂及对应的 30 片瓶装面板。本页帮助核对商品名、通用名、每片标签量、准确 NDC、外形线索、目标市场和原始标签；它不把毫克数、包装数字、警告或相互作用文字转成个人片数、开始、停用、联用、换药或购买建议。", "history": "当前美国公开标签列示 Initial U.S. Approval: 2009。该年份和页面状态只定位所引美国标签；同一通用名的其他品牌、其他强度、其他包装、其他国家/地区版本或其他降尿酸产品，均须按准确产品和目标市场现行资料分别核对。", "sourceDocuments": [ { "id": "src_78c1393daf42afe9", "label": "DailyMed（NLM）：ULORIC 非布司他当前美国公开标签（Takeda Pharmaceuticals America；SPL v17，页面 2025-12-24 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=54de10ef-fe5f-4930-b91d-6bbb04c664bd&version=17", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-25", "reviewedAt": "2026-08-25" } ], "applicationNumber": "NDA 021856", "approvalTimeline": [ { "date": "2009", "title": { "zh": "当前标签所列美国初始批准年份", "en": "Initial U.S. approval year listed in the current label" }, "detail": { "zh": "当前 ULORIC 标签列示 Initial U.S. Approval: 2009。该年份只定位所引美国标签历史，不建立中国大陆、欧盟、日本或其他市场的批准、供应、可售资格、原研/仿制关系或个人适用性。", "en": "The current ULORIC label lists Initial U.S. Approval: 2009. This year only locates the cited U.S. label history; it does not establish approval, supply, sale eligibility, originator/generic relationship or individual suitability in Mainland China, the EU, Japan or another market." }, "source": { "id": "src_78c1393daf42afe9", "label": "DailyMed（NLM）：ULORIC 非布司他当前美国公开标签（Takeda Pharmaceuticals America；SPL v17）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=54de10ef-fe5f-4930-b91d-6bbb04c664bd&version=17", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-25", "reviewedAt": "2026-08-25" } }, { "date": "2025-12-24", "title": { "zh": "DailyMed 当前公开标签页面更新", "en": "Current DailyMed public-label page updated" }, "detail": { "zh": "DailyMed 将该 ULORIC 当前公开标签页面的 Updated 日期列为 2025-12-24，版本为 SPL v17。本页只分别展示 40 mg、NDC 64764-918-30 与 80 mg、NDC 64764-677-30 的 30 片瓶装面板；不据此建立实际在售、库存、购买、个人片数、联用、停用、换药或其他市场状态。", "en": "DailyMed lists 24 Dec 2025 as the Updated date for this current ULORIC public-label page, version SPL v17. This page separately displays the 30-tablet bottle panels for 40 mg/NDC 64764-918-30 and 80 mg/NDC 64764-677-30; it does not establish actual availability, stock, purchase, individual tablet count, co-use, stopping, switching or another-market status." }, "source": { "id": "src_78c1393daf42afe9", "label": "DailyMed（NLM）：ULORIC 非布司他当前美国公开标签（Takeda Pharmaceuticals America；SPL v17，页面 2025-12-24 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=54de10ef-fe5f-4930-b91d-6bbb04c664bd&version=17", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-25", "reviewedAt": "2026-08-25" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "已链接当前公开标签与两组准确 30 片瓶装面板", "en": "Current public label and two exact 30-tablet bottle panels linked" }, "detail": { "zh": "本页分别展示 ULORIC 非布司他 40 mg、NDC 64764-918-30 与 80 mg、NDC 64764-677-30 的 30 片瓶装。它不用于鉴定真伪，也不建立实际在售、库存、购买、个人片数、开始、停用、联用、换药或可替代性。", "en": "This page separately displays the ULORIC febuxostat 40 mg/NDC 64764-918-30 and 80 mg/NDC 64764-677-30 30-tablet bottles. It does not authenticate a product or establish actual availability, stock, purchase, individual tablet count, initiation, stopping, co-use, switching or interchangeability." } }, { "market": { "zh": "中国大陆、欧盟、日本及其他市场", "en": "Mainland China, EU, Japan and other markets" }, "status": { "zh": "待逐项建立市场记录", "en": "Market record not established" }, "detail": { "zh": "不从美国标签、NDA、NDC、英文品牌、包装图或标签主体推定当地商品名、批准、包装、供应、可售资格、原研/仿制关系或可替代性；每个市场均须按当地现行监管资料单独核对。", "en": "No local trade name, approval, packaging, supply, sale eligibility, originator/generic relationship or interchangeability is inferred from the U.S. label, NDA, NDC, English brand, package image or label entity; every market requires separate checking against current local regulatory material." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "40 mg、80 mg 与 30 片瓶装能否用来自己决定片数、换到另一种强度或另一种降尿酸产品？", "en": "Can 40 mg, 80 mg and a 30-tablet bottle be used to decide my own tablet count or switch to another strength or urate-lowering product?" }, "answer": { "zh": "不能。这些字段只识别所引美国标签中的准确 ULORIC 片剂和包装。共同通用名、相近毫克数、包装照片或同属降尿酸领域，均不建立自行开始、增加、补用、停用、联用、轮换或替代关系；请带现行药盒、处方和完整药单请药师或开方团队复核。", "en": "No. These fields only identify the exact ULORIC tablets and packages in the cited U.S. label. A shared generic name, a nearby milligram number, a package photo or the same urate-lowering area does not establish self-initiation, increase, make-up use, stopping, co-use, alternation or substitution; take the current pack, prescription and complete medicine list to a pharmacist or prescribing team for review." } }, { "question": { "zh": "为什么页面强调心血管警告和完整药单，却不告诉我是否该改药？", "en": "Why does the page emphasise the cardiovascular warning and complete medicine list without telling me whether to change medicine?" }, "answer": { "zh": "这是当前美国标签中加框警告、禁忌和相互作用段落的阅读入口，不是个体化风险判断或治疗决策。出现急性严重不适或对现行处方有担忧时，请使用当地医疗支持；药师或医生需要结合准确产品、病史、检查和完整药单逐项复核。", "en": "It is a reading entry point for the current U.S. label's boxed warning, contraindications and interaction sections, not an individual risk assessment or treatment decision. For an acute serious concern or worry about the current prescription, use local medical support; a pharmacist or clinician needs the exact product, history, tests and complete medicine list for item-by-item review." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "dosage-forms-are-part-of-medicine-identity", "how-to-read-a-drug-label" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/uloric/", "en": "https://origindrug.com/en/drugs/uloric/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "colcrys", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-23", "status": "published_traceable_archive" }, "names": { "brand": "COLCRYS", "generic": "秋水仙碱", "aliases": [ "COLCRYS", "colchicine", "秋水仙碱" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "疼痛与炎症", "sourceArchiveMarket": "美国 COLCRYS 秋水仙碱有日期历史公开标签（2025-07 修订；公开产品记录列示 2026-04-30 美国营销结束）。本页只保留一个 0.6 mg、NDC 64764-119-07、30 片瓶装展示面。", "dosageFormClass": "口服片：每片秋水仙碱 0.6 mg（历史标签的 30 片瓶装展示面）", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "1961（美国公开历史标签所列 Initial U.S. Approval）", "archiveSponsorText": "Takeda Pharmaceuticals America, Inc. / DailyMed（NLM）有日期历史公开标签" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [ "colchicine injection", "秋水仙碱注射剂", "COLCRYS MITIGARE", "MITIGARE" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-colcrys-colchicine-tablet-0-6mg-30-count-bottle-ndc-64764-119-07", "marketCode": "US", "labelVersion": { "zh": "DailyMed 美国有日期历史公开标签（Takeda；2025-07 修订；产品记录列示 2026-04-30 营销结束）", "en": "Dated U.S. DailyMed historical public label (Takeda; revised Jul 2025; product record lists marketing end 30 Apr 2026)" }, "dosageForm": { "zh": "COLCRYS 秋水仙碱口服片", "en": "COLCRYS colchicine oral tablet" }, "route": { "zh": "口服（历史标签产品身份字段）", "en": "oral (historical-label product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 64764-119-07", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片 0.6 mg；30 片瓶装", "en": "0.6 mg per tablet; 30-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=colcrys-03.jpg&archiveid=902339", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "秋水仙碱", "en": "colchicine" }, "value": 0.6, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片历史标签量；不是个人片数、开始、停用、联用或换药规则", "en": "historical labelled amount per tablet; not an individual's tablet count, start, stop, co-use or switching rule" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-23", "currentLabelDisplayed": false, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 30, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "紫色", "en": "purple" }, "shape": { "zh": "椭圆/胶囊形片；有刻痕", "en": "oval/capsule-shaped tablet; scored" }, "imprint": "AR 374", "scoreStatus": "functionally_scored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_66091bc6932d4d52", "label": "DailyMed（NLM）：COLCRYS 秋水仙碱美国有日期历史公开标签（Takeda；2025-07 修订；产品记录列示 2026-04-30 营销结束）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=56c130d1-7581-4152-99a2-0014ee9366c0", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-colcrys-colchicine-tablet-0-6mg-30-count-bottle-ndc-64764-119-07", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=colcrys-03.jpg&archiveid=902339", "alt": "COLCRYS 秋水仙碱美国 DailyMed 有日期历史公开标签中的 0.6 mg、NDC 64764-119-07、30 片瓶装展示面", "archiveMarket": "美国", "labelVersion": "2025-07 修订；公开产品记录列示 2026-04-30 美国营销结束", "presentation": "COLCRYS 秋水仙碱：每片 0.6 mg，NDC 64764-119-07，30 片瓶装历史标签展示面。", "notice": "此图只对应美国 DailyMed 有日期历史标签中的 COLCRYS、秋水仙碱 0.6 mg、NDC 64764-119-07 与 30 片瓶装；公开产品记录列示该美国记录的营销结束日期为 2026-04-30。它只帮助核对品牌、通用名、每片历史标签量、口服片、包装数量、外形线索与来源；不用于鉴定真伪，也不证明当前在售、库存、购买、其他包装、其他市场、原研身份、可替代性或任何个人使用方案。标签所列刻痕与毫克数不是网页给个人的掰开、片数、开始、停用、联用或换药指令。", "source": { "id": "src_66091bc6932d4d52", "label": "DailyMed（NLM）：COLCRYS 秋水仙碱美国有日期历史公开标签（Takeda；2025-07 修订；产品记录列示 2026-04-30 营销结束）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=56c130d1-7581-4152-99a2-0014ee9366c0", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "COLCRYS 历史标签放大阅读：0.6 mg、NDC 与 30 片瓶装只先核对历史身份", "en": "COLCRYS historical-label reading: 0.6 mg, NDC and a 30-tablet bottle first identify a historical product" }, "summary": { "zh": "本模块只阅读一份美国有日期历史公开标签中的 COLCRYS、秋水仙碱、每片 0.6 mg、NDC 64764-119-07、30 片瓶装和外形文字线索。该记录列示美国营销结束日期为 2026-04-30；页面不提供个人片数、开始、停用、补用、掰开、联用、换药或购买方案。", "en": "This module reads only COLCRYS, colchicine, 0.6 mg per tablet, NDC 64764-119-07, a 30-tablet bottle and appearance text in one dated U.S. historical public label. The record lists a U.S. marketing end date of 30 Apr 2026; this page provides no individual tablet count, initiation, stopping, make-up use, splitting, co-use, switching or purchase plan." }, "checks": [ { "zh": "先把 COLCRYS、秋水仙碱、0.6 mg、实际 NDC、30 片瓶装、口服片和目标市场一起核对。0.6 mg 是这个准确历史片剂的标签量，不是任何人该吃几片或是否可以换到另一种产品的答案。", "en": "Check COLCRYS, colchicine, 0.6 mg, the actual NDC, the 30-tablet bottle, oral-tablet form and target market together. 0.6 mg is the labelled amount for this exact historical tablet, not an answer to how many tablets anyone should use or whether another product can be exchanged." }, { "zh": "紫色、AR 374、椭圆/胶囊形与刻痕均是历史标签中这一准确片剂的身份线索。它们不能鉴定照片真伪，也不是自行掰开、补用、加减、停用或换药的许可。实际包装、处方或市场与页面不同时，应带着药盒请药师或开方团队核对。", "en": "Purple colour, AR 374, the oval/capsule shape and scoring are identity clues for this exact historical labelled tablet. They cannot authenticate a photo and are not permission to self-split, make up, adjust, stop or switch. If the actual pack, prescription or market differs, take the pack to a pharmacist or prescribing team." }, { "zh": "历史标签特别提示强 P-gp 或 CYP3A4 抑制剂相关相互作用风险，并要求把所有处方药、非处方药、补充剂与近期新增抗菌药等一起核对。肾脏或肝脏问题、年长、多病共存或多药并用时，更不应从网页自行开始、增加、重复、停用或换药；应由药师或医生结合准确产品与完整药单复核。", "en": "The historical label flags interaction risk with strong P-gp or CYP3A4 inhibitors and calls for review of every prescription medicine, OTC product, supplement and recent addition such as an antibacterial. With kidney or liver problems, older age, multiple conditions or multiple medicines, do not self-start, increase, repeat, stop or switch from a webpage; a pharmacist or clinician should review the exact product and complete medicine list." }, { "zh": "出现严重腹泻或呕吐、明显无力、肌肉疼痛或无力、麻木刺痛、异常出血/瘀斑、发热、感染样表现、呼吸困难或其他急性严重不适时，应及时使用当地紧急医疗渠道；不要根据网页自行判断原因或调整药物。", "en": "With severe diarrhoea or vomiting, marked weakness, muscle pain or weakness, numbness or tingling, unusual bleeding/bruising, fever, infection-like symptoms, breathing difficulty or another acute serious concern, promptly use local urgent medical care; do not use a webpage to determine the cause or adjust medicine." } ], "source": { "id": "src_66091bc6932d4d52", "label": "DailyMed（NLM）：COLCRYS 秋水仙碱美国有日期历史公开标签（Warnings, Drug Interactions and Patient Counseling；Takeda；2025-07 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=56c130d1-7581-4152-99a2-0014ee9366c0", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "秋水仙碱怎样在标签中被描述：与微管蛋白结合的作用路径，不是个人用药规则", "en": "How colchicine is described in the label: a tubulin-binding pathway, not an individual-use rule" }, "summary": { "zh": "这份有日期历史标签在临床药理部分描述秋水仙碱与微管蛋白结合，并影响微管聚合与炎症过程中的细胞活动。它帮助理解标签用语中的作用路径，不诊断关节痛、炎症或其他症状，也不决定任何人的片数、开始、停用、联用或换药。", "en": "In Clinical Pharmacology, this dated historical label describes colchicine binding to tubulin and affecting microtubule polymerisation and cell activity in inflammatory processes. It helps explain a label term, not diagnose joint pain, inflammation or another symptom, and it does not determine anyone's tablet count, initiation, stopping, co-use or switching." }, "checks": [ { "zh": "“与微管蛋白结合”是标签中的机制描述，不表示网页能够判断某个疼痛、红肿、腹泻、肌肉症状或化验变化是否由这款药、痛风或其他原因造成。", "en": "“Binds to tubulin” is a mechanism description in the label; it does not mean a webpage can decide whether pain, redness, diarrhoea, muscle symptoms or a laboratory change is caused by this medicine, gout or another cause." }, { "zh": "同样涉及炎症、关节痛、尿酸或细胞过程的药物，不能因为名称、用途或机制词相近就自行叠加、轮换、替代或按 mg 换算。请将全部实际药盒、处方和补充剂交由药师或开方团队逐项核对。", "en": "Medicines that also involve inflammation, joint pain, uric acid or cell processes cannot be self-combined, alternated, substituted or milligram-converted because their names, uses or mechanism terms seem similar. Have a pharmacist or prescribing team review every actual pack, prescription and supplement item by item." }, { "zh": "机制说明不能决定何时开始、持续多久、是否漏用补回、是否停用或怎样处理急性症状。任何现实使用问题必须回到准确产品的现行目标市场资料和专业人员。", "en": "A mechanism explanation cannot decide when to start, how long to continue, whether to make up a missed use, whether to stop or how to handle an acute symptom. Any real-use question must return to current target-market information for the exact product and a professional." } ], "source": { "id": "src_66091bc6932d4d52", "label": "DailyMed（NLM）：COLCRYS 秋水仙碱美国有日期历史公开标签（Clinical Pharmacology；Takeda；2025-07 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=56c130d1-7581-4152-99a2-0014ee9366c0", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "COLCRYS", "generic": "秋水仙碱", "dosageFormClass": "口服片：每片秋水仙碱 0.6 mg（历史标签的 30 片瓶装展示面）" }, "labelSource": { "id": "src_66091bc6932d4d52", "label": "DailyMed（NLM）：COLCRYS 秋水仙碱美国有日期历史公开标签（Takeda；2025-07 修订；产品记录列示 2026-04-30 营销结束）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=56c130d1-7581-4152-99a2-0014ee9366c0", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "productRoutes": [ { "source": { "id": "src_66091bc6932d4d52", "label": "DailyMed（NLM）：COLCRYS 秋水仙碱美国有日期历史公开标签（Takeda；2025-07 修订；产品记录列示 2026-04-30 营销结束）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=56c130d1-7581-4152-99a2-0014ee9366c0", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-23", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-23", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "DailyMed 的 COLCRYS 历史公开标签列示秋水仙碱口服片，每片 0.6 mg，并有一个 NDC 64764-119-07、30 片瓶装展示面。公开产品记录同时列示该美国记录的营销结束日期为 2026-04-30；因此本页只帮助读者核对历史产品身份和原始文件，不将其描述为当前在售、可购买或可替代产品，也不把毫克数、刻痕、相互作用或不良反应文字转成个人片数、开始、停用、联用或换药建议。", "history": "这份有日期的美国公开标签列示 Initial U.S. Approval: 1961，并在公开产品记录中列示 NDA 022352、美国营销起始日期 2009-09-01 与营销结束日期 2026-04-30。上述是所引历史记录的定位信息，不能替代任何市场的现行标签；同一通用名的其他品牌、胶囊、其他包装、其他强度或其他市场产品都需按准确包装和当地现行资料分别核对。", "sourceDocuments": [ { "id": "src_66091bc6932d4d52", "label": "DailyMed（NLM）：COLCRYS 秋水仙碱美国有日期历史公开标签（Takeda；2025-07 修订；产品记录列示 2026-04-30 营销结束）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=56c130d1-7581-4152-99a2-0014ee9366c0", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" } ], "applicationNumber": "NDA 022352（有日期历史公开产品记录）", "approvalTimeline": [ { "date": "1961", "title": { "zh": "历史标签所列美国初始批准年份", "en": "Initial U.S. approval year listed in the historical label" }, "detail": { "zh": "这份 COLCRYS 有日期历史公开标签列示 Initial U.S. Approval: 1961。它只定位所引美国历史档案，不建立其他市场的批准、供应、可售资格、原研/仿制关系或个人适用性。", "en": "This dated COLCRYS historical public label lists Initial U.S. Approval: 1961. It locates only the cited U.S. historical archive and does not establish approval, supply, sale eligibility, originator/generic relationship or individual suitability in another market." }, "source": { "id": "src_66091bc6932d4d52", "label": "DailyMed（NLM）：COLCRYS 秋水仙碱美国有日期历史公开标签（Takeda；2025-07 修订；产品记录列示 2026-04-30 营销结束）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=56c130d1-7581-4152-99a2-0014ee9366c0", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" } }, { "date": "2025-07", "title": { "zh": "有日期历史标签修订", "en": "Dated historical-label revision" }, "detail": { "zh": "所引 DailyMed 标签标示 2025-07 修订。这个日期只说明所引文件版本，不能代表当前标签、当前安全结论、库存、购买资格或其他市场状态。", "en": "The cited DailyMed label is marked revised July 2025. The date identifies only the cited document version; it does not represent current labeling, current safety conclusions, stock, purchase eligibility or another-market status." }, "source": { "id": "src_66091bc6932d4d52", "label": "DailyMed（NLM）：COLCRYS 秋水仙碱美国有日期历史公开标签（Takeda；2025-07 修订；产品记录列示 2026-04-30 营销结束）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=56c130d1-7581-4152-99a2-0014ee9366c0", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" } }, { "date": "2026-04-30", "title": { "zh": "历史产品记录列示美国营销结束日期", "en": "U.S. marketing-end date listed in historical product data" }, "detail": { "zh": "所引公开产品记录列示 2026-04-30 为美国营销结束日期。因此本页不把 COLCRYS 表述为当前在售、可购、可替代或仍在美国供应；任何现行产品问题须回到目标市场的现行官方资料和专业人员。", "en": "The cited public product data list 30 Apr 2026 as the U.S. marketing-end date. This page therefore does not describe COLCRYS as currently marketed, purchasable, interchangeable or still supplied in the United States; current-product questions require current target-market official material and a professional." }, "source": { "id": "src_66091bc6932d4d52", "label": "DailyMed（NLM）：COLCRYS 秋水仙碱美国有日期历史公开标签（Takeda；2025-07 修订；产品记录列示 2026-04-30 营销结束）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=56c130d1-7581-4152-99a2-0014ee9366c0", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "历史产品记录列示营销结束日期 2026-04-30", "en": "Historical product data list a marketing-end date of 30 Apr 2026" }, "detail": { "zh": "本页只保留 COLCRYS 0.6 mg、NDC 64764-119-07、30 片瓶装的历史标签身份和原始文件入口；不建立当前在售、库存、购买、换用或供应结论。", "en": "This page retains only the historical label identity and primary-document entry point for COLCRYS 0.6 mg, NDC 64764-119-07 and a 30-tablet bottle; it does not establish current marketing, stock, purchase, switching or supply." } }, { "market": { "zh": "中国大陆、欧盟、日本及其他市场", "en": "Mainland China, EU, Japan and other markets" }, "status": { "zh": "待逐项建立现行市场记录", "en": "Current market record not established" }, "detail": { "zh": "不从这份美国历史标签推定当地商品名、批准、包装、供应、可售资格、原研/仿制关系或可替代性；每个市场都须按当地现行监管资料单独核对。", "en": "No local trade name, approval, packaging, supply, sale eligibility, originator/generic relationship or interchangeability is inferred from this U.S. historical label; each market requires separate checking against current local regulatory material." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "COLCRYS 0.6 mg、NDC 和 30 片瓶装是否意味着可以自行开始、加减、掰开或换到其他秋水仙碱产品？", "en": "Do COLCRYS 0.6 mg, an NDC and a 30-tablet bottle mean a person can self-start, adjust, split or change to another colchicine product?" }, "answer": { "zh": "不能。这些文字只识别所引美国历史标签中的准确片剂和瓶装。共同通用名、相近毫克数、包装照片或刻痕均不建立自行开始、增加、重复、掰开、停用、联用、轮换或替换关系；请带现行药盒、处方和完整药单请药师或开方团队复核。", "en": "No. These details only identify the exact tablet and bottle in the cited U.S. historical label. A shared generic name, nearby milligram number, package photo or score does not establish self-initiation, increase, repetition, splitting, stopping, co-use, alternation or substitution; take the current pack, prescription and complete medicine list to a pharmacist or prescribing team." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "dosage-forms-are-part-of-medicine-identity", "how-to-read-a-drug-label" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/colcrys/", "en": "https://origindrug.com/en/drugs/colcrys/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "creon", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-23", "status": "published_traceable_archive" }, "names": { "brand": "CREON", "generic": "胰酶", "aliases": [ "CREON", "pancrelipase", "胰酶", "胰酶肠溶胶囊", "creon 10000", "creon 25000" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "消化系统", "sourceArchiveMarket": "美国：DailyMed 有日期公开处方药标签（页面 2024-02-28 更新；本档案分别建立五种准确延迟释放胶囊瓶装身份；不代表当前供应或可得性）。本页不从这一美国文件推定中国大陆、欧盟、日本或其他市场的商品名、批准、供应、可售资格或可替代性。", "dosageFormClass": "胰酶延迟释放口服胶囊：每粒以脂肪酶、蛋白酶及淀粉酶 USP 单位共同标示；本档案只建立五种准确瓶装身份，不以数字推定个人粒数、换算或疗程。", "dosageFormClassCode": "oral_modified_release", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "2009（DailyMed 标签所列美国初始批准年份）", "archiveSponsorText": "AbbVie Inc. / DailyMed（NLM）美国公开标签" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [ "pancrelipase bulk ingredient", "other pancreatic enzyme product", "其他胰酶制剂" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-creon-pancrelipase-delayed-release-capsule-3000-usp-lipase-70-bottle-ndc-0032120370", "marketCode": "US", "labelVersion": { "zh": "DailyMed 有日期美国公开标签（页面 2024-02-28 更新）；仅为所引标签的准确包装展示面，不代表当前供应或可得性", "en": "Dated U.S. DailyMed public label (page updated 28 Feb 2024); exact cited package panel only, not current supply or availability" }, "dosageForm": { "zh": "CREON 胰酶延迟释放口服胶囊", "en": "CREON pancrelipase delayed-release oral capsule" }, "route": { "zh": "口服（标签产品身份字段）", "en": "oral (label product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 0032-1203-70", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_capsule", "primaryDisplay": { "zh": "每粒：脂肪酶 3,000 USP 单位；蛋白酶 9,500 USP 单位；淀粉酶 15,000 USP 单位；70 粒瓶装", "en": "Per capsule: lipase 3,000 USP units; protease 9,500 USP units; amylase 15,000 USP units; 70-capsule bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=creon-pancrelipase-delayed--release-caps-04.jpg&setid=073201aa-556d-4a70-918e-84e9616fd88d&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "脂肪酶", "en": "lipase" }, "value": 3000, "unit": "USP units", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒标签标示的酶活性；不是个人粒数、每餐安排、换算、联用或换药指令", "en": "labelled enzyme activity per capsule; not an individual's capsule count, meal plan, conversion, co-use or switching instruction" } }, { "ingredient": { "zh": "蛋白酶", "en": "protease" }, "value": 9500, "unit": "USP units", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒标签标示的酶活性；须与脂肪酶和淀粉酶标示一起核对", "en": "labelled enzyme activity per capsule; check together with the lipase and amylase wording" } }, { "ingredient": { "zh": "淀粉酶", "en": "amylase" }, "value": 15000, "unit": "USP units", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒标签标示的酶活性；须与脂肪酶和蛋白酶标示一起核对", "en": "labelled enzyme activity per capsule; check together with the lipase and protease wording" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 70, "countUnit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-23", "currentLabelDisplayed": false, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 70, "unit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "physicalClues": { "color": { "zh": "白色不透明胶囊帽与白色不透明胶囊体", "en": "white opaque cap and white opaque body" }, "shape": { "zh": "两节胶囊；无刻痕", "en": "two-piece capsule; unscored" }, "imprint": "CREON 1203", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_c0b1683acb6c584e", "label": "DailyMed（NLM）：CREON 胰酶延迟释放口服胶囊美国公开标签（AbbVie；页面 2024-02-28 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=073201aa-556d-4a70-918e-84e9616fd88d", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-creon-pancrelipase-delayed-release-capsule-6000-usp-lipase-100-bottle-ndc-0032120601", "marketCode": "US", "labelVersion": { "zh": "DailyMed 有日期美国公开标签（页面 2024-02-28 更新）；仅为所引标签的准确包装展示面，不代表当前供应或可得性", "en": "Dated U.S. DailyMed public label (page updated 28 Feb 2024); exact cited package panel only, not current supply or availability" }, "dosageForm": { "zh": "CREON 胰酶延迟释放口服胶囊", "en": "CREON pancrelipase delayed-release oral capsule" }, "route": { "zh": "口服（标签产品身份字段）", "en": "oral (label product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 0032-1206-01", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_capsule", "primaryDisplay": { "zh": "每粒：脂肪酶 6,000 USP 单位；蛋白酶 19,000 USP 单位；淀粉酶 30,000 USP 单位；100 粒瓶装", "en": "Per capsule: lipase 6,000 USP units; protease 19,000 USP units; amylase 30,000 USP units; 100-capsule bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=creon-pancrelipase-delayed--release-caps-05.jpg&setid=073201aa-556d-4a70-918e-84e9616fd88d&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "脂肪酶", "en": "lipase" }, "value": 6000, "unit": "USP units", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒标签标示的酶活性；不是个人粒数、每餐安排、换算、联用或换药指令", "en": "labelled enzyme activity per capsule; not an individual's capsule count, meal plan, conversion, co-use or switching instruction" } }, { "ingredient": { "zh": "蛋白酶", "en": "protease" }, "value": 19000, "unit": "USP units", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒标签标示的酶活性；须与脂肪酶和淀粉酶标示一起核对", "en": "labelled enzyme activity per capsule; check together with the lipase and amylase wording" } }, { "ingredient": { "zh": "淀粉酶", "en": "amylase" }, "value": 30000, "unit": "USP units", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒标签标示的酶活性；须与脂肪酶和蛋白酶标示一起核对", "en": "labelled enzyme activity per capsule; check together with the lipase and protease wording" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-23", "currentLabelDisplayed": false, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "physicalClues": { "color": { "zh": "橙色不透明胶囊帽与蓝色不透明胶囊体", "en": "orange opaque cap and blue opaque body" }, "shape": { "zh": "两节胶囊；无刻痕", "en": "two-piece capsule; unscored" }, "imprint": "CREON 1206", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_c0b1683acb6c584e", "label": "DailyMed（NLM）：CREON 胰酶延迟释放口服胶囊美国公开标签（AbbVie；页面 2024-02-28 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=073201aa-556d-4a70-918e-84e9616fd88d", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-creon-pancrelipase-delayed-release-capsule-12000-usp-lipase-250-bottle-ndc-0032121207", "marketCode": "US", "labelVersion": { "zh": "DailyMed 有日期美国公开标签（页面 2024-02-28 更新）；仅为所引标签的准确包装展示面，不代表当前供应或可得性", "en": "Dated U.S. DailyMed public label (page updated 28 Feb 2024); exact cited package panel only, not current supply or availability" }, "dosageForm": { "zh": "CREON 胰酶延迟释放口服胶囊", "en": "CREON pancrelipase delayed-release oral capsule" }, "route": { "zh": "口服（标签产品身份字段）", "en": "oral (label product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 0032-1212-07", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_capsule", "primaryDisplay": { "zh": "每粒：脂肪酶 12,000 USP 单位；蛋白酶 38,000 USP 单位；淀粉酶 60,000 USP 单位；250 粒瓶装", "en": "Per capsule: lipase 12,000 USP units; protease 38,000 USP units; amylase 60,000 USP units; 250-capsule bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=creon-pancrelipase-delayed--release-caps-06.jpg&setid=073201aa-556d-4a70-918e-84e9616fd88d&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "脂肪酶", "en": "lipase" }, "value": 12000, "unit": "USP units", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒标签标示的酶活性；不是个人粒数、每餐安排、换算、联用或换药指令", "en": "labelled enzyme activity per capsule; not an individual's capsule count, meal plan, conversion, co-use or switching instruction" } }, { "ingredient": { "zh": "蛋白酶", "en": "protease" }, "value": 38000, "unit": "USP units", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒标签标示的酶活性；须与脂肪酶和淀粉酶标示一起核对", "en": "labelled enzyme activity per capsule; check together with the lipase and amylase wording" } }, { "ingredient": { "zh": "淀粉酶", "en": "amylase" }, "value": 60000, "unit": "USP units", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒标签标示的酶活性；须与脂肪酶和蛋白酶标示一起核对", "en": "labelled enzyme activity per capsule; check together with the lipase and protease wording" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 250, "countUnit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-23", "currentLabelDisplayed": false, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 250, "unit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "physicalClues": { "color": { "zh": "棕色不透明胶囊帽与无色透明胶囊体", "en": "brown opaque cap and colorless transparent body" }, "shape": { "zh": "两节胶囊；无刻痕", "en": "two-piece capsule; unscored" }, "imprint": "CREON 1212", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_c0b1683acb6c584e", "label": "DailyMed（NLM）：CREON 胰酶延迟释放口服胶囊美国公开标签（AbbVie；页面 2024-02-28 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=073201aa-556d-4a70-918e-84e9616fd88d", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-creon-pancrelipase-delayed-release-capsule-24000-usp-lipase-100-bottle-ndc-0032122401", "marketCode": "US", "labelVersion": { "zh": "DailyMed 有日期美国公开标签（页面 2024-02-28 更新）；仅为所引标签的准确包装展示面，不代表当前供应或可得性", "en": "Dated U.S. DailyMed public label (page updated 28 Feb 2024); exact cited package panel only, not current supply or availability" }, "dosageForm": { "zh": "CREON 胰酶延迟释放口服胶囊", "en": "CREON pancrelipase delayed-release oral capsule" }, "route": { "zh": "口服（标签产品身份字段）", "en": "oral (label product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 0032-1224-01", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_capsule", "primaryDisplay": { "zh": "每粒：脂肪酶 24,000 USP 单位；蛋白酶 76,000 USP 单位；淀粉酶 120,000 USP 单位；100 粒瓶装", "en": "Per capsule: lipase 24,000 USP units; protease 76,000 USP units; amylase 120,000 USP units; 100-capsule bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=creon-pancrelipase-delayed--release-caps-07.jpg&setid=073201aa-556d-4a70-918e-84e9616fd88d&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "脂肪酶", "en": "lipase" }, "value": 24000, "unit": "USP units", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒标签标示的酶活性；不是个人粒数、每餐安排、换算、联用或换药指令", "en": "labelled enzyme activity per capsule; not an individual's capsule count, meal plan, conversion, co-use or switching instruction" } }, { "ingredient": { "zh": "蛋白酶", "en": "protease" }, "value": 76000, "unit": "USP units", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒标签标示的酶活性；须与脂肪酶和淀粉酶标示一起核对", "en": "labelled enzyme activity per capsule; check together with the lipase and amylase wording" } }, { "ingredient": { "zh": "淀粉酶", "en": "amylase" }, "value": 120000, "unit": "USP units", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒标签标示的酶活性；须与脂肪酶和蛋白酶标示一起核对", "en": "labelled enzyme activity per capsule; check together with the lipase and protease wording" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-23", "currentLabelDisplayed": false, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "physicalClues": { "color": { "zh": "橙色不透明胶囊帽与无色透明胶囊体", "en": "orange opaque cap and colorless transparent body" }, "shape": { "zh": "两节胶囊；无刻痕", "en": "two-piece capsule; unscored" }, "imprint": "CREON 1224", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_c0b1683acb6c584e", "label": "DailyMed（NLM）：CREON 胰酶延迟释放口服胶囊美国公开标签（AbbVie；页面 2024-02-28 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=073201aa-556d-4a70-918e-84e9616fd88d", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-creon-pancrelipase-delayed-release-capsule-36000-usp-lipase-100-bottle-ndc-0032301613", "marketCode": "US", "labelVersion": { "zh": "DailyMed 有日期美国公开标签（页面 2024-02-28 更新）；仅为所引标签的准确包装展示面，不代表当前供应或可得性", "en": "Dated U.S. DailyMed public label (page updated 28 Feb 2024); exact cited package panel only, not current supply or availability" }, "dosageForm": { "zh": "CREON 胰酶延迟释放口服胶囊", "en": "CREON pancrelipase delayed-release oral capsule" }, "route": { "zh": "口服（标签产品身份字段）", "en": "oral (label product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 0032-3016-13", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_capsule", "primaryDisplay": { "zh": "每粒：脂肪酶 36,000 USP 单位；蛋白酶 114,000 USP 单位；淀粉酶 180,000 USP 单位；100 粒瓶装", "en": "Per capsule: lipase 36,000 USP units; protease 114,000 USP units; amylase 180,000 USP units; 100-capsule bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=creon-pancrelipase-delayed--release-caps-0a.jpg&setid=073201aa-556d-4a70-918e-84e9616fd88d&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "脂肪酶", "en": "lipase" }, "value": 36000, "unit": "USP units", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒标签标示的酶活性；不是个人粒数、每餐安排、换算、联用或换药指令", "en": "labelled enzyme activity per capsule; not an individual's capsule count, meal plan, conversion, co-use or switching instruction" } }, { "ingredient": { "zh": "蛋白酶", "en": "protease" }, "value": 114000, "unit": "USP units", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒标签标示的酶活性；须与脂肪酶和淀粉酶标示一起核对", "en": "labelled enzyme activity per capsule; check together with the lipase and amylase wording" } }, { "ingredient": { "zh": "淀粉酶", "en": "amylase" }, "value": 180000, "unit": "USP units", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒标签标示的酶活性；须与脂肪酶和蛋白酶标示一起核对", "en": "labelled enzyme activity per capsule; check together with the lipase and protease wording" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-23", "currentLabelDisplayed": false, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "physicalClues": { "color": { "zh": "蓝色不透明胶囊帽与无色透明胶囊体", "en": "blue opaque cap and colorless transparent body" }, "shape": { "zh": "两节胶囊；无刻痕", "en": "two-piece capsule; unscored" }, "imprint": "CREON 1236", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_c0b1683acb6c584e", "label": "DailyMed（NLM）：CREON 胰酶延迟释放口服胶囊美国公开标签（AbbVie；页面 2024-02-28 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=073201aa-556d-4a70-918e-84e9616fd88d", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-creon-pancrelipase-delayed-release-capsule-12000-usp-lipase-250-bottle-ndc-0032121207", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=creon-pancrelipase-delayed--release-caps-06.jpg&setid=073201aa-556d-4a70-918e-84e9616fd88d&type=img", "alt": "CREON 胰酶延迟释放胶囊：脂肪酶 12,000 USP 单位、NDC 0032-1212-07、250 粒瓶装在美国 DailyMed 公开标签中的展示面", "archiveMarket": "美国", "labelVersion": "DailyMed 有日期公开标签（页面 2024-02-28 更新）", "presentation": "CREON 胰酶延迟释放胶囊：每粒脂肪酶 12,000 USP 单位、蛋白酶 38,000 USP 单位、淀粉酶 60,000 USP 单位，NDC 0032-1212-07，250 粒瓶装展示面。", "notice": "此图只对应美国 DailyMed 有日期公开标签中的 CREON、胰酶延迟释放胶囊、每粒脂肪酶 12,000 USP 单位、蛋白酶 38,000 USP 单位、淀粉酶 60,000 USP 单位、NDC 0032-1212-07 与 250 粒瓶装。它只帮助核对品牌、通用名、三项酶活性单位、剂型、NDC、包装数量、外观线索与来源；不用于鉴定真伪，也不证明其他强度、其他包装、其他市场、原研身份、当前供应、可得性、可替代性或任何个人的粒数、用餐安排、转换、联用或换药方案。", "source": { "id": "src_c0b1683acb6c584e", "label": "DailyMed（NLM）：CREON 胰酶延迟释放口服胶囊美国公开标签（AbbVie；页面 2024-02-28 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=073201aa-556d-4a70-918e-84e9616fd88d", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "CREON 说明书放大阅读：单位、缓释颗粒和“能否打开胶囊”必须先分开看", "en": "CREON label reading: units, delayed-release pellets and whether a capsule can be opened must be read separately" }, "summary": { "zh": "本模块以 AbbVie 的 DailyMed 美国公开标签为阅读入口，帮助核对 CREON、胰酶、延迟释放胶囊、每粒脂肪酶 USP 单位与目标市场。它不提供个人粒数、每餐/加餐方案、加减量、同类替换或购买结论。", "en": "This module uses AbbVie's U.S. DailyMed public label to check CREON, pancrelipase, delayed-release capsules, lipase USP units per capsule and target market. It does not provide an individual's capsule count, meal/snack plan, dose adjustment, same-class substitution or purchase conclusion." }, "checks": [ { "zh": "先核对 CREON、胰酶、延迟释放胶囊和每粒脂肪酶 USP 单位。3,000、6,000、12,000、24,000、36,000 不是 mg，也不是可以靠数字自行把不同胶囊互换、拼凑或减少的规则；标签把用量与个人情况和饮食等因素一起处理。", "en": "First check CREON, pancrelipase, delayed-release capsule and lipase USP units per capsule. 3,000, 6,000, 12,000, 24,000 and 36,000 are not milligrams and are not a rule for self-exchanging, assembling or reducing different capsules; the label handles use together with individual factors and diet." }, { "zh": "“延迟释放”说明胶囊内有肠溶颗粒。标签中针对该准确产品的处理文字包括完整吞咽、不得压碎或咀嚼；对吞咽困难另有受限情形的文字。它不是任何胶囊都能掰半、研碎、咀嚼、把颗粒分成两次、保存混合物或用另一胰酶产品替代的授权。", "en": "“Delayed release” means the capsule contains enteric-coated pellets. The label's handling text for this exact product includes swallowing whole and not crushing or chewing, with separate limited wording for swallowing difficulty. It is not permission to split, crush, chew, divide pellets for later use, store a mixture or replace with another pancreatic enzyme product." }, { "zh": "标签明确提示不要把其他胰酶产品当作 CREON 的自行替代。家中同时有不同强度、旧药盒、其他胰酶、营养补充剂或多种慢病药时，请把每一盒实际包装、处方和完整药单交给药师或开方团队；不要按“都是胰酶”、颜色或单位数字自行合并、轮换或换算。", "en": "The label explicitly cautions against treating another pancreatic enzyme product as a self-substitute for CREON. With different strengths, older packs, another enzyme product, supplements or multiple chronic medicines at home, have a pharmacist or prescribing team review every actual pack, prescription and complete medicine list; do not self-combine, alternate or convert from “all are enzymes,” colour or unit numbers." }, { "zh": "持续或明显腹痛、腹胀、呕吐、皮疹/呼吸困难、口腔疼痛或其他急性严重不适，应使用当地紧急医疗或既有照护渠道；不要等待网页，也不要因担心症状自行停止、补用、改变胶囊内容物或更换产品。", "en": "With persistent or marked abdominal pain, bloating, vomiting, rash/breathing trouble, mouth pain or another acute serious concern, use local urgent or established care; do not wait for a webpage or self-stop, make up, alter capsule contents or change products because of a concern." } ], "source": { "id": "src_c0b1683acb6c584e", "label": "DailyMed（NLM）：CREON 胰酶延迟释放口服胶囊美国公开标签（AbbVie；页面 2024-02-28 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=073201aa-556d-4a70-918e-84e9616fd88d", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "胰酶怎样起作用：标签描述脂肪酶、蛋白酶和淀粉酶帮助分解食物成分", "en": "How pancrelipase works: the label describes lipase, protease and amylase helping digest food components" }, "summary": { "zh": "标签把胰酶描述为含脂肪酶、蛋白酶和淀粉酶的酶制剂，并说明这些酶在小肠近端参与食物脂肪、蛋白质和淀粉的分解。这个机制说明不决定任何个人是否需要此药、应使用多少、能否与其他产品同用或何时改用。", "en": "The label describes pancrelipase as an enzyme preparation containing lipase, protease and amylase, and says these enzymes participate in digesting dietary fats, proteins and starches in the proximal small intestine. This mechanism explanation does not decide whether an individual needs it, how much to use, whether it can be combined with another product or when to change." }, "checks": [ { "zh": "“帮助消化”不等于任何腹胀、腹泻、体重变化或饭后不适都可以自行用胰酶处理；这些症状可能有不同原因，网页不能诊断或替代评估。", "en": "“Helps digestion” does not mean every bloating, diarrhoea, weight change or post-meal concern can be self-treated with pancrelipase; such symptoms may have different causes, and a webpage cannot diagnose or replace assessment." }, { "zh": "脂肪酶 USP 单位描述的是标签中的酶活性标示，不等于毫克，也不能从另一种胰酶、另一强度、另一剂型或另一市场包装自行推算替换关系。", "en": "Lipase USP units describe labelled enzyme activity, not milligrams, and do not allow a self-derived substitution across another enzyme product, strength, form or market pack." }, { "zh": "延迟释放颗粒与酶活性相关的术语不能预测个人症状、营养状态或联用风险。出现严重不适或不确定如何使用时，应让药师或开方团队结合实际药盒、完整药单与现行标签核对。", "en": "Terms about delayed-release pellets and enzyme activity cannot predict an individual's symptoms, nutritional status or combination risk. With a serious concern or uncertainty about use, have a pharmacist or prescribing team review the actual pack, complete medicine list and current label." } ], "source": { "id": "src_c0b1683acb6c584e", "label": "DailyMed（NLM）：CREON 胰酶延迟释放口服胶囊美国公开标签（AbbVie；页面 2024-02-28 更新；Clinical Pharmacology）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=073201aa-556d-4a70-918e-84e9616fd88d", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "CREON", "generic": "胰酶", "dosageFormClass": "胰酶延迟释放口服胶囊：每粒以脂肪酶、蛋白酶及淀粉酶 USP 单位共同标示；本档案只建立五种准确瓶装身份，不以数字推定个人粒数、换算或疗程。" }, "labelSource": { "id": "src_c0b1683acb6c584e", "label": "DailyMed（NLM）：CREON 胰酶延迟释放口服胶囊美国公开标签（AbbVie；页面 2024-02-28 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=073201aa-556d-4a70-918e-84e9616fd88d", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "productRoutes": [ { "source": { "id": "src_c0b1683acb6c584e", "label": "DailyMed（NLM）：CREON 胰酶延迟释放口服胶囊美国公开标签（AbbVie；页面 2024-02-28 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=073201aa-556d-4a70-918e-84e9616fd88d", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-23", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-23", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "CREON 是胰酶延迟释放胶囊。标签上的 3,000、6,000、12,000、24,000、36,000 是每粒脂肪酶的 USP 单位，且同一粒还含蛋白酶和淀粉酶单位；本页把这些三项单位、NDC 与包装数量逐一对应到五个准确瓶装面板。它们不是网页可以换算成“吃几粒”的答案。不同强度、每餐/加餐安排、体重、饮食与疾病情况需要由开方团队逐项确认。", "history": "所引 DailyMed 美国公开标签列示 Initial U.S. Approval: 2009、AbbVie Inc. 为包装方，并显示页面更新日期为 2024-02-28。本页仅保留其中五个准确延迟释放胶囊瓶装面板；每个面板都须把三项酶活性单位、NDC、粒数和胶囊文字一同核对。该来源还把胶囊定义为延迟释放颗粒制剂，并写有与完整吞咽、不得压碎或咀嚼及特定处理相关的产品文字。来源日期和历史节点只定位所引文件，不能替代手中实际产品的现行说明书、处方判断或目标市场记录。", "sourceDocuments": [ { "id": "src_c0b1683acb6c584e", "label": "DailyMed（NLM）：CREON 胰酶延迟释放口服胶囊美国公开标签（AbbVie；页面 2024-02-28 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=073201aa-556d-4a70-918e-84e9616fd88d", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" } ], "applicationNumber": "DailyMed 公开标签所列 Biologic Licensing Application 记录（本档案不另行断言具体申请号）", "approvalTimeline": [ { "date": "2009", "title": { "zh": "FDA 标签所列美国初始批准年份", "en": "Initial U.S. approval year listed in the FDA label" }, "detail": { "zh": "本页链接的 FDA 标签档案列示 Initial U.S. Approval: 2009。该历史定位不等同于当前批准、可得性、持有人或其他市场状态。", "en": "The FDA label archive linked here lists Initial U.S. Approval: 2009. This historical locator is not a conclusion about current approval, availability, holder or another market." }, "source": { "id": "src_c0b1683acb6c584e", "label": "DailyMed: CREON pancrelipase delayed-release capsule public label", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=073201aa-556d-4a70-918e-84e9616fd88d", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" } }, { "date": "2024-02-28", "title": { "zh": "FDA 标签档案版本", "en": "FDA label archive version" }, "detail": { "zh": "本页链接 2024-02-28 的 FDA 标签档案作为可复核阅读入口。现行标签、规格、适应症和安全信息必须另行以目标市场当前文件核对。", "en": "This page links the 2024-02-28 FDA label archive as a traceable reading entry point. Current labeling, strength, indication and safety information require separate verification against the target market’s current document." }, "source": { "id": "src_c0b1683acb6c584e", "label": "DailyMed: CREON pancrelipase delayed-release capsule public label", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=073201aa-556d-4a70-918e-84e9616fd88d", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "已链接公开标签档案", "en": "Public label archive linked" }, "detail": { "zh": "仅对应本页所列 FDA 文件。", "en": "Only the FDA document listed on this page is linked." } }, { "market": { "zh": "中国大陆、欧盟、日本", "en": "Mainland China, EU, Japan" }, "status": { "zh": "待逐项建立市场记录", "en": "Market record not established" }, "detail": { "zh": "不从美国标签档案推定当地批准、持有人、规格、供应或可售资格。", "en": "No local approval, holder, strength, supply or sale-eligibility conclusion is inferred from the U.S. label archive." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "标签档案能代表现在的产品信息吗？", "en": "Does a label archive represent current product information?" }, "answer": { "zh": "不能自动代表。档案用于定位来源；需要以目标市场的现行官方标签逐项复核。", "en": "Not automatically. The archive locates a source; each point needs verification against the target market’s current official label." } }, { "question": { "zh": "为什么这里不展示价格或原研/仿制结论？", "en": "Why are price and originator/generic conclusions not shown?" }, "answer": { "zh": "这些结论需要产品、剂型、规格、包装、市场、日期和原始记录分别齐全并经人工审核；单一标签文件不足以支持。", "en": "Those conclusions require separately complete and human-reviewed product, dosage-form, strength, pack, market, date and primary-record fields; one label file is insufficient." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "how-to-read-a-drug-label", "regulatory-sources-first" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/creon/", "en": "https://origindrug.com/en/drugs/creon/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "nexium", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-20", "status": "published_traceable_archive" }, "names": { "brand": "Nexium", "generic": "埃索美拉唑", "aliases": [ "esomeprazole", "esomeprazole magnesium", "艾司奥美拉唑", "艾司奥美拉唑镁", "艾司奥美拉唑镁肠溶片", "耐信" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": { "value": "耐信®", "status": "discovery_cue_requires_target_market_verification", "source": { "id": "src_bfcd3ef4b4a99670", "label": "青岛市人民政府：2025 年医院药品记录中的耐信／艾司奥美拉唑镁肠溶片记录", "url": "https://www.qingdao.gov.cn/ywdt/zwzl/ggqsydwgk/wsjk_208049/yy/qdsdsyy/zzbs/jg/202506/t20250604_9610087.shtml", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "government_medicine_listing", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-12", "reviewedAt": "2026-09-12" } } }, "identity": { "therapeuticArea": "消化系统", "sourceArchiveMarket": "美国当前公开处方药标签", "dosageFormClass": "延迟释放胶囊；延迟释放口服混悬剂（DailyMed 2025-12 标签所列）", "dosageFormClassCode": "oral_modified_release", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "1989（美国标签中关于 omeprazole 的历史表述）", "archiveSponsorText": "AstraZeneca Pharmaceuticals LP / DailyMed（NLM）公开标签" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-nexium-delayed-release-capsule-20mg-ndc-0186-5020-31", "marketCode": "US", "labelVersion": { "zh": "DailyMed，2025-12-19 更新", "en": "DailyMed, updated 19 Dec 2025" }, "dosageForm": { "zh": "NEXIUM 埃索美拉唑镁延迟释放口服胶囊", "en": "NEXIUM esomeprazole magnesium delayed-release oral capsule" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 0186-5020-31", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_capsule", "primaryDisplay": { "zh": "每粒 20 mg；30 粒瓶装", "en": "20 mg per capsule; 30-capsule bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=image-06.jpg&setid=f4853677-1622-4037-688b-fdf533a11d96", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "埃索美拉唑", "en": "esomeprazole" }, "value": 20, "unit": "mg", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒延迟释放胶囊标示量；不是个人胶囊数、疗程或换药规则", "en": "labelled amount per delayed-release capsule; not an individual's capsule count, duration or switching rule" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "30 粒瓶装", "en": "30-capsule bottle" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-20", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 30, "unit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "physicalClues": { "color": { "zh": "紫水晶色不透明硬明胶胶囊；黄色条纹与文字", "en": "amethyst opaque hard-gelatin capsule with yellow bars and lettering" }, "shape": { "zh": "延迟释放胶囊", "en": "delayed-release capsule" }, "imprint": "NEXIUM 20 mg", "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_f433ccf7399e9a43", "label": "DailyMed（NLM）：NEXIUM 埃索美拉唑镁当前美国公开标签（AstraZeneca；2025-12-19 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=f4853677-1622-4037-688b-fdf533a11d96", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-nexium-delayed-release-capsule-20mg-ndc-0186-5020-31", "status": "source_linked_current_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=image-06.jpg&setid=f4853677-1622-4037-688b-fdf533a11d96", "alt": "NEXIUM 20 mg 埃索美拉唑镁延迟释放胶囊在美国 DailyMed 公开标签中的 AstraZeneca 30 粒装瓶身标签图", "archiveMarket": "美国", "labelVersion": "DailyMed 公开标签（2025-12 更新）", "presentation": "NEXIUM 20 mg、30 粒延迟释放胶囊瓶身标签图（DailyMed 公开标签所列；AstraZeneca 标签图）。", "notice": "此为美国 DailyMed 公开标签中明确对应 NEXIUM 20 mg、30 粒延迟释放胶囊的 AstraZeneca 标签图，只帮助核对品牌、通用名、标示强度、延迟释放胶囊、包装数量和来源；不用于鉴定真伪，也不证明 40 mg、口服混悬剂、其他包装、其他市场标签、当前包装、原研身份、目标市场批准或可售资格。", "source": { "id": "src_f433ccf7399e9a43", "label": "DailyMed（NLM）：NEXIUM 公开标签（AstraZeneca，2025-12 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=f4853677-1622-4037-688b-fdf533a11d96", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "NEXIUM 说明书放大阅读：延迟释放胶囊与口服混悬剂不是只看“胃药”三个字", "en": "NEXIUM label reading: delayed-release capsules and oral suspension are more than a generic “stomach medicine”" }, "summary": { "zh": "本模块以 DailyMed 2025-12 美国公开标签为阅读入口，帮助核对 NEXIUM、埃索美拉唑镁、延迟释放胶囊或延迟释放口服混悬剂、每一单位标示强度和目标市场；它不决定个人服用数量、打开/混合方式、疗程或与另一种抑酸药的转换。", "en": "This module uses the Dec 2025 U.S. DailyMed public label as a reading entry point. It helps check NEXIUM, esomeprazole magnesium, delayed-release capsule or delayed-release oral suspension, labelled strength per unit and target market; it does not decide an individual's amount, opening/mixing method, duration or conversion to another acid-suppressing medicine." }, "checks": [ { "zh": "把商品名、通用名、延迟释放剂型、准确规格和目标市场一起核对。胶囊与口服混悬剂的颗粒、浓度、量具和操作要求不应从“都叫埃索美拉唑”或相同 mg 数字自行推断或互换。", "en": "Check brand, generic name, delayed-release form, exact strength and target market together. Capsule and oral-suspension granules, concentration, measuring device and handling requirements must not be inferred or exchanged simply because both say esomeprazole or show the same mg number." }, { "zh": "“延迟释放”属于产品身份的一部分。是否能打开、与何种食物或液体混合、能否咀嚼、研碎、分开，必须回到准确产品的现行标签和药师指导；不要把另一盒普通片、其他胶囊或过往经验套用过来。", "en": "“Delayed release” is part of product identity. Opening, mixing with a food or liquid, chewing, crushing or dividing must return to the current label and pharmacist guidance for the exact product; do not transfer experience from another ordinary tablet, capsule or previous pack." }, { "zh": "NEXIUM、PRILOSEC、PREVACID 等名称或用途相近的产品不因都与胃酸有关而可自行叠加、轮换或替代。完整药单、症状变化、既往疾病和实际包装需要由药师或开方团队逐项复核。", "en": "Products such as NEXIUM, PRILOSEC and PREVACID are not self-combinable, alternatable or substitutable merely because their names or purposes relate to gastric acid. A pharmacist or prescribing team needs to review the complete medicine list, symptom changes, prior conditions and actual packages item by item." }, { "zh": "长期或反复不适、吞咽困难、呕血/黑便等警示症状，或不确定具体制剂怎样使用时，应及时使用当地医疗支持渠道；网页不能替代病因评估或处方调整。", "en": "With persistent or recurrent symptoms, difficulty swallowing, vomiting blood/black stools or uncertainty about how to use an exact formulation, use timely local medical-support pathways; a webpage cannot replace cause assessment or prescription adjustment." } ], "source": { "id": "src_f433ccf7399e9a43", "label": "DailyMed（NLM）：NEXIUM 埃索美拉唑镁当前美国公开标签（AstraZeneca；2025-12-19 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=f4853677-1622-4037-688b-fdf533a11d96", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "埃索美拉唑怎样起作用：它抑制胃壁细胞的质子泵", "en": "How esomeprazole works: it inhibits the gastric parietal-cell proton pump" }, "summary": { "zh": "FDA 标签将埃索美拉唑描述为质子泵抑制剂，并说明其通过特异性抑制胃壁细胞分泌表面的 H+/K+-ATPase 抑制胃酸分泌。它解释的是作用路径，不说明个人应服多少、服多久、是否与另一种抑酸产品叠加或何时换药。", "en": "The FDA label describes esomeprazole as a proton-pump inhibitor that suppresses gastric-acid secretion through specific inhibition of the H+/K+-ATPase at the secretory surface of the gastric parietal cell. This explains an action pathway; it does not say how much or how long an individual should use, whether to add another acid-suppressing product, or when to switch." }, "checks": [ { "zh": "共同作用于质子泵，不使埃索美拉唑、奥美拉唑、兰索拉唑或其他抑酸产品可自行叠加、轮换或等量换算。商品名、剂型、标示强度、用途、完整药单与现行处方都需逐项核对。", "en": "A shared proton-pump pathway does not make esomeprazole, omeprazole, lansoprazole or another acid-suppressing product self-combinable, alternatable or dose-convertible. Brand, dosage form, labelled strength, use context, complete medicine list and current prescription all need item-by-item review." }, { "zh": "机制不能判断烧心、腹痛、咳嗽、吞咽问题或其他症状的原因，也不能决定是否继续、加量或改成另一种药。症状变化应按现行标签、实际病情和专业评估处理。", "en": "Mechanism cannot identify the cause of heartburn, abdominal pain, cough, swallowing trouble or another symptom, nor decide continuation, increase or a change to another medicine. Symptom changes need the current label, real clinical context and professional assessment." }, { "zh": "延迟释放胶囊或口服混悬剂的操作问题属于制剂信息，不会由同一机制自动给出答案。请以准确包装的说明书和药师指导核对。", "en": "Handling questions for a delayed-release capsule or oral suspension are formulation information; a shared mechanism does not answer them automatically. Check the label for the exact package and pharmacist guidance." } ], "source": { "id": "src_f433ccf7399e9a43", "label": "DailyMed（NLM）：NEXIUM 埃索美拉唑镁当前美国公开标签（临床药理；AstraZeneca；2025-12-19 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=f4853677-1622-4037-688b-fdf533a11d96", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "Nexium", "generic": "埃索美拉唑", "dosageFormClass": "延迟释放胶囊；延迟释放口服混悬剂（DailyMed 2025-12 标签所列）" }, "labelSource": { "id": "src_f433ccf7399e9a43", "label": "DailyMed（NLM）：NEXIUM 埃索美拉唑镁当前美国公开标签（AstraZeneca；2025-12-19 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=f4853677-1622-4037-688b-fdf533a11d96", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "productRoutes": [ { "source": { "id": "src_f433ccf7399e9a43", "label": "DailyMed（NLM）：NEXIUM 埃索美拉唑镁当前美国公开标签（AstraZeneca；2025-12-19 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=f4853677-1622-4037-688b-fdf533a11d96", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_095bc51f77a8c72b", "label": "FDA：NEXIUM 2022 美国标签档案（NDA 021153 / 021957 / 022101）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021153s059%2C021957s026%2C022101s023lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "DailyMed 的 AstraZeneca NEXIUM（esomeprazole magnesium）2025-12 美国公开标签涵盖延迟释放胶囊与延迟释放口服混悬剂。本页的精确包装记录只对应 20 mg、30 粒延迟释放胶囊瓶装（NDC 0186-5020-31）；不把它延伸为 40 mg、口服混悬剂、其他包装、其他市场、供应、价格或销售资格结论。", "history": "该标签中的“Initial U.S. Approval: 1989”明确附带 omeprazole 的限定，不能被简化为对任一市场或包装的原研关系结论。不同剂型、规格、市场与标签版本须分别查验。", "sourceDocuments": [ { "id": "src_f433ccf7399e9a43", "label": "DailyMed（NLM）：NEXIUM 埃索美拉唑镁当前美国公开标签（AstraZeneca；2025-12-19 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=f4853677-1622-4037-688b-fdf533a11d96", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_095bc51f77a8c72b", "label": "FDA：NEXIUM 2022 美国标签档案（NDA 021153 / 021957 / 022101）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021153s059%2C021957s026%2C022101s023lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_5ed30b676fbb9773", "label": "FDA Drugs@FDA 官方检索入口", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_lookup_entry", "documentKind": "regulatory_lookup", "market": "US", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } ], "applicationNumber": "NDA 021153 / 021957 / 022101", "approvalTimeline": [ { "date": "1989", "title": { "zh": "FDA 标签所列美国初始批准年份", "en": "Initial U.S. approval year listed in the FDA label" }, "detail": { "zh": "本页链接的 FDA 标签档案列示美国初始批准年份为 1989，并明确该表述指奥美拉唑。该历史定位不等同于当前批准、可得性、持有人或其他市场状态。", "en": "The FDA label archive linked here lists Initial U.S. Approval: 1989, and expressly identifies that statement as referring to omeprazole. This historical locator is not a conclusion about current approval, availability, holder or another market." }, "source": { "id": "src_095bc51f77a8c72b", "label": "FDA: NEXIUM label archive", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021153s059%2C021957s026%2C022101s023lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, { "date": "2022", "title": { "zh": "FDA 标签档案版本", "en": "FDA label archive version" }, "detail": { "zh": "本页链接 2022 的 FDA 标签档案作为可复核阅读入口。现行标签、规格、适应症和安全信息必须另行以目标市场当前文件核对。", "en": "This page links the 2022 FDA label archive as a traceable reading entry point. Current labeling, strength, indication and safety information require separate verification against the target market’s current document." }, "source": { "id": "src_095bc51f77a8c72b", "label": "FDA: NEXIUM label archive", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021153s059%2C021957s026%2C022101s023lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "已链接公开标签档案", "en": "Public label archive linked" }, "detail": { "zh": "仅对应本页所列 FDA 文件。", "en": "Only the FDA document listed on this page is linked." } }, { "market": { "zh": "中国大陆、欧盟、日本", "en": "Mainland China, EU, Japan" }, "status": { "zh": "待逐项建立市场记录", "en": "Market record not established" }, "detail": { "zh": "不从美国标签档案推定当地批准、持有人、规格、供应或可售资格。", "en": "No local approval, holder, strength, supply or sale-eligibility conclusion is inferred from the U.S. label archive." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "标签档案能代表现在的产品信息吗？", "en": "Does a label archive represent current product information?" }, "answer": { "zh": "不能自动代表。档案用于定位来源；需要以目标市场的现行官方标签逐项复核。", "en": "Not automatically. The archive locates a source; each point needs verification against the target market’s current official label." } }, { "question": { "zh": "为什么这里不展示价格或原研/仿制结论？", "en": "Why are price and originator/generic conclusions not shown?" }, "answer": { "zh": "这些结论需要产品、剂型、规格、包装、市场、日期和原始记录分别齐全并经人工审核；单一标签文件不足以支持。", "en": "Those conclusions require separately complete and human-reviewed product, dosage-form, strength, pack, market, date and primary-record fields; one label file is insufficient." } } ], "relatedMedicineChecks": [ { "target": { "id": "clopidogrel-plavix", "brand": "Plavix", "generic": "氯吡格雷", "canonicalUrls": { "zh": "https://origindrug.com/drugs/clopidogrel-plavix/", "en": "https://origindrug.com/en/drugs/clopidogrel-plavix/" } }, "title": { "zh": "与 PLAVIX／氯吡格雷同在药单上时：先做完整清单核对", "en": "When PLAVIX / clopidogrel is on the same list: review the complete list first" }, "summary": { "zh": "PLAVIX 的美国公开标签将奥美拉唑或埃索美拉唑列为需要核对的联用线索。本卡片只提示把所有实际药盒、非处方药和补充剂交给药师或开方团队复核；它不判断能否同服，也不建议自行停用、错开时间、替换或调整任何一种药。", "en": "The U.S. PLAVIX public label names omeprazole or esomeprazole as co-medication cues that need review. This card only signals that every actual pack, OTC product and supplement should be reviewed by a pharmacist or prescriber; it does not decide co-use or advise self-stopping, time-separation, replacement or adjustment of either medicine." }, "source": { "id": "src_3e070dd8ebe91314", "label": "DailyMed（NLM）：PLAVIX 氯吡格雷当前美国公开标签（Sanofi-Aventis；SPL v5，2025-06-11 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=de8b0b67-eb25-4684-83b5-7ad785314227", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "scope": "review_complete_medicine_list_no_self_directed_change" } ], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "how-to-read-a-drug-label", "regulatory-sources-first" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/nexium/", "en": "https://origindrug.com/en/drugs/nexium/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "prevacid", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-22", "status": "published_traceable_archive" }, "names": { "brand": "Prevacid", "generic": "兰索拉唑", "aliases": [ "PREVACID", "PREVACID SoluTab", "lansoprazole", "兰索拉唑" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "消化系统", "sourceArchiveMarket": "美国 DailyMed 当前公开标签（2025-03 修订）；此页仅展示该标签明确对应的 30 mg 胶囊及 15 mg、30 mg SoluTab 包装面板，不据此建立目标市场可得性结论。", "dosageFormClass": "30 mg 延迟释放胶囊；15 mg、30 mg 延迟释放口崩片（DailyMed 2025-03 公开标签所列）", "dosageFormClassCode": "oral_modified_release", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "1995（DailyMed 2025-03 美国公开标签所列初始批准）", "archiveSponsorText": "Takeda / DailyMed 公开监管标签档案" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [ "PREVACID 15 mg delayed-release capsules", "PREVACID 15 mg capsules" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-prevacid-lansoprazole-delayed-release-capsule-30mg-100-bottle-ndc-64764-046-13", "marketCode": "US", "labelVersion": { "zh": "2025-03 修订", "en": "revised Mar 2025" }, "dosageForm": { "zh": "兰索拉唑延迟释放胶囊", "en": "lansoprazole delayed-release capsule" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 64764-046-13", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_capsule", "primaryDisplay": { "zh": "30 mg／粒；100 粒瓶装", "en": "30 mg per capsule; 100-capsule bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=prevacid-04.jpg&setid=71ba78cb-7e46-43eb-9425-fa130f537f84&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "兰索拉唑", "en": "lansoprazole" }, "value": 30, "unit": "mg", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒标签标示量；不是个人服用数量、调整或换算指令", "en": "labelled amount per capsule; not an individual amount, adjustment or conversion instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-22", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "physicalClues": { "color": { "zh": "不透明粉色与黑色", "en": "opaque pink and black" }, "shape": { "zh": "延迟释放胶囊", "en": "delayed-release capsule" }, "imprint": "TAP / PREVACID 30", "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_fe786172b22ae19e", "label": "DailyMed（NLM）：PREVACID / PREVACID SoluTab 当前美国公开标签（Takeda；2025-03 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=71ba78cb-7e46-43eb-9425-fa130f537f84", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-prevacid-solutab-lansoprazole-delayed-release-odt-15mg-100-carton-ndc-64764-543-11", "marketCode": "US", "labelVersion": { "zh": "2025-03 修订", "en": "revised Mar 2025" }, "dosageForm": { "zh": "PREVACID SoluTab 兰索拉唑延迟释放口崩片", "en": "PREVACID SoluTab lansoprazole delayed-release orally disintegrating tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 64764-543-11", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "15 mg／片；100 片单剂量包装纸盒（10 包 × 每包 10 片）", "en": "15 mg per tablet; 100-tablet unit-dose carton (10 packs of 10 tablets)" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=prevacid-05.jpg&setid=71ba78cb-7e46-43eb-9425-fa130f537f84&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "兰索拉唑", "en": "lansoprazole" }, "value": 15, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人服用数量、调整或换算指令", "en": "labelled amount per tablet; not an individual amount, adjustment or conversion instruction" } } ], "concentration": null, "container": { "typeCode": "unit_dose_carton", "typeLabel": { "zh": "单剂量包装纸盒", "en": "unit-dose package carton" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "片/盒", "en": "tablets per carton" }, "unitsPerContainer": { "count": 10, "unit": { "zh": "片/单剂量包装", "en": "tablets per unit-dose pack" } } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-22", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "片/盒", "en": "tablets per carton" } }, "physicalClues": { "color": { "zh": "白色至淡黄色白色，带橙色至深棕色斑点", "en": "white to yellowish white with orange to dark-brown speckles" }, "shape": { "zh": "圆形无包衣口崩片", "en": "round uncoated orally disintegrating tablet" }, "imprint": "15", "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_fe786172b22ae19e", "label": "DailyMed（NLM）：PREVACID / PREVACID SoluTab 当前美国公开标签（Takeda；2025-03 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=71ba78cb-7e46-43eb-9425-fa130f537f84", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-prevacid-solutab-lansoprazole-delayed-release-odt-30mg-100-carton-ndc-64764-544-11", "marketCode": "US", "labelVersion": { "zh": "2025-03 修订", "en": "revised Mar 2025" }, "dosageForm": { "zh": "PREVACID SoluTab 兰索拉唑延迟释放口崩片", "en": "PREVACID SoluTab lansoprazole delayed-release orally disintegrating tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 64764-544-11", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "30 mg／片；100 片单剂量包装纸盒（10 包 × 每包 10 片）", "en": "30 mg per tablet; 100-tablet unit-dose carton (10 packs of 10 tablets)" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=prevacid-06.jpg&setid=71ba78cb-7e46-43eb-9425-fa130f537f84&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "兰索拉唑", "en": "lansoprazole" }, "value": 30, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人服用数量、调整或换算指令", "en": "labelled amount per tablet; not an individual amount, adjustment or conversion instruction" } } ], "concentration": null, "container": { "typeCode": "unit_dose_carton", "typeLabel": { "zh": "单剂量包装纸盒", "en": "unit-dose package carton" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "片/盒", "en": "tablets per carton" }, "unitsPerContainer": { "count": 10, "unit": { "zh": "片/单剂量包装", "en": "tablets per unit-dose pack" } } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-22", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "片/盒", "en": "tablets per carton" } }, "physicalClues": { "color": { "zh": "白色至淡黄色白色，带橙色至深棕色斑点", "en": "white to yellowish white with orange to dark-brown speckles" }, "shape": { "zh": "圆形无包衣口崩片", "en": "round uncoated orally disintegrating tablet" }, "imprint": "30", "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_fe786172b22ae19e", "label": "DailyMed（NLM）：PREVACID / PREVACID SoluTab 当前美国公开标签（Takeda；2025-03 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=71ba78cb-7e46-43eb-9425-fa130f537f84", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": null, "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=prevacid-04.jpg&setid=71ba78cb-7e46-43eb-9425-fa130f537f84&type=img", "alt": "PREVACID 30 mg 兰索拉唑延迟释放胶囊在美国 DailyMed 公开标签中的 Takeda 100 粒瓶装标签图", "archiveMarket": "美国", "labelVersion": "DailyMed 公开标签（Takeda，2025-07 更新；处方信息 2025-03 修订）", "presentation": "PREVACID 30 mg、100 粒延迟释放胶囊瓶装标签图（DailyMed 公开标签所列；Takeda 标签图）。", "notice": "此为美国 DailyMed 公开标签中明确对应 PREVACID 30 mg、100 粒延迟释放胶囊的 Takeda 标签图，只帮助核对品牌、通用名、标示强度、延迟释放胶囊、包装数量和来源；不用于鉴定真伪，也不证明 PREVACID SoluTab、15 mg 口崩片、其他包装、其他市场标签、当前包装、原研身份、目标市场批准或可售资格。", "source": { "id": "src_fe786172b22ae19e", "label": "DailyMed（NLM）：PREVACID / PREVACID SoluTab 当前美国公开标签（Takeda，2025-03 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=71ba78cb-7e46-43eb-9425-fa130f537f84", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "PREVACID 说明书放大阅读：延迟释放胶囊与口崩片的产品身份要分开看", "en": "PREVACID label reading: delayed-release capsules and orally disintegrating tablets need separate product identity" }, "summary": { "zh": "本模块以 Takeda 的 DailyMed 美国公开标签为阅读入口（页面 2025-07 更新；处方信息 2025-03 修订），帮助分开核对 PREVACID 30 mg 延迟释放胶囊，以及 PREVACID SoluTab 15 mg/30 mg 延迟释放口崩片；它不提供个人服用数量、疗程、停药或换药方案。", "en": "This module uses Takeda's U.S. DailyMed public label as a reading entry point (page updated Jul 2025; prescribing information revised Mar 2025). It separates PREVACID 30 mg delayed-release capsules from PREVACID SoluTab 15 mg/30 mg delayed-release orally disintegrating tablets; it does not provide an individual's amount, duration, stopping or switching plan." }, "checks": [ { "zh": "先把商品名、兰索拉唑、剂型、标示强度和目标市场一起核对。30 mg PREVACID 胶囊与 15 mg/30 mg PREVACID SoluTab 是同一公开标签中分别列出的不同制剂；相同通用名或相近 mg 不能自动等同、互换或用来推算“该吃几颗”。", "en": "Check brand, lansoprazole, dosage form, labelled strength and target market together. The 30 mg PREVACID capsule and 15 mg/30 mg PREVACID SoluTab are separately listed dosage forms in the same public label; a shared generic name or nearby mg number does not make them automatically equivalent, interchangeable or a way to calculate “how many to take.”" }, { "zh": "这份准确美国标签写明：胶囊应整粒吞服、不要咀嚼；但对吞咽困难者，它另列了“打开胶囊后按标签指定的软食或液体给药”的具体方式。这个产品特定例外不等于任何延迟释放胶囊、任何包装或任何市场都可以打开、掰半、研碎或混入食物。", "en": "This exact U.S. label says to swallow the capsule whole and not chew it; for people who have difficulty swallowing, it separately lists specific labelled soft-food or liquid administration after opening the capsule. That product-specific exception does not mean every delayed-release capsule, pack or market may be opened, split, crushed or mixed with food." }, { "zh": "对 PREVACID SoluTab，标签写明可在舌上崩解后吞下微粒，但不要咀嚼微粒；它也列有针对特定人群和器械的给药步骤。不要把“口崩”理解成可咀嚼、研碎、分半，或套用到普通片剂、其他口崩片和其他兰索拉唑产品。", "en": "For PREVACID SoluTab, the label says the tablet may disintegrate on the tongue and the microgranules are swallowed without chewing; it also lists administration steps for specific people and devices. Do not read “orally disintegrating” as permission to chew, crush or split it, or as a rule for ordinary tablets, other orally disintegrating tablets or other lansoprazole products." }, { "zh": "不要因都被称为抑酸药，就把 PREVACID 与 NEXIUM、PRILOSEC、非处方胃药或其他处方药自行并用、轮换或换算。用途相似只能提示需要核对，不能构成个人用药结论。", "en": "Do not self-combine, alternate or convert PREVACID with NEXIUM, PRILOSEC, OTC stomach products or another prescription merely because all are called acid-suppressing medicines. A similar purpose only signals a need to review; it cannot establish an individual medicine conclusion." }, { "zh": "出现严重或持续不适、对吞咽或剂型操作不确定，或正在使用多种药物时，请带完整药单和实际包装联系专业人员；本页不判断继续、暂停或如何调整。", "en": "With severe or persistent symptoms, uncertainty about swallowing or formulation handling, or multiple medicines in use, bring the complete list and actual package to a professional; this page does not decide continuation, pause or adjustment." } ], "source": { "id": "src_fe786172b22ae19e", "label": "DailyMed（NLM）：PREVACID / PREVACID SoluTab 当前美国公开标签（Takeda；页面 2025-07 更新，处方信息 2025-03 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=71ba78cb-7e46-43eb-9425-fa130f537f84", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "兰索拉唑怎样起作用：它抑制胃壁细胞的质子泵", "en": "How lansoprazole works: it inhibits the gastric parietal-cell proton pump" }, "summary": { "zh": "DailyMed 的 Takeda 标签将兰索拉唑描述为质子泵抑制剂，说明其在胃壁细胞酸性环境中转化为活性形式并抑制 H+/K+-ATPase。它仅用于解释药理路径，不给出个人使用时机、强度、疗程或与其他抑酸药的转换结论。", "en": "Takeda's DailyMed label describes lansoprazole as a proton-pump inhibitor that is converted to an active form in the acidic environment of the parietal cell and inhibits H+/K+-ATPase. This only explains a pharmacologic pathway; it does not provide an individual timing, strength, duration or conversion conclusion with another acid-suppressing medicine." }, "checks": [ { "zh": "与埃索美拉唑或奥美拉唑同属质子泵抑制剂，并不证明可以同日叠加、隔日轮换、互相代替或按相同 mg 使用。每个产品的剂型、强度、用途、市场和完整药单必须由专业人员核对。", "en": "Sharing the proton-pump-inhibitor class with esomeprazole or omeprazole does not prove that medicines can be added on the same day, alternated on different days, substituted or used at the same mg. Dosage form, strength, use, market and complete medicine list for every product need professional review." }, { "zh": "机制不回答 SoluTab、胶囊或其他口服产品能否打开、咀嚼、研碎、分片或混合，也不替代准确产品的现行标签。", "en": "Mechanism does not answer whether SoluTab, a capsule or another oral product can be opened, chewed, crushed, split or mixed, and it does not replace the current label for the exact product." }, { "zh": "症状缓解或反复并不能从机制中推导出自我加减、长期续用或改用另一种产品。涉及持续不适、出血警示症状或多药并用时，应使用当地专业支持。", "en": "Symptom relief or recurrence cannot be used to derive self-adjustment, long-term continuation or a change to another product from mechanism. With persistent symptoms, bleeding-warning symptoms or multiple medicines, use local professional support." } ], "source": { "id": "src_fe786172b22ae19e", "label": "DailyMed（NLM）：PREVACID / PREVACID SoluTab 当前美国公开标签（Takeda；页面 2025-07 更新，处方信息 2025-03 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=71ba78cb-7e46-43eb-9425-fa130f537f84", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "Prevacid", "generic": "兰索拉唑", "dosageFormClass": "30 mg 延迟释放胶囊；15 mg、30 mg 延迟释放口崩片（DailyMed 2025-03 公开标签所列）" }, "labelSource": { "id": "src_fe786172b22ae19e", "label": "DailyMed（NLM）：PREVACID / PREVACID SoluTab 当前美国公开标签（Takeda，2025-03 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=71ba78cb-7e46-43eb-9425-fa130f537f84", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "productRoutes": [ { "source": { "id": "src_fe786172b22ae19e", "label": "DailyMed（NLM）：PREVACID / PREVACID SoluTab 当前美国公开标签（Takeda，2025-03 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=71ba78cb-7e46-43eb-9425-fa130f537f84", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_105e50cc8ece5018", "label": "FDA：PREVACID / PREVACID SoluTab 2014 美国标签档案（NDA 020406 / 021428）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021428s028lbl020406s081lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "DailyMed 的 Takeda PREVACID / PREVACID SoluTab 2025-03 美国公开标签列示 30 mg 延迟释放胶囊，以及 15 mg、30 mg 延迟释放口崩片，并标示美国初始批准年份为 1995。页面将三张官方包装面板与各自 NDC、剂型、每单位标示量及包装分开对应；不据此推定其他市场的批准、原研关系、供应、价格或可售资格。", "history": "“延迟释放”与“口崩”描述的是准确制剂的产品身份，不是自行改变、互换、叠加或按相同 mg 换算的依据。当前标签还明确，PREVACID 15 mg 胶囊并非 Takeda 当前在美国销售的规格；它不能与 15 mg SoluTab 混作同一产品。胶囊和 SoluTab 的操作规则也不同，须逐项回到准确市场、规格与现行标签核对。", "sourceDocuments": [ { "id": "src_fe786172b22ae19e", "label": "DailyMed（NLM）：PREVACID / PREVACID SoluTab 当前美国公开标签（Takeda，2025-03 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=71ba78cb-7e46-43eb-9425-fa130f537f84", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_105e50cc8ece5018", "label": "FDA：PREVACID / PREVACID SoluTab 2014 美国标签档案（NDA 020406 / 021428）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021428s028lbl020406s081lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_5ed30b676fbb9773", "label": "FDA Drugs@FDA 官方检索入口", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_lookup_entry", "documentKind": "regulatory_lookup", "market": "US", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } ], "applicationNumber": "NDA 020406 / 021428", "approvalTimeline": [ { "date": "1995", "title": { "zh": "FDA 标签所列美国初始批准年份", "en": "Initial U.S. approval year listed in the FDA label" }, "detail": { "zh": "本页链接的 FDA 标签档案列示 Initial U.S. Approval: 1995。该历史定位不等同于当前批准、可得性、持有人或其他市场状态。", "en": "The FDA label archive linked here lists Initial U.S. Approval: 1995. This historical locator is not a conclusion about current approval, availability, holder or another market." }, "source": { "id": "src_105e50cc8ece5018", "label": "FDA: PREVACID label archive", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021428s028lbl020406s081lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, { "date": "2014", "title": { "zh": "FDA 标签档案版本", "en": "FDA label archive version" }, "detail": { "zh": "本页链接 2014 的 FDA 标签档案作为可复核阅读入口。现行标签、规格、适应症和安全信息必须另行以目标市场当前文件核对。", "en": "This page links the 2014 FDA label archive as a traceable reading entry point. Current labeling, strength, indication and safety information require separate verification against the target market’s current document." }, "source": { "id": "src_105e50cc8ece5018", "label": "FDA: PREVACID label archive", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021428s028lbl020406s081lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "已链接公开标签档案", "en": "Public label archive linked" }, "detail": { "zh": "仅对应本页所列 FDA 文件。", "en": "Only the FDA document listed on this page is linked." } }, { "market": { "zh": "中国大陆、欧盟、日本", "en": "Mainland China, EU, Japan" }, "status": { "zh": "待逐项建立市场记录", "en": "Market record not established" }, "detail": { "zh": "不从美国标签档案推定当地批准、持有人、规格、供应或可售资格。", "en": "No local approval, holder, strength, supply or sale-eligibility conclusion is inferred from the U.S. label archive." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "标签档案能代表现在的产品信息吗？", "en": "Does a label archive represent current product information?" }, "answer": { "zh": "不能自动代表。档案用于定位来源；需要以目标市场的现行官方标签逐项复核。", "en": "Not automatically. The archive locates a source; each point needs verification against the target market’s current official label." } }, { "question": { "zh": "为什么这里不展示价格或原研/仿制结论？", "en": "Why are price and originator/generic conclusions not shown?" }, "answer": { "zh": "这些结论需要产品、剂型、规格、包装、市场、日期和原始记录分别齐全并经人工审核；单一标签文件不足以支持。", "en": "Those conclusions require separately complete and human-reviewed product, dosage-form, strength, pack, market, date and primary-record fields; one label file is insufficient." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "how-to-read-a-drug-label", "regulatory-sources-first" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/prevacid/", "en": "https://origindrug.com/en/drugs/prevacid/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "pepcid-famotidine", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-21", "status": "published_traceable_archive" }, "names": { "brand": "Pepcid AC Original Strength", "generic": "法莫替丁", "aliases": [ "PEPCID AC ORIGINAL STRENGTH", "Pepcid AC Original Strength", "famotidine" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "消化系统", "sourceArchiveMarket": "美国当前 PEPCID AC Original Strength 法莫替丁非处方公开标签（DailyMed SPL v20；2026-02-06 更新，2026-02-11 发布）", "dosageFormClass": "法莫替丁口服薄膜衣片（非处方）：每片 10 mg；本档案精确展示 NDC 16837-872-20、30 片纸盒（3 板 × 10 片）", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "美国当前公开标签记录（DailyMed SPL v20）", "archiveSponsorText": "Kenvue Brands LLC / DailyMed（NLM）当前公开 OTC 标签档案" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [ "Pepcid AC Original Strength" ], "excludedProductCues": [ "PEPCID COMPLETE", "calcium carbonate", "magnesium hydroxide", "PEPCID AC MAXIMUM STRENGTH", "Maximum Strength Pepcid", "famotidine 20 mg", "Pepcid 20 mg", "ICY COOL MINT", "compare to Pepcid", "repackaged" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-pepcid-ac-original-strength-famotidine-10mg-ndc-16837-872-20", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v20；2026-02-06 更新，2026-02-11 发布", "en": "DailyMed SPL v20; updated 6 Feb 2026 and published 11 Feb 2026" }, "dosageForm": { "zh": "法莫替丁口服薄膜衣片（非处方）", "en": "famotidine film-coated oral tablet (OTC)" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 16837-872-20", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片法莫替丁 10 mg；30 片纸盒（3 板 × 10 片）", "en": "Famotidine 10 mg per tablet; 30-tablet carton (3 blisters × 10 tablets)" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=54f4086f-e443-4e7e-8c7e-94e152e1c256&name=pepcid-01.jpg", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "法莫替丁", "en": "famotidine" }, "value": 10, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签含量；不是个人服用片数", "en": "labelled amount per tablet/caplet; not an individual's tablet count" } } ], "concentration": null, "container": { "typeCode": "blister_carton", "typeLabel": { "zh": "30 片纸盒（3 板 × 10 片）", "en": "30-tablet carton (3 blisters × 10 tablets)" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "片/盒", "en": "tablets per carton" }, "unitsPerContainer": { "count": 10, "unit": { "zh": "片/泡罩板", "en": "tablets per blister" } } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-19", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 30, "unit": { "zh": "片/盒", "en": "tablets per carton" } }, "physicalClues": { "color": { "zh": "白色药片（包装面板所示）", "en": "white tablet (as shown on the package panel)" }, "shape": { "zh": "包装面板未建立精确片形结论", "en": "exact tablet shape not established by this package panel" }, "imprint": "not established from this package panel", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_7896e214ce263808", "label": "DailyMed（NLM）：PEPCID AC Original Strength 法莫替丁当前美国公开标签（Kenvue；SPL v20）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=54f4086f-e443-4e7e-8c7e-94e152e1c256", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-pepcid-ac-original-strength-famotidine-10mg-ndc-16837-872-20", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=54f4086f-e443-4e7e-8c7e-94e152e1c256&name=pepcid-01.jpg", "alt": "PEPCID AC Original Strength 在美国 DailyMed 当前标签中的法莫替丁 10 mg、NDC 16837-872-20、30 片纸盒包装展示面", "archiveMarket": "美国", "labelVersion": "DailyMed SPL v20（2026-02-06 更新；2026-02-11 发布）", "presentation": "PEPCID AC Original Strength：法莫替丁每片 10 mg；NDC 16837-872-20；30 片纸盒（3 板 × 10 片）包装展示面。", "notice": "此图只对应美国当前 SPL v20 中 PEPCID AC Original Strength、法莫替丁每片 10 mg、NDC 16837-872-20 与 30 片纸盒（3 板 × 10 片）。它不用于鉴定真伪，也不代表 PEPCID AC Maximum Strength 20 mg、PEPCID Complete 复方、其他包装、其他市场、实际可得性或任何个人的片数、间隔、开始、停用、联用或替代方案。", "source": { "id": "src_7896e214ce263808", "label": "DailyMed（NLM）：PEPCID AC Original Strength 法莫替丁当前美国公开标签（Kenvue；SPL v20）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=54f4086f-e443-4e7e-8c7e-94e152e1c256", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "PEPCID AC Original Strength 说明书放大阅读：10 mg 是每片标签量，30 片是包装身份", "en": "PEPCID AC Original Strength label reading: 10 mg is the labelled amount per tablet and 30 tablets identify the package" }, "summary": { "zh": "本模块只阅读当前美国公开标签中的 PEPCID AC Original Strength、法莫替丁 10 mg、NDC 16837-872-20 与 30 片纸盒。它不提供个人片数、间隔、疗程、漏用处理、与其他胃药合用或换用方案。", "en": "This module reads only PEPCID AC Original Strength, famotidine 10 mg, NDC 16837-872-20 and the 30-tablet carton in the current U.S. public label. It provides no individual tablet count, interval, course, missed-use handling, co-use with another stomach medicine or switching plan." }, "checks": [ { "zh": "先把完整商品名、法莫替丁、每片 10 mg、NDC 16837-872-20、30 片纸盒（3 板 × 10 片）、口服薄膜衣片与目标市场一起核对。只看到“Pepcid”“法莫替丁”或“30 片”不能证明另一种强度、包装或市场产品相同。", "en": "Check the complete brand name, famotidine, 10 mg per tablet, NDC 16837-872-20, the 30-tablet carton (3 blisters × 10 tablets), film-coated oral tablet and target market together. Seeing only “Pepcid”, “famotidine” or “30 tablets” does not prove another strength, package or market product is the same." }, { "zh": "10 mg 是这一个标签片剂中每片的成分量；30 片和每板 10 片只描述包装。它们不是个人一次应服几片、每天几次、连续多久、漏用后如何补用或是否应加倍的规则。", "en": "10 mg is the ingredient amount in each tablet of this labelled product; 30 tablets and 10 tablets per blister only describe the package. They are not rules for how many tablets a person should use at once, how often, for how long, how to make up a missed use or whether to double." }, { "zh": "PEPCID AC Maximum Strength 20 mg 与本页 10 mg 不是同一强度；PEPCID Complete 还含碳酸钙和氢氧化镁，是复方产品。共同品牌、相近用途或都写“缓解胃灼热”都不能建立自行换用、叠加或轮换关系。", "en": "PEPCID AC Maximum Strength 20 mg is not this 10 mg strength; PEPCID Complete also contains calcium carbonate and magnesium hydroxide and is a combination product. A shared brand, similar use or heartburn wording does not establish self-switching, combining or alternating." }, { "zh": "若正在同时使用处方药、非处方药、补充剂或其他抑酸/胃肠产品，应带上全部实际药盒和完整药单请药师或医生核对。吞咽困难、呕血、黑便、不明原因体重下降、胸痛或其他急性/严重担忧，应优先使用当地医疗支持；网页不判断是否自行开始、继续、停用或改用。", "en": "When using prescription medicines, OTC products, supplements or another acid-reducing/gastrointestinal product, take every actual pack and the complete medicine list to a pharmacist or clinician for review. Difficulty swallowing, vomiting blood, black stools, unexplained weight loss, chest pain or another acute/serious concern requires local medical support first; this page does not decide self-starting, continuing, stopping or changing." } ], "source": { "id": "src_7896e214ce263808", "label": "DailyMed（NLM）：PEPCID AC Original Strength 法莫替丁当前美国公开标签（Kenvue；SPL v20）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=54f4086f-e443-4e7e-8c7e-94e152e1c256", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "法莫替丁怎样起作用：它阻断组胺 H2 受体相关的胃酸分泌路径", "en": "How famotidine works: it blocks a histamine H2 receptor pathway related to gastric-acid secretion" }, "summary": { "zh": "当前公开标签将法莫替丁归为 H2 阻滞剂，并描述其通过竞争性抑制组胺在胃细胞 H2 受体上的作用而抑制胃酸分泌。这个机制帮助阅读药物类别与同类产品边界；不预测个人症状原因、疗效、适用性、片数、间隔或是否可与其他胃药联用。", "en": "The current public label classifies famotidine as an H2 blocker and describes competitive inhibition of histamine action at gastric-cell H2 receptors, reducing gastric-acid secretion. This mechanism helps read the medicine class and family boundaries; it does not predict an individual's symptom cause, response, suitability, tablet count, interval or co-use with another stomach medicine." }, "checks": [ { "zh": "“H2 阻滞剂”“减少胃酸分泌”是类别与作用路径说明，不是从烧心、胃痛、夜间不适或一张药盒照片判断病因、风险或个人是否适合用药的工具。", "en": "“H2 blocker” and “reduces gastric-acid secretion” describe class and pathway; they are not tools for determining the cause, risk or individual suitability from heartburn, stomach pain, night-time discomfort or one package photograph." }, { "zh": "同样涉及胃酸或消化不适的产品可能是不同成分、强度、剂型或复方。机制词不能证明 PEPCID Complete、20 mg 产品、其他抑酸药或其他市场包装可以自行叠加、轮换或替代。", "en": "Products involving gastric acid or digestive discomfort may have different ingredients, strengths, forms or combinations. A mechanism word does not prove that PEPCID Complete, a 20 mg product, another acid reducer or another-market package can be self-combined, alternated or substituted." }, { "zh": "机制说明不能处理持续或加重症状、吞咽困难、出血相关迹象、胸痛、复杂多药联用或其他急性问题。此类情况应优先使用当地医疗与药师/医生支持，而不是从网页推导处理方案。", "en": "A mechanism explanation cannot manage persistent or worsening symptoms, swallowing difficulty, bleeding-related signs, chest pain, complex polypharmacy or another acute concern. Use local medical and pharmacist/clinician support first rather than deriving a plan from a webpage." } ], "source": { "id": "src_7896e214ce263808", "label": "DailyMed（NLM）：PEPCID AC Original Strength 法莫替丁当前美国公开标签（Kenvue；SPL v20）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=54f4086f-e443-4e7e-8c7e-94e152e1c256", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "Pepcid AC Original Strength", "generic": "法莫替丁", "dosageFormClass": "法莫替丁口服薄膜衣片（非处方）：每片 10 mg；本档案精确展示 NDC 16837-872-20、30 片纸盒（3 板 × 10 片）" }, "labelSource": { "id": "src_7896e214ce263808", "label": "DailyMed（NLM）：PEPCID AC Original Strength 法莫替丁当前美国公开标签（Kenvue；SPL v20）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=54f4086f-e443-4e7e-8c7e-94e152e1c256", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "productRoutes": [ { "source": { "id": "src_7896e214ce263808", "label": "DailyMed（NLM）：PEPCID AC Original Strength 法莫替丁当前美国公开标签（Kenvue；SPL v20）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=54f4086f-e443-4e7e-8c7e-94e152e1c256", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "DailyMed 当前 SPL v20 将本展示对象列为 PEPCID AC Original Strength 法莫替丁 10 mg 薄膜衣片，NDC 16837-872-20：30 片纸盒（3 板 × 10 片）。10 mg 是每片标签含量，30 片是包装身份，不是个人片数、间隔、疗程或补用规则。本页帮助核对准确产品、成分、包装和来源；不生成个人用药方案。", "history": "本档案只绑定 2026-02-06 更新、2026-02-11 发布的 DailyMed SPL v20 中 NDC 16837-872-20 的 Original Strength 10 mg、30 片包装面板。PEPCID AC Maximum Strength 20 mg 与 PEPCID Complete 的复方成分和包装均需按各自现行标签另行核对。", "sourceDocuments": [ { "id": "src_7896e214ce263808", "label": "DailyMed（NLM）：PEPCID AC Original Strength 法莫替丁当前美国公开标签（Kenvue；SPL v20）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=54f4086f-e443-4e7e-8c7e-94e152e1c256", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } ], "applicationNumber": "DailyMed SPL setid 54f4086f-e443-4e7e-8c7e-94e152e1c256（SPL v20）", "approvalTimeline": [ { "date": "2026-02-06", "title": { "zh": "当前 PEPCID AC Original Strength 标签更新", "en": "Current PEPCID AC Original Strength label updated" }, "detail": { "zh": "DailyMed 页面将这份美国公开标签的 Updated 日期列为 2026-02-06。本页只用该标签核对 Original Strength 10 mg、NDC 16837-872-20 与 30 片纸盒；不从标签日期推定实际在售、库存、购买或个人使用安排。", "en": "DailyMed lists 6 Feb 2026 as the Updated date for this U.S. public label. This page uses it only to check Original Strength 10 mg, NDC 16837-872-20 and the 30-tablet carton; the date does not establish actual marketing, stock, purchase or an individual's use plan." }, "source": { "id": "src_7896e214ce263808", "label": "DailyMed: current PEPCID AC Original Strength famotidine public label, SPL v20", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=54f4086f-e443-4e7e-8c7e-94e152e1c256", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, { "date": "2026-02-11", "title": { "zh": "DailyMed 发布 SPL v20", "en": "DailyMed published SPL v20" }, "detail": { "zh": "DailyMed 服务记录将该标签列为 SPL v20，并标示发布日期为 2026-02-11。发布时间与包装、个人片数、间隔、疗程、联用或替代结论无关。", "en": "The DailyMed service record lists this label as SPL v20, published 11 Feb 2026. A publication date does not determine package equivalence, individual tablet count, interval, course, co-use or substitution." }, "source": { "id": "src_7896e214ce263808", "label": "DailyMed: current PEPCID AC Original Strength famotidine public label, SPL v20", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=54f4086f-e443-4e7e-8c7e-94e152e1c256", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "已链接当前公开标签与一个精确包装面板", "en": "Current public label and one exact package panel linked" }, "detail": { "zh": "本页只展示 NDC 16837-872-20 的 Original Strength 法莫替丁 10 mg、30 片纸盒（3 板 × 10 片）。它不建立实际在售、库存、可得性、其他 NDC、Maximum Strength、PEPCID Complete 复方或个人适用性。", "en": "This page displays only Original Strength famotidine 10 mg, NDC 16837-872-20, in a 30-tablet carton (3 blisters × 10 tablets). It does not establish actual marketing, stock, availability, another NDC, Maximum Strength, the PEPCID Complete combination or individual suitability." } }, { "market": { "zh": "中国大陆、欧盟、日本及其他市场", "en": "Mainland China, EU, Japan and other markets" }, "status": { "zh": "待逐项建立市场记录", "en": "Market record not established" }, "detail": { "zh": "不从美国标签、NDC、英文品牌或包装图推定当地商品名、批准、供应、可售资格、原研/仿制关系或可替代性；每个市场须按当地现行监管资料单独核对。", "en": "No local trade name, approval, supply, sale eligibility, originator/generic relationship or interchangeability is inferred from the U.S. label, NDC, English brand or package image; each market requires separate checking against current local regulatory material." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "包装写 10 mg、30 片或每板 10 片，是否表示可以自行决定一次吃几片或多久吃一次？", "en": "Do 10 mg, 30 tablets or 10 tablets per blister on the package mean someone can decide how many to take at once or how often?" }, "answer": { "zh": "不是。这些是这个准确美国标签包装的成分和包装身份。页面不提供个人片数、间隔、疗程、漏用处理或加倍建议；应按手上准确标签并向药师或医生核对。", "en": "No. These are ingredient and package identities for this exact U.S.-labelled pack. This page provides no individual tablet count, interval, course, missed-use handling or doubling advice; use the exact label in hand and check with a pharmacist or clinician." } }, { "question": { "zh": "PEPCID Complete、Maximum Strength 或其他“胃药”能否按同品牌或相近用途自行换用、叠加或轮换？", "en": "Can PEPCID Complete, Maximum Strength or another “stomach medicine” be self-switched, combined or alternated because of a shared brand or similar use?" }, "answer": { "zh": "不能。PEPCID Complete 是复方，Maximum Strength 是不同强度；其他胃肠产品还可能有不同成分、剂型和风险边界。请带全部实际药盒、处方药、非处方药和补充剂让药师或医生逐项核对。", "en": "No. PEPCID Complete is a combination product and Maximum Strength is a different strength; other gastrointestinal products may also have different ingredients, forms and risk boundaries. Take all actual packs, prescription medicines, OTC products and supplements to a pharmacist or clinician for item-by-item review." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "dosage-forms-are-part-of-medicine-identity", "how-to-read-a-drug-label" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/pepcid-famotidine/", "en": "https://origindrug.com/en/drugs/pepcid-famotidine/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "reglan", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-23", "status": "published_traceable_archive" }, "names": { "brand": "REGLAN", "generic": "甲氧氯普胺", "aliases": [ "REGLAN", "metoclopramide", "metoclopramide hydrochloride", "甲氧氯普胺" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "消化系统", "sourceArchiveMarket": "美国 DailyMed 当前 REGLAN（metoclopramide hydrochloride）口服片标签，2026-02-09 更新。本档案仅对应标签列出的美国处方片及两个 NDC；不推定中国大陆或其他市场的当前批准、持有人、供应、可得性或个人适用性。", "dosageFormClass": "口服片：5 mg、10 mg（DailyMed 当前美国公开标签所列）", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "1979（DailyMed 当前美国公开标签所列美国初始批准）", "archiveSponsorText": "ANI Pharmaceuticals, Inc. / DailyMed 美国公开标签" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [ "metoclopramide injection", "甲氧氯普胺注射液", "metoclopramide oral solution", "metoclopramide ODT" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-reglan-metoclopramide-tablet-5mg-100bottle-ndc-62559-165-01", "marketCode": "US", "labelVersion": { "zh": "DailyMed 美国当前公开标签（2026-02-09 更新）", "en": "Current U.S. DailyMed public label (updated 9 Feb 2026)" }, "dosageForm": { "zh": "REGLAN 甲氧氯普胺口服片", "en": "REGLAN metoclopramide oral tablet" }, "route": { "zh": "口服（标签产品身份字段）", "en": "oral (label product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 62559-165-01", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片 5 mg；100 片瓶装", "en": "5 mg per tablet; 100-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=de55c133-eb08-4a35-91a2-5dc093027397&name=Label-5mg.jpg&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "甲氧氯普胺", "en": "metoclopramide" }, "value": 5, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、疗程或换算", "en": "labelled amount per tablet; not an individual's tablet count, course or conversion" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-23", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "绿色（标签描述）", "en": "green (label description)" }, "shape": { "zh": "椭圆形（标签描述）", "en": "elliptical (label description)" }, "imprint": "REGLAN / 5; ANI", "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_a91fbb4937695815", "label": "DailyMed（NLM）：REGLAN 甲氧氯普胺当前美国公开标签（ANI；2026-02-09 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?lang=en&setid=de55c133-eb08-4a35-91a2-5dc093027397", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-reglan-metoclopramide-tablet-10mg-100bottle-ndc-62559-166-01", "marketCode": "US", "labelVersion": { "zh": "DailyMed 美国当前公开标签（2026-02-09 更新）", "en": "Current U.S. DailyMed public label (updated 9 Feb 2026)" }, "dosageForm": { "zh": "REGLAN 甲氧氯普胺口服片", "en": "REGLAN metoclopramide oral tablet" }, "route": { "zh": "口服（标签产品身份字段）", "en": "oral (label product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 62559-166-01", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片 10 mg；100 片瓶装", "en": "10 mg per tablet; 100-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=de55c133-eb08-4a35-91a2-5dc093027397&name=Label-10mg.jpg&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "甲氧氯普胺", "en": "metoclopramide" }, "value": 10, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、疗程或换算", "en": "labelled amount per tablet; not an individual's tablet count, course or conversion" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-23", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "白色（标签描述）", "en": "white (label description)" }, "shape": { "zh": "胶囊形、双边刻痕（标签描述）", "en": "capsule-shaped, double-edge scored (label description)" }, "imprint": "REGLAN; ANI 10", "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_a91fbb4937695815", "label": "DailyMed（NLM）：REGLAN 甲氧氯普胺当前美国公开标签（ANI；2026-02-09 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?lang=en&setid=de55c133-eb08-4a35-91a2-5dc093027397", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-reglan-metoclopramide-tablet-5mg-100bottle-ndc-62559-165-01", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=de55c133-eb08-4a35-91a2-5dc093027397&name=Label-5mg.jpg&type=img", "alt": "REGLAN 甲氧氯普胺在美国 DailyMed 当前标签中的 5 mg、NDC 62559-165-01、100 片瓶装展示面", "archiveMarket": "美国", "labelVersion": "DailyMed 美国当前公开标签（2026-02-09 更新）", "presentation": "REGLAN 甲氧氯普胺：每片 5 mg，NDC 62559-165-01，100 片瓶装。", "notice": "此图只对应美国 DailyMed 当前标签中的 REGLAN、甲氧氯普胺、每片 5 mg、NDC 62559-165-01 与 100 片瓶装。它只帮助核对品牌、通用名、每片标签量、包装数量和来源；不用于鉴定真伪，也不证明 10 mg 产品、其他包装、其他市场、当前可得性、原研身份、可替代性，或任何个人的片数、时间、开始、停用、联用或换药方案。", "source": { "id": "src_a91fbb4937695815", "label": "DailyMed（NLM）：REGLAN 甲氧氯普胺当前美国公开标签（ANI；2026-02-09 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?lang=en&setid=de55c133-eb08-4a35-91a2-5dc093027397", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "REGLAN 说明书放大阅读：5、10 mg 是片剂身份，不是“该吃几片”", "en": "REGLAN label reading: 5 and 10 mg identify tablets; they do not answer “how many tablets”" }, "summary": { "zh": "本模块只阅读 DailyMed 当前美国标签中的 REGLAN、甲氧氯普胺、口服片、每片标示量和黑框警告。它不提供个人片数、起止时间、联用、换药或购买方案。", "en": "This module reads only REGLAN, metoclopramide, oral tablets, labelled amount per tablet and the boxed warning in the current U.S. DailyMed label. It provides no individual tablet count, start/stop timing, co-use, switching or purchase plan." }, "checks": [ { "zh": "把 REGLAN、甲氧氯普胺、口服片、每片 5 或 10 mg、NDC、实际包装和目标市场一起核对。mg 是一片准确产品的标示量，不是网页可以换算成个人每天该用多少片的规则，也不能据此把注射剂、口服液、口崩片、另一市场产品或另一种药自行互换。", "en": "Check REGLAN, metoclopramide, oral-tablet form, the stated 5 or 10 mg per tablet, NDC, actual pack and target market together. Mg is the labelled amount in an exact tablet, not a web rule for how many tablets an individual should use, and it cannot self-convert an injection, oral solution, orally disintegrating tablet, another-market product or another medicine." }, { "zh": "该标签的黑框警告涉及迟发性运动障碍；标签写明风险与治疗持续时间及累计暴露有关。这个警示用于提醒核对准确说明书和完整药单，不应被网页转写为任何个人开始、减少、停用、续用或换药指令。出现新的不自主动作、意识或呼吸方面的急性严重不适时，应优先使用当地紧急医疗渠道。", "en": "The label's boxed warning concerns tardive dyskinesia and states that risk relates to treatment duration and total cumulative exposure. This warning is a cue to check the exact leaflet and complete medicine list; a webpage must not turn it into an individual start, reduction, stopping, continuation or switching instruction. New involuntary movements or an acute serious concern involving consciousness or breathing require local urgent-care channels first." }, { "zh": "标签列出抗精神病药、中枢神经系统抑制剂、强 CYP2D6 抑制剂、MAO 抑制剂等相互作用线索，也特别提示帕金森病、癫痫、既往运动障碍、肝肾功能、年龄与多药并用需要专业复核。请把所有处方药、非处方药、草本和补充剂连同实际药盒交给药师或开方团队逐项核对；不要仅因名称相似或都是“胃肠道用药”就自行叠加或替代。", "en": "The label identifies interaction cues involving antipsychotics, central-nervous-system depressants, strong CYP2D6 inhibitors and MAO inhibitors, and flags Parkinson's disease, epilepsy, prior movement disorders, liver/kidney context, age and multiple medicines for professional review. Have a pharmacist or prescribing team check every prescription, OTC product, herb and supplement together with the actual packs; do not self-combine or substitute simply because names look similar or both are described as gastrointestinal medicines." }, { "zh": "本页对应的是 2026 年美国处方片标签，不能替代手中药盒随附的现行说明书。漏用、吞咽困难、包装不一致、准备掰开/研碎，或希望改变任何治疗时，应先请了解实际产品和目标市场标签的药师或医疗团队审阅。", "en": "This page corresponds to a 2026 U.S. prescription-tablet label and cannot replace the current leaflet supplied with the product in hand. For a missed use, swallowing difficulty, pack mismatch, contemplated splitting/crushing or any treatment change, first have a pharmacist or care team familiar with the actual product and target-market label review it." } ], "source": { "id": "src_a91fbb4937695815", "label": "DailyMed（NLM）：REGLAN 甲氧氯普胺当前美国公开标签（ANI；2026-02-09 更新；黑框警告、片剂身份与相互作用）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?lang=en&setid=de55c133-eb08-4a35-91a2-5dc093027397", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "甲氧氯普胺怎样起作用：标签描述的多巴胺受体拮抗与胃肠动力路径", "en": "How metoclopramide works: the label's dopamine-receptor antagonism and gastrointestinal-motility pathway" }, "summary": { "zh": "DailyMed 当前标签描述，甲氧氯普胺在中枢具有多巴胺 D2 受体拮抗作用，并增强上消化道动力。机制解释用于理解一条药理路径；它不判断个人症状原因、是否适合、每次片数、联用、停用或替代。", "en": "The current DailyMed label describes central dopamine D2 receptor antagonism and enhanced upper-gastrointestinal motility with metoclopramide. This explains one pharmacologic pathway; it does not determine an individual's symptom cause, suitability, tablet count, co-use, stopping or replacement." }, "checks": [ { "zh": "“多巴胺 D2 受体拮抗”“增强胃肠动力”是药理路径用语，不表示所有止吐、促动力、抗精神病或相近用途产品可以自行叠加、轮换或按 mg 对等换算。", "en": "“Dopamine D2 receptor antagonism” and “enhanced gastrointestinal motility” are pharmacologic-pathway terms; they do not establish that antiemetic, pro-motility, antipsychotic or similarly used products can be self-combined, alternated or milligram-converted." }, { "zh": "同样出现“反胃”“胃食管反流”“胃轻瘫”或“多巴胺”文字，也不能证明两盒药适用于同一疾病、同一人或同一市场。应先核对准确商品名、通用名、片剂强度、目标市场标签和完整药单。", "en": "Shared words such as “nausea,” “gastroesophageal reflux,” “gastroparesis” or “dopamine” do not establish that two packs apply to the same condition, person or market. First check the exact brand, generic name, tablet strength, target-market label and complete medicine list." }, { "zh": "机制解释不能替代黑框警告、相互作用或药物警戒核对。涉及新增抗精神病药、镇静药、抗抑郁药、其他处方或非处方产品，或出现新的不自主动作、严重不适时，应让药师或医疗团队审阅完整药单；急性严重情况优先使用当地紧急医疗渠道。", "en": "A mechanism explanation does not replace boxed-warning, interaction or pharmacovigilance review. When an antipsychotic, sedating medicine, antidepressant, another prescription or OTC product is added, or a new involuntary movement or serious concern occurs, have a pharmacist or care team review the full medicine list; use local urgent-care channels first for an acute serious concern." } ], "source": { "id": "src_a91fbb4937695815", "label": "DailyMed（NLM）：REGLAN 甲氧氯普胺当前美国公开标签（ANI；2026-02-09 更新；Clinical Pharmacology）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?lang=en&setid=de55c133-eb08-4a35-91a2-5dc093027397", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "REGLAN", "generic": "甲氧氯普胺", "dosageFormClass": "口服片：5 mg、10 mg（DailyMed 当前美国公开标签所列）" }, "labelSource": { "id": "src_a91fbb4937695815", "label": "DailyMed（NLM）：REGLAN 甲氧氯普胺当前美国公开标签（ANI；2026-02-09 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?lang=en&setid=de55c133-eb08-4a35-91a2-5dc093027397", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "productRoutes": [ { "source": { "id": "src_a91fbb4937695815", "label": "DailyMed（NLM）：REGLAN 甲氧氯普胺当前美国公开标签（ANI；2026-02-09 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?lang=en&setid=de55c133-eb08-4a35-91a2-5dc093027397", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-23", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-23", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "DailyMed 当前美国公开标签将 REGLAN 列为甲氧氯普胺口服片，并列出 5 mg、10 mg 两种每片标示量。本页把商品名、通用名、片剂、每片标示量、准确 NDC、包装展示面和原始说明书入口并列；“mg”只用于核对准确产品身份，不转换为个人片数、开始、停用、联用、换药或购买结论。", "history": "该美国公开标签列示 Initial U.S. Approval: 1979，页面更新日期为 2026-02-09。其黑框警告涉及迟发性运动障碍；本页只锚定这一美国文件和两个对应 100 片瓶装展示面。不同剂型、不同包装、不同市场或同通用名产品均须按实际药盒和所在市场现行官方资料分别核对。", "sourceDocuments": [ { "id": "src_a91fbb4937695815", "label": "DailyMed（NLM）：REGLAN 甲氧氯普胺当前美国公开标签（ANI；2026-02-09 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?lang=en&setid=de55c133-eb08-4a35-91a2-5dc093027397", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" } ], "applicationNumber": "NDA (current DailyMed label; application number not asserted in this dossier)", "approvalTimeline": [ { "date": "1979", "title": { "zh": "FDA 标签所列美国初始批准年份", "en": "Initial U.S. approval year listed in the FDA label" }, "detail": { "zh": "本页链接的 FDA 标签档案列示 Initial U.S. Approval: 1979。该历史定位不等同于当前批准、可得性、持有人或其他市场状态。", "en": "The FDA label archive linked here lists Initial U.S. Approval: 1979. This historical locator is not a conclusion about current approval, availability, holder or another market." }, "source": { "id": "src_a91fbb4937695815", "label": "DailyMed: current REGLAN metoclopramide U.S. public label", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?lang=en&setid=de55c133-eb08-4a35-91a2-5dc093027397", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" } }, { "date": "2026-02-09", "title": { "zh": "FDA 标签档案版本", "en": "FDA label archive version" }, "detail": { "zh": "本页链接 2026-02-09 的 FDA 标签档案作为可复核阅读入口。现行标签、规格、适应症和安全信息必须另行以目标市场当前文件核对。", "en": "This page links the 2026-02-09 FDA label archive as a traceable reading entry point. Current labeling, strength, indication and safety information require separate verification against the target market’s current document." }, "source": { "id": "src_a91fbb4937695815", "label": "DailyMed: current REGLAN metoclopramide U.S. public label", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?lang=en&setid=de55c133-eb08-4a35-91a2-5dc093027397", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "已链接公开标签档案", "en": "Public label archive linked" }, "detail": { "zh": "仅对应本页所列 FDA 文件。", "en": "Only the FDA document listed on this page is linked." } }, { "market": { "zh": "中国大陆、欧盟、日本", "en": "Mainland China, EU, Japan" }, "status": { "zh": "待逐项建立市场记录", "en": "Market record not established" }, "detail": { "zh": "不从美国标签档案推定当地批准、持有人、规格、供应或可售资格。", "en": "No local approval, holder, strength, supply or sale-eligibility conclusion is inferred from the U.S. label archive." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "标签档案能代表现在的产品信息吗？", "en": "Does a label archive represent current product information?" }, "answer": { "zh": "不能自动代表。档案用于定位来源；需要以目标市场的现行官方标签逐项复核。", "en": "Not automatically. The archive locates a source; each point needs verification against the target market’s current official label." } }, { "question": { "zh": "为什么这里不展示价格或原研/仿制结论？", "en": "Why are price and originator/generic conclusions not shown?" }, "answer": { "zh": "这些结论需要产品、剂型、规格、包装、市场、日期和原始记录分别齐全并经人工审核；单一标签文件不足以支持。", "en": "Those conclusions require separately complete and human-reviewed product, dosage-form, strength, pack, market, date and primary-record fields; one label file is insufficient." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "how-to-read-a-drug-label", "regulatory-sources-first" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/reglan/", "en": "https://origindrug.com/en/drugs/reglan/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "protonix", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-20", "status": "published_traceable_archive" }, "names": { "brand": "Protonix", "generic": "泮托拉唑", "aliases": [ "pantoprazole", "泮托拉唑", "泮立苏" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "消化系统", "sourceArchiveMarket": "美国公开处方药标签档案（DailyMed 2026-05 版本）", "dosageFormClass": "口服延迟释放片：20 mg、40 mg；另有延迟释放口服混悬液，属于不同产品形态（本档案所列）", "dosageFormClassCode": "oral_modified_release", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "2000（DailyMed 美国公开标签所列初始批准）", "archiveSponsorText": "Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. / DailyMed（NLM）公开标签档案" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-protonix-dr-tablet-20mg-ndc-0008-0843-81", "marketCode": "US", "labelVersion": { "zh": "DailyMed 公开标签（2026-05 更新）", "en": "DailyMed public label (updated May 2026)" }, "dosageForm": { "zh": "泮托拉唑钠延迟释放口服片", "en": "pantoprazole sodium delayed-release oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 0008-0843-81", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片 20 mg；90 片瓶装", "en": "20 mg per tablet; 90-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=protonix-04.jpg&setid=08098cb2-c048-4640-f387-6beec4a38936&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "泮托拉唑", "en": "pantoprazole" }, "value": 20, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标示量", "en": "labelled amount per tablet" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": null, "package": { "count": 90, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "黄色", "en": "yellow" }, "shape": { "zh": "椭圆、双凸延迟释放片", "en": "oval biconvex delayed-release tablet" }, "imprint": { "zh": "P20（棕色油墨）", "en": "P20 (brown ink)" }, "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_57758deeadc2e982", "label": "DailyMed（NLM）：PROTONIX 20 mg 延迟释放片、90 片瓶装（NDC 0008-0843-81；2026-05 更新）", "url": "https://www.dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=08098cb2-c048-4640-f387-6beec4a38936", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-protonix-dr-tablet-40mg-ndc-0008-0841-81", "marketCode": "US", "labelVersion": { "zh": "DailyMed 公开标签（2026-05 更新）", "en": "DailyMed public label (updated May 2026)" }, "dosageForm": { "zh": "泮托拉唑钠延迟释放口服片", "en": "pantoprazole sodium delayed-release oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 0008-0841-81", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片 40 mg；90 片瓶装", "en": "40 mg per tablet; 90-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=protonix-05.jpg&setid=08098cb2-c048-4640-f387-6beec4a38936&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "泮托拉唑", "en": "pantoprazole" }, "value": 40, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标示量", "en": "labelled amount per tablet" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": null, "package": { "count": 90, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "黄色", "en": "yellow" }, "shape": { "zh": "椭圆、双凸延迟释放片", "en": "oval biconvex delayed-release tablet" }, "imprint": { "zh": "PROTONIX（棕色油墨）", "en": "PROTONIX (brown ink)" }, "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_57758deeadc2e982", "label": "DailyMed（NLM）：PROTONIX 40 mg 延迟释放片、90 片瓶装（NDC 0008-0841-81；2026-05 更新）", "url": "https://www.dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=08098cb2-c048-4640-f387-6beec4a38936", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-protonix-dr-oral-suspension-40mg-ndc-0008-0844-02", "marketCode": "US", "labelVersion": { "zh": "DailyMed 公开标签（2026-05 更新）", "en": "DailyMed public label (updated May 2026)" }, "dosageForm": { "zh": "泮托拉唑钠延迟释放口服混悬液颗粒（单剂量袋装）", "en": "pantoprazole sodium delayed-release oral-suspension granules (unit-dose packet)" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 0008-0844-02", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_packet", "primaryDisplay": { "zh": "每袋 40 mg；30 袋单剂量外盒", "en": "40 mg per packet; 30 unit-dose packets per carton" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=protonix-07.jpg&setid=08098cb2-c048-4640-f387-6beec4a38936&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "泮托拉唑", "en": "pantoprazole" }, "value": 40, "unit": "mg", "basisCode": "per_packet", "basisLabel": { "zh": "每袋标示量", "en": "labelled amount per packet" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": null, "package": { "count": 30, "unit": { "zh": "单剂量袋/外盒", "en": "unit-dose packets per carton" } }, "physicalClues": { "color": { "zh": "淡黄至深棕色", "en": "pale yellowish to dark brownish" }, "shape": { "zh": "肠溶颗粒单剂量袋装", "en": "enteric-coated granules in a unit-dose packet" }, "imprint": null, "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_57758deeadc2e982", "label": "DailyMed（NLM）：PROTONIX 40 mg 延迟释放口服混悬液、30 袋单剂量外盒（NDC 0008-0844-02；2026-05 更新）", "url": "https://www.dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=08098cb2-c048-4640-f387-6beec4a38936", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": null, "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=protonix-05.jpg&setid=08098cb2-c048-4640-f387-6beec4a38936&type=img", "alt": "PROTONIX 40 mg 泮托拉唑钠延迟释放片在美国 DailyMed 公开标签中的 90 片瓶装主展示图", "archiveMarket": "美国", "labelVersion": "DailyMed 公开标签（Wyeth/Pfizer，2026-05 更新）", "presentation": "PROTONIX 泮托拉唑钠 40 mg 延迟释放片、NDC 0008-0841-81、90 片瓶装主展示图（DailyMed 公开标签所列）。", "notice": "此为美国 DailyMed 公开标签中明确对应 PROTONIX、泮托拉唑钠 40 mg 延迟释放片、NDC 0008-0841-81、90 片瓶装的 Wyeth/Pfizer 主展示图，只帮助核对品牌、通用名、标示强度、延迟释放片、包装数量和来源；不用于鉴定真伪，也不证明 20 mg、延迟释放口服混悬液、其他包装、其他市场标签、当前可得性、原研身份、目标市场批准或可售资格。", "source": { "id": "src_57758deeadc2e982", "label": "DailyMed（NLM）：PROTONIX 泮托拉唑钠延迟释放片及口服混悬液公开标签（Wyeth/Pfizer，2026-05 更新）", "url": "https://www.dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=08098cb2-c048-4640-f387-6beec4a38936", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "PROTONIX 说明书放大阅读：延迟释放、20 mg、40 mg 与口服混悬液先用于确认准确产品", "en": "PROTONIX label reading: delayed release, 20 mg, 40 mg and oral suspension first identify the exact product" }, "summary": { "zh": "本模块以美国 DailyMed 公开标签为阅读入口，帮助核对 PROTONIX、泮托拉唑钠、延迟释放片或延迟释放口服混悬液、每单位标示量和目标市场。它不提供任何人的片数、服用时间、疗程、联用、转换或停药方案。", "en": "This module uses the U.S. DailyMed public label to check PROTONIX, pantoprazole sodium, delayed-release tablets or delayed-release oral suspension, labelled amount per unit and target market. It does not provide an individual's tablet count, timing, course, combination, switching or stopping plan." }, "checks": [ { "zh": "20 mg、40 mg 是美国标签所列延迟释放片的每片标示量；它们是产品身份字段，不是网页为任何人计算今天应服几片、何时服或服多久的答案。先同时核对 PROTONIX、泮托拉唑、准确剂型、每单位量、实际包装和目标市场。", "en": "20 mg and 40 mg are labelled amounts per delayed-release tablet in the U.S. label. They are product-identity fields, not a webpage answer for how many tablets anyone should use today, when to use them or for how long. Check PROTONIX, pantoprazole, exact dosage form, amount per unit, actual pack and target market together." }, { "zh": "“延迟释放”描述制剂设计，不能简化为“掰一半就等于减半”或“另一种胃药都能互换”。片剂与延迟释放口服混悬液是标签中分别列出的产品形态；任何掰开、压碎、改成液体、换规格或换产品的问题，都需要准确产品的现行标签和药师确认。", "en": "“Delayed release” describes formulation design; it cannot be simplified to ‘half a tablet equals half’ or ‘any other stomach medicine is interchangeable.’ The label lists tablets and delayed-release oral suspension as separate product forms. Any splitting, crushing, changing to liquid, strength change or product change needs the current label for the exact product and pharmacist confirmation." }, { "zh": "标签包含与药物吸收、胃酸环境、肝功能、长期使用风险和其他药物相关的核对事项。正在使用处方药、非处方止痛药、补充剂或多种胃肠产品时，应把实际药盒和完整药单交由专业人员一起核对；不要按名称相近或“都是抑酸药”自行叠加、轮换或替代。", "en": "The label contains checks involving medicine absorption, gastric-acid environment, liver function, long-term-use risks and other medicines. With prescriptions, OTC pain medicines, supplements or multiple gastrointestinal products, have a professional review the actual packs and complete medicine list together; do not self-combine, alternate or substitute based on similar names or ‘acid medicine’ wording." }, { "zh": "吞咽困难、持续或加重的不适、呕血/黑便、体重明显变化、严重过敏表现或任何急性问题，不能由网页或包装数字处理。应及时使用当地医疗渠道，并将准确药盒、处方与完整药单交由专业人员判断。", "en": "Swallowing difficulty, persistent or worsening concerns, vomiting blood/black stools, marked weight change, severe allergic features or any acute problem cannot be handled from a webpage or package numbers. Use local medical pathways promptly and have professionals review the exact pack, prescription and complete medicine list." } ], "source": { "id": "src_57758deeadc2e982", "label": "DailyMed（NLM）：PROTONIX 泮托拉唑钠延迟释放片及口服混悬液公开标签（Wyeth/Pfizer，2026-05 更新）", "url": "https://www.dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=08098cb2-c048-4640-f387-6beec4a38936", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "泮托拉唑怎样起作用：标签将其归为质子泵抑制剂", "en": "How pantoprazole works: the label classifies it as a proton-pump inhibitor" }, "summary": { "zh": "DailyMed 标签将 PROTONIX 描述为质子泵抑制剂；其临床药理部分说明泮托拉唑可抑制胃壁细胞分泌胃酸的末端步骤。它解释的是药理路径和为何延迟释放等产品身份重要，不判断个人症状原因、是否适用、片数、疗程、联用或转换方案。", "en": "The DailyMed label describes PROTONIX as a proton-pump inhibitor; its clinical-pharmacology section explains that pantoprazole inhibits the final step of gastric-acid secretion in parietal cells. This explains a pharmacologic pathway and why product identity such as delayed release matters; it does not determine an individual's symptom cause, suitability, tablet count, course, combination or switching plan." }, "checks": [ { "zh": "“抑制胃酸分泌”是作用路径，不是对胸痛、腹痛、反酸、吞咽困难或其他症状的自我诊断，也不证明某个人一定适合某种抑酸产品。是否需要检查、治疗或改变方案应由当地医疗专业人员和现行标签判断。", "en": "‘Inhibits gastric-acid secretion’ is an action pathway, not self-diagnosis for chest pain, abdominal pain, reflux, swallowing difficulty or another symptom, and does not establish that a particular acid-reducing product suits someone. The need for evaluation, treatment or a change requires local clinical judgement and the current label." }, { "zh": "共同属于质子泵抑制剂或都写有胃酸相关用途，不支持把 PROTONIX 与另一种同类产品自行叠加、隔天轮换、按 mg 换算或以另一剂型替代。准确产品、既往反应、其他药物、检查计划和完整药单需由专业人员一起核对。", "en": "A shared proton-pump-inhibitor class or acid-related wording does not support self-combining PROTONIX with another related product, alternating by day, converting by milligrams or substituting another form. The exact product, prior reactions, other medicines, evaluation plan and complete medicine list need professional review together." }, { "zh": "机制页面不能替代对长期不适、出血警讯、脱水、肝肾问题、营养状况或任何新症状的个人处理。出现急性或严重问题时，应优先使用当地紧急医疗支持，而不是依据本页自行开始、加量、停用或换药。", "en": "A mechanism page cannot replace personal management of persistent symptoms, bleeding warning signs, dehydration, liver/kidney concerns, nutritional status or any new concern. With an acute or serious problem, prioritise local urgent medical support rather than self-starting, increasing, stopping or switching from this page." } ], "source": { "id": "src_57758deeadc2e982", "label": "DailyMed（NLM）：PROTONIX 泮托拉唑钠公开标签（Clinical Pharmacology，2026-05 更新）", "url": "https://www.dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=08098cb2-c048-4640-f387-6beec4a38936", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "Protonix", "generic": "泮托拉唑", "dosageFormClass": "口服延迟释放片：20 mg、40 mg；另有延迟释放口服混悬液，属于不同产品形态（本档案所列）" }, "labelSource": { "id": "src_57758deeadc2e982", "label": "DailyMed（NLM）：PROTONIX 泮托拉唑钠延迟释放片及口服混悬液公开标签（Wyeth/Pfizer，2026-05 更新）", "url": "https://www.dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=08098cb2-c048-4640-f387-6beec4a38936", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "productRoutes": [ { "source": { "id": "src_57758deeadc2e982", "label": "DailyMed（NLM）：PROTONIX 泮托拉唑钠延迟释放片及口服混悬液公开标签（Wyeth/Pfizer，2026-05 更新）", "url": "https://www.dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=08098cb2-c048-4640-f387-6beec4a38936", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "DailyMed 的 PROTONIX（pantoprazole sodium）美国公开标签将其列为口服延迟释放片，并列示 20 mg、40 mg；同一标签还列有延迟释放口服混悬液。页面帮助读者把品牌、通用名、延迟释放这一剂型属性、每单位标示量、实际包装和目标市场一起核对；不据此生成个人片数、时间表、疗程、联用、转换或停药方案。", "history": "DailyMed 页面列示 PROTONIX 的 Initial U.S. approval: 2000，并将延迟释放片与延迟释放口服混悬液分别列示。相同通用名、同样写有“胃药”或包装上相近的 mg 数字，都不足以证明能够掰开、研碎、换剂型、互换或自行调整；均须回到手上准确产品的现行标签、处方和药师/医生核对。", "sourceDocuments": [ { "id": "src_57758deeadc2e982", "label": "DailyMed（NLM）：PROTONIX 泮托拉唑钠延迟释放片及口服混悬液公开标签（Wyeth/Pfizer，2026-05 更新）", "url": "https://www.dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=08098cb2-c048-4640-f387-6beec4a38936", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_49b7631ac5ba52a6", "label": "FDA：PROTONIX 美国 NDA 历史资料（20-987 片剂、22-020 延迟释放口服混悬液）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/022020s000_NameR.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "approval_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_5ed30b676fbb9773", "label": "FDA Drugs@FDA 官方检索入口", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_lookup_entry", "documentKind": "regulatory_lookup", "market": "US", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } ], "applicationNumber": "NDA 020987 / 022020", "approvalTimeline": [ { "date": "2000", "title": { "zh": "FDA 标签所列美国初始批准年份", "en": "Initial U.S. approval year listed in the FDA label" }, "detail": { "zh": "本页链接的 FDA 标签档案列示 Initial U.S. Approval: 2000。该历史定位不等同于当前批准、可得性、持有人或其他市场状态。", "en": "The FDA label archive linked here lists Initial U.S. Approval: 2000. This historical locator is not a conclusion about current approval, availability, holder or another market." }, "source": { "id": "src_57758deeadc2e982", "label": "DailyMed: PROTONIX public label archive", "url": "https://www.dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=08098cb2-c048-4640-f387-6beec4a38936", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, { "date": "2026-05", "title": { "zh": "FDA 标签档案版本", "en": "FDA label archive version" }, "detail": { "zh": "本页链接 2026-05 的 FDA 标签档案作为可复核阅读入口。现行标签、规格、适应症和安全信息必须另行以目标市场当前文件核对。", "en": "This page links the 2026-05 FDA label archive as a traceable reading entry point. Current labeling, strength, indication and safety information require separate verification against the target market’s current document." }, "source": { "id": "src_57758deeadc2e982", "label": "DailyMed: PROTONIX public label archive", "url": "https://www.dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=08098cb2-c048-4640-f387-6beec4a38936", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "已链接公开标签档案", "en": "Public label archive linked" }, "detail": { "zh": "仅对应本页所列 FDA 文件。", "en": "Only the FDA document listed on this page is linked." } }, { "market": { "zh": "中国大陆、欧盟、日本", "en": "Mainland China, EU, Japan" }, "status": { "zh": "待逐项建立市场记录", "en": "Market record not established" }, "detail": { "zh": "不从美国标签档案推定当地批准、持有人、规格、供应或可售资格。", "en": "No local approval, holder, strength, supply or sale-eligibility conclusion is inferred from the U.S. label archive." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "标签档案能代表现在的产品信息吗？", "en": "Does a label archive represent current product information?" }, "answer": { "zh": "不能自动代表。档案用于定位来源；需要以目标市场的现行官方标签逐项复核。", "en": "Not automatically. The archive locates a source; each point needs verification against the target market’s current official label." } }, { "question": { "zh": "为什么这里不展示价格或原研/仿制结论？", "en": "Why are price and originator/generic conclusions not shown?" }, "answer": { "zh": "这些结论需要产品、剂型、规格、包装、市场、日期和原始记录分别齐全并经人工审核；单一标签文件不足以支持。", "en": "Those conclusions require separately complete and human-reviewed product, dosage-form, strength, pack, market, date and primary-record fields; one label file is insufficient." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "how-to-read-a-drug-label", "regulatory-sources-first" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/protonix/", "en": "https://origindrug.com/en/drugs/protonix/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "enbrel", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-17", "status": "published_traceable_archive" }, "names": { "brand": "Enbrel", "generic": "依那西普", "aliases": [ "etanercept" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "免疫", "sourceArchiveMarket": "美国公开监管标签档案", "dosageFormClass": "皮下注射：50 mg/mL 单剂量 SureClick 预充式自动注射器（本页包装图特定展示）", "dosageFormClassCode": "subcutaneous_injection", "route": "皮下注射", "routeCode": "subcutaneous", "historicalApprovalEntry": "1998（DailyMed 公开标签所列美国初始批准）", "archiveSponsorText": "Immunex Corporation / DailyMed 公开监管标签档案" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-enbrel-etanercept-50mg-1ml-four-sureclick-autoinjectors-ndc-58406-032-04", "marketCode": "US", "labelVersion": { "zh": "DailyMed 美国公开标签（Immunex；2026-02 更新）", "en": "DailyMed U.S. public label (Immunex; updated Feb 2026)" }, "dosageForm": { "zh": "ENBREL 依那西普单剂量 SureClick 预充式自动注射器", "en": "ENBREL etanercept single-dose SureClick prefilled autoinjector" }, "route": { "zh": "皮下注射（标签产品身份字段）", "en": "subcutaneous injection (label product-identity field)" }, "routeCodes": [ "subcutaneous_injection" ], "productCode": "NDC 58406-032-04", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_single_dose_prefilled_autoinjector", "primaryDisplay": { "zh": "每支 SureClick 单剂量预充式自动注射器含依那西普 50 mg/1 mL；每盒 4 支", "en": "Etanercept 50 mg/1 mL per single-dose SureClick prefilled autoinjector; 4 autoinjectors per carton" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=enbrel-204.jpg&setid=a002b40c-097d-47a5-957f-7a7b1807af7f&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "依那西普", "en": "etanercept" }, "value": 50, "unit": "mg", "basisCode": "per_single_dose_prefilled_autoinjector", "basisLabel": { "zh": "每支单剂量 SureClick 的标签含量；不是个人注射次数、转换或换药规则", "en": "labelled content per single-dose SureClick; not an individual's injection count, conversion or switching rule" } } ], "concentration": null, "container": { "typeCode": "single_dose_prefilled_autoinjector", "typeLabel": { "zh": "带 27G、1/2 英寸针的单剂量 SureClick 预充式自动注射器", "en": "single-dose SureClick prefilled autoinjector with 27-gauge, 1/2-inch needle" }, "fill": { "value": 1, "unit": "mL" }, "countPerPackage": null, "countUnit": null }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-28", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 4, "unit": { "zh": "支单剂量预充式自动注射器/盒", "en": "single-dose prefilled autoinjectors per carton" } }, "physicalClues": { "color": null, "shape": { "zh": "四支装 SureClick 自动注射器纸盒", "en": "four-device SureClick autoinjector carton" }, "imprint": null, "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_8b968f7e21859232", "label": "DailyMed（NLM）：ENBREL 50 mg/mL 四支 SureClick 自动注射器美国公开标签面板（Immunex；2026-02 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a002b40c-097d-47a5-957f-7a7b1807af7f", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": null, "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=enbrel-204.jpg&setid=a002b40c-097d-47a5-957f-7a7b1807af7f&type=img", "alt": "ENBREL 50 mg/mL 依那西普在美国 DailyMed 公开标签中的 Amgen 4 支单剂量 SureClick 预充式自动注射器包装面板", "archiveMarket": "美国", "labelVersion": "DailyMed 公开标签（Immunex Corporation，2026-02 更新）", "presentation": "ENBREL 50 mg/mL、4 支单剂量 SureClick 预充式自动注射器包装面板（NDC 58406-032-04；DailyMed 公开标签所列；Amgen 包装面板）。", "notice": "此为美国 DailyMed 公开标签中明确对应 ENBREL 50 mg/mL、4 支单剂量 SureClick 预充式自动注射器（NDC 58406-032-04）的 Amgen 包装面板，只帮助核对品牌、通用名、标示强度、皮下注射、装置、包装数量和来源；不用于鉴定真伪，也不证明预充式注射器、单剂量瓶、复溶多剂量瓶、Enbrel Mini 药筒、其他包装、其他市场标签、当前包装、原研/生物类似药关系、目标市场批准或可售资格。", "source": { "id": "src_07d76dde4eb09e52", "label": "DailyMed（NLM）：ENBREL 公开标签（Immunex Corporation，2026-02 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=a002b40c-097d-47a5-957f-7a7b1807af7f", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "ENBREL 说明书放大阅读：50 mg/mL、装置与包装数量必须一起核对", "en": "ENBREL label reading: 50 mg/mL, device and pack count must be checked together" }, "summary": { "zh": "本模块以 Immunex Corporation 的 DailyMed 2026-02 美国公开标签为阅读入口，严格对应 ENBREL（依那西普）50 mg/mL、4 支单剂量 SureClick 预充式自动注射器（NDC 58406-032-04）。它帮助阅读包装上的通用名、强度、装置、包装数量和目标市场；不提供个人注射次数、补用、转换、联用或储存操作方案。", "en": "This module uses Immunex Corporation's February 2026 U.S. DailyMed public label as a reading entry point. It is limited to ENBREL (etanercept) 50 mg/mL, four single-dose SureClick prefilled autoinjectors (NDC 58406-032-04). It helps read the package's generic name, strength, device, pack count and target market; it does not provide an individual's injection count, make-up, switch, combination or storage plan." }, "checks": [ { "zh": "本页图示的“50 mg/mL”“4 支单剂量预充式自动注射器”和 NDC 58406-032-04 是同一美国包装的身份线索。50 mg/mL 既涉及药物量也涉及体积；4 支是包装数量。它们不能单独或合起来换算为个人该注射几次、何时补用或是否能把两件产品合并。", "en": "For this one U.S. pack, “50 mg/mL,” “four single-dose prefilled autoinjectors,” and NDC 58406-032-04 are identity clues. 50 mg/mL involves both amount and volume; four is a pack count. Neither alone nor together can calculate an individual's injection count, make-up timing or whether two products may be combined." }, { "zh": "同一标签另列预充式注射器、单剂量瓶、复溶多剂量瓶和仅配合 AutoTouch 可重复使用自动注射器的 Enbrel Mini 药筒。共享“ENBREL/依那西普”、相同总 mg 或相似照片，都不能证明装置、操作、包装或个体使用可自行互换。", "en": "The same label separately lists a prefilled syringe, single-dose vial, reconstituted multiple-dose vial, and an Enbrel Mini cartridge only for the AutoTouch reusable autoinjector. Sharing “ENBREL/etanercept,” a total mg number or a similar photo does not prove devices, handling, packs or individual use can be self-interchanged." }, { "zh": "标签将此产品列为皮下注射用；这不是从网页学习注射、复溶、转移装置、分装或改变给药途径的授权。对实际装置、标签或使用步骤不确定时，应带上药盒向药师、注射培训人员或开方团队核对。", "en": "The label identifies this product for subcutaneous use; that is not permission to learn injection, reconstitution, device transfer, division or route changes from a webpage. With uncertainty about the actual device, label or use steps, bring the package to a pharmacist, injection-training professional or prescribing team." }, { "zh": "ENBREL 标签含严重感染等重要警示，并涉及免疫系统相关风险。正在使用另一种生物制品、免疫抑制剂、疫苗或多种慢病药，或出现发热、感染相关症状等新问题时，应及时让专业人员核对完整药单与实际包装；不要自行叠加、轮换、暂停或更换。", "en": "The ENBREL label carries important warnings including serious infections and immune-system-related risks. With another biologic, immunosuppressant, vaccine or several chronic-care medicines, or with a new concern such as fever or symptoms related to infection, have professionals promptly review the full medicine list and actual packages; do not self-combine, alternate, pause or switch." } ], "source": { "id": "src_07d76dde4eb09e52", "label": "DailyMed（NLM）：ENBREL 公开标签（Immunex Corporation，2026-02 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=a002b40c-097d-47a5-957f-7a7b1807af7f", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "依那西普怎样起作用：它以可溶性 TNF 受体形式阻断 TNF-α 与 TNF-β 的受体结合", "en": "How etanercept works: it is a soluble TNF-receptor form that blocks receptor binding by TNF-alpha and TNF-beta" }, "summary": { "zh": "DailyMed 的 ENBREL 标签说明，依那西普是 p75 TNF 受体的二聚体可溶性形式，可结合 TNF；它抑制 TNF-α 和 TNF-β（淋巴毒素 α）与细胞表面 TNF 受体结合，使 TNF 在该意义上失去生物学活性。该机制用于理解产品类别，不预测个人效果，也不决定注射数量、是否联用、转换或暂停。", "en": "The ENBREL DailyMed label explains that etanercept is a dimeric soluble form of the p75 TNF receptor that can bind TNF. It inhibits TNF-alpha and TNF-beta (lymphotoxin alpha) from binding cell-surface TNF receptors, rendering TNF biologically inactive in that sense. This explains a product class; it does not predict an individual outcome or decide injection count, combination, switching or pausing." }, "checks": [ { "zh": "“TNF 阻断”是药理机制词，不是判断任何关节、皮肤、肠道或其他症状原因的工具，更不构成自行开始、加量、补用或改变注射频率的理由。适用性必须基于准确产品的现行标签、诊疗资料和开方团队。", "en": "“TNF blockade” is a pharmacology term, not a tool for diagnosing the cause of any joint, skin, bowel or other symptom, and it is not a reason to self-start, increase, make up or change injection frequency. Suitability needs the current label for the exact product, clinical information and the prescribing team." }, { "zh": "与其他作用于 TNF 或免疫系统的产品有相近机制，不代表可自行同时使用、轮换或由一种产品换到另一种。生物制品的品牌、通用名、装置、规格、目标市场、感染筛查、疫苗与完整药单都需要专业人员逐项复核。", "en": "Having a related effect on TNF or the immune system does not make products self-combinable, alternatable or switchable. Biologic brand, generic name, device, strength, target market, infection screening, vaccines and the complete medicine list all need item-by-item professional review." }, { "zh": "机制也不能排除感染或其他严重不适，不能用来决定是否自行暂停任何免疫相关药物。出现发热、明显感染征象、呼吸困难、严重过敏样反应或其他急性问题，应优先使用当地医疗支持。", "en": "Mechanism cannot exclude an infection or another serious problem and cannot decide whether to self-pause any immune-related medicine. With fever, clear signs of infection, breathing difficulty, a severe allergy-like reaction or another acute concern, prioritise local medical support." } ], "source": { "id": "src_07d76dde4eb09e52", "label": "DailyMed（NLM）：ENBREL 公开标签（Immunex Corporation，2026-02 更新；Clinical Pharmacology）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=a002b40c-097d-47a5-957f-7a7b1807af7f", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "Enbrel", "generic": "依那西普", "dosageFormClass": "皮下注射：50 mg/mL 单剂量 SureClick 预充式自动注射器（本页包装图特定展示）" }, "labelSource": { "id": "src_07d76dde4eb09e52", "label": "DailyMed（NLM）：ENBREL 公开标签（Immunex Corporation，2026-02 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=a002b40c-097d-47a5-957f-7a7b1807af7f", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "productRoutes": [ { "source": { "id": "src_07d76dde4eb09e52", "label": "DailyMed（NLM）：ENBREL 公开标签（Immunex Corporation，2026-02 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=a002b40c-097d-47a5-957f-7a7b1807af7f", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_dd048abfe0b83733", "label": "FDA：ENBREL 2012 美国标签档案（BLA 103795）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/103795s5507lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "DailyMed 的 Immunex Corporation ENBREL（etanercept）公开标签列示其为皮下注射用产品，并列出美国初始批准年份为 1998。本页包装图严格对应 50 mg/mL、4 支单剂量 SureClick 预充式自动注射器（NDC 58406-032-04）；该记录不把这一包装延伸为其他装置、其他规格、其他市场批准、原研关系、供应、价格或可售资格结论。", "history": "同一 ENBREL 标签还列有预充式注射器、单剂量瓶、复溶多剂量瓶及仅与 AutoTouch 可重复使用自动注射器配套的 Mini 预充式药筒等不同呈现。共同通用名、相同总 mg 或相似外形不足以证明装置、制剂、包装或个体使用可互换；需按准确市场、包装和现行标签逐项核验。", "sourceDocuments": [ { "id": "src_07d76dde4eb09e52", "label": "DailyMed（NLM）：ENBREL 公开标签（Immunex Corporation，2026-02 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=a002b40c-097d-47a5-957f-7a7b1807af7f", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_dd048abfe0b83733", "label": "FDA：ENBREL 2012 美国标签档案（BLA 103795）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/103795s5507lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_5ed30b676fbb9773", "label": "FDA Drugs@FDA 官方检索入口", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_lookup_entry", "documentKind": "regulatory_lookup", "market": "US", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } ], "applicationNumber": "BLA 103795", "approvalTimeline": [ { "date": "1998", "title": { "zh": "FDA 标签所列美国初始批准年份", "en": "Initial U.S. approval year listed in the FDA label" }, "detail": { "zh": "本页链接的 FDA 标签档案列示 Initial U.S. Approval: 1998。该历史定位不等同于当前批准、可得性、持有人或其他市场状态。", "en": "The FDA label archive linked here lists Initial U.S. Approval: 1998. This historical locator is not a conclusion about current approval, availability, holder or another market." }, "source": { "id": "src_dd048abfe0b83733", "label": "FDA: Enbrel label archive", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/103795s5507lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, { "date": "2012", "title": { "zh": "FDA 标签档案版本", "en": "FDA label archive version" }, "detail": { "zh": "本页链接 2012 的 FDA 标签档案作为可复核阅读入口。现行标签、规格、适应症和安全信息必须另行以目标市场当前文件核对。", "en": "This page links the 2012 FDA label archive as a traceable reading entry point. Current labeling, strength, indication and safety information require separate verification against the target market’s current document." }, "source": { "id": "src_dd048abfe0b83733", "label": "FDA: Enbrel label archive", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/103795s5507lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "已链接公开标签档案", "en": "Public label archive linked" }, "detail": { "zh": "仅对应本页所列 FDA 文件。", "en": "Only the FDA document listed on this page is linked." } }, { "market": { "zh": "中国大陆、欧盟、日本", "en": "Mainland China, EU, Japan" }, "status": { "zh": "待逐项建立市场记录", "en": "Market record not established" }, "detail": { "zh": "不从美国标签档案推定当地批准、持有人、规格、供应或可售资格。", "en": "No local approval, holder, strength, supply or sale-eligibility conclusion is inferred from the U.S. label archive." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "标签档案能代表现在的产品信息吗？", "en": "Does a label archive represent current product information?" }, "answer": { "zh": "不能自动代表。档案用于定位来源；需要以目标市场的现行官方标签逐项复核。", "en": "Not automatically. The archive locates a source; each point needs verification against the target market’s current official label." } }, { "question": { "zh": "为什么这里不展示价格或原研/仿制结论？", "en": "Why are price and originator/generic conclusions not shown?" }, "answer": { "zh": "这些结论需要产品、剂型、规格、包装、市场、日期和原始记录分别齐全并经人工审核；单一标签文件不足以支持。", "en": "Those conclusions require separately complete and human-reviewed product, dosage-form, strength, pack, market, date and primary-record fields; one label file is insufficient." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "dosage-forms-are-part-of-medicine-identity", "medicine-label-for-everyday-questions", "how-to-read-a-drug-label" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/enbrel/", "en": "https://origindrug.com/en/drugs/enbrel/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "remicade", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-28", "status": "published_traceable_archive" }, "names": { "brand": "Remicade", "generic": "英夫利昔单抗", "aliases": [ "infliximab" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "免疫", "sourceArchiveMarket": "美国 DailyMed 当前公开标签（2025-06 更新；100 mg 单剂量冻干粉瓶）", "dosageFormClass": "静脉输注用冻干粉：每瓶英夫利昔单抗 100 mg，单剂量瓶", "dosageFormClassCode": "intravenous_infusion", "route": "静脉输注", "routeCode": "intravenous", "historicalApprovalEntry": "1998（美国公开标签所列初始批准）", "archiveSponsorText": "Janssen Biotech / DailyMed（NLM）美国公开标签" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-remicade-infliximab-100mg-single-dose-vial-ndc-57894-030-01", "marketCode": "US", "labelVersion": { "zh": "DailyMed 美国公开标签（Janssen Biotech；2025-06 更新）", "en": "DailyMed U.S. public label (Janssen Biotech; updated Jun 2025)" }, "dosageForm": { "zh": "REMICADE 英夫利昔单抗静脉输注用冻干粉", "en": "REMICADE infliximab lyophilised powder for intravenous infusion" }, "route": { "zh": "复溶并稀释后静脉输注（仅为标签产品身份；不是操作指令）", "en": "intravenous infusion after reconstitution and dilution (label identity only; not a procedure instruction)" }, "routeCodes": [ "intravenous_infusion" ], "productCode": "NDC 57894-030-01", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_single_dose_vial", "primaryDisplay": { "zh": "每个单剂量瓶含英夫利昔单抗 100 mg 白色冻干粉；每盒 1 瓶", "en": "Infliximab 100 mg white lyophilised powder per single-dose vial; one vial per carton" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=Remicade_Carton_10378704.jpg&setid=a0a046c1-056d-45a9-bfd9-13b47c24f257&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "英夫利昔单抗", "en": "infliximab" }, "value": 100, "unit": "mg", "basisCode": "per_single_dose_vial", "basisLabel": { "zh": "每个单剂量瓶的标签总量；不是个人输注量、瓶数、复溶或稀释方案", "en": "labelled total per single-dose vial; not an individual's infusion amount, vial count, reconstitution or dilution plan" } } ], "concentration": null, "container": { "typeCode": "single_dose_vial_lyophilised_powder", "typeLabel": { "zh": "无菌、无防腐剂白色冻干粉单剂量瓶", "en": "sterile, preservative-free white lyophilised-powder single-dose vial" }, "fill": null, "countPerPackage": null, "countUnit": null }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-28", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 1, "unit": { "zh": "个单剂量瓶/盒", "en": "single-dose vial per carton" } }, "physicalClues": { "color": { "zh": "白色冻干粉（标签描述）", "en": "white lyophilised powder (label description)" }, "shape": { "zh": "100 mg 单剂量玻璃瓶及纸盒", "en": "100 mg single-dose glass vial and carton" }, "imprint": null, "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_18008f0c9aabed80", "label": "DailyMed（NLM）：REMICADE 100 mg 单剂量冻干粉瓶美国公开标签面板（Janssen Biotech；2025-06 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a0a046c1-056d-45a9-bfd9-13b47c24f257", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-remicade-infliximab-100mg-single-dose-vial-ndc-57894-030-01", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=Remicade_Carton_10378704.jpg&setid=a0a046c1-056d-45a9-bfd9-13b47c24f257&type=img", "alt": "REMICADE 英夫利昔单抗在美国 DailyMed Janssen Biotech 公开标签中的 100 mg 单剂量瓶纸盒展开图", "archiveMarket": "美国", "labelVersion": "DailyMed 公开标签（Janssen Biotech，2025-06 更新）", "presentation": "REMICADE 注射用冻干粉：每瓶英夫利昔单抗 100 mg，单剂量瓶纸盒展开图（DailyMed Janssen Biotech 公开标签所列）。", "notice": "此为美国 DailyMed Janssen Biotech 公开标签中明确对应 REMICADE、英夫利昔单抗 100 mg 单剂量瓶的纸盒展开图，只帮助核对品牌、通用名、剂型、标示强度、单剂量瓶和来源；不用于鉴定真伪，也不证明其他规格、其他给药形式、其他市场标签、当前可得性、原研身份、目标市场批准或可售资格。", "source": { "id": "src_a04dececdf95e1a0", "label": "DailyMed（NLM）：REMICADE 公开标签（Janssen Biotech，2025-06 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=a0a046c1-056d-45a9-bfd9-13b47c24f257", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "REMICADE 说明书放大阅读：100 mg 单剂量瓶是输注产品身份，不是居家用量", "en": "REMICADE label reading: a 100 mg single-dose vial identifies an infusion product, not an at-home amount" }, "summary": { "zh": "以 DailyMed 当前 REMICADE 美国公开标签为阅读入口，核对英夫利昔单抗、100 mg 单剂量冻干粉瓶、静脉输注制剂和目标市场；不把瓶身数字、配制文字或疾病名称变成个人剂量、家庭操作、停药或联合方案。", "en": "Using the current U.S. DailyMed public label for REMICADE as an entry point, this checks infliximab, a 100 mg single-dose lyophilised vial, intravenous infusion and target market; it does not turn vial markings, preparation text or a disease name into an individual dose, home handling, stopping or combination plan." }, "checks": [ { "zh": "100 mg 是这一个单剂量瓶的产品身份线索，不是自己该用几瓶、能否留存余量、分装或在家配制的答案。复溶、稀释、输注、监测和剩余处置应由治疗机构按现行标签和处方完成。", "en": "100 mg is a product-identity clue for this single-dose vial, not an answer to vial count, saving leftovers, sharing or preparing it at home. Reconstitution, dilution, infusion, monitoring and remaining-product handling belong to the treatment facility under the current label and prescription." }, { "zh": "同为 TNF 相关治疗、免疫调节药或静脉用药，不表示可与其他生物制剂、免疫抑制剂、激素、疫苗或感染治疗自行叠加、轮换或替代。", "en": "Being a TNF-related treatment, immune-modifying medicine or intravenous product does not permit self-combination, alternation or substitution with another biologic, immunosuppressant, steroid, vaccine or infection treatment." }, { "zh": "发热、持续咳嗽、呼吸不适、严重腹痛、异常出血、明显无力、神经变化或其他急性问题，应及时联系治疗团队或使用当地紧急医疗支持。", "en": "With fever, persistent cough, breathing trouble, severe abdominal pain, unusual bleeding, marked weakness, neurologic change or another acute concern, contact the treatment team promptly or use local urgent medical support." } ], "source": { "id": "src_18008f0c9aabed80", "label": "DailyMed（NLM）：REMICADE 当前美国公开标签", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a0a046c1-056d-45a9-bfd9-13b47c24f257", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "英夫利昔单抗怎样起作用：标签描述其结合并中和 TNFα 的功能", "en": "How infliximab works: the label describes binding and neutralising TNF-alpha activity" }, "summary": { "zh": "FDA 的 REMICADE 标签描述英夫利昔单抗可结合 TNFα 的可溶性和跨膜形式，并抑制其功能活性。TNFα 参与炎症和免疫反应；这解释一条免疫信号路径，不诊断炎症性疾病，也不决定个人是否适用、输注频率、合用药物或是否应转换治疗。", "en": "The FDA REMICADE label describes infliximab as binding soluble and transmembrane TNF-alpha and inhibiting its functional activity. TNF-alpha participates in inflammatory and immune responses; this explains one immune-signalling pathway, not diagnosis of inflammatory disease or individual suitability, infusion frequency, co-medication or whether to switch treatment." }, "checks": [ { "zh": "“抗 TNF”不等于所有炎症、关节痛、腹痛、皮疹或肠道症状都适合英夫利昔单抗，更不能从机制页面决定开始、延迟、停用、补用或改变输注间隔。", "en": "“Anti-TNF” does not mean every inflammatory concern, joint pain, abdominal symptom, rash or bowel symptom is suitable for infliximab, and a mechanism page cannot decide starting, delaying, stopping, redosing or changing an infusion interval." }, { "zh": "同属抗 TNF 类、都有生物制剂字样或曾对另一种产品有效/无效，都不表示可以自行叠加、轮换或替代。产品、疾病评估、感染筛查、输注设置、完整药单和现行标签必须由专科团队核对。", "en": "Being in an anti-TNF class, carrying a biologic label or having response/non-response to another product does not permit self-combination, alternation or substitution. Product, disease assessment, infection screening, infusion setting, complete medicine list and current label require specialist review." }, { "zh": "标签包含严重感染、输注反应及其他警示。发热、持续咳嗽、呼吸困难、严重皮疹、晕厥或其他急性不适时，应及时使用当地医疗支持，而不是从机制推导下一次输注或联用安排。", "en": "The label includes warnings about serious infection, infusion reactions and other risks. With fever, persistent cough, breathing trouble, severe rash, fainting or another acute concern, use timely local medical support rather than deriving the next infusion or combination plan from mechanism." } ], "source": { "id": "src_18008f0c9aabed80", "label": "DailyMed（NLM）：REMICADE 当前美国公开标签（临床药理）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a0a046c1-056d-45a9-bfd9-13b47c24f257", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "Remicade", "generic": "英夫利昔单抗", "dosageFormClass": "静脉输注用冻干粉：每瓶英夫利昔单抗 100 mg，单剂量瓶" }, "labelSource": { "id": "src_18008f0c9aabed80", "label": "DailyMed（NLM）：REMICADE 英夫利昔单抗当前美国公开标签（Janssen Biotech；2025-06 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a0a046c1-056d-45a9-bfd9-13b47c24f257", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "productRoutes": [ { "source": { "id": "src_18008f0c9aabed80", "label": "DailyMed（NLM）：REMICADE 英夫利昔单抗当前美国公开标签（Janssen Biotech；2025-06 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a0a046c1-056d-45a9-bfd9-13b47c24f257", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_b100135e17c1fbea", "label": "FDA：REMICADE 2017 美国历史标签（BLA 103772）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/103772s5377lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "DailyMed 的 REMICADE（infliximab）当前美国公开标签列示每瓶 100 mg 的静脉输注用冻干粉单剂量瓶。本页把商品名、通用名、每瓶标示量、NDC、包装图和来源对应；不把 100 mg 变成个人输注量、瓶数、配制、间隔、换药或购买结论。", "history": "静脉输注生物制品必须按准确制剂、单剂量瓶、标示强度、配制要求、市场与现行标签核对；包装图不构成真实性、互换性或个人适用性结论。", "sourceDocuments": [ { "id": "src_18008f0c9aabed80", "label": "DailyMed（NLM）：REMICADE 英夫利昔单抗当前美国公开标签（Janssen Biotech；2025-06 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a0a046c1-056d-45a9-bfd9-13b47c24f257", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_b100135e17c1fbea", "label": "FDA：REMICADE 2017 美国历史标签（BLA 103772）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/103772s5377lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_5ed30b676fbb9773", "label": "FDA Drugs@FDA 官方检索入口", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_lookup_entry", "documentKind": "regulatory_lookup", "market": "US", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } ], "applicationNumber": "BLA 103772", "approvalTimeline": [ { "date": "DailyMed 当前公开标签，2025-06 更新", "title": { "zh": "当前美国公开标签的日期记录", "en": "Dated current U.S. public-label record" }, "detail": { "zh": "本页链接 DailyMed 当前公开标签，2025-06 更新 的当前美国公开标签，作为放大阅读和逐项核对入口。它不替代目标市场当日的批准、供应、适应症、规格或个体化用药判断。", "en": "This page links the current U.S. public label dated DailyMed 当前公开标签，2025-06 更新 as an enlarged-reading and item-by-item checking entry point. It does not replace same-day verification of approval, supply, indication, strength or individual use in the target market." }, "source": { "id": "src_18008f0c9aabed80", "label": "DailyMed: current REMICADE U.S. public label", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a0a046c1-056d-45a9-bfd9-13b47c24f257", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "已链接当前公开标签", "en": "Current public label linked" }, "detail": { "zh": "仅对应本页所列的美国公开标签；不据此推定库存、可售资格或其他市场状态。", "en": "Only the U.S. public label listed on this page is linked; no stock, sale-eligibility or other-market conclusion is inferred." } }, { "market": { "zh": "中国大陆、欧盟、日本", "en": "Mainland China, EU, Japan" }, "status": { "zh": "待逐项建立市场记录", "en": "Market record not established" }, "detail": { "zh": "不从美国公开标签推定当地批准、持有人、规格、供应或可售资格。", "en": "No local approval, holder, strength, supply or sale-eligibility conclusion is inferred from the U.S. public label." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "当前美国标签能代表其他国家或地区吗？", "en": "Does a current U.S. label represent another country or region?" }, "answer": { "zh": "不能。它是逐项阅读入口；品牌、剂型、规格、可得性和安全信息仍须以目标市场的现行官方文件核对。", "en": "No. It is an item-by-item reading entry point; brand, dosage form, strength, availability and safety information still require checking against the target market's current official document." } }, { "question": { "zh": "为什么这里不展示价格或原研/仿制结论？", "en": "Why are price and originator/generic conclusions not shown?" }, "answer": { "zh": "这些结论需要产品、剂型、规格、包装、市场、日期和原始记录分别齐全并经人工审核；单一标签文件不足以支持。", "en": "Those conclusions require separately complete and human-reviewed product, dosage-form, strength, pack, market, date and primary-record fields; one label file is insufficient." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "dosage-forms-are-part-of-medicine-identity", "medicine-label-for-everyday-questions", "how-to-read-a-drug-label" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/remicade/", "en": "https://origindrug.com/en/drugs/remicade/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "stelara", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-28", "status": "published_traceable_archive" }, "names": { "brand": "Stelara", "generic": "乌司奴单抗", "aliases": [ "ustekinumab" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "免疫", "sourceArchiveMarket": "美国 DailyMed 当前公开标签（2026-07 更新；四个准确皮下/静脉包装身份）", "dosageFormClass": "皮下注射：45 mg/0.5 mL 单剂量瓶、45 mg/0.5 mL 与 90 mg/mL 预充式注射器；静脉输注：130 mg/26 mL 单剂量瓶", "dosageFormClassCode": "subcutaneous_injection", "route": "皮下 / 静脉输注", "routeCode": "subcutaneous", "historicalApprovalEntry": "2009（美国公开标签所列初始批准）", "archiveSponsorText": "Janssen Biotech / DailyMed（NLM）美国公开标签" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-stelara-ustekinumab-45mg-0-5ml-single-dose-vial-subcutaneous-5789406002", "marketCode": "US", "labelVersion": { "zh": "DailyMed 美国公开标签（Janssen Biotech；2026-07 更新）", "en": "DailyMed U.S. public label (Janssen Biotech; updated Jul 2026)" }, "dosageForm": { "zh": "STELARA 乌司奴单抗单剂量瓶", "en": "STELARA ustekinumab single-dose vial" }, "route": { "zh": "皮下注射（标签产品身份字段）", "en": "subcutaneous injection (label product-identity field)" }, "routeCodes": [ "subcutaneous_injection" ], "productCode": "NDC 57894-060-02", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_single_dose_vial", "primaryDisplay": { "zh": "每个单剂量瓶含乌司奴单抗 45 mg/0.5 mL；每盒 1 个", "en": "Ustekinumab 45 mg/0.5 mL per single-dose vial; one per carton" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=stelara-20.jpg&setid=c77a9664-e3bb-4023-b400-127aa53bca2b&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "乌司奴单抗", "en": "ustekinumab" }, "value": 45, "unit": "mg", "basisCode": "per_single_dose_vial", "basisLabel": { "zh": "每个单剂量瓶的标签总量；不是个人注射/输注量、频次、转换或换药方案", "en": "labelled total per single-dose vial; not an individual's injection/infusion amount, frequency, conversion or switching plan" } } ], "concentration": null, "container": { "typeCode": "single_dose_vial_subcutaneous", "typeLabel": { "zh": "皮下注射用单剂量玻璃瓶", "en": "single-dose glass vial for subcutaneous injection" }, "fill": { "value": 0.5, "unit": "mL" }, "countPerPackage": null, "countUnit": null }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-28", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 1, "unit": { "zh": "个单剂量瓶/盒", "en": "single-dose vial per carton" } }, "physicalClues": { "color": { "zh": "无色至淡黄色溶液，可见少量半透明或白色小颗粒（标签描述）", "en": "colourless to light-yellow solution that may contain a few small translucent or white particles (label description)" }, "shape": { "zh": "单剂量瓶及独立纸盒", "en": "individually packaged single-dose vial and carton" }, "imprint": null, "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_19dc277142d47a4d", "label": "DailyMed（NLM）：STELARA 45 mg/0.5 mL 单剂量瓶美国公开标签面板（Janssen Biotech；2026-07 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c77a9664-e3bb-4023-b400-127aa53bca2b", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-stelara-ustekinumab-45mg-0-5ml-prefilled-syringe-5789406003", "marketCode": "US", "labelVersion": { "zh": "DailyMed 美国公开标签（Janssen Biotech；2026-07 更新）", "en": "DailyMed U.S. public label (Janssen Biotech; updated Jul 2026)" }, "dosageForm": { "zh": "STELARA 乌司奴单抗单剂量预充式注射器", "en": "STELARA ustekinumab single-dose prefilled syringe" }, "route": { "zh": "皮下注射（标签产品身份字段）", "en": "subcutaneous injection (label product-identity field)" }, "routeCodes": [ "subcutaneous_injection" ], "productCode": "NDC 57894-060-03", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_single_dose_prefilled_syringe", "primaryDisplay": { "zh": "每个单剂量预充式注射器含乌司奴单抗 45 mg/0.5 mL；每盒 1 个", "en": "Ustekinumab 45 mg/0.5 mL per single-dose prefilled syringe; one per carton" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=45mg+PFS+CArton.jpg&setid=c77a9664-e3bb-4023-b400-127aa53bca2b&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "乌司奴单抗", "en": "ustekinumab" }, "value": 45, "unit": "mg", "basisCode": "per_single_dose_prefilled_syringe", "basisLabel": { "zh": "每个单剂量预充式注射器的标签总量；不是个人注射/输注量、频次、转换或换药方案", "en": "labelled total per single-dose prefilled syringe; not an individual's injection/infusion amount, frequency, conversion or switching plan" } } ], "concentration": null, "container": { "typeCode": "single_dose_prefilled_syringe", "typeLabel": { "zh": "带 27G、1/2 英寸固定针和安全护套的单剂量预充式注射器", "en": "single-dose prefilled syringe with fixed 27-gauge, 1/2-inch needle and safety guard" }, "fill": { "value": 0.5, "unit": "mL" }, "countPerPackage": null, "countUnit": null }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-28", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 1, "unit": { "zh": "个单剂量预充式注射器/盒", "en": "single-dose prefilled syringe per carton" } }, "physicalClues": { "color": { "zh": "无色至淡黄色溶液，可见少量半透明或白色小颗粒（标签描述）", "en": "colourless to light-yellow solution that may contain a few small translucent or white particles (label description)" }, "shape": { "zh": "单剂量预充式注射器及独立纸盒", "en": "individually packaged single-dose prefilled syringe and carton" }, "imprint": null, "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_19dc277142d47a4d", "label": "DailyMed（NLM）：STELARA 45 mg/0.5 mL 单剂量预充式注射器美国公开标签面板（Janssen Biotech；2026-07 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c77a9664-e3bb-4023-b400-127aa53bca2b", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-stelara-ustekinumab-90mg-1ml-prefilled-syringe-5789406103", "marketCode": "US", "labelVersion": { "zh": "DailyMed 美国公开标签（Janssen Biotech；2026-07 更新）", "en": "DailyMed U.S. public label (Janssen Biotech; updated Jul 2026)" }, "dosageForm": { "zh": "STELARA 乌司奴单抗单剂量预充式注射器", "en": "STELARA ustekinumab single-dose prefilled syringe" }, "route": { "zh": "皮下注射（标签产品身份字段）", "en": "subcutaneous injection (label product-identity field)" }, "routeCodes": [ "subcutaneous_injection" ], "productCode": "NDC 57894-061-03", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_single_dose_prefilled_syringe", "primaryDisplay": { "zh": "每个单剂量预充式注射器含乌司奴单抗 90 mg/1 mL；每盒 1 个", "en": "Ustekinumab 90 mg/1 mL per single-dose prefilled syringe; one per carton" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=90mg+PFS+Carton.jpg&setid=c77a9664-e3bb-4023-b400-127aa53bca2b&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "乌司奴单抗", "en": "ustekinumab" }, "value": 90, "unit": "mg", "basisCode": "per_single_dose_prefilled_syringe", "basisLabel": { "zh": "每个单剂量预充式注射器的标签总量；不是个人注射/输注量、频次、转换或换药方案", "en": "labelled total per single-dose prefilled syringe; not an individual's injection/infusion amount, frequency, conversion or switching plan" } } ], "concentration": null, "container": { "typeCode": "single_dose_prefilled_syringe", "typeLabel": { "zh": "带 27G、1/2 英寸固定针和安全护套的单剂量预充式注射器", "en": "single-dose prefilled syringe with fixed 27-gauge, 1/2-inch needle and safety guard" }, "fill": { "value": 1, "unit": "mL" }, "countPerPackage": null, "countUnit": null }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-28", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 1, "unit": { "zh": "个单剂量预充式注射器/盒", "en": "single-dose prefilled syringe per carton" } }, "physicalClues": { "color": { "zh": "无色至淡黄色溶液，可见少量半透明或白色小颗粒（标签描述）", "en": "colourless to light-yellow solution that may contain a few small translucent or white particles (label description)" }, "shape": { "zh": "单剂量预充式注射器及独立纸盒", "en": "individually packaged single-dose prefilled syringe and carton" }, "imprint": null, "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_19dc277142d47a4d", "label": "DailyMed（NLM）：STELARA 90 mg/1 mL 单剂量预充式注射器美国公开标签面板（Janssen Biotech；2026-07 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c77a9664-e3bb-4023-b400-127aa53bca2b", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-stelara-ustekinumab-130mg-26ml-single-dose-vial-intravenous-5789405427", "marketCode": "US", "labelVersion": { "zh": "DailyMed 美国公开标签（Janssen Biotech；2026-07 更新）", "en": "DailyMed U.S. public label (Janssen Biotech; updated Jul 2026)" }, "dosageForm": { "zh": "STELARA 乌司奴单抗单剂量瓶", "en": "STELARA ustekinumab single-dose vial" }, "route": { "zh": "稀释后静脉输注（仅为标签产品身份；不是操作指令）", "en": "intravenous infusion after dilution (label identity only; not a procedure instruction)" }, "routeCodes": [ "intravenous_infusion" ], "productCode": "NDC 57894-054-27", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_single_dose_vial", "primaryDisplay": { "zh": "每个单剂量瓶含乌司奴单抗 130 mg/26 mL（5 mg/mL）；每盒 1 个", "en": "Ustekinumab 130 mg/26 mL (5 mg/mL) per single-dose vial; one per carton" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=130mg+vial+carton+%281%29.jpg&setid=c77a9664-e3bb-4023-b400-127aa53bca2b&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "乌司奴单抗", "en": "ustekinumab" }, "value": 130, "unit": "mg", "basisCode": "per_single_dose_vial", "basisLabel": { "zh": "每个单剂量瓶的标签总量；不是个人注射/输注量、频次、转换或换药方案", "en": "labelled total per single-dose vial; not an individual's injection/infusion amount, frequency, conversion or switching plan" } } ], "concentration": null, "container": { "typeCode": "single_dose_vial", "typeLabel": { "zh": "静脉输注用单剂量瓶", "en": "single-dose vial for intravenous infusion" }, "fill": { "value": 26, "unit": "mL" }, "countPerPackage": null, "countUnit": null }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-28", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 1, "unit": { "zh": "个单剂量瓶/盒", "en": "single-dose vial per carton" } }, "physicalClues": { "color": { "zh": "无色至淡黄色溶液，可见少量半透明或白色小颗粒（标签描述）", "en": "colourless to light-yellow solution that may contain a few small translucent or white particles (label description)" }, "shape": { "zh": "单剂量瓶及独立纸盒", "en": "individually packaged single-dose vial and carton" }, "imprint": null, "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_19dc277142d47a4d", "label": "DailyMed（NLM）：STELARA 130 mg/26 mL 单剂量瓶美国公开标签面板（Janssen Biotech；2026-07 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c77a9664-e3bb-4023-b400-127aa53bca2b", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-stelara-ustekinumab-130mg-26ml-single-dose-vial-intravenous-5789405427", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=130mg+vial+carton+%281%29.jpg&setid=c77a9664-e3bb-4023-b400-127aa53bca2b&type=img", "alt": "STELARA 乌司奴单抗在美国 DailyMed Janssen Biotech 公开标签中的 130 mg/26 mL 静脉输注单剂量瓶纸盒展开图", "archiveMarket": "美国", "labelVersion": "DailyMed 公开标签（Janssen Biotech，2026-07 更新）", "presentation": "STELARA 注射液：130 mg/26 mL（5 mg/mL），静脉输注用单剂量瓶纸盒展开图（DailyMed Janssen Biotech 公开标签所列）。", "notice": "此为美国 DailyMed Janssen Biotech 公开标签中明确对应 STELARA、乌司奴单抗 130 mg/26 mL（5 mg/mL）静脉输注用单剂量瓶的纸盒展开图，只帮助核对品牌、通用名、剂型、标示浓度、静脉输注用与来源；不用于鉴定真伪，也不证明皮下注射预充式注射器、其他规格、其他市场标签、当前可得性、原研身份、目标市场批准或可售资格。", "source": { "id": "src_4bdbc9d18f29966d", "label": "DailyMed（NLM）：STELARA 公开标签（Janssen Biotech，2026-07 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=c77a9664-e3bb-4023-b400-127aa53bca2b", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "STELARA 说明书放大阅读：静脉制剂和皮下制剂不能凭同名互推", "en": "STELARA label reading: intravenous and subcutaneous products cannot be inferred from a shared name" }, "summary": { "zh": "以 DailyMed 当前 STELARA 美国公开标签为阅读入口，核对乌司奴单抗、静脉或皮下给药途径、包装与目标市场；不把同名产品、毫克数字、输注或注射文字变成个人剂量、居家操作或转换方案。", "en": "Using the current U.S. DailyMed public label for STELARA as an entry point, this checks ustekinumab, intravenous or subcutaneous route, package and target market; it does not turn a shared name, mg marking, infusion or injection wording into an individual dose, home handling or conversion plan." }, "checks": [ { "zh": "标签所列 130 mg/26 mL（5 mg/mL）静脉用瓶是该准确静脉制剂的身份线索，并不证明皮下产品、另一市场包装或不同规格相同。", "en": "The label's 130 mg/26 mL (5 mg/mL) IV vial is an identity clue for that exact IV product; it does not establish that a subcutaneous product, another-market pack or another presentation is the same." }, { "zh": "同为免疫相关药、生物制剂或治疗相近疾病，不表示可与其他生物制剂、免疫抑制药、激素、疫苗或感染治疗自行组合、轮换或替代。", "en": "Being an immune-related medicine, biologic or treatment for a related disease does not permit self-combination, alternation or substitution with another biologic, immunosuppressant, steroid, vaccine or infection treatment." }, { "zh": "高热、呼吸困难、严重腹痛、异常神经症状、广泛皮疹或其他急性问题时，应及时联系当地治疗团队或紧急医疗支持。", "en": "With high fever, breathing trouble, severe abdominal pain, unusual neurologic symptoms, widespread rash or another acute concern, contact the local treatment team or urgent medical support promptly." } ], "source": { "id": "src_19dc277142d47a4d", "label": "DailyMed（NLM）：STELARA 当前美国公开标签", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c77a9664-e3bb-4023-b400-127aa53bca2b", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "乌司奴单抗怎样起作用：标签描述其结合 IL-12 与 IL-23 共用的 p40 亚基", "en": "How ustekinumab works: the label describes binding the p40 subunit shared by IL-12 and IL-23" }, "summary": { "zh": "FDA 的 STELARA 标签描述乌司奴单抗可特异性结合 IL-12 和 IL-23 共用的 p40 蛋白亚基，干扰这些细胞因子与共同受体链的相互作用。它解释免疫信号路径，不决定个人的诊断、是否适合使用、静脉诱导与皮下注射维持如何衔接、剂量或换药。", "en": "The FDA STELARA label describes ustekinumab as specifically binding the p40 protein subunit shared by IL-12 and IL-23, disrupting their interaction with a shared receptor chain. It explains an immune-signalling pathway, not an individual's diagnosis, suitability, how intravenous induction and subcutaneous maintenance are sequenced, dose or medicine switch." }, "checks": [ { "zh": "“IL-12/23”或“靶向炎症因子”不是自行判断皮肤、关节或肠道症状原因，或决定开始、停用、改期、加量或换药的工具。诊断、感染筛查、疾病活动度、完整药单和现行标签须由专科团队一并评估。", "en": "“IL-12/23” or “targets inflammatory cytokines” is not a tool for identifying the cause of skin, joint or bowel symptoms, or deciding start, stop, delay, dose change or switching. Diagnosis, infection screening, disease activity, complete medicine list and current label need specialist assessment together." }, { "zh": "皮下制剂、静脉制剂、其他乌司奴单抗产品或不同市场规格不能因共同机制自行换算、互换或叠加。给药途径、浓度、一次性输注安排和维持方案必须核对准确产品的现行标签。", "en": "Subcutaneous products, intravenous products, another ustekinumab product or a different-market strength cannot be self-converted, interchanged or combined because of a shared mechanism. Route, concentration, one-time infusion plan and maintenance plan must be checked against the current label for the exact product." }, { "zh": "标签含有感染、过敏和其他风险信息。发热、持续咳嗽、呼吸困难、全身皮疹、晕厥或其他急性严重不适时，应及时联系当地治疗团队或紧急医疗支持。", "en": "The label contains information about infection, allergy and other risks. With fever, persistent cough, breathing trouble, widespread rash, fainting or another acute severe concern, contact the local treatment team or urgent medical support promptly." } ], "source": { "id": "src_19dc277142d47a4d", "label": "DailyMed（NLM）：STELARA 当前美国公开标签（临床药理）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c77a9664-e3bb-4023-b400-127aa53bca2b", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "Stelara", "generic": "乌司奴单抗", "dosageFormClass": "皮下注射：45 mg/0.5 mL 单剂量瓶、45 mg/0.5 mL 与 90 mg/mL 预充式注射器；静脉输注：130 mg/26 mL 单剂量瓶" }, "labelSource": { "id": "src_19dc277142d47a4d", "label": "DailyMed（NLM）：STELARA 乌司奴单抗当前美国公开标签（Janssen Biotech；2026-07 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c77a9664-e3bb-4023-b400-127aa53bca2b", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "productRoutes": [ { "source": { "id": "src_19dc277142d47a4d", "label": "DailyMed（NLM）：STELARA 乌司奴单抗当前美国公开标签（Janssen Biotech；2026-07 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c77a9664-e3bb-4023-b400-127aa53bca2b", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_9368420c3c9534f8", "label": "FDA：STELARA 2016 美国历史标签（BLA 761044）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/761044lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "DailyMed 的 STELARA（ustekinumab）当前美国公开标签同时列示皮下注射与静脉输注包装。本页将四个准确包装的给药途径、容器、浓度/总体积、NDC 与来源分开呈现；共同商品名不能证明可自行换算、配制、注射、转换或替代。", "history": "皮下单剂量瓶、皮下预充式注射器与静脉单剂量瓶是不同产品身份；不能仅按通用名、商品名或照片建立等同性。具体标签版本、规格、市场状态和实际供应均须逐项核验。", "sourceDocuments": [ { "id": "src_19dc277142d47a4d", "label": "DailyMed（NLM）：STELARA 乌司奴单抗当前美国公开标签（Janssen Biotech；2026-07 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c77a9664-e3bb-4023-b400-127aa53bca2b", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_9368420c3c9534f8", "label": "FDA：STELARA 2016 美国历史标签（BLA 761044）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/761044lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_5ed30b676fbb9773", "label": "FDA Drugs@FDA 官方检索入口", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_lookup_entry", "documentKind": "regulatory_lookup", "market": "US", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } ], "applicationNumber": "BLA 761044", "approvalTimeline": [ { "date": "DailyMed SPL v22，2026-07 发布", "title": { "zh": "当前美国公开标签的日期记录", "en": "Dated current U.S. public-label record" }, "detail": { "zh": "本页链接 DailyMed SPL v22，2026-07 发布 的当前美国公开标签，作为放大阅读和逐项核对入口。它不替代目标市场当日的批准、供应、适应症、规格或个体化用药判断。", "en": "This page links the current U.S. public label dated DailyMed SPL v22，2026-07 发布 as an enlarged-reading and item-by-item checking entry point. It does not replace same-day verification of approval, supply, indication, strength or individual use in the target market." }, "source": { "id": "src_19dc277142d47a4d", "label": "DailyMed: current STELARA U.S. public label", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c77a9664-e3bb-4023-b400-127aa53bca2b", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "已链接当前公开标签", "en": "Current public label linked" }, "detail": { "zh": "仅对应本页所列的美国公开标签；不据此推定库存、可售资格或其他市场状态。", "en": "Only the U.S. public label listed on this page is linked; no stock, sale-eligibility or other-market conclusion is inferred." } }, { "market": { "zh": "中国大陆、欧盟、日本", "en": "Mainland China, EU, Japan" }, "status": { "zh": "待逐项建立市场记录", "en": "Market record not established" }, "detail": { "zh": "不从美国公开标签推定当地批准、持有人、规格、供应或可售资格。", "en": "No local approval, holder, strength, supply or sale-eligibility conclusion is inferred from the U.S. public label." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "当前美国标签能代表其他国家或地区吗？", "en": "Does a current U.S. label represent another country or region?" }, "answer": { "zh": "不能。它是逐项阅读入口；品牌、剂型、规格、可得性和安全信息仍须以目标市场的现行官方文件核对。", "en": "No. It is an item-by-item reading entry point; brand, dosage form, strength, availability and safety information still require checking against the target market's current official document." } }, { "question": { "zh": "为什么这里不展示价格或原研/仿制结论？", "en": "Why are price and originator/generic conclusions not shown?" }, "answer": { "zh": "这些结论需要产品、剂型、规格、包装、市场、日期和原始记录分别齐全并经人工审核；单一标签文件不足以支持。", "en": "Those conclusions require separately complete and human-reviewed product, dosage-form, strength, pack, market, date and primary-record fields; one label file is insufficient." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "dosage-forms-are-part-of-medicine-identity", "medicine-label-for-everyday-questions", "how-to-read-a-drug-label" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/stelara/", "en": "https://origindrug.com/en/drugs/stelara/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "dupixent", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-22", "status": "published_traceable_archive" }, "names": { "brand": "DUPIXENT", "generic": "度普利尤单抗", "aliases": [ "DUPIXENT", "dupilumab", "度普利尤单抗" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "免疫", "sourceArchiveMarket": "美国 DUPIXENT 当前公开标签（DailyMed 页面 2026-04-22 更新；本档案仅核对所列 300 mg/2 mL 双支预充式注射器纸盒）", "dosageFormClass": "皮下注射液：单剂量预充式注射器（带针头保护装置）；本档案只对应所列 300 mg/2 mL、2 支纸盒", "dosageFormClassCode": "subcutaneous_injection", "route": "皮下", "routeCode": "subcutaneous", "historicalApprovalEntry": "2017（FDA 标签所列 Initial U.S. Approval）", "archiveSponsorText": "Sanofi-aventis U.S. LLC / DailyMed（NLM）当前美国公开标签" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [ "DUPIXENT 预充式注射笔", "DUPIXENT 200 mg/1.14 mL", "dupilumab 200 mg/1.14 mL" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-dupixent-dupilumab-300mg-2ml-two-prefilled-syringes-ndc-0024-5914-01", "marketCode": "US", "labelVersion": { "zh": "DailyMed 美国公开标签（2026-04-22 更新）", "en": "U.S. DailyMed public label (updated 22 Apr 2026)" }, "dosageForm": { "zh": "皮下注射液：单剂量预充式注射器（带针头保护装置）", "en": "subcutaneous injection: single-dose pre-filled syringe with needle shield" }, "route": { "zh": "皮下（标签产品身份字段）", "en": "subcutaneous (label product-identity field)" }, "routeCodes": [ "subcutaneous" ], "productCode": "NDC 0024-5914-01", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_prefilled_syringe", "primaryDisplay": { "zh": "每支预充式注射器：度普利尤单抗 300 mg/2 mL（150 mg/mL）；2 支单剂量预充式注射器纸盒", "en": "Dupilumab 300 mg/2 mL (150 mg/mL) per pre-filled syringe; carton of 2 single-dose pre-filled syringes" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=595f437d-2729-40bb-9c62-c8ece1f82780&name=dupixent-126.jpg&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "度普利尤单抗", "en": "dupilumab" }, "value": 300, "unit": "mg", "basisCode": "per_prefilled_syringe", "basisLabel": { "zh": "每支预充式注射器的标签标示量；不是个人注射量或换算", "en": "labelled amount per pre-filled syringe; not an individual injection amount or conversion" } } ], "concentration": null, "container": { "typeCode": "prefilled_syringe_with_needle_shield", "typeLabel": { "zh": "带针头保护装置的单剂量预充式注射器", "en": "single-dose pre-filled syringe with needle shield" }, "fill": null, "countPerPackage": 2, "countUnit": { "zh": "支/盒", "en": "syringes per carton" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-22", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 2, "unit": { "zh": "支单剂量预充式注射器/盒", "en": "single-dose pre-filled syringes per carton" } }, "physicalClues": { "color": { "zh": "蓝绿色调纸盒", "en": "blue-green carton" }, "shape": { "zh": "2 支单剂量预充式注射器纸盒", "en": "carton of 2 single-dose pre-filled syringes" }, "imprint": "DUPIXENT / dupilumab / 300 mg/2 mL / NDC 0024-5914-01", "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_1aa16c22ccccc426", "label": "DailyMed（NLM）：DUPIXENT 度普利尤单抗当前美国公开标签（Sanofi-aventis U.S.；2026-04-22 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=595f437d-2729-40bb-9c62-c8ece1f82780", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-dupixent-dupilumab-300mg-2ml-two-prefilled-syringes-ndc-0024-5914-01", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=595f437d-2729-40bb-9c62-c8ece1f82780&name=dupixent-126.jpg&type=img", "alt": "DUPIXENT 度普利尤单抗在美国 DailyMed 当前标签中的 300 mg/2 mL、NDC 0024-5914-01、2 支单剂量预充式注射器纸盒展示面", "archiveMarket": "美国", "labelVersion": "DailyMed 美国公开标签（2026-04-22 更新）", "presentation": "DUPIXENT：度普利尤单抗 300 mg/2 mL（150 mg/mL），NDC 0024-5914-01，2 支单剂量预充式注射器纸盒。", "notice": "此图只对应美国 DailyMed 当前标签中的 DUPIXENT、度普利尤单抗、300 mg/2 mL（150 mg/mL）、NDC 0024-5914-01 与 2 支单剂量预充式注射器纸盒。它只帮助核对产品身份和来源；不用于鉴定真伪，也不证明预充式注射笔、200 mg/1.14 mL、其他包装、其他市场、当前可得性、原研身份、可替代性或任何个人的使用方案。", "source": { "id": "src_1aa16c22ccccc426", "label": "DailyMed（NLM）：DUPIXENT 度普利尤单抗当前美国公开标签（Sanofi-aventis U.S.；2026-04-22 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=595f437d-2729-40bb-9c62-c8ece1f82780", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "DUPIXENT 说明书放大阅读：先分清 300 mg/2 mL、150 mg/mL 与准确注射装置", "en": "DUPIXENT label reading: first distinguish 300 mg/2 mL, 150 mg/mL and the exact delivery device" }, "summary": { "zh": "本模块只阅读美国 DailyMed 当前公开标签中的 DUPIXENT 300 mg/2 mL 双支单剂量预充式注射器纸盒、NDC 与标签入口。它不提供个人注射量、时间表、漏用处理、开始、停用、联用、换药或购买方案。", "en": "This module reads only the DUPIXENT 300 mg/2 mL carton of two single-dose pre-filled syringes, NDC and label route in the current U.S. DailyMed public label. It provides no individual injection amount, schedule, missed-use handling, start, stop, co-use, switch or purchase plan." }, "checks": [ { "zh": "核对时要把 DUPIXENT、度普利尤单抗、300 mg/2 mL（150 mg/mL）、NDC 0024-5914-01、2 支单剂量预充式注射器、给药途径和目标市场放在一起看。只看到“dupilumab”“300 mg”或相近外盒颜色，不足以证明另一种笔式装置、强度、包装或国家/地区产品相同。", "en": "For checking, keep DUPIXENT, dupilumab, 300 mg/2 mL (150 mg/mL), NDC 0024-5914-01, two single-dose pre-filled syringes, route and target market together. Seeing only “dupilumab,” “300 mg,” or a similar carton colour does not establish that a pen device, strength, package or product in another country is the same." }, { "zh": "300 mg/2 mL 是这支准确产品的总标示量和体积，150 mg/mL 是浓度；二者都不是个人应使用多少或多久使用一次的指令。不要按包装数字自行推算、合并或替代其他强度或装置。", "en": "300 mg/2 mL is the labelled total amount and volume for this exact product, while 150 mg/mL is the concentration; neither is an instruction for how much or how often an individual should use it. Do not calculate, combine or substitute another strength or device from package numbers." }, { "zh": "本标签面板对应带针头保护装置的单剂量预充式注射器，不等同于预充式注射笔。装置操作、准备、遗漏、损坏、外观异常、储存或处置问题，应以手中准确产品的现行说明书和医生/药师指导为准；不要用网页替代实际产品说明。", "en": "This label panel is for a single-dose pre-filled syringe with needle shield, not a pre-filled pen. Device operation, preparation, missed use, damage, an unusual appearance, storage or disposal questions require the current instructions for the actual product and clinician/pharmacist guidance; do not use this webpage in place of the product instructions." }, { "zh": "如果担心过敏样反应、呼吸困难、面部或喉部肿胀、明显不适或其他急性问题，应立即使用当地紧急或医疗支持；不要因为网页上的通用信息自行继续、暂停或更换注射产品。", "en": "If concerned about an allergy-like reaction, breathing difficulty, swelling of the face or throat, marked illness or another acute problem, use local emergency or medical support immediately; do not independently continue, pause or change an injectable product from general web information." } ], "source": { "id": "src_1aa16c22ccccc426", "label": "DailyMed（NLM）：DUPIXENT 度普利尤单抗当前美国公开标签（Sanofi-aventis U.S.；2026-04-22 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=595f437d-2729-40bb-9c62-c8ece1f82780", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "度普利尤单抗的机制阅读：标签列为白细胞介素-4 受体 α 拮抗剂", "en": "Mechanism reading for dupilumab: the label classifies it as an interleukin-4 receptor alpha antagonist" }, "summary": { "zh": "美国 DUPIXENT 标签将度普利尤单抗列为白细胞介素-4 受体 α 拮抗剂。这个术语帮助读取产品的药理类别；它不预测某个人的症状、适用性、反应速度、联用选择或是否应改变治疗。", "en": "The U.S. DUPIXENT label classifies dupilumab as an interleukin-4 receptor alpha antagonist. This term helps read the product’s pharmacologic category; it does not predict an individual’s symptoms, suitability, response speed, co-use choice or whether treatment should change." }, "checks": [ { "zh": "药理类别不能替代对实际诊断、症状严重程度、既往反应、同时用药或手中准确装置的专业核对。不要因为机制名称相同或不同而自行加用、停用、轮换或替换注射产品。", "en": "A pharmacologic class cannot replace professional review of the actual diagnosis, symptom severity, prior reactions, co-medication or exact device in hand. Do not self-add, stop, alternate or replace an injectable product because a mechanism name is the same or different." }, { "zh": "同一通用名出现于不同强度、包装、装置或市场时，机制不会证明这些产品可互换。需要比较时，应先让专业人员核对准确产品、目标市场现行标签和完整用药清单。", "en": "When the same generic name appears in different strengths, packages, devices or markets, mechanism does not prove those products are interchangeable. For a comparison, first have a professional check the exact product, current label for the target market and complete medicine list." }, { "zh": "机制术语也不能解释注射部位问题、急性不适或是否应继续治疗。出现急性或明显不适时，应按当地紧急或医疗渠道处理，并让负责团队结合实际产品判断。", "en": "A mechanism term also cannot explain an injection-site concern, an acute illness or whether treatment should continue. With an acute or marked concern, use local emergency or clinical pathways and have the responsible team assess the actual product." } ], "source": { "id": "src_1aa16c22ccccc426", "label": "DailyMed（NLM）：DUPIXENT 度普利尤单抗当前美国公开标签（Sanofi-aventis U.S.；Clinical Pharmacology）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=595f437d-2729-40bb-9c62-c8ece1f82780", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "DUPIXENT", "generic": "度普利尤单抗", "dosageFormClass": "皮下注射液：单剂量预充式注射器（带针头保护装置）；本档案只对应所列 300 mg/2 mL、2 支纸盒" }, "labelSource": { "id": "src_1aa16c22ccccc426", "label": "DailyMed（NLM）：DUPIXENT 度普利尤单抗当前美国公开标签（Sanofi-aventis U.S.；2026-04-22 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=595f437d-2729-40bb-9c62-c8ece1f82780", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "productRoutes": [ { "source": { "id": "src_1aa16c22ccccc426", "label": "DailyMed（NLM）：DUPIXENT 度普利尤单抗当前美国公开标签（Sanofi-aventis U.S.；2026-04-22 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=595f437d-2729-40bb-9c62-c8ece1f82780", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_fd5dc076cf3bb402", "label": "FDA：DUPIXENT 度普利尤单抗美国处方信息（2026）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/761055s082lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "美国 DailyMed 当前公开标签将 DUPIXENT 列为度普利尤单抗皮下注射液。此档案只帮助把商品名、通用名、准确注射装置、每支标示量、纸盒数量、NDC 与美国公开标签逐项对应；它不把标签强度、设备名称或网页文字变成个人注射量、间隔、开始、停用、换药或购买建议。", "history": "FDA 当前标签列出该产品的美国初始批准年份为 2017。本档案保留的是 2026-04-22 更新的美国公开标签入口和其中一个准确纸盒面板；不同强度、预充式注射笔、其他市场标签和后续版本均须另行核对，不能因商品名或通用名相同而自行互换。", "sourceDocuments": [ { "id": "src_1aa16c22ccccc426", "label": "DailyMed（NLM）：DUPIXENT 度普利尤单抗当前美国公开标签（Sanofi-aventis U.S.；2026-04-22 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=595f437d-2729-40bb-9c62-c8ece1f82780", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_fd5dc076cf3bb402", "label": "FDA：DUPIXENT 度普利尤单抗美国处方信息（2026）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/761055s082lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } ], "applicationNumber": "BLA 761055（FDA 当前标签链接）/ DailyMed SPL setid 595f437d-2729-40bb-9c62-c8ece1f82780", "approvalTimeline": [ { "date": "2017", "title": { "zh": "当前美国标签所列初始批准年份", "en": "Initial U.S. approval year listed in the current label" }, "detail": { "zh": "FDA 2026 年 DUPIXENT 标签列示 Initial U.S. Approval: 2017。该年份仅定位美国产品标签历史，不推定其他市场的批准、供应、可售资格、原研/仿制关系或任何个人适用性。", "en": "The FDA 2026 DUPIXENT label lists Initial U.S. Approval: 2017. This year only locates the U.S. product-label history; it does not establish approval, supply, sale eligibility, originator/generic relationship or individual suitability in another market." }, "source": { "id": "src_fd5dc076cf3bb402", "label": "FDA：DUPIXENT 度普利尤单抗美国处方信息（2026）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/761055s082lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, { "date": "2026-04-22", "title": { "zh": "DailyMed 当前公开标签更新", "en": "Current DailyMed public label updated" }, "detail": { "zh": "DailyMed 将该美国公开标签的 Updated 日期列为 2026-04-22。本页只用此版本核对 300 mg/2 mL、NDC 0024-5914-01 与 2 支单剂量预充式注射器纸盒；不据此判断实际在售、库存、购买或个人使用安排。", "en": "DailyMed lists 22 Apr 2026 as the Updated date for this U.S. public label. This page uses that version only to check 300 mg/2 mL, NDC 0024-5914-01 and the two-syringe carton; it does not establish actual marketing, stock, purchase or an individual use plan." }, "source": { "id": "src_1aa16c22ccccc426", "label": "DailyMed（NLM）：DUPIXENT 度普利尤单抗当前美国公开标签（Sanofi-aventis U.S.；2026-04-22 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=595f437d-2729-40bb-9c62-c8ece1f82780", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "已链接当前公开标签与一个准确预充式注射器纸盒面板", "en": "Current public label and one exact pre-filled-syringe carton panel linked" }, "detail": { "zh": "本页只展示 DUPIXENT 度普利尤单抗 300 mg/2 mL（150 mg/mL）、NDC 0024-5914-01、2 支单剂量预充式注射器（带针头保护装置）纸盒。它不用于鉴定真伪，也不建立实际在售、库存、购买、个人注射量、时间表、装置操作、换药或可替代性。", "en": "This page displays only the DUPIXENT dupilumab 300 mg/2 mL (150 mg/mL), NDC 0024-5914-01 carton of two single-dose pre-filled syringes with needle shield. It does not authenticate a product or establish actual marketing, stock, purchase, individual injection amount, schedule, device operation, switching or interchangeability." } }, { "market": { "zh": "中国大陆、欧盟、日本及其他市场", "en": "Mainland China, EU, Japan and other markets" }, "status": { "zh": "待逐项建立现行市场记录", "en": "Current market record not established" }, "detail": { "zh": "不从美国标签、BLA、NDC、英文品牌、装置名称或包装图推定当地商品名、批准、包装、供应、可售资格、原研/仿制关系或可替代性；每个市场均须按当地现行监管资料单独核对。", "en": "No local trade name, approval, packaging, supply, sale eligibility, originator/generic relationship or interchangeability is inferred from the U.S. label, BLA, NDC, English brand, device name or package image; every market requires separate checking against current local regulatory material." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "同为度普利尤单抗，预充式注射器、预充式注射笔或不同强度能否按毫克数自行换用？", "en": "With the same generic name dupilumab, can a pre-filled syringe, a pre-filled pen or another strength be self-switched by milligram amount?" }, "answer": { "zh": "不能。装置、强度、包装、标签版本、市场和处方都属于产品身份的一部分。相同通用名或相近毫克数不建立换算或替代关系；请把实际产品和完整用药清单交给药师或开方团队核对。", "en": "No. Device, strength, package, label version, market and prescription are all parts of product identity. A shared generic name or similar milligram amount does not create a conversion or substitution relationship; take the actual product and full medicine list to a pharmacist or prescribing team." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "dosage-forms-are-part-of-medicine-identity", "how-to-read-a-drug-label" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/dupixent/", "en": "https://origindrug.com/en/drugs/dupixent/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "plaquenil", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-21", "status": "published_traceable_archive" }, "names": { "brand": "PLAQUENIL", "generic": "羟氯喹硫酸盐", "aliases": [ "PLAQUENIL", "hydroxychloroquine sulfate", "hydroxychloroquine", "羟氯喹硫酸盐", "羟氯喹" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "免疫", "sourceArchiveMarket": "美国 PLAQUENIL 羟氯喹硫酸盐口服薄膜衣片公开标签（DailyMed SPL v15，2026-05-21 发布）", "dosageFormClass": "口服薄膜衣片：每片羟氯喹硫酸盐 200 mg（相当于羟氯喹 155 mg）；本档案精确展示 NDC 59212-562-10 的 100 片瓶装", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "1955（当前美国标签所列 Initial U.S. Approval）", "archiveSponsorText": "Advanz Pharma US Corp. / DailyMed（NLM）当前公开标签档案" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-plaquenil-hydroxychloroquine-sulfate-200mg-100-tablet-bottle-ndc-59212-562-10", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v15，2026-05-21 发布", "en": "DailyMed SPL v15, published 21 May 2026" }, "dosageForm": { "zh": "羟氯喹硫酸盐口服薄膜衣片", "en": "hydroxychloroquine sulfate film-coated oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 59212-562-10", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片羟氯喹硫酸盐 200 mg（相当于羟氯喹 155 mg）；100 片瓶装", "en": "Hydroxychloroquine sulfate 200 mg per tablet (equivalent to 155 mg hydroxychloroquine); 100-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=34496b43-05a2-45fb-a769-52b12e099341&name=100-counts.jpg", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "羟氯喹硫酸盐", "en": "hydroxychloroquine sulfate" }, "value": 200, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签量；不是个人片数或使用方案", "en": "labelled amount per tablet; not an individual's tablet count or use plan" } }, { "ingredient": { "zh": "羟氯喹", "en": "hydroxychloroquine" }, "value": 155, "unit": "mg", "basisCode": "equivalent_base_per_tablet", "basisLabel": { "zh": "标签所列每片相当于羟氯喹的量；不是换算或调整指令", "en": "labelled hydroxychloroquine-equivalent amount per tablet; not a conversion or adjustment instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 1, "countUnit": { "zh": "瓶/包", "en": "bottle per pack" }, "unitsPerContainer": { "count": 100, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": null, "package": { "count": 100, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "白色至类白色", "en": "white to off-white" }, "shape": { "zh": "薄膜衣片", "en": "film-coated tablet" }, "imprint": "PLAQUENIL", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_39d67a95fcd742c9", "label": "DailyMed（NLM）：PLAQUENIL 羟氯喹硫酸盐当前美国公开标签（Advanz Pharma US Corp.；SPL v15，2026-05-21 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=34496b43-05a2-45fb-a769-52b12e099341", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-plaquenil-hydroxychloroquine-sulfate-200mg-100-tablet-bottle-ndc-59212-562-10", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=34496b43-05a2-45fb-a769-52b12e099341&name=100-counts.jpg", "alt": "PLAQUENIL 羟氯喹硫酸盐在美国 DailyMed 当前公开标签中的 200 mg、NDC 59212-562-10、100 片瓶装展示面", "archiveMarket": "美国", "labelVersion": "DailyMed SPL v15（2026-05-21 发布）", "presentation": "PLAQUENIL 羟氯喹硫酸盐口服薄膜衣片：每片 200 mg（相当于羟氯喹 155 mg），NDC 59212-562-10、100 片瓶装展示面。", "notice": "此图只对应美国 DailyMed 当前公开标签中的 PLAQUENIL 羟氯喹硫酸盐口服薄膜衣片、每片 200 mg（相当于羟氯喹 155 mg）、NDC 59212-562-10、100 片瓶装展示面。它不代表其他 NDC、其他包装、其他市场、实际可得性、原研身份或可替代性；标签注明该片不应压碎或掰开，本页不把此图或毫克数字转成个人片数、联用、换药、停药或其他治疗结论，也不用于鉴定真伪。", "source": { "id": "src_39d67a95fcd742c9", "label": "DailyMed（NLM）：PLAQUENIL 羟氯喹硫酸盐当前美国公开标签（Advanz Pharma US Corp.；SPL v15，2026-05-21 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=34496b43-05a2-45fb-a769-52b12e099341", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "PLAQUENIL 说明书放大阅读：先核对每片 200 mg、准确瓶装与完整药单", "en": "PLAQUENIL label reading: check 200 mg per tablet, the exact bottle and the complete medicine list first" }, "summary": { "zh": "本模块以美国 DailyMed 当前公开标签为入口，帮助核对 PLAQUENIL、羟氯喹硫酸盐、口服薄膜衣片、每片标签量、准确瓶装与目标市场。它不提供个人片数、疗程、漏用补救、联用、停药或换药方案。", "en": "This module uses the current U.S. DailyMed public label to check PLAQUENIL, hydroxychloroquine sulfate, film-coated oral tablets, labelled amount per tablet, the exact bottle and target market. It provides no individual tablet count, course, missed-use remedy, combination, stopping or switching plan." }, "checks": [ { "zh": "“200 mg”是这一准确片剂每片的标签量，并不是任何人每天该吃几片的网页指令；同一名称、不同市场、不同包装或另一种剂型都不能只按一个数字自行换算。", "en": "“200 mg” is the labelled amount in each tablet of this exact product, not a webpage instruction for how many tablets any person should take per day. The same name, a different market, another pack or another dosage form cannot be self-converted from one number." }, { "zh": "当前标签写明本片不应压碎或掰开。不要把“分成两半”当作减半、补用、调整或与其他药互换的办法；如实际药盒、吞咽状况或处方与页面不同，请带着实物问药师或开方团队。", "en": "The current label states that these tablets should not be crushed or divided. Do not treat “half a tablet” as a way to halve, make up, adjust or interchange medicine; if the actual pack, swallowing situation or prescription differs from this page, take the pack to a pharmacist or prescribing team." }, { "zh": "当前标签提示视网膜毒性与累计用量和治疗时间有关，并列出基线及治疗期间眼科检查。网页不能据此判断个人眼部症状、是否需要检查或何时调整；出现视力变化或其他担忧时，应尽快联系当地医疗团队。", "en": "The current label notes that retinal toxicity is related to cumulative dosage and treatment duration and lists baseline and during-treatment eye examinations. A webpage cannot decide an individual's eye symptoms, need for testing or timing of adjustment; contact the local care team promptly for visual changes or another concern." }, { "zh": "标签还提示心肌病、心律失常及多种合并药物相关风险。不要凭网页把任何降糖药、抗癫痫药、免疫相关药、抗感染药、胃药、草本或补充剂自行加、停、换或错开；请带完整处方药、非处方药与补充剂清单逐项让医生或药师核对。", "en": "The label also notes cardiomyopathy, arrhythmias and risks involving multiple co-medications. Do not self-add, stop, switch or separate any glucose-lowering medicine, antiseizure medicine, immune-related medicine, anti-infective, stomach medicine, herb or supplement from a webpage; have a clinician or pharmacist review the complete prescription, OTC and supplement list item by item." } ], "source": { "id": "src_39d67a95fcd742c9", "label": "DailyMed（NLM）：PLAQUENIL 羟氯喹硫酸盐当前美国公开标签（Warnings, Dosage and Administration, Patient Counseling；Advanz Pharma US Corp.；SPL v15）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=34496b43-05a2-45fb-a769-52b12e099341", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "PLAQUENIL 怎样起作用：标签所述抗炎/免疫调节路径仍有未完全明确之处", "en": "How PLAQUENIL works: the label describes anti-inflammatory and immunomodulatory pathways that remain incompletely understood" }, "summary": { "zh": "美国 PLAQUENIL 标签将羟氯喹描述为 4-氨基喹啉类抗疟药和抗风湿药，并说明其在类风湿关节炎、系统性红斑狼疮及皮肤型红斑狼疮中的抗炎/免疫调节作用机制尚未完全明确。机制阅读帮助理解标签边界，不判断任何人的诊断、疗效、片数或联用结果。", "en": "The U.S. PLAQUENIL label describes hydroxychloroquine as a 4-aminoquinoline antimalarial and antirheumatic drug, and states that its anti-inflammatory/immunomodulatory mechanism in rheumatoid arthritis, systemic lupus erythematosus and chronic discoid lupus erythematosus is not fully understood. Mechanism reading helps interpret label boundaries; it does not decide anyone's diagnosis, response, tablet count or co-use result." }, "checks": [ { "zh": "“机制尚未完全明确”不是资料缺失后的猜测空间，而是提醒不能从一个机制词推断某个人一定有效、一定无效，或自行改变治疗方案。", "en": "“Not fully understood” is not space for a guess after missing information; it is a reminder that one mechanism term cannot predict that an individual will respond, will not respond or should self-change a treatment plan." }, { "zh": "“抗炎”“免疫调节”或“抗疟”是标签中的类别/作用线索，不是把不同疾病、不同剂型、不同品牌或相同通用名产品自动视为可替代、可同用或可按相同片数使用的依据。", "en": "“Anti-inflammatory”, “immunomodulatory” or “antimalarial” are labelled class/action clues, not grounds to treat different diseases, dosage forms, brands or products sharing a generic name as automatically interchangeable, combinable or usable at the same tablet count." }, { "zh": "对合并多药的老人或家属，最有用的下一步不是尝试从机制推演相互作用，而是把每一盒药、每一种非处方药和补充剂列齐，让药师或医生依准确诊断、检查和现行标签进行复核。", "en": "For an older person or family member using multiple medicines, the useful next step is not to reason out interactions from a mechanism. List every pack, OTC product and supplement so a pharmacist or clinician can review them against the exact diagnosis, tests and current labels." } ], "source": { "id": "src_39d67a95fcd742c9", "label": "DailyMed（NLM）：PLAQUENIL 羟氯喹硫酸盐当前美国公开标签（Clinical Pharmacology；Advanz Pharma US Corp.；SPL v15）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=34496b43-05a2-45fb-a769-52b12e099341", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "PLAQUENIL", "generic": "羟氯喹硫酸盐", "dosageFormClass": "口服薄膜衣片：每片羟氯喹硫酸盐 200 mg（相当于羟氯喹 155 mg）；本档案精确展示 NDC 59212-562-10 的 100 片瓶装" }, "labelSource": { "id": "src_39d67a95fcd742c9", "label": "DailyMed（NLM）：PLAQUENIL 羟氯喹硫酸盐当前美国公开标签（Advanz Pharma US Corp.；SPL v15，2026-05-21 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=34496b43-05a2-45fb-a769-52b12e099341", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "productRoutes": [ { "source": { "id": "src_39d67a95fcd742c9", "label": "DailyMed（NLM）：PLAQUENIL 羟氯喹硫酸盐当前美国公开标签（Advanz Pharma US Corp.；SPL v15，2026-05-21 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=34496b43-05a2-45fb-a769-52b12e099341", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "美国 DailyMed 的 PLAQUENIL 公开标签将其列为羟氯喹硫酸盐口服薄膜衣片。本页帮助核对商品名、通用名、每片标签量、准确瓶装面板、目标市场和标签版本；它不把 200 mg 变成任何人的片数、疗程、联用、换药、停药或购买建议。", "history": "当前美国公开标签列示 Initial U.S. Approval: 1955。该年份只定位这一美国公开标签档案；相近名称、相同通用名、不同包装或其他市场版本，都需要按准确产品和当地现行资料重新核对。", "sourceDocuments": [ { "id": "src_39d67a95fcd742c9", "label": "DailyMed（NLM）：PLAQUENIL 羟氯喹硫酸盐当前美国公开标签（Advanz Pharma US Corp.；SPL v15，2026-05-21 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=34496b43-05a2-45fb-a769-52b12e099341", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } ], "applicationNumber": "NDA 009768", "approvalTimeline": [ { "date": "1955", "title": { "zh": "当前标签所列美国初始批准年份", "en": "Initial U.S. approval year listed in the current label" }, "detail": { "zh": "当前 PLAQUENIL 标签列示 Initial U.S. Approval: 1955。该年份只定位这一美国档案，不建立中国大陆、欧盟、日本或其他市场的批准、供应、可售资格、原研/仿制关系或个人适用性。", "en": "The current PLAQUENIL label lists Initial U.S. Approval: 1955. This year locates this U.S. archive only; it does not establish approval, supply, sale eligibility, originator/generic relationship or individual suitability in Mainland China, the EU, Japan or another market." }, "source": { "id": "src_39d67a95fcd742c9", "label": "DailyMed（NLM）：PLAQUENIL 羟氯喹硫酸盐当前美国公开标签（Advanz Pharma US Corp.；SPL v15，2026-05-21 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=34496b43-05a2-45fb-a769-52b12e099341", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, { "date": "2026-05-21", "title": { "zh": "DailyMed 当前公开 SPL v15", "en": "Current public SPL v15 published on DailyMed" }, "detail": { "zh": "DailyMed 将该 PLAQUENIL 口服薄膜衣片 SPL v15 的发布日期列为 2026-05-21。本页只选取一个准确 200 mg、NDC 59212-562-10、100 片瓶装面板，不据此推定其他 NDC、包装、市场、库存、疗程、个人片数、联用或替代关系。", "en": "DailyMed lists 21 May 2026 as the publication date for PLAQUENIL film-coated oral-tablet SPL v15. This page selects only one exact 200 mg, NDC 59212-562-10, 100-tablet bottle panel and does not establish another NDC, pack, market, stock, course, individual tablet count, co-use or substitution relationship." }, "source": { "id": "src_39d67a95fcd742c9", "label": "DailyMed（NLM）：PLAQUENIL 羟氯喹硫酸盐当前美国公开标签（Advanz Pharma US Corp.；SPL v15，2026-05-21 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=34496b43-05a2-45fb-a769-52b12e099341", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "已链接当前口服薄膜衣片标签与一个准确瓶装面板", "en": "Current film-coated-tablet label and one exact bottle panel linked" }, "detail": { "zh": "本页展示的面板只对应羟氯喹硫酸盐每片 200 mg（相当于羟氯喹 155 mg）、NDC 59212-562-10、100 片瓶装。它不建立实际在售、库存、个人片数、治疗时长、检查安排、联用、停药、换药或其他包装状态。", "en": "The displayed panel only corresponds to hydroxychloroquine sulfate 200 mg per tablet (equivalent to 155 mg hydroxychloroquine), NDC 59212-562-10, 100-tablet bottle. It does not establish actual availability, stock, individual tablet count, treatment duration, testing schedule, co-use, stopping, switching or another-pack status." } }, { "market": { "zh": "中国大陆、欧盟、日本及其他市场", "en": "Mainland China, EU, Japan and other markets" }, "status": { "zh": "待逐项建立市场记录", "en": "Market record not established" }, "detail": { "zh": "不从美国标签或品牌名称推定当地商品名、批准、包装、供应、可售资格、原研/仿制关系或可替代性；任何市场版本均需按当地现行监管资料单独核对。", "en": "No local trade name, approval, packaging, supply, sale eligibility, originator/generic relationship or interchangeability is inferred from the U.S. label or brand name; every market version needs separate checking against current local regulatory information." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "PLAQUENIL 200 mg 是否表示一天吃一片，或可以掰半片减量？", "en": "Does PLAQUENIL 200 mg mean one tablet a day, or that half a tablet can be used to reduce a dose?" }, "answer": { "zh": "不是。200 mg 是这一准确片剂每片的标签量；当前标签写明不应压碎或掰开。网页不把标签量变成个人片数、减量、补用、疗程、换药或其他调整规则。请带实际药瓶、处方和完整药单向药师或开方团队核对。", "en": "No. 200 mg is the labelled amount in each tablet of this exact product; the current label states that it should not be crushed or divided. This page does not turn a labelled amount into an individual tablet count, reduction, make-up use, course, switch or adjustment rule. Take the actual bottle, prescription and complete medicine list to a pharmacist or prescribing team." } }, { "question": { "zh": "为什么页面提示眼睛、心脏和所有合并药都要一起核对？", "en": "Why does the page say that eyes, the heart and all co-medications need joint review?" }, "answer": { "zh": "这是当前标签中视网膜毒性、心肌病/心律失常及相互作用警示的阅读入口，并不替代个人风险判断。视力变化、心悸、晕厥或其他急性严重不适应及时联系当地医疗团队；所有药物、非处方药和补充剂应由熟悉准确处方的人逐项复核。", "en": "It is a reading entry point for the current label's retinal-toxicity, cardiomyopathy/arrhythmia and interaction warnings, not a substitute for an individual risk assessment. Contact local medical care promptly for visual changes, palpitations, fainting or another acute serious concern; every medicine, OTC product and supplement should be reviewed item by item by someone who knows the exact prescription." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "dosage-forms-are-part-of-medicine-identity", "how-to-read-a-drug-label" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/plaquenil/", "en": "https://origindrug.com/en/drugs/plaquenil/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "cellcept", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-28", "status": "published_traceable_archive" }, "names": { "brand": "CellCept", "generic": "吗替麦考酚酯", "aliases": [ "CELLCEPT", "mycophenolate mofetil", "吗替麦考酚酯", "霉酚酸吗啉乙酯" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "免疫", "sourceArchiveMarket": "美国 CELLCEPT 吗替麦考酚酯当前公开标签（DailyMed SPL v1，2026-08-10 发布；标签涵盖口服胶囊、口服片、复溶后口服混悬液及静脉用制剂；本档案只建立口服阅读入口）", "dosageFormClass": "吗替麦考酚酯口服胶囊、口服片与复溶后口服混悬液（美国当前公开标签所列；不同剂型与霉酚酸肠溶片不建立自行换算或替换关系）", "dosageFormClassCode": "oral_modified_release", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "1995（美国当前公开标签所列 Initial U.S. Approval）", "archiveSponsorText": "Genentech, Inc.（所引美国公开标签所列）" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [ "mycophenolic acid delayed-release tablet", "Myfortic", "mycophenolate sodium", "霉酚酸肠溶片", "麦考酚钠", "other mycophenolate product", "其他吗替麦考酚酯产品" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-cellcept-mycophenolate-mofetil-capsule-250mg-current-source-text", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v1（2026-08-10 发布）", "en": "DailyMed SPL v1 (published 10 Aug 2026)" }, "dosageForm": { "zh": "CELLCEPT 吗替麦考酚酯口服胶囊", "en": "CELLCEPT mycophenolate mofetil oral capsule" }, "route": { "zh": "口服（标签产品身份字段）", "en": "oral (label product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "Current public label — oral capsule; no exact package panel established", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_capsule", "primaryDisplay": { "zh": "每粒吗替麦考酚酯 250 mg（美国当前标签的胶囊文字身份；未建立包装面板）", "en": "Mycophenolate mofetil 250 mg per capsule (current U.S. label text identity; no exact package panel established)" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "吗替麦考酚酯（每粒）", "en": "mycophenolate mofetil (per capsule)" }, "value": 250, "unit": "mg", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒标签标示量；不是个人胶囊数、频率或换算指令", "en": "Labelled amount per capsule; not an individual's capsule count, frequency or conversion instruction" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-26", "currentLabelDisplayed": true, "ndcDirectoryListed": false, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": null, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_714e9eb8d87c343c", "label": "DailyMed（NLM）：CELLCEPT 吗替麦考酚酯当前美国公开标签（Genentech；SPL v1，2026-08-10 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=37241e87-4af4-4dc3-a1aa-ea6f20d8dc40&version=1", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-26", "reviewedAt": "2026-08-26" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-cellcept-mycophenolate-mofetil-tablet-500mg-current-source-text", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v1（2026-08-10 发布）", "en": "DailyMed SPL v1 (published 10 Aug 2026)" }, "dosageForm": { "zh": "CELLCEPT 吗替麦考酚酯口服片", "en": "CELLCEPT mycophenolate mofetil oral tablet" }, "route": { "zh": "口服（标签产品身份字段）", "en": "oral (label product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "Current public label — oral tablet; no exact package panel established", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片吗替麦考酚酯 500 mg（美国当前标签的片剂文字身份；未建立包装面板）", "en": "Mycophenolate mofetil 500 mg per tablet (current U.S. label text identity; no exact package panel established)" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "吗替麦考酚酯（每片）", "en": "mycophenolate mofetil (per tablet)" }, "value": 500, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、频率或换算指令", "en": "Labelled amount per tablet; not an individual's tablet count, frequency or conversion instruction" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-26", "currentLabelDisplayed": true, "ndcDirectoryListed": false, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": null, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_714e9eb8d87c343c", "label": "DailyMed（NLM）：CELLCEPT 吗替麦考酚酯当前美国公开标签（Genentech；SPL v1，2026-08-10 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=37241e87-4af4-4dc3-a1aa-ea6f20d8dc40&version=1", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-26", "reviewedAt": "2026-08-26" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-cellcept-mycophenolate-mofetil-oral-suspension-200mg-per-ml-current-source-text", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v1（2026-08-10 发布）", "en": "DailyMed SPL v1 (published 10 Aug 2026)" }, "dosageForm": { "zh": "CELLCEPT 吗替麦考酚酯复溶后口服混悬液", "en": "CELLCEPT mycophenolate mofetil oral suspension after reconstitution" }, "route": { "zh": "口服（标签产品身份字段）", "en": "oral (label product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "Current public label — oral suspension after reconstitution; no exact package panel established", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_mL", "primaryDisplay": { "zh": "复溶后每 mL 含吗替麦考酚酯 200 mg（美国当前标签的混悬液文字身份；未建立包装面板）", "en": "Mycophenolate mofetil 200 mg per mL after reconstitution (current U.S. label text identity; no exact package panel established)" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "吗替麦考酚酯（复溶后每 mL）", "en": "mycophenolate mofetil (per mL after reconstitution)" }, "value": 200, "unit": "mg", "basisCode": "per_mL", "basisLabel": { "zh": "复溶后每 mL 的标签浓度；不是个人毫升数、量取或换算指令", "en": "Labelled concentration per mL after reconstitution; not an individual's millilitre amount, measuring or conversion instruction" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-26", "currentLabelDisplayed": true, "ndcDirectoryListed": false, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": null, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_714e9eb8d87c343c", "label": "DailyMed（NLM）：CELLCEPT 吗替麦考酚酯当前美国公开标签（Genentech；SPL v1，2026-08-10 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=37241e87-4af4-4dc3-a1aa-ea6f20d8dc40&version=1", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-26", "reviewedAt": "2026-08-26" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "status": "withheld_repackaged_or_non_exact_visual", "title": { "zh": "已核验当前公开标签文字，但未保留与单一剂型、单一强度和单一包装一一对应的官方原品牌包装图，故不展示包装图片", "en": "Current public-label text was reviewed, but no official original-brand package image matching one exact dosage form, strength and package was retained, so no package visual is shown" }, "summary": { "zh": "本档案保留 CELLCEPT、吗替麦考酚酯、口服胶囊、口服片、复溶后口服混悬液、静脉用制剂、美国当前公开标签及文件日期。该标签覆盖多种剂型和产品展示面，未保留可同时准确对应单一剂型、单一规格和单一包装且可安全公开展示的官方原品牌图片；为避免把零售图、再包装图、版本不明图、其他市场图片或另一种吗替麦考酚酯/霉酚酸产品误作准确 CELLCEPT 外观，页面不展示包装图片，只保留一手标签供放大阅读。", "en": "This dossier retains CELLCEPT, mycophenolate mofetil, oral capsules, oral tablets, reconstituted oral suspension, intravenous formulation, the current U.S. public label and its date. The label spans several dosage forms and presentations, and no official original-brand image was retained that safely matches one exact form, strength and package; to avoid presenting a retail image, repackaged image, version-uncertain image, another-market image or another mycophenolate/mycophenolic-acid product as the exact CELLCEPT appearance, the page withholds package imagery and retains the primary label for enlarged reading." }, "source": { "id": "src_714e9eb8d87c343c", "label": "DailyMed（NLM）：CELLCEPT 吗替麦考酚酯当前美国公开标签（Genentech；SPL v1，2026-08-10 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=37241e87-4af4-4dc3-a1aa-ea6f20d8dc40&version=1", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-26", "reviewedAt": "2026-08-26" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "CELLCEPT／吗替麦考酚酯说明书放大阅读：先分清准确剂型，再看重要警示", "en": "CELLCEPT label reading: identify the exact dosage form before reading important warnings" }, "summary": { "zh": "本模块使用美国 DailyMed 当前公开标签，帮助区分 CELLCEPT、吗替麦考酚酯、口服胶囊、口服片、复溶后口服混悬液与静脉用制剂。它不提供个人片数、毫升数、开始、停用、转换、联用或诊断建议。", "en": "This module uses the current U.S. DailyMed public label to distinguish CELLCEPT, mycophenolate mofetil, oral capsules, oral tablets, reconstituted oral suspension and intravenous formulation. It provides no individual capsule/tablet count, millilitre amount, starting, stopping, conversion, co-use or diagnostic advice." }, "checks": [ { "zh": "先把实际包装上的 CELLCEPT、吗替麦考酚酯、剂型、每单位标示量或浓度、包装和目标市场一起核对。mg 或 mg/mL 是明确单位中的标示量或浓度，不是网页给任何人的片数、胶囊数或混悬液体积。", "en": "Check CELLCEPT, mycophenolate mofetil, dosage form, labelled amount or concentration per defined unit, pack and target market together. mg or mg/mL is a labelled amount or concentration in a defined unit, not a website instruction for anyone's number of tablets/capsules or suspension volume." }, { "zh": "标签明确指出：CELLCEPT 口服剂型与霉酚酸延迟释放片的吸收速度不同，未经有免疫抑制治疗经验的医生监督不应自行互换。共同的“霉酚酸”字样、相近 mg、相同移植背景或相似药盒，都不能建立自行转换、叠加、轮换或替代关系。", "en": "The label states that CELLCEPT oral forms and mycophenolic-acid delayed-release tablets have different absorption rates and should not be interchanged without supervision by a physician experienced in immunosuppressive therapy. Shared “mycophenolic” wording, nearby mg numbers, the same transplant context or a similar pack do not establish self-conversion, combining, alternation or substitution." }, { "zh": "标签列有胚胎-胎儿毒性、恶性肿瘤和严重感染的加框警示。怀孕、备孕、感染、发热、接触水痘/带状疱疹、接种、血液检查或任何治疗变化，都需要把实际药盒和完整药单交给移植/专科团队或药师逐项核对；网页不能给出继续、暂停或更换结论。", "en": "The label carries a boxed warning for embryo-fetal toxicity, malignancies and serious infections. Pregnancy or planning, infection, fever, exposure to chickenpox/shingles, vaccination, blood tests or any treatment change require item-by-item review of the actual pack and full medicine list with the transplant/specialist team or pharmacist; this site cannot decide whether to continue, pause or change treatment." }, { "zh": "标签说明 CELLCEPT 片剂不应研碎，胶囊不应打开或研碎；复溶后口服混悬液也不应在服用前与其他液体混合。不要把“掰开、打开或混入”的问题理解为网页能替代实际说明书和专业人员的许可；若发生粉末接触皮肤、黏膜或眼部，或有急性严重担忧，应优先遵照现行标签并联系当地医疗支持。", "en": "The label says CELLCEPT tablets should not be crushed and capsules should not be opened or crushed; reconstituted oral suspension should not be mixed with other liquids before use. Do not treat a question about splitting, opening or mixing as website permission in place of the actual label and professional advice. With powder contact involving skin, mucosa or eyes, or an acute serious concern, follow the current label first and contact local medical support." } ], "source": { "id": "src_714e9eb8d87c343c", "label": "DailyMed（NLM）：CELLCEPT 吗替麦考酚酯当前美国公开标签（Genentech；SPL v1，2026-08-10 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=37241e87-4af4-4dc3-a1aa-ea6f20d8dc40&version=1", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-26", "reviewedAt": "2026-08-26" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "吗替麦考酚酯怎样起作用：机制术语不是免疫抑制方案", "en": "How mycophenolate mofetil works: mechanism terminology is not an immunosuppression plan" }, "summary": { "zh": "所引标签描述吗替麦考酚酯在体内转化为霉酚酸，并涉及嘌呤合成途径。这帮助理解说明书术语；不能判断个人感染、排斥风险、血液检查异常、妊娠风险、联用、剂量、转换或停药方案。", "en": "The cited label describes conversion of mycophenolate mofetil to mycophenolic acid and a purine-synthesis pathway. This helps read label terminology; it cannot determine an individual's infection, rejection risk, abnormal blood tests, pregnancy risk, co-use, dose, conversion or stopping plan." }, "checks": [ { "zh": "“免疫抑制”或“嘌呤合成”不是把 CELLCEPT 与任何霉酚酸产品、其他移植药、激素、抗感染药、非处方药或补充剂自行叠加、轮换或替代的依据。", "en": "“Immunosuppression” or “purine synthesis” is not a basis for self-combining, alternating or substituting CELLCEPT with any mycophenolic-acid product, other transplant medicine, steroid, anti-infective medicine, OTC product or supplement." }, { "zh": "机制页不能解释个人发热、腹泻、皮疹、疲劳、感染迹象、检查结果或移植相关担忧的原因，也不能判断是否来自某一种药。出现这些问题时，应把实际药盒和完整药单带给当地移植/专科团队或药师。", "en": "A mechanism page cannot explain the cause of an individual's fever, diarrhoea, rash, fatigue, infection signs, test result or transplant-related concern, or decide whether it comes from one medicine. With such a concern, take the actual pack and full medicine list to a local transplant/specialist team or pharmacist." }, { "zh": "出现呼吸困难、面部或咽喉肿胀、昏厥、严重感染迹象、无法进食饮水、严重出血或其他急性严重担忧时，应优先使用当地紧急医疗支持；不要依据机制自行同时改变多种药物。", "en": "With breathing difficulty, swelling of the face or throat, fainting, signs of severe infection, inability to eat or drink, serious bleeding or another acute serious concern, prioritise local emergency medical support; do not change several medicines yourself from a mechanism explanation." } ], "source": { "id": "src_714e9eb8d87c343c", "label": "DailyMed（NLM）：CELLCEPT 吗替麦考酚酯当前美国公开标签（Clinical Pharmacology；Genentech；SPL v1）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=37241e87-4af4-4dc3-a1aa-ea6f20d8dc40&version=1", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-26", "reviewedAt": "2026-08-26" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "CellCept", "generic": "吗替麦考酚酯", "dosageFormClass": "吗替麦考酚酯口服胶囊、口服片与复溶后口服混悬液（美国当前公开标签所列；不同剂型与霉酚酸肠溶片不建立自行换算或替换关系）" }, "labelSource": { "id": "src_714e9eb8d87c343c", "label": "DailyMed（NLM）：CELLCEPT 吗替麦考酚酯当前美国公开标签（Genentech；SPL v1，2026-08-10 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=37241e87-4af4-4dc3-a1aa-ea6f20d8dc40&version=1", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-26", "reviewedAt": "2026-08-26" }, "productRoutes": [ { "source": { "id": "src_714e9eb8d87c343c", "label": "DailyMed（NLM）：CELLCEPT 吗替麦考酚酯当前美国公开标签（Genentech；SPL v1，2026-08-10 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=37241e87-4af4-4dc3-a1aa-ea6f20d8dc40&version=1", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-26", "reviewedAt": "2026-08-26" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-26", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-26", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "美国 DailyMed 当前 CELLCEPT 公开标签涵盖吗替麦考酚酯的口服胶囊、口服片、复溶后口服混悬液及静脉用制剂。本页帮助读者先辨认准确产品和标签警示；不把包装、浓度、毫克数或网页文字换算成任何人的剂量、片数、混悬液体积、联用、停用、换药或照护决定。", "history": "所引当前美国公开标签列示 Initial U.S. Approval: 1995，SPL v1 于 2026-08-10 发布。标签明确指出 CELLCEPT 口服剂型与霉酚酸延迟释放片的吸收速度不同，不能在缺乏具有免疫抑制治疗经验的医生监督下自行互换；胶囊、片剂、混悬液和静脉制剂也必须按准确剂型、现行标签和专业团队分别核对。", "sourceDocuments": [ { "id": "src_714e9eb8d87c343c", "label": "DailyMed（NLM）：CELLCEPT 吗替麦考酚酯当前美国公开标签（Genentech；SPL v1，2026-08-10 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=37241e87-4af4-4dc3-a1aa-ea6f20d8dc40&version=1", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-26", "reviewedAt": "2026-08-26" } ], "applicationNumber": "NDA 050722（CELLCEPT 美国当前公开标签所列）", "approvalTimeline": [ { "date": "1995", "title": { "zh": "FDA 标签所列美国初始批准年份", "en": "Initial U.S. approval year listed in the FDA label" }, "detail": { "zh": "本页链接的 FDA 标签档案列示 Initial U.S. Approval: 1995。该历史定位不等同于当前批准、可得性、持有人或其他市场状态。", "en": "The FDA label archive linked here lists Initial U.S. Approval: 1995. This historical locator is not a conclusion about current approval, availability, holder or another market." }, "source": { "id": "src_714e9eb8d87c343c", "label": "DailyMed: CELLCEPT mycophenolate mofetil current U.S. public label", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=37241e87-4af4-4dc3-a1aa-ea6f20d8dc40&version=1", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-26", "reviewedAt": "2026-08-26" } }, { "date": "DailyMed SPL v1, published 2026-08-10", "title": { "zh": "FDA 标签档案版本", "en": "FDA label archive version" }, "detail": { "zh": "本页链接 DailyMed SPL v1, published 2026-08-10 的 FDA 标签档案作为可复核阅读入口。现行标签、规格、适应症和安全信息必须另行以目标市场当前文件核对。", "en": "This page links the DailyMed SPL v1, published 2026-08-10 FDA label archive as a traceable reading entry point. Current labeling, strength, indication and safety information require separate verification against the target market’s current document." }, "source": { "id": "src_714e9eb8d87c343c", "label": "DailyMed: CELLCEPT mycophenolate mofetil current U.S. public label", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=37241e87-4af4-4dc3-a1aa-ea6f20d8dc40&version=1", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-26", "reviewedAt": "2026-08-26" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "已链接公开标签档案", "en": "Public label archive linked" }, "detail": { "zh": "仅对应本页所列 FDA 文件。", "en": "Only the FDA document listed on this page is linked." } }, { "market": { "zh": "中国大陆、欧盟、日本", "en": "Mainland China, EU, Japan" }, "status": { "zh": "待逐项建立市场记录", "en": "Market record not established" }, "detail": { "zh": "不从美国标签档案推定当地批准、持有人、规格、供应或可售资格。", "en": "No local approval, holder, strength, supply or sale-eligibility conclusion is inferred from the U.S. label archive." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "标签档案能代表现在的产品信息吗？", "en": "Does a label archive represent current product information?" }, "answer": { "zh": "不能自动代表。档案用于定位来源；需要以目标市场的现行官方标签逐项复核。", "en": "Not automatically. The archive locates a source; each point needs verification against the target market’s current official label." } }, { "question": { "zh": "为什么这里不展示价格或原研/仿制结论？", "en": "Why are price and originator/generic conclusions not shown?" }, "answer": { "zh": "这些结论需要产品、剂型、规格、包装、市场、日期和原始记录分别齐全并经人工审核；单一标签文件不足以支持。", "en": "Those conclusions require separately complete and human-reviewed product, dosage-form, strength, pack, market, date and primary-record fields; one label file is insufficient." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "how-to-read-a-drug-label", "regulatory-sources-first" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/cellcept/", "en": "https://origindrug.com/en/drugs/cellcept/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "avastin", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-28", "status": "published_traceable_archive" }, "names": { "brand": "Avastin", "generic": "贝伐珠单抗", "aliases": [ "bevacizumab" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "肿瘤与血液", "sourceArchiveMarket": "美国 DailyMed 当前公开标签（2025-01 更新；两个准确单剂量瓶包装身份）", "dosageFormClass": "静脉用注射液：100 mg/4 mL 与 400 mg/16 mL（25 mg/mL）单剂量瓶", "dosageFormClassCode": "intravenous_infusion", "route": "静脉输注", "routeCode": "intravenous", "historicalApprovalEntry": "2004（美国公开标签所列初始批准）", "archiveSponsorText": "Genentech / DailyMed（NLM）美国公开标签" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-avastin-bevacizumab-100mg-4ml-single-dose-vial-5024206001", "marketCode": "US", "labelVersion": { "zh": "DailyMed 美国公开标签（Genentech；2025-01 更新）", "en": "DailyMed U.S. public label (Genentech; updated Jan 2025)" }, "dosageForm": { "zh": "AVASTIN 贝伐珠单抗静脉用注射液", "en": "AVASTIN bevacizumab injection for intravenous use" }, "route": { "zh": "稀释后静脉输注（仅为标签产品身份；不是操作指令）", "en": "intravenous infusion after dilution (label identity only; not a procedure instruction)" }, "routeCodes": [ "intravenous_infusion" ], "productCode": "NDC 50242-060-01", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_single_dose_vial", "primaryDisplay": { "zh": "每个单剂量瓶含贝伐珠单抗 100 mg/4 mL（25 mg/mL）；每盒 1 瓶", "en": "Bevacizumab 100 mg/4 mL (25 mg/mL) per single-dose vial; one vial per carton" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=avastin-10.jpg&setid=939b5d1f-9fb2-4499-80ef-0607aa6b114e&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "贝伐珠单抗", "en": "bevacizumab" }, "value": 100, "unit": "mg", "basisCode": "per_single_dose_vial", "basisLabel": { "zh": "每个单剂量瓶的标签总量；不是个人输注量、瓶数、稀释、联用或停药方案", "en": "labelled total per single-dose vial; not an individual's infusion amount, vial count, dilution, combination or stopping plan" } } ], "concentration": null, "container": { "typeCode": "single_dose_vial", "typeLabel": { "zh": "无防腐剂单剂量瓶；未用部分须丢弃", "en": "preservative-free single-dose vial; discard unused portion" }, "fill": { "value": 4, "unit": "mL" }, "countPerPackage": null, "countUnit": null }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-28", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 1, "unit": { "zh": "个单剂量瓶/盒", "en": "single-dose vial per carton" } }, "physicalClues": { "color": { "zh": "澄清至轻微乳光、无色至淡棕色溶液（标签描述）", "en": "clear to slightly opalescent, colourless to pale-brown solution (label description)" }, "shape": { "zh": "4 mL 单剂量玻璃瓶及纸盒", "en": "4 mL single-dose glass vial and carton" }, "imprint": null, "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_df56f94cc69f6fc0", "label": "DailyMed（NLM）：AVASTIN 100 mg/4 mL 单剂量瓶美国公开标签面板（Genentech；2025-01 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=939b5d1f-9fb2-4499-80ef-0607aa6b114e", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-avastin-bevacizumab-400mg-16ml-single-dose-vial-5024206101", "marketCode": "US", "labelVersion": { "zh": "DailyMed 美国公开标签（Genentech；2025-01 更新）", "en": "DailyMed U.S. public label (Genentech; updated Jan 2025)" }, "dosageForm": { "zh": "AVASTIN 贝伐珠单抗静脉用注射液", "en": "AVASTIN bevacizumab injection for intravenous use" }, "route": { "zh": "稀释后静脉输注（仅为标签产品身份；不是操作指令）", "en": "intravenous infusion after dilution (label identity only; not a procedure instruction)" }, "routeCodes": [ "intravenous_infusion" ], "productCode": "NDC 50242-061-01", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_single_dose_vial", "primaryDisplay": { "zh": "每个单剂量瓶含贝伐珠单抗 400 mg/16 mL（25 mg/mL）；每盒 1 瓶", "en": "Bevacizumab 400 mg/16 mL (25 mg/mL) per single-dose vial; one vial per carton" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=avastin-11.jpg&setid=939b5d1f-9fb2-4499-80ef-0607aa6b114e&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "贝伐珠单抗", "en": "bevacizumab" }, "value": 400, "unit": "mg", "basisCode": "per_single_dose_vial", "basisLabel": { "zh": "每个单剂量瓶的标签总量；不是个人输注量、瓶数、稀释、联用或停药方案", "en": "labelled total per single-dose vial; not an individual's infusion amount, vial count, dilution, combination or stopping plan" } } ], "concentration": null, "container": { "typeCode": "single_dose_vial", "typeLabel": { "zh": "无防腐剂单剂量瓶；未用部分须丢弃", "en": "preservative-free single-dose vial; discard unused portion" }, "fill": { "value": 16, "unit": "mL" }, "countPerPackage": null, "countUnit": null }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-28", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 1, "unit": { "zh": "个单剂量瓶/盒", "en": "single-dose vial per carton" } }, "physicalClues": { "color": { "zh": "澄清至轻微乳光、无色至淡棕色溶液（标签描述）", "en": "clear to slightly opalescent, colourless to pale-brown solution (label description)" }, "shape": { "zh": "16 mL 单剂量玻璃瓶及纸盒", "en": "16 mL single-dose glass vial and carton" }, "imprint": null, "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_df56f94cc69f6fc0", "label": "DailyMed（NLM）：AVASTIN 400 mg/16 mL 单剂量瓶美国公开标签面板（Genentech；2025-01 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=939b5d1f-9fb2-4499-80ef-0607aa6b114e", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-avastin-bevacizumab-100mg-4ml-single-dose-vial-5024206001", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=avastin-10.jpg&setid=939b5d1f-9fb2-4499-80ef-0607aa6b114e&type=img", "alt": "AVASTIN 贝伐珠单抗在美国 DailyMed Genentech 公开标签中的 100 mg/4 mL 单剂量瓶纸盒正面图", "archiveMarket": "美国", "labelVersion": "DailyMed 公开标签（Genentech，2025-01 更新）", "presentation": "AVASTIN 注射液：100 mg/4 mL（25 mg/mL），静脉用单剂量瓶纸盒正面图（DailyMed Genentech 公开标签所列）。", "notice": "此为美国 DailyMed Genentech 公开标签中明确对应 AVASTIN、贝伐珠单抗 100 mg/4 mL（25 mg/mL）单剂量瓶的纸盒图，只帮助核对品牌、通用名、剂型、标示浓度、静脉用与来源；不用于鉴定真伪，也不证明 400 mg/16 mL 或其他规格、其他市场标签、当前可得性、原研身份、目标市场批准或可售资格。", "source": { "id": "src_5caab32ce3a2a660", "label": "DailyMed（NLM）：AVASTIN 公开标签（Genentech，2025-01 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=939b5d1f-9fb2-4499-80ef-0607aa6b114e", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "AVASTIN 说明书放大阅读：25 mg/mL 只帮助识别静脉输注瓶", "en": "AVASTIN label reading: 25 mg/mL only helps identify an intravenous-infusion vial" }, "summary": { "zh": "以 DailyMed 当前 AVASTIN 美国公开标签为阅读入口，核对贝伐珠单抗、100 mg/4 mL 与 400 mg/16 mL（25 mg/mL）单剂量瓶和目标市场；不把浓度、瓶数或抗肿瘤方案变成个人输注、联用或停药决定。", "en": "Using the current U.S. DailyMed public label for AVASTIN as an entry point, this checks bevacizumab, 100 mg/4 mL and 400 mg/16 mL (25 mg/mL) single-dose vials and target market; it does not turn concentration, vial count or an oncology regimen into an individual infusion, combination or stopping decision." }, "checks": [ { "zh": "100 mg/4 mL 和 25 mg/mL 是准确单剂量瓶的总含量与浓度线索，不是需要几瓶、余量可否保存或家庭输注说明。", "en": "100 mg/4 mL and 25 mg/mL are total-content and concentration clues for the exact single-dose vial, not a number of vials, permission to save leftovers or home-infusion instructions." }, { "zh": "同为抗血管生成或静脉抗肿瘤药，不表示可自行与化疗、其他靶向药、免疫治疗、抗凝药或补充剂组合、轮换或替代。", "en": "Being an anti-angiogenic or intravenous anticancer medicine does not permit self-combination, alternation or substitution with chemotherapy, another targeted medicine, immunotherapy, anticoagulation or supplements." }, { "zh": "明显出血、突发胸痛或呼吸不适、严重腹痛、伤口异常、严重头痛/神经变化或其他急性问题，应及时使用当地紧急医疗支持并联系治疗团队。", "en": "With marked bleeding, sudden chest pain or breathing trouble, severe abdominal pain, an unusual wound problem, severe headache/neurologic change or another acute concern, use local urgent medical support promptly and contact the treatment team." } ], "source": { "id": "src_df56f94cc69f6fc0", "label": "DailyMed（NLM）：AVASTIN 当前美国公开标签", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=939b5d1f-9fb2-4499-80ef-0607aa6b114e", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "贝伐珠单抗怎样起作用：标签描述其结合 VEGF 并抑制血管生成信号", "en": "How bevacizumab works: the label describes binding VEGF and inhibiting angiogenesis signalling" }, "summary": { "zh": "DailyMed 的 AVASTIN 当前公开标签描述贝伐珠单抗可结合 VEGF，阻止其与血管内皮细胞表面受体结合，从而抑制血管生成。它解释一条肿瘤生物学路径，不判断个人肿瘤是否适用、是否联合化疗、输注剂量或开始、暂停和停用。", "en": "The current DailyMed public label for AVASTIN describes bevacizumab as binding VEGF and preventing its binding to endothelial-cell receptors, thereby inhibiting angiogenesis. It explains one tumour-biology pathway, not individual suitability, chemotherapy combination, infusion dose or a start/hold/stop decision." }, "checks": [ { "zh": "“抗血管生成”不是凭肿瘤名称、影像报告或网络资料自行判断用药的依据。疾病类型、病理/分子资料、既往治疗、手术计划、出血或血栓风险和完整药单须由肿瘤团队整体评估。", "en": "“Anti-angiogenesis” is not a basis for treatment decisions from a tumour name, imaging report or online information. Disease type, pathology/molecular information, prior therapy, surgical plans, bleeding/thrombosis risk and complete medicine list need oncology-team assessment." }, { "zh": "共同影响 VEGF 或都为抗体药物，不表示 AVASTIN 可与另一种靶向药、生物制剂、抗凝药或其他治疗自行叠加、轮换或替代。", "en": "A shared VEGF effect or antibody class does not make AVASTIN self-combinable, alternatable or substitutable with another targeted therapy, biologic, anticoagulant or other treatment." }, { "zh": "标签含有出血、胃肠穿孔、伤口愈合、高血压和其他严重风险警示。出现出血、剧烈腹痛、胸痛、呼吸困难、神经系统异常或其他急性问题时，应立即使用当地肿瘤团队或紧急医疗渠道。", "en": "The label contains warnings about bleeding, GI perforation, wound healing, hypertension and other serious risks. With bleeding, severe abdominal pain, chest pain, breathing trouble, neurologic change or another acute concern, use the local oncology team or emergency pathway immediately." } ], "source": { "id": "src_df56f94cc69f6fc0", "label": "DailyMed（NLM）：AVASTIN 当前美国公开标签（临床药理）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=939b5d1f-9fb2-4499-80ef-0607aa6b114e", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "Avastin", "generic": "贝伐珠单抗", "dosageFormClass": "静脉用注射液：100 mg/4 mL 与 400 mg/16 mL（25 mg/mL）单剂量瓶" }, "labelSource": { "id": "src_df56f94cc69f6fc0", "label": "DailyMed（NLM）：AVASTIN 贝伐珠单抗当前美国公开标签（Genentech；2025-01 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=939b5d1f-9fb2-4499-80ef-0607aa6b114e", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "productRoutes": [ { "source": { "id": "src_df56f94cc69f6fc0", "label": "DailyMed（NLM）：AVASTIN 贝伐珠单抗当前美国公开标签（Genentech；2025-01 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=939b5d1f-9fb2-4499-80ef-0607aa6b114e", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_21b7725287c2a9f6", "label": "FDA：AVASTIN 2014 美国历史标签（BLA 125085）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125085s305lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "DailyMed 的 AVASTIN（bevacizumab）当前美国公开标签列示 100 mg/4 mL 与 400 mg/16 mL 两个 25 mg/mL 单剂量瓶。本页把浓度、总体积、NDC、包装与来源分开呈现；不把浓度或瓶数变成个人输注、联用、停药或购买结论。", "history": "两个单剂量瓶共享浓度但总体积与总毫克数不同；不能只看品牌或 25 mg/mL 就视作同一包装。市场记录、配制与给药条件须按目标市场现行文件逐项复核。", "sourceDocuments": [ { "id": "src_df56f94cc69f6fc0", "label": "DailyMed（NLM）：AVASTIN 贝伐珠单抗当前美国公开标签（Genentech；2025-01 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=939b5d1f-9fb2-4499-80ef-0607aa6b114e", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_21b7725287c2a9f6", "label": "FDA：AVASTIN 2014 美国历史标签（BLA 125085）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125085s305lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_5ed30b676fbb9773", "label": "FDA Drugs@FDA 官方检索入口", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_lookup_entry", "documentKind": "regulatory_lookup", "market": "US", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } ], "applicationNumber": "BLA 125085", "approvalTimeline": [ { "date": "DailyMed 当前公开标签，2025-01 更新", "title": { "zh": "当前美国公开标签的日期记录", "en": "Dated current U.S. public-label record" }, "detail": { "zh": "本页链接 DailyMed 当前公开标签，2025-01 更新 的当前美国公开标签，作为放大阅读和逐项核对入口。它不替代目标市场当日的批准、供应、适应症、规格或个体化用药判断。", "en": "This page links the current U.S. public label dated DailyMed 当前公开标签，2025-01 更新 as an enlarged-reading and item-by-item checking entry point. It does not replace same-day verification of approval, supply, indication, strength or individual use in the target market." }, "source": { "id": "src_df56f94cc69f6fc0", "label": "DailyMed: current AVASTIN U.S. public label", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=939b5d1f-9fb2-4499-80ef-0607aa6b114e", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "已链接当前公开标签", "en": "Current public label linked" }, "detail": { "zh": "仅对应本页所列的美国公开标签；不据此推定库存、可售资格或其他市场状态。", "en": "Only the U.S. public label listed on this page is linked; no stock, sale-eligibility or other-market conclusion is inferred." } }, { "market": { "zh": "中国大陆、欧盟、日本", "en": "Mainland China, EU, Japan" }, "status": { "zh": "待逐项建立市场记录", "en": "Market record not established" }, "detail": { "zh": "不从美国公开标签推定当地批准、持有人、规格、供应或可售资格。", "en": "No local approval, holder, strength, supply or sale-eligibility conclusion is inferred from the U.S. public label." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "当前美国标签能代表其他国家或地区吗？", "en": "Does a current U.S. label represent another country or region?" }, "answer": { "zh": "不能。它是逐项阅读入口；品牌、剂型、规格、可得性和安全信息仍须以目标市场的现行官方文件核对。", "en": "No. It is an item-by-item reading entry point; brand, dosage form, strength, availability and safety information still require checking against the target market's current official document." } }, { "question": { "zh": "为什么这里不展示价格或原研/仿制结论？", "en": "Why are price and originator/generic conclusions not shown?" }, "answer": { "zh": "这些结论需要产品、剂型、规格、包装、市场、日期和原始记录分别齐全并经人工审核；单一标签文件不足以支持。", "en": "Those conclusions require separately complete and human-reviewed product, dosage-form, strength, pack, market, date and primary-record fields; one label file is insufficient." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "dosage-forms-are-part-of-medicine-identity", "medicine-label-for-everyday-questions", "how-to-read-a-drug-label" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/avastin/", "en": "https://origindrug.com/en/drugs/avastin/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "keytruda", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-15", "status": "published_traceable_archive" }, "names": { "brand": "Keytruda", "generic": "帕博利珠单抗", "aliases": [ "pembrolizumab", "可瑞达", "K药", "K 药" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": { "value": "可瑞达®（常见俗称：K 药）", "status": "discovery_cue_requires_target_market_verification", "source": { "id": "src_a7c6f20b63b39c7f", "label": "默沙东中国：帕博利珠单抗（商品名可瑞达®）在华获批公开资料", "url": "https://www.msdchina.com.cn/2024/09/14/company_news_2024-09-14/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "first_party_release", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" } } }, "identity": { "therapeuticArea": "肿瘤与血液", "sourceArchiveMarket": "美国 DailyMed 当前公开标签（2026-07-10 生效）及 FDA 监管档案", "dosageFormClass": "静脉输注用注射液：100 mg/4 mL（25 mg/mL）单剂量瓶；同一 SPL 另保留 50 mg 冻干粉展示面板，须与主规格分开阅读", "dosageFormClassCode": "intravenous_infusion", "route": "静脉输注", "routeCode": "intravenous", "historicalApprovalEntry": "2014（FDA 标签所列美国初始批准）", "archiveSponsorText": "Merck Sharp & Dohme / DailyMed 当前美国公开标签；FDA 监管档案" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-keytruda-injection-100mg-4ml-ndc-0006-3026-02", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（2026-07-10 生效）", "en": "Current U.S. DailyMed public label (effective 10 Jul 2026)" }, "dosageForm": { "zh": "KEYTRUDA 帕博利珠单抗注射液", "en": "KEYTRUDA pembrolizumab injection" }, "route": { "zh": "静脉输注用", "en": "for intravenous infusion" }, "routeCodes": [ "intravenous_infusion" ], "productCode": "NDC 0006-3026-02", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_vial", "primaryDisplay": { "zh": "100 mg/4 mL（25 mg/mL）；单剂量瓶；1 瓶/盒", "en": "100 mg/4 mL (25 mg/mL); single-dose vial; one vial per carton" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=keytruda-08.jpg&setid=9333c79b-d487-4538-a9f0-71b91a02b287&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "帕博利珠单抗", "en": "pembrolizumab" }, "value": 100, "unit": "mg", "basisCode": "per_vial", "basisLabel": { "zh": "每个 4 mL 单剂量瓶的标签标示量", "en": "labelled amount per 4 mL single-dose vial" } } ], "concentration": null, "container": { "typeCode": "single_dose_vial", "typeLabel": { "zh": "4 mL 单剂量瓶", "en": "4 mL single-dose vial" }, "fill": { "value": 4, "unit": "mL" }, "countPerPackage": null, "countUnit": null }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-28", "currentLabelDisplayed": true, "ndcDirectoryListed": false, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 1, "unit": { "zh": "瓶/盒", "en": "vial per carton" } }, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_da1d50934ec1a937", "label": "DailyMed（NLM）：KEYTRUDA 100 mg/4 mL、NDC 0006-3026-02 当前美国标签面板（2026-07-10 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=9333c79b-d487-4538-a9f0-71b91a02b287", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-keytruda-injection-100mg-4ml-ndc-0006-3026-02", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=keytruda-08.jpg&setid=9333c79b-d487-4538-a9f0-71b91a02b287&type=img", "alt": "KEYTRUDA 帕博利珠单抗在美国 DailyMed Merck 公开标签中的 100 mg/4 mL 单剂量瓶纸盒展开图（NDC 0006-3026-02）", "archiveMarket": "美国", "labelVersion": "DailyMed 公开标签（Merck Sharp & Dohme，2026-07 更新；包装图稿 2025）", "presentation": "KEYTRUDA 注射液：100 mg/4 mL（25 mg/mL），静脉输注用单剂量瓶纸盒展开图，NDC 0006-3026-02（DailyMed Merck 公开标签所列）。", "notice": "此图对应当前公开标签剂型章节所列 KEYTRUDA 100 mg/4 mL（25 mg/mL）单剂量瓶；同一份 SPL 仍包含 50 mg 冻干粉的另一张包装图，二者不得混作同一规格。图片只帮助核对品牌、通用名、剂型、浓度、包装代码和来源；不用于鉴定真伪，也不证明其他市场标签、当前可得性、原研身份、目标市场批准或可售资格。", "source": { "id": "src_badb7cf312d9bb57", "label": "DailyMed（NLM）：KEYTRUDA 公开标签（Merck Sharp & Dohme，2026-07 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=9333c79b-d487-4538-a9f0-71b91a02b287", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "KEYTRUDA 说明书放大阅读：瓶身的 mg/mL 是输注制剂身份，不是家庭用量", "en": "KEYTRUDA label reading: mg/mL on a vial identifies an infusion product, not an at-home amount" }, "summary": { "zh": "本模块以 Merck Sharp & Dohme LLC 的美国 DailyMed 2026-07 KEYTRUDA 公开标签为阅读入口，帮助核对 KEYTRUDA、帕博利珠单抗、静脉用注射剂、100 mg/4 mL（25 mg/mL）单剂量瓶、包装和目标市场；它不把瓶身浓度、输注安排、检测术语或标签风险文字变成个人治疗方案。", "en": "This module uses Merck Sharp & Dohme LLC's July 2026 U.S. DailyMed public label for KEYTRUDA as a reading entry point. It helps check KEYTRUDA, pembrolizumab, injection for intravenous use, a 100 mg/4 mL (25 mg/mL) single-dose vial, package and target market; it does not turn vial concentration, infusion scheduling, test terminology or label risk wording into an individual treatment plan." }, "checks": [ { "zh": "100 mg/4 mL 与 25 mg/mL 是这支准确单剂量瓶的总含量和浓度线索，不是“该输多少”“能否分给两个人”或“能否在家处理”的答案。静脉输注制剂的配制、稀释、输注、剩余处置和每次安排必须由治疗机构按现行标签与处方负责。", "en": "100 mg/4 mL and 25 mg/mL are total-content and concentration clues for this exact single-dose vial, not answers to “how much to infuse,” “can it be shared,” or “can it be handled at home.” Preparation, dilution, infusion, remaining-product handling and each visit plan for an intravenous product belong to the treating facility under the current label and prescription." }, { "zh": "同为“免疫治疗”、PD-1/PD-L1 抗体或静脉用药，不表示 KEYTRUDA 可与 OPDIVO、化疗、靶向药、激素或其他生物制剂自行叠加、轮换、漏用后补回或替代。肿瘤类型、病理/分子检测、既往方案、器官功能和全套药物清单必须由肿瘤团队统一核对。", "en": "Being called immunotherapy, a PD-1/PD-L1 antibody or an intravenous medicine does not make KEYTRUDA self-combinable, alternatable, catch-up replaceable or substitutable with OPDIVO, chemotherapy, targeted therapy, steroids or another biologic. Tumour type, pathology/molecular testing, prior regimen, organ function and the full medicine list require integrated oncology-team review." }, { "zh": "标签提示免疫介导反应可涉及肺、肠道、肝脏、内分泌器官、肾脏、皮肤等，也提示输注相关反应。新的或加重的呼吸困难、持续腹泻、黄疸样变化、异常乏力/意识变化、尿量变化、严重皮疹、发热寒战或其他急性问题，应及时联系治疗团队或使用当地紧急医疗支持，而不是等下一次输注时再自行判断。", "en": "The label notes immune-mediated reactions that may involve lungs, bowel, liver, endocrine organs, kidneys and skin, as well as infusion-related reactions. New or worsening breathing difficulty, persistent diarrhoea, jaundice-like changes, unusual fatigue/mental-status change, changed urine output, severe rash, fever/chills or another acute concern needs prompt contact with the treatment team or local urgent medical support rather than waiting to self-assess at the next infusion." }, { "zh": "PD-L1、MSI-H、dMMR、TMB-H 等检测名称出现在部分适应症的标签条件中，但看到一个检测名、数值或网络解读并不能确认某个人适合 KEYTRUDA。样本、方法、疾病场景、合并方案及目标市场现行标签都需要由肿瘤团队解释。", "en": "Test names such as PD-L1, MSI-H, dMMR and TMB-H appear in label conditions for some indications, but seeing a test name, value or online interpretation cannot confirm that an individual fits KEYTRUDA. Specimen, method, disease setting, combination plan and the current target-market label require oncology-team interpretation." } ], "source": { "id": "src_badb7cf312d9bb57", "label": "DailyMed（NLM）：KEYTRUDA 公开标签（Merck Sharp & Dohme，2026-07 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=9333c79b-d487-4538-a9f0-71b91a02b287", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "帕博利珠单抗怎样起作用：标签描述其阻断 PD-1 与 PD-L1/PD-L2 的结合", "en": "How pembrolizumab works: the label describes blocking PD-1 binding to PD-L1/PD-L2" }, "summary": { "zh": "FDA 的 KEYTRUDA 标签描述帕博利珠单抗与 PD-1 受体结合，阻断其与 PD-L1 和 PD-L2 的相互作用，从而解除 PD-1 通路介导的 T 细胞反应抑制。它解释免疫检查点路径，不预测个人获益，也不决定检测条件、分期、联合方案或输注频率。", "en": "The FDA KEYTRUDA label describes pembrolizumab as binding PD-1 and blocking interaction with PD-L1/PD-L2, releasing PD-1-pathway-mediated inhibition of T-cell responses. It explains an immune-checkpoint pathway, not individual benefit, testing criteria, stage, combination plan or infusion frequency." }, "checks": [ { "zh": "“PD-1/PD-L1”不是自行解读检测结果或选择免疫治疗的工具。检测方法、样本、评分、疾病类型、既往治疗和所在市场现行标签必须由肿瘤团队结合完整病理资料确认。", "en": "“PD-1/PD-L1” is not a tool for self-interpreting a test or selecting immunotherapy. Test method, specimen, score, disease type, prior therapy and current target-market label must be confirmed by an oncology team with the full pathology record." }, { "zh": "同属免疫检查点药物，或都写“免疫治疗”，不表示 KEYTRUDA 能与另一种免疫药、靶向药、化疗、激素或补充剂自行叠加、轮换或替代。", "en": "Being an immune-checkpoint medicine, or both being called immunotherapy, does not make KEYTRUDA self-combinable, alternatable or substitutable with another immune medicine, targeted therapy, chemotherapy, steroid or supplement." }, { "zh": "出现新发或加重的呼吸困难、持续腹泻、黄疸、明显乏力、严重皮疹、视力/神经变化或其他急性问题时，应及时联系治疗团队或紧急医疗支持。", "en": "With new or worsening breathing trouble, persistent diarrhoea, jaundice, marked weakness, severe rash, visual/neurologic change or another acute concern, contact the treatment team or urgent medical support promptly." } ], "source": { "id": "src_299287440a5b0890", "label": "FDA：KEYTRUDA 2026-07 美国标签（临床药理）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/125514s194lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "Keytruda", "generic": "帕博利珠单抗", "dosageFormClass": "静脉输注用注射液：100 mg/4 mL（25 mg/mL）单剂量瓶；同一 SPL 另保留 50 mg 冻干粉展示面板，须与主规格分开阅读" }, "labelSource": { "id": "src_299287440a5b0890", "label": "FDA：KEYTRUDA 2026-07 美国标签（BLA 125514，S-194）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/125514s194lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "productRoutes": [ { "source": { "id": "src_299287440a5b0890", "label": "FDA：KEYTRUDA 2026-07 美国标签（BLA 125514，S-194）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/125514s194lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "DailyMed 的 KEYTRUDA（pembrolizumab）2026 当前美国标签在“剂型与规格”中列出 100 mg/4 mL（25 mg/mL）单剂量瓶。本页以这一现行规格的精确面板为主展示，并把同一 SPL 仍保留的 50 mg 冻干粉展示面板视作另一产品呈现，不混作同一规格。", "history": "静脉输注产品的完整身份还取决于规格、配制与给药要求、市场和标签版本；本页面不提供诊疗、处方、替代或购买结论。", "sourceDocuments": [ { "id": "src_299287440a5b0890", "label": "FDA：KEYTRUDA 2026-07 美国标签（BLA 125514，S-194）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/125514s194lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_5ed30b676fbb9773", "label": "FDA Drugs@FDA 官方检索入口", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_lookup_entry", "documentKind": "regulatory_lookup", "market": "US", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } ], "applicationNumber": "BLA 125514", "approvalTimeline": [ { "date": "2014", "title": { "zh": "FDA 标签所列美国初始批准年份", "en": "Initial U.S. approval year listed in the FDA label" }, "detail": { "zh": "本页链接的 FDA 标签档案列示 Initial U.S. Approval: 2014。该历史定位不等同于当前批准、可得性、持有人或其他市场状态。", "en": "The FDA label archive linked here lists Initial U.S. Approval: 2014. This historical locator is not a conclusion about current approval, availability, holder or another market." }, "source": { "id": "src_299287440a5b0890", "label": "FDA: KEYTRUDA prescribing information", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/125514s194lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, { "date": "2026-07", "title": { "zh": "FDA 标签档案版本", "en": "FDA label archive version" }, "detail": { "zh": "本页链接 2026-07 的 FDA 标签档案作为可复核阅读入口。现行标签、规格、适应症和安全信息必须另行以目标市场当前文件核对。", "en": "This page links the 2026-07 FDA label archive as a traceable reading entry point. Current labeling, strength, indication and safety information require separate verification against the target market’s current document." }, "source": { "id": "src_299287440a5b0890", "label": "FDA: KEYTRUDA prescribing information", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/125514s194lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "已链接公开标签档案", "en": "Public label archive linked" }, "detail": { "zh": "仅对应本页所列 FDA 文件。", "en": "Only the FDA document listed on this page is linked." } }, { "market": { "zh": "中国大陆、欧盟、日本", "en": "Mainland China, EU, Japan" }, "status": { "zh": "待逐项建立市场记录", "en": "Market record not established" }, "detail": { "zh": "不从美国标签档案推定当地批准、持有人、规格、供应或可售资格。", "en": "No local approval, holder, strength, supply or sale-eligibility conclusion is inferred from the U.S. label archive." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "标签档案能代表现在的产品信息吗？", "en": "Does a label archive represent current product information?" }, "answer": { "zh": "不能自动代表。档案用于定位来源；需要以目标市场的现行官方标签逐项复核。", "en": "Not automatically. The archive locates a source; each point needs verification against the target market’s current official label." } }, { "question": { "zh": "为什么这里不展示价格或原研/仿制结论？", "en": "Why are price and originator/generic conclusions not shown?" }, "answer": { "zh": "这些结论需要产品、剂型、规格、包装、市场、日期和原始记录分别齐全并经人工审核；单一标签文件不足以支持。", "en": "Those conclusions require separately complete and human-reviewed product, dosage-form, strength, pack, market, date and primary-record fields; one label file is insufficient." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "dosage-forms-are-part-of-medicine-identity", "medicine-label-for-everyday-questions", "how-to-read-a-drug-label" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/keytruda/", "en": "https://origindrug.com/en/drugs/keytruda/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "opdivo", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-28", "status": "published_traceable_archive" }, "names": { "brand": "Opdivo", "generic": "纳武利尤单抗", "aliases": [ "nivolumab" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "肿瘤与血液", "sourceArchiveMarket": "美国 DailyMed 当前公开标签（2026-05 更新；四个准确单剂量瓶包装身份）", "dosageFormClass": "静脉输注用注射剂：40 mg/4 mL、100 mg/10 mL、120 mg/12 mL、240 mg/24 mL 单剂量瓶", "dosageFormClassCode": "intravenous_infusion", "route": "静脉输注", "routeCode": "intravenous", "historicalApprovalEntry": "2014（美国公开标签所列初始批准）", "archiveSponsorText": "Bristol Myers Squibb / DailyMed（NLM）美国公开标签" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-opdivo-nivolumab-40mg-4ml-single-dose-vial-0003377211", "marketCode": "US", "labelVersion": { "zh": "DailyMed 美国公开标签（Bristol Myers Squibb；2026-05 更新）", "en": "DailyMed U.S. public label (Bristol Myers Squibb; updated May 2026)" }, "dosageForm": { "zh": "OPDIVO 纳武利尤单抗静脉输注用注射液", "en": "OPDIVO nivolumab injection for intravenous infusion" }, "route": { "zh": "静脉输注（仅为标签产品身份；不是操作指令）", "en": "intravenous infusion (label identity only; not a procedure instruction)" }, "routeCodes": [ "intravenous_infusion" ], "productCode": "NDC 0003-3772-11", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_single_dose_vial", "primaryDisplay": { "zh": "每个单剂量瓶含纳武利尤单抗 40 mg/4 mL（10 mg/mL）；每盒 1 瓶", "en": "Nivolumab 40 mg/4 mL (10 mg/mL) per single-dose vial; one vial per carton" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=opdivo-40mg-4ml-ctn.jpg&setid=f570b9c4-6846-4de2-abfa-4d0a4ae4e394&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "纳武利尤单抗", "en": "nivolumab" }, "value": 40, "unit": "mg", "basisCode": "per_single_dose_vial", "basisLabel": { "zh": "每个单剂量瓶的标签总量；不是个人输注量、瓶数、间隔、联合或换药方案", "en": "labelled total per single-dose vial; not an individual's infusion amount, vial count, interval, combination or switching plan" } } ], "concentration": null, "container": { "typeCode": "single_dose_vial", "typeLabel": { "zh": "单剂量瓶；未用部分须丢弃", "en": "single-dose vial; discard unused portion" }, "fill": { "value": 4, "unit": "mL" }, "countPerPackage": null, "countUnit": null }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-28", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 1, "unit": { "zh": "个单剂量瓶/盒", "en": "single-dose vial per carton" } }, "physicalClues": { "color": { "zh": "澄清至乳光、无色至淡黄色溶液（标签描述）", "en": "clear to opalescent, colourless to pale-yellow solution (label description)" }, "shape": { "zh": "4 mL 单剂量玻璃瓶及纸盒", "en": "4 mL single-dose glass vial and carton" }, "imprint": null, "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_ff06f39a33bac3c6", "label": "DailyMed（NLM）：OPDIVO 40 mg/4 mL 单剂量瓶美国公开标签面板（Bristol Myers Squibb；2026-05 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=f570b9c4-6846-4de2-abfa-4d0a4ae4e394", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-opdivo-nivolumab-100mg-10ml-single-dose-vial-0003377412", "marketCode": "US", "labelVersion": { "zh": "DailyMed 美国公开标签（Bristol Myers Squibb；2026-05 更新）", "en": "DailyMed U.S. public label (Bristol Myers Squibb; updated May 2026)" }, "dosageForm": { "zh": "OPDIVO 纳武利尤单抗静脉输注用注射液", "en": "OPDIVO nivolumab injection for intravenous infusion" }, "route": { "zh": "静脉输注（仅为标签产品身份；不是操作指令）", "en": "intravenous infusion (label identity only; not a procedure instruction)" }, "routeCodes": [ "intravenous_infusion" ], "productCode": "NDC 0003-3774-12", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_single_dose_vial", "primaryDisplay": { "zh": "每个单剂量瓶含纳武利尤单抗 100 mg/10 mL（10 mg/mL）；每盒 1 瓶", "en": "Nivolumab 100 mg/10 mL (10 mg/mL) per single-dose vial; one vial per carton" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=opdivo-100mg-10ml-ctn.jpg&setid=f570b9c4-6846-4de2-abfa-4d0a4ae4e394&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "纳武利尤单抗", "en": "nivolumab" }, "value": 100, "unit": "mg", "basisCode": "per_single_dose_vial", "basisLabel": { "zh": "每个单剂量瓶的标签总量；不是个人输注量、瓶数、间隔、联合或换药方案", "en": "labelled total per single-dose vial; not an individual's infusion amount, vial count, interval, combination or switching plan" } } ], "concentration": null, "container": { "typeCode": "single_dose_vial", "typeLabel": { "zh": "单剂量瓶；未用部分须丢弃", "en": "single-dose vial; discard unused portion" }, "fill": { "value": 10, "unit": "mL" }, "countPerPackage": null, "countUnit": null }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-28", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 1, "unit": { "zh": "个单剂量瓶/盒", "en": "single-dose vial per carton" } }, "physicalClues": { "color": { "zh": "澄清至乳光、无色至淡黄色溶液（标签描述）", "en": "clear to opalescent, colourless to pale-yellow solution (label description)" }, "shape": { "zh": "10 mL 单剂量玻璃瓶及纸盒", "en": "10 mL single-dose glass vial and carton" }, "imprint": null, "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_ff06f39a33bac3c6", "label": "DailyMed（NLM）：OPDIVO 100 mg/10 mL 单剂量瓶美国公开标签面板（Bristol Myers Squibb；2026-05 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=f570b9c4-6846-4de2-abfa-4d0a4ae4e394", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-opdivo-nivolumab-120mg-12ml-single-dose-vial-0003375614", "marketCode": "US", "labelVersion": { "zh": "DailyMed 美国公开标签（Bristol Myers Squibb；2026-05 更新）", "en": "DailyMed U.S. public label (Bristol Myers Squibb; updated May 2026)" }, "dosageForm": { "zh": "OPDIVO 纳武利尤单抗静脉输注用注射液", "en": "OPDIVO nivolumab injection for intravenous infusion" }, "route": { "zh": "静脉输注（仅为标签产品身份；不是操作指令）", "en": "intravenous infusion (label identity only; not a procedure instruction)" }, "routeCodes": [ "intravenous_infusion" ], "productCode": "NDC 0003-3756-14", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_single_dose_vial", "primaryDisplay": { "zh": "每个单剂量瓶含纳武利尤单抗 120 mg/12 mL（10 mg/mL）；每盒 1 瓶", "en": "Nivolumab 120 mg/12 mL (10 mg/mL) per single-dose vial; one vial per carton" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=opdivo-120mg-12ml-ctn.jpg&setid=f570b9c4-6846-4de2-abfa-4d0a4ae4e394&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "纳武利尤单抗", "en": "nivolumab" }, "value": 120, "unit": "mg", "basisCode": "per_single_dose_vial", "basisLabel": { "zh": "每个单剂量瓶的标签总量；不是个人输注量、瓶数、间隔、联合或换药方案", "en": "labelled total per single-dose vial; not an individual's infusion amount, vial count, interval, combination or switching plan" } } ], "concentration": null, "container": { "typeCode": "single_dose_vial", "typeLabel": { "zh": "单剂量瓶；未用部分须丢弃", "en": "single-dose vial; discard unused portion" }, "fill": { "value": 12, "unit": "mL" }, "countPerPackage": null, "countUnit": null }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-28", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 1, "unit": { "zh": "个单剂量瓶/盒", "en": "single-dose vial per carton" } }, "physicalClues": { "color": { "zh": "澄清至乳光、无色至淡黄色溶液（标签描述）", "en": "clear to opalescent, colourless to pale-yellow solution (label description)" }, "shape": { "zh": "12 mL 单剂量玻璃瓶及纸盒", "en": "12 mL single-dose glass vial and carton" }, "imprint": null, "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_ff06f39a33bac3c6", "label": "DailyMed（NLM）：OPDIVO 120 mg/12 mL 单剂量瓶美国公开标签面板（Bristol Myers Squibb；2026-05 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=f570b9c4-6846-4de2-abfa-4d0a4ae4e394", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-opdivo-nivolumab-240mg-24ml-single-dose-vial-0003373413", "marketCode": "US", "labelVersion": { "zh": "DailyMed 美国公开标签（Bristol Myers Squibb；2026-05 更新）", "en": "DailyMed U.S. public label (Bristol Myers Squibb; updated May 2026)" }, "dosageForm": { "zh": "OPDIVO 纳武利尤单抗静脉输注用注射液", "en": "OPDIVO nivolumab injection for intravenous infusion" }, "route": { "zh": "静脉输注（仅为标签产品身份；不是操作指令）", "en": "intravenous infusion (label identity only; not a procedure instruction)" }, "routeCodes": [ "intravenous_infusion" ], "productCode": "NDC 0003-3734-13", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_single_dose_vial", "primaryDisplay": { "zh": "每个单剂量瓶含纳武利尤单抗 240 mg/24 mL（10 mg/mL）；每盒 1 瓶", "en": "Nivolumab 240 mg/24 mL (10 mg/mL) per single-dose vial; one vial per carton" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=opdivo-240mg-24ml-ctn.jpg&setid=f570b9c4-6846-4de2-abfa-4d0a4ae4e394&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "纳武利尤单抗", "en": "nivolumab" }, "value": 240, "unit": "mg", "basisCode": "per_single_dose_vial", "basisLabel": { "zh": "每个单剂量瓶的标签总量；不是个人输注量、瓶数、间隔、联合或换药方案", "en": "labelled total per single-dose vial; not an individual's infusion amount, vial count, interval, combination or switching plan" } } ], "concentration": null, "container": { "typeCode": "single_dose_vial", "typeLabel": { "zh": "单剂量瓶；未用部分须丢弃", "en": "single-dose vial; discard unused portion" }, "fill": { "value": 24, "unit": "mL" }, "countPerPackage": null, "countUnit": null }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-28", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 1, "unit": { "zh": "个单剂量瓶/盒", "en": "single-dose vial per carton" } }, "physicalClues": { "color": { "zh": "澄清至乳光、无色至淡黄色溶液（标签描述）", "en": "clear to opalescent, colourless to pale-yellow solution (label description)" }, "shape": { "zh": "24 mL 单剂量玻璃瓶及纸盒", "en": "24 mL single-dose glass vial and carton" }, "imprint": null, "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_ff06f39a33bac3c6", "label": "DailyMed（NLM）：OPDIVO 240 mg/24 mL 单剂量瓶美国公开标签面板（Bristol Myers Squibb；2026-05 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=f570b9c4-6846-4de2-abfa-4d0a4ae4e394", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-opdivo-nivolumab-40mg-4ml-single-dose-vial-0003377211", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=opdivo-40mg-4ml-ctn.jpg&setid=f570b9c4-6846-4de2-abfa-4d0a4ae4e394&type=img", "alt": "OPDIVO 纳武利尤单抗在美国 DailyMed Bristol Myers Squibb 公开标签中的 40 mg/4 mL 纸盒展开图", "archiveMarket": "美国", "labelVersion": "DailyMed 公开标签（Bristol Myers Squibb，2026-05 更新）", "presentation": "OPDIVO 注射液：40 mg/4 mL（10 mg/mL）单剂量瓶纸盒展开图（DailyMed Bristol Myers Squibb 公开标签所列）。", "notice": "此为美国 DailyMed Bristol Myers Squibb 公开标签中明确对应 OPDIVO、纳武利尤单抗 40 mg/4 mL（10 mg/mL）单剂量瓶的纸盒展开图，只帮助核对品牌、通用名、剂型、标示浓度、单剂量瓶和来源；不用于鉴定真伪，也不证明其他规格、其他给药形式、其他市场标签、当前可得性、原研身份、目标市场批准或可售资格。", "source": { "id": "src_4c881dfa94de0be6", "label": "DailyMed（NLM）：OPDIVO 公开标签（Bristol Myers Squibb，2026-05 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=f570b9c4-6846-4de2-abfa-4d0a4ae4e394", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "OPDIVO 说明书放大阅读：单剂量瓶的 mg/mL 只用于核对输注产品身份", "en": "OPDIVO label reading: mg/mL on a single-dose vial only helps identify an infusion product" }, "summary": { "zh": "本模块以 FDA 2026-05 OPDIVO 美国标签为阅读入口，帮助核对 OPDIVO、纳武利尤单抗、静脉用注射剂、单剂量瓶及目标市场；它不把瓶身的 10 mg/mL、不同瓶装规格、治疗间隔、联合方案或标签风险文字变成个人输注、居家处理或换药方案。", "en": "This module uses the FDA May 2026 U.S. OPDIVO label as a reading entry point. It helps check OPDIVO, nivolumab, injection for intravenous use, single-dose vials and target market; it does not turn a vial's 10 mg/mL, different vial presentations, treatment intervals, combination regimens or label risk wording into an individual infusion, home-handling or switching plan." }, "checks": [ { "zh": "标签列示的 40 mg/4 mL、100 mg/10 mL、120 mg/12 mL、240 mg/24 mL 都是 10 mg/mL 单剂量瓶的产品身份线索。它们不是可自行换算的“几瓶”、可留存的余量或家庭输注指示；配制、稀释、输注和剩余处置应由治疗机构按现行标签与处方执行。", "en": "The label's 40 mg/4 mL, 100 mg/10 mL, 120 mg/12 mL and 240 mg/24 mL are product-identity clues for 10 mg/mL single-dose vials. They are not self-convertible “number of vials,” saved leftovers or home-infusion instructions; preparation, dilution, infusion and remaining-product handling belong to the treating facility under the current label and prescription." }, { "zh": "与 KEYTRUDA 或其他 PD-1/PD-L1 药有相近靶点，或同为静脉用药，不表示可以自行叠加、交替、漏用后补回、由一支换成另一支，或与化疗、伊匹木单抗、靶向药、激素和补充剂随意合用。具体肿瘤、检查、既往方案、器官功能和完整药单必须由肿瘤团队核对。", "en": "A related target to KEYTRUDA or another PD-1/PD-L1 medicine, or being an intravenous product, does not permit self-combination, alternation, catch-up use, vial-to-vial substitution or casual co-use with chemotherapy, ipilimumab, targeted therapy, steroids or supplements. Exact tumour, testing, prior regimen, organ function and the full medicine list require oncology-team review." }, { "zh": "标签提示免疫介导反应可累及肺、肠道、肝脏、内分泌器官、肾脏和皮肤，并有输注相关反应的提示。新的或加重的呼吸困难、持续腹泻、黄疸样变化、异常乏力/意识变化、尿量变化、严重皮疹、发热寒战或其他急性问题，应及时联系治疗团队或使用当地紧急医疗支持。", "en": "The label notes immune-mediated reactions that may involve lungs, bowel, liver, endocrine organs, kidneys and skin, and warns about infusion-related reactions. New or worsening breathing difficulty, persistent diarrhoea, jaundice-like changes, unusual fatigue/mental-status change, changed urine output, severe rash, fever/chills or another acute concern needs prompt contact with the treatment team or local urgent medical support." }, { "zh": "PD-L1、MSI-H、dMMR、EGFR、ALK 等术语在某些疾病场景和标签条件中出现，但不构成自行选择 OPDIVO 或推断联合方案的依据。检测样本、方法、疾病阶段、具体适应症与目标市场现行标签必须由团队解释。", "en": "Terms such as PD-L1, MSI-H, dMMR, EGFR and ALK appear in some disease settings and label conditions, but do not support self-selecting OPDIVO or inferring a combination plan. Test specimen, method, disease stage, exact indication and the current target-market label require team interpretation." } ], "source": { "id": "src_ff06f39a33bac3c6", "label": "DailyMed（NLM）：OPDIVO 当前美国公开标签", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=f570b9c4-6846-4de2-abfa-4d0a4ae4e394", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "纳武利尤单抗怎样起作用：标签描述其阻断 PD-1 与 PD-L1/PD-L2 的相互作用", "en": "How nivolumab works: the label describes blocking PD-1 interactions with PD-L1/PD-L2" }, "summary": { "zh": "DailyMed 的 OPDIVO 当前公开标签描述纳武利尤单抗与 PD-1 受体结合，阻断 PD-1 与 PD-L1/PD-L2 的相互作用，从而解除对 T 细胞反应的抑制。它是机制概述，不判断个人疾病是否适用、联合方案、输注安排或治疗持续时间。", "en": "The current DailyMed public label for OPDIVO describes nivolumab as binding PD-1 and blocking PD-1 interaction with PD-L1/PD-L2, releasing inhibition of T-cell responses. It is a mechanism overview, not a decision about individual suitability, combination, infusion schedule or duration." }, "checks": [ { "zh": "与 KEYTRUDA 或其他 PD-1/PD-L1 药物有相近靶点，不表示可以在同一疗程自行叠加、交替、换算或从一种产品直接改为另一种。", "en": "A related target to KEYTRUDA or another PD-1/PD-L1 medicine does not permit self-combination, alternation, conversion or direct switching within a course." }, { "zh": "机制不能预测哪位患者会获益，也不能替代对免疫相关不良反应、既往自身免疫问题、感染风险、器官功能和完整药单的评估。", "en": "Mechanism cannot predict who will benefit or replace assessment of immune-related adverse reactions, prior autoimmune concerns, infection risk, organ function and the complete medicine list." }, { "zh": "出现新的或加重的呼吸困难、腹泻、黄疸、严重皮疹、内分泌相关症状、视力/神经变化或其他急性问题时，应及时联系当地治疗团队或紧急医疗支持。", "en": "With new or worsening breathing trouble, diarrhoea, jaundice, severe rash, endocrine-related symptoms, visual/neurologic change or another acute concern, contact the local treatment team or urgent medical support promptly." } ], "source": { "id": "src_ff06f39a33bac3c6", "label": "DailyMed（NLM）：OPDIVO 当前美国公开标签（临床药理）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=f570b9c4-6846-4de2-abfa-4d0a4ae4e394", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "Opdivo", "generic": "纳武利尤单抗", "dosageFormClass": "静脉输注用注射剂：40 mg/4 mL、100 mg/10 mL、120 mg/12 mL、240 mg/24 mL 单剂量瓶" }, "labelSource": { "id": "src_ff06f39a33bac3c6", "label": "DailyMed（NLM）：OPDIVO 纳武利尤单抗当前美国公开标签（Bristol Myers Squibb；2026-05 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=f570b9c4-6846-4de2-abfa-4d0a4ae4e394", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "productRoutes": [ { "source": { "id": "src_ff06f39a33bac3c6", "label": "DailyMed（NLM）：OPDIVO 纳武利尤单抗当前美国公开标签（Bristol Myers Squibb；2026-05 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=f570b9c4-6846-4de2-abfa-4d0a4ae4e394", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_7a8d917cc8b41800", "label": "FDA：OPDIVO 2026 美国标签（BLA 125554）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/125554s136lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "DailyMed 的 OPDIVO（nivolumab）当前美国公开标签列示 10 mg/mL 静脉输注用注射剂，并列出四个单剂量瓶包装。本页把商品名、通用名、浓度、总体积、NDC、包装图和来源分别对应；不把瓶身数字变成个人输注量、配制、间隔、联用、停药或购买结论。", "history": "当前美国公开标签与 2026 FDA 标签共同提供阅读入口；适应症、给药、风险、市场状态与实际供应仍须以目标市场当日文件和负责团队核对。", "sourceDocuments": [ { "id": "src_ff06f39a33bac3c6", "label": "DailyMed（NLM）：OPDIVO 纳武利尤单抗当前美国公开标签（Bristol Myers Squibb；2026-05 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=f570b9c4-6846-4de2-abfa-4d0a4ae4e394", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_7a8d917cc8b41800", "label": "FDA：OPDIVO 2026 美国标签（BLA 125554）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/125554s136lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_5ed30b676fbb9773", "label": "FDA Drugs@FDA 官方检索入口", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_lookup_entry", "documentKind": "regulatory_lookup", "market": "US", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } ], "applicationNumber": "BLA 125554", "approvalTimeline": [ { "date": "DailyMed SPL v18，2026-05 发布", "title": { "zh": "当前美国公开标签的日期记录", "en": "Dated current U.S. public-label record" }, "detail": { "zh": "本页链接 DailyMed SPL v18，2026-05 发布 的当前美国公开标签，作为放大阅读和逐项核对入口。它不替代目标市场当日的批准、供应、适应症、规格或个体化用药判断。", "en": "This page links the current U.S. public label dated DailyMed SPL v18，2026-05 发布 as an enlarged-reading and item-by-item checking entry point. It does not replace same-day verification of approval, supply, indication, strength or individual use in the target market." }, "source": { "id": "src_ff06f39a33bac3c6", "label": "DailyMed: current OPDIVO U.S. public label", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=f570b9c4-6846-4de2-abfa-4d0a4ae4e394", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "已链接当前公开标签", "en": "Current public label linked" }, "detail": { "zh": "仅对应本页所列的美国公开标签；不据此推定库存、可售资格或其他市场状态。", "en": "Only the U.S. public label listed on this page is linked; no stock, sale-eligibility or other-market conclusion is inferred." } }, { "market": { "zh": "中国大陆、欧盟、日本", "en": "Mainland China, EU, Japan" }, "status": { "zh": "待逐项建立市场记录", "en": "Market record not established" }, "detail": { "zh": "不从美国公开标签推定当地批准、持有人、规格、供应或可售资格。", "en": "No local approval, holder, strength, supply or sale-eligibility conclusion is inferred from the U.S. public label." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "当前美国标签能代表其他国家或地区吗？", "en": "Does a current U.S. label represent another country or region?" }, "answer": { "zh": "不能。它是逐项阅读入口；品牌、剂型、规格、可得性和安全信息仍须以目标市场的现行官方文件核对。", "en": "No. It is an item-by-item reading entry point; brand, dosage form, strength, availability and safety information still require checking against the target market's current official document." } }, { "question": { "zh": "为什么这里不展示价格或原研/仿制结论？", "en": "Why are price and originator/generic conclusions not shown?" }, "answer": { "zh": "这些结论需要产品、剂型、规格、包装、市场、日期和原始记录分别齐全并经人工审核；单一标签文件不足以支持。", "en": "Those conclusions require separately complete and human-reviewed product, dosage-form, strength, pack, market, date and primary-record fields; one label file is insufficient." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "dosage-forms-are-part-of-medicine-identity", "medicine-label-for-everyday-questions", "how-to-read-a-drug-label" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/opdivo/", "en": "https://origindrug.com/en/drugs/opdivo/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "gleevec", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-23", "status": "published_traceable_archive" }, "names": { "brand": "Gleevec", "generic": "伊马替尼", "aliases": [ "imatinib" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "肿瘤与血液", "sourceArchiveMarket": "美国 DailyMed 公开标签（Novartis，2026-07 更新）。本页仅建立 100 mg、90 片瓶装和两款 400 mg、30 片单元剂量纸盒的精确标签面板；其他 NDC、其他包装、其他市场与后续标签须逐项另行核对。", "dosageFormClass": "伊马替尼薄膜衣口服片：100 mg、400 mg；两种每片标示量与包装呈现须分开核对", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "2001（DailyMed 2026 美国公开标签所列初始批准）", "archiveSponsorText": "Novartis Pharmaceuticals Corporation / DailyMed 公开标签" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-gleevec-imatinib-tablet-100mg-90-bottle-ndc-0078-0401-34", "marketCode": "US", "labelVersion": { "zh": "DailyMed 美国公开标签（Novartis，2026-07 更新）", "en": "DailyMed U.S. public label (Novartis, updated July 2026)" }, "dosageForm": { "zh": "伊马替尼甲磺酸盐薄膜衣口服片", "en": "imatinib mesylate film-coated oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 0078-0401-34", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片 100 mg，90 片瓶装", "en": "100 mg per tablet, 90-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=gleevec-07.jpg&setid=211ef2da-2868-4a77-8055-1cb2cd78e24b&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "伊马替尼", "en": "imatinib" }, "value": 100, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数或剂量", "en": "labelled amount per tablet; not an individual tablet count or dose" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-23", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 90, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "深黄色至棕橙色", "en": "very dark yellow to brownish orange" }, "shape": { "zh": "圆形双凸、斜边薄膜衣片", "en": "round, biconvex, bevel-edged film-coated tablet" }, "imprint": "NVR / SA", "scoreStatus": "scored_status_not_a_split_instruction", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_4145d3b98ed1029d", "label": "DailyMed（NLM）：GLEEVEC 100 mg、90 片瓶装（NDC 0078-0401-34；Novartis，2026-07）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=211ef2da-2868-4a77-8055-1cb2cd78e24b", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-gleevec-imatinib-tablet-400mg-30-unit-dose-carton-ndc-0078-0649-13", "marketCode": "US", "labelVersion": { "zh": "DailyMed 美国公开标签（Novartis，2026-07 更新）", "en": "DailyMed U.S. public label (Novartis, updated July 2026)" }, "dosageForm": { "zh": "伊马替尼甲磺酸盐薄膜衣口服片", "en": "imatinib mesylate film-coated oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 0078-0649-13", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片 400 mg，30 片单元剂量纸盒（3 板 × 10 片）", "en": "400 mg per tablet, 30-tablet unit-dose carton (3 blisters × 10)" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=gleevec-08.jpg&setid=211ef2da-2868-4a77-8055-1cb2cd78e24b&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "伊马替尼", "en": "imatinib" }, "value": 400, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数或剂量", "en": "labelled amount per tablet; not an individual tablet count or dose" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-23", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 30, "unit": { "zh": "片/单元剂量纸盒", "en": "tablets per unit-dose carton" } }, "physicalClues": { "color": { "zh": "深黄色至棕橙色", "en": "very dark yellow to brownish orange" }, "shape": { "zh": "椭圆形双凸、斜边薄膜衣片", "en": "ovaloid, biconvex, bevel-edged film-coated tablet" }, "imprint": "GLEEVEC / score", "scoreStatus": "scored_status_not_a_split_instruction", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_4145d3b98ed1029d", "label": "DailyMed（NLM）：GLEEVEC 400 mg、30 片单元剂量纸盒（NDC 0078-0649-13；Novartis，2026-07）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=211ef2da-2868-4a77-8055-1cb2cd78e24b", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-gleevec-imatinib-tablet-400mg-30-unit-dose-carton-ndc-0078-1490-13", "marketCode": "US", "labelVersion": { "zh": "DailyMed 美国公开标签（Novartis，2026-07 更新）", "en": "DailyMed U.S. public label (Novartis, updated July 2026)" }, "dosageForm": { "zh": "伊马替尼甲磺酸盐薄膜衣口服片", "en": "imatinib mesylate film-coated oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 0078-1490-13", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片 400 mg，30 片单元剂量纸盒（3 板 × 10 片）", "en": "400 mg per tablet, 30-tablet unit-dose carton (3 blisters × 10)" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=gleevec-09.jpg&setid=211ef2da-2868-4a77-8055-1cb2cd78e24b&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "伊马替尼", "en": "imatinib" }, "value": 400, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数或剂量", "en": "labelled amount per tablet; not an individual tablet count or dose" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-23", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 30, "unit": { "zh": "片/单元剂量纸盒", "en": "tablets per unit-dose carton" } }, "physicalClues": { "color": { "zh": "深黄色至棕橙色", "en": "very dark yellow to brownish orange" }, "shape": { "zh": "椭圆形双凸、斜边薄膜衣片", "en": "ovaloid, biconvex, bevel-edged film-coated tablet" }, "imprint": "400 / score with SL", "scoreStatus": "scored_status_not_a_split_instruction", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_4145d3b98ed1029d", "label": "DailyMed（NLM）：GLEEVEC 400 mg、30 片单元剂量纸盒（NDC 0078-1490-13；Novartis，2026-07）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=211ef2da-2868-4a77-8055-1cb2cd78e24b", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": null, "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=gleevec-07.jpg&setid=211ef2da-2868-4a77-8055-1cb2cd78e24b&type=img", "alt": "GLEEVEC 伊马替尼在美国 DailyMed Novartis 公开标签中的 100 mg、90 片装纸盒展开图", "archiveMarket": "美国", "labelVersion": "DailyMed 公开标签（Novartis，2026-07 更新）", "presentation": "GLEEVEC 薄膜衣片：每片伊马替尼 100 mg、90 片装纸盒展开图（DailyMed Novartis 公开标签所列）。", "notice": "此为美国 DailyMed Novartis 公开标签中明确对应 GLEEVEC、伊马替尼 100 mg、90 片装的纸盒展开图，只帮助核对品牌、通用名、片剂、标示强度、包装数量和来源；不用于鉴定真伪，也不证明 400 mg 或其他规格、其他市场标签、当前可得性、原研身份、目标市场批准或可售资格。", "source": { "id": "src_4145d3b98ed1029d", "label": "DailyMed（NLM）：GLEEVEC 公开标签（Novartis，2026-07 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=211ef2da-2868-4a77-8055-1cb2cd78e24b", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "GLEEVEC 说明书放大阅读：100 mg、400 mg 与吞咽困难时的处理都必须对应这一款标签", "en": "GLEEVEC label reading: 100 mg, 400 mg and swallowing questions must match this exact product label" }, "summary": { "zh": "本模块以 Novartis 的美国 DailyMed 2026-07 GLEEVEC 公开标签为阅读入口，帮助核对 GLEEVEC、伊马替尼、100 mg 或 400 mg 薄膜衣片、包装和目标市场；它不把标签中的数字或处理步骤变成个人剂量、停药、换药或联用方案。", "en": "This module uses Novartis' July 2026 U.S. DailyMed public label for GLEEVEC as a reading entry point. It helps check GLEEVEC, imatinib, 100 mg or 400 mg film-coated tablets, package and target market; it does not turn label numbers or handling steps into an individual dose, stopping, switching or combination plan." }, "checks": [ { "zh": "这份公开标签列出 100 mg 与 400 mg 薄膜衣片，且两种片剂均有刻痕。mg 是每片标示强度，刻痕是这份准确标签中的制剂信息；它们都不是自行掰开、拼凑、加减、按他人方案换算或替代另一种伊马替尼产品的许可。", "en": "This public label lists 100 mg and 400 mg film-coated tablets, both scored. mg identifies the stated strength per tablet, and the score is formulation information in this exact label; neither permits self-splitting, combining, adjusting, converting from another person's regimen or substituting another imatinib product." }, { "zh": "该标签为无法吞服薄膜衣片的情形列出这一个准确片剂在水或苹果汁中分散、完成分散后立即使用的特定程序。它不等于把所有肿瘤片剂都能压碎、久置、与食物混合或套用相同做法；实际药盒应由血液/肿瘤团队或药师按目标市场现行标签核对。", "en": "For inability to swallow film-coated tablets, the label gives a specific procedure for dispersing this exact tablet in water or apple juice and using it immediately after disintegration. It does not mean all oncology tablets may be crushed, stored, mixed with food or handled the same way; the actual pack needs review against the current target-market label by the haematology/oncology team or pharmacist." }, { "zh": "标签提示 CYP3A 诱导剂/抑制剂、其他经 CYP3A4 或 CYP2D6 代谢的药物、抗凝治疗和高剂量甲氨蝶呤等联用问题。抗感染药、抗凝药、甲状腺药、草本、补充剂和全部处方/非处方产品应连同实际包装交由团队核对；网页不能决定个人能否同服、如何错开或怎样调整。", "en": "The label flags CYP3A inducers/inhibitors, other medicines metabolised through CYP3A4 or CYP2D6, anticoagulation and high-dose methotrexate as co-medication issues. Anti-infectives, anticoagulants, thyroid medicine, herbs, supplements and every prescription/OTC product should be reviewed with the actual packages; a webpage cannot decide individual co-use, spacing or adjustment." }, { "zh": "出现快速体重增加或明显水肿、出血、发热、黄疸样变化、严重腹痛、呼吸或胸部不适、明显虚弱或其他急性问题时，应及时联系治疗团队或使用当地紧急医疗支持。不要仅凭网页、包装图、一次化验或另一位患者经验自行暂停、恢复或改用其他靶向药。", "en": "With rapid weight gain or marked swelling, bleeding, fever, jaundice-like changes, severe abdominal pain, breathing or chest symptoms, marked weakness or another acute concern, contact the treatment team promptly or use local urgent medical support. Do not self-pause, restart or change to another targeted medicine from a webpage, package image, one test result or another patient's experience." } ], "source": { "id": "src_4145d3b98ed1029d", "label": "DailyMed（NLM）：GLEEVEC 公开标签（Novartis，2026-07 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=211ef2da-2868-4a77-8055-1cb2cd78e24b", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "伊马替尼怎样起作用：标签描述其抑制 BCR-ABL、c-KIT 与 PDGFR 等酪氨酸激酶", "en": "How imatinib works: the label describes inhibition of BCR-ABL, c-KIT and PDGFR tyrosine kinases" }, "summary": { "zh": "FDA 的 GLEEVEC 标签描述伊马替尼抑制 BCR-ABL 酪氨酸激酶，并可抑制 c-KIT 与 PDGFR 等相关酪氨酸激酶。这解释部分分子靶点路径，不判断个人基因/分子检测是否符合、疾病是否适用、相互作用、剂量或换药。", "en": "The FDA GLEEVEC label describes imatinib as inhibiting BCR-ABL and related tyrosine kinases including c-KIT and PDGFR. This explains some molecular-target pathways, not whether individual genetic/molecular testing fits, disease suitability, interactions, dose or switching." }, "checks": [ { "zh": "“BCR-ABL”“KIT”或“靶向药”不是自己根据检测报告或相似病名选择 GLEEVEC 的依据。检测平台、融合/变异结果、疾病阶段、既往治疗、器官功能与现行标签须由血液/肿瘤专科团队综合解读。", "en": "“BCR-ABL,” “KIT” or “targeted medicine” is not a basis for selecting GLEEVEC from a test report or similar disease name. Test platform, fusion/variant result, disease setting, prior therapy, organ function and current label need haematology/oncology-team interpretation." }, { "zh": "共同抑制某种激酶不使不同靶向药、不同强度片剂或不同市场产品可自行换算、叠加、隔日轮换或替代。", "en": "Inhibiting a related kinase does not make different targeted medicines, tablet strengths or market products self-convertible, combinable, alternate-day options or substitutes." }, { "zh": "出现明显水肿、出血、发热、黄疸、严重乏力或其他急性不适时，应及时使用当地治疗团队或紧急医疗支持。", "en": "With marked oedema, bleeding, fever, jaundice, severe weakness or another acute concern, use the local treatment team or urgent medical support promptly." } ], "source": { "id": "src_bc154cbf8d8e616b", "label": "FDA：GLEEVEC 2017 美国标签（临床药理）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021588s052lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "Gleevec", "generic": "伊马替尼", "dosageFormClass": "伊马替尼薄膜衣口服片：100 mg、400 mg；两种每片标示量与包装呈现须分开核对" }, "labelSource": { "id": "src_4145d3b98ed1029d", "label": "DailyMed（NLM）：GLEEVEC 公开标签（Novartis，2026-07 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=211ef2da-2868-4a77-8055-1cb2cd78e24b", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "productRoutes": [ { "source": { "id": "src_4145d3b98ed1029d", "label": "DailyMed（NLM）：GLEEVEC 公开标签（Novartis，2026-07 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=211ef2da-2868-4a77-8055-1cb2cd78e24b", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-23", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_bc154cbf8d8e616b", "label": "FDA：GLEEVEC 2017 美国标签（NDA 021588）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021588s052lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-23", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "美国 DailyMed 的 GLEEVEC（imatinib mesylate）公开标签由 Novartis Pharmaceuticals Corporation 列示 100 mg 与 400 mg 薄膜衣口服片。本页将已核对的 100 mg、NDC 0078-0401-34、90 片瓶装，以及两款 400 mg、30 片单元剂量纸盒分别列出，方便先核对品牌、通用名、每片标示量、NDC、容器与来源；不把包装数字变成个人片数、掰开、停用、联用、转换或购买结论。", "history": "本页的三个包装面板仅对应美国 DailyMed 公开标签：100 mg、NDC 0078-0401-34、90 片瓶装；400 mg、NDC 0078-0649-13、30 片单元剂量纸盒；以及 400 mg、NDC 0078-1490-13、30 片单元剂量纸盒。100 mg 与 400 mg 的刻痕仅为所引标签中的制剂外观线索，不能成为自行掰开、拼凑、加减、换药或将其他伊马替尼产品视作相同的许可。", "sourceDocuments": [ { "id": "src_4145d3b98ed1029d", "label": "DailyMed（NLM）：GLEEVEC 公开标签（Novartis，2026-07 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=211ef2da-2868-4a77-8055-1cb2cd78e24b", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, { "id": "src_bc154cbf8d8e616b", "label": "FDA：GLEEVEC 2017 美国标签（NDA 021588）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021588s052lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_5ed30b676fbb9773", "label": "FDA Drugs@FDA 官方检索入口", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_lookup_entry", "documentKind": "regulatory_lookup", "market": "US", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } ], "applicationNumber": "NDA 021588", "approvalTimeline": [ { "date": "2001", "title": { "zh": "FDA 标签所列美国初始批准年份", "en": "Initial U.S. approval year listed in the FDA label" }, "detail": { "zh": "本页链接的 FDA 标签档案列示 Initial U.S. Approval: 2001。该历史定位不等同于当前批准、可得性、持有人或其他市场状态。", "en": "The FDA label archive linked here lists Initial U.S. Approval: 2001. This historical locator is not a conclusion about current approval, availability, holder or another market." }, "source": { "id": "src_bc154cbf8d8e616b", "label": "FDA: GLEEVEC label archive", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021588s052lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, { "date": "2017", "title": { "zh": "FDA 标签档案版本", "en": "FDA label archive version" }, "detail": { "zh": "本页链接 2017 的 FDA 标签档案作为可复核阅读入口。现行标签、规格、适应症和安全信息必须另行以目标市场当前文件核对。", "en": "This page links the 2017 FDA label archive as a traceable reading entry point. Current labeling, strength, indication and safety information require separate verification against the target market’s current document." }, "source": { "id": "src_bc154cbf8d8e616b", "label": "FDA: GLEEVEC label archive", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021588s052lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "已链接公开标签档案", "en": "Public label archive linked" }, "detail": { "zh": "仅对应本页所列 FDA 文件。", "en": "Only the FDA document listed on this page is linked." } }, { "market": { "zh": "中国大陆、欧盟、日本", "en": "Mainland China, EU, Japan" }, "status": { "zh": "待逐项建立市场记录", "en": "Market record not established" }, "detail": { "zh": "不从美国标签档案推定当地批准、持有人、规格、供应或可售资格。", "en": "No local approval, holder, strength, supply or sale-eligibility conclusion is inferred from the U.S. label archive." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "标签档案能代表现在的产品信息吗？", "en": "Does a label archive represent current product information?" }, "answer": { "zh": "不能自动代表。档案用于定位来源；需要以目标市场的现行官方标签逐项复核。", "en": "Not automatically. The archive locates a source; each point needs verification against the target market’s current official label." } }, { "question": { "zh": "为什么这里不展示价格或原研/仿制结论？", "en": "Why are price and originator/generic conclusions not shown?" }, "answer": { "zh": "这些结论需要产品、剂型、规格、包装、市场、日期和原始记录分别齐全并经人工审核；单一标签文件不足以支持。", "en": "Those conclusions require separately complete and human-reviewed product, dosage-form, strength, pack, market, date and primary-record fields; one label file is insufficient." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "how-to-read-a-drug-label", "regulatory-sources-first" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/gleevec/", "en": "https://origindrug.com/en/drugs/gleevec/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "tarceva", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-23", "status": "published_traceable_archive" }, "names": { "brand": "Tarceva", "generic": "厄洛替尼", "aliases": [ "erlotinib" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "肿瘤与血液", "sourceArchiveMarket": "美国 DailyMed 历史归档标签（Genentech，2016）。本页只建立 25 mg、100 mg、150 mg 各一款 30 片瓶装历史标签面板；它们不是当前在售、当前批准或当前 NDC 名录的证明。", "dosageFormClass": "厄洛替尼薄膜衣口服片：25 mg、100 mg、150 mg（2016 历史标签中的每片标示量）", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "2004（美国 DailyMed 2016 归档标签所列初始批准）", "archiveSponsorText": "Genentech / DailyMed 历史美国公开标签" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-tarceva-erlotinib-tablet-25mg-30-bottle-ndc-50242-062-01", "marketCode": "US", "labelVersion": { "zh": "DailyMed 美国历史归档标签（Genentech，2016）", "en": "DailyMed U.S. historical archived label (Genentech, 2016)" }, "dosageForm": { "zh": "厄洛替尼薄膜衣口服片", "en": "erlotinib film-coated oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 50242-062-01", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片 25 mg，30 片瓶装（历史标签）", "en": "25 mg per tablet, 30-tablet bottle (historical label)" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=image-07.jpg&archiveid=929318", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "厄洛替尼", "en": "erlotinib" }, "value": 25, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片历史标签标示量；不是个人片数或剂量", "en": "historical labelled amount per tablet; not an individual tablet count or dose" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-23", "currentLabelDisplayed": false, "ndcDirectoryListed": false, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 30, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "白色", "en": "white" }, "shape": { "zh": "圆形双凸、直边薄膜衣片", "en": "round, biconvex film-coated tablet with straight sides" }, "imprint": "T 25 / blank", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_0ccb14ea617765be", "label": "DailyMed（NLM）归档：TARCEVA 25 mg、30 片瓶装（NDC 50242-062-01；Genentech，2016 历史标签）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=57bccb29-1c47-4c64-ab6a-77960a91cc20", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-tarceva-erlotinib-tablet-100mg-30-bottle-ndc-50242-063-01", "marketCode": "US", "labelVersion": { "zh": "DailyMed 美国历史归档标签（Genentech，2016）", "en": "DailyMed U.S. historical archived label (Genentech, 2016)" }, "dosageForm": { "zh": "厄洛替尼薄膜衣口服片", "en": "erlotinib film-coated oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 50242-063-01", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片 100 mg，30 片瓶装（历史标签）", "en": "100 mg per tablet, 30-tablet bottle (historical label)" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=image-08.jpg&archiveid=929318", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "厄洛替尼", "en": "erlotinib" }, "value": 100, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片历史标签标示量；不是个人片数或剂量", "en": "historical labelled amount per tablet; not an individual tablet count or dose" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-23", "currentLabelDisplayed": false, "ndcDirectoryListed": false, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 30, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "白色", "en": "white" }, "shape": { "zh": "圆形双凸、直边薄膜衣片", "en": "round, biconvex film-coated tablet with straight sides" }, "imprint": "T 100 / blank", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_0ccb14ea617765be", "label": "DailyMed（NLM）归档：TARCEVA 100 mg、30 片瓶装（NDC 50242-063-01；Genentech，2016 历史标签）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=57bccb29-1c47-4c64-ab6a-77960a91cc20", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-tarceva-erlotinib-tablet-150mg-30-bottle-ndc-50242-064-01", "marketCode": "US", "labelVersion": { "zh": "DailyMed 美国历史归档标签（Genentech，2016）", "en": "DailyMed U.S. historical archived label (Genentech, 2016)" }, "dosageForm": { "zh": "厄洛替尼薄膜衣口服片", "en": "erlotinib film-coated oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 50242-064-01", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片 150 mg，30 片瓶装（历史标签）", "en": "150 mg per tablet, 30-tablet bottle (historical label)" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=image-09.jpg&archiveid=929318", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "厄洛替尼", "en": "erlotinib" }, "value": 150, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片历史标签标示量；不是个人片数或剂量", "en": "historical labelled amount per tablet; not an individual tablet count or dose" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-23", "currentLabelDisplayed": false, "ndcDirectoryListed": false, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 30, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "白色", "en": "white" }, "shape": { "zh": "圆形双凸、直边薄膜衣片", "en": "round, biconvex film-coated tablet with straight sides" }, "imprint": "T 150 / blank", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_0ccb14ea617765be", "label": "DailyMed（NLM）归档：TARCEVA 150 mg、30 片瓶装（NDC 50242-064-01；Genentech，2016 历史标签）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=57bccb29-1c47-4c64-ab6a-77960a91cc20", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-tarceva-erlotinib-tablet-150mg-30-bottle-ndc-50242-064-01", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=image-09.jpg&archiveid=929318", "alt": "TARCEVA 厄洛替尼在美国 DailyMed Genentech 归档标签中的 150 mg、30 片装纸盒展示面", "archiveMarket": "美国", "labelVersion": "DailyMed 归档公开标签（Genentech，2016 标签）", "presentation": "TARCEVA 片剂：每片厄洛替尼 150 mg、30 片装纸盒展示面（DailyMed Genentech 归档标签所列）。", "notice": "此为美国 DailyMed 所存 Genentech TARCEVA 归档标签中明确对应厄洛替尼 150 mg、30 片装的纸盒展示面，只帮助核对品牌、通用名、片剂、标示强度、包装数量和来源；不用于鉴定真伪，也不证明该历史标签所涉产品目前仍在任何市场可得，亦不证明其他规格、其他市场标签、原研身份、目标市场批准或可售资格。", "source": { "id": "src_0ccb14ea617765be", "label": "DailyMed（NLM）归档：TARCEVA 公开标签（Genentech，2016 历史标签）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=57bccb29-1c47-4c64-ab6a-77960a91cc20", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "TARCEVA 说明书放大阅读：25、100、150 mg 和胃药、吸烟问题都要回到这份准确标签", "en": "TARCEVA label reading: 25, 100 and 150 mg, stomach medicines and smoking questions must return to this exact label" }, "summary": { "zh": "本模块以 Genentech 的美国 DailyMed 2016 TARCEVA 归档公开标签为阅读入口，帮助核对 TARCEVA、厄洛替尼、25/100/150 mg 口服片、包装和该历史美国文件；它不把任何 mg、空腹条件、联用提示或历史标签文字变成个人剂量、停药、换药或联用方案。", "en": "This module uses Genentech's 2016 U.S. DailyMed archived public label for TARCEVA as a reading entry point. It helps check TARCEVA, erlotinib, 25/100/150 mg oral tablets, package and this historical U.S. document; it does not turn any mg marking, fasting condition, co-medication note or historical-label wording into an individual dose, stopping, switching or combination plan." }, "checks": [ { "zh": "该归档标签列出 25、100、150 mg 口服片；圆形、白色、双凸与相应的“T 25”“T 100”“T 150”印字，是这一美国历史标签的识别线索。强度、外观、包装、品牌和市场必须一起核对；任何一项不同都不能据此认定为同一产品、判断真伪或推定其他市场包装。", "en": "The archived label lists 25, 100 and 150 mg oral tablets; round, white, biconvex tablets with the respective “T 25,” “T 100” and “T 150” markings are identity clues in this U.S. historical label. Check strength, appearance, package, brand and market together. A difference in any one of them does not establish the same product, authenticity or packaging in another market." }, { "zh": "标签为这一个准确产品写有与进食有关的条件，并提示影响胃酸的药物、CYP3A4/CYP1A2 相关产品、吸烟和华法林等问题。胃药、抗感染药、草本、戒烟前后情况、抗凝药和全部处方/非处方产品应和实际包装一起交由肿瘤团队或药师核对；网页不能决定个人能否同服、怎样错开或怎样调整。", "en": "The label gives a meal-related condition for this exact product and flags medicines affecting gastric acidity, CYP3A4/CYP1A2-related products, smoking and warfarin. Stomach medicines, anti-infectives, herbs, changes in smoking, anticoagulants and every prescription/OTC product should be reviewed with the actual packages by the oncology team or pharmacist; a webpage cannot decide individual co-use, spacing or adjustment." }, { "zh": "同为 EGFR 靶向药、都写相同 mg，或都以口服片出现，不代表可以自行叠加、隔日轮换、由吉非替尼/其他靶向药换算、或因不适直接换一盒。肿瘤类型、分子检测、既往方案、器官功能与目标市场的现行标签需由团队综合核对。", "en": "Being an EGFR medicine, sharing an mg number or being an oral tablet does not permit self-combination, alternate-day use, conversion from gefitinib/another targeted medicine or a direct pack-to-pack change because of symptoms. Tumour type, molecular testing, prior regimen, organ function and the current target-market label need integrated team review." }, { "zh": "出现新的或加重的呼吸困难、咳嗽或发热，持续或严重腹泻、严重皮疹/水疱、眼痛或视力变化、黄疸样变化、明显出血或其他急性问题时，应及时联系治疗团队或使用当地紧急医疗支持。不要依据网页自行暂停、恢复或改用其他 EGFR 药物。", "en": "With new or worsening breathing difficulty, cough or fever, persistent or severe diarrhoea, severe rash/blistering, eye pain or vision change, jaundice-like changes, marked bleeding or another acute concern, contact the treatment team promptly or use local urgent medical support. Do not self-pause, restart or change to another EGFR medicine from a webpage." } ], "source": { "id": "src_0ccb14ea617765be", "label": "DailyMed（NLM）归档：TARCEVA 公开标签（Genentech，2016 历史标签）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=57bccb29-1c47-4c64-ab6a-77960a91cc20", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "厄洛替尼怎样起作用：标签描述其抑制 EGFR 的酪氨酸激酶活性", "en": "How erlotinib works: the label describes inhibition of EGFR tyrosine-kinase activity" }, "summary": { "zh": "FDA 的 TARCEVA 标签描述厄洛替尼为 EGFR/HER1 酪氨酸激酶的小分子抑制剂，可抑制与 EGFR 相关的细胞内磷酸化过程。它是分子机制概述，不判断个人 EGFR 检测结果、肿瘤适用性、剂量或与其他靶向药的联用。", "en": "The FDA TARCEVA label describes erlotinib as a small-molecule inhibitor of EGFR/HER1 tyrosine kinase that inhibits EGFR-related intracellular phosphorylation. It is a molecular-mechanism overview, not an interpretation of an individual's EGFR result, suitability, dose or combination." }, "checks": [ { "zh": "“EGFR”不等于看到同名检测或相似术语就能判断某个人适合 TARCEVA。准确检测方法、肿瘤类型、分子结果、既往治疗和所在市场现行标签必须交由肿瘤团队确认。", "en": "“EGFR” does not mean a same-named test or similar term can determine whether an individual fits TARCEVA. Exact test method, tumour type, molecular result, prior therapy and current target-market label require oncology-team confirmation." }, { "zh": "同为 EGFR 靶向药、都以口服片剂出现或都是同一毫克数字，不表示可自行叠加、转换、隔日轮换或替代。", "en": "Being an EGFR medicine, oral tablet or sharing a milligram number does not mean products can be self-combined, converted, alternated or substituted." }, { "zh": "出现进行性呼吸困难、严重皮疹、持续腹泻、黄疸、眼部疼痛/视力变化或其他急性问题时，应及时联系治疗团队或紧急医疗支持。", "en": "With progressive breathing trouble, severe rash, persistent diarrhoea, jaundice, eye pain/vision change or another acute concern, contact the treatment team or urgent medical support promptly." } ], "source": { "id": "src_57e793f72bfecc8b", "label": "FDA：TARCEVA 2016 美国标签（临床药理）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021743s025lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "Tarceva", "generic": "厄洛替尼", "dosageFormClass": "厄洛替尼薄膜衣口服片：25 mg、100 mg、150 mg（2016 历史标签中的每片标示量）" }, "labelSource": { "id": "src_0ccb14ea617765be", "label": "DailyMed（NLM）归档：TARCEVA 公开标签（Genentech，2016 历史标签）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=57bccb29-1c47-4c64-ab6a-77960a91cc20", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "productRoutes": [ { "source": { "id": "src_0ccb14ea617765be", "label": "DailyMed（NLM）归档：TARCEVA 公开标签（Genentech，2016 历史标签）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=57bccb29-1c47-4c64-ab6a-77960a91cc20", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-23", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_57e793f72bfecc8b", "label": "FDA：TARCEVA 2016 美国标签（NDA 021743；历史文件）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021743s025lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-23", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "美国 DailyMed 所存 Genentech 2016 TARCEVA（erlotinib）归档标签列有 25 mg、100 mg、150 mg 薄膜衣口服片。此处将三种历史 30 片瓶装的品牌、通用名、每片标示量、NDC、外观文字与原始标签分开列示，帮助核对旧药盒与阅读文件；不把 mg 或包装数量变成个人片数、停用、换药、联用或购买结论。", "history": "本页三张面板只对应历史美国标签的 TARCEVA：25 mg、NDC 50242-062-01、30 片瓶装；100 mg、NDC 50242-063-01、30 片瓶装；150 mg、NDC 50242-064-01、30 片瓶装。它们都标明为历史归档记录：不能证明今天任何地点的库存、批准、可售资格或实际药盒身份。任何现行市场状态、规格、风险或替代问题均应按目标市场现行文件逐项核验。", "sourceDocuments": [ { "id": "src_0ccb14ea617765be", "label": "DailyMed（NLM）归档：TARCEVA 公开标签（Genentech，2016 历史标签）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=57bccb29-1c47-4c64-ab6a-77960a91cc20", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, { "id": "src_57e793f72bfecc8b", "label": "FDA：TARCEVA 2016 美国标签（NDA 021743；历史文件）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021743s025lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_5ed30b676fbb9773", "label": "FDA Drugs@FDA 官方检索入口", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_lookup_entry", "documentKind": "regulatory_lookup", "market": "US", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } ], "applicationNumber": "NDA 021743", "approvalTimeline": [ { "date": "2004", "title": { "zh": "FDA 标签所列美国初始批准年份", "en": "Initial U.S. approval year listed in the FDA label" }, "detail": { "zh": "本页链接的 FDA 标签档案列示 Initial U.S. Approval: 2004。该历史定位不等同于当前批准、可得性、持有人或其他市场状态。", "en": "The FDA label archive linked here lists Initial U.S. Approval: 2004. This historical locator is not a conclusion about current approval, availability, holder or another market." }, "source": { "id": "src_57e793f72bfecc8b", "label": "FDA: TARCEVA label archive", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021743s025lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, { "date": "2016", "title": { "zh": "FDA 标签档案版本", "en": "FDA label archive version" }, "detail": { "zh": "本页链接 2016 的 FDA 标签档案作为可复核阅读入口。现行标签、规格、适应症和安全信息必须另行以目标市场当前文件核对。", "en": "This page links the 2016 FDA label archive as a traceable reading entry point. Current labeling, strength, indication and safety information require separate verification against the target market’s current document." }, "source": { "id": "src_57e793f72bfecc8b", "label": "FDA: TARCEVA label archive", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021743s025lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "已链接公开标签档案", "en": "Public label archive linked" }, "detail": { "zh": "仅对应本页所列 FDA 文件。", "en": "Only the FDA document listed on this page is linked." } }, { "market": { "zh": "中国大陆、欧盟、日本", "en": "Mainland China, EU, Japan" }, "status": { "zh": "待逐项建立市场记录", "en": "Market record not established" }, "detail": { "zh": "不从美国标签档案推定当地批准、持有人、规格、供应或可售资格。", "en": "No local approval, holder, strength, supply or sale-eligibility conclusion is inferred from the U.S. label archive." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "标签档案能代表现在的产品信息吗？", "en": "Does a label archive represent current product information?" }, "answer": { "zh": "不能自动代表。档案用于定位来源；需要以目标市场的现行官方标签逐项复核。", "en": "Not automatically. The archive locates a source; each point needs verification against the target market’s current official label." } }, { "question": { "zh": "为什么这里不展示价格或原研/仿制结论？", "en": "Why are price and originator/generic conclusions not shown?" }, "answer": { "zh": "这些结论需要产品、剂型、规格、包装、市场、日期和原始记录分别齐全并经人工审核；单一标签文件不足以支持。", "en": "Those conclusions require separately complete and human-reviewed product, dosage-form, strength, pack, market, date and primary-record fields; one label file is insufficient." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "how-to-read-a-drug-label", "regulatory-sources-first" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/tarceva/", "en": "https://origindrug.com/en/drugs/tarceva/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "iressa", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-23", "status": "published_traceable_archive" }, "names": { "brand": "Iressa", "generic": "吉非替尼", "aliases": [ "gefitinib" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "肿瘤与血液", "sourceArchiveMarket": "美国 DailyMed 有日期公开标签（AstraZeneca Pharmaceuticals LP，2023-02-28 更新）。本页仅建立 250 mg、NDC 0310-0482-30、30 片瓶装这一款标签面板；其他包装、其他市场和后续标签须分开核对。", "dosageFormClass": "吉非替尼 250 mg 薄膜衣口服片：本页精确展示 30 片瓶装；不把该单一美国标签扩展为其他规格或市场产品", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "2015（美国 DailyMed 公开标签所列初始批准年份）", "archiveSponsorText": "AstraZeneca Pharmaceuticals LP / DailyMed 美国公开标签" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-iressa-gefitinib-tablet-250mg-30-bottle-ndc-0310-0482-30", "marketCode": "US", "labelVersion": { "zh": "DailyMed 美国有日期公开标签（AstraZeneca，2023-02-28 更新）", "en": "DailyMed U.S. dated public label (AstraZeneca, updated 28 Feb 2023)" }, "dosageForm": { "zh": "吉非替尼薄膜衣口服片", "en": "gefitinib film-coated oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 0310-0482-30", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片 250 mg，30 片瓶装", "en": "250 mg per tablet, 30-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=IRESSA_250mg_Bottle_Label.jpg&setid=827d60e8-7e07-41b7-c28b-49ef1c4a5a41&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "吉非替尼", "en": "gefitinib" }, "value": 250, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数或剂量", "en": "labelled amount per tablet; not an individual tablet count or dose" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-23", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 30, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "棕色", "en": "brown" }, "shape": { "zh": "圆形双凸薄膜衣片", "en": "round, biconvex film-coated tablet" }, "imprint": "IRESSA 250 / plain", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_01c08435120fced9", "label": "DailyMed（NLM）：IRESSA 250 mg、30 片瓶装（NDC 0310-0482-30；AstraZeneca，2023-02-28 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=827d60e8-7e07-41b7-c28b-49ef1c4a5a41", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-iressa-gefitinib-tablet-250mg-30-bottle-ndc-0310-0482-30", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=IRESSA_250mg_Bottle_Label.jpg&setid=827d60e8-7e07-41b7-c28b-49ef1c4a5a41&type=img", "alt": "IRESSA 吉非替尼在美国 DailyMed AstraZeneca 公开标签中的 250 mg、30 片装容器标签图", "archiveMarket": "美国", "labelVersion": "DailyMed 美国有日期公开标签（AstraZeneca Pharmaceuticals LP，2023-02-28 更新）", "presentation": "IRESSA 薄膜衣片：每片吉非替尼 250 mg、30 片装容器标签图（DailyMed AstraZeneca Pharmaceuticals LP 公开标签所列）。", "notice": "此为美国 DailyMed AstraZeneca Pharmaceuticals LP 公开标签中明确对应 IRESSA、吉非替尼 250 mg、30 片装的容器标签图，只帮助核对品牌、通用名、片剂、标示强度、包装数量和来源；不用于鉴定真伪，也不证明其他规格、其他市场标签、当前可得性、原研身份、目标市场批准或可售资格。", "source": { "id": "src_01c08435120fced9", "label": "DailyMed（NLM）：IRESSA 公开标签（AstraZeneca Pharmaceuticals LP，2023-02-28 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=827d60e8-7e07-41b7-c28b-49ef1c4a5a41", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "IRESSA 说明书放大阅读：250 mg、吞咽困难与联用问题都要回到这一盒药的标签", "en": "IRESSA label reading: 250 mg, swallowing difficulty and co-medication questions must return to this exact product label" }, "summary": { "zh": "本模块以 AstraZeneca Pharmaceuticals LP 的美国 DailyMed 2023-02 IRESSA 公开标签为阅读入口，帮助核对 IRESSA、吉非替尼、250 mg 薄膜衣片、30 片装容器标签和目标市场；它不将标签中的数字或处理步骤变成个人剂量、换药或联用方案。", "en": "This module uses AstraZeneca Pharmaceuticals LP's February 2023 U.S. DailyMed public label for IRESSA as a reading entry point. It helps check IRESSA, gefitinib, 250 mg film-coated tablets, the 30-tablet container label and target market; it does not turn label numbers or handling instructions into an individual dose, switch or combination plan." }, "checks": [ { "zh": "这份公开标签只列出 250 mg 薄膜衣口服片；圆形、棕色、双凸并带有“IRESSA 250”刻字是该美国标签的识别线索。mg、外观、包装数量和商品名需要一起核对，任何一项不同都不能据此当作同一产品、判断真伪或推定其他市场的包装。", "en": "This public label lists 250 mg film-coated oral tablets; round, brown, biconvex tablets debossed “IRESSA 250” are identity clues in this U.S. label. Check mg, appearance, pack count and brand together. A difference in any one of them does not establish the same product, authenticity or packaging in another market." }, { "zh": "该标签为“无法吞服固体制剂”的情形列出这一个准确片剂在水中分散并立即使用的特定程序。它不是把片剂掰开、压碎、久置、与食物或其他液体混合的通用许可；对实际药盒，应由肿瘤团队或药师按目标市场现行标签确认处理方式。", "en": "The label gives a specific water-dispersion procedure for this exact tablet when solid dosage forms cannot be swallowed. It is not general permission to split, crush, store, or mix tablets with food or another liquid; handling of an actual pack needs confirmation against the current target-market label by the oncology team or pharmacist." }, { "zh": "标签提示会影响吉非替尼暴露的酶诱导剂/抑制剂、影响胃酸的药物及华法林相关出血监测问题。胃药、抗感染药、草本、抗凝药和全部处方/非处方产品都应和实际包装一起交由肿瘤团队或药师核对；网页不能判断个人能否同服、该如何错开或怎样调整。", "en": "The label flags enzyme inducers/inhibitors that affect gefitinib exposure, medicines affecting gastric acidity and warfarin-related bleeding monitoring. Stomach medicines, anti-infectives, herbs, anticoagulants and every prescription/OTC product should be reviewed with the actual packages by the oncology team or pharmacist; a webpage cannot decide individual co-use, spacing or adjustment." }, { "zh": "出现新的或加重的呼吸困难、咳嗽或发热，持续或严重腹泻，黄疸样变化，严重皮疹/水疱，眼痛或视力变化等情况，应及时联系治疗团队或使用当地紧急医疗支持。不要仅凭网页、一次检查结果或另一位患者的经验自行暂停、恢复或改用其他 EGFR 靶向药。", "en": "With new or worsening breathing difficulty, cough or fever, persistent or severe diarrhoea, jaundice-like changes, severe rash/blistering, eye pain or vision change, contact the treatment team promptly or use local urgent medical support. Do not self-pause, restart or change to another EGFR medicine from a webpage, one test result or another patient's experience." } ], "source": { "id": "src_01c08435120fced9", "label": "DailyMed（NLM）：IRESSA 公开标签（AstraZeneca Pharmaceuticals LP，2023-02-28 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=827d60e8-7e07-41b7-c28b-49ef1c4a5a41", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "吉非替尼怎样起作用：标签描述其抑制 EGFR 酪氨酸激酶相关信号", "en": "How gefitinib works: the label describes inhibition of EGFR tyrosine-kinase-related signalling" }, "summary": { "zh": "FDA 的 IRESSA 标签描述吉非替尼可抑制 EGFR 酪氨酸激酶的细胞内磷酸化，并影响下游信号转导。它解释分子信号路径，不判断个人检测是否符合、是否应使用、剂量或与其他 EGFR 药物的转换和联合方案。", "en": "The FDA IRESSA label describes gefitinib as inhibiting intracellular phosphorylation of EGFR tyrosine kinase and affecting downstream signalling. It explains a molecular pathway, not whether an individual's testing fits, whether use is appropriate, dose, conversion to another EGFR medicine or a combination plan." }, "checks": [ { "zh": "EGFR 相关检测、突变名称或他人用药经历不能替代自己的病理和分子报告解读。是否适用、检测条件、疾病设置、既往方案与目标市场现行标签必须由肿瘤团队逐项核对。", "en": "EGFR-related testing, a mutation name or another person's experience cannot replace interpretation of one's own pathology and molecular report. Suitability, testing criteria, disease setting, prior plan and current target-market label require oncology-team review." }, { "zh": "与厄洛替尼或其他 EGFR 靶向药有相近靶点，不代表可以自行叠加、交替、按毫克换算或因副作用从一盒直接改为另一盒。", "en": "A related target to erlotinib or another EGFR medicine does not permit self-combination, alternation, milligram conversion or a direct change from one pack to another because of an adverse effect." }, { "zh": "出现新的或加重的呼吸困难、持续腹泻、黄疸、严重皮疹、眼部疼痛/视力变化或其他急性问题时，应及时使用当地医疗支持。", "en": "With new or worsening breathing trouble, persistent diarrhoea, jaundice, severe rash, eye pain/vision change or another acute concern, use local medical support promptly." } ], "source": { "id": "src_ab29dccc68409008", "label": "FDA：IRESSA 2021 美国标签（临床药理）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/206995s004lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "Iressa", "generic": "吉非替尼", "dosageFormClass": "吉非替尼 250 mg 薄膜衣口服片：本页精确展示 30 片瓶装；不把该单一美国标签扩展为其他规格或市场产品" }, "labelSource": { "id": "src_01c08435120fced9", "label": "DailyMed（NLM）：IRESSA 公开标签（AstraZeneca Pharmaceuticals LP，2023-02-28 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=827d60e8-7e07-41b7-c28b-49ef1c4a5a41", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "productRoutes": [ { "source": { "id": "src_01c08435120fced9", "label": "DailyMed（NLM）：IRESSA 公开标签（AstraZeneca Pharmaceuticals LP，2023-02-28 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=827d60e8-7e07-41b7-c28b-49ef1c4a5a41", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-23", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_ab29dccc68409008", "label": "FDA：IRESSA 2021 美国标签（NDA 206995；历史文件）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/206995s004lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-23", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "美国 DailyMed 的 IRESSA（gefitinib）公开标签列有 250 mg 薄膜衣口服片、NDC 0310-0482-30 与 30 片瓶装面板。本页将品牌、通用名、每片标示量、NDC、外观线索和一手标签放在一起，帮助先核对药盒；不把 250 mg 或 30 片包装变成个人片数、吞服处理、停用、换药、联用或购买结论。", "history": "本页只对应美国 DailyMed 2023-02-28 更新的 IRESSA 250 mg、NDC 0310-0482-30、30 片瓶装。页面的 NDC 信息列营销开始日期且未列营销截止日期，但这不能证明今天任何地点的库存、可售资格、个体适用性，亦不能让读者把相近 EGFR 药物、其他市场产品或未来标签版本视作相同产品。", "sourceDocuments": [ { "id": "src_01c08435120fced9", "label": "DailyMed（NLM）：IRESSA 公开标签（AstraZeneca Pharmaceuticals LP，2023-02-28 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=827d60e8-7e07-41b7-c28b-49ef1c4a5a41", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, { "id": "src_ab29dccc68409008", "label": "FDA：IRESSA 2021 美国标签（NDA 206995；历史文件）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/206995s004lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_5ed30b676fbb9773", "label": "FDA Drugs@FDA 官方检索入口", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_lookup_entry", "documentKind": "regulatory_lookup", "market": "US", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } ], "applicationNumber": "NDA 206995", "approvalTimeline": [ { "date": "2021-05", "title": { "zh": "FDA 标签档案版本", "en": "FDA label archive version" }, "detail": { "zh": "本页链接 2021-05 的 FDA 标签档案作为可复核阅读入口。现行标签、规格、适应症和安全信息必须另行以目标市场当前文件核对。", "en": "This page links the 2021-05 FDA label archive as a traceable reading entry point. Current labeling, strength, indication and safety information require separate verification against the target market’s current document." }, "source": { "id": "src_ab29dccc68409008", "label": "FDA: IRESSA label archive", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/206995s004lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "已链接公开标签档案", "en": "Public label archive linked" }, "detail": { "zh": "仅对应本页所列 FDA 文件。", "en": "Only the FDA document listed on this page is linked." } }, { "market": { "zh": "中国大陆、欧盟、日本", "en": "Mainland China, EU, Japan" }, "status": { "zh": "待逐项建立市场记录", "en": "Market record not established" }, "detail": { "zh": "不从美国标签档案推定当地批准、持有人、规格、供应或可售资格。", "en": "No local approval, holder, strength, supply or sale-eligibility conclusion is inferred from the U.S. label archive." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "标签档案能代表现在的产品信息吗？", "en": "Does a label archive represent current product information?" }, "answer": { "zh": "不能自动代表。档案用于定位来源；需要以目标市场的现行官方标签逐项复核。", "en": "Not automatically. The archive locates a source; each point needs verification against the target market’s current official label." } }, { "question": { "zh": "为什么这里不展示价格或原研/仿制结论？", "en": "Why are price and originator/generic conclusions not shown?" }, "answer": { "zh": "这些结论需要产品、剂型、规格、包装、市场、日期和原始记录分别齐全并经人工审核；单一标签文件不足以支持。", "en": "Those conclusions require separately complete and human-reviewed product, dosage-form, strength, pack, market, date and primary-record fields; one label file is insufficient." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "how-to-read-a-drug-label", "regulatory-sources-first" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/iressa/", "en": "https://origindrug.com/en/drugs/iressa/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "tagrisso", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-22", "status": "published_traceable_archive" }, "names": { "brand": "Tagrisso", "generic": "奥希替尼", "aliases": [ "泰瑞沙", "TAGRISSO", "osimertinib", "奥希替尼", "甲磺酸奥希替尼", "osimertinib mesylate" ], "marketBrandNames": [ { "name": "泰瑞沙®", "market": { "zh": "中国大陆", "en": "Mainland China" }, "evidenceStatus": "company_product_page_name_and_strength_cue", "note": { "zh": "阿斯利康中国肿瘤产品页列示“泰瑞沙®（甲磺酸奥希替尼片）80 mg”。该企业页面仅支持核对中文商品名、通用名线索和所列强度；不确认现行批准、包装、供应、可售资格或个人使用。", "en": "AstraZeneca China's oncology product page lists 泰瑞沙® (osimertinib mesylate tablets) 80 mg. This company page supports checking the Chinese trade-name, generic-name cue and listed strength only; it does not establish current authorisation, packaging, supply, sale eligibility or individual use." }, "source": { "id": "src_dd817f06ac5828d2", "label": "阿斯利康中国：肿瘤产品页（泰瑞沙®／甲磺酸奥希替尼片 80 mg）", "url": "https://www.astrazeneca.com.cn/zh/our-focus-areas/oncology.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "first_party_product_page", "market": "CN", "accessStatus": "public_access_with_site_controls", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "mainlandChinaTradeNameCue": { "value": "泰瑞沙®", "status": "discovery_cue_requires_target_market_verification", "source": { "id": "src_dd817f06ac5828d2", "label": "阿斯利康中国：肿瘤产品页（泰瑞沙®／甲磺酸奥希替尼片 80 mg）", "url": "https://www.astrazeneca.com.cn/zh/our-focus-areas/oncology.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "first_party_product_page", "market": "CN", "accessStatus": "public_access_with_site_controls", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } }, "identity": { "therapeuticArea": "肿瘤与血液", "sourceArchiveMarket": "美国 DailyMed TAGRISSO（osimertinib）有日期公开标签，SPL v36 于 2026-04-22 发布；本档案只展示该标签中可逐一对应的 40 mg、80 mg、各 30 片瓶装面板。阿斯利康中国公开肿瘤产品页列示“泰瑞沙®（甲磺酸奥希替尼片）80 mg”，仅作为中国名称和规格检索线索，不推定现行批准、包装、供应、可得性或个人适用性。", "dosageFormClass": "口服薄膜衣片：40 mg、80 mg（DailyMed SPL v36 所列；本页分别展示两个 30 片瓶装面板）", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "2015（DailyMed 当前美国公开标签所列初始批准）", "archiveSponsorText": "AstraZeneca Pharmaceuticals LP / DailyMed 美国公开标签" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [ "AZD9291 clinical-trial supply", "osimertinib injection", "奥希替尼注射液", "oral suspension", "口服混悬液", "口服混悬" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-tagrisso-osimertinib-tablet-40mg-30bottle-ndc-0310-1349-30", "marketCode": "US", "labelVersion": { "zh": "DailyMed 美国公开标签 SPL v36（2026-04-22 发布）", "en": "U.S. DailyMed public label, SPL v36 (published 22 Apr 2026)" }, "dosageForm": { "zh": "TAGRISSO 奥希替尼口服薄膜衣片", "en": "TAGRISSO osimertinib film-coated oral tablet" }, "route": { "zh": "口服（标签产品身份字段）", "en": "oral (label product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 0310-1349-30", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片 40 mg；30 片瓶装", "en": "40 mg per tablet; 30-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=image_08.jpg&setid=5e81b4a7-b971-45e1-9c31-29cea8c87ce7&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "奥希替尼", "en": "osimertinib" }, "value": 40, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、疗程或换算", "en": "labelled amount per tablet; not an individual's tablet count, course or conversion" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-22", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 30, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "米色（标签描述）", "en": "beige (label description)" }, "shape": { "zh": "圆形、双凸片（标签描述）", "en": "round, biconvex tablet (label description)" }, "imprint": "AZ 40 / plain reverse", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_de01b0b37d6ccdaf", "label": "DailyMed（NLM）：TAGRISSO 奥希替尼美国公开标签（AstraZeneca；SPL v36，2026-04-22 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=5e81b4a7-b971-45e1-9c31-29cea8c87ce7", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-tagrisso-osimertinib-tablet-80mg-30bottle-ndc-0310-1350-30", "marketCode": "US", "labelVersion": { "zh": "DailyMed 美国公开标签 SPL v36（2026-04-22 发布）", "en": "U.S. DailyMed public label, SPL v36 (published 22 Apr 2026)" }, "dosageForm": { "zh": "TAGRISSO 奥希替尼口服薄膜衣片", "en": "TAGRISSO osimertinib film-coated oral tablet" }, "route": { "zh": "口服（标签产品身份字段）", "en": "oral (label product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 0310-1350-30", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片 80 mg；30 片瓶装", "en": "80 mg per tablet; 30-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=image_09.jpg&setid=5e81b4a7-b971-45e1-9c31-29cea8c87ce7&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "奥希替尼", "en": "osimertinib" }, "value": 80, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、疗程或换算", "en": "labelled amount per tablet; not an individual's tablet count, course or conversion" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-22", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 30, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "米色（标签描述）", "en": "beige (label description)" }, "shape": { "zh": "椭圆形、双凸片（标签描述）", "en": "oval, biconvex tablet (label description)" }, "imprint": "AZ 80 / plain reverse", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_de01b0b37d6ccdaf", "label": "DailyMed（NLM）：TAGRISSO 奥希替尼美国公开标签（AstraZeneca；SPL v36，2026-04-22 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=5e81b4a7-b971-45e1-9c31-29cea8c87ce7", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-tagrisso-osimertinib-tablet-80mg-30bottle-ndc-0310-1350-30", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=image_09.jpg&setid=5e81b4a7-b971-45e1-9c31-29cea8c87ce7&type=img", "alt": "TAGRISSO 奥希替尼在美国 DailyMed 公开标签中的 80 mg、NDC 0310-1350-30、30 片瓶装展示面", "archiveMarket": "美国", "labelVersion": "DailyMed SPL v36（2026-04-22 发布）", "presentation": "TAGRISSO 奥希替尼：每片 80 mg，NDC 0310-1350-30，30 片瓶装。", "notice": "此图只对应美国 DailyMed SPL v36 中 TAGRISSO、奥希替尼、每片 80 mg、NDC 0310-1350-30 与 30 片瓶装。它只帮助核对品牌、通用名、每片标签量、片剂、包装数量和来源；不用于鉴定真伪，也不证明 40 mg、其他 NDC、其他包装、其他市场、当前可得性、原研身份、可替代性，或任何个人的片数、疗程、联用、换药或停药方案。", "source": { "id": "src_de01b0b37d6ccdaf", "label": "DailyMed（NLM）：TAGRISSO 奥希替尼美国公开标签（AstraZeneca；SPL v36，2026-04-22 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=5e81b4a7-b971-45e1-9c31-29cea8c87ce7", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "TAGRISSO／泰瑞沙说明书放大阅读：40、80 mg 先是准确片剂身份", "en": "TAGRISSO label reading: 40 and 80 mg identify exact tablets first" }, "summary": { "zh": "本模块只阅读 DailyMed 美国公开标签中 TAGRISSO、奥希替尼、40/80 mg 口服薄膜衣片和两个 30 片包装面板。它不根据包装数字、肿瘤名称、基因词或网页信息决定任何人的片数、疗程、联用、停用、换药或是否适合治疗。", "en": "This module reads only TAGRISSO, osimertinib, 40/80 mg film-coated oral tablets and two 30-tablet package panels in the U.S. DailyMed public label. It does not use package numbers, cancer wording, genetic terms or website content to decide any person's tablet count, course, co-use, stopping, switching or treatment suitability." }, "checks": [ { "zh": "先把完整商品名、通用名、每片 40 或 80 mg、口服薄膜衣片、实际 NDC、包装和目标市场一起核对。40 mg 与 80 mg 是两个准确片剂的身份字段，不是网页可换算成个人片数、减量、补用或疗程的规则。", "en": "Check the full trade name, generic name, 40 or 80 mg per tablet, film-coated oral-tablet form, actual NDC, package and target market together. 40 mg and 80 mg identify two exact tablets; they are not a web rule for individual tablet count, reduction, make-up use or treatment course." }, { "zh": "该美国标签列出片剂可按特定标签说明分散于水中、但不应压碎。这个产品特定的标签文字并不表示另一种口服抗肿瘤药、另一市场包装或任何有吞咽困难者都可按同样方式处理；应由药师或开方团队核对实际产品和处方。", "en": "The U.S. label states that these tablets may be dispersed in water under its specific instructions but should not be crushed. This product-specific wording does not mean another oral oncology medicine, another-market pack or any swallowing difficulty can be handled the same way; have a pharmacist or prescriber review the actual product and prescription." }, { "zh": "标签中的 EGFR 突变、检测和疾病阶段文字用于界定所引美国标签的适用人群；它不等于每位肺部疾病患者都应做同一检测，也不让网页解释个人检测结果、决定治疗或自行调整药物。带原始检测报告、病理资料和完整药单请肿瘤团队解释。", "en": "EGFR-mutation, testing and disease-stage wording in the label defines the populations in that U.S. document. It does not mean every person with lung disease should have the same test, and it does not let a webpage interpret an individual's result, decide treatment or direct self-adjustment. Bring the original testing report, pathology material and full medicine list to the oncology team." }, { "zh": "标签列出间质性肺病/肺炎、QTc 间期延长、心肌病、角膜炎及皮肤反应等需及时评估的安全信息。呼吸困难、胸痛、晕厥、明显心悸、突发视力问题或其他急性严重不适应优先使用当地紧急医疗渠道；不要仅凭网页自行继续、停用、补用或改用其他抗肿瘤药。", "en": "The label includes safety information requiring timely assessment for interstitial lung disease/pneumonitis, QTc prolongation, cardiomyopathy, keratitis and skin reactions. Breathing difficulty, chest pain, fainting, marked palpitations, sudden visual problems or another acute severe concern require local urgent medical care first; do not use a webpage to continue, stop, make up or change an anticancer medicine." } ], "source": { "id": "src_de01b0b37d6ccdaf", "label": "DailyMed（NLM）：TAGRISSO 奥希替尼美国公开标签（AstraZeneca；SPL v36，2026-04-22 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=5e81b4a7-b971-45e1-9c31-29cea8c87ce7", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "奥希替尼怎样起作用：标签描述其为与特定突变 EGFR 不可逆结合的激酶抑制剂", "en": "How osimertinib works: the label describes an irreversible kinase inhibitor of certain mutant EGFR forms" }, "summary": { "zh": "美国标签将奥希替尼描述为 EGFR 激酶抑制剂，并说明其可与某些突变形式的 EGFR 不可逆结合。这个机制帮助读者理解标签中的药理语言，不预测个人疗效、风险、耐受性、剂量、联用或是否适合治疗。", "en": "The U.S. label describes osimertinib as an EGFR kinase inhibitor that binds irreversibly to certain mutant EGFR forms. This mechanism helps read the label's pharmacology; it does not predict an individual's benefit, risk, tolerance, dose, co-use or treatment suitability." }, "checks": [ { "zh": "“EGFR 激酶抑制剂”是作用路径用语，不表示任何 EGFR 检测阳性、肺癌、同类靶向药或不同市场的奥希替尼产品可以自行互换、叠加或按 mg 换算。", "en": "“EGFR kinase inhibitor” is pathway wording; it does not mean any positive EGFR test, lung cancer, related targeted medicine or another-market osimertinib product can be self-switched, combined or milligram-converted." }, { "zh": "检测名称、突变名称和药品名称都只是需要专业人员一起核对的证据片段。它们不能取代病理、影像、器官功能、既往治疗、当前说明书、完整药单或肿瘤团队的个体化判断。", "en": "Test names, mutation names and medicine names are only evidence fragments that need professional review together. They do not replace pathology, imaging, organ function, prior treatment, the current label, the complete medicine list or individual assessment by an oncology team." }, { "zh": "机制解释不能替代药物警戒或相互作用核对。出现新的呼吸、心律、视觉、皮肤或其他令人担忧的症状，或准备加入处方药、非处方药、补充剂或草本时，应让肿瘤团队和药师审阅实际产品与完整药单。", "en": "A mechanism explanation does not replace pharmacovigilance or interaction review. With new respiratory, rhythm, visual, skin or other concerning symptoms, or before adding a prescription, OTC product, supplement or herb, have the oncology team and pharmacist review the actual product and complete medicine list." } ], "source": { "id": "src_de01b0b37d6ccdaf", "label": "DailyMed（NLM）：TAGRISSO 奥希替尼美国公开标签（AstraZeneca；SPL v36，2026-04-22 发布；Clinical Pharmacology）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=5e81b4a7-b971-45e1-9c31-29cea8c87ce7", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "Tagrisso", "generic": "奥希替尼", "dosageFormClass": "口服薄膜衣片：40 mg、80 mg（DailyMed SPL v36 所列；本页分别展示两个 30 片瓶装面板）" }, "labelSource": { "id": "src_de01b0b37d6ccdaf", "label": "DailyMed（NLM）：TAGRISSO 奥希替尼美国公开标签（AstraZeneca；SPL v36，2026-04-22 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=5e81b4a7-b971-45e1-9c31-29cea8c87ce7", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" }, "productRoutes": [ { "source": { "id": "src_de01b0b37d6ccdaf", "label": "DailyMed（NLM）：TAGRISSO 奥希替尼美国公开标签（AstraZeneca；SPL v36，2026-04-22 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=5e81b4a7-b971-45e1-9c31-29cea8c87ce7", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-22", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-22", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "DailyMed 的 TAGRISSO（osimertinib）美国公开标签列出 40 mg、80 mg 口服薄膜衣片。本页把商品名、通用名、每片标示量、准确 NDC、包装外观和原始说明书入口并列，帮助读者看清“每片多少 mg”是产品身份，不把它转换成个人片数、联用、换药、停用或购买结论。", "history": "该美国公开标签列示 Initial U.S. Approval: 2015，且当前 SPL 记录为 v36、2026-04-22 发布。本页只锚定该美国文件和两个对应 30 片瓶装面板；中国页面中的“泰瑞沙®”仅用于中文名称检索，其他市场产品、不同 NDC、不同包装、其他剂型与个体化治疗均须按实际产品和所在市场现行资料另行核对。", "sourceDocuments": [ { "id": "src_de01b0b37d6ccdaf", "label": "DailyMed（NLM）：TAGRISSO 奥希替尼美国公开标签（AstraZeneca；SPL v36，2026-04-22 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=5e81b4a7-b971-45e1-9c31-29cea8c87ce7", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" }, { "id": "src_dd817f06ac5828d2", "label": "阿斯利康中国：肿瘤产品页（泰瑞沙®／甲磺酸奥希替尼片 80 mg）", "url": "https://www.astrazeneca.com.cn/zh/our-focus-areas/oncology.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "first_party_product_page", "market": "CN", "accessStatus": "public_access_with_site_controls", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } ], "applicationNumber": "NDA 208065", "approvalTimeline": [ { "date": "2015", "title": { "zh": "FDA 标签所列美国初始批准年份", "en": "Initial U.S. approval year listed in the FDA label" }, "detail": { "zh": "本页链接的 FDA 标签档案列示 Initial U.S. Approval: 2015。该历史定位不等同于当前批准、可得性、持有人或其他市场状态。", "en": "The FDA label archive linked here lists Initial U.S. Approval: 2015. This historical locator is not a conclusion about current approval, availability, holder or another market." }, "source": { "id": "src_de01b0b37d6ccdaf", "label": "DailyMed: TAGRISSO osimertinib U.S. public label, SPL v36", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=5e81b4a7-b971-45e1-9c31-29cea8c87ce7", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "date": "DailyMed SPL v36, published 2026-04-22", "title": { "zh": "FDA 标签档案版本", "en": "FDA label archive version" }, "detail": { "zh": "本页链接 DailyMed SPL v36, published 2026-04-22 的 FDA 标签档案作为可复核阅读入口。现行标签、规格、适应症和安全信息必须另行以目标市场当前文件核对。", "en": "This page links the DailyMed SPL v36, published 2026-04-22 FDA label archive as a traceable reading entry point. Current labeling, strength, indication and safety information require separate verification against the target market’s current document." }, "source": { "id": "src_de01b0b37d6ccdaf", "label": "DailyMed: TAGRISSO osimertinib U.S. public label, SPL v36", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=5e81b4a7-b971-45e1-9c31-29cea8c87ce7", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "已链接公开标签档案", "en": "Public label archive linked" }, "detail": { "zh": "仅对应本页所列 FDA 文件。", "en": "Only the FDA document listed on this page is linked." } }, { "market": { "zh": "中国大陆、欧盟、日本", "en": "Mainland China, EU, Japan" }, "status": { "zh": "待逐项建立市场记录", "en": "Market record not established" }, "detail": { "zh": "不从美国标签档案推定当地批准、持有人、规格、供应或可售资格。", "en": "No local approval, holder, strength, supply or sale-eligibility conclusion is inferred from the U.S. label archive." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "标签档案能代表现在的产品信息吗？", "en": "Does a label archive represent current product information?" }, "answer": { "zh": "不能自动代表。档案用于定位来源；需要以目标市场的现行官方标签逐项复核。", "en": "Not automatically. The archive locates a source; each point needs verification against the target market’s current official label." } }, { "question": { "zh": "为什么这里不展示价格或原研/仿制结论？", "en": "Why are price and originator/generic conclusions not shown?" }, "answer": { "zh": "这些结论需要产品、剂型、规格、包装、市场、日期和原始记录分别齐全并经人工审核；单一标签文件不足以支持。", "en": "Those conclusions require separately complete and human-reviewed product, dosage-form, strength, pack, market, date and primary-record fields; one label file is insufficient." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "how-to-read-a-drug-label", "regulatory-sources-first" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/tagrisso/", "en": "https://origindrug.com/en/drugs/tagrisso/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "arimidex", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-25", "status": "published_traceable_archive" }, "names": { "brand": "ARIMIDEX", "generic": "阿那曲唑", "aliases": [ "ARIMIDEX", "anastrozole", "阿那曲唑", "阿瑞米得" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "肿瘤与血液", "sourceArchiveMarket": "美国：DailyMed 当前 ARIMIDEX 公开标签（SPL v12，2026-03-02 生效）列示阿那曲唑 1 mg 口服片、NDC 62559-670-30 与 30 片瓶装。该文件不建立中国大陆、欧盟、日本或其他市场的商品名、批准、供应、可售资格、原研/仿制关系或可替代性。", "dosageFormClass": "阿那曲唑口服薄膜衣片：每片 1 mg（美国当前公开标签所列；30 片瓶装）", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "1995（当前美国公开标签所列 Initial U.S. Approval）", "archiveSponsorText": "ANI Pharmaceuticals, Inc.（所引美国公开标签所列标签方）" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [ "tamoxifen", "他莫昔芬", "letrozole", "来曲唑", "exemestane", "依西美坦", "anastrozole other package", "其他阿那曲唑包装" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-arimidex-anastrozole-tablet-1mg-30-bottle-ndc-62559-670-30", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（SPL v12；2026-03-02 生效；处方信息 2026-03 修订）", "en": "Current U.S. DailyMed public label (SPL v12; effective 2 Mar 2026; prescribing information revised Mar 2026)" }, "dosageForm": { "zh": "ARIMIDEX 阿那曲唑口服薄膜衣片", "en": "ARIMIDEX anastrozole film-coated oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 62559-670-30", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片阿那曲唑 1 mg；30 片瓶装", "en": "Anastrozole 1 mg per tablet; 30-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=label.jpg&id=939052", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "阿那曲唑", "en": "anastrozole" }, "value": 1, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、疗程、联用、换药或调整规则", "en": "labelled amount per tablet; not an individual's tablet count, treatment duration, co-use, switching or adjustment rule" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-25", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 30, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "白色", "en": "white" }, "shape": { "zh": "双凸圆形薄膜衣片，约 6 mm；无刻痕，不是自行掰开指示", "en": "biconvex round film-coated tablet, about 6 mm; unscored, not a self-splitting instruction" }, "imprint": "Adx / 1", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_74b020ab375fbc1f", "label": "DailyMed（NLM）：ARIMIDEX 阿那曲唑当前美国公开标签（ANI Pharmaceuticals；SPL v12，2026-03-02 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=acbfaaa9-503c-4691-9828-76a7146ed6de&version=12", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-25", "reviewedAt": "2026-08-25" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-arimidex-anastrozole-tablet-1mg-30-bottle-ndc-62559-670-30", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=label.jpg&id=939052", "alt": "ARIMIDEX 阿那曲唑 1 mg、NDC 62559-670-30、30 片瓶装在美国 DailyMed 当前公开标签中的包装图", "archiveMarket": "美国", "labelVersion": "DailyMed SPL v12（2026-03-02 生效；处方信息 2026-03 修订）", "presentation": "ARIMIDEX 阿那曲唑：每片 1 mg，NDC 62559-670-30，30 片瓶装（美国当前公开标签）。", "notice": "此图只对应美国 DailyMed 当前公开标签中的 ARIMIDEX、阿那曲唑 1 mg、NDC 62559-670-30 与 30 片瓶装。它只帮助核对品牌、通用名、每片标示量、包装、外观和来源；不用于鉴定真伪，也不代表其他阿那曲唑包装、他莫昔芬、来曲唑、依西美坦、其他内分泌治疗产品、其他市场、当前可得性、原研身份、相等性、可替代性或任何个人的片数、疗程、联用、换药或停药方案。", "source": { "id": "src_74b020ab375fbc1f", "label": "DailyMed（NLM）：ARIMIDEX 阿那曲唑 1 mg、30 片瓶装当前美国公开标签面板（ANI Pharmaceuticals；SPL v12）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=acbfaaa9-503c-4691-9828-76a7146ed6de&version=12", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-25", "reviewedAt": "2026-08-25" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "ARIMIDEX／阿那曲唑说明书放大阅读：先认清 1 mg、NDC 与 30 片瓶装", "en": "ARIMIDEX label reading: identify 1 mg, NDC and the 30-tablet bottle first" }, "summary": { "zh": "本模块只阅读美国 DailyMed 当前标签中的 ARIMIDEX、阿那曲唑、每片 1 mg、准确 NDC、30 片瓶装、外形与警示。它不提供个人片数、用药时间、疗程、同服、停用、换药、分片或购买方案。", "en": "This module reads only ARIMIDEX, anastrozole, 1 mg per tablet, the exact NDC, 30-tablet bottle, appearance and warnings in the current U.S. DailyMed label. It provides no individual tablet count, timing, treatment duration, co-use, stopping, switching, splitting or purchase plan." }, "checks": [ { "zh": "先同时核对 ARIMIDEX、阿那曲唑、1 mg、实际 NDC、30 片瓶装、白色圆片、Adx/1 压印与目标市场。mg 是这个准确片剂每片的标示量，不是网页可计算的个人片数、疗程、与其他内分泌治疗产品换算或联用规则。", "en": "Check ARIMIDEX, anastrozole, 1 mg, the actual NDC, 30-tablet bottle, white round tablet, Adx/1 imprint and target market together. mg is the labelled amount in that exact tablet, not a web calculation for tablet count, treatment duration, conversion to another endocrine therapy or co-use." }, { "zh": "当前标签所示片剂无刻痕；颜色、大小、圆形和压印只用于辅助核对，不能鉴定真伪，也不是自行掰开、减量或由一种包装替换另一种的指令。", "en": "The displayed current-label tablet is unscored. Colour, size, round shape and imprint are supporting checks only; they cannot authenticate a product and are not instructions to self-split, reduce use or replace one package with another." }, { "zh": "当前标签将缺血性心血管病、骨密度下降、胆固醇变化、肝功能异常、皮肤反应与胚胎-胎儿毒性等列为需要阅读和专业核对的内容。请把实际药盒、全部处方药、非处方药、补充剂与相关检查资料交给开方团队或药师逐项核对；网页不能把这些条目变成个人的“能否继续、联用或更换”结论。", "en": "The current label identifies ischaemic cardiovascular disease, decreased bone mineral density, cholesterol changes, liver-function abnormalities, skin reactions and embryo-fetal toxicity as items for reading and professional review. Give the actual pack, all prescription medicines, OTC products, supplements and relevant test information to the prescribing team or pharmacist for item-by-item review; this page cannot turn them into an individual continue, co-use or switching decision." }, { "zh": "出现呼吸困难、面部或喉部肿胀、明显过敏样反应、胸痛、严重或令人担心的不适时，应优先使用当地医疗支持；不要通过同时停换多种药来试探原因。", "en": "With breathing difficulty, swelling of the face or throat, a marked allergy-like reaction, chest pain, or a severe or worrying symptom, prioritise local medical support; do not test the cause by stopping or changing several medicines at once." } ], "source": { "id": "src_74b020ab375fbc1f", "label": "DailyMed（NLM）：ARIMIDEX 阿那曲唑当前美国公开标签（Warnings, Precautions and Patient Counseling；ANI Pharmaceuticals；SPL v12）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=acbfaaa9-503c-4691-9828-76a7146ed6de&version=12", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-25", "reviewedAt": "2026-08-25" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "机制阅读：标签所述芳香化酶抑制路径，不是自行选择、替代或联用规则", "en": "Mechanism reading: the label's aromatase-inhibition pathway is not a self-selection, substitution or co-use rule" }, "summary": { "zh": "当前美国标签将阿那曲唑描述为选择性、非甾体芳香化酶抑制剂，并描述其与雌二醇水平相关的药理作用。这帮助读者理解标签术语；它不能判断某人应否使用、与他莫昔芬或其他产品如何衔接、能否同服、持续多久或是否适合。", "en": "The current U.S. label describes anastrozole as a selective, nonsteroidal aromatase inhibitor and describes pharmacology related to estradiol levels. This helps readers understand label language; it cannot decide whether someone should use it, how it relates to tamoxifen or another product, whether products can be used together, duration or suitability." }, "checks": [ { "zh": "“芳香化酶抑制剂”“激素受体”或任何一个机制词，不能证明不同产品相等、可替代或可自行叠加；每个实际产品、目标市场标签和完整药单都需要单独核对。", "en": "“Aromatase inhibitor”, “hormone receptor”, or any one mechanism term does not prove that products are equal, interchangeable or suitable for self-directed combining; each actual product, target-market label and complete medicine list needs separate review." }, { "zh": "机制页不把个人诊断、病理结果、年龄、骨密度、心血管病史、肝功能、其他疾病或完整药单简化为“该不该吃、吃多久或换哪一种”的答案；已有检查或基因报告也须由专业人员结合这些资料解释。", "en": "A mechanism page does not reduce an individual's diagnosis, pathology, age, bone density, cardiovascular history, liver function, other conditions or complete medicine list to an answer about whether to use it, duration or what to change to; existing tests or genetic reports also need professional interpretation with those materials." }, { "zh": "不要把机制、包装图或 1 mg 数字用于处理急性症状、补用、停用、换药或联用。现实问题必须回到准确产品的现行目标市场标签和开方团队或药师。", "en": "Do not use mechanism, a package image or the 1 mg number to handle an acute symptom, make-up use, stopping, switching or co-use. Real questions must return to the current target-market label for the exact product and the prescribing team or pharmacist." } ], "source": { "id": "src_74b020ab375fbc1f", "label": "DailyMed（NLM）：ARIMIDEX 阿那曲唑当前美国公开标签（Clinical Pharmacology；ANI Pharmaceuticals；SPL v12）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=acbfaaa9-503c-4691-9828-76a7146ed6de&version=12", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-25", "reviewedAt": "2026-08-25" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "ARIMIDEX", "generic": "阿那曲唑", "dosageFormClass": "阿那曲唑口服薄膜衣片：每片 1 mg（美国当前公开标签所列；30 片瓶装）" }, "labelSource": { "id": "src_74b020ab375fbc1f", "label": "DailyMed（NLM）：ARIMIDEX 阿那曲唑当前美国公开标签（ANI Pharmaceuticals；SPL v12，2026-03-02 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=acbfaaa9-503c-4691-9828-76a7146ed6de&version=12", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-25", "reviewedAt": "2026-08-25" }, "productRoutes": [ { "source": { "id": "src_74b020ab375fbc1f", "label": "DailyMed（NLM）：ARIMIDEX 阿那曲唑当前美国公开标签（ANI Pharmaceuticals；SPL v12，2026-03-02 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=acbfaaa9-503c-4691-9828-76a7146ed6de&version=12", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-25", "reviewedAt": "2026-08-25" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-25", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-25", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "DailyMed 的当前 ARIMIDEX（anastrozole）美国公开标签列示 1 mg 口服薄膜衣片、NDC、30 片瓶装、白色圆片外观与 Adx/1 压印。本页帮助读者把商品名、通用名、每片标示量、准确包装、公开电子说明书和药物警戒阅读路径放在一起；不把 mg、包装数量、肿瘤诊断或“同属内分泌治疗”转换为个人片数、疗程、同服、停用、换药、替代或购买结论。", "history": "当前标签列示 Initial U.S. Approval: 1995，SPL v12 的生效日期为 2026-03-02。1 mg、NDC 62559-670-30 与 30 片瓶装共同识别所展示的准确美国产品；相近药名、同为内分泌治疗、相似白色圆片或相同 1 mg 数字，均不能建立与他莫昔芬、来曲唑、依西美坦、其他阿那曲唑包装或其他市场产品的自行互换、合用或换算关系。", "sourceDocuments": [ { "id": "src_74b020ab375fbc1f", "label": "DailyMed（NLM）：ARIMIDEX 阿那曲唑当前美国公开标签（ANI Pharmaceuticals；SPL v12，2026-03-02 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=acbfaaa9-503c-4691-9828-76a7146ed6de&version=12", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-25", "reviewedAt": "2026-08-25" }, { "id": "src_5ed30b676fbb9773", "label": "FDA Drugs@FDA 官方检索入口（ARIMIDEX；NDA 020541）", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_lookup_entry", "documentKind": "regulatory_lookup", "market": "US", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } ], "applicationNumber": "NDA 020541", "approvalTimeline": [ { "date": "1995", "title": { "zh": "当前标签所列美国初始批准年份", "en": "Initial U.S. approval year listed in the current label" }, "detail": { "zh": "当前 ARIMIDEX 美国公开标签列示 Initial U.S. Approval: 1995。该年份只定位所引美国标签历史，不建立中国大陆、欧盟、日本或其他市场的批准、供应、可售资格、原研/仿制关系或个人适用性。", "en": "The current U.S. ARIMIDEX public label lists Initial U.S. Approval: 1995. This only locates the cited U.S. label history; it does not establish approval, supply, sale eligibility, originator/generic relationship or individual suitability in Mainland China, the EU, Japan or another market." }, "source": { "id": "src_74b020ab375fbc1f", "label": "DailyMed（NLM）：ARIMIDEX 阿那曲唑当前美国公开标签（ANI Pharmaceuticals；SPL v12）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=acbfaaa9-503c-4691-9828-76a7146ed6de&version=12", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-25", "reviewedAt": "2026-08-25" } }, { "date": "2026-03-02", "title": { "zh": "当前 SPL v12 生效日期", "en": "Current SPL v12 effective date" }, "detail": { "zh": "DailyMed 当前 ARIMIDEX 公开标签的 Effective Time 为 2026-03-02，处方信息修订为 2026-03。本页只展示 1 mg、NDC 62559-670-30 与 30 片瓶装面板；不建立实际在售、库存、购买、个人片数、疗程、联用、停用、换药或其他市场状态。", "en": "The current DailyMed ARIMIDEX public label has an effective time of 2 Mar 2026 and prescribing information revised in Mar 2026. This page only displays the 1 mg/NDC 62559-670-30/30-tablet bottle panel; it does not establish actual availability, stock, purchase, individual tablet count, treatment duration, co-use, stopping, switching or another-market status." }, "source": { "id": "src_74b020ab375fbc1f", "label": "DailyMed（NLM）：ARIMIDEX 阿那曲唑当前美国公开标签（ANI Pharmaceuticals；SPL v12，2026-03-02 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=acbfaaa9-503c-4691-9828-76a7146ed6de&version=12", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-25", "reviewedAt": "2026-08-25" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "已链接当前公开标签与准确 30 片瓶装面板", "en": "Current public label and exact 30-tablet bottle panel linked" }, "detail": { "zh": "本页展示 ARIMIDEX 阿那曲唑 1 mg、NDC 62559-670-30、30 片瓶装。它不用于鉴定真伪，也不建立实际在售、库存、购买、个人片数、疗程、开始、停用、联用、换药或可替代性。", "en": "This page displays ARIMIDEX anastrozole 1 mg/NDC 62559-670-30/30-tablet bottle. It does not authenticate a product or establish actual availability, stock, purchase, individual tablet count, treatment duration, initiation, stopping, co-use, switching or interchangeability." } }, { "market": { "zh": "中国大陆、欧盟、日本及其他市场", "en": "Mainland China, EU, Japan and other markets" }, "status": { "zh": "待逐项建立市场记录", "en": "Market record not established" }, "detail": { "zh": "不从美国标签、NDA、NDC、英文品牌、包装图或标签主体推定当地商品名、批准、包装、供应、可售资格、原研/仿制关系或可替代性；每个市场均须按当地现行监管资料单独核对。", "en": "No local trade name, approval, packaging, supply, sale eligibility, originator/generic relationship or interchangeability is inferred from the U.S. label, NDA, NDC, English brand, package image or label entity; every market requires separate checking against current local regulatory material." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "1 mg 与 30 片瓶装能不能用来自己决定片数、疗程，或换到另一种内分泌治疗产品？", "en": "Can 1 mg and a 30-tablet bottle be used to decide my own tablet count, treatment duration or switch to another endocrine therapy product?" }, "answer": { "zh": "不能。这些字段只识别所引美国标签中的准确 ARIMIDEX 片剂和包装。相近毫克数、包装照片、共同诊断或同属内分泌治疗范围，均不建立自行开始、增加、补用、停用、联用、轮换或替代关系；请带现行药盒、处方和完整药单请开方团队或药师复核。", "en": "No. These fields only identify the exact ARIMIDEX tablets and package in the cited U.S. label. A nearby milligram number, package photo, shared diagnosis or endocrine-therapy context does not establish self-initiation, increase, make-up use, stopping, co-use, alternation or substitution; take the current pack, prescription and complete medicine list to the prescribing team or pharmacist for review." } }, { "question": { "zh": "为什么页面提到骨密度、心血管、肝功能和联用药，却不告诉我是否该改药？", "en": "Why does the page mention bone density, cardiovascular concerns, liver function and co-medications without telling me whether to change medicine?" }, "answer": { "zh": "这些是当前美国标签中警示、注意事项和患者咨询段落的阅读入口，不是个体化风险判断或治疗决策。出现急性严重不适或对现行处方有担忧时，请使用当地医疗支持；开方团队或药师需要结合准确产品、病史、检查和完整药单逐项复核。", "en": "These are reading entry points for the current U.S. label's warnings, precautions and patient-counselling sections, not an individual risk assessment or treatment decision. For an acute serious concern or worry about the current prescription, use local medical support; the prescribing team or pharmacist needs the exact product, history, tests and complete medicine list for item-by-item review." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "dosage-forms-are-part-of-medicine-identity", "how-to-read-a-drug-label" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/arimidex/", "en": "https://origindrug.com/en/drugs/arimidex/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "femara", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-25", "status": "published_traceable_archive" }, "names": { "brand": "FEMARA", "generic": "来曲唑", "aliases": [ "FEMARA", "letrozole", "来曲唑" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "肿瘤与血液", "sourceArchiveMarket": "美国：DailyMed 当前 FEMARA 公开标签（SPL v32，2026-06-11 更新）列示来曲唑 2.5 mg 口服薄膜衣片、NDC 0078-0249-15 与 30 片塑料瓶装。该文件不建立中国大陆、欧盟、日本或其他市场的商品名、批准、供应、可售资格、原研/仿制关系或可替代性。", "dosageFormClass": "来曲唑口服薄膜衣片：每片 2.5 mg（美国当前公开标签所列；30 片塑料瓶装）", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "1997（当前美国公开标签所列 Initial U.S. Approval）", "archiveSponsorText": "Novartis Pharmaceuticals Corporation（所引美国公开标签所列标签方）" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [ "anastrozole", "阿那曲唑", "exemestane", "依西美坦", "tamoxifen", "他莫昔芬", "other letrozole package", "其他来曲唑包装" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-femara-letrozole-tablet-2-5mg-30-bottle-ndc-0078-0249-15", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（SPL v32；2026-06-11 更新）", "en": "Current U.S. DailyMed public label (SPL v32; updated 11 Jun 2026)" }, "dosageForm": { "zh": "FEMARA 来曲唑口服薄膜衣片", "en": "FEMARA letrozole film-coated oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 0078-0249-15", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片来曲唑 2.5 mg；30 片塑料瓶装", "en": "Letrozole 2.5 mg per tablet; 30-tablet plastic bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=femara-07.jpg&setid=82b77d74-085f-45ac-a7dd-1f5c038bf406", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "来曲唑", "en": "letrozole" }, "value": 2.5, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、疗程、联用、换药或调整规则", "en": "Labelled amount per tablet; not an individual's tablet count, treatment duration, co-use, switching or adjustment rule" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "塑料瓶", "en": "plastic bottle" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-25", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 30, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "深黄色", "en": "dark yellow" }, "shape": { "zh": "圆形、轻微双凸且带斜边薄膜衣片，约 7 mm", "en": "round, slightly biconvex, beveled film-coated tablet, about 7 mm" }, "imprint": "FV / CG", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_c83190fce6eaa308", "label": "DailyMed（NLM）：FEMARA 来曲唑当前美国公开标签（Novartis Pharmaceuticals；SPL v32，2026-06-11 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=82b77d74-085f-45ac-a7dd-1f5c038bf406&version=32", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-25", "reviewedAt": "2026-08-25" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-femara-letrozole-tablet-2-5mg-30-bottle-ndc-0078-0249-15", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=femara-07.jpg&setid=82b77d74-085f-45ac-a7dd-1f5c038bf406", "alt": "FEMARA 来曲唑 2.5 mg、NDC 0078-0249-15、30 片塑料瓶装在美国 DailyMed 当前公开标签中的包装图", "archiveMarket": "美国", "labelVersion": "DailyMed SPL v32（2026-06-11 更新）", "presentation": "FEMARA 来曲唑：每片 2.5 mg，NDC 0078-0249-15，30 片塑料瓶装（美国当前公开标签）。", "notice": "此图只对应美国 DailyMed 当前公开标签中的 FEMARA、来曲唑 2.5 mg、NDC 0078-0249-15 与 30 片塑料瓶装。它只帮助核对品牌、通用名、每片标示量、包装、外观和来源；不用于鉴定真伪，也不代表其他来曲唑包装、阿那曲唑、依西美坦、他莫昔芬、其他内分泌治疗产品、其他市场、当前可得性、原研身份、相等性、可替代性或任何个人的片数、疗程、联用、换药或停药方案。", "source": { "id": "src_c83190fce6eaa308", "label": "DailyMed（NLM）：FEMARA 来曲唑 2.5 mg、30 片塑料瓶装当前美国公开标签面板（Novartis；SPL v32）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=82b77d74-085f-45ac-a7dd-1f5c038bf406&version=32", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-25", "reviewedAt": "2026-08-25" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "FEMARA／来曲唑说明书放大阅读：先认清 2.5 mg、NDC 与 30 片塑料瓶装", "en": "FEMARA label reading: identify 2.5 mg, NDC and the 30-tablet plastic bottle first" }, "summary": { "zh": "本模块只阅读美国 DailyMed 当前标签中的 FEMARA、来曲唑、每片 2.5 mg、准确 NDC、30 片塑料瓶装、外形与警示。它不提供个人片数、用药时间、疗程、同服、停用、换药、分片或购买方案。", "en": "This module reads only FEMARA, letrozole, 2.5 mg per tablet, the exact NDC, 30-tablet plastic bottle, appearance and warnings in the current U.S. DailyMed label. It provides no individual tablet count, timing, treatment duration, co-use, stopping, switching, splitting or purchase plan." }, "checks": [ { "zh": "先同时核对 FEMARA、来曲唑、2.5 mg、实际 NDC、30 片塑料瓶装、深黄色圆片、FV/CG 压印与目标市场。mg 是这个准确片剂每片的标示量，不是网页可计算的个人片数、疗程、与其他内分泌治疗产品换算或联用规则。", "en": "Check FEMARA, letrozole, 2.5 mg, the actual NDC, 30-tablet plastic bottle, dark-yellow round tablet, FV/CG imprint and target market together. mg is the labelled amount in that exact tablet, not a web calculation for tablet count, treatment duration, conversion to another endocrine therapy or co-use." }, { "zh": "当前标签所示片剂无刻痕；颜色、大小、圆形和压印只用于辅助核对，不能鉴定真伪，也不是自行掰开、减量或由一种包装替换另一种的指令。", "en": "The displayed current-label tablet is unscored. Colour, size, round shape and imprint are supporting checks only; they cannot authenticate a product and are not instructions to self-split, reduce use or replace one package with another." }, { "zh": "当前标签把骨密度、胆固醇、疲劳/头晕/嗜睡、肝功能和胚胎-胎儿毒性等列为需要阅读和专业核对的内容。请把实际药盒、全部处方药、非处方药、补充剂与相关检查资料交给开方团队或药师逐项核对；网页不能把这些条目变成个人的“能否继续、联用或更换”结论。", "en": "The current label identifies bone mineral density, cholesterol, fatigue/dizziness/somnolence, liver function and embryo-fetal toxicity as items for reading and professional review. Give the actual pack, all prescription medicines, OTC products, supplements and relevant test information to the prescribing team or pharmacist for item-by-item review; this page cannot turn them into an individual continue, co-use or switching decision." }, { "zh": "出现呼吸困难、面部或喉部肿胀、明显过敏样反应、胸痛、严重或令人担心的不适时，应优先使用当地医疗支持；不要通过同时停换多种药来试探原因。", "en": "With breathing difficulty, swelling of the face or throat, a marked allergy-like reaction, chest pain, or a severe or worrying symptom, prioritise local medical support; do not test the cause by stopping or changing several medicines at once." } ], "source": { "id": "src_c83190fce6eaa308", "label": "DailyMed（NLM）：FEMARA 来曲唑当前美国公开标签（Warnings, Precautions and Patient Counseling；Novartis；SPL v32）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=82b77d74-085f-45ac-a7dd-1f5c038bf406&version=32", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-25", "reviewedAt": "2026-08-25" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "机制阅读：标签所述芳香化酶抑制路径，不是自行选择、替代或联用规则", "en": "Mechanism reading: the label's aromatase-inhibition pathway is not a self-selection, substitution or co-use rule" }, "summary": { "zh": "当前美国标签将来曲唑描述为芳香化酶抑制剂，并说明其降低雌激素合成。这帮助读者理解标签术语；它不能判断某人应否使用、与阿那曲唑、依西美坦或他莫昔芬如何衔接、能否同服、持续多久或是否适合。", "en": "The current U.S. label describes letrozole as an aromatase inhibitor and explains reduced estrogen synthesis. This helps readers understand label language; it cannot decide whether someone should use it, how it relates to anastrozole, exemestane or tamoxifen, whether products can be used together, duration or suitability." }, "checks": [ { "zh": "“芳香化酶抑制剂”“激素受体”或任何一个机制词，不能证明不同产品相等、可替代或可自行叠加；每个实际产品、目标市场标签和完整药单都需要单独核对。", "en": "“Aromatase inhibitor”, “hormone receptor”, or any one mechanism term does not prove that products are equal, interchangeable or suitable for self-directed combining; each actual product, target-market label and complete medicine list needs separate review." }, { "zh": "机制页不把个人诊断、病理结果、年龄、骨密度、心血管病史、肝功能、其他疾病或完整药单简化为“该不该吃、吃多久或换哪一种”的答案；已有检查或基因报告也须由专业人员结合这些资料解释。", "en": "A mechanism page does not reduce an individual's diagnosis, pathology, age, bone density, cardiovascular history, liver function, other conditions or complete medicine list to an answer about whether to use it, duration or what to change to; existing tests or genetic reports also need professional interpretation with those materials." }, { "zh": "不要把机制、包装图或 2.5 mg 数字用于处理急性症状、补用、停用、换药或联用。现实问题必须回到准确产品的现行目标市场标签和开方团队或药师。", "en": "Do not use mechanism, a package image or the 2.5 mg number to handle an acute symptom, make-up use, stopping, switching or co-use. Real questions must return to the current target-market label for the exact product and the prescribing team or pharmacist." } ], "source": { "id": "src_c83190fce6eaa308", "label": "DailyMed（NLM）：FEMARA 来曲唑当前美国公开标签（Clinical Pharmacology；Novartis；SPL v32）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=82b77d74-085f-45ac-a7dd-1f5c038bf406&version=32", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-25", "reviewedAt": "2026-08-25" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "FEMARA", "generic": "来曲唑", "dosageFormClass": "来曲唑口服薄膜衣片：每片 2.5 mg（美国当前公开标签所列；30 片塑料瓶装）" }, "labelSource": { "id": "src_c83190fce6eaa308", "label": "DailyMed（NLM）：FEMARA 来曲唑当前美国公开标签（Novartis；SPL v32，2026-06-11 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=82b77d74-085f-45ac-a7dd-1f5c038bf406&version=32", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-25", "reviewedAt": "2026-08-25" }, "productRoutes": [ { "source": { "id": "src_c83190fce6eaa308", "label": "DailyMed（NLM）：FEMARA 来曲唑当前美国公开标签（Novartis；SPL v32，2026-06-11 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=82b77d74-085f-45ac-a7dd-1f5c038bf406&version=32", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-25", "reviewedAt": "2026-08-25" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-25", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-25", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "DailyMed 的当前 FEMARA（letrozole）美国公开标签列示 2.5 mg 口服薄膜衣片、NDC、30 片塑料瓶装、深黄色圆片外观与 FV/CG 压印。本页帮助读者把商品名、通用名、每片标示量、准确包装、公开电子说明书和药物警戒阅读路径放在一起；不把 mg、包装数量、肿瘤诊断或“同属内分泌治疗”转换为个人片数、疗程、同服、停用、换药、替代或购买结论。", "history": "当前标签列示 Initial U.S. Approval: 1997，更新日期为 2026-06-11。2.5 mg、NDC 0078-0249-15 与 30 片塑料瓶装共同识别所展示的准确美国产品；相近药名、同为芳香化酶抑制剂、相似黄色圆片或其他市场产品，均不能建立与阿那曲唑、依西美坦、他莫昔芬、其他来曲唑包装或其他市场产品的自行互换、合用或换算关系。", "sourceDocuments": [ { "id": "src_c83190fce6eaa308", "label": "DailyMed（NLM）：FEMARA 来曲唑当前美国公开标签（Novartis；SPL v32，2026-06-11 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=82b77d74-085f-45ac-a7dd-1f5c038bf406&version=32", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-25", "reviewedAt": "2026-08-25" }, { "id": "src_5ed30b676fbb9773", "label": "FDA Drugs@FDA 官方检索入口（FEMARA；NDA 020726）", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_lookup_entry", "documentKind": "regulatory_lookup", "market": "US", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } ], "applicationNumber": "NDA 020726", "approvalTimeline": [ { "date": "1997", "title": { "zh": "当前标签所列美国初始批准年份", "en": "Initial U.S. approval year listed in the current label" }, "detail": { "zh": "当前 FEMARA 美国公开标签列示 Initial U.S. Approval: 1997。该年份只定位所引美国标签历史，不建立中国大陆、欧盟、日本或其他市场的批准、供应、可售资格、原研/仿制关系或个人适用性。", "en": "The current U.S. FEMARA public label lists Initial U.S. Approval: 1997. This only locates the cited U.S. label history; it does not establish approval, supply, sale eligibility, originator/generic relationship or individual suitability in Mainland China, the EU, Japan or another market." }, "source": { "id": "src_c83190fce6eaa308", "label": "DailyMed（NLM）：FEMARA 来曲唑当前美国公开标签（Novartis；SPL v32）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=82b77d74-085f-45ac-a7dd-1f5c038bf406&version=32", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-25", "reviewedAt": "2026-08-25" } }, { "date": "2026-06-11", "title": { "zh": "DailyMed 当前 SPL v32 更新日期", "en": "Current DailyMed SPL v32 updated" }, "detail": { "zh": "DailyMed 将当前 FEMARA 公开标签的 Updated 日期列为 2026-06-11，版本为 SPL v32。本页只展示 2.5 mg、NDC 0078-0249-15 与 30 片塑料瓶装面板；不建立实际在售、库存、购买、个人片数、疗程、联用、停用、换药或其他市场状态。", "en": "DailyMed lists 11 Jun 2026 as Updated for the current FEMARA public label, version SPL v32. This page only displays the 2.5 mg/NDC 0078-0249-15/30-tablet plastic-bottle panel; it does not establish actual availability, stock, purchase, individual tablet count, treatment duration, co-use, stopping, switching or another-market status." }, "source": { "id": "src_c83190fce6eaa308", "label": "DailyMed（NLM）：FEMARA 来曲唑当前美国公开标签（Novartis；SPL v32，2026-06-11 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=82b77d74-085f-45ac-a7dd-1f5c038bf406&version=32", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-25", "reviewedAt": "2026-08-25" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "已链接当前公开标签与准确 30 片塑料瓶装面板", "en": "Current public label and exact 30-tablet plastic-bottle panel linked" }, "detail": { "zh": "本页展示 FEMARA 来曲唑 2.5 mg、NDC 0078-0249-15、30 片塑料瓶装。它不用于鉴定真伪，也不建立实际在售、库存、购买、个人片数、疗程、开始、停用、联用、换药或可替代性。", "en": "This page displays FEMARA letrozole 2.5 mg/NDC 0078-0249-15/30-tablet plastic bottle. It does not authenticate a product or establish actual availability, stock, purchase, individual tablet count, treatment duration, initiation, stopping, co-use, switching or interchangeability." } }, { "market": { "zh": "中国大陆、欧盟、日本及其他市场", "en": "Mainland China, EU, Japan and other markets" }, "status": { "zh": "待逐项建立市场记录", "en": "Market record not established" }, "detail": { "zh": "不从美国标签、NDA、NDC、英文品牌、包装图或标签主体推定当地商品名、批准、包装、供应、可售资格、原研/仿制关系或可替代性；每个市场均须按当地现行监管资料单独核对。", "en": "No local trade name, approval, packaging, supply, sale eligibility, originator/generic relationship or interchangeability is inferred from the U.S. label, NDA, NDC, English brand, package image or label entity; every market requires separate checking against current local regulatory material." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "2.5 mg 与 30 片瓶装能不能用来自己决定片数、疗程，或换到另一种内分泌治疗产品？", "en": "Can 2.5 mg and a 30-tablet bottle be used to decide my own tablet count, treatment duration or switch to another endocrine therapy product?" }, "answer": { "zh": "不能。这些字段只识别所引美国标签中的准确 FEMARA 片剂和包装。相近毫克数、包装照片、共同诊断或同属内分泌治疗范围，均不建立自行开始、增加、补用、停用、联用、轮换或替代关系；请带现行药盒、处方和完整药单请开方团队或药师复核。", "en": "No. These fields only identify the exact FEMARA tablets and package in the cited U.S. label. A nearby milligram number, package photo, shared diagnosis or endocrine-therapy context does not establish self-initiation, increase, make-up use, stopping, co-use, alternation or substitution; take the current pack, prescription and complete medicine list to the prescribing team or pharmacist for review." } }, { "question": { "zh": "为什么页面提到骨密度、胆固醇、肝功能和联用药，却不告诉我是否该改药？", "en": "Why does the page mention bone density, cholesterol, liver function and co-medications without telling me whether to change medicine?" }, "answer": { "zh": "这些是当前美国标签中警示、注意事项和患者咨询段落的阅读入口，不是个体化风险判断或治疗决策。出现急性严重不适或对现行处方有担忧时，请使用当地医疗支持；开方团队或药师需要结合准确产品、病史、检查和完整药单逐项复核。", "en": "These are reading entry points for the current U.S. label's warnings, precautions and patient-counselling sections, not an individual risk assessment or treatment decision. For an acute serious concern or worry about the current prescription, use local medical support; the prescribing team or pharmacist needs the exact product, history, tests and complete medicine list for item-by-item review." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "dosage-forms-are-part-of-medicine-identity", "how-to-read-a-drug-label" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/femara/", "en": "https://origindrug.com/en/drugs/femara/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "nolvadex", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-26", "status": "published_traceable_archive" }, "names": { "brand": "NOLVADEX", "generic": "他莫昔芬", "aliases": [ "NOLVADEX", "ノルバデックス", "tamoxifen", "他莫昔芬", "他莫昔芬枸橼酸盐", "tamoxifen citrate", "21800AMX10347", "21800AMX10348" ], "marketBrandNames": [ { "name": "ノルバデックス", "market": { "zh": "日本", "en": "Japan" }, "evidenceStatus": "current_regulatory_record", "note": { "zh": "PMDA 当前产品页列示ノルバデックス錠10mg／20mg、他莫昔芬枸橼酸盐与日本制造销售方。此记录仅用于核对日文商品名、成分、强度、剂型和监管文件入口；不确认其他市场名称、包装、供应、购买资格、真伪或自行换药。", "en": "The current PMDA product page lists NOLVADEX 10 mg/20 mg tablets, tamoxifen citrate and the Japanese marketing authorisation holder. It only supports checking the Japanese trade name, ingredient, strength, form and regulatory-document entry points—not names, packs, supply, purchase eligibility, authenticity or self-directed switching in another market." }, "source": { "id": "src_6c5dab192fe4ed95", "label": "PMDA：ノルバデックス錠10mg／20mg 当前产品页", "url": "https://www.pmda.go.jp/PmdaSearch/rdDetail/iyaku/4291003F1163_1?user=1", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-26", "reviewedAt": "2026-08-26" } } ], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "肿瘤与血液", "sourceArchiveMarket": "日本：PMDA 当前产品页列示ノルバデックス錠10mg／20mg、成分他莫昔芬枸橼酸盐、制造销售方及现行说明书/患者向医药品指南入口。本页不从这份日本记录推定中国大陆、美国、欧盟或其他市场的批准、包装、供应、可售资格、原研/仿制关系或可替代性。", "dosageFormClass": "日本 PMDA 当前说明书所列：他莫昔芬枸橼酸盐薄膜衣口服片，分别为每片他莫昔芬 10 mg、20 mg", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "日本 PMDA 当前说明书记录：10 mg 于 1981-09 销售开始，20 mg 于 1990-06 销售开始（仅定位日本记录）", "archiveSponsorText": "アストラゼネカ株式会社／AstraZeneca K.K.（PMDA 当前产品页所列日本制造销售方）" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [ "NORVASC", "ノルバスク", "络活喜", "amlodipine", "氨氯地平", "other tamoxifen package", "其他他莫昔芬包装" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "jp-nolvadex-tamoxifen-tablet-10mg-21800amx10347", "marketCode": "JP", "labelVersion": { "zh": "PMDA 当前公开说明书（2026-03 修订）", "en": "Current PMDA public label (revised Mar 2026)" }, "dosageForm": { "zh": "ノルバデックス 他莫昔芬枸橼酸盐薄膜衣口服片", "en": "NOLVADEX tamoxifen citrate film-coated oral tablet" }, "route": { "zh": "口服（标签产品身份字段）", "en": "oral (label product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "Japan approval No. 21800AMX10347", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片他莫昔芬 10 mg；日本 PMDA 当前说明书列示产品身份", "en": "Tamoxifen 10 mg per tablet; product identity listed in the current PMDA label" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "他莫昔芬", "en": "tamoxifen" }, "value": 10, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "10 mg 是每片标签标示量；不是个人片数、疗程、换算或换药指令", "en": "10 mg is a labelled amount per tablet; not an individual's tablet count, treatment duration, conversion or switching instruction" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-26", "currentLabelDisplayed": true, "ndcDirectoryListed": false, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": null, "physicalClues": { "color": { "zh": "白色", "en": "white" }, "shape": { "zh": "薄膜衣片；外形与压印仅作辅助核对，不能鉴定真伪或作为自行分片依据", "en": "film-coated tablet; appearance and imprint are supporting checks only, not product authentication or self-splitting instructions" }, "imprint": "NOLVADEX 10", "scoreStatus": "not_established", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_396843a4abc09bb8", "label": "PMDA：ノルバデックス錠10mg／20mg 当前公开说明书（2026-03 修订）", "url": "https://www.pmda.go.jp/PmdaSearch/iyakuDetail/ResultDataSetPDF/670227_4291003F1163_1_20", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-26", "reviewedAt": "2026-08-26" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "jp-nolvadex-tamoxifen-tablet-20mg-21800amx10348", "marketCode": "JP", "labelVersion": { "zh": "PMDA 当前公开说明书（2026-03 修订）", "en": "Current PMDA public label (revised Mar 2026)" }, "dosageForm": { "zh": "ノルバデックス 他莫昔芬枸橼酸盐薄膜衣口服片", "en": "NOLVADEX tamoxifen citrate film-coated oral tablet" }, "route": { "zh": "口服（标签产品身份字段）", "en": "oral (label product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "Japan approval No. 21800AMX10348", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片他莫昔芬 20 mg；日本 PMDA 当前说明书列示产品身份", "en": "Tamoxifen 20 mg per tablet; product identity listed in the current PMDA label" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "他莫昔芬", "en": "tamoxifen" }, "value": 20, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "20 mg 是每片标签标示量；不是个人片数、疗程、换算或换药指令", "en": "20 mg is a labelled amount per tablet; not an individual's tablet count, treatment duration, conversion or switching instruction" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-26", "currentLabelDisplayed": true, "ndcDirectoryListed": false, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": null, "physicalClues": { "color": { "zh": "白色", "en": "white" }, "shape": { "zh": "薄膜衣片；外形与压印仅作辅助核对，不能鉴定真伪或作为自行分片依据", "en": "film-coated tablet; appearance and imprint are supporting checks only, not product authentication or self-splitting instructions" }, "imprint": "NOLVADEX 20", "scoreStatus": "not_established", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_396843a4abc09bb8", "label": "PMDA：ノルバデックス錠10mg／20mg 当前公开说明书（2026-03 修订）", "url": "https://www.pmda.go.jp/PmdaSearch/iyakuDetail/ResultDataSetPDF/670227_4291003F1163_1_20", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-26", "reviewedAt": "2026-08-26" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [ { "id": "jp-nolvadex-tablet-10mg-pmda-guide-2023", "marketCode": "JP", "visualKind": "official_patient_guide_dosage_form_appearance", "title": { "zh": "NOLVADEX 他莫昔芬 10 mg 片：日本官方外观", "en": "NOLVADEX tamoxifen 10 mg tablet: official Japan appearance" }, "imageUrl": "/evidence/medicine/nolvadex/nolvadex-tablet-10mg-pmda-guide-2023.png", "alt": { "zh": "日本 PMDA 患者指南中的 NOLVADEX 10 白色圆片", "en": "White round tablet marked NOLVADEX 10 in the Japanese PMDA patient guide" }, "description": { "zh": "2023 年 5 月患者指南第 5 页原图：印记 NOLVADEX 10，直径 8.1 mm。2026-09-08 核验，保留原图，未增强或重绘。", "en": "Original image on page 5 of the May 2023 patient guide: imprint NOLVADEX 10, diameter 8.1 mm. Checked 2026-09-08; no enhancement or redrawing." }, "exclusions": { "zh": "仅供核对该日本指南的药片外观；不是外盒包装，也不代表中国市场。不能凭图片判断真伪、决定片数或自行掰片换药。", "en": "Tablet appearance in this Japanese guide only, not an outer package or a China-market reference. Images cannot authenticate a medicine or determine tablet count, splitting or switching." }, "source": { "id": "src_2f3e164d1ba4fa21", "label": "PMDA：ノルバデックス錠10mg／20mg 患者向医药品指南（2023-05 更新）", "url": "https://www.info.pmda.go.jp/downfiles/guide/ph/670227_4291003F1163_1_00G.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "patient_medicine_guide", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-08", "reviewedAt": "2026-09-08" }, "scope": "official_dosage_form_appearance_only_not_outer_package_authentication_or_personal_use" }, { "id": "jp-nolvadex-tablet-20mg-pmda-guide-2023", "marketCode": "JP", "visualKind": "official_patient_guide_dosage_form_appearance", "title": { "zh": "NOLVADEX 他莫昔芬 20 mg 片：日本官方外观", "en": "NOLVADEX tamoxifen 20 mg tablet: official Japan appearance" }, "imageUrl": "/evidence/medicine/nolvadex/nolvadex-tablet-20mg-pmda-guide-2023.png", "alt": { "zh": "日本 PMDA 患者指南中的 NOLVADEX 20 白色圆片", "en": "White round tablet marked NOLVADEX 20 in the Japanese PMDA patient guide" }, "description": { "zh": "2023 年 5 月患者指南第 5 页原图：印记 NOLVADEX 20，直径 10.1 mm。2026-09-08 核验，保留原图，未增强或重绘。", "en": "Original image on page 5 of the May 2023 patient guide: imprint NOLVADEX 20, diameter 10.1 mm. Checked 2026-09-08; no enhancement or redrawing." }, "exclusions": { "zh": "仅供核对该日本指南的药片外观；不是外盒包装，也不代表中国市场。不能凭图片判断真伪、决定片数或自行掰片换药。", "en": "Tablet appearance in this Japanese guide only, not an outer package or a China-market reference. Images cannot authenticate a medicine or determine tablet count, splitting or switching." }, "source": { "id": "src_2f3e164d1ba4fa21", "label": "PMDA：ノルバデックス錠10mg／20mg 患者向医药品指南（2023-05 更新）", "url": "https://www.info.pmda.go.jp/downfiles/guide/ph/670227_4291003F1163_1_00G.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "patient_medicine_guide", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-08", "reviewedAt": "2026-09-08" }, "scope": "official_dosage_form_appearance_only_not_outer_package_authentication_or_personal_use" } ], "visualReference": { "status": "withheld_repackaged_or_non_exact_visual", "title": { "zh": "已核验 PMDA 当前说明书文字，但未保留与单一强度、单一包装一一对应的官方包装图，故不展示包装图片", "en": "The current PMDA label text was reviewed, but no official package image matching one exact strength and pack was retained, so no package visual is shown" }, "summary": { "zh": "本档案保留日本 PMDA 当前文件中的 NOLVADEX／ノルバデックス、他莫昔芬枸橼酸盐、10 mg／20 mg、两个承认番号、说明书及患者向医药品指南入口。此次没有保留能与单一强度和单一包装逐一对应、可安全公开展示的官方包装图；为避免把版本不明图、零售图、其他市场图或另一强度图片误作准确产品，页面不展示包装图片，只保留可放大阅读的官方电子说明书。", "en": "This dossier retains NOLVADEX/ノルバデックス, tamoxifen citrate, 10 mg/20 mg, two approval numbers, the current PMDA label and patient-medicine-guide entry points. This review did not retain an official package image that can safely be matched one-to-one to a single strength and pack; to avoid presenting a version-uncertain image, retail image, another-market image or another-strength image as the exact product, the page withholds package imagery and retains the official electronic leaflet for enlarged reading." }, "source": { "id": "src_396843a4abc09bb8", "label": "PMDA：ノルバデックス錠10mg／20mg 当前说明书（2026-03 修订）", "url": "https://www.pmda.go.jp/PmdaSearch/iyakuDetail/ResultDataSetPDF/670227_4291003F1163_1_20", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-26", "reviewedAt": "2026-08-26" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "NOLVADEX／他莫昔芬说明书放大阅读：先把完整名称、mg 与市场一起核对", "en": "NOLVADEX label reading: check the full name, mg and market together first" }, "summary": { "zh": "本模块只阅读日本 PMDA 当前 NOLVADEX 说明书和患者向医药品指南中的产品身份与安全阅读入口。它不提供个人片数、疗程、漏用处理、分片、同服、停用、换药或购买方案。", "en": "This module only reads product-identity and safety-reading entries in the current Japanese PMDA NOLVADEX label and patient guide. It provides no individual tablet count, treatment duration, missed-use handling, splitting, co-use, stopping, switching or purchase plan." }, "checks": [ { "zh": "先同时核对完整商品名 NOLVADEX／ノルバデックス、通用名他莫昔芬、每片 10 mg 或 20 mg、薄膜衣口服片、目标市场和现行处方。mg 是准确片剂的标签标示量，不是网页可计算的个人片数、疗程或两种强度间换算规则。", "en": "Check the full NOLVADEX/ノルバデックス name, generic tamoxifen, 10 mg or 20 mg per tablet, film-coated oral-tablet form, target market and current prescription together. mg is a labelled amount for an exact tablet, not a web calculation for an individual's tablet count, duration or conversion between strengths." }, { "zh": "ノルバデックス与ノルバスク（NORVASC）只相差少量文字，不能凭部分读音、颜色或“同为片剂”自行判断为同一种药。若名称、药盒、市场或强度有任何不清楚，应核对完整商品名、通用名、强度、剂型与可访问的来源文件，并把实际药盒和完整药单交给药师或开方团队。", "en": "ノルバデックス and ノルバスク (NORVASC) differ by only a small amount of text; a partial sound, colour or the fact that both are tablets cannot establish that they are the same medicine. If the name, pack, market or strength is unclear, check the full trade name, generic name, strength, form and accessible source document, and have a pharmacist or prescriber review the actual pack and complete medicine list." }, { "zh": "患者向医药品指南用于帮助患者和家属理解医药品及尽早识别可能的严重不良反应；它不能取代处方、治疗团队或个体化风险判断。怀孕/可能怀孕、哺乳、既往病史、其他处方药、非处方药和补充剂都应在实际使用前由负责团队逐项核对。", "en": "A patient medicine guide helps patients and families understand a medicine and recognise possible serious adverse reactions early; it does not replace a prescription, treatment team or individual risk assessment. Pregnancy/possible pregnancy, breast-feeding, history, other prescription medicines, OTC products and supplements require item-by-item review by the responsible team before actual use." }, { "zh": "出现呼吸困难、面部或喉部肿胀、胸痛、单侧肢体突然肿痛、突然神经系统变化或其他急性严重不适时，应优先使用当地紧急医疗支持；不要通过自行同时停换多种药来试探原因。", "en": "With breathing difficulty, swelling of the face or throat, chest pain, sudden one-sided limb swelling/pain, sudden neurologic change or another acute serious concern, prioritise local emergency medical support; do not test the cause by stopping or changing several medicines yourself." } ], "source": { "id": "src_6c5dab192fe4ed95", "label": "PMDA：ノルバデックス錠10mg／20mg 当前说明书及患者向医药品指南", "url": "https://www.pmda.go.jp/PmdaSearch/rdDetail/iyaku/4291003F1163_1?user=1", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-26", "reviewedAt": "2026-08-26" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "他莫昔芬怎样起作用：受体相关的说明不能替代个人治疗决定", "en": "How tamoxifen works: a receptor-related explanation cannot replace an individual treatment decision" }, "summary": { "zh": "PMDA 患者向医药品指南将本品归为内分泌治疗相关药物，并描述其通过作用于雌激素受体来抑制乳腺癌细胞增殖。它是监管文件中的机制阅读线索，不判断任何人的病理结果、是否适用、片数、疗程、与阿那曲唑/来曲唑或其他产品的衔接、同服或换药。", "en": "The PMDA patient guide classifies this medicine in endocrine-therapy-related treatment and describes action on estrogen receptors to suppress breast-cancer-cell proliferation. This is a regulatory-document mechanism-reading cue, not a decision about anyone's pathology, suitability, tablet count, duration, sequencing with anastrozole/letrozole or another product, co-use or switching." }, "checks": [ { "zh": "“雌激素受体”“内分泌治疗”或相同疾病名称，不能把 NOLVADEX、ARIMIDEX、FEMARA 或其他治疗产品变成可自行替换、叠加、交替或按 mg 换算的关系。准确产品、市场、检查资料与完整药单须由肿瘤团队整体核对。", "en": "“Estrogen receptor”, “endocrine therapy” or a shared disease name does not make NOLVADEX, ARIMIDEX, FEMARA or another treatment self-switchable, combinable, alternatable or convertible by mg. Exact products, market, test materials and the complete medicine list require oncology-team review together." }, { "zh": "机制说明不是解释个人乳腺影像、病理、激素受体、基因报告或复发风险的工具，也不能替代对既往治疗、妊娠可能性、合并疾病、器官功能和全部联用药物的评估。", "en": "A mechanism explanation is not a tool for interpreting an individual's breast imaging, pathology, hormone receptors, genetic report or recurrence risk, and cannot replace assessment of prior treatment, pregnancy possibility, coexisting conditions, organ function and all co-medications." }, { "zh": "不要用机制或说明书数字处理急性症状、漏用、停用、补用、联用或换药。实际问题必须回到准确产品的现行目标市场标签和负责治疗团队或药师。", "en": "Do not use mechanism or label numbers to handle an acute symptom, missed use, stopping, make-up use, co-use or switching. Real questions must return to the current target-market label for the exact product and the responsible treatment team or pharmacist." } ], "source": { "id": "src_2f3e164d1ba4fa21", "label": "PMDA：ノルバデックス錠10mg／20mg 患者向医药品指南（2023-05 更新）", "url": "https://www.info.pmda.go.jp/downfiles/guide/ph/670227_4291003F1163_1_00G.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "patient_medicine_guide", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-08", "reviewedAt": "2026-09-08" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "NOLVADEX", "generic": "他莫昔芬", "dosageFormClass": "日本 PMDA 当前说明书所列：他莫昔芬枸橼酸盐薄膜衣口服片，分别为每片他莫昔芬 10 mg、20 mg" }, "labelSource": { "id": "src_6c5dab192fe4ed95", "label": "PMDA：ノルバデックス錠10mg／20mg 当前产品页", "url": "https://www.pmda.go.jp/PmdaSearch/rdDetail/iyaku/4291003F1163_1?user=1", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-26", "reviewedAt": "2026-08-26" }, "productRoutes": [ { "source": { "id": "src_6c5dab192fe4ed95", "label": "PMDA：ノルバデックス錠10mg／20mg 当前产品页", "url": "https://www.pmda.go.jp/PmdaSearch/rdDetail/iyaku/4291003F1163_1?user=1", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-26", "reviewedAt": "2026-08-26" }, "status": "product_level_public_record_verified", "authority": { "zh": "PMDA", "en": "PMDA" }, "market": { "zh": "日本", "en": "Japan" }, "recordType": { "zh": "监管产品记录", "en": "Regulatory product record" }, "reviewedAt": "2026-08-26", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_396843a4abc09bb8", "label": "PMDA：ノルバデックス錠10mg／20mg 当前说明书（2026-03 修订）", "url": "https://www.pmda.go.jp/PmdaSearch/iyakuDetail/ResultDataSetPDF/670227_4291003F1163_1_20", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-26", "reviewedAt": "2026-08-26" }, "status": "product_level_public_record_verified", "authority": { "zh": "PMDA", "en": "PMDA" }, "market": { "zh": "日本", "en": "Japan" }, "recordType": { "zh": "监管产品记录", "en": "Regulatory product record" }, "reviewedAt": "2026-08-26", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "PMDA", "en": "PMDA" }, "market": { "zh": "日本", "en": "Japan" }, "recordType": { "zh": "监管产品记录", "en": "Regulatory product record" }, "reviewedAt": "2026-08-26", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "日本 PMDA 当前记录列示 NOLVADEX（ノルバデックス）他莫昔芬枸橼酸盐 10 mg、20 mg 薄膜衣口服片及患者向医药品指南。页面帮助读者把品牌、通用名、每片标示量、目标市场和官方电子说明书放在一起阅读；不把 mg、产品名、历史年份或肿瘤类型转成个人片数、疗程、同服、停用、换药、替代或购买结论。", "history": "PMDA 现行说明书（2026-03 修订）列示日本销售开始时间：10 mg 为 1981-09，20 mg 为 1990-06。该时间线只定位日本监管文件中的产品历史；10 mg 与 20 mg 是各自片剂的标示量，不建立个人片数、强度换算、不同内分泌治疗产品的互换或跨市场包装结论。", "sourceDocuments": [ { "id": "src_6c5dab192fe4ed95", "label": "PMDA：ノルバデックス錠10mg／20mg 当前产品页", "url": "https://www.pmda.go.jp/PmdaSearch/rdDetail/iyaku/4291003F1163_1?user=1", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-26", "reviewedAt": "2026-08-26" }, { "id": "src_396843a4abc09bb8", "label": "PMDA：ノルバデックス錠10mg／20mg 当前说明书（2026-03 修订）", "url": "https://www.pmda.go.jp/PmdaSearch/iyakuDetail/ResultDataSetPDF/670227_4291003F1163_1_20", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-26", "reviewedAt": "2026-08-26" }, { "id": "src_2f3e164d1ba4fa21", "label": "PMDA：ノルバデックス錠10mg／20mg 患者向医药品指南（2023-05 更新）", "url": "https://www.info.pmda.go.jp/downfiles/guide/ph/670227_4291003F1163_1_00G.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "patient_medicine_guide", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-08", "reviewedAt": "2026-09-08" } ], "applicationNumber": "日本 PMDA 承认番号：ノルバデックス錠10mg 21800AMX10347；ノルバデックス錠20mg 21800AMX10348（当前 PMDA 说明书所列；只定位日本监管记录）", "approvalTimeline": [ { "date": "1981-09", "title": { "zh": "日本 PMDA 当前说明书所列：10 mg 销售开始", "en": "10 mg marketing start listed in the current Japanese PMDA label" }, "detail": { "zh": "PMDA 当前说明书列示ノルバデックス錠10mg 的销售开始为 1981-09。该历史节点只定位日本说明书中的产品记录；不建立当前供应、可售资格、其他市场状态、原研/仿制关系、可替代性或个人适用性。", "en": "The current PMDA label lists Sep 1981 as the marketing start for NOLVADEX 10 mg. This historical node only locates the product record in the Japanese label; it does not establish current supply, sale eligibility, another-market status, originator/generic relationship, interchangeability or individual suitability." }, "source": { "id": "src_396843a4abc09bb8", "label": "PMDA：ノルバデックス錠10mg／20mg 当前说明书（2026-03 修订）", "url": "https://www.pmda.go.jp/PmdaSearch/iyakuDetail/ResultDataSetPDF/670227_4291003F1163_1_20", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-26", "reviewedAt": "2026-08-26" } }, { "date": "1990-06", "title": { "zh": "日本 PMDA 当前说明书所列：20 mg 销售开始", "en": "20 mg marketing start listed in the current Japanese PMDA label" }, "detail": { "zh": "PMDA 当前说明书列示ノルバデックス錠20mg 的销售开始为 1990-06。该历史节点只定位日本说明书中的产品记录；不建立当前供应、可售资格、其他市场状态、原研/仿制关系、可替代性或个人适用性。", "en": "The current PMDA label lists Jun 1990 as the marketing start for NOLVADEX 20 mg. This historical node only locates the product record in the Japanese label; it does not establish current supply, sale eligibility, another-market status, originator/generic relationship, interchangeability or individual suitability." }, "source": { "id": "src_396843a4abc09bb8", "label": "PMDA：ノルバデックス錠10mg／20mg 当前说明书（2026-03 修订）", "url": "https://www.pmda.go.jp/PmdaSearch/iyakuDetail/ResultDataSetPDF/670227_4291003F1163_1_20", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-26", "reviewedAt": "2026-08-26" } }, { "date": "2026-03-17", "title": { "zh": "PMDA 当前说明书修订记录", "en": "Current PMDA label revision record" }, "detail": { "zh": "PMDA 当前产品页指向 2026-03-17 的说明书文件与患者向医药品指南入口。此日期用于定位可复核文件版本，不是个人用药、包装供应、购买或其他市场状态的结论。", "en": "The current PMDA product page links the 17 Mar 2026 label and patient-medicine-guide entry point. This date locates a reviewable document version; it is not a conclusion about individual use, package supply, purchase or another-market status." }, "source": { "id": "src_6c5dab192fe4ed95", "label": "PMDA：ノルバデックス錠10mg／20mg 当前产品页", "url": "https://www.pmda.go.jp/PmdaSearch/rdDetail/iyaku/4291003F1163_1?user=1", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-26", "reviewedAt": "2026-08-26" } } ], "marketStatus": [ { "market": { "zh": "日本", "en": "Japan" }, "status": { "zh": "已链接 PMDA 当前产品页、说明书、患者向医药品指南及两个片剂身份", "en": "Current PMDA product page, label, patient guide and two tablet identities linked" }, "detail": { "zh": "本页只分别记录日本 PMDA 当前文件中的ノルバデックス錠10mg（承认番号 21800AMX10347）与20mg（21800AMX10348）、每片标签标示量和官方文件入口；不用于鉴定真伪，也不建立实际在售、库存、购买、个人片数、疗程、联用、停用、换药或可替代性。", "en": "This page separately records only NOLVADEX 10 mg (approval No. 21800AMX10347) and 20 mg (21800AMX10348), labelled amount per tablet and official-document entry points in current Japanese PMDA materials; it does not authenticate a product or establish actual marketing, stock, purchase, individual tablet count, duration, co-use, stopping, switching or interchangeability." } }, { "market": { "zh": "中国大陆、美国、欧盟及其他市场", "en": "Mainland China, the United States, the EU and other markets" }, "status": { "zh": "待逐项建立现行市场记录", "en": "Current market record not established" }, "detail": { "zh": "不从日本 PMDA 的品牌、承认番号、历史销售开始时间、说明书、患者指南或制造销售方推定当地商品名、批准、包装、供应、可售资格、原研/仿制关系或可替代性；每个市场均须按当地现行监管资料单独核对。", "en": "No local trade name, approval, package, supply, sale eligibility, originator/generic relationship or interchangeability is inferred from Japanese PMDA brand, approval numbers, historical marketing-start dates, label, patient guide or marketing-authorisation holder; each market requires separate checking against current local regulatory material." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "10 mg、20 mg 与日本承认番号能否告诉我该吃几片、能否换成其他内分泌治疗药？", "en": "Can 10 mg, 20 mg and Japanese approval numbers tell me how many to take or whether I can change to another endocrine treatment?" }, "answer": { "zh": "不能。这些字段只识别 PMDA 当前文件中的准确日本片剂。共同治疗领域、相近 mg 数字、相似名称、说明书或包装外观都不建立自行开始、增加、补用、停用、联用、交替、换算或替代关系；请带实际药盒、现行处方和完整药单请肿瘤团队或药师核对。", "en": "No. These fields only identify the exact Japanese tablets in current PMDA materials. A shared treatment area, nearby mg number, similar name, label or package appearance does not establish self-initiation, increase, make-up use, stopping, co-use, alternation, conversion or substitution; have the oncology team or pharmacist review the actual pack, current prescription and complete medicine list." } }, { "question": { "zh": "为什么页面提示ノルバデックス与ノルバスク名称相似，却不告诉我是否可以停药或换药？", "en": "Why does the page flag similar NOLVADEX/NORVASC names without telling me whether to stop or change medicine?" }, "answer": { "zh": "名称相似提醒的作用是防止把不确定的药盒误读成另一种药，不是治疗决定。不要根据部分读音、颜色、网络照片或网页自行停、换、合用或增加任何药；若怀疑拿错、出现急性严重不适或需要核对实际处方，应优先联系当地医疗支持或负责团队。", "en": "A similar-name reminder helps prevent an uncertain pack from being misread as another medicine; it is not a treatment decision. Do not self-stop, change, combine or increase any medicine from a partial sound, colour, online photo or webpage; with a suspected mix-up, acute serious concern or need to check an actual prescription, prioritise local medical support or the responsible team." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "dosage-forms-are-part-of-medicine-identity", "how-to-read-a-drug-label" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/nolvadex/", "en": "https://origindrug.com/en/drugs/nolvadex/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "prolia", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-16", "status": "published_traceable_archive" }, "names": { "brand": "Prolia", "generic": "地舒单抗", "aliases": [ "denosumab" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "骨骼健康", "sourceArchiveMarket": "美国公开监管档案", "dosageFormClass": "皮下注射液（60 mg/mL 单剂量预充注射器；FDA 2025 标签所列）", "dosageFormClassCode": "subcutaneous_injection", "route": "皮下注射", "routeCode": "subcutaneous", "historicalApprovalEntry": "2010（FDA 2025 标签所列美国初始批准）", "archiveSponsorText": "FDA 公开监管档案" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-prolia-denosumab-60mg-1ml-single-dose-prefilled-syringe-ndc-55513-710-21", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v186；标签生效 2026-06-26", "en": "DailyMed SPL v186; label effective 26 Jun 2026" }, "dosageForm": { "zh": "地舒单抗注射液；单剂量预充注射器", "en": "denosumab injection; single-dose prefilled syringe" }, "route": { "zh": "皮下（标签所列途径；不由网页决定个人给药）", "en": "subcutaneous (labelled route; this page does not determine an individual's administration)" }, "routeCodes": [ "subcutaneous" ], "productCode": "NDC 55513-710-21", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "concentration", "primaryDisplay": { "zh": "60 mg/1 mL（60 mg/mL）；1 支单剂量预充注射器纸盒", "en": "60 mg/1 mL (60 mg/mL); one single-dose prefilled-syringe carton" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=prolia-09.jpg&setid=49e5afe9-a0c7-40c4-af9f-f287a80c5c88&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "地舒单抗", "en": "denosumab" }, "value": 60, "unit": "mg", "basisCode": "concentration", "basisLabel": { "zh": "60 mg/mL 标签浓度；不是个人注射量或换算指令", "en": "60 mg/mL labelled concentration; not an individual's injection amount or conversion instruction" } }, { "ingredient": { "zh": "地舒单抗", "en": "denosumab" }, "value": 60, "unit": "mg", "basisCode": "per_single_dose_syringe", "basisLabel": { "zh": "每支 1 mL 单剂量预充注射器标示量；不是个人注射指令", "en": "labelled amount in one 1 mL single-dose prefilled syringe; not an individual administration instruction" } } ], "concentration": { "basisCode": "mass_per_volume", "notation": "60 mg/mL", "numerator": { "value": 60, "unit": "mg" }, "denominator": { "value": 1, "unit": "mL" }, "display": { "zh": "60 mg/mL（标签浓度；不是个人注射量）", "en": "60 mg/mL (labelled concentration; not an individual injection amount)" } }, "container": { "typeCode": "single_dose_prefilled_syringe", "typeLabel": { "zh": "单剂量预充注射器（带安全装置）", "en": "single-dose prefilled syringe with safety guard" }, "fill": { "value": 1, "unit": "mL" }, "countPerPackage": 1, "countUnit": { "zh": "支单剂量预充注射器/纸盒", "en": "single-dose prefilled syringe per carton" } }, "deliveryDevice": { "typeCode": "safety_guard", "name": { "zh": "安全装置", "en": "safety guard" } }, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-25", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 1, "unit": { "zh": "支单剂量预充注射器/纸盒", "en": "single-dose prefilled syringe per carton" } }, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_9fe61a483b99938c", "label": "DailyMed（NLM）：PROLIA 公开标签（Amgen；SPL v186，标签生效 2026-06-26）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=49e5afe9-a0c7-40c4-af9f-f287a80c5c88", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-prolia-denosumab-60mg-1ml-single-dose-prefilled-syringe-ndc-55513-710-21", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=prolia-09.jpg&setid=49e5afe9-a0c7-40c4-af9f-f287a80c5c88&type=img", "alt": "PROLIA 60 mg/mL 单剂量预充注射器在美国 DailyMed 公开标签中的包装标签图", "archiveMarket": "美国", "labelVersion": "2026-06", "presentation": "PROLIA 60 mg/mL 单剂量预充注射器包装标签图（DailyMed 页面所列 2026-06 更新标签）。", "notice": "此为美国 DailyMed 公开标签中明确对应 PROLIA 60 mg/mL 单剂量预充注射器的包装文字图，只帮助核对品牌、通用名、标示强度、给药途径、装置和来源；不用于鉴定真伪，也不证明其他市场标签、当前包装、目标市场批准或可售资格。", "source": { "id": "src_9fe61a483b99938c", "label": "DailyMed（NLM）：PROLIA 公开标签（2026-06 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=49e5afe9-a0c7-40c4-af9f-f287a80c5c88", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "PROLIA 说明书放大阅读：60 mg/mL 是产品强度，不是自行安排注射的答案", "en": "PROLIA label reading: 60 mg/mL is product strength, not an answer for self-scheduling an injection" }, "summary": { "zh": "本模块以 FDA 2025 美国标签为阅读入口，帮助理解 PROLIA 预充注射器的通用名、强度和给药途径；它不制定个人注射、补钙/维生素 D、延后或停用方案。", "en": "This module uses the 2025 U.S. FDA label as a reading entry point. It helps read a PROLIA prefilled syringe's generic name, strength and route; it does not create an individual injection, calcium/vitamin D, delay or stopping plan." }, "checks": [ { "zh": "标签所列“60 mg/mL 单剂量预充注射器”同时描述强度、浓度和包装形式。它不是个人应何时注射、能否提前/延后或可否用另一盒注射剂替代的结论。", "en": "The label's “60 mg/mL single-dose prefilled syringe” describes strength, concentration and package form together. It does not determine when any individual should be injected, whether it can be advanced or delayed, or whether another injectable can replace it." }, { "zh": "该标签把低钙血症、肾功能相关风险及开始前评估列为重要内容。尤其存在晚期慢性肾病、近期检验变化或多种药物时，不应仅按网页、包装或既往习惯自行开始、延后、停用或补充产品。", "en": "The label identifies hypocalcaemia, kidney-related risk and assessment before initiation as important matters. Especially with advanced chronic kidney disease, recent test changes or multiple medicines, do not independently start, delay, stop or add products from a webpage, package or past routine alone." }, { "zh": "标签明确提示：正在使用 PROLIA 的人不应同时使用其他含地舒单抗的产品。这是需要对照完整药单与准确产品的安全核验点，不是读者自行判断另一药是否“同成分”或自行停换的依据。", "en": "The label states that people receiving PROLIA should not also receive another denosumab product. This is a safety check requiring the complete medicine list and exact product, not a basis for self-deciding whether another medicine is “the same ingredient” or for self-switching or stopping." }, { "zh": "照片、针筒颜色和包装文字只用于定位来源。不同市场、标签版本和包装可能不同；图片不能鉴定真伪、确认当前批准或代替出现抽搐、麻刺感、严重不适等情况的及时医疗评估。", "en": "Photos, syringe colour and package wording only help locate a source. Markets, label versions and packages can differ; an image cannot authenticate a product, confirm current approval or replace prompt medical assessment for symptoms such as spasms, tingling or severe illness." } ], "source": { "id": "src_5bf3f2f89ac96a4c", "label": "FDA：PROLIA 2025-05 处方信息（BLA 125320）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/125320s219lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "地舒单抗怎样起作用：它阻断 RANKL 与 RANK 的结合", "en": "How denosumab works: it blocks the RANKL-RANK interaction" }, "summary": { "zh": "DailyMed 的 PROLIA 标签说明，地舒单抗与 RANKL 结合，阻止其激活破骨细胞及其前体表面的 RANK；由此抑制破骨细胞的形成、功能和存活，并减少骨吸收。它解释的是一条骨重塑相关路径，不判断个人是否需要注射、何时注射、钙和维生素 D 如何补充、是否停用或如何衔接其他骨骼用药。", "en": "The DailyMed PROLIA label says denosumab binds RANKL and prevents activation of RANK on osteoclasts and their precursors; this inhibits osteoclast formation, function and survival and reduces bone resorption. It explains a bone-remodelling pathway, not whether an individual needs injection, when to inject, how to use calcium or vitamin D, whether to stop, or how to sequence another bone medicine." }, "checks": [ { "zh": "“影响破骨细胞”不能决定个人是否适合开始、延后、漏用后补用或停止 PROLIA，也不能替代对骨折风险、肾功能、钙/维生素 D、牙科问题、既往治疗和完整药单的评估。", "en": "“Affects osteoclasts” cannot decide whether an individual should start, delay, redose after a missed treatment or stop PROLIA, and cannot replace assessment of fracture risk, kidney function, calcium/vitamin-D status, dental issues, prior treatment and the complete medicine list." }, { "zh": "同样作用于骨骼，或名称中都含“抗骨吸收”，不表示 PROLIA 能与双膦酸盐、其他地舒单抗产品、钙剂或维生素制剂自行叠加、轮换或替代。每个产品、给药途径、时间安排和实验室检查都需由专业团队确认。", "en": "Acting on bone, or having a name that suggests antiresorption, does not make PROLIA self-combinable, alternatable or substitutable with a bisphosphonate, another denosumab product, calcium or vitamin preparation. Every product, route, timing plan and laboratory check requires professional confirmation." }, { "zh": "标签对进展期肾病相关低钙风险有特别警示。抽搐、明显肌肉痉挛/抽动、麻木刺痛、意识改变或其他急性严重不适，应及时使用当地紧急医疗支持；不要从机制页面自行补钙、改药或跳过评估。", "en": "The label gives a particular warning about hypocalcaemia risk related to advanced kidney disease. With seizure, marked muscle spasm/twitching, numbness or tingling, mental-status change or another acute severe concern, use timely local emergency support; do not self-supplement calcium, change medicine or skip evaluation from a mechanism page." } ], "source": { "id": "src_9fe61a483b99938c", "label": "DailyMed（NLM）：PROLIA 公开标签（Amgen，2026-06 修订；临床药理）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=49e5afe9-a0c7-40c4-af9f-f287a80c5c88", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "Prolia", "generic": "地舒单抗", "dosageFormClass": "皮下注射液（60 mg/mL 单剂量预充注射器；FDA 2025 标签所列）" }, "labelSource": { "id": "src_5bf3f2f89ac96a4c", "label": "FDA：PROLIA 2025-05 美国标签（BLA 125320）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/125320s219lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "productRoutes": [ { "source": { "id": "src_5bf3f2f89ac96a4c", "label": "FDA：PROLIA 2025-05 美国标签（BLA 125320）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/125320s219lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_9fe61a483b99938c", "label": "DailyMed（NLM）：PROLIA 公开标签（2026-06 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=49e5afe9-a0c7-40c4-af9f-f287a80c5c88", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [ { "id": "fda-2024-prolia-advanced-ckd-severe-hypocalcemia-boxed-warning", "issuedAt": "2024-01-19", "status": "fda_drug_safety_communication", "title": { "zh": "FDA 药物安全通讯：Prolia（地舒单抗）在晚期慢性肾病患者中的严重低钙血症黑框警告", "en": "FDA Drug Safety Communication: Boxed Warning for severe hypocalcemia with Prolia (denosumab) in advanced chronic kidney disease" }, "summary": { "zh": "FDA 于 2024-01-19 发布安全通讯，说明其完成审查后在美国 Prolia（地舒单抗）处方信息中加入晚期慢性肾病患者严重低钙血症风险的黑框警告；公告特别讨论透析患者及伴慢性肾病矿物质和骨异常者。这是美国、特定产品和特定人群的监管信息，不可据此判断任何人是否属于该人群、是否应接受检测/监测或是否应开始、延后、停止或改用产品。请以目标市场现行说明书、实际产品和负责团队核对。", "en": "On 2024-01-19, after completing its review, FDA added a Boxed Warning to U.S. Prolia (denosumab) prescribing information about severe hypocalcemia risk in patients with advanced chronic kidney disease; the communication specifically discusses dialysis patients and people with CKD-mineral and bone disorder. This is U.S. regulatory information for a named product and population. It cannot determine whether any person is in that population, needs testing or monitoring, or should start, defer, stop or change a product. Check the current target-market label, actual product and responsible care team." }, "source": { "id": "src_7d3704e2d032f4ee", "label": "FDA：2024-01-19 Prolia（地舒单抗）晚期慢性肾病患者严重低钙血症黑框警告药物安全通讯", "url": "https://www.fda.gov/drugs/drug-safety-communications/fda-adds-boxed-warning-increased-risk-severe-hypocalcemia-patients-advanced-chronic-kidney-disease", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "FDA 的 PROLIA（denosumab）2025 美国标签列示其为皮下注射用制剂，并列出美国初始批准年份为 2010。页面仅提供美国公开监管资料阅读入口；不据此推定其他市场的当前批准、规格、持有人、原研关系、供应或可售资格。", "history": "骨代谢相关注射产品需要同时核对商品名、通用名、规格、注射途径、目标市场和现行标签。单一包装、历史文件或“补钙/骨质”文字不能建立个人适用性、开始/停用或与其他产品的替代关系。", "sourceDocuments": [ { "id": "src_5bf3f2f89ac96a4c", "label": "FDA：PROLIA 2025-05 美国标签（BLA 125320）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/125320s219lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_9fe61a483b99938c", "label": "DailyMed（NLM）：PROLIA 公开标签（2026-06 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=49e5afe9-a0c7-40c4-af9f-f287a80c5c88", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_5ed30b676fbb9773", "label": "FDA Drugs@FDA 官方检索入口", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_lookup_entry", "documentKind": "regulatory_lookup", "market": "US", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } ], "applicationNumber": "BLA 125320", "approvalTimeline": [ { "date": "2010", "title": { "zh": "FDA 标签所列美国初始批准年份", "en": "Initial U.S. approval year listed in the FDA label" }, "detail": { "zh": "本页链接的 FDA 标签档案列示 Initial U.S. Approval: 2010。该历史定位不等同于当前批准、可得性、持有人或其他市场状态。", "en": "The FDA label archive linked here lists Initial U.S. Approval: 2010. This historical locator is not a conclusion about current approval, availability, holder or another market." }, "source": { "id": "src_5bf3f2f89ac96a4c", "label": "FDA: PROLIA prescribing information", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/125320s219lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, { "date": "2025-05", "title": { "zh": "FDA 标签档案版本", "en": "FDA label archive version" }, "detail": { "zh": "本页链接 2025-05 的 FDA 标签档案作为可复核阅读入口。现行标签、规格、适应症和安全信息必须另行以目标市场当前文件核对。", "en": "This page links the 2025-05 FDA label archive as a traceable reading entry point. Current labeling, strength, indication and safety information require separate verification against the target market’s current document." }, "source": { "id": "src_5bf3f2f89ac96a4c", "label": "FDA: PROLIA prescribing information", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/125320s219lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "已链接公开标签档案", "en": "Public label archive linked" }, "detail": { "zh": "仅对应本页所列 FDA 文件。", "en": "Only the FDA document listed on this page is linked." } }, { "market": { "zh": "中国大陆、欧盟、日本", "en": "Mainland China, EU, Japan" }, "status": { "zh": "待逐项建立市场记录", "en": "Market record not established" }, "detail": { "zh": "不从美国标签档案推定当地批准、持有人、规格、供应或可售资格。", "en": "No local approval, holder, strength, supply or sale-eligibility conclusion is inferred from the U.S. label archive." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "标签档案能代表现在的产品信息吗？", "en": "Does a label archive represent current product information?" }, "answer": { "zh": "不能自动代表。档案用于定位来源；需要以目标市场的现行官方标签逐项复核。", "en": "Not automatically. The archive locates a source; each point needs verification against the target market’s current official label." } }, { "question": { "zh": "为什么这里不展示价格或原研/仿制结论？", "en": "Why are price and originator/generic conclusions not shown?" }, "answer": { "zh": "这些结论需要产品、剂型、规格、包装、市场、日期和原始记录分别齐全并经人工审核；单一标签文件不足以支持。", "en": "Those conclusions require separately complete and human-reviewed product, dosage-form, strength, pack, market, date and primary-record fields; one label file is insufficient." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "dosage-forms-are-part-of-medicine-identity", "medicine-label-for-everyday-questions", "how-to-read-a-drug-label" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/prolia/", "en": "https://origindrug.com/en/drugs/prolia/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "fosamax", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-23", "status": "published_traceable_archive" }, "names": { "brand": "Fosamax", "generic": "阿仑膦酸钠", "aliases": [ "alendronate", "alendronate sodium" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "骨骼健康", "sourceArchiveMarket": "美国当前公开处方药标签（DailyMed SPL v10，2026-03-12 生效；不代表供应）", "dosageFormClass": "口服片剂及口服溶液（当前美国公开标签所列；本页精确包装卡仅为 70 mg、4 片单元用量泡罩包装）", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "1995（DailyMed 当前美国公开标签所列 Initial U.S. Approval）", "archiveSponsorText": "Organon LLC / DailyMed（NLM）当前公开标签" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-fosamax-alendronate-sodium-tablet-70mg-4-blister-ndc-78206-135-01", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v10（2026-03-12 生效）", "en": "DailyMed SPL v10 (effective 12 Mar 2026)" }, "dosageForm": { "zh": "FOSAMAX 阿仑膦酸钠口服片", "en": "FOSAMAX alendronate sodium oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 78206-135-01", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片阿仑膦酸钠 70 mg；4 片单元用量泡罩包装", "en": "Alendronate sodium 70 mg per tablet; unit-of-use blister pack of 4" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=14e931fd-2c5f-4d90-b7db-5980706f4a56&type=img&name=fosamax-08.jpg", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "阿仑膦酸钠", "en": "alendronate sodium" }, "value": 70, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签量；不是个人片数、频率或漏用处理", "en": "labelled amount per tablet; not an individual's tablet count, frequency or missed-use action" } } ], "concentration": null, "container": { "typeCode": "unit_of_use_blister_pack", "typeLabel": { "zh": "单元用量泡罩包装", "en": "unit-of-use blister package" }, "fill": null, "countPerPackage": 4, "countUnit": { "zh": "片/泡罩包装", "en": "tablets per blister package" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": null, "package": { "count": 4, "unit": { "zh": "片/单元用量泡罩包装", "en": "tablets per unit-of-use blister package" } }, "physicalClues": { "color": { "zh": "白色", "en": "white" }, "shape": { "zh": "椭圆形未包衣片", "en": "oval uncoated tablet" }, "imprint": "31 / bone outline", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_e067de6121693865", "label": "DailyMed（NLM）：FOSAMAX 阿仑膦酸钠当前美国公开标签（Organon；SPL v10，2026-03-12 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=14e931fd-2c5f-4d90-b7db-5980706f4a56", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-fosamax-alendronate-sodium-tablet-70mg-4-blister-ndc-78206-135-01", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=14e931fd-2c5f-4d90-b7db-5980706f4a56&type=img&name=fosamax-08.jpg", "alt": "FOSAMAX 阿仑膦酸钠在美国 DailyMed 当前公开标签中的 70 mg、NDC 78206-135-01、4 片单元用量泡罩包装展示面", "archiveMarket": "美国", "labelVersion": "DailyMed SPL v10（2026-03-12 生效）", "presentation": "FOSAMAX 阿仑膦酸钠：每片 70 mg，NDC 78206-135-01，4 片单元用量泡罩包装展示面。", "notice": "此图只对应美国 DailyMed 当前公开标签中的 FOSAMAX、阿仑膦酸钠 70 mg、NDC 78206-135-01 与 4 片单元用量泡罩包装。它只帮助核对品牌、通用名、每片标示量、剂型、包装数量、外观线索和来源；不用于鉴定真伪，也不证明其他强度、口服溶液、其他包装、其他市场、当前可得性、原研身份、可替代性，或任何个人的片数、频率、漏用处理、开始、停用或换药方案。", "source": { "id": "src_e067de6121693865", "label": "DailyMed（NLM）：FOSAMAX 阿仑膦酸钠当前美国公开标签（Organon；SPL v10，2026-03-12 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=14e931fd-2c5f-4d90-b7db-5980706f4a56", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "FOSAMAX 说明书放大阅读：70 mg、4 片包装先是这一个产品的身份", "en": "FOSAMAX label reading: 70 mg and four tablets first identify this one product presentation" }, "summary": { "zh": "本模块以美国 DailyMed 当前公开标签为阅读入口，帮助核对 FOSAMAX、阿仑膦酸钠、70 mg 口服片、NDC 78206-135-01、4 片单元用量泡罩包装与目标市场。它不把这些标签文字转换为个人治疗、片数、频率、漏用处理、分片或换药方案。", "en": "This module uses the current U.S. DailyMed public label to check FOSAMAX, alendronate sodium, a 70 mg oral tablet, NDC 78206-135-01, the four-tablet unit-of-use blister pack and target market. It does not turn label wording into an individual's treatment, tablet-count, frequency, missed-use, splitting or switching plan." }, "checks": [ { "zh": "先把商品名 FOSAMAX、通用名阿仑膦酸钠、口服片、每片 70 mg、NDC 78206-135-01、4 片单元用量泡罩包装与目标市场一起核对。70 mg 与“4 片”是这一张官方标签卡的身份字段，不是网页给任何人计算片数、频率或疗程的答案。", "en": "Check FOSAMAX, alendronate sodium, oral-tablet form, 70 mg per tablet, NDC 78206-135-01, the four-tablet unit-of-use blister pack and target market together. 70 mg and “four tablets” are identity fields for this official label card, not a web answer to anyone's tablet count, frequency or course." }, { "zh": "当前标签还提及口服溶液，但本档案没有为它建立精确包装卡。共同品牌或通用名不使片剂、口服溶液、其他强度或另一市场的产品可按片数、毫升数或经验自行换算、替换或叠加。", "en": "The current label also mentions oral solution, but this dossier does not establish an exact package card for it. A shared brand or generic name does not make tablets, oral solution, other strengths or another-market products self-convertible, substitutable or combinable by tablet count, millilitres or experience." }, { "zh": "该美国标签对吞服、饮水、进食/其他药物间隔和保持直立有产品特定要求。若吞咽困难、无法按标签姿势操作，或正在同时使用多种药物，应先请药师或开方团队核对，不要从网页自行改用、掰开或改时间。", "en": "This U.S. label has product-specific instructions about swallowing, water, spacing from food/other medicines and remaining upright. With swallowing difficulty, inability to follow those positioning instructions, or multiple medicines, ask a pharmacist or prescriber before self-switching, splitting or changing timing from a webpage." }, { "zh": "出现吞咽或胸部不适、明显胃肠道症状、牙科/手术计划或其他新的健康问题时，带上实际包装和完整药单联系专业人员；本页不判断是否应继续、暂停或更换。", "en": "With swallowing or chest discomfort, significant gastrointestinal symptoms, a dental/procedure plan or another new health issue, bring the actual pack and complete medicine list to a professional; this page does not decide whether to continue, pause or change." } ], "source": { "id": "src_e067de6121693865", "label": "DailyMed（NLM）：FOSAMAX 阿仑膦酸钠当前美国公开标签（Organon；SPL v10，2026-03-12 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=14e931fd-2c5f-4d90-b7db-5980706f4a56", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "阿仑膦酸钠怎样起作用：它在骨吸收部位影响破骨细胞活动", "en": "How alendronate works: it affects osteoclast activity at sites of bone resorption" }, "summary": { "zh": "DailyMed 当前公开标签说明阿仑膦酸钠会与骨的羟基磷灰石结合，并在骨吸收部位抑制破骨细胞活动和骨吸收。骨吸收与骨形成相互关联；这段机制不能推断个人骨折风险、检查结果或继续、暂停与更换治疗的决定。", "en": "The current DailyMed public label explains that alendronate binds bone hydroxyapatite and inhibits osteoclast activity and bone resorption at resorption sites. Bone resorption and bone formation are linked; this mechanism cannot infer an individual's fracture risk, test result or a decision to continue, pause or change treatment." }, "checks": [ { "zh": "“影响破骨细胞”描述的是骨重塑中的一条路径，不是个人骨密度、骨折风险或治疗效果的网页结论。检查结果和治疗选择需要由专业人员结合完整情况解释。", "en": "“Affecting osteoclasts” describes one pathway in bone remodelling; it is not a webpage conclusion about an individual's bone density, fracture risk or treatment response. Test results and treatment choices need professional interpretation in full context." }, { "zh": "共同机制不使 70 mg 片、口服溶液、其他强度或另一市场产品可自行互换。强度、剂型、频率和现行处方必须作为完整产品信息分别核对。", "en": "A shared mechanism does not make the 70 mg tablet, oral solution, another strength or another-market product self-interchangeable. Strength, dosage form, frequency and the current prescription must be checked as complete product information." }, { "zh": "吞服姿势、饮水、空腹及与其他药物的间隔是标签和实际产品层面的要求，不能由机制反推。吞咽困难、无法按标签操作或需调整任何药物时，请先请药师或开方团队核对。", "en": "Swallowing position, water, fasting and spacing from other medicines are requirements of the label and actual product; they cannot be inferred from mechanism. With swallowing difficulty, inability to follow the label or a need to adjust any medicine, ask a pharmacist or prescriber first." } ], "source": { "id": "src_e067de6121693865", "label": "DailyMed（NLM）：FOSAMAX 阿仑膦酸钠当前美国公开标签（临床药理；SPL v10，2026-03-12 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=14e931fd-2c5f-4d90-b7db-5980706f4a56", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "Fosamax", "generic": "阿仑膦酸钠", "dosageFormClass": "口服片剂及口服溶液（当前美国公开标签所列；本页精确包装卡仅为 70 mg、4 片单元用量泡罩包装）" }, "labelSource": { "id": "src_e067de6121693865", "label": "DailyMed（NLM）：FOSAMAX 阿仑膦酸钠当前美国公开标签（Organon；SPL v10，2026-03-12 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=14e931fd-2c5f-4d90-b7db-5980706f4a56", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "productRoutes": [ { "source": { "id": "src_e067de6121693865", "label": "DailyMed（NLM）：FOSAMAX 阿仑膦酸钠当前美国公开标签（Organon；SPL v10，2026-03-12 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=14e931fd-2c5f-4d90-b7db-5980706f4a56", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "DailyMed 的当前 FOSAMAX（alendronate sodium）美国公开标签列示口服片剂与口服溶液，并标注美国初始批准年份为 1995。本页只展示已逐项核对的 70 mg、4 片单元用量泡罩包装身份；它不据此推定其他强度、口服溶液、其他市场的当前批准、包装、供应、原研关系或可售资格。", "history": "骨骼健康相关药品也必须将品牌、通用名、剂型、标示强度、目标市场和标签版本一起核对。即使同为 FOSAMAX 或阿仑膦酸钠，70 mg 泡罩包装的资料也不能代替其他强度、口服溶液或另一市场产品的现行标签。", "sourceDocuments": [ { "id": "src_e067de6121693865", "label": "DailyMed（NLM）：FOSAMAX 阿仑膦酸钠当前美国公开标签（Organon；SPL v10，2026-03-12 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=14e931fd-2c5f-4d90-b7db-5980706f4a56", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_5ed30b676fbb9773", "label": "FDA Drugs@FDA 官方检索入口", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_lookup_entry", "documentKind": "regulatory_lookup", "market": "US", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } ], "applicationNumber": "NDA 020560", "approvalTimeline": [ { "date": "1995", "title": { "zh": "美国初始批准年份", "en": "Initial U.S. approval year" }, "detail": { "zh": "DailyMed 当前 FOSAMAX 公开标签列示 Initial U.S. Approval: 1995。该年份不代表当前包装、供应、持有人、其他市场状态或个人适用性。", "en": "The current DailyMed FOSAMAX public label lists Initial U.S. Approval: 1995. This year does not establish the current package, supply, holder, another-market status or individual suitability." }, "source": { "id": "src_e067de6121693865", "label": "DailyMed（NLM）：FOSAMAX 阿仑膦酸钠当前美国公开标签（Organon；SPL v10，2026-03-12 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=14e931fd-2c5f-4d90-b7db-5980706f4a56", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, { "date": "2026-03-12", "title": { "zh": "当前美国公开标签生效", "en": "Current U.S. public label effective" }, "detail": { "zh": "DailyMed 产品页列示 FOSAMAX SPL v10 的生效日期为 2026-03-12。本页的精确包装图仅对应同一来源中 70 mg、NDC 78206-135-01 的 4 片单元用量泡罩包装。", "en": "The DailyMed product page lists an effective date of 12 Mar 2026 for FOSAMAX SPL v10. The exact package image on this page corresponds only to the same source's 70 mg, NDC 78206-135-01, four-tablet unit-of-use blister pack." }, "source": { "id": "src_e067de6121693865", "label": "DailyMed（NLM）：FOSAMAX 阿仑膦酸钠当前美国公开标签（Organon；SPL v10，2026-03-12 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=14e931fd-2c5f-4d90-b7db-5980706f4a56", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "已链接当前公开标签与一个精确 70 mg、4 片泡罩包装面板", "en": "Current public label and one exact 70 mg four-tablet blister panel linked" }, "detail": { "zh": "该图只对应 NDC 78206-135-01；不建立其他强度、口服溶液、其他包装、实际供应或其他市场结论。", "en": "The image corresponds only to NDC 78206-135-01; it does not establish another strength, oral solution, another package, actual supply or another-market status." } }, { "market": { "zh": "其他市场", "en": "Other markets" }, "status": { "zh": "待逐项建立市场记录", "en": "Market record not established" }, "detail": { "zh": "不从美国当前标签推定其他市场的商品名、批准、包装、供应、原研关系或可替代性。", "en": "No other-market trade name, approval, package, supply, originator relationship or interchangeability is inferred from the current U.S. label." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "70 mg 与 4 片包装是什么意思？", "en": "What do 70 mg and a four-tablet pack mean?" }, "answer": { "zh": "它们是这张准确美国包装标签的身份信息：每片标示量与包装内片数。网页不会把它们转成任何人的服用频率、片数、漏用处理、分片或换药方案；请以实际包装、现行处方和药师/开方团队的复核为准。", "en": "They are identity information for this exact U.S. package label: the stated amount per tablet and tablet count in the pack. This site does not turn them into anyone's frequency, tablet count, missed-use action, splitting or switching plan; use the actual package, current prescription and pharmacist/prescriber review." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/fosamax/", "en": "https://origindrug.com/en/drugs/fosamax/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "actonel", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-20", "status": "published_traceable_archive" }, "names": { "brand": "Actonel", "generic": "利塞膦酸钠", "aliases": [ "risedronate", "risedronate sodium" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "骨骼健康", "sourceArchiveMarket": "美国公开处方药标签档案（DailyMed 2026-02 版本）", "dosageFormClass": "口服薄膜衣片（不同标示强度与适用情形须按准确标签逐项核对）", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "1998（DailyMed 公开标签所列美国初始批准）", "archiveSponsorText": "Allergan, Inc. / DailyMed（NLM）公开标签档案" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-actonel-tablet-35mg-ndc-0430-0472-03", "marketCode": "US", "labelVersion": { "zh": "DailyMed 公开标签（2026-02 修订）", "en": "DailyMed public label (revised February 2026)" }, "dosageForm": { "zh": "利塞膦酸钠口服薄膜衣片", "en": "risedronate sodium oral film-coated tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 0430-0472-03", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片 35 mg；4 片装", "en": "35 mg per tablet; 4-tablet pack" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=actonel-0a.jpg&setid=24ed00e0-25e2-49a8-97fc-66c1b417dc0b&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "利塞膦酸钠", "en": "risedronate sodium" }, "value": 35, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标示量", "en": "labelled amount per tablet" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": null, "package": { "count": 4, "unit": { "zh": "片/包装", "en": "tablets per pack" } }, "physicalClues": { "color": { "zh": "橙色", "en": "orange" }, "shape": { "zh": "椭圆形薄膜衣片", "en": "oval film-coated tablet" }, "imprint": "RSN / 35 mg", "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_437d6305e1e7ec01", "label": "DailyMed（NLM）：ACTONEL 35 mg、4 片装（NDC 0430-0472-03；2026-02 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=24ed00e0-25e2-49a8-97fc-66c1b417dc0b", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-actonel-tablet-150mg-ndc-0430-0478-01", "marketCode": "US", "labelVersion": { "zh": "DailyMed 公开标签（2026-02 修订）", "en": "DailyMed public label (revised February 2026)" }, "dosageForm": { "zh": "利塞膦酸钠口服薄膜衣片", "en": "risedronate sodium oral film-coated tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 0430-0478-01", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片 150 mg；1 片装", "en": "150 mg per tablet; 1-tablet pack" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=actonel-0c.jpg&setid=24ed00e0-25e2-49a8-97fc-66c1b417dc0b&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "利塞膦酸钠", "en": "risedronate sodium" }, "value": 150, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标示量", "en": "labelled amount per tablet" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": null, "package": { "count": 1, "unit": { "zh": "片/包装", "en": "tablet per pack" } }, "physicalClues": { "color": { "zh": "蓝色", "en": "blue" }, "shape": { "zh": "椭圆形薄膜衣片", "en": "oval film-coated tablet" }, "imprint": "RSN / 150 mg", "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_437d6305e1e7ec01", "label": "DailyMed（NLM）：ACTONEL 150 mg、1 片装（NDC 0430-0478-01；2026-02 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=24ed00e0-25e2-49a8-97fc-66c1b417dc0b", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": null, "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=actonel-0a.jpg&setid=24ed00e0-25e2-49a8-97fc-66c1b417dc0b&type=img", "alt": "ACTONEL 35 mg 利塞膦酸钠片在美国 DailyMed 公开标签中的 4 片装主展示图", "archiveMarket": "美国", "labelVersion": "DailyMed 公开标签（Allergan，2026-02 修订）", "presentation": "ACTONEL 利塞膦酸钠 35 mg、NDC 0430-0472-03、4 片装主展示图（DailyMed 公开标签所列）。", "notice": "此为美国 DailyMed 公开标签中明确对应 ACTONEL、利塞膦酸钠 35 mg、NDC 0430-0472-03、4 片装的 Allergan 主展示图，只帮助核对品牌、通用名、标示强度、片剂、包装数量和来源；不用于鉴定真伪，也不证明 5 mg、30 mg、75 mg、150 mg、其他包装、其他市场标签、当前可得性、原研身份、目标市场批准或可售资格。", "source": { "id": "src_437d6305e1e7ec01", "label": "DailyMed（NLM）：ACTONEL 利塞膦酸钠公开标签（Allergan，2026-02 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=24ed00e0-25e2-49a8-97fc-66c1b417dc0b", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "ACTONEL 说明书放大阅读：片剂强度与不同用药文字，先用于确认准确产品", "en": "ACTONEL label reading: tablet strength and different label wording first identify the exact product" }, "summary": { "zh": "本模块以美国 DailyMed 2026-02 公开标签为阅读入口，帮助核对 ACTONEL、利塞膦酸钠、口服薄膜衣片、标示强度与标签中的产品特定操作文字。它不把这些信息变成任何人的片数、时间表、联用、转换或停药建议。", "en": "This module uses the Feb 2026 U.S. DailyMed public label to check ACTONEL, risedronate sodium, oral film-coated tablets, labelled strength and product-specific administration wording. It does not turn those details into an individual's tablet count, schedule, combination, switching or stopping advice." }, "checks": [ { "zh": "先把 ACTONEL、利塞膦酸钠、准确口服片剂、每片标示强度、实际包装和目标市场一起核对。包装上的 mg 是该片的身份字段，不是网页可以换算成个人每天/每周应服几片的答案。", "en": "Check ACTONEL, risedronate sodium, the exact oral tablet, stated strength per tablet, actual package and target market together. Milligrams on the package identify that tablet; they are not a web answer for how many tablets a person should take on a day or in a week." }, { "zh": "标签将不同适用情形、片剂强度和产品特定操作要求分开呈现。名称相同、骨骼健康用途相近、包装数字相近，均不表示可以自行叠加、隔天轮换、掰开、换规格或与另一种双膦酸盐产品替代。", "en": "The label separates different use contexts, tablet strengths and product-specific handling requirements. A shared name, related bone-health wording or similar package numbers do not make products self-combinable, alternate-day interchangeable, splittable, strength-convertible or substitutable with another bisphosphonate." }, { "zh": "该标签对上消化道问题、低钙、颌骨相关风险、非典型骨折和肾功能等列有警示。出现吞咽或胸部不适、明显新疼痛、牙科/手术计划或其他担忧时，应带实际药盒和完整药单联系药师或开方团队；网页不判断是否自行继续、暂停或替换。", "en": "The label includes warnings involving upper gastrointestinal problems, low calcium, jaw-related risk, atypical fractures and kidney function. With swallowing or chest discomfort, substantial new pain, a dental/procedure plan or another concern, bring the actual pack and complete medicine list to a pharmacist or prescribing team; this page does not decide self-continuation, pause or replacement." }, { "zh": "同服的钙、维生素、矿物质补充剂、抗酸产品、处方药和非处方药都应在完整药单中逐项核对。不要把“骨质疏松药”“补钙”或“胃药”等类别文字理解成可以自行同服、错开、补用或调整的规则。", "en": "Calcium, vitamin or mineral supplements, antacid products, prescriptions and OTC medicines used alongside it all need item-by-item review in a complete medicine list. Do not turn category words such as ‘bone medicine’, ‘calcium’ or ‘stomach medicine’ into a self-directed rule for co-use, spacing, make-up use or adjustment." } ], "source": { "id": "src_f24813e51e48e2a1", "label": "DailyMed（NLM）：ACTONEL 利塞膦酸钠公开标签（Allergan，2026-02 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=24ed00e0-25e2-49a8-97fc-66c1b417dc0b", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "利塞膦酸钠怎样起作用：标签将其归为双膦酸盐，作用于骨重塑相关路径", "en": "How risedronate works: the label classifies it as a bisphosphonate acting in a bone-remodelling pathway" }, "summary": { "zh": "DailyMed 标签将 ACTONEL 描述为双膦酸盐，并说明其对骨有亲和力、可在骨吸收部位抑制破骨细胞活动。这个机制帮助理解为何准确产品、骨骼情况、肾功能、牙科计划和完整药单都需要一起核对；它不预测个人骨密度、骨折风险、适用性、片数或治疗时长。", "en": "The DailyMed label describes ACTONEL as a bisphosphonate with affinity for bone that inhibits osteoclast activity at sites of bone resorption. This helps explain why the exact product, bone context, kidney function, dental plan and complete medicine list need review together; it does not predict an individual's bone density, fracture risk, suitability, tablet count or treatment duration." }, "checks": [ { "zh": "“影响破骨细胞”解释的是骨重塑中的一条药理路径，不能从网页判断某个人是否患有骨质疏松、骨折风险有多高、检查结果意味着什么，或是否应开始、继续、暂停或换药。", "en": "‘Affects osteoclasts’ explains one pharmacologic pathway in bone remodelling. It cannot determine from a webpage whether a person has osteoporosis, their fracture risk, what a test result means, or whether treatment should start, continue, pause or change." }, { "zh": "与另一种双膦酸盐或骨骼健康产品机制相近，不表示可以自行同日叠加、轮换、替代，或用相近 mg 数字进行换算。每个产品的剂型、强度、标签、既往反应和完整药单都必须分别核对。", "en": "A related mechanism with another bisphosphonate or bone-health product does not permit self-combination on the same day, alternation, substitution or conversion from similar milligram numbers. Each product's dosage form, strength, label, prior reactions and complete medicine list must be reviewed separately." }, { "zh": "机制页面不能处理吞咽困难、胃肠道症状、低钙担忧、牙科/手术安排或任何急性不适。出现此类问题时，应依据手上准确产品的现行标签并联系当地药师、开方团队或紧急医疗支持，而不是自行改变方案。", "en": "A mechanism page cannot manage swallowing difficulty, gastrointestinal symptoms, a low-calcium concern, a dental/procedure plan or any acute problem. With such an issue, use the current label for the exact product and contact local pharmacy, prescribing-team or urgent medical support rather than self-changing a regimen." } ], "source": { "id": "src_f24813e51e48e2a1", "label": "DailyMed（NLM）：ACTONEL 利塞膦酸钠公开标签（Clinical Pharmacology，2026-02 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=24ed00e0-25e2-49a8-97fc-66c1b417dc0b", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "Actonel", "generic": "利塞膦酸钠", "dosageFormClass": "口服薄膜衣片（不同标示强度与适用情形须按准确标签逐项核对）" }, "labelSource": { "id": "src_f24813e51e48e2a1", "label": "DailyMed（NLM）：ACTONEL 利塞膦酸钠公开标签（Allergan，2026-02 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=24ed00e0-25e2-49a8-97fc-66c1b417dc0b", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "productRoutes": [ { "source": { "id": "src_f24813e51e48e2a1", "label": "DailyMed（NLM）：ACTONEL 利塞膦酸钠公开标签（Allergan，2026-02 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=24ed00e0-25e2-49a8-97fc-66c1b417dc0b", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "DailyMed 的 ACTONEL（risedronate sodium）美国公开标签将其列为口服薄膜衣片，并列出美国初始批准年份为 1998。页面帮助读者把品牌、通用名、准确片剂、标示强度、包装与目标市场一起核对；不据此生成个人片数、给药时点、联用、转换或停药方案。", "history": "ACTONEL 的美国公开标签在 2026-02 修订，并保留标签档案版本。此处建立的是该具体美国品牌标签的可回溯阅读入口；不推定中国大陆或其他市场的当前批准、持有人、包装、供应、可售资格或原研/仿制关系。", "sourceDocuments": [ { "id": "src_f24813e51e48e2a1", "label": "DailyMed（NLM）：ACTONEL 利塞膦酸钠公开标签（Allergan，2026-02 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=24ed00e0-25e2-49a8-97fc-66c1b417dc0b", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_5ed30b676fbb9773", "label": "FDA Drugs@FDA 官方检索入口", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_lookup_entry", "documentKind": "regulatory_lookup", "market": "US", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } ], "applicationNumber": "NDA 020835（DailyMed 公开标签所列美国市场标识）", "approvalTimeline": [ { "date": "1998", "title": { "zh": "FDA 标签所列美国初始批准年份", "en": "Initial U.S. approval year listed in the FDA label" }, "detail": { "zh": "本页链接的 FDA 标签档案列示 Initial U.S. Approval: 1998。该历史定位不等同于当前批准、可得性、持有人或其他市场状态。", "en": "The FDA label archive linked here lists Initial U.S. Approval: 1998. This historical locator is not a conclusion about current approval, availability, holder or another market." }, "source": { "id": "src_f24813e51e48e2a1", "label": "DailyMed: ACTONEL public label", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=24ed00e0-25e2-49a8-97fc-66c1b417dc0b", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, { "date": "2026-02", "title": { "zh": "FDA 标签档案版本", "en": "FDA label archive version" }, "detail": { "zh": "本页链接 2026-02 的 FDA 标签档案作为可复核阅读入口。现行标签、规格、适应症和安全信息必须另行以目标市场当前文件核对。", "en": "This page links the 2026-02 FDA label archive as a traceable reading entry point. Current labeling, strength, indication and safety information require separate verification against the target market’s current document." }, "source": { "id": "src_f24813e51e48e2a1", "label": "DailyMed: ACTONEL public label", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=24ed00e0-25e2-49a8-97fc-66c1b417dc0b", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "已链接公开标签档案", "en": "Public label archive linked" }, "detail": { "zh": "仅对应本页所列 FDA 文件。", "en": "Only the FDA document listed on this page is linked." } }, { "market": { "zh": "中国大陆、欧盟、日本", "en": "Mainland China, EU, Japan" }, "status": { "zh": "待逐项建立市场记录", "en": "Market record not established" }, "detail": { "zh": "不从美国标签档案推定当地批准、持有人、规格、供应或可售资格。", "en": "No local approval, holder, strength, supply or sale-eligibility conclusion is inferred from the U.S. label archive." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "标签档案能代表现在的产品信息吗？", "en": "Does a label archive represent current product information?" }, "answer": { "zh": "不能自动代表。档案用于定位来源；需要以目标市场的现行官方标签逐项复核。", "en": "Not automatically. The archive locates a source; each point needs verification against the target market’s current official label." } }, { "question": { "zh": "为什么这里不展示价格或原研/仿制结论？", "en": "Why are price and originator/generic conclusions not shown?" }, "answer": { "zh": "这些结论需要产品、剂型、规格、包装、市场、日期和原始记录分别齐全并经人工审核；单一标签文件不足以支持。", "en": "Those conclusions require separately complete and human-reviewed product, dosage-form, strength, pack, market, date and primary-record fields; one label file is insufficient." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "how-to-read-a-drug-label", "regulatory-sources-first" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/actonel/", "en": "https://origindrug.com/en/drugs/actonel/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "boniva", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-25", "status": "published_traceable_archive" }, "names": { "brand": "Boniva", "generic": "伊班膦酸钠", "aliases": [ "ibandronate", "ibandronate sodium" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "骨骼健康", "sourceArchiveMarket": "美国公开处方药历史标签档案（FDA 2015）；本页另以同一文件的 150 mg 片剂文字身份线索（白色、长圆形、BNVA／150 刻印）辅助核对，不推定当前包装、可得性或其他市场状态", "dosageFormClass": "口服薄膜衣片：历史标签列有 2.5 mg 与 150 mg 片剂；本页仅建立 150 mg 片的文字身份卡（须按准确标签逐项核对）", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "2003（FDA 2015 标签所列美国初始批准）", "archiveSponsorText": "Genentech / FDA 与 DailyMed 历史公开标签档案" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-boniva-ibandronate-150mg-tablet-bnva-150-historical-2015", "marketCode": "US", "labelVersion": { "zh": "FDA 美国历史标签（2015-04 修订；不是当前标签）", "en": "FDA U.S. historical label (revised Apr 2015; not current)" }, "dosageForm": { "zh": "BONIVA 伊班膦酸钠口服薄膜衣片", "en": "BONIVA ibandronate sodium film-coated oral tablet" }, "route": { "zh": "口服（历史标签产品身份字段）", "en": "oral (historical-label product-identity field)" }, "routeCodes": [ "oral" ], "productCode": null, "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片 150 mg（美国历史标签文字身份）", "en": "150 mg per tablet (U.S. historical-label text identity)" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "伊班膦酸钠", "en": "ibandronate sodium" }, "value": 150, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片历史标签量；不是个人片数或日历", "en": "historical labelled amount per tablet; not an individual tablet count or calendar" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": null, "package": null, "physicalClues": { "color": { "zh": "白色", "en": "white" }, "shape": { "zh": "长圆形片", "en": "oblong tablet" }, "imprint": "BNVA / 150", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_6f34a135ec0d44b9", "label": "FDA：BONIVA 2015 美国处方信息（剂型与强度；NDA 021455）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021455s020lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "status": "withheld_repackaged_or_non_exact_visual", "title": { "zh": "已核验到历史标签中的再包装信息，故不展示为原品牌包装", "en": "A historical label with repackaging information was reviewed, so it is not shown as an original-brand package" }, "summary": { "zh": "DailyMed 可检索到的 BONIVA 历史标签列示 Physicians Total Care, Inc. 的再包装信息。它可帮助追溯品牌、通用名与历史文件，却不能被当作本页准确原品牌包装图；为避免视觉误导，本档案保留图片空位并链接原始标签。", "en": "The searchable historical DailyMed BONIVA label lists repackaging information for Physicians Total Care, Inc. It helps trace the brand, generic name and historical document, but cannot be presented as this record's exact original-brand pack; to avoid a misleading visual, this dossier leaves the image space withheld and links the primary label." }, "source": { "id": "src_28d8acec5946ced8", "label": "DailyMed（NLM）：BONIVA 伊班膦酸钠历史公开标签（含再包装信息）", "url": "https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=d6d7711f-541b-47d1-b937-2c6a021eb6c3", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "BONIVA 说明书放大阅读：2.5 mg、150 mg 与实际药盒必须一起核对", "en": "BONIVA label reading: 2.5 mg, 150 mg and the actual pack must be checked together" }, "summary": { "zh": "本模块以 FDA 2015 美国 BONIVA 历史标签为阅读入口，帮助核对 BONIVA、伊班膦酸钠、口服薄膜衣片、每片标示强度与标签中的产品特定操作文字。它不把这些信息变成任何人的片数、日历、联用、转换或停药建议。", "en": "This module uses the 2015 U.S. FDA BONIVA historical label to check BONIVA, ibandronate sodium, oral film-coated tablets, stated strength per tablet and product-specific handling language. It does not turn these details into an individual's tablet count, calendar, combination, switching or stopping advice." }, "checks": [ { "zh": "先把 BONIVA、伊班膦酸钠、准确口服片剂、每片标示强度、实际包装和目标市场一起核对。2.5 mg、150 mg 是历史标签的产品身份字段，不是网页可以换算成个人应服几片、哪天服用或漏用后怎样补的答案。", "en": "Check BONIVA, ibandronate sodium, the exact oral tablet, stated strength per tablet, actual pack and target market together. The historical 2.5 mg and 150 mg entries identify products; they are not a web answer for an individual's tablet count, calendar or what to do after a missed use." }, { "zh": "相同骨骼健康用途、相似包装数字或同属双膦酸盐，不表示可以自行与阿仑膦酸盐、利塞膦酸盐或其他骨骼健康产品叠加、轮换、替代、掰开或换规格。每一个准确产品都要按现行标签、既往反应和完整药单单独复核。", "en": "A shared bone-health use, similar package numbers or bisphosphonate class does not permit self-combining, alternating, replacing, splitting or strength-changing with alendronate, risedronate or another bone-health product. Each exact product needs separate review against its current label, prior reactions and the complete medicine list." }, { "zh": "历史标签涉及钙、抗酸产品、维生素与其他口服产品的核对事项。不要从类别名推导自行错开、补用或停止；把全部处方药、非处方药、补充剂、草本和实际药盒交给药师或开方团队逐项核对。", "en": "The historical label includes review considerations involving calcium, antacid products, vitamins and other oral products. Do not derive a self-directed spacing, make-up or stopping rule from category names; have a pharmacist or prescribing team review every prescription, OTC product, supplement, herb and actual pack item by item." }, { "zh": "标签对吞咽或胸部不适、低钙、颌骨相关风险、非典型骨折、肾功能与牙科/手术计划列有需要专业复核的信息。出现急性不适或需要处理牙科/手术安排时，应及时使用当地医疗渠道，而不是依据网页自行继续、暂停或替换。", "en": "The label includes information needing professional review for swallowing or chest symptoms, low calcium, jaw-related risk, atypical fractures, kidney function and dental/procedure plans. With an acute concern or a dental/procedure arrangement, use local medical pathways promptly rather than self-continuing, pausing or replacing a product from a webpage." } ], "source": { "id": "src_6f34a135ec0d44b9", "label": "FDA：BONIVA 2015 美国处方信息（NDA 021455）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021455s020lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "伊班膦酸钠怎样起作用：历史标签将其归为抑制骨吸收的双膦酸盐", "en": "How ibandronate works: the historical label classifies it as a bisphosphonate that inhibits bone resorption" }, "summary": { "zh": "FDA 历史标签将 BONIVA 描述为含氮双膦酸盐，并说明其抑制破骨细胞介导的骨吸收。这个机制帮助理解为何准确产品、骨骼情况、肾功能、牙科计划和完整药单都需要一起核对；它不预测个人骨密度、骨折风险、适用性、片数或治疗时长。", "en": "The FDA historical label describes BONIVA as a nitrogen-containing bisphosphonate that inhibits osteoclast-mediated bone resorption. This helps explain why the exact product, bone context, kidney function, dental plan and complete medicine list need review together; it does not predict an individual's bone density, fracture risk, suitability, tablet count or treatment duration." }, "checks": [ { "zh": "“抑制骨吸收”解释的是骨重塑中的一条药理路径，不能从网页判断某个人是否有骨质疏松、骨折风险有多高、检查结果意味着什么，或是否应开始、继续、暂停或更换产品。", "en": "‘Inhibits bone resorption’ explains one pharmacologic pathway in bone remodelling. It cannot determine from a webpage whether a person has osteoporosis, their fracture risk, what a test result means, or whether a product should start, continue, pause or change." }, { "zh": "与另一种双膦酸盐或骨骼健康产品机制相近，不表示可以自行同日叠加、轮换、替代，或用相近 mg 数字进行换算。每个产品的剂型、强度、标签、既往反应和完整药单都必须分别核对。", "en": "A related mechanism with another bisphosphonate or bone-health product does not permit self-combination on the same day, alternation, substitution or conversion from similar milligram numbers. Each product's dosage form, strength, label, prior reactions and complete medicine list must be reviewed separately." }, { "zh": "机制页面不能处理吞咽困难、胸部不适、胃肠道症状、低钙担忧、牙科/手术安排或任何急性不适。出现此类问题时，应依据手上准确产品的现行标签并联系当地药师、开方团队或紧急医疗支持。", "en": "A mechanism page cannot manage swallowing difficulty, chest symptoms, gastrointestinal symptoms, a low-calcium concern, a dental/procedure plan or any acute problem. With such an issue, use the current label for the exact product and contact local pharmacy, the prescribing team or urgent medical support." } ], "source": { "id": "src_6f34a135ec0d44b9", "label": "FDA：BONIVA 2015 美国处方信息（Clinical Pharmacology）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021455s020lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "Boniva", "generic": "伊班膦酸钠", "dosageFormClass": "口服薄膜衣片：历史标签列有 2.5 mg 与 150 mg 片剂；本页仅建立 150 mg 片的文字身份卡（须按准确标签逐项核对）" }, "labelSource": { "id": "src_6f34a135ec0d44b9", "label": "FDA：BONIVA 2015 美国处方信息（NDA 021455）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021455s020lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "productRoutes": [ { "source": { "id": "src_6f34a135ec0d44b9", "label": "FDA：BONIVA 2015 美国处方信息（NDA 021455）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021455s020lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_28d8acec5946ced8", "label": "DailyMed（NLM）：BONIVA 伊班膦酸钠历史公开标签", "url": "https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=d6d7711f-541b-47d1-b937-2c6a021eb6c3", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "FDA 的 BONIVA（ibandronate sodium）2015 美国历史标签将其列为口服薄膜衣片，并列出美国初始批准年份为 2003。本页把品牌、通用名、每片 150 mg、白色长圆形、BNVA／150 刻印与美国历史文件放在一起核对；它不根据这些身份线索生成个人片数、日期、联用、转换、停药或骨骼健康治疗方案。", "history": "本页保留的是 BONIVA 美国历史标签的可回溯阅读入口。150 mg 的白色长圆形、BNVA／150 刻印来自该文件的剂型与强度描述；它是历史文字身份线索，不是当前包装图、真伪鉴定、当前持有人、其他市场批准、供应、可售资格或原研/仿制关系的证明。DailyMed 可检索到的相关历史标签包含再包装方信息，故不展示为原品牌包装图。", "sourceDocuments": [ { "id": "src_6f34a135ec0d44b9", "label": "FDA：BONIVA 2015 美国处方信息（NDA 021455）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021455s020lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_28d8acec5946ced8", "label": "DailyMed（NLM）：BONIVA 伊班膦酸钠历史公开标签", "url": "https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=d6d7711f-541b-47d1-b937-2c6a021eb6c3", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_5ed30b676fbb9773", "label": "FDA Drugs@FDA 官方检索入口", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_lookup_entry", "documentKind": "regulatory_lookup", "market": "US", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } ], "applicationNumber": "NDA 021455", "approvalTimeline": [ { "date": "2003", "title": { "zh": "FDA 标签所列美国初始批准年份", "en": "Initial U.S. approval year listed in the FDA label" }, "detail": { "zh": "本页链接的 FDA 标签档案列示 Initial U.S. Approval: 2003。该历史定位不等同于当前批准、可得性、持有人或其他市场状态。", "en": "The FDA label archive linked here lists Initial U.S. Approval: 2003. This historical locator is not a conclusion about current approval, availability, holder or another market." }, "source": { "id": "src_6f34a135ec0d44b9", "label": "FDA: BONIVA historical label archive", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021455s020lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, { "date": "2015", "title": { "zh": "FDA 标签档案版本", "en": "FDA label archive version" }, "detail": { "zh": "本页链接 2015 的 FDA 标签档案作为可复核阅读入口。现行标签、规格、适应症和安全信息必须另行以目标市场当前文件核对。", "en": "This page links the 2015 FDA label archive as a traceable reading entry point. Current labeling, strength, indication and safety information require separate verification against the target market’s current document." }, "source": { "id": "src_6f34a135ec0d44b9", "label": "FDA: BONIVA historical label archive", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021455s020lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "已链接公开标签档案", "en": "Public label archive linked" }, "detail": { "zh": "仅对应本页所列 FDA 文件。", "en": "Only the FDA document listed on this page is linked." } }, { "market": { "zh": "中国大陆、欧盟、日本", "en": "Mainland China, EU, Japan" }, "status": { "zh": "待逐项建立市场记录", "en": "Market record not established" }, "detail": { "zh": "不从美国标签档案推定当地批准、持有人、规格、供应或可售资格。", "en": "No local approval, holder, strength, supply or sale-eligibility conclusion is inferred from the U.S. label archive." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "标签档案能代表现在的产品信息吗？", "en": "Does a label archive represent current product information?" }, "answer": { "zh": "不能自动代表。档案用于定位来源；需要以目标市场的现行官方标签逐项复核。", "en": "Not automatically. The archive locates a source; each point needs verification against the target market’s current official label." } }, { "question": { "zh": "为什么这里不展示价格或原研/仿制结论？", "en": "Why are price and originator/generic conclusions not shown?" }, "answer": { "zh": "这些结论需要产品、剂型、规格、包装、市场、日期和原始记录分别齐全并经人工审核；单一标签文件不足以支持。", "en": "Those conclusions require separately complete and human-reviewed product, dosage-form, strength, pack, market, date and primary-record fields; one label file is insufficient." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "how-to-read-a-drug-label", "regulatory-sources-first" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/boniva/", "en": "https://origindrug.com/en/drugs/boniva/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "aricept", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-20", "status": "published_traceable_archive" }, "names": { "brand": "Aricept", "generic": "多奈哌齐", "aliases": [ "donepezil", "donepezil hydrochloride", "ARICEPT", "Aricept", "多奈哌齐", "盐酸多奈哌齐", "盐酸多奈哌齐片", "多奈哌齐片", "安理申" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": { "value": "安理申®", "status": "discovery_cue_requires_target_market_verification", "source": { "id": "src_b714bd77500b54db", "label": "诸暨市人民政府：2025 年医院药品目录中的安理申／多奈哌齐片 5 mg×7 片记录", "url": "https://www.zhuji.gov.cn/art/2025/1/2/art_1453401_59147560.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "government_medicine_listing", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-13", "reviewedAt": "2026-09-13" } } }, "identity": { "therapeuticArea": "神经与认知", "sourceArchiveMarket": "美国当前公开处方药标签（DailyMed SPL v33，2026-06-30 发布）", "dosageFormClass": "口服薄膜衣片：5 mg、10 mg、23 mg；口腔崩解片：5 mg、10 mg（当前美国标签所列）", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "1996（当前美国标签所列 Initial U.S. Approval）", "archiveSponsorText": "Eisai Inc. / DailyMed（NLM）当前公开标签" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-aricept-tablet-5mg-ndc-62856-245-30", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v33，2026-06-30 发布", "en": "DailyMed SPL v33, published 30 Jun 2026" }, "dosageForm": { "zh": "ARICEPT 多奈哌齐盐酸盐薄膜衣口服片", "en": "ARICEPT donepezil hydrochloride film-coated oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 62856-245-30", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "5 mg；30 片瓶装", "en": "5 mg; 30-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=98e451e1-e4d7-4439-a675-c5457ba20975&type=img&name=aricept-0f.jpg", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "多奈哌齐盐酸盐", "en": "donepezil hydrochloride" }, "value": 5, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标示量", "en": "labelled amount per tablet" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "30 片瓶装", "en": "30-tablet bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": null, "package": { "count": 30, "unit": { "zh": "30 片瓶装", "en": "30-tablet bottle" } }, "physicalClues": { "color": { "zh": "白色", "en": "white" }, "shape": { "zh": "圆片", "en": "round tablet" }, "imprint": "ARICEPT / 5", "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_7876f620d1fff474", "label": "DailyMed（NLM）：ARICEPT / ARICEPT ODT 当前美国公开标签（Eisai；SPL v33，2026-06-30 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=98e451e1-e4d7-4439-a675-c5457ba20975", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-aricept-tablet-10mg-ndc-62856-246-30", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v33，2026-06-30 发布", "en": "DailyMed SPL v33, published 30 Jun 2026" }, "dosageForm": { "zh": "ARICEPT 多奈哌齐盐酸盐薄膜衣口服片", "en": "ARICEPT donepezil hydrochloride film-coated oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 62856-246-30", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "10 mg；30 片瓶装", "en": "10 mg; 30-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=98e451e1-e4d7-4439-a675-c5457ba20975&type=img&name=aricept-10.jpg", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "多奈哌齐盐酸盐", "en": "donepezil hydrochloride" }, "value": 10, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标示量", "en": "labelled amount per tablet" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "30 片瓶装", "en": "30-tablet bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": null, "package": { "count": 30, "unit": { "zh": "30 片瓶装", "en": "30-tablet bottle" } }, "physicalClues": { "color": { "zh": "黄色", "en": "yellow" }, "shape": { "zh": "圆片", "en": "round tablet" }, "imprint": "ARICEPT / 10", "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_7876f620d1fff474", "label": "DailyMed（NLM）：ARICEPT / ARICEPT ODT 当前美国公开标签（Eisai；SPL v33，2026-06-30 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=98e451e1-e4d7-4439-a675-c5457ba20975", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-aricept-tablet-23mg-ndc-62856-247-30", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v33，2026-06-30 发布", "en": "DailyMed SPL v33, published 30 Jun 2026" }, "dosageForm": { "zh": "ARICEPT 多奈哌齐盐酸盐薄膜衣口服片", "en": "ARICEPT donepezil hydrochloride film-coated oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 62856-247-30", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "23 mg；30 片瓶装", "en": "23 mg; 30-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=98e451e1-e4d7-4439-a675-c5457ba20975&type=img&name=aricept-11.jpg", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "多奈哌齐盐酸盐", "en": "donepezil hydrochloride" }, "value": 23, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标示量", "en": "labelled amount per tablet" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "30 片瓶装", "en": "30-tablet bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": null, "package": { "count": 30, "unit": { "zh": "30 片瓶装", "en": "30-tablet bottle" } }, "physicalClues": { "color": { "zh": "红色", "en": "reddish" }, "shape": { "zh": "圆片", "en": "round tablet" }, "imprint": "ARICEPT / 23", "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_7876f620d1fff474", "label": "DailyMed（NLM）：ARICEPT / ARICEPT ODT 当前美国公开标签（Eisai；SPL v33，2026-06-30 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=98e451e1-e4d7-4439-a675-c5457ba20975", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-aricept-odt-5mg-ndc-62856-831-30", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v33，2026-06-30 发布", "en": "DailyMed SPL v33, published 30 Jun 2026" }, "dosageForm": { "zh": "ARICEPT ODT 多奈哌齐盐酸盐口腔崩解片", "en": "ARICEPT ODT donepezil hydrochloride orally disintegrating tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 62856-831-30", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "5 mg；30 片单位剂量泡罩盒（10×3）", "en": "5 mg; 30-tablet unit-dose blister carton (10 × 3)" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=98e451e1-e4d7-4439-a675-c5457ba20975&type=img&name=aricept-12.jpg", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "多奈哌齐盐酸盐", "en": "donepezil hydrochloride" }, "value": 5, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标示量", "en": "labelled amount per tablet" } } ], "concentration": null, "container": { "typeCode": "unit_dose_blister", "typeLabel": { "zh": "单位剂量泡罩盒", "en": "unit-dose blister carton" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "30 片单位剂量泡罩盒（10×3）", "en": "30-tablet unit-dose blister carton (10 × 3)" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": null, "package": { "count": 30, "unit": { "zh": "30 片单位剂量泡罩盒（10×3）", "en": "30-tablet unit-dose blister carton (10 × 3)" } }, "physicalClues": { "color": { "zh": "白色", "en": "white" }, "shape": { "zh": "圆片", "en": "round tablet" }, "imprint": "ARICEPT / 5", "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_7876f620d1fff474", "label": "DailyMed（NLM）：ARICEPT / ARICEPT ODT 当前美国公开标签（Eisai；SPL v33，2026-06-30 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=98e451e1-e4d7-4439-a675-c5457ba20975", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-aricept-odt-10mg-ndc-62856-832-30", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v33，2026-06-30 发布", "en": "DailyMed SPL v33, published 30 Jun 2026" }, "dosageForm": { "zh": "ARICEPT ODT 多奈哌齐盐酸盐口腔崩解片", "en": "ARICEPT ODT donepezil hydrochloride orally disintegrating tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 62856-832-30", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "10 mg；30 片单位剂量泡罩盒（10×3）", "en": "10 mg; 30-tablet unit-dose blister carton (10 × 3)" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=98e451e1-e4d7-4439-a675-c5457ba20975&type=img&name=aricept-13.jpg", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "多奈哌齐盐酸盐", "en": "donepezil hydrochloride" }, "value": 10, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标示量", "en": "labelled amount per tablet" } } ], "concentration": null, "container": { "typeCode": "unit_dose_blister", "typeLabel": { "zh": "单位剂量泡罩盒", "en": "unit-dose blister carton" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "30 片单位剂量泡罩盒（10×3）", "en": "30-tablet unit-dose blister carton (10 × 3)" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": null, "package": { "count": 30, "unit": { "zh": "30 片单位剂量泡罩盒（10×3）", "en": "30-tablet unit-dose blister carton (10 × 3)" } }, "physicalClues": { "color": { "zh": "黄色", "en": "yellow" }, "shape": { "zh": "圆片", "en": "round tablet" }, "imprint": "ARICEPT / 10", "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_7876f620d1fff474", "label": "DailyMed（NLM）：ARICEPT / ARICEPT ODT 当前美国公开标签（Eisai；SPL v33，2026-06-30 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=98e451e1-e4d7-4439-a675-c5457ba20975", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-aricept-tablet-5mg-ndc-62856-245-30", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=98e451e1-e4d7-4439-a675-c5457ba20975&type=img&name=aricept-0f.jpg", "alt": "ARICEPT 多奈哌齐盐酸盐 5 mg、NDC 62856-245-30、30 片瓶装的美国 DailyMed 当前标签包装面板", "archiveMarket": "美国", "labelVersion": "DailyMed SPL v33（2026-06-30 发布）", "presentation": "ARICEPT 多奈哌齐盐酸盐 5 mg 薄膜衣口服片、NDC 62856-245-30、30 片瓶装包装面板（当前美国标签所列）。", "notice": "此图只对应 ARICEPT、薄膜衣口服片、5 mg、NDC 62856-245-30 与 30 片瓶装；不用于鉴定真伪，也不代表 10 mg、23 mg、ARICEPT ODT、其他包装、其他市场、当前可得性或任何个人用药方案。", "source": { "id": "src_7876f620d1fff474", "label": "DailyMed（NLM）：ARICEPT / ARICEPT ODT 当前美国公开标签（Eisai；SPL v33，2026-06-30 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=98e451e1-e4d7-4439-a675-c5457ba20975", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "ARICEPT 说明书放大阅读：普通片、口腔崩解片与 23 mg 必须一起核对", "en": "ARICEPT label reading: tablets, ODT and 23 mg must be checked together" }, "summary": { "zh": "本模块以 Eisai 的当前美国 DailyMed 标签为阅读入口，帮助核对 ARICEPT 的普通片、口腔崩解片、每片标示量、NDC 与包装；它不提供个人开始、加量、停用、转换或拆分方案。", "en": "This module uses Eisai's current U.S. DailyMed label as a reading entry point. It helps check ARICEPT tablets, orally disintegrating tablets, labelled amount per tablet, NDC and package; it does not provide an individual start, increase, stop, switch or splitting plan." }, "checks": [ { "zh": "先核对 ARICEPT、通用名多奈哌齐、普通片或口腔崩解片、每片标示强度和目标市场。一个“5”“10”或“23”数字不能单独说明应如何服用，也不能证明与另一种包装可互换。", "en": "First check ARICEPT, donepezil, tablet or orally disintegrating tablet, labelled strength per unit and target market. A “5”, “10” or “23” alone does not say how a person should use it or prove interchangeability with another pack." }, { "zh": "当前美国标签区分 5、10、23 mg 普通片和 5、10 mg 口腔崩解片；其中 23 mg 普通片的标签写明不应掰开、压碎或咀嚼。不同市场或产品版本须回到该准确产品的现行标签复核。", "en": "The current U.S. label distinguishes 5, 10 and 23 mg tablets and 5 and 10 mg orally disintegrating tablets; it states that the 23 mg tablet should not be split, crushed or chewed. Another market or product version needs checking against the current label for that exact product." }, { "zh": "标签列出可能需要关注的心率、胃肠道、体重、麻醉及与抗胆碱能或其他胆碱能药物的联用问题。家中同时有多种记忆、睡眠、感冒、止痛或膀胱相关药物时，应带完整药单请药师复核，不要自行叠加、替代或停用。", "en": "The label identifies issues that may require attention involving heart rate, gastrointestinal effects, weight, anaesthesia and combinations with anticholinergic or other cholinergic medicines. When multiple memory, sleep, cold, pain or bladder products are at home, bring the complete list to a pharmacist rather than self-combining, substituting or stopping." }, { "zh": "出现昏厥、明显心率异常、持续呕吐/脱水、黑便或其他急性不适，应寻求及时医疗评估；网页和历史标签不能替代紧急判断。", "en": "For fainting, a marked heart-rate concern, persistent vomiting/dehydration, black stools or another acute symptom, seek timely medical assessment; a webpage and historical label cannot replace urgent judgement." } ], "source": { "id": "src_7876f620d1fff474", "label": "DailyMed（NLM）：ARICEPT / ARICEPT ODT 当前美国公开标签（Eisai；SPL v33，2026-06-30 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=98e451e1-e4d7-4439-a675-c5457ba20975", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "多奈哌齐怎样起作用：它可逆性抑制乙酰胆碱酯酶", "en": "How donepezil works: it reversibly inhibits acetylcholinesterase" }, "summary": { "zh": "FDA 标签将多奈哌齐描述为可逆性乙酰胆碱酯酶抑制剂，并说明其主要药理作用是抑制乙酰胆碱水解。该机制帮助理解它为何与其他影响胆碱能系统的产品需要一起核对；它不预测个人记忆变化，也不决定个人强度、加减量、停用或与其他认知相关药物的转换。", "en": "The FDA label describes donepezil as a reversible acetylcholinesterase inhibitor and states that its main pharmacologic action is inhibition of acetylcholine hydrolysis. This helps explain why products affecting the cholinergic system need review together; it does not predict an individual's memory change or decide individual strength, adjustment, discontinuation or conversion with another cognition-related medicine." }, "checks": [ { "zh": "共同影响胆碱能系统，不表示多奈哌齐与其他记忆药、膀胱药、抗过敏/感冒药或保健品可自行叠加、抵消、替代或轮换。所有处方药、非处方药和补充剂都应带给药师或开方团队逐项核对。", "en": "A shared effect on the cholinergic system does not make donepezil self-combinable, cancellable, substitutable or alternatable with another memory medicine, bladder medicine, allergy/cold product or supplement. Every prescription, OTC product and supplement should be reviewed item by item with a pharmacist or prescribing team." }, { "zh": "机制不能把 5、10、23 mg 或普通片/口腔崩解片转换为个人的服用规则，也不能说明某个数字“更适合”某人。具体剂型、强度、既往情况、其他用药与现行标签必须一并核对。", "en": "Mechanism cannot convert 5, 10 or 23 mg, or tablet/ODT form, into an individual's use rule, nor show that one number “suits” someone better. Exact form, strength, prior circumstances, other medicines and the current label must be checked together." }, { "zh": "心率变化、昏厥、胃肠道不适、体重变化或新的行为/意识问题都不能从机制页面自行处理。出现急性症状或考虑改变任何认知相关药物时，应及时使用当地专业支持。", "en": "Heart-rate changes, fainting, gastrointestinal symptoms, weight change or a new behaviour/awareness concern cannot be self-managed from a mechanism page. With an acute symptom or a plan to change any cognition-related medicine, use timely local professional support." } ], "source": { "id": "src_7876f620d1fff474", "label": "DailyMed（NLM）：ARICEPT / ARICEPT ODT 当前美国公开标签（Clinical Pharmacology；Eisai；SPL v33）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=98e451e1-e4d7-4439-a675-c5457ba20975", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "Aricept", "generic": "多奈哌齐", "dosageFormClass": "口服薄膜衣片：5 mg、10 mg、23 mg；口腔崩解片：5 mg、10 mg（当前美国标签所列）" }, "labelSource": { "id": "src_7876f620d1fff474", "label": "DailyMed（NLM）：ARICEPT / ARICEPT ODT 当前美国公开标签（Eisai；SPL v33，2026-06-30 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=98e451e1-e4d7-4439-a675-c5457ba20975", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "productRoutes": [ { "source": { "id": "src_7876f620d1fff474", "label": "DailyMed（NLM）：ARICEPT / ARICEPT ODT 当前美国公开标签（Eisai；SPL v33，2026-06-30 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=98e451e1-e4d7-4439-a675-c5457ba20975", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "DailyMed 的当前 ARICEPT / ARICEPT ODT 美国公开标签列示多奈哌齐盐酸盐的普通口服片与口腔崩解片。页面帮助把完整品牌名、准确剂型、每片标示量、NDC、包装与目标市场一起核对；不据此生成个人开始、加量、停用、转换或购买方案。", "history": "相同通用名或相近数字，不能把普通片、口腔崩解片、不同强度或其他认知相关药物变成可自行互换的产品。认知相关药物及家中其他处方药、非处方药和补充剂，应连同完整用药清单一起由药师或开方团队核对。", "sourceDocuments": [ { "id": "src_7876f620d1fff474", "label": "DailyMed（NLM）：ARICEPT / ARICEPT ODT 当前美国公开标签（Eisai；SPL v33，2026-06-30 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=98e451e1-e4d7-4439-a675-c5457ba20975", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_5ed30b676fbb9773", "label": "FDA Drugs@FDA 官方检索入口", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_lookup_entry", "documentKind": "regulatory_lookup", "market": "US", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } ], "applicationNumber": "NDA 020690 / 022568（当前美国标签所列品牌标签体系）", "approvalTimeline": [ { "date": "1996", "title": { "zh": "当前标签所列美国初始批准年份", "en": "Initial U.S. approval year listed in the current label" }, "detail": { "zh": "当前 ARICEPT / ARICEPT ODT 标签列示 Initial U.S. Approval: 1996；该年份不自动说明其他市场状态。", "en": "The current ARICEPT / ARICEPT ODT label lists Initial U.S. Approval: 1996; it does not establish status in another market." }, "source": { "id": "src_7876f620d1fff474", "label": "DailyMed（NLM）：ARICEPT / ARICEPT ODT 当前美国公开标签（Eisai；SPL v33，2026-06-30 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=98e451e1-e4d7-4439-a675-c5457ba20975", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, { "date": "2026-06-30", "title": { "zh": "DailyMed 当前 SPL v33 公开", "en": "Current SPL v33 published on DailyMed" }, "detail": { "zh": "DailyMed 的媒体目录列示 ARICEPT / ARICEPT ODT 当前 SPL v33 于 2026-06-30 发布，并含本页列示的 5 个精确包装面板。该日期和图片不证明实际在售、库存或其他包装/市场状态。", "en": "DailyMed's media listing shows current ARICEPT / ARICEPT ODT SPL v33 published on 30 Jun 2026 and includes the five exact package panels shown here. The date and images do not establish actual marketing, stock or another package/market status." }, "source": { "id": "src_7876f620d1fff474", "label": "DailyMed（NLM）：ARICEPT / ARICEPT ODT 当前美国公开标签（Eisai；SPL v33，2026-06-30 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=98e451e1-e4d7-4439-a675-c5457ba20975", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "已链接当前标签与 5 个精确包装面板", "en": "Current label and five exact package panels linked" }, "detail": { "zh": "展示面板分别对应 5 mg、10 mg、23 mg 普通片以及 5 mg、10 mg ARICEPT ODT 的特定 NDC；不据此建立实际在售、库存、个人服用或其他包装状态。", "en": "The display panels correspond separately to the specified NDCs for 5 mg, 10 mg and 23 mg tablets and 5 mg and 10 mg ARICEPT ODT; they do not establish actual marketing, stock, individual use or another-package status." } }, { "market": { "zh": "中国大陆、欧盟、日本及其他市场", "en": "Mainland China, EU, Japan and other markets" }, "status": { "zh": "待逐项建立市场记录", "en": "Market record not established" }, "detail": { "zh": "不从美国标签推定当地商品名、批准、包装、供应、原研关系或可替代性。", "en": "No local trade name, approval, package, supply, originator relationship or interchangeability is inferred from the U.S. label." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "ARICEPT 与 ARICEPT ODT 能否只看同样的毫克数就自行互换？", "en": "Can ARICEPT and ARICEPT ODT be self-switched just because the milligrams match?" }, "answer": { "zh": "不能。普通片与口腔崩解片是不同的准确产品形态；相同通用名或相同数字不足以建立自行互换、掰开、压碎、咀嚼或调整方案。请把实际包装、NDC 与完整药单交给药师或开方团队核对。", "en": "No. Tablets and orally disintegrating tablets are different exact product forms. A shared generic name or number does not establish self-switching, splitting, crushing, chewing or adjustment. Have a pharmacist or prescribing team check the actual package, NDC and complete medicine list." } }, { "question": { "zh": "23 mg 是不是可以由较低强度的片剂自行拼出来？", "en": "Can 23 mg be self-assembled from lower-strength tablets?" }, "answer": { "zh": "不能。本页仅展示标签身份；当前美国标签将 23 mg 普通片单列，并写明不应掰开、压碎或咀嚼。网页不把包装数字转换为个人片数或转换方案。", "en": "No. This page shows label identity only. The current U.S. label lists the 23 mg tablet separately and says it should not be split, crushed or chewed. This page does not convert package numbers into a personal tablet count or switching plan." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "dosage-forms-are-part-of-medicine-identity", "how-to-read-a-drug-label" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/aricept/", "en": "https://origindrug.com/en/drugs/aricept/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "sinemet", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-09-05", "status": "published_traceable_archive" }, "names": { "brand": "Sinemet", "generic": "卡比多巴/左旋多巴（复方）", "aliases": [ "SINEMET", "carbidopa and levodopa", "carbidopa/levodopa", "卡比多巴 左旋多巴" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "神经与认知", "sourceArchiveMarket": "美国当前公开处方药标签（2026-07 修订；DailyMed v6 于 2026-08-24 发布）及同页保留的有结束日期 NDC 记录", "dosageFormClass": "当前供应段列出即释口服复方片 10 mg/100 mg 与 25 mg/100 mg；25 mg/250 mg 已不再营销", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "1975（FDA 公开审评资料支持的批准年份；精确日期在后续文件中存在单处冲突）", "archiveSponsorText": "Organon LLC / DailyMed（NLM）当前公开标签与结构化 NDC 档案" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-sinemet-10-100-ndc-78206-166-01", "marketCode": "US", "labelVersion": { "zh": "2026-03-19", "en": "2026-03-19" }, "dosageForm": { "zh": "即释口服片", "en": "immediate-release oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 78206-166-01", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片：卡比多巴 10 mg + 左旋多巴 100 mg；当前结构化记录无营销结束日期", "en": "Per tablet: carbidopa 10 mg + levodopa 100 mg; no marketing end date in the current structured record" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=9b17b028-964a-473c-823d-81423535bd66&type=img&name=sinemet-03.jpg", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "卡比多巴", "en": "carbidopa" }, "value": 10, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片含量", "en": "amount per tablet" } }, { "ingredient": { "zh": "左旋多巴", "en": "levodopa" }, "value": 100, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片含量", "en": "amount per tablet" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-05", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "current_regulatory_listing_not_live_stock", "marketingStartDate": "2021-06-01", "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "深斑蓝色", "en": "dark dapple blue" }, "shape": { "zh": "椭圆片", "en": "oval tablet" }, "imprint": "647", "scoreStatus": "scored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_8ea7dd73b92efe4f", "label": "DailyMed（NLM）：SINEMET 卡比多巴/左旋多巴当前美国公开标签与结构化 NDC 数据（Organon；2026-07 修订；2026-08-24 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=9b17b028-964a-473c-823d-81423535bd66", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-05", "reviewedAt": "2026-09-05" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-sinemet-25-100-ndc-78206-190-01", "marketCode": "US", "labelVersion": { "zh": "2026-03-19", "en": "2026-03-19" }, "dosageForm": { "zh": "即释口服片", "en": "immediate-release oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 78206-190-01", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片：卡比多巴 25 mg + 左旋多巴 100 mg；当前结构化记录无营销结束日期", "en": "Per tablet: carbidopa 25 mg + levodopa 100 mg; no marketing end date in the current structured record" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=9b17b028-964a-473c-823d-81423535bd66&type=img&name=sinemet-06.jpg", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "卡比多巴", "en": "carbidopa" }, "value": 25, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片含量", "en": "amount per tablet" } }, { "ingredient": { "zh": "左旋多巴", "en": "levodopa" }, "value": 100, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片含量", "en": "amount per tablet" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-05", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "current_regulatory_listing_not_live_stock", "marketingStartDate": "2025-02-28", "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "黄色", "en": "yellow" }, "shape": { "zh": "椭圆片", "en": "oval tablet" }, "imprint": "650", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_8ea7dd73b92efe4f", "label": "DailyMed（NLM）：SINEMET 卡比多巴/左旋多巴当前美国公开标签与结构化 NDC 数据（Organon；2026-07 修订；2026-08-24 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=9b17b028-964a-473c-823d-81423535bd66", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-05", "reviewedAt": "2026-09-05" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-sinemet-25-100-ndc-78206-168-01", "marketCode": "US", "labelVersion": { "zh": "2026-03-19", "en": "2026-03-19" }, "dosageForm": { "zh": "即释口服片", "en": "immediate-release oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 78206-168-01", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片：卡比多巴 25 mg + 左旋多巴 100 mg；营销记录结束于 2026-02-21", "en": "Per tablet: carbidopa 25 mg + levodopa 100 mg; marketing record ended 2026-02-21" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=9b17b028-964a-473c-823d-81423535bd66&type=img&name=sinemet-04.jpg", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "卡比多巴", "en": "carbidopa" }, "value": 25, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片含量", "en": "amount per tablet" } }, { "ingredient": { "zh": "左旋多巴", "en": "levodopa" }, "value": 100, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片含量", "en": "amount per tablet" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-05", "currentLabelDisplayed": false, "ndcDirectoryListed": true, "marketAvailability": "dated_ndc_record_marketing_ended_not_live_stock", "marketingStartDate": "2021-06-01", "marketingEndDate": "2026-02-21", "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "黄色", "en": "yellow" }, "shape": { "zh": "椭圆片", "en": "oval tablet" }, "imprint": "650", "scoreStatus": "scored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_8ea7dd73b92efe4f", "label": "DailyMed（NLM）：SINEMET 卡比多巴/左旋多巴当前美国公开标签与结构化 NDC 数据（Organon；2026-07 修订；2026-08-24 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=9b17b028-964a-473c-823d-81423535bd66", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-05", "reviewedAt": "2026-09-05" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-sinemet-25-250-ndc-78206-167-01", "marketCode": "US", "labelVersion": { "zh": "2026-03-19", "en": "2026-03-19" }, "dosageForm": { "zh": "即释口服片", "en": "immediate-release oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 78206-167-01", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片：卡比多巴 25 mg + 左旋多巴 250 mg；营销记录结束于 2021-06-02", "en": "Per tablet: carbidopa 25 mg + levodopa 250 mg; marketing record ended 2021-06-02" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=9b17b028-964a-473c-823d-81423535bd66&type=img&name=sinemet-05.jpg", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "卡比多巴", "en": "carbidopa" }, "value": 25, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片含量", "en": "amount per tablet" } }, { "ingredient": { "zh": "左旋多巴", "en": "levodopa" }, "value": 250, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片含量", "en": "amount per tablet" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-05", "currentLabelDisplayed": false, "ndcDirectoryListed": true, "marketAvailability": "dated_ndc_record_marketing_ended_not_live_stock", "marketingStartDate": "2021-06-01", "marketingEndDate": "2021-06-02", "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "浅斑蓝色", "en": "light dapple blue" }, "shape": { "zh": "椭圆片", "en": "oval tablet" }, "imprint": "654", "scoreStatus": "scored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_8ea7dd73b92efe4f", "label": "DailyMed（NLM）：SINEMET 卡比多巴/左旋多巴当前美国公开标签与结构化 NDC 数据（Organon；2026-07 修订；2026-08-24 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=9b17b028-964a-473c-823d-81423535bd66", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-05", "reviewedAt": "2026-09-05" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-sinemet-25-100-ndc-78206-190-01", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=9b17b028-964a-473c-823d-81423535bd66&type=img&name=sinemet-06.jpg", "alt": "SINEMET 卡比多巴/左旋多巴在美国 DailyMed Organon 当前公开标签中的 25 mg/100 mg、NDC 78206-190-01、无刻痕、100 片装标签图", "archiveMarket": "美国", "labelVersion": "DailyMed 当前公开标签（Organon；2026-07 修订；2026-08-24 发布）", "presentation": "SINEMET 每片卡比多巴 25 mg / 左旋多巴 100 mg，NDC 78206-190-01，无刻痕，100 片瓶装标签图", "notice": "此图只对应当前 HOW SUPPLIED 所列的 NDC 78206-190-01（25 mg/100 mg、无刻痕、100 片）。同页保留的 NDC 78206-168-01 有刻痕旧面板，但其结构化营销记录已于 2026-02-21 结束；本图不代表该历史包装、其他强度、其他市场或实时库存，不用于鉴定真伪，也不证明原研身份、可替代性或任何个人能否分片。", "source": { "id": "src_8ea7dd73b92efe4f", "label": "DailyMed（NLM）：SINEMET 当前美国公开标签（Organon；2026-07 修订；2026-08-24 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=9b17b028-964a-473c-823d-81423535bd66", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-05", "reviewedAt": "2026-09-05" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "SINEMET 说明书放大阅读：25/100 是两种成分的每片含量，不是片数", "en": "SINEMET label reading: 25/100 is a per-tablet two-ingredient identity, not a tablet count" }, "summary": { "zh": "本模块以 2026-07 修订、2026-08-24 发布的美国当前公开标签为阅读入口，帮助核对 SINEMET、卡比多巴/左旋多巴、即释片、每片两种成分、NDC、刻痕、当前供应段与带结束日期的历史记录。它不提供个人片数、时间表、漏用补救、餐食/铁剂间隔、联用、转换或停药方案。", "en": "This module uses the current U.S. label revised Jul 2026 and published 24 Aug 2026 to check SINEMET, carbidopa/levodopa, immediate-release tablets, both ingredients per tablet, NDC, score state, the current How Supplied section and dated historical records. It does not provide an individual tablet count, schedule, missed-use remedy, food/iron interval, combination, switch or stopping plan." }, "checks": [ { "zh": "“10/100”“25/100”“25/250”分别表示每片卡比多巴与左旋多巴的标示量；不能把两个数相加当成总强度，更不能从包装数字推导今天应服几片。", "en": "“10/100”, “25/100” and “25/250” state carbidopa and levodopa amounts in each tablet. Do not add the two numbers into one total strength or derive today's tablet count from package numbers." }, { "zh": "同为 25 mg/100 mg，也要继续核对 NDC、刻痕和日期：当前 HOW SUPPLIED 列 NDC 78206-190-01（无刻痕）；NDC 78206-168-01（有刻痕）的结构化营销记录已于 2026-02-21 结束。相同品牌和强度不能掩盖当前/历史差别，更不能替网页回答能否分片。", "en": "The same 25 mg / 100 mg strength still requires the NDC, score state and date: the current How Supplied section lists NDC 78206-190-01 (unscored), while the structured marketing record for NDC 78206-168-01 (scored) ended 21 Feb 2026. Matching brand and strength cannot erase the current-versus-historical distinction or let a webpage decide splitting." }, { "zh": "本档案是即释片。Sinemet CR、Rytary、Crexont、Dhivy、Duopa、Vyalev 或其他卡比多巴/左旋多巴制剂并非本页同一产品呈现；不能按成分名或毫克比自行替换、叠加或轮换。", "en": "This archive concerns immediate-release tablets. Sinemet CR, Rytary, Crexont, Dhivy, Duopa, Vyalev and other carbidopa/levodopa products are not this same presentation; do not self-substitute, combine or alternate them by ingredient name or milligram ratio." }, { "zh": "标签提示高蛋白饮食变化、铁盐或含铁复合维生素等可能影响左旋多巴的可利用度。页面只提示把饮食变化、补充剂和完整药单交给药师或处方医生核对，不生成个人餐时或间隔。", "en": "The label notes that dietary changes high in protein and iron salts or iron-containing multivitamins may affect levodopa availability. This page only prompts review of diet changes, supplements and the complete medicine list with a pharmacist or prescriber; it does not generate personal meal timing or spacing." }, { "zh": "老年人并不是自动减半。当前标签报告老年人左旋多巴暴露可能增加，并指出不能排除部分老人对幻觉等不良反应更敏感；跌倒、嗜睡、体位性低血压、认知或行为变化都应结合准确处方、完整药单和照护观察由专业团队复核。", "en": "Older age does not mean automatically taking half. The current label reports that levodopa exposure may be higher in older adults and that greater sensitivity to adverse reactions such as hallucinations cannot be ruled out. Falls, somnolence, orthostatic effects, and cognitive or behavioural changes need professional review using the exact prescription, complete medicine list and caregiver observations." }, { "zh": "不要自行补服、加倍、骤减、骤停或增加其他抗帕金森药。突然入睡、昏厥、严重意识/行为变化、发热伴明显僵硬或惊厥等急性担忧，应及时使用当地紧急医疗支持。", "en": "Do not self-make-up, double, abruptly reduce or stop, or add another antiparkinson medicine. Sudden sleep, fainting, severe mental/behavioural change, fever with marked rigidity or a seizure warrants prompt local urgent medical support." } ], "source": { "id": "src_8ea7dd73b92efe4f", "label": "DailyMed（NLM）：SINEMET 当前美国公开标签（Organon；2026-07 修订；2026-08-24 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=9b17b028-964a-473c-823d-81423535bd66", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-05", "reviewedAt": "2026-09-05" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "卡比多巴/左旋多巴怎样起作用：一个进入脑内，一个主要在外周减少分解", "en": "How carbidopa/levodopa works: one reaches the brain while the other mainly reduces peripheral breakdown" }, "summary": { "zh": "DailyMed 标签说明，多巴胺本身不易通过血脑屏障，左旋多巴可进入脑内并转化为多巴胺；卡比多巴主要抑制外周左旋多巴脱羧，使更多左旋多巴可供转运至脑部。它解释固定复方的药理路径，不预测个人效果、持续时间、适用性或用量。", "en": "The DailyMed label explains that dopamine itself does not readily cross the blood-brain barrier, while levodopa can reach the brain and be converted to dopamine. Carbidopa mainly inhibits peripheral levodopa decarboxylation, making more levodopa available for transport to the brain. This explains the fixed combination's pharmacologic pathway; it does not predict individual effect, duration, suitability or use." }, "checks": [ { "zh": "左旋多巴进入脑内并转化为多巴胺，是机制描述，不是对任何人的症状原因、改善幅度、持续时间或应服片数的答案。", "en": "Levodopa reaching the brain and becoming dopamine is a mechanism description, not an answer about anyone's symptom cause, degree or duration of benefit, or tablet count." }, { "zh": "卡比多巴主要作用于外周，并不把固定复方变成可任意拆开的两个单药。相同成分名、不同释放方式、不同途径或不同品牌都需要按准确产品单独复核。", "en": "Carbidopa acts mainly in the periphery; it does not turn the fixed combination into two freely separable medicines. A shared ingredient name across release forms, routes or brands still needs exact-product review." }, { "zh": "食物中的某些氨基酸、铁剂与合并药物可能影响这一过程，但机制页面不能换算个人餐时、补服或间隔。多药老人应携带实际药瓶、补充剂和完整清单由药师或处方团队核对。", "en": "Some dietary amino acids, iron and co-medications may affect this process, but a mechanism page cannot calculate personal meal timing, make-up use or spacing. Older people with multiple medicines should bring actual bottles, supplements and the full list for pharmacist or prescribing-team review." } ], "source": { "id": "src_8ea7dd73b92efe4f", "label": "DailyMed（NLM）：SINEMET 当前美国公开标签（Clinical Pharmacology；Organon；2026-07 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=9b17b028-964a-473c-823d-81423535bd66", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-05", "reviewedAt": "2026-09-05" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "Sinemet", "generic": "卡比多巴/左旋多巴（复方）", "dosageFormClass": "当前供应段列出即释口服复方片 10 mg/100 mg 与 25 mg/100 mg；25 mg/250 mg 已不再营销" }, "labelSource": { "id": "src_8ea7dd73b92efe4f", "label": "DailyMed（NLM）：SINEMET 当前美国公开标签与结构化 NDC 数据（Organon；2026-07 修订；2026-08-24 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=9b17b028-964a-473c-823d-81423535bd66", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-05", "reviewedAt": "2026-09-05" }, "productRoutes": [ { "source": { "id": "src_8ea7dd73b92efe4f", "label": "DailyMed（NLM）：SINEMET 当前美国公开标签与结构化 NDC 数据（Organon；2026-07 修订；2026-08-24 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=9b17b028-964a-473c-823d-81423535bd66", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-05", "reviewedAt": "2026-09-05" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-09-05", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-09-05", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [ { "id": "fda-2026-carbidopa-levodopa-vitamin-b6-seizure-safety-communication", "issuedAt": "2026-03-20", "status": "fda_drug_safety_communication", "title": { "zh": "FDA 药物安全通讯：含卡比多巴/左旋多巴产品的维生素 B6 缺乏与癫痫发作警告", "en": "FDA Drug Safety Communication: vitamin B6 deficiency and seizures warning for carbidopa/levodopa products" }, "summary": { "zh": "FDA 于 2026-03-20 发布安全通讯，要求所有含卡比多巴/左旋多巴产品在处方信息中加入维生素 B6 缺乏及相关癫痫发作警告；公告明确列出 Sinemet 和 Sinemet CR。该通讯覆盖多种剂型和途径，不能据此推断任何个人是否存在风险、是否需要检测或补充，亦不能据此自行停药、改变剂型或调整用药。请在手中准确产品与现行说明书的语境下由开方团队或药师核对。", "en": "On 2026-03-20, FDA issued a Drug Safety Communication requiring all carbidopa/levodopa products to add a warning about vitamin B6 deficiency and associated seizures; the communication explicitly lists Sinemet and Sinemet CR. It covers multiple forms and routes, but cannot determine an individual’s risk, need for testing or supplementation, or support self-stopping, form changes or dose changes. Review the exact product and current label with the prescribing team or pharmacist." }, "source": { "id": "src_8e24316f2d733113", "label": "FDA：2026-03-20 含卡比多巴/左旋多巴产品维生素 B6 缺乏与癫痫发作药物安全通讯", "url": "https://www.fda.gov/drugs/drug-safety-communications/fda-requiring-warning-about-vitamin-b6-deficiency-and-associated-seizures-drug-products-containing", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "DailyMed 的 SINEMET（carbidopa and levodopa）当前美国公开标签列出即释口服固定复方片。当前 HOW SUPPLIED 只列 NDC 78206-166-01（10/100、有刻痕）与 NDC 78206-190-01（25/100、无刻痕）；同页结构化数据仍保留已结束的 NDC 78206-168-01（25/100、有刻痕，结束于 2026-02-21）和 NDC 78206-167-01（25/250，结束于 2021-06-02）。档案把当前与历史包装明确分层，不把无结束日期解释成实时库存，也不生成个人片数、时间表、漏用、餐食、联用、转换或停药方案。", "history": "FDA 后续公开审评资料支持 SINEMET 于 1975 年获批，但其中一份文件对精确日期存在单处不一致；因此本页只公开年份。当前阅读入口是 2026-07 修订、2026-08-24 发布的 Organon/DailyMed v6 标签；2026-03-19 的 S-076 批准函作为标签更新节点保留。中国大陆商品名、现行 NMPA 状态与可获得性尚未建立，不从美国档案外推。", "sourceDocuments": [ { "id": "src_8ea7dd73b92efe4f", "label": "DailyMed（NLM）：SINEMET 当前美国公开标签与结构化 NDC 数据（Organon；2026-07 修订；2026-08-24 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=9b17b028-964a-473c-823d-81423535bd66", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-05", "reviewedAt": "2026-09-05" }, { "id": "src_3bc195e8a700b754", "label": "DailyMed（NLM）：SINEMET 当前美国电子说明书 PDF（Organon；2026-07 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/getFile.cfm?setid=9b17b028-964a-473c-823d-81423535bd66&type=pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "electronic_label_pdf", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-05", "reviewedAt": "2026-09-05" }, { "id": "src_69e8c207a6f25f6b", "label": "FDA：SINEMET NDA 017555 S-076 批准函（2026-03-19）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/017555Orig1s076ltr.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "approval_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_d8b51a230a323587", "label": "FDA：2022 临床药理审评中的 SINEMET 1975 年批准历史线索", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2022/214869Orig1s000ClinPharmR.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "approval_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } ], "applicationNumber": "NDA 017555", "approvalTimeline": [ { "date": "1975", "title": { "zh": "FDA 后续审评资料支持的美国批准年份", "en": "U.S. approval year supported by later FDA reviews" }, "detail": { "zh": "FDA 2022 临床药理审评资料记录 SINEMET 于 1975 年获批；其他 FDA 后续资料对 5 月精确日期存在单处不一致，因此本页只公开年份。", "en": "A 2022 FDA clinical-pharmacology review records SINEMET approval in 1975. Another later FDA source has one conflicting May day, so this page publishes only the year." }, "source": { "id": "src_d8b51a230a323587", "label": "FDA: 2022 clinical-pharmacology review with SINEMET approval-history context", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2022/214869Orig1s000ClinPharmR.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "approval_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, { "date": "2026-03-19", "title": { "zh": "NDA 017555 S-076 批准与标签修订", "en": "NDA 017555 S-076 approval and label revision" }, "detail": { "zh": "FDA 公开批准函记录 S-076 于 2026-03-19 获批；DailyMed 当前标签的修订日亦为该日。", "en": "The FDA public letter records S-076 approval on 19 Mar 2026; the current DailyMed label carries the same revision date." }, "source": { "id": "src_69e8c207a6f25f6b", "label": "FDA: SINEMET NDA 017555 S-076 approval letter", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/017555Orig1s076ltr.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "approval_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, { "date": "2026-08-24", "title": { "zh": "DailyMed 当前 SPL v6 公开", "en": "Current SPL v6 published on DailyMed" }, "detail": { "zh": "DailyMed 当前档案显示正文 Revised 7/2026，v6 于 2026-08-24 发布；当前 HOW SUPPLIED 只列 10/100 NDC 78206-166-01 与 25/100 NDC 78206-190-01，同时结构化数据保留两条有营销结束日期的历史 NDC。", "en": "The current DailyMed record shows text revised Jul 2026 and v6 published 24 Aug 2026. The current How Supplied section lists only 10/100 NDC 78206-166-01 and 25/100 NDC 78206-190-01, while structured data retain two historical NDCs with marketing-end dates." }, "source": { "id": "src_8ea7dd73b92efe4f", "label": "DailyMed: current SINEMET public label and structured NDC data", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=9b17b028-964a-473c-823d-81423535bd66", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-05", "reviewedAt": "2026-09-05" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "两个当前供应段 NDC；两个有结束日期的历史 NDC", "en": "Two NDCs in current How Supplied; two dated historical NDCs" }, "detail": { "zh": "当前供应段列 78206-166-01 与 78206-190-01；结构化记录显示 78206-168-01 于 2026-02-21 结束、78206-167-01 于 2021-06-02 结束。监管记录不证明实时库存。", "en": "The current How Supplied section lists 78206-166-01 and 78206-190-01. Structured records show 78206-168-01 ended 21 Feb 2026 and 78206-167-01 ended 2 Jun 2021. Regulatory records do not prove live stock." } }, { "market": { "zh": "中国大陆、欧盟、日本", "en": "Mainland China, EU, Japan" }, "status": { "zh": "待逐项建立市场记录", "en": "Market record not established" }, "detail": { "zh": "不从美国档案推定当地商品名、批准、规格、供应或原研关系。", "en": "No local trade name, approval, strength, supply or originator relationship is inferred from the U.S. archive." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "同为 25/100，能否把历史有刻痕包装当成当前包装来分片？", "en": "Can the historical scored 25/100 pack be treated as the current pack for splitting?" }, "answer": { "zh": "不能。当前 HOW SUPPLIED 列的是无刻痕 NDC 78206-190-01；有刻痕 NDC 78206-168-01 的营销记录已结束。包装图片、相同强度和旧刻痕不能替代手上准确药瓶、现行标签与药师判断。", "en": "No. The current How Supplied section lists unscored NDC 78206-190-01; the marketing record for scored NDC 78206-168-01 has ended. A package image, shared strength or historical score line cannot replace the exact bottle, current label and pharmacist review." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "dosage-forms-are-part-of-medicine-identity", "how-to-read-a-drug-label" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/sinemet/", "en": "https://origindrug.com/en/drugs/sinemet/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "exelon-patch", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-19", "status": "published_traceable_archive" }, "names": { "brand": "Exelon Patch", "generic": "利斯的明", "aliases": [ "EXELON PATCH", "rivastigmine transdermal system", "rivastigmine patch", "rivastigmine transdermal patch", "利斯的明透皮贴剂", "艾斯能" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": { "value": "艾斯能®", "status": "discovery_cue_requires_target_market_verification", "source": { "id": "src_f8cd7f53465a714f", "label": "天津市医疗保障局：药品支付范围明细中的利斯的明透皮贴剂／艾斯能记录", "url": "https://ylbz.tj.gov.cn/xwzx/tzgg/202412/W020241217555076485828.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "reimbursement_lookup", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" } } }, "identity": { "therapeuticArea": "神经与认知", "sourceArchiveMarket": "美国当前公开处方药标签（正文 2024-05 修订；DailyMed SPL v30 于 2025-10-06 发布）", "dosageFormClass": "经皮缓释贴剂：4.6 mg/24h、9.5 mg/24h、13.3 mg/24h（美国标签所列）", "dosageFormClassCode": "transdermal_system", "route": "经皮", "routeCode": "transdermal", "historicalApprovalEntry": "2007-07-06（FDA 原始批准信所列 EXELON PATCH 首批批准日期）", "archiveSponsorText": "Novartis Pharmaceuticals Corporation / DailyMed（NLM）当前公开标签档案" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-exelon-patch-4-6-ndc-0078-0501-15", "marketCode": "US", "labelVersion": { "zh": "2024-05（DailyMed SPL v30 于 2025-10-06 发布）", "en": "May 2024 revision; DailyMed SPL v30 published 2025-10-06" }, "dosageForm": { "zh": "经皮缓释贴剂", "en": "extended-release transdermal system" }, "route": { "zh": "经皮", "en": "transdermal" }, "routeCodes": [ "transdermal" ], "productCode": "NDC 0078-0501-15", "pouchCode": "NDC 0078-0501-61", "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "delivered_over_24_hours", "primaryDisplay": { "zh": "4.6 mg/24h 标称释放；贴内总量 9 mg；面积 5 cm²", "en": "4.6 mg/24h nominal delivery; 9 mg total in the system; 5 cm²" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=07c12e14-bbd5-4ec8-84e4-fbe7b5ba10e0&type=img&name=exelon-patch-0B.jpg", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "利斯的明", "en": "rivastigmine" }, "value": 4.6, "unit": "mg", "basisCode": "delivered_over_24_hours", "basisLabel": { "zh": "24 小时标称释放量", "en": "nominal amount delivered over 24 hours" } }, { "ingredient": { "zh": "利斯的明碱", "en": "rivastigmine base" }, "value": 9, "unit": "mg", "basisCode": "total_in_transdermal_system", "basisLabel": { "zh": "每贴总载药量", "en": "total amount in each transdermal system" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": null, "package": { "count": 30, "unit": { "zh": "贴/盒（每袋 1 贴）", "en": "systems per carton (one per pouch)" } }, "physicalClues": { "color": null, "shape": null, "imprint": null, "scoreStatus": null, "patchAreaCm2": 5 }, "comparisonNotice": null, "source": { "id": "src_c39e6ce07cc07204", "label": "DailyMed（NLM）：EXELON PATCH 利斯的明经皮系统当前美国公开标签（Novartis；正文 2024-05 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=07c12e14-bbd5-4ec8-84e4-fbe7b5ba10e0", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-exelon-patch-9-5-ndc-0078-0502-15", "marketCode": "US", "labelVersion": { "zh": "2024-05（DailyMed SPL v30 于 2025-10-06 发布）", "en": "May 2024 revision; DailyMed SPL v30 published 2025-10-06" }, "dosageForm": { "zh": "经皮缓释贴剂", "en": "extended-release transdermal system" }, "route": { "zh": "经皮", "en": "transdermal" }, "routeCodes": [ "transdermal" ], "productCode": "NDC 0078-0502-15", "pouchCode": "NDC 0078-0502-61", "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "delivered_over_24_hours", "primaryDisplay": { "zh": "9.5 mg/24h 标称释放；贴内总量 18 mg；面积 10 cm²", "en": "9.5 mg/24h nominal delivery; 18 mg total in the system; 10 cm²" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=07c12e14-bbd5-4ec8-84e4-fbe7b5ba10e0&type=img&name=exelon-patch-0C.jpg", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "利斯的明", "en": "rivastigmine" }, "value": 9.5, "unit": "mg", "basisCode": "delivered_over_24_hours", "basisLabel": { "zh": "24 小时标称释放量", "en": "nominal amount delivered over 24 hours" } }, { "ingredient": { "zh": "利斯的明碱", "en": "rivastigmine base" }, "value": 18, "unit": "mg", "basisCode": "total_in_transdermal_system", "basisLabel": { "zh": "每贴总载药量", "en": "total amount in each transdermal system" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": null, "package": { "count": 30, "unit": { "zh": "贴/盒（每袋 1 贴）", "en": "systems per carton (one per pouch)" } }, "physicalClues": { "color": null, "shape": null, "imprint": null, "scoreStatus": null, "patchAreaCm2": 10 }, "comparisonNotice": null, "source": { "id": "src_c39e6ce07cc07204", "label": "DailyMed（NLM）：EXELON PATCH 利斯的明经皮系统当前美国公开标签（Novartis；正文 2024-05 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=07c12e14-bbd5-4ec8-84e4-fbe7b5ba10e0", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-exelon-patch-13-3-ndc-0078-0503-15", "marketCode": "US", "labelVersion": { "zh": "2024-05（DailyMed SPL v30 于 2025-10-06 发布）", "en": "May 2024 revision; DailyMed SPL v30 published 2025-10-06" }, "dosageForm": { "zh": "经皮缓释贴剂", "en": "extended-release transdermal system" }, "route": { "zh": "经皮", "en": "transdermal" }, "routeCodes": [ "transdermal" ], "productCode": "NDC 0078-0503-15", "pouchCode": "NDC 0078-0503-61", "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "delivered_over_24_hours", "primaryDisplay": { "zh": "13.3 mg/24h 标称释放；贴内总量 27 mg；面积 15 cm²", "en": "13.3 mg/24h nominal delivery; 27 mg total in the system; 15 cm²" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=07c12e14-bbd5-4ec8-84e4-fbe7b5ba10e0&type=img&name=exelon-patch-0F.jpg", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "利斯的明", "en": "rivastigmine" }, "value": 13.3, "unit": "mg", "basisCode": "delivered_over_24_hours", "basisLabel": { "zh": "24 小时标称释放量", "en": "nominal amount delivered over 24 hours" } }, { "ingredient": { "zh": "利斯的明碱", "en": "rivastigmine base" }, "value": 27, "unit": "mg", "basisCode": "total_in_transdermal_system", "basisLabel": { "zh": "每贴总载药量", "en": "total amount in each transdermal system" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": null, "package": { "count": 30, "unit": { "zh": "贴/盒（每袋 1 贴）", "en": "systems per carton (one per pouch)" } }, "physicalClues": { "color": null, "shape": null, "imprint": null, "scoreStatus": null, "patchAreaCm2": 15 }, "comparisonNotice": null, "source": { "id": "src_c39e6ce07cc07204", "label": "DailyMed（NLM）：EXELON PATCH 利斯的明经皮系统当前美国公开标签（Novartis；正文 2024-05 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=07c12e14-bbd5-4ec8-84e4-fbe7b5ba10e0", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-exelon-patch-9-5-ndc-0078-0502-15", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=07c12e14-bbd5-4ec8-84e4-fbe7b5ba10e0&type=img&name=exelon-patch-0C.jpg", "alt": "EXELON PATCH 利斯的明在美国 DailyMed Novartis 当前公开标签中的 9.5 mg/24h、NDC 0078-0502-15、30 贴装包装面板", "archiveMarket": "美国", "labelVersion": "DailyMed 当前公开标签（Novartis；正文 2024-05 修订，SPL v30 于 2025-10-06 发布）", "presentation": "EXELON PATCH 9.5 mg/24h，贴内总量 18 mg，面积 10 cm²，NDC 0078-0502-15，30 贴装包装面板", "notice": "此图只对应美国当前标签中的 9.5 mg/24h、NDC 0078-0502-15、30 贴包装。它不能代表 4.6 mg/24h、13.3 mg/24h、另一厂家贴剂、口服利斯的明、其他市场或当前可得性；不用于鉴定真伪，也不证明原研身份、可替代性或个人贴用方案。", "source": { "id": "src_c39e6ce07cc07204", "label": "DailyMed（NLM）：EXELON PATCH 当前美国公开标签（Novartis；正文 2024-05 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=07c12e14-bbd5-4ec8-84e4-fbe7b5ba10e0", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "EXELON PATCH 说明书放大阅读：mg/24h、贴内总量与面积是三组不同身份字段", "en": "EXELON PATCH label reading: mg/24h, total patch content and area are different identity fields" }, "summary": { "zh": "本模块以美国 Novartis/DailyMed 当前公开标签为入口，帮助核对 EXELON PATCH、利斯的明经皮系统、24 小时标称释放量、贴内总量、面积、NDC 与包装。它不生成个人贴数、加减量、漏用、重复贴用、口服—贴剂转换或停用方案。", "en": "This module uses the current U.S. Novartis/DailyMed label to check EXELON PATCH, the rivastigmine transdermal system, nominal 24-hour delivery, total patch content, area, NDC and pack. It does not generate an individual patch count, titration, missed-use, duplicate-patch, oral-to-patch conversion or stopping plan." }, "checks": [ { "zh": "贴内总量不等于 24 小时标称释放量：例如 9.5 mg/24h 贴剂内含利斯的明碱总量 18 mg，面积 10 cm²。必须同时核对 mg/24h、总量、面积、NDC 与目标市场。", "en": "Total amount in the patch is not the nominal amount delivered over 24 hours: the 9.5 mg/24h system contains 18 mg total rivastigmine base and has an area of 10 cm². Check mg/24h, total content, area, NDC and market together." }, { "zh": "标签把旧贴未移除和同时使用多贴列为严重用药错误来源。照护记录应分别确认“旧贴已移除”和“新贴已贴上”；若发现重复贴用，不在网页上计算补救量，应使用当地医生、毒物咨询或紧急医疗渠道。", "en": "The label identifies failure to remove an old patch and use of multiple patches as sources of serious medication errors. A caregiver record should separately confirm ‘old patch removed’ and ‘new patch applied’. If duplicate patches are found, do not calculate a remedy online; use local clinician, poison-control or urgent-care routes." }, { "zh": "不能剪开、折叠、损坏或改动贴剂来获得“半量”；包装袋或贴剂不完整时，也不能把它视为正常完整产品。具体处理须回到准确产品的现行标签与药师。", "en": "Do not cut, fold, damage or alter a patch to obtain a ‘half amount’; a damaged pouch or patch is not the same as an intact product. Handling needs the current label for the exact product and pharmacist review." }, { "zh": "标签提示避免长时间外部热源。网页只提示核对加热垫、桑拿、强烈日晒等热暴露问题，不判断任何个人暴露是否安全，也不生成贴用位置或时长方案。", "en": "The label warns against prolonged exposure to external heat. This page only flags questions about heating pads, saunas, strong sun and other heat exposure; it does not decide whether an individual exposure is safe or generate an application-site or duration plan." }, { "zh": "EXELON 胶囊、口服液、品牌贴剂和其他厂家利斯的明贴剂是不同产品形态。不得按 mg 自行换算、叠加、轮换或替换；中断、漏用、换品牌、换强度或口服—贴剂转换须由医生或药师结合准确包装处理。", "en": "EXELON capsules, oral solution, brand patches and another manufacturer's rivastigmine patch are different product forms. Do not self-convert, combine, alternate or substitute them by milligrams; interruption, missed use, brand/strength change or oral-to-patch conversion needs a clinician or pharmacist with the exact package." } ], "source": { "id": "src_c39e6ce07cc07204", "label": "DailyMed（NLM）：EXELON PATCH 当前美国公开标签（Novartis；正文 2024-05 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=07c12e14-bbd5-4ec8-84e4-fbe7b5ba10e0", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "利斯的明贴剂怎样起作用：标签描述可逆胆碱酯酶抑制，但不改变基础病程", "en": "How rivastigmine patch works: the label describes reversible cholinesterase inhibition, not disease modification" }, "summary": { "zh": "当前标签说明确切作用机制尚未完全确定；认为利斯的明通过可逆抑制胆碱酯酶对乙酰胆碱的水解，提高乙酰胆碱浓度并增强胆碱能功能。标签同时明确，没有证据证明它改变基础痴呆病程。", "en": "The current label states that the precise mechanism is not fully established. Rivastigmine is thought to increase acetylcholine by reversibly inhibiting its hydrolysis by cholinesterase, thereby enhancing cholinergic function. The label also states there is no evidence that it alters the course of the underlying dementing process." }, "checks": [ { "zh": "“提高乙酰胆碱”解释药理路径，不等于逆转痴呆、阻止进展或预测任何人的记忆、行为、跌倒或照护需要。", "en": "“Increasing acetylcholine” explains a pharmacologic pathway; it does not mean reversing dementia, stopping progression or predicting anyone's memory, behaviour, falls or care needs." }, { "zh": "随疾病进展及完整胆碱能神经元减少，标签说明作用可能减弱。该文字不能用来判断个人是否继续、加量、减量、暂停或转换产品。", "en": "The label explains that an effect may lessen as disease advances and fewer intact cholinergic neurons remain. This wording cannot decide whether an individual continues, increases, reduces, pauses or changes product." }, { "zh": "经皮给药只是递送方式，不表示与口服利斯的明、另一品牌贴剂或其他胆碱酯酶抑制剂可按 mg 自动替换、叠加或轮换。准确产品、完整药单和照护记录须由专业人员一起核对。", "en": "Transdermal delivery is a delivery route; it does not make oral rivastigmine, another patch brand or another cholinesterase inhibitor automatically substitutable, combinable or alternatable by milligrams. A professional needs the exact product, complete medicine list and care record together." } ], "source": { "id": "src_c39e6ce07cc07204", "label": "DailyMed（NLM）：EXELON PATCH 当前美国公开标签（Clinical Pharmacology；Novartis）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=07c12e14-bbd5-4ec8-84e4-fbe7b5ba10e0", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "Exelon Patch", "generic": "利斯的明", "dosageFormClass": "经皮缓释贴剂：4.6 mg/24h、9.5 mg/24h、13.3 mg/24h（美国标签所列）" }, "labelSource": { "id": "src_c39e6ce07cc07204", "label": "DailyMed（NLM）：EXELON PATCH 当前美国公开标签（Novartis；正文 2024-05 修订，SPL v30 于 2025-10-06 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=07c12e14-bbd5-4ec8-84e4-fbe7b5ba10e0", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "productRoutes": [ { "source": { "id": "src_c39e6ce07cc07204", "label": "DailyMed（NLM）：EXELON PATCH 当前美国公开标签（Novartis；正文 2024-05 修订，SPL v30 于 2025-10-06 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=07c12e14-bbd5-4ec8-84e4-fbe7b5ba10e0", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "DailyMed 的 EXELON PATCH（rivastigmine transdermal system）当前美国公开标签列出三种 24 小时标称释放量。页面把 mg/24h、每贴总载药量、贴剂面积、NDC 与 30 贴包装分开显示，避免把 9.5 mg/24h 误读为贴内只有 9.5 mg；它不生成个人贴数、开始、加减量、漏用、重复贴用、口服—贴剂转换或停用方案。", "history": "EXELON 口服制剂于 2000 年获批，EXELON PATCH NDA 022083 则于 2007-07-06 首批批准；13.3 mg/24h 规格在 2012 年 S-016 获批。当前标签页中的 Initial U.S. Approval: 2000 不能被误写为贴剂批准时间。中国大陆和其他市场的名称、规格、包装与现行状态须独立核验。", "sourceDocuments": [ { "id": "src_c39e6ce07cc07204", "label": "DailyMed（NLM）：EXELON PATCH 当前美国公开标签（Novartis；正文 2024-05 修订，SPL v30 于 2025-10-06 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=07c12e14-bbd5-4ec8-84e4-fbe7b5ba10e0", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_2680c298152ad484", "label": "FDA：EXELON PATCH NDA 022083 原始批准信（2007-07-06）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/022083s000_Approv.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "approval_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_bad6528c9cf11980", "label": "FDA：EXELON PATCH 13.3 mg/24h S-016 审评资料（2012）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/022083orig1s016.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "approval_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } ], "applicationNumber": "NDA 022083", "approvalTimeline": [ { "date": "2000-04-21", "title": { "zh": "EXELON 口服制剂历史批准节点", "en": "Historical EXELON oral-product approval node" }, "detail": { "zh": "FDA 贴剂批准资料说明 2000 年节点属于 EXELON 胶囊/口服液 NDA 020823，不是贴剂批准日期。", "en": "FDA patch approval material explains that the 2000 node belongs to EXELON capsules/oral solution under NDA 020823, not to patch approval." }, "source": { "id": "src_2680c298152ad484", "label": "FDA: EXELON PATCH NDA 022083 original approval letter", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/022083s000_Approv.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "approval_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, { "date": "2007-07-06", "title": { "zh": "EXELON PATCH 首批批准", "en": "Initial EXELON PATCH approval" }, "detail": { "zh": "FDA 原始批准信记录 4.6 mg/24h 与 9.5 mg/24h EXELON PATCH 于 2007-07-06 获批。", "en": "The FDA original letter records approval of the 4.6 mg/24h and 9.5 mg/24h EXELON PATCH presentations on 6 Jul 2007." }, "source": { "id": "src_2680c298152ad484", "label": "FDA: EXELON PATCH NDA 022083 original approval letter", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/022083s000_Approv.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "approval_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, { "date": "2012-08-31", "title": { "zh": "13.3 mg/24h 规格批准节点", "en": "13.3 mg/24h presentation approval node" }, "detail": { "zh": "FDA S-016 审评资料记录 13.3 mg/24h、15 cm²、贴内总量 27 mg 的补充规格节点。", "en": "FDA S-016 review material records the 13.3 mg/24h, 15 cm², 27 mg total-content supplemental presentation." }, "source": { "id": "src_bad6528c9cf11980", "label": "FDA: EXELON PATCH S-016 review material", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/022083orig1s016.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "approval_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, { "date": "2024-05-08", "title": { "zh": "当前处方信息修订/更新", "en": "Current prescribing-information revision/update" }, "detail": { "zh": "DailyMed 页面列示正文 Revised 05/2024，并将 Drug Label Information Updated 标为 2024-05-08。", "en": "DailyMed lists the text as Revised 05/2024 and Drug Label Information Updated as 8 May 2024." }, "source": { "id": "src_c39e6ce07cc07204", "label": "DailyMed: current EXELON PATCH public label", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=07c12e14-bbd5-4ec8-84e4-fbe7b5ba10e0", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, { "date": "2025-10-06", "title": { "zh": "DailyMed SPL v30 公开", "en": "SPL v30 published on DailyMed" }, "detail": { "zh": "DailyMed 的 Published Date 为 2025-10-06；该日期不被解释成 2025 年发生新的临床修订。", "en": "DailyMed lists 6 Oct 2025 as the Published Date; it is not treated as a new 2025 clinical revision." }, "source": { "id": "src_c39e6ce07cc07204", "label": "DailyMed: current EXELON PATCH public label", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=07c12e14-bbd5-4ec8-84e4-fbe7b5ba10e0", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "已链接当前标签与 NDA 节点", "en": "Current label and NDA nodes linked" }, "detail": { "zh": "产品呈现对应 Novartis/DailyMed 当前美国标签和公开历史文件。", "en": "The product presentations correspond to the current Novartis/DailyMed U.S. label and public historical documents." } }, { "market": { "zh": "中国大陆、欧盟、日本及其他市场", "en": "Mainland China, EU, Japan and other markets" }, "status": { "zh": "待逐项建立市场记录", "en": "Market record not established" }, "detail": { "zh": "地区名称、规格、包装、法定说明书与供应状态须独立核验。", "en": "Regional names, strengths, packs, legal labels and supply status require independent review." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "9.5 mg/24h 是否表示贴内总共只有 9.5 mg？", "en": "Does 9.5 mg/24h mean the patch contains only 9.5 mg in total?" }, "answer": { "zh": "不是。美国标签列示该贴剂面积 10 cm²、贴内总量 18 mg、24 小时标称释放 9.5 mg。", "en": "No. The U.S. label lists a 10 cm² patch containing 18 mg total with nominal delivery of 9.5 mg over 24 hours." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "dosage-forms-are-part-of-medicine-identity", "how-to-read-a-drug-label" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/exelon-patch/", "en": "https://origindrug.com/en/drugs/exelon-patch/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "augmentin", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-21", "status": "published_traceable_archive" }, "names": { "brand": "Augmentin", "generic": "阿莫西林/克拉维酸钾", "aliases": [ "奥格门汀", "amoxicillin clavulanate", "amoxicillin/clavulanate potassium" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "感染", "sourceArchiveMarket": "美国 FDA 2026 公开标签档案", "dosageFormClass": "口服片剂、口服混悬液及咀嚼片（FDA 2026 公开标签所列）", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "1984（FDA 2026 公开标签所列美国初始批准）", "archiveSponsorText": "FDA 美国公开标签档案" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-augmentin-tablet-250mg-125mg-ndc-81964-018-30", "marketCode": "US", "labelVersion": { "zh": "FDA 美国处方信息（2026；仅为所引标签展示面，不代表供应）", "en": "FDA U.S. prescribing information (2026; cited label panel only, not availability)" }, "dosageForm": { "zh": "AUGMENTIN 阿莫西林/克拉维酸钾口服薄膜衣片", "en": "AUGMENTIN amoxicillin/clavulanate potassium film-coated oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 81964-018-30", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片 250 mg / 125 mg；30 片瓶装（美国 FDA 2026 标签文字）", "en": "250 mg / 125 mg per tablet; 30-tablet bottle (FDA U.S. 2026 label text)" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "阿莫西林", "en": "amoxicillin" }, "value": 250, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标示量；不是个人片数或可自行换算的数量", "en": "labelled amount per tablet; not an individual's tablet count or self-conversion" } }, { "ingredient": { "zh": "克拉维酸", "en": "clavulanic acid" }, "value": 125, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标示量；必须与阿莫西林成分一同核对", "en": "labelled amount per tablet; check together with the amoxicillin component" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": null, "package": { "count": 30, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "白色", "en": "white" }, "shape": { "zh": "椭圆形薄膜衣片", "en": "oval film-coated tablet" }, "imprint": "AUGMENTIN / 250/125", "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_1cf9523d380cb101", "label": "FDA：AUGMENTIN 2026 美国处方信息（精确片剂强度、NDC 与包装数量）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/050785s022lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-augmentin-tablet-500mg-125mg-ndc-81964-006-14", "marketCode": "US", "labelVersion": { "zh": "FDA 美国处方信息（2026；仅为所引标签展示面，不代表供应）", "en": "FDA U.S. prescribing information (2026; cited label panel only, not availability)" }, "dosageForm": { "zh": "AUGMENTIN 阿莫西林/克拉维酸钾口服薄膜衣片", "en": "AUGMENTIN amoxicillin/clavulanate potassium film-coated oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 81964-006-14", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片 500 mg / 125 mg；20 片瓶装（美国 FDA 2026 标签文字）", "en": "500 mg / 125 mg per tablet; 20-tablet bottle (FDA U.S. 2026 label text)" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "阿莫西林", "en": "amoxicillin" }, "value": 500, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标示量；不是个人片数或可自行换算的数量", "en": "labelled amount per tablet; not an individual's tablet count or self-conversion" } }, { "ingredient": { "zh": "克拉维酸", "en": "clavulanic acid" }, "value": 125, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标示量；必须与阿莫西林成分一同核对", "en": "labelled amount per tablet; check together with the amoxicillin component" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 20, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": null, "package": { "count": 20, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "白色", "en": "white" }, "shape": { "zh": "椭圆形薄膜衣片", "en": "oval film-coated tablet" }, "imprint": "AUGMENTIN / 500/125", "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_1cf9523d380cb101", "label": "FDA：AUGMENTIN 2026 美国处方信息（精确片剂强度、NDC 与包装数量）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/050785s022lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-augmentin-tablet-875mg-125mg-ndc-81964-021-14", "marketCode": "US", "labelVersion": { "zh": "FDA 美国处方信息（2026；仅为所引标签展示面，不代表供应）", "en": "FDA U.S. prescribing information (2026; cited label panel only, not availability)" }, "dosageForm": { "zh": "AUGMENTIN 阿莫西林/克拉维酸钾口服薄膜衣片", "en": "AUGMENTIN amoxicillin/clavulanate potassium film-coated oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 81964-021-14", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片 875 mg / 125 mg；20 片瓶装（美国 FDA 2026 标签文字）", "en": "875 mg / 125 mg per tablet; 20-tablet bottle (FDA U.S. 2026 label text)" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "阿莫西林", "en": "amoxicillin" }, "value": 875, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标示量；不是个人片数或可自行换算的数量", "en": "labelled amount per tablet; not an individual's tablet count or self-conversion" } }, { "ingredient": { "zh": "克拉维酸", "en": "clavulanic acid" }, "value": 125, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标示量；必须与阿莫西林成分一同核对", "en": "labelled amount per tablet; check together with the amoxicillin component" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 20, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": null, "package": { "count": 20, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "白色", "en": "white" }, "shape": { "zh": "胶囊形薄膜衣片", "en": "capsule-shaped film-coated tablet" }, "imprint": "AUGMENTIN 875", "scoreStatus": "scored_status_not_a_split_instruction", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_1cf9523d380cb101", "label": "FDA：AUGMENTIN 2026 美国处方信息（精确片剂强度、NDC 与包装数量）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/050785s022lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "status": "withheld_repackaged_or_non_exact_visual", "title": { "zh": "未建立准确原品牌包装对应关系，故不展示包装图片", "en": "No exact original-brand package correspondence was established, so no package visual is shown" }, "summary": { "zh": "此次核验的 DailyMed AUGMENTIN 图像来自 Dr. Reddy’s Laboratories 的 2016 公开标签，覆盖片剂、口服混悬液粉末和咀嚼片等多种不同产品呈现；图片本身未被确认可一一对应本档案的准确原品牌、当前强度、剂型和包装。为避免将历史或多呈现标签图误读为准确原品牌外观，本档案不展示该图片，只保留 FDA 和公开标签作为文字核验入口。", "en": "The reviewed DailyMed AUGMENTIN image comes from a 2016 public label for Dr. Reddy’s Laboratories that covers tablets, powder for oral suspension and chewable tablets across multiple presentations. The image itself was not confirmed as a one-to-one match for this dossier’s exact original-brand, current strength, form and package. To avoid treating a historical or multi-presentation label image as exact original-brand appearance, this dossier withholds the image and retains the FDA and public labels as text-verification entries." }, "source": { "id": "src_cb4896c41b116878", "label": "DailyMed（NLM）：AUGMENTIN 2016 公开标签（Dr. Reddy’s Laboratories）", "url": "https://www.dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=174cc098-fe49-4f1a-87e2-601c7573f0db&type=display", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "AUGMENTIN 说明书放大阅读：两个数字对应两个成分，不能只看阿莫西林", "en": "AUGMENTIN label reading: two numbers describe two ingredients, not amoxicillin alone" }, "summary": { "zh": "本模块以 DailyMed 公开标签为阅读入口，说明 AUGMENTIN 的阿莫西林/克拉维酸钾复方标示、片剂、口服混悬液和咀嚼片之间需要怎样先核对身份；它不生成个人片数、毫升数、疗程或抗菌药选择方案。", "en": "This module uses a DailyMed public label as a reading entry point. It explains how to first identify the amoxicillin/clavulanate potassium combination, tablets, oral suspension and chewable tablets; it does not generate an individual tablet count, millilitre amount, course or antibacterial-medicine choice." }, "checks": [ { "zh": "250 mg/125 mg、500 mg/125 mg、875 mg/125 mg 分别同时标示阿莫西林与克拉维酸的量；“总毫克数”或其中一个数字都不能单独代表完整产品。先核对两个成分、剂型和目标市场。", "en": "250 mg/125 mg, 500 mg/125 mg and 875 mg/125 mg each state amounts for both amoxicillin and clavulanate. A total milligram number or either number alone does not identify the complete product. First check both ingredients, dosage form and target market." }, { "zh": "该公开标签明确指出：两片 250 mg/125 mg 片剂不能替代一片 500 mg/125 mg 片剂，因为克拉维酸部分不同。这是产品身份与标签阅读提示，不是自行调整服用数量的公式。", "en": "This public label explicitly states that two 250 mg/125 mg tablets should not be substituted for one 500 mg/125 mg tablet because the clavulanate component differs. This is a product-identity and label-reading point, not a formula for self-adjusting the number of tablets." }, { "zh": "口服混悬液以“每 5 mL 含两种成分”的方式标示；不同浓度、量取工具、复溶与保存要求都必须跟随这一瓶实际产品的现行标签和处方。不能把片剂数字直接换算成儿童或成人的毫升数。", "en": "Oral suspension is labelled as two ingredients per 5 mL. Different concentrations, measuring devices, reconstitution and storage requirements must follow the current label and prescription for the actual bottle. Tablet numbers cannot be directly converted into a child’s or adult’s millilitre amount." }, { "zh": "某些包装的刻痕、咀嚼片或混悬液外观是识别线索，不是对任意掰开、研碎、替换或合用的许可。出现过敏史、胃肠不适、正在服用多种药物或需要调整时，请带实际包装与完整药单联系医生或药师。", "en": "A score mark, chewable tablet or suspension appearance can be an identification clue, not permission to split, crush, substitute or combine products. With allergy history, gastrointestinal symptoms, multiple medicines or a need to adjust treatment, take the actual pack and complete medicine list to a clinician or pharmacist." } ], "source": { "id": "src_cb4896c41b116878", "label": "DailyMed（NLM）：AUGMENTIN 公开标签", "url": "https://www.dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=174cc098-fe49-4f1a-87e2-601c7573f0db&type=display", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "阿莫西林/克拉维酸怎样起作用：一个作用于细菌细胞壁，另一个可抑制部分 β-内酰胺酶", "en": "How amoxicillin/clavulanate works: one acts at the bacterial cell wall and the other may inhibit some beta-lactamases" }, "summary": { "zh": "FDA 标签说明，阿莫西林与细菌细胞壁中的青霉素结合蛋白结合并抑制细胞壁合成；克拉维酸是与青霉素结构相关的 β-内酰胺，可使某些 β-内酰胺酶失活。这解释为什么它是两种成分的复方抗菌药，不诊断感染、不决定个人片数、毫升数、疗程或是否需要抗菌药。", "en": "The FDA label explains that amoxicillin binds penicillin-binding proteins in the bacterial cell wall and inhibits cell-wall synthesis; clavulanic acid is a beta-lactam related in structure to penicillin that may inactivate some beta-lactamase enzymes. This explains why it is a two-ingredient antibacterial combination; it does not diagnose infection or decide an individual's tablet count, millilitre amount, course or need for an antibacterial." }, "checks": [ { "zh": "“含阿莫西林”或“可抑制部分 β-内酰胺酶”都不能判断发热、咳嗽、咽痛、腹泻或其他症状一定由细菌引起，更不能据此自行开始、续用或把家中剩药给其他人。是否需要抗菌药必须结合诊断、检查和准确产品的现行标签。", "en": "Neither “contains amoxicillin” nor “may inhibit some beta-lactamases” can show that fever, cough, sore throat, diarrhoea or another symptom is definitely bacterial, or justify self-starting, continuing or sharing leftovers. Whether an antibacterial is needed requires diagnosis, testing and the current label for the exact product." }, { "zh": "双成分机制不让 AUGMENTIN 与阿莫西林单药、其他青霉素类、头孢类或其他抗菌药可自行叠加、替换或按一个数字换算。两个成分、剂型、强度、过敏史和完整药单必须一起交由专业人员核对。", "en": "A two-ingredient mechanism does not make AUGMENTIN self-combinable, substitutable or convertible by one number with amoxicillin alone, another penicillin, cephalosporin or another antibacterial. Both ingredients, dosage form, strength, allergy history and the complete medicine list need professional review together." }, { "zh": "机制不能把 250 mg/125 mg、500 mg/125 mg、875 mg/125 mg、咀嚼片或混悬液变成自行增减、掰分或转换的方案。尤其涉及皮疹、呼吸不适、严重腹泻或其他新症状时，应及时使用当地医疗支持，而不是从机制页面推断下一步。", "en": "Mechanism cannot turn 250 mg/125 mg, 500 mg/125 mg, 875 mg/125 mg, chewable tablets or suspension into a self-made increase, reduction, splitting or conversion plan. Especially with rash, breathing trouble, severe diarrhoea or another new symptom, use timely local medical support rather than infer the next step from a mechanism page." } ], "source": { "id": "src_1cf9523d380cb101", "label": "FDA：AUGMENTIN 2026 美国处方信息（微生物学）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/050785s022lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "Augmentin", "generic": "阿莫西林/克拉维酸钾", "dosageFormClass": "口服片剂、口服混悬液及咀嚼片（FDA 2026 公开标签所列）" }, "labelSource": { "id": "src_cb4896c41b116878", "label": "DailyMed（NLM）：AUGMENTIN 公开标签", "url": "https://www.dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=174cc098-fe49-4f1a-87e2-601c7573f0db&type=display", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "productRoutes": [ { "source": { "id": "src_cb4896c41b116878", "label": "DailyMed（NLM）：AUGMENTIN 公开标签", "url": "https://www.dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=174cc098-fe49-4f1a-87e2-601c7573f0db&type=display", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_1cf9523d380cb101", "label": "FDA：AUGMENTIN 2026 美国处方信息", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/050785s022lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "DailyMed 的 AUGMENTIN（amoxicillin/clavulanate potassium）公开标签将其列为阿莫西林与克拉维酸钾的口服复方制剂，并列示片剂、口服混悬液和咀嚼片。该页面用于阅读具体产品、剂型和两个成分的标示方式；不据此推定中国大陆或其他市场的当前批准、规格、持有人、原研关系、供应或可售资格。", "history": "复方包装上的两个数字分别对应两种成分的标示量；相同的“阿莫西林 mg”不自动代表克拉维酸部分、剂型或产品可以换算。抗菌药是否适用、具体剂型、实际用量和疗程必须由诊断、处方与目标市场的现行标签共同核对。", "sourceDocuments": [ { "id": "src_1cf9523d380cb101", "label": "FDA：AUGMENTIN 2026 美国处方信息", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/050785s022lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_cb4896c41b116878", "label": "DailyMed（NLM）：AUGMENTIN 公开标签", "url": "https://www.dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=174cc098-fe49-4f1a-87e2-601c7573f0db&type=display", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_5ed30b676fbb9773", "label": "FDA Drugs@FDA 官方检索入口", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_lookup_entry", "documentKind": "regulatory_lookup", "market": "US", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } ], "applicationNumber": "NDA 050564 / 050575 / 050597 / 050720 / 050725 / 050726", "approvalTimeline": [ { "date": "1984", "title": { "zh": "FDA 标签所列美国初始批准年份", "en": "Initial U.S. approval year listed in the FDA label" }, "detail": { "zh": "本页链接的 FDA 标签档案列示 Initial U.S. Approval: 1984。该历史定位不等同于当前批准、可得性、持有人或其他市场状态。", "en": "The FDA label archive linked here lists Initial U.S. Approval: 1984. This historical locator is not a conclusion about current approval, availability, holder or another market." }, "source": { "id": "src_1cf9523d380cb101", "label": "FDA: AUGMENTIN prescribing information", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/050785s022lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, { "date": "2026", "title": { "zh": "FDA 标签档案版本", "en": "FDA label archive version" }, "detail": { "zh": "本页链接 2026 的 FDA 标签档案作为可复核阅读入口。现行标签、规格、适应症和安全信息必须另行以目标市场当前文件核对。", "en": "This page links the 2026 FDA label archive as a traceable reading entry point. Current labeling, strength, indication and safety information require separate verification against the target market’s current document." }, "source": { "id": "src_1cf9523d380cb101", "label": "FDA: AUGMENTIN prescribing information", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/050785s022lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "已链接公开标签档案", "en": "Public label archive linked" }, "detail": { "zh": "仅对应本页所列 FDA 文件。", "en": "Only the FDA document listed on this page is linked." } }, { "market": { "zh": "中国大陆、欧盟、日本", "en": "Mainland China, EU, Japan" }, "status": { "zh": "待逐项建立市场记录", "en": "Market record not established" }, "detail": { "zh": "不从美国标签档案推定当地批准、持有人、规格、供应或可售资格。", "en": "No local approval, holder, strength, supply or sale-eligibility conclusion is inferred from the U.S. label archive." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "标签档案能代表现在的产品信息吗？", "en": "Does a label archive represent current product information?" }, "answer": { "zh": "不能自动代表。档案用于定位来源；需要以目标市场的现行官方标签逐项复核。", "en": "Not automatically. The archive locates a source; each point needs verification against the target market’s current official label." } }, { "question": { "zh": "为什么这里不展示价格或原研/仿制结论？", "en": "Why are price and originator/generic conclusions not shown?" }, "answer": { "zh": "这些结论需要产品、剂型、规格、包装、市场、日期和原始记录分别齐全并经人工审核；单一标签文件不足以支持。", "en": "Those conclusions require separately complete and human-reviewed product, dosage-form, strength, pack, market, date and primary-record fields; one label file is insufficient." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "how-to-read-a-drug-label", "regulatory-sources-first" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/augmentin/", "en": "https://origindrug.com/en/drugs/augmentin/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "zithromax", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-21", "status": "published_traceable_archive" }, "names": { "brand": "Zithromax", "generic": "阿奇霉素", "aliases": [ "azithromycin", "azithromycin dihydrate", "阿奇霉素", "阿奇霉素片", "希舒美" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": { "value": "希舒美®", "status": "discovery_cue_requires_target_market_verification", "source": { "id": "src_f58611eca6505338", "label": "张家港市人民政府：2026 年常用药品价格监测中的希舒美／阿奇霉素片 0.25 g 记录", "url": "https://www.zjg.gov.cn/zjg/ylws_zxxx/202604/a9cd937d408d43579399e38104c035cd.shtml", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "government_medicine_listing", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-12", "reviewedAt": "2026-09-12" } } }, "identity": { "therapeuticArea": "感染", "sourceArchiveMarket": "美国当前公开处方药标签（DailyMed SPL v49，2026-07-29 发布；不代表供应）", "dosageFormClass": "薄膜衣口服片与口服混悬液用粉末（本档案所列）", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "1991（DailyMed 当前美国公开标签所列美国初始批准）", "archiveSponsorText": "DailyMed（NLM）当前美国公开标签；Pfizer Laboratories Div Pfizer Inc" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-zithromax-tablet-500mg-ndc-0069-3070-30", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v49，2026-07-29 发布；仅为所引公开标签展示面，不代表供应", "en": "DailyMed SPL v49, published 29 Jul 2026; cited public label panel only, not availability" }, "dosageForm": { "zh": "ZITHROMAX 阿奇霉素口服薄膜衣片", "en": "ZITHROMAX azithromycin oral film-coated tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 0069-3070-30", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片 500 mg；30 片瓶装", "en": "500 mg per tablet; 30-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=zithromax-08.jpg&setid=db52b91e-79f7-4cc1-9564-f2eee8e31c45&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "阿奇霉素", "en": "azithromycin" }, "value": 500, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标示量；不是个人片数、疗程或自行换算", "en": "labelled amount per tablet; not an individual tablet count, course or self-conversion" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-21", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 30, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "粉红色", "en": "pink" }, "shape": { "zh": "改良胶囊形刻字薄膜衣片", "en": "modified capsule-shaped engraved film-coated tablet" }, "imprint": "Pfizer / ZTM500", "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_fa9eb8a54090e379", "label": "DailyMed（NLM）：ZITHROMAX 500 mg、30 片瓶装（NDC 0069-3070-30；Pfizer；SPL v49，2026-07-29 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=db52b91e-79f7-4cc1-9564-f2eee8e31c45", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": null, "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=zithromax-03.jpg&setid=db52b91e-79f7-4cc1-9564-f2eee8e31c45&type=img", "alt": "ZITHROMAX 阿奇霉素片在美国 DailyMed Pfizer 公开标签中的 250 mg、30 片装容器标签图", "archiveMarket": "美国", "labelVersion": "DailyMed 公开标签（Pfizer Laboratories，2026-07 更新）", "presentation": "ZITHROMAX 阿奇霉素片：每片 250 mg、30 片装容器标签图（DailyMed Pfizer Laboratories 公开标签所列）。", "notice": "此为美国 DailyMed Pfizer Laboratories 公开标签中明确对应 ZITHROMAX、阿奇霉素 250 mg、30 片装的容器标签图，只帮助核对品牌、通用名、片剂、标示强度、包装数量和来源；不用于鉴定真伪，也不证明其他规格、其他包装、其他市场标签、当前可得性、原研身份、目标市场批准或可售资格。", "source": { "id": "src_fa9eb8a54090e379", "label": "DailyMed（NLM）：ZITHROMAX 公开标签（Pfizer Laboratories，2026-07 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=db52b91e-79f7-4cc1-9564-f2eee8e31c45", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "ZITHROMAX 说明书放大阅读：片剂与混悬液不能只按“阿奇霉素”或毫克数混看", "en": "ZITHROMAX label reading: tablets and suspension cannot be read from the name or milligrams alone" }, "summary": { "zh": "本模块以美国 DailyMed 公开标签为阅读入口，帮助核对 ZITHROMAX、阿奇霉素、250/500 mg 片剂、口服混悬液用粉末和目标市场。它不诊断感染，也不提供个人片数、毫升数、疗程或替代方案。", "en": "This module uses the U.S. DailyMed public label to check ZITHROMAX, azithromycin, 250/500 mg tablets, powder for oral suspension and target market. It does not diagnose infection or provide an individual tablet count, millilitre amount, course or substitute plan." }, "checks": [ { "zh": "先把 ZITHROMAX、阿奇霉素、准确剂型、每片或每 5 mL 的标示强度、量取工具和目标市场一起核对。250 mg 或 500 mg 是准确产品的身份字段，不是网页替任何人计算“今天吃几片”或“喝几毫升”的答案。", "en": "Check ZITHROMAX, azithromycin, the exact form, stated strength per tablet or per 5 mL, measuring device and target market together. 250 mg or 500 mg identifies an exact product; it is not a web answer to how many tablets or millilitres anyone should use today." }, { "zh": "片剂与口服混悬液即使都含阿奇霉素，也有不同的标示单位、复溶、保存和量取要求。不能按药名、总毫克数、家中量匙或他人的处方自行换算、拼量、延长或重新开始。", "en": "A tablet and oral suspension may both contain azithromycin while having different labelled units, reconstitution, storage and measuring requirements. Do not self-convert, combine strengths, extend or restart based on a name, total milligrams, a household spoon or another person's prescription." }, { "zh": "该标签强调抗菌药应仅用于已证实或强烈怀疑由敏感细菌引起的感染。它不是任何发热、咳嗽、咽痛或腹泻的自我诊断规则，也不能支持把剩药给家人、换用另一种抗菌药或自行决定疗程。", "en": "The label says antibacterial medicines should be used only for infections proven or strongly suspected to be caused by susceptible bacteria. This is not a self-diagnosis rule for fever, cough, sore throat or diarrhoea, and it does not support sharing leftovers, changing to another antibacterial or deciding a course independently." }, { "zh": "正在使用多种处方药、非处方药、补充剂或出现新的严重不适时，应带完整药单和实际包装请医生或药师核对。网页不会判断个人联用、停用、漏用后补救或治疗转换。", "en": "With multiple prescription medicines, OTC products, supplements or a new serious symptom, take the complete medicine list and actual pack to a clinician or pharmacist. A webpage does not decide individual combinations, stopping, missed-use remedies or treatment conversion." } ], "source": { "id": "src_fa9eb8a54090e379", "label": "DailyMed（NLM）：ZITHROMAX 阿奇霉素当前美国公开标签（Pfizer；2026-07 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=db52b91e-79f7-4cc1-9564-f2eee8e31c45", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "阿奇霉素怎样起作用：标签描述其与细菌 50S 核糖体亚基结合，抑制蛋白质合成", "en": "How azithromycin works: the label describes binding to the bacterial 50S ribosomal subunit and inhibition of protein synthesis" }, "summary": { "zh": "DailyMed 标签将阿奇霉素描述为大环内酯类抗菌药，并说明其可与敏感微生物的 50S 核糖体亚基结合、干扰蛋白质合成。机制解释的是药物作用路径；它不确认某个人的症状由细菌引起，也不能决定用哪种抗菌药、剂型、强度或疗程。", "en": "The DailyMed label describes azithromycin as a macrolide antibacterial that can bind the 50S ribosomal subunit of susceptible microorganisms and interfere with protein synthesis. Mechanism explains an action pathway; it does not establish that a person's symptoms are bacterial or decide an antibacterial choice, form, strength or course." }, "checks": [ { "zh": "“抑制细菌蛋白质合成”不是感染诊断，也不说明对所有病原体、所有症状或所有人都适用。是否需要抗菌药必须依赖诊断、检查、准确产品标签和专业判断。", "en": "“Inhibiting bacterial protein synthesis” is not an infection diagnosis and does not show that a medicine fits every pathogen, symptom or person. Whether an antibacterial is needed depends on diagnosis, testing, the exact product label and professional judgement." }, { "zh": "大环内酯类别或共同机制不使阿奇霉素与其他抗菌药、其他阿奇霉素剂型或不同强度可以自行叠加、轮换或以毫克数换算。", "en": "A macrolide class or shared mechanism does not make azithromycin self-combinable, alternatable or convertible by milligrams with another antibacterial, another azithromycin form or a different strength." }, { "zh": "机制页面不能决定疗程、漏用后的补救、是否续用或是否换药。出现不适、需要改变方案或正在用多种产品时，应带实际包装和完整药单联系当地医生或药师。", "en": "A mechanism page cannot decide course length, a missed-use remedy, continuation or switching. With symptoms, a contemplated change or multiple products, contact a local clinician or pharmacist with the actual pack and complete medicine list." } ], "source": { "id": "src_fa9eb8a54090e379", "label": "DailyMed（NLM）：ZITHROMAX 阿奇霉素当前美国公开标签（临床药理；2026-07 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=db52b91e-79f7-4cc1-9564-f2eee8e31c45", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "Zithromax", "generic": "阿奇霉素", "dosageFormClass": "薄膜衣口服片与口服混悬液用粉末（本档案所列）" }, "labelSource": { "id": "src_fa9eb8a54090e379", "label": "DailyMed（NLM）：ZITHROMAX 阿奇霉素当前美国公开标签（Pfizer；2026-07 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=db52b91e-79f7-4cc1-9564-f2eee8e31c45", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "productRoutes": [ { "source": { "id": "src_fa9eb8a54090e379", "label": "DailyMed（NLM）：ZITHROMAX 阿奇霉素当前美国公开标签（Pfizer；2026-07 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=db52b91e-79f7-4cc1-9564-f2eee8e31c45", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "DailyMed 的 ZITHROMAX（azithromycin dihydrate）美国公开标签列示 250 mg、500 mg 薄膜衣口服片以及用于口服混悬液的粉末。页面帮助读者把商品名、通用名、剂型、每单位强度和目标市场放在一起核对；不将包装数字转换为个人片数、毫升数、疗程、换药或购买结论。", "history": "同一阿奇霉素名称可对应不同强度、片剂、口服混悬液和不同市场标签。共同成分或相近数字不能证明可以自行拼量、拆分、把片剂换成混悬液，或把家中剩余抗菌药用于新的症状。", "sourceDocuments": [ { "id": "src_fa9eb8a54090e379", "label": "DailyMed（NLM）：ZITHROMAX 阿奇霉素当前美国公开标签（Pfizer；2026-07 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=db52b91e-79f7-4cc1-9564-f2eee8e31c45", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_5ed30b676fbb9773", "label": "FDA Drugs@FDA 官方检索入口", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_lookup_entry", "documentKind": "regulatory_lookup", "market": "US", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } ], "applicationNumber": "NDA 050670 / 050710 / 050730", "approvalTimeline": [ { "date": "1991", "title": { "zh": "FDA 标签所列美国初始批准年份", "en": "Initial U.S. approval year listed in the FDA label" }, "detail": { "zh": "本页链接的 FDA 标签档案列示 Initial U.S. Approval: 1991。该历史定位不等同于当前批准、可得性、持有人或其他市场状态。", "en": "The FDA label archive linked here lists Initial U.S. Approval: 1991. This historical locator is not a conclusion about current approval, availability, holder or another market." }, "source": { "id": "src_fa9eb8a54090e379", "label": "DailyMed: ZITHROMAX current public label", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=db52b91e-79f7-4cc1-9564-f2eee8e31c45", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, { "date": "2026-07", "title": { "zh": "FDA 标签档案版本", "en": "FDA label archive version" }, "detail": { "zh": "本页链接 2026-07 的 FDA 标签档案作为可复核阅读入口。现行标签、规格、适应症和安全信息必须另行以目标市场当前文件核对。", "en": "This page links the 2026-07 FDA label archive as a traceable reading entry point. Current labeling, strength, indication and safety information require separate verification against the target market’s current document." }, "source": { "id": "src_fa9eb8a54090e379", "label": "DailyMed: ZITHROMAX current public label", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=db52b91e-79f7-4cc1-9564-f2eee8e31c45", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "已链接公开标签档案", "en": "Public label archive linked" }, "detail": { "zh": "仅对应本页所列 FDA 文件。", "en": "Only the FDA document listed on this page is linked." } }, { "market": { "zh": "中国大陆、欧盟、日本", "en": "Mainland China, EU, Japan" }, "status": { "zh": "待逐项建立市场记录", "en": "Market record not established" }, "detail": { "zh": "不从美国标签档案推定当地批准、持有人、规格、供应或可售资格。", "en": "No local approval, holder, strength, supply or sale-eligibility conclusion is inferred from the U.S. label archive." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "标签档案能代表现在的产品信息吗？", "en": "Does a label archive represent current product information?" }, "answer": { "zh": "不能自动代表。档案用于定位来源；需要以目标市场的现行官方标签逐项复核。", "en": "Not automatically. The archive locates a source; each point needs verification against the target market’s current official label." } }, { "question": { "zh": "为什么这里不展示价格或原研/仿制结论？", "en": "Why are price and originator/generic conclusions not shown?" }, "answer": { "zh": "这些结论需要产品、剂型、规格、包装、市场、日期和原始记录分别齐全并经人工审核；单一标签文件不足以支持。", "en": "Those conclusions require separately complete and human-reviewed product, dosage-form, strength, pack, market, date and primary-record fields; one label file is insufficient." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "how-to-read-a-drug-label", "regulatory-sources-first" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/zithromax/", "en": "https://origindrug.com/en/drugs/zithromax/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "xifaxan", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-23", "status": "published_traceable_archive" }, "names": { "brand": "XIFAXAN", "generic": "利福昔明", "aliases": [ "XIFAXAN", "rifaximin", "利福昔明", "昔发明", "xifaxan 200 mg", "xifaxan 550 mg" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "感染", "sourceArchiveMarket": "美国：DailyMed 公开处方药标签（页面显示 2025-06-25 更新）。本页只建立所引文件的阅读入口，不从这一美国文件推定中国大陆、欧盟、日本或其他市场的商品名、批准、供应、可售资格或可替代性。", "dosageFormClass": "利福昔明口服片：200 mg、550 mg（美国公开标签所列；本页精确展示 200 mg、30 片瓶装及 550 mg、60 片瓶装）", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "2004（DailyMed 标签所列美国初始批准年份）", "archiveSponsorText": "Salix Pharmaceuticals, Inc. / DailyMed（NLM）美国公开标签" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [ "rifaximin generic tablet", "rifamycin antibiotic", "利福昔明仿制片" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-xifaxan-rifaximin-tablet-200mg-30-bottle-ndc-65649-301-03", "marketCode": "US", "labelVersion": { "zh": "DailyMed 页面更新 2025-06-25", "en": "DailyMed page updated 25 Jun 2025" }, "dosageForm": { "zh": "XIFAXAN 利福昔明口服片", "en": "XIFAXAN rifaximin oral tablet" }, "route": { "zh": "口服（标签产品身份字段）", "en": "oral (label product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 65649-301-03", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片 200 mg；30 片瓶装（美国标签）", "en": "200 mg labelled per tablet; 30-tablet bottle (U.S. label)" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=image-06.jpg&setid=c5e8e2fd-7087-4b78-9181-cc259c0be2f1&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "利福昔明", "en": "rifaximin" }, "value": 200, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "200 mg 每片标签标示量；不是个人片数、频率、疗程或换算指令", "en": "200 mg labelled per tablet; not an individual's tablet count, frequency, course or conversion instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "片", "en": "tablets" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-23", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 30, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "粉红色", "en": "pink" }, "shape": { "zh": "圆形、双凸片；一面有 Sx 压印，另一面为空白", "en": "round, biconvex tablet; Sx debossed on one side and plain on the other" }, "imprint": "Sx", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_5238bc5c8d2cf958", "label": "DailyMed（NLM）：XIFAXAN 利福昔明美国公开标签（Salix；页面 2025-06-25 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c5e8e2fd-7087-4b78-9181-cc259c0be2f1", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-xifaxan-rifaximin-tablet-550mg-60-bottle-ndc-65649-303-02", "marketCode": "US", "labelVersion": { "zh": "DailyMed 页面更新 2025-06-25", "en": "DailyMed page updated 25 Jun 2025" }, "dosageForm": { "zh": "XIFAXAN 利福昔明口服片", "en": "XIFAXAN rifaximin oral tablet" }, "route": { "zh": "口服（标签产品身份字段）", "en": "oral (label product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 65649-303-02", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片 550 mg；60 片瓶装（美国标签）", "en": "550 mg labelled per tablet; 60-tablet bottle (U.S. label)" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=image-05.jpg&setid=c5e8e2fd-7087-4b78-9181-cc259c0be2f1&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "利福昔明", "en": "rifaximin" }, "value": 550, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "550 mg 每片标签标示量；不是个人片数、频率、疗程或换算指令", "en": "550 mg labelled per tablet; not an individual's tablet count, frequency, course or conversion instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 60, "countUnit": { "zh": "片", "en": "tablets" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-23", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 60, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "粉红色", "en": "pink" }, "shape": { "zh": "椭圆形、双凸片；一面有 rfx 压印，另一面为空白", "en": "oval, biconvex tablet; rfx debossed on one side and plain on the other" }, "imprint": "rfx", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_5238bc5c8d2cf958", "label": "DailyMed（NLM）：XIFAXAN 利福昔明美国公开标签（Salix；页面 2025-06-25 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c5e8e2fd-7087-4b78-9181-cc259c0be2f1", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": null, "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=image-05.jpg&setid=c5e8e2fd-7087-4b78-9181-cc259c0be2f1&type=img", "alt": "XIFAXAN 利福昔明 550 mg、60 片瓶装在美国 DailyMed 公开标签中的主展示面", "archiveMarket": "美国", "labelVersion": "DailyMed 页面更新 2025-06-25", "presentation": "XIFAXAN 550 mg、60 片瓶装主展示面（DailyMed 标签明确对应 NDC 65649-303-02）", "notice": "此为 DailyMed 标签中明确对应的美国 550 mg、60 片瓶装展示面，仅用于核对品牌、通用名、每片标示量、包装数量和来源；不用于鉴定真伪，也不证明其他规格、其他包装、其他市场、当前供应、原研身份或可替代性。", "source": { "id": "src_5238bc5c8d2cf958", "label": "DailyMed（NLM）：XIFAXAN 利福昔明美国公开标签（Salix；页面 2025-06-25 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c5e8e2fd-7087-4b78-9181-cc259c0be2f1", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "XIFAXAN 说明书放大阅读：200 mg 与 550 mg 先是不同的准确产品身份，不是“换算几片”的答案", "en": "XIFAXAN label reading: 200 mg and 550 mg first identify different exact products, not a tablet-conversion answer" }, "summary": { "zh": "本模块以 Salix 的 DailyMed 美国公开标签为阅读入口，帮助核对 XIFAXAN、利福昔明、准确片剂、每片 mg、包装和目标市场。它不提供个人片数、疗程、替换、联用或停药方案。", "en": "This module uses Salix's U.S. DailyMed public label to check XIFAXAN, rifaximin, the exact tablet, milligrams per tablet, package and target market. It does not provide an individual's tablet count, course, substitution, combination or stopping plan." }, "checks": [ { "zh": "先分清 200 mg 圆片与 550 mg 椭圆片，以及手中实际药盒的用途。mg 是每一准确片剂的标示量；两种规格、瓶装数量、药片形状或同属抗菌药，都不是网页能据此推导“应吃几片”“能不能换”“能否补一片”或疗程的答案。", "en": "First distinguish the 200 mg round tablet from the 550 mg oval tablet and check the use on the actual pack. mg is the labelled amount in each exact tablet; the two strengths, bottle counts, shape or antibacterial class do not let a webpage derive a tablet count, substitution, make-up use or course." }, { "zh": "标签将 XIFAXAN 用于特定的细菌相关适应症，并明确其不适合用于全身性细菌感染。感冒等病毒性疾病、发热或便血性腹泻、症状持续或加重，都不能靠网页或旧药盒自行决定是否开始、重复、加量、停用或换用另一种抗菌药。", "en": "The label uses XIFAXAN for specific bacteria-related indications and says it is not suitable for systemic bacterial infections. A viral illness such as a cold, fever or bloody diarrhoea, or persistent/worsening symptoms cannot be used to self-decide whether to start, repeat, increase, stop or change to another antibacterial from a webpage or an old pack." }, { "zh": "标签提示严重肝功能受损及与 P-gp 抑制剂（如环孢素）同用需要谨慎。家中有肝病、移植/免疫相关药、抗感染药、草本、营养补充剂或多种慢病药时，应把每一盒实际包装和完整药单交给药师或开方团队；不要按“肠道药”“不怎么吸收”或名称相似自行叠加、轮换或替代。", "en": "The label calls for caution with severe hepatic impairment and concomitant P-gp inhibitors such as cyclosporine. With liver disease, transplant/immune medicines, anti-infectives, herbs, supplements or multiple chronic medicines at home, have a pharmacist or prescriber review every actual pack and the complete medicine list; do not self-combine, alternate or substitute based on “gut medicine,” limited absorption or a similar name." }, { "zh": "出现呼吸困难、面部/口唇/咽喉肿胀、严重或持续腹泻、便血、发热、明显腹痛、意识改变或其他急性严重不适，应及时使用当地紧急医疗或既有照护渠道；不要等待网页或自行尝试不同规格、不同抗菌药或剩余药。", "en": "With difficult breathing, face/lip/throat swelling, severe or persistent diarrhoea, bloody stool, fever, marked abdominal pain, altered consciousness or another acute serious concern, use local urgent or established care promptly; do not wait for a webpage or self-try another strength, antibacterial or leftovers." } ], "source": { "id": "src_5238bc5c8d2cf958", "label": "DailyMed（NLM）：XIFAXAN 利福昔明美国公开标签（Salix；页面 2025-06-25 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c5e8e2fd-7087-4b78-9181-cc259c0be2f1", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "利福昔明怎样起作用：标签描述其抑制细菌 DNA 依赖 RNA 聚合酶", "en": "How rifaximin works: the label describes inhibition of bacterial DNA-dependent RNA polymerase" }, "summary": { "zh": "标签将利福昔明描述为利福霉素 SV 衍生的半合成、非全身性抗菌药，并说明其通过抑制细菌 DNA 依赖 RNA 聚合酶发挥抗菌活性。这个机制用于理解标签，不能判断个人感染原因、是否需要抗菌药、是否存在耐药、应使用何种方案或能否与其他药同用。", "en": "The label describes rifaximin as a semisynthetic, nonsystemic antibacterial derived from rifamycin SV and says it acts by inhibiting bacterial DNA-dependent RNA polymerase. This mechanism helps read the label; it cannot determine an individual's cause of infection, need for an antibacterial, resistance, regimen or suitability with another medicine." }, "checks": [ { "zh": "“肠道内作用”“非全身性”或“RNA 聚合酶”不是自我诊断工具，也不说明任何腹泻、腹痛、肝病相关症状或旅行后不适都应使用此药。是否为细菌感染、哪一种病原体、是否需要其他检查或治疗，需要专业评估。", "en": "“Acts in the gut,” “nonsystemic” or “RNA polymerase” is not a self-diagnostic tool and does not mean every diarrhoea, abdominal pain, liver-related symptom or post-travel concern should use this medicine. Whether there is a bacterial infection, which pathogen is involved, and whether another test or treatment is needed require professional assessment." }, { "zh": "抗菌药机制不能授权把同一类、不同类或余下的抗菌药自行叠加、轮换、分半、缩短或延长疗程。名称相似、药盒颜色、每片 mg 或包装余量都不足以建立可替代性。", "en": "An antibacterial mechanism does not authorise self-combination, alternation, splitting, shortening or extension with a same-class, different-class or leftover antibacterial. Similar names, pack colour, milligrams per tablet or tablets remaining do not establish interchangeability." }, { "zh": "若症状恶化、持续，或出现发热、便血、过敏样症状、意识改变或其他急性问题，应优先使用当地医疗支持；机制页面不替代检验、处方审核或现场评估。", "en": "If symptoms worsen or persist, or there is fever, bloody stool, an allergy-like symptom, altered consciousness or another acute concern, prioritise local medical support; a mechanism page does not replace testing, prescription review or in-person assessment." } ], "source": { "id": "src_5238bc5c8d2cf958", "label": "DailyMed（NLM）：XIFAXAN 利福昔明美国公开标签（Salix；页面 2025-06-25 更新；Clinical Pharmacology）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c5e8e2fd-7087-4b78-9181-cc259c0be2f1", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "XIFAXAN", "generic": "利福昔明", "dosageFormClass": "利福昔明口服片：200 mg、550 mg（美国公开标签所列；本页精确展示 200 mg、30 片瓶装及 550 mg、60 片瓶装）" }, "labelSource": { "id": "src_5238bc5c8d2cf958", "label": "DailyMed（NLM）：XIFAXAN 利福昔明美国公开标签（Salix；页面 2025-06-25 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c5e8e2fd-7087-4b78-9181-cc259c0be2f1", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "productRoutes": [ { "source": { "id": "src_5238bc5c8d2cf958", "label": "DailyMed（NLM）：XIFAXAN 利福昔明美国公开标签（Salix；页面 2025-06-25 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c5e8e2fd-7087-4b78-9181-cc259c0be2f1", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-23", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-23", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "XIFAXAN 是利福昔明口服片。所引标签列有 200 mg 和 550 mg 两种片剂；mg 是每一准确片剂的标示量，而不是网页能据此算出个人应吃几片、应使用多久或能否把两种规格互换的答案。该标签针对不同病情列出不同专业用药方案，因此先核对手中药盒、处方用途和当前标签比只看数字更重要。", "history": "所引 DailyMed 美国公开标签列示 Initial U.S. Approval: 2004、Salix Pharmaceuticals, Inc. 为包装方，并显示页面更新日期为 2025-06-25。标签将 XIFAXAN 定义为利福霉素类抗菌药，明确其不适合用于全身性细菌感染，并列有发热、便血性腹泻、肝功能严重受损及与 P-gp 抑制剂同用等需要专业判断的警示线索。来源日期和历史节点只定位所引文件，不能替代实际产品的现行说明书、诊断、处方或目标市场记录。", "sourceDocuments": [ { "id": "src_5238bc5c8d2cf958", "label": "DailyMed（NLM）：XIFAXAN 利福昔明美国公开标签（Salix；页面 2025-06-25 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c5e8e2fd-7087-4b78-9181-cc259c0be2f1", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" } ], "applicationNumber": "DailyMed 公开标签所列 New Drug Application 记录（本档案不另行断言具体申请号）", "approvalTimeline": [ { "date": "2004", "title": { "zh": "FDA 标签所列美国初始批准年份", "en": "Initial U.S. approval year listed in the FDA label" }, "detail": { "zh": "本页链接的 FDA 标签档案列示 Initial U.S. Approval: 2004。该历史定位不等同于当前批准、可得性、持有人或其他市场状态。", "en": "The FDA label archive linked here lists Initial U.S. Approval: 2004. This historical locator is not a conclusion about current approval, availability, holder or another market." }, "source": { "id": "src_5238bc5c8d2cf958", "label": "DailyMed: XIFAXAN rifaximin tablet public label", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c5e8e2fd-7087-4b78-9181-cc259c0be2f1", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" } }, { "date": "2025-06-25", "title": { "zh": "FDA 标签档案版本", "en": "FDA label archive version" }, "detail": { "zh": "本页链接 2025-06-25 的 FDA 标签档案作为可复核阅读入口。现行标签、规格、适应症和安全信息必须另行以目标市场当前文件核对。", "en": "This page links the 2025-06-25 FDA label archive as a traceable reading entry point. Current labeling, strength, indication and safety information require separate verification against the target market’s current document." }, "source": { "id": "src_5238bc5c8d2cf958", "label": "DailyMed: XIFAXAN rifaximin tablet public label", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c5e8e2fd-7087-4b78-9181-cc259c0be2f1", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "已链接公开标签档案", "en": "Public label archive linked" }, "detail": { "zh": "仅对应本页所列 FDA 文件。", "en": "Only the FDA document listed on this page is linked." } }, { "market": { "zh": "中国大陆、欧盟、日本", "en": "Mainland China, EU, Japan" }, "status": { "zh": "待逐项建立市场记录", "en": "Market record not established" }, "detail": { "zh": "不从美国标签档案推定当地批准、持有人、规格、供应或可售资格。", "en": "No local approval, holder, strength, supply or sale-eligibility conclusion is inferred from the U.S. label archive." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "标签档案能代表现在的产品信息吗？", "en": "Does a label archive represent current product information?" }, "answer": { "zh": "不能自动代表。档案用于定位来源；需要以目标市场的现行官方标签逐项复核。", "en": "Not automatically. The archive locates a source; each point needs verification against the target market’s current official label." } }, { "question": { "zh": "为什么这里不展示价格或原研/仿制结论？", "en": "Why are price and originator/generic conclusions not shown?" }, "answer": { "zh": "这些结论需要产品、剂型、规格、包装、市场、日期和原始记录分别齐全并经人工审核；单一标签文件不足以支持。", "en": "Those conclusions require separately complete and human-reviewed product, dosage-form, strength, pack, market, date and primary-record fields; one label file is insufficient." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "how-to-read-a-drug-label", "regulatory-sources-first" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/xifaxan/", "en": "https://origindrug.com/en/drugs/xifaxan/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "tamiflu", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-21", "status": "published_traceable_archive" }, "names": { "brand": "Tamiflu", "generic": "奥司他韦", "aliases": [ "oseltamivir" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "感染", "sourceArchiveMarket": "美国当前公开标签档案（DailyMed SPL v45，2025-12-19 发布）", "dosageFormClass": "口服胶囊；口服混悬液用粉末（复溶后）（DailyMed 2025 标签所列）", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "1999（DailyMed 当前公开标签所列美国初始批准）", "archiveSponsorText": "Genentech / DailyMed 公开标签与 FDA 历史监管档案" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-tamiflu-capsule-75mg-10-capsule-blister-ndc-0004-0800-85", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v45，2025-12-19 发布；仅为所引公开标签展示面，不代表供应", "en": "DailyMed SPL v45, published 19 Dec 2025; cited public label panel only, not availability" }, "dosageForm": { "zh": "TAMIFLU 奥司他韦磷酸盐口服胶囊", "en": "TAMIFLU oseltamivir phosphate oral capsule" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 0004-0800-85", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_capsule", "primaryDisplay": { "zh": "每粒 75 mg；10 粒泡罩卡纸盒", "en": "75 mg per capsule; 10-capsule blister-card carton" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=tamiflu-04.jpg&setid=ee3c9555-60f2-4f82-a760-11983c86e97b&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "奥司他韦", "en": "oseltamivir" }, "value": 75, "unit": "mg", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒标签标示量；不是个人粒数、疗程或与混悬液自行换算", "en": "labelled amount per capsule; not an individual's capsule count, course or self-conversion to suspension" } } ], "concentration": null, "container": { "typeCode": "unit_dose_blister", "typeLabel": { "zh": "泡罩卡纸盒", "en": "blister-card carton" }, "fill": null, "countPerPackage": 10, "countUnit": { "zh": "粒/盒", "en": "capsules per carton" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-21", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 10, "unit": { "zh": "粒/盒", "en": "capsules per carton" } }, "physicalClues": { "color": { "zh": "灰色与浅黄色", "en": "grey and light yellow" }, "shape": { "zh": "硬明胶胶囊", "en": "hard gelatin capsule" }, "imprint": "ROCHE / 75 mg", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_5e49cf1bebe9cd67", "label": "DailyMed（NLM）：TAMIFLU 当前公开标签（Genentech；SPL v45，2025-12-19 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ee3c9555-60f2-4f82-a760-11983c86e97b", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-tamiflu-oral-suspension-6mg-per-ml-60ml-bottle-ndc-0004-0822-05", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v45，2025-12-19 发布；仅为所引公开标签展示面，不代表供应", "en": "DailyMed SPL v45, published 19 Dec 2025; cited public label panel only, not availability" }, "dosageForm": { "zh": "TAMIFLU 奥司他韦磷酸盐口服混悬液用粉末（复溶后）", "en": "TAMIFLU oseltamivir phosphate powder for oral suspension (after reconstitution)" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 0004-0822-05", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "concentration", "primaryDisplay": { "zh": "6 mg/mL；60 mL 复溶后可用口服混悬液瓶装", "en": "6 mg/mL; 60 mL usable reconstituted oral-suspension bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=tamiflu-05.jpg&setid=ee3c9555-60f2-4f82-a760-11983c86e97b&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "奥司他韦", "en": "oseltamivir" }, "value": 6, "unit": "mg", "basisCode": "concentration", "basisLabel": { "zh": "标签浓度；不是个人毫升数、配制步骤或与胶囊自行换算", "en": "labelled concentration; not an individual's millilitres, reconstitution steps or self-conversion to capsules" } } ], "concentration": { "basisCode": "mass_per_volume", "notation": "6 mg/mL", "numerator": { "value": 6, "unit": "mg" }, "denominator": { "value": 1, "unit": "mL" }, "display": { "zh": "6 mg/mL（标签浓度；不是个人毫升数）", "en": "6 mg/mL (labelled concentration; not an individual's millilitres)" } }, "container": { "typeCode": "reconstitution_bottle", "typeLabel": { "zh": "复溶后口服混悬液瓶装", "en": "reconstituted oral-suspension bottle" }, "fill": { "value": 60, "unit": "mL" }, "countPerPackage": 1, "countUnit": { "zh": "瓶/盒", "en": "bottle per carton" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-21", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 1, "unit": { "zh": "瓶/盒", "en": "bottle per carton" } }, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_5e49cf1bebe9cd67", "label": "DailyMed（NLM）：TAMIFLU 当前公开标签（Genentech；SPL v45，2025-12-19 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ee3c9555-60f2-4f82-a760-11983c86e97b", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-tamiflu-capsule-75mg-10-capsule-blister-ndc-0004-0800-85", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=tamiflu-04.jpg&setid=ee3c9555-60f2-4f82-a760-11983c86e97b&type=img", "alt": "TAMIFLU 75 mg 奥司他韦胶囊在美国 DailyMed 公开标签中的 Genentech 10 粒装包装主展示图", "archiveMarket": "美国", "labelVersion": "DailyMed SPL v45（2025-12-19 发布）", "presentation": "TAMIFLU 75 mg、10 粒胶囊装包装主展示图（DailyMed 公开标签所列；Genentech 标签图）。", "notice": "此为美国 DailyMed 公开标签中明确对应 TAMIFLU 75 mg、10 粒胶囊装的 Genentech 包装标签图，只帮助核对品牌、通用名、标示强度、胶囊和来源；不用于鉴定真伪，也不证明 30 mg/45 mg、口服混悬剂、其他包装、其他市场标签、当前包装、原研身份、目标市场批准或可售资格。", "source": { "id": "src_5e49cf1bebe9cd67", "label": "DailyMed（NLM）：TAMIFLU 当前公开标签（Genentech；SPL v45，2025-12-19 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ee3c9555-60f2-4f82-a760-11983c86e97b", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "TAMIFLU 说明书放大阅读：胶囊与口服混悬剂不能只按“都是奥司他韦”互换", "en": "TAMIFLU label reading: capsules and oral suspension are not interchangeable simply because both contain oseltamivir" }, "summary": { "zh": "本模块以 DailyMed 2025 当前美国公开标签为阅读入口，帮助核对 TAMIFLU、奥司他韦、胶囊或复溶后口服混悬液、每个单位的标示强度/浓度和目标市场；它不把包装数字换算为个人的服用数量、补服方案或处方。", "en": "This module uses the current 2025 U.S. DailyMed public label as a reading entry point. It helps check TAMIFLU, oseltamivir, capsule or reconstituted oral suspension, labelled strength/concentration and target market; it does not convert package numbers into an individual's amount, make-up plan or prescription." }, "checks": [ { "zh": "先把商品名、通用名、剂型和规格放在一起看。胶囊上的 mg 与混悬液的浓度、量具和体积不是同一种信息；不能因都写奥司他韦，便自行把“几粒”改成“几毫升”或反向换算。", "en": "Read brand, generic name, dosage form and strength together. Milligrams on a capsule and the concentration, measuring device and volume of a suspension are not the same information; sharing oseltamivir does not permit self-conversion from “capsules” to “millilitres” or back." }, { "zh": "流感样症状、年龄、体重、肾功能、起病时间、实际产品及当地标签都会影响专业人员怎样核对处方。网页不判断是否应开始、何时开始、是否补用或能否把家中余药给另一位家人。", "en": "Flu-like symptoms, age, weight, kidney function, time since symptoms began, the actual product and local label all affect how professionals review a prescription. This page does not decide whether or when to start, make up a use, or give leftover medicine to another family member." }, { "zh": "TAMIFLU 是抗流感病毒产品的身份信息，不表示对普通感冒、细菌感染或所有发热咳嗽都能自行替代抗生素或其他药。合并的退烧、止咳、感冒、慢病和补充剂应作为完整药单交由药师或开方团队核对。", "en": "TAMIFLU identifies an influenza antiviral product; it does not establish that a common cold, bacterial infection or every fever and cough can be self-managed by replacing an antibiotic or another medicine. Fever, cough/cold, chronic-care and supplement products should be reviewed together as a complete medicine list." }, { "zh": "出现呼吸困难、意识改变、无法进食饮水、持续恶化，或对剂型、量具和标签不确定时，应及时使用当地医疗与专业支持渠道；本页不替代急性病情评估。", "en": "With breathing difficulty, altered awareness, inability to eat or drink, continued deterioration, or uncertainty about dosage form, measuring device or label, use timely local medical and professional support; this page does not replace assessment of acute illness." } ], "source": { "id": "src_5e49cf1bebe9cd67", "label": "DailyMed（NLM）：TAMIFLU 当前公开标签（Genentech；SPL v45，2025-12-19 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ee3c9555-60f2-4f82-a760-11983c86e97b", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "奥司他韦怎样起作用：它抑制流感病毒的神经氨酸酶", "en": "How oseltamivir works: it inhibits influenza-virus neuraminidase" }, "summary": { "zh": "FDA 标签将奥司他韦描述为流感病毒神经氨酸酶抑制剂；这一机制帮助解释它为什么属于抗流感病毒产品。它不诊断流感、不判断何时开始、不给出个人剂量，也不把它变成针对细菌感染或普通感冒的替代品。", "en": "The FDA label describes oseltamivir as an influenza-virus neuraminidase inhibitor; this helps explain why it is an influenza antiviral product. It does not diagnose influenza, decide when to start, give an individual dose, or turn it into a substitute for bacterial infection or the common cold." }, "checks": [ { "zh": "“抑制神经氨酸酶”是解释病毒传播相关路径的机制词，不是任何发热、咳嗽或接触史下自行用药的指令。是否适用及如何使用仍需依据准确产品的现行标签、病情评估和处方团队。", "en": "“Inhibiting neuraminidase” describes a pathway related to viral spread; it is not an instruction for self-use with every fever, cough or exposure history. Suitability and use still require the current label for the exact product, clinical assessment and the prescribing team." }, { "zh": "该机制不使 TAMIFLU 与抗生素、其他抗病毒药、退烧药或感冒复方药可自行叠加、替换或按名称判断安全。多药情境应让药师或医生核对完整药单与实际产品。", "en": "This mechanism does not make TAMIFLU self-combinable, substitutable or automatically safe with antibiotics, other antivirals, fever medicines or multi-ingredient cold products. In a multiple-medicine situation, have a pharmacist or clinician review the complete list and actual products." }, { "zh": "胶囊与口服混悬剂的区别属于产品身份和制剂信息，不会因机制相同就能相互换算。任何关于毫升、量具、胶囊数量、漏用或余药的疑问都应回到产品标签与专业人员。", "en": "The difference between a capsule and oral suspension is product-identity and formulation information; a shared mechanism does not make them convertible. Questions about millilitres, measuring devices, capsule count, missed use or leftover medicine must return to the product label and professionals." } ], "source": { "id": "src_5e49cf1bebe9cd67", "label": "DailyMed（NLM）：TAMIFLU 当前公开标签（Genentech；临床药理；SPL v45，2025-12-19 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ee3c9555-60f2-4f82-a760-11983c86e97b", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "Tamiflu", "generic": "奥司他韦", "dosageFormClass": "口服胶囊；口服混悬液用粉末（复溶后）（DailyMed 2025 标签所列）" }, "labelSource": { "id": "src_5e49cf1bebe9cd67", "label": "DailyMed（NLM）：TAMIFLU 当前公开标签（Genentech；SPL v45，2025-12-19 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ee3c9555-60f2-4f82-a760-11983c86e97b", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "productRoutes": [ { "source": { "id": "src_5e49cf1bebe9cd67", "label": "DailyMed（NLM）：TAMIFLU 当前公开标签（Genentech；SPL v45，2025-12-19 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ee3c9555-60f2-4f82-a760-11983c86e97b", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_cfab00b9ba7c705d", "label": "FDA：TAMIFLU 2019-08 美国历史标签（NDA 021087 / 021246）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021087s071%2C021246s054lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "Genentech 的 DailyMed TAMIFLU（oseltamivir phosphate）当前美国公开标签列示口服胶囊与口服混悬液用粉末（复溶后），并标示美国初始批准年份为 1999。本页分别记录一个 75 mg 胶囊泡罩卡面板与一个 6 mg/mL、60 mL 复溶后口服混悬液瓶装面板；不据此推定其他规格、其他市场批准、原研关系、供应或可售资格。", "history": "胶囊的 mg 与复溶后混悬液的 mg/mL 是不同的标签身份字段。共同品牌、共同成分或相近数字均不产生自行换算、配制、换药、补用或购买结论。", "sourceDocuments": [ { "id": "src_5e49cf1bebe9cd67", "label": "DailyMed（NLM）：TAMIFLU 当前公开标签（Genentech；SPL v45，2025-12-19 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ee3c9555-60f2-4f82-a760-11983c86e97b", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_cfab00b9ba7c705d", "label": "FDA：TAMIFLU 2019-08 美国历史标签（NDA 021087 / 021246）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021087s071%2C021246s054lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_5ed30b676fbb9773", "label": "FDA Drugs@FDA 官方检索入口", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_lookup_entry", "documentKind": "regulatory_lookup", "market": "US", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } ], "applicationNumber": "NDA 021087 / 021246", "approvalTimeline": [ { "date": "1999", "title": { "zh": "FDA 标签所列美国初始批准年份", "en": "Initial U.S. approval year listed in the FDA label" }, "detail": { "zh": "本页链接的 FDA 标签档案列示 Initial U.S. Approval: 1999。该历史定位不等同于当前批准、可得性、持有人或其他市场状态。", "en": "The FDA label archive linked here lists Initial U.S. Approval: 1999. This historical locator is not a conclusion about current approval, availability, holder or another market." }, "source": { "id": "src_5e49cf1bebe9cd67", "label": "DailyMed: TAMIFLU current public label", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ee3c9555-60f2-4f82-a760-11983c86e97b", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, { "date": "DailyMed SPL v45, 2025-12-19", "title": { "zh": "FDA 标签档案版本", "en": "FDA label archive version" }, "detail": { "zh": "本页链接 DailyMed SPL v45, 2025-12-19 的 FDA 标签档案作为可复核阅读入口。现行标签、规格、适应症和安全信息必须另行以目标市场当前文件核对。", "en": "This page links the DailyMed SPL v45, 2025-12-19 FDA label archive as a traceable reading entry point. Current labeling, strength, indication and safety information require separate verification against the target market’s current document." }, "source": { "id": "src_5e49cf1bebe9cd67", "label": "DailyMed: TAMIFLU current public label", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ee3c9555-60f2-4f82-a760-11983c86e97b", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "已链接公开标签档案", "en": "Public label archive linked" }, "detail": { "zh": "仅对应本页所列 FDA 文件。", "en": "Only the FDA document listed on this page is linked." } }, { "market": { "zh": "中国大陆、欧盟、日本", "en": "Mainland China, EU, Japan" }, "status": { "zh": "待逐项建立市场记录", "en": "Market record not established" }, "detail": { "zh": "不从美国标签档案推定当地批准、持有人、规格、供应或可售资格。", "en": "No local approval, holder, strength, supply or sale-eligibility conclusion is inferred from the U.S. label archive." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "标签档案能代表现在的产品信息吗？", "en": "Does a label archive represent current product information?" }, "answer": { "zh": "不能自动代表。档案用于定位来源；需要以目标市场的现行官方标签逐项复核。", "en": "Not automatically. The archive locates a source; each point needs verification against the target market’s current official label." } }, { "question": { "zh": "为什么这里不展示价格或原研/仿制结论？", "en": "Why are price and originator/generic conclusions not shown?" }, "answer": { "zh": "这些结论需要产品、剂型、规格、包装、市场、日期和原始记录分别齐全并经人工审核；单一标签文件不足以支持。", "en": "Those conclusions require separately complete and human-reviewed product, dosage-form, strength, pack, market, date and primary-record fields; one label file is insufficient." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "how-to-read-a-drug-label", "regulatory-sources-first" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/tamiflu/", "en": "https://origindrug.com/en/drugs/tamiflu/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "paxlovid", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-20", "status": "published_traceable_archive" }, "names": { "brand": "PAXLOVID", "generic": "奈玛特韦/利托那韦", "aliases": [ "PAXLOVID", "nirmatrelvir and ritonavir", "nirmatrelvir/ritonavir", "奈玛特韦/利托那韦", "奈玛特韦利托那韦" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "感染", "sourceArchiveMarket": "美国 PAXLOVID 奈玛特韦/利托那韦联装口服片公开标签（DailyMed SPL v12，2026-02-23 发布）", "dosageFormClass": "奈玛特韦片与利托那韦片联装口服片（美国公开标签所列）", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "2023（当前美国标签所列 Initial U.S. Approval）", "archiveSponsorText": "Pfizer Laboratories Div Pfizer Inc / DailyMed（NLM）当前公开标签档案" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-paxlovid-co-pack-300mg-100mg-3-tablet-blister-ndc-0069-5045-06", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v12，2026-02-23 发布", "en": "DailyMed SPL v12, published 23 Feb 2026" }, "dosageForm": { "zh": "PAXLOVID 奈玛特韦片与利托那韦片联装口服片", "en": "PAXLOVID nirmatrelvir tablets and ritonavir tablets, co-packaged for oral use" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 0069-5045-06", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_component_tablet", "primaryDisplay": { "zh": "奈玛特韦 150 mg × 2 + 利托那韦 100 mg × 1；3 片泡罩卡", "en": "Nirmatrelvir 150 mg × 2 + ritonavir 100 mg × 1; 3-tablet blister card" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=8a99d6d6-fd9e-45bb-b1bf-48c7f761232a&name=paxlovid-14.jpg", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "奈玛特韦", "en": "nirmatrelvir" }, "value": 150, "unit": "mg", "basisCode": "per_component_tablet", "basisLabel": { "zh": "每一奈玛特韦片的标签量；不是个人片数或使用方案", "en": "labelled amount in each nirmatrelvir tablet; not an individual's tablet count or use plan" } }, { "ingredient": { "zh": "利托那韦", "en": "ritonavir" }, "value": 100, "unit": "mg", "basisCode": "per_component_tablet", "basisLabel": { "zh": "每一利托那韦片的标签量；不是个人片数或使用方案", "en": "labelled amount in each ritonavir tablet; not an individual's tablet count or use plan" } } ], "concentration": null, "container": { "typeCode": "blister_card", "typeLabel": { "zh": "泡罩卡", "en": "blister card" }, "fill": null, "countPerPackage": 1, "countUnit": { "zh": "泡罩卡/包", "en": "blister card per pack" }, "unitsPerContainer": { "count": 3, "unit": { "zh": "片/泡罩卡", "en": "tablets per blister card" } } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": null, "package": { "count": 1, "unit": { "zh": "泡罩卡/包", "en": "blister card per pack" } }, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_c0ec17508cf85a14", "label": "DailyMed（NLM）：PAXLOVID 奈玛特韦/利托那韦联装口服片当前美国公开标签（Pfizer；SPL v12，2026-02-23 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8a99d6d6-fd9e-45bb-b1bf-48c7f761232a", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-paxlovid-co-pack-300mg-100mg-3-tablet-blister-ndc-0069-5045-06", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=8a99d6d6-fd9e-45bb-b1bf-48c7f761232a&name=paxlovid-14.jpg", "alt": "PAXLOVID 奈玛特韦/利托那韦在美国 DailyMed 当前公开标签中的 300 mg；100 mg 联装口服片 NDC 0069-5045-06 包装展示面", "archiveMarket": "美国", "labelVersion": "DailyMed SPL v12（2026-02-23 发布）", "presentation": "PAXLOVID 奈玛特韦片/利托那韦片联装口服片：300 mg；100 mg，NDC 0069-5045-06 包装展示面。", "notice": "此图只对应美国 DailyMed 当前公开标签中的 PAXLOVID 奈玛特韦片/利托那韦片联装口服片、300 mg；100 mg、NDC 0069-5045-06 包装展示面。包装面板保留原始标签文字，但本页不把它转成个人服用次数、片数、肾功能方案、联用、停用、补用、转换或其他市场结论；它不代表其他包装、其他肾功能包装、其他市场、实际可得性、原研身份或可替代性，也不用于鉴定真伪。", "source": { "id": "src_c0ec17508cf85a14", "label": "DailyMed（NLM）：PAXLOVID 奈玛特韦/利托那韦联装口服片当前美国公开标签（Pfizer；SPL v12，2026-02-23 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8a99d6d6-fd9e-45bb-b1bf-48c7f761232a", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "PAXLOVID 说明书放大阅读：先把两种成分、联装包装和完整药单一起核对", "en": "PAXLOVID label reading: check both ingredients, the co-packaged product and the complete medicine list together" }, "summary": { "zh": "本模块以美国 DailyMed 当前公开标签为阅读入口，帮助核对 PAXLOVID、奈玛特韦/利托那韦、联装口服片、准确包装面板和目标市场。它不提供个人片数、开始时间、肾功能方案、漏用补救、联用、停用或换药方案。", "en": "This module uses the current U.S. DailyMed public label to check PAXLOVID, nirmatrelvir/ritonavir, the co-packaged oral tablets, the exact package panel and target market. It provides no individual tablet count, start time, renal plan, missed-use remedy, co-use, stopping or switching plan." }, "checks": [ { "zh": "PAXLOVID 是两种成分的联装产品。包装上的奈玛特韦和利托那韦名称、毫克数字或药片外观，都不是把其中一部分与家中另一盒药自行拆分、补齐、替代或调整的依据；应由药师或开方团队核对准确处方、实际包装和现行标签。", "en": "PAXLOVID is a co-packaged two-ingredient product. Component names, milligram markings or tablet appearance on the pack do not justify self-separating, making up, substituting or adjusting one part with another medicine at home; have the exact prescription, actual pack and current label reviewed by a pharmacist or prescribing team." }, { "zh": "本页图片只对应美国 NDC 0069-5045-06 的一个联装包装面板。标签还涉及不同肾功能情况下的产品信息；品牌相同、颜色相近或都写有奈玛特韦/利托那韦，不能证明两盒包装或其内容可自行互换。", "en": "The page image corresponds only to one U.S. co-packaged panel, NDC 0069-5045-06. The label also contains product information for different renal circumstances; the same brand, similar colour or nirmatrelvir/ritonavir wording does not establish that two packs or their contents can be self-interchanged." }, { "zh": "美国标签对显著药物相互作用设有醒目警示：PAXLOVID 中的利托那韦可强烈影响某些合并药物的暴露，可能造成严重、危及生命或致命事件。开始前及使用期间应让医生或药师逐项复核全部处方药、非处方药和草本/补充剂；不要因为网页、药盒或他人经验自行停掉、减量、加量或错开任何长期用药。", "en": "The U.S. label has a prominent warning about significant drug interactions: ritonavir in PAXLOVID can strongly alter exposure to certain co-medications and may lead to serious, life-threatening or fatal events. Before and during use, have a clinician or pharmacist review every prescription medicine, OTC product and herbal/supplement product item by item; do not self-stop, reduce, increase or separate any long-term medicine because of a webpage, package or another person's experience." }, { "zh": "出现呼吸困难、面部/口唇/舌部肿胀、吞咽困难、严重皮疹，或其他急性严重不适时，应立即使用当地紧急医疗支持。对 COVID-19 症状、适用性、开始时间、肾功能、肝功能或相互作用的判断，仍需由当地医疗团队根据准确诊断、检验与完整药单处理。", "en": "With breathing difficulty, swelling of the face/lips/tongue, difficulty swallowing, severe rash or another acute serious concern, use local emergency medical support immediately. Questions about COVID-19 symptoms, suitability, timing, kidney function, liver function or interactions still require the local care team to use the exact diagnosis, tests and complete medicine list." } ], "source": { "id": "src_c0ec17508cf85a14", "label": "DailyMed（NLM）：PAXLOVID 奈玛特韦/利托那韦联装口服片当前美国公开标签（Boxed Warning、Patient Counseling；Pfizer；SPL v12）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8a99d6d6-fd9e-45bb-b1bf-48c7f761232a", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "PAXLOVID 怎样起作用：两种成分在联装产品中承担不同标签角色", "en": "How PAXLOVID works: the two ingredients have different labelled roles in one co-packaged product" }, "summary": { "zh": "美国 PAXLOVID 标签将奈玛特韦描述为针对 SARS-CoV-2 主蛋白酶的抑制剂，将利托那韦描述为 HIV-1 蛋白酶抑制剂和 CYP3A 抑制剂。它解释的是公开标签中的药理路径，不判断任何人的感染、风险、适用性、服用安排或与其他药物同用的结果。", "en": "The U.S. PAXLOVID label describes nirmatrelvir as an inhibitor of the SARS-CoV-2 main protease and ritonavir as an HIV-1 protease inhibitor and CYP3A inhibitor. This explains labelled pharmacologic pathways; it does not decide anyone's infection, risk, suitability, use arrangement or outcome with another medicine." }, "checks": [ { "zh": "“作用于病毒蛋白酶”不能用来从网页判断某个人是否需要抗病毒治疗、是否为 COVID-19、症状是否会自行好转，或何时开始任何产品。诊断、检测和时效判断应由当地医疗渠道完成。", "en": "“Acts on a viral protease” cannot be used by a webpage to decide whether a person needs antiviral treatment, has COVID-19, will improve on their own or should start any product at a particular time. Diagnosis, testing and time-sensitive assessment belong with local medical care." }, { "zh": "利托那韦的 CYP3A 抑制作用也是为什么完整药单很重要：机制词不能告诉网页某一种降压药、降脂药、抗凝药、镇静药、草本或补充剂是否应停、减、换或错开。任何这类决定都必须由熟悉准确处方和全部产品的人作出。", "en": "Ritonavir's CYP3A inhibition is also why the complete medicine list matters: a mechanism term cannot tell a webpage whether a blood-pressure medicine, lipid medicine, anticoagulant, sedative, herb or supplement should be stopped, reduced, changed or separated. Such decisions must be made by someone reviewing the exact prescription and every product." }, { "zh": "共同出现在 PAXLOVID 标签中不使奈玛特韦、利托那韦或其他含利托那韦产品可自行混用；共同成分、相近包装数字或过去的处方经历都不能替代这一准确联装产品和现行标签的专业核对。", "en": "Appearing together on the PAXLOVID label does not make nirmatrelvir, ritonavir or another ritonavir-containing product self-combinable. A shared ingredient, similar package number or past prescription experience cannot replace professional review of this exact co-packaged product and current label." } ], "source": { "id": "src_c0ec17508cf85a14", "label": "DailyMed（NLM）：PAXLOVID 奈玛特韦/利托那韦联装口服片当前美国公开标签（Clinical Pharmacology；Pfizer；SPL v12）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8a99d6d6-fd9e-45bb-b1bf-48c7f761232a", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "PAXLOVID", "generic": "奈玛特韦/利托那韦", "dosageFormClass": "奈玛特韦片与利托那韦片联装口服片（美国公开标签所列）" }, "labelSource": { "id": "src_c0ec17508cf85a14", "label": "DailyMed（NLM）：PAXLOVID 奈玛特韦/利托那韦联装口服片当前美国公开标签（Pfizer；SPL v12，2026-02-23 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8a99d6d6-fd9e-45bb-b1bf-48c7f761232a", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "productRoutes": [ { "source": { "id": "src_c0ec17508cf85a14", "label": "DailyMed（NLM）：PAXLOVID 奈玛特韦/利托那韦联装口服片当前美国公开标签（Pfizer；SPL v12，2026-02-23 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8a99d6d6-fd9e-45bb-b1bf-48c7f761232a", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [ { "id": "fda-2024-paxlovid-eua-labelled-product-transition-alert", "issuedAt": "2024-03-13", "status": "fda_drug_alert_product_status_transition", "title": { "zh": "FDA 药品警示：美国 EUA 标签 PAXLOVID 的授权状态变化", "en": "FDA drug alert: U.S. authorisation-status change for EUA-labelled PAXLOVID" }, "summary": { "zh": "FDA 于 2024-03-13 更新公告，说明在美国市场，带 EUA 标签的 PAXLOVID（包括标签或延长有效期信息仍在的产品）不再获紧急使用授权；公告要求美国流通中的该类 EUA 标签产品按适用规定退回或处置，同时区分 NDA 批准标签产品。这是美国、特定标签状态和特定日期的监管信息；它不判断其他市场、任何药盒真伪、个人是否应使用 PAXLOVID，或能否自行改变联用药物。请以实际药盒、所在市场的现行文件和开方/药师核对为准。", "en": "In an update dated 2024-03-13, FDA said that in the U.S. PAXLOVID labelled for EUA use, including product whose labelled or extended expiration information remained, was no longer authorised for emergency use; the notice directs handling of EUA-labelled product in U.S. distribution and distinguishes NDA-approved labelling. This is U.S.-market information for a specific labelling status and date. It does not determine another market, authenticity of any pack, whether an individual should use PAXLOVID, or whether co-medication can be changed independently. Check the actual pack, the current document for its market and the prescribing team or pharmacist." }, "source": { "id": "src_e56ae8bf3217e8db", "label": "FDA：2024-03-13 EUA 标签 PAXLOVID 授权状态更新", "url": "https://www.fda.gov/drugs/drug-alerts-and-statements/fda-revises-letter-authorization-emergency-use-authorization-paxlovid", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "美国 DailyMed 的 PAXLOVID 公开标签将其列为奈玛特韦片与利托那韦片联装口服产品。本页只帮助核对品牌、两种成分、联装口服片、准确包装面板、目标市场和标签版本；不把包装图中的数字或原始说明转成任何人的服用次数、片数、肾功能方案、联用、停用、转换或购买建议。", "history": "当前公开标签列示 Initial U.S. Approval: 2023。PAXLOVID 是包含两种成分的联装产品；不能因看到其中任一成分名称、相近毫克数字或另一盒利托那韦产品，就自行拆分、补齐、合并、替换或调整。", "sourceDocuments": [ { "id": "src_c0ec17508cf85a14", "label": "DailyMed（NLM）：PAXLOVID 奈玛特韦/利托那韦联装口服片当前美国公开标签（Pfizer；SPL v12，2026-02-23 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8a99d6d6-fd9e-45bb-b1bf-48c7f761232a", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } ], "applicationNumber": "NDA 217188", "approvalTimeline": [ { "date": "2023", "title": { "zh": "当前标签所列美国初始批准年份", "en": "Initial U.S. approval year listed in the current label" }, "detail": { "zh": "当前 PAXLOVID 标签列示 Initial U.S. Approval: 2023。该年份仅定位这一美国档案，不建立中国大陆、欧盟、日本或其他市场的批准、供应、可售资格或个人适用性。", "en": "The current PAXLOVID label lists Initial U.S. Approval: 2023. This year locates this U.S. archive only; it does not establish approval, supply, sale eligibility or individual suitability in Mainland China, the EU, Japan or another market." }, "source": { "id": "src_c0ec17508cf85a14", "label": "DailyMed（NLM）：PAXLOVID 奈玛特韦/利托那韦联装口服片当前美国公开标签（Pfizer；SPL v12，2026-02-23 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8a99d6d6-fd9e-45bb-b1bf-48c7f761232a", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, { "date": "2026-02-23", "title": { "zh": "DailyMed 当前公开 SPL v12", "en": "Current public SPL v12 published on DailyMed" }, "detail": { "zh": "DailyMed 将该 PAXLOVID 联装口服片 SPL v12 的发布日期列为 2026-02-23。本页只选取一个准确 300 mg；100 mg、NDC 0069-5045-06 包装面板，不能据此推定其他包装、肾功能包装、库存、开始时间、联用或个人用法。", "en": "DailyMed lists 23 Feb 2026 as the publication date for PAXLOVID co-packaged oral-tablet SPL v12. This page selects only one exact 300 mg; 100 mg package panel, NDC 0069-5045-06, and does not establish another pack, a renal-related pack, stock, start time, co-use or individual use." }, "source": { "id": "src_c0ec17508cf85a14", "label": "DailyMed（NLM）：PAXLOVID 奈玛特韦/利托那韦联装口服片当前美国公开标签（Pfizer；SPL v12，2026-02-23 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8a99d6d6-fd9e-45bb-b1bf-48c7f761232a", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "已链接联装口服片公开标签与一个准确包装面板", "en": "Co-packaged oral-tablet public label and one exact package panel linked" }, "detail": { "zh": "本页展示的面板只对应 PAXLOVID 奈玛特韦片/利托那韦片联装口服片、300 mg；100 mg、NDC 0069-5045-06。它不建立实际在售、库存、个人用法、肾功能方案、联用、停用、补用或其他包装状态。", "en": "The displayed panel only corresponds to PAXLOVID nirmatrelvir/ritonavir co-packaged oral tablets, 300 mg; 100 mg, NDC 0069-5045-06. It does not establish actual availability, stock, individual use, a renal plan, co-use, stopping, make-up use or another-pack status." } }, { "market": { "zh": "中国大陆、欧盟、日本及其他市场", "en": "Mainland China, EU, Japan and other markets" }, "status": { "zh": "待逐项建立市场记录", "en": "Market record not established" }, "detail": { "zh": "不从美国标签或品牌名称推定当地商品名、批准、包装、供应、可售资格、原研/仿制关系或可替代性；任何市场版本均需按当地现行监管资料单独核对。", "en": "No local trade name, approval, packaging, supply, sale eligibility, originator/generic relationship or interchangeability is inferred from the U.S. label or brand name; every market version needs separate checking against current local regulatory information." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "包装上写着奈玛特韦和利托那韦，能否拿另一盒含其中一项成分的药来补、换或搭配？", "en": "The package names nirmatrelvir and ritonavir. Can another medicine containing one component be used to make up, replace or pair with it?" }, "answer": { "zh": "不能。本页只建立这一联装产品的美国公开标签阅读路径。共同成分、相近毫克数字或另一盒产品不能证明可自行补齐、拆分、合并、替换、错开或调整；应立即让药师或开方团队核对完整药单、实际包装和现行标签。", "en": "No. This page establishes only the U.S. public-label reading path for this co-packaged product. A shared component, similar milligram marking or another pack cannot establish self-make-up, separation, combination, replacement, spacing or adjustment; have a pharmacist or prescribing team promptly review the complete medicine list, actual pack and current label." } }, { "question": { "zh": "为什么在 PAXLOVID 页面反复要求核对全部药物、非处方药和草本/补充剂？", "en": "Why does the PAXLOVID page repeatedly ask for review of all medicines, OTC products and herbs/supplements?" }, "answer": { "zh": "因为当前美国标签对显著药物相互作用设有醒目警示，且利托那韦可强烈影响某些合并药物的暴露。这个提示不列出或决定任何个人该停、该改或该继续的产品；它的目的只是引导尽快进行逐项专业复核。", "en": "Because the current U.S. label has a prominent warning about significant drug interactions and ritonavir can strongly alter exposure to some co-medications. This prompt does not list or decide which product an individual should stop, change or continue; its purpose is to direct prompt item-by-item professional review." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "dosage-forms-are-part-of-medicine-identity", "how-to-read-a-drug-label" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/paxlovid/", "en": "https://origindrug.com/en/drugs/paxlovid/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "valtrex", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-23", "status": "published_traceable_archive" }, "names": { "brand": "Valtrex", "generic": "伐昔洛韦", "aliases": [ "valacyclovir" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "感染", "sourceArchiveMarket": "美国 DailyMed 公开标签（GSK，2025-11-12 更新）。本档案只建立标签明确列出的 VALTREX 500 mg（NDC 0173-0933-08）与 1 g（NDC 0173-0565-04）各 30 片瓶装身份；不从该资料推定中国大陆、欧盟、日本或其他市场的当前标签、批准、供应、可得性或可替代性。", "dosageFormClass": "伐昔洛韦盐酸盐薄膜衣口服片：500 mg、1 g（美国公开标签所列；各 30 片瓶装）", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "1995（美国公开标签所列初始批准）", "archiveSponsorText": "GlaxoSmithKline / DailyMed 美国公开标签" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-valtrex-valacyclovir-tablet-500mg-30-bottle-ndc-0173-0933-08", "marketCode": "US", "labelVersion": { "zh": "DailyMed 美国有日期公开标签（GSK，2025-11-12 更新）", "en": "DailyMed U.S. dated public label (GSK, updated 12 Nov 2025)" }, "dosageForm": { "zh": "VALTREX 伐昔洛韦盐酸盐薄膜衣口服片", "en": "VALTREX valacyclovir hydrochloride film-coated oral tablet" }, "route": { "zh": "口服（标签产品身份字段）", "en": "oral (label product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 0173-0933-08", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片 500 mg；30 片瓶装", "en": "500 mg per tablet; 30-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=valtrex-spl-graphic-02.jpg&setid=f8e0d8f8-cb73-4206-a484-88f5c4fbd719&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "伐昔洛韦", "en": "valacyclovir" }, "value": 500, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、剂量、分片、换算或换药指令", "en": "labelled amount per tablet; not an individual's tablet count, dose, splitting, conversion or switching instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "30 片瓶装", "en": "30-tablet bottle" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-23", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 30, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "蓝色", "en": "blue" }, "shape": { "zh": "胶囊形薄膜衣片；无刻痕，不是自行掰开指示", "en": "capsule-shaped film-coated tablet; unscored, not an instruction to split" }, "imprint": "VALTREX 500 mg", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_f50ac8695bc1a85d", "label": "DailyMed（NLM）：VALTREX 伐昔洛韦美国公开标签（GSK，2025-11-12 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=f8e0d8f8-cb73-4206-a484-88f5c4fbd719", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-valtrex-valacyclovir-tablet-1g-30-bottle-ndc-0173-0565-04", "marketCode": "US", "labelVersion": { "zh": "DailyMed 美国有日期公开标签（GSK，2025-11-12 更新）", "en": "DailyMed U.S. dated public label (GSK, updated 12 Nov 2025)" }, "dosageForm": { "zh": "VALTREX 伐昔洛韦盐酸盐薄膜衣口服片", "en": "VALTREX valacyclovir hydrochloride film-coated oral tablet" }, "route": { "zh": "口服（标签产品身份字段）", "en": "oral (label product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 0173-0565-04", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片 1 g；30 片瓶装", "en": "1 g per tablet; 30-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=valtrex-spl-graphic-03.jpg&setid=f8e0d8f8-cb73-4206-a484-88f5c4fbd719&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "伐昔洛韦", "en": "valacyclovir" }, "value": 1000, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、剂量、分片、换算或换药指令", "en": "labelled amount per tablet; not an individual's tablet count, dose, splitting, conversion or switching instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "30 片瓶装", "en": "30-tablet bottle" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-23", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 30, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "蓝色", "en": "blue" }, "shape": { "zh": "胶囊形薄膜衣片；两面均有部分刻痕外观，不能据此自行掰片", "en": "capsule-shaped film-coated tablet; partial scorebar on both sides, not an instruction to self-split" }, "imprint": "VALTREX 1 gram", "scoreStatus": "scored_status_not_a_split_instruction", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_f50ac8695bc1a85d", "label": "DailyMed（NLM）：VALTREX 伐昔洛韦美国公开标签（GSK，2025-11-12 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=f8e0d8f8-cb73-4206-a484-88f5c4fbd719", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-valtrex-valacyclovir-tablet-500mg-30-bottle-ndc-0173-0933-08", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=valtrex-spl-graphic-02.jpg&setid=f8e0d8f8-cb73-4206-a484-88f5c4fbd719&type=img", "alt": "VALTREX 500 mg 伐昔洛韦片在美国 DailyMed 公开标签中的 GSK 30 片装包装标签图", "archiveMarket": "美国", "labelVersion": "DailyMed 美国公开标签（GSK，2025-11-12 更新；包装图稿 2023-03）", "presentation": "VALTREX 500 mg、30 片装包装标签图（DailyMed 公开标签所列；GSK 标签图）。", "notice": "此为美国 DailyMed 公开标签中明确对应 VALTREX 500 mg、30 片装的 GSK 包装标签图，只帮助核对品牌、通用名、标示强度、片剂和来源；不用于鉴定真伪，也不证明 1 g、其他包装、其他市场标签、当前包装、原研身份、目标市场批准或可售资格。", "source": { "id": "src_f50ac8695bc1a85d", "label": "DailyMed（NLM）：VALTREX 伐昔洛韦美国公开标签（GSK，2025-11-12 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=f8e0d8f8-cb73-4206-a484-88f5c4fbd719", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "VALTREX 说明书放大阅读：商品名、片剂强度和疾病情境必须一起核对", "en": "VALTREX label reading: brand, tablet strength and clinical context must be checked together" }, "summary": { "zh": "本模块以 DailyMed 2025-11-12 美国公开标签为阅读入口，帮助核对 VALTREX、伐昔洛韦、500 mg 或 1 g 口服片、准确 NDC、30 片瓶装和目标市场；它不判断个人该服几片、开始时机、是否能分片或能否把另一种抗病毒药换过来。", "en": "This module uses the DailyMed U.S. public label updated 12 Nov 2025 as a reading entry point. It helps check VALTREX, valacyclovir, 500 mg or 1 g oral tablets, the exact NDC, a 30-tablet bottle and target market; it does not decide an individual's tablet count, starting time, splitting, or a change from another antiviral product." }, "checks": [ { "zh": "“同为抗病毒药”“都是疱疹相关”或相近的 mg 数字，都不是可自行替代、交替或合并的证明。应同时核对商品名、通用名、准确片剂强度、适用情形、肾功能相关信息和目标市场标签。", "en": "“Both antiviral,” “both herpes-related” or a nearby mg number does not prove that products can be self-substituted, alternated or combined. Check brand, generic name, exact tablet strength, use context, kidney-related information and the target-market label together." }, { "zh": "片剂上的 mg 首先是每片的标示强度，并不是通用的“每天吃几片”答案。是否能分片、漏用后怎样处理、是否换另一种剂型或药物，必须由准确产品的现行标签和药师/开方团队确认。", "en": "The mg on a tablet is first the labelled strength per tablet; it is not a general answer to “how many tablets a day.” Splitting, handling a missed use, or changing to another dosage form or medicine must be confirmed from the current label for the exact product and a pharmacist/prescribing team." }, { "zh": "高龄、肾功能变化、脱水、多药并用或出现新的神经系统症状时，不能用网页自行加减或延长疗程。把所有处方药、非处方药、草本和实际包装一起交由专业人员核对。", "en": "With older age, changing kidney function, dehydration, multiple medicines or new neurologic symptoms, do not self-adjust or extend treatment from a webpage. Take every prescription, OTC product, herb and actual package together for professional review." }, { "zh": "药盒外观和网页的来源链接仅用于确认阅读对象，不能鉴定真伪、决定适用性或替代当地医疗评估。出现严重不适、皮疹伴全身症状或不确定如何使用时，应及时走当地医疗支持渠道。", "en": "Package appearance and a webpage source link only identify the item being read; they cannot authenticate a medicine, decide suitability or replace local medical assessment. With severe illness, rash with systemic symptoms or uncertainty about use, seek timely local medical support." } ], "source": { "id": "src_f50ac8695bc1a85d", "label": "DailyMed（NLM）：VALTREX 伐昔洛韦美国公开标签（GSK，2025-11-12 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=f8e0d8f8-cb73-4206-a484-88f5c4fbd719", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "伐昔洛韦怎样起作用：它在体内转化为阿昔洛韦并影响病毒 DNA 聚合酶", "en": "How valacyclovir works: it converts to acyclovir and affects viral DNA polymerase" }, "summary": { "zh": "DailyMed 美国公开标签说明伐昔洛韦在体内迅速转化为阿昔洛韦；后者经病毒相关过程活化并抑制疱疹病毒 DNA 聚合酶。该机制只帮助理解药物类别和为何产品转换需要核对，不判断个人的诊断、疗程、强度或是否适合使用。", "en": "The U.S. DailyMed public label explains that valacyclovir is rapidly converted to acyclovir; acyclovir is activated through virus-related processes and inhibits herpes-virus DNA polymerase. This only helps explain drug class and why product changes need review; it does not determine an individual's diagnosis, duration, strength or suitability." }, "checks": [ { "zh": "“转化为阿昔洛韦”不表示 VALTREX 与阿昔洛韦或其他抗病毒药可按名字、片数或 mg 自行换算。不同产品、剂型、强度、市场标签和个人情况必须逐项核对。", "en": "“Converts to acyclovir” does not mean VALTREX and acyclovir or another antiviral can be self-converted by name, tablet count or mg. Different products, dosage forms, strengths, market labels and individual factors must be checked item by item." }, { "zh": "机制不替代对肾功能、脱水、年龄、联用药物、皮疹或神经系统症状的临床判断。出现新问题或想延长、减少、漏用后补用时，应联系专业人员而不是从机制推导做法。", "en": "Mechanism does not replace clinical judgment about kidney function, dehydration, age, co-medications, rash or neurologic symptoms. With a new concern or a wish to extend, reduce or make up use, contact professionals rather than derive a plan from mechanism." }, { "zh": "相同疾病名称、相近药理或网上的包装图片，都不能证明一件药适合另一位家庭成员。每位使用者的实际包装、处方和病情需要独立复核。", "en": "The same disease name, a related pharmacology or an online package image cannot prove that one medicine suits another family member. Each person's actual package, prescription and condition need independent review." } ], "source": { "id": "src_f50ac8695bc1a85d", "label": "DailyMed（NLM）：VALTREX 伐昔洛韦美国公开标签（GSK；临床药理；2025-11-12 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=f8e0d8f8-cb73-4206-a484-88f5c4fbd719", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "Valtrex", "generic": "伐昔洛韦", "dosageFormClass": "伐昔洛韦盐酸盐薄膜衣口服片：500 mg、1 g（美国公开标签所列；各 30 片瓶装）" }, "labelSource": { "id": "src_f50ac8695bc1a85d", "label": "DailyMed（NLM）：VALTREX 伐昔洛韦美国公开标签（GSK，2025-11-12 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=f8e0d8f8-cb73-4206-a484-88f5c4fbd719", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "productRoutes": [ { "source": { "id": "src_f50ac8695bc1a85d", "label": "DailyMed（NLM）：VALTREX 伐昔洛韦美国公开标签（GSK，2025-11-12 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=f8e0d8f8-cb73-4206-a484-88f5c4fbd719", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-23", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-23", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "DailyMed 的 VALTREX（valacyclovir）美国公开标签列出 500 mg 与 1 g 薄膜衣口服片，并各有一项 30 片瓶装 NDC。本页把商品名、通用名、每片标示量、准确 NDC、包装、说明书和药物警戒入口放在一起阅读；数字只用于药盒身份核对，不转换为个人片数、开始、停用、联用、分片、换药或购买结论。", "history": "该美国公开标签列示 Initial U.S. Approval: 1995，并在 2025-11-12 更新。500 mg 片标有 VALTREX 500 mg；1 g 片标有 VALTREX 1 gram，且外观写有两面部分刻痕。刻痕属于标签外观线索，不是自行掰片许可；片数、分片、漏用、转换或与其他抗病毒药同用须按实际产品、目标市场现行标签和药师或开方团队逐项确认。", "sourceDocuments": [ { "id": "src_f50ac8695bc1a85d", "label": "DailyMed（NLM）：VALTREX 伐昔洛韦美国公开标签（GSK，2025-11-12 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=f8e0d8f8-cb73-4206-a484-88f5c4fbd719", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, { "id": "src_5ed30b676fbb9773", "label": "FDA Drugs@FDA 官方检索入口", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_lookup_entry", "documentKind": "regulatory_lookup", "market": "US", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } ], "applicationNumber": "NDA 020487", "approvalTimeline": [ { "date": "1995", "title": { "zh": "FDA 标签所列美国初始批准年份", "en": "Initial U.S. approval year listed in the FDA label" }, "detail": { "zh": "本页链接的 FDA 标签档案列示 Initial U.S. Approval: 1995。该历史定位不等同于当前批准、可得性、持有人或其他市场状态。", "en": "The FDA label archive linked here lists Initial U.S. Approval: 1995. This historical locator is not a conclusion about current approval, availability, holder or another market." }, "source": { "id": "src_f50ac8695bc1a85d", "label": "DailyMed: VALTREX valacyclovir U.S. public label (GSK; updated 2025-11-12)", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=f8e0d8f8-cb73-4206-a484-88f5c4fbd719", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" } }, { "date": "2025-11-12", "title": { "zh": "FDA 标签档案版本", "en": "FDA label archive version" }, "detail": { "zh": "本页链接 2025-11-12 的 FDA 标签档案作为可复核阅读入口。现行标签、规格、适应症和安全信息必须另行以目标市场当前文件核对。", "en": "This page links the 2025-11-12 FDA label archive as a traceable reading entry point. Current labeling, strength, indication and safety information require separate verification against the target market’s current document." }, "source": { "id": "src_f50ac8695bc1a85d", "label": "DailyMed: VALTREX valacyclovir U.S. public label (GSK; updated 2025-11-12)", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=f8e0d8f8-cb73-4206-a484-88f5c4fbd719", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "已链接公开标签档案", "en": "Public label archive linked" }, "detail": { "zh": "仅对应本页所列 FDA 文件。", "en": "Only the FDA document listed on this page is linked." } }, { "market": { "zh": "中国大陆、欧盟、日本", "en": "Mainland China, EU, Japan" }, "status": { "zh": "待逐项建立市场记录", "en": "Market record not established" }, "detail": { "zh": "不从美国标签档案推定当地批准、持有人、规格、供应或可售资格。", "en": "No local approval, holder, strength, supply or sale-eligibility conclusion is inferred from the U.S. label archive." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "标签档案能代表现在的产品信息吗？", "en": "Does a label archive represent current product information?" }, "answer": { "zh": "不能自动代表。档案用于定位来源；需要以目标市场的现行官方标签逐项复核。", "en": "Not automatically. The archive locates a source; each point needs verification against the target market’s current official label." } }, { "question": { "zh": "为什么这里不展示价格或原研/仿制结论？", "en": "Why are price and originator/generic conclusions not shown?" }, "answer": { "zh": "这些结论需要产品、剂型、规格、包装、市场、日期和原始记录分别齐全并经人工审核；单一标签文件不足以支持。", "en": "Those conclusions require separately complete and human-reviewed product, dosage-form, strength, pack, market, date and primary-record fields; one label file is insufficient." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "how-to-read-a-drug-label", "regulatory-sources-first" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/valtrex/", "en": "https://origindrug.com/en/drugs/valtrex/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "bactrim", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-21", "status": "published_traceable_archive" }, "names": { "brand": "Bactrim", "generic": "复方磺胺甲噁唑", "aliases": [ "sulfamethoxazole and trimethoprim", "sulfamethoxazole/trimethoprim", "sulfamethoxazole", "trimethoprim" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "感染", "sourceArchiveMarket": "美国公开监管标签档案", "dosageFormClass": "口服片剂：BACTRIM 400 mg/80 mg；BACTRIM DS 800 mg/160 mg（DailyMed 2024-12 公开标签所列）", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "美国初始批准年份待逐项核验", "archiveSponsorText": "Sun Pharmaceutical Industries, Inc. / DailyMed 公开监管标签档案" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-bactrim-ds-tablet-800mg-160mg-ndc-49708-146-01", "marketCode": "US", "labelVersion": { "zh": "DailyMed 公开标签，2024-12-30 更新；仅为所引公开标签展示面，不代表供应", "en": "DailyMed public label, updated 30 Dec 2024; cited label panel only, not availability" }, "dosageForm": { "zh": "BACTRIM DS 复方磺胺甲噁唑/甲氧苄啶口服片", "en": "BACTRIM DS sulfamethoxazole/trimethoprim oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 49708-146-01", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片磺胺甲噁唑 800 mg / 甲氧苄啶 160 mg；100 片瓶装", "en": "Sulfamethoxazole 800 mg / trimethoprim 160 mg per tablet; 100-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=Bactrim-05.jpg&setid=f59d0c04-9c66-4d53-a0e1-cb55570deb62&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "磺胺甲噁唑", "en": "sulfamethoxazole" }, "value": 800, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标示量；必须与甲氧苄啶一同核对，不是个人片数、疗程或自行换算", "en": "labelled amount per tablet; check together with trimethoprim, not an individual tablet count, course or self-conversion" } }, { "ingredient": { "zh": "甲氧苄啶", "en": "trimethoprim" }, "value": 160, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标示量；必须与磺胺甲噁唑一同核对，不是个人片数、疗程或自行换算", "en": "labelled amount per tablet; check together with sulfamethoxazole, not an individual tablet count, course or self-conversion" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-21", "currentLabelDisplayed": true, "ndcDirectoryListed": false, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_aa35f64fb63f1003", "label": "DailyMed（NLM）：BACTRIM DS 800 mg/160 mg、100 片瓶装（NDC 49708-146-01；Sun Pharmaceutical Industries；2024-12-30 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=f59d0c04-9c66-4d53-a0e1-cb55570deb62", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": null, "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=Bactrim-05.jpg&setid=f59d0c04-9c66-4d53-a0e1-cb55570deb62&type=img", "alt": "BACTRIM DS 800 mg/160 mg 复方磺胺甲噁唑片在美国 DailyMed 公开标签中的 Sun Pharma 100 片瓶装标签图", "archiveMarket": "美国", "labelVersion": "DailyMed 公开标签（Sun Pharmaceutical Industries, Inc.，2024-12 更新；图稿修订 2020-07）", "presentation": "BACTRIM DS 800 mg 磺胺甲噁唑/160 mg 甲氧苄啶、100 片瓶装标签图（NDC 49708-146-01；DailyMed 公开标签所列；Sun Pharma 标签图）。", "notice": "此为美国 DailyMed 公开标签中明确对应 BACTRIM DS 800 mg 磺胺甲噁唑/160 mg 甲氧苄啶、100 片瓶装（NDC 49708-146-01）的 Sun Pharma 标签图，只帮助核对品牌、两种通用名、每片标示强度、口服片、包装数量和来源；不用于鉴定真伪，也不证明 BACTRIM 400 mg/80 mg、静脉用制剂、其他包装、其他市场标签、当前包装、原研身份、目标市场批准或可售资格。", "source": { "id": "src_aa35f64fb63f1003", "label": "DailyMed（NLM）：BACTRIM / BACTRIM DS 公开标签（Sun Pharmaceutical Industries, Inc.，2024-12 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=f59d0c04-9c66-4d53-a0e1-cb55570deb62", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "BACTRIM 说明书放大阅读：400/80 与 DS 800/160 是两种成分、强度与包装的组合核对", "en": "BACTRIM label reading: 400/80 and DS 800/160 require joint checks of two ingredients, strength and pack" }, "summary": { "zh": "本模块以 Sun Pharmaceutical Industries, Inc. 的 DailyMed 2024-12 美国公开标签为阅读入口，严格对应 BACTRIM 400 mg 磺胺甲噁唑/80 mg 甲氧苄啶片，以及 BACTRIM DS 800 mg/160 mg 片。图示仅为 DS 800 mg/160 mg、100 片瓶装（NDC 49708-146-01）；不提供个人片数、疗程、补用、转换或与其他抗感染药联用的方案。", "en": "This module uses Sun Pharmaceutical Industries, Inc.'s Dec 2024 U.S. DailyMed public label as a reading entry point. It distinguishes BACTRIM 400 mg sulfamethoxazole/80 mg trimethoprim tablets from BACTRIM DS 800 mg/160 mg tablets. The visual is limited to the DS 800 mg/160 mg, 100-tablet bottle (NDC 49708-146-01); it does not provide an individual's tablet count, course, make-up, switching or combination plan with another anti-infective." }, "checks": [ { "zh": "“400 mg/80 mg”与“800 mg/160 mg”各自同时标示两种活性成分，不是一个可自行相加、拆分或换算的单一数字。DS（double strength）是该准确包装的产品身份词；不能因名称相同或数字成倍，就自行把常规片与 DS 片互换、拼量或补用。", "en": "“400 mg/80 mg” and “800 mg/160 mg” each label two active ingredients, not one number to self-add, split or convert. DS (double strength) is an identity term for the exact pack; the shared name or doubled numbers do not permit self-substitution, combining or make-up use between regular and DS tablets." }, { "zh": "图示的 NDC 49708-146-01、100 片与“BACTRIM DS 800 mg/160 mg”是同一美国瓶装的组合线索。包装数量不是疗程天数，包装外观也不能鉴定真伪或证明另一种包装、另一市场或另一剂型相同。", "en": "The pictured NDC 49708-146-01, 100-tablet count and “BACTRIM DS 800 mg/160 mg” are combined clues for one U.S. bottle. Pack count is not a course length, and appearance cannot authenticate a medicine or establish that another pack, market or dosage form is the same." }, { "zh": "本页对应口服片剂；它不能覆盖 BACTRIM 的静脉用历史标签或其他含磺胺甲噁唑/甲氧苄啶产品。即使通用名相同，也不能从口服片页面推导输注、转换、分装或其他给药途径的操作。", "en": "This page covers oral tablets; it does not cover BACTRIM's historical intravenous label or another sulfamethoxazole/trimethoprim product. Even with the same generic names, an oral-tablet page cannot derive infusion, conversion, division or another route of administration." }, { "zh": "该标签含严重皮肤反应、血液、肾脏、钾水平及多种联用相关警示。正在使用抗凝药、降糖药、利尿/降压药、甲氨蝶呤、补充剂或多种药物，或出现广泛皮疹、口腔/眼部黏膜问题、发热、明显乏力或其他严重不适时，应及时使用当地医疗支持并让专业人员核对完整药单；不要自行重复、叠加、停换或借用抗菌药。", "en": "The label includes warnings related to serious skin reactions, blood, kidney, potassium and multiple co-medications. With an anticoagulant, glucose-lowering medicine, diuretic/blood-pressure medicine, methotrexate, supplement or multiple medicines, or with widespread rash, mouth/eye mucosal problems, fever, marked weakness or another severe concern, use timely local medical support and have professionals review the complete list; do not self-repeat, combine, stop/switch or share an antibacterial." } ], "source": { "id": "src_aa35f64fb63f1003", "label": "DailyMed（NLM）：BACTRIM / BACTRIM DS 公开标签（Sun Pharmaceutical Industries, Inc.，2024-12 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=f59d0c04-9c66-4d53-a0e1-cb55570deb62", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "复方磺胺甲噁唑怎样起作用：两种成分连续阻断细菌叶酸合成路径", "en": "How sulfamethoxazole/trimethoprim works: two ingredients block consecutive steps in bacterial folate synthesis" }, "summary": { "zh": "DailyMed 的 BACTRIM 标签说明，磺胺甲噁唑与对氨基苯甲酸竞争，抑制细菌二氢叶酸合成；甲氧苄啶则可逆性抑制二氢叶酸还原酶，阻断四氢叶酸形成。它们作用于许多细菌核酸与蛋白质生物合成中的连续步骤。这个机制概述不诊断感染，也不决定个人是否需要抗菌药、选择哪种产品、强度、片数或疗程。", "en": "The BACTRIM DailyMed label explains that sulfamethoxazole competes with para-aminobenzoic acid to inhibit bacterial dihydrofolic-acid synthesis, while trimethoprim reversibly inhibits dihydrofolate reductase and blocks tetrahydrofolic-acid formation. They act at consecutive steps in nucleic-acid and protein biosynthesis in many bacteria. This overview does not diagnose an infection or decide whether an individual needs an antibacterial, which product to use, strength, tablet count or course." }, "checks": [ { "zh": "“双重阻断叶酸路径”是解释两种成分为何写在同一标签上的药理概念，不代表所有发热、咳嗽、腹泻、排尿不适、皮疹或其他症状都是细菌感染，更不表示都适合这一产品。原因、检测（如适用）、市场标签与专业评估必须分开核对。", "en": "“Two-step folate-pathway blockade” is a pharmacology concept explaining why two ingredients appear on one label. It does not mean every fever, cough, diarrhoea, urinary symptom, rash or other symptom is bacterial or suitable for this product. Cause, testing when relevant, market label and professional assessment must be checked separately." }, { "zh": "与其他抗菌药的作用路径相似、不同或名称中都含“磺胺”或“甲氧苄啶”，都不能说明可以自行叠加、轮换、按 mg 等量换算或用余药续用。准确产品、感染评估、肾功能相关情况、完整药单和现行标签需要由专业人员逐项核对。", "en": "A related or different pathway with another antibacterial, or a name containing “sulfa” or “trimethoprim,” does not permit self-combination, alternation, milligram conversion or use of leftovers. The exact product, infection assessment, kidney-related context, complete medicine list and current label need item-by-item professional review." }, { "zh": "机制不能消除严重皮肤反应、血液、肾脏、钾水平或药物相互作用的风险，也不能用于决定是否突然自行停药。出现广泛皮疹、黏膜异常、呼吸困难、晕厥、明显虚弱或其他急性严重问题，应优先使用当地医疗支持。", "en": "Mechanism does not remove the possibility of serious skin reactions, blood, kidney, potassium or interaction risks, and it cannot decide abrupt self-stopping. With widespread rash, mucosal abnormality, breathing difficulty, fainting, marked weakness or another acute serious concern, prioritise local medical support." } ], "source": { "id": "src_aa35f64fb63f1003", "label": "DailyMed（NLM）：BACTRIM / BACTRIM DS 公开标签（Sun Pharmaceutical Industries, Inc.，2024-12 更新；Clinical Pharmacology）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=f59d0c04-9c66-4d53-a0e1-cb55570deb62", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "Bactrim", "generic": "复方磺胺甲噁唑", "dosageFormClass": "口服片剂：BACTRIM 400 mg/80 mg；BACTRIM DS 800 mg/160 mg（DailyMed 2024-12 公开标签所列）" }, "labelSource": { "id": "src_aa35f64fb63f1003", "label": "DailyMed（NLM）：BACTRIM / BACTRIM DS 公开标签（Sun Pharmaceutical Industries, Inc.，2024-12 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=f59d0c04-9c66-4d53-a0e1-cb55570deb62", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "productRoutes": [ { "source": { "id": "src_aa35f64fb63f1003", "label": "DailyMed（NLM）：BACTRIM / BACTRIM DS 公开标签（Sun Pharmaceutical Industries, Inc.，2024-12 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=f59d0c04-9c66-4d53-a0e1-cb55570deb62", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_964cf20e87f57c4a", "label": "FDA：BACTRIM 2020 美国静脉用注射剂历史标签（NDA 018374；不等同于本页口服包装）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/018374s027lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [ { "id": "fda-faers-sulfamethoxazole-trimethoprim-2023-hlh-label-update", "issuedAt": "2023-09-30", "status": "fda_potential_signal_label_update_listing", "title": { "zh": "FDA FAERS 记录：磺胺甲噁唑/甲氧苄啶的标签更新线索", "en": "FDA FAERS record: labelling-update information for sulfamethoxazole/trimethoprim" }, "summary": { "zh": "FDA 的 2023 年 7–9 月潜在严重风险/新安全信息表（页面更新至 2026-03-13）列出 Bactrim、Bactrim DS 等磺胺甲噁唑/甲氧苄啶产品，并说明标签“警告和注意事项”及“不良反应”部分已于 2025 年 2 月加入噬血细胞性淋巴组织细胞增多症（HLH）信息。它是监管安全信号及标签更新记录，不用来判断个人是否发生该情况，也不提供自行停药或换药结论。", "en": "FDA’s July–September 2023 potential-signal/new-safety-information table, updated on 2026-03-13, lists Bactrim, Bactrim DS and related sulfamethoxazole/trimethoprim products and states that Warnings and Precautions and Adverse Reactions were updated in February 2025 with hemophagocytic lymphohistiocytosis (HLH) information. It is a regulatory safety-signal and labelling-update record, not a way to determine an individual event or self-stop/switch treatment." }, "source": { "id": "src_8c74002392ff8c7f", "label": "FDA：FAERS 2023 年 7–9 月潜在严重风险/新安全信息表（磺胺甲噁唑/甲氧苄啶标签更新）", "url": "https://www.fda.gov/drugs/fda-adverse-event-monitoring-system-aems/july-september-2023-potential-signals-serious-risksnew-safety-information-identified-fda-adverse", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-hosted-amneal-2025-sulfamethoxazole-trimethoprim-recall", "issuedAt": "2025-06-04", "status": "fda_hosted_company_recall_announcement", "title": { "zh": "FDA 托管的企业召回公告：特定 Amneal 复方磺胺甲噁唑/甲氧苄啶片", "en": "FDA-hosted company recall announcement: specific Amneal sulfamethoxazole/trimethoprim tablets" }, "summary": { "zh": "FDA 页面明确说明这是其作为公共服务托管的企业公告，并不表示 FDA 认可企业或产品。公告仅涉及美国 Amneal 的磺胺甲噁唑/甲氧苄啶 400 mg/80 mg 片、3 个批号（AM241019、AM241019A、AM241020）及列明 NDC/包装；不适用于 Bactrim 品牌、Bactrim DS、800 mg/160 mg、其他生产商、其他批号、其他市场或任何当前产品状态结论。", "en": "FDA explicitly says this is a company announcement it posts as a public service and does not endorse the company or product. The announcement concerns only U.S. Amneal sulfamethoxazole/trimethoprim 400 mg/80 mg tablets, three named lots (AM241019, AM241019A, AM241020), and the listed NDCs/packs. It does not apply to Bactrim brand, Bactrim DS, 800 mg/160 mg, another manufacturer, another lot, another market, or any current-product-status conclusion." }, "source": { "id": "src_bc33da5bc62a9c5f", "label": "FDA 托管：Amneal 磺胺甲噁唑/甲氧苄啶片 400 mg/80 mg 特定批次召回企业公告（2025-06-04）", "url": "https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/amneal-pharmaceutical-llc-issues-nationwide-recall-sulfamethoxazole-trimethoprim-tablets-usp-400", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "DailyMed 的 Sun Pharmaceutical Industries, Inc. BACTRIM 公开标签列示口服 BACTRIM 400 mg/80 mg 片和 BACTRIM DS（double strength）800 mg/160 mg 片。本页包装图严格对应 DS 800 mg/160 mg、100 片瓶装（NDC 49708-146-01）；不把该包装延伸为注射剂、其他规格、其他市场批准、原研关系、供应、价格或可售资格结论。", "history": "同一品牌下的常规片与 DS 片包含相同两种活性成分，但每片标示量不同；口服标签也不能与此前的静脉用历史文件自动等同。产品身份、实际包装、目标市场、标签版本与专业使用信息须分别核验。", "sourceDocuments": [ { "id": "src_aa35f64fb63f1003", "label": "DailyMed（NLM）：BACTRIM / BACTRIM DS 公开标签（Sun Pharmaceutical Industries, Inc.，2024-12 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=f59d0c04-9c66-4d53-a0e1-cb55570deb62", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_964cf20e87f57c4a", "label": "FDA：BACTRIM 2020 美国静脉用注射剂历史标签（NDA 018374；不等同于本页口服包装）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/018374s027lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_5ed30b676fbb9773", "label": "FDA Drugs@FDA 官方检索入口", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_lookup_entry", "documentKind": "regulatory_lookup", "market": "US", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } ], "applicationNumber": "NDA 017377（DailyMed 公开标签所列美国市场标识）", "approvalTimeline": [ { "date": "2024-12", "title": { "zh": "FDA 标签档案版本", "en": "FDA label archive version" }, "detail": { "zh": "本页链接 2024-12 的 FDA 标签档案作为可复核阅读入口。现行标签、规格、适应症和安全信息必须另行以目标市场当前文件核对。", "en": "This page links the 2024-12 FDA label archive as a traceable reading entry point. Current labeling, strength, indication and safety information require separate verification against the target market’s current document." }, "source": { "id": "src_aa35f64fb63f1003", "label": "DailyMed: BACTRIM / BACTRIM DS public label archive", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=f59d0c04-9c66-4d53-a0e1-cb55570deb62", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "已链接公开标签档案", "en": "Public label archive linked" }, "detail": { "zh": "仅对应本页所列 FDA 文件。", "en": "Only the FDA document listed on this page is linked." } }, { "market": { "zh": "中国大陆、欧盟、日本", "en": "Mainland China, EU, Japan" }, "status": { "zh": "待逐项建立市场记录", "en": "Market record not established" }, "detail": { "zh": "不从美国标签档案推定当地批准、持有人、规格、供应或可售资格。", "en": "No local approval, holder, strength, supply or sale-eligibility conclusion is inferred from the U.S. label archive." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "标签档案能代表现在的产品信息吗？", "en": "Does a label archive represent current product information?" }, "answer": { "zh": "不能自动代表。档案用于定位来源；需要以目标市场的现行官方标签逐项复核。", "en": "Not automatically. The archive locates a source; each point needs verification against the target market’s current official label." } }, { "question": { "zh": "为什么这里不展示价格或原研/仿制结论？", "en": "Why are price and originator/generic conclusions not shown?" }, "answer": { "zh": "这些结论需要产品、剂型、规格、包装、市场、日期和原始记录分别齐全并经人工审核；单一标签文件不足以支持。", "en": "Those conclusions require separately complete and human-reviewed product, dosage-form, strength, pack, market, date and primary-record fields; one label file is insufficient." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "how-to-read-a-drug-label", "regulatory-sources-first" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/bactrim/", "en": "https://origindrug.com/en/drugs/bactrim/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "flagyl-metronidazole", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-24", "status": "published_traceable_archive" }, "names": { "brand": "FLAGYL", "generic": "甲硝唑", "aliases": [ "FLAGYL", "甲硝唑", "metronidazole", "Flagyl 375" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "感染", "sourceArchiveMarket": "美国：DailyMed 公开标签（SPL v25，2026-05-25 发布）仅对应 FLAGYL（metronidazole）375 mg 口服胶囊、NDC 0025-1942-50、50 粒瓶装。它不建立中国大陆、欧盟、日本或其他市场的当前批准、供应、原研/仿制关系、包装、可得性或可售资格。", "dosageFormClass": "甲硝唑口服胶囊：每粒 375 mg（美国公开标签所列；NDC 0025-1942-50，50 粒瓶装）", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "本页不由单一公开标签推定首次批准年份；应按目标市场官方批准档案核验", "archiveSponsorText": "Pfizer Laboratories, Division of Pfizer Inc.（美国公开标签所列标签方）" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [ "metronidazole injection", "甲硝唑注射液", "metronidazole vaginal", "甲硝唑阴道制剂" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-flagyl-metronidazole-capsule-375mg-50-bottle-ndc-0025-1942-50", "marketCode": "US", "labelVersion": { "zh": "DailyMed 美国公开标签（Pfizer；SPL v25，2026-05-25 发布）", "en": "U.S. DailyMed public label (Pfizer; SPL v25, published 25 May 2026)" }, "dosageForm": { "zh": "FLAGYL 甲硝唑口服胶囊", "en": "FLAGYL metronidazole oral capsule" }, "route": { "zh": "口服（标签产品身份字段）", "en": "oral (label product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 0025-1942-50", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_capsule", "primaryDisplay": { "zh": "每粒 375 mg；50 粒瓶装", "en": "375 mg per capsule; 50-capsule bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=a2883ca1-5a9a-4259-9d80-46ab67274384&name=flagyl-03.jpg", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "甲硝唑", "en": "metronidazole" }, "value": 375, "unit": "mg", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒标签标示量；不是个人粒数、疗程或换算", "en": "labelled amount per capsule; not an individual's capsule count, course or conversion" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 50, "countUnit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-24", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 50, "unit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "physicalClues": { "color": { "zh": "铁灰色不透明胶囊体、浅绿色不透明胶囊帽", "en": "iron-gray opaque body and light-green opaque cap" }, "shape": null, "imprint": "375 mg / FLAGYL", "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_32af4fe72f61f7fb", "label": "DailyMed（NLM）：FLAGYL 甲硝唑 375 mg、50 粒瓶装美国公开标签面板（Pfizer；SPL v25，2026-05-25 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a2883ca1-5a9a-4259-9d80-46ab67274384", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-24", "reviewedAt": "2026-08-24" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-flagyl-metronidazole-capsule-375mg-50-bottle-ndc-0025-1942-50", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=a2883ca1-5a9a-4259-9d80-46ab67274384&name=flagyl-03.jpg", "alt": "FLAGYL 甲硝唑 375 mg 口服胶囊在美国 DailyMed Pfizer 公开标签中的 50 粒瓶装标签图", "archiveMarket": "美国", "labelVersion": "DailyMed SPL v25（2026-05-25 发布）", "presentation": "FLAGYL 甲硝唑：每粒 375 mg、NDC 0025-1942-50、50 粒瓶装标签图（DailyMed Pfizer 公开标签所列）。", "notice": "此图只对应美国 DailyMed 公开标签中的 FLAGYL、甲硝唑 375 mg 口服胶囊、NDC 0025-1942-50 与 50 粒瓶装。它只帮助核对品牌、通用名、每粒标示量、胶囊、包装数量和来源；不用于鉴定真伪，也不证明片剂、注射液、阴道制剂、其他强度、其他包装、其他市场标签、当前可得性、原研身份、目标市场批准或任何个人的粒数、疗程、联用、停用或换药方案。", "source": { "id": "src_32af4fe72f61f7fb", "label": "DailyMed（NLM）：FLAGYL 甲硝唑 375 mg、50 粒瓶装美国公开标签面板（Pfizer；SPL v25，2026-05-25 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a2883ca1-5a9a-4259-9d80-46ab67274384", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-24", "reviewedAt": "2026-08-24" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "FLAGYL／甲硝唑说明书放大阅读：375 mg 是每粒胶囊的身份，不是个人粒数公式", "en": "FLAGYL label reading: 375 mg identifies each capsule; it is not an individual capsule-count formula" }, "summary": { "zh": "本模块以 Pfizer 的美国 DailyMed 公开标签为阅读入口，帮助核对 FLAGYL、甲硝唑、每粒 375 mg、口服胶囊、NDC 0025-1942-50、50 粒瓶装与标签警示。它不决定个人是否需要抗感染治疗、每次或每天几粒、疗程、是否饮酒、与华法林或其他药物同服、停用或换药。", "en": "This module uses Pfizer's U.S. DailyMed public label to check FLAGYL, metronidazole, 375 mg per capsule, oral capsule, NDC 0025-1942-50, the 50-capsule bottle and label warnings. It does not decide an individual's need for anti-infective treatment, capsule count, course, alcohol use, co-use with warfarin or another medicine, stopping or switching." }, "checks": [ { "zh": "先同时核对 FLAGYL、甲硝唑、每粒 375 mg、口服胶囊、NDC 0025-1942-50、50 粒瓶装和目标市场。375 mg 是这一准确胶囊每一粒的标签标示量，50 粒是包装数量；它们不是网页给任何人计算用量、疗程或与另一种甲硝唑产品换算的答案。", "en": "Check FLAGYL, metronidazole, 375 mg per capsule, oral-capsule form, NDC 0025-1942-50, the 50-capsule bottle and target market together. 375 mg is the labelled amount in each exact capsule and 50 is the pack count; neither is a web answer for personal use, course length or conversion to another metronidazole product." }, { "zh": "该标签把胶囊、片剂、注射制剂、阴道制剂和其他抗感染药视为不同产品问题。相同通用名、相近包装、同写 mg 或“抗菌药”都不能证明可以自行改剂型、叠加、轮换、用余药续用或因症状相似就开始使用。", "en": "The label context treats capsules, tablets, injections, vaginal products and other anti-infectives as different product questions. A matching generic name, similar package, shared mg wording or the label 'antibacterial' does not establish self-directed form changes, combination, alternation, leftover use or starting treatment for a similar symptom." }, { "zh": "标签列出与酒精或含丙二醇产品、华法林及其他口服香豆素抗凝药等相关的核对事项，并提示严重皮肤反应等风险。请把所有处方药、非处方药、补充剂和实际药盒交给药师或开方团队逐项核对；网页不能把这些警示变成个人的“能用/不能用”或停药安排。", "en": "The label identifies matters to check involving alcohol or propylene-glycol-containing products, warfarin and other oral coumarin anticoagulants, and flags serious skin reactions among other risks. Give all prescription medicines, OTC products, supplements and actual packs to a pharmacist or prescriber for item-by-item review; a webpage cannot turn these warnings into an individual's 'can/cannot use' or stopping plan." }, { "zh": "出现广泛皮疹、水疱、发热、黏膜异常、严重腹痛、昏厥、呼吸困难或其他急性严重不适时，应优先使用当地医疗支持；不要等待网页答复，也不要用同时停换多种药来试探原因。", "en": "With widespread rash, blisters, fever, mucosal changes, severe abdominal pain, fainting, breathing difficulty or another acute serious concern, prioritise local medical support; do not wait for a web response or test the cause by stopping and changing several medicines at once." } ], "source": { "id": "src_32af4fe72f61f7fb", "label": "DailyMed（NLM）：FLAGYL 甲硝唑美国公开标签（Pfizer；产品身份、警示与相互作用阅读）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a2883ca1-5a9a-4259-9d80-46ab67274384", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-24", "reviewedAt": "2026-08-24" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "甲硝唑怎样起作用：它在敏感厌氧菌内经还原后影响 DNA 合成", "en": "How metronidazole works: in susceptible anaerobic bacteria, reduction can affect DNA synthesis" }, "summary": { "zh": "DailyMed 的 FLAGYL 标签将甲硝唑描述为硝基咪唑类抗菌药：在敏感厌氧菌内被还原后，可形成与 DNA 相互作用的产物，抑制 DNA 合成并导致 DNA 降解。标签同时说明其精确机制并不完全清楚。此处只解释药理路径，不诊断感染、不决定是否需要抗菌药、产品选择、粒数、疗程、联用或换药。", "en": "The FLAGYL DailyMed label describes metronidazole as a nitroimidazole antibacterial: after reduction in susceptible anaerobic bacteria, products can interact with DNA, inhibit DNA synthesis and lead to DNA degradation. The label also says its precise mechanism is not fully understood. This explains a pharmacologic pathway only; it does not diagnose infection or decide whether an antibacterial is needed, product selection, capsule count, course, combination or switching." }, "checks": [ { "zh": "“影响 DNA”或“厌氧菌”是标签机制线索，不是从网页判断腹痛、腹泻、阴道不适、口腔问题、发热或其他症状病因的工具，也不代表每一种感染都适合甲硝唑。", "en": "“Affecting DNA” or “anaerobic bacteria” is a label mechanism clue, not a website tool for diagnosing abdominal pain, diarrhoea, vaginal discomfort, oral concerns, fever or another symptom, and it does not mean every infection is suitable for metronidazole." }, { "zh": "与其他抗菌药的机制相似或不同，都不表示能自行把多种抗感染药拼在一起、交替、按 mg 换算或用余药续用。准确产品、病因评估、目标市场标签、完整药单和专业判断必须一起核对。", "en": "A related or different mechanism from another antibacterial does not permit self-combining, alternating, milligram conversion or leftover use. The exact product, cause assessment, target-market label, complete medicine list and professional judgment need review together." }, { "zh": "机制不能替代对过敏、严重皮肤反应、神经系统不适、肝脏情况、抗凝药联用或其他风险的产品级核对。出现新发或严重不适时，应联系当地药师、医生或紧急医疗支持。", "en": "Mechanism cannot replace product-level checking for allergy, serious skin reactions, neurologic symptoms, liver context, anticoagulant co-use or other risks. With a new or serious concern, contact local pharmacist, clinician or emergency support." } ], "source": { "id": "src_32af4fe72f61f7fb", "label": "DailyMed（NLM）：FLAGYL 甲硝唑美国公开标签（Mechanism of Action）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a2883ca1-5a9a-4259-9d80-46ab67274384", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-24", "reviewedAt": "2026-08-24" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "FLAGYL", "generic": "甲硝唑", "dosageFormClass": "甲硝唑口服胶囊：每粒 375 mg（美国公开标签所列；NDC 0025-1942-50，50 粒瓶装）" }, "labelSource": { "id": "src_32af4fe72f61f7fb", "label": "DailyMed（NLM）：FLAGYL 甲硝唑 375 mg 口服胶囊美国公开标签（Pfizer；SPL v25，2026-05-25 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a2883ca1-5a9a-4259-9d80-46ab67274384", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-24", "reviewedAt": "2026-08-24" }, "productRoutes": [ { "source": { "id": "src_32af4fe72f61f7fb", "label": "DailyMed（NLM）：FLAGYL 甲硝唑 375 mg 口服胶囊美国公开标签（Pfizer；SPL v25，2026-05-25 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a2883ca1-5a9a-4259-9d80-46ab67274384", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-24", "reviewedAt": "2026-08-24" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-24", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-24", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "DailyMed 的 Pfizer FLAGYL（metronidazole）美国公开标签列示 375 mg 口服胶囊、NDC 0025-1942-50、50 粒瓶装，以及相应的成分、警示与来源文件。本页帮助把商品名、通用名、每粒标示量、胶囊、包装与目标市场放在一起阅读；不把 375 mg 或 50 粒包装换算为个人该服几粒、疗程、能否与其他抗感染药同服、停用、换药或购买结论。", "history": "FLAGYL 375 这份美国公开标签中，375 mg 表示这一准确胶囊每粒的标示量，50 粒表示这一准确瓶装的包装数量。它不等于任何人的处方片数或疗程，也不能与甲硝唑片剂、注射液、阴道制剂、其他强度、其他厂家或其他市场的产品按数字自行换算、替换或叠加。", "sourceDocuments": [ { "id": "src_32af4fe72f61f7fb", "label": "DailyMed（NLM）：FLAGYL 甲硝唑 375 mg 口服胶囊美国公开标签（Pfizer；SPL v25，2026-05-25 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a2883ca1-5a9a-4259-9d80-46ab67274384", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-24", "reviewedAt": "2026-08-24" }, { "id": "src_5ed30b676fbb9773", "label": "FDA Drugs@FDA 官方检索入口（FLAGYL）", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_lookup_entry", "documentKind": "regulatory_lookup", "market": "US", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } ], "applicationNumber": "DailyMed SPL setid a2883ca1-5a9a-4259-9d80-46ab67274384（v25；美国公开标签记录，不据此推定其他市场状态）", "approvalTimeline": [ { "date": "2026-05-25（SPL v25 发布）", "title": { "zh": "当前美国公开标签的日期记录", "en": "Dated current U.S. public-label record" }, "detail": { "zh": "本页链接 2026-05-25（SPL v25 发布） 的当前美国公开标签，作为放大阅读和逐项核对入口。它不替代目标市场当日的批准、供应、适应症、规格或个体化用药判断。", "en": "This page links the current U.S. public label dated 2026-05-25（SPL v25 发布） as an enlarged-reading and item-by-item checking entry point. It does not replace same-day verification of approval, supply, indication, strength or individual use in the target market." }, "source": { "id": "src_32af4fe72f61f7fb", "label": "DailyMed（NLM）：FLAGYL 甲硝唑 375 mg 美国公开标签（Pfizer；SPL v25，2026-05-25 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a2883ca1-5a9a-4259-9d80-46ab67274384", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-24", "reviewedAt": "2026-08-24" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "已链接当前公开标签", "en": "Current public label linked" }, "detail": { "zh": "仅对应本页所列的美国公开标签；不据此推定库存、可售资格或其他市场状态。", "en": "Only the U.S. public label listed on this page is linked; no stock, sale-eligibility or other-market conclusion is inferred." } }, { "market": { "zh": "中国大陆、欧盟、日本", "en": "Mainland China, EU, Japan" }, "status": { "zh": "待逐项建立市场记录", "en": "Market record not established" }, "detail": { "zh": "不从美国公开标签推定当地批准、持有人、规格、供应或可售资格。", "en": "No local approval, holder, strength, supply or sale-eligibility conclusion is inferred from the U.S. public label." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "当前美国标签能代表其他国家或地区吗？", "en": "Does a current U.S. label represent another country or region?" }, "answer": { "zh": "不能。它是逐项阅读入口；品牌、剂型、规格、可得性和安全信息仍须以目标市场的现行官方文件核对。", "en": "No. It is an item-by-item reading entry point; brand, dosage form, strength, availability and safety information still require checking against the target market's current official document." } }, { "question": { "zh": "为什么这里不展示价格或原研/仿制结论？", "en": "Why are price and originator/generic conclusions not shown?" }, "answer": { "zh": "这些结论需要产品、剂型、规格、包装、市场、日期和原始记录分别齐全并经人工审核；单一标签文件不足以支持。", "en": "Those conclusions require separately complete and human-reviewed product, dosage-form, strength, pack, market, date and primary-record fields; one label file is insufficient." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "how-to-read-a-drug-label", "regulatory-sources-first" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/flagyl-metronidazole/", "en": "https://origindrug.com/en/drugs/flagyl-metronidazole/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "cipro", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-21", "status": "published_traceable_archive" }, "names": { "brand": "Cipro", "generic": "环丙沙星", "aliases": [ "ciprofloxacin" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "感染", "sourceArchiveMarket": "美国公开监管标签档案", "dosageFormClass": "口服片剂：250 mg、500 mg；口服混悬液：250 mg/5 mL、500 mg/5 mL（DailyMed 2026 标签所列）", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "1987（DailyMed 2026 标签所列美国初始批准）", "archiveSponsorText": "Bayer / DailyMed 公开标签与 FDA 历史监管档案" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-cipro-tablet-500mg-100-tablet-bottle-ndc-50419-754-01", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v32，2026-03-04 发布；仅为所引公开标签展示面，不代表供应", "en": "DailyMed SPL v32, published 4 Mar 2026; cited public label panel only, not availability" }, "dosageForm": { "zh": "CIPRO 环丙沙星口服薄膜衣片", "en": "CIPRO ciprofloxacin oral film-coated tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 50419-754-01", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片 500 mg；100 片瓶装", "en": "500 mg per tablet; 100-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=image-08.jpg&setid=888dc7f9-ad9c-4c00-8d50-8ddfd9bd27c0&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "环丙沙星", "en": "ciprofloxacin" }, "value": 500, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标示量；不是个人片数、疗程或自行换算", "en": "labelled amount per tablet; not an individual tablet count, course or self-conversion" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-21", "currentLabelDisplayed": true, "ndcDirectoryListed": false, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "略带黄色", "en": "slightly yellowish" }, "shape": { "zh": "胶囊形薄膜衣片", "en": "capsule-shaped film-coated tablet" }, "imprint": "BAYER / CIP 500", "scoreStatus": "functionally_scored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_3a6fc50efe223c5a", "label": "DailyMed（NLM）：CIPRO 当前公开标签（Bayer；SPL v32，2026-03-04 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=888dc7f9-ad9c-4c00-8d50-8ddfd9bd27c0&version=32", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-cipro-oral-suspension-250mg-per-5ml-100ml-kit-ndc-50419-777-01", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v32，2026-03-04 发布；仅为所引公开标签展示面，不代表供应", "en": "DailyMed SPL v32, published 4 Mar 2026; cited public label panel only, not availability" }, "dosageForm": { "zh": "CIPRO 环丙沙星口服混悬液套件（5%）", "en": "CIPRO ciprofloxacin oral suspension kit (5%)" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 50419-777-01", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_5_mL", "primaryDisplay": { "zh": "每 5 mL 含 250 mg；100 mL 复溶后口服混悬液套件", "en": "250 mg per 5 mL; 100 mL reconstituted oral-suspension kit" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=image-09.jpg&setid=888dc7f9-ad9c-4c00-8d50-8ddfd9bd27c0&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "环丙沙星", "en": "ciprofloxacin" }, "value": 250, "unit": "mg", "basisCode": "per_5_mL", "basisLabel": { "zh": "每 5 mL 标签浓度；不是个人毫升数、疗程或与片剂自行换算", "en": "labelled concentration per 5 mL; not an individual's millilitres, course or self-conversion to tablets" } } ], "concentration": { "basisCode": "mass_per_volume", "notation": "250 mg/5 mL", "numerator": { "value": 250, "unit": "mg" }, "denominator": { "value": 5, "unit": "mL" }, "display": { "zh": "250 mg/5 mL（标签浓度；不是个人毫升数）", "en": "250 mg/5 mL (labelled concentration; not an individual's millilitres)" } }, "container": { "typeCode": "reconstitution_kit", "typeLabel": { "zh": "复溶口服混悬液套件", "en": "oral-suspension reconstitution kit" }, "fill": { "value": 100, "unit": "mL" }, "countPerPackage": 1, "countUnit": { "zh": "套件/盒", "en": "kit per carton" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-21", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 1, "unit": { "zh": "套件/盒", "en": "kit per carton" } }, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_3a6fc50efe223c5a", "label": "DailyMed（NLM）：CIPRO 当前公开标签（Bayer；SPL v32，2026-03-04 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=888dc7f9-ad9c-4c00-8d50-8ddfd9bd27c0&version=32", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-cipro-tablet-500mg-100-tablet-bottle-ndc-50419-754-01", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=image-08.jpg&setid=888dc7f9-ad9c-4c00-8d50-8ddfd9bd27c0&type=img", "alt": "CIPRO 500 mg 环丙沙星片在美国 DailyMed 公开标签中的 Bayer 100 片装包装标签图", "archiveMarket": "美国", "labelVersion": "DailyMed 公开标签（2026-03 更新；图稿标注 2014）", "presentation": "CIPRO 500 mg、100 片装包装标签图（DailyMed 公开标签所列；Bayer 标签图）。", "notice": "此为美国 DailyMed 公开标签中明确对应 CIPRO 500 mg、100 片装的 Bayer 包装标签图，只帮助核对品牌、通用名、标示强度、片剂和来源；不用于鉴定真伪，也不证明 250 mg、口服混悬剂、其他包装、其他市场标签、当前包装、原研身份、目标市场批准或可售资格。", "source": { "id": "src_607506de7ddf2b92", "label": "DailyMed（NLM）：CIPRO 公开标签（Bayer，2026-03 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=888dc7f9-ad9c-4c00-8d50-8ddfd9bd27c0", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "CIPRO 说明书放大阅读：片剂、口服混悬液与同类抗菌药不能按经验互换", "en": "CIPRO label reading: tablets, oral suspension and related antibacterials are not interchangeable by experience" }, "summary": { "zh": "本模块以 Bayer 的 DailyMed 2026 美国公开标签为阅读入口，帮助核对 CIPRO、环丙沙星、口服片剂或口服混悬液、每一单位标示强度/浓度和目标市场；它不诊断感染，也不提供个人片数、毫升数、疗程、补用或换药方案。", "en": "This module uses Bayer's 2026 U.S. DailyMed public label as a reading entry point. It helps check CIPRO, ciprofloxacin, oral tablet or oral suspension, stated strength/concentration per unit and target market; it does not diagnose infection or provide an individual's tablet count, millilitres, duration, make-up or switching plan." }, "checks": [ { "zh": "先同时核对 CIPRO、环丙沙星、准确剂型和规格。片剂上的 mg 与口服混悬液的浓度、量具和体积不是同一种信息；相同通用名或相近数字，不能支持自行从“几片”换成“几毫升”，也不能支持把不同制剂拼成一个方案。", "en": "Check CIPRO, ciprofloxacin, exact dosage form and strength together. Milligrams on a tablet and the concentration, measuring device and volume of an oral suspension are not the same information; a shared generic name or nearby number does not support self-conversion from “tablets” to “millilitres” or assembling different forms into one plan." }, { "zh": "FDA 标签对氟喹诺酮类的重要严重不良反应、神经系统及肌腱等问题有专门警示。高龄、既往不适、多药并用或出现新疼痛、感觉异常、精神/神经系统症状时，应带实际包装和完整药单及时请专业人员判断，不要从网页决定继续、加量、停用或改药。", "en": "The FDA label carries dedicated warnings about important serious fluoroquinolone adverse reactions, including nervous-system and tendon-related concerns. With older age, prior reactions, multiple medicines, or new pain, sensory, mental or neurologic symptoms, take the actual package and complete medicine list for timely professional assessment; do not use this page to decide continuation, increase, stopping or a change." }, { "zh": "“都是抗菌药”“都是治疗尿路/呼吸道感染”并不说明可以同时服用、轮换、借给家人或替代另一种药。感染部位、检测、既往用药、肾功能、其他药物和现行标签都需由开方团队逐项核对。", "en": "“Both antibacterials” or “both used for urinary/respiratory infection” does not establish that products can be taken together, alternated, shared with family or substituted. Infection site, testing, prior treatment, kidney function, other medicines and the current label all need item-by-item review by the prescribing team." }, { "zh": "药盒照片、颜色和本页来源链接只帮助核对阅读对象，不能鉴定真伪、决定是否需要抗菌药或取代急性病情评估。出现严重或迅速恶化的不适、过敏相关症状或不确定如何使用时，应走当地医疗支持渠道。", "en": "Package photos, colours and this page’s source link only help identify what is being read; they cannot authenticate a medicine, decide whether an antibacterial is needed or replace assessment of acute illness. With severe or rapidly worsening illness, allergy-related symptoms or uncertainty about use, use local medical-support pathways." } ], "source": { "id": "src_3a6fc50efe223c5a", "label": "DailyMed（NLM）：CIPRO 公开标签（Bayer，2026-03 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=888dc7f9-ad9c-4c00-8d50-8ddfd9bd27c0&version=32", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "环丙沙星怎样起作用：它抑制细菌 DNA 复制所需的两种拓扑异构酶", "en": "How ciprofloxacin works: it inhibits two topoisomerases required for bacterial DNA replication" }, "summary": { "zh": "Bayer 的 DailyMed 2026 公开标签说明环丙沙星的杀菌作用来自抑制细菌拓扑异构酶 II（DNA 旋转酶）和拓扑异构酶 IV；这些酶与细菌 DNA 的复制、转录、修复和重组有关。机制帮助理解它是抗菌药，而不诊断感染、不决定个人剂量、疗程或是否应使用。", "en": "Bayer's 2026 DailyMed public label states that ciprofloxacin's bactericidal action results from inhibition of bacterial topoisomerase II (DNA gyrase) and topoisomerase IV, enzymes involved in bacterial DNA replication, transcription, repair and recombination. This explains an antibacterial mechanism; it does not diagnose infection or decide an individual's dose, duration or need for treatment." }, "checks": [ { "zh": "机制与“抗菌”二字都不能区分病毒、细菌或其他原因造成的症状，更不能把任一发热、咳嗽、腹泻或尿路不适变成自行开始抗菌药的依据。适用性需要临床判断、检查资料与准确产品的现行标签。", "en": "Neither mechanism nor the word “antibacterial” distinguishes viral, bacterial or other causes of symptoms, and neither turns any fever, cough, diarrhoea or urinary symptom into a basis for self-starting an antibacterial. Suitability needs clinical judgment, testing information and the current label for the exact product." }, { "zh": "与其他抗菌药类别不同的机制，不表示可以自行联用、轮换或在一个疗程中替换。抗菌药选择、转换与复核必须依据具体感染、培养/敏感性等资料、完整药单和开方团队。", "en": "A mechanism that differs from other antibacterial classes does not permit self-combination, alternation or substitution during a course. Antibacterial selection, conversion and review must use the specific infection, information such as culture/susceptibility when relevant, the complete medicine list and the prescribing team." }, { "zh": "片剂与口服混悬液具有相同的活性成分并不使其可由机制自行换算。每种具体包装的浓度、强度、量具、标签版本与处方都必须单独核对。", "en": "A shared active ingredient in a tablet and oral suspension does not make them convertible from mechanism alone. Concentration, strength, measuring device, label version and prescription for each exact package must be checked separately." } ], "source": { "id": "src_3a6fc50efe223c5a", "label": "DailyMed（NLM）：CIPRO 公开标签（Bayer，2026-03 更新；临床药理）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=888dc7f9-ad9c-4c00-8d50-8ddfd9bd27c0&version=32", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "Cipro", "generic": "环丙沙星", "dosageFormClass": "口服片剂：250 mg、500 mg；口服混悬液：250 mg/5 mL、500 mg/5 mL（DailyMed 2026 标签所列）" }, "labelSource": { "id": "src_3a6fc50efe223c5a", "label": "DailyMed（NLM）：CIPRO 公开标签（Bayer，2026-03 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=888dc7f9-ad9c-4c00-8d50-8ddfd9bd27c0&version=32", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "productRoutes": [ { "source": { "id": "src_3a6fc50efe223c5a", "label": "DailyMed（NLM）：CIPRO 公开标签（Bayer，2026-03 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=888dc7f9-ad9c-4c00-8d50-8ddfd9bd27c0&version=32", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_949a8bafda6a536b", "label": "FDA：CIPRO 2016 美国历史标签（NDA 020780）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020780s043lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [ { "id": "fda-2013-systemic-fluoroquinolone-peripheral-neuropathy-label-change", "issuedAt": "2013-08-15", "status": "fda_class_safety_communication", "title": { "zh": "FDA 药物安全通讯：全身用氟喹诺酮类的周围神经病变标签更新", "en": "FDA Drug Safety Communication: peripheral-neuropathy label updates for systemic fluoroquinolones" }, "summary": { "zh": "FDA 于 2013-08-15 发布药物安全通讯，要求全身用（口服或注射）氟喹诺酮类的说明书和患者用药指南更清楚说明周围神经病变风险；公告明确列出 Levaquin、Cipro 和 Avelox，并说明该风险可在开始用药后不久出现且可能持续。本记录是特定日期的美国类别监管通讯，不把同类关系变成任何个人的停药、改药、剂型转换或症状归因结论；出现疼痛、灼热、麻刺、麻木、无力或感觉异常等急性或令人担忧的不适，应使用当地医疗支持并由专业人员核对实际产品与完整药单。", "en": "On 2013-08-15, FDA issued a Drug Safety Communication requiring clearer peripheral-neuropathy information in labels and Medication Guides for systemic (oral or injectable) fluoroquinolones. The notice explicitly lists Levaquin, Cipro and Avelox, and says this risk may occur soon after treatment starts and may persist. This is a dated U.S. class communication; it does not turn class membership into an individual stop, switch, dosage-form conversion or symptom-attribution conclusion. With acute or concerning pain, burning, tingling, numbness, weakness or altered sensation, use local medical support and have a professional check the actual product and complete medicine list." }, "source": { "id": "src_15292a025a5f8cfe", "label": "FDA：2013-08-15 全身用氟喹诺酮类周围神经病变标签更新药物安全通讯", "url": "https://www.fda.gov/media/86575/download", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "Bayer 的 DailyMed CIPRO（ciprofloxacin hydrochloride）2026 美国公开标签列示 250 mg、500 mg 口服片，以及 250 mg/5 mL、500 mg/5 mL 口服混悬液，并列出美国初始批准年份为 1987。本页把当前公开标签与 FDA 2016 历史文件分开保留，用于核对品牌、通用名、剂型、强度/浓度、包装图和版本；不据此推定其他市场批准、持有人、原研关系、供应或可售资格。", "history": "片剂上的 mg 与口服混悬液的 mg/5 mL 是不同的身份字段，不能仅按通用名或相近数字互相换算。页面所示 Bayer 500 mg 包装图只对应该标签列示的一个口服片包装；历史 FDA 文件不能替代现行标签，现行标签也不构成个人使用、换药或购买结论。", "sourceDocuments": [ { "id": "src_3a6fc50efe223c5a", "label": "DailyMed（NLM）：CIPRO 公开标签（Bayer，2026-03 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=888dc7f9-ad9c-4c00-8d50-8ddfd9bd27c0&version=32", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_949a8bafda6a536b", "label": "FDA：CIPRO 2016 美国历史标签（NDA 020780）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020780s043lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_5ed30b676fbb9773", "label": "FDA Drugs@FDA 官方检索入口", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_lookup_entry", "documentKind": "regulatory_lookup", "market": "US", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } ], "applicationNumber": "NDA 020780", "approvalTimeline": [ { "date": "1987", "title": { "zh": "FDA 标签所列美国初始批准年份", "en": "Initial U.S. approval year listed in the FDA label" }, "detail": { "zh": "本页链接的 FDA 标签档案列示 Initial U.S. Approval: 1987。该历史定位不等同于当前批准、可得性、持有人或其他市场状态。", "en": "The FDA label archive linked here lists Initial U.S. Approval: 1987. This historical locator is not a conclusion about current approval, availability, holder or another market." }, "source": { "id": "src_949a8bafda6a536b", "label": "FDA: CIPRO label archive", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020780s043lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, { "date": "2016-07", "title": { "zh": "FDA 标签档案版本", "en": "FDA label archive version" }, "detail": { "zh": "本页链接 2016-07 的 FDA 标签档案作为可复核阅读入口。现行标签、规格、适应症和安全信息必须另行以目标市场当前文件核对。", "en": "This page links the 2016-07 FDA label archive as a traceable reading entry point. Current labeling, strength, indication and safety information require separate verification against the target market’s current document." }, "source": { "id": "src_949a8bafda6a536b", "label": "FDA: CIPRO label archive", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020780s043lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "已链接公开标签档案", "en": "Public label archive linked" }, "detail": { "zh": "仅对应本页所列 FDA 文件。", "en": "Only the FDA document listed on this page is linked." } }, { "market": { "zh": "中国大陆、欧盟、日本", "en": "Mainland China, EU, Japan" }, "status": { "zh": "待逐项建立市场记录", "en": "Market record not established" }, "detail": { "zh": "不从美国标签档案推定当地批准、持有人、规格、供应或可售资格。", "en": "No local approval, holder, strength, supply or sale-eligibility conclusion is inferred from the U.S. label archive." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "标签档案能代表现在的产品信息吗？", "en": "Does a label archive represent current product information?" }, "answer": { "zh": "不能自动代表。档案用于定位来源；需要以目标市场的现行官方标签逐项复核。", "en": "Not automatically. The archive locates a source; each point needs verification against the target market’s current official label." } }, { "question": { "zh": "为什么这里不展示价格或原研/仿制结论？", "en": "Why are price and originator/generic conclusions not shown?" }, "answer": { "zh": "这些结论需要产品、剂型、规格、包装、市场、日期和原始记录分别齐全并经人工审核；单一标签文件不足以支持。", "en": "Those conclusions require separately complete and human-reviewed product, dosage-form, strength, pack, market, date and primary-record fields; one label file is insufficient." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "how-to-read-a-drug-label", "regulatory-sources-first" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/cipro/", "en": "https://origindrug.com/en/drugs/cipro/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "levaquin", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-09-04", "status": "published_traceable_archive" }, "names": { "brand": "Levaquin", "generic": "左氧氟沙星", "aliases": [ "可乐必妥", "可乐必妥®", "CRAVIT", "クラビット", "LEVAQUIN", "TAVANIC", "levofloxacin", "左氧氟沙星", "左氧氟沙星片", "levofloxacin hydrate", "H20000655", "H20040091", "6241013F2020", "6241013F3027", "6241013C2024", "22100AMX00648", "22100AMX00649", "22100AMX00650", "NDA 020634" ], "marketBrandNames": [ { "name": "CRAVIT", "market": { "zh": "日本", "en": "Japan" }, "evidenceStatus": "current_regulatory_record", "note": { "zh": "PMDA 当前产品页列示クラビット片 250 mg、500 mg及细粒 10%，制造销售方为第一三共。", "en": "The current PMDA product page lists CRAVIT (クラビット) 250 mg and 500 mg tablets and 10% fine granules, with Daiichi Sankyo as marketing authorisation holder." }, "source": { "id": "src_c4a454dbd8713307", "label": "PMDA：クラビット片 250 mg／500 mg及细粒 10% 当前产品页", "url": "https://www.pmda.go.jp/PmdaSearch/rdDetail/iyaku/6241013C2024_1?user=1", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, { "name": "可乐必妥", "market": { "zh": "中国大陆", "en": "Mainland China" }, "evidenceStatus": "dated_first_party_historical_leaflet", "note": { "zh": "第一三共中国 2021 年历史完整说明书中的商品名；仅用于有日期的品牌、规格与批准文号档案，不证明当前批准、包装、供应或可售资格。", "en": "Brand name in Daiichi Sankyo China's 2021 historical full leaflet; retained only as dated brand, strength and approval-number evidence, not current approval, pack, supply or sale eligibility." }, "source": { "id": "src_d26a8d5125a9c09d", "label": "第一三共中国：可乐必妥® 左氧氟沙星片 0.5 g 完整说明书（2021，历史公开资料）", "url": "https://www.daiichisankyo.com.cn/data/upload/file/20211112/6377230777353626337639593.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "first_party_leaflet", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, { "name": "LEVAQUIN", "market": { "zh": "美国", "en": "United States" }, "evidenceStatus": "historical_regulatory_record", "note": { "zh": "FDA 2019 历史口服片标签档案中的美国品牌名。", "en": "U.S. brand name in the 2019 FDA historical oral-tablet label archive." }, "source": { "id": "src_4e39fcca7a55ea86", "label": "FDA：LEVAQUIN 2019 美国口服片处方信息（NDA 020634）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020634s072lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-09-13", "reviewedAt": "2026-09-13" } }, { "name": "TAVANIC", "market": { "zh": "欧洲", "en": "Europe" }, "evidenceStatus": "first_party_brand_history", "note": { "zh": "第一三共 2009 年官方资料列出的欧洲品牌名；不替代任何国家现行批准记录。", "en": "European brand name stated in a 2009 Daiichi Sankyo first-party release; it does not replace a current country-specific approval record." }, "source": { "id": "src_6fa55085e6582599", "label": "第一三共：左氧氟沙星全球品牌名与研发来源说明（2009）", "url": "https://www.daiichisankyo.com/media/press_release/detail/index_3886.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "first_party_release", "market": "GLOBAL", "accessStatus": "public_access_with_site_controls", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } } ], "mainlandChinaTradeNameCue": { "value": "可乐必妥®", "status": "discovery_cue_requires_target_market_verification", "source": { "id": "src_5a8b4df02f34aa4c", "label": "第一三共中国：可乐必妥® 左氧氟沙星片 0.1 g 说明书（2021，历史公开资料）", "url": "https://www.daiichisankyo.com.cn/data/upload/file/20211112/6377230695728340551675231.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "first_party_leaflet", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } } }, "identity": { "therapeuticArea": "感染", "sourceArchiveMarket": "日本 PMDA 当前 CRAVIT 产品记录、2025-05 电子说明书包装项目及患者用药指南；美国 FDA LEVAQUIN 口服片历史标签；中国大陆第一三共可乐必妥® 0.1 g 与 0.5 g（均为 2021 年历史完整说明书）资料；欧洲 TAVANIC 品牌历史线索", "dosageFormClass": "日本 PMDA：250 mg、500 mg 片及 10% 细粒；美国历史标签：250 mg、500 mg、750 mg 口服片；中国大陆 2021 年历史完整说明书：0.1 g、0.5 g 口服片（市场与版本须分别核对）", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "1993（第一三共官方历史：日本 CRAVIT 上市）／1996（FDA 2019 标签所列美国初始批准）", "archiveSponsorText": "第一三共研发与全球品牌历史；PMDA 日本当前产品记录、2025 电子说明书与患者用药指南；日本厚生劳动省药价代码目录；Janssen / FDA 美国历史标签；第一三共中国历史公开说明书" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [ "クラビット点眼液" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "jp-cravit-tablet-250mg-100-bottle-current-2025", "marketCode": "JP", "labelVersion": { "zh": "PMDA 日本当前电子说明书（2025-05-20；第 2 版）", "en": "Current PMDA Japan electronic label (20 May 2025; version 2)" }, "dosageForm": { "zh": "クラビット（CRAVIT）左氧氟沙星水合物 250 mg 口服片", "en": "CRAVIT levofloxacin hydrate 250 mg oral tablet" }, "route": { "zh": "口服（日本当前产品身份字段）", "en": "oral (current Japan product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "6241013F2020", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片以左氧氟沙星计 250 mg；100 片塑料瓶散装（日本当前标签）", "en": "250 mg levofloxacin per tablet; 100-tablet loose-fill plastic bottle (current Japan label)" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "左氧氟沙星（以左氧氟沙星水合物计）", "en": "levofloxacin (as levofloxacin hydrate)" }, "value": 250, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片日本当前标签标示量；不是个人片数、频率或疗程", "en": "current Japan labelled amount per tablet; not an individual tablet count, frequency or course" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": null, "package": { "count": 100, "unit": { "zh": "片/包装", "en": "tablets per pack" } }, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_fa1bb1e9b9a9d12d", "label": "PMDA：クラビット片 250 mg／500 mg、细粒 10% 日本当前电子说明书（2025-05-20；包装项目）", "url": "https://www.pmda.go.jp/PmdaSearch/iyakuDetail/ResultDataSetPDF/430574_6241013C2024_1_24", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "jp-cravit-tablet-250mg-100-ptp-current-2025", "marketCode": "JP", "labelVersion": { "zh": "PMDA 日本当前电子说明书（2025-05-20；第 2 版）", "en": "Current PMDA Japan electronic label (20 May 2025; version 2)" }, "dosageForm": { "zh": "クラビット（CRAVIT）左氧氟沙星水合物 250 mg 口服片", "en": "CRAVIT levofloxacin hydrate 250 mg oral tablet" }, "route": { "zh": "口服（日本当前产品身份字段）", "en": "oral (current Japan product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "6241013F2020", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片以左氧氟沙星计 250 mg；PTP 100 片（10 片×10）（日本当前标签）", "en": "250 mg levofloxacin per tablet; 100-tablet PTP pack (10 × 10) (current Japan label)" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "左氧氟沙星（以左氧氟沙星水合物计）", "en": "levofloxacin (as levofloxacin hydrate)" }, "value": 250, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片日本当前标签标示量；不是个人片数、频率或疗程", "en": "current Japan labelled amount per tablet; not an individual tablet count, frequency or course" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": null, "package": { "count": 100, "unit": { "zh": "片/包装", "en": "tablets per pack" } }, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_fa1bb1e9b9a9d12d", "label": "PMDA：クラビット片 250 mg／500 mg、细粒 10% 日本当前电子说明书（2025-05-20；包装项目）", "url": "https://www.pmda.go.jp/PmdaSearch/iyakuDetail/ResultDataSetPDF/430574_6241013C2024_1_24", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "jp-cravit-tablet-250mg-500-ptp-current-2025", "marketCode": "JP", "labelVersion": { "zh": "PMDA 日本当前电子说明书（2025-05-20；第 2 版）", "en": "Current PMDA Japan electronic label (20 May 2025; version 2)" }, "dosageForm": { "zh": "クラビット（CRAVIT）左氧氟沙星水合物 250 mg 口服片", "en": "CRAVIT levofloxacin hydrate 250 mg oral tablet" }, "route": { "zh": "口服（日本当前产品身份字段）", "en": "oral (current Japan product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "6241013F2020", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片以左氧氟沙星计 250 mg；PTP 500 片（10 片×50）（日本当前标签）", "en": "250 mg levofloxacin per tablet; 500-tablet PTP pack (10 × 50) (current Japan label)" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "左氧氟沙星（以左氧氟沙星水合物计）", "en": "levofloxacin (as levofloxacin hydrate)" }, "value": 250, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片日本当前标签标示量；不是个人片数、频率或疗程", "en": "current Japan labelled amount per tablet; not an individual tablet count, frequency or course" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": null, "package": { "count": 500, "unit": { "zh": "片/包装", "en": "tablets per pack" } }, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_fa1bb1e9b9a9d12d", "label": "PMDA：クラビット片 250 mg／500 mg、细粒 10% 日本当前电子说明书（2025-05-20；包装项目）", "url": "https://www.pmda.go.jp/PmdaSearch/iyakuDetail/ResultDataSetPDF/430574_6241013C2024_1_24", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "jp-cravit-tablet-500mg-100-bottle-current-2025", "marketCode": "JP", "labelVersion": { "zh": "PMDA 日本当前电子说明书（2025-05-20；第 2 版）", "en": "Current PMDA Japan electronic label (20 May 2025; version 2)" }, "dosageForm": { "zh": "クラビット（CRAVIT）左氧氟沙星水合物 500 mg 口服片", "en": "CRAVIT levofloxacin hydrate 500 mg oral tablet" }, "route": { "zh": "口服（日本当前产品身份字段）", "en": "oral (current Japan product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "6241013F3027", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片以左氧氟沙星计 500 mg；100 片塑料瓶散装（日本当前标签）", "en": "500 mg levofloxacin per tablet; 100-tablet loose-fill plastic bottle (current Japan label)" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "左氧氟沙星（以左氧氟沙星水合物计）", "en": "levofloxacin (as levofloxacin hydrate)" }, "value": 500, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片日本当前标签标示量；不是个人片数、频率或疗程", "en": "current Japan labelled amount per tablet; not an individual tablet count, frequency or course" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": null, "package": { "count": 100, "unit": { "zh": "片/包装", "en": "tablets per pack" } }, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_fa1bb1e9b9a9d12d", "label": "PMDA：クラビット片 250 mg／500 mg、细粒 10% 日本当前电子说明书（2025-05-20；包装项目）", "url": "https://www.pmda.go.jp/PmdaSearch/iyakuDetail/ResultDataSetPDF/430574_6241013C2024_1_24", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "jp-cravit-tablet-500mg-50-ptp-current-2025", "marketCode": "JP", "labelVersion": { "zh": "PMDA 日本当前电子说明书（2025-05-20；第 2 版）", "en": "Current PMDA Japan electronic label (20 May 2025; version 2)" }, "dosageForm": { "zh": "クラビット（CRAVIT）左氧氟沙星水合物 500 mg 口服片", "en": "CRAVIT levofloxacin hydrate 500 mg oral tablet" }, "route": { "zh": "口服（日本当前产品身份字段）", "en": "oral (current Japan product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "6241013F3027", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片以左氧氟沙星计 500 mg；PTP 50 片（5 片×10）（日本当前标签）", "en": "500 mg levofloxacin per tablet; 50-tablet PTP pack (5 × 10) (current Japan label)" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "左氧氟沙星（以左氧氟沙星水合物计）", "en": "levofloxacin (as levofloxacin hydrate)" }, "value": 500, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片日本当前标签标示量；不是个人片数、频率或疗程", "en": "current Japan labelled amount per tablet; not an individual tablet count, frequency or course" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": null, "package": { "count": 50, "unit": { "zh": "片/包装", "en": "tablets per pack" } }, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_fa1bb1e9b9a9d12d", "label": "PMDA：クラビット片 250 mg／500 mg、细粒 10% 日本当前电子说明书（2025-05-20；包装项目）", "url": "https://www.pmda.go.jp/PmdaSearch/iyakuDetail/ResultDataSetPDF/430574_6241013C2024_1_24", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "jp-cravit-tablet-500mg-100-ptp-current-2025", "marketCode": "JP", "labelVersion": { "zh": "PMDA 日本当前电子说明书（2025-05-20；第 2 版）", "en": "Current PMDA Japan electronic label (20 May 2025; version 2)" }, "dosageForm": { "zh": "クラビット（CRAVIT）左氧氟沙星水合物 500 mg 口服片", "en": "CRAVIT levofloxacin hydrate 500 mg oral tablet" }, "route": { "zh": "口服（日本当前产品身份字段）", "en": "oral (current Japan product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "6241013F3027", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片以左氧氟沙星计 500 mg；PTP 100 片（5 片×20）（日本当前标签）", "en": "500 mg levofloxacin per tablet; 100-tablet PTP pack (5 × 20) (current Japan label)" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "左氧氟沙星（以左氧氟沙星水合物计）", "en": "levofloxacin (as levofloxacin hydrate)" }, "value": 500, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片日本当前标签标示量；不是个人片数、频率或疗程", "en": "current Japan labelled amount per tablet; not an individual tablet count, frequency or course" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": null, "package": { "count": 100, "unit": { "zh": "片/包装", "en": "tablets per pack" } }, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_fa1bb1e9b9a9d12d", "label": "PMDA：クラビット片 250 mg／500 mg、细粒 10% 日本当前电子说明书（2025-05-20；包装项目）", "url": "https://www.pmda.go.jp/PmdaSearch/iyakuDetail/ResultDataSetPDF/430574_6241013C2024_1_24", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "jp-cravit-tablet-500mg-500-ptp-current-2025", "marketCode": "JP", "labelVersion": { "zh": "PMDA 日本当前电子说明书（2025-05-20；第 2 版）", "en": "Current PMDA Japan electronic label (20 May 2025; version 2)" }, "dosageForm": { "zh": "クラビット（CRAVIT）左氧氟沙星水合物 500 mg 口服片", "en": "CRAVIT levofloxacin hydrate 500 mg oral tablet" }, "route": { "zh": "口服（日本当前产品身份字段）", "en": "oral (current Japan product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "6241013F3027", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片以左氧氟沙星计 500 mg；PTP 500 片（5 片×100）（日本当前标签）", "en": "500 mg levofloxacin per tablet; 500-tablet PTP pack (5 × 100) (current Japan label)" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "左氧氟沙星（以左氧氟沙星水合物计）", "en": "levofloxacin (as levofloxacin hydrate)" }, "value": 500, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片日本当前标签标示量；不是个人片数、频率或疗程", "en": "current Japan labelled amount per tablet; not an individual tablet count, frequency or course" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": null, "package": { "count": 500, "unit": { "zh": "片/包装", "en": "tablets per pack" } }, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_fa1bb1e9b9a9d12d", "label": "PMDA：クラビット片 250 mg／500 mg、细粒 10% 日本当前电子说明书（2025-05-20；包装项目）", "url": "https://www.pmda.go.jp/PmdaSearch/iyakuDetail/ResultDataSetPDF/430574_6241013C2024_1_24", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "jp-cravit-fine-granules-10pct-100g-bottle-current-2025", "marketCode": "JP", "labelVersion": { "zh": "PMDA 日本当前电子说明书（2025-05-20；第 2 版）", "en": "Current PMDA Japan electronic label (20 May 2025; version 2)" }, "dosageForm": { "zh": "クラビット（CRAVIT）左氧氟沙星水合物 10% 细粒", "en": "CRAVIT levofloxacin hydrate 10% fine granules" }, "route": { "zh": "口服（日本当前产品身份字段）", "en": "oral (current Japan product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "6241013C2024", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_g", "primaryDisplay": { "zh": "每 1 g 细粒以左氧氟沙星计 100 mg（10%）；100 g 塑料瓶（日本当前标签）", "en": "100 mg levofloxacin per 1 g of fine granules (10%); 100 g plastic bottle (current Japan label)" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "左氧氟沙星（以左氧氟沙星水合物计）", "en": "levofloxacin (as levofloxacin hydrate)" }, "value": 100, "unit": "mg", "basisCode": "per_g", "basisLabel": { "zh": "每 1 g 细粒日本当前标签标示量；不是个人克数、分包数、频率或疗程", "en": "current Japan labelled amount per 1 g of granules; not an individual gram amount, sachet count, frequency or course" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": null, "package": { "count": 100, "unit": { "zh": "g/瓶", "en": "g per bottle" } }, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_fa1bb1e9b9a9d12d", "label": "PMDA：クラビット片 250 mg／500 mg、细粒 10% 日本当前电子说明书（2025-05-20；包装项目）", "url": "https://www.pmda.go.jp/PmdaSearch/iyakuDetail/ResultDataSetPDF/430574_6241013C2024_1_24", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "jp-cravit-fine-granules-10pct-2-5g-100-sachets-current-2025", "marketCode": "JP", "labelVersion": { "zh": "PMDA 日本当前电子说明书（2025-05-20；第 2 版）", "en": "Current PMDA Japan electronic label (20 May 2025; version 2)" }, "dosageForm": { "zh": "クラビット（CRAVIT）左氧氟沙星水合物 10% 细粒", "en": "CRAVIT levofloxacin hydrate 10% fine granules" }, "route": { "zh": "口服（日本当前产品身份字段）", "en": "oral (current Japan product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "6241013C2024", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_g", "primaryDisplay": { "zh": "每 1 g 细粒以左氧氟沙星计 100 mg（10%）；2.5 g×100 包（日本当前标签）", "en": "100 mg levofloxacin per 1 g of fine granules (10%); 100 sachets of 2.5 g (current Japan label)" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "左氧氟沙星（以左氧氟沙星水合物计）", "en": "levofloxacin (as levofloxacin hydrate)" }, "value": 100, "unit": "mg", "basisCode": "per_g", "basisLabel": { "zh": "每 1 g 细粒日本当前标签标示量；不是个人克数、分包数、频率或疗程", "en": "current Japan labelled amount per 1 g of granules; not an individual gram amount, sachet count, frequency or course" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": null, "package": { "count": 100, "unit": { "zh": "包/盒", "en": "sachets per box" } }, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_fa1bb1e9b9a9d12d", "label": "PMDA：クラビット片 250 mg／500 mg、细粒 10% 日本当前电子说明书（2025-05-20；包装项目）", "url": "https://www.pmda.go.jp/PmdaSearch/iyakuDetail/ResultDataSetPDF/430574_6241013C2024_1_24", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-levaquin-tablet-250mg-ndc-50458-920-50-historical-2019", "marketCode": "US", "labelVersion": { "zh": "FDA 美国历史口服片标签（2019-05；非现行包装或供应结论）", "en": "FDA U.S. historical oral-tablet label (May 2019; not a current-package or availability finding)" }, "dosageForm": { "zh": "左氧氟沙星胶囊形薄膜衣口服片", "en": "levofloxacin capsule-shaped coated oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 50458-920-50", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片 250 mg；50 片瓶装（美国历史标签）", "en": "250 mg per tablet; 50-tablet bottle (U.S. historical label)" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "左氧氟沙星", "en": "levofloxacin" }, "value": 250, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片历史标签标示量", "en": "historical labelled amount per tablet" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": null, "package": { "count": 50, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "赤陶粉红色", "en": "terra cotta pink" }, "shape": { "zh": "胶囊形薄膜衣片", "en": "capsule-shaped coated tablet" }, "imprint": "LEVAQUIN / 250", "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_4e39fcca7a55ea86", "label": "FDA：LEVAQUIN 250 mg 口服片、50 片瓶装（NDC 50458-920-50；2019 美国历史标签）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020634s072lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-09-13", "reviewedAt": "2026-09-13" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-levaquin-tablet-500mg-ndc-50458-925-50-historical-2019", "marketCode": "US", "labelVersion": { "zh": "FDA 美国历史口服片标签（2019-05；非现行包装或供应结论）", "en": "FDA U.S. historical oral-tablet label (May 2019; not a current-package or availability finding)" }, "dosageForm": { "zh": "左氧氟沙星胶囊形薄膜衣口服片", "en": "levofloxacin capsule-shaped coated oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 50458-925-50", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片 500 mg；50 片瓶装（美国历史标签）", "en": "500 mg per tablet; 50-tablet bottle (U.S. historical label)" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "左氧氟沙星", "en": "levofloxacin" }, "value": 500, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片历史标签标示量", "en": "historical labelled amount per tablet" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": null, "package": { "count": 50, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "桃色", "en": "peach" }, "shape": { "zh": "胶囊形薄膜衣片", "en": "capsule-shaped coated tablet" }, "imprint": "LEVAQUIN / 500", "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_4e39fcca7a55ea86", "label": "FDA：LEVAQUIN 500 mg 口服片、50 片瓶装（NDC 50458-925-50；2019 美国历史标签）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020634s072lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-09-13", "reviewedAt": "2026-09-13" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-levaquin-tablet-750mg-ndc-50458-930-20-historical-2019", "marketCode": "US", "labelVersion": { "zh": "FDA 美国历史口服片标签（2019-05；非现行包装或供应结论）", "en": "FDA U.S. historical oral-tablet label (May 2019; not a current-package or availability finding)" }, "dosageForm": { "zh": "左氧氟沙星胶囊形薄膜衣口服片", "en": "levofloxacin capsule-shaped coated oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 50458-930-20", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片 750 mg；20 片瓶装（美国历史标签）", "en": "750 mg per tablet; 20-tablet bottle (U.S. historical label)" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "左氧氟沙星", "en": "levofloxacin" }, "value": 750, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片历史标签标示量", "en": "historical labelled amount per tablet" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": null, "package": { "count": 20, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "白色", "en": "white" }, "shape": { "zh": "胶囊形薄膜衣片", "en": "capsule-shaped coated tablet" }, "imprint": "LEVAQUIN / 750", "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_4e39fcca7a55ea86", "label": "FDA：LEVAQUIN 750 mg 口服片、20 片瓶装（NDC 50458-930-20；2019 美国历史标签）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020634s072lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-09-13", "reviewedAt": "2026-09-13" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "cn-cravit-levofloxacin-tablet-100mg-10tablet-blister-h20000655-historical-2021", "marketCode": "CN", "labelVersion": { "zh": "第一三共中国历史公开完整说明书（2021-05 修订；非现行批准、供应或包装结论）", "en": "Daiichi Sankyo China historical public full leaflet (revised May 2021; not a current approval, supply or pack finding)" }, "dosageForm": { "zh": "左氧氟沙星片", "en": "levofloxacin tablet" }, "route": { "zh": "口服（历史说明书产品身份字段）", "en": "oral (historical-leaflet product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "H20000655", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "可乐必妥® 左氧氟沙星片：每片 0.1 g（100 mg），10 片铝塑板/盒（中国历史说明书）", "en": "CRAVIT® levofloxacin tablets: 0.1 g (100 mg) per tablet, 10-tablet blister/box (China historical leaflet)" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "左氧氟沙星", "en": "levofloxacin" }, "value": 100, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片历史说明书标示量；不是个人片数或换算", "en": "historical leaflet amount per tablet; not an individual tablet count or conversion" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": null, "package": { "count": 10, "unit": { "zh": "片/铝塑板/盒", "en": "tablets per blister/box" } }, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_5a8b4df02f34aa4c", "label": "第一三共中国：可乐必妥® 左氧氟沙星片 0.1 g、10 片铝塑板/盒（国药准字 H20000655；2021 历史完整说明书）", "url": "https://www.daiichisankyo.com.cn/data/upload/file/20211112/6377230695728340551675231.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "first_party_leaflet", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "cn-cravit-levofloxacin-tablet-100mg-6tablet-blister-h20000655-historical-2021", "marketCode": "CN", "labelVersion": { "zh": "第一三共中国历史公开完整说明书（2021-05 修订；非现行批准、供应或包装结论）", "en": "Daiichi Sankyo China historical public full leaflet (revised May 2021; not a current approval, supply or pack finding)" }, "dosageForm": { "zh": "左氧氟沙星片", "en": "levofloxacin tablet" }, "route": { "zh": "口服（历史说明书产品身份字段）", "en": "oral (historical-leaflet product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "H20000655", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "可乐必妥® 左氧氟沙星片：每片 0.1 g（100 mg），6 片铝塑板/盒（中国历史说明书）", "en": "CRAVIT® levofloxacin tablets: 0.1 g (100 mg) per tablet, 6-tablet blister/box (China historical leaflet)" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "左氧氟沙星", "en": "levofloxacin" }, "value": 100, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片历史说明书标示量；不是个人片数或换算", "en": "historical leaflet amount per tablet; not an individual tablet count or conversion" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": null, "package": { "count": 6, "unit": { "zh": "片/铝塑板/盒", "en": "tablets per blister/box" } }, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_5a8b4df02f34aa4c", "label": "第一三共中国：可乐必妥® 左氧氟沙星片 0.1 g、6 片铝塑板/盒（国药准字 H20000655；2021 历史完整说明书）", "url": "https://www.daiichisankyo.com.cn/data/upload/file/20211112/6377230695728340551675231.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "first_party_leaflet", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "cn-cravit-levofloxacin-tablet-500mg-4tablet-blister-h20040091-historical-2021", "marketCode": "CN", "labelVersion": { "zh": "第一三共中国历史公开完整说明书（2021-04 修订；非现行批准、供应或包装结论）", "en": "Daiichi Sankyo China historical public full leaflet (revised Apr 2021; not a current approval, supply or pack finding)" }, "dosageForm": { "zh": "左氧氟沙星片", "en": "levofloxacin tablet" }, "route": { "zh": "口服（历史说明书产品身份字段）", "en": "oral (historical-leaflet product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "H20040091", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "可乐必妥® 左氧氟沙星片：每片 0.5 g（500 mg），4 片铝塑板/盒（中国历史说明书）", "en": "CRAVIT® levofloxacin tablets: 0.5 g (500 mg) per tablet, 4-tablet blister/box (China historical leaflet)" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "左氧氟沙星", "en": "levofloxacin" }, "value": 500, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片历史说明书标示量；不是个人片数或换算", "en": "historical leaflet amount per tablet; not an individual tablet count or conversion" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": null, "package": { "count": 4, "unit": { "zh": "片/铝塑板/盒", "en": "tablets per blister/box" } }, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_d26a8d5125a9c09d", "label": "第一三共中国：可乐必妥® 左氧氟沙星片 0.5 g、4 片铝塑板/盒（国药准字 H20040091；2021 历史完整说明书）", "url": "https://www.daiichisankyo.com.cn/data/upload/file/20211112/6377230777353626337639593.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "first_party_leaflet", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [ { "id": "jp-cravit-tablet-250mg-pmda-patient-guide-2025", "marketCode": "JP", "visualKind": "official_patient_guide_dosage_form_appearance", "title": { "zh": "CRAVIT 250 mg 片：日本官方剂型外观", "en": "CRAVIT 250 mg tablet: official Japan dosage-form appearance" }, "imageUrl": "/evidence/medicine/levaquin/cravit-tablet-250mg-pmda-patient-guide-2025.jpg", "alt": { "zh": "PMDA 患者用药指南中的 CRAVIT 250 mg 片和 PTP 泡罩外观", "en": "CRAVIT 250 mg tablet and PTP blister appearance in the PMDA patient medicine guide" }, "description": { "zh": "患者指南第 7 页所示橙色椭圆形 250 mg 片与 PTP 泡罩；仅对应日本该指南。", "en": "Orange oval 250 mg tablet and PTP blister shown on page 7 of the patient guide; Japan guide only." }, "exclusions": { "zh": "不是精确整盒包装图，也不是中国或美国包装；不能单凭外观判断真伪或决定用量。", "en": "Not an exact outer-package image and not a China or U.S. pack; appearance alone cannot authenticate the product or determine use." }, "source": { "id": "src_a2d8ff3f32ae1d1b", "label": "PMDA：クラビット片 250 mg／500 mg、细粒 10% 患者用医药品指南（2025-06-26；第 7 页外观）", "url": "https://www.info.pmda.go.jp/downfiles/ph/GUI/430574_6241013C2024_1_00G.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-24", "reviewedAt": "2026-08-24" }, "scope": "official_dosage_form_appearance_only_not_outer_package_authentication_or_personal_use" }, { "id": "jp-cravit-tablet-500mg-pmda-patient-guide-2025", "marketCode": "JP", "visualKind": "official_patient_guide_dosage_form_appearance", "title": { "zh": "CRAVIT 500 mg 片：日本官方剂型外观", "en": "CRAVIT 500 mg tablet: official Japan dosage-form appearance" }, "imageUrl": "/evidence/medicine/levaquin/cravit-tablet-500mg-pmda-patient-guide-2025.jpg", "alt": { "zh": "PMDA 患者用药指南中的 CRAVIT 500 mg 片和 PTP 泡罩外观", "en": "CRAVIT 500 mg tablet and PTP blister appearance in the PMDA patient medicine guide" }, "description": { "zh": "患者指南第 7 页所示淡橙色椭圆形 500 mg 片与 PTP 泡罩；仅对应日本该指南。", "en": "Pale-orange oval 500 mg tablet and PTP blister shown on page 7 of the patient guide; Japan guide only." }, "exclusions": { "zh": "不是精确整盒包装图，也不是中国或美国包装；250 mg 与 500 mg 外观不可混认。", "en": "Not an exact outer-package image and not a China or U.S. pack; the 250 mg and 500 mg appearances must not be confused." }, "source": { "id": "src_a2d8ff3f32ae1d1b", "label": "PMDA：クラビット片 250 mg／500 mg、细粒 10% 患者用医药品指南（2025-06-26；第 7 页外观）", "url": "https://www.info.pmda.go.jp/downfiles/ph/GUI/430574_6241013C2024_1_00G.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-24", "reviewedAt": "2026-08-24" }, "scope": "official_dosage_form_appearance_only_not_outer_package_authentication_or_personal_use" }, { "id": "jp-cravit-fine-granules-10pct-pmda-patient-guide-2025", "marketCode": "JP", "visualKind": "official_patient_guide_dosage_form_appearance", "title": { "zh": "CRAVIT 10% 细粒：日本官方分包外观", "en": "CRAVIT 10% fine granules: official Japan sachet appearance" }, "imageUrl": "/evidence/medicine/levaquin/cravit-fine-granules-10pct-pmda-patient-guide-2025.jpg", "alt": { "zh": "PMDA 患者用药指南中的 CRAVIT 10% 细粒 2.5 g 分包正反面", "en": "Front and back of the CRAVIT 10% fine-granule 2.5 g sachet in the PMDA patient medicine guide" }, "description": { "zh": "患者指南第 7 页所示 10% 细粒 2.5 g 分包正反面；仅对应日本该指南。", "en": "Front and back of the 2.5 g sachet of 10% fine granules shown on page 7; Japan guide only." }, "exclusions": { "zh": "分包上的 250 mg/包与 2.5 g 是产品身份字段，不是个人服用量或疗程指令。", "en": "The sachet's 250 mg per packet and 2.5 g are product-identity fields, not an individual amount or course instruction." }, "source": { "id": "src_a2d8ff3f32ae1d1b", "label": "PMDA：クラビット片 250 mg／500 mg、细粒 10% 患者用医药品指南（2025-06-26；第 7 页外观）", "url": "https://www.info.pmda.go.jp/downfiles/ph/GUI/430574_6241013C2024_1_00G.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-24", "reviewedAt": "2026-08-24" }, "scope": "official_dosage_form_appearance_only_not_outer_package_authentication_or_personal_use" } ], "visualReference": { "status": "withheld_repackaged_or_non_exact_visual", "title": { "zh": "再包装历史标签不作为原品牌整盒图；日本官方剂型外观已单列", "en": "The repackaged historical label is not an original-brand outer package; official Japan dosage-form appearances are shown separately" }, "summary": { "zh": "DailyMed 可检索到的 LEVAQUIN 相关可见标签由 RedPharm Drug Inc. 标为再包装标签，不能被当作原品牌整盒包装图。页面因此仍不展示 LEVAQUIN、可乐必妥或 CRAVIT 的精确整盒包装；另设模块展示 PMDA 2025-06-26 患者指南中的日本 CRAVIT 250 mg 片、500 mg 片和 10% 细粒剂型外观，并明确不外推为中国或美国包装、真伪证明或个人用量。", "en": "The searchable DailyMed LEVAQUIN label is identified by RedPharm Drug Inc. as repackaged and cannot serve as an original-brand outer-package image. Exact LEVAQUIN, CRAVIT or 可乐必妥 outer packages therefore remain withheld. A separate module shows Japan-only CRAVIT 250 mg tablet, 500 mg tablet and 10% fine-granule dosage-form appearances from the PMDA patient guide dated 26 June 2025; they are not China or U.S. packs, authentication evidence or individual-use instructions." }, "source": { "id": "src_82d58501060b81b5", "label": "DailyMed（NLM）：LEVAQUIN 再包装历史标签说明", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=40a96527-f89e-4177-9224-5c79167f3e60", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "CRAVIT / 可乐必妥 / LEVAQUIN 说明书放大阅读：先确认市场、剂型与规格", "en": "CRAVIT / LEVAQUIN label reading: first confirm market, dosage form and strength" }, "summary": { "zh": "本模块首先链接 PMDA 2025-06 更新的日本 CRAVIT 患者用药指南：其首页并列 250 mg、500 mg 片和 10% 细粒，并标示左氧氟沙星水合物；美国 2019 年 LEVAQUIN 口服片历史标签仍作为另一个市场的阅读文件保留。两份文件都只帮助核对名称、剂型、强度和警告文字，不能判断感染是否需要抗菌药，也不把包装数字转换为个人的片数、疗程或换药方案。", "en": "This module first links the PMDA Japan CRAVIT patient medication guide, updated in June 2025. Its first page separately identifies 250 mg and 500 mg tablets and 10% fine granules as levofloxacin hydrate; the 2019 U.S. LEVAQUIN oral-tablet archive remains a reading document for a different market. Neither document decides whether an infection needs an antibacterial medicine or converts package numbers into a personal tablet count, course or switching plan." }, "checks": [ { "zh": "先核对包装上的完整品牌名：日本常见 CRAVIT、中国历史资料为可乐必妥®、美国历史标签为 LEVAQUIN，欧洲品牌历史线索为 TAVANIC；再核对左氧氟沙星、剂型、每单位标示强度和目标市场。品牌族谱不表示不同市场产品可自行互换。", "en": "First check the complete pack brand: CRAVIT in Japan, 可乐必妥® in the historical China material, LEVAQUIN in the U.S. historical label and TAVANIC as a European brand-history cue; then check levofloxacin, dosage form, stated strength per unit and target market. A brand family does not make products from different markets self-interchangeable." }, { "zh": "PMDA 2025-05 电子说明书的包装项目分别列出：250 mg 片的 100 片瓶装、PTP 100/500 片；500 mg 片的 100 片瓶装、PTP 50/100/500 片；10% 细粒的 100 g 瓶装及 2.5 g×100 包。包装总量、每片强度与细粒每 1 g 含量是不同字段，不能据此推导个人片数、克数、包数或疗程。", "en": "The May 2025 PMDA electronic label separately lists 250 mg tablets in a 100-tablet bottle and 100/500-tablet PTP packs; 500 mg tablets in a 100-tablet bottle and 50/100/500-tablet PTP packs; and 10% fine granules in a 100 g bottle or 100 sachets of 2.5 g. Total pack amount, per-tablet strength and amount per 1 g of granules are different fields and do not derive an individual's tablet, gram or sachet count or course." }, { "zh": "250、500、750 mg 首先是标签所列每片的标示强度，不是“今天应吃几片”的答案。片数、剩余药量、症状轻重或他人的处方都不能让读者自行把不同强度拼量、减半、替换或延长疗程。", "en": "250, 500 and 750 mg first identify the labelled strength per tablet; they are not an answer to “how many tablets today.” Tablet count, leftovers, symptom severity or someone else’s prescription do not permit self-combining strengths, halving, substituting or extending a course." }, { "zh": "PMDA 现行电子说明书与 FDA 历史标签均含严重不良反应警示。若出现突发或持续的腹部、胸部或背部疼痛，或肌腱疼痛/肿胀、麻木刺痛、明显情绪或意识变化、严重低血糖样不适、呼吸困难等，应立即使用当地紧急医疗支持；不要等待网页判断、继续使用或自行改成另一种抗菌药。", "en": "The current PMDA electronic label and historical FDA label both contain serious adverse-reaction warnings. With sudden or persistent abdominal, chest or back pain, tendon pain or swelling, numbness or tingling, marked mood or mental-status change, severe low-glucose-like symptoms, breathing trouble or a similar concern, use local urgent medical support immediately; do not wait for a website decision, continue, or self-switch to another antibacterial medicine." }, { "zh": "PMDA 现行电子说明书提示老年人更易出现肌腱障碍，且常伴肾功能下降；同时使用口服或注射糖皮质激素时，肌腱风险还可能增加。网页不能据此计算任何人的片数、间隔或疗程；请把年龄、肾功能资料、激素用药及完整药单交给开方医生或药师核对。", "en": "The current PMDA electronic label notes that older adults are more prone to tendon disorders and often have reduced renal function; oral or injected corticosteroids may further increase tendon risk. A website cannot calculate any person's tablet count, interval or course from this. Have the prescriber or pharmacist review age, renal information, corticosteroid use and the complete medicine list." }, { "zh": "抗菌药的适用性、给药途径与疗程必须由具体感染、检测资料、个人状况和目标市场现行标签共同决定。正在使用降糖药、抗凝药、抗心律失常药、矿物质补充剂或多种处方/非处方产品时，应带完整药单和实际包装请医生或药师核对；网页不能判断个人能否联用、换药或调整。", "en": "Whether an antibacterial medicine is appropriate, which route is used and how long it is used must be determined from the specific infection, testing, individual circumstances and the current target-market label. With glucose medicines, anticoagulants, antiarrhythmics, mineral supplements or multiple prescription/OTC products, bring the full medicine list and actual pack for clinician or pharmacist review; a webpage cannot decide individual combination, switching or adjustment." }, { "zh": "第一三共面向公众的“用药说明辅助资料”官方目录把 CRAVIT 250 mg 片、500 mg 片和 10% 细粒列为三条独立入口。本页同时保留这一官方目录和 PMDA 患者用药指南，方便放大阅读；三种产品不能互相代替，也不能把片剂的每片 mg、细粒的每 1 g 含量或包装数量换算成个人用量。", "en": "Daiichi Sankyo's official public patient-information directory exposes separate entries for CRAVIT 250 mg tablets, 500 mg tablets and 10% fine granules. This record retains that official directory together with the PMDA patient guide for enlarged reading. The three products do not replace one another or convert tablet strength, amount per gram of granules or package count into an individual amount to use." } ], "source": { "id": "src_a2d8ff3f32ae1d1b", "label": "PMDA：クラビット片 250 mg／500 mg、细粒 10% 患者用医药品指南（2025-06 更新；日本公开资料）", "url": "https://www.info.pmda.go.jp/downfiles/ph/GUI/430574_6241013C2024_1_00G.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-24", "reviewedAt": "2026-08-24" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "左氧氟沙星怎样起作用：它干扰细菌复制 DNA 所需的两种酶", "en": "How levofloxacin works: it interferes with two enzymes needed for bacterial DNA replication" }, "summary": { "zh": "FDA 2019 公开标签描述左氧氟沙星可抑制细菌的 DNA 旋转酶和拓扑异构酶 IV；这两种 II 型拓扑异构酶与细菌 DNA 的复制、转录、修复和重组有关。这一机制不能判断某种症状是否为细菌感染，也不能选择抗菌药、途径或疗程。", "en": "The 2019 FDA public label describes levofloxacin as inhibiting bacterial DNA gyrase and topoisomerase IV. These type II topoisomerases are involved in bacterial DNA replication, transcription, repair and recombination. This mechanism cannot determine whether symptoms are a bacterial infection or choose an antibacterial medicine, route or course." }, "checks": [ { "zh": "“影响细菌 DNA”不是感染诊断或选药结论。是否需要抗菌药，仍须由具体感染、检查资料、个人状况和目标市场的现行标签共同判断。", "en": "“Affecting bacterial DNA” is not a diagnosis of infection or a medicine-selection conclusion. Whether an antibacterial medicine is needed still depends on the specific infection, testing, individual circumstances and the current target-market label." }, { "zh": "共同机制不使 250、500、750 mg 口服片可自行换算、拼量或替代，也不使口服液或静脉制剂可从本页推导。产品身份、给药途径、强度和现行处方必须分别核对。", "en": "A shared mechanism does not make 250, 500 or 750 mg oral tablets self-convertible, combinable or substitutable, and does not derive oral solution or intravenous products from this page. Product identity, route, strength and current prescription must each be checked separately." }, { "zh": "机制页面也不能决定联用、换药、停用或疗程长短。正在使用多种药物、出现不适或考虑改变方案时，应带上实际包装和完整药单请医生或药师复核。", "en": "A mechanism page also cannot decide combination, switching, stopping or course length. With multiple medicines, symptoms or a contemplated change, take the actual pack and complete medicine list to a clinician or pharmacist for review." } ], "source": { "id": "src_4e39fcca7a55ea86", "label": "FDA：LEVAQUIN 2019 美国口服片处方信息（临床药理）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020634s072lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-09-13", "reviewedAt": "2026-09-13" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "Levaquin", "generic": "左氧氟沙星", "dosageFormClass": "日本 PMDA：250 mg、500 mg 片及 10% 细粒；美国历史标签：250 mg、500 mg、750 mg 口服片；中国大陆 2021 年历史完整说明书：0.1 g、0.5 g 口服片（市场与版本须分别核对）" }, "labelSource": { "id": "src_a2d8ff3f32ae1d1b", "label": "PMDA：クラビット片 250 mg／500 mg、细粒 10% 患者用医药品指南（2025-06 更新；日本公开资料）", "url": "https://www.info.pmda.go.jp/downfiles/ph/GUI/430574_6241013C2024_1_00G.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-24", "reviewedAt": "2026-08-24" }, "productRoutes": [ { "source": { "id": "src_a2d8ff3f32ae1d1b", "label": "PMDA：クラビット片 250 mg／500 mg、细粒 10% 患者用医药品指南（2025-06 更新；日本公开资料）", "url": "https://www.info.pmda.go.jp/downfiles/ph/GUI/430574_6241013C2024_1_00G.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-24", "reviewedAt": "2026-08-24" }, "status": "product_level_public_record_verified", "authority": { "zh": "PMDA", "en": "PMDA" }, "market": { "zh": "日本", "en": "Japan" }, "recordType": { "zh": "监管产品记录", "en": "Regulatory product record" }, "reviewedAt": "2026-08-24", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_c4a454dbd8713307", "label": "PMDA：クラビット片 250 mg／500 mg及细粒 10% 当前产品页", "url": "https://www.pmda.go.jp/PmdaSearch/rdDetail/iyaku/6241013C2024_1?user=1", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "status": "product_level_public_record_verified", "authority": { "zh": "PMDA", "en": "PMDA" }, "market": { "zh": "日本", "en": "Japan" }, "recordType": { "zh": "监管产品记录", "en": "Regulatory product record" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_fa1bb1e9b9a9d12d", "label": "PMDA：クラビット片 250 mg／500 mg、细粒 10% 当前电子说明书（2025-05-20；包装项目）", "url": "https://www.pmda.go.jp/PmdaSearch/iyakuDetail/ResultDataSetPDF/430574_6241013C2024_1_24", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "status": "product_level_public_record_verified", "authority": { "zh": "PMDA", "en": "PMDA" }, "market": { "zh": "日本", "en": "Japan" }, "recordType": { "zh": "监管产品记录", "en": "Regulatory product record" }, "reviewedAt": "2026-08-30", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_c5a4566ed971349a", "label": "PMDA：クラビット片 250 mg／500 mg及细粒 10% 面向公众产品页", "url": "https://www.pmda.go.jp/PmdaSearch/rdDetail/iyaku/6241013C2024_1?user=2", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "status": "product_level_public_record_verified", "authority": { "zh": "PMDA", "en": "PMDA" }, "market": { "zh": "日本", "en": "Japan" }, "recordType": { "zh": "监管产品记录", "en": "Regulatory product record" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_4e39fcca7a55ea86", "label": "FDA：LEVAQUIN 2019 美国口服片处方信息（NDA 020634）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020634s072lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-09-13", "reviewedAt": "2026-09-13" }, "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-09-13", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_5a8b4df02f34aa4c", "label": "第一三共中国：可乐必妥® 左氧氟沙星片 0.1 g 说明书（2021，历史公开资料）", "url": "https://www.daiichisankyo.com.cn/data/upload/file/20211112/6377230695728340551675231.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "first_party_leaflet", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "status": "manufacturer_public_label_verified", "authority": { "zh": "第一三共中国", "en": "Daiichi Sankyo China" }, "market": { "zh": "中国大陆", "en": "Mainland China" }, "recordType": { "zh": "企业公开说明书", "en": "Manufacturer public leaflet" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_d26a8d5125a9c09d", "label": "第一三共中国：可乐必妥® 左氧氟沙星片 0.5 g 完整说明书（2021，历史公开资料）", "url": "https://www.daiichisankyo.com.cn/data/upload/file/20211112/6377230777353626337639593.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "first_party_leaflet", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "status": "manufacturer_public_label_verified", "authority": { "zh": "第一三共中国", "en": "Daiichi Sankyo China" }, "market": { "zh": "中国大陆", "en": "Mainland China" }, "recordType": { "zh": "企业公开说明书", "en": "Manufacturer public leaflet" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "PMDA", "en": "PMDA" }, "market": { "zh": "日本", "en": "Japan" }, "recordType": { "zh": "监管产品记录", "en": "Regulatory product record" }, "reviewedAt": "2026-08-24", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [ { "id": "who-2006-levaquin-injection-quality-alert", "issuedAt": "2006-11-28", "status": "historical_specific_product_quality_alert", "title": { "zh": "WHO 历史质量警示：特定 Levaquin 注射液批次与非正规渠道风险", "en": "WHO historical quality alert: specific LEVAQUIN injection batches and unauthorised-channel risk" }, "summary": { "zh": "该通知仅涉及 2006 年标示为 Levaquin（左氧氟沙星）注射液 25 mg/mL、20 mL 小瓶的两个特定批次及其非正规流通和储存风险；不适用于本档案中的口服片、日本 CRAVIT 或任何当前产品状态结论。", "en": "This notice concerns only two named 2006 batches of LEVAQUIN (levofloxacin) injection 25 mg/mL in 20 mL vials and their unauthorised distribution/storage risk. It does not apply to this dossier’s oral tablets, Japanese CRAVIT, or any current product-status conclusion." }, "source": { "id": "src_3817337418500658", "label": "WHO：2006-11-28 Levaquin injection quality and safety notice", "url": "https://cdn.who.int/media/docs/default-source/pvg/drug-alerts/da112---alert-112.pdf?sfvrsn=b5816e9c_6", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-2013-systemic-fluoroquinolone-peripheral-neuropathy-label-change", "issuedAt": "2013-08-15", "status": "fda_class_safety_communication", "title": { "zh": "FDA 药物安全通讯：全身用氟喹诺酮类的周围神经病变标签更新", "en": "FDA Drug Safety Communication: peripheral-neuropathy label updates for systemic fluoroquinolones" }, "summary": { "zh": "FDA 于 2013-08-15 发布药物安全通讯，要求全身用（口服或注射）氟喹诺酮类的说明书和患者用药指南更清楚说明周围神经病变风险；公告明确列出 Levaquin、Cipro 和 Avelox，并说明该风险可在开始用药后不久出现且可能持续。本记录是特定日期的美国类别监管通讯，不把同类关系变成任何个人的停药、改药、剂型转换或症状归因结论；出现疼痛、灼热、麻刺、麻木、无力或感觉异常等急性或令人担忧的不适，应使用当地医疗支持并由专业人员核对实际产品与完整药单。", "en": "On 2013-08-15, FDA issued a Drug Safety Communication requiring clearer peripheral-neuropathy information in labels and Medication Guides for systemic (oral or injectable) fluoroquinolones. The notice explicitly lists Levaquin, Cipro and Avelox, and says this risk may occur soon after treatment starts and may persist. This is a dated U.S. class communication; it does not turn class membership into an individual stop, switch, dosage-form conversion or symptom-attribution conclusion. With acute or concerning pain, burning, tingling, numbness, weakness or altered sensation, use local medical support and have a professional check the actual product and complete medicine list." }, "source": { "id": "src_15292a025a5f8cfe", "label": "FDA：2013-08-15 全身用氟喹诺酮类周围神经病变标签更新药物安全通讯", "url": "https://www.fda.gov/media/86575/download", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "可乐必妥®、CRAVIT®、LEVAQUIN 与 TAVANIC 是左氧氟沙星在不同市场出现的品牌名称线索。第一三共官方资料记载其发现左氧氟沙星，并于 1993 年以 CRAVIT® 在日本上市；PMDA 当前电子说明书覆盖日本 CRAVIT 250 mg、500 mg 片和 10% 细粒，并逐项列出 9 种瓶装、PTP 与分包包装。美国 FDA 历史标签使用 LEVAQUIN，中国第一三共历史资料使用可乐必妥®。这些名称帮助找到同一活性成分的市场档案，但不同市场、剂型、规格、标签与包装必须分别核验。", "history": "第一三共一手资料把左氧氟沙星的研发起源和 1993 年日本 CRAVIT 上市连接起来，并在全球品牌说明中列出美国 LEVAQUIN 与欧洲 TAVANIC。中国第一三共历史文件把“可乐必妥®”列为左氧氟沙星片商品名。该品牌族谱只用于检索和阅读历史，不能把日本、美国、中国或欧洲的当前批准、持有人、供应、适应症与包装互相推定。DailyMed 可见 LEVAQUIN 图片属于再包装历史标签，故仍不作为原品牌包装展示。", "sourceDocuments": [ { "id": "src_bad8af583d79ad1c", "label": "第一三共：左氧氟沙星由其发现、1993 年以 CRAVIT 在日本上市（2011）", "url": "https://www.daiichisankyo.com/media/press_release/detail/index_3722.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "first_party_release", "market": "GLOBAL", "accessStatus": "public_access_with_site_controls", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_6fa55085e6582599", "label": "第一三共：左氧氟沙星全球品牌名与研发来源说明（2009）", "url": "https://www.daiichisankyo.com/media/press_release/detail/index_3886.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "first_party_release", "market": "GLOBAL", "accessStatus": "public_access_with_site_controls", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_c4a454dbd8713307", "label": "PMDA：クラビット片 250 mg／500 mg及细粒 10% 当前产品页", "url": "https://www.pmda.go.jp/PmdaSearch/rdDetail/iyaku/6241013C2024_1?user=1", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_fa1bb1e9b9a9d12d", "label": "PMDA：クラビット片 250 mg／500 mg、细粒 10% 当前电子说明书（2025-05-20；包装项目）", "url": "https://www.pmda.go.jp/PmdaSearch/iyakuDetail/ResultDataSetPDF/430574_6241013C2024_1_24", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, { "id": "src_87497e0d12a0afd1", "label": "日本厚生劳动省：クラビット片 250 mg／500 mg 当前药价基准收载代码（2026 目录）", "url": "https://www.mhlw.go.jp/topics/2026/04/dl/tp20260612-01_05.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_listing", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, { "id": "src_c5a4566ed971349a", "label": "PMDA：クラビット片 250 mg／500 mg及细粒 10% 面向公众产品页", "url": "https://www.pmda.go.jp/PmdaSearch/rdDetail/iyaku/6241013C2024_1?user=2", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_a2d8ff3f32ae1d1b", "label": "PMDA：クラビット片 250 mg／500 mg、细粒 10% 患者用医药品指南（2025-06 更新；日本公开资料）", "url": "https://www.info.pmda.go.jp/downfiles/ph/GUI/430574_6241013C2024_1_00G.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-24", "reviewedAt": "2026-08-24" }, { "id": "src_2398a2855b848769", "label": "第一三共日本：クラビット片 250 mg／500 mg、细粒 10% 患者辅助资料官方目录", "url": "https://www.daiichisankyo.co.jp/healthy/kusuri_shiori/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "first_party_product_page", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-31", "reviewedAt": "2026-08-31" }, { "id": "src_4e39fcca7a55ea86", "label": "FDA：LEVAQUIN 2019 美国口服片处方信息（NDA 020634）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020634s072lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-09-13", "reviewedAt": "2026-09-13" }, { "id": "src_5a8b4df02f34aa4c", "label": "第一三共中国：可乐必妥® 左氧氟沙星片 0.1 g 说明书（2021，历史公开资料）", "url": "https://www.daiichisankyo.com.cn/data/upload/file/20211112/6377230695728340551675231.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "first_party_leaflet", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_d26a8d5125a9c09d", "label": "第一三共中国：可乐必妥® 左氧氟沙星片 0.5 g 完整说明书（2021，历史公开资料）", "url": "https://www.daiichisankyo.com.cn/data/upload/file/20211112/6377230777353626337639593.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "first_party_leaflet", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_5ed30b676fbb9773", "label": "FDA Drugs@FDA 官方检索入口", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_lookup_entry", "documentKind": "regulatory_lookup", "market": "US", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } ], "applicationNumber": "NDA 020634", "approvalTimeline": [ { "date": "1993", "title": { "zh": "CRAVIT 在日本上市", "en": "CRAVIT launched in Japan" }, "detail": { "zh": "第一三共官方资料记载，左氧氟沙星由第一三共发现，并于 1993 年以 CRAVIT® 品牌在日本首次上市。这是研发与品牌历史证据，不替代任何市场的现行批准记录。", "en": "Daiichi Sankyo states that levofloxacin was originally discovered by the company and first launched in Japan in 1993 under the CRAVIT® brand. This is research and brand-history evidence, not a substitute for any current market approval record." }, "source": { "id": "src_bad8af583d79ad1c", "label": "第一三共：左氧氟沙星由其发现、1993 年以 CRAVIT 在日本上市（2011）", "url": "https://www.daiichisankyo.com/media/press_release/detail/index_3722.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "first_party_release", "market": "GLOBAL", "accessStatus": "public_access_with_site_controls", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, { "date": "1996", "title": { "zh": "FDA 标签所列美国初始批准年份", "en": "Initial U.S. approval year listed in the FDA label" }, "detail": { "zh": "本页链接的 FDA 标签档案列示 Initial U.S. Approval: 1996。该历史定位不等同于当前批准、可得性、持有人或其他市场状态。", "en": "The FDA label archive linked here lists Initial U.S. Approval: 1996. This historical locator is not a conclusion about current approval, availability, holder or another market." }, "source": { "id": "src_4e39fcca7a55ea86", "label": "FDA: LEVAQUIN oral-tablet label archive", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020634s072lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-09-13", "reviewedAt": "2026-09-13" } }, { "date": "2009", "title": { "zh": "全球品牌名称关系的一手说明", "en": "First-party account of global brand names" }, "detail": { "zh": "第一三共官方资料将美国品牌列为 LEVAQUIN、欧洲品牌列为 TAVANIC，并再次说明左氧氟沙星起源于第一三共。名称关系用于跨市场检索，不表示各市场的剂型、规格、标签或供应相同。", "en": "A Daiichi Sankyo release identifies LEVAQUIN as the U.S. brand and TAVANIC as the European brand and again states that levofloxacin originated at Daiichi Sankyo. The name relationship supports cross-market retrieval; it does not mean dosage forms, strengths, labels or supply are the same." }, "source": { "id": "src_6fa55085e6582599", "label": "第一三共：左氧氟沙星全球品牌名与研发来源说明（2009）", "url": "https://www.daiichisankyo.com/media/press_release/detail/index_3886.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "first_party_release", "market": "GLOBAL", "accessStatus": "public_access_with_site_controls", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, { "date": "2019", "title": { "zh": "FDA 标签档案版本", "en": "FDA label archive version" }, "detail": { "zh": "本页链接 2019 的 FDA 标签档案作为可复核阅读入口。现行标签、规格、适应症和安全信息必须另行以目标市场当前文件核对。", "en": "This page links the 2019 FDA label archive as a traceable reading entry point. Current labeling, strength, indication and safety information require separate verification against the target market’s current document." }, "source": { "id": "src_4e39fcca7a55ea86", "label": "FDA: LEVAQUIN oral-tablet label archive", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020634s072lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-09-13", "reviewedAt": "2026-09-13" } }, { "date": "2021-04", "title": { "zh": "第一三共中国历史公开 0.5 g 完整说明书", "en": "Daiichi Sankyo China historical full 0.5 g leaflet" }, "detail": { "zh": "第一三共中国公开的 2021 年完整说明书将可乐必妥®列为左氧氟沙星片商品名，并列出 0.5 g 片剂。这是可追溯的历史资料，不构成中国大陆当前批准、持有人、标签、供应、原研关系或可售资格结论。", "en": "A full Daiichi Sankyo China public leaflet from 2021 identifies 可乐必妥® as a trade name for levofloxacin tablets and lists a 0.5 g tablet. It is a traceable historical document, not a conclusion about current Mainland China approval, holder, labeling, supply, originator status or sale eligibility." }, "source": { "id": "src_d26a8d5125a9c09d", "label": "Daiichi Sankyo China: 可乐必妥® 0.5 g full historical leaflet (2021)", "url": "https://www.daiichisankyo.com.cn/data/upload/file/20211112/6377230777353626337639593.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "first_party_leaflet", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, { "date": "2021-05", "title": { "zh": "第一三共中国历史公开说明书", "en": "Daiichi Sankyo China historical public leaflet" }, "detail": { "zh": "第一三共中国公开的 2021 年说明书将可乐必妥®列为左氧氟沙星片商品名，并列出 0.1 g 片剂。这是可追溯的历史资料，不构成中国大陆当前批准、持有人、标签、供应、原研关系或可售资格结论。", "en": "A Daiichi Sankyo China public leaflet from 2021 identifies 可乐必妥® as a trade name for levofloxacin tablets and lists a 0.1 g tablet. It is a traceable historical document, not a conclusion about current Mainland China approval, holder, labeling, supply, originator status or sale eligibility." }, "source": { "id": "src_5a8b4df02f34aa4c", "label": "Daiichi Sankyo China: 可乐必妥® 0.1 g historical leaflet (2021)", "url": "https://www.daiichisankyo.com.cn/data/upload/file/20211112/6377230695728340551675231.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "first_party_leaflet", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, { "date": "2025-05", "title": { "zh": "PMDA 日本当前产品页", "en": "Current Japan PMDA product page" }, "detail": { "zh": "PMDA 产品页列示クラビット片 250 mg、500 mg及细粒 10%，通用名为左氧氟沙星水合物，制造销售方为第一三共。该记录只确认日本页面所列产品，不能外推至中国、美国或欧洲。", "en": "The PMDA product page lists CRAVIT 250 mg and 500 mg tablets and 10% fine granules, with levofloxacin hydrate as the non-proprietary name and Daiichi Sankyo as marketing authorisation holder. It confirms only the products listed for Japan and cannot be extrapolated to China, the United States or Europe." }, "source": { "id": "src_c4a454dbd8713307", "label": "PMDA：クラビット片 250 mg／500 mg及细粒 10% 当前产品页", "url": "https://www.pmda.go.jp/PmdaSearch/rdDetail/iyaku/6241013C2024_1?user=1", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } } ], "marketStatus": [ { "market": { "zh": "日本", "en": "Japan" }, "status": { "zh": "已链接 PMDA 当前产品页", "en": "Current PMDA product page linked" }, "detail": { "zh": "当前 PMDA 页面列示 CRAVIT 250 mg、500 mg 片和 10% 细粒，制造销售方为第一三共；仅对应日本页面所列产品。", "en": "The current PMDA page lists CRAVIT 250 mg and 500 mg tablets and 10% fine granules, with Daiichi Sankyo as marketing authorisation holder; this applies only to the products listed for Japan." } }, { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "已链接 FDA 历史口服片标签", "en": "FDA historical oral-tablet label linked" }, "detail": { "zh": "仅对应本页所列 2019 FDA 口服片文件。", "en": "Only the 2019 FDA oral-tablet document listed on this page is linked." } }, { "market": { "zh": "中国大陆", "en": "Mainland China" }, "status": { "zh": "已链接企业历史公开完整说明书；现行官方记录待核验", "en": "First-party historical full leaflets linked; current official record unverified" }, "detail": { "zh": "第一三共中国的 2021 年 0.5 g 与 0.1 g 历史完整说明书提供可乐必妥®片剂的可追溯阅读线索；不得据此推定现行批准、持有人、规格、供应或可售资格。", "en": "Daiichi Sankyo China full historical 0.5 g and 0.1 g leaflets from 2021 provide traceable reading cues for 可乐必妥® tablets; they do not establish current approval, holder, strength, supply or sale eligibility." } }, { "market": { "zh": "欧洲", "en": "Europe" }, "status": { "zh": "已建立 TAVANIC 品牌历史线索；现行国家记录待核验", "en": "TAVANIC brand-history cue established; current country records unverified" }, "detail": { "zh": "第一三共 2009 年资料列出欧洲品牌名 TAVANIC；未据此推定任何欧洲国家的现行批准、持有人、规格、供应或可售资格。", "en": "A 2009 Daiichi Sankyo release states the European brand name TAVANIC; it is not used to infer current approval, holder, strength, supply or sale eligibility in any European country." } }, { "market": { "zh": "其他市场", "en": "Other markets" }, "status": { "zh": "待逐项建立市场记录", "en": "Market record not established" }, "detail": { "zh": "不从日本、美国、中国或欧洲的文件推定其他市场状态。", "en": "No other-market status is inferred from Japanese, U.S., China or European material." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "为什么同一档案会出现 CRAVIT、可乐必妥、LEVAQUIN 和 TAVANIC？", "en": "Why does one record show CRAVIT, 可乐必妥, LEVAQUIN and TAVANIC?" }, "answer": { "zh": "它们是左氧氟沙星在不同市场出现的品牌名称线索：第一三共资料记录日本 CRAVIT、中国历史资料为可乐必妥®、美国为 LEVAQUIN、欧洲品牌历史线索为 TAVANIC。名称关系便于检索，不表示各市场的现行批准、规格、标签、包装、供应或可售状态相同。", "en": "They are market-specific brand-name cues for levofloxacin: Daiichi Sankyo material records CRAVIT in Japan, the historical China material uses 可乐必妥®, the U.S. brand is LEVAQUIN and the European brand-history cue is TAVANIC. The relationship supports retrieval; it does not mean current approvals, strengths, labels, packages, supply or sale eligibility are the same across markets." } } ], "relatedMedicineChecks": [ { "target": { "id": "coumadin", "brand": "Coumadin", "generic": "华法林钠", "canonicalUrls": { "zh": "https://origindrug.com/drugs/coumadin/", "en": "https://origindrug.com/en/drugs/coumadin/" } }, "title": { "zh": "与 COUMADIN／华法林同在药单上时：先核对 INR 与出血监测记录", "en": "When COUMADIN / warfarin is on the same list: review INR and bleeding-monitoring records first" }, "summary": { "zh": "FDA 的 2019 年 LEVAQUIN 美国历史口服片标签将华法林列为需要核对的药物，并提示上市后报告中出现华法林作用增强、凝血酶原时间或 INR 升高及出血事件。该文件同时明确可能不是 FDA 最新批准标签，因此这张卡只作有日期、美国、成分层面的优先核对提示：请把两种实际药盒、目标市场现行说明书、最近的监测记录以及所有处方药、非处方药和补充剂尽快交给开方团队、药师或抗凝管理团队复核。它不判断个人能否同用，不提供 INR 目标、片数、给药间隔或停换药方案，也不建议自行停用、错开时间、替换或调整任何一种药。", "en": "The FDA's 2019 historical U.S. oral-tablet label for LEVAQUIN lists warfarin as a medicine requiring review and describes postmarketing reports of enhanced warfarin effect, increased prothrombin time or INR, and bleeding episodes. The document also states that it may not be FDA's latest approved label. This card is therefore only a dated, U.S., ingredient-level priority-review cue: promptly take both actual packs, current target-market labels, recent monitoring records, and every prescription, OTC product and supplement to the prescribing team, pharmacist or anticoagulation service. It does not decide individual co-use, provide an INR target, tablet count, timing interval or stop/switch plan, or advise self-stopping, time-separation, replacement or adjustment of either medicine." }, "source": { "id": "src_4e39fcca7a55ea86", "label": "FDA：LEVAQUIN 2019 美国历史口服片标签（7.2 Warfarin；文件明确可能不是最新批准标签）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020634s072lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-09-13", "reviewedAt": "2026-09-13" }, "scope": "review_complete_medicine_list_no_self_directed_change" } ], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "how-to-read-a-drug-label", "regulatory-sources-first" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/levaquin/", "en": "https://origindrug.com/en/drugs/levaquin/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "avelox", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-25", "status": "published_traceable_archive" }, "names": { "brand": "Avelox", "generic": "莫西沙星", "aliases": [ "moxifloxacin", "moxifloxacin hydrochloride" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "感染", "sourceArchiveMarket": "美国 FDA 2020 历史公开标签档案：本页建立一张 400 mg、NDC 50419-530-01、30 片瓶装的文字身份卡；不代表当前包装、供应或其他市场状态", "dosageFormClass": "口服片剂：400 mg 莫西沙星（FDA 2020 标签所列；本页仅覆盖口服片）", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "1999（FDA 2020 标签所列美国初始批准）", "archiveSponsorText": "Bayer / FDA 公开历史标签档案" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-avelox-moxifloxacin-tablet-400mg-ndc-50419-530-01-30-bottle-historical-2020", "marketCode": "US", "labelVersion": { "zh": "FDA 美国历史口服片标签（2020-05；非现行包装或供应结论）", "en": "FDA U.S. historical oral-tablet label (May 2020; not a current-package or availability finding)" }, "dosageForm": { "zh": "莫西沙星椭圆形暗红色薄膜衣口服片", "en": "moxifloxacin oblong dull-red film-coated oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 50419-530-01", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片 400 mg；30 片瓶装（美国历史标签）", "en": "400 mg per tablet; 30-tablet bottle (U.S. historical label)" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "莫西沙星", "en": "moxifloxacin" }, "value": 400, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片历史标签标示量；不是个人片数或剂量", "en": "historical labelled amount per tablet; not an individual tablet count or dose" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": null, "package": { "count": 30, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "暗红色", "en": "dull red" }, "shape": { "zh": "椭圆形薄膜衣片", "en": "oblong film-coated tablet" }, "imprint": "BAYER / M400", "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_487d9f44373cfb28", "label": "FDA：AVELOX 莫西沙星 400 mg 口服片、30 片瓶装（NDC 50419-530-01；2020 美国历史标签）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021085s066%2C021277s062lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "status": "withheld_repackaged_or_non_exact_visual", "title": { "zh": "已核验到再包装历史标签，故不展示为原品牌包装", "en": "A repackaged historical label was located, so it is not shown as an original-brand package" }, "summary": { "zh": "DailyMed 的 AVELOX ABC PACK 历史标签列示 RedPharm Drug Inc. 为包装方。即使标签中含有 AVELOX 与 Bayer 文字，也不能把该再包装历史标签当作本页原品牌包装图；因此本页不展示该图。", "en": "The DailyMed AVELOX ABC PACK historical label lists RedPharm Drug Inc. as the packager. Even where the label includes AVELOX and Bayer wording, that repackaged historical label cannot be presented as this record's original-brand package image; it is therefore not shown here." }, "source": { "id": "src_ef07988484e1ce20", "label": "DailyMed（NLM）：AVELOX ABC PACK 再包装历史标签", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=fe9226f8-64f4-4eff-8339-ed3fce0896f2", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "AVELOX 说明书放大阅读：400 mg 口服片与静脉制剂不能按同一数字互推", "en": "AVELOX label reading: a 400 mg oral tablet and an intravenous product cannot be inferred from the same number" }, "summary": { "zh": "本模块以 FDA 2020 美国 AVELOX 公开标签为阅读入口。该文件同时包含口服片与静脉制剂；本页仅帮助核对 400 mg 口服片的品牌、通用名、剂型、给药途径和警告位置，不判断个人是否需要抗菌药，也不生成片数、疗程、换药或联用方案。", "en": "This module uses the 2020 U.S. FDA AVELOX public label as a reading entry point. The file includes both oral tablets and intravenous products; this page only helps identify the 400 mg oral tablet’s brand, generic, dosage form, route and warning locations. It does not decide whether an individual needs an antibacterial medicine or create a tablet count, course, switching or combination plan." }, "checks": [ { "zh": "先同时核对 AVELOX、莫西沙星、400 mg、口服片和目标市场。400 mg 是该口服片的身份字段，不是任何人“今天该用几片、用多久”或能否把剩药继续使用的答案。", "en": "First check AVELOX, moxifloxacin, 400 mg, oral tablet and target market together. 400 mg is an identity field for that oral tablet, not an answer to how many tablets anyone should use today, for how long, or whether leftovers can be continued." }, { "zh": "同一 FDA 文件也列有静脉制剂；口服片与静脉输注产品的剂型、路径和管理要求不同，不能把静脉袋文字、口服片数字或另一种莫西沙星/氟喹诺酮产品互相换算。", "en": "The same FDA file also lists an intravenous product. Oral tablets and intravenous infusions differ in dosage form, route and handling requirements; intravenous-bag wording, oral-tablet numbers and another moxifloxacin or fluoroquinolone product must not be converted across one another." }, { "zh": "FDA 标签含氟喹诺酮类严重不良反应、心律风险和相互作用相关警告。若出现肌腱疼痛或肿胀、麻木刺痛、明显神经或精神状态改变、心悸或晕厥、呼吸困难、皮疹或面部/口腔肿胀等急性或严重不适，应及时使用当地医疗支持，而不是依据网页自行换另一种抗菌药或继续使用。", "en": "The FDA label includes warnings about serious fluoroquinolone reactions, heart-rhythm risk and interactions. With acute or serious symptoms such as tendon pain or swelling, numbness or tingling, marked neurologic or mental-status change, palpitations or fainting, breathing difficulty, rash, or swelling of the face or mouth, use timely local medical support rather than switching to another antibacterial medicine or continuing based on a webpage." }, { "zh": "抗菌药是否需要、选择哪一种、给药途径和疗程必须由具体感染、检查资料、个人状况、完整药单和目标市场现行标签共同决定。尤其同时使用影响心律、血糖、抗凝、含矿物质补充剂或多种处方/非处方产品时，应带实际药盒请医生或药师复核。", "en": "Whether an antibacterial medicine is needed, which one is selected, route and course must be determined from the specific infection, testing, individual circumstances, complete medicine list and current target-market label. Especially with products that affect heart rhythm, glucose or anticoagulation, mineral-containing supplements, or multiple prescription/OTC products, bring the actual pack to a clinician or pharmacist for review." } ], "source": { "id": "src_487d9f44373cfb28", "label": "FDA：AVELOX 2020 美国处方信息（NDA 021085 / 021277）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021085s066%2C021277s062lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "莫西沙星怎样起作用：它干扰细菌 DNA 复制所需的两种酶", "en": "How moxifloxacin works: it interferes with two enzymes needed for bacterial DNA replication" }, "summary": { "zh": "FDA 2020 公开标签描述莫西沙星抑制细菌 DNA 旋转酶（拓扑异构酶 II）和拓扑异构酶 IV；这些酶与细菌 DNA 的复制、转录、修复和重组有关。该机制只帮助理解药物类别，不能判断某种症状是否为细菌感染，也不能选择抗菌药、途径或疗程。", "en": "The 2020 FDA public label describes moxifloxacin as inhibiting bacterial DNA gyrase (topoisomerase II) and topoisomerase IV, enzymes involved in bacterial DNA replication, transcription, repair and recombination. This mechanism only helps explain a drug class; it cannot determine whether symptoms are bacterial or select an antibacterial medicine, route or course." }, "checks": [ { "zh": "“干扰细菌 DNA”不是感染诊断、培养结果或选药结论。是否需要抗菌药，仍须由具体感染、检查资料、个人状况和目标市场现行标签共同判断。", "en": "“Interferes with bacterial DNA” is not an infection diagnosis, culture result or medicine-selection conclusion. Whether an antibacterial medicine is needed still depends on the specific infection, testing, individual circumstances and current target-market label." }, { "zh": "同属氟喹诺酮类或共享作用路径，不使 AVELOX 与左氧氟沙星、环丙沙星或其他抗菌药可自行叠加、轮换、替换或按 mg 换算。产品身份、给药途径、强度、相互作用和现行处方必须分别核对。", "en": "Being in the fluoroquinolone class or sharing a pathway does not make AVELOX self-combinable, switchable, substitutable or milligram-convertible with levofloxacin, ciprofloxacin or another antibacterial medicine. Product identity, route, strength, interactions and current prescription must each be checked separately." }, { "zh": "机制页面也不能决定联用、换药、停用或疗程长短。正在使用多种药物、出现不适或考虑改变方案时，应带上实际包装和完整药单请医生或药师复核。", "en": "A mechanism page also cannot decide combination, switching, stopping or course length. With multiple medicines, symptoms or a contemplated change, take the actual pack and complete medicine list to a clinician or pharmacist for review." } ], "source": { "id": "src_487d9f44373cfb28", "label": "FDA：AVELOX 2020 美国处方信息（临床药理与微生物学）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021085s066%2C021277s062lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "Avelox", "generic": "莫西沙星", "dosageFormClass": "口服片剂：400 mg 莫西沙星（FDA 2020 标签所列；本页仅覆盖口服片）" }, "labelSource": { "id": "src_487d9f44373cfb28", "label": "FDA：AVELOX 2020 美国处方信息（NDA 021085 / 021277）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021085s066%2C021277s062lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "productRoutes": [ { "source": { "id": "src_487d9f44373cfb28", "label": "FDA：AVELOX 2020 美国处方信息（NDA 021085 / 021277）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021085s066%2C021277s062lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [ { "id": "fda-2013-systemic-fluoroquinolone-peripheral-neuropathy-label-change", "issuedAt": "2013-08-15", "status": "fda_class_safety_communication", "title": { "zh": "FDA 药物安全通讯：全身用氟喹诺酮类的周围神经病变标签更新", "en": "FDA Drug Safety Communication: peripheral-neuropathy label updates for systemic fluoroquinolones" }, "summary": { "zh": "FDA 于 2013-08-15 发布药物安全通讯，要求全身用（口服或注射）氟喹诺酮类的说明书和患者用药指南更清楚说明周围神经病变风险；公告明确列出 Levaquin、Cipro 和 Avelox，并说明该风险可在开始用药后不久出现且可能持续。本记录是特定日期的美国类别监管通讯，不把同类关系变成任何个人的停药、改药、剂型转换或症状归因结论；出现疼痛、灼热、麻刺、麻木、无力或感觉异常等急性或令人担忧的不适，应使用当地医疗支持并由专业人员核对实际产品与完整药单。", "en": "On 2013-08-15, FDA issued a Drug Safety Communication requiring clearer peripheral-neuropathy information in labels and Medication Guides for systemic (oral or injectable) fluoroquinolones. The notice explicitly lists Levaquin, Cipro and Avelox, and says this risk may occur soon after treatment starts and may persist. This is a dated U.S. class communication; it does not turn class membership into an individual stop, switch, dosage-form conversion or symptom-attribution conclusion. With acute or concerning pain, burning, tingling, numbness, weakness or altered sensation, use local medical support and have a professional check the actual product and complete medicine list." }, "source": { "id": "src_15292a025a5f8cfe", "label": "FDA：2013-08-15 全身用氟喹诺酮类周围神经病变标签更新药物安全通讯", "url": "https://www.fda.gov/media/86575/download", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "FDA 的 AVELOX（moxifloxacin）2020 美国公开标签同时列有口服片和静脉制剂，并列示美国初始批准年份为 1999。本页建立一张 400 mg、NDC 50419-530-01、30 片瓶装的历史文字身份卡，用于核对品牌、通用名、口服剂型和历史市场文件；不把同一文件中的静脉制剂文字推成个人用法、片数、疗程、换药或购买结论。", "history": "“400 mg”、NDC 50419-530-01 与 30 片瓶装共同帮助确认该 FDA 历史文件所列的一款口服片身份，并不回答个人每天应使用多少、使用多久或能否继续使用。口服片、静脉制剂、其他氟喹诺酮类、其他市场标签和剩余抗菌药都不能仅凭名称或数字自行互换、拼量、轮换或继续使用。FDA 页面也说明该历史标签未必是最新获批标签，目标市场的现行官方文件须单独核对。", "sourceDocuments": [ { "id": "src_487d9f44373cfb28", "label": "FDA：AVELOX 2020 美国处方信息（NDA 021085 / 021277）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021085s066%2C021277s062lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_5ed30b676fbb9773", "label": "FDA Drugs@FDA 官方检索入口", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_lookup_entry", "documentKind": "regulatory_lookup", "market": "US", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } ], "applicationNumber": "NDA 021085 / 021277", "approvalTimeline": [ { "date": "1999", "title": { "zh": "FDA 标签所列美国初始批准年份", "en": "Initial U.S. approval year listed in the FDA label" }, "detail": { "zh": "本页链接的 FDA 标签档案列示 Initial U.S. Approval: 1999。该历史定位不等同于当前批准、可得性、持有人或其他市场状态。", "en": "The FDA label archive linked here lists Initial U.S. Approval: 1999. This historical locator is not a conclusion about current approval, availability, holder or another market." }, "source": { "id": "src_487d9f44373cfb28", "label": "FDA: AVELOX tablet and injection label archive", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021085s066%2C021277s062lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, { "date": "2020-05", "title": { "zh": "FDA 标签档案版本", "en": "FDA label archive version" }, "detail": { "zh": "本页链接 2020-05 的 FDA 标签档案作为可复核阅读入口。现行标签、规格、适应症和安全信息必须另行以目标市场当前文件核对。", "en": "This page links the 2020-05 FDA label archive as a traceable reading entry point. Current labeling, strength, indication and safety information require separate verification against the target market’s current document." }, "source": { "id": "src_487d9f44373cfb28", "label": "FDA: AVELOX tablet and injection label archive", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021085s066%2C021277s062lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "已链接公开标签档案", "en": "Public label archive linked" }, "detail": { "zh": "仅对应本页所列 FDA 文件。", "en": "Only the FDA document listed on this page is linked." } }, { "market": { "zh": "中国大陆、欧盟、日本", "en": "Mainland China, EU, Japan" }, "status": { "zh": "待逐项建立市场记录", "en": "Market record not established" }, "detail": { "zh": "不从美国标签档案推定当地批准、持有人、规格、供应或可售资格。", "en": "No local approval, holder, strength, supply or sale-eligibility conclusion is inferred from the U.S. label archive." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "标签档案能代表现在的产品信息吗？", "en": "Does a label archive represent current product information?" }, "answer": { "zh": "不能自动代表。档案用于定位来源；需要以目标市场的现行官方标签逐项复核。", "en": "Not automatically. The archive locates a source; each point needs verification against the target market’s current official label." } }, { "question": { "zh": "为什么这里不展示价格或原研/仿制结论？", "en": "Why are price and originator/generic conclusions not shown?" }, "answer": { "zh": "这些结论需要产品、剂型、规格、包装、市场、日期和原始记录分别齐全并经人工审核；单一标签文件不足以支持。", "en": "Those conclusions require separately complete and human-reviewed product, dosage-form, strength, pack, market, date and primary-record fields; one label file is insufficient." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "how-to-read-a-drug-label", "regulatory-sources-first" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/avelox/", "en": "https://origindrug.com/en/drugs/avelox/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "macrobid", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-21", "status": "published_traceable_archive" }, "names": { "brand": "MACROBID", "generic": "呋喃妥因单水合物/大结晶", "aliases": [ "MACROBID", "nitrofurantoin monohydrate/macrocrystals", "呋喃妥因单水合物/大结晶", "呋喃妥因单水合物大结晶", "nitrofurantoin monohydrate macrocrystals" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "感染", "sourceArchiveMarket": "美国 MACROBID 当前公开标签（DailyMed SPL v26，2025-11-17 发布；页面 2025-10-14 更新）", "dosageFormClass": "硬明胶口服胶囊：每粒总呋喃妥因 100 mg，由 25 mg 大结晶和 75 mg 单水合物组成；仅本档案所引美国标签面板", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "当前标签未在本页建立美国初始批准年份结论", "archiveSponsorText": "Almatica Pharma LLC / DailyMed（NLM）当前公开标签" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [ "MACRODANTIN", "nitrofurantoin macrocrystals 50 mg", "呋喃妥因大结晶 50 mg" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-macrobid-nitrofurantoin-100mg-100-capsule-bottle-ndc-52427-285-01", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v26，2025-11-17 发布；页面 2025-10-14 更新", "en": "DailyMed SPL v26, published 17 Nov 2025; page updated 14 Oct 2025" }, "dosageForm": { "zh": "MACROBID 呋喃妥因单水合物/大结晶硬明胶口服胶囊", "en": "MACROBID nitrofurantoin monohydrate/macrocrystals hard gelatin oral capsule" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 52427-285-01", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_capsule", "primaryDisplay": { "zh": "每粒总呋喃妥因 100 mg：大结晶 25 mg + 单水合物 75 mg；100 粒瓶装", "en": "100 mg total nitrofurantoin per capsule: 25 mg macrocrystals + 75 mg monohydrate; 100-capsule bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=8f270a9f-12a1-44d4-bc7e-873613555801&name=macrobid-label.jpg", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "呋喃妥因大结晶", "en": "nitrofurantoin macrocrystals" }, "value": 25, "unit": "mg", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒标签中的大结晶部分；不是个人胶囊数或换算", "en": "macrocrystal portion per labelled capsule; not an individual capsule count or conversion" } }, { "ingredient": { "zh": "呋喃妥因单水合物", "en": "nitrofurantoin monohydrate" }, "value": 75, "unit": "mg", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒标签中的单水合物部分；不是个人胶囊数或换算", "en": "monohydrate portion per labelled capsule; not an individual capsule count or conversion" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "100 粒瓶装", "en": "100-capsule bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-21", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "physicalClues": { "color": { "zh": "黑黄双色", "en": "opaque black and yellow" }, "shape": { "zh": "硬明胶胶囊", "en": "hard gelatin capsule" }, "imprint": "Macrobid / 52427-285", "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_fbaf71cc396fb018", "label": "DailyMed（NLM）：MACROBID 呋喃妥因单水合物/大结晶当前美国公开标签（Almatica Pharma；SPL v26）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8f270a9f-12a1-44d4-bc7e-873613555801", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-macrobid-nitrofurantoin-100mg-100-capsule-bottle-ndc-52427-285-01", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=8f270a9f-12a1-44d4-bc7e-873613555801&name=macrobid-label.jpg", "alt": "MACROBID 呋喃妥因单水合物/大结晶在美国 DailyMed 当前标签中的每粒总呋喃妥因 100 mg、NDC 52427-285-01、100 粒瓶装展示面", "archiveMarket": "美国", "labelVersion": "DailyMed SPL v26，2025-11-17 发布；页面 2025-10-14 更新", "presentation": "MACROBID：每粒总呋喃妥因 100 mg（大结晶 25 mg + 单水合物 75 mg），NDC 52427-285-01，100 粒瓶装展示面。", "notice": "此图只对应美国 DailyMed 当前标签中的 MACROBID、两种呋喃妥因形式、每粒总 100 mg、NDC 52427-285-01 与 100 粒瓶装。它只帮助核对品牌、通用名、制剂组成、每粒标签量、口服胶囊、外形线索、包装数量与来源；不用于鉴定真伪，也不证明 MACRODANTIN、其他呋喃妥因制剂、其他包装、其他市场、当前可得性、原研身份、可替代性或任何个人的胶囊数、疗程、换药或处理方案。", "source": { "id": "src_fbaf71cc396fb018", "label": "DailyMed（NLM）：MACROBID 呋喃妥因单水合物/大结晶当前美国公开标签（Almatica Pharma；SPL v26）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8f270a9f-12a1-44d4-bc7e-873613555801", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "MACROBID 说明书放大阅读：100 mg 是每粒总量，25 mg + 75 mg 是同一粒胶囊的两种形式", "en": "MACROBID label reading: 100 mg is the total per capsule; 25 mg + 75 mg are two forms in that same capsule" }, "summary": { "zh": "本模块只阅读美国 DailyMed 当前公开标签中的 MACROBID、两种呋喃妥因形式、每粒总量、准确 NDC、100 粒瓶装和口服胶囊。它不提供个人胶囊数、疗程、漏用处理、开始、停用、联用、换药或购买方案。", "en": "This module reads only MACROBID, its two nitrofurantoin forms, total per capsule, exact NDC, 100-capsule bottle and oral-capsule form in the current U.S. DailyMed public label. It provides no individual capsule count, course, missed-use handling, start, stop, co-use, switch or purchase plan." }, "checks": [ { "zh": "先把 MACROBID、呋喃妥因单水合物/大结晶、每粒总 100 mg、NDC 52427-285-01、100 粒瓶装、硬明胶口服胶囊和目标市场一起核对。只看到“呋喃妥因”或“100 mg”，不能证明另一种制剂、包装或国家/地区产品相同。", "en": "Check MACROBID, nitrofurantoin monohydrate/macrocrystals, 100 mg total per capsule, NDC 52427-285-01, 100-capsule bottle, hard-gelatin oral capsule and target market together. Seeing only “nitrofurantoin” or “100 mg” does not prove another formulation, package or market product is the same." }, { "zh": "标签中的 25 mg 大结晶 + 75 mg 单水合物，是这一粒 MACROBID 胶囊的两部分组成；不是两粒、两次服用，也不是把另一种 25 mg、50 mg 或 100 mg 呋喃妥因胶囊按心算拼出来的规则。", "en": "The label's 25 mg macrocrystals + 75 mg monohydrate are two parts of one MACROBID capsule; they are not two capsules, two uses, or a rule for mentally assembling another 25 mg, 50 mg or 100 mg nitrofurantoin capsule." }, { "zh": "MACRODANTIN 与仅标示“nitrofurantoin macrocrystals”的产品不是本页这份双形式 MACROBID 胶囊。相同活性成分、相近毫克数或都写“尿路抗菌药”都不足以决定能否自行替换、交替或叠加。", "en": "MACRODANTIN and products labelled only “nitrofurantoin macrocrystals” are not this two-form MACROBID capsule. A shared active ingredient, a similar milligram number or “urinary antibacterial” wording is not enough to decide self-substitution, alternation or combination." }, { "zh": "抗菌药标签的适用范围、治疗时间、与食物同服、肾功能、既往反应和全部药单都需按准确处方及目标市场现行标签处理。发热、腰背痛、恶心呕吐、皮疹、呼吸不适、黄疸样变化或其他急性问题，应使用当地医疗与开方团队渠道；不要仅凭网页自行开始、延长、重复、停用或换药。", "en": "An antibacterial label's scope, duration, food instructions, kidney function, prior reactions and complete medicine list must be handled through the exact prescription and current target-market label. With fever, flank or back pain, nausea/vomiting, rash, breathing trouble, jaundice-like changes or another acute concern, use local medical and prescribing-team pathways; do not self-start, extend, repeat, stop or switch from a webpage." } ], "source": { "id": "src_fbaf71cc396fb018", "label": "DailyMed（NLM）：MACROBID 呋喃妥因单水合物/大结晶当前美国公开标签（Almatica Pharma；SPL v26）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8f270a9f-12a1-44d4-bc7e-873613555801", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "MACROBID 的两种形式怎样影响释放阅读：较慢溶出的部分与凝胶基质释放，不等于可自行换算", "en": "How MACROBID's two forms inform release reading: slower dissolution and gel-matrix release do not permit self-conversion" }, "summary": { "zh": "当前美国标签描述：每粒 MACROBID 含两种呋喃妥因形式；大结晶部分较单水合物溶出和吸收更慢，单水合物粉末混合物在胃肠液中形成凝胶基质并随时间释放呋喃妥因。这解释制剂阅读，不预测个人疗效、尿液颜色变化、胶囊数、疗程或换药方案。", "en": "The current U.S. label describes two nitrofurantoin forms in each MACROBID capsule: the macrocrystal portion dissolves and absorbs more slowly than monohydrate, while the monohydrate powder blend forms a gel matrix in gastric and intestinal fluids that releases nitrofurantoin over time. This explains formulation reading, not individual effect, urine-colour change, capsule count, course or a switch plan." }, "checks": [ { "zh": "“较慢溶出”“凝胶基质”“随时间释放”描述的是标签所列这一准确制剂的物理药学路径；它不等于“更强”“更安全”或“可以把胶囊拆开、对半、与另一制剂换算”。", "en": "“Slower dissolution,” “gel matrix” and “releases over time” describe the pharmaceutic pathway of this exact labelled formulation; they do not mean “stronger,” “safer,” or that a capsule may be opened, halved or converted to another formulation." }, { "zh": "同为呋喃妥因、同写 100 mg 或都用于相近的泌尿问题，不表示双形式胶囊、单一大结晶胶囊、其他品牌或其他市场产品可以自行轮换、叠加或互相代替。", "en": "Sharing nitrofurantoin, a 100 mg marking or a similar urinary indication does not make a two-form capsule, a macrocrystal-only capsule, another brand or another-market product suitable for self-alternation, combination or substitution." }, { "zh": "机制和包装也不能说明某次尿路症状是否需要抗菌药、哪种产品适合、是否可继续或何时改药。出现症状加重、发热、腰背痛、严重过敏样反应、呼吸不适或其他急性问题时，应及时使用当地医疗支持。", "en": "Mechanism and packaging also cannot determine whether a urinary symptom needs an antibacterial, which product fits, whether use continues or when it changes. With worsening symptoms, fever, flank/back pain, a severe allergy-like reaction, breathing trouble or another acute concern, use timely local medical support." } ], "source": { "id": "src_fbaf71cc396fb018", "label": "DailyMed（NLM）：MACROBID 呋喃妥因单水合物/大结晶当前美国公开标签（Clinical Pharmacology）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8f270a9f-12a1-44d4-bc7e-873613555801", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "MACROBID", "generic": "呋喃妥因单水合物/大结晶", "dosageFormClass": "硬明胶口服胶囊：每粒总呋喃妥因 100 mg，由 25 mg 大结晶和 75 mg 单水合物组成；仅本档案所引美国标签面板" }, "labelSource": { "id": "src_fbaf71cc396fb018", "label": "DailyMed（NLM）：MACROBID 呋喃妥因单水合物/大结晶当前美国公开标签（Almatica Pharma；SPL v26）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8f270a9f-12a1-44d4-bc7e-873613555801", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "productRoutes": [ { "source": { "id": "src_fbaf71cc396fb018", "label": "DailyMed（NLM）：MACROBID 呋喃妥因单水合物/大结晶当前美国公开标签（Almatica Pharma；SPL v26）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8f270a9f-12a1-44d4-bc7e-873613555801", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "美国 DailyMed 当前公开标签将 MACROBID 列为呋喃妥因单水合物/大结晶硬明胶口服胶囊；每粒总呋喃妥因 100 mg，包括 25 mg 大结晶和 75 mg 单水合物。它帮助核对商品名、两种形式、每粒标示量、准确 NDC、100 粒瓶装和美国标签来源；不把“100 mg”、两种形式或说明书文字变成个人胶囊数、疗程、开始、停用、联用、换药或购买建议。", "history": "当前标签说明大结晶部分的溶出和吸收较单水合物更慢，单水合物粉末混合物在胃肠液中形成凝胶基质并随时间释放呋喃妥因。该制剂机制不表示 MACROBID 可与 MACRODANTIN、其他呋喃妥因制剂、不同市场产品或其他抗菌药自行换算、轮换或替代。", "sourceDocuments": [ { "id": "src_fbaf71cc396fb018", "label": "DailyMed（NLM）：MACROBID 呋喃妥因单水合物/大结晶当前美国公开标签（Almatica Pharma；SPL v26）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8f270a9f-12a1-44d4-bc7e-873613555801", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } ], "applicationNumber": "DailyMed SPL setid 8f270a9f-12a1-44d4-bc7e-873613555801 (v26)", "approvalTimeline": [ { "date": "2025-10-14", "title": { "zh": "当前 DailyMed 页面更新", "en": "Current DailyMed page updated" }, "detail": { "zh": "当前 MACROBID 页面列示更新日期为 2025-10-14。该日期只定位本页所链接的美国公开标签，不建立其他市场批准、供应、购买资格、原研/仿制关系或个人用药结论。", "en": "The current MACROBID page lists an update date of 14 Oct 2025. This date only locates the linked U.S. public label; it does not establish approval, supply, purchase eligibility, originator/generic relationship or individual-use conclusions in another market." }, "source": { "id": "src_fbaf71cc396fb018", "label": "DailyMed（NLM）：MACROBID 呋喃妥因单水合物/大结晶当前美国公开标签（Almatica Pharma；SPL v26）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8f270a9f-12a1-44d4-bc7e-873613555801", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, { "date": "2025-11-17", "title": { "zh": "当前 DailyMed SPL v26 公开", "en": "Current DailyMed SPL v26 published" }, "detail": { "zh": "当前标签记录列示 SPL v26 于 2025-11-17 发布。页面仅展示 NDC 52427-285-01 的 100 粒瓶装展示面，帮助核对两种呋喃妥因形式与包装身份；不建立实际在售、库存、购买、个人胶囊数、疗程、换药或可替代性。", "en": "The current label record lists SPL v26 as published on 17 Nov 2025. The page shows only the NDC 52427-285-01 100-capsule bottle panel to check the two nitrofurantoin forms and package identity; it does not establish actual availability, stock, purchase, individual capsule count, course, switching or interchangeability." }, "source": { "id": "src_fbaf71cc396fb018", "label": "DailyMed（NLM）：MACROBID 呋喃妥因单水合物/大结晶当前美国公开标签（Almatica Pharma；SPL v26）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8f270a9f-12a1-44d4-bc7e-873613555801", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "已链接当前公开标签与一个准确 100 粒瓶装展示面", "en": "Current public label and one exact 100-capsule bottle panel linked" }, "detail": { "zh": "本页面板对应 NDC 52427-285-01，且只描述双形式 MACROBID 胶囊的标签身份。它不用于鉴定真伪，也不建立实际在售、库存、购买、个人胶囊数、疗程、开始、停用、联用、换药或可替代性。", "en": "This panel corresponds to NDC 52427-285-01 and describes only the label identity of the two-form MACROBID capsule. It does not authenticate a product or establish actual availability, stock, purchase, individual capsule count, course, initiation, stopping, co-use, switching or interchangeability." } }, { "market": { "zh": "中国大陆、欧盟、日本及其他市场", "en": "Mainland China, EU, Japan and other markets" }, "status": { "zh": "待逐项建立现行市场记录", "en": "Current market record not established" }, "detail": { "zh": "不从美国标签、NDC 或品牌名称推定当地商品名、批准、包装、供应、可售资格、原研/仿制关系或可替代性；每个市场均需按当地现行监管资料单独核对。", "en": "No local trade name, approval, packaging, supply, sale eligibility, originator/generic relationship or interchangeability is inferred from the U.S. label, NDC or brand name; every market needs separate checking against current local regulatory material." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "MACROBID 100 mg 与 MACRODANTIN 50 mg 或 100 mg 都是呋喃妥因，能否自行按毫克数换着用？", "en": "MACROBID 100 mg and MACRODANTIN 50 mg or 100 mg all name nitrofurantoin. Can they be self-converted by milligrams?" }, "answer": { "zh": "不能。当前 MACROBID 标签说明它是一粒中含 25 mg 大结晶与 75 mg 单水合物的双形式胶囊，并提到其尿中排泄数据与某些 MACRODANTIN 胶囊存在可比性；这不是个人换算、换药、轮换、叠加或决定疗程的规则。两者的准确制剂、处方目的、肾功能、既往反应和完整药单都需要由药师或开方团队核对。", "en": "No. The current MACROBID label describes a two-form capsule containing 25 mg macrocrystals and 75 mg monohydrate, and notes comparable urinary-excretion data with certain MACRODANTIN capsules. That is not a rule for self-conversion, switching, alternating, combining or deciding a course. The exact formulations, prescribing purpose, kidney function, prior reactions and complete medicine list require pharmacist or prescriber review." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/macrobid/", "en": "https://origindrug.com/en/drugs/macrobid/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "diflucan", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-24", "status": "published_traceable_archive" }, "names": { "brand": "Diflucan", "generic": "氟康唑", "aliases": [ "fluconazole" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "感染", "sourceArchiveMarket": "美国 DailyMed 有日期公开标签（2026-04 更新；本页分别展示三个准确 30 片瓶装面板）", "dosageFormClass": "口服片剂：50 mg、100 mg、150 mg、200 mg；口服混悬液：复溶后 10 mg/mL、40 mg/mL；另有静脉输注用制剂（DailyMed 2026-04 公开标签所列）", "dosageFormClassCode": "multiple_forms_and_routes", "route": "口服 / 静脉输注", "routeCode": "multiple", "historicalApprovalEntry": "美国初始批准年份待逐项核验", "archiveSponsorText": "Pfizer / DailyMed 公开监管标签档案" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-diflucan-fluconazole-tablet-50mg-30-bottle-ndc-0049-3410-30", "marketCode": "US", "labelVersion": { "zh": "DailyMed 美国有日期公开标签（Pfizer，2026-04 更新）", "en": "DailyMed U.S. dated public label (Pfizer, updated Apr 2026)" }, "dosageForm": { "zh": "DIFLUCAN 氟康唑口服片", "en": "DIFLUCAN fluconazole oral tablet" }, "route": { "zh": "口服（标签产品身份字段）", "en": "oral (label product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 0049-3410-30", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片 50 mg；30 片瓶装", "en": "50 mg per tablet; 30-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=diflucan-03.jpg&setid=f694c617-3383-416c-91b6-b94fda371204&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "氟康唑", "en": "fluconazole" }, "value": 50, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、剂量、分片、换算或换药指令", "en": "labelled amount per tablet; not an individual's tablet count, dose, splitting, conversion or switching instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "30 片瓶装", "en": "30-tablet bottle" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-24", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 30, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_6fabc885747065d9", "label": "DailyMed（NLM）：DIFLUCAN 氟康唑美国公开标签（Pfizer，2026-04 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=f694c617-3383-416c-91b6-b94fda371204", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-24", "reviewedAt": "2026-08-24" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-diflucan-fluconazole-tablet-100mg-30-bottle-ndc-0049-3420-30", "marketCode": "US", "labelVersion": { "zh": "DailyMed 美国有日期公开标签（Pfizer，2026-04 更新）", "en": "DailyMed U.S. dated public label (Pfizer, updated Apr 2026)" }, "dosageForm": { "zh": "DIFLUCAN 氟康唑口服片", "en": "DIFLUCAN fluconazole oral tablet" }, "route": { "zh": "口服（标签产品身份字段）", "en": "oral (label product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 0049-3420-30", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片 100 mg；30 片瓶装", "en": "100 mg per tablet; 30-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=diflucan-04.jpg&setid=f694c617-3383-416c-91b6-b94fda371204&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "氟康唑", "en": "fluconazole" }, "value": 100, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、剂量、分片、换算或换药指令", "en": "labelled amount per tablet; not an individual's tablet count, dose, splitting, conversion or switching instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "30 片瓶装", "en": "30-tablet bottle" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-24", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 30, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_6fabc885747065d9", "label": "DailyMed（NLM）：DIFLUCAN 氟康唑美国公开标签（Pfizer，2026-04 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=f694c617-3383-416c-91b6-b94fda371204", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-24", "reviewedAt": "2026-08-24" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-diflucan-fluconazole-tablet-200mg-30-bottle-ndc-0049-3430-30", "marketCode": "US", "labelVersion": { "zh": "DailyMed 美国有日期公开标签（Pfizer，2026-04 更新）", "en": "DailyMed U.S. dated public label (Pfizer, updated Apr 2026)" }, "dosageForm": { "zh": "DIFLUCAN 氟康唑口服片", "en": "DIFLUCAN fluconazole oral tablet" }, "route": { "zh": "口服（标签产品身份字段）", "en": "oral (label product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 0049-3430-30", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片 200 mg；30 片瓶装", "en": "200 mg per tablet; 30-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=diflucan-09.jpg&setid=f694c617-3383-416c-91b6-b94fda371204&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "氟康唑", "en": "fluconazole" }, "value": 200, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、剂量、分片、换算或换药指令", "en": "labelled amount per tablet; not an individual's tablet count, dose, splitting, conversion or switching instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "30 片瓶装", "en": "30-tablet bottle" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-24", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 30, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_6fabc885747065d9", "label": "DailyMed（NLM）：DIFLUCAN 氟康唑美国公开标签（Pfizer，2026-04 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=f694c617-3383-416c-91b6-b94fda371204", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-24", "reviewedAt": "2026-08-24" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-diflucan-fluconazole-tablet-50mg-30-bottle-ndc-0049-3410-30", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=diflucan-03.jpg&setid=f694c617-3383-416c-91b6-b94fda371204&type=img", "alt": "DIFLUCAN 50 mg 氟康唑片在美国 DailyMed 公开标签中的 Pfizer 30 片瓶装标签图", "archiveMarket": "美国", "labelVersion": "DailyMed 公开标签（2026-04 更新）", "presentation": "DIFLUCAN 50 mg、30 片瓶装标签图（DailyMed 公开标签所列；Pfizer 标签图）。", "notice": "此为美国 DailyMed 公开标签中明确对应 DIFLUCAN 50 mg、30 片瓶装的 Pfizer 标签图，只帮助核对品牌、通用名、标示强度、片剂和来源；不用于鉴定真伪，也不证明 100 mg/150 mg/200 mg、口服混悬液、静脉用制剂、其他包装、其他市场标签、当前包装、原研身份、目标市场批准或可售资格。", "source": { "id": "src_6fabc885747065d9", "label": "DailyMed（NLM）：DIFLUCAN 氟康唑美国公开标签（Pfizer，2026-04 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=f694c617-3383-416c-91b6-b94fda371204", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-24", "reviewedAt": "2026-08-24" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "DIFLUCAN 说明书放大阅读：片剂、口服混悬液与静脉输注不能只按“氟康唑”互换", "en": "DIFLUCAN label reading: tablets, oral suspension and intravenous infusion are not interchangeable just because all say fluconazole" }, "summary": { "zh": "本模块以 DailyMed 2026 公开标签为阅读入口，帮助核对 DIFLUCAN、氟康唑、片剂或口服混悬液、标示强度/浓度和目标市场；它不判断是否需要抗真菌药，也不把包装数字换成个人片数、毫升数、输注量或疗程。", "en": "This module uses the 2026 DailyMed public label as a reading entry point. It helps check DIFLUCAN, fluconazole, tablet or oral suspension, labelled strength/concentration and target market; it does not decide whether an antifungal is needed or turn package numbers into an individual's tablet count, millilitre amount, infusion amount or course." }, "checks": [ { "zh": "先把 DIFLUCAN、氟康唑、准确剂型和目标市场放在一起核对。50、100、150、200 mg 是不同片剂的标示强度；10 或 40 mg/mL 是复溶后口服混悬液的浓度。它们不是同一种单位，不能据此自行把“几片”换成“几毫升”。", "en": "Check DIFLUCAN, fluconazole, the exact dosage form and target market together. 50, 100, 150 and 200 mg identify tablet strengths; 10 or 40 mg/mL identifies the concentration of reconstituted oral suspension. They are not the same unit and do not support self-conversion from “tablets” to “millilitres.”" }, { "zh": "标签将片剂、口服混悬液和静脉用产品分别列示；同一通用名、相近总毫克数或“都与真菌有关”的说法，都不能证明可以自行替换、合并、分装、借给家人或从口服改为输注。", "en": "The label lists tablets, oral suspension and intravenous products separately. A shared generic name, a nearby total milligram number, or the idea that they are all fungus-related does not prove that products can be self-substituted, combined, divided, shared with family or changed from oral use to infusion." }, { "zh": "氟康唑相关标签包含多种联用与特定人群注意事项。正在使用抗凝药、降糖药、抗癫痫药、免疫抑制剂、其他抗感染药或多种慢病药时，应把完整药单、实际包装和最近变化交给药师或开方团队复核，不要凭网页判断能否同用或如何调整。", "en": "Fluconazole-related labels include multiple co-medication and population precautions. With an anticoagulant, glucose-lowering medicine, antiseizure medicine, immunosuppressant, another anti-infective or several chronic-care medicines, have a pharmacist or prescribing team review the complete list, actual packages and recent changes; do not use a webpage to decide combination or adjustment." }, { "zh": "“抗真菌”不等于任何皮疹、瘙痒、口腔不适或分泌物变化都可自行开始或重复使用。症状原因、检测、孕期可能性、肝肾情况、其他用药和现行标签都可能影响专业判断；严重不适或不确定怎样使用时，应及时走当地医疗支持渠道。", "en": "“Antifungal” does not mean that every rash, itch, oral discomfort or discharge change can be self-started or repeated. Symptom cause, testing, possible pregnancy, liver/kidney context, other medicines and the current label can all affect professional assessment; with severe illness or uncertainty about use, use timely local medical support." } ], "source": { "id": "src_6fabc885747065d9", "label": "DailyMed（NLM）：DIFLUCAN 氟康唑美国公开标签（Pfizer，2026-04 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=f694c617-3383-416c-91b6-b94fda371204", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-24", "reviewedAt": "2026-08-24" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "氟康唑怎样起作用：它抑制真菌合成麦角固醇所需的酶", "en": "How fluconazole works: it inhibits an enzyme fungi use to make ergosterol" }, "summary": { "zh": "FDA 标签将氟康唑描述为选择性抑制真菌细胞色素 P450 依赖的羊毛甾醇 14-α-去甲基化酶；该酶参与把羊毛甾醇转为麦角固醇。机制帮助理解它为何属于唑类抗真菌药，但不诊断感染、不能选择具体抗真菌药，也不决定个人剂量、剂型或疗程。", "en": "The FDA label describes fluconazole as a selective inhibitor of the fungal cytochrome-P450-dependent lanosterol 14-alpha-demethylase, an enzyme involved in converting lanosterol to ergosterol. This helps explain an azole antifungal mechanism; it does not diagnose infection, select an antifungal, or decide an individual's dose, dosage form or course." }, "checks": [ { "zh": "“影响真菌麦角固醇”不等于任何疑似真菌症状都由同一种病原或都适合氟康唑。是否为真菌感染、是否需要治疗及选择何种产品，仍需依据症状评估、检测（如适用）、既往情况和准确产品的现行标签。", "en": "“Affecting fungal ergosterol” does not mean that every suspected fungal symptom has the same cause or is suitable for fluconazole. Whether there is a fungal infection, whether treatment is needed and which product is appropriate still require symptom assessment, testing when relevant, prior context and the current label for the exact product." }, { "zh": "与其他唑类产品有相近机制，不表示可以自行叠加、轮换、序贯使用或按同样 mg 互相换算。产品名称、剂型、目标市场、完整药单与专业人员判断必须一起核对。", "en": "A related mechanism with another azole product does not permit self-combination, alternation, sequential use or milligram-for-milligram conversion. Product name, dosage form, target market, complete medicine list and professional assessment must be checked together." }, { "zh": "机制也不能消除氟康唑与其他药物发生相互作用或受肝肾情况影响的可能性。出现新的不适、正在多药并用，或考虑从片剂换成混悬液/其他产品时，应及时请药师或开方团队复核。", "en": "Mechanism does not remove the possibility of interactions with other medicines or effects of liver/kidney context. With a new concern, multiple medicines, or a plan to change from a tablet to a suspension or another product, seek timely review from a pharmacist or prescribing team." } ], "source": { "id": "src_6fabc885747065d9", "label": "DailyMed（NLM）：DIFLUCAN 氟康唑美国公开标签（Pfizer，2026-04 更新；临床药理）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=f694c617-3383-416c-91b6-b94fda371204", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-24", "reviewedAt": "2026-08-24" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "Diflucan", "generic": "氟康唑", "dosageFormClass": "口服片剂：50 mg、100 mg、150 mg、200 mg；口服混悬液：复溶后 10 mg/mL、40 mg/mL；另有静脉输注用制剂（DailyMed 2026-04 公开标签所列）" }, "labelSource": { "id": "src_6fabc885747065d9", "label": "DailyMed（NLM）：DIFLUCAN 氟康唑美国公开标签（Pfizer，2026-04 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=f694c617-3383-416c-91b6-b94fda371204", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-24", "reviewedAt": "2026-08-24" }, "productRoutes": [ { "source": { "id": "src_6fabc885747065d9", "label": "DailyMed（NLM）：DIFLUCAN 氟康唑美国公开标签（Pfizer，2026-04 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=f694c617-3383-416c-91b6-b94fda371204", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-24", "reviewedAt": "2026-08-24" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-24", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_bb1b1574eccdb2a0", "label": "FDA：DIFLUCAN 2011 美国历史标签（NDA 019949 / 019950 / 020090；不替代现行标签）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019949s055%2C019950s059%2C020090s038lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-24", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "DailyMed 的 DIFLUCAN（fluconazole）2026-04 美国公开标签列示 50 mg、100 mg、150 mg、200 mg 口服片，以及复溶后 10 mg/mL、40 mg/mL 口服混悬液和静脉输注用制剂。本页分别建立 50 mg、100 mg、200 mg 三个准确 30 片瓶装的品牌、通用名、每片强度、NDC、包装图和来源核对卡；不把包装数字变成个人片数、片剂与混悬液换算、联合用药、停换药或购买结论。", "history": "同一 DIFLUCAN 标签覆盖口服片、复溶后口服混悬液与静脉输注用制剂。片剂 mg 与混悬液 mg/mL 是不同的产品身份字段，不能只按通用名、相近数字或照片互相换算；150 mg 单片泡罩和其他包装也不等同于本页三个 30 片瓶装。", "sourceDocuments": [ { "id": "src_6fabc885747065d9", "label": "DailyMed（NLM）：DIFLUCAN 氟康唑美国公开标签（Pfizer，2026-04 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=f694c617-3383-416c-91b6-b94fda371204", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-24", "reviewedAt": "2026-08-24" }, { "id": "src_bb1b1574eccdb2a0", "label": "FDA：DIFLUCAN 2011 美国历史标签（NDA 019949 / 019950 / 020090；不替代现行标签）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019949s055%2C019950s059%2C020090s038lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_5ed30b676fbb9773", "label": "FDA Drugs@FDA 官方检索入口", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_lookup_entry", "documentKind": "regulatory_lookup", "market": "US", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } ], "applicationNumber": "NDA 019949 / 019950 / 020090", "approvalTimeline": [ { "date": "2026-04", "title": { "zh": "当前美国公开标签的日期记录", "en": "Dated current U.S. public-label record" }, "detail": { "zh": "本页链接 2026-04 的当前美国公开标签，作为放大阅读和逐项核对入口。它不替代目标市场当日的批准、供应、适应症、规格或个体化用药判断。", "en": "This page links the current U.S. public label dated 2026-04 as an enlarged-reading and item-by-item checking entry point. It does not replace same-day verification of approval, supply, indication, strength or individual use in the target market." }, "source": { "id": "src_6fabc885747065d9", "label": "DailyMed（NLM）：DIFLUCAN 氟康唑美国当前公开标签（Pfizer，2026-04 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=f694c617-3383-416c-91b6-b94fda371204", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-24", "reviewedAt": "2026-08-24" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "已链接当前公开标签", "en": "Current public label linked" }, "detail": { "zh": "仅对应本页所列的美国公开标签；不据此推定库存、可售资格或其他市场状态。", "en": "Only the U.S. public label listed on this page is linked; no stock, sale-eligibility or other-market conclusion is inferred." } }, { "market": { "zh": "中国大陆、欧盟、日本", "en": "Mainland China, EU, Japan" }, "status": { "zh": "待逐项建立市场记录", "en": "Market record not established" }, "detail": { "zh": "不从美国公开标签推定当地批准、持有人、规格、供应或可售资格。", "en": "No local approval, holder, strength, supply or sale-eligibility conclusion is inferred from the U.S. public label." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "当前美国标签能代表其他国家或地区吗？", "en": "Does a current U.S. label represent another country or region?" }, "answer": { "zh": "不能。它是逐项阅读入口；品牌、剂型、规格、可得性和安全信息仍须以目标市场的现行官方文件核对。", "en": "No. It is an item-by-item reading entry point; brand, dosage form, strength, availability and safety information still require checking against the target market's current official document." } }, { "question": { "zh": "为什么这里不展示价格或原研/仿制结论？", "en": "Why are price and originator/generic conclusions not shown?" }, "answer": { "zh": "这些结论需要产品、剂型、规格、包装、市场、日期和原始记录分别齐全并经人工审核；单一标签文件不足以支持。", "en": "Those conclusions require separately complete and human-reviewed product, dosage-form, strength, pack, market, date and primary-record fields; one label file is insufficient." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "dosage-forms-are-part-of-medicine-identity", "medicine-label-for-everyday-questions", "how-to-read-a-drug-label" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/diflucan/", "en": "https://origindrug.com/en/drugs/diflucan/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "vfend", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-25", "status": "published_traceable_archive" }, "names": { "brand": "Vfend", "generic": "伏立康唑", "aliases": [ "voriconazole" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "感染", "sourceArchiveMarket": "美国 FDA 2026 与 DailyMed 公开标签档案；本页分别建立 50 mg、200 mg 口服片，复溶后 40 mg/mL 口服混悬液和 200 mg 静脉用单剂量瓶的来源身份卡", "dosageFormClass": "50 mg、200 mg 口服片；40 mg/mL（200 mg/5 mL）复溶后口服混悬液；200 mg 静脉输注用单剂量瓶（FDA 2026 标签所列）", "dosageFormClassCode": "multiple_forms_and_routes", "route": "口服 / 静脉输注", "routeCode": "multiple", "historicalApprovalEntry": "2002（FDA 2026 标签所列美国初始批准）", "archiveSponsorText": "Roerig / FDA 与 DailyMed 公开监管标签档案" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-vfend-voriconazole-tablet-50mg-ndc-0049-3170-30", "marketCode": "US", "labelVersion": { "zh": "FDA 美国标签（2026-02 修订）", "en": "FDA U.S. label (revised February 2026)" }, "dosageForm": { "zh": "VFEND 伏立康唑口服薄膜衣片", "en": "VFEND voriconazole film-coated oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 0049-3170-30", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片 50 mg；30 片瓶装", "en": "50 mg per tablet; 30-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=vfend-15.jpg&setid=ce3ef5cf-3087-4d92-9d94-9eb8287228db&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "伏立康唑", "en": "voriconazole" }, "value": 50, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标示量；不是个人片数或调整指令", "en": "labelled amount per tablet; not an individual tablet count or adjustment instruction" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": null, "package": { "count": 30, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "白色", "en": "white" }, "shape": { "zh": "圆形薄膜衣片", "en": "round film-coated tablet" }, "imprint": "Pfizer / VOR50", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_e7c7f5157f315879", "label": "FDA：VFEND 2026 美国标签（50 mg 口服片、30 片瓶装；NDA 021267）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/021267s070lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-vfend-voriconazole-tablet-200mg-ndc-0049-3180-30", "marketCode": "US", "labelVersion": { "zh": "FDA 美国标签（2026-02 修订）", "en": "FDA U.S. label (revised February 2026)" }, "dosageForm": { "zh": "VFEND 伏立康唑口服薄膜衣片", "en": "VFEND voriconazole film-coated oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 0049-3180-30", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片 200 mg；30 片瓶装（标签文字身份）", "en": "200 mg per tablet; 30-tablet bottle (label-text identity)" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "伏立康唑", "en": "voriconazole" }, "value": 200, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标示量；不是个人片数或调整指令", "en": "labelled amount per tablet; not an individual tablet count or adjustment instruction" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": null, "package": { "count": 30, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "白色", "en": "white" }, "shape": { "zh": "胶囊形薄膜衣片", "en": "capsule-shaped film-coated tablet" }, "imprint": "Pfizer / VOR200", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_e7c7f5157f315879", "label": "FDA：VFEND 2026 美国标签（200 mg 口服片、30 片瓶装；NDA 021267）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/021267s070lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-vfend-voriconazole-oral-suspension-40mg-per-ml-ndc-0049-3160-44", "marketCode": "US", "labelVersion": { "zh": "FDA 美国标签（2026-02 修订）", "en": "FDA U.S. label (revised February 2026)" }, "dosageForm": { "zh": "VFEND 伏立康唑口服混悬液用粉（复溶后）", "en": "VFEND voriconazole powder for oral suspension (after reconstitution)" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 0049-3160-44", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_mL", "primaryDisplay": { "zh": "复溶后每 mL 含 40 mg（200 mg/5 mL）", "en": "40 mg per mL after reconstitution (200 mg/5 mL)" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "伏立康唑", "en": "voriconazole" }, "value": 40, "unit": "mg", "basisCode": "per_mL", "basisLabel": { "zh": "复溶后每 mL 浓度；不是个人毫升数或量取指令", "en": "concentration per mL after reconstitution; not an individual millilitre or measuring instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "100 mL HDPE 供货瓶", "en": "100 mL HDPE supplied bottle" }, "fill": { "value": 70, "unit": "mL" }, "countPerPackage": 1, "countUnit": { "zh": "瓶", "en": "bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": null, "package": { "count": 1, "unit": { "zh": "HDPE 瓶/包装", "en": "HDPE bottle per package" } }, "physicalClues": { "color": { "zh": "白色至类白色粉末；复溶后为白色至类白色混悬液", "en": "white to off-white powder; white to off-white suspension after reconstitution" }, "shape": { "zh": "口服液体制剂；不适用片剂外观", "en": "oral liquid formulation; tablet appearance not applicable" }, "imprint": "N/A", "scoreStatus": "not_applicable", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_e7c7f5157f315879", "label": "FDA：VFEND 2026 美国标签（复溶后口服混悬液 40 mg/mL；NDA 021267）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/021267s070lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-vfend-voriconazole-injection-200mg-ndc-0049-3190-28", "marketCode": "US", "labelVersion": { "zh": "FDA 美国标签（2026-02 修订）", "en": "FDA U.S. label (revised February 2026)" }, "dosageForm": { "zh": "VFEND 伏立康唑静脉用冻干粉", "en": "VFEND voriconazole lyophilised powder for intravenous use" }, "route": { "zh": "静脉输注（标签产品身份字段）", "en": "intravenous infusion (label product-identity field)" }, "routeCodes": [ "intravenous" ], "productCode": "NDC 0049-3190-28", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_vial", "primaryDisplay": { "zh": "每单剂量瓶含伏立康唑 200 mg（标签文字身份）", "en": "200 mg voriconazole per single-dose vial (label-text identity)" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "伏立康唑", "en": "voriconazole" }, "value": 200, "unit": "mg", "basisCode": "per_vial", "basisLabel": { "zh": "每瓶标示量；不是输注量或配制指令", "en": "labelled amount per vial; not an infusion amount or preparation instruction" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": null, "package": { "count": 1, "unit": { "zh": "单剂量瓶/包装", "en": "single-dose vial per package" } }, "physicalClues": { "color": { "zh": "无菌冻干粉", "en": "sterile lyophilised powder" }, "shape": { "zh": "单剂量瓶；不适用口服片外观", "en": "single-dose vial; oral-tablet appearance not applicable" }, "imprint": "N/A", "scoreStatus": "not_applicable", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_e7c7f5157f315879", "label": "FDA：VFEND 2026 美国标签（静脉用 200 mg 单剂量瓶；NDA 021267）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/021267s070lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": null, "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=vfend-15.jpg&setid=ce3ef5cf-3087-4d92-9d94-9eb8287228db&type=img", "alt": "VFEND 50 mg 伏立康唑片在美国 DailyMed 公开标签中的 Pfizer 30 片瓶装标签图", "archiveMarket": "美国", "labelVersion": "DailyMed 公开标签（Roerig，2026-02 更新）", "presentation": "VFEND 50 mg、30 片口服片瓶装标签图（NDC 0049-3170-30；DailyMed 公开标签所列；Pfizer 标签图）。", "notice": "此为美国 DailyMed 公开标签中明确对应 VFEND 50 mg、30 片口服片瓶装（NDC 0049-3170-30）的 Pfizer 标签图，只帮助核对品牌、通用名、标示强度、口服片、包装数量和来源；不用于鉴定真伪，也不证明 200 mg 片、40 mg/mL 复溶后口服混悬液、静脉输注用制剂、其他包装、其他市场标签、当前包装、原研身份、目标市场批准或可售资格。", "source": { "id": "src_423337f1dd7562d5", "label": "DailyMed（NLM）：VFEND 公开标签（Roerig，2026-02 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=ce3ef5cf-3087-4d92-9d94-9eb8287228db", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "VFEND 说明书放大阅读：片剂、口服混悬液与静脉输注不能仅按同名或 mg 互换", "en": "VFEND label reading: tablets, oral suspension and intravenous infusion are not exchanged by name or mg alone" }, "summary": { "zh": "本模块以 Roerig 的 DailyMed 2026-02 美国公开标签为阅读入口，帮助分开核对 VFEND 50 mg/200 mg 口服片、40 mg/mL 复溶后口服混悬液和静脉输注用制剂。图示仅为 50 mg、30 片瓶装（NDC 0049-3170-30）；不提供个人片数、毫升数、复溶、输注、疗程、转换或联用方案。", "en": "This module uses Roerig's February 2026 U.S. DailyMed public label as a reading entry point. It separates VFEND 50 mg/200 mg oral tablets, 40 mg/mL reconstituted oral suspension and intravenous infusion products. The visual is limited to the 50 mg, 30-tablet bottle (NDC 0049-3170-30); it does not provide an individual's tablet count, millilitres, reconstitution, infusion, course, switching or combination plan." }, "checks": [ { "zh": "50 mg、200 mg 是每片的标示强度；40 mg/mL 是复溶后口服混悬液的浓度；200 mg 静脉用单剂量瓶又是另一种制剂身份。它们不是同一种单位，也不能自行把“几片”换成“几毫升”、输注量或相互替代。", "en": "50 mg and 200 mg are labelled strength per tablet; 40 mg/mL is the concentration after oral-suspension reconstitution; the 200 mg single-dose intravenous vial is another formulation identity. They are not the same unit and do not support self-conversion from tablets to millilitres, an infusion amount or substitution." }, { "zh": "本页图示的 NDC 0049-3170-30、30 片与 50 mg 是同一美国瓶装的组合线索。包装外观、药片颜色、刻字或瓶装数量仅用于来源核对，不能鉴定真伪、推定其他强度可互换，或成为掰开、研碎、拼量的依据。", "en": "For this one U.S. bottle, NDC 0049-3170-30, 30 tablets and 50 mg are combined clues. Package appearance, tablet colour, debossing or bottle count only help check a source; they cannot authenticate a product, establish interchangeability with another strength, or justify splitting, crushing or combining." }, { "zh": "标签提示大量药物和草本相互作用，涉及 CYP2C19、CYP2C9、CYP3A4 等代谢通路。正在使用抗凝药、抗癫痫药、抑酸药、免疫相关药、草本或多种药时，应把所有实际包装交给药师或开方团队逐项复核；不能仅凭品牌名称、基因报告或网页决定是否同用。", "en": "The label flags many medicine and herbal interactions involving CYP2C19, CYP2C9 and CYP3A4 pathways. With an anticoagulant, antiseizure medicine, acid-suppressing medicine, immune-related medicine, herb or multiple medicines, have a pharmacist or prescribing team review every actual package item by item; brand names, a genetics report or a webpage cannot decide co-use." }, { "zh": "视觉变化、明显皮疹或日光相关皮肤变化、严重不适或对准确剂型不确定时，应及时使用当地医疗支持。不要从本页自行开始、重复、调整、转换或突然停止抗真菌治疗；本页只帮助读说明书的产品身份与风险线索。", "en": "With visual changes, marked rash or sunlight-related skin changes, serious illness or uncertainty about the exact dosage form, use timely local medical support. Do not self-start, repeat, adjust, switch or abruptly stop antifungal treatment from this page; it only helps read product-identity and risk clues in the label." } ], "source": { "id": "src_423337f1dd7562d5", "label": "DailyMed（NLM）：VFEND 公开标签（Roerig，2026-02 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=ce3ef5cf-3087-4d92-9d94-9eb8287228db", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "伏立康唑怎样起作用：它抑制真菌合成麦角固醇所需的 14α-羊毛甾醇去甲基化步骤", "en": "How voriconazole works: it inhibits a 14-alpha-lanosterol-demethylation step fungi use to make ergosterol" }, "summary": { "zh": "DailyMed 的 VFEND 标签将伏立康唑描述为唑类抗真菌药，其主要作用是抑制真菌细胞色素 P-450 介导的 14α-羊毛甾醇去甲基化；这是麦角固醇生物合成中的关键步骤。该机制帮助理解药物类别，不诊断真菌感染，也不决定个人是否需要治疗、产品选择、剂型、强度、疗程或停换方案。", "en": "The VFEND DailyMed label describes voriconazole as an azole antifungal whose primary action is inhibition of fungal cytochrome-P450-mediated 14-alpha-lanosterol demethylation, an essential step in ergosterol biosynthesis. This helps explain a drug class; it does not diagnose a fungal infection or decide an individual's need for treatment, product choice, dosage form, strength, course, stopping or switching." }, "checks": [ { "zh": "“影响真菌麦角固醇”不等于任何皮疹、口腔不适、咳嗽、发热或其他症状都由真菌造成，也不表示都适合伏立康唑。病因、检测（如适用）、目标市场标签与专业评估仍需分别完成。", "en": "“Affecting fungal ergosterol” does not mean every rash, oral concern, cough, fever or another symptom is fungal or suitable for voriconazole. Cause, testing when relevant, target-market labelling and professional assessment still need separate review." }, { "zh": "与其他唑类抗真菌药存在相近机制，或曾对另一种唑类有效/无效，都不能支持自行叠加、轮换、按 mg 换算、用余药续用或由此判断耐药。准确病原、产品、剂型、药物相互作用和专业团队的判断不可省略。", "en": "A related mechanism with another azole antifungal, or prior response/non-response to one, does not support self-combination, alternation, milligram conversion, use of leftovers or a conclusion about resistance. The exact organism, product, dosage form, interactions and professional assessment cannot be skipped." }, { "zh": "该标签还提示 CYP2C19 在伏立康唑代谢中有重要作用且存在遗传多态性；这解释为什么基因、肝功能和多种联用情况需要专业复核，但不表示每个人都应自行做全基因筛查，也不能由报告自行改变任何药物。", "en": "The label also notes that CYP2C19 is important in voriconazole metabolism and has genetic polymorphism. This explains why genetics, liver context and multiple co-medications need professional review, but it does not mean everyone should independently obtain broad genetic screening or change any medicine from a report." } ], "source": { "id": "src_423337f1dd7562d5", "label": "DailyMed（NLM）：VFEND 公开标签（Roerig，2026-02 更新；Microbiology / Clinical Pharmacology）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=ce3ef5cf-3087-4d92-9d94-9eb8287228db", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "Vfend", "generic": "伏立康唑", "dosageFormClass": "50 mg、200 mg 口服片；40 mg/mL（200 mg/5 mL）复溶后口服混悬液；200 mg 静脉输注用单剂量瓶（FDA 2026 标签所列）" }, "labelSource": { "id": "src_423337f1dd7562d5", "label": "DailyMed（NLM）：VFEND 公开标签（Roerig，2026-02 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=ce3ef5cf-3087-4d92-9d94-9eb8287228db", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "productRoutes": [ { "source": { "id": "src_423337f1dd7562d5", "label": "DailyMed（NLM）：VFEND 公开标签（Roerig，2026-02 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=ce3ef5cf-3087-4d92-9d94-9eb8287228db", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_e7c7f5157f315879", "label": "FDA：VFEND 2026 美国标签（NDA 021267）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/021267s070lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "FDA 2026 美国 VFEND（voriconazole）标签分别列出 50 mg、200 mg 口服片，复溶后 40 mg/mL（200 mg/5 mL）口服混悬液和 200 mg 静脉用制剂。本页把每一种剂型的单位、NDC、包装与标签外观线索分开阅读；它不把片剂 mg、液体 mg/mL 或静脉制剂 mg 变成任何人的片数、毫升数、复溶、输注、联用、转换或停药方案。", "history": "同一 VFEND 标签覆盖口服片、复溶后口服混悬液与静脉输注用制剂。共享通用名或相近总毫克数不建立剂型、量具、复溶、输注或个人使用上的可互换性；本页仅展示 50 mg 口服片的已核实官方包装面板，其他制剂保留为标签文字身份卡，须按准确包装、目标市场与现行标签分别核验。", "sourceDocuments": [ { "id": "src_423337f1dd7562d5", "label": "DailyMed（NLM）：VFEND 公开标签（Roerig，2026-02 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=ce3ef5cf-3087-4d92-9d94-9eb8287228db", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_e7c7f5157f315879", "label": "FDA：VFEND 2026 美国标签（NDA 021267）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/021267s070lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_5ed30b676fbb9773", "label": "FDA Drugs@FDA 官方检索入口", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_lookup_entry", "documentKind": "regulatory_lookup", "market": "US", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } ], "applicationNumber": "NDA 021267", "approvalTimeline": [ { "date": "2002", "title": { "zh": "FDA 标签所列美国初始批准年份", "en": "Initial U.S. approval year listed in the FDA label" }, "detail": { "zh": "本页链接的 FDA 标签档案列示 Initial U.S. Approval: 2002。该历史定位不等同于当前批准、可得性、持有人或其他市场状态。", "en": "The FDA label archive linked here lists Initial U.S. Approval: 2002. This historical locator is not a conclusion about current approval, availability, holder or another market." }, "source": { "id": "src_e7c7f5157f315879", "label": "FDA: VFEND prescribing information", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/021267s070lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, { "date": "2026-01", "title": { "zh": "FDA 标签档案版本", "en": "FDA label archive version" }, "detail": { "zh": "本页链接 2026-01 的 FDA 标签档案作为可复核阅读入口。现行标签、规格、适应症和安全信息必须另行以目标市场当前文件核对。", "en": "This page links the 2026-01 FDA label archive as a traceable reading entry point. Current labeling, strength, indication and safety information require separate verification against the target market’s current document." }, "source": { "id": "src_e7c7f5157f315879", "label": "FDA: VFEND prescribing information", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/021267s070lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "已链接公开标签档案", "en": "Public label archive linked" }, "detail": { "zh": "仅对应本页所列 FDA 文件。", "en": "Only the FDA document listed on this page is linked." } }, { "market": { "zh": "中国大陆、欧盟、日本", "en": "Mainland China, EU, Japan" }, "status": { "zh": "待逐项建立市场记录", "en": "Market record not established" }, "detail": { "zh": "不从美国标签档案推定当地批准、持有人、规格、供应或可售资格。", "en": "No local approval, holder, strength, supply or sale-eligibility conclusion is inferred from the U.S. label archive." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "标签档案能代表现在的产品信息吗？", "en": "Does a label archive represent current product information?" }, "answer": { "zh": "不能自动代表。档案用于定位来源；需要以目标市场的现行官方标签逐项复核。", "en": "Not automatically. The archive locates a source; each point needs verification against the target market’s current official label." } }, { "question": { "zh": "为什么这里不展示价格或原研/仿制结论？", "en": "Why are price and originator/generic conclusions not shown?" }, "answer": { "zh": "这些结论需要产品、剂型、规格、包装、市场、日期和原始记录分别齐全并经人工审核；单一标签文件不足以支持。", "en": "Those conclusions require separately complete and human-reviewed product, dosage-form, strength, pack, market, date and primary-record fields; one label file is insufficient." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "dosage-forms-are-part-of-medicine-identity", "medicine-label-for-everyday-questions", "how-to-read-a-drug-label" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/vfend/", "en": "https://origindrug.com/en/drugs/vfend/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "malarone", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-16", "status": "published_traceable_archive" }, "names": { "brand": "Malarone", "generic": "阿托伐醌/丙胍", "aliases": [ "MALARONE", "atovaquone", "proguanil hydrochloride", "阿托伐醌", "盐酸丙胍", "proguanil", "atovaquone and proguanil hydrochloride", "阿托伐醌/盐酸丙胍", "0173-0675-01", "GX CM3" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "感染", "sourceArchiveMarket": "美国公开监管档案", "dosageFormClass": "成人片与儿童片（FDA 2013 标签档案所列）", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "2000（FDA 2013 标签所列美国初始批准）", "archiveSponsorText": "FDA 公开监管档案" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [ "MALARONE adult-strength tablets 250 mg/100 mg" ], "excludedProductCues": [ "MALARONE pediatric tablets", "MALARONE paediatric tablets", "62.5 mg atovaquone", "25 mg proguanil hydrochloride", "NDC 0173-0676-01" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-malarone-atovaquone-proguanil-film-coated-tablet-adult-250mg-100mg-100ct-ndc-0173-0675-01", "marketCode": "US", "labelVersion": { "zh": "DailyMed 公开标签，2026-06-10 更新", "en": "DailyMed public label, updated 10 Jun 2026" }, "dosageForm": { "zh": "MALARONE 阿托伐醌/盐酸丙胍薄膜衣口服片（成人片）", "en": "MALARONE atovaquone/proguanil hydrochloride film-coated oral tablet (adult tablet)" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 0173-0675-01", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片阿托伐醌 250 mg／盐酸丙胍 100 mg；100 片儿童安全瓶装", "en": "Atovaquone 250 mg / proguanil hydrochloride 100 mg per tablet; 100-tablet child-resistant bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=malarone-spl-graphic-03.jpg&setid=fc22e8d8-3bfb-4f70-a599-dd81262a4887&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "阿托伐醌", "en": "atovaquone" }, "value": 250, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、预防或治疗方案", "en": "labelled amount per tablet; not an individual's tablet count, prevention or treatment plan" } }, { "ingredient": { "zh": "盐酸丙胍", "en": "proguanil hydrochloride" }, "value": 100, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、预防或治疗方案", "en": "labelled amount per tablet; not an individual's tablet count, prevention or treatment plan" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "100 片儿童安全瓶装", "en": "100-tablet child-resistant bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-24", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "粉红色", "en": "pink" }, "shape": { "zh": "圆形、双凸薄膜衣片", "en": "round, biconvex film-coated tablet" }, "imprint": "GX CM3", "scoreStatus": "not_scored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_625c68d495bcd278", "label": "DailyMed（NLM）：MALARONE 阿托伐醌/盐酸丙胍当前美国公开标签（GSK；2026-06-10 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=fc22e8d8-3bfb-4f70-a599-dd81262a4887", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": null, "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=malarone-spl-graphic-03.jpg&setid=fc22e8d8-3bfb-4f70-a599-dd81262a4887&type=img", "alt": "MALARONE 阿托伐醌/丙胍在美国 DailyMed GSK 公开标签中的成人片 100 片装标签图", "archiveMarket": "美国", "labelVersion": "DailyMed 公开标签（GSK，2026-06 修订；包装图稿 2024-01）", "presentation": "MALARONE 成人片：每片阿托伐醌 250 mg / 盐酸丙胍 100 mg、100 片装标签图（DailyMed GSK 公开标签所列）。", "notice": "此为美国 DailyMed GSK 公开标签中明确对应 MALARONE 成人片、每片阿托伐醌 250 mg / 盐酸丙胍 100 mg、100 片装的标签图，只帮助核对品牌、两个成分、成人片、标示强度、包装数量和来源；不用于鉴定真伪，也不证明儿童片、其他包装、其他市场标签、当前可得性、原研身份、目标市场批准或可售资格。", "source": { "id": "src_625c68d495bcd278", "label": "DailyMed（NLM）：MALARONE 公开标签（GSK，2026-06 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=fc22e8d8-3bfb-4f70-a599-dd81262a4887", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "MALARONE 说明书放大阅读：成人片和儿童片的两种成分不能只看总片数", "en": "MALARONE label reading: adult and paediatric tablets contain two components and cannot be read from tablet count alone" }, "summary": { "zh": "以 FDA 2013 MALARONE 美国标签为阅读入口，核对阿托伐醌/盐酸丙胍、成人片或儿童片、两种成分、包装和目标市场；不提供旅行前后个人预防或治疗用量、补服、换药或组合方案。", "en": "Using the FDA's 2013 U.S. MALARONE label as an entry point, this checks atovaquone/proguanil hydrochloride, adult or paediatric tablets, two components, package and target market; it does not provide an individual's prevention or treatment amount, make-up use, switching or combination plan." }, "checks": [ { "zh": "成人片标签标示每片阿托伐醌 250 mg 与盐酸丙胍 100 mg；儿童片是另一种两成分产品。品牌相同、片数相同或只看一个通用名，都不能证明可自行换算或互换。", "en": "The adult-tablet label states atovaquone 250 mg plus proguanil hydrochloride 100 mg per tablet; paediatric tablets are a different two-component product. A shared brand, tablet count or one generic name does not establish self-conversion or interchangeability." }, { "zh": "旅行目的地、暴露风险、疾病诊断、肝肾状况、妊娠可能性、呕吐腹泻和完整药单都会改变专业判断；不要凭旅行日期或网页自行开始、补服、延长、停止或与其他抗感染药叠加。", "en": "Destination, exposure risk, diagnosis, liver/kidney status, possible pregnancy, vomiting/diarrhoea and the complete medicine list affect professional judgement; do not self-start, make up, extend, stop or combine with another anti-infective from travel dates or a webpage." }, { "zh": "旅行中或返程后发热、寒战、意识变化、持续呕吐/腹泻、黄疸、呼吸困难或其他急性问题，应及时使用当地医疗支持，并说明旅行地点、日期及实际药盒。", "en": "With fever, chills, mental-status change, persistent vomiting/diarrhoea, jaundice, breathing difficulty or another acute issue during or after travel, use timely local medical support and report destinations, dates and the actual package." } ], "source": { "id": "src_ccdd1206c299d442", "label": "FDA：MALARONE 2013 美国标签（NDA 021078）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021078s022lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "阿托伐醌/丙胍怎样起作用：两个成分作用于寄生虫核酸复制所需的不同路径", "en": "How atovaquone/proguanil works: its two ingredients act on different pathways needed for parasite nucleic-acid replication" }, "summary": { "zh": "DailyMed 的 MALARONE 标签将其描述为阿托伐醌与盐酸丙胍的固定剂量复方抗疟药：阿托伐醌选择性抑制寄生虫线粒体电子传递；丙胍主要经代谢物环胍通过二氢叶酸还原酶发挥作用。这解释药理路径，不判断旅行地点是否有疟疾风险、是否需要预防或治疗、该选何种产品、个人剂量或疗程。", "en": "The DailyMed MALARONE label describes a fixed-dose antimalarial combination of atovaquone and proguanil hydrochloride: atovaquone selectively inhibits parasite mitochondrial electron transport, while proguanil acts mainly through cycloguanil, a dihydrofolate-reductase inhibitor. This explains a pharmacologic pathway; it does not determine travel risk, whether prevention or treatment is needed, product selection, an individual dose or course." }, "checks": [ { "zh": "“两个成分、两条路径”不表示可以自行用阿托伐醌、丙胍、其他抗疟药或余药拼配、加量、轮换或替代。旅行目的地、暴露时间、准确产品、体重相关信息、既往病史、完整药单和目标市场现行建议都需要专业人员一并确认。", "en": "“Two ingredients, two pathways” does not permit self-combining, increasing, alternating or substituting atovaquone, proguanil, another antimalarial or leftovers. Destination, exposure timing, exact product, weight-related information, history, complete medicine list and current target-market guidance all need professional confirmation together." }, { "zh": "机制不能让成人片与儿童片互相按片数或单个数字换算。固定剂量复方中每个成分、每片规格、适用人群与实际包装都是产品身份的一部分；不要从网页推导个人服用方案。", "en": "Mechanism cannot make adult and paediatric tablets interchangeable by tablet count or one number. In a fixed-dose combination, each ingredient, each tablet strength, the intended population and actual pack are all part of product identity; do not derive an individual regimen from a webpage." }, { "zh": "该标签列有与其他药物及严重不适相关的警示。正在使用抗凝药、抗感染药或多种药物，或出现持续呕吐、严重腹泻、皮疹、呼吸不适或其他急性问题时，应及时联系当地医疗支持；不要仅凭机制页面自行开始、补服、停用或换药。", "en": "The label includes warnings related to other medicines and serious symptoms. With anticoagulants, anti-infectives or multiple medicines, or persistent vomiting, severe diarrhoea, rash, breathing trouble or another acute concern, contact local medical support promptly; do not self-start, redose, stop or switch based only on a mechanism page." } ], "source": { "id": "src_625c68d495bcd278", "label": "DailyMed（NLM）：MALARONE 公开标签（GSK，2026-06 修订；临床药理/微生物学）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=fc22e8d8-3bfb-4f70-a599-dd81262a4887", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "Malarone", "generic": "阿托伐醌/丙胍", "dosageFormClass": "成人片与儿童片（FDA 2013 标签档案所列）" }, "labelSource": { "id": "src_ccdd1206c299d442", "label": "FDA：MALARONE 2013 美国标签（NDA 021078）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021078s022lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "productRoutes": [ { "source": { "id": "src_ccdd1206c299d442", "label": "FDA：MALARONE 2013 美国标签（NDA 021078）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021078s022lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "FDA 的 MALARONE（atovaquone and proguanil hydrochloride）2013 美国标签档案列示成人片与儿童片，并列出美国初始批准年份为 2000。此处仅提供可复核的美国历史监管文件入口，不推定其他市场的当前批准、规格、持有人、原研关系、供应或可售资格。", "history": "成人与儿童片为不同强度呈现，必须以实际包装、规格、市场和现行标签逐项核验。历史标签不是个体预防、治疗、处方或购买的依据。", "sourceDocuments": [ { "id": "src_ccdd1206c299d442", "label": "FDA：MALARONE 2013 美国标签（NDA 021078）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021078s022lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_5ed30b676fbb9773", "label": "FDA Drugs@FDA 官方检索入口", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_lookup_entry", "documentKind": "regulatory_lookup", "market": "US", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } ], "applicationNumber": "NDA 021078", "approvalTimeline": [ { "date": "2000", "title": { "zh": "FDA 标签所列美国初始批准年份", "en": "Initial U.S. approval year listed in the FDA label" }, "detail": { "zh": "本页链接的 FDA 标签档案列示 Initial U.S. Approval: 2000。该历史定位不等同于当前批准、可得性、持有人或其他市场状态。", "en": "The FDA label archive linked here lists Initial U.S. Approval: 2000. This historical locator is not a conclusion about current approval, availability, holder or another market." }, "source": { "id": "src_ccdd1206c299d442", "label": "FDA: MALARONE label archive", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021078s022lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, { "date": "2013-02", "title": { "zh": "FDA 标签档案版本", "en": "FDA label archive version" }, "detail": { "zh": "本页链接 2013-02 的 FDA 标签档案作为可复核阅读入口。现行标签、规格、适应症和安全信息必须另行以目标市场当前文件核对。", "en": "This page links the 2013-02 FDA label archive as a traceable reading entry point. Current labeling, strength, indication and safety information require separate verification against the target market’s current document." }, "source": { "id": "src_ccdd1206c299d442", "label": "FDA: MALARONE label archive", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021078s022lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "已链接公开标签档案", "en": "Public label archive linked" }, "detail": { "zh": "仅对应本页所列 FDA 文件。", "en": "Only the FDA document listed on this page is linked." } }, { "market": { "zh": "中国大陆、欧盟、日本", "en": "Mainland China, EU, Japan" }, "status": { "zh": "待逐项建立市场记录", "en": "Market record not established" }, "detail": { "zh": "不从美国标签档案推定当地批准、持有人、规格、供应或可售资格。", "en": "No local approval, holder, strength, supply or sale-eligibility conclusion is inferred from the U.S. label archive." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "标签档案能代表现在的产品信息吗？", "en": "Does a label archive represent current product information?" }, "answer": { "zh": "不能自动代表。档案用于定位来源；需要以目标市场的现行官方标签逐项复核。", "en": "Not automatically. The archive locates a source; each point needs verification against the target market’s current official label." } }, { "question": { "zh": "为什么这里不展示价格或原研/仿制结论？", "en": "Why are price and originator/generic conclusions not shown?" }, "answer": { "zh": "这些结论需要产品、剂型、规格、包装、市场、日期和原始记录分别齐全并经人工审核；单一标签文件不足以支持。", "en": "Those conclusions require separately complete and human-reviewed product, dosage-form, strength, pack, market, date and primary-record fields; one label file is insufficient." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "how-to-read-a-drug-label", "regulatory-sources-first" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/malarone/", "en": "https://origindrug.com/en/drugs/malarone/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "kaletra", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-25", "status": "published_traceable_archive" }, "names": { "brand": "Kaletra", "generic": "洛匹那韦/利托那韦", "aliases": [ "lopinavir", "ritonavir" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "感染", "sourceArchiveMarket": "美国 DailyMed 当前公开标签（2026-07-23 生效）：本页分别核对两种片剂与一种口服溶液的准确产品身份；不据此判断供应、库存、可得性或其他市场状态。", "dosageFormClass": "薄膜衣片：每片洛匹那韦/利托那韦 200 mg/50 mg 或 100 mg/25 mg；口服溶液：每mL 80 mg/20 mg（均为美国 2026 标签所列不同产品身份）", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "2000（AbbVie 2026 DailyMed 标签所列美国初始批准）", "archiveSponsorText": "AbbVie / FDA 公开标签与监管档案" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-kaletra-lopinavir-ritonavir-tablet-200mg-50mg-120-bottle-ndc-0074-4014-12", "marketCode": "US", "labelVersion": { "zh": "DailyMed 美国公开标签（2026-07-23 生效）", "en": "U.S. DailyMed public label (effective 23 Jul 2026)" }, "dosageForm": { "zh": "KALETRA 洛匹那韦/利托那韦薄膜衣片", "en": "KALETRA lopinavir/ritonavir film-coated tablet" }, "route": { "zh": "口服（标签产品身份字段）", "en": "oral (label product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 0074-4014-12", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片：洛匹那韦 200 mg + 利托那韦 50 mg；120 片瓶装", "en": "Per tablet: lopinavir 200 mg + ritonavir 50 mg; 120-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=kaletra-tablets-and-oral-solution-spl-05.jpg&setid=8290add3-4449-4e58-6c97-8fe1eec972e3&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "洛匹那韦", "en": "lopinavir" }, "value": 200, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数或调药规则", "en": "labelled amount per tablet; not an individual's tablet count or adjustment rule" } }, { "ingredient": { "zh": "利托那韦", "en": "ritonavir" }, "value": 50, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数或调药规则", "en": "labelled amount per tablet; not an individual's tablet count or adjustment rule" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 120, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-25", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 120, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "红色", "en": "red" }, "shape": { "zh": "椭圆形薄膜衣片", "en": "ovaloid film-coated tablet" }, "imprint": "AL", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_c80a3a01d0ab9c3d", "label": "DailyMed（NLM）：KALETRA 洛匹那韦/利托那韦当前美国公开标签（AbbVie；2026-07-23 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=8290add3-4449-4e58-6c97-8fe1eec972e3", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-25", "reviewedAt": "2026-08-25" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-kaletra-lopinavir-ritonavir-tablet-100mg-25mg-60-bottle-ndc-0074-3008-60", "marketCode": "US", "labelVersion": { "zh": "DailyMed 美国公开标签（2026-07-23 生效）", "en": "U.S. DailyMed public label (effective 23 Jul 2026)" }, "dosageForm": { "zh": "KALETRA 洛匹那韦/利托那韦薄膜衣片", "en": "KALETRA lopinavir/ritonavir film-coated tablet" }, "route": { "zh": "口服（标签产品身份字段）", "en": "oral (label product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 0074-3008-60", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片：洛匹那韦 100 mg + 利托那韦 25 mg；60 片瓶装", "en": "Per tablet: lopinavir 100 mg + ritonavir 25 mg; 60-tablet bottle" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "洛匹那韦", "en": "lopinavir" }, "value": 100, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数或调药规则", "en": "labelled amount per tablet; not an individual's tablet count or adjustment rule" } }, { "ingredient": { "zh": "利托那韦", "en": "ritonavir" }, "value": 25, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数或调药规则", "en": "labelled amount per tablet; not an individual's tablet count or adjustment rule" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 60, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-25", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 60, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "粉红色", "en": "pink" }, "shape": { "zh": "椭圆形薄膜衣片", "en": "ovaloid film-coated tablet" }, "imprint": "AC", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_c80a3a01d0ab9c3d", "label": "DailyMed（NLM）：KALETRA 洛匹那韦/利托那韦当前美国公开标签（AbbVie；2026-07-23 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=8290add3-4449-4e58-6c97-8fe1eec972e3", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-25", "reviewedAt": "2026-08-25" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-kaletra-lopinavir-ritonavir-oral-solution-80mg-20mg-per-ml-160ml-bottle-ndc-0074-3956-46", "marketCode": "US", "labelVersion": { "zh": "DailyMed 美国公开标签（2026-07-23 生效）", "en": "U.S. DailyMed public label (effective 23 Jul 2026)" }, "dosageForm": { "zh": "KALETRA 洛匹那韦/利托那韦口服溶液", "en": "KALETRA lopinavir/ritonavir oral solution" }, "route": { "zh": "口服（标签产品身份字段）", "en": "oral (label product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 0074-3956-46", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_mL", "primaryDisplay": { "zh": "每mL：洛匹那韦 80 mg + 利托那韦 20 mg；160 mL 瓶装", "en": "Per mL: lopinavir 80 mg + ritonavir 20 mg; 160 mL bottle" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "洛匹那韦", "en": "lopinavir" }, "value": 80, "unit": "mg", "basisCode": "per_mL", "basisLabel": { "zh": "每mL标签标示量；不是个人毫升数或换算规则", "en": "labelled amount per mL; not an individual's millilitre amount or conversion rule" } }, { "ingredient": { "zh": "利托那韦", "en": "ritonavir" }, "value": 20, "unit": "mg", "basisCode": "per_mL", "basisLabel": { "zh": "每mL标签标示量；不是个人毫升数或换算规则", "en": "labelled amount per mL; not an individual's millilitre amount or conversion rule" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "琥珀色多剂量瓶", "en": "amber multi-dose bottle" }, "fill": { "value": 160, "unit": "mL" }, "countPerPackage": null, "countUnit": null }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-25", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 1, "unit": { "zh": "瓶装", "en": "bottle" } }, "physicalClues": { "color": { "zh": "浅黄色至橙色液体", "en": "light-yellow to orange liquid" }, "shape": { "zh": "口服溶液；不是片剂", "en": "oral solution; not a tablet" }, "imprint": null, "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_c80a3a01d0ab9c3d", "label": "DailyMed（NLM）：KALETRA 洛匹那韦/利托那韦当前美国公开标签（AbbVie；2026-07-23 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=8290add3-4449-4e58-6c97-8fe1eec972e3", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-25", "reviewedAt": "2026-08-25" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": null, "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=kaletra-tablets-and-oral-solution-spl-05.jpg&setid=8290add3-4449-4e58-6c97-8fe1eec972e3&type=img", "alt": "KALETRA 洛匹那韦/利托那韦在美国 DailyMed AbbVie 公开标签中的 200 mg/50 mg、120 片薄膜衣片包装标签图", "archiveMarket": "美国", "labelVersion": "DailyMed 公开标签（AbbVie，2026-07 更新；包装图稿 2025）", "presentation": "KALETRA 薄膜衣片：每片洛匹那韦 200 mg / 利托那韦 50 mg、120 片装标签图（DailyMed AbbVie 公开标签所列）。", "notice": "此为美国 DailyMed AbbVie 公开标签中明确对应 KALETRA 薄膜衣片、每片洛匹那韦 200 mg / 利托那韦 50 mg、120 片装的标签图，只帮助核对品牌、两个成分、片剂、标示强度、包装数量和来源；不用于鉴定真伪，也不证明口服溶液、其他包装、其他市场标签、当前可得性、原研身份、目标市场批准或可售资格。", "source": { "id": "src_c80a3a01d0ab9c3d", "label": "DailyMed（NLM）：KALETRA 公开标签（AbbVie，2026-07 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=8290add3-4449-4e58-6c97-8fe1eec972e3", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-25", "reviewedAt": "2026-08-25" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "KALETRA 说明书放大阅读：片剂与口服液、两种成分和相互作用必须分别核对", "en": "KALETRA label reading: tablets, oral solution, two components and interactions must be checked separately" }, "summary": { "zh": "以 DailyMed KALETRA 美国公开标签为阅读入口，核对洛匹那韦/利托那韦、片剂或口服液、两种成分、包装和目标市场；不提供个人抗病毒方案、剂量、漏用处理、停药或与其他抗感染药的组合决定。", "en": "Using the U.S. DailyMed public label for KALETRA as an entry point, this checks lopinavir/ritonavir, tablet or oral solution, two components, package and target market; it does not provide an individual antiviral regimen, dose, missed-use handling, stopping or combination decision with another anti-infective." }, "checks": [ { "zh": "KALETRA 片剂与口服液不是同一种标示方式；成分、浓度、辅料、包装和处理要求需按准确制剂分别核对，不能把几片凭经验换成几毫升。", "en": "KALETRA tablets and oral solution are not labelled in the same way; components, concentration, excipients, package and handling must be checked for the exact formulation, and tablets cannot be converted to millilitres by experience." }, { "zh": "标签列有广泛相互作用线索。处方药、非处方药、草本、补充剂、降脂药、抗心律失常药、镇静药、抗凝药和其他抗感染药应交由 HIV/感染专科团队或药师逐项核对。", "en": "The label carries extensive interaction clues. Prescription and OTC medicines, herbs, supplements, lipid medicines, antiarrhythmics, sedatives, anticoagulants and other anti-infectives require item-by-item review by an HIV/infectious-disease team or pharmacist." }, { "zh": "黄疸样变化、严重腹痛、皮疹或水疱、昏厥/心悸、明显乏力、发热或其他急性问题时，应及时联系治疗团队或使用当地紧急医疗支持。", "en": "With jaundice-like changes, severe abdominal pain, rash or blistering, fainting/palpitations, marked weakness, fever or another acute concern, contact the treatment team promptly or use local urgent medical support." } ], "source": { "id": "src_c80a3a01d0ab9c3d", "label": "DailyMed（NLM）：KALETRA 公开标签", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=8290add3-4449-4e58-6c97-8fe1eec972e3", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-25", "reviewedAt": "2026-08-25" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "洛匹那韦/利托那韦怎样起作用：固定复方中利托那韦会影响洛匹那韦的代谢", "en": "How lopinavir/ritonavir works: in this fixed combination, ritonavir affects lopinavir metabolism" }, "summary": { "zh": "DailyMed 的 KALETRA 标签将其描述为洛匹那韦与利托那韦的固定剂量 HIV-1 抗病毒复方；其中利托那韦抑制 CYP3A 介导的洛匹那韦代谢，从而提高洛匹那韦血浆水平。这解释为何它的相互作用核对特别重要，但不决定个人是否适用、如何与其他抗病毒药联合、每次用量、剂型转换或停用。", "en": "The DailyMed KALETRA label describes a fixed-dose HIV-1 antiviral combination of lopinavir and ritonavir; ritonavir inhibits CYP3A-mediated metabolism of lopinavir, increasing lopinavir plasma levels. This helps explain why interaction review is particularly important, but does not decide individual suitability, combination with other antivirals, amount, dosage-form conversion or stopping." }, "checks": [ { "zh": "“利托那韦提高洛匹那韦水平”不是把两种单方药、另一种含利托那韦产品或其他抗病毒药自行叠加、替换或按毫克换算的依据。完整药单、具体制剂、肝肾情况与现行处方必须由熟悉相互作用的专业人员逐项核对。", "en": "“Ritonavir raises lopinavir levels” is not a basis for self-combining, substituting or milligram-converting separate ingredients, another ritonavir-containing product or another antiviral. The complete medicine list, exact formulation, liver/kidney context and current prescription need item-by-item review by a professional familiar with interactions." }, { "zh": "片剂与口服溶液不是仅因品牌和两种成分相同就能自行互换的同一操作。产品浓度、每单位含量、随餐要求、包装警示和目标市场的现行标签必须同实际处方一起核对。", "en": "Tablets and oral solution are not the same self-interchangeable operation merely because the brand and two ingredients match. Product concentration, amount per unit, food instructions, pack warnings and the current target-market label must be checked with the actual prescription." }, { "zh": "机制页面不能处理漏服、呕吐后补服、感染控制、QT/PR 间期风险或复杂联用。出现晕厥、心悸、明显乏力、黄疸、严重皮疹或其他急性问题时，应及时使用当地医疗支持，而不是依据网页自行改动。", "en": "A mechanism page cannot manage a missed dose, redosing after vomiting, infection control, QT/PR-interval risk or complex combinations. With fainting, palpitations, marked weakness, jaundice, severe rash or another acute concern, use timely local medical support rather than self-changing from a webpage." } ], "source": { "id": "src_c80a3a01d0ab9c3d", "label": "DailyMed（NLM）：KALETRA 公开标签（AbbVie，2026-07 修订；临床药理）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=8290add3-4449-4e58-6c97-8fe1eec972e3", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-25", "reviewedAt": "2026-08-25" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "Kaletra", "generic": "洛匹那韦/利托那韦", "dosageFormClass": "薄膜衣片：每片洛匹那韦/利托那韦 200 mg/50 mg 或 100 mg/25 mg；口服溶液：每mL 80 mg/20 mg（均为美国 2026 标签所列不同产品身份）" }, "labelSource": { "id": "src_c80a3a01d0ab9c3d", "label": "DailyMed（NLM）：KALETRA 公开标签（AbbVie，2026-07 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=8290add3-4449-4e58-6c97-8fe1eec972e3", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-25", "reviewedAt": "2026-08-25" }, "productRoutes": [ { "source": { "id": "src_c80a3a01d0ab9c3d", "label": "DailyMed（NLM）：KALETRA 公开标签（AbbVie，2026-07 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=8290add3-4449-4e58-6c97-8fe1eec972e3", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-25", "reviewedAt": "2026-08-25" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-25", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_cbb8a6033d330777", "label": "FDA：KALETRA 2013 美国历史标签（NDA 021251 / 021906）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021251s046_021906s039lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-25", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "AbbVie 的 KALETRA（lopinavir/ritonavir）2026-07 美国 DailyMed 公开标签列示两种薄膜衣片与一种口服溶液。本页把每片的两种 mg、口服溶液每mL的两种 mg、NDC、包装和标签外观分别呈现，帮助读者核对手中准确产品；不把这些数字变成个人片数、毫升数、漏用处理、换药或联合用药方案。", "history": "200 mg/50 mg 片、100 mg/25 mg 片和 80 mg/20 mg 每mL口服溶液是同一标签内三种不同产品身份。片剂的 mg 与溶液的 mg/mL 不能按品牌、两种成分相同或算术关系自行转换。任何市场的现行标签、完整药单、相互作用信息和专业使用决策必须另行核验。", "sourceDocuments": [ { "id": "src_c80a3a01d0ab9c3d", "label": "DailyMed（NLM）：KALETRA 公开标签（AbbVie，2026-07 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=8290add3-4449-4e58-6c97-8fe1eec972e3", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-25", "reviewedAt": "2026-08-25" }, { "id": "src_cbb8a6033d330777", "label": "FDA：KALETRA 2013 美国历史标签（NDA 021251 / 021906）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021251s046_021906s039lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_5ed30b676fbb9773", "label": "FDA Drugs@FDA 官方检索入口", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_lookup_entry", "documentKind": "regulatory_lookup", "market": "US", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } ], "applicationNumber": "NDA 021251 / 021906", "approvalTimeline": [ { "date": "2000", "title": { "zh": "FDA 标签所列美国初始批准年份", "en": "Initial U.S. approval year listed in the FDA label" }, "detail": { "zh": "本页链接的 FDA 标签档案列示 Initial U.S. Approval: 2000。该历史定位不等同于当前批准、可得性、持有人或其他市场状态。", "en": "The FDA label archive linked here lists Initial U.S. Approval: 2000. This historical locator is not a conclusion about current approval, availability, holder or another market." }, "source": { "id": "src_cbb8a6033d330777", "label": "FDA: KALETRA label archive", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021251s046_021906s039lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, { "date": "2013-01", "title": { "zh": "FDA 标签档案版本", "en": "FDA label archive version" }, "detail": { "zh": "本页链接 2013-01 的 FDA 标签档案作为可复核阅读入口。现行标签、规格、适应症和安全信息必须另行以目标市场当前文件核对。", "en": "This page links the 2013-01 FDA label archive as a traceable reading entry point. Current labeling, strength, indication and safety information require separate verification against the target market’s current document." }, "source": { "id": "src_cbb8a6033d330777", "label": "FDA: KALETRA label archive", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021251s046_021906s039lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "已链接公开标签档案", "en": "Public label archive linked" }, "detail": { "zh": "仅对应本页所列 FDA 文件。", "en": "Only the FDA document listed on this page is linked." } }, { "market": { "zh": "中国大陆、欧盟、日本", "en": "Mainland China, EU, Japan" }, "status": { "zh": "待逐项建立市场记录", "en": "Market record not established" }, "detail": { "zh": "不从美国标签档案推定当地批准、持有人、规格、供应或可售资格。", "en": "No local approval, holder, strength, supply or sale-eligibility conclusion is inferred from the U.S. label archive." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "标签档案能代表现在的产品信息吗？", "en": "Does a label archive represent current product information?" }, "answer": { "zh": "不能自动代表。档案用于定位来源；需要以目标市场的现行官方标签逐项复核。", "en": "Not automatically. The archive locates a source; each point needs verification against the target market’s current official label." } }, { "question": { "zh": "为什么这里不展示价格或原研/仿制结论？", "en": "Why are price and originator/generic conclusions not shown?" }, "answer": { "zh": "这些结论需要产品、剂型、规格、包装、市场、日期和原始记录分别齐全并经人工审核；单一标签文件不足以支持。", "en": "Those conclusions require separately complete and human-reviewed product, dosage-form, strength, pack, market, date and primary-record fields; one label file is insufficient." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "how-to-read-a-drug-label", "regulatory-sources-first" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/kaletra/", "en": "https://origindrug.com/en/drugs/kaletra/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "singulair", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-22", "status": "published_traceable_archive" }, "names": { "brand": "Singulair", "generic": "孟鲁司特钠", "aliases": [ "montelukast", "montelukast sodium", "孟鲁司特", "孟鲁司特钠", "孟鲁司特钠片", "顺尔宁" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": { "value": "顺尔宁®", "status": "discovery_cue_requires_target_market_verification", "source": { "id": "src_d92e446003face44", "label": "汉中市医疗保障局：2026 年常用药品价格监测中的顺尔宁／孟鲁司特钠片 10 mg×5 片记录", "url": "https://ybj.hanzhong.gov.cn/hzsylbzj/qsdt/202607/8fe1915213db4aea9b8bca1d4f473f1e.shtml", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "government_medicine_listing", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-12", "reviewedAt": "2026-09-12" } } }, "identity": { "therapeuticArea": "呼吸系统", "sourceArchiveMarket": "美国当前公开处方药标签（DailyMed SPL v5，2025-06-25 发布；本页只展示四个精确包装面板）", "dosageFormClass": "薄膜衣片、咀嚼片与口服颗粒（本档案所列）", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "未在本页推定（应按目标市场官方记录核验）", "archiveSponsorText": "DailyMed（NLM）公开标签档案" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-singulair-montelukast-sodium-oral-granules-4mg-30-packet-carton-ndc-78206-171-01", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v5（2025-06-25 发布）", "en": "DailyMed SPL v5 (published 25 Jun 2025)" }, "dosageForm": { "zh": "口服颗粒", "en": "oral granules" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 78206-171-01", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_packet", "primaryDisplay": { "zh": "孟鲁司特钠 4 mg 口服颗粒；30 袋纸盒", "en": "Montelukast sodium 4 mg oral granules; 30-packet carton" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=singulair-04.jpg&setid=482dcc92-b47f-4ea6-854a-f5ac2aea7842&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "孟鲁司特", "en": "montelukast" }, "value": 4, "unit": "mg", "basisCode": "per_packet", "basisLabel": { "zh": "每袋标签量；不是个人袋数、频率或混合方案", "en": "labelled amount per packet; not an individual's packet count, frequency or mixing plan" } } ], "concentration": null, "container": { "typeCode": "carton_with_child_resistant_foil_packets", "typeLabel": { "zh": "含儿童安全铝箔袋的纸盒", "en": "carton with child-resistant foil packets" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "袋/盒", "en": "packets per carton" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": null, "package": { "count": 30, "unit": { "zh": "袋/盒", "en": "packets per carton" } }, "physicalClues": { "color": { "zh": "白色", "en": "white" }, "shape": { "zh": "口服颗粒，单袋包装", "en": "oral granules in an individual packet" }, "imprint": null, "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_1f1ebd6211edd336", "label": "DailyMed（NLM）：SINGULAIR 孟鲁司特钠当前美国公开标签（Organon；SPL v5，2025-06-25 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=482dcc92-b47f-4ea6-854a-f5ac2aea7842", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-singulair-montelukast-sodium-chewable-tablet-4mg-30-bottle-ndc-78206-170-01", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v5（2025-06-25 发布）", "en": "DailyMed SPL v5 (published 25 Jun 2025)" }, "dosageForm": { "zh": "咀嚼片", "en": "chewable oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 78206-170-01", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "孟鲁司特钠 4 mg 咀嚼片；30 片瓶装", "en": "Montelukast sodium 4 mg chewable tablet; 30-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=singulair-05.jpg&setid=482dcc92-b47f-4ea6-854a-f5ac2aea7842&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "孟鲁司特", "en": "montelukast" }, "value": 4, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签量；不是个人片数、频率或换用方案", "en": "labelled amount per tablet; not an individual's tablet count, frequency or switching plan" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "高密度聚乙烯瓶", "en": "high-density polyethylene bottle" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": null, "package": { "count": 30, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "粉红色", "en": "pink" }, "shape": { "zh": "椭圆形双凸咀嚼片", "en": "oval biconvex chewable tablet" }, "imprint": "MSD 711 / SINGULAIR", "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_1f1ebd6211edd336", "label": "DailyMed（NLM）：SINGULAIR 孟鲁司特钠当前美国公开标签（Organon；SPL v5，2025-06-25 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=482dcc92-b47f-4ea6-854a-f5ac2aea7842", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-singulair-montelukast-sodium-chewable-tablet-5mg-30-bottle-ndc-78206-173-01", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v5（2025-06-25 发布）", "en": "DailyMed SPL v5 (published 25 Jun 2025)" }, "dosageForm": { "zh": "咀嚼片", "en": "chewable oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 78206-173-01", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "孟鲁司特钠 5 mg 咀嚼片；30 片瓶装", "en": "Montelukast sodium 5 mg chewable tablet; 30-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=singulair-06.jpg&setid=482dcc92-b47f-4ea6-854a-f5ac2aea7842&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "孟鲁司特", "en": "montelukast" }, "value": 5, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签量；不是个人片数、频率或换用方案", "en": "labelled amount per tablet; not an individual's tablet count, frequency or switching plan" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "高密度聚乙烯瓶", "en": "high-density polyethylene bottle" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": null, "package": { "count": 30, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "粉红色", "en": "pink" }, "shape": { "zh": "圆形双凸咀嚼片", "en": "round biconvex chewable tablet" }, "imprint": "MSD 275 / SINGULAIR", "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_1f1ebd6211edd336", "label": "DailyMed（NLM）：SINGULAIR 孟鲁司特钠当前美国公开标签（Organon；SPL v5，2025-06-25 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=482dcc92-b47f-4ea6-854a-f5ac2aea7842", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-singulair-montelukast-sodium-film-coated-tablet-10mg-30-bottle-ndc-78206-172-01", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v5（2025-06-25 发布）", "en": "DailyMed SPL v5 (published 25 Jun 2025)" }, "dosageForm": { "zh": "薄膜衣口服片", "en": "film-coated oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 78206-172-01", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "孟鲁司特钠 10 mg 薄膜衣片；30 片瓶装", "en": "Montelukast sodium 10 mg film-coated tablet; 30-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=singulair-07.jpg&setid=482dcc92-b47f-4ea6-854a-f5ac2aea7842&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "孟鲁司特", "en": "montelukast" }, "value": 10, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签量；不是个人片数、频率或换用方案", "en": "labelled amount per tablet; not an individual's tablet count, frequency or switching plan" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "高密度聚乙烯瓶", "en": "high-density polyethylene bottle" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": null, "package": { "count": 30, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "米色", "en": "beige" }, "shape": { "zh": "圆角方形薄膜衣片", "en": "rounded-square film-coated tablet" }, "imprint": "MSD 117 / SINGULAIR", "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_1f1ebd6211edd336", "label": "DailyMed（NLM）：SINGULAIR 孟鲁司特钠当前美国公开标签（Organon；SPL v5，2025-06-25 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=482dcc92-b47f-4ea6-854a-f5ac2aea7842", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-singulair-montelukast-sodium-oral-granules-4mg-30-packet-carton-ndc-78206-171-01", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=singulair-04.jpg&setid=482dcc92-b47f-4ea6-854a-f5ac2aea7842&type=img", "alt": "SINGULAIR 孟鲁司特钠在美国 DailyMed Organon 公开标签中的 4 mg 口服颗粒、30 袋装外盒展开图", "archiveMarket": "美国", "labelVersion": "DailyMed SPL v5（Organon，2025-06-25 发布）", "presentation": "SINGULAIR 孟鲁司特钠口服颗粒：每袋 4 mg、30 袋装外盒展开图（DailyMed Organon 公开标签所列）。", "notice": "此为美国 DailyMed Organon 公开标签中明确对应 SINGULAIR、孟鲁司特钠 4 mg 口服颗粒、30 袋装的外盒展开图，只帮助核对品牌、通用名、口服颗粒、标示强度、包装数量和来源；不用于鉴定真伪，也不证明咀嚼片、其他规格、其他包装、其他市场标签、当前可得性、原研身份、目标市场批准或可售资格。", "source": { "id": "src_1f1ebd6211edd336", "label": "DailyMed（NLM）：SINGULAIR 孟鲁司特钠当前美国公开标签（Organon；SPL v5，2025-06-25 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=482dcc92-b47f-4ea6-854a-f5ac2aea7842", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "SINGULAIR 说明书放大阅读：片剂、咀嚼片和口服颗粒是不同的产品形态", "en": "SINGULAIR label reading: tablets, chewables and oral granules are distinct product forms" }, "summary": { "zh": "本模块以美国 DailyMed 公开标签为阅读入口，帮助区分 SINGULAIR、孟鲁司特钠、薄膜衣片、咀嚼片、口服颗粒和目标市场。它不提供个人剂量、开始/停用、急性症状处理或与其他呼吸/过敏药的联用方案。", "en": "This module uses the U.S. DailyMed public label to distinguish SINGULAIR, montelukast sodium, film-coated tablets, chewable tablets, oral granules and target market. It does not provide individual dosing, start/stop, acute-symptom management or a combination plan with another respiratory/allergy medicine." }, "checks": [ { "zh": "先核对商品名 SINGULAIR、孟鲁司特钠、准确剂型、每单位标示强度和目标市场。相同通用名不能把薄膜衣片、咀嚼片与颗粒按片数、包数或经验自行换算或替换。", "en": "Check SINGULAIR, montelukast sodium, the exact form, stated strength per unit and target market together. A shared non-proprietary name does not make film-coated tablets, chewables and granules self-convertible or substitutable by tablet count, sachet count or experience." }, { "zh": "标签包含神经精神事件警示。出现新的或令人担忧的情绪、行为、睡眠或思维变化时，应及时按当地医疗渠道联系专业人员；不要仅凭网页自行停药、恢复用药、加量或改用另一种药。", "en": "The label includes a neuropsychiatric-events warning. With a new or concerning change in mood, behaviour, sleep or thinking, promptly contact a professional through local medical channels; do not self-stop, restart, increase or change to another medicine from a webpage." }, { "zh": "该标签也明确本品不用于逆转急性支气管痉挛。突然或加重的呼吸困难不应通过自行多用、等待网页回复或借用他人药物处理，而应按当地急救与医疗团队指引处置。", "en": "The label also says this product is not for reversal of acute bronchospasm. Sudden or worsening breathing difficulty should not be managed by self-escalation, waiting for a webpage or borrowing another person's medicine; use local emergency and care-team guidance." }, { "zh": "包装图、名称与“过敏/哮喘”用途文字只能帮助定位标签，不能证明真伪、当前批准或与另一种抗过敏、吸入或急救产品可互换。每次新增、停用或更换产品时，应让药师核对完整药单。", "en": "Package images, a name and “allergy/asthma” wording only help locate a label. They cannot authenticate a product, establish current approval or prove interchangeability with another allergy, inhaled or rescue product. Ask a pharmacist to review the complete medicine list with every addition, stop or change." } ], "source": { "id": "src_1f1ebd6211edd336", "label": "DailyMed（NLM）：SINGULAIR 孟鲁司特钠当前美国公开标签（Organon；SPL v5，2025-06-25 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=482dcc92-b47f-4ea6-854a-f5ac2aea7842", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "孟鲁司特怎样起作用：它阻断 CysLT1 白三烯受体，但不能替代急性呼吸处理", "en": "How montelukast works: it blocks the CysLT1 leukotriene receptor but does not replace acute breathing care" }, "summary": { "zh": "DailyMed 标签将孟鲁司特描述为口服活性白三烯受体拮抗剂，可高亲和力、选择性结合 CysLT1 受体。这个机制帮助读者理解药物类别和标签边界；它不能判断某个人的喘息、过敏症状、急性风险、产品选择或个人使用方式。", "en": "The DailyMed label describes montelukast as an orally active leukotriene receptor antagonist that binds the CysLT1 receptor with high affinity and selectivity. This mechanism helps explain drug class and label boundaries; it cannot judge an individual's wheeze, allergy symptoms, acute risk, product choice or use." }, "checks": [ { "zh": "“白三烯受体拮抗剂”是作用路径说明，不是把所有咳嗽、喘鸣、胸闷、鼻塞或皮疹自动归因于同一种病因，也不能替代诊断。", "en": "“Leukotriene receptor antagonist” describes an action pathway. It does not automatically attribute every cough, wheeze, chest tightness, congestion or rash to one cause, and it cannot replace diagnosis." }, { "zh": "共同的过敏或呼吸用途文字不使孟鲁司特与抗组胺药、吸入产品、急救药或另一种剂型可以自行叠加、替换或按毫克数换算。", "en": "Shared allergy or respiratory-use wording does not make montelukast self-combinable, substitutable or convertible by milligrams with an antihistamine, inhaled product, rescue medicine or another form." }, { "zh": "机制不能把非急性维持性产品变成突然或加重呼吸困难时的自行处理方案。出现急性症状、令人担忧的行为/情绪变化或需要改变用药时，应使用当地医疗渠道并携带完整药单。", "en": "Mechanism cannot turn a non-acute maintenance product into a self-management plan for sudden or worsening breathing difficulty. With acute symptoms, concerning behaviour/mood changes or a need to change use, use local medical pathways and bring the complete medicine list." } ], "source": { "id": "src_1f1ebd6211edd336", "label": "DailyMed（NLM）：SINGULAIR 孟鲁司特钠当前美国公开标签（临床药理；SPL v5，2025-06-25 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=482dcc92-b47f-4ea6-854a-f5ac2aea7842", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "Singulair", "generic": "孟鲁司特钠", "dosageFormClass": "薄膜衣片、咀嚼片与口服颗粒（本档案所列）" }, "labelSource": { "id": "src_1f1ebd6211edd336", "label": "DailyMed（NLM）：SINGULAIR 孟鲁司特钠当前美国公开标签（Organon；SPL v5，2025-06-25 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=482dcc92-b47f-4ea6-854a-f5ac2aea7842", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "productRoutes": [ { "source": { "id": "src_1f1ebd6211edd336", "label": "DailyMed（NLM）：SINGULAIR 孟鲁司特钠当前美国公开标签（Organon；SPL v5，2025-06-25 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=482dcc92-b47f-4ea6-854a-f5ac2aea7842", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [ { "id": "fda-2020-montelukast-boxed-warning-safety-communication", "issuedAt": "2020-03-04", "status": "fda_drug_safety_communication", "title": { "zh": "FDA 药物安全通讯：孟鲁司特（Singulair）精神健康相关风险的黑框警告", "en": "FDA Drug Safety Communication: Boxed Warning for mental-health effects with montelukast (Singulair)" }, "summary": { "zh": "FDA 于 2020-03-04 发布药物安全通讯，说明其在复核资料后要求孟鲁司特（Singulair 及仿制药）的处方信息加入精神与情绪相关不良反应的黑框警告，并要求新的患者用药指南；公告同时说明美国过敏性鼻炎用途的获益/风险考虑。这是特定日期的美国监管通讯，不等于对任何个人症状、适应症或当前治疗的结论。若出现新的或加重的情绪、行为或自伤想法，应立即寻求当地紧急/医疗支持；不要只根据本卡自行开始、停止、替换或调整药物。", "en": "On 2020-03-04, FDA issued a Drug Safety Communication saying that, after reviewing available information, it required a Boxed Warning in prescribing information for montelukast (Singulair and generics) about mental-health effects and a new patient Medication Guide; the communication also describes U.S. benefit-risk considerations for allergic rhinitis. This is a dated U.S. regulatory communication, not a conclusion about any person’s symptoms, indication or current treatment. New or worsening mood, behavior or self-harm thoughts require prompt local emergency or clinical support; do not self-start, stop, switch or adjust a medicine from this card alone." }, "source": { "id": "src_8f82989f9db6c83b", "label": "FDA：2020-03-04 孟鲁司特（Singulair）黑框警告药物安全通讯", "url": "https://www.fda.gov/drugs/drug-safety-communications/fda-requires-boxed-warning-about-serious-mental-health-side-effects-asthma-and-allergy-drug", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "DailyMed 的 SINGULAIR（montelukast sodium）当前美国公开标签列示口服薄膜衣片、咀嚼片和口服颗粒。本页只展示四个与官方包装面板一一对应的美国产品身份，帮助核对同一通用名下不同剂型、标示强度与包装；不生成个人服用数量、替代、联用或治疗方案。", "history": "4 mg 颗粒、4 mg 咀嚼片、5 mg 咀嚼片与 10 mg 薄膜衣片分别对应不同的标签产品形态。共同通用名或毫克数不表示可按片数、包数或经验互换；任何产品变化都应将准确产品、标签、年龄/病情资料和完整药单交由专业人员复核。", "sourceDocuments": [ { "id": "src_1f1ebd6211edd336", "label": "DailyMed（NLM）：SINGULAIR 孟鲁司特钠当前美国公开标签（Organon；SPL v5，2025-06-25 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=482dcc92-b47f-4ea6-854a-f5ac2aea7842", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_5ed30b676fbb9773", "label": "FDA Drugs@FDA 官方检索入口", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_lookup_entry", "documentKind": "regulatory_lookup", "market": "US", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } ], "applicationNumber": "NDA 020829 / 020830 / 021409", "approvalTimeline": [ { "date": "1998", "title": { "zh": "FDA 标签所列美国初始批准年份", "en": "Initial U.S. approval year listed in the FDA label" }, "detail": { "zh": "本页链接的 FDA 标签档案列示 Initial U.S. Approval: 1998。该历史定位不等同于当前批准、可得性、持有人或其他市场状态。", "en": "The FDA label archive linked here lists Initial U.S. Approval: 1998. This historical locator is not a conclusion about current approval, availability, holder or another market." }, "source": { "id": "src_1f1ebd6211edd336", "label": "DailyMed: SINGULAIR current public label", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=482dcc92-b47f-4ea6-854a-f5ac2aea7842", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, { "date": "DailyMed SPL v5, published 2025-06-25", "title": { "zh": "FDA 标签档案版本", "en": "FDA label archive version" }, "detail": { "zh": "本页链接 DailyMed SPL v5, published 2025-06-25 的 FDA 标签档案作为可复核阅读入口。现行标签、规格、适应症和安全信息必须另行以目标市场当前文件核对。", "en": "This page links the DailyMed SPL v5, published 2025-06-25 FDA label archive as a traceable reading entry point. Current labeling, strength, indication and safety information require separate verification against the target market’s current document." }, "source": { "id": "src_1f1ebd6211edd336", "label": "DailyMed: SINGULAIR current public label", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=482dcc92-b47f-4ea6-854a-f5ac2aea7842", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "已链接公开标签档案", "en": "Public label archive linked" }, "detail": { "zh": "仅对应本页所列 FDA 文件。", "en": "Only the FDA document listed on this page is linked." } }, { "market": { "zh": "中国大陆、欧盟、日本", "en": "Mainland China, EU, Japan" }, "status": { "zh": "待逐项建立市场记录", "en": "Market record not established" }, "detail": { "zh": "不从美国标签档案推定当地批准、持有人、规格、供应或可售资格。", "en": "No local approval, holder, strength, supply or sale-eligibility conclusion is inferred from the U.S. label archive." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "标签档案能代表现在的产品信息吗？", "en": "Does a label archive represent current product information?" }, "answer": { "zh": "不能自动代表。档案用于定位来源；需要以目标市场的现行官方标签逐项复核。", "en": "Not automatically. The archive locates a source; each point needs verification against the target market’s current official label." } }, { "question": { "zh": "为什么这里不展示价格或原研/仿制结论？", "en": "Why are price and originator/generic conclusions not shown?" }, "answer": { "zh": "这些结论需要产品、剂型、规格、包装、市场、日期和原始记录分别齐全并经人工审核；单一标签文件不足以支持。", "en": "Those conclusions require separately complete and human-reviewed product, dosage-form, strength, pack, market, date and primary-record fields; one label file is insufficient." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "how-to-read-a-drug-label", "regulatory-sources-first" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/singulair/", "en": "https://origindrug.com/en/drugs/singulair/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "ventolin-hfa", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-17", "status": "published_traceable_archive" }, "names": { "brand": "Ventolin HFA", "generic": "沙丁胺醇", "aliases": [ "albuterol", "albuterol sulfate", "salbutamol" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "呼吸系统", "sourceArchiveMarket": "美国公开处方药标签档案", "dosageFormClass": "定量吸入气雾剂；带计数器的吸入器（本档案所列）", "dosageFormClassCode": "inhaled_device", "route": "经口吸入", "routeCode": "inhalation", "historicalApprovalEntry": "1981（美国公开标签所列初始批准）", "archiveSponsorText": "DailyMed（NLM）公开标签档案" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-ventolin-hfa-albuterol-90mcg-actuation-200-inhalation-ndc-0173-0682-20", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国公开标签（2024-04-26 更新）", "en": "Current U.S. DailyMed public label (updated 26 Apr 2024)" }, "dosageForm": { "zh": "VENTOLIN HFA 沙丁胺醇定量吸入气雾剂", "en": "VENTOLIN HFA albuterol metered-dose inhalation aerosol" }, "route": { "zh": "经口吸入（标签产品身份字段）", "en": "oral inhalation (label product-identity field)" }, "routeCodes": [ "oral_inhalation" ], "productCode": "NDC 0173-0682-20", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_actuation_from_mouthpiece", "primaryDisplay": { "zh": "每次从口含器喷出相当于沙丁胺醇碱 90 mcg（硫酸沙丁胺醇 108 mcg）；蓝色带计数器吸入器；200 次定量吸入，18 g", "en": "Each actuation from the mouthpiece delivers 90 mcg albuterol base (equivalent to 108 mcg albuterol sulfate); blue inhaler with counter; 200 metered inhalations, 18 g" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=ventolinhfa-spl-graphic-15.jpg&setid=d92c5d6b-ff10-4087-36a2-1cfc464cb967", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "沙丁胺醇碱（每次从口含器喷出）", "en": "albuterol base (per actuation from mouthpiece)" }, "value": 90, "unit": "mcg", "basisCode": "per_actuation_from_mouthpiece", "basisLabel": { "zh": "每次定量喷射的标签标示量；不是个人吸入次数", "en": "labelled amount per metered actuation; not an individual inhalation count" } }, { "ingredient": { "zh": "硫酸沙丁胺醇（等量盐形式）", "en": "albuterol sulfate (equivalent salt form)" }, "value": 108, "unit": "mcg", "basisCode": "per_actuation_from_mouthpiece", "basisLabel": { "zh": "与 90 mcg 沙丁胺醇碱为同一次喷射的等量口径，不能相加", "en": "equivalent to 90 mcg albuterol base in the same actuation; do not add the values" } } ], "concentration": null, "container": { "typeCode": "metered_dose_inhaler", "typeLabel": { "zh": "蓝色带计数器定量吸入器", "en": "blue metered-dose inhaler with counter" }, "fill": { "value": 18, "unit": "g" }, "countPerPackage": null, "countUnit": null }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-28", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 200, "unit": { "zh": "次定量吸入/吸入器", "en": "metered inhalations per inhaler" } }, "physicalClues": { "color": { "zh": "蓝色吸入器与蓝色防尘盖", "en": "blue inhaler with blue cap" }, "shape": { "zh": "带剂量计数器的定量吸入器", "en": "metered-dose inhaler with dose counter" }, "imprint": null, "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_4939b25c2c864e50", "label": "DailyMed（NLM）：VENTOLIN HFA 沙丁胺醇定量吸入气雾剂当前美国公开标签（2024-04-26 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d92c5d6b-ff10-4087-36a2-1cfc464cb967", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": null, "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=ventolinhfa-spl-graphic-15.jpg&setid=d92c5d6b-ff10-4087-36a2-1cfc464cb967", "alt": "VENTOLIN HFA 沙丁胺醇定量吸入气雾剂在美国 DailyMed 公开标签中的 200 次定量吸入包装文字图", "archiveMarket": "美国", "labelVersion": "DailyMed 公开标签（GSK；2024-04 版本）", "presentation": "VENTOLIN HFA / 沙丁胺醇，90 mcg 每次喷射、200 次定量吸入包装文字图（DailyMed 公开标签所列）。", "notice": "此为美国 DailyMed 公开标签中明确对应 VENTOLIN HFA / 沙丁胺醇、每次喷射 90 mcg、200 次定量吸入的包装文字图，只帮助核对品牌、通用名、标示量、计数器、经口吸入途径和来源；不用于鉴定真伪，也不证明其他喷数、其他装置、其他市场标签、当前包装、原研身份、目标市场批准或可售资格。", "source": { "id": "src_4939b25c2c864e50", "label": "DailyMed（NLM）：VENTOLIN HFA 200 次定量吸入包装文字图（GSK 公开标签）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d92c5d6b-ff10-4087-36a2-1cfc464cb967", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "VENTOLIN HFA 说明书放大阅读：每喷 mcg、计数器和吸入器部件要一起看", "en": "VENTOLIN HFA label reading: read micrograms, counter and inhaler parts together" }, "summary": { "zh": "本模块以美国 DailyMed 公开标签和包装图为阅读入口，帮助区分 VENTOLIN HFA、沙丁胺醇、每次喷射的标示量、计数器和经口吸入途径。它不提供任何人的喷数、补喷、加量、换药或急性呼吸处理方案。", "en": "This module uses the U.S. DailyMed public label and package image to distinguish VENTOLIN HFA, albuterol, stated amount per actuation, the counter and oral-inhalation route. It does not provide an individual's puff count, extra-dose, escalation, switching or acute-breathing plan." }, "checks": [ { "zh": "先把 VENTOLIN HFA、沙丁胺醇、经口吸入、每次喷射标示量、包装所示计数器和目标市场一起核对。90 mcg 是这一个产品每次喷射的标示身份信息，不是网页给任何人计算今天应喷几次的答案。", "en": "Check VENTOLIN HFA, albuterol, oral inhalation, the stated amount per actuation, the package counter and target market together. The 90 mcg wording identifies one actuation of this product; it is not a web answer to how many times anyone should use it today." }, { "zh": "该标签提示此金属罐只应与 VENTOLIN HFA 执行器配合，执行器也不应与另一种吸入器的药罐混用。外观相近、同为蓝色或都写沙丁胺醇，不能证明部件可互换。", "en": "The label says this metal canister is to be used only with the VENTOLIN HFA actuator, and that actuator is not to be used with another inhaler's canister. Similar appearance, a blue colour or shared albuterol wording does not prove components are interchangeable." }, { "zh": "该标签将突然或加重的呼吸困难、咳嗽或喘鸣列为需及时医疗评估的问题；如果原本的产品不再缓解症状或需要比平时更频繁使用，应按当地医疗渠道及时寻求帮助，而不要从网页自行加量或借用他人吸入器。", "en": "The label identifies sudden or worsening breathing difficulty, cough or wheeze as reasons for prompt medical assessment. If the usual product no longer helps or is needed more often than usual, seek timely help through local care channels rather than self-escalating from a webpage or borrowing another person's inhaler." }, { "zh": "吸入药、哮喘药、β 受体阻滞剂、利尿剂、地高辛、部分抗抑郁药以及全部非处方产品和补充剂都可能影响需要核对的事项。开始、停用、联用或更换任何吸入产品前，应带完整药单与实际装置请药师或医生逐项确认。", "en": "Other inhaled or asthma medicines, beta blockers, diuretics, digoxin, some antidepressants, OTC products and supplements can all affect what requires review. Before starting, stopping, combining or changing an inhaled product, ask a pharmacist or clinician to check the complete medicine list and actual device." } ], "source": { "id": "src_4939b25c2c864e50", "label": "DailyMed（NLM）：VENTOLIN HFA 沙丁胺醇定量吸入气雾剂公开标签（GSK；2024-04 版本）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d92c5d6b-ff10-4087-36a2-1cfc464cb967", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "沙丁胺醇怎样起作用：标签描述其优先作用于气道平滑肌的 β2 肾上腺素能受体", "en": "How albuterol works: the label describes preferential action at beta2-adrenergic receptors in airway smooth muscle" }, "summary": { "zh": "DailyMed 标签描述沙丁胺醇优先作用于 β2 肾上腺素能受体；气道平滑肌受体被激活后涉及 cAMP 信号并导致平滑肌松弛。这个机制解释一条作用路径，但不能判断个人喘鸣原因、急性风险、吸入技术、喷数、联用或是否应更换产品。", "en": "The DailyMed label describes albuterol as acting preferentially at beta2-adrenergic receptors; activation in airway smooth muscle involves cAMP signalling and relaxation. This explains an action pathway, not the cause of an individual's wheeze, acute risk, inhaler technique, puff count, combination or a need to change product." }, "checks": [ { "zh": "“β2 受体”“气道放松”是标签的机制语言，不是把任何胸闷、咳嗽、气短或心悸自动归为同一疾病，也不替代诊断。", "en": "“Beta2 receptor” and “airway relaxation” are label mechanism terms. They do not attribute every chest symptom, cough, shortness of breath or palpitation to one disease and cannot replace diagnosis." }, { "zh": "标签也提示 β2 受体相关作用可能伴随心率、血压或其他心血管影响；机制名称不能用于自行判断个人能否加用、加量、与其他吸入药同服或换用另一种产品。", "en": "The label also notes that beta2-receptor-related action may be accompanied by pulse, blood-pressure or other cardiovascular effects. A mechanism name cannot decide whether an individual may add, increase, combine with another inhaler or change product." }, { "zh": "如果出现突然加重的呼吸问题、面部/口腔肿胀、晕厥、明显心悸或其他急性严重不适，应优先使用当地紧急医疗支持，而不是继续试验不同药物或装置。", "en": "With suddenly worsening breathing, swelling of the face or mouth, fainting, marked palpitations or another acute serious concern, prioritise local emergency care rather than experimenting with different medicines or devices." } ], "source": { "id": "src_4939b25c2c864e50", "label": "DailyMed（NLM）：VENTOLIN HFA 沙丁胺醇公开标签（临床药理）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d92c5d6b-ff10-4087-36a2-1cfc464cb967", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "Ventolin HFA", "generic": "沙丁胺醇", "dosageFormClass": "定量吸入气雾剂；带计数器的吸入器（本档案所列）" }, "labelSource": { "id": "src_4939b25c2c864e50", "label": "DailyMed（NLM）：VENTOLIN HFA 沙丁胺醇定量吸入气雾剂公开标签（GSK；2024-04 版本）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d92c5d6b-ff10-4087-36a2-1cfc464cb967", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "productRoutes": [ { "source": { "id": "src_4939b25c2c864e50", "label": "DailyMed（NLM）：VENTOLIN HFA 沙丁胺醇定量吸入气雾剂公开标签（GSK；2024-04 版本）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d92c5d6b-ff10-4087-36a2-1cfc464cb967", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "DailyMed 的 VENTOLIN HFA（albuterol sulfate）美国公开标签列示为经口吸入的定量气雾剂；主展示图标示每次喷射 90 mcg 沙丁胺醇（按沙丁胺醇碱计）与 200 次定量吸入。页面帮助读者把品牌、通用名、每喷标示、计数器、吸入途径与目标市场一起核对；不据此生成个人喷数、用药间隔、急性症状处理或换药方案。", "history": "“每喷 90 mcg”“200 次”“蓝色吸入器”都是这一个美国公开标签下的产品身份线索，不能据此确认其他国家包装、其他沙丁胺醇装置、个人用法或可替代性。喷雾罐与塑料执行器的匹配、标签版本和计数器状态也应与实际产品一起核对。", "sourceDocuments": [ { "id": "src_4939b25c2c864e50", "label": "DailyMed（NLM）：VENTOLIN HFA 沙丁胺醇定量吸入气雾剂公开标签（GSK；2024-04 版本）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d92c5d6b-ff10-4087-36a2-1cfc464cb967", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_5ed30b676fbb9773", "label": "FDA Drugs@FDA 官方检索入口", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_lookup_entry", "documentKind": "regulatory_lookup", "market": "US", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } ], "applicationNumber": "NDA 020983", "approvalTimeline": [ { "date": "1981", "title": { "zh": "FDA 标签所列美国初始批准年份", "en": "Initial U.S. approval year listed in the FDA label" }, "detail": { "zh": "本页链接的 FDA 标签档案列示 Initial U.S. Approval: 1981。该历史定位不等同于当前批准、可得性、持有人或其他市场状态。", "en": "The FDA label archive linked here lists Initial U.S. Approval: 1981. This historical locator is not a conclusion about current approval, availability, holder or another market." }, "source": { "id": "src_4939b25c2c864e50", "label": "DailyMed: VENTOLIN HFA public label archive", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d92c5d6b-ff10-4087-36a2-1cfc464cb967", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, { "date": "2024-04", "title": { "zh": "FDA 标签档案版本", "en": "FDA label archive version" }, "detail": { "zh": "本页链接 2024-04 的 FDA 标签档案作为可复核阅读入口。现行标签、规格、适应症和安全信息必须另行以目标市场当前文件核对。", "en": "This page links the 2024-04 FDA label archive as a traceable reading entry point. Current labeling, strength, indication and safety information require separate verification against the target market’s current document." }, "source": { "id": "src_4939b25c2c864e50", "label": "DailyMed: VENTOLIN HFA public label archive", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d92c5d6b-ff10-4087-36a2-1cfc464cb967", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "已链接公开标签档案", "en": "Public label archive linked" }, "detail": { "zh": "仅对应本页所列 FDA 文件。", "en": "Only the FDA document listed on this page is linked." } }, { "market": { "zh": "中国大陆、欧盟、日本", "en": "Mainland China, EU, Japan" }, "status": { "zh": "待逐项建立市场记录", "en": "Market record not established" }, "detail": { "zh": "不从美国标签档案推定当地批准、持有人、规格、供应或可售资格。", "en": "No local approval, holder, strength, supply or sale-eligibility conclusion is inferred from the U.S. label archive." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "标签档案能代表现在的产品信息吗？", "en": "Does a label archive represent current product information?" }, "answer": { "zh": "不能自动代表。档案用于定位来源；需要以目标市场的现行官方标签逐项复核。", "en": "Not automatically. The archive locates a source; each point needs verification against the target market’s current official label." } }, { "question": { "zh": "为什么这里不展示价格或原研/仿制结论？", "en": "Why are price and originator/generic conclusions not shown?" }, "answer": { "zh": "这些结论需要产品、剂型、规格、包装、市场、日期和原始记录分别齐全并经人工审核；单一标签文件不足以支持。", "en": "Those conclusions require separately complete and human-reviewed product, dosage-form, strength, pack, market, date and primary-record fields; one label file is insufficient." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "how-to-read-a-drug-label", "regulatory-sources-first" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/ventolin-hfa/", "en": "https://origindrug.com/en/drugs/ventolin-hfa/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "symbicort", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-17", "status": "published_traceable_archive" }, "names": { "brand": "Symbicort", "generic": "布地奈德/福莫特罗", "aliases": [ "budesonide", "formoterol", "formoterol fumarate", "budesonide formoterol" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "呼吸系统", "sourceArchiveMarket": "美国公开处方药历史标签档案", "dosageFormClass": "复方定量吸入气雾剂；80/4.5 与 160/4.5（本档案所列）", "dosageFormClassCode": "inhaled_device", "route": "经口吸入", "routeCode": "inhalation", "historicalApprovalEntry": "2006（美国公开历史标签所列初始批准）", "archiveSponsorText": "DailyMed（NLM）公开历史标签档案" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-symbicort-budesonide-80mcg-formoterol-4-5mcg-120-inhalations-0186037220", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v31（2024-11-20 发布）", "en": "DailyMed SPL v31 (published 20 Nov 2024)" }, "dosageForm": { "zh": "SYMBICORT 布地奈德/富马酸福莫特罗二水合物定量吸入气雾剂", "en": "SYMBICORT budesonide/formoterol fumarate dihydrate metered-dose inhalation aerosol" }, "route": { "zh": "经口吸入（标签产品身份字段）", "en": "oral inhalation (label product-identity field)" }, "routeCodes": [ "oral_inhalation" ], "productCode": "NDC 0186-0372-20", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_inhalation", "primaryDisplay": { "zh": "每次吸入：布地奈德 80 mcg + 福莫特罗 4.5 mcg；120 次定量吸入", "en": "Per inhalation: budesonide 80 mcg + formoterol 4.5 mcg; 120 metered inhalations" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=image-17.jpg&setid=fafa4cf1-99c2-43d5-73ad-51f256de3be0", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "布地奈德", "en": "budesonide" }, "value": 80, "unit": "mcg", "basisCode": "per_inhalation", "basisLabel": { "zh": "同一次吸入中的第一种标签成分；不是个人吸入次数", "en": "first labelled ingredient in the same inhalation; not an individual's inhalation count" } }, { "ingredient": { "zh": "福莫特罗（按富马酸福莫特罗二水合物计）", "en": "formoterol (as formoterol fumarate dihydrate)" }, "value": 4.5, "unit": "mcg", "basisCode": "per_inhalation", "basisLabel": { "zh": "同一次吸入中的第二种标签成分；两个数字不能相加为个人用量", "en": "second labelled ingredient in the same inhalation; the two numbers must not be added as an individual amount" } } ], "concentration": null, "container": { "typeCode": "metered_dose_inhaler", "typeLabel": { "zh": "红色塑料驱动器、白色口含器、灰色防尘盖，带计数器", "en": "red plastic actuator, white mouthpiece, gray dust cap and counter" }, "fill": null, "countPerPackage": null, "countUnit": null }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-28", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 120, "unit": { "zh": "次定量吸入/吸入器", "en": "metered inhalations per inhaler" } }, "physicalClues": { "color": { "zh": "红色驱动器、白色口含器、灰色防尘盖", "en": "red actuator, white mouthpiece and gray dust cap" }, "shape": { "zh": "带剂量计数器的定量吸入器与纸盒", "en": "metered-dose inhaler with counter and carton" }, "imprint": null, "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_7ed5285b16c9aa47", "label": "DailyMed（NLM）：SYMBICORT 当前美国公开标签（AstraZeneca；SPL v31）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=fafa4cf1-99c2-43d5-73ad-51f256de3be0", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-symbicort-budesonide-160mcg-formoterol-4-5mcg-120-inhalations-0186037020", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v31（2024-11-20 发布）", "en": "DailyMed SPL v31 (published 20 Nov 2024)" }, "dosageForm": { "zh": "SYMBICORT 布地奈德/富马酸福莫特罗二水合物定量吸入气雾剂", "en": "SYMBICORT budesonide/formoterol fumarate dihydrate metered-dose inhalation aerosol" }, "route": { "zh": "经口吸入（标签产品身份字段）", "en": "oral inhalation (label product-identity field)" }, "routeCodes": [ "oral_inhalation" ], "productCode": "NDC 0186-0370-20", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_inhalation", "primaryDisplay": { "zh": "每次吸入：布地奈德 160 mcg + 福莫特罗 4.5 mcg；120 次定量吸入", "en": "Per inhalation: budesonide 160 mcg + formoterol 4.5 mcg; 120 metered inhalations" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=image-16.jpg&setid=fafa4cf1-99c2-43d5-73ad-51f256de3be0", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "布地奈德", "en": "budesonide" }, "value": 160, "unit": "mcg", "basisCode": "per_inhalation", "basisLabel": { "zh": "同一次吸入中的第一种标签成分；不是个人吸入次数", "en": "first labelled ingredient in the same inhalation; not an individual's inhalation count" } }, { "ingredient": { "zh": "福莫特罗（按富马酸福莫特罗二水合物计）", "en": "formoterol (as formoterol fumarate dihydrate)" }, "value": 4.5, "unit": "mcg", "basisCode": "per_inhalation", "basisLabel": { "zh": "同一次吸入中的第二种标签成分；两个数字不能相加为个人用量", "en": "second labelled ingredient in the same inhalation; the two numbers must not be added as an individual amount" } } ], "concentration": null, "container": { "typeCode": "metered_dose_inhaler", "typeLabel": { "zh": "红色塑料驱动器、白色口含器、灰色防尘盖，带计数器", "en": "red plastic actuator, white mouthpiece, gray dust cap and counter" }, "fill": null, "countPerPackage": null, "countUnit": null }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-28", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 120, "unit": { "zh": "次定量吸入/吸入器", "en": "metered inhalations per inhaler" } }, "physicalClues": { "color": { "zh": "红色驱动器、白色口含器、灰色防尘盖", "en": "red actuator, white mouthpiece and gray dust cap" }, "shape": { "zh": "带剂量计数器的定量吸入器与纸盒", "en": "metered-dose inhaler with counter and carton" }, "imprint": null, "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_7ed5285b16c9aa47", "label": "DailyMed（NLM）：SYMBICORT 当前美国公开标签（AstraZeneca；SPL v31）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=fafa4cf1-99c2-43d5-73ad-51f256de3be0", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": null, "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=image-16.jpg&setid=fafa4cf1-99c2-43d5-73ad-51f256de3be0", "alt": "SYMBICORT 布地奈德/福莫特罗 160/4.5 定量吸入气雾剂在美国 DailyMed AstraZeneca 公开历史标签中的 120 次吸入纸盒图", "archiveMarket": "美国", "labelVersion": "DailyMed 公开历史标签（AstraZeneca，2017-12 修订）", "presentation": "SYMBICORT 160/4.5、120 次吸入定量气雾剂纸盒图（DailyMed 公开历史标签所列；AstraZeneca 文件）。", "notice": "此图仅作公开历史标签的产品身份阅读线索，不用于鉴定真伪、确认当前批准或推断其他强度、包装、市场或个人用法。", "source": { "id": "src_7ed5285b16c9aa47", "label": "DailyMed（NLM）：SYMBICORT 布地奈德/福莫特罗定量吸入气雾剂公开历史标签（AstraZeneca；2017-12 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=fafa4cf1-99c2-43d5-73ad-51f256de3be0", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "SYMBICORT 说明书放大阅读：80/4.5 与 160/4.5 是两个成分加一个装置的身份信息", "en": "SYMBICORT label reading: 80/4.5 and 160/4.5 identify two ingredients in one device" }, "summary": { "zh": "本模块以美国 DailyMed 公开历史标签和包装图为阅读入口，帮助核对 SYMBICORT、布地奈德、福莫特罗、每次喷射的双数字、定量吸入包装和经口吸入途径。它不提供任何人的喷数、增量、替换或急性呼吸处理方案。", "en": "This module uses the U.S. DailyMed public historical label and package image to check SYMBICORT, budesonide, formoterol, the two per-actuation numbers, metered-inhalation package and oral-inhalation route. It does not provide an individual's puff count, escalation, substitution or acute-breathing plan." }, "checks": [ { "zh": "先把 SYMBICORT、布地奈德/福莫特罗、准确的 80/4.5 或 160/4.5 标示、每次喷射、包装所示吸入次数和目标市场一起核对。页面中的数字是这一个产品身份字段，不是网页给任何人计算今天应喷几次的答案。", "en": "Check SYMBICORT, budesonide/formoterol, the exact 80/4.5 or 160/4.5 wording, each actuation, stated inhalation count and target market together. These numbers are identity fields for one product, not a web answer to how many times anyone should use it today." }, { "zh": "80/4.5 与 160/4.5 的第一个数字对应复方中的布地奈德标示；不能只比第一个数字，就自行换强度、把两盒拼用，或把另一种吸入药按相似数字换算。", "en": "In 80/4.5 and 160/4.5, the first number is the budesonide marking within the combination. Do not compare only that number to self-change strength, combine packs or convert another inhaler by a similar-looking number." }, { "zh": "这份历史标签将该产品与急性支气管痉挛的即时缓解区分开来。突然或加重的呼吸困难、咳嗽或喘鸣，应按当地紧急医疗和既有照护指引及时处理，而不要据网页自行连续补喷、叠加装置或借用他人产品。", "en": "This historical label distinguishes the product from immediate relief of acute bronchospasm. Sudden or worsening breathing difficulty, cough or wheeze needs timely action through local emergency and existing care guidance, not repeated self-dosing, device stacking or borrowing another person's product from a webpage." }, { "zh": "现有吸入药、其他哮喘或过敏药、β 受体阻滞剂、利尿剂、部分抗抑郁药以及全部非处方产品和补充剂，都应与实际装置和完整药单一起交由药师或医生核对。不要因为含有其中一个成分而自行加用、拆分或更换复方产品。", "en": "Existing inhalers, other asthma or allergy medicines, beta blockers, diuretics, some antidepressants, OTC products and supplements should be reviewed with the actual device and complete medicine list by a pharmacist or clinician. Do not add, split or change a combination product yourself because it shares one ingredient." } ], "source": { "id": "src_7ed5285b16c9aa47", "label": "DailyMed（NLM）：SYMBICORT 布地奈德/福莫特罗定量吸入气雾剂公开历史标签（AstraZeneca；2017-12 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=fafa4cf1-99c2-43d5-73ad-51f256de3be0", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "布地奈德/福莫特罗怎样起作用：标签描述一个抗炎皮质激素成分与一个长效 β2 受体激动剂成分", "en": "How budesonide/formoterol works: the label describes an anti-inflammatory corticosteroid ingredient and a long-acting beta2-agonist ingredient" }, "summary": { "zh": "DailyMed 历史标签将布地奈德描述为糖皮质激素成分，将福莫特罗描述为长效 β2 肾上腺素能受体激动剂成分。它们的机制文字用于理解复方的两条作用路径；不用于判断个人症状原因、急性风险、吸入技术、喷数、联用或是否应更换产品。", "en": "The DailyMed historical label describes budesonide as a glucocorticosteroid ingredient and formoterol as a long-acting beta2-adrenergic agonist ingredient. The mechanism text helps explain two action pathways in a combination; it does not determine the cause of an individual's symptoms, acute risk, inhaler technique, puff count, combination or switching." }, "checks": [ { "zh": "“抗炎”“长效 β2 激动剂”是标签的机制语言，不会把任何咳嗽、胸闷、喘鸣或心悸自动归入同一种疾病，也不能替代诊断。", "en": "“Anti-inflammatory” and “long-acting beta2 agonist” are label mechanism terms. They do not attribute every cough, chest symptom, wheeze or palpitation to one disease and cannot replace diagnosis." }, { "zh": "“长效”不表示该产品可作为急性症状的网页自助方案，也不表示它与 VENTOLIN HFA 或任何其他吸入产品可凭机制名称、颜色或喷数互换。", "en": "“Long-acting” does not turn the product into a web-guided plan for acute symptoms, nor establish interchangeability with VENTOLIN HFA or another inhaler from a mechanism name, colour or puff count." }, { "zh": "复方机制也不支持把布地奈德、福莫特罗或其他吸入产品自行另加、拆分、轮换或改变强度。出现呼吸急剧加重、面部或口腔肿胀、晕厥、明显心悸或其他急性严重不适时，应优先使用当地紧急医疗支持。", "en": "Combination mechanism does not support self-adding, separating, alternating or changing the strength of budesonide, formoterol or another inhaled product. With rapidly worsening breathing, face or mouth swelling, fainting, marked palpitations or another acute serious concern, prioritise local emergency care." } ], "source": { "id": "src_7ed5285b16c9aa47", "label": "DailyMed（NLM）：SYMBICORT 布地奈德/福莫特罗公开历史标签（临床药理）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=fafa4cf1-99c2-43d5-73ad-51f256de3be0", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "Symbicort", "generic": "布地奈德/福莫特罗", "dosageFormClass": "复方定量吸入气雾剂；80/4.5 与 160/4.5（本档案所列）" }, "labelSource": { "id": "src_7ed5285b16c9aa47", "label": "DailyMed（NLM）：SYMBICORT 布地奈德/福莫特罗定量吸入气雾剂公开历史标签（AstraZeneca；2017-12 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=fafa4cf1-99c2-43d5-73ad-51f256de3be0", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "productRoutes": [ { "source": { "id": "src_7ed5285b16c9aa47", "label": "DailyMed（NLM）：SYMBICORT 布地奈德/福莫特罗定量吸入气雾剂公开历史标签（AstraZeneca；2017-12 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=fafa4cf1-99c2-43d5-73ad-51f256de3be0", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "DailyMed 的 SYMBICORT（budesonide/formoterol fumarate）美国公开历史标签列示为经口吸入的复方定量气雾剂；标签包含 80/4.5 与 160/4.5 两种每次喷射标示，以及 60 次或 120 次定量吸入包装。页面帮助读者把双成分、成分各自的数字、装置、包装次数和目标市场一起核对；不据此生成个人喷数、加量、急性症状处理或换药方案。", "history": "“80/4.5”“160/4.5”不是一个可单独比较或自行换算的总量数字，而是同一复方装置中两个成分的每次喷射标示。另一种强度、另一种吸入器、另一个市场或另一份标签都需要重新逐项核对，不能凭品牌、颜色、相似数字或共同成分推定可以互换。", "sourceDocuments": [ { "id": "src_7ed5285b16c9aa47", "label": "DailyMed（NLM）：SYMBICORT 布地奈德/福莫特罗定量吸入气雾剂公开历史标签（AstraZeneca；2017-12 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=fafa4cf1-99c2-43d5-73ad-51f256de3be0", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_5ed30b676fbb9773", "label": "FDA Drugs@FDA 官方检索入口", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_lookup_entry", "documentKind": "regulatory_lookup", "market": "US", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } ], "applicationNumber": "NDA 021929", "approvalTimeline": [ { "date": "2006", "title": { "zh": "FDA 标签所列美国初始批准年份", "en": "Initial U.S. approval year listed in the FDA label" }, "detail": { "zh": "本页链接的 FDA 标签档案列示 Initial U.S. Approval: 2006。该历史定位不等同于当前批准、可得性、持有人或其他市场状态。", "en": "The FDA label archive linked here lists Initial U.S. Approval: 2006. This historical locator is not a conclusion about current approval, availability, holder or another market." }, "source": { "id": "src_7ed5285b16c9aa47", "label": "DailyMed: SYMBICORT public label archive", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=fafa4cf1-99c2-43d5-73ad-51f256de3be0", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, { "date": "2017-12", "title": { "zh": "FDA 标签档案版本", "en": "FDA label archive version" }, "detail": { "zh": "本页链接 2017-12 的 FDA 标签档案作为可复核阅读入口。现行标签、规格、适应症和安全信息必须另行以目标市场当前文件核对。", "en": "This page links the 2017-12 FDA label archive as a traceable reading entry point. Current labeling, strength, indication and safety information require separate verification against the target market’s current document." }, "source": { "id": "src_7ed5285b16c9aa47", "label": "DailyMed: SYMBICORT public label archive", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=fafa4cf1-99c2-43d5-73ad-51f256de3be0", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "已链接公开标签档案", "en": "Public label archive linked" }, "detail": { "zh": "仅对应本页所列 FDA 文件。", "en": "Only the FDA document listed on this page is linked." } }, { "market": { "zh": "中国大陆、欧盟、日本", "en": "Mainland China, EU, Japan" }, "status": { "zh": "待逐项建立市场记录", "en": "Market record not established" }, "detail": { "zh": "不从美国标签档案推定当地批准、持有人、规格、供应或可售资格。", "en": "No local approval, holder, strength, supply or sale-eligibility conclusion is inferred from the U.S. label archive." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "标签档案能代表现在的产品信息吗？", "en": "Does a label archive represent current product information?" }, "answer": { "zh": "不能自动代表。档案用于定位来源；需要以目标市场的现行官方标签逐项复核。", "en": "Not automatically. The archive locates a source; each point needs verification against the target market’s current official label." } }, { "question": { "zh": "为什么这里不展示价格或原研/仿制结论？", "en": "Why are price and originator/generic conclusions not shown?" }, "answer": { "zh": "这些结论需要产品、剂型、规格、包装、市场、日期和原始记录分别齐全并经人工审核；单一标签文件不足以支持。", "en": "Those conclusions require separately complete and human-reviewed product, dosage-form, strength, pack, market, date and primary-record fields; one label file is insufficient." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "how-to-read-a-drug-label", "regulatory-sources-first" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/symbicort/", "en": "https://origindrug.com/en/drugs/symbicort/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "trelegy-ellipta", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-19", "status": "published_traceable_archive" }, "names": { "brand": "Trelegy Ellipta", "generic": "糠酸氟替卡松/乌美溴铵/维兰特罗", "aliases": [ "TRELEGY ELLIPTA", "fluticasone furoate umeclidinium and vilanterol", "fluticasone furoate/umeclidinium/vilanterol", "糠酸氟替卡松/乌美溴铵/维兰特罗", "氟替卡松呋喃酸酯/乌美溴铵/维兰特罗" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "呼吸系统", "sourceArchiveMarket": "美国当前 TRELEGY ELLIPTA 糠酸氟替卡松/乌美溴铵/维兰特罗公开标签（DailyMed SPL v14：2025-11-19 发布）", "dosageFormClass": "三成分干粉吸入器：100/62.5/25 或 200/62.5/25 mcg/次吸入（当前美国标签所列）", "dosageFormClassCode": "inhaled_device", "route": "经口吸入", "routeCode": "inhalation", "historicalApprovalEntry": "2017（当前美国标签所列 Initial U.S. Approval）", "archiveSponsorText": "GlaxoSmithKline LLC / DailyMed（NLM）当前公开标签档案" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [ "VENTOLIN", "albuterol", "salbutamol", "rescue inhaler", "ANORO ELLIPTA", "INCRUSE ELLIPTA", "BREO ELLIPTA", "fluticasone furoate and vilanterol", "umeclidinium and vilanterol", "急救吸入", "TRELEGY HFA", "hfa", "metered-dose inhaler", "nebulizer", "handihaler", "diskus" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-trelegy-ellipta-100-62-5-25-30-inhalations-ndc-0173-0887-10", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v14（2025-11-19 发布）", "en": "DailyMed SPL v14 published 2025-11-19" }, "dosageForm": { "zh": "三成分干粉吸入器", "en": "three-ingredient dry-powder inhaler" }, "route": { "zh": "经口吸入", "en": "oral inhalation" }, "routeCodes": [ "oral_inhalation" ], "productCode": "NDC 0173-0887-10", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_inhalation", "primaryDisplay": { "zh": "100/62.5/25 mcg／标签每次吸入；1 个 ELLIPTA 吸入器（30 次标签吸入；60 个泡罩）", "en": "100/62.5/25 mcg per labelled inhalation; one ELLIPTA inhaler (30 labelled inhalations; 60 blisters)" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=b5a81d5a-4648-4c7a-951d-33c014a63c7e&name=trelegy-ellipta-spl-graphic-26.jpg", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "糠酸氟替卡松", "en": "fluticasone furoate" }, "value": 100, "unit": "mcg", "basisCode": "per_inhalation", "basisLabel": { "zh": "标签每次吸入的成分标示；不是个人使用指令", "en": "labelled ingredient amount per inhalation; not an individual's use instruction" } }, { "ingredient": { "zh": "乌美溴铵", "en": "umeclidinium" }, "value": 62.5, "unit": "mcg", "basisCode": "per_inhalation", "basisLabel": { "zh": "标签每次吸入的成分标示；不是个人使用指令", "en": "labelled ingredient amount per inhalation; not an individual's use instruction" } }, { "ingredient": { "zh": "维兰特罗", "en": "vilanterol" }, "value": 25, "unit": "mcg", "basisCode": "per_inhalation", "basisLabel": { "zh": "标签每次吸入的成分标示；不是个人使用指令", "en": "labelled ingredient amount per inhalation; not an individual's use instruction" } } ], "concentration": null, "container": { "typeCode": "dry_powder_inhaler", "typeLabel": { "zh": "ELLIPTA 干粉吸入器", "en": "ELLIPTA dry-powder inhaler" }, "fill": null, "countPerPackage": 1, "countUnit": { "zh": "吸入器/盒", "en": "inhaler per carton" }, "unitsPerContainer": { "count": 30, "unit": { "zh": "次标签吸入", "en": "labelled inhalations" } } }, "deliveryDevice": { "typeCode": "ellipta_dry_powder_inhaler", "name": { "zh": "ELLIPTA 吸入器", "en": "ELLIPTA inhaler" } }, "compatibleReusableDevice": null, "listingStatus": null, "package": { "count": 1, "unit": { "zh": "吸入器/盒（30 次标签吸入；60 个泡罩）", "en": "inhaler per carton (30 labelled inhalations; 60 blisters)" } }, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_2a8f04a161167cfd", "label": "DailyMed（NLM）：TRELEGY ELLIPTA 糠酸氟替卡松/乌美溴铵/维兰特罗当前美国公开标签（GSK；SPL v14）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=b5a81d5a-4648-4c7a-951d-33c014a63c7e&version=14", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-trelegy-ellipta-200-62-5-25-30-inhalations-ndc-0173-0893-10", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v14（2025-11-19 发布）", "en": "DailyMed SPL v14 published 2025-11-19" }, "dosageForm": { "zh": "三成分干粉吸入器", "en": "three-ingredient dry-powder inhaler" }, "route": { "zh": "经口吸入", "en": "oral inhalation" }, "routeCodes": [ "oral_inhalation" ], "productCode": "NDC 0173-0893-10", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_inhalation", "primaryDisplay": { "zh": "200/62.5/25 mcg／标签每次吸入；1 个 ELLIPTA 吸入器（30 次标签吸入；60 个泡罩）", "en": "200/62.5/25 mcg per labelled inhalation; one ELLIPTA inhaler (30 labelled inhalations; 60 blisters)" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=b5a81d5a-4648-4c7a-951d-33c014a63c7e&name=trelegy-ellipta-spl-graphic-27.jpg", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "糠酸氟替卡松", "en": "fluticasone furoate" }, "value": 200, "unit": "mcg", "basisCode": "per_inhalation", "basisLabel": { "zh": "标签每次吸入的成分标示；不是个人使用指令", "en": "labelled ingredient amount per inhalation; not an individual's use instruction" } }, { "ingredient": { "zh": "乌美溴铵", "en": "umeclidinium" }, "value": 62.5, "unit": "mcg", "basisCode": "per_inhalation", "basisLabel": { "zh": "标签每次吸入的成分标示；不是个人使用指令", "en": "labelled ingredient amount per inhalation; not an individual's use instruction" } }, { "ingredient": { "zh": "维兰特罗", "en": "vilanterol" }, "value": 25, "unit": "mcg", "basisCode": "per_inhalation", "basisLabel": { "zh": "标签每次吸入的成分标示；不是个人使用指令", "en": "labelled ingredient amount per inhalation; not an individual's use instruction" } } ], "concentration": null, "container": { "typeCode": "dry_powder_inhaler", "typeLabel": { "zh": "ELLIPTA 干粉吸入器", "en": "ELLIPTA dry-powder inhaler" }, "fill": null, "countPerPackage": 1, "countUnit": { "zh": "吸入器/盒", "en": "inhaler per carton" }, "unitsPerContainer": { "count": 30, "unit": { "zh": "次标签吸入", "en": "labelled inhalations" } } }, "deliveryDevice": { "typeCode": "ellipta_dry_powder_inhaler", "name": { "zh": "ELLIPTA 吸入器", "en": "ELLIPTA inhaler" } }, "compatibleReusableDevice": null, "listingStatus": null, "package": { "count": 1, "unit": { "zh": "吸入器/盒（30 次标签吸入；60 个泡罩）", "en": "inhaler per carton (30 labelled inhalations; 60 blisters)" } }, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_2a8f04a161167cfd", "label": "DailyMed（NLM）：TRELEGY ELLIPTA 糠酸氟替卡松/乌美溴铵/维兰特罗当前美国公开标签（GSK；SPL v14）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=b5a81d5a-4648-4c7a-951d-33c014a63c7e&version=14", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": null, "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=b5a81d5a-4648-4c7a-951d-33c014a63c7e&name=trelegy-ellipta-spl-graphic-26.jpg", "alt": "TRELEGY ELLIPTA 在美国 DailyMed 当前标签中的 100/62.5/25 mcg、NDC 0173-0887-10、30 次吸入纸盒面板", "archiveMarket": "美国", "labelVersion": "DailyMed SPL v14（2025-11-19 发布）", "presentation": "TRELEGY ELLIPTA 三成分干粉吸入器：100/62.5/25 mcg/次吸入；NDC 0173-0887-10；30 次吸入（60 个泡罩）纸盒面板。", "notice": "此图只对应美国当前标签中的 TRELEGY ELLIPTA 100/62.5/25 mcg、NDC 0173-0887-10、30 次吸入纸盒。它不代表 200/62.5/25 mcg、14 次机构包装、其他 ELLIPTA 产品、其他吸入器或其他市场；不用于鉴定真伪，也不生成个人吸入步骤、次数、补用、转换或联合方案。", "source": { "id": "src_2a8f04a161167cfd", "label": "DailyMed（NLM）：TRELEGY ELLIPTA 糠酸氟替卡松/乌美溴铵/维兰特罗当前美国公开标签（GSK；SPL v14）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=b5a81d5a-4648-4c7a-951d-33c014a63c7e&version=14", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "TRELEGY ELLIPTA 说明书放大阅读：100/62.5/25 是三种成分和一个装置的身份", "en": "TRELEGY ELLIPTA label reading: 100/62.5/25 identifies three ingredients and one device" }, "summary": { "zh": "本模块以当前美国公开标签为阅读入口，帮助核对 TRELEGY ELLIPTA、三种成分、完整三数字、干粉吸入装置、NDC 与标签版本。它不决定个人吸入次数、装置操作、是否与另一吸入药同用、如何加减或急性症状时应自行如何处理。", "en": "This module uses the current U.S. public label to check TRELEGY ELLIPTA, all three ingredients, the complete three-number marking, dry-powder inhaler, NDC and label version. It does not decide individual inhalation use, device operation, co-use with another inhaler, adjustment or self-management of an acute symptom." }, "checks": [ { "zh": "100/62.5/25 与 200/62.5/25 mcg 是每次吸入中三种成分的完整标示，不是可由网页拆成、相加或换成个人吸入次数的公式。还要同时核对装置、NDC、包装次数、目标市场和标签版本。", "en": "100/62.5/25 and 200/62.5/25 mcg are complete three-ingredient markings per inhalation, not a formula a webpage can split, add or convert into an individual's inhalation use. Also check the device, NDC, pack count, target market and label version together." }, { "zh": "TRELEGY ELLIPTA 与 VENTOLIN HFA、ANORO ELLIPTA、INCRUSE ELLIPTA、BREO ELLIPTA 或其他吸入产品并不因都出现“吸入”“ELLIPTA”或一项共同成分而可自行叠加、轮换、替代或共用装置。", "en": "TRELEGY ELLIPTA is not self-combinable, alternatable, substitutable or device-shareable with VENTOLIN HFA, ANORO ELLIPTA, INCRUSE ELLIPTA, BREO ELLIPTA or another inhaler merely because labels mention inhalation, ELLIPTA or one shared ingredient." }, { "zh": "当前标签明确其不用于缓解急性支气管痉挛。突发或加重的呼吸困难、胸痛、发绀、说话困难、昏厥或其他急性担忧，应依当地紧急医疗计划和医生指示处理，而不是根据本页自行加用、补用或改用吸入产品。", "en": "The current label states it is not indicated for relief of acute bronchospasm. Sudden or worsening breathing difficulty, chest pain, cyanosis, trouble speaking, fainting or another acute concern needs the local urgent-care plan and clinician guidance, not self-added, make-up or changed inhaler use from this page." }, { "zh": "吸入装置的开封、储存、清洁、吸入动作和剩余剂量计数都应回到实际产品的患者说明和药师/开方团队演示；网页只帮助定位准确标签，不能替代装置教学。", "en": "Device opening, storage, cleaning, inhalation technique and remaining-dose counting must return to the patient instructions for the actual product and demonstration by a pharmacist/prescribing team; this page only helps locate the exact label and cannot replace device teaching." } ], "source": { "id": "src_2a8f04a161167cfd", "label": "DailyMed（NLM）：TRELEGY ELLIPTA 糠酸氟替卡松/乌美溴铵/维兰特罗当前美国公开标签（GSK；SPL v14）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=b5a81d5a-4648-4c7a-951d-33c014a63c7e&version=14", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "三种吸入成分怎样协同出现：ICS、抗胆碱能与长效 β₂ 激动剂路径", "en": "How three inhaled ingredients appear together: ICS, anticholinergic and long-acting beta2-agonist pathways" }, "summary": { "zh": "当前标签将 TRELEGY ELLIPTA 描述为吸入性糖皮质激素糠酸氟替卡松、抗胆碱能成分乌美溴铵和长效 β₂ 肾上腺素能激动剂维兰特罗的固定复方。机制帮助理解为什么完整药单与装置核对重要，不预测个人肺功能、急性症状、疗效、吸入次数或能否换药。", "en": "The current label describes TRELEGY ELLIPTA as a fixed combination of the inhaled corticosteroid fluticasone furoate, the anticholinergic umeclidinium and the long-acting beta2-adrenergic agonist vilanterol. Mechanism helps explain why complete-list and device review matters; it does not predict individual lung function, acute symptoms, benefit, inhalation use or whether a switch is suitable." }, "checks": [ { "zh": "三条作用路径不表示可以自行增加其他含 LABA、抗胆碱能药或吸入性糖皮质激素的产品。任何新增、停用、轮换或替代都需要让药师或医生逐项核对完整药单与准确装置。", "en": "Three pathways do not mean another LABA-, anticholinergic- or inhaled-corticosteroid-containing product can be self-added. Any addition, stopping, alternation or substitution needs a pharmacist or clinician to review the complete list and exact devices item by item." }, { "zh": "“长期维持”“吸入”“支气管扩张”或共同的装置家族名都不能把本品变成急性症状的通用处理答案，也不能让一个装置的操作方法自动适用于另一装置。", "en": "‘Maintenance’, ‘inhalation’, ‘bronchodilation’ or a shared device-family name cannot turn this product into a general acute-symptom answer or make one device's operation automatically apply to another." }, { "zh": "机制说明不能处理眼痛/视力改变、排尿困难、心悸、过敏、感染征象或任何严重呼吸症状。出现这些担忧时应使用当地医疗支持，不从机制文字自行调整。", "en": "A mechanism explanation cannot manage eye pain/vision change, urinary difficulty, palpitations, allergy, infection signs or any severe respiratory symptom. With these concerns, use local medical support rather than self-adjusting from mechanism text." } ], "source": { "id": "src_2a8f04a161167cfd", "label": "DailyMed（NLM）：TRELEGY ELLIPTA 糠酸氟替卡松/乌美溴铵/维兰特罗当前美国公开标签（Clinical Pharmacology；GSK；SPL v14）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=b5a81d5a-4648-4c7a-951d-33c014a63c7e&version=14", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "Trelegy Ellipta", "generic": "糠酸氟替卡松/乌美溴铵/维兰特罗", "dosageFormClass": "三成分干粉吸入器：100/62.5/25 或 200/62.5/25 mcg/次吸入（当前美国标签所列）" }, "labelSource": { "id": "src_2a8f04a161167cfd", "label": "DailyMed（NLM）：TRELEGY ELLIPTA 糠酸氟替卡松/乌美溴铵/维兰特罗当前美国公开标签（GSK；SPL v14）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=b5a81d5a-4648-4c7a-951d-33c014a63c7e&version=14", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "productRoutes": [ { "source": { "id": "src_2a8f04a161167cfd", "label": "DailyMed（NLM）：TRELEGY ELLIPTA 糠酸氟替卡松/乌美溴铵/维兰特罗当前美国公开标签（GSK；SPL v14）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=b5a81d5a-4648-4c7a-951d-33c014a63c7e&version=14", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "DailyMed 当前 TRELEGY ELLIPTA 标签将其列为含糠酸氟替卡松、乌美溴铵和维兰特罗的三成分干粉吸入器。本页帮助核对完整品牌、全部三种成分、完整三数字、吸入装置、包装、标签版本和目标市场；不把任何数字变成个人吸入次数、使用步骤、加减量、补用、转换或联合方案。", "history": "当前美国标签列示 Initial U.S. Approval: 2017，SPL v14 于 2025-11-19 公开。其三种成分与 VENTOLIN HFA、ANORO ELLIPTA、INCRUSE ELLIPTA、BREO ELLIPTA 等产品的成分数量或用途线索不同；名称相近或均为吸入产品不能证明可自行替代、加用或把本品作为急性症状缓解药。", "sourceDocuments": [ { "id": "src_2a8f04a161167cfd", "label": "DailyMed（NLM）：TRELEGY ELLIPTA 糠酸氟替卡松/乌美溴铵/维兰特罗当前美国公开标签（GSK；SPL v14）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=b5a81d5a-4648-4c7a-951d-33c014a63c7e&version=14", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } ], "applicationNumber": "NDA 209482", "approvalTimeline": [ { "date": "2017-09-18", "title": { "zh": "NDA 209482 原始申请批准", "en": "NDA 209482 original application approval" }, "detail": { "zh": "FDA Drugs@FDA 公开记录将 TRELEGY ELLIPTA 的原始申请（ORIG 1）标为 2017-09-18 获批；该美国监管节点不建立其他市场的批准、供应或个人适用性。", "en": "The FDA Drugs@FDA public record lists TRELEGY ELLIPTA original application (ORIG 1) as approved on 18 Sep 2017. This U.S. regulatory node does not establish approval, supply or individual suitability in another market." }, "source": { "id": "src_e7b5a9ecc4741628", "label": "FDA: TRELEGY ELLIPTA NDA 209482 original approval letter (2017-09-18)", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/209482Orig1s000ltr.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "approval_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, { "date": "2017", "title": { "zh": "当前标签所列美国初始批准年份", "en": "Initial U.S. approval year listed in the current label" }, "detail": { "zh": "当前 TRELEGY ELLIPTA 标签列示 Initial U.S. Approval: 2017；该年份不自动说明其他市场的产品状态。", "en": "The current TRELEGY ELLIPTA label lists Initial U.S. Approval: 2017; it does not establish product status in another market." }, "source": { "id": "src_2a8f04a161167cfd", "label": "DailyMed: current TRELEGY ELLIPTA public label, SPL v14", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=b5a81d5a-4648-4c7a-951d-33c014a63c7e&version=14", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, { "date": "2025-11-19", "title": { "zh": "DailyMed 公开当前 SPL v14", "en": "Current SPL v14 published on DailyMed" }, "detail": { "zh": "DailyMed 将当前 v14 的 Published Date 列为 2025-11-19；该日期不代表个人使用、可售或供应状态。", "en": "DailyMed lists 19 Nov 2025 as the current v14 Published Date; it does not represent individual use, availability or supply status." }, "source": { "id": "src_2a8f04a161167cfd", "label": "DailyMed: current TRELEGY ELLIPTA public label, SPL v14", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=b5a81d5a-4648-4c7a-951d-33c014a63c7e&version=14", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "已链接当前三成分标签与一个精确纸盒面板", "en": "Current three-ingredient label and one exact carton panel linked" }, "detail": { "zh": "展示图只对应 100/62.5/25 mcg、NDC 0173-0887-10、30 次吸入（60 个泡罩）；不据此建立实际在售、库存、个人操作或其他规格状态。", "en": "The image corresponds only to 100/62.5/25 mcg, NDC 0173-0887-10 and 30 inhalations (60 blisters); it does not establish actual marketing, stock, individual device operation or another-strength status." } }, { "market": { "zh": "中国大陆、欧盟、日本及其他市场", "en": "Mainland China, EU, Japan and other markets" }, "status": { "zh": "待逐项建立市场记录", "en": "Market record not established" }, "detail": { "zh": "不从美国标签推定当地商品名、批准、装置、供应、原研关系或可替代性。", "en": "No local trade name, approval, device, supply, originator relationship or interchangeability is inferred from the U.S. label." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "100/62.5/25 mcg 是不是可以只看其中一个数字？", "en": "Can 100/62.5/25 mcg be read as just one of its three numbers?" }, "answer": { "zh": "不能。它是这一准确三成分吸入产品每次吸入的完整身份标示。页面不把它变成个人吸入次数、装置操作、调整或与其他吸入产品的换算。", "en": "No. It is the complete per-inhalation identity marking for this exact three-ingredient inhaler. The page does not turn it into individual inhalation use, device operation, adjustment or conversion to another inhaler." } }, { "question": { "zh": "TRELEGY ELLIPTA 能否和其他 ELLIPTA 或急救吸入药自行互换？", "en": "Can TRELEGY ELLIPTA be self-switched with another ELLIPTA or rescue inhaler?" }, "answer": { "zh": "不能。相近装置名、共同成分或都用于呼吸系统并不建立可自行互换关系。标签也明确本品不用于缓解急性支气管痉挛；请带实际装置和完整药单咨询药师或开方团队。", "en": "No. Similar device names, shared ingredients or respiratory use do not establish self-interchangeability. The label also states it is not for relief of acute bronchospasm; take the actual devices and complete medicine list to a pharmacist or prescribing team." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "dosage-forms-are-part-of-medicine-identity", "how-to-read-a-drug-label" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/trelegy-ellipta/", "en": "https://origindrug.com/en/drugs/trelegy-ellipta/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "allegra-allergy", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-24", "status": "published_traceable_archive" }, "names": { "brand": "ALLEGRA ALLERGY", "generic": "盐酸非索非那定", "aliases": [ "fexofenadine", "fexofenadine hydrochloride", "盐酸非索非那定" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "呼吸系统", "sourceArchiveMarket": "美国 OTC 公开标签档案（当前页面精确对应 180 mg、30 片塑料瓶装纸盒，NDC 41167-4120-3）", "dosageFormClass": "口服薄膜衣片（本档案限定为盐酸非索非那定 180 mg 片）", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "未在本页推定（应按目标市场官方记录核验）", "archiveSponsorText": "DailyMed（NLM）公开标签档案；Chattem, Inc." }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [ "ALLEGRA ALLERGY 180 mg Tablets" ], "excludedProductCues": [ "ALLEGRA-D", "ALLEGRA D", "fexofenadine pseudoephedrine", "ALLEGRA 60 mg", "ALLEGRA oral suspension" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-allegra-allergy-fexofenadine-hcl-tablet-180mg-30ct-ndc-41167-4120-3", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v64，2026-04-14 发布", "en": "DailyMed SPL v64, published 14 Apr 2026" }, "dosageForm": { "zh": "ALLEGRA ALLERGY 盐酸非索非那定薄膜衣口服片", "en": "ALLEGRA ALLERGY fexofenadine hydrochloride film-coated oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 41167-4120-3", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片盐酸非索非那定 180 mg；30 片塑料瓶装纸盒", "en": "Fexofenadine hydrochloride 180 mg per tablet; 30-tablet plastic-bottle carton" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=allegra-allergy-02.jpg&setid=81c1dcbb-28b3-4ad5-9f3d-9ccc16ddd173", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "盐酸非索非那定", "en": "fexofenadine hydrochloride" }, "value": 180, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、联用或换药规则", "en": "labelled amount per tablet; not an individual's tablet count, combination or switching rule" } } ], "concentration": null, "container": { "typeCode": "bottle_carton", "typeLabel": { "zh": "30 片塑料瓶装纸盒", "en": "30-tablet plastic-bottle carton" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "片/瓶装纸盒", "en": "tablets per bottle carton" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-24", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 30, "unit": { "zh": "片/瓶装纸盒", "en": "tablets per bottle carton" } }, "physicalClues": { "color": { "zh": "橙桃色", "en": "orange (peach)" }, "shape": { "zh": "椭圆形薄膜衣片", "en": "oval film-coated tablet" }, "imprint": "018 / E", "scoreStatus": "not_scored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_e1b9086ac4bd137e", "label": "DailyMed（NLM）：ALLEGRA ALLERGY 盐酸非索非那定当前美国 OTC 公开标签（Chattem；SPL v64，2026-04-14 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=81c1dcbb-28b3-4ad5-9f3d-9ccc16ddd173", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-allegra-allergy-fexofenadine-hcl-tablet-180mg-30ct-ndc-41167-4120-3", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=allegra-allergy-02.jpg&setid=81c1dcbb-28b3-4ad5-9f3d-9ccc16ddd173", "alt": "ALLEGRA ALLERGY 盐酸非索非那定在美国 DailyMed Chattem 公开标签中的 180 mg、NDC 41167-4120-3、30 片塑料瓶装纸盒展示面", "archiveMarket": "美国", "labelVersion": "DailyMed SPL v64（2026-04-14 发布）", "presentation": "ALLEGRA ALLERGY 盐酸非索非那定薄膜衣口服片：每片 180 mg，NDC 41167-4120-3，30 片塑料瓶装纸盒展示面。", "notice": "此图只对应美国 DailyMed 当前标签中的 ALLEGRA ALLERGY、盐酸非索非那定 180 mg、NDC 41167-4120-3 与 30 片塑料瓶装纸盒。它只帮助核对品牌、通用名、每片标示量、片剂、包装数量与来源；不用于鉴定真伪，也不证明 60 mg 片、ALLEGRA-D、其他包装、其他市场、当前可得性、原研身份、可替代性，或任何个人的片数、联用、开始、停用或换药方案。", "source": { "id": "src_e1b9086ac4bd137e", "label": "DailyMed（NLM）：ALLEGRA ALLERGY 盐酸非索非那定当前美国 OTC 公开标签（Chattem；SPL v64，2026-04-14 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=81c1dcbb-28b3-4ad5-9f3d-9ccc16ddd173", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "ALLEGRA ALLERGY 说明书放大阅读：180 mg、24 小时和实际包装须一起核对", "en": "ALLEGRA ALLERGY label reading: read 180 mg, 24-hour wording and the actual pack together" }, "summary": { "zh": "本模块以美国 DailyMed 公开标签为阅读入口，帮助核对 ALLEGRA ALLERGY、盐酸非索非那定、每片 180 mg、口服薄膜衣片、30 片包装和目标市场。它不提供个人片数、联用、停用或换药指令。", "en": "This module uses the U.S. DailyMed public label to check ALLEGRA ALLERGY, fexofenadine hydrochloride, 180 mg per tablet, film-coated oral-tablet form, the 30-tablet pack and target market. It does not provide individual tablet-count, combination, stopping or switching instructions." }, "checks": [ { "zh": "先将 ALLEGRA ALLERGY、盐酸非索非那定、每片 180 mg、口服片剂、30 片包装和目标市场一起核对。180 mg 是这一个准确片剂的标签标示量，不是网页给任何人计算片数的答案。", "en": "Check ALLEGRA ALLERGY, fexofenadine hydrochloride, 180 mg per tablet, oral-tablet form, 30-tablet pack and target market together. 180 mg is the label strength for this exact tablet, not a web answer to anyone's tablet count." }, { "zh": "同一美国标签同时列有 60 mg 与 180 mg 片剂。不要因为都叫 ALLEGRA、都写抗组胺药或都写“小时”，就按片数、经验或毫克数自行换算、叠加或换成另一种产品；也不要把 ALLEGRA-D 等复方当作同一产品。", "en": "The same U.S. label also lists 60 mg and 180 mg tablets. A shared ALLEGRA name, antihistamine wording or hour wording does not make products self-convertible, combinable or interchangeable by tablet count, experience or milligrams; ALLEGRA-D combinations are not the same product." }, { "zh": "该标签提示肾病、妊娠或哺乳时先咨询专业人员；并提示不要与含铝或镁的抗酸药同时服用，也不要与果汁同服。出现这些情况、存在多种过敏/感冒产品或不确定怎样使用时，应带完整药单和实际包装请药师或医生核对，而不是自行调整。", "en": "The label tells readers with kidney disease, pregnancy or breastfeeding to ask a professional first; it also warns against taking it at the same time as aluminum- or magnesium-containing antacids and against taking it with fruit juices. With these circumstances, multiple allergy/cold products or uncertainty about use, take the full medicine list and actual pack to a pharmacist or clinician rather than self-adjusting." }, { "zh": "包装图、颜色、刻印或品牌名只能帮助定位来源，不能鉴定真伪、证明当前批准或决定个人是否适用。疑似过敏反应、过量、症状加重或不确定下一步时，应使用当地医疗渠道。", "en": "A package image, colour, imprint or brand name can only help locate a source; it cannot authenticate a product, establish current approval or decide individual suitability. With a suspected reaction, overdose, worsening symptoms or uncertainty about the next step, use local medical channels." } ], "source": { "id": "src_e1b9086ac4bd137e", "label": "DailyMed（NLM）：ALLEGRA ALLERGY 盐酸非索非那定当前美国 OTC 公开标签（Chattem；SPL v64，2026-04-14 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=81c1dcbb-28b3-4ad5-9f3d-9ccc16ddd173", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "盐酸非索非那定怎样被标签归类：抗组胺药不等于可自行叠加", "en": "How fexofenadine hydrochloride is classified on the label: an antihistamine is not automatically combinable" }, "summary": { "zh": "美国 DailyMed 标签把盐酸非索非那定标为抗组胺药。这个类别帮助读者找到标签的用途、警示和准确产品身份；它不决定某个人是否适用，或能否与另一种抗过敏、感冒、睡眠或镇静产品一起使用。", "en": "The U.S. DailyMed label classifies fexofenadine hydrochloride as an antihistamine. This helps readers find the label's use, warning and exact-product identity; it does not decide individual suitability or whether another allergy, cold, sleep or sedating product can be used with it." }, "checks": [ { "zh": "“抗组胺药”是标签类别线索，不是症状诊断或自我分诊工具。持续、加重、呼吸困难或不明原因的症状应由当地专业渠道判断。", "en": "“Antihistamine” is a label-class clue, not a symptom-diagnosis or self-triage tool. Persistent, worsening, breathing-related or unexplained symptoms need local professional assessment." }, { "zh": "同属抗组胺药不表示盐酸非索非那定可以与氯雷他定、西替利嗪、复方感冒药或另一种抗过敏产品自行叠加、轮换、替代或按毫克数换算。", "en": "A shared antihistamine class does not make fexofenadine hydrochloride self-combinable, alternatable, substitutable or convertible by milligrams with loratadine, cetirizine, a combination cold medicine or another allergy product." }, { "zh": "标签中特定的果汁与抗酸药警示说明为什么完整药单、饮食/非处方产品和准确包装都要一起核对；它不是网页把每个人划为“安全”或“不安全”的规则。", "en": "The label's specific fruit-juice and antacid warnings show why the complete medicine list, food/OTC products and exact pack must be reviewed together; they are not a web rule that sorts every person into “safe” or “unsafe.”" } ], "source": { "id": "src_e1b9086ac4bd137e", "label": "DailyMed（NLM）：ALLEGRA ALLERGY 盐酸非索非那定当前美国 OTC 公开标签（Chattem；SPL v64，2026-04-14 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=81c1dcbb-28b3-4ad5-9f3d-9ccc16ddd173", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "ALLEGRA ALLERGY", "generic": "盐酸非索非那定", "dosageFormClass": "口服薄膜衣片（本档案限定为盐酸非索非那定 180 mg 片）" }, "labelSource": { "id": "src_e1b9086ac4bd137e", "label": "DailyMed（NLM）：ALLEGRA ALLERGY 盐酸非索非那定当前美国 OTC 公开标签（Chattem；SPL v64，2026-04-14 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=81c1dcbb-28b3-4ad5-9f3d-9ccc16ddd173", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "productRoutes": [ { "source": { "id": "src_e1b9086ac4bd137e", "label": "DailyMed（NLM）：ALLEGRA ALLERGY 盐酸非索非那定当前美国 OTC 公开标签（Chattem；SPL v64，2026-04-14 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=81c1dcbb-28b3-4ad5-9f3d-9ccc16ddd173", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "DailyMed 的 ALLEGRA ALLERGY（fexofenadine hydrochloride）美国 OTC 公开标签将本档案所列产品标示为每片 180 mg 的口服抗组胺薄膜衣片。页面帮助阅读品牌、通用名、每片强度、准确包装和美国标签范围；不据此推定中国大陆或其他市场的批准、包装、持有人、原研关系、供应或可售资格。", "history": "同一标签档案中还可见 60 mg 片与不同包装数量。相同品牌、相同“抗过敏”文字或相似毫克数，均不足以把不同强度、剂型、复方或不同市场产品当作可自行换算、叠加或替代的产品。", "sourceDocuments": [ { "id": "src_e1b9086ac4bd137e", "label": "DailyMed（NLM）：ALLEGRA ALLERGY 盐酸非索非那定当前美国 OTC 公开标签（Chattem；SPL v64，2026-04-14 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=81c1dcbb-28b3-4ad5-9f3d-9ccc16ddd173", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_5ed30b676fbb9773", "label": "FDA Drugs@FDA 官方检索入口", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_lookup_entry", "documentKind": "regulatory_lookup", "market": "US", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } ], "applicationNumber": "DailyMed U.S. OTC label record", "approvalTimeline": [ { "date": "2026-04", "title": { "zh": "DailyMed 公开标签版本", "en": "DailyMed public label version" }, "detail": { "zh": "本页链接 2026-04 的 DailyMed 美国 OTC 公开标签作为可复核阅读入口。它标识该具体公开标签，不推定初始批准年份、NDA 编号、当前供应、持有人或其他市场状态。", "en": "This page links the 2026-04 DailyMed U.S. OTC public label as a traceable reading entry point. It identifies that specific public label and does not assert an original-approval year, NDA number, current availability, holder or another-market status." }, "source": { "id": "src_e1b9086ac4bd137e", "label": "DailyMed: ALLEGRA ALLERGY fexofenadine hydrochloride current public OTC label", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=81c1dcbb-28b3-4ad5-9f3d-9ccc16ddd173", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "已链接 OTC 公开标签", "en": "OTC public label linked" }, "detail": { "zh": "仅对应本页所列 DailyMed OTC 文件。", "en": "Only the DailyMed OTC document listed on this page is linked." } }, { "market": { "zh": "中国大陆、欧盟、日本", "en": "Mainland China, EU, Japan" }, "status": { "zh": "待逐项建立市场记录", "en": "Market record not established" }, "detail": { "zh": "不从美国 OTC 标签推定当地批准、持有人、规格、供应或可售资格。", "en": "No local approval, holder, strength, supply or sale-eligibility conclusion is inferred from the U.S. OTC label." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "美国 OTC 标签能代表其他市场或个人用法吗？", "en": "Does a U.S. OTC label represent another market or personal use?" }, "answer": { "zh": "不能。它仅是这一具体美国公开标签的阅读入口；目标市场的现行文件和个人情况必须分别由专业人员核对。", "en": "No. It is only a reading entry point for this specific U.S. public label; the current target-market document and individual circumstances need separate professional review." } }, { "question": { "zh": "为什么不把 OTC 档案写成原始批准或原研结论？", "en": "Why does the OTC archive not state original approval or originator conclusions?" }, "answer": { "zh": "标签记录不足以证明这些结论。它们需要可追溯的产品、剂型、市场、时间和一手监管记录，并经人工审核。", "en": "A label record is insufficient to prove those conclusions. They require traceable product, dosage-form, market, date and primary regulatory records with human review." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "how-to-read-a-drug-label", "regulatory-sources-first" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/allegra-allergy/", "en": "https://origindrug.com/en/drugs/allegra-allergy/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "imodium-a-d", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-24", "status": "published_traceable_archive" }, "names": { "brand": "IMODIUM A-D", "generic": "盐酸洛哌丁胺", "aliases": [ "imodium", "loperamide", "loperamide hydrochloride", "盐酸洛哌丁胺" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "消化系统", "sourceArchiveMarket": "美国 OTC 公开标签档案（当前页面精确对应 2 mg、12 片〔2 板×6 片〕纸盒，NDC 50580-317-06）", "dosageFormClass": "口服薄膜衣片（本档案限定为盐酸洛哌丁胺 2 mg 片）", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "未在本页推定（应按目标市场官方记录核验）", "archiveSponsorText": "DailyMed（NLM）公开标签档案；Kenvue Brands LLC" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [ "IMODIUM A-D 2 mg Caplets" ], "excludedProductCues": [ "IMODIUM Multi-Symptom Relief", "loperamide simethicone", "IMODIUM oral solution", "IMODIUM liquid" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-imodium-a-d-loperamide-hcl-film-coated-tablet-2mg-12ct-ndc-50580-317-06", "marketCode": "US", "labelVersion": { "zh": "DailyMed 标签 2025-09-23 更新", "en": "DailyMed label updated 23 Sep 2025" }, "dosageForm": { "zh": "IMODIUM A-D 盐酸洛哌丁胺薄膜衣口服片", "en": "IMODIUM A-D loperamide hydrochloride film-coated oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 50580-317-06", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片盐酸洛哌丁胺 2 mg；12 片（2 板×6 片）纸盒", "en": "Loperamide hydrochloride 2 mg per caplet; 12-caplet carton (2 blisters of 6)" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=imodium-01.jpg&setid=01da76d0-1979-4c45-9d39-c72ae4e4ffe2&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "盐酸洛哌丁胺", "en": "loperamide hydrochloride" }, "value": 2, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、联用或换药规则", "en": "labelled amount per caplet; not an individual's tablet count, combination or switching rule" } } ], "concentration": null, "container": { "typeCode": "blister_carton", "typeLabel": { "zh": "2 板×6 片泡罩装纸盒", "en": "carton with 2 blister packs of 6 caplets" }, "fill": null, "countPerPackage": 12, "countUnit": { "zh": "片/纸盒", "en": "caplets per carton" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-24", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 12, "unit": { "zh": "片/纸盒", "en": "caplets per carton" } }, "physicalClues": { "color": { "zh": "白色", "en": "white" }, "shape": { "zh": "椭圆形薄膜衣片（标签称 capsule-shaped）", "en": "oval film-coated caplet (label calls it capsule-shaped)" }, "imprint": "IMO / 2 / MG", "scoreStatus": "scored_status_not_a_split_instruction", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_c020c855fd353d39", "label": "DailyMed（NLM）：IMODIUM A-D 盐酸洛哌丁胺 2 mg 薄膜衣片当前美国 OTC 公开标签（Kenvue Brands；2025-09-23 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=01da76d0-1979-4c45-9d39-c72ae4e4ffe2", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-imodium-a-d-loperamide-hcl-film-coated-tablet-2mg-12ct-ndc-50580-317-06", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=imodium-01.jpg&setid=01da76d0-1979-4c45-9d39-c72ae4e4ffe2&type=img", "alt": "IMODIUM A-D 盐酸洛哌丁胺在美国 DailyMed Kenvue 公开标签中的 2 mg、NDC 50580-317-06、12 片（2 板×6 片）纸盒展示面", "archiveMarket": "美国", "labelVersion": "DailyMed 标签（2025-09-23 更新）", "presentation": "IMODIUM A-D 盐酸洛哌丁胺薄膜衣口服片：每片 2 mg，NDC 50580-317-06，12 片（2 板×6 片）泡罩装纸盒展示面。", "notice": "此图只对应美国 DailyMed 当前标签中的 IMODIUM A-D、盐酸洛哌丁胺 2 mg、NDC 50580-317-06 与 12 片（2 板×6 片）泡罩装纸盒。它只帮助核对品牌、通用名、每片标示量、片剂、包装数量与来源；不用于鉴定真伪，也不证明复方 IMODIUM、液体、其他包装、其他市场、当前可得性、原研身份、可替代性，或任何个人的片数、掰分、联用、开始、停用或换药方案。", "source": { "id": "src_c020c855fd353d39", "label": "DailyMed（NLM）：IMODIUM A-D 盐酸洛哌丁胺 2 mg 薄膜衣片当前美国 OTC 公开标签（Kenvue Brands；2025-09-23 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=01da76d0-1979-4c45-9d39-c72ae4e4ffe2", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "IMODIUM A-D 说明书放大阅读：2 mg、12 片包装与刻痕须一起核对", "en": "IMODIUM A-D label reading: read 2 mg, the 12-caplet pack and the score together" }, "summary": { "zh": "本模块以美国 DailyMed 公开标签为阅读入口，帮助核对 IMODIUM A-D、盐酸洛哌丁胺、每片 2 mg、口服薄膜衣片、12 片（2 板×6 片）包装和目标市场。它不提供个人片数、联用、停用、掰分或换药指令。", "en": "This module uses the U.S. DailyMed public label to check IMODIUM A-D, loperamide hydrochloride, 2 mg per caplet, film-coated oral-tablet form, the 12-caplet pack (2 blisters of 6) and target market. It does not provide individual tablet-count, combination, stopping, splitting or switching instructions." }, "checks": [ { "zh": "先将 IMODIUM A-D、盐酸洛哌丁胺、每片 2 mg、口服薄膜衣片、NDC 50580-317-06、12 片（2 板×6 片）纸盒和目标市场一起核对。2 mg 是这一准确片剂的标签标示量，不是网页给任何人计算片数的答案。", "en": "Check IMODIUM A-D, loperamide hydrochloride, 2 mg per caplet, film-coated oral-tablet form, NDC 50580-317-06, the 12-caplet carton (2 blisters of 6) and target market together. 2 mg is the labelled strength for this exact caplet, not a web answer to anyone's tablet count." }, { "zh": "标签的产品属性记录为白色椭圆片、刻印 IMO / 2 / MG，并显示可分为 2 pieces 的刻痕；这只是外观身份字段，不是“可以自行掰半、减量或按半片换算”的指令。是否可分割、如何使用须以实际产品现行标签和药师或医生核对为准。", "en": "The label records a white oval caplet, IMO / 2 / MG imprint and a 2-piece score. These are appearance identity fields, not an instruction to self-split, reduce or convert by half a caplet. Whether and how a product can be split must be checked against the current label for the actual product with a pharmacist or clinician." }, { "zh": "该标签警示超量使用可能造成严重心脏问题或死亡；并将黑便/血便、发热、黏液便、肝病、心律异常、其他处方药与症状超过两天或腹部胀大列为需要及时按标签和专业渠道处理的线索。不要用网站把这些线索变成自行加量、继续、停药、联用或替换方案。", "en": "The label warns that taking more than directed can cause serious heart problems or death. It also flags black or bloody stool, fever, mucus in stool, liver disease, abnormal heart rhythm, other prescription medicines, symptoms over two days or abdominal swelling as cues for prompt action through the label and professional channels. Do not turn these cues into a self-directed increase, continuation, stopping, combination or substitution plan from a website." }, { "zh": "IMODIUM 名称、包装图、颜色或刻印只能帮助定位来源，不能鉴定真伪、证明当前批准或决定个人是否适用。疑似过量、严重腹痛/腹胀、黑便/血便、晕厥、心悸或其他急性不适时，应优先使用当地紧急医疗支持。", "en": "The IMODIUM name, package image, colour or imprint can only help locate a source; they cannot authenticate a product, establish current approval or decide individual suitability. With suspected overdose, severe abdominal pain or swelling, black or bloody stool, fainting, palpitations or another acute problem, prioritise local emergency medical support." } ], "source": { "id": "src_c020c855fd353d39", "label": "DailyMed（NLM）：IMODIUM A-D 盐酸洛哌丁胺 2 mg 薄膜衣片当前美国 OTC 公开标签（Kenvue Brands；2025-09-23 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=01da76d0-1979-4c45-9d39-c72ae4e4ffe2", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "盐酸洛哌丁胺怎样被标签识别：止泻药类别不等于可自行调整", "en": "How the label identifies loperamide hydrochloride: an antidiarrheal class is not a self-adjustment rule" }, "summary": { "zh": "美国 DailyMed 标签将 IMODIUM A-D 标为止泻药。这个类别帮助读者找到准确产品、用途和警示；它不决定某个人腹泻的原因、是否适用，或是否能与另一种止泻、止痛、感冒或处方产品一起使用。", "en": "The U.S. DailyMed label identifies IMODIUM A-D as an antidiarrheal. This class helps readers locate the exact product, use and warnings; it does not determine why a person has diarrhoea, individual suitability or whether another antidiarrheal, pain, cold or prescription product can be used with it." }, "checks": [ { "zh": "“止泻药”是标签类别线索，不是病因诊断或自我分诊工具。血便、黑便、发热、持续或加重症状等情况需要当地专业渠道判断。", "en": "“Antidiarrheal” is a label-class clue, not a cause diagnosis or self-triage tool. Bloody or black stool, fever, persistent or worsening symptoms need assessment through local professional channels." }, { "zh": "同一类别、同一商品名或相同 2 mg 数字不表示不同片剂、液体、复方、不同市场包装或另一种止泻产品可以自行叠加、轮换、替代或按半片/毫升换算。", "en": "A shared class, brand name or 2 mg number does not make different tablets, liquids, combinations, market packs or another antidiarrheal self-combinable, alternatable, substitutable or convertible by half-caplet or millilitres." }, { "zh": "标签对超量风险与并用处方药的提示说明，完整药单和实际包装必须与症状一起核对；它不是网页将任何人划为“安全”或“不安全”的规则。", "en": "The label's cues about excess-use risk and other prescription medicines show why the full medicine list and actual pack must be reviewed alongside symptoms; they are not a web rule that sorts anyone into “safe” or “unsafe.”" } ], "source": { "id": "src_c020c855fd353d39", "label": "DailyMed（NLM）：IMODIUM A-D 盐酸洛哌丁胺 2 mg 薄膜衣片当前美国 OTC 公开标签（Kenvue Brands；2025-09-23 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=01da76d0-1979-4c45-9d39-c72ae4e4ffe2", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "IMODIUM A-D", "generic": "盐酸洛哌丁胺", "dosageFormClass": "口服薄膜衣片（本档案限定为盐酸洛哌丁胺 2 mg 片）" }, "labelSource": { "id": "src_c020c855fd353d39", "label": "DailyMed（NLM）：IMODIUM A-D 盐酸洛哌丁胺 2 mg 薄膜衣片当前美国 OTC 公开标签（Kenvue Brands；2025-09-23 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=01da76d0-1979-4c45-9d39-c72ae4e4ffe2", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "productRoutes": [ { "source": { "id": "src_c020c855fd353d39", "label": "DailyMed（NLM）：IMODIUM A-D 盐酸洛哌丁胺 2 mg 薄膜衣片当前美国 OTC 公开标签（Kenvue Brands；2025-09-23 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=01da76d0-1979-4c45-9d39-c72ae4e4ffe2", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "DailyMed 的 IMODIUM A-D（loperamide hydrochloride）美国 OTC 公开标签将本档案所列产品标示为每片 2 mg 的口服薄膜衣片。页面帮助阅读品牌、通用名、每片强度、准确包装和美国标签范围；不据此推定中国大陆或其他市场的批准、包装、持有人、原研关系、供应或可售资格。", "history": "标签中“caplet”、2 mg、泡罩数量和刻痕都属于这一准确产品的身份线索。它们不能变成网页上的个人片数、间隔、拆分、联用、停用或换药规则；名称相近的复方或液体产品需要逐项另核对。", "sourceDocuments": [ { "id": "src_c020c855fd353d39", "label": "DailyMed（NLM）：IMODIUM A-D 盐酸洛哌丁胺 2 mg 薄膜衣片当前美国 OTC 公开标签（Kenvue Brands；2025-09-23 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=01da76d0-1979-4c45-9d39-c72ae4e4ffe2", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_5ed30b676fbb9773", "label": "FDA Drugs@FDA 官方检索入口", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_lookup_entry", "documentKind": "regulatory_lookup", "market": "US", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } ], "applicationNumber": "DailyMed U.S. OTC label record", "approvalTimeline": [ { "date": "2025-09-23 updated", "title": { "zh": "DailyMed 公开标签版本", "en": "DailyMed public label version" }, "detail": { "zh": "本页链接 2025-09-23 updated 的 DailyMed 美国 OTC 公开标签作为可复核阅读入口。它标识该具体公开标签，不推定初始批准年份、NDA 编号、当前供应、持有人或其他市场状态。", "en": "This page links the 2025-09-23 updated DailyMed U.S. OTC public label as a traceable reading entry point. It identifies that specific public label and does not assert an original-approval year, NDA number, current availability, holder or another-market status." }, "source": { "id": "src_c020c855fd353d39", "label": "DailyMed: IMODIUM A-D loperamide hydrochloride current U.S. OTC label", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=01da76d0-1979-4c45-9d39-c72ae4e4ffe2", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "已链接 OTC 公开标签", "en": "OTC public label linked" }, "detail": { "zh": "仅对应本页所列 DailyMed OTC 文件。", "en": "Only the DailyMed OTC document listed on this page is linked." } }, { "market": { "zh": "中国大陆、欧盟、日本", "en": "Mainland China, EU, Japan" }, "status": { "zh": "待逐项建立市场记录", "en": "Market record not established" }, "detail": { "zh": "不从美国 OTC 标签推定当地批准、持有人、规格、供应或可售资格。", "en": "No local approval, holder, strength, supply or sale-eligibility conclusion is inferred from the U.S. OTC label." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "美国 OTC 标签能代表其他市场或个人用法吗？", "en": "Does a U.S. OTC label represent another market or personal use?" }, "answer": { "zh": "不能。它仅是这一具体美国公开标签的阅读入口；目标市场的现行文件和个人情况必须分别由专业人员核对。", "en": "No. It is only a reading entry point for this specific U.S. public label; the current target-market document and individual circumstances need separate professional review." } }, { "question": { "zh": "为什么不把 OTC 档案写成原始批准或原研结论？", "en": "Why does the OTC archive not state original approval or originator conclusions?" }, "answer": { "zh": "标签记录不足以证明这些结论。它们需要可追溯的产品、剂型、市场、时间和一手监管记录，并经人工审核。", "en": "A label record is insufficient to prove those conclusions. They require traceable product, dosage-form, market, date and primary regulatory records with human review." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "how-to-read-a-drug-label", "regulatory-sources-first" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/imodium-a-d/", "en": "https://origindrug.com/en/drugs/imodium-a-d/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "dulcolax-pink", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-24", "status": "published_traceable_archive" }, "names": { "brand": "DULCOLAX PINK", "generic": "比沙可啶", "aliases": [ "dulcolax", "dulcolax pink", "bisacodyl", "比沙可啶", "41167-0290-5" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "消化系统", "sourceArchiveMarket": "美国 OTC 公开标签档案（当前页面精确对应 5 mg、25 片泡罩装纸盒，NDC 41167-0290-5）", "dosageFormClass": "包衣缓释口服片（本档案限定为比沙可啶 5 mg 片）", "dosageFormClassCode": "oral_modified_release", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "未在本页推定（应按目标市场官方记录核验）", "archiveSponsorText": "DailyMed（NLM）公开标签档案；Chattem, Inc." }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [ "DULCOLAX PINK Stimulant Laxative 5 mg Tablets" ], "excludedProductCues": [ "DULCOLAX Soft Chews", "DULCOLAX liquid", "DULCOLAX suppository", "DULCOLAX stool softener", "bisacodyl 10 mg suppository" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-dulcolax-pink-bisacodyl-delayed-release-tablet-5mg-25ct-ndc-41167-0290-5", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v5，2025-02-06 发布", "en": "DailyMed SPL v5, published 6 Feb 2025" }, "dosageForm": { "zh": "DULCOLAX PINK 比沙可啶包衣缓释口服片", "en": "DULCOLAX PINK bisacodyl coated delayed-release oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 41167-0290-5", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片比沙可啶 5 mg；25 片泡罩装纸盒", "en": "Bisacodyl 5 mg per tablet; 25-tablet blister-pack carton" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=dulcolax-pink-stimulant-laxative-01.jpg&setid=fb5ad666-57b3-4b95-b5de-9db5d265925e&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "比沙可啶", "en": "bisacodyl" }, "value": 5, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、联用或换药规则", "en": "labelled amount per tablet; not an individual's tablet count, combination or switching rule" } } ], "concentration": null, "container": { "typeCode": "blister_carton", "typeLabel": { "zh": "25 片泡罩装纸盒", "en": "25-tablet blister-pack carton" }, "fill": null, "countPerPackage": 25, "countUnit": { "zh": "片/纸盒", "en": "tablets per carton" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-24", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 25, "unit": { "zh": "片/纸盒", "en": "tablets per carton" } }, "physicalClues": { "color": { "zh": "粉红色", "en": "pink" }, "shape": { "zh": "圆形包衣片", "en": "round coated tablet" }, "imprint": "DL", "scoreStatus": "not_scored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_f72dd27a009ad0e6", "label": "DailyMed（NLM）：DULCOLAX PINK 比沙可啶 5 mg 当前美国 OTC 公开标签（Chattem；SPL v5，2025-02-06 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=fb5ad666-57b3-4b95-b5de-9db5d265925e", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-dulcolax-pink-bisacodyl-delayed-release-tablet-5mg-25ct-ndc-41167-0290-5", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=dulcolax-pink-stimulant-laxative-01.jpg&setid=fb5ad666-57b3-4b95-b5de-9db5d265925e&type=img", "alt": "DULCOLAX PINK 比沙可啶在美国 DailyMed Chattem 公开标签中的 5 mg、NDC 41167-0290-5、25 片泡罩装纸盒展示面", "archiveMarket": "美国", "labelVersion": "DailyMed SPL v5（2025-02-06 发布）", "presentation": "DULCOLAX PINK 比沙可啶包衣缓释口服片：每片 5 mg，NDC 41167-0290-5，25 片泡罩装纸盒展示面。", "notice": "此图只对应美国 DailyMed 当前标签中的 DULCOLAX PINK、比沙可啶 5 mg、NDC 41167-0290-5 与 25 片泡罩装纸盒。它只帮助核对品牌、通用名、每片标示量、包衣口服片、包装数量与来源；不用于鉴定真伪，也不证明栓剂、软糖、液体、其他包装、其他市场、当前可得性、原研身份、可替代性，或任何个人的片数、掰分、联用、开始、停用或换药方案。", "source": { "id": "src_f72dd27a009ad0e6", "label": "DailyMed（NLM）：DULCOLAX PINK 比沙可啶 5 mg 当前美国 OTC 公开标签（Chattem；SPL v5，2025-02-06 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=fb5ad666-57b3-4b95-b5de-9db5d265925e", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "DULCOLAX PINK 说明书放大阅读：5 mg、25 片包装与“不要咀嚼或压碎”须一起看", "en": "DULCOLAX PINK label reading: read 5 mg, the 25-tablet pack and “do not chew or crush” together" }, "summary": { "zh": "本模块以美国 DailyMed 公开标签为阅读入口，帮助核对 DULCOLAX PINK、比沙可啶、每片 5 mg、包衣口服片、25 片包装和目标市场。它不提供个人片数、联用、停用、掰分或换药指令。", "en": "This module uses the U.S. DailyMed public label to check DULCOLAX PINK, bisacodyl, 5 mg per tablet, coated oral-tablet form, the 25-tablet pack and target market. It does not provide individual tablet-count, combination, stopping, splitting or switching instructions." }, "checks": [ { "zh": "先将 DULCOLAX PINK、比沙可啶、每片 5 mg、包衣口服片、NDC 41167-0290-5、25 片泡罩装纸盒和目标市场一起核对。5 mg 是这个准确片剂的标签标示量，不是网页给任何人计算片数的答案。", "en": "Check DULCOLAX PINK, bisacodyl, 5 mg per tablet, coated oral-tablet form, NDC 41167-0290-5, the 25-tablet blister-pack carton and target market together. 5 mg is the labelled strength for this exact tablet, not a web answer to anyone's tablet count." }, { "zh": "标签写明不要咀嚼或压碎片剂，并提示不要在服用抗酸药或牛奶后一小时内使用。此类文字是实际产品标签的阅读重点，不是网站给任何人的时间表、食物规则或替换方案。", "en": "The label says not to chew or crush the tablets and cautions against use within one hour after an antacid or milk. These are key reading points from the label for the actual product, not a website timetable, food rule or substitution plan for anyone." }, { "zh": "标签提示腹痛、恶心或呕吐、排便习惯突变超过两周、直肠出血、使用后仍未排便或需要使用通便药超过一周时，应按标签联系医生或药师。不要把这些警示改造成网页上的自行加量、继续、停药、联用或换药步骤。", "en": "The label directs readers with stomach pain, nausea or vomiting, a bowel-habit change lasting over two weeks, rectal bleeding, no bowel movement after use or a need for a laxative over one week to contact a clinician or pharmacist through the label. Do not turn these warnings into self-directed increase, continuation, stopping, combination or switching steps from a webpage." }, { "zh": "名称、粉红色外观、DL 刻印或包装图只能帮助定位来源，不能鉴定真伪、证明当前批准或决定个人是否适用。严重腹痛、晕厥、持续呕吐、出血或其他急性不适时，应优先使用当地紧急医疗支持。", "en": "The name, pink appearance, DL imprint or package image can only help locate a source; they cannot authenticate a product, establish current approval or decide individual suitability. With severe abdominal pain, fainting, persistent vomiting, bleeding or another acute problem, prioritise local emergency medical support." } ], "source": { "id": "src_f72dd27a009ad0e6", "label": "DailyMed（NLM）：DULCOLAX PINK 比沙可啶 5 mg 当前美国 OTC 公开标签（Chattem；SPL v5，2025-02-06 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=fb5ad666-57b3-4b95-b5de-9db5d265925e", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "比沙可啶怎样被标签识别：刺激性通便药类别不等于可自行调整", "en": "How the label identifies bisacodyl: a stimulant-laxative class is not a self-adjustment rule" }, "summary": { "zh": "美国 DailyMed 标签将 DULCOLAX PINK 标为刺激性通便药。这个类别帮助读者找到准确产品、用途与警示；它不决定便秘的原因、个人是否适用，或能否与另一种通便、止泻、止痛、减重或处方产品一起使用。", "en": "The U.S. DailyMed label identifies DULCOLAX PINK as a stimulant laxative. This class helps readers locate the exact product, use and warnings; it does not determine the cause of constipation, individual suitability or whether another bowel medicine, pain, weight-loss or prescription product can be used with it." }, "checks": [ { "zh": "“刺激性通便药”是标签类别线索，不是便秘病因诊断或自我分诊工具。突发、持续、加重或伴随出血、腹痛、呕吐等情况需要当地专业渠道判断。", "en": "“Stimulant laxative” is a label-class clue, not a diagnosis of why constipation occurs or a self-triage tool. Sudden, persistent, worsening symptoms or symptoms with bleeding, abdominal pain or vomiting need assessment through local professional channels." }, { "zh": "同一类别、同一品牌或相同 5 mg 数字不表示不同片剂、栓剂、液体、软糖、复方、不同市场包装或另一种通便产品可以自行叠加、轮换、替代或按半片/毫升换算。", "en": "A shared class, brand name or 5 mg number does not make different tablets, suppositories, liquids, chews, combinations, market packs or another laxative self-combinable, alternatable, substitutable or convertible by half-tablet or millilitres." }, { "zh": "标签的缓释片剂、不要咀嚼/压碎与抗酸药提示说明，完整药单、饮食/非处方产品和实际包装需要一起核对；它不是网页把任何人划为“安全”或“不安全”的规则。", "en": "The label's delayed-release tablet, do-not-chew/crush and antacid cues show why the complete medicine list, food/OTC products and actual pack need review together; they are not a web rule that sorts anyone into “safe” or “unsafe.”" } ], "source": { "id": "src_f72dd27a009ad0e6", "label": "DailyMed（NLM）：DULCOLAX PINK 比沙可啶 5 mg 当前美国 OTC 公开标签（Chattem；SPL v5，2025-02-06 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=fb5ad666-57b3-4b95-b5de-9db5d265925e", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "DULCOLAX PINK", "generic": "比沙可啶", "dosageFormClass": "包衣缓释口服片（本档案限定为比沙可啶 5 mg 片）" }, "labelSource": { "id": "src_f72dd27a009ad0e6", "label": "DailyMed（NLM）：DULCOLAX PINK 比沙可啶 5 mg 当前美国 OTC 公开标签（Chattem；SPL v5，2025-02-06 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=fb5ad666-57b3-4b95-b5de-9db5d265925e", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "productRoutes": [ { "source": { "id": "src_f72dd27a009ad0e6", "label": "DailyMed（NLM）：DULCOLAX PINK 比沙可啶 5 mg 当前美国 OTC 公开标签（Chattem；SPL v5，2025-02-06 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=fb5ad666-57b3-4b95-b5de-9db5d265925e", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "DailyMed 的 DULCOLAX PINK（bisacodyl）美国 OTC 公开标签将本档案所列产品标示为每片 5 mg 的包衣口服片。页面帮助阅读品牌、通用名、每片强度、准确包装与美国标签范围；不据此推定中国大陆或其他市场的批准、包装、持有人、原研关系、供应或可售资格。", "history": "“隔夜”“缓释”“5 mg”和粉红色外观是这一准确产品的标签与外观线索，不是网页上的个人片数、间隔、掰分、联用、停用或换药规则。栓剂、软糖、液体或其他通便产品须逐项重新核对。", "sourceDocuments": [ { "id": "src_f72dd27a009ad0e6", "label": "DailyMed（NLM）：DULCOLAX PINK 比沙可啶 5 mg 当前美国 OTC 公开标签（Chattem；SPL v5，2025-02-06 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=fb5ad666-57b3-4b95-b5de-9db5d265925e", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_5ed30b676fbb9773", "label": "FDA Drugs@FDA 官方检索入口", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_lookup_entry", "documentKind": "regulatory_lookup", "market": "US", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } ], "applicationNumber": "DailyMed U.S. OTC label record", "approvalTimeline": [ { "date": "DailyMed SPL v5, published 2025-02-06", "title": { "zh": "DailyMed 公开标签版本", "en": "DailyMed public label version" }, "detail": { "zh": "本页链接 DailyMed SPL v5, published 2025-02-06 的 DailyMed 美国 OTC 公开标签作为可复核阅读入口。它标识该具体公开标签，不推定初始批准年份、NDA 编号、当前供应、持有人或其他市场状态。", "en": "This page links the DailyMed SPL v5, published 2025-02-06 DailyMed U.S. OTC public label as a traceable reading entry point. It identifies that specific public label and does not assert an original-approval year, NDA number, current availability, holder or another-market status." }, "source": { "id": "src_f72dd27a009ad0e6", "label": "DailyMed: DULCOLAX PINK bisacodyl current U.S. OTC label", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=fb5ad666-57b3-4b95-b5de-9db5d265925e", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "已链接 OTC 公开标签", "en": "OTC public label linked" }, "detail": { "zh": "仅对应本页所列 DailyMed OTC 文件。", "en": "Only the DailyMed OTC document listed on this page is linked." } }, { "market": { "zh": "中国大陆、欧盟、日本", "en": "Mainland China, EU, Japan" }, "status": { "zh": "待逐项建立市场记录", "en": "Market record not established" }, "detail": { "zh": "不从美国 OTC 标签推定当地批准、持有人、规格、供应或可售资格。", "en": "No local approval, holder, strength, supply or sale-eligibility conclusion is inferred from the U.S. OTC label." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "美国 OTC 标签能代表其他市场或个人用法吗？", "en": "Does a U.S. OTC label represent another market or personal use?" }, "answer": { "zh": "不能。它仅是这一具体美国公开标签的阅读入口；目标市场的现行文件和个人情况必须分别由专业人员核对。", "en": "No. It is only a reading entry point for this specific U.S. public label; the current target-market document and individual circumstances need separate professional review." } }, { "question": { "zh": "为什么不把 OTC 档案写成原始批准或原研结论？", "en": "Why does the OTC archive not state original approval or originator conclusions?" }, "answer": { "zh": "标签记录不足以证明这些结论。它们需要可追溯的产品、剂型、市场、时间和一手监管记录，并经人工审核。", "en": "A label record is insufficient to prove those conclusions. They require traceable product, dosage-form, market, date and primary regulatory records with human review." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "how-to-read-a-drug-label", "regulatory-sources-first" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/dulcolax-pink/", "en": "https://origindrug.com/en/drugs/dulcolax-pink/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "mucinex", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-24", "status": "published_traceable_archive" }, "names": { "brand": "MUCINEX", "generic": "愈创甘油醚", "aliases": [ "guaifenesin", "愈创甘油醚", "mucinex", "mucinex 600 mg", "63824-008-32" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "呼吸系统", "sourceArchiveMarket": "美国 OTC 公开标签档案（当前页面精确对应每片 600 mg、20 片泡罩装纸盒，NDC 63824-008-32）", "dosageFormClass": "缓释双层口服片（本档案限定为愈创甘油醚 600 mg 片）", "dosageFormClassCode": "oral_modified_release", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "未在本页推定（应按目标市场官方记录核验）", "archiveSponsorText": "DailyMed（NLM）公开标签档案；Reckitt Benckiser LLC" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [ "MUCINEX 600 mg Extended-Release Tablets" ], "excludedProductCues": [ "MUCINEX DM", "MUCINEX D", "MUCINEX Fast-Max", "MUCINEX liquid", "guaifenesin immediate-release" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-mucinex-guaifenesin-extended-release-tablet-600mg-20ct-ndc-63824-008-32", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v20，2026-05-28 发布", "en": "DailyMed SPL v20, published 28 May 2026" }, "dosageForm": { "zh": "MUCINEX 愈创甘油醚缓释双层口服片", "en": "MUCINEX guaifenesin extended-release bi-layer oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 63824-008-32", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片愈创甘油醚 600 mg；20 片泡罩装纸盒", "en": "Guaifenesin 600 mg per tablet; 20-tablet blister-pack carton" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=63824-008+full+label.jpg&setid=dd379cdd-90ab-42e0-ad89-f50d3220f611", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "愈创甘油醚", "en": "guaifenesin" }, "value": 600, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、联用、加减或换药规则", "en": "labelled amount per tablet; not an individual's tablet count, combination, adjustment or switching rule" } } ], "concentration": null, "container": { "typeCode": "blister_carton", "typeLabel": { "zh": "20 片泡罩装纸盒", "en": "20-tablet blister-pack carton" }, "fill": null, "countPerPackage": 20, "countUnit": { "zh": "片/纸盒", "en": "tablets per carton" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-24", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 20, "unit": { "zh": "片/纸盒", "en": "tablets per carton" } }, "physicalClues": { "color": { "zh": "白蓝双色", "en": "white and blue" }, "shape": { "zh": "椭圆形缓释双层片", "en": "oval extended-release bi-layer tablet" }, "imprint": "Mucinex / 600", "scoreStatus": "not_scored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_5d1d76cb1d641b2f", "label": "DailyMed（NLM）：MUCINEX 愈创甘油醚 600 mg 缓释双层片当前美国 OTC 公开标签（Reckitt Benckiser；SPL v20，2026-05-28 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?audience=consumer&setid=dd379cdd-90ab-42e0-ad89-f50d3220f611", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-mucinex-guaifenesin-extended-release-tablet-600mg-20ct-ndc-63824-008-32", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=63824-008+full+label.jpg&setid=dd379cdd-90ab-42e0-ad89-f50d3220f611", "alt": "MUCINEX 愈创甘油醚在美国 DailyMed Reckitt Benckiser 公开标签中的 600 mg、NDC 63824-008-32、20 片泡罩装纸盒展示面", "archiveMarket": "美国", "labelVersion": "DailyMed SPL v20（2026-05-28 发布）", "presentation": "MUCINEX 愈创甘油醚缓释双层口服片：每片 600 mg，NDC 63824-008-32，20 片泡罩装纸盒展示面。", "notice": "此图只对应美国 DailyMed 当前标签中的 MUCINEX、愈创甘油醚 600 mg、NDC 63824-008-32 与 20 片泡罩装纸盒。它只帮助核对品牌、通用名、每片标示量、缓释双层片、包装数量与来源；不用于鉴定真伪，也不证明 MUCINEX DM、MUCINEX D、液体、其他包装、其他市场、当前可得性、原研身份、可替代性，或任何个人的片数、掰分、联用、开始、停用或换药方案。", "source": { "id": "src_5d1d76cb1d641b2f", "label": "DailyMed（NLM）：MUCINEX 愈创甘油醚 600 mg 缓释双层片当前美国 OTC 公开标签（Reckitt Benckiser；SPL v20，2026-05-28 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?audience=consumer&setid=dd379cdd-90ab-42e0-ad89-f50d3220f611", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "MUCINEX 说明书放大阅读：600 mg、缓释双层片与“不要掰开/咀嚼/压碎”须一起看", "en": "MUCINEX label reading: read 600 mg, the extended-release bi-layer tablet and “do not break, chew or crush” together" }, "summary": { "zh": "本模块以美国 DailyMed 公开标签为阅读入口，帮助核对 MUCINEX、愈创甘油醚、每片 600 mg、缓释双层口服片、20 片包装和目标市场。它不提供个人片数、联用、停用、掰分或换药指令。", "en": "This module uses the U.S. DailyMed public label to check MUCINEX, guaifenesin, 600 mg per tablet, the extended-release bi-layer oral tablet, the 20-tablet pack and target market. It does not provide individual tablet-count, combination, stopping, splitting or switching instructions." }, "checks": [ { "zh": "先将 MUCINEX、愈创甘油醚、每片 600 mg、缓释双层口服片、NDC 63824-008-32、20 片泡罩装纸盒和目标市场一起核对。600 mg 是这一准确片剂的标签标示量，不是网页给任何人计算片数的答案。", "en": "Check MUCINEX, guaifenesin, 600 mg per tablet, the extended-release bi-layer oral tablet, NDC 63824-008-32, the 20-tablet blister-pack carton and target market together. 600 mg is the labelled strength for this exact tablet, not a web answer to anyone's tablet count." }, { "zh": "标签写明不要掰开、咀嚼或压碎缓释片。这个文字说明“缓释”是产品身份和标签阅读重点，不等于可按普通片的经验拆分、研磨、换算或替代。是否能分割、怎样使用必须按实际包装的现行标签与药师或医生核对。", "en": "The label says not to break, chew or crush the extended-release tablet. This makes “extended release” an identity and label-reading point, not permission to split, grind, convert or substitute it using experience with an ordinary tablet. Whether and how a product can be split must be checked against the current label for the actual pack with a pharmacist or clinician." }, { "zh": "标签提示持续或慢性咳嗽、痰很多、咳嗽超过七天、反复或伴发热、皮疹、持续头痛时需要按标签和专业渠道进一步处理。不要用网站把这些线索变成自行加量、继续、停药、联用或替换方案。", "en": "The label flags persistent or chronic cough, a cough with much mucus, a cough lasting more than seven days, recurrence, or cough with fever, rash or persistent headache for further action through the label and professional channels. Do not turn these cues into a self-directed increase, continuation, stopping, combination or substitution plan from a website." }, { "zh": "MUCINEX 名称、包装图、白蓝双色或刻印只能帮助定位来源，不能鉴定真伪、证明当前批准或决定个人是否适用。疑似过量、呼吸困难、症状加重或不确定下一步时，应优先使用当地医疗支持。", "en": "The MUCINEX name, package image, white-and-blue colour or imprint can only help locate a source; they cannot authenticate a product, establish current approval or decide individual suitability. With suspected overdose, breathing difficulty, worsening symptoms or uncertainty about the next step, prioritise local medical support." } ], "source": { "id": "src_5d1d76cb1d641b2f", "label": "DailyMed（NLM）：MUCINEX 愈创甘油醚 600 mg 缓释双层片当前美国 OTC 公开标签（Reckitt Benckiser；SPL v20，2026-05-28 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?audience=consumer&setid=dd379cdd-90ab-42e0-ad89-f50d3220f611", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "愈创甘油醚怎样被标签识别：祛痰药类别不等于可自行叠加", "en": "How the label identifies guaifenesin: an expectorant class is not automatically combinable" }, "summary": { "zh": "美国 DailyMed 标签把 MUCINEX 标为祛痰药。这个类别帮助读者找到准确产品、用途和警示；它不决定某个人咳嗽的原因、是否适用，或能否与另一种止咳、感冒、过敏或处方产品一起使用。", "en": "The U.S. DailyMed label identifies MUCINEX as an expectorant. This class helps readers locate the exact product, use and warnings; it does not determine why a person is coughing, individual suitability or whether another cough, cold, allergy or prescription product can be used with it." }, "checks": [ { "zh": "“祛痰药”是标签类别线索，不是症状诊断或自我分诊工具。持续、加重、呼吸相关或不明原因的症状应由当地专业渠道判断。", "en": "“Expectorant” is a label-class clue, not a symptom-diagnosis or self-triage tool. Persistent, worsening, breathing-related or unexplained symptoms need assessment through local professional channels." }, { "zh": "同一类别、同一品牌或相同 600 mg 数字不表示普通片、液体、复方感冒产品或另一种止咳产品可以自行叠加、轮换、替代或按毫克数换算。", "en": "A shared class, brand name or 600 mg number does not make immediate-release tablets, liquids, combination cold products or another cough product self-combinable, alternatable, substitutable or convertible by milligrams." }, { "zh": "“缓释”与“即时和缓释”的标签文字说明，完整药单和实际包装必须一起核对；它不是网页将任何人划为“安全”或“不安全”的规则。", "en": "The label wording about extended release and “immediate and extended release” shows why the complete medicine list and actual pack must be reviewed together; it is not a web rule that sorts anyone into “safe” or “unsafe.”" } ], "source": { "id": "src_5d1d76cb1d641b2f", "label": "DailyMed（NLM）：MUCINEX 愈创甘油醚 600 mg 缓释双层片当前美国 OTC 公开标签（Reckitt Benckiser；SPL v20，2026-05-28 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?audience=consumer&setid=dd379cdd-90ab-42e0-ad89-f50d3220f611", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "MUCINEX", "generic": "愈创甘油醚", "dosageFormClass": "缓释双层口服片（本档案限定为愈创甘油醚 600 mg 片）" }, "labelSource": { "id": "src_5d1d76cb1d641b2f", "label": "DailyMed（NLM）：MUCINEX 愈创甘油醚 600 mg 缓释双层片当前美国 OTC 公开标签（Reckitt Benckiser；SPL v20，2026-05-28 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?audience=consumer&setid=dd379cdd-90ab-42e0-ad89-f50d3220f611", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "productRoutes": [ { "source": { "id": "src_5d1d76cb1d641b2f", "label": "DailyMed（NLM）：MUCINEX 愈创甘油醚 600 mg 缓释双层片当前美国 OTC 公开标签（Reckitt Benckiser；SPL v20，2026-05-28 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?audience=consumer&setid=dd379cdd-90ab-42e0-ad89-f50d3220f611", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "DailyMed 的 MUCINEX（guaifenesin）美国 OTC 公开标签将本档案所列产品标示为每片 600 mg 的缓释双层口服片。页面帮助阅读品牌、通用名、每片强度、缓释剂型、准确包装与美国标签范围；不据此推定中国大陆或其他市场的批准、包装、持有人、原研关系、供应或可售资格。", "history": "“12 小时”“即时与缓释”“600 mg”和白蓝双色片是这一准确产品的标签与外观线索。它们不形成网页上的个人片数、间隔、掰分、联用、停用或换药规则；含右美沙芬、伪麻黄碱或多种感冒成分的 MUCINEX 产品须逐项重新核对。", "sourceDocuments": [ { "id": "src_5d1d76cb1d641b2f", "label": "DailyMed（NLM）：MUCINEX 愈创甘油醚 600 mg 缓释双层片当前美国 OTC 公开标签（Reckitt Benckiser；SPL v20，2026-05-28 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?audience=consumer&setid=dd379cdd-90ab-42e0-ad89-f50d3220f611", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_5ed30b676fbb9773", "label": "FDA Drugs@FDA 官方检索入口", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_lookup_entry", "documentKind": "regulatory_lookup", "market": "US", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } ], "applicationNumber": "DailyMed U.S. OTC label record", "approvalTimeline": [ { "date": "DailyMed SPL v20, published 2026-05-28", "title": { "zh": "DailyMed 公开标签版本", "en": "DailyMed public label version" }, "detail": { "zh": "本页链接 DailyMed SPL v20, published 2026-05-28 的 DailyMed 美国 OTC 公开标签作为可复核阅读入口。它标识该具体公开标签，不推定初始批准年份、NDA 编号、当前供应、持有人或其他市场状态。", "en": "This page links the DailyMed SPL v20, published 2026-05-28 DailyMed U.S. OTC public label as a traceable reading entry point. It identifies that specific public label and does not assert an original-approval year, NDA number, current availability, holder or another-market status." }, "source": { "id": "src_5d1d76cb1d641b2f", "label": "DailyMed: MUCINEX guaifenesin extended-release tablet current U.S. OTC label", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?audience=consumer&setid=dd379cdd-90ab-42e0-ad89-f50d3220f611", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "已链接 OTC 公开标签", "en": "OTC public label linked" }, "detail": { "zh": "仅对应本页所列 DailyMed OTC 文件。", "en": "Only the DailyMed OTC document listed on this page is linked." } }, { "market": { "zh": "中国大陆、欧盟、日本", "en": "Mainland China, EU, Japan" }, "status": { "zh": "待逐项建立市场记录", "en": "Market record not established" }, "detail": { "zh": "不从美国 OTC 标签推定当地批准、持有人、规格、供应或可售资格。", "en": "No local approval, holder, strength, supply or sale-eligibility conclusion is inferred from the U.S. OTC label." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "美国 OTC 标签能代表其他市场或个人用法吗？", "en": "Does a U.S. OTC label represent another market or personal use?" }, "answer": { "zh": "不能。它仅是这一具体美国公开标签的阅读入口；目标市场的现行文件和个人情况必须分别由专业人员核对。", "en": "No. It is only a reading entry point for this specific U.S. public label; the current target-market document and individual circumstances need separate professional review." } }, { "question": { "zh": "为什么不把 OTC 档案写成原始批准或原研结论？", "en": "Why does the OTC archive not state original approval or originator conclusions?" }, "answer": { "zh": "标签记录不足以证明这些结论。它们需要可追溯的产品、剂型、市场、时间和一手监管记录，并经人工审核。", "en": "A label record is insufficient to prove those conclusions. They require traceable product, dosage-form, market, date and primary regulatory records with human review." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "how-to-read-a-drug-label", "regulatory-sources-first" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/mucinex/", "en": "https://origindrug.com/en/drugs/mucinex/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "ofev", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-22", "status": "published_traceable_archive" }, "names": { "brand": "OFEV", "generic": "尼达尼布", "aliases": [ "OFEV", "nintedanib", "nintedanib esylate", "尼达尼布" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "呼吸系统", "sourceArchiveMarket": "美国 DailyMed 当前 OFEV（nintedanib）口服胶囊标签，SPL v21，2025-11-20 生效。该记录只对应美国标签所列产品，不推定中国大陆或其他市场的当前批准、供应或可得性。", "dosageFormClass": "口服胶囊：100 mg、150 mg（DailyMed 当前美国公开标签所列；各 60 粒瓶装/纸盒记录）", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "2014（DailyMed 当前美国公开标签所列初始批准）", "archiveSponsorText": "Boehringer Ingelheim Pharmaceuticals, Inc. / DailyMed 美国公开标签" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [ "nintedanib tablet", "尼达尼布片", "nintedanib injection", "尼达尼布注射液" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-ofev-nintedanib-150mg-60capsule-bottle-carton-ndc-0597-0145-60", "marketCode": "US", "labelVersion": { "zh": "DailyMed 美国当前公开标签（2025-05 修订）", "en": "Current U.S. DailyMed public label (revised May 2025)" }, "dosageForm": { "zh": "口服软胶囊", "en": "oral soft capsule" }, "route": { "zh": "口服（标签产品身份字段）", "en": "oral (label product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 0597-0145-60", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_capsule", "primaryDisplay": { "zh": "OFEV 尼达尼布 150 mg；60 粒瓶装纸盒（NDC 0597-0145-60）", "en": "OFEV nintedanib 150 mg; 60-capsule bottle carton (NDC 0597-0145-60)" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=ofev-09.jpg&setid=da1c9f37-779e-4682-816f-93d0faa4cfc9&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "尼达尼布", "en": "nintedanib" }, "value": 150, "unit": "mg", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒胶囊的标签量；不是个人用量或换算", "en": "labelled amount per capsule; not an individual amount or conversion" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "带儿童安全封口的 HDPE 瓶", "en": "HDPE bottle with child-resistant closure" }, "fill": null, "countPerPackage": 60, "countUnit": { "zh": "粒/瓶装纸盒", "en": "capsules per bottle carton" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-22", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 60, "unit": { "zh": "粒胶囊/瓶装纸盒", "en": "capsules per bottle carton" } }, "physicalClues": { "color": { "zh": "棕色不透明（标签描述）", "en": "brown, opaque (label description)" }, "shape": { "zh": "长圆形软胶囊（标签描述）", "en": "oblong soft capsule (label description)" }, "imprint": "Boehringer Ingelheim company symbol / 150", "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_4976d8d99a5c79b5", "label": "DailyMed（NLM）：OFEV 尼达尼布当前美国公开标签（Boehringer Ingelheim；2025-05 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=da1c9f37-779e-4682-816f-93d0faa4cfc9", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-ofev-nintedanib-100mg-60capsule-bottle-carton-ndc-0597-0143-60", "marketCode": "US", "labelVersion": { "zh": "DailyMed 美国当前公开标签（2025-05 修订）", "en": "Current U.S. DailyMed public label (revised May 2025)" }, "dosageForm": { "zh": "口服软胶囊", "en": "oral soft capsule" }, "route": { "zh": "口服（标签产品身份字段）", "en": "oral (label product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 0597-0143-60", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_capsule", "primaryDisplay": { "zh": "OFEV 尼达尼布 100 mg；60 粒瓶装纸盒（NDC 0597-0143-60）", "en": "OFEV nintedanib 100 mg; 60-capsule bottle carton (NDC 0597-0143-60)" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=ofev-10.jpg&setid=da1c9f37-779e-4682-816f-93d0faa4cfc9&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "尼达尼布", "en": "nintedanib" }, "value": 100, "unit": "mg", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒胶囊的标签量；不是个人用量或换算", "en": "labelled amount per capsule; not an individual amount or conversion" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "带儿童安全封口的 HDPE 瓶", "en": "HDPE bottle with child-resistant closure" }, "fill": null, "countPerPackage": 60, "countUnit": { "zh": "粒/瓶装纸盒", "en": "capsules per bottle carton" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-22", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 60, "unit": { "zh": "粒胶囊/瓶装纸盒", "en": "capsules per bottle carton" } }, "physicalClues": { "color": { "zh": "桃色不透明（标签描述）", "en": "peach, opaque (label description)" }, "shape": { "zh": "长圆形软胶囊（标签描述）", "en": "oblong soft capsule (label description)" }, "imprint": "Boehringer Ingelheim company symbol / 100", "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_4976d8d99a5c79b5", "label": "DailyMed（NLM）：OFEV 尼达尼布当前美国公开标签（Boehringer Ingelheim；2025-05 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=da1c9f37-779e-4682-816f-93d0faa4cfc9", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-ofev-nintedanib-150mg-60capsule-bottle-carton-ndc-0597-0145-60", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=ofev-09.jpg&setid=da1c9f37-779e-4682-816f-93d0faa4cfc9&type=img", "alt": "OFEV 尼达尼布在美国 DailyMed 当前标签中的 150 mg、NDC 0597-0145-60、60 粒瓶装纸盒展示面", "archiveMarket": "美国", "labelVersion": "DailyMed 美国当前公开标签（2025-05 修订）", "presentation": "OFEV 尼达尼布：每粒 150 mg，NDC 0597-0145-60，60 粒瓶装纸盒。", "notice": "此图只对应美国 DailyMed 当前标签中的 OFEV、尼达尼布、每粒 150 mg、NDC 0597-0145-60 与 60 粒瓶装纸盒。它只帮助核对品牌、通用名、每粒标签量、包装数量和来源；不用于鉴定真伪，也不证明 100 mg 产品、其他包装、其他市场、当前可得性、原研身份、可替代性，或任何个人的胶囊数量、时间、开始、停用、联用或换药方案。", "source": { "id": "src_4976d8d99a5c79b5", "label": "DailyMed（NLM）：OFEV 尼达尼布当前美国公开标签（Boehringer Ingelheim；2025-05 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=da1c9f37-779e-4682-816f-93d0faa4cfc9", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "OFEV 说明书放大阅读：100、150 mg 是胶囊身份，不是“该吃几粒”", "en": "OFEV label reading: 100 and 150 mg identify capsules; they do not answer “how many capsules”" }, "summary": { "zh": "本模块只阅读 DailyMed 当前美国标签中的 OFEV、尼达尼布、口服胶囊和每粒标示量。它把标签的产品身份和安全核对线索放在一起，但不提供个人用量、开始、停用、换药、联用或购买方案。", "en": "This module reads only OFEV, nintedanib, oral capsules and labelled amount per capsule in the current U.S. DailyMed label. It places product identity and safety-review cues together, but provides no individual use, initiation, stopping, switching, co-use or purchase plan." }, "checks": [ { "zh": "把 OFEV、尼达尼布、口服胶囊、每粒 100 或 150 mg、实际包装和目标市场一起核对。mg 是每一粒准确胶囊的标签量，不是网页可以换算成个人每天该用多少粒的规则，也不能据此把另一种药、另一市场产品或另一剂型自行互换。", "en": "Check OFEV, nintedanib, oral-capsule form, the stated 100 or 150 mg per capsule, the actual pack and target market together. Mg is the labelled amount in an exact capsule, not a web rule for how many capsules an individual should use, and it cannot self-convert another medicine, market product or form." }, { "zh": "该美国标签写明胶囊应整粒吞服，不应咀嚼、打开或压碎；这是这个准确胶囊产品的标签文字，不能外推为其他胶囊或片剂的操作结论。吞咽困难、漏用、包装不一致或想改变使用方式时，应先带实际药盒和完整药单请药师或开方团队核对。", "en": "The U.S. label says the capsules should be swallowed whole and not chewed, opened or crushed. This is label wording for this exact capsule product and cannot be generalised to another capsule or tablet. For swallowing difficulty, missed use, a mismatched pack or a contemplated change in use, first have a pharmacist or prescribing team review the actual pack and complete medicine list." }, { "zh": "标签列出肝功能、胃肠道问题、出血风险、动脉血栓事件及多药并用等需要专业复核的线索。它们不是网页可以决定“能不能同时用、谁先停、怎样错开”的答案；出现呕血、黑便、胸部不适、呼吸困难、晕厥或其他急性严重不适时，应优先使用当地紧急医疗渠道。", "en": "The label identifies liver context, gastrointestinal problems, bleeding risk, arterial thromboembolic events and multiple medicines as review cues. They are not a webpage answer to whether products can be used together, which should stop first or how to space them; vomiting blood, black stools, chest discomfort, breathing difficulty, fainting or another acute serious concern require local urgent medical care first." }, { "zh": "若同时有抗凝药、抗血小板药、非处方止痛药、草本或补充剂，或正在接受其他处方治疗，应把所有实际包装、开始/变更时间和不适一起交给药师或医疗团队核对。不要仅按“肺部用药”“纤维化”或相近毫克数字自行叠加、轮换或替代。", "en": "If anticoagulants, antiplatelet medicines, OTC pain products, herbs or supplements, or other prescriptions are also present, have a pharmacist or care team review every actual pack, start/change timing and concerns together. Do not self-combine, alternate or substitute based only on words such as “lung medicine,” “fibrosis” or similar milligram figures." } ], "source": { "id": "src_4976d8d99a5c79b5", "label": "DailyMed (NLM): current OFEV nintedanib U.S. public label (SPL v21, effective 2025-11-20; capsule identity and warnings)", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=da1c9f37-779e-4682-816f-93d0faa4cfc9", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "尼达尼布怎样起作用：标签将其描述为激酶抑制剂", "en": "How nintedanib works: the label identifies it as a kinase inhibitor" }, "summary": { "zh": "DailyMed 当前标签将 OFEV 描述为激酶抑制剂。这个机制词帮助理解标签的药理分类，却不预测个人病因、肺功能变化、耐受性、胶囊数量、是否适合、联用方案或是否需要换药。", "en": "The current DailyMed label describes OFEV as a kinase inhibitor. This mechanism term helps explain the label's pharmacologic classification; it does not predict an individual's cause, lung-function change, tolerance, capsule count, suitability, co-use plan or whether to switch." }, "checks": [ { "zh": "“激酶抑制剂”是药理路径用语，不表示所有同类药、相近用途产品或不同市场的尼达尼布产品可以自行互换、叠加或按 mg 对等换算。", "en": "“Kinase inhibitor” is pharmacologic-pathway wording; it does not establish that all related medicines, products with similar uses or nintedanib products from different markets can be self-interchanged, combined or milligram-converted." }, { "zh": "同样出现“肺纤维化”“间质性肺疾病”或“激酶”文字，也不能证明两盒药适用于同一疾病、同一人或同一市场。应先核对准确商品名、通用名、胶囊强度、目标市场标签和完整药单。", "en": "Shared words such as “pulmonary fibrosis,” “interstitial lung disease” or “kinase” do not establish that two packs apply to the same condition, person or market. First check the exact brand, generic name, capsule strength, target-market label and complete medicine list." }, { "zh": "机制解释不能替代标签、药物警戒或完整药单核对。涉及新增药物、出血或胃肠道相关不适、肝功能问题、漏用、掰开/打开胶囊或改变治疗时，应由了解实际产品和目标市场标签的专业人员审阅。", "en": "A mechanism explanation does not replace label, pharmacovigilance or complete-medicine-list review. Adding a medicine, bleeding or gastrointestinal concerns, liver questions, missed use, opening a capsule or changing treatment requires professional review of the actual product and target-market label." } ], "source": { "id": "src_4976d8d99a5c79b5", "label": "DailyMed (NLM): current OFEV nintedanib U.S. public label (SPL v21; Clinical Pharmacology)", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=da1c9f37-779e-4682-816f-93d0faa4cfc9", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "OFEV", "generic": "尼达尼布", "dosageFormClass": "口服胶囊：100 mg、150 mg（DailyMed 当前美国公开标签所列；各 60 粒瓶装/纸盒记录）" }, "labelSource": { "id": "src_4976d8d99a5c79b5", "label": "DailyMed (NLM): current OFEV nintedanib U.S. public label (SPL v21, effective 2025-11-20)", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=da1c9f37-779e-4682-816f-93d0faa4cfc9", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "productRoutes": [ { "source": { "id": "src_4976d8d99a5c79b5", "label": "DailyMed (NLM): current OFEV nintedanib U.S. public label (SPL v21, effective 2025-11-20)", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=da1c9f37-779e-4682-816f-93d0faa4cfc9", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "DailyMed 当前美国公开标签将 OFEV 列为尼达尼布口服胶囊，并列出 100 mg、150 mg 两种每粒标示量。本页帮助读者把商品名、通用名、胶囊、每粒标示量、美国标签和药物警戒入口逐项对应；它不把毫克数字变成个人每次/每天用量、开始、停用、联用、换药或购买建议。", "history": "DailyMed 标签列示 OFEV 的美国初始批准为 2014，且页面标示 NDA 205832。该档案仅定位这一美国公开标签：同一通用名的其他厂商、其他市场、其他包装或不同标签版本，均必须按实际药盒和目标市场现行官方资料分别核对。", "sourceDocuments": [ { "id": "src_4976d8d99a5c79b5", "label": "DailyMed (NLM): current OFEV nintedanib U.S. public label (SPL v21, effective 2025-11-20)", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=da1c9f37-779e-4682-816f-93d0faa4cfc9", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_5618be3b3fbcbdcf", "label": "FDA: OFEV nintedanib orphan-drug designation and approval record for IPF (2014)", "url": "https://www.accessdata.fda.gov/scripts/opdlisting/oopd/detailedIndex.cfm?cfgridkey=344511", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "regulatory_reference", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } ], "applicationNumber": "NDA 205832", "approvalTimeline": [ { "date": "2014", "title": { "zh": "FDA 标签所列美国初始批准年份", "en": "Initial U.S. approval year listed in the FDA label" }, "detail": { "zh": "本页链接的 FDA 标签档案列示 Initial U.S. Approval: 2014。该历史定位不等同于当前批准、可得性、持有人或其他市场状态。", "en": "The FDA label archive linked here lists Initial U.S. Approval: 2014. This historical locator is not a conclusion about current approval, availability, holder or another market." }, "source": { "id": "src_4976d8d99a5c79b5", "label": "DailyMed: current OFEV nintedanib U.S. public label, SPL v21", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=da1c9f37-779e-4682-816f-93d0faa4cfc9", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, { "date": "2025-11-20", "title": { "zh": "FDA 标签档案版本", "en": "FDA label archive version" }, "detail": { "zh": "本页链接 2025-11-20 的 FDA 标签档案作为可复核阅读入口。现行标签、规格、适应症和安全信息必须另行以目标市场当前文件核对。", "en": "This page links the 2025-11-20 FDA label archive as a traceable reading entry point. Current labeling, strength, indication and safety information require separate verification against the target market’s current document." }, "source": { "id": "src_4976d8d99a5c79b5", "label": "DailyMed: current OFEV nintedanib U.S. public label, SPL v21", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=da1c9f37-779e-4682-816f-93d0faa4cfc9", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "已链接公开标签档案", "en": "Public label archive linked" }, "detail": { "zh": "仅对应本页所列 FDA 文件。", "en": "Only the FDA document listed on this page is linked." } }, { "market": { "zh": "中国大陆、欧盟、日本", "en": "Mainland China, EU, Japan" }, "status": { "zh": "待逐项建立市场记录", "en": "Market record not established" }, "detail": { "zh": "不从美国标签档案推定当地批准、持有人、规格、供应或可售资格。", "en": "No local approval, holder, strength, supply or sale-eligibility conclusion is inferred from the U.S. label archive." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "标签档案能代表现在的产品信息吗？", "en": "Does a label archive represent current product information?" }, "answer": { "zh": "不能自动代表。档案用于定位来源；需要以目标市场的现行官方标签逐项复核。", "en": "Not automatically. The archive locates a source; each point needs verification against the target market’s current official label." } }, { "question": { "zh": "为什么这里不展示价格或原研/仿制结论？", "en": "Why are price and originator/generic conclusions not shown?" }, "answer": { "zh": "这些结论需要产品、剂型、规格、包装、市场、日期和原始记录分别齐全并经人工审核；单一标签文件不足以支持。", "en": "Those conclusions require separately complete and human-reviewed product, dosage-form, strength, pack, market, date and primary-record fields; one label file is insufficient." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "how-to-read-a-drug-label", "regulatory-sources-first" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/ofev/", "en": "https://origindrug.com/en/drugs/ofev/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "xalatan", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-21", "status": "published_traceable_archive" }, "names": { "brand": "Xalatan", "generic": "拉坦前列素", "aliases": [ "latanoprost" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "眼科健康", "sourceArchiveMarket": "美国 XALATAN 公开标签（2023-05-15 生效；DailyMed SPL v2 于 2024-10-25 发布）", "dosageFormClass": "眼用滴眼液：0.005%（50 mcg/mL）；本档案精确展示 NDC 58151-419-35、125 mcg/2.5 mL、一支 2.5 mL 瓶装", "dosageFormClassCode": "other", "route": "眼用", "routeCode": "other", "historicalApprovalEntry": "1996（DailyMed 美国公开标签所列初始批准）", "archiveSponsorText": "Viatris Specialty LLC / DailyMed（NLM）当前公开标签" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [ "XALATAN 5 mL", "XALATAN 0.005% 5 mL", "latanoprost 0.005% 5 mL" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-xalatan-latanoprost-ophthalmic-solution-0-005pct-58151-419-35", "marketCode": "US", "labelVersion": { "zh": "2023-05-15 生效；DailyMed SPL v2 于 2024-10-25 发布", "en": "effective 15 May 2023; DailyMed SPL v2 published 25 Oct 2024" }, "dosageForm": { "zh": "拉坦前列素眼用滴眼液", "en": "latanoprost ophthalmic solution" }, "route": { "zh": "眼用（仅作标签产品身份字段）", "en": "ophthalmic use (label product-identity field only)" }, "routeCodes": [ "ophthalmic" ], "productCode": "NDC 58151-419-35", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "concentration", "primaryDisplay": { "zh": "0.005%（50 mcg/mL）；125 mcg/2.5 mL；1 支 2.5 mL 瓶装", "en": "0.005% (50 mcg/mL); 125 mcg/2.5 mL; one 2.5 mL bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=a98595b3-9f47-48e0-b18d-550a2095f264&name=image-02.jpg", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "拉坦前列素", "en": "latanoprost" }, "value": 50, "unit": "mcg", "basisCode": "concentration", "basisLabel": { "zh": "标签浓度；不是个人滴数、频次或换算指令", "en": "labelled concentration; not an individual drop count, frequency or conversion instruction" } } ], "concentration": { "basisCode": "mass_per_volume", "notation": "50 mcg/mL (0.005%)", "numerator": { "value": 50, "unit": "mcg" }, "denominator": { "value": 1, "unit": "mL" }, "display": { "zh": "50 mcg/mL（0.005%；标签浓度）", "en": "50 mcg/mL (0.005%; labelled concentration)" } }, "container": { "typeCode": "dropper_bottle", "typeLabel": { "zh": "滴眼液瓶", "en": "ophthalmic dropper bottle" }, "fill": { "value": 2.5, "unit": "mL" }, "countPerPackage": 1, "countUnit": { "zh": "支/盒", "en": "bottle per carton" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-21", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 1, "unit": { "zh": "支 2.5 mL 瓶装/盒", "en": "2.5 mL bottle per carton" } }, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_8cc23d9dd2569529", "label": "DailyMed（NLM）：XALATAN 拉坦前列素当前美国公开标签与精确 2.5 mL 纸盒面板（Viatris Specialty LLC；SPL v2）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=a98595b3-9f47-48e0-b18d-550a2095f264&version=2", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-xalatan-latanoprost-ophthalmic-solution-0-005pct-58151-419-35", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=a98595b3-9f47-48e0-b18d-550a2095f264&name=image-02.jpg", "alt": "XALATAN 拉坦前列素 0.005%（50 mcg/mL）、NDC 58151-419-35、2.5 mL 瓶装的美国 DailyMed 公开标签纸盒面板", "archiveMarket": "美国", "labelVersion": "DailyMed SPL v2（2024-10-25 发布）", "presentation": "XALATAN 眼用滴眼液：0.005%（50 mcg/mL）；NDC 58151-419-35；125 mcg/2.5 mL；一支 2.5 mL 瓶装纸盒面板。", "notice": "此图是 Viatris Specialty LLC 的美国 DailyMed SPL v2 公开纸盒面板，仅对应 0.005%（50 mcg/mL）、NDC 58151-419-35、125 mcg/2.5 mL 和一支 2.5 mL 瓶装；不用于鉴定真伪。它不代表 Pfizer 2022 标签档案、另一拉坦前列素包装、其他市场、其他浓度或任何个人滴数、储存、联用、漏用或转换方案。", "source": { "id": "src_8cc23d9dd2569529", "label": "DailyMed（NLM）：XALATAN 当前美国公开标签与精确 2.5 mL 纸盒面板（Viatris Specialty LLC；SPL v2，2024-10-25 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=a98595b3-9f47-48e0-b18d-550a2095f264&version=2", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "XALATAN 说明书放大阅读：0.005%、50 mcg/mL、2.5 mL 是不同身份字段", "en": "XALATAN label reading: 0.005%, 50 mcg/mL and 2.5 mL are different identity fields" }, "summary": { "zh": "本模块以美国 DailyMed 公开标签为阅读入口，帮助核对 XALATAN、拉坦前列素、0.005%/50 mcg/mL、2.5 mL 瓶装和眼用剂型。它不提供任何人的滴数、用药时间、漏用处理、联用、转换或眼压处理方案。", "en": "This module uses the U.S. DailyMed public label to check XALATAN, latanoprost, 0.005%/50 mcg/mL, a 2.5 mL bottle and ophthalmic use. It does not provide an individual's drop count, timing, missed-use handling, combination, switching or eye-pressure-management plan." }, "checks": [ { "zh": "0.005% 与 50 mcg/mL 是同一滴眼液浓度的两种标签写法；2.5 mL 是该瓶的标示容量。它们用于确认准确产品，不是网页给任何人计算应滴几滴、能用多久或能否补用的答案。", "en": "0.005% and 50 mcg/mL are two label formats for the concentration of this eye-drop solution; 2.5 mL is the stated bottle volume. They help identify the exact product, not calculate how many drops anyone should use, how long it lasts or whether to make up use." }, { "zh": "眼用滴眼液不能仅因都写有“青光眼”“眼压”或“滴眼液”而自行混用、轮换或替代。该标签对与其他前列腺素类眼用产品、其他滴眼液和隐形眼镜有具体核对事项；应带实际药瓶和完整眼用/全身用药清单请眼科医生或药师核对。", "en": "Eye drops cannot be self-combined, alternated or substituted merely because they mention glaucoma, eye pressure or eye drops. This label has specific checks involving other prostaglandin eye products, other drops and contact lenses; have an ophthalmologist or pharmacist review the actual bottles and complete eye/systemic medicine list." }, { "zh": "滴眼液瓶、盖子、容量和标签图只帮助识别来源，不能验证真伪、确认是否为另一种拉坦前列素包装，或确认当前储存与使用要求。打开、储存、与其他滴眼液间隔、隐形眼镜及任何漏用问题，都必须按手上准确产品的现行标签和专业人员说明处理。", "en": "A dropper bottle, cap, volume and label image only help identify a source. They cannot authenticate a product, show that it is another latanoprost presentation or confirm current storage and handling requirements. Opening, storage, spacing from another eye drop, contact lenses and missed-use questions must follow the current label and professional instructions for the exact product in hand." }, { "zh": "标签列有虹膜、眼周组织/睫毛变化、眼内炎症、黄斑水肿及感染等警示。出现视力变化、明显眼痛、红肿、外伤或任何急性眼部问题时，应及时使用当地眼科或紧急医疗渠道；网页不判断是否自行继续、暂停或换药。", "en": "The label includes warnings about iris, periocular tissue/eyelash changes, intraocular inflammation, macular oedema and infection. With vision change, marked eye pain, redness/swelling, injury or another acute eye concern, use local ophthalmic or urgent-care pathways promptly; this page does not decide self-continuation, pause or switching." } ], "source": { "id": "src_5cc92379c2974805", "label": "DailyMed（NLM）：XALATAN 拉坦前列素公开标签（Pfizer，2022-12 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=f4e73059-5ba0-4d73-9ea1-09d8d654e844", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "拉坦前列素怎样起作用：标签将其归为前列腺素 F2α 类似物", "en": "How latanoprost works: the label classifies it as a prostaglandin F2α analogue" }, "summary": { "zh": "DailyMed 标签将 XALATAN 描述为前列腺素 F2α 类似物，用于降低开角型青光眼或高眼压患者升高的眼内压。这解释标签中的药理类别与用途边界，不判断任何人的眼压原因、是否适用、滴数、联用或转换方案。", "en": "The DailyMed label describes XALATAN as a prostaglandin F2α analogue for reducing elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension. This explains a class and labelled-use boundary; it does not determine anyone's cause of eye pressure, suitability, drop count, combination or switching plan." }, "checks": [ { "zh": "“前列腺素 F2α 类似物”是药理类别，不是凭症状、一次眼压值或眼药水外观判断是否需要用药的依据。青光眼和高眼压相关评估仍需要眼科检查、现行标签和专业人员判断。", "en": "“Prostaglandin F2α analogue” is a pharmacologic class, not a basis for deciding a need for treatment from symptoms, one pressure reading or eye-drop appearance. Glaucoma and ocular-hypertension assessment still requires an eye examination, the current label and professional judgement." }, { "zh": "共同属于前列腺素相关眼用产品，不使 XALATAN 与另一种同类滴眼液可自行叠加、轮换、替换或按浓度换算。完整眼用和全身药单、实际产品、既往眼部反应与检查计划都应一起交由专业人员核对。", "en": "A shared prostaglandin-related eye-product class does not make XALATAN self-combinable, alternatable, substitutable or concentration-convertible with another related drop. The complete eye/systemic medicine list, actual products, prior eye reactions and examination plan need professional review together." }, { "zh": "机制页面不能把“降低眼压”转换成对视物模糊、疼痛、发红、手术前后或突然视力变化的个人处理方案。遇到急性或严重眼部问题，应优先联系当地眼科与紧急医疗支持，而不是依据本页自行调整。", "en": "A mechanism page cannot turn “lowers eye pressure” into personal management for blurred vision, pain, redness, before/after procedures or sudden vision change. With an acute or serious eye concern, prioritise local ophthalmic and urgent medical support rather than self-adjusting from this page." } ], "source": { "id": "src_d6d95eb61be4fd6a", "label": "FDA：XALATAN 2022 美国处方信息（NDA 020597）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020597s054lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "Xalatan", "generic": "拉坦前列素", "dosageFormClass": "眼用滴眼液：0.005%（50 mcg/mL）；本档案精确展示 NDC 58151-419-35、125 mcg/2.5 mL、一支 2.5 mL 瓶装" }, "labelSource": { "id": "src_5cc92379c2974805", "label": "DailyMed（NLM）：XALATAN 拉坦前列素公开标签（Pfizer，2022-12 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=f4e73059-5ba0-4d73-9ea1-09d8d654e844", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "productRoutes": [ { "source": { "id": "src_5cc92379c2974805", "label": "DailyMed（NLM）：XALATAN 拉坦前列素公开标签（Pfizer，2022-12 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=f4e73059-5ba0-4d73-9ea1-09d8d654e844", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_d6d95eb61be4fd6a", "label": "FDA：XALATAN 2022 美国处方信息（NDA 020597）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020597s054lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "本页精确建立美国 XALATAN（latanoprost）0.005%（50 mcg/mL）、NDC 58151-419-35、125 mcg/2.5 mL、一支 2.5 mL 瓶装的标签阅读身份。浓度、瓶内标示总量和容器容量是不同字段；不得据此自行计算滴数、使用频次、储存、联用、转换或眼压处理方案。", "history": "本档案链接的 DailyMed 页面是美国公开标签阅读入口，页面所列包装商为 Viatris Specialty LLC。标签版本、包装、冷藏/储存文字和眼用操作要求都只对应所引产品；不据此推定中国大陆或其他市场的当前批准、持有人、可获得性、价格、原研/仿制关系或可售资格。", "sourceDocuments": [ { "id": "src_5cc92379c2974805", "label": "DailyMed（NLM）：XALATAN 拉坦前列素公开标签（Pfizer，2022-12 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=f4e73059-5ba0-4d73-9ea1-09d8d654e844", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_d6d95eb61be4fd6a", "label": "FDA：XALATAN 2022 美国处方信息（NDA 020597）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020597s054lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_5ed30b676fbb9773", "label": "FDA Drugs@FDA 官方检索入口", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_lookup_entry", "documentKind": "regulatory_lookup", "market": "US", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } ], "applicationNumber": "NDA 020597", "approvalTimeline": [ { "date": "1996", "title": { "zh": "FDA 标签所列美国初始批准年份", "en": "Initial U.S. approval year listed in the FDA label" }, "detail": { "zh": "本页链接的 FDA 标签档案列示 Initial U.S. Approval: 1996。该历史定位不等同于当前批准、可得性、持有人或其他市场状态。", "en": "The FDA label archive linked here lists Initial U.S. Approval: 1996. This historical locator is not a conclusion about current approval, availability, holder or another market." }, "source": { "id": "src_5cc92379c2974805", "label": "DailyMed: XALATAN public label archive", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=f4e73059-5ba0-4d73-9ea1-09d8d654e844", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, { "date": "2022-12", "title": { "zh": "FDA 标签档案版本", "en": "FDA label archive version" }, "detail": { "zh": "本页链接 2022-12 的 FDA 标签档案作为可复核阅读入口。现行标签、规格、适应症和安全信息必须另行以目标市场当前文件核对。", "en": "This page links the 2022-12 FDA label archive as a traceable reading entry point. Current labeling, strength, indication and safety information require separate verification against the target market’s current document." }, "source": { "id": "src_5cc92379c2974805", "label": "DailyMed: XALATAN public label archive", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=f4e73059-5ba0-4d73-9ea1-09d8d654e844", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "已链接公开标签档案", "en": "Public label archive linked" }, "detail": { "zh": "仅对应本页所列 FDA 文件。", "en": "Only the FDA document listed on this page is linked." } }, { "market": { "zh": "中国大陆、欧盟、日本", "en": "Mainland China, EU, Japan" }, "status": { "zh": "待逐项建立市场记录", "en": "Market record not established" }, "detail": { "zh": "不从美国标签档案推定当地批准、持有人、规格、供应或可售资格。", "en": "No local approval, holder, strength, supply or sale-eligibility conclusion is inferred from the U.S. label archive." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "标签档案能代表现在的产品信息吗？", "en": "Does a label archive represent current product information?" }, "answer": { "zh": "不能自动代表。档案用于定位来源；需要以目标市场的现行官方标签逐项复核。", "en": "Not automatically. The archive locates a source; each point needs verification against the target market’s current official label." } }, { "question": { "zh": "为什么这里不展示价格或原研/仿制结论？", "en": "Why are price and originator/generic conclusions not shown?" }, "answer": { "zh": "这些结论需要产品、剂型、规格、包装、市场、日期和原始记录分别齐全并经人工审核；单一标签文件不足以支持。", "en": "Those conclusions require separately complete and human-reviewed product, dosage-form, strength, pack, market, date and primary-record fields; one label file is insufficient." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "how-to-read-a-drug-label", "regulatory-sources-first" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/xalatan/", "en": "https://origindrug.com/en/drugs/xalatan/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "lumigan", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-22", "status": "published_traceable_archive" }, "names": { "brand": "Lumigan", "generic": "比马前列素", "aliases": [ "bimatoprost" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": { "value": "卢美根®", "status": "discovery_cue_requires_target_market_verification", "source": { "id": "src_210742865baabc7a", "label": "国家人口健康科学数据中心药学数据中心：贝美前列素滴眼液／卢美根历史注册资料", "url": "https://pharm.ncmi.cn/zysjk/ypjkyp/202312/t20231205_398786.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "regulatory_product_record", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-28", "reviewedAt": "2026-08-28" } } }, "identity": { "therapeuticArea": "眼科健康", "sourceArchiveMarket": "美国 DailyMed 当前公开标签（SPL v19，2026-07-28 发布；本档案精确展示 0.01% 纸盒面板）", "dosageFormClass": "眼用滴眼液：0.01%（0.1 mg/mL）；本档案精确展示 5 mL fill in 10 mL container（NDC 0023-3205-05）", "dosageFormClassCode": "other", "route": "眼用", "routeCode": "other", "historicalApprovalEntry": "2010-08-31（LUMIGAN 0.01% FDA NDA 022184 原始申请批准）", "archiveSponsorText": "Allergan / AbbVie；DailyMed（NLM）美国公开标签" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-lumigan-bimatoprost-001pct-5ml-ndc-0023-3205-05", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v19（2026-07-28 发布）", "en": "DailyMed SPL v19 (published 28 Jul 2026)" }, "dosageForm": { "zh": "LUMIGAN 比马前列素眼用滴眼液", "en": "LUMIGAN bimatoprost ophthalmic solution" }, "route": { "zh": "眼用", "en": "ophthalmic" }, "routeCodes": [ "ophthalmic" ], "productCode": "NDC 0023-3205-05", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_mL", "primaryDisplay": { "zh": "0.01%（0.1 mg/mL）；10 mL 瓶内实装 5 mL", "en": "0.01% (0.1 mg/mL); 5 mL fill in a 10 mL container" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=a5e67c75-db88-4372-bb07-c8dd15c97631&name=lumigan-01-03.jpg", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "比马前列素", "en": "bimatoprost" }, "value": 0.1, "unit": "mg/mL", "basisCode": "per_mL", "basisLabel": { "zh": "标签浓度；不是个人滴数", "en": "labelled concentration; not an individual drop count" } } ], "concentration": null, "container": { "typeCode": "dropper_bottle", "typeLabel": { "zh": "10 mL 滴眼瓶", "en": "10 mL dropper bottle" }, "fill": { "value": 5, "unit": "mL" }, "countPerPackage": null, "countUnit": null }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-28", "currentLabelDisplayed": true, "ndcDirectoryListed": false, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 1, "unit": { "zh": "瓶/盒", "en": "bottle per carton" } }, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_22609ba5da0890b9", "label": "DailyMed（NLM）：LUMIGAN 0.01%、5 mL、NDC 0023-3205-05 当前美国标签面板", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a5e67c75-db88-4372-bb07-c8dd15c97631", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": null, "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=a5e67c75-db88-4372-bb07-c8dd15c97631&name=lumigan-01-03.jpg", "alt": "LUMIGAN 比马前列素 0.01%（0.1 mg/mL）、NDC 0023-3205-05、5 mL fill in 10 mL container 的美国 DailyMed 公开标签纸盒面板", "archiveMarket": "美国", "labelVersion": "DailyMed SPL v19（2026-07-28 发布）", "presentation": "LUMIGAN 眼用滴眼液：0.01%（0.1 mg/mL）；NDC 0023-3205-05；5 mL fill in a 10 mL container；精确美国公开纸盒面板。", "notice": "此图是 Allergan / AbbVie 的美国 DailyMed SPL v19 公开纸盒面板，仅对应 LUMIGAN、比马前列素 0.01%（0.1 mg/mL）、NDC 0023-3205-05 与 5 mL fill in a 10 mL container；不用于鉴定真伪。它不代表其他 NDC、其他容量、其他市场、当前可得性、原研身份、可替代性或任何个人滴数、储存、联用、漏用或转换方案。", "source": { "id": "src_22609ba5da0890b9", "label": "DailyMed（NLM）：LUMIGAN 当前美国公开标签与精确 5 mL 纸盒面板（Allergan；SPL v19，2026-07-28 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a5e67c75-db88-4372-bb07-c8dd15c97631", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "LUMIGAN 说明书放大阅读：0.01%、0.1 mg/mL 与 5 mL 是不同身份字段", "en": "LUMIGAN label reading: 0.01%, 0.1 mg/mL and 5 mL are different identity fields" }, "summary": { "zh": "本模块以美国 DailyMed 公开标签为阅读入口，帮助核对 LUMIGAN、比马前列素、0.01%/0.1 mg/mL、精确 5 mL 容器面板和眼用剂型。它不提供任何人的滴数、时间、漏用处理、联用、转换或眼压处理方案。", "en": "This module uses the U.S. DailyMed public label to check LUMIGAN, bimatoprost, 0.01%/0.1 mg/mL, the exact 5 mL container panel and ophthalmic use. It does not provide an individual's drop count, timing, missed-use handling, combination, switching or eye-pressure-management plan." }, "checks": [ { "zh": "0.01% 与 0.1 mg/mL 是同一滴眼液浓度的两种标签写法；5 mL 是该精确面板所示容器的填充量，10 mL 是容器标示容量。它们用于确认产品，不是网页给任何人计算应滴几滴、能用多久或能否补用的答案。", "en": "0.01% and 0.1 mg/mL are two label formats for the concentration of this eye-drop solution; 5 mL is the fill volume of this exact panel and 10 mL is the stated container size. They help identify the product, not calculate how many drops anyone should use, how long it lasts or whether to make up use." }, { "zh": "眼用滴眼液不能仅因都写有“青光眼”“眼压”或“前列腺素”而自行混用、轮换或替代。标签对其他前列腺素类眼用产品、其他滴眼液和隐形眼镜有特定核对事项；应带实际药瓶和完整眼用/全身药单请眼科医生或药师核对。", "en": "Eye drops cannot be self-combined, alternated or substituted merely because they mention glaucoma, eye pressure or prostaglandins. The label has product-specific checks involving other prostaglandin eye products, other drops and contact lenses; have an ophthalmologist or pharmacist review the actual bottles and complete eye/systemic medicine list." }, { "zh": "包装图、NDC、填充量和容器容量只帮助比对来源，不能验证真伪、确认另一种比马前列素包装，或确认当前储存与使用要求。任何开封、储存、与其他滴眼液间隔、隐形眼镜或漏用问题，都必须按手上准确产品的现行标签和专业人员说明处理。", "en": "The package image, NDC, fill volume and container size only help compare a source. They cannot authenticate a product, identify another bimatoprost package or confirm current storage and handling requirements. Any opening, storage, spacing from another eye drop, contact-lens or missed-use question must follow the current label and professional instructions for the exact product in hand." }, { "zh": "标签列有虹膜、眼睑/睫毛变化、眼内炎症、黄斑水肿与细菌性角膜炎等警示。出现视力变化、明显眼痛、红肿、外伤或任何急性眼部问题时，应及时使用当地眼科或紧急医疗渠道；网页不判断是否自行继续、暂停或换药。", "en": "The label includes warnings about iris, eyelid/eyelash changes, intraocular inflammation, macular oedema and bacterial keratitis. With vision change, marked eye pain, redness/swelling, injury or another acute eye concern, use local ophthalmic or urgent-care pathways promptly; this page does not decide self-continuation, pause or switching." } ], "source": { "id": "src_22609ba5da0890b9", "label": "DailyMed（NLM）：LUMIGAN 比马前列素当前美国公开标签（Allergan；SPL v19，2026-07-28 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a5e67c75-db88-4372-bb07-c8dd15c97631", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "比马前列素怎样起作用：标签描述其与房水外流路径有关", "en": "How bimatoprost works: the label describes an association with aqueous-humour outflow pathways" }, "summary": { "zh": "DailyMed 标签将比马前列素描述为具有降低眼内压活性的前列酰胺结构类似物，并说明其被认为与经小梁网和葡萄膜巩膜路径增加房水外流有关。该机制帮助理解药理路径，不判断任何人的眼压原因、是否适用、滴数、联用或转换方案。", "en": "The DailyMed label describes bimatoprost as a structural prostamide analogue with ocular-hypotensive activity and states that it is believed to increase aqueous-humour outflow through trabecular-meshwork and uveoscleral pathways. This explains a pharmacologic pathway; it does not determine anyone's cause of eye pressure, suitability, drop count, combination or switching plan." }, "checks": [ { "zh": "“与房水外流有关”解释的是药理路径，不是凭症状、一次眼压数值或药瓶外观判断是否需要用药的依据。青光眼和高眼压相关评估仍需要眼科检查、现行标签和专业人员判断。", "en": "“Associated with aqueous-humour outflow” explains a pharmacologic pathway, not a basis for deciding a need for treatment from symptoms, one pressure value or bottle appearance. Glaucoma and ocular-hypertension assessment still requires an eye examination, the current label and professional judgement." }, { "zh": "共同属于前列腺素或相关眼用产品，不使 LUMIGAN 与另一种滴眼液可自行叠加、轮换、替换或按浓度换算。完整眼用和全身药单、实际产品、既往眼部反应与检查计划都应一起交由专业人员核对。", "en": "A shared prostaglandin-related eye-product description does not make LUMIGAN self-combinable, alternatable, substitutable or concentration-convertible with another drop. The complete eye/systemic medicine list, actual products, prior eye reactions and examination plan need professional review together." }, { "zh": "机制页面不能把“降低眼压”转换成对视物模糊、疼痛、发红、手术前后或突然视力变化的个人处理方案。遇到急性或严重眼部问题，应优先联系当地眼科与紧急医疗支持，而不是依据本页自行调整。", "en": "A mechanism page cannot turn “lowers eye pressure” into personal management for blurred vision, pain, redness, before/after procedures or sudden vision change. With an acute or serious eye concern, prioritise local ophthalmic and urgent medical support rather than self-adjusting from this page." } ], "source": { "id": "src_22609ba5da0890b9", "label": "DailyMed（NLM）：LUMIGAN 比马前列素当前美国公开标签（Clinical Pharmacology；SPL v19，2026-07-28 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a5e67c75-db88-4372-bb07-c8dd15c97631", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "Lumigan", "generic": "比马前列素", "dosageFormClass": "眼用滴眼液：0.01%（0.1 mg/mL）；本档案精确展示 5 mL fill in 10 mL container（NDC 0023-3205-05）" }, "labelSource": { "id": "src_22609ba5da0890b9", "label": "DailyMed（NLM）：LUMIGAN 比马前列素当前美国公开标签（Allergan；SPL v19，2026-07-28 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a5e67c75-db88-4372-bb07-c8dd15c97631", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "productRoutes": [ { "source": { "id": "src_22609ba5da0890b9", "label": "DailyMed（NLM）：LUMIGAN 比马前列素当前美国公开标签（Allergan；SPL v19，2026-07-28 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a5e67c75-db88-4372-bb07-c8dd15c97631", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "DailyMed 的 LUMIGAN（bimatoprost）美国公开标签将其列为 0.01%（0.1 mg/mL）眼用滴眼液。此页帮助把品牌、通用名、浓度、精确容器面板、眼用剂型和目标市场一起核对；不据此生成个人滴数、时间、漏用处理、联用、转换或眼压处理方案。", "history": "本页的精确 0.01% 面板对应 FDA NDA 022184（原始申请于 2010-08-31 获批）。FDA 的 NDA 021275 则对应 0.03% 的 2001 历史记录，不能以品牌或通用名把两种浓度、批准记录或包装自动合并。此处建立的是美国公开标签阅读入口，不能据此推定中国大陆或其他市场的当前批准、持有人、可获得性、价格、原研/仿制关系或可售资格。", "sourceDocuments": [ { "id": "src_22609ba5da0890b9", "label": "DailyMed（NLM）：LUMIGAN 比马前列素当前美国公开标签（Allergan；SPL v19，2026-07-28 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a5e67c75-db88-4372-bb07-c8dd15c97631", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_d40822b50afd9241", "label": "FDA：LUMIGAN 0.01% NDA 022184 原始申请批准函（2010-08-31）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022184s000ltr.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "approval_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_3545e9938960e517", "label": "FDA：LUMIGAN 0.03% NDA 021275 历史审批行政资料（2001；不代表本页 0.01% 面板）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21275_Lumigan%200.03%20percent%20Opthalmis%20Solution_admindocs.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "approval_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_5ed30b676fbb9773", "label": "FDA Drugs@FDA 官方检索入口", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_lookup_entry", "documentKind": "regulatory_lookup", "market": "US", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } ], "applicationNumber": "NDA 022184 (0.01% current label panel)", "approvalTimeline": [ { "date": "2001-03-16", "title": { "zh": "LUMIGAN 0.03% 的历史原始批准", "en": "Historical original approval for LUMIGAN 0.03%" }, "detail": { "zh": "FDA Drugs@FDA 记录 NDA 021275 的 0.03% 原始申请于 2001-03-16 获批。该节点仅用于说明它与本页 0.01% 面板不同，不能把两种浓度或包装自动合并。", "en": "FDA Drugs@FDA records approval of the original 0.03% application, NDA 021275, on 16 Mar 2001. This node only distinguishes it from the 0.01% panel on this page; it does not merge the concentrations or packages." }, "source": { "id": "src_3545e9938960e517", "label": "FDA: LUMIGAN 0.03% NDA 021275 historical approval materials (2001)", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21275_Lumigan%200.03%20percent%20Opthalmis%20Solution_admindocs.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "approval_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, { "date": "2010-08-31", "title": { "zh": "LUMIGAN 0.01% NDA 022184 原始申请批准", "en": "LUMIGAN 0.01% NDA 022184 original application approval" }, "detail": { "zh": "FDA Drugs@FDA 公开记录将 0.01% 的原始申请（ORIG 1）标为 2010-08-31 获批；这是本页精确 0.01% 面板对应的监管节点。", "en": "The FDA Drugs@FDA public record lists original application ORIG 1 for 0.01% as approved on 31 Aug 2010; this is the regulatory node for the exact 0.01% panel on this page." }, "source": { "id": "src_d40822b50afd9241", "label": "FDA: LUMIGAN 0.01% NDA 022184 original approval letter (2010-08-31)", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022184s000ltr.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "approval_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, { "date": "2026-07-28", "title": { "zh": "DailyMed 当前 SPL v19 公开", "en": "Current SPL v19 published on DailyMed" }, "detail": { "zh": "DailyMed 将当前 LUMIGAN SPL v19 的 Published Date 列为 2026-07-28；该公开日期不代表实际在售、库存或其他市场状态。", "en": "DailyMed lists 28 Jul 2026 as the Published Date for current LUMIGAN SPL v19; it does not establish actual marketing, stock or another-market status." }, "source": { "id": "src_22609ba5da0890b9", "label": "DailyMed: current LUMIGAN 0.01% public label, SPL v19", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a5e67c75-db88-4372-bb07-c8dd15c97631", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "已链接公开标签档案", "en": "Public label archive linked" }, "detail": { "zh": "仅对应本页所列 FDA 文件。", "en": "Only the FDA document listed on this page is linked." } }, { "market": { "zh": "中国大陆、欧盟、日本", "en": "Mainland China, EU, Japan" }, "status": { "zh": "待逐项建立市场记录", "en": "Market record not established" }, "detail": { "zh": "不从美国标签档案推定当地批准、持有人、规格、供应或可售资格。", "en": "No local approval, holder, strength, supply or sale-eligibility conclusion is inferred from the U.S. label archive." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "标签档案能代表现在的产品信息吗？", "en": "Does a label archive represent current product information?" }, "answer": { "zh": "不能自动代表。档案用于定位来源；需要以目标市场的现行官方标签逐项复核。", "en": "Not automatically. The archive locates a source; each point needs verification against the target market’s current official label." } }, { "question": { "zh": "为什么这里不展示价格或原研/仿制结论？", "en": "Why are price and originator/generic conclusions not shown?" }, "answer": { "zh": "这些结论需要产品、剂型、规格、包装、市场、日期和原始记录分别齐全并经人工审核；单一标签文件不足以支持。", "en": "Those conclusions require separately complete and human-reviewed product, dosage-form, strength, pack, market, date and primary-record fields; one label file is insufficient." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "how-to-read-a-drug-label", "regulatory-sources-first" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/lumigan/", "en": "https://origindrug.com/en/drugs/lumigan/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }, { "id": "restasis", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-22", "status": "published_traceable_archive" }, "names": { "brand": "Restasis", "generic": "环孢素", "aliases": [ "cyclosporine ophthalmic emulsion" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "眼科健康", "sourceArchiveMarket": "美国公开处方药标签档案（DailyMed 页面 2024-09-09 更新；SPL v19 于 2024-12-30 发布）", "dosageFormClass": "眼用乳剂：0.05%（0.5 mg/mL）；精确展示 30 支、60 支单剂量小瓶纸盒面板；不并入 RESTASIS MULTIDOSE 5.5 mL 瓶", "dosageFormClassCode": "other", "route": "眼用", "routeCode": "other", "historicalApprovalEntry": "2002-12-23（FDA RESTASIS NDA 21-023 原始批准信）", "archiveSponsorText": "Allergan, Inc. / DailyMed（NLM）公开标签档案" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [ "RESTASIS MULTIDOSE", "RESTASIS MultiDose", "RESTASIS 5.5 mL", "cyclosporine ophthalmic emulsion 5.5 mL" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-restasis-cyclosporine-ophthalmic-emulsion-0-05pct-0023916330", "marketCode": "US", "labelVersion": { "zh": "DailyMed 页面 2024-09-09 更新；SPL v19 于 2024-12-30 发布", "en": "DailyMed updated 9 Sep 2024; SPL v19 published 30 Dec 2024" }, "dosageForm": { "zh": "环孢素眼用乳剂（单剂量小瓶）", "en": "cyclosporine ophthalmic emulsion (single-use vial)" }, "route": { "zh": "眼用（仅作标签产品身份字段）", "en": "ophthalmic use (label product-identity field only)" }, "routeCodes": [ "ophthalmic" ], "productCode": "NDC 0023-9163-30", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "concentration", "primaryDisplay": { "zh": "0.05%（0.5 mg/mL）；每支 0.4 mL 单剂量小瓶；30 支纸盒", "en": "0.05% (0.5 mg/mL); 0.4 mL per single-use vial; 30-vial carton" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=8e24af2b-bc1c-4849-94f2-6df950cdca89&name=restasis-04.jpg", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "环孢素", "en": "cyclosporine" }, "value": 0.5, "unit": "mg", "basisCode": "concentration", "basisLabel": { "zh": "标签浓度；不是个人滴数、频次、开封处理或换算指令", "en": "labelled concentration; not an individual drop count, frequency, after-opening handling or conversion instruction" } } ], "concentration": { "basisCode": "mass_per_volume", "notation": "0.5 mg/mL (0.05%)", "numerator": { "value": 0.5, "unit": "mg" }, "denominator": { "value": 1, "unit": "mL" }, "display": { "zh": "0.5 mg/mL（0.05%；标签浓度）", "en": "0.5 mg/mL (0.05%; labelled concentration)" } }, "container": { "typeCode": "single_use_vial", "typeLabel": { "zh": "单剂量小瓶", "en": "single-use vial" }, "fill": { "value": 0.4, "unit": "mL" }, "countPerPackage": 30, "countUnit": { "zh": "支/盒", "en": "vials per carton" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-21", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 30, "unit": { "zh": "支单剂量小瓶/盒", "en": "single-use vials per carton" } }, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_ab443e9e305cfc9a", "label": "DailyMed（NLM）：RESTASIS 环孢素眼用乳剂 30 支单剂量小瓶精确美国公开纸盒面板（Allergan；SPL v19）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8e24af2b-bc1c-4849-94f2-6df950cdca89", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-restasis-cyclosporine-ophthalmic-emulsion-0-05pct-0023916360", "marketCode": "US", "labelVersion": { "zh": "DailyMed 页面 2024-09-09 更新；SPL v19 于 2024-12-30 发布", "en": "DailyMed updated 9 Sep 2024; SPL v19 published 30 Dec 2024" }, "dosageForm": { "zh": "环孢素眼用乳剂（单剂量小瓶）", "en": "cyclosporine ophthalmic emulsion (single-use vial)" }, "route": { "zh": "眼用（仅作标签产品身份字段）", "en": "ophthalmic use (label product-identity field only)" }, "routeCodes": [ "ophthalmic" ], "productCode": "NDC 0023-9163-60", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "concentration", "primaryDisplay": { "zh": "0.05%（0.5 mg/mL）；每支 0.4 mL 单剂量小瓶；60 支纸盒", "en": "0.05% (0.5 mg/mL); 0.4 mL per single-use vial; 60-vial carton" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=8e24af2b-bc1c-4849-94f2-6df950cdca89&name=restasis-03.jpg", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "环孢素", "en": "cyclosporine" }, "value": 0.5, "unit": "mg", "basisCode": "concentration", "basisLabel": { "zh": "标签浓度；不是个人滴数、频次、开封处理或换算指令", "en": "labelled concentration; not an individual drop count, frequency, after-opening handling or conversion instruction" } } ], "concentration": { "basisCode": "mass_per_volume", "notation": "0.5 mg/mL (0.05%)", "numerator": { "value": 0.5, "unit": "mg" }, "denominator": { "value": 1, "unit": "mL" }, "display": { "zh": "0.5 mg/mL（0.05%；标签浓度）", "en": "0.5 mg/mL (0.05%; labelled concentration)" } }, "container": { "typeCode": "single_use_vial", "typeLabel": { "zh": "单剂量小瓶", "en": "single-use vial" }, "fill": { "value": 0.4, "unit": "mL" }, "countPerPackage": 60, "countUnit": { "zh": "支/盒", "en": "vials per carton" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-21", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 60, "unit": { "zh": "支单剂量小瓶/盒", "en": "single-use vials per carton" } }, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_ab443e9e305cfc9a", "label": "DailyMed（NLM）：RESTASIS 环孢素眼用乳剂 60 支单剂量小瓶精确美国公开纸盒面板（Allergan；SPL v19）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8e24af2b-bc1c-4849-94f2-6df950cdca89", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-restasis-cyclosporine-ophthalmic-emulsion-0-05pct-0023916360", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=8e24af2b-bc1c-4849-94f2-6df950cdca89&name=restasis-03.jpg", "alt": "RESTASIS 环孢素眼用乳剂 0.05%（0.5 mg/mL）、NDC 0023-9163-60、60 支单剂量小瓶的美国 DailyMed 公开标签纸盒面板", "archiveMarket": "美国", "labelVersion": "DailyMed SPL v19（2024-12-30 发布）", "presentation": "RESTASIS 眼用乳剂：0.05%（0.5 mg/mL）；NDC 0023-9163-60；60 支单剂量小瓶；精确美国公开纸盒面板。", "notice": "此图是 Allergan / AbbVie 的美国 DailyMed SPL v19 公开纸盒面板，仅对应 RESTASIS、环孢素眼用乳剂 0.05%（0.5 mg/mL）、NDC 0023-9163-60 与 60 支单剂量小瓶；不用于鉴定真伪。它不代表 RESTASIS MULTIDOSE、其他 NDC、其他容量、其他市场、当前可得性、原研身份、可替代性或任何个人滴数、开封、储存、联用、漏用或转换方案。", "source": { "id": "src_ab443e9e305cfc9a", "label": "DailyMed（NLM）：RESTASIS 当前美国公开标签与精确 60 支单剂量小瓶纸盒面板（Allergan；SPL v19，2024-12-30 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8e24af2b-bc1c-4849-94f2-6df950cdca89", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "RESTASIS 说明书放大阅读：0.05%、0.5 mg/mL 与单剂量小瓶是一起核对的身份线索", "en": "RESTASIS label reading: 0.05%, 0.5 mg/mL and single-use vials are identity clues checked together" }, "summary": { "zh": "本模块以美国 DailyMed 公开标签为阅读入口，帮助核对 RESTASIS、环孢素眼用乳剂、0.05%/0.5 mg/mL、每支 0.4 mL 的 30 支或 60 支单剂量小瓶纸盒面板和眼用剂型。它不提供任何人的滴数、时间、开封后处理、漏用、联用、转换或干眼治疗方案。", "en": "This module uses the U.S. DailyMed public label to check RESTASIS, cyclosporine ophthalmic emulsion, 0.05%/0.5 mg/mL, the exact 30- or 60-single-use-vial carton panels with 0.4 mL per vial, and ophthalmic use. It does not provide an individual's drop count, timing, after-opening handling, missed-use, combination, switching or dry-eye treatment plan." }, "checks": [ { "zh": "0.05% 与 0.5 mg/mL 是这一眼用乳剂浓度的两种标签写法；60 支单剂量小瓶是该精确纸盒的包装身份。它们用于确认阅读对象，不是网页给任何人计算每次应滴几滴、一天如何安排、开封后如何处理或能用多久的答案。", "en": "0.05% and 0.5 mg/mL are two label formats for the concentration of this ophthalmic emulsion; 60 single-use vials identify the package on this exact carton. They help identify what is being read, not calculate anyone's drop count, daily timing, after-opening handling or how long a pack lasts." }, { "zh": "RESTASIS 与 RESTASIS MULTIDOSE 不是本页可以仅凭相同品牌或通用名自动合并、替代或换算的同一个包装。眼用乳剂的容器、一次性/多次使用信息、标签版本和目标市场都要分别对照手上准确产品的现行标签和专业人员说明。", "en": "RESTASIS and RESTASIS MULTIDOSE are not packaging forms this page can automatically merge, substitute or convert merely from a shared brand or generic name. The ophthalmic-emulsion container, single- versus multiple-use information, label version and target market must each be checked against the current label for the exact product in hand and professional guidance." }, { "zh": "包装图、NDC、浓度和单剂量文字只帮助比对来源，不能验证真伪、确认另一种环孢素眼用产品，或确认当前开封、储存、隐形眼镜与其他滴眼液的操作要求。相关问题必须按手上准确产品的现行标签和专业人员说明处理。", "en": "The package image, NDC, concentration and single-use wording only help compare a source. They cannot authenticate a medicine, identify another cyclosporine eye product or confirm current handling, storage, contact-lens or other-eye-drop requirements. Those questions must follow the current label and professional instructions for the exact product in hand." }, { "zh": "标签提示眼部刺激/灼热感、眼部感染或外伤时需谨慎处理。出现视力变化、明显眼痛、红肿、外伤、分泌物变化或其他急性眼部问题时，应及时使用当地眼科或紧急医疗渠道；网页不判断是否自行继续、暂停或换药。", "en": "The label calls for care around eye irritation/burning, eye infection or injury. With vision change, marked eye pain, redness/swelling, injury, discharge change or another acute eye concern, use local ophthalmic or urgent-care pathways promptly; this page does not decide self-continuation, pause or switching." } ], "source": { "id": "src_ab443e9e305cfc9a", "label": "DailyMed（NLM）：RESTASIS 环孢素眼用乳剂公开标签（Allergan，2024-09 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8e24af2b-bc1c-4849-94f2-6df950cdca89", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "环孢素眼用乳剂怎样起作用：标签描述其为局部免疫调节相关作用，确切机制尚不清楚", "en": "How cyclosporine ophthalmic emulsion works: the label describes local immunomodulation and says the exact mechanism is not known" }, "summary": { "zh": "DailyMed 标签将 RESTASIS 描述为具有抗炎作用的局部免疫调节剂，并说明在相关干眼情形中被认为具有部分免疫调节作用、确切机制尚不清楚。这解释标签的药理边界，不判断任何人的干眼原因、是否适用、滴数、联用或转换方案。", "en": "The DailyMed label describes RESTASIS as a topical immunomodulator with anti-inflammatory effects and says it is thought to act as a partial immunomodulator in the labelled dry-eye context, while the exact mechanism is not known. This explains the label's pharmacologic boundary; it does not determine anyone's cause of dry eye, suitability, drop count, combination or switching plan." }, "checks": [ { "zh": "“免疫调节”“抗炎”是标签中的作用路径描述，不是从眼干、刺痛、红眼或一次检查结果就能判断是否需要该产品的依据。症状原因、眼表检查、既往眼病、其他滴眼液和目标市场现行标签都需要眼科专业人员一起核对。", "en": "“Immunomodulation” and “anti-inflammatory” describe a labelled action pathway; they do not determine a need for this product from dryness, stinging, red eye or one examination result. Symptom cause, ocular-surface examination, prior eye conditions, other drops and the current target-market label need joint ophthalmic review." }, { "zh": "同为环孢素、都与免疫或眼部炎症相关，不能证明口服环孢素、其他眼用产品或另一种干眼产品可自行叠加、轮换、替代或按浓度换算。剂型、给药途径、风险、完整眼用/全身药单和实际包装都必须逐项核对。", "en": "Sharing cyclosporine or an immune/ocular-inflammation context does not prove that oral cyclosporine, another eye product or another dry-eye product can be self-combined, alternated, substituted or concentration-converted. Dosage form, route, risks, the complete eye/systemic medicine list and actual packages must be checked item by item." }, { "zh": "机制页面不能处理突然视力变化、明显疼痛、外伤、感染担忧、手术前后或不确定如何使用准确容器的问题。出现急性或严重眼部问题，应优先联系当地眼科与紧急医疗支持，而不是依据本页自行调整。", "en": "A mechanism page cannot manage sudden vision change, marked pain, injury, infection concern, before/after procedures or uncertainty about the exact container. With an acute or serious eye concern, prioritise local ophthalmic and urgent medical support rather than self-adjusting from this page." } ], "source": { "id": "src_ab443e9e305cfc9a", "label": "DailyMed（NLM）：RESTASIS 环孢素眼用乳剂公开标签（Clinical Pharmacology；Allergan，2024-09 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8e24af2b-bc1c-4849-94f2-6df950cdca89", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "Restasis", "generic": "环孢素", "dosageFormClass": "眼用乳剂：0.05%（0.5 mg/mL）；精确展示 30 支、60 支单剂量小瓶纸盒面板；不并入 RESTASIS MULTIDOSE 5.5 mL 瓶" }, "labelSource": { "id": "src_ab443e9e305cfc9a", "label": "DailyMed（NLM）：RESTASIS 环孢素眼用乳剂公开标签（Allergan，2024-09 更新；营销申请号 NDA050790）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8e24af2b-bc1c-4849-94f2-6df950cdca89", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "productRoutes": [ { "source": { "id": "src_ab443e9e305cfc9a", "label": "DailyMed（NLM）：RESTASIS 环孢素眼用乳剂公开标签（Allergan，2024-09 更新；营销申请号 NDA050790）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8e24af2b-bc1c-4849-94f2-6df950cdca89", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "DailyMed 的 RESTASIS（cyclosporine ophthalmic emulsion）美国公开标签将其列为 0.05%（0.5 mg/mL）眼用乳剂，并展示 0.4 mL 单剂量小瓶的 30 支与 60 支精确纸盒面板。此页帮助把品牌、通用名、浓度、每支容量、包装数量、目标市场与说明书来源一起核对；不据此生成个人滴数、时间、开封处理、漏用、联用、转换或干眼处理方案。", "history": "FDA 于 2002-12-23 批准 RESTASIS 的原始申请 NDA 21-023；当前 DailyMed 标签的营销申请栏列示 NDA050790。两项均为美国公开记录中的不同标识，页面并不将其互换，也不据此推定中国大陆或其他市场的当前批准、商品名、包装、持有人、可获得性、原研/仿制关系或可售资格。", "sourceDocuments": [ { "id": "src_ab443e9e305cfc9a", "label": "DailyMed（NLM）：RESTASIS 环孢素眼用乳剂公开标签（Allergan，2024-09 更新；营销申请号 NDA050790）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8e24af2b-bc1c-4849-94f2-6df950cdca89", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_319e19bbcdf5163f", "label": "FDA：RESTASIS 原始批准信（NDA 21-023；2002-12-23）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/050790ltr.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "approval_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_fcc882baf79afdde", "label": "DailyMed（NLM）：RESTASIS MULTIDOSE 独立美国公开标签（仅作包装区分来源）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=7224d810-bb96-4682-a942-3355e6e8061a", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "documentRelation": "excluded_product_reference", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_5ed30b676fbb9773", "label": "FDA Drugs@FDA 官方检索入口", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_lookup_entry", "documentKind": "regulatory_lookup", "market": "US", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } ], "applicationNumber": "FDA 原始批准申请：NDA 21-023；当前 DailyMed 标签营销申请号：NDA050790", "approvalTimeline": [ { "date": "2002-12-23", "title": { "zh": "RESTASIS 原始美国批准", "en": "Original U.S. RESTASIS approval" }, "detail": { "zh": "FDA 原始批准信记录 RESTASIS（环孢素眼用乳剂 0.05%）的 NDA 21-023 于 2002-12-23 获批。当前 DailyMed 标签另列营销申请号 NDA050790；两项不应互换。该历史节点不自动说明其他市场的批准、供应或可售状态。", "en": "FDA's original approval letter records approval of RESTASIS (cyclosporine ophthalmic emulsion 0.05%) under NDA 21-023 on 23 Dec 2002. The current DailyMed label separately lists marketing application NDA050790; the two identifiers are not interchangeable. This historical node does not establish approval, supply or sale status in another market." }, "source": { "id": "src_319e19bbcdf5163f", "label": "FDA：RESTASIS 原始批准信（NDA 21-023；2002-12-23）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/050790ltr.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "approval_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, { "date": "2024-09-09", "title": { "zh": "DailyMed 当前标签页面更新", "en": "Current DailyMed label page updated" }, "detail": { "zh": "DailyMed 当前 RESTASIS 标签页面列示 2024-09-09 更新；页面不将此日期解释为个人用药、可得性或供应结论。", "en": "The current DailyMed RESTASIS label page lists an update on 9 Sep 2024; this page does not interpret that date as an individual-use, availability or supply conclusion." }, "source": { "id": "src_ab443e9e305cfc9a", "label": "DailyMed（NLM）：RESTASIS 环孢素眼用乳剂公开标签（Allergan，2024-09 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8e24af2b-bc1c-4849-94f2-6df950cdca89", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, { "date": "2024-12-30", "title": { "zh": "DailyMed 当前 SPL v19 公开", "en": "Current SPL v19 published on DailyMed" }, "detail": { "zh": "DailyMed 媒体目录列示 RESTASIS 当前 SPL v19 于 2024-12-30 发布。该日期不代表个人用药、包装供应或其他市场状态。", "en": "The DailyMed media listing shows the current RESTASIS SPL v19 published on 30 Dec 2024. That date does not represent individual use, package availability or another-market status." }, "source": { "id": "src_ab443e9e305cfc9a", "label": "DailyMed（NLM）：RESTASIS 当前美国公开标签与精确 60 支单剂量小瓶纸盒面板（Allergan；SPL v19，2024-12-30 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8e24af2b-bc1c-4849-94f2-6df950cdca89", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "已链接当前标签、FDA 原始批准资料与两张精确单剂量纸盒面板", "en": "Current label, FDA original-approval material and two exact single-use carton panels linked" }, "detail": { "zh": "两张展示面板仅对应 0.05%（0.5 mg/mL）、每支 0.4 mL 的 NDC 0023-9163-30（30 支）和 NDC 0023-9163-60（60 支）单剂量小瓶；不据此建立实际在售、库存、个人操作或 RESTASIS MULTIDOSE 状态。", "en": "The two display panels correspond only to 0.05% (0.5 mg/mL), 0.4 mL per vial, NDC 0023-9163-30 (30 vials) and NDC 0023-9163-60 (60 vials); they do not establish actual marketing, stock, individual handling or RESTASIS MULTIDOSE status." } }, { "market": { "zh": "中国大陆、欧盟、日本及其他市场", "en": "Mainland China, EU, Japan and other markets" }, "status": { "zh": "待逐项建立市场记录", "en": "Market record not established" }, "detail": { "zh": "不从美国标签推定当地商品名、批准、包装、供应、原研关系或可替代性。", "en": "No local trade name, approval, pack, supply, originator relationship or interchangeability is inferred from the U.S. label." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "0.05% 与 0.5 mg/mL 是不是两种不同浓度？", "en": "Are 0.05% and 0.5 mg/mL two different concentrations?" }, "answer": { "zh": "不是，它们是这个准确美国眼用乳剂浓度的两种标签写法；但这不把网页变成任何人的滴数、频次、开封后处理或转换计算器。", "en": "No. They are two label formats for the concentration of this exact U.S. ophthalmic emulsion; that does not turn this page into anyone's drop-count, frequency, after-opening-handling or conversion calculator." } }, { "question": { "zh": "RESTASIS 与 RESTASIS MULTIDOSE 能否只凭品牌名互换？", "en": "Can RESTASIS and RESTASIS MULTIDOSE be interchanged from the brand name alone?" }, "answer": { "zh": "不能。品牌名或通用名相同不足以判断容器、单剂量/多次使用信息、标签、包装和实际处理要求。请带手上准确产品和完整眼用/全身药单请专业人员核对。", "en": "No. A shared brand or generic name is insufficient to determine container, single- versus multiple-use information, label, package or actual handling requirements. Have a professional review the exact product in hand and the complete eye/systemic medicine list." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "dosage-forms-are-part-of-medicine-identity", "how-to-read-a-drug-label" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/restasis/", "en": "https://origindrug.com/en/drugs/restasis/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] } ] }